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<strong>Official</strong> <strong>Journal</strong> C <strong>227</strong> E http://europa.eu.int/eur-lex/en/archive/2003/ce<strong>227</strong>20030923en.html<br />

<strong>Official</strong> <strong>Journal</strong><br />

of the European Union<br />

English edition Information and Notices<br />

Notice No Contents Page<br />

2003/C <strong>227</strong> E/01 Appendices to Annexes IV, V, VII, VIII, IX, X, XI,<br />

XII, XIII and XIV of the Act concerning the<br />

conditions of accession of the Czech Republic, the<br />

Republic of Estonia, the Republic of Cyprus, the<br />

Republic of Latvia, the Republic of Lithuania, the<br />

Republic of Hungary, the Republic of Malta, the<br />

Republic of Poland, the Republic of Slovenia and the<br />

Slovak Republic and the adjustments to the Treaties<br />

on which the European Union is founded 1<br />

Appendix to Annex IV 2<br />

Appendix A referred to in Chapter 3, Section A,<br />

point 1 of Annex V 14<br />

Appendix B referred to in Chapter 3, Section A,<br />

point 2 of Annex V 19<br />

Appendix referred to in Chapter 1 of Annex VII 20<br />

Appendix A referred to in Chapter 4, Section B,<br />

Subsection I, point 1 of Annex VIII 104<br />

Appendix B referred to in Chapter 4, Section B,<br />

Subsection I, point 2 of Annex VIII 114<br />

Appendix A referred to in Chapter 1 of Annex IX 115<br />

Appendix B referred to in Chapter 5, Section B,<br />

Subsection I of Annex IX 438<br />

Appendix A referred to in Chapter 5, Section B,<br />

point 1 of Annex X 444<br />

Appendix B referred to in Chapter 5, Section B,<br />

point 2 of Annex X 449<br />

Appendix A referred to in Chapter 1, point 2 of<br />

Annex XI 450<br />

Appendix B referred to in Chapter 4, Section B,<br />

Subsection I, point 1 of Annex XI 762<br />

Appendix C referred to in Chapter 4, Section B,<br />

Subsection I, point 2 of Annex XI 762<br />

Appendix A referred to in Chapter 1, points 4 and 5<br />

of Annex XII 763<br />

ISSN 1725-2423<br />

C <strong>227</strong> E<br />

Volume 46<br />

23 September 2003<br />

1 of 2 04/01/2005 17:17


<strong>Official</strong> <strong>Journal</strong> C <strong>227</strong> E http://europa.eu.int/eur-lex/en/archive/2003/ce<strong>227</strong>20030923en.html<br />

EN<br />

Appendix B referred to in Chapter 6, Section B,<br />

Subsection I, point 1 of Annex XII 1392<br />

Appendix C referred to in Chapter 6, Section B,<br />

Subsection I, point 2 of Annex XII 1485<br />

Appendix A referred to in Chapter 1 of Annex XIII 1488<br />

Appendix B referred to in Chapter 5, Section B,<br />

Subsection I of Annex XIII 1652<br />

Appendix referred to in Chapter 5, Section B to<br />

Annex XIV 1654<br />

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2 of 2 04/01/2005 17:17


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1<br />

Appendices to Annexes IV, V, VII, VIII, IX, X, XI, XII, XIII and XIV of the Act concerning the<br />

conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus,<br />

the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta,<br />

the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to<br />

the Treaties on which the European Union is founded<br />

(2003/C <strong>227</strong> E/01)<br />

The Appendices are reproduced in full here. For the documents concerning the accession of the Czech<br />

Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of<br />

Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of<br />

Slovenia and the Slovak Republic to the European Union see OJ L 236, 23.9.2003, p. 1.


EN<br />

2 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Appendix to Annex IV (*)<br />

List of existing aid measures referred to in point 1(b) of the existing aid mechanism provided for in Chapter 3<br />

of Annex IV<br />

Note: The aid measures listed in this Appendix are only to be considered as existing aid for the purpose of the<br />

application of the existing aid mechanism set out in Annex IV to the extent that they do fall within the scope<br />

of its first paragraph.<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

CZ 1 2002 Investiční pobídka pro společnost Candy<br />

Elletrodomestici S.r.l.<br />

CZ 2 2002 Investiční pobídka pro společnost ARROW<br />

International CR, a.s.<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

2/06/2000 10 years<br />

2/06/2000 5 years<br />

CZ 6 2002 Investiční pobídka pro společnost Viscofán, a.s. 2/08/2000 10 years<br />

CZ 7 2002 Investiční pobídka pro společnost Foxteq Holdings<br />

Inc.<br />

CZ 8 2002 Programy vy´ zkumu a vy´ voje Ministerstva<br />

pru˚myslu a obchodu<br />

CZ 9 2002 Investiční pobídka pro společnost Rodenstock ČR,<br />

s.r.o.<br />

29/08/2000 10 years<br />

19/09/2000 31/12/2005<br />

9/08/2000 5 years<br />

CZ 10 2002 Investiční pobídka pro společnost Danone, a.s. 23/10/2000 5 years<br />

CZ 11 2002 Dotace na nápravu škod na zˇivotním prostrˇedí<br />

vlivem tězˇby<br />

27/09/2000 31/12/2006<br />

CZ 13 2002 Investiční pobídka pro společnost RAKO, a.s. 19/09/2000 5 years<br />

CZ 14 2002 Investiční pobídka pro společnost Precision<br />

Castports Corp.<br />

CZ 15 2002 Investiční pobídka pro společnost Saar-<br />

Gummiwerk GmbH.<br />

CZ 16 2002 Investiční pobídka pro společnost Aisan Industry<br />

Co., Ltd.<br />

CZ 18 2002 Investiční pobídka pro společnost Danzer<br />

Furnierwerke, GmbH.<br />

CZ 19 2002 Investiční pobídka pro společnost Nová Mosilana,<br />

a.s.<br />

CZ 20 2002 Investiční pobídka pro společnost TRUSTFIN-<br />

Vanguard, a.s.<br />

CZ 21 2002 Investiční pobídka pro společnost Otis<br />

International Holdings GmbH.<br />

CZ 22 2002 Investiční pobídka pro společnost Infineon<br />

Technologies Trutnov, s.r.o.<br />

CZ 23 2002 Investiční pobídka pro společnost Prowell<br />

Papierverarbeitung GmbH.<br />

CZ 24 2002 Investiční pobídka pro společnost Siemens<br />

Automobilové závody, s.r.o.<br />

CZ 25 2002 Investiční pobídka pro společnost Pittsburgh<br />

Corning Europe, N.V.<br />

(*) For the text of Annex IV see OJ L 236, 23.9.2003, p. 797.<br />

5/09/2000 10 years<br />

7/09/2000 10 years<br />

7/11/2000 10 years<br />

5/10/2000 10 years<br />

2/11/2000 10 years<br />

10/11/2000 5 years<br />

8/09/2000 10 years<br />

23/10/2000 10 years<br />

24/10/2000 10 years<br />

10/11/2000 5 years<br />

10/10/2000 10 years


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 3<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

CZ 26 2002 Investiční pobídka pro společnost Bekaert-ZˇDB<br />

Building Products, s.r.o.<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

15/11/2000 5 years<br />

CZ 27 2002 Investiční pobídka pro společnost Textron, a.s. 28/11/2000 10 years<br />

CZ 28 2002 Investiční pobídka pro společnost Daiho Industrial<br />

CO., Ltd.<br />

CZ 29 2002 Investiční pobídka pro společnost DURA<br />

Automotive CZ, s.r.o.<br />

CZ 30 2002 Investiční pobídka pro společnost Karlovarské<br />

minerální vody, a.s.<br />

CZ 32 2002 Investiční pobídka pro společnost Magnesium<br />

Elektron Ltd.<br />

CZ 33 2002 Investiční pobídka pro společnost Continental<br />

Teves CR, s.r.o.<br />

16/11/2000 10 years<br />

22/11/2000 5 years<br />

28/11/2000 5 years<br />

27/11/2000 10 years<br />

28/11/2000 5 years<br />

CZ 34 2002 Investiční pobídka pro společnost Lovochemie, a.s. 15/01/2001 5 years<br />

CZ 35 2002 Investiční pobídka pro společnost ONTEX CZ,<br />

s.r.o.<br />

CZ 36 2002 Plošné a regionální programy podpory malého a<br />

strˇedního podnikání<br />

CZ 37 2002 Investiční pobídka pro společnost METAL Ústí<br />

nad Labem, a.s.<br />

CZ 38 2002 Investiční pobídka pro společnost ESAB Vamberk,<br />

a.s.<br />

28/11/2000 5 years<br />

8/12/2000 31/12/2004<br />

2/03/2001 5 years<br />

19/01/2001 5 years<br />

CZ 39 2002 Investiční pobídka pro společnost SETUZA, a.s. 8/02/2001 5 years<br />

CZ 40 2002 Investiční pobídka pro společnost LOGIT, s.r.o. 15/01/2001 5 years<br />

CZ 41 2002 Investiční pobídka pro společnost Ingersoll Rand<br />

European Holding Company B.V. - Torrington<br />

Česká republika s.r.o.<br />

19/02/2001 10 years<br />

CZ 42 2002 Investiční pobídka pro společnost Vitrablok, a.s. 22/02/2001 5 years<br />

CZ 43 2002 Investiční pobídka pro společnost Splintex Czech<br />

a.s.<br />

CZ 44 2002 Investiční pobídka pro společnost Valeo vy´ měníky<br />

tepla s.r.o.<br />

CZ 45 2002 Investiční pobídka pro společnost Matsushita<br />

Communication Industrial Czech, s.r.o.<br />

CZ 46 2002 Investiční pobídka pro společnost KOSTAL ČR,<br />

spol. s.r.o.<br />

12/03/2001 5 years<br />

20/03/2001 5 years<br />

28/03/2001 10 years<br />

12/03/2001 5 years<br />

CZ 47 2002 Investiční pobídka pro společnost KARSIT, s.r.o. 26/02/2001 10 years<br />

CZ 48 2002 Investiční pobídka pro společnost MAFRA, a.s. 5/04/2001 5 years


EN<br />

4 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

CZ 49 2002 Investiční pobídka pro společnost IBM World<br />

Trade Corporation<br />

CZ 50 2002 Investiční pobídka pro společnost DURA<br />

Automotive Handels — und Beteiligungs - Dura<br />

Automotive Systems CZ, s.r.o.<br />

CZ 51 2002 Investiční pobídka pro společnost Toyota Gosei<br />

Co., Ltd. a TOYOTA TSUSHO CORPORATION -<br />

TG Safety Systems Czech, s.r.o.<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

26/02/2001 10 years<br />

10/04/2001 10 years<br />

14/03/2001 10 years<br />

CZ 52 2002 Investiční pobídka pro společnost VELVETA a.s. 29/03/2001 5 years<br />

CZ 53 2002 Investiční pobídka pro společnost Holzwerke<br />

Wimmer GmbH.<br />

CZ 54 2002 Investiční pobídka pro společnost BOSCH<br />

DIESEL s.r.o.<br />

CZ 55 2002 Investiční pobídka pro společnost SENIOR<br />

INVESTMENTS AG. - Senior Automotive Czech<br />

s.r.o.<br />

CZ 57 2002 Investiční pobídka pro společnost INDET<br />

SAFETY SYSTEMS a.s.<br />

CZ 59 2002 Investiční pobídka pro společnost Kimberly-Clark,<br />

a.s.<br />

CZ 60 2002 Investiční pobídka pro společnost FUJIKOKI<br />

CORPORATION<br />

CZ 64 2002 Investiční pobídka pro společnost Jihlavské sklárny<br />

BOHEMIA, a.s.<br />

27/03/2001 10 years<br />

10/04/2001 5 years<br />

12/04/2001 10 years<br />

23/04/2001 5 years<br />

13/04/2001 5 years<br />

15/03/2001 10 years<br />

14/05/2001 5 years<br />

CZ 67 2002 Investiční pobídka pro společnost REUS s.r.o. 22/11/2001 5 years<br />

CZ 68 2002 Investiční pobídka pro společnost Mubea — HZP<br />

s.r.o.<br />

CZ 69 2002 Investiční pobídka pro společnost Osram Bruntál<br />

spol. s.r.o.<br />

CZ 70 2002 Investiční pobídka pro společnost<br />

CEBALSOL, s.r.o.<br />

CZ 71 2002 Investiční pobídka pro společnost Air Products<br />

s.r.o.<br />

CZ 72 2002 Investiční pobídka pro společnost Federal-Mogul<br />

Friction Products a.s.<br />

CZ 73 2002 Investiční pobídka pro společnost Schwan-Stabilo<br />

Cosmetics GmbH Co. - Schwan - STABILO<br />

Cosmetics, s.r.o.<br />

CZ 74 2002 Investiční pobídka pro společnost SAI Automotive<br />

Bohemia s.r.o.<br />

3/07/2001 5 years<br />

4/06/2001 5 years<br />

15/05/2001 10 years<br />

27/07/2001 5 years<br />

5/06/2001 5 years<br />

29/06/2001 10 years<br />

2/07/2001 5 years<br />

CZ 75 2002 Investiční pobídka pro společnost EPCOS s.r.o. 13/08/2001 5 years


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 5<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

CZ 76 2002 Investiční pobídka pro společnost JUTA a.s. 26/07/2001 5 years<br />

CZ 77 2002 Investiční pobídka pro společnost RUSA Rohde &<br />

Schwarz Anlagen GmbH. - ROHDE &<br />

SCHWARZ závod Vimperk, s.r.o.<br />

CZ 78 2002 Investiční pobídka pro společnost MEYSTER<br />

S.p.A.<br />

CZ 79 2002 Investiční pobídka pro společnost Wiegel Velké<br />

Mezirˇíčí zˇárové zinkování s.r.o.<br />

CZ 81 2002 Investiční pobídka pro společnost PULS investiční<br />

s.r.o.<br />

13/08/2001 10 years<br />

3/08/2001 10 years<br />

3/10/2001 10 years<br />

23/10/2001 10 years<br />

CZ 82 2002 Investiční pobídka pro společnost Rubena a.s. 10/07/2001 5 years<br />

CZ 83 2002 Investiční pobídka pro společnost KAUČUK, a.s. 23/11/2001 5 years<br />

CZ 84 2002 Investiční pobídka pro společnost ZPD Hodonín<br />

a.s.<br />

CZ 85 2002 Investiční pobídka pro společnost DENSO<br />

Corporation - DENSO MANUFACTURING<br />

CZECH s.r.o.<br />

CZ 87 2002 Investiční pobídka pro společnost MITSUBISHI<br />

ELECTRIC AUTOMOTIVE CZECH s.r.o.<br />

CZ 88 2002 Investiční pobídka pro společnost Accenture<br />

Services, s.r.o.<br />

CZ 89 2002 Investiční pobídka pro společnost F.X.MEILLER,<br />

s.r.o.<br />

CZ 90 2002 Investiční pobídka pro společnost Czech<br />

KLINIPRO, s.r.o.<br />

20/08/2001 5 years<br />

25/10/2001 10 years<br />

3/10/2001 10 years<br />

14/08/2001 10 years<br />

3/10/2001 5 years<br />

20/12/2001 10 years<br />

CZ 91 2002 Investiční pobídka pro společnost Sandvik, a.s. 13/12/2001 5 years<br />

CZ 92 2002 Investiční pobídka pro společnost UNILEVER ČR,<br />

spol. s r.o.<br />

CZ 93 2002 Investiční pobídka pro společnost Siemens —<br />

Společnost kolejovy´ ch<br />

vozidel, s.r.o.<br />

CZ 94 2002 Investiční pobídka pro společnost Visteon-<br />

Nichirin-Czech, s.r.o.<br />

CZ 95 2002 Investiční pobídka pro společnost HK Konstrukce<br />

s.r.o.<br />

CZ 96 2002 Investiční pobídka pro společnost Carlo Platt<br />

Nederland B.V. - CTP Czech<br />

Republic s.r.o.<br />

CZ 97 2002 Investiční pobídka pro společnost Zlín Precision<br />

s.r.o.<br />

CZ 98 2002 Investiční pobídka pro společnost Hartmann-Rico,<br />

a.s.<br />

5/09/2001 5 years<br />

22/10/2001 5 years<br />

1/11/2001 10 years<br />

5/02/2002 5 years<br />

23/11/2001 10 years<br />

29/01/2002 10 years<br />

23/11/2001 5 years


EN<br />

6 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

CZ 99 2002 Investiční pobídka pro společnost IRRC<br />

Manufacturing s.r.o.<br />

CZ 100 2002 Investiční pobídka pro společnost LINDE<br />

TECHNOPLYN a.s.<br />

CZ 101 2002 Investiční pobídka pro společnost Nejdecká<br />

česárna vlny a.s.<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

23/11/2001 10 years<br />

30/11/2001 5 years<br />

4/12/2001 5 years<br />

CZ 102 2002 Investiční pobídka pro společnost FIC CZ s.r.o. 13/12/2001 5 years<br />

CZ 103 2002 Investiční pobídka pro společnost Veba, textilní<br />

závody, a.s.<br />

CZ 104 2002 Investiční pobídka pro společnost RECTICEL<br />

Interiors CZ s.r.o.<br />

CZ 105 2002 Investiční pobídka pro společnost Automotive<br />

Lighting s.r.o.<br />

CZ 106 2002 Investiční pobídka pro společnost ELECTRIC<br />

POWERSTEERING COMPONENTS EUROPE<br />

S.R.O.<br />

28/01/2002 5 years<br />

10/01/2002 10 years<br />

1/02/2002 5 years<br />

28/03/2002 10 years<br />

CZ 107 2002 Investiční pobídka pro společnost Invos, spol. s.r.o. 20/02/2002 5 years<br />

CZ 108 2002 Investiční pobídka pro společnost HP - Pelzer k.s. 18/03/2002 5 years<br />

CZ 109 2002 Investiční pobídka pro společnost Tokai Rika Co.,<br />

Ltd. (TRCZ S.R.O.)<br />

CZ 110 2002 Investiční pobídka pro společnost TOS Varnsdorf<br />

a.s.<br />

CZ 111 2002 Investiční pobídka pro společnost Donaldson Torit<br />

BV<br />

CZ 112 2002 Investiční pobídka pro společnost TI Automotive<br />

Holdings Limited<br />

1/04/2002 10 years<br />

8/03/2002 5 years<br />

20/05/2002 10 years<br />

11/03/2002 10 years<br />

CZ 113 2002 Investiční pobídka pro společnost Rieter CZ, a.s. 4/04/2002 5 years<br />

CZ 115 2002 Investiční pobídka pro společnosti Schwarzmuller<br />

u. Co. Gesellschaft m.b.H. and Schwarzmuller<br />

Leasing u. Beteiligungs GmbH.<br />

CZ 116 2002 Investiční podpora vy´ stavby pro společnou vy´ robu<br />

elektrické energie z biomasy a bioplynu<br />

CZ 117 2002 Investiční pobídka pro společnosti Frantschach<br />

Pulp and Paper Czech a.s.<br />

CZ 118 2002 Investiční pobídka pro společnost IRCR<br />

Manufacturing s.r.o.<br />

CZ 119 2002 Investiční pobídka pro společnost pana Horsta<br />

Burbully (ORION TELESCOPIC<br />

CAMERACRANE SPOL. S R.O.)<br />

CZ 120 2002 Investiční pobídka pro společnost Trafil Czech,<br />

s.r.o.<br />

22/04/2002 10 years<br />

22/04/2002 —<br />

10/05/2002 5 years<br />

15/08/2002 10 years<br />

15/05/2002 10 years<br />

16/05/2002 10 years


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 7<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

CZ 121 2002 Investiční pobídka pro společnost Zexel Valeo<br />

Compressor Czech, s.r.o.<br />

CZ 122 2002 Investiční pobídka pro společnost Takada<br />

Industries Corporation<br />

CZ 123 2002 Investiční pobídka pro společnost Aoyama<br />

Seisakusho Co., Ltd.<br />

CZ 124 2002 Intenzifikace čistírny odpadních vod - AKTIVA,<br />

a.s.<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

28/06/2002 10 years<br />

3/06/2002 10 years<br />

17/06/2002 10 years<br />

27/05/2002 31/12/2005<br />

CZ 127 2002 Investiční pobídka pro společnost PEGAS a.s. 7/06/2002 10 years<br />

CZ 128 2002 Investiční pobídka pro společnost Ideal<br />

Automotive Bor, s.r.o.<br />

4/07/2002 5 years<br />

CZ 129 2002 Investiční pobídka pro společnost GEYER AG. 5/08/2002 10 years<br />

CZ 130 2002 Investiční pobídka pro společnost Fehrer Bohemia<br />

s.r.o.<br />

CZ 131 2002 Investiční pobídka pro společnost WALMARK,<br />

a.s.<br />

CZ 132 2002 Investiční pobídka pro společnost CZECH<br />

PLASTIC PRODUCTION, s.r.o.<br />

CZ 134 2002 Investiční pobídka pro společnost Blades<br />

Technology International, Inc.<br />

CZ 135 2002 Investiční pobídka pro společnost Saint-Gobain<br />

Vertex, a.s.<br />

CZ 136 2002 Investiční pobídka pro společnost První Elektro,<br />

a.s.<br />

CZ 137 2002 Investiční pobídka pro společnost IVG Colbachini<br />

S.p.A.<br />

CZ 138 2002 Investiční pobídka pro společnost Cookson<br />

Overseas Limited (VESUVIUS SOLAR<br />

CRUCIBLE, S.R.O.)<br />

6/08/2002 5 years<br />

10/07/2002 5 years<br />

19/08/2002 5 years<br />

11/09/2002 10 years<br />

3/09/2002 10 years<br />

29/08/2002 5 years<br />

8/08/2002 10 years<br />

23/08/2002 10 years<br />

CZ 165 2002 Investiční pobídka pro společnost Škoda Auto, a.s. 1/07/1999 3 years<br />

EE 1 2002 EESTI TEHNOLOOGIAAGENTUURI<br />

PROGRAMM “RAKENDUSUURINGUTE JA<br />

TOOTEARENDUSPROJEKTIDE<br />

FINANTSEERIMINE”<br />

EE 2 2002 KREDIIDI JA EKSPORDI GARANTEERIMISE<br />

SIHTASUTUSE KREDEX<br />

ETTEVÕTLUSLAENUDE GARANTEERIMISE<br />

PROGRAMM<br />

12/04/2001 31/12/2004<br />

27/06/2001 31/12/2004


EN<br />

8 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

EE 3 2002 EESTI FILMI SIHTASUTUSE PROGRAMM<br />

“EESTI RAHVUSLIKU FILMIKULTUURI<br />

ARENGU SOODUSTAMINE JA TOETAMINE”<br />

CY 1 2002 Αρχή Ανάπτυξης Ανθρωπίνου ∆υναµικού —<br />

Σχέδιο συµβουλευτικών υπηρεσιών για<br />

µικροµεσαίες επιχειρήσεις<br />

CY 2 2002 Κρατική Χορηγία προς το Θεατρικό Οργανισµό<br />

Κύπρου<br />

CY 3 2002 Αρχή Ανάπτυξης Ανθρωπίνου ∆υναµικού —<br />

Ευρωπαϊκό Πρόγραµµα Ανάπτυξης Επιχειρήσεων<br />

(ΕΠΑΕ)<br />

CY 4 2002 'Ιδρυµα Προώθησης 'Ερευνας — Πέµπτο<br />

πρόγραµµα επιχορήγησης ερευνητικών σχεδίων<br />

CY 5 2002 'Ιδρυµα Προώθησης 'Ερευνας — Πρόγραµµα<br />

ενίσχυσης νέων ερευνητών Κύπρου — ΠΕΝΕΚ<br />

2002<br />

CY 6 2002 Αρχή Ανάπτυξης Ανθρωπίνου ∆υναµικού — Σχέδιο<br />

καταβολής χορηγηµάτων για συµµετοχή στο<br />

µεταπτυχιακό πρόγραµµα του Mediterranean<br />

Institute of Management (MIM)<br />

CY 7 2002 Αρχή Ανάπτυξης Ανθρωπίνου ∆υναµικού —<br />

Πολυεπιχειρησιακά προγράµµατα συνεχιζόµενης<br />

κατάρτισης στο εξωτερικό<br />

CY 8 2002 Αρχή Ανάπτυξης Ανθρωπίνου ∆υναµικού —<br />

Πολυεπιχειρησιακά προγράµµατα συνεχιζόµενης<br />

κατάρτισης — Συνήθη<br />

CY 9 2002 Αρχή Ανάπτυξης Ανθρωπίνου ∆υναµικού —<br />

Πολυεπιχειρησιακά προγράµµατα συνεχιζόµενης<br />

κατάρτισης ζωτικής σηµασίας<br />

CY 10 2002 Αρχή Ανάπτυξης Ανθρωπίνου ∆υναµικού —<br />

Πολυεπιχειρησιακά προγράµµατα αρχικής<br />

κατάρτισης —Tαχύρυθµα<br />

CY 11 2002 Αρχή Ανάπτυξης Ανθρωπίνου ∆υναµικού —<br />

Μονοεπιχειρησιακά προγράµµατα συνεχιζόµενης<br />

κατάρτισης στο εξωτερικό<br />

CY 12 2002 Αρχή Ανάπτυξης Ανθρωπίνου ∆υναµικού —<br />

Μονοεπιχειρησιακά προγράµµατα συνεχιζόµενης<br />

κατάρτισης — Συνήθη<br />

CY 13 2002 Αρχή Ανάπτυξης Ανθρωπίνου ∆υναµικού —<br />

Μονοεπιχειρησιακά προγράµµατα αρχικής<br />

κατάρτισης — Συνήθη<br />

CY 14 2002 Αρχή Ανάπτυξης Ανθρωπίνου ∆υναµικού — Σχέδιο<br />

Στελέχωσης Επιχειρήσεων µέσα από την<br />

Αξιοποίηση Αποφοίτων Σχολών Τριτοβάθµιας<br />

Εκπαίδευσης<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

12/04/2002 31/12/2007<br />

6/06/2002 30/06/2007<br />

15/02/2002 —<br />

30/07/2002 30/06/2007<br />

9/01/2002 30/06/2004<br />

3/06/2002 31/12/2004<br />

30/07/2002 30/06/2007<br />

30/07/2002 30/06/2007<br />

30/07/2002 30/06/2007<br />

30/07/2002 30/06/2007<br />

30/07/2002 30/06/2007<br />

30/07/2002 30/06/2007<br />

30/07/2002 30/06/2007<br />

30/07/2002 30/06/2007<br />

30/07/2002 30/06/2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 9<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

CY 15 2002 Πρόγραµµα µετακίνησης µικρών επιχειρήσεων σε<br />

εγκεκριµένες περιοχές<br />

CY 16 2002 Σχέδιο παροχής κυβερνητικών χορηγιών για<br />

τεχνολογική αναβάθµιση των Μικρών και<br />

Μεσαίων Επιχειρήσεων του µεταποιητικού τοµέα<br />

CY 17 2002 Πρόγραµµα δηµιουργίας και λειτουργίας<br />

εκκολαπτηρίων επιχειρήσεων<br />

CY 18 2002 Πρόγραµµα δηµιουργίας νέων επιχειρήσεων<br />

υψηλής τεχνολογίας και καινοτοµίας µέσω των<br />

εκκολαπτηρίων επιχειρήσεων<br />

CY 19 2002 Σχέδιο παροχής οικονοµικής βοήθειας σε<br />

επιχειρήσεις/βιοµηχανίες κυπριακών προϊόντων<br />

οι οποίες συµµετέχουν µε δικά τους έξοδα σε<br />

εκθέσεις του εξωτερικού<br />

CY 20 2002 Σχέδιο παροχής οικονοµικής βοήθειας σε<br />

επιχειρήσεις/βιοµηχανίες κυπριακών προϊόντων<br />

οι οποίες συµµετέχουν σε εµπορικές εκθέσεις του<br />

εξωτερικού που οργανώνει το Υπουργείο<br />

Εµπορίου, Βιοµηχανίας και Τουρισµού<br />

CY 21 2002 'Ιδρυµα Προώθησης 'Ερευνας — Πρόγραµµα<br />

έγκρισης έργων «EUREKA ΚΥΠΡΟΥ»<br />

CY 22 2002 Σχέδιο χορηγιών για µελέτες συγχωνεύσεων -<br />

κοινοπραξιών - υπεργολαβιών στο µεταποιητικό<br />

τοµέα<br />

CY 23 2002 Μέτρα και κίνητρα για επενδύσεις σε παρεµφερή<br />

τουριστικά έργα<br />

CY 24 2002 Σχέδιο επιδότησης µελετών για διείσδυση<br />

επιχειρήσεων σε ξένες αγορές<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

9/10/2001 30/06/2007<br />

17/10/2001 30/06/2007<br />

31/10/2001 31/10/2005<br />

31/10/2001 31/10/2005<br />

8/07/2002 30/06/2007<br />

8/07/2002 30/06/2007<br />

23/08/2002 31/12/2005<br />

9/09/2002 30/06/2007<br />

9/10/2001 30/06/2007<br />

19/12/2001 30/06/2007<br />

CY 25 2002 Σχέδιο αξιοποίησης του διεθνούς διαδικτύου 19/12/2001 30/06/2007<br />

CY 26 2002 Σύστηµα HACCP για τρόφιµα και ποτά 9/01/2002 30/06/2007<br />

CY 27 2002 Σχέδιο Συµβουλευτικών Υπηρεσιών για τη<br />

Βιοµηχανία<br />

12/02/2002 30/06/2007<br />

CY 28 2002 Σχέδιο υιοθέτησης προτύπων 5/03/2002 30/06/2007<br />

CY 29 2002 Σχέδιο επιδότησης εξειδικευµένου λογισµικού 19/03/2002 30/06/2007<br />

CY 30 2002 Σχέδιο παροχής οικονοµικής βοήθειας σε<br />

επιχειρήσεις/βιοµηχανίες κυπριακών προϊόντων<br />

και υπηρεσιών οι οποίες συµµετέχουν σε<br />

εµπορικές αποστολές στο εξωτερικό που<br />

οργανώνει το Υπουργείο Εµπορίου, Βιοµηχανίας<br />

και Τουρισµού<br />

23/08/2002 30/06/2007


EN<br />

10 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

CY 31 2002 Σχέδιο παροχής οικονοµικής βοήθειας σε<br />

επιχειρήσεις/βιοµηχανίες κυπριακών προϊόντων<br />

και υπηρεσιών οι οποίες συµµετέχουν σε<br />

«Εβδοµάδα Κύπρου» στο εξωτερικό που οργανώνει<br />

το Υπουργείο Εµπορίου, Βιοµηχανίας και<br />

Τουρισµού<br />

LV 1 2002 MAZO UN VIDĒJO UZŅĒMĒJU ATTĪSTĪBAS<br />

KREDITĒŠANA<br />

LV 2 2002 Valsts atbalsta sniegšanas kārtība Latvijas<br />

uzņēmumiem dalībai starptautiskās izstādēs un<br />

gadatirgos (tirdzniecības misijās)<br />

LV 3 2002 Valsts atbalsta sniegšanas kārtība Latvijas<br />

uzņēmumiem vienreizējam ārējā tirgus pētījumam<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

23/08/2002 30/06/2007<br />

20/07/2001 31/12/2010<br />

1/11/2001 31/12/2007<br />

1/11/2001 31/12/2007<br />

LV 4 2002 A/s “Latvijas Finieris” 21/11/2001 2004-2006<br />

LV 5 2002 A/s “Latvijas Unibanka” 31/01/2002 2005-2007<br />

LV 6 2002 SIA “LatRosTrans” 17/07/2002 2005-2008<br />

LT 1 2002 Investicijos i˛ Klaipe˙dos laisva˛ja˛ ekonomine˛ zona˛ 1/02/2001 28/02/2009<br />

LT 2 2002 Dalinis draudimo i˛moku˛ moke˙jimas eksporto<br />

kredito srityje<br />

18/12/2000 —<br />

LT 3 2002 Inovaciju˛ versle programa 4/10/2001 —<br />

HU 1 2002 Területfejlesztési célelőirányzat 24/01/2002 31/12/2006<br />

HU 2 2002 Vidékfejlesztési célelőirányzat 26/03/2002 31/12/2006<br />

HU 10 2002 A Beszállítói Befektető Rt. tevékenysége 7/11/2001 —<br />

HU 11 2002 Munkahelyteremtő és munkahelymegőrző<br />

támogatás a foglalkoztatást elősegítő<br />

támogatásokról, valamint a Munkaerőpiaci Alapból<br />

foglalkoztatási válsághelyzetek kezelésére<br />

nyújtható támogatásokról szóló 6/1996. (VII. 16.)<br />

MüM rendelet alapján<br />

29/11/2001 31/12/2006<br />

HU 12 2002 Vértesi Erőmű Rt. 6/03/2002 from 2001 until<br />

2014<br />

HU 14 2002 Sporttevékenységgel kapcsolatos állami<br />

támogatások<br />

HU 16 2002 A Kisvállalkozás-fejlesztő Pénzügyi Rt. által<br />

végzett kockázati tőkebefektetések<br />

HU 17 2002 A pályakezdő munkanélküliek elhelyezkedésének<br />

támogatása<br />

HU 18 2002 Megváltozott munkaképességűek foglalkoztatási<br />

támogatása a munkaügyi központok foglalkoztatási<br />

rehabilitációs eljárásáról, valamint a megváltozott<br />

munkaképességű munkanélküliek foglalkoztatását<br />

elősegítő egyes támogatásokról szóló 11/1998.<br />

(IV.19.) MüM rendelet alapján<br />

3/10/2002 31/12/2006<br />

24/07/2002 —<br />

2/10/2002 31/12/2006<br />

2/10/2002 31/12/2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 11<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

HU 20 2002 Nemzeti Kutatási és Fejlesztési Programok 3/10/2002 31/12/2006<br />

HU 21 2002 A Regionális Fejlesztési Holding Rt és fejlesztési<br />

társaságainak kockázati tőke befektetései<br />

HU 22 2002 Az Informatikai Kockázati Tőkealap kockázati<br />

tőkebefektetései<br />

HU 24 2002 Informatikai, távközlés-fejlesztési és<br />

frekvenciagazdálkodási célelőirányzat<br />

HU 26 2002 85/1998. korm. rendelet a Magyar Export-import<br />

Bank kamatkiegyenlítési rendszeréről<br />

4/10/2002 —<br />

4/10/2002 —<br />

18/10/2002 31/12/2006<br />

17/10/2002 31/12/2006<br />

HU 27 2002 Gazdaságépítési célelőirányzat 17/10/2002 31/12/2006<br />

HU 28 2002 Kis- és középvállalkozói célelőirányzat 17/10/2002 31/12/2006<br />

HU 29 2002 Regionális Gazdaságépítési célelőirányzat 17/10/2002 31/12/2006<br />

HU 30 2002 Turisztikai célelőirányzat 18/10/2002 31/12/2006<br />

HU 31 2002 Környezetvédelmi alap célfeladat fejezeti kezelésű<br />

célelőirányzat<br />

6/12/2001 31/12/2006<br />

HU 32 2002 Központi Műszaki Fejlesztési Alapprogram 3/10/2002 31/12/2006<br />

HU 33 2002 Fejlesztési adókedvezmény 18/10/2002 31/12/2006<br />

MT 1 2002 Intrapriz˙i z˙gh - ar u ta' daqs medju (Regolament 11<br />

tar-Regolamenti ta' l-2001 dwar il-Promozzjoni<br />

tan-Negozju)<br />

MT 2 2002 Assistenza gh - at-tah - rig˙ (Regolament 14 tar-<br />

Regolamenti ta' l-2001 dwar il-Promozzjoni tan-<br />

Negozju)<br />

MT 4 2002 Krediti ta' taxxa fuq l-investiment (Regolament 5<br />

tar-Regolamenti ta' l-2001 dwar il-Promozzjoni<br />

tan-Negozju)<br />

MT 6 2002 Soft loans (Regolament 8 tar-Regolamenti ta' l-<br />

2001 dwar il-Promozzjoni tan-Negozju)<br />

MT 7 2002 Sussidji fuq imgh - ax fuq self (Regolament 9 tar-<br />

Regolamenti ta' l-2001 dwar il-Promozzjoni tan-<br />

Negozju)<br />

MT 8 2002 Garanziji fuq self (Regolament 10 tar-Regolamenti<br />

ta' l-2001 dwar il-Promozzjoni tan-Negozju)<br />

19/07/2001 —<br />

19/07/2001 —<br />

19/07/2001 —<br />

19/07/2001 —<br />

19/07/2001 —<br />

19/07/2001 —<br />

MT 9 2002 Sussidju gh - all-Kultura. 6/04/2001 —


EN<br />

12 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

PL 4 2002 Warunki udzielania pomocy w specjalnych strefach<br />

ekonomicznych<br />

(Ustawa o specjalnych strefach ekonomicznych<br />

oraz Rozporza˛dzenia Rady Ministrów w sprawie<br />

ustanowienia: Tarnobrzeskiej SSE, SSE<br />

„Starachowice”, SSE w Krakowie, Wałbrzyskiej<br />

SSE, Warmińsko-Mazurskiej SSE, SSE w Mielcu,<br />

SSE w Kamiennej Górze, Legnickiej SSE,<br />

Słupskiej SSE, Kostrzyńsko-Słubickiej SSE,<br />

Pomorskiej SSE, Łódzkiej SSE, Katowickiej SSE,<br />

Suwalskiej SSE)<br />

PL 6 2002 Kryteria i tryb przyznawania i rozliczania s´rodków<br />

finansowych ustalanych w budz˙ecie państwa na<br />

nauke˛<br />

PL 13 2002 Program pomocy regionalnej dla przedsie˛biorców<br />

prowadza˛cych działalnos´ć gospodarcza˛ w<br />

specjalnych strefach ekonomicznych<br />

PL 20 2002 Refundacja wynagrodzeń wypłacanych<br />

młodocianym pracownikom<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

8/08/2001 31/12/2017<br />

20/12/2001 —<br />

14/10/2002 until end of 2017<br />

14/10/2002 —<br />

PL 24 2002 Szkolenia pracowników 14/10/2002 —<br />

PL 41 2002 Stabilne zatrudnienie 14/10/2002 —<br />

PL 44 2002 Program pomocy publicznej dla przedsie˛biorców<br />

zatrudniaja˛cych osoby pozbawione wolnos´ci<br />

SI 1 2002 Program ekološke sanacije rudarskih objektov in<br />

naprav za pridobivanje ogljikovodikov v Republiki<br />

Sloveniji<br />

SI 3 2002 Program postopnega zapiranja rudnika Trbovlje<br />

Hrastnik<br />

SI 4 2002 Dodelitev drzˇavne pomoči subjektom v<br />

ekonomskih conah<br />

14/10/2002 —<br />

1/03/2000 1/03/2010<br />

7/10/2002 31/12/2004<br />

7/02/2002 31/12/2009<br />

SI 5 2002 Sofinanciranje okoljskih nalozˇb 29/11/2001 31/12/2008<br />

SI 6 2002 Garancija Republike Slovenije za Termoelektrarno<br />

Šoštanj, za najetje kredita za ekološko sanacijo<br />

TEŠ - razzˇveplalne<br />

SI 7 2002 Program ukrepov za spodbujanja podjetništva in<br />

konkurenčnosti za obdobje 2002-2006<br />

SI 8 2002 Program izvedbe trajne opustitve izkoriščanja<br />

uranove rude in preprečevanja posledic rudarjenja<br />

v Rudniku urana Zˇirovski vrh<br />

SI 10 2002 Sofinanciranje projektov iz proračunskega sklada<br />

za avdiovizualne medije<br />

SI 11 2002 Sofinanciranje ustvarjanja programskih vsebin in<br />

razvoja tehnične infrastrukture na področju<br />

medijev<br />

SI 12 2002 Program razvojnega prestrukturiranja Zasavske<br />

regije<br />

21/06/2000 21/06/2012<br />

22/07/2002 31/12/2006<br />

22/04/2002 31/12/2005<br />

27/05/2002 31/12/2004<br />

27/05/2002 31/12/2004<br />

11/06/2002 31/12/2004


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 13<br />

No.<br />

MS Nr Yr<br />

Title (original)<br />

SI 13 2002 Program spodbujanja razvoja v Posočju 2002-2006<br />

(Soca 2006)<br />

SI 14 2002 Kreditna shema za financiranje investicij v mikro<br />

in majhnih podjetjih ter pri podjetnikih<br />

posameznikih<br />

SI 15 2002 Dodeljevanje pomoči gospodarskim druzˇbam v<br />

času priprav programa<br />

prestrukturiranja iz sredstev<br />

kupnin za namene sanacije<br />

SI 16 2002 Prenova in razvoj ATC Kanin Bovec d.o.o. -<br />

program investicij v obdobju od leta 2002 do leta<br />

2004<br />

Date of approval by national<br />

State aid monitoring<br />

authority<br />

Duration<br />

11/06/2002 31/12/2006<br />

11/06/2002 31/12/2008<br />

11/06/2002 31/12/2004<br />

10/09/2002 31/12/2004<br />

SI 18 2002 Regionalna shema 7/10/2002 21/12/2006<br />

SK 1 2002 VUB Bratislava 20/12/2001 31/12/2008<br />

SK 2 2002 SES Tlmače 19/04/2002 31/12/2005<br />

SK 3 2002 Embraco Slovakia 10/07/2002 31/12/2010<br />

SK 4 2002 Ecco Slovakia 15/07/2002 31/12/2010<br />

SK 5 2002 Edscha Slovakia 11/07/2002 31/12/2010<br />

SK 6 2002 SACHS Slovakia 5/07/2002 31/12/2010<br />

SK 7 2002 SEWS Slovakia 15/07/2002 31/12/2010<br />

SK 8 2002 Holcim (Slovensko) 6/08/2002 31/12/2012<br />

SK 9 2002 Bloomsbury Pacific Slovakia 20/08/2002 31/12/2012


EN<br />

14 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Appendix A<br />

referred to in Chapter 3, Section A, point 1 of Annex V (*)<br />

List of establishments, including shortcomings and deadlines for the correction of these shortcomings<br />

SLAUGHTERHOUSES<br />

No Vet. No Name of establishment Shortcomings<br />

1 BEKKVA s.r.o. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a) and (b)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 11<br />

2 Druzˇstevní jatka Sádek, druzˇstvo Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (e) and (f)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5 and 11Annex I,<br />

Chapter II, point 14(a), (b) and (h)<br />

Annex I, Chapter III, point 15<br />

3 JABOR, s.r.o. Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 9<br />

Annex II, Chapter II, point 10(b), (c) and (e)<br />

4 Jirˇí Papst, Jatka Oudoleň Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d),<br />

and (g)<br />

Annex I, Chapter I, points 5, 6 and 11<br />

Annex I, Chapter II, point 14(b), (f) and (j)<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

5 Jatka Svitavy, spol. s r.o. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), and (g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter II, point 14(e) and (f)<br />

6 Jaroslav Kouba, Rˇeznictví — uzenárˇství<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(b), (c) and (e)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 4(c) and (d)<br />

Annex I, Chapter I, points 5, 11 and 12<br />

Annex I, Chapter II, point 14(b), (e), (h) and<br />

(i),<br />

Annex I, Chapter III, point 15(b)<br />

7 Vladimír Zezula, Jatky Rudíkov Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (e) and (f)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a)<br />

Annex I, Chapter I, points 5 and 11<br />

Annex I, Chapter II, point 14(h)<br />

Annex I, Chapter IV, point 16(b)<br />

8 MABROS, s.r.o. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(b) and (c)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11 and 12<br />

Annex I, Chapter II, point 14(h)<br />

(*) For the text of Annex V see OJ L 236, 23.9.2003, p. 803.<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2005<br />

31.12.2004<br />

31.12.2006<br />

30.6.2006<br />

31.12.2005<br />

31.12.2006<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 15<br />

No Vet. No Name of establishment Shortcomings<br />

9 Karel Nozar, Jatky Janov Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a) and (b)<br />

Annex I, Chapter I, points 2(a) and 11<br />

10 Václav Raus, Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a) and (b)<br />

Annex I, Chapter I, point 5<br />

Annex I, Chapter II, point 14(a)<br />

11 Pavel Hrˇebejk — firma Slávie Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b) and (e)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11 and 12<br />

Annex I, Chapter II, point 14(a), (b), (c) and<br />

(h)<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b) and (e)<br />

Annex B, Chapter I, point 1(b), (d), (e) and (f)<br />

12 VAVRAS, spol. s r.o. Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(b) and (e)<br />

13 Vlama, spol. s r. o. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a) and (b)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter II, point 14(e) and (g)<br />

14 Zemědělské druzˇstvo Čechtice —<br />

Jatka Jeníkov<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c) and (d)<br />

Annex I, Chapter I, point 4(d)<br />

Annex I, Chapter I, points 5 and 11<br />

15 ZDV jatky Charvatce Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b) and (e)<br />

Annex I, Chapter I, points 11 and 12<br />

Annex I, Chapter II, point 14(b) and (c)<br />

Council Directive 77/99/EEC:<br />

Annex B, Chapter I, point 1(d)<br />

16 ZD Rosice u Chrasti — masná<br />

vy´ roba a jatky<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e) and<br />

(g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5 and 11<br />

17 ZD Vodňany Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(b)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11 and 12<br />

Annex I, Chapter II, point 14(a) and (b)<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2005<br />

31.12.2006<br />

31.12.2004<br />

31.12.2004<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006<br />

31.12.2005


EN<br />

16 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of establishment Shortcomings<br />

18 Jaroslav Zezula —<br />

rˇeznictví, uzenárˇství<br />

Since 1. September 2002<br />

as Jatky Zezula — Jadrny´ , s.r.o.<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f) and (g)<br />

Annex I, Chapter I, points 5, 11 and 12<br />

Annex I, Chapter II, points 14(b) and (h)<br />

19 Jatky Chotěborˇ Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), and (e),<br />

Annex I, Chapter I, points 5 and 11<br />

Annex I, Chapter II, point 14(b) and (f)<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

20 Zemědělské obchodní druzˇstvo,<br />

druzˇstvo Šebkovice<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(b), (c) and (e)<br />

Annex I, Chapter I, points 7 and 11<br />

Annex I, Chapter III, point 15(b),<br />

Annex I, Chapter IV, point 16(b)<br />

21 Ing. Václav Kozel, ZOOINFORMA Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(g)<br />

Annex I, Chapter I, point 4(a)<br />

Annex I, Chapter II, point 14(a), (b), (c), (h)<br />

and (j)<br />

22 ZVOS Hustopeče, a.s. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a) and (b)<br />

Annex I, Chapter I, point 9<br />

Annex I, Chapter II, point 14(a) and (h)<br />

Annex I, Chapter IV, point 16(a)<br />

23 MASOEKO, s.r.o., Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c) and (e)<br />

Annex I, Chapter I, point 2(a) and (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b) and (c)<br />

Annex I, Chapter I, points 5, 10, 11 and 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(f) and (h)<br />

Annex I, Chapter III, point 15(b)<br />

MEAT PROCESSING AND MANUFACTURING OF MEAT PRODUCTS<br />

No Vet. No Name of establishment Shortcomings<br />

1 Agrodruzˇstvo vlastníku˚ — ADV<br />

Libštát<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, points 5 and 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (c), (d) and (g)<br />

Annex A, Chapter I, point 4<br />

Date of full<br />

compliance<br />

31.12.2004<br />

30.06.2006<br />

31.12.2004<br />

31.12.2006<br />

31.12.2004<br />

31.12.2006<br />

Date of full<br />

compliance<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 17<br />

No Vet. No Name of establishment Shortcomings<br />

2 Bomas Brno, s.r.o. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b) and (e)<br />

Annex I, Chapter I, point 11<br />

3 Josef Kalina — JoKa Litoměrˇice Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b) and (c)<br />

Annex A, Chapter I, point 11<br />

Annex B, Chapter I, point 1(d)<br />

Annex B, Chapter II, point 4<br />

4 Masny´ pru˚mysl — Krásno, spol. s<br />

r.o.<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a) and (g)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter II, point 14(b), (h) and (j)<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a) and (c)<br />

Annex A, Chapter I, point 11<br />

5 Pejša Bohumil, rˇeznictví uzenárˇství Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c) and (g)<br />

Annex I, Chapter I, points 2(a) and (b)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter III, point 15(b)<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c) and (g)<br />

Annex A, Chapter I, point 11<br />

6 Vysočina, a.s. Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a) and (b)<br />

Annex A, Chapter I, point 11<br />

POULTRY SLAUGHTERHOUSES<br />

No Vet. No Name of establishment Shortcomings<br />

1 Melbro, a.s., porázˇka dru˚bezˇe<br />

Litoměrˇice (now as AGF Trading<br />

a.s., strˇedisko 07 Litoměrˇice)<br />

Council Directive 71/118/EEC:<br />

Annex I, Chapter I, point 1(g)<br />

Annex I, Chapter I, points 11 and 12<br />

Annex I, Chapter II, point 14(a), (b) and (c)<br />

Annex I, Chapter IV, points 16(a) and (b)<br />

Annex I, Chapter IV, point 17(a) and (b)<br />

2 DIEMA, spol. s r.o. Council Directive 71/118/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (d), (e) and<br />

(g)<br />

Annex I, Chapter I, points 9 and 12<br />

Annex I, Chapter IV, points 16 and 17<br />

3 Podkrkonošská odbytová s.r.o. Council Directive 71/118/EEC:<br />

Annex I, Chapter I, point 1(a)<br />

Annex I, Chapter I, point 5<br />

Annex I, Chapter II, point 14(b) and (c)<br />

Date of full<br />

compliance<br />

31.12.2005<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006<br />

31.12.2005<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006


EN<br />

18 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of establishment Shortcomings<br />

4 Velkopavlovické dru˚bezˇárˇské<br />

závody a.s.<br />

POULTRYMEAT PRODUCTS AND EGGS<br />

Council Directive 71/118/EEC:<br />

Annex I, Chapter I, point 1(b)<br />

Annex I, Chapter II, point 14(b), (c) and (g)<br />

Annex I, Chapter XIII, point 69<br />

No Vet. No Name of establishment Shortcomings<br />

1 Dru˚bezˇ Prˇíšovice a.s. Council Directive 71/118/EEC:<br />

Annex I, Chapter I, point 1(a), (b) and (e)<br />

Annex I, Chapter I, point 5<br />

2 Velkopavlovické dru˚bezˇárˇské<br />

závody a.s.<br />

DAIRIES<br />

Council Directive 89/437/EEC:<br />

Annex, Chapter I, point 1(a)<br />

Annex, Chapter I, point 3<br />

Annex, Chapter II, points 1, 4 and 8<br />

No Vet. No Name of establishment Shortcomings<br />

1 Krkonošské sy´ rárny a.s. Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d)<br />

and (g)<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter II.A, point 2<br />

2 Krkonošské sy´ rárny a.s. Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 2(a), (b), (c) and (g)<br />

Annex B, Chapter I, points 8 and 11<br />

3 Mlékárna Čejetičky spol. s r.o. Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 2(a), (b), (c) and (g)<br />

Annex B, Chapter I, point 3<br />

4 PROM s.r.o. Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex B, Chapter I, points 3, 9, 11, 13 and<br />

15<br />

Annex B, Chapter VI, point 1<br />

5 NET- Kralovice, spol. s r.o. Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 2(b) and (c)<br />

Annex B, Chapter I, points 3 and 14<br />

Annex B, Chapter VI, point 1<br />

6 Tavírna sy´ ru˚ Nymburk s.r.o. Council Directive 92/46/EEC:<br />

Annex B, Chapter I, points 3 and 11<br />

Date of full<br />

compliance<br />

31.12.2006<br />

Date of full<br />

compliance<br />

31.12.2005<br />

31.12.2006<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2006<br />

31.12.2005<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 19<br />

ANIMAL WELFARE<br />

No<br />

Appendix B<br />

referred to in Chapter 3, Section A, point 2 of Annex V (*)<br />

List of establishments, including capacity of non-complying cages<br />

1 Agricol s. r. o., Polička<br />

T. Novákové 521<br />

572 01 Polička<br />

Svitavy/Pardubicky´<br />

Farm: Opatovice,<br />

Velké dráhy 318,<br />

664 61 Rajhrad<br />

Brno venkov/Jihomoravsky´<br />

2 ZZN Pardubice a. s.<br />

Dělnická 384<br />

531 25 Pardubice<br />

Farm: Opatovice n. Labem,<br />

533 45 Opatovice n. L.,<br />

Pardubice/Pardubicky´<br />

3 Statek Miroslav a. s.<br />

Nádrazˇní 1<br />

671 72 Miroslav<br />

Znojmo/Jihomoravsky´<br />

Name of the establishment<br />

Area/Region<br />

4 Podnik zˇivočišné vy´ roby Novy´ Jičín a. s.<br />

Divadelní 9<br />

741 01 Novy´ Jičín<br />

Farm: Kunín,<br />

742 53 Kunín,<br />

Novy´ Jičín/Moravskoslezsky´<br />

5 VEMA a. s. Chrudim<br />

Dačická 911<br />

537 60 Chrudim<br />

Chrudim/Pardubicky´<br />

6 Dru˚bezˇárna Holešov s. r. o.<br />

Borˇenovská 1356<br />

769 01 Holešov<br />

Prˇerov/Zlínsky´<br />

7 Jaroslav Jerˇábek<br />

Újezd 12<br />

267 61 Cerhovice<br />

Beroun/Strˇedočesky´<br />

8 BIKOS s. r. o. Velká Bíteš<br />

Tišnovská 366<br />

595 01 Velká Bíteš/Zˇd’ár nad Sázavou<br />

Farm: Košíky,<br />

595 01 Velká Bíteš<br />

Zˇd’ár nad Sázavou/Vysočina<br />

9 Proagro Nymburk a. s.<br />

Poděbradská 2026<br />

288 72 Nymburk<br />

Farm: Městec<br />

Králové, Prazˇská ul.,<br />

289 03 Městec Králové<br />

Nymburk/Strˇedočesky´<br />

Capacity in laying hens<br />

(pieces)<br />

81 900 (*)<br />

50 000<br />

14 400 (*)<br />

18 000<br />

84 420<br />

26 000<br />

1 512<br />

58 864 (*)<br />

216 000 (*)<br />

(*) The slope in the cages exceeds the requirement in the Directive of 14 %. The inclusion of these cages in the transition period is<br />

therefore on the condition that this is corrected while still fulfilling the remaining height requirements as agreed with the Czech<br />

Republic.<br />

(*) For the text of Annex V see OJ L 236, 23.9.2003, p. 803.


EN<br />

20 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Appendix<br />

referred to in Chapter 1 of Annex VII (*)<br />

List as provided by Cyprus in one language of pharmaceutical products for which a marketing authorisation issued<br />

under Cypriot law prior to the date of accession shall remain valid until it is renewed in compliance with the acquis or<br />

until 31 December 2005, whichever is the earlier.<br />

Mention on this list does not prejudge whether or not the pharmaceutical product in question has a marketing<br />

authorisation in compliance with the acquis.<br />

The attached lists A and B indicate the pharmaceutical products for human use and the veterinary medicinal products<br />

respectively, which are currently in circulation in Cyprus. These products were granted their initial marketing authorisation/licence<br />

based on the old, non-harmonised legislation.<br />

The marketing authorisations of all pharmaceutical products listed, will be renewed (if requested by the manufacturers<br />

and/or importers) during 2004 and 2005 in accordance with the provisions of the new, harmonised legislation and<br />

eventually, fully harmonised dossiers will be achieved by 31 December 2005.<br />

LIST A: MEDICINAL PRODUCTS FOR HUMAN USE<br />

Code No Product<br />

9900231 4-WAY NASAL FAST ACTING SPRAY 1%<br />

9800571 5-FLUOROURACIL ‘EBEWE’ VIALS 50MG/ML, 10ML<br />

9800570 5-FLUOROURACIL ‘EBEWE’ VIALS 50MG/ML, 5ML<br />

9700037 -5-FLUOROURACIL INJECTION 50MG/ML<br />

9800572 5-FLUOROURACIL‘EBEWE’ VIALS 50MG/ML, 20ML<br />

20050619 99F0165 HAIR & NAILCARE CAPSULES<br />

97F0150 ABC SPEKTRUM TABLETS<br />

9800252 ABERNIL TABLETS 50MG<br />

9800252 ABERNIL TABLETS 50MG<br />

9800550 AB-HYOSCINE BUTYLBROMIDE INJECTION 20MG/ML<br />

9900615 ACARILBIAL LIQUID<br />

8700493 ACEPROTIN TABLETS 25MG<br />

8700492 ACEPROTIN TABLETS 50MG<br />

97F0154 ACEROLA TABLETS 500MG<br />

9700217 ACETAZOLAMIDE TABLETS 250MG<br />

9400248 ACETAZONE FORTE TABLETS<br />

9500684 ACICLOVIR GOLGI CREAM 5% W/W<br />

99F0042 ACIDOPHILUS CAPSULES 40MG<br />

9500658 ACIDRINE TABLETS<br />

8400119 ACTIFED DM COUGH LINCTUS SYRUP<br />

8200220 ACTIFED EXPECTORANT SYRUP<br />

8100193 ACTIFED TABLETS<br />

9800445 ACTIVELLE TABLETS<br />

8900382 ACTRAPID HM INJECTION 100IU/ML, 10ML VIALS<br />

9400342 ACTRAPID HM PENFILL INJECTION 100IU/ML, 3ML CARTR<br />

8900381 ACTRAPID HM PENFILL INJECTION 100IU/ML,1.5ML CARTR<br />

8500351 ACTRAPID MC INJECTION 100IU/ML, 10ML VIALS<br />

9500243 ACUITEL FILM COATED TABLETS 10MG<br />

9000392 ACUITEL FILM COATED TABLETS 20MG<br />

9000391 ACUITEL FILM COATED TABLETS 5MG<br />

(*) For the text of Annex VII see OJ L 236, 23.9.2003, p. 819.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 21<br />

Code No Product<br />

9900565 ACYCLOVIR TABLETS 200MG<br />

9900566 ACYCLOVIR TABLETS 400MG<br />

9900567 ACYCLOVIR TABLETS 800MG<br />

9900222 ADAFERIN GEL 0.1%<br />

9600391 ADALAT CC COATED TABLETS 30MG<br />

2000367 ADALAT LA TABLETS 30MG<br />

2000368 ADALAT LA TABLETS 60MG<br />

8600670 ADALAT RETARD SUSTAINED RELEASE TABLETS 20MG<br />

8400620 ADD-ACTEN TABLETS<br />

9800269 ADDITIVA CALCIUM EFFERVESCENT TABLETS 500MG<br />

9800270 ADDITIVA ETSEN (Fe2+) EFFERVESCENT TABLETS 18MG<br />

9800267 ADDITIVA MAGNESIUM EFFERVESCENT TABLETS 150MG<br />

9500062 ADDITIVA VITAMIN C BLUTORANGE EFFERVESCENT TABLETS<br />

9400204 ADENOCOR IV INJECTION 6MG/2ML<br />

9600520 ADENOSAN SHAMPOO 2%<br />

9900497 AD-MUC OINTMENT<br />

9600447 ADVANTAN CREAM 1MG<br />

9600446 ADVANTAN FATTY OINTMENT 1MG<br />

9600448 ADVANTAN OINTMENT 1MG<br />

9800554 ADVIL SUGAR COATED TABLETS 200MG<br />

9900665 AGELMIN FILM COATED TABLETS 10MG<br />

8000431 A-GEN VAGINAL SUPPOSITORIES<br />

9800604 AGGRASTAT IV CONCENTRATE FOR INFUSION 0.25MG/ML<br />

9400018 AGRIPPAL S1 INJECTION 0.5ML<br />

9600519 AIDOL ORAL SUSP. 50MG/5ML<br />

9200363 AIDOL TABLETS 500MG<br />

9200138 AIRTAL TABLETS 100MG<br />

8700541 AKAMON TABLETS 1.5MG<br />

7900048 AKINETON RETARD SUSTAINED RELEASE TABLETS 4MG<br />

7900047 AKINETON TABLETS 2MG<br />

9700548 AKNE-MYCIN EMULSION 1%<br />

9700546 AKNE-MYCIN OINTMENT 2%<br />

9700544 AKNE-MYCIN SOLUTION 2%<br />

9700553 AKNEROXID GEL 5%<br />

8400033 AKTIFERRIN-F SOFT GELATIN CAPSULES<br />

9800454 ALBUMIN HUMAN INFUSION 20%<br />

2000082 ALBUMIN HUMAN INFUSION 20%, 100ML<br />

2000081 ALBUMIN HUMAN INFUSION 20%, 50ML<br />

9900663 ALCITON NASAL SPRAY 0.02%<br />

8900771 ALDACTONE TABLETS 100MG<br />

8900778 ALDACTONE TABLETS 25MG<br />

7700404 ALDIX TABLETS 40MG<br />

9400497 ALFINOR TABLETS 8MG


EN<br />

22 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9400351 ALFOXAN SYRUP 50MG/5ML<br />

9600192 ALGAMEX CHEWABLE TABLETS 500MG<br />

9500549 ALGESALONA CREAM<br />

9500021 ALGIDOL SACHETS<br />

2000146 ALLERGODIL EYE DROPS 0.05%<br />

9400066 ALLERGODIL NASAL SPRAY 0.1% W/V<br />

9600190 ALLERGOTIN EYE DROPS 2%<br />

9600191 ALLERGOTIN EYE DROPS 4%<br />

95F0507 ALLITHERA CAPSULES 500MG<br />

8500222 ALLOPURINOL-RATIOPHARM TABLETS 300MG<br />

9400303 ALLVORAN FILM COATED TABLETS 25MG<br />

9400304 ALLVORAN FILM COATED TABLETS 50MG<br />

9400305 ALLVORAN RETARD SUSTAINED RELEASE TABLETS 100MG<br />

9400306 ALLVORAN S SUPPOSITORIES 100MG<br />

9400307 ALLVORAN SF INJECTION 75MG/3ML<br />

8400703 ALMIRAL ENTERIC COATED TABLETS 25MG<br />

8400704 ALMIRAL ENTERIC COATED TABLETS 50MG<br />

8900321 ALMIRAL GEL 1% W/W<br />

9000030 ALMIRAL INJECTION 25MG/ML, 3ML<br />

8500461 ALMIRAL SUSTAINED RELEASE TABLETS 100MG<br />

9700190 ALOMIDE EYE DROPS 0.1% W/V<br />

9900064 ALPHAGAN EYE DROPS 0.2%<br />

8500121 ALPHOSYL CREAM<br />

8500123 ALPHOSYL HC CREAM<br />

9900568 ALPRAZOLAM TABLETS 0.25MG<br />

9500538 ALPRAZOLAM TABLETS 0.5MG<br />

9900569 ALPRAZOLAM TABLETS 0.5MG<br />

9500539 ALPRAZOLAM TABLETS 1MG<br />

9900570 ALPRAZOLAM TABLETS 1MG<br />

9000272 ALTEN CREAM 0.05%<br />

9000574 ALUTRIL CHEWABLE TABLETS<br />

9300401 ALVEOFACT VIALS<br />

8400625 ALVERIX TABLETS 5MG<br />

9500657 ALVITYL SYRUP<br />

7500071 ALVOGYL PASTE<br />

9800083 AMARIN CAPSULES 15MG<br />

9800083 AMARIN CAPSULES 15MG<br />

9300372 AMARIN CAPSULES 30MG<br />

9600437 AMARYL TABLETS 1MG<br />

9600438 AMARYL TABLETS 2MG<br />

9600439 AMARYL TABLETS 3MG<br />

8700532 AMBEN POWDER FOR ORAL SUSP. 250MG/5ML<br />

8700533 AMBEN POWDER FOR ORAL SUSP. 500MG/5ML


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 23<br />

Code No Product<br />

9500046 AMBROHEXAL TABLETS 30MG<br />

8800617 AMBROXOL-RATIOPHARM SUSTAINED RELEASE CAPSULES 75MG<br />

8200373 AMEN TABLETS 100MG<br />

8600268 AMILORID COMP TABLETS<br />

8400311 AMILORIDE TABLETS 5MG<br />

9800314 AMILOZID-B TABLETS<br />

8600091 AMINOPHYLLINE SUPPOSITORIES 360MG<br />

9200111 AMINOPHYLLINE TABLETS 250MG<br />

7600433 AMINOPLASMAL L-10 PARENTERAL SOLUTION 500ML<br />

7600432 AMINOPLASMAL L-5 PARENTERAL SOLUTION 500ML<br />

9700201 AMINOSTERIL INFUSION 10%<br />

8300489 AMIODARONE TABLETS 200MG<br />

8000536 AMIROL FILM COATED TABLETS 10MG<br />

8000573 AMIROL FILM COATED TABLETS 25MG<br />

9900443 AMITRIPTYLINE HCI TABLETS 10MG<br />

9900444 AMITRIPTYLINE HCI TABLETS 25MG<br />

9900445 AMITRIPTYLINE HCI TABLETS 50MG<br />

9400453 AMODEX CAPSULES 500MG<br />

9400455 AMODEX POWDER FOR RECONSTITUTION 250MG/5ML<br />

9400456 AMODEX POWDER FOR RECONSTITUTION 500MG/5ML<br />

9100074 AMODIAQUINE FILM COATED TABLETS 200MG<br />

8100069 AMOXAPEN CAPSULES 250MG<br />

9000233 AMOXICILLIN-RATIOPHARM 250TS POWDER FOR ORAL SUSP. 250MG/5ML<br />

8900146 AMOXICILLIN-RATIOPHARM 500 FILM COATED TABLETS 500MG<br />

7201303 AMOXIL CAPSULES 250MG<br />

7201306 AMOXIL FORTE POWDER FOR ORAL SUSP. 250MG/5ML<br />

7201304 AMOXIL PAEDIATRIC DROPS 100MG/ML<br />

7700299 AMOXIL POWDER FOR INJECTION 250MG VIALS<br />

7700300 AMOXIL POWDER FOR INJECTION 500MG VIALS<br />

7201305 AMOXIL POWDER FOR ORAL SUSP. 125MG/5ML<br />

9000114 AMOXIMEX POWDER FOR ORAL SUSP. 250MG/5ML<br />

9000116 AMOXIMEX TABLETS 1000MG<br />

9000115 AMOXIMEX TABLETS 500MG<br />

9000209 AMOXY-DIOLAN POWDER FOR ORAL SUSPENSION 250MG/5ML<br />

9100186 AMPICILLIN-VOGEN CAPSULES 500MG<br />

9300414 AMPISUL CAPSULES 250MG<br />

9300415 AMPISUL CAPSULES 500MG<br />

9500534 AMYZOL CAPSULES 50MG<br />

2000188 ANABACT GEL 0.75% W/W<br />

8800463 ANADIN TABLETS 500MG<br />

9900358 ANAFRANIL INJECTION 25MG/2ML<br />

9900372 ANAFRANIL SLOW RELEASE TABLETS DIVIDABLE 75MG<br />

9900357 ANAFRANIL SUGAR COATED TABLETS 10MG


EN<br />

24 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9900356 ANAFRANIL SUGAR COATED TABLETS 25MG<br />

8500298 ANALGISER TABLETS 500MG<br />

9300396 ANAVIX SYRUP 15MG/5ML<br />

9300397 ANAVIX SYRUP 30MG/5ML<br />

8400083 ANDRIOL CAPSULES 40MG<br />

8300175 ANDROCUR TABLETS 10MG<br />

8300176 ANDROCUR TABLETS 50MG<br />

7100385 ANERVAN SUPPOSITORIES<br />

7100384 ANERVAN TABLETS<br />

9400085 ANFADOX CAPSULES 100MG<br />

9900164 ANGINOVA TABLETS<br />

2000046 ANTHISAN PLUS SPRAY<br />

9800331 ANTIBIOPTAL EYE DROPS<br />

9400290 ANTIFUNGOL CREAM 1%<br />

8900553 ANTIKINAL TABLETS 5MG<br />

2100049 ANTIPHLOGISTINE RUB A-535 CAPSAICIN GEL<br />

2100048 ANTIPHLOGISTINE RUB A-535 EXTRA-STRENGTH OINTMENT<br />

2100050 ANTIPHLOGISTINE RUB A-535 HEAT OINTMENT<br />

2100047 ANTIPHLOGISTINE RUB A-535 ICE GEL 4% W/W<br />

9400216 ANTISPASMINA COLICA FORTE TABLETS<br />

8000418 ANTISTIN-PRIVIN EYE DROPS<br />

7300136 ANUSOL OINTMENT<br />

9500180 ANZATAX CONCENTRATE INJECTION 6MG/ML, 5ML<br />

9500181 ANZATAX CONCENTRATE INJECTION 6MG/ML, 5ML VIAL<br />

9700136 APONIL TABLETS 100MG<br />

9900284 APRESOLINE' FILM COATED TABLETS 25MG<br />

9900283 APRESOLINE SUGAR COATED TABLETS 10MG<br />

8000260 APROXAL CAPSULES 500MG<br />

8000262 APROXAL POWDER FOR ORAL SUSP. 250MG/5ML<br />

8000261 APROXAL POWDER FOR ORAL SUSPENSION 125MG/5ML<br />

8200038 APROXAL POWDER FOR ORAL SUSPENSION 500MG/5ML<br />

8400312 ARBAT FILM COATED TABLETS 200MG<br />

8400313 ARBAT FILM COATED TABLETS 400MG<br />

9900393 AREDIA POWDER FOR INJECTION 60MG WITH SOLVENT<br />

9900392 AREDIA VIALS POWDER FOR INJECTION 90MG<br />

9900522 ARESTON TABLETS 50MG<br />

9400519 ARFAREL SOLUTION 10MG/ML<br />

9800560 ARFEN PLUS TABLETS 500/50MG<br />

9800560 ARFEN PLUS TABLETS 500/50MG<br />

8400422 ARFEN SUSP. 120MG/5ML<br />

9800605 ARFEN TABLETS 100MG<br />

7700497 ARFEN TABLETS 500MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 25<br />

Code No Product<br />

9600413 ARIMIDEX TABLETS 1MG<br />

9800343 ARNETIN INJECTION 25MG/ML<br />

9200036 ARNETIN TABLETS 150MG<br />

2000480 ARNETIN TABLETS 300MG<br />

9900526 AROMASIN SUGAR COATED TABLETS 25MG<br />

8600580 ARPHOS VITAMIN B12 AMPOULES DRINKABLE<br />

9000465 ARTHRINAL FILM COATED TABLETS 20MG<br />

9700291 ARTHROTEC 75 TABLETS<br />

9500087 ARTHROXEN TABLETS 250MG<br />

9500088 ARTHROXEN TABLETS 500MG<br />

8700174 ASACOL FILM COATED TABLETS 400MG<br />

9400466 ASPEGIC 100 FOR CHILDREN AND INFANTS PDR 180MG IN SACHETS<br />

9400465 ASPEGIC 1000 POWDER 1800MG IN SACHETS<br />

9400463 ASPEGIC 500 PDR FOR INJ. 900MG VIAL WITH DILU<br />

9400464 ASPEGIC 500 POWDER 900MG IN SACHETS<br />

9600061 ASPEGIC INJECTION 1G<br />

8500070 ASPIREM ENTERIC COATED TABLETS 300MG<br />

9500253 ASPIREM ENTERIC COATED TABLETS 75MG<br />

9600145 ASS-RATIOPHARM TABLETS 100MG<br />

9500741 ASTHENAL FILM COATED TABLETS<br />

7800497 ATALINE TABLETS 5MG<br />

7000366 ATARAX SYRUP 2MG/ML<br />

7000364 ATARAX TABLETS 25MG<br />

2100072 ATASOL FOR INFANTS DROPS 80MG/ML<br />

2100073 ATASOL FORTE EXTRA STRENGTH TABLETS 500MG<br />

9600360 ATEHEXAL COMP FILM COATED TABLETS<br />

9400289 ATEHEXAL FILM COATED TABLETS 100MG<br />

9400288 ATEHEXAL FILM COATED TABLETS 50MG<br />

9400059 ATENOLOL GOLGI FILM COATED TABLETS 100MG<br />

9900571 ATENOLOL TABLETS 25MG<br />

9900572 ATENOLOL TABLETS 50MG<br />

8800618 ATENOLOL-RATIOPHARM 100 FILM COATED TABLETS 100MG<br />

7700498 ATENSIN TABLETS 40MG<br />

8000317 ATENSIN TABLETS 80MG<br />

9400346 ATGAM INJECTION 50MG/ML<br />

8900619 ATHLETE'S FOOT POWDER 1%<br />

9500002 ATHLETE'S FOOT SPRAY 1%<br />

8400603 ATODEL TABLETS 1MG<br />

8900462 ATODEL TABLETS 2MG<br />

8900463 ATODEL TABLETS 5MG<br />

7201459 ATROPINE EYE DROPS 1%<br />

9600394 ATROPINE SULPHATE INJECTION 1MG/ML


EN<br />

26 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

8500491 ATROPINE SULPHATE INJECTION 1MG/ML, 1ML<br />

9100027 ATROVENT INHALER 20MCG/METERED DOSE<br />

9600289 ATROVENT SOLUTION FOR INHALATION 250MCG/2ML<br />

8200095 AUGMENTIN FILM COATED TABLETS 375MG<br />

8900452 AUGMENTIN FILM COATED TABLETS 625MG<br />

9700126 AUGMENTIN INFANT DROPS 62.5MG/ML<br />

8600412 AUGMENTIN IV POWDER FOR INJECTION 1.2G<br />

8600411 AUGMENTIN IV POWDER FOR INJECTION 600MG<br />

8400556 AUGMENTIN POWDER FOR ORAL SUSP. 156MG/5ML<br />

8900544 AUGMENTIN POWDER FOR ORAL SUSP. 312MG/5ML<br />

9000551 AURORIX FILM COATED TABLETS 150MG<br />

9900511 AVALOX TABLETS 400MG<br />

9900119 AVANDIA TABLETS 1MG<br />

9900120 AVANDIA TABLETS 2MG<br />

9900121 AVANDIA TABLETS 4MG<br />

9900122 AVANDIA TABLETS 8MG<br />

8300488 AVANT TABLETS 1.5MG<br />

8800552 AVANT TABLETS 20MG<br />

7201226 AVEGON SUGAR COATED TABLETS<br />

9900052 AVERNOL TABLETS 25MG<br />

9900053 AVERNOL TABLETS 50MG<br />

9900051 AVERNOL TABLETS 6.25MG<br />

2000304 AVONEX POWDER FOR INJECTION 30MCG/ML, WITH SOLV IN SYRINGE<br />

8300191 AXE BRAND UNIVERSAL OIL LIQUID 10ML<br />

9400195 AXETINE POWDER FOR INJECTION 1.5G<br />

9000501 AXETINE POWDER FOR INJECTION 750MG VIAL<br />

8800604 AXID CAPSULES 150MG<br />

8800605 AXID CAPSULES 300MG<br />

9400479 AXID IV INJECTION 25MG/ML, 4ML AMP<br />

2000439 AXSAIN CREAM 0.75% W/W<br />

9700586 AZATHIOPRINE PCH POWDER FOR INJECTION 50MG<br />

9700583 AZATHIOPRINE PCH TABLETS 50MG<br />

9900235 AZATYL POWDER FOR INJECTION 1000MG WITH SOLVENT<br />

9900236 AZATYL POWDER FOR INJECTION 1000MG WITH SOLVENT<br />

9900233 AZATYL POWDER FOR INJECTION 2.000MG<br />

9900213 AZELDERM CREAM 20%<br />

9100195 AZEPTIL INJECTION 500MG/5ML<br />

9600441 AZITHROMYCIN CAPSULES 250MG<br />

9600442 AZITHROMYCIN POWDER FOR ORAL SUSP. 200MG/5ML<br />

20F0110 B COMPLEX 75 TABLETS<br />

96F0376 B COMPLEX HIGH POTENCY TABLETS<br />

95F0218 B COMPLEX TABLETS<br />

9600311 BABYRHINOL SYRUP


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 27<br />

Code No Product<br />

9300354 BACIMYCIN OINTMENT<br />

9600013 BACTIDOX TABLETS 100MG<br />

9900174 BACTOX CAPSULES 500MG<br />

9900178 BACTOX POWDER FOR INJECTION 1G<br />

9900176 BACTOX POWDER FOR INJECTION 500MG<br />

9900177 BACTOX POWDER FOR ORAL SUSPENSION 125MG/5ML<br />

9900175 BACTOX POWDER FOR ORAL SUSPENSION 250MG/5ML<br />

9900173 BACTOX POWDER FOR ORAL SUSPENSION 500MG/5ML<br />

7700186 BACTRIM FORTE FILM COATED TABLETS 800/160MG<br />

7100479 BACTRIM SYRUP 200/40MG IN 5ML<br />

9800511 BACTROBAN CREAM 2%<br />

8900453 BACTROBAN NASAL OINTMENT 2%<br />

8600120 BACTROBAN OINTMENT 2%<br />

9800564 BAMBEC ORAL SOLUTION 1MG/ML<br />

9900396 BAMIFIX SUGAR COATED TABLETS 600MG<br />

2000552 BARITOP 100 SUSPENSION 100% W/V<br />

8200015 BATRAFEN CREAM 1%<br />

9400363 BATRAFEN NAIL LAQUER SOLUTION 8%<br />

8200016 BATRAFEN SOLUTION 1%<br />

9300418 BAYCUTEN N CREAM<br />

7800565 BAYRO-GEL GEL 5%<br />

9400225 BEBEGEL MICROENEMA<br />

8700434 BECARDIN FILM COATED TABLETS 10MG<br />

8700435 BECARDIN FILM COATED TABLETS 40MG<br />

9300489 BECEDRIL CAPSULES 500MG<br />

9300490 BECEDRIL TABLETS 1G<br />

8500082 BECEVIT SUGAR COATED TABLETS<br />

9600022 BECLAZONE EASI-BREATHE INHALER 100MCG<br />

9600023 BECLAZONE EASI-BREATHE INHALER 250MCG<br />

9300567 BECLAZONE INHALER 100MCG<br />

9300568 BECLAZONE INHALER 250MCG/DOSE<br />

9400084 BECLAZONE INHALER 50MCG<br />

9600214 BECONASE AQUEOUS NASAL SPRAY 50MCG/MET.DOSE<br />

9600210 BECOTIDE INHALER 50MCG/DOSE<br />

7100411 BECOZYM FORTE SUGAR COATED TABLETS<br />

7100412 BECOZYM SYRUP<br />

9000513 BEGALIN POWDER FOR ORAL SUSP. 250MG/5ML<br />

9000514 BEGALIN-P INJECTION 1.5G VIALS<br />

9000515 BEGALIN-P POWDER FOR INJECTION 3G<br />

7700169 BEKUNIS HERB TEA<br />

7700170 BEKUNIS INSTANT TEA POWDER<br />

8000546 BELARMIN EXPECTORANT SYRUP<br />

98F0004 BENEFLORA POWDER


EN<br />

28 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

8100435 BENOXYL NO 1 LOTION 5%<br />

7900218 BENT TABLETS 5MG<br />

8600087 BEN-U-RON SUPPOSITORIES 1000MG<br />

8600084 BEN-U-RON SUPPOSITORIES 125MG<br />

8600085 BEN-U-RON SUPPOSITORIES 250MG<br />

8600086 BEN-U-RON SUPPOSITORIES 500MG<br />

8600082 BEN-U-RON SYRUP 200MG/5ML<br />

8600083 BEN-U-RON TABLETS 500MG<br />

8000275 BENYLIN CHESTY COUGHS ORIGINAL SYRUP<br />

7800<strong>227</strong> BENYLIN WITH CODEINE LIQUID<br />

9600074 BENZAMYCIN GEL<br />

8000542 BENZHEXOL TABLETS 2MG<br />

8000543 BENZHEXOL TABLETS 5MG<br />

9200380 BEPANTHEN PLUS CREAM 5%<br />

8300289 BERBERIL N EYE DROPS<br />

8400462 BERMOXEL TABLETS 600MG<br />

9200386 BEROCCA ‘ROCHE’ Ca+Mg FILM COATED TABLETS<br />

9200192 BEROCCA CALCIUM & MAGNESIUM EFFERVESCENT TABLETS<br />

7900235 BEROCIL TABLETS 4MG<br />

9100098 BESPAR TABLETS 10MG<br />

9800338 BETABIOPTAL EYE DROPS<br />

9800339 BETABIOPTAL EYE OINTMENT<br />

9200514 BETADINE CREAM 5%<br />

9900069 BETADINE THROAT SPRAY 0.45%<br />

8700023 BETAGAN EYE DROPS 0.5%<br />

8900368 BETAISODONA ALCOHOLIC SOLUTION 10%<br />

8900369 BETAISODONA ANTISEPTIC PAINT 10%<br />

9200513 BETAISODONA CREAM 5% W/W<br />

8900211 BETAISODONA GARGLE MOUTHWASH 1% W/V<br />

8900370 BETAISODONA OINTMENT 10% W/W<br />

8900142 BETAISODONA STAND. SURGICAL SCRUB SOLUTION 7.5%<br />

9100257 BETAISODONA STANDARDISED SKIN CLEANSER SOLUTION 4%<br />

8900143 BETAISODONA STANDARDIZED SOLUTION 10% W/V<br />

8900432 BETAISODONA VAGINAL DOUCHE 10%<br />

8900367 BETAISODONA VAGINAL GEL 10% W/W<br />

8900366 BETAISODONA VAGINAL PESSARIES 200MG<br />

8400115 BETALOC COMP TABLETS<br />

7700589 BETALOC TABLETS 100MG<br />

8700517 BETALOC ZOK SUSTAINED RELEASE TABLETS 100MG<br />

8700518 BETALOC ZOK SUSTAINED RELEASE TABLETS 200MG<br />

9400514 BETALOC ZOK SUSTAINED RELEASE TABLETS 50MG<br />

8300439 BETA-OPHTIOLE EYE DROPS 0.3%


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 29<br />

Code No Product<br />

8300440 BETA-OPHTIOLE EYE DROPS 0.6%<br />

9900397 BETASERC TABLETS 8MG<br />

8000019 BETASERC TABLETS 8MG<br />

9600216 BETNOVATE CREAM 0.1% W/W<br />

9600217 BETNOVATE OINTMENT 0.1% W/W<br />

9600215 BETNOVATE SCALP APPLICATION 0.1% W/W<br />

9600218 BETNOVATE-C CREAM<br />

9600219 BETNOVATE-C OINTMENT<br />

9600220 BETNOVATE-N CREAM<br />

9600221 BETNOVATE-N OINTMENT<br />

9700189 BETOPTIC EYE DROPS 0.5% W/V<br />

9700188 BETOPTIC S EYE DROPS 0.25% W/V<br />

9100168 BETRISS INJECTION 2ML AMP<br />

2000249 BEZALIP FILM COATED TABLETS 200MG<br />

2000248 BEZALIP RETARD FILM COATED TABLETS 400MG<br />

9300408 BIO DELTA CORTILEN EYE DROPS<br />

9300409 BIO DELTA CORTILEN EYE OINTMENT<br />

9600295 BIOCALYPTOL WITH PHOLCODINE SYRUP<br />

2000240 BIOCORNEAL SOLUTION<br />

8600138 BIODOX CAPSULES 100MG<br />

9600282 BIODROXIL CAPSULES 500MG<br />

9600281 BIODROXIL FILM COATED TABLETS 1000MG<br />

9600279 BIODROXIL GRANULES FOR ORAL SUSPENSION 250MG/5ML<br />

9600280 BIODROXIL GRANULES FOR ORAL SUSPENSION 500MG/5ML<br />

9900166 BIOFLOR CAPSULES 200MG<br />

9900171 BIOVIGOR SYRUP<br />

9300088 BISACODYL ENTERIC COATED TABLETS 5MG<br />

8700181 BISACODYL ENTERIC COATED TABLETS 5MG<br />

8800601 BISACODYL ENTERIC COATED TABLETS 5MG<br />

8800437 BISACODYL SUPPOSITORIES 5MG<br />

7200272 BISOLVON INJECTION 2MG/ML, 2ML<br />

9000056 BLITZ FILM COATED TABLETS 500MG<br />

8900767 BLOKIUM-DIU TABLETS<br />

8900097 BLUEBALL LOTION<br />

8900098 BLUEBALL TREATMENT SHAMPOO<br />

9900607 BOMAZANIL 3 TABLETS 3MG<br />

8400054 BONIDON SUSTAINED RELEASE CAPSULES 75MG<br />

8400053 BONIDON-100 RECTOCAPS SUPPOSITORIES 100MG<br />

9500089 BONJELA GEL<br />

2000481 BRADOSOL PLUS SUGAR-FREE LOZENGES<br />

2000482 BRADOSOL SUGAR-FREE CHERRY-MENTHOL LOZENGES 0.5MG<br />

9300091 BREXIN SUPPOSITORIES 20MG<br />

9300092 BREXIN TABLETS 20MG


EN<br />

30 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

7500235 BRICANYL INHALER 0.25MG/DOSE<br />

8600435 BRICANYL NEBULIZING SOLUTION FOR INHALATION 2.5MG/ML<br />

9000620 BRIKLIN INJECTION 250MG/ML, 2ML<br />

2000048 BROLENE EYE DROPS 0.1% W/V<br />

2000047 BROLENE EYE OINTMENT 0.15% W/W<br />

9900003 BRONCHICUM ELIXIR N SOLUTION<br />

8600554 BRONCHOPRONT LIQUID 7.5MG/ML<br />

8600553 BRONCHOPRONT SUSTAINED RELEASE CAPSULES 75MG<br />

8600555 BRONCHOPRONT SYRUP 15MG/5ML<br />

9800606 BROT FILM COATED TABLETS 850MG<br />

8400593 BROT TABLETS 500MG<br />

8400591 BRUFEN FILM COATED TABLETS 600MG<br />

9500598 BRULAMYCIN INJECTION 40MG/ML, 2ML<br />

9700187 BSS EYE DROPS<br />

9600204 BUCCO-TANTUM PASTE 0.5% W/W<br />

9600205 BUCCO-TANTUM VERDE SOLUTION 0.15% W/V<br />

8700425 BULFAN SUGAR COATED TABLETS 400MG<br />

8600192 BUMETANIDE TABLETS 1MG<br />

9300407 BURINEX A TABLETS<br />

8300453 BURINEX INJECTION 0.5MG/ML, 4ML<br />

7700471 BURINEX K TABLETS<br />

7300643 BURINEX TABLETS 1MG<br />

9300510 BURNEZE SPRAY 1%<br />

9300405 BUSCOPAN PLUS SUPPOSITORIES<br />

9300406 BUSCOPAN PLUS TABLETS<br />

9900574 BUSPIRONE TABLETS 10MG<br />

8900307 BUSPIRONE TABLETS 5MG<br />

9900573 BUSPIRONE TABLETS 5MG<br />

9800438 BUTIX GEL<br />

8900507 BUTOVENT INHALER 100MCG/DOSE<br />

9700609 BUTTERCUP HONEY & LEMON FLAVOUR LIQUID<br />

9500045 CALCI 100 INJECTION 100IU/ML<br />

9500044 CALCI 50 INJECTION 50IU/ML<br />

2000086 CALCIORAL CHEWABLE TABLETS 500MG<br />

2000085 CALCIORAL-D3 CHEWABLE TABLETS<br />

9800128 CALCITONIN GOLGI NASAL SPRAY 100IU/DOSE<br />

9700049 CALCIUM + D TABLETS<br />

9500344 CALCIUM 500 WITH D TABLETS<br />

95F0219 CALCIUM ASCORBATE POWDER<br />

8600703 CALCIUM LACTATE TABLETS 300MG<br />

8800495 CALCIUM LEUCOVORIN INJECTION 3MG, 1ML AMP<br />

8000040 CALCIUM LEUCOVORIN PDR FOR INJ. 50MG VIAL


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 31<br />

Code No Product<br />

97F0192 CALCIUM PLUS TABLETS<br />

9900300 CALCIUM SANDOZ INJECTION 10ML<br />

86F0588 CALCIUM SUPPLEMENT WITH VITAMINS A,C AND D TABLETS 150MG<br />

9400280 CALCIUMFOLINAT-EBEWE INJECTION 10MG/ML, 3ML<br />

9400279 CALCIUMFOLINAT-EBEWE INJECTION 3MG/ML AMP<br />

2000241 CALCIUM-SANDOZ FORTE EFFERVESCENT TABLETS 500MG<br />

7100426 CAL-C-VITA EFFERVESCENT TABLETS<br />

9900076 CAL-D-VITA CHEWABLE TABLETS<br />

9900075 CAL-D-VITA EFFERVESCENT TABLETS<br />

9200288 CALGEL TEETHING GEL<br />

9400524 CALMURID HC CREAM 1%<br />

9700168 CALMYLIN COUGH & FLU LIQUID<br />

9400243 CALMYLIN NO 1 LIQUID<br />

9400244 CALMYLIN NO 2 LIQUID<br />

9400245 CALMYLIN NO 3 LIQUID<br />

9400246 CALMYLIN PEDIATRIC LIQUID<br />

2000168 CALPEROS D3 TABLETS<br />

9900123 CALPEROS TABLETS 500MG<br />

8400187 CALPOL SIX PLUS SUSP. 250MG/5ML<br />

9400081 CALPOL SUGAR FREE INFANT SUSP. 120MG/5ML<br />

9500178 CALSYNAR INJECTION 100IU/ML,1ML PREF SY<br />

2000045 CALSYNAR NASAL SPRAY 200IU/DOSE<br />

9900257 CALTRATE 600 + VIT D TABLETS<br />

9400321 CAM ELIXIR 4MG/5ML<br />

8800408 CAMCOLIT FILM COATED TABLETS 400MG<br />

2100124 CAMPTO INJECTION 20MG/ML, 2ML<br />

2100125 CAMPTO INJECTION 20MG/ML, 5ML VIAL<br />

8600657 CANDIPLAS CREAM 2%<br />

8700229 CANDIPLAS H CREAM<br />

8200113 CANESTEN 1 VAGINAL TABLETS 500MG<br />

8000580 CANESTEN POWDER 1%<br />

7800514 CANESTEN VAGINAL CREAM 1%<br />

9500244 CANESTEN VAGINAL CREAM 10%<br />

9000583 CAPOTEN TABLETS 25MG<br />

9000584 CAPOTEN TABLETS 50MG<br />

9600331 CAPTOPRIL TABLETS 25MG<br />

9900575 CAPTOPRIL TABLETS 50MG<br />

8400060 CARBIMAZOLE FILM COATED TABLETS 5MG<br />

9800568 CARBOPLATIN ‘EBEWE’ VIALS 10MG/ML, 15ML<br />

3300569 CARBOPLATIN ‘EBEWE’ VIALS 10MG/ML, 45ML<br />

9800567 CARBOPLATIN ‘EBEWE’ VIALS 10MG/ML, 5ML<br />

8800488 CARBOPLATIN INJECTION 10MG/ML, 15ML<br />

9700593 CARBOSIN INJECTION 10MG/ML, 15ML


EN<br />

32 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9700594 CARBOSIN INJECTION 10MG/ML, 50ML<br />

9700592 CARBOSIN INJECTION 10MG/ML, 5ML<br />

21F0003 CARDIOACE CAPSULES<br />

8200248 CARDOXONE FILM COATED TABLETS 100MG<br />

8900622 CARDOXONE R SUSTAINED RELEASE TABLETS 200MG<br />

9700377 CARDURA TABLETS 2MG<br />

9700378 CARDURA TABLETS 4MG<br />

7700499 CARTERON CAPSULES 5MG<br />

9900052 CARVEDILOL TABLETS 25MG<br />

9900053 CARVEDILOL TABLETS 50MG<br />

9900051 CARVEDILOL TABLETS 6.25MG<br />

9900151 CASODEX TABLETS 50MG<br />

9900293 CATAFLAM DROPS 1.5%<br />

9900291 CATAFLAM SUGAR COATED TABLETS 25MG<br />

9900292 CATAFLAM SUGAR COATED TABLETS 50MG<br />

7700397 CATALIN EYE DROPS 0.75MG/ML<br />

9500398 CAVERJECT POWDER FOR INJECTION 10MCG/ML<br />

9500399 CAVERJECT POWDER FOR INJECTION 20MCG/ML<br />

7100134 CEBION EFFERVESCENT TABLETS 1000MG<br />

7101615 CECALMIN EFFERVESCENT TABLETS 1G<br />

9500003 CECLOR MR SUSTAINED RELEASE TABLETS 375MG<br />

9500004 CECLOR MR SUSTAINED RELEASE TABLETS 500MG<br />

9500005 CECLOR MR SUSTAINED RELEASE TABLETS 750MG<br />

8000055 CECLOR POWDER FOR ORAL SUSP. 125MG/5ML<br />

8000056 CECLOR POWDER FOR ORAL SUSP. 250MG/5ML<br />

8500361 CEDOCARD INFUSION 1MG/1ML, 10ML<br />

7900448 CEDOCARD SUSTAINED RELEASE TABLETS 20MG<br />

9900576 CEFADROXIL CAPSULES 500MG<br />

9900577 CEFADROXIL POWDER FOR ORAL SUSPENSION 125MG/5ML<br />

9900578 CEFADROXIL POWDER FOR ORAL SUSPENSION 250MG/5ML<br />

9900579 CEFADROXIL POWDER FOR ORAL SUSPENSION 500MG/5ML<br />

9900446 CEFALEXIN CAPSULES 250MG<br />

9900447 CEFALEXIN CAPSULES 500MG<br />

8700433 CEFAXIN CAPSULES 250MG<br />

8700432 CEFAXIN CAPSULES 500MG<br />

8700430 CEFAXIN SYRUP 125MG/5ML<br />

8700431 CEFAXIN SYRUP 250MG/5ML<br />

9400498 CEFIMED FILM COATED TABLETS 200MG<br />

9400499 CEFIMED FILM COATED TABLETS 400MG<br />

9400496 CEFIMED POWDER FOR ORAL SUSP. 100MG/5ML<br />

9900450 CEFIXIME POWDER FOR ORAL SUSP. 100MG/5ML<br />

9900448 CEFIXIME TABLETS 200MG<br />

9900449 CEFIXIME TABLETS 400MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 33<br />

Code No Product<br />

2000136 CEFPODOXIME FILM COATED TABLETS 100MG<br />

9500042 CEFRADOX CAPSULES 500MG<br />

9400285 CEFUROXIME POWDER FOR INJECTION 1.5G<br />

7000034 CELESTODERM-V CREAM 0.1%<br />

7000035 CELESTODERM-V OINTMENT 0.1%<br />

7000199 CELESTODERM-V WITH GARAMYCIN CREAM<br />

7000032 CELESTONE CHRONODOSE INJECTION 3+3MG/ML<br />

7000031 CELESTONE TABLETS 0.5MG<br />

2000051 CENOVIS ANTACID TABLETS<br />

9900160 CENOVIS ANTIOXIDANT TABLETS<br />

9900157 CENOVIS CALCIUM 600MG & VITAMIN D TABLETS<br />

9900162 CENOVIS EVENING PRIMROSE OIL CAPSULES 600MG<br />

2000577 CENOVIS EXECUTIVE B TABLETS<br />

9900158 CENOVIS GINKGO PLUS TABLETS<br />

9900163 CENOVIS MEGA E CAPSULES 500MG<br />

2000053 CENOVIS SUGARLESS C TABLETS 500MG<br />

9900159 CENOVIS VITAMIN C 1000MG ORANGE CHEWABLE TABLETS 1000MG<br />

2000052 CENOVIS VITAMIN C TABLETS 250MG<br />

9900161 CENOVIS ZINC PLUS TABLETS<br />

9100073 CENTRUM FILM COATED TABLETS<br />

9900414 CERNEVIT VIALS<br />

9900625 CETROTIDE POWDER FOR INJECTION 0.25MG<br />

9900624 CETROTIDE POWDER FOR INJECTION 3MG<br />

8800652 C-GUM (CITRUS, BLACKCURRANT) CHEWING GUM<br />

98F0599 CHARCOAL TABLETS 125MG<br />

9200459 CHARLIEU ANTI-LICE SHAMPOO<br />

97F0195 CHELATED IRON TABLETS<br />

9900184 CHEMACIN INJECTION 1G/4ML<br />

9900183 CHEMACIN INJECTION 500MG/2ML<br />

9300484 CHILBLAIN CREAM<br />

20F0025 CHILDREN'S MULTIVITAMIN CHEWABLE TABLETS<br />

8800478 CHLOROQUINE PHOSPHATE SUGAR COATED TABLETS 250MG<br />

8400062 CHLORPROMAZINE SUGAR COATED TABLETS 100MG<br />

8400069 CHLORPROMAZINE SUGAR COATED TABLETS 25MG<br />

8400063 CHLORPROMAZINE SUGAR COATED TABLETS 50MG<br />

8000549 CHLORPROPAMIDE TABLETS 250MG<br />

8500379 CHORIOMON INJECTION 5000IU WITH 2ML SOLV<br />

95F0216 CHROMIUM GTF + B3 TABLETS<br />

9900297 CIBACEN FILM COATED TABLETS 20MG<br />

9900295 CIBACEN FILM COATED TABLETS 5MG<br />

9900296 CIBACEN TABLETS 10MG<br />

9900351 CIBADREX FILM COATED TABLETS 10/12.5MG<br />

9900352 CIBADREX FILM COATED TABLETS 5/6.25MG


EN<br />

34 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9900350 CIBADREX TABLETS 20/25MG<br />

7000058 CICATRIN CREAM<br />

7000057 CICATRIN POWDER<br />

7900163 CIDOMYCIN ADULT INJECTION 40MG/ML, 2ML<br />

8900049 CIDOMYCIN EYE EAR DROPS 0.3%<br />

9500238 CIFEX TABLETS 200MG<br />

9500239 CIFEX TABLETS 400MG<br />

9600513 CILAMOX CAPSULES 500MG<br />

9800539 CILOPRINE CUM ANAESTHETICO EAR DROPS<br />

9300444 CILOX FILM COATED TABLETS 200MG<br />

9400352 CILOX FILM COATED TABLETS 400MG<br />

2000060 CILOXAN EYE OINTMENT 0.3% W/W<br />

9900451 CIMETIDINE TABLETS 200MG<br />

9900452 CIMETIDINE TABLETS 400MG<br />

9800304 CINFATOS EXPECTORANTE SYRUP<br />

8500077 CINNARIZIN FORTE-RATIOPHARM CAPSULES 75MG<br />

8200436 CINNARON TABLETS 25MG<br />

9400549 CINNARON TABLETS 75MG<br />

8700257 CIPROBAY FILM COATED TABLETS 250MG<br />

8700256 CIPROBAY FILM COATED TABLETS 500MG<br />

2000061 CIPROBAY HC EAR DROPS<br />

8700259 CIPROBAY INFUSION 2MG/ML, 100ML<br />

95F0348 CIRCUS CHEWS COMPLETE TABLETS<br />

8800493 CISPLATIN INJECTION 1MG/ML, 10ML VIALS<br />

8900439 CISPLATIN INJECTION 1MG/ML, 50ML<br />

9400282 CISPLATIN-EBEWE INJECTION 0.5MG/ML, 20ML, 100ML VIAL<br />

9700058 CITIVIR CREAM 5%<br />

9700056 CITIVIR ORAL SUSPENSION 100ML<br />

9700059 CITIVIR TABLETS 200MG<br />

8200061 CLAFORAN IM POWDER FOR INJECTION 1GVIAL WITH 4ML SOLV<br />

8200062 CLAFORAN IV POWDER FOR INJECTION 1G<br />

8000017 CLARANTIN CAPSULES 100MG<br />

2000218 CLAREM FILM COATED TABLETS 250MG<br />

2000219 CLAREM FILM COATED TABLETS 500MG<br />

9300079 CLARIDYNE D TABLETS<br />

9900071 CLARITHROMYCIN FILM COATED TABLETS 250MG<br />

9900582 CLARITHROMYCIN SUSP. 125MG/5ML<br />

9900580 CLARITHROMYCIN TABLETS 250MG<br />

9900581 CLARITHROMYCIN TABLETS 500MG<br />

8900233 CLARITINE TABLETS 10MG<br />

8900499 CLENIGEN OTO EAR DROPS<br />

8900534 CLENIL COMPOSITUM INHALER<br />

8900501 CLENIL FORTE SPRAY 250MCG/DOSE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 35<br />

Code No Product<br />

8900533 CLENIL INHALER 50MCG/DOSE<br />

9000386 CLERIDIUM TABLETS 150MG<br />

9900146 CLERON POWDER FOR ORAL SUSP. 125MG/5ML<br />

9500119 CLEXANE 100 INJECTION 10000ANTI-XAIU<br />

2100080 CLEXANE INJECTION 20MG(2000IU)/0.2ML<br />

2100081 CLEXANE INJECTION 40MG(4000IU)/0.4ML<br />

2100082 CLEXANE INJECTION 80MG(8000IU)/0.8ML<br />

2000138 CLINAMEL N7-1000 INFUSION<br />

9300165 CLINDAN CAPSULES 150MG<br />

9900415 CLINIMIX N14G30E INJECTION<br />

9900417 CLINIMIX N17G35 INJECTION<br />

9900416 CLINIMIX N9G20E INJECTION<br />

9900620 CLINOLEIC /INFUSION 20%<br />

2000137 CLINOMEL N4-550 INFUSION<br />

7800444 CLINORIL TABLETS 200MG<br />

9600157 CLOMID TABLETS 50MG<br />

9400074 CLOMIPHEN CITRATE TABLETS 50MG<br />

8500208 CLOMIPRAMINE SUGAR COATED TABLETS 25MG<br />

9900453 CLOMIPRAMINE TABLETS 10MG<br />

9900454 CLOMIPRAMINE TABLETS 25MG<br />

9900455 CLOMIPRAMINE TABLETS 50MG<br />

8300437 CLOMIPRAN FILM COATED TABLETS 25MG<br />

9500043 CLOMIPRAN TABLETS 10MG<br />

8900241 CLONAL TABLETS 0.5MG<br />

8900240 CLONAL TABLETS 2MG<br />

8200238 CLOPERAN TABLETS 10MG<br />

8200024 CLOPIXOL DEPOT INJECTION 200MG/ML<br />

8700064 CLOPIXOL/ACUPHASE INJECTION 50MG/ML<br />

8500384 CLORAZEPATE DIPOTASSIUM CAPSULES 10MG<br />

8500383 CLORAZEPATE DIPOTASSIUM CAPSULES 5MG<br />

9900456 CLOXACILLIN CAPSULES 250MG<br />

9900169 CLOXACILLIN CAPSULES 500MG<br />

9900457 CLOXACILLIN CAPSULES 500MG<br />

9400103 CLOXILAN CAPSULES 250MG<br />

9400104 CLOXILAN CAPSULES 500MG<br />

99F0047 CO ENZYME Q10 CAPSULES 30MG<br />

9500007 CO-CODAMOL TABLETS<br />

2000184 COCOIS OINTMENT<br />

8900317 CODACIN FILM COATED TABLETS 250MG<br />

8700491 CODALIDAZONE TABLETS 200MG<br />

8900226 CODANOL FILMCOATED TABLETS 100MG<br />

9200551 CODANOL TABLETS<br />

8200027 CODIPRONT CUM EXPECTORANS SUSTAINED RELEASE CAPSULES


EN<br />

36 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

8100572 CODIPRONT CUM EXPECTORANS SYRUP<br />

8100563 CODIPRONT SUSTAINED RELEASE CAPSULES<br />

8100564 CODIPRONT SYRUP<br />

9500090 CODIS 500 TABLETS<br />

8900087 COLCHICINE HOUDE TABLETS 1MG<br />

8100565 COLLOMACK SOLUTION<br />

8800101 COLMIFEN TABLETS 10MG<br />

8500466 COLPOCIN-T INFUSION 5MG/ML, 100ML<br />

9500481 COMBIVENT METERED DOSE INHALER<br />

9800453 COMBIVIR TABLETS<br />

9800239 COMTAN TABLETS 200MG<br />

9500022 COMTREX COLD FILM COATED TABLETS<br />

9700318 COMTREX MAXIMUM STRENGTH COLD AND FLU RELIEF FC TABLETS<br />

7500294 CONCAVIT CAPSULES<br />

9000023 CONCOR FILM COATED TABLETS 10MG<br />

9000022 CONCOR FILM COATED TABLETS 5MG<br />

9900238 CONSUMONIT INJECTION 250MG/ML, 2ML<br />

9900033 CONTAC 400 CAPSULES 4MG/50MG<br />

7400406 CONTRACTUBEX COMPOSITUM OINTMENT<br />

9800489 CONTROLOC GASTRO-RESISTANT TABLETS 40MG<br />

9900399 CONTROLOC TABLETS 20MG<br />

99F0098 CO-Q-10 GOLD CAPSULES<br />

2000524 CORDARONE INJECTION 50MG/ML, 3ML AMPS<br />

2000523 CORDARONE TABLETS 200MG<br />

8900334 CO-RENITEC TABLETS<br />

8100571 CORITUSSAL SUSTAINED RELEASE CAPSULES<br />

8100566 CORITUSSAL SYRUP<br />

9700072 COROTREND CR FILM COATED TABLETS 40MG<br />

8800476 COROTROPE ENTERIC COATED TABLETS 2.5MG<br />

8800477 COROTROPE ENTERIC COATED TABLETS 5MG<br />

8000565 COROTROPE TABLETS 5MG<br />

7000127 CORTIPHENOL H EYE OINTMENT<br />

8500260 CORTISONE ACETATE TABLETS 25MG<br />

9800516 COSOPT OPHTHALMIC SOLUTION 2%/0.5%<br />

8800553 COSTI SUPPOSITORIES 30MG<br />

8700338 COTINAZIN CREAM 1%<br />

9000045 COTINAZIN POWDER 1%<br />

9000044 COTINAZIN SPRAY 1%<br />

8500223 COTRIM FORTE-RATIOPHARM TABLETS 800/160MG<br />

8400423 COTRIM SUSP. 200/40MG IN 5ML<br />

7700500 COTRIM TABLETS 400/80MG<br />

9400049 COUNTERPAIN CREAM<br />

9000464 COVERSYL TABLETS 4MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 37<br />

Code No Product<br />

9500124 COZAAR FILM COATED TABLETS 50MG<br />

9900510 CREON 10000 CAPSULES 150MG<br />

9500550 CREON CAPSULES 300MG<br />

7500072 CRESOPHENE SOLUTION<br />

2000158 CRIED FACTOR VIII, 8Y POWDER 250IU<br />

9900144 CRIXIVAN CAPSULES 333MG<br />

9600183 CRIXIVAN CAPSULES 400MG<br />

9300430 CROMOHEXAL EYE DROPS 2%<br />

9300431 CROMOHEXAL NASAL SPRAY 2%<br />

9800313 CRUPODEX WOUND CLEANSING POWDER 60G<br />

2000185 CRYSTACIDE CREAM 1%<br />

9900039 CURAM FILM COATED TABLETS 625MG<br />

9900041 CURAM FORTE POWDER FOR ORAL SUSPENSION 312.5MG/5ML<br />

9900040 CURAM POWDER FOR ORAL SUSPENSION 156.25MG/5ML<br />

9300093 CUROSURF INJECTION 80MG/ML<br />

8900208 CUSITRIN LOTION 0.3%<br />

8900209 CUSITRIN SHAMPOO 0.4%<br />

9600468 CUTIVATE CREAM 0.05%<br />

9600469 CUTIVATE OINTMENT 0.005%<br />

9700186 CYCLOGYL EYE DROPS 1% W/V<br />

8900396 CYCLOVAX CREAM 5%<br />

8800504 CYCLOVAX TABLETS 200MG<br />

9400254 CYCLOVAX TABLETS 400MG<br />

9500619 CYCLOVAX TABLETS 800MG<br />

9500669 CYMEVENE POWDER FOR INJECTION 500MG VIAL<br />

8800490 CYTARABINE PDR FOR INJ. 100MG WITH 10ML DILU<br />

9400436 CYTOSAR PDR FOR INJ. 100MG<br />

8800616 CYTOTEC TABLETS 200MCG<br />

8800515 D T COQ INJECTION 0.5ML<br />

8800518 D T VAX INJECTION 0.5ML SYRINGE<br />

9300438 DAIVONEX CREAM 50MCG/G<br />

9100020 DAIVONEX OINTMENT 0.005%<br />

9900186 DAIVONEX SCALP SOLUTION 50MCG/ML<br />

7800554 DAKTACORT CREAM<br />

7600449 DAKTARIN CREAM 2%<br />

7900086 DAKTARIN LOTION 2%<br />

7900085 DAKTARIN ORAL GEL 2%<br />

7600450 DAKTARIN POWDER 2%<br />

7900088 DAKTARIN TINCTURE 2%<br />

8100140 DALACIN C INJECTION 150MG/ML, 4ML AMP<br />

9400258 DALACIN T GEL 1%<br />

9700139 DALACIN VAGINAL CREAM 2%<br />

8700123 DANODIOL CAPSULES 200MG


EN<br />

38 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

7100153 DAONIL TABLETS 5MG<br />

9000216 DAPRIL TABLETS 10MG<br />

9000217 DAPRIL TABLETS 20MG<br />

9000215 DAPRIL TABLETS 5MG<br />

8400120 DARAPRIM TABLETS 25MG<br />

9300462 DAZIL TABLETS 30MG<br />

9300463 DAZIL TABLETS 60MG<br />

9500696 DAZIL TABLETS 90MG<br />

9800517 DEBRISAN BEADS 60G<br />

7100740 DECADRON ELIXIR 0.5MG/5ML<br />

7100735 DECADRON EYE EAR DROPS 0.1%<br />

7100734 DECADRON INJECTION 4MG/ML, 2ML VIAL<br />

7100738 DECADRON TABLETS 0.5MG<br />

7100736 DECADRON WITH NEOMYCIN EYE EAR DROPS<br />

9300366 DECAPEPTYL INJECTION 0.1MG<br />

9300367 DECAPEPTYL POWDER FOR INJECTION 3.75MG<br />

9100371 DECLOBAN OINTMENT<br />

7100671 DECTANCYL TABLETS 0.5MG<br />

9900083 DELABARRE GEL<br />

9600313 DELTARHINOL NASAL SPRAY<br />

8100387 DENEX TABLETS 100MG<br />

9900256 DENSICAL EFFERVESCENT TABLETS 600MG<br />

9400472 DENTINOX COLIC ORAL DROPS 42MG/5ML<br />

9400471 DENTINOX TEETHING GEL<br />

2000522 DEPAKINE CHRONO TABLETS 500MG<br />

2000521 DEPAKINE GASTRO-RESISTANT TABLETS 500MG<br />

7000497 DEPO-MEDROL INJECTION 40MG/ML, 1ML<br />

9400372 DEPO-MEDROL SUSP. FOR INJ.40MG/ML, 2ML<br />

9400159 DEPO-MEDROL SUSP. FOR INJ.40MG/ML, 5ML<br />

9900270 DEPON EFFERVESCENT TABLETS 1G<br />

9900079 DEPON EFFERVESCENT TABLETS 500MG<br />

9900269 DEPON SOLUTION 100MG/ML<br />

9200311 DEPON SYRUP 120MG/5ML<br />

9200312 DEPON TABLETS 500MG<br />

8400330 DEPON VIT C EFFERVESCENT TABLETS<br />

8300420 DEPRIM SUSP. 200/40MG IN 5ML<br />

8100060 DEPRIM TABLETS 400/80MG<br />

9200291 DERM-AID CREAM 0.5% W/W<br />

9600224 DERMOVATE CREAM 0.05% W/W<br />

9600225 DERMOVATE OINTMENT 0.05% W/W<br />

9600226 DERMOVATE SCALP APPLICATION 0.05% W/W<br />

9600222 DERMOVATE-NN CREAM<br />

9600223 DERMOVATE-NN OINTMENT


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 39<br />

Code No Product<br />

9900520 DESFERAL INJECTION 2G/VIALS<br />

9900279 DESFERAL POWDER FOR INJECTION 500MG<br />

8300002 DESIREL TABLETS 50MG<br />

9400278 DESITIN POWDER 11G/100G<br />

9500008 DESITIN SPRAY<br />

8900150 DESOMEDINE EYE DROPS 0.1%<br />

8000550 DESTIROL FILM COATED TABLETS<br />

2100128 DETICENE POWDER FOR INJECTION 100MG/VIAL<br />

8100523 DEVODIL TABLETS 50MG<br />

2000236 DEXA RHINASPRAY N NASAL SPRAY<br />

9500465 DEXA-GENTAMICIN EYE DROPS<br />

9100220 DEXAMED ELIXIR 0.5MG/5ML<br />

9000479 DEXAMED INJECTION 4MG/ML, 2ML<br />

7900219 DEXAMED TABLETS 0.5MG<br />

9800124 DEXAMETHASONE/GENEPHARM INJECTION 4MG/ML, 2ML<br />

9800382 DEXTROSE (COOPER) INJECTION 5%, 500ML<br />

9400100 DEXTROSE 5% IV INFUSION PAR. SOL. 5%, 500ML<br />

9100379 DEXTROSE 5% IV INFUSION PARENTERAL SOLUTION 5%, 1000ML BOTTLES<br />

9500605 DEXTROSE 5% W/V PARENTERAL SOLUTION 1000ML<br />

96F0374 DIABETONE CAPSULES<br />

8500606 DIALENS EYE DROPS<br />

8200164 DIAMICRON TABLETS 80MG<br />

8900256 DIAZEM FILM COATED TABLETS 30MG<br />

9000169 DIAZEPAM INJECTION 5MG/ML, 2ML<br />

9500659 DICETEL FILM COATED TABLETS 50MG<br />

9700080 DICLAC INJECTION 75MG<br />

9700081 DICLAC TABLETS 25MG<br />

9900522 DICLOFENAC POTASSIUM TABLETS 50MG<br />

8500478 DICLOFENAC-RATIOPHARM ENTERIC COATED TABLETS 50MG<br />

8500479 DICLOFENAC-RATIOPHARM INJECTION 37.5MG/ML, 2ML<br />

8600501 DICLOFENAC-RATIOPHARM SUPPOSITORIES 100MG<br />

8600499 DICLOFENAC-RATIOPHARM SUSTAINED RELEASE CAPSULES 100MG<br />

9900641 DICLOFENAC-RATIOPHARM UNO POLONGED RELEASE TABLETS 150MG<br />

9100274 DICLOREUM ENTERIC COATED TABLETS 50MG<br />

9100162 DICLOREUM SUPPOSITORIES 100MG<br />

9000093 DICLOREUM SUSTAINED RELEASE TABLETS 100MG<br />

9900583 DICLOXACILLIN CAPSULES 250MG<br />

9900584 DICLOXACILLIN CAPSULES 500MG<br />

9400233 DICLOXIL CAPSULES 250MG<br />

9400234 DICLOXIL CAPSULES 500MG<br />

9400158 DICYNONE 500 TABLETS 500MG<br />

8500517 DICYNONE TABLETS 250MG<br />

9900096 DIENOESTROL ORTHO CREAM 0.01%


EN<br />

40 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

8600135 DIFENAC ENTERIC COATED TABLETS 50MG<br />

9900531 DIFFLAM ANTI-INFLAMMATORY WITH COUGH SUPPRESSANT LOZENGES<br />

8200037 DIFFLAM CREAM 3%<br />

9900398 DIFFLAM GEL<br />

8700252 DIFFLAM ORAL RINSE LIQUID 0.15%<br />

8700251 DIFFLAM SPRAY 0.15%<br />

9900224 DIFFLAM TM ANT I INFLAMMATORY LOZENGES<br />

9700053 DIFFUSIL H 92-P SPRAY<br />

8400298 DIFLERIX CAPSULES 2.5MG<br />

8400306 DIKACINE INJECTION 75MG IN 1.5ML AMP<br />

2000220 DILAPAN CAPSULES 150MG<br />

9900277 DILATREND TABLETS 25MG<br />

9900276 DILATREND TABLETS 6.25MG<br />

9900458 DILTIAZEM TABLETS 30MG<br />

9900459 DILTIAZEM TABLETS 60MG<br />

9900460 DILTIAZEM TABLETS 90MG<br />

8300204 DILZEM TABLETS 60MG<br />

7800461 DIMA TABLETS 5MG<br />

2000049 DIORALYTE RELIEF SACHETS<br />

9900384 DIOVAN CAPSULES 160MG<br />

9900383 DIOVAN CAPSULES 80MG<br />

9900519 DIOVAN HCT (CO-DIOVAN) TABLETS 160/12.5MG<br />

2100069 DIOVOL EXTRA STRENTH SUSPENSION<br />

2100071 DIOVOL PLUS AF TABLETS<br />

2100070 DIOVOL PLUS TROPICAL FRUIT SUSPENSION<br />

8600745 DIPRIVAN INJECTION 10MG/ML, 20ML AMP<br />

8900147 DIPROFOS INJECTION 2+5MG/ML, 2ML AMP<br />

8700132 DIPROGENTA CREAM<br />

8600738 DIPROSALIC LOTION<br />

8600806 DIPROSALIC OINTMENT<br />

7900294 DISFLATYL CHEWABLE TABLETS 40MG<br />

9900412 DISFLATYL EMULSION 40MG/ML<br />

8100180 DISIPAL TABLETS 50MG<br />

9500624 DISPAGENT EYE DROPS 5MG/5ML<br />

9500625 DISPAGENT EYE OINTMENT 5MG/G<br />

2000494 DISPRIN DIRECT DISPERSIBLE TABLETS 300MG<br />

2000493 DISPRIN EXTRA TABLETS<br />

8000207 DISPRIN TABLETS 300MG<br />

9900278 DISPROL PARACETAMOL SUSPENSION 120MG/5ML<br />

7300791 DISTALGESIC TABLETS<br />

2000610 DITROPAN SCORED TABLETS 5MG<br />

9600046 DOBUTAMINE HCL INJECTION 12.5MG/ML, 20ML<br />

9500097 DOGMATIL CAPSULES 50MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 41<br />

Code No Product<br />

9500100 DOGMATIL TABLETS 200MG<br />

7800509 DOLOBID TABLETS 250MG<br />

8700437 DOLOGESIC FILM COATED TABLETS<br />

8700284 DOLO-NEUROBION N FILM COATED TABLETS<br />

7500299 DOLVAN SUGAR COATED TABLETS<br />

8800487 DOPAMINE HCL INJECTION 40MG/ML, 5ML<br />

8300271 DOPERGIN TABLETS 0.2MG<br />

8900162 DORMICUM FILM COATED TABLETS 7.5MG<br />

9800169 DOSTINEX TABLETS 0.5MG<br />

9400036 DOXAT CAPSULES 100MG<br />

9300413 DOXAT FILM COATED TABLETS 100MG<br />

9300412 DOXAT TABLETS 50MG<br />

9800303 DOXAZOCIN TABLETS 4MG<br />

8400247 DOXILEN CAPSULES 100MG<br />

8500391 DOXILEN FILM COATED TABLETS 100MG<br />

8500522 DOXIPROCT PLUS SUPPOSITORIES<br />

8500519 DOXIPROCT SUPPOSITORIES<br />

8500520 DOXIVENIL GEL<br />

9700591 DOXORUBIN INJECTION 2MG/ML, 100ML<br />

9700589 DOXORUBIN INJECTION 2MG/ML, 10ML<br />

9700590 DOXORUBIN INJECTION 2MG/ML, 25ML<br />

9700588 DOXORUBIN INJECTION 2MG/ML, 5ML<br />

8200078 DOXY 200 CAPSULES 200MG<br />

8100460 DOXY KOMB CAPSULES 100MG(+ONE 200MGCAP)<br />

9900585 DOXYCYCLINE TABLETS 100MG<br />

8500078 DOXYCYCLINE-RATIOPHARM 100 CAPSULES 100MG<br />

9100067 DOXY-M-RATIOPHARM TABLETS 100MG<br />

2000159 DRIED FACTOR VIII, 8Y POWDER 500IU<br />

9200258 DRILL LOZENGES<br />

8700292 DROXARYL CREAM 5%<br />

7700097 DUINUM TABLETS 50MG<br />

7700098 DULCOLAX SUGAR COATED TABLETS 5MG<br />

7700099 DULCOLAX SUPPOSITORIES 10MG<br />

8400392 DUMOXIN FILM COATED TABLETS 100MG<br />

8400394 DUMOZOL FILM COATED TABLETS 500MG<br />

8400393 DUMOZOL TABLETS 250MG<br />

8000020 DUPHALAC SYRUP 3.35G/5ML<br />

8000156 DUPHASTON TABLETS 10MG<br />

8600134 DURAMOX CAPSULES 250MG<br />

8600133 DURAMOX CAPSULES 500MG<br />

8600131 DURAMOX POWDER FOR ORAL SUSPENSION 250MG/5ML<br />

8600130 DURAMOX POWDER FOR ORAL SUSPENSION 500MG/5ML<br />

8600132 DURAMOX SYRUP 125MG/5ML


EN<br />

42 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9900187 DUROGESIC 75MCG/H<br />

9600004 DUSPATALIN RETARD CAPSULES 200MG<br />

8400464 DUSPATALIN SUGAR COATED TABLETS 135MG<br />

8400463 DUSPATALIN SUSP. 50MG/5ML<br />

9000326 DYAZIDE TABLETS<br />

9400480 DYNABAC ENTERIC COATED TABLETS 250MG<br />

9000348 DYSPAMET ORAL SUSP. 200MG/5ML<br />

95F0<strong>227</strong> E.P.A. CAPSULES<br />

95F0229 E500 TABLETS<br />

2000538 EBASTEL SOLUTION 1MG/ML<br />

2000537 EBASTEL TABLETS 10MG<br />

20F0038 ECHINACEA CAPSULES 350MG<br />

9700618 ECHOVIST-200 PDR FOR INJ. 3G WITH SOLVENT<br />

9300494 ECO GEL 1%<br />

9300495 ECO SOLUTION 1%<br />

9300493 ECO TOPICAL POWDER 1%<br />

8700428 EDAMOX CAPSULES 250MG<br />

8700427 EDAMOX CAPSULES 500MG<br />

8700438 EDAMOX POWDER FOR ORAL SUSPENSION 125MG/5ML<br />

8700429 EDAMOX POWDER FOR ORAL SUSPENSION 250MG/5ML<br />

7900<strong>227</strong> EDERMA CREAM<br />

9800497 EFACAL CAPSULES<br />

9800495 EFAMOL PMP EXTRA STRENGTH CAPSULES<br />

9500594 EFEXOR TABLETS 37.5MG<br />

9500595 EFEXOR TABLETS 50MG<br />

9500596 EFEXOR TABLETS 75MG<br />

9900093 EFEXOR XR CAPSULES 15OMG<br />

9900092 EFEXOR XR CAPSULES 75MG<br />

7200876 EFFORTIL TABLETS 5MG<br />

9800130 ELBAT TABLETS 25OMG<br />

9800480 ELDOPAQUE FORTE CREAM 4%<br />

9800478 ELDQQUIN FORTE CREAM 4%<br />

9400368 ELECTROLADE SACHETS<br />

2000024 ELECTRORICE SACHETS<br />

9200323 ELEVIT PRONATAL FILM COATED TABLETS<br />

9900214 ELINAP ORAL POWDER 10OMG<br />

9900211 ELINAP TABLETS 10OMG<br />

9000480 ELITAN INJECTION 5MG/ML, 2ML<br />

8900231 ELITAN SUPPOSITORIES 10MG<br />

8900230 ELITAN SUPPOSITORIES 20MG<br />

7900212 ELITAN TABLETS 10MG<br />

9000424 ELMETACIN SPRAY SOLUTION 1%<br />

8000018 ELMETIN TABLETS 100MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 43<br />

Code No Product<br />

9500009 ELOCON CREAM 0.1%<br />

9500010 ELOCON LOTION 0.1%<br />

9500011 ELOCON OINTMENT 0.1%<br />

9300069 ELOQUINE TABLETS 250MG<br />

9300450 ELYZOL DENTAL GEL 25%<br />

2000063 EMADINE EYE DROPS 0.05% W/V<br />

8100522 EMFORAL FILM COATED TABLETS 10MG<br />

8000568 EMFORAL FILM COATED TABLETS 40MG<br />

8700124 EMFORAL FILM COATED TABLETS 80MG<br />

9000179 EMLA CREAM<br />

9400439 EMLA PATCH TRANSDERMAL SYSTEM<br />

9900422 EMTHEXATE 10 TABLETS 10MG<br />

9900423 EMTHEXATE PF INJECTION 100MG/ML<br />

9900424 EMTHEXATE PF INJECTION 2.5MG/ML<br />

9700596 EMTHEXATE PF INJECTION 25MG/ML, 10ML<br />

9700599 EMTHEXATE PF INJECTION 25MG/ML, 200ML<br />

9700595 EMTHEXATE PF INJECTION 25MG/ML, 2ML<br />

9700598 EMTHEXATE PF INJECTION 25MG/ML, 40ML<br />

9900428 EMTHEXATE TABLETS 2.5MG<br />

9400051 ENALAPRIL GOLGI TABLETS 20MG<br />

9400467 ENALAPRIL GOLGI TABLETS 5MG<br />

9400441 ENALAPRIL RATIOPHARM TABLETS 20MG<br />

9600278 ENALAPRIL RATIOPHARM TABLETS 5MG<br />

2000234 ENATEC-10 TABLETS 10MG<br />

7100243 ENCEPHABOL LIQUID 16MG/ML<br />

7100140 ENCEPHABOL SUGAR COATED TABLETS 100MG<br />

9400236 ENDOPRYL TABLETS 5MG<br />

8400076 ENDOXAN PDR FOR INJ. 1G<br />

7300069 ENDOXAN PDR FOR INJ. 200MG<br />

8400075 ENDOXAN PDR FOR INJ. 500MG<br />

7300067 ENDOXAN SUGAR COATED TABLETS 50MG<br />

9000378 ENGERIX B PEDIATRIC SUSP. FOR INJ.10MCG PER 0.5ML<br />

9000379 ENGERIX-B SUSP. FOR INJ.20MCG/ML, 1ML<br />

7500331 ENO FRUIT SALT (ORIGINAL, LEMON) POWDER<br />

9600316 ENTOCORT CAPSULES 3MG<br />

9400438 ENTOCORT ENEMA 0.02MG/ML<br />

9700662 EPADOREN SYRUP 75MG/5ML<br />

8900243 EPALON FILM COATED TABLETS 25MG<br />

8900244 EPALON FILM COATED TABLETS 50MG<br />

8000284 EPANUTIN CAPSULES 100MG<br />

7100428 EPHYNAL CHEWABLE SUGAR COATED TABLETS 100MG<br />

8600664 EPOKELAN LOTION 2%<br />

9900074 EPREX PRE-FILLED SYRINGE 10000IU/ML


EN<br />

44 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9900072 EPREX PRE-FILLED SYRINGE 1000IU/0.5ML<br />

9800578 EPREX PRE-FILLED SYRINGE 2000IU/0.5ML<br />

9900073 EPREX PRE-FILLED SYRINGE 3000IU/0.3ML<br />

9800577 EPREX PRE-FILLED SYRINGE 4000IU/0.4ML<br />

8500258 EPSITRON TABLETS 25MG<br />

8800535 EPSITRON TABLETS 50MG<br />

9400462 ERCEFURYL CAPSULES 200MG<br />

9400461 ERCEFURYL ORAL SUSP. 200MG/5ML<br />

8800376 ERMYCED POWDER FOR ORAL SUSP. 125MG/5ML<br />

8800377 ERMYCED POWDER FOR ORAL SUSP. 250MG/5ML<br />

8800378 ERMYCED POWDER FOR ORAL SUSP. 500MG/5ML<br />

8400065 ERMYCIN FILM COATED TABLETS 250MG<br />

9400189 ERMYCIN FILM COATED TABLETS 500MG<br />

9000380 ERVEVAX PDR FOR INJ. 1000TCID50+0.5MLSOLV<br />

9000211 ERY-DIOLAN GRANULES FOR ORAL SUSPENSION 200MG/5ML<br />

2000414 ERYTHRAN TABLETS 250MG<br />

7700070 ERYTHROCIN FILM COATED TABLETS 500MG<br />

8600525 ERYTHROCIN GRANULES FOR ORAL SUSPENSION 250MG/5ML<br />

8100507 ERYTHROCIN POWDER FOR ORAL SUSPENSION 500MG/5ML<br />

8700494 ERYTHROMYCIN ESTOLATE CAPSULES 250MG<br />

9100122 ERYTHROMYCIN LACTOBIONATE POWDER FOR INJECTION 1G<br />

2000409 ERYTHROMYCIN TABLETS 250MG<br />

2000408 ERYTHROMYCIN TABLETS 500MG<br />

9900125 ESCINOGEL GEL<br />

9800205 ESMERON INJECTION 250MG=25ML VIALS<br />

9400067 ESSELDON FILM COATED TABLETS 20MG<br />

9400068 ESSELDON FILM COATED TABLETS 40MG<br />

9600308 ESTIVAL SYRUP 250MG/5ML<br />

9900298 ESTRACOM TRANSDERMAL SYSTEM 5OMG<br />

9900230 ESTRACYT POWDER FOR INJECTION WITH DILUENT<br />

9900386 ESTRADERM MX 100 TRANSDERMAL SYSTEM 3MG<br />

9900387 ESTRADERM MX 25 TRANSDERMAL SYSTEM 0.75 MG<br />

9900388 ESTRADERM MX 50 TRANSDERMAL SYSTEM 1.5 MG<br />

9900289 ESTRADERM TTS TRANSDERMAL SYSTEM 25MCG<br />

9900288 ESTRADERM TTS TRANSDERMAL SYSTEM 50MCG<br />

9100144 ESTROFEM FILM COATED TABLETS 2MG<br />

9800518 ETHAMBUTOL TABLETS 400MG<br />

9900034 ETHYOL POWDER FOR INJECTION 500MG<br />

9800260 ETIDRONATE GOLGI CAPSULES 400MG<br />

9600377 EUCARBON TABLETS<br />

2000117 EUGLUCON FILM COATED TABLETS 5MG<br />

9600<strong>227</strong> EUMOVATE CREAM 0.05% W/W


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 45<br />

Code No Product<br />

9600228 EUMOVATE OINTMENT 0.05% W/W<br />

8700067 EUPRES TABLETS<br />

9700444 EURAX CREAM 10%<br />

9700443 EURAX LOTION 10%<br />

9600116 EUTHYROX TABLETS 100MCG<br />

9600115 EUTHYROX TABLETS 50MCG<br />

95F0079 EVENING PRIMROSE OIL + VITAMIN E CAPSULES<br />

95F0214 EVENING PRIMROSE OIL CAPSULES<br />

2000112 EVENING PRIMROSE OIL SOFT GELATIN CAPSULES<br />

7100141 EVION SUGAR COATED TABLETS 100MG<br />

9800537 EVOREL 50 TRANSDERMAL SYSTEM 3.2MG<br />

9900518 EXELON SOLUTION 2MG/ML<br />

8800214 EXODERIL CREAM 1%<br />

8800213 EXODERIL SOLUTION 1%<br />

8500445 EXOLIT ELIXIR 4MG/5ML<br />

9900212 EZIPOL ENTERIC COATED CAPSULES 20MG<br />

9000405 FALCISTAT TABLETS<br />

9400255 FAMOPSIN AC FILM COATED TABLETS 10MG<br />

9500373 FAMVIR TABLETS 125MG<br />

9400235 FAMVIR TABLETS 250MG<br />

8500462 FAST POWDER<br />

9000331 FEFOL SPANSULE SUSTAINED RELEASE CAPSULES<br />

9000332 FEFOL Z SPANSULE SUSTAINED RELEASE CAPSULES<br />

8800343 FELDENE DISPERSIBLE TABLETS 10MG<br />

8800344 FELDENE DISPERSIBLE TABLETS 20MG<br />

9000308 FELDENE GEL 0.5%<br />

9400373 FELDENE IM INJECTION 20MG/ML, 1ML<br />

8900753 FELDENE SUPPOSITORIES 20MG<br />

9400105 FELEXIN FORTE FILM COATED TABLETS 1000MG<br />

8200490 FELEXIN POWDER FOR ORAL SUSPENSION 250MG/5ML<br />

9900385 FEMARA TABLETS 2.5MG<br />

8900076 FENAMON SR SUSTAINED RELEASE TABLETS 20MG<br />

8900336 FENAMON TABLETS 10MG<br />

9000345 FENBID SUSTAINED RELEASE CAPSULES 300MG<br />

9500355 FENISTIL 24 SUSTAINED RELEASE CAPSULES 4MG<br />

8400321 FENISTIL GEL 0.1%<br />

8400324 FENISTIL ORAL DROPS 1MG/ML(=20 DROPS)<br />

8400325 FENISTIL SYRUP 0.5MG/5ML<br />

8800496 FENTANYL CITRATE INJECTION 50MCG/ML, 2ML<br />

7800546 FENTANYL INJECTION 50MCG BASE/ML, 10ML<br />

8600526 FERO-FOLIC-500 FILM COATED TABLETS<br />

88F0434 FEROGLOBIN CAPSULES<br />

94F0276 FEROGLOBIN-B12 LIQUID


EN<br />

46 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9900496 FERRIPROX TABLETS 500MG<br />

8400647 FERROUS FUMARATE FILM COATED TABLETS 200MG<br />

9600421 FERROUS GLUCONATE FILM COATED TABLETS 300MG<br />

8500300 FERTILAN TABLETS 50MG<br />

9400072 FIBROLIP FILM COATED TABLETS 600MG<br />

8500555 FILOCOT CREAM 1%<br />

8900306 FLAMON-120 TABLETS 120MG<br />

8900305 FLAMON-80 FILM COATED TABLETS 80MG<br />

7100713 FLAVACO NASAL SPRAY<br />

7100714 FLAVACO WITH HYDROCORTISONE OTIC DROPS<br />

7300091 FLAVEDRIN MILD NASAL DROPS<br />

7300338 FLAVEDRIN NASAL DROPS<br />

9200359 FLAVOBION-C POWDER IN SACHETS<br />

2000100 FLECOR-N FILM COATED TABLETS 20MG<br />

8500530 FLECOXIN ELIXIR 4MG/5ML<br />

9400178 FLEET BABYLAX ENEMA<br />

8500339 FLEET GLYCERIN FOR INFANTS SUPPOSITORIES 2G<br />

8500341 FLEET GLYCERIN SUPPOSITORIES<br />

7800098 FLEET MINERAL OIL ENEMA 100%<br />

9500054 FLEET MINERAL OIL LIQUID<br />

9400295 FLEXASE TABLETS 10MG<br />

9400296 FLEXASE TABLETS 20MG<br />

9700061 FLEXEN CAPSULES 50MG<br />

9700060 FLEXEN GEL 2.5%<br />

8400261 FLEXIBAN TABLETS 10MG<br />

9600232 FLIXONASE AQUEOUS NASAL SPRAY 0.05%W/W PER MET.DOS<br />

9600230 FLIXOTIDE INHALER 125MCG<br />

9600229 FLIXOTIDE INHALER 50MCG<br />

9900265 FLIXOTIDE NEBULES INHALATION 0.5MG/2ML<br />

9900266 FLIXOTIDE NEBULES SOLUTION FOR INHALATION 2MG/2ML<br />

9900170 FLOBRIN FILM COATED TABLETS 400MG<br />

8500065 FLOGOCID CREAM<br />

9900170 FLOPRIN FILM COATED TABLETS 400MG<br />

8500399 FLORALIN TABLETS 10MG<br />

8600577 FLUANXOL DEPOT INJECTION 100MG/ML, 1ML<br />

7300044 FLUANXOL DEPOT INJECTION 20MG/ML, 1ML<br />

7300043 FLUANXOL DEPOT INJECTION 20MG/ML, 2ML<br />

7000433 FLUANXOL TABLETS 0.25MG<br />

7000431 FLUANXOL TABLETS 0.5MG<br />

7000432 FLUANXOL TABLETS 1MG<br />

9500145 FLUARIX INJECTION 15MCG/0.5ML<br />

9700185 FLUCON EYE DROPS 0.1% W/V<br />

9900586 FLUCONAZOLE CAPSULES 100MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 47<br />

Code No Product<br />

9900587 FLUCONAZOLE CAPSULES 200MG<br />

9500535 FLUCONAZOLE GOLGI CAPSULES 150MG<br />

9500321 FLUCOZAL CAPSULES 100MG<br />

9300509 FLUCOZAL CAPSULES 150MG<br />

9500114 FLUCOZAL CAPSULES 200MG<br />

9300508 FLUCOZAL CAPSULES 50MG<br />

9800242 FLUDARA VIALS 50MG<br />

8200156 FLUDEX TABLETS 2.5MG<br />

8900531 FLUIBRON SYRUP 15MG/5ML<br />

9800332 FLUMETOL A EYE DROPS<br />

9800522 FLUOCIM CAPSULES 20MG<br />

8800489 FLUOROURACIL INJECTION 25MG/ML, 10ML VIALS<br />

9900588 FLUOXETINE CAPSULES 20MG<br />

9500536 FLUOXETINE GOLGI CAPSULES 20MG<br />

8900293 FLUPHENAZINE DECANOATE INJECTION 25MG/ML, 1ML<br />

7700236 FLUROFEN SUGAR COATED TABLETS 100MG<br />

8600673 FLUROZIN SUGAR COATED TABLETS 100MG<br />

8600672 FLUROZIN SUGAR COATED TABLETS 50MG<br />

9400080 FLUSEMINAL FILM COATED TABLETS 400MG<br />

9100126 FLUTAN TABLETS 250MG<br />

9900429 FLUTAPLEX TABLETS 250MG<br />

9400432 FLUVIRIN LIQUID 15MCG/0.5ML<br />

9300507 FLUXIL CAPSULES 20MG<br />

8400534 FML-NEO EYE SUSPENSION<br />

9500192 FOLICIL TABLETS 10MG<br />

9900616 FOLIFER TABLETS<br />

9900294 FORADIL CAPSULES 12MCG<br />

9300427 FORANE LIQUID 100ML<br />

9400326 FORCEVAL CAPSULES<br />

9400327 FORCEVAL JUNIOR CAPSULES<br />

9400328 FORCEVAL PROTEIN (NATURAL, STRWBERRY, VANILLA) POWDER<br />

2000050 FORD PILLS WITH SENNA TABLETS<br />

8400305 FORTA B12 INJECTION 4MG/ML, 3ML AMPS<br />

7700185 FORTANEURIN INJECTION<br />

20F0055 FORT-E-VITE CAPSULES 1000IU<br />

91F0450 FORT-E-VITE PLUS SOFT GELATIN CAPSULES 200IU<br />

9800589 FORTOVASE SOFT GELATIN CAPSULES 200MG<br />

9500560 FOSAMAX TABLETS 10MG<br />

2000519 FOSAMAX TABLETS 70MG<br />

2000354 FOSTIMON HP INJECTION 150IU WITH SOLVENT<br />

2000353 FOSTIMON HP INJECTION 75IU WITH SOLVENT<br />

8400085 FOTOTAR CREAM 2%<br />

8900153 FRAKIDEX EYE DROPS


EN<br />

48 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

8500221 FRAKIDEX EYE OINTMENT<br />

7700131 FRUCTINES-VICHY TABLETS 120MG<br />

8500329 FRUMERON SUGAR COATED TABLETS 2.5MG<br />

8000183 FUCIDIN CREAM 2%<br />

7101392 FUCIDIN FILM COATED TABLETS 250MG<br />

9400510 FUCIDIN GEL 20MG/G<br />

9900185 FUCIDIN H CREAM<br />

7101215 FUCIDIN INTERTULL MEDICATED DRESSING<br />

8100088 FUCIDIN ORAL SUSPENSION 50MG/5ML<br />

8900563 FUCIDIN PDR FOR INJ. 500MG WITH 10ML SOLV<br />

8500437 FUCITHALMIC VISCOUS EYE DROPS 1%<br />

9700204 FUGENTIN FILM COATED TABLETS<br />

9700202 FUGENTIN POWDER FOR ORAL SUSPENSION 125+31.5MG/5ML<br />

9700203 FUGENTIN POWDER FOR ORAL SUSPENSION 250+62.5MG/5ML<br />

2000166 FUNGIDERM CREAM 1%<br />

8900346 FUNGIZID-RATIOPHARM SPRAY 1%<br />

9600339 FUNGO SOOTHING BALM CREAM 2% W/W<br />

9600340 FUNGO VAGINAL CREAM 2% W/W<br />

9800549 FUNGOTOX CREAM<br />

9100040 FUNGUSTATIN CAPSULES 100MG<br />

9000485 FUNGUSTATIN CAPSULES 150MG<br />

9000486 FUNGUSTATIN CAPSULES 50MG<br />

9000487 FUNGUSTATIN INFUSION 2MG/ML, 50ML VIALS<br />

9900612 FUNGUSTERIL CAPSULES 150MG<br />

9600508 FUROSEMID INJECTION 20MG/2ML<br />

9700051 FUROSEMID TABLETS 40MG<br />

9500091 FYBOGEL (ORANGE OR LEMON) GRANULES 3.5G<br />

9800428 GALPSEUD LINCTUS LIQUID 30MG/5ML<br />

9800429 GALPSEUD TABLETS 60MG<br />

8900714 GANTIL CAPSULES 200MG<br />

9500282 GASTROSIL DROPS 5.97MG/1ML(=17DROPS)<br />

9500281 GASTROSIL INJECTION 5MG/ML, 2ML<br />

9500280 GASTROSIL TABLETS 10MG<br />

9500092 GAVISCON LIQUID<br />

9500093 GAVISCON TABLETS<br />

9600429 GELOFUSINE INFUSION 500ML<br />

9800125 GENEFADRONE INFUSION 2MG/ML, 10ML<br />

91F0366 GENESIS TABLETS<br />

9000450 GENTAMED INJECTION 40MG/ML, 2ML<br />

8600600 GENTAMICIN INJECTION 40MG/ML, 2ML<br />

9100120 GENTAMICIN INJECTION 40MG/ML, 2ML AMP<br />

8300292 GENTAMYTREX EYE DROPS<br />

9700477 GENTANIT EYE DROPS


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 49<br />

Code No Product<br />

9700474 GENTANIT OINTMENT<br />

9900487 GENTEAL EYE DROPS 0.3MG/ML<br />

9800336 GENTIBIOPTAL EYE DROPS<br />

8400561 GENTICOL EYE DROPS 0.3%<br />

9900472 GERTALGIN CAPSULES 20MG<br />

8800599 GESTONE INJECTION 50MG/ML, 1ML<br />

8900212 GESTONE INJECTION 50MG/ML, 2ML AMP<br />

7300098 GEVRAL PROTEIN(CUSTARD, OR, CHOC., STRAWB.FL.) PDR SA<br />

8700445 GILEMAL TABLETS 5MG<br />

9900191 GINKGO BILOBA CAPSULES 60MG<br />

89F0032 GINSANA SOFT GELATIN CAPSULES 100MG<br />

89F0035 GINSANA TONIC SYRUP 46.6MG/5ML<br />

89F0034 GINSANA TONIC WITHOUT ALCOHOL SYRUP 46.6MG/5ML<br />

86F0121 GINSENG CAPSULES 400MG<br />

2000113 GINSENG TABLETS 500MG<br />

8400238 GLIBAN TABLETS 5MG<br />

8700474 GLIBENCLAMID-RATIOPHARM TABLETS 3.5MG<br />

7700141 GLIBENESE TABLETS 5MG<br />

7900220 GLIBESYN TABLETS 5MG<br />

8000592 GLITISOL TABLETS 5MG<br />

8900094 GLOPIR RETARD SUSTAINED RELEASE TABLETS 20MG<br />

8500512 GLOPIR TABLETS 10MG<br />

9500646 GLUCAGEN HYPOKIT POWDER FOR INJECTION 1MG/ML WITH 1ML SOLVENT<br />

9400047 GLUCOBAY TABLETS 100MG<br />

9400046 GLUCOBAY TABLETS 50MG<br />

9000188 GLUCOPHAGE TABLETS 500MG<br />

9000187 GLUCOPHAGE TABLETS 850MG<br />

9800508 GLUCOSE 4.3% WITH SODIUM CHLORIDE 0.18% PARENTERAL SOLUTION 50<br />

9800507 GLUCOSE 4.3% WITH SODIUM CHLORIDE 0.18% PARENTERAL SOLUTION 10<br />

9500604 GLUCOSE 5% WITH SODIUM CHLORIDE 0.9% PARENTERAL SOLUTION 1000ML<br />

9900558 GLUCOSE INFUSION 5% W/V, 100ML<br />

9900559 GLUCOSE INFUSION 5% W/V, 250ML<br />

9600355 GLUCOSE PARENTERAL SOLUTION 5% W/V, 500ML<br />

9900061 GLURENOR TABLETS 30MG<br />

9400273 GLYCERINE JOHNZ FOR CHILDREN SUPPOSITORIES 1200MG<br />

9200537 GLYCERINE MICROCLYSMA JHONZ FOR ADULTS MICROENEMA 2400MG<br />

9200536 GLYCERINE MICROCLYSMA JOHNZ FOR BABIES MICROENEMA 1800MG<br />

9400274 GLYCERINE MICROCLYSMANS JOHNZ FOR CHILDREN MICROENEMA 2100MG<br />

9400440 GLYCINE IRRIGATING SOLUTION 1.5% W/V<br />

9500544 GLYFORMIN FILM COATED TABLETS 850MG<br />

2000123 GLYSS-GO ENEMA<br />

2000183 GLYTRIN SPRAY 0.4MG


EN<br />

50 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9900375 GLYVENOL SOFT GELATIN CAPSULES 400MG<br />

2000023 GNOSTOL INJECTION 500MG/ML<br />

8100441 GOLD MEDAL MEDICATED OIL LIQUID<br />

9900523 GOLDCARE CAPSULES<br />

9600149 GONAL-F POWDER FOR INJECTION 75IU/ML<br />

9900035 GRACIAL TABLETS<br />

9500702 GRAMIDIL CAPSULES 500MG<br />

9500703 GRAMIDIL POWDER FOR ORAL SUSPENSION 250MG<br />

2100054 GRANOCYTE 34 INJECTION 33.6MIU/ML<br />

2000619 GRAVOL CHEWABLE TABLETS 15MG<br />

2000617 GRAVOL CHEWABLE TABLETS 50MG<br />

2000618 GRAVOL FILM COATED TABLETS 25MG<br />

2000616 GRAVOL LIQUID 15MG/5ML<br />

2000623 GRAVOL SUPPOSITORIES 100MG<br />

2000622 GRAVOL SUPPOSITORIES 25MG<br />

2000624 GRAVOL SUPPOSITORIES 50MG<br />

9400332 GREGODERM OINTMENT<br />

9800129 GRENOVIX SYRUP 15MG/5ML<br />

9800127 GRENOVIX SYRUP 30MG/5ML<br />

9900273 GRISAL TABLETS 125MG<br />

9900274 GRISAL TABLETS 250MG<br />

9900275 GRISAL TABLETS 500MG<br />

8100066 GRISEOFULVIN TABLETS 125MG<br />

9300376 GRISEOFULVIN TABLETS 500MG<br />

9300336 GROFENAC ENTERIC COATED TABLETS 50MG<br />

9400313 GROFENAC INJECTION 75MG/3ML AMP<br />

9400312 GROFENAC SUPPOSITORIES 100MG<br />

8700180 GYNERA SUGAR COATED TABLETS<br />

8600231 GYNIPRAL TABLETS 0.5MG<br />

8600232 GYNIPRAL-CONCENTRATE INFUSION 5MCG/ML<br />

7600451 GYNO-DAKTARIN CREAM 2%<br />

8000618 GYNO-DAKTARIN VAGINAL OVULES 200MG<br />

8400416 GYNO-DAKTARIN VAGINAL OVULES 400MG<br />

9300210 GYNOFLOR E VAGINAL TABLETS<br />

8900583 GYNOFLORAN CAPSULES 150MG<br />

8900569 GYNOFLORAN CAPSULES 50MG<br />

9800530 GYNO-PEVARYL 50 VAGINAL CREAM 1%<br />

9800576 GYNO-PEVARYL 50 VAGINAL SUPPOSITORIES 50MG<br />

9800524 GYNO-PEVARYL DEPOT VAGINAL SUPPOSITORIES 150MG<br />

9800523 GYNO-PEVARYL VAGINAL SUPPOSITORIES 150MG<br />

9100203 GYNO-TARDYFERON SUSTAINED RELEASE TABLETS<br />

8400415 GYNO-TRAVOGEN VAGINAL CREAM 1%<br />

8100314 GYNO-TRAVOGEN VAGINAL TABLETS 300MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 51<br />

Code No Product<br />

8900770 GYRABLOCK FILM COATED TABLETS 200MG<br />

2000191 HAES-STERIL INFUSION 10%<br />

2000169 HAES-STERIL INFUSION 6%+0.9%<br />

8000323 HALCION TABLETS 0.25MG<br />

8400267 HALDOL DECANOAS INJECTION 100MG/ML, 1ML AMP<br />

8400265 HALDOL DECANOAS INJECTION 50MG/ML, 1ML AMP<br />

7700020 HALDOL DROPS 2MG/ML, 15ML<br />

7700019 HALDOL INJECTION 5MG/ML, 1ML AMP<br />

7700021 HALDOL TABLETS 0.5MG<br />

8700274 HALDOL TABLETS 20MG<br />

7700023 HALDOL TABLETS 5MG<br />

9500240 HALOTHANE M & B LIQUID 100%<br />

9400491 HALOXEN TABLETS 10MG<br />

8600055 HALOXEN TABLETS 20MG<br />

92F0028 HALYCITROL SYRUP<br />

9200376 HAMETUM CREAM<br />

9900513 HARMONETTE TABLETS<br />

9300385 HAVRIX ADULTS INJECTION<br />

8700452 H-B-VAX-DNA INJECTION 10MCG/ML, 1ML<br />

8900377 H-B-VAX-DNA PAEDIATRIC INJECTION 5MCG/0.5ML VIAL<br />

9700649 HEALON GV INTRAOCULAR SOLUTION 10 MG/ML, WITH 1 ML SOLVENT<br />

9700648 HEALON INTRAOCULAR SOLUTION 10MG/ML<br />

98F0473 HEALTH AID KORGIN KOREAN GINSENG CAPSULES 250MG<br />

98F0475 HEALTH AID SIBERGIN-SIBERIAN GINSENG GR CAPSULES 2500MG<br />

98F0474 HEALTH AID SUPER VITAMIN C TABLETS 500MG<br />

9900200 HEALTHAID-BETA CAROTENE CAPSULES<br />

9900197 HEALTHAID-GERICAPS CAPSULES<br />

9900198 HEALTHAID-HAIR-VIT CAPSULES<br />

9900512 HEALTHAID-OSTEOVIT TABLETS<br />

9900201 HEALTHAID-STRONG CALCIUM TABLETS 60CMG<br />

9900203 HEALTHAID-SUPER MAGNESIUM TABLETS<br />

9900196 HEALTHAID-VITAMIN B, COMPLEX CAPSULES<br />

9900261 HEALTHAID-VITAMIN B6 TABLETS 100MG<br />

9300485 HEALTHY FEET CREAM<br />

9700449 HEMERAN GEL 10MG<br />

7100391 HEMINEVRIN CAPSULES 300MG<br />

8100090 HEPARIN INJECTION 5000IU/ML, 5ML VIAL<br />

8500079 HEPARIN-30000 — RATIOPHARM OINTMENT<br />

9300441 HEPARIN-RATIOPHARM SPORT GEL 600IU/G<br />

9900553 HERBAL OSTEO-CALMAG SPRAY<br />

84F0575 HERBALENE POWDER<br />

2000505 HERCEPTIN 150MG<br />

97F0001 HERMES MULTIVIT EFFERVESCENT TABLETS


EN<br />

52 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

99F0254 HERMES MULTIVIT TABLETS<br />

98F0254 HERMES TOPFITZ MULTIVITAMINS + MINERALS EFFERVESCENT TABLETS<br />

8900667 HERPESAN GEL 2%<br />

9600015 HERPETAD CREAM 5%<br />

9600016 HERPETAD TABLETS 200MG<br />

9600017 HERPETAD TABLETS 400MG<br />

9700547 HERVIROS S N SOLUTION<br />

9400400 HEXAPNEUMINE FOR ADULTS SYRUP<br />

9400398 HEXAPNEUMINE FOR CHILDREN SYRUP<br />

9400399 HEXAPNEUMINE FOR INFANTS SYRUP<br />

9400401 HEXASPRAY THROAT SPRAY 30G<br />

8900639 HEXETIDINE MOUTHWASH 0.1%<br />

8900220 HEXIGEL GEL 0.5%<br />

9800221 HILL'S BALSAM CHESTY COUGH FOR CHILDREN LIQUID 100MG/5ML<br />

9800208 HILL'S BALSAM CHESTY COUGH LOZENGES<br />

9800207 HILL'S BALSAM DRY COUGH LIQUID 10MG/5ML<br />

9800209 HILL'S BALSAM EXTRA STRONG 2 IN 1 LOZENGES<br />

9000423 HIRUDOID CREAM 0.3%<br />

9000418 HIRUDOID GEL 0.3%<br />

7200848 HISTALIX EXPECTORANT SYRUP<br />

7200850 HISTERGAN CREAM 2%<br />

7200851 HISTERGAN SYRUP 10MG/5ML<br />

9800486 HIVOTEX SYRUP 30MG/5ML<br />

91F0368 HONEY & MOLASSA SYRUP<br />

9900666 HORESTYL SYRUP 0.1%<br />

9800501 HUMALOG INJECTION 100IU<br />

9800553 HUMALOG INJECTION 100IU<br />

8900031 HUMATROPE PDR FOR INJ. 4IU WITH 2ML SOLVENT<br />

9000164 HUMULIN 70/30 SUSP. FOR INJ.100IU/ML, 10ML VIAL<br />

8300302 HUMULIN N (NPH) SUSP. FOR INJ.100IU/ML, 10ML VIAL<br />

8300300 HUMULIN R (REGULAR) INJECTION 100IU/ML, 10ML VIALS<br />

8900140 HYDRALAZINE HCL SUGAR COATED TABLETS 50MG<br />

8600430 HYDRALAZINE SUGAR COATED TABLETS 10MG<br />

8200428 HYDROCHLOROTHIAZIDE TABLETS 50MG<br />

7500305 HYDROCORTANCYL SUSPENSION FOR INJECTION 25MG/ML, 5ML VIAL<br />

9600548 HYDROMED POWDER FOR INJECTION 100MG<br />

9900343 HYGROTON RESERPIN TABLETS<br />

9900345 HYGROTON TABLETS 50MG<br />

9900172 HYLAFORM GEL 5.5MG/ML<br />

8400587 HYPNOMIDATE INJECTION 2MG/ML, 10ML<br />

9100288 HYTRIN STARTER PACK TABLETS 1MG + 2MG<br />

9100289 HYTRIN TABLETS 2MG<br />

9100290 HYTRIN TABLETS 5MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 53<br />

Code No Product<br />

9700135 HYZAAR TABLETS 50/12.5MG<br />

2000062 I CAPS TABLETS<br />

9300174 IALUGEN PLUS CREAM<br />

9900606 IBUHEXAL FILM COATED TABLETS 400MG<br />

9400297 IBUTAD FILM COATED TABLETS 400MG<br />

9400298 IBUTAD FILM COATED TABLETS 600MG<br />

9400299 IBUTAD S SUPPOSITORIES<br />

7700483 IDARAC TABLETS 200MG<br />

9600430 IDEOS TABLETS<br />

9700128 IDROSTAMIN FILM COATED TABLETS 400MG<br />

9700129 IDROSTAMIN INJECTION 80MG/ML, 5ML<br />

9700335 IKELAN DROPS 150MG/ML<br />

9800274 ILGEM TABLETS 200MG<br />

7201357 ILIADIN ADULT SOLUTION 0.05%<br />

7201356 ILIADIN PAEDIATRIC SOLUTION 0.025%<br />

7100230 ILOSONE POWDER FOR ORAL SUSP. 125MG/5ML<br />

94F0322 IMEDEEN TABLETS<br />

9400478 IMEX CREAM 3%<br />

9600236 IMIGRAN INJECTION 6MG IN 0.5ML SYRINGE<br />

9800189 IMIGRAN NASAL SPRAY 10MG<br />

9600237 IMIGRAN TABLETS 100MG<br />

9600475 IMIGRAN TABLETS 50MG<br />

9900540 IMIPRAMINE FILM COATED TABLETS 10MG<br />

9900541 IMIPRAMINE FILM COATED TABLETS 25MG<br />

8800359 IMIPRAMINE SUGAR COATED TABLETS 10MG<br />

7600452 IMODIUM CAPSULES 2MG<br />

9200053 IMPORTAL POWDER IN SACHET<br />

9300402 IMUKIN INJECTION 0.2MG/ML, 2ML<br />

8100245 IMURAN FILM COATED TABLETS 50MG<br />

8600320 INDERAL FILM COATED TABLETS 10MG<br />

8600322 INDERAL-LA SUSTAINED RELEASE CAPSULES 160MG<br />

8600346 INDERAL-LA SUSTAINED RELEASE CAPSULES 80MG<br />

9000425 INDERM SOLUTION 1%<br />

9300556 INDOCEM CAPSULES 25MG<br />

7900424 INDOCID RETARD SUSTAINED RELEASE CAPSULES 75MG<br />

9900461 INDOMETHACIN CAPSULES 25MG<br />

9400525 INDOMET-RATIOPHARM GEL 1%<br />

8000556 INDOREM CAPSULES 25MG<br />

8600090 INDOREM SUPPOSITORIES 100MG<br />

7700411 INDYLON CAPSULES 25MG<br />

8900425 INDYLON SUPPOSITORIES 50MG<br />

8500438 INDYLON SUSTAINED RELEASE CAPSULES 75MG


EN<br />

54 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9100275 INFACOL ORAL SUSPENSION 4%<br />

9600366 INFANRIX (DTPa) INTRAMUSCULAR INJECTION<br />

9800426 INFANRIX-HIB INJECTION<br />

2100078 INFANTOL DROPS<br />

2100079 INFANTOL LIQUID<br />

9400405 INFECTOFLAM EYE DROPS<br />

9400396 INFECTOFLAM EYE OINTMENT<br />

9000528 INHIBACE FILM COATED TABLETS 5MG<br />

9400023 INNOHEP INJECTION 10000IU/ML, 2ML VIAL<br />

9700216 INNOHEP INJECTION 20000 ANTI-XA IU/ML<br />

9400022 INNOHEP INJECTION 3500 ANTI-XAIU PER 0.35ML<br />

9700215 INNOHEP INJECTION 4500 ANTI-XA IU/0.45ML<br />

9900139 INNOHEP SYRINGE<br />

9900140 INNOHEP SYRINGE 10000 ANTI-XA IU/ML, 0.25ML SYRINGE<br />

9900137 INNOHEP SYRINGE 20000 ANTI-XA IU/ML, 0.5ML SYRINGE<br />

9900138 INNOPHEP INJECTION 20,000 ANTI/XA IUML IN 0.7ML,SYRINGES<br />

9400343 INSULATARD HM PENFILL SUSP. FOR INJ.100IU/ML, 3ML CARTR<br />

8900379 INSULATARD HM PENFILL SUSP. FOR INJ.100IU/ML,1.5ML CARTR<br />

8900380 INSULATARD HM SUSP. FOR INJ.100IU/ML, 10ML VIALS<br />

8500349 INSULIN LENTE MC SUSP. FOR INJ.100IU/ML, 10ML VIALS<br />

9600269 INVIRASE CAPSULES 200MG<br />

7700180 IODO COLLYRE EYE DROPS<br />

9700171 IOPIDINE EYE DROPS 0.5%<br />

8600073 IPOLIPID CAPSULES 300MG<br />

9200021 IPOLIPID TABLETS 600MG<br />

9500302 IPRATROPIUM STERI-NEB SOLUTION FOR INH. 250MCG/ML AMP<br />

9500303 IPRATROPIUM STERI-NEB SOLUTION FOR INH. 500MCG/2ML<br />

9600083 IPSATOL SYRUP<br />

9500137 IRCON-FA TABLETS<br />

20F0036 IRON TABLETS 50MG<br />

2000077 ISMO FILM COATED TABLETS 20MG<br />

9500735 ISOFLURANE SOLUTION FOR INHALATION 100%<br />

8200029 ISO-MACK RETARD SUSTAINED RELEASE CAPSULES 20MG<br />

8200032 ISO-MACK RETARD SUSTAINED RELEASE CAPSULES 40MG<br />

9900609 ISONIAZID.TABLETS 100MG<br />

9900608 ISONIAZID TABLETS 300MG<br />

8400719 ISOPRINOSINE SYRUP 250MG/5ML<br />

8400720 ISOPRINOSINE TABLETS 500MG<br />

7900051 ISOPTIN FILM COATED TABLETS 40MG<br />

7900052 ISOPTIN FILM COATED TABLETS 80MG<br />

7900053 ISOPTIN SUSTAINED RELEASE TABLETS 120MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 55<br />

Code No Product<br />

8800537 ISOPTIN SUSTAINED RELEASE TABLETS 240MG<br />

7700448 ISORDIL TABLETS 10MG<br />

7700449 ISORDIL TABLETS 5MG<br />

8200427 ISOREM SUBLINGUAL TABLETS 5MG<br />

8200426 ISOREM TABLETS 10MG<br />

2000178 ISOTRATE TABLETS 10MG<br />

2000179 ISOTRATE TABLETS 20MG<br />

2000180 ISOTRATE TABLETS 40MG<br />

9400402 ISOTREX GEL 0.05% W/W<br />

21F0004 JOINTACE CAPSULES<br />

8400086 K H 3 GERIATRICUM CAPSULES<br />

7900468 KALIUM DURULES SUSTAINED RELEASE TABLETS 1G<br />

8800442 KALMAX TABLETS 10MG<br />

8800441 KALMAX TABLETS 5MG<br />

9300465 KALMIREN TABLETS 10MG<br />

9300464 KALMIREN TABLETS 5MG<br />

8700183 KALTEN CAPSULES<br />

9500466 KANAMYCIN-POS EYE DROPS 0.5%<br />

8500268 KAOPECTATE CONCENTRATE SUSPENSION<br />

9400076 KAPARLON-S TABLETS 20MG<br />

7300570 KEFLEX SUSPENSION 250MG/5ML<br />

7300882 KEFLEX TABLETS 500MG<br />

7100236 KEFLIN PDR FOR INJ. 1G VIAL<br />

8100202 KEMADRIN TABLETS 5MG<br />

9000590 KENACORT-A SUSPENSION FOR INJECTION 40MG/ML, 1ML VIAL<br />

9200238 KENALOG IN ORABASE OINTMENT 0.1% W/W<br />

9500138 KENWOOD THERAPEUTIC LIQUID<br />

9500101 KERLONE FILM COATED TABLETS 20MG<br />

9800277 KETOCONAZOLE GOLGI SHAMPOO 2%<br />

8400241 KETOCONAZOLE TABLETS 200MG<br />

9900063 KETOZAL TABLETS 200MG<br />

8700265 KETROZOL TABLETS 200MG<br />

9800433 KIDDI PHARMATON FIZZ EFFERVESCENT TABLETS<br />

8800649 KIDDI PHARMATON SYRUP<br />

99F0548 KID'S MULTI SPRAY<br />

9100127 KIRIN POWDER FOR INJECTION 2G VIAL<br />

9300426 KLARICID GRANULES FOR ORAL SUSP. 125MG/5ML<br />

9200100 KLARICID TABLETS 250MG<br />

8900768 KLEAN-PREP POWDER 69G IN SACHETS<br />

9900071 KLERIMED FILM COATED TABLETS 250MG<br />

2000109 KLERIMED FILM COATED TABLETS 500MG<br />

9900629 KLERIMED GRANULES FOR ORAL SUSP. 125MG/5ML


EN<br />

56 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9900629 KLERIMED GRANULES FOR ORAL SUSPENSION 125MG/5ML<br />

9100142 KLIOGEST FILM COATED TABLETS<br />

8300490 KLONT TABLETS 250MG<br />

8400206 KLYSMOL ENEMA<br />

7100436 KONAKION CHEWABLE SUGAR COATED TABLETS 10MG<br />

7100438 KONAKION INJECTION 10MG/ML, 1ML<br />

9400545 KONAKION MM PAEDIATRIC INJECTION 2MG/0.2ML AMP<br />

8900707 KORANDIL TABLETS 10MG<br />

8900705 KORANDIL TABLETS 2.5MG<br />

8900708 KORANDIL TABLETS 20MG<br />

8900706 KORANDIL TABLETS 5MG<br />

9400374 KORYVANT CAPSULES 6MG<br />

9100437 KRATIUM INJECTION 10MG/2ML<br />

7700228 KRATIUM TABLETS 2MG<br />

7700229 KRATIUM TABLETS 5MG<br />

9400205 KYTRIL TABLETS 1MG<br />

92F0029 LABITON SYRUP<br />

8600352 LACRISIFI EYE DROPS 0.5%<br />

9000020 LACROMID FILM COATED TABLETS 200MG<br />

9800383 LACTATED RINGER'S (COOPER) INJECTION 500ML<br />

9400099 LACTATED RINGER'S PAR. SOL. 500ML<br />

9100378 LACTATED RINGER'S VIOSER PARENTERAL SOLUTION 1000ML<br />

9500048 LACTULOSE-RATIOPHARM SYRUP 66.7%<br />

9800342 LACTUMED SYRUP 100%<br />

9800342 LACTUMED SYRUP 100%<br />

9400513 LAMICTAL DISPERSIBLE TABLETS 100MG<br />

9400512 LAMICTAL DISPERSIBLE TABLETS 25MG<br />

9400511 LAMICTAL DISPERSIBLE TABLETS 5MG<br />

9900262 LAMICTAL LIQUI-TABS DISPERSIBLE TABLETS 200MG<br />

9900263 LAMICTAL LIQUITABS DISPERSIBLE TABLETS 50MG<br />

9300541 LAMICTAL TABLETS 25MG<br />

9900302 LAMISIL CREAM 1%<br />

9700123 LAMISIL SOLUTION 1%<br />

9700122 LAMISIL SPRAY 1%<br />

9900303 LAMISIL TABLETS 125MG<br />

9900301 LAMISIL TABLETS 250MG<br />

9900019 LAMOTRIX TABLETS 100MG<br />

9900017 LAMOTRIX TABLETS 200MG<br />

9900018 LAMOTRIX TABLETS 25MG<br />

9900016 LAMOTRIX TABLETS 50MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 57<br />

Code No Product<br />

20F0072 LANES CALSIUM + VITAMIN D EFFERVESCENT TABLETS<br />

20F0068 LANES IRON + VITAMIN C EFFERVESCENT TABLETS<br />

94F0259 LANES MODERN HERBAL COLD AND CATARRH SUGAR COATED TABLETS<br />

92F0542 LANES MODERN HERBAL PILE OINTMENT<br />

87F0011 LANES MODERN HERBAL PILE TABLETS<br />

94F0232 LANES MODERN HERBAL WATER RETENTION SUGAR COATED TABLETS<br />

20F0069 LANES MULTIVITAMINS + MINERALS EFFERVESCENT TABLETS<br />

20F0071 LANES VITAMIN C EFFERVESCENT TABLETS 90MG<br />

20F0070 LANES VITAMINS A+C+E ANTIOXIDANTS EFFERVESCENT TABLETS<br />

8100205 LANOXIN INJECTION 0.25MG/ML, 2ML<br />

8100249 LANOXIN-PG ELIXIR 0.05MG/ML<br />

9900589 LANSOPRAZOLE CAPSULES 15MG<br />

9900590 LANSOPRAZOLE CAPSULES 30MG<br />

9400375 LANZOR CAPSULES 30MG<br />

9700247 LANZUL CAPSULES 30MG<br />

8100545 LASIX RETARD SUSTAINED RELEASE CAPSULES 30MG<br />

9500726 LASOPROL CAPSULES 15MG<br />

9500709 LASOPROL CAPSULES 30MG<br />

9900005 LAXATIVE TEA N0.13 NATTERMANN TEA<br />

9900182 LECITONE SENIOR SOFT GELATIN CAPSULES<br />

7100929 LEDERMIX COMBINATION PACKAGE FOR DENTAL USE PASTE CEMENT & HARDENER<br />

7100928 LEDERMIX PASTE<br />

9300518 LEGOFER ORAL SOLUTION 40MGFe/15ML<br />

9900142 LEMSIP COLD + FLU BLACKCURRANT ORAL POWDER<br />

9900141 LEMSIP COLD + FLU ORIGINAL LEMON ORAL POWDER<br />

9900143 LEMSIP COUGH + COLD CHESTY COUGH MEDICINE LINCTUS 50MG/5ML<br />

9900255 LEMSIP COUGH AND COLD DRY COUGH MEDICINE SYRUP<br />

9900391 LENTARON DEPOT INJECTION 125MG/ML 2ML<br />

9900304 LEPONEX AMPOULES DRINKABLE 25MG/ML, 2ML<br />

9900305 LEPONEX TABLETS 100MG<br />

9900306 LEPONEX TABLETS 25MG<br />

9900401 LERCADIP TABLETS 10MG<br />

9900307 LESCOL CAPSULES 20MG<br />

9900308 LESCOL CAPSULES 40MG<br />

9900355 LEUCOMAX INJECTION 300MCG<br />

9900310 LEUCOMAX POWDER FOR INJECTION 0.15MG VIALS<br />

9900309 LEUCOMAX POWDER FOR INJECTION 0.4MG<br />

9900311 LEUCOMAX POWDER FOR INJECTION 0.7MG VIAL<br />

9000134 LEUCOVORIN CALCIUM INJECTION 10MG/ML, 5ML<br />

9900068 LEVOCARNIL SOLUTION 100MG/ML<br />

8800651 LEVOMED 100/10 TABLETS<br />

8800650 LEVOMED 250/25 TABLETS


EN<br />

58 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

8900191 LEVOMED TABLETS 100/25MG<br />

9900217 LEVOSYNT TABLETS<br />

9900218 LEVOSYNT TABLETS<br />

8400530 LEXILIUM TABLETS 1.5MG<br />

8400531 LEXILIUM TABLETS 3MG<br />

8600431 LEXILIUM TABLETS 6MG<br />

7400377 LEXOTANIL TABLETS 1.5MG<br />

7400378 LEXOTANIL TABLETS 3MG<br />

7400379 LEXOTANIL TABLETS 6MG<br />

2100064 LIBRAX TABLETS 5MG/2.5MG<br />

9200456 LICOFTEN SYRUP 1MG/5ML<br />

8500293 LICOFTEN TABLETS 1MG<br />

9100315 LIDOCAINE HCL 2% WITH EPINEPHRINE 1:50000 INJECTION 20MG/ML, 1.8ML CARTR<br />

9500511 LIDOCATON 2% 1:100000 INJECTION 2%, 1.8ML CARTRIDGES<br />

9500512 LIDOCATON 2% 1:80000 INJECTION 2%, 1.8ML CARTRIDGES<br />

9500609 LIDOJECT INJECTION 10MG/ML<br />

7000483 LINCOCIN CAPSULES 500MG<br />

7000484 LINCOCIN INJECTION 300MG/ML, 2ML<br />

9900210 LINDASOL SOLUTION 1%<br />

9900286 LIORESAL TABLETS 10MG<br />

9000532 LIOTON 1000 GEL 100000IU/100G<br />

9400185 LIPANTHYL 67 MICRONISED CAPSULES 67MG<br />

9400186 LIPIDIL 200 MICRONISED CAPSULES 200MG<br />

8800548 LIPOFOR CAPSULES 300MG<br />

9300480 LIPOFOR FILM COATED TABLETS 300MG<br />

9300562 LIPOFOR FILM COATED TABLETS 600MG<br />

7600434 LIPOFUNDIN S 10 PARENTERAL SOLUTION 10%, 500ML BOTTLE<br />

9100369 LIPO-MERZ RETARD SUSTAINED RELEASE CAPSULES 500MG<br />

9700200 LIPOVENOES PLR INFUSION 10%<br />

9700333 LISOLIP FILM COATED TABLETS 600MG<br />

9800345 LOBIVON TABLETS 5MG<br />

8200163 LOCABIOTAL LP SPRAY 1%<br />

9900379 LOCACORTEN CREAM<br />

9900380 LOCACORTEN TAR OINTMENT<br />

9900382 LOCACORTEN WITH NEOMYCIN CREAM<br />

9900381 LOCACORTEN WITH NEOMYCIN OINTMENT<br />

9900378 LOCACORTEN-VIOFORM EAR DROPS<br />

9900377 LOCASALEN OINTMENT<br />

9200295 LOFTYL FILM COATED TABLETS 600MG<br />

8400447 LOFTYL INJECTION 10MG/ML, 5ML<br />

9600517 LOGICIN COUGH MIXTURE CONGESTED CHESTY COUGH LIQUID<br />

9600516 LOGICIN COUGH MIXTURE FOR DRY COUGH LIQUID<br />

9600515 LOGICIN FLU STRENGTH DAY & NIGHT TABLETS


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 59<br />

Code No Product<br />

9600514 LOGICIN JUNIOR CHILDREN'S COUGH MIXTURE LIQUID<br />

9800432 LOGICIN RAPID RELIEF JUNIOR RASPBERRY FLAVOUR LOZENGES<br />

9800431 LOGICIN RAPID RELIEF ORIGINAL FLAVOUR LOZENGES<br />

9400437 LOGIMAX SUSTAINED RELEASE TABLETS<br />

9900365 LOGROTON DIVITAB SUSTAINED RELEASE TABLETS 200MG<br />

8000384 LOGYNON TABLETS<br />

9400210 LOMEXIN CREAM 2%<br />

9400213 LOMEXIN POWDER 2%<br />

9400211 LOMEXIN SPRAY 2%<br />

9400214 LOMEXIN VAGINAL CREAM 2%<br />

9400212 LOMEXIN VAGINAL OVULES 600MG<br />

9900313 LOMIR SRO SUSTAINED RELEASE CAPSULES 5MG<br />

9900312 LOMIR TABLETS 2.5MG<br />

8900785 LOMOTIL TABLETS<br />

7100976 LONARID N SUPPOSITORIES<br />

7100977 LONARID N TABLETS<br />

9700221 LONINE CAPSULES 300MG<br />

9600507 LOPERAMID-RATIOPHARM FILM COATED TABLETS 2MG<br />

9400314 LOPERAMID-RATIOPHARM SOLUTION 0.2MG/ML<br />

8200002 LOPERIUM DROPS 2MG/ML, 10ML<br />

8200001 LOPERIUM TABLETS 2MG<br />

9300429 LOPEXAL CAPSULES 2MG<br />

9500194 LOPEXAL DROPS 2MG/ML<br />

8500381 LOPID 600 FILM COATED TABLETS 600MG<br />

9900361 LOPRESOR DIVITAB SUSTAINED RELEASE TABLETS 200MG<br />

9900353 LOPRESOR FILM COATED TABLETS 100MG<br />

8900218 LORANS TABLETS 0.5MG<br />

7900221 LORANS TABLETS 1MG<br />

7900222 LORANS TABLETS 2MG<br />

9900492 LORATADINE TABLETS 10MG<br />

8000561 LORIVAN TABLETS 2MG<br />

9700205 LOSEC CAPSULES 40MG<br />

8800217 LOSEC ENTERIC COATED CAPSULES 20MG<br />

9400490 LOSEC IV INFUSION POWDER FOR INJECTION 40MG<br />

9800573 LOTORIN CUTANEOUS SOLUTION 2% W/V<br />

8600742 LOTRIDERM CREAM<br />

9600418 LOVAREM TABLETS 20MG<br />

9900462 LOVASTATIN TABLETS 10MG<br />

9900463 LOVASTATIN TABLETS 20MG<br />

9400284 LOVASTATIN TABLETS 20MG<br />

9900464 LOVASTATIN TABLETS 40MG<br />

9900280 LUDIOMIL TABLETS 10MG<br />

9900281 LUDIOMIL TABLETS 25MG<br />

8300363 LUFT TABLETS 2MG


EN<br />

60 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

8500389 LUFT TABLETS 4MG<br />

9500377 LUMAREN INJECTION 25MG/ML, 2ML<br />

9400094 LYMAN 50000 OINTMENT<br />

9500707 LYMPHOGLOBULINE INJECTION 20MG/ML, 5ML<br />

8800239 MABRON CAPSULES 50MG<br />

9800551 MABRON DROPS 100MG/ML<br />

9000403 MABRON INJECTION 50MG/ML, 2ML<br />

9800552 MABRON SUPPOSITORIES 100MG<br />

9300378 MACRODIN TABLETS 100MG<br />

9300377 MACRODIN TABLETS 50MG<br />

9400334 MAGNESIA S PELLEGRINO EFF. WITH LEMON WATER SOL. PDR 45%<br />

93F0572 MAGNESIUM TABLETS<br />

9000250 MAGNEVIST INJECTION 469MG, 20ML<br />

8800399 MAGRILAN CAPSULES 20MG<br />

2100077 MALTLEVOL-M TABLETS<br />

9000235 MALTOFER FOL CHEWABLE TABLETS<br />

7300595 MALTOFER INTRAMUSCULAR INJECTION 50MG/ML, 2ML AMP<br />

2000397 MALTOFER ORAL SOLUTION 100MG IN SINGLE DOSE<br />

8100016 MANDOL POWDER FOR INJECTION 1G VIAL<br />

8200215 MARCAINE INJECTION 5MG/ML, 20ML<br />

8700013 MARCAINE SPINAL HEAVY INJECTION 0.5%<br />

9100337 MARIPEN ORAL SUSPENSION 100MG/5ML<br />

9100338 MARIPEN TABLETS 200MG<br />

9100339 MARIPEN TABLETS 400MG<br />

9000278 MARISTON CAPSULES 300MG<br />

8300456 MARVELON TABLETS<br />

9800483 MAXALT MELT WAFERS 10MG<br />

9700182 MAXIDEX EYE DROPS 0.1% W/V<br />

9500067 MAXIPIME POWDER FOR INJECTION 1G/VIAL<br />

9500068 MAXIPIME POWDER FOR INJECTION 2G/VIAL WITH 10ML SOLVENT<br />

9700181 MAXITROL EYE DROPS<br />

9700180 MAXITROL EYE OINTMENT<br />

9400354 MAXIUS LOZENGES 5MG<br />

96F0288 MAXIVIT PLUS CAPSULES<br />

9900271 MEDAXONUM POWDER FOR INJECTION 1G<br />

9900272 MEDAXONUM POWDER FOR INJECTION 250MG<br />

9900403 MEDAXONUM POWDER FOR INJECTION 500MG<br />

95F0509 MEDIFLORA FISH OIL CAPSULES 500MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 61<br />

Code No Product<br />

9400474 MEDIJEL GEL<br />

9400473 MEDIJEL LOZENGES<br />

8600660 MEDOBETA CREAM 0.1%<br />

8600622 MEDOBETA OINTMENT 0.1%<br />

8400592 MEDOCALUM FILM COATED TABLETS<br />

8900517 MEDOCEF POWDER FOR INJECTION 1G VIAL<br />

8900518 MEDOCEF POWDER FOR INJECTION 2G<br />

8700502 MEDOCIPRIN FILM COATED TABLETS 250MG<br />

8700501 MEDOCIPRIN FILM COATED TABLETS 500MG<br />

8400621 MEDOCLAZIDE TABLETS 80MG<br />

9500593 MEDOCLOR CAPSULES 500MG<br />

9200094 MEDOCLOR FORTE POWDER FOR ORAL SUSP. 250MG/5ML<br />

9200093 MEDOCLOR POWDER FOR ORAL SUSP. 125MG/5ML<br />

7700232 MEDOCYCLINE CAPSULES 250MG<br />

8600659 MEDODERMONE CREAM 0.05%<br />

8600652 MEDODERMONE OINTMENT 0.05%<br />

8600654 MEDOFED COMPOUND SYRUP<br />

8600653 MEDOFED SYRUP<br />

9300505 MEDOFLORAN TABLETS 250MG<br />

9000519 MEDOFLOXINE FILM COATED TABLETS 200MG<br />

8900550 MEDOFLUCON CAPSULES 150MG<br />

9100135 MEDOFLUCON CAPSULES 200MG<br />

8900549 MEDOFLUCON CAPSULES 50MG<br />

7800459 MEDOFULVIN TABLETS 125MG<br />

8900217 MEDOFULVIN TABLETS 500MG<br />

9000377 MEDOGLYCIN INJECTION 300MG/ML, 2ML<br />

9000371 MEDOGLYCINE CAPSULES 250MG<br />

9000370 MEDOGLYCINE CAPSULES 500MG<br />

7900223 MEDOLAX TABLETS 12MG<br />

7900236 MEDOLEXIN CAPSULES 250MG<br />

7900237 MEDOLEXIN CAPSULES 500MG<br />

7900239 MEDOLEXIN FORTE POWDER FOR ORAL SUSP. 250MG/5ML<br />

7900238 MEDOLEXIN POWDER FOR ORAL SUSP. 125MG/5ML<br />

8400424 MEDOLIN SYRUP 2MG/5ML<br />

8100392 MEDOLIN TABLETS 2MG<br />

7700091 MEDONOL TABLETS<br />

7800464 MEDOPEN POWDER FOR ORAL SUSPENSION 125MG/5ML<br />

9000369 MEDOPEN TABLETS 250MG<br />

8900715 MEDOPHENICOL POWDER FOR INJECTION 1G VIALS<br />

8700498 MEDOPRED TABLETS 5MG<br />

9500164 MEDOQUIN TABLETS 250MG<br />

9500340 MEDORIL CAPSULES 250MG<br />

9100131 MEDORIL CAPSULES 500MG


EN<br />

62 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

8000268 MEDOSPAS CAPSULES<br />

9300504 MEDOSTATIN TABLETS 20MG<br />

8600561 MEDOTAMIFEN DS TABLETS 20MG<br />

8500533 MEDOVENT ELIXIR 15MG/5ML<br />

8700671 MEDOVENT SUSTAINED RELEASE CAPSULES 75MG<br />

9800588 MEDOVERINE FILM COATED TABLETS 135MG<br />

9400393 MEDOVIR CREAM 5% W/W<br />

9500262 MEDOVIR INJECTION 250MG<br />

9500263 MEDOVIR INJECTION 500MG<br />

8900804 MEDOVIR TABLETS 200MG<br />

9400366 MEDOVIR TABLETS 400MG<br />

9400367 MEDOVIR TABLETS 800MG<br />

7100960 MEDROL TABLETS 16MG<br />

7000495 MEDROL TABLETS 4MG<br />

9400179 MEFAC FORTE TABLETS 500MG<br />

9900106 MEFENAL CAPSULES 250MG<br />

9900107 MEFENAL CAPSULES 500MG<br />

9900627 MEGA-CAL FILM COATED TABLETS<br />

9100164 MEGACE TABLETS 160MG<br />

9900430 MEGAPLEX TABLETS 160MG<br />

9900426 MEGAPLEX TABLETS 40MG<br />

2000059 MELIANE SUGAR COATED TABLETS<br />

9900078 MELOX SUPPOSITORIES 15MG<br />

9900077 MELOX SUPPOSITORIES 7.5MG<br />

9900004 MELROSUM COUGH SYRUP N SYRUP<br />

9800557 MENCEVAX ACWY POWDER FOR INJECTION WITH SOLVENT<br />

9000003 MENINGOCOCCIQUE,VACCINE (IMOVAX) A+C PDR FOR INJ.100UG WITH 0<br />

88F0433 MENOPACE CAPSULES<br />

8500087 MENTHOLATUM BALM OINTMENT<br />

8500088 MENTHOLATUM DEEP HEAT LOTION<br />

8500086 MENTHOLATUM DEEP HEAT RUB CREAM<br />

8500089 MENTHOLATUM DEEP HEAT SPRAY<br />

8500085 MENTHOLATUM NASAL INHALER SOLUTION<br />

8900299 MEPHAMYCIN FILM COATED TABLETS 500MG<br />

8400040 MEPHAMYCIN POWDER FOR ORAL SUSP. 200MG/5ML<br />

9500513 MEPICATON INJECTION 3%, 1.8ML CARTRIDGES<br />

9100316 MEPIVACAINE HCL 3% INJECTION 3MG/ML, 1.8ML CARTR.<br />

8900424 MERCILON TABLETS<br />

9400543 MERIONAL PDR FOR INJ. 150IU WITH 2ML SOLV<br />

9100085 MERIONAL POWDER FOR INJECTION 75IU WITH 2ML DILUENT


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 63<br />

Code No Product<br />

9600584 MERONEM IV POWDER FOR INJECTION 500MG<br />

8800486 MEROPAN CAPSULES 20MG<br />

9900209 MESAGIN ENTERIC COATED TABLETS 400MG<br />

95F0209 METABOLIC PACK TABLETS<br />

8900772 METAMUCIL ORANGE POWDER 31.3%<br />

9200458 METEOSPASMYL SOFT GELATIN CAPSULES<br />

9600162 METFORAL FILM COATED TABLETS 500MG<br />

9900205 METFORAL TABLETS 850MG<br />

9900216 METFORMIN-SYNTO TABLETS 500MG<br />

9900315 METHERGINE INJECTION 0.2MG/ML<br />

9900314 METHERGINE TABLETS 0.125MG<br />

9800220 METHOCARBAMOL INJECTION 100MG/ML<br />

8500280 METHOCARBAMOL TABLETS 500MG<br />

9000133 METHOTREXATE INJECTION 2.5MG/ML, 2ML<br />

8800501 METHOTREXATE INJECTION 25MG/ML, 20ML<br />

8800503 METHOTREXATE INJECTION 25MG/ML, 2ML<br />

8000041 METHOTREXATE SODIUM PAR. PDR FOR INJ. 50MG VIAL<br />

8800500 METHOTREXATE TABLETS 2.5MG<br />

8000582 METHYLDOPA FILM COATED TABLETS 250MG<br />

9900168 METHYLDOPA FILM COATED TABLETS 500MG<br />

8900664 METOCYL SYRUP 5MG/5ML<br />

8900665 METOCYL TABLETS 10MG<br />

9400518 METRODIN HP PDR FOR INJ. 150IU AMP WITH 1ML D<br />

9400517 METRODIN HP PDR FOR INJ. 75IU AMP WITH 1ML SO<br />

9900591 METRONIDAZOLE CAPSULES 500MG<br />

9000505 METRONIDAZOLE INFUSION 5MG/ML, 100ML<br />

8200431 METRONIDAZOLE TABLETS 200MG<br />

9900592 METRONIDAZOLE TABLETS 200MG<br />

9900593 METRONIDAZOLE TABLETS 400MG<br />

9900594 METRONIDAZOLE TABLETS 500MG<br />

7900075 MEXITIL CAPSULES 200MG<br />

8700537 MG-5-LONGORAL TABLETS 1.8G<br />

9900317 MIACALCIC INJECTION 100IU/ML<br />

9900316 MIACALCIC INJECTION 50IU/ML<br />

9900319 MIACALCIC NASAL SPRAY 100IU/DOSE, 14DS(1ML)<br />

9900342 MIACALCIC NASAL SPRAY 200 IU<br />

9900318 MIACALCIC NASAL SPRAY 50IU/DOSE, 14DS(1ML)<br />

9500545 MIANSERIN HCL FILM COATED TABLETS 60MG<br />

2000187 MICANOL CREAM 1%<br />

2000186 MICANOL CREAM 3%<br />

9700241 MICOTREIS SYRUP 2%<br />

7400001 MICROGYNON SUGAR COATED TABLETS<br />

7800492 MICROLET MICROENEMA 5ML TUBES


EN<br />

64 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9300374 MICROSER DROPS 12.5MG/ML<br />

9300373 MICROSER TABLETS 8MG<br />

8100251 MIDARINE INJECTION 50MG/ML, 2ML AMP<br />

9400527 MIGRALEVE 1 FILM COATED TABLETS<br />

9400526 MIGRALEVE 2 FILM COATED TABLETS<br />

9400528 MIGRALEVE COMPLETE MIGRAINE RELIEF FILM COATED TABLETS<br />

8100208 MIGRIL TABLETS<br />

8500081 MILOREX TABLETS<br />

8600299 MILUPA GES 45 POWDER IN SACHETS<br />

20F0106 MINACID TABLETS<br />

89F0448 MINADEX ORANGE FLAVOURED TONIC LIQUID<br />

9500333 MINAKNE FILM COATED TABLETS 50MG<br />

9500206 MINAXEN CAPSULES 100MG<br />

9500205 MINAXEN CAPSULES 50MG<br />

9100390 MINIRIN NASAL SPRAY 0.1MG/ML<br />

9400487 MINIRIN TABLETS 0.1MG<br />

9400488 MINIRIN TABLETS 0.2MG<br />

7101697 MINOCIN CAPSULES 100MG<br />

9900596 MINOCYCLINE CAPSULES 100MG<br />

9900595 MINOCYCLINE CAPSULES 50MG<br />

8700266 MINOXIDIL SOLUTION 2%<br />

2000387 MIOCAMEN GRANULES FOR ORAL SUSPENSION 6G PER SACHET<br />

2000386 MIOCAMEN TABLETS 600MG<br />

8700489 MIRATON DROPS 2MG/ML<br />

8500398 MIRATON TABLETS2MG<br />

9800574 MIRENA 52MG (20MCG/24h)<br />

9400337 MIXTARD 10 HM PENFILL SUSP. FOR INJ.100IU/ML, 3ML CARTR<br />

9100045 MIXTARD 10 PENFILL SUSPENSION FOR INJECTION 100IU/ML,1.5ML CARTR<br />

9400338 MIXTARD 20 HM PENFILL SUSP. FOR INJ.100IU/ML, 3ML CARTR<br />

9100046 MIXTARD 20 PENFILL SUSPENSION FOR INJECTION 100IU/ML,1.5ML CARTR<br />

9400339 MIXTARD 30 HM PENFILL SUSP. FOR INJ.100IU/ML, 3ML CARTR<br />

8900385 MIXTARD 30 HM PENFILL SUSP. FOR INJ.100IU/ML,1.5ML CARTR<br />

8900386 MIXTARD 30 HM SUSP. FOR INJ.100IU/ML, 10ML VIALS<br />

9500651 MIXTARD 30 NOVOLET SUSPENSION FOR INJECTION 100IU/ML, 3ML CARTRI<br />

9400340 MIXTARD 40 HM PENFILL SUSP. FOR INJ.100IU/ML, 3ML CARTR<br />

9400341 MIXTARD 50 HM PENFILL SUSP. FOR INJ.100IU/ML, 3ML CARTR<br />

9600179 MOBIC SUPPOSITORIES 15MG<br />

9800450 MOBIC SUPPOSITORIES 7.5MG<br />

9600181 MOBIC TABLETS 15MG<br />

9600180 MOBIC TABLETS 7.5MG<br />

9100165 MODECATE INJECTION 25MG/ML, 1ML AMPOULE<br />

2000114 MODIODAL TABLETS 100MG<br />

7700072 MODURETIC TABLETS 50/5MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 65<br />

Code No Product<br />

2000189 MONARC-M INJECTION 250IU<br />

9700170 MONAZOLE 7 CREAM 2%<br />

9500404 MONO MACK 50D SUSTAINED RELEASE TABLETS 50MG<br />

8900318 MONO MACK DEPOT SUSTAINED RELEASE TABLETS 100MG<br />

8400559 MONO MACK TABLETS 20MG<br />

8400560 MONO MACK TABLETS 40MG<br />

9100052 MONO-B INJECTION 1000MCG/ML, 1ML<br />

7900213 MONOCLOX CAPSULES 250MG<br />

8900222 MONOCLOX POWDER FOR INJECTION 250MG<br />

8900223 MONOCLOX POWDER FOR INJECTION 500MG<br />

2000014 MONOCLOX TABLETS 250MG<br />

9100418 MONOPRIL TABLETS 20MG<br />

8900577 MONOSORDIL CAPSULES 60MG<br />

8900575 MONOSORDIL TABLETS 20MG<br />

8900384 MONOTARD HM SUSP. FOR INJ.100IU/ML, 10ML VIALS<br />

8500350 MONOTARD MC SUSP. FOR INJ.100IU/ML, 10ML VIALS<br />

7300828 MONOTEST MULTIPUNCTURE APPLICATOR INJECTION 300000IU/ML<br />

9600059 MONO-TILDIEM SUSTAINED RELEASE CAPSULES 200MG<br />

9600060 MONO-TILDIEM SUSTAINED RELEASE CAPSULES 300MG<br />

9200098 MOPEN CHEWABLE TABLETS 1G<br />

9400017 MORBILVAX INJECTION 0.5ML<br />

7800556 MOTILIUM FILM COATED TABLETS 10MG<br />

8000074 MOTILIUM ORAL SUSP. 1MG/ML<br />

8100328 MOTILIUM SUPPOSITORIES 10MG<br />

8100329 MOTILIUM SUPPOSITORIES 30MG<br />

9500422 MOUTHWASH SOLUTION EFFERVESCENT TABLETS<br />

9400481 MOVELAT GEL<br />

9600310 MOVICOL POWDER 13.8G SACHET<br />

9100333 MOVITHIOL CREAM 0.1% W/W<br />

9000615 MOXACEF CAPSULES 500MG<br />

9000612 MOXACEF POWDER FOR ORAL SUSPENSION 250MG/5ML<br />

9000614 MOXACEF POWDER FOR ORAL SUSPENSION 500MG/5ML<br />

9000613 MOXACEF TABLETS 1G<br />

8400249 MOXARIN CAPSULES 250MG<br />

8400250 MOXARIN CAPSULES 500MG<br />

8500301 MOXARIN FORTE POWDER FOR ORAL SUSPENSION 250MG/5ML<br />

8500302 MOXARIN POWDER FOR ORAL SUSPENSION 125MG/5ML<br />

8900296 MOXARIN POWDER FOR ORAL SUSPENSION 500MG/5ML<br />

9400034 MOXEN CAPSULES 250MG<br />

9400035 MOXEN CAPSULES 500MG<br />

9600127 MOXICLAV FORTE POWDER FOR ORAL SUSPENSION 312,5MG/5ML<br />

9600126 MOXICLAV POWDER FOR ORAL SUSPENSION 156.25MG/5ML


EN<br />

66 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9600071 MOXICLAV TABLETS 375MG<br />

9300078 MOXICLAV TABLETS 625MG<br />

7900241 MOXILEN CAPSULES 250MG<br />

7900242 MOXILEN CAPSULES 500MG<br />

7900243 MOXILEN FORTE POWDER FOR ORAL SUSP. 250MG/5ML<br />

9000262 MOXILEN POWDER FOR INJECTION 1G VIAL<br />

9000260 MOXILEN POWDER FOR INJECTION 250MG VIAL<br />

9000261 MOXILEN POWDER FOR INJECTION 500MG VIAL<br />

7900244 MOXILEN POWDER FOR ORAL SUSP. 125MG/5ML<br />

8900776 MOXILEN TABLETS 1G<br />

9500283 MOXILEN TABLETS 250MG<br />

8000237 MUCOFALK GRANULES 3.5G PER 5G SACHET<br />

9500047 MUCOHEXAL SYRUP 15MG/ML<br />

9000608 MUCOMYST POWDER FOR ORAL SUSPENSION 200MG/5ML<br />

8200031 MUCOPRONT CAPSULES 375MG<br />

8200030 MUCOPRONT SYRUP 250MG/5ML<br />

9300476 MUCOSOLVAN LA SUSTAINED RELEASE CAPSULES 75MG<br />

9700242 MUCOTREIS SYRUP 5%<br />

9500704 MUXOL ORAL SOLUTION<br />

9400077 MYCO-FLUSEMIDON CREAM 1%<br />

9700479 MYCO-HERMAL CREAM 1%<br />

9700480 MYCO-HERMAL SOLUTION 1%<br />

9300272 MYCORIL CREAM 1%<br />

8400363 MYCORIL SPRAY 1%<br />

9400433 MYCORIL VAGINAL CREAM 1% W/W<br />

9300479 MYCORIL VAGINAL TABLETS 100MG<br />

9400547 MYCORIL VAGINAL TABLETS 200MG<br />

9000586 MYCOSTATIN ORAL SUSPENSION 100000U/ML<br />

9500730 MYDOFLEX SUGAR COATED TABLETS 150MG<br />

9500731 MYDOFLEX SUGAR COATED TABLETS 50MG<br />

8600328 MYSOLINE TABLETS 250MG<br />

8800253 NADAMEN CAPSULES 20MG<br />

8800342 NADAMEN FILM COATED TABLETS 20MG<br />

8900461 NADOLOL TABLETS 40MG<br />

8900460 NADOLOL TABLETS 80MG<br />

9200060 NAKLOFEN ENTERIC COATED TABLETS 50MG<br />

9200062 NAKLOFEN INJECTION 75MG/ML, 3ML<br />

9200061 NAKLOFEN SUSTAINED RELEASE TABLETS 100MG<br />

9400219 NALIDIXIC ACID TABLETS 500MG<br />

9700191 NAPHCON FORTE EYE DROPS 0.1% W/W<br />

9300309 NAPROREX ENTERIC COATED TABLETS 375MG<br />

9300473 NAPROREX TABLETS 250MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 67<br />

Code No Product<br />

9300474 NAPROREX TABLETS 375MG<br />

9300475 NAPROREX TABLETS 500MG<br />

9500674 NAPROSYN EC ENTERIC COATED TABLETS 250MG<br />

9500675 NAPROSYN EC ENTERIC COATED TABLETS 500MG<br />

9900597 NAPROXEN TABLETS 250MG<br />

9900598 NAPROXEN TABLETS 500MG<br />

8500020 NARCAN INJECTION 0.4MG/ML, 1ML AMP<br />

8500019 NARCAN NEONATAL INJECTION 0.02MG/ML, 2ML<br />

2100129 NASACORT NASAL SPRAY 55MCG<br />

9300481 NASAL INHALER<br />

9900009 NASOBEC HAYFEVER NASAL SPRAY 50MCG/SPRAY<br />

99F0056 NATUREST TABLETS<br />

9100189 NAUTISOL INJECTION 12.5MG/ML, 1ML AMP<br />

7700504 NAUTISOL TABLETS 5MG<br />

7000371 NAVIDOXINE TABLETS<br />

9900321 NAVOBAN CAPSULES 5MG<br />

9900320 NAVOBAN INJECTION 5MG/5ML<br />

8700519 NEMOTAN FILM COATED TABLETS 30MG<br />

8900314 NEO RHINOVIT NASAL GEL 1%<br />

2000244 NEOCALCIT SACHETS<br />

9700332 NEOCARDON TABLETS 100MG<br />

7101552 NEO-CODION ADULTS SYRUP<br />

7101551 NEO-CODION BABIES SYRUP<br />

7101553 NEO-CODION CHILDREN SYRUP<br />

7200260 NEO-CODION SUGAR COATED TABLETS<br />

7500074 NEOCONES CONES TABLETS<br />

7000481 NEO-CORTEF EYE EAR OINTMENT<br />

9500510 NEO-LIDOCATON INJECTION 2%, 1.8ML CARTRIDGES<br />

7000494 NEO-MEDROL ACNE LOTION<br />

2000357 NEORECORMON PREFILLED SYRINGE 1000IU/0.3ML<br />

2000358 NEORECORMON PREFILLED SYRINGE 2000IU/0.3ML<br />

2000300 NEORECORMON PREFILLED SYRINGE 4000IU<br />

2000355 NEORECORMON PREFILLED SYRINGE 5000IU/0.3ML<br />

2000356 NEORECORMON PREFILLED SYRINGE 500IU/0.3ML<br />

8100209 NEOSPORIN EYE DROPS<br />

8900192 NEOSTIGMIN INJECTION 2.5MG/ML, 1ML<br />

9300448 NEOTIGASON CAPSULES 10MG<br />

9300449 NEOTIGASON CAPSULES 25MG<br />

8000153 NEOVITA SOFT GELATIN CAPSULES<br />

8200022 NERISON FORTE FATTY OINTMENT 0.3%<br />

7700049 NERISONE C CREAM<br />

7700046 NERISONE CREAM 0.1%<br />

7700047 NERISONE OINTMENT 0.1%<br />

9200169 NERITAN ENTERIC COATED TABLETS 25MG


EN<br />

68 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9200170 NERITAN ENTERIC COATED TABLETS 50MG<br />

9200171 NERITAN SUPPOSITORIES 100MG<br />

9200172 NERITAN SUSTAINED RELEASE TABLETS 100MG<br />

7100139 NEUROBION INJECTION 3ML AMPS<br />

7100138 NEUROBION SUGAR COATED TABLETS<br />

9700024 NEURONTIN CAPSULES 100MG<br />

9700025 NEURONTIN CAPSULES 300MG<br />

9700026 NEURONTIN CAPSULES 400MG<br />

8400041 NEURORUBINE FORTE TABLETS<br />

8700177 NEURORUBINE INJECTION 1ML AMPS<br />

95F0212 NEW DETOX<br />

95F0213 NEW IMMUNADE<br />

8700439 NIBELON TABLETS 50MG<br />

9500716 NIDAGYL CAPSULES 500MG<br />

9500039 NIDAGYL TABLETS 200MG<br />

9500040 NIDAGYL TABLETS 400MG<br />

9500041 NIDAGYL TABLETS 500MG<br />

8700066 NIFEDICOR SUSTAINED RELEASE TABLETS 20MG<br />

8600272 NIFEDIPINE SUSTAINED RELEASE CAPSULES 20MG<br />

8200089 NIFELAT FILM COATED TABLETS 10MG<br />

8800429 NIFELAT Q FILM COATED TABLETS 10MG<br />

8900787 NIFELAT Q FILM COATED TABLETS 5MG<br />

8800430 NIFELAT R SUSTAINED RELEASE TABLETS 20MG<br />

8100183 NIFLAMOL CAPSULES 250MG<br />

9900021 NIFLAMOL GEL 2.5%<br />

9300499 NILSTAT ORAL SUSP. 100000U/ML<br />

9900206 NIMESULENE SACHETS 100MG<br />

9300391 NIMOTOP INFUSION 0.2MG/ML,50ML BOTTLE<br />

9300390 NIMOTOP TABLETS 30MG<br />

9400070 NIPOGALIN POWDER FOR INJECTION 1500MG<br />

9400069 NIPOGALIN POWDER FOR INJECTION 750MG<br />

8000562 NITREDON TABLETS 5MG<br />

9900290 NITRODERM TTS 10 TRANSDERMAL SYSTEM 50MG (10MG/DAY)<br />

9900285 NITRODERM TTS 5 (10CM2) TRANSDERMAL SYSTEM 5MG REL IN 24H<br />

8200007 NITRO-MACK RETARD SUSTAINED RELEASE CAPSULES 2.5MG<br />

8200028 NITRO-MACK RETARD SUSTAINED RELEASE CAPSULES 5MG<br />

8600015 NIZORAL CREAM 2%<br />

8800600 NIZORAL SHAMPOO 2%<br />

8100549 NIZORAL TABLETS 200MG<br />

8100031 NOCTAMID TABLETS 1MG<br />

9000186 NOLICIN FILM COATED TABLETS 400MG<br />

8600329 NOLVADEX FILM COATED TABLETS 10MG<br />

8600330 NOLVADEX-D FILM COATED TABLETS 20MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 69<br />

Code No Product<br />

7300376 NOOTROPIL CAPSULES 400MG<br />

7900034 NOOTROPIL DRINKABLE SOLUTION 200MG/ML, 200ML<br />

7300375 NOOTROPIL INJECTION 200MG/ML, 5ML<br />

9700131 NOOTROPIL SACHETS 1200MG<br />

7900033 NOOTROPIL TABLETS 800MG<br />

8400036 NOPIL FORTE TABLETS 800/160MG<br />

8400038 NOPIL SYRUP 200/40MG IN 5ML<br />

8400037 NOPIL TABLETS 400/80MG<br />

9900617 NOPRILAM 125 POWDER FOR ORAL SUSPENSION<br />

9900618 NOPRILAM 250 POWDER FOR ORAL SUSPENSION<br />

2000019 NOPRILAM DT TABLETS<br />

9900619 NOPRILAM TABLETS<br />

7200852 NORADRAN SYRUP<br />

9100086 NORATEN FILM COATED TABLETS 50MG<br />

8500460 NORCURON PDR FOR INJ. 4MG WITH 1ML SOLV<br />

7100034 NORDIOL 21 SUGAR COATED TABLETS<br />

8900798 NORDITROPIN PDR FOR INJ. 12IU/ML,WITH 3ML SOL<br />

8900797 NORDITROPIN PDR FOR INJ. 4IU/ML WITH 1 ML DILUENT<br />

9500111 NORDITROPIN PENSET 12 PDR FOR INJ. 6IU/ML WITH SOLVENT<br />

9500112 NORDITROPIN PENSET 24 POWDER FOR INJ. 24IU WITH 2ML DILUENT<br />

2000122 NORDITROPIN SIMPLEXx INJECTION 3.3MG/ML, 1.5ML<br />

2000121 NORDITROPIN SIMPLEXx INJECTION 6.7MG/ML, 1.5ML<br />

9800278 NORFLOXACIN GOLGI TABLETS 400MG<br />

9100083 NORIMOX CAPSULES 500MG<br />

9100154 NOROSTAN TABLETS 500MG<br />

8400584 NOROXIN TABLETS 400MG<br />

9900322 NORPROLAC TABLETS 0,075MG<br />

9900323 NORPROLAC TABLETS 0.025 + 0.05MG<br />

9900324 NORPROLAC TABLETS 0.150MG<br />

7000437 NORTRILEN TABLETS 10MG<br />

7000438 NORTRILEN TABLETS 25MG<br />

8700371 NORTRILEN TABLETS 50MG<br />

8200435 NORTRIPTYLINE HCL SUGAR COATED TABLETS 10MG<br />

8200434 NORTRIPTYLINE HCL SUGAR COATED TABLETS 25MG<br />

9100161 NORVASC CAPSULES 10MG<br />

9100160 NORVASC CAPSULES 5MG<br />

9900490 NO-SPA FORET INJECTION 80MG/4ML<br />

9900491 NO-SPA FORTE TABLETS 80MG<br />

8700479 NO-SPA INJECTION 20MG/ML, 2ML<br />

8700444 NO-SPA TABLETS 40MG<br />

9800305 NOTORIUM TABLETS 3MG<br />

9400316 NOVAL EYE DROPS 0.5%<br />

8800475 NOVOFEN TABLETS 40MG


EN<br />

70 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9800447 NOVONORM TABLETS 0.5MG<br />

9800446 NOVONORM TABLETS 1MG<br />

9800448 NOVONORM TABLETS 2MG<br />

2000118 NOVORAPID INJECTION 100U/ML, 10ML<br />

2000120 NOVORAPID NOVOLET SUSPENSION FOR INJECTION 100U/ML<br />

2000119 NOVORAPID PENFILL INJECTION 100U/ML<br />

9100002 NOXYCIN CAPSULES 100MG<br />

8700017 NUBAIN INJECTION 10MG/ML, 1ML<br />

8500014 NUBAIN INJECTION 20MG/ML, 1ML<br />

7800354 NUELIN LIQUID 60MG/5ML<br />

8100043 NUELIN SA SUSTAINED RELEASE TABLETS 175MG<br />

8100044 NUELIN SA SUSTAINED RELEASE TABLETS 250MG<br />

9300558 NUGATEX TABLETS 250MG<br />

8400598 NUROFEN FILM COATED TABLETS 200MG<br />

9100277 NUROFEN FOR CHILDREN SUGAR — FREE ORAL SUSPENSION 100MG/5ML<br />

8700199 NU-SEALS 300 TABLETS 300MG<br />

9400377 NU-SEALS ENTERIC COATED TABLETS 75MG<br />

9900516 NYOLOL 0,1% GEL 1.37MG/G<br />

9600057 NYOLOL EYE DROPS 0.25%<br />

9600058 NYOLOL EYE DROPS 0.5%<br />

9700065 NYTOL TABLETS 25MG<br />

2000079 OCTAGAM INFUSION 5%, 100ML<br />

2000080 OCTAGAM INFUSION 5%, 200ML<br />

2000078 OCTAGAM INFUSION 5%, 50ML<br />

8400562 OCTILIA EYE DROPS 0.05%<br />

9300280 OCTORAX TABLETS 20MG<br />

7201462 OCULOSAN EYE DROPS<br />

9600039 OCULOTECT FLUID EYE DROPS<br />

9600040 OCULOTECT FLUID SINE EYE DROPS<br />

9700120 OCUVITE FILM COATED TABLETS<br />

9100395 OESTROGEL GEL<br />

9400162 OFF LOTION 6.65%<br />

9200241 OFLOX EYE DROPS 0.3%<br />

9900465 OFLOXACIN CAPSULES 200MG<br />

9900466 OFLOXACIN CAPSULES 400MG<br />

9500627 OFLOXACIN GOLGI TABLETS 200MG<br />

9700147 OFLOXIN TABLETS 400MG<br />

8100562 OLAMYC TINCTURE<br />

97F0075 OLBAS INHALER<br />

8900584 OLBAS OIL<br />

9800520 OLBETAM CAPSULES 250MG<br />

8600444 OLFEN DEPOCAPS SUSTAINED RELEASE CAPSULES 100MG<br />

8900298 OLFEN GEL 1%


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 71<br />

Code No Product<br />

8600443 OLFEN INJECTION 75MG IN 2ML AMPS<br />

8600445 OLFEN LACTAB TABLETS 25MG<br />

8600446 OLFEN LACTAB TABLETS 50MG<br />

8600442 OLFEN RECTOCAPS SUPPOSITORIES 100MG<br />

9800138 OLFEX BUCAL 200MCG<br />

9800137 OLFEX BUCAL EASI-BREATHE 200MCG<br />

9800139 OLFEX BUCAL INFANTIL 50MCG<br />

86F0515 OMEGA-H3 CAPSULES<br />

9700109 OMNIC CAPSULES 0.4MG<br />

9800352 OMNIPAQUE INJECTION 240MGI/ML, 50ML<br />

2000362 OMPRANYT CAPSULES 20MG<br />

9800457 OMR-IgG-AM 5% INFUSION 5G, 100ML<br />

9800458 OMR-IgG-AM 5% INFUSION 5G, 50ML<br />

9800563 OMRIXATE INJECTION 1000IU<br />

9800456 OMRIXATE POWDER FOR INJECTION 250IU/VIAL<br />

9800455 OMRIXATE POWDER FOR INJECTION 500IU/VIAL<br />

9900494 ONCOTICE POWDER FOR INJECTION 5X10CFUTICEBCG<br />

7000108 ONCOVIN PDR FOR INJ. 1MG<br />

2000031 ONE-ALPHA CAPSULES 0.5MCG<br />

9600067 OPHTHALIN STERILE SYRINGE 5MG<br />

7400276 OPINO GEL<br />

8500059 OPTREX EYE DROPS 13%<br />

8500062 OPTREX EYE LOTION 13%<br />

7100483 ORAP FORTE TABLETS 4MG<br />

9500356 ORELOX ORAL SUSPENSION 40MG/5ML<br />

9800529 ORTHO-GYNEST VAGINAL CREAM 0.01%<br />

9800528 ORTHO-GYNEST VAGINAL SUPPOSITORIES 0.5MG<br />

20F0107 ORTISAN TABLETS<br />

9000166 ORVET TABLETS<br />

9200245 OSMORAN SCALP LOTION 0.1%<br />

8600564 OSPAMOX FILM COATED TABLETS 500MG<br />

8600566 OSPAMOX GRANULES FOR ORAL SUSPENSION 250MG/5ML<br />

8600569 OSPEN 1000 FILM COATED TABLETS 1000000IU<br />

8600568 OSPEN 400 GRANULES FOR ORAL SUSPENSION 400000IU/5ML<br />

2000192 OSTAC FILM COATED TABLETS 520MG<br />

97F0196 OSTEO PACK<br />

94F0277 OSTEOCARE TABLETS<br />

9800542 OSTOPOR CAPSULES 200MG<br />

9800541 OSTOPOR CAPSULES 400MG<br />

9900488 OTALGAN EAR DROPS<br />

8100210 OTOSPORIN EAR DROPS<br />

9700442 OTRINOL CAPSULES 120MG<br />

9700446 OTRIVIN NASAL DROPS 0.05%


EN<br />

72 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9700445 OTRIVIN NASAL DROPS 0.1%<br />

9700447 OTRIVIN NASAL GEL 0.1%<br />

9700448 OTRIVIN NEBULISER NASAL SPRAY 0.1%<br />

8100035 OVA-MIT TABLETS 50MG<br />

9900223 OVAR AEROSOL 50MCG<br />

2000612 OVOL CAPSULES 180MG<br />

2000613 OVOL CHEWABLE TABLETS 160MG<br />

2000614 OVOL DROPS 40MG/ML<br />

7000458 OVRAL SUGAR COATED TABLETS<br />

9600293 OXACID CAPSULES 200MG<br />

9600294 OXACID CAPSULES 400MG<br />

9500050 OXACILLINE-MEDO CAPSULES 250MG<br />

9700006 OXIS TURBUHALER POWDER FOR INHALATION 4.5MCG/DOSE<br />

9700007 OXIS TURBUHALER POWDER FOR INHALATION 9MCG/DOSE<br />

8800296 OXISEPT SURGICAL SCRUB SOLUTION 7.5%<br />

9900560 OXOFENIL SOLUTION 2%<br />

9800476 OXSORALEN CAPSULES 10MG<br />

9800477 OXSORALEN LOTION 1%<br />

9900498 OXYCONTIN TABLETS 10MG<br />

9900499 OXYCONTIN TABLETS 20MG<br />

9900500 OXYCONTIN TABLETS 40MG<br />

9900501 OXYCONTIN TABLETS 80MG<br />

7700093 PAMECIL CAPSULES 250MG<br />

7800462 PAMECIL FORTE POWDER FOR ORAL SUSP. 250MG/5ML<br />

8900516 PAMECIL POWDER FOR INJECTION 1G VIAL<br />

8900519 PAMECIL POWDER FOR INJECTION 250MG<br />

8900224 PAMECIL POWDER FOR INJECTION 500MG VIAL<br />

9500339 PAMECIL TABLETS 250MG<br />

8700355 PAMPRIN TABLETS<br />

2000144 PANADOL COLD & FLU TABLETS<br />

9600090 PANADOL EXTRA SOLUBLE TABLETS<br />

9800444 PANADOL NIGHT TABLETS<br />

2000145 PANADOL SINUS TABLETS<br />

8400296 PANAGESIC TABLETS 30MG<br />

9400222 PANBIGEL MICROENEMA 75MG/5G TUBE<br />

9000170 PANCURONIUM BROMIDE INJECTION 2MG/ML, 2ML<br />

9500551 PANKREOFLAT SUGAR COATED TABLETS<br />

8100439 PANOXYL 10 GEL<br />

8600062 PANOXYL AQUAGEL GEL 10%<br />

8600061 PANOXYL AQUAGEL GEL 5%<br />

8100438 PANOXYL GEL 5%<br />

8600059 PANOXYL WASH LIQUID 10%<br />

9800439 PANSORAL GEL


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 73<br />

Code No Product<br />

2100039 PANTOGAR CAPSULES<br />

99F0089 PANTOTHENIC ACID TABLETS 100MG<br />

7000269 PANWARFIN TABLETS 5MG<br />

9300466 PARACEN TABLETS 500MG<br />

8400260 PARACETAMOL TABLETS 500MG<br />

9900229 PARACETAMOL TABLETS 500MG<br />

9900521 PARACETAMOL TABLETS 500MG<br />

9900599 PARACETAMOL/CODEINE PHOSPHATE TABLETS 500/10MG<br />

9300561 PARACODOL CAPSULES<br />

9400141 PARACODOL SOLUBLE TABLETS<br />

9300569 PARASETAL TABLETS 8/500MG<br />

9400252 PARCOTEN TABLETS<br />

9900546 PARIET TABLETS 10MG<br />

9900547 PARIET TABLETS 20MG<br />

9900325 PARLODEL TABLETS 2.5MG<br />

9500552 PASPERTASE SUGAR COATED TABLETS<br />

9500554 PASPERTIN FILM COATED TABLETS 10MG<br />

9200189 PECRAMOL SUSPENSION 120/5ML<br />

9600569 PEDIMAX TABLETS<br />

7800293 PENIMOX ORAL SUSP. 250MG/5ML<br />

8000538 PENODIL CAPSULES 250MG<br />

8000539 PENODIL POWDER FOR ORAL SUSPENSION 125MG/5ML<br />

8500083 PENOPEN POWDER FOR ORAL SUSPENSION 125MG/5ML<br />

8500084 PENOPEN POWDER FOR ORAL SUSPENSION 250MG/5ML<br />

9900354 PENPRESS TABLETS 6MG<br />

9700219 PENRAZOL ENTERIC COATED CAPSULES 20MG<br />

9400127 PEPCID AC TABLETS 10MG<br />

95F0508 PEPONEN CAPSULES 300MG<br />

8700264 PEPTOMET FILM COATED TABLETS 10MG<br />

8500600 PERAZODIN SUGAR COATED TABLETS 100MG<br />

8200430 PERAZODIN SUGAR COATED TABLETS 25MG<br />

8200429 PERAZODIN SUGAR COATED TABLETS 75MG<br />

8000547 PERAZONE TABLETS 0.5MG<br />

9700047 PERFECT ANTIOXIDANT TABLETS<br />

98F0005 PERFECTIL CAPSULES<br />

8500321 PERIDA 5 TABLETS 5MG<br />

7500075 PERIDONTONE PASTE<br />

7100301 PERLUTEX LEO TABLETS 5MG<br />

9800526 PEVARYL ATOMIZER SOLUTION 1%<br />

9800531 PEVARYL CREAM 1%<br />

9800527 PEVARYL LIPOSOMAL GEL 1%<br />

9800538 PEVARYL LOTION 1%<br />

9800525 PEVISONE OINTMENT


EN<br />

74 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

7500076 PHARMAETHYL SPRAY 100%<br />

7300004 PHARMATON SOFT GELATIN CAPSULES<br />

9900542 PHASOXON FILM COATED TABLETS 300MG<br />

9900639 PHENYLEPHRINE/COOPER EYE DROPS 5%<br />

9500686 PHENYTOIN INJECTION 50MG/ML, 5ML<br />

9300392 PHYSIOMYCINE CAPSULES 300MG<br />

9900543 PHYSIOTENS FILM COATED TABLETS 0.2MG<br />

9900544 PHYSIOTENS FILM COATED TABLETS 0.3MG<br />

9900545 PHYSIOTENS FILM COATED TABLETS 0.4MG<br />

9200046 PIL-FOOD CAPSULES<br />

8500039 PIRODAL TABLETS 2.5MG<br />

8400460 PIROXEN CAPSULES 10MG<br />

8800573 PIROXEN CAPSULES 20MG<br />

8900337 PIROXEN TABLETS 20MG<br />

9400027 PISTOFIL TABLETS 400MG<br />

9700602 PLATOSIN INJECTION 0.5MG/ML, 100ML<br />

9700600 PLATOSIN INJECTION 0.5MG/ML, 20ML<br />

9700601 PLATOSIN INJECTION 0.5MG/ML, 50ML<br />

9900427 PLATOSIN INJECTION 1MG/ML<br />

9900220 PLAZERON CAPSULES 20MG<br />

9200047 PLENDIL SUSTAINED RELEASE TABLETS 2.5MG<br />

9600396 PNEUMO 23 INJECTION 25MCG/SENOTYPE/DOSE OF 0.5ML<br />

8000253 PNEUMOVAX 23 INJECTION 25MCG/0.5ML VIAL<br />

9000382 POLIO SABIN ORAL DROPS 1ML(=10DS),1DS=2DROP<br />

7101271 POLIOMYELITIS VACCINE ON VERO CELLS DROPS 2DROPS=1DOSE<br />

9400019 POLIORAL SOLUTION 1 DOSE(1DS=2 DROPS)<br />

7100147 POLYBION INJECTION 2ML<br />

9000054 POLYGYNAX VAGINAL CAPSULES<br />

9400251 POLYTOPIC OINTMENT<br />

8000294 PONSTAN SYRUP 50MG/5ML<br />

8600591 PORPHYROCIN POWDER FOR ORAL SUSPENSION 125MG/5ML<br />

2100011 POSITON CREAM<br />

8400166 POVADYNE ANTISEPTIC SOLUTION 10%<br />

8400167 POVADYNE GARGLE AND MOUTHWASH SOLUTION 1%<br />

8400286 POVADYNE SURGICAL SCRUB SOLUTION 7.5%<br />

8900016 POVIDONE IODINE SOLUTION 10%<br />

95F0080 POWER CAPSULES<br />

9100062 PRAVACHOL TABLETS 20MG<br />

8700277 PRAXILENE TABLETS 200MG<br />

8500040 PRAZI FILM COATED TABLETS 600MG<br />

95F0066 PRECONCEIVE TABLETS 400MCG<br />

7000130 PREDNISOLONE DISPERSA EYE OINTMENT 2.5%<br />

8500273 PREDNISONE TABLETS 20MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 75<br />

Code No Product<br />

7300954 PREFRIN LIQUIFILM EYE DROPS 0.12%<br />

88F0432 PREGNACARE CAPSULES<br />

95F0215 PREGNANCY PACK COMBINATION PACK OF TABS AND CAPS<br />

9000189 PREGNATAL FILM COATED TABLETS<br />

8400082 PREGNYL INJECTION 5000IU WITH 1ML SOLV<br />

7700451 PREMARIN TABLETS 0.625MG<br />

7700438 PREMARIN TABLETS 1.25MG<br />

7700524 PREMARIN VAGINAL CREAM 0.625MG/G<br />

2000012 PREMELLE 2.5 SUGAR COATED TABLETS<br />

2000011 PREMELLE 5 SUGAR COATED TABLETS<br />

2000010 PREMELLE CYCLE 5 SUGAR COATED TABLETS<br />

88F0436 PREMENCE-28 CAPSULES<br />

8500132 PREMPAK-C 0.625 TABLETS<br />

8500133 PREMPAK-C 1.25 TABLETS<br />

8400564 PRENACID EYE OINTMENT 0.25%<br />

9700048 PRE-NATAL TABLETS<br />

9900136 PRENOL TABLETS 5MG<br />

9400344 PREPARATION H OINTMENT<br />

9400345 PREPARATION H SUPPOSITORIES 500MG<br />

9400031 PREPIDIL ENDOCERVICAL GEL 0.5MG<br />

9100039 PREPULSID TABLETS 10MG<br />

8900311 PREPULSID TABLETS 5MG<br />

8500431 PRIAXEN TABLETS 250MG<br />

8900079 PRIAXEN TABLETS 500MG<br />

8900038 PRIMAQUINE FILM COATED TABLETS 15MG<br />

8900037 PRIMAQUINE SUGAR COATED TABLETS 7.5MG<br />

9500506 PRIMOFENAC GEL 10MG<br />

7100836 PRIMOLUT DEPOT INJECTION 500MG/2ML AMP<br />

9500103 PRIMPERAN FOR ADULTS SUPPOSITORIES 20MG<br />

9500104 PRIMPERAN FOR CHILDREN SUPPOSITORIES 10MG<br />

9500105 PRIMPERAN INJECTION 5MG/ML, 2ML AMPS<br />

9500106 PRIMPERAN ORAL DROPS 2.6MG/ML, 100ML<br />

9500107 PRIMPERAN SYRUP 5MG/5ML<br />

9500108 PRIMPERAN TABLETS 10MG<br />

8100366 PRIODERM CREAM SHAMPOO 1%<br />

9800425 PRIORIX INJECTION SYRINGE<br />

9800430 PRIORIX INJECTION VIALS WITH 0.5ML DILUEN<br />

8600640 PROCARDIN FILM COATED TABLETS 75MG<br />

9200424 PROCEF FILM COATED TABLETS 250MG<br />

9200425 PROCEF FILM COATED TABLETS 500MG<br />

9200426 PROCEF POWDER FOR ORAL SUSPENSION 250MG/5ML<br />

8900582 PROCHLORPERAZINE MALEATE TABLETS 5MG<br />

9700450 PROCTO-GLYVENOL CREAM


EN<br />

76 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9900134 PROCTO-GLYVENOL SUPPOSITORIES<br />

7000533 PROCTOSEDYL OINTMENT<br />

7000535 PROCTOSEDYL SUPPOSITORIES<br />

9400249 PROCTOSONE OINTMENT<br />

9400250 PROCTOSONE SUPPOSITORIES<br />

8200433 PROGERON FILM COATED TABLETS 100MG<br />

9600574 PROGESTOGEL GEL<br />

7201364 PROGYLUTON SUGAR COATED TABLETS<br />

7100167 PROGYNOVA SUGAR COATED TABLETS 2MG<br />

8900503 PROLIFEN CAPSULES 50MG<br />

8100331 PROLIXAN FILM COATED TABLETS 600MG<br />

8400059 PROMAZINE SUGAR COATED TABLETS 25MG<br />

8400061 PROMAZINE SUGAR COATED TABLETS 50MG<br />

8100063 PROMETHAZINE FILM COATED TABLETS 10MG<br />

8100064 PROMETHAZINE FILM COATED TABLETS 25MG<br />

8000567 PROPANTHELINE BROMIDE SUGAR COATED TABLETS 15MG<br />

9900057 PROPECIA TABLETS 1MG<br />

98F0006 PROPEX CONCENTRATED SYRUP<br />

2000067 PROPOFOL FRESENIUM EMULSION INFUSION 1%, 100ML<br />

2000065 PROPOFOL FRESENIUS EMULSION INFUSION 1%, 20ML<br />

2000066 PROPOFOL FRESENIUS EMULSION INFUSION 1%, 50ML<br />

9200260 PROSCAR TABLETS 5MG<br />

9800302 PROSTAZOCIN TABLETS 1MG<br />

9800301 PROSTAZOCIN TABLETS 2MG<br />

9300435 PROSTIN VR SOLUTION 0.5MG/ML, 1ML<br />

8700068 PROTAMIN SULPHATE LEO INJECTION 10MG/ML, 5ML<br />

9900007 PROTHURIL TABLETS 50MG<br />

8600139 PROTOPEN FILM COATED TABLETS 200MG<br />

8600141 PROTOPEN FILM COATED TABLETS 400MG<br />

7000490 PROVERA TABLETS 5MG<br />

9700178 PROVISC INTRAOCULAR SOLUTION 1%<br />

8400297 PROXEN TABLETS 500MG<br />

8900012 PROZAC CAPSULES 20MG<br />

9000230 PULMICORT TURBUHALER POWDER FOR INHALATION 100MCG/DOSE<br />

9000231 PULMICORT TURBUHALER POWDER FOR INHALATION 200MCG/DOSE<br />

7500077 PULPOMIXINE PASTE<br />

9600489 PUREGON POWDER FOR INJECTION 50IU WITH 1ML SOLVENT<br />

9200375 PYRALVEX GEL 15G<br />

9100053 QUESTRAN POWDER FOR ORAL SUSPENSION 4G IN SACHETS<br />

9400434 QUININE SULFATE FILM COATED TABLETS 300MG<br />

8900284 QUINODERM CREAM<br />

8900285 QUINODERM LOTION GEL 5%<br />

9900<strong>227</strong> QVAR AEROSOL 100MCG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 77<br />

Code No Product<br />

9900225 QVAR AEROSOL 10MCG<br />

9900226 QVAR AEROSOL 50MCG<br />

7700102 RACESTYPTINE CORD MEDICATED DRESSING<br />

7700103 RACESTYPTINE SOLUTION<br />

9400142 RADIAN MASSAGE CREAM<br />

9400143 RADIAN-B LINIMENT<br />

9400144 RADIAN-B SPRAY<br />

8800360 RAMAXIR CAPSULES 250MG<br />

9600537 RANICUX FILM COATED TABLETS 150MG<br />

9600535 RANICUX FILM COATED TABLETS 300MG<br />

8500547 RANIPLEX FILM COATED TABLETS 150MG<br />

9400107 RANIPLEX FILM COATED TABLETS 300MG<br />

9800558 RANITIC 300 FILM COATED TABLETS 300MG<br />

2000473 RANITIDINE TABLETS 150MG<br />

2000474 RANITIDINE TABLETS 300MG<br />

9400165 RAPIFEN INJECTION 0.5MG/ML<br />

9900611 RAPOLYTE POWDER<br />

2000044 REBETOL CAPSULES 200MG<br />

9900232 RECEANT POWDER FOR INJECTION 750MG<br />

7100458 REDOXON EFFERVESCENT TABLETS 1G<br />

2000018 REFACTO POWDER FOR INJECTION 1000IU/VIAL WITH SOLVENT<br />

2000016 REFACTO POWDER FOR INJECTION 250IU/VIAL WITH SOLVENT<br />

2000017 REFACTO POWDER FOR INJECTION 500IU/VIAL WITH SOLVENT<br />

9700062 REFALIN FILM COATED TABLETS 300/150MG<br />

9200240 REFRESH ARTIFICIAL TEAR EYE DROPS<br />

8600821 REGAINE SOLUTION 2%<br />

97F0152 REGHAAR TABLETS<br />

9400379 REHIDRAT POWDER 14G<br />

20F0037 RELAX AND SLEEP HERBAL FORMULA CAPSULES<br />

9500252 REMECLOR CAPSULES 250MG<br />

9400090 REMECLOR POWDER FOR ORAL SUSP. 250MG/5ML<br />

9400089 REMECLOR POWDER FOR ORAL SUSPENSION 125MG/5ML<br />

8000569 REMEDIUM TABLETS 2MG<br />

8000570 REMEDIUM TABLETS 5MG<br />

8600089 REMEDOL SUPPOSITORIES 125MG<br />

9300502 REMEDOL SUPPOSITORIES 250MG<br />

9300503 REMEDOL SUPPOSITORIES 500MG<br />

8200229 REMEDOL SUSPENSION 120MG/5ML<br />

8900272 REMETHAN 100 R SUSTAINED RELEASE TABLETS 100MG<br />

8500386 REMETHAN ENTERIC COATED TABLETS 25MG<br />

9300273 REMETHAN GEL 1% W/W<br />

9100276 REMETHAN SUPPOSITORIES 100MG<br />

2000054 REMICADE POWDER 100MG


EN<br />

78 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

8500382 REMYCIN CAPSULES 50MG<br />

2000064 RENAX TABLETS 0.5MG<br />

9900219 RENAX TABLETS 1MG<br />

8600675 RENITEC TABLETS 10MG<br />

8600049 RENITEC TABLETS 20MG<br />

8600674 RENITEC TABLETS 5MG<br />

9300371 RENNIE RAP-EZE TABLETS<br />

9700605 RESCUVOLIN POWDER FOR INJECTION 100MG<br />

9700603 RESCUVOLIN POWDER FOR INJECTION 15MG<br />

9700604 RESCUVOLIN POWDER FOR INJECTION 50MG<br />

9700584 RESCUVOLIN TABLETS 15MG<br />

9900237 RESPIROL SYRUP 15MG/5ML<br />

9900234 RESPIROL SYRUP 30MG/5ML<br />

8400573 RESTATIN OINTMENT 100000U/G<br />

8900523 RESTATIN SUGAR COATED TABLETS 500000IU<br />

7100728 RESTROPINAL PEDIATRIC DROPS<br />

9800532 RETIN-A SOLUTION 1%<br />

8700447 RETROVIR CAPSULES 100MG<br />

9300411 RETROVIR CAPSULES 250MG<br />

9400315 RETROVIR IV INFUSION 10MG/ML, 20ML<br />

7100021 RHESUMAN BERNA INJECTION 150MCG/ML, 2ML VIAL<br />

9400458 RHINATHIOL ADULT SYRUP 250MG/5ML<br />

9400459 RHINATHIOL FOR INFANTS SYRUP 100MG/5ML<br />

9400457 RHINATHIOL PROMETHAZINE SYRUP<br />

9300491 RHINOCAP CAPSULES<br />

9900081 RHINOCORT AQUA NASAL SPRAY 32MCG/DOSE<br />

9900080 RHINOCORT AQUA NASAL SPRAY 64MCG/DOSE<br />

9600410 RHINOHEXAL NASAL SPRAY 0.1%<br />

8100570 RHINOPRONT SUSTAINED RELEASE CAPSULES<br />

8200008 RHINOPRONT SYRUP<br />

9900517 RIAMET TABLETS 20/120MG<br />

9900070 RIFAPENTINE CAPSULES 150MG<br />

8900036 RIFAREN CAPSULES 300MG<br />

8200201 RIFASYNT CAPSULES 150MG<br />

7900245 RIFASYNT CAPSULES 300MG<br />

8600665 RILCAPTON TABLETS 25MG<br />

9500601 RINGER LACTATE PARENTERAL SOLUTION 1000ML<br />

8900529 RINO CLENIL SPRAY 50MG/DOSE, 200 DOSES<br />

2000099 RINOSOL NASAL SPRAY 50MCG/DOSE<br />

7700447 RIOPAN PLUS SUSPENSION<br />

7300872 RIVOTRIL TABLETS 2MG<br />

8300410 ROACCUTANE CAPSULES 10MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 79<br />

Code No Product<br />

8300411 ROACCUTANE CAPSULES 20MG<br />

9500142 ROBAZ GEL 0.75%<br />

8200607 ROCEPHIN IM PDR FOR INJ. 1G WITH 3.5ML SOLV<br />

8200603 ROCEPHIN IM PDR FOR INJ. 500MG WITH 2ML SOLV<br />

8200608 ROCEPHIN IV PDR FOR INJ. 1G WITH 10ML SOLV<br />

9300281 ROFERON-A INJECTION 4.5MIOIU<br />

9400470 ROHYPNOL TABLETS 1MG<br />

7100462 ROMILAR EXPECTORANT SYRUP<br />

9300470 ROPRIL TABLETS 12.5MG<br />

9300472 ROPRIL TABLETS 50MG<br />

8900027 ROUVAX PDR FOR INJ. 1000TCID50,0.5MLSOLV<br />

9200030 ROWACHOL ENTERIC COATED CAPSULES<br />

9400180 ROWAPRAXIN TABLETS 10MG<br />

9200032 ROWATINEX ENTERIC COATED CAPSULES<br />

8500377 ROXITAN CAPSULES 10MG<br />

8800602 ROXITAN CAPSULES 20MG<br />

9300439 ROXITAN DISPERSIBLE TABLETS 10MG<br />

9300440 ROXITAN DISPERSIBLE TABLETS 20MG<br />

95F0503 ROYAL CONCORDE ORAL SOLUTION<br />

8900026 RUDIVAX PDR FOR INJ. WITH 0.5ML SOLVENT<br />

9500505 RUDOLAC SYRUP 3.5G/15ML<br />

8500394 RUFAN 400 FILM COATED TABLETS 400MG<br />

8300377 RUFAN FILM COATED TABLETS 200MG<br />

8700646 RULID FILM COATED TABLETS 150MG<br />

9500361 RULID TABLETS 300MG<br />

9200298 RUNDE LOTION<br />

8200246 RUPAN FILM COATED TABLETS 400MG<br />

9200249 RUVOMINOX GEL 1%<br />

9900604 RYE GEL 1%<br />

9900603 RYE SOLUTION 1%<br />

7201397 RYTHMODAN CAPSULES 100MG<br />

8200063 RYTHMODAN RETARD SUSTAINED RELEASE TABLETS 250MG<br />

9400006 RYTHMOGASTRYL CAPSULES 20MG<br />

7800452 RYTMONORM FILM COATED TABLETS 150MG<br />

7800453 RYTMONORM FILM COATED TABLETS 300MG<br />

9600068 SABRIL FILM COATED TABLETS 500MG<br />

8900651 SAIZEN PDR FOR INJ. 4IU WITH 1ML SOLVENT<br />

9900012 SAIZEN POWDER FOR INJECTION 24IU(8MG) WITH DILUENT (CARTRIDGE)<br />

8800031 SALOFALK ENEMA 4G/60G<br />

9000198 SALOFALK ENTERIC COATED TABLETS 500MG<br />

9000199 SALOFALK SUPPOSITORIES 500MG<br />

9600021 SALOMOL EASI-BREATHE INHALER 100MCG/DOSE<br />

9100077 SALOMOL INHALER 100MCG/DOSE


EN<br />

80 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9100076 SALOMOL SYRUP 2MG/5ML<br />

9800521 SALOSPIR-A ENTERIC COATED TABLETS 325MG<br />

8000551 SALUREX TABLETS 40MG<br />

94F0148 SANATOGEN MULTIVITAMINS FILM COATED TABLETS<br />

94F0150 SANATOGEN MULTIVITAMINS PLUS CALCIUM TABLETS<br />

94F0149 SANATOGEN MULTIVITAMINS PLUS IRON TABLETS<br />

94F0151 SANATOGEN VITAMIN B COMPLEX FILM COATED TABLETS<br />

94F0153 SANATOGEN VITAMIN C TABLETS 500MG<br />

94F0152 SANATOGEN VITAMIN E CAPSULES 400IU<br />

9900335 SANDIMMUN CONCENTRATE INFUSION 50MG/ML, 5ML<br />

9900326 SANDIMMUN NEORAL CAPSULES 100MG<br />

9900328 SANDIMMUN NEORAL CAPSULES 50MG<br />

9900329 SANDIMMUN NEORAL ORAL SOLUTION 100MG/ML<br />

9900327 SANDIMMUN NEORAL SOFT GELATIN CAPSULES 25MG<br />

9900332 SANDOGLOBULIN INJECTION 6G WITH 200ML SOLV<br />

9900330 SANDOGLOBULIN POWDER FOR INJECTION 1G WITH 200ML SOLV<br />

9900331 SANDOGLOBULIN POWDER FOR INJECTION 3G WITH 100ML SOLV<br />

9900334 SANDOSTATIN INJECTION 0,1MG/ML<br />

9900333 SANDOSTATIN INJECTION 0.05MG/ML<br />

9400220 SARGENOR CHEWABLE TABLETS 1G<br />

9400221 SARGENOR DRINKABLE SOLUTION 5ML<br />

7500010 SAROTEN SUSTAINED RELEASE CAPSULES 25MG<br />

7500011 SAROTEN SUSTAINED RELEASE CAPSULES 50MG<br />

7000444 SAROTEN TABLETS 10MG<br />

7000445 SAROTEN TABLETS 25MG<br />

7300908 SAVENTRINE SUSTAINED RELEASE TABLETS 30MG<br />

9800467 SEDACORON INJECTION 50MG/ML, 3ML<br />

9800466 SEDACOROTST TABLETS 200MG<br />

8600129 SELAMIN MOUTHWASH 0.1%<br />

9900204 SELECIM TABLETS 5MG<br />

9200022 SELEGOS TABLETS 5MG<br />

9100171 SELEMYCIN INJECTION 250MG/ML, 2ML VIALS<br />

95F0223 SELENIUM TABLETS 50MCG<br />

7600530 SEMAP TABLETS 20MG<br />

9000173 SEMPREX CAPSULES 8MG<br />

8300376 SENNA TABLETS 7.5MG<br />

9500095 SENOKOT TABLETS 7.5MG<br />

7300092 SEPTOBORE DROPS 0.1%<br />

7500078 SEPTOMIXINE FORTE PASTE<br />

8100254 SEPTRIN DS TABLETS 800/160MG<br />

8100214 SEPTRIN TABLETS 400/80MG<br />

9900111 SERESIS SOFT GELATIN CAPSULES<br />

9900468 SERETIDE DISKS 50/100MCG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 81<br />

Code No Product<br />

9900469 SERETIDE DISKS 50/250MCG<br />

9900470 SERETIDE DISKS 50/500MCG<br />

9600464 SEREVENT DISKU 50MCG PER DISKHALER<br />

9600238 SEREVENT INHALER 25MCG METERED DOSE<br />

9100185 SEROPRAM TABLETS 20MG<br />

9800562 SETLERS ANTACID-PEPPERMINT TABLETS 500MG<br />

9800561 SETLERS ANTACID-SPEARMINT TABLETS 500MG<br />

9900024 SETLERS WIND-EZE CHEWABLE TABLETS 125MG<br />

9900050 SEVORANE LIQUID 100% V/V<br />

8800576 SIBELIUM CAPSULES 5MG<br />

9500467 SICCAPROTECT EYE DROPS<br />

9900364 SICORTEN CREAM 0,05%<br />

9900362 SICORTEN OINTMENT 0.05%<br />

9900363 SICORTEN PLUS CREAM<br />

9000238 SIFICROM EYE DROPS 4%<br />

9800579 SIFROL TABLETS 0.088MG<br />

9800580 SIFROL TABLETS 0.18MG<br />

9800581 SIFROL TABLETS 0.7MG<br />

8100488 SIGADOXIN CAPSULES 100MG<br />

8100012 SIGAPRIM FORTE TABLETS 800/160MG<br />

9400111 SILOMAT SYRUP 20MG/5ML<br />

9800247 SIMULECT INJECTION 20MG/VIAL<br />

9000599 SINEMET CR SUSTAINED RELEASE TABLETS 200/50<br />

9400083 SINEMET CR TABLETS 100/25 MG<br />

9100402 SKINOREN CREAM 20% W/W<br />

9900287 SLOW TRASITENSIN DIVITABS SUSTAINED RELEASE TABLETS<br />

7900225 SNIP TABLETS<br />

9300483 SNUFFLE BABE CHEST RUB OINTMENT<br />

9400102 SODIUM CHLORIDE 0.18% + DEXTROSE 4.3% PAR. SOL. 500ML<br />

9100377 SODIUM CHLORIDE 0.18% + DEXTROSE 4.3% PARENTERAL SOLUTION 1000ML<br />

9100381 SODIUM CHLORIDE 0.9% + DEXTROSE 5% PARENTERAL SOLUTION 1000ML<br />

9400101 SODIUM CHLORIDE 0.9% IV INFUSION PAR. SOL. 500ML<br />

9100380 SODIUM CHLORIDE 0.9% IV INFUSION PARENTERAL SOL. 0.9%, 1000ML<br />

9200349 SODIUM CHLORIDE 0.9% PARENTERAL SOLUTION 250ML<br />

8400672 SODIUM CHLORIDE 0.9% W/V IRRIGATING SOLUTION 0.9%<br />

9800379 SODIUM CHLORIDE AND DEXTROSE (COOPER) INJECTION 0.18% + 4%, 10<br />

9800378 SODIUM CHLORIDE AND DEXTROSE (COOPER) INJECTION 0.18% + 4%, 50<br />

9900557 SODIUM CHLORIDE INFUSION 0.9%, 100ML<br />

9900556 SODIUM CHLORIDE INFUSION 0.9%, 250ML<br />

9500603 SODIUM CHLORIDE PARENTERAL SOLUTION 0.9%, 1000ML<br />

9600357 SODIUM CHLORIDE PARENTERAL SOLUTION 0.9%, 500ML<br />

7000537 SOFRADEX EYE EAR DROPS<br />

7000536 SOFRADEX EYE EAR OINTMENT


EN<br />

82 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

7000539 SOFRAMYCIN EYE DROPS 0.5%<br />

7000540 SOFRAMYCIN EYE OINTMENT 0.5%<br />

7000538 SOFRAMYCIN SKIN OINTMENT<br />

7000542 SOFRA-TULLE MEDICATED DRESSING 1%<br />

9800559 SOLDESAM POMATA CREAM 0.2%<br />

9600133 SOLMUCOL FOR ADULTS SYRUP 2%<br />

8100141 SOLU-CORTEF MIX-O-VIAL INJECTION 125MG/ML, 2ML VIAL<br />

8100142 SOLU-CORTEF MIX-O-VIAL INJECTION 125MG/ML, 4ML VIAL<br />

7000498 SOLU-CORTEF MIX-O-VIAL INJECTION 50MG/ML, 2ML VIAL<br />

9900664 SOLUDAMIN ORAL SOLUTION 100MG/ML<br />

7100959 SOLU-MEDROL MIX-O-VIAL INJECTION 40MG/ML, 1ML<br />

8100143 SOLU-MEDROL MIX-O-VIAL INJECTION 62.5MG/ML, 2ML VIAL<br />

8100144 SOLU-MEDROL MIX-O-VIAL INJECTION 62.5MG/ML, 8ML VIAL<br />

9400494 SOLU-MEDROL PDR FOR INJ. 1000MG<br />

9200163 SOLVOLAN SYRUP 15MG/5ML<br />

9900630 SOMATOSTATIN-UCB POWDER FOR INJECTION 3MG WITH SOLVENT<br />

9900631 SOMATOSTATIN-USB POWDER FOR INJECTION 250MCG WITH SOLVENT<br />

9900515 SONATA CAPSULES 10MG<br />

9900514 SONATA CAPSULES 5MG<br />

9500639 SOOV BITE GEL 3% W/W<br />

9600341 SOOV CREAM 1% W/W<br />

2000098 SOTALOL HCL TABLETS 80MG<br />

2000104 SOTAX TABLETS 80MG<br />

9000277 SOTILEN GEL 1%<br />

9500616 SPASVERIN FILM COATED TABLETS 135MG<br />

9900006 SPECILID TABLETS<br />

7000134 SPERSACET C EYE DROPS<br />

7000133 SPERSADEX COMP EYE DROPS<br />

7300132 SPERSALLERG EYE DROPS<br />

7700004 SPERSANICOL EYE OINTMENT 1%<br />

8100036 SPIROLON FILM COATED TABLETS 25MG<br />

9200452 SPIROPENT ELIXIR 5MCG/5ML<br />

9900473 SPIROSINE POWDER FOR INJECTION 1000MG<br />

8900116 SPORAL CAPSULES 100MG<br />

8000322 SPORINEX TABLETS 500MG<br />

9900435 STAMIN FILM COATED TABLETS 800MG<br />

8200340 STAPHYLEXIN CAPSULES 250MG<br />

9800222 STAPHYLEXIN INJECTION 1G<br />

9800224 STAPHYLEXIN INJECTION 500MG<br />

2000344 STARLIX FILM COATED TABLETS 120MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 83<br />

Code No Product<br />

2000345 STARLIX FILM COATED TABLETS 60MG<br />

9800306 STEDON TABLETS 10MG<br />

9800308 STEDON TABLETS 2MG<br />

9800307 STEDON TABLETS 5MG<br />

9000337 STELAZINE FILM COATED TABLETS 1MG<br />

9000339 STELAZINE FILM COATED TABLETS 5MG<br />

9000340 STELAZINE SPANSULES SUSTAINED RELEASE CAPSULES 10MG<br />

9000341 STELAZINE SPANSULES SUSTAINED RELEASE CAPSULES 15MG<br />

9000338 STELAZINE SPANSULES SUSTAINED RELEASE CAPSULES 2MG<br />

8000566 STEREMAL TABLETS 5MG<br />

8400673 STERILE WATER FOR IRRIGATION IRRIGATING SOLUTION<br />

9600025 STERI-NEB SALAMOL NEBULIZING SOLUTION FOR INHALATION 2.5MG<br />

9300571 STERI-NEB SALAMOL SOLUTION FOR INHALATION 5MG/2.5ML<br />

9300570 STERI-NEB SALINE SOLUTION 0.9% W/V<br />

8400400 STESOLID INJECTION 5MG/ML, 2ML<br />

8400405 STESOLID MICROENEMA 2MG/ML, 2.5ML TUBES<br />

8400406 STESOLID MICROENEMA 4MG/ML, 2.5ML TUBES<br />

8400402 STESOLID TABLETS 2MG<br />

8400403 STESOLID TABLETS 5MG<br />

8900260 STIEMYCIN SOLUTION 2%<br />

8900492 STIEVAA CREAM 0.025%<br />

8900493 STIEVAA FORTE CREAM 0.1%<br />

8900495 STIEVAA GEL 0.025%<br />

8900494 STIEVAA GEL 0.05%<br />

9400079 STOPAREN IM POWDER FOR INJECTION 1G WITH DILUENT<br />

9400078 STOPAREN IV POWDER FOR INJECTION 1G<br />

9300548 STORILAT R FILM COATED TABLETS 400MG<br />

8200432 STORILAT TABLETS 200MG<br />

9600303 STREPSILS PAIN RELIEF PLUS LOZENGES<br />

8500259 STREPSILS WITH VITAMIN C LOZENGES<br />

9500342 STRESS FORMULA PLUS IRON TABLETS<br />

9500341 STRESS FORMULA PLUS ZINC TABLETS<br />

9700050 STRESS FORMULA/IRON TABLETS<br />

2000026 STRESSEASE TABLETS<br />

7900403 STRESSTABS 600 FILM COATED TABLETS<br />

7900405 STRESSTABS 600 WITH ZINC FILM COATED TABLETS<br />

8800492 STRONG STERILE CO-TRIMOXAZOLE IV INJ. 400/80MG IN 5ML AMP.<br />

7300002 SUDAFED ELIXIR 30MG/5ML<br />

8400686 SUDAFED EXPECTORANT SYRUP<br />

7300003 SUDAFED FILM COATED TABLETS 60MG<br />

8500476 SUDAFED-CO TABLETS<br />

9400167 SUFENTA FORTE INJECTION 0.05MG/ML, 5ML<br />

9400166 SUFENTA INJECTION 0.005MG/ML, 2ML


EN<br />

84 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9600082 SULPHO-LAC ACNE MEDICATION CREAM<br />

8500297 SULPIREN TABLETS 200MG<br />

7900224 SULPIREN TABLETS 50MG<br />

9900149 SULTRIN VAGINAL CREAM<br />

9500345 SUNVITE WITH BETA CAROTENE TABLETS<br />

95F0224 SUPER B6 TABLETS<br />

95F0222 SUPER C 1000 TABLETS<br />

95F0210 SUPER MOUSE CHILDREN'S CHEWABLE TABLETS<br />

9900502 SUPER STRENGTH PURE ENERGY TABLETS 800MG<br />

9300522 SUPERACE TABLETS<br />

9900181 SUPPLEMAMAN SOFT GELATIN CAPSULES<br />

9900253 SUPRAAVIT-MULTIVITAMIN EFFERVESCENT TABLETS<br />

9600565 SUPRAVIRAN CREAM<br />

9600566 SUPRAVIRAN TABLETS 400MG<br />

9900252 SUPRAVIT ACTIVE TABLETS<br />

9900493 SUPRAVIT-C TABLETS 1000MG<br />

8500105 SUPREFACT INJECTION 1MG/ML, 7ML<br />

8500106 SUPREFACT SPRAY 0.1MG/DOSE, 100DOSES<br />

8900722 SURGAM SA SUSTAINED RELEASE CAPSULES 300MG<br />

8600484 SURGAM TABLETS 300MG<br />

2000093 SURVANTA INTRATRACHEAL SUSPENSION 25MG/ML<br />

2000173 SYNALAR CREAM 0.025% W/W<br />

2000176 SYNALAR GEL 0.025%<br />

2000181 SYNALAR OINTMENT 0.025% W/W<br />

2000175 SYNALAR-C CREAM<br />

2000182 SYNALAR-C OINTMENT<br />

2000174 SYNALAR-N CREAM<br />

2000177 SYNALAR-N OINTMENT<br />

9600560 SYNTO-CETIRIL FILM COATED TABLETS 10MG<br />

8400242 SYNTOCIL CAPSULES 250MG<br />

8500323 SYNTOCIL CAPSULES 500MG<br />

9100193 SYNTOCIL POWDER FOR INJECTION 1G VIAL<br />

8400337 SYNTOCIL POWDER FOR ORAL SUSPENSION 125MG/5ML<br />

8400338 SYNTOCIL POWDER FOR ORAL SUSPENSION 250MG/5ML<br />

9900336 SYNTOCINON INJECTION 10 IU/1ML<br />

8400459 SYNTOCLOX CAPSULES 250MG<br />

8700499 SYNTOFLOX FILM COATED TABLETS 250MG<br />

8700500 SYNTOFLOX FILM COATED TABLETS 500MG<br />

8500393 SYNTOLAX 12 TABLETS 12MG<br />

8400243 SYNTOLEXIN CAPSULES 250MG<br />

8400245 SYNTOLEXIN CAPSULES 500MG<br />

8400340 SYNTOLEXIN FORTE POWDER FOR ORAL SUSP. 250MG/5ML<br />

8400339 SYNTOLEXIN POWDER FOR ORAL SUSPENSION 125MG/5ML


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 85<br />

Code No Product<br />

8700508 SYNTOMYCIN CAPSULES 250MG<br />

8500320 SYNTOMYCIN FILM COATED TABLETS 250MG<br />

8300361 SYNTONOL 40 TABLETS 40MG<br />

8900229 SYNTONOL TABLETS 80MG<br />

8600635 SYNTOPINE TABLETS 200MG<br />

8400240 SYNTOREN CAPSULES 150MG<br />

8500305 SYNTOREN CAPSULES 300MG<br />

8500401 SYNTOVENT TABLETS 2.5MG<br />

8400244 SYNTO-VERA FILM COATED TABLETS 40MG<br />

8400246 SYNTO-VERA FILM COATED TABLETS 80MG<br />

9900418 SYNTOVIR TABLETS 800MG<br />

9100194 SYNTOXIME POWDER FOR INJECTION 1G VIAL<br />

8400314 SYNTOZAL CAPSULES 200MG<br />

8600100 TABRIN FILM COATED TABLETS 200MG<br />

9000284 TABRIN IV INFUSION 2MG/ML,100ML BOTTLES<br />

9000414 TAGAMET INJECTION 100MG/ML, 2ML<br />

9000342 TAGAMET TABLETS 200MG<br />

9000343 TAGAMET TABLETS 400MG<br />

8400239 TAKS ENTERIC COATED TABLETS 25MG<br />

9900054 TAKS SUPPOSITORIES 100MG<br />

9900055 TAKS SUPPOSITORIES 50MG<br />

8800562 TALVOSILEN FOR ADULTS SUPPOSITORIES<br />

8800561 TALVOSILEN FOR SCHOOL CHILDREN SUPPOSITORIES<br />

8800560 TALVOSILEN FOR SMALL CHILDREN SUPPOSITORIES<br />

8900445 TALVOSILEN FORTE CAPSULES<br />

8900446 TALVOSILEN FORTE SUPPOSITORIES<br />

8800563 TALVOSILEN SYRUP<br />

8800564 TALVOSILEN TABLETS<br />

8600450 TAMAGON TABLETS 60MG<br />

8400072 TAMBOCOR TABLETS 100MG<br />

8200297 TAMIFEN TABLETS 10MG<br />

9700585 TAMOPLEX TABLETS 10MG<br />

9700587 TAMOPLEX TABLETS 20MG<br />

8900<strong>227</strong> TAMOXIFEN TABLETS 10MG<br />

9400183 TAMOXIFEN-EBEWE TABLETS 10MG<br />

8100400 TARDYFERON SUSTAINED RELEASE TABLETS 256.3MG (80MG Fe)<br />

9800485 TARGOCID POWDER FOR INJECTION 200MG WITH SOLVENT<br />

9800484 TARGOCID POWDER FOR INJECTION 400MG WITH SOLVENT<br />

7300776 TARONTAL INJECTION 20MG/ML, 5ML AMP<br />

7900199 TARONTAL SUGAR COATED TABLETS 400MG<br />

7900214 TAVER TABLETS 200MG<br />

9300282 TAXOL (CONCENTRATE) INJECTION 6MG/ML, 5ML<br />

2100126 TAXOTERE POWDER FOR RECONSTITUTION 20MG WITH 1.5ML SOLVENT


EN<br />

86 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

2100127 TAXOTERE POWDER FOR RECONSTITUTION 80MG WITH 6ML SOLVENT<br />

9100427 TEA TREE & WHICH HAZEL CREAM<br />

9700177 TEARS NATURALE II EYE DROPS<br />

9900368 TEGRETOL CR SUSTAINED RELEASE TABLETS 200MG<br />

9900367 TEGRETOL CR SUSTAINED RELEASE TABLETS 400MG<br />

9900366 TEGRETOL SYRUP 100MG/5ML<br />

9900344 TEGRETOL TABLETS 200MG<br />

9800038 TELFAST TABLETS 180MG<br />

2000042 TEMODAL CAPSULES 100MG<br />

2000041 TEMODAL CAPSULES 20MG<br />

2000043 TEMODAL CAPSULES 250MG<br />

2000040 TEMODAL CAPSULES 5MG<br />

8600642 TENEREL SYRUP 0.2MG/ML<br />

8600338 TENORETIC FILM COATED TABLETS<br />

8600339 TENORMIN INJECTION 0.5MG/ML, 10ML AMP<br />

8600341 TENORMIN TABLETS 100MG<br />

9400182 TENORMIN TABLETS 25MG<br />

8600340 TENORMIN TABLETS 50MG<br />

8800440 TENOXICAM CAPSULES 20MG<br />

8800439 TENOXICAM FILM COATED TABLETS 20MG<br />

9800082 TERSEN CAPSULES 15MG<br />

9400283 TERSEN CAPSULES 30MG<br />

8800511 TETAVAX INJECTION 40IU/0.5ML,0.5ML SYR<br />

9100240 TETESEPT THROAT FORTE LOZENGES<br />

8000446 TETRACAINE HCL EYE DROPS 0.5%<br />

9500057 TETRACT-HIB SUSP. FOR INJECTION<br />

8000572 TETRACYCLINE HCL CAPSULES 250MG<br />

9400037 TETRACYCLINE HCL CAPSULES 250MG<br />

2000443 TEVETEN TABLETS 600MG<br />

97F0197 THE MENOPAUSE PACK SACHETS<br />

8200437 THELMOX CHEWABLE TABLETS 100MG<br />

9000291 THEO-DUR SUSTAINED RELEASE TABLETS 200MG<br />

9000292 THEO-DUR SUSTAINED RELEASE TABLETS 300MG<br />

9400257 THERMO-RHEUMON CREAM<br />

8600368 THIOPENTAL LENTIA POWDER FOR INJECTION 1G IN 20ML VIALS<br />

8900515 THIORIDAZINE FILM COATED TABLETS 25MG<br />

8400070 THIORIDAZINE SUGAR COATED TABLETS 100MG<br />

8400064 THIORIDAZINE SUGAR COATED TABLETS 10MG<br />

9500629 THIORIDAZINE SYRUP 25MG/5ML<br />

9300424 TIABENDAZOLE TABLETS 500MG<br />

8500645 TIADEN TABLETS<br />

9500109 TIAPRIDAL TABLETS 100MG<br />

9900492 TICEVIS TABLETS 10MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 87<br />

Code No Product<br />

2000525 TICLID FILM COATED TABLETS 250MG<br />

9400113 TIENAM I M INJECTION<br />

9300433 TIGER BALM RED OINTMENT<br />

9300434 TIGER BALM WHITE OINTMENT<br />

9500110 TILDIEM TABLETS 60MG<br />

87F0369 TIME RELEASE STRESS B WITH C TABLETS<br />

8700207 TIMENTIN POWDER FOR INJECTION 3.2G VIALS<br />

9300306 TIMET TABLETS 200MG<br />

9300307 TIMET TABLETS 400MG<br />

2000462 TIMOLOL EYE DROPS 0.5% W/V<br />

9500364 TIMONIL RETARD SUSTAINED RELEASE TABLETS 300MG<br />

7900017 TIMOPTOL EYE DROPS 0.25%<br />

7900018 TIMOPTOL EYE DROPS 0.5%<br />

7201314 TINADERM SOLUTION 1%<br />

8500304 TINI TABLETS 500MG<br />

9400301 TMS FOR CHILDREN ORAL SUSPENSION 200/40MG PER 5ML<br />

9400300 TMS FORTE TABLETS 800/160MG<br />

9800449 TOBRABACT EYE DROPS 3MG/ML<br />

9700176 TOBRADEX EYE OINTMENT<br />

9700172 TOBRADEX EYE SUSPENSION<br />

9500688 TOBRAMYCIN INJECTION 40MG/ML, 2ML<br />

9700175 TOBREX EYE DROPS 0.3% W/V<br />

9700174 TOBREX EYE OINTMENT 0.3% W/W<br />

9900346 TOFRANIL SUGAR COATED TABLETS 10MG<br />

9900347 TOFRANIL SUGAR COATED TABLETS 25MG<br />

7100964 TOGAMYCIN POWDER FOR INJECTION 2G WITH DILUENT<br />

8800621 TOLBUTAMIDE TABLETS 500MG<br />

2000084 TOLEXINE TABLETS 100MG<br />

2000083 TOLEXINE TABLETS 50MG<br />

8900042 TOLNAFTATE SOLUTION<br />

9000459 TONOCALCIN INJECTION 100IU<br />

9300482 TOOTHACHE TINCTURE<br />

86F0266 TOP C TABLETS 200MG<br />

9800590 TOPAMAX TABLETS 100MG<br />

9800593 TOPAMAX TABLETS 200MG<br />

9800592 TOPAMAX TABLETS 25MG<br />

9800591 TOPAMAX TABLETS 50MG<br />

9500424 TOPEX TOPICAL ANESTHETIC GEL 20%<br />

7100679 TOPICORTE SKIN CREAM 0.25%<br />

9400403 TOPISONE CREAM 0.05%<br />

9400404 TOPISONE OINTMENT 0.05%<br />

8200081 TRACHITOL LOZENGES<br />

8400121 TRACRIUM INJECTION 10MG/ML, 2.5ML AMPS


EN<br />

88 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

8500554 TRACRIUM INJECTION 10MG/ML, 5ML AMPS<br />

2000417 TRAMADEX CAPSULES 50MG<br />

8600516 TRAMAL CAPSULES 50MG<br />

8600517 TRAMAL DROPS 100MG/ML(=40 DROPS)<br />

8600519 TRAMAL INJECTION 50MG/ML, 2ML<br />

9600562 TRAMAL RETARD TABLETS 100MG<br />

8600520 TRAMAL SUPPOSITORIES 100MG<br />

9600144 TRAMUNDIN RETARD SUSTAINED RELEASE TABLETS 100MG<br />

9300549 TRANEXAMIC ACID FILM COATED TABLETS 500MG<br />

9000412 TRANYLCYPROMINE SUGAR COATED TABLETS 10MG<br />

9900282 TRASICOR TABLETS 40MG<br />

8500612 TRAUMON GEL 10%<br />

9400256 TRAUMON SPRAY 10%<br />

9500504 TRAZOLAN FILM COATED TABLETS 100MG<br />

9300469 TREDOL TABLETS 100MG<br />

9300467 TREDOL TABLETS 25MG<br />

9300468 TREDOL TABLETS 50MG<br />

8900099 TRETINOIN LOTION 0.05%<br />

9400247 TRIACOMB CREAM<br />

9400287 TRIAMHEXAL SUSPENSION FOR INJECTION 40MG/ML, 1ML<br />

8900198 TRIATEC TABLETS 2.5MG<br />

8900199 TRIATEC TABLETS 5MG<br />

2000363 TRICEF 400 FILM COATED TABLETS 400MG<br />

2000364 TRICEF POWDER FOR ORAL SUSPENSION 100MG/5ML<br />

2000124 TRIDENOVAG CREAM<br />

8900710 TRIFLORAN FILM COATED TABLETS 5MG<br />

8900711 TRIFLUOPERAZINE FILM COATED TABLETS 1MG<br />

8000541 TRIFLUOPERAZINE SUGAR COATED TABLETS 5MG<br />

9900390 TRILEPTAL TABLETS 300MG<br />

9900389 TRILEPTAL TABLETS 600MG<br />

9900623 TRIMIRON TABLETS<br />

9800256 TRINIPATCH TRANSDERMAL SYSTEM 10MG<br />

9800255 TRINIPATCH TRANSDERMAL SYSTEM 5MG<br />

8000380 TRINORDIOL SUGAR COATED TABLETS<br />

9100141 TRISEQUENS FILM COATED TABLETS<br />

9100140 TRISEQUENS FORTE FILM COATED TABLETS<br />

9700079 TRITANRIX-HB INJECTION 10MCG/0.5ML DOSE<br />

8800431 TRIZOLIN FILM COATED TABLETS 400MG<br />

9900008 TROFOCARD ENTERIC COATED TABLETS<br />

9400181 TROPEX EAR DROPS<br />

9500685 TRUSOPT EYE DROPS 2%<br />

7000442 TRUXAL TABLETS 15MG<br />

7000441 TRUXAL TABLETS 50MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 89<br />

Code No Product<br />

7100744 TRYPTIZOL TABLETS 10MG<br />

7100743 TRYPTIZOL TABLETS 25MG<br />

9800513 TWINRIX ADULT INJECTION<br />

9800512 TWINRIX JUNIOR INJECTION<br />

9800536 TYLENOL DROPS 100MG/ML<br />

9800533 TYLENOL SUPPOSITORIES 100MG<br />

9800534 TYLENOL SUPPOSITORIES 200MG<br />

9800535 TYLENOL SUPPOSITORIES 350MG<br />

9900243 TYPHERIX INJECTION 25MCG/0.5ML<br />

9500135 TYZINE NASAL SPRAY 0.1%<br />

9100425 ULCAR ORAL SUSPENSION 1G IN SACHETS<br />

8800545 ULCAR TABLETS 1G<br />

8600723 ULCEDINE FILM COATED TABLETS 20MG<br />

8600724 ULCEDINE FILM COATED TABLETS 40MG<br />

8600589 ULCERAN FILM COATED TABLETS 20MG<br />

8600590 ULCERAN FILM COATED TABLETS 40MG<br />

9900638 ULCERAN TABLETS 10MG<br />

9000184 ULFAMID FILM COATED TABLETS 20MG<br />

9000185 ULFAMID FILM COATED TABLETS 40MG<br />

9800237 ULTOP CAPSULES 20MG<br />

8100547 ULTRACARBON TABLETS 250MG<br />

8800664 ULTRACORTENOL EYE DROPS 0.5%<br />

8800663 ULTRACORTENOL EYE OINTMENT 0.5%<br />

9900115 ULTRADERME CREAM 4.4%<br />

7100166 ULTRALAN TABLETS 20MG<br />

7100165 ULTRALAN TABLETS 5MG<br />

8900383 ULTRATARD HM SUSP. FOR INJ.100IU/ML, 10ML VIALS<br />

8500276 ULTRAVIST 240 INJECTION 498.72MG/ML, 50ML<br />

2000057 ULTRAVIST 300 INJECTION 100ML<br />

9700617 ULTRAVIST 300 INJECTION 200ML<br />

9700616 ULTRAVIST 300 INJECTION 500ML<br />

8500282 ULTRAVIST 300 INJECTION 623.40MG/ML, 20ML<br />

8500277 ULTRAVIST 300 INJECTION 623.40MG/ML, 50ML<br />

9700615 ULTRAVIST 370 INJECTION 200ML<br />

2000058 ULTRAVIST 370 INJECTION 50ML<br />

9400333 UNIFLU WITH GREGOVITE C SUGAR COATED TABLETS<br />

9400330 UNIROID OINTMENT<br />

9400329 UNIROID SUPPOSITORIES<br />

9400026 UNTANO CREAM 2%<br />

9900097 UNTANO VAGINAL CREAM<br />

8100185 UPSATON AMPOULES DRINKABLE 10ML<br />

9000234 UROCTAL ENTERIC COATED TABLETS 400MG


EN<br />

90 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

7300307 UROGRAFIN INJECTION 76%(370MGI/ML), 20ML<br />

9600479 URO-TARIVID FILM COATED TABLETS 100MG<br />

8900631 UROVIDEO INJECTION 60%, 20ML 295MGI/ML<br />

8900632 UROVIDEO INJECTION 75%, 20ML<br />

8400440 URSOFALK CAPSULES 250MG<br />

9900495 UTEL TABLETS 10MG<br />

9100365 UTROGESTAN SOFT GELATIN CAPSULES 100MG<br />

8400031 UVAMIN RETARD CAPSULES 100MG<br />

9300393 UVIMAG B6 AMPOULES DRINKABLE<br />

8500322 UVISOL TABLETS 5MG<br />

7900246 VACONTIL TABLETS 2MG<br />

9500060 VAGIFEM VAGINAL TABLETS 25MCG<br />

7100476 VALIUM INJECTION 5MG/ML, 2ML AMPOULES<br />

7100474 VALIUM TABLETS 10MG<br />

7100473 VALIUM TABLETS 5MG<br />

9400215 VALONTAN TABLETS 100MG<br />

9000119 VALORAN POWDER FOR INJECTION 1G VIAL<br />

9000118 VALORAN POWDER FOR INJECTION 2G VIAL<br />

9000120 VALORAN POWDER FOR INJECTION 500MG VIAL<br />

9500053 VALTREX TABLETS 500MG<br />

9200108 VANCOMYCIN POWDER FOR INJECTION 500MG VIAL<br />

8900803 VASCOTEN FILM COATED TABLETS 50MG<br />

9600477 VASOPOS N EYE DROPS<br />

8300043 VASTAREL DROPS 20MG/ML, 60ML<br />

8300044 VASTAREL TABLETS 20MG<br />

8800517 VAXIGRIP SUSP. FOR INJ.0.5ML SYRINGE<br />

9900118 VAXIGRIP-PAEDIATRIC USE INJECTION<br />

9600425 VECTAVIR CREAM<br />

7000109 VELBE PDR FOR INJ. 10MG<br />

8500545 VELORIN FILM COATED TABLETS 100MG<br />

8800662 VELORIN FILM COATED TABLETS 50MG<br />

9900637 VENLAFAXINE TABLETS 37.5MG<br />

9900635 VENLAFAXINE TABLETS 50MG<br />

9900636 VENLAFAXINE TABLETS 75MG<br />

8400318 VENORUTON GEL 2%<br />

9600248 VENTIDE INHALER<br />

9600474 VENTOLIN ACCUHALER (DISKUS) POWDER FOR INHALATION 200MCG<br />

9900264 VENTOLIN EVOHALER AEROSOL 100MCG/DOSE<br />

9600241 VENTOLIN INHALER 100MCG/DOSE<br />

9600244 VENTOLIN RESPIRATOR SOLUTION FOR INHALATION 5MG/ML, 20ML<br />

9700636 VENTOLIN TABLETS 4MG<br />

9900421 VERAPLEX TABLETS 100MG<br />

9900431 VERAPLEX TABLETS 250MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 91<br />

Code No Product<br />

9900425 VERAPLEX TABLETS 500MG<br />

7600455 VERMOX SUSP. 2%<br />

7600454 VERMOX TABLETS 100MG<br />

8500334 VERMOX TABLETS 500MG<br />

9000316 VEROLIN ENTERIC COATED TABLETS 5MG<br />

8600560 VERTIGO-VOMEX CR SUSTAINED RELEASE CAPSULES<br />

9900337 VI SKALD IX TABLETS 10MG<br />

9800265 VIAGRA FILM COATED TABLETS 100MG<br />

9800263 VIAGRA FILM COATED TABLETS 25MG<br />

9800264 VIAGRA FILM COATED TABLETS 50MG<br />

9000417 VIBRAMYCIN DISPERSIBLE TABLETS 100MG<br />

9000193 VIBROCIL-S DROPS<br />

9000194 VIBROCIL-S GEL<br />

9000195 VIBROCIL-S SPRAY<br />

9900613 VICOMBIL SYRUP<br />

9900614 VICOMBIL TABLETS<br />

8300293 VIDISEPT N EYE DROPS<br />

8700468 VIDISIC GEL 0.2%<br />

2000161 VIGAM LIQUID 5%, 100ML<br />

2000162 VIGAM LIQUID 5%, 200ML<br />

2000160 VIGAM LIQUID 5%, 50ML<br />

7101265 VIMINOVA ELIXIR<br />

8800499 VINBLASTINE SULPHATE PDR FOR INJ. 10MG WITH 10ML SOLV<br />

9800407 VINCRISTINE POWDER FOR INJECTION 2MG<br />

8800498 VINCRISTINE SULPHATE INJECTION 1MG/ML, 1ML VIALS<br />

9700624 VIOPLEX-T SPRAY POWDER<br />

9900133 VIOXX ORAL SUSPENSION 12.5MG/5ML<br />

9900132 VIOXX ORAL SUSPENSION 25MG/5ML<br />

9900130 VIOXX TABLETS 12.5MG<br />

9900131 VIOXX TABLETS 25MG<br />

9900411 VIRAMUNE SUSPENSION 50MG/5ML<br />

9500036 VIRUCID TABLETS 200MG<br />

9500037 VIRUCID TABLETS 400MG<br />

9500038 VIRUCID TABLETS 800MG<br />

9700545 VIRUNGUENT OINTMENT 0.2%<br />

9700173 VISCOAT INJECTION 0.5ML<br />

7300084 VISINE EYE DROPS 0.05%<br />

9900524 VISIONACE CAPSULES<br />

9900338 VISKEN TABLETS 5MG<br />

8100520 VITA-CEDOL ORANGE CHEWABLE TABLETS 100MG<br />

9500705 VITA-CEDOL PLUS CHEWABLE TABLETS 500MG<br />

7000126 VITAMIN A EYE OINTMENT 10000IU/G<br />

8000584 VITAMIN B COMPOUND FILM COATED TABLETS


EN<br />

92 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

8000585 VITAMIN B COMPOUND STRONG FILM COATED TABLETS<br />

99F0221 VITAMIN B6 CAPSULES 10MG<br />

9900628 VITAMIN C CHEWABLE TABLETS 500MG<br />

9900199 VITAMIN C ORANGE FLAVOUR TABLETS 1000MG<br />

9300554 VITAMIN C TABLETS 100MG<br />

9900601 VITAMIN C TABLETS 100MG<br />

96F0084 VITAMIN C TABLETS 500MG<br />

9300555 VITAMIN C TABLETS 500MG<br />

9900602 VITAMIN C TABLETS 500MG<br />

9300553 VITAMIN C TABLETS 50MG<br />

9900600 VITAMIN C TABLETS 50MG<br />

97F0153 VITAMIN E SOFT GELATIN CAPSULES 100IU<br />

2000111 VITAMIN E SOFT GELATIN CAPSULES 400IU<br />

9900551 VITAMIST ANTI-OXIDANT SPRAY<br />

9900555 VITAMIST B12 SPRAY<br />

9900554 VITAMIST C+ZINC SPRAY OR<br />

9900552 VITAMIST FOLACIN SPRAY<br />

99F0549 VITAMIST MULTIPLE SPRAY<br />

99F0550 VITAMIST PRENATAL SPRAY<br />

8900444 VITANOL SUGAR COATED TABLETS<br />

8400044 VITIRON SUSTAINED RELEASE CAPSULES<br />

7000132 VITREOLENT EYE DROPS<br />

7101237 VIVIOPTAL CAPSULES<br />

2000350 VOFENAC GEL 1%<br />

9600246 VOLMAX TABLETS 4MG<br />

9600247 VOLMAX TABLETS 8MG<br />

9900394 VOLTAREN D DISPERSIBLE TABLETS 50MG<br />

2000242 VOLTAREN EMULGEL 1%<br />

9900349 VOLTAREN ENTERIC COATED TABLETS 25MG<br />

9900371 VOLTAREN ENTERIC COATED TABLETS 50MG<br />

9900370 VOLTAREN FOR CHILDREN SUPPOSITORIES 12.5MG<br />

9900348 VOLTAREN INJECTION 75MG/3 ml<br />

9900360 VOLTAREN RETARD SUSTAINED RELEASE TABLETS 100MG<br />

9900374 VOLTAREN SR SUSTAINED RELEASE TABLETS 75MG<br />

9900373 VOLTAREN SUPPOSITORIES 100MG<br />

9900359 VOLTAREN SUPPOSITORIES 50MG<br />

2100075 VOSOL EAR DROPS<br />

2100076 VOSOL HC EAR DROPS<br />

95F0220 VV PACK TABLETS<br />

8900122 WARI-DICLOWAL ENTERIC COATED TABLETS 50MG<br />

8900124 WARI-DICLOWAL INJECTION 25MG/ML, 3ML<br />

8900123 WARI-DICLOWAL SUSTAINED RELEASE TABLETS 100MG<br />

9400309 WARIMAZOL DERM CREAM 1%


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 93<br />

Code No Product<br />

2000228 WARIMAZOL VAG 200 VAGINAL TABLETS 200MG<br />

9400311 WARIMAZOL VAGINAL CREAM 1%<br />

9300511 WASP-EZE SPRAY<br />

2000193 WASSEN COENZYME Q10 + MAGNESIUM TABLETS<br />

9500600 WATER FOR INJECTION 10ML<br />

8500442 WATER FOR INJECTION INJECTION 10ML<br />

98F0003 WELLMAN CAPSULES<br />

21F0002 WELLWOMAN CAPSULES<br />

8500359 XANAX TABLETS 0.25MG<br />

8500360 XANAX TABLETS 0.5MG<br />

8900190 XANAX TABLETS 1MG<br />

9600451 XATRAL SUSTAINED RELEASE TABLETS 5MG<br />

2000609 XATRAL XL PROLONGED RELEASE TABLETS 10MG<br />

9800540 XENICAL CAPSULES 120MG<br />

9800543 XOROX DRY SUBSTANCE INFUSION<br />

9800547 XOROX EYE OINTMENT 3%<br />

9800546 XOROX TABLETS 200MG<br />

9800544 XOROX TABLETS 400MG<br />

9800545 XOROX TABLETS 800MG<br />

7100387 XYLOCAINE ADRENALINE 1% INJECTION<br />

7100388 XYLOCAINE ADRENALINE 2% INJECTION<br />

7700302 XYLOCARD INFUSION 20%, 5ML SYRINGES<br />

7700104 XYLONOR 2% NORADRENALINE INJECTION 2%, 1.8ML CARTR.<br />

8900412 XYLONOR 3% NORADRENALINE INJECTION 3%,1.8ML CARTRIDGE<br />

7500079 XYLONOR SPRAY<br />

7101268 XYLOPROCT OINTMENT<br />

7101267 XYLOPROCT SUPPOSITORIES<br />

8800056 YOHIMBINE HCL CAPSULES 6MG<br />

8000024 YUTOPAR INFUSION 10MG/ML, 5ML AMPS<br />

8000025 YUTOPAR TABLETS 10MG<br />

9200250 ZABYSEPT EYE DROPS<br />

2000438 ZACIN CREAM 0.025% W/W<br />

2000445 ZADITEN EYE DROPS 0.345MG/ML<br />

9900340 ZADITEN SRO- SUSTAINED RELEASE TABLETS 2MG<br />

9900341 ZADITEN SYRUP 1MG/5ML<br />

9900339 ZADITEN TABLETS 1MG<br />

9200309 ZAFIBRAL FILM COATED TABLETS 200MG<br />

9500128 ZAFOR CAPSULES<br />

9600251 ZANTAC EFFERVESCENT TABLETS 150MG<br />

9700635 ZANTAC EFFERVESCENT TABLETS 300MG<br />

9600249 ZANTAC FILM COATED TABLETS 150MG<br />

9700076 ZANTAC OTC TABLETS 75MG<br />

9600250 ZANTAC TABLETS 300MG


EN<br />

94 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

9900621 ZEFFIX ORAL SOLUTION 5MG/ML<br />

9900622 ZEFFIX TABLETS 100MG<br />

2000164 ZENALB 20 LIQUID 20%, 100ML<br />

2000163 ZENALB 20 LIQUID 20%, 50ML<br />

9600168 ZENICLOR CAPSULES 500MG<br />

9600165 ZENICLOR ORAL SUSPENSION 250MG/5ML<br />

9600166 ZENICLOR ORAL SUSPENSION 375MG/5ML<br />

9000325 ZENTEL SUSP. 100MG/5ML<br />

9000324 ZENTEL TABLETS 200MG<br />

8900300 ZENUSIN CAPSULES 5MG<br />

8900522 ZEPILEN POWDER FOR INJECTION 1G VIALS<br />

8900521 ZEPILEN POWDER FOR INJECTION 250MG VIAL<br />

8900225 ZEPILEN POWDER FOR INJECTION 500MG VIAL<br />

9000548 ZESTAVAL FILM COATED TABLETS 200MG<br />

9200358 ZESTORETIC TABLETS<br />

8900700 ZESTRIL TABLETS 10MG<br />

8900701 ZESTRIL TABLETS 20MG<br />

8900699 ZESTRIL TABLETS 5MG<br />

9900605 ZIDONIL CAPSULES 100MG<br />

9900103 ZILISTEN INJECTION 1.5G<br />

8600736 ZILISTEN POWDER FOR INJECTION 750MG<br />

95F0217 ZIMAN PLUS TABLETS<br />

97F0193 ZINC TABLETS<br />

20F0039 ZINC TABLETS 25MG<br />

9000046 ZINDOLIN FILM COATED TABLETS 250MG<br />

9300090 ZINDOLIN FILM COATED TABLETS 500MG<br />

9600258 ZINNAT (BOTTLES) ORAL SUSPENSION 125MG/5ML<br />

9600255 ZINNAT TABLETS 125MG<br />

9600256 ZINNAT TABLETS 250MG<br />

9600257 ZINNAT TABLETS 500MG<br />

9500395 ZITHROMAX CAPSULES 250MG<br />

9500396 ZITHROMAX POWDER FOR ORAL SUSP. 200MG/5ML<br />

8800635 ZOCOR FILM COATED TABLETS 10MG<br />

9500165 ZOCOR FILM COATED TABLETS 20MG<br />

9600161 ZOCOR FILM COATED TABLETS 40MG<br />

9600259 ZOFRAN INJECTION 2MG/ML, 2ML<br />

9900529 ZOFRAN MELT TABLETS 4MG<br />

9900530 ZOFRAN MELT TABLETS 8MG<br />

9800472 ZOFRAN SUPPOSITORIES 16MG<br />

9800519 ZOFRAN SYRUP 4MG/5ML<br />

9600445 ZOIRAL CAPSULES 10MG<br />

9500366 ZOIRAL CAPSULES 25MG<br />

9500367 ZOIRAL CAPSULES 50MG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 95<br />

Code No Product<br />

9800435 ZOIRAL TABLETS 10MG<br />

9800436 ZOIRAL TABLETS 25MG<br />

9800437 ZOIRAL TABLETS 50MG<br />

9100281 ZOLADEX DEPOT INJECTION 3.6MG SYRINGE<br />

9900020 ZOLADEX LA INJECTION 10.8MG<br />

9300417 ZOLAREM TABLETS 0.25MG<br />

9300416 ZOLAREM TABLETS 0.5MG<br />

9400168 ZOLAREM TABLETS 1MG<br />

9400061 ZOLOFT TABLETS 100MG<br />

9400060 ZOLOFT TABLETS 50MG<br />

8900607 ZOVIRAX DISPERSIBLE TABLETS 800MG<br />

9400515 ZOVIRAX DS ORAL SUSP. 80MG/ML<br />

8200105 ZOVIRAX OPHTHALMIC OINTMENT 3%<br />

8600024 ZOVIRAX SUSPENSION 200MG/5ML<br />

8400217 ZOVIRAX TOPICAL CREAM 5%<br />

9500113 ZYLAPOUR TABLETS 300MG<br />

8100258 ZYLORIC TABLETS 100MG<br />

8100219 ZYLORIC TABLETS 300MG<br />

9800131 ZYMOPLEX TABLETS 10MG<br />

9800126 ZYMOPLEX TABLETS 20MG<br />

9600552 ZYPREXA TABLETS 10MG<br />

9600551 ZYPREXA TABLETS 5MG<br />

9000251 ZYRTEC FILM COATED TABLETS 10MG<br />

9500272 ZYRTEC ORAL DROPS 10MG/ML<br />

9500273 ZYRTEC ORAL SOLUTION 0.1%<br />

LIST B: VETERINARY MEDICINAL PRODUCTS<br />

Code No Product<br />

88V0445 AAGENT INJECTION 50MG/ML, 100ML<br />

20V0375 ADEQUAN INJECTION 100MG/ML<br />

99V0028 ADVANTAGE FOR DOGS SOLUTION 10%<br />

99V0029 ADVANTAGES FOR CATS SOLUTION 10%<br />

97V0233 AFTER CALF BOLUS<br />

95V0370 ALAMYCIN AEROSOL 30MG/ML<br />

95V0242 ALAMYCIN LA 300 INJECTION 300MG/ML<br />

85V0154 ALAMYCIN LA INJECTION 20%, 100ML<br />

90V0259 ALBIPEN LA INJECTION 100MG/ML, 80ML<br />

95V0235 AMOXICILLIN TRIHYDRATE POWDER FOR ORAL ADMINISTRATION 11.5%<br />

94V0486 AMOXINJECT LA SUSPENSION FOR INJECTION 150MG/ML, 50ML<br />

93V0260 AMOXINSOL POWDER 50%<br />

96V0368 AMOXYCILLIN WATER SOLUBLE POWDER 15%<br />

98V0272 AMOXY-KEL SUSPENSION FOR INJECTION 15%


EN<br />

96 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

83V0146 AMPICILLIN SUSPENSION FOR INJECTION 200MG/ML, 100ML<br />

97V0538 AMPICILLINA WATER SOLUBLE POWDER 20%<br />

95V0585 AMPIDOX POWDER 50G/KG<br />

99V0632 AMPISUR SUSPENSION FOR INJECTION<br />

72V1274 AMPROL PLUS POWDER<br />

92V0133 ATIQUINE SUSPENSION FOR INJECTION 5%, 100ML BOTTLES<br />

92V0134 ATIQUINE WATER SOLUBLE POWDER 10% W/W<br />

20V0402 AVATEC CC POWDER 15%<br />

98V0179 B-1 NEWCASTLE DISEASE<br />

99V0189 BACOLAM SUSPENSION FOR INJECTION<br />

99V0190 BACOLAM WATER SOLUBLE POWDER<br />

94V0347 BANMITH FOR CATS PASTE<br />

93V0065 BANMITH ORAL SUSPENSION<br />

99V0643 BAR VAC ELITE 4 HS INJECTION 5ML PER DOSE<br />

95V0334 BAYCOX SOLUTION 2.5%<br />

87V0585 BAYTRIL INJECTION 5%, 100ML<br />

90V0642 BAYTRIL INJECTION 5%, 50ML<br />

87V0586 BAYTRIL ORAL SOLUTION 10%<br />

98V0219 BAYVERM BOLUS 300MG<br />

91V0010 BETAMOX TABLETS 200MG<br />

91V0012 BETAMOX TABLETS 400MG<br />

91V0011 BETAMOX TABLETS 40MG<br />

95V0492 BIATOX E LIQUID<br />

20V0373 BIMASTAT ORAL SUSPENSION<br />

21V0018 BIOCILLIN-150 INJECTION 150MG/ML, 100ML<br />

20V0359 BIODYL INJECTION<br />

98V0286 BLOOD STOP POWDER<br />

89V0160 BOB MARTIN DUAL WORMER FOR CATS TABLETS 250/275MG<br />

89V0161 BOB MARTIN DUAL WORMER FOR DOGS TABLETS 500/275MG<br />

99V0030 BOLFO SPRAY 0.25%<br />

85V0155 BOVACLOX DC SUSPENSION FOR INTRAMAMMARY ADMINISTRATION<br />

95V0314 BOVACLOX DC XTRA INJECTION<br />

99V0215 BREMAMED TS1 POWDER 100G<br />

93V0544 BRONCHITIS VACCINE INJECTION<br />

93V0546 BURSAL DISEASE VACCINE (VI-BURSA-L) (CODE 1493) POWDER FOR RECONSTITUTION 1000<br />

DOSES<br />

94V0394 BURSAL DISEASE VACCINE, LIVE VIRUS (VI BURSA-CE) POWDER FOR RECONSTITUTION 1000<br />

DOSES<br />

94V0395 BURSAL DISEASE VACCINE, LIVE VIRUS (VI BURSA-G) POWDER FOR RECONSTITUTION 1000<br />

DOSES BOTTLE<br />

95V0382 BURSAL-NEWCASTLE-BRONCHITIS VACCINE INJECTION 500 DOSES<br />

95V0563 CALCI TAD 25 INFUSION<br />

91V0007 CALCIJECT INJECTION 400ML<br />

95V0631 CALCIJECT LV INJECTION


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 97<br />

Code No Product<br />

88V0444 CALCIO PH INJECTION 250ML<br />

90V0161 CALIERCORTIN INJECTION 4MG/ML, 50ML<br />

84V0205 CANAURAL EAR DROPS<br />

96V0209 CATOSAL 10% INJECTION 50ML<br />

95V0484 CEFAMAST INTRAMAMMARY OINTMENT<br />

20V0246 CESTAL CAT TABLETS<br />

20V0101 CESTAL PLUS TABLETS<br />

96V0324 CEVAC BRON 120 L POWDER 10-3.5 EID50/DOSE<br />

96V0320 CEVAC BURSA L POWDER 10-2.4 EID50/DOSE<br />

96V0322 CEVAC IBD L POWDER 10-2 EID50/DOSE<br />

96V0321 CEVAC NEW L POWDER 10-5.5 EID50/DOSE<br />

96V0323 CEVAC UNI L POWDER 10-5.5 EID50/DOSE<br />

20V0317 CEVAC VITAPEST L<br />

99V0027 CHLORSOL 50 WATER SOLUBLE POWDER 50%<br />

97V0347 CHLORTETRACYCLINE HCL PREMIX POWDER 10%<br />

74V0384 CHORULON POWDER FOR INJECTION 1500IU WITH 1ML SOLV<br />

98V0587 CITIFAC CTC POWDER 15%<br />

95V0526 CLAMOXYL WATER SOLUBLE POWDER<br />

92V0332 CLINACOX PREMIX POWDER 0.5%<br />

98V0509 CLOPEN 250 POWDER 25%<br />

92V0546 CLOXACUM INTRAMAMMARY INFUSION 5%, 10ML SYRINGES<br />

92V0347 CM1640 CHLORTETRACYCLINE 150 F.G. POWDER 15%<br />

92V0282 CM1683 OXYTETRACYCLINE HCL 10% F G POWDER 10%<br />

92V0283 CM1738 AMPICILLIN TRIHYDRATE COMP 10% F G POWDER 10%<br />

93V0251 CM1788 PNEUMOPHYLL POWDER<br />

93V0257 CM1865 AMPICILLIN 20 POWDER 17.3%<br />

93V0516 CM1866 AMPICILLIN 50 POWDER 43.3%<br />

93V0517 CM1915 TYLOSIN PHOSPHATE 10% POWDER 10%<br />

94V0043 CM1936 POWDER<br />

97V0400 CM2051TRIMETHOPRIM 50 + SULPHADIMIDINE 250 POWDER<br />

95V0592 CM2074 TRIMETHOPRIM 50 + SULPHADIAZINE 250 F.G. POWDER<br />

92V0194 CM971 OXYTETRACYCLINE 10% ACTIVITY POWDER 10%<br />

98V0575 COCCIROB-66 ORAL POWDER 66MG/G<br />

85V0499 COENZILE POWDER FOR INJECTION WITH 20ML SOLVENT<br />

20V0102 COGLAVAX SUSPENSION FOR INJECTION<br />

94V0271 COLIMUNE ORAL SOLUTION<br />

87V0161 COLINDOX WATER SOLUBLE POWDER 100G/KG<br />

99V0128 COLISTIN SULPHATE 12% WATER SOLUBLE POWDER 12%<br />

95V0313 COLVASONE INJECTION 2MG/ML, 50ML<br />

95V0589 COMBIVIT INJECTION 135.5MG/ML, 1ML<br />

85V0156 COMBIVIT INJECTION 50ML<br />

99V0114 COMBIVIT MA POWDER FOR ORAL ADMINISTRATION<br />

83V0487 COSUMIX PLUS WATER SOLUBLE POWDER


EN<br />

98 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

89V0558 COVINAN INJECTION 100/ML, 20ML<br />

99V0193 COYDEN 25 POWDER 25%<br />

99V0112 DECTIVER PASTE 4.8MG/ML<br />

98V0585 DEPOTOCIN INJECTION 0.07MG/ML<br />

85V0157 DEVOMYCIN INJECTION 250MG/ML, 100ML<br />

97V0348 DEXAMETHASONE INJECTION 2MG/ML<br />

74V0386 DEXAPRESON 2MG/ML, 20ML<br />

20V0105 DICURAL ORAL SOLUTION 100MG/ML<br />

94V0114 DIPEN 15/20 INJECTION 100ML<br />

73V0090 DL-VETO METHIONINE INJECTION 20%, 150ML<br />

99V0247 DOXYVIT 100 WATER SOLUBLE POWDER 10%<br />

94V0335 DRINKMIX COLISTIN POWDER<br />

94V0117 DRONCIT INJECTION 56.8 MG/ML, 10ML<br />

94V0118 DRONCIT TABLETS 50 MG<br />

98V0051 DURAMUNE CV-K INJECTION<br />

98V0052 DURAMUNE DA2LP+PV INJECTION<br />

98V0050 DURAMUNE KF-11 INJECTION<br />

90V0257 ECTOPOR SA 020 SOLUTION 2%<br />

95V0485 ENDOPITUITRINA FORTE VETERINARIA INJECTION 240IU<br />

90V0242 ENGEMYCIN LA INJECTION 10%, 100ML<br />

98V0515 ENZAPROST 25 INJECTION 0.5%<br />

92V0564 EQUIPALAZONE POWDER FOR ORAL ADMINISTRATION IN SACHETS<br />

83V0534 EQVALAN PASTE 1.87% IN 6.42G SYRIN<br />

92V0129 ERY-SUIVAX INJECTION<br />

73V0189 ESB 3 WATER SOLUBLE POWDER 30%<br />

97V0339 EXCENEL SUSPENSION FOR INJECTION 50MG/ML<br />

20V0140 EXSPOT SOLUTION 65% W/W<br />

85V0500 FATROCORTIN INJECTION 1MG/ML, 100ML<br />

98V0053 FEL-O-VAX PCT INJECTION 1ML VIALS<br />

85V0210 FERRUM INJECTION 100MG/ML, 100ML<br />

98V0461 FLUNIXIN INJECTION 50MG/ML (100ML)<br />

98V0460 FLUNIXIN INJECTION 50MG/ML (50ML)<br />

76V0412 FOLLIGON POWDER FOR INJECTION 1000IU WITH 5ML DIL.<br />

20V0103 FORTICLINA RETARD INJECTION<br />

93V0542 FOWL LARYNGOTRACHEITIS VACCINE INJECTION<br />

99V0032 FRA-SEL 10 LIQUID 10%<br />

99V0087 FRONTLINE SPOT- ON DOG (10-20KG) SOLUTION 10% W/V<br />

99V0062 FRONTLINE SPOT-ON CAT SOLUTION 10% W/V<br />

99V0086 FRONTLINE SPOT-ON DOG (10KG) SOLUTION 10% W/V<br />

99V0088 FRONTLINE SPOT-ON DOG (20-40KG) SOLUTION 10%W/V<br />

99V0108 FRONTLINE SPRAY<br />

95V0483 GELLISULFA INJECTION<br />

20V0108 GLEPTOSIL INJECTION 200MG/ML


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 99<br />

Code No Product<br />

20V0141 GLETVAX 6 INJECTION<br />

98V0584 GONAVET INJECTION 50MG/ML<br />

98V0282 GOOD START CALF PASTE<br />

20V0372 HEXASOL LA INJECTION 50ML<br />

98V0177 IB-H-120 INFECTIOUS BRONCHITIS<br />

98V0180 ILT INFECTIOUS LARYNGOTRACHEITIS<br />

74V0387 INTERTOCINE-S INJECTION 10IU/ML, 25ML<br />

93V0380 INTRADINE INJECTION 33%, 100ML<br />

21V0027 INTRAFER-200 B12 INJECTION<br />

94V0260 INTRAMICINE SUSPENSION FOR INJECTION 100ML<br />

95V0132 IRON DEXTRAN 10% INJECTION<br />

95V0133 IRON DEXTRAN 20% INJECTION<br />

97V0345 IVAVIT WATER SOLUBLE POWDER<br />

84V0649 IVOMEC SWINE INJECTION 10MG/ML, 100ML<br />

98V0271 KANA-KEL INJECTION 10%<br />

98V0598 KELAMYCIN SUSPENSION<br />

91V0005 KETOSAID LIQUID 100%<br />

95V0233 KLATOCLOX SUSPENSION 625MG<br />

20V0322 KOFFOGRAN FEED PREMIX POWDER 25%<br />

20V0321 KOFFOZIN FEED PREMIX POWDER 25%<br />

86V0236 LACTACLOX SUSPENSION FOR INTRAMAMMARY ASMINISTRATION 5G SYRINGES<br />

98V0199 LASOTA (NEWCASTLE DISEASE)<br />

99V0192 LERBEK 20 POWDER 20%<br />

95V0530 LEUKOCELL 2 SUSPENSION FOR INJECTION<br />

88V0622 LEVACIDE INJECTION 7.5% W/V<br />

95V0486 LEVOSOL G A INJECTION 7.5G<br />

91V0003 LIFE-AID LIQUID<br />

91V0004 LIFE-AID P WATER SOLUBLE POWDER<br />

21V0024 LIMOXIN-100 IJNECTION 100MG/ML, 100ML<br />

21V0019 LIMOXIN-25 ANTISEPTIC SPRAY 25MG/ML, 200ML<br />

78V0325 LINCO-SPECTIN 100 WATER SOLUBLE POWDER 150G<br />

91V0367 LINCO-SPECTIN INJECTION 100ML<br />

99V0419 LIVACOX SUSP ORAL SUSPENSION<br />

78V0349 LUTALYSE INJECTION 5MG/ML, 10ML VIAL<br />

21V0030 MACROLAN-200 INJECTION 200MG/ML, 100ML<br />

98V0405 MAMIFORT SECADO SUSPENSION FOR INTRAMAMMARY ADMINISTRATION<br />

98V0404 MAMIFORT SUSPENSION FOR INTRAMAMMARY ADMINISTRATION<br />

96V0028 MAREK'S DISEASE VACCINE HVT/SB1-RISPENS INJECTION<br />

96V0027 MAREK'S DISEASE VACCINE HVT RISPENS INJECTION<br />

96V0503 MAREKS-LIVE TURKEY HERPESVIRUS VACCINE CELL ASSOCIATED INJECTION 2000 DOSES<br />

98V0510 MAXIDOX LIQUID<br />

93V0182 MAXIFORT ORAL SOLUTION<br />

99V0148 MAXUS G 100 FEED PREMIX POWDER 10%


EN<br />

100 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

99V0147 MAXUS G 200 FEED PREMIX POWDER 10%<br />

98V0176 MB INFECTIOUS BURSAL DISEASE<br />

20V0007 MEGAVAC-6 INJECTION<br />

93V0221 METABOLASE INJECTION 500ML<br />

95V0251 METAPHOSOL INJECTION<br />

95V0250 MIOCOL POWDER FOR ORAL ADMINISTRATION 52.64MG/G<br />

96V0273 MULTIVIT ORAL SOLUTION 1000ML<br />

85V0158 MULTIVITAMIN INJECTION<br />

99V0101 MYCO SHIELD INJECTION 100ML/100DOSES<br />

86V0037 NEATOX INJECTION 250ML<br />

83V0516 NEO MASTITAR SUSPENSION 8G INJECTOR<br />

84V0093 NEOCIDOL 60 LIQUID 60% W/V<br />

99V0127 NEO-OSSITETRA 200 F.G. POWDER 20%<br />

97V0344 NEO-OXYVET PREMIX POWDER<br />

97V0346 NEO-OXYVET WATER SOLUBLE POWDER<br />

90V0497 NEOPEN INJECTION 100ML<br />

92V0398 NEO-TERRAMYCIN POWDER IN SACHETS<br />

88V0551 NEO-TERRAMYCIN PREMIX POWDER<br />

93V0545 NEWCASTLE DISEASE VACCINE INJECTION<br />

95V0381 NEWCASTLE-BRONCHITIS (CHICK POLY BANCO) SOLUTION<br />

92V0607 NOBILIS GUMBORO 228E POWDER FOR RECONSTITUTION 100EID50/DS, 1000 DS<br />

95V0027 NOBILIS IB + G+ ND INJECTION 0.5ML<br />

89V0801 NOBILIS IB MA5 POWDER FOR RECONSTITUTION 10-3EID50/DOSE, 1000D<br />

90V0389 NOBILIS MA5 + CLONE 30 POWDER FOR INJECTION 1000 DOSES PER VIAL<br />

95V0028 NOBILIS MAREXINE CA 126 POWDER FOR INJECTION 1000PFU/DOSE<br />

90V0402 NOBILIS NEWCAVAC INJECTION 50PD50U/0.5ML,500ML<br />

94V0477 NOBILIS TRT INAC POWDER FOR RECONSTITUTION<br />

92V0572 NOBI-VAC AUJESZKY (GI-) INJECTION 100ML(=50DS)<br />

92V0571 NOBI-VAC AUJESZKY (GI-) INJECTION 20ML(=10 DS)<br />

99V0564 NOBIVAC CORONA INJECTION<br />

90V0376 NOBI-VAC DHP+L POWDER FOR INJECTION<br />

93V0190 NOBIVAC DHPPI POWDER FOR INJECTION 1DOSE VIAL WITH SOLV<br />

93V0176 NOBI-VAC EDS 76 INJECTION 500DOSES (=250ML)<br />

99V0525 NOBIVAC KC<br />

80V0452 NOBIVAC LEPTO INJECTION 1 DOSE<br />

90V0388 NOBIVAC PUPPY DP POWDER FOR INJECTION WITH 1ML SOLV<br />

94V0475 NOBIVAC RABIES INJECTION<br />

89V0451 NOBIVAC TRICAT POWDER FOR INJECTION 1DOSE WITH 1ML SOLV<br />

95V0588 NOROBRITTIN INJECTION 150MG/ML, 1ML<br />

85V0159 NOROBRITTIN SUSPENSION FOR INJECTION 150MG/ML, 100ML<br />

86V0238 NORODINE 24 INJECTION 100ML<br />

91V0008 NORODINE PIGLET ORAL SUSPENSION<br />

98V0597 NOROMECTIN DRENCH SOLUTION 0.8%


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 101<br />

Code No Product<br />

98V0582 NOROMECTIN INJECTION 1% W/V<br />

99V0509 NOROMECTIN INJECTION 1.%wv<br />

98V0596 NOROMECTIN POUR-ON SOLUTION 0.5%<br />

98V0459 NOROTYL LA SUSPENSION FOR INJECTION 150MG/ML<br />

98V0514 OCYTOCIN INJECTION 10IU/ML<br />

94V0121 OLVAC B+G INJECTION<br />

99V0642 ONTAVAC COMB 7 1ML/DOSE<br />

91V0009 OPTICLOX EYE OINTMENT 16.7% IN 5G SYRINGES<br />

89V0442 ORAMEC DRENCH FOR SHEEPS & GOATS SOLUTION 0.08%<br />

98V0160 OXITER WATER SOLUBLE POWDER 200G/KG<br />

86V0042 OXTRA INJECTION 100MG/ML, 100ML<br />

86V0046 OXTRA LONG ACTING INJECTION 20%, 100ML<br />

98V0284 OXY-MYCIN INJECTION<br />

99V0129 OXYTETRACYCLINE 20% WATER SOLUBLE POWDER 20%<br />

99V0117 OXYTETRACYCLINE/FLUNIXIN INJECTION<br />

89V0378 OXYTOCIN INJECTION 10IU/ML, 50ML<br />

21V0040 OXYTOCIN-10 INJECTION 10IU/ML, 50ML<br />

94V0540 OXYTOCIN-TAD INJECTION 10IU/ML, 50ML<br />

85V0255 OXYTO-KEL INJECTION 10IU/ML, 50ML<br />

88V0607 OXYVET SPRAY 2%<br />

79V0192 PANACUR BOLI BOLUS 250MG<br />

96V0325 PANCLOSTIL SUSPENSION FOR INJECTION<br />

90V0240 PARACILLIN WATER SOLUBLE POWDER 80%<br />

99V0228 PARACOX ORAL SUSPENSION<br />

20V0139 PARACOX-5 INJECTION<br />

95V0315 PARAFEND ORAL SUSPENSION 22.65MG/ML<br />

99V0099 PARAPLEURO SHIELD P+BE INJECTION 100ML/20DOSES<br />

88V0052 PATHOZONE INTRAMAMMARY SUSPENSION FOR INJECTION 28.44MG/ML 10ML<br />

85V0160 PEN & STREP SUSPENSION FOR INJECTION 100ML<br />

20V0170 PEN STREP INJECTION<br />

21V0016 PENSTREP-400 SUSPENSION FOR INJECTION<br />

98V0427 PORCILIS M INJECTION<br />

99V0100 PORCINE ECOLIZER 3+C SOLUTION 100 DOSES<br />

95V0249 PREDNISOLONE 1% SUSPENSION FOR INJECTION 10MG/ML<br />

99V0188 PULMOTIL AC 250MG/ML<br />

98V0608 PULMOTIL G100 PREMIX POWDER 10%<br />

98V0607 PULMOTIL G200 PREMIX POWDER<br />

20V0006 RAKSHARAB INJECTION<br />

95V0557 RESPISURE SUSPENSION FOR INJECTION<br />

20V0478 SALECO 120 POWDER 12% W/W<br />

97V0218 SCORDEX INJECTION 20%<br />

85V0502 SELEVIT INJECTION 10ML<br />

95V0583 SEQUAM LIQUID 200G/L


EN<br />

102 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Code No Product<br />

85V0211 SOLUVIT AD3E FORTE SOLUTION<br />

98V0586 SPASMOTITRAT INJECTION 400MG/ML<br />

83V0180 SPECTAM G A INJECTION 100MG/ML, 100ML<br />

99V0633 SPECTAM PASTE<br />

95V0489 SPRAYCIN SUSPENSION 1.3%<br />

83V0143 STREPTOPENICILLIN FORTE SUSPENSION FOR INJECTION<br />

89V0431 SULFADIMIDINE INJECTION 33%<br />

20V0302 SULFATRIM PREMIX POWDER 21%<br />

98V0283 SUPPRESSOR INJECTION<br />

85V0337 T61 INJECTION 50ML<br />

94V0537 TAD AE VAC SUSPENSION 1000EID50/DS, 1000DS<br />

95V0125 TAD GUMBORO VAC POWDER 10-5 EID50/1000DOSES<br />

94V0535 TAD IB VAC I POWDER FOR ORAL ADMINISTRATION 1000EID50/DS, 1000DS<br />

94V0534 TAD IB VAC II POWDER FOR ORAL ADMINISTRATION 1000EID50/DS, 1000DS<br />

94V0538 TAD ILT VAC POWDER FOR INJECTION 10-5.9EID50 WITH DIL<br />

94V0530 TAD MAREK VAC FORTE SUSPENSION FOR INJECTION 1000PFU/DS, 1000DS<br />

94V0533 TAD ND VAC HITCHNER B1 POWDER FOR RECONSTITUTION 1MILEID50/DS, 1000DS<br />

94V0532 TAD ND VAC LA SOTA POWDER FOR ORAL ADMINISTRATION 1MILEID50/D, 1000DS<br />

94V0539 TAD POX VAC POWDER FOR INJECTION 100EID50/DS, 1000DS<br />

94V0536 TAD REO VAC I POWDER FOR RECONSTITUTION 10THTCID50/DS, 1000DS<br />

21V0001 TAD SALMONELLA VAC E LYOPHILISED INJECTION<br />

97V0381 TAD SALMONELLA VAC T 10-8 CFU/ID<br />

99V0483 TAKTIC EMULSIFIABLE CONCENTRATE LIQUID 125G/L<br />

20V0437 TENALINE 50% WATER SOLUBLE POWDER 50%<br />

95V0082 TERRAMYCIN BEES SOLUBLE POWDER 5.5%<br />

70V0332 TERRAMYCIN FOR BEES WATER SOLUBLE POWDER 55MG/G, 100G<br />

95V0083 TERRAMYCIN SOLUBLE WATER SOLUBLE POWDER 20%<br />

95V0084 TERRAMYCIN WATER SOLUBLE POWDER 75.5%<br />

94V0116 TETROXY 10% INJECTION 100MG/ML, 100ML<br />

88V0391 TIAMUTIN INJECTION 100MG/ML, 100ML<br />

99V0150 TICOFF EMULSION 20%<br />

92V0547 TOCO-SELENIO INJECTION 100ML<br />

88V0446 TOXIDREN WATER SOLUBLE POWDER 1.5KG<br />

98V0236 TRIMEDIAZINE 30 PREMIX POWDER 30%<br />

94V0115 TRIVETAVIT FORTE INJECTION<br />

97V0441 TYLAN 200 INJECTION 200MG/ML<br />

97V0439 TYLAN PREMIX POWDER 10%<br />

97V0438 TYLAN PREMIX POWDER 25%<br />

97V0440 TYLAN WATER SOLUBLE POWDER 100%<br />

20V0171 TYLO 200 INJECTION 200MG<br />

85V0362 TYLOJECT INJECTION 20%, 100ML<br />

98V0490 ULTRAPEN LA SUSPENSION FOR INJECTION 300MG/ML


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 103<br />

Code No Product<br />

79V0449 V P VACCINE NOBILIS CLONE 30 POWDER FOR RECONSTITUTION 10-6EID50/DOSE, 1000D<br />

98V0178 V.H. NEWCASTLE DISEASE<br />

78V0014 VACCINE GUMBORO NOBILIS 10-4PFU/DOSE,1000DOS<br />

95V0528 VANGUARD 7 SUSPENSION FOR INJECTION<br />

95V0337 VASTHINOL POWDER<br />

95V0717 VERMITAN SUSPENSION 10%<br />

95V0680 VETRIMOXIN LA SUSPENSION FOR INJECTION 15%<br />

94V0262 VETRIMOXIN ORAL PASTE 2%<br />

94V0261 VETRIMOXIN TABLETS 150MG<br />

99V0102 VIRA SHIELD 5+VL5 INJECTION 10 DOSES, 50ML<br />

85V0369 VITA PUNCH WATER SOLUBLE POWDER<br />

92V0548 VITAMIN ‘FORTE’ AD3E INJECTION 100ML<br />

84V0285 VITAMIN AD3E FORTE INJECTION<br />

94V0542 VITAMIN E LIQUID 10%<br />

93V0180 VITAQUIN 200 ORAL SOLUTION 20%<br />

96V0367 VITASOL MULTI SOLUTION<br />

86V0239 VITESEL SUSPENSION FOR INJECTION 50ML<br />

99V0031 WELPAN ORAL SUSPENSION<br />

98V0181 WINTERFIELD BURSAL DISEASE


EN<br />

104 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Appendix A<br />

referred to in Chapter 4, Section B, Subsection I, point 1 of Annex VIII (*)<br />

List of establishments, including shortcomings and deadlines for the correction of these shortcomings<br />

MILK PROCESSING ESTABLISHMENTS<br />

No Vet. No Name of establishment Shortcomings<br />

1 LV 8060<br />

003<br />

AGM Agro Eksports, Akciju<br />

sabiedrība<br />

Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 2(d), (e), and (g)<br />

Annex B, Chapter I, points 3, 7 and 11<br />

Annex B, Chapter V, point (c)<br />

2 LV 009 P Cesvaines Piens, Akciju sabiedrība Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex B, Chapter I, points 3 and 11<br />

Annex B, Chapter II.A, point 1<br />

Annex B, Chapter V, point (c)<br />

3 Mālpils piensaimnieks, Sabiedrība<br />

ar ierobezˇotu atbildību<br />

4 Dundaga, Piensaimnieku<br />

kooperatīvā sabiedrība<br />

5 Jēkabpils piena kombināts,<br />

Sabiedrība ar ierobezˇotu atbildību<br />

6 Elpa, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

7 Sēlpils, Piensaimnieku kooperatīvā<br />

sabiedrība<br />

8 Edaks, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

(*) For the text of Annex VIII see OJ L 236, 23.9.2003, p. 824.<br />

Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g) and (h)<br />

Annex B, Chapter I, points 3, 7, 11 and 15<br />

Annex B, Chapter V, point (a)<br />

Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (d), (e), (f)<br />

and (g)<br />

Annex B, Chapter I, points 3 and 11<br />

Annex B, Chapter V, points (c) and (f)<br />

Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex B, Chapter I, points 3, 11 and 15<br />

Annex B, Chapter II.A, point 1<br />

Annex B, Chapter V, points (c), (e) and (f)<br />

Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d), (f),<br />

(g) and (h)<br />

Annex B, Chapter I, points 3, 4, 7, 11 and 15<br />

Annex B, Chapter V, points (c) and (f)<br />

Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex B, Chapter I, points 3, 4, 11<br />

and 15<br />

Annex B, Chapter II.A, point 1<br />

Annex B, Chapter V, point (b), (c), (d), (e),<br />

and (f)<br />

Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 2(a), (e) and (g)<br />

Annex B, Chapter I, points 3, 11 and 15<br />

Annex B, Chapter II.A, point 1<br />

Annex B, Chapter V, points (a), (c), (e) and (f)<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 105<br />

No Vet. No Name of establishment Shortcomings<br />

9 Dzilna, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

Council Directive 92/46/EC:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d)<br />

and (g)<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter II.A, point 1<br />

Annex B, Chapter V, point (c)<br />

10 Pumpuri, Zemnieku saimniecība Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 2(d), (g) and (h)<br />

Annex B, Chapter I, points 3, 4, 8 and 11<br />

Annex B, Chapter V, points (c) and (e)<br />

11 LIVI, Zemnieku saimniecība Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d), (g)<br />

and (h)<br />

Annex B, Chapter I, points 3, 9 and 11<br />

Annex B, Chapter II.A, point 1<br />

Annex B, Chapter V, points (c) and (f)<br />

FISH ESTABLISHMENTS<br />

No Vet. Nr. Name of establishment Shortcomings<br />

1 LV 06 Z,<br />

LV 07 Z<br />

Kaija, Akciju sabiedrība Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d)<br />

and (g)<br />

Annex, Chapter IV.I, point 1<br />

2 LV 18 Z Elanders, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

3 LV 57 Z Jūras veltes 2, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

4 LV 101 Z Grif & Ko, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

5 LV 103 Z Unikom Investments, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

6 LV 41 Z Poliko, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d)<br />

and (g)<br />

Annex, Chapter III.I, point 9<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d)<br />

and (g)<br />

Annex, Chapter IV.II, point 3.<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1.<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 2(a), (b), (c), (e)<br />

and (g)<br />

Annex, Chapter III.I, points 3, 5 and 9<br />

Annex, Chapter IV.II, point 3<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004


EN<br />

106 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. Nr. Name of establishment Shortcomings<br />

7 LV 107 Z Baltā zivīte, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 2(c) and (g)<br />

Annex, Chapter III.I, point 3<br />

8 Agaluks, Individuālais uzņēmums Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 2(g)<br />

Annex, Chapter III.I, point 9<br />

9 LV 26 Z Fora, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

10 LV 24 Z Loms un Ko, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

11 LV 05 Z Liepājas ZKK, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

12 LV 34 Z Anglers, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex, Chapter III.I, points 3, 5 and 9<br />

Annex, Chapter IV.II, point 3<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex, Chapter III.I, point 9<br />

Annex, Chapter IV.I, point 1<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex, Chapter III.I, points 3, 5 and 9<br />

Annex, Chapter IV.II, point 3<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex, Chapter III.I, points 5 and 9<br />

Annex, Chapter IV.I, point 1<br />

13 LV 75 Z Kursa, Akciju sabiedrība Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex, Chapter III.I, points 3 and 9<br />

Annex, Chapter IV.II, point 3<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 107<br />

No Vet. Nr. Name of establishment Shortcomings<br />

14 LV 76 Z N-Stars, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

15 Vido, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

16 Ozols H, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex, Chapter III.I, points 3, 5 and 9<br />

Annex, Chapter IV.II, point 3<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex, Chapter III.I, points 5 and 9<br />

Annex, Chapter IV.II, point 3<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex, Chapter III.I, points 5 and 9<br />

17 LV 01 Z Salacgrīva 95, Akciju sabiedrība Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex, Chapter III.I, points 3 and 9<br />

18 LV 03 Z Carnikavas konservi, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

19 LV 02 Z Rojas konservi, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

20 LV 43 Z Senga, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

21 LV 45 Z Sabiles ADK, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 2(a), (b) and (c)<br />

Annex, Chapter III.I, points 3 and 9<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex, Chapter III.I, points 3, 5 and 9<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex, Chapter III.I, points 3, 5 and 9<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex, Chapter III.I, points 3, 5 and 9<br />

Annex, Chapter IV.II, point 3<br />

Annex, Chapter IV, point 4(d)<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004


EN<br />

108 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. Nr. Name of establishment Shortcomings<br />

22 LV 70 Z Līcis-93 G¸ ipkas cehs, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

23 LV 84 Z Rānda, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

24 LV 20 Z Bērzlejas, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

25 LV 88 Z Līcis-93, Kolkas cehs, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex, Chapter III.I, point 9<br />

Annex, Chapter IV.IV, point 4(d)<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex, Chapter III.I, points 3, 5 and 9<br />

Annex, Chapter IV.IV, point 4(d)<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c) and<br />

(g)<br />

Annex, Chapter III.I, points 3 and 9<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex, Chapter III.I, points 3 and 9<br />

Annex, Chapter IV.II, point 3<br />

26 LV 80 Z Mauriņi, Zvejnieku saimniecība Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(b), (c) and (e)<br />

27 LV 55 Z Selga, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

28 LKZ, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

29 LV 98 Z Saldus gal¸as kombināts, Sabiedrība<br />

ar ierobezˇotu atbildību<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d)<br />

and (g)<br />

Annex, Chapter III.I, point 9<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex, Chapter III.I, points 3, 5 and 9<br />

Annex, Chapter IV.II, point 3<br />

Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d)<br />

and (g)<br />

Annex, Chapter III.I, point 9<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 109<br />

MEAT ESTABLISHMENTS<br />

No Vet. No Name of establishment Shortcomings<br />

1 Saldus gal¸as kombināts, Sabiedrība<br />

ar ierobezˇotu atbildību<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e) and<br />

(g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter II, point 14(e)<br />

Annex I, Chapter III, point 15<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Annex I, Chapter XIV, point 68<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex A, Chapter I, points 6 and 11<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter I, point 1(a)<br />

Annex I, Chapter III, point 1(a)<br />

2 Talsu gal¸a, Akciju sabiedrība Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e) and<br />

(g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter II, point 14(e) and (f)<br />

Annex I, Chapter III, point 15<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Annex I, Chapter XIV, point 68<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

Annex B, Chapter II, point 3<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter I, point 1(a)<br />

Annex I, Chapter III, point 1(a)<br />

3 Tukuma gal¸as pārstrādes<br />

sabiedrība, Akciju sabiedrība<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f)<br />

and (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter II, point 14(e) and (f)<br />

Annex I, Chapter III, point 15<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Annex I, Chapter XIV, point 68<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

Annex B, Chapter II, point 3<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter I, point 1(a)<br />

Annex I, Chapter III, point 1(a)<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2005<br />

31.12.2005


EN<br />

110 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of establishment Shortcomings<br />

4 Triāls filiāle ‘Valmieras gal¸as<br />

kombināts’, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

5 Daugavpils gal¸as kombināts R,<br />

Sabiedrība ar ierobezˇotu atbildību<br />

6 Gravendāles receptes, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

7 Gravendāle, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f)<br />

and (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter II, point 14(e) and (f)<br />

Annex I, Chapter III, point 15<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

Annex B, Chapter II, point 3<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter I, point 1(a)<br />

Annex I, Chapter III, point 1(a)<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e) and<br />

(g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter II, point 14(e) and (f)<br />

Annex I, Chapter III, point 15<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

Annex B, Chapter II, point 3<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter I, point 1(a)<br />

Annex I, Chapter III, point 1(a)<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f)<br />

and (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter III, point 15<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, point 11<br />

Annex B, Chapter I, points 1 and 2<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter I, point 1(a)<br />

Annex I, Chapter III, point 1(a)<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e) and<br />

(g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter III, point 15<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, point 11<br />

Annex B, Chapter I, points 1 and 2<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter I, point 1(a)<br />

Annex I, Chapter III, point 1(a)<br />

Date of full<br />

compliance<br />

31.12.2005<br />

31.12.2005<br />

31.12.2005<br />

31.12.2005


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 111<br />

No Vet. No Name of establishment Shortcomings<br />

8 Lagzdiņa KU, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

9 Kolanda, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

10 Putnu fabrika K¸ ekava, Akciju<br />

sabiedrība<br />

11 Valentīna un dēli, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

12 Revanšs, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (e) and (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter III, point 15<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

Annex B, Chapter II, point 3<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter III, point 1(a)<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e) and<br />

(g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter III, point 15<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c) and (g)<br />

Annex A, Chapter I, point 11<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter III, point 1(a)<br />

Council Directive 71/118/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e) and<br />

(g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter II, point 14(b) and 14(c)<br />

Annex I, Chapter V, point 18(d)<br />

Annex I, Chapter VII, point 43<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d)<br />

and (e)<br />

Annex A, Chapter I, point 11<br />

Annex B, Chapter I, points 1 and 2<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter III, point 1(a)<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c) and (e)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

Annex B, Chapter II, point 3<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c) and (e)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d), (e)<br />

and (f)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2004<br />

31.12.2005<br />

31.12.2005<br />

31.12.2004


EN<br />

112 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of establishment Shortcomings<br />

13 Silāres, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

14 Frug, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a) and (c)<br />

Annex II, Chapter I, point 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a) and (c)<br />

Annex A, Chapter I, point 11<br />

Annex B, Chapter I, points 1 and 2<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c) and (e)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d), (e)<br />

and (f)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

Annex B, Chapter II, point 3<br />

15 Svēde, Individuālais uzņēmums Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(b), (c), (d) and (e)<br />

Annex A, Chapter I, point 11<br />

Annex B, Chapter I, points 1 and 2<br />

16 Apšupe, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

17 Praktik BBS, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

18 Erso7, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c) and (f)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Annex II, Chapter II, point 10<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(b), (c), (d) and (f)<br />

Annex A, Chapter I, point 11<br />

Annex B, Chapter I, points 1 and 2<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(b) and (c)<br />

Annex II, Chapter I, point 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(b), (c) and (d)<br />

Annex A, Chapter I, point 11<br />

Annex B, Chapter I, points 1 and 2<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter 1, point 4(a)<br />

Annex II, Chapter 1, point 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(f)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2005<br />

31.12.2005<br />

31.12.2005


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 113<br />

No Vet. No Name of establishment Shortcomings<br />

19 Kas-Kad, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

20 GPC Smārde, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c) and (e)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d), (e)<br />

and (f)<br />

Annex A, Chapter I, point 11<br />

Annex B, Chapter I, points 1 and 2<br />

Annex B, Chapter II, point 3<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (c) and (e)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(b) and (c)<br />

Annex A, Chapter I, point 11<br />

Annex B, Chapter I, points 1 and 2<br />

21 Seguns, Zemnieku saimniecība Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d), (e)<br />

and (f)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

22 Ozols, Akciju sabiedrība Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c) and (e)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d), (e)<br />

and (f)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

Annex B, Chapter II, point 3<br />

23 Agnis, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(b), (c), (e) and (f)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Annex II, Chapter II, point 10<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(b), (c), (d), (e)<br />

and (f)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

24 Strautmal¸i, Zemnieku saimniecība Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c) and (e)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d), (e)<br />

and (f)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

Annex B, Chapter II, point 3<br />

Date of full<br />

compliance<br />

31.12.2005<br />

31.12.2005<br />

31.12.2005<br />

31.12.2005<br />

31.12.2005<br />

31.12.2005


EN<br />

114 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of establishment Shortcomings<br />

25 Bērzlejas, Zemnieku saimniecība Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c) and (e)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b), (c), (e)<br />

and (f)<br />

Annex A, Chapter I, points 6 and 11<br />

Annex B, Chapter I, points 1 and 2<br />

26 Lauksalaca, Akciju sabiedrība Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c), (e)<br />

and (f)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Annex II, Chapter II, point 10<br />

27 Veinils, Sabiedrība ar ierobezˇotu<br />

atbildību<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c), (e)<br />

and (f)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Annex II, Chapter II, point 10<br />

28 Saulgozˇi, Zemnieku saimniecība Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(b)<br />

Annex II, Chapter I, point 9<br />

Annex II, Chapter II, point 10<br />

29 Olan Sami, Sabiedrība ar<br />

ierobezˇotu atbildību<br />

Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c) and (e)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

30 Dragon Council Directive 64/433/EEC:<br />

Annex II, Chapter I, point 1(a), (b), (c) and (e)<br />

Annex II, Chapter I, point 4(a)<br />

Annex II, Chapter I, point 9<br />

Appendix B<br />

referred to in Chapter 4, Section B, Subsection I, point 2 of Annex VIII (*)<br />

Date of full<br />

compliance<br />

31.12.2005<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

31.12.2004<br />

Animal waste processing establishments (including shortcomings and deadlines for the correction of these<br />

shortcomings)<br />

No Name of establishment Shortcomings<br />

1 Triāls Valmieras SH Regulation (EC) 1774/2002:<br />

Annex V, Chapter I, points 1(b), 1(e)(ii), 4<br />

Annex VII, Chapter I, Section C, 8<br />

2 Gauja AB Regulation (EC) 1774/2002:<br />

Annex V, Chapter I, points 1(b), 1(e)(ii), 4<br />

Annex VII, Chapter I, Section C, 8<br />

(*) For the text of Annex VIII see OJ L 236, 23.9.2003, p. 824.<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2004


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 115<br />

Appendix A<br />

referred to in Chapter 1 of Annex IX (*)<br />

List as provided by Lithuania in one language of pharmaceutical products for which a marketing authorisation issued<br />

under Lithuanian law prior to the date of accession shall remain valid until it is renewed in compliance with the acquis<br />

or until 31 December 2006, whichever is the earlier.<br />

Mention on this list does not prejudge whether or not the pharmaceutical product in question has a marketing<br />

authorisation in compliance with the acquis.<br />

LIST OF PHARMACEUTICALS SUBJECT TO TRANSITIONAL PERIOD UNDER CHAPTER 1<br />

No. Commercial name General name<br />

1. 1g Kalio chlorido tirpalui<br />

paruošti<br />

2. 500mg Kalio chlorido tirpalui<br />

paruošti<br />

A. PHARMACEUTICALS FOR HUMAN USE<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

Kalii chloridum tab. 1g N30;N50 Bakteriniai<br />

preparatai<br />

Kalii chloridum tab. 500mg N30;N50 Bakteriniai<br />

preparatai<br />

3. 5-Fluorouracil ‘Ebewe’ Fluorouracilum sol. for inj. 500mg/10ml amp. N5;<br />

250mg/5ml vial N1, 5ml<br />

amp.N5<br />

4. 5-Fluorouracil ‘Ebewe’<br />

500 mg/10 ml<br />

5. 5-Fluorouracil ‘Ebewe’<br />

1 000 mg/20 ml<br />

Fluorouracilum conc. for sol.<br />

for inf.<br />

Fluorouracilum conc. for sol.<br />

for inf.<br />

Ebewe<br />

500mg/10ml vial Ebewe<br />

1 000mg/20ml vial Ebewe<br />

6. 5-NOK Nitroxolinum coated tab. 50mg N50 Lek<br />

7. 750mg Kalio chlorido tirpalui<br />

paruošti<br />

Kalii chloridum tab. 750mg N30;N50 Bakteriniai<br />

preparatai<br />

8. Abaktal 400 mg/5 ml Pefloxacinum sol.for inf. 400mg/5ml amp.N10 Lek<br />

9. Abaktal film-coated tablets<br />

400mg<br />

10. ABC Warme-Pflaster N (Locale<br />

schmerz-therapie)<br />

Pefloxacinum film-coated tab. 400mg N10 Lek<br />

Arnica extractum+ Capsicum<br />

fructescens fructus+ Capsicum<br />

fructescens extractum<br />

11. Abdomilon Extr.herb.Absinthii+<br />

Extr.rad.Angelicae+<br />

Extr.rhiz.Calami+<br />

Extr.cort.Frangulae+<br />

Extr.rad.Gentianae+<br />

Extr.fol.Melissae+<br />

Extr.rhiz.Rhei+Ol. Anisi+<br />

Ol.Carvi+Ol.<br />

Caryophylli+Ol.<br />

Valerianae+<br />

Mentholum+Ol.Citri+<br />

Ol.Chamomillae<br />

transdermal<br />

patch<br />

55mg+ 1,205-1,631g+<br />

72mg/patch (14×22cm) N1;<br />

N2<br />

sol. 0,5g+0,6g+<br />

3g+1g+1g+<br />

1g+ 2,4g+ 20mg+30mg+<br />

20mg+6mg +20mg+2mg+<br />

2mg/100g 100ml<br />

Beiersdorf<br />

12. Abricef Cefotaximum powder for inj. 1g/ bottle N1; N10 Balkan-pharma-<br />

Razgrad<br />

13. Abricef Cefotaximum powder for inj. 2g/bottle N1; N10 Balkan-pharma-<br />

Razgrad<br />

14. Ac.aminocapronicum sol. 5%<br />

inj.<br />

Redel<br />

Acidum aminocapronicum sol. 5% 100ml Liuks<br />

15. Ac.glutaminicum 0,25g Acidum glutaminicum tab. 0,25g N10 Liuks<br />

16. Acard Acidum acetylsalicylicum coated tab. 75mg Polfa Warsaw<br />

(*) For the text of Annex IX see OJ L 236, 23.9.2003, p. 836.


EN<br />

116 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

17. ACC 100 Acetylcysteinum gran.for sol. 100mg/3g<br />

N20<br />

Strength Manufacturer<br />

18. ACC 100 Acetylcysteinum efferv. tab. 100mg N20; N50; N100 Hexal<br />

Salutas<br />

19. ACC 200 Acetylcysteinum gran. for sol. 200mg/3g N20 Salutas<br />

20. ACC 200 Acetylcysteinum efferv. tab. 200mg N20; N50; N100 Hexal<br />

21. ACC akut 200 Acetylcysteinum gran. for oral<br />

sol.<br />

200mg/3g N20 Hexal<br />

22. ACC long Acetylcysteinum efferv.tab. 600mg N10 Salutas<br />

23. ACC Saft Acetylcysteinum syrup 200mg/10ml 75ml;150ml Hexal<br />

24. Accolate Zafirlukastum coated tab. 20mg N28; N56 AstraZeneca<br />

25. Accolate Zafirlukastum coated tab. 40mg N28; N56 Zeneca<br />

26. Accupro 10 Quinaprilum film-coated tab. 10mg N30 Gödecke/ Warner-<br />

Lambert<br />

27. Accupro 20 Quinaprilum film-coated tab. 20mg N30 Gödecke/ Warner-<br />

Lambert<br />

28. Accupro 5 Quinaprilum film-coated tab. 5mg N30 Gödecke/ Warner-<br />

Lambert<br />

29. Accuzide Quinaprilum+<br />

Hydrochlorothiazidum<br />

30. Accuzide 20 Quinaprilum+<br />

Hydrochlorothiazidum<br />

film-coated tab. 10mg+ 12,5mg N30 Gödecke<br />

film-coated tab. 20mg+ 12,5mg N30 Gödecke<br />

31. Acenocumarol Acenocoumarolum tab. 4mg N60 Polfa Warsaw<br />

32. Acetilcisteinas 100 Acetylcysteinum tab. 100 mg N10; N20; N30 Liuks<br />

33. Acetilcisteinas 200 Acetylcysteinum tab. 200 mg N10; N20; N30 Liuks<br />

34. Acetilsalicilo rūgšties<br />

500 mg tablete˙s<br />

35. Acetilsalicilo rūgšties 500mg<br />

tablete˙s<br />

36. Acetilsalicilo rūgšties 500mg<br />

tablete˙s<br />

37. Acetilsalicilo rūgšties ir magnio<br />

tablete˙s<br />

Acidum acetylsalicylicum tab. 500mg<br />

N50; N100<br />

Sanitas<br />

Acidum acetylsalicylicum tab. 500mg N20 KMA vaistine˙<br />

Acidum acetylsalicylicum tab. 500mg<br />

N10; N20; N60<br />

Acidum acetylsalicylicum+<br />

Magnesium<br />

Bakteriniai<br />

preparatai<br />

tab. N30; N50; N100 Liuks<br />

38. Acetilsalicilo rūgštis Acidum acetylsalicylicum tab. 100mg N30;N50; N100 Liuks<br />

39. Acetilsalicilo rūgštis<br />

500 mg MDF<br />

40. Acetilsalicilo rūgštis 250mg ir<br />

Kofeinas<br />

50 mg<br />

Acidum acetylsalicylicum tab. 500mg N10 Medicata filia<br />

Acidum acetylsalicyliccum+<br />

Coffeinum<br />

tab. 250mg+ 50mg<br />

N10<br />

41. Acetilsalicilo rūgštis 500mg Acidum acetylsalicylicum tab. 500mg<br />

N10<br />

42. Acetylcystein ‘Nycomed’<br />

200 mg-Granulat<br />

43. Acetylcystein ‘Nycomed’<br />

100 mg-Granulat<br />

Acetylcysteinum granules for<br />

oral sol.<br />

Acetylcysteinum granules for<br />

oral sol.<br />

Liuks<br />

Liuks<br />

200mg/ sachet N20 Dyna-Pharm<br />

100mg/ sachet N20 Dyna-Pharm


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 117<br />

No. Commercial name General name<br />

44. Acetylcystein 100 Stada<br />

Granulat<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

Acetylcysteinum gran. 100mg/sachets (3g) N20; N50 Stada<br />

45. Acetylcystein 100 Stada Tabs Acetylcysteinum tab. 100mg, N20, N50 Stada<br />

46. Acetylcystein 200 Stada Tabs Acetylcysteinum tab. 200mg; N20, N50 Stada<br />

47. Acetylcystein 200 Stada<br />

Granulat<br />

48. Acetylcystein 600 Stada<br />

Granulat<br />

Acetylcysteinum gran. 200mg/sachets (3g) N20; N50 Stada<br />

Acetylcysteinum gran. 600mg/sachets (3,2g) N10;<br />

N20; N50<br />

49. Acetylcystein 600 Stada Tabs Acetylcysteinum tab. 600mg, N10;N20; N50 Stada<br />

50. Acic 200 Aciclovirum tab. 200mg N25; N100 Hexal<br />

51. Acic 400 Aciclovirum tab. 400mg N35; N70 Hexal<br />

52. Acic 800 Aciclovirum tab. 800mg N35 Hexal<br />

53. Acic creme Aciclovirum cream 50mg/g<br />

2g<br />

Stada<br />

Salutas Pharma<br />

54. Aciclovir Aciclovirum cream 5% 5g; 10g; Balkanpharma-<br />

Troyan AD<br />

55. Aciclovir Aciclovirum tablets 200mg N20 Balkanpharma-<br />

Troyan AD<br />

56. Aciclovir Aciclovirum tablets 400mg N10 Balkanpharma-<br />

Troyan AD<br />

57. Aciclovir Alpharma Tablets<br />

200 mg<br />

58. Aciclovir Alpharma Tablets<br />

400 mg<br />

59. Aciclovir Alpharma Tablets<br />

800 mg<br />

60. Acidanon Magnesii hydroxidum+<br />

Aluminii hydroxidum<br />

Aciclovirum tab. 200mg N30 Alpharma<br />

Aciclovirum tab. 400mg N30 Alpharma<br />

Aciclovirum tab. 800mg N35 Alpharma<br />

oral.susp. 400mg+<br />

370mg/10ml<br />

N20; N30<br />

61. Acidex 150 Ranitidinum film-coated tab. 150mg N50 Sun<br />

62. Acidex 300 Ranitidinum film-coated tab. 300mg N100 Sun<br />

63. Acidin pepsinum Acidin pepsinum tab. N10; N24; N50 Liuks<br />

Slovakofarma<br />

64. Acidum Acetylsalicy-licum Acidum acetylsalicylicum tab. 500mg N10; N20 Tallinna<br />

Farmaatsiatehase<br />

65. Acidum acetylsalicylicum<br />

plius C<br />

Acidum acetylsalicylicum +<br />

Acidum ascorbicum<br />

tab. 250 mg+ 100mg; N20, N30,<br />

N50<br />

Medicata filia<br />

66. Acidum ascorbicum Acidum ascorbicum drag. 50mg N200 Marbiofarm<br />

67. Acidum ascorbicum Acidum ascorbicum subst. 3,5kg Marbiofarm


EN<br />

118 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

68. Acifein Acidum acetylsalicylicum+<br />

Paracetamolum+<br />

Coffeinum<br />

Pharmaceutical<br />

form<br />

tab. 250mg+ 200mg+<br />

50mg<br />

N10<br />

Strength Manufacturer<br />

Slovakofarma<br />

69. Aclotin Ticlopidinum coated tab. 250mg N20 ICN Polfa Rzeszow<br />

70. Acnecolor Clotrimazolum cream-past. 10mg/g 30g Spirig<br />

71. Aco Chondrum Lycopodium clavatum D6+<br />

Secale cornutum D6+ Acidum<br />

silicicum C6+<br />

Argentum nitricum C6+<br />

Acidum phosphoricum D6+<br />

Smilax officinalis D6+<br />

Rhododendron<br />

campylocarpum D6<br />

72. Aco Chondrum Lycopodium clavatum D5 +<br />

Secale cornutum D5+Acidum<br />

silicicum C5+<br />

Argentum nitricum C5+<br />

Acidum phosphoricum D5 +<br />

Smilax officinalis D5+<br />

Rhododendron campylocarpum<br />

D5<br />

73. Aco Femum Sepia officinalis C6 + Lachesis<br />

mutus C6 + Sanguinaria<br />

canadensis C6 + Cimicifuga<br />

racemosa D6 + Hamamelis<br />

virginiana D6 + Strychos<br />

ignatii C6<br />

74. Aco Femum Sepia officinalis C5 +Lachesis<br />

mutus C5+Sanguinaria<br />

canadensis C5 +Cimicifuga<br />

racemosa D5 +Hamamelis<br />

virginiana D5+ Strychnos<br />

ignatii C5<br />

75. Aco Optum Apis mellifica D6+<br />

Euphrasia officinalis D6+<br />

Kalium bichromicum D6+<br />

Acidum silicicum C6+Atroppa<br />

belladonna D6+Secale<br />

cornutum D6+Colchicum<br />

autumnale D6+Pulsatilla<br />

pratensis D6+Nicotiana<br />

tabacum D6<br />

76. Aco Optum Apis mellifica D5+<br />

Euphrasia officinalis D5 +<br />

Kalium bichromicum D5+<br />

Acidum silicicum C5 +Atropa<br />

belladonna D5 +Secale<br />

cornutum D5+ Colchicum<br />

autumnale D5+<br />

Pulsatilla pratensis D5+<br />

Nicotiana tabacum D5<br />

77. Aco Prostum Thuja occidentalis D6 +<br />

Selenium amorphum C6 +<br />

Conium maculatum D6 +<br />

Argentum nitricum C6 +<br />

Aurum metalicum C6+<br />

Lachesis mutus C6<br />

+Rhododendron<br />

campylocarpum D6+<br />

Apis mellifica D6<br />

oral drops 10mg+10mg+1mg+ 1mg+<br />

10mg+10mg+10mg/g<br />

(Ethanolum<br />

36 % (V/V)) 20ml<br />

tab. 100mg+<br />

100mg+<br />

10mg+<br />

10mg+<br />

100mg+<br />

100mg+<br />

100mg/g<br />

N30; N50; N60<br />

oral drops 1mg+1mg+<br />

1mg+10mg+<br />

10mg+1mg/g (Ethanolum<br />

38 % (V/V)) 20ml<br />

tab. 10mg+10mg+<br />

10mg+100mg+<br />

100mg+<br />

10mg/g<br />

N30; N50; N60<br />

oral drops 10mg+10mg+10mg+1mg+<br />

10mg+<br />

10mg+<br />

10mg+10mg+10mg/g<br />

(Ethanolum<br />

38 % (V/V)) 20ml<br />

tab. 100mg+<br />

100mg+<br />

100mg+10mg+100mg+<br />

100mg+<br />

100mg+<br />

100mg+<br />

100mg/g<br />

N30; N50; N60<br />

oral drops 10mg+1mg+<br />

10mg+1mg+<br />

1mg+1mg+<br />

10mg+10mg/g (Ethanolum<br />

33 % (V/V)) 20ml<br />

Aconitum<br />

Aconitum<br />

Aconitum<br />

Aconitum<br />

Aconitum<br />

Aconitum<br />

Aconitum


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 119<br />

No. Commercial name General name<br />

78. Aco Prostum Thuja occidentalis D5+<br />

Selenium amorphum C5+<br />

Conium maculatum D5+<br />

Argentum nitricum C5+Aurum<br />

metalicum C5+<br />

Lachesis mutus C5 +<br />

Rhododendron<br />

campylocarpum D5 +Apis<br />

mellifica D5<br />

Pharmaceutical<br />

form<br />

tab. 100mg+<br />

10mg+<br />

100mg+<br />

10mg+10mg+10mg+<br />

100mg+ 100mg/g<br />

N30; N50; N60<br />

Strength Manufacturer<br />

Aconitum<br />

79. Aco-Belladonna Atropa Belladonna C6 oral drops 0,001g 20ml Aconitum<br />

80. Aco-Calendula Calendula officinalis D3 oral drops, sol 0,01g/g (Ethanolum 38%)<br />

20ml<br />

81. Acocordilum Adonis vernalis D5+Cactus<br />

grandiflorus D4 +Aurum<br />

chloratum natronatum C6 +<br />

Crataegus oxyacantha o +<br />

Kalium carbonicum C3 +<br />

Glonoinum C5<br />

82. Acocordilum Adonis vernalis D4+ Cactus<br />

grandiflorus D3+Aurum<br />

chloratum natronatum C5+<br />

Crataegus oxyacantha ø+<br />

Kalium carbonicum C2+<br />

Glonoinum C4<br />

oral drops, sol 0,01g+0,01g+0,001g+ 0,01g+<br />

0,001g+ 0,001g/g (Ethanolum<br />

15 % iki 1g) 20ml; 30ml; 50ml<br />

tab. 100mg+<br />

100mg+10mg+10mg+ 10mg+<br />

10mg/g<br />

N30; N50; N60<br />

83. Aco-Crataegus Crataegus laevigata D3 oral drops, sol 0,01g/g (Ethanolum 36%)<br />

20ml<br />

84. Acodentin Mercurius solubilis<br />

hahnemanni C5+ Phytolacca<br />

americana D5 + Acidum<br />

nitricum C5<br />

85. Acodol Echinacea purpurea ø+<br />

Hamamelis virginiana ø+<br />

Hypericum perforatum D4 +<br />

Calendula officinalis ø+ Arnica<br />

montana D2+ Bellis perennis<br />

D2+ Ruta graveolens D4+<br />

Symphytum officinalis D2<br />

Ledum palustris D4+ Atropa<br />

belladonna D2 + Rhus<br />

toxicodendron D2<br />

86. Acodoril Thymus vulgaris ø+ Mentha<br />

piperitta ø+ Myrrhis<br />

odorata D3<br />

pasta 0,5mg+10mg+0,5mg/g<br />

30g; 50g<br />

ointment 10mg+10mg+ 0,5mg+ 10mg+<br />

10mg + 10mg+ 0,5mg+1mg+<br />

0,5mg+ 1mg+1mg/g<br />

30g; 50g<br />

pasta 10mg+10mg+10mg/g<br />

30g; 50g<br />

87. Aco-Echinacea Echinacea purpurea D3 oral drops, sol 0,01g/g (Ethanolum 38%)<br />

20ml<br />

88. Aco-Echinacea Echinacea purpurea D2 tab. 100mg/g<br />

N30; N50; N60<br />

89. Acogalphirin Galphimia glauca C6 nasal spray 1mg/g<br />

20ml<br />

90. Acogripdilum Bryonia alba D4+Atropa<br />

belladonna D4+Eucalyptus<br />

globulus D3+Sambucus nigra<br />

D3+Pulsatill pratensis D4<br />

91. Acogripdilum Bryonia alba D3+ Atropa<br />

belladonna D3+Eucalyptus<br />

globulus D2+ Sambucus nigra<br />

D2+Pulsatilla pratensis D3<br />

oral drops, sol 0,01g+0,01g+0,01g+0,01g+<br />

0,01g/g (Ethanolum 15% iki<br />

1 g) 20ml; 30ml; 50ml<br />

tab. 100mg+<br />

100mg +100mg+<br />

100mg+<br />

100mg/g<br />

N30; N50; N60<br />

Aconitum/<br />

Norfachema<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum


EN<br />

120 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

92. Aco-Ignatia Strychnos ignatia C6 oral drops, sol 0,001g/g (Ethanolum 36%)<br />

20ml<br />

93. Aco-Ignatia Strychnos ignatii C5 tab. 10mg/g<br />

N30; N50; N60<br />

Strength Manufacturer<br />

94. Aco-Lycopodium Lycopodium clavatum C6 oral drops 1mg/g (Ethanolum 36% (V/V))<br />

20ml<br />

95. Aco-Lycopodium Lycopodium clavatum C5 tab. 10mg/g<br />

N30; N50; N60<br />

96. Acomininum Ignatia amara C3+Atropa<br />

belladonna D4 + Rhus<br />

toxicodendron D4+Arnica<br />

montana D3 + Sulfur C3 +<br />

Bryonia alba D4<br />

97. Acomininum Ignatia amara C2+ Atropa<br />

belladonna D3+ Rhus<br />

toxicodendron D3+ Arnica<br />

montana D2 +Sulfur C2+<br />

Bryonia alba D3<br />

drops, sol 1mg+10mg+10mg+10mg+<br />

1mg+ 10mg/g (15%<br />

Ethanolum iki 1g) 20ml; 30ml;<br />

50ml<br />

tab. 10mg+100mg+ 100mg+<br />

100mg+10mg+ 100mg/g<br />

N30; N50; N60<br />

98. Aco-Myristica Myristica fragrans D3 oral drops, sol 0,01g/g (Ethanolum 36%)<br />

20ml<br />

99. Aco-Myristica Myristica fragrans D2 tab. 100mg/g<br />

N30; N50; N60<br />

100. Aconervin Hypericum perforatum D3 oral drops 10mg/g (Ethanolum 38%<br />

(V/V)) 20ml<br />

101. Aconervin Hypericum perforatum D2 tab. 100mg/g<br />

N30; N50; N60<br />

102. Aco-Nux Vomica Strychnos nux vomica C6 oral drops, sol 0,001g/g (Ethanolum 36%)<br />

20ml<br />

103. Aco-Nux vomica Strychnos nux vomica C5 tab. 10mg/g<br />

N30; N50; N60<br />

104. Acoplex Calotropis gigantea D5 +<br />

Phytolacca decandra D5+<br />

Fucus vesiculosus D5 +<br />

Anistolochia clematis D5<br />

105. Acoplex Calotropis gigantea D5 +<br />

Phytolacca decandra D5+<br />

Fucus vesiculosus D5+<br />

Aristolochia clematis D5<br />

106. Acorininum Calcium sulfuricum C6 +<br />

Acidum silicicum C6+Kalium<br />

jodatum C6 +Mercurium<br />

solubilis C6+Phytolacca<br />

americana D3 +Atropa<br />

belladonna D4 +Pulsatilla<br />

pratensis D4+Thuja<br />

occidentalis D2 +Alium<br />

cepaC6<br />

107. Acorininum Calcium sulfuricum C5+<br />

Acidum silicicum C5+ Kalium<br />

jodatum C5 +Mercurium<br />

solubilis C5+ Phytolacca<br />

americana D2+ Atropa<br />

belladonna D3+ Pulsatilla<br />

pratensis D3+ Thuja<br />

occidentalis D2+ Alium cepa<br />

C5<br />

tab. 100mg+<br />

100mg+<br />

100mg+<br />

100mg/g<br />

N30; N50; N60<br />

oral drops 100mg+<br />

100mg+ 100mg+<br />

100mg/g<br />

20ml; 50ml<br />

drops, sol 1mg+1mg+ 1mg+1mg+<br />

10mg+10mg+10mg+ 10mg+<br />

1mg/g (15% Ethanolum iki<br />

1 g) 20ml;30ml; 50ml<br />

tab. 10mg+10mg+10mg+ 10mg+<br />

100mg+<br />

100mg+<br />

100mg+ 100mg+ 10mg/g<br />

N30; N50; N60<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 121<br />

No. Commercial name General name<br />

108. Acosarum Aconitum napellus D5 +<br />

Arnica montana D3+ Atropa<br />

belladonna D4 + Bryonia alba<br />

D4 + China-Cinchona<br />

succirubra D3 + Nux vomica<br />

D4<br />

109. Acosarum Aconitum napellus D4 +<br />

Arnica montana D2+Atropa<br />

belladonna D3+Bryonia alba<br />

D3+China-Cinchona<br />

succirubra D2+<br />

Nux vomica D3<br />

110. Acosedum Valeriana officinalis Ø +<br />

Ignatia amara C3 +Camphora<br />

C3 +Aurum chloratum<br />

natronatum C6 +Castus<br />

grandiflorus D4<br />

111. Acosedum Valeriana officinalis ø +Ignatia<br />

amara C2+ Camphora C2+<br />

Aurum chloratum natronatum<br />

C5+ Cactus grandiflorus D3<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

oral drops, sol 0,01g+0,01g+0,01g+ 0,01g+<br />

0,01g+0,01g/g (Ethanolum<br />

15% iki 1g) 20ml; 30ml; 50ml<br />

tab. 100mg+<br />

100mg+<br />

100mg+ 100mg+ 100mg+<br />

100mg/g<br />

N30; N50; N60<br />

drops, sol 10mg+1mg+1mg+1mg+ 10mg<br />

(15% Ethanolum iki 1g) 20ml;<br />

30ml; 50ml<br />

tab. 100mg+10mg+ 10mg+10mg+<br />

100mg/g<br />

N30; N50; N60<br />

112. Acoseptin Myristica sebifera D5 tab. 100mg/g<br />

N30; N50; N60<br />

113. Acoseptin Myristica sebifera D5 oral drops 100mg/g<br />

20ml; 50ml<br />

114. Aco-Silicea Acidum silicicum (Silicea) C6 oral drops 0,001g/g (Ethanolum<br />

36 % (V/V)) 20ml<br />

115. Aco-Silicea Acidum silicicum (Silicea) C5 tab. 10mg/g<br />

N30; N50; N60<br />

116. Acoskin Graphites D6+ Selenium<br />

amorphum D10 +Antimonium<br />

crudum D10 +Natrium<br />

chloratum D10+ Mercurius<br />

bijodatus D10 + Pulsatilla<br />

pratensis D10+ Kalium<br />

bromatum D4+ Acidum<br />

silicicum D4+ Sulfur jodatum<br />

D10<br />

ointment 10mg+10mg+ 10mg+ 10mg+<br />

10mg +10mg+ 10mg+10mg+<br />

10mg/g<br />

30; 50g<br />

117. Aco-Thuja Thuja occidentalis C6 oral drops, sol 0,001g/g (Ethanolum 36%)<br />

20ml<br />

118. Aco-Thuja Thuja occidentalis C5 tab. 10mg/g<br />

N30; N50; N60<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

Aconitum<br />

Aconitum/<br />

Norfachema<br />

Aconitum<br />

119. Acotinum homeop. solution 10ml Ethanolum 30% (V/V) Aconitum UAB<br />

120. Acotinum Lycopodium clavatum D5+<br />

Nicotiana tabacum D5+Nux<br />

vomica D5 +Plantago major<br />

D5<br />

tab. 100mg+<br />

100mg+ 100mg+<br />

100mg/g<br />

N30; N50; N60<br />

121. Acotraumil Arnica montana C6 oral drops, sol 0,001g/g (Ethanolum 36 %)<br />

20ml<br />

122. Acotraumil Arnica montana C5 tab. 10mg/g<br />

N30; N50; N60<br />

123. Act-HIB Haemophilus influenze B<br />

conjugatum et anatoxinum<br />

tetani<br />

powder and<br />

diluent for sol.<br />

for inj.<br />

10µg/single dose vial+0,5ml<br />

syringe of diluent (4% sodium<br />

chloride sol.) N1<br />

Aconitum<br />

Aconitum<br />

Aconitum<br />

Pasteur Merieux


EN<br />

122 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

124. Actifed DM Dextromethorphanum+<br />

Pseudoephedrinum+<br />

Triprolidinum<br />

125. Actifed Expectorant Triprolidinum+<br />

Pseudoephedrinum+<br />

Guaifenesinum<br />

126. Actifed sirupas Triprolidinum+<br />

Pseudoephedrinum<br />

Pharmaceutical<br />

form<br />

127. Actilyse Alteplasum powder and<br />

solvent for sol.<br />

for inj.<br />

sir. 10mg+30mg+1,25mg/5ml<br />

100ml<br />

syrup 1,25mg+30mg+100mg/<br />

5ml 30ml;100ml<br />

Strength Manufacturer<br />

Wellcome<br />

Foundation<br />

Glaxo<br />

sir. 1,25mg+30mg/5ml 100ml Wellcome<br />

Foundation<br />

50mg/vial+ 50ml water for inj.<br />

N1<br />

Boehringer<br />

Ingelheim<br />

128. Activelle Estradiolum+ Norethisteronum film-coated tab. 1mg+ 0,5mg N28 Novo Nordisk<br />

129. Actonel 30 mg Natrii risedronas film-coated tab. 30mg N28 OSG Norwich/<br />

Procter & Gamble<br />

130. Actonel 35mg karta˛ per<br />

savaite˛<br />

Natrii nisedronas film-coated<br />

tablets<br />

35mg N1;N2; N4; N10; N12;<br />

N16<br />

Procter & Gamble<br />

Pharmaceuticals<br />

Germany GmbH<br />

131. Actonel 5 mg Natrii risedronas film-coated tab. 5mg N28 OSG Norwich/<br />

Procter & Gamble<br />

132. Actos Pioglitazonum tab. 15mg<br />

N28<br />

133. Actos Pioglitazonum tab. 30mg<br />

N28<br />

134. Actos Pioglitazonum tab. 45mg<br />

N28<br />

135. Actrapid HM Penfill Insulinum humanum sol. for inj. 100IU (3,5mg)/ml cartridge<br />

3ml N5<br />

136. Actrapid HM Penfill Insulinum humanum sol. for inj. 100IU (3,5mg)/ml cartridge<br />

1,5ml N5<br />

137. Actrapid InnoLet Insulinum humanum<br />

recombinatum<br />

monocomponentum (Insulini<br />

injectio neutralis)<br />

Takeda/<br />

Lilly<br />

Takeda/<br />

Lilly<br />

Takeda/<br />

Lilly<br />

Novo Nordisk<br />

Novo Nordisk<br />

sol. for inj. 100IU/ml 3ml cartridge N5 Novo Nordisk<br />

138. Actrapid NovoLet Insulinum humanum sol. for inj. 100IU/ml 3ml cartridge N5 Novo Nordisk<br />

139. Acyclostad Aciclovirum cream 50mg/g 2g Stada<br />

140. Acyclovir Stada Aciclovirum cream 50mg/g<br />

5g; 20g<br />

141. Adamon SR 100 Tramadoli hydrochloridum prolongedrelease<br />

caps.,<br />

hard<br />

142. Adamon SR 150 Tramadoli hydrochloridum prolongedrelease<br />

caps.,<br />

hard<br />

143. Adamon SR 200 Tramadoli hydrochloridum prolongedrelease<br />

caps.,<br />

hard<br />

144. Adamon SR 50 Tramadoli hydrochloridum prolongedrelease<br />

caps.,<br />

hard<br />

Stada<br />

100mg N10;N20; N30 Temmler Pharma<br />

150mg<br />

N10; N20;N30<br />

Temmler Pharma<br />

200mg N10;N20;N30 Temmler Pharma<br />

50mg N10;N20;N30 Temmler Pharma


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 123<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

145. Adenocor Adenosini phosphas sol. for inj. 6mg/2ml Sanofi Winthrop<br />

146. Adenosin ‘Ebewe’ Adenosinum sol. for inj. 3mg/ml 2ml amp. N6 Ebewe<br />

147. Adiuretin Desmopressinum nasal drops, sol. 0,1mg/ml<br />

5ml<br />

Ferring-Lečiva<br />

148. Adiuretin-SD Desmopressinum sol. for inj. 4µg/ml 1ml amp. N5 Ferring-Lečiva<br />

149. Adrenalinum 0,1% Epinephrinum sol. for inj. 1mg/ml 1ml amp. N10 Polfa Warsaw<br />

150. Adriblastina PFS Doxorubicinum sol. for inj. 10mg/5ml vial N1 Pharmacia & Upjohn<br />

Nerviano<br />

151. Adriblastina PFS Doxorubicinum sol. for inj. 50mg/25ml vial N1 Pharmacia & Upjohn<br />

Nerviano<br />

152. Adriblastina Rapid Dissolution Doxorubicinum powder for sol.<br />

for inj.<br />

153. Adriblastina Rapid Dissolution Doxorubicinum powder for sol.<br />

for inj.<br />

154. Adrufyt (Adrufitas) Extr.cort.Salicis sicc.+Extr.rad.<br />

Harpagophyti sicc. +Extr.cort.<br />

Traxini sicc.+ Extr.Solani<br />

dulcamara+ Glucosamini<br />

hydrochloridum+Rutosidum+<br />

Taurinum<br />

50mg/vial N1 Pharmacia & Upjohn<br />

10mg/vial N1 Pharmacia & Upjohn<br />

caps. 140mg+ 75mg+ 50mg+<br />

50mg+ 50mg+ 40mg+ 25mg<br />

N40<br />

155. Advantan kremas Methylprednisoloni aceponas cream 1mg/g<br />

15g<br />

156. Advantan tepalas Methylprednisoloni aceponas ointment 1mg/g<br />

15g<br />

157. Advil Ibuprofenum film-coated tab. 200mg<br />

N10; N20; N30; N50; N100<br />

158. Advil Cold Ibuprofenum+<br />

Pseudoephedrinum<br />

film-coated tab. 200mg+30mg N10; N20; N30;<br />

N50; N100<br />

159. A-E-Mulsin forte Retinolum+ Tocopherolum oral emuls. 16,5mg (30000IU)+<br />

75mg(75IU)/g 50g; 100g<br />

160. A-E-Mulsin fortissimum Retinolum+ Tocopherolum oral emuls. 16,5mg (30000IU)+ 220,58mg<br />

(300IU)/g 50g<br />

161. A-E-Mulsin N Retinolum+ Tocopherolum oral emuls. 3,025mg (5500IU)+<br />

75mg(75IU)/g 50g; 100g<br />

Arco-Chemie<br />

Schering<br />

Schering<br />

Wyeth<br />

Wyeth<br />

Mucos Pharma<br />

Mucos Pharma<br />

Mucos Pharma<br />

162. Aerius Desloratadinum syrup 0,5mg/ml 60ml Schering-Plough<br />

Labo N.V.<br />

163. Aerius 5 mg Desloratadinum film-coated tab. 5mg N10;N30 Schering-Plough<br />

164. Aesculus compositum compos. drops 30ml; 100ml Heel<br />

165. Aescusan Hippocastani extractum<br />

siccum+Thiamini<br />

hydrochloridum<br />

oral sol. (5,00-6,25)g+0,5g/100g<br />

20ml<br />

166. Aescuven forte Extr. sem. Hippocastani sicc. drag. 150mg N40; N100 Redel<br />

167. Aflubin Gentiana D1+ Aconitum D6+<br />

Bryonia D6+ Ferrum<br />

phosphoricum D12+ Acidum<br />

sarcolacticum D12 (Ethanolum<br />

43% 0,59ml/ml)<br />

oral drops, sol. 0,01ml+ 0,1ml+ 0,1ml+<br />

0,1ml+ 0,1ml/ml 20ml;50ml;<br />

100ml<br />

Wernigerode<br />

Richard Bittner


EN<br />

124 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

168. Agapurin Pentoxifyllinum coated tab. 100mg<br />

N60<br />

169. Agapurin 600 retard Pentoxifyllinum slow-release<br />

tab.<br />

Strength Manufacturer<br />

Slovakofarma<br />

600mg N20 Slovakofarma<br />

170. Agapurin injections Pentoxifyllinum sol.for inj. 20mg/ml 5ml amp. N5 Slovakofarma<br />

171. Agapurin retard Pentoxifyllinum coated tab. 400mg<br />

N20<br />

172. Agen 10 Amlodipinum tab. 10mg N30 Lečiva<br />

173. Agen 5 Amlodipinum tab. 5mg N30 Lečiva<br />

174. Agenerase 150 mg soft<br />

capsules<br />

Amprenavirum caps., soft 150mg<br />

N240<br />

175. Agenerase 50 mg soft capsules Amprenavirum caps., soft 50mg<br />

N480<br />

Slovakofarma<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

176. Agenerase oral solution Amprenavirum oral sol. 15mg/ml 240ml Glaxo Wellcome<br />

177. Aggrastat Tirofibanum conc. for sol.<br />

for inf.<br />

178. Agiolax Seeds of Plantago ovata+<br />

Ispaghula husk+ Tinnevelly<br />

senna pods 10-13<br />

0,25mg/ml 50ml MSD<br />

gran. 52g+2,2g+ 15g 100g; 250g Madaus<br />

179. Agiolax Pico Natrii picosulfas lozen-ges 5mg N10; N20; N40 Madaus<br />

180. Agnucaston Extr.Vitex Agni<br />

casti e fruct. spir. sicc.(2:1)<br />

181. Agnucaston Extr.Vitex Agni casti e fruct.<br />

spir. sicc.(2:1)<br />

oral drops, sol. 1,2mg/100g; 50ml; 100ml;<br />

150ml<br />

film-coated tab. 20mg<br />

N30; N60;N100<br />

Plantamed<br />

Plantamed<br />

182. Ajero šakniastiebiai Rhiz. Calami herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

183. Ajeru˛ šakniastiebiai (smulkinti) Rhizomata Acoris calami herbal tea 100g Švenčioniu˛<br />

vaistazˇole˙s<br />

184. Akatinol Memantine Memantinum sol. for inj. 10mg/2ml amp. N5 Merz+Co<br />

185. Akatinol Memantine Memantinum film-coated tab. 10mg N30;N50;N90 Merz+Co<br />

186. Akatinol Memantine Memantinum oral drops, sol. 10mg/ml 50ml;100ml Merz+Co<br />

187. Akilen Verapamilum film-coated tab. 40mg N100 Medochemie<br />

188. Akindex Syrup Adults Dextromethorphani<br />

hydrobromidum<br />

189. Akindex Syrup Children Dextromethorphani<br />

hydrobromidum<br />

syrup 133mg/100ml 200ml Urgo<br />

syrup 100mg/100ml 125ml Urgo<br />

190. Akineton Biperideni lactas sol. for inj. 5mg/ml<br />

1ml amp. N5<br />

191. Akineton Biperideni hydrochloridum tab. 2mg<br />

N100<br />

192. Akineton retard Biperidenum tab. 4mg<br />

N30<br />

193. Akne BP 5 Benzoylis peroxidum emuls. 50mg/ml 55ml Spirig<br />

Knoll<br />

Knoll<br />

Knoll


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 125<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

194. Aknefug — simplex Hexachlorophenum cream 0,5g/100g 18g Wolff<br />

195. Aknefug-EL Erythromycinum sol. for external<br />

use<br />

1g/100ml 25ml;60ml Wolff<br />

196. Aknefug-oxid mild 10% Benzoylis peroxidum gel 10g/100g 25g; 50g Wolff<br />

197. Aknefug-oxid mild 3% Benzoylis peroxidum gel 3g/100g 25g; 50g Wolff<br />

198. Aknefug-oxid mild 5% Benzoylis peroxidum gel 5g/100g 25g; 50g Wolff<br />

199. Aktyvinta anglis 250mg Carbo activatus tab. 250mg N10 Leksredstva<br />

200. Aktyvintos anglies tablete˙s Carbo actyvatus tab. 0,25 g N10 Liuks<br />

201. Alax Aloe pulv.+Frangulae cort.extr.<br />

sicc.+Frangulae cort.pulv.+<br />

Glycyrrhizae rad.pulv.+<br />

Belladonnae rad.pulv.<br />

film-coated tab. 100mg+63,8mg+60mg+<br />

60mg+18,75mg N20<br />

202. Alcaine 0,5 % Proxymetacainum eye drops, sol. 5mg/ml<br />

15ml<br />

Herbapol<br />

Alcon-Couvreur<br />

203. Aldactone Kalii canrenoas sol. for inj. 200mg/10ml N1; N10 Boehringer<br />

Mannheim<br />

204. Alemoxan Clozapinum tab. 50mg N50; N100; N500 AWD<br />

205. Alergamons Chlorphenaminum syrup 2mg/5ml 100ml Grindeks<br />

206. Aleve Naproxenum coated tablets 220mg N10 F.Hoffmann-La<br />

Roche Ltd.<br />

207. alfa-Tocoferolio acetato<br />

(Vitamino E) 30 % aliejinis<br />

tirpalas<br />

208. Algesal Suractive Acidum salicylicum+<br />

Diethylaminum+ Myrtecainum<br />

209. Alka-Prim Acidum acetylsalicylicum+<br />

Glycinum<br />

Tocopherolum sol.oleosa 300mg/ml 20ml Sanitas<br />

cream 6,54g+3,46g+1g/100g<br />

40g<br />

210. Alka-Seltzer Acidum acetylsalicylicum efferv. tab. 324mg<br />

N10<br />

211. Alkeran Melphalanum coated tab. 2mg<br />

N25<br />

212. Alkeran Melphalanum coated tab. 5mg<br />

N25<br />

213. Alkeran Melphalanum powder and<br />

solvent for sol.<br />

for inj.<br />

Solvay Pharma<br />

efferv. tab. 330mg+ 100mg N10 Polpharma<br />

50mg/vial+<br />

10ml amp. of solvent-diluent<br />

(Propylene glycol 60%+<br />

Sodium citrate<br />

+Ethanol)<br />

Bayer Bitterfeld/<br />

Bayer Pharma<br />

Wellcome<br />

Wellcome<br />

Wellcome<br />

Foundation<br />

214. Allergodil Eye Drops Azelastinum eye drops, sol. 5mg/10ml 6ml; 10ml Asta Medica<br />

215. Allergodil Nasal Spray Azelastinum nasal spray, sol. 0,14mg/0,14ml 10ml Asta Medica<br />

216. Allertec Cetirizinum film-coated<br />

tablets<br />

217. Allithera Ol.Allium sativum et<br />

Ol.Oenotherae 1:1<br />

caps. 500mg<br />

N10<br />

10mg N7;N10; N20 Warsaw<br />

Pharmaceutical<br />

Works Polfa<br />

Biogal


EN<br />

126 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

218. Allopurinol Alpharma Tablets<br />

100 mg<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

Allopurinolum tab. 100mg N50; N100 Alpharma<br />

219. Allopurinol-ratiopharm 100 Allopurinolum tab. 100mg N50 Merckle<br />

220. Allopurinol-ratiopharm 300 Allopurinolum tab. 300mg N20;N50 Merckle<br />

221. Allvoran S Diclofenacum natricum supp. 100mg<br />

N10<br />

222. Allvoran S 50 Diclofenacum natricum supp. 50mg<br />

N10<br />

223. Allvoran SF Diclofenacum natricum sol.for inj. 75mg/3ml amp. N30 TAD<br />

224. Almagel Aluminii oxidum+Magnesii<br />

oxidum<br />

225. Almagel A Aluminium hydroxide+<br />

Magnesium hydroxide+<br />

Benzocaine<br />

226. Almagel Neo Aluminii oxidum hydricum+<br />

Magnesii hydroxidum+<br />

Simeticonum<br />

<strong>227</strong>. Almagel Neo Aluminii oxidum hydricum+<br />

Magnesii hydroxidum+<br />

Simeticonum<br />

228. Almaphil 400 Aliuminium oxid, Magnesium<br />

hydroxid<br />

229. Almol Magnesii hydroxidum+<br />

Aluminii hydroxidum<br />

TAD<br />

TAD<br />

oral susp. 218mg+ 75mg/5ml 170ml Balkanpharma-<br />

Troyan<br />

oral susp. 4%+1,38%+<br />

2% 170ml<br />

oral susp. 680mg+<br />

790mg+72mg/10ml<br />

(Ethanolum 226mg/10ml)<br />

10ml N20<br />

oral susp. 340mg+<br />

395mg+36mg/5ml (Ethanolum<br />

113mg/5ml) 170ml; 200ml<br />

tab. N10; N20; N30; N40; N50;<br />

N60; N100<br />

TroyaPharm<br />

Balkanpharma-<br />

Troyan<br />

Balkanpharma-<br />

Troyan<br />

Liuks<br />

oral susp. 200mg+ 225mg/5ml 355ml Perrigo<br />

230. Alocholis Allocholum tab. N50 Liuks<br />

231. Aloes extr. fluidum pro inj.<br />

1ml<br />

Extr. Aloes flud. sol. N10 Liuks<br />

232. Alomide Lodoxamidum eye drops 1mg/ml 5ml; 10ml Alcon-Couvreur<br />

233. Alopurinolis Allopurinolum tab. 0,1g N50 Liuks<br />

234. Alpha D3-Teva Alfacalcidolum drops 0,25µg/drops 5ml Teva<br />

235. Alpha D3-Teva Alfacalcidolum caps. 0,25µg N50 Teva<br />

236. Alpha D3-Teva Alphacalcidolum capsules, soft 1µg N10 Teva Pharmaceutical<br />

Industries Ltd.<br />

237. Alphosyl 2 in 1 Shampoo Alcoholic extract of coal tar shampoo 5%<br />

125ml<br />

238. Alphosyl Cream Allantoin+<br />

Alcoholic extract of coal tar<br />

239. Alphosyl HC Cream Alcoholic extract of coal tar+<br />

Allantoin +Hydrocortisone<br />

240. Alphosyl Lotion Allantoin+<br />

Alcoholic extract of coal tar<br />

cream 2%+5%<br />

100g<br />

cream 5%+2%+<br />

0,5% 30g<br />

Stafford-Miller/<br />

Universal Products<br />

(Lytham)<br />

Stafford-Miller/<br />

Universal Products<br />

(Lytham)<br />

Stafford-Miller/<br />

Universal Products<br />

(Lytham)<br />

lotion 2%+5% 250ml Stafford-Miller/<br />

Universal Products<br />

(Lytham)


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 127<br />

No. Commercial name General name<br />

241. Alpicort Prednisolonum+ Acidum<br />

salicylicum<br />

242. Alpicort F Prednisolonum+ Acidum<br />

salicylicum + Estradiolum<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

sol. 0,2g+ 0,4g/100ml Wolff<br />

sol. 0,2g+0,4g+5mg/100ml 100ml Wolff<br />

243. Alprax-0,25 Alprazolamum tablets 0,25mg N400 Torrent<br />

Pharmaceuticals Ltd.<br />

244. Alprax-0,5 Alprazolamum tablets 0,5mg N30 Torrent<br />

Pharmaceuticals Ltd.<br />

245. Alprax-1 Alprazolamum tablets 1mg N200 Torrent<br />

Pharmaceuticals Ltd.<br />

246. Altiazem RR Diltiazemum (Diltiazemi<br />

resinas)<br />

caps. 180mg N20 Instituto Luso<br />

Farmaco<br />

247. Altiva 120 Fexofenadinum tab. 120mg N100 Ranbaxy<br />

248. Altiva 180 Fexofenadinum tab. 180mg N100 Ranbaxy<br />

249. Alugastrin Dihydroxy-Aluminium-<br />

Natrium carbonicum<br />

250. Alumag Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

251. Alumag Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

252. Alustal Freeze-dried allergen extract modified release<br />

injectable<br />

suspension<br />

susp. 680mg/10ml 250ml Polfa-Lodz<br />

tab. 200mg+200mg N30 Polfa Grodzisk<br />

oral susp. 230mg+ 407,7mg/10ml<br />

250ml<br />

Polfa Grodzisk<br />

0,01-0,1-10 IR/ml or IC/ml Stallergenes S.A.<br />

253. Alveofact Phospholipids susp. for inst. 54mg/1,2ml vial N1 Boehringer<br />

Ingelheim<br />

254. Alvesin 100 Amino acids solution for<br />

infusion<br />

255. Alvityl Retinolum+ Colecalciferolum+<br />

Tocopherolum+ Acidum<br />

ascorbicum+ Pyridoxinum+<br />

Thiaminum+ Nicotinamidum +<br />

Cyanocobalaminum+<br />

Riboflavinum+<br />

Dexpanthenolum+ Biotinum<br />

256. Alvogyl Eugenolum+<br />

Lidocainum<br />

257. Alyostal Prick (glycerinated<br />

solution of allergen extracts for<br />

diagnosis of allergic diseases)<br />

250ml;500ml Berlin-Chemie AG<br />

(Menarini Group)<br />

syrup 1500IU+ 150IU+ 2,5mg+<br />

37,5mg+ 0,75mg+ 2,5mg+<br />

12,5mg+ 1,5µg+ 2,5mg+<br />

21,5mg+ 25µg/5ml 150ml<br />

paste for dental<br />

use<br />

Allergen extracts for disgnosis cutaneus<br />

solution for<br />

prick-test<br />

Solvay Pharma<br />

15g+5g/100g 12g Septodont<br />

100IR/ml; 100 IC/ml;<br />

1000IC/ml<br />

Stallergenes<br />

258. Amantadin-ratiopharm Amantadini hydrochloridum film-coated tab. 100mg N20;N100 Merckle<br />

259. Amaryl Glimepiridum tab. 1mg<br />

N30; N90<br />

260. Amaryl Glimepiridum tab. 2mg<br />

N90<br />

261. Amaryl Glimepiridum tab. 3mg<br />

N90<br />

262. Amaryl 4 mg Glimepiridum tab. 4mg<br />

N30<br />

Aventis Pharma<br />

Aventis Pharma<br />

Aventis Pharma<br />

Aventis Pharma


EN<br />

128 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

263. Amaryl 6 mg Glimepiridum tab. 6mg<br />

N30<br />

264. AmBisome Amphotericinum B powder for sol.<br />

for inf.<br />

265. Ambrohexal Ambroxolum tab. 30mg<br />

N20; N50<br />

266. Ambrohexal Ambroxolum sol. 7,5mg/ml<br />

50ml; 100ml<br />

Strength Manufacturer<br />

Aventis Pharma<br />

50mg N10 NeXstar<br />

Pharmaceuticals<br />

Salutas Pharma<br />

267. Ambrohexal Syrup Ambroxolum syrup 15mg/5ml 100ml Salutas Pharma<br />

268. Ambroksolio hidrochloridas Ambroxolum syr. 100 ml —<br />

0,3 g<br />

269. Ambroksolio hidrochloridas Ambroxolum tab. 0,03 N20 Liuks<br />

270. Ambrolan<br />

30 mg<br />

Ambroxolum tab. 30mg<br />

N20; N1000<br />

271. Ambrolan retard 75 mg Ambroxolum prolongedrelease<br />

caps.<br />

272. Ambrolos Ambroxolum efferv. tab. 30mg N20 Hexal<br />

273. Ambrolos S Ambroxolum efferv. tab. 60mg N20 Hexal<br />

75mg<br />

N10<br />

Hexal<br />

Liuks<br />

Lannacher<br />

Lannacher<br />

274. Ambrosan Ambroxolum tab. 30mg N20 Pro. Med. CS Praha<br />

275. Ambrosol syrup 0,3 Ambroxolum syrup 0,3g/100ml Pliva Krakow<br />

276. Ambrosol syrup 0,6 Ambroxolum syrup 0,6g/100ml Pliva Krakow<br />

277. Amerscan DMSA Agent (Kit<br />

for the preparation of<br />

Technetium [99mTc] Succimer<br />

Injection)<br />

278. Amerscan Hepatate II Agent<br />

(Kit for the preparation of<br />

Technetium [99mTc] Colloidal<br />

Tin Injection)<br />

279. Amerscan Medronate II Agent<br />

(Kit for the preparation of<br />

Technetium [99mTc]<br />

Medronate)<br />

280. Amerscan Pentetate II Agent<br />

(Kit for the preparation of<br />

Technetium [99mTc]<br />

Pentetate)<br />

281. Amertec II Sterile Technetium-<br />

99 Generator (radionuclide<br />

generator)<br />

282. Amikacin<br />

500 mg<br />

Dimercaptosuccinic acid powder for i.v.<br />

inj.<br />

Stannous fluoride powder for i.v.<br />

inj.<br />

Methylene disphosphonic acid powder for i.v.<br />

inj.<br />

Calcium trisodium<br />

diethylenetriaminepentaacetate<br />

Sodium molybdate [99Mo]+<br />

Sodium pertechnetate [99mTc]<br />

powder for i.v.<br />

inj.<br />

radionu-clide<br />

generator<br />

1mg/vial (multidose) N2;N5 Nycomed Amersham<br />

/ MDS Nordion<br />

0,125mg/vial (multidose) N2;<br />

N5<br />

Nycomed Amersham<br />

6,25mg/vial (multidose) N2;N5 Nycomed Amersham<br />

20,6mg/vial (multidose) N2;N5 Nycomed Amersham<br />

2,5-100 GBq per generator+<br />

variable<br />

Amikacinum sol. for.inj. 250mg/ml<br />

2ml amp. N10; N100<br />

283. Amikacin 1 g Amikacinum sol.for inj. 250mg/ml<br />

4ml amp. N10; N100<br />

Nycomed Amersham<br />

Sopharma PLC<br />

Sopharma PLC<br />

284. Amikin Amikacinum sol. for inj. 500mg/2ml Bristol-Myers Squibb<br />

285. Amikin Amikacinum sol. for inj. 1 000mg/4ml Bristol-Myers Squibb


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 129<br />

No. Commercial name General name<br />

286. Amilozid-B Amiloridum+<br />

Hydrochlorothiazidum<br />

287. Aminophylli-num<br />

prolongatum<br />

Pharmaceutical<br />

form<br />

Aminophyllinum tab. 350mg<br />

N20<br />

288. Aminoplasmal Hepa-10% Isoleucine+Leucine+Lysine+<br />

Methionine+ Phenylalanine+<br />

Threonine+Tryptophan+<br />

Valine+Arginine+ Histidine+<br />

Glycine+ Alanine+ Proline+<br />

Aspartic acid+ Asparagine +<br />

Acetylcysteine +Glutamic acid+<br />

Ornithine+ Serine+ N-Acetyl-<br />

L-Tyrosine<br />

Strength Manufacturer<br />

tab. 5mg+ 50mg N20 Biogal<br />

sol. for inf. 8,8g+13,6g+ 10,6g+1,2g+<br />

1,6g+4,6g+<br />

1,5g+10,6g+<br />

8,8g+ 4,7g+ 6,3g+8,3g+<br />

7,1g+2,5g+ 0,55g+0,8g+<br />

5,7g+1,66g+ 3,7g+0,86g/<br />

1000ml<br />

289. Aminoplasmal-10% Amino acids sol. for inf. 100g/l; Osmolarity<br />

885 mOsm/l 500ml N10;<br />

1000ml N6<br />

290. Aminoplasmal-10% E Amino acids sol. for inf. 100g/l; Osmolarity<br />

1030mOsm/l 500ml N10;<br />

1000ml N6<br />

291. Aminoplasmal-5% E Amino acids sol. for inf. 50g/l; Osmolarity 595 mOsm/l<br />

500ml N10<br />

292. Aminoven 10% Isoleucinum+ Leucinum+<br />

Lysini acetas +Methioninum+<br />

Phenylalaninum+<br />

Threoninum+ Tryptophanum+Valinum+<br />

Argininum+Histidinum+<br />

Alaninum+Glycinum+<br />

Prolinum+Serinum+<br />

Tyrosinum+ Taurinum<br />

293. Aminoven 15% Isoleucinum+Leucinum+Lysini<br />

acetas +Methioninum+<br />

Phenylalaninum+Threoninum+<br />

Tryptophanum+ Valinum+<br />

Argininum+Histidinum+<br />

Alaninum+ Glycinum +<br />

Prolinum + Serinum+<br />

Tyrosinum +Taurinum<br />

294. Aminoven 5% Isoleucinum+Leucinum +<br />

Lysini acetas +Methioninum+<br />

Phenylalaninum+Threoninum+<br />

Tryptophanum+ Valinum+<br />

Argininum+ Histidinum+<br />

Alaninum+ Glycinum+<br />

Prolinum+ Serinum+<br />

Tyrosinum+ Taurinum<br />

295. Amiodaron Balkanpharma<br />

200 mg<br />

296. Amiodarone Alpharma Tablets<br />

200mg<br />

sol. for inf. 5g+7,4g+ 9,31g+4,3g+5,1g+<br />

4,4g+ 2g+6,2g+12g+3g+14g+<br />

11g+11,2g+ 6,5g+0,4g+ 1g<br />

/1000ml 500ml; 1000ml<br />

sol. for inf. 5,2g+8,9g+15,66g+3,8g+<br />

5,5g+8,6g+1,6g+5,5g+20g+<br />

7,3g+25g+18,5g+17g+9,6g+<br />

0,4g+2g/1000ml 250ml;<br />

500ml1000ml<br />

sol. for inf. 2,5g+3,7g+ 4,655g+ 2,15g+<br />

2,55g+2,2g+1g+ 3,1g+6g+<br />

1,5g+7g+ 5,5g+5,6g+ 3,25g+<br />

0,2g+0,5g/1000ml 500ml;<br />

1000ml<br />

Amiodaronum tab. 200mg<br />

N30<br />

Pliva Krakow<br />

Braun Melsungen<br />

Braun Melsungen<br />

Braun Melsungen<br />

Braun Melsungen<br />

Fresenius Kabi<br />

Fresenius Kabi<br />

Fresenius Kabi<br />

Balkanpharma-<br />

Troyan<br />

Amiodaronum tablets 200mg N30 Alpharma Limited<br />

297. Amiokordin Amiodaronum tab. 200mg<br />

N30; N60<br />

298. Amiokordin Amiodaronum solution for<br />

injection<br />

KRKA<br />

150mg/3ml N5 KRKA<br />

299. Amitriptilinas 25 mg Amitriptylinum tab. 25 mg N50, N60 Liuks


EN<br />

130 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

300. Amitriptilinas 25mg Amitriptylinum tab. 25mg<br />

N50<br />

Strength Manufacturer<br />

Endokrininiai<br />

preparatai<br />

301. Amitriptilins-Grindeks Amitriptylinum tab. 25mg N50 Grindeks<br />

302. Amitriptilins-Grindeks Amitriptylinum tab. 10mg N50 Grindeks<br />

303. Amitriptylin Lečiva Amitriptylinum sol. for inj. 20mg/2ml N10 (10×2ml) Lečiva<br />

304. Amitriptylin-Slovakofarma Amitriptylinum coated tab. 25mg N20; N50; N100 Slovakofarma<br />

305. Amitriptylinum Amitriptylinum drag. 25mg<br />

N60<br />

306. Amitriptylinum Amitriptylinum drag. 10mg<br />

N60<br />

ICN Polfa Rzeszow<br />

ICN Polfa Rzeszow<br />

307. Amocileks Amoxicillinum caps. 500mg N10 Merck Generics/<br />

Grindex<br />

308. Amocileks Amoxicillinum caps. 250mg N20 Merck Generics/<br />

Grindeks<br />

309. Amoksicilinas Amoxicillinum tab. 250mg<br />

N10; N16; N20;N24<br />

310. Amoksicilinas<br />

(Caps.Amoxicillin)<br />

Liuks<br />

Amoxicillinum caps. 250mg N10; N20 Sanitas<br />

311. Amoksicilino mikstūra Amoxicillinum mixture 125mg/5ml 100ml Athlone Laboratories<br />

312. Amoksicilino mikstūra Amoxicillinum mixture 250mg/5ml 100ml Athlone Laboratories<br />

313. Amoksiklav Amoxicillinum+ Acidum<br />

clavulanicum<br />

314. Amoksiklav Amoxicillinum+ Acidum<br />

clavulanicum<br />

315. Amoksiklav 2x Amoxicillinum+ Acidum<br />

clavulanicum<br />

316. Amoksiklav 2x Amoxicillinum+ Acidum<br />

clavulanicum<br />

317. Amoksiklav 2x suspension Amoxicillinum+ Acidum<br />

clavulanicum<br />

318. Amol Heilkräutergeist N<br />

liquidum<br />

Ol.Menthae pip.+Ol.Melissae<br />

ind.+Ol.Caryophylli+<br />

Ol.Cinnamomi+<br />

Ol.Lavandulae+ Ol. Citri+<br />

Mentholum+ Spiritus<br />

aethylicus 96%<br />

powder for<br />

sol.for inj.<br />

powder for<br />

sol.for inj.<br />

film-coated tab. 500mg+<br />

125mg<br />

N10; N14<br />

film-coated tab. 875mg+<br />

125mg<br />

N10; N14<br />

powder for oral<br />

susp.<br />

500mg+ 100mg/vial N5 Lek<br />

1g+ 200mg/vial N5 Lek<br />

400mg+<br />

57mg/5ml<br />

35ml; 50ml; 70ml; 140ml<br />

mixt. 2,4g+1g+1g+2,4g+2,4g+<br />

5,7g+17,23g+637,83g/ 1000g<br />

Lek<br />

Lek<br />

Lek<br />

Roland Arzneimittel<br />

319. Amoniako 10% tirpalas Sol. Ammonii caustici 25% sol. 40ml/100ml 40ml Vilniaus f.f.<br />

320. Amopen<br />

250 mg<br />

321. Amopen<br />

500 mg<br />

Amoxicillinum caps., hard 250mg N20 Balkanpharma-<br />

Razgrad<br />

Amoxicillinum caps., hard 500mg N20 Balkanpharma-<br />

Razgrad<br />

322. Amopen 125 Amoxicillinum gran. for oral<br />

susp.<br />

323. Amopen 250 Amoxicillinum gran. for oral<br />

susp.<br />

125mg/5ml 1,5g(60ml) Balkanpharma-<br />

Razgrad<br />

250mg/5ml 3g(60ml) Balkanpharma-<br />

Razgrad


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 131<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

324. Amoxicillin Amoxicillinum caps. 250mgN15 Pliva Krakow<br />

325. Amoxicillin 1000 Stada Amoxicillinum film-coated tab. 1000mg N10;N20 Stada<br />

326. Amoxicillin 250 Stada Amoxicillinum powder for oral<br />

susp.<br />

327. Amoxicillin-ratiopharm<br />

250 TS<br />

Amoxicillinum gran.for oral<br />

susp.<br />

328. Amoxycillin Amoxicillinum powder for oral<br />

susp.<br />

250mg/5ml 80ml Stada<br />

250mg/5ml 50g (100ml) Merckle<br />

250mg/5ml 60ml Teva<br />

329. Amoxycillin Amoxicillinum caps. 500mg N20 Teva<br />

330. Amoxycillin Amoxicillinum powder for oral<br />

susp.<br />

331. Ampicilino 250 mg tablete˙s Ampicillinum tab. 250mg<br />

N24<br />

332. Ampicilino 250mg tablete˙s Ampicillinum tab. 250mg<br />

N10; N24<br />

333. Ampicillin Ampicillinum inj. 1g/vial<br />

N20<br />

334. Ampicillin Ampicillinum tab. 0,5g<br />

N16<br />

335. Ampicillin Ampicillinum inj. 0,25g/vial<br />

N20<br />

336. Ampicillin Ampicillinum inj. 0,5g/vial<br />

N20<br />

337. Ampicillin 1g Ampicillinum powder for sol.<br />

for inj.<br />

125mg/5ml 60ml Teva<br />

Sanitas<br />

Liuks<br />

Polfa Tarchomin<br />

Polfa Tarchomin<br />

Polfa Tarchomin<br />

Polfa Tarchomin<br />

1g/vial N10 Balkanpharma-<br />

Razgrad<br />

338. Ampicillin 500 mg Ampicillinum caps., hard 500mg N20 Balkanpharma-<br />

Razgrad<br />

339. Ampisulcillin Ampicillinum+ Sulbactamum powder for<br />

sol.for inj.<br />

340. Ampisulcillin Ampicillinum+ Sulbactamum powder for<br />

sol.for inj.<br />

341. Ampisulcillin Ampicillinum+ Sulbactamum powder for<br />

sol.for inj.<br />

342. Amukine 0,06% Chlorine (active) sol.for local<br />

application<br />

1g+ 500mg/vial N10 Balkanpharma-<br />

Razgrad<br />

2g+1g vials N10 Balkanpharma-<br />

Razgrad<br />

500mg+ 250mg/vial N10 Balkanpharma-<br />

Razgrad<br />

60mg/100ml 125ml; 250ml;<br />

500ml; 1000ml<br />

343. A-Mulsin forte Retinolum oral emuls. 16,5mg (30000IE)/g 50g Mucos Pharma<br />

344. Anacidol suspension Calcii carbonas +Aluminii<br />

hydroxidum/Magnesii carbonas<br />

345. Anaesthetic Ether Diethyl ether inhalation<br />

vapour, liquid<br />

Gifrer<br />

oral susp. 250mg+ 700mg/5ml 200ml Spirig<br />

100ml; 500ml Den norske<br />

Eterfabrikk<br />

346. Anafranil Clomipraminum sol. for inj. 25mg/2ml amp. N10 Nycomed Austria<br />

347. Anafranil<br />

25 mg<br />

Clomipramini hydrochloridum coated tablet 25mg N30 Novartis Pharma


EN<br />

132 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

348. Analgin Metamizolum natricum tab. 500mg<br />

N10<br />

349. Analgin Metamizolum natricum tab. 500mg<br />

N20; N500<br />

350. Analginas 500mg Metamizolum natricum tab. 500mg<br />

N10<br />

351. Analgino<br />

50 % tirpalas injekcijoms<br />

Metamizolum natricum sol. for inj. 500mg/ml 1ml, 2ml, 5ml<br />

amp. N5; N10<br />

352. Analgino 500mg tablete˙s Metamizolum natricum tab. 500mg<br />

N50; N100<br />

Strength Manufacturer<br />

Medica<br />

Sopharma PLC<br />

Liuks<br />

Sanitas<br />

Sanitas<br />

353. Androcur Cyproteroni acetas tab. 50mg N20;N50 Schering<br />

354. Androcur Depot Cyproteroni acetas sol. for inj. 300mg/3ml amp. N3 Schering<br />

355. Andropatch Testosteronum transdermal<br />

patch<br />

356. Angi Sept Mentholum+ Anetholum+<br />

Menthae pip. aetheroleum+<br />

Alcohol 2,4-dichlorbenzylicus<br />

357. Angin-Heel S Mercurius cyanatus D8 +<br />

Phytolacca americana D4 +<br />

Apis mellifica D4+Arnica<br />

montana D4+Hepar sulfuris<br />

D6 + Solanum dul-camara D4<br />

+Atropa belladonna D4<br />

358. Aniron Interferonum alfa-2a<br />

humanum recombinatum<br />

359. Aniron Interferonum alfa-2a<br />

humanum recombinatum<br />

360. Aniron Interferonum alfa-2a<br />

humanum recombinatum<br />

361. Aniron Interferonum alfa-2a<br />

humanum recombinatum<br />

lozenges 5,4mg+ 2,5mg+<br />

1mg+<br />

2,5mg<br />

N12<br />

12,2mg (2,5mg/24h) N60 SmithKline Beecham<br />

tab. 30mg+30mg+30mg+ 30mg+<br />

60mg+60mg+ 60mg<br />

N50<br />

sol.for inj.prefilled<br />

syringes<br />

sol.for inj.prefilled<br />

syringes<br />

sol.for inj.prefilled<br />

syringes<br />

sol.for inj.prefilled<br />

syringes<br />

Naturwaren<br />

Heel<br />

3 MIU Sicor Biotech<br />

6 MIU Sicor Biotech<br />

9 MIU Sicor Biotech<br />

18 MIU Sicor Biotech<br />

362. Ankštpipiriu˛ tinktūra Fructus Capsici tinct. 100 g Ethanolum ad 1l<br />

50 ml, 100 ml<br />

363. Anopyrin Acidum acetylsalicylicum tab. 100mg<br />

N20; N50<br />

364. Anopyrin Acidum acetylsalicylicum tab. 30mg N20;<br />

N50<br />

365. Antelepsin 1 Clonazepamum tab. 1mg N50 AWD<br />

366. Anteovin Ethinylestradiolum+<br />

Levonorgestrelum<br />

tab.(11<br />

white+10<br />

coloured)<br />

367. Anticol Disulfiramum tab. 500mg<br />

N30<br />

white: 0,05mg+0,05mg;<br />

coloured: 0,05mg+0,125mg<br />

N3×21<br />

368. Antidiab Glipizidum tab. 5mg N30 KRKA<br />

369. AntiFlu Paracetamolum+<br />

Chlorphenaminum+<br />

Pseudoephedrinum<br />

powder for<br />

dissolution in<br />

water<br />

Bakteriniai<br />

preparatai<br />

Slovakofarma<br />

Slovakofarma<br />

Gedeon Richter<br />

Polfa Warsaw<br />

650mg+4mg+60mg/dose N6 Perrigo


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 133<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

370. Anti-Kalium Calcii polystyreni sulphonas gran. in sachets 880mg/1g 15g/sachet N20;<br />

N50<br />

371. Antiseptine (Antiseptinas) Ol.Thymi rectif.+ Extr.flor.<br />

Echinaceae sicc. +Propolum+<br />

Ac.ascorbicum<br />

Strength Manufacturer<br />

caps. 20mg+ 20mg+ 100mg+ 60mg<br />

N40<br />

372. Antrex Calcii folinas tab. 15mg N100 Orion<br />

373. Antrex Calcii folinas inj. 3mg/ml 2ml N5; 5ml N5 Orion<br />

374. Anusolum Suppositoria Xeroformum+<br />

Extr.Belladonnae+ Zinci sulfas<br />

Medice<br />

Arco-Chemie<br />

supp. 100mg+ 20mg+ 50mg N10 Nizˇfarm<br />

375. APAP Caplets Paracetamolum caplets 500mg N2; N12; N50 Unilab<br />

376. Apaurin Diazepamum film-coated tab. 2mg<br />

N30<br />

377. Apaurin Diazepamum film-coated tab. 5mg<br />

N30<br />

378. Apaurin Diazepamum sol. for inj. 10mg/2 ml amp. N10 KRKA<br />

379. Apetita˛ zˇadinantis vaistazˇoliu˛<br />

mišinys<br />

Herb. Arthemisiae absinthii+<br />

Herb. Millefolii<br />

380. Apilepsin Natrii valproas gastro-resistant<br />

tab.<br />

381. Apilepsin Natrii valproas gastro-resistant<br />

tab.<br />

382. Apisarthron Apitoxinum+ Methylis<br />

salicylas+ Allylisothiocyonatum<br />

383. Apis-Homaccord Apis mellifica D2+Apis<br />

mellifica D10+Apis mellifica<br />

D30+ Apis mellifica D200+<br />

Apis mellifica D1000+<br />

Apisinum D6+ Apisinum<br />

D30+ Scilla D2+Scilla D10 +<br />

Scilla D30+ Kalium<br />

stibyltataricum D2+ Kalium<br />

stibyltataricum D10+ Kalium<br />

stibyltatar. D30+Kalium<br />

stibyltatar D200<br />

herbal tea 80g+20g 100g;50g;50g<br />

(2g×25)<br />

150mg<br />

N100<br />

300mg<br />

N100<br />

ointment 3mg+10g+ 1g/100g 20g; 30g;<br />

50g; 100g<br />

drops 0,1g+0,1g+ 0,1g+0,1g+ 0,1g+<br />

0,25g+0,25g+ 0,25g+ 0,25g+<br />

0,25g+0,4g+0,4g+0,4g+<br />

0,4g/100g Ethanolum 35%<br />

(V/V) 30ml; 100ml<br />

KRKA<br />

KRKA<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

KRKA<br />

KRKA<br />

esparma<br />

384. Apo-Acyclovir Aciclovirum tab. 200mg N100 Apotex<br />

385. Apo-Amitriptyline Amitriptylinum coated tab. 25mg N50;N60 Apotex/Norfachema<br />

386. Apo-Amitriptyline 10mg Amitriptylinum coated tab. 10mg<br />

N60<br />

387. Apo-Doxy 100mg Doxycyclinum caps., hard 100mg<br />

N10<br />

388. Apo-Fluoxetine<br />

10 mg<br />

389. Apo-Fluoxetine<br />

20 mg<br />

Fluoxetinum caps., hard 10mg<br />

N7;N10;N14;N20;N28; N30<br />

Fluoxetinum caps., hard 20mg N7;N10;N14;N20;N28;<br />

N30<br />

Heel<br />

Apotex/Norfachema<br />

Apotex/Norfachema<br />

Apotex/Norfachema<br />

Apotex/Norfachema<br />

390. Apo-Fluvoxamine 100 mg Fluvoxaminum film-coated tab. 100mg N20;N30 Apotex/Norfachema<br />

391. Apo-Fluvoxamine 50 mg Fluvoxaminum film-coated tab. 50mg N20;N30;N50 Apotex/Norfachema<br />

392. Apo-Furosemide Furosemidum tab. 40mg N100 Apotex


EN<br />

134 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

393. Apo-Furosemide Furosemidum tab. 80mg N100 Apotex<br />

394. Apo-Furosemide Furosemidum tab. 20mg N100 Apotex<br />

395. Apo-K<br />

600 mg<br />

Kalii chloridum slow-release<br />

tab.<br />

396. Apo-Selegiline Selegilinum tab. 5mg<br />

N100<br />

600mg N30;N60; N100 Apotex/Norf-achema<br />

Apotex<br />

397. Apo-Trifluopera-zine Trifluoperazinum film-coated tab. 20mg Apotex<br />

398. Apovit Sana-Sol Retinolum+Colecalciferolum +<br />

Tocophe rolum +Thiaminum+<br />

Riboflavinum+<br />

Nicotinamidum+<br />

Pyridoxinum+Panthenolum+<br />

Cyanocobalaminum+Acidum<br />

ascorbicum<br />

syrup, nonsugar<br />

1000IU+400IU+10mg+<br />

1,1mg+1,2mg+1,6mg+<br />

1,2mg+4mg+2,5µg+ 60mg/<br />

10ml 250ml; 500ml<br />

Elverum Plant<br />

399. Aprovel Irbesartanum tab. 300mg N14; N28; N56; N98 Sanofi Winthrop<br />

400. Aprovel Irbesartanum tab. 150mg N14; N28; N56; N98 Sanofi Winthrop<br />

401. Aprovel Irbesartanum tab. 75mg N14; N28; N56; N98 Sanofi Winthrop<br />

402. Apulein Budesonidum cream 3,75mg/15g Gedeon Richter<br />

403. Apulein Budesonidum ointment 3,75mg/15g Gedeon Richter<br />

404. Apydan<br />

300 mg<br />

405. Apydan<br />

600 mg<br />

Oxcarbazepinum tab. 300mg N50;N100;N200 Desitin<br />

Oxcarbazepinum tab. 600mg N50;N100;N200 Desitin<br />

406. Apyniu˛ spurgai (smulkinti) Strob.Humuli lupuli herbal tea 100g;50g Švenčioniu˛<br />

vaistazˇole˙s<br />

407. Aqua ad iniectabilia in<br />

ampulis/Injek-cinis vanduo<br />

ampule˙se<br />

Aqua pro injectionibus solvent 5ml; 10ml amp. Sanitas<br />

408. Aquadetrim Vitaminas D3 Colecalciferolum oral sol. 15 000 UI/ml 10ml Medana Pharma<br />

Terpol<br />

409. Arava 10 mg Leflunomidum film-coated tab. 10mg N30 Usiphar<br />

410. Arava 100mg Leflunomidum film-coated tab. 100mg N3 Usiphar<br />

411. Arava 20 mg Leflunomidum film-coated tab. 20mg N30 Usiphar<br />

412. Arcalen Arnicae herba<br />

cum flos et Calendulae flos<br />

extr.spiss.+<br />

Aesculinum+Calami<br />

aetheroleum<br />

ointment 2g+1g+400mg/100g<br />

30g<br />

Herbapol<br />

413. Arcoxia Etoricoxib tablets 60mg N7;N14;N28 Merck Sharp &<br />

Dohme B.V.<br />

414. Arcoxia Etoricoxib tablets 90mg N7;N14;N28 Merck Sharp &<br />

Dohme B.V.<br />

415. Arcoxia Etoricoxib tablets 120mg N7;N14;N28 Merck Sharp &<br />

Dohme B.V.<br />

416. Ardeyhepan N Extr. fruct. Cardui Mariae<br />

siccum (20-33:1)<br />

drag. 162,5-250mg N20;N60; N100 Ardeypharm


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 135<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

417. Arduan Pipecuronii bromidum powder and<br />

solvent for sol.<br />

for inj.<br />

418. Aredia Dinatrii pamidronas (Acidum<br />

pamidronicum)<br />

powder and<br />

solvent for sol<br />

for inj.<br />

Strength Manufacturer<br />

4mg/vial (solvent: Sodium<br />

chloride 0,9 % 2ml) N25<br />

Gedeon Richter<br />

15mg/vial N4 Nycomed Austria<br />

419. Argosulfan Argentum sulfathiazolum cream 20mg/g 40g;400g Jelfa<br />

420. Aricept Donepezilum coated tab. 10mg<br />

N28<br />

421. Aricept Donepezilum coated tab. 5mg<br />

N28; N98<br />

422. Arilin 250 Metronidazolum film-coated tab. 250mg Wolff<br />

423. Arilin 500 Metronidazolum coated tab. 500mg N10;N20 Dr. August Wolff<br />

GmbH & Co<br />

Arzneimittel<br />

424. Arilin Kombi Metronidazolum vaginal use/oral<br />

use<br />

100mg/pessary; 250mg/tablet<br />

N12 / N6<br />

425. Arilin rapid Metronidazolum pessary 1000mg N2 Wolff<br />

426. Arilin Vaginalzäpfchen Metronidazolum pessary 100mg N6 Wolff<br />

Pfizer<br />

Pfizer<br />

Dr. August Wolff<br />

GmbH & Co<br />

Arzneimittel<br />

427. Arimidex Anastrozolum tab. 1mg N28 AstraZeneca<br />

428. Aritmilis Amiodoronum tab. 0,2 g N20 Liuks<br />

429. Arnica-Heel Arnica montana D3 +Bryonia<br />

cretica D4 + Acidum<br />

benzoicum e resina D3+<br />

Colchicum autumnale D4+<br />

Mercurialis perennis D3+<br />

Eupatorium cannabinum D4+<br />

Solanum lycopersicum D3+<br />

Echinacea angustifolia D3+<br />

Rhus toxicoden-dron D6+<br />

Eucalyptus globulus D4+<br />

Baptisia tinctoria D4<br />

drops 5g+5g+5g+ 5g+5g+5g+ 5g+<br />

5g+10g+10g+10g+ 10g+10g+<br />

10g 30ml;100ml<br />

430. Arnikos tinktūra Arnicae flores tinct. 100g (Ethanolum 70% ad 1l)<br />

40ml<br />

431. Arnikos tinktūra Flos Arnicae tinct. 100 g Ethanolum ad 1l<br />

50 ml; 100ml<br />

Heel<br />

Vilniaus f.f.<br />

Bakteriniai<br />

preparatai<br />

432. Aromasin Exemestanum coated tab. 25mg N30 Pharmacia & Upjohn<br />

433. Aromatinis vaistazˇoliu˛ mišinys Fruct.Rosae+Fruct.Carvi+<br />

Herb.Hyperici +Herb.Serpylli+<br />

Fol. Menthae piperitae<br />

434. Aromatol Ol.Melissae+ Ol.Caryophylli+<br />

Ol.Cinnamomi+ Ol.Citri+<br />

Ol.Menthae pip.+<br />

Ol.Levandulae+ Mentholum+<br />

Ethanolum 70%<br />

435. Arpha Capsules Paracetamolum+<br />

Chlorphenaminum<br />

herbal tea 27,8g+5,55g+5,55g+3,7g+<br />

7,4g/50g<br />

100g; 50g; 30g (1,5g×20)<br />

liq. 1g+1g+ 2,4g+5,7g+ 2,4g+<br />

2,4g+ 17,23g+ad 1000g<br />

100ml; 250ml<br />

caps. 500mg+4mg N16 Urgo<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Hasco-Lek<br />

436. Artamin Penicillaminum caps. 250mg N50 Biochemie<br />

437. Artamin Penicillaminum caps. 150mg N50 Biochemie


EN<br />

136 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

438. Artelac Hypromellosum eye drops 3,2mg/ml 10ml Mann<br />

439. Arterico AC Ginkgo Biloba dry extr. +<br />

Crataegus dry extr. + Passion<br />

flower dry extr.<br />

440. Arthritis formula Bengay<br />

neriebus skausma˛ malšinantis<br />

kremas<br />

caps. 40 mg+ 80 mg + 20 mg<br />

N20; N30; N60<br />

Methylis salicylas+ Mentholum cream 30%+8%<br />

57g<br />

441. Arthrotec Diclofenacum+ Misoprostolum tab. 50mg+0,2mg N20; N100 Searle<br />

442. Arthryl Glucosamine sulfate<br />

(Crystalline)<br />

powder for oral<br />

solution<br />

Hasco-Lek/ Acorus<br />

calamus<br />

Pfizer<br />

1,5g/sachet Rottapharm<br />

443. Artišoku˛ ekstraktas Cynarae folium extr. 1000 g Ethanolum ad 1 l<br />

25 ml; 50 ml;<br />

100 ml<br />

444. Arutimol<br />

0,25 %<br />

Timololum eye drops, sol. 2,5mg/ml<br />

5ml<br />

445. Arutimol 0,5% Timololum eye drops, sol. 5mg/ml<br />

5ml<br />

446. Asasantin Retard Dipyridamolum+ Acidum<br />

salicylicum<br />

447. Ascaff Acidum acetylsalicylicum+<br />

Coffeinum<br />

448. Ascofen-P Acidum acetylsalicylicum+<br />

Paracetamolum+ Coffeinum<br />

Bakteriniai<br />

preparatai<br />

Chauvin/<br />

Chauvin ankerpharm<br />

Chauvin/<br />

Chauvin ankerpharm<br />

caps. 200mg+25mg N30;N60 Boehringer<br />

Ingelheim<br />

tab. 400mg+ 32mg N50 Perrigo<br />

tab. 200mg+ 200mg+ 40mg N10 Leksredstva<br />

449. Ascofer Ferrosi gluconas (Ferrum) drag. 200mg (23,2mg) N50 Espefa<br />

450. Asentra Sertralinum film-coated tab. 50mg N28 KRKA<br />

451. Asentra Sertralinum film-coated tab. 100mg N28 KRKA<br />

452. Askofenas L Acidum acetylsalicylicum+<br />

Paracetamolum+ Coffeinum<br />

453. Askorbo rūgšties<br />

100 mg tablete˙s su cukrumi<br />

454. Askorbo rūgšties<br />

200 mg tablete˙s su cukrumi<br />

455. Askorbo rūgšties<br />

25 mg tablete˙s<br />

456. Askorbo rūgšties<br />

500 mg tablete˙s<br />

457. Askorbo rūgšties<br />

500 mg tablete˙s<br />

458. Askorbo rūgšties<br />

500 mg tablete˙s MDF<br />

459. Askorbo rūgšties 500 mg<br />

tablete˙s<br />

460. Askorbo rūgšties (Vitamino C)<br />

5 % tirpalas injekcijoms<br />

461. Askorbo rūgšties (Vitamino C)<br />

5 % tirpalas injekcijoms<br />

tab. 200mg+ 200mg+ 40mg N10 Liuks<br />

Acidum ascorbicum tab. 100mg<br />

N20; N50; N100<br />

Acidum ascorbicum tab. 200mg<br />

N20; N50; N100<br />

Acidum ascorbicum tab. 25mg<br />

N10<br />

Bakteriniai<br />

preparatai<br />

Bakteriniai<br />

preparatai<br />

Liuks<br />

Acidum ascorbicum tab. 500mg N50 Sanitas<br />

Acidum ascorbicum tab. 500mg<br />

N20; N50<br />

Acidum ascorbicum tab. 500mg<br />

N20; N50<br />

Medicata filia<br />

Medicata filia<br />

Acidum ascorbicum tab. 500mg N20; N30; N50 KMU vaistine˙<br />

Acidum ascorbicum sol. for inj. 50mg/ml<br />

2ml N10;<br />

5ml N5<br />

Acidum ascorbicum sol. for inj. 50mg/ml 2ml amp.<br />

N10<br />

Sanitas<br />

Endokrininiai<br />

preparatai


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 137<br />

No. Commercial name General name<br />

462. Askorbo rūgšties 25mg<br />

tablete˙s<br />

Pharmaceutical<br />

form<br />

Acidum ascorbicum tab. 25mg<br />

N10<br />

Strength Manufacturer<br />

Medicata filia<br />

463. Askorbo rūgštis Acidum ascorbicum tab. 500mg N20; N30 Endokrininiai<br />

preparatai<br />

464. Askorbo rūgštis Acidum ascorbicum+<br />

Glucosum<br />

465. Askorbo rūgštis<br />

500 mg<br />

466. Askorbo rūgštis<br />

100 mg su fruktoze MDF<br />

467. Askorbo rūgštis<br />

200 mg su fruktoze MDF<br />

Acidum ascorbicum tab. 500mg<br />

N50<br />

tab. 100mg+ 877mg N10 Liuks<br />

Liuks<br />

Acidum ascorbicum tab. 100mg N50 Medicata filia<br />

Acidum ascorbicum tab. 200mg N20 Medicata filia<br />

468. Askorbo rūgštis MDF Acidum ascorbicum powder 15g Medicata filia<br />

469. Askorbo rūgštis MDF Acidum ascorbicum powder 1000mg N20 Medicata filia<br />

470. Askorutinas Acidum ascorbicum+<br />

Rutosidum<br />

471. Askorutinas Acidum ascorbicum+<br />

Rutosidum<br />

472. Askorutinas MDF Acidum ascorbicum+<br />

Rutosidum<br />

473. Askorutino tablete˙s Acidum ascorbicum+<br />

Rutosidum<br />

474. Asparaginase 10000 medac L-asparaginase powder for<br />

solution for<br />

injection or<br />

inffusion<br />

475. Asparaginase 5000 medac L-asparaginase powder for<br />

solution for<br />

injection or<br />

infusion<br />

476. Asparkamas Magnesii aspartas+Kalii<br />

aspartas<br />

477. Asparkamo tablete˙s Magnesii aspartas+Kalii<br />

aspartas<br />

tab. 50mg+50mg N10;N20; N50 KMA vaistine˙<br />

tab. 50mg+50mg N10; N30; N50 Liuks<br />

tab. 50mg + 50mg; N30; N50 Medicata filia<br />

tab. 50mg+50mg N10;N20; N50 Bakteriniai<br />

preparatai<br />

tab. 175mg+ 175mg<br />

N10<br />

10000 I.U./vial N5 medac GmbH<br />

5000 I.U./vial N5 medac GmbH<br />

tab. 175mg+175mg N20; N50;<br />

N100<br />

478. Aspartamo tablete˙s Aspartamum tab. N100 Liuks<br />

479. Aspegic<br />

1 000 mg<br />

480. Aspegic<br />

500 mg<br />

481. Aspegic Children<br />

250 mg<br />

Lysini acetylsalicylas (Acidum<br />

acetylsalicylicum)<br />

Lysini acetylsalicylas (Acidum<br />

acetylsalicylicum)<br />

Lysini acetylsalicylas (Acidum<br />

acetylsalicylicum)<br />

482. Aspegic for infants Lysini acetylsalicylas (Acidum<br />

acetylsalicylicum)<br />

483. Aspegic injectable<br />

0,5 g<br />

Lysini acetylsalicylas (Acidum<br />

acetylsalicylicum)<br />

powder for oral<br />

sol.<br />

powder for oral<br />

sol.<br />

powder for oral<br />

sol.<br />

powder for oral<br />

sol.<br />

powder for sol.<br />

for inj.<br />

1 800mg<br />

(1 000mg)/ 2 046mg<br />

single-dose sachets N20<br />

900mg (500mg)/<br />

1 023mg single-dose sachets<br />

N20<br />

450mg (250mg)/ 511,5mg<br />

single-dose sachets N20<br />

180mg (100mg)/ 204,6mg<br />

single-dose sachets N20<br />

Liuks<br />

Sanitas<br />

Synthelabo<br />

Synthelabo<br />

Synthelabo<br />

Synthelabo<br />

900mg (500mg)/ 5ml vial N20 Synthelabo


EN<br />

138 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

484. Aspegic injectable<br />

0,5 g<br />

Lysini acetylsalicylas (Acidum<br />

acetylsalicylicum)<br />

485. Aspegic injectable 1 g Lysini acetylsalicylas (Acidum<br />

acetylsalicylicum)<br />

Pharmaceutical<br />

form<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

486. Aspirin 100mg Acidum acetylsalicyliccum tab. 100mg<br />

N100<br />

Strength Manufacturer<br />

900mg (500mg)/ vial+5ml<br />

water for inj. amp. N6<br />

1 800mg (1 000mg)/ vial +<br />

5ml water for inj. amp. N6<br />

487. Aspirin 500mg Acidum acetylsalicylicum tab. 500mg N20;N50;<br />

N100<br />

488. Aspirin-C Acidum acetylsalicylicum+<br />

Acidum ascorbicum<br />

489. Asprovit+C Acidum acetylsalicylicum+<br />

Acidum ascorbicum<br />

Synthelabo<br />

Synthelabo<br />

Bayer Pharma<br />

Bayer Pharma<br />

efferv. tab. 400mg+240mg N10 Bayer Bitterfeld/<br />

Bayer Pharma<br />

effervescent<br />

tablet<br />

490. ASS 500 Stada Acidum acetylsalicylicum tab. 500mg<br />

N10; N30; N100<br />

491. ASS+C-ratiopharm Acidum acetylsalicylicum+<br />

Acidum ascorbicum<br />

400mg+ 300mg N10;N20 OU Vitale-XD<br />

Stada<br />

efferv. tab. 600mg+ 200mg N10;N20 Merckle<br />

492. Astmopent Orciprenalinum sol. for inj. 0,5mg/ml<br />

1ml amp.N10<br />

493. Astmopent Orciprenalinum tab. 20mg<br />

N20<br />

494. Asvitol Acidum ascorbicum tab. 25mg<br />

N10<br />

495. Atacand Candesartanum cilexetilum tab. 4mg<br />

N100<br />

496. Atacand Candesartanum cilexetilum tab. 8mg<br />

N100<br />

497. Atacand Candesartanum cilexetilum tab. 16mg<br />

N100<br />

498. Atarax Hydroxyzinum sol. for inj. 10mg/2ml<br />

N6<br />

499. Atarax Hydroxyzinum film-coated tab. 25mg<br />

N25; N100<br />

Polfa Warsaw<br />

Polfa Warsaw<br />

Marbiofarm<br />

Astra<br />

AstraZeneca<br />

AstraZeneca<br />

UCB Pharma Oy<br />

UCB Pharma Oy<br />

500. Atarax Hydroxyzinum syrup 10mg/5ml 200ml UCB Pharma<br />

501. Atcardil 100 Atenololum tab. 100mg N70 Sun<br />

502. Atcardil 50 Atenololum tab. 50mg N70 Sun<br />

503. Atenodeks Atenololum tab. 25mg N20 Grindeks<br />

504. Atenolol Atenololum film-coated<br />

tablets<br />

505. Atenolol Atenololum film-coated<br />

tablets<br />

506. Atenolol 100 Stada Atenololum tab. 100mg<br />

N50; N100<br />

507. Atenolol 25 Stada Atenololum tab. 25mg<br />

N20; N50; N100<br />

25mg N30 Balkanpharma-<br />

Dupnitza AD<br />

50mg N30 Balkanpharma-<br />

Dupnitza AD<br />

Stada<br />

Stada


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 139<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

508. Atenolol 50 Stada Atenololum tab. 50mg<br />

N20; N50; N100<br />

509. Atenolol Alpharma Tablets<br />

50 mg<br />

Atenololum tab. 50mg<br />

N30<br />

Strength Manufacturer<br />

510. Atenolol tablets 100mg Atenololum tab. 100mg N10 Pliva<br />

511. Atenolol tablets 50 mg Atenololum tab. 50mg N30 Pliva<br />

512. Atenololio<br />

50 mg tablete˙s<br />

Atenololum tab. 50mg<br />

N30<br />

Stada<br />

Alpharma<br />

Endokrininiai<br />

preparatai<br />

513. Atenolol-ratiopharm 100 Atenololum film-coated tab. 100mg N30 Merckle<br />

514. Atenolol-ratiopharm 25 Atenololum film-coated tab. 25mg N30 Merckle<br />

515. Atenolol-ratiopharm 50 Atenololum film-coated tab. 50mg N30 Merckle<br />

516. Atenololum 100 Atenololum tab. 100 mg N10; N30 Liuks<br />

517. Atenololum 50 Atenololum tab. 50 mg N10; N30 Liuks<br />

518. ATG — Fresenius Rabbit immunoglobulin concentrate for<br />

inf.<br />

519. Atoris Atorvastatinum film-coated<br />

tablets<br />

520. Atoris Atorvastatinum film-coated<br />

tablets<br />

521. Atrican 250 Tenonitrozolum gastro-resistant<br />

caps., soft<br />

20mg/ml 5ml N1; N10 Fresenius Hemocare<br />

Immuno Therapy<br />

20mg N30 KRKA<br />

10mg N30 KRKA<br />

250mg<br />

N8<br />

Innotech<br />

International<br />

522. Atropini sulfas 1% Atropini sulfas eye drops,sol. 10mg/ml 5ml Polfa Warsaw<br />

523. Atropino sulfato 0,1% tirpalas<br />

injekcijoms<br />

Atropini sulfas sol. for inj. 1mg/ml<br />

1ml amp. N10<br />

Endokrininiai<br />

preparatai<br />

524. Atropino sulfato 1% tirpalas Atropini sulfas eye drops, sol. 50mg/5ml Endokrininiai<br />

preparatai<br />

525. Atrovent Ipratropii bromidum sol. for inhal.,<br />

unit dose vials<br />

526. Atrovent Ipratropii bromidum sol. for inhal.,<br />

unit dose vials<br />

0,25mg/2ml N20; N60 Boehringer<br />

Ingelheim<br />

0,5mg/2ml N20; N60 Boehringer<br />

Ingelheim<br />

527. Atrovent Ipratropii bromidum nasal spray, sol. 62,6mg/ 100ml 15ml Boehringer<br />

Ingelheim<br />

528. Atrovent Ipratropii bromidum metered dose<br />

inhaler<br />

20µg/dose 300 doses (15ml) Boehringer<br />

Ingelheim<br />

529. Atrovent 0,025 % Ipratropii bromidum sol. for inhal. 250µg/ml 20ml Boehringer<br />

Ingelheim<br />

530. Atrovent N<br />

20 mcg<br />

531. Atsikose˙jima˛ gerinantis<br />

vaistazˇoliu˛ mišinys Nr. 3<br />

532. Atsikose˙jima˛ gerinantis<br />

vaistazˇoliu˛ mišinys Nr. 4<br />

Ipratropii bromidum metered dose<br />

inhaler<br />

Glycyrrhizae rad.+Foeniculi<br />

fruct.+Serpylli herb.<br />

Pini gemmae+<br />

Serpylli herb.+<br />

Sambuci flos<br />

20µg/dose<br />

200 doses<br />

herbal tea 40g+30g+<br />

30g; 5 g; 50g (2g× 25);<br />

44g (2g×22)<br />

herbal tea 40g+30g+<br />

30g; 50g;<br />

50g (2g× 25);<br />

44g (2g×22)<br />

Boehringer<br />

Ingelheim<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Švenčioniu˛<br />

vaistazˇole˙s


EN<br />

140 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

533. Atsikose˙jima˛ lengvinantis<br />

vaistazˇoliu˛ mišinys ‘Bronchos’<br />

534. Atsikose˙jima˛ lengvinantis<br />

vaistazˇoliu˛ mišinys<br />

‘Bronchos-1’<br />

535. Atsikose˙jima˛ lengvinantis<br />

vaistazˇoliu˛ mišinys Nr.2<br />

Thymi herba+Anysi- fructus+<br />

Verbasci flos<br />

Plantaginis lanceolata folium +<br />

Primulae radix+ Thymi herba<br />

Plantaginis majoris folium+<br />

Liquiritiae radix+Calendulae<br />

flos+Tiliae flos<br />

536. Atussin Dextrometorphani<br />

hydrobromidum+ Acidum<br />

ascorbicum<br />

537. Augmentin Amoxicillinum+ Acidum<br />

clavulanicum<br />

538. Augmentin Amoxicillinum+ Acidum<br />

clavulanicum<br />

539. Augmentin Amoxicillinum+ Acidum<br />

clavulanicum<br />

540. Augmentin Amoxicillinum+ Acidum<br />

clavulanicum<br />

541. Augmentin Amoxicillinum+ Acidum<br />

clavulanicum<br />

542. Augmentin Amoxicillinum+ Acidum<br />

clavulanicum<br />

543. Augmentin Amoxicillinum+ Acidum<br />

clavulanicum<br />

544. Augmentin Amoxicillinum+ Acidum<br />

clavulanicum<br />

545. Aurobin Prednisolonum+ Lidocainum+<br />

Dexpanthenolum+<br />

Triclosanum<br />

546. Aurocard Crataegus Ø+Aurum<br />

chloratum D4+Convallaria<br />

majalis D1+Ignatia D4+Arnica<br />

Ø<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

herbal tea 25g+50g+ 25g/100g 50g; 37g<br />

(1,5g×25)<br />

herbal tea 33,3g+33,3g+ 33,4g/100g<br />

37,5g (1,5g×25)<br />

herbal tea 20g+10g+<br />

10g+10g 100g; 50g; 50g<br />

(2g×25); 37,5g (1,5g×25); 25g<br />

(1g×25)<br />

Acorus Calamus<br />

Acorus Calamus<br />

Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

tablets 0,015g+ 0,1g N30;N120 SC ‘Concern Stirol’<br />

powder for sol.<br />

for i.v. inj.<br />

powder for oral<br />

susp.<br />

powder for oral<br />

susp.<br />

powder for oral<br />

susp.<br />

powder for oral<br />

susp.<br />

500mg+ 100mg N10 vials SmithKline Beecham<br />

80mg+ 11,4mg/ml 70ml SmithKline Beecham<br />

50mg+ 12,5mg/ml 100ml SmithKline Beecham<br />

40mg+ 5,7mg/ml 70ml SmithKline Beecham<br />

25mg+ 6,25mg/ml 100ml SmithKline Beecham<br />

film-coated tab. 875mg+ 125mg N14 SmithKline Beecham<br />

film-coated tab. 500mg+ 125mg N20 SmithKline Beecham<br />

powder for sol.<br />

for i.v. inj.<br />

1000mg+ 200mg N5 vials SmithKline Beecham<br />

ointment 40mg+400mg+400mg+<br />

20mg/20g<br />

oral drops,<br />

solution<br />

547. Avandia 1 mg Rosiglitazonum film-coated tab. 1mg<br />

N56<br />

548. Avandia 2 mg Rosiglitazonum film-coated tab. 2mg<br />

N56<br />

549. Avandia 4 mg Rosiglitazonum film-coated tab. 4mg<br />

N28; N56<br />

550. Avandia 8 mg Rosiglitazonum film-coated tab. 8mg<br />

N28<br />

4g+1g+1g+1g+50mg/10g<br />

(10,4ml) 30ml; 100ml<br />

Gedeon Richter<br />

DHU<br />

SB Pharmaco PR<br />

SB Pharmaco PR<br />

SB Pharmaco PR<br />

SB Pharmaco PR<br />

551. Avant Haloperidolum tab. 5mg N100; N500; N1000 Medochemie<br />

552. Avaxim Inactivated hepatitis A virus<br />

vaccine<br />

susp. for inj. 160 antigen units/0,5ml<br />

pre-filled syringe N1<br />

Aventis Pasteur<br />

553. Aviečiu˛ lapai (smulkinti) Fol. Rubi idaei herbal tea 100g; 50g Švenčioniu˛<br />

vaistazˇole˙s<br />

554. Aviete˙s lapai Fol. Rubi idaei herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 141<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

555. Aviomarin Dimenhydrinatum tab. 50mg N5 Pliva Krakow<br />

556. Aviral-200 Aciclovirum tab. 200mg N20 Mepha<br />

557. Aviral-400 Aciclovirum tab. 400mg N20 Mepha<br />

558. Aviral-800 Aciclovirum tab. 800mg N20 Mepha<br />

559. Avonex Interferonum<br />

beta-1a<br />

560. Axetine<br />

750 mg<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

30µg/vial Biogen<br />

Cefuroximum powder for inj. 750mg/vial N1; N10 Medochemie<br />

561. Axetine 1,5 g Cefuroximum powder for inj. 1,5g/vial N1; N10 Medochemie<br />

562. Axid Nizatidinum caps. 150mg N20; N28 Lilly<br />

563. Axid Nizatidinum caps. 300mg N10; N14; N28 Lilly<br />

564. Axid I.V. Nizatidinum sol. for inj. 100mg/4ml amp.N5 Eli Lilly<br />

565. Azatril<br />

250 mg<br />

Azithromycinum caps. 250mg<br />

N8<br />

566. Azillin 100 Amoxicillinum powder for oral<br />

drops<br />

567. Azillin 200 Amoxicillinum powder for<br />

syrup<br />

100mg/2ml 40ml Spirig<br />

200mg/5ml Spirig<br />

Balkanpharma-<br />

Razgrad<br />

568. Azitrox 250 Azithromycinum coated tablets 250mg N3;N6 Lečiva a.s.<br />

569. Azitrox 500 Azithromycinum coated tablets 500mg N3 Lečiva a.s.<br />

570. Azmacort Triamcinolonum metered dose<br />

aerosol<br />

200µg/dose 240 doses Rhone-Poulenc<br />

Rorer<br />

571. Azopt Brinzolamidum eye drops, susp. 10mg/ml 5ml Alcon<br />

572. Azulan Ethanol.-aquos.extr.ex<br />

anth.Chamomillae (Ethanolum<br />

65-72%)<br />

oral or topical<br />

sol.<br />

30g; 100g Herbapol Kle˛ce<br />

573. A˛zˇuolu˛ zˇieve˙ (smulkinta) Cortex Quercus herbal tea 100g; 50g; 16,8g (0,7g×24);<br />

24g (1g×24); 36g(1,5g×24);<br />

48g(2g×24);<br />

50g(2g×25)<br />

574. Babicum Extr. Plantaginis lanceolatae<br />

(1:1)<br />

575. Babydent Benzocainum+ Ethanolum<br />

96%<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

syrup 5g/100g 100ml NP Pharma<br />

sol. 30mg+1,5g/ 10ml Stada<br />

576. Baclofen Baclofenum tab. 25mg Polpharma<br />

577. Baclofen Baclofenum tab. 10mg N50 Polpharma<br />

578. Bactiflox-250 Lactab Ciprofloxacinum tab. 250mg N10; N20 Mepha<br />

579. Bactiflox-500 Lactab Ciprofloxacinum tab. 500mg N10; N20 Mepha<br />

580. Bactiflox-750 Ciprofloxacini hydrochloridum film-coated tab. 750mg<br />

N10<br />

Mepha


EN<br />

142 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

581. Bactox<br />

125 mg/5 ml<br />

582. Bactox<br />

250 mg/5 ml<br />

583. Bactox<br />

500 mg<br />

584. Bactox<br />

500 mg IM<br />

Pharmaceutical<br />

form<br />

Amoxicillinum powder for oral<br />

susp.<br />

Amoxicillinum powder for oral<br />

susp.<br />

Amoxicillinum caps., hard 500mg<br />

N12<br />

Amoxicillinum powder and<br />

solvent for sol.<br />

for inj.<br />

585. Bactox 1g IM Amoxicillinum powder and<br />

solvent for sol.<br />

for inj.<br />

586. Bactrim Sulfamethoxa-zolum+<br />

Trimethoprimum<br />

Strength Manufacturer<br />

125mg/5ml 1,5g(60ml) Innotech<br />

International<br />

250mg/5ml 3g(60ml) Innotech<br />

International<br />

500mg/vial and 1amp.of<br />

solvent (Benzyl alcohol<br />

150mg/5ml) N1<br />

1g/vial and 1amp. of solvent<br />

(Benzyl alcohol 150mg/5ml)<br />

N1<br />

syrup 200mg+ 40mg/5ml 100ml Roche<br />

Innotech<br />

International<br />

Innotech<br />

International<br />

Innotech<br />

International<br />

587. Balinio ajero zˇole˙ Herb.Calami herbal tea 100g Švenčioniu˛<br />

vaistazˇole˙s<br />

588. Balmandol bath oil Amygdalae oleum+Paraffinum<br />

liquidum<br />

589. Baneocin powder Bacitracinum zincum+<br />

Neomycini sulfas<br />

590. Baneocin ointment Bacitracinum zincum+<br />

Neomycini sulfas<br />

591. Barijodeel Barium carbonicum D12+<br />

Ignatia D6+ Datura<br />

stramonium D4+ Kalium<br />

phosphoricum D6 +Arnica<br />

montana D4 + Causticum<br />

Hahnemanni D6+ Semecarpus<br />

anacardium D6+ Aconitum<br />

napellus D12 + Calcium<br />

jodatum D4<br />

592. Barium sulfuricum suspensio<br />

pro Roentgeno<br />

593. BCG Vaccine Cultivable particles of<br />

attenuated living bacili,Merieux<br />

seed derived from the 1077<br />

strain<br />

594. BCG vaccine, SSI Mycobacterium Bovis (BCG)<br />

Danish 1331<br />

595. BCG-Vaccine 500 Behring Live attenuated Mycobacterium<br />

bovis bacteria, BCG (strain<br />

Copenhagen 1331)<br />

596. Beclazone<br />

50 µg<br />

597. Beclazone<br />

50 µg Easi-Breathe<br />

bath oil 300mg+ 693mg/g 225ml Spirig<br />

cutaneous<br />

powder<br />

250IU+ 5000IU/g 10g Siegfried Pharma<br />

ointment 250IU+ 5000IU/g 20g Merck<br />

tab. 30mg+ 30mg+ 30mg+ 30mg+<br />

30mg+ 45mg+ 45mg+ 45mg+<br />

15mg N50;N250<br />

Barii sulfas susp. 1g/ml 200ml Medana Pharma<br />

Terpol<br />

powder and<br />

solvent for<br />

susp.for inj.<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

Beclometasonum aerosol for<br />

inhal., susp.<br />

Beclometasonum aerosol for<br />

inhal., susp.<br />

598. Beclazone 100 µg Beclometasonum aerosol for<br />

inhal., susp.<br />

599. Beclazone 100 µg Easi-Breathe Beclometasonum aerosol for<br />

inhal., susp.<br />

800000-3200000 Units/dose<br />

(0,1ml) vial (10 doses)+ 1ml<br />

amp.of solvent N1;N10<br />

Heel<br />

Pasteur Merieux<br />

0,75mg/ml Statens Serum<br />

Institut<br />

susp. for inj. 300000-600000 VU/0,1ml N5<br />

po 1ml amp.<br />

50µg/dose 200doses Galena<br />

50µg/dose 200doses Galena<br />

100µg/dose 200doses Galena<br />

100µg/dose 200doses;<br />

3×200doses<br />

Chiron Behring<br />

Galena


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 143<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

600. Beclazone 250 µg Beclometasonum aerosol for<br />

inhal., susp.<br />

601. Beclazone 250 µg Easi-Breathe Beclometasonum aerosol for<br />

inhal., susp.<br />

Strength Manufacturer<br />

250µg/dose 200doses Galena<br />

250µg/dose 200doses;<br />

3×200doses<br />

602. Beclocort forte Beclometasonum aerosol 250µg/ dose 200 doses Glaxo Wellcome<br />

603. Beclocort mite Beclometasonum aerosol 50µg/dose 200 doses Glaxo Wellcome<br />

604. Becloforte Inhaler Beclometasonum Pressuri-sed<br />

metered dose<br />

inhaler<br />

605. Beclomet Easyhaler Beclometasonum inhala-tion<br />

powder<br />

250µg/dose N1 (80 and 200<br />

actuations)<br />

Galena<br />

Glaxo<br />

200µg/dose 200doses Orion<br />

606. Beclomet Nasal Aqua Beclometasonum nasal spray, sol. 100µg/dose (1,11mg/ml) 23ml Orion<br />

607. Beconase Beclometasonum aqueous nasal<br />

spray<br />

608. Becotide Beclometasonum Pressuri-sed<br />

metered dose<br />

ihhalers aerosol<br />

50µg/dose N1 (200 actuations) Glaxo<br />

50µg/dose<br />

80, 100 and 200 actuations<br />

609. Befunginum sol. Befunginum sol. 100ml Liuks<br />

610. Belara Chlormadinonum +<br />

Ethinylestradiolum<br />

film-coated<br />

tablets<br />

Glaxo<br />

2mg+30µg N21;N3×21 Grunenthal GmbH<br />

611. Belladonae extr. 0,015 g supp. Extr. Belladonnae supp. 0,015mg N10 Liuks<br />

612. Belladonna-Homaccord Atropa belladonna D2+ Atropa<br />

beladonna D10+Atropa<br />

belladona D30+ Atropa<br />

belladona D200+Atropa<br />

belladona D1000 +Echinacea<br />

angustifolia D10+ Echinacea<br />

angustifolia D30+ Echinacea<br />

angustifolia D200<br />

drops 0,5g+0,5g+ 0,5g+0,5g+ 0,5g+<br />

0,5g+ 0,5g+ 0,5g/100g<br />

(Ethanolum 35 vol.-%) 30ml;<br />

100ml<br />

613. Bellalginum Compositum tab. N10 Liuks<br />

614. Bellasthesinum tab. Compositum tab. N10; N20; N30; N50; N60 Liuks<br />

615. Benemicin Rifampicinum caps. 150mg<br />

N100<br />

Heel<br />

Polfa Tarchomin<br />

616. Benemicin Rifampicinum caps. 300mg N100 Polfa Tarchomin<br />

617. Benfogamma Benfotiaminum drag. 50mg<br />

N50<br />

618. Bengay neriebus skausma˛<br />

malšinantis kremas<br />

Methylis salicylas+ Mentholum cream 15%+10% 57g Pfizer<br />

619. Benzylbenzoat Benzylis benzoas ointment 20g/100g<br />

30g<br />

620. Bepanthen Cream Dexpanthenolum cream 50mg/g<br />

30 g<br />

621. Bepanthen ointment 5 % Dexpanthenolum ointment 50mg/g<br />

30g<br />

622. Bepanthen Plus Dexpanthenolum+<br />

Chlorhexidinum<br />

Worwag Pharma<br />

Tallinna<br />

Farmaatsiatehase<br />

Roche<br />

Roche<br />

cream 50mg+5mg/g 30g Roche


EN<br />

144 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

623. Berberis-Homaccord Berberis vulgaris D2+Berberis<br />

vulgaris D10+ Berberis vulgaris<br />

D30+Berberis vulgarisD200+<br />

Citrullus colocynthis D2+<br />

Citrullus colocynthis D10+<br />

Citrullus colocynthis D30+<br />

Citrullus colocynthis D200 +<br />

Veratrum album D3+Vertrum<br />

album D10+ Veratrum album<br />

D30<br />

624. Bericaps Vaccinum macrocarpon<br />

concentrate<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

drops 0,4g+0,4g+ 0,4g+0,4g+ 0,3g+<br />

0,3g+ 0,3g+0,3g+ 0,3g+0,3g+<br />

0,3g+ 0,3g/100g 30ml; 100ml<br />

Heel<br />

caps. 400 mg Sanitas<br />

625. Berlidorm 5 Nitrazepamum tab. 5mg N10; N20 Berlin-Chemie<br />

626. Berlipril 10 Enalaprilum tab. 10mg N30; N50; N100 Berlin-Chemie<br />

627. Berlipril 20 Enalaprilum tab. 20mg N30; N50; N100 Berlin-Chemie<br />

628. Berlipril 5 Enalaprilum tab. 5mg N20; N30; N50; N100 Berlin-Chemie<br />

629. Berlocid 240 Sulfamethoxazolum+<br />

Trimethoprimum<br />

630. Berlocid 480 Sulfamethoxazolum+<br />

Trimethoprimum<br />

631. Berlocid 960 Trimethoprimum+<br />

Sulfamethoxazolum<br />

632. Berocca Calcium and<br />

Magnesium effervescent tablets<br />

Thiaminum+<br />

Riboflavinum+ Pyridoxinum+<br />

Cyanocobalaminum+<br />

Acidum ascorbicum+<br />

Biotinum+Acidum<br />

pantothenicum+<br />

Nicotinamidum+<br />

Calcium+Magnesium<br />

633. Berodual Ipratropii bromidum+<br />

Fenoterolum<br />

634. Berodual Ipratropii bromidum+<br />

Fenoterolum<br />

635. Berodual N Ipratropii bromidum+<br />

Fenoterolum<br />

oral susp. 4g+0,8g/100ml Berlin-Chemie<br />

(Menarini Group)<br />

tab. 80mg+ 400mg N10; N20;<br />

N30<br />

tab. 160mg+ 800mg N10; N20;<br />

N30<br />

efferv.tab. 15mg+15mg+10mg+ 10µg+<br />

1000mg+150µg+ 50mg+<br />

23mg+100mg+<br />

100mg N10;N20<br />

metered dose<br />

inhaler<br />

20µg+50µg/ dose 15ml (300<br />

puffs)<br />

sol. for inhal. 250µg+<br />

500µg/ml 20ml<br />

metered dose<br />

inhaler<br />

636. Berotec Fenoterolum inhal. sol. 1mg/ml<br />

20ml<br />

637. Berotec<br />

200 mcg<br />

Fenoterolum metered dose<br />

inhaler<br />

638. Berotec Fenoterolum inhal. sol., unit<br />

dose vial<br />

639. Berotec Fenoterolum inhal. sol., unit<br />

dose vial<br />

640. Berotec 100 Fenoterolum metered dose<br />

inhaler<br />

641. Berotec N 100 mcg Fenoterolum metered dose<br />

aerosol<br />

642. Berubi compositum N Thiaminum+Riboflavinum+<br />

Pyridoxinum+<br />

Cyanocobalaminum+Calcii<br />

pantothenas +Ferri (II)gluconas<br />

21µg+50µg/ dose 200 doses<br />

10ml<br />

Berlin-Chemie<br />

Berlin-Chemie<br />

Roche<br />

Boehringer<br />

Ingelheim<br />

Boehringer<br />

Ingelheim<br />

Boehringer<br />

Ingelheim<br />

Boehringer<br />

Ingelheim<br />

200µg/dose 200 doses Boehringer<br />

Ingelheim<br />

1,25mg/2ml N10; N60 Boehringer<br />

Ingelheim<br />

0,5mg/2ml N10; N60 Boehringer<br />

Ingelheim<br />

100µg/dose 15 ml 300doses<br />

N1<br />

Boehringer<br />

Ingelheim<br />

100µg/dose 200doses (10ml) Boehringer<br />

Ingelheim<br />

sol. 15mg+10mg+ 5mg+0,2µg+<br />

15mg+300mg/ 100ml<br />

Redel


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 145<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

643. Berzˇu˛ pumpurai Gemm. Betulae herbal tea 50g Švenčioniu˛<br />

vaistazˇole˙s<br />

644. Berzˇu˛ pumpurai Gemm. Betulae herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

645. Betac Betaxololum film-coated<br />

tablets<br />

646. Betacorton Halcinonidum sol. 1mg/ml<br />

25ml; 100ml<br />

20mg N30 Medochemie Ltd.<br />

647. Betacorton Cream Halcinonidum+ Ureum cream 1mg+50mg/g 20g; 50g Spirig<br />

648. Betacorton Fatty Cream Halcinonidum+ Ureum fatty cream 1mg+100mg/g 20g; 50g Spirig<br />

649. Betacorton S Halcinonidum+ Acidum<br />

salicylicum<br />

650. Betadine Povidonum iodinatum<br />

(Polyvidonum)<br />

651. Betadine Povidonum iodinatum<br />

(Polyvidonum)<br />

652. Betadine Povidonum iodinatum<br />

(Polyvidonum)<br />

653. Betadrin Diphenhydramini<br />

hydrochloridum+ Naphazolini<br />

nitras<br />

654. Betaferon Interferonum<br />

beta-1b<br />

655. Betaklav Amoxicillinum+<br />

Acidum clavulanicum<br />

656. Betaklav Amoxicillinum+<br />

Acidum clavulanicum<br />

657. Betaklav Duo Amoxicillinum+ Acidum<br />

clavulanicum<br />

Spirig<br />

sol. 1mg+20mg/ml 25ml; 100ml Spirig<br />

sol. 100mg/ml 30ml; 120ml;<br />

1000ml<br />

vaginal supp. 200mg<br />

N14<br />

ointment 100mg/g<br />

20g<br />

Egis<br />

Egis<br />

Egis<br />

eye drops, sol. 1mg+ 0,33mg/ml 5ml Polfa Warsaw<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

powder for oral<br />

sol.<br />

0,25mg (8 MIU)/ml+ 1 vial of<br />

solvent N15<br />

250mg+<br />

62,5mg/5ml 100ml<br />

tab. 500mg+<br />

125mg<br />

N14; N21<br />

Chiron or<br />

Boehringer<br />

Ingelheim<br />

KRKA<br />

KRKA<br />

tablets 875mg+125mg N14 KRKA<br />

658. Betaloc Metoprololum sol. for i.v. inj. 1mg/ml<br />

5ml amp. N5<br />

659. Betaloc ZOK Metoprololum prolongedrelease<br />

tablet<br />

660. Betalok ZOK Metoprololum controlledrelease<br />

tab.<br />

661. Betalok ZOK Metoprololum controlledrelease<br />

tab.<br />

AstraZeneca<br />

25mg N14 AstraZeneca<br />

50mg<br />

N30; N100<br />

100mg<br />

N30; N100<br />

662. Betamaks Sulpiridum film-coated tab. 100mg N30 Sawai<br />

Pharmaceutical<br />

663. Betamaks Sulpiridum film-coated tab. 50mg N30 Sawai<br />

Pharmaceutical<br />

664. Betamaks Sulpiridum film-coated tab. 200mg N30 Sawai<br />

Pharmaceutical<br />

665. Betaserc Betahistinum tab. 8mg N100 Solvay<br />

Pharmaceuticals<br />

Astra<br />

Astra


EN<br />

146 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

666. Betaserc Betahistinum tab. 16mg N60 Solvay<br />

Pharmaceuticals<br />

667. Betaserc 24mg Betahistidini dihydrochloridum scored tablets 24mg N20; N50; N100 Solvay<br />

Pharmaceuticals B.V.<br />

668. Betnesol Betamethasonum eye, ear or nasal<br />

drops<br />

5mg/5ml<br />

5ml<br />

Glaxo Wellcome<br />

669. Betnovate Betamethasonum lotion 1,22mg/g 20ml Glaxo Wellcome<br />

670. Betnovate cream Betamethasonum cream 10mg/g<br />

15g<br />

671. Betnovate ointment Betamethasonum ointment 10mg/g<br />

15g<br />

672. Betoptic Betaxololum eye drops, sol. 5mg/ml<br />

5ml<br />

Glaxo<br />

Glaxo<br />

Alcon-Couvreur<br />

673. Betoptic S Betaxololum eye drops, susp. 2,5mg/ml Alcon-Couvreur<br />

674. Biafine Trolaminum emuls. 6,7mg/g 46,5g; 93g; 186g Laboratoire Medix<br />

675. Bičiu˛ pienelis (apilakas) Apilacum naturale tab. 75mg N20 Medicata filia<br />

676. Bifidumbakte-rino kapsule˙s Bifidobacterium bifidum caps. 2×10 7 N10;N30 Bakteriniai<br />

preparatai<br />

677. Bifonazol-SL crm. Bifonazolum cream 10mg/g 15g tube Slovakofarma<br />

678. Bifonazol-SL shp. Bifonazolum shampoo 10mg/g<br />

100g<br />

679. Bilobil Ginkgo bilobae folii extractum<br />

siccum<br />

680. Bilobil Forte Ginkgo bilobae folii extractum<br />

siccum<br />

681. Bilosan Ginkgo bilobae folii extractum<br />

siccum<br />

682. Bilosan Plus Extr. Gingko Biloba+<br />

Extr. Panax ginseng<br />

683. Bioaron C Aloe extractum fluidum<br />

aqnosus (1=4)+Aroniae succus<br />

(1=1)+Acidum ascorbicum<br />

684. Bio-Biloba Extr.Ginkgo bilobae (Flavoneglycosi-des+Terpenelactones)<br />

caps. 40mg N20;N60 KRKA<br />

Slovakofarma<br />

capsules 80mg N20;N60 KRKA, d.d., Novo<br />

mesto<br />

capsules 40mg N30;N60;N90 Sanitas AB<br />

caps. 60mg + 100mg Sanitas<br />

syrup 1920mg+ 1170mg+<br />

51mg/5ml 150g;100ml<br />

tab. 105mg (24mg+6mg) N30;<br />

N60;<br />

N150<br />

685. Biodacyna Amikacinum sol. for inj. 1g/4ml vial<br />

N1<br />

686. Biodacyna Amikacinum sol. for inj. 500mg/2ml<br />

vial N1<br />

687. Biodacyna Amikacinum sol. for inj. 250mg/2ml<br />

vial N1<br />

688. Biodroxil Cefadroxilum gran for oral<br />

susp.<br />

Phytopharm Kle˛ka<br />

Spolka Akcyjna<br />

Pharma Nord<br />

Bioton<br />

Bioton<br />

Bioton<br />

125mg/5ml 60ml Biochemie<br />

689. Biodroxil Cefadroxilum caps. 500mg N12 Biochemie<br />

690. Biodroxil Cefadroxilum film-coated tab. 1000mg<br />

N12<br />

Biochemie


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 147<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

691. Biodroxil 250mg/5ml Cefadroxilum powder for oral<br />

suspension<br />

692. Biofuroksym 0,75 g Cefuroximum powder for sol.<br />

for inj.<br />

693. Biofuroksym 1,5 g Cefuroximum powder for sol.<br />

for i. v. inj.<br />

694. Biofuroxym Cefuroximum powder for<br />

solution for<br />

injection<br />

695. Biofuroxym Cefuroxium powder for<br />

solution for<br />

injection<br />

696. Bioline Cold relief compos. tablets<br />

sublingvalis<br />

697. Bioline Insomnia relief compos. tablets<br />

sublingvalis<br />

698. Bioline Pain relief compos. tablets<br />

sublingvalis<br />

Strength Manufacturer<br />

250mg/5ml 60ml Biochemie<br />

750mg N1 Instytut<br />

Biotechnologii i<br />

Antibiotykow<br />

1,5g N1 Instytut<br />

Biotechnologii i<br />

Antibiotykow<br />

1,5g/vial N1 Bioton Sp.z o. o.<br />

750mg/vial N1 Bioton Sp.z o. o.<br />

N50 Botanical<br />

Laboratories Inc.<br />

N50 Botanical<br />

Laboratories Inc.<br />

N50 Botanical<br />

Laboratories Inc.<br />

699. Bioparox Fusafunginum aerosol 0,125mg/dose 400 doses Egis<br />

700. Biosoma Hormonum incrementi<br />

humanum recombinatum<br />

701. Biosoma Hormonum incrementi<br />

humanum recombinatum<br />

702. Biosoma Hormonum incrementi<br />

humanum recombinatum<br />

703. Biosoma Hormonum incrementi<br />

humanum recombinatum<br />

704. Biotaksym Cefotaximum powder for sol.<br />

for. inj.<br />

705. Biotrakson Ceftriaxonum powder for sol.<br />

for inj.<br />

706. Biotum Ceftazidimum powder for sol.<br />

for inj.<br />

for inj., dried 8UI/vial N1 (Alcohol<br />

benzylicus 19,8mg/2,2ml<br />

amp.)<br />

for inj., dried 12UI/vial N1<br />

(Alcohol benzylicus<br />

39,6mg/4,4ml amp.)<br />

for inj., dried 16UI/vial<br />

N1 (Alcohol benzylicus<br />

39,6mg/4,4ml amp.)<br />

for inj., dried 4UI/vial N1 (Alcohol<br />

benzylicus 18mg/2ml amp.)<br />

Biotechna<br />

Biotechna<br />

Biotechna<br />

Biotechna<br />

1g/vial N1 Bioton<br />

1g/vial<br />

N1<br />

707. Bisacodyl Bisacodylum coated tab. 5mg<br />

N30<br />

Bioton<br />

1g N1 Instytut<br />

Biotechnologii i<br />

Antibiotykow<br />

ICN Polfa Rzeszow<br />

708. Bisacodyl Bisacodylum supp. 10mg N10 Glaxo Wellcome<br />

709. Bisacodyl Bisacodylum enteric-coated<br />

tab.<br />

5mg<br />

N30<br />

Balkanpharma-<br />

Dupnitza<br />

710. Bisakodils Bisacodylum tab. 5mg N20; N40 Grindeks<br />

711. Biseptol Sulfamethoxazolum+<br />

Trimethoprimum<br />

712. Biseptol 120 Sulfamethoxazolum+<br />

Trimethoprimum<br />

Oral susp. 200mg+40mg/5ml<br />

80ml<br />

Medana Pharma<br />

Terpol<br />

tab. 100mg+ 20mg N20 Polfa Pabianice


EN<br />

148 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

713. Biseptol 480 Sulfamethoxazolum+<br />

Trimethoprimum<br />

714. Biseptol 480 Sulfamethoxazolum+<br />

Trimethoprimum<br />

715. Biseptol 960 Sulfamethoxazolum+<br />

Trimethoprimum<br />

716. Bisoprolol-ratiopharm<br />

10 mg<br />

717. Bisoprolol-ratiopharm<br />

5mg<br />

Pharmaceutical<br />

form<br />

sol. for inf. 80mg+ 16mg/ml 5ml amp.<br />

N10<br />

Bisoprololum tab. 10mg<br />

N30<br />

Bisoprololum tab. 5mg<br />

N30<br />

718. Bitter salt Magnesii sulfas powder for oral<br />

sol.<br />

719. Blemaren Acidum citricum+ Kalii<br />

hydrogencarbonas+ Natrii<br />

citras<br />

720. Blemaren N Kalii hydrogencarbonas+<br />

Acidum citricum+ Natrii citras<br />

Strength Manufacturer<br />

Polfa Warsaw<br />

tab. 400mg+ 80mg N20 Polfa Pabianice<br />

tab. 800mg+ 160mg N10 Polfa Pabianice<br />

gran. for oral<br />

sol.<br />

721. Bleocin Bleomycinum powder for sol.<br />

for inj.<br />

722. Bleolem Bleomycini sulfas powder and<br />

solvent for sol.<br />

for inj.<br />

Merckle<br />

Merckle<br />

25g Galenus<br />

39,9g+ 32,25g+ 27,85g/100g<br />

200g<br />

efferv. tab. 967,5mg+ 1197mg+ 835,5mg<br />

N80<br />

15mg<br />

N1<br />

723. Bom-Benge tepalas Mentholum+ Methylis salicylas ointment 39mg+<br />

202mg/g<br />

25g; 40g<br />

15 U/vial +5ml amp. (water<br />

for inj.) N1<br />

Esparma<br />

Esparma<br />

Nippon Kayaku<br />

Lemery<br />

724. Bondronat Acidum ibandronicum conc. for inf. 1mg/ml N5 Boehringer<br />

Mannheim<br />

725. Bondronat Acidum ibandronicum conc. for inf. 2mg/2ml N5 Boehringer<br />

Mannheim<br />

726. Bonefos Acidum clodronicum tab. 800mg N60 Leiras<br />

727. Bonefos Dinatrii clodronas caps. 400mg<br />

N30; N100<br />

728. Bonefos Dinatrii clodronas conc. for sol.<br />

for inf.<br />

729. Bonine Meclozinum chewable tab. 25mg<br />

N8<br />

730. Boostrix (combined diphtheria,<br />

tetanus, acellular pertussis<br />

vaccine)<br />

Diphtheria toxoid+<br />

Tetanus toxoid+<br />

Pertussis toxoid+<br />

Filamentous haemagglutinin+<br />

Pertactin<br />

60mg/ml<br />

5ml amp. N5<br />

susp. for inj. >=2IU+ >=20IU+8µg+<br />

8µg+2,5µg/<br />

0,5ml pre-filled syringe<br />

N1<br />

Sanitas<br />

Leiras<br />

Leiras<br />

Pfizer<br />

GlaxoSmith<br />

Kline Biologicals<br />

731. Boric Acid Acidum boricum subst. 25kg Kirsch Pharma<br />

732. Boro rūgšties 1 % etanolinis<br />

tirpalas<br />

733. Boro rūgšties 2 % etanolinis<br />

tirpalas<br />

734. Boro rūgšties etanolinis<br />

3 % tirpalas<br />

Acidum boricum + Ethanolum<br />

70%<br />

sol. 10g<br />

(ad 1000ml) 40ml<br />

Vilniaus f.f.<br />

Acidum boricum sol. 2g/100ml 10ml; 40ml; 4,5kg Sanitas<br />

Acidum boricum + Ethanolum<br />

70%<br />

sol. 30g +ad 1000ml; 10ml Vilniaus f.f.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 149<br />

No. Commercial name General name<br />

735. Boromentolis Acidum boricum+<br />

Mentholum<br />

Pharmaceutical<br />

form<br />

736. Brevibloc Esmololum concentrate for<br />

inf.<br />

Strength Manufacturer<br />

ointment 5g+0,5g/100g 25g Sanitas<br />

250mg/ml 10ml N1 Faulding Puerto Rico<br />

737. Brevibloc Esmololum inj. 10mg/ml 10ml N5 Faulding Puerto Rico<br />

738. Brexin Piroxicamum scored tab. 20mg N20 Chiesi Farmaceutici<br />

739. Brexin Piroxicamum oral powder 20mg/double-pocket sachet<br />

(3g) N20<br />

740. Brietal Sodium Methohexitalum natricum powder for sol.<br />

for inj.<br />

741. Briliantinio Zˇaliojo 1%<br />

etanolinis tirpalas<br />

Viride nitens + Ethanolum<br />

60%<br />

Chiesi Farmaceutici<br />

500mg/vial N1 Lilly Pharma<br />

Fertigung<br />

sol. 1g +ad 100ml 10ml Bakteriniai<br />

preparatai<br />

laboratorija Galen<br />

742. Bromazepam Bromazepamum film-coated tab. 3mg N20; N50 Lannacher<br />

743. Bromazepam Bromazepamum film-coated tab. 6mg N20; N50 Lannacher<br />

744. Bromergon tablets<br />

2,5 mg<br />

Bromocriptinum tab. 2,5mg<br />

N30<br />

745. Bromheksinas 4 Bromhexin tab. 4 mg N20; N30; N50 Liuks<br />

746. Bromheksinas 8 Bromhexin tab. 8 mg N20; N30; N50 Liuks<br />

747. Bromheksins<br />

4 mg vaikams<br />

748. Bromheksins<br />

8mg<br />

Bromhexinum tab. 4mg<br />

N50<br />

Bromhexinum tab. 8mg<br />

N50<br />

749. Bromheksins sirups Bromhexinum sir. 4mg/5ml (Ethanolum 96%<br />

0,625ml/5ml) 100ml<br />

Lek<br />

Grindeks<br />

Grindeks<br />

Grindex<br />

750. Bromhexin Bromhexinum drag. 4mg N25; N50 Salutas<br />

751. Bromhexin Bromhexinum tab. 8mg<br />

N20<br />

Balkanpharma-<br />

Dupnitza<br />

752. Bromhexin 10 BC Bromhexinum sol. 10mg/5ml 100ml Berlin-Chemie<br />

(Menarini Group)<br />

753. Bromhexin 12 Bromhexinum tab. 12mg N25; N50 Salutas<br />

754. Bromhexin 4 BC Bromhexinum oral sol. 4mg/5ml 100ml Berlin-Chemie<br />

755. Bromhexin 8 Bromhexinum tab. 8mg N25; N50 Salutas<br />

756. Bromhexin 8 BC Bromhexinum sol. 8mg/5ml 100ml Berlin-Chemie<br />

(Menarini Group)<br />

757. Bromhexin 8 Berlin-Chemie Bromhexinum drag. 8mg<br />

N25; N50<br />

758. Bromhexin 8 Tropfen Bromhexinum+ Foeniculi<br />

aetherolum+ Anisi aetherolum<br />

(Ethanolum 41%)<br />

oral drops, sol. 8mg+0,74mg+0,25mg/ml<br />

20ml; 50ml; 100ml<br />

Berlin-Chemie<br />

Krewel Meuselbach<br />

759. Bromocriptine Poli Bromocriptinum tab. 2,5mg N30; N100 Poli Industria<br />

Chimica<br />

760. Bromocriptin-Richter Bromocriptinum tab. 2,5mg<br />

N30<br />

Gedeon Richter


EN<br />

150 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

761. Bronchalis-Heel Atropa belladonna D4+Sticta<br />

D4+ Kalium ctibyltartaricum<br />

D4+Kreosotum D5+<br />

Ipecacuanha D4+Lobelia<br />

inflata D4 +Hyoscyamus niger<br />

D4 +Bryonia cretica D4<br />

762. Bronchial fix Althaeae radicis+ Plantaginis<br />

lanceolatae folium+Tiliae flos<br />

763. Bronchicum Elixir Grindeliae herbae tinctura (1:5)<br />

+ Pimpinelae radicis tinctura<br />

(1:5) +Pri-mulae radicis<br />

tinctura (1:5) +Quebracho<br />

corticis tinctura (1:5)+Thymi<br />

herbae tinctura (1:5)<br />

Pharmaceutical<br />

form<br />

tab. 30mg+30mg+30mg+ 30mg+<br />

30mg+30mg+ 60mg+60mg<br />

N50; N250<br />

herbal tea 1 500mg +750mg+<br />

750mg/sachets (3g) N20<br />

sol. 1ml+0,2ml+ 0,7ml+0,7ml+<br />

1ml/100ml 100ml<br />

Strength Manufacturer<br />

Heel<br />

Herba Humana<br />

Nattermann<br />

764. Bronchicum Husten-Pastillen Thymi extractum fluidum lozenges 100mg N20 Nattermann<br />

765. Bronchicum Hustensirup Grindeliae herbae tinctura<br />

(1:5)+ Pimpinellae radicis<br />

tinctura (1:5)+ Primulae radicis<br />

tinctura (1:5)+ Rosae floris<br />

tinctura (1:5)+ Thymi herbae<br />

tinctura (1:5)<br />

syrup 0,2ml+0,2ml+ 1ml+1ml+<br />

1,2ml/100ml (Ethanolum<br />

1,8 % (V/V))<br />

766. Bronchocin Glaucinum+ Ephedrinum syrup 0,125g+<br />

0,1g/125g<br />

767. Broncho-Munal Lyophylized bacterial lyzate caps. 7mg<br />

N10; N30<br />

768. Broncho-Munal Lyophylized bacterial lyzate caps. 3,5mg<br />

N10; N30<br />

769. Bronchopront Ambroxolum oral drops, sol. 7,5mg/ml 50ml Mack<br />

770. Bronchopront Ambroxolum syrup 15mg/5ml 100ml Mack<br />

771. Bronchopront Ambroxolum sustainedrelease<br />

caps.<br />

772. Bronchosan Bromhexinum+ Mentholum+<br />

Foeniculi aetheroleum+Anisi<br />

oleum+Origani aetheroleum+<br />

Menthae piperitae oleum+<br />

Eucalypti aetheroleum<br />

75mg<br />

N10; N20; N50<br />

oral drops 8mg+1,5mg+ 0,75mg+<br />

0,25mg+ 0,25mg+ 0,25mg+<br />

0,25mg/g (Ethanolum 36%<br />

(V/V)) 25ml<br />

Nattermann<br />

Balkanpharma-<br />

Troyan<br />

Lek<br />

Lek<br />

Mack<br />

Slovakofarma<br />

773. Brontex lašai Ambroxolum sol. 7,5mg/ml 100ml Merckle<br />

774. Brontex sirupas Ambroxolum oral sol. 15mg/5ml 100ml Merckle<br />

775. Brontex tablete˙s Ambroxolum tab. 30mg N20 Merckle<br />

776. Brukniu˛ lapai Fol. Vitis idaeae herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

777. Brulamycin Tobramycini sulfas sol. for inj. 40mg/ml N10 Biogal<br />

778. Brulamycin Tobramycinum sol. for inj. 80mg/2ml N10 Biogal<br />

779. Bryaconeel Bryonia cretica D4+Aconitum<br />

napellus D4+ Phosphorus D5<br />

780. B-tabs, Multi-tabs Thiaminum+ Riboflavinum+<br />

Pyridoxinum+<br />

Cyanocobalaminum+<br />

Nicotinamidum+ Calcii<br />

pantothenas + Acidum folicum<br />

tab. 120mg+ 150mg+ 30mg N50;<br />

N250<br />

tab. 15mg+ 15mg+ 15mg+ 5µg+<br />

60mg+30mg+ 200µg N100<br />

Heel<br />

Ferrosan


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 151<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

781. Budenofalk Budesonidum caps. with<br />

gastroresistant<br />

pellets<br />

Strength Manufacturer<br />

3mg N50;N100 Falk/ Losan<br />

782. Budesonid forte Budesonidum aerosol 200µg/ dose 200 doses Glaxo Wellcome<br />

783. Budesonid mite Budesonidum aerosol 50µg/dose 200 doses Glaxo Wellcome<br />

784. Bunondol Buprenorphinum inj. 0,3mg/ml N5 Polfa Warsaw<br />

785. Bunondol Buprenorphinum sublin-gual tab. 0,4mg N30; N60 Polfa Warsaw<br />

786. Bunondol Buprenorphinum sublin-gual tab. 0,2mg N60 Polfa Warsaw<br />

787. Bupivacainum hydrochloricum<br />

0,5 %<br />

788. Bupivakaino 0,25 % tirpalas<br />

injekcijoms<br />

Bupivacainum sol. for inj. 5mg/ml 10ml amp. N10 Polfa Warsaw<br />

Bupivacainum sol. for inj. 2,5mg/ml<br />

20ml N5<br />

789. Bupivakaino 0,5 % tirp. inj. Bupivacaini hydrochloridum sol. for inj.<br />

spinale<br />

790. Bupivakaino 0,5 % tirpalas<br />

injekcijoms<br />

Bupivacainum sol. for inj. 5mg/ml<br />

20ml N5<br />

Delta/ Ilsanta<br />

0,5 % Endokrininai<br />

preparatai<br />

791. Burana Ibuprofenum tab. 200mg N20 Orion<br />

792. Burana Ibuprofenum tab. 400mg N20 Orion<br />

Delta/ Ilsanta<br />

793. Buronil Melperonum drag. 50mg N100 Lundbeck<br />

794. Buronil Melperonum drag. 100mg N100 Lundbeck<br />

795. Buronil Melperonum drag. 25mg N100 Lundbeck<br />

796. Buscopan<br />

10 mg<br />

797. Buscopan<br />

10 mg<br />

Hyoscini-N-butylbromidum sugar-coated<br />

tab.<br />

10mg<br />

N20<br />

Hyoscini-N-butylbromidum supp. 10mg<br />

N10<br />

Boehringer<br />

Ingelheim<br />

Boehringer<br />

Ingelheim<br />

798. Buspar Buspironum tab. 10mg N100 Bristol-Myers Squibb<br />

799. Buspar Buspironum tab. 5mg N30 Bristol-Myers Squibb<br />

800. Butadion 5 % Phenylbutazonum ointment 50mg/g<br />

20g<br />

801. Buventol Easyhaler Salbutamolum inhalation<br />

powder<br />

802. Buventol Easyhaler Salbutamolum inhalation<br />

powder<br />

100µg/dose 200doses Orion<br />

200µg/dose 200doses Orion<br />

803. Byanodine Penicillaminum caps. 150mg N40 Biogal<br />

804. Byol Bisoprololum film-coated<br />

tablets<br />

805. Byol Bisoprololum film-coated<br />

tablets<br />

Gedeon Richter<br />

10mg N30 Lek Pharmaceutical<br />

and Chemical<br />

Company d.d.<br />

5mg N30 Lek Pharmaceutical<br />

and Chemical<br />

Company d.d.<br />

806. C*Pharm 02010 Glucosum subst. Cerestar Iberica<br />

807. Ca-C 1000 Sandoz (orange) Calcii carbonas+ Calcii<br />

gluconolactas+ Acidum<br />

ascorbicum<br />

efferv. tab. 327mg+ 1g+1g N10 Novartis Pharma


EN<br />

152 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

808. Calcigran Calcium+ Colecalciferolum tab. 500mg+ 200IU N100 Nycomed Pharma/<br />

Nycomed SEFA<br />

809. Calcigran Forte (lemon taste) Calcium+ Colecalciferolum chewable tab. 500mg+ 400IU N60 Nycomed Pharma/<br />

Nycomed SEFA<br />

810. Calcimax 500 (apelsinu˛<br />

skonio)<br />

Calcii carbonas (Calcium) chewable tab. 1250mg (500mg) N60;N100 Nycomed Pharma/<br />

Nycomed SEFA<br />

811. Calcitonin 200 Calcitoninum salmonis nasal spray,<br />

solution<br />

200 IU/dose 14 doses;<br />

28 doses<br />

Istituto Biochimico<br />

Nazionale SAVIO<br />

s.r.l.<br />

812. Calcium Chloride Hexahydrate Calcii chloridum subst. 25kg Kirsch Pharma<br />

813. Calcium syrup Calcium gluco -<br />

nolactobionicum+<br />

Calcium lactobionicum<br />

syrup 29,4g+ 6,4g/100ml 150ml Hasco-Lek<br />

814. Calciumacetat-Nefro 500mg Calcii acetas film-coated tab. 500mg<br />

N100; N500<br />

815. Calciumfolinat ‘Ebewe’<br />

100 mg<br />

Medice<br />

Acidum folicum sol. for inj. 100mg/10ml vial N1 Ebewe<br />

816. Calciumfolinat ‘Ebewe’ 15 mg Acidum folicum caps., hard 15mg<br />

N20<br />

817. Calciumfolinat ‘Ebewe’ 3 mg Acidum folicum sol. for inj. 3mg/ml 1ml amp. N10 Ebewe<br />

818. Calciumfolinat ‘Ebewe’ 30 mg Acidum folicum sol. for inj. 30mg/3ml amp. N5 Ebewe<br />

819. Calcoheel Calcium carbonicum<br />

Hahnemanni D8 +Solanum<br />

dulcamara D6+ Chamomilla<br />

recutita D4+Carbo vegetabilis<br />

D12<br />

820. Cal-C-Vita Acidum ascorbicum +<br />

Calcium+ Pyridoxinum+<br />

Colecalciferolum<br />

tab. 180mg+30mg+30mg+ 60mg<br />

N50; N250<br />

efferv. tab. 1000mg+250mg+15mg+<br />

300IU N10<br />

821. Calendoderm Calendula Ø cream 1g/10g 50g;100g; 200g DHU<br />

822. Calgel teething gel Lidocainum+Cetylpyridinii<br />

chloridum<br />

Ebewe<br />

Heel<br />

Roche Nicolas<br />

gel 3,3mg+1mg/g 10g Glaxo Wellcome<br />

823. Calidiol Estradiolum nasal spray 150µg/dose 60 doses Les Laboratoires<br />

Delmas<br />

824. Calperos Calcii carbonas suckable tab. 500mg N60 Doms Adrian<br />

825. Calperos D3 Calcii carbonas+Colecalciferolum<br />

suckable tab. 1250mg+<br />

500mg<br />

N60<br />

Doms Adrian<br />

826. Calpol Paracetamolum supp. 125mg N10 Glaxo Wellcome<br />

Poznan<br />

827. Calpol six plus suspension Paracetamolum oral susp. 250mg/5ml 100ml Wellcome<br />

828. Calpol sugar-free infant<br />

suspension<br />

829. Caltrate Plus Vit.D+Calcium+ Magnesium+<br />

Zincum+ Cuprum+<br />

Manganum+ Borum<br />

Paracetamolum oral susp. 120mg/5ml 140ml Wellcome<br />

film-coated tab. 200IU+600mg+40mg+<br />

7,5mg+1mg+1,8mg+ 250µg<br />

N30; N60; N100<br />

Delavau


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 153<br />

No. Commercial name General name<br />

830. Caltrate Plus Chewables Vit.D+Calcium+ Magnesium +<br />

Zincum+ Cuprum+<br />

Manganum+ Borum<br />

Pharmaceutical<br />

form<br />

chewable tab. 200IU+600mg+40mg+<br />

7,5mg+1mg+1,8mg+ 250µg<br />

N30; N60; N100<br />

Strength Manufacturer<br />

Delavau<br />

831. Calypsol Ketaminum sol. for inj. 500mg/10ml vial N5 Gedeon Richter<br />

832. Campto Irinotecanum conc. for sol.<br />

for inf.<br />

833. Campto Irinotecanum conc. for sol.<br />

for inf.<br />

834. Cancidas Caspofunginum powder for<br />

conc. for sol.<br />

for inf.<br />

835. Cancidas Caspofunginum powder for<br />

conc. for sol.<br />

for inf.<br />

836. Cancidas Caspofunginum powder for sol.<br />

for inf.<br />

40mg/2ml vial N1 Rhone-Poulenc<br />

Rorer<br />

100mg/5ml vials N1 Rhone-Poulenc<br />

Rorer<br />

50mg/vial N1 MSD<br />

70mg/vial N1 MSD<br />

50mg/vial N1 MSD<br />

837. Canesten cream Clotrimazolum cream 200mg/20g 20g Egis<br />

838. Canesten solution Clotrimazolum sol. 200mg/20ml 20ml Egis<br />

839. Canesten vaginal tab. Clotrimazolum vaginal tab. 100mg<br />

N6<br />

840. Canifug — Creme Clotrimazolum cream 1g/100g 20g Wolff<br />

841. Canifug — Lösung Clotrimazolum solution 8,5mg/ml 30ml; 50ml Wolff<br />

842. Canifug Cremolum 200 Clotrimazolum pessary 200mg N3 Wolff<br />

843. Canifug Cremolum 200 Kombi Clotrimazolum pessary+cream 200mg N3; 2g/100g 20g Wolff<br />

844. Canifug-Cremolum 100 Clotrimazolum vaginal supp. 100mg N6 Wolff<br />

845. Canifug-Vaginalcreme Clotrimazolum vaginal cream 1g/100g 35g Wolff<br />

846. Capadol Cyclamen D3+ Cimicifuga<br />

D3+ Gelsemium D3+ Iris D2+<br />

Sanguinaria Ø (Ethanolum<br />

2,26g/10g)<br />

oral sol. 1g+1g+1g+ 1g+1g/10g<br />

(10,9ml) 30ml;50ml<br />

847. Capivit A + E forte Retinolum+ Tocopherolum caps. 2500UI+ 150mg N30 Glaxo Wellcome<br />

848. Capivit A + E mite Retinolum+ Tocopherolum caps. 2500UI+ 50mg N30 Glaxo Wellcome<br />

849. Capivit E<br />

100 mg<br />

850. Capozide Captoprilum+<br />

Hydrochlorothiazidum<br />

Tocopherolum caps. 100mg<br />

N30<br />

851. Capsicam Dimethylis sulfoxidum +<br />

Camphora racemica+<br />

Terpentini oleum + Benzylis<br />

nicotinas+ Vanillylnonamidum<br />

Egis<br />

DHU<br />

Glaxo Wellcome<br />

tab. 50mg+25mg N30 Squib Industria<br />

Farmaceutica<br />

ointment 50mg+30mg+ 30mg+20mg+<br />

2mg/g 50g<br />

852. Captogamma 12,5 Captoprilum scored tab. 12,5mg<br />

N50<br />

853. Captogamma 25 Captoprilum scored tab. 25mg<br />

N50<br />

854. Captogamma 50 Captoprilum scored tab. 50mg<br />

N50<br />

Tallinna<br />

Farmaatsiatehase<br />

Worwag Pharma<br />

Worwag Pharma<br />

Worwag Pharma


EN<br />

154 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

855. Captopril Captoprilum tab. 12,5mg N30 Jelfa<br />

856. Captopril Captoprilum tab. 25mg N30 Jelfa<br />

857. Captopril Captoprilum tab. 50mg N30 Jelfa<br />

858. Captopril Captoprilum tab. 50mg N20; N60 Polpharma<br />

859. Captopril Captoprilum tab. 25mg N20; N60 Polpharma<br />

860. Captopril Captoprilum tab. 12,5mg N20; N60 Polpharma<br />

861. Captopril Alpharma Tablets<br />

12,5 mg<br />

862. Captopril Alpharma Tablets<br />

25 mg<br />

863. Captopril Alpharma Tablets<br />

50 mg<br />

864. Captopril-EGIS<br />

12,5 mg<br />

Captoprilum tab. 12,5mg N30 Alpharma<br />

Captoprilum tab. 25mg N30 Alpharma<br />

Captoprilum tab. 50mg N30 Alpharma<br />

Captoprilum tab. 12,5mg N30 Egis<br />

865. Captopril-EGIS 50 mg Captoprilum tab. 50mg N20 Egis<br />

866. Captopril-EGIS 25 mg Captoprilum tab. 25mg N30 Egis<br />

867. Carbalex 200mg Carbamazepinum tablets 200mg N50 Gerot Pharmaceutica<br />

868. Carbalex 400mg Carbamazepinum tablets 400mg N50 Gerot Pharmaceutica<br />

869. Carbalex retard<br />

300 mg<br />

870. Carbalex retard<br />

600 mg<br />

Carbamazepinum tab. 300mg N50 Gerot Pharmazeutika<br />

Carbamazepinum tab. 600mg N50 Gerot Pharmazeutika<br />

871. Carbamazepin Carbamazepinum tablets 200mg N50 Balkanpharma-<br />

Dupnitza<br />

872. Carbatol-200 Carbamazepinum tab. 200mg N100 Torrent<br />

873. Carbenicillin Carbenicillinum powder for inj. 1g<br />

N1 vial<br />

874. Carbo medicinalis Activated charcoal tab. 300mg<br />

N20<br />

Polfa Tarchomin<br />

ICN Polfa Rzeszow<br />

875. Carboplatin Carboplatinum sol.for inj. 10mg/ml 5ml Abic for Teva<br />

876. Carboplatin Carboplatinum sol. for inj. 10mg/ml<br />

5ml vials N1<br />

877. Carboplatin Carboplatinum sol. for inj. 10mg/ml<br />

15ml vials N1<br />

878. Carboplatin Carboplatinum sol. for inj. 10mg/ml<br />

45ml vials N1<br />

879. Carboplatin ‘Ebewe’<br />

150 mg<br />

880. Carboplatin ‘Ebewe’<br />

50 mg<br />

Carboplatinum concentrate for<br />

sol. for inf.<br />

Carboplatinum concentrate for<br />

sol. for inf.<br />

881. Carbosan Carbenoxolonum gel 20mg/g<br />

5g<br />

882. Cardace<br />

2,5 mg<br />

Ramiprilum tab. 2,5mg<br />

N28; N98<br />

10mg/ml 15ml vial N1 Ebewe<br />

10mg/ml 5ml vial N1 Ebewe<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Rowa<br />

Aventis Pharma


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 155<br />

No. Commercial name General name<br />

883. Cardace<br />

10 mg<br />

884. Cardace<br />

5mg<br />

885. Cardiket<br />

retard 20<br />

886. Cardiket<br />

retard 40<br />

887. Cardiket<br />

retard 60<br />

888. Cardil<br />

120 mg<br />

Pharmaceutical<br />

form<br />

Ramiprilum tab. 10mg<br />

N28<br />

Ramiprilum tab. 5mg<br />

N28; N98<br />

Isosorbidi dinitras sustainedrelease<br />

tab.<br />

Isosorbidi dinitras sustainedrelease<br />

tab.<br />

Isosorbidi dinitras sustainedrelease<br />

tab.<br />

Diltiazemum controlledrelease<br />

tab.<br />

20mg<br />

N20; N50<br />

40mg<br />

N20; N50<br />

60mg<br />

N20; N50<br />

889. Cardil 60 mg Diltiazemum film-coated tab. 60mg<br />

N30; N100<br />

890. Cardiol C Tinct.Convallariae+<br />

Tinct.Valerianae+<br />

Tinct.Crataegi+Extr.Colae fl.+<br />

Coffeinum+ Ethanolum<br />

891. Cardioplegic Solution<br />

St.Thomas for Perfusion<br />

892. Cardiosper-mum-Salbe<br />

Cosmochema<br />

Natrii chloridum+<br />

Kalii chloridum+<br />

Magnesii chloridum+<br />

Calcii chloridum<br />

Cardiospermum halicacabum<br />

O (Ethanolum 14,5vol.-%)<br />

893. Cardioxan Dexrazoxanum powder for sol.<br />

for inf.<br />

894. Cardiplant Extr.Crataegi ex folia cum<br />

flores spir.sicc.<br />

895. Cardonit retard 40 mg Isosorbidi dinitras prolongedrelease<br />

tab.<br />

896. Cardonit retard 60mg Isosorbidi dinitras prolongedrelease<br />

tab.<br />

897. Cardonit retard 80mg Isosorbidi dinitras prolongedrelease<br />

tab.<br />

Strength Manufacturer<br />

120mg N30; N100 Orion<br />

drops 27g+20g+ 20g+14g+ 72mg+<br />

ad 100g 40ml<br />

sol. for perfus. 6,43g+1,193g+3,253g+<br />

0,1758g/1000ml 500ml;<br />

1000ml<br />

Aventis Pharma<br />

Aventis Pharma<br />

Schwarz Pharma<br />

Schwarz Pharma<br />

Schwarz Pharma<br />

Orion<br />

Herbapol Wroclaw<br />

Ilsanta<br />

ointment 10g/100g 50g Heel<br />

500mg N1 Chiron<br />

film-coated tab. 80mg N50;N100 Dr.Willmar Schwabe<br />

40mg N30 Polfa Warsaw<br />

60mg N30 Polfa Warsaw<br />

80mg N30 Polfa Warsaw<br />

898. Cardura Doxazosinum tab. 1mg N30 Pfizer<br />

899. Cardura Doxazosinum tab. 4mg N30 Pfizer<br />

900. Cardura Doxazosinum tab. 2mg N30 Pfizer<br />

901. Cardura Doxazosinum tab. 8mg N30 Pfizer<br />

902. Cardura XL Doxazosinum modified-release<br />

tab.<br />

903. Cardura XL Doxazosinum modified-release<br />

tab.<br />

904. Carminativum Babynos lašai<br />

nuo viduriu˛ pūtimo<br />

Foeniculi amari fructus<br />

extractum fluidum (1:1)+<br />

Coriandri fructus extractum<br />

fluidum (1:1)+ Matricaria flos<br />

extractum fluidum (1:1)<br />

8mg N28 Pfizer/Mack<br />

4mg N28 Pfizer/Mack<br />

drops 320mg+ 200mg+ 200mg/g<br />

(Ethanolum 36 vol.-%) 30ml<br />

905. Carsil Silymarinum film-coated tab. 35mg<br />

N80<br />

Dentinox<br />

Sopharma PLC


EN<br />

156 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

906. Casodex Bicalutamidum film-coated tab. 50mg<br />

N28<br />

907. Casodex<br />

150 mg<br />

Bicalutamidum film-coated tab. 150mg<br />

N28<br />

908. Cassadan 0,25 Alprazolamum tab. 0,25mg<br />

N10; N20; N50<br />

909. Cassadan 0,5 Alprazolamum tab. 0,5mg<br />

N10; N20; N50<br />

Strength Manufacturer<br />

910. Castor oil Ol. Ricini caps. 500mg N10 Biogal<br />

911. Cataflam Diclofenacum kalicum coated tab. 25mg<br />

N20<br />

912. Cataflam Diclofenacum kalicum coated tab. 50mg<br />

N20<br />

913. Cathejell Lidocain Lidocainum+ Chlorhexidinum catheter<br />

lubricant gel<br />

914. Caustinerf Arsenical Ephedrinum + Lidocainum+<br />

Arsenious trioxide<br />

915. Caustinerf be arseno Lidocainum+<br />

Paraformaldehydum<br />

paste for dental<br />

use<br />

paste for dental<br />

use<br />

916. Caverject Alprostadilum powder and<br />

solvent for sol.<br />

for inj.<br />

917. Caverject Alprostadilum powder and<br />

solvent for sol.<br />

for inj.<br />

2g+50mg/<br />

100g 12,5g accordion syringe<br />

(tube)<br />

1%+30%+<br />

30% 6,5g<br />

AstraZeneca<br />

AstraZeneca<br />

AWD<br />

AWD<br />

Novartis Pharma<br />

Novartis Pharma<br />

Montavit<br />

Septodont<br />

36%+47% 4,5g Septodont<br />

10µg solvent: Benzyl alcohol<br />

9mg/ml<br />

20µg solvent: Benzyl alcohol<br />

9mg/ml<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

918. Cavinton Vinpocetinum sol. for inj. 10mg/2ml amp. N10 Gedeon Richter<br />

919. Cavinton Vinpocetinum tab. 5mg<br />

N50<br />

920. Cavinton forte Vinpocetinum tab. 10mg<br />

N30; N90<br />

921. Cec 500 Cefaclorum tab. 500mg N10; N20 Hexal<br />

922. Ceclor Cefaclorum drops 50mg/ml 20ml Eli Lilly<br />

923. Ceclor Cefaclorum gran. for oral<br />

susp.<br />

924. Ceclor Cefaclorum gran. for oral<br />

susp.<br />

375mg/5ml 100ml Eli Lilly<br />

187mg/5ml 100ml Eli Lilly<br />

925. Ceclor Cefaclorum caps. 250mg N15 Eli Lilly<br />

926. Ceclor Cefaclorum gran. for oral<br />

susp.<br />

125mg/5ml 60ml; 100ml Eli Lilly<br />

927. Ceclor Cefaclorum caps. 500mg N15 Eli Lilly<br />

928. Ceclor Cefaclorum gran. for oral<br />

susp.<br />

929. Ceclor MR 375 mg Cefaclorum extended-release<br />

tab.<br />

250mg/5ml 100ml Eli Lilly<br />

375mg<br />

N10<br />

Gedeon Richter<br />

Gedeon Richter<br />

Eli Lilly


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 157<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

930. Ceclor MR 750 mg Cefaclorum extended-release<br />

tab.<br />

750mg<br />

N10<br />

931. Cefagil Turnera diffusa Ø tab. 25mg<br />

N100; N200<br />

932. Cefakliman mono Cimicifugae e rhizoma<br />

extractum siccum (4:1)<br />

933. Cefaleksins Cefalexinum caps. 250mg<br />

N30; N500<br />

Strength Manufacturer<br />

Eli Lilly<br />

Ursapharm<br />

caps. 5mg N50 Ursapharm<br />

Grindeks<br />

934. Cefaleksins Cefalexinum caps. 500mg N20 Grindeks<br />

935. Cefalexin 250mg Cefalexinum caps., hard 250mg N20 Balkanpharma-<br />

Razgrad<br />

936. Cefalexin 500mg Cefalexinum caps., hard 500mg N20 Balkanpharma-<br />

Razgrad<br />

937. Cefamadar Madar trit.D4 tab. 250mg N100;N200 Ursapharm<br />

938. Cefamandole 1g I.M./I.V. Cefamandolum powder for sol.<br />

for inj.<br />

939. Cefamezin Cefazolinum powder for sol.<br />

for inj.<br />

940. Cefavora Ginkgo biloba+ Viscum<br />

album+ Crataegus<br />

941. Cefaxone Ceftriaxonum powder for sol.<br />

for inj.<br />

942. Cefaxone Ceftriaxonum powder for sol.<br />

for inj.<br />

943. Cefazolin Cefazolinum powder for sol.<br />

for inj.<br />

944. Cefazolin Cefazolinum powder for sol.<br />

for inj.<br />

945. Cefazolin Cefazolinum powder for sol.<br />

for inj.<br />

946. Cefazolin ‘Biochemie’ 1g vials Cefazolinum powder for sol.<br />

for inj.<br />

947. Cefazolin Nycomed Cefazolinum; Lidocaini<br />

hydrochloridum (solvent)<br />

948. Cefazolin Nycomed Cefazolinum; Lidocaini<br />

hydrochloridum (solvent)<br />

1g/vial N10 Balkanpharma-<br />

Razgrad<br />

1g/vial N1 KRKA<br />

drops 100ml Cefak KG<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

0,5g N1 Lupin<br />

1g N1 Lupin<br />

1000mg N1 Teva<br />

500mg/vial N10 Balkanpharma-<br />

Razgrad<br />

1g/vial N10 Balkanpharma-<br />

Razgrad<br />

1g/vial N50 Biochemie<br />

500mg (15mg/3ml) N1 Crosara<br />

1000mg (25mg/4ml) N1 Crosara<br />

949. Ceff Cefalexinum caps. 250mg N100 Lupin<br />

950. CEFF caps. 500mg Cefalexinum caps. 500mg N20 Lupin/ Sanitas<br />

951. Cefobid 1 g Cefoperazonum powder for sol.<br />

for inj.<br />

952. Cefobid 2 g Cefoperazonum powder for sol.<br />

for inj.<br />

1g/vial<br />

N1<br />

2g/vial<br />

N1<br />

Pfizer<br />

Pfizer


EN<br />

158 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

953. Cefotaxime Cefotaximum powder for sol.<br />

for inj.<br />

954. Cefotaxime 1g Cefotaximum powder for sol.<br />

for inj.<br />

955. Cefotaxime Biochemie<br />

1000 mg<br />

Cefotaximum powder for sol.<br />

for inj. or inf.<br />

956. Ceftriaksons-Grindeks Ceftriaxonum powder for<br />

solution for<br />

injection<br />

957. Ceftriaxon 1000-SL Ceftriaxonum powder for sol.<br />

for inj.<br />

958. Ceftriaxon 2000-SL Ceftriaxonum powder for sol.<br />

for inj.<br />

959. Ceftriaxone Biochemie<br />

1000 mg<br />

Ceftriaxonum powder for sol.<br />

for inj. or inf.<br />

960. Cefuroxim ‘Biochemie’ Cefuroximum powder for sol.<br />

for inj.<br />

961. Cefuroxim ‘Biochemie’ Cefuroximum powder for sol./<br />

susp. for inj.<br />

962. Cefuroxim ‘Biochemie’<br />

1500 mg infusion-bottles<br />

Cefuroximum powder for sol.<br />

for inf.<br />

Strength Manufacturer<br />

1g/vial N1 Lek<br />

1g N100 Labesfal-Laboratorios<br />

Almiro<br />

1000mg vials N1; N5; N10;<br />

N25; N50; N100<br />

Hikma<br />

1g N1;N10 Hanmi Pharm.Co.,<br />

Ltd /Latvian Public<br />

Join Stock Company<br />

Grindeks<br />

1g/bottle N5 Slovakofarma<br />

2g/bottle N5 Slovakofarma<br />

1 000mg vials N1; N5; N10;<br />

N25; N50; N100<br />

Hikma<br />

1500mg N1; N5; N25 Biochemie<br />

750mg N1; N5; N25 Biochemie<br />

1500mg N1; N5 Biochemie<br />

963. Cefzil Cefprozilum tab. 500mg N10 Bristol-Myers Squibb<br />

964. Cefzil Cefprozilum tab. 250mg N10 Bristol-Myers Squibb<br />

965. Cefzil Cefprozilum powder for oral<br />

susp.<br />

966. Cefzil Cefprozilum powder for oral<br />

susp.<br />

967. Celebrex<br />

100 mg<br />

968. Celebrex<br />

200 mg<br />

125mg/5ml 60ml Bristol-Myers Squibb<br />

250mg/5ml 60ml Bristol-Myers Squibb<br />

Celecoxibum caps., hard 100mg N10; N20; N30 Mack<br />

Celecoxibum caps., hard 200mg N10; N20; N30 Mack<br />

969. Celestoderm-V Betamethasonum oint-ment 1mg/g 30g Schering-Plough<br />

970. Celestoderm-V Betamethasonum cream 1mg/g 30g Schering-Plough<br />

971. Celiprol 100 Celiprololi hydrochloridum film-coated tab. 100mg N30;N100 Lečiva<br />

972. Celiprol 200 Celiprololi hydrochloridum film-coated tab. 200mg N30;N100 Lečiva<br />

973. CellCept<br />

250 mg<br />

974. CellCept<br />

500 mg<br />

975. CellCept<br />

500 mg<br />

Mycophenolate mofetil caps. 250mg N100; N300 Roche<br />

Mycophenolate mofetil powder for<br />

concentrate for<br />

sol. for inf.<br />

Mycophenolate mofetil tab. 500mg<br />

N50; N150<br />

500mg/vial N4 Parke-Davis Sterile<br />

Roche


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 159<br />

No. Commercial name General name<br />

976. Cellimun (Cellimun) Retinolum+<br />

Thiaminum+Riboflavinum+<br />

Nicotinamidum+Acidum<br />

nicotinicum+Calcii<br />

pantothenas+ Pyridoxinum+<br />

Cyanocobalaminum+Acidum<br />

ascorbicum+Grapeskin<br />

extract+Tocopherolum+<br />

Lycopene+Lutein ester+<br />

Biotinum+Acidum folicum+<br />

Ubichinone Q10+ Selenium +<br />

Zincum+Soya lecithinum<br />

Pharmaceutical<br />

form<br />

caps.,<br />

soft<br />

Strength Manufacturer<br />

400µg+2,8mg+3,2mg+<br />

18,92mg+<br />

1,98mg+<br />

12mg+4mg+<br />

2µg+120mg+70mg+ 40mg+<br />

6mg+1,5mg+ 2,5mg+0,3mg+<br />

400µg+<br />

150µg+20µg+15mg+ 60mg<br />

N40<br />

Swiss Caps<br />

977. Čemeryčiu˛ vanduo Aqua Veratri sol. 40ml Vilniaus f.f.<br />

978. Cephalexin — Teva Cefalexinum powder for oral<br />

susp.<br />

250mg/5ml 60ml Teva<br />

979. Cephalexin — Teva Cefalexinum caps. 250mg N12 Teva<br />

980. Cephalexin — Teva Cefalexinum caps. 500mg N12 Teva<br />

981. Cephyl Acidum acetyl salicylicum+<br />

Coffeinum+Belladonnae<br />

tinctura+Iris versicolor tinctura<br />

+Nux vomicae tinctura+<br />

Spigeliae anthelmiae tinctura +<br />

Gelsemium sempervirens<br />

tinctura<br />

982. Ceporex Cefalexinum granules for<br />

syrup<br />

983. Ceporex Cefalexinum granules for<br />

syrup<br />

tab. 330mg+<br />

36,6mg+<br />

0,004µg+<br />

0,004µg+<br />

0,004µg+<br />

0,004µg+<br />

0,004µg<br />

N20; N60<br />

Boiron<br />

250mg/5ml 60ml Glaxo<br />

125mg/5ml 60ml;100ml Glaxo<br />

984. Ceporex Cefalexinum caps. 500mg N100 Glaxo<br />

985. Ceporex Cefalexinum caps. 250mg N100 Glaxo<br />

986. Cerazette Desogestrelum coated tab. 0,075mg N28; N3×28 Organon<br />

987. Cerebrolysin Cerebrolysinum sol. for inf. 215,2mg/ml 10ml amp.; 20ml,<br />

30ml, 50ml vials<br />

988. Cerebrolysin Cerebrolysinum concentrate for<br />

sol. for inj./inf.<br />

989. Ceretec (Kit for the preparation<br />

of Technetium [99mTc]<br />

Exametazime)<br />

Exametazime powder for i.v.<br />

inj.<br />

990. Cerezyme 200 U Imiglucerasum powder for<br />

sol.for inf.<br />

991. Cerezyme 400 U Imiglucerasum powder for<br />

sol.for inf.<br />

Ebewe<br />

1076mg/5ml amp. N5 Ebewe<br />

0,5mg/vial (single dose) N2;N5 Nycomed Amersham<br />

200U/vial N1 Genzyme<br />

400U/vial N1 Genzyme<br />

992. Cerucal Metoclopramidum sol. for inj. 5mg/ml 2ml amp. N10 AWD<br />

993. Cerucal Metoclopramidum tab. 10mg<br />

N50; N100<br />

994. Cesradyston 200 Extr. herb. Hyperici sicc. caps. 200mg<br />

N40<br />

995. Cetebe Acidum ascorbicum slow-release<br />

caps.<br />

AWD<br />

Redel<br />

500mg N30 Fink


EN<br />

160 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

996. Cetirizin Hexal Cetirizinum film-coated<br />

tablets<br />

997. Cetirizin Hexal express Cetirizinum film-coated<br />

tablets<br />

Strength Manufacturer<br />

10mg N30 Salutas Pharma<br />

10mg N10 Salutas Pharma<br />

998. Cetirizine Cetirizinum tab. 10mg N10; N30; N100 Delta<br />

999. Cetirizine Alpharma tablets<br />

10mg<br />

Cetirizinum film-coated<br />

tablets<br />

10mg N10;N30 Alpharma Limited<br />

1000. Cetirizin-SL Cetirizinum film-coated tab. 10mg N10; N20; N30; N50 Slovakofarma<br />

1001. Cetrotide<br />

3mg<br />

Cetrorelixum powder and<br />

solvent for sol.<br />

for inj.<br />

1002. Cetrotide 0,25 mg Cetrorelixum powder and<br />

solvent for sol.<br />

for inj.<br />

1003. Cezolin Cefazolinum powder for sol.<br />

for inj.<br />

1004. Cezolin Cefazolinum powder for sol.<br />

for inj.<br />

3mg/vial and 3ml of solvent in<br />

pre-filled syringe N1<br />

0,25mg/vial and 1 ml of<br />

solvent in pre-filled syringe<br />

N1; N7<br />

1g N1 Lupin<br />

0,5g N1 Lupin<br />

Asta Medica<br />

Asta Medica<br />

1005. Chamo fix Chamomillae flos herbal tea 1,5g/sachets N20 Herba Humana<br />

1006. Chamomilla Matricariae extractum fluidum sol. 25ml (Ethanolum<br />

37 % (V/V))<br />

1007. Chamomilla Matricariae extractum fluidum sol. 100ml (Ethanolum<br />

37 % (V/V))<br />

1008. Charlieu Anti-Lice Shampoo Permethrinum+ Piperonyli<br />

butoxidum<br />

1009. Chelidonium-Homaccord Chelidonium majus D10+<br />

Celidonium majus D30+<br />

Chelidonium majus D200+<br />

Atropa belladonna D10+<br />

Atropa belladonna D30+<br />

Atropa belladonna D200+<br />

Atropa belladonna D1000+Fel<br />

tauri D10+Fel tauri D30+Fel<br />

tauri D200 Alcohol 35%<br />

shampoo 200mg+800mg/100g 150ml;<br />

300ml<br />

drops 0,6g+0,6g+ 0,6g+0,3g+ 0,3g+<br />

0,3g+ 0,3g+0,1g+ 0,1g+<br />

0,1g/100g 30ml; 100ml<br />

1010. Chemacin Amikacini sulfas sol.for.inj. 500mg/2ml amp.<br />

N1<br />

IVAX-CR<br />

IVAX-CR<br />

Mayoly Spindler<br />

Laboratories<br />

Heel<br />

Laboratorio<br />

Farmaceutico<br />

1011. Chemacin Amikacini sulfas sol. for inj. 1 000mg/4ml amp. N1 Laboratorio<br />

Farmaceutico<br />

1012. Children's Motrin Drops Ibuprofenum oral drops,<br />

susp.<br />

1013. Children's Motrin Oral<br />

Suspension<br />

1014. Children's Tylenol Cherry<br />

Flavour<br />

1015. Children's Tylenol Cold Plus<br />

Cough Liquid Cherry Flavour<br />

40mg/ml<br />

15ml<br />

McNeil/ Grindeks<br />

Ibuprofenum oral susp. 100mg/5ml 60ml; 120ml McNeil/ Grindeks<br />

Paracetamolum elixir 160mg/5ml 30ml McNeil/ Grindex<br />

Paracetamolum+<br />

Pseudoephedrinum+<br />

Dextromethorphanum+<br />

Chlorphenaminum<br />

1016. Chinoksyzol 8-hydroxychinoline sulfate +<br />

Acidum boricum<br />

liquid 160mg+15mg+5mg+1mg/5ml<br />

30ml;120ml<br />

tab. 200 mg +<br />

40 mg N10<br />

McNeil/ Grindex<br />

Liuks


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 161<br />

No. Commercial name General name<br />

1017. Chloramphenicol PW<br />

Ohrentropfen<br />

1018. Chloramphenicol solubile inj.<br />

ICN<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

chloramphenicolum sol. 5g/100ml 10ml Wernigerode<br />

chloramphenicolum powder for sol.<br />

for inj.<br />

1019. Chlorchinaldin Chlorquinaldolum chewable tab. 2mg<br />

N20<br />

1g/vial N1 ICN Czech Republic<br />

1020. Chloretyl Ethylis chloridum sol. 20ml;30ml amp. Farmak<br />

1021. Chlorheksidino 0,05 % 500ml<br />

tirpalas irigacijoms<br />

Chlorhexidini diacetas+ Natrii<br />

acetas<br />

irrigation sol. 0,5g+ 21g/500ml 500ml Ilsanta<br />

1022. Chlorhexidine 0,05 % Chlorhexidinum irrigation sol. 0,5mg/ml 1000ml Unimedic<br />

1023. Chlorhexidine 0,05% 500ml<br />

Irrigation (Chlorheksidino<br />

0,05% 500ml tirpalas<br />

irrigacijoms)<br />

1024. Chlorhexidine Gluconate<br />

Mouthwash Original Flavour<br />

1025. Chlorhexidine Gluconate<br />

Mouthwash Peppermint<br />

Flavour<br />

Chlorhexidinum + Natrii acetas irrigation<br />

solution<br />

Chlorhexidinum oromuco-sal<br />

sol.<br />

Chlorhexidinum+ Ethanolum<br />

96%<br />

oromuco-sal<br />

sol.<br />

ICN Polfa Rzeszow<br />

0,5g+21g/l, 500ml Lietuvos, Islandijos ir<br />

Švedijos i˛mone˙ UAB<br />

‘Ilsanta’<br />

0,2% w/v+<br />

5% w/w 300ml<br />

0,2% w/v+<br />

5% w/w 300ml<br />

Adams Healthcare<br />

Adams Healthcare<br />

1026. Cholinex Cholini salicylas lozenges 150mg N16 GlaxoSmithKline<br />

Pharmaceuticals<br />

1027. Cholitol Tinct.Belladonnae+<br />

Tinct.Chelidonii+<br />

Tinct.Menthae piperitae+Tinct.<br />

Valerianae+Tinct.Curcumae+<br />

Succ.Taraxaci+ Ethanolum<br />

60%<br />

1028. Chorioninis gonadotropinas<br />

injekcijoms 1000 TV<br />

1029. Chorioninis gonadotropinas<br />

injekcijoms 2000 TV<br />

1030. Chorioninis gonadotropinas<br />

injekcijoms 500 TV<br />

Gonadotrophinum<br />

chorionicum<br />

Gonadotrophinum<br />

chorionicum<br />

Gonadotrophinum<br />

chorionicum<br />

1031. Chronocard forte Extr.Crataegi ex folia cum<br />

flores spir.sicc.<br />

1032. Cianokobalamino (Vitamino<br />

B12)<br />

200 µg tirpalas injekcijoms<br />

1033. Cianokobalamino (Vitamino<br />

B12) 500 µg tirpalas<br />

injekcijoms<br />

1034. Cianokobalamino (Vitamino<br />

B12) 1000 µg tirpalas<br />

injekcijoms<br />

1035. Cianokobalamino (Vitamino<br />

B12) 200 µg tirpalas<br />

injekcijoms<br />

liquid 7g+11g+ 12g+15g+ 30g+25g/<br />

100g 35g<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

drag. 100mg<br />

N40; N100<br />

Herbapol Cracow<br />

1000TV (1ml amp.) N2; N5 Endokrininiai<br />

preparatai<br />

2000TV (1ml amp.) N2; N5 Endokrininiai<br />

preparatai<br />

500TV (1ml amp.) N1; N5 Endokrininiai<br />

preparatai<br />

Redel<br />

Cyanocobalaminum sol. for inj. 200µg/ml 1ml amp. N10 Endokrininiai<br />

preparatai<br />

Cyanocobalaminum sol. for inj. 500µg/ml 1ml amp. N10 Endokrininiai<br />

preparatai<br />

Cyanocobalaminum sol. for inj. 1000µg/ml 1ml amp. N10 Sanitas<br />

Cyanocobalaminum sol. for inj. 200µg/ml amp. N10 Bakteriniai<br />

preparatai


EN<br />

162 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

1036. Cianokobalamino (Vitamino<br />

B12) 200 µg tirpalas<br />

injekcijoms<br />

1037. Cianokobalamino (Vitamino<br />

B12) 500 µg tirpalas<br />

injekcijoms<br />

1038. Cianokobalamino (Vitamino<br />

B12) 500 µg tirpalas<br />

injekcijoms<br />

1039. Cicaderma Calendula officinalis+<br />

Hypericum perforatum+<br />

Achillea millefolium+Ledum<br />

palustra MT+Anemone<br />

pulsatilla MT<br />

Pharmaceutical<br />

form<br />

Cyanocobalaminum sol. for inj. 200µg/ml<br />

1ml amp. N10<br />

Strength Manufacturer<br />

Sanitas<br />

Cyanocobalaminum sol. for inj. 500µg/ml amp. N10 Bakteriniai<br />

preparatai<br />

Cyanocobalaminum sol. for inj. 500µg/ml<br />

1ml amp. N10<br />

ointment 200mg+100mg+100mg+<br />

15mg+15mg/g 30g<br />

1040. Cicloral 100mg capsules Cyclosporinum A capsules 100mg N50;N100 Salutas Pharma<br />

GmbH<br />

1041. Cicloral 25mg capsules Cyclosporinum A capsules 25mg N50;N100 Salutas Pharma<br />

GmbH<br />

1042. Cicloral 50mg capsules Cyclosporinum A capsules 50mg N50;N100 Salutas Pharma<br />

GmbH<br />

1043. Cicloral oral solution Ciclosporin oral solution 100mg/ml 50ml bottle Salutas Pharma<br />

GmbH<br />

1044. Cifloxinal Ciprofloxacinum coated tab. 250mg N10;N20 Pro. Med. CS Praha<br />

1045. Cifran 250 mg Ciprofloxacinum film-coated tab. 250mg<br />

N10<br />

1046. Cifran 500 mg Ciprofloxacinum film-coated tab. 500mg<br />

N10<br />

1047. Cikloferon Cycloferone enterosoluble<br />

tab.<br />

1048. Cikloferono linimentas<br />

5%<br />

1049. Cilest Norgestimatum+<br />

Ethinylestradiolum<br />

150mg<br />

N10<br />

Cycloferone linimentum 50mg/ml<br />

5ml N10<br />

tab. 0,25mg+ 0,035mg<br />

N21; N63<br />

Sanitas<br />

Boiron<br />

Ranbaxy<br />

Ranbaxy<br />

1050. Ciloxan Ciprofloxacinum eye drops 3mg/ml 5ml Alcon-Couvreur<br />

1051. Cimetidin Cimetidinum film-coated tab. 200mg<br />

N100<br />

1052. Cimetidin 200 Stada Cimetidinum tab. 200mg<br />

N100<br />

1053. Cimetidin 400 Stada Cimetidinum tab. 400mg N20;N50;<br />

N100<br />

1054. Cimetidin 800 Stada Cimetidinum tab. 800mg<br />

N20; N50<br />

1055. Cimetidino 200 tablete˙s Cimetidinum tab. 200 mg N20; N30; N50; N60;<br />

N100<br />

1056. Cimetidino 400 tablete˙s Cimetidinum tab. 400 mg N20; N30; N50; N60;<br />

N100<br />

Polisan<br />

Polisan<br />

Cilag<br />

Balkanpharma-<br />

Dupnitza<br />

Stada<br />

Stada<br />

Stada<br />

Liuks<br />

Liuks


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 163<br />

No. Commercial name General name<br />

1057. Cimicifuga-Homaccord Cimicifuga racemosa D2+<br />

Cimicifuga racemosa D10+<br />

Cimicifuga racemosa D30+<br />

Cimicifuga racemosa D200+<br />

Strontium carbonicum D8+<br />

Strontium carbonicum D30+<br />

Strontium carbonicum D200;<br />

(Ethanolum 35%)<br />

1058. Cinarizino<br />

25 mg tablete˙s<br />

1059. Cinfatos Dextromethorphani<br />

hydrobromidum<br />

1060. Cinfatos Complex Paracetamolum+<br />

Dextromethorphani<br />

hydrobromidum+<br />

Pseudoephedrini<br />

hydrochloridum<br />

1061. Cinfatos Expectorant Dextromethorphani<br />

hydrobromidum+<br />

Guaifenesinum<br />

Pharmaceutical<br />

form<br />

drops 0,8g+0,8g+ 0,8g+0,8g+ 0,2g+<br />

0,2g+ 0,2g 30ml;100ml<br />

Strength Manufacturer<br />

Cinnarizinum tab. 25 mg N50 Liuks<br />

Heel<br />

coated tab. 10mg N20 Cinfa<br />

oral susp. 250mg+ 10mg+ 30mg/5ml<br />

125ml<br />

Cinfa<br />

syrup 10mg+ 100mg/5ml 125ml Cinfa<br />

1062. Cinko oksido 10 % tepalas Zinci oxidum ointment 10g/100g 25g; 40g; 90g; 200g Sanitas<br />

1063. Cinko pasta Zinci oxidum paste 250mg/g<br />

30g; 50g<br />

1064. Cinko sulfato 0,25 % ir boro<br />

rūgšties 2 % tirpalas-akiu˛ lašai<br />

1065. Cinnabsin Cinnabaris D3+ Hydrastis D3+<br />

Kalium bichromatum D3+<br />

Echinacea angustifolia D1+<br />

Barium chloratum D3<br />

Zinci sulfas+ Acidum boricum eye drops sol. 2,5mg+<br />

20mg/ml<br />

1,5ml ampule˙s-lašintuvai<br />

N2; N4; N10<br />

tab. 25mg+25mg+ 25mg+25mg+<br />

25mg<br />

N60<br />

KMU vaistine˙<br />

Endokrininiai<br />

preparatai<br />

1066. Cinnabsin N compos. tablets N100 Deutsche<br />

Homöopathie Union<br />

GmbH & Co. KG<br />

1067. Cinnarisine Cinnarizinum tab. 25mg<br />

N50<br />

DHU<br />

Polfa Warsaw<br />

1068. Cinnarizin Cinnarizinum tab. 25mg N50 Balkanpharma-<br />

Dupnitza<br />

1069. Cinnarizin forte-ratiopharm Cinnarizinum caps. 75mg N50 Scherer<br />

1070. Cinnarizin pharmachim Cinnarizinum tab. 25mg Sopharma<br />

1071. Cinnasan Cinnarizinum caps. 75mg N50 Scherer<br />

1072. Čiobreliu˛ sirupas Extr. Thymi 1:1 syr. 30 sirupus simplex ad 100<br />

100 ml; 150 ml<br />

1073. Ciphin<br />

100 mg/50 ml infusion<br />

solution<br />

1074. Ciphin<br />

200 mg/100 ml infusion<br />

solution<br />

Bakteriniai<br />

preparatai<br />

Ciprofloxacinum sol.for inf. 100mg/ 50ml vial 50ml Slovakofarma<br />

Ciprofloxacinum sol.for inf. 200mg/ 100ml vial 100ml Slovakofarma<br />

1075. Ciphin 250 Ciprofloxacinum coated tab. 250mg N10 Slovakofarma<br />

1076. Ciphin 500 Ciprofloxacinum coated tab. 500mg N10 Slovakofarma


EN<br />

164 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

1077. Ciphin 750 Ciprofloxacinum coated tab. 750mg N10 Slovakofarma<br />

1078. Cipralex Escitalopramum film-coated tab. 20mg<br />

N28<br />

1079. Cipralex Escitalopramum film-coated tab. 5mg<br />

N14; N28<br />

1080. Cipralex Escitalopramum film-coated tab. 15mg<br />

N28<br />

Lundbeck<br />

Lundbeck<br />

Lundbeck<br />

1081. Cipralex Escitalopramum film-coated tab. 10mg N14; N28; N100 Lundbeck<br />

1082. Cipramil Citalopramum tab. 40mg N28;N100 Lundbeck<br />

1083. Cipramil Citalopramum tab. 20mg N14;N28;N100 Lundbeck<br />

1084. Cipramil Citalopramum tab. 10mg N14; N28; N100 Lundbeck<br />

1085. Ciprinol Ciprofloxacinum sol.for inf. 200mg/ 100ml KRKA<br />

1086. Ciprinol Ciprofloxacinum sol.for inf. 100mg/50ml KRKA<br />

1087. Ciprinol Ciprofloxacinum conc. for sol.<br />

for inf.<br />

1088. Ciprinol Ciprofloxacinum film-coated tab. 500mg<br />

N10<br />

1089. Ciprinol Ciprofloxacinum film-coated tab. 250mg<br />

N10<br />

100mg/10ml amp.N5 KRKA<br />

1090. Ciprobid Ciprofloxacinum eye drops 3mg/ml 5ml Cadila<br />

1091. Ciprobid-250 Ciprofloxacinum tab. 250mg N10;100 Cadila<br />

1092. Ciprofloksacins 0,2 % Ciprofloxacinum sol. for inf. 200mg/ 100ml Grindex<br />

1093. Ciprofloksacins 250mg Ciprofloxacinum coated tablets 250mg N10 Intas Pharmaceutical,<br />

Ltd.<br />

1094. Ciprofloksa-cins 500mg Ciprofloxacinum coated tablets 500mg N10 Intas Pharmaceutical,<br />

Ltd.<br />

1095. Ciprofloxacin Ciprofloxacinum film-coated tab 500mg<br />

N10<br />

1096. Ciprofloxacin Ciprofloxacinum film-coated tab 250mg<br />

N20<br />

1097. Cipronex Ciprofloxacinum film coated<br />

tablets<br />

1098. Cipronex Ciprofloxacinum film coated<br />

tablets<br />

KRKA<br />

KRKA<br />

Balkanpharma-<br />

Dupnitza<br />

Balkanpharma-<br />

Dupnitza<br />

500mg N10; N20 Pharmaceutical<br />

Works ‘Polpharma’<br />

S.A.<br />

250mg N10;N20 Pharmaceutical<br />

Works ‘Polpharma’<br />

S.A.<br />

1099. Ciprova Ciprofloxacinum tab. 500mg N20 Lupin<br />

1100. Cirrus Cetirizinum+<br />

Pseudoephedrinum<br />

caps., cont. tab.<br />

and prolongedrelease<br />

gran.<br />

1101. Cisanplat 10 Cisplatinum powder for sol.<br />

fo inj.<br />

1102. Cisanplat 25 Cisplatinum powder for sol.<br />

for inj.<br />

5mg/tab., 597,4mg/g gran.<br />

N14<br />

10mg N10 Dakota<br />

25mg N10 Dakota<br />

UCB Pharma S.p.a.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 165<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1103. Cisanplat 50 Cisplatinum powder for sol.<br />

for inj.<br />

Strength Manufacturer<br />

50mg N5 Dakota<br />

1104. Cisordinol Zuclopenthixolum film-coated tab. 2mg N50; N100 Lundbeck<br />

1105. Cisordinol Zuclopenthixolum film-coated tab. 10mg N50; N100 Lundbeck<br />

1106. Cisordinol Zuclopenthixolum film-coated tab. 25mg N50; N100 Lundbeck<br />

1107. Cisordinol Depot Zuclopenthixolum sol. for inj. 200mg/ml N1; N10 Lundbeck<br />

1108. Cisordinol Depot Zuclopenthixolum sol. for inj. 500mg/ml N5 Lundbeck<br />

1109. Cisordinol-Acutard Zuclopenthixolum sol. for inj. 50mg/ml N10 Lundbeck<br />

1110. Cisplatin Cisplatinum sol. for inj. 1mg/ml 10ml vials N1;N5 Pharmacia & Upjohn<br />

1111. Cisplatin Cisplatinum sol. for inj. 1mg/ml<br />

50ml vials N1<br />

Pharmacia & Upjohn<br />

1112. Cisplatin Cisplatinum sol. for inj. 1mg/ml 100ml vials N1 Pharmacia & Upjohn<br />

1113. Cisplatin ‘Ebewe’ 10 mg Cisplatinum concentrate for<br />

solution for<br />

infusion<br />

1114. Cisplatin ‘Ebewe’<br />

25 mg/50 ml<br />

1115. Cisplatin ‘Ebewe’<br />

50 mg<br />

Cisplatinum conc. for sol.<br />

for inf.<br />

Cisplatinum concentrate for<br />

solution for<br />

infusion<br />

1116. Cisplatin 10mg/20ml Cisplatinum solution for<br />

injection<br />

1117. Cisplatin 25mg/50ml Cisplatinum solution for<br />

injection<br />

1118. Cisplatin 50mg/100ml Cisplatinum solution for<br />

injection<br />

10mg/20ml vial N1 Ebewe<br />

25mg/50ml Ebewe<br />

50mg/ 100ml vial N1 Ebewe<br />

0,5mg/ml 20ml vials N10 Laboratoires Thissen<br />

S.A.<br />

0,5mg/ml 50ml vials N10 Laboratoires Thissen<br />

S.A.<br />

0,5mg/ml 100ml vials N10 Laboratoires Thissen<br />

S.A.<br />

1119. Cisplatin Injection Solution Cisplatinum sol. for inj. 1mg/ml 50ml; 100ml Faulding<br />

Pharmaceuticals<br />

1120. Cisplatin-Teva Cisplatinum sol. for inj. 0,5mg/ml 20ml Teva<br />

1121. Cisplatin-Teva Cisplatinum powder for sol.<br />

for inj. i.v.<br />

10mg 20ml<br />

vial<br />

1122. Cisplatin-Teva Cisplatinum sol. for inj. 0,5mg/ml 50ml Teva<br />

1123. Cisplatin-Teva Cisplatinum powder for sol.<br />

for inj. i.v.<br />

25mg<br />

50ml vial<br />

1124. Cisplatin-Teva Cisplatinum sol. for inj. 0,5mg/ml 100ml Teva<br />

1125. Cisplatin-Teva Cisplatinum powder for sol.<br />

for inj. i.v.<br />

1126. Citalec 10 Citaloprami hydrobromidum film-coated<br />

tablets<br />

1127. Citalec 20 Citaloprami hydrobromidum film-coated<br />

tablets<br />

1128. Citalec 40 Citaloprami hydrobromidum film-coated<br />

tablets<br />

50mg<br />

100ml vial<br />

Teva<br />

Teva<br />

Teva<br />

12,495mg N30 Omega Farma<br />

Iceland, Islandija/<br />

Lečiva a.s., Čekija<br />

24,99mg N30 Omega Farma<br />

Iceland, Islandija/<br />

Lečiva a.s., Čekija<br />

49,88mg N30 Omega Farma<br />

Iceland, Islandija/<br />

Lečiva a.s., Čekija


EN<br />

166 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

1129. Citalopram Alpharma tablets<br />

20mg<br />

Pharmaceutical<br />

form<br />

Citalopramum film-coated<br />

tablet<br />

1130. Citanest Octapressin Prilocainum+Octapressin<br />

sterile stock solution<br />

corresponding to Felypressin<br />

1131. Citarabins Cytarabinum powder for<br />

sol.for inj.<br />

1132. Citramon forte Acidum acetylsalicylicum +<br />

Paracetamolum+ Coffeinum+<br />

Acidum citricum<br />

1133. Citramon P Acidum acetylsalicylicum+<br />

Paracetamolum+ Coffeinum<br />

1134. Citramonas forte Acidum acetylsalycilycum +<br />

Paracetamolum+ Coffeinum<br />

1135. Citramonas L Acidum acetylsalicylicum+<br />

Paracetamolum+ Coffeinum<br />

monohydricum<br />

1136. Citramonas MDF Acidum acetylsalicylicum+<br />

Paracetamolum+<br />

Coffeinum<br />

1137. Citrate of Betaine Beaufour<br />

10 %<br />

1138. Clarinase Pseudoephedrinum+<br />

Loratadinum<br />

Strength Manufacturer<br />

20mg N30 Omega Farma<br />

Iceland<br />

sol. for inj. 30mg/ml+ 0,54µg/dose<br />

cartridge 1,8ml N100<br />

Astra<br />

100mg/amp. N10 Grindeks<br />

tablets 0,32g+0,24g+0,04g+0,007g<br />

N6;N120<br />

tab. 240mg+ 180mg+ 30mg N10;<br />

N6<br />

tab. N10 Liuks<br />

tab. 240mg+<br />

180mg+30mg N10<br />

tab. 240mg+<br />

190mg+ 30mg N10<br />

SC ‘Concern Stirol’<br />

Leksredstva<br />

Liuks<br />

Medicata filia<br />

Betaini citras gran. 10g/100g 100g; 200g Beaufour Ipsen<br />

modi-fied<br />

-release tab.<br />

240mg+ 10mg N7 Schering-Plough<br />

1139. Claritine Loratadinum syrup 1mg/ml 120ml SP Labo<br />

1140. Claritine Loratadinum tab. 10mg N10;N30;N100 SP Labo<br />

1141. Clemastinum Clemastinum syrup 10mg/100ml Polfa Warsaw<br />

1142. Clemastinum Clemastinum tab. 1mg<br />

N30; N100<br />

Polfa Warsaw<br />

1143. Clenbuterol Clenbuteroli hydrochloridum sir. 5µg/5ml 100ml Balkanpharma-<br />

Troyan<br />

1144. Clexane Enoxaparinum natricum sol. for inj. 60mg/0,6ml pre-filled syringe<br />

N2<br />

1145. Clexane Enoxaparinum natricum sol. for inj. 100mg/ml pre-filled syringe<br />

N2<br />

1146. Clexane Enoxaparinum natricum sol. for inj. 40mg/0,4ml pre-filled syringe<br />

N2; N10<br />

1147. Clexane Enoxaparinum natricum sol. for inj. 20mg/0,2ml pre-filled syringe<br />

N2; N10<br />

1148. Clexane Enoxaparinum natricum sol. for inj. 80mg/0,8ml pre-filled<br />

syringeN2<br />

1149. Climara duo Estradiolum; Estradiolum+<br />

Levonorgestrelum<br />

transdermal<br />

patches (phase<br />

I+phase II)<br />

1150. Climara-100 Estradiolum transdermal<br />

patch<br />

1151. Climara-50 Estradiolum transdermal<br />

patch<br />

Rhone-Poulenc<br />

Rorer<br />

Rhone-Poulenc<br />

Rorer<br />

Rhone-Poulenc<br />

Rorer<br />

Rhone-Poulenc<br />

Rorer<br />

Rhone-Poulenc<br />

Rorer<br />

3mg; 2,5mg+ 1mg N(4+4) Ethical<br />

Pharmaceuticals<br />

7,8mg/25cm 2 N4; N12 Schering<br />

3,9mg/ 12,5cm 2 N4; N12 Schering


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 167<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1152. Climara-75 Estradiolum transdermal<br />

patch<br />

1153. Climen balta tab.: Estradioli valeras;<br />

rausva tab.: Estradioli valeras+<br />

Cyproteroni acetas<br />

sugar-coated<br />

tab.<br />

Strength Manufacturer<br />

5,7mg/ 18,8cm2 (0,075mg/<br />

day) N4; N12<br />

2mg; 2mg+1mg N21<br />

(11 white+<br />

10 rose)<br />

3M Pharmaceuticals/<br />

Schering<br />

Schering<br />

1154. Clindamycin 150 mg Clindamycinum caps., hard 150mg N16 Balkanpharma-<br />

Razgrad<br />

1155. Clindamycin-MIP 150 Clindamycinum film-coated<br />

tablets<br />

1156. Clindamycin-MIP 150mg/ml Clindamycinum solution for<br />

injection<br />

1157. Clindamycin-MIP 150mg/ml Clindamycinum solution for<br />

injection<br />

1158. Clindamycin-MIP 150mg/ml Clindamycinum solution for<br />

injection<br />

1159. Clindamycin-MIP 300 Clindamycinum film-coated<br />

tablets<br />

1160. Clindamycin-MIP 600 Clindamycinum film-coated<br />

tablets<br />

150mg N6;N12;N16; N30 Chephasaar Chem.-<br />

Pharm. Fabrik GmbH<br />

150mg/ml 2ml amp. N1;N5 Chephasaar Chem.-<br />

Pharm. Fabrik GmbH<br />

150mg/ml 6ml amp. N1; N5 Chephasaar Chem.-<br />

Pharm. Fabrik GmbH<br />

150mg/ml 4ml amp. N1; N5 Chephasaar Chem.-<br />

Pharm. Fabrik GmbH<br />

300mg N6;N12; N16;N30 Chephasaar Chem.-<br />

Pharm. Fabrik GmbH<br />

600mg N6;N12; N16;N30 Chephasaar Chem.-<br />

Pharm. Fabrik GmbH<br />

1161. Clinofug D 50 Doxycyclinum film-coated tab. 50mg N50 Wolff<br />

1162. Clinoril Sulindacum tab. 200mg N20 MSD-Haarlem-<br />

Chibret<br />

1163. Clivarine Reviparinum natricum sol. for inj. 3436IU/0,6ml pre-filled<br />

syringe<br />

1164. Clivarine Reviparinum natricum sol. for inj. 1432 IU (anti-Xa)/0,25ml<br />

pre-filled syringe N5<br />

1165. Clonazepam Clonazepamum tab. 2mg<br />

N30<br />

1166. Clostilbegyt Clomifenum tab. 50mg N10 Egis<br />

1167. Clotam retard Acidum tolfenamicum sustainedrelease<br />

tab.<br />

300mg<br />

N30<br />

Knoll<br />

Vetter Pharma<br />

Polfa Tarchomin<br />

1168. Clotrimazolum Clotrimazolum cream 10mg/g 15g;20g Homeofarm<br />

1169. Clotrimazolum Clotrimazolum cream 10mg/g 20g Glaxo Wellcome<br />

1170. Clotrimazolum 100 mg Clotrimazolum vaginal tab. 100mg N6 Glaxo Wellcome<br />

1171. CoAprovel Irbesartanum+<br />

Hydrochlorothiazidum<br />

1172. CoAprovel Irbesartanum+<br />

Hydrochlorothiazidum<br />

tab. 150mg+<br />

12,5mg<br />

N28<br />

tab. 300mg+<br />

12,5mg<br />

N28<br />

1173. Coaxil Tianeptinum coated tab. 12,5mg<br />

N30<br />

1174. Co-Diovan 80/12,5 Valsartanum+<br />

Hydrochlorothiazidum<br />

film-coated tab. 80mg+ 12,5mg<br />

N28<br />

GEA<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

Servier<br />

Novartis Pharma<br />

1175. Codipar Paracetamolum supp. 250mg N10 Glaxo Wellcome<br />

Poznan


EN<br />

168 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

1176. Codipar Paracetamolum tab. 500mg N6; N10 Glaxo Wellcome<br />

Poznan<br />

1177. Codipar Paracetamolum supp. 500mg N10 Glaxo Wellcome<br />

Poznan<br />

1178. Codipront Codeinum+<br />

Phenyltoloxaminum<br />

1179. Codipront Codeinum+<br />

Phenyltoloxaminum<br />

1180. Codipront N Codeine-poly(styrene,<br />

divinylbenzene)sulfonate<br />

(Codeine)<br />

1181. Coffeinum-natrii benzoas amp.<br />

1ml N10<br />

sustainedrelease<br />

caps.<br />

30mg+10mg N10; N20 Mack<br />

syrup 200mg+66mg/100g 100g Mack<br />

capsules with<br />

sustained action<br />

140,25-180mg (30mg) N10 Heinrich Mack<br />

Nachf. GmbH & Co.<br />

KG<br />

Coffeinum-natrii benzoas sol. N10 Liuks<br />

1182. Cognitiv Selegilinum film-coated tab. 5mg<br />

N50; N100<br />

1183. Cognitiv Selegilinum film-coated tab. 10mg<br />

N50; N100<br />

1184. Colda Balm Salviae aetheroleum+Thuja<br />

aetheroleum+Pini pum.<br />

Aetheroleum +Camphora+Pini<br />

silv. aetheroleum+ d-<br />

Panthenolum<br />

1185. Coldact Chlorphenaminum+<br />

Phenylpropanolaminum<br />

1186. Coldact Chlorphenaminum+<br />

Phenylpropanolaminum<br />

gel 100mg+200mg+200mg+<br />

1g+200mg+5g/<br />

100ml 30g<br />

Ebewe<br />

Ebewe<br />

Sigmapharm<br />

syrup 2mg+ 10mg/5ml 60ml Ranbaxy<br />

caps. 8mg+50mg N10 Ranbaxy<br />

1187. Coldan Naphazolinum eye drops 10mg/10ml Sigmapharm<br />

1188. Coldan Nasal Drops Naphazolinum nasal drops 10mg/10ml Sigmapharm<br />

1189. Coldargan Silver protein+ Ephedrine<br />

laevulinate+Sodium<br />

laevulinate+Calcium laevulinate<br />

1190. Coldastop Nasen-Ol Retinolum+<br />

Tocopherolum<br />

1191. Coldistan Naphazolinum+<br />

Diphenhydraminum<br />

1192. Coldistan Diphenhydraminum+<br />

Phenylephrinum<br />

1193. Coldistan Naphazolinum+<br />

Diphenhydraminum<br />

1194. Coldrex Paracetamolum+ Coffeinum+<br />

Phenylephrini<br />

hydrochloridum+ Terpinum<br />

hydratum + Acidum<br />

ascorbicum<br />

1195. Coldrex Broncho Guaifenesinum+ Glucosum+<br />

Treacle<br />

1196. Coldrex HotRem Blackcurrant Paracetamolum+<br />

Phenylephrinum+ Acidum<br />

ascorbicum<br />

sol. 250mg+200mg+71mg+22mg/<br />

10ml 10ml<br />

nasal drops, sol. 15000IU+<br />

20mg/ml 20ml<br />

Sigmapharm<br />

Allphamed Pharbil/<br />

Desitin<br />

nasal drops 5mg+10mg/ 100g 10ml Sigmapharm<br />

nasal ointment 200mg+200mg/100g 8g Sigmapharm<br />

eye drops 5mg+10mg/<br />

10ml 10ml<br />

capsule-shaped<br />

tablet<br />

500mg+ 25mg+ 5mg+ 20mg+<br />

30mg N12;N24<br />

syrup 100mg+ 3g+ 1,35g/5ml<br />

100ml; 160ml<br />

powder for oral<br />

sol.<br />

750mg+ 10mg+ 60mg/5g<br />

sachet N5; N10<br />

Sigmapharm<br />

SmithKline Beecham<br />

Wrafton Laboratories<br />

SmithKline Beecham


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 169<br />

No. Commercial name General name<br />

1197. Coldrex HotRem Lemon Paracetamolum+<br />

Phenylephrinum+ Acidum<br />

ascorbicum<br />

1198. Coldrex LaryPlus citrinu˛ skonio Hexylresorcinolum +<br />

Benzalkonii chloridum<br />

1199. Coldrex Laryplus Lozenges<br />

Blackcurrant Flavour<br />

Hexylresorcinolum+<br />

Benzalkonii chloridum<br />

1200. Coldrex MaxGrip Lemon Paracetamolum+<br />

Phenylephrinum+<br />

Acidum ascorbicum<br />

Pharmaceutical<br />

form<br />

powder for oral<br />

sol.<br />

Strength Manufacturer<br />

750mg+ 10mg+ 60mg/5g<br />

sachet N5;N10<br />

SmithKline Beecham<br />

lozenges 2,5mg+1,2mg N24 Wrafton Laboratories<br />

lozenges 2,5mg+ 1,2mg N24 Wrafton Laboratories<br />

powder for oral<br />

sol.<br />

1g+10mg+<br />

40mg/6,4g<br />

in sachets<br />

N5; N10<br />

SmithKline Beecham<br />

1201. Colloidal Silver (Collargol) Argentum colloidale subst. Ag 70-75% 10kg; 25kg; 50kg Laboratorios Argenol<br />

1202. Colocynthis-Homaccord Citrullus colocynthis D2+<br />

Citrullus colocynthis D10 +<br />

Citrullus colocynthis D30 +<br />

Citrullus colocynthis D200 +<br />

Gnaphalium polycephalum D1<br />

+Gnaphalium polycephalum<br />

D10 +Gnaphalium<br />

polycephalum D30 +<br />

Gnaphalium polycephalum<br />

D200<br />

1203. Cololyt Natrii sulfas anhydricus+ Natrii<br />

chloridum+Kalii chloridum+<br />

Natrii hydrogencarbonas+<br />

Macrogolum 4000<br />

1204. Colposeptine Promestrienum+<br />

Chlorquinaldolum<br />

oral drops 800mg+ 800mg+ 800mg+<br />

800mg+ 200mg+ 200mg+<br />

200mg+ 200mg/ 100g 30ml;<br />

100ml<br />

granules for<br />

oral sol.<br />

5,68g+1,46g+0,745g+<br />

1,68g+59g/1l N3<br />

Heel<br />

Spirig<br />

vaginal tab. 10mg+ 200mg N18 Theramex<br />

1205. Colpotrophine Promestrienum cream 150mg/15g 15g Theramex<br />

1206. Colpotrophine Promestrienum vaginal caps. 10mg N10 Theramex<br />

1207. Combivent Ipratropii bromidum +<br />

Salbutamolum<br />

1208. Combivent Ipratropii bromidum+<br />

Salbutamolum<br />

metered dose<br />

inhaler<br />

nebuliser<br />

solution<br />

20µg+120µg/ dose<br />

200 doses<br />

0,5mg+ 2,5mg/2,5ml unit<br />

dose vials N10;N20;N40;N60;<br />

N100<br />

Boehringer<br />

Ingelheim<br />

Boehringer<br />

Ingelheim<br />

1209. Combivir Lamivudinum+ Zidovudinum tab. 150mg+ 300mg N60 Glaxo Wellcome<br />

1210. Compleven Solution A (Amino acids<br />

solution) +Solution B (Solution<br />

with glucose and electrolytes)+<br />

Solution C<br />

(Fat emulsion)<br />

emulsion for<br />

inf.<br />

2500ml three chamber<br />

bag:1000ml solution A +<br />

1000ml solution B+ 500ml<br />

solution C N1; N3<br />

1211. Comtess Entacaponum film-coated tab. 200mg<br />

N30; N60; N100; N350<br />

1212. Contemnol Lithii carbonas slow-release<br />

tab.<br />

1213. Contractubex Cepae extractum fluidum+<br />

Heparinum natricum+<br />

Allantoinum<br />

1214. Controloc Pantoprazolum gastro-resistant<br />

tab.<br />

1215. Controloc Pantoprazolum gastro-resistant<br />

tab.<br />

500mg<br />

N100<br />

gel 100mg+50UI+10mg/g<br />

20g<br />

Fresenius Kabi<br />

Orion<br />

Slovakofarma<br />

Merz+Co<br />

20mg N14;N28;N56 Byk Gulden<br />

40mg N14;N28 Byk Gulden


EN<br />

170 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1216. Convulex Acidum valproicum caps. 150mg<br />

N100<br />

1217. Convulex Acidum valproicum caps. 300mg<br />

N100<br />

1218. Convulex Acidum valproicum caps. 500mg<br />

N100<br />

Strength Manufacturer<br />

Gerot Pharmazeutika<br />

Gerot Pharmazeutika<br />

Gerot Pharmazeutika<br />

1219. Convulex Natrii valproas oral drops 300mg/ml 100ml Gerot Pharmazeutika<br />

1220. Convulex Natrii valproas syrup for<br />

children<br />

1221. Copegus 200mg Ribavirinum film-coated<br />

tablets<br />

1222. Cordafen Nifedipinum coated tab. 10mg<br />

N50<br />

1223. Cordaflex Nifedipinum film-coated tab. 10mg<br />

N100<br />

1224. Cordaflex retard Nifedipinum film-coated tab. 20mg<br />

N60<br />

50mg/ml 100ml Gerot Pharmazeutika<br />

200mg N42;N168 F.Hoffmann-La<br />

Roche AG<br />

1225. Cordanum 100 Talinololum drag. 100mg N100 AWD<br />

1226. Cordanum 50 Talinololum film-coated tab. 50mg<br />

N50<br />

Polpharma<br />

1<strong>227</strong>. Cordarone 150 mg/3 ml Amiodaronum sol. for inj. 150mg/3ml amp. N6 Sanofi Winthrop<br />

1228. Cordarone 200 mg Amiodaronum scored tab. 200mg<br />

N30<br />

1229. Cordiaminum pro inj. 1ml<br />

N10<br />

Egis<br />

Egis<br />

AWD<br />

Cordiaminum sol. N10 Liuks<br />

1230. Cordipin Nifedipinum film-coated tab. 10mg<br />

N50<br />

1231. Cordipin Retard Nifedipinum prolongedrelease<br />

tab.<br />

1232. Cordipin XL Nifedipinum modified release<br />

tab.<br />

1233. Co-Renitec 10 mg/25 mg Enalaprilum+ Hydrochlorothiazidum<br />

1234. Co-Renitec 20 mg/12,5 mg Enalaprilum+<br />

Hydrochlorothiazidum<br />

20mg<br />

N30<br />

40mg<br />

N20<br />

Sanofi Winthrop<br />

KRKA<br />

KRKA<br />

KRKA<br />

tab. 10mg+25mg N30 MSD<br />

tab. 20mg+ 12,5mg<br />

N28<br />

1235. Corinfar Nifedipinum drag. 10mg N50 AWD<br />

1236. Corinfar Nifedipinum film-coated tab. 10mg N30;N50; N100 AWD<br />

1237. Corinfar retard Nifedipinum sustainedrelease<br />

drag.<br />

1238. Corinfar retard Nifedipinum slow-release<br />

tab.<br />

20mg<br />

N30; N50; N100<br />

MSD<br />

AWD<br />

20mg N30;N50; N100 AWD<br />

1239. Corinfar uno 40 Nifedipinum tablets 40mg N20;N50; N100 AWD. pharma<br />

GmbH & Co.KG<br />

1240. Corotrope Milrinonum sol. for inj. 10mg/10ml N10 Sanofi Winthrop<br />

1241. Corpril Ramiprilum capsules 1,25mg N10 Ranbaxy<br />

Laboratories Limited


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 171<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

1242. Corpril Ramiprilum capsules 2,5mg N10 Ranbaxy<br />

Laboratories Limited<br />

1243. Corpril Ramiprilum capsules 5mg N10 Ranbaxy<br />

Laboratories Limited<br />

1244. Corsodyl mouthwash Chlorhexidini gluconas oromu-cosal<br />

sol.<br />

0,2% 300ml SmithKline Beecham<br />

1245. Cortineff Fludrocortisoni acetas tab. 100µg Polfa Pabianice<br />

1246. Cortomycetin ung. Hydrocortisonum/<br />

Chloramphenicolum<br />

ointment 15g; 25g; 30g Liuks<br />

1247. Corvalolum Compositum sol. 25 ml Liuks<br />

1248. Corvitol 100 Metoprololum tab. 100mg N30; N50; N100 Berlin-Chemie<br />

1249. Corvitol 50 Metoprololum tab. 50mg N30; N50; N100 Berlin-Chemie<br />

1250. Coryol 12,5 Carvedilolum tab. 12,5mg N30 KRKA<br />

1251. Coryol 25 Carvedilolum tab. 25mg N30 KRKA<br />

1252. Coryol 6,25 Carvedilolum tab. 6,25mg N30 KRKA<br />

1253. Coryzalia Allium cepa 3CH+ Sabadilla<br />

3CH+ Gelsemium 3CH+<br />

Belladonna 3CH+ Kalium<br />

bichro- micum 3CH+ Pulsatilla<br />

3CH<br />

film-coated tab. 0,333mg+ 0,333mg+<br />

0,333mg+ 0,333mg+<br />

0,333mg<br />

N40<br />

1254. Cosopt Dorzolamidum+ Timololum eye drops, sol. 20mg+ 5mg/ml 5ml MSD-Chibret<br />

1255. Co-Trimoxazol Sulfamethoxazolum+<br />

Trimethoprimum<br />

1256. Co-Trimoxazole 480 mg Sulfamethoxazolum+<br />

Trimethoprimum<br />

1257. Cotrimox-Wolff Sulfamethoxazolum+<br />

Trimethoprimum<br />

1258. Cotrimox-Wolff forte Sulfamethoxazolum+<br />

Trimethoprimum<br />

1259. Cotrimox-Wolff Saft Sulfamethoxazolum+<br />

Trimethoprimum<br />

tab. 400mg+ 80mg<br />

N20<br />

Boiron<br />

Balkanpharma-<br />

Dupnitza<br />

tab. 400mg+ 80mg N20 Pharmamed/ Ilsanta<br />

tab. 400mg+ 80mg N10; N20 Wolff<br />

tab. 800mg+ 160mg N10; N20 Wolff<br />

syrup 200mg+ 40mg/5ml 100ml Wolff<br />

1260. Coverex Perindoprilum tab. 4mg N30 Egis<br />

1261. Cozaar<br />

100 mg<br />

Losartanum film-coated tab. 100mg<br />

N7; N14;N28<br />

1262. Cozaar Losartanum film-coated tab. 12,5mg N21; N28 MSD<br />

1263. Cozaar Losartanum scored filmcoated<br />

tab.<br />

1264. Cralonin Crataeguso+ Spigelia D2+<br />

Kalium carbonicum D3<br />

1265. Cresophene Dexamethasonum+ Thymolum sol. for dental<br />

use<br />

50mg<br />

N28<br />

oral drops 70ml+1ml+<br />

1ml/100ml (Ethanolum<br />

45 vol-%) 30ml;100ml<br />

0,111g+5g/<br />

100g 13ml<br />

MSD<br />

MSD<br />

Heel<br />

Septodont<br />

1266. Crismel Omeprazolum caps., hard 20mg N7;N14; N28 Laboratorios Dr.<br />

Esteve<br />

1267. Crixivan Indinavirum caps. 400mg<br />

N180<br />

MSD


EN<br />

172 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1268. Crixivan Indinavirum caps. 200mg<br />

N360<br />

1269. Crixivan Indinavirum caps. 333mg<br />

N135<br />

Strength Manufacturer<br />

1270. Crixivan Indinavirum caps., hard 100mg N180 MSD<br />

1271. Cromogen<br />

5 mg Easi-Breathe<br />

1272. Cromogen<br />

5 mg Inhaler<br />

Dinatrii cromoglicas aerosol for<br />

inhal., susp.<br />

Dinatrii cromoglicas aerosol for<br />

inhal., susp.<br />

1273. Cromogen 1mg Inhaler Dinatrii cromoglicas aerosol for<br />

inhal., susp.<br />

1274. Cromo-ratiopharm Dosier-<br />

Aerosol<br />

Dinatrii cromoglicas metered dose<br />

aerosol<br />

MSD<br />

MSD<br />

5mg/dose 112doses Galena<br />

5mg/dose 112doses Galena<br />

1mg/dose 200doses Galena<br />

1mg/0,05ml 10ml Merckle<br />

1275. Cromosol Natrii cromoglicas nasal spray 20mg/ml 28ml ICN Polfa Rzeszow<br />

1276. Cropoz Cromoglicid acid, disodium<br />

salt<br />

1277. Cruroheel S Mercurius praecipitatus ruber<br />

D8+Apis mellifica D4+<br />

Lycopodium clavatum D4+<br />

Acidum silicicum D6+<br />

Hamamelis virginiana D4+<br />

Carbo vegetabilis D8+Pulsatilla<br />

pratensis D6<br />

aerosol 5mg/dose 15ml Polfa Poznan<br />

tab. 30mg+30mg+ 30mg+30mg+<br />

60mg+60mg+ 60mg<br />

1278. Cuprenil Penicillaminum coated tab. 250mg<br />

N30; N100<br />

1279. Curam Amoxicillinum+ Acidum<br />

clavulanicum<br />

1280. Curam Amoxicillinum+ Acidum<br />

clavulanicum<br />

1281. Curam Amoxicillinum+ Acidum<br />

clavulanicum<br />

powder for oral<br />

susp.<br />

Heel<br />

Polfa Kutno<br />

125mg+ 31,25mg/5ml 60ml Biochemie<br />

film-coated tab. 500mg+ 125mg N14; N16 Biochemie<br />

powder for oral<br />

susp.<br />

250mg+ 62,5mg/5ml 60ml Biochemie<br />

1282. Curantyl N 75 Dipyridamolum film-coated tab. 75mg N40 Berlin-Chemie<br />

(Menarini Group)<br />

1283. Curiosin Zinci hyaluronas sol. 20,5mg/10ml 10ml Gedeon Richter<br />

1284. Curiosin gel Sodium hyaluronate+ Zinc<br />

chloride<br />

1285. Curosurf Phospholipid fraction from<br />

porcine lung<br />

gel 15mg+ 5mg/15g Gedeon Richter<br />

susp. for<br />

intratracheal<br />

administration<br />

80mg/ml 1,5ml vial N1 Chiesi Farmaceutici<br />

1286. Cutivate Fluticasonum lotion 0,05% 30ml Glaxo Wellcome<br />

GmbH & Co.<br />

1287. Cutivate Cream Fluticasoni propionas cream 500µg/g 15g;30g;100g Glaxo<br />

1288. Cutivate Ointment Fluticasoni propionas ointment 50µg/g 15g;30g;100g Glaxo<br />

1289. Cuxanorm 100 Atenololum tab. 100mg<br />

N50<br />

1290. Cuxanorm 25 Atenololum tab. 25mg N50 TAD<br />

1291. Cuxanorm 50 Atenololum tab. 50mg N50 TAD<br />

TAD


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 173<br />

No. Commercial name General name<br />

1292. Cyclo — Progynova Estradioli valeras; Estradioli<br />

valeras+ Norgestrelum<br />

1293. Cyclo 3 Fort Fluid extr.of Ruscus<br />

aculeatus,containing 22%<br />

totalsterolic heterosides+<br />

Hesperidin<br />

methyl chalcone+ Ascorbic<br />

acid<br />

Pharmaceutical<br />

form<br />

sugar-coated<br />

tab. (white;<br />

light brown)<br />

Strength Manufacturer<br />

2mg; 2mg+ 0,5mg N21 Schering<br />

caps. 150mg+ 150mg+ 100mg<br />

N20; N30; N60<br />

1294. Cyclodol Trihexyphenidylum tab. 2mg<br />

N50<br />

Simaphac<br />

Tallinna<br />

Farmaatsiatehase<br />

1295. Cyclogyl 1 % Cyclopentolatum eye drops, sol. 10mg/ml 15ml Alcon-Couvreur<br />

1296. Cyclonamine Etamsilatum tab. 250 mg N30 Liuks<br />

1297. Cyclophosphamide Cyclophosphamidum powder for inj. 200mg N1 Taro International<br />

1298. Cyclophosphamide Cyclophosphamidum powder for inj. 200mg N10 Orion<br />

1299. Cyclophosphamide Cyclophosphamidum powder for inj. 500mg N10 Orion<br />

1300. Cyclophosphamide Cyclophosphamidum tab. 50mg N30; N100 Orion<br />

1301. Cyclophosphamide Cyclophosphamidum powder for inj. 1000mg N1 Taro for Teva<br />

1302. Cyclophosphamide Cyclophosphamidum powder for inj. 500mg N1 Taro International<br />

1303. Cyclophosphamide Cyclophosphamidum powder for inj. 100mg N10 Orion<br />

1304. Cyclophosphamide Cyclophosphamidum powder for inj. 1000mg N10 Orion<br />

1305. Cyclophosphanum Cyclophosphamidum powder for inj. 200mg<br />

N30<br />

1306. Cycloplatin 200 inj. sicc. Carboplatinum powder for sol.<br />

for inj.<br />

1307. Cycloplatin 50 inj. sicc. Carboplatinum powder for sol.<br />

for inj.<br />

OlainFarm<br />

200mg/ vial N1; N5 Lachema<br />

50mg/vial N; N10 Lachema<br />

1308. Cyclovir Aciclovirum tab. 200mg N10; N100 Cadila<br />

1309. Cyclovir Aciclovirum cream 50mg/g 5g Cadila<br />

1310. Cyklokapron Acidum tranexamicum tab. 500mg Pharmacia AB<br />

1311. Cyklokapron Acidum tranexamicum sol. for inj. 100mg/ml 5ml amp. N10 Pharmacia & Upjohn<br />

1312. Cykrina Medroxyprogesteronum tab. 5mg<br />

N42<br />

1313. Cykrina Medroxyprogesteronum tab. 10mg<br />

N42<br />

1314. Cymevene Ganciclovirum caps. 250mg N84 Roche<br />

1315. Cymevene Ganciclovirum powder for sol.<br />

for inf.<br />

500mg vial Roche<br />

Wyeth Medica<br />

Wyeth Medica<br />

1316. Cynacholin Cynarae extractum fluidum liquid 100g Phytopharm Kle˛ka<br />

Spolka Akcyjna<br />

1317. Cynarex Extr. Cynarea sicc. tab. 250mg N30 Herbapol Wroclaw<br />

1318. Cystosol Sorbitolum+ Acidum aceticum<br />

glaciale<br />

irrigation sol. 50mg+ 2,5mg/ml 1000ml Unimedic<br />

1319. Cytarabine Cytarabinum sol. for inj. 1g/50ml vials N1 Faulding


EN<br />

174 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

1320. Cytarabine Cytarabinum sol. for inj. 500mg/25ml vials N1 Faulding<br />

1321. Cytarabine Cytarabinum sol. for inj. 100mg/5ml vials N5 Faulding<br />

1322. Cytosar Cytarabinum lyophilized<br />

powder for<br />

reconstitution<br />

1323. Cytosar Cytarabinum lyophilized<br />

powder for<br />

reconstitution<br />

1324. Cytosar Cytarabinum lyophilized<br />

powder for<br />

reconstitution<br />

100mg/vial+<br />

amp. of 5ml with diluent<br />

(Benzyl alcohol 45mg/5ml) N1<br />

500mg/vial+ amp.of 10ml<br />

with diluent (Benzyl alcohol<br />

90mg/10ml) N1<br />

1g/vial<br />

N1<br />

1325. Cytotec Misoprostolum tab. 0,2mg N56 Searle<br />

1326. Cytoxan Cyclophosphamidum powder for inj. 1000mg<br />

N6 vial<br />

1327. Cytoxan Cyclophosphamidum tab. 50mg<br />

N100<br />

1328. Cytoxan Cyclophosphamidum powder for inj. 200mg<br />

N12 vial<br />

1329. Cytoxan Cyclophosphamidum powder for inj. 500mg<br />

N12 vial<br />

1330. Cytoxan Cyclophosphamidum tab. 25mg<br />

N100<br />

1331. Cytoxan Cyclophosphamidum powder for inj. 2000mg<br />

N6 vial<br />

1332. Cytoxan Cyclophosphamidum powder for inj. 100mg<br />

N12 vial<br />

1333. D. T COQ/D.T.P. (single dose) Purified diphtheria toxoid+<br />

Purified tetanus toxoid+<br />

Bordetella pertussis, inactivated<br />

suspension<br />

1334. D. T. COQ/D.T.P. (multidose) Purified diphtheria toxoid+<br />

Purified tetanus toxoid+<br />

Bordetella pertussis, inactivated<br />

suspension<br />

1335. D. T. Vax (multidose) Purified diphtheria toxoid+<br />

Purified tetanus toxoid<br />

1336. D. T. Vax (single dose) Purified diphtheria toxoid+<br />

Purified tetanus toxoid<br />

1337. Dacarbazin Lachema 100 inj.<br />

sicc.<br />

1338. Dacarbazin Lachema 200 inj.<br />

sicc.<br />

1339. Daivobet Calcipotriolum+<br />

Betamethasonum<br />

Dacarbazinum powder for sol.<br />

for inj.<br />

Dacarbazinum powder for sol.<br />

for inj.<br />

susp.for inj. >30IU+>60IU+>4IU/0,5ml<br />

pre-filled syringe<br />

N1<br />

susp.for inj. >30IU+>60IU+>4IU/0,5ml<br />

5ml vial (10doses);<br />

10ml vial<br />

(20 doses)<br />

susp. for inj. 30IU+ 40IU/dose 0,5ml 5ml<br />

vial (10 doses) N1;N10<br />

susp. for inj. >30IU+ >40IU/ 0,5ml<br />

pre-filled syringe N1;N20<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Pasteur Merieux<br />

Pasteur Merieux<br />

Pasteur Merieux<br />

Pasteur Merieux<br />

100mg/vial N10 Lachema<br />

200mg/vial N10 Lachema<br />

ointment 50µg+<br />

0,5mg/g 15g; 30g; 60g<br />

1340. Daivonex Calcipotriolum ointment 50µg/g<br />

30g<br />

1341. Daivonex Calcipotriolum scalp sol. 50µg/ml 60ml Leo<br />

1342. Daivonex Calcipotriolum cream 50µg/g 30g Leo<br />

Leo Laboratories<br />

Leo


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 175<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

1343. Daktarin Miconazolum cream 20mg/g 15g; 30g Janssen<br />

1344. Daktarin oral gel Miconazolum oral gel 20mg/g 40g Janssen<br />

1345. Dalacin Clindamycinum vaginal cream 20mg/g 40g with 7 applicators<br />

per pack N1<br />

1346. Dalacin C Clindamycinum caps. 150mg<br />

N16<br />

1347. Dalacin C Clindamycinum caps. 300mg<br />

N16<br />

1348. Dalacin C Clindamycinum sol. for inj. 150mg/ml 2ml;4ml;6ml<br />

amp.N1<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

1349. Dalacin T Clindamycinum topical sol. 10mg/ml 30ml Pharmacia & Upjohn<br />

1350. Dalacin Vaginal Ovule Clindamycinum ovules 100mg N1 (3×100mg with 1<br />

applicator)<br />

1351. Daleron Paracetamolum tab. 500mg N12 KRKA<br />

1352. Daleron Paracetamolum oral susp. 120mg/5ml 100ml KRKA<br />

1353. Daleron Cold 3 Paracetamolum+<br />

Pseudoephedrinum+<br />

Dextromethorphanum<br />

1354. Danol<br />

200 mg<br />

film-coated tab. 325mg+<br />

30mg+15mg N12; N24<br />

Danazolum caps. 200mg<br />

N100<br />

1355. Dantu˛ lašai Menthae piperitae<br />

aetheroleum,<br />

Comphora,Tinctura Valerianae<br />

1356. Dapril 10 Lisinoprilum tab. 10mg<br />

N30<br />

1357. Dapril 20 Lisinoprilum tab. 20mg<br />

N20<br />

1358. Dapril 5 Lisinoprilum tab. 5mg<br />

N30<br />

Pharmacia & Upjohn<br />

KRKA<br />

Sanofi Winthrop<br />

solution 10ml Vilniaus farmacijos<br />

fabrikas<br />

Medochemie<br />

Medochemie<br />

Medochemie<br />

1359. Daraprim Pyrimethaminum tab. 25mg N30; N500 Glaxo Wellcome<br />

1360. Dayrun Oxaprosinum coated tablets 600mg N6;N10;N20; N30;<br />

N60;<br />

N100<br />

1361. Deap Heat Spray Methylis nicotinas+ 2-<br />

Hydroxyethylsalicylas+<br />

Methylis salicylas+ Ethylis<br />

salicylas<br />

1362. Debecylin Benzathini benzylpenicillinum powder for sol.<br />

for inj. i. m.<br />

1363. Debecylin Benzathini benzylpenicillinum powder for sol.<br />

for inj. i. m.<br />

1364. Decapeptyl Depot (Miglyol) Triptorelinum depot caps. and<br />

solvent for<br />

susp.for inj.<br />

Cosmo S.p.A.<br />

Production/Helsinn<br />

Birex Pharmaceutical<br />

Ltd.<br />

aerosol 1,6%+ 5%+ 1%+5% 150ml CCI Industries<br />

600000IU<br />

N20<br />

1200000IU<br />

N20<br />

1365. Decaris Levamisolum tab. 150mg<br />

N1<br />

3,75mg N1; N3 (depot caps.<br />

and syrige1ml with solvent)<br />

Polfa Tarchomin<br />

Polfa Tarchomin<br />

Ferring<br />

Gedeon Richter


EN<br />

176 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1366. Decaris Levamisolum tab. 50mg<br />

N2<br />

1367. Decatylen Dequalinii chloridum +<br />

Dibucaini hydrochloridum<br />

Strength Manufacturer<br />

lozenges 0,25mg+ 0,03mg N20 Mepha<br />

Gedeon Richter<br />

1368. Deep Freeze Cold Gel Racementholum gel 2% w/w 35g; 50g; 100g Mentholatum<br />

1369. Deep Freeze Spray Levomentholum+ Pentanum aerosol spray 2% w/w+<br />

40% w/w 135g (200ml)<br />

1370. Deep Heat Rub Methylis salicylas+<br />

Mentholum+ Ol.Eucalypti+<br />

Ol.Terpentini<br />

1371. Deep Relief Ibuprofenum+<br />

Levomentholum<br />

cream 12,8%+ 5,91%+ 1,97%+ 1,47%<br />

15g;35g; 67g;100g<br />

Mentholatum<br />

Mentholatum<br />

gel 5%+3% 15g;30g;50g Mentholatum<br />

1372. Deflegmin Ambroxolum tab. 30mg N20; N40 ICN Polfa Rzeszow<br />

1373. Deflegmin Ambroxolum oral drops, sol. 7,5mg/ml (25drops) 50ml ICN Polfa Rzeszow<br />

1374. Deksametazonas Dexamethasonum eye drops 5mg/5ml Endokrininiai<br />

preparatai<br />

1375. Delacet Tinct.Delphini+ Acidum<br />

aceticum<br />

sol. 91,7%+ 8,3% 100ml Herbapol Cracow<br />

1376. Delagil Chloroquine phosphate sol. for inj. 250mg/5ml N5 Egis<br />

1377. Dendrid Idoxuridinum eye drops 1mg/ml<br />

15ml<br />

Alcon-Couvreur<br />

1378. Denerel Ketotifenum tab. 1mg N30; N100 Medochemie<br />

1379. De-Nol Bismuthi trioxidum coated tab. 120mg N112;N56 Yamanouchi Europe<br />

1380. Dentinox-Gel N (Teething Gel<br />

for Children)<br />

Tinct.Chamomillae+ Lidocaini<br />

hydrochloricdum+<br />

Polidocanolum 600<br />

gel 150mg+ 3,4mg+ 3,2mg/g 10g Dentinox<br />

1381. Dentol Benzocainum gel 10% 15g Pharmascience Inc.<br />

1382. Dentol-Baby Benzocainum gel 7,5% 15g Pharmascience Inc.<br />

1383. Dentosept Extractum fluidum (0,65:1)<br />

ex: Quercus cortex+<br />

Matricaraiae flos+<br />

Salviae folium+Arnicae herba+<br />

Calami rhizoma+<br />

Menthae piperitae herba+<br />

Thymi herba (Ethanolum 60-<br />

70%)<br />

1384. Dentosept A Matricariae flos+Quercus<br />

cortex+Salviae folium+Arnicae<br />

herba+Calami rhizoma+<br />

Menthae piperitae herba+<br />

Thymi herba+<br />

Anaesthesinum+ Natrium<br />

tetraboricum<br />

sol. 13g+13g+13g+6,5g+6,5g+<br />

6,5g+<br />

6,5g/100g 100g<br />

liquid 6,5g+6,5g+6,5g+ 3,25g+<br />

3,25g+ 3,25g+ 3,25g+2g+<br />

4g/100g (Ethanolum 32-37%)<br />

25g<br />

Herbapol Kle˛ka<br />

Phytopharm Kle˛ka<br />

1385. Depakine Natrii valproas syrup 200mg/3,47ml 150ml Sanofi Winthrop<br />

1386. Depakine Natrii valproas sol. for inj. 400mg/4ml Chinoin<br />

1387. Depakine Chrono<br />

500 mg<br />

Natrii valproas+ Acidum<br />

valproicum<br />

sustainedrelease<br />

tab.<br />

333mg+145mg N40 Laboratoires Labaz


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 177<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1388. Depakine Chrono 300 Natrii valproas scored<br />

sustainedreleasefilmcoated<br />

tab.<br />

1389. Depakine Chrono 500 Natrii valproas scored<br />

sustainedreleasefilmcoated<br />

tab.<br />

300mg<br />

N100<br />

500mg<br />

N30<br />

1390. Depersolon Mazipredonum sol. for inj. 30mg/ml<br />

N3<br />

1391. Depo-Medrol Methylprednisoloni acetas susp. for inj. 40mg/ml<br />

1ml; 2ml; 5ml vial N1<br />

1392. Deponit 10 Glyceroli trinitras<br />

(Nitroglycerinum)<br />

transdermal<br />

patch<br />

1393. Deponit 5 Glyceroli trinitras transdermal<br />

patch<br />

Strength Manufacturer<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

Gedeon Richter<br />

Pharmacia & Upjohn<br />

32mg/32cm 2 (10mg/24h) N10 Schwarz Pharma<br />

16mg/24h<br />

N10<br />

Schwarz Pharma<br />

1394. Depo-Provera Medroxyprogesteronum sol. for inj. 150mg/ml 1ml; 3,3ml; 6,7ml Pharmacia & Upjohn<br />

1395. Deprenon Fluoxetinum caps., hard 20mg N20 Slovakofarma<br />

1396. Deprexan Fluoxetinum caps. 20mg Sanitas<br />

1397. Deprexetin Fluoxetinum caps. 20mg<br />

N30<br />

ICN Polfa Rzeszow<br />

1398. Deprimaks 20 mg Fluoxetinum caps., hard 20mg N14 Generics/Grindeks<br />

1399. Dercome clear Benzoylis peroxidum susp. 4g/100g 100g Wolff<br />

1400. Derinat Dezoksinukleo rūgšties natrio<br />

druska<br />

1401. Dermabion Faex medicinalis+ Retinolum+<br />

Calcii pantothenas+<br />

Thiaminum+ Riboflavinum+<br />

Pyridoxinum+<br />

Nicotinamidum+ Zincum<br />

sol. 2,5mg/ml 10ml Technomedservis<br />

sugar-coated<br />

tab.<br />

175mg+ 1000IU+ 5mg+<br />

0,5mg+ 0,5mg+ 0,5mg+<br />

2,5mg+ 4mg N60<br />

1402. Dermatin Ketoconazolum shampoo 20mg/g 60ml;120ml Delta<br />

1403. Dermazin cream 1 % Sulfadiazinum argentum cream 10mg/g 50g;250g Lek<br />

1404. Dermestril 50 Estradiolum transdermal<br />

patch<br />

KRKA<br />

4mg/18cm 2 N8; N24; N26 LTS<br />

1405. Dermilon Paste Zinci oxidum+ Ol.Jecoris paste 22g+ 1,23g/100g 60g;120g Redel<br />

1406. Dermofug Dodecylbenzol-2,2',2''-nitrilotriethanolum+<br />

Ammonii<br />

dodecylsulfas<br />

sol. 12,75g+ 20g/100g 100ml;<br />

1000ml<br />

1407. Dermosolon Prednisolonum+ Clioquinolum ointment 5mg+30mg/g 5g Gedeon Richter<br />

1408. Dermovate Clobetasolum ointment 0,05375% w/w 5g; 10g; 25g;<br />

40g; 100g<br />

1409. Dermovate Clobetasolum cream 0,0525% w/w 5g; 15g; 25g;<br />

30g; 100g<br />

1410. Dermovate Scalp Application Clobetasolum sol. 0,05%<br />

25ml<br />

1411. Dernilan Allantoinum+ Acidum acidi<br />

nicotinici+ Acidum<br />

salicylicum+ Camphora<br />

ointment 300mg+ 250mg+ 100mg+<br />

1g/100g 20g;25g;35g<br />

Wolff<br />

Glaxo<br />

Glaxo<br />

Glaxo Wellcome<br />

Herbapol Wroclaw


EN<br />

178 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

1412. Desinfectol Chlorhexidini gluconas ad<br />

Ethanolum 70%<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

sol. 5mg/ml 1000ml Unimedic<br />

1413. Desitin Baby Powder Zinci oxidum+ Amylum powder 10%+ 88,2% 397g Pfizer<br />

1414. Desitin ointment Zinci oxidum cream 40% w/w 57g Pfizer<br />

1415. Desmopresino<br />

0,05 mg/ml tirpalas, nosies<br />

lašai<br />

Desmopressinum nasal drops, sol. 0,05 mg/ml Endokrininai<br />

preparatai<br />

1416. Deticene Dacarbazinum powder for inf. 200mg N10 Thissen<br />

1417. Deticene Dacarbazinum powder for inf. 100mg N10 Thissen<br />

1418. Detralex Mikronizuota, išgryninta<br />

flavanoidu˛ frakcija, kuria˛<br />

sudaro: Diosminum+<br />

Flavanoidai, apskaičiuoti pagal<br />

Hesperidinum<br />

1419. Detrusitol Tolterodini<br />

L-tartras<br />

1420. Detrusitol Tolterodini<br />

L-tartras<br />

film-coated tab. 500mg: 450mg+ 50mg<br />

N30<br />

film-coated tab. 1mg<br />

N28; N56<br />

film-coated tab. 2mg<br />

N28; N56<br />

Servier<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

1421. Dexamed Dexamethasonum tab. 0,5mg N100 Medochemie<br />

1422. Dexamethason Dexamethasonum sol. for inj. 4mg/ml<br />

1ml amp. N25<br />

1423. Dexamethason Dexamethasonum tab. 0,5mg<br />

N10<br />

1424. Dexamethasone 0,1 % Dexamethasonum eye drops,<br />

susp.<br />

1mg/ml<br />

10ml<br />

1425. Dexaven Dexamethasonum sol. for inj. 4mg/ml N10 Jelfa<br />

1426. Dexofan<br />

3 mg/ml<br />

1427. Dexofan<br />

30 mg<br />

Dextromethorphani<br />

hydrobromidum<br />

Dextromethorphani<br />

hydrobromidum<br />

KRKA<br />

KRKA<br />

Polfa Warsaw<br />

mixt. 3mg/ml, 200ml Nycomed Danmark/<br />

Nycomed SEFA<br />

tab. 30mg N10 Nycomed Danmark/<br />

Nycomed SEFA<br />

1428. Dexona Dexamethasonum tab. 0,5mg N10;N100 Cadila<br />

1429. Dexona Dexamethasonum sol. for inj. 4mg/ml 2ml amp. N1 Cadila<br />

1430. Dexona Dexamethasonum+<br />

Neomycinum<br />

1431. DexOptifen Dexibuprofenum tab. 300mg<br />

N20<br />

1432. DexOptifen Dexibuprofenum tab. 150mg<br />

N30<br />

1433. Dextrose<br />

20 % in water<br />

1434. Dextrose<br />

40 % in water<br />

1435. Dextrose 5 % in 0,9 % Sodium<br />

Chloride infusion<br />

eye/ear drops 1mg+5mg/ml 2,5ml;5ml Cadila<br />

Spirig<br />

Spirig<br />

Glucosum sol. for inj. 220g/ 1000ml 100ml;500ml Human<br />

Glucosum sol. for inf. 440g/1000ml 100ml; 500ml Human<br />

Glucosum monohydricum+<br />

Natrii chloridum<br />

sol. for inf. 55g+ 9g/1000ml 500ml Human<br />

1436. Dextrose 5 % in water Glucosum sol. for inf. 55g/1000ml 500ml Human


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 179<br />

No. Commercial name General name<br />

1437. Diabetosol Extr.comp.fl. 1:4 ex:<br />

Herb.Galegae officinalis+<br />

Peric.Phaseoli vulgaris+Rad.<br />

Taraxaci+Rhiz. Agropyri+Fol.<br />

Vaccinii vitis-idaeae;<br />

Ethanolum 25%<br />

Pharmaceutical<br />

form<br />

liquid 7,5g+7,5g+ 5g+2,5g+<br />

2,5g/100g 100g<br />

Strength Manufacturer<br />

1438. Diabrezide Gliclazidum tab. 80mg N40 Molteni<br />

1439. Diacarb Acetazolamidum tab. 250mg<br />

N24<br />

1440. Diane — 35 Cyproteroni acetas+<br />

Ethinylestradiolum<br />

1441. Dianel PD1 Glucose<br />

2,27 % w/v<br />

1442. Dianel PD1 Glucose<br />

1,36 % w/v<br />

1443. Dianel PD1 Glucose<br />

3,86 % w/v<br />

1444. Dianel PD4 Glucose<br />

1,36 % w/v<br />

1445. Dianel PD4 Glucose<br />

2,27 % w/v<br />

1446. Dianel PD4 Glucose<br />

3,86 % w/v<br />

Glucosum anhydricum+ Natrii<br />

chloridum+ Natrii lactas+<br />

Calcii chloridum dihydricum+<br />

Magnesii chloridum<br />

hexahydricum<br />

Glucosum anhydricum+ Natrii<br />

chloridum+ Natrii lactas+<br />

Calcii chloridum dihydricum+<br />

Magnesii chloridum<br />

hexahydricum<br />

Glucosum anhydricum+ Natrii<br />

chloridum+ Natrii lactas+<br />

Calcii chloridum dihydricum+<br />

Magnesii chloridum<br />

hexahydricum<br />

Glucosum anhydricum+ Natrii<br />

chloridum+ Natrii lactas+<br />

Calcii chloridum dihydricum+<br />

Magnesii chloridum<br />

hexahydricum<br />

Glucosum anhydricum+ Natrii<br />

chloridum+ Natrii lactas+<br />

Calcii chloridum dihydricum+<br />

Magnesii chloridum<br />

hexahydricum<br />

Glucosum anhydricum+ Natrii<br />

chloridum+ Natrii lactas+<br />

Calcii chloridum dihydricum+<br />

Magnesii chloridum<br />

hexahydricum<br />

sugar coated<br />

tab.<br />

sol. for<br />

peritoneal<br />

dialysis<br />

sol. for<br />

peritoneal<br />

dialysis<br />

sol. for<br />

peritoneal<br />

dialysis<br />

sol. for<br />

peritoneal<br />

dialysis<br />

sol. for<br />

peritoneal<br />

dialysis<br />

sol. for<br />

peritoneal<br />

dialysis<br />

2mg+<br />

0,035mg<br />

N21<br />

22,7g+5,7g+3,9g+257mg+<br />

152mg/1000ml 1500ml;<br />

2000ml;<br />

2500ml;<br />

5000ml<br />

13,6g+5,7g+<br />

3,9g+257mg+152mg/1000ml<br />

1500ml;<br />

2000ml;<br />

2500ml;<br />

5000ml<br />

38,6g+5,7g+<br />

3,9g+257mg+152mg/1000ml<br />

1500ml; 2000ml; 2500ml;<br />

5000ml<br />

13,6g+5,38g+<br />

4,48g+184mg+ 51mg/1000ml<br />

1500ml;<br />

2000ml;<br />

2500ml;<br />

5000ml<br />

22,7g+5,38g+<br />

4,48g+184mg<br />

+51mg/1000ml 1500ml;<br />

2000ml;<br />

2500ml;<br />

5000ml<br />

38,6g+5,38g+<br />

4,48g+184mg+51g/1000ml<br />

1500ml;<br />

2000ml;<br />

2500ml;<br />

5000ml<br />

Herbapol Cracow<br />

Polpharma<br />

Schering<br />

1447. Dianormet Metformini hydrochloridum tab. 850mg N30 Polfa Kutno<br />

Pharmaceutical<br />

Company<br />

1448. Diaprel Gliclazidum tab. 80mg N60 Servier<br />

1449. Diaprel MR Gliclazidum modified-release<br />

tab.<br />

1450. Diazem Diltiazemum tab. 60mg N30; N100 Medochemie<br />

1451. Diazepam Desitin rectal tube<br />

10 mg<br />

1452. Diazepam Desitin rectal tube<br />

5mg<br />

30mg<br />

N60<br />

Baxter<br />

Baxter<br />

Baxter<br />

Baxter<br />

Baxter<br />

Baxter<br />

Servier<br />

Diazepamum rectal sol. 10mg/2,5ml micro-enema N5 Desitin<br />

Diazepamum rectal sol. 5mg/2,5ml micro-enema N5 Desitin


EN<br />

180 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

1453. Diazepam Nycomed Diazepamum sol. for inj. 10mg/2ml N5 Nycomed Austria<br />

1454. Diazepamo<br />

5 mg tablete˙s<br />

1455. Diazepamo<br />

5 mg tablete˙s<br />

1456. Diazepamo<br />

10 mg tablete˙s<br />

1457. Diazepamo 0,5 % tirpalas<br />

injekcijoms<br />

Diazepamum tab. 5mg<br />

N20<br />

Diazepamum tab. 5 mg N10 Liuks<br />

Diazepamum tab. 10 mg 10 Liuks<br />

Endokrininiai<br />

preparatai<br />

Diazepamum sol. for inj. 5mg/ml 2ml, 5ml amp. N10 Endokrininiai<br />

preparatai<br />

1458. Diazepeks Diazepamum tab. 5mg N20; N50 Grindex<br />

1459. Diazepeks 0,5 % škidums<br />

injekcijam<br />

Diazepamum sol. for inj. 10mg/2ml amp. N10; N330 Grindex<br />

1460. Diazolino 0,05g drazˇete˙s Diazolinum drag 0,05 g N20 Liuks<br />

1461. Dibazolio 1 % tirpalas<br />

injekcijoms<br />

Bendazolum sol. for inj. 10mg/ml<br />

1ml amp. N10<br />

1462. Dicetel Pinaverii bromidum film-coated tab. 50mg N20 Solvay Pharma<br />

1463. Diclac Diclofenacum sol. for inj. 75mg/3ml N5 Hexal<br />

1464. Diclac 150 ID Diclofenacum prolongedrelease<br />

tab.<br />

Sanitas<br />

150mg N10; N20; N50; N100 Hexal<br />

1465. Diclac 5 % Gel Diclofenacum gel 5mg/g 50g; 100g Hexal<br />

1466. Diclac 50 Diclofenacum gastro-resistant<br />

tab.<br />

1467. Diclac 75 ID Diclofenacum prolongedrelease<br />

tab.<br />

1468. Diclac retard Diclofenacum prolongedrelease<br />

tab.<br />

50mg<br />

N20; N50; N100<br />

75mg N10; N20; N50; N100 Hexal<br />

100mg<br />

N20; N50<br />

Salutas Pharma/PCI<br />

allpack<br />

Salutas Pharma<br />

1469. Dicloberl 100 Diclofenacum natricum supp. 100mg N5;N10 Berlin-Chemie<br />

1470. Dicloberl 50 Diclofenacum natricum gastro-resistant<br />

tab.<br />

50mg N20;N50; N100 Berlin-Chemie<br />

1471. Dicloberl 50 Diclofenacum natricum supp. 50mg N10 Berlin-Chemie<br />

1472. Dicloberl N 75 Diclofenacum natricum sol. for inj. 75mg/3ml amp. N1;N3; N5 Berlin-Chemie<br />

1473. Dicloberl retard Diclofenacum natricum slow-release<br />

caps.<br />

100mg N20;N50; N100 Berlin-Chemie<br />

1474. Diclofenac Diclofenacum supp. 100mg N10 Polfa Poznan<br />

1475. Diclofenac Diclofenacum supp. 50mg N10 Polfa Poznan<br />

1476. Diclofenac 100 Stada Diclofenacum supp. 100mg<br />

N10<br />

1477. Diclofenac 100 Stada retard Diclofenacum natricum modified-release<br />

tab.<br />

1478. Diclofenac 25 Stada Diclofenacum natricum enteric-coated<br />

tab.<br />

1479. Diclofenac 50 Stada Diclofenacum supp. 50mg<br />

N10<br />

Stada<br />

100mg N20; N50; N100 Stada<br />

25mg N20; N50; N100 Stada<br />

Stada


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 181<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1480. Diclofenac 50 Stada Diclofenacum natricum enteric-coated<br />

tab.<br />

1481. Diclofenac Duo BMS Diclofenacum caps., hard 75mg<br />

N30<br />

1482. Diclofenac retard-ratiopharm<br />

100<br />

Diclofenacum natricum sustainedrelease<br />

caps.<br />

Strength Manufacturer<br />

50mg N20; N50; N100 Stada<br />

Pharmavit<br />

100mg N20 Merckle<br />

1483. Diclofenac-ratiopharm 100 Diclofenacum natricum supp. 100mg N10; N50 Merckle<br />

1484. Diclofenac-ratiopharm 25<br />

Tabletten<br />

Diclofenacum natricum gastro-resistant<br />

tab.<br />

25mg N20 Merckle<br />

1485. Diclofenac-ratiopharm 50 Diclofenacum natricum tab. 50mg N20;N50 Merckle<br />

1486. Diclofenac-ratiopharm 50 Diclofenacum natricum supp. 50mg N10 Merckle<br />

1487. Diclofenac-ratiopharm SF Diclofenacum natricum sol. for inj. 75mg/2ml amp. N10 Merckle<br />

1488. Diclofenac-ratiopharm uno Diclofenacum natricum prolongedrelease<br />

tab.<br />

150mg (25mg rapid-release+<br />

125mg sustained-release) N10<br />

Merckle<br />

1489. Diclofenac-Rivo Diclofenacum tab. 50mg N30 Rivopharm<br />

1490. Diclofenac-Rivo Diclofenacum retard tab. 100mg N30 Rivopharm<br />

1491. Diclomax Diclofenacum natricum sol. for inj. 25mg/ml 3ml amp. N5 Torrent<br />

1492. Diclomax-25 Diclofenacum natricum enteric-coated<br />

tab.<br />

1493. Diclomax-50 Diclofenacum natricum enteric-coated<br />

tab.<br />

1494. Diclomelan Diclofenacum sol. for inj. 75mg/3ml<br />

N5<br />

25mg N100 Torrent<br />

50mg N100 Torrent<br />

Lannacher<br />

1495. Diclomelan Diclofenacum film-coated tab. 50mg N30; N50 Lannacher<br />

1496. Diclomelan 100 mg Diclofenacum supp. 100mg<br />

N6<br />

1497. Diclomelan retard Diclofenacum film-coated tab. 100mg<br />

N30; N50<br />

1498. Diclonac Diclofenacum sol. for inj. i.m. 75mg/3ml N5; N20 Lupin<br />

1499. Dicloran SR Diclofenacum sustainedreleasefilmcoated<br />

tablets<br />

1500. Diclotard 100mg Diclofenacum sustained<br />

release filmcoated<br />

tablets<br />

1501. Diclovit Diclofenacum+Thiaminum+<br />

Pyridoxinum+<br />

Cyanocobalaminum<br />

1502. Dicortineff Neomycinum+<br />

Gramicidinum+<br />

Fludrocortisonum<br />

1503. Dicynone injections<br />

250 mg/2 ml<br />

1504. Dicynone tablets<br />

250 mg<br />

Lannacher<br />

Lannacher<br />

100mg N20,N100 Unique<br />

Pharmaceutical<br />

Laboratories<br />

100mg N20 Terapia S.A.<br />

caps. 50mg+50mg+50mg+<br />

0,25mg<br />

N30<br />

eye/ear drops,<br />

susp.<br />

2,5mg+<br />

0,025mg+<br />

1mg/ml<br />

10ml<br />

Etamsylatum sol. for inj. 250mg/2ml amp. N50 Lek<br />

Etamsylatum tab. 250mg N100 Lek<br />

Lannacher<br />

Polfa Warsaw


EN<br />

182 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

1505. Didzˇiosios ugniazˇole˙s zˇole˙ Herb.Chelidonii herbal tea 50g Švenčioniu˛<br />

vaistazˇole˙s<br />

1506. Dif-Eritropoetinas Erythropoietinum<br />

recombinantum humanum<br />

solution for<br />

injection<br />

2000 UI/ml Endokrininiai<br />

preparatai AB<br />

1507. Differin 0,1 % Cream Adapalenum cream 0,1g/100g 30g Laboratoires<br />

Galderma<br />

1508. Differin 0,1 % Gel Adapalenum gel 0,1g/100g 30g Laboratoires<br />

Galderma<br />

1509. Diflazon Fluconazolum caps. 200mg N7; N20 KRKA<br />

1510. Diflazon Fluconazolum caps. 150mg N1 KRKA<br />

1511. Diflazon Fluconazolum caps. 100mg N28 KRKA<br />

1512. Diflazon Fluconazolum caps. 50mg N7 KRKA<br />

1513. Diflazon Fluconazolum sol. for infusion 2mg/ml 100ml KRKA<br />

1514. Diflucan Fluconazolum caps. 50mg N7 Pfizer<br />

1515. Diflucan Fluconazolum caps. 100mg N7 Pfizer<br />

1516. Diflucan Fluconazolum caps. 150mg N1 Pfizer<br />

1517. Diflucan Fluconazolum sol. for inf. 2mg/ml 50ml;100ml vials Pfizer<br />

1518. Digestive Aid Tablets Silybi mariani fructus<br />

extr.(25:1)+ Taraxaci radix +<br />

Carvi fructus +Menthae folium<br />

+Frangulae cortex<br />

1519. Diges-Tonic Alcoholic tinctura (1:5)<br />

Herb.Hyperici+ Fruct.Silybi<br />

mariani+Flor. Chamomillae+<br />

Fol.Menthae pip.+Rad.Rhei+<br />

Fruct.Rosae+ Fruct.Coriandri+<br />

Fruct.Foeniculi+ Ethanolum<br />

70%<br />

1520. Digoksino<br />

0,25 mg tablete˙s<br />

tab. 7mg+100mg+50mg+60mg+<br />

60mg N20;N60<br />

tinct. 4,7partis+ 3,52partis+<br />

2,54partis+ 2,34partis+<br />

2,36partis+ 2,34partis+<br />

1,2partis+ 1,2partis+ 100partis<br />

35g;100g<br />

Digoxinum tab. 0,25 mg<br />

N40<br />

1521. Digoksino 0,25 mg tablete˙s Digoxinum tab. 0,25mg<br />

N30;N50<br />

1522. Digoxin Digoxinum tab. 0,25mg<br />

N30<br />

Labofarm<br />

Herbapol Cracow<br />

Liuks<br />

Sanitas<br />

Polfa Warsaw<br />

1523. Digoxin Digoxinum tab. 0,25mg N30 Polfa Kutno<br />

1524. Digoxin Alpharma Tablets<br />

250 mcg<br />

Digoxinum tab. 250µg N30 Alpharma<br />

1525. Dihydergot Dihydroergotaminum nasal spray 4mg/ml Sandoz<br />

1526. Dikaino<br />

0,25 % tirpalas — akiu˛ lašai<br />

1527. Dikaino 1 % tirpalas — akiu˛<br />

lašai<br />

1528. Diklofenako<br />

25 mg tablete˙s<br />

1529. Diklofenako<br />

50 mg tablete˙s<br />

Tetracainum eye drops, sol. 2,5mg/ml 1,5ml amp. N10;<br />

5ml bottle N1<br />

Endokrininiai<br />

preparatai<br />

Tetracainum eye drops 10mg/ml 1,5ml; 5ml Endokrininiai<br />

preparatai<br />

Diclofenacum tab. 25 mg N20; N30; N50 Liuks<br />

Diclofenacum tab. 50 mg N20; N30; N50 Liuks


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 183<br />

No. Commercial name General name<br />

1530. Diklofenako natrio 75 mg<br />

(25 mg/ml) tirpalas injekcijoms<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

Diclofenacum natricum sol.for inj. 75mg/3ml amp. N100 Pharmamed/Ilsanta<br />

1531. Diklonat P Diclofenacum natricum sol. for inj. 75mg/3ml amp. N5 Pliva<br />

1532. Diklonat P 50 Diclofenacum natricum supp. 50mg<br />

N10<br />

1533. Diklonat P retard 100 Diclofenacum natricum film-coated<br />

prolongedrelease<br />

tab.<br />

100mg<br />

N20<br />

1534. Dilatrend 12,5 Carvedilolum tab. 12,5mg N30 Roche Diagnostics<br />

1535. Dilatrend 25 Carvedilolum tab. 25mg N30 Roche Diagnostics<br />

1536. Dilatrend 6,25 Carvedilolum tab. 6,25mg N30 Roche Diagnostics<br />

1537. Dilceren Nimodipinum coated tab. 30mg N50 Slovakofarma<br />

1538. Dilceren pro infusione Nimodipinum sol.for inf. 10mg/50ml 50ml Slovakofarma<br />

1539. Dilge˙le˙s lapai Fol.Urticae herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

1540. Dilge˙liu˛ lapai (smulkinti) Folium Urticae herbal tea 50g (2g×25); 50g; 100g; 16,8g<br />

(0,7g×24); 24g (1g×24); 36g<br />

(1,5g×24); 48g (2g×24).<br />

1541. Dilrene Diltiazemum sustainedrelease<br />

caps.<br />

1542. Diltiazem Lannacher Diltiazemum retard filmcoated<br />

tab.<br />

1543. Diltiazem Lannacher Diltiazemum retard filmcoated<br />

tab.<br />

1544. Diltiazem tablete˙s<br />

60 mg<br />

1545. Diltiazem tablete˙s<br />

90 mg<br />

300mg<br />

N28<br />

90mg<br />

N20;N50<br />

180mg<br />

N30<br />

Diltiazemum tab. 60mg<br />

N30<br />

Diltiazemum tab. 90mg<br />

N30<br />

1546. Diltiazemo 60 mg tablete˙s Diltiazemum tab. 60 mg N30; N50; N60; N100 Liuks<br />

1547. Diltisan Diltiazemum tab. 60mg<br />

N100<br />

1548. Dilzem<br />

180 mg retard<br />

Diltiazemum prolongedrelease<br />

tab.<br />

1549. Dilzem 25 mg parenteral Diltiazemum powder and<br />

solvent for sol.<br />

for inj.<br />

Pliva<br />

Pliva<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Sanofi Winthrop<br />

Lannacher<br />

Lannacher<br />

Pliva<br />

Pliva<br />

Sanofi Winthrop<br />

180mg N30 Gödecke<br />

25mg/bottle+<br />

5ml amp. of solvent N5<br />

Gödecke<br />

1550. Dilzem 60 mg Diltiazemum tab. 60mg N30 Gödecke<br />

1551. Dilzem 90 mg retard Diltiazemum sustainedrelease<br />

tab.<br />

90mg<br />

N30<br />

1552. Dilzem Once Daily Diltiazemum depot caps. 240mg<br />

N28<br />

1553. Dilzem Once Daily Diltiazemum depot caps. 120mg<br />

N28<br />

1554. Dilzem Once Daily Diltiazemum depot caps. 180mg<br />

N28<br />

Gödecke<br />

Elan/<br />

Nycomed<br />

Elan/<br />

Nycomed<br />

Elan/<br />

Nycomed


EN<br />

184 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1555. Dimedrol Diphenhydraminum tab. 50mg<br />

N10<br />

1556. Dimedrol Diphenhydraminum sol. for inj. 10mg/ml<br />

N10<br />

1557. Dimedrolio 1% tirpalas<br />

injekcijoms<br />

Diphenhydraminum sol. for inj./inf. 10mg/ml<br />

1ml amp.<br />

N10<br />

Strength Manufacturer<br />

1558. Dimedrolio tablete˙s Diphenhydraminum tab. 0,05 N10 Liuks<br />

1559. Dimexidum (dimethylsulfoxidum)<br />

sol.<br />

Dimethylsulfoxidum sol. 100ml Liuks<br />

1560. Diovan Valsartanum caps. 160mg<br />

N28<br />

1561. Diovan Valsartanum caps. 80mg<br />

N28<br />

1562. Diovan 160 Valsartanum film-coated tab. 160mg<br />

N14<br />

1563. Diovan 80 Valsartanum film-coated tab. 80mg<br />

N14<br />

1564. Dioxydinum sol. pro inj. 1%<br />

10ml<br />

Dioxidinum sol. 1%-10ml N10 Liuks<br />

1565. Dipeptiven N(2)-L-alanyl-L-glutaminum conc. for sol.<br />

for inf.<br />

1566. Diphereline<br />

0,1 mg<br />

Triptorelinum powder and<br />

solvent for<br />

sol.for inj.<br />

1567. Diphereline 3,75 mg Triptorelinum powder and<br />

solvent for<br />

susp. for i.m.<br />

inj., formulation<br />

for sustainedrelease<br />

1568. Diphereline S.R.<br />

11,25 mg<br />

Triptorelinum powder and<br />

solvent for<br />

susp. for inj.<br />

sustainedrelease<br />

form<br />

Tallinna<br />

Farmaatsiatehase<br />

Tallinna<br />

Farmaatsiatehase<br />

Endokrininiai<br />

preparatai<br />

Ciba-Geigy<br />

Ciba-Geigy<br />

Novartis Pharma<br />

Novartis Pharma<br />

20g/100ml 50ml; 100ml Fresenius Kabi<br />

0,1mg/vial+<br />

1ml amp. of solvent (Sodium<br />

chloride 9mg<br />

+water for inj. 1ml) N7<br />

3,75mg<br />

N1 (bottle, amp., syringe and 2<br />

needles)<br />

11,25mg/ vial (2ml amp. of<br />

reconstitution sol.) N1<br />

1569. Dipidolor Piritramidum sol. for inj. 7,5mg/ml 2ml amp. N5 Janssen<br />

1570. Diprivan 1 % Propofolum emulsion for<br />

i.v. inj.<br />

10mg/ml 20ml amp. N5; 50ml<br />

vials N1<br />

Pharma Biotech<br />

Pharma Biotech<br />

Pharma Biotech<br />

Pharmacia &<br />

Upjohn/AstraZeneca<br />

1571. Diroton Lisinoprilum tab. 5mg N28 Gedeon Richter<br />

1572. Diroton Lisinoprilum tab. 10mg N28 Gedeon Richter<br />

1573. Diroton Lisinoprilum tab. 20mg N28 Gedeon Richter<br />

1574. Dirvinio asiūklio zˇole˙ Herb. Equiseti arvensis herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

1575. Dirvinio asiūklio zˇole˙<br />

(smulkinta)<br />

Herba Equiseti arvensis herbal tea 100g; 50g; 50g (2g×25) Švenčioniu˛<br />

vaistazˇole˙s<br />

1576. Disflatyl Simeticonum chewable tab. 40mg N30;N100 Solco Basel


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 185<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1577. Disflatyl Simeticonum oral drops,<br />

emuls.<br />

1578. Dispersible Aspirin tablets BP<br />

300 mg<br />

1579. Ditec Fenoterolum+Natrii<br />

cromoglicas<br />

Strength Manufacturer<br />

40mg/ml 30ml Solco Basel<br />

Acidum acetylsalicylicum tab. 300mg N30;N500 Cox<br />

metered dose<br />

inhaler<br />

1580. Diuretic (Diuretikas) Ol.Juniperi caps., soft 110mg<br />

N40<br />

0,05mg+1mg/dose 10ml Boehringer<br />

Ingelheim<br />

1581. Divigel Estradiolum gel 0,1% 1mg/dose N28 Orion<br />

1582. Divigel Estradiolum gel 0,1% 0,5mg/dose N28; N91 Orion<br />

1583. Diviseq White tab.:Estradioli valeras;<br />

Blue tab.: Estradioli valeras+<br />

Medroxyprogesteronum; Pink<br />

tab.: Estradioli valeras<br />

1584. Divitren Estradioli valeras; Estradioli<br />

valeras+ Medroxyprogesteronum;<br />

Placebo<br />

1585. Dobuject Dobutaminum conc. for sol.<br />

for inf.<br />

1586. Dobutamin Nycomed Dobutaminum conc. for sol.<br />

for inf.<br />

1587. Dobutamin Nycomed Dobutaminum powder for sol.<br />

for inf.<br />

tab. 2mg; 2mg+ 10mg; 1mg N28;<br />

N84<br />

Arco-Chemie<br />

Orion<br />

tab. 2mg; 2mg+20mg N91 Orion<br />

50mg/ml<br />

5ml amp. N 5<br />

Leiras<br />

12,5mg/ml 20ml amp. N10 Nycomed Austria<br />

250mg N10 Nycomed Austria<br />

1588. Doksiciklino hidrochloridas Doxycyclinum caps. 0,1 g N10 Liuks<br />

1589. Dolal Phenylpropyl -salicylas+Ethyl -<br />

methoxysalicylas<br />

liniment 50g+ 10g/100g 20g Biocodex<br />

1590. Dolgit Cream Ibuprofenum cream 5g/100g 50g Dolorgiet<br />

1591. Dolmen Dexketoprofenum film-coated tab. 25mg<br />

N10; N30; N50<br />

1592. Dolobene Gel Heparinum natricum+<br />

Dimethylis sulfoxidum+<br />

Dexpanthenolum<br />

gel 500IU+ 150mg+ 25mg/g 20g;<br />

50g<br />

Laboratorios<br />

Menarini/<br />

Menarini Industria<br />

SUD<br />

1593. Dolobid Diflunisalum tab. 500mg N20 Merck<br />

Manufacturing<br />

Division-Haarlem<br />

1594. Dolsin inj. Pethidinum sol. for inj. 50mg/ml<br />

amp. N10<br />

Mepha<br />

Hoechst Biotika<br />

1595. Dolsin inj. Pethidinum sol. for inj 100mg/2ml amp. N10 Hoechst Biotika<br />

1596. Doltard<br />

30 mg<br />

1597. Doltard<br />

60 mg<br />

Morphini sulfas sustainedrelease<br />

tab.<br />

Morphini sulfas sustainedrelease<br />

tab.<br />

30mg<br />

N20<br />

60mg<br />

N20<br />

Nycomed Danmark<br />

Nycomed Danmark<br />

1598. Domstal Domperidonum tablets 10mg N100 Torrent<br />

Pharmaceuticals Ltd.<br />

1599. Dopa — Merz Levodopum+ Benserazidum tab. 100mg+25mg N30; N90 Rottendorf Pharma


EN<br />

186 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1600. Dopamin Solvay 200 Dopamini hydrochloridum conc. for sol.<br />

for. inf.<br />

Strength Manufacturer<br />

200mg/10ml amp. N5 Solvay<br />

Pharmaceuticals<br />

1601. Dopamine hydrochloride 1 % Dopamini hydrochloridum sol. for inf. 10mg/ml 5ml amp. N10 Polfa Warsaw<br />

1602. Dopamine hydrochloride 4 % Dopamini hydrochloridum sol. for inf. 40mg/ml 5ml amp. N10 Polfa Warsaw<br />

1603. Dopegyt Methyldophum tab. 250mg N50 Egis<br />

1604. Dormicum Midazolamum tab. 7,5mg<br />

N10<br />

1605. Dormicum Midazolamum sol. for inj. 5mg/ml<br />

1ml amp.N10<br />

1606. Dormiplant Extr.rad.Valerianae siccum<br />

(4,5:1)+ Extr.fol.Melissae<br />

siccum (4-6:1)<br />

sugar-coated<br />

tab.<br />

1607. Dosiseptine Chlorhexidinum solution for<br />

local<br />

application,<br />

spray<br />

1608. Dosiseptine Chlorhexidinum sol. for local<br />

application<br />

1609. Dosoxygenee Hydrogenii peroxidum cutaneous<br />

solution<br />

160mg+ 80mg<br />

N50; N100<br />

1610. Dostinex Cabergolinum tab. 0,5mg<br />

N2; N4; N8<br />

Roche<br />

Roche<br />

50mg/100ml 50ml Gifrer<br />

50mg/100ml 5ml;15ml; 25ml;<br />

45ml; 100ml<br />

3g/100ml 5ml;10ml; 15ml;<br />

45ml; 100ml<br />

1611. Dotur Doxycyclinum caps. 100mg N6; N10 Biochemie<br />

Dr.Willmar Schwabe<br />

Gifrer<br />

Gifrer<br />

Pharmacia & Upjohn<br />

1612. Doxepin Doxepinum caps. 25mg N30 Pliva Krakow<br />

1613. Doxepin Doxepinum caps. 10mg<br />

N30<br />

Pliva Krakow<br />

1614. Doxitin Doxycyclinum tab. 100mg N8; N10; N100 Vitabalans<br />

1615. Doxitin Doxycyclinum tab. 150mg N8; N10; N100 Vitabalans<br />

1616. Doxolem RU 10 mg Doxorubicinum sol. for inj. 10mg/5ml vial N1 Lemery<br />

1617. Doxolem RU 50 mg Doxorubicinum sol. for inj. 50mg/25ml vial N1 Lemery<br />

1618. Doxorubicin Doxorubicinum powder for sol.<br />

for inj.<br />

1619. Doxorubicin Doxorubicinum powder for sol.<br />

for inj.<br />

1620. Doxorubicin ‘Ebewe’<br />

10 mg<br />

1621. Doxorubicin ‘Ebewe’<br />

50 mg<br />

Doxorubicinum concentrate for<br />

sol.for inf.<br />

Doxorubicinum concentrate for<br />

sol.for inf.<br />

1622. Doxorubicin Hydrochloride Doxorubicinum powder for sol.<br />

for inj.<br />

1623. Doxorubicin Hydrochloride Doxorubicinum powder for sol.<br />

for inj.<br />

10mg N1 Abic<br />

50mg N1 Abic<br />

10mg/5ml vial N1 Ebewe<br />

50mg/25ml vial N1 Ebewe<br />

50mg/vial N1 Faulding<br />

10mg/vial N1 Faulding


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 187<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1624. Doxy M-ratiopharm 100 Doxycyclinum tab. 100mg<br />

N10<br />

Strength Manufacturer<br />

Merckle<br />

1625. Doxycyclin Doxycyclinum sol. for inf. 100mg/5ml vial N10 Polfa Tarchomin<br />

1626. Doxycyclin Doxycyclinum caps. 100mg<br />

N10<br />

Polfa Tarchomin<br />

1627. Doxycyclin Doxycyclinum caps. 100mg N6 Balkanpharma-<br />

Razgrad<br />

1628. Doxycyclin 100 Stada Tabs Doxycyclinum tab. 100mg N10;N20 Stada<br />

1629. Doxycyclin 200 Stada Tabs Doxycyclinum tab. 200mg N10 Stada<br />

1630. Doxycycline Doxycyclinum caps. 100mg N8 Norton<br />

1631. Doxycycline Doxycyclinum caps. 50mg N26 Norton<br />

1632. Doxycycline-Rivo Doxycyclinum tab. 100mg N8; N10; N30 Rivopharm<br />

1633. Doxyhexal Doxycyclinum tab. 100mg N10;N20 Hexal<br />

1634. DPT Vaccine Behring Diphtheria toxoid, absorbed+<br />

Bordetella pertussis<br />

inactivated+ Tetanus toxoid<br />

absorbed<br />

susp. for inj. > or =30IU+> or =4IU+> or<br />

=40IU/0,5 ml<br />

Chiron Behring<br />

1635. Dr. Theiss Nose Spray Xylometazolinum nasal spray, sol. 1mg/ml 10ml Naturwaren<br />

1636. Dr. Theiss Venen Gel Horse chestnut extract+<br />

Calendula extract<br />

gel 3g+0,4g/100g Naturwaren<br />

1637. Dr.Theiss Anisol Kapseln Anise oil capsules 100mg N30 Naturwaren OHG<br />

Dr.Peter Theiss<br />

1638. Dr.Theiss Arnica Salbe Arnicae tinctura ointment 5g/100g 50g Naturwaren<br />

1639. Dr.Theiss Echinacea Forte Echinacea purpurea (1,5-2,5:1) oral drops 75,6ml/<br />

100ml (Ethanolum 90 tūrio %<br />

24,4ml/<br />

100ml) 50ml<br />

1640. Dr.Theiss Eucalyptus<br />

Erkaltungsbalsam-S<br />

1641. Dr.Theiss Gerovital<br />

Effervescent Tablets<br />

Eucalypti aetheroleum+ Pini<br />

aetheroleum+ Camphora<br />

racemica<br />

Ferrosi lactas+ Retinolum+<br />

Colecalciferolum+<br />

Thiaminum+ Pyridoxinum+<br />

Riboflavinum+ Acidum<br />

ascorbicum+ Tocopherolum+<br />

Nicotinamidum+ Calcii<br />

pantothenas+<br />

Cyanocobalaminum+Extr.<br />

Crataegi fructus+Extr. Crataegi<br />

folium et flores<br />

1642. Dr.Theiss Grippetrophen Ferrum phosphoricum D8+<br />

Gelsemium D6+ Baptisa D4+<br />

Eupatorium perfoliatum D4+<br />

Aconitum D6<br />

Naturwaren<br />

ointment 7,5g+7,5g+5g/100g 50g Naturwaren<br />

efferv.tab. 3,75mg+ 217IU+ 73IU+<br />

0,9mg+ 1,35mg+ 1,35mg+<br />

67,5mg+ 9mg+ 11,25mg+<br />

6mg+ 1,67µg+ 16mg+ 4mg<br />

N10; N20<br />

drops 20g+20g+ 20g+20g+<br />

20g/100g 30ml<br />

Naturwaren<br />

Naturwaren OHG<br />

Dr.Peter Theiss


EN<br />

188 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

1643. Dr.Theiss Multivitamol<br />

Effervescent Tablets<br />

Ferrosi lactas+ Retinolum+<br />

Colecalciferolum+<br />

Thiaminum+ Pyridoxinum+<br />

Riboflavinum+ Acidum<br />

ascorbicum+ Tocopherolum+<br />

Nicotinamidum+ Calcii<br />

pantothenas+<br />

Cyanocobalaminum<br />

1644. Dr.Theiss Rheuma Cre˙me Capsicain+<br />

Swedish Bitters: Aloe+<br />

Rhubarb roots+ Theriak<br />

venez.+ Myrrh+ Angelica<br />

roots+ Camphor+ Senna<br />

leaves+ Saffron+ Manna and<br />

Capsicain<br />

1645. Dr.Theiss Spitzwegerich<br />

Hustensaft<br />

1646. Driptane<br />

5mg<br />

1647. Droperidolio 0,25% tirpalas<br />

injekcijoms<br />

1648. Droperidols 0,25 % škidums<br />

injekcijam<br />

1649. Droperidols 0,25 % škidums<br />

injekcijam<br />

Plantaginis lanceolate herbae<br />

extractum fluidum (1:1)<br />

Pharmaceutical<br />

form<br />

Oxybutyninum scored tab. 5mg<br />

N60<br />

Droperidolum solution for<br />

injection<br />

Strength Manufacturer<br />

efferv. tab. 1,5mg+ 27IU+ 45IU+ 0,6mg+<br />

0,75mg+ 0,75mg+ 45mg+<br />

4,5mg+ 7,5mg+ 3,75mg+<br />

0,375µg N10; N20<br />

cream 25mg+6g: 40mg+40mg+<br />

40mg+ 20mg+40mg+40mg+<br />

20mg+10mg+40mg+ 0,8mg+<br />

70mg/100g 30ml; 70ml<br />

Droperidolum sol. for inj. 5mg/2ml<br />

N10<br />

1650. Drosera-Homaccord Drosera D2+ Drosera D10+<br />

Drosera D30+ Drosera D200+<br />

Cuprum aceticum D4+Cuprum<br />

aceticum D10+ Cuprum<br />

aceticum D30+Cuprum<br />

aceticum D200 Ethanolum<br />

35 %<br />

Naturwaren<br />

Naturwaren<br />

syrup 5g/100g 100ml Naturwaren<br />

Laboratoires<br />

Fournier<br />

0,25% 2ml amp. N10 Endokrininiai<br />

preparatai AB<br />

Grindex<br />

Droperidolum sol. for inj. 12,5mg/5ml N10 Grindex<br />

drops 0,5g+0,5g+ 0,5g+0,5g+ 0,5g+<br />

0,5g+ 0,5g+ 0,5g/100g 30ml;<br />

100ml<br />

1651. Drotaverino tablete˙s Drotaverinum tab. 40 mg N20 Liuks<br />

1652. Dujinis medicininis deguonis Oxygenium gas 99,5% 40l (6,3 m 3 ) baloonse Kriogenas<br />

1653. Duodenoheel Semecarpus anacardium D4 +<br />

Argentum nitricum D6+<br />

Ipecacuanha D4+ Jodum D6+<br />

Lachesis mutus D12+<br />

Petroleum rectificatum D6 +<br />

Robinia pseudoacacia D4<br />

1654. Duofilm Acidum lacticum +Acidum<br />

salicylicum<br />

1655. Duo-Septol 120 Sulfamethoxazolum+<br />

Trimethoprimum<br />

1656. Duo-Septol 480 Sulfamethoxazolum+<br />

Trimethoprimum<br />

1657. Duovit raudona tablete˙: Retinolum+<br />

Colecalciferolum+ Acidum<br />

ascorbicum+Nicotinamidum+<br />

Tocopherolum+Calcii<br />

pantothenas+ Pyridoxinum+<br />

Riboflavinum+ Thiamini nitras<br />

+Acidum folicum +<br />

Cyanocobalaminum; me˙lyna<br />

tablete˙: Magnesium+Calcium+<br />

Phosphorus+etc<br />

tab. 30mg+30mg+30mg+ 30mg+<br />

60mg+60mg+ 60mg<br />

N50<br />

topical sol. 16,7%+ 16,7%<br />

15ml<br />

Heel<br />

Heel<br />

Stiefel Laboratories<br />

tab. 100mg+20mg N20 ICN Polfa Rzeszow<br />

tab. 400mg+80mg N20 ICN Polfa Rzeszow<br />

coated tab. red tab.:5 000 UI + 200 UI+<br />

60mg+13mg+ 10mg+5mg+<br />

2mg+1,2mg+1mg+0,4mg+<br />

3µg; blue tab.:20mg+ 15mg+<br />

12mg+10mg+3mg+1mg+<br />

1mg+0,1mg<br />

N40<br />

KRKA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 189<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1658. Duphalac Lactulosum powder for oral<br />

administration<br />

10g/sachet<br />

N10<br />

Strength Manufacturer<br />

Solvay<br />

Pharmaceuticals<br />

1659. Duphalac Lactulosum oral sol. 667g/l 200ml; 500ml; 1000ml Solvay<br />

Pharmaceuticals<br />

1660. Duphaston Dydrogesteronum film-coated tab. 10mg<br />

N20<br />

1661. Duracef Cefadroxilum powder for oral<br />

susp.<br />

1662. Duracef Cefadroxilum caps. 250mg<br />

N50<br />

1663. Duracef Cefadroxilum caps. 500mg<br />

N100<br />

1664. Duracef Cefadroxilum dispersible tab. 1g<br />

N10<br />

1665. Duratears Ol.Vaselini+Lanolini liquidum<br />

anhydricum +Vaselinum album<br />

1666. Durogesic<br />

25 µg/h<br />

1667. Durogesic<br />

50 µg/h<br />

1668. Durogesic<br />

75 µg/h<br />

Fentanylum transdermal<br />

patch<br />

Fentanylum transdermal<br />

patch<br />

Fentanylum transdermal<br />

patch<br />

1669. Durogesic 100 µg/h Fentanylum transdermal<br />

patch<br />

1670. Dynastat Parecoxib powder for<br />

solution for<br />

injection<br />

1671. Dysmenorm Agnus castus O + Pulsatilla<br />

D3+ Rosmarinus officinalis<br />

D2+ Apis mellifica D3<br />

1672. Dysport Clostridium botulinum type A<br />

toxin- haemagglutinin complex<br />

eye ointment 30mg+30mg+<br />

1g/3,5g<br />

Solvay<br />

Pharmaceuticals<br />

250mg/5ml 60ml Bristol-Myers Squibb<br />

25µg/h (2,5mg/10cm 2 ) N5 Janssen<br />

50µg/h (5mg/20cm 2 ) N5 Janssen<br />

75µg/h (7,5mg/30cm 2 ) N5 Janssen<br />

100µg/h (10mg/40cm 2 ) N5 Janssen<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Alcon-Couvreur<br />

20mg 2ml vial N10 Pharmacia Limited/<br />

Wasserburger<br />

Arzneimittelwerk,<br />

Dr.Madaus GmbH/<br />

Ben Venue<br />

Laboratories/Searle<br />

Ltd/Lancaster<br />

Laboratories/<br />

Teleplan/Wickham<br />

Laboratories. Ltd./<br />

Labor L+S GmbH<br />

tab. 125mg+ 25mg+ 25mg+ 25mg<br />

N80;N100; N200<br />

powder for inj. 500U/vial<br />

N1; N2<br />

1673. Eau Oxygenee Gifrer Hydrogenii peroxidum cutaneous<br />

spray, solution<br />

1674. Echan Succus ex herb. et flor.<br />

Echinacea purpurea<br />

(Ethanolum 22%)<br />

DHU<br />

3g/100ml 125ml Gifrer<br />

Ipsen Biopharm<br />

sol. 75,6ml 50ml; 100ml; 150ml Biocur Arzneimittel


EN<br />

190 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

1675. Echinacea compositum<br />

Cosmoplex<br />

Echinacea angustifolia D2+<br />

Lachesis mutus D10+Hepar<br />

sulfuris D8+ Phytolacca<br />

americana D4+ Thuja<br />

occidentalis D4+Bryonia<br />

cretica D4+ Chamomilla<br />

recutita D6+Rhus<br />

toxicodendron D4<br />

1676. Echinafitas Extractum Echinaceae pallidae<br />

e radice siccum+Extractum<br />

Uncariae tomentosae e cortex<br />

siccum+ Extractum Echinaceae<br />

e herba siccum+ Myrtol<br />

1677. Echinasal Extr. fluidum ex Fol.<br />

Plantaginis lanc., herb.<br />

Grindeliae, fruct. Rosae<br />

(3:1:1)+ Extr. Thymi fluidum+<br />

Succus Echinacea<br />

1678. Ecobec<br />

100 µg<br />

1679. Ecobec<br />

100 µg Easi-Breathe<br />

1680. Ecobec<br />

250 µg<br />

1681. Ecobec<br />

250 µg Easi-Breathe<br />

1682. Ecobec 100mcg Easi-Breathe<br />

Trio<br />

1683. Ecobec 250mcg Easi-Breathe<br />

Trio<br />

Pharmaceutical<br />

form<br />

Beclometasonum pressurised<br />

inhalation, susp.<br />

Beclometasonum pressurised<br />

inhalation, susp.<br />

Beclometasonum pressurised<br />

inhalation, susp.<br />

Beclometasonum pressurised<br />

inhalation, susp.<br />

Beclomethasonum metered dose<br />

inhaler<br />

Beclomethasonum metered dose<br />

inhaler<br />

tab. 0,9mg+ 0,3mg+ 0,3mg+<br />

0,3mg+ 0,3mg+ 0,3mg+<br />

0,3mg+ 0,3mg N50; N250<br />

Strength Manufacturer<br />

caps.,soft 80mg+ 100mg+ 20mg+ 40mg<br />

N30<br />

syrup 5g+3g+2g/<br />

100g<br />

125ml; 150ml<br />

Heel<br />

Arco-Chemie<br />

Herbapol Wroclaw<br />

100µg/dose 200 doziu˛ Norton/ IVAX-CR<br />

100µg/doze˙je 200 doses;<br />

3×200 doses<br />

Norton/ IVAX-CR<br />

250µg/dose 200 doses Norton/ IVAX-CR<br />

250µg/dose 200 doses; 3×200<br />

doses<br />

Norton/ IVAX-CR<br />

100mcg/dose 3×200 doses Galena a.s. /Norton<br />

(Waterford) Limited<br />

250mcg/dose 3×200 doses Galena a.s. /Norton<br />

(Waterford) Limited<br />

1684. Ecomi Econazolum supp. vag. 150mg N6 Geymonat<br />

1685. Ecomi Econazolum cream 300mg/30g 30g Geymonat<br />

1686. Ecosal Salbutamolum metered dose<br />

aerosol inhaler<br />

1687. Ecosal Easi-Breathe Salbutamolum pressurised<br />

inhalation<br />

1688. Edicin Vancomycinum powder for sol.<br />

for inj.<br />

1689. Edicin Vancomycinum powder for sol.<br />

for inj.<br />

0,1mg/dose 200 doses Norton/ IVAX-CR<br />

0,1mg/dose 200 doses; 3×200<br />

doses<br />

1g/vial N1;N10 Lek<br />

500mg/vial N1; N10 Lek<br />

Norton/ IVAX-CR<br />

1690. Ednyt 10 mg Enalaprilum tab. 10mg N28; N30 Gedeon Richter<br />

1691. Ednyt 2,5 mg Enalaprilum tab. 2,5mg N28; N30 Gedeon Richter<br />

1692. Ednyt 20 mg Enalaprilum tab. 20mg N28; N30 Gedeon Richter<br />

1693. Ednyt 5 mg Enalaprilum tab. 5mg N28; N30 Gedeon Richter<br />

1694. Edronax Reboxetinum tab. 4mg N20; N60 Pharmacia & Upjohn<br />

1695. Efektas Inhaliatorius nuo<br />

slogos<br />

Mentholum+ Camphora+<br />

Methyli salicylas + Pini<br />

aetheroleum+ Menthae pip.<br />

aetheroleum<br />

inhalator 381mg+ 381mg+ 106mg+<br />

950mg+ 15mg/g (Ethanolum<br />

95% 16mg/g) N1<br />

Hasco-Lek


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 191<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

1696. Efexor Venlafaxinum tab. 37,5mg N28 John Wyeth &<br />

Brother<br />

1697. Efexor Venlafaxinum tab. 50mg N42 John Wyeth &<br />

Brother<br />

1698. Efexor Venlafaxinum tab. 75mg N28 John Wyeth &<br />

Brother<br />

1699. Efexor XR Venlafaxinum caps. 37,5mg<br />

N30; N60<br />

1700. Efexor XR<br />

75 mg<br />

Wyeth Medica<br />

Venlafaxinum caps. 75mg N14; N28; N98 Wyeth Medica<br />

1701. Efexor XR 150 mg Venlafaxinum caps. 150mg N14; N28; N98 Wyeth Medica<br />

1702. Efferalgan Paracetamolum efferv. tab. 500mg N16 UPSA<br />

1703. Efferalgan Paracetamolum infants supp. 80mg N10 UPSA<br />

1704. Efferalgan Paracetamolum young children<br />

supp.<br />

150mg<br />

N10<br />

1705. Efferalgan Paracetamolum children supp. 300mg N10 UPSA<br />

1706. Efferalgan Paracetamolum tablets 500mg N16 UPSA<br />

1707. Efferalgan Codeine Paracetamolum+ Codeini<br />

phosphas hemihydricus<br />

1708. Efferalgan Codeine Paracetamolum+ Codeini<br />

phosphas hemihydricus<br />

1709. Efferalgan Comfort Paracetamolum+<br />

Diphenhydramini citras<br />

efferv. tab. 500mg+ 30mg N8; N16; N40;<br />

N100<br />

UPSA<br />

UPSA<br />

film-coated tab. 500mg+ 30mg N8; N16 UPSA<br />

tab. 500mg+38mg N6; N12 UPSA<br />

1710. Efferalgan Extra Paracetamolum+ Coffeinum coated caplets 500mg+65mg N6; N12; N24 UPSA<br />

1711. Efferalgan peroralinis tirpalas<br />

vaikams<br />

1712. Efferalgan su vitaminu C Paracetamolum+ Acidum<br />

ascorbicum<br />

1713. Efisol Dequalinii chloridum+Acidum<br />

ascorbicum<br />

Paracetamolum oral sol. 30mg/ml 90ml UPSA<br />

eff. tablet 330mg+ 200mg<br />

N10; N20<br />

1714. Efloran Metronidazolum tab. 400mg<br />

N10<br />

UPSA<br />

tab. 0,25mg+ 30mg N20 Balkanpharma-<br />

Dupnitza<br />

1715. Efloran Metronidazolum sol. for inf. 500mg/100ml 100ml KRKA<br />

1716. Eglonyl Sulpiridum sol.for inj. 100mg/2ml amp. N6 Synthelabo<br />

1717. Eglonyl Sulpiridum scored tab. 200mg N12; N60 Synthelabo<br />

1718. Ehrlich Balsam Joint & Muscle<br />

Balsam<br />

Eucalypti aetheroleum+<br />

Camphora+ Mentholum+<br />

Benzylis nicotinas+ Capsicum<br />

extr.<br />

ointment 18mg+ 1mg+1mg+10mg+<br />

5mg/g 75ml<br />

KRKA<br />

Ehrlich Pharma<br />

1719. Eifilins Aminophyllinum subst. 0,8-1,5kg;15kg OlainFarm<br />

1720. Eifilins<br />

150 mg<br />

Aminophyllinum tab. 150mg<br />

N30<br />

OlainFarm


EN<br />

192 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

1721. Ekstraktas ‘Trejos devynerios’ Populi gemmae +Capsici<br />

fructus+Caryophylli flores+<br />

Quercus cortex+Calendulae<br />

flores+Lauri folia+Menthae<br />

folia+Anethi fructus+Crataegi<br />

fructus+Artemisiae absinthii<br />

herba+Piperis aromatici<br />

fructus+Levistici radices+<br />

Valerianae rhizomata cum<br />

radicibus +Lupuli. . .<br />

Pharmaceutical<br />

form<br />

extr. 0,5g+0,3g+ 5g+2g+2g+ 5g+<br />

2g+2g+ 2g+2g+2g+ 2g+2g+<br />

2g. . .100ml; 200ml; 500ml;<br />

20l; 25l<br />

Strength Manufacturer<br />

Pharmcos /Sanitas<br />

1722. Elantan 20 Isosorbidi mononitras tab. 20mg N50 Schwarz Pharma<br />

1723. Elantan 40 Isosorbidi mononitras tab. 40mg N50 Schwarz Pharma<br />

1724. Elantan long Isosorbidi mononitras sustainedrelease<br />

caps.<br />

50mg N20 Schwarz Pharma<br />

1725. Eldepryl Selegilinum tab. 5mg N30; N100 Orion<br />

1726. Elenium Chlordiazepoxidum drag. 10mg<br />

N50<br />

1727. Eleuterokoku˛ skystasis<br />

ekstraktas<br />

1728. Eleuterokoku˛ skystasis<br />

ekstraktas 1:1<br />

Eleutherococci extractum<br />

fluidum+ Ethanolum 40 %<br />

(V/V) (1:1)<br />

Eleutherococci extractum<br />

fluidum<br />

1729. Elevit Pronatal Multivitamins film-coated<br />

tablets<br />

extr. (1:1)<br />

5 0ml<br />

exstr. 1000g (Ethanolum 40 % ad 1l)<br />

40ml; 50ml<br />

Polfa Tarchomin<br />

Sanitas<br />

KMU vaistine˙<br />

N30;N100 Roche Products Ltd./<br />

A.Roche Consumer<br />

Health PP Products<br />

Askit Laboratories<br />

1730. Elidel 1% Pimecrolimus cream 1% 15g Novartis Pharma<br />

GmbH<br />

1731. Elitan Metoclopramidum sol. for inj. 5mg/ml 2ml amp. N5; N10;<br />

N100<br />

1732. Elmetacin Indometacinum topical spray,<br />

sol.<br />

1733. Eloxatin Oxaliplatinum powder for sol.<br />

for inf.<br />

1734. Eloxatin Oxaliplatinum powder for sol.<br />

for inf.<br />

1735. Eltroxin Thyroxinum natricum<br />

(Levothyroxinum natricum)<br />

1736. Eltroxin Thyroxinum natricum<br />

(Levothyroxinum natricum)<br />

1737. Eluate of sodium<br />

pertechnetate-99mTc from<br />

isotope generator<br />

99Mo/99mTc<br />

Sodium pertechnetate<br />

Na99mTcO4 (diagnostic)<br />

Medochemie<br />

10mg/ml 50ml;100ml Sankyo<br />

50mg/vial<br />

N1<br />

tab. 100µg<br />

N25; N50; N100<br />

tab. 50µg<br />

N25; N50; N100<br />

Thissen / Sanofi<br />

Winthrop<br />

100mg/vial N1 Thissen / Sanofi<br />

Winthrop<br />

Glaxo<br />

Glaxo<br />

diagnostic agent 0,25-7,5 GBq/ml Polatom<br />

1738. Elyzol Metronidazolum tab. 500mg N24 Dumex<br />

1739. Emadine Emedastinum eye drops, sol. 0,5mg/ml 5ml;10ml Alcon-Couvreur/<br />

Alcon Cusi<br />

1740. EMB-Fatol Ethambutolum film-coated tab. 400mg<br />

N50; N100<br />

1741. Emetron Ondansetronum film-coated tab. 4mg<br />

N10<br />

1742. Emetron Ondansetronum film-coated tab. 8mg<br />

N10<br />

Fatol<br />

Gedeon Richter<br />

Gedeon Richter


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 193<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1743. Emetron Ondansetronum sol. for inj. 4mg/2ml<br />

amp. N5<br />

1744. Emetron Ondansetronum sol. for inj. 8mg/4ml<br />

amp. N5<br />

1745. Emlodin<br />

10 mg<br />

1746. Emlodin<br />

2,5 mg<br />

Strength Manufacturer<br />

Amlodipinum tab. 10mg N30 Egis<br />

Amlodipinum tab. 2,5mg N30 Egis<br />

1747. Emlodin 5 mg Amlodipinum tab. 5mg N30 Egis<br />

Gedeon Richter<br />

Gedeon Richter<br />

1748. Emox 1,2 % Naproxenum natricum gel 12mg/g 50g EMO Pharmaceutics<br />

and Cosmetics Plant<br />

1749. Emox 10 % Naproxenum gel 100mg/g 50g EMO Pharmaceutics<br />

and Cosmetics Plant<br />

1750. E-Mulsin Tocopherolum oral emuls. 100mg/ml<br />

50g; 100g<br />

1751. Emu-V Erythromycinum tab. 250mg Upjohn<br />

1752. Emzok 100mg Metoprololum film-coated<br />

extended-release<br />

tablets<br />

1753. Emzok 200mg Metoprololum film-coated<br />

extended-release<br />

tablets<br />

1754. Emzok 50mg Metoprololum film-coated<br />

extended-release<br />

tablets<br />

Mucos Emulsions<br />

100mg N30;N100 IVAX-CR a.s.<br />

200mg N30;N100 Ivax-CR a.s.<br />

50mg N30;N100 IVAX-CR a.s.<br />

1755. Enahexal Enalaprilum tab. 5mg<br />

N20; N30; N50; N100<br />

Salutas<br />

1756. Enahexal Enalaprilum tab. 10mg N20;N30;N50;N100 Salutas<br />

1757. Enahexal Enalaprilum tab. 20mg N20;N30;N50;N100 Salutas<br />

1758. Enalaprilio 5 mg tablete˙s Enalaprilum tab. 5 mg N20; N30; N60 Liuks<br />

1759. Enalaprilio 10 mg tablete˙s Enalaprilum tab. 10mg N20; N30; N60 Liuks<br />

1760. Enalaprilio 20 mg tablete˙s Enalaprilum tab. 20mg N20; N30; N60 Liuks<br />

1761. Enalapril-ratiopharm 5 mg Enalaprilum tab. 5mg<br />

N30<br />

1762. Enalapril-ratiopharm 10 mg Enalaprilum tab. 10mg<br />

N30<br />

1763. Enalapril-ratiopharm 20 mg Enalaprilum tab. 20mg<br />

N30<br />

1764. Enap Enalaprilum tab. 2,5mg N20 KRKA<br />

1765. Enap Enalaprilum tab. 20mg<br />

N20; N30<br />

1766. Enap Enalaprilum tab. 10mg<br />

N20; N30<br />

1767. Enap Enalaprilum sol. for inj. 1,25mg/ml 1ml amp. N5 KRKA<br />

Merckle<br />

Merckle<br />

Merckle<br />

KRKA<br />

KRKA


EN<br />

194 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

1768. Enap tablete˙s Enalaprilum tab. 5mg N20;N30 KRKA<br />

1769. Enap-H tablete˙s Enalaprilum+<br />

Hydrochlorothiazidum<br />

1770. Enap-HL tablete˙s Enalaprilum+<br />

Hydrochlorothiazidum<br />

tab. 10mg+25mg N20 KRKA<br />

tab. 10mg+ 12,5mg<br />

N20<br />

1771. Enarenal Enalaprilum tab. 10mg<br />

N20<br />

1772. Enarenal Enalaprilum tab. 5mg<br />

N20<br />

1773. Enarenal Enalaprilum tab. 20mg<br />

N20<br />

KRKA<br />

Polpharma/<br />

Norfachema<br />

Polpharma/<br />

Norfachema<br />

Polpharma/<br />

Norfachema<br />

1774. Enasuno Enalaprilum tablets 10mg N30 Delta Ltd.<br />

1775. Enasuno Enalaprilum tablets 20mg N30 Delta Ltd.<br />

1776. Enatec-10 Enalaprilum tab. 10mg N28 Mepha<br />

1777. Enatec-20 Enalaprilum tab. 20mg N28 Mepha<br />

1778. Enatec-5 Enalaprilum tab. 5mg N30 Mepha<br />

1779. Enazil 10 Enalaprilum tab. 10mg<br />

N20; N100<br />

1780. Enbrel powder and solvent for<br />

solution for injection<br />

Etanercept powder and<br />

solvent for sol.<br />

for inj.<br />

1781. Encepur adults Inactivated tick-borne<br />

encephalitis virus (strain K23)<br />

1782. Encepur children Inactivated tick-borne<br />

encephalitis virus (strain K23)<br />

1783. Encepur K Inactivated tick-borne<br />

encephalitis virus (strain K23)<br />

25mg/vial +1ml water for inj.<br />

in pre-filled syringe + 2<br />

alcohol swabs N4<br />

susp. for inj. 1,5µg/0,5ml pre-filled syringe<br />

N10; N20<br />

susp. for inj. 0,75µg/0,25ml pre-filled<br />

syringe N1<br />

susp. for inj. 0,75µg/0,5ml syringe N10;<br />

N20<br />

Pliva-Lachema<br />

John Wyeth &<br />

Brothers (Wyeth<br />

Labs.)<br />

Chiron Behring<br />

Chiron Behring<br />

Chiron Behring<br />

1784. Endatrakuri-mas Atracurii besilas sol. for inj. 1 % Endokrininai<br />

preparatai<br />

1785. Endazelastinas Azelastinum nasal drops, sol. 0,1 % Endokrininai<br />

preparatai<br />

1786. Endbetoptic Betaxololi hydrochloridum eye drops, sol. 0,5 % Endokrininai<br />

preparatai<br />

1787. Enddiklomak-sas Lidocaini hydrochloridum+<br />

Diclofenac sodium<br />

1788. Endekay Daily Fluoride<br />

Mouthrinse<br />

sol. for. inj. 0,2 %,7,5 % Endokrininai<br />

preparatai<br />

Natrii fluoridum sol. 0,05% 250ml Stafford-Miller<br />

1789. Endekay Fluodrops Natrii fluoridum drops 0,55mg/0,15ml 60ml Stafford-Miller<br />

1790. Endekay Fluotabs 2-4 Natrii fluoridum tab. 1,1mg N200 Stafford-Miller<br />

1791. Endekay Fluotabs 4+ Natrii fluoridum tab. 2,2mg N200 Stafford-Miller<br />

1792. Endketanovas Ketorolac sol. for. inj. 3 % Endokrininai<br />

preparatai<br />

1793. Endklemastinas Clemastini fumaras sol. for inj. 0,1 % Endokrininai<br />

preparatai


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 195<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

1794. Endloranas Loratidinum tab. 10 mg Endokrininiai<br />

preparatai<br />

1795. Endmidazolamas Midazolami hydrochloridum sol. for inj. 0,5 % Endokrininiai<br />

preparatai<br />

1796. Endobulin S/D Immunoglobulin G powder and<br />

solvent for sol.<br />

for inj./inf.<br />

1797. Endobulin S/D Immunoglobulin G powder and<br />

solvent for sol.<br />

for inj./inf.<br />

1798. Endobulin S/D Immunoglobulin G powder and<br />

solvent for sol.<br />

for inj./inf.<br />

1799. Endobulin S/D Immunoglobulin G powder and<br />

solvent for sol.<br />

for inj./inf.<br />

1800. Endobulin S/D Immunoglobulin G powder and<br />

solvent for sol.<br />

for inj./inf.<br />

1801. Endobulin S/D Immunoglobulin G powder and<br />

solvent for sol.<br />

for inj./inf.<br />

500mg<br />

N1<br />

1 000mg<br />

N1<br />

2 500mg<br />

N1<br />

5 000mg<br />

N1<br />

7 500mg<br />

N1<br />

10 000mg<br />

N1<br />

1802. End-Oksimetazolinas 0,025 % Oxymetazolinum eye drops, sol. 0,25mg/ml 1,5ml amp. N10;<br />

5ml bottle N1<br />

1803. End-Oksimetazolinas 0,05 % Oxymetazolinum nasal spray, sol. 0,5mg/ml 1,5ml amp. N10;<br />

5ml bottle N1<br />

Baxter<br />

Baxter<br />

Baxter<br />

Baxter<br />

Baxter<br />

Baxter<br />

Endokrininiai<br />

preparatai<br />

Endokrininiai<br />

preparatai<br />

1804. End-Oksitocinas 5 TV Oxytocinum sol. for inj. 5 UI/ml 1ml amp. N10 Endokrininiai<br />

preparatai<br />

1805. Endotelon Procyanidolis oligomers enteric-coated<br />

tab.<br />

1806. Endotelon Procyanidolis oligomers enteric-coated<br />

tab.<br />

1807. Endoxan Cyclophosphamidum sugar-coated<br />

tab.<br />

1808. Endoxan 200 mg Cyclophosphamidum powder for sol.<br />

for inj.<br />

1809. Endoxan 500 mg Cyclophosphamidum powder for sol.<br />

for inj.<br />

1810. Endoxan 1 g Cyclophosphamidum powder for sol.<br />

for inj.<br />

150mg<br />

N20<br />

50mg<br />

N20<br />

50mg<br />

N50<br />

200mg/vial<br />

N1<br />

500mg/vial<br />

N1<br />

1g/vial<br />

N1<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

Asta Medica<br />

Asta Medica<br />

Asta Medica<br />

Asta Medica<br />

1811. Endsimvastatinas Simvastatinum tab. 40 mg Endokrininai<br />

preparatai<br />

1812. Endsumatriptanas Sumatriptani succinas nasal drops, sol. 0,02 % Endokrininai<br />

preparatai<br />

1813. End-Timololis 0,25 % Timololum eye drops, sol. 2,5mg/ml 1,5ml N4; N10; 5ml Endokrininiai<br />

preparatai<br />

1814. End-Timololis 0,5 % Timololum eye drops, sol. 5mg/ml 1,5ml; N4; N10; 5ml Endokrininiai<br />

preparatai<br />

1815. End-Unitiolas 5% Unithiolum solution for<br />

injection<br />

5% 5ml amp. N10 Endokrininiai<br />

preparatai AB


EN<br />

196 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

1816. Engerix-B Hepatitis B vaccine,<br />

recombinant (purified HBsAg)<br />

1817. Engerix-B Hepatitis B vaccine,<br />

recombinant (purified HBsAg)<br />

1818. Engerix-B (Junior dose) Hepatitis B vaccine,<br />

recombinant (purified HBsAg)<br />

1819. Engerix-B (Junior dose) Hepatitis B vaccine,<br />

recombinant (purified HBsAg)<br />

1820. Engystol Vincetoxinum hirundinaria D6<br />

+Vincetoxinum hirundinaria<br />

D10 + Vincetoxinum<br />

hirundinaria D30 +Sulfur D4 +<br />

Sulfur D10<br />

1821. Enhancin Tablets 250/125 mg Amoxicillinum+ Acidum<br />

clavulanicum<br />

1822. Enhancin Tablets 500/125 mg Amoxicillinum+ Acidum<br />

clavulanicum<br />

1823. Enterol 250 Lyophilized cells of<br />

Saccharomyces boulardii<br />

1824. Enterol 250 Lyophilized cells of<br />

Saccharomyces boulardii<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

susp. for inj. 20µg/ml vial N1; N25 SmithKline Beecham<br />

susp. for inj. 20µg/ml pre-filled syringe N1 SmithKline Beecham<br />

susp. for inj. 10µg/0,5ml vial N1;N25;<br />

N100<br />

susp. for inj. 10µg/0,5ml pre-filled syringe<br />

N1<br />

tab. 75mg+75mg+75mg+<br />

37,5mg+ 37,5mg<br />

N50; N250<br />

SmithKline Beecham<br />

SmithKline Beecham<br />

Heel<br />

film-coated tab. 250mg+125mg N21 Ranbaxy<br />

film-coated tab. 500mg+125mg N21 Ranbaxy<br />

caps. 250mg<br />

N10<br />

1825. Enypril 10 mg Enalaprilum tab. 10mg<br />

N30<br />

1826. Enypril 20 mg Enalaprilum tab. 20mg<br />

N30<br />

1827. Enypril 5 mg Enalaprilum tab. 5mg<br />

N30<br />

1828. Enzystal Pancreatin+ Hemicellulase+<br />

Extr.Fellis Bovis<br />

Biocodex<br />

powder 250mg sachet N10 Biocodex<br />

enteric-coated<br />

tab.<br />

1829. Eosine Gifrer Disodium eosin cutaneous<br />

solution<br />

1830. Eoxx Erythropoietin human<br />

recombinant<br />

sol.for inj. in<br />

prefilled<br />

syringes<br />

1831. Ephedrin Biotica Ephedrinum solution for<br />

injection<br />

1832. Epirubicin ‘Ebewe’ 10 mg Epirubicinum concentrate for<br />

sol. for inf.<br />

1833. Epirubicin ‘Ebewe’ 100 mg Epirubicinum concentrate for<br />

sol. for inf.<br />

1834. Epirubicin ‘Ebewe’ 200 mg Epirubicinum concentrate for<br />

sol. for inf.<br />

1835. Epirubicin ‘Ebewe’ 50 mg Epirubicinum concentrate for<br />

sol. for inf.<br />

1836. Epivir 10 mg/ml oral solution Lamivudinum oral sol. 10mg/ml<br />

240ml<br />

1837. Epivir 150 mg film-coated<br />

tablets<br />

1838. Epoxx Erythropoietin human<br />

recombinant<br />

Lamivudinum film-coated tab. 150mg<br />

N60<br />

sol.for inj. in<br />

prefilled<br />

syringes<br />

192mg+ 50mg+ 25mg N100 Torrent<br />

2g/100ml unit-dose containers<br />

2ml; 5ml; 10ml; 45ml; 100ml<br />

Delta/<br />

Nycomed SEFA<br />

Delta/<br />

Nycomed SEFA<br />

Delta/<br />

Nycomed SEFA<br />

Gifrer<br />

4000 IU Sicor Biotech<br />

50mg/ml 1ml amp. N10 Hoechst Biotika spol<br />

s.r.o.<br />

10mg/5ml vial N1 Ebewe<br />

100mg/50ml vial N1 Ebewe<br />

200mg/ 100mlvial N1 Ebewe<br />

50mg/25ml vial N1 Ebewe<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

1000 IU Sicor Biotech


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 197<br />

No. Commercial name General name<br />

1839. Epoxx Erythropoietin human<br />

recombinant<br />

1840. Epoxx Erythropoietin human<br />

recombinant<br />

1841. Epoxx Erythropoietin human<br />

recombinant<br />

Pharmaceutical<br />

form<br />

sol.for inj. in<br />

prefilled<br />

syringes<br />

sol.for inj. in<br />

prefilled<br />

syringes<br />

sol.for inj. in<br />

prefilled<br />

syringes<br />

Strength Manufacturer<br />

2000 IU Sicor Biotech<br />

5000 IU Sicor Biotech<br />

10000 IU Sicor Biotech<br />

1842. Eprex Epoetinum alfa sol. for inj. 336µg<br />

(40 000 IU)/ ml single use vial<br />

N1<br />

1843. Eprex 1 000 Epoetinum alfa sol. for inj. 8,4µg<br />

(1 000 IU) /0,5ml prefilled<br />

syringes N6<br />

1844. Eprex 10 000 Epoetinum alfa sol. for inj. 84µg<br />

(10 000 IU)/ml 1ml prefilled<br />

syringes N6<br />

1845. Eprex 2 000 Epoetinum alfa sol. for inj. 16,8µg<br />

(2 000 IU) /0,5ml prefilled<br />

syringes N6<br />

1846. Eprex 3 000 Epoetinum alfa solution for<br />

injection<br />

Cilag<br />

Cilag<br />

Cilag<br />

Cilag<br />

25,3µg/0,3ml syringes N6 Cilag AG<br />

1847. Eprex 4 000 Epoetinum alfa sol. for inj. 33,6µg<br />

(4 000 IU) /0,4ml prefilled<br />

syringes N6<br />

1848. Eprex 5000 Epoetinum alfa solution for<br />

injection<br />

1849. Eprex 6000 Epoetinum alfa solution for<br />

injection<br />

1850. Eprex 8000 Epoetinum alfa solution for<br />

injection<br />

Cilag<br />

42µg/0,5ml syringes N6 Cilag AG<br />

50,4µg/0,6ml syringes N6 Cilag AG<br />

67,2µg/0,8ml syringes N6 Cilag AG<br />

1851. Erazon Piroxicamum caps. 10mg N20 KRKA<br />

1852. Ercefuryl 200 mg Nifuroxazidum caps. 200mg<br />

N28<br />

1853. Eremfat 300 Rifampicinum film-coated tab. 300mg<br />

N50; N100<br />

1854. Eremfat 600 Rifampicinum film-coated tab. 600mg<br />

N30; N100<br />

1855. Ergokalciferolio (Vitamino D2)<br />

0,125 % aliejinis tirpalas<br />

Synthelabo<br />

Fatol<br />

Fatol<br />

Ergocalciferolum sol.oleosa 50000UI/ml 15ml Sanitas<br />

1856. Erinito tablete˙s Erynitum tab. 0,01 N40 Liuks<br />

1857. Eritromicino tablete˙s Erythromycinum tab. 0,1 g N20 Liuks<br />

1858. Erolin Loratadinum tab. 10mg<br />

N10; N30<br />

1859. Erolin Loratadinum sir. 5mg/5ml 120ml Egis<br />

1860. Erške˙čio vaisiai Fruct. Rosae herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

1861. Erške˙čiu˛ vaisiai (smulkinti) Fruct. Rosae herbal tea 100g; 48g(2g×24) Švenčioniu˛<br />

vaistazˇole˙s<br />

Egis


EN<br />

198 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1862. Erybesan Erythromycinum granules for<br />

oral susp.<br />

Strength Manufacturer<br />

200mg/5ml 60ml Biochemie<br />

1863. Erybesan Erythromycinum film-coated tab. 250mg N12 Biochemie<br />

1864. Erybesan Erythromycinum film-coated tab. 500mg N12 Biochemie<br />

1865. Erylik Erythromycinum+<br />

Tretinoinum<br />

gel for<br />

application to<br />

the skin<br />

4g+25mg/ 100g 30g Laboratoires Biorga<br />

1866. Erynitum Pentaerithritylum tab. 0,01g N10, N20; N30; N50;<br />

N60<br />

1867. Erythran 125 Erythromycinum gran. for oral<br />

susp.<br />

1868. Erythran 250 Erythromycinum gran. for oral<br />

susp.<br />

1869. Erythromycin Erythromycinum coated tab. 200mg<br />

N16<br />

1870. Erythromycin — Teva Erythromycinum powder for<br />

susp.<br />

1871. Erythromycin — Teva Erythromycinum powder for<br />

susp.<br />

1872. Erythromycin — Teva Erythromycinum powder for<br />

susp.<br />

Liuks<br />

125mg/5ml 1,5g(60ml) Balkanpharma-<br />

Razgrad<br />

250mg/5ml 3g(60ml) Balkanpharma-<br />

Razgrad<br />

200mg/5ml 60ml Teva<br />

125mg/5ml 60ml Teva<br />

400mg/5ml 60ml Teva<br />

Polfa Tarchomin<br />

1873. Erythrostad 500 Erythromycinum film-coated tab. 500mg N10;N20;N30 Heinz Haupt<br />

1874. Erytran 200 Erythromycinum gran. 200mg/5ml 120ml Spirig<br />

1875. Esmeron Rocuronii bromidum sol. for inj. 10mg/ml 5ml vials N12;10ml<br />

vials N12; 25ml vials N4<br />

Organon/<br />

Laboratoires<br />

Organon<br />

1876. espa-lipon 200 Acidum alfa-lipoicum film-coated tab. 200mg N30; N100 esparma<br />

1877. espa-lipon 600 Acidum alfa-lipoicum film-coated tab. 600mg N30; N60; N100 esparma<br />

1878. espa-lipon inj. 300 Acidi alfalipoici<br />

ethylendiaminum (Acidum<br />

alfa-lipoicum)<br />

sol. for inj. 387,6mg (300mg)/ 12ml amp.<br />

N10; N20<br />

1879. espa-lipon inj. 600 Acidum alfa-lipoicum sol. for inj. 600mg/24ml N5; N10; N20<br />

amp.<br />

1880. Esperal Disulfiramum tab. 500mg<br />

N20<br />

esparma<br />

esparma<br />

Sanofi-Synthelabo<br />

1881. Espumisan Simeticonum caps. 40mg N25; N50; N100 Berlin-Chemie<br />

1882. Espumisan D Dimeticonum chew. tab. 40mg Berlin-Chemie<br />

(Menarini Group)<br />

1883. Espumisan L Dimeticonum oral emulsion 40mg/ml<br />

30ml<br />

1884. Essaven Gel Aescinum+ Heparinum<br />

natricum+ Essential<br />

phospholipids<br />

1885. Essentiale forte N Phospholipidu ex sojae caps. 300mg<br />

N30<br />

Berlin-Chemie<br />

(Menarini Group)<br />

gel 1g+ 10 000 UI+ 1g/100g 40g Nattermann<br />

Nattermann<br />

1886. Essentiale N Phospholipida ex sojae sol. for inj. 250mg/5ml amp. N5 Nattermann


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 199<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1887. Estazolam Estazolamum tab. 2mg<br />

N20<br />

1888. Estracomb TTS Estraderm TTS 50<br />

(Estradiolum) and Estragest<br />

TTS 0,25/50 (Estradiolum+<br />

Norethisteronum)<br />

Strength Manufacturer<br />

Polfa Tarchomin<br />

patches 4mg N4 and 10mg+30mg N4 Ciba-Geigy<br />

1889. Estracyt Estramustine phosphate caps. 140mg Pharmacia AB<br />

1890. Estraderm TTS 100 Estradiolum transdermal<br />

patch<br />

1891. Estraderm TTS 25 Estradiolum transdermal<br />

patch<br />

1892. Estraderm TTS 50 Estradiolum transdermal<br />

patch<br />

1893. Estradot 100 Estradiolum transdermal<br />

patches<br />

1894. Estradot 25 Estradiolum transdermal<br />

patches<br />

1895. Estradot 37,5 Estradiolum transdermal<br />

patches<br />

1896. Estradot 50 Estradiolum transdermal<br />

patches<br />

1897. Estradot 75 Estradiolum transdermal<br />

patches<br />

1898. Estramon 100 Estradiolum transdermal<br />

patch<br />

1899. Estramon 25 Estradiolum transdermal<br />

patch<br />

1900. Estramon 50 Estradiolum transdermal<br />

patch<br />

8mg/20cm 2 (100µg/24h) N6 Novartis Pharma<br />

2mg/5cm 2 (25µg/24h) N6 Novartis Pharma<br />

4mg/10cm 2 (50µg/24h) N24 Novartis Pharma<br />

1,56mg/10cm 2 N8 Noven<br />

Pharmaceuticals Inc.<br />

0,39mg/2,5cm 2 N8 Noven<br />

Pharmaceuticals Inc.<br />

0,585mg/3,75cm 2 N8 Noven<br />

Pharmaceuticals Inc.<br />

0,78mg/5cm 2 N8 Noven<br />

Pharmaceuticals Inc.<br />

1,17mg/7,5cm 2 N8 Noven<br />

Pharmaceuticals Inc.<br />

8mg/40cm 2 N6; N18; N24 Hexal<br />

2mg/10cm 2 N6; N18; N24 Hexal<br />

4mg/20cm 2 N6; N18; N24 Hexal<br />

1901. Estreva Estradiolum gel 100mg/100g 50g Theramex<br />

1902. Estreva Estradiolum scored tab. 1,5mg<br />

N28<br />

1903. Estrimax Estradiolum film-coated tab. 2mg<br />

N28; N3×28<br />

Theramex<br />

Gedeon Richter<br />

1904. Estrofem Estradiolum tab. 1mg N28; N84 Novo Nordisk<br />

1905. Estrofem 2 mg Estradiolum film-coated tab. 2mg<br />

N28<br />

1906. Estrogel Estradiolum gel 0,6mg/g 80g Leiras<br />

1907. Etacizins 50 mg Ethacizinum coated tab. 50mg<br />

N50<br />

1908. Etamzilats 250 mg Etamsylatum tab. 250mg<br />

N50<br />

Novo Nordisk<br />

OlainFarm<br />

OlainFarm<br />

1909. Ethambutol Ethambutolum caps. 250mg N250 Pliva Krakow<br />

1910. Etilchlorido purškalas Ethylis chloridum aerosol 88g (100ml) N1; N10 Walter Ritter<br />

GmbH+Co<br />

1911. Etmozins 100 mg Moracizinum coated tab. 100mg<br />

N50<br />

OlainFarm


EN<br />

200 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1912. Etomidate-Lipuro Etomidatum emulsion for<br />

inj.<br />

Strength Manufacturer<br />

20mg/10ml amp. N10 Braun Melsungen<br />

1913. Etopos Etoposidum sol. for inj. 100mg/5ml N1 Lemery<br />

1914. Etoposid ‘Ebewe’<br />

100 mg<br />

1915. Etoposid ‘Ebewe’<br />

50 mg<br />

Etoposidum concentrate for<br />

sol. for inf.<br />

Etoposidum concentrate for<br />

sol. for inf.<br />

1916. Etoposide Etoposidum conc. for sol.<br />

for inf.<br />

100mg/5ml vial N1 Ebewe<br />

50mg/2,5ml vial N1 Ebewe<br />

20mg/ml 5ml; 10ml Abic for Teva<br />

1917. Etoposide Etoposidum sol. for inj. 20mg/ml 5ml vials N1; N10 Pharmacia & Upjohn<br />

1918. Etoposide Pierre Fabre Etoposidum concentrate for<br />

sol. for inf.<br />

100mg/5ml<br />

N5<br />

1919. Etovit-200 Tocopherolum caps. 200mg N30 USV<br />

1920. Etovit-400 Tocopherolum caps. 400mg N100 USV<br />

1921. Eucabal N Ol.Camphorae+ Ol.Pini emuls. 10g+ 6g/100g 40ml; 100ml esparma<br />

1922. Eucabal-Balsam S Eucalypti aetheroleum+ Pini<br />

aetheroleum<br />

1923. Eucabal-Hustensaft Extr.Thymi fl.+ Extr.<br />

Plantaginis lanceolatae fl.<br />

(Ethanolum 6,5%)<br />

1924. Eucabal-Hustentropfen Extr.Thymi fl.+ Extr. Droserae<br />

fl. (Ethanolum 31,7 %)<br />

1925. Eucarbon Herbal Sennae folium+Rhei extr.+<br />

Carbo Ligni pulv.<br />

1926. Eufilino 2,4 % tirpalas<br />

injekcijoms<br />

1927. Eufilino 2,4 % tirpalas<br />

injekcijoms<br />

A.P.I.<br />

emuls. 10g+3g/100g 40ml; 100ml esparma<br />

syrup 15g+ 3g/100g 100ml; 250ml esparma<br />

oral drops 21g+ 14g/100g 20ml esparma<br />

tab. 105mg+ 25mg+ 180mg N10;<br />

N30; N100<br />

Theophyllinum sol. for inj. 24mg/ml<br />

5ml amp. N10<br />

Aminophyllinum sol. for inj. 120mg/5ml amp.<br />

N10<br />

1928. Eufilino tablete˙s Euphyllinum tab. 0,15 g N20 Liuks<br />

1929. Eukaliptu˛ tinktūra Fol. Eucalipti tinct. 200 g Ethanolum ad 1l 50 ml;<br />

100ml<br />

F.Trenka<br />

Sanitas<br />

Endokrini-niai<br />

preparatai<br />

Bakteriniai<br />

preparatai<br />

1930. Eukaliptu˛ tinktūra (1:5) Eucalypti folium liquid 50ml;100ml Bakteriniai<br />

preparatai AB<br />

1931. Eunoctin Nitrazepamum tab. 10mg<br />

N10<br />

1932. Euphorbium compositum S Euphorbinum D4+Pulsatilla<br />

D2+Luffa operculata D2+<br />

Mercurius bijodatus D8+<br />

Mucosa nasalis suis D8+Hepar<br />

sulfuris D10+Argentum<br />

nitricum D10+Sinusitis-Nosode<br />

D13<br />

1933. Euphorbium compositum S Euphorbium D3+Pulsatilla<br />

D2+Luffa operculata D6+<br />

Mercurius bijodatus D8+<br />

Mucosa nasalis suis D8+Hepar<br />

sulfuris D10 +Argentum<br />

nitricum D10 +Sinusitis-<br />

Nosode D13 (Ethanolum<br />

45 vol.-%)<br />

nasal drops 1g+1g+1g+1g+1g+1g+1g+<br />

1g/100g<br />

20ml<br />

oral drops 1g+1g+1g+1g+1g+1g+1g+1g<br />

/100g 30ml;100ml<br />

Gedeon Richter<br />

Heel<br />

Heel


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 201<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

1934. Euthyrox 100 Levothyroxinum natricum tab. 100µg<br />

N50<br />

Strength Manufacturer<br />

1935. Euthyrox 50mcg Levothyroxinum tablets 50mcg N50;N100 Merck KGaA<br />

1936. Euvax-B Inj. Hepatitis B vaccine,<br />

recombinant (purified HBsAg)<br />

1937. Euvax-B Inj. Hepatitis B vaccine,<br />

recombinant (purified HBsAg)<br />

inj. 20µg/ml 1ml vials N1; N20;<br />

N50; 5ml, 10ml vials N1;N10<br />

inj. 10µg/0,5ml vials N1; N20;<br />

N50<br />

Merck<br />

LG Chemical<br />

LG Chemical<br />

1938. Evista Raloxifenum film-coated tab. 60mg N28 Eli Lilly<br />

1939. Evitol Tocopherolum lozenges 100mg N30 KRKA<br />

1940. Excipial Lipidu˛ kiekis cream 35,5% 30g;100g Spirig<br />

1941. Excipial (riebus kremas) Lipidu˛ kiekis cream 54% 30g;100g Spirig<br />

1942. Excipial (tepalas su migdolu˛<br />

aliejumi)<br />

Lipidu˛ kiekis ointment 96% 30g;100g Spirig<br />

1943. Excipial Fatty Ointment — ointment 100g Spirig<br />

1944. Excipial U Hydrolotio Ureum emulsion (‘oil in<br />

water’ type)<br />

2mg/ml<br />

200ml; 500ml<br />

1945. Excipial U Lipolotio Ureum emulsion 4mg/ml<br />

200ml; 500ml<br />

Spirig Pharma<br />

Spirig Pharma<br />

1946. Exelon Rivastigminum caps., hard 4,5mg N28; N56; N112 Novartis<br />

Pharmaceutica<br />

1947. Exelon Rivastigminum oral sol. 2mg/ml 120ml Novartis<br />

1948. Exelon Rivastigminum caps., hard 6mg N28; N56; N112 Novartis<br />

Pharmaceutica<br />

1949. Exelon Rivastigminum caps., hard 3mg N28; N56; N112 Novartis<br />

Pharmaceutica<br />

1950. Exelon Rivastigminum caps., hard 1,5mg N28; N56; N112 Novartis<br />

Pharmaceutica<br />

1951. Exoderil 1% cream Naftifinum cream 10mg/g 15g;30g Biochemie<br />

1952. Exoderil solution Naftifinum sol. 10mg/ml Biochemie<br />

1953. Exosurf Neonatal Colfoscerili palmitas powder and<br />

solvent for sol.<br />

for inj.<br />

1954. Extra Strength Tylenol Paracetamolum film-coated<br />

caplets<br />

1955. Extraneal (Icodextrin 7,5 %) Icodextrinum Solution for<br />

peritoneal<br />

dialysis<br />

108mg/vial and 8ml solvent Glaxo Wellcome<br />

500mg<br />

N30; N200<br />

75g/1000ml 1500ml; 2000ml;<br />

2500ml<br />

1956. Ezˇiuole˙s tiktūra Extr. Echinaceae Purpurae tinct. 30 ml Liuks<br />

1957. Factor VII Concentrate Tim 4<br />

Immuno<br />

500 IU<br />

1958. Falimint Acetylaminonitropropoxybenzenum<br />

Factor VII powder and<br />

solvent for<br />

solution for<br />

injection<br />

McNeil/<br />

Grindex<br />

Baxter<br />

500 IU/10ml vial+needles N1 Baxter AG<br />

coated tab. 25mg N20 Berlin-Chemie<br />

1959. Famogast Famotidinum coated tab. 20mg N20 Polpharma


EN<br />

202 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

1960. Famogast Famotidinum coated tab. 40mg N20 Polpharma<br />

1961. Famosan Famotidinum coated tab. 40mg N10 Pro. Med. CS Praha<br />

1962. Famosan Famotidinum coated tab. 20mg N20 Pro. Med. CS Praha<br />

1963. Famotidin 20-SL Famotidinum coated tab. 20mg<br />

N30<br />

1964. Famotidin 40-SL Famotidinum coated tab. 40mg<br />

N10<br />

1965. Famotidino<br />

20 mg tablete˙s<br />

Famotidinum tab. 20 mg N10, N30 Liuks<br />

1966. Famotidino 40 mg tablete˙s Famotidinum tab. 40 mg N10, N30 Liuks<br />

1967. Famvir Famciclovirum coated tab. 125mg<br />

N10; N30<br />

1968. Famvir Famciclovirum coated tab. 250mg<br />

N15; N21<br />

1969. Famvir Famciclovirum coated tab. 500mg<br />

N14; N21<br />

Slovakofarma<br />

Slovakofarma<br />

1970. Faringosept Ambazonum tab. 10mg N20 Terapia<br />

SmithKline Beecham<br />

SmithKline Beecham<br />

SmithKline Beecham<br />

1971. Farmorubicin PFS Epirubicinum sol. for inj. 10mg/5ml vial N1 Pharmacia & Upjohn<br />

Nerviano<br />

1972. Farmorubicin PFS Epirubicinum sol. for inj. 50mg/10ml vial N1 Pharmacia & Upjohn<br />

Nerviano<br />

1973. Farmorubicin Rapid<br />

Dissolution<br />

1974. Farmorubicin Rapid<br />

Dissolution<br />

Epirubicinum powder and<br />

solvent for sol.<br />

for inj.<br />

Epirubicinum powder and<br />

solvent for sol.<br />

for inj.<br />

10mg/vial and 5ml amp. with<br />

solvent (water) N1<br />

50mg/vial and 5ml amp. with<br />

solvent (water) N1<br />

1975. Fastum Gel Ketoprofenum gel 25mg/g<br />

20g; 30g; 50g<br />

1976. Favirab F(ab) fragments of equine<br />

antirabies immunoglobulin<br />

solution for<br />

injection<br />

5ml(1000-2000 IU) 5ml vial<br />

N1;N10<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Menarini<br />

Aventis Pasteur A.S.<br />

1977. Febichol Fenipentolum caps. 100mg N50 Slovakofarma<br />

1978. Febret Capsules 200mg Etodolacum caps. 200mg N60 Ranbaxy<br />

1979. Febret Capsules 300mg Etodolacum caps. 300mg N60 Ranbaxy<br />

1980. Feiba TIM 4 Immuno<br />

1 000 Feiba units<br />

1981. Feiba TIM 4 Immuno 500<br />

Feiba units<br />

Factor VIII inhibitor bypassing<br />

activity<br />

Factor VIII inhibitor bypassing<br />

activity<br />

powder and<br />

solvent for sol.<br />

for inj./inf.<br />

powder and<br />

solvent for sol.<br />

for inj./inf.<br />

1 000U/vial N1 Baxter<br />

500U/vial<br />

N1<br />

1982. Feldene Piroxicamum caps., hard 10mg N30 Pfizer<br />

1983. Feldene Piroxicamum caps., hard 20mg N30 Pfizer<br />

1984. Feldene Piroxicamum sol. for inj. 20mg/ml 1ml amp. N2; N6 Pfizer<br />

1985. Feldene Piroxicamum gel 5mg/g 25g Pfizer<br />

Baxter


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 203<br />

No. Commercial name General name<br />

1986. Felodipine Alpharma Tablets<br />

5mg<br />

Pharmaceutical<br />

form<br />

Felodipinum prolonged<br />

release tablet<br />

1987. Feloran Diclofenacum natricum film-coated tab. 25mg<br />

N30<br />

1988. Feloran Diclofenacum natricum gel. 10mg/g<br />

60g<br />

Strength Manufacturer<br />

5mg N30 Omega Farma<br />

Iceland /Kern<br />

Pharma S.L.<br />

Balkanpharma-<br />

Dupnitza<br />

Balkanpharma-<br />

Troyan<br />

1989. Feloran Diclofenacum sol. for inj. 75mg/3ml Sopharma<br />

1990. Feloran 100mg Diclofenacum natricum coated tab. 100mg<br />

N30<br />

1991. Femalgin Plus Hyoscini-N-butylbromidum+<br />

Paracetamolum<br />

1992. Femalgin Plus Hyoscini-N-butylbromidum +<br />

Paracetamolum<br />

Balkanpharma-<br />

Dupnitza<br />

film-coated tab. 10mg+500mg N20 Boehringer<br />

Ingelheim<br />

supp. 10mg+800mg N5 Boehringer<br />

Ingelheim<br />

1993. Femara Letrozolum film-coated tab. 2,5mg Novartis Pharma<br />

1994. Feminon Pulsatilla+Agnus castus D1+<br />

Chelidonium D4+<br />

Cimicifuga D3+<br />

Phosphorus D4+<br />

Calcium carbonicum D10+<br />

Hamamelis D1<br />

1995. Femoden Gestodenum+<br />

Ethinylestradiolum<br />

1996. Femoston 1/10 Estradiolum; Estradiolum+<br />

Dydrogesteronum<br />

1997. Femoston 2/10 Estradiolum; Estradiolum+<br />

Dydrogesteronum<br />

1998. Femoston 2/20 Estradiolum; Estradiolum+<br />

Dydrogesteronum<br />

1999. Femoston conti Estradiolum+<br />

Dydrogesteronum<br />

oral drops 3,5ml+0,05ml+0,1ml+0,1ml+<br />

0,25ml+0,1ml+0,1ml/100ml<br />

30ml; 50ml; 100ml<br />

sugar-coated<br />

tab.<br />

2000. Fenistil 24 Dimetindenum prolongedrelease<br />

caps.,<br />

hard<br />

0,075mg+ 0,03mg<br />

N21<br />

film-coated tab. white tab.: 1mg; grey tab.:<br />

1mg+10mg N28; N84<br />

Redel<br />

Schering<br />

Solvay<br />

Pharmaceuticals<br />

coated tab. 2mg; 2mg+10mg N28 Solvay<br />

Pharmaceuticals<br />

coated tab. 2mg; 2mg+ 20mg N84 Solvay<br />

Pharmaceuticals<br />

film-coated tab. 1mg+5mg N28; N84 Solvay<br />

Pharmaceuticals<br />

4mg<br />

N10;N20<br />

Novartis<br />

2001. Fenistil drops Dimetindeni maleas oral drops, sol. 1mg/ml 20ml Novartis Consumer<br />

2002. Fenistil Gel Dimetindeni maleas gel 1mg/g 30g Novartis Consumer<br />

2003. Fenkarols 25mg Quifenadini hydrochloridum tab. 25mg<br />

N20<br />

2004. Fenobarbitalio 100 mg tablete˙s Phenobarbitalum tab. 100 mg N10; N30; N50; N60 Liuks<br />

2005. Fenobarbitalio 100mg tablete˙s Phenobarbitalum tab. 100mg<br />

N10<br />

2006. Fenobarbitalis Phenobarbitalum tab. 100mg<br />

N10<br />

2007. Fentanilio 0,005% tirpalas<br />

injekcijoms<br />

Fentanylum solution for<br />

injection<br />

OlainFarm<br />

Endokrininiai<br />

preparatai<br />

KMA vaistine˙<br />

0,005% 2ml amp. N10 Endokrininiai<br />

preparatai AB<br />

2008. Fentanyl Fentanylum sol. for inj. 0,25mg/5ml amp. N50 Gedeon Richter<br />

2009. Fentanyl Fentanylum sol. for inj. 50µg/ml 2ml N10; 10ml N5 Icelandic<br />

Pharmaceuticals


EN<br />

204 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2010. Fentanyl Fentanylum sol. for inj. 0,1mg/2ml amp. N10 Gedeon Richter<br />

2011. Fentanyl Fentanylum sol. for inj. 0,05mg/ml 10ml amp. N10;<br />

N50<br />

2012. Fentanyl Fentanylum sol. for inj. 0,05mg/ml 2ml amp. N10;<br />

N50<br />

2013. Fenules Ferrosi sulfas+ Thiaminum+<br />

Riboflavinum+ Acidum<br />

ascorbicum+ Nicotinamidum+<br />

Acidum pantothenicum+<br />

Pyridoxinum<br />

2014. Feroplekt Ferri sulfas+ Aacidum<br />

ascorbicum<br />

2015. Ferretab comp. Ferrosi fumaras+<br />

Acidum folicum<br />

caps. 150mg+ 2mg+ 2mg+ 50mg+<br />

15mg+ 2,5mg+ 1mg N10<br />

Polfa Warsaw<br />

Polfa Warsaw<br />

Ranbaxy<br />

tab. N50 Liuks<br />

caps. 154mg+0,6mg N30 Lannacher<br />

2016. Ferrocaps Fe (II) + Folic acid caps. 50 mg+0,5mg Sanitas<br />

2017. Ferro-Folgamma Cyanocobalamin+<br />

Folic acid+<br />

Ferrous sulfate<br />

2018. Ferro-Gradumet Ferrosi sulfas anhydricum<br />

(Ferrum)<br />

caps. 10µg+5mg+<br />

111,822-117,023mg<br />

modified-release<br />

tab.<br />

325mg (105mg)<br />

N30<br />

2019. Ferronal 35 syrup Ferrosi gluconas (Fe 2+) syrup 300mg (35mg)/5ml 110ml CTS<br />

2020. Ferroplex Acidum ascorbicum+<br />

Ferri sulfas<br />

2021. Ferrovin China Eisenwein Ferri ammonii citras+ Mangani<br />

hypophosphas+ Chinae<br />

extractum fluidum+<br />

Aurantii amari tinctura<br />

2022. Ferrum Lek Ferri (III) hydroxidum cum<br />

polymaltosi complexus<br />

2023. Ferrum Lek Ferri (III) hydroxidum cum<br />

polymaltosi complexus<br />

2024. Ferrum Lek i.m. injections<br />

2ml<br />

Ferrum (in the form of ferric<br />

III hydroxide polyisomaltose<br />

complex)<br />

2025. Fervex Paracetamolum+ Acidum<br />

ascorbicum+ Pheniraminum<br />

Worwag Pharma<br />

Abbott<br />

drag. 30mg+50mg N30 Biogal<br />

oral sol. 500mg+5mg+500mg+<br />

200mg/100g (Ethanolum<br />

17,5 vol.-%) 700ml<br />

chewable tab. 100mg N30 Lek<br />

syrup 50mg/5ml 100ml Lek<br />

sol.for inj. 100mg/2ml amp. N5;N50 Lek<br />

gran. for oral<br />

sol.<br />

2026. Fervex Ambrox Ambroxolum efferv.tab. 30mg<br />

N10<br />

2027. Fervex Dry Cough Paracetamolum+ Acidum<br />

ascorbicum+<br />

Dextromethorphani<br />

hydrobromidum<br />

2028. Fervex for children Paracetamolum+ Acidum<br />

ascorbicum+ Pheniraminum<br />

2029. Fervex Rhinitis Paracetamolum+<br />

Pseudoepherinum+<br />

Chlorphenaminum<br />

500mg+200mg+25mg/ sachet<br />

N8 po 13,1g<br />

efferv. tab. 300mg+150mg+15mg<br />

N10<br />

gran. for oral<br />

sol.<br />

280mg+100mg+10mg/sachet<br />

N8 po 3g<br />

tab. 500mg+30mg+2mg<br />

N6; N8; N15<br />

2030. Fevarin Fluvoxaminum film-coated tab. 50mg<br />

N15; N30<br />

Pharmonta<br />

UPSA<br />

Pharmavit<br />

Pharmavit<br />

UPSA<br />

UPSA<br />

Solvay<br />

Pharmaceuticals


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 205<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2031. Fevarin Fluvoxaminum film-coated tab. 100mg<br />

N15; N30<br />

2032. Fibrex Hot Drink Acidum acetylsalicylicum+<br />

Acidum ascorbicum<br />

2033. Fibrolan ointment Plasmin (bovine)+<br />

Desoxyribonuclease (bovine)<br />

powder for oral<br />

sol.<br />

Strength Manufacturer<br />

Solvay<br />

Pharmaceuticals<br />

500mg+ 100mg sachet N10 Berlin-Chemie<br />

(Menarini Group)<br />

ointment 1U+666U/g 25g Parke-Davis<br />

2034. Finalgel Sport Piroxicamum gel 0,5g/100g 35g; 50g Boehringer<br />

Ingelheim<br />

2035. Finalgon Nonivamidum+ Nicoboxilum ointment 4mg+ 25mg/g 20g Schering Wien<br />

2036. Finlepsin Carbamazepinum tab. 200mg<br />

N50<br />

2037. Finlepsin 200 retard Carbamazepinum tab. 200mg N50; N100; N200 AWD<br />

2038. Finlepsin 400 retard Carbamazepinum tab. 400mg N50; N100; N200 AWD<br />

2039. Finoptin Verapamilum tab. 40mg<br />

N30; N100<br />

2040. Finoptin Verapamilum tab. 80mg<br />

N30; N100<br />

2041. Fisherman's Friend Original<br />

Extra Strong Lozenges<br />

2042. Fisherman's Friend Original<br />

Sugar Free Lozenges<br />

2043. Fisherman's Friend Super<br />

Strong Mint Lozenges<br />

2044. Fitoprost Serenoae repentis fructi<br />

extractum<br />

Mentholum lozenges 0,9%<br />

25g<br />

Mentholum lozenges 0,9%<br />

25g<br />

2045. Fitoval Faex medicinalis+ Cystinum+<br />

Calcii pantothenas+Thiamini<br />

nitras+ Riboflavinum+<br />

Pyridoxini hydrochloridum+<br />

Biotinum +<br />

Cyanocobalaminum+ Acidum<br />

folicum +Ferrum (II) +<br />

Zincum+Cuprum<br />

2046. Flagyl<br />

250 mg<br />

2047. Flagyl<br />

500 mg<br />

AWD<br />

Orion<br />

Orion<br />

Lofthouse<br />

Lofthouse<br />

Menthol+ Peppermint oil lozenges 0,4%+0,98% 25g Lofthouse<br />

caps. 160mg<br />

N60<br />

caps. 200mg+ 100mg+ 35mg+<br />

2mg+2mg+2mg+ 0,1mg+2µg+<br />

0,2mg+ 10mg+5mg+1mg N60<br />

Hasco-Lek<br />

KRKA<br />

Metronidazolum tab. 250mg N20 Rhone-Poulenc<br />

Rorer<br />

Metronidazolum vaginal supp. 500mg N10 Rhone-Poulenc<br />

Rorer<br />

2048. Flarex Fluorometholonum ophthalmic<br />

suspension<br />

0,1% 5ml s.a. Alcon-Couvreur<br />

N.V.<br />

2049. Flavamed cough drops Ambroxolum oral drops, sol. 7,5mg/ml 50ml; 100ml Berlin-Chemie<br />

2050. Flavamed cough tablets Ambroxolum tab. 30mg N10; N20; N50 Berlin-Chemie<br />

2051. Flavamed hot cough-drink Ambroxolum efferv. tab. 30mg N10; N20; N40 Berlin-Chemie<br />

2052. Flavored Calcium Antacid<br />

Tablets ‘GAGA’<br />

Calcii carbonas tab. 500mg Perrigo<br />

2053. Flegamin Bromhexinum syrup 80mg/100ml 120ml Pliva Krakow<br />

2054. Flegamin Bromhexinum tab. 8mg<br />

N20<br />

2055. Flexen Ketoprofenum caps. 50mg,<br />

N30<br />

Pliva Krakow<br />

Italfarmaco /Scherer


EN<br />

206 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2056. Flexen Ketoprofenum powder and<br />

solvent for sol.<br />

for inj.<br />

Strength Manufacturer<br />

100mg/amp. +2,5ml amp.<br />

with solvent (Alcoholum<br />

benzylicum) N6<br />

Italfarmaco /<br />

Pharminvest<br />

2057. Flexen Ketoprofenum gel 2,5g/100g 50g Francia Farmaceutici-<br />

Industr.<br />

Farm.Biologia<br />

2058. Flexital Pentoxifyllinum film-coated<br />

sustainedrelease<br />

tab.<br />

400mg N100 Sun<br />

2059. Flexital Pentoxifyllinum sol. for inj. 20mg/ml 5ml; 15ml Sun<br />

2060. Flexital 100 Pentoxifyllinum film-coated tab. 100mg<br />

N60<br />

2061. Flixonase Fluticasoni propionas nasal spray,<br />

susp.<br />

2062. Flixonase Nasal Drops Fluticasoni propionas nasal drops,<br />

susp.<br />

2063. Flixotide 125 Inhaler Fluticasoni propionas aerosol,<br />

pressurised<br />

metered dose<br />

inhaler<br />

2064. Flixotide 25 Inhaler Fluticasoni propionas aerosol,<br />

pressurised<br />

metered dose<br />

inhaler<br />

2065. Flixotide 250 Inhaler Fluticasoni propionas aerosol,<br />

pressurised<br />

metered dose<br />

inhaler<br />

2066. Flixotide 50 Inhaler Fluticasoni propionas aerosol,<br />

pressurised<br />

metered dose<br />

inhaler<br />

2067. Flixotide Diskus Fluticasoni propionas inhalation<br />

powder<br />

2068. Flixotide Diskus Fluticasoni propionas inhalation<br />

powder<br />

2069. Flixotide Diskus Fluticasoni propionas inhalation<br />

powder<br />

2070. Flixotide Diskus Fluticasoni propionas inhalation<br />

powder<br />

2071. Flixotide Nebules Fluticasoni propionas susp.for inhal.<br />

by nebulisation<br />

2072. Flixotide Nebules Fluticasoni propionas susp.for inhal.<br />

by nebulisation<br />

Sun<br />

50µg/dose 120 doses Glaxo Wellcome<br />

400µg/ container (single dose)<br />

N28<br />

Glaxo Wellcome<br />

Australia<br />

125µg/dose 60doses Glaxo Wellcome<br />

25µg/dose 60doses Glaxo Wellcome<br />

250µg/dose 60doses Glaxo Wellcome<br />

50µg/dose 60doses Glaxo Wellcome<br />

500µg/dose 60doses Laboratoires Glaxo<br />

250µg/dose 60doses Laboratoires Glaxo<br />

100µg/dose 60doses Laboratoires Glaxo<br />

50µg/dose 60doses Laboratoires Glaxo<br />

0,5mg/2ml amp. N10 Glaxo Wellcome<br />

2mg/2ml amp. N10 Glaxo Wellcome<br />

2073. Flogofenac Diclofenacum supp. 100mg N10 Ecobi<br />

2074. Flogofenac Gel Diclofenacum gel 1g/100g 50g Ecobi<br />

2075. Flogofenac Retard Diclofenacum caps. 100mg N21 Ecobi<br />

2076. Floxet 10mg Fluoxetinum caps. 10mg N14 Egis


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 207<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2077. Fluanxol Flupentixolum tab. 1mg N50; N100 Lundbeck<br />

2078. Fluanxol Flupentixolum tab. 5mg N50; N100 Lundbeck<br />

2079. Fluanxol Flupentixolum tab. 0,5mg N50; N100 Lundbeck<br />

2080. Fluanxol Flupentixolum drops 100mg/ml 10ml Lundbeck<br />

2081. Fluanxol Depot cis(Z)-Flupentixoli decanoas sol. for inj. 100mg/ml N1; N10 Lundbeck<br />

2082. Fluanxol Depot cis(Z)-Flupentixoli decanoas sol. for inj. 20mg/ml 1ml N10; 2ml N10 Lundbeck<br />

2083. Fluarix 2002/2003 A/Moscow/10/99 (H3N2)<br />

atitinkanti˛ štama˛<br />

A/Panama/2007/99 (RESVIR-<br />

17)+A/New Caledonia/20/99<br />

(H1N1) atitinkanti˛ štama˛-<br />

A/New Caledonia/20/99(IVR-<br />

116)+B/Hong Kong/330/2001<br />

atitinkanti˛ štama˛-B/<br />

Shongdong/7/97<br />

susp. for inj. 15µg haemagglutinin+15µg<br />

haemagglutinin+15µg haemagglutinin/dose<br />

(0,5ml pre-filled<br />

syringe, with needle or without<br />

needle) N1; N10; N20<br />

2084. Flucinar Fluocinoloni acetonidum ointment 0,25mg/g<br />

15g<br />

2085. Flucinar Fluocinoloni acetonidum gel 0,25mg/g<br />

15g<br />

2086. Flucinar N Fluocinoloni acetonidum+<br />

Neomycini sulfas<br />

2087. Flucinar N Fluocinoloni acetonidum+<br />

Neomycini sulfas<br />

Sachsisches Serum<br />

Werk/<br />

GlaxoSmithKline<br />

Biologicals<br />

Jelfa<br />

Jelfa<br />

ointment 0,25mg+ 5mg/g 15g Jelfa<br />

cream 0,25mg+ 5mg/g 15g Jelfa<br />

2088. Fluconazol 150-Slovakofarma Fluconazolum caps. 150mg N1;N2 Slovakofarma<br />

2089. Fluconazol 50-Slovakofarma Fluconazolum caps. 50mg N7;N14 Slovakofarma<br />

2090. Fludara Fludarabinum sterile<br />

lyophilized<br />

solid cake for<br />

sol. for inj. or<br />

inf.<br />

50mg/vial<br />

N5<br />

Schering<br />

2091. Fludara oral Fludarabinum film-coated tab. 10mg N10; N15; N20; N25 Schering<br />

2092. Fluditec 2 % syrup for children<br />

and infants<br />

Carbocisteinum syrup 2g/100ml 125ml Innotech<br />

International<br />

2093. Fluditec 5 % syrup for adults Carbocisteinum syrup 5g/100ml 125ml Innotech<br />

International<br />

2094. Fluoraxan Fluorouracilum conc. for sol.<br />

for inf.<br />

2095. Fluoraxan Fluorouracilum conc. for sol.<br />

for inf.<br />

2096. Fluoraxan Fluorouracilum conc. for sol.<br />

for inf.<br />

250mg/5ml N12 Thissen<br />

500mg/10ml N6 Thissen<br />

1g/20ml N6 Thissen<br />

2097. Fluorouracil Fluorouracilum sol. for inj. 50mg/ml 5ml; 10ml N5 Abic for Teva<br />

2098. Fluoxetin Fluoxetinum caps. 20mg N30 Polpharma<br />

2099. Fluoxetine Lannacher Fluoxetinum caps. 20mg<br />

N20<br />

Lannacher


EN<br />

208 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2100. Fluoxetine-EGIS 20 mg Fluoxetinum caps. 20mg<br />

N14; N28<br />

Strength Manufacturer<br />

Siegfried<br />

2101. Flutan Flutamidum tab. 250mg N20;N50;N100 Medochemie<br />

2102. Fluval Fluoxetinum caps. 20mg N14;N28 KRKA<br />

2103. Flux Fluoxetinum caps., hard 20mg<br />

N14; N28<br />

2104. Folinoral 5mg Calcium folinate capsules 5mg Laboratories Thissen<br />

S.A.<br />

2105. Folio rūgšties<br />

5 mg tablete˙s<br />

2106. Folio rūgšties 0,8mg ir askorbo<br />

rūgšties 100 mg tablete˙s<br />

Salutas<br />

Acidum folicum tab. 5 mg N50 Liuks<br />

Acidum folicum+ Acidum<br />

ascorbicum<br />

tab. 0,8mg+ 100mg N20; N30;<br />

N50<br />

Bakteriniai<br />

preparatai<br />

2107. Folio rūgšties 5 mg tablete˙s Acidum folicum tab. 5mg N20; N50 Bakteriniai<br />

preparatai<br />

2108. Folio rūgštis Acidum folicum tab. 5mg<br />

N20; N50<br />

2109. Folio rūgštis ir vit. C Acidum folicum + Acidum<br />

ascorbicum<br />

tab. N30; N50 Liuks<br />

KMU vaistine˙<br />

2110. Food Paraffin Wax Paraffin wax subst. 25/25,4kg Schumann Sasol<br />

2111. Foradil Formoterolum dry pow- der<br />

caps. for inhal.<br />

2112. Forane Isofluranum inhalation<br />

liquid<br />

2113. Forceval capsules Betacarotenum+<br />

Ergocalciferolum+<br />

Thiaminum+ Riboflavinum+<br />

Pyridoxinum+<br />

Cyanocobalaminum+Acidum<br />

ascorbicum+ Tocopherolum+<br />

Biotinum+ Nicotinamidum+<br />

Acidum pantothenicum+<br />

Acidum folicum+ Calcium+<br />

Ferrum+ Cuprum+<br />

Phosphorus+ Magnesium+<br />

Kalium+Zincum+ Iodum+<br />

Manganum+ Selenium<br />

2114. Forceval Junior Capsules Betacarotenum+<br />

Ergocalciferolum+<br />

Thiaminum+ Riboflavinum+<br />

Pyridoxinum+<br />

Cyanocobalaminum+ Acidum<br />

ascorbicum+ Tocopherolum+<br />

Biotinum+ Nico-tinamidum+<br />

Acidum pantothenicum+<br />

Phytomenadionum+Acidum<br />

folicum+ Ferrum+Cuprum+<br />

Magnesium+ Zincum+Iodum+<br />

Manganum+ Selenium+<br />

Chromium<br />

12µg<br />

N30<br />

99,9% w/w 100ml; 250ml Abbott<br />

caps.,soft 2500IU+ 400IU+ 1,2mg+<br />

1,6mg+ 2mg+3µg+ 60mg+<br />

10mg+ 100µg+ 18mg+4mg+<br />

400µg+ 100mg+ 12mg+<br />

2mg+77mg+30mg+ 4mg+<br />

15mg+140µg+ 3mg+50µg+<br />

200µg+ 250µg N30; N90<br />

caps.,soft 1250IU+ 200IU+ 1,5mg+<br />

1mg+1mg+2µg+25mg+ 5mg+<br />

50µg+ 7,5mg+ 2mg+25µg+<br />

100µg+ 5mg+1mg+1mg+<br />

5mg+ 75µg+ 1,25mg+ 25µg+<br />

50µg+ 50µg N30<br />

Novartis Pharma<br />

Stein<br />

Unigreg<br />

Unigreg


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 209<br />

No. Commercial name General name<br />

2115. Forceval Protein Powder<br />

(chocolate flavour)<br />

2116. Forceval Protein Powder<br />

(naturalflavour)<br />

2117. Forceval Protein Powder<br />

(strawberry flavour)<br />

2118. Forceval Protein Powder<br />

(vanilla flavour)<br />

Retinolum+ Thiaminum+<br />

Riboflavinum+<br />

Nicotinamidum+ Acidum<br />

pantothenicum+ Pyridoxinum+<br />

Cyanocobalaminum +Acidum<br />

folicum+Acidum ascorbicum+<br />

Colecalciferolum+<br />

Tocopherolum+ Biotinum+<br />

Calcium+ Magnesium+<br />

Ferrum+ Zincum+<br />

Manganum+ Cuprum+<br />

Iodum+ Selenium+<br />

Chromium+ Molybdenum<br />

Retinolum+ Thiaminum+<br />

Riboflavinum+<br />

Nicotinamidum+ Acidum<br />

pantothenicum+ Pyridoxinum+<br />

Cyanocobalaminum+ Acidum<br />

folicum+Acidum ascorbicum+<br />

Colecalciferolum+<br />

Tocopherolum+ Biotinum+<br />

Calcium+ Magnesium+<br />

Ferrum+ Zincum+<br />

Manganum+ Cuprum+<br />

Iodum+ Selenium+<br />

Chromium+ Molybdenum<br />

Retinolum+ Thiaminum+<br />

Riboflavinum+<br />

Nicotinamidum+ Acidum<br />

pantothenicum+ Pyridoxinum+<br />

Cyanocobalaminum+ Acidum<br />

folicum+Acidum ascorbicum+<br />

Colecalciferolum+<br />

Tocopherolum+ Biotinum+<br />

Calcium+ Magnesium+<br />

Ferrum+ Zincum+<br />

Manganum+ Cuprum+Iodum<br />

+Selenium+ Chromium+<br />

Molybdenum<br />

Retinolum+ Thiaminum+<br />

Riboflavinum+<br />

Nicotinamidum+ Acidum<br />

pantothenicum+ Pyridoxinum+<br />

Cyanocobalaminum+ Acidum<br />

folicum+Acidum ascorbicum+<br />

Colecalciferolum+<br />

Tocopherolum+ Biotinum+<br />

Calcium+ Magnesium+<br />

Ferrum+ Zincum+<br />

Manganum+ Cuprum+Iodum+<br />

Selenium+ Chromium+<br />

Molybdenum<br />

Pharmaceutical<br />

form<br />

powder for oral<br />

sol.<br />

powder for oral<br />

sol.<br />

powder for oral<br />

sol.<br />

powder for oral<br />

sol.<br />

2119. Forlax Macrogolum 4 000 powder for oral<br />

sol.<br />

Strength Manufacturer<br />

2500IU+ 1,5mg+ 1,5mg+<br />

18mg+6mg+2mg+2µg+<br />

400µg+ 120mg+ 400IU+<br />

10mg+ 100µg+ 556mg+<br />

360mg+ 15mg+ 15mg+4mg+<br />

2,5mg+ 150µg+ 55µg+<br />

200µg+ 250µg+ 369mg+<br />

226mg+ 160mg+ 32g+21,6g+<br />

2,16g/72g N8<br />

2500IU+ 1,5mg+ 1,5mg+<br />

18mg+6mg+2mg+2µg+<br />

400µg+ 120mg+ 400IU+<br />

10mg+ 100µg+ 550mg+<br />

300mg+ 12mg+ 15mg+4mg+<br />

2mg+ 150µg+ 55µg+200µg +<br />

250µg+ 300mg+ 10mg+<br />

72mg+33g+18g+ 0,6g/60g N8<br />

2500IU+ 1,5mg+ 1,5mg+<br />

18mg+6mg+2mg+2µg+<br />

400µg+ 120mg+ 400IU+<br />

10mg+100µg+ 550mg+<br />

300mg+ 12mg+ 15mg+4mg+<br />

2mg+ 150µg+55µg+200µg+<br />

250µg+ 300mg+ 10mg+<br />

72mg+33g+18g+ 0,6g/60g N8<br />

2500IU+ 1,5mg+ 1,5mg+<br />

18mg+6mg+2mg+2µg+<br />

400µg+ 120mg+ 400IU+<br />

10mg+ 100µg+ 550mg+<br />

300mg+ 12mg+ 15mg+4mg+<br />

2mg+ 150µg+ 55µg+ 200µg+<br />

250µg+ 300mg+ 10mg+<br />

72mg+33g+18g+ 0,6g/60g N8<br />

Unigreg<br />

Unigreg<br />

Unigreg<br />

Unigreg<br />

10g/sachet N10; N20 Beaufour Ipsen<br />

2120. Formel 44 Husten-Löser Guaifenesinum sir. 200mg/15ml 120ml Procter & Gamble<br />

2121. Formel 44 Husten-Stiller Dextromethorphani<br />

hydrobromidum<br />

sir. 20mg/15ml 120ml Procter & Gamble<br />

2122. Fortovase Saquinavirum caps. 200mg N180 Scherer<br />

2123. Fortrans Macrogol 4000+ Anhydrous<br />

sodium sulfate+ Sodium<br />

bicarbonate+ Sodium<br />

chloride+ Potassium chloride<br />

powder for oral<br />

sol.<br />

64g+ 5,7g+ 1,68g+ 1,46g+<br />

0,75g/74g sachet N4<br />

Beaufour Ipsen


EN<br />

210 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2124. Fortum Ceftazidimum powder for sol.<br />

for inj.<br />

2125. Fortum Ceftazidimum powder for sol.<br />

for inj.<br />

2126. Fortum Ceftazidimum powder for sol.<br />

for inj.<br />

2127. Fortum Ceftazidimum powder for sol.<br />

for inj.<br />

2128. Fortum Ceftazidimum powder for sol.<br />

for inj.<br />

3g<br />

N1<br />

250mg<br />

vial N1<br />

500mg<br />

vial N1<br />

1g<br />

vial N1<br />

2g<br />

vial N1<br />

Strength Manufacturer<br />

Glaxo<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

2129. Fortwin Pentazocinum sol. for inj. 30mg/ml 1ml amp. N100 Ranbaxy<br />

2130. Fortzaar 100 mg/25 mg Losartanum+<br />

Hydrochlorothiazidum<br />

film-coated tab. 100mg+<br />

25mg N28<br />

2131. Fosamax Acidum alendronicum tab. 5mg N28 MSD<br />

2132. Fosamax Acidum alendronicum tab. 10mg N28 MSD<br />

2133. Fosamax (tablete˙s viena˛ karta˛<br />

per savaite˛)<br />

Acidum alendronicum tab. 70mg<br />

N2; N4<br />

2134. Fotil Pilocarpinum+ Timololum eye drops, sol. 20mg+<br />

5mg/ml 5ml<br />

2135. Fotil Pilocarpinum+ Timololum eye drops, sol. 20mg+ 5mg/ml single dose<br />

0,25ml N60<br />

2136. Fotil forte Pilocarpinum+ Timololum eye drops, sol. 40mg+ 5mg/ml single dose<br />

0,25ml N60<br />

2137. Fotil forte Pilocarpinum+ Timololum eye drops, sol. 40mg+ 5mg/ml 5ml Santen<br />

2138. Fragmin Dalteparinum natricum sol. for inj. 2 500 IU (anti-Xa)/0,2ml single<br />

dose syringe N10<br />

2139. Fragmin Dalteparinum natricum sol. for inj. 5 000 IU (anti-Xa)/0,2ml single<br />

dose syringe N10<br />

2140. Fragmin Dalteparinum natricum sol. for inj. 10 000 IU (anti-Xa)/ml 1ml<br />

amp.N10<br />

2141. Fragmin Dalteparinum natricum sol. for inj. 2 500 IU (anti-Xa)/ml<br />

4ml amp.N10<br />

2142. Fragmin Deltaparinum natricum solution for<br />

injection<br />

2143. Fragmin<br />

10 000 IU (anti-Xa)/<br />

0,4 ml<br />

2144. Fragmin<br />

12 500 IU (anti-Xa)/<br />

0,5 ml<br />

2145. Fragmin<br />

15 000 IU (anti-Xa)/<br />

0,6 ml<br />

2146. Fragmin<br />

18 000 IU (anti-Xa)/ 0,72 ml<br />

2147. Fragmin<br />

7 500 IU (anti-Xa)/<br />

0,3 ml<br />

MSD<br />

MSD<br />

Santen<br />

Santen<br />

Santen<br />

Pharmacia AB<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

10000 IU/ml 1ml syringe N10 Pharmacia AB<br />

Dalteparinum natricum sol. for inj. 10 000 IU (anti-Xa)/0,4ml<br />

pre-filled syringe N5<br />

Dalteparinum natricum sol. for inj. 12 500 IU (anti-Xa)/0,5ml<br />

pre-filled syringe N5<br />

Dalteparinum natricum sol. for inj. 15 000 IU (anti-Xa)/0,6ml<br />

pre-filled syringe N5<br />

Dalteparinum natricum sol. for inj. 18 000 IU (anti-Xa)/0,72ml<br />

pre-filled syringe N5<br />

Dalteparinum natricum sol. for inj. 7 500 IU (anti-Xa)/0,3ml<br />

pre-filled syringe N10<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 211<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2148. Framex Fluoxetinum caps. 20mg N14; N28 Gedeon Richter<br />

2149. Fraxiparine Nadroparinum calcicum sol. for inj. 5 700 IU(anti-Xa)/0,6ml<br />

pre-filled syringe N2;N10<br />

2150. Fraxiparine Nadroparinum calcicum sol. for inj. 9 500 IU(anti-Xa)/ml pre-filled<br />

syringe N2;N10<br />

2151. Fraxiparine Nadroparinum calcicum sol. for inj. 7 600 IU(anti-Xa)/0,8ml<br />

pre-filled syringe N2;N10<br />

2152. Fraxiparine Nadroparinum calcicum sol. for inj. 2 850 IU(anti-Xa)/0,3ml<br />

pre-filled syringe N2;N10<br />

2153. Fraxiparine forte Nadroparinum calcicum sol. for inj. 11 400 IU(anti-Xa)/0,6ml<br />

pre-filled syringe N2;N10<br />

2154. Fraxiparine forte Nadroparinum calcicum sol. for inj. 15 200 IU(anti-Xa)/0,8ml<br />

pre-filled syringe N2;N10<br />

2155. Fraxiparine forte Nadroparinum calcicum sol. for inj. 19 000 IU(anti-Xa)/ml<br />

pre-filled syringe N2;N10<br />

2156. Fromilid Clarithromycinum gran. for oral<br />

susp.<br />

2157. Fromilid 250 Clarithromycinum film-coated tab. 250mg<br />

N14<br />

2158. Fromilid 500 Clarithromycinum film-coated tab 500mg<br />

N14<br />

2159. Frontin Alprazolamum tab. 0,25mg<br />

N30; N100<br />

2160. Frontin Alprazolamum tab. 0,5mg<br />

N30; N100<br />

2161. Frontin Alprazolamum tab. 1mg<br />

N30; N100<br />

2162. Fruktoze˙s tablete˙s su vit. C (su<br />

vaisiu˛ aromatu)<br />

Fruktozum + Acidum<br />

ascorbicum<br />

2163. FSME-Bulin Tick-Borne Encephalitis<br />

Immunoglobulin human<br />

2164. FSME-Bulin Tick-Borne Encephalitis<br />

Immunoglobulin human<br />

2165. FSME-Bulin Tick-Borne Encephalitis<br />

Immunoglobulin human<br />

2166. FSME-IMMUN Inject Inactivated tick-borne<br />

encephalitis virus antigen<br />

125mg/5ml 25g (60ml) KRKA<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

KRKA<br />

KRKA<br />

Egis<br />

Egis<br />

Egis<br />

tab. N10 Liuks<br />

sol. for inj.i.m. 100-180mg/ml 10ml vial Baxter<br />

sol. for inj.i.m. 100-180mg/ml 5ml vial Baxter<br />

sol. for inj. i.m. 100-180mg/ml 2ml vial Baxter<br />

susp. for i.m.<br />

inj.<br />

2µg/0,5ml pre-filled syringe<br />

N1; N10<br />

2167. Ftorafurs Tegafurum caps. 400mg N10;100 Grindex<br />

2168. Ftorocort Triamcinolonum ointment 15mg/15g 15g tubele˙ Gedeon Richter<br />

2169. Fucicort Acidum fusidicum+<br />

Betamethasonum<br />

Baxter<br />

cream 20mg+1mg/g 15g Leo<br />

2170. Fucidin Natrii fusidas cream 20mg/g 15g Leo<br />

2171. Fucidin Natrii fusidas ointment 20mg/g 15g Leo<br />

2172. Fucidin Natrii fusidas powder and<br />

solvent for<br />

sol.for inf.<br />

500mg/vial +10ml sterile<br />

buffer solution N1<br />

Leo


EN<br />

212 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2173. Fucidin Acidum fusidicum oral susp. 50mg/ml 90ml Leo<br />

2174. Fucidin Natrii fusidas tab. 250mg N12 Leo<br />

2175. Fucidin H Acidum fusidicum+<br />

Hydrocortisoni acetas<br />

2176. Fucithalmic Acidum fusidicum viscous eye<br />

drops<br />

cream 20mg+ 10mg/g 15g Leo<br />

10mg/g 5g Leo<br />

2177. Fulsed 1mg/ml Midazolamum sol. for inj. 1mg/ml bottle 5ml ar 10ml<br />

N10<br />

Ranbaxy<br />

2178. Fulsed 5mg/ml Midazolamum sol. for inj. 5mg/ml 1ml amp. N10 Ranbaxy<br />

2179. Fungicon Acidum silicicum D6+<br />

Calendula officinalis ø+ Heckla<br />

lava D6+ Staphysagria D6 +<br />

Acidum hydrofluoricum D6<br />

ointment 0,5mg+10mg+ 10mg +<br />

10mg+ 0,5mg/g<br />

30g; 50g<br />

2180. Fungolon Fluconazolum caps. 100mg<br />

N16<br />

2181. Fungolon Fluconazolum caps. 50mg<br />

N8<br />

2182. Furacilino<br />

0,2 % tepalas<br />

Nitrofuralum ointment 2mg/g<br />

25g; 40g<br />

Aconitum<br />

Balkan-pharma-<br />

Razgrad<br />

Balkan-pharma-<br />

Razgrad<br />

2183. Furacilins Nitrofuralum tab. 100mg N20 OlainFarm<br />

2184. Furacilins Nitrofuralum subst. 1kg OlainFarm<br />

2185. Furadoninum Nitrofurantoinum tab. 50mg N20 OlainFarm<br />

2186. Furadoninum Nitrofurantoinum tab. 100mg N20 OlainFarm<br />

2187. Furamags 50mg Furaginum solubile capsules 50mg N30 JSC ‘Olaine<br />

Chemical-<br />

Pharmaceutical Plant’<br />

‘Olainfarm’<br />

2188. Furasol Furaginum solubilum+<br />

Natrii chloridum<br />

powder 0,1g+0,9g/sachet<br />

N15<br />

Sanitas<br />

Olainfarm<br />

2189. Furosemid Furosemidum sol. for inj. 20mg/2ml N5 Lannacher<br />

2190. Furosemid Furosemidum tab. 40mg<br />

N20; N50<br />

2191. Furosemid Furosemidum tab. 40mg<br />

N50<br />

Lannacher<br />

Balkanpharma-<br />

Dupnitza<br />

2192. Furosemid Furosemidum tab. 40mg N50 Polpharma<br />

2193. Furosemid Furosemidum sol. for inj. 20mg/2ml amp. N25 Polpharma<br />

2194. Furosemid Alpharma Tablets<br />

40 mg<br />

Furosemidum tab. 40mg<br />

N28; N50<br />

2195. Furozemido 0,04 tablete˙s Furozemidum tab. 0,04 N50 Liuks<br />

2196. Futura Ginkgo Biloba Ginkgo biloba f. extractum tab. 60mg<br />

N60; N120<br />

2197. Gabitril 10mg Tiagabinum film-coated<br />

scored tab.<br />

10mg<br />

N100<br />

Alpharma<br />

Dansk Droge<br />

Fawdon<br />

Manufacturing<br />

centre


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 213<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2198. Gabitril 15mg Tiagabinum film-coated<br />

scored tab.<br />

2199. Gabitril 5mg Tiagabinum film-coated<br />

scored tab.<br />

15mg<br />

N100<br />

5mg<br />

N100<br />

Strength Manufacturer<br />

Fawdon<br />

Manufacturing<br />

centre<br />

Fawdon<br />

Manufacturing<br />

centre<br />

2200. Galazolin Xylometazolinum nasal gel 0,5mg/g 5g; 10g Polfa Warsaw<br />

2201. Galazolin Xylometazolinum nasal gel 1mg/g 5g; 10g Polfa Warsaw<br />

2202. Galazolin<br />

0,1 %<br />

Xylometazolinum nasal drops, sol. 1mg/ml<br />

10ml<br />

Polfa Warsaw<br />

2203. Galazolin 0,05 % Xylometazolinum nasal drops, sol. 0,5mg/ml 10ml Polfa Warsaw<br />

2204. Galium-Heel compos. drops Heel<br />

2205. Gallemolan forte Extr. herb. Chelidonii sicc.+<br />

Extr. herb. Absinthii sicc.+Rad.<br />

Taraxici c. herba sicc.<br />

2206. Galstena compos. oral drops,<br />

solution<br />

(Ethanolum<br />

43%)<br />

2207. Gambrosol trio 10 Glucosum+ Natrii chloridum+<br />

Calcii chloridum+ Magnesii<br />

chloridum+ Natrii lactas<br />

2208. Gambrosol trio 40 Glucosum+ Natrii chloridum+<br />

Calcii chloridum+ Magnesii<br />

chloridum+ Natrii lactas<br />

2209. Gammagard S/D 10 g Human normal<br />

Immunoglobulin G<br />

2210. Gammagard S/D 2,5 g Human normal<br />

immunoglobulin G<br />

2211. Gammagard S/D 5 g Human normal<br />

Immunoglobulin G<br />

2212. Gardovit Vitaminum C (Lemon<br />

flavor)<br />

2213. Gardovit Vitaminum C<br />

(Orange flavor)<br />

caps. 100mg+40mg+20mg<br />

N40<br />

solution for<br />

peritoneal<br />

dialysis<br />

solution for<br />

peritoneal<br />

dialysis<br />

powder and<br />

solvent for sol.<br />

for inf.<br />

powder and<br />

solvent for sol.<br />

for inf.<br />

powder and<br />

solvent for sol.<br />

for inf.<br />

Acidum ascorbicum efferv. tab. 1000mg<br />

N10<br />

Acidum ascorbicum efferv. tab. 1000mg<br />

N10<br />

Redel<br />

20ml;50ml; 100ml Richard Bittner<br />

GmbH<br />

550g+5,38g+ 0,271g+<br />

0,054g+4,72g/ l 2000ml;<br />

2500ml; 3000ml; 5000ml<br />

550g+5,38g+ 0,209g+0,054g+<br />

4,72g/l 2000ml;2500ml;<br />

3000ml;5000ml<br />

10g/bottle+ 192ml water for<br />

inj.+ sterile transfer device+<br />

sterile administration set with<br />

filter N1<br />

2,5g/bottle+ 50ml water for<br />

inj.+ sterile transfer device+<br />

sterile administration set with<br />

a filter N1<br />

5g/bottle+ 96ml water for inj.+<br />

ste-rile transfer device+ sterile<br />

administration set with a filter<br />

N1<br />

Biosol S.p.A.<br />

Biosol S.p.A.<br />

Baxter<br />

Baxter<br />

Baxter<br />

N.P. Pharma<br />

N.P. Pharma<br />

2214. Garlic Tablets Allii sativi bulbus tab. 300mg N20;N60 Labofarm<br />

2215. Garlic+ Mistletoe+ Hawthorn+<br />

Vitamin E (Česnakas+<br />

Paprastasis amalas+ Gudobele˙+<br />

Vitaminas E)<br />

Ol.Allii sativi macer.+ Ol.Visci<br />

albi macer.+ Ol.Crataegi<br />

macer.+ Tocoferolum<br />

caps. 170mg+ 60mg+ 60mg+ 10mg<br />

N100<br />

Arco-Chemie<br />

2216. Garmastan Ointment Guaiazulen ointment 50mg/100g 20g Protina<br />

2217. Garstyčiu˛ pakeliai kompresams Sinapis saccinus pro<br />

compressibus<br />

powder 3g sachet N10; N20 Medicata Filia<br />

2218. Garstyčiu˛ paketas Sinapismus saccinus paketas N10 Sarepta


EN<br />

214 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2219. Garstyčiu˛ trauklapiai-paketai Sinapismus pulvis trauk-lapiaipaketai<br />

Strength Manufacturer<br />

2,9g/(100× 110)mm2 Kaigert<br />

2220. Gasec-10 Gastrocaps Omeprazolum capsules 10mg N14;N28 Mepha Ltd.<br />

2221. Gasec-20 Gastrocaps Omeprazolum caps. 20mg N7; N14; N28 Mepha<br />

2222. Gasec-40 Gastrocaps Omeprazolum capsules 40mg N14;N28 Mepha Ltd.<br />

2223. Gastal Aluminii hydroxidum-Magnesii<br />

carbonas+<br />

Magnesii hydroxidum<br />

2224. Gasterin Aluminii phosphas colloidalis+<br />

Pectinum<br />

2225. Gastricumeel Argentum nitricum D6+<br />

Acidum arse-nicosum D6+<br />

Pulsatilla pratensis D4+Nux<br />

vomica D4+ Carbo vegetabilis<br />

D6+ Antimonium crudum D6<br />

2226. Gastrocyne-sine Abies nigra 4 CH +Carbo<br />

vegetabilis 4 CH+ Nux vomica<br />

4 CH +Robinia pseudo acacia<br />

4CH<br />

2<strong>227</strong>. Gastrolit Natrii chloridum+ Kalii<br />

chloridum+ Natrii bicarbonas+<br />

Siccus Chamomillae extr.+<br />

Glucosum<br />

2228. Gastrovit (Gastrovitas) Bromelinum+<br />

Extr.Melissae+ Extr.Tauri+<br />

Extr.Condurangi+<br />

Extr.Gentianae+<br />

Extr.Harungani+Ol.Anisi<br />

2229. Gealcid Acidum alginicum+Natrii<br />

hydrogenocarbonas+ Aluminii<br />

hydroxidum<br />

tab. 450mg+ 300mg<br />

N60<br />

gel 1,2g+ 0,32g/16g pakeliuose po<br />

16g N20<br />

tab. 30mg+30mg+60mg+ 60mg+<br />

60mg+60mg<br />

N50<br />

tab. 0,75mg+ 0,75mg+ 0,75mg+<br />

0,75mg N60<br />

powder for oral<br />

sol.<br />

0,35g+0,3g+0,5g+0,1g+<br />

2,9g/4,15g (sachet)<br />

caps., soft 25mg+50mg+50mg+30mg+<br />

30mg+2,5mg+1mg<br />

N30<br />

2230. Geavir Aciclovirum eye ointment 30mg/g<br />

4,5g<br />

Pliva<br />

Slovako-farma<br />

Heel<br />

Boiron<br />

Polfa Kutno<br />

Arco-Chemie<br />

tablets 350mg+ 120mg+ 100mg N40 GlaxoSmith-Kline<br />

2231. Geavir Aciclovirum tab. 200mg N25 GEA<br />

2232. Geavir Aciclovirum tab. 800mg N35 GEA<br />

2233. Geavir Aciclovirum powder for inj. 125mg N5 GEA<br />

2234. Geavir Aciclovirum tab. 400mg N70 GEA<br />

2235. Geavir Aciclovirum powder for inj. 500mg<br />

N5<br />

2236. Geavir Aciclovirum powder for inj. 250mg<br />

N5<br />

2237. Gebeniu˛ ekstraktas Hederae helicis folium extr. 100 g Ethanolum ad 1 l 25ml,<br />

50 ml;<br />

100 ml<br />

2238. Gebeniu˛ sirupas Hederae helicis<br />

extractum<br />

2239. Gelofusine Succinylated gelatin +Sodium<br />

chloride+Sodium hydroxide<br />

syr. 100 ml;<br />

150 ml<br />

2240. Gelomyrtol Myrtol standardized enteric-coated<br />

caps.<br />

sol. for inf. 20g+3,51g+ 0,68g/500ml<br />

250ml;500ml; 1000ml<br />

120mg<br />

N20; N50; N100<br />

GEA<br />

GEA<br />

GEA<br />

Bakteriniai<br />

preparatai<br />

Bakteriniai<br />

preparatai<br />

Braun Melsungen<br />

Pohl-Boskamp


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 215<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2241. Gelomyrtol forte Myrtol standardized enteric-coated<br />

caps.<br />

2242. Gelsemium-Homaccord Gelsemium sempervirens D2+<br />

Gelsemium sempervirens<br />

D10+ Gelsemium<br />

sempervirens D30+Gelsemium<br />

sempervirens D200+Rhus toxicodendron<br />

D3+ Rhus<br />

toxicoden-dron D10+Rhus<br />

toxicodendron D30+Rhus<br />

toxicodendron D200+<br />

Cimifuga racemosa D2<br />

2243. Gemzar Gemcitabinum powder for sol.<br />

for inf.<br />

2244. Gemzar Gemcitabinum powder for sol.<br />

for inf.<br />

300mg<br />

N20; N50; N100<br />

Strength Manufacturer<br />

drops 0,4g+0,4g+ 0,4g+0,4g+ 0,3g+<br />

0,3g+ 0,3g+0,3g+ 0,3g+0,3g+<br />

0,3g+ 0,3g/100g (Ethanolum<br />

35 vol.-%) 30ml;100ml<br />

200mg/vial<br />

N1<br />

1g/vial<br />

N1<br />

2245. Gencijonu˛ tinktūra Gentianae radix tinct. 200 g Ethanolum ad 1 l 50 ml;<br />

100 ml<br />

2246. Genotropin Somatropinum powder and<br />

solvent for sol.<br />

for inj.,twocompartment<br />

cartridges<br />

2247. Genotropin Somatropinum powder and<br />

solvent for sol.<br />

for inj.,twocompartment<br />

cartridges<br />

36IU (12mg) cartridges<br />

N1; N5<br />

16IU (5,3mg) cartridges<br />

N1; N5<br />

2248. Gentamicin Gentamicinum sol. for inj. 80mg/2ml amp. N10 KRKA<br />

2249. Gentamicin Gentamicinum sol. for inj. 40mg/ml<br />

1ml amp. N10<br />

Pohl-Boskamp<br />

Heel<br />

Lilly France<br />

Lilly France<br />

Bakteriniai<br />

preparatai<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

2250. Gentamicin Gentamicinum sol. for inj. 80mg/2ml amp. N10 Polfa Tarchomin<br />

2251. Gentamicin Gentamicinum sol. for inj. 40mg/2ml amp. N10 Polfa Tarchomin<br />

2252. Gentamicin Gentamicinum sol. for inj. 80mg/2ml amp. N25 Chinoin<br />

2253. Gentamicin ‘Biochemie’ 40 mg<br />

ampoules<br />

2254. Gentamicin ‘Biochemie’ 80 mg<br />

ampoules<br />

KRKA<br />

Gentamicinum sol. for inj. 40mg/ml N50 Hafslund Nycomed<br />

Gentamicinum sol. for inj. 80mg/2ml N50 Hafslund Nycomed<br />

2255. Gentamicin 0,1 % cream Gentamicinum cream 1mg/g 15g Balkanphar-ma-<br />

Razgrad<br />

2256. Gentamicin 0,1 % ointment Gentamicinum ointment 1mg/g 15g Balkanphar-ma-<br />

Razgrad<br />

2257. Gentamicin 0,3 % Gentamicinum eye drops, sol. 3mg/ml<br />

5ml<br />

2258. Gentamicin 0,3 % eye<br />

ointment<br />

Polfa Warsaw<br />

Gentamicinum eye ointment 3mg/g 5g Balkanphar-ma-<br />

Razgrad<br />

2259. Gentamicin Sopharma Gentamicinum sol. for inj. 80mg/2ml amp. N10 Sopharma PLC<br />

2260. Gentamicin Sopharma Gentamicinum sol. for inj. 40mg/ml amp. N10 Sopharma PLC<br />

2261. Gentamicino sulfato 0,3 %<br />

tirpalas akiu˛ lašai<br />

Gentamicinum eye drops sol. 3mg/ml<br />

1,5ml N4<br />

Endokrini-niai<br />

preparatai


EN<br />

216 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

2262. Gentamicino sulfato 4 %<br />

tirpalas injekcijoms<br />

2263. Gentamicino sulfato 4 %<br />

tirpalas injekcijoms<br />

2264. Gentos Populus D1+ Sabal D6+<br />

Conium D6+ Kalium jodatum<br />

D12+Ferrum picrinicum D12<br />

(Ethanolum 43% 0,53ml/ml)<br />

2265. Geriavit Pharmaton Extractum concentratum<br />

normatum Panax ginseng radix<br />

+Dimethylamino-ethanoli<br />

hydrogenotartras+ Retinolum+<br />

Thiaminum+ Riboflavinum+<br />

Pyridoxinum+<br />

Cyanocobalaminum+ Acidum<br />

ascorbicum +<br />

Ergocalciferolum+<br />

Tocopherolum+<br />

Nicotinamidum+Calcii<br />

pantothenas+Rutosidum+<br />

Fluorinum<br />

2266. Gerimax Ginseng Sausas Zˇenšenio šaknies<br />

ekstraktas<br />

2267. Geritamin Retinolum+<br />

Tocopherolum<br />

Pharmaceutical<br />

form<br />

Gentamicinum sol. for inj. 40mg/ml<br />

2ml amp.N10<br />

Gentamicinum sol. for inj. 40mg/ml<br />

1ml; 2ml amp. N10<br />

oral drops, sol. 0,07ml+ 0,1ml+ 0,1ml+<br />

0,1ml+ 0,1ml/1ml 20ml;<br />

50ml; 100ml<br />

caps., soft 40mg+26mg+4 000UI +2mg+<br />

2mg+1mg+1µg+ 60mg+<br />

400UI+10mg+ 15mg+10mg+<br />

20mg+ 0,2mg<br />

N30; N100<br />

Strength Manufacturer<br />

Sanitas<br />

Endokrini-niai<br />

preparatai<br />

Richard Bittner<br />

Pharmaton<br />

mixt. 200mg/15ml 250ml Dansk Droge<br />

soft caps. 30 000 UI+<br />

70mg N40<br />

2268. Gero miego kapsule˙s Compositus caps. Sanitas<br />

2269. Gero miego lašai Compositus tinct. Sanitas<br />

<strong>227</strong>0. Gincosan Pharmaton Standardized Panax ginseng<br />

extract+ Standardized Ginkgo<br />

biloba extract<br />

caps., hard 100mg+60mg N4; N10; N30;<br />

N60<br />

<strong>227</strong>1. Ginkgo AC Ginkgo Biloba dry extr. caps. 60 mg<br />

N15;N30; N60<br />

<strong>227</strong>2. Ginkgo AC forte Ginkgo Biloba dry extr. caps. 120 mg<br />

N20; N40<br />

<strong>227</strong>3. Ginkmedzˇio lapai Fol.Ginkgo bilobae tea 1,5g<br />

N25<br />

<strong>227</strong>4. Ginkomed Ginkgo folium+Ethanolum<br />

70 % (V/V)<br />

<strong>227</strong>5. Ginkor Extr.Ginkgo bilobae+<br />

Troxerutinum<br />

<strong>227</strong>6. Ginkor Fort Extr.Ginkgo bilobae+<br />

Troxerutinum+ Heptaminolum<br />

tinct. (1:5) 200g +ad praeparationibus 1l<br />

tincturae 25ml; 50ml; 100ml<br />

Balkanpharma-<br />

Troyan<br />

Pharmaton<br />

Hasco-Lek/ Acorus<br />

Calamus<br />

Hasco-Lek/ Acorus<br />

Calamus<br />

Acorus Calamus<br />

Bakteriniai<br />

preparatai<br />

gel 0,14g+ 3g/100g 40g Beaufour Ipsen<br />

caps. 14mg+ 300mg+ 300mg N30 Beaufour Ipsen<br />

<strong>227</strong>7. Ginsana capsules Extr. Ginsengi caps., soft 100mg N30; N100 Pharmaton<br />

<strong>227</strong>8. Ginsana tonic Extr. Ginsengi (Ethanolum<br />

96 % 96,7mg/ml)<br />

liq. 9,333mg/ml 100ml; 250ml Pharmaton<br />

<strong>227</strong>9. Ginsana tonic without alcohol Extr. Ginsengi liq. 9,33mg/ml 100ml; 250ml Pharmaton<br />

2280. Glibenklamido<br />

5 mg tablete˙s<br />

Glibenclamidum tab. 5 mg N10; N100; N120 Liuks


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 217<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2281. Glicerolis 85% Glycerolum sol. 85g/100g 50g KMA vaistine˙<br />

2282. Glikoze 10% Glucosum sol. for inf. 10g/100ml (100ml; 250ml;<br />

500ml; 1000ml plastic bags<br />

with shelf-life 3 year); 250ml;<br />

500ml; 1000ml ‘Propyflex’<br />

with shelf-life 2 year<br />

2283. Glikoze 20% Glucosum sol. for inf. 20g/100ml (100ml; 250ml;<br />

500ml; 1000ml plastic bags<br />

with 3 year shelf-life); 250ml;<br />

500ml;1000ml ‘Propyflex’ with<br />

2 year shelf-life<br />

2284. Glikoze 25% Glucosum sol. for inf. 25g/100ml (100ml; 250ml;<br />

500ml; 1000ml plastic bags<br />

with 3 year shelf-life); 500ml<br />

‘Propyflex’ with 2 year<br />

shelf-life<br />

2285. Glikoze 5% Glucosum sol. for inf. 5g/100ml (100ml; 250ml;<br />

500ml; 1000ml plastic bags<br />

with shelf-life 3 year); 250ml;<br />

500ml; 1000ml ‘Propyflex’<br />

with shelf-life 2 year<br />

2286. Glimidstada 1,75 Glibenclami-dum tab. 1,75mg<br />

N30; N120<br />

2287. Glimidstada 3,5 Glibenclami-dum tab. 3,5mg<br />

N30; N120<br />

2288. Glipizide BP Glipizidum tab. 5 mg N30 Liuks<br />

2289. Gliukoze˙s<br />

40 % tirpalas injekcijoms<br />

2290. Gliukoze˙s<br />

10 % tirpalas infuzijoms<br />

2291. Gliukoze˙s<br />

40 % tirpalas injekcijoms<br />

2292. Gliukoze˙s<br />

5 % tirpalas infuzijoms<br />

2293. Gliukoze˙s tablete˙s (su vaisiu˛<br />

aromatu)<br />

Glucosum anhydricum sol. for inj. 400mg/ml 5ml; 10ml amp.<br />

N10<br />

Glucosum anhydricum sol. for inf. 100g/ 1000ml 100ml; 250ml;<br />

500ml; 1000ml<br />

Grindeks<br />

Grindeks<br />

Grindeks<br />

Grindeks<br />

Stada<br />

Stada<br />

Endokrini-niai<br />

preparatai<br />

Ilsanta<br />

Glucosum anhydricum sol. for inj. 400mg/ml N5; N10 Sanitas<br />

Glucosum anhydricum sol. for inf. 50g/1000ml 100ml; 250ml;<br />

500ml;<br />

1 000ml<br />

Glucosum tab. N10 Liuks<br />

Ilsanta/ Fresenius<br />

Kabi Polska<br />

2294. Gliukoze˙s tablete˙s MDF Glucosum tab. 2650 mg N10 Medicata filia<br />

2295. Gliukoze˙s tablete˙s su vit. C (su<br />

vaisiu˛ aromatu)<br />

2296. Glivec<br />

100 mg<br />

Glucosum +Acidum<br />

ascorbicum<br />

Imatinibum caps., hard 100mg<br />

N120<br />

2297. Glivec 50 mg Imatinibum caps., hard 50mg<br />

N30<br />

2298. GlucaGen 1mg HypoKit Glucagonum powder and<br />

solvent for sol.<br />

for inj.<br />

2299. Glucagon Emergency Kit for<br />

Diabetic Insulin Reaction<br />

Glucagonum powder and<br />

solvent for sol.<br />

for inj.<br />

tab. N10 Liuks<br />

1mg N1(vial and syringe with<br />

solvent)<br />

1mg N1(vial with powder and<br />

vial with solvent)<br />

Novartis Pharma<br />

Novartis Pharma<br />

Novo Nordisk<br />

Eli Lilly


EN<br />

218 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

2300. Glucosa<br />

10 % pro infusionibus<br />

2301. Glucosa<br />

20 % pro infusionibus<br />

2302. Glucosa<br />

40 % pro infusionibus<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

Glucosum monohydricum sol. for inf. 10g/100ml 500ml Balkanphar-ma-<br />

Troyan<br />

Glucosum monohydricum sol. for inf. 20g/100ml 500ml Balkanphar-ma-<br />

Troyan<br />

Glucosum monohydricum sol. for inf. 40g/100ml 500ml Balkanphar-ma-<br />

Troyan<br />

2303. Glucosa 5 % pro infusionibus Glucosum monohydricum sol. for inf. 5g/100ml 500ml Balkanphar-ma-<br />

Troyan<br />

2304. Glucose<br />

10 % Braun<br />

Glucosum sol. for inf. 100g/1000ml 250ml; 500ml;<br />

1000ml<br />

2305. Glucose Glucosum powder 80g bag Galenus<br />

2306. Glucose<br />

20 % Intravenous Solution For<br />

Infusion<br />

Glucosum monohydricum sol. for inf. 220mg/ml 500ml Ilsanta<br />

2307. Glucose 5 % Braun Glucosum sol. for inf. 50g/1000ml 250ml; 500ml;<br />

1000ml<br />

2308. Glucose 5 % Braun Glucosum sol. for inj. 0,5g/10ml polyethylene amp.<br />

N20<br />

2309. Glucose 5 % Braun Glucosum sol. for inj. 5g/100ml 50ml, 100ml glass<br />

vials N20<br />

2310. Glucosum 10% Glucosum sol. for inf. 10g/100ml 100ml; 250ml;<br />

500ml<br />

2311. Glucotrol XL Glipizidum osmotic tab. 5mg N30 Pfizer<br />

2312. Glucotrol XL Glipizidum osmotic tab. 10mg N30 Pfizer<br />

Braun Melsungen<br />

Braun Melsungen<br />

Braun Melsungen<br />

Braun Melsungen<br />

Polfa Kutno<br />

2313. Glurenorm Gliquidonum tab. 30mg N60 Boehringer<br />

Ingelheim<br />

2314. Glyboral Glibenclamidum tab. 5mg N100 USV Limited<br />

2315. Glycerol Glycerolum subst. 99,5% Karlshamns Tefac<br />

2316. Glycerolum 86 % Glycerolum liquidum 86% 30g; 1kg; 5kg; 10kg Hasco-Lek<br />

2317. Glycin Ethanol Glycin+Ethanol 96% irrigation sol. 15g+10,7g/1l 3l Baxter<br />

2318. Glycomet-500 Metforminum tab. 500mg N100 USV Limited<br />

2319. Glycomet-850 Metforminum film-coated<br />

tablets<br />

2320. Glycophos Natrii glycerophosphas additive for<br />

infusion fluids<br />

2321. Glytrin Spray Glyceroli trinitras metered dose<br />

(sublingnal)<br />

spray, solution<br />

2322. Gold Seal-Pharma (ZnO) Zinci oxidum Eur. Ph., USP,<br />

DAB<br />

850mg N100 USV Limited<br />

216mg/ml 20ml vials N10 Fresenius Kabi Norge<br />

for Fresenius Kabi<br />

Sweden<br />

0,4mg/dose 200 doses Bioglan Laboratories<br />

Limited<br />

subst. 25kg De Craene<br />

2323. Golden Star compos. balsam 3g;4g;10g;14g Central<br />

Pharmaceutical<br />

Factory 26-OPC


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 219<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2324. Gonal-F 37,5 Follitropinum alfa powder and<br />

solvent for sol.<br />

for inj.<br />

2325. Gonal-F Follitropinum alfa powder and<br />

solvent for sol.<br />

for inj.<br />

2326. Gopten Trandolaprilum caps., hard 0,5mg<br />

N20<br />

2327. Gopten Trandolaprilum caps., hard 2mg<br />

N28<br />

Strength Manufacturer<br />

37,5 UI/amp. +1ml amp. of<br />

solvent (Aqua ad iniectabilia)<br />

N1; N3;N10<br />

Serono<br />

75 IU/amp. N1; N3; N10 Serono<br />

2328. Gordox Aprotininum sol. for inj. 10 000 KIU/ml 10ml amp.<br />

N25<br />

2329. Gordox<br />

500 000 KIU/ 50 ml solution<br />

for infusion<br />

2330. Gracial Desogestrelum+<br />

Ethinylestradiolum<br />

Knoll<br />

Knoll<br />

Gedeon Richter<br />

Aprotininum sol. for inf. 500 000 KIU/50ml bottle N10 Gedeon Richter<br />

tab. blue tab.: 0,025mg+ 0,04mg;<br />

white tab.: 0,125mg+ 0,03mg<br />

N22; N66; N132<br />

2331. Grandaxin tablets Tofisopamum tab. 50mg N20 Egis<br />

2332. Granocyte 34 Lenograstimum powder and<br />

solvent for sol.<br />

for inj.<br />

2333. Graphites-Homaccord Graphites D10 + Graphites<br />

D30+ Graphites D 200 +<br />

Calcium carbonicum<br />

Hahnemanni D10+Calcium<br />

carbonicum Hahnemanni<br />

D30+ Calcium carbonicum<br />

Hahnemanni D200<br />

2334. Gravinova Calcium+ Phosphorus+<br />

Fluoridum+ Magnesium+<br />

Ferrum+ Zincum+ Retinolum+<br />

Colecalciferolum +<br />

Tocopherolum+ Thiaminum+<br />

Riboflavinum+ Pyridoxinum+<br />

Cyanocobalaminum+<br />

Nicotinamidum+ Calcii<br />

pantothenas+ Acidum<br />

folicum+ Acidum ascorbicum<br />

33,6MIU (263µg)/vial N5<br />

(solvent: 1ml pre-filled<br />

syringe/amp.)<br />

drops 0,5g+0,5g+ 0,5g+0,5g+ 0,5g+<br />

0,5g/100g (Ethanolum 35<br />

tūrio %) bottle 30ml; 100ml<br />

granulate for<br />

oral sol.<br />

2335. Grinvitals Cereloba Tabletes Extr. Ginkgo bilobae tab. 30,4mg<br />

N60<br />

2336. Grinvitals zˇenšena Retinol+Colecalciferol+<br />

Thiamin+ Riboflavin+Nicotinic<br />

ac.+Pyridoxine+<br />

Cyanocobalamin+ Ascorbic<br />

ac.+ Calcium pant.+<br />

Tocoferol+Folic ac. +Ferrous<br />

fumar.+<br />

Zinc oxide+Copper carb.+<br />

Iodine+ Molybdenum+<br />

Chromium+ Magnesium+<br />

Ginseng+Calcium phosp. +<br />

Microcellulose+ Magnesium<br />

400mg+ 300mg+ 0,3mg+<br />

5mg+ 8mg+ 1mg+ 1000IU+<br />

100IU+ 4mg+ 0,5mg+ 0,5mg+<br />

0,8mg+ 1,5µg+ 6mg+ 3,5mg+<br />

0,25mg+ 20mg/30g 90g<br />

tab. 1800IU+180IU+2,6mg+ 3mg+<br />

21mg+4,7mg+ 6,3µg+115mg+<br />

10,5mg+ 45mg+0,21mg+<br />

55mg+19mg+<br />

8,6mg+ 5,3mg +0,15mg+<br />

0,25mg+15µg+46mg+ 10mg+<br />

181,54mg+ 90mg + 7,2mg<br />

N30<br />

Organon<br />

Chugai<br />

Pharmaceutical Co.<br />

Heel<br />

KRKA<br />

Legosan<br />

Legosan/ Grindex


EN<br />

220 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

2337. Gripex Paracetamolum+<br />

Pseudoephedrinum+<br />

Dextramethorphanum<br />

2338. Gripp-Heel Aconitum D4 + Bryonia D4 +<br />

Lachesis D12 + Eupatorium<br />

perfoliatum D3+Phosphorus<br />

D5<br />

2339. Grippostad C Paracetomolum+ Acidum<br />

ascorbicum+ Coffeinum+<br />

Chlorphenaminum<br />

2340. Grippostad Good Night Liquid Dextromethorphanum+<br />

Paracetamolum (Ethanolum<br />

18%)<br />

Pharmaceutical<br />

form<br />

2341. Grippostad karštasis ge˙rimas Paracetamolum Hot drink,<br />

powder for oral<br />

sol.<br />

coated tab. 325mg+30mg+10mg<br />

N12<br />

tab. 120mg+60mg+60mg+<br />

30mg+30mg N50;N250<br />

caps. 200mg+ 150mg+ 25mg+<br />

2,5mg N20<br />

oral sol. 15mg+ 600mg/30ml 90ml;<br />

180ml<br />

Strength Manufacturer<br />

US Pharmacia<br />

Heel<br />

Stada<br />

Stada<br />

600mg/5g sachets N10 Stada<br />

2342. Griseofulvin Griseofulvinum tab. 0,125g N10, N20, N50 Liuks<br />

2343. Groseptol Sulfamethoxazolum+<br />

Trimethoprimum<br />

2344. Groseptol Sulfamethoxazolum+<br />

Trimethoprimum<br />

2345. Grovit Multivitamin Drops Acidum ascorbicum+<br />

Tocopherolum+<br />

Colecalciferolum+<br />

Dexpanthenolum+<br />

Nicotinamidum+<br />

Pyridoxinum+ Riboflavinum+<br />

Thiaminum+ Retinolum<br />

2346. Grovit Syrup Acidum ascorbicum+<br />

Thiaminum+ Pyridoxinum+<br />

Nicotinamidum+<br />

Riboflavinum+<br />

Dexpanthenolum+<br />

Cyanocobalaminum+<br />

Colecalciferolum+ Retinolum+<br />

Citrus bioflavonoid compound<br />

tab. 400mg+80mg N20 Polfa Grodzisk<br />

tab. 100mg+20mg N20 Polfa Grodzisk<br />

drops 40mg+5mg+400IU+3mg+<br />

10mg+1mg+1mg+2mg+<br />

3000IU/ 0,6ml 15ml<br />

syrup 50mg+2mg+1mg+15mg+<br />

1mg+2,5mg+1µg+200IU+<br />

2500IU+ 5mg/5ml 100ml<br />

2347. Gudobele˙s tinktūra Fruct. Crataegi tinct. 100g (Ethanolum 70 % ad 1l)<br />

25ml; 19kg<br />

2348. Gudobele˙s tinktūra Crataegi fructus tinct. 100g (Ethanolum 70% ad 1l)<br />

25ml<br />

2349. Gudobele˙s tinktūra Crataegi fructus liq. 100g (Ethanolum 70% ad<br />

1000ml) 25ml<br />

USV<br />

USV<br />

Sanitas<br />

Vilniaus f.f.<br />

Bakteriniai<br />

preparatai<br />

2350. Gudobeliu˛ vaisiai Fruct. Crataegi herbal tea 50g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

2351. Gudobeliu˛ vaisiai Fruct.Crataegi 50g;100g Švenčioniu˛<br />

vaistazˇole˙s<br />

2352. Gutron 1% drops Midodrini hydrochloridum oral drops, sol. 10mg/ml<br />

25ml<br />

2353. Gutron 2,5mg tablets Midodrini hydrochloridum tab. 2,5mg<br />

N20<br />

Nycomed Austria<br />

Nycomed Austria


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 221<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2354. Guttalax Natrii picosulfas oral sol. 7,5mg/ml 15ml;30ml Boehringer<br />

Ingelheim<br />

2355. Gynäcoheel Apis mellifica D4 +Helonias<br />

dioica D4+Melilotus officinalis<br />

D3+ Ammonium bromatum<br />

D4+Lilium tigrinum D4+<br />

Aurum jodatum D12 +<br />

Palladium metallicum D12+<br />

Platinum metallicum D12+<br />

Naja naja D12+Vespa crabro<br />

D4+Viburnum opulus D2<br />

2356. Gynalgin Chlorquinaldolum+<br />

Metronidazolum<br />

drops 10g+10g+5g+10g+10g+ 10g+<br />

10g+ 10g+10g+ 10g+5g/100g<br />

(Ethanolum 35 % (V/V)) 30ml<br />

vaginal tab. 100mg +250mg<br />

N10<br />

2357. Gynipral Hexoprenalini sulfas tab. 0,5mg<br />

N20<br />

2358. Gynipral 10mcg/2ml-<br />

Ampoules<br />

2359. Gynipral 25mcg-concentrate<br />

for the preparation of<br />

infusions<br />

Heel<br />

ICN Polfa Rzeszow<br />

Nycomed Austria<br />

Hexoprenalini sulfas sol. for inj./inf. 10µg/2ml amp. N5 Nycomed Austria<br />

Hexoprenalini sulfas concentrate for<br />

sol. for inf.<br />

25µg/5ml amp. N5 Nycomed Austria<br />

2360. Gyno-Daktarin Miconazolum ovules 100mg N15 Janssen<br />

2361. Gynodian Depot Prasteroni enantas+ Estradioli<br />

valeras<br />

sol. for inj. 200mg+ 4mg/ml 1ml<br />

pre-filled syringe N1<br />

2362. Gyno-Pevaryl 150 Econazoli nitras vaginal ovules 150mg<br />

N3<br />

2363. Gyno-Pevaryl 150 Combipack Econazoli nitras vaginal ovules;<br />

vaginal cream<br />

2364. Gyno-Pevaryl 50 Econazolum vaginal ovules 50mg<br />

N15<br />

150mg; 10mg/g<br />

N3 ovules; 15g cream<br />

Schering<br />

2365. Gyno-Travogen Isoconazoli nitras ovule 600mg and 2 finger stalls N1 Boehringer<br />

Ingelheim Italia<br />

2366. Haemoctin SDH 1000 Human plasma fraction<br />

enriched with blood clotting<br />

factor VIII<br />

2367. Haemoctin SDH 250 Human plasma fraction<br />

enriched with blood clotting<br />

factor VIII<br />

2368. Haemoctin SDH 500 Human plasma fraction<br />

enriched with blood clotting<br />

factor VIII<br />

powder and<br />

solvent for<br />

sol.for inj.<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

Cilag<br />

Cilag<br />

Cilag<br />

1000IU/vial N1 Biotest<br />

250IU/vial+ vial (5ml) with<br />

water for inj.+disposable<br />

syringe (5ml)+double-ended<br />

cannula+filter needle+ butterfly<br />

cannula N1<br />

Biotest<br />

500IU/vial N1 Biotest<br />

2369. Halcion Triazolamum tab. 0,125mg N10 Pharmacia & Upjohn<br />

Caribe<br />

2370. Halcion Triazolamum tab. 0,25mg<br />

N10<br />

2371. Halixol Ambroxolum syrup 0,3g/100ml 100ml Egis<br />

2372. Halixol Ambroxolum tab. 30mg N20 Egis<br />

2373. Haloper Haloperidolum tab. 10mg N10; 30;50;100 CTS<br />

2374. Haloper Haloperidolum tab. 0,5mg N10; 30;50;100 CTS<br />

Pharmacia & Upjohn<br />

Caribe


EN<br />

222 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2375. Haloper Haloperidolum tab. 1,5mg N10; 30;50;100 CTS<br />

2376. Haloper Haloperidolum tab. 5mg N10; 30;50;100 CTS<br />

2377. Haloperidol Haloperidolum tab. 1mg<br />

N40<br />

Polfa Warsaw<br />

2378. Haloperidol Haloperidolum sol. for inj. 5mg/ml 1ml amp.N10;N50 Polfa Warsaw<br />

2379. Haloperidol Haloperidolum tab. 1,5mg<br />

N50<br />

2380. Haloperidol Haloperidolum tab. 5mg<br />

N50<br />

Gedeon Richter<br />

Gedeon Richter<br />

2381. Haloperidol Haloperidolum sol. for inj. 5mg/ml 1ml amp. N5 Gedeon Richter<br />

2382. Haloperidol Haloperidolum drops 2mg/ml<br />

10ml<br />

2383. Haloperidol Decanoate-Richter Haloperidolum sol. for inj. 50mg/ml<br />

1ml amp.N1; N5<br />

2384. Hamamelis-Homaccord Hamamelis virginiana D2+<br />

Hamamelis virginiana D30+<br />

Hamamelis virginiana D200+<br />

Carduus marianus D6+<br />

Carduus marianus D30+<br />

Carduus marianus D200<br />

oral drops 800mg+ 800mg+ 800mg+<br />

200mg+ 200mg+ 200mg/<br />

100g 30ml;100ml<br />

2385. Hamamelis-Salbe-Heel S Hamamelis virginiana Ø ointment 10g/100g 50g Heel<br />

2386. Hamatopan 100 Ferrosi sulfas drag. 272mg N20; N50; N100 Wolff<br />

2387. Hamatopan 50 Ferrosi sulfas drag. 136mg N20; N50; N100 Wolff<br />

2388. Hansaplast ABC šildomasis<br />

pleistras<br />

2389. Hansaplast ABC šildomasis<br />

tepalas<br />

Capsaicinoids medicated<br />

plaster<br />

Diethylamini salicylas+<br />

Benzylis nicotinas+<br />

Nonivamidum<br />

2390. Harmonet Gestodenum+<br />

Ethinylestradiolum<br />

Gedeon Richter<br />

Gedeon Richter<br />

Heel<br />

11mg / plaster 1 sachet Beiersdorf AG<br />

ointment 5g+2g+ 0,3g/100g 50g Beiersdorf<br />

tab. 0,075mg+ 0,02mg N21; N63 Wyeth Medica<br />

2391. Havrix 1440 ELISA U/ml Inactivated hepatitis A antigen susp. for inj. 1440 ELISA U/ml 1ml vial N1 SmithKline<br />

Beecham/<br />

Sachsische<br />

Serumwerk<br />

2392. Havrix 1440 ELISA U/ml Inactivated hepatitis A antigen susp. for inj. 1440 ELISA U/ml 1ml<br />

pre-filled syringe N1<br />

2393. Havrix 720 Junior Inactivated hepatitis A antigen susp. for inj. 720 ELISA U/0,5ml pre-filled<br />

syringe N1<br />

2394. Hedelix Hustensaft Extr. Hederae helicis spiss.<br />

(1:1)<br />

SmithKline<br />

Beecham/ Sachsische<br />

Serumwerk<br />

SmithKline<br />

Beecham/ Sachsische<br />

Serumwerk<br />

sir. 2g/100ml 100ml; 200ml Krewel Meuselbach<br />

2395. Hedelix s.a. Extr. Hederae helic. spiss. (1:1) oral drops, sol. 10g/100ml 20ml; 50ml;<br />

100ml<br />

2396. Hedelix Tropfen Extr. Hederae helicis fluidum<br />

(1:10)<br />

oral drops, sol. 940mg/ml (Ethanolum 45%)<br />

50ml<br />

2397. Helarium Hypericum Extr.Hyperici sicc. drag. 255-285mg N60 Bionorica<br />

Krewel Meuselbach<br />

Krewel Meuselbach


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 223<br />

No. Commercial name General name<br />

2398. Helicocin Amoxicillinum;<br />

Metronidazolum<br />

Pharmaceutical<br />

form<br />

tab. oval; tab.<br />

round<br />

2399. Helmintox Pyrantelum tab. 125mg<br />

N6<br />

2400. Helmintox Pyrantelum tab. 250mg<br />

N3<br />

2401. Helmintox Pyrantelum oral susp. 5g/100ml<br />

15ml<br />

2402. Hemofer Ferrosi (II) chloridum (Ferrum<br />

Fe2+)<br />

2403. Hemofer prolongatum Ferri sulfas drag. 325mg<br />

N30<br />

2404. Hemofil M<br />

1 000 IU<br />

Human coagulation factor VIII powder and<br />

solvent for sol.<br />

for inj.<br />

2405. Hemofil M 250 IU Human coagulation factor VIII powder and<br />

solvent for sol.<br />

for inj.<br />

2406. Hemofil M 500 IU Human coagulation factor VIII powder and<br />

solvent for sol.<br />

for inj.<br />

2407. Hemorigen Herb. Erigeroni canadensis+<br />

Ethanolum<br />

2408. Hemorol Chamomillae extractum<br />

spissum+Genistae scop.<br />

extractum spissum+<br />

Hippocastani cort. extractum<br />

spissum+Belladonnae<br />

extractum spissum +<br />

Tormentillae extractum<br />

spissum+ Millefolii extractum<br />

spissum+Anaesthesinum<br />

2409. Hemorron Paraffinum liquidum+<br />

Vaselinum+ Shark liver oil+<br />

Phenylephrini hydrochloridum<br />

2410. Hemsyneral-TD Ferri fumaras+<br />

Cyanocobalaminum+Acidum<br />

folicum<br />

2411. Hepa-Merz L-ornithini-L-aspartas concentrate for<br />

inf.<br />

2412. Hepa-Merz Granulat<br />

3 000<br />

2413. Hepacon Lycopodium clavatum D5+<br />

Chelidonium majus D5+<br />

Berberis vulgaris D3+Iris<br />

versicolor D5+ Fumaria<br />

officinalis D5<br />

2414. Hepacon Lycopodium clavatum D5 +<br />

Chelidonium majus D5+<br />

Berberis vulgaris D3+Iris<br />

versicolor D5+ Fumaria<br />

officinalis D5<br />

Strength Manufacturer<br />

750mg; 500mg N21+21 Biochemie<br />

Innotech<br />

International<br />

Innotech<br />

International<br />

Innotech<br />

International<br />

oral sol. 157mg (44mg)/ml 10ml Medana Pharma<br />

Terpol<br />

1 000 IU/ vial+vial 10ml water<br />

for inj.+administration device<br />

N1<br />

250IU/vial+ vial 10ml wa-ter<br />

for inj. + administra-tion<br />

device N1<br />

500IU/vial+vial 10ml water for<br />

inj.+administration device N1<br />

Polfa Poznan<br />

Baxter<br />

Baxter<br />

Baxter<br />

extr. 0,5partis+ 1pars 30g; 100g Herbapol Kle˛ka<br />

supp. 50mg+20mg+20mg+<br />

20mg+20mg+20mg+<br />

100mg<br />

N12<br />

ointment 140mg+ 719mg+ 30mg+<br />

2,5mg/g 57g<br />

caps. 200mg+ 15µg+1,5mg N30 USV<br />

Herbapol Wroclaw<br />

Pharmas-cience<br />

5g/10ml amp. N10 Braun Arzneimittel<br />

L-ornithini-L-aspartas gran. 3g/5g sachets N30 Ursapharm<br />

tab. 100mg+<br />

100mg+ 100mg+<br />

100mg+<br />

100mg/g<br />

N30; N50; N60<br />

oral drops 100mg+<br />

100mg+ 100mg+<br />

100mg+ 100mg/g<br />

20ml; 50ml<br />

Aconitum<br />

Aconitum


EN<br />

224 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

2415. Hepadial Magnesium salt of dimecrotic<br />

acid<br />

Pharmaceutical<br />

form<br />

2416. HepaGel Heparinum natricum gel. 400 UI/g<br />

50g; 100g<br />

Strength Manufacturer<br />

coated tab. 50mg Lab. Biocodex<br />

Spirig Pharma<br />

2417. Heparin ‘Biochemie’ Heparinum natricum sol. for inj. 25000 IU/5ml Biochemie<br />

2418. Heparin Leo Heparinum natricum sol. for inj. 5000 UI/ml 5ml bute-liuke<br />

N50<br />

2419. Heparin Sodium Heparinum natricum subst. Schweizerhall<br />

Pharma<br />

2420. Heparin Sodium Panpharma Heparinum natricum sol. for inj. 25000IU/5ml N10 po 5 ml Panpharma<br />

2421. Heparinas Heparinum natricum subst. >=140 UA/mg 10-30g;<br />

0,5-2kg<br />

Leo<br />

Endokrininiai<br />

preparatai<br />

2422. Heparino tirpalas injekcijoms Heparinum natricum sol. for inj. 5000UA/ml N5 Endokrininiai<br />

preparatai<br />

2423. Heparin-ratiopharm 30 000<br />

tepalas<br />

Heparinum natricum ointment 30 000UI /100g Merckle<br />

2424. Heparin-ratiopharm Sport-Gel Heparinum natricum gel 60 000 UI/100g 50g;100g Merckle<br />

2425. Heparoid Lečiva Heparinoidum ointment 100U/mg 60mg/30g 30g Lečiva<br />

2426. Hepatect Hepatitis B immunoglobulin sol. for inf. and<br />

inj.<br />

50IU anti-HBs/ml amp. 2ml;<br />

10ml<br />

2427. Hepatil Ornithini aspartas tab. 150mg N40 Pliva Krakow<br />

2428. Hepatil Ornithini aspartas sol.for inj. 500mg/5ml amp. N10 Pliva Krakow<br />

2429. Hepatofalk Planta Sausas margalapio margainio<br />

(Silybum marianum) se˙klu˛<br />

ekstraktas+Sausas<br />

ugniazˇole˙s(Che-lidonii herba)<br />

ekstraktas+Sausas geltonosios<br />

ciberzˇole˙s(Curcuma xanth.<br />

rhiz.)ekstraktas, kuriame yra<br />

apie 54% natyvinio ekstrakto<br />

2430. Hepavitas Extractum Cardui mariae e<br />

fructibus siccum +Extractum<br />

Picrorhizae kurroa+Extractum<br />

Chelidonii e herba siccum +<br />

Extractum Cynarae e folus<br />

siccum +Cholinhydrogenotartras+Inositolum+<br />

L-Methioninum+<br />

L-Cysteinum+<br />

Cyanocobalaminum<br />

2431. Hepeel Lycopodium clavatum D3+<br />

Chelidonium majus D4+ China<br />

D3+Nux moschata D4 +<br />

Carduus marianus D2+<br />

PhosphorusD6+ Veratrum<br />

album D6+Citrullus<br />

colocynthis D6<br />

caps. 132,1-162,8mg+90-100mg+<br />

25mg N50,N100<br />

caps.,soft 100mg+ 100mg+ 50mg+<br />

50mg+ 50mg+ 20mg+ 20mg+<br />

15mg+ 1,5µg N40<br />

tab. 30mg+30mg+30mg+ 30mg+<br />

15mg+15mg+ 60mg+90mg<br />

N50; N250<br />

2432. Hepo AC Milk Thistle dry extr. caps. 125 mg<br />

N15; N30<br />

2433. Herceptin Trastuzumab powder for<br />

conc. for sol.<br />

for inf.<br />

Biotest<br />

Falk<br />

Arco-Chemie<br />

Heel<br />

150mg/vial N1 Roche<br />

Hasco-Lek/ Acorus<br />

calamus


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 225<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2434. Hernovir 5 % cream Aciclovirum cream 50mg/g 10g Nobel Ilac Sanayii<br />

2435. Herpacon Sepia officinalis D6+ Rhus<br />

toxicodendron D6 + Acidum<br />

silicicum D6 + Cantharis<br />

vesiculosa D10 + Natrium<br />

chloratum D10+ Ranunculus<br />

bulbosus D6+ Croton tiglium<br />

D6<br />

ointment 0.5mg+0,5mg+0,5mg+<br />

0,5mg+10mg+0,5mg+<br />

0,5mg/g<br />

30g; 50g<br />

Aconitum<br />

2436. Herpesin 200 Aciclovirum tab. 200mg N25 Lachema<br />

2437. Herpesin 250 Aciclovirum powder for sol.<br />

for inj.<br />

250mg<br />

N10<br />

Lachema<br />

2438. Herpesin 400 Aciclovirum tab. 400mg N25 Lachema<br />

2439. Herpofug Aciclovirum cream 50mg/g 2g; 5g Wolff<br />

2440. Herz ASS-ratiopharm 100 Acidum acetylsalicylicum tab. 100mg<br />

N50; N100<br />

2441. Hevertolax Phyto Extr.sicc.fruct. Sennae liq. (6-12:1) 1,7-2,56g/100ml<br />

30ml;100ml;250ml<br />

2442. Heviran Aciclovirum film coated<br />

tablets<br />

2443. Heviran Aciclovirum film coated<br />

tablets<br />

2444. Heviran Aciclovirum film coated<br />

tablets<br />

2445. Hexadreps Biclotymolum lozenge 20mg<br />

N12<br />

2446. Hexadreps Orange Biclotymolum lozenge 20mg<br />

N12<br />

2447. Hexalyse Biclotymolum+ Lysozymi<br />

hydrochloridum+ Enoxolonum<br />

Merckle<br />

Hevert<br />

200mg N30 Pharmaceutical<br />

Works ‘Polpharma’<br />

S.A.<br />

400mg N30 Pharmaceutical<br />

Works ‘Polpharma’<br />

S.A.<br />

800mg N30 Pharmaceutical<br />

Works ‘Polpharma’<br />

S.A.<br />

Dietetique et<br />

Pharmaceutique<br />

Dieteti-que et<br />

Pharma-ceutique<br />

suckab- le tab. 5mg+5mg+5mg N30 Doms Adrian<br />

2448. Hexamandin Methenamine mandelate tab. 250 mg N50 Liuks<br />

2449. Hexapneumine Biclotymolum+ Phenylephrini<br />

hydrochloridum+<br />

Chlorphenamini maleas<br />

2450. Hexapneumine Adults Pholcodinum+<br />

Chlorphenamini maleas+<br />

Biclotymolum<br />

2451. Hexapneumine Children Pholcodinum+<br />

Chlorphenamini maleas+<br />

Biclotymolum<br />

2452. Hexapneu-mine Infants Biclotymolum+<br />

Chlorphenamini maleas<br />

tab. 30mg+ 10mg+2mg N20 Doms Adrian<br />

syrup 120mg+ 12mg+ 200mg/<br />

100ml 200ml<br />

syrup 100mg+ 10mg+ 150mg/<br />

100ml 200ml<br />

Doms Adrian<br />

Doms Adrian<br />

syrup 100mg+ 5mg/100ml 100ml Doms Adrian


EN<br />

226 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2453. Hexaspray Biclotymolum throat spray 750mg/30g 30g Doms Adrian<br />

2454. Hexavac Purified diphtheria toxoid+<br />

Purified tetanus toxoid+<br />

Purified pertussis toxoid+<br />

Purified pertussis filamentous<br />

haemaggluti- nin+Hepatitis B<br />

surface antigen+Inactivated<br />

type 1 poliovirus (Mahoney) D<br />

antigen+Inactivated type 2<br />

poliovirus (MEF1) D antigen<br />

susp. for inj. >=20 IU+>=40IU+ 25µg+<br />

25µg+5µg+40 units+8 units+<br />

32 units+12µg/<br />

dose 0,5ml pre-filled syringe<br />

N1<br />

Aventis Pasteur<br />

2455. Hexoral Hexetidinum sol. 100mg/ 100ml 200ml Gödecke<br />

2456. Hexoral purškalas Hexetidinum spray 200mg/ 100ml 40ml Godecke<br />

2457. Hexoraletten N Chlorhexidinum+<br />

Benzocainum<br />

2458. Hiberix Haemophilus influenzae type B<br />

vaccine+ Tetanus toxoid<br />

lozenges 5mg+1,5mg N20 Gödecke<br />

powder for sol.<br />

for inj.<br />

2459. Hiconcil Amoxicillinum powder for oral<br />

drops<br />

2460. Hiconcil Amoxicillinum powder for oral<br />

susp.<br />

10µg+30µg/ 0,5ml<br />

N5; N25<br />

100mg/ml 10ml KRKA<br />

250mg/5ml 100ml KRKA<br />

2461. Hiconcil Amoxicillinum caps. 250mg N16 KRKA<br />

2462. Hiconcil Amoxicillinum powder for oral<br />

susp.<br />

125mg/5ml 60ml KRKA<br />

2463. Hiconcil Amoxicillinum caps. 500mg N16 KRKA<br />

2464. Hidrochlortiazido tablete˙s Hydrochlorothiazidum tab. 0,025 g N20 Liuks<br />

2465. Hioxyl Cream Hydrogenii peroxidum cream 1,5%<br />

25g<br />

2466. Hioxysonum ung. Hydrocortisonum/<br />

Oxytetracyclinum<br />

2467. Hipuran-131 I Sodium oiodohippurate<br />

(diagnostic)<br />

ointment 10g; 15g; 20g; 30g Liuks<br />

SmithKline Beecham<br />

Quinoderm<br />

sol. for inj. 2-20 mg/ml (3,7-74 MBq/ml) Polatom<br />

2468. Hirudoid Mucopolysaccharidi polysulfas cream 300mg/100g 40g; 100g Sankyo Pharma<br />

2469. Hirudoid Mucopolysaccharidi polysulfas gel 300mg/100g 40g; 100g Sankyo Pharma<br />

2470. Hismanalis Astemizolum tab. 10 mg N30; N50; N60 Liuks<br />

2471. Histac Ranitidinum film-coated tab. 150mg<br />

N20; N100<br />

Ranbaxy<br />

2472. Histac EVT Ranitidinum efferv. tab. 150mg N10 Ranbaxy<br />

2473. Histac Tablets<br />

75 mg<br />

2474. Histalgan Nonivamidum+ Benzylis<br />

nicotinas +Hydroxyethylis<br />

salicylas+Dimethylis<br />

sulfoxidum<br />

2475. Histalgan mite Hydroxyethylis salicylas+<br />

Dimethylis sulfoxidum<br />

Ranitidinum tab. 75mg N6 Ranbaxy<br />

lin. 0,75mg+2,5mg+100mg+<br />

200mg/g<br />

50g<br />

lin. 100mg+ 300mg/g<br />

50g<br />

Spirig Pharma<br />

Spirig Pharma


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union <strong>227</strong><br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2476. Histodil Cimetidinum sol. for inj. 200mg/2ml 2ml amp. N10 Gedeon Richter<br />

2477. Histodil Cimetidinum tab. 200mg<br />

N50<br />

2478. Hivid Zalcitabinum film-coated tab. 0,75mg N100 Roche<br />

2479. Hjertemagnyl Acidum acetylsalicylicum+<br />

Magnesii oxidum<br />

2480. HL-Cold Acidum acetylsalicylicum+<br />

Phenylpropanolaminum+<br />

Chlorphenaminum<br />

Gedeon Richter<br />

tab. 150mg+ 21mg N30; N90 Nycomed DAK/<br />

Nycomed SEFA<br />

efferv. tab. 325mg+ 15mg+ 2mg N20 Perrigo<br />

2481. Holetar Lovastatinum tab. 20mg N20 KRKA<br />

2482. Holetar Lovastatinum tab. 40mg N30 KRKA<br />

2483. Holoxan Ifosfamidum powder for inj.<br />

i.v.<br />

2484. Holoxan Ifosfamidum powder for inj.<br />

i.v.<br />

2485. Holoxan 1g Ifosfamidum powder for<br />

solution for<br />

injection<br />

2486. Holoxan 500mg Ifosfamidum powder for<br />

solution for<br />

injection<br />

2487. Homeovox Aconitum napellus 3 CH+<br />

Arum triphyllum 3 CH+<br />

Ferrum phosphoricum 6 CH +<br />

Calendula officinalis 6CH +<br />

Spongia tosta 6 CH+<br />

Belladonna 6 CH+ Mercurius<br />

solubilis 6 CH+ Hepar sulphur<br />

6 CH+ Kalium bichromicum<br />

6 CH + Populus candicans<br />

6 CH +Bryonia dioica 3 CH<br />

200mg<br />

N10<br />

2g<br />

N1;N10<br />

1g/vial<br />

N1<br />

500mg/vial<br />

N1<br />

coated tab. 0,091mg+ 0,091mg+<br />

0,091mg+ 0,091mg+<br />

0,091mg+ 0,091mg+<br />

0,091mg+ 0,091mg+<br />

0,091mg+ 0,091mg+<br />

0,091mg N60<br />

Asta Medica<br />

Asta Medica<br />

Asta Medica<br />

Asta Medica<br />

2488. Honvan Fosfestrolum sol. for inj. 300mg/5ml amp. N10 Asta Medica<br />

2489. Honvan Fosfestrolum film-coated tab. 120mg N50;100 Asta Medica<br />

2490. Hormeel S compos. drops 30ml; 100ml Heel<br />

2491. Hotemin Piroxicamum caps. 10mg N20 Egis<br />

2492. Hotemin Piroxicamum caps. 20mg N20 Egis<br />

2493. Hotemin Piroxicamum supp. 10mg N10 Egis<br />

2494. Hotemin Piroxicamum supp. 20mg N10 Egis<br />

2495. Hotemin Piroxicamum sol. for inj. 20mg/ml<br />

1ml amp. N5<br />

2496. Hotemin Piroxicamum cream 500mg/50g 50g Egis<br />

2497. Humaglobin Immunoglobulin powder for sol.<br />

for inf.<br />

Boiron<br />

Egis<br />

50mg/ml 50ml;100ml Human<br />

2498. Humalog Insulinum lisprum sol. for inj. 100U/ml 10ml vials N1 Lilly France<br />

2499. Humalog Insulinum lisprum sol. for inj. 100U/ml 3ml cartridges N5 Lilly France


EN<br />

228 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2500. Humalog Insulinum lisprum sol. for inj. 100 IU/ml 1,5ml cartridges N5 Lilly France<br />

2501. Humalog Mix 25 Insulinum lisprum susp. for inj. 100U/ml 3ml cartridges N5 Lilly France<br />

2502. Humalog Mix 25 Pen Insulinum lisprum susp. for inj. 100U/ml 3ml cartridges N5 Lilly France<br />

2503. Humalog Mix 50 Insulinum lisprum susp. for inj. 100U/ml 3ml cartridges N5 Lilly France<br />

2504. Humalog-Pen Insulinum lisprum sol. for inj. 100U/ml pre-filled/disposable<br />

pen injector 3ml cartridges N5<br />

Lilly France<br />

2505. Human Albumin 20% solution Albuminum humanum sol. for inf. 200g/1000ml 50ml; 100ml Human<br />

2506. Human Gamma-globulin 16%<br />

Solution<br />

Human gamma-globulin (IgG,<br />

IgA, IgM)<br />

2507. Humatrope Somatropinum powder and<br />

solvent for sol.<br />

for inj.<br />

2508. Humatrope Somatropinum powder and<br />

solvent for sol.<br />

for inj.<br />

sol. for inj. 160mg/ml 2ml Human<br />

18IU/3ml cartridge Eli Lilly<br />

36IU/3ml cartridge Eli Lilly<br />

2509. Humulin 70/30 Insulinum humanum susp. for inj. 100U/ml 1,5ml cartridge N5 Lilly France<br />

2510. Humulin 70/30 Pen Human Insulin (70% isophane,<br />

30% neutral) rDNA origin<br />

susp. for inj. in<br />

pre-filled<br />

disposable pen<br />

100IU/ml<br />

3ml cartrige N5<br />

2511. Humulin Lente Insulinum humanum susp. for inj. 100IU/ml<br />

10ml vial<br />

2512. Humulin M3 (30/70) Insulinum humanum (Insulini<br />

injectio biphasica)<br />

susp. for inj. 100 IU/ml 3ml cartridges<br />

N5<br />

Lilly France<br />

Lilly<br />

Lilly France<br />

2513. Humulin N Human Insulin rDNA origin susp. for inj. 100IU/ml 1,5ml cartridge N5 Lilly France<br />

2514. Humulin N Insulinum humanum<br />

(Isophanum insulinum)<br />

2515. Humulin N Pen Human Insulin isophane rDNA<br />

origin<br />

2516. Humulin NPH Isophanum insulinum<br />

humanum<br />

susp. for inj. 100 IU/ml 3ml cartridge N5 Lilly France<br />

susp. for inj. in<br />

pre-filled<br />

disposable pen<br />

susp. for inj. 100IU/ml<br />

10ml vial<br />

100IU/ml 3ml cartridge N5 Lilly France<br />

2517. Humulin R Human Insulin rDNA origin sol. for inj. 100IU/ml 1,5ml cartridge N5 Lilly France<br />

2518. Humulin R Insulinum humanum (Insulini<br />

injectio neutralis)<br />

2519. Humulin R Pen Human Insulin neutral rDNA<br />

origin<br />

Lilly<br />

sol. for inj. 100 IU/ml 3ml cartridge N5 Lilly France<br />

sol. for inj. 100IU/ml pre-filled disposable<br />

pen 3ml cartridge N5<br />

2520. Humulin Regular Insulinum humanum sol. for inj. 100IU/ml<br />

10ml vial<br />

2521. Hustagil balzamas nuo<br />

peršalimo<br />

2522. Hustagil čiobreliu˛ sirupas nuo<br />

kosulio<br />

Thymi aetheroleum+ Pini<br />

aetheroleum+ Eucalypti<br />

aetheroleum+ Caryophylli<br />

floris aetheroleum<br />

Thymi extractum fluidum (1:2-<br />

2,5)<br />

ointment 20mg+ 20mg+ 20mg+<br />

10mg/g 45g<br />

oral sol. 480mg/5ml (Ethanolum<br />

3,5 vol.-%) 150ml<br />

Lilly France<br />

Lilly<br />

Dentinox<br />

Dentinox


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 229<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2523. Hustagil Thyme Cough Extr. Thymi fluidum oral drops 900mg/30ml Dentinox<br />

2524. Husteel Arsenium jodatum D6+<br />

Atropa belladonna D4+ Scilla<br />

D4+ Cuprum aceticum D6+<br />

Causticum Hahnemanni D6<br />

Alcohol 35Vol.-%<br />

2525. Hycamtin Topotecanum powder for sol.<br />

for inf.<br />

drops 20g+20g+ 20g+10g+<br />

30g/100g 30ml; 100ml<br />

1mg/ml; 1mg/vial; 4mg/vial<br />

single dose N1; N5<br />

2526. Hydiphen Clomipraminum sol. for inj. 25mg/2ml N10 AWD<br />

2527. Hydiphen 25 Clomipraminum drag. 25mg N50 AWD<br />

Heel<br />

SmithKline Beecham<br />

2528. Hydrea Hydroxycarbamidum caps. 500mg N100 Bristol-Myers Squibb<br />

2529. Hydrocortison Hydrocortisonum eye ointment 5mg/g 3g Jelfa<br />

2530. Hydrocortison DAK 1% Hydrocortisonum ointment 10mg/g 30g Nycomed Pharma<br />

2531. Hydrocortison solubile inj. ICN Hydrocortisonum powder for sol.<br />

for inj.<br />

100mg/vial N1 ICN Czech Republic<br />

2532. Hydrocortison-Richter Hydrocortisonum+ Lidocainum susp. for inj. 125mg+25mg/5ml vials N1 Gedeon Richter<br />

2533. Hydrocortisonum Hydrocortisonum cream 10mg/g 15g;20g Homeofarm<br />

2534. Hydrogenii peroxidum 3% Hydrogenii peroxidum liquid 3% 100g Hasco-Lek<br />

2535. Hydromol Emollient Vaselinum album+Isopropylis<br />

myristas<br />

topical solution 37,8%+13% 150ml; 350ml; 1l Quinoderm<br />

2536. Hydroperitum Hydroperitum tab. 1,5g N8; N10; N20; N50 Liuks<br />

2537. Hydroxycarbamide Hydroxycarbamidum caps. 500mg<br />

N100<br />

Pliva Krakow<br />

2538. Hydroxyzinum Hydroxyzinum coated tab. 25mg N30 ICN Polfa Rzeszow<br />

2539. Hydroxyzinum Hydroxyzinum coated tab. 10mg N30 ICN Polfa Rzeszow<br />

2540. Hypaque meglumine 60 % Diatrizoic acid+Meglumine sol. for inj. 455,3mg+<br />

144,7mg/ml 20ml; 50ml<br />

2541. Hypaque meglumine 76 % Diatrizoic acid+Meglumine sol. for inj. 597,4mg+<br />

159,2mg/ml 20ml; 50ml<br />

2542. Hyper HAES Poly(0-2-hydroxyethyl) starch+<br />

Sodium chloride<br />

solution for<br />

infusion<br />

Nycomed Puerto<br />

Rico<br />

Nycomed Puerto<br />

Rico<br />

60g+72g/l 250ml Fresenius Kabi<br />

Deutschland GmbH<br />

2543. Hypericaps Extr. Hypericum perforatum caps. 200 mg Sanitas<br />

2544. Hyperico AC St. John's Wort dry extr. caps. 150 mg<br />

N15; N30<br />

2545. Hyperico AC forte St. John's Wort dry extr. caps. 300 mg<br />

N20; N40<br />

2546. Hypnogen Zolpidemi tartras film-coated tab. 10mg N15;N20 Lečiva<br />

2547. Hypolis (Jonazˇole˙s aliejus) Herba Hyperici+ Oleum<br />

Helianthi (Hipericin)<br />

sol. 1pars+4 partis (>2mg/100ml)<br />

50ml; 100ml<br />

2548. Hypothiazid Hydrochlorothiazidum tab. 25mg<br />

N20<br />

Hasco-Lek/ Acorus<br />

calamus<br />

Hasco-Lek/ Acorus<br />

calamus<br />

Endokrininiai<br />

preparatai<br />

Chinoin


EN<br />

230 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2549. Hypothiazid Hydrochlorothiazidum tab. 100mg<br />

N20<br />

2550. Hypromeloza-P Unimed<br />

Pharma<br />

Hydroxypropylmethylcellulosum<br />

(Hypromellosum)<br />

eye drops 5mg/ml<br />

10ml<br />

Strength Manufacturer<br />

2551. Hytrin Terazosinum tab. white tab.:1mg N7;yellow tab.:<br />

2mg N7<br />

Chinoin<br />

Unimed Pharma<br />

Abbott<br />

2552. Hytrin Terazosinum tab. 5mg N14; N28 Abbott<br />

2553. Hytrin Terazosinum tab. 10mg<br />

N14; N28<br />

Abbott<br />

2554. Hytrin Terazosinum tab. 2mg N14; N28 Abbott<br />

2555. Hyzaar Losartanum+<br />

Hydrochlorothiazidum<br />

2556. Iberogast Alcoholic extracts of: Iberis<br />

amara (6:10)+Angelica root<br />

(3,5:10)+Mat-ricaria flower<br />

(3,5:10)+ Caraway fruit<br />

(3,5:10)+ St.Mary's thistle fruit<br />

(3,5:10)+ Balm leaf (3,5:10)+<br />

Peppermint leaf (3,5:10)+<br />

Celandine herb (3,5:10)+<br />

Liquorice root (3,5:10)<br />

(Ethanol 31%)<br />

film-coated tab. 50mg+12,5mg N28 MSD<br />

sol. 15ml+10ml+<br />

20ml+10ml+<br />

10ml+10ml+<br />

5ml+10ml+<br />

10ml/100ml 20ml; 50ml;<br />

100ml<br />

2557. Ibucod Ibuprofenum+ Codeinum tab. 200mg+10mg N10; N100 Delta<br />

2558. Ibucod forte Ibuprofenum+ Codeinum tab. 200mg+30mg N30; N100 Delta<br />

2559. Ibufen Ibuprofenum oral susp. 100mg/5ml 100g Terpol<br />

Steigerwald<br />

2560. Ibumax Ibuprofenum tab. 400mg N10; N30, N100 Vitabalans<br />

2561. Ibumax Ibuprofenum tab. 400mg N10; N30, N100 Vitabalans<br />

2562. Ibumetin 200 Ibuprofenum film-coated tab. 200mg N10 Nycomed Danmark/<br />

Nycomed SEFA<br />

2563. Ibumetin 400 Ibuprofenum tab. 400mg N10 Nycomed Danmark/<br />

Nycomed SEFA<br />

2564. Ibumetin 5 % gelis Ibuprofenum gel. 50mg/g<br />

50g<br />

Fleet Laboratories<br />

2565. Ibuprofen Ibuprofenum coated tab. 200mg N100 Polfa Pabianice<br />

2566. Ibuprofen Alpharma Tablets<br />

400 mg<br />

Ibuprofenum film-coated tab. 400mg N10; N20; N50 Alpharma<br />

2567. Ibuprofen Lannacher Ibuprofenum film-coated tab. 600mg<br />

N30;N50<br />

2568. Ibuprofen Lannacher Ibuprofenum film-coated tab. 400mg<br />

N30;N50<br />

Lannacher<br />

Lannacher<br />

2569. Ibuprofenas 400 mg Ibuprofenum film-coated tab. 400mg N30;N100 Pharmamed/ Ilsanta<br />

2570. Ibuprofenas 200 mg Ibuprofenum film-coated tab. 200mg N30;N100 Pharmamed/ Ilsanta<br />

2571. Ibuprofeno tablete˙s Ibuprofenum tab. 0,2 N50 Liuks<br />

2572. Ibutop Gel Ibuprofenum gel 5g/100g 50g Dolorgiet


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 231<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2573. Ichtiolo 10 % tepalas Ichthyolum ointment 10g/100g 25g; 200g Sanitas<br />

2574. Ideal weight (Idealus svoris) Extr.Sennae sicc. +<br />

Extr.fol.Betulae sicc.+<br />

Extr.Phaseoli vulgaris sicc.+<br />

Extr.rad.Ononidis sicc.<br />

2575. Ideos Calcii carbonas+<br />

Colecalciferolum<br />

2576. Ido-Form Enterococcus faecium+<br />

Bifidobacterium longum<br />

2577. Ignatia-Homaccord Ignatia D4+<br />

Ignatia D10+ Ignatia D30+<br />

Ignatia D200+ Moschus<br />

moschiferus D6+ Moschus<br />

moschiferus D30+ Moschus<br />

moschiferus D200; Spiritus<br />

aethylicus 35%<br />

2578. Ilon Abszess-Salbe Terebinthina ex Laricis sibirica.<br />

Ol. Terebinthinae purificata<br />

caps. 75mg+ 30mg+ 20mg+ 20mg<br />

N40<br />

chewable tab. 1250mg+<br />

400IU<br />

gastro-resistant<br />

caps.<br />

17,2mg+ 10,8mg<br />

N30<br />

drops 0,5g+0,5g+<br />

0,5g+0,5g+<br />

0,5g+ 0,5g+ 0,5g/100g<br />

oint-ment 54mg+ 72mg/g 10g;18g; 25g;<br />

50g; 100g<br />

2579. Ilosone liquid Erythromycinum oral susp. 125mg/5ml 100ml Lilly<br />

2580. Ilosone liquid Erythromycinum oral susp. 250mg/5ml 100ml Lilly<br />

2581. Imacort Clotrimazolum+<br />

Hexamidinum+ Prednisolonum<br />

cream 10mg+2,5mg+ 5mg/g<br />

20g<br />

2582. Imazol Clotrimazolum cream-paste 10mg/g<br />

30g<br />

Arco-Chemie<br />

Lab. Innothera<br />

Ferrosan/<br />

Chr.Hansen<br />

BioSystems/ Pharma<br />

Vinci<br />

Heel<br />

Redel<br />

Spirig Pharma<br />

Spirig Pharma<br />

2583. Imazol Clotrimazolum+ Hexamidinum cream 10mg+2,5mg/g 30g Spirig Pharma<br />

2584. Imbieru˛ tinktūra Zingiberi rhizoma tinct. 200 g Ethanolum ad 1 l 50 ml,<br />

100 ml<br />

2585. Imdur Durules Isosorbidi mononitras controlledrelease<br />

tab.<br />

60mg<br />

N30; N100<br />

Bakteriniai<br />

preparatai<br />

2586. Imex Tetracyclinum ointment 30mg/g 5g; 20g Merz+Co<br />

2587. Imidin N Nosedrops Xylometazolinum nasal drops, sol. 1mg/ml<br />

10ml<br />

2588. Imidin N Nosespray Xylometazolinum sol.for spraying<br />

into the nose<br />

1mg/ml<br />

10ml<br />

2589. Imigran Sumatriptanum tab. 50mg<br />

N2<br />

2590. Imigran Sumatriptanum sol. for inj. 6mg/0,5ml<br />

N2 pre-filled syringe plus an<br />

autoinjector<br />

2591. Imigran Sumatriptanum tab. 100mg<br />

N2; N6; N10<br />

2592. Imigran Nasal Spray Sumatriptanum nasal spray, sol. 20mg/0,1ml unit dose<br />

disposable nasal spray device<br />

N2<br />

Astra<br />

Wernigerode<br />

Wernigerode<br />

Glaxo Wellcome<br />

Glaxo<br />

Glaxo<br />

Glaxo Wellcome


EN<br />

232 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2593. ImmuCyst Bacillus Calmette-Guerin lyophilisate+<br />

diluent for<br />

reconstitution<br />

for inj.<br />

2594. Immunal drops Echinaceae purpureae herba<br />

succus<br />

2595. Immunate 1 000 IU Human blood coagulation<br />

factor VIII<br />

2596. Immunate 250 IU Human blood coagulation<br />

factor VIII<br />

2597. Immunate 500 IU Human blood coagulation<br />

factor VIII<br />

2598. Immunine 1200 Human blood coagulation<br />

factor IX<br />

2599. Immunine 200 Human blood coagulation<br />

factor IX<br />

2600. Immunine 600 Human blood coagulation<br />

factor IX<br />

Strength Manufacturer<br />

27mg BCG and diluent 1ml<br />

N3+3 vials<br />

oral drops, sol. 0,8ml/ml 50ml Lek<br />

powder for sol.<br />

for inj./inf.<br />

powder for sol.<br />

for inj./inf.<br />

powder for sol.<br />

for inj./inf.<br />

powder for sol.<br />

for i.v.inj.<br />

powder for sol.<br />

for i.v.inj.<br />

powder for sol.<br />

for i.v.inj.<br />

1000IU N1 Baxter<br />

250IU N1 Baxter<br />

500IU N1 Baxter<br />

1200IU Baxter<br />

200IU Baxter<br />

600IU Baxter<br />

Aventis Pasteur<br />

2601. Immunogiobulin i.v. 1 g Immunoglobulin G powder for inj. 1g Biochemie<br />

2602. Immunoglobulinum humanum<br />

contra encephalitidem<br />

ixodicum<br />

Immunoglobulinum humanum<br />

contra encephalitidem<br />

ixodicum<br />

sol. for inj. >1:80 1ml amp. N10 Pastero VI˛<br />

2603. Imodium Loperamidum caps. 2mg N6; N20; N60 Janssen-Cilag<br />

2604. Imodium lingual Loperamidum lingual tab. 2mg<br />

N10; N20<br />

Scherer DDS/<br />

Janssen-Cilag<br />

2605. Imodium Plus Loperamidum+ Simeticonum chewable tab. 2mg+125mg N6 McNeil/ Janssen-<br />

Cilag<br />

2606. Imogam Rabies Human rabies immunoglobulin sol. for inj. 300IU/2ml<br />

N1 2ml; 10ml<br />

2607. Imovane Zopiclonum film-coated tab. 7,5mg<br />

N5;N20<br />

2608. Imovax dT adult Purified diphtheria toxoid,<br />

inactivated, adsorbed+ Purified<br />

tetanus toxoid, inactivated,<br />

adsorbed<br />

2609. Imovax dT adult (single dose) Purified diphtheria toxoid,<br />

inactivated, adsorbed+ Purified<br />

tetanus toxoid, inactivated,<br />

adsorbed<br />

2610. Imovax Polio (single dose) Poliomyelitis vaccine:<br />

inactivated Polio virus type 1+<br />

inactivated Polio virus type 2+<br />

inactivated Polio virus type 3<br />

2611. Implanon Etonogestrelum implant for<br />

subdermal use<br />

2612. Importal Lactitolum monohydricum powder for oral<br />

sol.<br />

2613. Importal Oral Solution<br />

multidose<br />

susp. for inj. >2IU+>20IU/0,5ml 5ml vial<br />

(10 doses) N10<br />

susp. for inj. >2IU+>20IU/0,5ml pre-filled<br />

syringe N1<br />

susp. for inj. 40D Antigen units+ 8 Antigen<br />

units+ 32 Antigen units /0,5ml<br />

amp. N1;N20<br />

Pasteur Merieux<br />

Rhone-Poulenc<br />

Rorer<br />

Pasteur Merieux<br />

Pasteur Merieux<br />

Pasteur Merieux<br />

68mg N1 Organon<br />

10g/sachet N10; N20; N50 Novartis Consumer<br />

Lactitolum monohydricum oral sol. 667mg/ml 200ml Novartis Consumer


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 233<br />

No. Commercial name General name<br />

2614. Imunital Echinaceae purpurea herba<br />

extractum fluidum (1:1)<br />

Pharmaceutical<br />

form<br />

2615. Imuran Azathioprinum coated tab. 50mg<br />

N100<br />

2616. Imuran Azathioprinum powder for sol.<br />

for inj.<br />

Strength Manufacturer<br />

liq. 25ml;50ml Bakteriniai<br />

preparatai<br />

Wellcome<br />

50mg/vial N1 Wellcome<br />

2617. Imuran Azathioprinum tab. 25mg N100 Wellcome<br />

2618. Indap Indapamidum caps. 2,5mg<br />

N30<br />

2619. Indatens Indapamidum caps. 2,5mg N30 Mepha<br />

2620. Indivina Estradioli valeras+<br />

Medroxyprogesteroni acetas<br />

2621. Indivina Estradioli valeras+<br />

Medroxyprogesteroni acetas<br />

2622. Indivina Estradioli valeras+<br />

Medroxyprogesteroni acetas<br />

Pro. Med. CS Praha<br />

tab. 2mg+5mg N28 Orion Pharma<br />

tab. 1mg+2,5mg N28 Orion Pharma<br />

tab. 1mg+5mg N28 Orion Pharma<br />

2623. Indomelan Indometacinum supp. 50mg N6 Lannacher<br />

2624. Indomelan Indometacinum supp. 100mg N6 Lannacher<br />

2625. Indomelan Indometacinum retard caps. 75mg N30; N50 Lannacher<br />

2626. Indomelan Indometacinum caps. 25mg N30; N50 Lannacher<br />

2627. Indomelan Indometacinum caps. 50mg N30; N50 Lannacher<br />

2628. Indomelan Indometacinum gel 1g/100g 25g; 40g Lannacher<br />

2629. Indometacin Indometacinum film-coated tab. 25mg<br />

N30<br />

2630. Indometacin Indometacinum ointment 100mg/g<br />

40g<br />

2631. Indometacin 100 Berlin-<br />

Chemie<br />

2632. Indometacin Balkanpharma<br />

10 % Gel<br />

Balkanpharma-<br />

Dupnitza<br />

Balkanpharma-<br />

Troyan<br />

Indometacinum supp. 100mg N10; N30; N50 Berlin-Chemie<br />

Indometacinum gel 100mg/g (Ethanolum<br />

96 % 188mg/g)<br />

40g<br />

2633. Indometacino 25 mg tablete˙s Indomethacin tab. 25 mg N30 Liuks<br />

Balkanpharma-<br />

Troyan<br />

2634. Indomethacin Indometacinum ointment 100mg/g 40g antibiotic<br />

2635. Indomet-ratiopharm 100<br />

Zapfchen<br />

Indometacinum supp. 100mg<br />

N10<br />

Merckle<br />

2636. Indomet-ratiopharm Gel Indometacinum gel 1g/100g 50g Merckle<br />

2637. Indopres Indapamidum tab. 25mg N30 Liuks<br />

2638. Indotard 75 Indometacinum sustainedrelease<br />

caps.<br />

2639. Indovasin Indometacinum+<br />

Troxerutinum<br />

75mg N10 CTS<br />

gel 30mg+ 20mg/g 45g Balkanpharma-<br />

Troyan


EN<br />

234 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2640. Indovis EC Indometacinum tab. 25mg N10; 30;50;100 CTS<br />

2641. Infanrix Diphtheria toxoid+Tetanus<br />

toxoid+Pertussis toxoid+<br />

Filamentous haemagglutinin +<br />

Pertactin<br />

2642. Infanrix HepB Diphtheria toxoid+Tetanus<br />

toxoid+Pertussis toxoid+<br />

Filamentous haemagglutinin+<br />

Pertactin+<br />

r-HBsAg<br />

2643. Infanrix Hexa compos. powder and<br />

solvent for<br />

suspension for<br />

injection<br />

2644. Infanrix Hib (combined<br />

diphtheria, tetanus, acellular<br />

pertussis and Haemophilus<br />

influenzae type b vaccine)<br />

Diphtheria toxoid+<br />

Tetanus toxoid+<br />

Pertussis toxoid+<br />

Filamentous haemagglutinin+<br />

Pertactin+Purified capsular<br />

polysaccharide of Hib<br />

covalently bound to tetanus<br />

toxoid<br />

2645. Infanrix Penta compos. suspension for<br />

injection<br />

2646. Infanrix-IPV+Hib Diphtheria toxoid+ Tetanus<br />

toxoid+ Pertussis toxoid+<br />

Filamentous haemagglutinin+<br />

Pertactin+ Inactivated polio<br />

virus type I+ Inactivated polio<br />

virus type II+ Inactivated polio<br />

virus type III+ Purified capsular<br />

polysaccharide of Hib<br />

covalently bound to tetanus<br />

susp. for inj. >=30IU+ >=40IU+ 25µg+<br />

25µg+8µg/0,5ml pre-filled<br />

sy-ringe, mono-dose N1<br />

susp. for inj. >=30IU+ >=40IU+ 25µg+<br />

25µg+ 8µg+ 10µg/dose (0,5ml)<br />

in pre-filled syringe without<br />

needle with inj. needle N1<br />

SmithKline Beecham<br />

SmithKline Beecham<br />

vial and 0,5ml PFS N1 GlaxoSmithKline<br />

Biologicals s.a.<br />

susp. for inj. >=30IU+ >=40IU+25µg+<br />

25µg+8µg+10µg/dose 0,5ml<br />

pre-filled syringe<br />

+HIB (lyophylised powder) vial<br />

N1<br />

GlaxoSmith<br />

Kline<br />

0,5ml PFS N1 GlaxoSmithKline<br />

Biologicals s.a.<br />

inj. i.m. >=30IU+ >=40IU+ 25µg+<br />

25µg+ 8µg+ 40DU+ 8DU+<br />

32DU+ 10µg/dose (0,5ml)<br />

SmithKline Beecham<br />

2647. Infesol 40 L-amino acids mixture sol. for inf. N10 500ml Berlin-Chemie<br />

(Menarini Group)<br />

2648. Inflagen<br />

1 000 000 TV<br />

2649. Inflagen<br />

3 000 000 TV<br />

2650. Inflagen<br />

1 000 000 TV<br />

2651. Inflagen<br />

3 000 000 TV<br />

Interferonum gamma<br />

humanum recombinatum<br />

Interferonum gamma<br />

humanum recombinatum<br />

Interferonum gamma<br />

humanum recombinatum<br />

Interferonum gamma<br />

humanum recombinatum<br />

for inj. dried 1 000 000 UI/<br />

vial<br />

N5<br />

for inj. dried 3 000 000 UI/ vial<br />

N5<br />

Biotechna<br />

Biotechna<br />

for inj. dried 1 000 000 UI /amp. N5 Biotechna<br />

for inj. dried 3 000 000 UI /amp. N5 Biotechna<br />

2652. Inflamac 50 Diclofenacum natricum caps. 50mg N20;N100 Spirig<br />

2653. Inflamac 75 SR Diclofenacum natricum caps. 75mg N20;N60 Spirig<br />

2654. Inflammide Budesonidum metered dose<br />

inhaler<br />

2655. Inflammide Budesonidum metered dose<br />

inhaler<br />

100µg/dose 300 doses Boehringer<br />

Ingelheim<br />

200µg/dose 300 doses Boehringer<br />

Ingelheim


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 235<br />

No. Commercial name General name<br />

2656. Influcid Aconitum D3+<br />

Gelsemium D3+<br />

Ipecacuanha D3+<br />

Phosphorus D5+<br />

Bryonia D2+<br />

Eupatorium perfoliatum D1<br />

2657. Influcid Aconitum D3+<br />

Gelsemium D3+<br />

Ipecacuanha D3+<br />

Phosphorus D5+<br />

Bryonia D2+<br />

Eupatorium perfoliatum D1<br />

2658. Influvac 2002/2003 A/Moscow/10/99 (H3N2)-like<br />

strain (A/Panama/2007/99<br />

RESVIR-17 reass.)+A/New<br />

Caledonia/20/99 (H1N1)-like<br />

strain (A/New Caledonia/<br />

20/99 IVR-116 reass.)+B/Hong<br />

Kong/330/2001-like<br />

(B/Shangdong/7/97)<br />

Pharmaceutical<br />

form<br />

tab. 25mg+25mg+<br />

25mg+25mg+<br />

25mg+25mg N60<br />

drops 10g+10g+10g+10g+10g+<br />

10g/100g 30ml<br />

Strength Manufacturer<br />

susp. for inj. 15µg haemagglutinin+ 15µg<br />

haemagglutinin + 15µg<br />

haemag glutinin / dose 0,5ml<br />

pre-filled syringe, single dose<br />

N1; N10<br />

2659. Infusamin 10 % infusion Amino acids mixture sol. for inf. 10% 500ml Human<br />

2660. Infusamin S5 infusion Amino acids mixture+Sorbitol sol. for inf. 5% 100ml; 500ml Human<br />

2661. Infusamin X5 infusion Amino acids mixture+Xylitol sol. for inf. 5% 100ml; 500ml Human<br />

2662. Inhacort Flunisolidum metered dose<br />

inhaler<br />

2663. Inhibace Cilazaprilum film-coated<br />

tablets<br />

2664. Inhibace Plus Cilazaprilum+<br />

Hydrochlorathiazidum<br />

film-coated<br />

tablets<br />

2665. Injekcinis vanduo Aqua ad iniectabilia solvent for<br />

parenteral use<br />

2666. Injekcinis vanduo ampule˙se Aqua ad iniectabilia solvent for<br />

parenteral use<br />

DHU<br />

DHU<br />

Solvay<br />

Pharmaceuticals<br />

250µg/dose 6ml (120doses) Boehringer<br />

Ingelheim<br />

2,5mg N28 F.Hoffmann-La<br />

Roche Ltd.<br />

5mg+12,5mg N98 F.Hoffmann-La<br />

Roche Ltd./Roche<br />

Farma S.A.<br />

5ml, 10ml amp. N5; N10 Endokrininiai<br />

preparatai<br />

5ml; 10ml amp. N5; N10 Bakteriniai<br />

preparatai<br />

2667. Innogem Gemfibrozilum caps. 300mg N100 Egis<br />

2668. Innohep Tinzaparinum natricum sol. for inj. 10 000 IU(anti-Xa)/ml 0,45ml<br />

syringe N1<br />

2669. Innohep Tinzaparinum natricum sol. for inj. 20 000 IU(anti-Xa)/ml 2ml vial<br />

N1<br />

2670. Innohep Tinzaparinum natricum sol. for inj. 10 000 IU(anti-Xa)/ml 2ml vial<br />

N1<br />

2671. Innohep Tinzaparinum natricum sol. for inj. 10 000 IU(anti-Xa)/ml 0,35ml<br />

syringe N1<br />

2672. Innohep Tinzaparinum natricum sol. for inj. 2 500 IU(anti-Xa)/0,25ml<br />

pre-filled syringe N10<br />

2673. Innohep Tinzaparinum natricum sol. for inj. 10 000 IU(anti-Xa)/ 0,5ml<br />

pre-filled syringe N2<br />

2674. Innohep Tinzaparinum natricum sol. for inj. 14 000 IU (anti-Xa) /0,7ml<br />

pre-filled syringe N2<br />

Leo<br />

Leo<br />

Leo<br />

Leo<br />

Leo<br />

Leo<br />

Leo


EN<br />

236 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2675. Innohep Tinzaparinum natricum sol. for inj. 18 000 IU (anti-Xa) /0,9ml<br />

pre-filled syringe N2<br />

2676. Insulinas-longas MK<br />

100 TV/ml (suspensija)<br />

2677. Insulinas-semilongas MK<br />

100 TV/ml (suspensija)<br />

Insulinum suis (Insulini cum<br />

zinco suspensio composita)<br />

Insulinum suis MK (Insulini<br />

cum zinco (amorphi) suspensio<br />

2678. Insuman Basal Insulinum humanum<br />

(Isophanum insulinum)<br />

2679. Insuman Basal for OptiPen Insulinum humanum<br />

(Isophanum insulinum)<br />

2680. Insuman Basal OptiSet Insulinum humanum<br />

(Isophanum insulinum)<br />

2681. Insuman Comb 25 Insulinum humanum (Insulini<br />

injectio biphasica)<br />

2682. Insuman Comb 25 for OptiPen Insulinum humanum (Insulini<br />

injectio biphasica)<br />

2683. Insuman Comb 25 OptiSet Insulinum humanum (Insulini<br />

injectio biphasica)<br />

2684. Insuman Rapid Insulinum humanum (Insulini<br />

injectio neutralis)<br />

2685. Insuman Rapid for OptiPen Insulinum humanum (Insulini<br />

injectio neutralis)<br />

2686. Insuman Rapid OptiSet Insulinum humanum (Insulini<br />

injectio neutralis)<br />

Strength Manufacturer<br />

Leo<br />

susp.for inj. 100UI/ml 10ml Endokrininiai<br />

preparatai<br />

susp. for inj. 100UI/ml 10ml vial N1 Endokrininiai<br />

preparatai<br />

susp. for inj. 100IU/ml 5ml bottle<br />

N5<br />

susp. for inj. 100IU/ml 3ml amp.<br />

N5<br />

susp.for<br />

inj.<br />

2687. Intal Inhaler Acidum cromoglicicum metered dose<br />

pressurized<br />

aerosol<br />

100 UI/ml<br />

3ml N4; N5<br />

susp. for inj. 100IU/ml 5ml bottle<br />

N5<br />

susp. for inj. 100IU/ml 3ml amp.<br />

N5<br />

susp.for inj 100 UI/ml<br />

3ml N4; N5<br />

sol. for inj. 100IU/ml 5ml bottle<br />

N5<br />

sol. for inj. 100IU/ml 3ml amp.<br />

N5<br />

susp.for inj 100 UI/ml<br />

3ml N4; N5<br />

5mg/actuation 112 actuations Fisons<br />

2688. Intal Nebuliser Solution Natrii cromoglicas inhal. sol. 20mg/2ml amp. N48 Fisons<br />

2689. Intal Plus Natrii cromoglycas+<br />

Salbutamolum<br />

2690. Interferonas alfa-2b zˇmogaus<br />

rekombinantinis<br />

2691. Interferonas gama zˇmogaus<br />

rekombinantinis<br />

Interferonum alfa-2b<br />

humanum recombinatum<br />

Interferonum gamma<br />

humanum recombinatum<br />

2692. Intetrix Tiliquinolum+Tiliquinolum (Ndodecylsulfas)+<br />

Tilbroquinolum<br />

2693. Intraglobin F Human normal<br />

immunoglobulin G<br />

2694. Intraglobin F Human normal<br />

immunoglobulin G<br />

metered dose<br />

inhaler<br />

2695. Intralipid 10 % Sojae oleum raffinatum emulsion for<br />

inf.<br />

2696. Intralipid 20 % Sojae oleum raffinatum emulsion for<br />

inf.<br />

2697. Intralipid 30 % Sojae oleum raffinatum emulsion for<br />

inf.<br />

1mg+ 100µg/dose 200 doses Fisons<br />

subst.(sol.) 0,1-0,2mg/ml 50ml;100ml;<br />

250ml;500ml<br />

subst.(sol.) 0,15-0,5mg/ml 50ml; 100ml;<br />

250ml; 500ml<br />

caps. 50mg+50mg+<br />

200mg N20<br />

sol. for inf. 50mg/ml 50ml; 100ml; 200ml<br />

bottles N1<br />

Aventis Pharma<br />

Aventis Pharma<br />

Aventis Pharma<br />

Aventis Pharma<br />

Aventis Pharma<br />

Aventis Pharma<br />

Aventis Pharma<br />

Aventis Pharma<br />

Aventis Pharma<br />

Biotechna<br />

Biotechna<br />

Beaufour Ipsen<br />

Biotest<br />

sol. for inf. 50mg/ml 10ml; 20ml amp. N1 Biotest<br />

100g/1000ml 100ml; 500ml Fresenius Kabi<br />

200g/1000ml 100ml; 250ml;<br />

500ml<br />

Fresenius Kabi<br />

300g/1000ml 250ml; 333ml Fresenius Kabi


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 237<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2698. Intrataxima Cefotaximum powder for sol.<br />

for inj.<br />

2699. Intrazoline Cefazolinum powder for sol.<br />

for inj.<br />

2700. Intron A Interferonum alfa-2b powder for sol.<br />

for inj.<br />

2701. Intron A Interferonum alfa-2b powder for sol.<br />

for inj.<br />

2702. Intron A Interferonum alfa-2b powder for sol.<br />

for inj.<br />

1g<br />

N1<br />

1g<br />

N1<br />

3MIU/vial<br />

N1<br />

5MIU/vial<br />

N1<br />

10MIU/vial<br />

N1<br />

2703. Intron A Interferonum alfa-2b sol. for inj., 15MIU/ml N1multi-dose<br />

1pen+6 needles+6 alcohol<br />

swabs<br />

2704. Intron A Interferonum alfa-2b sol. for inj. 25MIU/ml N1 multi-dose<br />

1pen+6 needles+6 alcohol<br />

swabs<br />

2705. Intron A Interferonum alfa-2b sol. for inj. 50MIU/ml N1multi-dose<br />

1pen+6 needles+6 alcohol<br />

swabs<br />

2706. Invanz Ertapenemum powder for<br />

concentrate for<br />

solution for<br />

infusion<br />

Strength Manufacturer<br />

Laboratorios Torlan<br />

Laboratorios Torlan<br />

Schering-Plough<br />

Schering-Plough<br />

Schering-Plough<br />

Schering-Plough<br />

Schering-Plough<br />

Schering-Plough<br />

1g/vial Laboratoires Merck<br />

Sharp & Dohme-<br />

Chibret<br />

2707. Invirase Saquinavirum caps. 200mg Roche<br />

2708. Invoril Enalaprilum tab. 10mg N10; N30; N100; N300 Ranbaxy<br />

2709. Invoril Enalaprilum tab. 5mg N10; N30; N100; N300 Ranbaxy<br />

2710. Ipertrofan 40 Mepartricinum enteric-coated<br />

tab.<br />

2711. Irfen-200 Quiktabs Ibuprofenum film- coated<br />

tab.<br />

2712. Iricar Cardiospermum halicacabum<br />

O<br />

2713. Iricar Cardiospermum halicacabum<br />

O<br />

2714. Iruxol Clostridiopeptidasum A +<br />

Chloramphenicolum<br />

2715. Iruxol mono Clostridiopeptidase A +Other<br />

proteases<br />

2716. ISDN-ratiopharm 20 Isosorbidi dinitras sustainedrelease<br />

caps.<br />

2717. ISDN-ratiopharm 40 Isosorbidi dinitras sustainedrelease<br />

caps.<br />

40mg<br />

N20; N30<br />

200mg<br />

N20<br />

SPA-Societa<br />

Mepha<br />

ointment 1g/10g 50g;200g DHU<br />

cream 10g/100g 50g;100g; 200g DHU<br />

ointment 0,6U+10mg/g 30g Pliva<br />

ointment 1,2U+>0,24U/g 30g Knoll<br />

20mg N50 Merckle<br />

40mg N50 Merckle<br />

2718. Isicom 100mg Levodopum+ Carbidopum tab. 100mg+ 25mg N30; N60;<br />

N100<br />

2719. Isicom 250mg Levodopum+ Carbidopum tab. 250mg+ 25mg N30; N60;<br />

N100<br />

Desitin<br />

Desitin<br />

2720. Isla-Mint Herbal Lozenges Extr. Iceland moss lozenges 100mg N30 Engelhard


EN<br />

238 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

2721. Isla-Moos Herbal Lozenges Lichenis islandicus extractum<br />

aquosum<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

lozenges 80mg N30 Soldan/Bolder/<br />

Engelhard<br />

2722. Islandine˙ kerpena Cetraria islandica herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

2723. Islandine˙ kerpena (smulkinta) Cetraria islandica herbal tea 50g; 50g (2g×25); 50g<br />

(1g×50); 16,8g (0,7g×24); 24g<br />

(1g×24); 36g (1,5g×24); 48g<br />

(2g×24)<br />

2724. ISMN 20 Stada Isosorbidi mononitras tab. 20mg N50;N100 Stada<br />

2725. ISMN 40 Stada Isosorbidi mononitras tab. 40mg N50;N100 Stada<br />

2726. ISMN 40 Stada retard Isosorbidi mononitras caps. 40mg N20;N50;<br />

N100<br />

2727. ISMN 60 Stada retard Isosorbidi mononitras caps. 60mg N20;N50;<br />

N100<br />

2728. Iso Mack Retard 20mg Isosorbidi dinitras sustainedrelease<br />

caps.<br />

2729. Iso Mack Retard 40mg Isosorbidi dinitras sustainedrelease<br />

caps.<br />

2730. Iso Mack Retard 60mg Isosorbidi dinitras sustainedrelease<br />

caps.<br />

2731. Iso Mack Spray Isosorbidi dinitras Pressurised<br />

inhalation, sol.<br />

20mg<br />

N50<br />

40mg<br />

N50<br />

60mg<br />

N50<br />

1,25mg/<br />

actuation (0,09ml) 17g(20ml)<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

2732. Isodinit 10mg Isosorbidi dinitras tab. 10mg N60 Balkanpharma-<br />

Dupnitza<br />

2733. Isodinit retard 20mg Isosorbidi dinitras prolongedrelease<br />

tab.<br />

Stada<br />

Stada<br />

Mack<br />

Mack<br />

Mack<br />

Mack<br />

20mg N60 Balkanpharma-<br />

Dupnitza<br />

2734. Iso-Eremfat 150 Isoniazidum+ Rifampicinum film-coated tab. 100mg+150mg N50;N100 Fatol<br />

2735. Isoket Isosorbidi dinitras sol. for inf. 10mg/10ml N10 Schwarz Pharma<br />

2736. Isoket (Cardiket) retard 120 Isosorbidi dinitras caps. 120mg<br />

N20<br />

2737. Isoket spray Isosorbidi dinitras spray 375mg/15ml SIFA<br />

2738. Isolong 20 Isosorbidi dinitras sustainedrelease<br />

caps.<br />

2739. Isolong 40 Isosorbidi dinitras sustainedrelease<br />

caps.<br />

20mg N60 CTS<br />

40mg N60 CTS<br />

2740. Isomonit 20 Isosorbidi mononitras tab. 20mg N30;N60; N100 Hexal<br />

2741. Isomonit 40 Isosorbidi mononitras tab. 40mg N30;N60; N100 Hexal<br />

2742. Isomonit 60 retard Isosorbidi mononitras tab. 60mg N30;N60; N100 Hexal<br />

Schwarz Pharma<br />

2743. Isoprinosine Inosiplex tab. 500mg N50 Synthelabo<br />

2744. Isoptin 80 mg Verapamilum film-coated tab. 80mg<br />

N20; N50; N100<br />

2745. Isoptin injection solution Verapamilum sol.for inj. 5mg/2ml<br />

amp. N5; N10<br />

Knoll<br />

Knoll


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 239<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2746. Isoptin mite 40 mg Verapamilum film-coated tab. 40mg<br />

N50; N100<br />

2747. Isoptin retard Verapamilum slow-release<br />

film-coated tab.<br />

2748. Isoptin RR 240 mg Verapamilum sustainedreleasefilmcoated<br />

tab.<br />

120mg<br />

N100<br />

240mg<br />

N20; N50<br />

2749. Isopto Frin Phenylephrinum eye drops 1,2mg/ml<br />

15ml<br />

2750. Isozid Isoniazidum tab. 200mg<br />

N50; N100<br />

Strength Manufacturer<br />

2751. Izoniazidas Izoniazidum tab. 0,2 g N100 Liuks<br />

2752. Izoniazido 100mg tablete˙s Isoniazidum tab. 100mg N100 Sanitas<br />

2753. Izoniazido 300mg tablete˙s Isoniazidum tab. 300mg N50; N100 Sanitas<br />

2754. Jariston (Aristoforat) Extr. Hypericum (Jonazˇole˙s<br />

sausas ekstraktas)<br />

2755. Jean Niel-Ineco Gydomasis<br />

ranku˛ balzamas<br />

Vandeninis-spiritinisglicerininis<br />

ramune˙liu˛ ir<br />

medetku˛ ekstraktas +Sibiro<br />

kedru˛ balzamas+Rektifi-kuotas<br />

spiritas<br />

2756. Jean Niel-Ineco Pe˙du˛ kremas Kedru˛ balzamas<br />

+Medetku˛ aliejus+<br />

Vit.E+Vit.A +Urea+<br />

Cinko oksidas+<br />

Šaltalankiu˛ aliejus<br />

2757. Jean Niel-Ineco Šaltalankiu˛<br />

vazelinas<br />

Vit.A+Vit.E+Kedru˛ balzamas+<br />

Saltalankiu˛ aliejus+ Medetku˛<br />

aliejus<br />

2758. Jeanine Ethinylestradiolum+<br />

Dienogestum<br />

Knoll<br />

Knoll<br />

Knoll<br />

Alcon-Couvreur<br />

Fatol<br />

caps. N30; N60; N100 Liuks<br />

balm 2%+0,1%+20%<br />

150ml<br />

cream 2%+3%+1%+<br />

1%+10%+3,35%+ 0,1% 20g<br />

ointment 1%+1%+2%+2%+2%<br />

20g<br />

sugar-coated<br />

tab.<br />

2759. Jenamazol 100 Jenapharm Clotrimazolum vaginal tab. 100mg<br />

N3<br />

2760. Jenetten Desogestrelum+<br />

Ethinylestradiolum<br />

sugar coated<br />

tab.<br />

Rekin<br />

Rekin<br />

Rekin<br />

0,03mg+2mg N21 Schering<br />

0,15mg+ 0,03mg<br />

N21; N63<br />

2761. Jodo 5 % spiritinis tirpalas Iodum+Kalii iodidum sol. 50g+20g (Ethanolum 95% et<br />

Aqua destillata ad 1000ml)<br />

10ml<br />

2762. Jodo 5 % spiritinis tirpalas BP Iodum+Kalii iodidum sol. 50mg+20mg (Aqua purificata<br />

et Ethanolum 95 % ad 1ml)<br />

10ml; 20ml<br />

2763. Jodo etanolinis tirpalas 5 % Iodum+Kalii iodidum+ Aqua<br />

destillata et Ethanolum 95%<br />

2764. Jodogels 5 % Povidonum iodinatum<br />

(Polyvidonum)<br />

Jenapharm<br />

Jenapharm<br />

Vilniaus f.f.<br />

Bakteriniai<br />

preparatai<br />

sol. 5g+ 2g+ ad 100ml 10ml Bakteriniai<br />

preparatai<br />

laboratorija Galen<br />

gel 50mg/g<br />

25g<br />

2765. Jodostin Kalii iodidum coated tab. 0,1mg N100 Polpharma<br />

2766. Johimbeks-harmonija compositum caps. N20 Liuks<br />

LMP


EN<br />

240 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2767. Jonazˇole˙s tinktūra Tinct. Hypericum perforatum tinct. 40 ml Sanitas<br />

2768. Jonazˇole˙s zˇole˙ Herb.Hyperici herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

2769. Jonazˇoliu˛ aliejinis ekstraktas Hyperici herba+ Oleum<br />

Helianthi<br />

2770. Jonazˇoliu˛ tinktūra Herb. Hyperici; (Ethanolum<br />

70%)<br />

2771. Jox Povidonum iodinatum<br />

(Polyvidonum)+ Allantoinum<br />

2772. Jox Povidonum iodinatum<br />

(Polyvidonum)+ Allantoinum<br />

2773. Joy-Rides Hyoscini hydrobro-midum<br />

(Scopolamini hydrobromidum)<br />

extr. 20g+ 80g 25ml; 50ml; 100ml KMU vaistine˙<br />

tinct. 200g; ad 1l 40ml; 50ml Korio laboratorija<br />

sol. 85mg+ 1mg/ml 100ml; 50ml IVAX-CR<br />

spray 85mg+ 1mg/ml 45ml; 30ml IVAX-CR<br />

chewable tab.<br />

(fruit flavoured)<br />

0,15mg<br />

N12<br />

2774. Jumex Selegilinum tab. 10mg N30 Chinoin<br />

2775. Jumex Selegilinum tablets 5mg N50 Chinoin<br />

2776. Junior Strength APAP Grape<br />

Tablets<br />

Paracetamolum tab. 160mg Perrigo<br />

Medeva Pharma<br />

2777. Juodojo serbento vaisiai Fruct.Ribi nigri tea Švenčioniu˛<br />

vaistazˇole˙s<br />

2778. Kabikinase Streptokinasum powder for<br />

sol.for inf.<br />

2779. Kabikinase Streptokinasum powder for sol.<br />

for inf.<br />

2780. Kabikinase Streptokinasum powder for sol.<br />

for inf.<br />

250000 IU/vial N1 Pharmacia & Upjohn<br />

750000 IU/vial Pharmacia & Upjohn<br />

1500000 IU/vial Pharmacia & Upjohn<br />

2781. Kadagiu˛ vaisiai Fructus Juniperi herbal tea 50g Švenčioniu˛<br />

vaistazˇole˙s<br />

2782. Kalcio<br />

210 mg tablete˙s<br />

2783. Kalcio chlorido 10 % tirpalas<br />

injekcijoms<br />

2784. Kalcio chlorido 10% tirpalas<br />

injekcijoms<br />

Kalcio druskos tab. N10; N30; N50; N60; N100 Liuks<br />

Calcii chloridum sol. for inj. 500mg/5ml amp. N10 Endokrininiai<br />

preparatai<br />

Calcii chloridum sol. for inj. 100mg/ml<br />

5ml amp. N5; N10<br />

2785. Kalcio dobezilatas Calcium dobesilate tab. 250 mg N30 Liuks<br />

2786. Kalcio gliukonatas 500 mg Calcii gluconas tab. 500mg<br />

N10<br />

2787. Kalcio gliukonatas ir vitaminas<br />

D3<br />

2788. Kalcio gliukonato 500mg<br />

tablete˙s<br />

2789. Kalcio gliukonato 500mg<br />

tablete˙s<br />

2790. Kalcio gliukonato tirpalas<br />

injekcijoms<br />

Calcii gluconas+<br />

Colecalciferolum<br />

tab. 500mg+100 UI N30; N50;<br />

N60<br />

Sanitas<br />

Liuks<br />

Liuks<br />

Calcii gluconas tab. 500mg N10; N50 Bakteriniai<br />

preparatai<br />

Calcii gluconas tab. 500mg<br />

N20; N50; N100<br />

Sanitas<br />

Calcii gluconas sol. for inj. 95mg/ml 10ml amp. N5 Sanitas


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 241<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2791. Kalcitoninas Calcitoninum subst. >=60 UA/mg 1-10g Endokrininiai<br />

preparatai<br />

2792. Kalcitoninas Calcitoninum subst. >=5 UI/mg<br />

1-10g<br />

2793. Kalcitoninas (lašišu˛)<br />

injekcijoms<br />

50 TV<br />

2794. Kalcitoninas (lašišu˛)<br />

injekcijoms 100 TV<br />

2795. Kalcitonino (lašišu˛) tirpalas,<br />

nosies lašai<br />

Endokrininiai<br />

preparatai<br />

Calcitoninum salmonis inj. 50IU/ml Endokrininiai<br />

preparatai<br />

Calcitoninum salmonis inj. 100IU/ml Endokrininiai<br />

preparatai<br />

Calcitoninum salmonis nasal drops, sol. 200 UI Endokrininai<br />

preparatai<br />

2796. Kalcitrinas injekcijoms Calcitoninum powder for<br />

sol.for inj.<br />

15 UA<br />

N5<br />

2797. Kalcitrino 5 TV tablete˙s Calcitoninum tab. 5 UI<br />

N20; N50<br />

2798. Kalendolis (Medetku˛ aliejus) Flor. Calendulae + Ol.<br />

Helianthi<br />

Endokrininiai<br />

preparatai<br />

Endokrininiai<br />

preparatai<br />

oleum 1 part+7 part 50ml; 100ml Bakteriniai<br />

preparatai<br />

2799. Kalendru˛ vaisiai Fruct. Coriandri subst. 20kg Švenčioniu˛<br />

vaistazˇole˙s<br />

2800. Kaletra Lopinavirum+<br />

Ritonavirum<br />

2801. Kaletra Lopinavirum+<br />

Ritonavirum<br />

2802. Kalinor Kalii citras+Kalii<br />

hydrocarbonas+ Acidum<br />

citricum<br />

2803. Kalio chloridas 750 mg Kalii chloridum prolonged<br />

release tab.<br />

caps., soft 133,3mg+<br />

33,3mg N180 (2×90); N36<br />

oral sol. 80mg+20mg/<br />

ml 60ml N5<br />

efferv. tab. 2,17g+2g+ 2,057g<br />

N15<br />

750mg<br />

N30<br />

2804. Kalio chloridas 10 % Kalii chloridum oral sol. 10g/100ml 250ml; 300ml;<br />

500ml<br />

2805. Kalio chlorido 750 mg tablete˙s Kalii chloridum tab. 750 mg N30; N60 Liuks<br />

2806. Kalio orotato tablete˙s Kalii orotas tab. 0,5g N10 Liuks<br />

Abbott Laboratories/<br />

Scherer<br />

Abbott Laboratories<br />

Knoll<br />

Glaxo Wellcome<br />

Poznan<br />

KMA vaistine˙<br />

2807. Kalio permanganatas Kalii permanganas powder 5g Bakteriniai<br />

preparatai<br />

2808. Kalio permanganatas Kalii permanganas powder 5g; 10g Vilniaus farmacijos<br />

fabrikas<br />

2809. Kalio permanganatas Kalii permanganas powder 5g Bakteriniai<br />

preparatai<br />

laboratorija Galen<br />

2810. Kalium hypermanganicum Potassium permanganate tab. 100 mg N30 Liuks<br />

2811. Kaliumiodid 200 Berlin-<br />

Chemie<br />

2812. Kalium-Magnesium-<br />

Asparaginat Berlin-Chemie<br />

Kalii iodidum (Iodum) tab. 262µg (200µg) N25; N50;<br />

N100<br />

Kalii hydroxidum+ Magnesii<br />

oxidum+DL-Aci-dum<br />

asparticum +Xylitolum<br />

sol.for inf. 3,854g+ 1,116g+ 15,16g+<br />

16,7g/1l 500ml<br />

Berlin-Chemie<br />

Berlin-Chemie<br />

2813. Kalms compos. tablets N100;N200 G.R.Lane Health<br />

Products Ltd.


EN<br />

242 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2814. Kalymin 60 N Pyridostigmini bromidum tab. 60mg N50;N100 AWD<br />

2815. Kamagel Aluminii acetotartras 10%<br />

sol.+Extr. Chamomillae flos<br />

glyc.fl.(1:1)<br />

2816. Kamillosan Mundspray Extr.flor.Chamo-millae<br />

spirituosae (1:4-4,5)+<br />

Ol.Menthae pip.+ Ol. Anisi<br />

2817. Kamillosan Salbe Extr.flor. Chamomillae siccum<br />

(4,8-6,3:1)<br />

gel 50mg+ 10mg/g 40g KRKA<br />

- 370,5mg+ 18,5mg+ 7mg/ml<br />

30ml<br />

Asta Medica<br />

ointment 10mg/g 20g Asta Medica<br />

2818. Kamiren Doxazosinum tab. 1mg N20;N30 KRKA<br />

2819. Kamiren Doxazosinum tab. 4mg N20;N30 KRKA<br />

2820. Kamiren Doxazosinum tab. 2mg N20;N30 KRKA<br />

2821. Kamistad-Gel Lidocainum+ Tinct.hamomillae<br />

(1:5,5) + Thymolum<br />

2822. Kamparinis-pipirinis linimentas Tinctura Capsici+Spiritus<br />

Camphoratus<br />

gel 2g+20g + 0,1g/100g<br />

10g<br />

2823. Kamparo 10 % aliejus Camphora oleum 100g/l<br />

30ml<br />

Stada<br />

Lin. 40ml+40ml 80ml Vilniaus f.f.<br />

2824. Kamparo 10 % aliejus BP Camphora ol. sol. 100mg/ml 30ml; 40ml Bakteriniai<br />

preparatai<br />

2825. Kamparo 10 % etanolinis<br />

tirpalas BP<br />

Sanitas<br />

Camphora ( Ethanolum 70%) sol. 100mg + ad 1ml 40ml Bakteriniai<br />

preparatai<br />

2826. Kamparo 10% tepalas Camphora ointment 10g/100g 25g; 40g; 200g Sanitas<br />

2827. Kamparo spiritas Camphora (Ethanolum 70%) sol. 10g +ad 100ml 40ml Vilniaus f.f.<br />

2828. Kamparo spiritas Camphora sol. 10g (Ethanolum 70% ad<br />

100ml)<br />

40ml; 80ml<br />

2829. Kamparo spiritas 2 % Camphora+ Ethanolum 70% sol. 2g+ad 100ml 40ml; 80ml Bakteriniai<br />

preparatai<br />

laboratorija Galen<br />

2830. Kanamycin Kanamycinum powder for inj. 1g antibiotic<br />

2831. Kanavit Phytomenadionum solution for<br />

injection<br />

2832. Kaopectate Attapulgitum tab. 750mg<br />

N20<br />

Sanitas<br />

10mg/ml 1ml amp. N5 Hoechst Biotika spol<br />

s.r.o.<br />

Pharmacia & Upjohn<br />

2833. Kaopectate Attapulgitum oral susp. 600mg/15ml 180ml Pharmacia & Upjohn<br />

2834. Kapanol Morphini sulfas caps. 20mg<br />

N20; N60<br />

2835. Kapanol Morphini sulfas caps. 50mg<br />

N20; N60<br />

2836. Kapanol Morphini sulfas caps. 100mg<br />

N20; N60<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

2837. Kapteks Captoprilum tab. 50mg N30 Merck Generics/<br />

Grindeks


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 243<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2838. Kapteks Captoprilum tab. 12,5mg N30 Merck Generics/<br />

Grindeks<br />

2839. Kapteks Captoprilum tab. 25mg N30 Merck Generics/<br />

Grindeks<br />

2840. Kaptopril tablete˙s 12,5 mg Captoprilum tab. 12,5mg N20 KRKA<br />

2841. Kaptopril tablete˙s 25 mg Captoprilum tab. 25mg N20 KRKA<br />

2842. Kaptopril tablete˙s 50 mg Captoprilum tab. 50mg N20 KRKA<br />

2843. Kaptoprilis Liuks Captoprilum tab. 25 mg<br />

N10, N30;<br />

2844. Karbamido 5 % kremas Carbamidum cream 5g/100g 30g KMA vaistine˙<br />

2845. Karčioji druska Magnesii sulfas heptahydricus powder 25g Vilniaus farmacijos<br />

fabrikas AB<br />

2846. Karčiojo kiečio (pelyno) zˇole˙ Herb. Absinthii herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

2847. Karčiojo kiečio zˇole˙<br />

(smulkinta)<br />

2848. Kardegic DL-Lysine acetylsalicylate (eq.<br />

to Acidum acetylsalicylicum)<br />

2849. Kardegic DL-Lysine acetylsalicylate (eq.<br />

to Acidum acetylsalicylicum)<br />

2850. Kardegic DL-Lysine acetylsalicylate (eq.<br />

to Acidum acetylsalicylicum)<br />

Liuks<br />

Herba Artemisiae absinthii herbal tea 50g;100g Švenčioniu˛<br />

vaistazˇole˙s<br />

powder for oral<br />

sol. in sachet<br />

powder for oral<br />

sol. in sachet<br />

powder for oral<br />

sol. in sachet<br />

540mg (eq. to 300mg) N30 Synthelabo<br />

288mg(eq. to 160mg) N30 Synthelabo<br />

180mg(eq. to 100mg) N30 Synthelabo<br />

2851. Katadolon Flupirtinum capsules 100mg N10;N30;N50 AWD. pharma<br />

GmbH & Co.KG<br />

2852. Kaugliukinas Dextranum eye drops 60mg/ml 5ml Bakteriniai<br />

preparatai<br />

2853. Keflex Cefalexinum gran. for oral<br />

susp.<br />

2854. Keflex Cefalexinum granules for<br />

oral susp.<br />

100mg/ml Eli Lilly<br />

250mg/5ml 100ml Eli Lilly Italia<br />

2855. Keflex Cefalexinum caps. 500mg N20 Eli Lilly Italia<br />

2856. Keflex Cefalexinum caps. 250mg N20 Eli Lilly Italia<br />

2857. Keflex Cefalexinum granules for<br />

oral susp.<br />

2858. Kefzol Cefazolinum powder for sol.<br />

for inj.<br />

2859. Kefzol Cefazolinum powder for sol.<br />

for inj.<br />

125mg/5ml 100ml Eli Lilly Italia<br />

500mg /vial N1 Eli Lilly<br />

1g/vial<br />

N1<br />

2860. Kenalog Triamcinolonum tab. 4mg<br />

N50<br />

2861. Kenalog 40 Triamcinolonum susp. for inj. 40mg/ml<br />

1ml amp. N5<br />

2862. Kerasal Acidum salicylicum + Ureum sol. 20mg+20mg/<br />

ml 100ml<br />

Eli Lilly<br />

KRKA<br />

KRKA<br />

Spirig Pharma


EN<br />

244 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2863. Kerasal Acidum salicylicum+ Ureum ointment 50mg+ 100mg/g 50g Spirig<br />

2864. Kestine Ebastinum film-coated tab. 10mg N10 Industrias<br />

Farmaceuticas<br />

Almirall<br />

Prodesfarma/<br />

Nycomed SEFA<br />

2865. Ketanov Ketorolacum film-coated tab. 10mg<br />

N100<br />

Ranbaxy<br />

2866. Ketanov Ketorolacum sol. for inj. 30mg/ml amp. N10 Ranbaxy<br />

2867. Ketasma Ketotifenum tab. 1mg N100 Sun<br />

2868. Ketek 400 mg Telithromycinum film-coated tab. 400mg<br />

N10; N14; N20; N100<br />

2869. Keto 100 mg Ketoprofenum film-coated tab. 100mg<br />

N20;N30;N100<br />

2870. Keto 50 mg Ketoprofenum film-coated tab. 50mg<br />

N20;N30;N100<br />

2871. Ketocef injections 1,5 g Cefuroximum powder for sol.<br />

for inj.<br />

2872. Ketocef injections<br />

250 mg<br />

2873. Ketocef injections<br />

750 mg<br />

Cefuroximum powder for sol.<br />

for inj.<br />

Cefuroximum powder for sol.<br />

for inj.<br />

1,5g/vial N5 Pliva<br />

250mg/vial N5 Pliva<br />

750mg/vial N5 Pliva<br />

Aventis Pharma<br />

Vitabalans<br />

Vitabalans<br />

2874. Ketodolac Ketorolac tromethamine sol. for inj. 30mg/ml Sanitas<br />

2875. Ketodolac Ketorolac tromethamine tab. 10mg Sanitas<br />

2876. Ketof Ketotifenum syrup 1mg/5ml 100ml; 200ml Hexal<br />

2877. Ketonal Ketoprofenum supp. 100mg N12 Lek<br />

2878. Ketonal Ketoprofenum caps. 50mg N25 Lek<br />

2879. Ketonal 5 % cream Ketoprofenum cream 50mg/g 30g;100g Lek<br />

2880. Ketonal forte Ketoprofenum tab. 100mg N20 Lek<br />

2881. Ketonal injections<br />

100 mg/2 ml<br />

Ketoprofenum sol.for inj. 100mg/2ml amp. N10; N50 Lek<br />

2882. Ketonal retard Ketoprofenum tab. 150mg N20 Lek<br />

2883. Ketotifen Ketotifenum tab. 1mg N30 Polfa Warsaw<br />

2884. Ketotifen Stada Ketotifenum caps. 1mg N20; N50; N100 Stada<br />

2885. Ketotifen Stada Ketotifenum sir. 1mg/5ml 200ml Stada<br />

2886. Ketotifen syrup Ketotifenum syrup 27,6g/100ml Troya-Pharm<br />

2887. Ketotifen-ratiopharm Sirup Ketotifenum sol. 1mg/5ml 100ml Merckle<br />

2888. Ketozol Ketoconazolum tab. 200mg<br />

N10; N20<br />

ICN Polfa Rzeszow<br />

2889. Kiauliu˛ insulinas MK Insulinum suis MK subst. >=26 UA/mg 100-1000g Endokrini-niai<br />

preparatai


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 245<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2890. Kiaulpienes šaknys Rad. Taraxaci herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

2891. Kiddi Pharmaton Calcii glycerophosphas+<br />

Thiaminum+ Riboflavinum+<br />

Pyridoxinum+<br />

Colecalciferolum+<br />

Tocoferolum+<br />

Nicotinamidum+<br />

Panthenolum+ Lysinum<br />

syrup 204mg+ 0,3mg+ 0,26mg+<br />

0,46mg+ 50IU+ 1,3mg+<br />

1,67mg+ 0,93mg+ 20mg/ml<br />

200ml<br />

Pharmaton<br />

2892. Kinedryl Moxastini teoclas+ Coffeinum tab. 25mg+ 30mg N10 Slovakofar-ma<br />

2893. Kira Extr.Hyperici perforati siccum sugar-coated<br />

tab.<br />

2894. Kit for the preparation of<br />

99mTc-colloid<br />

2895. Kit for the preparation of<br />

99mTc-DMSA<br />

2896. Kit for the preparation of<br />

99mTc-DTPA<br />

2897. Kit for the preparation of<br />

99mTc-MDP<br />

2898. Kit for the preparation of<br />

99mTc-MIBI<br />

Stannous chloride (diagnostic) powder for i.v.<br />

inj.<br />

Dimercaptosuccinic acid<br />

(diagnostic)<br />

Diethylenetriaminopentaacetic<br />

acid (diagnostic)<br />

Methylene diphosphonic acid<br />

(diagnostic)<br />

Methoxyisobutylisonitrile<br />

(diagnostic)<br />

powder for i.v.<br />

inj.<br />

powder for i.v.<br />

inj.<br />

powder for i.v.<br />

inj.<br />

powder for i.v.<br />

inj.<br />

135-225mg N50; N100 Lichtwer Pharma<br />

0,15mg N3; N6 Polatom<br />

1mg N3; N6 Polatom<br />

10mg N3; N6 Polatom<br />

5mg N3; N6 Polatom<br />

1mg N3; N6 Polatom<br />

2899. Klabax Clarithromicinum tablets 250mg N12 Ranbaxy<br />

Laboratories Limited<br />

2900. Klabax Clarithromicinum tablets 500mg N12 Ranbaxy<br />

Laboratories Limited<br />

2901. Klacid Clarithromycinum gran. for oral<br />

susp.<br />

2902. Klacid Clarithromycinum tab. 250mg<br />

N10<br />

2903. Klacid I.V. Clarithromycinum powder for sol.<br />

for inf.<br />

125mg/5ml 60ml; 100ml Abbott<br />

500mg/vial<br />

N1<br />

Abbott<br />

Abbott<br />

2904. Klacid Pediatric Suspension Clarithromycinum gran. for susp. 250mg/5ml 50ml; 100ml Abbott<br />

2905. Klacid SR Clarithromycinum modi-fiedrelease<br />

tab.<br />

2906. Klerimed 250 Clarithromycinum film-coated tab. 250mg<br />

N14<br />

2907. Klerimed 500 Clarithromycinum film-coated tab. 500mg<br />

N14<br />

500mg N5; N7 Abbott<br />

Medoche-mie<br />

Medoche-mie<br />

2908. Klevistamin Ketotifenum tab. 1mg N30 Kleva/ Sanitas<br />

2909. Kliane Estradiolum hemihydricum+<br />

Norethisteronum<br />

2910. Klimakt-Heel Sanguinaria canadensis D3 +<br />

Sepia officinalis D4+Sulfur D4<br />

+Ignatia D4+ Simarouba<br />

cedron D4+Stannum<br />

metallicum D12 +Lachesis<br />

mutus D12<br />

film-coated tab. 2mg+1mg N28; N84 (3×28) Schering<br />

tab. 30mg+30mg+30mg+ 30mg+<br />

30mg+60mg+ 90mg<br />

N50; N250<br />

Heel


EN<br />

246 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

2911. Klimaktoplan Cimicifuga D2+ Sepia D2+<br />

Lachesis D5+ Ignatia D3+<br />

Sanguinaria D2<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

tab. 25mg+ 25mg+ 25mg+ 25mg+<br />

25mg<br />

N100<br />

2912. Klimaktoplan N compos. tablets. N100 Deutsche<br />

Homoopathie Union<br />

GmbH & Co. KG<br />

2913. Klimicin Clindamycinum caps. 300mg N16; N100 Lek<br />

2914. Klimodien Dienogestum+<br />

Estradioli valeras<br />

2915. Klimonorm geltona tab.: Estradioli valeras;<br />

ruda tab.: Estradioli valeras+<br />

Levonorgestrelum<br />

film-coated tab. 2mg+2mg<br />

N28<br />

coated tab. 2mg; 2mg+ 0,15mg<br />

N21<br />

DHU<br />

Schering<br />

Schering<br />

2916. Kliogest Estradiolum+ Norethisteronum tab. 2mg+ 1mg N28 Novo Nordisk<br />

2917. Klion Metronidazo-lum sol. for inf. 500mg/100ml 100ml Gedeon Richter<br />

2918. Klion D-100 Metronidazolum+Miconazolum<br />

2919. Klofelino<br />

0,15 mg tablete˙s<br />

2920. Klofelino<br />

0,25 % tirpalas<br />

2921. Klofelino<br />

0,5 % tirpalas<br />

vaginal tab. 100mg+ 100mg<br />

N10<br />

Clonidinum tab. 0,15mg<br />

N10; N50<br />

Gedeon Richter<br />

Endokrininiai<br />

preparatai<br />

Clonidinum eye drops sol. 2,5mg/ml 1,5ml N10 Endokrininiai<br />

preparatai<br />

Clonidinum eye drops sol. 5mg/ml<br />

1,5ml N10<br />

Endokrininiai<br />

preparatai<br />

2922. Klofelino 0,125 % tirpalas Clonidinum eye drops sol. 1,25mg/ml 1,5ml N10 Endokrininiai<br />

preparatai<br />

2923. Klofelino tablete˙s Clonidini hydrochloridum tab. 0,00015 g<br />

N50<br />

2924. Klonazepa-mo tablete˙s Clonazepamum tab. 2 mg N30; N60; N100 Liuks<br />

2925. Klosterfrau Hypericum St.John's Wort dry extract 2,5-<br />

5:1<br />

2926. Klosterfrau Melisana<br />

Koncentrat<br />

Fol.Melissae+Rhiz.Helenii+<br />

Rad.Angelicae+ Rhiz.<br />

Zingiberis+Flor.Caryophylii+<br />

Rhiz.Galangae+ Fruct.Piperis<br />

nigri +Rad.Gentianae+<br />

Sem.Myristicae+<br />

Peric.Aurantii+Cort.<br />

Cinnamomi+Flor. Cassiae+<br />

Fruct.Cardamomi<br />

Liuks<br />

coated tablets 140mg N60 Artesan Pharma<br />

GmbH<br />

sol. 4,1g herbs extract in 100ml<br />

(Ethanol 66%) 95ml<br />

Klosterfrau<br />

2927. Klotrimazolis Clotrimazolum topical sol. 1g/100ml 15ml Medana Pharma<br />

Terpol<br />

2928. Klotrimazolis Clotrimazolum vagin. tab. 0,1g N10 Liuks<br />

2929. Kmyno vaisiai Fruct. Carvi herbal tea 50g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

2930. Kmynu˛ vaisiai Fruct. Carvi herbal tea 100g; 50g Švenčioniu˛<br />

vaistazˇole˙s<br />

2931. Koate-DVI Antihemophilic factor (human) powder and<br />

solvent for sol.<br />

for inj.<br />

250IU<br />

N1<br />

Bayer Corporation


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 247<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2932. Koate-DVI Antihemophilic factor (human) powder and<br />

solvent for<br />

sol.for inj.<br />

2933. Koate-DVI Antihemophilic factor (human) powder and<br />

solvent for<br />

sol.for inj.<br />

500IU<br />

N1<br />

1000IU<br />

N1<br />

Strength Manufacturer<br />

2934. Kofeino natrio benzoatas Coffeinsodium benzoate tab. 200 mg N10 Liuks<br />

2935. Kofeino natrio benzoatas<br />

200 mg<br />

2936. Kompensan Dihydroxyaluminium sodium<br />

carbonate<br />

2937. Kompensan Dihydroxyaluminium sodium<br />

carbonate<br />

Coffeini natrii benzoas tab. 200mg<br />

N10<br />

2938. Kontratusinas suaugusiems Extr.Thermopsidis sicc.+ Extr.<br />

Glycyrrhizae sicc.+ Natrii<br />

hydrocarbonas + Natrii<br />

benzoas+ Ammonii<br />

chloridum+ Ol. Anisi+<br />

Saccharum<br />

2939. Kontratusinas vaikams Extr. Althaeae sicc.+ Extr.<br />

Glycyrrhizae sicc.+ Natrii<br />

hydrocarbonas+ Natrii<br />

benzoas+ Ammonii<br />

chloridum+ Ol. Anisi+<br />

Saccharum<br />

2940. Kornam tablets<br />

2mg<br />

2941. Kornam tablets<br />

5mg<br />

tab. 340mg<br />

N20<br />

Bayer Corporation<br />

Bayer Corporation<br />

Bakteriniai<br />

preparatai<br />

Pfizer<br />

susp. 340mg/5ml 150ml Pfizer<br />

mixt. 600mg+2g+4g+4g+2g+<br />

50mg+10g 22,65g (200ml)<br />

mixt. 4g+1g+2g+2g+500mg+<br />

50mg+10g 19,55g (200ml)<br />

Terazosinum tab. 2mg<br />

N30<br />

Terazosinum tab. 5mg<br />

N30<br />

2942. Korvalol Ethyl-alfa-bromisovalerianicum+<br />

Phenobarbitalum+ Ethanolum<br />

95%<br />

2943. Korvalolis Ethyl-alfa-bromisovalerianicum+<br />

Phenobarbitalum+ Ethanolum<br />

95%<br />

2944. Kosuli˛ lengvinantis vaistazˇoliu˛<br />

mišinys Nr. 1<br />

2945. Kosuli˛ lengvinantis vaistazˇoliu˛<br />

mišinys Nr. 2<br />

Althaeae rad.+ Lichen<br />

islandicus+Tiliae flos<br />

Althaeae rad.+ Glycyrrhizae<br />

rad.+ Tiliae flos<br />

2946. Kotrimoksazols Sulfamethoxazolum+<br />

Trimethoprimum<br />

Vilniaus farmacijos<br />

fabrikas<br />

Vilniaus farmacijos<br />

fabrikas<br />

Lek<br />

Lek<br />

oral drops, sol. 20g+ 18,26g/ 1000ml 25ml Farmak<br />

sol. 20g+ 18,26g+ 580ml/ 1000ml<br />

25ml; 50ml<br />

herbal tea 50g+30g+<br />

20g 50g; 50g (2g× 25);<br />

44g (2g×22)<br />

herbal tea 45g+30g+25g+50g;<br />

50g (2g× 25);<br />

44g (2g× 2)<br />

Bakteriniai<br />

preparatai<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

tab. 400mg+80mg N20;N500 Grindex<br />

2947. Kraujazˇole˙s zˇole˙ Herb. Millefolii herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

2948. Kraujazˇoliu˛ zˇole˙ (smulkinta) Herb. Millefolii herbal tea 100g; 20kg; 16,8g (0,7g×24);<br />

24g (1g×24); 36g (1,5g×24);<br />

48g (2g×24).<br />

Švenčioniu˛<br />

vaistazˇole˙s


EN<br />

248 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

2949. Kraujospūdi˛ mazˇinantis<br />

vaistazˇoliu˛ mišinys Nr. 1<br />

Crataegi fol. cum flore +<br />

Equiseti herba+<br />

Visci albi cormus et folium<br />

Pharmaceutical<br />

form<br />

herbal tea 25g+25g+50g+<br />

50g; 50g (2g× 25);<br />

44g (2g×22)<br />

2950. Kredex Carvedilolum tab. 6,25mg<br />

N56; N98<br />

2951. Kredex Carvedilolum tab. 12,5mg<br />

N28; N98<br />

2952. Kredex Carvedilolum tab. 25mg<br />

N28; N98<br />

2953. Kreon 10 000 Pancreatinum (Amylasum+<br />

Lipasum+Proteasum)<br />

2954. Kreon 25 000 Pancreatinum (Amylasum+<br />

Lipasum+ Proteasum)<br />

2955. Ksantinolio nikotinatas<br />

150 mg<br />

2956. Ksantinolio nikotinatas<br />

150 mg BP<br />

2957. Ksantinolio nikotinato<br />

15 % tirpalas injekcijoms<br />

2958. Ksantinolio nikotinato<br />

150 mg tablete˙s<br />

caps.,hard 150mg(8000U+100000+<br />

600U)<br />

N20; N50<br />

caps.,hard 300mg (18 000 + 25 000+<br />

1 000 Ph.Eur U) N20; N50<br />

Xantinoli nicotinas tab. 150mg<br />

N60<br />

Xantinoli nicotinas tab. 150mg<br />

N60<br />

Xantinoli nicotinas sol. for inj. 150mg/ml<br />

2ml amp. N10<br />

Xantinoli nicotinas tab. 150mg<br />

N20; N50; N60<br />

2959. Kseroformo 10 % tepalas Xeroformium ointment 10g/100g<br />

25g<br />

Strength Manufacturer<br />

2960. Kuracid Ranitidinum tab. 150mg N30 GEA<br />

2961. Kuracid Ranitidinum tab. 300mg N30 GEA<br />

2962. Kuterid Betamethasonum cream 0,64mg/g 20g Lek<br />

2963. Kuterid Betamethasonum oint-ment 0,64mg/g 20g Lek<br />

2964. Kuterid G Betamethasonum+<br />

Gentamicinum<br />

2965. Kuterid G Betamethasonum+<br />

Gentamicinum<br />

2966. Kvintasols Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum+<br />

Magnesii chloridum+ Natrii<br />

acetas<br />

2967. Kwai Allii sativi bulbus sicc.pulv. sugar-coated<br />

tab.<br />

2968. Kytril<br />

3 mg/3 ml<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

SmithKline Beecham<br />

SmithKline Beecham<br />

SmithKline Beecham<br />

Solvay<br />

Pharmaceuticals<br />

Solvay<br />

Pharmaceuticals<br />

Liuks<br />

Bakteriniai<br />

preparatai<br />

Sanitas<br />

Sanitas<br />

Sanitas<br />

cream 0,64mg+ 1mg/g 15g Lek<br />

oint-ment 0,64mg+ 1mg/g 15g Lek<br />

sol. for inf. 5,26g+0,37g+0,28g+ 0,14g+<br />

4,1g/1000ml (500ml; 1000ml<br />

plastic bags with 3year<br />

shelf-life); 250ml;500ml;<br />

1000ml ‘Propyflex’ with 2 year<br />

shelf-life<br />

Granisetronum sol. for inj./inf. 3mg/3ml amp.<br />

N5<br />

2969. Kytril 1 mg Granisetronum film-coated tab. 1mg<br />

N10<br />

Grindeks<br />

100mg N100; N200; N560 Lichtwer Pharma<br />

SmithKline Beecham<br />

Pharmaceuticals<br />

SmithKline Beecham<br />

Pharmaceuticals<br />

2970. Kytril 1 mg/ml Granisetronum sol. for inj./inf. 1mg/ml amp. N5 SmithKline Beecham<br />

Pharmaceuticals<br />

2971. Lacidipino tablete˙s Lacidipinum tab. 4 mg N30; N60 Liuks


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 249<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

2972. Lacipil Lacidipinum tab. 4mg N14; N28; N56 Glaxo Wellcome<br />

2973. Lacipil 6 mg Lacidipinum film-coated tab. 6mg<br />

N28; N56<br />

Glaxo Wellcome<br />

2974. Lactulose Poli Lactulosum sirup 66,7g/100ml 200ml Poli Industria<br />

Chimica<br />

2975. Lactulose-MIP Lactulosum syrup 65g/100ml 100ml;200ml;<br />

500ml;<br />

1000ml<br />

2976. Laif 600 St. John's wort (Hyperici herba) coated tablets 612mg N20;N60;<br />

N100<br />

Chephasaar Chem.-<br />

Pharm. Fabrik GmbH<br />

Kloche Pharma<br />

Service GmbH<br />

2977. Lakišiaus zˇole˙ Herb. Bidentis herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

2978. Lakrima Artificial tears eye drops, sol. Endokrininai<br />

preparatai<br />

2979. Lakrima vit. A, vit. E Artificial tears and vitamin A,E eye drops, sol. Endokrininai<br />

preparatai<br />

2980. Laktobakterino kapsule˙s Lactobacillus plantarum<br />

8P-A3<br />

2981. Laktocinas<br />

40 TV/ ml<br />

Oxytocinum nasal drops, sol. 40UI/ml<br />

5ml<br />

caps. 4×10×9 Bakteriniai<br />

preparatai<br />

2982. Lamictal Lamotriginum tab. 200mg N56 Glaxo<br />

2983. Lamictal Lamotriginum dispersible/<br />

chewable tab.<br />

2984. Lamictal Lamotriginum dispersible/<br />

chewable tab.<br />

2985. Lamictal Lamotriginum dispersible/<br />

chewable tab.<br />

2986. Lamictal Lamotriginum dispersible/<br />

chewable tab.<br />

2987. Lamictal Lamotriginum dispersible/<br />

chewable tab.<br />

200mg<br />

N56<br />

50mg<br />

N56<br />

100mg<br />

N56<br />

5mg<br />

N56<br />

25mg<br />

N56<br />

2988. Lamictal Lamotriginum tab. 25mg<br />

N30<br />

2989. Lamictal Lamotriginum tab. 50mg<br />

N30<br />

2990. Lamictal Lamotriginum tab. 100mg<br />

N30<br />

2991. Lamictal Dispersible 2 mg Lamotriginum dispersible tab. 2mg<br />

N30<br />

2992. Lamisil 125 mg Terbinafinum scored tab. 125mg<br />

N14; N28<br />

2993. Lamisil 250 mg Terbinafinum tab. 250mg<br />

N14; N28<br />

Endokrininiai<br />

preparatai<br />

Glaxo<br />

Glaxo<br />

Glaxo<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Novartis<br />

Pharmaceuticals<br />

Novartis<br />

Pharmaceuticals


EN<br />

250 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

2994. Lamisil 1 % cream Terbinafinum cream 10mg/g<br />

15g<br />

2995. Lamisil DermGel 1 % Terbinafinum gel 10mg/g<br />

15g<br />

Strength Manufacturer<br />

Novartis Pharma/<br />

Novartis Consumer<br />

Novartis Pharma/<br />

Novartis Consumer<br />

2996. Lamisil Solution Terbinafinum topical sol. 10mg/g 30ml Novartis Pharma<br />

2997. Lamisil Spray Terbinafinum spray 10mg/g 15ml; 30ml Novartis Pharma<br />

2998. Lanicor Digoxinum sol. for inj. 0,25mg/ml amp.N10; N25 Pliva<br />

2999. Lantus<br />

100 IU/ml<br />

3000. Lantus<br />

100 IU/ml<br />

3001. Lantus for OptiPen<br />

100 IU/ml<br />

Insulin glargine sol. for inj. 100 IU/ml<br />

10ml vial N1<br />

Aventis Pharma<br />

Insulin glargine sol. for inj. 100 IU/ml 5ml vial N1 Hoechst Marion<br />

Roussel<br />

Insulin glargine sol. for inj. 100 IU/ml 3ml cartridges N5 Hoechst Marion<br />

Roussel<br />

3002. Lantus OptiSet Insulin glargine sol. for inj. 100 IU/ml 3ml pens N4;N5 Aventis Pharma<br />

Deutschland GmbH<br />

3003. Lanvis tablets Tioguaninum tab. 40mg N25 Wellcome<br />

3004. Lanzul Lansoprazolum caps. 30mg N14 KRKA<br />

3005. L-ascorbic acid Acidum ascorbicum subst. Basf Health and<br />

Nutrition<br />

3006. Lasix Retard Furosemidum prolonged<br />

release caps.<br />

60mg<br />

N30; N100<br />

Aventis Pharma<br />

3007. Lasolnasal Plus Tramazolinum nasal spray 1,18mg/ml 10ml Boehringer<br />

Ingelheim<br />

3008. Lasolvan Ambroxolum syrup 15mg/5ml 100ml Boehringer<br />

Ingelheim<br />

3009. Lasolvan Ambroxolum sol. 15mg/2ml 100ml Boehringer<br />

Ingelheim<br />

3010. Lasolvan Ambroxolum tab. 30mg N20;N50 Boehringer<br />

Ingelheim<br />

3011. Lasolvan Retard Ambroxolum sustainedrelease<br />

caps.<br />

3012. L-Asparaginaze Asparaginasum lyophilized<br />

powder for inj.<br />

75mg<br />

N20; N50<br />

Boehringer<br />

Ingelheim<br />

10 000 UI/ bottles N1 Grindeks<br />

3013. Lastet Etoposidum inj. 100mg/5ml N10 Nippon Kayaku<br />

3014. Lastet Etoposidum caps. 25mg<br />

N10; N20; N40<br />

3015. Lastet Etoposidum caps. 100mg<br />

N10; N20; N40<br />

3016. Lastet Etoposidum caps. 50mg<br />

N10; N20; N40<br />

3017. Laticort cream 0,1 % Hydrocortisonum cream 1mg/g 15g Jelfa<br />

3018. Laticort lotion 0,1 % Hydrocortisonum lotion 1mg/g 20ml Jelfa<br />

3019. Laticort ointment 0,1 % Hydrocortisonum ointment 1mg/g 15g Jelfa<br />

Nippon Kayaku<br />

Nippon Kayaku<br />

Nippon Kayaku


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 251<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3020. Laxygal Natrii picosulfas oral drops, sol. 75mg/10ml 10ml IVAX-CR<br />

3021. Lecrolyn Natrii cromoglicas eye drops, sol. 40mg/ml single dose 0,25ml<br />

N20; N60<br />

3022. Lecrolyn Natrii cromoglicas eye drops, sol. 40mg/ml 5ml; 10ml Santen<br />

3023. Lecrolyn Natrii cromoglicas eye drops, sol. 20mg/ml 10ml Santen<br />

3024. Lecrolyn Natrii cromoglicas eye drops, sol. 20mg/ml single dose 0,25ml<br />

N20; N60<br />

3025. Lederspan Triamcinolonum susp. for inj. 20mg/ml 1ml N1; 5ml N1 Lederle Parenterals/<br />

Wyeth Medica<br />

Ireland<br />

3026. Ledoxina<br />

200 mg<br />

3027. Ledoxina<br />

500 mg<br />

Cyclophosphamidum lyophilized<br />

powder for inj.<br />

Cyclophosphamidum lyophilized<br />

powder for inj.<br />

Santen<br />

Santen<br />

200mg/bottle N1 Lemery<br />

500mg/bottle N1 Lemery<br />

3028. Legalon 140 Silymarin, calk. as Silibinin caps. 140mg as 173-186,7mg N30;<br />

N60; N100<br />

3029. Lekoklar<br />

250 mg tablete˙s<br />

3030. Lekoklar<br />

500 mg tablete˙s<br />

3031. Lekoptin coated tablets<br />

40 mg<br />

3032. Lekoptin coated tablets<br />

80 mg<br />

3033. Lemocin citron Lidocainum+ Tyrothricinum+<br />

Cetrimonii bromidum<br />

3034. Lemocin sour cherry (griotte) Lidocainum+ Tyrothricinum+<br />

Cetrimonii bromidum<br />

Clarithromycinum film-coated tab. 250mg<br />

N10; N14<br />

Clarithromycinum film-coated tab. 500mg<br />

N14<br />

Verapamili hydrochloridum coated tab. 40mg N50 Lek<br />

Verapamili hydrochloridum coated tab. 80mg N50 Lek<br />

3035. Lendacin vials 1 g Ceftriaxonum powder for sol.<br />

for inj.<br />

3036. Lendacin vials 250 mg Ceftriaxonum powder for sol.<br />

for inj.<br />

3037. Lendormin Brotizolamum tab. 0,25mg<br />

N10<br />

3038. Leponex 100 mg Clozapinum tab. 100mg<br />

N50<br />

3039. Leponex 25 mg Clozapinum tab. 25mg<br />

N50<br />

3040. Leptandra compositum Leptandra D2+Quassia amara<br />

D3 +Podophyllum peltatum<br />

D3+Arsenicum album D4+<br />

Carbo vegetabilis D10+<br />

Niccolum metallicum D10+<br />

Phosphorus D6 (Ethanolum<br />

35vol.-%)<br />

Madaus<br />

lozenges 1mg+ 4mg+ 2mg N24 Novartis Urunleri<br />

lozenges 1mg+ 4mg+ 2mg N24 Novartis Urunleri<br />

Lek<br />

Lek<br />

1g/vial N1;N5;N10;N50 Lek<br />

250mg/vial N1;N5;N10;N50 Lek<br />

drops 1g+1g+1g+1g+1g+1g+1g/<br />

100g<br />

30ml; 100ml<br />

3041. Lercapin Lercanidipini hydrochloridum film-coated tab. 10mg<br />

N7; N14; N28<br />

Boehringer<br />

Ingelheim<br />

Novartis<br />

Pharmaceuticals<br />

Novartis<br />

Pharmaceuticals<br />

Heel<br />

Berlin-Chemie<br />

3042. Lerin 10 Enalaprilum tablets 10mg Lachema, a.s.


EN<br />

252 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3043. Lerin 20 Enalaprilum tablets 20mg Lachema, a.s.<br />

3044. Lerin 5 Enalaprilum tablets 5mg Lachema, a.s.<br />

3045. Lescol Fluvastatinum caps. 20mg<br />

N28; N98<br />

3046. Lescol Fluvastatinum caps. 40mg<br />

N28; N98<br />

3047. Lescol XL 80 mg Fluvastatinum prolongedrelease<br />

tab.<br />

3048. Lespenephryl Tinct. Lespedesa Capitata+Ol.<br />

Anisi solubilis + Ethanolum<br />

96%<br />

80mg<br />

N28<br />

oral sol. 15ml+ 0,25ml+ 62mg/100ml<br />

120ml<br />

3049. Letizen Cetirizini dihydrochloridum film-coated tab. 10mg N20;N30 KRKA<br />

3050. Letizen Cetirizini dihydrochloridum film-coated tab. 10mg N7;N10 KRKA<br />

3051. Letizen Cetirizinum oral solution 1mg/ml 120ml KRKA<br />

3052. Leucomax 150 Molgramostimum powder and<br />

solvent for sol.<br />

for inj.<br />

3053. Leucomax 400 Molgramostimum powder and<br />

solvent for sol.<br />

for inj.<br />

3054. Leucovorin Ca Lachema 10 inj.<br />

sicc.<br />

3055. Leucovorin Ca Lachema 25 inj.<br />

sicc.<br />

Acidum folicum powder for sol.<br />

for inj.<br />

Acidum folicum powder for sol.<br />

for inj.<br />

150µg/vial<br />

N1<br />

400µg/vial<br />

N1<br />

Novartis<br />

Farmaceutica<br />

Novartis<br />

Farmaceutica<br />

Novartis Pharma<br />

UCB Pharma<br />

10mg/vial N10 Lachema<br />

25mg/vial N1; N10 Lachema<br />

3056. Leucovorin Calcium Calcii folinas sol. for inj. 10mg/ml 5ml N5; 10ml; 30ml<br />

N1<br />

3057. Leucovorin-Teva Calcii folinas sol. for inj. 10mg/ml<br />

5ml<br />

3058. Leukeran Chlorambucilum tab. 2mg<br />

N25<br />

3059. Leukeran Chlorambucilum tab. 5mg<br />

N25<br />

3060. Levomecolum Chloramphenicolum ung. 25 g, 100 g Liuks<br />

3061. Levomekolio tepalas Chloramphenicolum+<br />

Methyluracilum<br />

ointment 0,75g+ 4g/100g 30g;50g;<br />

100g<br />

3062. Levomicetinas 500 mg Chloramphenicolum tab. 500mg<br />

N10<br />

Nycomed Austria<br />

Nycomed Austria<br />

David Bull<br />

Abic<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

KMA vaistine˙<br />

3063. Levomicetino 0,25 % tirpalas Chloramphenicolum eye drops, sol 2,5mg/ml 1,5ml; 5ml Endokrini-niai<br />

preparatai<br />

3064. Levomicetino 500 mg tablete˙s Chloramphenicolum tab. 500mg<br />

N10; N20; N50<br />

3065. Levopront Levodropropizinum syrup 60mg/10ml 60ml; 120ml Mack<br />

3066. Levovist<br />

2,5 g<br />

Galactose (microparticles) powder for<br />

susp. for i.v. inj.<br />

2,5g<br />

N1<br />

Liuks<br />

Sanitas<br />

Schering


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 253<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3067. Levovist 4 g Galactose (microparticles) powder for<br />

susp. for i.v. inj.<br />

3068. Lexotanil Bromazepamum tab. 1,5mg<br />

N30<br />

3069. Lexotanil Bromazepamum tab. 3mg<br />

N30<br />

4g<br />

N1<br />

Strength Manufacturer<br />

Schering<br />

3070. Libexin Prenoxdiazinum tablets 100mg N20 Chinoin<br />

3071. Lidaze˙/ Lydasum Hialuronidaze˙ subst. 64VV/30mg 2000g G.Miezˇio ir<br />

A.Dzikaraite˙s<br />

komanditine˙ ŪB<br />

3072. Lidevin Disulfiramum+<br />

Nicotinamidum+<br />

Adeninum<br />

tab. 500mg+0,3mg+0,5mg<br />

N20<br />

3073. Lidocain Lidocainum sol. for inj. 20mg/ml 2ml N100; 10ml Egis<br />

3074. Lidocain Lidocainum sol. for inj. 200mg/2ml N10 Egis<br />

3075. Lidocain 10 % spray Lidocainum spray 3,8g/vial (Ethanolum<br />

96 % 27,3 g/ vial 38g<br />

3076. Lidokaina hidrohlorids 1 %<br />

škidums injekcijam<br />

3077. Lidokaina hidrohlorids 2 %<br />

škidums injekcijam<br />

3078. Lidokaino 1 % tirpalas<br />

injekcijoms<br />

3079. Lidokaino 2 % tirpalas<br />

injekcijoms<br />

Roche<br />

Roche<br />

A.J.C. Pharma<br />

Lidocainum sol. for inj. 20mg/2ml amp. N10 Grindeks<br />

Lidocainum sol. for inj. 100mg/5ml amp.N10 Grindeks<br />

Lidocainum sol. for inj. 10mg/ml<br />

20ml N5<br />

Lidocainum sol. for inj. 20mg/ml<br />

20ml N5<br />

3080. Lidokaino 5 % tepalas Lidocainum ointment 5g/100g<br />

30g<br />

3081. Lidokaino hidrochlorido<br />

1 % tirpalas injekcijoms<br />

3082. Lidokaino hidrochlorido<br />

2 % tirpalas injekcijoms<br />

3083. Lidokaino hidrochlorido<br />

2 % tirpalas injekcijoms<br />

Egis<br />

Delta/<br />

Ilsanta<br />

Delta/<br />

Ilsanta<br />

KMA vaistine˙<br />

Lidocaini hydrochloridum sol. for inj. 10mg/ml 20ml;50ml Pharmamed /Ilsanta<br />

Lidocainum sol. for inj. 20mg/ml 2ml; 10ml amp. N5;<br />

N10<br />

Sanitas<br />

Lidocaini hydrochloridum sol. for inj. 20mg/ml 20ml;50ml Pharmamed /Ilsanta<br />

3084. Lidoposterin Lidocainum ointment 50mg/g 25g Dr. Kade<br />

Pharmazeutische<br />

Fabrik GmbH<br />

3085. Liepos zˇiedai Flor.Tiliae herbal tea 50g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

3086. Liepu˛ zˇiedai (smulkinti) Flor. Tiliae herbal tea 50g; 50g (2g×25); 50g<br />

(1g×50); 16,8g(0,7g×24);<br />

24g(1g×24); 36g(1,5g×24);<br />

48g(2g×24).<br />

3087. Liese˙jimo kurso metu<br />

vartojamas vaistazˇoliu˛ mišinys<br />

‘Gracija-1’<br />

Frangulae cortex+<br />

Taraxaci radix+<br />

Menthae piperitae herba<br />

herbal tea 40g+30g+30g/<br />

100g 40g (2g×20)<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Acorus Calamus<br />

3088. Lignocaine hydrochloride Lidocainum sol. for inj. 20mg/ml 10ml amp. N50 Polfa Warsaw<br />

3089. Lignocaine hydrochloride Lidocainum sol. for inj. 10mg/ml 2ml amp. N10; N50 Polfa Warsaw


EN<br />

254 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3090. Lignocaine hydrochloride Lidocainum sol. for inj. 10mg/ml 10ml amp. N50 Polfa Warsaw<br />

3091. Lignocaine hydrochloride Lidocainum sol. for inj. 10mg/ml 10ml vials N5 Polfa Warsaw<br />

3092. Lignocaine hydrochloride Lidocainum sol. for inj. 20mg/ml 2ml amp. N10; N50 Polfa Warsaw<br />

3093. Lignocaine hydrochloride Lidocainum sol. for inj. 20mg/ml 10ml vials N5 Polfa Warsaw<br />

3094. Lignocaine hydrochloride Lidocainum sol. for inj. 20mg/ml 20ml vials N5 Polfa Warsaw<br />

3095. Lignocaine hydrochloride Lidocainum sol. for inj. 10mg/ml 20ml vials N5 Polfa Warsaw<br />

3096. Lignospan 2% Special Lidocainum + Adrenalinum local or<br />

regional<br />

submucosal<br />

intraoral inj.<br />

2%+0,00125% 1,8ml cartridge<br />

N50<br />

3097. Linamon Acidum ascorbicum lozenges 100mg N30 KRKA<br />

Septodont<br />

3098. Lincocin Lincomycinum caps. 500mg N12; N20; N100 Pharmacia & Upjohn<br />

3099. Lincocin Lincomycinum sol. for inj. or<br />

inf.<br />

300mg/ml<br />

2ml vial N1<br />

3100. Lindron Acidum alendronicum tab. 10mg<br />

N14; N28<br />

3101. Lindynette 20 Gestodenum+<br />

Ethinylestradiolum<br />

3102. Lindynette 30 Gestodenum+<br />

Ethinylestradiolum<br />

3103. Linex Lyophilised bacteria:<br />

Bifidobacterium infants v.<br />

liberorums+ Lactobacillus<br />

acidophilus+ Streptococcus<br />

feacium<br />

coated tab. 0,075mg+ 0,020mg N21;<br />

N3×21<br />

coated tablets 0,075mg+ 0,030mg N21;<br />

N3×21<br />

Pharmacia & Upjohn<br />

KRKA<br />

caps. not less than 12 mln. N16 Lek<br />

3104. Linkomicino hidrochloridas Linkomicinum kaps. 0,25g N20 Liuks<br />

Gedeon Richter Ltd.<br />

Gedeon Richter Ltd.<br />

3105. Lino se˙klos Sem. Lini 200g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

3106. Linola Acidum linoleicum+ Acidum<br />

ricinoleicum<br />

3107. Linola Fett N Acidum linoleicum+ Acidum<br />

ricinoleicum<br />

cream 0,13g+ 0,5g/100g 50g Wolff<br />

cream 2,1mg+ 8mg/g 50g Wolff<br />

3108. Linola sept Clioquinolum cream 0,5g/100g 15g; 50g Wolff<br />

3109. Linola urea Ureum cream 12g/100g 75g; 150g Wolff<br />

3110. Linoladiol N Estradiolum cream 10mg/100g 25g; 50g; 100g Wolff<br />

3111. Linoladiol-HN Prednisolonum+ Estradiolum cream 400mg+ 5mg/100g 25g; 50g Wolff<br />

3112. Linola-Fett N Olbad Diflussiges paraffin+<br />

(Hexadecyl, octadecil)-2-ethylhexanoat-Isopro-pylmyristat+<br />

alfa-Dodecyl, tetra-decylomega-hydroxypoly(oxyethylen)-4,5poly(oxypropylen)-5+alfadodecyl-omega-hydroxypoly(oxyethylen)-2<br />

bath oil 48g+44g+ 4g+6g/100g 200ml;<br />

400ml; 800ml<br />

Wolff


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 255<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3113. Linola-H-compositum N Prednisolonum+ Neomycinum cream 400mg+ 300mg/100g 25g;<br />

50g; 250g<br />

Strength Manufacturer<br />

3114. Linola-HN Prednisolonum cream 400mg/100g 25g; 50g; 250g Wolff<br />

3115. Linu˛ se˙klos Semina Lini sausi se˙menys 200g Švenčioniu˛<br />

vaistazˇole˙s<br />

3116. Liobilio<br />

200 mg tablete˙s<br />

Liobilum enterosoluble<br />

tab.<br />

200mg<br />

N30; N50<br />

Wolff<br />

Endokrininiai<br />

preparatai<br />

3117. Liobilis Liobilum subst. 49-65% 0,1-1kg Endokrininiai<br />

preparatai<br />

3118. Lioton 1000 gel Heparinum natricum gel 100 000IU /100g 50g; 30g Menarini<br />

3119. Lipanor Ciprofibratum caps. 100mg<br />

N30<br />

Sanofi Winthrop<br />

3120. Lipanthyl 200 M Fenofibratum caps. 200mg N30 Laboratoires<br />

Fournier<br />

3121. Lipofundin MCT/LCT<br />

10 %<br />

3122. Lipofundin MCT/LCT<br />

20 %<br />

Sojae oleum+ Triglycerida<br />

saturata media<br />

Sojae oleum+ Triglycerida<br />

saturata media<br />

emulsion for<br />

inf.<br />

emulsion for<br />

inf.<br />

3123. Lipo-Merz retard Etofibratum caps. 500mg<br />

N50<br />

3124. Lipostat Pravastatinum tab. 20mg<br />

N28; N30<br />

3125. Lipostat Pravastatinum tab. 40mg<br />

N30<br />

50g+50g/ 1000ml 100ml;<br />

250ml;500ml<br />

100g+100g/1000ml 100ml;<br />

250ml;500ml<br />

3126. Liquid Paraffin Paraffin oil subst. 180kg net/<br />

199kg gross drums<br />

Braun Melsungen<br />

Braun Melsungen<br />

Merz+Co<br />

3127. Liskantin Primidonum tab. 250mg N50;N100 Desitin<br />

3128. Liugolio purškalas Iodi + Kalii iodidi aer. 1+ 2+ glyceroli<br />

85 % ad 100 g<br />

3129. Liugolio tirpalas su glicerinu Iodum+<br />

Kalii iodidum+<br />

Glycerolum<br />

sol. 1g+2g+94g/<br />

100g 25ml<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Schumann Sasol<br />

Bakteriniai<br />

preparatai<br />

Vilniaus f.f.<br />

3130. Livial Tibolonum tab. 2,5mg N28; N84 Organon<br />

3131. Livol Vitamin B-Strong Thiaminum+ Riboflavinum+<br />

Pyridoxinum+<br />

Nicotinamidum+ Acidum<br />

pantothenicum<br />

3132. Livol Vitamin C 400 mg-<br />

Strong<br />

tab. 15mg+ 15mg+ 15mg+ 60mg+<br />

27mg N100<br />

Acidum ascorbicum chewable tab. 400mg<br />

N50<br />

Dansk Droge<br />

Dansk Droge<br />

3133. Livol Vitamin E-Strong Tocopherolum tab. 74mg (110IU) N50 Dansk Droge<br />

3134. Livostin Levocabastinum eye drops,susp. 0,5mg/ml<br />

4ml<br />

3135. Livostin Levocabastinum nasal<br />

spray,susp.<br />

0,5mg/ml<br />

10ml<br />

KRKA<br />

KRKA


EN<br />

256 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3136. Lizinoprils-Grindex Lisinoprilum tablets 20mg N14 Public Joint Stock<br />

Company ‘Grindeks’<br />

3137. Lizinoprils-Grindex Lisinoprilum tablets 10mg N14 Public Joint Stock<br />

Company ‘Grindeks’<br />

3138. Loceryl Amorolfinum nail lacquer<br />

(ethanol base)<br />

5g/100ml 2,5ml; 5ml Roche<br />

3139. Lodronat 520 Acidum clodronicum film-coated tab. 520mg N60 Boehringer<br />

Mannheim<br />

3140. Loette Levonorgestrelum+<br />

Ethinylestradiolum<br />

3141. Logest Gestodenum+<br />

Ethinylestradiolum<br />

3142. Logimax forte Felodipine+<br />

Metoprolol succinate<br />

3143. Logimax forte Felodipine+ Metoprolol<br />

succinate<br />

film-coated tab.:<br />

pink and white<br />

pink tab.: 0,1mg+<br />

0,02mg, white tab. do not<br />

contain active ingredients N28;<br />

N3×28<br />

Wyeth Medica<br />

coated tab. 75µg+20µg N21 Schering<br />

extended-release<br />

tab.<br />

extended-release<br />

tab.<br />

3144. Lokren 20 mg Betaxololum scored filmcoated<br />

tab.<br />

3145. Lomexin Fenticonazolum sprinkling<br />

powder<br />

10mg+95mg N30;100 Astra<br />

5mg+50mg N30;100 Astra<br />

20mg<br />

N28<br />

2g/100g<br />

50g<br />

Synthelabo<br />

Recordati<br />

3146. Lomexin Fenticonazolum spray 2g/100ml 30ml Recordati<br />

3147. Lomexin Fenticonazolum vaginal ovul. 200mg<br />

N3<br />

Recordati<br />

3148. Lomexin Fenticonazolum cream 2g/100g 30g Recordati<br />

3149. Lomexin Fenticonazolum vaginal ovul. 600mg<br />

N1<br />

Recordati<br />

3150. Lomexin Fenticonazolum vaginal cream 2g/100g 78g Recordati<br />

3151. Lomilan Loratadinum tab. 10mg N20 Lek<br />

3152. Lomilan Loratadinum oral susp. 1mg/ml 120ml Lek<br />

3153. Lopedium Loperamidum caps. 2mg<br />

N30<br />

3154. Lopedium Express Loperamidum caps. 2mg<br />

N10<br />

Salutas Pharma<br />

Salutas Pharma<br />

3155. Loperamid Loperamidum tab. 2mg N30 Polfa Warsaw<br />

3156. Loperamida hidrohlorids Loperamidum caps. 2mg<br />

N10<br />

3157. Loperamido 2 mg tablete˙s Loperamidum tab. 2 mg N10; N30 Liuks<br />

3158. Loperamid-ratiopharm<br />

Filmtabletten<br />

Generics/<br />

Grindex<br />

Loperamidum film-coated tab. 2mg N10 Merckle<br />

3159. Lorabid Loracarbefum caps. 200mg N10 Eli Lilly<br />

3160. Lorabid Loracarbefum gran. for oral<br />

susp.<br />

100mg/5ml 50ml Eli Lilly


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 257<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3161. Lorabid Loracarbefum gran. for oral<br />

susp.<br />

Strength Manufacturer<br />

200mg/5ml 50ml Eli Lilly<br />

3162. Lorabid Loracarbefum caps. 400mg N10 Eli Lilly<br />

3163. Lorafen Lorazepamum coated tab. 2,5mg<br />

N25<br />

3164. Lorafen Lorazepamum coated tab. 1mg<br />

N25<br />

Polfa Tarchomin<br />

Polfa Tarchomin<br />

3165. Loratadin 10-SL Loratadinum tab. 10mg N10;N30 Slovakofarma<br />

3166. Loratadinum Galena Loratadinum tab. 10 mg N10; N30 Liuks<br />

3167. Loratin Loratadinum tab. 10mg N30 Salutas<br />

3168. Loratin Express Loratadinum tab. 10mg<br />

N10<br />

3169. Lorazepamo tablete˙s Lorazepamum tab. 1 mg N25 Liuks<br />

3170. Lorazepamo tablete˙s Lorazepamum tab. 2,5 mg N25 Liuks<br />

3171. Loridin Rapitab Loratadinum dispersible<br />

tablets<br />

3172. Lorinden A Flumethasoni pivalas+ Acidum<br />

salicylicum<br />

3173. Lorinden C Flumethasoni pivalas+<br />

Clioquinolum<br />

3174. Lorinden C Flumethasoni pivalas+<br />

Clioquinolum<br />

3175. Lorinden N Flumetasonum+<br />

Neomycinum<br />

3176. Lorinden T Flumetasonum+<br />

Pix Lithanthracis+<br />

Acidum salicylicum<br />

Salutas<br />

10mg N100 Cadila Healthcare<br />

Limited<br />

ointment 0,2mg+30mg/g 15g Jelfa<br />

cream 0,2mg+ 30mg/g 15g Jelfa<br />

ointment 0,2mg+ 30mg/g 15g Jelfa<br />

cream 0,2mg+5mg/g 15g Jelfa<br />

ointment 0,2mg+15mg+ 10mg/g<br />

15g<br />

3177. Lorista Losartanum film-coated tab. 50mg<br />

N28<br />

3178. Loritmik 160 Sotalolum tab. 160mg N20; N50 KRKA<br />

3179. Loritmik 80 Sotalolum tab. 80mg N20; N50 KRKA<br />

3180. Losec Omeprazolum powder for sol.<br />

for inf.<br />

40mg/vial<br />

N5<br />

3181. Losec Omeprazolum caps., hard 10mg N14; N28; N56 Astra<br />

3182. Losec Omeprazolum caps., hard 20mg N7;N14;N28 Astra<br />

3183. Losec Omeprazolum caps., hard 40mg N7;N14;N28 Astra<br />

Jelfa<br />

KRKA<br />

AstraZeneca<br />

3184. Losec MUPS Omeprazolum magnesium tab. 10mg N14; N28; N100 AstraZeneca<br />

3185. Losec MUPS Omeprazolum magnesium tab. 20mg N14; N28; N100 AstraZeneca<br />

3186. Losec MUPS Omeprazolum magnesium tab. 40mg N14; N28; N100 Astra


EN<br />

258 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3187. Lovasterol Lovastatinum tablets 10mg N30 Pharmaceutical<br />

Works ‘Polpharma’<br />

S.A.<br />

3188. Lovasterol Lovastatinum tablets 20mg N28 Pharmaceutical<br />

Works ‘Polpharma’<br />

S.A.<br />

3189. Lovasterol Lovastatinum tablets 40mg N30 Pharmaceutical<br />

Works ‘Polpharma’<br />

S.A.<br />

3190. L-Thyroxin 100 Berlin-Chemie Levothyroxinum natricum tab. 100µg N50; N100 Berlin-Chemie<br />

3191. L-Thyroxin 50 Berlin-Chemie Levothyroxinum natricum tab. 50µg N50; N100 Berlin-Chemie<br />

3192. Lucrin Depot Leuprorelinum powder and<br />

solvent for<br />

susp. for. inj.<br />

3193. Luffa comp.-Heel Luffa operculata D4+Luffa<br />

operculata D12+ Luffa<br />

operculata D30+Thryallis<br />

glauca D4+ Thryallis glauca<br />

D12 +Thryallis glauca D30+<br />

Histaminum D12+<br />

Histaminum D30+<br />

Histaminum D200+ Sulfur<br />

D12+ Sulfur D30+ Sulfur<br />

D200<br />

3194. Luffa compositum Heel Aralia racemosa D1+Arsenum<br />

jodatum D8+ Lobelia inflata<br />

D6+ Luffa operculata D12<br />

3,75mg/vial+amp. of solvent<br />

(Carboxymethyl-cellulosum<br />

natricum 10mg/ 2ml+<br />

D-Mannitolum 100mg/2ml+<br />

Polysorbatum 80 2mg/2ml)<br />

N1<br />

nasal spray 10g+10g+ 10g+10g+ 10g+<br />

10g+ 5g+5g+5g+ 5g+5g+<br />

5g/100g 20ml<br />

tab. 25mg+ 25mg+ 25mg+ 25mg<br />

N50;N250<br />

Abbott Laboratories<br />

3195. Luivac Lysatum bacteriale mixtum tab. 3mg N28 Sankyo Pharma<br />

3196. Luminal Phenobarbitalum natricum+<br />

Ethanolum 96%<br />

3197. Lunelle Medroxiprogesteronum+<br />

Estradiolum<br />

Heel<br />

Heel<br />

sol. for inj. 219mg+ 83mg/ml N5 Pharma Hameln/<br />

Desitin<br />

suspension for<br />

injection<br />

3198. Lusopress Nitrendipinum tab. 20mg<br />

N28<br />

25mg+5mg 0,5ml vial N1 Pharmacia & Upjohn<br />

Company<br />

Instituto Luso<br />

Farmaco<br />

3199. Lutenyl Nomegestrolum scored tab. 5mg N10 Theramex<br />

3200. Luveris 75 Lutropinum alfa powder and<br />

solvent for sol.<br />

for inj.<br />

3201. Lymphomyosot Myosotis arvensis D3+<br />

Veronica officinalis D3+<br />

Teucrium scorodonia D3+<br />

Pinus sylvestris D4+Gentiana<br />

lutea D5+ Equisetum hyemale<br />

D4+Sarsaparilla D6+<br />

Scrophularia nodosa D3+<br />

Juglans regia D3+Calcium<br />

phosporicum D12+Natrium<br />

sulfuricum D4+ Fumaria<br />

officinalis D4+. . .<br />

75UI/vial+ amp./vial of solvent<br />

N1; N3; N10<br />

drops 5g+5g+5g+<br />

5g+5g+5g+<br />

5g+5g+5g+<br />

5g+5g+5g/100g (Ethanolum<br />

35 tūrio %) bottles 30ml;<br />

100ml<br />

Industria<br />

Farmaceutica<br />

Serono/ Laboratoires<br />

Serono<br />

Heel


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 259<br />

No. Commercial name General name<br />

3202. Lymphomyosot Myosotis arvensis D3+<br />

Veronica officinalis D3 +<br />

Teucrium scorodonia D3 +<br />

Pinus sylvestris D4+ Gentiana<br />

lutea D5 + Equisetum<br />

hyemaleD4+Sarsaparilla D6+<br />

Scorphularia nodosa D3+<br />

Juglans regia D3+ Calcium<br />

phosphoricum D12 + Natrium<br />

sulfuricum D4+ Fumaria<br />

officinalis D4+. . .<br />

3203. Lymphozil Extr. rad. Echinaceae pallida<br />

spir. sicc. (4:1)+<br />

Faex medicinalis+<br />

Calcium carbonicum D6+<br />

Fucus vesiculosus D5+Silicea<br />

D4+Lachesis D6+Thiamini<br />

hydrochloricum 0,015<br />

3204. Lymphozil forte Extr. rad. Echinaceae pallida<br />

spir. sicc.(4:1)+<br />

Faex medicinalis+<br />

Calcium carbonicum+ Extr.<br />

Fuci vesiculosi spir. sicc<br />

(10:1)+Silicea+ Lachesis+<br />

Thiamini hydrochloridum<br />

3205. Lysthenon 0,1 g/5 ml —<br />

ampoules<br />

3206. Maalox Aluminii hydroxidum+<br />

Magnesii hydroxidum<br />

3207. Maalox Aluminii hydroxidum+<br />

Magnesii hydroxidum<br />

3208. Maalox Aluminii hydroxidum+<br />

Magnesii hydroxidum<br />

Pharmaceutical<br />

form<br />

Suxamethonii chloridum sol. for inj. or<br />

inf.<br />

3209. Mab Campath Alemtuzumab concentrate for<br />

solution for<br />

infusion<br />

tab. 15mg+15mg+15mg+ 15mg+<br />

15mg+15mg+ 15mg+15mg+<br />

15mg+ 15mg+15mg+15mg<br />

N50; N250<br />

tab. 1,5mg+10mg+ 10mg+0,5mg+<br />

7,5mg+2,5mg+7,5mg<br />

N200<br />

tab. 4mg+50mg+ 0,02mg+0,1mg+<br />

1µg+1µg+ 0,1mg<br />

N40<br />

Strength Manufacturer<br />

Heel<br />

Redel<br />

Redel<br />

100mg/5ml amp.N5 Nycomed Austria<br />

oral susp. 523,5mg+ 598,5mg/ 15ml<br />

sachet N30<br />

Le Nigen Pharma<br />

chewable tab. 400mg+ 400mg N40 Rhone-Poulenc<br />

Rorer/Le Nigen<br />

Pharma<br />

oral susp. 3,5g+4g/100ml 250ml Rhone-Poulenc<br />

Rorer/Le Nigen<br />

Pharma<br />

10mg/ml 3ml amp. N3 Schering AG<br />

3210. Mabron Tramadolum sol. for inj. 100mg/2ml N5 Medochemie<br />

3211. Mabron Tramadolum caps. 50mg N10;N20 Medochemie<br />

3212. Mabthera Rituximab Concentrate for<br />

sol. for inf.<br />

3213. Macmiror Nifuratelum sugar coated<br />

tab.<br />

10mg/ml 10ml N2; 50ml N1 Roche<br />

200mg<br />

N20<br />

Poli Industria<br />

Chimica<br />

3214. Macmiror complex 500 Nifuratelum+ Nystatinum cream 10g+ 4000000UA/100g 30g Poli Industria<br />

Chimica<br />

3215. Macmiror complex 500 Nifuratelum+ Nystatinum vaginal supp. 500mg+ 200000UA N12 Poli Industria<br />

Chimica<br />

3216. Macrodex 6 % cum Natrii<br />

chloridum<br />

Dextranum 70+ Natrii<br />

chloridum<br />

3217. Macropen Midecamyci-num gran. for oral<br />

susp.<br />

sol. for inf 60g+9g/l<br />

400ml<br />

N25<br />

Ilsanta<br />

175mg/5ml 115ml KRKA


EN<br />

260 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3218. Macropen Midecamyci-num tab. 400mg<br />

N16<br />

3219. Madopar Levodopum+<br />

Benserazidum<br />

Strength Manufacturer<br />

KRKA<br />

dispersible tab. 100mg+25mg N30; N100 Roche<br />

3220. Madopar Levodopum+ Benserazidum caps. 100mg+ 25mg N100 Roche<br />

3221. Madopar 250 ‘Roche’ Levodopum+Benserazidum tab. 200mg+50mg N30;N100 Roche<br />

3222. Madopar HBS Levodopum+<br />

Benserazidum<br />

3223. Magne B6 Magnesii lactas dihydricus+<br />

Pyridoxini hydrochloridum<br />

3224. Magne B6 Magnesii lactas dihydricus+<br />

Magnesii pidolas + Pyridoxini<br />

hydrochloridum<br />

controlledrelease<br />

caps.<br />

100mg+25mg N100 Roche<br />

coated tab. 470mg+5mg N50 Sanofi Winthrop<br />

oral sol. 186mg+ 936mg+ 10mg/10ml<br />

amp.N10<br />

3225. Magnerot Magnesii orotas tab. 500mg<br />

N50<br />

3226. Magnesium Diasporal 300 Magnesii citras gran. for oral<br />

sol.<br />

1 830mg/5g sachet N20; N50 Protina<br />

3<strong>227</strong>. Magnesium Diasporal 4mmol Magnesii sulfas sol.for inj. 640mg/2ml amp.N5 Protina<br />

Sanofi Winthrop<br />

Worwag Pharma<br />

3228. Magnesium Nycomed Magnesium elemental chewable tab. 120mg (5mmol) Nycomed Pharma<br />

3229. Magnesium Sulphate<br />

Heptahydrate (Epsem's Salt)<br />

Magnesii sulfas subst. 50kg Kirsch Pharma<br />

3230. Magnesium-Diasporal Orange Magnesii citras lozenges 610mg N20;N50;<br />

N100<br />

3231. Magnevist Gadopentetate dimeglumine sol. for inj. 469mg/ml 5ml;10ml; 15ml;<br />

20ml vials<br />

3232. Magnio karbonato 120 mg<br />

tablete˙s<br />

3233. Magnio sulfato 20 % tirpalas<br />

injekcijoms<br />

3234. Magnio sulfato 25 % tirpalas<br />

injekcijoms<br />

3235. Magnio sulfato 25 % tirpalas<br />

injekcijoms<br />

3236. Magnio sulfato 25 % tirpalas<br />

injekcijoms<br />

3237. Magnis ir Vit. B6 Pyridoxini hydrochloridum,<br />

magnesii lactatum dihydratum<br />

Magnii carbonas tab. 120 mg N10; N30; N50; N60;<br />

N100<br />

Protina<br />

Schering<br />

Liuks<br />

Magnesii sulfas sol. for inj. 1g/5ml N10 Bakteriniai<br />

preparatai<br />

Magnesii sulfas sol. for inj. 250mg/ml 5ml amp.<br />

N10<br />

Endokrininiai<br />

preparatai<br />

Magnesii sulfas sol. for inj. 1,25g/5ml N10 Bakteriniai<br />

preparatai<br />

Magnesii sulfas sol. for inj. 250mg/ml amp.10ml N5; N10 Sanitas<br />

3238. Magrilan Fluoxetinum caps., hard 20mg<br />

N30<br />

3239. Magurol 1 mg Doxazosinum tab. 1mg<br />

N20<br />

3240. Magurol 2 mg Doxazosinum tab. 2mg<br />

N20<br />

3241. Magurol 4 mg Doxazosinum tab. 4mg<br />

N20<br />

tab. N50 Liuks<br />

Medochemie<br />

Medochemie<br />

Medochemie<br />

Medochemie


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 261<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3242. Magvit Magnesii lactas+Pyridoxinum gastro-resistant<br />

tab.<br />

3243. Majamil Diclofenacum prolongedrelease<br />

coated<br />

tab.<br />

Strength Manufacturer<br />

470mg+5mg N50 Glaxo Wellcome<br />

100mg<br />

N20<br />

3244. Majamil Diclofenacum coated tab. 50mg<br />

N20<br />

3245. Majamil Diclofenacum coated tab. 25mg<br />

N20<br />

3246. Makrovit Retinolum+Colecalciferolum +<br />

Acidum ascorbicum+<br />

Nicotinamidum+Tocopheroli<br />

acetas +Calcii pantothenas+<br />

Riboflavinum+Thiamini nitras+<br />

Pyridoxini hydrochloridum+<br />

Cyanocobalaminum<br />

3247. Malation 0,5% liniment Malathionum sol. for<br />

cutaneous use<br />

3248. Mandol Cefamandolum powder for sol.<br />

for inj.<br />

coated tab. 1 500 UI +100 UI +80mg+<br />

5mg+5mg+5mg+0,6mg+<br />

0,5mg+1mg+2µg<br />

N30<br />

Polpharma/<br />

Norfachema<br />

Polpharma/<br />

Norfachema<br />

Polpharma/<br />

Norfachema<br />

KRKA<br />

5mg/g 50ml A/S Den norske<br />

Eterfabrikk<br />

1g/vial<br />

N1<br />

Eli Lilly<br />

3249. Maninil 1,75 Glibenclamidum tab. 1,75mg N30; N60; N120 Berlin-Chemie<br />

3250. Maninil 3,5 Glibenclamidum tab. 3,5mg N30; N60; N120 Berlin-Chemie<br />

3251. Maninil 5 Glibenclamidum tab. 5mg N120 Berlin-Chemie<br />

3252. Mannisol A Mannitolum sol. for inf. 100g/1000ml 500ml Human<br />

3253. Mannisol B Mannitolum sol. for inf. 200g/1000ml 100ml; 500ml Human<br />

3254. Mannita 10 % škidums<br />

infuzijam<br />

3255. Mannita 15 % škidums<br />

infuzijam<br />

3256. Mannita 20 % škidums<br />

infuzijam<br />

3257. Mannitol<br />

10 % 500ml Intravenous<br />

solution<br />

3258. Mannitol<br />

15 % 500ml Intravenous<br />

solution<br />

3259. Mannitol<br />

10 %<br />

3260. Manti me˙tu˛ skonio Aluminii hydroxidum<br />

+Magnesii hydroxidum+<br />

Simeticonum<br />

3261. Maraslavin original Herb.Artemisiae pontici+<br />

Fruct.Piperis nigri+<br />

Flor.Caryophylli+<br />

Rhiz.Zingiberis+Herb.Saturejae<br />

hortensis+ Ammonium<br />

chloridum+Acidum aceticum<br />

Mannitolum sol. for inf. 100g/1000ml 500ml; 1000ml<br />

plastic bag 250ml; 500ml<br />

‘Propyflex’<br />

Mannitolum sol. for inf. 150g/1000ml 500ml; 1000ml<br />

250ml; 500ml ‘Propyflex’<br />

Grindex<br />

Grindex<br />

Mannitolum sol.for inf. 200g/1000ml 250ml; 500ml Grindeks<br />

Mannitolum sol. for inj.i.v. 100g/1000ml 500ml Ilsanta<br />

Mannitolum sol. for inj.i.v. 150g/1000ml 500ml Ilsanta<br />

Mannitolum sol. for inf 100g/l buteliuke 500ml Balkanpharma-<br />

Troyan<br />

schewable tab. 200mg+<br />

200mg+<br />

25mg<br />

N10; N30<br />

mixt. 2,4g+0,5g+2g+2,4g+0,4g+<br />

2,5g+16g /100g 100ml<br />

US Pharmacia<br />

Lavena


EN<br />

262 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3262. Marcaine Spinal 0,5 % Bupivacainum sol. for inj. 5mg/ml 4ml amp. N5 AstraZe-neca<br />

3263. Marcaine Spinal 0,5 % Heavy Bupivacainum sol. for inj. 5mg/ml 4ml amp. N5 Astra-Zeneca<br />

3264. Margalapio margainio zˇole˙ Herb. Silybi mariani herbal tea N25 po 1,5g; 50g Acorus Calamus<br />

3265. Marvelon Desogestrelum+<br />

Ethinylestradiolum<br />

3266. Mastodynon N Agnus castus D1 +<br />

Caulophylum thalictroides D4+<br />

Cyclamen D4+ Ignatia D6+Iris<br />

D2 +Lilium tigrinum D3<br />

(Ethanolum 53%)<br />

3267. Mastu S Bufexamacum+ Bismuthi<br />

subgallas+<br />

Titanii dioxidum+ Lidocainum<br />

3268. Mastu S forte Bufexamacum+<br />

Bismuthi subgallas+<br />

Titanii dioxidum + Lidocainum<br />

3269. Materna (with Selenium) Betacarotenum+<br />

Retinolum+Tocopherolum+<br />

Acidum ascorbicum+Acidum<br />

folicum+Thiaminum+<br />

Riboflavinum+Nicotinamidum<br />

+Pyridoxinum+<br />

Cyanocobalaminum+<br />

Cholecalciferolum+Biotinum+<br />

Acidum pantothenicum+<br />

Calcium+Magnesium+<br />

Iodum+Ferrum+<br />

Cuprum+Zincum+<br />

Chromium+Manganum+<br />

Molybdenum<br />

tab. 0,15mg+30µg N21; N63;<br />

N126<br />

drops 20g+10g+ 10g+10g+ 20g+<br />

10g/100g 50ml;100ml<br />

ointment 50mg+50mg+ 50mg+5mg/g<br />

20g<br />

supp. 250mg+100mg+100mg+<br />

10mg N10<br />

film-coated tab. 1 500 UI+1 500 UI+<br />

30UI + 100mg+1mg+ 3mg+<br />

3,4mg+20mg +10mg+ 12µg+<br />

250IU +30µg+10mg+250mg +<br />

50mg+ 150µg+60mg +2mg+<br />

25mg+25µg+<br />

5mg+25mg N30; N100<br />

3270. Maurers Melissengeist Melissen-Destillat+Melissenol tinc. 3g+5g/ 1000ml (alcohol 43%)<br />

500ml<br />

3271. Maxalt Rizatriptanum tab. 10mg N2; N6 MSD<br />

3272. Maxalt Rizatriptanum tab. 5mg N2; N6 MSD<br />

3273. Maxalt RPD Rizatriptanum efferv. tab. 5mg N2; N6 MSD<br />

3274. Maxalt RPD Rizatriptanum efferv. tab. 10mg N2; N6 MSD<br />

3275. Maxidex Dexamethasonum eye ointment 1mg/g<br />

3,5g<br />

3276. Maxidex Dexamethasonum eye drops,susp 1mg/ml<br />

5ml<br />

3277. Maxipime Cefepimum powder for sol.<br />

for inj.<br />

3278. Maxipime Cefepimum powder for sol.<br />

for inj.<br />

3279. Maxipime Cefepimum powder for sol.<br />

for inj.<br />

3280. Maxitrol Dexamethasonum+<br />

Neomycinum+<br />

Polymyxinum B<br />

500mg<br />

N1<br />

2000mg<br />

N1<br />

1000mg<br />

N1<br />

Organon<br />

Bionorica<br />

Stada<br />

Stada<br />

Wyeth-Ayerst/<br />

Wyeth-Lederle<br />

Sebastian Stroh<br />

Alcon-Couvreur<br />

Alcon-Couvreur<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

eye drops, susp. 1mg+3500IU+6000IU/ml 5ml Alcon-Couvreur


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 263<br />

No. Commercial name General name<br />

3281. Maxitrol Dexamethasonum+<br />

Neomycinum+ Polymyxinum<br />

B<br />

Pharmaceutical<br />

form<br />

3282. Medaxone Ceftriaxonum powder for<br />

solution for<br />

injection<br />

3283. Medetkos tepalas Tinct. Calendulae ointment 100mg/g<br />

20g; 40g<br />

Strength Manufacturer<br />

eye ointment 1mg+3500IU+6000IU/g 3,5g Alcon-Couvreur<br />

1000mg/vial N10 Medochemie Ltd.<br />

3284. Medetkos tinktūra Calendulae flores tinct. 100g (Ethanolum 70% ad 1l)<br />

40ml<br />

3285. Medetkos tinktūra Flor. Calendulae + Ethanolum<br />

70%<br />

Sanitas<br />

Vilniaus f.f.<br />

tinct. 100g +ad 1l 40ml Sanitas<br />

3286. Medetkos zˇiedynai Flor. Calendulae 50g; 2g×25;16,8g (0,7g×24);<br />

24g(1g×24); 36g(1,5g×24);<br />

48(2g×24)<br />

3287. Medetku˛ tinktūra Calendulae flores tinct. 100g/1 000ml (Ethanolum<br />

70 % (V/V) ad praeparationibus<br />

1l ticturae) 40ml; 50ml<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Bakteriniai<br />

preparatai<br />

3288. Mediab 5 mg Glipizidum tab. 5mg N30 Medicom<br />

3289. Medicininis azoto suboksidas Nitrogenium oxydulatum inhalation gas 98% 10l-7kg; 20l-13kg AGA GAS<br />

3290. Medicininis azoto suboksidas Nitrogenium oxydulatum inhalation gas 96% 6 kg Stirol<br />

3291. Medicininis deguonis (dujinis) Oxygenium gas 99,7% i˛vairiu˛ dydzˇiu˛ spec.talpos<br />

Nuklono energetika/<br />

Trolis<br />

3292. Medicininis deguonis (skystas) Oxygenium 99,7% 5l;10l;20l;40l Nuklono energetika/<br />

Trolis<br />

3293. Medinite Doxylamini succinas+<br />

Pseudoephedrini<br />

hydrochloridum+<br />

Dextromethorphani<br />

hydrobromidum+<br />

Paracetamolum<br />

3294. Medipont 2 % Adrenaline<br />

1:10 000<br />

sir. 7,5mg+60mg+15mg+<br />

600mg/30ml (Ethanolum<br />

18 vol.-%) 180ml<br />

Mepivacainum+ Epinephrinum sol. for inj. 20mg+ 10µg/ml 1,8ml<br />

cart-ridge N50<br />

Procter & Gamble<br />

Molteni<br />

3295. Medipont 3 % Mepivacainum sol. for inj. 30mg/ml 1,8ml cartridges N50 Molteni<br />

3296. Medipyrin Paracetamolum tab. 500mg<br />

N10<br />

3297. Medoclav Amoxicillinum+ Acidum<br />

clavulanicum<br />

3298. Medoclav 375 Amoxicillinum+<br />

Acidum clavulanicum<br />

3299. Medoclav 625 Amoxicillinum+<br />

Acidum clavulanicum<br />

3300. Medoclav forte Amoxicillinum+ Acidum<br />

clavulanicum<br />

powder for oral<br />

susp.<br />

film-coated tab. 250mg+<br />

125mg<br />

N20<br />

film-coated tab. 500mg+<br />

125mg<br />

N20<br />

powder for oral<br />

susp.<br />

125mg+ 31,25mg/ 5ml 60ml;<br />

100ml<br />

250mg+ 62,5mg/5ml 60ml;<br />

100ml<br />

Slovakofarma<br />

Medochemie<br />

Medochemie<br />

Medochemie<br />

Medochemie<br />

3301. Medoglycin Lincomycinum sol. for inj. 300mg/ml 1ml amp. N10 Medochemie<br />

3302. Medozine Cinnarizinum tab. 25mg N100 Medochemie


EN<br />

264 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3303. Medrol Methylprednisolonum tab. 4mg N30;N100 Pharmacia & Upjohn<br />

3304. Medrol Methylprednisolonum tab. 16mg<br />

N50<br />

3305. Mefoxin Cefoxitinum powder for sol.<br />

for inj.<br />

3306. Mefoxin Cefoxitinum powder for sol.<br />

for inj.<br />

Pharmacia & Upjohn<br />

2g N1; N10 MSD-Haarlem<br />

1g N1; N10 MSD-Haarlem<br />

3307. Megace Megestrolum tab. 40mg Bristol-Myers Squibb<br />

3308. Megace Megestrolum oral susp. 40mg/ml 120ml; 240ml;<br />

480ml<br />

3309. Megace<br />

160 mg tablets<br />

3310. Megalotect Human cytomegalovirusimmunoglobulin<br />

3311. Megalotect Human cytomegalovirusimmunoglobulin<br />

Megestroli acetas tab. 160mg<br />

N30<br />

sol. for inf. 100mg/ml 10ml; 20ml amp.<br />

N1<br />

3312. Melipramin Imipraminum coated tab. 25mg<br />

N50<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Biotest<br />

sol. for inf. 100mg/ml 50ml bottles N1 Biotest<br />

3313. Melipramin injection Imipramini hydrochloridum sol. for inj. 25mg/2ml amp. N10 Egis<br />

3314. Melisal Extr. fluidum (1:1) ex.: herb.<br />

Melissae, herb.Hyperici, inf.<br />

Crataegi, inf.Tiliae, rad.<br />

Archangekicae,<br />

anth.Chamomillae+<br />

Concentratum fruct. Ribis<br />

rubrum +Aroma fruct. Ribis<br />

rubrum+Saccharum+Aqua<br />

syrup 10 parts+<br />

5 parts+<br />

3,5 parts+<br />

60 parts+<br />

24,5 parts<br />

125g<br />

3315. Melisos ekstraktas Folium Melissae extr. 1000 g Ethanolum ad 1 l<br />

25 ml,<br />

50 ml;100 ml<br />

3316. Melisos tinktūra Melissae folium tinct. 100 g Ethanolum ad 1 l 50ml,<br />

100 ml<br />

Egis<br />

Herbapol Wroclaw<br />

Bakteriniai<br />

preparatai<br />

Bakteriniai<br />

preparatai<br />

3317. Melissa fix Melissae officinalis folium herbal tea 2g/maišelyje N20 Herba Humana<br />

3318. Melis-Tonic Alcoholic tinct. (1:5) ex:<br />

Fol.Melissae+ Flor.Crataegi+<br />

Flor.Chamomillae+<br />

Rad.Archangelicae+Fruct.Carvi<br />

3319. Melleril Thioridazinum film-coated tab. 10mg<br />

N30<br />

tinct. 40g+35g+ 10g+10g+ 5g 35g;<br />

100g<br />

3320. Melleril Thioridazinum film-coated tab. 100mg<br />

N30<br />

Herbapol Cracow<br />

Novartis Pharma<br />

Novartis Pharma<br />

3321. Melox Meloxicamum tablets 7,5mg N30 Medochemie Ltd.<br />

3322. Melox Meloxicamum tablets 15mg N20 Medochemie Ltd.<br />

3323. Me˙lyne˙s ūgliai Cormus Myrtilli herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

3324. Me˙lyne˙s vaisiai Fruct.Myrtilli herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 265<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3325. Me˙lyniu˛ ūgliai Cormus Myrtilli subst. 25kg Švenčioniu˛<br />

vaistazˇole˙s<br />

3326. Memoplant Extr.fol.Ginkgo bilobae (35-<br />

65:1)<br />

3327. Menalgin Magnesium phosphoricum<br />

D2+Chamomilla D2+<br />

Colocynthis D3+Potentilla<br />

anserina O+ Aesculus D1<br />

film-coated tab. 40mg<br />

N30<br />

3328. Mencevax ACWY compos. powder and<br />

solvent for<br />

solution for<br />

injection<br />

3329. Meningoco-ccal polysaccharide<br />

vaccine A+C<br />

Polysaccharide of: Neisseria<br />

meningitidis group A+<br />

Neisseria meningitidis group C<br />

3330. Menopace Retinolum+ Colecalciferolum+<br />

Tocopherolum+ Thiaminum+<br />

Riboflavinum+ Pyridoxinum+<br />

Cyanocobalaminum+ Acidum<br />

folicum+ Biotinum+<br />

Nicotinamidum+ Acidum<br />

ascorbicum+ Calcii<br />

pantothenas+ Acidum aminobenzoicum+<br />

Ferrum+Zinc+<br />

Magnesium+ Manganum+<br />

Iodum+Cuprum+ Chromium+<br />

Selenium+Borum<br />

tab. 25mg+ 25mg+ 25mg+<br />

100mg+ 25mg N80;N100;<br />

N200<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

3331. Menorest 37,5 Estradiolum transdermal<br />

patch<br />

3332. Menorest 50 Estradiolum transdermal<br />

patch<br />

3333. Menorest 75 Estradiolum transdermal<br />

patch<br />

3334. Menovazinas Mentholum+ Procainum+<br />

Benzocainum<br />

3335. Menpolio purškalas Mentholum racemicum +<br />

Procaini hydr. + Benzocaini<br />

3336. Menpolis Mentholum racemicum+<br />

Procainum+ Benzocainum+<br />

Ethanolum 70%<br />

50mcg/vial +solvent amp. N1;<br />

N100<br />

50µg+ 50µg/vial N1 (vial with<br />

powder and syringe with<br />

solvent 0,5ml)<br />

caps. 2500IU(750µg)+100IU<br />

(2,5µg)+ 30mg+ 10mg+5mg+<br />

40mg+9µg+400µg+ 30µg+<br />

20mg+ 45mg+ 30mg+ 38mg+<br />

15mg+ 100mg+ 2mg+225µg+<br />

1mg+50µg+100µg+ 2mg N30<br />

37,5µg/day (3,28mg/ 11cm 2 )<br />

N8<br />

50µg/day (4,33mg/ 14,5cm 2 )<br />

N8<br />

Dr.Willmar Schwabe<br />

DHU<br />

GlaxoSmithKline<br />

Biologicals s.a.<br />

Pasteur Merieux<br />

Serums & Vaccins<br />

Vitabiotics<br />

Rhone-Poulenc<br />

Rorer<br />

Rhone-Poulenc<br />

Rorer<br />

75µg/day (6,57mg/ 22cm 2 ) N8 Rhone-Poulenc<br />

Rorer<br />

sol. 2,5g+1g+ 1g Ethanolum 70%<br />

ad 100 ml 40ml<br />

aer. 2,5+1 + 1 Ethanolum ad<br />

100 ml<br />

liq. 25mg+10mg+10mg+ad 1ml<br />

40ml; 50ml<br />

Vilniaus f.f.<br />

Bakteriniai<br />

preparatai<br />

Bakteriniai<br />

preparatai<br />

3337. Mensoton 200 Ibuprofenum film-coated tab. 200mg N20 Berlin-Chemie<br />

(Menarini Group)<br />

3338. Mentax Butenafinum cream 10mg/g 10g Kaken<br />

Pharmaceutical<br />

3339. Mentha fix Menthae piperitae folium herbal tea 2g/sachet N20 Herba Humana<br />

3340. Mentholatum Balm Mentholum+ Camphora+<br />

Methylis salicylas<br />

cream 1,35%+9%+0,33% 4g;30g Mentholatum<br />

3341. Mephaquin Mefloquinum lactab 250mg N4;N6 Mepha Ltd.


EN<br />

266 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

3342. Mercilon Desogestrelum+<br />

Ethinylestradiolum<br />

3343. Mercurius-Heel S Mercurius solubilis<br />

Hahnemanni D10+Hepar<br />

sulfuris D8+ Lachesis mutus<br />

D12+ Phytolacca americana<br />

D4+ Ailanthus altissima D3+<br />

Echinacea angustifolia D3+<br />

Atropa belladonna D4<br />

3344. Meronem IV<br />

1g<br />

Pharmaceutical<br />

form<br />

Meropenemum powder for sol.<br />

for inj.<br />

3345. Meronem IV 500 mg Meropenemum powder for<br />

solution for<br />

injection<br />

3346. Merz Spezial Dragees Betacarotenum+ Retinolum+<br />

Cholecalciferolum+<br />

Tocoferolum+Thiaminum+<br />

Riboflavinum+Pyridoxinum+<br />

Cyanocobalaminum+<br />

Nicotinamidum+Calcii<br />

pantothenas+Biotinum+<br />

Acidum ascorbicum+<br />

Cysteinum+Ferrosi fumaras+<br />

Faecis extractum<br />

Strength Manufacturer<br />

tab. 150µg+20µg N21; N63; N126 Organon<br />

tab. 90mg+ 30mg+ 30mg+ 30mg+<br />

30mg+ 30mg+ 60mg N50;<br />

N250<br />

1g/vial<br />

N10<br />

500mg/vial<br />

N10<br />

drag. 0,9mg+ 1500 IU+ 50IU +<br />

9mg+1,2mg+1,6mg+ 1,2mg+<br />

2µg+10mg+ 3mg+10µg+<br />

75mg+30mg+ 20mg+100mg<br />

3347. Mesatonum sol. 1% 1ml Phenylephrinum sol. 1% 1ml N10 Liuks<br />

Heel<br />

Sumito/ Astra-<br />

Zeneca<br />

Sumito/ Astra-<br />

Zeneca<br />

Merz+Co<br />

3348. Meškauoge˙s lapai Fol. Urvea ursi herbal tea 50g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

3349. Mesporin — 1000 I.M. Ceftriaxonum powder and<br />

solvent for sol.<br />

for inj.<br />

3350. Mesporin — 1000 I.V. Ceftriaxonum powder and<br />

solvent for sol.<br />

for inj.<br />

3351. Mesporin — 2000 I.V. Ceftriaxonum powder for sol.<br />

for inj.<br />

3352. Mesporin — 250 I.M. Ceftriaxonum powder and<br />

solvent for sol.<br />

for inj.<br />

3353. Mesporin — 500 I.M. Ceftriaxonum powder and<br />

solvent for sol.<br />

for inj.<br />

1000mg/vial and solv.<br />

( Lidocaini hydrochloridum<br />

35mg /3,5ml) amp. N1<br />

Mepha<br />

1000mg/ vial N1 Mepha<br />

2000mg / vial N1 Mepha<br />

250mg/vial and solv.<br />

(Lidocaini hydrochlodum<br />

20mg/2ml) amp. N1<br />

500mg/ vial and solv.<br />

(Lidocaini hydrochloridum<br />

20mg/ 2ml) amp. N1<br />

3354. Mesulid Nimesulidum granules 100mg<br />

N15, N30, N60<br />

3355. Mesulid Nimesulidum supp. 200mg<br />

N10<br />

3356. Mesulid Nimesulidum tab. 100mg<br />

N10, N30, N60<br />

Mepha<br />

Mepha<br />

Helsinn<br />

Rhone-Poulenc<br />

Rorer/<br />

Helsinn<br />

Helsinn<br />

3357. Mesulid 1 % Nimesulidum oral susp. 1g/100ml 200ml Schering-Plough<br />

3358. Metadon DAK Methadonum mixt. 1mg/ml 5ml; 10ml; 25ml;<br />

40ml; 50ml; 80ml; 100ml;<br />

300ml; 1000ml<br />

Nycomed Pharma


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 267<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3359. Metadon Nycomed Methadonum tab. 20mg<br />

N25; N100<br />

Strength Manufacturer<br />

Nycomed Danmark<br />

3360. Metadon Nycomed Methadonum tab. 5mg N5; N10; N20; N100 Nycomed Danmark<br />

3361. Metadoxil Metadoxinum sol. for inj. 300mg/5ml N10 Baldacci<br />

3362. Metadoxil Metadoxinum tab. 500mg N30 Baldacci<br />

3363. Metamol Metoclopramidum tab. 10mg N30;1000 CTS<br />

3364. Metastron Strontium [89Sr] chloride sol. for inj. 37MBq/ml 4ml vial N1 Nycomed Amersham<br />

3365. Meteospas-myl Alverinum+ Simeticonum caps. 60mg+ 300mg N20 Mayoly Spindler<br />

3366. Metfogamma 500 Metforminum film-coated<br />

tablets<br />

3367. Metfogamma 850 Metforminum film-coated<br />

tablets<br />

500mg N30;N120 Drageno-pharm<br />

850mg N30;N120 Artesan Pharma<br />

GmbH<br />

3368. Metforal 500 Metforminum film-coated tab. 500mg N30; N60; N120 Berlin-Chemie<br />

3369. Metforal 850 Metforminum film-coated tab. 850mg N30; N60; N120 Berlin-Chemie<br />

3370. Metformin Metforminum tablets 500mg N30 Galena<br />

Pharmaceutical<br />

Manufacturing<br />

Cooperative<br />

3371. Metformin — ratiopharm<br />

500 mg<br />

3372. Metformin — ratiopharm<br />

850 mg<br />

Metforminum film-coated tab. 500mg<br />

N30<br />

Metforminum film-coated tab. 850mg<br />

N30; N120<br />

3373. Metformin 500 Lečiva Metforminum film-coated tab. 500mg<br />

N100<br />

Merckle<br />

Merckle<br />

3374. Metformin 850 Metformnum tablets 850mg N30 Galena<br />

Pharmaceutical<br />

Manufacturing<br />

Cooperative<br />

3375. Metformin 850 Metformin tab. 850 mg N30 Liuks<br />

3376. Metformin 850 Lečiva Metforminum film-coated tab. 850mg<br />

N50; N100<br />

3377. Metformin Alpharma Tablets<br />

500 mg<br />

3378. Metformin Alpharma Tablets<br />

850 mg<br />

Lečiva<br />

Lečiva<br />

Metforminum film-coated tab. 500mg N28; N30; N100 Alpharma<br />

Metforminum film-coated tab. 850mg N50; N56 Alpharma<br />

3379. Metformin BMS Metforminum tab. 500mg N30; N100; N500 GEA<br />

3380. Metformin Galena Metformin tab. 500 mg N30 Liuks<br />

3381. Methadone Methadonum inj. 10mg/ml N10 1ml Icelandic<br />

Pharmaceuticals<br />

3382. Methadoni hydrochloridum Ph.<br />

Eu.<br />

Methadonum subst. Bufa<br />

3383. Methotrexat ‘Ebewe’ Methotrexatum concentrate for<br />

sol. for inf.<br />

1 000mg/10ml vial N1 Ebewe


EN<br />

268 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

3384. Methotrexat ‘Ebewe’<br />

10 mg/ml<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

Methotrexatum sol. for inj./inf. 10mg/ml 1ml vial N1 Ebewe Pharma<br />

3385. Methotrexat ‘Ebewe’ 5 mg Methotrexatum tab. 5mg<br />

N50<br />

3386. Methotrexat ‘Ebewe’<br />

50 mg<br />

3387. Methotrexat ‘Ebewe’<br />

500 mg<br />

3388. Methotrexat ‘Ebewe’<br />

50 mg/5 ml<br />

Methotrexatum sol.for inj. or<br />

inf.<br />

Methotrexatum concentrate for<br />

sol. for inf.<br />

Methotrexatum sol. for inj./inf. 10mg/ml<br />

5ml vial N1<br />

3389. Methotrexat ‘Ebewe’ 2,5mg Methotrexatum tab. 2,5mg<br />

N50<br />

3390. Methotrexat Lachema 1000<br />

inj.<br />

50mg/5ml vial N1 Ebewe<br />

500mg/5ml vial N1 Ebewe<br />

Ebewe Pharma<br />

Ebewe Pharma<br />

Ebewe Pharma<br />

Methotrexatum sol. for inj. 1000mg/ 20ml vials N1; N10 Lachema<br />

3391. Methotrexat Lachema 20 inj. Methotrexatum sol. for inj. 20mg/2ml vials N1; N10 Lachema<br />

3392. Methotrexat Lachema 5 inj. Methotrexatum sol. for inj. 5mg/2ml vials N1; N10 Lachema<br />

3393. Methotrexat Lachema 5 inj.<br />

sicc.<br />

Methotrexatum powder for sol.<br />

for inj.<br />

5mg/vial N1; N10 Lachema<br />

3394. Methotrexat Lachema 50 inj. Methotrexatum sol. for inj. 50mg/5ml vials N1; N10 Lachema<br />

3395. Methotrexat Lachema 50 inj.<br />

sicc.<br />

Methotrexatum powder for sol.<br />

for inj.<br />

3396. Methotrexate Methotrexatum tab. 2,5mg<br />

N20<br />

50mg/vial N1; N10 Lachema<br />

3397. Methotrexate Methotrexatum sol. for inj. 25mg/ml 2ml N5 Abic<br />

3398. Methotrexate Methotrexatum sol. for inj. 2,5mg/ml 2ml N5 Abic<br />

Rhone-Poulenc<br />

Rorer<br />

3399. Methotrexate Methotrexatum sol. for inj. 100mg/ml 10ml N1 Abic for Teva<br />

3400. Methotrexate Methotrexatum sol. for inj. 25mg/ml<br />

2ml vials N5<br />

3401. Methotrexate Methotrexatum sol. for inj. 25mg/ml<br />

20ml vials N1<br />

3402. Methylpredni<br />

solon Sopharma<br />

40 mg<br />

3403. Methylprednisolon Sopharma<br />

125 mg<br />

3404. Methylprednisolon Sopharma<br />

250 mg<br />

Methylprednisolonum powder for sol.<br />

for inj.<br />

Methylprednisolonum powder for sol.<br />

for inj.<br />

Methylprednisolonum powder for sol.<br />

for inj.<br />

40mg/amp.+<br />

1ml amp. of solvent N5<br />

125mg/amp.+<br />

2ml amp. of solvent N5<br />

250mg/amp.+<br />

5ml amp. of solvent N5<br />

3405. Methyluracilum 0,5g supp. Methyluracilum supp. 0,5g N10 Liuks<br />

3406. Methyluracilum ung. 10% Methyluracilum ointment 10% 25g Liuks<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Sopharma PLC<br />

Sopharma PLC<br />

Sopharma PLC<br />

3407. Metindol Indometacinum sol. for inj. 60mg/2ml amp.N10 Pliva Krakow<br />

3408. Metindol Indometacinum coated tab. 25mg<br />

N30<br />

Polfa Warsaw<br />

3409. Metindol Indometacinum ointment 50mg/g 30g Glaxo Wellcome


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 269<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3410. Metindol Retard Indometacinum tab. 75mg N25;N50 ICN Polfa Rzeszow<br />

3411. Metizol Thiamazolum tab. 5mg N50 ICN Polfa Rzeszow<br />

3412. Metoclopramid Metoclopramidum sol. for inj. 10mg/2ml<br />

N5<br />

3413. Metoclopramid Metoclopramidum tab. 10mg<br />

N50<br />

3414. Metoclopramide Alpharma<br />

Tablets 10 mg<br />

Polpharma<br />

Polpharma<br />

Metoclopramidum tab. 10mg N20 Alpharma<br />

3415. Metoklopramidas 10 mg Metoclopramidum sol.for inj. 10mg/2ml amp. N10; N100 Pharmamed/ Ilsanta<br />

3416. Metoklopramido 10 mg<br />

tablete˙s<br />

3417. Metoklopramido 10 mg<br />

tablete˙s<br />

Metoclopramidum tab. 10 mg N20; N50 Liuks<br />

Metoclopramidum tab. 10mg N20; N50 Bakteriniai<br />

preparatai<br />

3418. Metoloc Z 50 Metoprololum retard tablets 50mg N30 Salutas Pharma<br />

GmbH<br />

3419. Metoprolol Metoprololum tab. 50mg N30;N40 ICN Polfa Rzeszow<br />

3420. Metoprolol 100 Stada Metoprololum tab. 100mg N20; N50; N100 Stada<br />

3421. Metoprolol 200 Stada retard Metoprololum modified-release<br />

tab.<br />

200mg N50;N100 Stada<br />

3422. Metoprolol 50 Stada Metoprololum tab. 50mg N20; N50; N100 Stada<br />

3423. Metoprolol-EGIS 25 mg Metoprololum tab. 25mg N60; N200 Egis<br />

3424. Metoprolol-EGIS 100 mg Metoprololum tab. 100mg N60; N200 Egis<br />

3425. Metoprolol-EGIS 50 mg Metoprololum tab. 50mg N60; N200 Egis<br />

3426. Metoprolol-ratiopharm 100 Metoprololum tab. 100mg N30 Merckle<br />

3427. Metoprolol-ratiopharm 50 Metoprololum tab. 50mg N30 Merckle<br />

3428. Metrodin HP Urofollitropinum powder and<br />

solvent for sol.<br />

for inj.<br />

3429. Metrodin HP Urofollitropinum powder and<br />

solvent for sol.<br />

for inj.<br />

3430. Metrogyl Metronidazolum solution for<br />

infusions/<br />

injection<br />

3431. Metrogyl Denta Metronidazolum+<br />

Chlorhexidinum<br />

3432. Metrogyl-V gel Metronidazolum vaginal gel<br />

(with<br />

applicator)<br />

3433. Metronidazol 0,5 % Metronidazolum sol. for inf. and<br />

inj.<br />

150IU amp. Serono<br />

75IU amp. Serono<br />

5mg/ml 100ml N1; 20ml N5 Unique<br />

Pharmaceutical<br />

Laboratories<br />

gel 10mg+ 2,5mg/g 50g Unique<br />

Pharmaceutical<br />

Laboratories<br />

10mg/g 30g Unique<br />

Pharmaceutical<br />

Laboratories<br />

5mg/ml 20ml polyethylene<br />

amp.N5; 20ml glass amp.N10;<br />

100ml polyethylene container<br />

N1<br />

Polpharma


EN<br />

270 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3434. Metronidazolas 200 mg Metronidazolum tab. 200mg<br />

N20<br />

3435. Metronidazolas 250 mg Metronidazolum tab. 250mg<br />

N10<br />

Strength Manufacturer<br />

3436. Metronidazole Metronidazolum sol. for inf. 5g/l 100ml Ilsanta<br />

3437. Metronidazolio<br />

200 mg tablete˙s<br />

3438. Metronidazolio 250 mg<br />

tablete˙s<br />

Metronidazolum tab. 200mg<br />

N10; N20<br />

Liuks<br />

Liuks<br />

Endokrininiai<br />

preparatai<br />

Metronidazolum tab. 250mg N20 Endokrininiai<br />

preparatai<br />

3439. Metronidazols 0,5 % Metronidazolum sol. for inf. 500mg/100ml 100ml; 250ml;<br />

500ml<br />

3440. Me˙tu˛ tinktūra Folia Menthae piperitae+<br />

Oleum Menthae piperitae<br />

3441. Me˙tu˛ tinktūra (1:20) BP Menthae piperitae folium+<br />

Menthae piperitae aetheroleum<br />

tinct. 50g+50g (Ethanolum<br />

90% ad 1l) 25ml<br />

tinct. 50g+50g (Ethanolum<br />

90 % ad 1l) 25ml; 50ml<br />

3442. Metypred Methylprednisolonum tab. 4mg N30; N100 Orion<br />

3443. Metypred Methylprednisolonum powder and<br />

solvent for sol.<br />

for inj./inf.<br />

Grindex<br />

Vilniaus f.f.<br />

Bakteriniai<br />

preparatai<br />

250mg/vial + 4ml solvent N1 Orion<br />

3444. Mevacor Lovastatinum tab. 40mg N28 MSD<br />

3445. Mevacor Lovastatinum tab. 20mg N28 MSD<br />

3446. Mezym forte<br />

10 000<br />

Lipasum+Amylasum+<br />

Proteasum<br />

3447. Mezym forte 20 000 Lipasum+ Amylasum+<br />

Proteasum<br />

3448. Mezym forte 3 500 Lipasum+Amylasum +<br />

Proteasum<br />

gastro-resistant<br />

film-coated tab.<br />

gastro-resistant<br />

film-coated tab.<br />

10000U+ 7500U+ 375U<br />

N10; N20; N50; N100<br />

3449. Miacalcic Calcitoninum nasal spray 200 IU/dose<br />

14 doses<br />

20000U+ 12000U+ 900U<br />

N50; N100; N200<br />

Berlin-Chemie<br />

Berlin-Chemie<br />

film-coated tab. 3500U+4200U+250U N20 Berlin-Chemie<br />

3450. Micardis 40 mg Telmisartanum tab. 40mg N14; N28; N56; N98;<br />

N280<br />

Novartis Pharma<br />

Boehringer<br />

Ingelheim<br />

3451. Micardis 80 mg Telmisartanum tab. 80mg N14; N28; N56; N280 Boehringer<br />

Ingelheim<br />

3452. Micardis 20 mg Telmisartanum tab. 20mg N14; N28; N56; N98 Boehringer<br />

Ingelheim<br />

3453. Micardis Plus Telmisartanum+<br />

Hydrochlorothiazidum<br />

3454. Micardis Plus Telmisartanum+<br />

Hydrochlorothiazidum<br />

3455. Miconal Ecobi Miconazolum mono-use<br />

vaginal lavage<br />

tablets 40mg+12,5mg N14;N28;N56;<br />

N98<br />

tablets 80mg+12,5mg N14;N28;N56;<br />

N98<br />

200mg/100ml 150ml N5 Ecobi<br />

3456. Miconal Ecobi Miconazolum vaginal caps. 1200mg N2 Ecobi<br />

3457. Miconal Ecobi Miconazolum cream 2g/100g 30g Ecobi<br />

Boehringer<br />

Ingelheim Pharma<br />

KG<br />

Boehringer<br />

Ingelheim Pharma<br />

KG


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 271<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3458. Miconal Ecobi Miconazolum cream 2g/100g 78g Ecobi<br />

3459. Microgynon Levonorgestrelum+<br />

Ethinylestradiolum<br />

3460. Microlax Natrii laurylsulfoacetas+<br />

Sorbitolum+<br />

Natrii citras<br />

sugar-coated<br />

tab.<br />

0,15mg+ 0,03mg<br />

N21; N28<br />

enema, sol. 9mg+625mg+<br />

90mg/ml 5ml N4; N12<br />

Schering<br />

Pharmacia & Upjohn<br />

3461. Microser Betahistinum tablets 8mg N50 Farmaceutici<br />

Formenti S.r.l.<br />

3462. Microser Betahistinum solution, drops 1,25% 30ml Farmaceutici<br />

Formenti S.r.l /<br />

Grunenthal GmbH<br />

3463. Mifegyne Mifepristonum tablets 200mg N3 Macors Laboratories<br />

3464. Miflonide 200 mcg Budesonidum inhalation<br />

powder, hard<br />

caps.<br />

3465. Miflonide 400 mcg Budesonidum inhalation<br />

powder, hard<br />

caps.<br />

3466. Migpriv Lysini acetylsalicylas (Acidum<br />

acetylsalicylicum)+<br />

Metoclopramidum<br />

3467. Migrenium Extr.Chrysanthemum<br />

parthenium<br />

powder for oral<br />

sol.<br />

caps. 50mg<br />

N30<br />

3468. Mikogal Omoconazolum vaginal supp. 150mg<br />

N6<br />

3469. Mikogal Omoconazolum vaginal supp. 300mg<br />

N3<br />

3470. Mikogal Omoconazolum vaginal supp. 900mg<br />

N1<br />

3471. Mikogal Omoconazolum nitricum<br />

micronizatum<br />

3472. Mikogal Omoconazolum nitricum<br />

micronizatum<br />

3473. Mikro-30 Levonorgestrelum film-coated<br />

tablets<br />

200µg N60 + Aerolizer Novartis<br />

Pharmaceuticals<br />

400µg N60 + Aerolizer Novartis<br />

Pharmaceuticals<br />

1 620mg (900mg)+<br />

10mg/sachet N6<br />

Synthelabo<br />

Biogal<br />

Biogal<br />

Biogal<br />

Biogal<br />

solution 1% 30ml N3 Biogal<br />

Pharmaceutical<br />

Works Ltd.<br />

cream 1% 20g Biogal<br />

Pharmaceutical<br />

Works Ltd.<br />

0,03mg N1×35;N3×35 Wyeth Medica<br />

Ireland /Haupt<br />

Pharma Muenster<br />

3474. Mildronats Mildronatum caps. 250mg N40 Grindex<br />

3475. Mildronats 10 % škidums<br />

injekcijam<br />

3476. Milgamma N Benfotiaminum+<br />

Pyridoxinum+<br />

Cyanocobalaminum<br />

3477. Milgamma N Thiaminum+<br />

Pyridoxinum+<br />

Cyanocobalaminum<br />

Mildronatum sol. for inj. 500mg/5ml N10 Grindex<br />

3478. Miltex Miltefosinum solution for<br />

topical use<br />

caps. 40mg+90mg+ 250µg<br />

N50<br />

inj. 100mg+100mg+1mg/2ml<br />

N5<br />

Worwag Pharma<br />

Worwag Pharma<br />

600mg/10ml bottle N1 Asta Medica


EN<br />

272 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3479. Milurit Allopurinolum tab. 100mg N50 Egis<br />

3480. Milurit Allopurinolum tab. 300mg N30 Egis<br />

3481. Minesse Ethinylestradiolum+<br />

Gestodenum<br />

film-coated tab. 0,015mg+ 0,06mg N28;N84 Wyeth Medica<br />

3482. Minidiab Glipizidum tab. 5mg N30 Pharmacia<br />

3483. Minirin Desmopressinum tab. 0,1mg N30 Ferring<br />

3484. Minirin Desmopressinum tab. 0,2mg N30 Ferring<br />

3485. Minirin Desmopressinum nasal spray 0,1mg/ml (10µg/dose) 2,5ml;<br />

5ml<br />

3486. Minisiston Ethinylestradiolum+<br />

Levonorgestrelum<br />

3487. Minulet Gestodenum+<br />

Ethinylestradiolum<br />

3488. Mirapexin Pramipexolum<br />

dihydrochloridum<br />

monohydricum<br />

3489. Mirapexin Pramipexolum<br />

dihydrochloridum<br />

monohydricum<br />

3490. Mirapexin Pramipexolum<br />

dihydrochloridum<br />

monohydricum<br />

3491. Mirelle Gestodenum+<br />

Ethinylestradiolum<br />

sugar-coated<br />

tab.<br />

3492. Mirena Levonorgestrelum intrauterine<br />

system<br />

0,03mg+<br />

0,125mg<br />

N21<br />

Ferring<br />

Jenapharm<br />

tab. 75µg+30µg N21; N63; N126 Wyeth-Pharma<br />

tab. 0,125mg<br />

N30<br />

tab. 0,25mg<br />

N30<br />

tab. 1mg<br />

N30<br />

film-coated tab. yellow tab.:60µg+ 15µg; white<br />

tab. N28 (24+4)<br />

52mg N1 Leiras<br />

3493. Miros tinktūra Myrrhae tinct. 200 g (Ethanolum ad 11)<br />

50 ml;<br />

100 ml<br />

3494. Miškine˙s sidabrazˇole˙s<br />

šakniastiebiai<br />

3495. Miškine˙s sidabrazˇole˙s<br />

šakniastiebiai (smulkinti)<br />

Boehringer<br />

Ingelheim/<br />

Pharmacia & Upjohn<br />

Boehringer<br />

Ingelheim/<br />

Pharmacia & Upjohn<br />

Boehringer<br />

Ingelheim/<br />

Pharmacia & Upjohn<br />

Wyeth<br />

Pharmaceuticals/<br />

Wyeth Medica<br />

Ireland/ Schering AG<br />

(PCI Allpack)<br />

Bakteriniai<br />

preparatai<br />

Rhiz. Tormentillae herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

Rhizomata Tormentillae herbal tea 50g; 50g (2g×25); 16,8g<br />

(0,7g×24); 24g (1g×24); 36g<br />

(1,5g×24); 48g (2g×24)<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

3496. Mistabron Mesnum inhalation liq. 0,2g/ml 3ml N6 UCB Pharma<br />

3497. Mitoxantron AWD Mitoxantronum sol. for inj. 25mg/12,5ml N1 AWD<br />

3498. Mitoxantron AWD Mitoxantronum sol. for inj. 30mg/15ml<br />

N1<br />

3499. Mivacron Mivacurii chloridum sol. for inj. 2mg/ml 5ml;10ml;25ml Glaxo Wellcome<br />

3500. Mixtard 10 HM Penfill Insulinum humanum susp. for inj. 100IU(3,5mg)/ml cartridge<br />

3ml N5<br />

3501. Mixtard 20 HM Penfill Insulinum humanum susp. for inj. 100IU(3,5mg)/ml cartridge<br />

3ml N5<br />

AWD<br />

Novo Nordisk<br />

Novo Nordisk


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 273<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3502. Mixtard 30 HM Penfill Insulinum humanum susp. for inj. 100IU(3,5mg)/ml cartrige 3ml<br />

N5<br />

3503. Mixtard 30 HM Penfill Insulinum humanum susp. for inj. 100IU(3,5mg)/ml cartridge<br />

1,5ml<br />

3504. Mixtard 30 InnoLet Insulinum humanum<br />

recombinatum (Insulini injectio<br />

biphasica)<br />

susp. for inj. 100UI/ml pre-filled syringe<br />

3ml N5<br />

Strength Manufacturer<br />

Novo Nordisk<br />

Novo Nordisk<br />

Novo Nordisk<br />

3505. Mixtard 30 NovoLet Insulinum humanum susp. for inj. 100IU/ml 3ml cartridges N5 Novo Nordisk<br />

3506. Mixtard 30FlexPen Insulinum humanum (rDNA) suspension for<br />

injection<br />

100 IU/ml 3ml cartridge+<br />

pre-filled pen with needle N5<br />

3507. Mixtard 40 HM Penfill Insulinum humanum susp. for inj. 100IU(3,5mg)/ml cartrige 3ml<br />

N5<br />

3508. Mixtard 50 HM Penfill Insulinum humanum susp. for inj. 100IU(3,5mg)/ml cartrige 3ml<br />

N5<br />

3509. Mizollen Mizolastinum film-coated<br />

modified-release<br />

tab.<br />

3510. Mobilat Mucopolysaccharidi polysulfas<br />

+Acidum Salicylicum+<br />

Suprarenali extractum<br />

3511. Mobilat Mucopolysaccharidi polysulfas<br />

+Acidum salicylicum+<br />

Suprarenali extractum<br />

3512. Modafen Ibuprofenum+<br />

Pseudoephedrini<br />

hydrochloridum<br />

Novo Nordisk A/S<br />

Novo Nordisk<br />

Novo Nordisk<br />

10mg N10; N15 Synthelabo<br />

cream 0,2g+2g+1g/100g 50g; 100g Sankyo Pharma<br />

gel 0,2g+2g+1g/100g 50g; 100g Sankyo Pharma<br />

film coated tab. 200mg+ 30mg N10;N30 Lečiva<br />

3513. Moditen depo Fluphenazinum sol. for inj. 25mg/ml 1ml amp. N5 KRKA<br />

3514. Moduretic Amiloridum+<br />

Hydrochlorothiazidum<br />

3515. Modustatine Somatostatinum powder and<br />

solvent for sol.<br />

for inj.<br />

tab. 5mg+50mg N30 MSD<br />

2mg/2ml (2mg/vial+ 2ml<br />

amp.) N1<br />

Sanofi Winthrop<br />

3516. Moex 15 Moexiprili hydrochloridum film-coated tab. 15mg N30 Schwarz Pharma<br />

3517. Moex 7,5 Moexiprili hydrochloridum film-coated tab. 7,5mg N30 Schwarz Pharma<br />

3518. Molsidomina Molsidominum tab. 4mg N30 Polfa Warsaw<br />

3519. Molsidomina Molsidominum tab. 2mg N30 Polfa Warsaw<br />

3520. Molsidomina prolongatum<br />

8mg<br />

Molsidominum tab. 8mg N30 Polfa Warsaw<br />

3521. Mono Mack 20 mg Isosorbidi mononitras tab. 20mg<br />

N50<br />

3522. Mono Mack 40 mg Isosorbidi mononitras tab. 40mg<br />

N50<br />

3523. Mono Mack Depot Isosorbidi mononitras sustainedrelease<br />

tab.<br />

3524. Monolong 40 Isosorbidi mononitras sustainedrelease<br />

caps.<br />

100mg<br />

N20<br />

40mg<br />

N30<br />

Mack<br />

Mack<br />

Mack<br />

CTS


EN<br />

274 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3525. Monolong 60 Isosorbidi mononitras sustainedrelease<br />

caps.<br />

3526. Monopril Fosinoprilum tab. 20mg<br />

N30<br />

3527. Monopril Fosinoprilum tab. 10mg<br />

N20<br />

Strength Manufacturer<br />

60mg N30 CTS<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

3528. Monosan Isosorbidi mononitras tab. 40mg N30 Pro. Med. CS Praha<br />

3529. Monosan Isosorbidi mononitras tab. 20mg N30 Pro. Med. CS Praha<br />

3530. Monosuinsulinas MK<br />

100 TV/ml<br />

3531. Monotest Tuberculin Purified Protein<br />

Derivative (PPD) for human<br />

use<br />

Insulinum suis MK susp. for inj. 100UI/ml 10ml vial Endokrini-niai<br />

preparatai<br />

sol.ultipuncture:<br />

applicator for<br />

multiple<br />

puncture<br />

30000000IU/100ml Pasteur Merieux<br />

3532. Mono-Tildiem SR Diltiazemum caps. 300mg Synthelabo<br />

3533. Mono-Tildiem SR Diltiazemum caps. 200mg Synthelabo<br />

3534. Monovitan C Acidum ascorbicum coated tab. 200mg<br />

N30<br />

3535. Monovitan C Acidum ascorbicum coated tab. 100mg<br />

N30<br />

3536. Monozide Fosinoprilum +<br />

Hydrochlorothiazidum<br />

3537. Montana Haustropfen Lupuli strob.+ Gentianae<br />

radix+ Cinnamomi cortex+<br />

Aurantii amari pericarpium+<br />

Carvi fructus+ Taraxaci radix+<br />

Menthae piperitae aetheroleum<br />

Pliva Krakow<br />

Pliva Krakow<br />

tablets 20mg+12,5mg N28 or N30 Bristol-Myers Squibb<br />

S.p.a.<br />

oral drops 1g+2g+1g+2g+1g+3g+<br />

60mg/100ml (Ethanolum<br />

48 vol.-%) 50ml; 200ml;<br />

500ml<br />

Pharmonta<br />

3538. Morfin DAK 0,4 mg/ml Morphini hydrochloridum sol. for inj. 0,4mg/ml, amp.10ml N50 Nycomed Pharma<br />

3539. Morfino hidrochlorido<br />

1 % tirpalas injekcijoms<br />

Morphini hydrochloridum sol. for inj. 10mg/ml<br />

N10 po1ml<br />

Endokrini-niai<br />

preparatai<br />

3540. Morphin Biotika 1 % Morphini hydrochloridum sol. for inj. 10mg/ml amp. N10 Hoechst Biotika<br />

3541. Morphine Morphini hydrochloridum sol. for inj. 10mg/ml 1ml N10; 2ml N10 Icelandic<br />

Pharmaceuticals<br />

3542. Morphini sulfas Morphini sulfas sol. for inj. 10mg/ml 1ml amp. N10 Polfa Warsaw<br />

3543. Morphini sulfas Morphini sulfas sol.for inj. 20mg/ml 1ml amp. N10 Polfa Warsaw<br />

3544. Morphinum hydrochloricum Morphinum sol. for inj. 20mg/ml<br />

N10 po 1ml<br />

3545. Morphinum hydrochloricum Morphinum sol. for inj. 10mg/ml<br />

N10 po 1ml<br />

Polfa Warsaw<br />

Polfa Warsaw<br />

3546. Motilium Domperidonum film-coated tab. 10mg N10;N30 Janssen-Cilag<br />

3547. Motilium lingual Domperidonum tab. 10mg N10;N30 Scherer DDS<br />

3548. Motrin vaikams (apelsinu˛<br />

skonio)<br />

Ibuprofenum chewable tab. 50mg<br />

N24<br />

McNeil/ Grindeks


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 275<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3549. Movalis Meloxicamum supp. 7,5mg N6 Boehringer<br />

Ingelheim<br />

3550. Movalis<br />

15 mg/1,5 ml<br />

Meloxicamum sol. for inj. 15mg/1,5ml amp. N5 Boehringer<br />

Ingelheim<br />

3551. Movalis Meloxicamum oral suspension 7,5mg/5ml 100ml Boehringer<br />

Ingelheim Pharma<br />

KG<br />

3552. Movalis 15mg Meloxicamum tab. 15mg<br />

N20<br />

3553. Movalis 7,5mg Meloxicamum tab. 7,5mg<br />

N20; N50<br />

3554. MS Contin Morphinum supp. 30mg<br />

N24<br />

3555. MS Contin Morphinum supp. 200mg<br />

N24<br />

3556. MS Contin Morphinum supp. 100mg<br />

N24<br />

3557. MS Contin Morphinum supp. 60mg<br />

N24<br />

Boehringer<br />

Ingelheim<br />

Boehringer<br />

Ingelheim<br />

Purdue Frederick<br />

Purdue Frederick<br />

Purdue Frederick<br />

Purdue Frederick<br />

3558. MSI 10 Mundipharma Morphini sulfas pentahydricus sol. for inj. 10mg/ml amp. N10 Mundipharma<br />

3559. MSI 100 Mundipharma Morphini sulfas pentahydricus sol. for inj. 100mg/5ml 5ml amp. N5 Mundipharma<br />

3560. MSI 20 Mundipharma Morphini sulfas pentahydricus sol. for inj. 20mg/ml amp. N10 Mundipharma<br />

3561. MSI 200 Mundipharma Morphini sulfas pentahydricus sol. for inj. 200mg/10ml 10ml amp. N5 Mundipharma<br />

3562. MST Continus Morphini sulfas modified-release<br />

gran. for oral<br />

susp.<br />

3563. MST Continus Morphini sulfas modified-release<br />

gran. for oral<br />

susp.<br />

3564. MST Continus Morphini sulfas modified-release<br />

gran. for oral<br />

susp.<br />

3565. MST Continus Morphini sulfas modified-release<br />

gran. for oral<br />

susp.<br />

3566. MST Continus Morphini sulfas modified-release<br />

gran. for oral<br />

susp.<br />

30mg/sachet N30 Bard Pharmaceuticals<br />

100mg/sachet N30 Bard Pharmaceuticals<br />

200mg/sachet N30 Bard Pharmaceuticals<br />

20mg/sachet N30 Bard Pharmaceuticals<br />

60mg/sachet N30 Bard Pharmaceuticals<br />

3567. Mucaltinum Mucaltinum tab. 50mg N10; N20; N30; N50 Liuks<br />

3568. Mucinum (with Cascara<br />

extract)<br />

Cascara skin extract+Senna<br />

leaves extract+ Pulverised<br />

Boldo leaves+ Pulverised Green<br />

Anise<br />

3569. Mucofalk granule˙s (Apelsinas) Plantaginis ovatae seminis<br />

tegumentum<br />

coated tab. 40mg+30mg+50mg+30mg<br />

N20<br />

gran. 3,25g/5g;<br />

150g N20<br />

3570. Mucofluid 100 Acetylcysteinum solubile tab. 100mg N30 Spirig<br />

3571. Mucofluid 200 Acetylcysteinum solubile tab. 200mg N30 Spirig<br />

Innothera Laboratory<br />

Falk/Klocke Pharma-<br />

Service


EN<br />

276 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3572. Mucokehl D5 Drops Mucor racemosus D5 drops, solution 10ml Sanum-Kehlbeck<br />

GmbH & Co KG<br />

3573. Mucopront Carbocisteinum syrup 250mg/5g 200ml Mack<br />

3574. Mucopront Carbocisteinum caps. 375mg<br />

N20<br />

3575. Mucosol 250 Carbocisteinum syrup 250mg/5g 110ml CTS<br />

3576. Mucosol 375 Carbocisteinum sustained-releas<br />

caps.<br />

Mack<br />

375mg N20 CTS<br />

3577. Mukaltino tablete˙s Mucaltin tab. 0,05 N10 Liuks<br />

3578. Mukolin 2 % Carbocisteinum syrup 2g/100ml 120ml Pliva Krakow<br />

3579. Mukolin 5 % Carbocisteinum syrup 5g/100ml 120ml Pliva Krakow<br />

3580. Mulimen Vitex agnuscastus D3 +<br />

Cimicifuga racemosa D4+<br />

Ambra grisea D4 + Hypericum<br />

perforatum D3+ Urtica urens<br />

D3+ Sepia officinalis D8+<br />

Calcium carbonicum<br />

Hahnemanni D8+ Kalium<br />

carbonicum D4+ Gelsemium<br />

sempervirens D4<br />

3581. Multi-B strong Thiaminum+Nicotinamidum+<br />

Riboflavinum+Calcii<br />

pantothenas+Pyridoxinum+<br />

Cyanocobalaminum+ Biotinum<br />

3582. Multiload Cu 375 Copper wire area 349-<br />

393 mm 2<br />

3583. Multi-tabs multivitamin with<br />

beta-carotene<br />

3584. Multi-tabs multivitamin with<br />

minerals<br />

3585. Multi-tabs tasty chewable<br />

tablets 1-4 years<br />

Retinolum+ Colecalciferolum+<br />

Tocopherolum+ Thiaminum+<br />

Riboflavinum+ Pyridoxinum+<br />

Cyanocobalaminum+<br />

Nicotinamidum+ Calcii<br />

pantothenas+ Acidum<br />

folicum+ Acidum ascorbicum+<br />

Betacarotenum+ Magnesium+<br />

Ferrum+ Zincum+ Cuprum+<br />

Manganum+ Molybdenum+<br />

Chromium(III)+ Selenium+<br />

Iodum<br />

Retinolum+Colecalciferolum+<br />

Tocopherolum+ Thiaminum+<br />

Riboflavinum+Pyridoxinum+<br />

Cyanocobalaminum+<br />

Nicotinamidum+Acidum<br />

pantothenicum+ Acidum<br />

folicum<br />

+Acidum ascorbicum +<br />

Magnesium +Ferrum+Zincum+<br />

Cuprum+Manganum+<br />

Molybdenum+ Cromium(III)+<br />

Selenium+Iodum<br />

Retinolum+ Colecalciferolum+<br />

Tocopherolum+ Thiaminum+<br />

Riboflavinum+ Pyridoxinum+<br />

Cyanocobalaminum+<br />

Nicotinamidum+ Acidum<br />

pantothe-nicum+ Acidum<br />

folicum+ Acidum ascorbicum+<br />

Ferrum+ Zincum + Cuprum+<br />

Manganum+ Chromium(III)+<br />

Selenium+Iodum<br />

tab. 33,33mg+ 33,33mg+<br />

33,33mg+ 33,33mg+<br />

33,33mg+ 33,33mg+<br />

33,33mg+ 33,33mg+<br />

33,33mg N50; N100<br />

film-coated tab. 15mg+50mg+<br />

15mg+25mg+<br />

10mg+10µg+<br />

150µg N30; N100; N250<br />

intrauterine<br />

device<br />

Heel<br />

Vitabalans<br />

N1 Multilan<br />

tab. 1 237IU + 200IU+11IU+<br />

1,5mg+ 1,7mg+ 2,2mg+ 3µg+<br />

19mg+6mg+100µg+ 60mg+<br />

3,78mg+ 100mg+ 18mg+<br />

15mg+ 2,5mg+ 3,8mg+<br />

250µg+ 125µg+ 125µcg+<br />

150µg N80<br />

tab. 3333IU+200IU+11IU+1,5mg+<br />

1,7mg+2,2mg+3µg+19mg+<br />

6mg+100µg+<br />

60mg+100mg+18mg+ 15mg+<br />

2,5mg+3,8mg+ 250µg+<br />

125µg+125µg+<br />

150µg N100<br />

tab. 1 333IU+ 400IU+ 7,45IU+<br />

0,7mg+ 0,8mg+ 0,9mg+1µg+<br />

9mg+3mg+ 20µg+ 40mg+<br />

10mg+5mg+1mg+1mg+<br />

20µg+ 25µg+70µg N30<br />

Ferrosan<br />

Ferrosan<br />

Ferrosan


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 277<br />

No. Commercial name General name<br />

3586. Multi-tabs tasty chewable<br />

tablets for adults and children<br />

from 4 years<br />

Retinolum+ Colecalciferolum+<br />

Tocopherolum+ Thiaminum+<br />

Riboflavinum+ Pyridoxinum+<br />

Cyanocobalaminum+<br />

Nicotinamidum+ Acidum<br />

pantothenicum+ Acidum<br />

folicum+ Acidum ascorbicum+<br />

Ferrum +Zincum+ Cuprum+<br />

Manganum+ Chromium (III) +<br />

Selenium+ Iodum<br />

3587. Multi-tabs vitamin ACD drops Retinol palmitate+<br />

Colecalciferol+ Ascorbic acid<br />

3588. Multivitaminu˛ ir multimineralu˛<br />

kompleksas<br />

Pharmaceutical<br />

form<br />

chewable tab. 2 666IU+ 200IU+ 14,9IU+<br />

1,4mg+ 1,6mg+ 2mg+1µg+<br />

18mg+6mg+100µg+ 60mg+<br />

14mg+ 15mg+2mg+2,5mg+<br />

50µg+ 50µg+150µg N30<br />

drops 1 000IU+ 400IU+ 35mg/ml<br />

30ml<br />

Strength Manufacturer<br />

Ferrosan<br />

Ferrosan<br />

Multivitaminai, multimineralai tab., caps N30; N50; N60 Liuks<br />

3589. Multivitaminu˛ kompleksas Multivitaminai tab., caps N30; N50; N60 Liuks<br />

3590. Mundisal Gel Cholini salicylas gel 87,1mg/g 8g Mundipharma<br />

3591. Muscuron Pancuronii bromidum sol. for inj. 2mg/ml N5 Sun<br />

3592. Muse Alprostadilum transurethral<br />

stick<br />

3593. Muse Alprostadilum transurethral<br />

stick<br />

3594. Muse Alprostadilum transurethral<br />

stick<br />

3595. Muse Alprostadilum transurethral<br />

stick<br />

3596. Mutaflor E.coli strain NISSLE 1917 2,5-<br />

25×10*9 viable bacteria<br />

3597. Mutamycin Mitomycinum powder for sol.<br />

for inj. i.v.<br />

3598. Mutamycin Mitomycinum powder for sol.<br />

for inj. i.v.<br />

3599. Mutamycin Mitomycinum powder for sol.<br />

for inj. i.v.<br />

3600. MXL Capsules Morphini sulfas controlledrelease<br />

caps.<br />

3601. MXL Capsules Morphini sulfas controlledrelease<br />

caps.<br />

3602. MXL Capsules Morphini sulfas controlledrelease<br />

caps.<br />

3603. MXL Capsules Morphini sulfas controlledrelease<br />

caps.<br />

3604. MXL Capsules Morphini sulfas controlledrelease<br />

caps.<br />

3605. MXL Capsules Morphini sulfas controlledrelease<br />

caps.<br />

125µg N1; N6 Astra<br />

500µg N1; N6 Astra<br />

1000µg N1; N6 Astra<br />

250µg N1; N6 Astra<br />

caps. 100mg N20;N100 Ardeypharm<br />

40mg<br />

N1<br />

20mg<br />

N1<br />

5mg<br />

N1<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

30mg N28 Bard Pharmaceuticals<br />

of Napp Laboratories<br />

60mg N28 Bard Pharmaceuticals<br />

of Napp Laboratories<br />

120mg N28 Bard Pharmaceuticals<br />

of Napp Laboratories<br />

150mg N28 Bard Pharmaceuticals<br />

of Napp Laboratories<br />

200mg N28 Bard Pharmaceuticals<br />

of Napp Laboratories<br />

90mg N28 Bard Pharmaceuticals<br />

of Napp Laboratories<br />

3606. Mycomax 100 Fluconazolum caps. 100mg N7;N28; N70 Lečiva<br />

3607. Mycomax 150 Fluconazolum caps. 150mg N1 Lečiva<br />

3608. Mycomax 200 Fluconazolum caps. 200mg N7 Lečiva


EN<br />

278 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3609. Mycomax 50 Fluconazolum caps. 50mg N7;N28; N70 Lečiva<br />

3610. Mycomax inf Fluconazolum sol.for inf. 200mg/100ml 100ml Lečiva<br />

3611. Mycomax sir Fluconazolum syrup 5mg/ml 100ml Lečiva<br />

3612. Mycosolon Mazipredoni hydrochloridum+<br />

Miconazolum<br />

ointment 37,5mg+ 300mg/15g Gedeon Richter<br />

3613. Mycosyst 100 mg capsules Fluconazolum caps. 100mg N28 Gedeon Richter<br />

3614. Mycosyst 150 mg capsules Fluconazolum caps. 150mg N1; N2 Gedeon Richter<br />

3615. Mycosyst 2 mg/ml solution for<br />

infusion<br />

3616. Mycosyst<br />

50 mg capsules<br />

Fluconazolum sol. for inf. 2mg/ml 100ml N1; N10 Gedeon Richter<br />

Fluconazolum caps. 50mg N7 Gedeon Richter<br />

3617. Mydocalm Tolperisonum film-coated tab. 150mg<br />

N30<br />

3618. Mydocalm Tolperisonum film-coated tab. 50mg<br />

N30<br />

3619. Mydocalm Tolperisonum+<br />

Lidocainum<br />

sol. for inj. 100mg+2,5mg/ml 1ml amp.<br />

N5<br />

3620. Mydriacyl Tropicamidum eye drops, sol. 5mg/ml<br />

15ml<br />

Gedeon Richter<br />

Gedeon Richter<br />

Gedeon Richter<br />

Alcon-Couvreur<br />

3621. Mydriacyl 1 % Tropicamidum eye drops, sol. 10mg/ml 15ml Alcon-Couvreur<br />

3622. Myfungar Oxiconazolum cream 1g/100g 30g Lečiva<br />

3623. Mykoseptin Acidum undecylenicum+ Zinci<br />

undecylenas<br />

3624. Myleran Busulfanum coated tab. 2mg<br />

N100<br />

3625. Myolastan 50mg Tetrazepamum scored coated<br />

tab.<br />

3626. Myoview (Kit for the<br />

preparation of Technetium<br />

[(99m)Tc] Tetrofosmin)<br />

Tetrofosmin powder for<br />

sol.for inj.<br />

(diagnostic<br />

agent)<br />

3627. Myramystene Myristamidopropyldimethylbenzene<br />

ammonia chloride<br />

3628. Naaxia N-acetyl aspartyl-glutamic acid,<br />

sodium salt<br />

ointment 1,5g+ 6g/30g Lečiva<br />

50mg<br />

N20<br />

sol. 0,01%<br />

100ml; 500ml<br />

3629. Naclof 0,1 % Diclofenacum eye drops, sol. 1mg/ml<br />

5ml<br />

3630. NAC-ratiopharm 200<br />

Brausetabletten<br />

Wellcome<br />

Sanofi Winthrop<br />

0,23mg/vial N2; N5 Nycomed Amersham<br />

Flobi<br />

eye drops, sol. 49mg/ml 5ml Ciba Vision Faure<br />

Acetylcysteinum efferv. tab. 200mg N20;N50 Merckle<br />

3631. NAC-ratiopharm 200 Sachet Acetylcysteinum granules for<br />

oral sol.<br />

200mg/ sachet (2g ) N20, N50 Merckle<br />

3632. Naftizin 0,05% Naphazolinum sol. 0,5mg/ml 10ml Farmak<br />

3633. Naftizin 0,05% Naphazolinum sol. 0,05%10 ml Liuks<br />

3634. Naftizin 0,1% Naphazolinum sol. 1mg/ml 10ml Farmak<br />

Laboratoires Ciba<br />

Vision Faure


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 279<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3635. Naftizin 0,1% Naphazolinum sol. 0,1% 10ml Liuks<br />

3636. Naklofen Diclofenacum gastro- resistant<br />

tab.<br />

3637. Naklofen Diclofenacum supp. 50mg N10 KRKA<br />

3638. Naklofen Diclofenacum sol. for inj. 75mg/3ml amp. N5 KRKA<br />

3639. Naklofen Diclofenacum prolon- ged<br />

release tab.<br />

50mg<br />

N20<br />

100mg<br />

N20<br />

3640. Naklofen Diclofenacum gel 10mg/g 60g KRKA<br />

3641. Naklofen duo Diclofenacum caps. 75mg (25mg skrandzˇio<br />

rūgšties poveikiui atsparia ir<br />

50mg prailginto veikimo<br />

forma) N20<br />

3642. Nakom tablets 25/250 mg Carbidopum+ Levodopum tab. 25mg+ 250mg N100 Lek<br />

3643. Nalgesin forte Naproxenum natricum coated tab. 550mg<br />

N10<br />

3644. Nalgesin S Naproxenum natricum coated tab. 275mg<br />

N10<br />

3645. Nalidikso rūgštis Acidum nalidixicum caps. 0,5g N20 Liuks<br />

3646. Naloxoni hydrochloridum Naloxoni hydrochloridum sol. for inj. 0,4mg/ml 1ml amp.N10 Polfa Warsaw<br />

3647. Naniprus Natrii nitroprussias powder and<br />

solvent for sol.<br />

for inf.<br />

3648. Nanocoll (Kit for the<br />

preparation of Technetium<br />

[99mTc] Albumin Nanocolloid<br />

Injection)<br />

Human albumin colloidal<br />

particles+ Stannous chloride<br />

dihydrate<br />

powder for<br />

i.v.or<br />

subcutaneus inj.<br />

30mg/amp. +5ml solvent<br />

N1<br />

0,5mg+ 0,2mg/vial<br />

N5<br />

KRKA<br />

KRKA<br />

KRKA<br />

KRKA<br />

KRKA<br />

Sopharma PLC<br />

Nycomed Amersham<br />

3649. Naoxintong compos. caps. 400mg Xianyang Buchang<br />

Pharmaceutical<br />

Co.Ltd.<br />

3650. Naphazol 0,1 % Naphazolinum nasal drops,<br />

solution<br />

3651. Naphazol 0,05 % Naphazolinum nasal drops,<br />

solution<br />

3652. Naprokseno 250mg tablete˙s Naproxenum tab. 250mg<br />

N25<br />

1mg/ml 10ml Norfachema UAB<br />

0,5mg/ml 10ml Norfachema UAB<br />

3653. Naprokseno tablete˙s Naproxenum tab. 0,25 N10 Liuks<br />

3654. Naproksens 250 mg Naproxenum tab. 250mg<br />

N30<br />

3655. Naproksens 500 mg Naproxenum tab. 500mg<br />

N30<br />

3656. Naprosyn Naproxenum tab. 250mg N30;N50 KRKA<br />

3657. Naprosyn Naproxenum supp. 500mg N10 KRKA<br />

Endokrininiai<br />

preparatai<br />

Grindeks<br />

Grindeks<br />

3658. Naproxen Naproxenum tab. 500mg N20 Polfa Pabianice<br />

3659. Naproxen Naproxenum oral susp. 125mg/5ml 100ml; 500ml Polfa Pabianice


EN<br />

280 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3660. Naproxen Naproxenum tab. 250mg N50 Polfa Pabianice<br />

3661. Naramig Naratriptanum tab. 2,5mg N2;N4;N6; N12 Glaxo Wellcome<br />

3662. Narcotan Halothanum liq. 250ml Lečiva<br />

3663. Nasacort Triamcinolonum nasal spray 55µg/dose 120doses Rhone-Poulenc<br />

Rorer<br />

3664. Nasen Spray E ratiopharm be<br />

konservantu˛<br />

3665. Nasen Spray K ratiopharm be<br />

konservantu˛<br />

Xylometazolini<br />

hydrochloridum<br />

Xylometazolini<br />

hydrochloridum<br />

nasal spray 1mg/ml 10ml Merckle<br />

nasal spray 0,5mg/ml 10ml Merckle<br />

3666. Nasivin for colds Oxymetazolinum sol. 0,1mg/ml 5ml Merck<br />

3667. Nasivin nasal drops Oxymetazolinum nasal drops 0,05% 500µg/ml 10;20ml Merck<br />

3668. Nasivin nasal drops Oxymetazolinum nasal drops 0,025% 250µg/ml 10;20ml Merck<br />

3669. Nasivin nasal spray Oxymetazolinum nasal spray 0,05% 500µg/ml 10ml Merck<br />

3670. Našlaičiu˛ zˇole˙ (smulkinta) Herba Violae herbal tea 100g; 50g; 50g (2g×25) Švenčioniu˛<br />

vaistazˇole˙s<br />

3671. Našlaite˙s zˇole˙ Herb. Violae tricoloris herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

3672. Nasobec Beclometasonum nasal spray 50µg/dose 200 doses Galena<br />

3673. Naso-Heel S Cistus canadensis D4+ Arum<br />

maculatum D4+<br />

Melilotus off. D3+<br />

Vinca minor D3+<br />

Veronica off. D3+<br />

Mercuris bijodatus D8+<br />

Ammonium carb. D3+ Lemna<br />

minor D3+<br />

Cinnabaris D8+<br />

Sticta D4+<br />

Phosphorus D6+<br />

Kalium bichromic. D5+<br />

Hydrastis canaden. D4+<br />

Natrium tetrachloroauratum<br />

D6<br />

drops 5g+5g+5g+5g+5g+5g+5g+5g+<br />

10g+10g+10g+10g+10g+<br />

10g/100g (Ethanolum 35%)<br />

N30ml; 100ml<br />

3674. Naso-Heel SN compos. drops 30ml Biologische<br />

Heilmittel Heel<br />

GmbH<br />

3675. Nasonex Mometasonum nasal spray,<br />

susp.<br />

3676. Natrii adenosintriphosphas 1%<br />

1ml inj.<br />

3677. Natrii chloridum 0,9 % pro<br />

infusionibus<br />

3678. Natrii desoxyribo-nucleas<br />

(Dezoksiribo-nukleaze˙ (DNR-<br />

Na))<br />

0,5mg/g<br />

18g<br />

Heel<br />

SP Labo<br />

Natrii adenosintriphosphas sol. 1% 1ml N10 Liuks<br />

Natrii chloridum sol. for inf. 0,9g/100ml 500ml Balkanpharma-<br />

Troyan<br />

Natrii desoxyribonucleas subst. 50g; 100g; 150g; 250g Technomedservis<br />

UAB<br />

3679. Natrii hydrocarbonas Natrii hydrocarbonas powder 50g; 100g; 250g; 1000g Hasco-Lek<br />

3680. Natrija diklofenaks 25 mg Diclofenacum natricum coated tab. 25mg<br />

N30<br />

OlainFarm


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 281<br />

No. Commercial name General name<br />

3681. Natrija fluorides<br />

2,2 mg (me˙tu˛ skonio, vaikams)<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

Natrii fluoridum tab. 2,2mg N250 Grindeks<br />

3682. Natrija fluorids Natrii fluoridum tab. 2,2mg N250 Grindex<br />

3683. Natrija fluorids 1,1mg<br />

(apelsinu˛ skonio, vaikams)<br />

Natrii fluoridum tab. 1,1mg N250 Grindeks<br />

3684. Natrija Hlorids 0,9 % Natrii chloridum sol. for inf. 0,9g/100ml (100ml; 250ml;<br />

500ml; 3000ml plastic bags<br />

with 3 year shelf-life); 250ml;<br />

500ml;1000ml ‘Propyflex’ with<br />

2 year shelf-life<br />

3685. Natrija hlorids 10 % sterils<br />

škidums skalošanai<br />

3686. Natrio chlorido 0,9 % tirpalas<br />

infuzijoms<br />

3687. Natrio chlorido izotoninis<br />

0,9 % tirpalas injekcijoms<br />

3688. Natrio chlorido izotoninis<br />

0,9 % tirpalas injekcijoms<br />

3689. Natrio kromoglikato 2 %<br />

tirpalas-akiu˛ lašai<br />

3690. Natrio kromoglikato 4 %<br />

tirpalas-akiu˛ lašai<br />

Grindeks<br />

Natrii chloridum sol.for irrigation 100g/1000ml 160ml Grindeks<br />

Natrii chloridum sol. for inf. 9g/1000ml 100ml; 250ml;<br />

500ml; 1 000ml<br />

Natrii chloridum sol. for inj. 9mg/ml<br />

5ml amp. N10<br />

Natrii chloridum sol. for inj. 9mg/ml<br />

5ml amp. N10<br />

Natrii cromoglicas eye drops,sol. 20mg/ml 1,5ml ampule˙s-lašintuvai<br />

N10; 5ml<br />

Natrii cromoglicas eye drops,sol. 40mg/ml 1,5ml ampule˙s-lašintuvai<br />

N10; 5ml<br />

3691. Natūralus bičiu˛ pienelis Apilacum naturale tab. 70mg<br />

N20<br />

3692. Navelbine Vinorelbinum sol. for inj. 50mg/5ml<br />

N10<br />

3693. Navelbine Vinorelbinum sol. for inj. 10mg/ml<br />

N10<br />

3694. Navoban Tropisetronum sol. for inj./inf. 2mg/2ml<br />

N1<br />

3695. Navoban Tropisetronum sol. for inj. 1mg/ml<br />

5ml amp. N1<br />

Ilsanta/ Fresenius<br />

Kabi Polska<br />

Sanitas<br />

Endokrininiai<br />

preparatai<br />

Endokrininiai<br />

preparatai<br />

Endokrininiai<br />

preparatai<br />

Sanitas<br />

Pierre Fabre<br />

Pierre Fabre<br />

3696. Navoban Tropisetronum caps. 5mg N5 Novartis<br />

3697. Nazol Oxymetazolinum spray 0,5mg/ml 30ml Perrigo<br />

3698. Nebcin Tobramycinum sol. for inj. 80mg/2ml<br />

vial N1<br />

3699. Nebilet Nebivololum tab. 5mg<br />

N14<br />

Sandoz Pharma /<br />

Boehringer<br />

Ingelheim<br />

Novartis Pharma<br />

Lilly France<br />

3700. Nefrocarnit Levocarnitinum sol.for inj. 1g/5ml N10; N25 Medice<br />

3701. Nefrocarnit Levocarnitinum syrup 1g/3,3ml 50ml Medice<br />

3702. Nefrol Alcoholic tinctura (1:7)<br />

Herb.Solida-ginis virgaureae +<br />

Rad.Rubiae tinctori+Fruct.<br />

Ammi visnagae+ Rad.cum<br />

herb. Taraxaci+Rad.<br />

Echinaceae purpureae+Fruct.<br />

Petroselini sativi+ Peric.<br />

Phaseoli vulgaris + Ethanolum<br />

70%<br />

tinct. 4,05partis+ 3,02partis+<br />

2,14partis+ 2,91partis+<br />

0,81partis+ 0,77partis+<br />

0,55partis+ 100partis 125ml<br />

Berlin-Chemie<br />

(Menarini Group)<br />

Herbapol Cracow


EN<br />

282 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

3703. NeisVac-C Neisseria meningitidis C (strain<br />

C11) polysaccharide (de-Oacetylated)+<br />

Conjugated to tetanus toxoid<br />

Pharmaceutical<br />

form<br />

susp. for inj. 10µg+10-20µg/dose 0,5ml<br />

pre-filled syringe N1<br />

3704. Neloren Lincomycinum sol.for inj. 300mg/ml<br />

1ml amp. N10<br />

Strength Manufacturer<br />

3705. Neloren Lincomycinum sol.for inj. 600mg/2ml amp. N10 Lek<br />

3706. Neo Borocillina Alcohol 2,4-dichlorbenzylicus+<br />

Natrii benzoas<br />

3707. Neo Borocillina C 2,4 dichlorobenzyl alcohol+<br />

ascorbic acid<br />

3708. neo-angin N be cukraus Alcohol 2,4-dichlorbenzylicus+<br />

Mentholum+<br />

Amylmetacresolum<br />

3709. neo-angin N pastile˙s nuo<br />

gerkle˙s skausmo<br />

Alcohol 2,4-dichlorbenzylicus+<br />

Mentholum+<br />

Amylmetacresolum<br />

3710. Neoaskofenas Acidum acetylsalicylicum+<br />

Paracetamolum+ Coffeinum<br />

3711. Neocitramonas Acidum acetylsalicylicum+<br />

Paracetamolum+ Coffeinum<br />

Cook Pharmaceutical<br />

Solutions<br />

orosoluble tab. 1,2mg+20mg N20 Alfa Wassermann<br />

soluble tablets 1,2mg+70mg N20 Alfa Wassermann<br />

S.p.A.<br />

lozenges 1,2mg+ 5,72mg+ 0,6mg<br />

N24<br />

lozenges 1,2mg+ 5,9mg+ 0,6mg<br />

N24<br />

tab. 200mg+ 200mg+ 40mg N50;<br />

N100<br />

tab. 240mg+ 200mg+ 30mg N50;<br />

N100<br />

Lek<br />

Divapharma-<br />

Knufinke<br />

Divapharma-<br />

Knufinke<br />

3712. Neomigran Nasal Spray Dihydroergotaminum nasal spray, sol. 4mg/ml 4 doses Mipharm<br />

3713. Neonutrin 10 % Isoleucinum+ Leucinum+<br />

Lysinum+Methioninum+<br />

Phenylalaninum+Threoninum+<br />

Tryptophanum+Valinum+<br />

Histidinum+Acetylcysteinum+<br />

Cystinum+Glycylthyrosinum+<br />

Tyrosinum+Alaninum+<br />

Argininum+Acidum<br />

asparticum+ Asparaginum+<br />

Acidum glutamicum+<br />

Glycinum+Prolinum+ Serinum<br />

3714. Neonutrin 15 % Isoleucinum+ Leucinum+<br />

Lysinum+Methioninum+<br />

Phenylalaninum+Threoninum+<br />

Tryptophanum+Valinum+<br />

Histidinum+Acetylcysteinum+<br />

Cystinum+Glycylthyrosinum+<br />

Tyrosinum+Alaninum+<br />

Argininum+Acidum<br />

asparticum+ Asparaginum+<br />

Acidum glutamicum+<br />

Glycinum+Prolinum+ Serinum<br />

3715. Neonutrin 5 % Isoleucinum+ Leucinum+<br />

Lysinum+Methioninum+<br />

Phenylalaninum+Threoninum+<br />

Tryptophanum+Valinum+<br />

Histidinum+Acetylcysteinum+<br />

Cystinum+Glycylthyrosinum+<br />

Tyrosinum+Alaninum+<br />

Argininum+Acidum<br />

asparticum+ Asparaginum+<br />

Acidum glutamicum+<br />

Glycinum+Prolinum+ Serinum<br />

sol. for inf. 5g+8g+8,1g+3,5g+6,5g+4,4g+<br />

2,2g+7g+3,5g+1,2g+0,4g+3g+<br />

0,3g+6g+ 9g+3,5g+4g+10g+<br />

5,5g+ 6g+4g/1000ml 500ml<br />

sol. for inf. 7,5g+12g+ 12,15g+ 5,25g+<br />

9,75g+6,6g+3,3g+10,5g+<br />

5,25g+1,8g+0,4g+4,5g+0,3g+<br />

9g+13,5g+ 5,25g+6g+ 15g+<br />

8,25g+ 9g+6g/ 1000ml 500ml<br />

sol. for inf. 2,5g+4g+4,05g+1,75g +<br />

3,25g+2,2g+1,1g+3,5g+<br />

1,75g+0,6g+0,4g+1,5g+0,3g+<br />

3g+4,5g+1,75g+2g+ 5g+<br />

2,75g+3g+2g/1000ml 500ml<br />

Sanitas<br />

Sanitas<br />

Infusia<br />

Infusia<br />

Infusia


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 283<br />

No. Commercial name General name<br />

3716. Neonutrin 4% Isoleucinum+<br />

Leucinum+ Lysinum<br />

hydrochloridum+<br />

Methioninum+<br />

Phenylalaninum +<br />

Threoninum+ Tryptophanum<br />

+ Valinum+ Acetyltyrosinum +<br />

Glycinum + Acidum<br />

asparticum + Acidum<br />

glutamicum + Alaninum +<br />

Argininum + Cystinum +<br />

Histidinum+ Prolinum+<br />

Serinum+ Acidum malicum+<br />

Kalii acetas+ Magnesii<br />

3717. Neonutrin 8% Isoleucinum+ Leucinum+<br />

Lysini hydrochloridum+<br />

Methioninum+<br />

Phenylalaninum+<br />

Threoninum+ Tryptophanum<br />

+ Valinum + Acetyltyrosinum<br />

+Glycinum+Acidum<br />

asparticum+ Acidum<br />

glutamicum+ Alaninum+<br />

Argininum+ Cystinum +<br />

Histidinum+ Prolinum+<br />

Serinum+ Acidum malicum+<br />

Kalii acetas+ Magnesii<br />

3718. NeoRecormon Epoetinum beta<br />

(Erythropoietinum humanum<br />

recombinatum)<br />

3719. NeoRecormon Epoetinum beta<br />

(Erythropoietinum humanum<br />

recombinatum)<br />

3720. NeoRecormon Epoetinum beta<br />

(Erythropoietinum humanum<br />

recombinatum)<br />

3721. NeoRecormon Epoetinum beta<br />

(Erythropoietinum humanum<br />

recombinatum)<br />

3722. NeoRecormon Epoetinum beta<br />

(Erythropoietinum humanum<br />

recombinatum)<br />

3723. NeoRecormon Epoetinum beta<br />

(Erythropoietinum humanum<br />

recombinatum)<br />

3724. NeoRecormon Epoetinum beta<br />

(Erythropoietinum humanum<br />

recombinatum)<br />

3725. NeoRecormon Epoetinum beta<br />

(Erythropoietinum humanum<br />

recombinatum)<br />

3726. NeoRecormon Epoetinum beta<br />

(Erythropoietinum humanum<br />

recombinatum)<br />

3727. NeoRecormon Epoetinum beta<br />

(Erythropoietinum humanum<br />

recombinatum)<br />

Pharmaceutical<br />

form<br />

sol. for inf. 2,3g+3,75g+3,75g+1,5g+<br />

2,4g+2,05g+0,8g+3g+1g+<br />

0,9g+2,05g+4g+1,7g+6g+<br />

0,37g+0,8g+1,35g+2,85g+<br />

1,25g+2,5g+0,62g/1000ml<br />

500ml<br />

Strength Manufacturer<br />

sol. for inf. 4,6g+7,5g+7,5g+3g+4,8g+<br />

4,1g+1,6g+6g+2g+1,8g+4,1g+<br />

8g+3,4g+12g+ 0,37g+1,6g+<br />

2,7g+5,7g+ 2,5g+2,5g+<br />

0,62g/1000ml 500ml<br />

sol. for inj. 500IU (4,15µg)/ 0,3ml<br />

pre-filled syringe N1; N6<br />

sol. for inj. 1000IU (8,3µg)/0,3ml<br />

pre-filled syringe N1; N6<br />

sol. for inj. 2000IU (16,6µg)/ 0,3ml<br />

pre-filled syringe N1; N6<br />

sol. for inj. 3000IU (24,9µg)/ 0,3ml<br />

pre-filled syringe N1; N6<br />

sol. for inj. 5000IU (41,5µg)/ 0,3ml<br />

pre-filled syringe N1; N6<br />

sol. for inj. 10000IU (83µg)/0,6ml<br />

pre-filled syringe N1; N6<br />

sol. for inj. 20000IU (166µg)/0,6ml<br />

pre-filled syringe N1; N6<br />

sol. for inj. 4000IU/ 0,3ml pre-filled<br />

syringe N1;N6<br />

powder and<br />

solvent for<br />

sol.for inj.<br />

60000 IU / two-chamber<br />

cartridge N1;N3<br />

sol. for inj. 6000IU/ 0,3ml pre-filled<br />

syringe N1;N6<br />

Infusia<br />

Infusia<br />

Vetter Pharma/Roche<br />

Diagnostics<br />

Vetter Pharma/<br />

Roche Diagnostics<br />

Vetter Pharma/<br />

Roche Diagnostics<br />

Vetter Pharma/<br />

Roche Diagnostics<br />

Vetter Pharma/<br />

Roche Diagnostics<br />

Vetter Pharma/<br />

Roche Diagnostics<br />

Vetter Pharma/<br />

Roche Diagnostics<br />

Roche Diagnostics<br />

Vetter Pharma-<br />

Vertigung/ Roche<br />

Diagnostics<br />

Roche Diagnostics


EN<br />

284 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

3728. NeoSpect Depreotide trifluoroacetate<br />

corresp. to depreotide<br />

3729. Neosporin eye drops Polymyxinum B+<br />

Neomycinum+<br />

Gramicidinum<br />

Pharmaceutical<br />

form<br />

kit for radio<br />

pharmaceutical<br />

preparation<br />

Strength Manufacturer<br />

47µg vials N1;N5 Isopharma AS<br />

eye drops 5000U+1700U+25U/ml<br />

5ml<br />

3730. Neotigason Acitretinum caps. 10mg<br />

N30<br />

3731. Neotigason Acitretinum caps. 25mg<br />

N30<br />

3732. Neoton 1g flebo Dinatrium creatini phosphas powder and<br />

solvent for sol.<br />

for inj.<br />

3733. Neoton 500 Dinatrium creatini phosphas powder and<br />

solvent for<br />

sol.for inj.<br />

3734. Neovir Natrium 10methylencarboxylate-9-acridon<br />

3735. Nervinum fix Melissae folium+Lupuli strob.+<br />

Lavandulae flos<br />

3736. Nervoheel Acidum phosphoricum D4+<br />

Ignatia D4+ Sepia officinalis<br />

D4 +Psorinum-Nosode D12+<br />

Kalium bromatum D4+Zincum<br />

valerianicum D4<br />

3737. Nervosol Extr.fl.(1:2) ex: Rad.Valerianae+<br />

Herb.Melissae+<br />

Rad.Archangelicae+<br />

Strob.Humuli lupuli+<br />

Flor.Lavandulae<br />

3738. Nervu˛ sistema˛ raminamasis<br />

vaistazˇoliu˛ mišinys<br />

3739. Nervus raminantis vaistazˇoliu˛<br />

mišinys<br />

3740. Nervus raminantis vaistazˇoliu˛<br />

mišinys<br />

3741. Nervus raminantis vaistazˇoliu˛<br />

mišinys<br />

‘Neuro 1’<br />

3742. Nervus raminantis vaistazˇoliu˛<br />

mišinys<br />

‘Neuro 2’<br />

3743. Nervus raminantis vaistazˇoliu˛<br />

mišinys<br />

‘Neuro 3’<br />

1g/vial (bottle of solvent 50ml)<br />

N1; N4<br />

500mg/vial (solvent: Lidocaine<br />

hydrochloride 40mg/4ml<br />

amp.) N6<br />

Glaxo Wellcome<br />

Roche Products<br />

Roche Products<br />

Alfa Wasserman<br />

Alfa Wasserman<br />

sol. for inj. 250mg/2ml Schering<br />

herbal tea 600mg+ 250mg+ 150mg/maišelyje<br />

(1g) N20<br />

tab. 60mg+60mg+60mg+ 60mg+<br />

30mg+30mg<br />

drops 25+25+20+ 15+15(partes)<br />

Ethanolum 50-57% 35g<br />

Species sedativa herbal tea 100g, 50g, 50g(2g×25), 37,5g<br />

(1,5×25); 25g(1g×25)<br />

Menthae piperitae folia+<br />

Menyanthidis trifoliatae folia+<br />

Valerianae rhizomata cum<br />

radicibus+ Humuli lupuli strob.<br />

Menthae piperitae folium +<br />

Menyanthidis folium+<br />

Valerianae radix+Lupuli flos<br />

Lavandulae flos+Passiflorae<br />

herba+Melissae folium+<br />

Menthae piperitae folium<br />

Valerianae radix +Passiflorae<br />

herba+Menthae piperitae<br />

folium<br />

Valerianae radix+Melissae<br />

folium+Menthae piperitae<br />

folium+Lupuli flos<br />

herbal tea 33,3g+33,3g+16,7g+<br />

16,7g/100g 100g; 50g; 50g<br />

(2g×25); 25g (1g×25); 16,8g<br />

(0,7g×24); 24g (1g×24); 36g<br />

(1,5g×24); 48g (2g×24)<br />

herbal tea 33,3g+33,3g+16,7g+<br />

16,7g/100g 30g; 37,5g<br />

(1,5g×25)<br />

herbal tea 27g+36g+ 28g+9g/100g 37,5g<br />

(1,5g×25)<br />

herbal tea 65g+28g+7g/100g 37,5g<br />

(1,5g×25)<br />

herbal tea 59g+25g+8g+8g/100g 37,5g<br />

(1,5g×25)<br />

3744. Neupogen Filgrastimum sol. for inj. 482µg (48MU)/<br />

1,6ml pre-filled syringe N5<br />

Herba Humana<br />

Heel<br />

Herbapol Cracow<br />

P.Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Acorus Calamus<br />

Acorus Calamus<br />

Acorus Calamus<br />

Acorus Calamus<br />

Roche


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 285<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3745. Neupogen Filgrastimum sol. for inj. 100µg (10MU)/<br />

0,5ml pre-filled syringe N5<br />

3746. Neupogen Filgrastimum sol. for inj. 300µg (30MU)/<br />

ml pre-filled syringe N5<br />

Strength Manufacturer<br />

3747. Neupogen syringe 30 MU Filgrastimum sol. for inj. 300µg)/0,5ml pre-filled syringe<br />

N1<br />

3748. Neupogen syringe 48 MU Filgrastimum sol. for inj. 480µg/0,5ml pre-filled syringe<br />

N1<br />

3749. Neuro-3 Valerianae radicis extr. spir.<br />

siccum (Acidum valerenicum)+<br />

Lupuli flos extr.spir.<br />

siccum+Melissae<br />

fol.extr.aq.siccum<br />

3750. Neuro-3 forte Valerianae radicis<br />

extr.spir.siccum (Acidum<br />

valerenicum)+<br />

Lupuli flos extr.spir<br />

siccum+Melissae<br />

fol.extr.aq.siccum<br />

3751. NeuroMax forte Thiaminum+<br />

Pyridoxinum+<br />

Cyanocobalaminum<br />

3752. Neuromed Valerianae radix, Angelicae<br />

radix Melissae folium, Lupuli<br />

strobulus, Lavandulae flos<br />

3753. Neuromed Valerianae rad. + Angelica rad.<br />

+ Melissae herba + Lupuli<br />

strobuli + Levandulae flos<br />

3754. Neuromultivit Thiaminum+ Pyridoxinum+<br />

Cyanocobalaminum<br />

3755. Neurontin<br />

600 mg<br />

3756. Neurontin<br />

800 mg<br />

caps. 188mg (1,5mg)+<br />

30mg+80mg N15<br />

caps. 379mg (3mg)+60mg +161mg<br />

N10<br />

film-coated tab. 100mg+200mg+0,2mg<br />

N30; N100<br />

Roche<br />

Roche<br />

Roche<br />

Roche<br />

Hasco-Lek<br />

Hasco-Lek<br />

Vitabalans<br />

extract (1:2) 50ml Bakteriniai<br />

preparatai<br />

extr. 1000 g Ethanolum ad 2 l<br />

25 ml, 50 ml,<br />

100 ml<br />

film-coated tab. 100mg+ 200mg+ 200µg N20;<br />

N100<br />

Gabapentinum film-coated tab. 600mg<br />

N50; N100<br />

Gabapentinum film-coated tab. 800mg<br />

N50; N100<br />

Bakteriniai<br />

preparatai<br />

Lannacher<br />

Goedecke<br />

Goedecke<br />

3757. Neurontin Gabapentinum caps. 100mg N20; N100 Godecke<br />

3758. Neurontin Gabapentinum caps. 400mg N50; N100 Godecke<br />

3759. Neurontin Gabapentinum caps. 300mg N50; N100 Godecke<br />

3760. Neurorubin Thiaminum+Pyridoxinum+<br />

Cyanocobalaminum<br />

3761. Neurorubine-forte Lactab Thiaminum+ Pyridoxinum+<br />

Cyanocobalaminum<br />

3762. Neurosan Thiaminum +Pyridoxinum +<br />

Cyancobalaminum<br />

3763. Neurosan Thiaminum +Pyridoxinum +<br />

Cyancobalaminum<br />

sol. for inj. 100mg+100mg+1mg/3ml<br />

amp. N5<br />

3764. Neutronorm retard Cimetidinum tab. 350mg<br />

N20<br />

3765. Nexium Esomeprazolum gastro-resistant<br />

tab.<br />

Mepha<br />

film-coated tab. 200mg+ 50mg+1mg N20 Mepha<br />

sol. for inj. 100mg/100mg/1mg Sanitas<br />

caps. 100mg/200mg/200mcg Sanitas<br />

Ebewe<br />

40mg N7; N14; N28 AstraZeneca


EN<br />

286 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3766. Nexium Esomeprazolum gastro-resistant<br />

tab.<br />

3767. Nicerium 30 uno Nicergolinum capsules 30mg N30;N60;<br />

N100<br />

3768. Nicoflex Capsaicinum+<br />

Ol.Lavandulae+<br />

Ethylnicotinum+<br />

Ethylenglycolum salicylicum<br />

cream 7,5mg+50mg+<br />

1g+4,5g/50g 50g<br />

Strength Manufacturer<br />

20mg N7; N14; N28 AstraZeneca<br />

Salutas Pharma<br />

GmbH<br />

Reanal Finechemical<br />

Company<br />

3769. Nicorette Mint Nicotinum chewing gum 2mg N30;N105 Pharmacia & Upjohn<br />

3770. Nicorette Mint Nicotinum chewing gum 4mg N30;N105 Pharmacia & Upjohn<br />

3771. Nicorette Patch Nicotinum transdermal<br />

patch<br />

3772. Nicorette Patch Nicotinum transdermal<br />

patch<br />

3773. Nicorette Patch Nicotinum transdermal<br />

patch<br />

5mg/16 hours N7 Pharmacia & Upjohn<br />

10mg/16 hours N7 Pharmacia & Upjohn<br />

15mg/16 hours N7 Pharmacia & Upjohn<br />

3774. Nicotinell fruit Nicotinum chewing gum 2mg N12;N48 Fertin<br />

3775. Nicotinell fruit Nicotinum chewing gum 4mg N12;N48 Fertin<br />

3776. Nicotinell mint Nicotinum chewing gum 2mg N12;N48 Fertin<br />

3777. Nicotinell mint Nicotinum chewing gum 4mg N12;N48 Fertin<br />

3778. Nicotinell TTS 10 Nicotinum transdermal<br />

paches<br />

3779. Nicotinell TTS 20 Nicotinum transdermal<br />

paches<br />

3780. Nicotinell TTS 30 Nicotinum transdermal<br />

paches<br />

17,5mg/ 10cm 2 N7 Lohmann Therapie-<br />

Systeme<br />

35mg/ 20cm 2 N7 Lohmann Therapie-<br />

Systeme<br />

52,5mg/ 30cm 2 N7 Lohmann Therapie-<br />

Systeme<br />

3781. Nifedeks Nifedipinum tab. 10mg N30 Grindeks<br />

3782. Nifedipin 5 Stada Nifedipinum caps. 5mg N20; N50; N100 Stada<br />

3783. Nifedipin K 10 Stada Nifedipinum caps. 10mg N20; N50; N100 Stada<br />

3784. Nifedipin OD Nycomed Nifedipinum modified-release<br />

tab.<br />

3785. Nifedipin T20 Stada retard Nifedipinum modified-release<br />

tab.<br />

40mg<br />

N30<br />

3786. Nifedipine Nifedipinum coated tab. 10mg<br />

N50<br />

3787. Nifluril Acidum niflumicum cream 3g/100g<br />

60g<br />

3788. Night Rest (Ramus miegas) Extr.Valerianae sicc. (4:1)+Extr.<br />

Humuli lupuli sicc.(5:1)+<br />

Extr.Mellisae sicc.+ Thiaminum<br />

3789. Nikotino rūgšties 1 % tirpalas<br />

injekcijoms<br />

3790. Nikotino rūgšties 1 % tirpalas<br />

injekcijoms<br />

20mg N20; N100 Stada<br />

caps., soft 100mg+30mg+40mg+ 2mg<br />

N40<br />

Siegfried Pharma<br />

Polfa Grodzisk<br />

UPSA<br />

Arco-Chemie<br />

Acidum nicotinicum sol. for inj. 10mg/ml amp. N10 Bakteriniai<br />

preparatai<br />

Acidum nicotinicum sol. for inj. 10mg/ml 1ml amp. N10 Endokrininiai<br />

preparatai


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 287<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3791. Nimbex Cisatracurii besilas sol. for inj. 2mg/ml 2,5ml; 5ml; 25ml Glaxo Wellcome<br />

3792. Nimbex forte Cisatracurii besilas sol. for inj. 5mg/ml 30ml Glaxo Wellcome<br />

3793. Nimesil Nimesulidum granulate for<br />

oral susp.<br />

100mg/2g sachet<br />

N30; N15; N9<br />

3794. Nipas Acidum acetylsalicylicum tab. 32 mg N100 Liuks<br />

3795. Nipruss Natrii nitroprussidum powder for<br />

sol.for inf.<br />

3796. NiQuitin CQ 14mg Nicotinum Trans-dermal<br />

patch<br />

3797. NiQuitin CQ 21mg Nicotinum transdermal<br />

patch<br />

3798. NiQuitin CQ 7mg Nicotinum transdermal<br />

patch<br />

3799. Nisita Nasensalbe Natrii chloridum+ Natrii<br />

hydrocarbonas<br />

Laboratori Guidotti<br />

52,75mg/ amp. N5 Schwarz Pharma<br />

78mg/15cm 2 (14mg/24h) N7;<br />

N14<br />

114mg/22cm 2 (21mg/24h)<br />

N7;N14<br />

36mg/7cm 2 (7mg/24h) N7;<br />

N14<br />

Unipack/<br />

Alza Corporation<br />

Unipack/<br />

Alza Corporation<br />

Unipack/<br />

Alza Corporation<br />

nasal oint-ment 28mg+ 72mg/g 20g Engelhard<br />

3800. Nistatino tablete˙s Nystatinum tab. 500000 VV N20 Liuks<br />

3801. Nitrangin Pump Spray Glyceroli trinitras + Ethanolum<br />

99,7%<br />

3802. Nitrazepam Alpharma Tablets<br />

5mg<br />

3803. Nitrazepamo<br />

5 mg tablete˙s<br />

3804. Nitrazepamo<br />

10 mg tablete˙s<br />

3805. Nitrendipino<br />

20 mg tablete˙s<br />

spray 0,4mg+15,1mg/dose 300doses Isis Pharma<br />

Nitrazepamum tab. 5mg N20; N30 Alpharma<br />

Nitrazepamum tab. 5 mg N10; N20, N30 Liuks<br />

Nitrazepamum tab. 10 mg N10; N20; N30 Liuks<br />

Nitrendipinum tab. 20 mg N20; N30 Liuks<br />

3806. Nitrepress 10 Nitrendipinum tab. 10mg N20;N50; N100 Salutas<br />

3807. Nitrepress 20 Nitrendipinum tab. 20mg N20;N50 Salutas<br />

3808. Nit-Ret Slovakofarma Glyceroli trinitras slow-release<br />

tab.<br />

3809. Nitro Mack Ampoules Glyceroli trinitras conc. for sol.for<br />

inf.<br />

3810. Nitro Mack Retard<br />

2,5 mg<br />

Glyceroli trinitras sustainedrelease<br />

caps.,<br />

hard<br />

3811. Nitro Mack Retard 5 mg Glyceroli trinitras sustainedrelease<br />

caps.,<br />

hard<br />

2,5mg<br />

N50<br />

5mg/5ml<br />

amp. N10<br />

2,5mg N50 Mack<br />

5mg<br />

N100<br />

3812. Nitro Pohl infus. Glyceroli trinitras sol. for inf. 1mg/ml 5ml; 10ml; 25ml<br />

amp.; 50ml vials<br />

3813. Nitrocine Glyceroli trinitras sol. for inf. 10mg/10ml N10×10ml amp.;<br />

N1×50ml; N5×50ml.vial<br />

3814. Nitroderm TTS 10 Glyceroli trinitras Trans-dermal<br />

patch<br />

Slovakofarma<br />

Pharma Hameln<br />

Mack<br />

Pohl-Boskamp<br />

Schwarz Pharma<br />

50mg/20cm 2 N10 Novartis Pharma<br />

Stein


EN<br />

288 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3815. Nitroderm TTS 5 Glyceroli trinitras Trans-dermal<br />

patch<br />

Strength Manufacturer<br />

25mg/10cm 2 N10 Novartis Pharma<br />

Stein<br />

3816. Nitrofungin Chlornitrophe-nolum sol. 250mg/25ml 25ml IVAX-CR<br />

3817. Nitrofurazono 0,2% tepalas Nitrofuralum ointment 2mg/g 30g KMA vaistine˙<br />

3818. Nitroglicerino tablete˙s Glycerili trinytras tab. 0,5 mg N20; N30; N50 Liuks<br />

3819. Nitroglycerin Nycomed<br />

0,5 mg<br />

3820. Nitroglycerin Nycomed<br />

0,25 mg<br />

Glyceroli trinitras sublingual tab. 0,5mg N25 Nycomed Danmark<br />

Glyceroli trinitras sublingual tab. 0,25mg N25 Nycomed Danmark<br />

3821. Nitroglyceri-num 0,5 Glyceroli trinitras tab. 0,5mg<br />

N20<br />

3822. Nitrolingual-Spray Glyceroli trinitras spray 0,4mg/dose 12,2ml Pohl-Boskamp<br />

3823. Nitromint Glyceroli trinitras (Nitroglycerinum)<br />

Argon<br />

aerosol 400µg/ dose 180 doses Egis<br />

3824. Nitromint 2,6mg retard tablets Glyceroli trinitras tab. 2,6mg N60 Egis<br />

3825. Nitrong Forte Glyceroli trinitras prolon- ged<br />

release tab.<br />

3826. Nitrosorbid Isosorbidi dinitras tab. 20mg<br />

N100<br />

3827. Nittyfor Permethrin cream with<br />

conditioner<br />

6,5mg N25;N100 KRKA<br />

Orion<br />

1% 120ml Biogal<br />

Pharmaceutical<br />

Works Ltd.<br />

3828. Nittyfor 0,5 % Permethrinum sol. 5g/1 000ml 60ml Biogal<br />

3829. Nix creme rinse Permethrinum cream 1% 10mg/g 59ml Glaxo Wellcome<br />

3830. Nix dermal cream Permethrinum cream 5% 50mg/g<br />

30g<br />

Glaxo Wellcome<br />

3831. Nizoral Ketoconazolum tab. 200mg N10; N30 Janssen-Cilag<br />

3832. Nizoral cream Ketoconazolum cream 20mg/g 15g;30g Janssen<br />

Pharmaceutica<br />

3833. Nizoral šampūnas nuo<br />

pleiskanu˛<br />

Ketoconazolum shampoo 20mg/g 25ml; 60ml; 100ml Janssen<br />

Pharmaceutica<br />

3834. Nok Cream shampoo Permethrinum cream-shampoo 1mg/ml 100ml CTS<br />

3835. Nolicin Norfloxacinum film-coated tab. 400mg<br />

N20<br />

3836. Noliprel Perindoprilum<br />

tretbutylaminum+<br />

Indapamidum<br />

3837. Noliprel forte Perindoprilum<br />

tretbutylaminum+<br />

Indapamidum<br />

3838. Non-Ovlon Ethinylestradiolum+<br />

Norethisteronum<br />

scored tab. 2mg+ 0,625mg<br />

N30<br />

KRKA<br />

Servier<br />

tab. 4mg+ 1,25mg N30 Servier<br />

sugar-coated<br />

tab.<br />

0,05mg+1mg N21 Jenapharm


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 289<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3839. Nootropil Piracetamum sol. for inf. 12g/60ml<br />

N1<br />

3840. Nootropil Piracetamum sol. for inj. 3g/15ml<br />

N4; N15<br />

Strength Manufacturer<br />

UCB S.A.<br />

Pharmaceutical<br />

Sector<br />

UCB S.A.<br />

Pharmaceutical<br />

Sector<br />

3841. Nootropil Piracetamum oral sol. 33,33g/100ml 125ml UCB S.A.<br />

Pharmaceutical<br />

Sector<br />

3842. Nootropil Piracetamum film-coated tab. 1200mg<br />

N30; N60<br />

3843. Nootropil Piracetamum film-coated tab. 800mg<br />

N30; N60; N90<br />

3844. Nootropil Piracetamum sol. for inj. 1000mg/5ml N12 Jelfa<br />

UCB S.A<br />

Pharmaceutical<br />

Sector<br />

UCB S.A.<br />

Pharmaceutical<br />

Sector<br />

3845. Nootropil Piracetamum caps. 400mg N60 Pliva Krakow<br />

3846. Norbactin Norfloxacinum film-coated tab. 400mg<br />

N10; N100<br />

3847. Norcolut Norethisteronum tab. 5mg<br />

N20<br />

3848. Norditropin Nordi-Let<br />

10mg/1,5ml<br />

Somatropinum sol.for inj. 10mg/1,5ml 1,5ml pre-filled<br />

pen N1<br />

3849. Norditropin PenSet 12 Somatropinum powder and<br />

solvent for sol.<br />

for inj.<br />

3850. Norditropin PenSet 24 Somatropinum powder and<br />

solvent for sol.<br />

for inj.<br />

12 IU (4mg)/<br />

vial+ 2ml cartridge of solv.<br />

(Benzyl alkohol<br />

20,25mg/2ml)+ N1<br />

24 IU (8mg)/ vial+2ml<br />

cartridge of solv. (Benzyl<br />

alkohol 20,25mg/2ml)+ N1<br />

3851. Norditropin Simplexx Somatropinum sol. for inj. 10mg/1,5ml cartridge for use<br />

in NordiPen 10 N1<br />

3852. Norfloxacin-ratiopharm<br />

400 mg<br />

Ranbaxy<br />

Gedeon Richter<br />

Novo Nordisk A/S<br />

Novo Nordisk<br />

Novo Nordisk<br />

Novo Nordisk<br />

Norfloxacinum film coated-tab. 400mg N20 Merckle<br />

3853. Noritren Nortriptylinum tab. 50mg N100 Lundbeck<br />

3854. Noritren Nortriptylinum tab. 10mg N100 Lundbeck<br />

3855. Noritren Nortriptylinum tab. 25mg N100 Lundbeck<br />

3856. NorLevo Levonorgestrelum tab. 0,75mg<br />

N2<br />

3857. Normodipine 10 mg Amlodipinum tab. 10mg<br />

N30<br />

3858. Normodipine 5 mg Amlodipinum tab. 5mg<br />

N30<br />

3859. Norvasc 10 mg Amlodipinum tab. 10mg N30 Pfizer<br />

3860. Norvasc 5 mg Amlodipinum tab. 5mg N30 Pfizer<br />

3861. Norvir Ritonavirum oral sol. 80mg/ml (Ethanolum 43%)<br />

90ml<br />

L.C.O. Sante<br />

Gedeon Richter<br />

Gedeon Richter<br />

Abbott


EN<br />

290 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3862. Norvir 100mg soft capsules Ritonavirum caps.,soft 100mg N4×84 Abbott<br />

3863. No-Spa Drotaverinum tab. 40mg<br />

N20; N100<br />

Chinoin<br />

3864. No-Spa Drotaverinum sol. for inj. 40mg/2ml amp. N25 Chinoin<br />

3865. No-spa forte Drotaverinum tab. 80mg N20 Chinoin<br />

3866. No-spa forte Drotaverinum sol. for inj. 80mg/4ml amp. N5 Chinoin<br />

3867. Nošpanas Drotaverini hydrochloridum sol. for. inj. 4 % Endokrininiai<br />

preparatai<br />

3868. Nošpanas 40 Drotaverinum tab. 40mg N20; N50; N100 Endokrininiai<br />

preparatai<br />

3869. Nošpanas 80 Drotaverinum tablets 80mg N20; N50; N100 Endokrininiai<br />

preparatai AB<br />

3870. Notta compos. oral drops,<br />

solution<br />

(Ethanolum<br />

43% w/v)<br />

3871. Nova T Varine˙ vielele˙ su sidabrine<br />

šerdimi<br />

3872. Novalgin Propiphenazone+<br />

Paracetamol+ Caffeine<br />

intrauterine<br />

device<br />

3873. Novantrone Mitoxantronum concentrate for<br />

sol. for inf.<br />

20ml;50ml; 100ml Richard Bittner<br />

GmbH<br />

200 mm 2 Leiras<br />

tablets 0,2g+0,2g+ 0,05g N6;N12;<br />

N30;N50; N100;N120<br />

SC ‘Concern Stirol’<br />

2mg/ml, 10ml;20ml vial Lederle-Parenterals<br />

3874. Novitropan Oxybutyninum tab. 5mg N30 CTS<br />

3875. Novofem Estradiolum+<br />

Norethisteronum; Estradiolum<br />

3876. Novokaino<br />

0,25 % tirpalas injekcijoms<br />

3877. Novokaino<br />

1 % tirpalas injekcijoms<br />

3878. Novokaino 0,25 % tirpalas<br />

injekcijoms<br />

3879. Novokaino 0,25 % tirpalas<br />

injekcijoms<br />

3880. Novokaino 0,5 % tirpalas<br />

injekcijoms<br />

3881. Novokaino 0,5 % tirpalas<br />

injekcijoms<br />

3882. Novokaino 0,5 % tirpalas<br />

injekcijoms<br />

film-coated<br />

tablet<br />

white tab.: 1mg+1mg; red<br />

tab.:1mg N28<br />

Novo Nordisk A/S<br />

Procainum sol. for inj. 10mg/2ml amp. N10 Endokrininiai<br />

preparatai<br />

Procainum sol. for inj. 1g/100ml 100ml Ilsanta<br />

Procainum sol. for inj. 250mg/<br />

100ml 100ml<br />

Procainum sol. for inj. 12,5mg/5ml amp.<br />

N10<br />

Procainum sol. for inj. 5mg/ml<br />

1ml; 2ml; 5ml; 10ml amp. N5;<br />

N10<br />

Procainum sol. for inj. 25mg/5ml amp.<br />

N10<br />

Procainum sol. for inj. 500mg/<br />

100ml 100ml<br />

Ilsanta<br />

Endokrininiai<br />

preparatai<br />

Sanitas<br />

Endokrininiai<br />

preparatai<br />

3883. Novokains 1 % Procainum sol.for inf. 10mg/ml 250ml Grindeks<br />

3884. Novokains 2 % Procainum sol.for inf. 20mg/ml 250ml Grindeks<br />

3885. Novokains 0,25 % Procainum sol.for inf. 2,5mg/ml 250ml Grindeks<br />

3886. Novokains 0,5 % Procainum sol.for inf. 5mg/ml 250ml Grindeks<br />

Ilsanta


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 291<br />

No. Commercial name General name<br />

3887. NovoMix 30 FlexPen Insulin aspart<br />

(r-DNA)<br />

3888. NovoMix 30 Penfill Insulin aspart<br />

(r-DNA)<br />

Pharmaceutical<br />

form<br />

susp.for inj. 100 U/ml<br />

pre-filled syringe 3ml N5<br />

3889. NovoNorm Repaglinidum tab. 0,5mg<br />

N30; N90<br />

3890. NovoNorm Repaglinidum tab. 1mg<br />

N30; N90<br />

Strength Manufacturer<br />

Novo Nordisk<br />

susp.for inj. 100 U/ml 3ml Penfill amp. N5 Novo Nordisk<br />

Boehringer<br />

Ingelheim<br />

Boehringer<br />

Ingelheim<br />

3891. NovoNorm Repaglinidum tab. 2mg N30; N90 Boehringer<br />

Ingelheim/ Novo<br />

Nordisk<br />

3892. NovoRapid FlexPen Insulin aspart<br />

(r-DNA)<br />

sol. for inj. 100 U/ml<br />

pre-filled syringe 3ml N5<br />

3893. NovoRapid NovoLet Insulin aspart sol. for inj. 100 U/ml 3ml pre-filled<br />

syringe N5<br />

3894. NovoRapid Penfill Insulin aspart sol. for inj. 100 U/ml 3ml penfill<br />

cartridges N5<br />

3895. NovoSeven Human recombinant<br />

coagulation factor FVIIa<br />

3896. NovoSeven Human recombinant<br />

coagulation factor FVIIa<br />

3897. NovoSeven Human recombinant<br />

coagulation factor FVIIa<br />

3898. Novynette Desogestrelum+<br />

Ethinylestradiolum<br />

powder and<br />

solvent for sol.<br />

for i.v.inj.<br />

powder and<br />

solvent for sol.<br />

for i.v.inj.<br />

powder and<br />

solvent for sol.<br />

for i.v. inj.<br />

3899. Nozepams 10mg Oxazepamum tab. 10mg<br />

N50<br />

3900. NPH Iletin II Isophanum insulinum susp. for inj. 100IU/ml<br />

N1 10ml<br />

3901. Nurofen Ibuprofenum tab. 200mg<br />

N12; N24<br />

3902. Nutralipid MCT 20 % Emulsion Sojae oleum fractionatum+<br />

Cocos oleum fractionatum+<br />

Lecithinum ex ovo<br />

fractionatum+ Glycerolum<br />

85%<br />

3903. Nutrison Proteins+Carbohydrates+Fats+<br />

Sodium+Minerals+Vit.A+<br />

Vit.D+Vit.E (alpha-TE)+ Vit.E +<br />

Vit.K +Thiamin+ Riboflavin +<br />

Niacin+Niacin-NE+<br />

Pantothenate+Pyridoxine+<br />

Folate+Cyanocobalamin+<br />

Ascorbic acid+ Biotin+Choline<br />

120KIU (2,4mg) and 4,3ml<br />

N1+N1<br />

60KIU (1,2mg) and 2,2ml N1+<br />

N1<br />

240KIU (4,8mg) and 8,5ml<br />

N1+N1<br />

Novo Nordisk<br />

Novo Nordisk<br />

Novo Nordisk<br />

Novo Nordisk<br />

Novo Nordisk<br />

Novo Nordisk<br />

film-coated tab. 0,15mg+ 0,02mg N21; N63 Gedeon Richter<br />

fatty emul-sion<br />

for inf.<br />

10g+10g+ 1,2g+<br />

2,25ml/100ml 100ml; 250ml;<br />

500ml<br />

powder 18,75g+ 57,5g+18,3g+ 0,38g+<br />

2,5g+350µg+ 2,35µg+ 4,7mg+<br />

6,3mg+ 16,3µg+ 0,35mg+<br />

0,4mg+ 4,7mg+9mg+2,3mg+<br />

0,47mg+ 95µg+1,5µg+ 21mg+<br />

70µg+93mg/100g;<br />

430g=2000kcal=8400kJ<br />

OlainFarm<br />

Eli Lilly<br />

Boots<br />

ICN Czech Republic<br />

Nutricia


EN<br />

292 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

3904. Nutrison Paediatric Standard Proteins+Carbohydrates+Fats+<br />

Sodium+Minerals+ Vit.A+<br />

Vit.D+Vit.E (alpha-TE)+Vit.E +<br />

Vit.K+ Thiamin+ Riboflavin+<br />

Niacin+ Niacin-NE+<br />

Pantothenate+Pyridoxine+<br />

Folate+Cyanocobalamin+<br />

Biotin+Vit.C+Carnitine+<br />

Choline<br />

3905. Nux vomica-Homaccord Nux vomica D2+ Nux vomica<br />

D10 +Nux vomica D15 +Nux<br />

vomica D30 +Nux vomica<br />

D200+Nux vomica D1000+<br />

Bryonia cretica D2+ Bryonia<br />

cretica D6+ Bryonia cretica<br />

D10+Bryonia cretica D15+<br />

Bryonia cretica D30+ Bryonia<br />

cretica D200+ Bryonia cretica<br />

D1000+ Lycopodium<br />

clavatum. . .<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

liquid 2,75g+12,23g+4,5g+ 53mg+<br />

0,42g+46,7µg+ 0,83µg+<br />

0,6mg+0,81mg+ 1,3µg+67µg+<br />

87µg+ 0,43mg+ 1,07mg+<br />

0,33mg+87µg+10,7µg+<br />

0,17µg+4,2µg+4mg+2mg+<br />

10mg/100ml; 200ml<br />

1ml=1kcal<br />

drops 0,2g+0,2g+ 0,2g+0,2g+ 0,2g+<br />

0,2g+ 0,2g+0,2g+ 0,2g+0,2g+<br />

0,2g+0,2g+ 0,2g+0,3g/ 100g<br />

(Ethanolum 35 tūrio %) buteliukai-lašintuvai<br />

30ml; 100ml<br />

Nutricia<br />

3906. Nycoflox Fluoxetinum caps. 20mg N30; N60; N100 Nycomed SEFA<br />

3907. Nycopirin Acidum acetylsalicylicum+<br />

Magnesii oxidum<br />

3908. Nyolol 0,25 % Timololum eye drops 2,5mg/ml<br />

3ml<br />

3909. Nyolol 0,5 % Timololum eye drops 5mg/ml<br />

3ml<br />

Heel<br />

tab. 500mg+ 70mg N30; N100 Nycomed DAK/<br />

Nycomed SEFA<br />

Lab. Faure, Groupe<br />

Ciba Vision<br />

Lab. Faure, Groupe<br />

Ciba Vision<br />

3910. Nyolol Gel Timololum eye gel 1mg/ml 5ml Ciba Vision<br />

3911. Nystatin Nystatinum coated tab. 500 000 IU N16 Pliva Krakow<br />

3912. Nystatin<br />

500 000 IU<br />

Nystatinum tab. 100mg (5000UI/mg) N20 Balkanpharma-<br />

Razgrad<br />

3913. Nystatini ung. Nystatinum ointment 100000 UI/g — 15g, 25g, 30g Liuks<br />

3914. Nystatinum 0,25g supp. Nystatinum supp. 0,25g N10 Liuks<br />

3915. Nystatinum 0,5g supp. Nystatinum supp. 0,5g N10<br />

3916. Nytol Diphenhydraminum caplets 25mg<br />

N16<br />

3917. Nytol Natural Extr.Valerianae sicc. (1:4) caplets 100mg N8;N28;N56 Custom<br />

3918. Nytol One-a-night Diphenhydraminum tab. 50mg<br />

N16<br />

3919. Obsidan Propranololum tab. 40mg<br />

N60<br />

3920. Obsidan Propranololum sol. for inj. 1mg/ml<br />

5ml amp.N10<br />

3921. Ocid Omeprazolum caps. 20mg N10 Cadila<br />

3922. Octanativ-M<br />

1000 IU<br />

3923. Octanativ-M<br />

250 IU<br />

Reedco/ Wrafton<br />

Laboratories<br />

Stafford-Miller<br />

ISIS Pharma<br />

(Schwarz Pharma)<br />

ISIS Pharma<br />

(Schwarz Pharma)<br />

Coagulation factor VIII powder for inj. 1000IU Pharmacia AB<br />

Coagulation factor VIII powder for inj. 250IU Pharmacia AB<br />

3924. Octanativ-M 500 IU Coagulation factor VIII powder for inj. 500IU Pharmacia AB


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 293<br />

No. Commercial name General name<br />

3925. Octenisept Octenidini dihydrochloridum+<br />

2-Phenoxyethanolum<br />

Pharmaceutical<br />

form<br />

sol.for topical<br />

use<br />

Strength Manufacturer<br />

100mg+ 2g/100g 50ml;<br />

250ml;1000ml<br />

3926. Octilia Tetryzolinum eye drops 50mg/100ml 8ml S.I.F.I.<br />

3927. Octostim Desmopressinum inj. 15µg/ml N5 Ferring<br />

3928. Oculoheel Euphrasia officinalis D5+<br />

Cochlearia officinalis D5+<br />

Jaborandi D5+ Echinacea<br />

angustifolia D5<br />

eye drops 110,7mg+ 110,7mg+<br />

110,7mg+ 110,7mg/ 0,45ml<br />

N15; N20<br />

Schulke & Mayr<br />

3929. Odeston Hymecromonum tab. 200mg N50 Polfa Pabianice<br />

3930. Oesclim 25 µg/24 h Estradiolum transdermal<br />

patch<br />

3931. Oesclim 50 µg/24 h Estradiolum transdermal<br />

patch<br />

3932. Oesclim 75 µg/24 h Estradiolum transdermal<br />

patch<br />

3933. Oesclim 37,5 µg/24 h Estradiolum transdermal<br />

patch<br />

3934. Oestrofeminal 0,3 mg Conjugated estrogens caps. 0,3mg<br />

N21<br />

3935. Oestrofeminal 0,6 mg Conjugated estrogens caps. 0,6mg<br />

N21<br />

3936. Oestrofeminal 1,25 mg Conjugated estrogens caps. 1,25mg<br />

N21<br />

Heel<br />

25µg/24h (5mg/ 11cm 2 ) N8 Laboratoires<br />

Fournier<br />

50µg/24h (10mg/ 22cm 2 ) N8 Laboratoires<br />

Fournier<br />

75µg/24h (15mg/ 33cm 2 ) N8 Laboratoires<br />

Fournier<br />

37,5µg/24h (7,5mg/ 16,5cm 2 )<br />

N8<br />

3937. Ofloxin 200 Ofloxacinum film-coated tab. 200mg N10 Lečiva<br />

3938. Oframax Ceftriaxonum powder and<br />

solvent for sol.<br />

for inj.<br />

3939. Oframax Ceftriaxonum powder and<br />

solvent for sol.<br />

for inj.<br />

1g<br />

N1 10ml<br />

250mg<br />

N1 10ml<br />

Laboratoires<br />

Fournier<br />

Mack<br />

Mack<br />

Mack<br />

Ranbaxy<br />

Ranbaxy<br />

3940. Oftagel Carbomerum eye gel 2,5mg/g 10g Ursapharm<br />

3941. Oftalmelis Melum eye drops 300mg/ml 5ml Korio laboratorija<br />

3942. Oftalmelis Melum eye drops 200mg/ml 5ml Korio laboratorija<br />

3943. Oftan A-Pant Retinoli palmitas+<br />

Dexpanthenolum<br />

3944. Oftan Catachrom Cytochromum C +<br />

Adenosinum+ Nicotinamidum<br />

eye ointment 20UI+ 20mg/g 3,5g Apoteket/ Santen<br />

eye drops,<br />

solution<br />

0,675mg+ 2mg+20mg/ml<br />

10ml<br />

3945. Oftan Dexa Dexamethasonum eye drops 1mg/ml 5ml Santen<br />

3946. Oftan Dexa-Chlora Dexamethasonum+<br />

Chloramphenicolum<br />

3947. Oftan Dexa-Chlora Dexamethasonum+<br />

Chloramphenicolum<br />

3948. Oftan IDU 0,1 % Idoxuridinum eye drops, sol. 1mg/ml<br />

10ml<br />

Santen<br />

eye ointment 1mg+ 2mg/g 3,5g Apoteket/ Santen<br />

eye drops,sol. 1mg+ 2mg/ml 10ml Santen<br />

3949. Oftan Timolol Timololum eye drops, sol. 2,5mg/ml 5ml Santen<br />

Santen


EN<br />

294 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

3950. Oftan Timolol Timololum eye drops,sol. 5mg/ml 5ml Santen<br />

3951. Oftensin 0,25% Timololum eye drops 2,5mg/ml<br />

5ml<br />

Polpharma<br />

3952. Oftensin 0,5% Timololum eye drops 5mg/ml 5ml Polpharma<br />

3953. Oguvit (Oguvitas) Extr. fruct. Vaccinii myrtillus<br />

sicc.+ Extr. Euphrasiae<br />

officinalis+ Retinoli palmitas+<br />

Betacarotenum+Thiamini<br />

nitras+ Riboflavinum+Ac.<br />

ascorbicum+ Rutosidum+ DL-<br />

Methioninum+<br />

L-Cysteinum<br />

3954. Oilatum Plus Paraffinum perilquidum+<br />

Benzalkonii chloridum +<br />

Triclosanum<br />

caps. 60mg+ 20mg+ 1,08mg+<br />

10mg+ 1,5mg+ 1,7mg+<br />

60mg+ 200mg+ 7mg+20mg<br />

N40<br />

liq. 52,5%+6%+2%<br />

500ml<br />

Arco-Chemie<br />

Stiefel Laboratories<br />

3955. Okacin Lomefloxacinum eye drops 3mg/ml 5ml Ciba Vision<br />

3956. Oksazepamo<br />

10 mg tablete˙s<br />

3957. Oksitocinas 5 TV injekciju˛<br />

tirpalas/Oxytocin 5 IU<br />

injection<br />

Oxazepamum tab. 10 mg N20; N30, N50 Liuks<br />

Oxytocinum solution for<br />

injection<br />

5 IU/ml N10;N100 amp. Pharmamed<br />

Parenterals Ltd.,<br />

Malta/Lietuvos,<br />

Islandijos ir Švedijos<br />

i˛mone˙ UAB ‘Ilsanta’,<br />

Lietuva<br />

3958. Olbas Inhaler augal. inhalation oil 700mg G.R.Lane Health<br />

Products Ltd.<br />

3959. Olbas Oil augal. inhalation<br />

solution<br />

3960. Oleum Jecoris Perlen Retinolum+Cholecalciferolum+<br />

Jecoris aselii oleum<br />

caps.,soft 3 750 UI+<br />

375 UI+<br />

37,5mg N50<br />

10ml;28ml G.R.Lane Health<br />

Products Ltd.<br />

Balkanpharma-<br />

Troyan<br />

3961. Oleum Ricini Ricini oleum oral liq. 30g;100g Phytopharm Kle˛ka<br />

3962. Olfen — 100 Rectocaps Diclofenacum rectal caps. 100mg<br />

N5<br />

3963. Olfen — 100 SR Depocaps Diclofenacum prolongedrelease<br />

caps.<br />

100mg<br />

N10; N20<br />

3964. Olfen — 25 Lactab Diclofenacum film-coated tab. 25mg<br />

N30<br />

3965. Olfen — 50 Lactab Diclofenacum film-coated tab. 50mg<br />

N20<br />

3966. Olfen — 50 Rectocaps Diclofenacum rectal caps. 50mg<br />

N10<br />

3967. Olfen — 75 Diclofenacum+ Lidocainum sol. for inj. 75mg+20mg/2ml amp. N5 Mepha<br />

3968. Olfen — 75 SR Depotabs Diclofenacum natricum sustainedrelease<br />

tab.<br />

3969. Olfen Gel Diclofenacum gel 10mg/g<br />

20g; 50g<br />

Mepha<br />

Mepha<br />

Mepha<br />

Mepha<br />

Mepha<br />

75mg N10,N30 Mepha<br />

3970. Olfen Roll-on Diclofenacum roll-on gel 10mg/g 50g Mepha<br />

Mepha


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 295<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3971. Olicard 40mg retard Isosorbidi mononitras sustainedrelease<br />

caps.,<br />

hard<br />

3972. Olicard 60mg retard Isosorbidi mononitras sustainedrelease<br />

caps.,<br />

hard<br />

3973. Olimetinum in capsulis<br />

0,5 g<br />

Menthae piperitae oleum+<br />

Terpentini oleum+Acorus<br />

Calamus oleum+ Olivae<br />

oleum+ Sulfur depuratum<br />

40mg<br />

N20; N50; N100<br />

60mg<br />

N20; N50; N100<br />

caps. 8,5mg+ 17,05mg+ 12,5mg+<br />

460,25mg+ 1,7mg N12<br />

Strength Manufacturer<br />

Eurand/<br />

Solvay<br />

Pharmaceuticals<br />

Eurand/<br />

Solvay<br />

Pharmaceuticals<br />

Nizˇfarm<br />

3974. Olynth 0,05 % Xylometazolinum metered spray 50mg/ml 10ml Parke-Davis<br />

3975. Olynth 0,05 % Xylometazolinum nasal drops, sol. 50mg/ml 10ml bottle Parke-Davis<br />

3976. Olynth 0,1 % Xylometazolinum nasal drops, sol. 100mg/ml 10ml bottle Parke-Davis<br />

3977. Olynth 0,1 % Xylometazolinum metered spray 100mg/ml 10ml Parke-Davis<br />

3978. Omedren-L 250 Testosteronum sol. for inj. 250mg/ml 1ml amp.<br />

N5<br />

3979. Omegaven Highly refined fish oil emulsion 10g/100ml 10×50ml;<br />

10×100ml<br />

3980. Omep Omeprazolum gastro-resistant<br />

caps.<br />

3981. Omep 20 tab. Omeprazolum gastro-resistant<br />

tab.<br />

3982. Omeprazole Omeprazolum gastro-resistant<br />

capsule<br />

3983. Omeprazolio<br />

20 mg tablete˙s<br />

20mg N15;N30;N60 GEA<br />

Endokrininiai<br />

preparatai<br />

Fresenius Kabi<br />

Deutschland GmbH<br />

20mg N7;N15 Salutas Pharma<br />

GmbH<br />

20mg N14;N28;N30 Balkanpharma-<br />

Dupnitza AD<br />

Omeprazolum tab. 20 mg N10; N30 Liuks<br />

3984. Omeprazol-ratiopharm NT Omeprazolum gastro -resistant<br />

caps.<br />

3985. Omeprazols 20mg/Omeprazolum<br />

in capsulis<br />

20mg<br />

N15; N30<br />

Omeprazolum caps. 20mg<br />

N30<br />

Merckle<br />

OlainFarm<br />

3986. Omeprosan Omeprazolum caps. 20mg Sanitas<br />

3987. Omnadren Testosteroni propionas+<br />

Testosteroni phenyl propionas<br />

+Testosteroni isocaproas+<br />

Testosteroni decanoas<br />

3988. Omnic Tamsulosinum modified-release<br />

caps.<br />

sol. for inj. ol. 30mg+60mg+<br />

60mg+<br />

100mg/ml<br />

N5<br />

Jelfa<br />

0,4mg N30; N10 Yamanouchi Europe<br />

3989. Omnipaque 180 mg I/ml Iohexolum (Iodum) sol. for inj. 388mg (180mg)/ml 10ml glass<br />

vials and polypropylene bottles<br />

N10<br />

3990. Omnipaque 240 mg I/ml Iohexolum (Iodum) sol. for inj. 518mg/ml (240mg I/ml)<br />

10ml,20ml, 50ml glass vials<br />

and polypropylene bottles<br />

3991. Omnipaque 300 mg I/ml Iohexolum (Iodum) sol. for inj. 647mg/ml (300mg I/ml)<br />

10ml,20ml, 50ml,100ml,<br />

200ml,500ml glass vials;10ml,<br />

20ml,40ml, 50ml polypropylene<br />

bottles<br />

Nycomed Imaging/<br />

Nycomed Ireland<br />

Nycomed Imaging/<br />

Nycomed Ireland<br />

Nycomed Imaging/<br />

Nycomed Ireland


EN<br />

296 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

3992. Omnipaque 350 mg I/ml Iohexolum (Iodum) sol. for inj. 755mg/ml (350mg I/ml)<br />

20ml,50ml,<br />

100ml,200ml,500ml glass<br />

vials; 50ml polypropylene<br />

bottles<br />

3993. Omniscan Gadodiamidum sol. for inj. 0,5mmol (287mg)/ml 5ml;<br />

10ml; 15ml; 20ml vials N10<br />

Strength Manufacturer<br />

3994. One-Alpha Alfacalcidolum caps. 0,5µg N30 Leo<br />

3995. One-Alpha Alfacalcidolum sol. for inj. 2µg/ml 0,5ml; 1ml amp. N10 Leo<br />

3996. One-Alpha Alfacalcidolum caps. 0,25µg N30;N100 Leo<br />

3997. One-Alpha Alfacalcidolum caps. 1µg N10;N100 Leo<br />

3998. Onkotrone Mitoxantronum sol. for inj. 2mg/ml<br />

10ml bottle<br />

3999. Onkotrone Mitoxantronum sol. for inj. 2mg/ml<br />

5ml bottle<br />

Nycomed Imaging/<br />

Nycomed Ireland<br />

Nycomed Imaging/<br />

Nycomed Ireland<br />

Asta Medica<br />

Asta Medica<br />

4000. Onychon 125 Terbinafinum tablets 140,5mg N14 Lečiva a.s.<br />

4001. Onychon 250 Terbinafinum tablets 281mg N14 Lečiva a.s.<br />

4002. Ophthalin Natrii hyaluronas (medical<br />

device)<br />

4003. Ophthalin Plus Natrii hyaluronas (medical<br />

device)<br />

4004. Oral Poliomyelites Vaccine Poliomyelitis virus type 1+<br />

Poliomyelitis virus type 2+<br />

Poliomyelitis virus type 3<br />

4005. Oral Sabin Vero (Oral<br />

Poliomyelitis Vaccine)<br />

Poliomyelitis virus type 1+<br />

Poliomyelitis virus type 2 +<br />

Poliomyelitis virus type 3<br />

sol.for use in<br />

intraocu-lar<br />

surgery<br />

sol.for use in<br />

intraocu-lar<br />

surgery<br />

10mg/ml in pre-filled syringe<br />

1ml<br />

15mg/ml in pre-filled syringe<br />

1ml<br />

oral susp. >1000000 TCID 50+<br />

>100000 TCID 50 +<br />

>600000 TCID 50/0,1ml<br />

(dose); 1ml vial (10doses); 2ml<br />

vial (20doses) N10<br />

oral susp. >1 000 000 CCID50+><br />

100 000 CCID50+> 600 000<br />

CCID50/0,5ml N1; N10<br />

4006. Orfarin Warfarinum tab. 5mg<br />

N30; N100<br />

4007. Orfarin Warfarinum tab. 3mg<br />

N30; N100<br />

Fermentech Medical<br />

Fermentech Medical<br />

Pasteur Merieux<br />

Pasteur Merieux<br />

4008. Orfiril Acidum valproicum sol. for inj. 300mg/3ml N5 Pharma Hameln/<br />

Desitin<br />

4009. Orfiril 300 Natrii valproas enteric-coated<br />

tab.<br />

4010. Orfiril 300 retard Natrii valproas enteric-coated<br />

sustainedrelease<br />

tab.<br />

4011. Orfiril 600 Natrii valproas enteric-coated<br />

tab.<br />

4012. Orfiril long 1 000 mg Natrii valproas prolongedreleaseminitab.<br />

300mg<br />

N50; N100; N200<br />

300mg<br />

N50; N100; N200<br />

600mg<br />

N50; N100; N200<br />

Orion<br />

Orion<br />

Desitin<br />

Desitin<br />

Desitin<br />

1 000mg N50; N100; N200 Desitin/ P.T.Pellet<br />

Pharma/ Unionpack


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 297<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4013. Orfiril long 150 mg Natrii valproas prolongedrelease<br />

caps.<br />

4014. Orfiril long 300 mg Natrii valproas prolongedrelease<br />

caps.<br />

4015. Orfiril long 500 mg Natrii valproas prolongedreleaseminitab.<br />

Strength Manufacturer<br />

150mg N50;N100;N200 Desitin/ P.T. Pellet<br />

Pharma<br />

300mg N50;N100 Desitin/ P.T. Pellet<br />

Pharma<br />

500mg N50;N100;N200 Desitin/ P.T. Pellet<br />

Pharma/ Unionpack<br />

4016. Orfiril Saft Natrii valproas oral sol. 300mg/5ml 250ml Allphamed Pharbil/<br />

Desitin<br />

4017. Orgalutran 0,25 mg/0,5 ml Ganirelixum sol.for inj. 0,25mg/ 0,5ml pre-filled<br />

syringe N1;N5<br />

4018. Original Groser Bittner Balsam Angelicae radix+ Gentianae<br />

radix+ Menyanthidis folium+<br />

Absinthi herba+ Zingiberis<br />

radix+ Camphora+ Anisi<br />

stellati fructus+Myrrha<br />

granulatum+ Cardui benedicti<br />

herba+Centaurii herba+<br />

Caryophylli flos+ Galangae<br />

radix+ Liquiritiae radix+<br />

Calami radix+ Helenii radix<br />

sol. 1 360mg+ 500mg+ 120mg+<br />

35mg+ 15mg+ 950mg+<br />

46mg+ 700mg+ 15mg+<br />

13mg+30mg+ 14mg+<br />

170mg+ 47mg+20mg+<br />

1 380mg+ 1 360mg+ 14mg+<br />

680mg+280mg+6mg+<br />

970mg+5mg+31mg+ 38mg+<br />

17mg+11mg/ 1 l (Ethanolum<br />

40 vol.-%) 50ml; 100ml;<br />

250ml; 500ml<br />

4019. Orimeten Aminoglutethimidum tab. 250mg<br />

N100<br />

4020. Orizolin-1 000 Cefazolinum powder for sol.<br />

for inj.<br />

1000mg<br />

N1<br />

4021. Oronazol Ketoconazolum tab. 200mg N20 KRKA<br />

4022. Ortho-Gynest Estriolum vaginal cream 0,1mg/g<br />

80g<br />

4023. Ortofeno gelis Diclofenacum natricum gel 1g/100g 40g LMP<br />

4024. Ortophenum Diclofenacum sol. for inj. 25mg/ml<br />

3ml N10<br />

4025. Orungal Itraconazolum caps., hard 100mg<br />

N4; N15; N28<br />

4026. Oscillococcinum Anas barbariae hepatis et<br />

cordis extractum 200K<br />

4027. Ospamox 1 000 mg filmcoated<br />

tablets<br />

4028. Ospamox 125 mg/5 ml<br />

granules for oral suspension<br />

pellets 0,01ml/g<br />

N6<br />

Organon (Ireland)<br />

Richard Bittner<br />

Novartis Pharma<br />

Stein<br />

Cadila<br />

Cilag<br />

Kalceks<br />

Janssen<br />

Boiron<br />

Amoxicillinum film-coated tab. 1g N12 Biochemie<br />

Amoxicillinum granules for<br />

oral susp.<br />

125mg/5ml 60ml Biochemie<br />

4029. Ospamox 250 mg capsules Amoxicillinum caps. 250mg N1000 Biochemie<br />

4030. Ospamox 250 mg/5 ml<br />

granules for oral suspension<br />

4031. Ospamox 500 mg film-coated<br />

tablets<br />

4032. Ospen 1000 film-coated<br />

tablets<br />

4033. Ospen 1500 film-coated<br />

tablets<br />

Amoxicillinum granules for<br />

oral susp.<br />

250mg/5ml 60ml Biochemie<br />

Amoxicillinum film-coated tab. 500mg N12 Biochemie<br />

Phenoxymethyl-penicillinum<br />

kalicum<br />

Phenoxymethyl-penicillinum<br />

kalicum<br />

film-coated tab. 1000000 IU N12 Biochemie<br />

film-coated tab. 1500000 IU N12 Biochemie


EN<br />

298 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4034. Ospen 250mg tablets Phenoxymethyl-penicillinum tab. 250mg N1000 Biochemie<br />

4035. Ospen 400 Phenoxymethyl-penicillinum<br />

benzathinum<br />

4036. Ospen 400 granules for oral<br />

suspension<br />

Phenoxymethyl-penicillinum<br />

benzathinum<br />

4037. Ospen 500 film-coated tablets Phenoxymethyl-penicillinum<br />

kalicum<br />

4038. Ospen 750 Syrup Phenoxymethyl-penicillinum<br />

benzathinum<br />

oral susp. 400 000 IU/5ml 60ml Biochemie<br />

granules for<br />

oral susp.<br />

4039. Ospexin Cefalexinum film-coated tab. 1000mg<br />

N12<br />

4040. Ospexin 125mg/5ml granules<br />

for oral suspension<br />

Cefalexinum gran. for oral<br />

susp.<br />

400000IU/ 5ml 30g(60ml) Biochemie<br />

film-coated tab. 500000 IU N12 Biochemie<br />

syrup 750000IU/ 5ml 60ml Biochemie<br />

Biochemie<br />

125mg/5ml 60ml Biochemie<br />

4041. Ospexin 250mg capsules Cefalexinum caps. 250mg N12 Biochemie<br />

4042. Ospexin 250mg/5ml granules<br />

for oral suspension<br />

Cefalexinum gran. for oral<br />

susp.<br />

250mg/5ml 60ml Biochemie<br />

4043. Ospexin 500mg capsules Cefalexinum caps. 500mg N12 Biochemie<br />

4044. Ospexin 500mg film-coated<br />

tablets<br />

Cefalexinum film-coated tab. 500mg N12 Biochemie<br />

4045. Ospolot mite Sultiamum film-coated tab. 50mg<br />

N50<br />

4046. Ossin Natrii fluoridum enteric-coated<br />

sustainedrelease<br />

tab.<br />

4047. Osteocare Calcium+ Magnesium+<br />

Zincum+ Colecalciferolum<br />

4048. Osteogenon Ossein hydroxyapatite<br />

compound<br />

4049. Osteoheel S Hekla Lava D6+<br />

Kalium iodatum D4<br />

+Asa foetida D4+<br />

Stillingia sylvatica D4+<br />

Araneus diadematus D6+<br />

Natrium sulfuricum D4+<br />

Mercurius praecipitatus ruber<br />

D9+Calcium phosphoricum<br />

D6<br />

40mg<br />

N50<br />

oral liquid 150mg+ 75mg+ 3mg+<br />

1,9µg/5ml 200ml<br />

tab. 800mg<br />

N40<br />

tab. 30mg+30mg+<br />

30mg+30mg+<br />

30mg+30mg+<br />

60mg+60mg<br />

4050. Otinum Cholini salicylas ear drops 2g/10g<br />

10ml<br />

Desitin<br />

Grunenthal<br />

Vitabiotics<br />

Progipharm<br />

4051. Otipax Phenazonum+ Lidocainum ear drops,sol. 4g+ 1g/100g 16g Biocodex<br />

4052. Otomize Neomycini sulfas+<br />

Dexamethasonum +Acidum<br />

aceticum glaciale<br />

4053. Otosporin Polymyxinum B+<br />

Neomycinum+<br />

Hydrocortisonum<br />

ear spray 0,5%w/w+ 0,1%w/w+ 2%w/w<br />

5ml<br />

ear drops,<br />

sol.<br />

4054. Otrivin Xylometazolinum nasal metereddose<br />

spray<br />

10000U+3400U+ 10mg/ml<br />

5ml<br />

Heel<br />

ICN Polfa Rzeszow<br />

Stafford-Miller<br />

0,05% 10ml Novartis<br />

Glaxo Wellcome


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 299<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4055. Otrivin Xylometazolinum nasal metereddose<br />

spray<br />

Strength Manufacturer<br />

0,1% 10ml Novartis<br />

4056. Otrivin 0,05 % Xylometazolinum nasal drops, sol. 0,5mg/ml 10ml Novartis Consumer<br />

4057. Otrivin 0,1 % Xylometazolinum nasal drops, sol. 1mg/ml 10ml Novartis Consumer<br />

4058. Otrivin Menthol Xylometazolinum nasal metereddose<br />

spray<br />

4059. Ovestin Estriolum vaginal cream 1mg/g<br />

15g<br />

4060. Ovestin 0,5 mg Estriolum ovules 0,5mg<br />

N15<br />

4061. Ovidrel 250µg Choriogonadotropin alfa powder and<br />

solvent for sol.<br />

for inj.<br />

4062. Ovulavit (Ovuliavitas) Ol.Salmoni+Ol.Oenotherae +<br />

Extr. Hippocastani sicc.+<br />

Extr.Cimicifugae sicc. +<br />

Extr.Agnicasti sicc. +<br />

Magnesium+ Chromium+<br />

Nicotinamidum+Pyridoxinum+<br />

Tocopherolum + Acidum<br />

adenosinmonophos-phoricum<br />

4063. Oxazepam Alpharma Tablets<br />

10 mg<br />

1mg/ml 10ml Novartis Consumer<br />

Organon<br />

E.Pharma<br />

250µg N1;N2;N10 Industria<br />

Farmaceutica Serono<br />

S.p.A.<br />

caps., soft 250mg+250mg+187,5mg+<br />

25mg+50mg+57mg+ 62µg+<br />

18mg+3mg+15mg+5mg<br />

N40<br />

Arco-Chemie<br />

Oxazepamum tab. 10mg N20; N50 Alpharma<br />

4064. Oxazepam-ratiopharm 50 Oxazepamum tab. 50mg N20 Merckle<br />

4065. Oxis Turbuhaler Formoterolum inhal. powder 9µg/dose 60 doses AstraZeneca<br />

4066. Oxis Turbuhaler Formoterolum inhal powder 4,5µg/dose 60 doses AstraZeneca<br />

4067. Oxolinum ung. 0,25% Oxolinum tepalas 0,25% 10g Liuks<br />

4068. Oxy 10 Benzoylis peroxidum lotion for<br />

topical applic.<br />

4069. Oxy 5 Benzoylis peroxidum lotion for<br />

topical applic.<br />

4070. Oxycort Oxytetracyclinum+<br />

Hydrocortisonum<br />

4071. Oxycort Oxytetracyclinum+<br />

Hydrocortisonum<br />

10% w/w<br />

30ml<br />

5% w/w<br />

30ml<br />

ointment 30mg+10mg/g 10g Jelfa<br />

aerosol for<br />

external use<br />

300mg+ 100mg/55ml<br />

55ml (75g)<br />

4072. Oxygenium medicinalis Oxygenium gas 99,7% 3,5kubm; 6,3 kubm;<br />

8,0 kubm<br />

SmithKline Beecham<br />

SmithKline Beecham<br />

Polfa Tarchomin<br />

Boc Gazy<br />

4073. Oxytocin Oxytocinum sol. for inj. 1IU/ml amp. 2ml N5 Ferring-Lečiva<br />

4074. Oxytocin Oxytocinum sol. for inj. 5IU/ml amp. 1ml N5 Ferring-Lečiva


EN<br />

300 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4075. Oxytocin-Richter Oxytocinum sol. for inj. 5IU/ml<br />

1ml amp. N5<br />

4076. Padma 28 Aegle sepiar fructus+ Amomi<br />

fructus+ Aquilegiae vulgaris<br />

herba+ Calcii sulfas pulv.+<br />

Calendulae cum calycibus flos<br />

+Dextrocamphora+<br />

Cardamomi fructus+<br />

Caryophylii flos +Costi amari<br />

radix+ Hedychii rhizoma+<br />

Lactucae sativae folium+<br />

Lichen islandicus+ Liquiritiae<br />

rad..<br />

4077. Paidoflor Lactobacillus acidophilus 10*9-<br />

10*10 viable<br />

bacteria/ g<br />

tab. 20mg+25mg+15mg+ 20mg+<br />

5mg+4mg+30mg+12mg+<br />

40mg+10mg+6mg+40mg+<br />

15mg+35mg+ 30mg+15mg+<br />

15mg+ 15mg+30mg+10mg+<br />

1mg+10mg N60; N100<br />

tab. 20mg<br />

N20; N50; N100<br />

Strength Manufacturer<br />

4078. Palin Acidum pipemidicum caps. 200mg N20 Lek<br />

4079. Pamba Acidum 4aminomethylbenzoicum<br />

Gedeon Richter<br />

Padma<br />

tab. 250mg N10;N20 OPW<br />

4080. Pamid Indapamidum tab. 2,5mg<br />

N30; N100<br />

4081. Pamitor Disodium pamidronate solution for<br />

infusion<br />

4082. Pamitor Disodium pamidronate solution for<br />

infusion<br />

4083. Pamitor Disodium pamidronate solution for<br />

infusion<br />

Ardeypharm<br />

CTS<br />

15mg/ml amp. N1 Wulfing Pharma<br />

GmbH<br />

30mg/2ml amp.N1 Wulfing Pharma<br />

GmbH<br />

60mg/4ml amp. N1 Wulfing Pharma<br />

GmbH<br />

4084. Pamitor Disodium pamidronate solution for inf. 90mg/6ml amp. N1 Wulfing Pharma<br />

GmbH<br />

4085. Pamol 500 Paracetamolum tab. 500mg<br />

N10<br />

4086. PAN-A.S.L. 1 800 mg Lysini acetylsalicylas powder for<br />

sol.for inj.<br />

4087. PAN-A.S.L. 900 mg Lysini acetylsalicylas powder for<br />

sol.for inj.<br />

Nycomed SEFA/<br />

Nycomed Danmark<br />

1800mg/vial N100 Panpharma<br />

900mg/vial N100 Panpharma<br />

4088. Panadol Baby Paracetamolum oral susp. 120mg/5ml 100ml SmithKline Beecham<br />

Liquides<br />

4089. Panadol Extra Tablets Paracetamolum+ Coffeinum tab. 500mg+ 65mg N12;N24 SmithKline Beecham<br />

4090. Panadol Rapide Paracetamolum film-coated tab. 500mg<br />

N10; N20<br />

SmithKline Beecham<br />

4091. Panadol Soluble Tablets Paracetamolum efferv. tab. 500mg N12 SmithKline Beecham<br />

4092. Panadol Tablets Paracetamolum film-coated tab. 500mg N12; N24 SmithKline Beecham<br />

4093. PAN-Amoxicillin<br />

250 mg/5 ml<br />

Amoxicillinum powder for<br />

syrup<br />

250mg/5ml 60ml Panpharma<br />

4094. PAN-Amoxicillin 500 mg Amoxicillinum caps., hard 500mg N360 Panpharma<br />

4095. Pan-Amoxicillin 1 g Amoxicillinum powder for sol.<br />

for inj.<br />

4096. Pan-Amoxicillin 500 mg Amoxicillinum powder for sol.<br />

for inj.<br />

1g/vial<br />

N50<br />

Panpharma<br />

500mg/vial N50 Panpharma


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 301<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4097. PAN-Ampicillin 1 g Ampicillinum powder for inj. 1g N100 Panpharma<br />

4098. PAN-Ampicillin<br />

250 mg/5 ml<br />

Ampicillinum powder for<br />

syrup<br />

4099. PAN-Ampicillin 500 mg Ampicillinum powder for sol.<br />

for inj.<br />

250mg/5ml 60ml Panpharma<br />

500mg N100 Panpharma<br />

4100. PAN-Ampicillin 500 mg Ampicillinum caps., hard 500mg N360 Panpharma<br />

4101. Panangin Magnesii aspartas+ Kalii<br />

aspartas<br />

4102. Panangin Magnesii aspartas+ Kalii<br />

aspartas<br />

sol. for inj. 400mg+ 452mg/10ml amp.N5 Gedeon Richter<br />

film-coated tab. 140mg+ 158mg N50 Gedeon Richter<br />

4103. Panatus Butamiratum sir. 4mg/5ml 200ml KRKA<br />

4104. Panatus Butamiratum film-coated tab. 20mg<br />

N10<br />

4105. Panatus forte Butamiratum film-coated tab. 50mg<br />

N10<br />

4106. Panatus forte Butamiratum sir. 7,5mg/5ml 200ml KRKA<br />

4107. Pan-Cefazolin 1 g Cefazolinum powder for sol.<br />

for inj.<br />

4108. Pangrol 10 000 Lipasum+ Amylasum+<br />

Proteasum<br />

4109. Pangrol 25 000 Lipasum+ Amylasum+<br />

Proteasum<br />

4110. PAN-Kanamycin 1 g Kanamycinum powder for<br />

sol.for inj.<br />

4111. Pankreatino 250mg tablete˙s Pancreatinum enterosoluble<br />

tab.<br />

4112. PAN-Oxacillin 1g Oxacillinum powder for sol.<br />

for inj.<br />

1g/vial<br />

N50<br />

caps. 10000U+ 9000U+ 500U N20;<br />

N50; N100; N200<br />

caps. 25 000U+ 22 500U+ 1 250U<br />

N20; N50; N100;N200<br />

KRKA<br />

KRKA<br />

Panpharma<br />

Berlin-Chemie<br />

Berlin-Chemie<br />

1g N100 Panpharma<br />

250mg<br />

N50<br />

Endokrininiai<br />

preparatai<br />

1g N100 Panpharma<br />

4113. PanOxyl Acnegel 5 Benzoylis peroxidum gel 5% 40g Stiefel Laboratories<br />

4114. PAN-Penicillin G Sodium<br />

1 MIU<br />

4115. PAN-Penicillin G Sodium<br />

5 MIU<br />

Benzylpenicillinum powder for sol.<br />

for inj.<br />

Benzylpenicillinum powder for sol.<br />

for inj.<br />

4116. Pan-Streptomycin 1 g Streptomycinum powder for sol.<br />

for inj.<br />

1000000IU N100 Panpharma<br />

5000000IU N50 Panpharma<br />

1g/vial<br />

N50<br />

4117. Panteston Testosterone undecanoate caps. 40mg<br />

N60<br />

4118. Panthenol Spray Dexpanthenolum cutaneous<br />

spray, emulsion<br />

4119. Panthenol-ratiopharm zˇaizdu˛<br />

balzamas<br />

4120. Panzynorm forte Lipasum+ Amylasum+<br />

Trypsinum+ Chymotripsinum+<br />

Pepsinum+ Acidum cholicum<br />

Panpharma<br />

Scherer<br />

4,63g/100g 130g Chauvin ankerpharm<br />

Dexpanthenolum cream 50mg/g 35g Merckle<br />

film-coated tab. 6000 FIPUnits+<br />

7500 FIPUnits+ 450 FIPUnits+<br />

1500FIPUnits+ 50PU+ 13,5mg<br />

N30<br />

KRKA


EN<br />

302 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

4121. Panzynorm forte-N Lipasum, amylasum,<br />

proteasum<br />

4122. Panzytrat Lipasum+Amylasum+<br />

Proteasum<br />

Pharmaceutical<br />

form<br />

film-coated<br />

tablet<br />

Strength Manufacturer<br />

N10;N30;N100 KRKA<br />

caps., hard 25000U+ 22500U+ 1250U<br />

N20;N50; N100<br />

4123. Papaverini hydrochloridum Papaverini hydrochloridum tab. 0,04g N10 Liuks<br />

4124. Papaverino hidrochlorido<br />

2 % tirpalas injekcijoms<br />

Papaverinum sol. for inj. 20mg/ml<br />

2ml amp.<br />

N10<br />

Knoll<br />

Endokrininiai<br />

preparatai<br />

4125. Paprastojo krapo vaisiai Fruct. Anethi herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

4126. Paprastosios aviete˙s vaisiai Fruct.Rubi idaei tea Švenčioniu˛<br />

vaistazˇole˙s<br />

4127. Paprastosios rasakilos zˇole˙ Alchemillae vulgaris herba herbal tea 50g Švenčioniu˛<br />

vaistazˇole˙s<br />

4128. Paprastu˛ju˛ amalu˛ ūgliai ir lapai Cormus et folia Visci albi subst. 25kg Švenčioniu˛<br />

vaistazˇole˙s<br />

4129. Paprastu˛ju˛ kiečiu˛ zˇole˙<br />

(smulkinta)<br />

Herba Artemisiae vulgaris 25kg Švenčioniu˛<br />

vaistazˇole˙s<br />

4130. Paprastu˛ju˛ krapu˛ vaisiai Fructus Anethi graveolentis herbal tea 50g Švenčioniu˛<br />

vaistazˇole˙s<br />

4131. Para Plus Permethrin+Malathion+<br />

Piperonyl butoxide<br />

aerosol 0,45g+0,225g+1,8g/90g can S.C.A.T.<br />

4132. Paracetamol Paracetamolum tab. 500mg N100 Cadila<br />

4133. Paracetamol<br />

500 mg<br />

Paracetamolum tab. 500mg<br />

N20<br />

Balkan-pharma-<br />

Dupnitza<br />

4134. Paracetamol Paracetamolum tablets 500mg N20;N400 Sopharma PLC<br />

4135. Paracetamol 500 Stada Paracetamolum tab. 500mg<br />

N10; N30<br />

4136. Paracetamol DM Paracetamolum+<br />

Dextromethorphani<br />

hydrobromidum<br />

effervescent<br />

tablet<br />

Stada<br />

300mg+7,5mg N10;N20 OU Vitale-XD<br />

4137. Paracetamol Galena Paracetamolum syr. Liuks<br />

4138. Paracetamol Tablets BP<br />

500 mg<br />

Paracetamolum tab. 500mg<br />

N20; N30<br />

4139. Paracetamolio 500 mg tablete˙s Paracetamolum tab. 500mg N10;N20;N50 Bakteriniai<br />

preparatai<br />

4140. Paracetamolio 500 mg tablete˙s Paracetamolum tab. 500mg<br />

N20<br />

4141. Paracetamolio 500 mg tablete˙s Paracetamolum tab. 500mg<br />

N10; N100<br />

4142. Paracetamolis 500 mg Paracetamolum tab. 500mg<br />

N10<br />

Cox<br />

Endokrininiai<br />

preparatai<br />

4143. Paracetamolis 500 mg MDF Paracetamolum tab. 500mg N10 Medicata filia<br />

4144. Paracetamolis vaikams Paracetamolum syr. 100 ml — 2,4 g Liuks<br />

Sanitas<br />

4145. Paracetamol-ratiopharm Paracetamolum supp. 500mg, N10 Merckle<br />

Liuks


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 303<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4146. Paracetamol-ratiopharm 125 Paracetamolum supp. 125mg, N10 Merckle<br />

4147. Paracetamol-ratiopharm 250 Paracetamolum supp. 250mg N10 Merckle<br />

4148. Paracetamol-ratiopharm<br />

Losung<br />

Paracetamolum oral sol. 200mg/5ml 100ml Merckle<br />

4149. Paraffinum liquidum Paraffinum liquidum liquidum 20g; 100g; 750g Hasco-Lek<br />

4150. Parafinas skystasis Paraffinum liquidum ol. 100ml KMU vaistine˙<br />

4151. Paraplatin Carboplatinum sol. for inj. i.v. 10mg/ml<br />

5ml; 15ml; 45ml<br />

4152. Pariet Rabeprazolum natricum gastro-resistant<br />

tab.<br />

4153. Pariet Rabeprazolum natricum gastro-resistant<br />

tab.<br />

10mg<br />

N7; N14; N28<br />

20mg<br />

N7; N14; N28<br />

Bristol-Myers Squibb<br />

Eisai Co.<br />

Eisai Co.<br />

4154. Parkopan 2 Trihexylphenidylum tablets 2mg N50;N100 Salutas Pharma<br />

GmbH<br />

4155. Parkopan 5 Trihexylphenidylum tablets 5mg N50;N100 Salutas Pharma<br />

GmbH<br />

4156. Parlazin Cetirizinum film-coated tab. 10mg N10;N30 Egis Pharmaceuticals<br />

Ltd.<br />

4157. Parlazin Cetirizinum oral drops, sol. 10mg/ml 20ml Egis Pharmaceuticals<br />

Ltd.<br />

4158. Parlodel Bromocriptinum tab. 2,5mg<br />

N30<br />

4159. Parlodel Bromocriptinum caps. 5mg<br />

N30<br />

4160. Parodontal F5 med Phenyli salicylas+ Eugenolum+<br />

Thymolum+ Caryophylii floris<br />

oleum +Salviae officinalis<br />

oleum+ Menthae arvensis<br />

oleum<br />

gingival sol. 500mg+250mg+360mg+<br />

500mg+500mg+250mg/ 100g<br />

20ml; 100ml<br />

Novartis Pharma<br />

Novartis Pharma<br />

Wernigerode<br />

4161. Paroxat 20 Hexal Paroxetinum film-coated tab. 20mg N28 A/S GEA<br />

Farmaceutisk Fabrik<br />

4162. Paroxat 40 Hexal Paroxetinum film-coated tab. 40mg N28 A/S GEA<br />

Farmaceutisk Fabrik<br />

4163. Pasifloros zˇole˙ Herb. Passiflorae herbal tea 1,5g<br />

N25;50g<br />

4164. Pasifloru˛ ekstraktas Passiflorae herba extr. 1000 g Ethanolum ad 1 l<br />

25 ml, 50 ml,<br />

100 ml<br />

4165. Passidorm Passiflora incarnata O+<br />

Zincum metallicum D6+<br />

Lupulus Ø+ Eschscholzia<br />

californica ex herba flor.rec.Ø<br />

+(Ethanolum 0,9226g/10g)<br />

4166. Pasteur Antirabies Serum<br />

1 000 IU<br />

Equine antirabies<br />

immunoglobulin fragments<br />

drops 3g+0,1g+ 3g+ 2,5g/10g (11ml)<br />

30ml;50ml<br />

Acorus Calamus<br />

Bakteriniai<br />

preparatai<br />

DHU<br />

sol. for inj. >1000IU/ 5ml vial N1; N10 Pasteur Merieux<br />

4167. Pataisu˛ sporos Lycopodium powder 20g Karvelio terapijosfitoterapijos<br />

i˛mone˙


EN<br />

304 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4168. Pataisu˛ sporos Lycopodium powder 20g Švenčioniu˛<br />

vaistazˇole˙s<br />

4169. Patentex oval N Nonoxinolum vaginal supp. 75mg<br />

N6; N12<br />

Merz+Co.<br />

4170. Pausogest Estradiolum+ Norethisteronum coated tab. 2mg+1mg N28 Gedeon Richter<br />

4171. Pavulon Pancuronii bromidum sol. for inj. 2mg/ml amp. 2ml N10; N50;<br />

N100<br />

4172. Paxeladine Oxeladinum caps. 40mg<br />

N15<br />

Organon/<br />

Laboratoires<br />

Organon<br />

Beaufour Ipsen<br />

4173. Paxeladine Oxeladinum syrup 10mg/5ml 125ml Beaufour Ipsen<br />

4174. Paxene Paclitaxel concentrate for<br />

infusion<br />

6mg/ml 30mg/5ml;<br />

100mg/16,7ml; 150mg/25ml;<br />

300mg/50ml<br />

4175. Paxirasol Bromhexinum sol.for inj. 4mg/2ml amp. N5 Egis<br />

4176. Pedeks 0,5 % Permethrinum lotion 4,2mg/ml 60ml LMP<br />

4177. Peditrace compos. concentrate for<br />

sol. for inf.<br />

4178. Pegasys Peginterferon alfa-2a solution for<br />

injection<br />

4179. Pegasys Peginterferon alfa-2a solution for<br />

injection<br />

4180. Pegasys 180 µg Peginterferon alfa-2a solution for<br />

injection<br />

4181. PegIntron Peginterferon alfa-2b powder and<br />

solvent for sol.<br />

for inj.<br />

4182. PegIntron Peginterferon alfa-2b powder and<br />

solvent for sol.<br />

for inj.<br />

4183. PegIntron Peginterferon alfa-2b powder and<br />

solvent for sol.<br />

for inj.<br />

4184. PegIntron Peginterferon alfa-2b powder and<br />

solvent for sol.<br />

for inj.<br />

Ivax-CR a.s./Galena<br />

a.s.<br />

N10×10ml Fresenius Kabi Norge<br />

for Fresenius Kabi<br />

Sweden<br />

135µg/0,5ml pre-filled syringe<br />

+injection needle N1;N4<br />

F.Hoffmann-La<br />

Roche Ltd.<br />

135µg/ml N1; N4 vial F.Hoffmann-La<br />

Roche Ltd.<br />

180µg/0,5ml pre-filled syringe<br />

+injection needle N1;N4<br />

80 µg/0,5ml vial, 1 amp. of<br />

solvent, 1 inj. syringe, 2 inj.<br />

needles, and 1 cleansing swab<br />

N1<br />

100 µg/0,5ml vial, 1 amp. of<br />

solvent, 1 inj. syringe, 2 inj.<br />

needles, and 1 cleansing swab<br />

N1<br />

120 µg/05ml vial, 1 amp. of<br />

solvent, 1 inj. syringe, 2 inj.<br />

needles, and 1 cleansing swab<br />

N1<br />

50 µg/0,5ml vial, 1 amp. of<br />

solvent, 1 inj. syringe, 2 inj.<br />

needles, and 1 cleansing swab<br />

N1<br />

F.Hoffmann-La<br />

Roche Ltd.<br />

Schering-Plough<br />

Schering-Plough<br />

Schering-Plough<br />

Schering-Plough<br />

4185. Pelkine˙s vingiorykšte˙s tinktūra Filipendula ulmaria solution 25ml Vilniaus farmacijos<br />

fabrikas AB<br />

4186. Pelkine˙s vingiorykšte˙s zˇole˙ Herb.Filipendulae Ulmariae herbal tea 100g Švenčioniu˛<br />

vaistazˇole˙s<br />

4187. Pelynu˛ tinktūra Artemisiae absinthii herba tinct. 200g (Ethanolum 70% ad 1l)<br />

25ml<br />

4188. Penester Finasteridum film-coated tab. 5mg<br />

N30<br />

Vilniaus f.f.<br />

Lečiva


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 305<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4189. Penicillin G Benzylpenicillinum powder for sol.<br />

for inj.<br />

4190. Penicillin G Benzylpenicillinum powder for sol.<br />

for inj.<br />

4191. Penicillin G Benzylpenicillinum powder for sol.<br />

for inj.<br />

4192. Penicillin G Sodium<br />

‘Biochemie’1 000 000 IU vials<br />

Benzylpenicillinum powder for sol.<br />

for inj.<br />

4193. Penicillin V-ratiopharm TS Phenoxymethyl-penicillinum powder for oral<br />

sol.<br />

1 000 000 UI/<br />

vial (600mg) N10<br />

5 000 000 UI/<br />

vial (3g) N10<br />

500 000 UI/<br />

vial (300mg) N10<br />

Strength Manufacturer<br />

Balkanpharma-<br />

Razgrad<br />

Balkanpharma-<br />

Razgrad<br />

Balkanpharma-<br />

Razgrad<br />

1000000 IU/vial N100 Biochemie<br />

236mg/5ml 100ml Biochemie<br />

4194. Penicillin-V-Wolff Phenoxymethyl-penicillinum film-coated tab. 1000000 IU N10; N20; N30 Wolff<br />

4195. PENTAct-HIB (Haemophilus<br />

type b conjugated vaccine and<br />

absorbed diphtheria, tetanus,<br />

pertussis and inactivated<br />

poliomyelitis vaccine)<br />

Powder: Haemophilus<br />

influenza type b<br />

polysaccharide conjugated with<br />

tetanus protein; Suspension (as<br />

diluent): Purified diphtheriae<br />

toxoid+ Purified tetanus<br />

toxoid+ Bordetella pertussis,<br />

inactivated+ Inactivated<br />

poliovirus vaccines type 1+<br />

type 2+ type 3<br />

powder and<br />

susp. for susp.<br />

for inj.<br />

10µg/vial; >=30IU+ >=60IU+<br />

>=4IU+ 40DU+ 8DU+ 32DU<br />

/0,5ml syringe N1<br />

4196. Pentaerythritol 100 Pentaerythrityl tetranitrate tab. 100 mg N30 Liuks<br />

4197. Pentaerythritol compositum Pentaerythrityl tetranitrate +<br />

nitroglicerin<br />

tab. (20 mg +0,5 mg) N20 Liuks<br />

4198. Pentaerythritol forte Pentaerythrityl tetranitrate tab. Liuks<br />

4199. Pentaglobin Human plasma protein (IgM+<br />

IgA+IgG)<br />

4200. Pentaglobin Human plasma protein (IgM+<br />

IgA+IgG)<br />

sol. for inf. 50mg (6mg+6mg+ 38mg)/ml<br />

10ml; 20ml amp. N1<br />

sol. for inf. 50mg (6mg+ 6mg+38mg) /ml<br />

50ml; 100ml bottles N1<br />

4201. Pentagluci-dum gran Pentaglucidum gran. 2g N1; N50; N10; N20; N30,<br />

N50<br />

4202. Pentasa Mesalazinum rectal susp. 1g/100ml<br />

N7<br />

4203. Pentasa Mesalazinum slow-release<br />

tab.<br />

500mg<br />

N100<br />

Pasteur Merieux<br />

Biotest<br />

Biotest<br />

Liuks<br />

Ferring<br />

Ferring<br />

4204. Pentasa Mesalazinum supp. 1g N28 Ferring<br />

4205. Pentaxim Diphtheria toxoid+Tetanus<br />

toxoid+Pertussis toxoid+<br />

Filamentous haemagglutinin+<br />

Inactiv.type 1 poliovirus D<br />

antigen +Inactiv. type 2<br />

poliovirus D antigen+ Inactiv.<br />

type 3 poliovirus D antigen;<br />

Haemophilus influenzae type b<br />

polysacch conjug. to tetanus<br />

protein<br />

powder and<br />

susp. for inj.<br />

30IU+40IU+25µg+25µg+<br />

40units+8units+32units;<br />

10µg/dose<br />

N1;N10<br />

4206. Pentilin Pentoxifyllinum sol. for inj. 300mg/15ml amp.N10 KRKA<br />

4207. Pentilin Pentoxifyllinum prolongedrelease<br />

tab.<br />

400mg<br />

N20<br />

4208. Pentilin Pentoxifyllinum sol. for inj. 100mg/5ml amp. N5 KRKA<br />

Pasteur Merieux<br />

KRKA


EN<br />

306 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4209. Pentilin forte Pentoxifyllinum prolongedrelease<br />

tab.<br />

Strength Manufacturer<br />

600mg N20 KRKA<br />

4210. Pentoksifilinas Pentoxifyllinum tab., drag. 100 mg N60 Liuks<br />

4211. Pentoksifilino 2 % tirpalas<br />

injekc.<br />

Pentoxifillinum sol. for inj. 2 % Endokrininiai<br />

preparatai<br />

4212. Pentoxifyllin Pentoxifylline prolonged<br />

release tablet<br />

4213. Pentoxifylline-Rivo 100 Pentoxifyllinum enteric-coated<br />

tab.<br />

400mg N20 Balkanpharma-<br />

Dupnitza AD<br />

100mg<br />

N60<br />

4214. Pentoxifylline-Rivo 400 Retard Pentoxifyllinum retard tab. 400mg<br />

N20<br />

4215. Pentoxifyllin-ratiopharm 400 Pentoxifyllinum prolongedrelease<br />

tab.<br />

400mg<br />

N20<br />

Rivopharm<br />

Rivopharm<br />

Merckle<br />

4216. Pentrexyl Ampicillinum powder for inj. 2000mg N1 N50 Bristol-Myers Squibb<br />

4217. Pentrexyl Ampicillinum powder for inj. 250mg N1;N50 Bristol-Myers Squibb<br />

4218. Pentrexyl Ampicillinum powder for inj. 1000mg N1;N50 Bristol-Myers Squibb<br />

4219. Peponen Ol.Cucurbitae pepo caps. 300mg N100 Biogal<br />

4220. Perazin 100 Perazinum dimaleate tab. 100 mg N30; N500; N1000 Liuks<br />

4221. Perazin 25 Perazinum dimaleate tab. 25 mg N20; N500; N1000 Liuks<br />

4222. Perfocrat Intr. Hyperici+ Intr. Melissae+<br />

Extr. Crataegi fl.<br />

4223. Pergonal 75 Menotropin corresp.to (1:1):<br />

Human urinary follicle<br />

stimulating hormone+ Human<br />

urinary luteinizing hormone<br />

4224. Peritol Cyproheptadini<br />

hydrochloridum<br />

4225. Peritol syrup Cyproheptadini<br />

hydrochloridum<br />

4226. Peritoneal Dialysis Solution<br />

CAPD/DPCA 11<br />

4<strong>227</strong>. Peritoneal Dialysis Solution<br />

CAPD/DPCA 12<br />

4228. Peritoneal Dialysis Solution<br />

CAPD/DPCA 10<br />

4229. Peritoneal Dialysis Solution<br />

CAPD/DPCA 2<br />

4230. Peritoneal Dialysis Solution<br />

CAPD/DPCA 3<br />

Natrii chloridum+ Natrii<br />

lactas+ Calcii chloridum+<br />

Magnesii chloridum+<br />

Glucosum<br />

Natrii chloridum+ Natrii<br />

lactas+ Calcii chloridum+<br />

Magnesii chloridum+<br />

Glucosum<br />

Natrii chloridum+ Natrii<br />

lactas+ Calcii chloridum+<br />

Magnesii chloridum+<br />

Glucosum<br />

Natrii chloridum+ Natrii<br />

lactas+ Calcii chloridum+<br />

Magnesii chloridum+<br />

Glucosum<br />

Natrii chloridum+ Natrii<br />

lactas+ Calcii chloridum+<br />

Magnesii chloridum+<br />

Glucosum<br />

oral sol. 34partes+ 33partes+ 33partes<br />

30g; 100g<br />

powder and<br />

solvent for sol.<br />

for inj. i.m.<br />

75IU+75IU N1; N10 Serono<br />

tab. 4mg N20 Egis<br />

syrup 40mg/100ml 100ml Egis<br />

sol. for<br />

peritoneal<br />

dialysis<br />

sol. for<br />

peritoneal<br />

dialysis<br />

sol. for<br />

peritoneal<br />

dialysis<br />

sol. for<br />

peritoneal<br />

dialysis<br />

sol. for<br />

peritoneal<br />

dialysis<br />

5,786g+ 3,925g+ 0,147g+<br />

0,1017g+ 42,5g/l 1000ml;<br />

1500ml; 2000ml; 2500ml;<br />

5000ml<br />

5,786g+ 3,925g+ 0,147g+<br />

0,1017g+ 22,7g/l 1000ml;<br />

1500ml; 2000ml; 2500ml;<br />

5000ml<br />

5,786g+ 3,925g+ 0,147g+<br />

0,1017g+ 15g/l 1000ml;<br />

1500ml; 2000ml; 2500ml;<br />

5000ml<br />

5,786g+ 3,925g+ 0,2573g+<br />

0,1017g+ 15g/ l 500ml;<br />

750ml; 1000ml; 1500ml;<br />

2000ml; 2500ml; 5000ml<br />

5,786g+ 3,925g+ 0,2573g+<br />

0,1017g+ 42,5g/l 250ml;<br />

500ml; 750ml; 1000ml;<br />

1500ml; 2000ml; 2500ml;<br />

5000ml<br />

Herbapol Kle˛ce<br />

Fresenius Medical<br />

Care Deutschland<br />

Fresenius Medical<br />

Care Deutschland<br />

Fresenius Medical<br />

Care Deutschland<br />

Fresenius Medical<br />

Care Deutschland<br />

Fresenius Medical<br />

Care Deutschland


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 307<br />

No. Commercial name General name<br />

4231. Peritoneal Dialysis Solution<br />

CAPD/DPCA 4<br />

Natrii chloridum+ Natrii<br />

lactas+ Calcii chloridum+<br />

Magnesii chloridum+<br />

Glucosum<br />

Pharmaceutical<br />

form<br />

sol. for<br />

peritoneal<br />

dialysis<br />

Strength Manufacturer<br />

5,786g+ 3,925g+ 0,2573g+<br />

0,1017g+ 22,73g/l 250ml;<br />

500ml; 750ml; 1000ml;<br />

1500ml; 2000ml; 2500ml;<br />

5000ml<br />

4232. Permax Pergolidum tab. 0,05mg N30 Eli Lilly<br />

4233. Permax Pergolidum tab. 0,25mg Eli Lilly<br />

4234. Permax Pergolidum tab. 1mg N30 Eli Lilly<br />

4235. Permetrino 4 % tepalas Permethrinum ointment 40mg/g<br />

45g<br />

4236. Permixon Lipidosterolic extract of<br />

Serenoa Repens<br />

4237. Perozon Rosmarin Rosmarinus officinalis<br />

(Rosmarini aetheroleum)<br />

4238. Persen Valerianae officinalis radicis<br />

extractum siccum (5-7:1)+<br />

Melissae officinalis folii<br />

extractumsiccum (5-8:1) +<br />

Menthae piperitae folii<br />

extractum siccum<br />

(5-9:1)<br />

4239. Persen forte Valerianae officinalis radicis<br />

extractum siccum (5-7:1)+<br />

Melissae officinalis folii extractum<br />

siccum (5-8:1)+<br />

Menthae piperitae extractum<br />

siccum(5-9:1)<br />

4240. Pertusinas Extr.Serpylii fl.+ Kalii<br />

bromidum+ Ethanolum 80%<br />

caps. 160mg<br />

N60<br />

flussiges<br />

medizinisches<br />

Badekonzentrat<br />

Fresenius Medical<br />

Care Deutschland<br />

LMP<br />

coated tab. 50mg+ 25mg+ 25mg N40 Lek<br />

caps. 125mg+ 25mg+ 25mg N20 Lek<br />

4241. Peteha Protionamidum film-coated tab. 250mg<br />

N50; N100<br />

Pierre Fabre<br />

W.Spitzner<br />

Arzneimittel-fabrik<br />

GmbH<br />

sol. 12g+1g+ 5g/100g 125g Vilniaus f.f.<br />

4242. Pethidine Pethidini inj. 50mg/ml 1ml; 2ml N10 Icelandic<br />

Pharmaceuticals<br />

4243. Petidino hidrochlorido 5%<br />

tirpalas injekcijoms<br />

Pethidinum solution for<br />

injection<br />

4244. Petnidan Ethosuximidum caps. 250mg<br />

N50; N100<br />

Fatol<br />

5% 1ml amp. N10 Endokrininiai<br />

preparatai AB<br />

Scherer / Desitin<br />

4245. Petnidan Saft Ethosuximidum oral sol. 250mg/5ml 250ml Haupt Pharma /<br />

Desitin<br />

4246. Pexal-400 Depotabs Pentoxifyllinum slow-release<br />

tab.<br />

400mg N20 Mepha<br />

4247. Pfeil Ibuprofenum film-coated tab. 200mg N10; N20 Stada<br />

4248. Pharmacitron (stipriai<br />

veikiantis citrinu˛ skonio)<br />

Paracetamolum+ Phenylephrini<br />

hydrochloridum+ Phenyramini<br />

maleas+Acidum ascorbicum<br />

powder for oral<br />

sol.<br />

4249. Pharmatex Benzalkonii chloridum vaginal ovules 18,9mg<br />

N10<br />

4250. Pharmatex Benzalkonii chloridum vaginal tab. 20mg<br />

N12<br />

500mg+10mg+20mg+<br />

50mg/sachet (23g)<br />

N10<br />

Pharmascience<br />

Innothera Laboratory<br />

Innothera Laboratory


EN<br />

308 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4251. Pharmatex Cream Benzalkonii chloridum vaginal cream 1,2g/100g<br />

72g<br />

4252. Pharmatex tampon Benzalkonii chloridum tampon 60mg<br />

N6<br />

Strength Manufacturer<br />

Innothera<br />

Innothera<br />

4253. Phenaemal 0,1 Phenobarbitalum tab. 100mg N50 Desitin<br />

4254. Phenaemaletten Phenobarbitalum tab. 15mg N50 Desitin<br />

4255. Phenhydan Phenytoinum tab. 100mg N50;N100; N200 Desitin<br />

4256. Phenhydan<br />

Infusionskonzentrat<br />

Phenytoinum conc. for sol.<br />

for inf.<br />

750mg/50ml N5 Pharma Hameln/<br />

Desitin<br />

4257. Phenhydan Injektionslosung Phenytoinum sol. for inj. 250mg/5ml amp.N5 Pharma Hameln/<br />

Desitin<br />

4258. Phensidrex-H tablet Reserpinum+ Dihydralazinum<br />

+ Hydrochlorothiazidum<br />

4259. Phezam Piracetamum+<br />

Cinnarizinum<br />

4260. Phlogenzym Rutosidum+<br />

Bromelaina+Trypsinum<br />

4261. Phosphonorm Aluminium-chloride-hydroxide<br />

complex (9:8:19)×23H2O<br />

4262. Phosphor-Homaccord Phosphorus D10+ Phosphorus<br />

D30+ Phosphorus D200+<br />

Argentum nitricum D10+<br />

Argentum nitricum D30+<br />

Argentum nitricum D200+<br />

Paris guadrifolia D6+ Paris<br />

guadrifolia D10+Paris<br />

guadrifolia D30+ Paris<br />

guadrifolia D200; (Ethanolum<br />

35vol.-%)<br />

tablets 0,1mg+10mg+10mg Nabros Pharma<br />

Private Limited<br />

caps. 400mg+25mg N60 Balkanpharma-<br />

Dupnitza<br />

enteric-coated<br />

tab.<br />

100mg+90mg+48mg N40;<br />

N200; N800<br />

caps. 300mg N100;N500 Medice<br />

drops 0,4g+0,4g+ 0,4g+0,3g+ 0,3g+<br />

0,3g+ 0,3g+0,3g+ 0,3g+<br />

0,3g/100g 30ml; 100ml<br />

4263. Phthalasolum Phthalysulfthiazolum tab. 0,5g N10; N20; N30; N50 Liuks<br />

4264. Physioneal 40 Glucose 1,36% /<br />

13,6mg/ml<br />

4265. Physioneal 40 Glucose 2,27% /<br />

22,7mg/ml<br />

4266. Physioneal 40 Glucose 3,86% /<br />

38,6mg/ml<br />

compos. solution for<br />

peritoneal<br />

dialysis<br />

compos. solution for<br />

peritoneal<br />

dialysis<br />

compos. solution for<br />

peritoneal<br />

dialysis<br />

4267. Physiotens 0,2 Moxonidinum film-coated tab. 0,2mg<br />

N28; N98<br />

4268. Physiotens 0,3 Moxonidinum film-coated tab. 0,3mg<br />

N28; N98<br />

4269. Physiotens 0,4 Moxonidinum film-coated tab. 0,4mg<br />

N28; N98<br />

4270. Phytodolor Ash bark (Populus tremula)+<br />

Aspen bark and leaves<br />

(Fraxinus excelsior)+ Natural<br />

golden rod herb (Solidago<br />

virgaurea); (Ethanol 45,6 %)<br />

Mucos Pharma<br />

Heel<br />

1,5l;2l;2,5l Baxter Healthcare<br />

S.A.<br />

1,5l;2l;2,5l Baxter Healthcare<br />

S.A.<br />

1,5l;2l;2,5l Baxter Healthcare<br />

S.A.<br />

oral sol. 20ml+60ml+20ml/100ml<br />

100ml; 200ml<br />

Solvay<br />

Pharmaceuticals<br />

Solvay<br />

Pharmaceuticals<br />

Solvay<br />

Pharmaceuticals<br />

Steigerwald


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 309<br />

No. Commercial name General name<br />

4271. Pikovit Retinolum+Cholecalciferolum+<br />

Acidum ascorbicum +<br />

Thiaminum+Riboflavinum+<br />

Pyridoxinum+<br />

Cyanocobalaminum+<br />

Nicotinamidum+Calcii<br />

pantothenas+Acidum folicum+<br />

Calcium+ Phosphorus<br />

4272. Pikovit (polivitaminu˛ sirupas<br />

vaikams)<br />

Retinolum+Cholecalciferolum+<br />

Acidum ascorbiccum+<br />

Thiaminum+Riboflavinum+<br />

Pyridoxinum+Cyanocobalaminum+<br />

Nicotinamidum+<br />

Dexpanthenolum<br />

4273. Pikovit D Retinolum+<br />

Cholecalciferolum+<br />

Acidum ascorbicum<br />

+Nicotinamidum<br />

+Calcii pantothenas<br />

+Riboflavinum+ Pyridoxinum+<br />

Thiaminum+ Acidum folicum+<br />

Cyanocobalaminum+Calcium+<br />

Phosphorus<br />

4274. Pikovit forte Retinolum+Cholecalciferolum+<br />

Acidum ascorbicum +<br />

Nicotinamidum+<br />

Tocopherolum+ Calcii<br />

pantthenas+ Pyridoxinum+<br />

Riboflavinum+ Thiaminum+<br />

Acidum folicum +<br />

Cyanocobalaminum<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

coated tab. 600 UI+80 UI +10mg+<br />

0,25mg+ 0,3mg+ 0,3mg+<br />

0,2µg+3mg+ 1,2mg+0,04mg+<br />

12,5mg+ 10mg<br />

N30<br />

sir. 900 UI+ 100UI+50mg +1mg+<br />

1mg+0,6mg+1µg+5mg+2mg/<br />

5ml<br />

150ml<br />

film-coated tab. 600UI+80UI+<br />

10mg+3mg+<br />

1,2mg+0,3mg+<br />

0,3mg+0,25mg<br />

0,04mg+0,2µg+12,5mg+<br />

10mg<br />

N30<br />

coated tab. 5000 UI+ 400 UI+ 60mg+<br />

20mg+15mg+ 10mg+2mg+<br />

1,7mg+ 1,5mg+ 0,4mg+6µg<br />

N30<br />

4275. Pilocarpin 2% Pilocarpinum eye drops 20mg/ml<br />

5ml N1; N2<br />

4276. Pilokarpino hidrochlorido<br />

1 % tirpalas<br />

4277. Pilokarpino hidrochlorido<br />

2 % tirpalas<br />

4278. Pilokarpino hidrochlorido<br />

1 % tirpalas<br />

KRKA<br />

KRKA<br />

KRKA<br />

KRKA<br />

Polfa Warsaw<br />

Pilocarpinum eye drops, sol. 100mg/10ml 10ml KMA vaistine˙<br />

Pilocarpinum eye drops, sol. 200mg/10ml 10ml KMA vaistine˙<br />

Pilocarpinum eye drops, sol. 15mg/1,5ml N10 Endokrininiai<br />

preparatai<br />

4279. Pilokarpin-V Unimed Pharma Pilocarpinum eye drops 20mg/ml 10ml Unimed Pharma<br />

4280. Pimidel Acidum pipemidicum caps. 200mg<br />

N20<br />

4281. Pinosol Ol.Pini silvestris+ Ol.Eucalypti+<br />

Thymolum+ Tocopherolum<br />

4282. Pinosol Ol.Pini silvestris+ Ol.Eucalypti+<br />

Thymolum+ Tocopherolum+<br />

Mentholum<br />

4283. Pinosol Pini aetheroleum+Menthae<br />

piperitae aetheroleum+<br />

Eucalypti aetheroleum +<br />

Thymolum+ Guaiazulenum+<br />

Tocopheroli acetas<br />

4284. Pipirinis pleistras Capsicum transdermal<br />

patch<br />

nasal cream 380mg+ 100mg+ 3,2mg+<br />

170mg/10g 10g<br />

nasal ointment 685mg+ 432,5mg+ 21,75mg+<br />

288,5mg+ 72,25mg/10g 10g<br />

nasal drops 375,2mg+ 100mg+50mg+<br />

3,2mg+ 2mg+170mg/10g<br />

10ml<br />

0,1mg/cm 2 (12cm × 8cm)<br />

N100<br />

KRKA<br />

Slovakofarma<br />

Slovakofarma<br />

Slovakofarma<br />

Kaigert


EN<br />

310 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4285. Pipirinis pleistras Capsicum transdermal<br />

patch<br />

Strength Manufacturer<br />

0,1mg/cm 2 (12cm × 16cm)<br />

N100<br />

4286. Pipirme˙te˙s lapai Fol. Menthae piperitae herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

4287. Pipirme˙te˙s lapai (smulkinti) Fol. Menthae piperitae Herbal tea 100g;50g;50g(2g×25); 16,8g<br />

(0,7g×24); 24g(1g×24);<br />

36g(1,5g×24); 48(2g×24).<br />

4288. Pipolphen Promethazinum coated tab. 25mg<br />

N25×20<br />

4289. Pipolphen Promethazinum sol. for inj. 25mg/ml<br />

2ml N10<br />

Kaigert<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

4290. Piracetam Piracetamum caps. 400mg N60 Polpharma<br />

4291. Piracetam-EGIS 400 mg Piracetamum film-coated tab. 400mg<br />

N60<br />

4292. Piracetam-EGIS 800 mg Piracetamum film-coated tab. 800mg<br />

N30<br />

4293. Piracetamo 1200 mg tablete˙s Piracetamum tab. 1200 mg N30; N60 Liuks<br />

4294. Piracetamo 20 % tirpalas<br />

injekcijoms<br />

Piracetamum sol. for inj. 200mg/ml 5ml amp. N10 Sanitas<br />

4295. Piracetamo 400 mg tablete˙s Piracetamum tab. 400 mg N30; N60 Liuks<br />

4296. Piracetamo 800 mg tablete˙s Piracetamum tab. 800 mg N30; N60 Liuks<br />

4297. Piracetams 200 mg Piracetamum coated tab. 200mg N120 OlainFarm<br />

4298. Piracetams 400 mg Piracetamum caps. 400mg N60 OlainFarm<br />

4299. Pirantelis Pyrantelum oral susp. 250mg/5ml 15ml Medana Pharma<br />

Terpol<br />

4300. Piridoksino hidrochloridas<br />

(Vitaminas B6) 10 mg<br />

4301. Piridoksino hidrochlorido<br />

(Vitamino B6) 5 % tirpalas<br />

injekcijoms<br />

4302. Piridoksino hidrochlorido<br />

(Vitamino B6) 5 % tirpalas<br />

injekcijoms<br />

4303. Piridoksino hidrochlorido<br />

(Vitamino B6) 5 % tirpalas<br />

injekcijoms<br />

4304. Piridoksino vandenilio<br />

chloridas<br />

4305. Piridoksino vandenilio<br />

chloridas<br />

4306. Piridoksino vandenilio<br />

chloridas 10 mg<br />

4307. Piridoksino vandenilio<br />

chloridas 5 mg<br />

Pyridoxinum tab. 10mg<br />

N50<br />

Egis<br />

Egis<br />

Egis<br />

Egis<br />

Sanitas<br />

Pyridoxinum sol. for inj. 50mg/ml amp. N10 Bakteriniai<br />

preparatai<br />

Pyridoxinum sol. for inj. 50mg/ml amp. 1ml Sanitas<br />

Pyridoxinum sol. for inj. 50mg/ml 1ml amp. N10 Endokrininiai<br />

preparatai<br />

Pyridoxinum tab. 50mg N10; N30; N50 Liuks<br />

Pyridoxinum tab. 10mg N10; N30; N50 Liuks<br />

Pyridoxini hydrochloridum tab. 10mg N30;N50 Bakteriniai<br />

preparatai<br />

Pyridoxini hydrochloridum tab. 5mg N30;N50 Bakteriniai<br />

preparatai<br />

4308. Piroksikamas Liuks Piroxicamum tab. 10 mg N10; N30 Liuks


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 311<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4309. Piroxicam Piroxicamum coated tab. 10mg<br />

N20<br />

4310. Piroxicam Piroxicamum coated tab. 20mg<br />

N20<br />

Strength Manufacturer<br />

4311. Piroxicam Piroxicamum gel 50mg/g 20g Glaxo Wellcome<br />

4312. Piroxicam 10 mg Piroxicamum supp. 10mg N10 Glaxo Wellcome<br />

4313. Piroxicam 20 mg Piroxicamum supp. 20mg N10 Glaxo Wellcome<br />

4314. Piroxicam 10 Stada Tabs Piroxicamum tab. 10mg N20;N50 Stada<br />

4315. Piroxicam 20 Stada Tabs Piroxicamum tab. 20mg<br />

N20; N50<br />

4316. PK — Merz Amantadinum film-coated tab. 100mg<br />

N30; N90<br />

Jelfa<br />

Jelfa<br />

Stada<br />

Ursapharm<br />

4317. PK — Merz Infusion Amantadinum sol. for inf. 200mg/500ml N2 Braun Melsungen<br />

4318. Plačialapio gysločio lapai Fol. Plantaganis majoris herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

4319. Plačialapiu˛ gysločiu˛ lapai<br />

(smulkinti)<br />

4320. Plantago-Homaccord Plant.major D2+ Plant.major<br />

D10+ Plant.major D15+<br />

Plant.major D30+ Plant.major<br />

D200 + Atr.belladonna D3+<br />

Atr.belladonna D10+<br />

Atr.belladonna D15 +<br />

Atr.belladonna D30+<br />

Atr.belladonna D200 +<br />

Atr.belladonna D1000+Ignatia<br />

D4+ Ignatia D10+Ignatia<br />

D30+Ignatia D200; Sp.aethyl.<br />

Folia Plantaginis majoris herbal tea 100g; 50g; 50(2g×25) Švenčioniu˛<br />

vaistazˇole˙s<br />

4321. Plaquenil Hydroxychloroquinum sugar coated<br />

tab.<br />

4322. Platidiam 10 inj. sicc. Cisplatinum powder for sol.<br />

for inf.<br />

4323. Platidiam 25 inj. sicc. Cisplatinum powder for sol.<br />

for inf.<br />

4324. Platidiam 50 inj. sicc. Cisplatinum powder for sol.<br />

for inf.<br />

drops 0,6g+0,6g+<br />

0,6g+0,6g+<br />

0,6g+0,2g+<br />

0,2g+0,2g+<br />

0,2g+0,2g+ 0,2g+0,2g+<br />

0,2g+0,2g+<br />

0,2g/ 100g; 35% (V/V)<br />

200mg<br />

N100<br />

4325. Plavix Clopidogrelum film-coated tab. 75mg<br />

N14; N28; N50<br />

4326. Plendil Felodipinum extended-release<br />

tab.<br />

4327. Plendil Felodipinum prolongedrelease<br />

tab.<br />

4328. Plendil Felodipinum prolongedrelease<br />

tab.<br />

Heel<br />

Sanofi Winthrop<br />

10mg/vial N10 Lachema<br />

25mg/vial N5 Lachema<br />

50mg/vial N1 Lachema<br />

2,5mg N100 Astra<br />

4329. Pleostat Acidum etidronicum tab. 400mg N14 KRKA<br />

4330. Plibex Nicotinamidum+Thiaminum+<br />

Riboflavinum+ Calcii<br />

pantothenas+ Pyridoxinum+<br />

Cyanocobalaminum<br />

5mg<br />

N30<br />

10mg<br />

N30<br />

film-coated tab. 25mg+5mg+5mg+5mg+ 2mg+<br />

1µg<br />

N30<br />

Sanofi Winthrop<br />

AstraZeneca<br />

AstraZeneca<br />

Pliva


EN<br />

312 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

4331. Pneumo 23 (single dose) Purified polysaccharides of<br />

Streptococcus pneumoniae (23<br />

serotypes)<br />

4332. Pnu-Imune 23 Serotypes of Streptococcus<br />

pneumoniae<br />

Pharmaceutical<br />

form<br />

sol. for inj. 25µg of each serotype/ 0,5ml<br />

pre-filled syringe N1<br />

sol. for inj.<br />

i.m.,s.c.<br />

Strength Manufacturer<br />

Pasteur Merieux<br />

25µg/0,5ml pre-filled syringe Cyanamid<br />

4333. Polcortolon Triamcinolonum cream 1mg/g 15g Jelfa<br />

4334. Polcortolon Triamcinolonum ointment 1mg/g 15g Jelfa<br />

4335. Polcortolon Triamcinolonum tab. 4mg N50 Polfa Pabianice<br />

4336. Polcortolon 10 Triamcinolonum microcrystalline<br />

susp. in vials<br />

4337. Polcortolon 40 Triamcinolonum microcrystalline<br />

susp. in vials<br />

4338. Polcortolon TC Tetracyclinum+<br />

Triamcinolonum<br />

10mg/ml<br />

N5<br />

40mg/ml<br />

N5<br />

aerosol 400mg+<br />

10mg/40g<br />

4339. Polfilin Pentoxifyllinum concentrate for<br />

sol. for inf.<br />

Jelfa<br />

Jelfa<br />

Polfa Tarchomin<br />

300mg/15ml N10 Polpharma<br />

4340. Polfilin Pentoxifyllinum sol. for inj. 100mg/5ml amp.N5 Polpharma<br />

4341. Polfilin retard Pentoxifyllinum coated tab. 400mg<br />

N20; N60<br />

4342. Polibiolinas (Polybiolinum) Proteinum ex plasma humani+<br />

Glucosum monohydricum<br />

4343. Polio Sabin Poliomyelitis vaccine, live<br />

attenuated: Type 1virus (strain<br />

LS-c,2ab)+Type 2 virus (strain<br />

P712,ch,2ab)+Type 3 virus<br />

(strain Leon 12a1b)<br />

4344. Poliodine Povidonum iodinatum<br />

(Polyvidonum)<br />

powder for<br />

injection<br />

Polpharma<br />

0,46g+0,11g Viešoji i˛staiga<br />

Vilniaus kraujo<br />

centras<br />

oral sol. > 10(6,0)CCID50+<br />

>10(5.0)CCID50+<br />

>10 (5.8)CCID50<br />

sol. for local<br />

application<br />

10g/100ml 45ml; 100ml;<br />

125ml; 250ml; 500ml;<br />

1000ml<br />

SmithKline Beecham<br />

4345. Polpressin Prazosinum tab. 2mg N30 Polpharma<br />

4346. Polpressin Prazosinum tab. 5mg N30 Polpharma<br />

4347. Polpressin Prazosinum tab. 1mg N30 Polpharma<br />

4348. Polygynax Neomycini sulfas+Polymyxini<br />

B sulfas+Nystatinum<br />

4349. Polygynax Virgo Neomycinum+ Polymyxinum<br />

B+ Nystatinum<br />

4350. Polyoxidonium (compositium<br />

pro formum medicinalium et<br />

vaccinum)<br />

4351. Populus compositum SR Populus tremuloides Ø+ Sabal<br />

serrulatum Ø+Capsicum<br />

annuum D3+ Bucco D3+<br />

Orthosiphon aristatum D3+<br />

Piper cubeba D3+ Camphora<br />

D3+ Apis mellifica D3+<br />

Solidago virgaurea D3+<br />

Serophularia nodosa D3+<br />

Ononis spinosa D3+<br />

Petroselinum crispum D3+<br />

Cucurbita pepo D3+Baptisia<br />

vaginal caps. 35 000 UI+35 000 UI+<br />

100 000 UI<br />

N6<br />

vaginal caps. 35000IU+ 35000IU+<br />

100000IU N6<br />

Gifrer<br />

Innothera Laboratory<br />

Innotech<br />

International<br />

Polyoxidonium subst. 50g Immapharma<br />

drops 10g+10g+ 3g+3g+3g+ 3g+3g+<br />

3g+ 3g+3g+3g+ 3g+3g+3g+<br />

3g+3g+3g+ 3g+3g+3g+ 3g+<br />

3g+ 3g/100g 30ml;<br />

100ml30ml; 100ml<br />

Heel


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 313<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4352. Portal capsules 20 mg Fluoxetinum caps. 20mg<br />

N14<br />

Strength Manufacturer<br />

4353. Postafen Meclozinum tab. 25mg N10; N100 UCB<br />

4354. Posterisan Standardized Bacterial Culture<br />

Suspension<br />

4355. Posterisan Standardized Bacterial Culture<br />

Suspension<br />

4356. Posterisan forte Standardized Bacterial Culture<br />

Suspension+Hydrocortisone<br />

4357. Posterisan forte Standradized Bacterial Culture<br />

Suspension+Hydrocortisone<br />

Lek<br />

ointment 166,7mg/g 25g Kade<br />

supp. 387,1mg N10 Kade<br />

ointment 166,7mg+ 2,5mg/g<br />

25g<br />

4358. Postinor Levonorgestrelum tab. 0,75mg<br />

N4<br />

Kade<br />

supp. 387,1mg+ 5mg N10 Kade<br />

Gedeon Richter<br />

4359. Postinor-2 Levonorgestrelum tablets 0,75mg N2 Gedeon Richter Ltd.<br />

4360. Potassium Chloride Kalii chloridum conc. for sol.<br />

for inf.<br />

4361. Potassium Chloride<br />

7,45 % Braun<br />

4362. Potassium Chloride<br />

7,45 % Braun<br />

4363. Potassium iodide 2 % Unimed<br />

Pharma<br />

4364. Prakaita˛ varantis vaistazˇoliu˛<br />

mišinys Nr.1<br />

4365. Prakaitavima˛ skatinantis<br />

vaistazˇoliu˛ mišinys Nr.3<br />

Kalii chloridum conc. for sol.<br />

for inf.<br />

Kalii chloridum conc. for sol.<br />

for inf.<br />

100mg/ml 100ml Ilsanta<br />

7,45g/100ml glass vials N20 Braun Melsungen<br />

1,5g/20ml plastic amp. N20 Braun Melsungen<br />

Kalii iodidum eye drops 20mg/ml 10ml Unimed Pharma<br />

Fruct. Rubi idaei+Flor. Tiliae herbal tea 50g+50g 100g;50g Švenčioniu˛<br />

vaistazˇole˙s<br />

Fol. Rubi idaei+Flor. Tiliae herbal tea 85g+15g 100g; 50g; 50g<br />

(2g×25)<br />

4366. Pramistar Pramiracetamum film-coated tab. 600mg<br />

N20<br />

4367. Prednisolon Prednisolonum tab. 5mg<br />

N20<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

F.I.R.M.A.<br />

Gedeon Richter<br />

4368. Prednisolon 0,5 % Prednisoloni acetas eye drops, susp. 5mg/ml 10ml Polfa Warsaw<br />

4369. Prednisolone Prednisolonum tab. 5mg N30 Polfa Pabianice<br />

4370. Prednisolon-ratiopharm 5<br />

Tabletten<br />

Prednisolonum tab. 5mg<br />

N30; N100<br />

4371. Prednizolonas Prednisoloni hemisuccinas for inj. dried 25mg<br />

5ml amp. N10<br />

4372. Preductal Trimetazidini<br />

dihydrochloridum<br />

4373. Preductal MR, modified-release<br />

film-coated tablet<br />

4374. Pregnyl<br />

5000 IU<br />

coated tab. 20mg<br />

N60<br />

Trimetazidinum modified-release<br />

film-coated<br />

tablets<br />

Gonadotrophinum<br />

chorionicum<br />

powder and<br />

solvent for inj.<br />

4375. Premandol Prednisolonum ointment 2,5mg/g<br />

20g; 100g<br />

Merckle<br />

Sanitas<br />

Servier<br />

35mg N60 Les Laboratoires<br />

Servier Industrie /<br />

Anpharm Sp.Akc.<br />

5000IU N(3amp.+ 3amp.) Organon<br />

Spirig Pharma


EN<br />

314 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4376. Premarin Conjugated estrogens tab. 0,625mg N28;84 Wyeth Medica<br />

4377. Premelle Conjugated estrogens+<br />

Medroxyprogesteronum<br />

4378. Premelle Cyklisk Conjugated estrogens;<br />

Conjugated estrogens+<br />

Medroxyprogesteronum<br />

4379. Premelle Sekvens Conjugated estrogens;<br />

Conjugated estrogens+<br />

Medroxyprogesteroni acetas<br />

4380. Premia 0,3mg/1,5mg Conjugated estrogens+<br />

Medroxyprogesteron<br />

4381. Premia 0,45mg/1,5mg Conjugated estrogens+<br />

Medroxyprogesteron<br />

4382. Premodal Almitrini bismesylas+<br />

Raubasinum<br />

4383. Prempac Conjugated estrogens;<br />

Medroxyprogesterone<br />

4384. Prempac Cyklisk Conjugated estrogens;<br />

Medroxyprogesterone<br />

4385. Prempac Sekvens Conjugated estrogens;<br />

Medroxyprogesterone<br />

tab. 0,625mg+ 5mg N84 Wyeth Medica<br />

tab. 0,625mg; 0,625mg+ 5mg<br />

N3×(14+14)<br />

tab. (I+II) 0,625mg; 0,625mg+<br />

-10mg N1× (14(I)+14(II));<br />

N3×(14(I)+14(II))<br />

Wyeth Medica<br />

Wyeth Medica/<br />

Wyeth Ayerst<br />

Canada/ Wyeth<br />

Ayrest Laboratories<br />

coated tablets 0,3mg+1,5mg N28;3×N28 Wyeth Medica<br />

Ireland<br />

coated tablets 0,45mg+ 1,5mg N28;3×N28 Wyeth Medica<br />

Ireland<br />

coated tab. 30mg+10mg N30 Servier<br />

4386. Prenacid Desonidum eye ointment 0,25g/100g<br />

10g<br />

tab. (I+II) 0,625mg; 5mg N 3×28(I+II) Wyeth Medica<br />

Ireland<br />

tab. (I+II) 0,625mg; 5mg N 3×(28+14) Wyeth Medica<br />

Ireland<br />

tab. (I+II) 0,625mg; 10mg N 3×(28+14) Wyeth Medica<br />

Ireland<br />

4387. Prenacid Desonidum eye drops 0,25g/100ml 10ml S.I.F.I.<br />

4388. Prenatal Vitamins & Minerals Retinol+Vit.D3+ Ascorbic<br />

acid+Tocopherol+Thiamine+<br />

Riboflavin+ Niacinamide+<br />

Pyridoxine+Cyanocobalamin+<br />

Folic acid+ Iron+Magnesium+<br />

Calcium+Iodine<br />

4389. Preparation H tepalas Mieliagrybiu˛ la˛steliu˛<br />

ekstraktas+Rykliu˛ kepenu˛<br />

aliejus<br />

4390. Preparation H zˇvakute˙s Mieliagrybiu˛ la˛steliu˛<br />

ekstraktas+Rykliu˛ kepenu˛<br />

aliejus<br />

4391. Presid 2,5 mg Felodipinum prolongedrelease<br />

tab<br />

4392. Presid 10 mg Felodipinum prolongedrelease<br />

tab.<br />

4393. Presid 5 mg Felodipinum prolongedrelease<br />

tab<br />

4394. Prestarium 4mg Perindoprili<br />

tertbutylaminum<br />

4395. Prevenar suspension for<br />

injection<br />

Pneumococcal saccharide<br />

conjugate vaccine, adsorbed<br />

tab. 8000IU+400IU+60mg+ 30IU+<br />

1,7mg+2mg+<br />

20mg+4mg+8µg+0,8mg+<br />

60mg+100mg+200mg+<br />

150µg N100<br />

ointment 1%+3%<br />

25g<br />

supp. 1%+3%<br />

N12<br />

tab. (scored<br />

tablets)<br />

2,5mg<br />

N30; N100<br />

10mg<br />

N30; N100<br />

5mg<br />

N30; N100<br />

4mg<br />

N30<br />

susp. for inj. 0,5ml vials; syringe+<br />

2 needles N1; N10<br />

S.I.F.I.<br />

Contract Pharmacal<br />

Wyeth<br />

Manufacturing<br />

Wyeth<br />

Manufacturing<br />

IVAX-CR/<br />

Omega Farma arba<br />

Kern Pharma<br />

IVAX-CR/<br />

Omega Farma arba<br />

Kern Pharma<br />

IVAX-CR/<br />

Omega Farma arba<br />

Kern Pharma<br />

Servier<br />

John Wyeth &<br />

Brothers


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 315<br />

No. Commercial name General name<br />

4396. Prevenar suspension for<br />

injection<br />

4397. Priešhemo-rojinis vaistazˇoliu˛<br />

mišinys ‘HEMORO-1’<br />

4398. Primacaine adrenaline<br />

1/100 000<br />

4399. Primacaine adrenaline<br />

1/200 000<br />

Pneumococcal saccharide<br />

conjugate vaccine, absorbed<br />

Sennae folium +Millefolii herba<br />

+Frangulae cortex+ Coriandri<br />

fructus<br />

Pharmaceutical<br />

form<br />

susp. for inj. 0,5ml pre-filled syringes;<br />

needles<br />

N1; N10<br />

herbal tea 25g+25g+ 25g+25g/ 100g<br />

37,5g (1,5g×25)<br />

Strength Manufacturer<br />

John Wyeth &<br />

Brothers<br />

Acorus Calamus<br />

Articainum+ Epinephrinum sol. for inj. 60,28mg+ 17µg/1,7ml N50 Produits Dentaires<br />

Pierre Roland<br />

Articainum+ Epinephrinum sol. for inj. 60,28mg+ 8,5µg/1,7ml N50 Produits Dentaires<br />

Pierre Roland<br />

4400. Prinivil Lisinoprilum tab. 20mg N28 MSD<br />

4401. Prinivil Lisinoprilum tabl. 5mg N28 MSD<br />

4402. Prinivil Lisinoprilum tab. 10mg N28 MSD<br />

4403. Priorix Live attenuated measles virus<br />

(Schwarz strain)+ Live<br />

attenuated mumps virus (RIT<br />

4385 strain)+ Live attenuated<br />

rubella virus (RA 27/3 strain)<br />

4404. Priorix (multidose) Live attenuated measles virus<br />

(Schwarz strain)+ Live<br />

attenuated mumps virus (RIT<br />

4385 strain)+ Live attenuated<br />

rubella virus (RA 27/3 strain)<br />

lyoph. tab. to<br />

be reconstituted<br />

with water for<br />

inj.<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

>=10×3.0 CCID50+ >=10×3.7<br />

CCID50+ >=10×3.0<br />

CCID50/0,5ml N1<br />

>10(3.0) CCID(50)+ >10(3.7)<br />

CCID(50)+ >10(3.0) CCID(50)<br />

N50<br />

4405. Pritor Telmisartanum tab. 40mg N14; N28; N56; N98;<br />

N280<br />

4406. Pritor Telmisartanum tab. 80mg N14; N28; N56; N98;<br />

N280<br />

4407. Pritor Telmisartanum tab. 20mg<br />

N28<br />

4408. Proalgin Metamizolum natricum tab. 500mg<br />

N20<br />

4409. Procto-Glyvenol Tribenosidum+ Lidocaini<br />

hydrochloridum<br />

SmithKline Beecham<br />

SmithKline Beecham<br />

Boehringer<br />

Ingelheim<br />

Boehringer<br />

Ingelheim<br />

Boehringer<br />

Ingelheim/Glaxo<br />

Wellcome<br />

Balkanpharma-<br />

Dupnitza<br />

supp. 400mg+ 40mg N10 Novartis Pharma<br />

4410. Procto-Glyvenol Tribenosidum+ Lidocainum rectal cream 50mg+ 20mg/g 30g Novartis Consumer<br />

4411. Prodeine 30 Paracetamolum+ Codeinum tab. 500mg+<br />

30mg N100<br />

Sanofi Winthrop<br />

4412. Prodeine 8 Paracetamolum+ Codeinum tab. 500mg+8mg N50 Sanofi Winthrop<br />

4413. Profamid Flutamidum tab. 250mg N84 Orion<br />

4414. Profasi 5000 Gonadotropinum chorionicum powder and<br />

solvent for sol.<br />

for inj.<br />

4415. Progynova Estradioli valeras suger-coated<br />

tab.<br />

5000IU/amp.+amp.of solvent<br />

(Sodium chloride isotonic<br />

1 ml) N1<br />

Serono<br />

2mg N21 Schering<br />

4416. Prokalmentas Ol. Propolisi+ Ol.Calendulae nasal drops 6g+ 4g/10ml 10ml;25ml;50ml KMU vaistine˙<br />

4417. Proleukin Aldesleukinum powder for<br />

sol.for inf.<br />

4418. Promentolis plius<br />

čiobrelis<br />

Propolis+Acidum ascorbicum+<br />

Thymi extr.+Mentholum extr.<br />

18MIU/vial<br />

N1<br />

tab. 7,5mg + 20mg +2mg+ 2mg;<br />

N20<br />

Chiron<br />

Medicata filia


EN<br />

316 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

4419. Promentolis plius<br />

eukaliptas<br />

Propolis + Acidum ascorbicum<br />

+ Eucalipti extr. + Mentholum<br />

extr.<br />

Pharmaceutical<br />

form<br />

4420. Pronoran Piribedilum sustainedrelease<br />

coated<br />

tab.<br />

4421. Prontoket spray Ketoprofenum sol.for topical<br />

use<br />

Strength Manufacturer<br />

tab. 7,5mg + 20mg + 2mg + 2mg;<br />

N20<br />

50mg<br />

N30<br />

4422. Propanorm 150mg Propafenoni hydrochloridum coated tab. 150mg<br />

N50<br />

Medicata filia<br />

Servier<br />

5g/100ml 50ml Medicom<br />

International<br />

4423. Propecia Finasteridum film-coated tab. 1mg N28 MSD<br />

4424. Propodezas Propolis+ Acidum ascorbicum tab. 33,7mg+ 50mg<br />

N30; N50<br />

4425. Propofol ‘Abbott’ Propofolum emuls. for inf. 10mg/ml<br />

20ml amp., 50ml.;100ml but.<br />

4426. Propofol 1% Fresenius Propofolum emulsion for<br />

injection/<br />

infusion<br />

4427. Propofol 2% Fresenius Propofolum emulsion for<br />

injection/<br />

infusion<br />

4428. Propolan Extr. Propolis conc. ad Spiritus<br />

aethylicus 96%<br />

4429. Propolan 4% Extr. Propolis conc. ointment 40mg/g<br />

20g<br />

1% 20ml amp.N5; 50ml vial<br />

N10; 100ml vial N10<br />

Pro. Med. CS Praha<br />

Bakteriniai<br />

preparatai<br />

Abbott<br />

Fresenius Kabi<br />

Austria GmbH<br />

2% 50ml vials N10 Fresenius Kabi<br />

Austria GmbH<br />

drops 4g ad 100g 20g Herbapol Wroclaw<br />

Herbapol Wroclaw<br />

4430. Propolanas MDF 4% Extr. Propolis conc. ointment 40mg/g 20g Medicata filia<br />

4431. Propolio skystas ekstraktas Propolis + Ethanolum 80% extractum<br />

fluidum<br />

4432. Propolio skystas ekstraktas<br />

MDF<br />

Propolis (Ethanolum<br />

80 %)<br />

300g +ad 1000g 30ml Sanitas<br />

extr. 300g (ad 1000ml) 30ml Medicata filia/<br />

Šeškine˙s vaistine˙<br />

4433. Propolio tinktūra Propolis + Ethanolum 80% tinct. 1g +ad 10ml 10ml; 30ml;<br />

50ml<br />

4434. Propolio tinktūra Propolis (Ethanolum<br />

80 %)<br />

Sanitas<br />

tinct. 100g (ad 1000ml) 25ml; 50ml KMU vaistine˙<br />

4435. Propolio tinktūros aerozolis Propolis + Ethanolum 80% aer. 100g +ad 1000ml 25ml; 50ml KMU vaistine˙<br />

4436. Propolis suppository Extr. Propolis supp. 75mg N10 Apipol<br />

4437. Propolis suppository MDF Extr. Propolis supp. 75mg N10 Medicata filia<br />

4438. Propolis Tinctura Extr. Propolis + Ethanolum aerosol 3g +ad 100g 20ml Apipol<br />

4439. Propolis Tinctura MDF Extr. Propolis + Ethanolum aerosol 3g +ad 100g 20ml Medicata filia<br />

4440. Propranolol Alpharma Tablets<br />

40 mg<br />

Propranololum film-coated tab. 40mg N28; N50 Alpharma<br />

4441. Proscar Finasteridum film-coated tab. 5mg<br />

N28<br />

4442. Prospan acute Hederae helicis folii extractum<br />

siccum<br />

4443. Prospan lašai Hederae helicis folii extractum<br />

siccum +Ethanolum 96%<br />

efferv. tabl. 65mg<br />

N10<br />

MSD<br />

Engelhard<br />

sol. 20mg+ 388mg/ml 20ml Engelhard


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 317<br />

No. Commercial name General name<br />

4444. Prospan sirupas nuo kosulio Hederae helicis folii extractum<br />

siccum<br />

Pharmaceutical<br />

form<br />

4445. Prostaherb N Extr. rad. Urticae sicc. drag. 230mg<br />

N40; N100<br />

4446. Prostamol uno Extr.Sabalis serrulatae (9,0-<br />

11,0:1)<br />

4447. Prostaphlin<br />

1 000 mg vial<br />

Strength Manufacturer<br />

syrup 7mg/ml 100ml Engelhard<br />

caps. 320mg<br />

N15; N30; N60<br />

Oxacillinum powder for inj. 1000mg<br />

N1; N50<br />

4448. Prostaphlin 250 mg Oxacillinum caps. 250mg<br />

N40<br />

4449. Prostaphlin 250 mg vial Oxacillinum powder for inj. 250mg<br />

N1; N50<br />

4450. Prostaphlin 500 mg Oxacillinum caps. 500mg<br />

N40<br />

4451. Prostaphlin 500 mg vial Oxacillinum powder for inj. 500mg<br />

N1; N50<br />

4452. Prostaplant Extr. fruct.Seronoa repes seu<br />

Sabali serrulatae (10-14,3:1)<br />

caps., soft 320mg<br />

N30<br />

4453. Prostato AC Serenoa Repens extr. caps. 160 mg<br />

N15; N30;N60<br />

4454. Prostavit (Prostavitas) Ol.Cucurbitae+ Sitosterolum+<br />

Extr.rad. Urticae+ Extr.rad.<br />

Echinaceae angustifolia+ Extr.<br />

fol. Orthosiphonis+ Extr. fruct.<br />

Sabalae+ Magnesii oxidum+<br />

Zinci orotas+ Acidum<br />

oroticum+ Tocoferolum<br />

4455. Prostawern Urtica Liquidum Urticae rad. extractum fluidum<br />

(1:1)<br />

caps. 428,5mg+ 60mg+ 100mg+<br />

20mg+ 50mg+ 2,5mg+<br />

66mg+ 23mg+ 10mg+ 10mg<br />

N40<br />

oral sol. 100g/100g (Ethanolum 30%)<br />

100ml<br />

4456. Prostenoon-Geel Dinoprostonum gel 2mg/3,5g single-dose syringe<br />

and catheter for application<br />

Redel<br />

Berlin-Chemie<br />

(Menarini Group)<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Dr.Willmar Schwabe<br />

Hasco-Lek/ Acorus<br />

calamus<br />

Arco-Chemie<br />

Wernigerode<br />

4457. Prostin E2 Dinoprostonum vaginal gel 1mg/3g Upjohn<br />

4458. Prostin E2 Dinoprostonum tab. 0,5mg Pharmacia & Upjohn<br />

4459. Prosulpin Sulpiridum tab. 200mg<br />

N30<br />

4460. Protamine Sulphate Leo Protamini sulfas sol. for inj. 10mg/ml<br />

5ml N1<br />

4461. Protaphane Flex Pen Insulinum humanum susp.for inj. 100 IU/ml 3ml cartridge+<br />

pre-filled pen with needle N5<br />

4462. Protaphane HM Penfill Isophanum insulinum susp. for inj. 100IU(3,5mg)/ml cartridge<br />

1,5ml N5<br />

4463. Protaphane HM Penfill Isophanum insulinum susp. for inj. 100IU(3,5mg)/ml cartridge<br />

3ml N5<br />

4464. Protaphane InnoLet Insulinum humanum<br />

recombinatum monocomponentum<br />

(Isophanum<br />

insulinum)<br />

susp. for inj. 100UI/ml uzˇpildytame švirkšte<br />

su 3ml cilindru N5<br />

Kevelt<br />

Pro. Med. Cs Praha<br />

Leo<br />

Novo Nordisk A/S<br />

Novo Nordisk<br />

Novo Nordisk<br />

Novo Nordisk<br />

4465. Protaphane NovoLet Insulinum humanum susp. for inj. 100IU/ml 3ml cartridge N5 Novo Nordisk


EN<br />

318 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

4466. Prothiazine Expectorant Promethazinum+<br />

Guaiphenesinum+ Ipecacuanha<br />

liquid extract<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

syrup 5mg+45mg+10mg/5ml 110ml CTS<br />

4467. Protradon Tramadoli hydrochloridum caps. 50mg N10;N20 Pro. Med. CS Praha<br />

4468. Provera Medroxyprogesteronum tab. 500mg<br />

N20<br />

4469. Provera Medroxyprogesteronum tab. 5mg<br />

N20<br />

4470. Provera Medroxyprogesteronum tab. 10mg<br />

N40<br />

4471. Provera Medroxyprogesteronum tab. 100mg<br />

N100<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

4472. Prozac Fluoxetinum disper-sible tab. 20mg N14; N28 Lilly Spain<br />

4473. Prozac Fluoxetinum caps. 20mg<br />

N14, N28<br />

Eli Lilly<br />

4474. Prozac Liquid Fluoxetinum oral sol. 20mg/5ml 70ml Lilly Spain<br />

4475. Prozac MR Fluoxetinum slow-release,<br />

gastro- resistant<br />

caps<br />

90mg<br />

N4<br />

4476. Psilo Balsam Diphenhydraminum gel 1g/100g<br />

20g; 50g<br />

4477. Psoriaten Mahonia aquifolium D1 ointment 1g/10g 50g;100g DHU<br />

4478. Psorigerb N Liquor Carbonis detergens+<br />

Urea pura+ Acidum<br />

salicylicum<br />

Eli Lilly<br />

Stada<br />

ointment 100mg+ 50mg+ 20mg/g 50g Redel<br />

4479. Psorimed Acidum salicylicum liquid 10g/100g 100ml Wolff<br />

4480. Psorinoheel Psorinum-Nosode D10+<br />

Medorrhinum-Nosode D12 +<br />

Sulfur D6+Thuja occidentalis<br />

D6+ Bufo bufo D10+<br />

Luesinum-Nosode D12+<br />

Natrium chloratum D12+<br />

Vaccininum-Nosode D8+<br />

Bismutum kalium iodidum<br />

D5+ Nerium oleander D4 +<br />

Cicuta virosa D5 +Bacillinum-<br />

Nosode D12 ad Sp. Aethyl.<br />

35%<br />

4481. Pulmicort 0,125 mg/ml Budesonidum susp. for<br />

nebulisation<br />

4482. Pulmicort 0,25 mg/ml Budesonidum susp. for<br />

nebulisation<br />

4483. Pulmicort 0,5 mg/ml Budesonidum susp. for<br />

nebulisation<br />

4484. Pulmicort Aerosol Budesonidum metered dose<br />

aerosol<br />

4485. Pulmicort Aerosol Budesonidum metered dose<br />

aerosol<br />

drops 10g+10g+10g+10g+<br />

10g+10g+10g+10g+5g+ 5g+<br />

5g+5g/100g<br />

Heel<br />

0,125mg/ml 2ml N20 Astra<br />

0,25mg/ml 2ml N20 AstraZeneca<br />

0,5mg/ml 2ml N20 AstraZeneca<br />

200µg/dose 10ml Astra<br />

50µg/dose 10ml Astra


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 319<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4486. Pulmicort Turbuhaler Budesonidum inhalation<br />

powder<br />

4487. Pulmicort Turbuhaler Budesonidum inhalation<br />

powder<br />

4488. Pulmicort Turbuhaler Budesonidum inhalation<br />

powder<br />

Strength Manufacturer<br />

200µg/dose 100 doses AstraZeneca<br />

100µg/dose 200 doses AstraZeneca<br />

400µg/dose 50 doses; 100<br />

doses; 200 doses<br />

4489. Pulmoclase Carbocisteinum caps. 375mg N50 UCB<br />

4490. Pulmoclase Carbocisteinum mixt. 50mg/ml 200ml; 500ml UCB<br />

AstraZeneca<br />

4491. Pulmoran compos. species, tea bags 1,5g every tea bag, N20 Leros Co.Ltd<br />

4492. Pulmozyme Dornasum alfa solution for<br />

inhalation<br />

4493. Pumpan Crataegus D1+ Arnica D6+<br />

Kalium carbonicum D6+<br />

Digitalis D12+ Convallaria<br />

D12+ Ethanolum 43%<br />

2 500U (2,5mg)/ 2,5ml amp.<br />

N6<br />

drops 20ml+10ml+10ml+10ml+<br />

10ml+40ml N20ml; N50ml;<br />

N100ml<br />

Genentech<br />

4494. Pupalaiškio lapai (smulkinti) Folia Menyanthidis trifoliatae herbal tea 50g; 50g(2g×25); 100g Švenčioniu˛<br />

vaistazˇole˙s<br />

4495. Pupeliu˛ ankštys (smulkintos) Valvae fructorum Phaseoli<br />

vulgaris<br />

Bittner<br />

herbal tea 50g;100g Švenčioniu˛<br />

vaistazˇole˙s<br />

4496. Puplaiškio lapai Fol. Menyanthidis trifoliatae herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

4497. Pure Skin Plus (Švari oda plius) Extr.Violae tricoloris+<br />

Extr.Bardanae+ Zincum+<br />

Extr.Echinaceae+ Extr. Urticae<br />

+Nicotinamidum+<br />

Chlorophyllum+ Biotinum<br />

4498. Puregon<br />

300 IU/0,36 ml<br />

4499. Puregon<br />

600 IU/0,72 ml<br />

caps., soft 100mg+50mg+7,5mg+<br />

30mg+25mg+10mg+ 10mg+<br />

0,1mg<br />

N60<br />

Follitropinum beta sol. for inj. 833 UI/ml 0,525ml cartridge<br />

N1<br />

Follitropinum beta sol. for inj. 833 UI/ml 0,885ml cartridge<br />

N1<br />

4500. Puregon Follitropinum beta powder and<br />

solvent for sol.<br />

for inj.<br />

4501. Puregon Follitropinum beta powder and<br />

solvent for sol.<br />

for inj.<br />

4502. Puregon Follitropinum beta powder and<br />

solvent for sol.<br />

for inj.<br />

4503. Puregon Follitropinum beta powder and<br />

solvent for sol.<br />

for inj.<br />

Arco-Chemie<br />

150 IU/amp. N1; N3; N5; N10 Organon<br />

100 IU/amp. N1; N3; N5; N10 Organon<br />

50 IU/amp. N1; N3; N5; N10 Organon<br />

75 IU/vial N1; N3; N5; N10 Organon<br />

Organon N.V./<br />

Organon (Ireland)<br />

Organon N.V./<br />

Organon (Ireland)<br />

4504. Puregon 100 IU/0,5 ml Follitropinum beta sol. for inj. 100 IU/0,5ml N1; N5; N10 Organon N.V./<br />

Organon (Ireland)<br />

4505. Puregon 150 IU/0,5 ml Follitropinum beta sol. for inj. 150 IU/0,5ml N1; N5; N10 Organon N.V./<br />

Organon (Ireland)<br />

4506. Puregon 50 IU/0,5 ml Follitropinum beta sol. for inj. 50 IU/0,5ml N1; N5; N10 Organon N.V./<br />

Organon (Ireland)


EN<br />

320 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4507. Puri-Nethol Mercaptopurinum tab. 50mg<br />

N25<br />

Strength Manufacturer<br />

Wellcome<br />

4508. Pušies pumpurai Gemm. Pini herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

4509. Pušies ūgliai Pini turiones herbal tea 50g Acorus Calamus<br />

4510. Pušu˛ pumpurai Gemm. Pini herbal tea 100g; 50g Švenčioniu˛<br />

vaistazˇole˙s<br />

4511. Pylorid 400 mg Ranitidinum bismuthum<br />

citratum<br />

film-coated tab. 400mg<br />

N28<br />

4512. Pyostacine Pristinamycinum coated scored<br />

tab.<br />

Glaxo Operations<br />

500mg (8000U/mg) N16 Rhone-Poulenc<br />

Rorer<br />

4513. Pyostacine Pristinamycinum coated tab. 250mg (8000U/mg) N16 Rhone-Poulenc<br />

Rorer<br />

4514. Pyrafat Pyrazinamidum film-coated tab. 500mg<br />

N50; N100<br />

4515. Pyrantel Pyrantelum tab. 250mg N3 Polpharma<br />

4516. Pyrazinamid Pyrazinamidum tab. 500mg N100 KRKA<br />

4517. Pyrazinamid Pyrazinamidum tab. 500mg N250 Farmapol<br />

4518. Pyrosal Extr. fluidum ex.:<br />

fol.Farfarae, flor.<br />

Sambuci, inf.Tiliae, cort.<br />

Salicis+conc. fruct. Ribis nigri+<br />

aroma fruct. Ribis nigri+<br />

Saccharum<br />

+Aqua<br />

syrup 10 parts+ 5 parts +<br />

0,5 parts+<br />

60 parts+<br />

24,5 parts 125g<br />

4519. Quadropril Spiraprilum tab. 6mg N30 AWD<br />

4520. Quamatel Famotidinum powder and<br />

solvent for sol.<br />

for inj.<br />

4521. Quamatel Famotidinum film-coated tab. 40mg<br />

N14<br />

4522. Quamatel Famotidinum film-coated tab. 20mg<br />

N28<br />

20mg/vial+ 5ml amp.of<br />

solvent N5<br />

Fatol<br />

Herbapol Wroclaw<br />

Gedeon Richter<br />

Gedeon Richter<br />

Gedeon Richter<br />

4523. Quietude compos. syrup 200ml Laboratoires Boiron<br />

4524. Quinoderm Cream 5 Benzoylis peroxidum+Kalii<br />

hydroxiquinolini sulfas<br />

4525. Quinoderm Cream Benzoylis peroxidum+Kalii<br />

hydroxiquinolini sulfas<br />

4526. Quinoderm Lotio-Gel 5 % Benzoylis peroxidum+Kalii<br />

hydroxiquinolini sulfas<br />

cream 5%+0,5% 50g Quinoderm<br />

cream 10%+0,5% 25g Quinoderm<br />

gel 5%+0,5% 30ml Quinoderm<br />

4527. Quintor Ciprofloxacinum sol. for inf. 200mg/ 100ml Torrent<br />

4528. Quintor-250 Ciprofloxacinum film-coated tab. 250mg N10 Torrent<br />

4529. Quintor-500 Ciprofloxacinum film-coated tab. 500mg N10 Torrent<br />

4530. Rabarbaru˛ tinktūra Rhei radix tinct. 100g Ethanolum ad 1 l 50 ml;<br />

100 ml<br />

Bakteriniai<br />

preparatai


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 321<br />

No. Commercial name General name<br />

4531. Rabipur Rabies Vaccine for human use<br />

PCEC<br />

Pharmaceutical<br />

form<br />

powder for sol.<br />

for inj.<br />

Strength Manufacturer<br />

>2,5IU/1ml one dose N1; N5;<br />

N30<br />

4532. Radedorm 5 Nitrazepamum tab. 5mg N20 AWD<br />

Chiron Behring<br />

4533. Radirex Rhei radix pulvis tab. 513,5mg N10 Herbapol Wroclaw<br />

4534. Rameval Valerianae radix+<br />

Leonuri herba+<br />

Lupuli strobulus+<br />

Menthae piperitae folium+<br />

Ethanolum 70 % (V/V)<br />

4535. Raminanti tinktūra Hyperici herba +Valerianae<br />

radix+Lupuli strob. (Ethanolum<br />

70%)<br />

tinct. (1:5) 60g+60g+<br />

40g+40g+ ad praeparationibus<br />

1l tincturae 30ml; 50ml<br />

tinct. 100g+100g+100g (q.s.ad<br />

1500g tincturae) 50ml<br />

4536. Ramune˙liu˛ ekstraktas Chamomillae flos extr. 1000 g Ethanolum ad 1 l<br />

25 ml, 50 ml,<br />

100 ml<br />

4537. Ramune˙liu˛ zˇiedynai Flor.Chamomillae 50g;100g;16,8g(0,7g×24);<br />

24g(1g×24); 36g(1,5g×24);<br />

48(2g×24).<br />

Bakteriniai<br />

preparatai<br />

Korio laboratorija<br />

Bakteriniai<br />

preparatai<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

4538. Raniberl 150 Ranitidinum film-coated tab. 150mg N20; N40; N50; N100 Berlin-Chemie<br />

4539. Raniberl 300 Ranitidinum film-coated tab. 300mg<br />

N20; N50<br />

4540. Ranigast Ranitidinum film-coated tab. 150mg<br />

N20; N60<br />

Berlin-Chemie<br />

(Menarini Group)<br />

Polpharma/<br />

Norfachema<br />

4541. Ranigast 75 Ranitidinum coated tab. 75mg N10 Polpharma<br />

4542. Ranisan Ranitidinum coated tab. 150mg N20 Pro. Med. CS Praha<br />

4543. Ranital Ranitidinum film-coated tab. 300mg N10; N30 Lek<br />

4544. Ranital Ranitidinum film-coated tab. 150mg N20; N30 Lek<br />

4545. Ranital Ranitidinum sol. for inj. 25mg/ml 2ml amp. N5 Lek<br />

4546. Ranitidin Ranitidinum tab. 300mg<br />

N20; N30<br />

4547. Ranitidin Ranitidinum tab. 150mg N20 KRKA<br />

4548. Ranitidine Alpharma tablets<br />

150 mg<br />

KRKA<br />

Ranitidinum film-coated tab. 150mg N30 Delta<br />

4549. Ranitidino 300 mg tablete˙s Ranitidinum tab. 300 mg N20, N30; N50; N60,<br />

N100<br />

4550. Ranitidino 150 mg tablete˙s Ranitidinum tab. 150 mg N20; N30; N50; N60;<br />

N100<br />

4551. Ranitidino 150 mg dengtos<br />

tablete˙s<br />

Liuks<br />

Liuks<br />

Ranitidinum tab. 150mg N50; N100 Sanitas/<br />

Chemo Iberica<br />

4552. Ranitidin-ratiopharm 150 Ranitidinum film-coated tab. 150mg<br />

N50<br />

4553. Ranitidin-ratiopharm 300 Ranitidinum film-coated tab. 300mg<br />

N50<br />

4554. Ranitidins 150mg Ranitidinum coated tab. 150mg<br />

N20<br />

Merckle<br />

Merckle<br />

OlainFarm


EN<br />

322 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4555. Ranitin Ranitidinum sol. for inj. 25mg/ml 2ml amp.N5 Torrent<br />

4556. Ranitin-150 Ranitidinum tab. 150mg N100 Torrent<br />

4557. Ranitin-300 Ranitidinum film-coated tab. 300mg N100 Torrent<br />

4558. Rapamune 1 mg Sirolimusum coated tab. 1mg<br />

N30; N100<br />

4559. Rapamune 1 mg/1 ml Sirolimusum oral sol. 1mg/ml (Ethanolum<br />

1,5%-2,5%) 1ml sachets N30<br />

4560. Rapamune 2 mg/2 ml Sirolimusum oral sol. 2mg/2ml (Ethanolum<br />

1,5%-2,5%) sachets N30<br />

4561. Rapamune5 mg/5 ml Sirolimusum oral sol. 5mg/5ml (Ethanolum<br />

1,5%-2,5%) sachets N30<br />

4562. Rapamune 1 mg/ml Sirolimusum oral sol. 1mg/ml (Ethanolum<br />

1,5%-2,5%) 60ml; 150ml<br />

bottles with 30 dosing syringes<br />

N1<br />

4563. Raphacholin C Raphani sativi nigri extractum<br />

siccum cum Carbo medicinalis<br />

(1:1)+Cynarae extractum<br />

spiss.+Acidum<br />

dehydrochloricum+ Menthae<br />

piperitae oleum<br />

4564. Rastocin Doxorubicinum powder for sol.<br />

for inj.<br />

drag. 150mg+<br />

47mg+40mg+15mg<br />

N30<br />

10mg/vial N10 Pliva<br />

Wyeth Laboratories<br />

Wyeth Medica<br />

Wyeth Medica<br />

Wyeth Medica<br />

Wyeth Medica<br />

Herbapol Wroclaw<br />

4565. Raudone˙lio zˇole˙ Herb. Origani vulgaris herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

4566. Raudone˙liu˛ zˇole˙ Origani herba herbal tea 100g; 50g; 50g(2g×25) Švenčioniu˛<br />

vaistazˇole˙s<br />

4567. Rausvazˇiedzˇiu˛ ezˇiuoliu˛<br />

urtinktūra<br />

Echinaceae purpureae herba<br />

(Ethanolum 86 %)<br />

urtinct. 1:1 50ml Korio laboratorija<br />

4568. Raxar Grepafloxacinum film-coated tab. 400mg N1; N2; N5; N7; N10 Glaxo Wellcome<br />

4569. Raxar Grepafloxacinum film-coated tab. 600mg N1; N2; N5; N7; N10 Glaxo Wellcome<br />

4570. Realdiron 5 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4571. Realdiron 9 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4572. Realdiron 6 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4573. Realdiron 18 000 000TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4574. Realdiron 1 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4575. Realdiron 6 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4576. Realdiron 10 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4577. Realdiron 3 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

for inj. dried 5000000MIU/amp. or vial<br />

N5<br />

Biotechna<br />

for inj. dried 9000000MIU/ amp. or vial N5 Biotechna<br />

for inj. dried 6 000 000 UI/vial N5 Biotechna<br />

for inj. dried 18 000 000 UI/amp. N5 Biotechna<br />

for inj. dried 1 000 000 UI/ vial N5 Biotechna<br />

for inj. dried 6 000 000 UI/amp. N5 Biotechna<br />

for inj. dried 10 000 000 UI/amp. N5 Biotechna<br />

for inj. dried 3 000 000 UI/amp.<br />

N1; N5<br />

Biotechna


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 323<br />

No. Commercial name General name<br />

4578. Realdiron 1 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4579. Realdiron 10 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4580. Realdiron 18 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4581. Realdiron 3 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4582. Realdiron set 6 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4583. Realdiron set<br />

18 000 000 TV<br />

Interferonum alfa-2b<br />

humanum recombinatum<br />

4584. Realdiron set 3 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4585. Realdiron set 1 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4586. Realdiron set 5 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4587. Realdiron set 9 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4588. Realdiron set 10 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

for inj. dried 1 000 000 UI/amp. N5 Biotechna<br />

for inj. dried 10 000 000 UI/ vial N5 Biotechna<br />

for inj. dried 18 000 000 UI/ vial N5 Biotechna<br />

for inj. dried 3 000 000 UI/ vial N5 Biotechna<br />

for inj. dried 6 000 000 UI/vial N1; N5 Biotechna<br />

for inj. dried 18 000 000 UI /vial N1; N5 Biotechna<br />

for inj. dried 3 000 000 UI/vial N1; N5 Biotechna<br />

for inj. dried 1 000 000 UI/vial N1; N5 Biotechna<br />

for inj. dried 5 000 000 UI/vial N1; N5 Biotechna<br />

for inj. dried 9 000 000 UI/vial N1; N5 Biotechna<br />

for inj. dried 10 000 000 UI/vial N1; N5 Biotechna<br />

4589. Rebetol Ribavirinum caps., hard 200mg N84; N140; N168 SP Labo<br />

4590. Rebif 22 µg Interferonum beta-1a sol. for inj. 22µg (6MIU)/ 0,5ml pre-filled<br />

syringe N1; N3;N12<br />

4591. Rebif 44 µg Interferonum<br />

beta-1a<br />

4592. Recofol Propofolum emulsion for<br />

i.v. inj.<br />

4593. Recombinate 1 000 IU Antihaemophilic factor VIII<br />

(recombinant)<br />

4594. Recombinate 250 IU Antihaemophilic factor VIII<br />

(recombinant)<br />

4595. Recombinate 500 IU Antihaemophilic factor VIII<br />

(recombinant)<br />

sol. for inj. 44µg/0,5ml pre-filled syringe<br />

N1;N3;N12<br />

powder and<br />

solvent for sol.<br />

for inf.<br />

powder and<br />

solvent for sol.<br />

for inf.<br />

powder and<br />

solvent for sol.<br />

for inf.<br />

4596. Recormon S 1 000 Epoetinum beta powder and<br />

solvent for sol.<br />

for inj.<br />

4597. Recormon S 2 000 Epoetinum beta powder and<br />

solvent for sol.<br />

for inj.<br />

10mg/ml 20ml N5; 50ml N1;<br />

100ml N1<br />

1000IU/bottle+10ml bottle of<br />

water for inj.+doubleended<br />

needle+18gauge needle+10ml<br />

single use syringe+1 mini-inf.set<br />

N1<br />

250IU/bottle+10ml bottle of<br />

water for inj.+double-ended<br />

needle+18gauge needle+10ml<br />

single use syringe+1 mini-inf.<br />

set N1<br />

500IU/bottle+10ml bottle of<br />

water for inj.+double-ended<br />

needle+18gauge needle+10ml<br />

single use syringe+1 mini-inf.<br />

set N1<br />

Serono/ Vetter<br />

Pharma/ Lab.Serono<br />

Serono/<br />

Vetter Pharma/<br />

Lab.Serono<br />

Leiras<br />

Baxter<br />

Baxter<br />

Baxter<br />

1000IU=8,3µg Boehringer<br />

Mannheim<br />

2000IU=16,6µg Boehringer<br />

Mannheim


EN<br />

324 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4598. Recormon S 5 000 Epoetinum beta powder and<br />

solvent for sol.<br />

for inj.<br />

4599. Recormon S 10 000 Epoetinum beta powder and<br />

solvent for sol.<br />

for inj.<br />

4600. Reductil Sibutramini hydrochloridum<br />

monohydricum<br />

4601. Reductil Sibutramini hydrochloridum<br />

monohydricum<br />

4602. Refergen 1 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4603. Refergen 1 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4604. Refergen 6 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4605. Refergen 10 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4606. Refergen 18 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4607. Refergen 18 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4608. Refergen 6 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4609. Refergen 10 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4610. Refergen 3 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4611. Refergen 3 000 000 TV Interferonum alfa-2b<br />

humanum recombinatum<br />

4612. Refisin Arsenicum album C5+<br />

Manganum aceticum C5+<br />

Kalium carbonicum D5+<br />

Arnica montana D5+Rhus<br />

toxicodendron D5<br />

4613. Refisin Arsenicum album C5+<br />

Manganum aceticum C5+<br />

Kalium carbonicum D5+<br />

Arnica montana D5+ Rhus<br />

toxicodendron D5<br />

4614. Reflin Cefazolinum sterilūs milteliai<br />

injekcijoms<br />

4615. Reflin Cefazolinum powder and<br />

solvent for sol.<br />

for inj.<br />

Strength Manufacturer<br />

5000IU=41,5µg Boehringer<br />

Mannheim<br />

10000IU=83µg Boehringer<br />

Mannheim<br />

caps. 10mg N28; N56; N98;<br />

N10×28<br />

caps. 15mg<br />

N28; N56; N98; N10×28<br />

Knoll<br />

Knoll<br />

for inj.dried 1000000 UI/amp. N5 Biotechna<br />

for inj.dried 1 000 000 UI/vial N5 Biotechna<br />

for inj. dried 6 000 000 UI/vial N5 Biotechna<br />

for inj.dried 10 000 000 UI/vial N5 Biotechna<br />

for inj. dried 18000000 UI/amp. N5 Biotechna<br />

for inj.dried 18 000 000 UI/vial N5 Biotechna<br />

for inj.dried 6000000 UI/amp. N5 Biotechna<br />

for inj. dried 10000000 UI/amp. N5 Biotechna<br />

for inj.dried 3000000 UI/amp. N5 Biotechna<br />

for inj.dried 3 000 000 UI/vial N5 Biotechna<br />

tab. 10mg+10mg+100mg+<br />

100mg+100mg/g<br />

N30; N50; N60<br />

oral drops 10mg+10mg+100mg+<br />

100mg+100mg/g<br />

20ml; 50ml<br />

Aconitum<br />

Aconitum<br />

1g/vial N50 Ranbaxy<br />

500 mg<br />

N1<br />

4616. Refortan Hydroxyethylamylum 200/0,5 sol. for inf. 60g/l<br />

250ml; 500ml<br />

4617. Refortan Plus Hydroxyethylamylum 200/0,5 sol. for inf. 100g/l<br />

250ml; 500ml<br />

Ranbaxy<br />

Berlin-Chemie<br />

Berlin-Chemie


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 325<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4618. Regaine Minoxidilum cutaneous sol. 20mg/ml (Ethanol 0,6ml)<br />

60ml bottle N1<br />

4619. Regaine Minoxidilum cutaneous sol. 50mg/ml (Ethanol 0,3ml)<br />

60ml bottle N1<br />

4620. Regla pH forte Aluminii oxidum hydricum+<br />

Magnesii hydroxidum+<br />

Aluminii hydroxidum et<br />

Magnesii carbonas<br />

praecipitatum<br />

chewable tab. 460mg+ 220mg+ 360mg<br />

N40<br />

4621. Reglan Metoclopramidum sol. for inj. 10mg/2ml<br />

N6; N12<br />

Strength Manufacturer<br />

Pharmacia N.V./S.A.<br />

Pharmacia N.V./S.A.<br />

UCB<br />

Synthelabo<br />

4622. Reglan Metoclopramidum tab. 10mg N40 Synthelabo<br />

4623. Reglan Metoclopramidum supp.<br />

(children)<br />

4624. Reglan Metoclopramidum supp.<br />

(adult)<br />

4625. Regranex Becaplermin gel 100µg/g 15g Cilag<br />

4626. Regulan (Regulanas) Extr.Sennae+Ol. Carum carvi+<br />

Ol. Foeniculi<br />

10mg<br />

N10<br />

20mg<br />

N10<br />

caps., soft 37,5mg+ 20mg+10mg<br />

N40<br />

Synthelabo<br />

Synthelabo<br />

Arco-Chemie<br />

4627. Regular Iletin II Insulinum suis sol. for inj. 100IU/ml 10ml Eli Lilly<br />

4628. Regulax Fol.Sennae+ Fruct.Sennae<br />

angustifolia<br />

fruit cubes 0,71g+0,3g N6; N12; N18 Krewel Meuselbach<br />

4629. Regulax Picosulphate Drops Natrii picosulfas oral drops,sol. 7,5mg/ml 10ml, 20ml, 50ml Krewel Meuselbach<br />

4630. Regulon Desogestrelum+<br />

Ethinylestradiolum<br />

film-coated tab. 0,15mg+ 0,03mg N21; N63 Gedeon Richter<br />

4631. Relanium Diazepamum sol. for inj. 10mg/2ml amp. N5;N10;N50 Polfa Warsaw<br />

4632. Relanium Diazepamum tab. 2mg<br />

N20<br />

4633. Relanium Diazepamum tab. 5mg<br />

N20<br />

4634. Relanium Diazepamum oral susp. 2mg/5ml (Ethanolum 95%<br />

400mg/ 100g) 100g<br />

4635. Relaxen N Extractum valerianae siccum<br />

(6,0-7,4:1)<br />

4636. Relenza Zanamivirum inhalation<br />

powder, predispensed<br />

4637. Relief Shark Liver Oil+ Phenylephrine<br />

hydrochloride<br />

Glaxo Wellcome<br />

Poznan<br />

Glaxo Wellcome<br />

Poznan<br />

Medana Pharma<br />

Terpol<br />

coated tablets 441,35mg N15;N30 Wiewelhove GmbH<br />

5mg/blister; 4blisters/Rotadisk<br />

N5; N7<br />

supp. 3%+0,25% N12 Perrigo<br />

4638. Relifex Nabumetonum film-coated tab. 500mg<br />

N20; N100<br />

4639. Relifex 1 g Nabumetonum dispersible<br />

tablet<br />

4640. Relium Diazepamum film-coated tab. 5mg<br />

N20<br />

Glaxo Wellcome<br />

SmithKline Beecham<br />

1 000mg N20; N100 SmithKline Beecham<br />

Polfa Tarchomin


EN<br />

326 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4641. Relium Diazepamum sol. for inj. 5mg/ml 2ml amp. N50 Polfa Tarchomin<br />

4642. Relpax 20 mg Eletriptanum film-coated tab. 20mg<br />

N2; N10; N30<br />

4643. Relpax 40 mg Eletriptanum film-coated tab. 40mg<br />

N2; N10; N30<br />

4644. Relpax 80 mg Eletriptanum film-coated tab 80mg<br />

N2; N10; N30<br />

4645. Remantadins 50 mg Rimantadinum tab. 50mg<br />

N20<br />

4646. Remens Cimicifuga D1+ Sanguinaria<br />

D6+ Aristolochia+Sepia D12+<br />

Lachesis D12<br />

4647. Remeron Mirtazapinum tab. 30mg<br />

N30<br />

4648. Remeron Mirtazapinum tab. 45mg<br />

N30<br />

4649. Remeron Mirtazapinum tab. 15mg<br />

N30<br />

4650. Remeron SolTab Mirtazapinum dispersible<br />

tablets<br />

4651. Remeron SolTab Mirtazapinum dispersible<br />

tablets<br />

drops, sol. 5ml+10ml+ 10ml+10ml+<br />

10ml/100ml (Ethanolum 43%)<br />

20ml; 50ml; 100ml<br />

Mack<br />

Mack<br />

Mack<br />

OlainFarm<br />

Bittner<br />

Organon/<br />

Riom Laboratoires-<br />

CERM<br />

Organon/<br />

Riom Laboratoires-<br />

CERM<br />

Organon/<br />

Riom Laboratoires-<br />

CERM<br />

15mg N30 Organon N.V<br />

30mg N30 Organon N.V.<br />

4652. Remestyp Terlipressinum sol. for inj. 0,2mg/2ml N5 Ferring-Lečiva<br />

4653. Remicade Infliximab powder for<br />

concentrate for<br />

sol. for inf.<br />

4654. Reminyl 12 mg Galantaminum film-coated tab. 12mg<br />

N56<br />

10mg/ml N1 Centocor<br />

Janssen-Cilag<br />

4655. Reminyl 4 mg/ml Galantaminum oral sol. 4mg/ml 100ml Janssen<br />

4656. Reminyl 4 mg Galantaminum film-coated tab. 4mg<br />

N14<br />

Janssen-Cilag<br />

4657. Reminyl 8 mg Galantaminum film-coated tab. 8mg N14;N56 Janssen-Cilag<br />

4658. Reneel Berberis vulgaris D2+ Acidum<br />

nitricum D4 + Cantharis D5 +<br />

Plumbum aceticum+Pareira<br />

brava D3+ Sabal serrulatum<br />

D2+ Causticum Hah-nemanni<br />

D4+ Aluminium oxydatum<br />

D12<br />

tab. 15mg+30mg+30mg+<br />

30mg+30mg+30mg+<br />

60mg+75mg<br />

4659. Renicin Roxithromycinum film-coated tab. 300mg N10 Lek<br />

4660. Renicin Roxithromycinum film-coated tab. 150mg N10 Lek<br />

4661. Renisan Calcii carbonas+<br />

Magnesii carbonas<br />

tab. 680 mg +<br />

80 mg<br />

4662. Renitec Enalaprilum tab. 20mg N28 MSD<br />

4663. Renitec Enalaprilum tab. 5mg N28 MSD<br />

Heel<br />

Sanitas


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 327<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4664. Renitec Enalaprilum tab. 10mg N28 MSD<br />

4665. Rennie Calcii carbonas+ Magnesii<br />

carbonas<br />

chewable tab. 680mg+80mg N24 Roche Nicholas<br />

4666. Reparil Gel N Escin+ Diethylamine salicylate gel 1g+5g/100g 40g; 100g Madaus<br />

4667. Requip 0,25 mg Ropinirolum film-coated tab. 0,25mg N210 SmithKline Beecham<br />

4668. Requip 1 mg Ropinirolum film-coated tab. 1mg<br />

N21<br />

4669. Requip 2 mg Ropinirolum film-coated tab. 2mg<br />

N21<br />

4670. Requip 5 mg Ropinirolum film-coated tab. 5mg<br />

N21<br />

4671. Resoma Somatropinum powder for sol.<br />

for inj.(+2ml<br />

cartridge of<br />

solvent02)<br />

4672. Resoma Somatropinum powder for sol.<br />

for inj. (+2ml<br />

cartridge of<br />

solvent)<br />

4673. Resoma Somatropinum powder for sol.<br />

for inj. +solvent<br />

(cartridge)<br />

4674. Resorban Camphora racemica+<br />

Cineolum+ Melaleucae<br />

viridiflorae aetheroleum<br />

SmithKline Beecham<br />

SmithKline Beecham<br />

SmithKline Beecham<br />

12 IU (4 mg) Sicor Biotech<br />

24 IU (8 mg) Sicor Biotech<br />

36 IU (12 mg) Sicor Biotech<br />

cream 100mg+70mg+30mg 30g Spirig<br />

4675. Resovist 0,5 mmol Fe/ml Ferucarbotran sol. for inj. 540mg/ml pre-filled syringe<br />

with 1,4ml and filter N1<br />

Schering<br />

4676. Resoxym Oxymetazolinum nasal drops, sol. 0,5mg/g 10ml ICN Polfa Rzeszow<br />

4677. Resoxym Oxymetazolinum nasal drops, sol. 0,1mg/g 10ml ICN Polfa Rzeszow<br />

4678. Resoxym Oxymetazolinum nasal drops, sol. 0,25mg/g 10ml ICN Polfa Rzeszow<br />

4679. Restin Acidum phosphoricum D5 +<br />

Zincum valerianicum D5+ Nux<br />

vomica D5+ Arsenicum album<br />

C5<br />

4680. Restin Acidum phosphoricum D5 +<br />

Zincum valerianicum D5 +Nux<br />

vomica D5+ Arsenicum album<br />

C5<br />

tab. 100mg+100mg+ 100mg+<br />

10mg/g<br />

N30; N50;<br />

N60<br />

oral drops 100mg+100mg+ 100mg+<br />

10mg/g<br />

20ml; 50ml<br />

4681. Retabolil Nandrolonum ol. sol. for inj. 50mg/ml<br />

1ml amp. N1<br />

4682. Retafyl 200 mg Theophyllinum controlledrelease<br />

tab.<br />

4683. Retafyl 300 mg Theophyllinum controlledrelease<br />

tab.<br />

4684. Retarpen 1,2 Vial Benzathini benzylpenicillinum powder for<br />

susp. for inj.<br />

4685. Retarpen 2,4 Vial Benzathini benzylpenicillinum powder for<br />

susp. for inj.<br />

Aconitum<br />

Aconitum<br />

200mg N100 Orion<br />

300mg N100 Orion<br />

Gedeon Richter<br />

1200000 IU/vial N100 Biochemie<br />

2400000 IU/vial N50 Biochemie


EN<br />

328 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4686. Retinolum acet. sol. ol. 3,44% Retinoli acetas sol. 3,44% 10ml Liuks<br />

4687. Retrovir Zidovudinum caps. 100mg N100 Wellcome<br />

4688. Retrovir Zidovudinum caps. 250mg<br />

N40; N100<br />

Wellcome<br />

4689. Reumador Piroxicamum gel 5mg/g 58g Slovakofarma<br />

4690. Revalid Methioninum+ Cystinum+<br />

Calcii pantothenas+<br />

Thiaminum+ Pyridoxinum+<br />

Ac. aminobenzoicum+<br />

Extr.Millii flavi+ Extr.Tritici<br />

germinis+ Faex medicinalis+<br />

Cuprum aminoshel+ Ferrum<br />

aminoshel+ Zincum aminoshel<br />

caps. 100mg+ 50mg+ 50mg+<br />

1,5mg+ 10mg+ 20mg+<br />

50mg+ 50mg+ 50mg+<br />

0,5mg+ 2mg+ 2mg N30<br />

4691. Revia Naltrexonum tab. 50mg N28; N50 Bristol-Myers Squibb<br />

4692. Revit Retinolum+Thiamini<br />

chloridum+Thiamini<br />

bromidum+Riboflavinum+<br />

Acidum ascorbicum<br />

drag. 2500IU+1mg+<br />

1,29mg+1mg+<br />

35mg<br />

N50<br />

4693. Revit Multivitamin caps., drag. N30; N50; N100 Liuks<br />

4694. Revital Garlic Pearls Garlic oil caps., soft 0,625mg<br />

N30<br />

4695. Rewma-Gel Rhus toxicodendron Ø +<br />

Symphytum ad usum<br />

externum Ø+Ledum Ø<br />

4696. Rewodina 50 Diclofenacum enteric-coated<br />

tab.<br />

4697. Rewodina Brausetablette 25mg Diclofenacum effervescent<br />

tablets<br />

4698. Rewodina Brausetablette 50mg Diclofenacum effervescent<br />

tablets<br />

4699. Rewodina retard Diclofenacum slow-release<br />

tab.<br />

Biogal<br />

Marbiofarm<br />

Ranbaxy<br />

gel 0,5g+1g+0,5g/10g 35g;50g DHU<br />

50mg N20; N50; N100 AWD<br />

25mg N10;N20 AWD. pharma<br />

GmbH & Co.KG<br />

50mg N10;N20 AWD. pharma<br />

GmbH & Co.KG<br />

100mg N20; N50; N100 AWD<br />

4700. Rexetin 20mg Paroxetinum tablets 20mg N30 Gedeon Richter Ltd.<br />

4701. Rezorcino etanolinis 1 %<br />

tirpalas<br />

Resorcinolum+ Ethanolum<br />

70%<br />

4702. Rheomacrodex 10 % Dextranum 40 +Natrii<br />

cloridum<br />

4703. Rheuma-Heel Rhus toxicodendron D6 +<br />

Bryonia cretica D4+ Causticum<br />

Hahnemanni D4+Arnica<br />

montana D4+ Ferrum<br />

phospho-ricum D6<br />

4704. Rhinathiol 2 % Children and<br />

Infants<br />

sol. 10g +ad 1000ml 40ml Vilniaus f.f.<br />

sol. for inf. 100g+9g/1000ml 400ml Ilsanta<br />

tab. 60mg+60mg+60mg+<br />

60mg+60mg<br />

Carbocisteinum syrup 100mg/5ml 100ml Synthelabo<br />

4705. Rhinathiol 5 % adults Carbocisteinum syrup 750mg/15ml 125ml Synthelabo<br />

4706. Rhinital Luffa operculata D4 +<br />

Galphimia glauca D3 +<br />

Cardiospermum D3<br />

tab. 25mg+25mg+25mg<br />

N100<br />

Heel<br />

DHU


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 329<br />

No. Commercial name General name<br />

4707. Rhinital Luffa operculata D4+<br />

Galphimia glauca D3+<br />

Cardiospermum D3<br />

Pharmaceutical<br />

form<br />

drops 10g+10g+10g/100g<br />

30ml<br />

Strength Manufacturer<br />

4708. Rhinocort Aqua Budesonidum nasal spray, sol. 32µg/dose 10ml (120 doses) AstraZeneca<br />

4709. Rhinocort Aqua Budesonidum nasal spray, sol. 64µg/dose 10ml (120 doses) AstraZeneca<br />

4710. Rhinocort Aqua Budesonidum nasal spray 50µg/dose 200 doses Astra<br />

4711. Rhinocort Aqua Budesonidum nasal spray 100µg/dose 200 doses Astra<br />

4712. Rhinopront Phenylpropanolaminum+<br />

Carbinoxaminum<br />

4713. Rhinopront Phenylephrini<br />

hydrochloridum+<br />

Carbinoxamini maleas<br />

4714. Rhino-Stas Nasenspray E Xylometazolinum nasal spray, sol. 1mg/ml<br />

10ml<br />

4715. Rhino-Stas Nasenspray E im<br />

Feindosierer<br />

Xylometazolinum nasal spray, sol. 1mg/ml<br />

10ml<br />

4716. Rhino-Stas Nasentropfen E Xylometazolinum nasal drops, sol. 1mg/ml<br />

10ml<br />

DHU<br />

syrup 300mg+ 24mg/100g Mack<br />

caps. 20mg+ 4mg N10; N20 Mack<br />

4717. Rhino-Stas Nasentropfen K Xylometazolinum nasal drops, sol. 0,5mg/ml 10ml Stada<br />

4718. Riboksinas Riboxinum tab. 0,2 g N50 Liuks<br />

4719. Ribomunyl Ribosomal fraction: Klebsiella<br />

pneumoniae, Steptococcus<br />

pneumoniae, Streptococcus<br />

pyogenes group A,<br />

haemophilus influenzae +<br />

Membrane fraction Klebsiella<br />

pneumoniae<br />

4720. Ribomunyl Ribosomal fraction: Klebsiella<br />

pneumoniae, Streptococcus<br />

pneumoniae, Streptococcus<br />

pyogenes group A,<br />

Haemophilis influenzae+<br />

Membrane fractions Klebsiella<br />

pneumoniae<br />

gran. for oral<br />

sol. in sachet<br />

3,5 parts, 3 parts, 3 parts, 0,5<br />

parts + 15 parts N4; N12; N20<br />

sachets (0,5g)<br />

tab. 3,5 parts, 3 parts, 3 parts, 0,5<br />

parts+ 15 parts 0,525g in<br />

ribosomal RNA N4; N12; N20<br />

Stada<br />

Stada<br />

Stada<br />

Progipharm<br />

Progipharm<br />

4721. Ricinu˛ aliejus Ricini oleum ol. 30ml; 50ml KMU vaistine˙<br />

4722. Ricinu˛ aliejus BP Ricini oleum oral sol. 30ml; 50ml; 100ml Bakteriniai<br />

preparatai<br />

4723. Rifamazide 150 Rifampicinum+Isoniazidum caps. 150mg+100mg N100 Polfa Tarchomin<br />

4724. Rifamazide 300 Rifampicinum+Isoniazidum caps. 300mg+150mg N100 Polfa Tarchomin<br />

4725. Rigevidon Ethinylestradiolum+<br />

Levonorgestrelum<br />

4726. Rigevidon coated tablets Ethinylestradiolum+<br />

Levonorgestrelum<br />

tab. 0,03mg+ 0,15mg<br />

N21; N3×21<br />

Gedeon Richter<br />

coated tab. 0,03mg+ 0,15mg N21;N3×21 Gedeon Richter<br />

4727. Rilutek Riluzolum film-coated tab. 50mg N56 Aventis Pharma<br />

(Nenagh)/Usiphar<br />

4728. Rimactane 150 Rifampicinum caps. 150mg N100 Novartis


EN<br />

330 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4729. Rimactane 300 Rifampicinum caps. 300mg N100 Novartis<br />

4730. Rinasol Calcium sulfuricum C6+<br />

Acidum silicicum C6+<br />

Kalium jodatum C6+<br />

Mercurium solubilis C6 +<br />

Aurum chloratum C6+<br />

Calcium fluoratum C6+<br />

Phytolacca americana C6+<br />

Atropa belladonna C6+<br />

Pulsatilla pratensis C6+<br />

Aconitum napellus C6+<br />

Delphinium staphisagria C6<br />

4731. Rinasol Calcium sulfuricum C5+<br />

Acidum silicicum C5<br />

Kalium jodatum C5 +<br />

Mercurium solubilis C5+<br />

Aurum chloratum C5+<br />

Calcium fluoratum C5+<br />

Phytolacca americanaC5+<br />

Atropa belladonna C5+<br />

Pulsatilla pratensis C5+<br />

Aconitum napellus C5+<br />

Delphinium staphisagria C5<br />

4732. Rindex 5 infusion Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum<br />

dihydricum+ Magnesii<br />

chloridum hexahydricum+<br />

Glucosum monohydricum<br />

4733. Ring N Acidum acetylsalicylicum+<br />

Coffeinum+ Acidum<br />

ascorbicum<br />

4734. Ringer Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum<br />

hexahydricum<br />

4735. Ringer Lactate Solution<br />

500 ml For Infusion<br />

Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum+<br />

Magnesii chloridum+ Natrii<br />

lactas<br />

4736. Ringer pro infusionibus Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum<br />

dihydricum<br />

4737. Ringer Solution<br />

500 ml for Infusion<br />

4738. Ringera laktata škidums<br />

infuzijam<br />

Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum<br />

Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum+<br />

Natrii lactas<br />

4739. Ringera Škidums Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum<br />

4740. Ringer-Acetate S5 infusion Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum<br />

dihydricum+ Magnesii<br />

chloridum hexahydricum+<br />

Natrii acetas trihydricum+<br />

Sorbitolum<br />

oral drops 1mg+1mg+1mg+1mg+<br />

1mg+1mg+1mg+1mg+<br />

1mg+1mg+1mg/g (Etanolum<br />

36 % (V/V)) 20ml<br />

tab. 10mg+10mg+10mg+ 10mg+<br />

10mg+ 10mg+<br />

10mg+10mg+10mg+<br />

10mg+10mg/g<br />

N30; N50; N60<br />

sol. for inf. 3,97g+ 0,26g+ 0,18g+ 0,2g+<br />

55g/1000ml 100ml; 500ml<br />

tab. 300mg+ 50mg+ 25mg N10;<br />

N20<br />

sol. for inf. 8,6g+ 0,3g+ 0,33g/1000ml<br />

500ml<br />

sol. for inf. 6g+400mg+<br />

101mg+ 94mg +<br />

3,03g/1000ml 500ml; 1000ml<br />

sol. for inf. 860mg+ 30mg+ 25mg/100ml<br />

500ml<br />

sol. for inf. 8,6mg+0,3g+ 0,33g/1000ml<br />

500ml<br />

sol. for inf. 6g+0,3g+ 0,15g+ 3,1g/1000ml<br />

500ml; 1000ml<br />

sol. for inf. 8,6g+0,3g+0,25g/1000ml<br />

(250ml; 500ml; 1000ml<br />

plastic bags with 3year<br />

shelf-life) 250ml; 500ml;<br />

1000ml ‘Propyflex’ with 2 year<br />

shelf-life<br />

sol. for inf. 3,97g+ 0,26g+ 0,18g+ 0,2g+<br />

6,12g+ 50g/1000ml 500ml<br />

Aconitum<br />

Aconitum<br />

Human<br />

Mack<br />

Human<br />

Ilsanta<br />

Balkanpharma-<br />

Troyan<br />

Ilsanta<br />

Grindeks<br />

Grindeks<br />

Human


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 331<br />

No. Commercial name General name<br />

4741. Ringerio acetato tirpalas<br />

infuzijoms<br />

Natrii chloridum+ Natrii<br />

acetas+ Kalii chloridum+ Calcii<br />

chloridum+ Magnesii<br />

chloridum<br />

4742. Ringer-Lactate Braun Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum<br />

dihydricum+ Natrii lactas<br />

4743. Ringer-Lactate Hartmann Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum<br />

dihydricum+ Natrii lactas<br />

4744. Ringer's Solution Braun Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum<br />

dihydricum<br />

4745. Rinodeks Pseudoephedrinum+<br />

Chlorphenaminum<br />

Pharmaceutical<br />

form<br />

intravenous inf. 5,9g+4,15g+0,3g+0,29g+<br />

0,2g/1000ml 100ml; 250ml;<br />

500ml; 1 000ml<br />

Strength Manufacturer<br />

sol. for inf. 6g+0,4g+0,27g+<br />

3,05g/1000ml 500ml; 1000ml<br />

sol. for inf. 6g+0,4g+ 0,27g+ 6,4g/1000ml<br />

500ml; 1000ml<br />

sol. for inf. 8,6g+0,3g+0,33g/1000ml<br />

250ml; 500ml; 1000ml<br />

syrup 600mg+40mg/<br />

100ml<br />

4746. Rinolan syrup Loratadinum syrup 5mg/5ml 100ml Pliva<br />

4747. Risaxyl Cholini salicylas+<br />

Xylometazolinum+<br />

Lidocainum<br />

4748. Rispen 1 Risperidonum film-coated<br />

tablets<br />

4749. Rispen 2 Risperidonum film-coated<br />

tablets<br />

4750. Rispen 3 Risperidonum film-coated<br />

tablets<br />

4751. Rispen 4 Risperidonum film-coated<br />

tablets<br />

nasal drops 200mg+5mg+<br />

25mg/10ml<br />

Ilsanta/ Fresenius<br />

Kabi Polska<br />

Braun Melsungen<br />

Human<br />

Braun Melsungen<br />

Grindex<br />

ICN Polfa Rzeszow<br />

1mg N20;N30;N50 Lečiva a.s.<br />

2mg N20;N30;N50 Lečiva a.s.<br />

3mg N20;N30;N50 Lečiva a.s.<br />

4mg N20;N30;N50 Lečiva a.s.<br />

4752. Rispolept Risperidonum oral sol. 1mg/ml 100ml Janssen<br />

4753. Rispolept Risperidonum film-coated tab. 1mg<br />

N20; N60<br />

4754. Rispolept Risperidonum film-coated tab. 2mg<br />

N20; N60<br />

4755. Rispolept Risperidonum film-coated tab. 3mg<br />

N20; N60<br />

4756. Rispolept Risperidonum film-coated tab. 4mg<br />

N20; N60<br />

4757. Risset Risperidonum film-coated<br />

tablets<br />

4758. Risset Risperidonum film-coated<br />

tablets<br />

4759. Risset Risperidonum film-coated<br />

tablets<br />

4760. Risset Risperidonum film-coated<br />

tablets<br />

Janssen<br />

Janssen<br />

Janssen<br />

Janssen<br />

4mg N20;N60 Pliva Pharmaceutical<br />

industry,<br />

Incorporated<br />

3mg N20;N60 Pliva Pharmaceutical<br />

industry,<br />

Incorporated<br />

2mg N20;N60 Pliva Pharmaceutical<br />

industry,<br />

Incorporated<br />

1mg N20;N60 Pliva Pharmaceutical<br />

industry,<br />

Incorporated


EN<br />

332 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

4761. Rivolox Aluminii hydroxidum+<br />

Magnesii hydroxidum<br />

Pharmaceutical<br />

form<br />

4762. Rivotril Clonazepamum tab. 2mg<br />

N30<br />

4763. Roaccutane Isotretinoinum caps. 10mg<br />

N30<br />

4764. Robitussin Antitussicum Dextromethorphani<br />

hydrobromidum<br />

Strength Manufacturer<br />

oral susp. 3,49g+ 3,99g/100ml 250ml Rivopharm<br />

Roche<br />

Roche<br />

sir. 7,5mg/5ml 100ml IVAX-CR<br />

4765. Robitussin Expectorans Guaifenesinum sir. 100mg/5ml 100ml IVAX-CR<br />

4766. Robitussin Junior Dextromethorphani<br />

hydrobromidum<br />

sir. 3,75mg/5ml 100ml IVAX-CR<br />

4767. Rocaltrol 0,5 µg Calcitriolum capsule, soft 0,5µg N30 Scherer<br />

4768. Rocaltrol 0,25 µg Calcitriolum capsule, soft 0,25µg N30 Scherer<br />

4769. Rocephin Ceftriaxonum powder for sol.<br />

for i.v./i.m. inj.<br />

4770. Roferon-A Interferonum<br />

alfa-2a<br />

4771. Roferon-A Interferonum<br />

alfa-2a<br />

4772. Roferon-A Interferonum<br />

alfa-2a<br />

4773. Roferon-A Interferonum<br />

alfa-2a<br />

solution for<br />

injection<br />

solution for<br />

injection<br />

solution for<br />

injection<br />

solution for<br />

injection<br />

4774. Rohypnol Flunitrazepamum film-coated tab.<br />

coloured<br />

formulation<br />

4775. Rouvax Live hyperattenuated measles<br />

virus SCHWARZ strain<br />

4776. Rouvax Live hyperattenuated measles<br />

virus SCHWARZ strain<br />

powder and<br />

solvent for<br />

susp. for inj.<br />

powder and<br />

solvent for<br />

susp. for inj.<br />

1g/vial N1 Roche<br />

3 million UI/ 0,5ml pre-filled<br />

syringe N1<br />

9 million UI/ 0,5ml pre-filled<br />

syringe N1<br />

6 million UI/ 0,5ml pre-filled<br />

syringe N1<br />

4,5 million UI /0,5ml pre-filled<br />

syringe N1<br />

Roche<br />

Roche<br />

Roche<br />

Roche<br />

1mg N30 Roche<br />

> 1 000 CCID 50/single dose<br />

vial+syringe of 0,5ml of<br />

solvent N1<br />

not less than 1000<br />

CCID50/vial (1vial-10doses)<br />

N10<br />

Pasteur Merieux<br />

Pasteur Merieux<br />

4777. Rovamycine Spiramycinum powder for inj. 1,5MIU N1 Rhone-Poulenc<br />

Rorer<br />

4778. Rovamycine Spiramycinum film-coated tab. 3MIU N10 Rhone-Poulenc<br />

Rorer<br />

4779. Rovamycine Spiramycinum film-coated tab. 1,5MIU N16 Rhone-Poulenc<br />

Rorer<br />

4780. Rovenal 100 Roxithromycinum film-coated<br />

tablets<br />

4781. Rovenal 150 Roxithromycinum film-coated<br />

tablets<br />

4782. Rovenal 300 Roxithromycinum film-coated<br />

tablets<br />

4783. Rowachol Pinenum+Camphenum+<br />

Cineolum+Mentholum+<br />

Menthonum+Borneolum<br />

100mg N10 Lečiva a.s.<br />

150mg N10,N14 Lečiva a.s.<br />

300mg N7 Lečiva a.s.<br />

caps.soft 17mg+5mg+2mg+32mg+<br />

6mg+5mg<br />

N50; N100<br />

Rowa<br />

Pharmaceuticals


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 333<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4784. Rowapraxin Pipoxolanum tab. 10mg N20 Rowa<br />

4785. Rowatinex Pinenum+Camphenum+<br />

Cineolum+Fenchonum+<br />

Borneolum+Anetholum<br />

caps.soft 31mg+15mg+<br />

3mg+4mg+<br />

10mg+4mg N50; N100<br />

Rowa<br />

Pharmaceuticals<br />

4786. Rozex Cream Metronidazolum cream 0,75g/100g 15g; 30g Laboratoires<br />

Galderma<br />

4787. Rozex Gel Metronidazolum gel 0,75g/100g 15g; 30g; 50g Laboratoires<br />

Galderma<br />

4788. Rub-Arom Mentholum+ Camphora+<br />

Ol.Terebinthinae+Ol.<br />

Eucalipti+ Ol.Cedri+<br />

Thymolum<br />

4789. Rudivax Live attenuated rubella<br />

virus,WISTAR RA 27/3M<br />

strain<br />

4790. Rudivax Live attenuated rubella virus<br />

WISTAR RA 27/3M strain<br />

ointment 2,75g+5g+ 5g+1,5g+ 0,75g+<br />

0,25g/100g 40g<br />

powder and<br />

solvent for<br />

susp. for inj.<br />

powder and<br />

solvent for<br />

susp. for inj.<br />

not less 1000 CCID50/single<br />

dose vial+syringe of 0,5ml of<br />

solvent N1<br />

not less than 1000<br />

CCID50/vial (1 vial-10doses-5ml)<br />

N10<br />

4791. Rudotel Medazepamum tab. 10mg N20;N50 AWD<br />

4792. Rūgčiu˛ gyvatzˇoliu˛<br />

šakniastiebiai<br />

4793. Rūgčiu˛ takazˇoliu˛ zˇole˙<br />

(smulkinta)<br />

Hasco-Lek<br />

Pasteur Merieux<br />

Pasteur Merieux<br />

Rhiz. Bistortae herbal tea 50g Švenčioniu˛<br />

vaistazˇole˙s<br />

Herba Polygoni avicularis herbal tea 100g; 50g; 50g(2g×25);<br />

25g(1g×25); 16,8g(0,7g× 24);<br />

24g(1g×24); 36g(1,5g×24);<br />

48g(2g×24).<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

4794. Rugiage˙le˙s zˇiedai Flor. Cyani herbal tea 25×1,5g Acorus Calamus<br />

4795. Rūgties takazˇole˙s zˇole˙ Herb. Polygoni avicularis herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

4796. Rutacid Hydrotalcitum chewable tab. 500mg N20;N30 KRKA<br />

4797. Rutinosan C Acidum ascorbicum+<br />

Rutinum<br />

4798. Rutinoscorbin Rutosidum+ Acidum<br />

ascorbicum<br />

tab. 50 mg+50 mg Sanitas<br />

coated tab. 25mg+100mg N30 Glaxo Wellcome<br />

4799. Rykštene˙s zˇole˙ Herb. Virgaureae herbal tea N25 po 1,5g; 50g Acorus Calamus<br />

4800. Rytmonorm Propafenonum film-coated tab. 300mg<br />

N20; N50; N100<br />

4801. Rytmonorm 150 mg Propafenonum film-coated tab. 150mg<br />

N20; N50; N100<br />

4802. Rytmonorm injection solution Propafenonum sol. for inj. 70mg/20 ml amp. N5 Knoll<br />

4803. sab simplex Simeticonum oral susp. 69,19mg/ml 30ml Parke-Davis<br />

4804. Sabal-Homaccord Sabal serrulatum Ø+Sabal<br />

serrulatum D10+ Sabal<br />

serrulatum D30+Hepar sulfuris<br />

D10+ Hepar sulfuris D15+<br />

Hepar sulfuris D30 +Hepar<br />

sulfuris D200 (Ethanolum<br />

45%)<br />

drops 0,9g+0,3g+ 0,3g+0,7g+ 0,7g+<br />

0,7g+ 0,7g/100g 30ml; 100ml<br />

Knoll<br />

Knoll<br />

Heel


EN<br />

334 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4805. Sabrilex Vigabatrinum film-coated tab. 500mg<br />

N100<br />

4806. Saizen 24 IU (8mg) Easyject Somatropinum powder and<br />

solvent for sol.<br />

for inj.<br />

4807. Salamol Easi-Breathe Salbutamolum aerosol for<br />

inhal., susp.<br />

4808. Salamol Inhaler Salbutamolum pressurised<br />

inhalation, sol.<br />

Strength Manufacturer<br />

24IU (8mg) N1;N5 Serono<br />

0,1mg/dose 200doses;<br />

3×200doses<br />

Marion Merrell<br />

Bourgoin<br />

Galena<br />

100µg/dose 200 doses IVAX-CR/Norton<br />

(Waterford)<br />

4809. Šalavijo lapai Fol. Salviae herbal tea 50g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

4810. Šalaviju˛ lapai (smulkinti) Folia Salviae herbal tea 50g; 50g (2g×25); 16,8g<br />

(0,7g×24); 24g (1g×24); 36g<br />

(1,5g×24); 48g (2g×24).<br />

4811. Šalaviju˛ tinktūra Salviae folia tinct. 200 g Ethanolum ad 1 l 50 ml;<br />

100 ml<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Bakteriniai<br />

preparatai<br />

4812. Šalaviju˛ tinktūra (1:5) Salviae officinalis folium liquid 50ml;100ml Bakteriniai<br />

preparatai AB<br />

4813. Salazopyrin EN-tabs Sulfasalazinum tab. 500mg<br />

N100<br />

4814. Salbutamol Salbutamolum tab. 2mg<br />

N30<br />

4815. Salbutamol Salbutamolum tab. 4mg<br />

N30<br />

4816. Salbutamol Salbutamolum metered dose<br />

aerosol<br />

4817. Salbutamol ‘Nycomed’ Salbutamolum metered dose<br />

aerosol<br />

4818. Salbutamol Stada Salbutamolum metered dose<br />

inhaler<br />

4819. Salicilo rūgšties 5 % tepalas Acidum salicylicum ointment 5g/100g<br />

30g<br />

4820. Salicilo rūgšties 1 % etanolinis<br />

tirpalas<br />

4821. Salicilo rūgšties etanolinis<br />

1 % tirpalas<br />

4822. Salicilo rūgšties etanolinis 1%<br />

tirpalas<br />

Acidum salicylicum +<br />

Ethanolum 70%<br />

Pharmacia AB<br />

Polfa Warsaw<br />

Polfa Warsaw<br />

100µg/dose 200 doses Glaxo Wellcome<br />

100µg/dose 21g (300doses) IG-Spruh-technik<br />

0,1mg/ 0,05ml 300 doses IG Spruh-technik/<br />

Stada<br />

KMU vaistine˙<br />

sol. 10g +ad 1000ml 40ml Bakteriniai<br />

preparatai<br />

laboratorija Galen<br />

Acidum salicylicum sol. 10g/ml (Ethanolum 70% ad 1l)<br />

40ml; 80ml<br />

Acidum salicylicum ad<br />

Ethanolum 70%<br />

Vilniaus f.f.<br />

sol. 10g ad 1000ml 40ml Bakteriniai<br />

preparatai<br />

4823. Salipax Fluoxetinum caps. 20mg N10; N30 Mepha<br />

4824. Salofalk 250 Mesalazinum enteric-coated<br />

tab.<br />

250mg N50 Ebulon/ Losan/ Falk<br />

4825. Salofalk 250 Mesalazinum supp. 250mg N30 Serumwerk/ Falk<br />

4826. Salofalk 500 Mesalazinum enteric-coated<br />

tab.<br />

500mg N50 Ebulon/ Losan/ Falk<br />

4827. Salofalk 500 Mesalazinum supp. 500mg N30 Serumwerk/ Falk


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 335<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4828. Salofalk enemas Mesalazinum enema 4g/60ml 5g.,150g 300g Falk<br />

4829. Šaltalankiu˛ aliejinis ekstraktas Extr. Hippophaes oleosa<br />

concentratum+ Ol.Helianthi<br />

ol. extr. 50g/100g 25ml;50ml;<br />

100ml<br />

KMU vaistine˙<br />

4830. Šaltekšnio zˇieve˙ Cort. Frangulae tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

4831. Salts Solution 250 ml for<br />

Irrigation<br />

Natrii chloridum+ Kalii<br />

chloridum+ Calcii chloridum+<br />

Magnesii chloridum+ Natrii<br />

acetas+Natrii citras<br />

irrigation sol. 6,4g+0,75g+0,48g+0,3g+<br />

3,94g+1,76g/ 1000ml 250ml<br />

4832. Salvia fix Salvia officinalis folium herbal tea 1,2g/sachets N20 Herba Humana<br />

4833. Sananginas Magnesii aspartas+ Kalii<br />

aspartas<br />

4834. Sandimmun Neoral Ciclosporinum caps., soft 25mg<br />

N50<br />

4835. Sandimmun Neoral Ciclosporinum caps., soft 50mg<br />

N50<br />

4836. Sandimmun Neoral Ciclosporinum caps., soft 100mg<br />

N50<br />

4837. Sandimmun Neoral<br />

100 mg/ml<br />

Ilsanta<br />

sol. for inj. 400mg+ 452mg/10ml amp.N5 Sanitas<br />

Novartis Pharma<br />

Novartis Pharma<br />

Novartis Pharma<br />

Ciclosporinum oral sol. 100mg/ml 50ml Novartis Pharma<br />

4838. Sandostatin Octreotidum sol. for inj. 0,1mg/ml<br />

1ml amp. N5<br />

4839. Sandostatin LAR 10 mg Octreotidum powder and<br />

solvent for<br />

susp.for inj.<br />

4840. Sandostatin LAR 20 mg Octreotidum powder and<br />

solvent for<br />

susp.for inj.<br />

4841. Sanficinate Calcii folinas powder for sol.<br />

for inj.<br />

4842. Sanficinate Calcii folinas powder for sol.<br />

for inj.<br />

4843. Sanficinate Calcii folinas powder for sol.<br />

for inj.<br />

4844. Sanhelios Baldrian+ Hopfen<br />

Dragees S<br />

4845. Sanhelios Bornin Johanniskraut<br />

CC<br />

Extr. Valerianae ex rad. spir.<br />

sicc.+ Extr.Humuli lupuli ex<br />

strob.spir.sicc.<br />

Extr. Hyperici ex herbae cum<br />

floribus siccum<br />

10mg/vial+2amp.of solvent+<br />

inj.-set N1<br />

20mg/vial+2amp.of solvent+1<br />

inj.-set N1<br />

350mg N1 Sterilyo<br />

200mg N1 Sterilyo<br />

100mg N1 Sterilyo<br />

dragees 68mg+16mg N96 Borner<br />

dragees 200mg<br />

N48<br />

4846. Sanipril Enalaprili maleates tab. 2,5mg Sanitas<br />

4847. Sanipril Enalaprili maleates tab. 5mg Sanitas<br />

4848. Sanipril Enalaprili maleates tab. 10mg Sanitas<br />

4849. Sanipril Enalaprili maleates tab. 20mg Sanitas<br />

4850. Sanipril Enalaprili maleates sol. for<br />

injections<br />

Novartis Pharma<br />

Nycomed Austria<br />

Novartis Pharma<br />

Borner<br />

1,25mg Sanitas


EN<br />

336 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

4851. Sanipril H Enalaprili maleates +<br />

Hydrochlothiazidum<br />

4852. Sanipril HL 20 Enalaprili maleates+<br />

Hydrochlothiazidum<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

tab. 10mg+25mg Sanitas<br />

tab. 20mg+ 12,5mg Sanitas<br />

4853. Sanivit A+E Carotenum+Tocopherolum caps. 30 000IU + 70mg Sanitas<br />

4854. Sanivit C Ascorbic acid+<br />

Sodium ascorbate<br />

4855. Sanivit Trio ACE b-Carotenum+ Acidum<br />

ascorbicum +Tocopherolum +<br />

Selenium<br />

chewable<br />

tablets<br />

80mg+<br />

136.4mg<br />

caps. 10mg+40mg+ 100mg+<br />

50mcg<br />

4856. Sanorin Naphazolinum nasal drops, sol. 5mg/10ml IVAX-CR<br />

4857. Sanorin Naphazolinum nasal drops, sol. 10mg/10ml IVAX-CR<br />

4858. Sanorin Naphazolini nitras nasal drops,<br />

emulsion<br />

Sanitas<br />

Sanitas<br />

10mg/10ml 10ml IVAX-CR<br />

4859. Sanorin-Analergin Naphazolinum+ Antazolinum nasal/ eye drops 0,25mg+ 5mg/ml 10ml IVAX-CR<br />

4860. Santramal Tramadolum tab. 50mg Sanitas<br />

4861. Santramal Tramadolum caps. 50mg Sanitas<br />

4862. Saridon Paracetamolum+<br />

Propyphenazonum+<br />

Coffeinum<br />

tab. 250mg+150mg+50mg<br />

N10<br />

4863. Saroten Amitriptylinum film-coated tab. 10mg<br />

N100<br />

4864. Saroten Amitriptylinum film-coated tab. 25mg<br />

N100<br />

4865. Saroten Retard Amitriptylinum modified-release<br />

caps.<br />

4866. Sausas bifidumbakterinas Bifidobacterium bifidum I lyophilized<br />

mass<br />

4867. Sausas bifikolis Bifidobacterium bifidum I+<br />

Escherichia coli M-17<br />

4868. Sausas histaglobulinas Immunoglobulinum<br />

humanum+Histamini<br />

dihydrochloridum<br />

lyophilized<br />

mass<br />

4869. Sausas laktobakterinas Lactobacillus plantarum 8P-A3 lyophilized<br />

mass<br />

4870. Sausas leukocitinis zˇmogaus<br />

interferonas<br />

Interferonum leucocyticum<br />

humanum siccum<br />

50mg<br />

N100<br />

Roche<br />

Lundbeck<br />

Lundbeck<br />

Lundbeck<br />

10mlrd./ dose 3 or 5 doses Bakteriniai<br />

preparatai<br />

10mlrd.+ 10mlrd./ dose 3 or 5<br />

doses<br />

Bakteriniai<br />

preparatai<br />

powder for inj. 12mg+0,2µg/amp. N10 Vilniaus kraujo<br />

centras<br />

lyophilized<br />

powder<br />

2-4 mlrd./dose 5 doses Bakteriniai<br />

preparatai<br />

1000 IU/amp. N10 Bakteriniai<br />

preparatai<br />

4871. Scandonest 2 % special Mepivacainum+ Epinephrinum sol. for inj. 36mg+18µg/carpules (1,8ml)<br />

N50<br />

Septodont<br />

4872. Scandonest 3 % plain Mepivacainum sol. for inj. 54mg/ carpules (1,8ml) N50 Septodont<br />

4873. Schwef-Heel Sulfur D4+D6+<br />

D12+D30+D200; Ethanolum<br />

85%<br />

4874. Sebidin Chlorhexidinum+<br />

Acidum ascorbicum<br />

drops 20g+20g+20g+20g+20g/<br />

100g 30ml; 100ml<br />

Heel<br />

tab. 5mg+50mg N20 Polfa Poznan


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 337<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4875. Sedacoron 150 mg Amiodaroni hydrochloridum concentrate for<br />

sol. for inf.<br />

Strength Manufacturer<br />

150mg/3ml amp. N5 Ebewe<br />

4876. Sedacoron 200 mg Amiodaroni hydrochloridum tab. 200mg N50 Ebewe<br />

4877. Sedariston mono<br />

350 mg (Aristo (350)<br />

Extr. Hypericum (Jonazˇole˙s<br />

sausas ekstraktas)<br />

4878. Sedatif PC Aconitum napellus 6 CH+<br />

Belladonna 6 CH+ Calendula<br />

officinalis 6 CH+<br />

Chelidonium majus 6 CH+<br />

Abrus precatorius 6 CH+<br />

Viburnum opulus 6CH<br />

caps. N30; N60; N100 Liuks<br />

tab. 0,5mg+0,5mg+0,5mg+<br />

0,5mg+0,5mg+0,5mg N40<br />

4879. Seduxen Diazepamum tab. 5mg<br />

N20<br />

Boiron<br />

Gedeon Richter<br />

4880. Seduxen Diazepamum sol. for inj. 5mg/ml 2ml amp. N5 Gedeon Richter<br />

4881. Segan Selegilinum tab. 5mg N60 Polpharma<br />

4882. Selegiline Alpharma Tablets<br />

5mg<br />

4883. Selenin's guttae — Guttae<br />

Zelenini<br />

Selegilinum tablets 5mg N30 Alpharma Limited<br />

Tinct.Belladonnae+<br />

Tinct.Convallariae+ Tinct.<br />

Valerianae+ Mentholum<br />

oral drops, sol. 0,2ml+ 0,4ml+ 0,4ml+<br />

8mg/ml 25ml<br />

Riga Pharmaceutical<br />

Plant<br />

4884. Semprex Acrivastinum caps. 8mg N24 Wellcome<br />

4885. Senadex Extract of leaves of senna tablets 0,07g N30;N50; N100;N120 SC ‘Concern Stirol’<br />

4886. Senelaks AC Sennae dry extract<br />

(assay of hydroxyanthracenic<br />

derivatives as sennoside B NLT<br />

20 %)<br />

4887. Seniovita aktiv Allium sativum Ø +Crataegus<br />

Ø + Sabal serrulatum Ø +<br />

Pulsatilla D4+ Phosphorus D4<br />

caps. 50 (10 mg)<br />

N15, N 30<br />

tab. 20mg+ 20mg+ 20mg+ 20mg+<br />

20mg N40;N100<br />

Hasco-Lek/ Acorus<br />

calamus<br />

4888. Senna fix Sennae folium herbal tea 1g/sachets N20 Herba Humana<br />

4889. Senos lapai Fol. Sennae herbal tea 50g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

4890. Septanest with Adrenaline<br />

1/200 000<br />

4891. Septanest with adrenaline<br />

1/100 000<br />

Articainum+<br />

Epinephrinum<br />

4892. Septolete Benzalkonii chloridum+<br />

Mentholum+ Menthae<br />

piperitae aetheroleum+<br />

Eucalypti aetheroleum +<br />

Thymolum<br />

4893. Septolete D Benzalkonii chloridum+<br />

Mentholum+ Menthae<br />

piperitae aetheroleum+<br />

Eucalypti aethoroleum+<br />

Thymolum<br />

4894. Septolete Plus Cetylpyridinii chloridum+<br />

Benzocainum<br />

sol. for inj. 68mg+8,5µg/ carpules (1,7ml)<br />

N50<br />

Articainum+Epinephrinum sol. for inj. 68mg+17µg/ carpules (1,7ml)<br />

N50<br />

lozenges 1mg+1,2mg+1mg+0,6mg+<br />

0,6mg<br />

N30<br />

lozenges (sugarfree)<br />

lozenges 1mg+5mg<br />

N30<br />

1mg+1,2mg+1mg+0,6mg+<br />

0,6mg<br />

N30<br />

Redel<br />

Septodont<br />

Septodont<br />

KRKA<br />

KRKA<br />

KRKA


EN<br />

338 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4895. Serdolect Sertindolum tab. 16mg<br />

N28; N100<br />

4896. Serdolect Sertindolum tab. 4mg N28;<br />

N30; N100<br />

4897. Serdolect Sertindolum tab. 20mg<br />

N28; N100<br />

4898. Serdolect Sertindolum tab. 12mg<br />

N28; N100<br />

4899. Seretide 100 Discus Salmeterolum +Fluticasonum inhalalation<br />

powder<br />

4900. Seretide 250 Discus Salmeterolum+ Fluticasonum inhalalation<br />

powder<br />

4901. Seretide 500 Discus Salmeterolum+ Fluticasonum inhalalation<br />

powder<br />

4902. Seretide Inhaler 125 Salmeterolum+<br />

Fluticasoni propionas<br />

4903. Seretide Inhaler 250 Salmeterolum+<br />

Fluticasoni propionas<br />

4904. Seretide Inhaler 50 Salmeterolum+<br />

Fluticasoni propionas<br />

inhalation<br />

aerosol<br />

inhalation<br />

aerosol<br />

inhalation<br />

aerosol<br />

4905. Serevent Salmeterolum aerosol for<br />

inhal.<br />

Strength Manufacturer<br />

50µg+100µg/dose 28 and 60<br />

doses<br />

50µg+250µg/dose 28 and 60<br />

doses<br />

50µg+500µg/dose 28 and 60<br />

doses<br />

Lundbeck<br />

Lundbeck<br />

Lundbeck<br />

Lundbeck<br />

Glaxo<br />

Glaxo<br />

Glaxo<br />

25µg+125µg/dose 120 doses Glaxo Wellcome<br />

25µg+250µg/dose 120 doses Glaxo Wellcome<br />

25µg+50µg/dose 120doses Glaxo Wellcome<br />

25µg/dose 60 and 200 doses Glaxo Wellcome<br />

4906. Serevent Diskus Salmeteroli xinafoas inhal powder 50µg/dose 60 doses Glaxo<br />

4907. Sermion Nicergolinum coated tab. 5mg N30 Pharmacia & Upjohn<br />

4908. Sermion Nicergolinum coated tab. 10mg N50 Pharmacia & Upjohn<br />

4909. Sermion Nicergolinum powder for sol.<br />

for inj.<br />

4mg N4 Pharmacia & Upjohn<br />

4910. Sermion Nicergolinum coated tab. 30mg N30 Pharmacia & Upjohn<br />

4911. Serocryptin Bromocriptinum tab. 2,5mg<br />

N30<br />

Serono<br />

4912. Seromycin Cycloserinum caps. 250mg N40 Eli Lilly<br />

4913. Serophene Clomifenum tab. 50mg<br />

N10; N30<br />

4914. Seroquel Quetiapine tab. 25mg N60 AstraZeneca<br />

4915. Seroquel Quetiapine tab. 100mg N30; N60; N90 AstraZeneca<br />

4916. Seroquel Quetiapine tab. 200mg N30; N60; N90 AstraZeneca<br />

4917. Seroxat Paroxetinum film-coated tab. 20mg<br />

N30<br />

4918. Seroxat Paroxetinum film-coated tab. 30mg<br />

N30<br />

Serono<br />

SmithKline Beecham<br />

SmithKline Beecham<br />

4919. Serzone 100 mg Nefazodonum tab. 100mg N28; N56 Bristol-Myers Squibb<br />

4920. Serzone 200 mg Nefazodonum tab. 200mg N28; N56 Bristol-Myers Squibb


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 339<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4921. Sevorane Sevofluranum volatile liquid 100 % (V/V) 100ml; 250ml Abbott<br />

4922. Sidabrazˇoliu˛ tinktūra Tormentillae radix trinct. 200 g Ethanolum ad 1 l 50 ml;<br />

100 ml<br />

Bakteriniai<br />

preparatai<br />

4923. Sieros 33,3 % tepalas Sulfur praecipitatum ointment 33,3g/100g 25g; 40g; 100g Sanitas<br />

4924. Sifloks Ciprofloxacinum tab. 500mg N14 Eczacibasi<br />

4925. Signopam Temazepamum tab. 10mg<br />

N20<br />

Polfa Tarchomin<br />

4926. Silver proteinate (Protargol) Argenti proteinas subst. Ag 7,5-8,5% 5kg; 10kg; 25kg Laboratorios Argenol<br />

4927. Simgal 10 mg Simvastatinum coated tab. 10mg N28 IVAX-CR<br />

4928. Simgal 20 mg Simvastatinum coated tab. 20mg N28 IVAX-CR<br />

4929. Simgal 40 mg Simvastatinum coated tab. 40mg N28 IVAX-CR<br />

4930. Simicol Dimeticonum drops 40mg/0,6ml 30ml CTS<br />

4931. Simulect Basiliximab powder and<br />

solvent for sol.<br />

for inj.<br />

4932. Simvacor 10 Simvastatinum film-coated tab. 10mg<br />

N30<br />

4933. Simvacor 20 Simvastatinum film-coated tab 20mg<br />

N30<br />

4934. Simvastatin-ratiopharm 10 Simvastatinum film-coated<br />

tablets<br />

4935. Simvastatin-ratiopharm 20 Simvastatinum film-coated<br />

tablets<br />

4936. Simvastatin-ratiopharm 40 Simvastatinum film-coated<br />

tablets<br />

4937. Simvor 10 Simvastatinum film-coated tab. 10mg<br />

N50<br />

4938. Simvor 20 Simvastatinum film-coated tab. 20mg<br />

N50<br />

4939. Simvor 40 Simvastatinum film-coated tab. 40mg<br />

N50<br />

4940. Simvor 5 Simvastatinum film-coated tab. 5mg<br />

N50<br />

20mg/vial+ 5ml amp. water<br />

for inj. N1<br />

Novartis Pharma/<br />

Novartis Pharma<br />

Stein<br />

GEA<br />

GEA<br />

10mg N28;N30 Merckle<br />

20mg N28;N30 Merckle<br />

40mg N28;N30 Merckle<br />

4941. Sinaflanum Flucinoloni acetonidum ung. 0,025% 15g Liuks<br />

4942. Sinemet Levodopum+ Carbidopum tab. 250mg+ 25mg N30; N100 MSD<br />

4943. Sinemet 25/100 mg Carbidopum+Levodopum tab. 25mg+<br />

100mg N30<br />

4944. Sinemet CR Levodopum+ Carbidopum tab. 200mg+ 50mg N100; N30 MSD<br />

Ranbaxy<br />

Ranbaxy<br />

Ranbaxy<br />

Ranbaxy<br />

4945. Sinex Oxymetazolinum nasal spray 0,5mg/ml 15ml Procter & Gamble<br />

4946. Singulair Montelukastum natricum chewable tab. 5mg N28 MSD<br />

4947. Singulair Montelukastum natricum film-coated tab. 10mg N28 MSD<br />

MSD


EN<br />

340 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

4948. Singulair Montelukastum natricum chewable tab. 4mg<br />

N28<br />

Strength Manufacturer<br />

4949. Singulair Mini Montelukastum oral granules 4mg N7;N28 Merck Sharp &<br />

Dohme<br />

4950. Sinopryl Lisinoprilum tab. 20mg N20 Eczacibasi<br />

4951. Sintomicino linimentas 10 % Synthomycinum lin. 100mg/g<br />

25g<br />

4952. Sintomicino linimentas<br />

5%<br />

Synthomycinum lin. 50mg/g<br />

25g<br />

4953. Sinupret Rad.Gentianae+ Flor.Primulae+<br />

Herb.Rumicis+ Flor.Sambuci+<br />

Herb.Verbenae<br />

4954. Sinupret Rad.Gentianae+ Flor.Primulae+<br />

Herb.Rumicis+ Flor.Sambuci+<br />

Herb.Verbenae<br />

(Ethanolum 19%)<br />

drag. 6mg+ 18mg+ 18mg+ 18mg+<br />

18mg N50<br />

drops 0,2g+0,6g+ 0,6g+0,6g+<br />

0,6g/100g 100ml; 200ml;<br />

500ml<br />

4955. Sirdalud Tizanidinum tab. 2mg<br />

N30<br />

4956. Sirdalud Tizanidinum tab. 4mg<br />

N30<br />

4957. Širdies darba˛ gerinantys lašai Tinct.Valerianae+<br />

Tinct.Crataegi+ Tinct.Leonuri<br />

4958. Širdies darba˛ gerinantys lašai Tinct. Valerianae+ Tinct.<br />

Crataegi+ Tinct.Leonuri<br />

4959. Širdies lašai Tinct.Leonuri+Tinct.<br />

Valerianae+ Tinct. Crataegi fl.<br />

4960. Širdies lašai BP Tinct.Valerianae+<br />

Tinct.Leonuri+Extr. Crataegi<br />

fluidum<br />

4961. Širdies veikla˛ reguliuojantis<br />

vaistazˇoliu˛ mišinys<br />

Herb.Equiseti+ Herb. Polygoni<br />

avicularis+ Flor.cum<br />

fol.Crataegi<br />

4962. Sirupas nuo kosulio Extr. Thymi<br />

Extr. Melissae<br />

Extr. Echinaceae<br />

MSD<br />

Bakteriniai<br />

preparatai<br />

Bakteriniai<br />

preparatai<br />

Bionorica<br />

Bionorica<br />

Novartis Pharma<br />

Novartis Pharma<br />

drops 34ml+33ml+33ml 30ml Bakteriniai<br />

preparatai<br />

drops 34ml+33ml+ 33ml<br />

30ml<br />

drops 34ml+33ml+ 34ml<br />

(Ethanolum >=61,5%) 40ml<br />

drops 34ml+33ml+<br />

33ml (Ethanolum 61,5- 70 %)<br />

30ml; 40ml; 50ml<br />

Sanitas<br />

Vilniaus f.f.<br />

Bakteriniai<br />

preparatai<br />

tea 20g+30g+50g Švenčioniu˛<br />

vaistazˇole˙s<br />

syr. 30+ 10+10 Bakteriniai<br />

preparatai<br />

4963. Sirupus Plantaginis Extr. Plantaginis syrup 13,2g/125g 125g Hasco-Lek<br />

4964. Ske˙tine˙s širdazˇole˙s zˇole˙ Herb. Centaurii tea Acorus Calamus<br />

4965. Skinoren Acidum azelaicum cream 200mg/g<br />

30g<br />

Schering<br />

4966. Skinosan B5 Dexpanthenolum ointment 5% — 25g Sanitas<br />

4967. Skruzdzˇiu˛ rūgšties spiritas Acidum formicicum topical sol. 12,5mg (Ethanolum 70 % ad<br />

1ml) 30ml; 50ml<br />

4968. Skruzdzˇiu˛ spiritas Acidum formicicum+<br />

Ethanolum 70%<br />

4969. Skruzdzˇiu˛ spiritas Acidum formicicum+<br />

Ethanolum 70%<br />

Sanitas<br />

sol. 14g+ 986g/1000g Bakteriniai<br />

preparatai<br />

sol. 14g+986ml 40ml Vilniaus f.f.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 341<br />

No. Commercial name General name<br />

4970. Skruzdzˇiu˛ spiritas Acidum formicicum+<br />

Ethanolum 70%<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

sol. 1,4g+ 98,6g 50ml Bakteriniai<br />

preparatai<br />

laboratorija Galen<br />

4971. Skystas gudobele˙s ekstraktas Crataegi fructus liq. extr. 1 000g (Ethanolum 70% ad 1l)<br />

25ml<br />

4972. Skystas gudobele˙s ekstraktas Fructus Crataegi subtilissimus<br />

+ Ethanolum 70%<br />

Vilniaus f.f.<br />

sol. 1000g +ad 1l 25ml Bakteriniai<br />

preparatai<br />

4973. Skystas gudobele˙s ekstraktas Fructus Crataegi Extr. 1 000g (Ethanolum 70 % ad<br />

1l) 25ml; 19kg<br />

4974. Skystas medicininis deguonis Oxygenium Kriogenas<br />

4975. Skystis ranku˛ odai minkštinti Glycerolum+ Sol.Ammonii<br />

caustici 10%+ Ethanolum 95%<br />

4976. Skystis ranku˛ odai minkštinti Glycerolum+Solutio Ammonii<br />

caustici 10%+ Ethanolum 96%<br />

4977. Skystis ranku˛ odai minkštinti Glycerolum+Ammoniae<br />

solutio 10%+Ethanolum 95%<br />

4978. Šlapima˛ varantis vaistazˇoliu˛<br />

mišinys<br />

4979. Šlapimo išsiskyrima˛ skatinantis<br />

vaistazˇoliu˛ mišinys<br />

Uvae ursi folium+Liquiritae<br />

radix+Juniperi pseudofructus<br />

Juniperi fruct.+<br />

Uvae ursi fol.+<br />

Betulae fol.<br />

4980. Slovalgin 100 retard Morphini sulfas pentahydricus slow-release<br />

film-coated tab.<br />

Sanitas<br />

sol. 25g+25g+25ml/100ml 80ml Vilniaus f.f.<br />

liq. 25g+25ml+ad 25ml/100ml<br />

40ml; 80ml<br />

liq. 0,25ml+<br />

0,25ml+<br />

0,25ml/ml 50ml;100ml<br />

herbal tea 40g+20g+<br />

40g/100g 50g; 37,5g<br />

(1,5g×25)<br />

herbal tea 40g+30g+<br />

30g<br />

50g; 50g (2g× 25);<br />

44g (2g×22)<br />

4981. Slovalgin 30 retard Morphini sulfas coated tab. 30mg<br />

N10; N20<br />

4982. Slovalgin 60 retard Morphini sulfas pentahydricus slow-release<br />

film-coated tab.<br />

4983. Slow-Mag B6 Magnesii chloridum+<br />

Pyridoxinum<br />

gastro-resistant<br />

tablets<br />

4984. Smecta Diosmectite powder for oral<br />

susp.<br />

Sanitas<br />

Bakteriniai<br />

preparatai<br />

Acorus Calamus<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

100mg N30;N60 Slovakofarma<br />

Slovakofarma<br />

60mg N30;N60 Slovakofarma<br />

535mg+5mg N50 Curtis Health care<br />

Ltd/Sanitas<br />

3g/sachet<br />

N10; N30<br />

Beaufour Ipsen<br />

Industrie<br />

4985. Smiltyninio šlamučio zˇiedynai Flor. Helichrysi arenarii herbal tea 50g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

4986. Smiltyniniu˛ šlamučiu˛ zˇiedynai<br />

(smulkinti)<br />

Flor. Helichrysi arenarii herbal tea 25g;50g Švenčioniu˛<br />

vaistazˇole˙s<br />

4987. Smulkinta čiobreliu˛ zˇole˙ Herb.Serpylii herbal tea 50g(2g×25);100g;<br />

16,8g(0,7g×24); 24g(1g×24);<br />

36g(1,5g×24); 48g(2g×24).<br />

4988. Smulkinta jonazˇoliu˛ zˇole˙ Herb. Hyperici herbal tea 50g; 100g; 50g (2g×25); 16,8g<br />

(0,7g×24); 24g (1g×24); 36g<br />

(1,5g×24); 48g (2g×24)<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

4989. Smulkinta melisu˛ zˇole˙ Melissae herba herbal tea 100g;50g Karvelio terapijosfitoterapi-jos<br />

i˛mone˙<br />

4990. Smulkinta šaltekšnio zˇieve˙ Cort. Frangulae herbal tea 100g Švenčioniu˛<br />

vaistazˇole˙s


EN<br />

342 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

4991. Smulkinti berzˇu˛ lapai Betulae folium herbal tea 100g;50g Karvelio terapijosfitoterapi-jos<br />

i˛mone˙<br />

4992. Smulkinti brukne˙s lapai Fol. Vitis idaeae herbal tea 50g; 50g (2g×25); 100g Švenčioniu˛<br />

vaistazˇole˙s<br />

4993. Smulkinti gudobeliu˛ zˇiedai ir<br />

lapai<br />

Flor.et fol.Crataegi herbal tea 50g Švenčioniu˛<br />

vaistazˇole˙s<br />

4994. Smulkinti juodalksnio vaisiai Fruct. Alni glutinosae herbal tea 50g Švenčioniu˛<br />

vaistazˇole˙s<br />

4995. Smulkinti meškauoge˙s lapai Fol. Uvae ursi herbal tea 48g(2g×24);50g;100g;<br />

16,8g(0,7g× 24); 24g(1g×24);<br />

36g(1,5g×24)<br />

4996. Smulkinti senos lapai Fol. Sennae herbal tea 50g;16,8g (0,7g×24);<br />

24g(1g×24); 36g(1,5g×24);<br />

48g(2g×24).<br />

4997. Smulkinti valerijonu˛<br />

šakniastiebiai su šaknimis<br />

4998. Smulkintos saldymedzˇiu˛<br />

šaknys<br />

4999. Snow White Petroleum Jelly<br />

DAB/BP/USP<br />

Rhiz. cum rad. Valerianae herbal tea 48g(2g×24) 50g;100g;<br />

16,8g(0,7g×24); 24g(1g×24);<br />

36g(1,5g×24).<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Rad.Glycyrrhizae subst. 25kg Švenčioniu˛<br />

vaistazˇole˙s<br />

Vaselinum subst. 175kg net/<br />

192kg gross; drums<br />

Schumann Sasol<br />

5000. Sodium Acetate trihydrate Natrii acetas trihydricum subst. 50kg Kirsch Pharma<br />

5001. Sodium Benzoate Natrii benzoas subst. 25kg Kirsch Pharma<br />

5002. Sodium Bicarbonate Natrii hydrocarbonas subst. 25kg Kirsch Pharma<br />

5003. Sodium Bicarbonate 4,2 %<br />

Braun<br />

5004. Sodium Bicarbonate 8,4 %<br />

Braun<br />

Natrii hydrogenocarbonas sol.for inf. 4,2g/100ml 250ml Braun Melsungen<br />

Natrii hydrocarbonas sol. for inf. 8,4g/100ml 100ml; 250ml Braun Melsungen<br />

5005. Sodium Bromide Natrii bromidum subst. 50kg Kirsch Pharma<br />

5006. Sodium Chloride Natrii chloridum subst. 50kg Kirsch Pharma<br />

5007. Sodium Chloride 0,9 % Braun Natrii chloridum sol. for inf. 9g/1000ml 100ml; 250ml;<br />

500ml; 1000ml<br />

5008. Sodium Chloride 0,9 % Braun Natrii chloridum sol. for inj. 0,9g/100ml 10ml, 20ml polyethylene<br />

amp. N20<br />

5009. Sodium Chloride 0,9 % Braun Natrii chloridum sol. for inj. 0,9g/100ml 50ml, 100ml glass<br />

vials N20<br />

5010. Sodium chloride 0,9 %<br />

Irrigation<br />

Natrii chloridum irrigation sol. 9mg/ml 500ml; 3000ml Ilsanta<br />

Braun Melsungen<br />

Braun Melsungen<br />

Braun Melsungen<br />

5011. Sodium chloride 0,9 % Natrii chloridum irrigation sol. 9mg/ml 1000ml Unimedic<br />

5012. Sodium Chloride 5,85 % Braun Natrii chloridum concentrate for<br />

sol. for inf.<br />

5,85g/100ml 20ml;100ml Braun Melsungen<br />

5013. Sodium Chloride 0,9 % Natrii chloridum sol. for inf. 9g/1 000ml 100ml; 250ml;<br />

500ml;<br />

1 000ml<br />

Human<br />

5014. Sodium chloride 10 % Natrii chloridum irrigation sol. 100mg/ml 1000ml Unimedic


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 343<br />

No. Commercial name General name<br />

5015. Sodium chloride 10 % 100ml<br />

conc. solution for infusion<br />

5016. Sodium Iodide<br />

[ 131 I] Injection<br />

Pharmaceutical<br />

form<br />

Natrii chloridum conc. for sol.<br />

for inf.<br />

Strength Manufacturer<br />

100mg/ml 100ml Ilsanta<br />

Sodium iodide [ 131 I] sol. for inj. 74 MBq/ml 37 MBq;<br />

74 MBq; 185 MBq;<br />

370 MBq; 555 MBq;<br />

740 MBq<br />

5017. Sodium Iodide [ 131 I] Injection Sodium iodide [ 131 I] sol. for inj. 925 MBq/ml 925MBq;<br />

1,11GBq; 1,48GBq; 1,85GBq;<br />

2,96GBq; 3,79GBq; 5,55GBq;<br />

7,4GBq; 9,25GBq<br />

5018. Sodium iodide- 131 I Sodium iodide- 131 I gelat. caps. 1-2000 MBq Polatom<br />

5019. Sodium iodide- 131 I Sodium iodide- 131 I sol. for inj. 37-370 MBq/ml 10ml Polatom<br />

5020. Sogoon Extr. Harpagophytum<br />

procumbens (Glaudene˙s sausas<br />

ekstraktas)<br />

5021. Sol. Glucosi cum Natrii<br />

chloridi et Kalii chloridi pro<br />

infusionibus<br />

5022. Sol. Glucosi cum Natrii<br />

chloridi pro infusionibus<br />

5023. Sol. Natrii thiosulfatis<br />

30 % pro injectionibus<br />

Natrii chloridum+ Kalii<br />

chloridum+ Glucosum<br />

film-coated tab. N20; N50; N100 Liuks<br />

sol. for inf. 3g+ 1,5g+ 34g/<br />

1000ml 250ml;<br />

500ml;<br />

1000ml plastic bag; 250ml;<br />

500ml ‘Propyflex’.<br />

Natrii chloridum+ Glucosum sol. for inf. 3g+34g/1000ml 250ml;<br />

500ml; 1000ml plastic bag;<br />

250ml;500ml Propyflex bag<br />

Natrii thiosulfas sol. for inj. 3g/10ml<br />

10ml<br />

5024. Sol. Phentanyli 0,005 % Fentanylum sol. for inj. 0,1mg/2ml<br />

N10<br />

5025. Sol. Proserini 0,05 % Neostigmini methylsulfas sol. for inj. 0,5mg/ml<br />

N10<br />

5026. Solcoderm Acidum nitricum 70%+<br />

Acidum aceticum 99%+<br />

Acidum oxalicum dihydricum+<br />

Acidum lacticum 90%+Cupri<br />

(II) nitras<br />

5027. Solcogyn Acidum nitricum 65%+<br />

Acidum aceticum 98%+<br />

Acidum oxalicum dihydricum+<br />

Zinci (II) nitras<br />

sol.for external<br />

application<br />

sol.for topical<br />

use<br />

5028. SolcoTrichovac Lactobacillus acidophilus powder and<br />

solvent for<br />

sol.for inj.<br />

116,132mg+8,216mg+<br />

11,47mg+ 0,968mg+<br />

9,6µg/0,2ml N1;N5<br />

578,4mg+ 20,4mg+ 58,6mg+<br />

6mg/ml N2<br />

>7×10(9)/ vial+0,5ml water for<br />

inj. N1;N3<br />

Nycomed Amersham<br />

Nycomed Amersham<br />

Grindex<br />

Grindex<br />

Kalceks<br />

Kalceks<br />

Kalceks<br />

Solco Basel<br />

Solco Basel<br />

Solco Basel<br />

5029. Solian Amisulpridum tab. 50mg N30 Synthelabo<br />

5030. Solian Amisulpridum tab. 200mg N30 Synthelabo<br />

5031. Solian Amisulpridum sol. for inj. 200mg/4ml N6 Synthelabo<br />

5032. Solian 100 mg Amisulpridum scored tab. 100mg N30 Synthelabo<br />

5033. Solian 400 mg Amisulpridum scored filmcoated<br />

tab.<br />

5034. Solpadeine Paracetamolum+ Codeinum+<br />

Coffeinum<br />

400mg<br />

N30<br />

tab. 500mg+8mg+<br />

30mg<br />

N24; N12<br />

Synthelabo<br />

SmithKline Beecham


EN<br />

344 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

5035. Solpadeine Soluble Tablets Paracetamolum+ Codeini<br />

phosphas+ Coffeinum<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

tab. 500mg+ 8mg+30mg N12 SmithKline Beecham<br />

5036. Solpaflex Ibuprofenum caps. 300mg N12; N24; N36; N48 SmithKline & French<br />

5037. Solpaflex Ibuprofenum tab. 200mg N12; N24; N48; N50;<br />

N75; N100<br />

SmithKline Beecham<br />

5038. Solpaflex Gel Ibuprofenum gel 5g/100g 4g; 30g; 50g; 100g Fleet Laboratories<br />

5039. Solu-Cortef Hydrocortisonum (solvent:<br />

Benzyl alcohol 18mg/2ml)<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

5040. Solu-Medrol Methylprednisolonum powder and<br />

solvent for sol.<br />

for inj.<br />

5041. Solu-Medrol Methylprednisolonum powder and<br />

solvent for sol.<br />

for inj.<br />

5042. Solu-Medrol Methylprednisolonum powder and<br />

solvent for sol.<br />

for inj.<br />

5043. Solu-Medrol Methylprednisolonum powder and<br />

solvent for sol.<br />

for inj.<br />

5044. Solu-Medrol Methylprednisolonum powder and<br />

solvent for sol.<br />

for inj.<br />

5045. Solutio Aminasini<br />

2,5 % pro injectionibus<br />

5046. Solutio Glucosi 40 % pro<br />

injectionibus<br />

5047. Solutio Magnesii sulfatis<br />

25 % pro injectionibus<br />

Chlorpromazinum sol. for inj. 50mg/2ml<br />

N10<br />

Glucosum sol. for inj. 400mg/ml<br />

10ml<br />

N10<br />

Magnesii sulfas sol. for inj. 2,5g/10ml<br />

N10<br />

100mg two-compartment vial<br />

N1;N25<br />

40mg/two-compartment vial +<br />

1ml diluent<br />

N1<br />

250mg/two-compartment<br />

vial+4ml diluent<br />

N1<br />

125mg/two-compartment<br />

vial+2ml diluent<br />

N1<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

500mg/vial +7,8ml diluent N1 Pharmacia & Upjohn<br />

1000mg/vial +15,6ml diluent<br />

N1<br />

Pharmacia & Upjohn<br />

Kalceks<br />

Kalceks<br />

Kalceks<br />

5048. Solutio Natrii oxybutyrati 20 % Natrii oxybutyras sol. for inj. 200mg/ml 10ml amp. N10 Kalceks<br />

5049. Somatogen-L 4 TV Hormonum incrementi<br />

humanum recombinatum<br />

5050. Somatogen-L 4 TV Hormonum incrementi<br />

humanum recombinatum<br />

5051. Somatogen-L 8 TV Hormonum incrementi<br />

humanum recombinatum<br />

5052. Somatogen-L 8 TV Hormonum incrementi<br />

humanum recombinatum<br />

5053. Somatuline PR Lanreotidum powder and<br />

solvent for<br />

susp. for<br />

inj.prolongedrelease<br />

formulation<br />

for inj.dried 4 UI/amp. N5 Biotechna<br />

for inj.dried 4 UI /vial N5 Biotechna<br />

for inj.dried 8 UI/vial N5 Biotechna<br />

for inj.dried 8 UI/amp. N5 Biotechna<br />

30mg/vial N1;N2 Pharma Biotech<br />

5054. Somnols 7,5 mg Zopiclonum film-coated tab. 7,5mg N10 Grindeks<br />

5055. Sonata Zaleplonum caps., hard 5mg N7;N10;N14 Wyeth<br />

Pharmaceuticals


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 345<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5056. Sonata Zaleplonum caps., hard 10mg N7;N10;N14 Wyeth<br />

Pharmaceuticals<br />

5057. Sopolcort H Hydrocortisonum sol. for inj. 100mg/5ml N5 Jelfa<br />

5058. Sorbisterit Calcium-charged cation<br />

exchanger<br />

5059. Sorbitol 3000ml Solution for<br />

Irrigation<br />

Sorbitolum+ Acidum aceticum<br />

glaciale<br />

powder 9,0014g/10g 500g Fresenius Medical<br />

Care Deutschland<br />

irrigation<br />

solution<br />

50g+ 2,5g/1000ml 3000ml Ilsanta<br />

5060. Sortis 10 mg Atorvastatinum film-coated tab. 10mg N30; N50; N100 Gödecke<br />

5061. Sortis 20 mg Atorvastatinum film-coated tab. 20mg N30; N50; N100 Gödecke<br />

5062. Sortis 40 mg Atorvastatinum film-coated tab. 40mg N28; N30; N50; N100 Gödecke<br />

5063. Sotalol 160-SL Sotalolum tab. 160mg N20;N100 Slovakofarma<br />

5064. Sotalol 80-SL Sotalolum tab. 80mg N20;N100 Slovakofarma<br />

5065. Sotastad Sotalolum tab. 160mg N20; N50; N100 Stada<br />

5066. Spartocine Ferri aspartas tab. 250mg N40; N100 UCB Pharma<br />

5067. Spartocine Ferri aspartas gran. for oral<br />

sol.<br />

5068. Spartocine Ferri aspartas gran. for oral<br />

sol.<br />

5069. Spascupreel Citrillus colocynthis D4+<br />

Ammonium bromatum D4+<br />

Atropinum sulfuricum D6+<br />

Veratrum album D6+<br />

Magnesium phosporicum D6 +<br />

Gelsemium sempervirens D6+<br />

Passiflora incarnata D2+<br />

Agaricus D4+<br />

Chamomilla recutita D3+<br />

Cuprum sulfuricum D6 +<br />

Aconitum napellus D6<br />

5070. Spascupreel S Citrillus colocynthis D3+<br />

Ammonium bromatum D3+<br />

Atropinum sulfuricum D5+<br />

Veratrum album D5+<br />

Magnesium phosphoricum D6+<br />

Gelsemium sempervirens D5+<br />

Passiflora incarnata D1+<br />

Chamomilla recutita D2+<br />

Cuprum sulfuricum D5+<br />

Agaricus D3+<br />

Aconitum napellus D5<br />

105mg/sachet N14; N30;<br />

N100<br />

tab. 30mg+30mg+<br />

30mg+30mg+<br />

30mg+30mg+<br />

15mg+15mg+<br />

15mg+15mg+<br />

60mg<br />

UCB Pharma<br />

350mg/sachet N30; N100 UCB Pharma<br />

supp. 1,1g+1,1g+<br />

1,1g+1,1g+<br />

1,1g+1,1g+ 0,55g+0,55g+<br />

0,55g+<br />

0,55g+2,2g N12; N60; N120<br />

5071. Spasmomen Otilonii bromidum film-coated tab. 40mg<br />

N30<br />

5072. Spasmosan Drotaverinum sol. for<br />

injections<br />

Heel<br />

Heel<br />

Menarini<br />

40 mg Sanitas<br />

5073. Spasmosan Drotaverinum tab. 40 mg Sanitas<br />

5074. Spasmosan Forte Drotaverinum sol. for<br />

injections<br />

80 mg Sanitas<br />

5075. Spasmosan Forte Drotaverinum tab. 80 mg Sanitas


EN<br />

346 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

5076. Spazmalgono tablete˙s Metamisolum+<br />

Pitofenoni hydrochloridum+<br />

Pheniverini bromidi<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

tab. N10; N20; N30 Liuks<br />

5077. Species nervinae Planta compos. species, tea bags 1,5g every tea bag, N20 Leros Co.Ltd<br />

5078. Spersallerg Antazolinum+<br />

Tetryzolinum<br />

5079. Spigelon Spigelia anthelmia D3+ Atropa<br />

belladonna D3+ Bryonia<br />

cretica D3+ Gelsemium<br />

sempervirens D3 +Melilotus<br />

officinalis D3+ Natrium<br />

carbonicum D3+Acidum<br />

silicicum D12+ Thuja<br />

occidenttalis D12<br />

5080. Spiriva Tiotropii bromidum inhal. powder<br />

in caps.<br />

eye drops 0,5mg+0,4mg/ml 10ml Ciba Vision<br />

tab. 30mg+30mg+30mg+ 30mg+<br />

30mg+30mg+ 60mg+60mg<br />

N50; N250<br />

18µg<br />

N30; N60;<br />

5081. Spirix Spironolactonum tab. 25mg<br />

N20<br />

5082. Spirix Spironolactonum tab. 100mg<br />

N20<br />

5083. Spirix Spironolactonum tab. 50mg<br />

N20<br />

5084. Spironolacton ratiopharm 50 Spironolactonum tab. 50mg<br />

N20<br />

5085. Spironolaktono 100 mg<br />

tablete˙s<br />

Heel<br />

Boehringer<br />

Ingelheim/<br />

Roxane Laboratories<br />

Nycomed DAK/SEFA<br />

Nycomed DAK/SEFA<br />

Nycomed DAK/SEFA<br />

Merckle<br />

Spironolactonum tab. 100 mg N20, N30, N50 Liuks<br />

5086. Spironolaktono 25 mg tablete˙s Spironolactonum tab. 25 mg N20, N30, N50 Liuks<br />

5087. Spironolaktono 50 mg tablete˙s Spironolactonum tab. 50 mg N20, N30, N50 Liuks<br />

5088. Spitomin Buspironi hydrochloridum tab. 10mg<br />

N60<br />

5089. Spitomin 5 mg Buspironi hydrochloridum tab. 5mg<br />

N60<br />

5090. Sporanox Itraconazolum oral sol. 10mg/ml 150ml Janssen<br />

5091. Sporidex 250 Cefalexinum caps. 250mg N30 Ranbaxy<br />

5092. Sporidex 500 Cefalexinum caps. 500mg N10 Ranbaxy<br />

5093. Spray-Pax Piperonyl butoxide+<br />

Pyrethrum extract 25%<br />

5094. Spregal Esdepallethrin+<br />

Piperonyl butoxide<br />

+Ethylic alcohol 95%<br />

5095. Stabisol Hydroxyethylamylum solution for<br />

infusion<br />

Egis<br />

Egis<br />

lotion 2,667g+1,333g/100g 12g S.C.A.T.<br />

spray, sol. 0,63g+5,04g+<br />

6,433g/100g 160g; 80g<br />

Wolff<br />

60g/l 250ml; 500ml Berlin-Chemie<br />

5096. Stadaglicin Augentropfen Natrii cromoglicas eye drops,sol. 20mg/ml 10ml Vetter Pharma<br />

5097. Stadaglicin Nasenspray Natrii cromoglicas nasal spray, sol. 20mg/ml 15ml Vetter Pharma


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 347<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5098. Stadalax Bisacodylum drag. 5mg<br />

N50; N100<br />

5099. Staloral (sublingual solution of<br />

allergen extracts for specific<br />

immunotherapy)<br />

Allergen extracts for specific<br />

immunotherapy<br />

5100. Stamaril Pasteur (single dose) Lyophilized suspension of the<br />

Yellow fever virus,attenuated,<br />

stabilized,strain 17D,free from<br />

avian leucosis virus,cultivated<br />

in SPF chicken embryos<br />

sublingual sol. 0,1IR/ml; 1IR/ml;<br />

10 IR/ml;<br />

100 IR/ml; 300 IR/ml;<br />

0,1IC/ml; 1IC/ml;<br />

10 IC/ml;<br />

100 IC/ml 10ml<br />

powder and<br />

solvent for<br />

susp. for inj.<br />

5101. Standacillin 1 g vial Ampicillinum powder for sol.<br />

for inj.<br />

5102. Standacillin 0,5 g vial Ampicillinum powder for sol.<br />

for inj.<br />

Strength Manufacturer<br />

1000 LD(50)/amp+ 0,5ml<br />

syringe of diluent N1<br />

Stada<br />

Stallergenes<br />

Pasteur Merieux<br />

1g/vial N100 Biochemie<br />

500mg/vial N100 Biochemie<br />

5103. Standacillin 250 mg Ampicillinum caps., hard 250mg N1000 Biochemie<br />

5104. Standacillin 500 mg Ampicillinum caps., hard 500mg N12 Biochemie<br />

5105. Starkungs Tonikum mit<br />

Ginseng N<br />

Extr.rad.Ginsengi siccum 3,6:1 oral sol. 6,834mg/ml 500ml;1000ml Herzpunkt Pharma<br />

5106. Starlix Nateglidinum film-coated tab. 120mg<br />

N24<br />

5107. Starlix 60 mg Nateglinidum film-coated tab. 60mg<br />

N24<br />

5108. stas Halsschmerz-Tabletten Cetylpyridinii chloridum+<br />

Dequalinii chloridum<br />

tab. (sugar-free) 0,3mg+ 0,15mg N20 Stada<br />

Novartis Pharma<br />

Novartis Pharma<br />

5109. Staveran Verapamilum coated tab. 40mg N20 Polpharma<br />

5110. Staveran Verapamilum coated tab. 80mg N20 Polpharma<br />

5111. Staveran retard Verapamilum coated tab. 240mg N20 Polpharma<br />

5112. Staveran retard Verapamilum coated tab. 120mg N20 Polpharma<br />

5113. Stazepin Carbamazepinum tab. 200mg N50 Polpharma<br />

5114. Sterils salu škidums skalošanai Natrii chloridum+<br />

Kalii chloridum+<br />

Calcii chloridum+<br />

Magnesii chloridum<br />

+Natrii acetas<br />

5115. Sterilus vanduo injekcijoms Aqua ad iniectabilia sterile water for<br />

inj.<br />

sol. 1,6g+0,19g+<br />

0,16g+0,16g+<br />

1,62g/250ml 250ml; 500ml;<br />

1000ml<br />

100ml; 250ml; 500ml;<br />

1000ml<br />

5116. Stesolid Diazepamum rectal tube, sol. 10mg/2,5ml<br />

N5<br />

5117. Stesolid Diazepamum enema, rectal<br />

solution<br />

5118. Stilamin 250 Somatostatinum powder and<br />

solvent for sol.<br />

for inj. i.v.<br />

5119. Stilamin 3000 Somatostatinum powder for sol.<br />

for inf.<br />

5mg/2,5ml<br />

N5<br />

Grindex<br />

Ilsanta<br />

Dumex<br />

Dumex<br />

250µg N1; N5 Serono<br />

3mg/amp. N1 Serono


EN<br />

348 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5120. Stilnox Zolpidemi tartras scored filmcoated<br />

tab.<br />

Strength Manufacturer<br />

10mg N10;N20 Synthelabo<br />

5121. Stimol Citrulline malate (50%) oral sol. 2g/10ml amp.N18 Biocodex<br />

5122. Stimuloton 50 mg Sertralinum film-coated tab. 50mg<br />

N30<br />

5123. Stocrin Efavirenz caps., hard 50mg<br />

N30<br />

5124. Stocrin Efavirenz caps., hard 100mg<br />

N30<br />

5125. Stocrin Efavirenz caps., hard 200mg<br />

N90<br />

5126. Stodal Anemone pulsatilla 6CH+<br />

Rumex crispus 6CH+<br />

Bryonia dioica 3CH+<br />

Ipecacuanha 3CH+ Spongia<br />

tosta 3CH+Sticta pulmonaria<br />

3CH+<br />

Antimonium tartaricum 6CH+<br />

Myocardium 6CH+ Coccus<br />

cacti 3CH+ Drosera MT<br />

5127. Stoptussin Butamirati dihydrogenocitras+<br />

Guaifenesinum<br />

5128. Stoptussin Guaifenesinum+ Butamirati<br />

dihydrogencitras<br />

5129. Stoptussin Fyto Thymi extractum fluidum+<br />

Serpylli extractum fluidum+<br />

Plantaginis extractum fluidum<br />

5130. Strepsils Amylmetacresolum+Alcohol<br />

2,4-dichlorbenzylicus<br />

5131. Strepsils Honey and Lemon Amylmetacresolum+Alcohol<br />

2,4-dichlorbenzylicus<br />

5132. Strepsils Mentol and<br />

Eucalyptus<br />

Amylmetacresolum+Alcohol<br />

2,4-dichlorbenzylicus+<br />

Levomentolum<br />

5133. Strepsils with vit. C 100 mg Amylmetacresolum+Alcohol<br />

2,4-dichlorbenzylicus+ Acidum<br />

ascorbicum<br />

syrup 0,95g+0,95g+ 0,95g+0,95g+<br />

0,95g+0,95g+ 0,95g+0,95g+<br />

0,95g+0,95g/ 100g 200ml<br />

oral drops, sol. 40mg+ 1g/10ml (Ethanolum<br />

95% 3g/10ml)<br />

Egis<br />

MSD<br />

MSD<br />

MSD<br />

Boiron<br />

IVAX-CR<br />

tab. 100mg+ 4mg N20 IVAX-CR<br />

syrup 4,1666g+ 4,1666g+ 4,1666g/<br />

100ml 100ml<br />

IVAX-CR<br />

lozenges 0,6mg+1,2mg N24 Boots<br />

lozenges 0,6mg+1,2mg N24 Boots<br />

lozenges 0,6mg+1,2mg+8mg<br />

N24<br />

lozenges 0,6mg+1,2mg+100mg<br />

N24<br />

5134. Streptocido 10 % tepalas Sulfanilamidum ointment 10g/100g 25g; 40g Sanitas<br />

5135. Streptocido 5% tepalas Sulfanilamidum ointment 5g/100g<br />

25g; 40g<br />

5136. Streptokinase Braun<br />

1 500 000<br />

5137. Streptokinase Braun<br />

250 000<br />

5138. Streptokinase Braun<br />

750 000<br />

Streptokinasum powder for sol.<br />

for inj./inf.<br />

Streptokinasum powder for sol.<br />

for inj./inf.<br />

Streptokinasum powder for sol.<br />

for inj./inf.<br />

5139. Streptomycin Streptomycinum powder for<br />

solution for<br />

injection<br />

Boots<br />

Boots<br />

Sanitas<br />

1500000IU/ vial N1;N5 Braun Melsungen<br />

250000IU/vial N1; N5 Braun Melsungen<br />

750000IU/vial N1; N5 Braun Melsungen<br />

1g/vial N10 Balkanpharma-<br />

Razgrad AD


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 349<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5140. Streptomycini sulfas Streptomycinum powder for sol.<br />

for inj.<br />

5141. Streptomycini sulfas Streptomycinum powder for sol.<br />

for inj.<br />

5142. Streptomycini sulfas Streptomycinum powder for sol.<br />

for inj.<br />

Strength Manufacturer<br />

0,5g Kievmedpreparat<br />

1g Kievmedpreparat<br />

0,25g Kievmedpreparat<br />

5143. Streptomycini sulfas Streptomycinum pulv. pro inj. 0,25g N1; 0,5 g N1; 1,0g N1 Liuks<br />

5144. Strontium chloride-89SrCl2 Strontium chloride-89SrCl2 sol. for inj. 3,5-6,3 MBq/mg<br />

(150 MBq/4ml)<br />

5145. Structolipid 20% Triglyceridu saturata longa et<br />

media<br />

5146. Strumeel Spongia D3+<br />

Calcium jodatum D4+Acidum<br />

silicicum D4+Fucus vesiculosus<br />

D4<br />

5147. Strumeel forte NF Spongia D2+ Calcium jodatum<br />

D3+Fucus vesiculosus D3;<br />

(Ethanolum 40%)<br />

Polatom<br />

emuls. for inf. 200g/1000ml 250ml; 500ml Fresenius Kabi<br />

tab. 150mg+90mg+30mg+ 30mg Heel<br />

drops 50g+30g+ 10g/100g 30ml;<br />

100ml<br />

5148. Stugeron Cinnarizinum tab. 25mg<br />

N50<br />

Heel<br />

Gedeon Richter<br />

5149. Stugeron Cinnarizinum tab. 25mg N50 Janssen-Cilag<br />

5150. Stugeron forte Cinnarizinum caps., hard 75mg N20 Janssen<br />

Pharmaceutica<br />

5151. Subutex 0,4 mg Buprenorphinum sublingual<br />

tab.<br />

5152. Subutex 2 mg Buprenorphinum sublingual<br />

tab.<br />

5153. Subutex 8 mg Buprenorphinum sublingual<br />

tab.<br />

5154. Succinylcholinjodid inj. ICN Suxamethonii iodidum powder for sol.<br />

for inj.<br />

5155. Succinylcholinjodid inj. ICN Suxamethonii iodidum powder for sol.<br />

for inj.<br />

5156. Succus Echinaceae Herb.Echinaceae purpureae<br />

L.rac.+ Ethanolum 96%<br />

5157. Succus Plantaginis Plantaginis lanceolatae herbae<br />

succus<br />

0,4mg<br />

N7<br />

2mg<br />

N7<br />

8mg<br />

N7<br />

Reckitt Benckiser<br />

Healthcare (UK)<br />

Limited<br />

Reckitt Benckiser<br />

Healthcare (UK)<br />

Limited<br />

Reckitt Benckiser<br />

Healthcare (UK)<br />

Limited<br />

100mg/vial N1 ICN Czech Republic<br />

250mg/vial N1 ICN Czech Republic<br />

sol. 1pars+0,465partis 30g;100g Herbapol Kle˛ce<br />

oral liquid 100g Phytopharm Kle˛ka<br />

5158. Sucrace Sucralfatum tab. 1g N100 Cadila<br />

5159. Sucram Aspartam-Nutra Sweet powder 120 g Liuks<br />

5160. Sudafed Oxymetazolinum nasal spray, sol. 50mg/100ml 15ml Glaxo Wellcome<br />

5161. Sudafed Pseudoephedrini<br />

hydrochloridum<br />

5162. Sudafed Co Pseudoephedrinum+<br />

Paracetamolum<br />

tab. 60mg N12;N24 Cox<br />

tab. 60mg+ 500mg Glaxo Wellcome


EN<br />

350 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

5163. Sudafed expectorant Pseudoephedrinum+<br />

Guaifenesinum<br />

5164. Sudafed syrup Pseudoephedrini<br />

hydrochloridum<br />

5165. Sugar-free Fervex Paracetamolum+ Acidum<br />

ascorbicum +Pheniraminum<br />

5166. Sukatzˇole˙s tinktūra Herb. Leonuri subtilissimus +<br />

Ethanolum<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

syrup 30mg+100mg/5ml 100ml Glaxo Wellcome<br />

syrup 30mg/5ml 100ml Wellcome<br />

gran. for oral<br />

sol., sachets<br />

500mg+200mg+25mg<br />

N8 po 4,95g<br />

UPSA<br />

tinct. 200g +ad 1l 25ml Bakteriniai<br />

preparatai<br />

5167. Sukatzˇole˙s tinktūra Leonuri herba tinct. 200g (Ethanolum 70% ad 1l)<br />

25ml<br />

5168. Sukatzˇole˙s tinktūra Herb. Leonuri tinct. 200g (Ethanolum 70% ad<br />

praeparationibus 1 l tincturae<br />

Vilniaus f.f.<br />

5169. Sukatzˇole˙s zˇole˙ Herb. Leonuri herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

5170. Sukatzˇoliu˛ zˇole˙ (smulkinta) Herb. Leonuri herbal tea 50g;100g Švenčioniu˛<br />

vaistazˇole˙s<br />

5171. Sulfacilio natrio 20 % tirpalas Sulfacetamidum natricum eye drops sol. 200mg/ml 1,5ml<br />

N2; N4<br />

5172. Sulfacilio natrio 30 % tirpalas<br />

— akiu˛ lašai<br />

Sulfacetamidum natricum eye drops sol. 450mg/1,5ml ampule˙s-lašintuvai<br />

N2; N4<br />

5173. Sulfargin Sulfadiazinum ointment 10mg/g<br />

50g<br />

5174. Sulfasalazin Sulfasalazinum film-coated tab. 500mg<br />

N50<br />

5175. Sulfasalazino 500 mg tablete˙s Sulfasalazinum tab. 500mg<br />

N20<br />

5176. Sulfogajakol Sulfogaiacol tab. 500 mg N10 Liuks<br />

5177. Sulfogajakol Sulfogaiacol syr. 125 g Liuks<br />

5178. Sulfur-Heel Sulfur D4+Daphne- mezereum<br />

D4+ Arsenicum album D6+Pix<br />

liquida D6+ Caladium<br />

seguinum D4+ Capsicum<br />

annuum D4<br />

5179. Sulperazon Cefoperazonum+<br />

Sulbactamum<br />

tab. 30mg+15mg+ 15mg+ 60mg+<br />

90mg+90mg<br />

powder for<br />

solution for<br />

injection<br />

5180. Sulpiryd Sulpiridum tab. 200mg<br />

N12; N30<br />

Sanitas<br />

Endokrininiai<br />

preparatai<br />

Endokrininiai<br />

preparatai<br />

Tallinna<br />

Farmaatsiatehase<br />

KRKA<br />

Endokrininiai<br />

preparatai<br />

Heel<br />

1g+1g /vial N1 Pfizer Inc., Ilaclari<br />

A.S.<br />

Pliva Krakow<br />

5181. Sulpiryd 100 Sulpiridum caps. 100mg N24 Pliva Krakow<br />

5182. Sulpiryd 50 Sulpiridum caps. 50mg N24 Pliva Krakow<br />

5183. Sumamed Azithromycinum caps. 250mg<br />

N6<br />

5184. Sumamed Azithromycinum tab. 125mg<br />

N6<br />

5185. Sumamed Azithromycinum film-coated tab. 500mg<br />

N3<br />

Pliva<br />

Pliva<br />

Pliva


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 351<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5186. Sumamed Azithromycinum powder for oral<br />

susp.<br />

5187. Sumamed forte Azithromycinum powder for oral<br />

susp.<br />

5188. Sumamed injections Azithromycinum powder for sol.<br />

for inf.<br />

5189. Supero Cefuroximum powder for sol.<br />

for inj.<br />

Strength Manufacturer<br />

100mg/5ml 20ml Pliva<br />

200mg/5ml 20ml;30ml Pliva<br />

500mg/bottle N5 Pliva<br />

750mg/vial N1 Mitim<br />

5190. Supplin Metronidazolum film-coated tab. 250mg N20 Biochemie<br />

5191. Supplin Metronidazolum sol. for inf. 500mg/100ml 100ml Biochemie<br />

5192. Supplin Metronidazolum film-coated tab. 500mg N20 Biochemie<br />

5193. Supradyn (lemon flavor) Retinolum+ Thiaminum+<br />

Riboflavinum+ Pyridoxinum+<br />

Cyanocobalaminum+ Acidum<br />

ascorbicum+<br />

Ergocalciferolum+<br />

Tocoferolum+ Biotinum+<br />

Calcii pantothenas+ Acidum<br />

folicum+ Nicotinamidum+<br />

Calcium+ Magnesium+<br />

Ferrum+ Manganum+<br />

Phosphorus+ Cuprum+<br />

Zincum+<br />

Molybdenum<br />

5194. Suprastin Chloropyraminum chloratum tab. 25mg<br />

N20<br />

efferv. tab. 3333IU+ 20mg+5mg+ 10mg+<br />

5µg+150mg+ 200IU+ 10mg+<br />

0,25mg+ 11,6mg+ 1mg+<br />

50mg+ 51,3mg+ 5mg+<br />

1,25mg+ 0,5mg+ 47mg+<br />

0,1mg+ 0,5mg+ 0,1mg N10<br />

5195. Suprastin Chloropyraminum chloratum sol. for inj. 20mg/ml<br />

N5<br />

5196. Supraviran Aciclovirum cream 50mg/g 2g Grunenthal<br />

5197. Supraviran 200 Aciclovirum tab. 200mg<br />

N25<br />

5198. Supraviran 250 Aciclovirum powder for sol.<br />

for inf.<br />

250mg<br />

N1<br />

5199. Supraviran 400 Aciclovirum tab. 400mg<br />

N35<br />

5200. Supraviran 800 Aciclovirum tab. 800mg<br />

N35<br />

5201. Suprax Cefiximum coated tab. 200mg<br />

N10<br />

5202. Suprax Cefiximum powder for oral<br />

susp.<br />

Roche<br />

Egis<br />

Egis<br />

Grunenthal<br />

Grunenthal<br />

Grunenthal<br />

Grunenthal<br />

Gedeon Richter<br />

100mg/5ml 50ml Merck Farma y<br />

Quimica<br />

5203. Suprecur Buserelinum nasal spray, sol. 0,15mg/dose 10g Hoechst Marion<br />

Roussel<br />

5204. Sustac forte Glyceroli trinitras prolonged<br />

release tab.<br />

5205. Sustac mite Glyceroli trinitras prolonged<br />

release tab.<br />

6,4mg<br />

N25<br />

2,6mg<br />

N25<br />

KRKA<br />

KRKA


EN<br />

352 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

5206. Sustanon ‘250’ Testosteroni propionas+<br />

Testosteroni phenylpropionas+<br />

Testosteroni isohexanoas+<br />

Testosteroni decanoas<br />

Pharmaceutical<br />

form<br />

5207. Sustonit Glyceroli trinitras extended-release<br />

tab.<br />

5208. Sustonit 2,6 mg Glyceroli trinitras extended-release<br />

tab.<br />

5209. Sustonit 6,5 mg Glyceroli trinitras extended-release<br />

tab.<br />

5210. Švediška mikstūra Ex. Liquidum (ex. Aloe, Sennae<br />

folia, Rhei radix), Vinum<br />

meridianum<br />

sol. for inj. 30mg+60mg+<br />

60mg+100mg /ml N1<br />

15mg<br />

N30<br />

2,6mg<br />

N30<br />

6,5mg<br />

N30<br />

Strength Manufacturer<br />

Organon<br />

Polfa Warsaw<br />

Polfa Warsaw<br />

Polfa Warsaw<br />

etractum liq. 50 ml; 100 ml Bakteriniai<br />

preparatai<br />

5211. Svilarozˇiu˛ šaknys Rad. Althaeae subst. 30kg Švenčioniu˛<br />

vaistazˇole˙s<br />

5212. Svilarozˇiu˛ sirupas Maceratio ex radix Althaeae syrup 2g(34,9g)/ 100g Ethanolum<br />

95% 1g 125g<br />

5213. Symbicort Turbuhaler<br />

160/4,5µg/dose<br />

5214. Symbicort Turbuhaler<br />

80/4,5 µg/dose<br />

Budesonidum+<br />

Formoterolum<br />

Budesonidum+<br />

Formoterolum<br />

inhalation<br />

powder<br />

inhalation<br />

powder<br />

160µg+4,5 µg/dose 60 doses;<br />

120 doses<br />

80µg+4,5 µg /dose 60 doses;<br />

120 doses<br />

Hasco-Lek<br />

AstraZeneca<br />

AstraZeneca<br />

5215. Synalar Fluocinoloni acetonidum gel 0,025% 15g;30g Bioglan<br />

5216. Synalar Fluocinoloni acetonidum cream 0,025% 15g;30g Bioglan<br />

5217. Synalar Fluocinoloni acetonidum ointment 0,025% 15g;30g Bioglan<br />

5218. Syntostigmin Neostigmini methylsulphas solution for<br />

injection<br />

5219. Tabulettae Laxantes Cort.Frangulae+ Aloe+<br />

Fruct.Carvi+ Rad.Althaeae<br />

5220. TachoComb absorbable wound<br />

dressing<br />

5221. TachoComb absorbable wound<br />

dressing<br />

Human fibrinogen+ Bovine<br />

thrombin+ Bovine aprotinin+<br />

Riboflavin<br />

Human fibrinogen+ Bovine<br />

thrombin+ Bovine aprotinin+<br />

Riboflavin<br />

0,5mg/ml N10 amp. of 1ml Hoechst Biotika<br />

tab. 60mg+ 90mg+ 27mg+40mg<br />

N20<br />

coated dry<br />

foam fleece<br />

coated dry<br />

foam fleece<br />

5222. Tachystin liquidum Dihydrotachysterolum oral sol. 1mg/ml<br />

20ml<br />

(4,3-6,7)mg +(1,5-2,5)IU +<br />

(0,055-0,087) Ph.Eur.U+<br />

(7-26)µg/cm 2 (2,5×3×0,5cm)<br />

N1<br />

(4,3-6,7)mg+ (1,5-2,5)IU+<br />

(0,055-0,087) Ph.Eur.U+<br />

(7-26)µg/cm 3 (9,5×4,8× 0,5cm)<br />

N1<br />

ICN Polfa Rzeszow<br />

Nycomed Austria<br />

Nycomed Austria<br />

Chauvin ankerpharm<br />

5223. Tadenan 50 mg Pygeum africanum extract caps., soft 50mg N30 Fournier/Scherer/<br />

Urgo<br />

5224. Tafen Nasal Budesonidum nasal spray,<br />

susp.<br />

5225. Tafril-A Cefradinum powder for inj. 1g<br />

N1<br />

5226. Tagren Ticlopidinum coated tab. 250mg<br />

N30<br />

5<strong>227</strong>. Talc Haickhn 325 Mesch Ph.<br />

Eur.<br />

50µg/dose 200 doses LEK<br />

Polfa Tarchomin<br />

KRKA<br />

compos. subst. Mileage Products<br />

International


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 353<br />

No. Commercial name General name<br />

5228. Talion Extr. rad. cum herb. Taraxaci<br />

fl.(1:4) (Ethanolum 25%)<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

oral sol. 100g; 150g Herbapol Cracow<br />

5229. Tamifen Tamoxifenum tab. 10mg N30; N100; N1000 Medochemie<br />

5230. Tamiflu 12mg/ml Oseltamivirum powder for oral<br />

suspension<br />

12mg/ml 30g F.Hoffmann-La<br />

Roche AG<br />

5231. Tamiflu 75mg Oseltamivirum capsules, hard 75mg N10 F.Hoffmann-La<br />

Roche AG<br />

5232. Tamofen Tamoxifenum tab. 20mg N30 Leiras<br />

5233. Tamofen Tamoxifenum tab. 10mg N30 Leiras<br />

5234. Tamoksifeno 10 mg tablete˙s Tamoxifenum tab. 10mg<br />

N30<br />

5235. Tamoxifen Tamoxifenum tab. 20mg N30 Teva<br />

5236. Tamoxifen ‘Ebewe’ 10 mg Tamoxifenum tab. 10mg N30 Ebewe<br />

5237. Tamoxifen ‘Ebewe’ 20 mg Tamoxifenum tab. 20mg N30 Ebewe<br />

5238. Tanakan Extr. Ginkgo bilobae tab. 40mg<br />

N30;N90<br />

Endokrininiai<br />

preparatai<br />

Beaufour Ipsen<br />

5239. Tanakan Extr. Ginkgo bilobae oral sol. 40mg/ml Beaufour Ipsen<br />

5240. Tanatril Imidaprilum tablets 5mg Merck KgaA<br />

5241. Tanatril Imidaprilum tablets 10mg Merck KgaA<br />

5242. Tantum Rosa Benzydaminum gran. for sol. 500mg/sachets N10 Acraf<br />

5243. Tantum Verde Benzydaminum mouthwash 1,5mg/ml 60ml; 150ml Werfft-Chemie<br />

5244. Tantum Verde Benzydaminum lozenges 3mg N20 Acraf<br />

5245. Tantum Verde Benzydaminum toothpaste 5mg/g 60g Werfft-Chemie<br />

5246. Tantum Verde (Burnos<br />

purškalas)<br />

Benzydaminum sol. 1,5mg/ml 30ml Acraf<br />

5247. Taracef Cefaclorum gran. for oral<br />

susp.<br />

5248. Taracef Cefaclorum gran. for oral<br />

susp.<br />

250mg/5ml 60ml KRKA<br />

125mg/5ml 60ml KRKA<br />

5249. Taracef Cefaclorum caps. 250mg N16 KRKA<br />

5250. Taracef<br />

Taracef<br />

Cefaclorum<br />

Cefaclorum<br />

5251. Tarcefoksym Cefotaximum powder for sol.<br />

for inj.<br />

5252. Tardyferon Ferrous sulfate (eq. to Iron) sugar-coated<br />

slow-release<br />

tab.<br />

5253. Tarka 120/0,5 Verapamilum+ Trandolaprilum sustainedrelease<br />

caps.<br />

5254. Tarka 180/1 Verapamilum+ Trandolaprilum sustainedrelease<br />

caps.<br />

caps. 500mg N16 KRKA<br />

1g N250 Polfa Tarchomin<br />

80mg<br />

N30<br />

120mg+ 0,5mg N30; N50 Knoll<br />

180mg+ 1mg N30; N50 Knoll<br />

Progipharm


EN<br />

354 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5255. Tarka 180/2 Verapamilum+ Trandolaprilum sustainedrelease<br />

caps.<br />

5256. Tartephedreel Kalium stibyltartaricum D4+<br />

Hepatica nob. D3+ Atropa<br />

belladonna D4+Natrium sulf.<br />

D4+Arsenum jodat.D6+<br />

Quebracho D5+<br />

Naphtahalinum D6+ Betonica<br />

D2+Anisum stel.D3+Lobelia<br />

inflata D4+ IpecacuanhaD4+<br />

Blatta orient.D6+<br />

Medorrhinum-Nosode D8 +<br />

Ephedra dist.D3 ad sp. aeth.<br />

Strength Manufacturer<br />

180mg+ 2mg N28; N30; N50 Knoll<br />

drops 10g+10g+10g+10g+<br />

10g+10g+10g+5g+5g+ 5g+<br />

5g+5g+5g+5g/ 100g ad<br />

spiritus aethylicus 35% (V/V)<br />

5257. Tavanic 250 mg Levofloxacinum film-coated tab. 250mg<br />

N5; N7; N10; N14<br />

Heel<br />

Aventis Pharma<br />

5258. Tavanic 500 mg Levofloxacinum film-coated tab. 500mg N5; N7; N10; N14 Aventis Pharma<br />

5259. Tavanic i.v. 250 mg Levofloxacinum sol. for inf. 250mg/50ml bottle N1 Aventis Pharma<br />

5260. Tavanic i.v. 500 mg Levofloxacinum sol. for inf. 500mg/100ml bottle N1 Aventis Pharma<br />

5261. Tavegilio tablete˙s Clemastinum tab. 1 mg N20; N30 Liuks<br />

5262. Tavegyl Clemastinum sol. for inj. 1mg/ml<br />

2ml amp. N5<br />

5263. Tavegyl Clemastinum tab. 1mg<br />

N20<br />

5264. Taxol Paclitaxelum conc. for sol.<br />

for inf.<br />

5265. Taxotere Docetaxelum conc. and<br />

solvent for sol.<br />

for inf.<br />

5266. Taxotere Docetaxelum conc. and<br />

solvent for sol.<br />

for inf.<br />

5267. Tazepam Oxazepamum tab. 10mg<br />

N50<br />

5268. Tazocin 2 g Piperacillinum+<br />

Tazobactamum<br />

5269. Tazocin 4 g Piperacillinum+<br />

Tazobactamum<br />

5270. Tears Naturale Dextranum 70+<br />

Hydroxypropylmethylcellulosum<br />

powder for sol.<br />

for inj.<br />

powder for sol.<br />

for inj.<br />

6mg/ml 5ml<br />

(30mg);17ml (100mg);50ml<br />

(300mg)<br />

20mg/0,5ml vial+solvent (13%<br />

w/w ethanol in water for inj.<br />

1,83ml) N1<br />

80mg/2ml vial+solvent (13%<br />

w/w ethanol in water for inj.<br />

7,33ml) N1<br />

2g+250mg<br />

2g N1<br />

5271. Tegretol 200 Carbamazepinum tab. 200mg<br />

N50<br />

5272. Tegretol 400 Carbamazepinum tab. 400mg<br />

N30<br />

5273. Tegretol CR 200 Carbamazepinum slow-release<br />

film-coated tab.<br />

5274. Tegretol CR 400 Carbamazepinum slow-release<br />

film-coated tab.<br />

Nycomed Austria<br />

Novartis Pharma<br />

Bristol-Myers Squibb<br />

Aventis Pharma<br />

Aventis Pharma<br />

Polfa Tarchomin<br />

Wyeth Lederle/<br />

Lederle Piperacillin<br />

4g+0,5g Wyeth Lederle/<br />

Lederle Piperacillin<br />

eye drops,sol. 1mg+3mg/ml 15ml Alcon-Couvreur<br />

200mg<br />

N50<br />

400mg<br />

N30<br />

Novartis Farma<br />

Novartis Farma<br />

Novartis Farma<br />

Novartis Farma<br />

5275. Telfast Fexofenadini hydrochloridum film-coated tab. 120mg N20 Hoechst Marion


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 355<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5276. Telfast Fexofenadini hydrochloridum film-coated tab. 180mg N20 Hoechst Marion<br />

5277. Temodal Temozolomidum capsules, hard 100mg N5;N20 Schering-Plough<br />

Labo N.V.<br />

5278. Temodal Temozolomidum capsules, hard 20mg N5;N20 Schering-Plough<br />

Labo N.V.<br />

5279. Temodal Temozolomidum capsules, hard 250mg N5;N20 Schering-Plough<br />

Labo N.V.<br />

5280. Temodal 5mg Temozolomidum capsules, hard 5mg N5;N20 Schering-Plough<br />

Labo N.V.<br />

5281. Temperolis Extractum fluidum<br />

compositum ex:Verbasci flos +<br />

Tiliae inflorescentia+ Salicis<br />

cortex+Sambuci flos<br />

(Ethanolum 95%)<br />

sir. 10g:1,018g+1,222g+<br />

0,611g+1,222g/100g (3,344g)<br />

125g<br />

5282. Tenaxum Rilmenidinum tab. 1mg N30 Servier<br />

5283. Tenormin Atenololum film-coated tab. 50mg<br />

N14; N28; N500<br />

5284. Tenormin Atenololum film-coated tab. 100mg<br />

N14; N28; N500<br />

Hasco-Lek<br />

5285. Tenox Amlodipinum tablets 5mg N30 KRKA /KRKA Polska<br />

5286. Tenox Amlodipinum tablets 10mg N30 KRKA /KRKA Polska<br />

5287. Tensiton Dextranum+ Natrii chloridum sol.for inf. 60g+ 75g/1000ml 500ml Infusia<br />

5288. Teopeks 300 mg Theophyllinum prolongedrelease<br />

tab.<br />

5289. Teotard 200 Theophyllinum sustainedrelease<br />

caps.<br />

5290. Teotard 350 Theophyllinum prolongedrelease<br />

caps.<br />

5291. Tepalas nuo nuospaudu˛ Acidum salicylicum +<br />

Emplastrum Mellilotti<br />

Zeneca<br />

Zeneca<br />

300mg N50 OlainFarm<br />

200mg<br />

N40<br />

KRKA<br />

350mg N40 KRKA<br />

ointment 50 partis+50 partis 10g;20g Gemi<br />

5292. Terbisil 250 mg Terbinafinum tab. 250mg<br />

N14; N28<br />

5293. Terbisil 1 % Terbinafinum cream 10mg/g<br />

15g<br />

5294. Terbisil Kid Terbinafinum tab. 125mg<br />

N14<br />

5295. Tercef Ceftriaxonum powder for sol.<br />

for inj.<br />

Gedeon Richter<br />

Gedeon Richter<br />

Gedeon Richter<br />

1g/bottle N1; N5 Balkanpharma-<br />

Razgrad<br />

5296. Tercef Ceftriaxonum powder for inj. 2g/ bottle N1; N5 Balkanpharma-<br />

Razgrad<br />

5297. Terfenadin 60 Stada Terfenadinum tab. 60mg N20; N50; N100 Stada<br />

5298. Terizidon Terizidonum capsules 250mg N50 Fatol Arzneimittel<br />

GmbH<br />

5299. Terpentino 20 % tepalas Ol.Terebinthinae rectificatum ointment 20g/100g 25g Sanitas


EN<br />

356 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5300. Tertensif Indapamidum film-coated tab. 2,5mg<br />

N30<br />

5301. Tertensif SR Indapamidum sustainedrelease<br />

coated<br />

tab.<br />

5302. Tetaglobuline Human tetanus<br />

immunoglobulin<br />

1,5mg<br />

N30<br />

Strength Manufacturer<br />

Servier<br />

Servier<br />

sol. for inj. > or =250IU/ml Pasteur Merieux<br />

5303. Tetavax Tetanus toxoid susp. for inj. at least 40IU/0,5ml syringe<br />

N1; 0,5ml amp.N20<br />

5304. Tetraciklino tablete˙s Tetracyclinum tab. 0,1 g N20 Liuks<br />

5305. Tetracoq (adsorbed diphtheria,<br />

pertussis, tetanus and<br />

inactivated poliomyelitis<br />

vaccine)<br />

5306. TETRAct-HIB (Vaccine against<br />

diphtheria, tetanus, meningitis<br />

caused by type b Haemophilus<br />

influenzae)<br />

Diphtheria toxoid+ Tetanus<br />

toxoid+ Bordetella pertussis,<br />

inactivated+ Inactivated type 1<br />

poliovirus D antigen+<br />

Inactivated type 2 poliovirus D<br />

antigen+ Inactivated type 3<br />

poliovirus D antigen<br />

Powder:Type b Haemophilus<br />

influenzae polysaccharide<br />

conjugated with tetanus<br />

protein; Suspension (as<br />

diluent): Purified diphtheria<br />

toxoid+ Purified tetanus<br />

toxoid+ Bordetella<br />

pertussis,inactivated<br />

susp. for inj. >30IU+ >60IU+ >4IU+<br />

40units+8units+ 32units/0,5ml<br />

single dose pre-filled syringes<br />

N1;N20<br />

powder and<br />

susp.for susp.<br />

for inj.<br />

10µg/vial; >30IU+ >60IU+<br />

>4IU/0,5ml pre-filled syringe<br />

N1<br />

5307. Tetracyclinum ung 3% Tetracyclinum ointment 3%, 15,0g Liuks<br />

5308. Tetracyclinum ung ophth 1% Tetracyclinum ung. opth 1%, 3g, 10g Liuks<br />

5309. Tetratusinas Kalii bromidum+ Natrii<br />

benzoas+ Ammonii<br />

chloridum+ Extr. Thermopsidis<br />

fl.(1:2)+ Extr. Glycyrrhizae<br />

spiss. +Ethanolum 90 %<br />

5310. Tetraxim Diphtheria toxoid+ Tetanus<br />

toxoid+ Pertussis toxoid+<br />

Filamentous haemagglutinin+<br />

Inactivated type 1poliovirus D<br />

antigen+Inactivated type 2<br />

poliovirus D antigen+<br />

Inactivated type 3 poliovirus D<br />

antigen<br />

syrup 1g+1g+ 0,2g+0,2g+ 0,6g+<br />

10g/100g<br />

susp. for inj. 30IU+40IU+ 25µg+25µg+<br />

40units+ 8units+ 32units/dose<br />

(0,5ml) N1;N10<br />

5311. Teturamas Tetraetiltiuram-disulfidum tab. 0,15 g N10 Liuks<br />

Pasteur Merieux<br />

Pasteur Merieux<br />

Pasteur Merieux<br />

Vilniaus farmacijos<br />

fabrikas<br />

Pasteur Merieux<br />

5312. Teveten 400 Eprosartanum film-coated tab. 400mg N14; N28; N56 Solvay<br />

Pharmaceuticals<br />

5313. Teveten 600 Eprosartanum film-coated tab. 600mg N14; N28; N56 Solvay<br />

Pharmaceuticals<br />

5314. Theotard 300 Theophyllinum sustainedrelease<br />

caps.<br />

5315. Theracap 131 (Sodium Iodide<br />

[ 131 I] Therapy Capsule)<br />

300mg N30 CTS<br />

Sodium iodide [ 131 I] caps. 37-5550 MBq 37-740 MBq in<br />

37 MBq steps; 50-1000 MBq<br />

in 50 MBq steps;<br />

0,925-5,55 GBq in 185 MBq<br />

steps; 1000-5500 MBq in<br />

100 MBq steps<br />

Nycomed Amersham


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 357<br />

No. Commercial name General name<br />

5316. TheraFlu (nuo peršalimo ir<br />

gripo simptomu˛)<br />

5317. TheraFlu (nuo peršalimo, gripo<br />

simptomu˛ ir kosulio)<br />

5318. TheraFlu (nuo peršalimo, gripo<br />

simptomu˛ ir kosulio. Stipraus<br />

poveikio, nakties metu)<br />

5319. TheraFlu (nuo peršalimo, gripo<br />

simptomu˛ ir kosulio. Stipraus<br />

poveikio, nesukelia<br />

mieguistumo)<br />

5320. Thera-M Vitamins and<br />

Minerals with Beta Carotene<br />

Paracetamolum+<br />

Pseudoephedrinum+<br />

Chlorphenaminum<br />

Paracetamolum+<br />

Pseudoephedrinum+<br />

Chlorphenaminum+<br />

Dextromethorphani<br />

hydrobromidum<br />

Paracetamolum+<br />

Pseudoephedrinum+<br />

Chlorphenaminum+<br />

Dextromethorphani<br />

hydrobromidum<br />

Paracetamolum+<br />

Pseudoephedrinum+<br />

Dextromethorphani<br />

hydrobromidum<br />

Vit.A+Ascorbic acid +Vit.D+<br />

Thiamine+ Riboflavin+<br />

Niacinamide+ Pyridoxine+<br />

Cyanocobalamin+<br />

Tocopherol+Folic acid+<br />

Pantothenic acid+Biotin+<br />

Iodine+Iron+Magnesium+<br />

Copper+Zinc+Manganese+<br />

Calcium+ Selenium+<br />

Chromium+Molybdenum+<br />

Phosphorus+Potassium+<br />

Chloride<br />

5321. Thioctacid 100 T Trometamol salt of alfa-Lipoic<br />

acid<br />

5322. Thioctacid 600 T Trometamol salt of alfa-Lipoic<br />

acid<br />

Pharmaceutical<br />

form<br />

powder for oral<br />

sol.<br />

powder for oral<br />

sol.<br />

powder for oral<br />

sol.<br />

powder for oral<br />

sol.<br />

Strength Manufacturer<br />

650mg+60mg+4mg/ sachets<br />

N6; N12<br />

650mg+60mg+4mg+<br />

20mg/sachets<br />

N6; N12<br />

1 000mg +60mg+4mg+<br />

30mg/sachets<br />

N6; N12<br />

1 000mg +60mg+<br />

30mg/sachets<br />

N6; N12<br />

tab. 5000IU+90mg+400IU+ 3mg+<br />

3,4mg+20mg+ 3mg+9µg+<br />

30IU+0,4mg+<br />

10mg+30µg+150µg+ 27mg+<br />

100mg+2mg+<br />

15mg+ 5mg+40mg+ 10µg+<br />

15µg+ 15µg+31mg+ 7,5mg+<br />

7,5mg N100<br />

Patheon Whitby<br />

Patheon Whitby<br />

Patheon Whitby<br />

Patheon Whitby<br />

Contract Pharmacal<br />

sol. for inj. 100mg/4ml N10; N20 Asta Medica<br />

sol. for inj. 600mg/24ml N5;N10;N20 Asta Medica<br />

5323. Thioctacid 200 Acidum alfa-lipoicum film-coated tab. 200mg N30;100 Asta Medica<br />

5324. Thioctacid 600 Acidum alfa-lipoicum film-coated tab. 600mg N30;60;100 Asta Medica<br />

5325. Thiogamma 300 Injekt N Acidum alfa-lipoicum sol. for inj. i.v. 300mg/10ml N5 Worwag Pharma<br />

5326. Thiogamma 300 oral Acidum alfa-lipoicum caps. 300mg N30 Worwag Pharma<br />

5327. Thiogamma 600 Injekt Acidum alfa-lipoicum (Acidum<br />

tiocticum)<br />

5328. Thiogamma 600 oral Acidum alfa-lipoicum (Acidum<br />

tiocticum)<br />

5329. Thiogamma Turbo-Set Acidum alfa-lipoicum (Acidum<br />

tiocticum)<br />

5330. Thiopental 1 g Thiopentalum natricum powder for sol.<br />

for inj.<br />

5331. Thiopental 0,5 g Thiopentalum natricum powder for<br />

sol.for inj.<br />

5332. Thiopental inj. ICN Thiopentalum natricum powder for sol.<br />

for inj.<br />

5333. Thiopental inj. ICN Thiopentalum natricum powder for sol.<br />

for inj.<br />

sol. for inj. 600mg/20ml amp. N5; N10;<br />

N20<br />

Solupharm<br />

film-coated tab. 600mg N30; N60; N100 Artesan Pharma<br />

sol. for inf. 600mg/50ml vial N1; N10 Solupharm<br />

1g<br />

N25<br />

500mg<br />

N25<br />

Biochemie<br />

Biochemie<br />

500mg/vial N1 ICN Czech Republic<br />

1g/vial<br />

N1<br />

ICN Czech Republic


EN<br />

358 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5334. Thrombo ASS Acidum acetylsalicylicum film-coated tab. 50mg<br />

N100<br />

5335. Thrombo ASS Acidum acetylsalicylicum film-coated tab. 100mg<br />

N30<br />

Strength Manufacturer<br />

Lannacher<br />

Lannacher<br />

5336. Thromboreductin Anagrelidum capsules 0,5mg N100 AOP Orphan<br />

Pharmaceuticals<br />

5337. Thyrozol 5 Thiamazolum film-coated tab. 5mg<br />

N50<br />

5338. Tiamino chlorido (Vitamino<br />

B1) 2,5 % tirpalas injekcijoms<br />

5339. Tiamino chlorido (Vitamino<br />

B1) 5 % tirpalas injekcijoms<br />

5340. Tiamino chlorido 5 % tirpalas<br />

injekcijoms<br />

Thiaminum sol. for inj. 25mg/ml amp.<br />

N10<br />

Thiaminum sol. for inj. 50mg/ml amp.<br />

N10<br />

Thiaminum sol. for inj. 50mg/ml<br />

N10<br />

5341. Tiapridal Tiapridum oral drops,<br />

solution<br />

Merck<br />

Endokrininiai<br />

preparatai<br />

Endokrininiai<br />

preparatai<br />

Sanitas<br />

5mg/drop (0,036ml) 30ml Synthelabo<br />

5342. Tiapridal Tiapridum sol. for inj. 100mg/2ml amp. N12 Synthelabo<br />

5343. Tiapridal Tiapridum scored tab. 100mg N20 Synthelabo<br />

5344. Tiberal Ornidazolum film-coated tab. 500mg<br />

N10<br />

5345. Ticlid 250 mg Ticlopidinum coated tab. 250mg<br />

N20<br />

Roche<br />

Sanofi Winthrop<br />

5346. Ticlopidine Poli Ticlopidinum film-coated tab. 250mg N30 Poli Industria<br />

Chimica<br />

5347. Ticlopidin-ratiopharm Ticlopidini hydrochloridum film-coated tab. 250mg N30 Merckle<br />

5348. Tienam Imipenemum+ Cilastatinum powder for sol.<br />

for inf. i.v.<br />

5349. Tienam Imipenemum+ Cilastatinum powder for sol.<br />

for inj. i.m.<br />

500mg+ 500mg N5 MSD-Haarlem<br />

500mg+ 500mg N1 MSD-Haarlem<br />

5350. Tifol Acidum folicum film-coated tab. 0,4mg N30;N60 KRKA<br />

5351. Tiger Balm Red Camphora+ Mentholum+<br />

Ol.Cajeputi+ Ol.Mentae<br />

(dementholised)+<br />

Ol.Cinnamomi cassia+<br />

Ol.Caryophylli<br />

5352. Tiger Balm White Ol.Eucalypti+ Ol.Caryophylli+<br />

Mentholum+ Ol.Menthae+<br />

Camphora<br />

ointment 10mg+ 100mg+ 70mg+<br />

60mg+ 50mg+ 50mg/g 19,4g<br />

5353. Tilade Nedocromilum pressured inhal. 2mg/dose<br />

112 doses<br />

5354. Tilade Mint/Tilade Mint<br />

Synchroner<br />

Nedocromilum metered dose<br />

pressurized<br />

aerosol<br />

Tiger Medicals<br />

ointment 15%+10%+7%+7%+2% 19g Tiger Medicals<br />

2mg/ actuation 56 doses; 112<br />

doses<br />

5355. Tilarin Nedocromilum nasal spray 1% 15ml Fisons<br />

5356. Tilavist Nedocromilum eye drops 2% 5ml Fisons<br />

Rhone-Poulenc<br />

Rorer<br />

Fisons


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 359<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5357. Tim-Alcon Timololum eye drops 2,5mg/ml<br />

5ml<br />

5358. Tim-Alcon Timololum eye drops 5mg/ml<br />

5ml<br />

Strength Manufacturer<br />

5359. Timohexal Timololum eye drops 2,5mg/ml 5ml N1;N3 Hexal<br />

5360. Timohexal Timololum eye drops 5mg/ml 5ml Hexal<br />

5361. Timonil 150 retard Carbamazepinum sustainedrelease<br />

tab.<br />

150mg<br />

N50; N100<br />

5362. Timonil 200 Carbamazepinum tab. 200mg<br />

N50; N100<br />

5363. Timonil 300 retard Carbamazepinum sustainedrelease<br />

tab.<br />

5364. Timonil 600 retard Carbamazepinum sustainedrelease<br />

tab.<br />

300mg<br />

N50; N100<br />

600mg<br />

N50; N100; N200<br />

Alcon-Couvreur<br />

Alcon-Couvreur<br />

5365. Timonil Saft Carbamazepinum oral susp. 100mg/5ml 250ml Haupt Pharma /<br />

Desitin<br />

5366. Timoptic Timololum eye drops, sol. 5mg/ml 5ml MSD-Haarlem<br />

5367. Timoptic Timololum eye drops, sol. 2,5mg/ml 5ml MSD-Haarlem<br />

5368. Timoptic-XE 0,25 % Timololum eye drops,<br />

gellan sol.<br />

5369. Timoptic-XE 0,5 % Timololum eye drops,<br />

gellan sol.<br />

Desitin<br />

Desitin<br />

Desitin<br />

Desitin<br />

2,5mg/ml 2,5ml MSD<br />

5mg/ml 2,5ml MSD<br />

5370. Timosan Timololum eye gel 1mg/g 5g Ciba Vision<br />

5371. Timpilo 2 Timololum+ Pilocarpinum eye drops, sol. 5mg+22,6mg /ml 5ml two<br />

chamber bottle N1<br />

5372. Timpilo 4 Timololum+ Pilocarpini<br />

hydrochloridum<br />

5373. Tinctura Ginkgo Bilobae Ginkgo bilobae tinctura (1:5)(<br />

Ethanolum 60-70%)<br />

eye drops,sol. 5mg+45,2mg /ml 5ml two<br />

chamber bottle N1<br />

MSD<br />

MSD<br />

tinct. 30g; 100g Herbapol Kle˛ka<br />

5374. Tinctura Valerianae Valerianae radicis tinct. 200partis Ethanolum 95%<br />

partis 35g<br />

5375. Tinidazol Tinidazolum film-coated tab. 500mg<br />

N4<br />

5376. Tinidazol Tinidazolum coated tab. 500mg<br />

N4<br />

Hasco-Lek<br />

Balkanpharma-<br />

Dupnitza<br />

Polpharma<br />

5377. Tinktūra Neurokardialis compos. extract 50ml Korio laboratorija<br />

UAB<br />

5378. Tinktūra Neuroventralis 2 compos. tincture 50ml Korio laboratorija<br />

UAB<br />

5379. Tinktūra Neuroventralis1 compos. tincture 50ml Korio laboratorija<br />

UAB<br />

5380. Tireoidino 100mg tablete˙s Thyreoidinum tab. 100mg<br />

N30; N50<br />

Endokrininiai<br />

preparatai<br />

5381. Tirlor Loratadinum tablets 10mg N30 Novartis Bangladesh<br />

Ltd


EN<br />

360 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5382. Tisercin Levomepromazinum film-coated tab. 25mg N50 Egis<br />

5383. Tisercin injection Levomepromazinum sol. for inj./inf. 25mg/ml 1ml amp. N10 Egis<br />

5384. Titralgan Quick Paracetamolum efferv. tab. 500mg Berlin-Chemie<br />

(Menarini Group)<br />

5385. Tobradex Tobramycinum+<br />

Dexamethasonum<br />

5386. Tobrex Tobramycinum eye drops,<br />

sol.<br />

5387. Tobrex Tobramycinum eye ointment 3mg/g<br />

3,5g<br />

5388. Tobrin Tobramycinum eye drops, sol. 3mg/ml<br />

5ml<br />

eye drops, susp. 3mg+ 1mg/ml 5ml Alcon-Couvreur<br />

3mg/ml 5ml Alcon-Couvreur<br />

Alcon-Couvreur<br />

Balkanpharma-<br />

Razgrad<br />

5389. Tobrin Tobramycinum eye ointment 3mg/g 5g Balkanpharma-<br />

Razgrad<br />

5390. Toclase Pentoxyverinum supp. 8mg<br />

N12<br />

5391. Toclase Pentoxyverinum supp. 20mg<br />

N12<br />

5392. Toclase Pentoxyverinum film-coated tab. 50mg<br />

N50<br />

5393. Toclase Pentoxyverinum syrup 1,5mg/ml 200ml; 500ml UCB<br />

5394. Toclase Pentoxyverinum oral drops 30mg/ml 30ml UCB<br />

5395. Toclase S Pentoxyverinum oral sol. 10,65mg/ 5ml 200ml; 500ml UCB<br />

UCB Pharma<br />

UCB Pharma<br />

UCB Pharma<br />

5396. Tocofer-200 Tocopherolum caps.,soft 200mg N100 Torrent<br />

5397. Tocofer-400 Tocopherolum caps.,soft 400mg N100 Torrent<br />

5398. Tolnaftato 1 % tepalas Tolnaftatum ointment 10mg/g<br />

25g<br />

5399. Tomapyrin Comfort Acidum acetylsalicylicum chewable tab. 500mg<br />

N10; N20<br />

5400. Tomudex Raltitrexed powder for<br />

sol.for inf.<br />

5401. Toncils Chlorhexidinum+<br />

Benzocainum<br />

5402. Toncils Blackcurrant Chlorhexidinum +<br />

Benzocainum<br />

5403. Toncils Lemon Chlorhexidinum +<br />

Benzocainum<br />

Sanitas<br />

Pfleger/ Boehringer<br />

Ingelheim<br />

2mg/vial N1 Ben Venue<br />

Laboratories/ Zeneca<br />

suckable tab. 5mg+2mg N20 Vitabalans<br />

lozenges 5mg+2mg N24 Vitabalans OY<br />

lozenges 5mg+2mg N24 Vitabalans OY<br />

5404. Toncils Peppermint Chlorhexidin +Benzocainum lozenges 5mg+2mg Vitabalans OY<br />

5405. Toning-up Tablets Crataegi inflorescentia+<br />

Crataegi fructus + Leonuri<br />

herba +Meliloti herba<br />

tab. 150mg+ 30mg+ 100mg+<br />

40mg N20;N60<br />

Labofarm


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 361<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5406. Tonocalcin Calcitoninum salmonis nasal spray, sol. 200IU/dose 14 doses Alfa Wasser-mann<br />

5407. Tonsilgon N Althaeae radix+ Chamomilae<br />

flos+ Equiseti herba+ Juglandis<br />

folium+ Millefolii herba+<br />

Quercus cortex+ Taraxaci<br />

herba<br />

5408. Tonsilotren Atropinum sulfuricum D5+<br />

Hepar sulfuris D3+Kalium<br />

bichromicum D4+Silicea D2+<br />

Mercurius bijodatus D8<br />

5409. Tonussan Rhiz. cum rad. Eleutherococci<br />

(Ethanolum 40%)<br />

oral drops sol. 4mg+3mg+<br />

5mg+4mg+<br />

4mg+2mg+ 4mg/g (Ethanolum<br />

19% (V/V)) 50ml<br />

tab. 12,5mg+10mg+50mg+ 5mg+<br />

25mg<br />

N60<br />

Bionorica<br />

DHU<br />

elexir 100g (ad 1l) 40ml; 50ml Bakteriniai<br />

preparatai<br />

5410. Topamax Topiramatum tab. 300mg N20;N50; N60;N100 Cilag<br />

5411. Topamax Topiramatum tab. 400mg N20;N50; N60;N100 Cilag<br />

5412. Topamax Topiramatum tab. 200mg N20;N28; N50;N60;<br />

N100<br />

5413. Topamax Topiramatum tab. 100mg N20;N28; N50;N60;<br />

N100<br />

5414. Topamax Topiramatum tab. 50mg N20;N28; N50;N60;<br />

N100<br />

5415. Topamax Topiramatum tab. 25mg N20;N28; N50;N60;<br />

N100<br />

5416. Topamax 15 mg Topiramatum sprinkle caps.,<br />

hard<br />

5417. Topamax 25 mg Topiramatum sprinkle caps.,<br />

hard<br />

Cilag<br />

Cilag<br />

Cilag<br />

Cilag<br />

15mg N60 Janssen-Cilag<br />

25mg N60 Janssen-Cilag<br />

5418. Topcid-20 Famotidinum fim-coated tab. 20mg N100 Torrent<br />

5419. Topcid-40 Famotidinum film-coated tab. 40mg N100 Torrent<br />

5420. Torlasporine Cefalexinum caps. 500mg<br />

N10<br />

5421. Tot`Hema Ferrosi gluconas +Manganesii<br />

gluconas+Cupri gluconas<br />

oral sol. 50mg+1,33mg+0,7mg/ 10ml<br />

amp.<br />

N20<br />

5422. Trabar-100 Tramadolum sol. for inj. 100mg/2ml amp. N5 Mepha<br />

5423. Trabar-50 Tramadolum caps. 50mg N10; N20 Mepha<br />

5424. Trabar-Drops Tramadolum oral drops 100mg/ml 10ml Mepha<br />

5425. Trachisan pastile˙s Tyrothricinum+ Lidocainum+<br />

Chlorhexidinum<br />

Lab. Torlan<br />

Innothera<br />

lozenges 0,5mg+ 1mg+1mg N20 Engelhard<br />

5426. Tracrium Atracurii besilas sol. for inj. 25mg/2,5ml amp. N5 Wellcome<br />

5427. Tracrium Atracurii besilas sol. for inj. 50mg/5ml amp. N5 Wellcome<br />

5428. Tradelia Estradiolum transdermal<br />

patch<br />

5429. Tradelia Estradiolum transdermal<br />

patch<br />

50µg/24h (4mg/18cm 2 ) N8 LTS<br />

25µg/24h (2mg/9cm 2 ) N8 LTS


EN<br />

362 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5430. Tradelia Estradiolum transdermal<br />

patch<br />

5431. Tralgit SR 100 Tramadolum prolongedrelease<br />

tab.<br />

Strength Manufacturer<br />

100µg/24h (8mg/36cm 2 ) N8 LTS<br />

100mg<br />

N10; N30; N50<br />

Slovakofarma<br />

5432. Tramadol Tramadolum sol. for inj. 100mg/2ml amp. 2ml N5 Pliva Krakow<br />

5433. Tramadol Tramadolum oral drops, sol. 100mg/ml<br />

10ml<br />

Lannacher<br />

5434. Tramadol Tramadolum supp. 100mg N5 Lannacher<br />

5435. Tramadol Tramadolum sol. for inj. 50mg/ml amp.1ml N5 Pliva Krakow<br />

5436. Tramadol Tramadolum film-coated tab. 50mg<br />

N20<br />

5437. Tramadol Tramadolum sol. for inj. 100mg/2ml<br />

N5<br />

5438. Tramadol Tramadolum sol. for inj. 50mg/ml<br />

N5<br />

Lannacher<br />

Lannacher<br />

Lannacher<br />

5439. Tramadol Tramadolum caps. 50mg N20 Synteza<br />

5440. Tramadol Tramadolum oral drops, sol 100mg/ml 10ml Synteza<br />

5441. Tramadol Tramadolum supp. 100mg<br />

N5<br />

5442. Tramadol Tramadolum sol. for inj. 50mg/ml<br />

1ml amp.<br />

N5<br />

5443. Tramadol Tramadolum sol. for inj. 100mg/2ml 2ml amp.<br />

N5<br />

5444. Tramadol Tramadolum oral drops, sol. 100mg/ml 10ml KRKA<br />

5445. Tramadol Tramadolum caps. 50mg<br />

N20<br />

5446. Tramadol 100 Slovakofarma Tramadolum supp. 100mg N10 Slovakofarma<br />

5447. Tramadol 50 Slovakofarma Tramadolum caps. 50mg N10; N20 Slovakofarma<br />

5448. Tramadol 50 Stada Tramadolum caps. 50mg N10; N30; N50 Stada<br />

5449. Tramadol Alpharma Capsules<br />

50mg<br />

5450. Tramadol Lannacher retard<br />

100 mg<br />

5451. Tramadol Lannacher retard<br />

150 mg<br />

5452. Tramadol Lannacher retard<br />

200 mg<br />

KRKA<br />

KRKA<br />

KRKA<br />

KRKA<br />

Tramadolum capsules 50mg N30 Alpharma Limited<br />

Tramadolum prolongedreleasefilmcoated<br />

tab.<br />

Tramadolum prolongedreleasefilmcoated<br />

tab.<br />

Tramadolum prolongedreleasefilmcoated<br />

tab.<br />

5453. Tramadol Retard Tramadolum prolongedrelease<br />

tab.<br />

100mg<br />

N10; N30<br />

150mg<br />

N10; N30<br />

200mg<br />

N10; N30<br />

100mg<br />

N30<br />

Lannacher<br />

Lannacher<br />

Lannacher<br />

5454. Tramadol Slovakofarma Tramadolum oral drops, sol. 1g/10ml 10ml Slovakofarma<br />

KRKA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 363<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5455. Tramadol Stada Tramadolum sol. for inj. 100mg/2ml amp. N5; N10;<br />

N20<br />

Strength Manufacturer<br />

5456. Tramadol Stada Tramadolum oral drops, sol. 100mg/ml 10ml; 20ml; 50ml;<br />

100ml<br />

5457. Tramadolio 50 mg tablete˙s Tramadolum tab. 50 mg N10; N20; N30; N50 Liuks<br />

5458. Tramadolio 5% tirpalas<br />

injekcijoms<br />

5459. Tramadolio hidrochlorido<br />

50mg/ml tirpalas injekcijoms<br />

5460. Tramadolio hidrochlorido<br />

50mg/ml tirpalas injekcijoms<br />

Stada<br />

Stada<br />

Tramadolum sol. for inj. 100mg/2ml amp. N10 Endokrininiai<br />

preparatai<br />

Tramadolum sol. for inj. 50mg/ml 1ml amp. N5;N10 Sanitas<br />

Tramadolum sol. for inj. 100mg/2ml amp. N5;N10 Sanitas<br />

5461. Tramadolor Tramadolum caps. 50mg N10; N30; N50 Salutas<br />

5462. Tramadolor Tramadolum supp. 100mg<br />

N10; N20<br />

5463. Tramadolor Tramadolum (Ethanolum 96%) oral drops, sol. 100mg/ml (161,8mg/ml)<br />

10ml; 30ml; 50ml<br />

Salutas<br />

Salutas<br />

5464. Tramadolor 100 Tramadolum sol. for inj. 100mg/2ml amp. N5 Salutas<br />

5465. Tramadolor 100 ID Tramadolum extended-release<br />

tab.<br />

5466. Tramadolor 150 ID Tramadolum prolongedrelease<br />

tab.<br />

5467. Tramadolor 200 ID Tramadolum prolongedrelease<br />

tab.<br />

100mg<br />

N10; N30; N50<br />

Salutas<br />

150mg N10; N30; N50 Salutas<br />

200mg N10; N30; N50 Salutas<br />

5468. Tramadolor 50 Tramadolum sol. for inj. 50mg/ml 1ml amp. N5 Salutas<br />

5469. Tramadolor Brause Tramadolum efferv. tab. 50mg N10; N30; N50 Salutas<br />

5470. Tramadolor tabs Tramadolum tab. 50mg N10; N30; N50 Salutas<br />

5471. Tramadol-Slovakofarma Tramadolum sol.for inj. 50mg/ml 1ml amp.N5 Slovakofarma<br />

5472. Tramadol-Slovakofarma Tramadolum sol.for inj. 100mg/2ml amp.N5 Slovakofarma<br />

5473. Tramagit drops Tramadolum oral drops,<br />

solution<br />

5474. Tramal Tramadolum supp. 100mg<br />

N5<br />

5475. Tramal 50 Tramadolum sol. for inj. 50mg/ml<br />

1ml amp.<br />

N5<br />

5476. Tramal capsules Tramadolum caps. 50mg<br />

N20<br />

100mg/ml 10ml;20ml Krewel Meuselbach<br />

Grunenthal<br />

Grunenthal<br />

Grunenthal<br />

5477. Tramal drops Tramadolum oral drops, sol. 100mg/ml 10ml Grunenthal<br />

5478. Tramal retard Tramadolum film-coated tab. 200mg N10; N30; N50 Grunenthal<br />

5479. Tramal retard Tramadolum film-coated tab. 100mg N10; N30; N50 Grunenthal<br />

5480. Tramal retard Tramadolum film-coated tab. 150mg N10; N30; N50 Grunenthal<br />

5481. Tramal Retard 100 Tramadolum coated tab. 100mg N10; N30; N50 Polpharma


EN<br />

364 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5482. Tramal Retard 150 Tramadolum coated tab. 150mg N10; N30; N50 Polpharma<br />

5483. Tramal Retard 200 Tramadolum coated tab. 200mg N10; N30; N50 Polpharma<br />

5484. Tramazac Tramadolum caps. 50mg N100 Cadila<br />

5485. Trandate Labetalolum sol. for inj. 5mg/ml<br />

20ml amp. N5<br />

5486. Trandate Labetalolum tab. 200mg<br />

N50<br />

5487. Trandate Labetalolum tab. 100mg<br />

N50<br />

5488. Transpulmin balsam S for<br />

children<br />

Eucalyptus oil+ Pineneedle oil cream 100mg+ 30mg/1g 20g; 40g;<br />

100g<br />

5489. Tranxene 100 mg/5 ml Dikalii clorazepas powder and<br />

solvent for sol.<br />

for inj.<br />

5490. Tranxene 20 mg/2 ml Dikalii clorazepas powder and<br />

solvent for sol.<br />

for inj<br />

100mg/5ml<br />

N5<br />

20mg/2ml<br />

N5; N20<br />

5491. Tranxene 50 mg Dikalii clorazepas film-coated tab. 50mg<br />

N30<br />

5492. Tranxene 50 mg/2,5 ml Dikalii clorazepas powder and<br />

solvent for sol.<br />

for inj.<br />

5493. Tranxene 10 mg Dikalii clorazepas caps. 10mg<br />

N30<br />

5494. Tranxene 5 mg Dikalii clorazepas caps. 5mg<br />

N30<br />

5495. Traumasept Losung Povidonum iodinatum<br />

(Polyvidonum)<br />

5496. Traumasept Vaginal-Ovula Povidonum iodinatum<br />

(Polyvidonum)<br />

5497. Traumasept Wundgel Povidonum iodinatum<br />

(Polyvidonum)<br />

5498. Traumeel S Arnica D2+<br />

Calendula D2+<br />

Chamomilla D3+<br />

Symphytum D6+<br />

Achilla millefolium D3+<br />

Atropa belladona D2+<br />

Aconitum D2+Bellis perennis<br />

D2+<br />

Hypericum D2+<br />

Echinacea angustifolia D2+<br />

Echinacea purpurea D2+<br />

Hamamelis virginiana D1+<br />

Mercurius solubilis+<br />

Hahnemanni D6<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Asta Medica<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

50mg/2,5ml N5; N20 Sanofi Winthrop<br />

sol. 100mg/ml 30ml Wolff<br />

vaginal supp. 200mg N10 Wolff<br />

gel 10g/100g 25g;100g Wolff<br />

sol. for inj. 2,2µl+2,2µl+<br />

2,2µl+2,2µl+<br />

2,2µl+2,2µl+<br />

1,32µl+1,1µl+<br />

0,66µl+0,55µl +0,55µl+<br />

0,22µl+1,1mg+<br />

2,2µl/2,2ml amp. N10<br />

Sanofi Winthrop<br />

Sanofi Winthrop<br />

Heel


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 365<br />

No. Commercial name General name<br />

5499. Traumeel S Arnica D2 +Calendula D2+<br />

Hamamelis D2+ Millefolium<br />

D3+ Belladonna D4+Aconitum<br />

D3+ Mercurius solubilis<br />

Hahnemanni D8+Hepar<br />

sulfuris D8 +Chamomilla D3+<br />

Symphytum D8 +Bellis<br />

perennis D2 +Echinacea<br />

angustifolia D2 +Echinacea<br />

purpurea D2 +Hypericum D2<br />

(Ethanolum35vol. . .)<br />

5500. Traumeel S Arnica D3 +Calendula Ø +<br />

Hamamelis Ø +Echinacea<br />

angustifolia Ø+Echinacea<br />

purpurea Ø + Chamomilla Ø +<br />

Symphytum D4 + Bellis<br />

perennis Ø + Hypericum D6+<br />

Millefolium Ø +Aconitum D1+<br />

Belladonna D1+ Mercurius<br />

solubilis Hahnemanni D6 +<br />

Hepar sulfuris D6<br />

5501. Traumeel S Arnica D2 +Calendula D2+<br />

Hamamelis D2 +Millefolium<br />

D3+ Belladonna D4 +<br />

Aconitum D3+Mercurius<br />

solubilis Hahnemanni D8+<br />

Hepar sulfuris D8 +<br />

Chamomilla D3+Symphytum<br />

D8 +Bellis perennis D2+<br />

Echinacea angustifolia D2 +<br />

Echinacea purpurea D2 +<br />

Hypericum D2<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

oral drops 5g+5g+5g+5g+25g+10g+10g+<br />

10g+8g+8g+2g+2g+2g+<br />

1g/100g 30ml;100ml<br />

ointment 1,5g+0,45g+0,45g+0,15g+<br />

0,15g+0,15g+0,1g+0,1g+<br />

0,09g+0,09g+0,05g+ 0,05g+<br />

0,04g+0,025g/ 100g 50g;100g<br />

tab. 15mg+15mg+15mg+ 15mg+<br />

75mg+30mg+ 30mg+30mg+<br />

24mg+ 24mg+6mg+6mg+<br />

6mg+ 3mg N50;N250<br />

5502. Travatan Travoprostum eye drops, sol. 40µg/ml 2,5ml N1; N3 Alcon-Couvreur<br />

5503. Travocort Isoconazoli nitras+<br />

Diflucortoloni valeras<br />

Heel<br />

Heel<br />

Heel<br />

cream 10mg+1mg/g 15g Schering<br />

5504. Travogen Isoconazoli nitras cream 10mg/g 20g Schering<br />

5505. Trental 400 Pentoxifyllinum prolongedrelease<br />

coated<br />

tab.<br />

400mg<br />

N100<br />

5506. Trexan Methotrexatum tab. 2,5mg N100 Orion<br />

5507. Trexan Methotrexatum sol. for inj. 25mg/ml<br />

20ml N1<br />

5508. Trexan Methotrexatum sol. for inj. 2,5mg/ml<br />

8ml vial N10<br />

5509. Triaklim Estradiolum; Estradiolum+<br />

Norehisteronum; Estradiolum<br />

5510. Triampur compositum Triamterenum+<br />

Hydrochlorothiazidum<br />

5511. Tribestan Tribestan, content of<br />

furastanile saponins<br />

film-coated tab. 2mg; 2mg+1mg; 1mg<br />

N28; N3×28<br />

Aventis Pharma<br />

Orion<br />

Orion<br />

tab. 25mg+ 12,5mg N50 AWD<br />

film-coated<br />

tablets<br />

5512. Trichopol Metronidazolum tab. 250mg<br />

N20<br />

5513. Tridin Glutamini monofluorophosphate<br />

×2NaCl (eq.<br />

to fluoridum)+Calcii gluconas<br />

monohydricum+ Calcii citras<br />

tetrahydricum<br />

chewable tab. 5mg+500mg+<br />

500mg<br />

Gedeon Richter<br />

250mg N60 Sopharma PLC<br />

Polpharma/<br />

Norfachema<br />

Rottapharm


EN<br />

366 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5514. Trifas 10 Torasemidum tab. 10mg N30; N50; N100 Berlin-Chemie<br />

(Menarini Group)<br />

5515. Trifas 10 ampoules Torasemidum sol. for inj 10mg/2ml N5 Berlin-Chemie<br />

(Menarini Group)<br />

5516. Trifas 20 ampoules Torasemidum sol. for inj. 20mg/4ml N5 Berlin-Chemie<br />

(Menarini Group)<br />

5517. Trifas 200 Torasemidum tab. 200mg N30;N50; N100 Berlin-Chemie<br />

(Menarini Group)<br />

5518. Trifas 200 infusion solution Torasemidum sol. for inf. 200mg/20ml amp. N5 Berlin-Chemie<br />

(Menarini Group)<br />

5519. Trifas Cor Torasemidum tab. 5mg N30; N50; N100 Berlin-Chemie<br />

(Menarini Group)<br />

5520. Trileptal 150 mg Oxcarbazepinum tab. 150mg N50 Novartis Pharma<br />

5521. Trileptal 300 mg Oxcarbazepinum tab. 300mg N50 Novatris Pharma<br />

5522. Trileptal 600 mg Oxcarbazepinum tab. 600mg N50 Novartis Pharma<br />

5523. Trileptal 6 % Oxcarbazepinum oral susp. 300mg/5ml 250ml Ciba-Geigy<br />

5524. Trimetazidine MR Servier Trimetazidinum modified release<br />

film-coated<br />

tablets<br />

5525. Trimetop 100 mg Trimethoprimum tab. 100mg<br />

N30; N100<br />

5526. Trimetop 160 mg Trimethoprimum tab. 160mg<br />

N10; N20<br />

5527. Trimetop duplo Sulfadiazinum+<br />

Trimethoprimum<br />

5528. Tri-Minulet Ethinylestradiolum+<br />

Gestodenum<br />

5529. Trimiron Desogestrelum+<br />

Ethinylestradiolum<br />

35mg N60 Les Laboratoires<br />

Servier Industrie /<br />

Anpharm<br />

tab. 500mg+ 160mg N10; N15;<br />

N20; N30; N100<br />

6 light brown<br />

tab.<br />

5 brown tab.,10<br />

white tab.<br />

5530. Trinitrolongas 1 mg Glyceroli trinitras tirpios biopolimerine˙s<br />

ple˙vele˙s<br />

5531. Trinitrolongas 2 mg Glyceroli trinitras tirpios biopolimerine˙s<br />

ple˙vele˙s<br />

5532. Trinordiol Levonorgestrelum+<br />

Ethinylestradiolum<br />

5533. Triovit Betacarotenum+<br />

Tocopherolum+ Acidum<br />

ascorbicum+ Selenium (Yeast<br />

complex)<br />

5534. Tripacel Component Pertussis (Pertussis<br />

toxoid+ Filamentous<br />

Hemagglutinin+ Fimbriae+<br />

Pertactin)+ Diphteria Toxoid+<br />

Tetanus Toxoid<br />

30µg+50µg, 40µg+70µg,<br />

30µg+100µg N1; N3<br />

coated tab. yellow tab.: 0,05mg+<br />

0,035mg; red tab.: 0,1mg +<br />

0,03mg; white tab.: 0,15mg+<br />

0,03mg N21;N3×21<br />

6 brown tab.;<br />

5 white tab.;<br />

10 yellow tab.<br />

1mg<br />

N50<br />

2mg<br />

N50<br />

50µg+30µg; 75µg+40µg;<br />

125µg+30µg N21; N63; N126<br />

caps. 10mg+ 40mg+ 100mg+ 50µg<br />

N30<br />

susp. for inj. (10µg+5µg+<br />

5µg+3µg)+ > or =30IU+ > or<br />

=40IU/0,5ml<br />

Vitabalans<br />

Vitabalans<br />

Vitabalans<br />

Wyeth-Pharma<br />

Organon<br />

Sanitas<br />

Sanitas<br />

Wyeth-Pharma<br />

KRKA<br />

Aventis Pasteur


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 367<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5535. Triphen Trihexyphenidylum tab. 2mg<br />

N100<br />

5536. Triple Antibiotic Ointment Bacitracin zinc+Neomycin+<br />

Polymixin<br />

5537. Triquilar Levonorgestrelum+<br />

Ethinylestradiolum<br />

5538. Tri-Regol Ethinylestradiolum+<br />

Levonorgestrelum<br />

5539. Tri-Regol Levonorgestrelum+<br />

Ethinylestradiolum<br />

5540. Trisequens Estradiolum; Estradiolum+<br />

Norethisteronum; Estradiolum<br />

5541. Trisiston Ethinylestradiolum+<br />

Levonorgestrelum;<br />

Ethinylestradiolum+<br />

Levonorgestrelum;<br />

Ethinylestradiolum+<br />

Levonorgestrelum<br />

5542. Tritanrix HB Diphtheria toxoid+<br />

Tetanus toxoid+<br />

Bordetella pertussis (killed)+<br />

Hepatitis B virus surface<br />

antigen<br />

Strength Manufacturer<br />

Sun<br />

ointment 400U+3,5mg+5U/g 14,2g Barre National/<br />

NASKA Pharm.<br />

sugar-coated<br />

tab.<br />

6 brown tab.:50µg+ 30µg; 5<br />

white tab.:75µg+ 40µg; 10<br />

ochre-colored tab.:125µg+<br />

30µg N21; N28 contains 7<br />

additional coated tab.without<br />

active ingredients<br />

film-coated tab. rausva tab.: 30µg+50µg; balta<br />

tab.: 40µg+75µg; geltona tab.:<br />

30µg+125µg<br />

tab. (yellow,<br />

apricotcoloured,white)<br />

film-coated tab.<br />

(12 blue, 10<br />

white, 6 red)<br />

sugar-coated<br />

tab.reddish<br />

brown, white,<br />

ochreous<br />

0,05mg+ 0,03mg; 0,075mg+<br />

0,04mg; 0,125mg+ 0,03mg<br />

N21;N3×21<br />

Schering<br />

Gedeon Richter<br />

Gedeon Richter<br />

2mg; 2mg+1mg; 1mg N28 Novo Nordisk<br />

0,03mg+<br />

0,05mg; 0,04mg+<br />

0,075mg; 0,03mg+<br />

0,125mg N21<br />

susp. for inj. 30IU+60IU+<br />

4IU+10µg/0,5ml<br />

Jenapharm<br />

SmithKline Beecham<br />

5543. Trittico retard Trazodonum tablets 75mg N30 A.C.R.A.F. S.p.A<br />

Angelini Francesco /<br />

CSC Pharmaceuticals<br />

Hendels<br />

5544. Trittico retard Trazodonum tablets 150mg N20;N60 A.C.R.A.F. S.p.A<br />

Angelini Francesco /<br />

CSC Pharmaceuticals<br />

Hendels<br />

5545. Trivorin Ribavirinum caps. 200 mg Sicor<br />

5546. Trivorin Ribavirinum caps. 400 mg Sicor<br />

5547. Trizivir Abacavirum+<br />

Lamivudinum+<br />

Zidovudinum<br />

5548. Trobicin Spectinomycinum powder and<br />

solvent for<br />

susp. for inj.<br />

5549. Trombinas Thrombinum topical dried<br />

subst.<br />

coated tab. 300mg+<br />

150mg+<br />

300mg N60<br />

2g/vial+3,2ml diluent (28,8mg<br />

benzyl alcohol/3,2ml amp.)N1<br />

Glaxo<br />

Pharmacia & Upjohn<br />

125-625 UA/amp. N10 Vilniaus kraujo<br />

centras<br />

5550. Troparin Certoparinum natricum sol. for inj. 3000IU anti-Xa(32mg) /0,3ml<br />

pre-filled syringe N5<br />

5551. Tropex Ear Drops Phenazonum ear drops, sol. 5% 10ml Rowa<br />

Biochemie<br />

5552. Tropicamidum 0,5 % Tropicamidum eye drops, sol. 5mg/ml 5ml;2×5ml Polfa Warsaw


EN<br />

368 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5553. Tropicamidum 1 % Tropicamidum eye drops, sol. 10mg/ml 5ml; 2×5ml Polfa Warsaw<br />

5554. Troxerutin Troxerutinum caps. 200mg N64 Pliva Krakow<br />

5555. Troxevasin Troxerutinum gel 20mg/g<br />

40g<br />

Balkanpharma-<br />

Troyan<br />

5556. Troxevasin 2% Troxerutinum gel 20mg/g 40g Balkanpharma-<br />

Razgrad<br />

5557. Troxevasin capsules<br />

300 mg<br />

Troxerutinum caps., hard 300mg N50 Balkanpharma-<br />

Razgrad<br />

5558. True Test Allergens diagnostic<br />

patch test<br />

system<br />

5559. Trusopt Dorzolamidum eye drops, sol. 20mg/ml<br />

5ml<br />

N1 Pharmacia & Upjohn<br />

MSD-Chibret<br />

5560. Truxal Chlorprothixenum film-coated tab. 100mg N50; N100 Lundbeck<br />

5561. Truxal Chlorprothixenum film-coated tab. 25mg N50; N100 Lundbeck<br />

5562. Truxal Chlorprothixenum film-coated tab. 50mg N50; N100 Lundbeck<br />

5563. Tuberculin PPD RT23 SSI Tuberculin PPD purified batch<br />

RT23<br />

sol. for inj. 0,4µg/ml 5ml;10×1,5ml Statens Serum<br />

Institut<br />

5564. Tubocin Rifampicinum caps., hard 300mg N100 Balkanpharma-<br />

Razgrad<br />

5565. Tubocin Rifampicinum caps., hard 150mg N100 Balkanpharma-<br />

Razgrad<br />

5566. Tulzˇi˛ varantis vaistazˇoliu˛<br />

mišinys<br />

5567. Tulzˇi˛ varantis vaistazˇoliu˛<br />

mišinys ‘Cholo-2’<br />

5568. Tulzˇi˛ varantis vaistazˇoliu˛<br />

mišinys Nr.2<br />

5569. Tulzˇies apykaita˛ reguliuojantis<br />

vaistazˇoliu˛ mišinys<br />

5570. Tulzˇies apykaita˛ reguliuojantis<br />

vaistazˇoliu˛ mišinys ‘Cholo-1’<br />

Flor. Helichrysi arenarii+Fol.<br />

Menyanthidis trifoliate+Fol.<br />

Menthae piperitae+ Fruct.<br />

Coriandri<br />

Helichrysi flos +Millefolii herba<br />

+Menthae piperitae folium +<br />

Coriandri fructus<br />

Flores Helichrysi arenarii+<br />

Herba Millefolii+ Folia<br />

Menthae piperitae+Fructus<br />

Coriandri<br />

Fol. Menyanthidis trifoliatae+<br />

Fol. Menthae piperitae+ Herb.<br />

Polygoni avicularis<br />

Menyanthidis folium+ Menthae<br />

piperitae folium +Polygoni<br />

avicularis herba<br />

5571. Tums Calcii carbonas+ Magnesii<br />

carbonas<br />

herbal tea 36,3g+27,3g+18,2g+18,2g<br />

100g; 50g; 50g (2g×25); 50g<br />

(1g×50)<br />

herbal tea 40g+20g+<br />

20g+20g/<br />

100g 37,5g (1,5g×25)<br />

herbal tea 40g+20g+20g+20g 100g; 50g;<br />

50g (2g×25); 50g (1g×50)<br />

herbal tea 33,4g+33,3g+33,3g 100g;<br />

50g; 50g (2g×25)<br />

herbal tea 33,4g+33,3g+33,3g/100g<br />

37,5g (1,5g×25)<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Acorus Calamus<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Acorus Calamus<br />

tab. 600mg+ 125mg N15 SmithKline Beecham<br />

5572. Tuopu˛ pumpurai Gemm. Populi herbal tea 100g; 50g 50g (2g×25) Švenčioniu˛<br />

vaistazˇole˙s<br />

5573. Turinal Allylestrenolum tab. 5mg<br />

N20<br />

5574. Tussimont Hustensaft Senegae extractum fluidum+<br />

Aurantii amari extractum<br />

fluidum+ Thymi extractum<br />

fluidum<br />

Gedeon Richter<br />

oral sol. 3g+5g+10g/ 100g 120g;180g Pharmonta


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 369<br />

No. Commercial name General name<br />

5575. Tussimont Hustentropfen Ammonii chloridum+ Thymi<br />

extractum fluidum+ Plantaginis<br />

lanceolata extractum fluidum<br />

Pharmaceutical<br />

form<br />

oral drops 3g+48,475g+48,475g/ 100g<br />

50g<br />

Strength Manufacturer<br />

Pharmonta<br />

5576. Tussin Guaifenesinum syrup 100mg/5ml 118ml Perrigo<br />

5577. Tussipect Ephedrini hydrochloridum+<br />

Glycyrrhizae rad.extr.sicc.+<br />

Glycyrrhizae rad.pulv.+<br />

Saponinum+Thymolum+<br />

Natrii benzoas<br />

5578. Twinrix Adult Hepatitis A+Hepatitis B<br />

vaccine<br />

5579. Twinrix Junior Hepatitis A+ Hepatitis B<br />

vaccine<br />

5580. Tylenol Cold Medication Paracetamolum+<br />

Pseudoephedrinum+<br />

Dextromethorphanum+<br />

Chlorphenaminum<br />

5581. Tylenol Cold Non-Drowsiness<br />

Formula<br />

5582. Tylenol nuo peršalimo vaikams<br />

(vyšniu˛ skonio)<br />

Paracetamolum+<br />

Pseudoephedrinum+<br />

Dextromethorphanum<br />

Paracetamolum+Dextromethorphane<br />

hydrobromidum+<br />

Pseudoephedrinum+<br />

Chlorphenaminum<br />

5583. Tymsal Extr.Thymi fl.+ Tinct. Salviae<br />

(Ethanolum 34-39%)<br />

5584. Typherix 25 µg/0,5 ml Vi polysaccharide of<br />

Salmonella typhi<br />

5585. Typhim Vi Salmonella typhi (Ty2 strain)<br />

polysaccharides<br />

5586. Tyrosur Ointment Tyrothricinum+ Cetylpyridinii<br />

chloridum<br />

film-coated tab. 15mg+60mg+72mg+ 12mg+<br />

0,002mg+16,7mg N20<br />

Herbapol<br />

susp. for inj. >720 ELISA units+20µg/ml N1 SmithKline Beecham<br />

susp. for inj. >360 ELISA units+10µg/<br />

0,5ml N1<br />

film-coated<br />

caplets<br />

325mg+30mg+15mg+<br />

2mg N30<br />

tab. 325mg+30mg+15mg<br />

N20; N12; N24<br />

chewable tab. 80mg+2,5mg+7,5mg+ 0,5mg<br />

N24<br />

SmithKline Beecham<br />

McNeil/<br />

Grindex<br />

McNeil<br />

McNeil / Grindeks<br />

aerosol 70%+30% 30g Herbapol Cracow<br />

sol. for inj. 25µg/0,5ml pre-filled syringe<br />

N1; N10<br />

sol. for inj. 0,025mg/0,5ml pre-filled<br />

syringe N1<br />

5587. Tyzine Tetryzolinum nasal drops, sol. 1mg/ml<br />

10ml<br />

SmithKline Beecham<br />

Pasteur Merieux<br />

oint-ment 1mg+ 0,5mg/g 5g; 20g Engelhard<br />

5588. Tyzine Tetryzolinum nasal drops, sol. 0,5mg/ml 10ml Mack<br />

5589. Ubistesin Articainum+ Epinephrinum sol. for inj. 40mg+ 0,005mg/ml 1,7ml<br />

cartridges N50<br />

5590. Ubistesin forte Articainum+ Epinephrinum sol. for inj. 40mg+ 0,01mg/ml 1,7ml<br />

cartridges N50<br />

5591. UFT Tegafurum+Uracilum caps., hard 100mg+224mg N21; N28;<br />

N35; N42; N56; N84; N112;<br />

N140; N168<br />

Mack<br />

3M ESPE<br />

3M ESPE<br />

5592. Ugniazˇole˙s zˇole˙ Herb. Chelidonii 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

5593. Ulcosan Ranitidinum coated tab. 150mg N30 IVAX-CR<br />

5594. Ulfamid Famotidinum film-coated tab. 20mg<br />

N20<br />

Taiho<br />

KRKA


EN<br />

370 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5595. Ulfamid Famotidinum film-coated tab. 40mg<br />

N10<br />

5596. Ultiva Remifentanilum powder for sol.<br />

for inj.<br />

1mg/vial<br />

N5<br />

Strength Manufacturer<br />

5597. Ultop Omeprazolum caps. 20mg N14 KRKA<br />

5598. Ultracain D-S Articainum+Epinephrinum sol. for inj. 40mg+0,006mg/ml 1,7ml<br />

cartridges N100<br />

5599. Ultracain D-S Articainum+Epinephrinum sol. for inj. 40mg+0,006mg/ml 2ml vials<br />

N100<br />

5600. Ultracain D-S forte Articainum+Epinephrinum sol. for inj. 40mg+0,012mg/ml 2ml vials<br />

N100<br />

5601. Ultracain D-S forte Articainum+Epinephrinum sol. for inj. 40mg+0,012mg/ml 1,7ml<br />

cartridges N100<br />

5602. Ultraproct Fluocortoloni pivalas+<br />

Fluocortoloni caproas +<br />

Cinchocaini hydrochloridum<br />

5603. Ultraproct Fluocortoloni pivalas+<br />

Fluocortoloni caproas+<br />

Cinchocaini hydrochloridum<br />

KRKA<br />

Glaxo Wellcome<br />

Aventis Pharma<br />

Aventis Pharma<br />

Aventis Pharma<br />

Aventis Pharma<br />

ointment 0,92mg+ 0,95mg+ 5mg/g 10g Schering<br />

supp. 0,61mg+ 0,63mg+ 1mg N10 Schering /<br />

Boehringer<br />

Ingelheim<br />

5604. Ultravist — 240 Iopromidum sol. for inj./inf. 499mg/ml 10ml; 50ml N10 Schering<br />

5605. Ultravist — 300 Iopromidum sol. for inj./inf. 623,4mg/ml 10ml; 20ml;<br />

50ml;100ml<br />

5606. Ultravist — 370 Iopromidum sol. for inj./inf. 768,86mg/ml bottles 50ml;<br />

100ml<br />

5607. Umckalor Extr. Pelargonium sodoides<br />

spirituose (1:10)<br />

drops 8g/10g<br />

20ml<br />

5608. Unasyn Sultamicillinum film-coated tab. 375mg<br />

N12<br />

5609. Unasyn Sultamicillinum powder for oral<br />

susp.<br />

5610. Unasyn 1 500 Sulbactamum+<br />

Ampicillinum<br />

powder for sol.<br />

for inj.<br />

5611. Unasyn 3 g Sulbactamum+ Ampicillinum powder for sol.<br />

for inj.<br />

5612. Unasyn 750 Sulbactamum+<br />

Ampicillinum<br />

5613. Undevit Retinolum acetatum+<br />

Thiaminum+Riboflavinum+<br />

Pyridoxinum+<br />

Cyanocobalaminum+<br />

Acidum ascorbicum +<br />

Tocopherolum+<br />

Nicitinamidum+ Acidum<br />

folicum +Rutinum+Calcii<br />

pantothenas<br />

powder for sol.<br />

for inj.<br />

Schering<br />

Schering<br />

ISO-Arzneimittel<br />

Pfizer<br />

250mg/5ml 30ml (1,5g) Pfizer<br />

500mg+<br />

1 000mg/vial N1<br />

Pfizer Italiana<br />

1 000mg+2 000mg/vial N1 Pfizer Italiana<br />

250mg+500mg/vial N1 Pfizer Italiana<br />

drag. 1,135mg+2mg+2mg+3mg+<br />

2µg+75mg+<br />

10mg+20mg+<br />

0,07mg+10mg+3mg N50<br />

5614. Undevitum Multivitaminai drag. N50; N60; N100 Liuks<br />

5615. Unguentum ‘Cortomycetin’ Hydrocortisonum+<br />

Chloramphenicolum<br />

Marbiofarm<br />

ointment 5mg+2mg/g 15g Nizˇfarm


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 371<br />

No. Commercial name General name<br />

5616. Unguentum ‘Hioxysonum’ Hydrocortisonum+<br />

Oxytetracyclinum<br />

Pharmaceutical<br />

form<br />

5617. Unguentum Calendulae Calendula officinalis ø ointment 200mg/g<br />

30g; 50g<br />

5618. Unguentum Nystatini<br />

100 000 UI in 1,0<br />

Strength Manufacturer<br />

ointment 10mg+ 30mg/g 10g Nizˇfarm<br />

Aconitum<br />

Nystatinum ointment 100000UI/g 15g Nizˇfarm<br />

5619. Unguentum Synaflani Fluocinoloni acetonidum ointment 0,25mg/g 15g Nizˇfarm<br />

5620. Unicap M Retinolum+ Colecalciferolum+<br />

Thiaminum+Riboflavinum+<br />

Acidum ascorbicum +<br />

Nicotinamidum+<br />

Pyridoxinum+Calcii<br />

pantothenas+<br />

Cyanocobalaminum+ Ferrum<br />

(Ferri fumaras)+Iodum+<br />

Cuprum+ Manganum+<br />

Magnesium+ Kalium +Calcium<br />

5621. Unicap M Multivitamins and minerals film-coated<br />

tablets<br />

5622. Unicap Plus Iron Acidum ascorbicum+<br />

Thiaminum+ Riboflavinum+<br />

Pyridoxinum+ Acidum<br />

folicum+ Calcii pantothenas +<br />

Nicotinamidum+ Ferrosi<br />

fumaras+ Cholecalciferolum+<br />

Cyanocobalaminum+<br />

Tocopherolum+ Retinolum+<br />

Calcii hydrogenphosphas<br />

5623. Unicap Sr. Acidum ascorbicum+<br />

Thiaminum+ Riboflavinum+<br />

Pyridoxinum+ Acidum<br />

folicum+ Calcii pantothenas+<br />

Nicotinamidum+ Ferrosi<br />

fumaras+ Betacarotenum+<br />

Cholecalciferolum+<br />

Cyanocobalaminum+<br />

Tocopheroli acetas+Retinoli<br />

acetas+Zinci oxidum+Cupri<br />

sulfas+Calcii<br />

hydrogenphosphas<br />

5624. Unicap T Retinolum+ Colecalciferolum+<br />

Thiaminum+Riboflavinum+<br />

Acidum ascorbicum+<br />

Nicotinamidum+<br />

Pyridoxinum+Calcii<br />

pantothenas+<br />

Cyanocobalaminum+Ferrum<br />

(Ferri fumaras)+Iodum+<br />

Cuprum+Manganum+<br />

Magnesium+ Kalium+Calcium<br />

5625. Unicap T Multivitamins and minerals film-coated<br />

tablets<br />

film-coated tab. 5000 UI+ 500 UI +2,5mg+<br />

2,5mg+50mg+ 20mg+ 0,5mg+<br />

5mg+ 2µg+10mg+ 0,15mg+<br />

1mg+ 1mg+6mg+ 5mg+35mg<br />

N30<br />

N30 Ferrosan<br />

tab. 66mg+ 1,601mg+ 1,785mg+<br />

2,673mg+ 0,5333mg+<br />

14,68mg+ 21mg+ 68,45mg+<br />

540UI+ 7,5µg+ 31,5UI+<br />

8 500UI+ 430mg N30<br />

tab. 69mg+ 1,32mg+ 1,47mg+<br />

2,94mg+ 0,556mg+<br />

13,59mg+ 17,12mg+<br />

30,42mg+ 330UI+ 270UI+<br />

3,3µg+ 17,55mg+ 8 160UI+<br />

18,67mg+ 8,251mg+ 430mg+<br />

11,142mg N30<br />

film-coated tab. 5000 UI+ 500 UI +10mg +<br />

10mg+ 300mg+ 100mg+<br />

2mg+ 20mg+4µg+ 10mg+<br />

0,15mg+1mg+1mg+6mg+<br />

5mg+50mg N30<br />

5626. Uniclophen Unimed Pharma Diclofenacum natricum eye drops 1mg/ml<br />

10ml<br />

5627. Uniflu Plus with Gregovite ‘C’<br />

(Vitamin ‘C’ 300 mg) Tablets<br />

Coffeinum+ Codeinum+<br />

Diphenhydraminum+<br />

Paracetamolum+<br />

Phenylephrinum; Acidum<br />

ascorbicum<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

N30 Ferrosan A/S<br />

tab. 30mg+10mg+15mg+<br />

500mg+10mg; +300mg<br />

6 Uniflu+ 6 Gregovit‘C’ N12;<br />

12 Uniflu+ 12 Gregovit ‘C’<br />

N24<br />

Unimed Pharma<br />

Unigreg


EN<br />

372 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

5628. Uniflu with Gregovite ‘C’<br />

(Vitamin ‘C’ 300 mg) Tablets<br />

Coffeinum+<br />

Diphenhydraminum+<br />

Paracetamolum+<br />

Phenylephrinum; Acidum<br />

ascorbicum<br />

Pharmaceutical<br />

form<br />

tab. 30mg+15mg+ 500mg+10mg;<br />

+300mg<br />

6 Uniflu+ 6 Gregovit‘C’ N12;<br />

12 Uniflu+ 12 Gregovit ‘C’<br />

N24<br />

5629. Uniloc Atenololum tab. 50mg<br />

N30<br />

5630. Uniloc Atenololum tab. 100mg<br />

N30<br />

Strength Manufacturer<br />

5631. Unipres 10 Nitrendipinum tab. 10mg N20 KRKA<br />

5632. Unipres 20 Nitrendipinum tab. 20mg N20 KRKA<br />

5633. Uniroid-HC Hydrocortisonum+<br />

Cinchocainum<br />

5634. Uniroid-HC Hydrocortisonum+<br />

Cinchocainum<br />

5635. Uprima 2 mg Apomorphini hydrochloridum sublingual tab. 2mg<br />

N2<br />

5636. Uprima 3 mg Apomorphini hydrochloridum sublingual tab. 3mg<br />

N2<br />

5637. Upsamox Amoxicillinum powder for oral<br />

susp.<br />

5638. Upsamox Amoxicillinum powder for oral<br />

susp.<br />

Unigreg<br />

Nycomed DAK/<br />

SEFA<br />

Nycomed DAK/<br />

SEFA<br />

supp. 5mg+5mg N12 Unigreg<br />

ointment 5mg+5mg/g 15g Unigreg<br />

Abbott<br />

Abbott<br />

250mg/5ml 60ml Bristol-Myers Squibb<br />

125mg/5ml 60ml Bristol-Myers Squibb<br />

5639. Upsamox Amoxicillinum caps. 500mg N12 Bristol-Myers Squibb<br />

5640. Upsamox Amoxicillinum caps. 250mg N12 Bristol-Myers Squibb<br />

5641. Upsarin Upsa su vitaminu C Acidum acetylsalicylicum+<br />

Acidum ascorbicum<br />

efferv. tablet 330mg+<br />

200mg<br />

N10<br />

5642. Upsavit Calcium Calcium (carbonate) efferv. tab. 500mg<br />

N20<br />

5643. Upsavit Tonic for Children Calcii fructoheptonas+Magnesii<br />

aspartas+Kalii aspartas+<br />

Acidum ascorbicum+<br />

Pyridoxinum+ Nicotinamidum<br />

powder for oral<br />

sol. in single<br />

dose sachets<br />

5644. Upsavit Vitaminas C 1000mg Acidum ascorbicum efferv. tablet 1000mg<br />

N10<br />

300mg+ 100mg+ 47,6mg+<br />

250mg+ 12,5mg+<br />

25mg/sachet N18<br />

UPSA<br />

Pharmavit<br />

5645. Uractone Spironolactonum tab. 100mg SPA-Societa Prodotti<br />

Antibiotici<br />

5646. Uractonum Spironolactonum tab. 25mg N20 Medochemie<br />

5647. Uregyt Acidum etacrynicum tab. 50mg N20 Egis<br />

5648. Urgo Cor Acidum salicylicum emplastrum +<br />

ointment<br />

5649. Urilan (Urilanas) Extr.Cucurbitae+Extr. Populi+<br />

Extr. Rhois+Extr. Equiseti+<br />

Extr.Hyperici+Sem.Cucurbitae+<br />

Silicium+Manganum+Selenium<br />

5650. Urispas 200 Flavoxati hydrochloridum sugar coated<br />

tab.<br />

UPSA<br />

UPSA<br />

40g/100g N12 Urgo<br />

caps., soft 375mg+ 150mg+ 125mg+<br />

75mg+75mg+25mg+ 25mg+<br />

2,1mg+10µg N40<br />

200mg<br />

N30<br />

Arco-Chemie<br />

Recordati


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 373<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5651. Urobacid Norfloxacinum film-coated tab. 400mg<br />

N10<br />

5652. Urodanum Piperazinum hexahydricum+<br />

Hexamethylentetraminum+<br />

Natrii benzoas +Lithii benzoas<br />

+Natrii hydrogenophosphas<br />

anhydrycum+ Natrii<br />

hydrogenocarbonas+ Acidum<br />

tartaricum<br />

+Saccharum<br />

5653. Urografin 60 % Natrii amidotrizoas+<br />

Meglumini amidotrizoas<br />

5654. Urografin 76 % Natrii amidotrizoas+<br />

Meglumini amidotrizoas<br />

5655. Urografin 76% Natrii amidotrizoas+<br />

Meglumini amidotrizoas<br />

gran. 2,5g+8g+2,5g+2g+10g+<br />

37,5g+35,5g+<br />

1,9g 100g<br />

Strength Manufacturer<br />

Biochemie<br />

Medpro<br />

sol. for inj./inf. 80mg+ 520mg/ml 20ml N10 Schering<br />

sol. for inj./inf. 100mg+ 660mg/ml 20ml N10 Schering<br />

solution for<br />

injection or<br />

infusion<br />

5656. Uromitexan Mesnum film-coated tab. 400mg<br />

N100; N200<br />

0,1g+0,66g 100ml N10 Schering<br />

Temmler Pharma/<br />

Asta Medica<br />

5657. Uromitexan Mesnum sol. for inj. 200mg/2ml amp. Asta Medica<br />

5658. Uromitexan Mesnum film-coated tab. 600mg<br />

N100; N200<br />

5659. Uromitexan 400 mg Mesnum solution for<br />

injection<br />

5660. Urosept Petroselini rad., Phaseoli<br />

peric.,Betulae<br />

fol.extr.comp.spiss.+<br />

Chamomillae anth.extr.sicc.+<br />

Vitis ideaae fol.extr.sicc.+<br />

Phaseoli pericarpium pulv. +<br />

Acidum citricum+ Kalii citras+<br />

Natrii citras<br />

Temmler Pharma/<br />

Asta Medica<br />

400mg/4ml ampoules N15 Asta Medica<br />

film-coated tab. 86,2mg+8mg+26mg+ 78mg+<br />

6mg+19mg+16mg<br />

N60<br />

5661. Urotractin Acidum pipemidicum caps. 400mg<br />

N10<br />

5662. Ursofalk kapsule˙s Acidum ursodeoxycholicum caps. 250mg N50,N100 Falk<br />

5663. Ursosan Acidum ursodeoxycholicum caps. 250mg<br />

N50<br />

5664. Urtiron Urticae radicis extractum<br />

siccum (5:1)+ beta-<br />

Sitosterolum<br />

Herbapol<br />

caps. 300mg+ 10mg N40 KRKA<br />

5665. Uvamin Retard Nitrofurantoinum caps., hard 100mg N20; N30 Mepha<br />

5666. Uzara Extr. sicc. rad. Uzarae sol. 50mg/ml 30ml;100ml Stada<br />

5667. Uzara Extr. sicc. rad. Uzarae coated tab. 50mg N20; N50 Stada<br />

5668. Vaccinum encephalitidis<br />

ixodicae<br />

Inaktyvuotu˛ erkinio encefalito<br />

virusu˛ (Sofiin paderme˙)<br />

virionai<br />

susp. for inj. (0,5 ±0,15)µg /0,5ml amp.<br />

vakccine+ solv. amp. N5<br />

Thissen for Eurodrug<br />

Laboratories<br />

Pro. Med. CS Praha<br />

Čumakovo<br />

Poliomielito ir<br />

virusiniu˛ encefalitu˛<br />

institutas


EN<br />

374 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

5669. Vaccinum gripposum<br />

chromatographicum<br />

inactivatum liquidum<br />

A/Moscow/10/99 (H3N2)-like<br />

strain (A/Panama/2007/99<br />

RESVIR-17reass.)+A/New<br />

Caledonia/20/99 (H1N1)-like<br />

strain (A/New Caledonia/20/99<br />

IVR-116 reass.)+B/Hong<br />

Kong/330/2001-like strain<br />

(B/Hong Kong/330/2001)<br />

Pharmaceutical<br />

form<br />

5670. Vagifem Estradiolum vaginal tab. 25µg<br />

N15<br />

5671. Vagilac Lactobacillus acidophilus+<br />

Lactobacillus bifidus+ Jogurto<br />

kultūra (Streptococcus<br />

thermophilus+ Lactobacillus<br />

delbrueckii subsp. bulgaricus)<br />

sol. for inj. 10±1µg haemaglutinin+<br />

10±1µg haemaglutinin+<br />

13±1µg haemaglutinin/0,5ml<br />

1ml amp., 2 doses N10<br />

vaginal caps. 18mg+10mg+40mg<br />

N10<br />

5672. Vagisan Acidum lacticum+ Natrii lactas vaginal supp. 167mg+ 100mg<br />

N7<br />

Strength Manufacturer<br />

Pastero institutas<br />

Novo Nordisk<br />

Pharmascience<br />

5673. Vagotyl /Vagothyl Policresulenum sol. 36g/100g 50g Polfa Pabianice<br />

5674. Vaistazˇoliu˛ arbata ‘Ajeru˛<br />

šakniastiebiai’<br />

5675. Vaistazˇoliu˛ arbata ‘Anyzˇiu˛<br />

vaisiai’<br />

5676. Vaistazˇoliu˛ arbata ‘Apyniu˛<br />

spurgai’<br />

5677. Vaistazˇoliu˛ arbata ‘Asiūkliu˛<br />

zˇole˙’<br />

5678. Vaistazˇoliu˛ arbata ‘Aviečiu˛<br />

lapai’<br />

5679. Vaistazˇoliu˛ arbata ‘A˛zˇuolu˛<br />

zˇieve˙’<br />

5680. Vaistazˇoliu˛ arbata ‘A˛zˇuolu˛<br />

zˇieve˙’ smulkinta<br />

Wolff<br />

Calami rhizomata herbal tea 50g Acorus Calamus<br />

Anisi fructus herbal tea 50g Acorus Calamus<br />

Strobuli lupuli herbal tea 20g; 25g (1g×25) Acorus Calamus<br />

Equisetum arvense herba herbal tea 30g; 25g (1g×25) Acorus Calamus<br />

Rubi idaei folium herbal tea 40g Acorus Calamus<br />

Quercus cortex herbal tea 50g Acorus Calamus<br />

Quercus cortex herbal tea 100g; 50g; 50g (2g×25); 37,5g<br />

(1,5g×25); 25g (1g×25)<br />

Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

5681. Vaistazˇoliu˛ arbata ‘Berzˇu˛ lapai’ Betulae folium herbal tea 40g Acorus Calamus<br />

UAB<br />

5682. Vaistazˇoliu˛ arbata ‘Berzˇu˛<br />

pumpurai’<br />

5683. Vaistazˇoliu˛ arbata ‘Brukniu˛<br />

lapai’<br />

5684. Vaistazˇoliu˛ arbata ‘Čiobreliu˛<br />

zˇole˙’<br />

5685. Vaistazˇoliu˛ arbata ‘Čiobreliu˛<br />

zˇole˙’ smulkinta<br />

5686. Vaistazˇoliu˛ arbata ‘Debesylu˛<br />

šaknys’<br />

5687. Vaistazˇoliu˛ arbata ‘Dilge˙liu˛<br />

lapai’<br />

5688. Vaistazˇoliu˛ arbata ‘Erške˙čiu˛<br />

vaisiai’<br />

Betuale gemmae herbal tea 50g Acorus Calamus<br />

Vitisideae folium herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

Thymi herba herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

Serpylli herba herbal tea 100g; 50g; 50g (2g×25); 37,5g<br />

(1,5g×25); 25g (1g×25)<br />

Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

Inulae radix herbal tea 50g Acorus Calamus<br />

Urticae folium herbal tea 30g; 25g (1g×25) Acorus Calamus<br />

Rosae pseudo-fructus herbal tea 100g Acorus Calamus


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 375<br />

No. Commercial name General name<br />

5689. Vaistazˇoliu˛ arbata ‘Eukaliptu˛<br />

lapai’<br />

5690. Vaistazˇoliu˛ arbata ‘Gudobeliu˛<br />

lapai ir zˇiedai’<br />

5691. Vaistazˇoliu˛ arbata ‘Islandine˙s<br />

kerpenos’<br />

5692. Vaistazˇoliu˛ arbata ‘Jonazˇoliu˛<br />

zˇole˙’<br />

5693. Vaistazˇoliu˛ arbata ‘Kadagiu˛<br />

vaisiai’<br />

5694. Vaistazˇoliu˛ arbata ‘Karčiu˛ju˛<br />

kiečiu˛ zˇole˙’<br />

5695. Vaistazˇoliu˛ arbata ‘Kiaulpieniu˛<br />

šaknys’<br />

5696. Vaistazˇoliu˛ arbata ‘Kinrozˇiu˛<br />

zˇiedai’<br />

5697. Vaistazˇoliu˛ arbata ‘Kmynu˛<br />

vaisiai’<br />

5698. Vaistazˇoliu˛ arbata ‘Krapu˛<br />

vaisiai’<br />

5699. Vaistazˇoliu˛ arbata ‘Kraujazˇoliu˛<br />

zˇole˙’<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

Eucalypti folium herbal tea 50g Acorus Calamus<br />

Crataegi folium cum flore herbal tea 25g; 37,5g (1,5g×25) Acorus Calamus<br />

Cetraria islandica herbal tea 40g Acorus Calamus<br />

Hyperici herba herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

Juniperi pseudo-fructus herbal tea 50g Acorus Calamus<br />

Absinthii herba herbal tea 40g Acorus Calamus<br />

Taraxaci radix herbal tea 50g Acorus Calamus<br />

Hibisci sabdariffae flos herbal tea 30g (1,5g×20) Acorus Calamus<br />

Carvi fructus herbal tea 100g Acorus Calamus<br />

Anethi graveolens fructus herbal tea 50g Acorus Calamus<br />

Millefolii herba herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

5700. Vaistazˇoliu˛ arbata ‘Liepu˛ zˇiedai’ Tiliae flos herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

5701. Vaistazˇoliu˛ arbata ‘Linu˛ se˙klos’ Lini semen herbal tea 200g Acorus Calamus<br />

5702. Vaistazˇoliu˛ arbata ‘Medetku˛<br />

zˇiedai’<br />

5703. Vaistazˇoliu˛ arbata ‘Medetku˛<br />

zˇiedai’<br />

Calendulae flos herbal tea 50g; 30g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

Calendulae flores herbal tea 30g; 30g (1,2g×25) Acorus Calamus<br />

5704. Vaistazˇoliu˛ arbata ‘Melisu˛ lapai’ Melissae folium herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

5705. Vaistazˇoliu˛ arbata ‘Meškauogiu˛<br />

lapai’<br />

5706. Vaistazˇoliu˛ arbata ‘Našlaičiu˛<br />

zˇole˙ suzˇiedais’<br />

5707. Vaistazˇoliu˛ arbata ‘Paprastu˛ju˛<br />

kukurūzu˛ liemene˙liai su<br />

purkomis’<br />

5708. Vaistazˇoliu˛ arbata ‘Pipirme˙čiu˛<br />

lapai’<br />

5709. Vaistazˇoliu˛ arbata ‘Plačialapiu˛<br />

gysločiu˛ lapai’<br />

5710. Vaistazˇoliu˛ arbata ‘Ramune˙liu˛<br />

zˇiedai’<br />

5711. Vaistazˇoliu˛ arbata ‘Ramune˙liu˛<br />

zˇiedai’ smulkinta<br />

Uvae ursi folium herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

Violae herba cum flores herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

Zeae maydis cum stigmatis herbal tea 30g Acorus Calamus<br />

Menthae piperitae folium herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

Plantaginis majoris folium herbal tea 30g Acorus Calamus<br />

Chamomillae flores herbal tea 25g; 14g<br />

(0,7g×20)<br />

Matricariae flos herbal tea 100g; 50g; 50g (2g×25); 37,5g<br />

(1,5g×25); 25g (1g×25)<br />

Acorus Calamus<br />

Karvelio terapijosfitoterapijos<br />

i˛mone˙


EN<br />

376 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

5712. Vaistazˇoliu˛ arbata ‘Rūgčiu˛<br />

takazˇoliu˛ zˇole˙’<br />

5713. Vaistazˇoliu˛ arbata ‘Saldzˇiu˛ju˛<br />

pankoliu˛ vaisiai’<br />

5714. Vaistazˇoliu˛ arbata ‘Šaltekšniu˛<br />

zˇieve˙’<br />

5715. Vaistazˇoliu˛ arbata ‘Šeivamedzˇiu˛<br />

zˇiedai’<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

Polygoni avicularis herba herbal tea 40g; 37,5g (1,5g×25) Acorus Calamus<br />

Foeniculum vulgare var. dulcis<br />

fructus<br />

herbal tea 100g Acorus Calamus<br />

Frangulae cortex herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

Sambuci flos herbal tea 40g Acorus Calamus<br />

5716. Vaistazˇoliu˛ arbata ‘Senos lapai’ Sennae folium herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

5717. Vaistazˇoliu˛ arbata ‘Sidabrazˇoliu˛<br />

šakniastiebiai’<br />

5718. Vaistazˇoliu˛ arbata ‘Smiltyniniu˛<br />

šlamučiu˛ zˇiedai’<br />

5719. Vaistazˇoliu˛ arbata ‘Taukiu˛<br />

šaknys’<br />

5720. Vaistazˇoliu˛ arbata ‘Trikerčiu˛<br />

zˇvaginiu˛ zˇole˙’<br />

5721. Vaistazˇoliu˛ arbata ‘Ugniazˇoliu˛<br />

zˇole˙’<br />

5722. Vaistazˇoliu˛ arbata ‘Vaistiniu˛<br />

šalaviju˛ lapai’<br />

5723. Vaistazˇoliu˛ arbata ‘Valerijonu˛<br />

šaknys’<br />

5724. Vaistazˇoliu˛ arbata vartojama<br />

klimakteriniu periodu<br />

‘Harmonija’<br />

5725. Vaistazˇoliu˛ arbata vartojama<br />

menstruaciju˛ metu ‘Mano<br />

dienos’<br />

5726. Vaistazˇoliu˛ arbata vartojama<br />

peršalus ‘Gripolis-1’<br />

5727. Vaistazˇoliu˛ arbata vartojama<br />

peršalus ‘Gripolis-2’<br />

5728. Vaistazˇoliu˛ mišinys nuo<br />

cukralige˙s<br />

5729. Vaistazˇoliu˛ mišinys nuo<br />

hemorojaus<br />

5730. Vaistazˇoliu˛ mišinys nuo<br />

nespecifinio viduriavimo<br />

Tormentillae rhizoma herbal tea 50g Acorus Calamus<br />

Helichrysi arenarii flos herbal tea 20g; 20g (0,8g×25) Acorus Calamus<br />

Symphyti radix herbal tea 50g Acorus Calamus<br />

Bursae pastoris herba herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

Chelidonium majus herba herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

Salviae officinalis folium herbal tea 50g Acorus Calamus<br />

Valerianae radix herbal tea 50g; 50g (2g×25) Acorus Calamus<br />

Fol. Menthae pip.+<br />

Fol. Melissae+<br />

Strob.Lupuli+Rad. Valerianae+<br />

Flor. Crataegi+Herb. Millefolii+<br />

Fol. Sennae+Herb. Centaurii+<br />

Flor. Chamomillae<br />

Herb. Millefolii + Fol. Melissae<br />

+ Strob.Lupuli<br />

Flor.Chamomillae+Flor. Tiliae+<br />

Fol. Melissae+Fruct. Cynosbati<br />

c. seminae<br />

Flor. Tiliae+Fol. Melissae seu<br />

Thymi citriodori+Fruct.<br />

Cynosbati c. seminae+Fol.<br />

Fragariae+Fol. Rubi fruticosi+<br />

Flor Sambuci+Flor. Hibisci+<br />

Fruct. Foeniculi<br />

Herb. Artemisiae vulgaris+<br />

Valvae fruct. Phaseoli vulgaris+<br />

Corm. Vaccinii Myrtilli<br />

Folia Sennae+Herba Millefolii+<br />

Cortex Frangulae+Fructus<br />

Coriandri+Rhizomata cum<br />

radicibus Glycyrrhizae<br />

Fruct.Alni+Cort.<br />

Quercus+Flor.<br />

Chamomillae+<br />

Rhiz. Tormentillae+<br />

Herb. Alchemillae<br />

herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

herbal tea 50g; 37,5g (1,5g×25) Acorus Calamus<br />

herbal tea 0,25g+0,25g+0,375g + 0,5g<br />

N25 po 1,5g; 50g<br />

herbal tea 0,14g+0,21g+‰,29g +0,14g+<br />

0,21g+0,28g+ 0,21g +0,14g<br />

N25 po 1,5g; 50g<br />

Acorus Calamus<br />

Acorus Calamus<br />

herbal tea 50g+50g+ 200g Švenčioniu˛<br />

vaistazˇole˙s<br />

herbal tea 20g+20g+20g+20g+20g 100g;<br />

50g;48g(2g×24); 16,8g(0,7g×<br />

24); 24g(1g×24); 36g(1,5g×24)<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

herbal tea 50g+40g+30g+20g+20g 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 377<br />

No. Commercial name General name<br />

5731. Vaistazˇoliu˛ mišinys nuo plauku˛<br />

slinkimo<br />

5732. Vaistazˇoliu˛ mišinys nuo<br />

šlapimo taku˛ uzˇdegimo sergant<br />

akmenlige<br />

5733. Vaistazˇoliu˛ mišinys nuo<br />

viduriu˛ pūtimo<br />

5734. Vaistazˇoliu˛ mišinys sergant<br />

prostatitu<br />

5735. Vaistazˇoliu˛ mišinys sergant<br />

skrandzˇio ir dvylikapiršte˙s<br />

zˇarnos opalige<br />

5736. Vaistazˇoliu˛ mišinys: Dilge˙liu˛<br />

lapai 30 g, Šermukšniu˛ vaisiai<br />

70 g<br />

5737. Vaistazˇoliu˛ vitamininis mišinys<br />

Nr.1<br />

Fol.Urticae+Rhiz.<br />

Calami+Strob.<br />

Humuli lupuli+<br />

Cort.Quercus<br />

Fol. Urvae ursi+<br />

Herb.Polygoni avicularis+Herb.<br />

Millefolii+Fol. Menthae pip.+<br />

Flor.Calendulae<br />

Fol. Menthae piperitae+ Fruct.<br />

Foeniculi+ Rhizomata cum<br />

radicibus Valerianae<br />

Fol.Urticae+ Herb.Hyperici+<br />

Herb.Bidentis+ Herb.Callunae+<br />

Flor.Calendulae<br />

Sem.Lini+ Herb.Millefolii+<br />

Herb.Leonuri+ Flor.Calendulae<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

herbal tea 30g+30g+20g+20g /100g Švenčioniu˛<br />

vaistazˇole˙s<br />

herbal tea 30g+30g+20g+10g+10g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

herbal tea 33,33g+ 33,33g+ 33,33g<br />

100g; 50g; 50g (2g×25)<br />

herbal tea 40g+20g+ 10g+10g+ 10g<br />

100g<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

herbal tea 40g+20g+ 10g+15g 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

Urticae folia+Sorbi fructus herbal tea 30g+70g/ 100g 100g; 50g;<br />

50g (2g×25); 25g (1g×25)<br />

Rosae fructus+Ribes nigri<br />

fructus<br />

herbal tea 50g+50g 100g; 50g; 50g<br />

(2g×25)<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

5738. Vaistine˙s melisos zˇole˙ Herba Melissae officinalis herbal tea 50g; 50g(2g×25) Švenčioniu˛<br />

vaistazˇole˙s<br />

5739. Valdispert Extr. rad.Valerianae drag. 45mg N50;N100 Solvay<br />

Pharmaceuticals<br />

5740. Valdispert 125 Extr. rad. Valerianae siccum dragee 125mg<br />

N100<br />

5741. Valeradix, Anti-Stress Tablets Valerianae radix+Mellisae<br />

folium+Leonuri herba+Lupuli<br />

strob.<br />

tab. 170mg+ 50mg+ 50mg+ 50mg<br />

N20;N60<br />

5742. Valeriana Extr. Valerianae siccum film-coated tab. 30mg<br />

N20;100<br />

5743. Valerianaheel Valeriana officinalis Ø+<br />

Humulus lupulus Ø +<br />

Crataegus Ø +<br />

Hypericum perfora- tum D1+<br />

Melissa officinalis Ø +<br />

Chamomilla recutita Ø +Avena<br />

sativa Ø +Acidum picrinicum<br />

D5+ Kalium bromatum D1+<br />

Ammonium bromatum D1+<br />

Natrium bromatum D1;<br />

Ethanolum 60% v/v<br />

5744. Valerijono šakniastiebiai su<br />

šaknimis<br />

drops 65g+5g+5g+<br />

5g+3g+2g+2g+ 10g+1g+1g+<br />

1g/100g 30ml; 100ml<br />

Solvay<br />

Pharmaceuticals<br />

Labofarm<br />

Medica<br />

Rhiz. cum rad. Valerianae herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

5745. Valerijono tablete˙s Extr. Valerianae tab. 0,02 g N10 Liuks<br />

5746. Valerijono tinktūra Rhiz. cum rad. Valerianae +<br />

Ethanolum 70%<br />

5747. Valerijono tinktūra Rhizoma cum radicibus<br />

Valerianae<br />

tinct. 200g +ad 1l<br />

30ml; 50ml<br />

tinct. 200g (Ethanolum 70% ad 1l)<br />

30ml<br />

Heel<br />

Sanitas<br />

Vilniaus f.f.


EN<br />

378 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

5748. Valerijonu˛ šakniastiebiai su<br />

šaknimis<br />

Valerianae rhizomata cum<br />

radicibus<br />

5749. Valerijonu˛ tinktūra Rhizoma cum radicibus<br />

Valerianae subtilissimus<br />

5750. Validol Mentholum+<br />

Methylisovalerianicum<br />

5751. Validolio tablete˙s Mentholum+<br />

Methylisovalerianicum<br />

5752. Validolis su gliukoze (Mentholum+<br />

Methylisovalerianicum)+<br />

Glucosum<br />

5753. Valocordin Phenobarbitalum+ Ethylium<br />

bromisovalerianicum<br />

(Ethanolum 55%)<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

herbal tea 50g R.Vaitkaus<br />

individuali i˛mone˙<br />

liq. 200g (Ethanolum 70% ad<br />

1000ml) 30ml; 50ml<br />

Bakteriniai<br />

preparatai<br />

tab. 60mg N20 Farmak<br />

tab. 0,06 N10; N20 Liuks<br />

tab. 60mg+ 188mg N10 Leksredstva<br />

oral drops, sol. 18mg+ 18mg/ml 20ml; 50ml Krewel Meuselbach<br />

5754. Valofyt Neo compos. species, tea bags 1,5g every tea bag, N20 Leros Co.<br />

5755. Valtrex Valaciclovirum film-coated tab. 500mg<br />

N10<br />

5756. Valused Passiflorae tinct.+ Humuli<br />

lupul tinct. +Valerianae<br />

intractum<br />

5757. Valytas tuberkulinas<br />

standartiniame praskiedime<br />

Alergenum tuberculosum<br />

depuratum fluidum<br />

5758. Vamin 14 Alaninum+ Argininum+<br />

Acidum asparticum+<br />

Cysteinum+ Acidum<br />

glutamicum+ Glycinum+<br />

Histidinum+ Isoleucinum+<br />

Leucinum+ Lysinum+<br />

Methioninum+<br />

Phenylalaninum+ Prolinum+<br />

Serinum+ Threoninum+<br />

Tryptophanum+ Tyrosinum+<br />

Valinum+ Natrii acetas+ Kalii<br />

chloridum+ Calcii gluconas<br />

5759. Vamin 14 be elektrolitu˛ Alaninum+Argininum+Acidum<br />

asparticum+Cysteinum (+<br />

Cystinum)+ Acidum<br />

glutamicum+Glycinum+<br />

Histidinum+Isoleucinum+<br />

Leucinum+ Lysinum+<br />

Methioninum+<br />

Phenylalaninum+ Prolinum+<br />

Serinum+ Threoninum+<br />

Tryptophanum+ Tyrosinum+<br />

Valinum<br />

5760. Vamin 18 be elektrolitu˛ Alaninum+ Argininum+<br />

Acidum asparticum+<br />

Cysteinum+ Acidum<br />

glutamicum+ Glycinum+<br />

Histidinum+ Isoleucinum+<br />

Leucinum+ Lysinum+<br />

Methioninum+<br />

Phenylalaninum+<br />

Prolinum+ Serinum+<br />

Threoninum+ Tryptophanum+<br />

Tyrosinum+ Valinum<br />

extr. 40,5g+ 32,4g+ 4,05g/90g 35g;<br />

90g<br />

Glaxo Wellcome<br />

Hasco-Lek<br />

sol. 2VV/0,1 ml amp. 3ml N5 Bakteriniai<br />

preparatai<br />

sol.for inf. 12g+8,4g+ 2,5g+ 420mg+<br />

4,2g+5,9g+ 5,1g+4,2g+ 5,9g+<br />

6,8g+ 4,2g+5,9g+ 5,1g+3,4g+<br />

4,2g+1,4g+ 170mg+ 5,5g+<br />

13,6g+3,73g+ 2,24g+ 1,97g/<br />

1000ml 500ml; 1000ml<br />

sol.for inf. 12g+8,4g+2,5g+420mg+<br />

4,2g+5,9g+5,1g+4,2g+ 5,9g+<br />

6,8g+4,2g+5,9g+<br />

5,1g+3,4g+4,2g+ 1,4g+<br />

170mg+5,5g/ 1000ml 500ml<br />

sol.for inf. 16g+11,3g+3,4g+ 560mg+<br />

5,6g+7,9g+ 6,8g+5,6g+ 7,9g+<br />

9g+ 5,6g+7,9g+ 6,8g+4,5g+<br />

5,6g+1,9g+ 230mg+<br />

7,3g/1000ml 500ml; 1000ml<br />

Federa Limoges<br />

Federa Limoges<br />

Federa Limoges


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 379<br />

No. Commercial name General name<br />

5761. Vamin N Alaninum+ Argininum+<br />

Acidum asparticum+<br />

Cysteinum (+Cystinum)+<br />

Acidum glutamicum+<br />

Glycinum+ Histidinum+<br />

Isoleucinum+ Leucinum+<br />

Lysinum+ Methioninum+<br />

Phenylalaninum+Prolinum+<br />

Serinum+ Threoninum+<br />

Tryptophanum+ Tyrosinum+<br />

Valinum+Kalii chloridum+<br />

Calcii chloridum<br />

5762. Vamin su gliukoze Alaninum+ Argininum+<br />

Acidum asparticum+<br />

Cysteinum (+Cystinum)+<br />

Acidum glutamicum+<br />

Glycinum+ Histidinum+<br />

Isoleucinum+ Leucinum+<br />

Lysinum+ Methioninum+<br />

Phenylalaninum+Prolinum+<br />

Serinum+ Threoninum+<br />

Tryptophanum+ Tyrosinum+<br />

Valinum+ Glucosum + Kalii<br />

chloridum+<br />

5763. Vaminolact Alaninum+ Argininum+<br />

Acidum asparticum+<br />

Cysteinum (+Cystinum)+<br />

Acidum glutamicum+<br />

Glycinum+ Histidinum+<br />

Isoleucinum+ Leucinum+<br />

Lysinum+ Methioninum+<br />

Phenylalaninum+Prolinum+<br />

Serinum+ Taurinum+<br />

Threoninum+ Tryptophanum+<br />

Tyrosinum+ Valinum<br />

Pharmaceutical<br />

form<br />

5764. Vancocin CP Vancomycinum powder for sol.<br />

for inj.<br />

5765. Vancomycin Teva Vancomycinum powder for sol.<br />

for inj.<br />

5766. Vandenilio peroksido<br />

3 % tirpalas<br />

5767. Vandenilio peroksido 3 %<br />

tirpalas<br />

5768. Vandenilio peroksido 3 %<br />

tirpalas BP<br />

5769. VapoRub Camphora+Terebinthinae<br />

oleum+Levomentholum+<br />

Eucalypti aetheroleum<br />

Strength Manufacturer<br />

sol.for inf. 3g+3,3g+ 4,1g+1,4g+ 9g+<br />

2,1g+ 2,4g+3,9g+ 5,3g+3,9g+<br />

1,9g+5,5g+ 8,1g+7,5g+ 3g+<br />

1g+ 500mg+ 4,3g+ 375mg+<br />

368mg+ 370mg+2g+ 840mg/<br />

1000ml 500ml<br />

sol.for inf. 3g+3,3g+4,1g+1,4g+9g+<br />

2,1g+2,4g+ 3,9g+5,3g+ 3,9g+<br />

1,9g+ 5,5g+8,1g+ 7,5g+3g+<br />

1g+500mg+ 4,3g+100g+<br />

375mg+ 368mg+ 370mg+2g+<br />

840mg/ 1000ml 100ml;<br />

500ml; 1000ml<br />

sol.for inf. 6,3g+4,1g+ 4,1g+1g+ 7,1g+<br />

2,1g+ 2,1g+3,1g+ 7g+5,6g+<br />

1,3g+2,7g+ 5,6g+3,8g+<br />

300mg+ 3,6g+1,4g+ 500mg+<br />

3,6g/1000ml 100ml;500ml<br />

Federa Limoges<br />

Federa Limoges/<br />

Fresenius Kabi<br />

Federa Limoges/<br />

Fresenius Kabi<br />

500mg N1 Eli Lilly & Co./Lilly<br />

Pharma Fertigung<br />

und Distribution<br />

GmbH&<br />

CoKG<br />

500mg N1 Teva<br />

Hydrogenii peroxidum sol. 7,5-11g/ 100ml 40ml Bakteriniai<br />

preparatai<br />

laboratorija Galen<br />

Hydrogenii peroxidum sol. 7,5-11g/ 100ml; 40ml;<br />

80ml<br />

Vilniaus f.f.<br />

Hydrogenii peroxidum sol. 30mg/ml 25ml;40ml; 80ml Bakteriniai<br />

preparatai<br />

ointment 5g+5g+2,75g+1,5g/100g 40g;<br />

50g; 90g; 100g<br />

5770. Varfarins-Grindeks 1 mg Warfarinum natricum tab. 1mg<br />

N100<br />

5771. Varfarins-Grindeks 3 mg Warfarinum natricum tab. 3mg<br />

N100<br />

5772. Varfarins-Grindeks 5 mg Warfarinum natricum tab. 5mg<br />

N100<br />

Procter & Gamble<br />

Grindeks<br />

Grindeks<br />

Grindeks


EN<br />

380 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

5773. Varicella Vaccine Live<br />

Attenuated ‘Biken’<br />

Attenuated live varicella-zoster<br />

virus (Oka strain)<br />

5774. Varilrix Live attenuated varicella virus<br />

vaccine, OKA strain<br />

5775. Varitect Human varicella zoster<br />

immunoglobulin<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

susp. for inj. 1000PFU/ 0,5ml vial Kanonji Institute<br />

powder and<br />

solvent for sol.<br />

for inj.<br />

2000pfu/0,5ml SmithKline Beecham<br />

sol. for inf./inj. 25IU/ml 5ml,20ml amp.; 50ml<br />

bottle<br />

5776. Varnale˙šos šaknys Rad. Bardanae herbal tea 50g Acorus Calamus<br />

5777. Vasaprostan Alprostadilum powder for sol.<br />

for inf.<br />

5778. Vasilip Simvastatinum film-coated tab. 10mg<br />

N28<br />

5779. Vasilip Simvastatinum film-coated tab. 20mg<br />

N28<br />

5780. Vasilip Simvastatinum film-coated tab. 40mg<br />

N28<br />

5781. Vasobral Dihydroergocryptini mesylas+<br />

Coffeinum<br />

Biotest<br />

20µg/amp. N10 Schwarz Pharma<br />

KRKA<br />

KRKA<br />

KRKA<br />

oral sol. 50mg+ 500mg/50ml Laboratoires Jaques<br />

Logeais<br />

5782. Vasocardin 50 Metoprololum tab. 50mg N20; N50 Slovakofarma<br />

5783. Vasonit retard 600mg Pentoxifyllinum film-coated<br />

tablets<br />

5784. Vaxigrip (2002/2003 strains) A/Moscow/10/99 (H3N2)-like<br />

strain (A/Panama/2007/99<br />

(RESVIR-17)+ A/New<br />

Caledonia/20/99 (H1N1)-like<br />

strain (A/New Caledonia/20/99<br />

(IVR-116)+ B/Hong<br />

Kong/330/2001-like strain<br />

(B/Shon-gdong/7/97)<br />

5785. Vaxigrip pediatric use<br />

(2002/2003 strains)<br />

A/Moskow/10/99 (H3N2)-like<br />

strain (A/Panama/2007/99<br />

(Resvir-17)+A/New<br />

Caledonia/20/99 (H1N1)-like<br />

strain (A/New Caledonia/20/99<br />

(IVR-116)+B/Hong<br />

Kong/330/2001-like strain<br />

(B/Shang-dong /7/97)<br />

600mg N20 Lannacher Heilmittel<br />

susp. for inj. 15µg haemagglutinin+ 15µg<br />

haemagglutinin+ 15µg<br />

haemagglutinin/ dose 0,5ml<br />

pre-filled syringe, single dose<br />

N1<br />

susp. for inj. 7,5µg haemagglutinin+ 7,5µg<br />

haemagglutinin+ 7,5µg<br />

haemagglutinin/ dose 0,25ml<br />

pre-filled syringe, single dose<br />

N1<br />

Aventis Pasteur<br />

Aventis Pasteur<br />

5786. Vazelinas Vaselinum ointment 25g KMA vaistine˙<br />

5787. Vazogel Extr.Hippocastani sem.spir.fl.+<br />

Extr. Meliloti herb.spir.fl.;<br />

Ethanol 96%<br />

gel 350mg+ 20mg+ 160mg/g 40g KRKA<br />

5788. Vectavir Penciclovirum cream 23mg/2g SmithKline Beecham<br />

5789. Venal (Venalas) Extr.rad.Rusci Aculeati sicc.+<br />

Extr.Aesculi Hippocastani sicc.<br />

+Rutosidum+ Ac.ascorbicum+<br />

Thiamini nitras<br />

5790. Vendal Morphini hydrochloridum sustainedreleasefilmcoated<br />

tab.<br />

caps. 150mg+ 60mg+ 100mg+<br />

90mg+2mg N40<br />

Arco-Chemie<br />

100mg N10; N30 Lannacher


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 381<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5791. Vendal Morphini hydrochloridum sustainedreleasefilmcoated<br />

tab.<br />

5792. Vendal Morphini hydrochloridum sustainedreleasefilmcoated<br />

tab.<br />

5793. Vendal Morphini hydrochloridum sustai-nedreleasefilmcoated<br />

tab.<br />

5794. Vendal Morphini hydrochloridum sustainedreleasefilmcoated<br />

tab.<br />

5795. Venengel-ratiopharm Heparinum natricum+<br />

Hippocastani tinctura+Arnicae<br />

tinctura<br />

5796. Venoplant Extr.Aesculus hippocastani<br />

siccum (4,5-5,5:1)<br />

5797. Venoruton 1000mg<br />

putojančios tablete˙s<br />

O-(beta-hydroxyethyl)rutosides<br />

Strength Manufacturer<br />

200mg N10; N30 Lannacher<br />

60mg N10; N30 Lannacher<br />

30mg N10; N30 Lannacher<br />

10mg N10; N30 Lannacher<br />

gel 10000UI+ 20g+ 10g/100g<br />

50g<br />

sustainedrelease<br />

tab.<br />

effervescent<br />

tablets<br />

263,2mg<br />

N20; N50; N100<br />

Merckle<br />

Dr.Willmar Schwabe<br />

1000mg N15 Swiss Co Services<br />

5798. Venoruton Emulgel Heparinum natricum gel 0,343g (60000IU)/ 100g 40g;<br />

100g<br />

5799. Venoruton forte O-(beta-Hydroxyethyl)rutosides<br />

5800. Venoruton gel O-(beta-hydroxyethyl)rutosides<br />

Novartis<br />

tab. 500mg N30 Novartis Consumer<br />

gel 20mg/g 40g Novartis Consumer<br />

5801. Venter Sucralfatum gran. 1g/2g (viename maišelyje) N50 KRKA<br />

5802. Venter Sucralfatum tab. 1g N50 KRKA<br />

5803. Ventolin Salbutamolum tab. 4mg<br />

N100<br />

5804. Ventolin Salbutamolum sol. for inj. 0,5mg/ml<br />

N5<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

5805. Ventolin Diskus Salbutamolum inhal. 200µg/dose N1 Glaxo Wellcome<br />

5806. Ventolin Inhaler Salbutamolum metered dose<br />

inhaler<br />

(suspension)<br />

100µg/<br />

actuation<br />

200 doses N1<br />

Glaxo Wellcome<br />

Poznan<br />

5807. Ventolin nebules Salbutamolum nebules 2,5mg/2,5ml N20 Glaxo Wellcome<br />

5808. Ventolin nebules Salbutamolum nebules 5mg/2,5ml N20 Glaxo Wellcome<br />

5809. Ventolin syrup Salbutamolum syrup (sugarfree)<br />

2mg/5ml 150ml Glaxo<br />

Pharmaceuticals<br />

5810. Vepesid Etoposidum sol. for inj. 100mg/5ml vial N1 Bristol-Myers Squibb<br />

5811. Vepesid Etoposidum caps. 100mg<br />

N10<br />

5812. Vepesid Etoposidum caps. 50mg<br />

N20<br />

5813. Veral Diclofenacum enteric-coated<br />

tab.<br />

50mg<br />

N50<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Slovakofarma


EN<br />

382 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5814. Veral Diclofenacum enteric-coated<br />

tab.<br />

25mg<br />

N30<br />

Strength Manufacturer<br />

Slovakofarma<br />

5815. Veral Diclofenacum supp. 100mg N10 Slovakofarma<br />

5816. Veral 100 retard Diclofenacum tablets 100mg N30 Slovakofarma<br />

5817. Veral 75 retard Diclofenacum tablet 75mg N20 Slovakofarma<br />

5818. Veral gel Diclofenacum gel 1g/100g<br />

55g<br />

5819. Verapamil Alpharma Tablets<br />

40 mg<br />

Slovakofarma<br />

Verapamilum tab. 40mg N50 Alpharma<br />

5820. Verapamilio 40 tablete˙s Verapamilum tab. 40 mg N20; N30; N100 Liuks<br />

5821. Verapamilio 80 tablete˙s Verapamilum tab. 80 mg N20; N30; N100 Liuks<br />

5822. Verapamil-ratiopharm Verapamili hydrochloridum film-coated tab. 40mg N20;N50 Merckle<br />

5823. Verapamil-ratiopharm Verapamili hydrochloridum film-coated tab. 80mg N50 Merckle<br />

5824. Vercef Cefaclorum caps. 250mg N3 Ranbaxy<br />

5825. Vermox Mebendazolum tab. 100mg<br />

N6<br />

Gedeon Richter<br />

5826. Vermox Mebendazolum tab. 100mg N6 Xian-Janssen/<br />

Janssen-Cilag<br />

5827. Vermox Mebendazolum tab. 100 mg N6; N10 Liuks<br />

5828. Verogalid ER 240 mg Verapamilum extended-release<br />

tab.<br />

5829. Verorab (single dose) Rabies virus (WISTAR Rabies<br />

PM/WI 38 1503-3M strain)<br />

powder and<br />

solvent for<br />

susp.for inj.<br />

5830. Verospiron Spironolactonum tab. 25mg<br />

N20<br />

5831. Verospiron Spironolactonum caps. 50mg<br />

N30<br />

5832. Verospiron Spironolactonum caps. 100mg<br />

N30<br />

5833. Vertigoheel Conium maculatum D3 +<br />

Ambra grisea D6 +Petroleum<br />

rectificatum D8+Anamirta<br />

cocculus D4 (Ethanolum<br />

35 vol.-%)<br />

5834. Vertigoheel Anamirta cocculus D4 +<br />

Conium maculatum ex herba<br />

recentis D3 +Ambra grisea D6<br />

+Petroleum rectificatum D8<br />

5835. Vfend 200mg Voriconazolum film-coated<br />

tablets<br />

5836. Vfend 200mg Voriconazolum powder for<br />

solution for<br />

infusion<br />

5837. Vfend 50mg Voriconazolum film-coated<br />

tablets<br />

240mg N30; N100 IVAX-CR<br />

>2,5IU/vial+0,5ml syringe of<br />

diluent N1;N5<br />

oral drops 10g+10g+10g+70g/100g<br />

30ml;100ml<br />

tab. 210mg+30mg+30mg+ 30mg<br />

N50;N250<br />

200mg N10;N14; N20;N28;<br />

N30;N100<br />

Pasteur Merieux<br />

Gedeon Richter<br />

Gedeon Richter<br />

Gedeon Richter<br />

Heel<br />

Heel<br />

Heinrich Mack<br />

Nachf. GmbH & Co.<br />

200mg/vial N1 Pfizer S.A.<br />

50mg N10;N14; N20;N28;<br />

N30;N100<br />

Heinrich Mack<br />

Nachf. GmbH & Co.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 383<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5838. Viagra Sildenafil (citrate) coated tab. 100mg N1; N4 Pfizer<br />

5839. Viagra Sildenafil (citrate) coated tab. 50mg N1; N4 Pfizer<br />

5840. Viagra Sildenafil (citrate) coated tab. 25mg N1; N4 Pfizer<br />

5841. Vibramycin Doxycyclinum caps. 100mg N10 Pfizer<br />

5842. Vibramycin Doxycyclinum caps. 100mg N5 KRKA<br />

5843. Vibrocil Dimetindeni maleas+<br />

Phenylephrinum<br />

5844. Vibrocil Dimetindeni maleas+<br />

Phenylephrinum<br />

5845. Viburcol Chamomilla D1+ Belladonna<br />

D2 +Dulcamara D4+Plantago<br />

major D3 +Pulsatilla D2 +<br />

Calcium carbonicum<br />

Hahnemanni D8<br />

nasal drops, sol. 0,025%+ 0,25% 15ml Novartis<br />

nasal spray, sol. 0,025%+ 0,25% 10ml Novartis<br />

supp. 1,1mg+1,1mg+1,1mg+<br />

1,1mg+2,2mg+4,4mg N12;<br />

N60; N120<br />

5846. Vicasolum Phytomenadionum sol. 1% 1ml N10 Liuks<br />

5847. Videne Alcoholic Tincture Povidonum iodinatum<br />

(Polyvidonum)<br />

5848. Videne Antiseptic Solution Povidonum iodinatum<br />

(Polyvidonum)<br />

5849. Videne Surgical Scrub Povidonum iodinatum<br />

(Polyvidonum)<br />

5850. Videx Didanosinum tab. 25mg<br />

N60<br />

5851. Videx Didanosinum tab. 50mg<br />

N60<br />

5852. Videx Didanosinum tab. 100mg<br />

N60<br />

5853. Videx Didanosinum tab. 150mg<br />

N60<br />

5854. Viduriavima˛ stabdanti<br />

vaistazˇoliu˛ arbata<br />

Rhiz.Tormentilae +<br />

Fol.Menthae +<br />

Flor.Chamomillae<br />

5855. Viduriu˛ lašai Tinct.Valerianae+ Tinct.<br />

Absinthii+ Tinct. Menthae pip.<br />

+ Tinct. Bella-donnae<br />

5856. Viduriu˛ lašai BP Tinctura Valerianae+ Tinctura<br />

Absinthii+ Tinctura Menthae<br />

piperitae+ Tinctura<br />

Belladonnae<br />

5857. Vidurius laisvinantis vaistazˇoliu˛<br />

mišinys Nr. 1<br />

5858. Vidurius laisvinantis vaistazˇoliu˛<br />

mišinys Nr. 2<br />

Frangulae cort.+<br />

Menthae piperitae fol.+Carvi<br />

fruct.<br />

Sennae fol.+<br />

Frangulae cort. +<br />

Menthae piperitae fol.+<br />

Chamomillae flos<br />

Heel<br />

tincture 10g/100g 500ml; 5l Adams Healthcare<br />

sol. 10g/100g 250ml; 500ml; 5l Adams Healthcare<br />

sol. 7,5g/100g 500ml; 5l Adams Healthcare<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

herbal tea 2g+1,5g+1g N25 po 1,5g; 50g Acorus Calamus<br />

drops 40ml+30ml+ 20ml+10ml<br />

(Ethanolum >=65%) 25ml<br />

oral drops,sol. 0,4ml+ 0,3ml+ 0,2ml+<br />

0,1ml/ml 25ml;50ml<br />

herbal tea 40g+30g+30g<br />

50g; 50g (2g× 25);<br />

44g (2g × 22)<br />

herbal tea 20g+20g+30g+ 30g 50g;<br />

50g (2g×25);<br />

44g (2g×22)<br />

Vilniaus f.f.<br />

Bakteriniai<br />

preparatai<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Švenčioniu˛<br />

vaistazˇole˙s


EN<br />

384 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

5859. Vidurius laisvinantis vaistazˇoliu˛<br />

mišinys Nr.1<br />

5860. Vidurius laisvinantis vaistazˇoliu˛<br />

mišinys Nr.2<br />

Sennae folium+ Hibisci flores+<br />

Rosae pseudofructus+ Sambuci<br />

fructus+ Mali cortex<br />

Cortex Frangulae+ Hibisci<br />

flores+ Rosae pseudofructus+<br />

Sambusci nigrae fructus+ Mali<br />

cortex<br />

Pharmaceutical<br />

form<br />

herbal tea 0,9g+0,6g+0,3g+0,6g+<br />

0,6g/3g maišeliuose N20<br />

herbal tea 0,9g+0,6g+0,3g+0,6g+<br />

0,6g/3g maišeliuose N20<br />

Strength Manufacturer<br />

5861. Vigantol oil Colecalciferolum oral sol. 0,5mg (20000IU)/ml 10ml Merck<br />

5862. Vilonet Ethinylestradiolum+<br />

Desogestrelum<br />

coated tab. 0,03mg+ 0,15mg<br />

N21; N63<br />

Manus Humana<br />

Manus Humana<br />

Leipziger<br />

Arzneimittelwerk<br />

5863. Vinblastin Liquid-Richter Vinblastinum sol. for inj. i.v. 10mg/5ml N1; N5; N25 Gedeon Richter<br />

5864. Vinblastin Liquid-Richter Vinblastinum sol. for inj. i.v. 5mg/5ml N1; N5; N25 Gedeon Richter<br />

5865. Vinblastine Vinblastinum lyophil. pulv. as<br />

tab.<br />

5866. Vincristin Liquid-Richter<br />

injectable solution<br />

Vincristinum sol. for inj. 1mg/ml<br />

N5; N25<br />

10mg N10 Abic<br />

5867. Vincristine Vincristinum sol. for inj. 1mg/ml 1ml Abic<br />

Gedeon Richter<br />

5868. Vinpocetine Covex 5 mg Vinpocetinum tab. 5mg N25; N50 Boehringer<br />

Mannheim<br />

5869. Vinpocetine-Rivo 5 Vinpocetinum tab. 5mg<br />

N50; N100<br />

5870. Vinpocetino 5 mg tablete˙s Vinpocetinum tab. 5 mg N30; N50 Liuks<br />

5871. Vinpocetino 10 mg tablete˙s Vinpocetinum tab. 10 mg N30; N50 Liuks<br />

Rivopharm<br />

5872. Vinposan Vinpocetinum tab. 5mg Sanitas<br />

5873. Viosept Tripelennaminum+<br />

Clioquinolum+<br />

Domipheni bromidum<br />

ointment 20mg+20mg+<br />

0,5mg/g 15g<br />

5874. Vioxx Rofecoxibum film-coated tab. 12,5mg<br />

N14; N28; N7<br />

5875. Vioxx Rofecoxibum film-coated tab. 25mg N14; N28; N7 MSD<br />

5876. Vioxx Rofecoxibum oral susp. 12,5mg/5ml 150ml MSD<br />

5877. Vioxx Rofecoxibum oral susp. 25mg/5ml 150ml MSD<br />

5878. Vioxx forte Rofecoxibum tab. 50mg N2; N5 MSD<br />

5879. Viprosal B Venenum Viperae berus sicc. +<br />

Acidum Salicylicum+<br />

Camphora+Oleum<br />

Terebinthinae<br />

5880. Viracept Nelfinavir mesylate powder for oral<br />

sol.<br />

ointment 0,05U+10mg+30mg+-30mg/g<br />

50g<br />

5881. Viracept Nelfinavir mesylate tab. 250mg<br />

N180; N270<br />

Jelfa<br />

MSD<br />

Tallinna<br />

Farmaatsiatehase<br />

50mg/g 144g vial Mova Pharmaceutical<br />

Mova Pharmaceutical<br />

5882. Viramune Nevirapinum tab. 200mg N60; N100 Boehringer<br />

Ingelheim


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 385<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5883. Viramune Nevirapinum oral susp. 50mg/5ml 240ml Roxane Laboratories<br />

for Boehringer<br />

Ingelheim Pharma<br />

5884. Virolex Aciclovirum eye ointment 30mg/g 4,5g KRKA<br />

5885. Virolex Aciclovirum tab. 200mg N20 KRKA<br />

5886. Virolex Aciclovirum powder for inf. 250mg/vial N5 KRKA<br />

5887. Virolex Aciclovirum cream 50mg/g 5g KRKA<br />

5888. Virškinima˛ gerinantis<br />

vaistazˇoliu˛ mišinys Nr. 1<br />

5889. Virškinima˛ reguliuojanti<br />

vaistazˇoliu˛ arbata<br />

Menthae piperitae fol.+<br />

Foeniculi fruct. +Melissae fol.+<br />

Millefolii herb.<br />

Fruct. Carvi+<br />

Herb. Gentaurii+<br />

Rad. Gentiannae+<br />

Herb. Thymi<br />

herbal tea 25g+25g+25g+25g 50g; 50g<br />

(2g× 25);<br />

44g (2g×22)<br />

herbal tea 0,8g+0,5g+0,25g+0,375g N25<br />

po 1,5g; 50g<br />

Švenčioniu˛<br />

vaistazˇole˙s<br />

Acorus Calamus<br />

5890. Viru-Merz Serol Tromantadinum gel 10mg/g 2g; 5g Merz+Co<br />

5891. Virusan 0,05 % Xylometazolinum nasal drops,<br />

solution<br />

5892. Virusan 0,1 % Xylometazolinum nasal drops,<br />

solution<br />

0,5mg/ml 10ml Norfachema<br />

1mg/ml 10ml Norfachema<br />

5893. Virzˇio zˇole˙ Herb. Callunae herbal tea 100g Karvelio terapijosfitoterapijos<br />

i˛mone˙<br />

5894. Visadron Phenylephrinum eye drops, sol. 1,25mg/ml 10ml Boehringer<br />

Ingelheim<br />

5895. Visine Tetryzolinum eye drops, sol. 0,5mg/ml 15ml Pfizer<br />

5896. Visine AC Tetryzolinum+ Zinci sulfas eye drops 0,5mg+ 2,5mg/ml 15ml Pfizer<br />

5897. Visionace Retinolum+ Betacarotenum+<br />

Colecalciferolum+ Acidum<br />

ascorbicum+ Thiaminum+<br />

Riboflavinum+Pyridoxinum+<br />

Cyanocobalaminum+ Acidum<br />

folicum+ Nicotinamidum+<br />

Acidum pantothenicum+<br />

Tocopherolum+<br />

Phytomenadionum+<br />

Ferrum(II)+Magnesium+<br />

Zincum+ Iodum+ Manganum+<br />

Cuprum+ Chromium<br />

5898. Visipaque 150mg I/ml Iodixanolum solution for<br />

injection<br />

5899. Visipaque 270mg I/ml Iodixanolum solution for<br />

injection<br />

5900. Visipaque injection 320mg<br />

I/ml<br />

Iodixanolum solution for<br />

injection<br />

caps., hard 1000IU+ 3mg+2,5µg+<br />

150mg+ 7,5mg+ 5mg+<br />

4,5mg+ 4,5µg+ 250µg+ 9mg+<br />

10mg+60mg+ 45µg+3mg+<br />

50mg+ 7,5mg+ 100µg+ 2mg+<br />

1mg+ 50µg+ 100µg+ 60mg+<br />

15mg N30<br />

150mg/ml 50ml N10; 200ml<br />

N6<br />

270mg/ml 20ml N10; 50ml<br />

N10; 100ml N10; 200ml N6<br />

320mg/ml 20ml N10; 50ml<br />

N10; 100ml N10; 200ml N6<br />

5901. Visken Pindololum tab. 5mg N30 Egis<br />

5902. Višnevskio linimentas Pix liquida Betulae+<br />

Xeroformium<br />

Vitabiotics<br />

lin. 3g+3g/100g 40g; 100g Sanitas<br />

Nycomed Ireland Ltd<br />

/Nycomed Imaging<br />

AS<br />

Nycomed Ireland Ltd<br />

/Nycomed Imaging<br />

AS<br />

Nycomed Ireland Ltd<br />

/Nycomed Imaging<br />

AS


EN<br />

386 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5903. Visudyne Verteporfinum powder for sol.<br />

for inf.<br />

Strength Manufacturer<br />

15mg/vial -N1 Parkdale<br />

Pharmaceuticals/<br />

Ciba Vision<br />

5904. Vita E 100 mg Tocopherolum tab. 100mg N30 Vitabalans<br />

5905. Vita ES 200 mg RRR-alfa-Tocopherylis<br />

hydrogenosuccinas<br />

tab. 200mg<br />

N30; N60<br />

Vitabalans<br />

5906. Vita-B1 300 mg Thiamini hydrochloridum tab. 300mg N50 Vitabalans<br />

5907. Vita-B6 200 mg Pyridoxinum tab. 200mg N10;N50; N100 Vitabalans<br />

5908. Vitabact Picloxydinum eye drops 0,5mg/ml<br />

10ml<br />

Ciba Vision<br />

Ophthalmics<br />

5909. Vita-C 500 mg Acidum ascorbicum film-coated tab. 500mg N50;N100;N200 Vitabalans<br />

5910. Vitacalcin (Orange flavour) Calcii carbonas (Calcium) oral powder 1,386mg (500mg) N10; N30 Slovakofarma<br />

5911. Vitacalcin (Mandarine flavour) Calcii carbonas (Calcium) oral powder 1,386g (500mg) N10;N30 Slovakofarma<br />

5912. Vitacic Adenosinum+ Thymidinum+<br />

Cytidinum+ Uridinum+<br />

Guanosini-5-dinatrii<br />

monophosphas<br />

eye drops,sol. 200mg+ 200mg+ 600mg+<br />

700mg+ 1,2g/100ml 5ml<br />

Ciba Vision Faure<br />

5913. Vitacon Phytomenadionum sol. for inj. 1mg/0,5ml amp. N10 Polfa Warsaw<br />

5914. Vitacon Phytomenadionum sol. for inj. 10mg/ml 1ml amp. N10 Polfa Warsaw<br />

5915. Vitacon Phytomenadionum coated tab. 10mg<br />

N20; N30<br />

5916. Vita-Iodurol Calcii chloridum+ Magnesii<br />

chloridum+ Acidum<br />

nicotinicum+ Adenosinum<br />

5917. Vital- ratiopharm kapsule˙s Eleutherococcus extractum<br />

siccum<br />

5918. Vitalipid N kūdikiams (sterili<br />

emulsija su vitaminais)<br />

5919. Vitalipid N suaugusiems (sterili<br />

emulsija su vitaminais)<br />

Retinolum+ Ergocalciferolum+<br />

Tocopherolum+<br />

Phytomenadionum<br />

Retinolum+ Ergocalciferolum+<br />

Tocopherolum+<br />

Phytomenadionum<br />

5920. Vital-Tonikum N Ferrosi gluconas+ Extr.fol.cum<br />

flor.Crataegi siccum (5:1)+<br />

Extr. fol. Melissae siccum (4,2-<br />

6,3:1) +Extr.fruct.Crataegi<br />

spisum (2,5:1)<br />

5921. Vitamin B complex Thiaminum+Riboflavinum+<br />

Pyridoxinum+ Nicotinamidum<br />

5922. Vitamin B compositum Thiaminum+ Riboflavinum+<br />

Pyridoxinum+<br />

Nicotinamidum+ Calcii<br />

pantothenas<br />

eye drops, sol. 200mg+ 300mg+30mg+<br />

100mg/ 100ml 10ml<br />

Polfa Warsaw<br />

caps. 50mg N30 Merckle<br />

concentrate for<br />

sol. for inf.<br />

concentrate for<br />

sol. for inf.<br />

230 UI+40 UI+0,7 UI+<br />

20µg/ml 10ml amp. N10<br />

330 UI+ 20 UI+1UI+ 15µg/ml<br />

10ml amp. N10<br />

oral sol. 2mg+ 1,52mg+ 1,42mg+<br />

0,645mg/ml 500ml; 1000ml<br />

film-coated tab. 5mg+1mg+<br />

4mg+50mg N20<br />

coated tab. 3mg+5mg+ 5mg+40mg+5mg<br />

N50<br />

5923. Vitamin B1 Thiaminum sol. for inj. 10mg/ml<br />

N10; N50 amp.<br />

5924. Vitamin B1 forte Thiaminum sol. for inj. 25mg/ml<br />

N10; N50 amp.<br />

Ciba Vision Faure<br />

Fresenius Kabi<br />

Fresenius Kabi<br />

Herzpunkt Pharma<br />

Sopharma PLC<br />

Pliva Krakow<br />

Pliva Krakow<br />

Pliva Krakow<br />

5925. Vitamin B2 Riboflavinum sol. for inj. 5mg/ml N5 amp. Pliva Krakow


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 387<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5926. Vitamin B2 Riboflavinum coated tab. 3mg N50 Pliva Krakow<br />

5927. Vitamin B6 Pyridoxinum sol. for inj. 50mg/2ml<br />

N5; N10 amp.<br />

5928. Vitamin D<br />

5 000-Slovakofarma<br />

Colecalciferolum caps. 5000UI<br />

N30<br />

5929. Vitamin D 800-Slovakofarma Colecalciferolum caps. 800UI<br />

N30<br />

Pliva Krakow<br />

Slovakofarma<br />

Slovakofarma<br />

5930. Vitamin E Tocopherolum sol.for inj. 300mg/ml 1ml amp. N5 Polfa Warsaw<br />

5931. Vitamin E 100-Slovakofarma Tocopherolum caps. 100mg<br />

N30<br />

Slovakofarma<br />

5932. Vitamin E 200-Slovakofarma Tocopherolum caps. 200mg N30 Slovakofarma<br />

5933. Vitamin E 400-Slovakofarma Tocopherolum caps. 400mg N30 Slovakofarma<br />

5934. Vitamin E peach flavour Tocopherolum chewable tab. 100mg<br />

N100<br />

Nycomed Pharma<br />

5935. Vitamin PP Nicotinamidum sol. for inj. 100mg/2ml amp. N5 Pliva Krakow<br />

5936. Vitaminai A ir D3 Retinoli palmitas+<br />

Colecalciferolum<br />

oral sol. 20 000 UI+ 10 000 UI/ml<br />

10ml<br />

Medana Pharma<br />

Terpol<br />

5937. Vitaminas A30 000+E70 Retinolum+ Tocopherolum caps. 30000UI+ 70mg N30 Hasco-Lek/Korio<br />

laboratorija<br />

5938. Vitaminas A Retinoli palmitas caps. 1200UI<br />

N50<br />

Glaxo Wellcome<br />

Poznan<br />

5939. Vitaminas A Retinoli palmitas caps. 12000UI N50 Hasco-Lek/Korio<br />

laboratorija<br />

5940. Vitaminas A Retinoli palmitas oral sol. 50 000 UI/ml 10ml Medana Pharma<br />

Terpol<br />

5941. Vitaminas A+E Retinoli acetas+Tocopheroum caps. 30000UI+<br />

70mg<br />

N30<br />

Glaxo Wellcome<br />

Poznan<br />

5942. Vitaminas B6 Pyridoxini hydrochloridum tab. 50mg N50 Pliva Krakow<br />

5943. Vitaminas B6 Piridoksino<br />

vandenilio chlorides 5 mg<br />

Pyridoxini hydrochloridum tab. 5mg N30;N50 Liuks<br />

5944. Vitaminas C 500 mg Acidum ascorbicum tab. 500mg<br />

N50<br />

5945. Vitaminas E Tocopherolum caps. 100mg<br />

N30<br />

Bakteriniai<br />

preparatai<br />

Glaxo Wellcome<br />

Poznan<br />

5946. Vitaminas E Tocopherolum caps. 100mg N30 Hasco-Lek/Korio<br />

laboratorija<br />

5947. Vitaminas E Tocopherolum oral sol. 300mg/ml 10ml Medana Pharma<br />

Terpol<br />

5948. Vitaminas E 400 mg Tocopherolum caps. 400mg<br />

N30<br />

Hasco-Lek<br />

5949. Vitamine D3 B.O.N. Colecalciferolum sol. for inj. 200000IU/ml 1ml amp. Doms Adrian<br />

5950. Vitamininis vaistazˇoliu˛ mišinys<br />

Nr.2<br />

Rosae fructus+ Sorbi fructus herbal tea 50g+50g 100g;50g;<br />

50g(2g×25)<br />

Švenčioniu˛<br />

vaistazˇole˙s


EN<br />

388 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5951. Vitamino B komplekso tablete˙s Multivitaminai tab. N30; N50; N60; N100 Liuks<br />

5952. Vitaminu˛ A ir E tablete˙s Multivitaminai tab. N30; N50; N60; N100 Liuks<br />

5953. Vitaminu˛ B kompleksas,<br />

tirpalas injekcijoms<br />

5954. Vitaminu˛ B komplekso<br />

stipriojo tablete˙s<br />

Thiamini chloridum<br />

Pyridoxini hydrochloridum<br />

Cyanocobalaminum<br />

Thiaminum+<br />

Riboflavinum+<br />

Nicotinamidum+ Pyridoxinum<br />

sol. for. inj. B 1 100 mg<br />

B 6 100 mg<br />

B 12 1mg<br />

5955. Vitaminum C 100 mg Acidum ascorbicum coated tab. 100mg<br />

N50<br />

5956. Vitaminum C 200 mg Acidum ascorbicum coated tab. 200mg<br />

N50<br />

5957. Vitamult syrup Retinolum+ Colecalciferolum+<br />

Thiaminum+ Riboflavinum+<br />

Pyridoxinum+<br />

Nicotinamidum+ Pantenolum+<br />

Acidum ascorbicum<br />

5958. Vitaphakol Cytochromum C+Natrii<br />

succinas+Adenosinum+<br />

Nicotinamidum<br />

5959. Vitaral Retinolum+Thiaminum+<br />

Riboflavinum+ Pyridoxinum+<br />

Cyanocobalaminum+Acidum<br />

ascorbicum +<br />

Colecalciferolum+<br />

Tocopherolum+<br />

Nicotinamidum+Calcii<br />

pantothenas+Acidum folicum+<br />

Rutosidum+ Calcium+<br />

Phosphorus+Ferrum (II)+<br />

Manganum+ Magnesium+<br />

Fluorum+ Kalium+ Zincum +<br />

Iodum+ Molybdenum<br />

5960. Vitiron Suscaps Retinolum+ Colecalciferolum+<br />

Thiaminum+ Riboflavinum+<br />

Pyridoxinum+<br />

Cyanocobalaminum+<br />

Tocopherolum+<br />

Nicotinamidum+ Acidum<br />

pantothenicum+ Acidum<br />

ascorbicum+ Acidum folicum+<br />

Calcium+Phosphorus+<br />

Magnesium+ Cuprum+<br />

Ferrum+ Manganum+ Zincum<br />

+ Molybdenum+ Iodum+<br />

Kalium<br />

Endokrininiai<br />

preparatai<br />

tab. 5mg+2mg+ 20mg+2mg N50 Endokrininiai<br />

preparatai<br />

syrup 500IU+ 150IU+ 1,25mg+<br />

1,5mg+ 1,25mg+ 12,5mg+<br />

1,25mg+ 37,5mg/5ml 110ml<br />

eye drops,sol. 0,5mg+0,6mg+2mg+ 10mg/ml<br />

10ml<br />

coated tab. 4000 UI + 1mg+2mg+<br />

0,125mg+ 1µg+30mg+<br />

400 UI+ 0,25mg + 10mg+<br />

1mg+ 0,2mg+5mg+ 59mg+<br />

45,5mg+6,15mg+ 0,33mg+<br />

0,12mg+ 0,166mg+<br />

0,138mg+ 17µg+50µg+2,7µg+<br />

0,6µg N30;N60<br />

caps. (suscaps) 3333IU+ 1000IU+ 5mg+<br />

2,5mg+ 0,5mg+ 1µg+2mg+<br />

40mg+4mg+75mg+ 0,5mg+<br />

75mg+ 58mg+3mg+0,45mg+<br />

30mg+ 0,5mg+ 0,5mg+<br />

0,1mg+ 0,075mg+ 2mg N30<br />

Polfa Grodzisk<br />

Polfa Grodzisk<br />

CTS<br />

Ciba Vision Faure<br />

5961. Vitrum Tablets Multivitamin and Minerals tab. N100 Unipharm<br />

5962. Voltaren 75 mg/3ml inj. Diclofenacum sol. for inj. 75mg/3ml amp. N5 Novartis Pharma<br />

5963. Voltaren 100 Diclofenacum supp. 100mg<br />

N5<br />

5964. Voltaren 25 Diclofenacum enteric-coated<br />

tab.<br />

25mg<br />

N30<br />

5965. Voltaren 25 Diclofenacum natricum supp. 25mg<br />

N10<br />

Jelfa<br />

Mepha<br />

Novartis Pharma<br />

Novartis Pharma<br />

Novartis Pharma


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 389<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

5966. Voltaren 50 Diclofenacum enteric-coated<br />

tab.<br />

50mg<br />

N20<br />

5967. Voltaren 50 Diclofenacum supp. 50mg<br />

N5; N10<br />

5968. Voltaren Emulgel Diclofenacum diethylaminum<br />

(Diclofenacum natricum)<br />

gel 10mg/g<br />

50g<br />

5969. Voltaren Retard 100 Diclofenacum coated tab. 100mg<br />

N30<br />

5970. Voluven Poly(0-2-hydrohyethyl)amylum+<br />

Natrii chloridum<br />

5971. V-Penicilin 250mg-<br />

Slovakofarma<br />

5972. V-Penicilin 500mg-<br />

Slovakofarma<br />

5973. V-Penicilin 750 mg-<br />

Slovakofarma<br />

5974. Warfarin 3-SL Warfarinum natricum<br />

clathratum<br />

5975. Warfarin 5-SL Warfarinum natricum<br />

clathratum<br />

Strength Manufacturer<br />

Novartis Pharma<br />

Novartis Pharma<br />

Novartis Pharma<br />

Novartis Pharma<br />

sol. for inf 60g+9g/l 250ml; 500ml Fresenius Kabi<br />

Phenoxymethyl-penicillinum tab. 250mg (440 000 UI) N30 Slovakofarma<br />

Phenoxymethylpenicillinum tab. 500mg (880 000 UI) N30 Slovakofarma<br />

Phenoxymethylpenicillinum tab. 750mg<br />

N30<br />

Slovakofarma<br />

tablets 3mg N100 Slovakofarma<br />

tablets 5mg N100 Slovakofarma<br />

5976. Wartec Podophyllotoxinum sol. 5mg/ml 3ml Stiefel<br />

5977. Wartec cream Podophyllotoxinum cream 0,15% 5g Stiefel<br />

5978. Wart-off Acidum salicylicum sol. 17% 13,3ml Pfizer<br />

5979. Wellbutrin SR Bupropioni hydrochloridum<br />

(Amfebutamonum)<br />

sustainedreleasefilmcoated<br />

tab.<br />

5980. Wellferon Interferonum alfa sol. for inj. 3MU/ml<br />

N1<br />

5981. Wellferon Interferonum alfa sol. for inj. 5MU/ml<br />

N1<br />

5982. Wellferon Interferonum alfa sol. for inj. 10MU/ml<br />

N1<br />

5983. Wellman Retinolum+ Betacarotenum+<br />

Colecalciferolum+ Acidum<br />

ascorbicum+ Thiaminum+<br />

Riboflavinum+ Pyridoxinum+<br />

Cyanocobalaminum+<br />

Biotinum+ Acidum folicum+<br />

Nicotinamidum+ Acidum<br />

pantothenicum+<br />

Tocopherolum+ Argininum+<br />

Methioninum+ Acidum<br />

paminobenzoicum+<br />

Ferrum(II)+ Magnesium<br />

5984. Wheatgerm oil (‘Ypatingasis<br />

daigintu˛ kvie-čiu˛ aliejus’)<br />

150mg N30; N60 Glaxo Wellcome<br />

caps. 750µg+ 5mg+5µg+ 60mg+<br />

12mg+5mg+ 9mg+9µg+<br />

50µg+ 500µg+ 20mg+ 10mg+<br />

20mg+ 20mg+ 20mg+ 20mg+<br />

6mg+50mg+ 15mg+ 150µg+<br />

3mg+ 1,5mg+ 50µg+ 150µg+<br />

10mg+ 20mg+ 20mg+10mg<br />

N30<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Vitabiotics<br />

Ol.Tritici+ Tocopherolum caps., soft 260mg+ 10IU N100 Arco-Chemie<br />

5985. Wilprafen Josamycinum film-coated tab. 500mg<br />

N10<br />

Yamanouchi<br />

5986. Wilprafen Josamycinum oral susp. 300mg/10ml 100ml Yamanouchi


EN<br />

390 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

5987. Wilprafen forte Josamycinum oral susp. 600mg/10ml 100ml Yamanouchi<br />

5988. Winter Eeze Zinc lozenges Acidum ascorbicum+ Zinci<br />

citras+ Echinacea purpurea<br />

extractum radix+ Echinacea<br />

augustifolia extractum radix<br />

5989. Wobe-Mugos E Trypsinum+<br />

Chymotrypsinum+<br />

Papainum<br />

5990. Wobenzym Pancreatinum+Papainum+<br />

Rutosidum+Bromelainum+<br />

Trypsinum+Lipasum+<br />

Amylasum+<br />

Chymotrypsinum<br />

5991. Wolff Basis Creme Hydrophile Creme vom Typ<br />

O/W-Emulsion<br />

lozenges 60mg+ 13,3mg+ 5mg N18 Leiner<br />

film-coated<br />

gastro- resistant<br />

tab.<br />

gastro-resistant<br />

tab.<br />

5992. Xalatan Latanoprostum eye drops, sol. 50µg/ml<br />

2,5ml<br />

40mg+40mg+<br />

100mg N20; N40; N100<br />

100mg+60mg+50mg+ 45mg+<br />

24mg+10mg+<br />

10mg+1mg N40; N200; N800<br />

cream 25% 50g; 100g; 250g; 700g Wolff<br />

Mucos<br />

Emulsionsgesellschaft<br />

Mucos<br />

Emulsionsgesellschaft<br />

Pharmacia & Upjohn<br />

5993. Xalcom Latanoprostum+ Timololum eye drops, sol. 50µg+5mg/ml 2,5ml Pharmacia & Upjohn<br />

5994. Xanax tablets 0,25 mg Alprazolamum tab. 0,25mg<br />

N30; N100<br />

5995. Xanax tablets 0,5 mg Alprazolamum tab. 0,5mg<br />

N30; N100<br />

5996. Xanax tablets 1 mg Alprazolamum tab. 1mg<br />

N30; N100<br />

5997. Xanax XR Alprazolamum prolongedrelease<br />

tab.<br />

5998. Xanax XR Alprazolamum prolongedrelease<br />

tab.<br />

5999. Xanax XR Alprazolamum prolongedrelease<br />

tab.<br />

2mg<br />

N30<br />

1mg<br />

N30<br />

0,5mg<br />

N30<br />

6000. Xantinol nicotinate Xantinoli nicotinas retard tab. 500mg<br />

N20<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia N.V./S.A.<br />

Pharma<br />

cia N.V./S.A.<br />

Pharmacia N.V./S.A.<br />

Pliva Krakow<br />

6001. Xantinol nicotinate Xantinoli nicotinas sol. for inj. 300mg/2ml N10; N50 amp. Pliva Krakow<br />

6002. Xantinol nicotinate Xantinoli nicotinas tab. 150mg N30 Pliva Krakow<br />

6003. Xatral 2,5 mg Alfuzosinum film-coated tab. 2,5mg N30 Synthelabo<br />

6004. Xatral SR 10 mg Alfuzosinum prolongedrelease<br />

tab.<br />

6005. Xatral SR 5 mg Alfuzosinum sustainedreleasefilmcoated<br />

tab.<br />

6006. Xefo Lornoxicamum powder and<br />

solvent for sol.<br />

for inj.<br />

10mg N30 Synthelabo<br />

5mg N28; N56 Synthelabo<br />

8mg/vial N1+2ml amp.<br />

(solvent) N1<br />

Nycomed Austria<br />

6007. Xefo Lornoxicamum tab. 4mg N20 Nycomed Austria<br />

6008. Xefo Lornoxicamum tab. 8mg N20 Nycomed Austria<br />

6009. Xeloda Roche Capecitabinum tab. 500mg N120 Roche


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 391<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

6010. Xeloda Roche Capecitabinum tab. 150mg N60 Roche<br />

6011. Xenical Orlistatum caps. 120mg N21; N42 Roche<br />

6012. Xenna Standardized Senna<br />

concentrate (containing of<br />

Sennosides A and B)<br />

6013. Xenna Sennae fructus pulvis+Calcii<br />

senosida<br />

6014. Xeroformium (Bismuth<br />

Tribromophenate)<br />

tab. 217mg (6,5mg)<br />

N2; N20<br />

tab. 120mg+ 13mg<br />

N2; N20<br />

Unilab<br />

OHM Laboratories/<br />

US Pharmacia<br />

Bismuth tribromophenate substance 90-100% Omicron Quimica<br />

6015. Xorox — Cream Aciclovirum cream 50mg/g 2g Kwizda<br />

6016. Xorox — Eye ointment Aciclovirum eye ointment 30mg/g 4,5g Kwizda<br />

6017. Xorox 200mg — tablets Aciclovirum tab. 200mg N25 Kwizda<br />

6018. Xorox 250mg — dry<br />

substance<br />

Aciclovirum powder for<br />

sol.for inf.<br />

250mg/amp. N5 Kwizda<br />

6019. Xorox 400mg — tablets Aciclovirum tab. 400mg N60 Kwizda<br />

6020. Xorox 800mg — tablets Aciclovirum tab. 800mg N35 Kwizda<br />

6021. X-Prep Extr.siccum fruct. Sennae<br />

acutifoliae<br />

oral sol. 2g/75ml Mundipharma<br />

6022. Xylestesin-A Lidocainum+ Epinephrinum sol. for inj. 20mg+0,0125mg/ml 1,7ml<br />

cartridges N50<br />

6023. Xylocaine adrenaline Lidocainum+ Epinephrinum sol. for inj. 20mg+ 12,5µg/ml Astra<br />

3M ESPE<br />

6024. Xylodont 2% Lidocainum sol. for inj. 20mg/ml 1,8ml cartridge N50 Molteni<br />

6025. Xylodont 2% Adrenaline<br />

1:100 000<br />

6026. Xylodont 2% Adrenaline<br />

1:50 000<br />

6027. Xylodont 2% Adrenaline<br />

1:80 000<br />

Lidocainum+ Epinephrinum sol. for inj. 20mg+ 10µg/ml 1,8ml<br />

cartridge N50<br />

Lidocainum+ Epinephrinum sol. for inj. 20mg+ 20µg/ml 1,8ml<br />

cartridge N50<br />

Lidocainum+ Epinephrinum sol. for inj. 20mg+ 12,5µg/ml 1,8ml<br />

cartridge N50<br />

6028. Xylometazolin Xylometazolinum nasal drops, sol. 1mg/ml<br />

10ml<br />

Molteni<br />

Molteni<br />

Molteni<br />

ICN Polfa Rzeszow<br />

6029. Xylometazolin Xylometazolinum nasal drops, sol. 0,5mg/ml 10ml ICN Polfa Rzeszow<br />

6030. Xylometazolin Xylometazolinum nasal gel 100mg/100g 5g Glaxo Wellcome<br />

Poznan<br />

6031. Xylometazolin Xylometazolinum nasal gel 50mg/100g 5g Glaxo Wellcome<br />

Poznan<br />

6032. Xylonor 3 % noradrenaline Lidocainum+<br />

Noradrenalinum<br />

sol. for inj. 54mg+ 0,072mg/1,8ml<br />

cartridge N50<br />

Septodont<br />

6033. Xymelin Xylometazolinum nasal drops 1mg/ml 10ml Nycomed Danmark<br />

6034. Xymelin Xylometazolinum nasal spray 1mg/ml 15ml Nycomed Pharma<br />

6035. Xymelin Xylometazolinum nasal drops, sol. 1mg/ml (single dose<br />

bottelpack)<br />

6036. Yarina Drospirenonum+<br />

Ethinylestradiolum<br />

Nycomed DAK<br />

film-coated tab. 3mg+30µg N21 Schering


EN<br />

392 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

6037. Yellon beta-Aescinum+ Heparinum gel 250mg+ 9,5mg/50g 50g Slovakofarma<br />

6038. Yogurt Lactobacillus acidophilus+<br />

Lactobacillus bifidus +Jogurto<br />

kultūra (Streptococcus<br />

thermophilus+Lactobacillus<br />

delbrueckii subsp. bulgaricus)<br />

6039. Your Life Cardio Complex Tocopherolum+Piridoxinum+<br />

Acidum folicum+<br />

Cyanocobalaminum<br />

6040. Your Life Daily Pack Maximum Each packet includes:Mega<br />

potency multivitamin<br />

(1caplet);Vitamin C<br />

(1 caplet);Vitamin<br />

E(1caps.,soft);Sibirian<br />

ginseng(1caplet); Chromium<br />

picolinate(1tablet)<br />

6041. Your Life Daily Pak Essential Each packet contains:Premium<br />

Multivitamin with<br />

herbs(1caplet); Vitamin<br />

C(1caplet); Vitamin E<br />

(1 caps.,soft);Calcium,<br />

Magnesium, Zinc(1 tablet)<br />

6042. Your Life Natural Vitamin C<br />

with Echinacea<br />

6043. Your Life Super Multi-vitamin<br />

with Herbs<br />

6044. Your Life Women's Cycle<br />

Multivitamin<br />

Ascorbic acid+ Powder of herb<br />

Echinacea purpurea+ Powder<br />

of herb Echinacea angustifolia+<br />

Powder of roots of Echinacea<br />

angustifolia<br />

Retinoli acetas, palmitas et<br />

betacarotenum+<br />

Ergocalciferolum+ Tocopheroli<br />

acetas+Acidum ascorbicum+<br />

Phytomenadionum+<br />

Thiaminum+ Riboflavinum+<br />

Nicotinamidum+Pyridoxinum+<br />

Acidum folicum+<br />

Cyanocobalaminum+<br />

Biotinum+ Acidum<br />

pantothenicum+Calcium+<br />

Ferrum+Iodum+ Magnesium<br />

Retinolum+ Acidum<br />

ascorbicum+<br />

Ergocalciferolum+<br />

Tocopherolum+<br />

Phytomenadionum+<br />

Thiaminum+Riboflavinum+<br />

Acidum nicotinicum+<br />

Pyridoxinum+Acidum<br />

folicum+ Cyanocobalaminum+<br />

Biotinum+ Calcii<br />

panthothenas+Calcii<br />

phosphas+Ferrosi fumaras+<br />

Kalii iodidum+ Magnii oxidum<br />

6045. Ypsiloheel Asa foetida D4+ Ignatia D4+<br />

Paris quadrifolia D4+ Thuja<br />

occidentalis D6+Pulsatilla<br />

pratensis D4+ Lachesis mutus<br />

D8 +Moschus moschiferus<br />

D6+ Glonoinum D6<br />

caps. 1,73×10(9)+ 0,54×10(9)+<br />

0,04×10(9) N30<br />

caps., soft 400IU+ 2mg+ 400µg+ 6µg<br />

N60<br />

packets of filmcoated<br />

tab.,<br />

caplets and<br />

caps.,soft<br />

packets<br />

of:caplet;<br />

caps.,soft; tab.<br />

Pharmascience<br />

Leiner<br />

N30 Leiner<br />

N30 Leiner<br />

coated tab. 500mg+ 50mg+ 35mg+ 15mg<br />

N60<br />

coated tab. 500IU+400IU+60IU+ 120mg+<br />

80µg+1,5mg+,7mg+ 20mg+<br />

2mg+ 400µg+12µg+30µg+<br />

10mg+225mg+9mg+ 150µg+<br />

100mg+15mg+ 70µg+2mg+<br />

2mg+120µg+75µg+150µg+<br />

25mg+ 25mg+25mg N75<br />

tab. (capl.) 5000IU+ 60mg+ 400IU+<br />

45IU+ 65µg+ 2mg+ 2,5mg+<br />

8,5mg+ 3mg+ 300mg+ 6µg+<br />

200µg+ 10mg+ 160mg+<br />

15mg N28<br />

tab. 30mg+30mg+ 30mg+30mg+<br />

45mg+45mg+ 45mg+45mg<br />

6046. Zaditen Ketotifenum eye drops, sol. 0,25mg/ml 5ml Ciba Vision Faure<br />

6047. Zaditen 1mg Ketotifenum tab. 1mg N30 Novartis<br />

Leiner<br />

Leiner<br />

Leiner<br />

Heel


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 393<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

6048. Zanocin Ofloxacinum film-coated tab. 200mg<br />

N10<br />

6049. Zanocin Ofloxacinum solution for<br />

infusion<br />

6050. Zantac Ranitidinum tab. 150mg<br />

N20; N60<br />

Strength Manufacturer<br />

Ranbaxy<br />

200mg/100ml 100ml Ranbaxy<br />

Laboratories Limited<br />

6051. Zantac Ranitidinum tab. 300mg N10;N30 Glaxo<br />

6052. Zantac Ranitidinum sol. for inj. 25mg/ml<br />

2ml amp.N5<br />

Glaxo<br />

Glaxo Wellcome<br />

6053. Zantac Ranitidinum tab. 75mg Glaxo Wellcome<br />

6054. Zantac<br />

150 mg effervescent tablets<br />

6055. Zantac<br />

300 mg effervescent tablets<br />

Ranitidinum efferv. tab. 150mg N2;N6; N10 Glaxo Wellcome<br />

Ranitidinum efferv. tab. 300mg N10 Glaxo Wellcome<br />

6056. Zavedos Idarubicinum caps. 5mg<br />

N1<br />

6057. Zavedos Idarubicinum caps. 10mg<br />

N1<br />

6058. Zavedos Idarubicinum caps. 25mg<br />

N1<br />

6059. Zavedos Idarubicinum powder for inj. 5mg<br />

N1<br />

6060. Zavedos Idarubicinum powder for inj. 10mg<br />

N1<br />

6061. Zeel P compos. sol. for inj. packs containing 10, 50 and<br />

100 amp. of 2,2ml<br />

6062. Zeel T Cartilago suis D2+ Funiculus<br />

umbilicalis suis D2 +Embryo<br />

suis D2 +Placenta suis D2 +<br />

Toxicodendron quercifolium e<br />

summitatibus rec.D2+ Arnica<br />

montana D2+ Solanum<br />

dulcamara D2+ Symphytum<br />

D8+ Sanguinaria canadensis<br />

D2 +Sulfur D6 +Nadidum D6<br />

+Coenzym A D6+Acidum alfa-<br />

..<br />

6063. Zeel T Cartilago suis D4+ Funiculus<br />

umb. suis D4+ Embryo suis<br />

D4 +Placenta suis D4 +<br />

Toxicodendron querc. D2+<br />

Arnica D1+ Solanum dulc.<br />

D2+ Symphytum D8+<br />

Sanguinaria D3 + Sulfur D6 +<br />

Nadidum D6 +Coenzyme A<br />

D6+Ac. Alphaliponicum D6 +<br />

Natrium diethyloxalac. D6+Ac.<br />

silicicum D6<br />

ointment 1mg+1mg+1mg+1mg+<br />

270mg+ 300mg+75mg+<br />

750mg+ 225mg+ 270mg+<br />

10mg+10mg+ 10mg+10mg+<br />

1g/100g 50g;100g<br />

tab. 0,3mg+0,3mg+0,3mg+<br />

0,3mg+ 0,54mg+ 0,6mg+<br />

0,15mg+ 0,15mg+ 0,45mg+<br />

0,54mg+ 0,03mg+ 0,03mg+<br />

0,03mg+ 0,03mg+3mg N50<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Pharmacia & Upjohn<br />

Biologische<br />

Heilmittel Heel<br />

GmbH<br />

6064. Zeffix Lamivudinum film-coated tab. 100mg N28;N84 Glaxo Wellcome<br />

Heel<br />

Heel


EN<br />

394 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

6065. Zeffix Lamivudinum oral sol. 5mg/ml<br />

240ml<br />

Strength Manufacturer<br />

Glaxo Wellcome<br />

6066. Zeldox 20mg Ziprasidonum capsules, hard 20mg N14;N30; N100 Heinrich Mack<br />

Nachf. GmbH & Co.<br />

6067. Zeldox 20mg/ml Ziprazidonum powder and<br />

solvent for<br />

solution for<br />

injection<br />

20mg/ml 1 vial+1 amp. of<br />

solvent<br />

Ben Venue<br />

Laboratories, JAV/<br />

Pfizer, Prancūzija<br />

6068. Zeldox 40mg Ziprasidonum capsules, hard 40mg N14;N30; N100 Heinrich Mack<br />

Nachf. GmbH & Co.<br />

6069. Zeldox 60mg Ziprasidonum capsules, hard 60mg N14;N30; N100 Heinrich Mack<br />

Nachf. GmbH & Co.<br />

6070. Zeldox 80mg Ziprasidonum capsules, hard 80mg N14;N30; N100 Heinrich Mack<br />

Nachf. GmbH & Co.<br />

6071. Zelenino lašai BP Tinctura Belladonnae+<br />

Tinctura Convallariae+<br />

Tinctura Valerianae +<br />

Mentholum seu Mentholum<br />

racemicum<br />

6072. Zelmac 6mg tablets Tegaserod (as hydrogen<br />

maleate)<br />

6073. Zˇen Šen Ginseng Ginsengi radix extractum<br />

siccum (3:1)<br />

6074. Zenapax Dacliximabum conc. for sol.<br />

for inf.<br />

6075. Zˇenšenio tinktūra Ginseng radix+ Ethanolum<br />

40%<br />

6076. Zepilen Cefazolinum powder for<br />

solution for<br />

injection<br />

drops, liq. 0,2ml+0,4ml+0,4ml+8mg/ml<br />

25ml;50ml<br />

Bakteriniai<br />

preparatai<br />

tablets 6mg N30 Novartis Pharma<br />

Stein<br />

caps. 350mg N24 KRKA<br />

25mg/5ml N1; N3 Roche<br />

tinct. 10g+ 90g 10ml; 25ml; 50ml KMU vaistine˙<br />

1000mg/vial N10 Medochemie<br />

6077. Zeptol 200 Carbamazepinum tab. 200mg N100 Sun<br />

6078. Zerit Stavudinum caps. 15mg<br />

N56; N60<br />

6079. Zerit Stavudinum caps. 40mg<br />

N56; N60<br />

6080. Zerit Stavudinum caps. 20mg<br />

N56; N60<br />

6081. Zerit Stavudinum powder for oral<br />

sol.<br />

6082. Zerit Stavudinum caps. 30mg<br />

N56; N60<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

Bristol-Myers Squibb<br />

1mg/ml Bristol-Myers Squibb<br />

6083. Zerocid Omeprazolum caps. 20mg N100 Sun<br />

Bristol-Myers Squibb<br />

6084. Ziagen Abacavirum oral sol. 20mg/ml 240ml Glaxo Wellcome<br />

6085. Ziagen Abacavirum film-coated tab. 300mg<br />

N60<br />

Glaxo Wellcome


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 395<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

6086. Zinacef Cefuroximum powder for<br />

susp. for inj.<br />

i.v., i.m.<br />

6087. Zinacef Cefuroximum powder for<br />

susp. for inj.<br />

i.v., i.m.<br />

6088. Zinacef Cefuroximum powder for<br />

susp. for inj.<br />

i.v., i.m.<br />

1,5g<br />

N1<br />

750mg<br />

N1<br />

Strength Manufacturer<br />

Glaxo<br />

Glaxo<br />

250mg N1 Glaxo<br />

6089. Zinnat Cefuroximum oral susp. 250mg/5ml 100ml Glaxo Wellcome<br />

6090. Zinnat Cefuroximum tab. 125mg N10 Glaxo<br />

6091. Zinnat Cefuroximum tab. 250mg N10 Glaxo<br />

6092. Zinnat Cefuroximum tab. 500mg N10 Glaxo<br />

6093. Zinnat Cefuroximum granules for<br />

oral susp.<br />

125mg/5ml 50ml, 100ml;<br />

125mg/sachet<br />

6094. Zitazonium Tamoxifenum tab. 20mg N10 Egis<br />

6095. Zitazonium Tamoxifenum tab. 30mg N10 Egis<br />

6096. Zitazonium Tamoxifenum tab. 40mg N10 Egis<br />

6097. Zitazonium Tamoxifenum tab. 10mg N30 Egis<br />

6098. Zˇmogaus albumino 10 %<br />

tirpalas<br />

6099. Zˇmogaus albumino 20 %<br />

tirpalas<br />

6100. Zˇmogaus albumino 5 %<br />

tirpalas<br />

6101. Zˇmogaus anti-D<br />

imunoglobulinas<br />

6102. Zˇmogaus augimo hormonas<br />

rekombinantinis<br />

Albuminum humanum sol. for inf. 100g/1000ml 50ml;100ml;<br />

200ml<br />

Glaxo<br />

Vilniaus kraujo<br />

centras<br />

Albuminum humanum sol. for inf. 200g/1000ml 50ml;100ml Vilniaus kraujo<br />

centras<br />

Albuminum humanum sol. for inf. 50g/1000ml 200ml; 400ml Vilniaus kraujo<br />

centras<br />

Immunoglobulinum humanum<br />

anti-D<br />

Hormonum incrementi<br />

humanum recombinatum<br />

6103. Zˇmogaus fibrinogenas Fibrinogenum humanum powder for<br />

sol.for inf.<br />

6104. Zˇmogaus normalaus<br />

imunoglobulino 5 % tirpalas<br />

intraveniniam vartojimui<br />

6105. Zˇmogaus normalus<br />

imunoglobulinas<br />

sol. for inj. 100-300µg/ml 1ml amp. N10 Vilniaus kraujo<br />

centras<br />

subst. (sol.) >2,8mg/ml 25ml;50ml;100ml;<br />

250ml;500ml<br />

Biotechna<br />

0,8g-1,5g Vilniaus kraujo<br />

centras<br />

Immunoglobulinum humanum sol. for inf. 50mg/ml 25ml;50ml;100ml Vilniaus kraujo<br />

centras<br />

Immunoglobulinum humanum sol. for inj. 100mg/ml 1,5ml amp.N10 Vilniaus kraujo<br />

centras<br />

6106. Zocor Simvastatinum film-coated tab. 20mg N28 MSD<br />

6107. Zocor Simvastatinum film-coated tab. 40mg N28 MSD<br />

6108. Zocor Simvastatinum film-coated tab. 10mg N28 MSD<br />

6109. Zocor Simvastatinum film-coated tab. 80mg<br />

N28<br />

6110. Zodac Cetirizini dihydrochloridum film-coated tab. 10mg N10;N30 Lečiva<br />

MSD


EN<br />

396 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

6111. Zofenil 30mg Zofenoprilum film-coated<br />

tablets<br />

6112. Zofenil 7,5mg Zofenoprilum film-coated<br />

tablets<br />

6113. Zofran Ondansetronum syrup (sugarfree)<br />

6114. Zofran Ondansetronum sol. for inj. 2mg/ml<br />

amp. 2ml N5; 4ml N5<br />

6115. Zofran Ondansetronum tab. 4mg<br />

N10<br />

6116. Zofran Ondansetronum tab. 8mg<br />

N10<br />

Strength Manufacturer<br />

30mg N7;N14;N28 Berlin-Chemie AG<br />

(Menarini Group)<br />

7,5mg N7;N14;N28 Berlin-Chemie AG<br />

(Menarini Group)<br />

4mg/5ml 50ml Glaxo Wellcome<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

Glaxo Wellcome<br />

6117. Zofran Zydis Ondansetronum oral lyophilizate 4mg N10 Glaxo Wellcome<br />

Operations<br />

6118. Zofran Zydis Ondansetronum oral lyophilizate 8mg N10 Glaxo Wellcome<br />

Operations<br />

6119. Zoladex Goserelinum sterile depot<br />

implantab.<br />

6120. Zoladex LA 10,8 mg Depot Goserelinum inj. caps. in<br />

syringe<br />

3,6mg pre-filled syringe N1 AstraZeneca<br />

10,8mg<br />

N1<br />

6121. Zoleptil 100 Zotepinum coated tab. 100mg N20;N50 Ebewe<br />

6122. Zoleptil 25 Zotepinum coated tab. 25mg N20;N50 Ebewe<br />

6123. Zoleptil 50 Zotepinum coated tab. 50mg N20;N50 Ebewe<br />

6124. Zolim Mizolastinum prolongedrelease<br />

tablets<br />

6125. Zoloft Sertralinum concentrate for<br />

oral sol.<br />

10mg N10;N20 KRKA<br />

20mg/ml<br />

60ml<br />

6126. Zoloft Sertralinum film coated. tab. 50mg<br />

N28<br />

6127. Zomacton Somatropinum powder and<br />

solvent for sol.<br />

for inj.<br />

6128. Zometa 4mg Acidum zoledronicum powder and<br />

solvent for<br />

solution for<br />

infusion<br />

4mg/vial+ amp. of solvent<br />

(Natrii chloridum 31,5mg;<br />

Alcohol benzylicus<br />

31,5mg/3,5ml) N1; N5<br />

6129. Zomig Zolmitriptanum tab. 2,5mg<br />

N3; N6; N18<br />

4mg/vial+5ml amp. with water<br />

for inj.<br />

6130. Zomiren 0,25 mg Alprazolamum tab. 0,25mg N30 KRKA<br />

6131. Zomiren 0,5 mg Alprazolamum tab. 0,5mg N30 KRKA<br />

6132. Zomiren 1mg Alprazolamum tab. 1mg N30 KRKA<br />

AstraZeneca<br />

Mack<br />

Pfizer<br />

Ferring<br />

Novartis Pharma<br />

Stein<br />

AstraZeneca


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 397<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength Manufacturer<br />

6133. Zopiclon 7,5-SL Zopiclonum film-coated tab. 7,5mg N10; N20 Slovakofarma<br />

6134. Zostex Brivudinum tab. 125mg<br />

N1; N7<br />

6135. Zovirax I.V. for Infusion Aciclovirum powder for sol.<br />

for inf.<br />

Berlin-Chemie<br />

250mg/vial N5 Wellcome<br />

6136. Zovirax topical cream Aciclovirum cream 5g/100g 2g tube;10g tube; 2g<br />

tube with pump<br />

6137. Zoxon 1 Doxazosinum tab. 1mg N15;N30 Lečiva<br />

6138. Zoxon 2 Doxazosinum tab. 2mg N10;N30 Lečiva<br />

6139. Zoxon 4 Doxazosinum tab. 4mg N30 Lečiva<br />

6140. Zyban Bupropioni hydrochloridum<br />

(Amfebutamonum)<br />

prolongedrelease<br />

tab.<br />

6141. Zyprexa Olanzapinum coated tab. 5mg<br />

N28<br />

6142. Zyprexa Olanzapinum coated tab. 10mg<br />

N28<br />

6143. Zyprexa Olanzapinum powder for sol.<br />

for inj.<br />

Glaxo<br />

150mg N30;N60 Glaxo Wellcome<br />

10mg/vial<br />

N1<br />

Eli Lilly<br />

Eli Lilly<br />

6144. Zyprexa Olanzapinum coated tab. 2,5mg N28 Eli Lilly<br />

6145. Zyrtec Cetirizini dihydrochloridum film-coated tab. 10mg N3;N7;N10;<br />

N100<br />

6146. Zyrtec Cetirizini dihydrochloridum oral sol. 5mg/5ml<br />

75ml; 200ml<br />

6147. Zyrtec Cetirizini dihydrochloridum oral drops 10mg/ml<br />

20ml<br />

6148. Zyvoxid Linezolidum solution for<br />

infusion<br />

6149. Zyvoxid Linezolidum film-coated<br />

tablets<br />

6150. Zyvoxid Linezolidum film-coated<br />

tablets<br />

6151. Zyvoxid Linezolidum granules for<br />

oral suspension<br />

Eli Lilly/Lilly Pharma<br />

Fertigung<br />

UCB s.a., Secteur<br />

Pharma<br />

UCB s.a., Secteur<br />

Pharma<br />

UCB s.a., Secteur<br />

Pharma<br />

2mg/ml 300ml N10 Manufacture<br />

Assembly (primary<br />

site) QC testing /<br />

Assembly (alternative<br />

site) /Final Release<br />

400mg N10 Manufacture<br />

Assembly (primary<br />

site) QC testing /<br />

Assembly (alternative<br />

site) /Final Release<br />

600mg N10 Manufacture<br />

Assembly (primary<br />

site) QC testing /<br />

Assembly (alternative<br />

site) /Final Release<br />

20mg/ml 150ml after reconstitution<br />

Manufacture<br />

Assembly (primary<br />

site) QC testing /<br />

Assembly (alternative<br />

site) /Final Release


EN<br />

398 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

1. 10 % Kalcio chlorido tirpalas<br />

intravenine˙ms injekcijoms<br />

2. 10-20 % KOFEINO-<br />

NATRIOBENZOATO<br />

TIRPALAS INJEKCIJOMS<br />

3. 5, 10, 25, 40 % Gliukoze˙s<br />

tirpalas injekcijoms<br />

4. A.E. vaccine Nobilis Calnek<br />

1143<br />

B. PHARMACEUTICALS FOR VETERINARY USE<br />

Sol. calcii chloridi pro<br />

injectionibus intravenosus<br />

Sol. Natrii coffeini benzoatis<br />

pro injectionibus<br />

Pharmaceutical<br />

form<br />

Strength<br />

Marketing<br />

authorisation holder<br />

Sol. 10 % Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

Sol. 10-20 %<br />

50 ml<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

Sol. Glucosae pro injectonibus Paste 5 + 10 +25 +40 % Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

Infectious Avian<br />

Encephalomyelitis Vaccine,<br />

Living<br />

Susp. A.E. virus Calnek 1143 >10 3<br />

EID 50,<br />

500 + 1,000 doses<br />

5. ABAMITEl L.A. injection Abamectin Sol. 1 g/100 ml<br />

50+250 ml<br />

6. ABAMITEL plus oral paste Abamectin<br />

Praziquantel<br />

Sol. 0.4 g<br />

5 g/100 ml<br />

30 ml<br />

7. Abortosan E Forte α Tocopherol acetate Susp. 50 mg<br />

100 ml<br />

8. ADE oleosum pro inj. Vitamin A,<br />

Cholecalciferolum,<br />

Tocopheroli acetas<br />

Susp. 300 000 UI,<br />

100 000 UI,<br />

50 mg/ml<br />

100 ml<br />

9. Agtril 10 Norfloxacin Sol. 100 mg<br />

100 + 500 ml + 1 l<br />

10. Alamycin LA, sol. inj. Oxytetracycline dihydrate Sol. 216 mg/ml<br />

50 + 100 ml<br />

11. Albadry Plus susp. Penicilin G Procaine,<br />

Novobiocin sodium<br />

12. Albenas, tablete˙s, granule˙s Albendazole Tabl. et<br />

Gran.<br />

Susp. 200 000 UI,<br />

400 mg<br />

10 ml<br />

300 mg/tabl.,<br />

500 mg/g gran.<br />

10 tabl. or<br />

200 + 500 g gran.<br />

13. Albipen LA susp. inj. Ampicillin Susp. 100 mg/ml<br />

30 + 80 ml<br />

14. Alfacilline 15/15 Procainpenicillin,<br />

Benzatine Penicillin,<br />

Procaine Hydrochloride<br />

Sol. 150 mg,<br />

125 mg,<br />

20 mg<br />

100 ml<br />

15. Alfafer 10 % Iron Sol. 100 mg,<br />

100 ml<br />

16. Alfasan eye ointment Chloramphenicol<br />

Vitamin A<br />

17. Alfatrim 24 % Trimethoprim<br />

Sulfamethoxazole<br />

18. Alfatrim 80/400 Trimethoprim,<br />

Sulphadiazine<br />

Ointm. 20 mg,<br />

15000 IU/g<br />

4g<br />

Sol. 40 mg,<br />

200 mg<br />

100 ml<br />

Tabl. 80 mg,<br />

400 mg<br />

500 + 1000 tabl.<br />

Intervet International<br />

BV<br />

KRKA d.d.<br />

KRKA d.d.<br />

Atarost GmbH & Co.<br />

Veyx-Pharma GmbH<br />

Agrar Holland Al<br />

Soest<br />

Norbrook<br />

Laboratories Ltd.<br />

Pharmacia<br />

Lithuanian<br />

Veterinary Institute<br />

Intervet International<br />

Alfasan International<br />

B. V.<br />

Alfasan International<br />

B. V.<br />

Alfasan International<br />

B. V.<br />

Alfasan International<br />

B. V.<br />

Alfasan International<br />

B. V.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 399<br />

No. Commercial name General name<br />

19. Alfavitacyclin Forte Oxytetracycline,<br />

Vitamin A,<br />

Vitamin D3,<br />

Vitamin E,<br />

Vitamin B1,<br />

Vitamin B2,<br />

Folic Acid,<br />

Vitamin C,<br />

Nicotinacid,<br />

D-panto. acid,<br />

Vitamin K,<br />

Vitamin B12,<br />

Methionine,<br />

Lysine<br />

20. AMOKSIKLAV® 12,5 % water<br />

soluble powder<br />

21. AMOKSIKLAV® 62,5 % water<br />

soluble powder<br />

22. AMOKSIKLAV® tablets<br />

250 mg<br />

Amoxicillin (dosed as<br />

amoxicillin trihydrate)<br />

Clavulanic acid (in the form of<br />

potassium salt)<br />

Amoxicillin (dosed as<br />

amoxicillin trihydrate)<br />

Clavulanic acid (in the form of<br />

potassium salt)<br />

Amoxicillin (dosed as<br />

amoxicillin trihydrate)<br />

Clavulanic acid (in the form of<br />

potassium salt)<br />

Pharmaceutical<br />

form<br />

Strength<br />

Powder 5000 mg,<br />

2500000 IU,<br />

1250000 IU,<br />

250 mg,<br />

120 mg,<br />

200 mg,<br />

10 mg,<br />

1000 mg,<br />

2000 mg,<br />

300 mg,<br />

200 mg,<br />

2 mg,<br />

1000 mg,<br />

1000 mg<br />

100 + 200 + 500 + 1000 g<br />

powder 10.0 g<br />

2.5 g/100 g<br />

100 g<br />

powder 50.0 g<br />

12.5 g/100 g<br />

500 g<br />

tablets 200.0mg<br />

50 mg/850 mg<br />

10 tabl.<br />

23. Amossicillina triidrato 75 % Amoxicillin trihydrate Powder 75 g<br />

100 g<br />

24. Amoxicillin 15% W.S.P. pulv. Amoxicillin trihydrate Powder 150 mg/g<br />

1kg<br />

25. Amoxy-kel 15 % Amoxicillinum anhydricum Sol. 150 mg<br />

50 + 100 + 250 ml<br />

26. Amoxinject 15% susp. Amoxicillin trihydrate Susp. 172,2 mg/ml<br />

50 + 100 ml<br />

27. AMOXITAB 40, AMOXITAB<br />

200<br />

Amoxicillin trihydrate Tabl 45.92 mg or 230.0 mg/tabl.<br />

100 tabl<br />

28. AMOXIVAL 20 Amoxicillin (as trihydrate) powder 20.0 g/100 g<br />

100g+1+5 kg<br />

29. Ampicillin Trihydrate 20%<br />

susp., pro inj.<br />

30. AMPICLOX LC Sodium cloxacillin, equivalent<br />

to cloxacillin<br />

Sodium ampicillin, equivalent<br />

to ampicillin<br />

Ampicillin trihydrate Susp. 200 mg/ml<br />

100 ml<br />

Susp. 200 mg<br />

75 mg/3 g<br />

3 g syr.<br />

31. Ampisan 20 susp. pro inj. Ampicillini trihydras Susp. 200 mg/ml<br />

100 ml<br />

32. AMPITAB 180 mg (Ampitab<br />

forte)<br />

33. AMPITAB 50 mg (Ampitab<br />

mite)<br />

34. AMPITAB suspension<br />

(Ampitab oral drops)<br />

Marketing<br />

authorisation holder<br />

Alfasan International<br />

B. V.<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d. d.<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d. d.<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d. d.<br />

Farmaceutici Gellini<br />

S.P.A.<br />

Dopharma B.V.<br />

Kela Laboratoria<br />

Bremer Pharma<br />

GmbH<br />

Bremer Pharma<br />

GmbH<br />

Laboratoires Sogeval<br />

Bremer Pharma<br />

GmbH<br />

Pfizer Oy Animal<br />

Health<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Ampicillin trihydrate Tabl. 207.90 mg/tabl. CHASSOT AG<br />

Ampicillin trihydrate Tabl. 57.75 mg/tabl. CHASSOT AG<br />

Ampicillin trihydrate Susp. 438.8 mg/tabl. CHASSOT AG<br />

35. AMPROLIUM 25 % Amprolium HCl Sol. 250 g/l<br />

100+200+1000 ml+ 5+10 l<br />

Chemifarma S.p.A.


EN<br />

400 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

36. AMURIL® 10 % Amoxicillin (in the form of<br />

trihydrate)<br />

37. ANPROCICLINA 200 —<br />

premix<br />

38. Antastmon Trimehoprim,<br />

Sulphadiazin<br />

39. Antitox Natriumthiosulphat<br />

pentahydrat,<br />

Natrium L-Glutamat,<br />

Natriumdisulfit<br />

Pharmaceutical<br />

form<br />

powder 10.0 g/100 g<br />

100+ 1000 g<br />

Oxytetracycline Powder 200 g<br />

10 + 25 kg<br />

Powder 10 g,<br />

50 g<br />

1+5+25kg<br />

Strength<br />

Sol. 199.3 mg,<br />

22.13 mg,<br />

0.5 mg<br />

100 + 250 + 500 ml<br />

Marketing<br />

authorisation holder<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d.d.<br />

Chemifarma S.p.A.<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Alvetra GmbH<br />

40. Apistan Tau — Fluvalinate Strips 10 strips Sandoz SGS<br />

41. Apralan, Apralan G — 100<br />

Premix, Apralan Solubile,<br />

Apralan 200 inj.<br />

Apramycin sulfate Sol.<br />

Powder<br />

200 mg/ml<br />

50 + 100 +150 ml<br />

100 g/kg<br />

5+25kg<br />

42. APRAMYCIN INJECTABLE Apramycin Sol. 200 mg/ml<br />

30+50 ml<br />

43. APRAMYCIN PULVIS Apramycin powder 50 g/100 g;<br />

50+100 g<br />

44. AUBIKAL 2- Carbamoylphenoxyacid<br />

sodium,<br />

Hydroxybenzo acide<br />

methylester sodium<br />

45. AUREOSULFAN Chlortetracycline chlorhydrate,<br />

Sulfanilamide<br />

Susp. 20 g,<br />

0.065 g/100 ml<br />

Susp. 3 g,<br />

45 g<br />

Elanco Animal<br />

Health, Eli Lilly<br />

Gmbh<br />

Balkanpharma-<br />

Razgrad AD<br />

Balkanpharma-<br />

Razgrad AD<br />

ATAROST GmbH &<br />

Co.<br />

SOGEVAL<br />

46. AUROFAC 100 Chlortetracycline HCl Powder 100 g/kg Alpharma AS<br />

47. Aversekt — 2 (Farmacin) Aversektin C Sol. 1%<br />

1 + 10 + 100 + 250 + 450 ml<br />

48. Avinew Newcastle Disease Vaccine,<br />

Living<br />

Vac. liof. Newcastle virus >10 6 EID 50,<br />

1,000 doses<br />

Scientific Industrial<br />

Union ‘Farmbiomed’<br />

Rhone Merieux<br />

49. Bayvarol Permethrin Strips 3,6 mg/per strip Bayer AG<br />

50. BARVAC® RS, Bovine respiratory Syncytial<br />

virus (Tennessee strain) min.<br />

1.58×10 6 TCID 50<br />

Susp. 1.52 ml/2 ml<br />

10+50 dosis<br />

51. Bela — Fer — Dextran 100 Iron dextran Iron 100 mg,<br />

Dextran 200 mg<br />

52. Belamisol 10, sol. inj. Levamisol hydrochlorid Sol. 118 mg/ml<br />

100 + 250 ml<br />

53. Bela-Multivit pro inj. Vitaminum A,<br />

Vitaminum D 3,<br />

Vitaminum E,<br />

Vitaminum B 1,<br />

Vitaminum B 2,<br />

Vitaminum B 6,<br />

Vitaminum B 12,<br />

Calcii pantothenas,<br />

Nicotinamidum,<br />

Extractum hepatis<br />

54. Belcospira oral pulv. Colistini sulfas,<br />

Spiramycinum<br />

Sol. 5,385 mg,<br />

0,1875 mg,<br />

20 mg,<br />

10 mg,<br />

6,84 mg,<br />

3 mg,<br />

0,12 mg,<br />

25 mg,<br />

35 mg,<br />

25 mg/ml<br />

100 + 500 ml<br />

Powder 50 mln. UI/100 g,<br />

65 mln. UI/100 g<br />

100 g<br />

Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Rhone Merieux


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 401<br />

No. Commercial name General name<br />

55. Benestermycin Dry Cow Penethamathydrojodid,<br />

Benethamin-Penicillin,<br />

Framycetin sulfat<br />

Pharmaceutical<br />

form<br />

Susp. 100 mg,<br />

280 mg,<br />

100 mg<br />

5ml<br />

56. Betamox LA, susp. Amoxicillin trihydrate Susp. 150 mg/ml<br />

50 + 100 ml<br />

57. Bigopest Newcastle Disease, Infectious<br />

Bursal Disease and Avian<br />

Infectious Bronchitis Vaccine,<br />

Inactivated<br />

58. Bimavite plus Thiamine hydrochloride,<br />

Riboflavine,<br />

Nicotinamide<br />

Pyridoxine hydrochloride,<br />

Ascorbic acid<br />

Strength<br />

Susp. Infectious Bronchitis virus<br />

>10 6.7 EID 50, Infectious Bursal<br />

disease virus >10 5.7 CCID 50,<br />

Inactivated Newcastle disease<br />

virus >10 8 EID 50,<br />

1500 + 1000 doses<br />

Sol. 35 mg,<br />

0.8 mg,<br />

22.5 mg,<br />

7 mg,<br />

70 mg<br />

5 + 100 ml<br />

59. Bimoxyl LA Amoxycillin Sol. 150 mg<br />

100 ml<br />

60. Binewvaxidrop vaccine pro inj. Avian Infectious Bronchitis,<br />

Newcastle Disease and Eggdrop<br />

Syndrome Vaccine,<br />

Inactivated<br />

61. Bio HVT (Lyo) Marek's Disease Vaccine,<br />

Living<br />

Susp. Infectious Bronchitis virus<br />

10 6.7 EID 50,<br />

Newcastle Disease virus 10 8<br />

EID 50,<br />

Adenovirus 10 6 EID 50,<br />

500 + 1,000 doses<br />

Lyoph. vac. Turkey Herpes virus >3000<br />

PF/dose<br />

1000 doses<br />

62. BIO KILL spray Technical permethrin (25:75) Sol. 0,25 %;<br />

100+200+300+500+1000+<br />

5000 ml<br />

63. BIO REO 1. Avian viral arthritis reovirus,<br />

strain S 1133<br />

64. BIOCAN DHPPI inj. sicc. ad us.<br />

vet.<br />

65. BIOCAN LR INJ. AD US. VET.,<br />

BIOCAN L INJ. AD US. VET.,<br />

BIOCAN R inj. ad us. vet.<br />

66. BIOCOM®-DP, BIOCOM®-P,<br />

DISTEMINK®<br />

Attenuated viruses of canine<br />

distemper (CDV<br />

canine infectious<br />

laryngotracheitis (CAV-2)<br />

canine parvovirosis (CPV-2)<br />

canine parainfluenza (CPIV-2<br />

Inactivated virus rabies<br />

Inactivated culture of<br />

Leptospira icterohaemorrhagia<br />

Inactivated culture of<br />

Leptospira canicola<br />

Mink enteritis virus type 1<br />

Mink enteritis virus type 2<br />

Clostridium botulinum type C<br />

bacterin toxoid<br />

Pseudomonas aeruginosa<br />

serotypes 5, 6 and 7-8<br />

Freeze dried<br />

vac.<br />

‡10 4 CCID 50<br />

1000 doses<br />

Liof. ‡10 3 TCID 50<br />

‡4×10 3 TCID 50<br />

‡10 4.5 TCID 50<br />

‡10 3 TCID 50;<br />

1 dose<br />

Susp. ‡1 IU<br />

‡4×10 7.0<br />

‡4×10 7.0<br />

1 dose<br />

Susp. ‡5120 HA units/ml<br />

‡5120 HA units/ml<br />

‡10 5.2 mouse LD 50/ml<br />

2.0 mg per serotype<br />

100+250 doses<br />

67. BIOKETAN Ketamine hydrochloride Sol. 115,34 mg/ml<br />

10 + 20 + 50 ml<br />

68. Bioral H — 120 Infectious Bronchitis Vaccine Freeze dried<br />

vac.<br />

69. BIOSEPTONEX Carbentopendecinium bromide Sol. 1 g/100 ml<br />

100 ml<br />

Infectious bronchitis virus<br />

>10 3 EID 50<br />

1000 + 5000 doses<br />

Marketing<br />

authorisation holder<br />

Leo Pharmaceutical<br />

Products Ltd.<br />

Norbrook<br />

Laboratories Ltd.<br />

Merial<br />

Bimeda Chemicals<br />

export<br />

Bimeda Chemicals<br />

export<br />

Rhone Merieux<br />

MERIAL ITALIA<br />

Bioveta Plc.<br />

Merial Italia S.p.A<br />

Bioveta Plc.<br />

Bioveta Plc.<br />

United Vaccines, Inc.<br />

Zakłady<br />

Farmaceutyczne<br />

‘Biowet’ Sp. z o.o.<br />

Merial<br />

Bioveta Plc.


EN<br />

402 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

70. Biosol 70% pulv. Neomycini sulfas Powder 700 mg/g<br />

1kg<br />

Strength<br />

Marketing<br />

authorisation holder<br />

Pharmacia<br />

71. Biovit NV-40-180 Chlortetracycline, Vit. B 12 Powder 1 + 3 + 5 + 10 + 15 + 20 kg JSC Biovetfarm<br />

72. Bipestos Newcastle Disease and Avian<br />

Infectious Bronchitis Vaccine<br />

73. Bivatop 200 Oxytetracycline,<br />

Magnesium oxyde<br />

74. BOLFO® FLEA COLLAR FOR<br />

CATS AND SMALL DOGS;<br />

BOLFO® FLEA COLLAR FOR<br />

(LARGE) DOGS<br />

2-Isopropoxyphenyl -Nmethylcarbamate<br />

Di-n-butyl adipate<br />

Diethylhexyl phthalate<br />

75. BOLFO® FLEA POWDER 2-Isopropoxyphenyl -Nmethylcarbamate<br />

Magnesium stearate<br />

76. BOLFO® FLEA SHAMPOO 2-Isopropoxyphenyl -Nmethylcarbamate<br />

Triethanolamine alkyl<br />

benzenesulphonate<br />

Sodium alkyl<br />

benzenesulphonate<br />

77. BOLFO® FLEA SPRAY 2-Isopropoxyphenyl -Nmethylcarbamate<br />

Fresh aromatic essence<br />

760712<br />

78. BOVACLOX DC Cloxacillin benzathine,<br />

Ampicillin trihydrate<br />

79. BOVIESTIMUL Dried ruminal flora<br />

D,L-methionine<br />

L-lysine<br />

Cobalt sulfate<br />

Ammonium sulfate<br />

80. BOVIESTIMUL Dexamethasone (21isonicotinate)<br />

81. BOVIKETAS Mollase<br />

Water<br />

propylenglycol<br />

82. BUR-706 pulv. Infectious Bursal Disease<br />

Vaccine<br />

83. BUR-CELL S-706+HVT Bursal disease virus, S-706<br />

strain<br />

Marek's disease virus, FC-126<br />

strain<br />

84. BURSINE®-2, Infectious Bursal Disease Virus<br />

Strain Lukert<br />

85. BUSCOPAN COMPOSITUM<br />

.<br />

Butylscopalaminium bromide<br />

Metamizole sodium<br />

Newcastle disease virus >10 6<br />

EID 50, Infectious Bronchitis<br />

>10 3 EID 50<br />

1000 doses<br />

Sol. 215.7 mg,<br />

17 mg<br />

100 + 250 + 500 ml<br />

Collar 9.87 %<br />

21.10 %<br />

9.10 %<br />

Powder g<br />

0.05 g/100 g<br />

100 g<br />

Sol. 0.122 g<br />

44,360 g<br />

11.090 g/100 ml<br />

100 ml.<br />

Aeros. 0.2500 g<br />

0.1000 g/100 g<br />

250 ml<br />

Ointm. 500 mg,<br />

250 mg/4,5 g<br />

4,5 g<br />

powder 20 mg<br />

30 mg<br />

5mg<br />

5mg<br />

50 mg/g<br />

0.5+1+5+25 kg<br />

Sol. 1 mg/ml<br />

10+50 ml<br />

Sol. 75 %<br />

14.739 %<br />

10 %<br />

0.5+1+3+5+10 l<br />

Susp. Virus S706> 10 4 CPD 50/doses<br />

1 000 + 5 000 + 10 000 +<br />

15 000 + 20 000 doses<br />

Freeze dried vc. ‡10 2.1 TCID 50<br />

‡1 418 PFU<br />

1000 doses<br />

Lyoph. vac. at least 10 4,3 TCID 50<br />

100+2500+ 500+10000 doses<br />

Sol. 400 mg<br />

50,00 g/100 ml<br />

100 ml<br />

Merial<br />

Boehringer<br />

Ingelheim<br />

Bayer AG, Animal<br />

Health Division<br />

Bayer AG, Animal<br />

Health Division<br />

Bayer AG, Animal<br />

Health Division<br />

Bayer AG, Animal<br />

Health Division<br />

NORBROOK<br />

Laboratories Limited<br />

Industrial<br />

Veterinaria, S.A. —<br />

Invesa<br />

Industrial<br />

Veterinaria, S.A. —<br />

Invesa,<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

Rhone Merieux<br />

Merial Select Inc.<br />

Fort Dodge Animal<br />

Health<br />

Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

86. BUTOX 50, Deltamethrine Sol. 50 g/l Hoechst Roussel Vet<br />

GmbH


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 403<br />

No. Commercial name General name<br />

87. Calcigluc Calcium gluconate,<br />

Magnesium gluconate,<br />

Calcium chloride,<br />

Magnesium chloride<br />

Boric acid<br />

88. CALCII BOROGLUCONAS<br />

25 %<br />

Calcii gluconas,<br />

Acidum boricum<br />

89. Calcii et magnesii pro inj. Calcii gluconas,<br />

Magnesii adipatas<br />

90. Calciject 40 CM Calcium borogluconate,<br />

Magnesium<br />

hypophosphitehexahydrate<br />

91. Calciject PMD Calcium borogluconate,<br />

Magnesium hypophosphite<br />

92. Calci-kel 300. Calcium gluconate,<br />

Boric acid,<br />

Magnesium chloride,<br />

Coffeine monohydrate,<br />

Ephedrine hydrochloride<br />

93. Calcium borogluconat Calcium gluconat,<br />

Acidum boricum,<br />

Magnesium chlorid<br />

94. Calcium gluconat 38% cum<br />

phosphor, pro inj.<br />

Calcium gliukonat<br />

Phosphorus D 2<br />

Pharmaceutical<br />

form<br />

Sol. 6 g,<br />

2.7 g,<br />

2.7 g,<br />

3g,<br />

1.5 g<br />

Sol. 21.66 g,<br />

3 g/100 ml<br />

250 ml<br />

Sol. 200 g/l,<br />

40 g/l<br />

500 ml<br />

Sol. 40 %,<br />

5%.<br />

400 ml<br />

Sol. 20 %,<br />

5%.<br />

400 ml<br />

Sol. 279,24 mg,<br />

76,84 mg,<br />

40 mg,<br />

0,8 mg,<br />

0,2 mg/ml<br />

500 ml<br />

Sol. 380 mg,<br />

50 mg,<br />

60 ml<br />

500 ml<br />

Strength<br />

Sol. 38,0 g/100 ml<br />

0,2 g/100 ml<br />

500 ml + 1 000 ml<br />

95. CALCORAL FORTE GEL Calcium chloride dihydrate Gel 196.0 g/400 ml<br />

400 ml<br />

96. Calem Anhydrous calcium chloride Sol. 139 g<br />

445 ml<br />

97. CALFOSTONIC Vitamin A,<br />

Vitamin D 3,<br />

Vitamin B 1,<br />

Vitamin B 2,<br />

Vitamin B 6,<br />

Vitamin B 12,<br />

Vitamin E,<br />

Vitamin K 3,<br />

Calcium pantothenate,<br />

Nicotinamde,<br />

Choline chloride,<br />

L-methionine,<br />

L-lisine<br />

98. CANIGEN®<br />

DH( A2)PPI /LR<br />

Attenuated Canine distemper<br />

virus (Lederle strain)<br />

Attenuated Canine adenovirus<br />

type 2 (Manhattan strain)<br />

Attenuated Canine parvovirus<br />

(CPV780916 strain)<br />

Attenuated Canine<br />

parainfluenza virus (Manhattan<br />

strain)<br />

Leptospira canicola<br />

Leptospira<br />

icterohaemorrhagiae<br />

Rabies virus inactivated (VP12<br />

strain)<br />

Powder 600 000 IU;<br />

200 000 IU;<br />

100 mg;<br />

200 mg;<br />

10 mg;<br />

1.1 mg;<br />

75 mg;<br />

25 mg;<br />

1.25 g;<br />

500 mg;<br />

25 g;<br />

10 g;<br />

2.5 g/1 kg<br />

Liof+susp. 10 3 -10 5 TCID 50<br />

10 4 -10 6 TCID 50<br />

10 5 -10 7 TCID 50<br />

10 5 -10 7 TCID 50<br />

‡833·10 6 bact./ml<br />

‡833·10 6 bact./ml<br />

‡1 IU/dose<br />

1 dose<br />

Marketing<br />

authorisation holder<br />

Bioveterinary Works<br />

BIOVET<br />

BIOVETERINARY<br />

WORKS ‘BIOWET’<br />

Serum-Werk<br />

Bernburg AG<br />

Norbrook<br />

Laboratories Limited<br />

Norbrook<br />

Laboratories Limited<br />

Kela Laboratoria<br />

CP-Pharma Burgdorf<br />

Atarost GmbH<br />

C. Richter GesmbH<br />

&CoKG<br />

Bioveterinary Works<br />

BIOVET<br />

Invesa International,<br />

S.A.<br />

Virbac S.A.


EN<br />

404 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

99. CANIGEN® DH( A2)PPI/L Attenuated Canine distemper<br />

virus (Lederle strain)<br />

Attenuated Canine adenovirus<br />

type 2 (Manhattan strain)<br />

Attenuated Canine parvovirus<br />

(CPV780916 strain)<br />

Attenuated Canine<br />

parainfluenza virus (Manhattan<br />

strain)<br />

Leptospira canicola<br />

Leptospira<br />

icterohaemorrhagiae<br />

100. C-B-Gluconat-Lösung 30 % pro<br />

inj.<br />

Calcii gluconas,<br />

Acidum boricum<br />

Pharmaceutical<br />

form<br />

Strength<br />

Liof+susp. 10 3 -10 5 TCID 50<br />

10 4 -10 6 TCID 50<br />

10 5 -10 7 TCID 50<br />

10 5 -10 7 TCID 50<br />

‡833·10 6 bact./ml<br />

‡833·10 6 bact./ml<br />

1 dose<br />

Sol. 24 g,<br />

6 g/100 ml<br />

500 ml<br />

101. Cefa-cure, tabl. Cefadroxilum 506 2006 1,000 mg/tabl.<br />

10 tabl.<br />

102. CEFA-DRI Cephapirin benzathine Susp. 300 mg/10 ml<br />

10 ml<br />

103. CEFA-LAK Cephapirin sodium Susp. 200 mg/10 ml<br />

10 ml<br />

104. Cefa-Safe pro inj. Cephapirin benzathine,<br />

Arachis oil,<br />

Aliuminium stearate<br />

105. CEFASEPTIN 120 (VETICEF<br />

120)-CEFASEPTIN 600<br />

(VETICEF 600)<br />

106. CEJAKOL Potassium jodid,<br />

Guaifenesin,<br />

Metamizol — Sodium<br />

107. CERTISELEN E liquid Vitamin E (α-tocopherol<br />

acetate)<br />

Sodium selenite<br />

108. CEVAC BI L Lentogenic, Hitchner B1 strain<br />

of Newcastle disease virus<br />

(NDV)<br />

Massachusetts type of<br />

bronchitis virus, B48 strain<br />

109. CEVAC BRON 120L Infectious bronchitis virus<br />

(IBV) H-120 strain<br />

(Massachusetts serotype<br />

110. CEVAC GUMBO L Infectious bursal disease virus<br />

LIBDV strain<br />

111. CEVAC IBD L Infectious bursal disease virus<br />

2512, G-61 strain<br />

112. CEVAC MASS L Infectious bronchitis virus,<br />

Massachusetts type, strain B-48<br />

113. CEVAC ND-IB K Inactivated Newcastle disease<br />

virus strain ‘SZ’ (NDV-SZ<br />

LaSota)<br />

Inactivated infectious<br />

bronchitis virus strain ‘M-41’<br />

114. CEVAC UNI L Lentogenic, Hitchner B1 strain,<br />

Newcastle disease virus (NDV)<br />

115. CEVAC VITAPEST L Newcastle disease virus,<br />

apathogenic PHY.LMV.42<br />

strain<br />

Susp. 383,3 mg/10 ml,<br />

8,59 g/10 ml,<br />

259 mg/10 ml<br />

10 ml<br />

Cephalexin monohydrat Tabl. 126.22-631.11 mg/tabl.<br />

10 tabl.<br />

Susp. 2.4 g,<br />

1g,<br />

0.1 g/100 ml<br />

Sol. 10 g<br />

50 mg/100 ml<br />

1+5 l<br />

Liof. ‡10 5.5 EID 50<br />

‡10 2.63 EID 50<br />

1000+2500 doses<br />

Liof. ‡10 3.5 EID 50<br />

100+2500 doses<br />

liof ‡10 3.0 TCID 50<br />

500+1000+2500 doses<br />

Liof. ‡10 2.0 EID 50<br />

100+2500 doses<br />

Liof. ‡10 2.63 EID 50<br />

1000+2500 doses<br />

Sol. ‡10 9.0 EID 50<br />

‡10 8.0 EID 50<br />

500 ml<br />

Liof. ‡10 5.5 EID 50<br />

100+2500 doses<br />

Liof. ‡10 5.5 EID 50<br />

1000+2000+2500 doses<br />

Marketing<br />

authorisation holder<br />

Virbac S.A.<br />

Bela — Pharm<br />

GmbH Co.<br />

Intervet International<br />

Fort Dodge Animal<br />

Health<br />

Fort Dodge Animal<br />

Health<br />

Intervet Interanation<br />

CHASSOT AG<br />

ATAROST GmbH &<br />

Co.<br />

Laboratoires<br />

SOGEVAL<br />

Ceva Sante Animale<br />

Ceva Sante Animale<br />

Ceva Sante Animale<br />

Ceva Sante Animale<br />

Ceva Sante Animale<br />

Ceva Sante Animale<br />

Ceva Sante Animale<br />

Ceva Sante Animale


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 405<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength<br />

116. CEVAMEC 1 % Ivermectin Sol. 1 g/100 ml<br />

50+100+250+500 ml<br />

117. CHICKTONIC Vitamin A<br />

Vitamin D 3<br />

Vitamin E<br />

Vitamin K 3<br />

Pyridoxine<br />

Riboflavine<br />

Thiamine<br />

Dexpanthenol<br />

Vitamin B 12<br />

Methionine<br />

Choline<br />

Lysine<br />

Histidine<br />

Arginine<br />

Aspartic acid<br />

Threonine<br />

Serine<br />

Glutamic acid<br />

Proline<br />

Glycine<br />

Sol. 500 000 I.U<br />

500 000 I.U<br />

3.75 g<br />

250 mg<br />

2g<br />

4g<br />

3.5 g<br />

15 g<br />

10 mg<br />

5g<br />

400 mg<br />

2.5 g<br />

900 mg<br />

490 mg<br />

1.45 g<br />

500 mg<br />

680 mg<br />

1.16 g<br />

510 mg<br />

575 mg<br />

100+250+500+1000+5000+<br />

6000 ml<br />

118. Chorulon pro inj. Gonadotropini chorionicum Sol. 500 AU-1,000 AU/ml<br />

1,500 ir 5,000 IU<br />

119. CYCLIVAL 200 L.A. Oxytetracycline Sol. 20.0 g/100 ml<br />

50+100+250+500 ml<br />

120. Cydectin 1 % pro inj. Moxydectine Sol. 1 %<br />

50 + 200 + 500 ml<br />

121. CYFAC HS GRANULAR Chlortetracycline<br />

hydrochloride,<br />

Sulphamidine<br />

Procaine penicillin<br />

122. CLAMOXYL L.A. INJECTION Amoxycillin (as amoxycillin<br />

trihydrate)<br />

Gan. 73,2 g,<br />

73,2 g,<br />

36,6 g/kg<br />

Susp. 15 %<br />

100+250 ml<br />

123. Clamoxyl pulv. Amoxicillin trihydrate Powder 50g/98 g<br />

98 g<br />

124. Clinacox 0,5% pulv. Diclazuril Powder 5 mg/g<br />

10 kg<br />

125. Clortadona TS, pulv. Erythromycin estolate,<br />

Sulfamidin sodium<br />

Trimethoprim,<br />

Neomycin sulfate,<br />

Bromhexine hydrochloride<br />

126. Cloxamast Ampicillin,<br />

Cloxacillin<br />

127. CLOXIN TS INJECTOR® Cloxacillin sodium<br />

Neomycin sulphate<br />

128. COBAPHOS Oxybenzylphosphinic acid<br />

Cyanocobalamine<br />

129. Coffeinum Natrii benzoas pro<br />

inj.<br />

130. COLIFARM 20 — water<br />

soluble powder<br />

Coffeine,<br />

Sodium benzoate<br />

Powder 25 mg/g,<br />

100 mg/g,<br />

18 mg/g,<br />

35 mg/g,<br />

1,5 mg/g<br />

Susp. 75 mg,<br />

200 mg<br />

4.5 g<br />

Susp. 416.67 mg<br />

416.67 mg/10 ml<br />

10 ml<br />

Sol 125 mg<br />

0.05 mg<br />

100 ml<br />

Sol. 8 g/100 ml,<br />

12 g/100 ml<br />

10 + 20 + 50 ml<br />

Flumequine Powder 200 g<br />

0,1 + 1,0 + 5,0 + 10 kg<br />

Marketing<br />

authorisation holder<br />

CEVA PXYLAXIA<br />

SANTE ANIMALE<br />

Invesa International,<br />

S.A.<br />

Intervet International<br />

Laboratoires Sogeval<br />

Cyanamid-Animal<br />

Health<br />

Alpharma AS<br />

Pfizer Italian S. p. A.<br />

Smith Kline<br />

Beecham<br />

Janssen<br />

Pharmaceutica N.V.<br />

Laboratorios Hipra<br />

Bimeda Chemicals<br />

export<br />

Veyx-Pharma GmbH<br />

C. Richter GesmbH<br />

&CoKG<br />

Biowet-Pulawy<br />

Chemifarma S.p.A.


EN<br />

406 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

131. Colipen Veyx susp. inj. Colistin sulfat,<br />

Procain Penicilin G<br />

132. Colipra Jet, sol. Gentamicin sulfate,<br />

Sulfadimidine bis etan sodium<br />

sulfonate,<br />

Trimethoprim<br />

133. COLIPRIM SOLUTION 10 % Sodium Sulfachloropyridazine<br />

Trimethoprim<br />

Pharmaceutical<br />

form<br />

Susp. 11,1 mg,<br />

200 000 UI/ml<br />

100 ml<br />

Strength<br />

Sol. 15 mg/ml,<br />

18 mg/ml,<br />

3 mg/ml<br />

200 + 1,000 ml<br />

Sol. 104.0 mg<br />

20.0 mg/ml<br />

500+1000 ml<br />

134. Colistin 12 % Colistin sulfat Powder 12 g/100 g<br />

100g+1+25kg<br />

135. COLISTIN SULFATE(ANIMAL<br />

USE), COLISTIN SULFATE<br />

(FEED GRADE-R), COLISTIN<br />

2 % MEIJI, COLISTIN 2 % FINE<br />

GRANULES MEIJI %,<br />

COLISTIN 10 % MEIJI<br />

Coistin sulphat Gran. et<br />

Powder<br />

136. Colivet Colistin Powder 120000000 IU<br />

1+5+20kg<br />

137. COLVASONE Dexamethasone sodium<br />

phosphate,<br />

Sodium dihydrogen phosphate,<br />

Disodium hydrogen phosphate<br />

138. Combi-kel 40 Procaine benzylpenicillin<br />

lecitin coated,<br />

Dihydrostreptomycin sulfate<br />

139. COMBIVIT Vitamin B1,<br />

Vitamin B2,<br />

Vitamin B6,<br />

Nicotinamide,<br />

Ascorbic acid<br />

Sol. 2 mg,<br />

1 mg,<br />

21.5 mg/ml<br />

50 + 100 ml<br />

Marketing<br />

authorisation holder<br />

Veyx-Pharma GmbH<br />

Laboratorios Hipra<br />

Abic Ltd.<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

20-100 g/kg MEIJI SEIKA<br />

KAISHA, LTD.<br />

Sol. 200 mg,<br />

200 mg/ml<br />

30 + 50 + 100 + 250 ml<br />

Sol. 35.0 mg;<br />

0.5 mg;<br />

7.0,<br />

23.0 mg;<br />

70.0 mg/ml;<br />

50 + 100 ml<br />

140. COVINAN® Proligestone Sol. 100 mg/ml<br />

20 ml<br />

141. Crestar pro inj. Estradiol valerate Sol. 2,5 mg/ml<br />

2ml<br />

142. DECTOMAX® Doramectin Sol. 10.00 mg/ml<br />

25+50+200+500 ml<br />

143. DEFENSOR® 3 Rabies virus Susp. ‡10 7.25 TCID 50<br />

1 dose<br />

144. Dehelman pro inj. Levamisoli hydrochloridum Sol. 10 g/100 ml<br />

100 ml<br />

145. Dehelman pulv. Levamisoli hydrochloridum Powder 11,8 g/100 g<br />

20 g + 100 g + 1 kg<br />

146. Depedin Veyx susp. inj. Prednisolon acetat,<br />

Dexamethason<br />

Susp. 7,5 mg,<br />

2,5 mg/ml<br />

50 ml<br />

147. Depo — Promone Medroxyprogesteroni acetate Susp. 50 mg/ml<br />

1-5 m<br />

148. DEVOMYCIN INJECTION Streptomycin sulfate Sol. 200,000 units/ml<br />

50 + 100 ml<br />

149. Dewo pro inj. Levamisole hydrochloride Sol. 117,9 mg/ml<br />

25 + 100 ml<br />

Ceva Sante Animale<br />

NORBROOK<br />

Laboratories Limited<br />

Kela Laboratoria<br />

NORBROOK<br />

Laboratories Limited<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

Pfizer S.A.<br />

Pfizer Oy Animal<br />

Health<br />

KRKA<br />

KRKA<br />

Veyx-Pharma GmbH<br />

Pharmacia<br />

NORBROOK<br />

Laboratories Limited<br />

Bremer Pharma<br />

GmbH


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 407<br />

No. Commercial name General name<br />

150. Dexamethasone 2 mg/ml Dexamethasone Sodium<br />

Phosphate<br />

151. DIGICOFFIN N Coffein,<br />

Sodum salicylat<br />

152. Diminasan 5 % Diminazene diaceturate,<br />

Antipyrine<br />

Pharmaceutical<br />

form<br />

Strength<br />

Marketing<br />

authorisation holder<br />

Sol. 100 ml Alfasan International<br />

B. V.<br />

Sol. 18 g,<br />

27 g/ml<br />

Sol. 50 mg,<br />

350 mg<br />

50 + 100 ml<br />

153. DINOLYTIC Dinoprost tromethamine Sol. 5 mg/ml<br />

10+30+100 ml<br />

154. Dipen forte, susp. inj. Procain Penicillin,<br />

Dihydrostreptomycin<br />

155. DITRIVET 120,<br />

DITRIVET 480<br />

Trimethoprim<br />

Sulphadiazine<br />

Susp. 200 mg/ml,<br />

250 mg/ml<br />

tabl 20 or 80 mg<br />

100 or 400 mg<br />

100 tabl.<br />

156. Divakonas, tirp. Dimephosphon Sol. 15 %<br />

45,9 + 135 g<br />

157. Dizevak — C, 1 ml. Clostridium Perfringens<br />

Vaccine<br />

Susp. Anatoxin of Clostridium<br />

perfringens 45-50 %/ml<br />

50 + 100 + 250 + 5000 ml<br />

1ml<br />

ATAROST GmbH &<br />

Co.<br />

Alfasan International<br />

B. V.<br />

Pharmacia<br />

Bimeda Chemicals<br />

export<br />

Pabianickie Zakłady<br />

Farmaceutyczne<br />

Polfa<br />

JSC A. Bloznelio<br />

‘Comercial<br />

enterprise’,<br />

PLIVA d. d. B.V.<br />

158. Docatel tabl. Praziquantel Tabl. 50 mg Bremer Pharma<br />

GmbH<br />

159. Doxycycline hyclate 20%, pulv. Doxycycline hyclate Powder 200 mg/g<br />

1kg<br />

160. DOXYSEPTIN 100,<br />

DOXYSEPTIN 300<br />

Doxycycline Tabl. 100.0-300.0 mg/tabl.<br />

10 + 20 + 100 + 500 tabl.<br />

161. Drycloxa-kel Cloxacillin benzathine Susp. 1 g<br />

9g<br />

162. Drinkmix Colistin, pulv. Colistin sulfate Powder 5 000 000 UI<br />

1kg<br />

163. DRONTAL® PLUS Febantel<br />

Pyrantel Pamoate<br />

Praziquantel<br />

164. DUOWIN CONTACT Permethrin<br />

Pyriproxyfen<br />

165. Duplocillin pro inj. Benzathine benzylpenicillin,<br />

Procaine benzylpenicillin<br />

166. DURAMUNE DA 2LP+P V Canine distemper, adenovirus,<br />

parainfluenza, parvovirus,<br />

coronavirus, Leptospira<br />

vaccine<br />

Tab. 150 mg<br />

144.0 mg<br />

50.0 mg/tabl.<br />

2+6+20 tabl.<br />

Sol. 400 mg<br />

3 mg/ml<br />

2+4+8 ml<br />

Susp. 114,6 mg/ml,<br />

148,4 mg/ml<br />

30 + 50 + 100 + 250 ml<br />

Susp. Canine distemper virus 0.4 ml,<br />

Canine adenovirus 0.0018 ml,<br />

Canine parainfluenza virus<br />

0.241 ml, Canine parvovirus-0.1062<br />

ml, Inactivated<br />

canine coronavirus-0.0333 ml,<br />

Inactivated Leptospira canicola-0.119<br />

ml, Inactivated<br />

Leptospira icterohaemorrhagiae-0.119<br />

ml/dose<br />

1+3ml<br />

Dopharma B.V.<br />

CHASSOT AG<br />

Kela Laboratoria<br />

Dopharma B.V.<br />

Bayer AG, Animal<br />

Health Division<br />

Virbac S.A.<br />

Intervet International<br />

Fort Dodge Animal<br />

Health


EN<br />

408 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength<br />

167. Ecofleece Cypermetrin Emuls. 10 %<br />

1+20+25ml+1l<br />

168. ECZEKAN SUGAR Dexamethasone,<br />

Nicotinamide,<br />

Pyridoxine hydrochloride,<br />

Methionine<br />

Pieces 1 mg,<br />

10 mg,<br />

50 mg,<br />

300 mg/8 g<br />

8 pieces<br />

169. EGOCIN 20 % POWDER Oxytetracycline chloride powder 20.0 g/100 g<br />

100+1000g+ 25 kg<br />

170. EGOCIN L.A. INJECTION Oxytetracycline chloride Sol. 20.0 g/100 ml<br />

50+100 ml<br />

171. Eisen B 12 Komplex 100 Iron dextran<br />

Cyanocobalamin<br />

Sodium chloride<br />

Sol. 301.4 mg<br />

0.01 mg,<br />

10 mg<br />

100 + 500 ml<br />

172. Eisendextran injectionslosung Iron dextran Sol. 100 mg<br />

100 ml<br />

173. Eisendextran+vitamin Iron dextran,<br />

Vit.A-palmitat,<br />

Cholecalciferol,<br />

Tocopherolacetat<br />

174. Eisen-dextran-komplex<br />

100 mg/ml<br />

Eisen(III)-hydroxid-<br />

Dextrankomplex<br />

Dextran<br />

Sol. 100 mg,<br />

10 000 UI,<br />

1 000 UI,<br />

10 mg<br />

100 ml<br />

Sol. 100.0 mg/ml<br />

200.0 mg/ml<br />

100 + 500 ml<br />

175. Ektifo. Bromfenvinphos Sol. 200 mg<br />

1+2+5ml<br />

176. Engemycin 5 %, 10 % sol. Oxytetracycline-base Sol. 50 mg + 100 mg/ml<br />

50 + 100 ml<br />

177. ENROBIOFLOX 10 %<br />

SOLUTION<br />

Enrofloxacin Sol. 10.0 g/100 ml<br />

25+50+100+ 250+500+<br />

1000 ml<br />

178. ENROBIOFLOX 5 % Enrofloxacin Sol. 5 g/100 ml<br />

50 + 100 ml<br />

179. ENROFLON 10 % SOLUTION<br />

FOR ORAL USE<br />

Enrofloxacinum Sol. 10 g/100 g<br />

500 ml<br />

180. Enroxil 15 mg Enrofloxacin Tabl. 15 mg<br />

20 + 30 tabl.<br />

181. Enroxil 150 mg Enrofloxacin Tabl. 150 mg<br />

20 + 30 tabl.<br />

182. ENROXIL 2.5 % ORAL<br />

SOLUTION,<br />

ENROXIL 10 % ORAL<br />

SOLUTION<br />

183. ENROXIL 5 % INJECTION,<br />

ENROXIL 10 % INJECTION<br />

Enrofloxacine Sol. 2.5 g arba 10.0 g/100 ml<br />

100+1000 ml<br />

Enrofloxacine Sol. 5.0 g arba 10.0 g/100 ml<br />

50+100 ml<br />

184. ENROXIL 5 % POWDER Enrofloxacine powder 5.0 g/100 g<br />

100+1000g+ 25 kg<br />

185. EQUALAN PASTE Ivermectin Paste 18,7 mg<br />

6,42 g<br />

186. EQUEST 2 % oral gel for<br />

horses,<br />

Moxidectin solid Susp. 2.1 %w/w<br />

11.5 g<br />

Marketing<br />

authorisation holder<br />

Bimeda Chemical<br />

Exp.<br />

Ceva Sante Animale<br />

KRKA, d.d.<br />

KRKA, d.d.<br />

Atarost GmbH & Co.<br />

CP-Pharma Burgdorf<br />

CP-Pharma Burgdorf<br />

Atarost GmbH<br />

Bioveterinary Works<br />

BIOVET<br />

Intervet International<br />

Zakłady<br />

Farmaceutyczne<br />

‘BIOWET’ Sp. z o. O.<br />

Biowet Gorzow.<br />

OOO ‘VIK —<br />

zdorovqí Øivotnyx’<br />

(VIK — zdorovje<br />

zˇivotnych)<br />

KRKA<br />

KRKA<br />

KRKA, d.d.<br />

KRKA, d.d.<br />

KRKA, d.d.<br />

MERIAL<br />

Fort Dodge Animal<br />

Health


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 409<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

187. ERYTHROMYCINE 10 % Erythromycine thiocyanate powder 13.4 g/100 g<br />

1+5+10 kg<br />

188. Eritrocitarinis antigenas Erytrocyte antigen Susp. 10%<br />

1,5 ml<br />

189. ERITROMICINA 20 % Erythromycin (under form of<br />

thiocyanate salt)<br />

190. ERYTROWET® Erythromycin thiocyanate<br />

equivalent of Erythromycin<br />

base<br />

191. ESTRON inj. ad us. vet. Cloprostenolum natrium<br />

Chlorocresolum<br />

192. Euter Suspension Veyx inj. Tetracyclin hydrochlorid,<br />

Neomycin sulfate,<br />

Streptomycin sulfate<br />

193. EVETSEL® Vitamin E<br />

Sodium selenite<br />

194. Ewokal, sol. Calcium chloride,<br />

Magnesium chloride,<br />

Cobalt sulfate,<br />

Sodium chloride<br />

195. Ewosyt Glucos+tricalcium phosphate,<br />

Monosodiumgliutomate,<br />

Citric acid<br />

196. Excenel RTU Ceftiofur hydrochloride,<br />

Phospholipol 90<br />

197. Exuter P, Exuter M, uterus tabl. Neomycin sulfate,<br />

Oxychinolini sulfas,<br />

Oxytetracyclini chloratum<br />

198. FEBRIVAC 3-PLUS Inactivated mink enteritis virus<br />

Clostridium botulinum type C<br />

toxoid<br />

Inactivated Pseudomonas<br />

aeruginosa bacteria Hab's<br />

serotype 5, 6 and 7/8<br />

199. FEBRIVAC 3-PLUS D Inactivated mink enteritis virus<br />

Clostridium botulinum type C<br />

toxoid<br />

Inactivated Pseudomonas<br />

aeruginosa bacteria Hab's<br />

serotype 5, 6 and 7/8<br />

Modified live distemper virus<br />

strain D84/1<br />

200. FELOCELL CVR Feline panleukopenia virus<br />

(FPL)<br />

Feline rhinotracheitis virus<br />

(FVR)<br />

Feline calcivirus (FCV),<br />

strain F-9<br />

Strength<br />

powder 200 g/kg<br />

100+1000+ 5000 g<br />

powder 0.050 g/g<br />

100 g<br />

sol 0.25 mg<br />

1.0 mg/ml<br />

2+4+10+20 ml<br />

Susp. 30 mg,<br />

22,5 mg,<br />

6,5 mg/ml<br />

200 ml<br />

sol 750 mg<br />

10,95 mg/10 ml<br />

10 ml<br />

Sol. 30 g,<br />

5g,<br />

0,035 g,<br />

0,3 g/100 ml<br />

500 ml<br />

Powder 62,575 %,<br />

2,699 %,<br />

9,068 %<br />

3,5 kg<br />

Susp. 50 mg/ml,<br />

0.5 mg/m<br />

100 ml<br />

Tabl. 0,25-0,5 g,<br />

0,335-0,67 g,<br />

0,25-0,5 g<br />

1 + 2 tabl.<br />

Susp. at least 10 4 TCID 50<br />

at least 2,5×10 4 MLD 100<br />

at least 10 8 cells per serotype<br />

50+250+500 doses<br />

Susp. at least 10 4 TCID 50<br />

at least 2,5×10 4 MLD 100<br />

at least 10 8 cells per serotype<br />

at least 10 3,7 TCID 50<br />

250 doses<br />

Liof. ‡10 3 CCID 50<br />

‡10 5.7 CCID 50<br />

‡10 6.2 CCID 50<br />

1 dose<br />

Marketing<br />

authorisation holder<br />

Laboratoires Sogeval<br />

Ukrainian<br />

Experimental Clinical<br />

Institute for<br />

Veterinary and<br />

Medicine<br />

Chemifarma S.p.A.<br />

Tarchomin<br />

Pharmaceutical<br />

Works ‘Polfa’ S.A.<br />

Bioveta Plc.<br />

Veyx-Pharma GmbH<br />

PLIVA Kraków<br />

Zakłady<br />

Farmaceutyczne S.A.<br />

Suomen Rehu Ltd.<br />

Suomen Rehu Ltd.<br />

Pharmacia<br />

Biogal<br />

Pharmaceutical<br />

Works<br />

Impfstoffwerk<br />

Dessau-Tornau<br />

GmbH<br />

Impfstoffwerk<br />

Dessau-Tornau<br />

GmbH<br />

Pfizer Animal Health


EN<br />

410 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

201. FELOVAX® PCT-R, vakcina Inactivated Feline<br />

panleukopenia virus stock<br />

(R.P.*‡1.0)<br />

Inactivated Feline calicivirus<br />

(strain 255) stock (R.P.‡1.0)<br />

Inactivated Feline<br />

rhinotracheitis virus (strain<br />

605) stock (R.P.‡1.0)<br />

Inactivated Rabies virus (strain<br />

CVS-27) stock (R.P.‡2.6)<br />

Pharmaceutical<br />

form<br />

Susp. 0.1 ml<br />

0.1 ml<br />

0.5 ml<br />

0.072 ml<br />

1+5+10 dosis<br />

Strength<br />

202. Fenbenat 4% powder Fenbendazole Powder 40 mg/g<br />

200 + 500 + 1000 g<br />

203. Fenbenum Fenbendazolum Tabl. et<br />

Gran.<br />

204. Ferrovet Iron dextran 10 % (Fe 3+ )<br />

Dextran (m.m. 500)<br />

205. Ferrum 10 % Iron,<br />

Low molecular dextran<br />

250 mg/tabl.,<br />

500 mg/g granules<br />

SOL. 100 mg<br />

115 mg/ml<br />

50+100+250 ml<br />

Sol. 100 mg,<br />

150 mg<br />

100 ml<br />

Marketing<br />

authorisation holder<br />

Fort Dodge Animal<br />

Health<br />

Naturan Join Venture<br />

Lithuanian<br />

Veterinary Institute<br />

Zakłady<br />

Farmaceutyczne<br />

‘BIOWET’ Sp. z o.o.<br />

Bremer Pharma<br />

206. Fertagyl pro inj. Sol. 5 ml Intervet International<br />

207. Flubactin Flumequine Sol. 200 mg<br />

100 ml + 1 l<br />

208. Flubendazol 5 % Flubendazol Powder 50 mg<br />

600 g + 25 kg<br />

KRKA<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

209. FLUBENOL 5- 50% PREMIX Flubendazole Powder 50-500 mg JANSSEN<br />

PHARMACEUTICA<br />

N.V.<br />

210. FLUMECHINA 50 % Flumequine Sol. 500 g/l<br />

1+5 l<br />

211. Flumesol 5% pro inj. Flumequine Sol. 50 mg/ml<br />

1l<br />

212. Flumisol drinkable solution Flumequine Sol. 10 g<br />

50 + 500 + 1000 ml<br />

213. Flumival 20 % Flumequine Sol. 20 g<br />

100 ml<br />

214. Flumix 10% pulv. Flumequine Powder 100 mg/g<br />

1kg<br />

215. Flunixin Flunixin Sol. 50 mg/ml<br />

50 + 100 ml<br />

Chemifarma S.p.A.<br />

Dopharma B.V.<br />

Ceva Sante Animale<br />

Sogeval Laboratoires<br />

Dopharma B.V.<br />

Norbrook<br />

Laboratories Limited<br />

Station Works<br />

216. Fluwarol Fluvaliwate 250 mg Bioveterinary Works<br />

BIOVET<br />

217. FORCE 10 Liquide Vitamin complex Sol. 1 + 5 l Laboratoires<br />

SOGEVAL<br />

218. FOSFOSANAS Hexamethylentetraminum,<br />

Natrii phosphatum,<br />

Dinatrii phosphatum<br />

Sol. 20 g,<br />

1.1 g,<br />

11 g<br />

200 ml<br />

219. FRONTLINE® SPOT-ON CAT Fipronil Sol. 10.0 g/100 ml<br />

0.5 ml<br />

220. FRONTLINE® SPOT-ON DOG Fipronil Sol. 10.0 g/100 ml<br />

0.67+1.34+2.68 ml<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

Merial<br />

Merial


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 411<br />

No. Commercial name General name<br />

221. Fucidin Comp. Diolamini fusidas,<br />

Framycetini sulfas,<br />

Nystatinum,<br />

Prednisolonum<br />

Pharmaceutical<br />

form<br />

Oil. susp. 5 mg,<br />

2,5 mg,<br />

100 000 IE,<br />

2,5 mg<br />

10 ml<br />

222. Fungiderm 0,5% sol. Clotrimazolum Sol. 500 mg/100 ml<br />

100 ml<br />

223. Furosemide 5 % Furosemide Sol. 50 mg/ml<br />

50 ml<br />

224. GABON PA 92 Acrinathrin Strips 1,2-1,7 mg/strip<br />

50 strips<br />

225. Gallimycin 50 injectable<br />

solution (Erythrocin Vet 50)<br />

226. GALLIMUNE 201 IBD+REO Infectious bursal disease virus<br />

Avian viral arthritis reovirus<br />

<strong>227</strong>. GALLIMUNE 403<br />

ND+IB+IBD+REO<br />

228. GALLIMUNE 407<br />

ND+ID+EDS+ART<br />

Erithromycin Sol. 5 g<br />

100 ml<br />

Newcastle Disease, Infectious<br />

Bursal Disease, Viral Arthritis<br />

and Avian Infectious<br />

Bronchitis Vaccine<br />

Inactivated Newcastle disease<br />

virus<br />

Inactivated infectious<br />

bronchitis virus<br />

Inactivated avian<br />

rhinotracheitis virus<br />

Inactivated egg drop syndrome<br />

virus<br />

229. GALLIMUNE SE Vaccine against fowl<br />

salmonellosis<br />

230. Gelliprim orale Sulfadiazine,<br />

Trimethoprim<br />

231. GENABIL Menbutone (as diethanolamine<br />

salt)<br />

Chlorocresolum<br />

Sol. 10 5.7 CCID 50<br />

10 7 CCID 50;<br />

1000 doses<br />

Strength<br />

Susp. Newcastle disease virus >10 8<br />

EID 50; Infectious bronchitis<br />

virus >10 6,7 EID 50; Infectious<br />

bursal disease virus >10 5,7<br />

CCID 50; Avian viral arthritis<br />

virus >10 7 CCID 50/0.3 ml<br />

1000 doses<br />

Susp. £10 HI.Ufr<br />

£10 HI.U<br />

£60 IPU<br />

£162 HI.U<br />

10 00 doses<br />

Susp. Salmonella enteritidis<br />

>3,75×10 9 CFU/0.3 ml<br />

1000 doses<br />

Sol. 20 g,<br />

4 g/100 ml<br />

500 + 1000 ml<br />

Sol. 100 mg<br />

2 mg/ml<br />

100 ml<br />

232. Genta — kel 5 % Gentamicin Sol. 50000 I.U<br />

30 + 50 + 100 + 250 ml<br />

233. Gentamast Gentamycin sulfate Susp. 170 mg<br />

7.5 g<br />

234. GENTAMICIN 40 mg/ml,<br />

GENTAMICIN 80 mg/ml<br />

Gentamicin (in the form of<br />

sulphate)<br />

Sol. 40.0 mg or 80.0 mg/ml<br />

2+5+10+20+50 ml<br />

235. Gentamicin 5% pro inj. Gentamycini sulfas Susp. 85 mg/ml<br />

50 ml<br />

236. Gentamicin injection<br />

40 mg/ml<br />

Gentamicin sulfate Sol. 40 mg/ml<br />

2,5 + 10ml + 50 + 100 ml<br />

Marketing<br />

authorisation holder<br />

Leo Pharmaceutical<br />

Products Ltd.<br />

Polfa Grodzisk<br />

Alfasan International<br />

B. V.<br />

Bee Research<br />

Institute<br />

Ceva Sante Animale<br />

Merial Italia S.p.A.<br />

MERIAL Italia S.p.A.<br />

Merial Italia S.p.A.<br />

MERIAL Italia S.p.A,<br />

S.S. 234 per<br />

Cremona km. 28,2,<br />

27013 Chignolo Po,<br />

Pavia, Italy<br />

Farmaceutici Gellini<br />

S.P.A.<br />

Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

Kela Laboratoria<br />

N.V.<br />

Bremer Pharma<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d.d.<br />

Bremer Pharma<br />

GmbH<br />

Vet Prom Ltd.


EN<br />

412 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

237. GENTAMICIN U Gentamicinsulfat Tab. 312.0 mg/tabl.<br />

10 tab.<br />

238. GENTAMICIN water soluble<br />

powder<br />

239. GENTAPEN UDDER<br />

INJECTOR 10g<br />

240. GEOMYCIN® F intrauterine<br />

tablets<br />

241. GEOMYCIN® RETARD 20 %<br />

solution for injection<br />

Gentamicin (in the form of<br />

sulphate)<br />

Gentamicin sulphate<br />

Procaine benzylpenicillin<br />

242. GEOTILIN P. Tiamulin,<br />

Oxytetracycline<br />

243. Gynobiotic Neomycin sulfate,<br />

Oxytetracycline hydrochloride<br />

244. Gyva virusine˙ vakcina iš vištu˛<br />

Herpes viruso Rispens<br />

kamieno nuo Mareko ligos<br />

powder 10.0 g/100 g<br />

100+1000 g<br />

Strength<br />

Susp. 250 mg<br />

2 500 000 I.U/10 g<br />

10 g syr.<br />

Oxytetracycline hydrochloride Tabl. 1.0 g/tabl.<br />

2.0 10 tabl.<br />

Oxytetracycline (as dihydrate) Sol. 200.0 mg/ml<br />

100+500 ml<br />

Marek's Disease Vaccine,<br />

Living<br />

Powder 20 g,<br />

60 g/kg<br />

200g+1+5+25kg<br />

Tabl. 0.35 g,<br />

0.5g,<br />

18 tabl.<br />

Susp. Herpes virus 1,000 PFU/dose<br />

1+2+3+4ml<br />

245. Glaucipect Colistinsulfat Sol. 20 mg<br />

100 ml<br />

246. Glycero-Phosphat-Losung Dinatrium-1-glycerophosphat,<br />

Natrium-calcium edetat<br />

247. GLUCALVET Potassium chloride,<br />

Magnesium chloride,<br />

Glucose<br />

248. GONAVET 50®<br />

(DEPHERELIN®)<br />

249. Gumboriffa Infectious Bursal Disease<br />

Vaccine, Inactivated<br />

250. Gumboro vaccine nobilis Vaccine against Gumboro<br />

disease<br />

251. Gumboro Vaccine Nobilis,<br />

strain 228E<br />

Sol. 13,7 g/100 ml,<br />

0,025 g/100 ml<br />

100 ml<br />

Sol. 8 g,<br />

3g,<br />

5 g/100 ml<br />

D-Phe 6 -LHRH Sol. 0.05 mg/ml<br />

10+50 ml<br />

Avian Infectious Bronchitis<br />

Vaccine<br />

252. Gumbovax Plus (BUR-706) Infectious Bursal Disease<br />

Vaccine<br />

Susp. Gumboro disease virus,<br />

>10 5.7 CCID 50<br />

1500 + 1000 doses<br />

Marketing<br />

authorisation holder<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d.d.<br />

Dr. E. Gräub AG<br />

Pliva Pharmaceutical<br />

Industry Inc.<br />

Pliva Pharmaceutical<br />

Industry Inc.<br />

PLIVA D. D. B.V.<br />

Lek Pharmaceutical<br />

chemical company<br />

D.D.<br />

Lithuanian<br />

Veterinary Institute<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Atarost<br />

Zaklady<br />

Farmaceutyczne<br />

‘BIOWET GORZOW’<br />

Veyx-Pharma GmbH<br />

Merial<br />

Liof. vac 1 000 + 2 500 + 5 000 doses Intervet International<br />

Susp. 1 000 doses Intervet International<br />

Lyoph. vac. Infectious bursal disease virus<br />

> 4,0 TCID 50/dose<br />

1000 + 2000 + 5000 doses<br />

253. Gzavon-2 Foschlor (trichlorfon) Sol. 5,0<br />

500 ml<br />

254. H — 120 vaccine Avian Infectious Bronchitis<br />

Vaccine, Living<br />

255. Hefrotrim susp. Sulfadimidine,<br />

Trimethoprim<br />

Lyoph. vac. IBD virus 95 %<br />

1000 + 1000 + 2500 + 5000<br />

doses<br />

Susp. 215,8 mg,<br />

40 mg/ml<br />

50 + 100 ml<br />

MERIAL ITALIA<br />

Biowet-Gorzow<br />

Abic Ltd.<br />

Bremer Pharma<br />

GmbH


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 413<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength<br />

Marketing<br />

authorisation holder<br />

256. Helosan Hygienic ointment Ointm. 100 + 300 + 1000 g Pharmacia<br />

257. Hematopan B 12 pro inj. Sol. 10 ml + 50 ml Rhone Merieux<br />

258. Hexadog vaccine Canine Distemper, Adenovirus<br />

and Parvovirus Vaccine,<br />

Inactivated<br />

Rabies and Leptospirosis<br />

Vaccine<br />

259. HEXIDERM sol. and spray Hexetidine,<br />

Prednisolone,<br />

Benzocaine<br />

Liof. vac.,<br />

liquid vac.<br />

100 mg,<br />

1ml<br />

Sol. 0.150 g,<br />

0.125 g,<br />

2 g/100 ml<br />

35 ml<br />

260. Hipralona Enro S, sol. Enrofloxacin Sol. 100 mg/ml<br />

1 000 ml<br />

261. Hipravit — T Vitamin A,<br />

Vitamin D3,<br />

Vitamin E,<br />

Vitamin K,<br />

Vitamin B1,<br />

Vitamin B2,<br />

Vitamin B6,<br />

Vitamin B12,<br />

Vitamin C,<br />

Nicotinic acid,<br />

Pantotenic acid<br />

262. HIPRAVIT-SE Vitamin E (α-tocopherol<br />

acetate)<br />

Sodium selenite<br />

263. IB 201 Sodium sulphadimethoxine,<br />

Phenylbutazone,<br />

Sodium salicylate<br />

264. IB Vaccine Nobilis H-52 Avian Infectious Bronchitis<br />

Vaccine<br />

265. IB+ND Vaccine Nobilis<br />

Ma5+Clone 30<br />

266. Yersinia-Diagnostik:<br />

Monospezifische Testseren<br />

‘Anti-Yersiniaenterocolitica’,<br />

Yersinia enterocolitica O-<br />

Testantigener fur die Mikro-<br />

Widal-Reaktion gefarbt.;<br />

Kontrollseren ‘Anti-Yersinia<br />

enterocolitika’(03, 05, 09)<br />

Avian Infectious Bronchitis<br />

and Newcastle Disease Vaccine<br />

Monospecific sera for diagnosis<br />

of Yersinia<br />

267. ILINON® PLUS Nalidixic acid (in the form of<br />

sodium salt)<br />

Neomycin (in the form of<br />

sulphate)<br />

Sol. 10000 IU,<br />

2000 IU,<br />

5 mg,<br />

5 mg,<br />

8 mg,<br />

4 mg,<br />

5 mg,<br />

0.03 mg,<br />

5000 mg,<br />

40 mg,<br />

25 mg/ml<br />

Sol. 50,0 mg<br />

1,5 mg/ml<br />

100 ml<br />

Sol. 250 mg,<br />

37.25 mg,<br />

10 mg/ml<br />

100 + 250 ml<br />

Susp. Strain H-52 10 3 EID 50/dose<br />

1,000 + 2,500 + 5,000 doses<br />

Susp. IB strain Ma 10 3 EID 50/dose,<br />

ND strain Clone 30 10 6<br />

EID 50/dose<br />

1,000 + 2,500 doses<br />

Rhone Merieux<br />

Fort Dodge Animal<br />

Health<br />

Laboratorios Hipra<br />

Laboratorios Hipra<br />

Laboratorios Hipra,<br />

S.A.<br />

Fort Dodge Animal<br />

Health<br />

Intervet International<br />

Intervet International<br />

Susp. Institut fur<br />

Immunpraparate und<br />

Nahrmedien GmbH<br />

Berlin ‘SIFIN’<br />

powder 32.0 g<br />

6.0 g/100 g<br />

100+ 1000 g<br />

268. Imaverol sol. Enilconazolum Sol. 100 mg/ml<br />

100 + 1,000 ml<br />

269. Inavak G1-inj. a.u.v. Aujesky's Disease Vaccine,<br />

Inactivated<br />

270. Indigestion Powder Propionic acid sodium,<br />

Sodium hydrogen carbonate,<br />

Paracetamol<br />

Susp. Viral suspension<br />

76,6 ml/100 ml<br />

100 + 200 + 500 ml<br />

Powder 375 g,<br />

375 g,<br />

125 g<br />

100 + 1000 g<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d.d.<br />

Janssen Animal<br />

Health BVBA<br />

Mevak a.s. and<br />

Lithuanian<br />

Veterinary Institute<br />

Bremer Pharma


EN<br />

414 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

271. INGELVAC® AUJESZKY MLV Aujeszky's disease live virus<br />

(Bartha strain K-61)<br />

272. INGELVAC® PRRS MLV Porcine Reproductive and<br />

Respiratory Syndrome Virus,<br />

ATCC VR-2332 strain<br />

Pharmaceutical<br />

form<br />

Strength<br />

liof. Vacc. ‡10 6.0 TCID 50<br />

10+25+50 doses<br />

Live liof. Vacc. ‡10 4.9 TCID 50<br />

10+25+50 doses<br />

273. Insectin-proszek Permetrin Powder 1 g<br />

50 ir 100 g<br />

274. INSOL ® TRICHOPHYTON, Inactivated microconidia of:<br />

Trichophyton verrucosum<br />

(strain No. 410)<br />

Trichophyton mentagrophytes<br />

(strain No. 1032)<br />

Trichophyton sarkisovii (strain<br />

No. 551)<br />

Susp. at least 1.7×10 7<br />

at least 1.7×10 7<br />

at least 1.7×10 7 /1 ml<br />

50+100+250 ml<br />

275. Intertocine-S, pro inj. Oxytocinum Sol. 10 TV/ml<br />

10 + 25 + 50 ml<br />

276. Intramicine Dihydrostreptomycin sulfate,<br />

Procaine benzylpenicilin,<br />

Procaine hydrochloride<br />

Sol. 20.000 MIU,<br />

20 g,<br />

2g<br />

100 + 250 ml<br />

277. Ivermectin 1% pro inj. Ivermectin Sol. 10 mg/ml<br />

50 + 100 + 250 ml<br />

278. Jodopharm (Jodozol) Iodum,<br />

Kalii iodidum,<br />

Palawax A 31,<br />

Dimethyl sulphoxide<br />

279. Jungtier Suspension inj. Veyx Tetracyclin hydrochlorid,<br />

Neomycin sulfate,<br />

Streptomycin sulfate<br />

280. K.C.N.D. Kanamycin Sulfate,<br />

Colistinsulfate,<br />

Neomycin Sulfate,<br />

Dexamethasone Sodium<br />

Phosphate<br />

281. KALCIO<br />

BOROGLIUKONATAS<br />

Calcii gluconas,<br />

Natrium tetraboratum,<br />

Acidum boricum<br />

282. KAMAGSOLAS Calcium chloride<br />

Magnesium chloride<br />

283. Kamagsolas — G Calcium chloride,<br />

Magnesium chloride,<br />

Glucose<br />

Aerosol 0,18 g/40 g,<br />

0,36 g/40 g,<br />

1,072 g/40 g,<br />

2,4 g/40 g<br />

40 g<br />

Susp. 30 mg,<br />

22,5 mg,<br />

6,5 mg/ml<br />

100 ml<br />

Sol. 50 mg,<br />

100000 IU,<br />

50 mg,<br />

0.5 mg<br />

100 ml<br />

Sol. 20 g,<br />

1.3 g,<br />

1.85 g<br />

200 ml<br />

Sol. 10.0 g<br />

3.0 g/100 g<br />

200+250+450+500<br />

Sol. 10 g,<br />

3g,<br />

40 g/100 ml<br />

284. Kanamycin 25 % Kanamycin Sulfate Sol. 250 mg<br />

100 ml<br />

285. KAOMYCIN® Neomycin sulphate Kaolin Sol. 3,5 mg<br />

986 mg<br />

ml<br />

475 ml+4l<br />

286. Kefamast Cephalexin monohydrate,<br />

Dihydrostreptomycin sulfate<br />

Susp. 500 mg,<br />

500 mg<br />

9g<br />

Marketing<br />

authorisation holder<br />

Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

Biowet Pulaway<br />

Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

Intervet International<br />

B.V.<br />

Ceva Sante Animale<br />

Biowet-Gorzow<br />

Vet Prom Ltd.<br />

Veyx-Pharma GmbH<br />

Alfasan International<br />

B. V.<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

Biofabrikas’<br />

Alfasan International<br />

B. V.<br />

Pharmacia<br />

Bimeda Chemicals<br />

export


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 415<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

287. Ketamine 10 % Ketamine hydrochloride Sol. 100 mg/ml<br />

10 ml<br />

288. Ketamine 1000 Ketamine (as hydrochloride) Sol. 10.0 g/100 ml<br />

10 ml<br />

289. KETOSAID Propylen glycol,<br />

Carmoisine<br />

Strength<br />

Sol. 1 ml,<br />

0.4 mg/ml<br />

1+2+5+10l<br />

290. Klatoclox pro inj. Cloxacillin Susp. 625 mg/10 ml<br />

10 ml<br />

291. KONSULFATRIM Sulfadiazine<br />

Trimethoprim<br />

powder 10.0 g<br />

2 g/100 g<br />

100+200+400+800 g<br />

292. Kubatol spray Acrylate copolymer Aerosol 4.3 g<br />

190 g<br />

293. Lancodry Cloxacilin,<br />

Ampicilin<br />

294. Laptovet p.i.N. Calcium glycerophosphat,<br />

Iron (III)-glycerophosphat<br />

Magnesium-2.3dihydroxypropylphosphat,<br />

Dinatrium-1-glycerinphosphat,<br />

Kobalt gluconat,<br />

Mangan chlorid<br />

295. LATOCILLIN Cloxacillin sodium<br />

monohydrat<br />

296. LATODURIN Cloxacillin benzathine sterile,<br />

Neomycin sulphate<br />

297. LAURITIN — S Acidum ascorbicum,<br />

Camphor<br />

298. LAUTECIN®<br />

.<br />

299. LEKASEPTAL® udder<br />

ointment<br />

Erythromycin propionate<br />

lauryl sulfate<br />

Tetracycline hydrochloride<br />

Eucalyptus oil<br />

Nutmeg oil<br />

Cedar oil<br />

Camphor<br />

Menthol<br />

Laurel leaf oil<br />

Chlorophyll<br />

300. LEKOMYCIN®-A solution Linkomycin<br />

Gentamicin<br />

301. Leo Yellow Milking Cow Penethamate hydroiodide,<br />

Dihydrostreptomicin,<br />

Framycetin sulfate,<br />

Prednisolone<br />

302. Leucorifelin inj. Feline Panleukaemia,<br />

Calicivirus and Herpes Vaccine<br />

303. Leukocell 2 Feline Leukaemia Vaccine,<br />

Inactivated<br />

Susp. 500 mg,<br />

250 mg<br />

4.5 g<br />

Sol. 2 g/100 ml,<br />

5 g/100 ml,<br />

4 g/100 ml,<br />

1 g/100 ml,<br />

0,02 g/100 ml,<br />

0,14 g/100 ml<br />

100 + 250 + 500 + 1000 ml<br />

Susp. 546 mg/10 ml<br />

10 ml<br />

Susp. 709 mg,<br />

704 mg/10 ml<br />

10 ml<br />

Sol. 10 mg,<br />

1 mg/ml<br />

100 ml<br />

powder 0.017 g<br />

0.033 g<br />

100 g<br />

Oint. 3.22 g<br />

0.16 g<br />

0.16 g<br />

0.16 g<br />

0.08 g<br />

1.21 g<br />

0.023 g/100 g<br />

350 g<br />

Sol. 257.143 g<br />

7.143 g/1 l<br />

140 ml<br />

Ointm. 150 mg,<br />

150 mg,<br />

50 mg,<br />

5mg<br />

20 injectors<br />

Marketing<br />

authorisation holder<br />

Alfasan International<br />

B. V.<br />

Virbac S.A.<br />

NORBROOK<br />

Laboratories Limited<br />

Bremer Pharma<br />

GmbH<br />

Zakłady<br />

Farmaceutyczne<br />

‘BIOWET’ Sp. z o. o.<br />

Aveflor a.s.<br />

Elanco Animal<br />

Health, Eli Lilly<br />

GmbH<br />

Atarost<br />

Zakłady<br />

Farmaceutyczne<br />

‘Biowet’ Sp. z o.o.<br />

Zakłady<br />

Farmaceutyczne<br />

‘Biowet’ Sp. z o.o.<br />

ImmCont GmbH<br />

Tarchomin<br />

Pharmaceutical<br />

Works ‘Polfa’ S.A.<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d. d.<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d. d.<br />

Leo Pharmaceutical<br />

Products Ltd.<br />

Vac. liof. 1 ml Rhone Merieux<br />

Susp. Feline Leukaemia virus<br />

>1334 ng/ml<br />

1 doze<br />

Pfizer Animal Health


EN<br />

416 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength<br />

304. LEVACIDE INJECTION Levamisole hydrochloride Sol. 7.5 %<br />

100 + 250 + 500 ml<br />

Marketing<br />

authorisation holder<br />

NORBROOK<br />

Laboratories Limited<br />

305. LEVAMISOL 100 Levamizole hydrochloride Sol. 100 mg/1 ml Invesa International,<br />

S.A.<br />

306. LEVAMISOL 4 %, LEVAMISOL<br />

8%<br />

Levamisol hydrochloride Powder 4 g or 8 g/100 g<br />

100 + 200 + 400 + 800 g<br />

307. Levamisol 7,5% Levamisole hydrochloride Sol. 7,5 g<br />

100 + 500 ml<br />

308. LEWAMIZOL 23,6 g FOR<br />

PIGEONS<br />

309. LEWAMIZOL 5 %,<br />

LEWAMIZOL 10 %<br />

Levamisole hydrochloride Tabl. 23.6 mg<br />

20 tab.<br />

Levamisole hydrochloride powder 50 or 100 mg<br />

200+300+1000 g<br />

310. LEWAMIZOL 75 g Levamisole hydrochloride Tabl. 75 mg<br />

20 tab.<br />

311. Lydium-KLP 0,1, 0,2, 0,5, 1%,<br />

pro inj.<br />

312. Life — Aid Xtra Sodium citrate,<br />

Sodium acetate,<br />

Sodium propionate,<br />

Sodium chloride<br />

Potassium chloride<br />

Potassium dihydrogen<br />

orthophosphate<br />

Lysozymum dimerisatum Sol. 1 mg or 2 mg, or 5 mg, or<br />

10 mg<br />

10 ml<br />

Powder 4.681 %w/w,<br />

3.917% w/w/,<br />

2.293 % w/w,<br />

5.589% w/w,<br />

3.559% w/w,<br />

1.624 % w/w<br />

83.74 g<br />

313. Lincobel pro inj. Lincomycini hydrochloridum Sol. 113,4 mg/ml<br />

50 + 100 ml<br />

314. LINCOCIN FORTE S Lincomycin hydrochloride<br />

Neomycin sulphate<br />

315. Lincomycin — Spectinomycin Lincomycin hydrochloride<br />

Spectinomycinhydrochloride<br />

316. LINCOMIX® 44 PREMIX,<br />

LINCOMIX® 110 PREMIX<br />

317. Linco-Spectin 100 pulv. Lincomycini hydrochloridum,<br />

Spectinomycini sulfas<br />

318. Linco-Spectin Premix Lincomycini hydrochloridum,<br />

Spectinomycini sulfas<br />

319. LINCO-SPECTIN® STERILE<br />

SOLUTION<br />

Sol. 330 mg<br />

100 mg/10 ml<br />

10 ml<br />

Sol. 50 mg<br />

100 mg<br />

100 ml<br />

Lincomycin hydrochloride Powder 44 or 110 g/kg<br />

5kg<br />

Lincomycin hydrochloride<br />

Spectinomycin sulphate<br />

320. LINKOFARM 110-PREMIX Lincomicin (under form of<br />

hydrochloride) salt<br />

321. LINKOMICIN Lincomycin (in the form of<br />

hydrochloride)<br />

322. LINKOMICIN 110 N Lincomycin (in the form of<br />

hydrochloride)<br />

Powder 33,3 g,<br />

66,7 g<br />

50 + 150 g<br />

Powder 22 g/kg,<br />

22 g/kg<br />

1kg<br />

Sol. 50 mg<br />

100 mg/ml<br />

50+100 ml<br />

powder 110 g/kg<br />

10+25 kg<br />

sol 100.0 mg/ml<br />

50 ml<br />

powder 11.0 g.100 g<br />

1+10 kg<br />

Zakłady<br />

Farmaceutyczne<br />

‘Biowet’ Sp. z o.o.<br />

Vet Prom Ltd.<br />

Grodziskie Zakłady<br />

Farmaceutyczne<br />

‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne<br />

‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne<br />

‘Polfa’<br />

Nika Health Products<br />

Norbrook<br />

Laboratories Limited<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Pharmacia<br />

Alfasan International<br />

B. V.<br />

Pharmacia<br />

Pharmacia<br />

Pharmacia<br />

Pharmacia<br />

Chemifarma S.p.A.<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d.d.<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d.d.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 417<br />

No. Commercial name General name<br />

323. LINKOMICIN F Lincomycin (in the form of<br />

hydrochloride)<br />

Neomycin (in the form of<br />

sulphate<br />

Dexamethasone-21-phosphate<br />

Pharmaceutical<br />

form<br />

Susp. 200.0 mg<br />

200.0 mg<br />

1.0 mg/10 mg<br />

2.0 10 ml syr.<br />

Strength<br />

324. LYSVULPEN por. ad us. vet. Rabies Vaccine for Foxes Bait Virus rabiei attentum 1.8 ×<br />

10 7 PFU/1.8 ml<br />

20 + 40 + 60 baits<br />

325. LITTERGUARD® LT-C E. coli, NADC 1471, F41<br />

E. coli, NADC 1413, 987P<br />

E. coli, pS002 1471, K88<br />

E. coli, NL-1005, NADC 1471<br />

K99<br />

E. coli, NL-1001, LT B<br />

C. perfringens Type C beta<br />

toxoid<br />

326. LIVACOX T SOL. Eimeria tenella (oocysts)<br />

Eimeria acervulina (oocysts)<br />

Eimeria maxima (oocysts)<br />

327. Live Gumboro vaccine Infectious Bursal Disease<br />

Vaccine, Living<br />

328. LONGOSONA Sodium propionate<br />

Calcium stearate<br />

D,L-methionine<br />

L-lysine<br />

Vitamin D 3<br />

329. LOPATOL 100, LOPATOL<br />

500<br />

Susp. ‡1.36 RP<br />

‡1.44 RP<br />

‡1.41 RP<br />

‡1.48 RP<br />

‡1.55 RP<br />

‡10 IAU<br />

1+5+10+25+50 doses<br />

Sol. 3-5×10 4<br />

3-5×10 4<br />

3-5×10 4<br />

50+200 ml<br />

Lyoph. vac. IBD virus 95 %<br />

1000 + 2500 + 5000 doses<br />

Powder 400 mg<br />

100 mg<br />

50 mg<br />

10 mg<br />

100 IU/g<br />

2+3+10 kg<br />

Marketing<br />

authorisation holder<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d.d.<br />

Bioveta Plc.<br />

Pfizer Animal Health<br />

Biofarm, Research<br />

Institute of<br />

Biopharmacy and<br />

Veterinary drugs<br />

Abic Ltd.<br />

Invesa International<br />

Nitroscanate micronized Tabl. 100 or 500 mg Novartis Santé<br />

Animale SA<br />

330. MADYL INJECTION Carprofen Sol. 50.0 mg/ml<br />

20 ml<br />

Pfizer Oy Animal<br />

Health<br />

331. MAGNIJECT Magnesium sulfate Sol. 250 mg/ml NORBROOK<br />

Laboratories Limited<br />

332. Mamexine Kanamycin sulfate,<br />

Cephalexine<br />

333. Mamiseptol. Camphor,<br />

Methylsalicylate<br />

Susp. 100 000 IU,<br />

200 mg<br />

10 g<br />

Ung. 50 mg,<br />

20 mg<br />

450 + 1 000 g<br />

C.Richter Gesmbh<br />

CP-Pharma Burgdorf<br />

334. Marek vaccine nobilis Liof. vac. 1 000 + 2 000 doses Intervet International<br />

335. MAREK'S DISEASE VACCINE,<br />

Serotype 3, Live Virus<br />

Marek's Disease virus, FC-126<br />

strain<br />

336. MASTESTAS Sodium laurylsulphate<br />

Bromcresolum purpurea<br />

337. Masti — kel NP Procaine benzylpenicillin,<br />

Neomycin sulfate<br />

338. MASTI VEYXYM® Chymotrypsin<br />

Trypsin<br />

Papain<br />

Liof. ‡1.466 pfu<br />

1000 doses<br />

Sol. 3 %<br />

0,01 %<br />

105+210+420 ml<br />

Susp. 30 mg,<br />

50 000 IU<br />

10 g<br />

Susp. 8.00 mg<br />

8.00 mg<br />

4.00 mg/10 g<br />

10 g syr.<br />

Merial<br />

Lithuanian<br />

Veterinary Institute<br />

Kela Laboratoria<br />

Veyx-Pharma GmbH


EN<br />

418 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

339. MASTI VEYXYM® FORTE Benzylpenicillin Sodium<br />

Framycetin sulphate<br />

Chymotrypsin<br />

Trypsin<br />

Papain<br />

Pharmaceutical<br />

form<br />

Susp. 606.00 mg<br />

200.00 mg<br />

4.00 mg<br />

4.00 mg<br />

2.00 mg/20 g<br />

20 g syr.<br />

340. MASTICEF Cefacetril sodium Susp. 250 mg/8 g<br />

8g<br />

341. Mastijet forte, susp. Tetracyclini hydrochloridum,<br />

Neomycini sulphas,<br />

Bacitracinum,<br />

Prednisolonum<br />

342. MASTILEX Cephalexin monohydrate<br />

Gentamicin sulfate<br />

343. MASTIPEN L Benzylpenicilline sodium,<br />

Dihydrostreptomycine sulphat,<br />

Nafcilline sodium,<br />

Prdnisolone<br />

344. MASTIPEN Z Procainbenzilpenicilline,<br />

Dihydrostretomycine sulfate,<br />

Nafcillin sodium,<br />

Clotrimasole<br />

345. Mastipra, sol. inj. Erythromycin,<br />

Sulphadimethoxine<br />

Trimethoprim<br />

346. Mastisan PN/DC, Mastisan<br />

PN/MC<br />

347. Mastitis — Schnelltest<br />

‘Bernburg’<br />

Benzylpenicillinumn<br />

procainicum,<br />

Neomycinum sulfuricum<br />

Susp. 206 mg,<br />

368 mg,<br />

28 mg,<br />

10,1 mg/8g<br />

10 ml<br />

Susp. 350 mg<br />

35 mg<br />

syringes<br />

Susp. 180 mg,<br />

125 mg,<br />

110 mg,<br />

7 mg/3 g<br />

3g<br />

Susp. 300 mg,<br />

125 g,<br />

110 mg,<br />

60 mg/3 g<br />

3g<br />

Sol. 50 mg/ml,<br />

125 mg/ml,<br />

25 mg/ml<br />

100 ml<br />

Strength<br />

Susp. 300000-600000 IU,<br />

150000-300000 IU<br />

5-10 g<br />

Marketing<br />

authorisation holder<br />

Veyx-Pharma GmbH<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweteryjnego S.A.<br />

Intervet International<br />

Invesa International<br />

S.A.<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweteryjnego S.A.<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweteryjnego S.A.<br />

Laboratorios Hipra<br />

Przedsie˛biorstwo<br />

Wielobranzˇowe, Vet<br />

Agro<br />

Alkylarylsulfonat sol. 2 g Serum — Werk<br />

Bernburg AG<br />

348. MEPATAR® Oxytetracycline hydrochloride powder 0.05 g/g<br />

100 g<br />

349. METACAM® 0,5 % injection<br />

for cattle<br />

350. METACAM® 0,5 % injection<br />

for dogs<br />

Meloxicam<br />

Meglumine<br />

Glycufurol<br />

Meloxicam<br />

Meglumine<br />

Glycufurol<br />

351. Metawetrim pulv. Sulphametazine,<br />

Trimethoprim<br />

Sol. 5 mg<br />

3,125 mg<br />

100 mg/ml<br />

100 ml<br />

Sol. 5 mg<br />

3,125 mg<br />

100 mg/ml<br />

10 ml<br />

Powder 0,1 g,<br />

0,02 g<br />

352. Methionin-Losung 20 % N-Acetyl-DL-methionin Sol. 26 g<br />

100 ml<br />

353. Metricure, susp. Cefapirin Susp. 500 mg/19 g<br />

19 ml<br />

354. Metrigent 200 Gentamicin sulfate Tabl. 200 000 IU<br />

10 + 20 + 50 + 100 tabl.<br />

355. Metrisan AN Neomycinum sulfuricum Susp. 300000 IU<br />

5-10 g<br />

Tarchomin<br />

Pharmaceutical<br />

Works ‘Polfa’ S.A.<br />

Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

Polfa Grodzisk<br />

Atarost GmbH & Co.<br />

Intervet International<br />

Kela Laboratoria<br />

Przedsie˛biorstwo<br />

Wielobranzˇowe Vet<br />

Agro


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 419<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength<br />

356. MG VAX Avian mycoplasmosis vaccine Susp. Mycoplasma gallisepticum<br />

suspension 10 9 CFU/0,5 ml<br />

250 +500 ml<br />

357. MICANFIN inj. sic. ad us. vet. Vaccine against Microsporum<br />

canis<br />

358. Mycoplasma meleagridis<br />

antigen Nobilis<br />

Susp. Microsporum canis > 500 000<br />

conidia or hyphae fragments/ml<br />

1ml<br />

Mycoplasma meleagridis antigen Susp. 1,5%<br />

10,5 ml<br />

359. Mycoplasma synoviae antigen Mycoplasma synoviae antigen Susp. 2 %<br />

10 ml<br />

360. Micotil Tilmicosin Sol. 300 mg<br />

50 + 100 + 250 ml<br />

361. MYELOVAX Infectious Avian<br />

Encephalomyelitis Vaccine<br />

362. Minerasol Sodium jodatum,<br />

Potassium jodatum,<br />

Zincum chloratum,<br />

Manganesium chloratum,<br />

Potassium chloratum,<br />

Magnesium chloratum,<br />

Cuprum bichloratum,<br />

Ferrum chloratum<br />

363. MYOLAXIN 15 % Guaiphenensin,<br />

Anhydrous glucose<br />

Lyoph. vac. CALNEK 1143 virus at least<br />

10 3 EID 50/dose<br />

1000 doses<br />

Sol. 50 mg,<br />

50 mg,<br />

4.282 mg,<br />

19.64 mg,<br />

4.282 mg,<br />

19,64 mg,<br />

0.22 mg,<br />

12.69 mg<br />

100 ml<br />

Sol. 15 g,<br />

4.546 g/100 ml<br />

500 ml<br />

364. MONOCILLIN Benzylpenicillin Procaine Susp. 4 mln. IU/10 ml<br />

10 ml<br />

365. Multiject IMM, susp. Procaine penicillin,<br />

Streptomycin sulfate,<br />

Neomycin sulfate,<br />

Prednisolone<br />

366. Multimast Neomycin sulfate,<br />

Procaine penicillin,<br />

Oxytetracycline hydrochloride,<br />

Prednisolone<br />

367. MULTIVIT INJ. Vitamin A<br />

Cholecalciferol<br />

Tocopherol acetate<br />

Thiamine hydrochloride<br />

Riboflavine sodium phosphate<br />

Pyridoxine hydrochloride<br />

Cyanocobalamin<br />

Ascorbic acid<br />

Nicotinamide<br />

D-Panthenol<br />

368. Multivitamin injection Thiamine hydrochloride,<br />

Riboflavine,<br />

Pyridoxide hydrochloride,<br />

Nicotinamide,<br />

Cyanocobalamin,<br />

Vitamin A,<br />

Vit. D3,<br />

Vit. E<br />

Susp. 20 mg/g,<br />

20 mg/g,<br />

20 mg/g,<br />

2 mg/g<br />

5g<br />

Susp. 250 mg,<br />

100 mg,<br />

50 mg,<br />

10 mg<br />

4.5 g<br />

Sol. 50.000 IU/ml<br />

25.000 IU/ml<br />

4,0 mg/ml<br />

2,5 mg/ml<br />

2,0 mg/ml<br />

1,25 mg/ml<br />

30 µg/ml<br />

2,0 mg/ml<br />

12,5 mg/ml<br />

3,0 mg/ml<br />

100 ml<br />

Sol. 10 mg,<br />

5 mg,<br />

3 mg,<br />

35 mg,<br />

50 mg,<br />

15000 IU,<br />

1000 IU,<br />

20 IU<br />

100 ml<br />

Marketing<br />

authorisation holder<br />

MERIAL Italia S.p.A.<br />

Bioveta Plc.<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

Elanco Animal<br />

Health, Eli Lilly<br />

GmbhB<br />

MERIAL<br />

C.Richter Gesmbh<br />

Co KG<br />

CHASSOT AG.<br />

Zakłady<br />

Farmaceutyczne<br />

‘Biowet’ Sp. z o.o.<br />

Norbrook<br />

Laboratories Ltd.<br />

Bimeda Chemicals<br />

export<br />

Dutch Farm<br />

Veterinary<br />

Pharmaceuticals B.V.<br />

Bimeda Chemicals<br />

export


EN<br />

420 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength<br />

Marketing<br />

authorisation holder<br />

369. Multivitamin, sol. inj. Vitamin complex Sol. 100 ml Norbrook<br />

Laboratories Ltd.<br />

370. N.D. vaccine Nobilis Hitchner<br />

B1<br />

Newcastle Disease Vaccine,<br />

Living<br />

371. Nafpenzal DC Benzylpenicillin procaine,<br />

Nafcillin sodium,<br />

Dihydrostreptomycin sulfate<br />

372. Nafpenzal MC Benzylpenicillin sodium,<br />

Nafcillin sodium,<br />

Dihydrostreptomycin sulfate<br />

373. ND Vaccine Nobilis, Clone 30 Avian Newcastle Disease<br />

Vaccine<br />

374. NEMOVAC Attenuated Swollen Head<br />

Syndrome virus,<br />

375. Neo — Te — Sol pulvis Oxytetracycline hydrochloride,<br />

Neomycin sulfate<br />

376. Neo-Cholentyl 0,1% fur<br />

Großtiere<br />

377. Neo-Diarrhoecombin, pulv. Neomycin sulfate,<br />

Succinyl sulfathiazol,<br />

Atropin sulfate<br />

Sulfamidin<br />

378. Neomastipra JR5 Procaine Penicillin,<br />

Polymyxin B sulfate,<br />

Dihydrostreptomycin sulfate,<br />

Neomycin sulfate,<br />

Sodium sulphamide,<br />

Sulphtiazol<br />

379. NEOMASTIPRA SEC Cloxacilin benzathine,<br />

Sulphadimidine,<br />

Trimethoprin<br />

380. NEOMASTIPRA-DRY Benzilpenicilin procaine,<br />

Novobiocine<br />

381. NEOMASTIPRA-FUNG Amoxycilin trihydrate,<br />

Nystatin,<br />

Hydrocortisone<br />

382. Neo-Pen susp. pro inj. Procaine-Penicilin,<br />

Neomycin sulfate<br />

6.0 log EID 50 of Newcastle<br />

disease virus<br />

500 + 1,000 + 2,500 + 3,000<br />

+ 5,000 + 10,000 doses<br />

297,92 mg,<br />

100 mg,<br />

100 mg/3 ml<br />

3g<br />

Susp. 180,07 mg,<br />

100 mg,<br />

100 mg/3 ml<br />

3g<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

Intervet International<br />

Susp. 1,000 + 2,500 doses Intervet International<br />

Liof. ‡10 2.3 CCID 50<br />

1000+5000 doses.<br />

Powder 18.0 g,<br />

12.0 g<br />

50 + 250 + 1000 g<br />

Carbachol Sol. 0,1 g/100 ml<br />

10 + 100 ml<br />

Powder 6 g/kg,<br />

60 g/kg,<br />

4 mg/kg,<br />

30 g/kg<br />

100g+1+25kg<br />

Susp. 10 000 IU/ml,<br />

5 000 IU/ml,<br />

6,24 mg/ml,<br />

3,6 mg/ml,<br />

25 mg/ml,<br />

25/ml<br />

10 ml<br />

Susp. 500 mg,<br />

750 mg,<br />

125 mg/10 ml<br />

10 ml<br />

Susp. 200000 IU,<br />

400 mg/10 ml<br />

10 ml<br />

Susp. 1,000 mg,<br />

5 M.I.U.,<br />

20 mg/10 ml<br />

10 ml<br />

Susp. 200 mg/ml,<br />

150 mg/ml<br />

100 ml<br />

383. NEOPITROID EC 20 Permethrin Emmulse 20 g/100 ml<br />

100 ml<br />

384. Neoprocpen susp. inj. Neomycin sulfat,<br />

Benzylpenicillin Procain<br />

385. NEOSOL Neomycin sulphate<br />

Sodium metabisulphite<br />

Sodium citrate dihydrate<br />

Susp. 145 mg/ml,<br />

200 000 UI/ml<br />

100 ml<br />

Sol. 145 g<br />

3g<br />

15 g/1000 ml<br />

50+90+900 ml<br />

Merial<br />

Biogal Ph. W.<br />

Atarost<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Laboratorios Hipra<br />

Laboratorios Hipra<br />

S.A.<br />

Laboratorios Hipra<br />

S.A.<br />

Laboratorios Hipra<br />

S.A.<br />

Intervet International<br />

BV<br />

PLIVA d. d. B.V.<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Zakłady<br />

Farmaceutyczne<br />

‘BIOWET’ Sp. z o.o.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 421<br />

No. Commercial name General name<br />

386. Neostomosan, sol. Transmix,<br />

Tetramethrin<br />

387. Neotylum Tylosin base,<br />

Neomycine sulfate,<br />

Dimethyl sulphoxide<br />

388. NEWCASTLE-K Newcastle Disease Vaccine,<br />

Inactivated<br />

389. Nobi — Equenza T Vaccine against equine<br />

infuenza and clostridium<br />

botulinum<br />

390. Nobi — Vac MG inj. Vaccine against avian<br />

mycoplas-mosis, inac.<br />

391. NOBILIS CAV P4 Vaccine against infectious<br />

avian anaemia<br />

Pharmaceutical<br />

form<br />

Strength<br />

Sol. 5 g/100 ml,<br />

0,5 g/100 ml<br />

5+100+200ml+1+5l<br />

Ung. 0,25 g,<br />

0,1 g,<br />

1g<br />

10 ml<br />

Susp. Newcastle disease virus >10 9<br />

EID 50/ml<br />

500 ml<br />

Marketing<br />

authorisation holder<br />

Ceva Sante Animale<br />

Vet Prom Ltd.<br />

Fort Dodge Animal<br />

Health<br />

Susp. 1 ml Intervet International<br />

Susp. 500 ml Intervet International<br />

Lyoph. vac. CAA virus >3.0 log 10TCID 50<br />

/dose<br />

500 + 1000 + 2500 + 5000 +<br />

10000 doses<br />

392. NOBILIS FC inac Vaccine against pasteurellosis Susp. Pasteurella multocida, serotipes<br />

1, 2, 3, 4, 5, at least 5log 2 HI<br />

units/0.25 ml<br />

1000 doses<br />

393. Nobilis IB 4-91 Avian Infectious Bronchitis<br />

Vaccine, Living<br />

394. NOBILIS IB MA5, Avian Infectious Bronchitis<br />

Vaccine, Living<br />

395. Nobilis Ma5+Hitchner Newcastle Disease and Avian<br />

Infectious Bronchitis Vaccine,<br />

Living<br />

396. Nobilis SG 9R Vaccine against hen<br />

salmonellosis<br />

397. NOBILIS® EDS Egg-drop Syndrome 76<br />

(Adenovirus) Vaccine<br />

398. NOBILIS® IB+ND+EDS Newcastle Disease, Egg-drop<br />

Syndrome and Avian<br />

Infectious Bronchitis Vaccine<br />

3.6 log 10 EID 50 of Infectiuos<br />

Bronchitis virus<br />

500 + 1,000 + 2,500 + 5,000<br />

+ 10,000 doses<br />

Lyoph. vac. Infectious bronchitis virus >3.0<br />

log 10 EID 50/dose<br />

3.0 log EID 50 of infectiuos<br />

bronchitis,<br />

6.0 log EID 50 of Newcastle<br />

disease virus<br />

1,000 doses<br />

2×10 7 CFU of Salmonella<br />

gallinarum<br />

500 + 1,000 doses.<br />

Susp. Inactivated EDS'76 virus —<br />

‡6.5 log 2 HI units/dose<br />

1000 doses<br />

Susp. Inactivated IB virus ‡6 log 2 HI<br />

units/dose; Inactivated ND<br />

virus — ‡4 log 2 HI units per<br />

1 /50 dose or ‡50 PD 50<br />

units/dose; Inactivated EDS'76<br />

virus — ‡6.5 log 2 HI<br />

units/dose<br />

1000 doses<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

399. Nobi-Porvac Aujeszky Aujesky's Disease Vaccine Susp. 10 + 50 + 100 doses Intervet International<br />

400. Nobi-Porvac Parvo pro inj. Porcine Parvovirus Vaccine,<br />

Inactivated<br />

401. Nobi-Vac AR-T inj. Vaccine against porcine<br />

atrophic rhinits<br />

402. Nobi-Vac DHP+L Vaccine against canine<br />

hepatitis, parvovirosis and<br />

distemper<br />

Susp. 10 + 25 doses Intervet International<br />

BV<br />

Susp. 20+50 ml Intervet International<br />

Liof. vac. 10 + 50 doses Intervet International


EN<br />

422 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

403. Nobi-Vac DHPPi inj. Canine distemper virus,<br />

Canine adenovirus,<br />

Canine parvovirus,<br />

Canine parainfluenza virus<br />

404. Nobi-Vac FC inj. (NOBILIS FC<br />

inac)<br />

Pharmaceutical<br />

form<br />

Strength<br />

Susp. 10 3 TCID 50,<br />

10 3 pfu,<br />

10 7 TCID 50,<br />

>10 5 pfu/dose<br />

1ml<br />

Marketing<br />

authorisation holder<br />

Intervet International<br />

Vaccine against pasteurellosis Susp. 0.5 l Intervet<br />

International.<br />

405. Nobi-Vac L susp. Vaccine against leptospirosis Susp. 1 ml Intervet International<br />

406. NOBIVAC PARAMYXO Avian paramyxovirosis vaccine Susp. Paramyxovirus, strain P 3G, at<br />

least 5log 2 HI units/0.25 ml<br />

20 + 50 + 250 ml<br />

407. Nobi-Vac Parvo-C pro inj. Parvovirus Liof. vac. 10 7 TCID 50<br />

10 + 50 doses<br />

408. Nobi-Vac porcoli Vaccine against piglet<br />

enterotoxemia<br />

409. Nobi-Vac Puppy DP inj. Canine distemper virus,<br />

Canine parvovirus<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

Sol. 20 + 50 ml Intervet International<br />

10 7 TCID 50,<br />

10 5 TCID 50/dose<br />

1ml<br />

Intervet International<br />

410. Nobi-Vac rabies pro inj. Rabies vaccine Susp. 1 + 10 doses Intervet International<br />

411. Nobi-Vac Tricat pro inj. Vaccine against feline<br />

rhinotracheitis an coliviral<br />

infection<br />

412. NOBIVAC® RL, vakcina Leptospira interrogans ser.<br />

Canicola<br />

Leptospira interrogans ser.<br />

Icterohaemorrhagiae<br />

Rabies virus cloned out of<br />

strain Pasteur RIVM<br />

413. Nobi-Vak IB+G+ND pro inj. Avian Infectious Bronchitis,<br />

Bursal Disease and Newcastle<br />

Disease Vaccine, Inactivated<br />

414. Nobi-Vak Reo+IB+G+ND, pro<br />

inj.<br />

Avian Reovirus Infection,<br />

Infectious Bronchitis, Bursal<br />

Disease and Newcastle Disease<br />

Vaccine<br />

Susp. 1 ml Intervet International<br />

Sol. >40 hamster PD 80<br />

>40 hamster PD 80<br />

>3 I.U.<br />

1ml<br />

415. NOROCILLIN Procaine penicillin Susp. 300 mg<br />

50 + 100 ml<br />

416. Noroclox, susp. Cloxacillin benzathine Susp. 500 mg<br />

4,5 g<br />

417. Norodine 24, sol. inj. Trimethoprim,<br />

Sulphadiazine<br />

418. NORODINE EQUINE PASTE Trimethoprim,<br />

Sulphadiazine<br />

Intervet International<br />

B.V.<br />

Susp. 1,000 doses Intervet International<br />

Susp. 1,000 doses Intervet International<br />

Sol. 40 mg/ml,<br />

200 mg/ml<br />

50 + 100 ml<br />

Paste 58 mg,<br />

288.3 mg<br />

45 g<br />

419. NOROMECTIN DRENCH Ivermectin Sol. 0.8 mg/ml<br />

1+2,5+5 l<br />

420. NOROMECTIN INJECTION Ivermectin Sol. 10 mg/ml<br />

50+100+250+500 ml<br />

421. Nortril 5 % inj. Norfloxacin Sol. 50 mg<br />

100 ml<br />

422. Nortril for oral administr. Norfloxacin Sol. 100-200 mg<br />

200 + 500 + 1,000 ml<br />

NORBROOK<br />

Laboratories Limited<br />

Norbrook<br />

Laboratories Ltd.<br />

Norbrook<br />

Laboratories Ltd.<br />

NORBROOK<br />

Laboratories Limited<br />

Norbrook<br />

Laboratories Limited<br />

Norbrook<br />

Laboratories Limited<br />

Bremer Pharma<br />

Bremer Pharma


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 423<br />

No. Commercial name General name<br />

423. Novasul Noramidopyrinium<br />

methansulfonat sodium<br />

424. NUTRICIN SULFA 140 Oxytetracycline,<br />

Neomycin,<br />

Sulfadimidine sulfate<br />

Pharmaceutical<br />

form<br />

Sol. 500 mg<br />

100 ml<br />

Strength<br />

Powder 60 g,<br />

30 g,<br />

25 g/kg<br />

200g+1+25kg<br />

Marketing<br />

authorisation holder<br />

C. Richter Gesmbh<br />

Co KG<br />

PLIVA D. D. B.V.<br />

425. Nutril SE, pulv. Vitamines and amino acides Powder 100 g +1+25kg LekPharmaceutical<br />

and Chemical<br />

Company<br />

426. NUTRIVAL Calcium iodate<br />

Choline chloride<br />

Cobalt carbonate<br />

Copper sulphate<br />

Iron sulphate<br />

Folic acid<br />

Magnesium sulphate<br />

Manganese sulphate<br />

Zinc sulphate<br />

Vitamin A<br />

Vitamin D 3<br />

Vitamin E (acetate)<br />

Vitamin K 3<br />

Vitamin B 1<br />

Vitamin B 2<br />

Vitamin B 5 (Calcium<br />

pantothenate)<br />

Vitamin B 6<br />

Vitamin B 12<br />

Vitamin PP<br />

Vitamin H<br />

Vitamin C<br />

Powder 50 mg<br />

17.5 g<br />

16.2 mg<br />

120 mg<br />

70 mg<br />

250 mg<br />

70 mg<br />

160 mg<br />

60 mg<br />

10 mln. IU<br />

3 mln. IU<br />

2.5 g<br />

4g<br />

5g<br />

500 mg<br />

5g<br />

2.5 g<br />

5mg<br />

2g<br />

5mg<br />

10 g/kg<br />

150 g+25 kg<br />

Laboratoires<br />

SOGEVAL<br />

427. OESTRADIOL BENZOATE 17 B-benzoate Sol. 0.2-1-5 mg/ml Intervet International<br />

B.V.<br />

428. Oestrophan, sol. inj. Cloprostenolum Sol. 250 mg/ml<br />

2ml<br />

429. OKSITOCINAS Oxytocinum Sol. 5-10 AU/ml<br />

50 ml<br />

430. OLIGOVIT Vitamin A as propionate<br />

Cholecalciferol (vit. D 3)<br />

Thiamine hydrochloride (vit.<br />

B 1)<br />

Riboflavine (vit. B 2) sodium<br />

phosphate<br />

Nicotinamide (vit. PP)<br />

Pyridoxine hydrochloride<br />

(vit.B 6)<br />

Cyanocobalamine (vit. B 12)<br />

Alpha tocoferol acetate (vit. E )<br />

D-panthenol<br />

Meso-inositol<br />

dl-Methionine<br />

Choline citrate<br />

Magnesium hypophosphite<br />

hexahydrate<br />

Cobalt chloride hexahydrate<br />

Cupric sulphate pentahydrate<br />

Sol. 50000 I.U<br />

25000 m I.U<br />

10000 mg<br />

0.056 mg<br />

5.000 mg<br />

1.0 mg<br />

0.010 mg<br />

4.000 mg<br />

2.000 mg<br />

2.000 mg<br />

5.000 mg<br />

5.000 mg<br />

1.0 mg<br />

0.020 mg<br />

0.100 mg<br />

100 ml<br />

431. OPTICLOX EYE OINTMENT Cloxacillin Benzoathine Ointm. 213 mg<br />

5ml<br />

Lečiva Ltd.<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

Kela Laboratoria<br />

N.V.<br />

NORBROOK<br />

Laboratories Limited


EN<br />

424 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

432. ORBENIN EDC Cloxacillin Benzathine<br />

equivalent to cloxacillin<br />

433. ORIGINAL NJP — LINIMENT Menthae arvensis aetheroleum<br />

Carbopol<br />

Cetostearyl alcohol<br />

434. OTIBIOVIN, Triamcinolonacetonid,<br />

Acidum salicylicum,<br />

Gentamycinsulphat<br />

435. Oticure Monosulfiram,<br />

Dexamethasone,<br />

Bacitracin,<br />

Polymixin B sulfate<br />

Amphocerin<br />

436. OVO-4 Inactivated infectious<br />

bronchitis virus<br />

Inactivated egg drop syndrome<br />

virus<br />

Inactivated Newcastle disease<br />

virus<br />

Inactivated swollen head<br />

syndrome virus<br />

437. OXINEOMICINA Neomycin sulphate<br />

Oxytetracycline HCl<br />

Pharmaceutical<br />

form<br />

Susp. 0.60 g/3.6 g<br />

3.6 g syr.<br />

Ointm. 0,33 g<br />

0,002 g<br />

0,05 g/1 g<br />

500 ml<br />

Sol. 0.5 mg,<br />

5 mg,<br />

2 mg/ml<br />

20 ml<br />

Susp. 50 mg,<br />

1 mg,<br />

500 IU,<br />

5000 IU,<br />

K 50 mg<br />

15 ml<br />

Strength<br />

Susp. ‡10 6.7 EID 50<br />

‡10 6.0 CCID 50<br />

‡10 8.0 EID 50<br />

‡10 5.0 CCID 50<br />

500+1000 doses<br />

powder 190 g<br />

190 g/1000 g<br />

0.1+1+5+25 kg<br />

438. Oxytetra 5-10% Oxytetracycline hydrochloride Powder 50-100 mg<br />

1kg<br />

439. OXYTETRACYCLIN 10 % Oxytetracycline hydrochloride Sol. 100 mg<br />

50+100+250 ml<br />

440. Oxytetracyclin 10% pro inj. Oxytetracyclini<br />

hydrochloridum<br />

441. Oxytetracycline 10 % Oxytetracycline Hydrochloride,<br />

Magnesium Chloride<br />

442. OXYTETRACYCLINE 10 % INJ. Oxytetracycline (as<br />

hydrochloride)<br />

443. Oxytetracycline 20 % L. A. Oytetracycline,<br />

Magnesium chloride<br />

444. OXYTETRACYCLINE 20 %<br />

L.A. INJ.<br />

Sol. 10 g/100 ml<br />

100 ml<br />

Sol. 100 mg,<br />

50 mg<br />

100 ml<br />

Sol. 100,0 mg/ml<br />

100 ml<br />

Sol. 200 mg,<br />

50 mg<br />

100 ml<br />

Oxytetracycline Sol. 200,0 mg/ml<br />

100 ml<br />

445. Oxytocin pro inj. Oxytocinum Sol. 10 TV/ml<br />

10 + 50 ml<br />

446. Oxyvet Oxytetracyclinum<br />

hydrochloridum<br />

Aerosol 0.05 g<br />

50 + 100 ml<br />

Marketing<br />

authorisation holder<br />

Pfizer Oy Animal<br />

Health<br />

Nardos A/S<br />

Bioveta Plc.<br />

Intervet Intern.<br />

Merial<br />

Investigaciones<br />

Quimicas y<br />

Farmaceuticas, S.A.<br />

Biowet-Gorzow<br />

Farvet Laboratories<br />

B.V.<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Alfasan International<br />

B. V.<br />

Dutch Farm<br />

Veterinary<br />

Pharmaceuticals B.V.<br />

Alfasan International<br />

B. V.<br />

Dutch Farm<br />

Veterinary<br />

Pharmaceuticals B.V.<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Tarchominskie<br />

Zaklady<br />

Farmaceutyczne<br />

‘Polfa’Spolka Akcyjna<br />

447. Paracillin SP pulv. Amoxicillin trihydrate Powder 812 mg/g Intervet International<br />

448. PARISPULSIN Ergonovine tartrate<br />

Estradiol benzoate<br />

Emuls. 4 mg<br />

10 mg/10 ml<br />

10 ml syr.<br />

Industrial<br />

Veterinaria, S.A. —<br />

Invesa


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 425<br />

No. Commercial name General name<br />

449. Parvigen Attenuated canine parvovirus<br />

(Cornell strain CPV/780916-<br />

115P)<br />

450. PARVOSIN inj. sic. ad us. vet. Porcine Parvovirus Vaccine,<br />

Inactivated<br />

451. Pederipra Spray Chlortetracycline<br />

hydrochloride<br />

452. Pen Strep, susp. Procainpenicillin,<br />

Dihydrostreptomycin sulfate<br />

453. PENIKAN P Procaine benzylpenicillin<br />

Kanamycin sulphate aeq<br />

Prednisolone<br />

454. Pen-Strep 40, susp. inj. Benzylpenicillin Procain,<br />

Dihydrostreptomicin<br />

Pharmaceutical<br />

form<br />

Susp. ‡104 TCID50<br />

1 ml.<br />

Strength<br />

Lyoph. vac. Parvovirus of pigs inactivated<br />

30 ml<br />

Aerosol 20 mg/ml<br />

200 ml<br />

Susp. 200 mg/ml,<br />

250 mg/ml<br />

50 + 100 ml<br />

Susp. 300000 I.U<br />

100 mg<br />

20 mg/10 ml<br />

4+20 syr.<br />

Susp. 200 000 UI/ml,<br />

250 mg/ml<br />

100 ml<br />

455. Perlutex tablets Medroxyprogesterone acetate Tabl. 5 mg<br />

20 + 50 tabl.<br />

456. PESTORIN inj. ad us. vet. Vaccine against rabbit pest Susp. Virus 0.0458 ml/ml<br />

20 + 50 ml<br />

457. PESTORIN MORMYX inj. sic.<br />

ad us. vet.,<br />

Vaccine against rabbit pest and<br />

myxomatosis<br />

458. PG 600 pulv. freeze-dried Serum gonadotrophin,<br />

Chorionic gonadotrophin<br />

459. PGF VEYX® Cloprostenol sodium<br />

Chlorocresole<br />

460. PGF VEYX® FORTE Cloprostenol sodium<br />

Chlorocresole<br />

461. PHARMASIN® 50,<br />

PHARMASIN® 200<br />

Susp. Rabbit pest virus 128 HA,<br />

Myxomatosis virus 1×10 4<br />

TKID 50/ml<br />

20 ml<br />

Freeze dried<br />

pulv.<br />

400 AU/dose,<br />

200 AU/dose<br />

Sol. 92 µg<br />

1 mg/ml<br />

50 ml<br />

Sol. 263 µg<br />

1 mg/ml<br />

10 ml<br />

Tylosin Sol 50 mg or 200 mg/ml<br />

25+50 ml<br />

462. PHARMASIN® PULVIS Tylosin tartrate powder 118.1 g/200 g<br />

100+200 g<br />

463. Pyanosid pro inj. Lincomycini hydrochloridum,<br />

Spectinomycini sulfas<br />

Sol. 5,67 g,<br />

15,12 g/100 ml<br />

100 ml<br />

464. Pillkan 5, Pillkan 20 Megestrol acetate Pieces 5.25 mg<br />

8 pieces<br />

465. PIRITEL® Gentamicin (in the form of<br />

sulphate) Pyrantel tartrate<br />

466. Pyrodalbeen Hydrolyzed casein,<br />

Methenamine,<br />

Iodine salicylic acid,<br />

Manganum dioxydatum,<br />

Arecolin hydrobromida<br />

467. Pneumodog, vaccine pro inj. Bordetella bronchiseptica,<br />

Parainfluenza type 2 virus<br />

powder 12.5 g/100 g<br />

20+100+1000 g<br />

Sol. 2,65 g/100 ml,<br />

15 g/100 ml,<br />

2,5 g/100 ml,<br />

0.06 g/100 ml,<br />

0.5/100 ml<br />

100 ml<br />

Freeze dried<br />

vac.<br />

10 9 CFU,<br />

32 HAU/ml<br />

Marketing<br />

authorisation holder<br />

Virbac S.A.<br />

Bioveta Plc.<br />

Laboratorios Hipra<br />

Norbrook<br />

Laboratories Ltd.<br />

Kela Laboratoria N. V.<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Leo Pharmaceutical<br />

Products Ltd.<br />

Bioveta Plc.<br />

Bioveta Plc.<br />

Intervet International<br />

Veyx-Pharma GmbH<br />

Veyx-Pharma GmbH<br />

Balkanpharma-<br />

Razgrad AD<br />

Balkanpharma-<br />

Razgrad AD<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Ceva Sante Animale<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d.d.<br />

Atarost,<br />

Rhone Merieux


EN<br />

426 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

468. Polifungivet 2% sol. Clotrimazolum Sol. 2 g/100 ml<br />

500 + 1 000 ml<br />

469. Polyspezifisches Testreagens<br />

Anti-Shigella, Monospezifische<br />

Testseren ‘Anti-Shigella’ —<br />

Testiniai serumai ‘Anti-Shigella’<br />

Monospecific and polyspecific<br />

sera for diagnosis of Shigella<br />

470. Polisulfalent, sol inj. Sulfadimethoxinum,<br />

Sulfadimidinum,<br />

Sulfathiazolum<br />

471. Polyverkan Niclosamide,<br />

Oxybendazole<br />

472. PORCILIS BPM Bordetella bronchiseptica<br />

Pasteurella multocida type A<br />

Pasteurella multocida type D<br />

Mycoplasma hyopneumoniae<br />

473. PORCILIS M Inactivated Mycoplasma<br />

hyopneumoniae, strain 11<br />

474. PORCILIS® APP Porcine Actinobacillosis<br />

Vaccine<br />

Strength<br />

Marketing<br />

authorisation holder<br />

Polfa Grodzisk<br />

Susp. Institut fur<br />

Immunpraparate und<br />

Nahrmedien GmbH<br />

Berlin ‘SIFIN’<br />

Sol. 7,2 g/100 ml,<br />

2,78 g/100 ml,<br />

1,25 g/100 ml<br />

250 ml<br />

Pieces 200 mg,<br />

40 mg<br />

8 pieces<br />

Susp. min. 2.0×10 10 KFV<br />

min. 1.0×10 10 KVF<br />

min 1.0×10 10 KVF<br />

min. 1.0 RP<br />

50+100 ml<br />

Susp. relative potency > 1<br />

50+100 ml<br />

Susp. Antigen concentrate<br />

(containing 50 units ApxI,<br />

25-78 units ApxII, 50 units<br />

ApxIII and 50 units OMP) —<br />

600 mg/dose<br />

10 + 25 doses<br />

475. PORCILIS® ERY, Swine Erysipelas Vaccine Susp. Erysipelothrix rhusiopathiae<br />

concentrate (‡ 50 IU /dose<br />

25 doses<br />

476. PORCILIS® ERY+PARVO Swine Erysipelas<br />

Parvoviral infection Vaccine<br />

477. POULVAC AE Infectious Avian<br />

Encephalomyelitis Vaccine<br />

Susp. Porcine Parvovirus ‡9 log 2 HI<br />

units; Inactivated E. rhusiopathiae,<br />

‡50 IU/dose<br />

10 + 25 + 50 + 125 doses<br />

Lyoph. vac. Avian encephalomyelitis virus<br />

‡10 6,1 EID 50/dose<br />

1000 doses<br />

478. POULVAC CHICK-N-POX T.C. Fowl Pox Vaccine, Living Lyoph. vac. Fowl pox virus — ‡10 5,3<br />

TCID 50/1000 doses<br />

500 + 1000 does<br />

479. POULVAC IB PRIMER Avian Infectious Bronchitis<br />

Vaccine<br />

480. POULVAC ILT Fowl Infectious<br />

Laryngotracheitis Vaccine<br />

481. POULVAC MAREK CVI +<br />

DILUENT<br />

Lyoph. vac. Infectious bronchitis virus<br />

‡10 3 EID 50/dose<br />

2500 + 5000 doses<br />

Susp. Fowl infectious laryngotracheitis<br />

virus — 10 5,5<br />

EID 50/1000 doses<br />

1000 doses<br />

Marek's Disease Vaccine Lyoph. vac. Marek's disease virus 10 6<br />

TCID 50/1 l<br />

200 + 1000 doses<br />

482. POULVAC MAREK HVT Marek's Disease Vaccine Lyoph. vac. Herpes virus of turkeys 10 6<br />

pfu<br />

1000 doses<br />

483. POULVAC ND HITCHER B 1 Newcastle Disease Vaccine Lyoph. vac. Newcastle disease virus, strain<br />

Hitchner B 1 not less than 10 5.5<br />

EID 50/dose<br />

1000 + 2500 + 5000 doses<br />

Biowet Pulawy<br />

Ceva Sante Animale<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

Intervet International<br />

B.V.<br />

Fort Dodge Animal<br />

Health<br />

Fort Dodge Animal<br />

Health<br />

Fort Dodge Animal<br />

Health<br />

Fort Dodge Animal<br />

Health<br />

Fort Dodge Animal<br />

Health<br />

Fort Dodge Animal<br />

Health<br />

Fort Dodge Animal<br />

Health


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 427<br />

No. Commercial name General name<br />

484. POULVAC NEW BRONZ Newcastle Disease and Avian<br />

Infectious BronchitisVaccine,<br />

Inactivated<br />

Pharmaceutical<br />

form<br />

Strength<br />

Susp. Newcastle disease virus ‡10 9<br />

TCID 50; Infectious bronchitis<br />

virus ‡10 8 EID 50/dose<br />

1000 doses<br />

485. POULVAC PAST. M. Vaccine against pasturellosis Susp. Pasteurella multocida ‡12×10 8<br />

org./dose<br />

1000 doses<br />

Marketing<br />

authorisation holder<br />

Fort Dodge Animal<br />

Health<br />

Fort Dodge Animal<br />

Health<br />

486. POULVAC TRI-REO Avian Reo-virus vaccine Susp. 1000 doses Fort Dodge Animal<br />

Health<br />

487. POULVAC VA Vaccine against tenosynovitis Susp. Tenosynovitis virus — 10 6,2<br />

EID 50/1000 doses<br />

1000 doses<br />

488. PRATEL® tablets Praziquantel,<br />

Pyrantel embonate<br />

Tabl. 50.0 mg;<br />

144.0 mg/tabl.<br />

10 tabl.<br />

489. PREDNISOLON 1 % Prednisolon-21-acetat Sol. 10 mg/ml<br />

100 ml<br />

490. Prednisolon-acetat 1 % Prednisolon-21-acetat,<br />

Sodium chloride<br />

Sol. 10 mg,<br />

9mg<br />

100 ml<br />

491. Prednisolone 1 % Prednisolon acetate Sol. 10 mg<br />

100 ml<br />

492. Primabel LA susp. pro inj. Amoxycillini trihydras Susp. 172,2 mg/ml<br />

100 ml<br />

493. Primodog, vaccine pro inj. Canine Parvovirus Vaccine Susp. Canine parvovirus 10 5.5<br />

CCID 50,<br />

100 doses<br />

494. Prosolvin 7,5 pro inj. Luprostiolum Sol. 7,5 mg/ml<br />

10 + 20 ml<br />

495. PROVAC 3 Infectious Bursal Disease,<br />

Newcastle Disease and Avian<br />

Infectious Bronchitis Vaccine<br />

496. PROVAC 4 Infectious Bursal Disease,<br />

Newcastle Disease, Reovirus<br />

and Avian Infectious<br />

Bronchitis Vaccine<br />

497. Pruritex Kanamycin sulfate,<br />

Dexamethasone,<br />

Mepyramine maleate,<br />

Zinc oxyde<br />

Susp. Bursal disease virus >10 6,5<br />

EID 50; Newcastle disease virus,<br />

>10 9 TCID 50; Bronchitis virus<br />

>10 8 EID 50/dose<br />

500 ml<br />

Susp. Bursal disease virus >10 6,5<br />

EID 50; Newcastle disease virus<br />

>10 9 TCID 50; Bronchitis virus<br />

>10 8 EID 50; Reovirus strain<br />

>10 7,4 EID 50; Reovirus strain<br />

>10 7,4 EID 50/ml<br />

500 ml<br />

1.5 mg,<br />

0,1mg,<br />

0.4 mg,<br />

25 mg/g<br />

60 + 125 g<br />

498. Pullorum antigen Nobilis Salmonella pullorum antigen Susp. 2,5%<br />

10 ml<br />

499. Pulmotil 200 Premix Tilmicosin Powder 200 g<br />

10 kg<br />

500. PVP Iodine spray ad us. vet. Polivinil pirolidon jod Sol. 10 g/100 ml<br />

100 ml<br />

501. Quadractin Newcastle Disease, Infectious<br />

Bursal Disease, Reovirus<br />

Disease and Avian Infectious<br />

Bronchitis Vaccine<br />

Susp. IB virus, ND virus, IBD virus<br />

and Reo virus- 32 %<br />

250-500 ml<br />

Fort Dodge Animal<br />

Health<br />

Lek Pharmaceutical<br />

and Chemical<br />

Company d. d.<br />

BELA-PHARM<br />

GmbH & CO.KG<br />

Atarost GmbH & Co.<br />

Bremer Pharma<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Rhone Merieux<br />

Intervet International<br />

Fort Dodge Animal<br />

Health<br />

Fort Dodge Animal<br />

Health<br />

Alfasan International<br />

B. V.<br />

Intervet International<br />

B.V.<br />

Elanco Animal<br />

Health, Eli Lilly<br />

Gmbh<br />

Bioveta Plc.<br />

Abic Ltd.


EN<br />

428 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

502. Quadricat vaccine pro inj. Feline Panleukaemia,<br />

Calicivirus, Rabies and Herpes<br />

Vaccine<br />

Pharmaceutical<br />

form<br />

Freeze dried<br />

vac.<br />

503. QUADRISOL® 5 Vedaprofen Gel 5,0 mg/ml<br />

15 + 30 ml<br />

504. Rabigen mono inactivated rabies suspension<br />

(VP12 strain)<br />

Susp. 1 IU<br />

1 ir 10 doziu˛<br />

Strength<br />

Panleucopenia 10 3 CCID 50,<br />

Rabies visus 1 UI, Herpes virus<br />

150 UIDR, Calicivirus antigen<br />

25 µg/ml<br />

Marketing<br />

authorisation holder<br />

Rhone Merieux<br />

Intervet International<br />

B.V.<br />

Virbac S.A.<br />

505. Rabisin, vaccine pro inj. Rabies Vaccine, Inactivated Susp. 1 ml + 10 ml Rhone Merieux<br />

506. RABVAC 1 Rabies Veterinary Vaccine,<br />

Inactivated<br />

507. RABVAC 3 (TRIMUNE) Rabies Veterinary Vaccine,<br />

Inactivated<br />

508. Reo Vaccine Nobilis, strain<br />

1133<br />

Avian Reovirus Infection<br />

Vaccine<br />

509. RESPISURE® Inactivated whole cell culture<br />

of Mycoplasma<br />

hyopneumoniae<br />

510. RIFAMYCIN 100 —<br />

Mastitisinjektor<br />

511. RIMADYL TABLETS 20 mg,<br />

RIMADYL TABLETS 50 mg<br />

Rifamycine sodium.<br />

Sodium ascorbate<br />

512. RINGERIO solution Sodium chloride<br />

Potassium chloride<br />

Calcium chloride<br />

Natrium hidrocarbonate<br />

513. RINGERIO-LOKO SOLUTION Sodium chloride<br />

Potassium chloride<br />

Calcium chloride<br />

Sodium hidrocarbonate<br />

Susp. Rabies virus 0,799 ml/ml<br />

1+10ml<br />

Susp. Rabies virus 0,07198 ml/ml<br />

1+10ml<br />

Susp. Reovirus strain 1133 10 3.1<br />

TCID 50<br />

1,000 doses<br />

Emuls. 5×10 8 -5×10 9 CCU<br />

10+50+250 doses<br />

Emmulse 103.2 mg,<br />

40 mg<br />

Carprofen Tab. 20.0 mg or 50.0 mg/150 mg<br />

20 tab.<br />

Sol. 9.0 g<br />

0.2 g<br />

0.2 g<br />

0.2 g<br />

50+100+200+250+450+<br />

500 ml<br />

Sol. 8.0 g<br />

0.2 g<br />

0.2 g<br />

0.2 g<br />

200 ml<br />

514. Rismavac Nobilis inj. Marek's Disease Vaccine Susp. Herpesvirus strain CV1988<br />

1,000 PFU<br />

1,000 + 2,000 doses<br />

515. ROMEDAT AD3E (oleos) Retinolpalmitat,<br />

Colecalciferol,<br />

Tocopherolacetat<br />

Susp. 8.83 mg,<br />

7.5 mg,<br />

5 mg/ml<br />

516. Romedat D 3 Forte Cholecalciferol Susp. 50 mg<br />

100 ml<br />

517. ROTA-TS 100, ROTA-TS 500 Trimethoprim,<br />

Sulfadimidine<br />

518. Rumex Mixture of minerals and<br />

organic compounds<br />

519. Ruminatorio H, pulv. Calcium carbonate,<br />

Calcium propionate,<br />

Rumen flora,<br />

Carbachol<br />

Tabl. 16.70-83.30 mg,<br />

83.30-416.70 mg/tabl.<br />

10 tabl.<br />

Fort Dodge Animal<br />

Health<br />

Fort Dodge Animal<br />

Health<br />

Intervet International<br />

Pfizer Animal Health<br />

Group Pfizer Oy<br />

ATAROST GmbH &<br />

Co.<br />

Pfizer Oy Animal<br />

Health<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

Intervet International<br />

ATAROST GmbH &<br />

Co.<br />

Atarost GmbH & Co.<br />

CHASSOT AG<br />

Powder 3,5 kg Suomen Rehu Ltd.<br />

Powder 50 g/100 g,<br />

20 g/100 g,<br />

10 g/100 g,<br />

0,003 g<br />

520. SAG 1 RABIES VACCINE Rabies Vaccine for Foxes Bait Rabies virus suspension in 10 8<br />

TCID 50/dose<br />

1.8 ml/bait<br />

Laboratorios Hipra<br />

Virbac S.A.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 429<br />

No. Commercial name General name<br />

521. Salenvac ad us. vet. Salmonella enteritidis Vaccine,<br />

Inactivated<br />

522. SALMABIC S. enteritidis strain C8<br />

S. enteritidis strain B3<br />

S. typhimurium strain 2(+4)<br />

523. Salmonella- Diagnostik‘Antisalmonella’<br />

(Testreagenzien,<br />

Enteroclone, Testseren,<br />

Testantigene, Kontrollseren)<br />

Salmoneliu˛ diagnostikumai<br />

‘Anti Salmonella’(Regentai,<br />

klonai, antigenai, serumai<br />

kontroliniai serumai)<br />

524. Sanoderm Neomycin sulfate<br />

Dexamethasone<br />

Pharmaceutical<br />

form<br />

Strength<br />

Susp. Salmonella enteritidis<br />

2×10 9 /ml<br />

Emuls. 1×10 8 CFU/dose<br />

1×10 8 CFU/dose<br />

1×10 8 CFU/dose<br />

500+1000 doses<br />

Marketing<br />

authorisation holder<br />

Hoechst Roussel<br />

Limited<br />

Abic Ltd.<br />

Salmonella Diagnostic Kit Susp. Institut fur<br />

Immunpraparate und<br />

Nahrmedien GmbH<br />

Berlin ‘SIFIN’<br />

12.5 mg,<br />

0,2 mg/g<br />

60 + 100 + 1000 g<br />

525. Sanolin pro inj. Lincomycini hydrochloridum Sol. 113,4 mg/ml<br />

100 ml<br />

Alfasan International<br />

B. V.<br />

Bremer Pharma<br />

GmbH<br />

526. SEDALIN 7-35 mg Acepromazine maleate Tabl. 9.50-47.50 mg/tabl. CHASSOT AG<br />

527. SEDALIN Gel Acepromazine maleate Gel 475 mg/10 ml CHASSOT AG<br />

528. SEDIVAN® 0,1 % Romifidine hydrochloride Sol. 1 mg/100 ml<br />

20 ml<br />

529. Seled hydrosol Sodium selenite,<br />

Alpha tcopheryl Acetate,<br />

Cholecalciferol,<br />

Linopharm<br />

Sol. 0.06 g/100 ml,<br />

2.5 g/100 ml,<br />

0.063 g/100ml<br />

15 g/100 ml<br />

200 + 1000-2000 ml<br />

530. SYNTARPEN Cloxacillin sodium Susp. 0.5 g<br />

10 g syr.<br />

531. SYNTARPEN PROLONGATUM Cloxacillin benzathine Susp. 0.6 g<br />

10 g syr.<br />

532. Synulox Lactating Cow Amoxycillin trihydrate,<br />

Potassium clavulanate,<br />

Prednisolone<br />

533. SYNULOX tabl 50 mg,<br />

SYNULOX tabl 250 mg,<br />

SYNULOX tabl 500 mg,<br />

534. Skysta gyva virusine˙ vakcina iš<br />

kalakutu˛ HERPES viruso NG 1<br />

kamieno nuo Mareko ligos<br />

Amoxicillin<br />

Clavulanic acid<br />

Marek's Disease Vaccine,<br />

Living<br />

Susp. 200 mg,<br />

55 mg,<br />

10 mg<br />

3g<br />

Tabl. 22.86 %<br />

5.71 %<br />

10+100+250+500 tabl.<br />

Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

Vetprom Ltd<br />

Biowet-Puławy Sp.<br />

z o.o.<br />

Biowet-Puławy Sp.<br />

z o.o.<br />

Pfizer Oy<br />

Pfizer Oy Animal<br />

Health<br />

Susp. 1100 PFU/dose LITHUANIAN<br />

VETERINARY<br />

INSTITUTE<br />

535. SOGECYCLINE Tetracycline (as hydrochloride) powder 50.0 g/100 g<br />

100+200 g+1+5+10 kg<br />

536. SOGECOLI Colistin Sol. 200 MIU/100 ml SOGEVAL<br />

537. Sol. Gentamycini 5% pro inj. Gentamycini sulphas Sol. 85 mg/ml<br />

100 m<br />

538. Sol. Gentodiar gel Gentamycini sulfas Sol. 5 mg/ml<br />

175 ml<br />

539. SOLUTIO NATRII CHLORIDI<br />

ISOTONICA<br />

Sodium chloride Sol. 0.9 g<br />

50+100+200+250+450+500<br />

Laboratoires Sogeval<br />

Bela-Pharm GmbH<br />

Co.<br />

Intervet International<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’


EN<br />

430 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

540. Solutio tetraviti injectionibus Vitamin A,<br />

Vit. D,<br />

Vit. E,<br />

Vit. F<br />

541. SOLUTION NOVOCAINI PRO<br />

INJECTIONIBUS<br />

542. SOLUTIONES NATRIUM<br />

CHLORIDUM<br />

HIPERTONICUM<br />

543. Solvimin pulv. Vitamini A,<br />

Vitamini D 3,<br />

Vitamini E,<br />

Vitamini B 1,<br />

Vitamini B 2,<br />

Vitamini B 6,<br />

Vitamini B 12,<br />

Vitamini PP,<br />

Vitamini K,<br />

Sodium ascorbate,<br />

Folic acid<br />

Pharmaceutical<br />

form<br />

Sol. 50000 IU/ml,<br />

25000 IU/ml,<br />

20 mg/ml,<br />

5 mg/ml<br />

100 ml<br />

Strength<br />

Novocainum Sol. 5.0 or 10.0 g or 20.0 g/l<br />

10+20+30+50+200 ml<br />

Sodium chloride Sol. 5 %, 10 % or 20 %<br />

200 ml<br />

Powder 2 000 000 UI,<br />

1 000 000 UI,<br />

525 mg,<br />

150 mg,<br />

343 mg,<br />

200 mg,<br />

0,75 mg,<br />

1 800 mg,<br />

336 mg,<br />

2 000 mg,<br />

40 mg<br />

100 g + 500 g + 1 kg<br />

544. Spasmotitrat pro inj. Denoverin hydrochlorid Sol. 400 mg/10 ml<br />

50 ml<br />

545. Spectabilin Lincomycinhydrochloride<br />

Spectinomycin sulfate<br />

546. SPORYL OINTMENT Eugenal<br />

Cetrimide<br />

547. STREPDIPEN®-SUSPENSION,<br />

ölig<br />

Benzylpenicillin-Benzathin<br />

Benzylpenicillin-Procain<br />

Dihydrostreptomycinsulfat<br />

548. Strepto-Penicillin 45 Mega Procain-benzylpenicillin,<br />

Dihydrostreptomycin sulfat,<br />

Procainehydrochlorid<br />

549. STRESNIL Azaperonum<br />

Acidum tartaricum<br />

550. Suibicol Zincum ohydatum<br />

Sulfaguanidinum<br />

551. Suiferrovit pro inj. Ferrum dextran,<br />

Trace elements, Vitamines,<br />

Swine blood serum<br />

56.7 mg,<br />

151.2 mg<br />

100 ml<br />

Ointm. 20 mg<br />

12 mg/g<br />

100 g<br />

Susp. 9,167 g<br />

3,0 g<br />

19,640 g/100 g<br />

100 ml<br />

Sol. 200 mg,<br />

329 mg,<br />

20 mg<br />

100 ml<br />

Sol. 40 mg,<br />

14 mg/1 g<br />

Powder 300 g,<br />

200 g/kg<br />

1+10kg<br />

Sol. 7 g<br />

250 ml<br />

552. SULFATYF PLUS Sulfachloropyrazinum Natrium Powder 11,0 g<br />

50+100+500 g<br />

553. SULPHIX N Sulfadoxin,<br />

Trimethoprim<br />

554. Sulphix pro inj. Trimethoprimum,<br />

Sulphamethoxazolum<br />

Sol. 200.0 mg,<br />

40.0 mg/ml<br />

100 ml<br />

Sol. 40 mg,<br />

200 mg/ml<br />

100 ml<br />

Marketing<br />

authorisation holder<br />

JSC Kyiev Vitamin<br />

Enterprise<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

KRKA<br />

Veyx-Pharma GmbH<br />

Bremer Pharma<br />

C. Richter GesmbH<br />

&CoKG<br />

Serum-Werk<br />

Bernburg AG<br />

Atarost GmbH & Co.<br />

JANSSEN<br />

PHARMACEUTICA<br />

N.V.<br />

Biowet Pharma<br />

ceutical Company<br />

Inc.<br />

Biowet Pulawy<br />

Drwalewskie zakłady<br />

przemysłu<br />

Bioweterynaryjnego<br />

Spólka Akcyjna<br />

Bela — Pharm<br />

GmbH & Co. KG<br />

Bela — Pharm<br />

GmbH Co.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 431<br />

No. Commercial name General name<br />

555. Supravitaminol liquid Vit. A,<br />

Vit. D 3,<br />

Vit. E,<br />

Vit. B6,<br />

Vit. PP,<br />

Vit. B2,<br />

Vit. H,<br />

Methionine acetil,<br />

Calcium D panthothenate<br />

556. Surolan susp. Miconazoli nitratis,<br />

Prednisoloni acetatis<br />

Polymyxini B sulfatis<br />

557. SUVAXYN GESTAFEND 7B Porcine Parvovirus, Swine<br />

Erysipelas and Leptospirosis<br />

Vaccine<br />

558. SUVAXYN M.hyo Vaccine against Swine<br />

mycoplasmosis<br />

559. Špagyrine˙s esensijos 18 —<br />

23 Vol — %<br />

560. Tabulettae cobalti chloridi et<br />

natrii chloridi<br />

Pharmaceutical<br />

form<br />

Sol. 5 MIU,<br />

1 MIU,<br />

0.5 g,<br />

0.4 g,<br />

1g,<br />

0.02 g,<br />

0.001 g,<br />

2g,<br />

2.5 g<br />

1l<br />

Susp. 23 mg/ml,<br />

5 mg/ml,<br />

5 500 AU/ml<br />

15 ml<br />

Strength<br />

Susp. Parvo-5.280 ml, E. rhusiopathiae-10.000<br />

ml, Leptospira<br />

Bratislava-1.660 ml, L. Canicola-1.000<br />

ml, L.<br />

Grippo-1.000 ml, L.<br />

Hardjo-2.340 ml, L.<br />

Ictero-1.760 ml, L.<br />

Pomona-1.200 ml<br />

60 + 270 ml<br />

Susp. Mycoplasma hyopneomoniae<br />

antigen 2×10 9 /2 ml<br />

100 ml<br />

Marketing<br />

authorisation holder<br />

Ceva Sante Animale<br />

Janssen Animal<br />

Health BVBA<br />

Fort Dodge Animal<br />

Health<br />

Fort Dodge Animal<br />

Health<br />

Essence homeopatic Essence 0.5 + 1, 5 + 10 + 25 l Phylak Sachsen<br />

GmbH<br />

Cobaltum chloridum,<br />

Natrium chloridum<br />

Tabl. 0.04 g,<br />

0.96 g<br />

1+2+3+5kg<br />

561. Tabulettae kaiod Potassium iodide Tabl. 0.003 g in 0.1 g tabl.,<br />

0.006 g in 0.2 g tabl.<br />

0.25 + 0.5 + 0.8-1 +<br />

1.6-1.8 kg<br />

562. Tamirex Environmental Spray Propoxur,<br />

Triflumuron<br />

563. TELMIN +trichlorfon Mebendazolum,<br />

Metrifonatum<br />

564. Tenaver Niklozamid,<br />

Levamysol chloride<br />

565. TENAZYM® Tetracycline hydrochloride<br />

Neomycin sulphate<br />

Prednisolone acetate<br />

Trypsin<br />

Chymotrypsin<br />

Papain<br />

566. Testseren ‘Anti-Coli’<br />

(Polyspezifiche OK-Testseren<br />

‘Anti-Coli’, Monospezifische<br />

OK-bzw.O-Testseren ‘Anti-<br />

Coli’). Testiniai serumai ‘Anti-<br />

Coli’(Monospecifiniai OKbzw.O-Testserumai<br />

‘Anti-Coli’<br />

ir Polispecifiniai OK-<br />

Testserumai ‘Anti-Coli’)<br />

Monospecific and polyspecific<br />

sera for diagnosis of E.coli<br />

Aerosol 0,25 g,<br />

0,6 g<br />

400 ml<br />

Paste 100 mg,<br />

459 mg<br />

Tabl. 0,72 g,<br />

0,02242 g<br />

10 tabl.<br />

Susp. 30 mg<br />

22.5 mg<br />

2mg<br />

0.4 mg<br />

0.4 mg<br />

1 mg/ml<br />

10 ml<br />

JSC Kyiev Vitamin<br />

Enterprise<br />

JSC Kyiev Vitamin<br />

Enterprise<br />

Bayer AG, Animal<br />

Health Division<br />

JANSSEN<br />

PHARMACEUTICA<br />

N.V.<br />

Polfa Grodzisk<br />

Veyx-Pharma GmbH<br />

Susp. Institut fur<br />

Immunpraparate und<br />

Nahrmedien GmbH<br />

Berlin ‘SIFIN’


EN<br />

432 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

567. TETANUSAN 24 % Calciumgluconate,<br />

Magnesium chloride,<br />

Disodium — 1 —<br />

glycerinphosphate,<br />

Manganese chloride,<br />

Cobalt gluconate,<br />

Boric acid<br />

568. TETANUSAN 50 % Calciumgluconate,<br />

Magnesium chloride,<br />

Disodium-1 —<br />

glycerinphosphate,<br />

Iron (III) — glycerinphosphate,<br />

Manganese chloride,<br />

Cobalt (II) — gluconate<br />

Pharmaceutical<br />

form<br />

Susp. 24 g,<br />

8g,<br />

1g,<br />

0.02 g,<br />

0.02 g,<br />

5 g/100 ml<br />

Susp. 44 g,<br />

12.5 g,<br />

2g,<br />

0.375 g,<br />

0.02 g,<br />

0.02 g<br />

569. Tetra Tablets Oxytetracycline hydrochloride Tabl. 500 mg<br />

100 tabl.<br />

570. Tetra-Delta susp. Novobiocin,<br />

Neomycini sulfas<br />

571. Tetraoleandomycinum pulvis<br />

hydrosolub1lis<br />

572. TETRASEPTIN 100,<br />

TETRASEPTIN 200<br />

Tetracycline hydrochloride,<br />

Oleandomycinum<br />

phosphoricum<br />

Susp. 100 mg/10 ml,<br />

150 mg/10 ml<br />

10 ml<br />

Powder 3,42-3,78 g,<br />

1,71-1,8 g<br />

225 g<br />

Strength<br />

Tetracycline Sol. 100-200 mg/ml<br />

10 ml<br />

573. TETRASOL 20 % L.A. Oxytetracycline (as dihydrate) Sol. 200.0 mg/ml<br />

100 ml<br />

574. Tetravet L.A. Oxytetracycline,<br />

Dimethylacetamideale,<br />

Light magnesium oxide<br />

Sol. 20000000 IU,<br />

50 mg,<br />

1.85 g<br />

100 + 250 ml<br />

575. TIAMIX — premix Thiamulin Powder 80 g<br />

10 + 25 kg<br />

576. Tiamowet 200 injectio Tiamulin Sol. 200 mg/ml<br />

50 + 100 + 250 ml<br />

577. Tiamowet 45 % Tiamulin hydrofumorate Powder 45 g/100 g<br />

100 + 500 g<br />

578. TIGUVON 10, 20, 20 G, 20<br />

XL<br />

579. Tylan 50 inj., Tylan 200 inj.,<br />

Tylan tablets<br />

Fenthion (Thiophosphoric acid<br />

O,O'-dimethyl-O''-(3-methyl-4methylthio-phenyl)<br />

ester)<br />

Tylosin Sol.<br />

Tabl.<br />

Sol. 100 mg or 200 mg/ml<br />

0.3+0.4+1+2 ml pipets<br />

580. Tylan G — 100 Premix Tylosin concentrate Powder 100 g/kg<br />

25 kg<br />

581. Tylan Soluble Tylosin tartrate Powder 100 %<br />

1kg<br />

582. Tylasul G — 100 Premix Tylosin concentrate,<br />

Sulphamethazine<br />

50 mg or 200 mg<br />

50 + 100 ml<br />

200 mg<br />

50 tabl.<br />

Powder 100 g/kg,<br />

100 g/kg<br />

5+25kg<br />

583. TYLBIAN 20 % INJECTIO Tylosin tartrate Sol. 220.0 mg/ml<br />

50+100+250 ml<br />

Marketing<br />

authorisation holder<br />

ATAROST GmbH &<br />

Co.<br />

ATAROST GmbH &<br />

Co.<br />

Bimeda Chemicals<br />

export<br />

Pharmacia<br />

Vet Prom Ltd.<br />

CHASSOT AG.<br />

Richter Pharma AG<br />

Ceva Sante Animale<br />

Chemifarma S.p.A.<br />

Biowet<br />

Pharmaceutical<br />

Company Inc.<br />

Biowet<br />

Pharmaceutical<br />

Company Inc.<br />

Bayer AG, Animal<br />

Health Division<br />

Elanco Animal<br />

Health, Eli Lilly<br />

Gmbh<br />

Elanco Animal<br />

Health, Eli Lilly<br />

Gmbh<br />

Elanco Animal<br />

Health, Eli Lilly<br />

Gmbh<br />

Elanco Animal<br />

Health, Eli Lilly<br />

Gmbh<br />

Zakłady<br />

Farmaceutyczne<br />

‘Biowet’ Sp. z o.o.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 433<br />

No. Commercial name General name<br />

Pharmaceutical<br />

form<br />

Strength<br />

Marketing<br />

authorisation holder<br />

584. Tylo — Suscit 100 Tylosintartrat Powder 1000 g Bela-Pharm GmbH &<br />

Co. KG<br />

585. Tyloject 20% pro inj. Tylosin tartrate Sol. 220 mg/ml<br />

50 + 100 ml<br />

586. TYLOSIN 200 Tylosin tartrate Sol. 200 mg/ml<br />

100 ml<br />

587. Tylosin 200 Tylosintartrat Sol. 200 mg/ml<br />

100 ml<br />

588. Tylosin 20H, sol. inj. Tylosin tartrat Sol. 220 mg/ml<br />

100 ml<br />

589. Tylovet — T Tylosin tartrate Powder >800 IU/mg<br />

25 kg<br />

590. Tylovet 25-50 % Tylosin phosphate Powder 25-50 g<br />

20 kg<br />

591. Tylovit 90 N, pulv. Tylosin tartrat,<br />

Neomycin sulfat,<br />

Vitmanines<br />

Powder 55 mg/1000 g,<br />

10g/1000 g,<br />

100 g + 1 kg<br />

592. Tympany Dimethicone Sol. 100 mg<br />

100 + 250 + 500 ml<br />

593. TIMPANOLIS Silica organic<br />

Lactic acid<br />

Tinc. veratri<br />

594. TYMPASOL Simethicone<br />

Aluminium magnesium silicate<br />

595. TINCTURA VERATRI Rhizoma cum radicibus Veratri<br />

Spiritus aethylicus 70 %<br />

596. TNV YOUNG ANIMAL ORAL-<br />

SUSPENSION VEYX®<br />

597. TRICHOBEN AV inj. sic. ad us.<br />

vet.<br />

Tetracycline hydrochloride<br />

Neomycin sulphate<br />

Prednisolone acetate<br />

Retinol palmitate (Vit.A)<br />

Cholecalciferol (Vit.D 3)<br />

α-Tocoferyl acetate (Vit.E)<br />

Thiamine Hydrochloride<br />

(Vit.B 1)<br />

Riboflavine Sodium<br />

diphosphate (Vit.B 2)<br />

Pyridoxine hydrochloride<br />

Cyanocobalamine (Vit.B 12)<br />

Calcium panthotenate<br />

Nicotinamide<br />

Vaccine against Trichophyton<br />

verrucosum<br />

598. TRICHOBEN inj. sic. ad us. vet. Vaccine against Trichophyton<br />

verrucosum<br />

599. Trimerazin pulv. Sulfamerazinum,<br />

Trimethoprim<br />

600. Trimerazin tabl. Sulfamerazinum,<br />

Trimethoprim<br />

Susp. 100 g<br />

30 g<br />

35 g<br />

200+250 ml<br />

Sol. 1.5 g<br />

0.5 g/50 g<br />

50 ml<br />

Tinct. 100.0 g<br />

1000.0 ml<br />

40+100 ml<br />

Susp. 30.00 mg<br />

22.50 mg<br />

2.00 mg;<br />

10 000 I.U<br />

2 000 I.U<br />

25.00 mg<br />

10.00 mg<br />

12.50 mg<br />

5.00 mg<br />

100.00 mg;<br />

5.00 mg<br />

10.00 mg/ml<br />

10 ml<br />

Lyoph. vac. Trichophyton verrucosum 2.5<br />

× 10 6 /ml<br />

20 + 50 + 100 ml<br />

Lyoph. vac. Trichophyton verrucosum 2.5<br />

× 10 6 /ml<br />

20 + 50 + 100 ml<br />

Powder 0,1 g,<br />

0,02 g/g<br />

100 + 300 + 1,000 g<br />

Tabl. 0,4 g,<br />

0,08 g/tabl.<br />

100 tabl.<br />

Bremer Pharma<br />

GmbH<br />

Veyx-Pharma GmbH<br />

Atarost GmbH<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Biovet Joint Stock<br />

Company<br />

Biovet Joint Stock<br />

Company<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Alfasan International<br />

B. V.<br />

Lithuanian and<br />

French JSC<br />

‘Ukmerge˙s<br />

biofabrikas’<br />

C. Richter GesmbH<br />

&CoKG<br />

JSC ‘Vilniaus<br />

farmacijos fabrikas’<br />

Veyx-Pharma GmbH<br />

Bioveta Plc.<br />

Bioveta Plc.<br />

Polfa<br />

Polfa


EN<br />

434 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

601. Trimethosulf susp. pro inj. Sulfamerazinum,<br />

Sulfadiazinum,<br />

Sulfathiazolum,<br />

Trimethoprim<br />

602. TRIMETOSUL® 48 %<br />

suspension for injections<br />

603. Trimetox Veyx pro inj. Trimethoprimum,<br />

Sulfamethoxazolum<br />

604. Trypan Diminazen-di-aceturat,<br />

Antipyrin,<br />

Procainhydrochlorid,<br />

Mentanox 20 DF Spezial<br />

605. TRISULFON SUSPENSION Sulfamonomethoxine sodium<br />

Trimethoprim micr<br />

606. Trisul-kel 15 % Trimethoprim,<br />

Sulfadimidine<br />

607. Trivepar olige susp. Colistin sulfat,<br />

Streptomycin sulfat,<br />

Erythromycin thiocyanat<br />

608. Trivirovax Canine Distemper, Canine<br />

Adenovirus Vaccine and<br />

Canine Parvovirus Vaccine,<br />

Inactivated<br />

609. Trivitamin, Trys vitaminai A,<br />

D3, E<br />

610. Trivitum (Solutio oleosa<br />

vitaminorum ADE<br />

injectionibus)<br />

611. Tucoprim 150 (Uniprim<br />

150)Premix<br />

612. TUCOPRIM SOLUBLE<br />

POWDER<br />

Pharmaceutical<br />

form<br />

Susp. 100 mg,<br />

60 mg,<br />

40 mg,<br />

40 mg/ml<br />

50 + 100 ml<br />

Trimethoprim Sol. 80.0 mg/ml<br />

50+100 ml<br />

Vitamin A,<br />

Vitamin D3,<br />

Vitamin E<br />

Vitamin A<br />

Vit. D<br />

Vit. E<br />

Sulfadiazine100,<br />

Trimethoprim<br />

Trimethoprim<br />

Sulfadiazine sodium<br />

613. UBROCELAN®, Procaine benzylpenicillin<br />

monohydrate<br />

Neomycin sulphate<br />

Sol. 40 mg,<br />

200 mg/ml<br />

250 ml<br />

Strength<br />

Susp. 7 g/100 ml,<br />

8,33 g/100 ml,<br />

0,4 g/100 ml,<br />

10 g/100 ml<br />

15 + 30 + 50 + 100 ml<br />

Sol. 40.0 g<br />

8.0 g/100 ml<br />

100+1000 ml<br />

Sol. 200 mg,<br />

40 mg<br />

50 + 100 + 250 ml<br />

Susp. 11,1 mg,<br />

52,64 mg,<br />

62,5 mg/ml<br />

100 ml<br />

Freeze dried<br />

vac.<br />

Sol. 30000 IU,<br />

40000 IU,<br />

20 mg/ml<br />

Sol. 30000 IU.<br />

40000 IU.<br />

20 mg/ml<br />

100 ml<br />

Powder 125 g/kg,<br />

25-50 g/kg<br />

2+12kg<br />

Powder 125 g<br />

625 g/kg<br />

150g+2 kg<br />

Susp. 1,5 %;<br />

0,5 g<br />

13.7 g<br />

614. ULTRAPEN LA Procaine benzylpenicillin Sol. 300 mg/ml<br />

50+100 ml<br />

615. Ursocyclin-Eutersalbe ung. Oxytetracyclini<br />

hydrochloridum<br />

616. Ursoferran 100 pro inj. Ferri hydroxydum,<br />

Dextran<br />

617. Ursolyt G oral Sodium chlorid,<br />

Sodium hydrogencarbonate<br />

Ointm. 0,425 g/9 g<br />

9g<br />

Distemper disease virus, >10 3<br />

CCID 50, Canine Adenovirus<br />

>10 2.5 CCID 50, Canine<br />

parvovirus >10 3 CCID 50<br />

10 doses<br />

Sol. 191 mg/ml,<br />

100 mg/ml<br />

100 + 500 ml<br />

Powder 14,28 g,<br />

16 g<br />

700 g<br />

Marketing<br />

authorisation holder<br />

Bremer Pharma<br />

GmbH<br />

Pliva Pharmaceutical<br />

Industry Inc.<br />

Veyx-Pharma GmbH<br />

Atarost<br />

KRKA, d.d.<br />

Kela Laboratoria<br />

Veyx-Pharma GmbH<br />

Merial<br />

OAO Mosagrogen<br />

JSC Kyiev Vitamin<br />

Enterprise<br />

Cheminex<br />

Laboratories Ltd.<br />

Pharmacia<br />

Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

Norbrook<br />

Laboratories Limited<br />

Serum-Werk<br />

Bernburg AG<br />

Serum-Werk<br />

Bernburg AG<br />

Serum-Werk<br />

Bernburg


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 435<br />

No. Commercial name General name<br />

618. Ursovit AD 3E olig pro inj. Retinolpalmitat,<br />

Cholecalciferol<br />

α-Tocopherolacetat<br />

619. UT ‘FORTE’ Chlortetracycline<br />

hydrochloride<br />

A vitamine acetate<br />

620. UTEROTONIC Propranolol chlorhydrat,<br />

Citric acid<br />

Pharmaceutical<br />

form<br />

Susp. 100 000 UI,<br />

5 000 UI,<br />

20 mg<br />

100 ml<br />

Bolus 0.515 g<br />

0.220 g<br />

boluses<br />

Sol. 5 mg,<br />

0.12 mg/ml<br />

10 ml<br />

621. VAGOTHYL 36 % Policresulenum Sol. 36,0 g/100 ml<br />

50 g<br />

622. Vakcina COLISUIN — CL Porcine E. Coli and<br />

Clostridium Vaccine,<br />

Inactivated<br />

623. VALPIRINE powder Acide acétylsalicylique (sous<br />

forme de calcium urée)<br />

624. Vanguard 5/L Canine distemper virus<br />

Canine Adenovirus type 2<br />

Canine parainfluenza virus<br />

Canine Parvovirus<br />

Leptospira<br />

icterohaemorrhagiae<br />

Leptospira canicola<br />

Emmulse 1 dose/2 ml<br />

2ml<br />

Strength<br />

Powder 20 g/100 g<br />

100 g+1+2.5 kg<br />

Susp. 10 3.5 TCID 50<br />

10 3.4 TCID 50<br />

10 5.5 TCID 50<br />

10 5.1 TCID 50<br />

25 doses<br />

625. VEYX®YL LA 200 Amoxycillin trihydrate Susp. 229.6 mg<br />

100 ml<br />

626. Vepha Gent pro inj. Gentamycini sulfas Sol. 85 mg/ml<br />

100 ml<br />

627. Vermitan 10 % suspension Albendazole Susp. 10 g<br />

100ml+1+5l<br />

628. VETEUSAN Crotamiton<br />

Emulgade F special<br />

Carbopol 980 NF<br />

Triethanolamine<br />

Emuls. 100.0 mg<br />

20.0 mg<br />

1.30 mg<br />

1.30 mg/ml<br />

100 ml<br />

Marketing<br />

authorisation holder<br />

Serum-Werk<br />

Bernburg<br />

C. Richter GesmbH<br />

&CoKG<br />

WARSAW<br />

PHARMACEUTICAL<br />

WORKS POLFA<br />

Pabianickie Zakłady<br />

Farmaceutyczne<br />

Polfa<br />

LABORATORIOS<br />

HIPRA S.A.<br />

Laboratoires<br />

SOGEVAL<br />

Pfizer Animal Health<br />

Veyx-Pharma GmbH<br />

Veyx-Pharma GmbH<br />

Ceva Sante Animale<br />

Richter Pharma AG<br />

629. VETMEDIN 2,5 mg Pimobendan Capsul. 2,5 mg Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

630. VETMEDIN 5 mg Pimobendan Capsul. 5,00 mg Boehringer<br />

Ingelheim Danmark<br />

A/S<br />

631. VETOFLOK 10 % Oral solution Enrofloxacin Sol. 100. 0 g/l<br />

100 ml + 1 l<br />

632. VETOFLOK 5% Solution for<br />

infections<br />

633. VETRAMYCIN Penicillin G procaine<br />

monohydrate coated with<br />

lecithin,<br />

Dihydrostreptomycin sulfate,<br />

Prednisolone acetate,<br />

Procaine hydrochloride<br />

634. VH +H-120 live vaccine Newcastle Disease and Avian<br />

Infectious Bronchitis Vaccine,<br />

Living<br />

Enrofloxacin Sol. 50.00 mg/ml<br />

100 ml<br />

Susp. 100 000 IE,<br />

100 000 IE,<br />

4.0 mg,<br />

20.0 mg/ml<br />

100 ml<br />

Lyoph. vac. ND virus, IBD virus 95 %<br />

250-500 ml<br />

PLIVA D. D. B.V.<br />

PLIVA d. d. B.V.<br />

WERFFT — CHEMIE<br />

B.V.<br />

Abic Ltd.


EN<br />

436 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No. Commercial name General name<br />

635. VIBEPLEX Vitamin B1,<br />

Vitamin B2,<br />

Vitamin B6,<br />

Vitaminas B12,<br />

Nicotinamide,<br />

Pantothene<br />

636. Virbagen canis SHA2/LT Canine distemper virus<br />

(Lederle strain)<br />

Canine adenovirus type 2<br />

(Manhattan strain)<br />

Leptospira canicola<br />

Leptospira<br />

icterohaemorrhagiae<br />

Inactivated rabies suspension<br />

(VP12 strain)<br />

637. Vit.E+SE pro inj. Vitamin E acetate,<br />

Sodium selenite<br />

638. Vitamin AD 3 E sol pro inj. Retinoli palmitatum,<br />

Cholecalciferolum,<br />

Tocopheroli acetas<br />

639. VITAMIN AD 3E Vitamin E (dl-α-tocopherol<br />

acetate)<br />

Vitamin D (cholecalciferol)<br />

Vitamin A (retinol palmitate)<br />

640. Vitamin AD3E Conzentrat Vit. A palmitat,<br />

Chole- calciferol,<br />

Alpha tocopheryl acetate<br />

641. Vitamin AD 3E forte pro inj. Vitamin A,<br />

Vitamin D 3,<br />

Vitamin E<br />

642. Vitamin AD 3E pro inj. Vitaminum A,<br />

Vitaminum D 3,<br />

Vitaminum E<br />

643. Vitamin B — Komplex mit<br />

Leberext pro inj.<br />

644. Vitamin B Complex Vitamin B1,<br />

Vitamin B12,<br />

Vitamin B2,<br />

Nicotinamide,<br />

Vitamin B6,<br />

Vitamin C<br />

Pharmaceutical<br />

form<br />

Sol. 10.00 mg,<br />

5.72 mg,<br />

4.00 mg,<br />

10.00 mg,<br />

50.00 mg,<br />

4.26 mg/m<br />

100 ml<br />

Strength<br />

Susp. 103 TCID50<br />

300 TCID50<br />

800·106 bact./ml<br />

800·106 bact./ml<br />

1IU<br />

10 ir 50 doziu˛<br />

Sol. 50 mg/ml,<br />

0,5 mg/ml<br />

100 ml<br />

Sol. 50 000 UI/ml,<br />

25 000 UI/ml,<br />

20 mg/kg<br />

100 + 1,000 ml<br />

Sol. 20,0 mg<br />

40 000 IU<br />

80 000 IU<br />

50+100 ml<br />

Sol. 29.42 mg,<br />

6.25 mg,<br />

20 mg<br />

100 ml<br />

Sol. 300 000 AU,<br />

100 000 AU,<br />

50 mg/ml<br />

Sol. 300 000 AU,<br />

100 000 AU,<br />

50 mg/ml<br />

100 ml<br />

Marketing<br />

authorisation holder<br />

ImmCont GmbH<br />

Virbac S.A.<br />

Farvet Laboratories<br />

B.V.<br />

KRKA<br />

Farvet Laboratories<br />

B.V.<br />

Atarost GmbH & Co.<br />

Bremer Pharma<br />

GmbH<br />

Bela-Pharm GmbH &<br />

Co.<br />

Vit. B complex Sol. 100 + 250 ml Bela-Pharm GmbH<br />

Co.<br />

Sol. 35 mg,<br />

2 mkg,<br />

0.5 mg,<br />

23 mg,<br />

7 mg,<br />

70 mg<br />

100 ml<br />

Alfasan International<br />

B. V.<br />

645. Vitamin B komplex pro inj. Vit. B complex Sol. 100 ml Veyx-Pharma GmbH<br />

646. Vitamin E +Selenium Vitamin E acetate,<br />

Sodium selenite<br />

647. Vitamin E+Selen pro inj. Vitaminum E,<br />

Natrii selenis<br />

Sol. 100 mg,<br />

3mg<br />

100 ml<br />

Sol. 100 mg,<br />

3 mg/ml<br />

100 ml<br />

Bremer Pharma<br />

Bela-Pharm GmbH<br />

Co.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 437<br />

No. Commercial name General name<br />

648. VITAMINOSOL Vitamin A<br />

Vitamin D 3<br />

Vitamin E<br />

Vitamin K 3<br />

Vitamin B 1<br />

Vitamin B 2<br />

Vitamin B 6<br />

Vitamin B 12<br />

Vitamin C<br />

Vitamin H<br />

Nicotinic acid<br />

Pantothenic acid<br />

Folic acid<br />

Pantothenic acid<br />

Folic acid<br />

Inositol<br />

Asparic acid<br />

Glutamic acid<br />

Alanine<br />

Arginine<br />

Cystine<br />

Choline<br />

Phenylalanine<br />

Glycine<br />

Valine<br />

Hystidine<br />

Isoleucine<br />

Leucine<br />

Lysine<br />

Methionine<br />

Proline<br />

Serine<br />

Threonine<br />

Tyrosine<br />

Tryptophan<br />

649. VITASOL AD 3EC Vitamin A,<br />

Vitamin D 3,<br />

Vitamin E,<br />

Vitamin C<br />

650. VITESEL Vitamin E<br />

Potasium selenate equivalent to<br />

selenium<br />

Pharmaceutical<br />

form<br />

Sol. 20 000 000 IU<br />

4 000 000 U.I<br />

10 g<br />

5g<br />

5g<br />

6g<br />

3g;<br />

10 g<br />

50 g<br />

1g<br />

2g<br />

10 g<br />

1g<br />

10 g<br />

1g<br />

2g<br />

6,4 g<br />

10 g<br />

4,4 g<br />

6,8 g<br />

6,4 g<br />

4,5 g<br />

4,4 g<br />

7,2 g<br />

8g<br />

0,4 g<br />

4,8 g<br />

7,6 g<br />

6,6 g<br />

3,4 g<br />

10,4 g<br />

12,4 g<br />

4,8 g<br />

2,4 g<br />

2,2 g/l<br />

1+5 l<br />

Sol. 50 000 IU,<br />

25 000 IU;<br />

30 mg;<br />

100 mg/ml<br />

100 ml<br />

Emuls. 68 mg<br />

1.5 mg/ml<br />

50 ml<br />

Strength<br />

Marketing<br />

authorisation holder<br />

Investigaciones<br />

Quimicas y<br />

Farmaceuticas, S.A.<br />

C. Richter GesmbH<br />

&CoKG<br />

NORBROOK<br />

Laboratories Limited<br />

651. VULKETAN GEL Ketanserin tartrate Gel 3.45 mg JANSSEN<br />

PHARMACEUTICA<br />

N.V.<br />

652. WORMASOLE Fenbendazole Gran. 220 mg/g<br />

1+2+4 g<br />

Norbrook<br />

Laboratories Limited<br />

653. XYLAPAN Xylazine Sol. 20.0 mg/ml CHASSOT AG<br />

654. Xylazin 2 Xylasin hydroxichlorid Sol. 2,332 g<br />

25 + 100 ml<br />

655. Xylazine 2 % Xylazine Sol. 20 mg/ml<br />

30 ml<br />

656. Zoomycolum aerosolum 155 g Nitroxolinum,<br />

Thiabendazole,<br />

Dimethyl sulphoxide<br />

Aerosol 0,525 g,<br />

1,05 g,<br />

5,25 g<br />

155 g<br />

Bela-Pharm GmbH &<br />

Co. KG<br />

Alfasan International<br />

B.V.<br />

Vet Prom Ltd.


EN<br />

438 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Appendix B<br />

referred to in Chapter 5, Section B, Subsection I of Annex IX (*)<br />

List of establishments, including shortcomings and deadlines for the correction of these shortcomings<br />

MEAT ESTABLISHMENTS<br />

No Vet. No Name of establishment Shortcomings<br />

HC Fresh meat establishment (slaughtering)<br />

1 21-11 UAB ‘Klaipe˙dos me˙sa’ Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1<br />

Annex I, Chapter I, point 2<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5, 9, 11, and 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(f), (g), (h), (k), and (l)<br />

Annex I, Chapter III, point 15(b)<br />

Annex I, Chapter IV, point 16(a)<br />

Combined HC establishments (slaughtering, fresh meat, meat products, meat preparations)<br />

2 77-23 Z.Gerulio II˛ Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1<br />

Annex I, Chapter I, point 2<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 9, 11 and 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(f), (g), (h), (k), and (l)<br />

Annex I, Chapter III, point 15(b),<br />

Council Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 3, 4, 6, 7, 8, 9,<br />

11, 12, and 15<br />

Annex B, Chapter I, point 1(a), (d), (e) and<br />

(f)<br />

Annex B, Chapter I, point 2(d), (e), (h), and<br />

(i)<br />

3 77-02 UAB ‘Stragute˙s me˙sa’ Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e),<br />

(f), and (g)<br />

Annex I, Chapter I, point 2<br />

Annex I, Chapter I, points 11 and 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(g), (h), (k), and (l)<br />

Annex I, Chapter III, point 15(b)<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 3, 4, 6, 8, 9, 11<br />

and 15<br />

Annex B, Chapter I, point 1(a), (d), (e) and<br />

(f)<br />

Annex B, Chapter I, point 2(a), (b) and (j)<br />

(*) For the text of Annex IX see OJ L 236, 23.9.2003, p. 836.<br />

Date of full<br />

compliance<br />

1.11.2006<br />

1.11.2006<br />

1.11.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 439<br />

No Vet. No Name of establishment Shortcomings<br />

4 88-01 AB ‘Grabupe˙liai’ Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1<br />

Annex I, Chapter I, point 2<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5, 9, 11 and 12<br />

Annex I, Chapter II, point 14(b), (c), (d), (e),<br />

(h), (k) and (l)<br />

Annex I, Chapter III, point 15(b) and (d)<br />

Annex I, Chapter IV, point 16(a)<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), and (g)<br />

Annex A, Chapter I, points 4, 6, 7, 8, 9, 11<br />

and 15<br />

Annex B, Chapter I, point 1(a) and (f)<br />

Annex B, Chapter I, point 2(c), (d), (i) and (j)<br />

HC Meat products establishments<br />

5 21.14 UAB ‘Klaipe˙dos me˙sine˙’ Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter III, point 15(b)<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 4, 6, 7, 8, 11,<br />

12, 13, 14, and 15<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (h), and (i)<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter I, point 1(a) and (b)<br />

Annex I, Chapter III, point 1<br />

6 41-20 UAB ‘Rukesa ir ko’ Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f)<br />

and (g)<br />

Annex I, Chapter III, point 15(b)<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 3, 7, 8, 11, 12,<br />

14 and 15<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(c), (d), (e) and<br />

(h)<br />

Date of full<br />

compliance<br />

1.11.2006<br />

1.11.2006<br />

1.5.2006


EN<br />

440 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of establishment Shortcomings<br />

7 72-01 BI˛ ‘Litmos’ Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter III, point 15(b)<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 3, 4, 6, 7, 8, 9,<br />

11, 12, 13, 14 and 15<br />

Annex B Chapter I, point 1<br />

Annex B Chapter I, point 2(a), (b), (c), (d),<br />

(e), (h), (i) and (j)<br />

Council Directive 94/65/EC:<br />

Annex I, Chapter I, point 1(a)<br />

8 11 AB ‘Vilniaus me˙sos kombinatas’ Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c) and<br />

(d)<br />

Annex A, Chapter I, points 4, 12 and 15<br />

Annex B, Chapter I, point 1(d), (e) and (f)<br />

Annex B, Chapter I, point 2(b) and (d)<br />

9 01-23 UAB ‘Esla’ Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (c), (e) and<br />

(g)<br />

Annex A, Chapter I, points 7, 8, 11, 13 and<br />

14<br />

Annex B, Chapter I, point 1(d) and (f)<br />

10 01-29 UAB ‘Naujasodzˇio me˙sa’ Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 11 and 15<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(c)<br />

LC Meat products establishments<br />

11 77-32 V.Pietariene˙s II˛ Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c) and (e)<br />

Annex I, Chapter III, point 15(b)<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(b), (c), (d), (e)<br />

and (g)<br />

Annex A, Chapter I, points 3, 4, 6, 11, 12,<br />

13 and 14<br />

Annex B, Chapter I, point 1(a), (d) and (e)<br />

Annex B, Chapter I, point 2(a), and (j)<br />

Date of full<br />

compliance<br />

1.11.2006<br />

1.12.2004<br />

1.12.2004<br />

1.12.2005<br />

1.1.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 441<br />

No Vet. No Name of establishment Shortcomings<br />

12 27-13 UAB ‘Guoste˙’ Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c), (e) and (f)<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(d) and (e)<br />

Annex A, Chapter I, points 3, 4, 8, 9, 11,<br />

13, and 15<br />

Annex B, Chapter I, point 2(a), (d) and (j),<br />

HC Poultry meat, meat products and preparations establishments<br />

13 79-01 AB ‘Vievio paukštynas’ Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(b), (c), (e) and<br />

(g),<br />

Council Directive 71/118/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f)<br />

and (g)<br />

Annex I, Chapter I, point 2<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 9 and 10<br />

Annex I, Chapter II, point 14(c), (e) and (g),<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, point 14<br />

Annex B, Chapter I, point 1(b), (c), (d) and<br />

(e)<br />

Annex B, Chapter I, point 2(c), (e) and (h),<br />

14 49-02 AB ‘Girele˙s paukštynas’ Council Directive 71/118/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f)<br />

and (g)<br />

Annex I, Chapter I, point 2<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5, 8, 9, 10, 11,<br />

12 and 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (e)<br />

and (g)<br />

Annex I, Chapter III, point 15<br />

Annex I, Chapter IV, point 16(a)<br />

Date of full<br />

compliance<br />

1.11.2006<br />

1.8.2006<br />

1.11.2006


EN<br />

442 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

FISHERY PRODUCTS ESTABLISHMENTS<br />

No Vet. No Name of establishment Shortcomings<br />

1 21-05 UAB ‘Portlita’ Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (h)<br />

Annex, Chapter III.I, points 5, 6, 9, 10 and<br />

11<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter IV.II, point 3<br />

Annex, Chapter IV.IV, points 2 and 5<br />

Annex, Chapter IV.IV, point 6(a)<br />

Annex, Chapter IV.V, point 1<br />

2 21-17 UAB ‘Klaipe˙dos me˙sine˙’ Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (b), (c), (d),<br />

(e), (f) and (h)<br />

Annex, Chapter III.I, points 3, 5, 6, 8, 9, 10<br />

and 11<br />

Annex, Chapter IV.II, point 3 Annex,<br />

Chapter IV.IV, point 2<br />

3 66-25 UAB ‘Lipresa’ Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (d), (e) and<br />

(h)<br />

Annex, Chapter III.I, points 3, 6, 9, 10 and<br />

11 Annex,<br />

hapter IV.IV, point 6(a)<br />

4 66-33 Zˇelnio i˛m. ‘Grundalas’ Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1Annex,<br />

Chapter III.I, point 2(a), (b), (c), (d), (e) and<br />

(h)<br />

Annex, Chapter III.I, points 5, 9, 10 and 11<br />

Annex,<br />

Chapter IV.IV, point 6(a) Annex,<br />

Chapter VIII, point 1<br />

5 55-27 UAB ‘Myxum’ Council Directive 91/493/EEC:<br />

Annex, Chapter III.I, point 1<br />

Annex, Chapter III.I, point 2(a), (c), (d), (e)<br />

and (h)<br />

Annex, Chapter III.I, points 5, 9 and 10<br />

Annex,<br />

Chapter IV.V, point 1 Annex,<br />

Chapter VIII, point 1<br />

Date of full<br />

compliance<br />

1.11.2006<br />

1.11.2006<br />

1.11.2006<br />

1.11.2006<br />

1.11.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 443<br />

MILK PRODUCTS ESTABLISHMENTS<br />

No Vet. No Name of establishment Shortcomings<br />

1 54-01P UAB ‘Kelme˙s pienine˙’ Council Directive 92/46/EEC:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex B, Chapter I, points 3, 11 and 13<br />

Date of full<br />

compliance<br />

1.11.2006


EN<br />

444 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Appendix A<br />

referred to in Chapter 5, Section B, point 1 of Annex X (*)<br />

List of establishments, including shortcomings and deadlines for the correction of these shortcomings<br />

MEAT ESTABLISHMENTS<br />

No Vet. No Name of establishment Shortcomings<br />

1 29/30/2000 Szilágy Gábor<br />

Vágóhíd-Feldolgozó<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 4(c) and (d)<br />

Annex I, Chapter I, points 10 and 12<br />

2 658/2001 Komárom Rt. Pontis Húsüzeme Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (c), (e) and (g)<br />

Annex I, Chapter I, point 4(a), (b), (c) and (d)<br />

3 27/7/1994 Babati és Társa Hús-feldolgozó,<br />

Kereskedelmi Kft. Vágóhíd és<br />

Húsüzem<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(e) and (g)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 4(c)<br />

4 7/15/1999 Ász-Kolbász Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, point 9<br />

5 304/3/1997 Molnár és Molnár Ker. Bt. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a) and (f)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, points 5, 8, and 12<br />

6 36/1999 Pásztorhús Kft. Vágóhídja Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c) and (d)<br />

Annex I, Chapter I, points 9 and 11<br />

7 10/1998 NYUGAT Nyíregyházi<br />

Szövetkezet Húsüzem<br />

8 101-56/2000 Aranykezű Kft. Vágóhíd és<br />

Feldolgozó<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c) and (e)<br />

Annex I, Chapter I, point 2<br />

Annex I, Chapter I, point 4(b) and (c)<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 6, 7 and 12<br />

9 13/1993 Ga-Zsó Hús Vágóhídja Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c), (e) and (g)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c) and (d)<br />

Annex I, Chapter I, points 8, 11 and 12<br />

(*) For the text of Annex X see OJ L 236, 23.9.2003, p. 846.<br />

Date of full<br />

compliance<br />

31.12.2005<br />

31.12.2004<br />

31.12.2006<br />

31.12.2004<br />

31.12.2006<br />

31.12.2005<br />

31.12.2005<br />

31.12.2004<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 445<br />

No Vet. No Name of establishment Shortcomings<br />

10 27/35/1994 Felsál Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b), (c), (f) and<br />

(g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, points 5, 11 and 12<br />

11 60-56/1994 Gorzsai Húsüzem Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (c), (e) and (g)<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 6, 7, 8, 11 and 12<br />

12 34/2000 Varga és Tsa. 2000 Kft.<br />

Vágóhídja<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c) and (e)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c) and (d)<br />

Annex I, Chapter I, point 9<br />

13 400-8/1998 Mada-Hús Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(b) and (c)<br />

Annex I, Chapter I, point 9<br />

14 28/18/1998 Hejőhús Kft. Vágóhídja Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 4(d)<br />

Annex I, Chapter I, points 9, 10 and 12<br />

15 101-38/2000 Füstöltkolbász Kolbász-készítő<br />

és Szolgáltató Kft.<br />

16 113-59:<br />

1024-2/1999<br />

Fömo-Hús Húsipari és<br />

Kereskedelmi Kft.<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (c) and (e)<br />

Annex I, Chapter I, point 4(b) and (c)<br />

Annex I, Chapter I, points 6, 7, 8, 9 and 11<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 9, 11 and 13<br />

17 101-72/2001 Héjja Testvérek Kft. Vágóhíd Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c) and (e)<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 6, 7, 11 and 12<br />

18 28/114/1996 Szirák-Farm Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b) and (f)<br />

Annex I, Chapter I, point 4(b) and (d)<br />

Annex I, Chapter I, points 5, 8, 10, and 12<br />

19 692-2/103/<br />

167/ 1992<br />

Juhász-Hús Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(g)<br />

Annex I, Chapter I, point 10<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2005<br />

31.12.2005<br />

31.12.2005<br />

31.12.2005<br />

31.12.2005<br />

31.12.2006<br />

31.12.2005<br />

31.12.2006<br />

31.12.2006


EN<br />

446 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of establishment Shortcomings<br />

20 43/1996 Sarud-Hús Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c), (e) and (g),<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c) and (d)<br />

21 94-5/2001 Pikker 2000 Bt. Vágóhídja Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c) and (d)<br />

Annex I, Chapter I, point 12<br />

22 55-83/1995 Apci-Hús Kft. Vágóhídja Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(e) and (g)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c) and (d)<br />

23 16-88/1997 Közérdekű Bt. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(b) and (e)<br />

Annex I, Chapter I, points 9 and 13<br />

24 55/1997 Bodó és Társa Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5 and 9<br />

25 1103/1/2000 Mikóhús Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c), (e) and (f)<br />

Annex I, Chapter I, point 2<br />

Annex I, Chapter I, point 4(b) and (e)<br />

Annex I, Chapter I, point 12<br />

26 60-300/1994 Dorozsmahús Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (c) and (e)<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 11,<br />

12 and 13<br />

27 45/1995 Bereg-Hús Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c) and (d)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, point 5<br />

28 28/9/1998 Sárvári Mezőgazdasági Rt.<br />

Vágóhíd-Húsüzem<br />

29 110/1/1994 Táncsics Mg. Devecseri<br />

Húsüzem<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c) and (e)<br />

Annex I, Chapter I, point 4(a), (b) and (c)<br />

Annex I, Chapter I, points 5, 11 and 12<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(b)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(b) and (c)<br />

Annex I, Chapter I, points 5, 11 and 12<br />

Date of full<br />

compliance<br />

31.12.2005<br />

31.12.2005<br />

31.12.2005<br />

31.12.2006<br />

31.12.2005<br />

31.12.2006<br />

31.12.2005<br />

31.12.2005<br />

31.12.2006<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 447<br />

No Vet. No Name of establishment Shortcomings<br />

30 336/1/2001 Palini Hús Rt. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c)<br />

Annex I, Chapter I, point 4(b)<br />

31 48/2000 Horváth Kft. Vágóhídja Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(e) and (g)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c) and (d)<br />

Annex I, Chapter I, point 12<br />

32 25/1998 Hultai István Vágóhídja Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(b), (c) and (f)<br />

Annex I, Chapter I, point 4(b) and (c)<br />

Annex I, Chapter I, point 9<br />

33 28/11/1999 Fehérpecsenye Kft. Vágóhíd-<br />

Húsüzem<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5, 9 and 11<br />

34 433-2/2000 Bajnainé Tsa. Bt. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c) and (e)<br />

Annex I, Chapter I, point 4(a), (c) and (e)<br />

Annex I, Chapter I, points 9, 11 and 13<br />

35 26/1994 Poszavecz József Vágóhídja Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c)<br />

Annex I, Chapter I, point 4(b)<br />

36 432/2000 Nemeshegyi Lászlóné Vágó és<br />

Húsfeldolgozó Üzeme<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c)<br />

Annex I, Chapter I, point 4(b) and (c)<br />

37 45-17/1998 Árvai Húsipari Kft. Vágóhídja Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(e) and (g)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c), (d) and (e)<br />

Annex I, Chapter I, points 9, 11 and 12<br />

38 139/3/2000 Szegvári Vágóhíd és Húsüzem Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 12<br />

39 16/159/1998 Konkoly Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(e) and (g)<br />

Annex I, Chapter I, point 4(c) and (e)<br />

Annex I, Chapter I, point 12<br />

40 113-10/<br />

519-2/1999<br />

Provizio-3 Kft. Fehérvárcsurgói<br />

Vágóhíd<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 10<br />

41 316-6/1998 Mészáros Ferenc Vágóhídja Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c)<br />

Annex I, Chapter I, point 4(a), (b), (c) and (d)<br />

Annex I, Chapter I, points 8, 9 and 10<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2005<br />

31.12.2005<br />

31.12.2006<br />

31.12.2004<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006<br />

31.12.2004


EN<br />

448 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of establishment Shortcomings<br />

42 52-93/1997 Gulyás és Társa Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c) and (e)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 11<br />

and 12<br />

43 1100/1/2001 Adonyhús Kft. Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(e) and (g)<br />

Annex I, Chapter I, point 4(d)<br />

Annex I, Chapter I, points 7 and 12<br />

44 28/17/1997 Jánosháza Hús Kft Vágóhíd-<br />

Húsüzem<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(c) and (e)<br />

Annex I, Chapter I, point 4(b) and (c)<br />

Annex I, Chapter I, point 9<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2006<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 449<br />

ANIMAL WELFARE<br />

Appendix B<br />

referred to in Chapter 5, Section B, point 2 of Annex X (*)<br />

List of establishments, including their production (eggs/year)<br />

No. Name of the establishment County<br />

Production<br />

(eggs/year)<br />

1 Gyermely Rt. Komárom-Esztergom 70 000 000<br />

2 Érsekcsanád tojótelep Bács-Kiskun 30 000 000<br />

3 Rákóczi Mg.Kft. Sápi tojótelep Hajdú-Bihar 30 000 000<br />

4 Sató Kft. Komárom-Esztergom 27 000 000<br />

5 Új Élet Szövetkezet Komárom-Esztergom 16 000 000<br />

6 Rábamenti Gazdaszövetkezet Vas 14 000 000<br />

7 Baromfi hús és tojásforgalmazó Kft. Komárom-Esztergom 11 000 000<br />

8 Nyugat Nyíregyházi Szövetkezet Szabolcs-Szatmár-Bereg 4 700 000<br />

9 Rákóczi TKSZ Heves 2 600 000<br />

10 Dr. Kalhammer Mátyás Békés 850 000<br />

11 Balázs Pintér András Heves 1 000 000<br />

12 Kaló László Heves 700 000<br />

13 Sütő Malom Kft. Hajdú-Bihar 650 000<br />

14 Képes Szilárd Heves 630 000<br />

15 Herkó Györgyné Békés 550 000<br />

16 Féderer Lőrinczné I. Bács-Kiskun 540 000<br />

17 Zatykó Mihály Bács-Kiskun 400 000<br />

18 Féderer Lőrinczné II. Bács-Kiskun 360 000<br />

19 Lovák Istvánné Bács-Kiskun 300 000<br />

20 Németh Antal Vas 96 000<br />

21 Szabados Zoltán Vas 28 000<br />

(*) For the text of Annex X see OJ L 236, 23.9.2003, p. 846.


EN<br />

450 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Appendix A<br />

referred to in Chapter 1, point 2 of Annex XI (*)<br />

Lists as provided by Malta in one language of pharmaceutical products for which a marketing authorisation issued under<br />

Maltese law prior to the date of accession shall remain valid until it is renewed in compliance with the acquis or until<br />

31 December 2006, whichever is the earlier.<br />

Mention on this list does not prejudge whether or not the pharmaceutical product in question has a marketing<br />

authorisation in compliance with the acquis.<br />

LIST OF PHARMACEUTICALS TO BE INCLUDED UNDER THE ARRANGEMENT NEGOTIATED UNDER<br />

CHAPTER 1<br />

Trade Name Dosage Form Dose MA Holder Country<br />

0.45% SODIUM CHLORIDE IN 5%<br />

GLUCOSE<br />

0.45% SODIUM CHLORIDE<br />

INJECTION USP<br />

0.45% SODIUM CHLORIDE<br />

INJECTION, USP<br />

0.9% SOD. CHLORIDE AND 5%<br />

GLUCOSE<br />

0.9% SODIUM CHLORIDE AND 5%<br />

GLUCOSE IV INF<br />

0.9% SODIUM CHLORIDE<br />

INJECTION<br />

0.9% SODIUM CHLORIDE<br />

INJECTION USP<br />

0.9% SODIUM CHLORIDE<br />

INJECTION USP<br />

0.9% SODIUM CHLORIDE<br />

IRRIGATION<br />

0.9% SODIUM CHLORIDE<br />

IRRIGATION USP<br />

0.9% W/V SODIUM CHLORIDE<br />

INJECTION BP<br />

0.9% W/V SODIUM CHLORIDE<br />

IRRIGATION SOL.<br />

0.9% W/V SODIUM CHLORIDE IV<br />

INFUSION BP<br />

INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR IV<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

GERMANY<br />

0.45% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

4.5MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

UNITED KINGDOM<br />

GERMANY<br />

SOLUTION FOR INJ 9MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

IRRIGATION<br />

SOLUTION FOR<br />

IRRIGATION<br />

SOLUTION FOR<br />

INJECTION<br />

0.9% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

0.9% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

9MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

0.9% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

0.9% W/V B.BRAUN MELSUNGEN<br />

AG<br />

IRRIGATION SOLUTION 0.9% W/V B.BRAUN MELSUNGEN<br />

AG<br />

INFUSION SOLUTION 0.9% W/V B.BRAUN MELSUNGEN<br />

AG<br />

1% W/V LIDOCAINE INJECTION INJECTION SOLUTION 1% W/V B.BRAUN MELSUNGEN<br />

AG<br />

1.5% GLYCINE IRRIGATION<br />

SOLUTION USP<br />

1.5% GLYCINE IRRIGATION USP SOLUTION FOR<br />

IRRIGATION<br />

1.5% W/V GLYCINE IRRIGATION<br />

SOL. BP<br />

1/2 STRENGTH CMPD. SODIUM<br />

LACTATE + GLUC<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

IRRIGATION SOLUTION 15MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

15MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

IRRIGATION SOLUTION 1.5% W/V B.BRAUN MELSUNGEN<br />

AG<br />

SOLUTION FOR<br />

INJECTION<br />

(*) For the text of Annex XI see OJ L 236, 23.9.2003, p. 859.<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

GERMANY<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 451<br />

Trade Name Dosage Form Dose MA Holder Country<br />

10% CALCIUM CHLORIDE SOLUTION FOR<br />

INJECTION<br />

10% CALCIUM CHLORIDE<br />

INJECTION USP (ABBOJECT<br />

INJECTION)<br />

10% DEXTROSE AND 0.225%<br />

SODIUM CHLORIDE US<br />

10% DEXTROSE AND 0.225%<br />

SODIUM CHLORIDE INJECTION<br />

USP<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

10% DEXTROSE INJECTION USP SOLUTION FOR<br />

INJECTION<br />

10% DEXTROSE INJECTION USP SOLUTION FOR<br />

INJECTION<br />

10% MANNITOL I.V. INJECTION SOLUTION FOR<br />

INJECTION<br />

10% MANNITOL IV INJECTION SOLUTION FOR<br />

INJECTION<br />

10% MANNITOL IV INJECTION<br />

USP<br />

10% W/V CALCIUM GLUCONATE<br />

INJECTION BP<br />

10% W/V GLUCOSE<br />

INTRAVENOUS INFUSION BP<br />

10%DEXTROSE AND 0.225%<br />

SODIUM CHLORIDE INJ<br />

SOLUTION FOR<br />

INJECTION<br />

100MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

100MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

NA ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

100MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

10% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

100MG/ML ABBOTT LABORATORIES<br />

LTD.<br />

UNITED STATES OF<br />

AMERICA<br />

10% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

10% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

INJECTION SOLUTION 10% W/V B.BRAUN MELSUNGEN<br />

AG<br />

INFUSION SOLUTION 10% W/V B.BRAUN MELSUNGEN<br />

AG<br />

SOLUTION FOR IV<br />

INJECTION<br />

GERMANY<br />

GERMANY<br />

N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

1G VENA N I.V. 2.5G/50ML SOL FOR I.V INF 2.5G/50ML KEDRION S.P.A. ITALY<br />

1G VENA N I.V SOL FOR IV INF 10G/200ML KEDRION S.P.A. ITALY<br />

1G VENA N I.V. 1G/20ML SOL FOR IV INF 1G/20ML KEDRION S.P.A. ITALY<br />

1G VENA N I.V. 5G/100ML SOL FOR IV INF 5G/100ML KEDRION S.P.A. ITALY<br />

2% LIDOCAINE HCL INJECTION<br />

USP<br />

SOLUTION FOR<br />

INJECTION<br />

20MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

2% W/V LIDOCAINE INJECTION INJECTION SOLUTION 2% W/V B.BRAUN MELSUNGEN<br />

AG<br />

20% DEXTROSE INJECTION USP SOLUTION FOR<br />

INJECTION<br />

20% DEXTROSE INJECTION, USP SOLUTION FOR IV<br />

INJECTION<br />

20% MANNITOL IV INJECTION SOLUTION FOR<br />

INJECTION<br />

20% MANNITOL IV INJECTION<br />

USP<br />

20% W/V CALCIUM GLUCONATE<br />

INJECTION BP<br />

20% W/V GLUCOSE<br />

INTRAVENOUS SOLUTION BP<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

GERMANY<br />

20% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

200MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

200MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

20% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

20% W/V B.BRAUN MELSUNGEN<br />

AG<br />

INFUSION SOLUTION 20% W/V B.BRAUN MELSUNGEN<br />

AG<br />

30% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 30% W/V B.BRAUN MELSUNGEN<br />

AG<br />

GERMANY<br />

GERMANY<br />

GERMANY


EN<br />

452 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

37.5%W/V GLUCOSE WITH<br />

ELECTROLYTES IVI<br />

INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

3-CIF POWDER FOR INJECTION 1000MG ELSAAD PHARMA SYRIA<br />

4.2% W/V SODIUM BICARBONATE<br />

IVI BP<br />

40% W/V GLUCOSE INJECTION BP INFUSION SOLUTION<br />

CONCENT<br />

40% W/V GLUCOSE<br />

INTRAVENOUS INFUSION BP<br />

5% DEXTROSE AND 0.225% NACL<br />

INJECTION<br />

5% DEXTROSE AND 0.225%<br />

SODIUM CHLORIDE INJ<br />

5% DEXTROSE AND 0.45% NACL<br />

INJ.<br />

5% DEXTROSE AND 0.45%<br />

SODIUM CHLORIDE INJ<br />

5% DEXTROSE AND 0.9% NACL<br />

INJ.<br />

5% DEXTROSE AND 0.9% SODIUM<br />

CHLORIDE INJ<br />

5% DEXTROSE AND LACTATED<br />

RINGER'S INJ USP<br />

INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

40% W/V B.BRAUN MELSUNGEN<br />

AG<br />

INFUSION SOLUTION 40% W/V B.BRAUN MELSUNGEN<br />

AG<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

NA ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

NA ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

SOLUTION FOR IV INJ N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

SOLUTION FOR<br />

INJECTION<br />

NA ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

SOLUTION FOR IV INJ N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

SOLUTION FOR IV<br />

INFUSION<br />

5% DEXTROSE INJECTION USP SOLUTION FOR<br />

INJECTION<br />

5% DEXTROSE INJECTION, USP SOLUTION FOR<br />

INJECTION<br />

5% W/V GLUCOSE INJECTION BP SOLUTION FOR<br />

INJECTION<br />

5% W/V GLUCOSE INTRAVENOUS<br />

INFUSION BP<br />

5.85% W/V SODIUM CHLORIDE<br />

INJECTION BP<br />

N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

5% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

50MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

5% W/V B.BRAUN MELSUNGEN<br />

AG<br />

INFUSION SOLUTION 5% W/V B.BRAUN MELSUNGEN<br />

AG<br />

SOLUTION FOR<br />

INJECTION<br />

50% DEXTROSE INJECTION USP SOLUTION FOR<br />

INJECTION<br />

50% DEXTROSE INJECTION USP SOLUTION FOR<br />

INJECTION<br />

50% DEXTROSE INJECTION, USP SOLUTION FOR<br />

INJECTION<br />

50% MAGNESIUM SULFATE<br />

INJECTION<br />

50% MAGNESIUM SULFATE<br />

INJECTION, USP<br />

50% MAGNESIUM SULPHATE INJ<br />

USP<br />

5.85% W/V B.BRAUN MELSUNGEN<br />

AG<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

50% W/V ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

50% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

500MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

SOLUTION FOR IV/IM INJ 500MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

4 MEQ MG++/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

50% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

50% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 50% W/V B.BRAUN MELSUNGEN AG GERMANY<br />

50% W/V GLUCOSE INJECTION BP INFUSION SOLUTION<br />

CONCENT<br />

50% W/V B.BRAUN MELSUNGEN AG GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 453<br />

7.45% W/V POTASSIUM<br />

CHLORIDE INJECTION<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SOLUTION FOR<br />

INJECTION<br />

7.45% W/V B.BRAUN MELSUNGEN<br />

AG<br />

70% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 70% W/V B.BRAUN MELSUNGEN<br />

AG<br />

8.4% SODIUM BICARBONATE INJ<br />

USP<br />

8.4% SODIUM BICARBONATE INJ<br />

USP<br />

8.4% SODIUM BICARBONATE<br />

INJECTION,USP<br />

8.4% W/V SODIUM BICARBONATE<br />

INJECTION BP<br />

8.4%W/V SODIUM BICARBONATE<br />

IV INFUSION<br />

AAA MOUTH AND THROAT<br />

SPRAY<br />

GERMANY<br />

GERMANY<br />

SOLUTION F/INJECTION 84MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR IV<br />

INJECTION<br />

INFUSION SOL.<br />

CONCENTRATE<br />

8.4% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

84MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

8.4% W/V B.BRAUN MELSUNGEN<br />

AG<br />

INFUSION SOLUTION 8.4% W/V B.BRAUN MELSUNGEN<br />

AG<br />

GERMANY<br />

GERMANY<br />

OROMUCOSAL SPRAY 1.5MG/SP MANX PHARMA LIMITED UNITED KINGDOM<br />

AB-ACICLOVIR 250 POWDER FOR INJECTION 250MG/VIAL ASTRAPIN PHARMA<br />

GMBH & CO. KG<br />

AB-DICLOFENAC 75 SOLUTION FOR<br />

INJECTION<br />

ABDINE COLD RELIEF POWDER POWDER FOR ORAL<br />

SOLUTION<br />

75MG/3ML ASTRAPIN PHARMA<br />

GMBH & CO.KG<br />

650MG BELL SONS & CO<br />

(DRUGGISTS) LIMITED<br />

AB-ERYTHROMYCIN 1000 POWDER FOR INJECTION 1000MG ASTRAPIN PHARMA<br />

GMBH & CO.KG<br />

AB-HYDROCORTISONE 100 POWDER FOR INJECTION 100MG ASTRAPIN PHARMA<br />

GMBH & CO. KG<br />

ABIDEC DROPS ORAL SOLUTION N/A WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

ABIDEC DROPS ORAL SOLUTION N/A PFIZER CONSUMER<br />

HEALTHCARE<br />

AB-METHYLPREDNISOLONE<br />

ACETATE 40<br />

SUSPENSION FOR<br />

INJECTION<br />

AB-METOCLOPRAMIDE HCL 10 SOLUTION FOR<br />

INJECTION<br />

40MG/ML ASTRAPIN PHARMA<br />

GMBH & CO. KG<br />

10MG/2ML ASTRAPIN PHARMA<br />

GMBH & CO. KG<br />

GERMANY<br />

GERMANY<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

ABSINT 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS<br />

ABSINT 2MG CAPSULE 2MG MEDOCHEMIE LTD CYPRUS<br />

ACCOLATE FILM COATED TABLETS 20MG ZENECA LIMITED UNITED KINGDOM<br />

ACCOLATE FILM COATED TABLETS 40MG ZENECA LIMITED UNITED KINGDOM<br />

ACCOLATE COATED TABLETS 20MG ZENECA LIMITED UNITED KINGDOM<br />

ACESAL TABLETS 300MG GEYMONAT SPA ITALY<br />

ACETAZOLAMIDE 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS<br />

ACETAZOLAMIDE BP 250MG<br />

TABLETS<br />

TABLETS 250MG REMEDICA LTD CYPRUS<br />

ACETAZONE FORTE TAB TABLET N/A TECHNILAB INC. CANADA


EN<br />

454 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ACETOAMINOPHEN (ACAMOL)<br />

TABLETS<br />

ACETYSALICYLIC ACID (ASPIRIN)<br />

300MG<br />

TABLET 500MG TEVA PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

ISRAEL<br />

TABLETS 300MG PHARMAMED LTD. MALTA<br />

ACIC CREME FUR LIPPENHERPES CREAM 50MG/G HEXAL AG GERMANY<br />

ACICLOSTAD CREAM 50MG/1G STADAPHARM GMBH GERMANY<br />

ACICLOSTAD 200 TABLET 200MG STADAPHARM GMBH GERMANY<br />

ACICLOSTAD 800 TABLET 800MG STADAPHARM GERMANY<br />

ACICLOVIR 800MG DISPERSIBLE<br />

TABLETS BP<br />

TABLET 800MG SANOFI WINTHROP<br />

LIMITED<br />

UNITED KINGDOM<br />

ACICLOVIR TABLETS BP 200MG TABLET 200MG SANOFI WINTHROP LTD UNITED KINGDOM<br />

ACICLOVIR TABLETS BP 200MG TABLET 200MG SANOFI WINTHROP<br />

LIMITED<br />

ACICLOVIR TABLETS BP 400MG TABLET 400MG SANOFI WINTHROP<br />

LIMITED<br />

ACICLOVIR TABLETS BP 800MG TABLET 800MG CP PHARMACEUTICALS<br />

LTD<br />

ACIVIR EYE OINTMENT NA CIPLA LIMITED INDIA<br />

ACNE AID SOAP SOAP 6.38% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

ACQUA PER PREPARAZIONI<br />

INIETTABILI<br />

SOLUTION FOR<br />

INJECTION<br />

NA INDUSTRIA<br />

FARMACEUTICA<br />

GALENICA SENESE S.R.L.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ACRICEPT 5MG COATED TABLET 5MG EISAI LIMITED UNITED KINGDOM<br />

ACTAL TABLETS 360MG SEVEN SEAS LIMITED T/A<br />

MERCK CONSUMER<br />

HEALTH<br />

ACT-HIB, VACCIN HAEMOPHILUS<br />

TYPE B CONJU<br />

SOLUTION FOR I.M. & S.<br />

C.<br />

N/A PASTEUR MERIEUX<br />

SERUMS ET VACCINS<br />

ACTIFED DM LINCTUS ORAL SOLUTION N/A GLAXO WELLCOME UK<br />

LIMITED<br />

ACTIFED EXPECTORANT ORAL SOLUTION N/A GLAXO WELLCOME UK<br />

LIMITED<br />

ACTIFED SYRUP SYRUP N/A GLAXO WELLCOME UK<br />

LIMITED<br />

ACTIFED TABLETS TABLETS N/A GLAXO WELLCOME UK<br />

LIMITED<br />

ITALY<br />

UNITED KINGDOM<br />

FRANCE<br />

ACTIFED TABLETS TABLETS N/A GLAXOSMITHKLINE SA BELGIUM<br />

ACTIFED TABLETS TABLETS NA GLAXO WELLCOME<br />

BELGIUM S.A.<br />

ACTILYSE VIALS 50MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

BELGIUM<br />

GERMANY<br />

ACTIVELLE -28 TABLETS TABLET NA NOVO NORDISK A/S DENMARK<br />

ACTONEL FILM-COATED TABLETS 5MG GRUPPO LEPETIT SPA ITALY<br />

ACTONEL FILM-COATED TABLETS 30MG GRUPPO LEPETIT SPA ITALY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 455<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ACTONORM GEL ORAL SUSPENSION N/A WALLACE<br />

MANUFACTURING<br />

CHEMISTS LIMITED<br />

ACTOS TABLETS 15MG TAKEDA EUROPE R&D<br />

CENTRE LIMITED<br />

ACTOS TABLETS 30MG TAKEDA EUROPE R&D<br />

CENTRE LIMITED<br />

ACTRAPID HM 1001U/ML1OML<br />

VIAL<br />

SOLUTION FOR<br />

INJECTION<br />

ACTRAPID HM PENFILL SOLUTION FOR<br />

INJECTION<br />

ACULAR (KETOROLAC<br />

TROMETHAMINE) 0.5%<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

1001UML10MLVIAL NOVO NORDISK DENMARK<br />

100IU/ML NOVO NORDISK A/S DENMARK<br />

EYE DROPS, SOLUTION 0.5% W/V ALLERGAN<br />

PHARMACEUTICALS<br />

(IRELAND) LTD., INC.<br />

ACUPAN TABLETS COATED TABLET 30MG 3M HEALTH CARE<br />

LIMITED<br />

IRELAND<br />

UNITED KINGDOM<br />

ACYCLOVIR DENK 200 TABLETS 200MG E.DENK OHG GERMANY<br />

ACYCLOVIR DENK 400 TABLETS 400MG E.DENK OHG GERMANY<br />

ACYCLOVIR DENK 5% CREAM CREAM 5% E.DENK OHG GERMANY<br />

ACYPRONT EFFERVESCENT TABLETS 200MG HEINRICH MACK NACHF.<br />

GMBH & CO. KG<br />

GERMANY<br />

ADALAT CAPSULE 10MG BAYER PAKISTAN<br />

ADALAT CAPSULE 10MG BAYER PAKISTAN<br />

ADALAT 10 CAPSULE 10MG BAYER VITAL GMBH &<br />

CO. KG<br />

GERMANY<br />

ADALAT LA 30MG RETARD TABLET 33MG BAYER AG GERMANY<br />

ADALAT LA 30MG TABLETS MODIFIED RELEASE<br />

TABLET<br />

30MG BAYER PLC UNITED KINGDOM<br />

ADALAT LA 60MG RETARD TABLET 66MG BAYER AG GERMANY<br />

ADALAT LA 60MG TABLET MODIFIED RELEASE<br />

TABLET<br />

60MG BAYER PLC UNITED KINGDOM<br />

ADALAT RETARD RETARD TABLET 20MG BAYER VITAL GMBH &<br />

CO. KG<br />

GERMANY<br />

ADALAT RETARD TABLET 20MG BAYER PAKISTAN<br />

ADALAT RETARD LACQUER COATED<br />

TABLET<br />

20MG BAYER PAKISTAN<br />

ADALAT RETARD 10MG COATED TABLET 10MG BAYER PLC UNITED KINGDOM<br />

ADCO-AMOXYCILLIN 250MG/5ML SUSPENSION 250MG/5ML ADCOCK INGRAM LTD SOUTH AFRICA<br />

ADCO-AMOXYCILLIN 500MG CAPSULES 500MG ADCOCK INGRAM LTD SOUTH AFRICA<br />

ADCO-LOPERAMIDE TABLET 2MG ADCOCK INGRAM LTD SOUTH AFRICA<br />

ADD-ACTEN TABLET N/A MEDOCHEMIE LTD CYPRUS<br />

ADDITIVA VITAMIN C PINK<br />

GRAPEFRUIT<br />

EFFERVESCENT TABLET 1000MG KRUGER GMBH & CO. KG GERMANY


EN<br />

456 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ADDITRACE CONCENTRATE FOR<br />

INFUSION<br />

ADDITRACE, CONCENTRATE FOR<br />

INFUSION<br />

CONCENTRATE FOR<br />

INFUSION<br />

ADENOCOR INJECTION 3MG/ML SOLUTION FOR<br />

INJECTION<br />

N/A FRESENIUS KABI LIMITED UNITED KINGDOM<br />

N/A FRESENIUS KABI LIMITED<br />

-UK<br />

3MG/ML SANOFI WINTHROP<br />

LIMITED<br />

ADIOS COATED TABLETS NA BROME AND SCHIMMER<br />

LIMITED T/A DIOMED<br />

HERBALS<br />

ADIZEM-XL CAPSULES 120MG MODIFIED RELEASE<br />

CAPSULE<br />

ADIZEM-XL CAPSULES 180MG MODIFIED RELEASE<br />

CAPSULE<br />

ADIZEM-XL CAPSULES 240MG MODIFIED RELEASE<br />

CAPSULE<br />

ADIZEM-XL CAPSULES 300MG MODIFIED RELEASE<br />

CAPSULE<br />

120MG NAPP LABORATORIES<br />

LIMITED<br />

180MG NAPP LABORATORIES<br />

LIMITED<br />

240MG NAPP LABORATORIES<br />

LIMITED<br />

300MG NAPP LABORATORIES<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AD-MUC OINTMENT N/A MERZ+CO. GMBH & CO. GERMANY<br />

ADRENALINE AGUETTANT INJECTABLE SOLUTION 1MG/1ML LABORATOIRE<br />

AGUETTANT<br />

ADRENALINE INJECTION BP<br />

1/1000<br />

ADRENALINE INJECTION BP<br />

1/1000<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

ADRENALINE INJECTION/DEMO SOLUTION FOR<br />

INJECTION<br />

ADRENALINE TARTRATE<br />

INJECTION BP<br />

SOLUTION FOR<br />

INJECTION<br />

1MG/1ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

1.0MG/ML ANTIGEN<br />

PHARMACEUTICALS<br />

FRANCE<br />

IRELAND<br />

IRELAND<br />

1MG/1ML DEMO ABEE GREECE<br />

1 IN 1000 EVANS MEDICAL LIMITED UNITED KINGDOM<br />

ADRIBLASTINA POWDER FOR INJECTION 10MG/VIAL PHARMACIA & UPJOHN<br />

S.P.A.<br />

ADRIBLASTINA POWDER FOR SOLN FOR<br />

INJECTION<br />

ADRIBLASTINA SOLUTION FOR<br />

INJECTION<br />

ADRIBLASTINA SOLUTION FOR<br />

INJECTION<br />

ADRIBLASTINA POWDER AND SOLVENT<br />

FOR IV INJ.<br />

ADRIBLASTINA RTU SOLUTION FOR<br />

INJECTION<br />

ADRIBLASTINA RD SOLUTION FOR<br />

INJECTION<br />

ITALY<br />

50MG PHARMACIA ITALIA S.P.A ITALY<br />

10MG/5ML PHARMACIA ITALIA S.P.A ITALY<br />

50MG/25ML PHARMACIA ITALIA S.P.A ITALY<br />

10MG/5ML PHARMACIA ITALIA S.P.A ITALY<br />

10MG/5ML PHARMACIA & UPJOHN<br />

S.P.A.<br />

50MG/25ML PHARMACIA & UPJOHN<br />

S.P.A.<br />

ADRIBLASTINA RTU POWDER FOR INJECTION 50MG/VIAL PHARMACIA & UPJOHN<br />

S.P.A.<br />

ADULT DIFTAVAX INJECTABLE SUSPENSION N/A PASTEUR MERIEUX FRANCE<br />

ADULT MELTUS DRY TICKLY<br />

COUGHS/CATARRH<br />

ITALY<br />

ITALY<br />

ITALY<br />

ORAL SOLUTION N/A CUPAL LTD UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 457<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ADULT MELTUS CHESTY COUGH<br />

W/DECONGESTANT<br />

ADULT MELTUS CHESTY COUGH<br />

WITH DECONGEST<br />

ADULT MELTUS FOR CHESTY<br />

COUGHS AND CATARRH<br />

ADULT MELTUS FOR DRY TICKLY<br />

COUGHS AND CAT<br />

ORAL SOLUTION N/A CUPAL LTD UNITED KINGDOM<br />

ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM<br />

ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM<br />

ORAL LIQUID N/A CUPAL LIMITED UNITED KINGDOM<br />

ADULT MELTUS NIGHT TIME SYRUP N/A CUPAL LIMITED UNITED KINGDOM<br />

ADVANTAN FATTY OINTMENT 1MG/G SCHERING AG ITALY<br />

ADVANTAN CREAM 1MG/G SCHERING AG ITALY<br />

ADVANTAN OINTMENT 1MG/G SCHERING AG ITALY<br />

ADVANTAN OINTMENT 0.1% W/W SCHERING SPA ITALY<br />

ADVANTAN FATTY OINTMENT 0.1% W/W SCHERING SPA ITALY<br />

ADVANTAN CREAM 0.1% W/W SCHERING SPA ITALY<br />

ADVIL TABLETS 200MG WHITEHALL<br />

INTERNATIONAL INC.<br />

CANADA<br />

ADVIL COLD AND SINUS CAPLETS TABLET N/A WHITEHALL-ROBINS INC. CANADA<br />

ADVIL IBUPROFEN TAB 200MG TABLETS 200MG WHITEHALL-ROBINS INC. CANADA<br />

A-E-MULSIN FORTE EMULSION N/A MUCOS PHARMA GMBH<br />

& CO.<br />

AERANNE LIQUID FOR<br />

INHALATION<br />

100% V/V PHARMACIA<br />

LABORATORIES LIMITED<br />

AERIUS FILM-COATED TABLETS 5MG SCHERING-PLOUGH<br />

S.P.A.<br />

AERIUS FILM-COATED TABLETS 5MG SCHERING-PLOUGH<br />

S.P.A.<br />

AEROCROM INHALER MET. DOSE PRESS.<br />

AEROSOL<br />

N/A FISONS LIMITED T/A<br />

RHONE-POULENC RORER<br />

AEROCROM INHALER AEROSOL N/A FISONS LTD T/A RHONE-<br />

POULENC RORER<br />

AERODIOL NASAL SPRAY SOLUTION 150MCG/DOSE LES LABORATOIRES<br />

SERVIER<br />

AEROLID NEBULIZER SOLUTION 0.1% W/V VECCHI & C. PIAM<br />

S.A.P.A.<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

AERO-OM TABLET 40MG OM PORTUGUESA PORTUGAL<br />

AERO-OM ORAL SOLUTION 100MG/ML OM PORTOGUESA PORTUGAL<br />

AERO-OM TABLET 40MG OM PORTUGUESA PORTUGAL<br />

AERO-OM ORAL SOLUTION 100MG/ML OM PORTUGUESA PORTUGAL<br />

AETHOXYSKLEROL 0.5% SOLUTION FOR<br />

INJECTION<br />

AETHOXYSKLEROL 1% SOLUTION FOR<br />

INJECTION<br />

0.5% W/V CHEMISCHE FABRIK<br />

KREUSSLER & CO GMBH<br />

1% W/V CHEMISCHE FABRIK<br />

KREUSSIER & CO GMBH<br />

ITALY<br />

GERMANY<br />

GERMANY


EN<br />

458 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

AETHOXYSKLEROL 2% SOLUTION FOR<br />

INJECTION<br />

AETHOXYSKLEROL 3% SOLUTION FOR<br />

INJECTION<br />

AETHOXYSKLEROL 4% SOLUTION FOR<br />

INJECTION<br />

2% W/V CHEMISCHE FABRIK<br />

KREUSSIER & CO GMBH<br />

3% W/V CHEMISCHE FABRIK<br />

KREUSSIER & CO GMBH<br />

4% W/V CHEMISCHE FABRIK<br />

KREUSSIER & CO GMBH<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

AETHROMA-30 TIME RELEASE TABLETS 30MG MEPHA PHARMA AG SWITZERLAND<br />

AFLOXAN CAPSULE 150MG ROTTA RESEARCH<br />

LABORATORIUM SPA<br />

AFLOXAN CREAM 5% W/W ROTTAPHARM S.R.L ITALY<br />

AFRAZINE NASAL SPRAY 0.05% NASAL SPRAY 0.05% W/V SCHERING-PLOUGH<br />

LIMITED<br />

AGELMIN TABLETS 10MG KLEVA LTD. GREECE<br />

AGGRASTAT 0.25MG/ML CONC. FOR SOLN. FOR<br />

INFUS<br />

AGIOLAX POWDER FOR ORAL<br />

SUSP.<br />

0.25MG/ML MERCK SHARP & DOHME<br />

B.V.<br />

ITALY<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

NA MADAUS AG GERMANY<br />

AGRIMONY (BACH) ORAL LIQUID N/A NELSON A. & CO LTD UNITED KINGDOM<br />

AILAX ORAL SUSPENSION N/A GALEN LIMITED UNITED KINGDOM<br />

AIMAFIX D.I. SOLUTION FOR IV N/A ISTITUTO<br />

SIEROVACCINOGENO<br />

ITALIANO I.S.I. S.P.A.<br />

AIMKIN (BB-K8) INJECTABLE SOLUTION 500MG/2ML BRISTOL MYERS SQUIBB<br />

S.P.A<br />

AIRCORT NASAL SPRAY 100MCG ITALCHIMICI SPA ITALY<br />

AIRCORT SUSPENSION FOR<br />

INHALATION<br />

ITALY<br />

ITALY<br />

40MG ITALCHIMICI SPA ITALY<br />

AKAMIN TABLET 50MG ALPHAPHARM PTY<br />

LIMITED<br />

AKAMIN CAPSULE 100MG ALPHAPHARM PTY<br />

LIMITED<br />

AUSTRALIA<br />

AUSTRALIA<br />

AKAMON 1.5MG TABLET 1.5MG MEDOCHEMIE LTD CYPRUS<br />

AKAMON 3MG TABLET 3MG MEDOCHEMIE LTD CYPRUS<br />

AKAMON 6MG TABLET 6MG MEDOCHEMIE LTD CYPRUS<br />

AKATINOL MEMANTINE TABLETS 10 MG MERZ + CO. GMBH & CO. GERMANY<br />

AKILEN 40MG TABLET 40MG MEDOCHEMIE LTD CYPRUS<br />

AKLONIL 0.5MG TABLET 0.5MG MEDOCHEMIE LTD CYPRUS<br />

AKLONIL 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS<br />

AKTIFERRIN-F SUSCAPS N/A MEPHA PHARMA AG SWITZERLAND<br />

ALBUMIN 20% — GCPD 50ML SOLUTION FOR<br />

INJECTION<br />

ALBUMIN PHARMACIA SOLUTION FOR<br />

INFUSION<br />

20% GREENCROSS PLASMA<br />

DERIVATIVES CORP.<br />

N/A PHARMACIA & UPJOHN<br />

AB<br />

KOREA REPUBLIC<br />

SWEDEN


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 459<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ALBUMIN PHARMACIA SOLUTION FOR<br />

INFUSION<br />

ALCITON METER DOSE NASAL<br />

SPRAY<br />

200MG/ML BIOVITRUM AB SWEDEN<br />

100IU/DOSE KLEVA LIMITED GREECE<br />

ALDACTIDE COATED TABLET N/A MONSANTO PLC UNITED KINGDOM<br />

ALDACTIDE 25 TABLETS N/A MONSANTO PLC T/A<br />

SEARLE<br />

ALDACTONE TABLETS 100MG MONSANTO PLC T/A<br />

SEARLE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ALDACTONE COATED TABLET 25MG MONSANTO PLC UNITED KINGDOM<br />

ALDACTONE COATED TABLETS 100MG MONSANTO PLC T/A<br />

SEARLE<br />

ALDACTONE TABLETS 25MG MONSANTO PLC T/A<br />

SEARLE<br />

ALDACTONE TABLETS 100MG MONSANTO PLC T/A<br />

SEARLE<br />

ALDACTONE TABLETS 100MG MONSANTO PLC T/A<br />

SEARLE<br />

ALDACTONE TABLET 25MG MONSANTO PLC T/A<br />

SEARLE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ALDACTONE 100 MG TABLETS COATED TABLET 100 MG PHARMACIA LIMITED UNITED KINGDOM<br />

ALDACTONE 100MG TABLET 100MG SEARLE PAKISTAN<br />

ALDACTONE 25 MG TABLETS COATED TABLET 25 MG PHARMACIA LIMITED UNITED KINGDOM<br />

ALDACTONE A TABLET 25MG SEARLE PAKISTAN<br />

ALDARA CREAM NA 3M HEALTHCARE<br />

LIMITED<br />

ALDIX 40MG TABLET 40MG MEDOCHEMIE LTD CYPRUS<br />

ALDOMET TABLET 250MG M.S.D. PAKISTAN<br />

ALDOMET 250MG TABLET 250MG MERCK SHARP & DOHME<br />

B.V.<br />

EUROPEAN COMMUNITY<br />

NETHERLANDS<br />

ALDOMET TABLETS TABLETS 250MG MSD PAKISTAN<br />

ALENOST TABLET 10MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

ALEXAN SOLUTION FOR<br />

INJECTION<br />

INDIA<br />

NA HEINRICH MACK NACHF GERMANY<br />

ALFACALCIDOL (ALPHA D3) CAPSULE 1MCG TEVA PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

ALFACIP-0.25MCG CAPSULES CAPSULES 0.25MCG CIPLA LTD. INDIA<br />

ISRAEL<br />

ALFINOR 8MG TABLET 8MG MEDOCHEMIE LTD CYPRUS<br />

ALFOXAN CAPSULES 250MG REMEDICA LTD CYPRUS<br />

ALFOXAN SYRUP 50MG/5ML REMEDICA LTD CYPRUS<br />

ALFOXAN 500 F.C. TABLETS 500MG REMEDICA LTD CYPRUS


EN<br />

460 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ALGESAL SURACTIVE CREAM N/A LABORATOIRES SOLVAY<br />

PHARMA<br />

ALGICON TABLET N/A RORER<br />

PHARMACEUTICALS LTD.<br />

FRANCE<br />

UNITED KINGDOM<br />

ALGIPAN CREAM N/A WYETH-LEDERLE PAKISTAN<br />

A-LICES SHAMPOO NA HOE PHARMACEUTICALS<br />

SDN BHD<br />

A-LICES SCALP AND BODY<br />

HYGIENE SHAMPOO<br />

SHAMPOO 1% W/V HOE PHARMACEUTICALS<br />

SDN. BHD<br />

ALKA-SELTZER EFFERVESCENT TABLET 324MG BAYER VITAL GMBH &<br />

CO. KG<br />

ALKA-SELTZER EFFERVESCENT<br />

TABLETS<br />

EFFERVESCENT TABLET N/A BAYER DIAGNOSTICS<br />

MANUFACTURING<br />

LIMITED<br />

ALKA-SELTZER ORIGINAL EFFERVESCENT TABLET N/A BAYER DIAGNOSTICS<br />

MANUFACTURING<br />

LIMITED<br />

ALKERAN COMPRESSION-COATED<br />

TABLET<br />

ALKERAN COMPRESSION-COATED<br />

TABLET<br />

2MG WELLCOME<br />

FOUNDATION LTD.<br />

5MG WELLCOME<br />

FOUNDATION LTD.<br />

ALKERAN POWDER FOR INJECTION 50MG WELLCOME<br />

FOUNDATION LTD.<br />

ALKERAN COATED TABLET 2MG THE WELLCOME<br />

FOUNDATION LTD. T/A<br />

GLAXO WELLCOME<br />

ALKERAN COATED TABLETS 2MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

ALKERAN POWDER AND SOLVENT<br />

F/SOLUTION F/INJECTION<br />

MALAYSIA<br />

MALAYSIA<br />

NA GLAXOSMITHKLINE SPA ITALY<br />

ALLERGAN CREAM 2G/100G SPA ITALIANA<br />

LABORATORI BOUTY<br />

ALLERGO-COMOD EYE DROPS 20MG/ML URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

ALLERGOCROM SOLUTION, EYE DROPS 20MG/ML URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

ALLERGOPOS N EYE DROPS N/A URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

ALLO-100 TABLET TABLET 100MG CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

ALLOPURINOL TABLETS 300MG DANBURY PHARMACAL<br />

INC.<br />

ALLOPURINOL TABLETS 100MG TABLETS 100MG NORTON HEALTHCARE<br />

LIMITED<br />

ALLOPURINOL TABLETS 300MG TABLETS 300MG NORTON HEALTHCARE<br />

LIMITED<br />

ALLOPURINOL TABLETS BP TABLETS 100MG CP PHARMACEUTICALS<br />

LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

MALAYSIA<br />

PUERTO RICO<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ALLOPURINOL TABLETS BP TABLETS 300MG CP PHARMACEUTICALS UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 461<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ALLOPURINOL TABLETS BP<br />

100MG<br />

ALLOPURINOL TABLETS BP<br />

300MG<br />

TABLETS 100MG CP PHARMACEUTICALS<br />

LTD<br />

TABLET 300MG CP PHARMACEUTICALS<br />

LTD<br />

ALLUMAG MPS SUSPENSION SUSPENSION N/A CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

ALLUPOL TABLET 100MG GRODZISK<br />

PHARMACEUTICAL<br />

WORKS POLFA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

POLAND<br />

ALMIRAL 100MG SUPPOSITORY 100MG MEDOCHEMIE LTD CYPRUS<br />

ALMIRAL 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS<br />

ALMIRAL 50MG TABLET 50MG MEDOCHEMIE LTD CYPRUS<br />

ALMIRAL 50MG SUPPOSITORY 50MG MEDOCHEMIE LTD CYPRUS<br />

ALMIRAL 75MG/3ML LIQUID FOR INJECTION 75MG/3ML MEDOCHEMIE LTD CYPRUS<br />

ALMIRAL SR 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS<br />

ALMORA POWD. FOR ORAL SD. 5.9G/SACHET ELPEN S.A. GREECE<br />

ALOMIDE OPHTHALMIC SOLUTION 1MG/ML S.A. ALCON-COUVREUR<br />

N.V.<br />

ALOPEXY 2% SOLUTN. FOR<br />

CUTANEOUS USE<br />

2% W/V LABORATOIRES PIERRE<br />

FABRE DERMATOLOGIE<br />

BELGIUM<br />

FRANCE<br />

ALOPRON 100 TABLETS 100MG REMEDICA LTD CYPRUS<br />

ALOPRON 300 TABLETS 300MG REMEDICA LTD CYPRUS<br />

ALPHA D3 (ALFACALCIDOL) CAPSULE 0.25MCG TEVA PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

ALPHADINE FILM-COATED TABLETS 150MG MINERVA<br />

PHARMACEUTICAL S.A.<br />

ALPHAGAN (BRIMONIDINE<br />

TARTRATE) 0.2%<br />

ALPHAMOX POWDER FOR ORAL<br />

LIQUID<br />

ALPHAMOX POWDER FOR ORAL<br />

LIQUID<br />

OPHTHALMIC SOLUTION 0.2% W/V ALLERGAN<br />

PHARMACEUTICALS<br />

(IRELAND) LTD., INC.<br />

125MG/ML ALPHAPHARM PTY<br />

LIMITED<br />

250MG/ML ALPHAPHARM PTY<br />

LIMITED<br />

ALPHAMOX 250 CAPSULE 250MG ALPHAPHARM PTY<br />

LIMITED<br />

ALPHAMOX 500 CAPSULE 500MG ALPHAPHARM PTY<br />

LIMITED<br />

ALPHOSYL CREAM N/A STAFFORD-MILLER<br />

LIMITED<br />

ALPHOSYL 2 IN 1 SHAMPOO 5% W/W STAFFORD-MILLER<br />

LIMITED<br />

ALPHOSYL 2 IN 1 SHAMPOO SHAMPOO 5%W/W STAFFORD MILLER<br />

LIMITED<br />

ALPHOSYL CREAM CREAM NA STAFFORD MILLER<br />

LIMITED<br />

ISRAEL<br />

GREECE<br />

IRELAND<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

462 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ALPHOSYL HC CREAM N/A STAFFORD-MILLER<br />

LIMITED<br />

ALPHOSYL HC CREAM CREAM NA STAFFORD-MILLER<br />

LIMITED<br />

ALPHOSYL LOTION TOPICAL EMULSION N/A STAFFORD-MILLER<br />

LIMITED<br />

ALPHOSYL LOTION TOPICAL EMULSION NA STAFFORD MILLER<br />

LIMITED<br />

ALPRENOLOL HCL BP 50MG TABLETS 50MG REMEDICA LTD CYPRUS<br />

ALUDROX LIQUID ORAL GEL 4.16% W/W UNICLIFFE LIMITED T/A<br />

PFIZER CONSUMER<br />

HEALTHCARE<br />

ALUMINIUM HYDROXIDE<br />

SOLVENT<br />

SOLVENT F/PARENTERAL<br />

USE<br />

1MG/0.5ML CHIRON S.P.A ITALY<br />

ALUTRIL CHEWABLE TABLETS N/A REMEDICA LTD CYPRUS<br />

ALVEOFACT SUSPENSION 54MG/1.2ML BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

ALVERCOL GRANULES GRANULES N/A NORGINE LIMITED UNITED KINGDOM<br />

ALVERIX 5 TABLETS 5MG REMEDICA LTD CYPRUS<br />

ALVITYL COATED TABLET N/A LABORATOIRES SOLVAY<br />

PHARMA<br />

ALVITYL SYRUP N/A LABORATOIRES SOLVAY<br />

PHARMA<br />

ALYRANE INHALATION LIQUID 99.9% W/V PHARMACIA<br />

LABORATORIES LIMITED<br />

AMAREL 1MG TABLET 1MG LABORATOIRES<br />

HOECHST<br />

AMAREL 2MG TABLET 2MG LABORATOIRES<br />

HOECHST<br />

AMAREL 3MG TABLET 3MG LABORATOIRES<br />

HOECHST<br />

AMAREL 4MG TABLET 4MG LABORATOIRES<br />

HOECHST<br />

AMBISONE POWDER FOR INJECTION 50MG NEXSTAR<br />

PHARMACEUTICALS LTD.<br />

AMBISONE LYOPH. PWDR. FOR IV<br />

INF<br />

50MG GILEAD SCIENCES<br />

INTERNATIONAL LTD<br />

FRANCE<br />

FRANCE<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

IRELAND<br />

IRELAND<br />

AMBROHEXAL RETARD SLOW RELEASE CAPSULE 75MG HEXAL AG GERMANY<br />

AMBROHEXAL SAFT SOLUTION 3MG/ML HEXAL AG GERMANY<br />

AMBROLITIC SYRUP 300MG/100ML CHIESI WASSERMANN<br />

S.A.<br />

AMBROLITIC 20 CAPSULE 30MG CHIESI WASSERMANN<br />

S.A.<br />

AMBROLITIC 20 CAPSULES 30MG CHIESI ESPANA S.A. SPAIN<br />

AMBROLITIC SYRUP SYRUP 328.9MG/100ML CHIESI ESPANA S.A. SPAIN<br />

SPAIN<br />

SPAIN


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 463<br />

Trade Name Dosage Form Dose MA Holder Country<br />

AMEN 100MG TABLETS TABLETS 100MG MEDOCHEMIE LTD. —<br />

CYPRUS<br />

AMERSCAN (DMSA) AGENT POWDER FOR INJECTION 1MG/VIAL NYCOMED AMERSHAM<br />

PLC<br />

AMERSCAN MEDRONATE II<br />

AGENT<br />

POWDER FOR INJECTION 6.25MG/VIAL NYCOMED AMERSHAM<br />

PLC<br />

AMERSCAN PENTETATE II POWDER FOR INJECTION 20.6MG/10ML NYCOMED AMERSHAM<br />

PLC<br />

AMERSCAN STANNOUS AGENT POWDER FOR INJECTION 4MG/VIAL NYCOMED AMERSHAM<br />

PLC<br />

A-METHAPRED POWDER FOR INJ. WITH<br />

SOLV<br />

CYPRUS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

40MG/VIAL ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

AMICLAV TABLETS 250/125 MG FILM COATED TAB GENERICS (UK) LIMITED UNITED KINGDOM<br />

AMIDATE (SINGLE DOSE AMPUL) SOLUTION FOR<br />

INJECTION<br />

AMIDATE (SINGLE DOSE FLIPTOP<br />

VIAL)<br />

SOLUTION FOR<br />

INJECTION<br />

AMIDATE INJECTION SOLUTION FOR<br />

INJECTION<br />

20MG (2MG/ML) ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

20MG (2MG/ML) ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

2MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

AMIKACINE MERCK 500MG POWDER FOR INJECTION 500MG/VIAL MERCK GENERIQUES FRANCE<br />

AMIKALEM SOLUTION FOR<br />

INJECTION<br />

100MG/250MG/500 LEMERY S.A. DE C.V MEXICO<br />

AMIKIN INJECTABLE SOLUTION 500MG/2ML BRISTOL-MYERS SQUIBB<br />

EESTI AS<br />

AMIL-CO TABLETS TABLETS N/A NORTON HEALTHCARE<br />

LIMITED<br />

ESTONIA<br />

UNITED KINGDOM<br />

AMILORETIC TABLET N/A PHARMACARE LIMITED SOUTH AFRICA<br />

AMILORIDE HCL TABLETS 5MG TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

AMILORIDE TABLETS BP TABLETS 5MG CP PHARMACEUTICALS<br />

LTD.<br />

AMILORIDE TABLETS BP 5MG TABLET 5MG CP PHARMACEUTICALS<br />

LTD<br />

AMINOPHYLLIN IV-FRESENIUS SOLUTION FOR<br />

INJECTION<br />

AMINOPHYLLINE SOLUTION FOR<br />

INJECTION<br />

250MG/10ML BODENE (PROPIETARY)<br />

LIMITED T/A INTRAMED-<br />

SOUTH AFRICA<br />

250MG/10ML DEMO ABEE GREECE<br />

AMINOPHYLLINE TABLETS 225MG NORTON HEALTHCARE<br />

LIMITED<br />

AMINOPHYLLINE SOLUTION FOR<br />

INJECTION<br />

250MG PHARMAMED<br />

PARENTERALS LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SOUTH AFRICA<br />

UNITED KINGDOM<br />

MALTA<br />

AMINOPHYLLINE BP 250MG TABLETS 250MG REMEDICA LTD CYPRUS<br />

AMINOPHYLLINE BP 360MG SUPPOSITORIES 360MG REMEDICA LTD CYPRUS<br />

AMINOPHYLLINE INJECTION<br />

240MG BP<br />

INJECTION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

GERMANY


EN<br />

464 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

AMINOPHYLLINE INJECTION BP SOLUTION FOR<br />

INJECTION<br />

AMINOPHYLLINE INJECTION BP SOLUTION FOR<br />

INJECTION<br />

AMINOPHYLLINE INJECTION BP<br />

MINIJET<br />

AMINOPHYLLINE INJECTION<br />

MINIJET<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

AMINOPHYLLINE MINJET SOLUTION FOR<br />

INJECTION<br />

250MG/10ML EVANS MEDICAL LIMITED UNITED KINGDOM<br />

250MG/10ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

N/A INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

N/A INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

N/A INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

AMINOPHYLLINE TABLETS 100MG TABLET 100MG NORTON<br />

PHARMACEUTICALS<br />

LIMITED<br />

AMINOPLASMAL 10% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

AMINOPLASMAL 10% E INFUSION SOLTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

AMINOPLASMAL 12.5% E INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

AMINOPLASMAL 15% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

AMINOPLASMAL 15% E INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

AMINOPLASMAL 5% E INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

AMINOPLASMAL HEPA 10% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

AMINOSYN 10% SOLUTION SOL. FOR I.V. INFUSION N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

AMINOSYN 8.5% WITH<br />

ELECTROLYTES<br />

SOLUTION FOR<br />

INJECTION<br />

N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

AMINOSYN II 10% INJECTION SOL. FOR I.V. INJECTION N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

AMINOSYN II 4.25% M IN 10%<br />

DEXTROSE INJ.<br />

SOLUTION FOR<br />

INJECTION<br />

N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

AMIODARONE 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS<br />

AMIROL 10 TABLETS 10MG REMEDICA LTD CYPRUS<br />

AMIROL 25 TABLETS 25MG REMEDICA LTD CYPRUS<br />

AMITRIPTYLIN SLOVAKOFARMA TABLETS 0.028300G SLOVAKOFARMA SLOVAK REPUBLIC<br />

AMITRIPTYLINE SUGAR COATED<br />

TABLETS<br />

25MG EXTRACTUM-PHARMA<br />

CO. LTD<br />

AMITRIPTYLINE TABLET 25MG TABLET 25MG CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

HUNGARY<br />

MALAYSIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 465<br />

Trade Name Dosage Form Dose MA Holder Country<br />

AMITRYPTYLLIN COATED TABLET 25MG ICN POLFA RZESZOW<br />

S.A. PHARMACEUTICAL<br />

WORKS<br />

POLAND<br />

AMLO 10 MG, TABLETS TABLETS 10 MG OMEGA FARMA EHF ICELAND<br />

AMLO 2.5 MG, TABLETS TABLETS 2.5 MG OMEGA FARMA EHF. ICELAND<br />

AMLO 5 MG, TABLETS TABLETS 5 MG OMEGA FARMA EHF. ICELAND<br />

AMOCLAN TABLETS 375MG HIKMA<br />

PHARMACEUTICALS<br />

AMOCLAN POWDER FOR INJECTION NA HIKMA<br />

PHARMACEUTICALS<br />

AMOX CAPSULE 250MG CAPSULE 250MG CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

JORDAN<br />

JORDAN<br />

MALAYSIA<br />

AMOXAPEN 125 ORAL SUSPENSION 125MG/5ML REMEDICA LTD CYPRUS<br />

AMOXAPEN 250 CAPSULES 250MG REMEDICA LTD CYPRUS<br />

AMOXAPEN 250 ORAL SUSPENSION 250MG/5ML REMEDICA LTD CYPRUS<br />

AMOXAPEN 250 F.C. TABLETS 250MG REMEDICA LTD CYPRUS<br />

AMOXAPEN 500 CAPSULES 500MG REMEDICA LTD CYPRUS<br />

AMOXAPEN 500 F.C. TABLETS 500MG REMEDICA LTD CYPRUS<br />

AMOXICILLIN CAPSULES 250MG CAPSULE 250MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

AMOXICILLINE CAPSULE 250MG PHARMACEUTICAL<br />

WORKS POLFA-KRAKOW<br />

S.A.<br />

AMOXICILLIN-RATIOPHARM<br />

250 TS<br />

GRANULES FOR ORAL<br />

SUSPN.<br />

POLAND<br />

250MG/5ML RATIOPHARM GMBH GERMANY<br />

AMOXICILLIN-RATIOPHARM 500 FILM COATED TABLETS 500MG RATIOPHARM GMBH GERMANY<br />

AMOXICOMP,,GENERICON FILM COATED TABLET 625 MG GENERICON PHARMA<br />

GES.M.B.H.<br />

GERMANY<br />

AMOXIHEXAL 500 FILM-COATED TABLET 500MG HEXAL AG GERMANY<br />

AMOXIHEXAL SAFT DRY SUBSTANCE FOR<br />

SUSP<br />

200MG/5ML HEXAL AG GERMANY<br />

AMOXIL CAPSULE 250MG SMITH KLINE BEECHAM PAKISTAN<br />

AMOXIL CAPSULE 500MG SMITH KLINE BEECHAM PAKISTAN<br />

AMOXIL SYRUP IN POWDER<br />

FORM<br />

125MG/5ML SMITH KLINE &<br />

BEECHAM<br />

AMOXIL CAPSULE 250MG SMITH KLINE &<br />

BEECHAM<br />

AMOXIL CAPSULE 500MG SMITH KLINE &<br />

BEECHAM<br />

PAKISTAN<br />

PAKISTAN<br />

PAKISTAN<br />

AMOXIL CAPSULES 250MG CAPSULE 250MG BEECHAM GROUP PLC UNITED KINGDOM<br />

AMOXIL CAPSULES 500MG CAPSULE 500MG BEECHAM GROUP PLC UNITED KINGDOM<br />

AMOXIL FORTE SYRUP IN POWDER<br />

FORM<br />

250MG/5ML SMITH KLINE &<br />

BEECHAM<br />

PAKISTAN


EN<br />

466 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

AMOXIL PAEDIATRIC<br />

SUSPENSION<br />

AMOXIL SACHET 3G<br />

SUCROSE-FREE<br />

Trade Name Dosage Form Dose MA Holder Country<br />

AMOXIL SYRUP SUCROSE-FREE<br />

SUSPENSION<br />

AMOXIL SYRUP SUCROSE-FREE<br />

SUSPENSION<br />

AMOXIL VIALS FOR INJECTION<br />

250MG<br />

AMOXIL VIALS FOR INJECTION<br />

500MG<br />

POWDER FOR ORAL<br />

SOLUTION<br />

GRANULES FOR ORAL<br />

SOLN.<br />

POWDER FOR ORAL<br />

SUSPEN.<br />

POWDER FOR ORAL<br />

SUSPEN.<br />

125MG/1.25ML BEECHAM GROUP PLC UNITED KINGDOM<br />

3G BEECHAM GROUP PLC UNITED KINGDOM<br />

125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM<br />

250MG/5ML BEECHAM GROUP PLC UNITED KINGDOM<br />

POWDER FOR INJECTION 250MG BEECHAM GROUP PLC UNITED KINGDOM<br />

POWDER FOR INJECTION 500MG BEECHAM GROUP PLC UNITED KINGDOM<br />

AMOXYCILLIN CAPSULES 250MG NORTON<br />

PHARMACEUTICALS<br />

LIMITED<br />

AMOXYCILLIN CAPSULES 500MG NORTON<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

IRELAND<br />

AMOXYCILLIN CAPSULE 250MG PLIVA PAKISTAN<br />

AMOXYCILLIN 3GM SACHETS S.F. POWDER FOR ORAL<br />

SOLUTION<br />

AMOXYCILLIN CAPSULES<br />

B.P.500MG<br />

3GM NORTON HEALTHCARE<br />

LIMITED<br />

CAPSULES 500MG ATHLONE<br />

LABORATORIES LIMITED<br />

AMOXYCILLIN MIXTURE ORAL SOLUTION 125MG/5ML NORTON HEALTHCARE<br />

LIMITED<br />

AMOXYCILLIN MIXTURE<br />

250MG/5ML<br />

AMOXYCILLIN S/F MIXTURE<br />

125MG/5ML<br />

AMOXYCILLIN S/F MIXTURE<br />

250MG/5ML<br />

AMOXYCILLIN S/F SACHETS POWDER FOR<br />

RECONSTITUTION<br />

AMOXYCILLIN SUGAR FREE<br />

SUSPENSION B.P.<br />

ORAL SOLUTION 250MG/5ML NORTON HEALTHCARE<br />

LIMITED<br />

ORAL SOLUTION 125MG/5ML NORTON HEALTHCARE<br />

LIMITED<br />

ORAL SOLUTION 250MG/5ML NORTON HEALTHCARE<br />

LIMITED<br />

SUGAR FREE<br />

SUSPENSION<br />

3MG/5ML NORTON HEALTHCARE<br />

LIMITED<br />

125MG/5ML ATHLONE<br />

LABORATORIES LIMITED<br />

AMOXYDAR CAPSULES 250MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

AMOXYDAR 125 GRANULES FOR ORAL<br />

SUSPEN.<br />

AMPHOCIL POWDER FOR SOLUTION<br />

FOR INFUSION<br />

125MG/5ML DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD<br />

50MG INTERMUNE EUROPE<br />

LIMITED<br />

AMPICILLIN CAPSULES 250MG CAPSULES 250MG NORTON HEALTHCARE<br />

LIMITED<br />

AMPICILLIN CAPSULES 500MG CAPSULES 500MG NORTON HEALTHCARE<br />

LIMITED<br />

AMPICLLIN CAPSULES B.P. CAPSULES 500MG ATHLONE<br />

LABORATORIES LIMITED<br />

UNITED KINGDOM<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

JORDAN<br />

JORDAN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 467<br />

Trade Name Dosage Form Dose MA Holder Country<br />

AMPICLOX CAPSULE N/A SMITH KLINE &<br />

BEECHAM<br />

PAKISTAN<br />

AMPICLOX CAPSULES 500MG CAPSULE N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AMPICLOX INJECTION 500MG POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AMPICLOX NEONATAL INJECTION POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AMPICLOX NEONATAL<br />

SUSPENSION<br />

POWDER FOR ORAL<br />

SUSPEN.<br />

N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AMPICLOX SYRUP POWDER FOR SYRUP N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AMPISUL 250 CAPSULES 250MG AEGIS LTD. CYPRUS<br />

AMPISUL 500 CAPSULES 500MG AEGIS LTD. CYPRUS<br />

AMSIDINE 50 MG/ML SOLUTION FOR<br />

INJECTION<br />

AMSIDINE INJECTION SOLUTION FOR<br />

INJECTION<br />

50 MG/ML GOLDSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

50MG/ML GOLDSHIELD<br />

PHARMACEUTICALS LTD<br />

AMURETIC TABLETS NA DAR ALA DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

ANABACT METRONIDAZOLE<br />

TOPICAL GEL 0.75%<br />

ANACAINE INJECTION 1% SOLUTION FOR<br />

INJECTION<br />

GEL 0.75% W / W BIOGLAN<br />

PHARMACEUTICALS LTD<br />

10MG/ML SM PHARMACEUTICALS<br />

SDN. BHD.<br />

ANACAL RECTAL OINTMENT RECTAL OINTMENT N/A SANKYO PHARMA UK<br />

LIMITED<br />

ANACAL SUPPOSITORIES SUPPOSITORY N/A SANKYO PHARMA UK<br />

LIMITED<br />

ANADIN TABLETS N/A WHITEHALL<br />

LABORATORIES LTD<br />

ANADIN EXTRA / POWERIN TABLETS N/A WHITEHALL<br />

LABORATORIES LTD<br />

ANADIN PARACETAMOL TABLETS 500MG WHITEHALL<br />

LABORATORIES LTD<br />

ANAFRANIL SUGAR COATED<br />

TABLETS<br />

ANAFRANIL SUGAR COATED<br />

TABLETS<br />

10MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

25MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

JORDAN<br />

UNITED KINGDOM<br />

MALAYSIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

ANAFRANIL TABLET 10MG NOVARTIS PAKISTAN<br />

ANAFRANIL TABLET 25MG GEIGY PAKISTAN<br />

ANAFRANIL TABLET 25MG NOVARTIS PAKISTAN<br />

ANAFRANIL S/C TABLETS 10MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

ANAFRANIL FIM-COATED TABLET 75MG NOVARTIS<br />

FARMACEUTICA S.A. —<br />

SPAIN<br />

ANAFRANIL SUGAR-COATED<br />

TABLETS<br />

10MG NOVARTIS<br />

FARMACEUTICA S.A<br />

SWITZERLAND<br />

SPAIN<br />

SPAIN


EN<br />

468 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ANAFRANIL SUGAR-COATED<br />

TABLETS<br />

ANAFRANIL SUGAR (FILM)-COATED<br />

TABLETS<br />

ANAFRANIL SUGAR (FILM)-COATED<br />

TABLETS<br />

25MG NOVARTIS<br />

FARMACEUTICA S.A<br />

SPAIN<br />

10MG NOVARTIS FARMA SPA ITALY<br />

25MG NOVARTIS FARMA SPA ITALY<br />

ANAFRANIL SR 75 DIVITABS 75MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

ANAPRIN TABLETS TABLETS 75MG OPAL PAKISTAN<br />

ANARGIL 100MG CAPSULE 100MG MEDOCHEMIE LTD CYPRUS<br />

ANARGIL 200MG CAPSULE 200MG MEDOCHEMIE LTD CYPRUS<br />

ANATOXAL DI TE BERNA SOUTION FOR INJECTION N/A ISTITUTO<br />

SIEROTERAPICO BERNA<br />

S.R.L.<br />

ANCID CHEWING TABLET 500MG HEXAL AG GERMANY<br />

ANCOPIR TABLET N/A DR.GROSSMANN AG<br />

PHARMACA<br />

ANCOTIL SOLUTION FOR<br />

INJECTION<br />

ANCOTIL SOLUTION FOR<br />

INJECTION<br />

ANCOTIL 2.5G/250ML SOLUTION FOR<br />

INJECTION<br />

2.5G/250ML ICN PHARMACEUTICALS<br />

LIMITED<br />

2.5G/250ML ICN PHARMACEUTICALS<br />

LIMITED<br />

N/A ICN PHARMACEUTICALS<br />

LIMITED<br />

ITALY<br />

SWITZERLAND<br />

ANDRACTIM GEL N/A BESINS INTERNATIONAL FRANCE<br />

ANDREWS ANTACID TABLETS TABLET N/A SMITHKLINE BEECHAM<br />

(SWG) LTD T/A STERLING<br />

HEALTH<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ANDRIOL CAPSULES 40MG N.V. ORGANON NETHERLANDS<br />

ANDROCUR TABLET 50MG SCHERING AG GERMANY<br />

ANDROCUR TABLET 50MG SCHERING S.A. FRANCE<br />

ANDROCUR-10 TABLET 10MG SCHERING AG GERMANY<br />

ANDROCUR-DEPOT OILY SOLN FOR IM<br />

INJECT.<br />

ANECTINE SOLUTION FOR<br />

INJECTION<br />

ANECTINE SOLUTION FOR<br />

INJECTION<br />

ANECTINE (MIDARINE) SOLUTION FOR<br />

INJECTION<br />

100MG/ML SCHERING AG GERMANY<br />

5%W/V THE WELLCOME<br />

FOUNDATION LIMITED<br />

5%W/W THE WELLCOME<br />

FOUNDATION LIMITED<br />

5% W/V WELLCOME<br />

FOUNDATION LTD.<br />

ANEXATE AQUEOSUS SOLUTION 0.5MG/5ML ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

ANGINESIN LIQUID N/A DR. GROSSMAN AG<br />

PHARMACA<br />

ANGINOVAG AEROSOL N/A LABORATORIOS NOVAG,<br />

S.A.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

SPAIN


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 469<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ANGIOCIS POWDER FOR INJECTION N/A CIS BIO INTERNATIONAL FRANCE<br />

ANGISED TABLETS TABLETS 0.5MG GLAXOWELLCOME PAKISTAN<br />

ANGISED TABLETS TABLETS 0.5MG GLAXOSMITHKLINE<br />

SOUTH AFRICA (PTY)<br />

LTD<br />

ANGISPRAY SPRAY SOLN F/ORAL<br />

CAVITY<br />

SOUTH AFRICA<br />

N/A LABORATOIRES MONOT FRANCE<br />

ANTACID PLUS ANTIFLATULENT SUSPENSION N/A STANLEY<br />

PHARMACEUTICALS LTD<br />

ANTHISAN CREAM 2% W/W CREAM 2% W/W MAY & BAKER LIMITED<br />

(T/A RHONE-POULENC<br />

RORER)<br />

ANTIBIOPTAL EYE DROPS N/A FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

ANTIBIOTIC OINTMENT OINTMENT N/A STANLEY<br />

PHARMACEUTICALS LTD<br />

CANADA<br />

UNITED KINGDOM<br />

ITALY<br />

CANADA<br />

ANTIBLUT S.R.F.C. TABLET 20MG GENEPHARM S.A. GREECE<br />

ANTIDOL COATED TABLETS 500MG LABORATORIOS CINFA<br />

S.A<br />

ANTIGREG TABLET 250MG VECCHI & C PIAM<br />

S.A.P.A.<br />

ANTIGREG TABLET 250MG VECCHI & C PIAM ITALY<br />

ANTILIPID FILM COATED TABLETS 600MG KLEVA LIMITED GREECE<br />

ANTIPEOL OINTMENT OINTMENT N/A MEDICO-BIOLOGICAL<br />

LABS LTD<br />

ANTIPHLOGISTINE PASTE FOR TOPICAL<br />

APPLIC.<br />

N/A LABORATOIRES<br />

FUMOUZE<br />

SPAIN<br />

ITALY<br />

UNITED KINGDOM<br />

FRANCE<br />

ANTIPREX TABLETS 5MG ELPEN PHARM. CO. INC. GREECE<br />

ANTIRRINUM NASAL SPRAY SOLUTION NA LABORATORIO REIG<br />

JOFRE S.A<br />

ANTISPASMINA COLICA GASTRORESISTANT<br />

TABLET<br />

ANTISPASMINA COLICA (FORTE) GASTRORESISTANT<br />

TABLET<br />

ANTITHROMBIN III HUMAN<br />

THROMBHIBIN<br />

SOLUTION FOR<br />

INJECTION<br />

N/A RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

N/A RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

SPAIN<br />

ITALY<br />

ITALY<br />

N/A BAXTER AG AUSTRIA<br />

ANTI-THYROX TABLETS 5MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

ANTORAL SOLUTION FOR BUCCAL<br />

USE<br />

0.05G/100ML RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

ANTORAL LOZENGE (THROAT) 5MG RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

ANUSOL SUPPOSITORY N/A PARKE DAVIS FRANCE<br />

ANUSOL RECTAL OINTMENT N/A PARKE DAVIS FRANCE<br />

INDIA<br />

ITALY<br />

ITALY


EN<br />

470 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ANUSOL SUPPOSITORIES SUPPOSITORY N/A WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

ANXETIN CAPSULES 20MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

UNITED KINGDOM<br />

JORDAN<br />

ANXIOLAN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS<br />

ANZEMET 100MG/5ML SOLUTION FOR IV<br />

INJECTION<br />

ANZEMET 12.5MG/0.625ML SOLUTION FOR IV<br />

INJECTION<br />

100MG/5ML LABORATOIRES AVENTIS FRANCE<br />

12.5MG/0.625ML LABORATOIRES AVENTIS FRANCE<br />

ANZEMET 200MG COATED TABLET 200MG LABORATOIRES<br />

ROUSSEL DIAMANT<br />

APIOCOLINA CREAM 106MG/100G BRUSCHETTINI SRL ITALY<br />

APIOCOLINA SUPPOSITORY 4MG BRUSCHETTINI SRL ITALY<br />

APO ACETAZOLAMIDE<br />

TAB 250MG<br />

FRANCE<br />

TABLET 250MG APOTEX INC CANADA<br />

APO ALLOPURINOL 100MG TABLET 100MG APOTEX INC CANADA<br />

APO AMPI CAPSULES 500MG CAPSULE 500MG APOTEX INC CANADA<br />

APO CIMETIDINE TAB 200MG TABLET 200MG APOTEX INC CANADA<br />

APO FOLIC ACID TAB 5MG TABLET 5MG APOTEX INC CANADA<br />

APO GLYBURIDE TAB 2.5MG TABLET 2.5MG APOTEX INC CANADA<br />

APO IMIPRAMINE TAB 10MG TABLET 10MG APOTEX INC CANADA<br />

APO IMIPRAMINE TAB 25MG TABLET 25MG APOTEX INC CANADA<br />

APO ISDN TABLET 10MG APOTEX INC CANADA<br />

APO PRIMIDONE TABLET 250MG APOTEX INC CANADA<br />

APO SULFATRIM TAB TABLET N/A APOTEX INC CANADA<br />

APO TETRA CAP 250MG CAPSULE 250MG APOTEX INC CANADA<br />

APO THIORIDAZINE TABLET 10MG APOTEX INC CANADA<br />

APO TRIHEX TAB 2MG TABLET 2MG APOTEX INC CANADA<br />

APO ZIDOVUDINE CAP 100MG CAPSULE 100MG APOTEX INC CANADA<br />

APO-ALPRAZ TAB 0.5MG TABLET 0.5MG APOTEX INC CANADA<br />

APO-AMITRIPTYLINE HCL<br />

TAB 25MG<br />

TABLET 25MG APOTEX INC CANADA<br />

APO-AMOXI CAP 500MG CAPSULE 500MG APOTEX INC CANADA<br />

APO-ATENOLOL TABLET 100MG APOTEX INC CANADA<br />

APO-CEPHALEX TAB 500MG TABLET 500MG APOTEX INC CANADA<br />

APO-CLOMIPRAMINE TABLETS<br />

10MG<br />

APO-CLOMIPRAMINE TABLETS<br />

25MG<br />

TABLET 10MG APOTEX INC CANADA<br />

TABLET 25MG APOTEX INC CANADA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 471<br />

Trade Name Dosage Form Dose MA Holder Country<br />

APO-DICLO SR 100MG MODIFIED RELEASE<br />

TABLET<br />

100MG APOTEX INC CANADA<br />

APO-DOXY CAP 100MG CAPSULE 100MG APOTEX INC CANADA<br />

APO-FLUOXETINE — CAP 20MG CAPSULE 20MG APOTEX INC CANADA<br />

APO-GLYBURIDE TAB 5MG TABLET 5MG APOTEX INC CANADA<br />

APO-PREDNISONE 5MG TABLETS TABLET 5MG APOTEX INC CANADA<br />

APO-RANITIDINE 300MG TABLETS 300MG APOTEX INC CANADA<br />

APO-RANITIDINE TAB 150MG TABLET 150MG APOTEX INC CANADA<br />

APRAZOL CAPSULES 30MG HUSNU ARSAN ILACLARI<br />

A.S.<br />

APRAZOL ENTERIC COATED<br />

CAPSULE30M<br />

APRESOLINE SUGAR COATED<br />

TABLETS<br />

APRESOLINE SUGAR COATED<br />

TABLETS<br />

APROTININ INJECTION SOLUTION FOR<br />

INJECTION<br />

30MG HUSNU ARSAN ILACLARI<br />

A.S.- TURKEY<br />

10MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

25MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

10 KIU/ML FERRING<br />

PHARMACEUTICALS LTD<br />

APROVEL 150MG TABETS TABLET 150MG SANOFI PHARMA<br />

BRISTOL-MYERS SQUIBB<br />

SNC<br />

APROVEL 300MG TABLETS TABLET 300MG SANOFI PHARMA<br />

BRISTOL-MYERS SQUIBB<br />

SNC<br />

APROVEL75MG TABLET TABLET 75MG SANOFI PHARMA<br />

BRISTOL-MYERS SQUIBB<br />

SNC<br />

AQUEOUS CREAM BP CREAM 9% W/W ADAMS HEALTHCARE<br />

LIMITED<br />

TURKEY<br />

TURKEY<br />

SWITZERLAND<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

UNITED KINGDOM<br />

AQUEOUS CREAM BP CREAM NO ACTIVE ING. THORNTON & ROSS LTD UNITED KINGDOM<br />

AQUEOUS CREAM BP CREAM N/A RUSCO LIMITED T/A<br />

RUSCO<br />

PHARMACEUTICALS<br />

ARAVA FILM-COATED TABLET 10MG HOECHST MARION<br />

ROUSSEL DEUTSCHLAND<br />

GMBH<br />

ARAVA FILM-COATED TABLET 20MG HOECHST MARION<br />

ROUSSEL DEUTSCHLAND<br />

GMBH<br />

ARAVA FILM-COATED TABLET 100MG HOECHST MARION<br />

ROUSSEL DEUTSCHLAND<br />

GMBH<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

ARCALION TABLETS 200MG SERVIER PAKISTAN<br />

ARCALION 200MG COATED TABLETS SERVIER EGYPT<br />

INDUSTRIES LTD<br />

EGYPT<br />

ARCALION 200MG COATED TABLET 200MG LABORATOIRES SERVIER FRANCE<br />

ARCALION TABLETS TABLETS 200MG SERVIER PAKISTAN


EN<br />

472 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ARCOXIA FILM-COATED TABLETS 120MG MERCK SHARP AND<br />

DOHME LIMITED<br />

ARCOXIA FILM COATED TABLETS 90MG MERCK SHARP & DOHME<br />

LIMITED<br />

ARCOXIA FILM COATED TABLETS 60MG MERCK SHARP & DOHME<br />

LIMITED<br />

AREDIA DRY SUBSTANCE FOR<br />

INJ.<br />

15MG/VIAL NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

AREDIA POWDER FOR INJECTION 30MG/VIAL NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

AREDIA POWDER FOR INJECTION 60MG/VIAL NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

AREDIA POWDER FOR INJECTION 90MG/VIAL NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

AREDIA POWDER FOR INFUSION 15MG NOVARTIS<br />

FARMACEUTICA S.A. —<br />

SPAIN<br />

AREDIA POWDER FOR INFUSION 30MG NOVARTIS<br />

FARMACEUTICA S.A. —<br />

SPAIN<br />

AREDIA POWDER FOR INFUSION 60 MG NOVARTIS<br />

FARMACEUTICA S.A. —<br />

SPAIN<br />

AREDIA POWDER FOR INFUSION 90MG NOVARTIS<br />

FARMACEUTICA S.A. —<br />

SPAIN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

ARESTON TABLETS 50MG MEDOCHEMIE LTD. CYPRUS<br />

ARFEN SUSPENSION 120MG/5ML MEDOCHEMIE LTD CYPRUS<br />

ARFEN 125MG SUPPOSITORY 125MG MEDOCHEMIE LTD CYPRUS<br />

ARFEN 250MG SUPPOSITORY 250MG MEDOCHEMIE LTD CYPRUS<br />

ARFEN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS<br />

ARFEN 500MG SUPPOSITORY 500MG MEDOCHEMIE LTD CYPRUS<br />

ARICEPT 10MG COATED TABLET 10MG EISAI LIMITED UNITED KINGDOM<br />

ARIDIL TABLETS N/A CP PHARMACEUTICALS<br />

LTD.<br />

ARIDIL TABLETS N/A CP PHARMACEUTICALS<br />

LTD.<br />

ARIDIL TABLETS N/A CP PHARMACEUTICALS<br />

LTD.<br />

ARIDIL TABLET N/A CP PHARMACEUTICALS<br />

LTD<br />

ARIDIL TABLET N/A CP PHARMACEUTICALS<br />

LTD<br />

ARIDIL TABLET N/A CP PHARMACEUTICALS<br />

LTD<br />

ARILVAX — YELOW FEVER<br />

VACCINE<br />

SPAIN<br />

SPAIN<br />

SPAIN<br />

SPAIN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL LIMITED UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 473<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ARIMIDEX COATED TABLET 1MG ZENECA LIMITED UNITED KINGDOM<br />

ARISTIN-C INJ.SOLUTION OF<br />

INFUSION<br />

200MG/100ML ANFARM HELLAS S.A. GREECE<br />

ARISTIN-C FILM COATED TABLETS 500MG ANFARM HELLAS S.A. GREECE<br />

ARISTIN-C FILM-COATED TABLET 250MG ANFARM HELLAS S.A GREECE<br />

ARNETIN 150MG TABLET 150MG MEDOCHEMIE LTD CYPRUS<br />

ARNETIN 50MG/2ML LIQUID FOR INJECTION 50MG/2ML MEDOCHEMIE LTD CYPRUS<br />

ARNICA CREAM 9% A NELSON AND<br />

COMPANY LTD<br />

AROMASIN COATED TABLETS 25MG PHARMACIA & UPJOHN<br />

LIMITED<br />

AROMASIN FILM-COATED TABLETS 25MG PHARMACIA ITALIA SPA ITALY<br />

ARPHOS ORAL SOLUTION N/A LABORATORIES<br />

FOURNIER S.A.<br />

UNITED KINGDOM<br />

ITALY<br />

FRANCE<br />

ART CAPSULE 50MG LABORATOIRES NEGMA FRANCE<br />

ART 50 CAPSULES 50MG NEGMA-LERADS FRANCE<br />

ARTANE TABLETS 2MG CYANAMID OF GREAT<br />

BRITAIN LTD.<br />

ARTEX 5MG SCORED COATED<br />

TABLET<br />

5MG LES LABORATOIRES<br />

SERVIER<br />

UNITED KINGDOM<br />

FRANCE<br />

ARTHRINAL F.C. TABLETS 20MG REMEDICA LTD CYPRUS<br />

ARTHROTEC 50 TABLETS N/A MONSANTO PLC UNITED KINGDOM<br />

ARTHROTEC 50 TABLETS GASTRO-RESISTANT<br />

TABLETS<br />

ARTHROTEC 50 TABLETS GASTRO-RESISTANT<br />

TABLET<br />

N/A MONSANTO PLC T/A<br />

SEARLE<br />

UNITED KINGDOM<br />

N/A PHARMACIA LIMITED UNITED KINGDOM<br />

ARTHROTEC 75 TABLETS N/A MONSANTO PLC T/A<br />

SEARLE<br />

ARTHROTEC 75 GASTRO RESISTANT<br />

TABLET<br />

NA MONSANTO PLC T/A<br />

SEARLE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ARTHROTEC TABLETS TABLETS NA SEARLE PAKISTAN<br />

ARTHROXEN TABLET 250MG CP PHARMACEUTICALS<br />

LTD<br />

ARTHROXEN TABLET 500MG CP PHARMACEUTICALS<br />

LIMITED<br />

ARTROSILENE FOAM N/A DOMPE FARMACEUTICI<br />

SPA<br />

ARTROSILENE GEL N/A DOMPE FARMACEUTICI<br />

SPA<br />

ARTROSILENE ‘RETARD’ CAPSULES 320MG DOMPE FARMACEUTICI<br />

SPA<br />

ARTROXICAM CAPSULE 20MG FONTEN FARMACEUTICI<br />

S.R.L.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY


EN<br />

474 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ASCARD TABLETS 75MG ATCO LABORATORIES<br />

(PVT) LTD<br />

ASCARD TABLETS 300MG ATCO LABORATORIES<br />

(PVT) LTD<br />

ASCARD TABLETS 150MG ATCO LABORATORIES<br />

(PVT) LTD<br />

PAKISTAN<br />

PAKISTAN<br />

PAKISTAN<br />

ASCORBIC ACID 100MG TABLETS 100MG PHARMAMED LTD. MALTA<br />

ASCORBIC ACID 250MG TABLETS 250MG PHARMAMED LTD. MALTA<br />

ASCORBIC ACID 500MG CHEWABLE TABLETS 500MG PHARMAMED LTD. MALTA<br />

ASCORBIC ACID BP 100MG TABLET 100MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

ASCORBIC ACID BP 200MG TABLET 200MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

ASCORBIC ACID BP 500MG TABLET 500MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

ASCORBIC ACID BP 50MG TABLET 50MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

ASCORBIC ACID INJECTION<br />

AMPOULE<br />

SOLUTION FOR<br />

INJECTION<br />

ASCORBIC ACID INJECTION BPC SOLUTION FOR<br />

INJECTION<br />

500MG/5ML F.H. FAULDING & CO LTD<br />

(T/A DAVID BULL LABS)<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

500MG/5ML EVANS MEDICAL LIMITED UNITED KINGDOM<br />

ASCOSAL EFFERVESCENT TABLETS N/A DR. GROSSMAN AG<br />

PHARMACA<br />

ASCRIPTIN TABLET N/A RORER<br />

PHARMACEUTICALS LTD.<br />

(T/A RHONE POULENC<br />

RORER)<br />

ASERBINE TOPICAL SOLUTION NA FORLEY LIMITED T/A<br />

FORLEY<br />

PHARMACEUTICALS<br />

ASERBINE CREAM NA FORLEY LIMITED T/A<br />

FORLEY<br />

PHARMACEUTICALS<br />

ASILONE ANTACID LIQUID ORAL SUSPENSION N/A SETON PRODUCTS<br />

LIMITED<br />

ASILONE ANTACID TABLETS TABLETS N/A SETON PRODUCTS<br />

LIMITED<br />

ASILONE HEARTBURN LIQUID ORAL SUSPENSION N/A SETON PRODUCTS<br />

LIMITED<br />

ASILONE HEARTBURN TABLETS TABLETS N/A SETON PRODUCTS<br />

LIMITED<br />

ASMABEC INHALATION POWDER 50MCG/AC MEDEVA PHARMA<br />

LIMITED<br />

ASMABEC CLICKHALER INHALATION POWDER 250MCG/AC MEDEVA PHARMA<br />

LIMITED<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 475<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ASMABEC CLICKHALER 100 INHALATION POWDER 100MCG/AC MEDEVA PHARMA<br />

LIMITED<br />

ASMASAL CLICKHALER INHALATION POWDER 95MCG/AC MEDEVA PHARMA<br />

LIMITED<br />

ASMOVAL TABLETS 10MG REMEDICA LTD CYPRUS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ASPARAGINASE 10000 MEDAC POWDER FOR INJECTION 10000IU MEDAC GMBH GERMANY<br />

ASPEGIC 500MG POWDER FOR ORAL SOL. 500MG/SACHET LABORATOIRES<br />

SYNTHELABO<br />

ASPEGIC FOR INJECTION<br />

500MG/5ML<br />

POWDER FOR<br />

INJECTABLE SOL<br />

500MG/5ML LABORATOIRES<br />

SYNTHELABO<br />

FRANCE<br />

FRANCE<br />

ASPIREM 125 SUPPOSITORIES 125MG REMEDICA LTD CYPRUS<br />

ASPIREM 150 E.C. TABLETS 150MG REMEDICA LTD CYPRUS<br />

ASPIREM 300 E.C. TABLETS 300MG REMEDICA LTD CYPRUS<br />

ASPIREM 75 E.C. TABLETS 75MG REMEDICA LTD CYPRUS<br />

ASPIRIN ENTERIC COATED<br />

TABLET<br />

75MG THE WALLIS<br />

LABORATORY LIMITED<br />

ASPIRIN TABLETS 75MG PHARMAMED LTD. MALTA<br />

ASPIRIN TABLETS 75MG PHARMAMED LTD. MALTA<br />

ASPIRIN TABLETS 300MG M & A PHARMACHEM<br />

LIMITED<br />

ASPIRIN BP 300MG TABLET 300MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

ASPIRIN BP 75MG TABLET 75MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

ASPIRIN PLUS C EFFERVESCENT TABLET N/A BAYER VITAL GMBH &<br />

CO. KG<br />

ASPIRIN PROTECT 100 ENTERIC COATED<br />

TABLET<br />

ASPIRIN PROTECT 300 ENTERIC COATED<br />

TABLET<br />

ASPIRIN TABLETS 75MG EC GASTRO-RESISTANT<br />

TABS<br />

100MG BAYER VITAL GMBH &<br />

CO. KG<br />

300MG BAYER VITAL GMBH &<br />

CO. KG<br />

75MG THE WALLIS<br />

LABORATORY LIMITED<br />

ASPIRIN TABLETS DISPERSIBLE BP DISPERSIBLE TABLETS 75MG CP PHARMACEUTICALS<br />

LTD.<br />

ASPRO 320MG TABLET 320MG LABORATOIRES ROCHE<br />

NICHOLAS S.A.<br />

ASPRO 500MG EFFERVESCENT TABLET 500MG LABORATOIRES ROCHE<br />

NICHOLAS S.A.<br />

ASTHALIN 4 TABLET TABLET 4MG CIPLA LTD. INDIA<br />

ASTHALIN INHALER INHALATION AEROSOL 100MCG/DOSE CIPLA LIMITED INDIA<br />

ASTHALIN RESPIRATOR<br />

SOLUTION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

RESPIRATOR SOLUTION 5MG/1ML CIPLA LIMITED INDIA<br />

ASTHALIN SYRUP SYRUP N/A CIPLA LTD INDIA


EN<br />

476 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ASTIZOL TABLETS 10MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

ASTRIX 100 CAPSULE 100MG FAULDING<br />

PHARMACEUTICALS<br />

JORDAN<br />

AUSTRALIA<br />

ASYRAN TABLETS 150MG DELTA HF ICELAND<br />

ASYRAN TABLETS 300MG DELTA HF ICELAND<br />

ATACAND TABLET 16MG ASTRA<br />

PHARMACEUTICALS<br />

LIMITED<br />

ATACAND 8MG TABLET 8MG ASTRA<br />

PHARMACEUTICALS LTD<br />

SWEDEN<br />

SWEDEN<br />

ATALINE 2.5MG TABLET 2.5MG MEDOCHEMIE LTD CYPRUS<br />

ATARAX FILM-COATED TABLET 25MG U.C.B. S.A. BELGIUM<br />

ATARAX SYRUP 2MG/ML U.C.B. S.A. BELGIUM<br />

ATARAX TABLET 25MG UNITED CHEMICALS OF<br />

BELGIUM<br />

ATENOLOL TABLETS 50MG NORTON HEALTHCARE<br />

LIMITED<br />

ATENOLOL TABLETS 100MG NORTON HEALTHCARE<br />

LIMITED<br />

PAKISTAN<br />

ATENOLOL TABLETS 100MG PHARMAMED LTD. MALTA<br />

ATENOLOL TABLETS 50MG PHARMAMED LTD. MALTA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ATENOLOL COATED TABLETS 100MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

ATENOLOL DELTA TABLETS 25MG DELTA HF ICELAND<br />

ATENOLOL DELTA TABLETS 50MG DELTA HF ICELAND<br />

ATENOLOL DELTA TABLETS 100MG DELTA HF ICELAND<br />

ATENOLOL DENK 50 FILM-COATED TABLETS 50MG E.DENK OHG GERMANY<br />

ATENSIN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS<br />

ATENSIN 40MG TABLET 40MG MEDOCHEMIE LTD CYPRUS<br />

ATIVAN TABLETS 2.5MG JOHN WYETH &<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

IRELAND<br />

ATIVAN 1MG TABLETS 1MG WYETH-PHARMA GMBH GERMANY<br />

ATIVAN 1MG TABLETS 1MG JOHN WYETH AND<br />

BROTHER LTD T/A<br />

WYETH LABORATORIES<br />

UNITED KINGDOM<br />

ATIVAN 2MG TABLET 2MG WYETH-PHARMA GMBH GERMANY<br />

ATIVAN 2MG TABLETS 2MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

IRELAND<br />

ATODEL TABLETS 1MG REMEDICA LTD. CYPRUS<br />

ATODEL TABLETS 2MG REMEDICA LTD. CYPRUS


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 477<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ATODEL 1 TABLETS 1MG REMEDICA LTD CYPRUS<br />

ATODEL 2 TABLETS 2MG REMEDICA LTD CYPRUS<br />

ATODEL 5 TABLETS 5MG REMEDICA LTD CYPRUS<br />

ATOMASE AQUEOUS NASAL<br />

SPRAY<br />

NASAL SPRAY 50MCG/DOSE DOUGLAS<br />

PHARMACEUTICALS LTD.<br />

NEW ZEALAND<br />

ATROMID-S CAPSULES 500MG ZENECA LIMITED UNITED KINGDOM<br />

ATROPINA 1% FARMIGEA OPHTHALMIC DROPS 5MG FARMIGEA SPA ITALY<br />

ATROPINE SOLUTION FOR<br />

INJECTION<br />

0.5MG/ML PHARMAMED<br />

PARENTERALS LTD.<br />

MALTA<br />

ATROPINE DISPERSA 1% EYE DROPS 1% W/V CIBA VISION AG SWITZERLAND<br />

ATROPINE DISPERSA 1.0% EYE DROPS 10.0MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

ATROPINE INJECTION BP<br />

MINIJECT<br />

SOLUTION FOR<br />

INJECTION<br />

ATROPINE INJECTION BP MINIJET SOLUTION FOR<br />

INJECTION<br />

ATROPINE MINIJET SOLUTION FOR<br />

INJECTION<br />

ATROPINE SULFATE INJECTION<br />

USP<br />

SOLUTION FOR<br />

INJECTION<br />

N/A INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

0.1MG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

0.1MG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

0.1MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

ATROPINE SULPHATE TABLETS 600 MCG CP PHARMACEUTICALS<br />

LIMITED<br />

ATROPINE SULPHATE TABLETS 600MCG CP PHARMACEUTICALS<br />

LTD.<br />

ATROPINE SULPHATE SOLUTION FOR<br />

INJECTION<br />

ATROPINE SULPHATE INJECTION<br />

0.5MG<br />

ATROPINE SULPHATE INJECTION<br />

1MG<br />

ATROPINE SULPHATE INJECTION<br />

BP<br />

ATROPINE SULPHATE INJECTION<br />

BP 600MCG/ML<br />

600MCG/ML ANTIGEN<br />

PHARMACEUTICALS<br />

INJECTION SOLUTION 0.05% W/V B.BRAUN MELSUNGEN<br />

AG<br />

INJECTION SOLUTION 0.1% W/V B.BRAUN MELSUNGEN<br />

AG<br />

SOLUTION FOR<br />

INJECTIONS<br />

SOLUTION FOR<br />

INJECTION<br />

600MCG/1ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

600MCG/ML MACARTHYS<br />

LABORATORIES LIMITED<br />

T/A MARTINDALE<br />

LIMITED<br />

ATROVENT NEBULISER SOLUTION 500MCG/2ML BOEHRINGER INGELHEIM<br />

LTD<br />

ATROVENT N METERED AEROSOL PUFF SOLUTION 20MCG BOEHRINGER INGELHEIM<br />

PHARMA KG —<br />

GERMANY<br />

ATROVENT NASAL PUMP SPRAY<br />

0.03%<br />

NASAL PUMP SPRAY 0.314MG/ML BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

AUDAX EAR DROPS DROPS N/A MUNDIPHARMA<br />

PHARMACEUTICALS LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

GERMANY<br />

GERMANY<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

CYPRUS


EN<br />

478 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

AUGMENTIN TABLET 375MG SMITH KLINE &<br />

BEECHAM<br />

AUGMENTIN TABLET N/A SMITH KLINE &<br />

BEECHAM<br />

PAKISTAN<br />

PAKISTAN<br />

AUGMENTIN 1.2G IV POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AUGMENTIN 156MG SUSPENSION POWDER FOR ORAL<br />

SOLUTION<br />

N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AUGMENTIN 1G COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AUGMENTIN 228MG SUSPENSION POWDER FOR ORAL<br />

SUSPEN.<br />

AUGMENTIN 312MG SUSPENSION POWDER FOR ORAL<br />

SOLUTION<br />

AUGMENTIN 457MG SUSPENSION POWDER FOR ORAL<br />

SUSPEN.<br />

N/A SMITHKLINE BEECHAM<br />

PLC<br />

UNITED KINGDOM<br />

N/A BEECHAM PLC UNITED KINGDOM<br />

N/A SMITHKLINE BEECHAM<br />

PLC<br />

UNITED KINGDOM<br />

AUGMENTIN 600MG IV POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AUGMENTIN 625MG TABLETS COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AUGMENTIN 625MG TABS. TWICE<br />

DAILY DOSING<br />

AUGMENTIN DISPERSIBLE<br />

TABLETS 375MG<br />

COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

TABLET FOR ORAL<br />

SOLUTION<br />

AUGMENTIN INFANT DROPS POWDER FOR ORAL<br />

SOLUTION<br />

N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AUGMENTIN TABLETS 375MG COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

AULIN TABLETS 100MG HELSINN BIREX<br />

PHARMACEUTICALS LTD.<br />

AULIN ORAL POWDER FOR<br />

RECON.<br />

AUNATIV SOLUTION FOR<br />

INJECTION<br />

AUNATIV SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

100MG/SACHET HELSINN BIREX<br />

PHARMACEUTICALS LTD.<br />

250IU/ML PHARMACIA & UPJOHN<br />

AB<br />

IRELAND<br />

IRELAND<br />

SWEDEN<br />

200IU/ML BIOVITRUM SWEDEN<br />

AUREOMYCIN OINTMENT OINTMENT 3% W/W CYANAMID OF GREAT<br />

BRITAIN LTD.<br />

AUREOMYCIN SALBE OINTMENT 3G/100G LEDERLE ARZNEIMITTEL<br />

GMBH & CO<br />

UNITED KINGDOM<br />

GERMANY<br />

AUREOMYCINE MONOT 3% OINTMENT 3% LABORATOIRES MONOT FRANCE<br />

AURIGOUTTE EAR DROPS N/A LABORAOIRES MONOT FRANCE<br />

AVALOX 400MG FILM-COATED TABLET 400MG BAYER VITAL GMBH &<br />

CO. KG<br />

AVANDIA TABLET 2MG SMITHKLINE BEECHAM<br />

CORPORATION<br />

AVANDIA TABLET 4MG SMITHKLINE BEECHAM<br />

CORPORATION<br />

AVANDIA TABLET 8MG SMITHKLINE BEECHAM<br />

CORPORATION<br />

GERMANY<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 479<br />

Trade Name Dosage Form Dose MA Holder Country<br />

AVANDIA FILM-COATED TABLETS 1MG SMITHKLINE BEECHAM<br />

PLC<br />

AVANDIA FILM-COATED TABLETS 2MG SMITHKLINE BEECHAM<br />

PLC<br />

AVANDIA FILM COATED TABLETS 4MG SMITHKLINE BEECHAM<br />

PLC<br />

AVANDIA FILM COATED TABLETS 8MG SMITHKLINE BEECHAM<br />

PLC<br />

AVANT 1.5MG TABLET 1.5MG MEDOCHEMIE LTD CYPRUS<br />

AVANT 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS<br />

AVANT 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

AVAXIM SUSPENSION FOR<br />

INJECTION<br />

160 AU/0.5ML PASTEUR MERIEUX FRANCE<br />

AVELOX FILM-COATED TABLET 400MG BAYER VITAL GMBH &<br />

CO. KG<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

GERMANY<br />

AVERNOL TABLETS 25MG MEDOCHEMIE LTD. CYPRUS<br />

AVIPUR TABLETS 50,000IU TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD.<br />

AVIPUR TABLETS TABLET 50,000 IU TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

ISRAEL<br />

ISRAEL<br />

AVIRAL-200 TABLETS 200MG MEPHA PHARMA AG SWITZERLAND<br />

AVIRAL-400 TABLETS 400MG MEPHA PAHRMA AG SWITZERLAND<br />

AVIRAL-800 TABLETS 800MG MEPHA PHARMA AG SWITZERLAND<br />

AVOCLOR TABLET 250MG ZENECA LIMITED UNITED KINGDOM<br />

AVOMINE TABLETS 25MG MANX PHARMA LIMITED UNITED KINGDOM<br />

AVOMINE TABLET 25MG RHONE-POULENC RORER<br />

PAKISTAN (PVT) LIMITED<br />

AVONEX POWDER + SOLVENT<br />

FOR INJ.<br />

AVONEX POWDER AND SOLVENT<br />

FOR INJ<br />

PAKISTAN<br />

30UG/ML BIOGEN FRANCE S.A. FRANCE<br />

30MCG BIOGEN FRANCE S.A. EUROPEAN COMMUNITY<br />

AXETINE 250MG POWDER FOR INJECTION 250MG MEDOCHEMIE LTD CYPRUS<br />

AXETINE 750MG POWDER FOR INJECTION 750MG MEDOCHEMIE LTD CYPRUS<br />

AXSAIN CREAM 0.075% W / W BIOGLAN<br />

LABORATORIES LTD<br />

AXURA FILM-COATED TABLETS 10MG MERZ<br />

PHARMACEUTICALS<br />

GMBH<br />

AXURA ORAL DROPS SOLUTION 10MG/G MERZ<br />

PHARMACEUTICALS<br />

GMBH<br />

AZACTAM POWDER FOR INJECTION 500MG BRISTOL-MYERS SQUIBB<br />

S.P.A<br />

UNITED KINGDOM<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

ITALY


EN<br />

480 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

AZACTAM POWDER FOR INJECTION 1G BRISTOL-MYERS SQUIBB<br />

S.P.A<br />

AZACTAM POWDER FOR INJECTION 1G E R SQUIBB & SONS<br />

LIMITED<br />

AZACTAM POWDER FOR INJECTION 2GM ER SQUIBB & SONS<br />

LIMITED<br />

AZAMUN FILM COATED TABLET 50MG DOUGLAS<br />

PHARMACEUTICALS LTD<br />

ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NEW ZEALAND<br />

AZANTAC 150MG EFFERVESCENT TABLET 150MG GLAXO WELLCOME FRANCE<br />

AZANTAC 300MG EFFEVESCENT TABLET 300MG GLAXO WELLCOME FRANCE<br />

AZATHIOPRINE BP FILM COATED TABLETS 50MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

AZATHIOPRINE PCH TABLET 50MG PHARMACHEMIE BV NETHERLANDS<br />

AZATHIOPRINE TABLETS 50MG TABLETS 50MG NORTON HEALTHCARE<br />

LIMITED<br />

AZATHIOPRINE TABLETS<br />

BP 50MG<br />

UNITED KINGDOM<br />

FILM COATED TABLETS 50MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

AZATRILEM TABLETS 50MG LEMERY S.A. MEXICO<br />

AZEE, AZITHROMYCIN CAPSULES<br />

USP<br />

CAPSULES 250 MG CIPLA LTD. INDIA<br />

AZELDERM CREAM 20%W/W KLEVA LIMITED GREECE<br />

AZEPTIL 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS<br />

AZEPTIL 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS<br />

AZEPTIL 500MG/5ML LIQUID FOR INJECTION 500MG/5ML MEDOCHEMIE LTD CYPRUS<br />

AZITHROMYCIN CAPSULE 250MG PFIZER LIMITED UNITED KINGDOM<br />

AZOPT OPHTHALMIC<br />

SUSPENSION<br />

10MG/ML ALCON LABORATORIES<br />

INC.<br />

AZOPT EYE DROPS SOLUTION 10MG/ML ALCON LABORATORIES<br />

UK LIMITED<br />

BABY MELTUS FOR BABIES<br />

COUGHS<br />

UNITED STATES OF<br />

AMERICA<br />

EUROPEAN COMMUNITY<br />

ORAL SOLUTION 0.42 ML CUPAL LIMITED UNITED KINGDOM<br />

BACLOFEN TABLETS 10MG TABLET 10MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

BACLOFEN TABLETS 10MG TABLET 10MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

BACLOFEN TABLETS 10MG TABLETS 10MG NORTON HEALTHCARE<br />

LIMITED<br />

BACLON 10MG TABLET 10MG LEIRAS OY FINLAND<br />

UNITED KINGDOM<br />

BACTROBAN OINTMENT 2% W/W BEECHAM GROUP PLC UNITED KINGDOM<br />

BACTROBAN CREAM 2% W/W SMITHKLINE BEECHAM<br />

PHARMACEUTICALS<br />

UNITED STATES OF<br />

AMERICA<br />

BACTROBAN CREAM CREAM 2% W/W BEECHAM GROUP PLC UNITED KINGDOM<br />

BACTROBAN NASAL OINTMENT<br />

2% W/W<br />

BALANCED SALT SOLUTION<br />

(AKORN)<br />

NASAL OINTMENT 2% W/W BEECHAM GROUP PLC UNITED KINGDOM<br />

IRRIGATING SOLUTION N/A TAYLOR<br />

PHARMACEUTICALS<br />

UNITED STATES OF<br />

AMERICA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 481<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BALKIS 0.05% NASAL DROPS SOLUTION 0.05% W/V DOLORGIET GMBH & CO.<br />

KG<br />

BALKIS 0.1% NASAL DROPS SOLUTION 0.1% W/V DOLORGIET GMBH & CO.<br />

KG<br />

BALKIS NASAL SPRAY SOLUTION 1MG/ML DOLORGIET GMBH & CO.<br />

KG<br />

BALKIS NASAL SPRAY SOLUTION NASAL SPRAY 1MG/ML DOLORGIET GMBH & CO<br />

KG<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

BALMOSA CREAM N/A PHARMAX LIMITED UNITED KINGDOM<br />

BALTO FOOT BALM OINTMENT N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

BARILUX HD POWDER 96.805% W/W GOLDHAM PHARMA<br />

GMBH<br />

BAYCUTEN N CREAM N/A BAYER VITAL GMBH &<br />

CO. AG<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

BAYCUTEN N CREAM N/A BAYER PAKISTAN<br />

BAYCUTEN-N CREAM N/A BAYER PAKISTAN<br />

BAYRO GEL GEL NA TROPON GMBH GERMANY<br />

BAYROGEL GEL 50MG/G BAYER VITAL GMBH &<br />

CO. KG<br />

BAZUKA EXTRA STRENGTH GEL GEL 26% W/W DIOMED DEVELOPMENTS<br />

LIMITED T/A DERMAL<br />

LABORATORIES<br />

BAZUKA GEL GEL N/A DIOMED DEVELOPMENTS<br />

LIMITED T/A DERMAL<br />

LABORATORIES<br />

BCG VACCINE INTRADERMAL BP FREEZE DIRED PREP. F/<br />

INJ.<br />

BCG VACCINE INTRADERMAL BP<br />

ISONIAZID RES<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

BCG VACCINE PERCUTANEOUS BP FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

BCG VACCINE SSI POWDER FOR INJECTION 0.75MG/ML STATENS SERUM<br />

INSTITUT<br />

DENMARK<br />

BEBEGEL RECTAL GEL N/A ASTA MEDICA FRANCE<br />

BECADRIL 500 CASULES 500MG REMEDICA LTD CYPRUS<br />

BECEDRIL 1G TABLETS 1G REMEDICA LTD CYPRUS<br />

BECEVIT S.C. TABLETS N/A REMEDICA LTD CYPRUS<br />

BECEVIT TABLETS NA REMEDICA LTD. CYPRUS<br />

BECLATE 250 INHALER INHALER 250MCG/<br />

ACTUATION<br />

CIPLA LIMITED INDIA<br />

BECLATE-50 INHALER 50MCG CIPLA LIMITED INDIA<br />

BECLAZONE 100 INHALER 100MCG/DOSE NORTON HEALTHCARE<br />

LIMITED<br />

BECLAZONE 100 CFC-FREE INHALER 100MCG/DOSE NORTON (WATERFORD) IRELAND<br />

UNITED KINGDOM


EN<br />

482 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BECLAZONE 250 INHALER 250MCG/DOSE NORTON HEALTHCARE<br />

LIMITED<br />

BECLAZONE 250 CFC-FREE<br />

INHALER<br />

INHALER 250MCG/DOSE NORTON (WATERFORD) IRELAND<br />

BECLAZONE 50 INHALER 50MCG/DOSE NORTON HEALTHCARE<br />

LIMITED<br />

BECLAZONE 50 CFC-FREE<br />

INHALER<br />

BECLAZONE 50 EASI-BREATHE<br />

CFC-FREE<br />

BECLAZONE EASI-BREATHE<br />

CFC-FREE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

INHALER 50MCG/DOSE NORTON (WATERFORD) UNITED KINGDOM<br />

INHALER 50MCG/DOSE NORTON (WATERFORD) IRELAND<br />

INHALER 250MCG/DOSE NORTON (WATERFORD) IRELAND<br />

BECLOFORTE METERED AEROSOL N/A GLAXOWELLCOME PAKISTAN<br />

BECLOFORTE INHALER AEROSOL 250 MCG/AC GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

BECLOFORTE INHALER AEROSOL 250MCG/DOSE GLAXO WELLCOME UK<br />

LIMITED<br />

BECLOMETASONE DIPROPIONATE<br />

50MCG<br />

BECLOMETHASONE<br />

DIPROPIONATE<br />

BECLOMETHASONE<br />

DIPROPIONATE AQ. NASAL SP<br />

BECLOMIST NASAL SPRAY FOR<br />

HAYFEVER<br />

AQUEOUS NASAL SPRAY 0.039%W/V ASHBOURNE<br />

PHARMACEUTICAL<br />

(HOLDINGS) LIMITED<br />

AQUEOUS NASAL SPRAY 50MCG/DOSE NORTON HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NASAL SPRAY 50MCG/ACTUATION GENERICS (UK) LIMITED UNITED KINGDOM<br />

NASAL SPRAY 50MCG/ACTUATION PARKFIELDS<br />

PHARMACEUTICALS<br />

LIMITED<br />

BECONASE ALLERGY NASAL SPRAY 50MCG/AC GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANDURYS<br />

BECONASE AQUEOUS NASAL<br />

SPRAY<br />

BECONASE AQUEOUS NASAL<br />

SPRAY<br />

BECONASE AQUEOUS NASAL<br />

SPRAY<br />

NASAL SPRAY 50MCG/AC GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

NASAL SPRAY 50UG/AC GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN &<br />

HANDBURYS<br />

NASAL SPRAY<br />

SUSPENSION<br />

50MCG/DOSE ALLEN FARMACEUTICA<br />

S.A.<br />

BECONASE HAYFEVER NASAL SPRAY 50MCG/AC GLAXO WELLCOME UK<br />

LIMITED<br />

BECONASE HAYFEVER NASAL SPRAY 50UG/AC GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN &<br />

HANDBURYS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SPAIN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

BECOTIDE AEROSOL F/INH. 50MCG/DOSE GLAXOWELLCOME PAKISTAN<br />

BECOTIDE 100 INHALER AEROSOL 100MCG/AC GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

BECOTIDE 100 INHALER AEROSOL 100UG/AC GLAXO WELLCOME UK<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 483<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BECOTIDE 50 INHALER AEROSOL 50MCG/AC GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

BECOTIDE 50 INHALER AEROSOL 50MCG/DOSE GLAXO WELLCOME UK<br />

LIMITED<br />

BECOZYM FORTE SUGAR-COATED TABLET N/A ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

BEECHAM 75MG ASPIRIN<br />

TABLETS<br />

TABLET 75MG BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

BEECHAM DAY NURSE ORAL SOLUTION N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

BEECHAMS ALL-IN-ONE ORAL SOLUTION N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

BEECHAMS COLD AND FLU HOT<br />

BLACKCURRANT<br />

BEECHAMS COLD AND FLU HOT<br />

LEMON<br />

BEECHAMS COLD AND FLU HOT<br />

LEMON AND HONEY<br />

BEECHAMS FLU-PLUS HOT<br />

LEMON<br />

POWDER FOR ORAL<br />

SOLUTION<br />

POWDER FOR ORAL<br />

SOLUTION<br />

POWDER FOR ORAL<br />

SOLUTION<br />

POWDER FOR ORAL<br />

SOLUTION<br />

BEECHAMS POWDER POWDER FOR ORAL<br />

SOLUTION<br />

BEECHAMS THROAT-PLUS<br />

BLACKCURRANT<br />

N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NA BEECHAM GROUP PLC UNITED KINGDOM<br />

NA BEECHAM GROUP PLC<br />

T/A GLAXOSMITHKLINE<br />

CONSUMER<br />

HEALTHCARE<br />

LOZENGES NA BEECHAM GROUP PLC<br />

T/A GLAXOSMITHKLINE<br />

CONSUMER<br />

HEALTHCARE<br />

BEECHAMS THROAT-PLUS LEMON LOZENGES NA BEECHAM GROUP PLC<br />

T/A GLAXOSMITHKLINE<br />

CONSUMER<br />

HEALTHCARE<br />

BEECHAM'S VENO'S COUGH<br />

MIXTURE<br />

BEECHAMS VENO'S<br />

EXPECTORANT<br />

BEECHAMS VENO'S HONEY AND<br />

LEMON<br />

ORAL SOLUTION N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

ORAL SOLUTION N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

ORAL SOLUTION N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

484 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

BEECHAMS WARMERS<br />

BLACKCURRANT<br />

Trade Name Dosage Form Dose MA Holder Country<br />

POWDER FOR ORAL<br />

SOLUTION<br />

BEECHAMS WARMERS LEMON POWDER FOR ORAL<br />

SOLUTION<br />

BEECHAMS WARMERS LEMON<br />

AND HONEY<br />

POWDER FOR ORAL<br />

SOLUTION<br />

N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

BEGROCIT EFFERVESCENT TABLET N/A DR.GROSSMANN AG<br />

PHARMACA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

BELARAMINE EXPECTORANT SYRUP N/A REMEDICA LTD CYPRUS<br />

BELL'S CHILDRENS COUGH SYRUP ORAL LIQUID 100MG/5ML BELL SONS & CO<br />

(DRUGGISTS) LIMITED<br />

BELL'S WINTERGREEN OINTMENT OINTMENT N/A BELL SONS & CO<br />

(DRUGGISTS) LIMITED<br />

BENADRYL ALLERGY RELIEF CAPSULE 8MG WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

BENDROFLUAZIDE TABLET 5MG CAMDEN INDUSTRIES (M)<br />

SDN.BHD<br />

BENDROFLUAZIDE BP 5MG TABLET 5MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

BENDROFLUAZIDE TABLETS<br />

BP 5MG<br />

BENOXYL 5 LOTION / PANOXYL 5<br />

LOTION<br />

TABLET 5MG CP PHARMACEUTICALS<br />

LTD<br />

TOPICAL EMULSION 5% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

BENT 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

BENXHEXOL 2 TABLETS TABLETS 2MG REMEDICA LTD CYPRUS<br />

BENYLIN CHESTY COUGHS<br />

(NON-DROWSY)<br />

BENYLIN CHESTY COUGHS<br />

(ORIGINAL)<br />

BENYLIN CHILDREN'S CHESTY<br />

COUGHS<br />

BENYLIN CHILDREN'S NIGHT<br />

COUGHS<br />

BENYLIN CHILDREN'S NIGHT<br />

COUGHS<br />

BENYLIN DRY COUGHS (NON<br />

DROWSY)<br />

SYRUP N/A WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

SYRUP N/A WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

SYRUP 50MG/5ML WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

SYRUP N/A WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

SYRUP N/A PFIZER CONSUMER<br />

HEALTHCARE<br />

SYRUP 7.5MG/5ML WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 485<br />

BENYLIN DRY COUGHS<br />

(ORIGINAL)<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SYRUP N/A WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

BENYLIN FOUR FLU LIQUID ORAL SOLUTION N/A WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

BENYLIN FOUR FLU LIQUID ORAL SOLUTION N/A PFIZER CONSUMER<br />

HEALTHCARE<br />

BENYLIN WITH CODEINE SYRUP N/A WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

BENZAMYCIN GEL GEL N/A DERMIK LABORATORIES<br />

INC.<br />

BENZET LOZENGES NA ADCOCK INGRAM<br />

LIMITED<br />

BENZHEXOL BP TABLET 2MG BIOREX LABORATORIES<br />

LTD.<br />

BENZOIN TINCTURE BP TOPICAL<br />

SOLUTION<br />

BENZYL BENZOATE APPLICATION<br />

BP<br />

BENZYL BENZOATE APPLICATION<br />

BP<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SOUTH AFRICA<br />

UNITED KINGDOM<br />

TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM<br />

TOPICAL EMULSION 25% W/V BELL SONS & CO<br />

(DRUGGISTS) LTD<br />

UNITED KINGDOM<br />

TOPICAL EMULSION N/A THORNTON & ROSS UNITED KINGDOM<br />

BEPANTHEN CREAM 50MG/G ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

BEPANTHEN LOTION 25MG/ML ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

SWITZERLAND<br />

SWITZERLAND<br />

BEPANTHEN ROCHE CREAM CREAM 50MG/G HOFFMAN-LA ROCHE AG GERMANY<br />

BEPANTHEN ROCHE OINTMENT OINTMENT 50MG/G HOFFMAN-LA ROCHE AG GERMANY<br />

BEPROGEL TOPICAL SOLUTION 0.5MG/ML HOE PHARMACEUTICALS<br />

SDN BHD<br />

BEPROGEL TOPICAL SOLUTION N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

BEPROSONE CREAM 0.064% W/W HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

BERIATE P 1000. DRY SUBSTANCE AND<br />

SOLVENT<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

N/A AVENTIS BEHRING GMBH GERMANY<br />

BERMOXEL 600MG TABLET 600MG MEDOCHEMIE LTD CYPRUS<br />

BEROCIL 4MG TABLET 4MG MEDOCHEMIE LTD CYPRUS<br />

BEROTEC METERED AEROSOL 100MCG / PUFF BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

BETABIOPTAL EYE DROPS N/A FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

BETACORTEN SCALP APPLICATION 0.1%W/W TRIMA ISRAEL<br />

PHARMACEUTICAL<br />

PRODUCTS LIMITED<br />

BETADERM CRM 0.1%W/W CREAM 0.1% W/W TARO<br />

PHARMACEUTICALS INC<br />

GERMANY<br />

ITALY<br />

ISRAEL<br />

CANADA


EN<br />

486 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BETADERM ONT 0.1% W/W OINTMENT 0.1% W/W TARO<br />

PHARMACEUTICALS INC<br />

BETADINE ALCOHOLIC<br />

SOLUTION 10%<br />

BETADINE ALCOHOLIC<br />

SOLUTION 1O%<br />

SOLUTION 10% MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

TOPICAL ALCOHOLIC<br />

SOLUT.<br />

10% W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD.<br />

BETADINE ANTISEPTIC PAINT 10% ANTISEPTIC PAINT 10%W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

BETADINE ANTISEPTIC SOLUTION SOLUTION 10% MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

BETADINE ANTISEPTIC SOLUTION<br />

10%<br />

ANTISEPTIC SOLUTION 10%W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

BETADINE CREAM CREAM 5%W/W MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

BETADINE CREAM CREAM 5%W/W MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

BETADINE DRY POWDER SPRAY<br />

2.5%<br />

BETADINE GARGLE AND<br />

MOUTHWASH<br />

BETADINE GARGLE AND<br />

MOUTHWASH 1%<br />

POWDER 2.5% W/W MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

GARGLE 1%W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

GARGLE 1%W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD.<br />

BETADINE OINTMENT 10% OINTMENT 10%W/W MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

BETADINE OINTMENT 10% OINTMENT 10%W/W MUNDIPHARMA<br />

PHARMACEUTICALS LTD.<br />

BETADINE SCALP ANDSKIN<br />

CLEANSER 7.5%<br />

TOPICAL LIQUID SOAP 7.5%W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD.<br />

BETADINE SHAMPOO 4% SHAMPOO 4%W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD.<br />

BETADINE SKIN CLEANSER 4% TOPICAL LIQUID SOAP 4%W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

BETADINE SURGICAL SCRUB 7.5% TOPICAL LIQUID SOAP 7.5%W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

BETADINE VAGINAL DOUCHE<br />

10%<br />

BETADINE VAGINAL DOUCHE<br />

10%<br />

BETAFERON POWDER FOR SOLN. FOR<br />

INJ.<br />

BETAFERON POWDER AND SOLVENT<br />

F/SOLUTION F/INJECTION<br />

BETAGAN (LEVOBUNOLOL HCL)<br />

LIQUIFILM<br />

BETAHISTINE DIHYDROCHLORIDE<br />

TABLETS 8MG<br />

DOUCHE 10%W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

DOUCHE 10%W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

TOPICAL OPHTHALMIC<br />

SOLN.<br />

BETAKSIM STERILE POWDER FOR<br />

INJ.<br />

0.25MG/ML SCHERING<br />

AKTIENGESELLSCHAFT<br />

0.25MG/ML SCHERING<br />

AKTIENGESELLSCHAFT<br />

0.5% W/V ALLERGAN<br />

PHARMACEUTICALS<br />

(IRELAND) LTD., INC.<br />

CANADA<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

CYPRUS<br />

UNITED KINGDOM<br />

EUROPEAN COMMUNITY<br />

IRELAND<br />

TABLET 8MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

1G MUSTAFA NEVZAT ILAC<br />

SANAYII A.S.<br />

TURKEY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 487<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BETAMESOL CREAM 0.05% W/W PROGE FARM S.R.L. ITALY<br />

BETAMESOL TUBO 30G CREMA<br />

0.05%<br />

BETAMETHASONE CREAM<br />

0.1%W/W<br />

CREAM N/A PROGE FARM S.R.L ITALY<br />

CREAM 0.1% W/W SM PHARMACEUTICALS<br />

SDN.BHD.<br />

BETAPLEX TABLET N/A CAMDEN INDUSTRIES (M)<br />

SDN. BHD.<br />

MALAYSIA<br />

MALAYSIA<br />

BETAPYN TABLET N/A ADCOCK INGRAM LTD SOUTH AFRICA<br />

BETASERC TABLET 8MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

BETASERC TABLET 16MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

NETHERLANDS<br />

NETHERLANDS<br />

BETASONE CREAM CREAM 0.1% W/W HOVID SDN. BHD. MALAYSIA<br />

BETAVIX SYRUP SYRUP 7.5MG/5ML GENEPHARM S.A. GREECE<br />

BETNESOL 0.50MG EFFERVESCENT TABLET 0.5MG GLAXO WELLCOME FRANCE<br />

BETNOVATE CREAM 1MG/G GLAXO WELLCOME PAKISTAN<br />

BETNOVATE OINTMENT 1MG/G GLAXO WELLCOME PAKISTAN<br />

BETNOVATE C CREAM CREAM N/A GLAXO WELLCOME UK<br />

LTD T/A GLAXO LABS<br />

BETNOVATE C CREAM CREAM NA GLAXO WELLCOME UK<br />

LIMITED<br />

BETNOVATE CREAM CREAM 0.122% W/W GLAXO WELLCOME UK<br />

LTD<br />

BETNOVATE CREAM CREAM 0.122%W/W GLAXO WELLCOME UK<br />

LIMITED<br />

BETNOVATE N CREAM CREAM N/A GLAXO WELLCOME UK<br />

LTD T/A GLAXO LABS<br />

BETNOVATE N CREAM CREAM NA GLAXO WELLCOME UK<br />

LIMITED<br />

BETNOVATE OINTMENT OINTMENT 0.122% W/W GLAXO WELLCOME LTD<br />

T/A GLAXO LABS<br />

BETNOVATE OINTMENT OINTMENT 0.1% W/W GLAXO WELLCOME UK<br />

LIMITED<br />

BETNOVATE SCALP TOPICAL SOLUTION 0.1%W/W GLAXO WELLCOME UK<br />

LIMITED<br />

BETNOVATE SCALP APPLICATION TOPICAL SOLUTION 0.122% W/W GLAXO WELLCOME UK<br />

LTD<br />

BETNOVATE SCALP APPLICATION SOLUTION FOR TOPICAL<br />

USE<br />

0.122%W/W GLAXO WELLCOME UK<br />

LIMITED<br />

BETNOVATE SCALP APPLICATION TOPICAL SOLUTION 0.1%W/W GLAXO LABORATORIES<br />

LIMITED<br />

BETOPTIC S/BETOPTIC<br />

SUSPENSION<br />

OPHTHALMIC<br />

SUSPENSION<br />

2.5MG/ML S.A. ALCON-COUVREUR<br />

N.V.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

UNITED KINGDOM<br />

BELGIUM<br />

BETRISS TABLET N/A MEDOCHEMIE LTD CYPRUS


EN<br />

488 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BETTAMOUSSE CUTANEOUS FOAM 0.12%W/W MEDEVA PHARMA<br />

LIMITED<br />

BEZALIP FILM COATED TABLET 200MG HOFFMANN-LA ROCHE<br />

AG<br />

BEZALIP RETARD COATED SUSTAINED<br />

REL. TAB<br />

UNITED KINGDOM<br />

GERMANY<br />

400MG HOFFMANN-LA ROCHE GERMANY<br />

BI PRETERAX TABLET N/A LES LABORATOIRES<br />

SERVIER<br />

BIAFINE EMLSION F/CUTANEOUS<br />

APPL.<br />

FRANCE<br />

0.67G/100G LABORATOIRES MEDIX FRANCE<br />

BIO 3 CAMOMILE TEA INFUSION BAG 1.5G BIODES, S.L. SPAIN<br />

BIO 3 HERBAL TEA INFUSION BAG 1.5G BIODES, S.L. SPAIN<br />

BIO 3 OBESIDAD-OBESITY CAPSULES 500MG BIODES, S.L. SPAIN<br />

BIO 3 POWDER FOR ORAL<br />

RECONSTITUTION<br />

POWDER N/A BIODES S.L. SPAIN<br />

BIO 3 WEIGHT CONTROL INFUSION BAG N/A BIODES, S.L. SPAIN<br />

BIOCADMIO SUSPENSION CUTANEOUS<br />

SUSPENSION<br />

BIOCALYPTOL WITH<br />

PHOLCODINE<br />

1G/100ML J.URIACH & CIA. S.A. SPAIN<br />

SYRUP N/A LABORATORIES LAPHAL FRANCE<br />

BIOCARBON TABLETS NA F.TRENKA CHEMISCH-<br />

PHARMAZEUTISCHE<br />

FABRIK GMBH<br />

BIOCINE TEST PPD INTRADER. MULTIPUNC.<br />

TEST<br />

AUSTRIA<br />

N/A CHIRON S.P.A. ITALY<br />

BIODRAMINA CHEWING-GUM 20MG J.URIACH & CIA. S.A. SPAIN<br />

BIODRAMINA TABLET 50MG J.URIACH & CIA. S.A. SPAIN<br />

BIODRAMINA INFANTILE SUPPOSITORY 50MG J.URIACH & CIA. S.A. SPAIN<br />

BIOELECTRA CALCIUM 500 EFFERVESCENT TABLETS 500MG HERMES ARZNEMEITTEL<br />

GMBH<br />

BIOFERON 1 M.I.U FREEZE DRIED PWR FOR<br />

INJ<br />

BIOFERON 10 M.I.U. FREEZE DRIED PWR FOR<br />

INJ<br />

BIOFERON 3 M.I.U FREEZE DRIED PWD FOR<br />

INJ<br />

BIOFERON 5 M.I.U FREEZE DRIED PWD FOR<br />

INJ<br />

GERMANY<br />

1000000 IU INSTITUTO SIDUS S.A. ARGENTINA<br />

10000000 IU INSTITUTO SIDUS S.A. ARGENTINA<br />

3000000 IU INSTITUTO SIDUS S.A ARGENTINA<br />

5000000 IU INSTITUTO SIDUS S.A ARGENTINA<br />

BIOFLOR CAPSULES 250MG BIOMED AG SWITZERLAND<br />

BIOFLOR POWDER FOR ORAL<br />

SUSP.<br />

250MG/SACHET BIOMED AG SWITZERLAND<br />

BIOLECTRA CALCIUM 500 EFFERVESCENT TABLET 500MG HERMES ARZNEIMITTEL<br />

GMBH<br />

GERMANY<br />

BIOPLUS EFFERVESCENT TABLETS TABLETS N/A ADCOCK INGRAM LTD SOUTH AFRICA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 489<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BIORAL GEL OROMUCOSAL GEL 2% W/W SEVEN SEAS LIMITED T/A<br />

MERCK CONSUMER<br />

HEALTH<br />

BIORINIL NASAL SPRAY,<br />

SUSPENSION<br />

BIOSELENIUM SUSPENSION CUTANEOUS<br />

SUSPENSION<br />

N/A FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

UNITED KINGDOM<br />

ITALY<br />

2.5G/100ML J.URIACH & CIA. S.A. SPAIN<br />

BIO-STAR CAPSULES 80MG LABORATORIOS NOVAG,<br />

S.A.<br />

BIO-STAR VIALS ORAL SOLUTION N/A LABORATORIOS NOVAG,<br />

S.A.<br />

BIOTONE ORAL SOLN IN AMPOULE N/A LABORATORIES LAPHAL FRANCE<br />

BIPROFENID 150MG TABLET 150MG SPECIA LABORATORIES FRANCE<br />

BISACODYL TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

BISACODYL BP 5MG TABLET 5MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

BISACODYL SUPPOSITORIES<br />

BP 10MG<br />

SUPPOSITORY 10MG MARTINDALE<br />

PHARMACEUTICALS LTD<br />

BISACODYL TABLET 5MG TABLET 5MG CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

BISACODYL TABLET B.P. 5MG TABLET 5MG PHARMMALAYSIA<br />

BERHAD<br />

BISACODYL TABLETS 5MG TABLET 5MG GEOFMAN<br />

PHARMACEUTICALS<br />

BISMUTH SUBNITRATE AND<br />

IODOFORM PASTE<br />

BISODOL HEARTBURN RELIEF<br />

TABLETS<br />

BISODOL INDIGESTION RELIEF<br />

TABLETS<br />

IMPREGNATED GAUZE N/A AURUM<br />

PHARMACEUTICALS<br />

LIMITED<br />

TABLETS N/A WHITEHALL<br />

LABORATORIES LTD<br />

TABLETS N/A WHITEHALL<br />

LABORATORIES LTD<br />

BISODOL TABLETS TABLETS N/A WHITEHALL<br />

LABORATORIES LTD<br />

SPAIN<br />

SPAIN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

MALAYSIA<br />

PAKISTAN<br />

BISOLAX 10MG SUPPOSITORY 10MG MEDOCHEMIE LTD CYPRUS<br />

BISOLAX 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

BISOLVON SOLUTION 0.2G/100ML BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

BISOLVON SOLUTION FOR<br />

INJECTION<br />

8MG/4ML BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

BISOLVON SYRUP 0.08G/100ML BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

BISOLVON TABLETS 8MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

BISOLVON TABLETS 8MG BOEHRINGER INGELHEIM PAKISTAN<br />

BI-TILDIEM SR 120MG SR COATED TABLET 120MG LABORATOIRES<br />

SYNTHELABO<br />

FRANCE


EN<br />

490 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BI-TILDIEM SR 90MG SR COATED TABLET 90MG LABORATOIRES<br />

SYNTHELABO<br />

BLEO-KYOWA POWDER FOR INJECTION 15,000IU KYOWA HAKKO (UK)<br />

LTD<br />

BLEOLEM POWDER FOR<br />

INJECTIONS<br />

FRANCE<br />

15.00U/5ML LEMERY, S.A. DE C.V. MEXICO<br />

BLEOLEM POWDER FOR INJECTION 15U/5ML LEMERY S.A. DE C.V. MEXICO<br />

UNITED KINGDOM<br />

BLISTEX RELIEF CREAM CREAM NA DDD LIMITED UNITED KINGDOM<br />

BLISTEZE CREAM CREAM N/A D D D LIMITED UNITED KINGDOM<br />

BLITZ 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS<br />

BLOPRESID 16/12.5MG TABLETS TABLETS NA TAKEDA ITALIA<br />

FARMACEUTICI S.P.A —<br />

ITALY<br />

BLOPRESS TABLET 4MG TAKEDA ITALIA<br />

FARMACEUTICI S.P.A.<br />

BLOPRESS TABLET 8MG TAKEDA ITALIA<br />

FARMACEUTICI S.P.A.<br />

BLOPRESS TABLET 16MG TAKEDA ITALIA<br />

FARMACEUTICI S.P.A.<br />

BONDIL URETHRAL STICK 125MCG VIVUS UK UNITED KINGDOM<br />

BONDIL URETHRAL STICK 250MCG VIVUS UK UNITED KINGDOM<br />

BONDIL URETHRAL STICK 500MCG VIVUS UK UNITED KINGDOM<br />

BONDIL URETHRAL STICK 1000MCG VIVUS UK UNITED KINGDOM<br />

BONEFOS 400MG CAPSULE 400MG LEIRAS OY FINLAND<br />

BONEFOS 60MG/ML CONC. FOR PARENT.<br />

INFUS.<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

60MG/ML LEIRAS OY FINLAND<br />

BONIDON GEL 10MG/G MEPHA PHARMA AG SWITZERLAND<br />

BONJELA GEL N/A RECKITT & COLMAN PAKISTAN<br />

BONJELA OROMUCOSAL GEL N/A LLOYD'S<br />

PHARMACEUTICALS<br />

LIMITED T/A RECKITT &<br />

COLMAN PRODUCT<br />

BOOTS NIROLEX LOZENGES LOZENGE 2.5MG THE BOOTS COMPANY<br />

PLC<br />

BORADRINE EYE DROPS NA BOURNONVILLE<br />

PHARMA<br />

BOROCAINA LOZENGE N/A ALFA WASSERMANN<br />

S.P.A.<br />

BOROCAINA GOLA TABLETS 1.5MG ALFA WASSERMANN<br />

S.P.A.<br />

BOROCAINA GOLA TABLET 1.5MG ALFA WASSERMANN<br />

S.P.A.<br />

BOROCAINA GOLA TABLET 1.5MG ALFA WASSERMANN<br />

S.P.A.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

BELGIUM<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 491<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BOTOX POWDER SOLN<br />

INJECTION<br />

100 UNITS ALLERGAN SALES LTD IRELAND<br />

BOTOX POWDER F/SOLN F/INJ 100UNITS/VIAL ALLERGAN<br />

PHARMACEUTICALS<br />

(IRELAND) LIMITED<br />

BOTULISM ANTIOXIN BEHRING SOL. FOR INFUSION AND<br />

INJEC<br />

N/A CHIRON BEHRING GMBH<br />

&CO<br />

BOZAKTRAL TABLETS 10MG CHRISPA ALFA<br />

FARMAKEYTICI S.A.<br />

BRADOSOL PLUS LOZENGE N/A NOVARTIS COMSUMER<br />

HEALTH UK LIMITED<br />

BRADOSOL SUGAR FREE CHERRY<br />

MENTHOL<br />

BRADOSOL SUGAR FREE<br />

ORIGINAL CITRUS<br />

LOZENGES 0.04% V/W NOVARTIS CONSUMER<br />

HEALTH UK LIMITED<br />

LOZENGE 0.04% V/W NOVARTIS CONSUMER<br />

HEALTH UK LIMITED<br />

BRASIVOL FINE CREAM 38% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

BRASIVOL MEDIUM CREAM 52% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

BRAUNOL 2000 SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

BRETYLATE SOLUTION FOR<br />

INJECTION<br />

100MG/2ML WELLCOME<br />

FOUNDATION LTD.<br />

BRETYLIUM INJ MINIJET AQUEOUS SOLUTION 50MG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

BRETYLIUM TOSYLATE INJECTION<br />

MINIJET<br />

SOLUTION FOR<br />

INJECTION<br />

BRETYLIUM TOSYLATE MINIJET SOLUTION FOR<br />

INJECTION<br />

BREVIBLOC SOLUTION FOR IV<br />

INFUSION<br />

BREVIBLOC INJECTION SOLUTION FOR IV<br />

INFUSION<br />

50MG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LTD<br />

50MG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

250MG/ML BAXTER<br />

PHARMACEUTICL<br />

PRODUCTS<br />

10MG/ML BAXTER<br />

PHARMACEUTICAL<br />

PRODUCTS<br />

BREVOXYL CREAM 4% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

IRELAND<br />

GERMANY<br />

GREECE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

BRICANYL TABLETS 2.5MG DRACO LAKEMEDEL AB SWEDEN<br />

BRICANYL TURBUHALER INHALATION POWDER 0.5MG/DOSE DRACO LAKEMEDEL AB SWEDEN<br />

BRINERDIN SUGAR COATED<br />

TABLETS<br />

N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

BRINERDINA FILM COATED TABLETS NA NOVARTIS FARMA SPA ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

BROMHEXINE 8 TABLETS 8MG REMEDICA LTD CYPRUS<br />

BROMHEXINE SYRUP ORAL SOLUTION 4MG/5ML CAMDEN INDUSTRIES (M)<br />

SDN. BHD.<br />

MALAYSIA


EN<br />

492 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BROMHEXINE SYRUP 4MG/5ML SYRUP 4MG/5ML CAMDEN INDUSTRIES (M)<br />

SDN. BHD<br />

MALAYSIA<br />

BROMHEXIN-RATIOPHARM SAFT SOLUTION 4MG/5ML RATIOPHARM GMBH GERMANY<br />

BROMOCRIPTINE TABLETS 2.5MG NORTON HEALTHCARE<br />

LIMITED<br />

BRONCALENE ADULTS SYRUP N/A LABORATOIRES MARTIN-<br />

JOHNSON & JOHNSON-<br />

MSD<br />

UNITED KINGDOM<br />

FRANCE<br />

BRONCALENE CHILDREN SYRUP 0.01G/100ML LABORATOIRES MARTIN FRANCE<br />

BRONCALENE INFANT SYRUP N/A LABORATOIRES MARTIN FRANCE<br />

BRONCATHIOL 2% CHILDREN<br />

AND INFANTS<br />

BRONCATHIOL ADULT<br />

EXPECTORANT<br />

SYRUP 2% W/V LABORATOIRES MARTIN FRANCE<br />

ORAL SOLUTION 5G/100ML LABORATOIRES MARTIN-<br />

JOHNSON & JOHNSON-<br />

MSD<br />

FRANCE<br />

BRONCHOPED SYRUP N/A ADCOCK INGRAM LTD SOUTH AFRICA<br />

BRONCHOPRONT CAPSULE WITH SUST.<br />

ACTION<br />

75MG HEINRICH MACK NACHF GERMANY<br />

BRONCHOPRONT SYRUP 0.3G/100ML HEINRICH MACK NACHF GERMANY<br />

BRONCHOTUSSINE SYRUP 4MG/5ML ADELCO-<br />

CHROMATOURGIA<br />

ATHINON E.<br />

COLOCOTRONIS BROS<br />

S.A.<br />

GREECE<br />

BRONCHO-VAXOM ADULTS CAPSULE 40MG OM PHARMA SWITZERLAND<br />

BRONCHO-VAXOM CHILDREN CAPSULE 20MG OM PHARMA SWITZERLAND<br />

BRONCOFLUID ORAL SUSPENSION N/A PHARMARECORD S.R.L. ITALY<br />

BRONCOLIN TABLETS 4MG TABLET 4MG GEOFMAN<br />

PHARMACEUTICALS<br />

BRONQUIMUCIL CAPSULE N/A J.URIACH & CIA., S.A. SPAIN<br />

BRONQUIMUCIL SUSPENSION ORAL SUSPENSION N/A J.URIACH & CIA. S.A. SPAIN<br />

PAKISTAN<br />

BROT 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS<br />

BRUFEN TABLET 400MG KNOLL PAKISTAN<br />

BRULIDINE CREAM 0.15% W/W MANX PHARMA LIMITED UNITED KINGDOM<br />

BRUMETIDINA SOLUTION FOR IM<br />

INJECTION<br />

BRUXICAM DERMATOLOGICAL<br />

CREAM<br />

200MG/2ML BRUSCHETTINI SRL ITALY<br />

1% W/W BRUSCHETTINI SRL ITALY<br />

BRUXICAM CAPSULE 20MG BRUSCHETTINI SRL ITALY<br />

BRUXICAM SUPPOSITORY 20MG BRUSCHETTINI SRL ITALY<br />

BSS 15ML/BSS ALCON INTRAOCULAR IRRIG.<br />

SOLN.<br />

BSS PLUS INTRAOCULAR IRRIGAT.<br />

SOLN<br />

N/A S.A. ALCON-COUVREUR<br />

N.V.<br />

NO ACTIVE ING. ALCON LABORATORIES<br />

INC.<br />

BELGIUM<br />

UNITED STATES OF<br />

AMERICA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 493<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BSS PLUS 250ML AND 500ML/BSS<br />

PLUS ALCON<br />

INTRAOCULAR IRRIG.<br />

SOLN.<br />

N/A S.A. ALCON-COUVREUR<br />

N.V.<br />

BUCCALIN BERNA TABLETS N/A SWISS SERUM AND<br />

VACCINE INSTITUTE<br />

BUCCASTEM BUCCAL TABLETS 3MG RECKITT BENCKISER<br />

HEALTHCARE (UK)<br />

LIMITED<br />

BUDECORT RESPULES 0.25MG CIPLA LTD. INDIA<br />

BUDECORT 0.5MG RESPULES 0.5MG/2ML CIPLA LIMITED INDIA<br />

BUDECORT RESPULES 0.5MG/ML RESPIRATOR<br />

SUSPENSION<br />

BELGIUM<br />

1MG/2ML CIPLA LIMITED INDIA<br />

BUDECORT-100 INHALER 100MCG CIPLA LIMITED INDIA<br />

BUDECORT-200 INHALER 200MCG CIPLA LIMITED INDIA<br />

BUDECORT-200 INHALER 200MCG/AC M/S CIPLA LIMITED INDIA<br />

BUDENOFALK CAPSULES 3MG DR. FALK PHARMA<br />

GMBH<br />

BUDESPRAY — 200 INHALER AEROSOL CANISTER 200 MCG M/S MEDISPRAY<br />

LABORATORIES PVT. LTD<br />

— GOA<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

GERMANY<br />

BUMETANIDE TABLETS 5MG REMEDICA LTD. CYPRUS<br />

BUMETANIDE TABLETS 1MG REMEDICA LTD. CYPRUS<br />

BUPIVACAINE ADRENALINE<br />

MERCK<br />

BUPIVACAINE HCL INJECTION,<br />

USP<br />

BUPIVACAINE HCL INJECTION,<br />

USP 0.5%<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

INDIA<br />

100MG/20ML MERCK GENERICS FRANCE<br />

0.25% W/V ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

0.5% W/V ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

BUPIVACAINE MERCK 0.5% SOLUTION FOR INJ. 100MG/20ML MERCK GENERIQUES FRANCE<br />

BURINEX TABLETS 5MG LEO PHARMACEUTICAL<br />

PRODUCTS<br />

BURINEX TABLETS 1MG LEO PHARMACEUTICAL<br />

PRODUCTS<br />

BURINEX SOLUTION FOR<br />

INJECTION<br />

0.5MG/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

BURINEX A TABLETS N/A LEO PHARMACEUTICAL<br />

PRODUCTS<br />

BURINEX K TABLETS N/A LEO PHARMACEUTICAL<br />

PRODUCTS<br />

DENMARK<br />

DENMARK<br />

DENMARK<br />

DENMARK<br />

DENMARK<br />

BURINEX-K TABLETS TABLETS NA LEO PAKISTAN<br />

BURNEZE SPRAY 1% W/W MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

BUSCOPAN SUGAR COATED<br />

TABLETS<br />

10MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

CYPRUS<br />

GERMANY<br />

BUSCOPAN SUGAR COATED TABLET 10MG BOEHRINGER-INGELHEIM PAKISTAN<br />

BUSCOPAN PLUS TABLETS NA BOEHRINGER INGELHEIM PAKISTAN


EN<br />

494 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

BUSCOPAN TABLETS TABLETS 10MG BOEHRINGER INGELHEIM PAKISTAN<br />

BUSPAR TABLETS 10MG BRISTOL MYERS SQUIBB<br />

AUSTRALIA PTY LTD<br />

BUSPAR TABLETS 5MG BRISTOL-MYERS SQUIBB<br />

COMPANY<br />

BUSPAR TABLETS 10MG BRISTOL-MYERS SQUIBB<br />

COMPANY<br />

BUTIRAN SYRUP N/A FARMACEUTICI ECOBI<br />

S.A.S<br />

BY-VERTIN TABLETS 8MG ERGHA HEALTHCARE<br />

LIMITED<br />

C1 ESTERASE INHIBITOR TIM 3 POWDER FOR INJECTION 1000PU/20ML OSTERREICHISCHES<br />

INSTITUT FUR<br />

HAEMODERIVATE<br />

GES.M.B.H.<br />

CA LAC TABLET 300MG RAZA MANUFACTURING<br />

BERHARD<br />

CABASER TABLETS 2MG PHARMACIA ITALIA<br />

S.P.A.<br />

CABASER TABLET 1MG PHARMACIA ITALIA<br />

S.P.A.<br />

CABASER TABLET 4MG PHARMACIA ITALIA S.P.A ITALY<br />

CABASER TABLETS 1MG PHARMACIA ITALIA SPA ITALY<br />

CABASER TABLETS 2MG PHARMACIA ITALIA SPA ITALY<br />

AUSTRALIA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

ITALY<br />

IRELAND<br />

AUSTRIA<br />

MALAYSIA<br />

CAC 1000 EFFERVESCENT TABLET N/A NOVARTIS PAKISTAN<br />

CAC 1000 EFFERVESCENT TABLET NA NOVARTIS PAKISTAN<br />

CA-C 1000 SANDOZ ORANGE EFFERVESCENT TABLETS N/A NOVARTIS CONSUMER<br />

HEALTH SA<br />

ITALY<br />

ITALY<br />

SWITZERLAND<br />

CAFLAM TABLET 50MG NOVARTIS PAKISTAN<br />

CALADRYL LOTION TOPICAL SUSPENSION N/A WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

CALAMINE LOTION B.P. TOPICAL SUSPENSION N/A WILLIAM RANSOM &<br />

SON PLC<br />

CALAMINE LOTION BP TOPICAL SUSPENSION N/A BELL SONS & CO<br />

(DRUGGISTS) LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CALAMINE LOTION BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM<br />

CALAMINE LOTION BP LOTION N/A PINEWOOD LABS T/A<br />

PINEWOOD<br />

HEALTHCARE<br />

IRELAND<br />

CALAMINE LOTION BP TOPICAL SOLUTION N/A LCM UK UNITED KINGDOM<br />

CALC. FLUOR. NEW ERA<br />

BIOCHEMIC NO.1<br />

CALC. PHOS. NEW ERA NO.2<br />

CALC. PHOS.<br />

CALC. SULPH. 6X NEW ERA<br />

BIOCHEMIC NO.3<br />

TISSUE SALT NO1<br />

TABLET<br />

TISSUE SALT TABLETS<br />

NO.2<br />

NA NEW ERA<br />

LABORATORIES LIMITED<br />

NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALTS NO.3 NA NEW ERA<br />

LABORATORIES LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 495<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CALCICARD CR TABLETS 90MG NORTON HEALTHCARE<br />

LIMITED<br />

CALCICARD CR TABLETS 120MG NORTON HEALTHCARE<br />

LIMITED<br />

CALCICHEW 500MG TABLETS TABLET 500MG SHIRE<br />

PHARMACEUTICALS<br />

LIMITED<br />

CALCICHEW D3 FORTE TABLET N/A SHIRE<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CALCIFEROL OIL FOR INJECTION 3Ù5UNITS/1ML EVANS MEDICAL LIMITED UNITED KINGDOM<br />

CALCIFEROL INJECTION BP OIL FOR INJECTION 6(Ù5) UNITS/2ML EVANS MEDICAL LIMITED UNITED KINGDOM<br />

CALCIO 300 TABLET 300MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

CALCIPEN TABLETS 670MG LEO PHARMACEUTICAL<br />

PRODUCTS<br />

CALCITONIN NOVARTIS SOLUTION FOR<br />

INJECTION<br />

100IU NOVARTIS PHARMA<br />

GMBH<br />

CALCIUM — SANDOZ F EFFERVESCENT TABLETS N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

UNITED KINGDOM<br />

DENMARK<br />

AUSTRIA<br />

SWITZERLAND<br />

CALCIUM 500 WITH D TABLETS N/A AEGIS LTD. CYPRUS<br />

CALCIUM CHLORIDE INJECTION<br />

MINIJET<br />

CALCIUM CHLORIDE INJECTION<br />

MINIJET<br />

SOLUTION FOR<br />

INJECTION<br />

CALCIUM GLUCONATE INJECTION SOLUTION FOR<br />

INJECTION<br />

CALCIUM GLUCONATE INJECTION<br />

BP<br />

10%W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

AQUEOUS INJECTION 10% W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

SOLUTION FOR<br />

INJECTION<br />

1G/10ML F.H. FAULDING AND CO.<br />

LTD (T/A DAVID BULL<br />

LABS)<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

89MG/10ML EVANS MEDICAL LIMITED UNITED KINGDOM<br />

CALCIUM LACTATE TABLETS 300MG PHARMAMED LTD. MALTA<br />

CALCIUM LACTATE 300 TABLETS 300MG REMEDICA LTD CYPRUS<br />

CALCIUM LACTATE BP 300MG TABLET 300MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

CALCIUM LEUCOVORIN TABLETS 15MG CYANAMID OF GREAT<br />

BRITAIN LTD. T/A<br />

LEDERLE LABS.<br />

CALCIUM LEUCOVORIN TABLETS 15MG CYANAMID OF GREAT<br />

BRITAIN LTD<br />

CALCIUM RESONIUM ORAL POWDER 99.934%W/W SANOFI WINTHROP<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CALCIUM SANDOZ EFFERVESCENT TABLET N/A SANDOZ PAKISTAN<br />

CALGEL TEETHING GEL GINGIVAL GEL N/A GLAXO WELLCOME UK<br />

LIMITED<br />

UNITED KINGDOM


EN<br />

496 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CALIMAL TABLET 4MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

CALLIMON EFFERVESCENT TABLET N/A DR.GROSSMANN AG<br />

PHARMACA<br />

CALM LIFE COATED TABLETS NA THE HERBAL RESEARCH<br />

COMPANY LIMITED<br />

CALMPOSE 5MG TABLETS TABLETS 5MG RANBAXY<br />

LABORATORIES LTD.<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

CALMURID CREAM N/A GALDERMA (UK) LIMITED UNITED KINGDOM<br />

CALMURID HC CREAM N/A GALDERMA (UK) LIMITED UNITED KINGDOM<br />

CALPOL 6+ SUSPENSION ORAL SUSPENSION 250MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

CALPOL INFANT SUSPENSION ORAL SUSPENSION 120MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

CALPOL SIX-PLUS SUSPENSION ORAL SUSPENSION 250MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

CALPOL SUGAR FREE INFANT<br />

SUSPENSION<br />

CALPOL SUGAR FREE INFANT<br />

SUSPENSION<br />

CALSALETTES (SUGAR COATED)<br />

TABLETS<br />

ORAL SUSPENSION 120MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

ORAL SUSPENSION 120MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

COATED TABLET 38MG TORBET LABORATORIES<br />

LIMITED<br />

INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

UNITED KINGDOM<br />

CAMCOLIT 250 TABLETS 250MG NORGINE LIMITED UNITED KINGDOM<br />

CAMCOLIT 400 TABLETS 400MG NORGINE LIMITED UNITED KINGDOM<br />

CAMCOLIT 400MG TABLET 400MG BIOPHARMA PAKISTAN<br />

CAMNOVATE CREAM CREAM 0.1% W/W CAMDEN INDUSTRIES (M)<br />

SDN.BHD<br />

CAMPTO 100MG/5ML CONCENTRATE FOR<br />

INFUSION<br />

CAMPTO 40MG/2ML CONCENTRATE FOR<br />

INFUSION<br />

MALAYSIA<br />

100MG/5ML MAY & BAKER LIMITED UNITED KINGDOM<br />

20MG/ML MAY & BAKER LIMITED UNITED KINGDOM<br />

CANDACORT CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

CANDACORT CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

CANDACORT CREAM CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD<br />

CANDAZOLE CREAM 1% W/W HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

CANDAZOLE CREAM 1%W/W HOE PHARMACEUTICALS<br />

SDN BHD<br />

CANDAZOLE LOTION 1% W/V HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

CANDAZOLE LOTION LOTION 1% W/V HOE PHARMACEUTICALS<br />

SDN. BHD<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

CANDIPLAS CREAM 2%W/W MEDOCHEMIE LTD CYPRUS


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 497<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CANESTEN CREAM 1G/100G BAYER VITAL GMBH &<br />

CO. KG<br />

GERMANY<br />

CANESTEN VAGINAL TABLET 500MG BAYER PAKISTAN<br />

CANESTEN VAGINAL TABLET 500MG BAYER PAKISTAN<br />

CANESTEN CREAM 0.01G/G BAYER PAKISTAN<br />

CANESTEN CREAM 1% W/W BAYER PAKISTAN<br />

CANESTEN VAGINAL TABLET 100MG BAYER PAKISTAN(PVT)<br />

LTD.<br />

PAKISTAN<br />

CANESTEN 1 10% CREAM VAGINAL CREAM 10%W/W BAYER VITAL GMBH GERMANY<br />

CANESTEN 1% SOLUTION 1G/100ML BAYER VITAL GMBH &<br />

CO. KG<br />

CANESTEN 10% VC (POM) VAGINAL CREAM 10% W/W BAYER PLC T/A<br />

CONSUMER CARE<br />

DIVISION<br />

CANESTEN COMBI VAGINAL CREAM AND<br />

PESSARY<br />

CANESTEN DERMATOLOGICAL<br />

SPRAY<br />

N/A BAYER PLC T/A<br />

CONSUMER CARE<br />

DIVISION<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

TOPICAL SOLUTION 1% W/V BAYER PLC UNITED KINGDOM<br />

CANESTEN HC CREAM 1% CREAM N/A BAYER PLC UNITED KINGDOM<br />

CANESTEN HYDROCORTISONE CREAM N/A BAYER PLC T/A<br />

CONSUMER CARE<br />

DIVISION<br />

UNITED KINGDOM<br />

CANESTEN OASIS EFFERVESCENT POWDER N/A BAYER PLC UNITED KINGDOM<br />

CANESTEN VAGINAL TABLETS VAGINAL TABLETS 100MG BAYER PAKISTAN<br />

CANUSAL SOLUTION FOR<br />

INJECTION<br />

CANUSAL(HEPARIN SODIUM<br />

100U/ML)<br />

SOLUTION FOR<br />

INJECTION<br />

100IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

100IU / ML CP PHARMACEUTICALS<br />

LTD<br />

CAPACE TABLETS 25MG ATCO LABORATORIES<br />

(PVT) LTD<br />

CAPACE TABLETS 12.5MG ATCO LABORATORIES<br />

(PVT) LTD<br />

CAPOCARD TABLETS 50MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

CAPOCARD TABLETS 25MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

PAKISTAN<br />

PAKISTAN<br />

JORDAN<br />

JORDAN<br />

CAPOTEN TABLETS 12.5MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

CAPOTEN TABLETS 25MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

CAPOTEN TABLETS 50MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

CAPOZIDE TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

CAPRIN ENTERIC COATED<br />

TABLETS<br />

75MG SINCLAIR<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM


EN<br />

498 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

CAPTIL TABLET<br />

25MG(CAPTOPRIL)<br />

CAPTIL TABLET 50MG<br />

(CAPTOPRIL)<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TABLET 25MG UNIMED<br />

PHARMACEUTICALS INC.<br />

TABLET 50MG UNIMED<br />

PHARMACEUTICALS INC.<br />

CAPTOPRIL TABLETS 50MG CP PHARMACEUTICALS<br />

LTD.<br />

CAPTOPRIL TABLETS 25MG CP PHARMACEUTICALS<br />

LTD.<br />

CAPTOPRIL TABLETS 12.5MG CP PHARMACEUTICALS<br />

LTD.<br />

CAPTOPRIL TABLETS 12.5MG NORTON HEALTHCARE<br />

LIMITED<br />

CAPTOPRIL TABLETS 25MG NORTON HEALTHCARE<br />

LIMITED<br />

CAPTOPRIL TABLETS 50MG NORTON HEALTHCARE<br />

LIMITED<br />

KOREA REPUBLIC<br />

KOREA REPUBLIC<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CAPTOPRIL DENK 25 TABLETS 25MG E. DENK OHG GERMANY<br />

CAPTOPRIL TABLETS 25MG TABLET 25MG CP PHARMACEUTICALS<br />

LIMITED<br />

CAPTOPRIL TABLETS 50MG TABLET 50MG CP PHARMACEUTICALS<br />

LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CAPTOPRIL TABLETS BP 25MG TABLET 25MG WAYMADE PLC UNITED KINGDOM<br />

CARBACHOL TABLETS 2MG NORTON<br />

PHARMACEUTICALS<br />

LIMITED<br />

CARBAMAZEPINE TABLETS 100MG NORTON HEALTHCARE<br />

LIMITED<br />

CARBAMAZEPINE TABLETS 200MG NORTON HEALTHCARE<br />

LIMITED<br />

CARBAMAZEPINE TABLETS 400MG NORTON HEALTHCARE<br />

LIMITED<br />

CARBATOL TABLETS 200MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

CARBATOL TABLETS 200MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

CARBELLON TABLETS TABLET N/A TORBET LABORATORIES<br />

LIMITED<br />

CARBIMAZOLE TABLET 5MG CAMDEN INDUSTRIES (M)<br />

SDN. BHD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

JORDAN<br />

JORDAN<br />

UNITED KINGDOM<br />

MALAYSIA<br />

CARBIROID TABLET 5MG TABLET 5MG HOVID SDN BHD MALAYSIA<br />

CARBOPLATIN SOLUTION FOR<br />

INJECTION<br />

CARBOPLATIN INJECTION<br />

SOLUTION<br />

SOLUTION FOR<br />

INJECTION<br />

CARBOPLATIN INJECTION VIAL SOLUTION FOR<br />

INJECTION<br />

150MG/15ML PHARMACIA & UPJOHN<br />

(PERTH) PTY LTD.<br />

10MG/ML FAULDING<br />

PHARMACEUTICALS PLC<br />

50MG/5ML F.H. FAULDING & CO.<br />

LTD. (T/A DAVID BULL<br />

LABS)<br />

AUSTRALIA<br />

UNITED KINGDOM<br />

AUSTRALIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 499<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CARBOPLATIN INJECTION VIAL SOLUTION FOR<br />

INJECTION<br />

CARBOPLATINO SOLUTION FOR<br />

INJECTION<br />

450MG/5ML F.H. FAULDING & CO.<br />

LTD (T/A DAVID BULL<br />

LABS)<br />

AUSTRALIA<br />

150MG/15ML PHARMACIA ITALIA SPA ITALY<br />

CARBOSAN GEL 2% W/W ROWA<br />

PHARMACEUTICALS LTD<br />

CARBOSIN SOLUTION FOR<br />

INJECTION<br />

CARBOTINOL SOLUTION FOR<br />

INJECTION<br />

IRELAND<br />

10MG/ML PHARMACHEMIE BV NETHERLANDS<br />

150MG KOREA UNITED PHARM.<br />

INC.<br />

KOREA REPUBLIC<br />

CARDIFEN-10 CAPSULES 10MG PHARMACARE LIMITED REPUBLIC OF SOUTH<br />

AFRICA<br />

CARDILATE MR TABLETS 20MG NORTON HEALTHCARE<br />

LIMITED<br />

CARDILATE MR 10MG TABLETS TABLETS 10MG NORTON HEALTHCARE<br />

LIMITED<br />

CARDIOLITE DRY SUBSTANCE FOR IV<br />

INF<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NA DUPONT PHARMA GMBH GERMANY<br />

CARDIPRIL TABLETS 4.6MG BIALPORT PRODUCTOS<br />

FARMACEUTICOS SA<br />

CARDIPRIL TABLETS 9.2MG BIALPORT — PRODUTOS<br />

FARMACEUTICOS SA<br />

PORTUGAL<br />

PORTUGAL<br />

CARDURA TABLET 2MG PFIZER LIMITED UNITED KINGDOM<br />

CARDURA TABLET 4MG PFIZER LIMITED UNITED KINGDOM<br />

CARDURA TABLET 1MG PFIZER LIMITED UNITED KINGDOM<br />

CARDURA XL MODIFIED RELEASE<br />

TABLET<br />

CARDURA XL MODIFIED RELEASE<br />

TABLET<br />

4MG PFIZER LTD. UNITED KINGDOM<br />

8MG PFIZER LTD. UNITED KINGDOM<br />

CARGOSIL CREAM 5% GENEPHARM S.A. GREECE<br />

CARLOC-6.25 TABLETS 6.25MG CIPLA INDIA<br />

CARTERON 5MG CAPSULE 5MG MEDOCHEMIE LTD CYPRUS<br />

CASACOL LIQUID NA HELSINN BIREX<br />

PHARMACEUTICALS<br />

LIMITED<br />

CASCADE (FORMELY NATEX<br />

NO. 1)TABLETS<br />

COATED TABLET N/A MODERN HEALTH<br />

PRODUCTS LTD<br />

IRELAND<br />

UNITED KINGDOM<br />

CASODEX 150MG COATED TABLET 150MG ZENECA LIMITED UNITED KINGDOM<br />

CASODEX TABLETS 50MG COATED TABLET 50MG ZENECA LIMITED UNITED KINGDOM<br />

CASPOFUNGIN MSD POWD F/CONC F/SOLN F/<br />

INF<br />

CASPOFUNGIN MSD POWD. F/CONC F/SOLN<br />

F/INF<br />

CASPOFUNGIN MSD POWDER FOR SOLUTION<br />

FOR INFUSION<br />

50MG/VIAL MERCK SHARP AND<br />

DOHME LIMITED<br />

70MG/VIAL MERCK SHARP & DOHME<br />

LIMITED<br />

50MG/VIAL MERCK SHARP & DOHME<br />

LIMITED<br />

EUROPEAN COMMUNITY<br />

UNITED KINGDOM<br />

EUROPEAN COMMUNITY


EN<br />

500 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CASTOR OIL BP ORAL SOLUTION N/A LCM LTD UNITED KINGDOM<br />

CASTOR OIL BP ORAL SOLUTION 5ML LCM LTD UNITED KINGDOM<br />

CATAFLAM SUGAR COATED<br />

TABLETS<br />

50MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

CATAFLAM TABLET 50MG GEIGY PAKISTAN<br />

CATAFLAM SUGAR COATED<br />

TABLETS<br />

CATAFLAM SUGAR COATED<br />

TABLETS<br />

25MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

50MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

CATAFLAM 1.5% DROPS 15MG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

CATAFLAM RAPID COATED TABLETS 25MG NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

CATAFLAM RAPID COATED TABLETS 50 MG NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

CATHAY RISING SUN/GERARD<br />

GINGER/GINGER<br />

TABLET 180MG CATHAY OF<br />

BOURNEMOUTH LTD T/A<br />

GERARD HOUSE<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

CAVERIL TABLETS 40MG REMEDICA LTD CYPRUS<br />

CAVERIL 40 TABLETS 40MG REMEDICA LTD CYPRUS<br />

CAVERJECT POWDER FOR INJECTION 20MCG/ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

BELGIUM<br />

C-D-CALCIUM CHEWING TABLETS N/A G.STREULI & CO. AG SWITZERLAND<br />

C-D-CALCIUM EFFERVESCENT TABLET N/A G.STREULI & CO. AG SWITZERLAND<br />

CEALB (ALBUMIN 20 %) SOLUTION FOR<br />

INFUSION<br />

200G/L SANQUIN, CLB,<br />

PRODUCTS DIVISION<br />

NETHERLANDS<br />

CEALB (ALBUMIN 20%) SOL. FOR INFUSION 200G/L CLB NETHERLANDS<br />

CEANEL CONCENTRATE TOPICAL SOLUTION N/A QUINODERM LIMITED UNITED KINGDOM<br />

CECENU CAPSULES 40MG MEDAC GMBH GERMANY<br />

CECLOR MODIFIED RELEASE<br />

TABLET<br />

CECLOR MODIFIED RELEASE<br />

TABLET<br />

CECLOR MODIFIED RELEASE<br />

TABLET<br />

CECLOR GRANULES FOR ORAL<br />

SUSPEN.<br />

CECLOR GRANULES FOR ORAL<br />

SUSPEN.<br />

375MG ELI LILLY ITALIA S.P.A. ITALY<br />

500MG ELI LILLY ITALIA S.P.A. ITALY<br />

750MG ELI LILLY ITALIA S.P.A. ITALY<br />

125MG/5ML ELI LILLY ITALIA S.P.A. ITALY<br />

5% W/V ELI LILLY ITALIA S.P.A. ITALY<br />

CECLOR CAPSULES 500MG LILLY PAKISTAN<br />

CECLOR MR TABLET 750MG LILLY PAKISTAN<br />

CECLOR MR TABLET 375MG LILLY PAKISTAN


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 501<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CEFACET TABLETS 500MG LABORATOIRES<br />

NORGINE PHARMA<br />

CEFACET TABLETS 1G LABORATOIRES<br />

NORGINE PHARMA<br />

CEFACET GRANULES IN SACHETS 250MG LABORATOIRES<br />

NORGINE PHARMA<br />

CEFALOTINE MERCK 1G POWDER FOR SOL. FOR<br />

INJ.<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

1G/VIAL MERCK GENERIQUES FRANCE<br />

CEFAN POWDER FOR INJECTION 1G/VIAL DEMO ABEE GREECE<br />

CEFARIM 750MG POWDER FOR IM/IV 750MG M/S VITAPURE<br />

CORPORATION<br />

CEFIX-200 TABLETS 200MG CIPLA LTD INDIA<br />

CEFRADOX 500 CAPSULES 500MG AEGIS LTD. CYPRUS<br />

CEFTRIAXONE 500MG POWDER FOR INJECTION 500MG MEDOCHEMIE LTD CYPRUS<br />

CEFUROXIM 750MG CURASAN POWDER FOR INJECTION 750MG/VIAL CURASAN PHARMA<br />

GMBH<br />

CEFUROXIME AXETILE TABLETS 250MG SHENZHEN<br />

PHARMACEUTICAL<br />

FACTORY<br />

CEFZIL (PROCEF) TABLETS 250MG BRISTOL MYERS SQUIBB<br />

S.P.A<br />

CEFZIL (PROCEF) POWDER FOR ORAL<br />

SUSP.<br />

250MG/5ML BRISTOL MYERS SQUIBB<br />

S.P.A<br />

CEFZIL (PROCEF) TABLETS 500MG BRISTOL MYERS SQUIBB<br />

S.P.A<br />

CEGROVIT EFFERVESCENT TABLET 1G DR.GROSSMANN AG<br />

PHARMACA<br />

CELANCE 0.05MG TABLETS TABLET 0.05MG ELI LILLY & COMPANY<br />

LIMITED<br />

CELANCE 0.25MG TABLETS TABLET 0.25MG ELI LILLY & COMPANY<br />

LIMITED<br />

CELANCE 1MG TABLETS TABLET 1MG ELI LILLY & COMPANY<br />

LIMITED<br />

CELEBIX -200 CAPSULE 200MG OKASA PHARMA PVT<br />

LTD — INDIA<br />

CELEBREX HARD CAPSULES 100MG MONSANTO PLC T/A<br />

SEARLE<br />

CELEBREX HARD CAPSULES 200MG MONSANTO PLC T/A<br />

SEARLE<br />

INDIA<br />

GERMANY<br />

CHINA<br />

ITALY<br />

ITALY<br />

ITALY<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CELEBREX HARD CAPSULES 200MG PHARMACIA LIMITED UNITED KINGDOM<br />

CELEBREX HARD CAPSULES 100MG PHARMACIA LIMITED UNITED KINGDOM<br />

CELESTONE TABLETS 0.5MG SCHERING PLOUGH<br />

NV/SA<br />

CELEVAC TABLETS 500MG MONMOUTH<br />

PHARMACEUTICALS LTD.<br />

CELLCEPT CAPSULE 250MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

BELGIUM<br />

UNITED KINGDOM<br />

SWITZERLAND


EN<br />

502 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CELLCEPT 500MG TABLET 500MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

CELLIDRIN 100MG TABLET 100MG HENNIG ARZNEIMITTEL<br />

GMBH & CO. KG<br />

CELLIDRIN 300MG TABLET 300MG HENNIG ARZNEIMITTEL<br />

GMBH & CO. KG<br />

CELLUVISC EYE DROPS SOLUTION 1% ALLERGAN<br />

PHARMACEUTICALS<br />

(IRELAND) LIMITED<br />

SWITZERLAND<br />

GERMANY<br />

GERMANY<br />

IRELAND<br />

CELLUVISC LUBRICANT EYE DROPS 1% W/V ALLERGAN UNITED STATES OF<br />

AMERICA<br />

CEMAQUIN LOZENGES N/A CIMEX AG SWITZERLAND<br />

CENOVIS 1000MG VIT C<br />

NATURAL ORANGE FLAV<br />

CENOVIS 1000MG VITAMIN C<br />

NATURAL LEMON<br />

CENOVIS 50 + MULTI CAPSULE<br />

BOTTLE<br />

CENOVIS ANTIOXIDANT TABLET<br />

BOTTLE<br />

CENOVIS ANTIOXIDANT TABLET<br />

BOTTLE<br />

TABLET 1000MG FAULDING HEALTHCARE<br />

PTY LTD<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CAPSULE N/A FAULDING HEALTHCARE<br />

PTY LTD.<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD.<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD.<br />

CENOVIS ARTHRITIC AID TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS B COMPLEX TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS B GROUP AND C<br />

VITAMINS<br />

CENOVIS B GROUP PLUS TABLET<br />

BOTTLE<br />

CENOVIS CALCIUM 600MG AND<br />

VITAMIN D<br />

CENOVIS CHILDREN'S CALCIUM<br />

PLUS<br />

CENOVIS CHILDREN'S COLD AND<br />

FLU<br />

CENOVIS CHILDREN'S<br />

MULTIVITAMINS<br />

CENOVIS CHILDREN'S VIT C<br />

100MG ORANGE FL<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

TABLETS N/A FAULDING HEALTHCARE<br />

PTY LTD.<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY<br />

TABLET(CHEWABLE) 100MG FAULDING HEALHCARE<br />

PTY LTD<br />

CENOVIS COD LIVER OIL CAPSULES 275MG FAULDING HEALTHCARE<br />

PTY LTD.<br />

CENOVIS COLD AND FLU RELIEF<br />

LOZENGE<br />

CENOVIS CO-Q10<br />

UBIDECARENONE<br />

CENOVIS COUGH RELIEF LOZ. W/<br />

VIT. C AND ZN<br />

LOZENGE N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CAPSULE 30MG FAULDING HEALTHCARE<br />

PTY LTD<br />

LOZENGES N/A FAULDING HEALTHCARE<br />

PTY LTD.<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 503<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CENOVIS CYSTITIS AID WITH<br />

CRANBERRY<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS ECHINACEA COMPLEX TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS EVENING PRIMROSE OIL<br />

600MG<br />

CENOVIS EVINING PRIMROSE<br />

OIL1000MG<br />

CENOVIS EXECUTIVE B TABLET<br />

BOTTLE<br />

CENOVIS FOLIC ACID PLUS<br />

TABLET BOTTLE<br />

CENOVIS GINSENG PANAX<br />

GINSENG 500MG<br />

CENOVIS GUARANA 2000MG +<br />

GINSENG 500MG<br />

CENOVIS HEALTHY HAIR, SKIN<br />

AND NAILS<br />

CAPSULE 600MG FAULDING HEALTHCARE<br />

PTY<br />

CAPSULE 1000MG FAULDING HEALTHCARE<br />

PTY LTD<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD.<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

TABLET 500MG FAULDING HEALTHCARE<br />

PTY LTD<br />

FILM COATED TABLETS N/A FAULDING HEALTHCARE<br />

PTY LTD.<br />

CAPSULE N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS IRON PLUS TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS LECITHIN 1.2G CAPSULE 1.2G FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS MAGNESIUM PLUS TABLET N/A FAULDING HEALTHCARE<br />

PTY<br />

CENOVIS MALE FORMULA TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS MAXEPA NATURAL FISH<br />

OIL CONC.<br />

CAPSULE 1G FAULDING HEALTHCARE<br />

PTY LTD.<br />

CENOVIS MEGA E 500MG CAPSULE 500MG FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS MEGA-MULTI EXTRA<br />

STRENGTH MV AND M<br />

CENOVIS MEN'S MULTI CAPSULE<br />

BOTTLE<br />

CENOVIS MULTIVITAMIN AND<br />

MINERALS<br />

CAPSULE N/A FAULDING HEALTHCARE<br />

PTY<br />

CAPSULE N/A FAULDING HEALTHCARE<br />

PTY LTD.<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS NATURAL E500IU CAPSULE 335MG FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS ODOURLESS GARLIC CAPSULE 10MG FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS OSTEO RELIEF TABLET<br />

BOTTLE<br />

CENOVIS ST JOHN'S<br />

WORT(HYPERICUM)<br />

CENOVIS STUDENT STUDY<br />

FORMULA<br />

CENOVIS SUGARLESS C<br />

500MG(ORANGE)<br />

TABLETS N/A FAULDING HEALTHCARE<br />

PTY LTD.<br />

TABLET 340MG FAULDING HEALTHCARE<br />

PTY LTD<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA


EN<br />

504 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CENOVIS VALERIAN FORMULA TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS VITAMIN B6 TABLET 50MG FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS VITAMIN C 1000MG<br />

TABLET BOTTLE<br />

CENOVIS VITAMIN C 250MG NAT.<br />

ORANGE FLV.<br />

CENOVIS WOMEN'S MULTI<br />

CAPSULE BOTTLE<br />

TABLET 1000MG FAULDING HEALTHCARE<br />

PTY LTD.<br />

TABLET 250MG FAULDING HEALTHCARE<br />

PTY LTD<br />

CAPSULES N/A FAULDING HEALTHCARE<br />

PTY LTD.<br />

CENOVIS YEAST 300MG TABLET 300MG FAULDING HEALTHCARE<br />

PTY LTD<br />

CENOVIS ZINC PLUS 25MG TABLET 25MG FAULDING HEALTHCARE<br />

PTY<br />

CENVOVIS GINKGO PLUS TABLET N/A FAULDING HEALTHCARE<br />

PTY LTD<br />

CEPHADAR CAPSULES 250MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

CEPHADAR GRANULES FOR ORAL<br />

SUSP.<br />

CEPHADAR GRANULES FOR ORAL<br />

SUSP.<br />

125MG/5ML DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

125MG/5ML DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

CEPHALEXIN CAPSULES 250MG NORTON HEALTHCARE<br />

LIMITED<br />

CEPHALEXIN CAPSULES 500MG NORTON HEALTHCARE<br />

LIMITED<br />

CEPHALEXIN TABLETS 250MG NORTON HEALTHCARE<br />

LIMITED<br />

CEPHALEXIN TABLETS 500MG NORTON HEALTHCARE<br />

LIMITED<br />

CEPHALEXIN ORAL SUSPENSION 125MG/5ML NORTON HEALTHCARE<br />

LIMITED<br />

CEPHALEXIN ORAL SUSPENSION 250MG/5ML NORTON HEALTHCARE<br />

LIMITED<br />

CEPHALEXIN (TENKOREX)<br />

125MG/5ML<br />

CEPHALEXIN (TENKOREX)<br />

250MG/5ML<br />

SUSPENSION 125MG/5ML KENT<br />

PHARMACEUTICALS LTD.<br />

SUSPENSION 250MG/5ML KENT<br />

PHARMACEUTICALS<br />

CEPHALEXIN 250MG CAPSULE 250MG KENT<br />

PHARMACEUTICALS LTD.<br />

CEPHALEXIN 500MG CAPSULE 500MG KENT<br />

PHARMACEUTICALS LTD.<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

JORDAN<br />

JORDAN<br />

JORDAN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CEPHALEXIN-RATIOPHARM 500 FILM COATED TABLET 500MG RATIOPHARM GMBH GERMANY<br />

CEPHOS CAPSULE 500MG LABORATORIO<br />

FARMACEUTICO<br />

C.T.S.R.L.<br />

ITALY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 505<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CEPOREX HARD CAPSULES 500MG GLAXO WELLCOME UK<br />

LIMITED<br />

CEPOREX HARD CAPSULES 500MG GLAXO WELLCOME UK<br />

LIMITED<br />

CEPOREX CAPSULES 250MG CAPSULES 250MG GLAXO WELLCOME UK<br />

LTD<br />

CEPOREX CAPSULES 500MG CAPSULES 500MG GLAXO WELLCOME UK<br />

LTD<br />

CEPOREX SYRUP 125MG/5ML SYRUP 125MG/5ML GLAXO WELLCOME UK<br />

LTD<br />

CEPOREX SYRUP 250/5ML SYRUP 250MG/5ML GLAXO WELLCOME UK<br />

LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CEREPAR TABLETS 75MG MEPHA PHARMA AG SWITZERLAND<br />

CERETEC POWDER FOR INJECTION 0.5MG/VIAL NYCOMED AMERSHAM<br />

PLC<br />

CEROX TOPICAL SOLUTION N/A SPA ITALIANA<br />

LABORATORI BOUTY<br />

CEROXIM TABLETS 250MG TABLETS 250MG RANBAXY<br />

LABORATORIES LTD.<br />

CERUMOL EAR DROPS EAR DROPS N/A LABORATORIES FOR<br />

APPLIED BIOLOGY LTD<br />

UNITED KINGDOM<br />

ITALY<br />

INDIA<br />

UNITED KINGDOM<br />

CETAVLEX ANTISEPTIC CREAM 0.5% W/W ZENECA LIMITED UNITED KINGDOM<br />

CETAVLEX CREAM CREAM 1.25% V/ W BIOGLAN<br />

LABORATORIES LTD<br />

CETILSAN SUGAR FREE LOZENGES N/A LABORATORIO CHIMICO<br />

FARMACEUTICO A.<br />

SELLA S.R.L.<br />

CETILSAN LOZENGES N/A LABORATORIO CHIMICO<br />

FARMACEUTICO A.<br />

SELLA S.R.L.<br />

CETOMACROGOL CREAM A BP CREAM 9% W/W ADAMS HEALTHCARE<br />

LIMITED<br />

CETOR PWD. FOR SOL. FOR INF. 500U SANQUIN, CLB,<br />

PRODUCTS DIVISION<br />

CETRIMIDE ANTISEPTIC FIRST AID<br />

CREAM<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

CREAM 0.5% W/W ANGLIAN PHARMA PLC UNITED KINGDOM<br />

CETRIMIDE CREAM BP CREAM 0.5% W/W ADAMS HEALTHCARE<br />

LIMITED<br />

CETROTIDE SOLUTION FOR<br />

INJECTION.<br />

CETROTIDE SOLUTION FOR<br />

INJECTION<br />

CETROTIDE POWDER AND SOLVENT<br />

F/SOLUTION F/INJECTION<br />

CETROTIDE (X1VIAL) POWDER AND SOLVENT<br />

F/SOLUTION F/INJECTION<br />

CETROTIDE (X7VIALS) POWDER AND SOLVENT<br />

F/SOLUTION F/INJECTION<br />

UNITED KINGDOM<br />

0.25MG/ML ASTA MEDICA GERMANY<br />

3MG/3ML ASTA MEDICA GERMANY<br />

3MG/VIAL SERONO EUROPE<br />

LIMITED<br />

0.25MG/VIAL SERONO EUROPE<br />

LIMITED<br />

0.25MG/VIAL SERONO EUROPE<br />

LIMITED<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY


EN<br />

506 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CEZIDIN POWDER FOR INJECTION 1G/VIAL DEMO ABEE GREECE<br />

CHAPSTICK — CHERRY LIP BALM N/A WHITEHALL<br />

INTERNATIONAL INC<br />

CHAPSTICK — REGULAR LIP BALM N/A WHITEHALL<br />

INTERNATIONAL INC.<br />

CHAPSTICK — SUNBLOCK 15 LIP BALM N/A WHITEHALL<br />

INTERNATIONAL INC.<br />

CHARCOALTABLETS 125MG TABLET 125MG G R LANE HEALTH<br />

PRODUCTS LTD<br />

CHEMITRIM CAPSULES N/A BIOMEDICA FOSCAMA<br />

INDUSTRIA CHIMICO<br />

FARMACEUTICA S.P.A.<br />

CHEMITRIM ‘FORTE’ TABLET N/A BIOMEDICA FOSCAMA<br />

INDUSTRIA CHIMICO<br />

FARMACEUTICA S.P.A.<br />

CHIBROXIN 0.3% DPS EYE DROPS 0.3% W/V MERCK SHARP & DOHME<br />

B.V.<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

NETHERLANDS<br />

CHIBROXINE EYE DROPS 0.3%W/W MSD PAKISTAN<br />

CHIBROXINE 0.3 COLLYRE EYE DROPS 3MG/ML MERCK SHARP & DOHME<br />

B.V.<br />

NETHERLANDS<br />

CHILBLAIN CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM<br />

CHILDREN'S ADVIL SUSPENSION SUSPENSION NA WHITEHALL — ROBINS CANADA<br />

CHILDREN'S DIMETAPP COLD<br />

AND ALLERGY<br />

ELIXIR NA WITEHALL<br />

INTERNATIONAL<br />

UNITED STATES OF<br />

AMERICA<br />

CHIMAX TABLET 250MG CHIRON BV NETHERLANDS<br />

CHLORAMPHENICAL EYE DROPS EYE DROPS 0.5% W/V SCHERING-PLOUGH<br />

LIMITED<br />

CHLORAMPHENICOL BP 250MG CAPSULE 250MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

CHLORAMPHENICOL EYE<br />

OINTMENT 1% BP<br />

CHLORASEPT 2000 ANTISEPTIC<br />

SOL.<br />

CHLORHEXIDINE GLUCONATE<br />

NATURAL FLAVOUR<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

EYE OINTMENT 1% W/W PL 00156/0049 UNITED KINGDOM<br />

TOPICAL SOLUTION N/A BAXTER HEALTHCARE<br />

LIMITED<br />

OROMUCOSAL<br />

SOLUTION<br />

0.2% W/V ADAMS HEALTHCARE<br />

LIMITED<br />

CHLOROQUINE PHOSPHATE TABLETS 100MG PHARMAMED LTD. MALTA<br />

CHLOROQUINE PHOSPHATE TABLETS 250MG PHARMAMED LTD. MALTA<br />

CHLOROQUINE PHOSPHATE SOLUTION FOR<br />

INJECTION<br />

CHLOROQUINE PHOSPHATE SOLUTION FOR<br />

INJECTION<br />

CHLOROQUINE PHOSPHATE BP<br />

250MG<br />

40MG/ML PHARMAMED<br />

PARENTERALS LTD.<br />

80MG/2ML PHARMAMED<br />

PARENTERALS LTD.<br />

TABLET 250MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

CHLORPAMIDE BP 250MG TABLET 250MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALTA<br />

MALTA<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 507<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CHLORPHENIRAMINE BP 4MG TABLET 4MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

CHLORPROMAZINE COATED TABLETS 25MG CLONMEL HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

IRELAND<br />

CHLORPROMAZINE TABLETS 25MG REMEDICA LTD. CYPRUS<br />

CHLORPROMAZINE BP 25MG TABLETS 25MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

CHLORPROPAMIDE TABLET 250MG MEDOCHEMIE LTD CYPRUS<br />

CHLORPROPAMIDE TABLETS 250MG PHARMAMED LTD. MALTA<br />

CHLORPROPAMIDE BP 100MG TABLET 100MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

CHLORURE DE THALLIUM<br />

[(201)TI] CIS BIO<br />

SOLUTION FOR<br />

INJECTION<br />

CHOLECIS INTRAVENEOUS<br />

SOLUTION<br />

CHOLERA VACCINE BEHRING SUSPENSION FOR<br />

INJECTION<br />

CHORAGEN 5000 POW. FOR INJ. AND<br />

SOLVENT<br />

37 MBQ/ML CIS BIO INTERNATIONAL FRANCE<br />

NA CIS BIO INTERNATIONAL FRANCE<br />

N/A CHIRON BEHRING GMBH<br />

&CO<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

5000 I.E. FERRING GMBH GERMANY<br />

CHYMOL EMOLLIENT BALM OINTMENT NS ANGLIAN PHARMA PLC UNITED KINGDOM<br />

CIBACEN FILM C. TABLETS<br />

DIVISIBLE<br />

5MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

CIBACEN TABLETS 10MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

CICATRIN POWDER N/A WELLCOME<br />

FOUNDATION LTD.<br />

CICATRIN CREAM N/A WELLCOME<br />

FOUNDATION LTD.<br />

SWITZERLAND<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CICATRIN POWDER POWDER NA GLAXOWELLCOME PAKISTAN<br />

CICLOFOSFAMIDA FILAXIS LYOPHILIZED POWDER<br />

FOR INJECTION<br />

CICLOFOSFAMIDA FILAXIS LYOPHILIZED POWDER<br />

FOR INJECTION<br />

1G LABORATORIOS FILAXIS<br />

SA<br />

200MG LABORATORIOS FILAXIS<br />

SA<br />

CIDOMYCIN EYE/EAR DROPS EYE/EAR DROPS 0.3% W/V ROUSSEL<br />

LABORATORIES LIMITED<br />

CIDOMYCIN INJECTION ADULT —<br />

80MG/2ML<br />

CIDOMYCIN PAEDIATRIC<br />

INJECTABLE 20MG/2ML<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

80MG/2ML ROUSSEL<br />

LABORATORIES LIMITED<br />

20MG/2ML ROUSSEL<br />

LABORATORIES LIMITED<br />

ARGENTINA<br />

ARGENTINA<br />

CIFEX ORAL SUSPENSION 100MG/5ML AEGIS LTD. CYPRUS<br />

CIFEX 200 TABLETS 200MG AEGIS LTD. CYPRUS<br />

CIFEX 400 TABLETS 400MG AEGIS LTD. CYPRUS<br />

CIFLURON 250MG FILMCOATED<br />

TABLETS<br />

FILM COATED TABLETS NA IL KO ILAC VE KOZMETIK<br />

SAN. A.S. — TURKEY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

TURKEY


EN<br />

508 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CIFRAN SOLUTION FOR<br />

INJECTION<br />

200MG RANBAXY<br />

LABORATORIES LTD.<br />

CILEST TABLET N/A JANSSEN-CILAG AG SWITZERLAND<br />

CILOPRIN CUM ANAESTHETICO DROPS N/A JANSSEN-CILAG AG SWITZERLAND<br />

CILOXAN OPHTHALMIC SOLUTION 3MG/ML S.A. ALCON-COUVREUR<br />

N.V.<br />

CIMEDINE TABLETS 800MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

CIMET (CIMETIDINE TABLETS USP) TABLET 200MG IPCA LABORATORIES<br />

LIMITED<br />

CIMET-400 (CIMETIDINE TABLETS<br />

USP)<br />

TABLET 400MG IPCA LABORATORIES<br />

LIMITED<br />

CIMETIDINE TABLETS 200MG NORTON HEALTHCARE<br />

LIMITED<br />

CIMETIDINE TABLETS 400MG NORTON HEALTHCARE<br />

LIMITED<br />

CIMETIDINE TABLETS 800MG NORTON HEALTHCARE<br />

LIMITED<br />

CINAZYN TABLETS 25MG ITALCHIMICI SPA ITALY<br />

CINAZYN CAPSULE 75MG ITALCHIMICI SPA ITALY<br />

CINNARIZINE TABLETS 15MG NORTON HEALTHCARE<br />

LIMITED<br />

CIPLIN (COTRIMOXAZOLE<br />

TABLETS IP)<br />

INDIA<br />

BELGIUM<br />

JORDAN<br />

INDIA<br />

INDIA<br />

TABLET N/A CIPLA LTD INDIA<br />

CIPLIN SUSPENSION SUSPENSION N/A CIPLA LTD — INDIA INDIA<br />

CIPLOX SOLUTION FOR<br />

INJECTION<br />

2MG/ML CIPLA LTD. INDIA<br />

CIPLOX-250 TABLETS TABLETS 250MG CIPLA LTD. INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CIPRAM TABLET 20MG H. LUNDBECK A/S DENMARK<br />

CIPRAM TABLET 20MG LUNDBECK PAKISTAN<br />

CIPRO HC OTIC SUSPENSION N/A ALCON LABORATORIES<br />

INC.<br />

CIPRO HC OTIC SUSPENSION EAR DROPS N/A ALCON CUSI S.A. SPAIN<br />

CIPROBAY 100 INFUSION SOLUTION 100MG/50ML BAYER VITAL GMBH &<br />

CO. KG<br />

CIPROBAY 200 INFUSION SOLUTION 200MG/100ML BAYER VITAL GMBH &<br />

CO. KG<br />

CIPROBAY 250 FILM-COATED TABLET 250MG BAYER VITAL GMBH &<br />

CO. KG<br />

CIPROBAY 500 FILM-COATED TABLET 500MG BAYER VITAL GMBH &<br />

CO. KG<br />

CIPROBID-250 TABLETS 250MG CADILA HEALTHCARE<br />

LIMITED<br />

UNITED STATES OF<br />

AMERICA<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

INDIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 509<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CIPRODAR FILM-COATED 250MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

CIPRODAR TABLETS 500MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

CIPROFLOXACIN INJECTION USP SOL FOR INJ 2MG/ML VYSALI<br />

PHARMACEUTICALS<br />

LIMITED<br />

CIPROFLOXACIN TABLETS USP<br />

CIFROTIL<br />

JORDAN<br />

JORDAN<br />

INDIA<br />

FILM COATED TABLET 250MG TABLETS (INDIA) LIMITED INDIA<br />

CIPROXIN TABLET 250MG BAYER PAKISTAN<br />

CIPROXIN 100 INFUSION SOLUTION 100MG/50ML BAYER VITAL GMBH &<br />

CO. KG<br />

CIPROXIN 200 INFUSION SOLUTION 200MG/100ML BAYER VITAL GMBH &<br />

CO. KG<br />

CIPROXIN 250 FILM-COATED TABLET 250MG BAYER VITAL GMBH &<br />

CO. KG<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

CIPROXIN 250 FILM COATED TABLET 250MG BAYER PAKISTAN<br />

CIPROXIN 400 INFUSION SOLUTION 400MG/200ML BAYER VITAL GMBH &<br />

CO. KG<br />

CIPROXIN 500 FILM-COATED TABLET 500MG BAYER VITAL GMBH &<br />

CO. KG<br />

CIPROXIN 750 FILM-COATED TABLET 750MG BAYER VITAL GMBH &<br />

CO. KG<br />

CIROK SOLUTION FOR<br />

INJECTION<br />

2MG/ML KOREA UNITED PHARM.<br />

INC.<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

KOREA REPUBLIC<br />

CIRRUS CAPSULE N/A U.C.B. S.A. BELGIUM<br />

CISPLATIN 100MG/100ML SOLUTION FOR<br />

INJECTION<br />

CISPLATIN 10MG/10ML SOLUTION FOR<br />

INJECTION<br />

CISPLATIN 50MG/50ML SOLUTION FOR<br />

INJECTION<br />

CISPLATIN INJECTION B.P SOLUTION FOR<br />

INJECTION<br />

CISPLATIN INJECTION SOLUTION SOLUTION FOR<br />

INFUSION<br />

CISPLATINE MERCK 10MG/10ML SOL. TO DILUTE FOR<br />

PERFUS<br />

CISPLATINE MERCK 50MG/50ML SOL. TO DILUTE FOR<br />

PERFUS<br />

CISPLATINO SOLUTION FOR<br />

INJECTION<br />

CISPLATINO SOLUTION FOR<br />

INJECTION<br />

CITANEST OCTAPRESSIN SOLUTION FOR<br />

INJECTION<br />

1MG/ML PHARMACIA & UPJOHN<br />

(PERTH) PTY LTD.<br />

1MG/ML PHARMACIA & UPJOHN<br />

(PERTH) PTY LTD.<br />

1MG/ML PHARMACIA & UPJOHN<br />

(PERTH) PTY LTD.<br />

N/A SERUM INSTITUTE OF<br />

INDIA LTD.<br />

1MG/ML FAULDING<br />

PHARMACEUTICALS PLC<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

INDIA<br />

10MG/10ML MERCK GENERIQUES FRANCE<br />

50MG/50ML MERCK GENERIQUES FRANCE<br />

50MG/50ML PHARMACIA ITALIA SPA ITALY<br />

10MG/10ML PHARMACIA ITALIA SPA ITALY<br />

N/A ASTRA LAKEMEDEL AB SWEDEN<br />

UNITED KINGDOM


EN<br />

510 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CITOMID RU SOLUTION FOR<br />

INJECTION<br />

CITOMID RU SOLUTION FOR<br />

INJECTION<br />

1MG/2ML LEMERY S.A. MEXICO<br />

2MG/2ML LEMERY S.A. MEXICO<br />

CITRAMAG POWDER EFFERVESCENT POWDER N/A BOIGLAN<br />

LABORATORIES<br />

CITRATO ESPRESSO S<br />

PELLEGRINO<br />

ORAL POWDER 7.12G / 40G SYNTHELABO S.P.A. ITALY<br />

CITROVENOT TABLET 250MG BROS LTD GREECE<br />

CITROVENOT TABLET 500MG BROS LTD GREECE<br />

UNITED KINGDOM<br />

CLABAT DRY SYRUP N/A PT INTERBAT INDONESIA<br />

CLABAT 500 FILM COATED CAPLET N/A PT INTERBAT INDONESIA<br />

CLABAT 500 FILM-COATED TABLET N/A PT INTERBAT INDONESIA<br />

CLABAT DRY SYRUP SYRUP N/A PT INTERBAT INDONESIA<br />

CLABAT FORTE DRY SYRUP N/A PT INTERBAT INDONESIA<br />

CLABAT FORTE DRY SYRUP 60 ML DRY SYRUP N/A PT INTERBAT INDONESIA<br />

CLACIN CAPSULES 150MG KOREA UNITED PHARM.<br />

INC.<br />

CLAFORAN 0.5G POWDER FOR IV-IM<br />

INJECT.<br />

CLAFORAN 1G POWDER FOR IV-IM<br />

INJECT.<br />

0.5G LABORATOIRES AVENTIS FRANCE<br />

1G LABORATOIRES AVENTIS FRANCE<br />

CLAFORAN 1G IM POWDER FOR INJECTION 1G LABORATOIRES AVENTIS FRANCE<br />

KOREA REPUBLIC<br />

CLAMIDE TABLET 5MG TABLET 5MG HOVID SDN BHD MALAYSIA<br />

CLARICIDE TABLETS 250MG BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

CLARICIDE FILM COATED TABLETS 500MG BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

CLARIDAR FILM-COATED TABLETS 250MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

TURKEY<br />

TURKEY<br />

JORDAN<br />

CLARINASE REPETABS N/A SCHERING-PLOUGH S.A. BELGIUM<br />

CLARITHROMYCIN/GENEPHARM TABLETS 500MG GENEPHARM S.A. GREECE<br />

CLARITHROMYCIN/GENEPHARM TABLETS 250MG GENEPHARM S.A. GREECE<br />

CLARITINE TABLETS 10MG SCHERING-PLOUGH<br />

NV/SA<br />

BELGIUM<br />

CLARITINE SYRUP 1MG/ML SCHERING-PLOUGH S.A. BELGIUM<br />

CLAVAMOX DT 400 POWDER F/ORAL SUSP. NA LABORATORIOS BIAL PORTUGAL<br />

CLENASMA TABLET 0.02MG BIOMEDICA FOSCAMA<br />

INDUSTRIA CHIMICO<br />

FARMACEUTICA S.P.A.<br />

CLENASMA SYRUP 0.1MG/100ML BIOMEDICA FOSCAMA<br />

INDUSTRIA CHIMICO<br />

FARMACEUTICA S.P.A.<br />

ITALY<br />

ITALY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 511<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CLEXANE SOLUTION FOR<br />

INJECTION<br />

CLEXANE SOLUTION FOR<br />

INJECTION<br />

CLEXANE SOLUTION FOR<br />

INJECTION<br />

CLEXANE SOLUTION FOR<br />

INJECTION<br />

CLEXANE SOLUTION FOR<br />

INJECTION<br />

CLEXANE 100MG/ML (FOR SC<br />

USE)<br />

20MG/0.2ML LABORATOIRES AVENTIS FRANCE<br />

40MG/0.4ML LABORATOIRES AVENTIS FRANCE<br />

60MG/0.6ML BELLON, RHONE-<br />

POULENC RORER<br />

80MG/0.8ML BELLON, RHONE-<br />

POULENC RORER<br />

100MG/1ML BELLON, RHONE-<br />

POULENC RORER<br />

INJECTABLE SOLN. IN PFS 100MG/ML BELLON, RHONE-<br />

POULENC RORER<br />

CLEXANE 20MG/0.2ML INJECTABLE SOLN. IN PFS 20MG/0.2ML BELLON, RHONE-<br />

POULENC RORER<br />

CLEXANE 40MG/0.4ML INJECTABLE SOLN. IN PFS 40MG/0.4ML BELLON, RHONE-<br />

POULENC RORER<br />

CLEXANE 60MG/0.6ML (FOR SC<br />

USE)<br />

CLEXANE 80MG/0.8ML (FOR SC<br />

USE)<br />

INJECTABLE SOLN. IN PFS 60MG/0.6ML BELLON, RHONE-<br />

POULENC RORER<br />

INJECTABLE SOLN. IN PFS 80MG/0.8ML BELLON, RHONE-<br />

POULENC RORER<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

CLINDAZYN INJECTABLE SOLUTION 300MG/2ML LEMERY, S.A. DE C.V. MEXICO<br />

CLINOMEL N4-550 SOLUTION FOR<br />

INFUSION<br />

CLINOMEL N5-800 SOLUTION FOR<br />

INFUSION<br />

CLINOMEL N5-800 SOLUTION FOR<br />

INFUSION<br />

CLINOMEL N6-900 SOLUTION FOR<br />

INFUSION<br />

CLINOMEL N6-900 SOLUTION FOR<br />

INFUSION<br />

CLINOMEL N7-1000 EMULSION FOR<br />

INFUSION<br />

CLINOMEL N7-1000 SOLUTION FOR<br />

INFUSION<br />

NA BAXTER HEALTHCARE<br />

LIMITED<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

NA BAXTER HEALTHCARE<br />

LIMITED<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

NA BAXTER HEALTHCARE<br />

LIMITED<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

NA BAXTER HEALTHCARE<br />

LIMITED<br />

CLINT 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS<br />

CLISMA LAX RECTAL SOLUTION N/A SOFAR SPA ITALY<br />

CLOBAZAM 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS<br />

CLOBEDERM-E CREAM 0.05G/100G ATCO LABORATORIES<br />

(PVT) LTD<br />

CLOBETASOL PROPIONATE<br />

TOPICAL SOLUTION<br />

TOPICAL SOLUTION 0.5MG/G TARO<br />

PHARMACEUTICALS USA<br />

CLOCIP 1% W/W/ CREAM CREAM 1% CIPLA LTD. INDIA<br />

CLOFENAC-25 ENTERIC COATED<br />

TABLETS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

PAKISTAN<br />

UNITED STATES OF<br />

AMERICA<br />

25MG HOVID SDN.BHD. MALAYSIA


EN<br />

512 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CLOFENAC-25 ENTERIC COATED<br />

TABLET<br />

25MG HOVID SDN. BHD<br />

(FORMERLY HO YAN<br />

HOR SDN.BHD)<br />

MALAYSIA<br />

CLOMFRANIL 10MG TABLET 10MG NOVARTIS PAKISTAN<br />

CLOMFRANIL 25MG TABLETS 25MG NOVARTIS PAKISTAN<br />

CLOMID 50MG TABLET 50MG LABORATOIRES MARION<br />

MERRELL DOW<br />

CLOMID TABLETS 50 MG TABLETS 50 MG AVENTIS PHARMA<br />

LIMITED<br />

CLOMIFENE TABLETS BP 50MG CP PHARMACEUTICALS<br />

LIMITED<br />

CLOMIPHENE CITRATE<br />

(SEROPHENE) 50MG<br />

TABLET 50MG TEVA PHARMACEUTICAL<br />

INDUSTRIES LIMITED<br />

CLOMIPRAMINE CAPSULES 10MG NORTON HEALTHCARE<br />

LIMITED<br />

CLOMIPRAMINE CAPSULES 25MG NORTON HEALTHCARE<br />

LIMITED<br />

CLOMIPRAMINE CAPSULES 50MG NORTON HEALTHCARE<br />

LIMITED<br />

CLOMIPRAMINE CAPSULE 10 MG APPROVED<br />

PRESCRIPTION SERVICES<br />

LIMITED<br />

CLOMIPRAMINE BP CAPSULES 25MG APPROVED<br />

PRESCRIPTION SERVICES<br />

LIMITED<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ISRAEL<br />

CLOMIPRAN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS<br />

CLOMIPRAN 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS<br />

CLONEA CREAM 10MG/G ALPHAPHARM PTY<br />

LIMITED<br />

CLONIL TABLETS 25MG INTAS<br />

PHARMACEUTICALS LTD.<br />

CLONIL-10 TABLETS 10MG INTAS<br />

PHARMACEUTICALS LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

CLOPERAN 10MG TABLETS REMEDICA LTD. CYPRUS<br />

CLOPIXOL TABLET 25MG H. LUNDBECK A/S DENMARK<br />

CLOPIXOL TABLET 10MG H. LUNDBECK A/S DENMARK<br />

CLOPIXOL TABLET 2MG H. LUNDBECK A/S DENMARK<br />

CLOPIXOL DROPS 20MG/ML H. LUNDBECK A/S DENMARK<br />

CLOPIXOL DEPOT INJECTION<br />

200MG/ML<br />

CLOPIXOL-ACUPHASE INJECTION<br />

50MG/ML<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

INDIA<br />

INDIA<br />

200MG/ML H. LUNDBECK A/S DENMARK<br />

50MG/ML H. LUNDBECK A/S DENMARK<br />

CLOTAM (CLOTAN) CAPSULE 200MG GEA FARMACEUTISK<br />

FABRIK<br />

DENMARK<br />

CLOTRI-DENK 1% CREAM CREAM 10MG/G E. DENK OHG GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 513<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CLOTRI-DENK 100 VAGINAL VAGINAL TABLET 100MG E. DENK OHG GERMANY<br />

CLOTRIMADERM CREAM 1% W/W CREAM 1% W/W TARO<br />

PHARMACEUTICALS INC.<br />

CANADA<br />

CLOVE OIL BP DENTAL SOLUTION 100%V/V LCM LTD UNITED KINGDOM<br />

CLOXACILLIN 250 CAPSULES 250MG REMEDICA LTD CYPRUS<br />

CLOXACILLIN 250 CAPSULES 250MG AEGIS LTD. CYPRUS<br />

CLOXACILLIN 500 CAPSULES 500MG AEGIS LTD. CYPRUS<br />

CLOZAPINE TABLETS 25MG MYLAN<br />

PHARMACEUTICALS INC<br />

CLOZAPINE TABLETS 100MG MYLAN<br />

PHARMACEUTICALS INC<br />

CLOZOLE CREAM 1% W/W CREAM 1% W/W SM PHARMACEUTICALS<br />

SDN BHD<br />

CO-AMILOFRUSE TABLETS NA CP PHARMACEUTICALS<br />

LIMITED<br />

CO-AMILOZIDE TABLETS N/A CP PHARMACEUTICALS<br />

LTD.<br />

CO-AMILOZIDE TABLETS N/A CP PHARMACEUTICALS<br />

LTD.<br />

COAPROVEL 150/12.5MG<br />

TABLETS<br />

TABLET N/A SANOFI PHARMA<br />

BRISTOL-MYERS SQUIBB<br />

SNC<br />

COAPROVEL 300/12.5MG TABLET N/A SANOFI PHARMA<br />

BRISTOL-MYERS SQUIBB<br />

SNC<br />

CO-CODAMOL TABLETS N/A CP PHARMACEUTICALS<br />

LTD.<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

MALAYSIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

UNITED KINGDOM<br />

CO-CODAMOL TABLETS N/A HN NORTON & CO LTD UNITED KINGDOM<br />

CO-CODAMOL TABLETS 8/500MG M & A PHARMACHEM<br />

LIMITED<br />

COCOIS OINTMENT N/A BIOGLAN<br />

LABORATORIES LTD<br />

CO-DANTHRAMER SUSPENSION SUSPENSION N/A NAPP LABORATORIES<br />

LIMITED<br />

CODEINE LINCTUS BP ORAL SOLUTION 15MG/5ML WILLIAM RANSOM &<br />

SON PLC<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CODEINE LINCTUS BP ORAL SOLUTION N/A LCM LTD UNITED KINGDOM<br />

CODEINE PHOSPHATE TABLETS<br />

BP<br />

CODEINE PHOSPHATE TABLETS<br />

BP<br />

CODEINE PHOSPHATE TABLETS<br />

BP<br />

CODEINE PHOSPHATE TABLETS<br />

BP 30MG<br />

TABLETS 15MG CP PHARMACEUTICALS<br />

LTD.<br />

TABLETS 30MG CP PHARMACEUTICALS<br />

LTD.<br />

TABLETS 60MG CP PHARMACEUTICALS<br />

LTD.<br />

TABLET 30MG CP PHARMACEUTICALS<br />

LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

514 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CO-DIOVAN FILM-COATED TABLETS N/A NOVARTIS<br />

FARMACEYTICA S.A. -<br />

SPAIN<br />

CO-DIOVAN 80/12.5MG FILM COATED TABLETS N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

CODIPRONT CAPSULES WITH SUST<br />

ACTION<br />

SPAIN<br />

SWITZERLAND<br />

N/A HEINRICH MACK NACHF GERMANY<br />

CODIPRONT SYRUP N/A HEINRICH MACK NACHF GERMANY<br />

CODIPRONT CUM EXPECTORANS CAPSULES N/A PFIZER AG SWITZERLAND<br />

CODIPRONT CUM EXPECTORANS SYRUP N/A PFIZER AG SWITZERLAND<br />

CODIPRONT CUM EXPECTORANS ORAL SUSPENSION NA PFIZER AG SWITZERLAND<br />

CODIPRONT CUM EXPECTORANS CAPSULES NA PFIZER AG SWITZERLAND<br />

CODIS TABLETS TABLET N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

CO-DYDRAMOL TABLETS N/A NORTON HEALTHCARE<br />

LIMITED<br />

COFLOX-500 TABLETS 500MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

COFSED LINCTUS ORAL SOLUTION N/A GALEN LIMITED UNITED KINGDOM<br />

COFSED PAEDIATRIC LINCTUS ORAL SOLUTION N/A GALEN LIMITED UNITED KINGDOM<br />

COLCHICINE TABLETS BP TABLETS 500MCG CP PHARMACEUTICALS<br />

LTD.<br />

COLCHICINE TABLETS BP 500<br />

MICROGRAMS<br />

TABLET 500MCG CP PHARMACEUTICALS<br />

LTD<br />

COLD CREAM SALICYLE CREAM N/A LABORATOIRES LA<br />

ROCHE-POSAY<br />

COLESTID GRANULES 5G PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

COLIRCUSI PILOCARPINA 2% EYE<br />

DROPS<br />

INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

BELGIUM<br />

EYE DROPS 2% ALCON CUSI SA SPAIN<br />

COLLOMACK SOLUTION N/A HEINRICH MACK NACHF.<br />

GMBH & CO. KG<br />

GERMANY<br />

COLLU-HEXTRIL 0.2% SPRAY SOLUTION 0.2% W/V PARKE DAVIS FRANCE<br />

COLOFAC SUGAR COATED TABLET 135MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

COLOFAC RETARD CAPSULE 200MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

NETHERLANDS<br />

NETHERLANDS<br />

COLOMYCIN TABLETS 1.5MU PHARMAX LIMITED UNITED KINGDOM<br />

COLOMYCIN SYRUP 250,000 U/5ML PHARMAX LIMITED UNITED KINGDOM<br />

COLOMYCIN INJECTION POWDER FOR<br />

RECONSTITUTION<br />

COLOMYCIN INJECTION POWDER FOR<br />

RECONSTITUTION<br />

0.5MU PHARMAX LIMITED UNITED KINGDOM<br />

1MU PHARMAX LIMITED UNITED KINGDOM<br />

COLOMYCIN STERILE POWDER STERILE POWDER 1G PHARMAX LIMITED UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 515<br />

Trade Name Dosage Form Dose MA Holder Country<br />

COLOSPASMIN FORTE TABLETS 135MG EGYPTIAN<br />

INTERNATIONAL<br />

PHARMACEUTICAL<br />

INDUSTRIES CO (EIPICO)<br />

COLPOCINT-T SOLUTION FOR<br />

INJECTION<br />

COLPOSEPTINE GYNAECOLOGICAL<br />

TABLETS<br />

EGYPT<br />

500MG/1000ML DEMO ABEE GREECE<br />

N/A LABORATOIRE<br />

THERAMEX<br />

COLPOTROPHINE VAGINAL CAPSULE 0.01G LABORATOIRE<br />

THERAMEX<br />

COLPOTROPHINE 1% CREAM 1G/100G LABORATOIRE<br />

THERAMEX<br />

FRANCE<br />

MONACO<br />

MONACO<br />

COLSOR CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM<br />

COLSOR LOTION TOPICAL SOLUTION N/A J PICKLES & SONS UNITED KINGDOM<br />

COLTRAMYL 4MG TABLET 4MG LABORATOIRES<br />

ROUSSEL<br />

COLTRAMYL 4MG/2ML SOLUTION FOR IM<br />

INJECTION<br />

COLYTE POWDER FOR ORAL<br />

SOLUTION<br />

4MG/2ML LABORATOIRES<br />

ROUSSEL<br />

FRANCE<br />

FRANCE<br />

N/A SCHWARZ PHARMA INC. UNITED STATES OF<br />

AMERICA<br />

COMAZOL CREAM 1% W/W CREAM 1% W/W CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

MALAYSIA<br />

COMBACID N GEL N/A G.STREULI & CO. AG SWITZERLAND<br />

COMBINATION Q-BIOCHEMIC TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

COMBIVENT UDVS INHALATION SOLUTION N/A BOEHRINGER INGELHEIM<br />

LTD<br />

COMPOUND BENZOIN TINCTURE<br />

BP<br />

COMPOUND SOD.LACTATE WITH<br />

5%W/V GLUCOSE<br />

COMPOUND SODIUM LACTATE IV<br />

INFUSION<br />

COMPOUND SODIUM LACTATE<br />

IVI BP -HARTMANN<br />

COMPOUND THYMOL GLYCERIN<br />

BP<br />

CONC. FOR INHALATION<br />

SOLN<br />

N/A WILLIAM RANSOM &<br />

SON PLC<br />

INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

SOLUTION FOR<br />

INJECTION<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

OROMUCOSAL<br />

SOLUTION<br />

N/A WILLIAM RANSOM &<br />

SON PLC<br />

COMTAN FILM COATED TABLETS 200MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

COMTAN FILM COATED TABLETS 200MG NOVARTIS EUROPHARM<br />

LIMITED<br />

COMTAN FILM-COATED TABLETS 200MG NOVARTIS EUROPHARM<br />

LIMITED<br />

CONCAVIT SOFT GELATINE<br />

CAPSULES<br />

N/A WALLACE<br />

MANUFACTURING<br />

CHEMISTS LIMITED<br />

CONCAVIT DROPS N/A WALLACE<br />

MANUFACTURING<br />

CHEMISTS LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

UNITED KINGDOM<br />

GERMANY<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

516 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CONDYLINE SOLUTION 5MG/ML YAMANOUCHI PHARMA<br />

B.V.<br />

CONOTRANE CREAM N/A YAMANOUCHI PHARMA<br />

LIMITED<br />

CONTAC 12 CAPSULE 50MG MENLEY & JAMES<br />

LIMITED<br />

CONTAC 400 CAPSULES GASTRO-RESISTANT<br />

GRANULES<br />

N/A MENLEY & JAMES LTD<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCAR<br />

NETHERLANDS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CONTACT ADMINISTRATOR XXX XXX GERMANY<br />

CONTRACIDE ORAL SUSPENSION N/A LABORATOIRES<br />

NORGINE PHARMA<br />

CONTRACIDE ORAL SUSPENSION N/A LABORATOIRES<br />

NORGINE PHARMA<br />

FRANCE<br />

FRANCE<br />

CONTRATUBEX GEL N/A MERZ+CO. GMBH & CO. GERMANY<br />

COOL MINT LISTERINE SOLUTION N/A WARNER-LAMBERT S.A.<br />

(PTY) LTD<br />

SOUTH AFRICA<br />

CO-PROXAMOL TABLETS COATED TABLET N/A SANOFI WINTHROP LTD UNITED KINGDOM<br />

CO-PROXAMOL TABLETS BP TABLET N/A M & A PHARMACHEM<br />

LIMITED<br />

CORACTEN RETARD CAPSULE 20MG SMITHKLINE BEECHAM<br />

PHARMA GMBH<br />

UNITED KINGDOM<br />

GERMANY<br />

CORADAY MR 20MG TABLET TABLET 20MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

CORDARONE 150MG/3ML IV INJECTABLE<br />

SOLUTION<br />

150MG/3ML SANOFI WINTHROP FRANCE<br />

CORDARONE 200MG SCORED TABLET 200MG SANOFI WINTHROP FRANCE<br />

CORDARONE X/AMIODARONE<br />

HCL 100MG TABLETS<br />

TABLET 100MG SANOFI WINTHROP<br />

LIMITED<br />

UNITED KINGDOM<br />

CORDICANT CAPSULES 5MG MUNDIPHARMA GMBH GERMANY<br />

CORDICANT CAPSULE 10MG MUNDIPHARMA GMBH GERMANY<br />

CORDICANT RETARD TABLETS 20MG MUNDIPHARMA GMBH GERMANY<br />

CORDICANT RETARD PROLONGED RELEASE<br />

TABLETS<br />

20MG MUNDIPHARMA GMBH GERMANY<br />

CORDILOX SR TABLETS 240MG NORTON HEALTHCARE<br />

LTD<br />

CORDIMEDIL FILM COATED TABLETS 300MG KLEVA LIMITED GREECE<br />

UNITED KINGDOM<br />

CORGARD TABLETS 40MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

CORGARD TABLETS 80MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

CORGARETIC 40MG/5MG TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

CORGARETIC 80MG/5MG TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

CORICIDIN-D EXTRA STRENGTH TABLETS N/A S-P CANADA CANADA<br />

CORITUSSAL CAPSULES N/A HEINRICH MACK NACHF GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 517<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CORITUSSAL SYRUP SUSPENSION N/A HEINRICH MACK NACHF GERMANY<br />

CORN REMOVAL PLASTERS PLASTER 40%W/W SCHOLL CONSUMER<br />

PRODUCTS<br />

CORN REMOVAPADS PLASTER 40%W/W SCHOLL CONSUMER<br />

PRODUCTS<br />

CORPRILOR TABLETS 20MG LABORATORIOS RUBIO<br />

S.A<br />

CORSODYL DENTAL GEL 1% W/W DENTAL GEL 1% W/W BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

CORSODYL MINT MOUTHWASH<br />

0.2% W/V<br />

CORSODYL MOUTHWASH 0.2%<br />

W/V<br />

DENTAL SOLUTION 0.2% W/V BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

DENTAL SOLUTION 0.2% W/V BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

CORTEF TABLETS 10MG PHARMACIA & UPJOHN<br />

COMPANY<br />

CORTEF HYDROCORTISONE<br />

TABLETS<br />

TABLETS 20MG PHARMACIA AND<br />

UPJOHN COMPANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SPAIN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

CORTIFOAM RECTAL FOAM N/A SCHWARZ PHARMA INC. UNITED STATES OF<br />

AMERICA<br />

CORTISONE ACETATE TABLET 25MG REKAH<br />

PHARMACEUTICAL<br />

INDUSTRY LTD<br />

CORTODERM ONT 1% W/W OINTMENT 1% W/W TARO<br />

PHARMACEUTICALS INC.<br />

CORTOPIN HYDROCORTISONE<br />

CREAM<br />

CORTOPIN HYDROCORTISONE<br />

CREAM<br />

CORTOPIN HYDROCORTISONE<br />

OINTMENT<br />

CREAM 1% W/W PINEWOOD<br />

LABORATORIES LIMITED<br />

CREAM 1% W/W PINEWOOD<br />

LABORATORIES LTD T/A<br />

PINEWOOD<br />

HEALTHCARE<br />

OINTMENT 1% W/W PINEWOOD<br />

LABORATORIES LTD T/A<br />

PINEWOOD<br />

HEALTHCARE<br />

CORVASAL 2MG TABLET 2MG LABORATOIRES<br />

HOECHST<br />

CORVASAL 4MG TABLET 4MG LABORATOIRES<br />

HOECHST<br />

COSOPT EYEDROPS N/A MERCK SHARP AND<br />

DOHME LIMITED<br />

ISRAEL<br />

CANADA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

COSTI 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS<br />

CO-TENIDONE TABLETS 100MG/25MG NORTON HEALTHCARE<br />

LIMITED<br />

CO-TENIDONE TABLETS 50MG/12.5MG NORTON HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

518 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

COTRIM SUSPENSION N/A MEDOCHEMIE LTD CYPRUS<br />

COTRIM 480MG TABLET N/A MEDOCHEMIE LTD CYPRUS<br />

COTRIM D.S. TABLET N/A MEDOCHEMIE LTD CYPRUS<br />

COTRIMHEXAL FORTE TABLET N/A HEXAL AG GERMANY<br />

CO-TRIMOXAZOLE TABLETS 960MG PHARMAMED LTD. MALTA<br />

CO-TRIMOXAZOLE TABLETS 960MG PHARMAMED LTD. MALTA<br />

CO-TRIMOXAZOLE TABLETS N/A MACLEODS INDIA<br />

CO-TRIMOXAZOLE BP 400/80MG TABLET N/A SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

COTRIMOXAZOLE TABLETS<br />

B.P.480MG<br />

UNCOATED TABLET N/A MEDICORP<br />

TECHNOLOGIES INDIA<br />

LTD.,<br />

UNITED KINGDOM<br />

COUMADIN TABLETS 1MG DUPONT PHARMA UNITED STATES OF<br />

AMERICA<br />

COUMADIN TABLETS 2.5MG DUPONT PHARMA UNITED STATES OF<br />

AMERICA<br />

COUMADIN TABLETS 5MG DUPONT PHARMA UNITED STATES OF<br />

AMERICA<br />

COUMADIN TABLETS 2MG DUPONT<br />

PHARMACEUTICALS<br />

COMPANY (DUPONT<br />

PHARMA)<br />

COUMADIN TABLETS 3MG DUPONT<br />

PHARMACEUTICALS<br />

COMPANY<br />

COUMADIN TABLETS 6MG DUPONT<br />

PHARMACEUTICALS<br />

COMPANY<br />

COUMADIN TABLETS 4MG DUPONT<br />

PHARMACEUTICALS<br />

COMPANY<br />

COUMADIN TABLETS 7.5MG DUPONT<br />

PHARMACEUTICALS<br />

COMPANY<br />

COUMADIN TABLETS 10MG DUPONT<br />

PHARMACEUTICALS<br />

COMPANY<br />

INDIA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

COVERSYL TABLET 4MG SERVIER PAKISTAN<br />

COVERSYL TABLETS 4MG LES LABORATOIRES<br />

SERVIER<br />

COVERSYL 2MG TABLET 2MG LES LABORATOIRES<br />

SERVIER<br />

FRANCE<br />

FRANCE<br />

COVONIA BRONCHIAL BALSAM ORAL SOLUTION N/A THORNTON & ROSS LTD UNITED KINGDOM<br />

COVONIA MENTHOLATED<br />

COUGH MIXTURE<br />

ORAL SOLUTION N/A LCM LTD UNITED KINGDOM<br />

COVONIA NIGHT TIME FORMULA ORAL SOLUTION N/A THORNTON & ROSS UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 519<br />

Trade Name Dosage Form Dose MA Holder Country<br />

COXERIN CAPSULES 250MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

COZAAR TABLET 100MG MERCK SHARP AND<br />

DOHME LIMITED<br />

COZAAR 50MG TABLET 50MG MERCK SHARP & DOHME<br />

B.V.<br />

INDIA<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

COZAAR TABLETS TABLETS 50MG MSD PAKISTAN<br />

CRAMPEX TABLETS TABLET N/A SETON PRODUCTS<br />

LIMITED<br />

CREON 10 000 CAPSULE 150MG SOLVAY ARZNEIMITTEL<br />

GMBH<br />

CREON 25 000 CAPSULE 300MG SOLVAY ARZNEIMITTEL<br />

GMBH<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

CRIXIVAN HARD CAPSULE 400MG MERCK SHARP & DOHME UNITED KINGDOM<br />

CROMABAK EYEDROPS 2% N/A LABORATOIRES THEA FRANCE<br />

CROMAL EYE DROPS 2%W/V CIPLA LTD INDIA<br />

CROMAL-5 INHALER N/A CIPLA LIMITED INDIA<br />

CROMOGEN INHALER 5MG NORTON HEALTHCARE<br />

LIMITED<br />

CROMOGEN EASI BREATHE<br />

INHALER<br />

CROMOGEN STERI-NEB SOLUTION FOR<br />

NEBULISATION<br />

INHALER 5MG NORTON HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

20MG/2ML STERIPAK LIMITED UNITED KINGDOM<br />

CRYSTACIDE CREAM 1% CREAM 1% W/ W BIOGLAN<br />

LABORATORIES LTD<br />

CUATRODERM CREAM N/A SCHERING PLOUGH S.A. SPAIN<br />

CUPAL HONEY AND LEMON<br />

MELTUS COUGH LINCTUS<br />

UNITED KINGDOM<br />

ORAL SOLUTION 50MG/5ML CUPAL LTD UNITED KINGDOM<br />

CUPROFEN COATED TABLETS 400 MG CUPAL LIMITED UNITED KINGDOM<br />

CUPROFEN IBUPROFEN COATED TABLETS 200 MG CUPAL LIMITED UNITED KINGDOM<br />

CURAM TABLET N/A BIOCHEMIE GMBH AUSTRIA<br />

CURZON TABLETS TABLET N/A CATHAY OF<br />

BOURNEMOUTH LTD T/A<br />

GERARD HOUSE<br />

CUSIMOLOL 0.25% EYE DROPS 0.25% W/V ALCON CUSI, S.A. SPAIN<br />

CUSIMOLOL 0.5% EYE DROPS 0.5% W/V ALCON CUSI, S.A. SPAIN<br />

CUSIMOLOL 0.5% EYE DROPS 0.5% W/V LABORATORIOS CUSI<br />

S.A.<br />

CUTIVATE CREAM CREAM 0.05%W/W GLAXO WELLCOME UK<br />

LIMITED T/A GLAXO<br />

LABORATORIES<br />

CUTIVATE CREAM 0.05% CREAM 0.05% W/W GLAXO WELLCOME UK<br />

LTD<br />

UNITED KINGDOM<br />

SPAIN<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

520 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CUTIVATE OINTMENT OINTMENT 0.05%W/W GLAXO WELLCOME UK<br />

LIMITED T/A GLAXO<br />

LABORATORIES<br />

CUTIVATE OINTMENT 0.005% OINTMENT 0.005% GLAXO WELLCOME UK<br />

LTD<br />

CYCLIMORPH 10 SOLUTION FOR<br />

INJECTION<br />

CYCLIMORPH 15 SOLUTION FOR<br />

INJECTION<br />

N/A WELLCOME<br />

FOUNDATION LTD.<br />

N/A WELLCOME<br />

FOUNDATION LTD.<br />

CYCLOGYL 0.5% OPHTHALMIC SOLUTION 0.5% W/V S.A. ALCON-COUVREUR<br />

N.V.<br />

CYCLOSPORINE (IMUSPORIN-100) CAPSULES 100MG CIPLA LIMITED INDIA<br />

CYCLOSPORINE (IMUSPORIN-25) SOFT GELATIN CAPSULES 25MG CIPLA LIMITED INDIA<br />

CYCLOSPORINE (IMUSPORIN-50) SOFT GELATIN CAPSULE 50MG CIPLA LIMITED INDIA<br />

CYKLOKAPRON SOLUTION FOR<br />

INJECTION<br />

100MG/ML PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

CYKLOKAPRON TABLETS 500MG PHARMACIA & UPJOHN<br />

SVERIGE SA<br />

CYKLOKAPRON SOLUTION FOR<br />

INJECTION<br />

CYKLOKAPRON SOLUTION F/<br />

PARENTERAL USE<br />

CYKLOKAPRON SOL. FOR PARENTERAL<br />

USE<br />

CYKLOKAPRON SOL. FOR PARENTERAL<br />

USE<br />

CYMALON GRANULES FOR ORAL<br />

SOLN.<br />

CYMALON GRANULES FOR ORAL<br />

SUSPE.<br />

100MG/ML PHARMACIA & UPJOHN<br />

N.V./S.A.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

BELGIUM<br />

SWEDEN<br />

ITALY<br />

BELGIUM<br />

100MG/ML PHARMACIA NV/SA BELGIUM<br />

100MG/ML PHARMACIA NV/SA BELGIUM<br />

100MG/ML PHARMACIA NV/SA BELGIUM<br />

N/A SETON PRODUCTS<br />

LIMITED<br />

N/A SETON PRODUCTS<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CYMEX CREAM CREAM N/A PL 00083/0026 UNITED KINGDOM<br />

CYNT 0.2 FILM-COATED TABLET 0.2MG BEIERSDORF-LILLY GMBH GERMANY<br />

CYNT 0.3 FILM-COATED TABLET 0.3MG BEIERSDORF-LILLY GMBH GERMANY<br />

CYNT 0.4 FILM-COATED TABLET 0.4MG BEIERSDORF-LILLY GMBH GERMANY<br />

CYPROCUR TABLETS 50 MG CIPLA LTD — INDIA INDIA<br />

CYPROTERONE ACETATE TABLETS 50 MG GENERICS (UK) LIMITED<br />

—UK<br />

CYPROTERONE ACETATE TABLETS 50MG CP PHARMACEUTICALS<br />

LIMITED<br />

CYSTOCALM GRANULES FOR ORAL<br />

SOL.<br />

CYSTOFEM CYSTITIS RELIEF<br />

GRANULES<br />

4G GALPHARM<br />

HEALTHCARE LIMITED<br />

GRANULES N/A SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

CYSTRIN 5MG TABLET 5MG LEIRAS OY FINLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 521<br />

Trade Name Dosage Form Dose MA Holder Country<br />

CYTARABINE INJECTION VIAL SOLUTION FOR<br />

INJECTION<br />

CYTOBLASTIN AQUEOUS SOLUTION FOR<br />

INJECTION<br />

CYTOCRISTIN AQUEOUS SOLUTION FOR<br />

INJECTION<br />

100MG/5ML F.H. FAULDING & CO.<br />

LTD (T/A DAVID BULL<br />

LABS)<br />

10MG/ML CIPLA LIMITED INDIA<br />

1MG/1ML CIPLA LIMITED INDIA<br />

CYTODROX CAPSULES 500MG CIPLA LTD INDIA<br />

CYTOPLATIN-10 AQUEOUS SOLUTION FOR<br />

INJECTION<br />

CYTOPLATIN-50 AQUEOUS SOLUTION FOR<br />

INJECTION<br />

10MG/20ML CIPLA LIMITED INDIA<br />

50MG/50ML CIPLA LIMITED INDIA<br />

CYTOSAR POWDER FOR INJECTION 100MG/VIAL PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

CYTOSAR POWDER FOR INJECTION 500MG PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

CYTOTAM-20 TABLETS 20MG CIPLA LTD INDIA<br />

UNITED KINGDOM<br />

BELGIUM<br />

BELGIUM<br />

CYTOTEC TABLETS 200MCG MONSANTO PLC UNITED KINGDOM<br />

CYTOTEC TABLETS 200MCG MONSANTO PLC T/A<br />

SEARLE<br />

CYTOTEC TABLETS 200MCG MONSANTO PLC T/A<br />

SEARLE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CYTOTEC 200 MCG TABLETS TABLETS 200 MCG PHARMACIA LIMITED UNITED KINGDOM<br />

CYTOTREX TABLETS 2.5MG CIPLA LTD. INDIA<br />

CZARTAN TABLET 25MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

D.D.D. MEDICATED LOTION TOPICAL SOLUTION N/A D D D LIMITED UNITED KINGDOM<br />

D.T. COQ INJECTABLE SUSPENSION N/A (IN PFS) PASTEUR MERIEUX FRANCE<br />

D.T. POLIO VACCINE VACCINE N/A PASTEUR MERIEUX FRANCE<br />

D.T. VAX INJECTABLE<br />

PREPARATION<br />

INDIA<br />

N/A PASTEUR MERIEUX FRANCE<br />

DACARBAZINE FOR INJECTION POWDER FOR INJECTION 20MG/ML FAULDING<br />

PHARMACEUTICALS PLC<br />

DADCROME EYE DROPS 220MG/10ML DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

UNITED KINGDOM<br />

JORDAN<br />

DAFLON TABLET 150MG SERVIER PAKISTAN<br />

DAFLON 500MG TABLET LES LABORATOIRES<br />

SERVIER<br />

DAFLON 375MG COATED TABLET 375MG LES LABORATOIRES<br />

SERVIER<br />

FRANCE<br />

FRANCE<br />

DAFLON 500MG COATED TABLET 500MG LABORATOIRES SERVIER FRANCE<br />

DAIVONEX CREAM 50MCG/G LEO PHARMACEUTICAL<br />

PRODUCTS LIMITED<br />

DENMARK


EN<br />

522 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DAIVONEX SCALP SOLUTION 50MCG/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

DAIVONEX OINTMENT 50MCG/G LEO PHARMACEUTICAL<br />

PRODUCTS<br />

DENMARK<br />

DENMARK<br />

DAKTACORT CREAM N/A JANSSEN-CILAG N.V. BELGIUM<br />

DAKTACORT CREAM N/A JANSSEN PAKISTAN<br />

DAKTARIN CREAM 20MG/G JANSSEN-CILAG N.V. BELGIUM<br />

DAKTARIN LOTION 20MG/G JANSSEN-CILAG N.V. BELGIUM<br />

DAKTARIN LOTION 20MG/G JANSSEN FARMACEUTICA<br />

PORTUGAL<br />

DAKTARIN CUTANEOUS SOLUTION 20MG/ML JANSSEN FARMACEUTICA<br />

PORTUGAL<br />

PORTUGAL<br />

PORTUGAL<br />

DAKTARIN 2% ORAL GEL 2% W/W JANSSEN-CILAG N.V. BELGIUM<br />

DAKTARIN 2% TINCTURE 2% W/V JANSSEN-CILAG N.V. BELGIUM<br />

DAKTARIN 2% POWDER 20MG/G JANSSEN-CILAG N.V. BELGIUM<br />

DALACIN TOPICAL SOLUTION 10MG/ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

BELGIUM<br />

DALACIN VAGINAL CREAM 2%W/W PHARMACIA LIMITED UNITED KINGDOM<br />

DALACIN C CAPSULE 150MG UPJOHN PAKISTAN<br />

DALACIN C SOLUTION FOR<br />

INJECTION<br />

DALACIN C SOLUTION FOR<br />

INJECTION<br />

300MG/2ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

600MG/4ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

BELGIUM<br />

BELGIUM<br />

DALACIN C ORAL CAPSULES 150MG PHARMACIA NV/AS BELGIUM<br />

DALACIN C 150MG ORAL CAPSULES 150MG PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

DALACIN C 75MG ORAL CAPSULES 75MG PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

DALACIN C 75MG/5ML SYRUP 75MG/5ML PHARMACIA & UPJOHN<br />

N.V./ S.A<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

DALACIN T LOTION N/A UPJOHN PAKISTAN<br />

DALACIN T TOPICAL SOLUTION 10MG/1ML PHARMACIA NV/AS BELGIUM<br />

DALACIN VAGINAL OVULES VAGINAL OVULES 100MG PHARMACIA & UPJOHN<br />

COMPANY<br />

DALIVIT DROPS ORAL EMULSION N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

DALMANE CAPSULES CAPSULES 15MG ICN PHARMACEUTICALS<br />

LIMITED<br />

DALMANE CAPSULES CAPSULES 30MG ICN PHARMACEUTICALS<br />

LIMITED<br />

DANATROL 200MG CAPSULE 200MG SANOFI WINTHROP FRANCE<br />

DANOGEN-200 CAPSULES 200MG CIPLA LTD. INDIA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 523<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DANOL 200MG CAPSULES CAPSULE 200MG SANOFI WINTHROP<br />

LIMITED<br />

UNITED KINGDOM<br />

DAONIL TABLET 5MG HOECHST PAKISTAN<br />

DAONIL TABLET 5MG HOECHST MARION<br />

ROUSSEL<br />

DAONIL 5MG TABLET 5MG LABORATOIRES<br />

HOECHST<br />

DAONIL FAIBLE 1.25MG TABLET 1.25MG LABORATOIRES<br />

HOECHST<br />

DAPA-TABS TABLETS 2.5MG ALPHAPHARM PTY<br />

LIMITED<br />

PAKISTAN<br />

FRANCE<br />

FRANCE<br />

AUSTRALIA<br />

DAPRIL 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS<br />

DAPRIL 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS<br />

DAPRIL 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

DARAPRIM TABLETS 25MG WELLCOME<br />

FOUNDATION LTD.<br />

DARAZIO TABLETS NA DELTA HF ICELAND<br />

DAREN TABLETS 2.5MG DELTA HF ICELAND<br />

DAREN TABLETS 5MG DELTA HF ICELAND<br />

DAREN TABLETS 10MG DELTA HF ICELAND<br />

DAREN TABLETS 20MG DELTA HF ICELAND<br />

DAUNOBLASTINA POWDER FOR INJECTION 20MG/VIAL PHARMACIA & UPJOHN<br />

S.P.A.<br />

DAUNOBLASTINA POWDER FOR SOLN FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

ITALY<br />

20MG/10ML PHARMACIA ITALIA S.P.A ITALY<br />

DAY NURSE ORAL SOLUTION NA BEECHAM GROUP PLC<br />

T/A GLAXOSMITHKLINE<br />

CONSUMER<br />

HEALTHCARE<br />

DAY NURSE HARD CAPSULES NA BEECHAM GROUP PLC<br />

T/A GLAXOSMITHKLINE<br />

CONSUMER<br />

HEALTHCARE<br />

DAY NURSE CAPSULES CAPSULE N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

DAY NURSE CAPSULES CAPSULE N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

DAYTIME COLD AND FLU LIQUID<br />

CAPSULES<br />

CAPSULE N/A STANLEY<br />

PHARMACEUTICALS LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CANADA<br />

DAZIL 30 TABLETS 30MG AEGIS LTD. CYPRUS<br />

DAZIL 60 TABLETS 60MG AEGIS LTD. CYPRUS<br />

DAZIL 90 TABLETS 90MG AEGIS LTD CYPRUS


EN<br />

524 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DBL CARBOPLATIN INJECTION<br />

VIAL<br />

SOLUTION FOR<br />

INJECTION<br />

DBL CISPLATIN INJECTION VIAL SOLUTION FOR<br />

INJECTION<br />

DBL DAUNORUBICIN 20MG/4ML SOLUTION FOR<br />

INJECTION<br />

DBL HYOSCINE HYDROBROMIDE SOLUTION FOR<br />

INJECTION<br />

DBL METHOTREXATE INJECTION<br />

VIAL<br />

SOLUTION FOR<br />

INJECTION<br />

DBL MORPHINE SULPHATE SOLUTION FOR<br />

INJECTION<br />

DBL MORPHINE SULPHATE SOLUTION FOR<br />

INJECTION<br />

DBL PETHIDINE HYDROCHLORIDE SOLUTION FOR<br />

INJECTION<br />

150MG/15ML F.H. FAULDING & CO LTD<br />

(T/A DAVID BULL LABS)<br />

50MG/50ML F.H. FAULDING & CO LTD<br />

(T/A DAVID BULL LABS)<br />

AUSTRALIA<br />

AUSTRALIA<br />

20MG/4ML F.H. FAULDING & CO LTD AUSTRALIA<br />

400MCG F.H FAULDING & CO.<br />

LIMITED T/A DAVID<br />

BULL LABORATORIES<br />

50MG/2ML F.H. FAULDING & CO LTD<br />

(T/A DAVID BULL LABS)<br />

AUSTRALIA<br />

AUSTRALIA<br />

10MG/ML F.H. FAULDING & CO LTD AUSTRALIA<br />

15MG/1ML F.H. FAULDING & CO LTD AUSTRALIA<br />

50MG/ML F.H. FAULDING & CO LTD AUSTRALIA<br />

DDAVP INTRANASAL SOL. NASAL DROPS 0.01% FERRING<br />

PHARMACEUTICALS<br />

LIMITED<br />

DDAVP TABLETS TABLET 0.1MG FERRING<br />

PHARMACEUTICALS LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

DDD MEDICATED LOTION TOPICAL SOLUTION NA DDD LIMITED UNITED KINGDOM<br />

DE WITTS ANTACID TABLETS TABLET N/A E C DE WITT & CO LTD UNITED KINGDOM<br />

DE WITTS THROAT LOZENGES LOZENGE N/A E C DE WITT & CO LTD UNITED KINGDOM<br />

DEANXIT SUGAR-COATED TABLET N/A LUNDBECK<br />

ARZNEIMITTEL<br />

GESELLSCHAFT M.B.H.<br />

DECADRON 4MG/ML INJECTION FLUID 4MG/ML MERCK SHARP & DOHME<br />

B.V.<br />

DECADRON EAR + NEOMYCIN<br />

0.1% DPS<br />

DECADRON EYE + NEOMYCIN<br />

0.1% DPS<br />

DECA-DURABOLIN SOLUTION FOR<br />

INJECTION<br />

DECA-DURABOLIN 25MG/ML SOLUTION FOR<br />

INJECTION<br />

DECA-DURABOLIN 50MG/ML<br />

INJECTION<br />

EAR DROPS N/A MERCK SHARP & DOHME<br />

B.V.<br />

EYE DROPS N/A MERCK SHARP & DOHME<br />

B.V.<br />

SOLUTION FOR<br />

INJECTION<br />

DECAPEPTYL 0.1MG POWDER FOR INJEC.<br />

SUSPEN.<br />

25MG/ML ORGANON<br />

LABORATORIES<br />

25MG/ML ORGANON<br />

LABORATORIES LIMITED<br />

50MG/ML ORGANON<br />

LABORATORIES LIMITED<br />

0.1MG LABORATOIRES IPSEN<br />

BIOTECH<br />

DECAVIT CAPSULE N/A ROWA<br />

PHARMACEUTICALS LTD<br />

DECLOVIR CREAM 5% W/W HOE PHARMACEUTICALS<br />

SDN.BHD.<br />

DECLOVIR CREAM CREAM 5% W/W HOE PHARMACEUTICALS<br />

SDN. BHD<br />

AUSTRIA<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

IRELAND<br />

MALAYSIA<br />

MALAYSIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 525<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DECOCORT CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

DECOCORT CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

DECOCORT CREAM CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD<br />

DECONGESTANT NASAL SPRAY<br />

0.1% W/V<br />

AEROSOL 0.1% W/V STANLEY<br />

PHARMACEUTICALS LTD<br />

DECOZOL CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD<br />

DECOZOL CREAM 2% W/W HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

CANADA<br />

MALAYSIA<br />

MALAYSIA<br />

DECUTAN SOFT GELATIN CAPSULES 10MG DELTA LIMITED ICELAND<br />

DECUTAN SOFT GELATIN CAPSULES 20MG DELTA LIMITED ICELAND<br />

DEEP FREEZE AEROSOL SPRAY TOPICAL SPRAY N/A THE MENTHOLATUM<br />

COMPANY LIMITED<br />

DEEP HEAT MAXIMUM STRENGTH<br />

CREAM<br />

CREAM N/A THE MENTHOLATUM<br />

COMPANY LIMITED<br />

DEEP RELIEF GEL N/A THE MENTHOLATUM<br />

COMPANY LIMITED<br />

DEFAROL TABLET 10MG PROEL S.A. CORONIS E.G. GREECE<br />

DEFFERINE GEL 0.1% W/W LABORATOIRE<br />

GALDERMA<br />

DEHYDRATED ALCOHOL BP FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

100%V/V MACARTHYS<br />

LABORATORIES LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

DEHYDROBENZPERIDOL AMPOULE 2.5MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

DELIMON GEL FOR EXTERNAL USE 11.6MG/1G PHARMATHEN LTD. GREECE<br />

DELTACOTRIL ENTERIC COATED<br />

TABLET<br />

UNITED KINGDOM<br />

2.5MG PFIZER LIMITED UNITED KINGDOM<br />

DEMOCINETIC CREAM N/A GEYMONAT SPA ITALY<br />

DENAVIR 1% (VECTAVIR) CREAM 1% W/W LABORATOIRES<br />

SMITHKLINE BEECHAM<br />

FRANCE<br />

DENEREL 0.2MG/ML SYRUP 0.2MG/ML MEDOCHEMIE LTD CYPRUS<br />

DENEREL 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS<br />

DENEX TABLET 100MG MEDOCHEMIE LTD CYPRUS<br />

DE-NOL TABLETS 120MG YAMANOUCHI PHARMA<br />

B.V.<br />

DENTINOX CRADLE CAP<br />

TREATMENT SHAMPOO<br />

NETHERLANDS<br />

SHAMPOO N/A D D D LIMITED UNITED KINGDOM<br />

DENTINOX INFANT COLIC DROPS ORAL SUSPENSION N/A D D D LIMITED UNITED KINGDOM<br />

DENTINOX TEETHING GEL DENTAL GEL N/A D D D LIMITED UNITED KINGDOM<br />

DEPACON SOLUTION FOR<br />

INJECTION<br />

500MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA


EN<br />

526 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DEPAKINE 400MG/4ML FREEZE-DRIED POWDER 400MG/4ML SANOFI-SYNTHELABO<br />

FRANCE<br />

DEPAKOTE DELAYED RELEASE<br />

TABLETS<br />

DEPO-MEDROL STERILE AQ. SUSP. FOR<br />

INJ<br />

DEPO-MEDROL STERILE AQ. SUSP. FOR<br />

INJ<br />

DEPO-PROVERA STERILE AQ. SUSP. FOR<br />

INJ<br />

DEPO-PROVERA STERILE AQ. SUSP. FOR<br />

INJ<br />

DEPO-PROVERA STERILE AQUEOUS<br />

SUSPENS.<br />

FRANCE<br />

500MG ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

40MG/ML PHARMACIA & UPJOHN<br />

N.V./ S.A<br />

80MG/2ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

500MG/VIAL PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

1000MG/VIAL PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

150MG/ML PHARMACIA N.V./S.A. BELGIUM<br />

DEPRIM TABLETS N/A REMEDICA LTD CYPRUS<br />

DEQUACAINE LOZENGE N/A CROOKES HEALTHCARE<br />

LIMITED<br />

DEQUADIN LOZENGE 0.25MG CROOKES HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

DERM-AID CREAM 5MG/G EGO PHARMACEUTICALS AUSTRALIA<br />

DERMAID SOFT 0.5% CREAM CREAM 0.5% EGO PHARMACEUTICALS<br />

PTY LTD.<br />

DERMAID SOFT 1% CREAM CREAM 1% EGO PHARMACEUTICALS<br />

PTY LTD.<br />

AUSTRALIA<br />

AUSTRALIA<br />

DERMATIN SHAMPOO 20MG/ML DELTA HF ICELAND<br />

DERMESONE CREAM N/A DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

DERMESONE SKIN OINTMENT 1MG/G DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD<br />

DERMIDEX DERMATOLOGICAL<br />

CREAM<br />

DERMOBACTER SOLN FOR CUTANEOUS<br />

APPLIC<br />

JORDAN<br />

JORDAN<br />

CREAM N/A PHARMALAB LTD UNITED KINGDOM<br />

N/A INNOTECH<br />

INTERNATIONAL<br />

DERMOCINETIC CREAM N/A GEYMONAT SPA ITALY<br />

DERMOVATE CREAM CREAM 0.053% W/W GLAXO WELLCOME UK<br />

LTD T/A GLAXO LABSS<br />

DERMOVATE CREAM CREAM 0.05%W/W GLAXO WELLCOME UK<br />

LIMITED<br />

DERMOVATE OINTMENT OINTMENT 0.05% W/W GLAXO WELLCOME UK<br />

LTD<br />

DERMOVATE OINTMENT OINTMENT 0.05%W/W GLAXO WELLCOME UK<br />

LIMITED<br />

DERMOVATE SCALP<br />

APPLICATION<br />

DERMOVATE SCALP<br />

APPLICATION<br />

SOLUTION FOR TOPICAL<br />

USE<br />

0.5MG/G GLAXO WELLCOME<br />

GMBH & CO<br />

TOPICAL SOLUTION 0.05%W/W GLAXO WELLCOME UK<br />

LIMITED<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 527<br />

DERMOVATE SCALP<br />

APPLICATION 0.05%<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SOLTN. FOR SCALP APPL. 0.05% W/W GLAXO WELLCOME<br />

GMBH & CO<br />

DESAL 40MG 50 TABLET TABLET 40MG BIOFARMA ILAC SAN. VE<br />

TIC.A.S.<br />

DESFERAL SUBSTANCE FOR<br />

INJECTION<br />

DESFERAL DRY SUBSTANCE FOR<br />

INJ.<br />

DESFERAL SOLUTION FOR<br />

INJECTION<br />

DE-SPASM 135MG FILM COATED<br />

TABLETS<br />

DETACORTIL ENTERIC COATED<br />

TABLET<br />

500MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

500MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

500MG NOVARTIS PHARMA<br />

GMBH<br />

FILM COATED TABLETS 135MG ELSAAD PHARMA —<br />

SYRIA<br />

GERMANY<br />

TURKEY<br />

SWITZERLAND<br />

SWITZERLAND<br />

GERMANY<br />

SYRIA<br />

5MG PFIZER LIMITED UNITED KINGDOM<br />

DETADERM NM CREAM NA ATCO LABORATORIES<br />

(PVT) LTD<br />

DETIMEDAC POWDER F/SOLN FOR IV<br />

INJ<br />

200MG/VIAL GESELLSCHAFT FUR<br />

KLINISCHE<br />

SPEZIALPREPARATE MBH<br />

DETRUSITOL FILM COATED TABLET 1MG PHARMACIA & UPJOHN<br />

S.P.A.<br />

DETRUSITOL FILM COATED TABLET 2MG PHARMACIA & UPJOHN<br />

S.P.A.<br />

DETRUSITOL FILM-COATED TABLETS 1MG PHARMACIA ITALIA SPA ITALY<br />

DETRUSITOL FILM-COATED TABLETS 2MG PHARMACIA ITALIA SPA ITALY<br />

DETTOL ANTISEPTIC CREAM CREAM N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

DEXA RHINASPRAY N NASAL SPRAY SOLUTION N/A BOEHRINGER INGELHEIM<br />

ELLAS A.E<br />

DEXA-GENTAMICIN EYE OINTMENT N/A URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

DEXA-GENTAMICIN EYE DROPS N/A URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

PAKISTAN<br />

GERMANY<br />

ITALY<br />

ITALY<br />

UNITED KINGDOM<br />

GREECE<br />

GERMANY<br />

GERMANY<br />

DEXAMED 0.5MG TABLET 0.5MG MEDOCHEMIE LTD CYPRUS<br />

DEXAMED 1.5MG TABLET 1.5MG MEDOCHEMIE LTD CYPRUS<br />

DEXAMED 8MG/2ML LIQUID FOR INJECTION 8MG/2ML MEDOCHEMIE LTD CYPRUS<br />

DEXAMETHASONE PHOSPHATE<br />

INJECTION<br />

DEXAMETHASONE SODIUM<br />

PHOSPHATE<br />

DEXAMETHASONE SODIUM<br />

PHOSPHATE<br />

SOLUTION FOR<br />

INJECTION<br />

8MG/2ML F.H. FAULDING & CO.<br />

LTD (T/A DAVID BULL<br />

LABS)<br />

SOL. FOR INJ. 8MG/2ML EGYPTIAN<br />

INTERNATIONAL<br />

PHARMACEUTICAL<br />

INDUSTRIES CO.<br />

SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

EGYPT<br />

4MG/ML CIPLA LTD INDIA<br />

DEXAMETHASONE/GAP INJECTABLE SOLUTION 8MG/2ML GAP S.A. GREECE


EN<br />

528 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DEXAMYTREX EYE DROPS EYE DROPS N/A DR.GERHARD MANN,<br />

CHEM.-PHARM. FABRIK<br />

GMBH<br />

DEXAMYTREX EYE OINTMENT EYE OINTMENT N/A DR. GERHARD MANN,<br />

CHEM.-PHARM. FABRIK<br />

GMBH<br />

DEXA-RHINOSPRAY PUMP SPRAY N/A BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

DEXTRAN 40 10% W/V IN<br />

DEXTROSE 5% W/V<br />

DEXTRAN 40 10% W/V IN NACL<br />

0.9% W/V<br />

DEXTRAN 40 IV INFUSION IN<br />

SODIUM CHLOR.<br />

DEXTRAN 70 6% W/V IN<br />

DEXTROSE 5% W/V<br />

DEXTRAN 70 6%W/V IN NACL<br />

0.9%W/V<br />

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

SOLUTION FOR<br />

INJECTION<br />

DEXTROSE SOLUTION FOR<br />

INJECTION<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

10% W/V BP GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

DEXTROSE 10% W/V SOL. FOR INJ./INF. 10% W/V PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

DEXTROSE 20% W/V SOL. FOR INJ./INF. 20%W/V PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

DEXTROSE 3.33% W/V IN NACL<br />

0.3% W/V<br />

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

DEXTROSE 30% W/V SOL. FOR INJ./INF. 30%W/V PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

DEXTROSE 4% W/V IN NACL<br />

0.18% W/V<br />

SOL. FOR INJ./INF N/A PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

DEXTROSE 5% (W/V) SOL. FOR INJ./INFUSION 5%W/V PARACELCIA INDUSTRIA<br />

FARMACEUTICA SA<br />

DEXTROSE 5% W/V IN NACL 0.3%<br />

W/V<br />

DEXTROSE 5% W/V IN NACL 0.9%<br />

W/V<br />

DEXTROSE 5%W/V IN NACL<br />

0.15%W/V<br />

DEXTROSE 5%W/V IN NACL 0.45%<br />

W/V<br />

DEXTROSE 50% SOLUTION FOR<br />

INJECTION<br />

DEXTROSE 50% HYPERTONIC<br />

AGUETTANT<br />

DEXTROSE DEMO 20% SOLUTION FOR IV<br />

INFUSION<br />

DEXTROSE INFUSION<br />

SOLUTION/DEMO 5%<br />

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

25G/50ML PHARMAMED<br />

PARENTERALS LTD.<br />

INJECTABLE SOLUTION 50% LABORATOIRE<br />

AGUETTANT<br />

SOLUTION FOR<br />

INFUSION<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

PORTUGAL<br />

PORTUGAL<br />

UNITED KINGDOM<br />

PORTUGAL<br />

PORTUGAL<br />

UNITED KINGDOM<br />

PORTUGAL<br />

PORTUGAL<br />

PORTUGAL<br />

PORTUGAL<br />

PORTUGAL<br />

PORTUGAL<br />

PORTUGAL<br />

PORTUGAL<br />

PORTUGAL<br />

PORTUGAL<br />

MALTA<br />

FRANCE<br />

20% W/V DEMO SA GREECE<br />

N/A DEMO ABEE GREECE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 529<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DEXTROSE SOLN F/INFUSION<br />

DEMO<br />

DEXTROSE SOLUTION FOR<br />

INFUSION DEMO 10%<br />

SOLUTION FOR<br />

INFUSION<br />

DEXTROSE/DEMO 35% SOLUTION FOR<br />

INJECTION<br />

5% DEMO SA GREECE<br />

SOLUTIONFOR INFUSION 10% DEMO SA GREECE<br />

N/A DEMO SA GREECE<br />

DEZOR CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

DEZOR SHAMPOO 2% W/V HOE PHARMACEUTICALS<br />

SDN BHD<br />

DEZOR CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

DEZOR SHAMPOO LIQUID N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

DEZOR SHAMPOO SHAMPOO 2% W/V HOE PHARMACEUTICALS<br />

SDN. BHD<br />

DHC CONTINUS TABLETS 120MG MODIFIED RELEASE<br />

TABLET<br />

DHC CONTINUS TABLETS 90 MG MODIFIED RELEASE<br />

TABLET<br />

DHC-CONTINUS TABLETS 60MG MODIFIED RELEASE<br />

TABLETS<br />

120MG NAPP LABORATORIES<br />

LIMITED<br />

90MG NAPP LABORATORIIES<br />

LIMITED<br />

60MG NAPP LABORATORIES<br />

LIMITED<br />

DIA COLON SYRUP 66.7G/100ML VECCHI & C PIAM<br />

S.A.P.A.<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

DIABENESE TABLET 250MG PFIZER UNITED KINGDOM<br />

DIABINESE TABLETS 100MG PFIZER LIMITED UNITED KINGDOM<br />

DIABITOL TABLET 5MG TABLET 5MG SM PHARMACEUTICALS<br />

SDN BHD<br />

DIAGLIC TABLET 80MG OKAS PHARMA PVT LTD<br />

— INDIA<br />

ITALY<br />

MALAYSIA<br />

DIAMICRON TABLETS 80MG SERVIER PAKISTAN<br />

DIAMICRON TABLETS 80MG SERVIER EGYPT<br />

INDUSTRIES LTD<br />

DIAMICRON 80MG SCORED TABLET 80MG LES LABORATOIRES<br />

SERVIER<br />

DIAMICRON 80MG TABLET 80MG LABORATORIOS<br />

SERVIER, S.A.<br />

DIAMICRON MR MODIFIED RELEASE<br />

TABLET<br />

30MG LES LABORATOIRES<br />

SERVIER<br />

INDIA<br />

EGYPT<br />

FRANCE<br />

SPAIN<br />

FRANCE<br />

DIAMICRON TABLET TABLET 80MG SERVIER PAKISTAN<br />

DIAMORPHINE HYDROCHLORIDE<br />

BP<br />

DIAMORPHINE HYDROCHLORIDE<br />

BP<br />

DIAMORPHINE HYDROCHLORIDE<br />

BP<br />

POWDER FOR<br />

RECONSTITUTION<br />

POWDER FOR<br />

RECONSTITUTION<br />

POWDER FOR<br />

RECONSTITUTION<br />

500MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM<br />

30MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM<br />

10MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM


EN<br />

530 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DIAMORPHINE HYDROCHLORIDE<br />

BP<br />

DIAMORPHINE HYDROCLORIDE<br />

BP<br />

POWDER FOR<br />

RECONSTITUTION<br />

POWDER FOR<br />

RECONSTITUTION<br />

5MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM<br />

100MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM<br />

DIAMOX TABLET 250MG LEDERLE PAKISTAN<br />

DIAMOX TABLET 250MG WYETH-LEDERLE PAKISTAN<br />

DIAMOX TABLET 250MG CYANAMID OF GREAT<br />

BRITAIN LTD<br />

DIAMOX SODIUM PARENTERAL POWDER FOR INJECTION 500MG/VIAL CYANAMID OF GREAT<br />

BRITAIN LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

DIANE 35 TABLET NA SCHERING PAKISTAN<br />

DIANE-35 COATED TABLET N/A SCHERING AG GERMANY<br />

DIANEAL PD1 1,36% SOLUTION FOR<br />

INJECTION<br />

DIANEAL PD1 GLUCOSE 1.36% SOLUTION FOR<br />

INJECTIONS<br />

DIANEAL PD1 GLUCOSE<br />

2.27%W/V<br />

DIANEAL PD1 GLUCOSE<br />

3.86%W/V<br />

DIANEAL PD4 PERIT. DIALYSIS<br />

SOL. 1.36<br />

DIANEAL PD4 PERIT. DIALYSIS<br />

SOL. 2.27<br />

DIANEAL PD4 PERIT. DIALYSIS<br />

SOL. 3.86<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOL. F/<br />

INTRAPERITONEAL AD<br />

SOL. F/<br />

INTRAPERITONEAL AD<br />

SOL. F/<br />

INTRAPERITONEAL AD<br />

NA SALUS SLOVENIA<br />

13.6MG/1ML BAXTER HEALTHCARE<br />

LIMITED<br />

22.7MG/1ML BAXTER HEALTHCARE<br />

LIMITED<br />

38.6MG/ML BAXTER HEALTHCARE<br />

LIMITED<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

DIARREST SYRUP ORAL SOLUTION N/A GALEN LIMITED UNITED KINGDOM<br />

DIAZEM 60MG TABLET 60MG MEDOCHEMIE LTD CYPRUS<br />

DIAZEPAM TABLET 5MG RANBAXY IRELAND<br />

LIMITED<br />

IRELAND<br />

DIAZEPAM TABLETS 50MG PHARMAMED LTD. MALTA<br />

DIAZEPAM BP 10MG TABLET 10MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

DIAZEPAM BP 2MG TABLET 2MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

DIAZEPAM BP 5MG TABLET 5MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

DIAZEPAM DESITIN RECTAL SOLUTION 5MG DESITIN ARZNEIMITTEL<br />

GMBH<br />

DIAZEPAM INJECTION BP SOLUTION FOR<br />

INJECTION<br />

DIAZEPAM INJECTION BP SOLUTION FOR<br />

INJECTION<br />

5MG/ML CP PHARMACEUTICALS<br />

LTD.)<br />

0.5% W/V PHOENIX<br />

PHARMACEUTICALS LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 531<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DIAZEPAM INJECTION BP 5MG/ML SOLUTION FOR<br />

INJECTION<br />

5MG/ML CP PHARMACEUTICALS<br />

LTD<br />

DIAZEPAM RECTAL TUBES 10MG RECTAL SOLUTION 4MG/ML CP PHARMACEUTICALS<br />

LTD.<br />

DIAZEPAM RECTAL TUBES 10MG RECTAL SOLUTION 10MG / TUBE CP PHARMACEUTICALS<br />

LTD<br />

DIAZEPAM RECTAL TUBES 2.5MG RECTAL SOLUTION 2MG/ML CP PHARMACEUTICALS<br />

LTD.<br />

DIAZEPAM RECTAL TUBES 5MG RECTAL SOLUTION 2MG/ML CP PHARMACEUTICALS<br />

LTD.<br />

DIAZEPAM RECTAL TUBES 5MG RECTAL SOLUTION 5MG / TUBE CP PHARMACEUTICALS<br />

LTD<br />

DIAZOL SUSPENSION 320MG/5ML ATCO LABORATORIES<br />

(PVT) LTD<br />

DIAZOL TABLETS 200MG ATCO LABORATORIES<br />

(PVT) LTD<br />

DIAZOL TABLETS 400MG ATCO LABORATORIES<br />

(PVT) LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

PAKISTAN<br />

PAKISTAN<br />

PAKISTAN<br />

DIBENYLINE CAPSULES 10MG CAPSULE 10MG FORLEY LIMITED UNITED KINGDOM<br />

DICALCI SOFT CAPSULES 1MCG KOREA UNITED PHARM.<br />

INC.<br />

DICETEL 100MG FILM-COATED TABLET 100MG LABORATOIRES SOLVAY<br />

PHARMA<br />

DICETEL 50MG FILM-COATED TABLET 50MG LABORATOIRES SOLVAY<br />

PHARMA<br />

DICLAC 50 ENTERIC-COATED<br />

TABLET<br />

DICLO 25 TABLET ENTERIC-COATED<br />

TABLET<br />

KOREA REPUBLIC<br />

FRANCE<br />

FRANCE<br />

50MG HEXAL AG GERMANY<br />

25MG CAMDEN INDUSTRIES (M)<br />

SDN. BHD.<br />

MALAYSIA<br />

DICLO-DENK 100 RECTAL SUPPOSITORIES 100MG E. DENK OHG GERMANY<br />

DICLO-DENK 100 RETARD TABLETS 100MG E. DENK OHG GERMANY<br />

DICLO-DENK 50 ENTERIC COATED<br />

TABLET<br />

50MG E. DENK OHG GERMANY<br />

DICLOFENAC SUPPOSITORIES 50MG GLAXO WELLCOME<br />

POZNAN S.A.<br />

DICLOFENAC SUPPOSITORIES 100MG GLAXO WELLCOME<br />

POZNAN S.A.<br />

DICLOFENAC GASTRO-RESISTANT<br />

TABLETS<br />

DICLOFENAC<br />

RETARD-RATIOPHARM<br />

POLAND<br />

POLAND<br />

TABLETS 25MG PHARMAMED LTD. MALTA<br />

PROLONGED RELEASE<br />

CAPSULE<br />

100MG RATIOPHARM GMBH GERMANY<br />

DICLOFENAC SODIUM OPHTHALMIC SOLUTION 0.1% W/V ALCON LABORATORIES<br />

INC.<br />

DICLOFENAC SODIUM ENTERIC COATED<br />

TABLETS<br />

DICLOFENAC SODIUM ENTERIC COATED<br />

TABLETS<br />

25MG NORTON HEALTHCARE<br />

LIMITED<br />

50MG NORTON HEALTHCARE<br />

LIMITED<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

532 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DICLOFENAC SODIUM TABLET 25MG DEXCEL-PHARMA<br />

LIMITED<br />

DICLOFENAC SODIUM SOLUTION FOR<br />

INJECTION<br />

DICLOFENAC SODIUM EC<br />

TABLETS 25MG<br />

DICLOFENAC SODIUM EC<br />

TABLETS 25MG<br />

DICLOFENAC SODIUM TABLETS<br />

25MG<br />

DICLOFENAC SODIUM TABLETS<br />

50MG<br />

GASTRO-RESISTANT<br />

TABLET<br />

GASTRO-RESISTANT<br />

TABLET<br />

GASTRO-RESISTANT<br />

TABLET<br />

DICLOFENAC SR 100MG MODIFIED RELEASE<br />

TABLET<br />

DICLOFENAC SR 75MG MODIFIED RELEASE<br />

TABLET<br />

DICLOFENAC STADA 100<br />

RETARD<br />

DICLOFENAC STADA 100<br />

RETARD<br />

75MG/3ML PHARMAMED<br />

PARENTERALS LTD.<br />

UNITED KINGDOM<br />

MALTA<br />

25MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

25MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

25MG SANOFI WINTHROP<br />

LIMITED T/A STERWIN<br />

MEDICINES<br />

TABLET 50MG SANOFI WINTHROP<br />

LIMITED T/A STERWIN<br />

MEDICINES<br />

SUSTAINED RELEASE<br />

TABLETS<br />

SUSTAINED RELEASE<br />

TABLETS<br />

100MG SANOFI WINTHROP<br />

LIMITED T/A STERWIN<br />

MEDICINES<br />

75MG SANOFI WINTHROP<br />

LIMITED T/A STERWIN<br />

MEDICINES<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

100MG STADAPHARM GMBH GERMANY<br />

100MG STADAPHARM GMBH GERMANY<br />

DICLOFENAC STADA 50 FILM COATED TABLETS 50MG STADAPHARM GMBH GERMANY<br />

DICLOFENAC STADA N INJECTABLE SOLUTION 75MG STADAPHARM GMBH GERMANY<br />

DICLOFENAC-RATIOPHARM 100<br />

ZAPFCHEN<br />

DICLOFENAC-RATIOPHARM 25<br />

TABLETTEN<br />

DICLOFENAC-RATIOPHARM 50<br />

TABLETTEN<br />

SUPPOSITORY 100MG RATIOPHARM GMBH GERMANY<br />

GASTRO-RESISTANT<br />

TABLET<br />

GASTRO-RESISTANT<br />

TABLET<br />

DICLOFENAC-RATIOPHARM UNO SUSTAINED RELEASE<br />

TABLET<br />

25MG RATIOPHARM GMBH GERMANY<br />

50MG RATIOPHARM GMBH GERMANY<br />

150MG RATIOPHARM GMBH GERMANY<br />

DICLOGESIC SUPPOSITORES 50MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

DICLOGESIC EYE DROPS 5MG/5ML DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD<br />

DICLOGESIC 100 SUPPOSITORIES SUPPOSITORIES 100MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD<br />

DICLOGESIC 12.5 SUPPOSITORIES SUPPOSITORIES 12.5MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD<br />

DICLOGESIC 25 ENTERIC COATED<br />

TABLETS<br />

25MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

DICLOMELAN FILM COATED TABLETS 50MG LANNACHER HEILMITTEL<br />

GES.M.B.H.<br />

JORDAN<br />

JORDAN<br />

JORDAN<br />

JORDAN<br />

JORDAN<br />

AUSTRIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 533<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DICLOMELAN SUPPOSITORY 100MG LANNACHER HEILMITTEL<br />

GMBH<br />

DICLOMELAN RETARD FILM COATED TABLETS 100MG LANNACHER HEILMITTEL<br />

GES.M.B.H.<br />

DICLORAN SR FILM COATED TABLET 100MG LEKAR PHARMA LIMITED INDIA<br />

DICLORENGEL GEL 1%W/W TRIMA ISRAEL<br />

PHARMACEUTICAL<br />

PRODUCTS LIMITED<br />

AUSTRIA<br />

AUSTRIA<br />

ISRAEL<br />

DICLOXIL 250 CAPSULES 250MG AEGIS LTD CYPRUS<br />

DICLOXIL 500 CAPSULES 500MG AEGIS LTD CYPRUS<br />

DICORTEN CREAM 0.05%W/W TRIMA ISRAEL<br />

PHARMACEUTICAL<br />

PRODUCTS LIMITED<br />

DICTON COUGH SYRUP SYRUP 220MG/100ML DOLORGIET GMBH & CO<br />

KG<br />

DICTON COUGH CAPSULES RETARD CAPSULE 30MG DOLORGIET GMBH & CO.<br />

KG<br />

DICTON COUGH RETARD<br />

CAPSULES<br />

RETARD CAPSULES 30MG DOLORGIET GMBH & CO<br />

KG<br />

DICTON COUGH SYRUP SOLUTION 220MG/100ML DOLORGIET GMBH & CO.<br />

KG<br />

ISRAEL<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

DICYNONE 250 TABLET 250MG OM PHARMA SA SWITZERLAND<br />

DICYNONE 500 TABLET 500MG OM PHARMA SA SWITZERLAND<br />

DIDRALIN TABLET 50MG MEDOCHEMIE LTD CYPRUS<br />

DIESPOR POWDER FOR INJECTION 1000MG BIOMEDICA FOSCAMA<br />

INDUSTRIA CHIMICO<br />

FARMACEUTICA S.P.A<br />

DIFENAC TABLETS 25MG TABLET 25MG DRUG HOUSES OF<br />

AUSTRALIA(ASIA) PTE<br />

LTD<br />

ITALY<br />

SINGAPORE<br />

DIFFERIN CREAM 0.1% GALDERMA(UK) LIMITED UNITED KINGDOM<br />

DIFFLAM COUGH LOZENGES N/A 3M PHARMACEUTICALS<br />

PTY LTD<br />

DIFFLAM ANTI-INFLAMMATORY<br />

LOZENGES<br />

LOZENGES N/A 3M PHARMACEUTICALS<br />

PTY LTD<br />

DIFFLAM 5% GEL GEL 5% W/W 3M PHARMACEUTICALS<br />

PTY LTD<br />

DIFFLAM ANTI-INFLAMMATORY<br />

LOZENGES<br />

DIFFLAM BLACKCURRANT S.F.<br />

COUGH LOZENGES<br />

LOZENGE N/A 3M PHARMACEUTICALS<br />

PTY LTD<br />

LOZENGES N/A 3M PHARMACEUTICALS<br />

PTY LTD.<br />

DIFFLAM CREAM CREAM 3% W/W 3M HEALTH CARE<br />

LIMITED<br />

DIFFLAM HONEY AND LEMON<br />

SUGAR FRE<br />

DIFFLAM LOZENGES RASBERRY<br />

SUGAR FREE<br />

LOZENGES NA 3M PHARMACEUTICALS<br />

LIMITED<br />

LOZENGES N/A 3M PHARMACEUTICALS<br />

LIMITED<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

AUSTRALIA


EN<br />

534 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DIFFLAM MOUTH GEL GEL N/A 3M PHARMACEUTICALS<br />

PTY LTD<br />

DIFFLAM ORAL RINSE GARGLE 0.15% W/V 3M HEALTH CARE<br />

LIMITED<br />

DIFFLAM ORANGE SUGAR FREE LOZENGES NA 3M PHARMACEUTICALS<br />

LIMITED<br />

DIFFLAM SPRAY 0.15%W/V OROMUCOSAL SPRAY 0.15% W/V 3M HEALTH CARE<br />

LIMITED<br />

DIFFLAM-C ANTI-INFLAMMATORY<br />

ANTISEPTIC<br />

DIFFLAM-C ANTI-INFLAMMATORY<br />

ANTISEPTIC<br />

SOLUTION N/A 3M PHARMACEUTICALS<br />

PTY LTD<br />

SOLUTION N/A 3M PHARMACEUTICALS<br />

PTY LTD<br />

AUSTRALIA<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

AUSTRALIA<br />

DIFLERIX 2.5MG CAPSULE 2.5MG MEDOCHEMIE LTD CYPRUS<br />

DIFLUCAN CAPSULE 150MG PFIZER UNITED KINGDOM<br />

DIFLUCAN CAPSULE 200MG PFIZER LIMITED UNITED KINGDOM<br />

DIFLUCAN CAPSULE 50MG PFIZER LIMITED UNITED KINGDOM<br />

DIFLUCAN INTAVENOUS SOLUTION N/A PFIZER LIMITED UNITED KINGDOM<br />

DIFLUCAN INTAVENOUS SOLUTION N/A PFIZER LIMITED UNITED KINGDOM<br />

DIFLUCAN POWDER FOR ORAL<br />

SUSPENS.<br />

DIFLUCAN POWDER FOR ORAL<br />

SUSPEN.<br />

50MG/5ML PFIZER LIMITED UNITED KINGDOM<br />

N/A PFIZER LIMITED UNITED KINGDOM<br />

DIGESTIVO ANTONETTO TABLETS N/A MARCO ANTONETTO<br />

SPA<br />

DIGESTIVO ANTONETTO TABLET N/A MARCO ANTONETTO<br />

SPA<br />

DIGIBIND DIGOXIN ANTIBODY<br />

(F(AB))<br />

DIGOXIN SOLUTION FOR<br />

INJECTION<br />

DIGOXIN INJECTION USP SOLUTION FOR<br />

INJECTION<br />

POWDER FOR INJECTION 38MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

0.5MG/2ML PHARMAMED<br />

PARENTERALS LTD.<br />

ITALY<br />

ITALY<br />

UNITED KINGDOM<br />

MALTA<br />

0.25MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

DIGOXIN TABLETS B.P. 0.25MG UNCOATED TABLET 0.25MG MEDICORP<br />

TECHNOLOGIES INDIA<br />

LTD<br />

DIHYDERGOT NASAL SPRAY 4MG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

DIHYDROCODEINE TABLETS 30MG NORTON HEALTHCARE<br />

LIMITED<br />

DIHYDROCODEINE 30MG TABLET 30MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

DIHYDROCODEINE TABLETS<br />

30MG<br />

DIHYDROCODEINE TABLETS BP<br />

30MG<br />

INDIA<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

TABLETS 30MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

TABLETS 30MG CP PHARMACEUTICALS UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 535<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DIHYDROCODEINE TABLETS BP<br />

30MG<br />

TABLET 30MG CP PHARMACEUTICALS<br />

LTD<br />

DILAPAN CAPSULES 150MG REMEDICA LTD CYPRUS<br />

DILAPROST 5MG 30 FILM<br />

COATED TABLET<br />

FILM-COATED TABLET 5MG BIOFARMA ILAC SAN.VE<br />

TIC. A.S.<br />

DILATREND TABLETS 12.5MG ROCHE DIAGNOSTICS<br />

GMBH<br />

DILATREND 25MG TABLET 25MG HOFFMANN-LA ROCHE<br />

AG<br />

DILATREND 6.25MG TABLET 6.25MG HOFFMANN-LA ROCHE<br />

AG<br />

DILGARD TABLET 60MG CIPLA LTD. INDIA<br />

DILTIAZEM HCL MODIFIED<br />

RELEASE<br />

DILTIAZEM HYDROCHLORIDE<br />

TABLETS 60MG<br />

DILTIAZEM HYDROCHLORIDE<br />

TABLETS BP 60MG<br />

TABLETS 60MG NORTON HEALTHCARE<br />

LIMITED<br />

MODIFIED RELEASE<br />

TABLET<br />

60MG CP PHARMACEUTICALS<br />

LTD<br />

TABLETS 60MG CP PHARMACEUTICALS<br />

LTD.<br />

DILTIZEM TABLET 30 MG MUSTAFA NEVZAT ILAC<br />

SANAYII A.S.<br />

DILTIZEM TABLET 60MG MUSTAFA NEVZAT ILAC<br />

SANAYII A.S.<br />

DILZACARD 60 MG TABLETS TABLETS 60MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD<br />

UNITED KINGDOM<br />

TURKEY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

TURKEY<br />

TURKEY<br />

JORDAN<br />

DIMA 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

DINDEVAN TABLET 50MG GOLDSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

DINEX-100 TABLET 100MG CIPLA LIMITED INDIA<br />

DINIKET SOLUTION FOR<br />

INFUSION<br />

10MG SCHWARZ PHARMA<br />

S.P.A.<br />

DIOCALM TABLETS N/A SETON PRODUCTS<br />

LIMITED<br />

UNITED KINGDOM<br />

ITALY<br />

UNITED KINGDOM<br />

DIOCIMEX TABLETS 100MG CIMEX AG SWITZERLAND<br />

DIORALYTE (BLACKCURRANT)<br />

POWDER<br />

POWDER FOR ORAL<br />

SOLUTION<br />

DIORALYTE NATURAL POWDER FOR ORAL<br />

SOLUTION<br />

DIORALYTE RELIEF POWDER FOR ORAL<br />

SOLUTION<br />

DIORALYTE SACHETS FOR<br />

SOLUTION (CITRUS)<br />

POWDER FOR ORAL<br />

SOLUTION<br />

N/A RORER<br />

PHARMACEUTICALS<br />

LIMITED T/A RPR FAMILY<br />

HEALTH DIVISION<br />

N/A RORER<br />

PHARMACEUTICALS<br />

LIMITED<br />

N/A MAY & BAKER LIMITED<br />

(T/A RHONE-POULENC<br />

RORER)<br />

N/A RORER<br />

PHARMACEUTICALS LTD.<br />

T/A RPR FAMILY HEALTH<br />

DIVISION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

536 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DIOSPER FILM COATED TABLETS NA KLEVA LIMITED GREECE<br />

DIOVAN CAPSULES 80MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

DIOVAN CAPSULES 160MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

DIOVAN FILM COATED TAB 80MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

DIOVAN FILM COATED TABLET 160MG NOVARTIS PHARMA<br />

SCHWIEZ AG<br />

DIOVAN FILM-COATED TABLETS 160 MG NOVARTIS<br />

FARMACEUTICA S.A. —<br />

SPAIN<br />

DIOVAN FILM-COATED TABLETS 80MG NOVARTIS<br />

FARMACEUTICA S.A. —<br />

SPAIN<br />

DIOVENOR FILM-COATED TABLETS 600MG LABORATOIRES<br />

INNOTHERA<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SPAIN<br />

SPAIN<br />

FRANCE<br />

DIPALAN 150 CAPSULES 150MG REMEDICA LTD CYPRUS<br />

DIPENTUM CAPSULES 250MG PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

SWEDEN<br />

DIPENTUM TABLET 500 MG TABLET 500MG PHARMACIA SVERIGE AB SWEDEN<br />

DIPHENHYDRAMINE CO COUGH<br />

LINCT. 14MG/5ML<br />

DIPHENHYDRAMINE CO COUGH<br />

LINCTUS<br />

DIPHTERIA AND TETANUS<br />

VACCINE (ADSORBED)<br />

DIPHTERIA AND TETANUS<br />

VACCINE ADSORBED<br />

DIPHTERIA AND TETANUS<br />

VACCINE PEDIATRIC<br />

DIPHTERIA-TETANUS-PERTUSSIS<br />

VACCINE ADS.<br />

DIPHTHERIA-TETANUS-PERTUSSIS<br />

VACCINE<br />

DIPHTHERIA AND TETANUS<br />

VACCINE ADSORBED<br />

DIPHTHERIA VACCINE<br />

(ADSORBED)<br />

ORAL SOLUTION N/A ROSEMONT<br />

PHARMACEUTICALS<br />

LIMITED<br />

ORAL SOLUTION 14MG/5ML ROSEMONT<br />

PHARMACEUTICALS LTD.<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

DIPRIVAN EMULSION FOR<br />

INJECTION<br />

DIPRIVAN EMULSION FOR<br />

INJECTION<br />

DIPRIVAN 2% EMULSION FOR<br />

INJECTION<br />

DIPROPHOS/DIPROFOS SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

0.5ML/DOSE SERUM INSTITUTE OF<br />

INDIA LTD<br />

N/A M/S SERUM INSTITUTE<br />

OF INDIA<br />

N/A M/S SERUM INSTITUTE<br />

OF INDIA LIMITED<br />

NA SERUM INSTITUTE OF<br />

INDIA LTD<br />

N/A SERUM INSTITUTE OF<br />

INDIA LTD<br />

INDIA<br />

INDIA<br />

INDIA<br />

INDIA<br />

INDIA<br />

N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

1% W/V ZENECA LIMITED UNITED KINGDOM<br />

20MG/ML ZENECA LIMITED UNITED KINGDOM<br />

20MG / ML ZENECA LIMITED UNITED KINGDOM<br />

N/A SCHERING-PLOUGH S.A. BELGIUM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 537<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DIPROSALIC OINTMENT N/A SCHERING-PLOUGH<br />

NV/SA<br />

BELGIUM<br />

DIPROSALIC LOTION N/A SCHERING-PLOUGH S.A. BELGIUM<br />

DIPROSONE CREAM 0.64MG/G SCHERING-PLOUGH<br />

NV/SA<br />

DIPROSONE OINTMENT 0.64MG/G SCHERING-PLOUGH<br />

NV/SA<br />

DIPROSONE LOTION 0.64MG/G SCHERING-PLOUGH<br />

NV/SA<br />

DIPYRIDAMOLE TABLETS 25MG NORTON HEALTHCARE<br />

LIMITED<br />

DIPYRIDAMOLE TABLETS 100MG NORTON HEALTHCARE<br />

LIMITED<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

DIPYRIDAMOLE COATED TABLET 100MG GENERICS(UK) LIMITED UNITED KINGDOM<br />

DISFLATYL DROPS ORAL EMULSION 40MG/ML SOLCO BASLE LTD. SWITZERLAND<br />

DISFLATYL TABLETS CHEWABLE TABLETS 40MG SOLCO BASLE LTD. SWITZERLAND<br />

DISIPAL TABLETS 50MG YAMANOUCHI PHARMA<br />

B.V.<br />

DISOPHROL SUSTAINED-ACTION<br />

TABLETS<br />

DISOPYRAMIDE PHOSPHATE<br />

CAPSULES BP 100MG<br />

N/A SCHERING-PLOUGH<br />

CORPORATION<br />

NETHERLANDS<br />

UNITED STATES OF<br />

AMERICA<br />

CAPSULE 100MG GENERICS[UK] LIMITED UNITED KINGDOM<br />

D-ISO-RATIOPHARM SACHET N/A RATIOPHARM GMBH GERMANY<br />

DISPERSIBLE ASPIRIN TABLET 75MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

DISPRIN TABLETS TABLET 300MG RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

DISPROL PARACETAMOL<br />

SUSPENSION<br />

DISPROL SOLUBLE<br />

PARACETAMOL TABLETS<br />

SUSPENSION 120MG/5ML RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

TABLET 120MG RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

DISTALGESIC TABLETS COATED TABLET N/A ELI LILLY & COMPANY<br />

LIMITED<br />

DISTILLED WITCH HAZEL BPC<br />

1973<br />

TOPICAL SOLUTION 100% V/V BELL SONS & CO<br />

(DRUGGISTS) LIMITED<br />

DITROPAN SCORED TABLET 5MG LABORATOIRES<br />

SYNTHELABO<br />

DITROPAN ELIXIR 2.5MG/5ML SYRUP 2.5MG/5ML LOREX SYNTHELABO UK<br />

& IRELAND LIMITED<br />

DITROPAN XL MODIFIED RELEASE<br />

TABLETS<br />

DITROPAN XL MODIFIED RELEASE<br />

TABLETS<br />

15MG SANOFI WINTHROP LTD<br />

T/A SANOFI<br />

SYNTHELABO<br />

5MG SANOFI WINTHROP<br />

LIMITED T/A SANOFI<br />

SYNTHELABO<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

538 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DITROPAN XL MODIFIED RELEASE<br />

TABLETS<br />

DIUMIDE-K CONTINUS TABLETS MODIFIED RELEASE<br />

TABLETS<br />

DIUREMID 20MG INJECTION SOLUTION FOR<br />

INJECTION<br />

10MG SANOFI WINTHROP LTD<br />

T/A SANOFI<br />

SYNTHELABO<br />

N/A NAPP LABORATORIES<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

20MG HOVID SDN BHD MALAYSIA<br />

DIVIDOL TABLETS 10MG REMEDICA LTD. CYPRUS<br />

DIVIR-100 TABLETS 100MG CIPLA LIMITED INDIA<br />

DNCG STADA AUGENTROPFEN SOLUTION 20MG/ML STADAPHARM GMBH GERMANY<br />

DOBUJECT 50MG/ML CONC. FOR PARENT.<br />

INFUS.<br />

DOBUTAMINE INJECTION SOLUTION FOR<br />

INJECTION<br />

DOBUTREX LIQUID CONC FOR<br />

INF<br />

DOBUTREX SOLUTION CONCENTRATE FOR<br />

INFUSION<br />

50MG/ML LEIRAS OY FINLAND<br />

12.5MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

CONC. FOR INF. 250MG/VIAL LILLY DEUTSCHLAND<br />

GMBH<br />

250MG/20ML LILLY DEUTSCHLAND<br />

GMBH<br />

DOCUSATE CALCIUM CAP 240MG CAPSULE 240MG TARO<br />

PHARMACEUTICALS INC.<br />

DOCUSATE SOD CAP 100MG CAPSULE 100MG TARO<br />

PHARMACEUTICALS INC.<br />

DOGMATIL 200MG TABLET 200MG LABORATOIRES<br />

SYNTHELABO<br />

DOGMATIL 50MG CAPSULE 50MG LABORATOIRES<br />

SYNTHELABO<br />

DOLAL LINIMENT N/A LABORATOIRES<br />

BIOCODEX<br />

DOLGIT 600 SUGAR COATED<br />

TABLETS<br />

600MG DOLORGIET GMBH & CO.<br />

KG<br />

DOLGIT CREAM CREAM 5G/100G DOLORGIET GMBH & CO.<br />

KG<br />

DOLGIT CREAM CREAM 5G/100G DOLORGEIT GMBH &<br />

COKG<br />

GERMANY<br />

GERMANY<br />

CANADA<br />

CANADA<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

DOLOBENE GEL N/A MEPHA PHARMA AG SWITZERLAND<br />

DOLOBID 250MG TABLET 250MG MERCK SHARP & DOHME<br />

B.V.<br />

NETHERLANDS<br />

DOLOFEN-500 LACTAB 500MG MEPHA PHARMA AG SWITZERLAND<br />

DOLO-GESIC FILM COATED TABLET 50MG ALFARES<br />

PHARMACEUTICALS<br />

DOLO-GESIC, FILM-COATED<br />

TABLET<br />

FILM-COATED TABLET 50MG ALFARES<br />

PHARMACEUTICALS<br />

DOLVAN TABLETS TABLETS N/A NORMA CHEMICALS<br />

LIITED<br />

SYRIA<br />

SYRIA<br />

UNITED KINGDOM<br />

DOMAR CAPSULE 5MG POLIPHARM CO. LTD. THAILAND<br />

DONA CAPSULE 250MG ROTTAPHARM S.R.L. ITALY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 539<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DONORMYL 15MG SCORED FILM-COATED<br />

TABLET<br />

15MG LABORATOIRES OBERLIN FRANCE<br />

DONORMYL 15MG SCORED EFF. TABLETS 15MG LABORATOIRES OBERLIN FRANCE<br />

DOPAMET 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS<br />

DOPAMINE 200 PIERRE FABRE<br />

200MG/5ML<br />

DOPAMINE 50 PIERRE FABRE<br />

50MG/10ML<br />

INJ. SOL. FOR INFUSION 200MG/5ML PIERRE FABRE<br />

MEDICAMENT<br />

INJECT. SOL. FOR<br />

INFUSION<br />

DOPAMINE CONC. SELECTAJET SOLUTION FOR<br />

INJECTION<br />

50MG/10ML PIERRE FABRE<br />

MEDICAMENT<br />

40MG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

FRANCE<br />

FRANCE<br />

UNITED KINGDOM<br />

DOPATAB M250 TABLET 250MG HOVID SDN BHD MALAYSIA<br />

DOPEGYT TABLETS 250MG EGIS PHARMACEUTICALS<br />

LTD<br />

DOPERGIN TABLET 0.2MG LABORATOIRE<br />

SCHERING<br />

HUNGARY<br />

FRANCE<br />

DOPERGIN TABLETS 0.2MG SCHERING PAKISTAN<br />

DORMICUM FILM-COATED TABLET 7.5MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

DORMICUM AMPOULE 5MG/5ML ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

DORMONOCT TABLET 1MG HOECHST MARION<br />

ROUSSEL LIMITED<br />

DORYX 100 CAPSULE 100MG FAULDING<br />

PHARMACEUTICALS<br />

DORYX 50 CAPSULE 50MG FAULDING<br />

PHARMACEUTICALS<br />

DOSTINEX TABLETS 0.5MG PHARMACIA & UPJOHN<br />

S.P.A<br />

DOSTINEX TABLETS 0.5MG PHARMACIA & UPJOHN<br />

S.P.A<br />

DOTHIEPIN CAPSULES 25MG NORTON HEALTHCARE<br />

LIMITED<br />

DOTHIEPIN TABLETS 75MG NORTON HEALTHCARE<br />

LIMITED<br />

SWITZERLAND<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

AUSTRALIA<br />

DOXAT 100 TABLETS F.C. 100MG AEGIS LTD CYPRUS<br />

DOXAT 100 CAPSULE 100MG AEGIS LTD CYPRUS<br />

DOXAT 50 TABLETS F.C. 50MG AEGIS LTD. CYPRUS<br />

DOXEPIN HDROCHLORIDE CAPSULES 25MG DANBURY PHARMACAL<br />

INC.<br />

DOXIBIOTIC CAPSULES 100MG CTS CHEMICAL<br />

INDUSTRIES LTD<br />

DOXIBIOTIC CAPSULES 100MG CTS CHEMICAL<br />

INDUSTRIES<br />

ITALY<br />

ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

ISRAEL<br />

ISRAEL<br />

DOXIPROCT OINTMENT N/A LABORATOIRES OM S.A. SWITZERLAND


EN<br />

540 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DOXIPROCT SUPPOSITORY N/A LABORATOIRES OM S.A. SWITZERLAND<br />

DOXIPROCT PLUS OINMENT N/A LABORATOIRES OM S.A. SWITZERLAND<br />

DOXIPROCT PLUS SUPPOSITORY N/A LABORATOIRES OM S.A. SWITZERLAND<br />

DOXIUM TABLET 250MG LABORATOIRES OM S.A. SWITZERLAND<br />

DOXIUM 500 CAPSULE 500MG LABORATOIRES OM S.A. SWITZERLAND<br />

DOXIVENIL GEL N/A LABORATOIRES OM S.A. SWITZERLAND<br />

DOXOLEM (WITHOUT<br />

METHYLPARABEN)<br />

DOXORUBICIN HCL FOR INJ. USP<br />

LYOPHILISED<br />

DOXORUBICIN HYDROCHLORIDE<br />

INJ. VIAL<br />

DOXORUBICIN HYDROCHLORIDE<br />

INJECTION VIAL<br />

DOXORUBICIN HYDROCLORIDE<br />

INJ LYOPHILISED<br />

POWDER FOR INJECTION 50MG/10ML LEMERY, S.A. DE C.V. MEXICO<br />

LYOPHILISED CAKE FOR<br />

INJ<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

LYOPHILISED CAKE FOR<br />

INJ<br />

10MG M/S SERUM INSTITUTE<br />

OF INDIA LIMITED<br />

10MG/5ML F.H. FAULDING & CO.<br />

LTD. (T/A DAVID BULL<br />

LABS)<br />

50MG/25ML F.H. FAULDING & CO.<br />

LTD. (T/A DAVID BULL<br />

LABS)<br />

50MG M/S SERUM INSTITUTE<br />

OF INDIA LIMITED<br />

INDIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

DOXYCYCLIN STADA 100 FILM COATED TABLETS 100MG STADAPHARM GMBH GERMANY<br />

DOXYCYCLINE CAPSULES 50MG NORTON HEALTHCARE<br />

LIMITED<br />

DOXYCYCLINE CAPSULES 100MG NORTON HEALTHCARE<br />

LIMITED<br />

DOXYCYCLINE TABLETS 100MG PHARMAMED LTD. MALTA<br />

DOXYDAR 100 CAPSULES 100MG DAR AL SAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

JORDAN<br />

DOXYHEXAL CAPSULE 100MG HEXAL AG GERMANY<br />

DOXYHEXAL 200 CAPSULE 200MG HEXAL AG GERMANY<br />

DOXYHEXAL TABS TABLET 100MG HEXAL AG GERMANY<br />

DOXYLIN TABLET 50MG ALPHAPHARM PTY<br />

LIMITED<br />

DOXYLIN 100 TABLET 100MG ALPHAPHARM PTY<br />

LIMITED<br />

DOXYN CAPSULES 100MG ATCO LABORATORIES<br />

(PVT) LTD<br />

DRAMAMINE TABLETS 50MG MONSANTO PLC T/A<br />

SEARLE<br />

DRAPOLENE CREAM N/A GLAXO WELLCOME<br />

GROUP<br />

DRAPOLENE CREAM CREAM N/A GLAXO WELLCOME UK<br />

LIMITED<br />

DRICLOR TOPICAL SOLUTION 20% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

AUSTRALIA<br />

AUSTRALIA<br />

PAKISTAN<br />

UNITED KINGDOM<br />

POLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 541<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DRIED FACTOR VIII FRACTION,<br />

TYPE 8Y,<br />

POWDER FOR INJECTION N/A BPL, BIO PRODUCTS<br />

LABORATORY<br />

DRIN TABLETS N/A ALFA WASSERMANN<br />

S.P.A.<br />

DRIPTANE 5MG SCORED TABLET 5MG LABORATOIRES DEBAT FRANCE<br />

DRISTAN NASALSPRAY 0.05% W / W WHITEHALL<br />

LABORATORIES LTD<br />

DRISTAN DECONGESTANT TABLETS N/A WHITEHALL<br />

LABORATORIES LTD<br />

DROPSTAR TG EYE DROPS NA FARMIGEA S.P.A. ITALY<br />

DROPTIMOL OPHTHALMIC DROPS 0.5% W/V FARMIGEA SPA ITALY<br />

DROPTIMOL OPHTHALMIC DROPS 0.25% W/V FARMIGEA SPA ITALY<br />

UNITED KINGDOM<br />

ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

D-STOP-RATIOPHARM FILM COATED TABLET 2MG RATIOPHARM GMBH GERMANY<br />

DUAL LAX EXTRA STRONG<br />

TABLETS<br />

COATED TABLETS N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

DUAL LAX NORMAL TABLETS COATED TABLET N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

DUBAM CREAM CREAM N/A NORMA CHEMICALS<br />

LIMITED<br />

DUBAM SPRAY AEROSOL SPRAY N/A NORMA CHEMICALS<br />

LIMITED<br />

DUINUM 50MG TABLET 50MG MEDOCHEMIE LTD CYPRUS<br />

DUKORAL ORAL LIQ & EFF.<br />

GRANULES<br />

NA SBL VACCIN AB SWEDEN<br />

DULCOLAX S.C. TABLETS 5MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

DULCOLAX SUPPOSITORY 5MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

DULCOLAX SUPPOSITORY 10MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

DULCOLAX TABLET 5MG BOEHRINGER INGELHEIM PAKISTAN<br />

DULCOLAX ENTERIC COATED<br />

TABLET<br />

5MG BOEHRINGER-INGELHEIM PAKISTAN<br />

DUOFILM TOPICAL SOLUTION N/A STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

DUOGAS EFFERVESCENT<br />

GRANULES<br />

N/A BRACCO S.P.A ITALY<br />

DUPHALAC SYRUP 667G/L SOLVAY<br />

PHARMACEUTICALS B.V.<br />

DUPHALAC DRY POWDER >=95% W/W SOLVAY<br />

PHARMACEUTICALS B.V.<br />

DUPHASTON TABLET 10MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

DUPHASTON FILM-COATED TABLET 10MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS


EN<br />

542 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DURACEF SUSPENSION 5% W / V BRISTOL-MYERS SQUIBB<br />

S.P.A<br />

DURACEF CAPSULES 500MG BRISTOL-MYERS SQUIBB<br />

HOLDINGS LTD<br />

DURACEF POWDER FOR ORAL<br />

SUSP.<br />

500MG/5ML (10%) BRISTOL MYERS SQUIBB<br />

S.P.A.<br />

DURACEF SUSPENSION 5%(250MG/5ML) BRISTOL MYERS SQUIBB<br />

S.P.A.<br />

DURACEF SUSPENSION<br />

250MG/5ML<br />

POWDER FOR ORAL<br />

SUSPENSIO<br />

250MG/5ML BRISTOL-MYERS SQUIBB<br />

HOLDINGS LTD<br />

DURAKINASE INJECTION POWDER FOR INJECTION 750000 UI DONG KOOK PHARM.<br />

CO. LTD<br />

DURAKINASE INJECTION POWDER FOR INJECTION 1500000 IU DONG KOOK PHARM.<br />

CO. LTD<br />

DUR-ELIX PLUS ORAL LIQUID NA 3M PHARMACEUTICALS<br />

LIMITED<br />

DUROAMINE CAPSULES 30MG MODIFIED RELEASE<br />

CAPSULES<br />

30MG 3M HEALTH CARE<br />

LIMITED<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

UNITED KINGDOM<br />

KOREA REPUBLIC<br />

KOREA REPUBLIC<br />

AUSTRALIA<br />

DUROGESIC 25MCG/H PATCH 25MCG/H JANSSEN-CILAG N.V. BELGIUM<br />

DUROGESIC TTS 100MCG/H PATCH 100MCG/H JANSSEN-CILAG N.V. BELGIUM<br />

DUROGESIC TTS 50MCG/H PATCH 50MCG/H JANSSEN-CILAG N.V. BELGIUM<br />

DUROGESIC TTS 75MCG/H PATCH 75MCG/H JANSSEN-CILAG N.V. BELGIUM<br />

DURO-TUSS COUGH LOZENGES LOZENGE N/A 3M PHARMACEUTICALS<br />

PTY LTD<br />

DURO-TUSS COUGH LOZENGES LOZENGES N/A 3M PHARMACEUTICALS<br />

PTY LTD<br />

DURO-TUSS DECONGESTANT ORAL LIQUID N/A 3M PHARMACEUTICALS<br />

PTY LTD<br />

DURO-TUSS EXPECTORANT ORAL LIQUID N/A 3M PHARMACEUTICALS<br />

PTY LTD<br />

DURO-TUSS FORTE ORAL LIQUID 3MG/ML 3M PHARMACEUTICALS<br />

PTY LTD<br />

DURO-TUSS MUCOLYTIC COUGH<br />

LIQUID<br />

ORAL LIQUID 0.8MG/ML 3M PHARMACEUTICALS<br />

LIMITED<br />

DURO-TUSS REGULAR ORAL LIQUID 1MG/ML 3M PHARMACEUTICALS<br />

PTY LTD<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

AUSTRALIA<br />

DURO-TUSS SINUS ORAL LIQUID N/A AUST R 54130 AUSTRALIA<br />

DUSPATALIN LIQUID SUSPENSION 10MG/ML SOLVAY<br />

PHARMACEUTICALS B.V.<br />

DUXIL COATED TABLET N/A LES LABORATOIRES<br />

SERVIER<br />

DUXIL ORAL SUSPENSION N/A LES LABORATOIRES<br />

SERVIER<br />

DUXIMA IM VIAL 1G ECOBI FARMACEUTICI<br />

S.A.S<br />

DYAZIDE TABLETS TABLET N/A SMITHKLINE & FRENCH<br />

LABORATORIES LIMITED<br />

NETHERLANDS<br />

FRANCE<br />

FRANCE<br />

ITALY<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 543<br />

Trade Name Dosage Form Dose MA Holder Country<br />

DYCLOMAX 100MG DELAYED RELEASE<br />

TABLET<br />

100MG SMITHKLINE BEECHAM<br />

PHARMA GMBH<br />

DYCLOMAX 100MG SUPPOSITORY 100MG SMITHKLINE BEECHAM<br />

PHARMA GMBH<br />

DYCLOMAX 50MG ENTERIC COATED<br />

TABLET<br />

DYCLOMAX 75MG/3ML SOLUTION FOR<br />

INJECTION<br />

DYNASTAT POWDER FOR SOLUTION<br />

FOR INJECTION<br />

DYNASTAT POWDER FOR SOLUTION<br />

FOR INJECTION<br />

50MG SMITHKLINE BEECHAM<br />

PHARMA GMBH<br />

75MG/3ML SMITHKLINE BEECHAM<br />

PHARMA GMBH<br />

20MG PHARMACIA EUROPE<br />

EEIG<br />

40MG PHARMACIA EUROPE<br />

EEIG<br />

DYSPAMET SUSPENSION ORAL SUSPENSION 4%W/V GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED<br />

DYSPAMET SUSPENSION<br />

200MG/5ML<br />

ORAL SUSPENSION 200MG/5ML SMITHKLINE & FRENCH<br />

LABORATORIES LIMITED<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

DYSPORT INJECTION POWDER FOR INJECTION 500 UNITS IPSEN LIMITED UNITED KINGDOM<br />

E45 CREAM CREAM N/A CROOKES HEALTHCARE<br />

LIMITED<br />

E45 ITCH RELIEF CREAM CREAM N/A CROOKES HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

EAREX EAR DROPS EAR DROPS N/A PHARMALAB LTD UNITED KINGDOM<br />

EAU PRECIEUSE TOPICAL SOLUTION N/A PARKE-DAVIS FRANCE<br />

EBRILON TABLETS 250MG MEDOCHEMIE LTD CYPRUS<br />

ECHINACEA TABLETS COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

ECOCAIN SOLUZIONE INIETTABILE 20MG/ML MOLTENI DENTAL SRL ITALY<br />

ECOCAIN 8704 FLAC. NEBULIZZATORE NS MOLTENI DENTAL SRL ITALY<br />

ECOCAIN A50 SOLUTION FOR<br />

INJECTION<br />

ECOCAIN A80 SOLUTION FOR<br />

INJECTION<br />

ECOCAIN CON ADRENALINA<br />

1:100,000<br />

ECOCAIN CON ADRENALINA<br />

1:80,000<br />

ECOCILLIN CAPSULE MOLLI<br />

VAGINALI<br />

ECOCILLIN, CAPSULE MOLLI<br />

VAGINALI<br />

N/A MOLTENI DENTAL S.R.L. ITALY<br />

N/A MOLTENI DENTAL S.R.L. ITALY<br />

SOLUZIONE INIETTABILE 20MG/ML MOLTENI DENTAL SRL ITALY<br />

SOLUZIONE INIETTABILE 20MG/ML MOLTENI DENTAL SRL ITALY<br />

CAPSULE MOLLI<br />

VAGINALI<br />

NA PROGE FARM S.R.L. ITALY<br />

100000000 UFF PROGE FARM S.R.L ITALY<br />

ECOCORT CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

ECOCORT CREAM CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD<br />

ECODERGIN VAGINAL CREAM 1% W/W FARMIGEA SPA ITALY<br />

MALAYSIA<br />

MALAYSIA


EN<br />

544 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ECODERGIN VAGINAL OVULE 150MG FARMIGEA SPA ITALY<br />

ECODERGIN CREAM NA FARMIGEA SPA ITALY<br />

ECOMI' VAGINAL OVULES 150MG GEYMONAT SPA ITALY<br />

ECOMI' TOPICAL SOLUTION N/A GEYMONAT SPA ITALY<br />

ECOMI' CREAM N/A GEYMONAT SPA ITALY<br />

ECONEX-400 TABLETS N/A MACLEODS<br />

PHARMACEUTICALS LTD<br />

ECONEX-800 TABLET N/A MACLEODS<br />

PHARMACEUTICALS LTD<br />

ECOX-800 TABLET 800MG MACLEODS INDIA<br />

EDRONAX TABLETS 4MG PHARMACIA & UPJOHN<br />

S.P.A<br />

EDRONAX TABLETS 4MG PHARMACIA ITALIA S.P.A ITALY<br />

EFEXOR TABLETS 37.5MG LEDERLE PAKISTAN<br />

EFEXOR — TAB 50 MG TABLETS 50MG WYETH-AYERST<br />

CANADA INC.<br />

EFEXOR — TAB 75 MG TABLET 75MG WYETH-AYERST<br />

CANADA INC.<br />

EFEXOR TAB 37.5 MG TABLETS 37.5MG WYETH-AYERST<br />

CANADA INC.<br />

EFEXOR TAB 50MG TABLETS 50MG WYETH-AYERST<br />

CANADA INC.<br />

EFEXOR TAB 75MG TABLETS 75MG WYETH-AYERST<br />

CANADA INC<br />

EFEXOR TABLETS TABLET 37.5MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

—UK<br />

EFEXOR TABLETS TABLETS 75MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

UK<br />

EFEXOR XL CAPSULE 75MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

—UK<br />

EFEXOR XL 150MG CAPSULES 150MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

EFEXOR XL CAPSULES CAPSULES 75MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

EFEXOR XR CAPSULE SUSTAINED RELEASE<br />

CAPSULE<br />

EFEXOR XR CAPSULES SUSTAINED RELEASE<br />

CAPSULE<br />

75MG WYETH-AYERST<br />

CANADA INC.<br />

150MG WYETH-AYERST<br />

CANADA INC.<br />

INDIA<br />

INDIA<br />

ITALY<br />

CANADA<br />

CANADA<br />

CANADA<br />

CANADA<br />

CANADA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

CANADA<br />

CANADA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 545<br />

Trade Name Dosage Form Dose MA Holder Country<br />

EFEXORXL 150 MG MODIFIED<br />

RELEASECAPSULE<br />

CAPSULE 150MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES-<br />

UK<br />

EFFACNE 5 TOPICAL GEL 5G/100G LABORATOIRES LA<br />

ROCHE-POSAY<br />

UNITED KINGDOM<br />

FRANCE<br />

EFFERALGAN PAEDIATRIC 3% ORAL SOLUTION 3% W / V LABORATOIRES UPSA FRANCE<br />

EFFERALGAN VITAMIN C SCORED EFF. TABLETS N/A LABORATOIRES UPSA FRANCE<br />

EFFERCITRATE TABLETS EFFERVESCENT TABLET N/A TYPHARM LIMITED UNITED KINGDOM<br />

EFFEXOR TAB 37.5MG TABLET 37.5MG WERTH-AYERST<br />

CANADA INC.<br />

CANADA<br />

EFFICO TONIC ORAL SOLUTION 0.18MG/5ML PHARMAX LIMITED UNITED KINGDOM<br />

EFFORTIL DROPS SOLUTION 0.75G/100G BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

EFLORAN SOLUTION FOR<br />

INFUSION<br />

500MG/100ML KRKA, D.D., NOVO<br />

MESTO<br />

EFUDIX CREAM 5% W/W ICN PHARMACEUTICALS<br />

LTD<br />

GERMANY<br />

SLOVENIA<br />

UNITED KINGDOM<br />

EGOCORT CREAM 10MG/G EGO PHARMACEUTICALS AUSTRALIA<br />

ELBAT TABLET 250MG GENEPHARM S.A. GREECE<br />

ELDOPAQUE FORTE CREAM 4 % ICN PHARMACEUTICALS<br />

INC.<br />

ELDOPAQUE FORTE 4% CREAM 4% W/W ICN PHARMACEUTICALS,<br />

INC.<br />

ELDOQUIN FORTE 4% CREAM ICN PHARMACEUTICALS<br />

INC.<br />

ELDOQUIN FORTE 4% CREAM 4% W/W ICN PHARMACEUTICALS<br />

INC.<br />

ELECTROLADE BANANA POWDER FOR ORAL<br />

SOLUTION<br />

ELECTROLADE BANANA POWDER FOR ORAL<br />

SOLUTION<br />

ELECTROLADE BLACKCURRANT POWDER FOR ORAL<br />

SOLUTION<br />

ELECTROLADE BLACKCURRANT POWDER FOR ORAL<br />

SOLUTION<br />

ELECTROLADE LEMON AND LIME POWDER FOR ORAL<br />

SOLUTION<br />

ELECTROLADE MELON POWDER FOR ORAL<br />

SOLUTION<br />

ELECTROLADE ORANGE POWDER FOR ORAL<br />

SOLUTION<br />

N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

546 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ELECTROLADE ORANGE POWDER FOR ORAL<br />

SOLUTION<br />

N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

ELIDIL CREAM 1% NOVARTIS HEALTHCARE<br />

A/S<br />

UNITED KINGDOM<br />

DENMARK<br />

ELINAP TABLETS 100MG KLEVA LIMITED GREECE<br />

ELITAN TABLET 10MG MEDOCHEMIE LTD CYPRUS<br />

ELITAN 10MG SUPPOSITORY 10MG MEDOCHEMIE LTD CYPRUS<br />

ELITAN 10MG/2ML LIQUID FOR INJECTION 10MG/2ML MEDOCHEMIE LTD CYPRUS<br />

ELITAN 20MG SUPPOSITORY 20MG MEDOCHEMIE LTD CYPRUS<br />

ELMETIN 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS<br />

ELMETIN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS<br />

ELOCOM CREAM 0.1% W/W S-P CANADA CANADA<br />

ELOCOM OINTMENT 0.1% W/W S-P CANADA CANADA<br />

ELOCOM LOTION 1MG/G S-P CANADA CANADA<br />

ELOQUINE 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS<br />

ELOXATIN 5MG/ML POWDER FOR<br />

SOL FOR INF.<br />

POWDER FOR SOL. FOR<br />

INF.<br />

5MG/ML SANOFI WINTHROP<br />

LIMITED<br />

FRANCE<br />

ELPEGON ORAL SUSPENSION 5MG/5ML ELPEN PHARM CO. INC. GREECE<br />

ELPEGON TABLET 5MG ELPEN S.A. GREECE<br />

ELPEGON TABLET 10MG ELPEN S.A. GREECE<br />

ELTROXIN TABLETS 100MCG GOLSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

ELTROXIN TABLET 50MCG GOLDSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

ELTROXIN TABLETS 100MCG TABLET 100MCG GOLDSHIELD<br />

PHARMACEUTICALS LTD<br />

ELTROXIN TABLETS 50 MCG TABLET 50MCG GOLDSHIELD<br />

PHARMACEUTICALS LTD<br />

ELUMATIC III SOLUTION FOR<br />

INJECTION<br />

NA CIS BIO INTERNATIONAL FRANCE<br />

EMADINE EYE DROPS, SOLUTION 0.5MG/ML ALCON LABORATORIES<br />

(UK) LTD<br />

EMESET SOLUTION FOR<br />

INJECTION<br />

EMESET INJECTION SOLUTION FOR<br />

INJECTION<br />

2MG/4ML CIPLA LTD INDIA<br />

2ML CIPLA INDIA<br />

EMESET-4 TABLETS 4MG CIPLA LTD INDIA<br />

EMLA CREAM N/A ASTRA LAKEMEDEL AB SWEDEN<br />

EMOCLOT D.I. SOLUTION FOR<br />

INJECTION<br />

1000I.U. KEDRION S.P.A. ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 547<br />

Trade Name Dosage Form Dose MA Holder Country<br />

EMOCLOT D.I. SOLUTION FOR<br />

INJECTION<br />

1000I.U. KEDRION S.P.A. ITALY<br />

EMTHEXATE TABLETS 2.5MG PHARMACHEMIE B.V. NETHERLANDS<br />

EMULSIFYING OINTMENT BP OINTMENT N/A ADAMS HEALTHCARE<br />

LIMITED<br />

E-MYCIN POWDER FOR ORAL<br />

LIQUID<br />

200MG/5ML ALPHAPHARM PTY<br />

LIMITED<br />

E-MYCIN TABLET 400MG ALPHAPHARM PTY<br />

LIMITED<br />

ENACE TABLETS 10MG ATCO LABORATORIES<br />

(PVT) LTD<br />

ENACE TABLETS 5MG ATCO LABORATORIES<br />

(PVT) LTD<br />

ENALAPRIL MALEATE TABLET 20MG RANBAXY<br />

LABORATORIES LTD.<br />

ENALAPRIL MALEATE TABLETS 20MG VYSALI<br />

PHARMACEUTICALS<br />

LIMITED<br />

ENALAPRIL MALEATE TABLETS 20MG NORTON HEALTHCARE<br />

LTD<br />

ENALAPRIL MALEATE TABLETS<br />

5MG<br />

ENANTONE POWDER FOR IM/SC<br />

INJECT.<br />

ENANTONE POWDER FOR IM/SC<br />

INJECT.<br />

TABLET 5MG SANOFI WINTHROP<br />

LIMITED T/A STERWIN<br />

MEDICINES<br />

3.75MG TAKEDA ITALIA<br />

FARMACEUTICI S.P.A.<br />

11.25MG TAKEDA ITALIA<br />

FARMACEUTICI S.P.A.<br />

ENAP TABLET 5MG KRKA, D.D., NOVO<br />

MESTO<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

AUSTRALIA<br />

PAKISTAN<br />

PAKISTAN<br />

INDIA<br />

INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

SLOVENIA<br />

ENATEC 10 TABLETS 10MG MEPHA PHARMA AG SWITZERLAND<br />

ENATEC 20 TABELTS 20MG MEPHA PHARMA AG SWITZERLAND<br />

ENATEC 5 TABLETS 5MG MEPHA PHARMA AG SWITZERLAND<br />

ENBREL SOLUTION FOR<br />

INJECTION<br />

25MG WYETH EUROPA LTD UNITED KINGDOM<br />

ENBREL POWDER FOR INJECTION 25MG IMMUNEX<br />

CORPORATION<br />

UNITED STATES OF<br />

AMERICA<br />

ENDEKAY FLOUTABS 2-4 YEARS TABLET 1.1MG MANX PHARMA LIMITED UNITED KINGDOM<br />

ENDEKAY FLUORINSE DENTAL SOLUTION 2% W/V MANX PHARMA LIMITED UNITED KINGDOM<br />

ENDEKAY FLUOTABS 4+ YEARS TABLET 2.2MG MANX PHARMA LIMITED UNITED KINGDOM<br />

ENDOBULIN S/D 500MG POWDER FOR INJECTION NS BAXTER AG AUSTRIA<br />

ENDOXAN SUGAR-COATED<br />

TABLETS<br />

50MG ASTA MEDICA GERMANY<br />

ENDOXAN POWDER FOR INJECTION 200MG ASTA MEDICA GERMANY<br />

ENDOXAN POWDER FOR INJECTION 500MG ASTA MEDICA GERMANY<br />

ENDOXAN POWDER FOR INJECTION 1G ASTA MEDICA GERMANY


EN<br />

548 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ENELFA 125 SUPPOSITORIES 125MG DOLORGEIT GMBH & CO<br />

KG<br />

ENELFA 125MG SUPPOSITORY 125MG DOLORGIET GMBH & CO.<br />

KG<br />

ENELFA 250 SUPPOSITORIES SUPPOSITORIES 250MG DOLORGEIT GMBH & CO<br />

KG<br />

ENELFA 250MG SUPPOSITORY 250MG DOLORGIET GMBH & CO,<br />

KG<br />

ENELFA 500 SUPPOSITORY 500MG DOLORGIET GMBH & CO.<br />

KG<br />

ENELFA SYRUP SOLUTION 2G/100ML DOLORGIET GMBH & CO.<br />

KG<br />

ENELFA SYRUP SOLUTION SYRUP 100ML DOLORGEIT GMBH & CO<br />

KG<br />

ENGERIX B SUSPENSION FOR<br />

INJECTION<br />

ENGERIX B SUSPENSION FOR<br />

INJECTION<br />

ENGERIX B SUSPENSION FOR<br />

INJECTION<br />

ENGERIX B JUNIOR SUSPENSION FOR<br />

INJECTION<br />

ENO POWDER FOR ORAL<br />

SOLUTION<br />

ENPRIN GASTRO-RESISTANT<br />

TABLET<br />

ENPRIN GASTRO-RESISTANT<br />

TABLET<br />

ENTOCORT SOLUBLET AND SOL FOR<br />

ENEMA<br />

ENTOCORT PROLONGED RELEASE<br />

CAPSULE<br />

10MCG/0.5ML SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

20MCG/ML SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

NA SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

NA GLAXOSMITHKLINE<br />

BIOLOGICALS SA<br />

N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

UNITED KINGDOM<br />

75MG HEALTHY IDEAS LIMITED UNITED KINGDOM<br />

75MG HEALTHY IDEAS LIMITED UNITED KINGDOM<br />

0.02MG/ML TIKA LAKEMEDEL AB SWEDEN<br />

3MG TIKA LAKEMEDEL AB SWEDEN<br />

ENTOX-P TABLET 500MG CYNAMID (PAKISTAN)<br />

LIMITED<br />

ENTROCALM LOPERAMIDE CAPSULES 2MG GALPHARM<br />

HEALTHCARE LIMITED<br />

ENTROCALM REPLACE GRANULES FOR ORAL<br />

SOLN.<br />

ENTROCALM REPLACE GRANULES FOR ORAL<br />

SOL.<br />

PAKISTAN<br />

UNITED KINGDOM<br />

N/A HEALTHY IDEAS LIMITED UNITED KINGDOM<br />

N/A HEALTHY IDEAS LIMITED UNITED KINGDOM<br />

ENZIFLUR TABLET 5MG BROS LTD GREECE<br />

EOLARIX POWDER FOR INJECTION N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

EPADOREN SOLUTION FOR<br />

INECTION<br />

BELGIUM<br />

N/A DEMO ABEE SA GREECE<br />

EPADOREN COATED TABLET 150MG DEMO ABEE GREECE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 549<br />

Trade Name Dosage Form Dose MA Holder Country<br />

EPADOREN SYRUP 75MG/5ML DEMO ABEE GREECE<br />

EPANUTIN CAPSULE 100MG PARKE-DAVIS GMBH GERMANY<br />

EPANUTIN CAPSULES 25MG CAPSULE 25MG WARNER LAMBERT (UK)<br />

LIMITED<br />

EPANUTIN CAPSULES 300MG CAPSULE 300MG WARNER LAMBERT (UK)<br />

LIMITED<br />

EPANUTIN CAPSULES 50MG CAPSULE 50MG WARNER LAMBERT (UK)<br />

LIMITED<br />

EPANUTIN PARENTERAL SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

250MG/5ML PARKE-DAVIS GMBH GERMANY<br />

EPANUTIN SUSPENSION ORAL SUSPENSION 30MG/5ML WARNER LAMBERT (UK)<br />

LIMITED<br />

EPAXAL BERNA SOLUTION FOR<br />

INJECTION<br />

N/A ISTITUTO<br />

SIEROTERAPICO BERNA<br />

S.R.L.<br />

EPHEDRINE AGUETTANT 3% INJECTABLE SOLUTION 3% W/V LABORATOIRE<br />

AGUETTANT<br />

EPHEDRINE HYDROCHLORIDE BP<br />

30MG<br />

EPHEDRINE HYDROCHLORIDE BP<br />

30MG/ML<br />

EPHEDRINE HYDROCHLORIDE<br />

TABLETS BP 15MG<br />

EPHEDRINE HYDROCHLORIDE<br />

TABLETS BP 30MG<br />

EPHEDRINE SULFATE INJECTION<br />

USP<br />

TABLET 30MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

SOLUTION FOR<br />

INJECTION<br />

3%W/V MACARTHYS LABORAT.<br />

LTD. T/A MARTINDALE<br />

PHARMACEUTICALS LTD<br />

TABLETS 15MG CP PHARMACEUTICALS<br />

LTD.<br />

TABLETS 30MG CP PHARMACEUTICALS<br />

LTD.<br />

SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

ITALY<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

50MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

EPIFOAM TOPICAL AEROSOL N/A SCHWART PHARMA INC UNITED STATES OF<br />

AMERICA<br />

EPILAT SOFT GELATIN CAPSULES 10MG EGYPTIAN<br />

INTERNATIONAL<br />

PHARMACEUTICAL<br />

INDUSTRIES CO (EIPICO)<br />

EPILIM 100MG CRUSHABLE TABLET 100MG SANOFI WINTHROP<br />

LIMITED<br />

EPILIM 200MG ENTERIC COATED<br />

TABLET<br />

EPILIM 500MG ENTERIC COATED<br />

TABLET<br />

EPILIM CHRONO 300MG MODIFIED RELEASE<br />

TABLET<br />

EPILIM INTRAVENOUS POWDER<br />

FOR INJECTION<br />

EPILIM/SODIUM VALPROATE<br />

200MG/5ML LIQUID<br />

EPINEPHRINE (ADRENALINE) INJ<br />

MINIJET<br />

200MG SANOFI WINTHROP<br />

LIMITED<br />

500MG SANOFI WINTHROP<br />

LIMITED<br />

300MG SANOFI SYNTHELABO<br />

LIMITED<br />

POWDER FOR INJECTION 400MG/VIAL SANOFI WINTHROP<br />

LIMITED<br />

ORAL SOLUTION 200MG/5ML SANOFI WINTHROP<br />

LIMITED<br />

AQUEOUS SOLUTION 1MG/10ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

EGYPT<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

550 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

EPINEPHRINE (ADRENALINE) INJ.<br />

MINIJET<br />

SOLUTION FOR<br />

INJECTION<br />

1:10,000 INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

EPIRAZOLE CAPSULE 20MG EGYPTIAN<br />

INTERNATIONAL<br />

PHARMACEUTICAL<br />

INDUSTRIES CO (EIPICO)<br />

UNITED KINGDOM<br />

EPIVIR ORAL SOLUTION 10MG/ML GLAXO GROUP LTD. UNITED KINGDOM<br />

EPIVIR COATED TABLETS 150MG GLAXO GROUP LTD. UNITED KINGDOM<br />

EGYPT<br />

EPOKELAN SCALP LOTION 2% W/W MEDOCHEMIE LTD CYPRUS<br />

EPPY EYE DROPS 1% W/V CHAUVIN<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

EPREX INJECTION SOLUTION SEE REMARKS JANSSEN-CILAG AG SWITZERLAND<br />

EPREX 10000U/ML INJECTION<br />

SOLUTION<br />

EPREX 10000U/ML INJECTION<br />

SOLUTION<br />

EPREX 1000U/0.5ML INJECTION<br />

SOLUTION<br />

EPREX 2000U/0.5ML INJECTION<br />

SOLUTION<br />

EPREX 2000U/ML INJECTION<br />

SOLUTION<br />

EPREX 3000U/0.3ML INJECTION<br />

SOLUTION<br />

EPREX 4000U/0.4ML INJECTION<br />

SOLUTION<br />

EPREX 4000U/ML INJECTION<br />

SOLUTION<br />

PREFILLED SYRINGE 10000 IU/ML JANSSEN-CILAG AG SWITZERLAND<br />

VIAL 10000 IU/ML JANSSEN-CILAG AG SWITZERLAND<br />

PREFILLED SYRINGE 1000 IU/0.5ML JANSSEN-CILAG AG SWITZERLAND<br />

PREFILLED SYRINGE 2000 IU/0.5ML JANSSEN-CILAG AG SWITZERLAND<br />

VIAL 2000 IU/ML JANSSEN-CILAG AG SWITZERLAND<br />

PREFILLED SYRINGE 3000 IU/0.3ML JANSSEN-CILAG AG SWITZERLAND<br />

PREFILLED SYRINGE 4000 IU/0.4ML JANSSEN-CILAG AG SWITZERLAND<br />

VIAL 4000 IU/ML JANSSEN-CILAG AG SWITZERLAND<br />

EPSOM SALTS BP ORAL POWDER 100%W/W LCM LTD UNITED KINGDOM<br />

ERCEFURYL 200MG CAPSULE 200MG LABORATOIRES<br />

SYNTHELABO<br />

ERCEFURYL 4% ORAL SUSPENSION 4% W/W LABORATOIRES<br />

SYNTHELABO<br />

FRANCE<br />

FRANCE<br />

ERIOS SUSPENSION 200MG/5ML MEPHA PHARMA AG SWITZERLAND<br />

ERIOS-250 LACTAB 250MG MEPHA PHARMA AG SWITZERLAND<br />

ERIOS-500 LACTAB 500MG MEPHA PHARMA AG SWITZERLAND<br />

ERITROPIU TABLETS 80MG FARMA UNO SRL ITALY<br />

ERMYCED 125 ORAL SUSPENSION 125MG/5ML REMEDICA LTD CYPRUS<br />

ERVEVAX POWDER FOR INJECTION >=10(3) TCID50 SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

BELGIUM<br />

ERYACNE 4 GEL 4% W/W GALDERMA (UK) LIMITED UNITED KINGDOM<br />

ERYC CAPSULE 250MG FAULDING<br />

PHARMACEUTICALS<br />

AUSTRALIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 551<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ERYCYTOL DEPOT SOLUTION FOR<br />

INJECTION<br />

N/A LANNACHER HEILMITTEL<br />

GMBH.<br />

AUSTRIA<br />

ERYHEXAL 500 FILM-COATED TABLET 500MG HEXAL AG GERMANY<br />

ERYHEXAL FORTE SAFT GRANULES FOR<br />

SUSPENSION<br />

ERYHEXAL SAFT GRANULES FOR<br />

SUSPENSION<br />

ERYTHRO 125 GRANULES GRANULES FOR<br />

SUSPENSION<br />

400MG /5ML HEXAL AG GERMANY<br />

235MG/5ML HEXAL AG GERMANY<br />

125MG/5ML CAMDEN INDUSTRIES (M)<br />

SDN. BHD<br />

ERYTHRO 125 GRANULES GRANULES F/ORAL SUSP. 125MG/5ML CAMDEN INDUSTRIES (M)<br />

SDN. BHD.<br />

ERYTHRO-250 TABLET TABLET 250MG CAMDEN INDUSTRIES (M)<br />

SDN.BHD<br />

ERYTHROCIN LYOPHILIZED POWDER F/<br />

INJ.<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

1G ABBOTT FRANCE FRANCE<br />

ERYTHROCIN 250MG TABLETS COATED TABLETS 250MG ABBOTT LABORATORIES<br />

LIMITED<br />

ERYTHROCIN LACTOBIONATE 1G<br />

VIAL<br />

ERYTHROMYCIN<br />

(ERYTHRO-TEVA) TABLETS<br />

POWDER FOR IV<br />

INFUSION<br />

1G ABBOTT LABORATORIES<br />

LIMITED<br />

TABLET 250MG TEVA PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

ERYTHROMYCIN INJECTION VIAL POWDER FOR INJECTION 1G/VIAL F.H. FAULDING & CO.<br />

LTD. (T/A DAVID BULL<br />

LABS)<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ISRAEL<br />

ERYTHROMYCIN STEARATE TABLET 250MG PHARMAMED LTD. MALTA<br />

ERYTHROMYCIN STEARATE TABS<br />

ESTYMICIN<br />

ERYTHROPED PI 125MG/5ML GRANULES FOR ORAL<br />

SOL.<br />

FILM COATED TABLET 250MG TABLETS (INDIA) LIMITED INDIA<br />

125MG/5ML ABBOTT LABORATORIES<br />

LIMITED<br />

ESELAN ENTERIC CAPSULE 20MG ANFARM HELLAS S.A. GREECE<br />

ESKORNADE SPANSULE CAPSULES MODIFIED RELEASE<br />

CAPSULE<br />

N/A SMITHKLINE & FRENCH<br />

LABORATORIES LIMITED<br />

ESKORNADE SYRUP ORAL SOLUTION N/A SMITHKLINE & FRENCH<br />

LABORATORIES LIMITED<br />

ESMERON 100MG=10ML SOLUTION FOR<br />

INJECTION<br />

ESMERON 250MG=25ML SOLUTION FOR<br />

INJECTION<br />

ESMERON 50MG=5ML SOLUTION FOR<br />

INJECTION<br />

10MG/ML ORGANON TEKNIKA B.V.<br />

(PART OF AKZO NOBEL)<br />

10MG/ML ORGANON TEKNIKA B.V.<br />

(PART OF AKZO NOBEL)<br />

10MG/ML ORGANON TEKNIKA B.V.<br />

(PART OF AKZO NOBEL)<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

ESONIDE CREAM 0.025%W/W KLEVA LIMITED GREECE<br />

ESONIDE METER DOSE NASAL<br />

SPRAY<br />

ESONIDE METER DOSE NASAL<br />

SPRAY<br />

50MCG/DOSE KLEVA LIMITED GREECE<br />

100MCG/DOSE KLEVA LIMITED GREECE<br />

ESTRACOMB TTS TRANSDERMAL PATCH N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND


EN<br />

552 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ESTRACOMB TTS TRANSDERMAL PATCHES N/A NOVARTIS<br />

FARMACEUTICA S.A.<br />

SPAIN<br />

ESTRADERM TTS TRANSDERMAL PATCH 2MG NOVARTIS PHARMA<br />

S.P.A.<br />

ESTRADERM TTS TRANSDERMAL PATCHES 4MG NOVARTIS PHARMA<br />

S.P.A.<br />

ESTRADERM TTS 100 TRANSDERMAL PATCH 8MG/20CM(2) NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

ESTRADERM TTS 25 TRANSDERMAL PATCH 2MG/5CM(2) NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

ESTRADERM TTS 50 TRANSDERMAL PATCH 4MG/10CM(2) NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

ESTREVA TRANSDERMAL GEL 0.1G/100G LABORATOIRE<br />

THERMAX<br />

SPAIN<br />

ITALY<br />

ITALY<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

FRANCE<br />

ESTROFEM — 28 TABLETS TABLET 2MG NOVO NORDISK A/S DENMARK<br />

ESTROFEM FORTE 28 -TABLETS TABLET 4MG NOVO NORDISK DENMARK<br />

ETHAMBUTOL TABLETS 400MG PHARMAMED LTD. MALTA<br />

ETHAMBUTOL HCL TABLET 400MG MACLEODS INDIA<br />

ETHANOLAMINE OLEATE BP SOLUTION FOR<br />

INJECTION<br />

N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

ETHOMID TABLET 250MG MACLEODS INDIA<br />

ETHRANE SOLN F/INHALATION 99G/100ML ABBOTT S.P.A ITALY<br />

ETHYL CHLORIDE ‘DR. HENNING’ SPRAY LIQUID N/A DR. GEORG FRIEDRICH<br />

HENNING<br />

ETILTOX TABLETS 200MG A.F.O.M. MEDICAL SPA ITALY<br />

ETINILESTRADIOLO AMSA TABLETS 0.01MG A.M.S.A. S.R.L. ITALY<br />

ETOMIDATE LIPURO EMULSION FOR IV<br />

INJECTION<br />

20MG/10ML B.BRAUN MELSUNGEN<br />

AG<br />

GERMANY<br />

GERMANY<br />

ETOPOS INJECTABLE SOLUTION SEE REMARKS LEMERY S.A. DE C.V. MEXICO<br />

ETOPOSIDE INJECTION VIAL SOLUTION FOR<br />

INJECTION<br />

ETOPOSIDE MERCK 20MG/ML SOLUTION FOR<br />

PERFUSION<br />

ETOPOSIDE PHARMACIA CONCENTRATE FOR<br />

SOLUTION FOR<br />

INFUSION<br />

ETOPOSIDE PIERRE FABRE<br />

100MG/5ML<br />

ETOPUL SOLUTION FOR<br />

INJECTION<br />

100MG/5ML PHARMACIA (PERTH) PTY<br />

LIMITED<br />

AUSTRALIA<br />

20MG/ML MERCK GENERIQUES FRANCE<br />

20MG/ML PHARMACIA OY FINLAND<br />

INJ. SOL. FOR I.V. INF. 100MG/5ML PIERRE FABRE<br />

MEDICAMENT<br />

100MG KOREA UNITED PHARM.<br />

INC.<br />

ETOSID CAPSULES 50MG CIPLA LTD INDIA<br />

ETOSID CAPSULE 50 MG CIPLA LTD INDIA<br />

EUCARBON TABLETS N/A F.TRENKA CHEM-PHARM<br />

FABRIK G.M.B.H<br />

FRANCE<br />

KOREA REPUBLIC<br />

AUSTRIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 553<br />

Trade Name Dosage Form Dose MA Holder Country<br />

EUCYCLINE SYRUP 1MG/5ML DEMO ABEE GREECE<br />

EUGLUCON TABLET 5MG ROCHE PAKISTAN<br />

EUGLUCON TABLET 5MG BOEHRINGER-INGELHEIM PAKISTAN<br />

EUGLUCON 5MG TABLET 5MG HOFFMANN-LA ROCHE<br />

AG<br />

EULEXIN TABLETS TABLETS 250MG SCHERING-PLOUGH<br />

NV/SA<br />

EUMOVATE CREAM CREAM 0.05% W/W GLAXO WELLCOME UK<br />

LTD<br />

EUMOVATE CREAM CREAM 0.05%W/W GLAXO WELLCOME UK<br />

LIMITED<br />

EUMOVATE ECZEMA AND<br />

DERMATITIS CREAM<br />

CREAM 0.005% GLAXO WELLCOME UK<br />

LIMITED<br />

EUMOVATE OINTMENT OINTMENT 0.05% W/W GLAXO WELLCOME UK<br />

LTD<br />

EUPEN CAPSULE 500MG J.URIACH & CIA. S.A. SPAIN<br />

EUPEN BRONQUIAL CAPSULE N/A J.URIACH & CIA. S.A. SPAIN<br />

EUPEN DROPS ORAL SUSPENSION 100MG/ML J.URIACH & CIA. S.A. SPAIN<br />

EUPEN SACHETS 250MG GRANULES 250MG J.URIACH & CIA. S.A. SPAIN<br />

EURAX CREAM 100MG/G NOVARTIS CONSUMER<br />

HEALTH SA<br />

EURAX LOTION 100MG/G NOVARTIS CONSUMER<br />

HEALTH SA<br />

EUROCEFIX CAPSULES 500MG FARMA UNO SRL ITALY<br />

EUROCEFIX ORAL SUSPENSION 250MG/5ML FARMA UNO SRL ITALY<br />

EVISTA FILM COATED TABLETS 60MG ELI LILLY NEDERLAND<br />

B.V.<br />

GERMANY<br />

BELGIUM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

NETHERLANDS<br />

EVOREL 100 TRANSDERMAL PATCH 100MCG/24 JANSSEN-CILAG LIMITED SWITZERLAND<br />

EVOREL 50 TRANSDERMAL PATCH 50MCG/24 JANSSEN-CILAG LIMITED SWITZERLAND<br />

EVOREL 75 TRANSDERMAL PATCH 75MCG/24 JANSSEN-CILAG LIMITED SWITZERLAND<br />

EXACYL 0.5MG/5ML SOLUTION FOR<br />

INJECTION<br />

0.5MG/5ML SANOFI WINTHROP FRANCE<br />

EXELON ORAL SOLUTION 2MG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

EXELON ORAL SOLUTION 2MG/ML NOVARTIS<br />

EUROPHARMA LIMITED<br />

EXELON HARD GELATIN CAPSULE NA NOVARTIS PHARMA<br />

SCHWIEZ AG<br />

EXELON HARD CAPSULES 1.5MG NOVARTIS EUROPHARM<br />

LIMITED<br />

EXELON HARD CAPSULES 3MG NOVARTIS EUROPHARM<br />

LIMITED<br />

EXELON HARD CAPSULES 4.5MG NOVARTIS EUROPHARM<br />

LIMITED<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY


EN<br />

554 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

EXELON HARD CAPSULES 6MG NOVARTIS EUROPHARM<br />

LIMITED<br />

EXELON 0.5MG CAPSULES 0.5MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

EXELON 1.5MG CAPSULES 1.5MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

EXELON 1MG CAPSULES 1MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

EXELON 3MG CAPSULES 3MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

EXELON 4.5MG CAPSULES 4.5MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

EXELON 6MG CAPSULES 6MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

EUROPEAN COMMUNITY<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

EXOLIT 4MG/5ML ELIXIR 4MG/5ML MEDOCHEMIE LTD CYPRUS<br />

EXOLIT 8MG TABLET 8MG MEDOCHEMIE LTD CYPRUS<br />

EXOSURF NEONATAL POWDER FOR INJECTION 108MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

EXPECTORAN SYRUP N/A DR.GROSSMANN AG<br />

PHARMACA<br />

EXPECTORAN WITH CODEIN SYRUP N/A DR.GROSSMANN AG<br />

PHARMACA<br />

EXPULIN CHILDREN'S COUGH<br />

LINCTUS<br />

EXPULIN COUGH LINCTUS SUGAR<br />

FREE<br />

EXPULIN DECONGESTANT-<br />

BABIES AND CHILDREN<br />

ORAL SOLUTION (SUGAR<br />

FREE<br />

N/A MONMOUTH<br />

PHARMACEUTICALS<br />

LIMITED<br />

ORAL SOLUTION N/A MONMOUTH<br />

PHARMACEUTICALS LTD.<br />

ORAL SOLUTION N/A MONMOUTH<br />

PHARMACEUTICALS LTD.<br />

EXPUTEX ORAL LIQUID 250MG/5ML MONMOUTH<br />

PHARMACEUTICALS LTD.<br />

EXTRA STRENGTH COLD MED<br />

NIGHTTIME RELIEF<br />

EXTRA STRENGTH COLD MEDI.<br />

DAYTIME RELIEF<br />

TABLET N/A STANLEY<br />

PHARMACEUTICALS LTD<br />

TABLET N/A STANLEY<br />

PHARMACEUTICALS LTD<br />

EXTRAFER ORAL SOLUTION 113.5MG/10ML SO.SE.PHARM S.R.L. SOC.<br />

DI SERVIZ. PER L'INDUS.<br />

FARM. ED AFF<br />

EXTRANEAL (ICODEXTRIN 7.5%) SOL F/INTRAPERITONEAL<br />

ADM<br />

EZIPOL ENTERIC COATED<br />

CAPSULES<br />

FADOL POWDER FOR INJ.<br />

SOLUTION<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CANADA<br />

CANADA<br />

ITALY<br />

20MG KLEVA LIMITED GREECE<br />

100MG/250MG/500 LEMERY S.A. DE C.V. MEXICO<br />

FALICARD I.V. INJECTION SOLUTION 5MG/2ML ARZNEIMITTELWERK<br />

DRESDEN GMBH<br />

FAM-LAX PHENOLPHTHALEIN TABLETS N/A TORBET LABORATORIES<br />

LIMITED<br />

UNITED KINGDOM<br />

GERMANY<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 555<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FAM-LAX SENNA LAXATIVE TABLETS N/A MODERN HEALTH<br />

PRODUCTS LIMITED<br />

FAMO FILM COATED TABLETS 40MG CTS CHEMICAL<br />

INDUSTRIES LTD.<br />

FAMO 40 FILM COATED TABLET 40MG CTS CHEMICAL<br />

INDUSTRIES LTD<br />

FAMODAR TABLET 40MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

FAMVIR TABLETS 125MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

FAMVIR TABLETS 250MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

FAMVIR TABLETS 125MG NOVARTIS<br />

FARMACEUTICA S.A<br />

FAMVIR TABLETS 250MG NOVARTIS<br />

FARMACEUTICA S.A<br />

FAMVIR 125MG TABLET COATED TABLET 125MG SMITHKLINE BEECHAM<br />

PLC<br />

FAMVIR TABLETS 125 MG FILM-COATED TABLETS 125 MG NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

FAMVIR TABLETS 250 MG FILM-COATED TABLETS 250 MG NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

FAMVIR TABLETS 250MG COATED TABLET 250MG SMITHKLINE BEECHAM<br />

PLC<br />

FARMORUBICINA POWDER FOR INJECTION 10MG/VIAL PHARMACIA & UPJOHN<br />

S.P.A.<br />

FARMORUBICINA POWDER FOR INJECTION 50MG/VIAL PHARMACIA & UPJOHN<br />

S.P.A.<br />

FARMORUBICINA POWDER AND SOLVENT<br />

F/SOLN F/INJ.<br />

FARMORUBICINA SOLUTION FOR IV<br />

INFUSION<br />

FARMORUBICINA SOLUTION FOR IV<br />

INFUSION<br />

FARMORUBICINA POWDER FOR SOLUTION<br />

FOR INJECTION<br />

FARVIRAN VAGINAL DOUCHE,<br />

SOLUTION<br />

UNITED KINGDOM<br />

ISRAEL<br />

ISRAEL<br />

JORDAN<br />

SWITZERLAND<br />

SWITZERLAND<br />

SPAIN<br />

SPAIN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

N/A PHARMACIA ITALIA S.P.A ITALY<br />

10MG/5ML PHARMACIA ITALIA S.P.A ITALY<br />

50MG/25ML PHARMACIA ITALIA S.P.A ITALY<br />

50MG PHARMACIA ITALIA SPA ITALY<br />

3.3G/100ML FARMIGEA SPA ITALY<br />

FASIGYN TABLET 500MG PFIZER LIMITED UNITED KINGDOM<br />

FAST POWDER N/A MEDOCHEMIE LTD CYPRUS<br />

FASTUM GEL 2.5G/100G A.MENARINI INDUSTRIE<br />

FARMACEUTICHE<br />

RIUNITE S.R.L.<br />

FASTUM, TUBO CON DISPENSER GEL 2.5% A. MENARINI INDUSTRIE<br />

FARMACEUTICHE<br />

RIUNITE S.R.L.<br />

ITALY<br />

ITALY


EN<br />

556 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FAVE DI FUCA TABLETS N/A ROCHE S.P.A. ITALY<br />

FAVERIN 100 TABLET 100MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

FAVERIN 50 TABLET 50MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

FEFOL SPANSULE SUSTAINED RELEASE<br />

CAPSULE<br />

FEFOL SPANSULE CAPSULE MODIFIED RELEASE<br />

CAPSULE<br />

FEFOL Z SPANSULE CAPSULES MODIFIED RELEASE<br />

CAPSULE<br />

FEIBA S-TIM 4 FAKTOR VIII<br />

INHIBITOR<br />

DRY SUBS IN VIAL +<br />

SOLV.<br />

N/A SMITH KLINE &<br />

BEECHAM<br />

N/A SMITHKLINE & FRENCH<br />

LABORATORIES LIMITED<br />

N/A SMITHKLINE & FRENCH<br />

LABORATORIES LIMITED<br />

NETHERLANDS<br />

NETHERLANDS<br />

PAKISTAN<br />

500U/20ML BAXTER AG AUSTRIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FELDENE CAPSULE 20MG PFIZER LIMITED UNITED KINGDOM<br />

FELDENE CAPSULES 10MG PFIZER LIMITED UNITED KINGDOM<br />

FELDENE TOPICAL GEL N/A PFIZER LIMITED UNITED KINGDOM<br />

FELDENE TABLETS 20MG PFIZER LIMITED UNITED KINGDOM<br />

FELDENE TABLETS 20MG PFIZER LIMITED UNITED KINGDOM<br />

FELDENE CAPSULE 20MG PFIZER PAKISTAN<br />

FELDENE GEL 5MG/G PFIZER PAKISTAN<br />

FELDENE 0.5% GEL GEL N/A PFIZER SA BELGIUM<br />

FELDENE 20MG DISPERSIBLE TABLET 20MG PFIZER PAKISTAN<br />

FEMARA TABLETS 2.5MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

FEMARA COATED TABLET 2.5 MG NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

FEMINAX TABLET SEE REMARKS ROCHE PRODUCTS<br />

LIMITED<br />

FEMOSTON 1/10 TABLET N/A SOLVAY<br />

PHARMACEUTICALS B.V.<br />

FEMOSTON 2/10 TABLET N/A SOLVAY<br />

PHARMACEUTICALS B.V.<br />

FEMOSTON 2/20 TABLET N/A SOLVAY<br />

PHARMACEUTICALS B.V.<br />

FEMOSTON CONTI TABLET N/A SOLVAY<br />

PHARMACEUTICALS B.V.<br />

FEMULEN TABLETS 0.5MG MONSANTO PLC T/A<br />

SEARLE<br />

FEMULEN TABLETS 0.5MG MONSANTO PLC T/A<br />

SEARLE<br />

FENADOL SOLUTION FOR<br />

INJECTION<br />

75MG/3ML PROGE FARM S.R.L. ITALY<br />

FENADOL SUPPOSITORY 100MG PROGE FARM S.R.L. ITALY<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 557<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FENADOL ‘RETARD’ COMPRESSE 100MG PROGE FARM S.R.L ITALY<br />

FENADOL 5 FIALE 75MG/3ML FIALE 75MG / 3ML PFOGE FARM S.R.L ITALY<br />

FENADOL RETARD SLOW RELEASE TABLET 100MG PROGE FARM S.R.L. ITALY<br />

FENAMIDE TABLETS 50MG FARMIGEA SPA ITALY<br />

FENAMON 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS<br />

FENAMON 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS<br />

FENAMON S.R. 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS<br />

FENAZIL CREAM 2% LABORATORIO CHIMICO<br />

FARMACEUTICO A.<br />

SELLA S.R.L<br />

FENBID GEL 5% W/W GOLDSHIELD GROUP PLS UNITED KINGDOM<br />

FENBID SPANSULE MODIFIED RELEASE<br />

CAPSULE<br />

FENBID SPANSULE CAPSULES MODIFIED RELEASE<br />

CAPSULE<br />

ITALY<br />

300MG GOLDSHIELD GROUP PLC UNITED KINGDOM<br />

300MG MENLEY & JAMES<br />

LIMITED<br />

FENBUFEN CAPSULES 300MG NORTON HEALTHCARE<br />

LIMITED<br />

FENBUFEN TABLETS 300MG NORTON HEALTHCARE<br />

LIMITED<br />

FENBUFEN TABLETS 450MG NORTON HEALTHCARE<br />

LIMITED<br />

FENBUFEN 450MG TABLETS COATED TABLET 450MG SANOFI WINTHROP<br />

LIMITED T/A STERWIN<br />

MEDICINES<br />

FENBUFEN TABLETS 300MG TABLET 300MG SANOFI WINTHROP<br />

LIMITED T/A STERWIN<br />

MEDICINES<br />

FENESTIL PROLONGED RELEASE<br />

CAPSULE<br />

4MG NOVARTIS CONSUMER<br />

HEALTH SA<br />

FENISTIL GEL 1MG/G NOVARTIS CONSUMER<br />

HEALTH SA<br />

FENISTIL DROPS 1MG/ML NOVARTIS CONSUMER<br />

HEALTH SA<br />

FENISTIL SYRUP 0.5MG/5ML NOVARTIS CONSUMER<br />

HEALTH SA<br />

FENNINGS CHILDREN'S COOLING<br />

POWDER<br />

FENTANYL CITRATE SOLUTION FOR<br />

INJECTION<br />

FENTANYL CITRATE SOLUTION FOR<br />

INJECTION<br />

FENTANYL CITRATE SOLUTION FOR<br />

INJECTION<br />

FENTANYL CITRATE INJECTION SOLUTION FOR<br />

INJECTIONS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

ORAL POWDER 50MG ANGLIAN PHARMA PLC UNITED KINGDOM<br />

0.05MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

100MG//PER 2ML ANITGEN<br />

PHARMACEUTICALS LTD<br />

500MC/10ML ANTIGEN<br />

PHARMACEUTICALS<br />

100MCG/2ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

IRELAND<br />

IRELAND<br />

IRELAND


EN<br />

558 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FENTANYL CITRATE INJECTION SOLUTION FOR<br />

INJECTION<br />

FENTANYL-JANSSEN 0.05MG/ML<br />

10ML AMP<br />

FENTANYL-JANSSEN 0.05MG/ML<br />

2ML AMP<br />

500MCG/10ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

IRELAND<br />

AMPOULE 0.05MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

AMPOULE 0.05MG/ML JANSSEN-CILAG N.V BELGIUM<br />

FENULIN TABLETS TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

FERR. PHOS. 6X NEW ERA<br />

BIOCHEMIC NO.4<br />

TISSUE SALTS TABLETS<br />

NO.4<br />

FERROGRAD MODIFIED RELEASE<br />

TABLETS<br />

FERROGRAD FOLIC MODIFIED RELEASE<br />

TABLETS<br />

FERROGRADUMET MODIFIED RELEASE<br />

TABLETS<br />

NA NEW ERA<br />

LABORATORIES LIMITED<br />

325MG ABBOTT LABORATORIES<br />

LIMITED<br />

N/A ABBOTT LABORATORIES<br />

LIMITED<br />

325MG ABBOTT LABORATORIES<br />

LIMITED<br />

FERROGYN 80MG EFFERVESCENT TABLETS 80MG SOCIETA' DI SERVIZIO<br />

PER L'INDUSTRIA<br />

FARMACEUTICA<br />

FERRONAL TABLETS 300MG CTS CHEMICAL<br />

INDUSTRIES<br />

FERRONAL TABLETS TABLET 300MG CTS CHEMICAL<br />

INDUSTRIES LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

ISRAEL<br />

ISRAEL<br />

FERROUS FUMARATE 200 TABLETS 200MG REMEDICA LTD CYPRUS<br />

FERROUS GLUCONATE 30MG TABLET 300MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

FERROUS SULPHATE TABLETS BP<br />

200MG<br />

COATED TABLET 200MG RANBAXY IRELAND<br />

LIMITED<br />

FIBERCON CAPLETS 500MG LEDERLE<br />

PHARMACEUTICAL<br />

DIVISION OF AMERICA<br />

CYANAMID CO.<br />

FIBER-CON CAPLETS CAPLETS NS WYETH CONSUMER<br />

HEALTHCARE<br />

FIBRA 3 PWD FOR ORAL<br />

RECONSTITUTI<br />

UNITED KINGDOM<br />

IRELAND<br />

N/A BIODES, S.L. SPAIN<br />

FIERY JACK CREAM CREAM N/A RUDGE ROBERTS<br />

LIMITED<br />

FILAIR 100 INHALER AEROSOL 100MCG/ACTUAT. 3M HEALTH CARE<br />

LIMITED<br />

FILAIR 50 INHALER AEROSOL 50MCG/ACTUAT. 3M HEALTH CARE<br />

LIMITED<br />

FILAIR FORTE INHALER AEROSOL 250MCG/ACTUAT. 3M HEALTH CARE<br />

LIMITED<br />

FILICINE TABLET 5MG ADELCO-<br />

CHROMATOURGIA<br />

ATHINON<br />

E.COLOCOTRONIS BROS<br />

S.A.<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GREECE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 559<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FINCAR TABLETS 5MG CIPLA LTD INDIA<br />

FLAGENTYL 500MG TABLETS 500MG SPECIA LABORATORIES FRANCE<br />

FLAGYL TABLET 400MG RHONE POULENC RORER PAKISTAN<br />

FLAGYL TABLET 200MG RHONE POULENC RORER PAKISTAN<br />

FLAGYL FILM COATED TABLET 200MG RHONE-POULENC-RORER PAKISTAN<br />

FLAGYL FILM COATED TABLET 400MG RHONE-POULENC-RORER PAKISTAN<br />

FLAGYL SUPPOSITORIES 500MG HAWGREEN LIMITED UNITED KINGDOM<br />

FLAGYL INJECTION 0.5% W/V<br />

(100ML)<br />

SOLUTION FOR<br />

INJECTION<br />

0.5% W/V MAY & BAKER LIMITED UNITED KINGDOM<br />

FLAGYL S SUSPENSION N/A HAWGREEN<br />

LIMITED(IRELAND)<br />

FLAGYL S SUSPENSION ORAL SUSPENSION 200MG/5ML HAWGREEN LIMITED IRELAND<br />

FLAGYL TABLETS 200MG FILM COATED TABLET 200MG HAWGREEN LIMITED IRELAND<br />

FLAGYL TABLETS 400MG TABLET 400MG HAWGREEN LIMITED IRELAND<br />

FLAMAZINE 1% CREAM 1%W/W SMITH & NEPHEW<br />

PHARMACEUTICALS<br />

LIMITED<br />

FLAREX OPHTHALMIC SOLUTION 1MG/ML S.A. ALCON-COUVREUR<br />

N.V.<br />

FLEET ADULT GLYCERIN<br />

SUPPOSITORIES<br />

FLEET BABYLAX LIQ. GLYCERIN<br />

SUPP.<br />

FLEET CHILD GLYCERIN<br />

SUPPOSITORIES<br />

FLEET PHOSPHO-SODA ORAL<br />

SOLUTION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

BELGIUM<br />

SUPPOSITORIES 2G/SUPPOSITORY C.B. FLEET COMPANY UNITED STATES OF<br />

AMERICA<br />

LIQUID GLYCERIN SUPP. 2.3G/2.3ML C.B. FLEET COMPANY UNITED STATES OF<br />

AMERICA<br />

SUPPOSITORIES 1G/SUPPOSITORY C.B. FLEET COMPANY UNITED STATES OF<br />

AMERICA<br />

ORAL SOLUTION N/A E C DE WITT & CO LTD UNITED KINGDOM<br />

FLEET READY TO USE ENEMA RECTAL SOLUTION N/A E C DE WITT & CO LTD UNITED KINGDOM<br />

FLEET READY-TO-USE ENAMA<br />

F/CHILDREN<br />

ENEMA N/A C.B. FLEET COMPANY UNITED STATES OF<br />

AMERICA<br />

FLEET READY-TO-USE ENEMA ENEMA N/A C.B. FLEET COMPANY UNITED STATES OF<br />

AMERICA<br />

FLEMOXIN DROPS POWDER FOR<br />

SUSPENSION<br />

100MG/ML YAMANOUCHI PHARMA<br />

B.V.<br />

FLEMOXIN SOLUTAB 250 TABLETS 250MG YAMANOUCHI PHARMA<br />

B.V.<br />

FLEMOXIN SOLUTAB 500 TABLETS 500MG YAMANOUCHI PHARMA<br />

B.V.<br />

FLEMOXIN SUSPENSION POWDER FOR<br />

SUSPENSION<br />

FLEMOXIN SUSPENSION FORTE POWDER FOR<br />

SUSPENSION<br />

FLETCHERS' ARACHIS OIL<br />

RETENTION ENEMA<br />

LIQUID EVACUATION<br />

ENEMA<br />

125MG/5ML YAMANOUCHI PHARMA<br />

B.V.<br />

250MG/5ML YAMANOUCHI PHARMA<br />

B.V.<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

130ML PHARMAX LIMITED UNITED KINGDOM


EN<br />

560 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FLETCHERS' ENEMETTE LIQUID ENEMA SINGLE<br />

DOSE<br />

FLETCHERS' PHOSPHATE ENEMA LIQUID EVACUATION<br />

ENEMA<br />

FLEXIN-25 CONTINUS TABLETS MODIFIED RELEASE<br />

TABLET<br />

FLEXIN-50 CONTINUS TABLETS MODIFIED RELEASE<br />

TABLET<br />

FLEXIN-75 CONTINUS TABLETS MODIFIED RELEASE<br />

TABLETS<br />

N/A PHARMAX LIMITED UNITED KINGDOM<br />

N/A PHARMAX LIMITED UNITED KINGDOM<br />

25MG NAPP LABORATORIES<br />

LIMITED<br />

50MG NAPP LABORATORIES<br />

LIMITED<br />

75MG NAPP LABORATORIES<br />

LIMITED<br />

FLIXONASE AQUEOUS NASAL SPRAY N/A ALLEN & HANDBURY'S<br />

LIMITED UK<br />

FLIXONASE NASULE DROPS NASAL DROPS 400MCG GLAXO WELLCOME<br />

AUSTRALIA LTD<br />

FLIXONASE AQUEOUS NASAL<br />

SPRAY<br />

FLIXONASE AQUEOUS NASAL<br />

SPRAY<br />

FLIXONASE AQUEOUS NASAL<br />

SPRAY<br />

NASAL SPRAY 0.05% W/W GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

NASAL SPRAY 0.05%W/W GLAXO WELLCOME UK<br />

LIMITED<br />

NASAL SPRAY<br />

SUSPENSION<br />

50MCG GLAXO WELLCOME S.A.-<br />

SPAIN<br />

FLIXONASE NASULE DROPS NASAL DROPS 1MG/ML GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

FLIXOTIDE ACCUHALER INHALATION POWDER 50MCG GLAXO WELLCOME UK<br />

LIMITED<br />

FLIXOTIDE ACCUHALER INHALATION POWDER 100MCG/DOSE GLAXO WELLCOME UK<br />

LIMITED<br />

FLIXOTIDE ACCUHALER 250MCG INHALATION POWDER 250MCG/BLISTER GLAXO WELLCOME UK<br />

LIMITED<br />

FLIXOTIDE ACCUHALER 50MCG INHALATION POWDER 50MCG/BLISTER GLAXO WELLCOME UK<br />

LIMITED<br />

FLIXOTIDE DISKUS INHALATION POWDER 100MCG GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANDBURYS<br />

FLIXOTIDE DISKUS POWDER F/ORAL<br />

INHALATION<br />

FLIXOTIDE DISKUS POWDER F/ORAL<br />

INHALATION<br />

FLIXOTIDE DISKUS POWDER F/ORAL<br />

INHALATION<br />

50UG/DOSE LABORATOIRE GLAXO<br />

WELLCOME<br />

100UG/DOSE LABORATOIRE GLAXO<br />

WELLCOME<br />

250UG/DOSE LABORATOIRES GLAXO<br />

WELLCOME<br />

FLIXOTIDE DISKUS INHALATION POWDER 250MCG GLAXO WELLCOME UK<br />

LIMITED<br />

FLIXOTIDE DISKUS INHALTION POWDER 100MCG ALLEN AND HANBURY'S<br />

LTD -UK<br />

FLIXOTIDE DISKUS INHALTION POWDER 250 MCG ALLEN AND HANBURY'S<br />

LTD — UK<br />

FLIXOTIDE DISKUS 250MCG INHALATION POWDER 250MCG GLAXO WELLCOME UK<br />

LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

AUSTRALIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SPAIN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 561<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FLIXOTIDE DISKUS 50MCG INHALATION POWDER 50MCG GLAXO WELLCOME UK<br />

LTD<br />

FLIXOTIDE DISKUS 50MCG INHALATION POWDER 50MCG GLAXO WELLCOME UK<br />

LIMITED<br />

FLIXOTIDE EVOHALER AEROSOL 125UG/AC GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

FLIXOTIDE EVOHALER AEROSOL 250UG/AC GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

FLIXOTIDE EVOHALER AEROSOL 50MCG/AC GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

FLIXOTIDE EVOHALER PRESSURISED<br />

INHALATION<br />

SUSPENSION<br />

250MCG/AC ALLEN & HANDBURY'S<br />

LIMITED<br />

FLIXOTIDE EVOHALER 50MCG AEROSOL 50MCG/AC GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

FLIXOTIDE INHALER AEROSOL 125MCG/AC GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

FLIXOTIDE INHALER AEROSOL 250MCG/AC GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

FLIXOTIDE INHALER 125<br />

MICROGRAMS<br />

FLIXOTIDE INHALER 250<br />

MICROGRAMS<br />

AEROSOL 125MCG/AC GLAXO WELLCOME UK<br />

LTD<br />

AEROSOL 250MCG/AC GLAXO WELLCOME UK<br />

LTD<br />

FLIXOTIDE INHALER 50 AEROSOL 50MCG/AC GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

FLIXOTIDE INHALER 50<br />

MICROGRAMS<br />

AEROSOL 50MCG/AC GLAXO WELLCOME UK<br />

LTD<br />

FLIXOTIDE INHALER 50MCG AEROSOL 50MCG/AC GLAXO WELLCOME UK<br />

LIMITED<br />

FLIXOTIDE NEBULES SUSPENSION FOR<br />

INHALATION<br />

FLIXOTIDE NEBULES SUSPENSION FOR<br />

INHALATION<br />

FLIXOTIDE NEBULES INHALATION<br />

SUSPENSION<br />

FLIXOTIDE NEBULES INHALATION<br />

SUSPENSION<br />

FLIXOTIDE NEBULES 0.5MG/2ML INHALATION<br />

SUSPENSION<br />

FLIXOTIDE NEBULES 2MG/2ML INHALATION<br />

SUSPENSION<br />

0.5MG/2ML GLAXO WELLCOME<br />

AUSTRALIA LTD<br />

2MG/2ML GLAXO WELLCOME<br />

AUSTRALIA LTD<br />

0.5MG/2ML GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

2MG/2ML GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

0.5MG/2ML GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

2MG/2ML GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

UNITED KINGDOM<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

AUSTRALIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

562 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FLODOL CAPSULES 20MG FARMA UNO SRL ITALY<br />

FLODOL 1% GEL 1%W/W FARMA UNO SRL ITALY<br />

FLOGOFENAC GEL 1%W/W ECOBI FARMACEUTICI<br />

S.A.S<br />

FLOGOFENAC SUPPOSITORIES 100MG FARMACEUTICI ECOBI<br />

S.A.S<br />

FLOGOFENAC SOLUTION FOR<br />

INJECTION<br />

75MG/3ML FARMACEUTICI ECOBI<br />

SAS<br />

FLOGOFENAC RETARD CAPSULE 100MG FARMACEUTICI ECOBI<br />

SAS<br />

FLOGOPROFEN GEL 5G/100G CHIESI WASSERMANN<br />

S.A.<br />

FLOGOPROFEN SOLUTION 5G/100ML CHIESI WASSERMANN<br />

S.A.<br />

FLOGOPROFEN SOLUTION 5G/100ML CHIESI ESPANA S.A. SPAIN<br />

FLOGOPROFEN GEL GEL 5G/100G CHIESI ESPANA S.A. SPAIN<br />

FLOLAN SOLUTION FOR<br />

INJECTION<br />

0.5MG/2ML THE WELLCOME<br />

FOUNDATION LTD.<br />

FLOLAN POW AND SOL F/IV INF. 0.5MG THE WELLCOME<br />

FOUNDATION LTD.<br />

FLOMIST SPRAY N/A CIPLA LTD INDIA<br />

FLONITAL CAPSULE 20MG ANFARM HELLAS S.A. GREECE<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

SPAIN<br />

SPAIN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FLORINEF TABLETS 0.1MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

FLOXAPEN CAPSULES 250MG CAPSULE 250MG BEECHAM GROUP PLC UNITED KINGDOM<br />

FLOXAPEN CAPSULES 500MG CAPSULE 500MG BEECHAM GROUP PLC UNITED KINGDOM<br />

FLOXAPEN SYRUP POWDER FOR ORAL<br />

SOLUTION<br />

FLOXAPEN SYRUP POWDER F/SOL F/<br />

INJECTIONI<br />

FLOXAPEN SYRUP 125MG/5ML POWDER FOR ORAL<br />

SOLUTION<br />

FLOXAPEN VIALS FOR INJECTION<br />

250MG<br />

FLU RELIEF CAPSULES WITH<br />

DECONGESTANT<br />

250MG/5ML BEECHAM GROUP PLC UNITED KINGDOM<br />

125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM<br />

125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM<br />

POWDER FOR INJECTION 250MG BEECHAM GROUP PLC UNITED KINGDOM<br />

CAPSULE N/A GALPHARM<br />

HEALTHCARE LIMITED<br />

UNITED KINGDOM<br />

FLUANXOL TABLET 0.5MG H. LUNDBECK A/S DENMARK<br />

FLUANXOL DEPOT INJECTION<br />

100MG/ML<br />

FLUANXOL DEPOT INJECTION<br />

20MG/ML<br />

FLUARIX (INFLUENZA SPLIT<br />

VACCINE)<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SUSP. FOR IM/SC<br />

INJECTION<br />

100MG/ML H. LUNDBECK A/S DENMARK<br />

20MG/ML H. LUNDBECK A/S DENMARK<br />

N/A SACHSISCHES<br />

SERUMWERK DRESDEN<br />

(SMITHKLINE BEECHAM<br />

PHARMA)<br />

GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 563<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FLUARIX INFLUENZA SPLIT<br />

VACCINE<br />

SUSPENSION F IM SC INJ. NA SACHSISCHES<br />

SERUMWERK DRESDEN<br />

FLUCLOXACILLIN ORAL ELIXIR 125MG/5ML KENT<br />

PHARMACEUTICALS<br />

LIMITED<br />

FLUCLOXACILLIN CAPSULES 250MG NORTON HEALTHCARE<br />

LIMITED<br />

FLUCLOXACILLIN CAPSULES 500MG NORTON HEALTHCARE<br />

LIMITED<br />

FLUCLOXACILLIN ELIXIR 125MG/5ML NORTON HEALTHCARE<br />

LIMITED<br />

FLUCLOXACILLIN CAPSULES B.P. CAPSULES 250MG ATHLONE<br />

LABORATORIES LIMITED<br />

FLUCORAL 150MG CAPSULES CAPSULES 150MG BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

TURKEY<br />

FLUCOZAL 100 CAPSULES 100MG AEGIS LTD CYPRUS<br />

FLUCOZAL 150 CAPSULE 150MG AEGIS LTD. CYPRUS<br />

FLUCOZAL 200 CAPSULES 200MG AEGIS LTD CYPRUS<br />

FLUCOZAL 50 CAPSULES 50MG AEGIS LTD CYPRUS<br />

FLUDARA POWDER FOR INJECTION 50MG SCHERING AG GERMANY<br />

FLUDARA ORAL FILM COATED TABLET 10MG SCHERING HEALTH CARE<br />

LIMITED<br />

FLUDITEC 5% EXPECTORANT,<br />

SYRUP F/ADULTS<br />

ORAL SUSPENSION 5% INNOTECH<br />

INTERNATIONAL<br />

FLUIFORT SYRUP N/A DOMPE FARMACEUTICI ITALY<br />

FLUMETOL EYE DROPS N/A FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

FLUMETOL 'ANTIBIOTICO' EYE DROPS, POWD.<br />

+SOLVENT<br />

N/A FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

FLUMETOL 'SEMPLICE' EYE DROPS 0.2% W/V FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

FLUNIL-10 CAPSULES 10MG INTAS<br />

PHARMACEUTICALS<br />

LIMITED<br />

FLUNIL-10 10MG CAPSULES INTAS<br />

PHARMACEUTICALS LTD<br />

FLUNIL-20 CAPSULE 20MG INTAS<br />

PHARMACEUTICALS LTD<br />

FLUNIL-20 CAPSULES 20MG INTAS<br />

PHARMACEUTICALS LTD<br />

UNITED KINGDOM<br />

FRANCE<br />

FLUOCIM CAPSULES 20MG CIMEX AG SWITZERLAND<br />

FLUORESCEIN SODIUM 2% EYE DROPS 2% CHAUVIN<br />

PHARMACEUTICALS<br />

LIMITED<br />

FLUORESCEINE 10% SOLUTION FOR<br />

INJECTION<br />

100MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

ITALY<br />

ITALY<br />

ITALY<br />

INDIA<br />

INDIA<br />

INDIA<br />

INDIA<br />

UNITED KINGDOM<br />

SWITZERLAND


EN<br />

564 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FLUORESCEINE SODIQUE FAURE SOLUTION FOR<br />

INJECTION<br />

10% W/V CIBA VISION<br />

OPHTHALMICS<br />

FLUORETS OPHTHALMIC STRIPS 1MG/STRIP CHAUVIN<br />

PHARMACEUTICALS LTD.<br />

FLUORORINIL NASAL SPRAY,<br />

SUSPENSION<br />

FLUOROURACIL INJECTION BP SOLUTION FOR<br />

INJECTION<br />

FLUOROURACIL INJECTION BP SOLUTION FOR<br />

INJECTION<br />

FLUOROURACIL INJECTION VIAL SOLUTION FOR<br />

INJECTION<br />

FLUOTHANE LIQUID FOR<br />

INHALATION<br />

FLUOTHANE CONCENTRATE FOR INH.<br />

SOL.<br />

FLUOXETIN DELTA 10MG<br />

CAPSULES<br />

N/A FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

25MG/ML FAULDING<br />

PHARMACEUTICALS PLC<br />

50MG/ML FAULDING<br />

PHARMACEUTICALS PLC<br />

250MG/10ML F.H. FAULDING & CO.<br />

LTD. (T/A DAVID BULL<br />

LABS)<br />

FRANCE<br />

UNITED KINGDOM<br />

ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

0.01% W/W ZENECA LIMITED UNITED KINGDOM<br />

100% W/W ZENECA LIMITED UNITED KINGDOM<br />

CAPSULES DELTA HF — ICELAND ICELAND<br />

FLUOXETIN DELTA 20 MG CAPSULE 20MG DELTA HF ICELAND<br />

FLUPHENAZINE DECANOATE SOLUTION FOR<br />

INJECTION<br />

FLUPHENAZINE DECANOATE INJ.<br />

BP 100MG/ML<br />

FLUPHENAZINE DECANOATE<br />

INJECTION<br />

FLUPHENAZINE DECANOATE<br />

INJECTION<br />

FLUPHENAZINE DECANOATE<br />

INJECTION BP<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

25MG/1ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

100MG/ML FAULDING<br />

PHARMACEUTICALS PLC<br />

25MG/1ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

100MG/1ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

100MG/1ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

IRELAND<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

FLUSEMINAL F.C. TABLET 400MG ANFARM HELLAS S.A. GREECE<br />

FLUSENIL CAPSULE 50MG ANFARM HELLAS S.A. GREECE<br />

FLUSENIL CAPSULE 150MG ANFARM HELLAS S.A. GREECE<br />

FLUSOLV SOLUTION FOR<br />

INJECTION<br />

12500IU/0.5ML FARMACEUTICI ECOBI<br />

SAS<br />

FLUTAMIDA TABLETS 250MG LEMERY S.A. MEXICO<br />

FLUTAMIDE TAB 250MG TABLET 250MG PHARMASCIENCE INC. CANADA<br />

FLUTAMIDE TABLETS 250MG TABLET 250MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

FLUTAN 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS<br />

FLUVIRAL S/F SUS IM SUSPENSION FOR<br />

INJECTION<br />

ITALY<br />

N/A BIOCHEM VACCINES INC. CANADA<br />

FLUVOXAMINE TABLETS 100MG CP PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 565<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FLUVOXAMINE TABLETS BP<br />

100MG<br />

TABLET 100MG CP PHARMACEUTICALS<br />

LTD<br />

FLUXIL 20 CAPSULES 20MG AEGIS LTD, CYPRUS<br />

FLUZOLE 50MG 7 CAPSULE CAPSULE 50MG BIOFARMA ILAC SAN.VE<br />

TIC.A.S.<br />

FML LIQUIFILM STERILE OPHTHAL.<br />

SUSPEN.<br />

1MG/ML ALLERGAN<br />

PHARMACEUTICALS<br />

(IRELAND) LTD., INC.<br />

FOBAN OINTMENT 2% W/W HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

FOBAN CREAM 2% W/W HOE PHARMCEUTICALS<br />

SDN. BHD.<br />

FOBAN CREAM 2% W/W HOE PHARMACEUTICALS<br />

SDN BHD<br />

FOBAN OINTMENT 2% W/W HOE PHARMACEUTICALS<br />

SDN BHD<br />

FOBAN CREAM CREAM 2%W/W HOE PHARMACEUTICALS<br />

SDN. BHD<br />

FOBAN OINTMENT OINTMENT 2% W/W HOE PHARMACEUTICALS<br />

SDN. BHD<br />

FOBANCORT OINTMENT N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

FOBANCORT CREAM N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

FOBANCORT CREAM N/A HOE PHARMACEUTICALS<br />

SDN BHD<br />

FOBANCORT OINTMENT N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

FOBANCORT OINTMENT OINTMENT N/A HOE PHARMACEUTICALS<br />

SDN. BHD<br />

UNITED KINGDOM<br />

TURKEY<br />

IRELAND<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

FOLIC ACID TABLETS 5MG REMEDICA LTD CYPRUS<br />

FOLIC ACID TABLETS 5MG PHARMAMED LTD. MALTA<br />

FOLIC ACID BP 5MG TABLET 5MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

FOLIC ACID TABLETS TABLET 5MG CAMDEN INDUSTRIES (M)<br />

SDN. BHD<br />

FOLIC ACID TABLETS BP 5MG TABLETS 5MG CP PHARMACEUTICALS<br />

LTD.<br />

FOLIC ACID TABLETS BP 5MG TABLET 5MG CP PHARMACEUTICALS<br />

LTD<br />

FOLIFER PROLONGED RELEASE<br />

TABLET<br />

FOLIFER PROLONGED RELEASE<br />

TABLET<br />

FORADIL POWDER CAPS. FOR<br />

INHAL.<br />

NA LABORATORIOS BIAL —<br />

PORTELA & CA, S.A.<br />

NA LABORATORIOS BIAL —<br />

PORTELA & CA, S.A.<br />

12MCG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

UNITED KINGDOM<br />

MALAYSIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

PORTUGAL<br />

PORTUGAL<br />

SWITZERLAND


EN<br />

566 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FORADIL POWDER FOR<br />

INHALATION<br />

12MCG NOVARTIS PHARMA<br />

S.P.A.<br />

FORAL LOZENGE N/A DR.GROSSMANN AG<br />

PHARMACA<br />

FORANE CONC. FOR INHALATION<br />

SOL.<br />

99.9% W/W ABBOTT LABORATORIES<br />

LIMITED<br />

ITALY<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

FORCEVAL CAPSULES CAPSULE N/A UNIGREG LIMITED UNITED KINGDOM<br />

FORCEVAL JUNIOR CAPSULES CAPSULE N/A UNIGREG LIMITED UNITED KINGDOM<br />

FORCEVAL PROTEIN POWDER POWDER FOR ORAL<br />

SOLUTION<br />

N/A UNIGREG LIMITED UNITED KINGDOM<br />

FORCID SOLUTAB TABLETS 125/31,25 YAMANOUCHI PHARMA<br />

B.V.<br />

FORCID SOLUTAB TABLETS 250/62,50 YAMANOUCHI PHARMA<br />

B.V.<br />

FORCID SOLUTAB TABLETS 375/93,75 YAMANOUCHI PHARMA<br />

B.V.<br />

FORCID SOLUTAB TABLETS 500/125 YAMANOUCHI PHARMA<br />

B.V.<br />

FORECOX TABLETS N/A MALCEODS<br />

PHARMACEUTICALS LTD<br />

FORECOX-TRAC TABLET N/A MACLEODS<br />

PHARMACEUTICALS LTD<br />

FORMOMICIN OPTHALMIC DROPS N/A FARMIGEA SPA ITALY<br />

FORMOMICIN OPHTHALMIC OINTMENT N/A FARMIGEA SPA ITALY<br />

FORSEF 1G IM POWDER F/SOLUTION F/<br />

INJ<br />

FORSEF 1G IV POWDER F/SOLUTION F/<br />

INJ<br />

1G BILIM ILAC SANAYII VE<br />

TICARET A.S<br />

1G BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

FORTOVASE CAPSULE 200MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

FORTRAL CAPSULES 50MG CAPSULE 50MG SANOFI WINTHROP<br />

LIMITED<br />

FORTRAL INJECTION 30MG/ML SOLUTION FOR<br />

INJECTION<br />

FORTUM 1G/3ML POWDER AND SOL FOR<br />

INJ.<br />

FORTUM 500MG/1.5ML POWDER AND SOL FOR<br />

INJ.<br />

3.947% W/V SANOFI WINTHROP<br />

LIMITED<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

INDIA<br />

INDIA<br />

TURKEY<br />

TURKEY<br />

1164MG GLAXOSMITHKLINE S.P.A ITALY<br />

582MG GLAXOSMITHKLINE S.P.A ITALY<br />

FORTUM FOR INJECTION POWDER FOR INJECTION 1G GLAXO OPERATIONS UK<br />

LIMITED<br />

FORTUM FOR INJECTION POWDER FOR INJECTION 500MG GLAXO OPERATIONS UK<br />

LIMITED<br />

FORTUM INJECTION 1G POWDER FOR INJECTION 1G GLAXO OPERATIONS UK<br />

LTD<br />

FORTUM INJECTION 250MG POWDER FOR INJECTION 250MG GLAXO OPERATIONS UK<br />

LTD<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FORTUM INJECTION 2G POWDER FOR INJECTION 2G GLAXO OPERATIONS UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 567<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FORTUM INJECTION 500MG POWDER FOR INJECTION 500MG GLAXO OPERATIONS UK<br />

LTD<br />

FORTZAAR 100/25MG TABLETS 100/25MG MERCK SHARP & DOHME<br />

B.V.<br />

FOSAMAX 10MG TABLET 10MG MERCK SHARP & DOHME<br />

B.V.<br />

FOSAMAX, ONCE WEEKLY TABLETS 70MG MERCK SHARP & DOHME<br />

LTD.<br />

FRAGMIN SOLUTION FOR<br />

INJECTION<br />

FRAGMIN SOLUTION FOR<br />

INJECTION<br />

FRAGMIN SOLUTION FOR<br />

INJECTION<br />

FRAGMIN SOLUTION FOR<br />

INJECTION<br />

FRAGMIN SOLUTION FOR<br />

INJECTION<br />

FRAGMIN SOLUTION FOR<br />

INJECTION<br />

FRAGMIN 2500IU (ANTI-XA)/ML SOLUTION FOR<br />

INJECTION<br />

FRAGMIN 2500IU/0.2ML SOLUTION FOR<br />

INJECTION<br />

FRAGMIN 5000IU/0.2ML SOLUTION FOR<br />

INJECTION<br />

FRAXIPARINE 2850 UI AXA/0.3ML SOLUTION FOR<br />

INJECTION<br />

25,000IU PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

2500IU/ML PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

10000IU/1ML PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

NETHERLANDS<br />

UNITED KINGDOM<br />

SWEDEN<br />

SWEDEN<br />

SWEDEN<br />

2500IU/ML PHARMACIA NV/SA BELGIUM<br />

12 500IU/ML PHARMACIA SVERIGE AB SWEDEN<br />

7500IU/0.3ML PHARMACIA NV/SA BELGIUM<br />

2500IU/ML PHARMACIA NV/SA BELGIUM<br />

2500IU/02ML PHARMACIA NV/SA BELGIUM<br />

5000IU/0.2ML PHARMACIA NV/SA BELGIUM<br />

2850 IU/0.3ML SANOFI WINTHROP FRANCE<br />

FRAXIPARINE 3800 IU AXA/0.4ML INJ. SOLUTION 3800IU SANOFI SYNTHALABO<br />

FRANCE<br />

FRAXIPARINE 5700 UI AXA/0.6ML SOLUTION FOR<br />

INJECTION<br />

FRAXIPARINE 7600 UI/AXA/0.8ML SOLUTION FOR<br />

INJECTION<br />

FRAXIPARINE FORTE INJECTABLE SOLUTION<br />

(PFS)<br />

FRAXIPARINE FORTE INJECTABLE SOLUTION<br />

(PFS)<br />

FRAXIPARINE FORTE INJECTABLE SOLUTION<br />

(PFS)<br />

FRANCE<br />

5700 IU/0.6ML SANOFI WINTHROP FRANCE<br />

7600 IU/0.8ML SANOFI WINTHROP FRANCE<br />

11400 IU/0.6ML SANOFI WINTHROP FRANCE<br />

15200 IU/0.8ML SANOFI WINTHROP FRANCE<br />

19000IU/1ML SANOFI WINTHROP FRANCE<br />

FRIARS BALSAM BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM<br />

FROMILID FILM-COATED TABLET 250MG KRKA, D.D., NOVO<br />

MESTO<br />

FROXIME TABLETS 250MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

FROXIME SUSPENSION 125MG/5ML DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT<br />

SLOVENIA<br />

JORDAN<br />

JORDAN


EN<br />

568 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FRU-CO TABLETS N/A NORTON HEALTHCARE<br />

LIMITED<br />

FRUMIL TABLET N/A HELIOS HEALTHCARE<br />

LIMITED<br />

FRUMIL TABLET N/A HELIOS HEALTHCARE<br />

LIMITED<br />

FRUSEMIDE TABLET 40MG GENERICS (UK) LIMITED<br />

—UK<br />

FRUSEMIDE INJECTION BP SOLUTION FOR<br />

INJECTION<br />

50MG/ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

FRUSEMIDE BP TABLET 40MG CP PHARMACEUTICALS<br />

LIMITED<br />

FRUSEMIDE INJ MINIJET AQUEOUS SOLUTION 10MG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

FRUSEMIDE INJECTION SOLUTION FOR<br />

INJECTION<br />

FRUSEMIDE INJECTION BP SOLUTION FOR<br />

INJECTION<br />

FRUSEMIDE INJECTION BP SOLUTION FOR<br />

INJECTION<br />

FRUSEMIDE INJECTION BP SOLUTION FOR<br />

INJECTION<br />

FRUSEMIDE INJECTION BP MINIJET SOLUTION FOR<br />

INJECTION<br />

20MG/2ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

250MG/25ML ANTIGEN<br />

PHARMACEUTICALS LTD<br />

20MG/2ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

250MG/ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

10MG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

FRUSEMIDE TABLET 40MG TABLET 40MG CAMDEN INDUSTRIES (M)<br />

SDN. BHD<br />

FRUSEMIDE TABLET BP 40MG<br />

AMEDOSIX<br />

UNITED KINGDOM<br />

GREECE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

UNITED KINGDOM<br />

MALAYSIA<br />

TABLET 40MG TABLETS (INDIA) LIMITED INDIA<br />

FRUSEMIDE TABLETS BP TABLET 40MG IPCA LABORATORIES<br />

LIMITED<br />

FRUSEMIDE TABLETS BP 40MG TABLET 40MG CP PHARMACEUTICALS<br />

LTD<br />

FUCICORT CREAM N/A LEO PHARMACEUTICAL<br />

PRODUCTS<br />

INDIA<br />

UNITED KINGDOM<br />

DENMARK<br />

FUCICORT CREAM N/A LEO PAKISTAN<br />

FUCICORT CREAM N/A LEO PAKISTAN<br />

FUCIDIN SUSPENSION 50MG/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

FUCIDIN CREAM 20MG/G LEO PHARMACEUTICAL<br />

PRODUCTS<br />

FUCIDIN GEL 20MG/G LEO PHARMACEUTICAL<br />

PRODUCTS<br />

FUCIDIN OINTMENT 20MG/G LEO PHARMACEUTICAL<br />

PRODUCTS<br />

DENMARK<br />

DENMARK<br />

DENMARK<br />

DENMARK


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 569<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FUCIDIN TABLETS 250MG LEO PHARMACEUTICAL<br />

PRODUCTS<br />

DENMARK<br />

FUCIDIN CREAM N/A LEO PAKISTAN<br />

FUCIDIN OINTMENT 20MG/G LEO PAKISTAN<br />

FUCIDIN CREAM 20MG/G LEO PAKISTAN<br />

FUCIDIN OINTMENT 20MG/G LEO PAKISTAN<br />

FUCIDIN H CREAM N/A LEO LABORATORIES<br />

LIMITED<br />

FUCIDIN H CREAM N/A LEO PHARMACEUTICAL<br />

PRODUCTS<br />

UNITED KINGDOM<br />

DENMARK<br />

FUCIDIN H CREAM CREAM NA LEO PAKISTAN<br />

FUCIDIN I.V. POWDER FOR INFUSION N/A LEO PHARMACEUTICAL<br />

PRODUCTS<br />

FUCIDIN INTERTULLE GAUZE INPREG. W/<br />

OINTMENT<br />

FUCIDIN INTERTULLE GAUZE IMP. WITH<br />

OINTMENT<br />

20MG/100CM2 LEO PHARMACEUTICAL<br />

PRODUCTS<br />

30MG/100CM2 LEO PHARMACEUTICAL<br />

PRODUCTS<br />

DENMARK<br />

DENMARK<br />

DENMARK<br />

FUCIDIN-H CREAM N/A LEO PAKISTAN<br />

FUCITHALMIC VISCOUS EYE DROPS 10MG/G LEO PHARMACEUTICAL<br />

PRODUCTS<br />

DENMARK<br />

FUCITHALMIC VISCOUS EYE DROPS 10MG/G LEO PAKISTAN<br />

FUCITHALMIC DROPS EYE DROPS 1%W/W LEO PAKISTAN<br />

FUGENTIN TABLET N/A ELPEN S.A. GREECE<br />

FUGENTIN POWD. ORAL<br />

SUSPENSION<br />

FUGENTIN POWD. FOR ORAL<br />

SUSPENSION<br />

N/A ELPEN S.A. GREECE<br />

N/A ELPEN PHARM. CO. INC. GREECE<br />

FULCIN TABLET 125MG ZENECA LIMITED UNITED KINGDOM<br />

FULCIN TABLET 500MG ZENECA LIMITED UNITED KINGDOM<br />

FULCIN ORAL SUSPENSION 2.5%W/V ZENECA LIMITED UNITED KINGDOM<br />

FULL MARKS LOTION TOPICAL SOLUTION 0.2% W/V SETON PRODUCTS<br />

LIMITED<br />

UNITED KINGDOM<br />

FUNGILIN LOZENGES 10MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

FUNGILIN ORAL TABLETS 100MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

FUNGILIN ORAL SUSPENSION 100MG/ML E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

FUNGO POWDER POWDER 2% W/W EGO PHARMACEUTICALS AUSTRALIA<br />

FUNGO SOLUTION SOLUTION 2% W/W EGO PHARMACEUTICALS AUSTRALIA<br />

FUNGO SOOTHING BALM BALM N/A EGO PHARMACEUTICALS AUSTRALIA<br />

FUNGO VAGINAL CREAM CREAM 2% W/W EGO PHARMACEUTICALS AUSTRALIA<br />

FUNGOCORT CREAM N/A EGO PHARMACEUTICALS AUSTRALIA<br />

FUNGOTOX CREAM 10MG/G MEPHA PHARMA AG SWITZERLAND


EN<br />

570 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

FURANTOINA TABLET 50MG J.URIACH & CIA. S.A. SPAIN<br />

FUROSEMIDE SOLUTION FOR<br />

INJECTION<br />

FUROSEMIDE SOLUTION FOR<br />

INJECTION<br />

FUROSEMIDE INJECTION USP SOLUTION FOR<br />

INJECTION<br />

FUROSEMIDE/FRUSEMIDE (FUSID)<br />

TABLETS<br />

FUROSEMID-SLOVAKOFARMA<br />

TABLETS<br />

FYBOGEL LEMON GRANULES FOR ORAL<br />

SOLN.<br />

10MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

20MG/2ML PHARMAMED<br />

PARENTERALS LTD.<br />

MALTA<br />

10MG/1ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

TABLET 40MG TEVA PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

TABLET 40 MG SLOVAKOFARMA A.S.<br />

HLOHOVEC<br />

3.5G RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

FYBOGEL LEMON GRANULES F/ORAL SOL. 3.5G RECKITT BENCKISER<br />

HEALTHCARE(UK)<br />

LIMITED<br />

FYBOGEL MEBEVERINE EFF.GRANULES F/ORAL<br />

SUSP.<br />

FYBOGEL ORANGE EFFERVESCENT<br />

GRANULES<br />

N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

3.5G RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

FYBOGEL ORANGE EFF.GRANULES 3.5GM RECKITT BENCKISER<br />

HEATHCARE(UK)<br />

LIMITED<br />

G.P.O. (4% ALBUMIN) SOLUTION FOR<br />

INFUSION<br />

ISRAEL<br />

SLOVAK REPUBLIC<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

40G/L CLB NETHERLANDS<br />

GADIN TABLETS 150MG UNIMED<br />

PHARMACEUTICALS INC.<br />

GADIN (RANITIDINE<br />

HYDROCHLORIDE)<br />

SOLUTION FOR<br />

INJECTION<br />

GADOVIST 1.0MMOL/ML SOLUTION FOR<br />

INJECTION<br />

50MG/2ML UNIMED<br />

PHARMACEUTICALS INC<br />

KOREA REPUBLIC<br />

KOREA REPUBLIC<br />

1.0MMOL/ML SCHERING AG GERMANY<br />

GALENAMOX CAPSULES 250MG BP GALEN LIMITED UNITED KINGDOM<br />

GALENAMOX GRANULES FOR ORAL<br />

SOL.<br />

GALENAMOX GRANULES FOR ORAL<br />

SOL.<br />

125MG/5ML GALEN LIMITED UNITED KINGDOM<br />

250MG/5ML GALEN LIMITED UNITED KINGDOM<br />

GALENOMOX CAPSULES 500MG BP GALEN LIMITED UNITED KINGDOM<br />

GALFER ORAL SOLUTION 140MG/5ML GALEN LIMITED UNITED KINGDOM<br />

GALFER FA CAPSULES N/A GALEN LIMITED UNITED KINGDOM<br />

GALLIUM CITRATE (67GA) SOLUTION FOR<br />

INJECTIONS<br />

37MBQ/ML NYCOMED AMERSHAM<br />

PLS<br />

UNITED KINGDOM<br />

GALPAMOL ORAL SUSPENSION 120MG/5ML HEALTHY IDEAS LIMITED UNITED KINGDOM<br />

GALPHARM HAYFEVER AND<br />

ALLERGY RELIEF<br />

GALPROFEN IBUPROFEN COLD<br />

AND FLU<br />

FILM COATED TABLET 10MG APPROVED<br />

PRESCRIPTION SERVICES<br />

LIMITED<br />

COATED TABLET 200MG GALPHARM<br />

HEALTHCARE LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 571<br />

Trade Name Dosage Form Dose MA Holder Country<br />

GALPROFEN LONG LASTING<br />

IBUPROFEN CAPSULE<br />

MODIFIED RELEASE<br />

CAPSULE<br />

200MG HEALTHY IDEAS LIMITED UNITED KINGDOM<br />

GAMALATE B6 COATED TABLETS N/A LABORATORIOS NOVAG,<br />

S.A.<br />

GAMALATE B6 SOLUTION N/A LABORATORIOS NOVAG,<br />

S.A.<br />

GAMIMUNE N, 10% SOLUTION FOR IV<br />

INJECTION<br />

GAMIMUNE N, 5% SOLUTION FOR IV<br />

INJECTION<br />

GAMMAGLOBULIN PHARMACIA SOLUTION FOR<br />

INJECTION<br />

GAMMAGLOBULIN PHARMACIA SOLUTION FOR<br />

INJECTION<br />

10% W/V BAYER CORPORATION,<br />

PHARMACEUTICAL<br />

DIVISION<br />

5% W/V BAYER CORPORATION,<br />

PHARMACEUTICAL<br />

DIVISION<br />

165MG/1ML PHARMACIA & UPJOHN<br />

AB<br />

SPAIN<br />

SPAIN<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

SWEDEN<br />

165MG/ML BIOVITRUM AB SWEDEN<br />

GAMMONATIV POWDER FOR INFUSION (I+II) 2.5G PHARMACIA & UPJOHN<br />

AB<br />

GAMMONATIV POWDER FOR INFUSION (I+II) 5G PHARMACIA & UPJOHN<br />

AB<br />

GAMMONATIV POWDER AND<br />

SOLVENT<br />

SWEDEN<br />

SWEDEN<br />

POWDER AND SOLVENT 2.5G BIOVITRUM SWEDEN<br />

GANAZOLO VAGINAL CREAM 1% W/W ISTITUTO GANASSINI<br />

S.P.A DI RICERCHE<br />

BIOCHIMICHE<br />

GANAZOLO VAGINAL OVULES 150MG ISTITUTO GANASSINI<br />

S.P.A. DI RICERCHE<br />

BIOCHIMICHE<br />

GARAMYCIN OINTMENT 0.1% W/W S-P CANADA CANADA<br />

GARAMYCIN 0.1% CREAM 0.1% W/W S-P CANADA CANADA<br />

GARASONE EYE OINTMENT N/A SCHERING-PLOUGH<br />

NV/SA<br />

ITALY<br />

ITALY<br />

BELGIUM<br />

GARASONE EYE/EAR DROPS N/A SCHERING-PLOUGH S.A. BELGIUM<br />

GASTROBID CONTINUS TABLETS<br />

15MG<br />

MODIFIED RELEASE<br />

TABLETS<br />

15MG NAPP LABORATORIES<br />

LIMITED<br />

GASTROFAIT TABLETS 1G EGYPTIAN<br />

INTERNATIONAL<br />

PHARMACEUTICAL<br />

INDUSTRIES CO.<br />

GASTROGRAFIN SOLUTION N/A SCHERING ESPANA, S.A. SPAIN<br />

GASTRONERTON TABLET 8.92MG DOLORGIET GMBH & CO.<br />

KG<br />

GASTRONERTON TABLET 8.92MG/TABLET DOLORGEIT GMBH & CO<br />

KG<br />

GASTRONERTON SYRUP SOLUTION 116.2MG/100ML DOLORGIET GMBH & CO.<br />

KG<br />

GASTROPRIDE SUSPENSION 5MG/5ML DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

UNITED KINGDOM<br />

EGYPT<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

JORDAN


EN<br />

572 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

GAVISCON LIQUID N/A RECKITT & COLMAN PAKISTAN<br />

GAVISCON ADVANCE ORAL SUSPENSION N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

GAVISCON INFANT POWDER FOR ORAL<br />

SOLUTION<br />

N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

GAVISCON LIQUID LIQUID N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GAVISCON LIQUID LIQUID NA RECKITT & BENCKISER PAKISTAN<br />

GAVISCON LIQUID PEPPERMINT ORAL SUSPENSION N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

GAVISCON LIQUID SACHETS ORAL SUSPENSION N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

GAVISCON PEPPERMINT<br />

FLAVOUR<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CHEWABLE TABLET N/A RECKITT & COLMAN PAKISTAN<br />

GAVISCON TABLETS TABLET N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

UNITED KINGDOM<br />

GAVISCON TABLETS TABLETS NA RECKITT & BENCKISER PAKISTAN<br />

GAVISCON TOFFEE FLAVOUR CHEWABLE TABLET N/A RECKITT & COLMAN PAKISTAN<br />

GEE'S LINCTUS BP/SQUILL OPIATE<br />

LINQTUS<br />

ORAL SOLUTION N/A LCM LTD UNITED KINGDOM<br />

GELAFUNDIN INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

GERMANY<br />

GELCOTAR LIQUID SHAMPOO N/A QUINODERM LIMITED UNITED KINGDOM<br />

GEL-LARMES OPHTHALMIC GEL 0.3G / 100G LABORATOIRES THEA FRANCE<br />

GELOFUSINE SOLUTION FOR<br />

INFUSION<br />

4% W/V B.BRAUN MELSUNGEN<br />

AG<br />

GELOMYRTOL CAPSULES 120MG G. POHL-BOSKAMP<br />

GMBH & CO<br />

GELOMYRTOL FORTE CAPSULE 300MG G. POHL-BOSKAMP<br />

GMBH & CO<br />

GEMZAR POWDER FOR IV<br />

INJECTION<br />

GEMZAR POWDER FOR IV<br />

INJECTION<br />

200MG LABORATOIRES LILLY<br />

FRANCE<br />

1000MG LABORATOIRES LILLY<br />

FRANCE S.A.<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

FRANCE<br />

FRANCE<br />

GENELAC ORAL SOLUTION 100%W/V GENERICS (UK) LTD. UNITED KINGDOM<br />

GENOTROPIN (I + II) 16IU POWDER FOR INJECTION N/A PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

GENOTROPIN (I + II) 36IU POWDER FOR INJECTION N/A PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

GENOTROPIN, POWDER AND<br />

SOLVENT<br />

SWEDEN<br />

SWEDEN<br />

POWDER AND SOLVENT 16IU(5.3MG) PHARMACIA SVERIGE AB SWEDEN<br />

GENOVOX FILM COATED TABLETS 30MG KLEVA LTD. GREECE<br />

GENOVOX FILM COATED TABLETS 30MG KLEVA LIMITED GREECE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 573<br />

Trade Name Dosage Form Dose MA Holder Country<br />

GENTADAR EYE/EAR DROPS N/A DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

JORDAN<br />

GENTAMED 80MG/2ML LIQUID FOR INJECTION 80MG/2ML MEDOCHEMIE LTD CYPRUS<br />

GENTAMICIN SOLUTION FOR<br />

INJECTION<br />

80MG/2ML KRKA, D.D., NOVO<br />

MESTO<br />

GENTAMICIN INJECTION IP 40MG CIPLA LTD — INDIA INDIA<br />

GENTAMICIN - POS EYEDROPS EYE DROPS N/A URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

AND CO KG —<br />

GERMANY<br />

GENTAMICIN SULFATE SOLUTION FOR<br />

INJECTION<br />

GENTAMICIN SULFATE INJECTION<br />

USP<br />

GENTAMICIN SULPHATE SOL. FOR<br />

INJECTION<br />

80MG/2ML PHARMAMED<br />

PARENTERALS LTD.<br />

SLOVENIA<br />

GERMANY<br />

MALTA<br />

SOLUTION F/INJECTION 40MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

SOLUTION FOR<br />

INJECTION<br />

GENTAMICINE (ESSEX GENTA) SOLUTION FOR<br />

INJECTION<br />

40MG/ML TABLETS (INDIA) LIMITED INDIA<br />

80MG/2ML SCHERING-PLOUGH S.A. BELGIUM<br />

GENTAMYCIN INJECTION 80MG/2ML WAN WEI YAO ZHUNZI CHINA<br />

GENTAMYCIN INJECTION SOLUTION FOR<br />

INJECTION<br />

80MG/2ML FAULDING<br />

PHARMACEUTICALS<br />

GENTAMYTREX OPHTHALMIC OINTMENT 3MG/1G DR. GERHARD MANN<br />

CHEM-PHARM FABRIK<br />

GMBH<br />

GENTAMYTREX IN DER OPHTIOLE EYE DROPS 5MG/ML DR. GERHARD MANN,<br />

CHEM.-PHARM.FABRIK<br />

GMBH<br />

GENTATRIM OINTMENT 0.1%W/W TRIMA ISRAEL<br />

PHARMACEUTICAL<br />

PRODUCTS LIMITED<br />

GENTIBIOPTAL EYE DROPS 441MG/100ML FARMILA FARMCEUTICI<br />

MILANO S.P.A.<br />

GENTRAN 70 INTRAVENOUS<br />

INFUSION<br />

SOLUTION FOR<br />

INJECTION<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

GEOERYTHCIN TABLET 250MG GEOFMAN<br />

PHARMACEUTICALS<br />

GEOMOXIN SUSPENSION 125MG/5ML GEOFMAN<br />

PHARMACEUTICALS<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

ISRAEL<br />

ITALY<br />

UNITED KINGDOM<br />

PAKISTAN<br />

PAKISTAN<br />

GEOMYCIN/GARAMYCIN EYE/EAR DROPS 3MG/ML SCHERING-PLOUGH S.A. BELGIUM<br />

GERARD BLUE FLAG ROOT<br />

COMPOUND TABLETS<br />

GERARD BUCHU COMPOUND<br />

TABLETS<br />

GERARD HELONIAS COMPOUND<br />

TABLETS<br />

TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

GERARD HOUSE SOMNUS COATED TABLET N/A CATHAY OF<br />

BOURNEMOUTH LIMITED<br />

UNITED KINGDOM


EN<br />

574 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

GERARD HOUSE CATARRH EEZE TABLET N/A PETER BLACK<br />

HEALTHCARE<br />

GERARD HOUSE ECHINACEA +<br />

GARLIC TABLETS<br />

GERARD HOUSE REUMALEX<br />

TABLETS<br />

COATED TABLET N/A CATHAY OF<br />

BOURNEMOUTH LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

GERARD HOUSE SERENITY COATED TABLET N/A CATHAY OF<br />

BOURNEMOUTH LIMITED<br />

UNITED KINGDOM<br />

GERARD HOUSE SLIMMERS AID TABLETS N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

GERARD HOUSE WATER RELIEF<br />

TABLETS<br />

COATED TABLETS N/A PETER BLACK<br />

HEALTHCARE LIMITED<br />

UNITED KINGDOM<br />

GERARD KELP TABLETS 360MG TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

GERARD PAPAYA PLUS TABLETS COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

GERARD SLIPPERY ELM TABLETS TABLET 400MG GERARD HOUSE LIMITED UNITED KINGDOM<br />

GERIAVIT PHARMATON<br />

(PHARMATON CAPSULES)<br />

CAPSULE N/A PHARMATON SA SWITZERLAND<br />

GERMACID OINTMENT 2% W/W RAZA MANUFACTURING<br />

BERHAD<br />

GERMOLENE ANTISEPTIC<br />

OINTMENT<br />

OINTMENT N/A BAYER PLC T/A BAYER<br />

PLC CONSUMER<br />

DIVISION<br />

GERMOLOIDS OINTMENT N/A BAYERPLC/BAYERPLC<br />

CONSUMER CARE<br />

DIVISION<br />

GERMOLOIDS COMPLETE<br />

SUPPOSITORY<br />

SUPPOSITORY N/A BAYER PLC T/A BAYER<br />

PLC CONSUMER CARE<br />

DIVISION<br />

GERMOLOIDS SUPPOSITORIES SUPPOSITORY N/A BAYER PLCT/A BAYER<br />

PLC CONSUMER CARE<br />

DIVISION<br />

GESTONE 100MG/2ML SOLUTION FOR<br />

INJECTION<br />

GESTONE 25MG/ML SOLUTION FOR<br />

INJECTION<br />

GESTONE 50MG/ML SOLUTION FOR<br />

INJECTION<br />

100MG/2ML FERRING<br />

PHARMACEUTICALS<br />

LIMITED<br />

25MG/ML FERRING<br />

PHARMACEUTICALS<br />

LIMITED<br />

50MG/ML FERRING<br />

PHARMACEUTICALS<br />

LIMITED<br />

GF-125 TABLETS 125MG CAMDEN INDUSTRIES (M)<br />

SDN. BHD<br />

GINCOSAN HARD GELATINE<br />

CAPSULES<br />

MALAYSIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

N/A PHARMATON SA SWITZERLAND<br />

GINESAL VAGINAL SOLUTION NA FARMIGEA SPA ITALY<br />

GINGIVITOL N SOLUTION 8.78MG/1G HENNIG ARZNEIMITTEL<br />

GMBH & CO. KG<br />

GERMANY<br />

GINORECTOL FILM COATED TABLETS 250MG KLEVA LIMITED GREECE<br />

GINORECTOL FILM COATED TABLETS 500MG KLEVA LIMITED GREECE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 575<br />

Trade Name Dosage Form Dose MA Holder Country<br />

GINSANA CAPSULE 100MG BOEHRINGER INGELHEIM<br />

LIMITED<br />

GIVALEX MOUTH WASH N/A LABORATOIRES<br />

NORGINE PHARMA<br />

GIVALEX MOUTHWASH N/A LABORATOIRES<br />

NORGINE PHARMA<br />

GIVALEX MOUTHWASH N/A LABORATOIRES<br />

NORGINE PHARMA<br />

GLABINOL TABLET 5MG GEOFMAN<br />

PHARMACEUTICALS<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

PAKISTAN<br />

GLADLAX TABLETS TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

GLIBENCLAMIDE TABLETS 2.5MG NORTON HEALTHCARE<br />

LIMITED<br />

GLIBENCLAMIDE TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

GLIBENCLAMIDE TABLETS 5MG PHARMAMED LTD. MALTA<br />

GLIBENCLAMIDE TABLETS 5MG EGYPTIAN<br />

INTERNATIONAL<br />

PHARMACEUTICAL<br />

INDUSTRIES CO (EIPICO)<br />

GLIBENCLAMIDE TABLETS BP<br />

2.5MG<br />

GLIBENCLAMIDE TABLETS BP<br />

2.5MG<br />

GLIBENCLAMIDE TABLETS BP<br />

5MG<br />

GLIBENCLAMIDE TABLETS BP<br />

5MG<br />

TABLETS 2.5MG CP PHARMACEUTICALS<br />

LTD.<br />

TABLET 2.5MG CP PHARMACEUTICALS<br />

LTD<br />

TABLETS 5MG CP PHARMACEUTICALS<br />

LTD.<br />

TABLET 5MG CP PHARMACEUTICALS<br />

LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

EGYPT<br />

GLIBESYN 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

GLIBOMET FILM-COATED TABLETS NA LABORATORI GUIDOTTI<br />

SPA<br />

GLICEROLO SUPPOSITORIES 2500MG PIETRASANTA PHARMA<br />

S.R.L.<br />

GLICEROLO SUPPOSITORIES 2250MG LABORATORIO CHIMICO<br />

FARMACEUTICO A.<br />

SELLA S.R.L.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GLIMICRON 80MG TABLET 80MG HOVID SDN. BHD MALAYSIA<br />

GLITISOL TABLETS 5MG REMEDICA LTD CYPRUS<br />

GLIVEC HARD CAPSULES 50MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

GLIVEC HARD CAPSULES 100MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

GLIVEC HARD CAPSULES 50MG NOVARTIS EUROPHARM<br />

LIMITED<br />

GLIVEC HARD CAPSULES 100MG NOVARTIS EUROPHARM<br />

LIMITED<br />

ITALY<br />

ITALY<br />

ITALY<br />

SWITZERLAND<br />

SWITZERLAND<br />

GLORYFEN DR.PD.INJ. 1G/VIAL HELP A.B.E.E. GREECE<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY


EN<br />

576 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

GLUCAGEN 1MG HYPOKIT<br />

INJECTION<br />

POWDER F/INJ AND<br />

SOLVENT<br />

GLUCAGEN INJECTION POWDER F/INJ AND<br />

SOLVENT<br />

1MG/1ML NOVO DORDISK A/S DENMARK<br />

1MG/1ML NOVO NORDISK A/S DENMARK<br />

GLUCOBAY 100 TABLET 100MG BAYER VITAL GMBH &<br />

CO. KG<br />

GERMANY<br />

GLUCOBAY 100MG TABLETS 100MG BAYER PAKISTAN<br />

GLUCOBAY 50 TABLET 50MG BAYER VITAL GMBH &<br />

CO. KG<br />

GERMANY<br />

GLUCOBAY 50MG TABLET 50MG BAYER PAKISTAN<br />

GLUCOMET FILM COATED TABLETS 500MG,850MG DOUGLAS<br />

PHARMACEUTICALS<br />

LIMITED<br />

NEW ZEALAND<br />

GLUCOPHAGE 500MG FILM-COATED TABLET 500MG LIPHA SANTE FRANCE<br />

GLUCOPHAGE 850MG FILM-COATED TABLET 850MG LIPHA SANTE FRANCE<br />

GLUCOSE SOLUTION FOR<br />

INJECTION<br />

GLUCOSE SOLUTION FOR<br />

INJECTION<br />

GLUCOSE 20%W/V INTRAVENOUS<br />

INFUSION BP<br />

GLUCOSE 50% W/V<br />

INTRAVENOUS INFUSION<br />

GLUCOSE INJECTION MINIJET<br />

50%W/V<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

20% W/VBP GALEN RESEARCH<br />

LABORATORIES LIIMITED<br />

50% W/V BP IVEX PHARMACEUTICALS<br />

LIMITED<br />

20%W/V GALEN RESEARCH<br />

LABORATORIES<br />

50%W/V IVEX PHARMACEUTICALS<br />

LIMITED<br />

AQUEOUS SOLUTION 500MG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

GLUCOSE INJECTION BP MINIJET SOUTION FOR INJECTION 50%W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

GLUCOSE INTRAVENOUS<br />

INFUSION<br />

GLUCOSE INTRAVENOUS<br />

INFUSION<br />

GLUCOSE INTRAVENOUS<br />

INFUSION<br />

SOLUTION FOR<br />

INFUSION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

GLUCOSE IV INFUSION SOLUTION FOR<br />

INFUSION<br />

50%W/V BAXTER HEALTHCARE<br />

LIMITED<br />

10%W/V BAXTER HEALTHCARE<br />

LIMITED<br />

20%W/V BAXTER HEALTHCARE<br />

LIMITED<br />

5%W/V BAXTER HEALTHCARE<br />

LIMITED<br />

GLUMET-500 TABLET 500MG CIPLA LIMITED INDIA<br />

GLYCERIN (GLYCEROL BP) ORAL SOLUTION 100% V/V WILLIAM RANSOM &<br />

SON PLC<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GLYCERIN BP ORAL SOLUTION 100% V/V LVM LTD UNITED KINGDOM<br />

GLYCERIN BP ORAL SOLUTION ORAL SOLUTION 100%V/V LCM LIMITED UNITED KINGDOM<br />

GLYCERIN SUPPOSITORIES BP 1G<br />

INFANTS'<br />

GLYCERIN, LEMON, HONEY WITH<br />

GLUCOSE LINC<br />

SUPPOSITORY 70%W/W THORNTON & ROSS LTD UNITED KINGDOM<br />

ORAL SOLUTION N/A LCM LTD UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 577<br />

Trade Name Dosage Form Dose MA Holder Country<br />

GLYCERINE SUPP. B.P.2G<br />

MOULD-CHILDREN'S<br />

SUPPOSITORY 70%W/W THORNTON & ROSS LTD UNITED KINGDOM<br />

GLYCERINE SUPPOSITORIES BP SUPPOSITORY 70%W/W MARTINDALE<br />

PHARMACEUTICALS LTD<br />

GLYCERINE SUPPOSITORIES BP 4G<br />

ADULT SIZE<br />

UNITED KINGDOM<br />

SUPPOSITORY 70%W/W LCM LTD UNITED KINGDOM<br />

GLYCERYL TRINITRATE BP TABLET 500MCG A.H. COX & COMPANY<br />

LIMITED<br />

GLYCOMIN TABLET 5MG PHARMACARE LIMITED<br />

— SOUTH AFRICA<br />

UNITED KINGDOM<br />

SOUTH AFRICA<br />

GLYFORMIN TABLETS 500MG REMEDICA LTD. CYPRUS<br />

GLYTRIN SPRAY SUBLIGUAL SPRAY<br />

SOLUTION<br />

400 UG/AC BIOGLAN<br />

LABORATORIES LTD<br />

GLYVENOL SOFT CAPSULE 400MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

GLYVENOL 400 CAPSULES 400MG NOVARTIS PHARMA NV BELGIUM<br />

GNOSTOCARDIN TABLET 20MG BROS LTD GREECE<br />

GOANNA ARTHRITIS CREAM CREAM TUBE 100MG/G HERRON<br />

PHARMACEUTICALS PTY<br />

LTD<br />

GOCCE ODONTALGICHE DENTAL SOLUTION 4ML LABORATORIO CHIMICO<br />

FARMACEUTICO A.SELLA<br />

S.R.L<br />

AUSTRALIA<br />

GOLDEN EYE DROPS EYE DROPS 0.1% W/V TYPHARM LIMITED UNITED KINGDOM<br />

GOLDEN EYE OINTMENT 0.15% EYE OINTMENT 0.15% W/W TYPHARM LIMITED UNITED KINGDOM<br />

GOLDEN SEAL COMPOUND<br />

TABLETS<br />

GONAL-F SOLUTION FOR<br />

INJECTION<br />

GONAL-F SOLUTION FOR<br />

INJECTION<br />

GONAL-F SOLUTION FOR<br />

INJECTION<br />

GONAL-F SOLUTION FOR<br />

INJECTION<br />

ITALY<br />

COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

150 IU SERONO EUROPE<br />

LIMITED<br />

150 IU SERONO EUROPE<br />

LIMITED<br />

150 IU SERONO EUROPE<br />

LIMITED<br />

150 IU SERONO EUROPE<br />

LIMITED<br />

GONAL-F 75 POWDER FOR INJECTION 75 IU/3ML ARES SERONO (EUROPE)<br />

LIMITED<br />

GONAL-F 75IU INJECTABLE SOLUTION 75IU R-HFSH/ML LABORATOIRES SERONO<br />

SA<br />

GONASI HP SOLUTION FOR<br />

INJECTION<br />

GONASI HP SOLUTION FOR<br />

INJECTION<br />

GONIF DRY POWDER FOR<br />

INJECTION<br />

1000 IU A.M.S.A. S.R.L. ITALY<br />

5000 IU A.M.S.A. S.R.L. ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

750MG/VIAL KLEVA LIMITED GREECE<br />

GONNE BALM CREAM N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

UNITED KINGDOM


EN<br />

578 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

GRECOTENS GEL. EXT. US. GEL 0.5% GENEPHARM S.A. GREECE<br />

GREGODERM OINTMENT OINTMENT N/A UNIGREG LIMITED UNITED KINGDOM<br />

GRENIS-CIPRO TABLETS 250MG GENEPHARM S.A. GREECE<br />

GRENIS-CIPRO TABLETS 500MG GENEPHARM S.A. GREECE<br />

GRENOVIX TABLETS 30MG GENEPHARM S.A. GREECE<br />

GRENOVIX SYRUP 30MG/5ML GENEPHARM S.A. GREECE<br />

GRETHER'S BLACKCURRANT PASTILLES NA DOETSCH GRETHER AG SWITZERLAND<br />

GRETHER'S BLACKCURRANT<br />

SUGARLESS<br />

PASTILLES NS DOETSCH GRETHER AG SWITZERLAND<br />

GRETHER'S REDCURRANT PASTILLES NA DOETSCH GRETHER AG SWITZERLAND<br />

GRETHER'S REDCURRANT<br />

SUGARLESS WITH VITC<br />

GRETHER'S SWIISS ALP FRUITS<br />

SUGARLESS<br />

PASTILLES NA DOETSCH GRETHER AG SWITZERLAND<br />

PASTILLES NA DOETSCH GRETHER AG SWITZERLAND<br />

GRIPPOSTAD C CAPSULES N/A STADA ARZNEIMITEL AG GERMANY<br />

GRISEOFULVIN TABLETS 125MG PHARMAMED LTD. MALTA<br />

GRISEOFULVIN TABLETS 125MG REMEDICA CYPRUS<br />

GRISOVIN TABLET 125MG COATED TABLET 125MG GLAXO WELLCOME UK<br />

LTD T/A GLAXO LABS<br />

GRISOVIN TABLETS 500MG COATED TABLET 500MG GLAXO WELLCOME UK<br />

LTD<br />

GROFENAC EMULSION GEL 10MG/G DR.GROSSMANN AG<br />

PHARMACA<br />

GROFENAC AMPOULE 75MG DR.GROSSMANN AG<br />

PHARMACA<br />

GROFENAC SUPPOSITORY 100MG DR.GROSSMANN AG<br />

PHARMACA<br />

GROFENAC TABLET 50MG DR.GROSSMANN AG<br />

PHARMACA<br />

GROFENAC RETARD TABLET 100MG DR.GROSSMANN AG<br />

PHARMACA<br />

GROMAZOL SPRAY 10MG DR.GROSSMANN AG<br />

PHARMACA<br />

GROMAZOL CREAM 10MG DR.GROSSMANN AG<br />

PHARMACA<br />

GUANOR CHESTY COUGH<br />

LINCTUS<br />

ORAL SOLUTION N/A ROSEMONT<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

GUARINA GRANULES 100% W/W NORGINE LIMITED UNITED KINGDOM<br />

GUASTIL CAPSULE 50MG J.URIACH & CIA. S.A. SPAIN<br />

GUASTIL CHILDREN ORAL SUSPENSION 500MG/100ML J.URIACH & CIA. S.A. SPAIN<br />

GUTTALAX ORAL DROPS 0.75G/100ML BOEHRINGER INGELHEIM<br />

ITALIA S.P.A.<br />

ITALY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 579<br />

Trade Name Dosage Form Dose MA Holder Country<br />

GUTTALAX SOFT CAPSULE (PERLA) 1.5MG BOEHRINGER INGELHEIM<br />

ITALIA S.P.A.<br />

GYNERA COATED TABLET N/A SCHERING AG GERMANY<br />

GYNO CANESTEN 1 VAGINAL TABLET 0.5G BAYER VITAL GMBH &<br />

CO. KG<br />

GYNO CANESTEN 6 VAGINAL TABLET 0.1G BAYER VITAL GMBH &<br />

CO. KG<br />

ITALY<br />

GERMANY<br />

GERMANY<br />

GYNO-DAKTARIN VAGINAL CAPSULE 400MG JANSSEN-CILAG N.V. BELGIUM<br />

GYNO-DAKTARIN VAGINAL CAPSULE 1200MG JANSSEN-CILAG N.V. BELGIUM<br />

GYNO-DAKTARIN VAGINAL CREAM 20MG/G JANSSEN-CILAG N.V. BELGIUM<br />

GYNO-DAKTARIN CREAM N/A JANSSEN PAKISTAN<br />

GYNODEL TABLETS 2.5MG IL-KO ILAC VE KOZMETIK<br />

SAN.TIC.A.S<br />

GYNODEL TABLET 2.5MG IL-KO ILAC VE KOZMETIK<br />

SAN.A.S.<br />

TURKEY<br />

TURKEY<br />

GYNO-PEVARYL VAGINAL CREAM 10MG/G JANSSEN-CILAG AG SWITZERLAND<br />

GYNO-PEVARYL VAGINAL CREAM 1G/100G JANSSEN-CILAG NV BELGIUM<br />

GYNO-PEVARYL 150MG VAGINAL OVULE 150MG JANSSEN-CILAG AG SWITZERLAND<br />

GYNO-PEVARYL DEPOT VAGINAL OVULE 150MG JANSSEN-CILAG AG SWITZERLAND<br />

GYNO-TRAVOGEN OVULA PESSARY 600MG SCHERING SPA ITALY<br />

GYNO-TRAVOGEN OVULUM OVULUM FOR VAGINAL<br />

USE<br />

0.6G SCHERING AG GERMANY<br />

GYRABLOCK 400MG TABLET 400MG MEDOCHEMIE LTD CYPRUS<br />

HAEMOCORTIN OINTMENT N/A G.STREULI & CO. AG SWITZERLAND<br />

HAEMOCTIN SDH 1000 FRZ.DRD. SUBS.<br />

+DILUENT<br />

N/A BIOTEST PHARMA GMBH GERMANY<br />

HAEMOCTIN SDH 250 FRZ. DRD. SUBS. & DIL. N/A BIOTEST PHARMA GMBH GERMANY<br />

HAEMOCTIN SDH 500 FRZ. DRD. SUBS+DIL. N/A BIOTEST PHARMA GMBH GERMANY<br />

HAEMOLAN OINTMENT N/A G.STREULI & CO. AG SWITZERLAND<br />

HAIRGROW SOLUTION N/A DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO.<br />

LIMITED<br />

HAIRSCIENCE ANTI-DANDRUFF<br />

TREATMENT<br />

JORDAN<br />

SHAMPOO 20MG/G EGO PHARMACEUTICALS AUSTRALIA<br />

HALCION TABLETS 0.125MG PHARMACIA N.V. / S.A. BELGIUM<br />

HALCION TABLETS 0.25MG PHARMACIA N.V. / S.A. BELGIUM<br />

HALDOL 0.5MG TABLET 0.5MG JANSSEN-CILAG N.V. BELGIUM<br />

HALDOL 5MG TABLET 5MG JANSSEN-CILAG N.V. BELGIUM<br />

HALDOL 5MG/ML AMPOULES INJECTABLE SOLUTION 5MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

HALDOL DECANOAS 100MG/ML SOLUTION FOR<br />

INJECTION<br />

100MG/ML JANSSEN-CILAG N.V. BELGIUM


EN<br />

580 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

HALDOL DECANOAS 50MG/ML SOLUTION FOR<br />

INJECTION<br />

50MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

HALDOL DROPS DROPS 2MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

HALFAN 100MG/5ML ORAL SOLUTION 100MG/5ML LABORATOIRES SMITH<br />

KLINE & BEECHAM<br />

HALFAN 250MG TABLET 250MG LABORATOIRES SMITH<br />

KLINE & BEECHAM<br />

HALLS MENTHOLYPTUS<br />

BLACKCURRANT<br />

HALLS MENTHOLYPTUS EXTRA<br />

STRONG<br />

HALLS MENTHOLYPTUS HONEY<br />

AND LEMON<br />

HALLS MENTHOLYPTUS<br />

ORIGINAL<br />

HALLS MENTHOLYPTUS<br />

ORIGINAL S/F<br />

LOZENGE NA WARNER LAMBERT UK<br />

LIMITED T/A ADAMS<br />

LOZENGE NA WARNER LAMBERT UK<br />

LIMITED T/A ADAMS<br />

LOZENGE NA WARNER LAMBERT UK<br />

LIMITED T/A ADAMS<br />

LOZENGE NA WARNER LAMBERT UK<br />

LIMITED T/A ADAMS<br />

LOZENGE NA WARNER LAMBERT UK<br />

LIMITED T/A ADAMS<br />

HALOPER TABLETS 0.5MG CTS CHEMICAL<br />

INDUSTRIES LTD.<br />

HALOPER 0.5MG TABLETS TABLET 0.5MG CTS CHEMICAL<br />

INDUSTRIES LTD<br />

HALOPERIDOL TABLETS 1.5MG NORTON HEALTHCARE<br />

LIMITED<br />

HALOPERIDOL TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

HALOPERIDOL TABLETS 10MG NORTON HEALTHCARE<br />

LIMITED<br />

HALOPERIDOL TABLETS 20MG NORTON HEALTHCARE<br />

LIMITED<br />

HALOPERIDOL ORAL SOLUTION<br />

BP<br />

HALOPERIDOL ORAL SOLUTION<br />

BP 10MG/5ML<br />

HAMAMELIS WATER B.P.C.(DIST.<br />

WITCH HAZEL<br />

ORAL SOLUTION 10MG/5ML ROSEMONT<br />

PHARMACEUTICALS LTD.<br />

ORAL SOLUTION 10MG/5ML ROSEMONT<br />

PHARMACEUTICALS<br />

LIMITED<br />

TOPICAL SOLUTION 20.7% V/V WILLIAM RANSOM &<br />

SON PLC<br />

HAPPINOSE OINTMENT 0.3%W/W DIOMED DEVELOPMENTS<br />

LIMITED T/A DERMAL<br />

LABORATORIES<br />

HAVRIX 1440 SUSPENSION FOR<br />

INJECTION<br />

HAVRIX JUNIOR 720 SUSPENSION FOR<br />

INJECTION<br />

HAVRIX VACCINE (JUNIOR 360) SUSPENSION FOR<br />

INJECTION<br />

1440 ELISA U/ML SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

720 ELU/0.5ML SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

360 ELISA UNITS SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

HAY-CROM AQUEOUS EYE DROPS 2%W/V NORTON HEALTHCARE<br />

LIMITED<br />

HAY-CROM HAYFEVER EYE DROPS 2% W/V NORTON HEALTHCARE<br />

LIMITED<br />

FRANCE<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ISRAEL<br />

ISRAEL<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 581<br />

Trade Name Dosage Form Dose MA Holder Country<br />

HAYMINE MODIFIED RELEASE<br />

TABLETS<br />

HB-VAX DNA 10MCG VACCINE SUSPENSION FOR<br />

INJECTION<br />

HB-VAX DNA 5MCG VACCINE SUSPENSION FOR<br />

INJECTION<br />

N/A PHARMAX LIMITED UNITED KINGDOM<br />

10MCG MERCK SHARP & DOHME<br />

B.V.<br />

5MCG MERCK SHARP & DOHME<br />

B.V.<br />

HC45 HYDROCORTISONE CREAM CREAM 1%W/W CROOKES HEALTHCARE<br />

LIMITED<br />

HEALIT SKIN OINTMENT OINTMENT NA ATCO LABORATORIES<br />

(PVT) LTD<br />

NETHERLANDS<br />

NETHERLANDS<br />

UNITED KINGDOM<br />

PAKISTAN<br />

HEALTHY FEET CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM<br />

HEEMEX OINTMENT N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

HEMATOCIS KIT POWDER FOR INJECTION N/A CIS BIO INTERNATIONAL FRANCE<br />

HEMAX 1000 I.U. FREEZE DRIED PWR FOR<br />

INJ<br />

HEMAX 10000 IU FREEZE DRIED PWR FOR<br />

INJ<br />

HEMAX 2000 I.U FREEZE DRIED PWR FOR<br />

INJ<br />

HEMAX 3000 I.U FREEZE DRIED PWR FOR<br />

INJ<br />

HEMAX 4000 IU FREEZE DRIED PWR FOR<br />

INJ<br />

UNITED KINGDOM<br />

1000 I.U. INSTITUTO SIDUS S.A ARGENTINA<br />

10000 IU INSTITUTO SIDUS S.A ARGENTINA<br />

2000 IU INSTITUTO SIDUS S.A ARGENTINA<br />

3000 IU INSTITUTO SIDUS S.A ARGENTINA<br />

4000 IU INSTITUTO SIDUS S.A. ARGENTINA<br />

HEMI-DAONIL 2.5MG TABLET 2.5MG LABORATOIRES<br />

HOECHST<br />

FRANCE<br />

HEMINEVRIN CAPSULES 300MG ASTRA LAKEMEDEL AB SWEDEN<br />

HEMOCANE CREAM RECTAL CREAM N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

HEMOCANE RECTAL CREAM RECTAL CREAM N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

HEMOFIL M - AHF MONOCLONAL<br />

PURIFIED NOM.<br />

HEMOFIL M AHF (HUMAN) — SEE<br />

REMARKS<br />

HEMOFIL M AHF MONOCLONAL<br />

PURIFIED<br />

POWDER FOR INJECTION 500IU/VIAL BAXTER HEALTHCARE<br />

LIMITED<br />

POWDER FOR INJECTION 1000 IU BAXTER HEALTHCARE<br />

LTD<br />

POWDER FOR INJECTION 250IU/BOTTLE BAXTER HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

HEPA-MERZ GRANULES 3 G MERZ+CO. GMBH & CO. GERMANY<br />

HEPA-MERZ INFUSION<br />

CONCENTRATE<br />

5.0 G MERZ+CO. GMBH & CO. GERMANY<br />

HEPAPLUS 30 EMGEL GEL 30000IU/100G HEXAL AG GERMANY<br />

HEPARIN SOLUTION FOR<br />

INJECTION<br />

HEPARIN ‘LEO’ SOLUTION FOR<br />

INJECTION<br />

100IU/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

5,000IU/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

UNITED KINGDOM<br />

DENMARK


EN<br />

582 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

HEPARIN CALCIUM INJECTION<br />

5000 IU/0.5ML<br />

HEPARIN INJECTION BP<br />

5,000UNITS/ML<br />

INECTION SOLUTION 5000 IU/0.5ML B.BRAUN MELSUNGEN<br />

AG<br />

SOLUTION FOR<br />

INJECTION<br />

HEPARIN SODIUM 100IU/ML AMPOULE SOLN F/<br />

INFUSION<br />

HEPARIN SODIUM 2000U/L IN<br />

0.9% SOD. CHL.<br />

HEPARIN SODIUM BP 1000IU/L IN<br />

0.9% NACL<br />

HEPARIN SODIUM BP 1000U/L IN<br />

0.9% NACL<br />

HEPARIN SODIUM INJECTION<br />

5000 IU/ML<br />

HEPARIN SODIUM INJECTION<br />

5000IU/0.2ML<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

HEPARIN SODIUM INJECTION USP SOLUTION FOR<br />

INJECTION<br />

HEPARIN SODIUM IV FLUSH<br />

SOLN.<br />

HEPARINISED SALINE, 50IU IN<br />

5ML<br />

5000UNITS/ML ROTEXMEDICA GMBH,<br />

ARZNEIMITTELWERK<br />

GERMANY<br />

GERMANY<br />

1000IU/ML LEO LABORATORIES LTD UNITED KINGDOM<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

SOL. FOR INJ NA BAXTER HEALTHCARE<br />

LTD<br />

INJECTION SOLUTION 5000 IU/ML B.BRAUN MELSUNGEN<br />

AG<br />

INJECTION SOLUTION 5000IU/0.2ML B.BRAUN MELSUNGEN<br />

AG<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

HEPARINOL-5000 (5MI) SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

5000 USP U/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

10IU/ML LEO LABORATORIES LTD UNITED KINGDOM<br />

10IU/ML CP PHARMACEUTICALS<br />

LTD<br />

5000IU/ML AIN MEDICARE SDN.<br />

BHD.<br />

UNITED KINGDOM<br />

MALAYSIA<br />

HEPATECT SOL. FOR IV INJ. N/A BIOTEST PHARMA GMBH GERMANY<br />

HEPAVAX-GENE POWDER FOR INJ 20UG GREEN CROSS VACCINE<br />

CORP.<br />

HEPAVAX-GENE 20MCG LIQUID FOR INJECTION N/A KOREA GREEN CROSS<br />

CORP.,<br />

HEP-FLUSH SOLUTION N/A LEO LABORATORIES<br />

LIMITED<br />

HEP-FLUSH INJECTION SOLUTION FOR<br />

INJECTION<br />

HEPLOK FORMERLY HEPARIN<br />

MUCOUS INJECTION<br />

SOLUTION FOR<br />

INJECTIONS<br />

HEPSAL SOLUTION FOR<br />

INJECTION<br />

HEPSAL INJECTION 10IU/ML SOLUTION FOR<br />

INJECTION<br />

HEPSAL INJECTION 10IU/ML SOLUTION FOR<br />

INJECTION<br />

100IU/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

10 UNITS/ML LEO LABORATORIES<br />

LIMITED<br />

50IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

10IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

10IU/ML CP PHARMACEUTICALS<br />

LTD<br />

HERBALUX COATED TABLET N/A PETER BLACK<br />

HEALTHCARE LTD. T/A<br />

ENGLISH GRAINS<br />

HEALTHCARE<br />

HERBALUX/GERARD HOUSE<br />

HERBALUX<br />

COATED TABLET N/A PETER BLACK<br />

HEALTHCARE LIMITED<br />

HERECEPTIN POWDER FOR INFUSION 150MG ROCHE REGISTRATION<br />

LTD. — UK (EMEA)<br />

KOREA (DEM PEOPLE'S<br />

REP)<br />

KOREA REPUBLIC<br />

UNITED KINGDOM<br />

DENMARK<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 583<br />

Trade Name Dosage Form Dose MA Holder Country<br />

HERPILEM POWDER FOR INJECTION 250MG LEMERY, S.A. DE C.V. MEXICO<br />

HERRON BABY TEETHING GEL TUBE 87MG/G HERRON<br />

PHARMACEUTICALS PTY<br />

LTD<br />

HEXEDIN, GENERICON TABLET N/A GENERICON PHARMA<br />

GES.M.B.H<br />

AUSTRALIA<br />

GERMANY<br />

HEXIGEL DENTAL GEL 0.5% W/W PARKE DAVIS FRANCE<br />

HHT 4 I.U. FREEZE DRIED PWR FOR<br />

INJ<br />

4 IU INSTITUTO SIDUS S.A. ARGENTINA<br />

HIBERIX POWDER FOR INJECTION NA GLAXOSMITHKLINE<br />

BIOLOGICALS<br />

HIBERIX (HAEMOPHILUS<br />

INFLUENZAE TYPE B)<br />

HIBICET HOSPITAL<br />

CONCENTRATE<br />

HIBICET HOSPITAL<br />

CONCENTRATE<br />

FREEZE-DRIED VACCINE 10MCG SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

BELGIUM<br />

BELGIUM<br />

TOPICAL SOLUTION N/A ZENECA LIMITED UNITED KINGDOM<br />

TOPICAL SOLUTION NA TUBIFOAM LIMITED UNITED KINGDOM<br />

HIBISCRUB TOPICAL SOLUTION 4% W/V ZENECA LIMITED UNITED KINGDOM<br />

HIBISCRUB TOPICAL SOLUTION 4%W/V TUBIFOAM LIMITED UNITED KINGDOM<br />

HIBISOL SOLUTION 0.5% W/V ZENECA LIMITED UNITED KINGDOM<br />

HIBISOL SOLUTION TOPICAL SOLUTION 2.5% V/V ZENECA LIMITED UNITED KINGDOM<br />

HIBISOL SOLUTION TOPICAL SOLUTION 2.5%V/V TUBIFOAM LIMITED UNITED KINGDOM<br />

HIBITANE OBSTETRIC CREAM 1% W/W ZENECA LIMITED UNITED KINGDOM<br />

HIBITANE 5% CONCENTRATE TOPICAL SOLUTION 5%W/V TUBIFOAM LIMITED UNITED KINGDOM<br />

HIBITANE CONCENTRATE<br />

SOLUTION 5%<br />

TOPICAL SOLUTION 25% V/V ZENECA LIMITED UNITED KINGDOM<br />

HIBITANE OBSTETRIC CREAM CREAM 5% V/ W BIOGLAN<br />

LABORATORIES LTD<br />

HIBTITER SOLUTION FOR<br />

INJECTION<br />

HIBTITER SOLUTION FOR<br />

INJECTION<br />

HIBTITER SOLUTION FOR<br />

INJECTION<br />

HIBTITER HAEMOPHILUS B<br />

CONJUGATE VACCINE<br />

SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

N/A WYETH PHARMA GMBH GERMANY<br />

NA CYANAMID OF GREAT<br />

BRITAIN LTD<br />

NA WYETH LEDERLE SPA ITALY<br />

N/A CYANAMID OF GREAT<br />

BRITAIN LTD.<br />

HIDRASEC CAPSULE 100MG LABORATOIRES<br />

BIOPROJET PHARMA<br />

HIDRASEC 18MG PAEDIATRIC ORAL POWDER 18MG LABORATOIRE<br />

BIOPROJET PHARMA<br />

HIDRASEC 30MG PAEDIATRIC ORAL POWDER 30MG LABORATOIRE<br />

BIOPROJET PHARMA<br />

HIDRASEC 6MG PAEDIATRIC ORAL POWDER 6MG LABORATOIRE<br />

BIOPROJET PHARMA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE


EN<br />

584 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

HIKMA-HEPARIN 25000 VIALS SOLUTION FOR<br />

INJECTION<br />

HILL'S BALSAM CHESTY COUGH<br />

LIQ F/CHILD.<br />

HILL'S BALSAM CHESTY COUGH<br />

LIQUID<br />

25000IU/ML HIKMA<br />

PHARMACEUTICALS<br />

ORAL LIQUID N/A EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

ORAL LIQUID 100MG/5ML EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

HIRIDOID GEL GEL 0.3%W / W SANKYO PHARMA UK<br />

LIMITED<br />

JORDAN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

HIRUDOID CREAM 300MG/100G SANKYO PHARMA GMBH GERMANY<br />

HIRUDOID GEL 300MG/100G SANKYO PHARMA GMBH GERMANY<br />

HIRUDOID CREAM CREAM 0.3% W/W SANKYO PHARMA UK<br />

LIMITED<br />

HISTALIX SYRUP N/A WALLACE<br />

MANUFACTURING<br />

CHEMISTS LIMITED<br />

HISTASIN TABLET 10MG DELTA HF ICELAND<br />

HISTERGAN CREAM CREAM 2%W/W NORMA CHEMICALS<br />

LIMITED<br />

HIVOTEX SYRUP 30MG/5ML KLEVA LIMITED GREECE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

HOLOXAN POWDER FOR INJECTION 500MG ASTA MEDICA GERMANY<br />

HOLOXAN POWDER FOR INJECTION 1G ASTA MEDICA GERMANY<br />

HOLOXAN POWDER FOR INJECTION 2G ASTA MEDICA GERMANY<br />

HONEY AND LEMON MELTUS<br />

FOR DEEP CHESTY COU<br />

ORAL SOLUTION 50 MG CUPAL LIMITED UNITED KINGDOM<br />

HONEY AND MOLASSES MIXTURE ORAL SOLUTION N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

UNITED KINGDOM<br />

HONVAN TABLETS 120MG ASTA MEDICA GERMANY<br />

HONVAN SOLUTION FOR<br />

INJECTION<br />

300MG/5ML ASTA MEDICA GERMANY<br />

HORESTYL TABLETS 10MG KLEVA LTD GREECE<br />

HORESTYL SYRUP 5MG/5ML KLEVA LTD. GREECE<br />

HORESTYL TABLETS 10MG KLEVA LIMITED GREECE<br />

HORESTYL SYRUP 5MG/5ML KLEVA LIMITED GREECE<br />

HOT LEMON COLD RELIEF<br />

POWDER<br />

POWDER FOR ORAL<br />

SOLUTION<br />

N/A SUSSEX<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

HRI NIGHT TABLETS COATED TABLETS NA JESSUP HEALTH LIMITED UNITED KINGDOM<br />

HRI WATER BALANCE TABLETS COATED TABLETS NA JESSUP HEALTH LIMITED UNITED KINGDOM<br />

HUMALOG CARTRIDGE SOLUTION FOR<br />

INJECTION<br />

HUMALOG CARTRIDGE SOLUTION FOR<br />

INJECTION<br />

100UNITS/ML ELI LILLY NEDERLAND<br />

B.V.<br />

100UNITS/ML ELI LILLY NEDERLAND<br />

B.V.<br />

NETHERLANDS<br />

NETHERLANDS


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 585<br />

Trade Name Dosage Form Dose MA Holder Country<br />

HUMALOG VIALS SOLUTION FOR<br />

INJECTION<br />

HUMAN ALBUMIN<br />

‘OCTAPHARMA’ 20%<br />

SOLUTION FOR<br />

INFUSION<br />

100 UNITS/ML ELI LILLY NEDERLAND<br />

B.V.<br />

182.4-210MG/ML OCTAPHARMA<br />

PHARMAZEUTIKA<br />

PRODUKTIONSGES.M.B.H.<br />

NETHERLANDS<br />

AUSTRIA<br />

HUMAN ALBUMIN 20% BIOTEST SOL. FOR I.V. USE 200G/1000ML BIOTEST PHARMA GMBH GERMANY<br />

HUMAN ALBUMIN 20% IMMUNO<br />

SOL FOR INJ<br />

SOLUTION FOR<br />

INJECTION<br />

HUMAN ALBUMIN 5% BIOTEST SOL. FOR INTRAVENOUS<br />

USE<br />

HUMAN ALBUMIN 5% BIOTEST<br />

ISOTONIC<br />

HUMAN ALBUMIN 5% IMMUNO<br />

SOL FOR INJ<br />

HUMAN ANTI-D (RHO)<br />

IMMUNOGLOBULIN 15%SOL<br />

HUMAN HEP B<br />

IMMUNOGLOBULIN PROTEIN SOL<br />

HUMAN HEP B<br />

IMMUNOGLOBULIN PROTEIN SOL<br />

HUMAN IMMUNOGLOBULIN<br />

‘OCTAPHARMA’ 5%<br />

HUMAN RABIES<br />

IMMUNOGLOBULIN FOR IM INJ<br />

HUMAN TETANUS IMMUNOGLO.<br />

PROTEIN SOLUT.<br />

N/A BAXTER AG AUSTRIA<br />

50G/1000ML BIOTEST PHARMA GMBH GERMANY<br />

ISOT.SOL.FOR IV USE 50G/1000ML BIOTEST PHARMA GMBH GERMANY<br />

SOLUTION FOR<br />

INJESTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INFUSION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

N/A BAXTER AG AUSTRIA<br />

500IU/VIAL BIOPRODUCTS<br />

LABORATORY (BPL)<br />

15% W/V BPL, BIO PRODUCTS<br />

LABORATORY<br />

15% W/V BPL, BIO PRODUCTS<br />

LABORATORY<br />

45.6-52.5MG/ML OCTAPHARMA<br />

PHARMAZEUTIKA<br />

PRODUKTIONSGES.M.B.H<br />

15% W/V BPL, BIO PRODUCTS<br />

LABORATORY<br />

15%V/W BIOPRODUCTS<br />

LABORATORY (BPL)<br />

HUMATROPE POWDER FOR INJECTION 4IU(1.33MG)/2ML LABORATOIRES LILLY<br />

FRANCE<br />

HUMATROPE POWDER FOR INJECTION 18IU(6MG)/3ML LABORATOIRES LILLY<br />

FRANCE<br />

HUMATROPE POWDER FOR INJECTION 16IU(5.3MG)/8ML LABORATOIRES LILLY<br />

FRANCE<br />

HUMATROPE POWDER FOR INJECTION 36IU(12MG)/3ML LABORATOIRES LILLY<br />

FRANCE<br />

HUMATROPE POWDER FOR INJECTION 72IU(24MG)/3ML LABORATOIRES LILLY<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AUSTRIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

HUMEX FOURNIER INHALER N/A URGO SA FRANCE<br />

HUMULIN 70/30 SUSPEN. FOR SC/IM<br />

INJECT.<br />

HUMULIN 70/30 (30% RAPID<br />

ACTING 70% NPH)<br />

HUMULIN L (HUMULIN INSULIN<br />

LONG ACTING)<br />

HUMULIN N (HUMAN INSULIN<br />

NPH)<br />

SUSPENSION FOR<br />

INJECTION<br />

SUSPENSION FOR<br />

INJECTION<br />

SUSPENSION FOR<br />

INJECTION<br />

HUMULIN NPH SUSPEN. FOR SC/IM<br />

INJEC.<br />

300IU/3ML LILLY FRANCE S.A. FRANCE<br />

100IU/ML LILLY DEUTSCHLAND<br />

GMBH<br />

100IU/ML LILLY DEUTSCHLAND<br />

GMBH<br />

100IU/ML LILLY DEUTSCHLAND<br />

GMBH<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

300IU/3ML LILLY FRANCE S.A. FRANCE


EN<br />

586 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

HUMULIN R SOLUTION FOR SC/IM<br />

INJEC.<br />

HUMULIN R (HUMAN INSULIN<br />

RAPID ACTING)<br />

HUMULIN U (HUMAN INSULIN<br />

ULTRA LONG ACT)<br />

300IU/3ML LILLY FRANCE S.A. FRANCE<br />

LIQUID FOR INJECTION 100IU/ML LILLY DEUTSCHLAND<br />

GMBH<br />

SUSPENSION FOR<br />

INJECTION<br />

100IU/ML LILLY DEUTSCHLAND<br />

GMBH<br />

HYALASE DRIED POWDER FOR INJ. 1500IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

HYALASE (HYALURONIDASE FOR<br />

INJECTION BP)<br />

HYALGAN SOLUTION FOR<br />

INJECTION<br />

HYALGAN SOLUTION FOR<br />

INJECTION<br />

POWDER FOR INJECTION 1500IU/AMPOULE CP PHARMACEUTICALS<br />

LTD<br />

GERMANY<br />

GERMANY<br />

20MG/ML FIDIA SPA ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

10MG/ML FIDIA SPA ITALY UNITED KINGDOM<br />

HYCAMTIN FOR INJECTION POWDER FOR INJECTION 4MG SMITHKLINE BEECHAM<br />

PHARMACEUTICALS<br />

HYCROCORTISONE TABLET 10MG REKAH<br />

PHARMACEUTICAL<br />

INDUSTRY LTD<br />

HYDERGIN ORAL DROPS (SOL.) 1MG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

HYDERM CREAM 1% W/W CREAM 1% W/W TARO<br />

PHARMACEUTICALS INC.<br />

HYDRACORT CREAM 0.5% W/W LABORATOIRES<br />

GALDERMA<br />

UNITED STATES OF<br />

AMERICA<br />

ISRAEL<br />

SWITZERLAND<br />

CANADA<br />

FRANCE<br />

HYDRALAZINE TABLETS 25MG REMEDICA LTD. CYPRUS<br />

HYDRALAZINE TABLET 25MG GENERICS (UK) LIMITED<br />

—UK<br />

HYDREA CAPSULES 500MG BRISTOL MYERS SQUIBB ITALY<br />

HYDREX SURGICAL<br />

SCRUB-CHLORHEXIDINE<br />

TOPICAL SOLUTION 4% W/V ADAMS HEALTHCARE<br />

LIMITED<br />

HYDROCORTISONE CREAM 1% HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

HYDROCORTISONE CREAM 1%W/W CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

HYDROCORTISONE 1% OINTMENT 1% W/W BIOREX LABORATORIES<br />

LTD.<br />

HYDROCORTISONE 1% B.P. CREAM 1% W/W BIOREX LABORATORIES<br />

LTD.<br />

HYDROCORTISONE CREAM CREAM 1% W/V NORTON<br />

PHARMACEUTICALS<br />

LIMITED<br />

HYDROCORTISONE CREAM 1%<br />

OTC<br />

HYDROCORTISONE CREAM 1%<br />

W/W<br />

HYDROCORTISONE CREAM B.P<br />

1%<br />

CREAM 1% W/V NORTON<br />

PHARMACEUTICALS<br />

LIMITED<br />

CREAM 1% W/W CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

CREAM 1% W / W BIOREX LABORATORIES<br />

LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

MALAYSIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 587<br />

HYDROCORTISONE EYE<br />

OINTMENT BPC 1%<br />

Trade Name Dosage Form Dose MA Holder Country<br />

EYE OINTMENT 1%W/W MARTINDALE<br />

PHARMACEUTICALS LTD<br />

HYDROCORTISONE/HYDRODERM OINTMENT 10MG/G SCHERING-PLOUGH S.A. BELGIUM<br />

HYDROCORTISONE-MEDO<br />

100MG<br />

POWDER FOR INJECTION 100MG MEDOCHEMIE LTD CYPRUS<br />

HYDROCORTISYL SKIN CREAM CREAM 1% W/W ROUSSEL<br />

LABORATORIES LIMITED<br />

HYDROCORTISYL SKIN<br />

OINTMENT<br />

OINTMENT 1% W/W ROUSSEL<br />

LABORATORIES LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

HYDROGEN PEROXIDE TOPICAL SOLUTION 6%V/V LCM LTD UNITED KINGDOM<br />

HYDROGEN PEROXIDE SOLUTION SOLUTION 6%BP 20 VOLS LCM LIMITED UNITED KINGDOM<br />

HYDROGEN PEROXIDE SOLUTION TOPICAL SOLUTION 9% 30 VOLS LCM LTD UNITED KINGDOM<br />

HYDROGEN PEROXIDE SOLUTION<br />

9% 30 VOLS<br />

TOPICAL SOLUTION 9%V/V LCM LTD UNITED KINGDOM<br />

HYDROMOL CREAM CREAM N/A QUINODERM LIMITED UNITED KINGDOM<br />

HYDROXOCOBALAMIN INJECTION BP 1MG ROTEXMEDICA GMBH,<br />

ARZNEIMITTELWERK -<br />

GERMANY<br />

HYDROXOCOBALAMIN<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

GERMANY<br />

1MG/1ML GOLDSHIELD GROUP PLC UNITED KINGDOM<br />

HYGROTON TABLETS 50MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

HYOSCINE BUTYLBROMIDE FILM-COATED TABLETS 10MG PHARMAMED LTD. MALTA<br />

HYOSCINE BUTYLBROMIDE FILM-COATED TABLETS 20MG PHARMAMED LTD. MALTA<br />

HYOSCINE BUTYLBROMIDE<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

HYOSCINE INJECTION BP SOLUTION FOR<br />

INJECTION<br />

SWITZERLAND<br />

20MG/1ML ROTEXMEDICA GMBH GERMANY<br />

400MCG/1ML EVANS MEDICAL LIMITED UNITED KINGDOM<br />

HYPERIUM 1MG TABLET 1MG LES LABORATOIRES<br />

SERVIER<br />

FRANCE<br />

HYPNOMIDATE 10ML AMPOULE 2MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

HYPOVASE TABLET N/A PFIZER LIMITED UNITED KINGDOM<br />

HYPOVASE TABLET 500MCG PFIZER LIMITED UNITED KINGDOM<br />

HYPOVASE TABLETS 1MG PFIZER LIMITED UNITED KINGDOM<br />

HYPOVASE TABLET 5MG PFIZER LIMITED UNITED KINGDOM<br />

HYPOVASE TABLET 2MG PFIZER LIMITED UNITED KINGDOM<br />

HYPRIN BOVINE ISOPHANE SUSPENSION FOR<br />

INJECTION<br />

HYPROMELLOSE EYE DROPS BPC<br />

0.3%<br />

HYPURIN BOVINE LENTE SUSPENSION FOR<br />

INJECTION<br />

HYPURIN BOVINE NEUTRAL SOLUTION FOR<br />

INJECTION<br />

100IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

EYE DROPS 0.3%W/V MARTINDALE<br />

PHARMACEUTICALS LTD<br />

100IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

100IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

588 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

HYPURIN BOVINE PROTAMINE<br />

ZINC<br />

SUSPENSION FOR<br />

INJECTION<br />

HYPURIN PORCIN NEUTRAL SOLUTION FOR<br />

INJECTION<br />

HYPURIN PORCINE BIPHASIC<br />

ISOPHANE<br />

SUSPENSION FOR<br />

INJECTION<br />

HYPURIN PORCINE ISOPHANE SUSPENSION FOR<br />

INJECTION<br />

100IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

100IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

N/A CP PHARMACEUTICALS<br />

LTD.<br />

100IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

HYTRIN 1MG TABLETS 1MG ABBOTT LABORATORIES<br />

LIMITED<br />

HYTRIN 2MG TABLETS 2MG ABBOTT LABORATORIES<br />

LIMITED<br />

HYTRIN 5MG TABLETS 5MG ABBOTT LABORATORIES<br />

LIMITED<br />

HYTRIN BPH 10MG TABLETS 10MG ABBOTT LABORATORIES<br />

LTD.<br />

HYTRIN BPH 1MG STARTER KIT TABLETS 1MG ABBOTT LABORATORIES<br />

LTD.<br />

HYTRIN BPH 2MG TABLETS 2MG ABBOTT LABORATORIES<br />

LTD<br />

HYTRIN BPH 5MG TABLETS 5MG ABBOTT LABORATORIES<br />

LTD.<br />

HYZAAR 50/12.5MG TABLET N/A MERCK SHARP & DOHME<br />

B.V.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

IBUFEN TABLET 200 MG DELTA HF ICELAND<br />

IBUFEN TABLET 400MG DELTA HF ICELAND<br />

IBUFEN TABLET 600MG DELTA HF ICELAND<br />

IBUGESIC 200 FILM COATED TABLETS 200MG DAR AL DAWA DEV. &<br />

INV. CO. LTD.<br />

IBUGESIC-200 TABLET 200MG CIPLA LIMITED INDIA<br />

JORDAN<br />

IBUHEXAL 200 FILM COATED TABLET 200MG HEXAL AG GERMANY<br />

IBUKOD TABLETS N/A DELTA HF ICELAND<br />

IBUKOD STERKAR TABLETS TABLET N/A DELTA HF ICELAND<br />

IBULEVE/IBULEVE SPORT<br />

GEL5%W/W / IBUDERM<br />

GEL 5% W/W DIOMED DEVELOPMENTS<br />

LIMITED T/A DERMAL<br />

LABORATORIES<br />

IBUPROFEN TABLETS 200MG NORTON HEALTHCARE<br />

LIMITED<br />

IBUPROFEN TABLETS 400MG NORTON HEALTHCARE<br />

LIMITED<br />

IBUPROFEN COATED TABLETS 200MG PHARMAMED LTD. MALTA<br />

IBUPROFEN TABLETS 400MG PHARMAMED LTD. MALTA<br />

IBUPROFEN 200MG COATED TABLETS 200MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 589<br />

Trade Name Dosage Form Dose MA Holder Country<br />

IBUPROFEN 400MG COATED TABLET 400MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

IBUPROFEN 5% GEL GEL 5% W/W GOLDSHIELD<br />

PHARMACEUTICALS LTD<br />

IBUPROFEN BP 200MG TABLET 200MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

IBUPROFEN BP 400MG TABLET 400MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

IBUPROFEN BP 600MG TABLET 600MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IBUPROFEN DENK 400 FILM COATED TABLET 400MG E.DENK OHG GERMANY<br />

IBUPROFEN TABLETS COATED TABLETS 200MG HEALTHY IDEAS LIMITED UNITED KINGDOM<br />

IBUPROFEN TABLETS BP 200 MG TABLET 200 MG CIPLA LTD INDIA<br />

IBUSPAN TABLETS 200MG SM PHARMACEUTICALS<br />

SDN. BHD.<br />

IBUTOP CUPROFEN IBUPROFEN<br />

GEL<br />

GEL 5% W/W SETON PRODUCTS<br />

LIMITED<br />

IBUTOP GEL GEL 5G/100G DOLORGIET GMBH & CO.<br />

KG<br />

ICTHTAMMOL OINTMENT BP<br />

1980<br />

MALAYSIA<br />

UNITED KINGDOM<br />

GERMANY<br />

OINTMENT 10%W/W THORNTON & ROSS LTD UNITED KINGDOM<br />

IDEOS CHEWABLE TABLET N/A LABORATOIRE<br />

INNOTHERA<br />

IDRACEMI OPHTHALMIC DROPS 0.335G FARMIGEA SPA ITALY<br />

IDRACEMI OPHTHALMIC OINTMENT N/A 014438 030 ITALY<br />

IDUCHER OPHTHALMIC DROPS 0.2G FARMIGEA SPA ITALY<br />

IDUCHER OPHTHALMIC OINTMENT 0.2G/100G FARMIGEA SPA ITALY<br />

IETAPAR CAPSULE N/A ROTTAPHARM S.R.L ITALY<br />

IETEPAR INJECTABLE IM SOLN. N/A ROTTAPHARM SRL ITALY<br />

IFICIPRO SOL. FOR INJECTION 200MG IFIUNIK<br />

PHARMACEUTICALS<br />

LIMITED<br />

IFICIPRO — CIPROFLOXACIN<br />

INJECTION 200MG<br />

SOLUTION FOR<br />

INJECTION<br />

200MG (2MG/ML) UNIQUE<br />

PHARMACEUTICAL<br />

LABORATORIES<br />

FRANCE<br />

IKOREL TABLETS 10MG MAY & BAKER LIMITED UNITED KINGDOM<br />

ILOMEDIN SOLUTION FOR IV<br />

INFUSION<br />

INDIA<br />

INDIA<br />

0.05MG/0.5ML SCHERING AG GERMANY<br />

ILOSONE 125MG/5ML SUSPENSION 125MG/5ML DISTA S.A. SPAIN<br />

ILOSONE 500MG COATED TABLET 500MG LILLY, S.A. SPAIN<br />

IMDUR PROLONGED RELEASE<br />

TABLETS<br />

60MG HASSLE LAKEMEDEL AB SWEDEN


EN<br />

590 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

IMIGRAN COATED TABLETS 50MG GLAXO WELLCOME UK<br />

LIMITED<br />

IMIGRAN 100MG FILM COATED TABLETS 100MG GLAXO WELLCOME UK<br />

LIMITED<br />

IMIGRAN INJECTION SOLUTION FOR<br />

INJECTION<br />

12MG/ML GLAXO WELLCOME UK<br />

LIMITED<br />

IMIGRAN TABLETS 100MG FILM COATED TABLET 100MG GLAXO WELLCOME UK<br />

LTD<br />

IMIGRAN TABLETS 50MG TABLET 50MG GLAXO WELLCOME UK<br />

LTD<br />

IMIPRAMINE BP 10MG TABLET 10MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

IMIPRAMINE BP 25MG TABLET 25MG SUSSEX<br />

PHARMACEUITICAL<br />

LIMITED<br />

IMMUBRON TABLET 50MG BRUSCHETTINI SRL ITALY<br />

IMMUCYST — PWS-LIQ ITV PRC<br />

LIQUID<br />

IMMUCYST -PWS LIQ ITV PRC<br />

LIQUID<br />

POWDER FOR SOLUTION 27MG/ML CONNAUGHT<br />

LABORATORIES LIMITED<br />

POWDER FOR SOLUTION 81MG/3ML CONNAUGHT<br />

LABORATORIES LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CANADA<br />

CANADA<br />

IMMULEM SOLUTION 5G/50ML LEMERY S.A MEXICO<br />

IMMUNATE 1000 I.E POWDER FOR INJECTION N/A BAXTER AG AUSTRIA<br />

IMMUNATE 250 I.E POWDER FOR INJECTION N/A BAXTER AG AUSTRIA<br />

IMMUNATE 500 I.E POWDER FOR INJECTION N/A BAXTER AG AUSTRIA<br />

IMMUNOGLOBULINE I.V. (NRM.<br />

I.V. IMMUNOG)<br />

PWD. FOR SOL. FOR. INF. N/A CLB NETHERLANDS<br />

IMMUNOVIR CREAM 5%W/W FARMA UNO SRL ITALY<br />

IMOCAP CAPSULE 2MG RAZA MANUFACTURING<br />

BERHAD<br />

MALAYSIA<br />

IMODIUM CAPSULE 2MG JANSSEN-CILAG N.V. BELGIUM<br />

IMODIUM CAPSULE 2MG JANSSEN PAKISTAN<br />

IMODIUM CAPSULE 2MG JANSSEN PAKISTAN<br />

IMOGRAM RAGE 150UI/ML INJECTABLE SOLUTION 150IU/1ML PASTEUR MERIEX<br />

SERUMS ET VACCINS<br />

IMOVAX POLIO INJECTABLE SOLUTION N/A PASTEUR MERIEUX<br />

CONNAUGHT<br />

IMOX(AMOXICILLIN CAPSULES BP) CAPSULE 250MG IPCA LABORATORIES<br />

LIMITED<br />

IMPLANON IMPLANT (SUB-DERMAL<br />

USE)<br />

IMPORTAL ORAL POWDER IN<br />

SACHETS<br />

68MG ORGANON<br />

LABORATORIES LIMITED<br />

10G NOVARTIS CONSUMER<br />

HEALTH SA<br />

FRANCE<br />

FRANCE<br />

INDIA<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

IMUPRIN TABLETS 50MG REMEDICA LTD. CYPRUS


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 591<br />

Trade Name Dosage Form Dose MA Holder Country<br />

IMURAN TABLETS 50MG THE WELLCOME<br />

FOUNDATION LTD.<br />

IMURAN FILM COATED TABLETS 25MG THE WELLCOME<br />

FOUNDATION LTD.<br />

IMURAN COATED TABLETS 50MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

IMURAN FILM-COATED TABLETS 25MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

INAPROL TABLETS 250MG BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

TURKEY<br />

INCIDAL TABLET N/A BAYER PAKISTAN<br />

INDERAL COATED TABLET 10MG ZENECA LIMITED UNITED KINGDOM<br />

INDERAL COATED TABLET 40MG ZENECA LIMITED UNITED KINGDOM<br />

INDERAL INJECTION SOLUTION FOR<br />

INJECTION<br />

INDERAL LA MODIFIED RELEASE<br />

CAPSULES<br />

0.1% W/V ZENECA LIMITED UNITED KINGDOM<br />

160MG ZENECA LIMITED UNITED KINGDOM<br />

INDERAL LA-80 CAPSULE 80MG ZENECA LIMITED UNITED KINGDOM<br />

INDOCEM 25 CAPSULES 25MG AEGIS LTD. CYPRUS<br />

INDOCID 100MG SUPPOSITORY 100MG MERCK SHARP & DOHME<br />

B.V.<br />

INDOCID 25MG CAPSULE 25MG MERCK SHARP & DOHME<br />

B.V.<br />

INDOCID RETARD 75MG CAPSULE 75MG MERCK SHARP & DOHME<br />

B.V.<br />

INDOGESIC SUPPOSITORIES 100MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

INDOGESIC 25 CAPSULE 25MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD<br />

INDOLGINA CAPSULE 25MG J.URIACH & CIA. S.A. SPAIN<br />

INDOLGINA SUPPOSITORY 100MG J.URIACH & CIA. S.A. SPAIN<br />

INDOMELAN CAPSULE 25MG LANNACHER HEILMITTEL<br />

GMBH.<br />

INDOMELAN SUPPOSITORY 100MG LANNACHER HEILMITTEL<br />

GMBH.<br />

INDOMETHACIN SUPPOSITORIES 100MG NORTON HEALTHCARE<br />

LIMITED<br />

INDOMETHACIN BP 25MG CAPSULE 25MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

INDOMETHACIN BP 50MG CAPSULE 50MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

INDOMETHACIN CAPSULES BP CAPSULE 25MG IPCA LABORATORIES<br />

LIMITED<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

JORDAN<br />

JORDAN<br />

AUSTRIA<br />

AUSTRIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

INDIA


EN<br />

592 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

INDOPREX EYE DROPS SOLUTION 2% DEMO S.A GREECE<br />

INDOREM 25 TABLETS 25MG REMEDICA LTD CYPRUS<br />

INDYLON 100MG SUPPOSITORIES 100MG MEDOCHEMIE LTD CYPRUS<br />

INDYLON 25MG CAPSULE 25MG MEDOCHEMIE LTD CYPRUS<br />

INFACOL ORAL LIQUID 4% W/V PHARMAX LIMITED UNITED KINGDOM<br />

INFANRIX SUSPENSION FOR<br />

INJECTION<br />

INFANRIX HEPB SUSPENSION FOR<br />

INJECTION<br />

N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS S.A.<br />

INFANRIX HEXA SEE REMARKS NA SMITHKLINE BEECHAM<br />

BIOLOGICALS S.A.<br />

INFANRIX IPV (DTPA-IPV) SUSPENSION FOR<br />

INJECTION<br />

INFANRIX IPV+HIB SUSPENSION FOR<br />

INJECTION<br />

INFANRIX-HIB SUSPENSION FOR<br />

INJECTION<br />

SEE REMARKS GLAXOSMITHKLINE<br />

BIOLOGICALS S.A.<br />

N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

BELGIUM<br />

BELGIUM<br />

EUROPEAN COMMUNITY<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

INFECTOFLAM EYE OINTMENT N/A CIBA VISION AG SWITZERLAND<br />

INFECTOFLAM EYE DROPS N/A CIBA VISION AG SWITZERLAND<br />

INFECTOFLAM EYE OINTMENT NA NOVARTIS<br />

OPHTHALMICS AG<br />

INFECTOFLAM EYE DROPS NA NOVARTIS OPHTHAMICS<br />

AG<br />

INFED (IRON DEXTRAN<br />

INJECTION USP)<br />

INFLEXAL BERNA V SUSPENSION FOR<br />

INJECTION<br />

SOLN F/IM IV USE 50MG/ML SCHEIN<br />

PHARMACEUTICAL INC.<br />

N/A ISTITUTO<br />

SIEROTERAPICO BERNA<br />

S.R.L.<br />

INFLORAN BERNA CAPSULES N/A SWISS SERUM AND<br />

VACCINE INSTITUTE<br />

BERNE<br />

INFLUVAC 2000/2001 SUSPENSION FOR<br />

INJECTION<br />

INFLUVAC 2001/2002 SUSPENSION FOR<br />

INJECTION<br />

INFLUVAC 2002/2003 SUSPENSION FOR<br />

INJECTION<br />

15MCG/0.5ML SOLVAY<br />

PHARMACEUTICALS B.V.<br />

15 MCG/0.5 SOLVAY<br />

PHARMACEUTICALS B.V.<br />

15MCG/ML SOLVAY<br />

PHARMACEUTICALS B.V.<br />

INHALANT CAPSULES INHALATION LIQUID N/A INDUSTRIAL<br />

PHARMACEUTICAL<br />

SERVICE LIMITED<br />

INNOHEP SOLUTION FOR<br />

INJECTION<br />

INNOHEP SOLUTION FOR<br />

INJECTION<br />

INNOHEP SOLUTION FOR<br />

INJECTION<br />

3500IU/0.35ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

4500IU/0.45ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

10,000IU/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

SWITZERLAND<br />

SWITZERLAND<br />

UNITED STATES OF<br />

AMERICA<br />

ITALY<br />

SWITZERLAND<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

UNITED KINGDOM<br />

DENMARK<br />

DENMARK<br />

DENMARK


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 593<br />

Trade Name Dosage Form Dose MA Holder Country<br />

INNOHEP SOLUTION FOR<br />

INJECTION<br />

INNOHEP SOLUTION FOR<br />

INJECTION<br />

INNOHEP SOLUTION FOR<br />

INJECTION<br />

INNOHEP 10,000IU/ML SOLUTION FOR<br />

INJECTION<br />

INNOHEP 20,000IU/ML SOLUTION FOR<br />

INJECTION<br />

INNOHEP SYRINGE 10,000IU/ML SOLUTION FOR<br />

INJECTION<br />

INNOHEP SYRINGE 20,000IU/ML SOLUTION FOR<br />

INJECTION<br />

20,000IU/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

20000IU/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

2,500 IU/0.25ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

DENMARK<br />

DENMARK<br />

DENMARK<br />

10,000IU/ML LEO LABORATORIES LTD DENMARK<br />

20,000IU/ML LEO LABORATORIES LTD UNITED KINGDOM<br />

10,000IU/ML LEO LABORATORIES LTD UNITED KINGDOM<br />

20,000IU/ML LEO LABORATORIES LTD DENMARK<br />

INPANOL TABLETS 10MG TABLET 10MG DRUG HOUSES OF<br />

AUSTRALIA(ASIA) PTE<br />

LTD<br />

SINGAPORE<br />

INSTILLAGEL GEL N/A FARCO-PHARMA GMBH GERMANY<br />

INSULATARD HM PENFILL<br />

100 IU/ML X10ML<br />

INSULATARD HM PENFILL<br />

100 IU/ML.1.5ML<br />

SUSPENSION FOR<br />

INJECTION<br />

SUSPENSION FOR<br />

INJECTION<br />

100IU/ML NOVO NORDISK A/S DENMARK<br />

NA NOVO NORDISK A/S DENMARK<br />

INTAFEN - 200 TABLETS 200MG INTAS-<br />

PHARMACEUTICALS LTD.<br />

INTAL 1MG/DOSE INHALER MET. DOSE PRESS.<br />

AEROSOL<br />

1MG/ACTUATION FISONS LIMITED T/A<br />

RHONE-POULENC RORER<br />

INTAL 1MG/DOSE INHALER AEROSOL 1MG/ACTUATION FISONS LTD T/A RHONE-<br />

POULENC RORER<br />

INTAL INHALER (5MG) MET. DOSE PRESS.<br />

AEROSOL<br />

5MG/ACTUATION FISONS LIMITED T/A<br />

RHONE-POULENC RORER<br />

INTAL INHALER (5MG) AEROSOL 5MG/ACTUATION FISONS LTD T/A RHONE-<br />

POULENC RORER<br />

INTAL NEBULISER SOL. AMPOULE<br />

20MG/2ML<br />

INTAL NEBULISER SOLUTION<br />

AMPOULE<br />

NASAL SPRAY 1% W/V FISONS LIMITED T/A<br />

RHONE-POULENC RORER<br />

NASAL SPRAY 1%W/V FISONS LTD T/A RHONE-<br />

POULENC RORER<br />

INTAL SPINCAPS CAPSULES 20MG INHALATION POWDER 20MG FISONS LIMITED T/A<br />

RHONE-POULENC RORER<br />

INTAL SPINCAPS CAPSULES 20MG 20MG CAPSULE(POWDER) FISONS LTD T/A RHONE-<br />

POULENC RORER<br />

INTALGIN GEL GEL N/A 3M HEALTH CARE<br />

LIMITED<br />

INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

INTERMOXIL DRY SYRUP 125MG/5ML PT INTERBAT INDONESIA<br />

INTERPRIL 10 TABLETS 10MG PT INTERBAT INDONESIA<br />

INTERPRIL 5 TABLET 5MG PT INTERBAT INDONESIA<br />

INTRAFER LIQUID FOR I.M. USE 100MG/2ML GEYMONAT ITALY<br />

INTRAFER ORAL SOLUTION N/A GEYMONAT SPA ITALY


EN<br />

594 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

INTRAFER ORAL DROPS N/A GEYMONAT SPA ITALY<br />

INTRAGLOBIN F SOL FOR INTRAVENOUS<br />

ADM.<br />

INTRALIPID 20% EMULSION FOR<br />

INJECTION<br />

INTRAMED TRICHAZOLE SOLUTION FOR<br />

INFUSION<br />

INTRAVEN GV 101 SOLUTION FOR IV<br />

INFUSION<br />

INTRAVEN GV 102 SOLUTION FOR IV<br />

INFUSION<br />

INTRAVEN GV 112 SOLUTION FOR<br />

INFUSION<br />

INTRAVEN GV 121 SOLUTION FOR IV<br />

INFUSION<br />

INTRAVEN GV 122 SOLUTION FOR IV<br />

INFUSION<br />

INTRAVEN GV 152 SOLUTION FOR IV<br />

INFUSION<br />

INTRAVEN GV 172 SOLUTION FOR IV<br />

INFUSION<br />

INTRAVEN GV 202 SOLUTION FOR IV<br />

INFUSION<br />

INTRAVEN GV 262 SOLUTION FOR IV<br />

INFUSION<br />

INTRAVEN GV 352 SOLUTION FOR IV<br />

INFUSION<br />

INTRAVEN GV104 SOLUTION FOR IV<br />

INFUSION<br />

50MG/ML BIOTEST PHARMA GMBH GERMANY<br />

20%W/V FRESENIUS KABI LIMITED UNITED KINGDOM<br />

500MG/100ML BODENE (PROPIETARY)<br />

LIMITED T/A INTRAMED<br />

— SOUTH AFRICA<br />

0.9% W/V BP GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

0.9% W/V BP GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

0.45% W/V BP GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

5% W/V BP GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

5% W/V BP GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

N/A GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

N/A GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

N/A GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

N/A IVEX PHARMACEUTICALS<br />

LIMITED<br />

N/A GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

0.9% W/VBP GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

SOUTH AFRICA<br />

INTRON A POWDER FOR INJECTION 5×10(6) IU\VIAL SCHERING-PLOUGH LTD. IRELAND<br />

INTRON A POWDER FOR INJECTION 3×10(6)IU/VIAL SCHERING-PLOUGH LTD. IRELAND<br />

INTRON A SOLUTION FOR<br />

INJECTION<br />

INTRON A SOLUTION FOR<br />

INJECTION<br />

INTROPIN SOLUTION FOR<br />

INJECTION<br />

INVANZ POWD. F/CONC F/SOLN<br />

F/INF<br />

18 MILLION IU SP EUROPE IRELAND<br />

25 MILLION IU SP EUROPE IRELAND<br />

40MG/ML FAULDING HOSPITAL<br />

PRODUCTS<br />

1G/VIAL MERCK SHARP & DOHME<br />

LIMITED<br />

INVIRASE CAPSULE 200MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

IODINE SOLUTION STRONG BP<br />

1958<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

EUROPEAN COMMUNITY<br />

SWITZERLAND<br />

TOPICAL SOLUTION N/A THORNTON & ROSS LTD UNITED KINGDOM<br />

IODINE TINCTURE BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM<br />

IODIO, ALCOHOLIC CUTANEOUS<br />

SOLUTION<br />

ALCOHOLIC<br />

CUTANEOUS SOL<br />

N/A LABORATORIO CHIMICO<br />

FARMACEUTIC A. SELLA<br />

S.R.L<br />

ITALY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 595<br />

Trade Name Dosage Form Dose MA Holder Country<br />

IOPAMIRO (100ML) SOLUTION FOR IV<br />

INFUSION<br />

IOPAMIRO (50ML) SOLUTION FOR IV<br />

INFUSION<br />

NA BRACCO S.P.A ITALY<br />

NA BRACCO S.P.A ITALY<br />

IOPIDINE 0.5% OPHTHALMIC SOLUTION 0.5% W/V S.A. ALCON-COUVREUR<br />

N.V.<br />

BELGIUM<br />

IPECAVOM SYRUP 1000MG/15ML ELPEN S.A GREECE<br />

IPERTON TABLETS N/A KLEVA LTD GREECE<br />

IPOLIPID 600MG TABLET 600MG MEDOCHEMIE LTD CYPRUS<br />

IPRACIP - 20 INHALER AEROSOL CANISTER 20 MCG M/S. MEDISPRAY<br />

LABORATORIES PVT. LTD<br />

— GOA<br />

IPRAGOCCE OPHTHALMIC SOLUTION NA PROGE FARMA SRL ITALY<br />

IPRATROPIUM STERI-NEB SOLUTION FOR<br />

NEBULISATION<br />

IPRATROPIUM STERI-NEB<br />

500MCG/2ML<br />

SOLUTION FOR<br />

NEBULISATION<br />

INDIA<br />

250MCG/1ML STERIPAK LIMITED UNITED KINGDOM<br />

500MCG/2ML STERIPAK LIMTIED UNITED KINGDOM<br />

IPRAVENT INHALER INHALER 20MCG CIPLA LIMITED INDIA<br />

IPRAVENT INHALER INHALER 4MG CIPLA LTD — INDIA INDIA<br />

IPROBEN 200 LACTAB 200MG MEPHA PHARMA AG SWITZERLAND<br />

IRFEN LACTAB 200MG MEPHA PHARMA AG SWITZERLAND<br />

IRONORM CAPSULES N/A WALLACE<br />

MANUFACTURING<br />

CHEMISTS LIMITED<br />

ISLA-MINT HERBAL LOZENGES 100,00MG ENGELHARD<br />

ARZNEIMITTEL GMBH &<br />

CO. KG<br />

ISLA-MOOS HERBAL LOZENGES LOZENGES 80MG ENGELHARD<br />

ARZNEIMITTEL GMBH &<br />

CO. KG<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

ISMELIN EYE DROPS 50MG/ML CIBA VISION AG SWITZERLAND<br />

ISMO TABLETS 20MG ROCHE PRODUCTS<br />

LIMITED<br />

ISMO 20 TABLET 20MG HOFFMANN-LA ROCHE<br />

AG<br />

UNITED KINGDOM<br />

GERMANY<br />

ISMO 20 TABLET 20MG ROCHE PAKISTAN<br />

ISMO 20 TABLET 20MG ROCHE PAKISTAN<br />

LIMITED<br />

PAKISTAN<br />

ISMONIT 20 TABLET 20MG HEXAL AG GERMANY<br />

ISO MACK RETARD 20MG CAPSULE WITH SUST.<br />

ACTION<br />

ISO MACK RETARD 40MG CAPSULE WITH SUST<br />

RELEASE<br />

20MG HEINRICH MACK NACHF GERMANY<br />

40MG HEINRICH MACK NACHF GERMANY<br />

ISO MACK SPRAY SOLUTION 1.25MG/0.09ML HEINRICH MACK NACHF GERMANY


EN<br />

596 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ISOCARD TABLETS 10MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

ISOFLURANE LIQUID FOR<br />

INHALATION<br />

ISOGEL GRANULES FOR ORAL<br />

SOLN.<br />

ISOKET SOLUTION 0.1% SOLUTION FOR<br />

INFUSION<br />

>99.9% HALOCARBON<br />

LABORATORIES<br />

90% W/W UNICLIFFE LIMITED T/A<br />

PFIZER CONSUMER<br />

HEALTHCARE<br />

JORDAN<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

0.1% SCHWARZ PHARMA AG GERMANY<br />

ISONIAZID 100MG TABLETS PHARMAMED LTD. MALTA<br />

ISONIAZID TABLETS 300MG PHARMAMED LTD. MALTA<br />

ISOPRENALINE HCL INJECTION<br />

MINIJET<br />

SOLUTION FOR<br />

INJECTION<br />

ISOPRENALINE HCL MINIJET SOLUTION FOR<br />

INJECTION<br />

ISOPRENALINE INJ MINIJET<br />

0.002%W/V<br />

20MCG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

0.002%W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

AQUEOUS SOLUTION 20MCG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

ISOPRINOSINE TABLET 500MG NEWPORT SYNTHESIS<br />

LTD.<br />

ISOPRINOSINE SYRUP 250MG/5ML NEWPORT SYNTHESIS<br />

LTD.<br />

ISOPROTERENOL<br />

HYDROCHLORIDE USP.1:5000<br />

SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

0.2MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

ISOPTO CARPINE 1% OPHTHALMIC SOLUTION 10MG/ML S.A. ALCON-COUVREUR<br />

N.V.<br />

ISOPTO CARPINE 2% OPHTHALMIC SOLUTION 2% W/V S.A. ALCON-COUVREUR<br />

N.V.<br />

ISOPTO CARPINE 4% OPHTHALMIC SOLUTION 4% W/V S.A. ALCON-COUVREUR<br />

N.V.<br />

ISOPTO FENICOL 0.5% OPHTHALMIC SOLUTION 5MG/ML S.A. ALCON-COUVREUR<br />

N.V.<br />

ISOPTO FENICOL<br />

0.5%/CHLORAMPHENICOL 0.5%<br />

OPHTHALMIC SOLUTION 0.5% W/V S.A. ALCON-COUVREUR<br />

N.V.<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

ISORDIL TABLET 10MG WYETH LEDERLE PAKISTAN<br />

ISORDIL TABLET 10MG WYETH-LEDERLE PAKISTAN<br />

ISORDIL TAB 10MG TABLET 10MG WYETH-AYERST<br />

CANADA INC.<br />

ISORDIL TAB 5MG SUBLINGUAL TABLET 5MG WYETH-AYERST<br />

CANADA INC.<br />

CANADA<br />

CANADA<br />

ISOSORBIDE DINITRATE TABLETS 10MG PHARMAX LIMITED UNITED KINGDOM<br />

ISOSORBIDE DINITRATE TABLET 20MG PHARMAX LIMITED UNITED KINGDOM<br />

ISOSORBIDE MONONITRATE TABLETS 10MG PHARMAX LIMITED UNITED KINGDOM<br />

ISOSORBIDE MONONITRATE TABLET 20MG PHARMAX LIMITED UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 597<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ISOSORBIDE MONONITRATE TABLET 40MG PHARMAX LIMITED UNITED KINGDOM<br />

ISOSORBIDE MONONITRATE TABLETS 10MG NORTON HEALTHCARE<br />

LIMITED<br />

ISOSORBIDE MONONITRATE TABLETS 20MG NORTON HEALTHCARE<br />

LIMITED<br />

ISOSORBIDE MONONITRATE TABLETS 40MG NORTON HEALTHCARE<br />

LIMITED<br />

ISOTREX GEL GEL 0.05% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

ISOVIST-300 SOLN FOR INJ. AND<br />

ORAL USE<br />

ISPAGEL POWDER FOR ORAL<br />

SUSPENSION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

640.75MG/ML SCHERING AG GERMANY<br />

NA RICHMOND<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

ISTIN TABLET 10MG PFIZER LIMITED UNITED KINGDOM<br />

ISTIN TABLET 5MG PFIZER LIMITED UNITED KINGDOM<br />

ITASPOR CAPSULES 100MG INTAS<br />

PHARMACEUTICALS LTD<br />

ITASPOR (ITRACONAZOLE<br />

CAPSULES 100MG)<br />

IV-GLOBULIN (1,000MG) POWDER FOR<br />

RECONSTITUTION<br />

IV-GLOBULIN (2,500MG) POWDER FOR<br />

RECONSTITUTION<br />

CAPSULE 100MG INTAS<br />

PHARMACEUTICALS LTD<br />

N/A KOREA GREEN CROSS<br />

CORP.<br />

N/A KOREA GREEN CROSS<br />

CORP.<br />

IXEL CAPSULE 25MG LABORATOIRES PIERRE<br />

FABRE MEDICAMENT<br />

IXEL CAPSULE 50MG LABORATOIRES PIERRE<br />

FABRE MEDICAMENT<br />

IXENSE SUBLINGUAL TABLETS 2MG TAKEDA EUROPE R&D<br />

CENTRE LIMITED<br />

IXENSE SUBLINGUAL TABLETS 3MG TAKEDA EUROPE R&D<br />

CENTRE LIMITED<br />

INDIA<br />

INDIA<br />

KOREA REPUBLIC<br />

KOREA REPUBLIC<br />

FRANCE<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

JACKSON'S HERBAL LAXATIVE SYRUP N/A ANGLIAN PHARMA PLC UNITED KINGDOM<br />

JECTOFER SOLUTION FOR<br />

INJECTION<br />

50MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

JODOPLEX LIQUID SOAP N/A G.STREULI & CO. AG SWITZERLAND<br />

JODOPLEX OINTMENT N/A G.STREULI & CO.AG SWITZERLAND<br />

JODOPLEX SOLUTION 10MG/ML G.STREULI & CO. AG SWITZERLAND<br />

JOINT AND MUSCLE BALSAM OINTMENT N/A AH EHRLICH GMBH & CO<br />

KG<br />

JOINT AND MUSCLE BALSAM,<br />

EHRLICH BALSAM OI<br />

OINTMENT NA AH EHRLICH GMBH &<br />

CO. KG<br />

JOY RIDES TABLETS 0.075%W/W STAFFORD MILLER<br />

LIMITED<br />

JOY-RIDES TABLET 0.075 W/W STAFFORD-MILLER<br />

LIMITED<br />

GERMANY<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

598 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

JUMEX 5MG TABLET 5MG SEARLE PAKISTAN<br />

JUNIFEN SUSPENSION ORAL SUSPENSION 100MG/5ML CROOKES HEALTHCARE<br />

LIMITED<br />

JUNIOR IBUPROFEN SUPENSION ORAL SUSPENSION 100MG/5ML GALPHARM<br />

HEALTHCARE LIMITED<br />

JUNIOR MELTUS FOR CHESTY<br />

COUGHS AND CATARR<br />

JUNIOR MELTUS FOR DRI TICKLY<br />

COUGHS AND CA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM<br />

ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM<br />

JUNIOR MELTUS NIGHT TIME SYRUP N/A CUPAL LIMITED UNITED KINGDOM<br />

JUNIOR MELTUS SUGAR AND<br />

COLOR FREE EXPECTO<br />

JUNIOR PARAPAED<br />

PARACETAMOL SUSPENSION<br />

ORAL LIQUID N/A CUPAL LIMITED UNITED KINGDOM<br />

ORAL SUSPENSION 120MG/5ML PINEWOOD<br />

LABORATORIES LIMITED<br />

T/A PINEWOOD<br />

HEALTHCARE LIMITED<br />

KABIKINASE POWDER FOR INFUSION 25000IU/VIAL PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

KABIKINASE POWDER FOR INFUSION 1500000IU/VIAL PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

UNITED KINGDOM<br />

SWEDEN<br />

SWEDEN<br />

KALETRA CAPSULES NA ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

KALETRA ORAL SOLUTION NA ABBOTT LABORATORIES<br />

LIMITED<br />

KALETRA SOFT GELATIN CAPSULES NA ABBOTT LABORATORIES<br />

LIMITED<br />

KALI SULPH 6X NEW ERA<br />

BIOCHEMIC NO.7<br />

KALI. MUR. 6X NEW ERA<br />

BIOCHEMIC NO.5<br />

TISSUE SALT TABLETS<br />

NO.7<br />

TISSUE SALT TABLETS<br />

NO.5<br />

NA NEW ERA<br />

LABORATORIES LIMITED<br />

NA NEW ERA<br />

LABORATORIES LIMITED<br />

KALMIREN 10 TABLETS 10MG AEGIS LTD. CYPRUS<br />

KALMIREN 5 TABLETS 5MG AEGIS LTD. CYPRUS<br />

KALMS TABLETS COATED TABLET N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

KALPIREN TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

KALPIREN 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

KALTEN CAPSULE N/A ZENECA LIMITED UNITED KINGDOM<br />

KAMAGRA-100 FILM COATED TABLET 100MG AJANTA PHARMA LTD. INDIA<br />

KAMAGRA-50 FILM COATED TABLET 50MG AJANTA PHARMA LTD. INDIA<br />

KAMILLOSAN OINTMENT 10.5%W/W NORGINE LIMITED UNITED KINGDOM<br />

KAMILLOSAN OINTMENT 10.5%W/W GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

KAMISTAD-GEL GEL N/A STADAPHARM GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 599<br />

Trade Name Dosage Form Dose MA Holder Country<br />

KANAMYCIN-POS EYE DROPS 6.2MG/ML URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

KANAMYCIN-POS EYE OINTMENT 6.2MG/G URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

KAOLIN AND MORPHINE<br />

MIXTURE BP<br />

KAOLIN AND MORPHINE<br />

MIXTURE BP<br />

ORAL SOLUTION N/A WILLIAM RANSOM &<br />

SON PLC<br />

GERMANY<br />

GERMANY<br />

UNITED KINGDOM<br />

ORAL SOLUTION N/A LCM LTD UNITED KINGDOM<br />

KAPARLON-S TAB. 5MG TABLET 5MG ANFARM HELLAS S.A.-<br />

PHARMACEUTICALS<br />

GREECE<br />

KAPARLONS-S TABLETS 20MG ANFARM HELLAS S.A. GREECE<br />

KARDEGIC 160MG POWDER FOR ORAL<br />

SOLUTION<br />

KARDEGIC 300MG POWDER FOR ORAL<br />

SOLUTION<br />

KARVOL DECONGESTANT<br />

CAPSULES<br />

POWD. FOR<br />

INHALATION SOLN<br />

160MG LABORATOIRES<br />

SYNTHELABO<br />

300MG LABORATOIRES<br />

SYNTHELABO<br />

N/A CROOKES HEALTHCARE<br />

LIMITED<br />

KATAVAL CREAM NA FARMIGEA SPA ITALY<br />

KATOXYN POWDER SPRAY N/A DEVERGE' MEDICINA E<br />

MEDICALIZZAZIONE SRL<br />

K-COR-5 TABLET 5MG MACLEODS INDIA<br />

KEFLEX CAPSULE 250MG ELI LILLY ITALIA S.P.A. ITALY<br />

KEFLEX CAPSULE 500MG ELI LILLY ITALIA S.P.A. ITALY<br />

KEFLEX GRANULES FOR ORAL<br />

SUSPEN.<br />

FRANCE<br />

FRANCE<br />

UNITED KINGDOM<br />

ITALY<br />

125MG/5ML ELI LILLY ITALIA S.P.A. ITALY<br />

KEFLIN NEUTRO POWDER FOR INJECTION 1000MG ELI LILLY ITALIA S.P.A. ITALY<br />

KEFORAL HARD CAPSULE 250MG ELI LILLY ITALIA S.P.A. ITALY<br />

KEFORAL HARD CAPSULE 500MG ELI LILLY ITALIA S.P.A. ITALY<br />

KEFTID POWDER FOR ORAL<br />

SUSPENSIO<br />

KEFTID POWDER FOR ORAL<br />

SUSPENSIO<br />

125MG/5ML GALEN LIMITED UNITED KINGDOM<br />

250MG/5ML GALEN LIMITED UNITED KINGDOM<br />

KEFTID CAPSULES 500MG GALEN LIMITED UNITED KINGDOM<br />

KEFTID CAPSULES 250MG GALEN LIMITED UNITED KINGDOM<br />

KEFUROX POWDER FOR INJECTION 1500MG ELI LILLY ITALIA S.P.A. ITALY<br />

KEFUROX POWDER FOR INJECTION 750MG ELI LILLY ITALIA S.P.A. ITALY<br />

KEFUROX POWDER FOR INJECTION 250MG ELI LILLY ITALIA S.P.A. ITALY<br />

KEMADRIN TABLETS 5MG THE WELLCOME<br />

FOUNDATION LTD.<br />

KEMADRIN SOLUTION FOR<br />

INJECTION<br />

5MG/ML THE WELLCOME<br />

FOUNDATION LTD.<br />

KEMADRIN TABLETS 5MG GLAXOSMITHKLINE<br />

GMBH & CO KG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY


EN<br />

600 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

KEMADRIN INJECTION 10MG/2ML SOLUTION FOR<br />

INJECTION<br />

0.5% W/V THE WELLCOME<br />

FOUNDATION LIMITED<br />

KENACOMB CREAM N/A BRISTOL-MYERS SQUIBB<br />

S.P.A<br />

KENACOMB OINTMENT N/A BRISTOL-MYERS SQUIBB<br />

S.P.A<br />

KENACORT INJECTABLE SUSPENSION 40MG/ML BRISTOL MYERS SQUIBB<br />

S.P.A.<br />

KENACORT ‘A RETARD’ SOLUTION FOR<br />

INJECTION<br />

40MG/ML BRISTOL MYERS SQUIBB<br />

S.P.A<br />

KENALOG IN ORABASE PASTE 0.1G/100G SQUIBB INDUSTRIA<br />

FARMACEUTICA, S.A.<br />

KEPPRA FILM-COATED TABLETS 250MG UCB S.A.(PHARMA<br />

SECTOR)<br />

KEPPRA FILM-COATED TABLETS 500MG UCB S.A.(PHARMA<br />

SECTOR)<br />

KEPPRA FILM-COATED TABLETS 1000MG UCB S.A.(PHARMA<br />

SECTOR)<br />

KESTIN 10MG FILM COATED TABLET 10MG LABS SPECIA FRANCE<br />

KETEK TABLETS 400MG AVENTIS PHARMA S.A. FRANCE<br />

KETESSE TABLET 25MG MENARINI<br />

INTERNATIONAL<br />

OPERATIONS<br />

LUXEMBOURG S.A.<br />

KETODOL TABLET N/A ALFA WASSERMANN<br />

S.P.A.<br />

KETOFTIL EYE DROPS 0.05% FARMIGEA SPA ITALY<br />

KETOFTIL OPHTHALMIC GEL 0.05% FARMIGEA SPA ITALY<br />

KETOFTIL OPHTHALMIC GEL 0.05% FARMIGEA SPA ITALY<br />

KETORAL MEDICAL SHAMPOO N/A BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

KETORAL MEDICAL SHAMPOO SHAMPOO N/A BILIM ILAC SANAYII VE<br />

TICARET A.S<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

SPAIN<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

ITALY<br />

ITALY<br />

TURKEY<br />

TURKEY<br />

KETRAX TABLETS 47.2MG ZENECA LIMITED UNITED KINGDOM<br />

KETRAX SYRUP 0.944% W/V ZENECA LIMITED UNITED KINGDOM<br />

KETRAX COATED TABLETS 40MG ZENECA LIMITED UNITED KINGDOM<br />

KETRAX SYRUP ORAL SOLUTION 40MG/5ML ZENECA LIMITED UNITED KINGDOM<br />

KIDDI PHARMATON SYRUP N/A PHARMATON SA SWITZERLAND<br />

KIDDI PHARMATON (KIDDI<br />

PHARMATON FIZZ)<br />

EFFERVESCENT TABLET N/A PHARMATON SA SWITZERLAND<br />

KINUSSEN TABLETS 10MG KLEVA LTD GREECE<br />

KLACID GRANULES FOR ORAL<br />

SUSP.<br />

125MG/5ML ABBOTT AG ITALY<br />

KLACID FILMTAB TABLETS 250MG ABBOTT AG SWITZERLAND


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 601<br />

Trade Name Dosage Form Dose MA Holder Country<br />

KLACID TABLETS 250MG ABBOTT S.P.A ITALY<br />

KLACID GRANULES FOR<br />

SUSPENSION<br />

125MG/5ML ABBOTT S.P.A. ITALY<br />

KLACID COATED TABLET 500MG ABBOTT SPA ITALY<br />

KLACID LA MODIFIED RELEASE<br />

TABLETS<br />

500MG ABBOTT LABORATORIES<br />

(IRELAND) LTD<br />

KLACID RM SR COATED TABLETS 500MG ABBOTT S.P.A. ITALY<br />

KLACID XL TABLETS 500MG ABBOTT LABORATORIES<br />

S.A (PTY)<br />

KLACID XL TABLETS MODIFIED RELEASE<br />

TABLETS<br />

KLAMOKS 156.25MG PED. POWDER FOR O.<br />

SUSPEN<br />

KLAMOKS 156.25MG PAEDIATRIC DRY POWDER FOR ORAL<br />

SUSP.<br />

500MG ABBOTT LABORATORIES<br />

S.A (PTY) LIMITED<br />

N/A BILIM ILAC SANAYII VE<br />

TICARET A.S<br />

N/A BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

KLAMOKS 625MG FILM COATED TABLETS N/A BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

KLAMOKS 625MG FILM COATED TABLET N/A BILIM ILAC SANAYII VE<br />

TICARET A.S<br />

KLAMOKS BID TABLETS 1000MG BILIM ILAC SANAYII VE<br />

TICARET A.S<br />

KLAMOKS BID 200/28MG DRY POWDER FOR ORAL<br />

SUSP.<br />

KLAMOKS BID FORTE 200/28MG POWDER FOR OR.<br />

SUSPENSION<br />

KLAMOKS BID FORTE 400/57MG DRY POWDER FOR ORAL<br />

SUSP.<br />

KLAMOKS BID FORTE 400/57MG POWDER FOR OR.<br />

SUSPENSION<br />

N/A BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

N/A BILIM ILAC SANAYII VE<br />

TICARET A.S<br />

N/A BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

N/A BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

KLAMOKS-BID 1000MG FILM COATED TABLET N/A BILIM ILAC SANAYI VE<br />

TICARET A.S<br />

IRELAND<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

TURKEY<br />

TURKEY<br />

TURKEY<br />

TURKEY<br />

TURKEY<br />

TURKEY<br />

TURKEY<br />

TURKEY<br />

TURKEY<br />

TURKEY<br />

KLARICID TABLET 250MG ABBOTT PAKISTAN<br />

KLARICID COATED TABLETS 500MG ABBOTT LABORATORIES<br />

LIMITED<br />

KLARICID 500MG IV POWDER FOR IV<br />

INJECTION<br />

500MG ABBOTT LABORATORIES<br />

LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

KLARICID XL TABLET 500MG ABBOTT PAKISTAN<br />

KLARICID XL 500MG MODIFIED RELEASE<br />

TABLETS<br />

500MG ABBOTT LABORATORIES<br />

LIMITED<br />

UNITED KINGDOM<br />

KLEAN PREP POWDER N/A NORGINE LIMITED UNITED KINGDOM<br />

KLEAN-PREP ORAL POWDER N/A HELSINN BIREX<br />

PHARMACEUTICALS LTD.<br />

IRELAND<br />

KLERIMED TABLETS 250MG MEDOCHEMIE LIMITED CYPRUS<br />

KLEVASIN CAPSULE 500MG KLEVA LTD. GREECE


EN<br />

602 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

KLEVASIN POWDER FOR ORAL<br />

SUSP.<br />

500MG/5ML KLEVA LTD GREECE<br />

KLEVISTAMIN TABLET 1MG KLEVA<br />

PHARMACEUTICAL<br />

LABORATORIES LTD<br />

KLEVISTAMIN SYRUP 1MG/5ML KLEVA<br />

PHARMACEUTICAL<br />

LABORATORIES LTD<br />

GREECE<br />

GREECE<br />

KLEVISTAMIN TABLETS 1MG KLEVA LIMITED GREECE<br />

KLEVISTAMIN SYRUP 1MG/5ML KLEVA LIMITED GREECE<br />

KLIACEF GRANULES FOR ORAL<br />

SUSP.<br />

5% W/V FONTEN FARMACEUTICI<br />

S.R.L.<br />

KLIACEF CAPSULE 500MG FONTEN FARMACEUTICI<br />

S.R.L.<br />

KLIACEF TABLET 500MG FONTEN FARMACEUTICI<br />

S.R.L.<br />

KLINDAM CAPSULE 150MG PRIME<br />

PHARMACEUTICAL<br />

SDN.BHD.<br />

KLINDAN CAPSULE 150MG BILIM ILAC CANAYII VE<br />

TICARET SA<br />

KLINDAN 300MG AMPUL SOLUTION FOR<br />

INJECTION<br />

300MG/2ML BILIM ILAC SANAYII VE<br />

TICARET A.S<br />

ITALY<br />

ITALY<br />

ITALY<br />

MALAYSIA<br />

TURKEY<br />

TURKEY<br />

KLIOGEST -28 TABLETS TABLET NA NOVO NORDISK A/S DENMARK<br />

KLISMACORT RECTAL CAPSULES 100MG BENE-ARZNEIMITTEL<br />

GMBH<br />

GERMANY<br />

KLONT 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS<br />

KLOVIREKS 250MG POWDER FOR INJECTION 250MG MUSTAFA NEVZAT ILAC<br />

SANAYII A.S.<br />

KLOVIREKS-L ENJEKTABL FREEZE-DRIED POW.F/INJ. 250MG MUSTAFA NEVZAT ILAC<br />

SANAYII A.S.<br />

KOATE-DVI (ANTIHEMOPHILIC<br />

FACTOR, HUMAN)<br />

KONSYL-ORANGE SUGAR FREE POWDER FOR ORAL<br />

SUSP.<br />

POWDER FOR INJECTION 9-22IU/MG PROT. BAYER CORPORATION,<br />

PHARMACEUTICAL DIV.<br />

60.3% W/W EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

TURKEY<br />

TURKEY<br />

KRATIUM 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS<br />

KRATIUM 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

KROTER CREAM CREAM 10% W/W CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

KYTRIL FILM COATED TABLETS 1MG ROCHE PHARMA<br />

SCHWEIZ LTD.<br />

KYTRIL INFUSION 3MG/3ML SOLUTION FOR<br />

INJECTION<br />

3MG/3ML SMITHKLINE BEECHAM<br />

PLC<br />

KYTRIL PAEDIATRIC LIQUID ORAL LIQUID 200MCG/ML SMITHKLINE BEECHAM<br />

PLC<br />

KYTRIL TABLETS 1MG COATED TABLET 1MG SMITHKLINE BEECHAM<br />

PLC<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

MALAYSIA<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 603<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LABETALOL TABLETS 200MG COATED TABLET 200MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

LABOSEPT PASTILLES 0.25MG LOZENGE 0.25MG LABORATORIES FOR<br />

APPLIED BIOLOGY LTD<br />

LACIPIL TABLETS 4MG GALXO WELLCOME S.A. SPAIN<br />

LACIPIL 4MG TABLETS FILM COATED TABLET 4MG GLAXO WELLCOME S.A. SPAIN<br />

LACRIGEL OPHTHALMIC GEL N/A FARMIGEA SPA ITALY<br />

LACRINORM OPHTHALMIC GEL N/A FARMIGEA SPA ITALY<br />

LACTATED RINGERS AND 5%<br />

DEXTROSE INJ.<br />

SOLUTION FOR<br />

INJECTION<br />

LACTATED RINGER'S INJECTION SOLUTION FOR IV<br />

INFUSION<br />

LACTATED RINGERS INJECTION<br />

DEMO<br />

LACTATED RINGERS INJECTION<br />

USP<br />

LACTATED RINGER'S INJECTION,<br />

USP<br />

SOLUTION FOR<br />

INFUSION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR IV<br />

INFUSION<br />

UNITED KINGDOM<br />

NA ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

N/A DEMO SA GREECE<br />

NA DEMO SA GREECE<br />

NA ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

LACTEOL FORT CAPSULE N/A LABORATOIRE DU<br />

LACTEOL DU DOCTEUR<br />

BOUCARD<br />

LACTEOL FORT SACHET POWDER FOR ORAL<br />

SUSPEN.<br />

LACTICARE (FORMERLY K/A<br />

OILATUM LOTION)<br />

N/A LABORATOIRE DU<br />

LACTEOL DU DOCTEUR<br />

BOUCARD<br />

TOPICAL EMULSION N/A STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

LACTO CALAMINE LOTION TOPICAL SUSPENSION N/A SCHERING-PLOUGH<br />

LIMITED<br />

LACTULOSE SOLUTION (LAXOSE) ORAL SOLUTION 3.35G/5ML APPROVED<br />

PRESCRIPTION SERVICES<br />

LIMITED<br />

LAMETEC-100 TABLET 100MG CIPLA INDIA<br />

LAMICTAL TABLETS 25MG THE WELLCOME<br />

FOUNDATION LTD.<br />

LAMICTAL TABLETS 50MG THE WELLCOME<br />

FOUNDATION LTD.<br />

LAMICTAL TABLETS 100MG THE WELLCOME<br />

FOUNDATION LTD.<br />

LAMICTAL TABLETS 100MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

LAMICTAL TABLET 25MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

LAMICTAL TABLETS 50MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

LAMICTAL DISPERSIBLE TABLET FOR ORAL<br />

SOLUTION<br />

LAMICTAL DISPERSIBLE 25MG<br />

TABLETS<br />

TABLET FOR ORAL<br />

SOLUTION<br />

5MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

25MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

FRANCE<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

604 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LAMICTAL DISPERSIBLE 5MG<br />

TABLETS<br />

TABLETS FOR ORAL<br />

SOLUTION<br />

5MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

UNITED KINGDOM<br />

LAMICTAL TABLETS TABLETS 25MG GLAXOWELLCOME PAKISTAN<br />

LAMICTAL TABLETS TABLETS 100MG GLAXOWELLCOME PAKISTAN<br />

LAMIFEN TABLETS 250 MG TABLET 250MG ALFARES<br />

PHARMACEUTICALS<br />

LAMIFIN TABLET 250MG ALFARES<br />

PHARMACEUTICALS<br />

LAMIFIN 1% CREAM 1% W/W ALFARES<br />

PHARMACEUTICALS<br />

LAMIFIN CREAM 1% CREAM 10MG/G ALFARES<br />

PHARMACEUTICALS<br />

LAMISIL TOPICAL SOLUTION 10MG/G NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LAMISIL SPRAY 10MG/G NOVARTIS PHARMA<br />

(SCHWEIZ) AG<br />

LAMISIL DERMGEL 10MG/G NOVARTIS PHARMA<br />

(SCHWEIZ) AG<br />

LAMISIL TABLETS 250MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LAMISIL CREAM 1% W/W NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SYRIA<br />

SYRIA<br />

SYRIA<br />

SYRIA<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

LAMISIL CREAM 10MG/G NOVARTIS PAKISTAN<br />

LAMISIL TABLETS 125MG NOVARTIS PAKISTAN<br />

LAMISIL TOPICAL SOLUTION 10MG/G NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LAMISIL SPRAY 10MG/G NOVARTIS PHARMA<br />

(SCHWEIZ) AG<br />

LAMISIL CREAM 1% W/W NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LAMISIL TABLETS 250MG NOVARTIS FARMA SPA ITALY<br />

LAMOTRIGINE DISPERSIBLE TABLET FOR ORAL<br />

SOLUTION<br />

25MG THE WELLCOME<br />

FOUNDATION LTD.<br />

LANACANE CREME CREAM 3%W/W COMBE INTERNATIONAL<br />

LIMITED<br />

LANES MOD. HERB. COLD AND<br />

CATARRH TABLETS.<br />

LANES MOD. HERB. RHEUMATIC<br />

PAIN TABLETS<br />

LANES MOD. HERB. TRAPPED<br />

WIND AND INDIGEST<br />

LANES MOD. HERB. WATER<br />

RETENTION TABS.<br />

LANES MOD. HERBALS SLEEP AID<br />

PASSIFLORA<br />

LANES MOD. HERBALS STRESS<br />

TABLETS<br />

COATED TABLET N/A MODERN HEALTH<br />

PRODUCTS<br />

COATED TABLET N/A MODERN HEALTH<br />

PRODUCTS LTD<br />

TABLET 125MG G R LANE HEALTH<br />

PRODUCTS LTD<br />

COATED TABLET N/A MODERN HEALTH<br />

PRODUCTS LTD<br />

TABLET 22MG G R LANE HEALTH<br />

PRODUCTS<br />

COATED TABLET N/A METABASIC PRODUCTS<br />

LTD<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 605<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LANES MODERN HERBALS COLD<br />

AND CONGESTION<br />

LANES MODERN HERBALS<br />

COUGH MIXTURE<br />

LANES MODERN HERBALS FOOT<br />

BALM<br />

LANES MODERN HERBALS<br />

LAXATIVE TABLETS<br />

LANES MODERN HERBALS<br />

MENOPAUSE TABLET<br />

LANES MODERN HERBALS<br />

MUSCULAR PAIN CREAM<br />

LANES MODERN HERBALS PILE<br />

OINTMENT<br />

LANES MODERN HERBALS PILE<br />

TABLETS<br />

ORAL SOLUTION N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

ORAL SOLUTION N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

OINTMENT N/A G R LANE HEALTH<br />

PRODUCT LTD<br />

COATED TABLET N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

COATED TABLET N/A METABASIC PRODUCTS<br />

LTD<br />

CREAM N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

OINTMENT N/A G R LANE HEALTH<br />

PRODUCTS<br />

COATED TABLET N/A GR LANE HEALTH<br />

PRODUCTS LTD<br />

LANOXIN TABLETS 250MCG THE WELLCOME<br />

FOUNDATION LTD.<br />

LANOXIN ELIXIR N/A GLAXO WELLCOME<br />

GMBH & CO<br />

LANOXIN — PG TABLETS TABLETS 62.5MCG THE WELLCOME<br />

FOUNDATION LTD.<br />

LANOXIN INJECTION 1.25MG/5ML SOLUTION FOR<br />

INJECTION<br />

0.025% W/V THE WELLCOME<br />

FOUNDATION LIMITED<br />

LANOXIN PAEDIATRIC ELIXIR ELIXIR 0.05G/1000ML THE WELLCOME<br />

FOUNDATION LTD.<br />

LANOXIN PG DIGOXIN 62.5MCG<br />

TABLETS<br />

TABLET 62.5MCG SIGMA<br />

PHARMACEUTICALS PTY<br />

LTD.<br />

LANOXIN TABLET 250 MCG TABLET 0.25MG GLAXOSMITHKLINE<br />

GMBH & CO. LTD<br />

LANSOX CAPSULE 15MG TAKEDA ITALIA<br />

FARMACEUTICI S.P.A.<br />

LANSOX CAPSULE 30MG TAKEDA ITALIA<br />

FARMACEUTICI S.P.A.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

GERMANY<br />

LANSOYL 78.23% ORAL JELLY 78.23% W/W PARKE DAVIS FRANCE<br />

LANTANON TABLETS TABLET 30MG ORGANON PAKISTAN<br />

LANTIGEN B ORAL DROPS,<br />

SUSPENSION<br />

ITALY<br />

ITALY<br />

N/A BRUSCHETTINI SRL ITALY<br />

LANVIS TABLETS 40MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

LANVIS TABLETS 40MG TABLETS 40MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

LARGACTIL SOLUTION FOR<br />

INJECTION<br />

LARGACTIL INJECTION 2.5% W/V SOLUTION FOR<br />

INJECTION<br />

2.5% W/V HAWGREEN LTD. IRELAND<br />

2.5% W/V HAWGREEN LIMITED IRELAND<br />

LARGACTIL SYRUP 25MG/5ML ORAL SOLUTION 25MG/5ML HAWGREEN LIMITED IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

606 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LARGACTIL TABLETS 100MG COATED TABLET 100MG HAWGREEN LIMITED IRELAND<br />

LARGACTIL TABLETS 25MG COATED TABLET 25MG HAWGREEN LIMITED IRELAND<br />

LARGACTIL TABLETS 50MG COATED TABLET 50MG HAWGREEN LIMITED IRELAND<br />

LARGOPEN CAPSULE 250MG BILIM ILAC SANAYII VE<br />

TICARET AS<br />

LARGOPEN 125MG/5ML POWDER FOR ORAL<br />

SUSPEN.<br />

125MG/5ML BILIM ILAC SANAYII VE<br />

TICARET AS<br />

LARIAM TABLETS 250MG ROCHE PHARMA<br />

(SCHWEIZ)AG<br />

TURKEY<br />

TURKEY<br />

SWITZERLAND<br />

LARMABAK EYE DROPS N/A LABORATOIRESTHEA FRANCE<br />

LASILIX 20MG/2ML SOLUTION FOR<br />

INJECTION<br />

20MG/2ML LABORATOIRES<br />

HOECHST<br />

LASILIX 40MG TABLET 40MG LABORATOIRES<br />

HOECHST<br />

LASILIX RETARD 60MG SUSTAINED RELEASE<br />

CAPSULE<br />

60MG LABORATOIRES<br />

HOECHST<br />

LASILIX SPECIAL 500MG TABLET 500MG LABORATOIRES<br />

HOECHST<br />

LASIX TABLETS 40MG HOECHST MARION<br />

ROUSSEL<br />

LASIX 40MG TABLET 40MG HOECHST MARION<br />

ROUSSEL<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

PAKISTAN<br />

PAKISTAN<br />

LASONIL OINTMENT N/A BAYER PLC UNITED KINGDOM<br />

LASONIL OINTMENT 0.8% W/W BAYER PLC UNITED KINGDOM<br />

LASONIL N OINTMENT 5000 HDB-E/100G BAYER VITAL GMBH &<br />

CO. KG<br />

GERMANY<br />

LASOPROL 15 CAPSULES 15MG AEGIS LTD. CYPRUS<br />

LASOPROL 30 CAPSULES 30MG AEGIS LTD. CYPRUS<br />

LATAN-N TABLET N/A WYETH-AYERST<br />

CANADA INC<br />

LAXADIN (BISACODYL) TABLETS<br />

5MG<br />

TABLET 5MG TEVA<br />

PHARMACEUTICALS<br />

INDUSTRIES LTD<br />

LEDERFOLIN 15MG TABLETS TABLET 15 MG CYANAMID IBERICA S.A. SPAIN<br />

LEFUMIDE-10 FILM COATED TABLETS 10MG CIPLA LIMITED INDIA<br />

CANADA<br />

ISRAEL<br />

LEMLAX ORAL LIQUID 3.26G/5ML CO-PHARMA LIMITED UNITED KINGDOM<br />

LEMON ENO POWDER FOR ORAL<br />

SOLUTION<br />

N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

LEMSIP CHESTY COUGH LIQUID LIQUID 50MG/5ML RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

LEMSIP CHILDREN'S SIX+ COLD<br />

AND FLU RELIEF<br />

POWDER FOR ORAL<br />

SOLUTION<br />

N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 607<br />

LEMSIP COLD + FLU<br />

BLACKCURRANT<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LEMSIP COLD + FLU BREATHE<br />

EASY<br />

LEMSIP COLD + FLU MAX<br />

STRENGTH<br />

LEMSIP COLD + FLU MAX<br />

STRENGTH CAPSULES<br />

LEMSIP COLD + FLU ORIGINAL<br />

LEMON<br />

LEMSIP DRY TICKLY COUGH<br />

LIQUID<br />

POWDER FOR ORAL<br />

SOLUTION<br />

POWDER FOR ORAL<br />

SOLUTION<br />

POWDER FOR ORAL<br />

SOLUTION<br />

N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

CAPSULE N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

POWDER FOR ORAL<br />

SOLUTION<br />

N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

LIQUID N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

LEMSIP FLU STRENGTH POWDER POWDER N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

LEMSIP PHARMACY POWERCAPS MODIFIED RELEASE<br />

CAPSULE<br />

N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

LEMSIP POWDER POWDER N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

LEMSIP POWER + POWDER POWDER N/A RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

LEMSIP SORE THROAT<br />

ANTI-BACTERIAL<br />

LEMSIP SORE THROAT<br />

ANTI-BACTERIAL CITRUS<br />

LOZENGE 2.4MG ERNEST JACKSON & CO<br />

LIMITED<br />

LOZENGE 2.4MG ERNEST JACKSON & CO<br />

LIMITED<br />

LEN VK 250MG TABLET 250MG PHARMACARE LIMITED<br />

— SOUTH AFRICA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SOUTH AFRICA<br />

LENNON — DAPSONE 100MG TABLET 100MG PHARMACARE LIMITED SOUTH AFRICA<br />

LENOCEF -125 SUSPENSION SUSPENSION 125MG PHARMACARE LIMITED -<br />

SOUTH AFRICA<br />

LENOCEF-250 CAPSULES 250MG PHARMACARE LIMITED-<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

LENOLAX LIQUID NA PHARMACARE LIMITED REPUBLIC OF SOUTH<br />

AFRICA<br />

LEPONEX TABLETS 25MG NOVARTIS PHARMA<br />

GMBH<br />

LEPONEX TABLETS 100MG NOVARTIS PHARMA<br />

GMBH<br />

LEPONEX TABLETS 25MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LEPONEX TABLETS 100MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LEPONEX TABLETS 25MG NOVARTIS PHARMA<br />

SCHWEIZ<br />

LEPONEX TABLETS 100MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LEPONEX 100MG TABLETS 100MG NOVARTIS PHARM. UK.<br />

LTD. T/A SANDOZ<br />

PHARM.<br />

AUSTRIA<br />

AUSTRIA<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND


EN<br />

608 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LEPONEX 25MG TABLETS 25MG NOVARTIS PHARM. UK<br />

LTD. T/A SANDOZ<br />

PHARM.<br />

SWITZERLAND<br />

LEPUR FILM COATED TABLETS 5MG KLEVA LTD. GREECE<br />

LEPUR FILM COATED TABLETS 10MG KLEVA LTD. GREECE<br />

LEPUR FILM COATED TABLETS 20MG KLEVA LTD. GREECE<br />

LESCOL CAPSULES 20MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LESCOL CAPSULES 40MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

SWITZERLAND<br />

LESCOL CAPSULE 20MG NOVARTIS PAKISTAN<br />

LESCOL CAPSULES 40MG NOVARTIS<br />

FARMACEUTICA S.A<br />

LESCOL CAPSULES 20MG NOVARTIS<br />

FARMACEUTICA S.A<br />

LESCOL FORTE PROLONGED RELEASE<br />

TABLETS<br />

80MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LESCOL XL SLOW RELEASE TABLETS 80MG NOVARTIS<br />

FARMACEUTICA S.A<br />

LESCOL XL 80MG PROLONGED<br />

RELEASE TABLETS<br />

LEUCOVORIN CALCIUM FOLINIC<br />

ACID INJ. VIA<br />

FILM-COATED TABLETS 80 MG NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

SOLUTION FOR<br />

INJECTION<br />

LEUKERAN COMPRESSION-COATED<br />

TABLET<br />

LEUKERAN COMPRESSION-COATED<br />

TABLET<br />

50MG/ML F.H. FAULDING & CO.<br />

LTD (T/A DAVID BULL<br />

LABS)<br />

2MG THE WELLCOME<br />

FOUNDATION LTD.<br />

5MG THE WELLCOME<br />

FOUNDATION LTD.<br />

LEUKERAN TABLETS 2MG TABLET 2MG THE WELLCOME<br />

FOUNDATION LTD T/A<br />

GLAXO WELLCOME<br />

SPAIN<br />

SPAIN<br />

SWITZERLAND<br />

SPAIN<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

LEVOMED 100/10MG TABLET N/A MEDOCHEMIE LTD CYPRUS<br />

LEVOMED 250/25MG TABLET N/A MEDOCHEMIE LTD CYPRUS<br />

LEVOPHED SOLUTION FOR<br />

INJECTION<br />

LEVOPHED SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

1MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

4MG/4ML(1MG/ML) ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

LEVOPRONT SYRUP 0.6G/ML DOMPE FARMACEUTICI<br />

SPA<br />

LEVOVIST GRANULES FOR<br />

INJECTION<br />

ITALY<br />

N/A SCHERING AG GERMANY<br />

LEVSIN/SL TABLETS N/A SCHWARZ PHARMA INC UNITED STATES OF<br />

AMERICA<br />

LEXILIUM 6 TABLETS 6MG REMEDICA LTD CYPRUS<br />

LEXOMIL (BROMAZEPAM) TABLETS (30) 6MG ROCHE S.A. MOROCCO<br />

LEXOMIL 3MG TABLET 3MG PRODUIT ROCHE S.A. MOROCCO


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 609<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LIBERTY ASPIRIN TABLETS 300MG OBG PHARMACEUTICALS<br />

LTD<br />

LIBERTY PARACETAMOL TABLETS 500MG OBG PHARMACEUTICALS<br />

LTD<br />

LIBERTY 'PARACIN' FILM COATED TABLETS 500MG OBG PHARMACEUTICALS<br />

LTD<br />

LIBRIUM CAPSULES 10MG CAPSULES 10MG ICN PHARMACEUTICALS<br />

LTD<br />

LIBRIUM CAPSULES 5MG CAPSULES 5MG ICN PHARMACEUTICALS<br />

LTD<br />

LIBROFEM FILM COATED TABLET 200MG EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

LIBROFEM TABLETS FILM COATED TABLET 200MG EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

LIDOCAINE (LIGNOCAINE)<br />

LARYNGOJET<br />

LIDOCAINE (LIGNOCAINE)<br />

MINIJET<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

LIDOCAINE (LIGNOCAINE) MINJET SOLUTION FOR<br />

INJECTION<br />

LIDOCAINE 5%W/V AND<br />

PHENYLEPHRINE 0.5%W/V<br />

LIDOCAINE HCL AND<br />

EPINEPHRINE INJ USP<br />

4%W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

2%W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

1%W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

TOPICAL SOLUTION N/A AURUM<br />

PHARMACEUTICALS<br />

LIMITED<br />

SOLUTION FOR<br />

INJECTION<br />

LIDOCAINE HYDROCHLORIDE SOLUTION FOR<br />

INJECTION<br />

LIDOCAINE INJECTION MINIJET<br />

1%W/V<br />

LIDOCAINE INJECTION MINIJET<br />

2%W/V<br />

LIDOCAINE LARYNGOJET 4%W/V SOLUTION FOR TOPICAL<br />

USE<br />

LIDOCATON 2% 1:80 000 SOLUTION FOR<br />

INJECTION<br />

LIFESOL 0.9% (NACL) IV<br />

SOLUTION<br />

LIFESOL 5% I.V. SOLUTION<br />

(DEXTROSE 5%)<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NA ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

1G/50ML PHARMAMED<br />

PARENTERALS LTD.<br />

AQUEOUS SOLUTION 10MG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

AQUEOUS SOLUTION 20MG/1ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

SOLUTION FOR IV<br />

INJECTION<br />

SOLUTION FOR IV<br />

INJECTION<br />

LIFUROX POWDER FOR IV/IM<br />

INJECT.<br />

LIFUROX POWDER FOR IV/IM<br />

INJECT.<br />

4%W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

MALTA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

N/A WEIMER PHARMA GMBH GERMANY<br />

0.9% W/V GEOFMAN<br />

PHARMACEUTICALS<br />

5% W/V GEOFMAN<br />

PHARMACEUTICALS<br />

PAKISTAN<br />

PAKISTAN<br />

250MG ELI LILLY ITALIA S.P.A. ITALY<br />

750MG ELI LILLY ITALIA S.P.A. ITALY


EN<br />

610 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LIFUROX POWDER FOR IV/IM<br />

INJECT.<br />

LIGNOCAINE 0.5% WITH<br />

ADRENALINE<br />

LIGNOCAINE HCL INJ. WITH<br />

ADRENALINE<br />

1500MG ELI LILLY ITALIA S.P.A. ITALY<br />

AQUEOUS SOLUTION INJ N/A INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

SOLUTION FOR<br />

INJECTION<br />

LIGNOCAINE HYDROCHLORIDE SOLUTION FOR<br />

INJECTION<br />

LIGNOCAINE HYDROCHLORIDE SOLUTION FOR<br />

INJECTION<br />

LIGNOCAINE HYDROCHLORIDE<br />

INJECTION<br />

LIGNOCAINE HYDROCHLORIDE<br />

INJECTION<br />

LIGNOCAINE HYDROCHLORIDE<br />

INJECTION<br />

LIGNOCAINE HYDROCHLORIDE<br />

INJECTION<br />

LIGNOCAINE HYDROCHLORIDE<br />

INJECTION<br />

LIGNOCAINE HYDROCHLORIDE<br />

INJECTION<br />

LIGNOCAINE HYDROCHLORIDE<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTIONS<br />

SOLUTION FOR<br />

INJECTION<br />

LIGNOSPAN FORTE SOLUTION FOR<br />

INJECTION<br />

LIGNOSPAN SPECIAL SOLUTION FOR<br />

INJECTION<br />

LIGNOSPAN STANDARD SOLUTION FOR<br />

INJECTION<br />

N/A INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

2.% W/V ANTIGEN<br />

PHARMACEUTICALS LTD<br />

BP 1.0% W/V ANITGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

2%W/V ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

2%W/V ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

2%W/V ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

1%W/V ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

1%W/V ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

1%W/V ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

1%W/V ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

N/A DEPROCO INC. UNITED STATES OF<br />

AMERICA<br />

N/A LABORATOIRES<br />

SEPTODONT<br />

FRANCE<br />

N/A DEPROCO INC. UNITED STATES OF<br />

AMERICA<br />

LIMITROL TABLETS 10MG PHARMA EVO PAKISTAN<br />

LINCOCIN CAPSULES 500MG PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

LINCOCIN SOLUTION FOR<br />

INJECTION<br />

LINDASOL SOLUTION FOR<br />

EXTERNAL USE<br />

600MG/2ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

BELGIUM<br />

BELGIUM<br />

1% W/V KLEVA LTD GREECE<br />

LIORESAL TABLETS 10MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LIORESAL TABLETS 25MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

SWITZERLAND


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 611<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LIORESAL TABLETS 25MG NOVARTIS<br />

FARMACEUTICA S.A<br />

LIOTON ‘1000’ GEL 100000 IU/100G SANOFI WINTHROP<br />

S.P.A.<br />

LIPANTHYL 100MG CAPSULE 100MG LABORATOIRES<br />

FOURNIER SCA<br />

LIPANTHYL 200MG CAPSULE 200MG LABORATOIRES<br />

FOURNIER SA<br />

LIPANTHYL 300MG CAPSULE 300MG LABORATOIRES<br />

FOURNIER SCA<br />

LIPITOR COATED TABLETS 10MG WARNER LAMBERT<br />

EXPORT LIMITED<br />

LIPITOR COATED TABLETS 20MG WARNER LAMBERT<br />

EXPORT LTD<br />

LIPITOR COATED TABLETS 40MG WARNER LAMBERT<br />

EXPORT LIMITED<br />

LIPITOR TABLETS 10MG COATED TABLET 10MG WARNER LAMBERT<br />

EXPORT LTD T/A PARKE<br />

DAVIS RESEARCH LABS<br />

LIPITOR TABLETS 40MG COATED TABLET 40MG WARNER LAMBERT<br />

EXPORT LTD T/A PARKE<br />

DAVIS RESEARCH LABS<br />

SPAIN<br />

ITALY<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

LIPOBAY 0,4 FILM-COATED TABLET 0.4MG BAYER VITAL GMBH GERMANY<br />

LIPOBAY 0.1 FILM-COATED TABLET 0.1MG BAYER VITAL GMBH &<br />

CO. KG<br />

GERMANY<br />

LIPOBAY 0.2 FILM-COATED TABLET 0.2MG BAYER VITAL GMBH GERMANY<br />

LIPOBAY 0.3 FILM-COATED TABLET 0.3MG BAYER VITAL GMBH GERMANY<br />

LIPOFUNDIN MCT/LCT 10% EMULSION N/A B.BRAUN MELSUNGEN<br />

AG<br />

LIPOFUNDIN MCT/LCT 20% EMULSION N/A B.BRAUN MELSUNGEN<br />

AG<br />

LIPOFUNDIN N 10% EMULSION FOR<br />

INFUSION<br />

LIPOFUNDIN N 20% EMULSION FOR<br />

INFUSION<br />

100G/1000ML B.BRAUN MELSUNGEN<br />

AG<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

200G/1000ML B.BRAUN MELSUNGEN GERMANY<br />

LIPOFUNDIN S 10% EMULSION N/A B.BRAUN MELSUNGEN<br />

AG<br />

LIPOFUNDIN S 20% EMULSION N/A B.BRAUN MELSUNGEN<br />

AG<br />

LIPOGRASIL COATED TABLET N/A J.URIACH & CIA. S.A. SPAIN<br />

GERMANY<br />

GERMANY<br />

LIPO-MERZ RETARD CAPSULES 500MG MERZ+CO. GMBH & CO. GERMANY<br />

LIPOSTAT TABLETS 10MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

LIPOSTAT TABLETS 20MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

LIPOSTAT TABLETS 20MG BRISTOL-MYERS SQUIBB<br />

COMPANY<br />

LIPOSTAT (SELECTIN) TABLETS 10MG BRISTOL-MYERS SQUIBB<br />

S.P.A<br />

UNITED STATES OF<br />

AMERICA<br />

ITALY


EN<br />

612 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LIPOSTAT (SELECTIN) TABLETS 20MG BRISTOL-MYERS SQUIBB<br />

S.P.A<br />

LIPOSYN II 20% IV FAT EMULSION IV FAT EMULSION 20% ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

LIPOSYN II INTRAVENOUS FAT<br />

EMULSION<br />

INTRAVENOUS FAT<br />

EMULSION<br />

LIPOSYN III 10% INTRAVENOUS<br />

EMULSION<br />

ITALY<br />

N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

100MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

LIQUID PARAFFIN B.P. ORAL SOLUTION 100% V/V WILLIAM RANSOM &<br />

SON PLC<br />

UNITED KINGDOM<br />

LIQUID PARAFFIN BP ORAL LIQUID 100%V/V LCM LTD UNITED KINGDOM<br />

LIQUID PARAFFIN BP LIQUID 100% V/V PINEWOOD<br />

LABORATORIES LTD T/A<br />

PINEWOOD<br />

HEALTHCARE<br />

IRELAND<br />

LISKOMET TABLET TABLET 250MG LISKO PAKISTAN<br />

LISOCARD TABLETS 5MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

LISOCARD TABLETS 10MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

JORDAN<br />

JORDAN<br />

LISOPRIL TABLET 2.5MG DELTA HF ICELAND<br />

LISOPRIL TABLET 5MG DELTA HF ICELAND<br />

LISOPRIL TABLET 10MG DELTA HF ICELAND<br />

LISOPRIL TABLET 20MG DELTA HF ICELAND<br />

LISORIL-10 (LISINOPRIL TABLETS<br />

USP)<br />

LISORIL-5 (LISINOPRIL TABLETS<br />

USP)<br />

TABLET 10MG IPCA LABORATORIES<br />

LIMITED<br />

TABLET 5MG IPCA LABORATORIES<br />

LIMITED<br />

LISTERINE ANTISEPTIC LIQUID N/A WARNER-LAMBERT S.A.<br />

(PTY) LTD<br />

LITHIMOLE EYE DROPS SOLUTION 0.25% W/V COOPER S.A. GREECE<br />

LITHIMOLE EYE DROPS SOLUTION 0.5% W/V COOPER S.A. GREECE<br />

LITHONATE CR 400MG CONTROLLED RELEASE<br />

TABLET<br />

400MG APPROVED<br />

PRESCRIPTION SERVICES<br />

LTD<br />

LIVIAL TABLETS 2.5MG TABLET 2.5MG ORGANON<br />

LABORATORIES LIMITED<br />

INDIA<br />

INDIA<br />

SOUTH AFRICA<br />

LIVOSTIN NASAL SPRAY 0.5MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

LIVOSTIN EYE DROPS 0.5MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

LOBELIA TABLETS COATED TABLET N/A CATHAY OF<br />

BOURNEMOUTH LTD<br />

LOCABIOTAL 1% NASAL/BUCCAL INHAL.<br />

SOLN.<br />

1% W/V LABORATOIRES SERVIER FRANCE<br />

LOCACORTEN — VIOFORM EAR DROPS N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 613<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LOCACORTEN-VIOFORM CREAM N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LOCASALEN OINTMENT N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

SWITZERLAND<br />

LOCERYL CREAM CREAM 0.25%W/W GALDERMA (UK) LIMITED UNITED KINGDOM<br />

LOCERYL NAIL LACQUER 5% TOPICAL SOLUTION 5%W/V GALDERMA (UK) LIMITED UNITED KINGDOM<br />

LOCOID LIPOCREAM 1MG/G YAMANOUCHI PHARMA<br />

B.V.<br />

LOCOID OINTMENT 1MG/G YAMANOUCHI PHARMA<br />

B.V.<br />

LOCOID CREAM 1MG/G YAMANOUCHI PHARMA<br />

B.V.<br />

LOCOID C CREAM CREAM N/A YAMANOUCHI PHARMA<br />

LIMITED<br />

LOCOID CRELO 0.1% TOPICAL EMULSION 1MG/G YAMANOUCHI PHARMA<br />

B.V.<br />

LOCOID SCALP LOTION 1MG/ML YAMANOUCHI PHARMA<br />

B.V.<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

NETHERLANDS<br />

LOGYNON COATED TABLET N/A SCHERING AG GERMANY<br />

LOGYNON (SH B 264 AB) COATED TABLET N/A SCHERING HEALTH CARE<br />

LIMITED<br />

LOMAC -20 CAPSULES 20MG CIPLA INDIA<br />

LOMARIN TABLETS 50MG GEYMONAT SPA ITALY<br />

LOMARIN TABLETS 50MG GETMONAT SPA ITALY<br />

LOMEXIN VAGINAL CREAM 2G/100G RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

LOMEXIN DERMATOLOGICAL<br />

POWDER<br />

2G/100G RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

LOMEXIN VAGINAL SOLUTION 0.2G/100ML RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

LOMEXIN SOLUTION, SPRAY 2G/100G RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

LOMEXIN CREAM 2G/100G RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

LOMEXIN ‘T’ VAGINAL<br />

OVULE(CAPSULE)<br />

1000MG RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

LOMEXIN SOLUTION 2G/100ML RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

LOMEXIN VAGINAL<br />

OVULE(CAPSULE)<br />

200MG RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY


EN<br />

614 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LOMEX-T GASTRO RESISTANT<br />

TABLETS<br />

20MG OMEGA FARMA ICELAND<br />

LOMIR TABLETS 2.5MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LOMIR SRO CAPSULES 5MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

SWITZERLAND<br />

LOMOTIL TABLETS N/A MONSANTO PLC UNITED KINGDOM<br />

LOMOTIL TABLETS 2.5MG MONSANTO PLC T/A<br />

SEARLE<br />

UNITED KINGDOM<br />

LOMOTIL TABLETS N/A SEARLE PAKISTAN<br />

LOMOTIL TABLETS N/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED T/A<br />

GOLDSHIELD<br />

PHARMACEUT<br />

UNITED KINGDOM<br />

LONITEN TABLETS 10MG PHARMACIA LIMITED UNITED KINGDOM<br />

LONITEN 10MG TABLET 10MG PHARMACIA & UPJOHN<br />

INC.<br />

LOPAMID CAPSULE 2MG THE ACME<br />

LABORATORIES LTD.<br />

CANADA<br />

BANGLADESH<br />

LOPEDIUM CAPSULE 2MG HEXAL AG GERMANY<br />

LOPERAMIDE CAPSULES 2MG NORTON HEALTHCARE<br />

LIMITED<br />

LOPERAMIDE 2MG CAPSULES 2MG APPROVED<br />

PRESCRIPTION SERVICES<br />

LTD<br />

LOPERAMIDE COATED TABLETS<br />

2MG<br />

COATED TABLET 2MG LABORATORIO<br />

BENGUEREL LTDA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

LOPERAMIDE HYDROCHLORIDE TABLETS 2MG PHARMAMED LTD. GERMANY<br />

LOPERAMIDE HYDROCHLORIDE CAPSULES 2MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

LOPERAN CAPSULES 2MG CHIESI ESPANA S.A. SPAIN<br />

LOPERAN 2MG CAPSULE 2MG CHIESI WASSERMANN<br />

S.A.<br />

LOPID 600 FILMCOATED TABLET 600MG PARKE-DAVIS GMBH GERMANY<br />

LOPRESOR FILM COATED TABLETS 100MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

CHILE<br />

SPAIN<br />

SWITZERLAND<br />

LOPRESS 12.5 MG, TABLETS TABLETS 12.5 MG OMEGA FARMA EHF. ICELAND<br />

LOPRESS 50 MG, TABLETS TABLETS 50 MG OMEGA FARMA EHF. ICELAND<br />

LORANS 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS<br />

LORANS 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS<br />

LORAZEPAM TABLETS 1MG NORTON HEALTHCARE<br />

LIMITED<br />

LORAZEPAM TABLETS 2.5MG NORTON HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 615<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LORELIN DEPOT POWDER FOR INJECTION N/A DONG KOOK PHARM.<br />

CO. LTD<br />

KOREA REPUBLIC<br />

LORITIN TABLET 10MG DELTA HF ICELAND<br />

LOSEC GASTRO-RESISTANT<br />

CAPSULES<br />

10MG HASSLE LAKEMEDEL AB SWEDEN<br />

LOSEC CAPSULES 20MG ASTRA<br />

PHARMACEUTICALS<br />

LIMITED<br />

LOSEC MUPS GASTRO-RESISTANT<br />

TABLETS<br />

LOSEC MUPS GASTREO-RESISTANT<br />

TABLETS<br />

LOSEC MUPS GASTRO-RESISTANT<br />

TABLETS<br />

10MG HASSLE LAKEMEDEL AB SWEDEN<br />

20MG HASSLE LAKEMEDEL AB SWEDEN<br />

40MG HASSLE LAKEMEDEL AB SWEDEN<br />

LOTRIDERM CREAM N/A SCHERING-PLOUGH S.A. BELGIUM<br />

LUBEX LIQUID SKIN CLEANSING<br />

EMULSION<br />

UNITED KINGDOM<br />

30MG/G PERMAMED AG SWITZERLAND<br />

LUBEXYL SUSPENSION 40MG/G PERMAMED AG SWITZERLAND<br />

LUCRIN DEPOT POWDER FOR INJECTION 11.25MG/2ML ABBOTT AG SWITZERLAND<br />

LUCRIN DEPOT 3.75MG SOLUTION FOR<br />

INJECTION<br />

3.75MG/VIAL ABBOTT LABORATORIES<br />

S.A<br />

LUDIOMIL FILM COATED TABLETS 25MG NOVARTIS<br />

FARMACEUTICA S.A.<br />

LUDIOMIL FILM COATED TABLETS 10MG NOVARTIS<br />

FARMACEUTICA S.A.<br />

LUDIOMIL FILM COATED TABLETS 10MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

LUDIOMIL FILM COATED TABLETS 25MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SPAIN<br />

SPAIN<br />

SPAIN<br />

SWITZERLAND<br />

SWITZERLAND<br />

LUDIOMIL TABLET 10MG CIBA PAKISTAN<br />

LUDIOMIL TABLET 25MG CIBA PAKISTAN<br />

LUDIOMIL SOLUTION FOR<br />

INJECTION<br />

N/A NOVARTIS PHARMA<br />

GMBH<br />

AUSTRIA<br />

LUMAREN INJECTABLE SOLUTION 50MG/2ML ELPEN PHARM. CO. INC. GREECE<br />

LUMAREN COATED TABLET 150MG ELPEN PHARM. CO., INC. GREECE<br />

LUMIGAN OPHTALMIC SOLUTION 0.03% ALLERGAN INC UNITED STATES OF<br />

AMERICA<br />

LUSTRAL TABLET 100MG PFIZER LIMITED UNITED KINGDOM<br />

LUSTRAL TABLET 50MG PFIZER LIMITED UNITED KINGDOM<br />

LUSTYS GARLIC PERLES CAPSULE 0.66MG G R LANE HEALTH<br />

PRODUCTS LTD<br />

LUTENYL TABLET 5MG LABORATOIRES<br />

THERAMEX<br />

LUTRAX SOLUTION 0.15MG/ML ALCON LABORATORIOS,<br />

S.A. DE C.V.<br />

UNITED KINGDOM<br />

FRANCE<br />

MEXICO


EN<br />

616 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

LYCLEAR 1% W/W CREME RINSE CREAM 1% W/W GLAXO WELLCOME UK<br />

LIMITED<br />

LYOVAC COSMEGEN INJECTION<br />

0.5MG<br />

POWDER FOR INJECTION 0.5MG MERCK SHRP & DOHME<br />

B.V.<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

LYSPAFEN TABLET N/A JANSSEN-CILAG AG SWITZERLAND<br />

MAALOX SUSPENSION NA RORER<br />

PHARMACEUTICALS<br />

LIMITED<br />

MAALOX ‘PLUS’ TABLETS N/A RHONE POULENC RORER<br />

S.P.A.<br />

MAALOX NO.2 TABLET N/A RORER<br />

PHARMACEUTICALS LTD.<br />

(T/A RHONE POULENC<br />

RORER)<br />

MAALOX PLUS TABLET N/A RORER<br />

PHARMACEUTICALS LTD.<br />

(T/A RHONE POULENC<br />

RORER)<br />

MAALOX PLUS SUSPENSION N/A RORER<br />

PHARMACEUTICALS LTD.<br />

(T/A RHONE POULENC<br />

RORER)<br />

MAALOX PLUS TABLETS N/A RORER<br />

PHARMACEUTICALS<br />

MAALOX PLUS SUSPENSION NA RORER<br />

PHARMACEUTICALS<br />

LIMITED<br />

MAALOX TC (THERAPEUTIC<br />

CONCENTRATION)<br />

MAALOX TC (THERAPEUTIC<br />

CONCENTRATION)<br />

SUSPENSION N/A RORER<br />

PHARMACEUTICALS LTD.<br />

(T/A RHONE POULENC<br />

RORER)<br />

TABLET N/A RORER<br />

PHARMACEUTICALS LTD.<br />

(T/A RHONE POULENC<br />

RORER)<br />

IRELAND<br />

ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

MABRON 50MG CAPSULE 50MG MEDOCHEMIE LTD CYPRUS<br />

MABTHERA SOLUTION SOLUTION(VIALS) 100MG,500MG ROCHE<br />

PHARMA(SCHWEIZ) LTD.<br />

MACOREL CONTROLLED RELEASE<br />

CAPS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

20MG/CAP ELPEN PHARM. CO. INC. GREECE<br />

MACOX ZH JR TABLETS N/A MACLEODS<br />

PHARMACEUTICALS LTD<br />

MACOX-150 TABLET 150MG MACLEODS INDIA<br />

MACOX-150 CAPSULES 150MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

MACOX-300 TABLET 300MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

MACOX-300 CAPSULES 300MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

MACOX-450 CAPSULES 450MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

INDIA<br />

INDIA<br />

INDIA<br />

INDIA<br />

INDIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 617<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MACOX-ZH TABLETS N/A MACLEODS<br />

PHARMACEUTICALS LTD<br />

MACRODANTIN CAPSULES 50MG PROCTOER & GAMBLE<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

MACRODANTIN CAPSULES 100MG PROCTER & GAMBLE<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

MACROZIDE-500 TABLET 500MG MACLEODS INDIA<br />

MACROZIDE-750 TABLET 750MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

MADOPAR 250MG TABLET N/A ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

MAG. PHOS. 6X NEW ERA<br />

BIOCHEMIC NO.8<br />

MAGNESIA SAN PELLEGRINO<br />

(ANISE FLAVOUR)<br />

MAGNESIA SAN PELLEGRINO<br />

(LEMON FLAVOUR)<br />

TISSUE SALT TABLETS<br />

NO.8<br />

NA NEW ERA<br />

LABORATORIES LIMITED<br />

INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

INDIA<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

ORAL POWDER 900MG/G SAPROCHI SA SWITZERLAND<br />

ORAL POWDER 4.5G/10G SAPROCHI SA SWITZERLAND<br />

MAGNESIUM COMPLEXE CAPSULE N/A LABORATOIRE GOLAZ<br />

SA<br />

MAGNESIUM COMPLEXE<br />

CAPSULES<br />

MAGNESIUM SULPHATE BP SOLUTION FOR<br />

INJECTION<br />

CAPSULES NA LABORATOIRES GOLAZ<br />

SA<br />

SWITZERLAND<br />

SWITZERLAND<br />

N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

MAGNESIUM SULPHATE BP ORAL POWDER 100%W/W LCM LTD UNITED KINGDOM<br />

MAGNESIUM SULPHATE PASTE BP PASTE N/A LCM LTD UNITED KINGDOM<br />

MAGNESIUM SULPHATE PASTE BP PASTE N/A LCM LTD UNITED KINGDOM<br />

MAGNESIUM SULPHATE PASTE BP PASTE N/A LCM LTD UNITED KINGDOM<br />

MAGNESIUM TRISILICATE BP ORAL SUSPENSION N/A LCM LTD UNITED KINGDOM<br />

MAGNESIUM TRISILICATE CO. BP TABLETS N/A SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

MAGNEVIST SOLUTION FOR IV<br />

INJECTION<br />

UNITED KINGDOM<br />

469MG/ML SCHERING AG GERMANY<br />

MAGNEVIST SOLN. FOR IV INJECTION 469MG/ML SCHERING AG GERMANY<br />

MAGRILAN 20MG CAPSULE 20MG MEDOCHEMIE LTD CYPRUS<br />

MAGUROL 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS<br />

MANNITOL SOLUTION FOR<br />

INJECTION<br />

MANNITOL 20% IV INFUSION SOLUTION FOR<br />

INJECTION<br />

MANNITOL INTRAVENOUS<br />

INFUSION 15%W/V<br />

MANNITOL INTRAVENOUS<br />

INFUSON 10%W/V<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

10% W/V BP GALEN RESEARCH<br />

LABORATORIES LIMITED<br />

200G/1L BAXTER HEALTHCARE<br />

LIMITED<br />

150G/1000ML BAXTER HEALTHCARE<br />

LIMITED<br />

10%W/V BAXTER HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

618 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MANNITOL IV INFUSION<br />

POLYFUSOR M 20%BP<br />

SOLUTION FOR<br />

INJECTION<br />

MANNITOL/DEMO SOLUTION FOR IV<br />

INFUSION<br />

MANNS KNOBLAUCH PILLEN<br />

PLUS<br />

MANUSEPT ANTIBACTERIAL<br />

HAND RUB<br />

MARCAIN SOLUTION FOR<br />

INJECTION<br />

MARCAIN SOLUTION FOR<br />

INJECTION<br />

MARCAIN ADRENALIN SOLUTION FOR<br />

INJECTION<br />

MARCAIN ADRENALIN SOLUTION FOR<br />

INJECTION<br />

MARCAIN HEAVY SOLUTION FOR<br />

INJECTION<br />

MARCAIN HEAVY SOLUTION FOR<br />

INJECTION<br />

MARCAIN SPINAL SOLUTION FOR<br />

INJECTION<br />

20%BP FRESENIUS LIMITED UNITED KINGDOM<br />

200MG (20% W/V) DEMO SA GREECE<br />

COATED TABLET N/A DR. GERHARD MANN,<br />

CHEM.-PHARM. FABRIK<br />

GMBH<br />

GERMANY<br />

TOPICAL SOLUTION N/A SETON PRODUCTS LTD UNITED KINGDOM<br />

2.5MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

5MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

N/A ASTRA LAKEMEDEL AB SWEDEN<br />

N/A ASTRA LAKEMEDEL AB SWEDEN<br />

5MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

5MG/ML ASTRAZENECA SVERIGE<br />

AB<br />

SWEDEN<br />

5MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

MAREVAN TABLET 3 MG GOLDSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

MAREVAN TABLETS 1 MG GOLDSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

MAREVAN TABLETS 5 MG GOLDSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

MARVELON TABLETS 0.15MG AND<br />

0.03MG<br />

ORGANON<br />

LABORATORIES<br />

MARVELON 150/30 TABLETS TABLET N/A ORGANON<br />

LABORATORIES LIMITED<br />

MASTER-AID DISINFETTANTE CUTANEOUS SOLUTION 1G/100ML PIETRASANTA PHARMA<br />

S.R.L.<br />

MATERNA TAB TABLETS N/A WYETH-AYERST<br />

CANADA INC.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

CANADA<br />

MAXEPA CAPSULE N/A SEVEN SEAS LIMITED UNITED KINGDOM<br />

MAXIDEX OPHTHALMIC<br />

SUSPENSION<br />

1MG/ML S.A. ALCON-COUVREUR<br />

N.V.<br />

MAXIDEX OPHTHALMIC OINTMENT 1MG/G S.A. ALCON-COUVREUR<br />

N.V.<br />

MAXIMUM STRENGTH ANADIN<br />

ANALGESIC<br />

MAXIMUM STRENGTH ASPRO<br />

CLEAR<br />

TABLETS N/A WHITEHALL<br />

LABORATORIES LTD<br />

EFFERVESCENT TABLET 500MG ROCHE PRODUCTS<br />

LIMITED<br />

BELGIUM<br />

BELGIUM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 619<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MAXIPIME POWDER FOR INJECTION 1000MG/3ML BRISTOL MYERS SQUIBB<br />

S.P.A<br />

MAXIPIME POWDER FOR INJECTION 500MG/1.5ML BRISTOL MYERS SQUIBB<br />

S.P.A<br />

MAXIPIME INJECTION 2G POWDER FOR INJECTION 2G BRISTOL-MYERS SQUIBB<br />

PHARMACEUTICALS LTD<br />

MAXITROL OPHTHALMIC<br />

SUSPENSION<br />

N/A S.A. ALCON-COUVREUR<br />

N.V.<br />

MAXITROL OPHTHALMIC OINTMENT N/A S.A. ALCON-COUVREUR<br />

N.V.<br />

MAXIVALET SUGAR COATED<br />

TABLETS<br />

ITALY<br />

ITALY<br />

ITALY<br />

BELGIUM<br />

BELGIUM<br />

10MG DEMO ABEE GREECE<br />

MAXOLON TABLET 10MG SMITH KLINE BEECHAM PAKISTAN<br />

MAXOLON TABLET 10MG SMITH KLINE &<br />

BEECHAM<br />

MAXOLON INJECTION 5MG/ML SOLUTION FOR<br />

INJECTION<br />

0.5% W/V MONMOUTH<br />

PHARMACEUTICALS LTD<br />

MAXOLON PAEDIATRIC LIQUID ORAL SOLUTION 1MG/ML MONMOUTH<br />

PHARMACEUTICALS LTD<br />

MAXOLON TABLETS 10MG TABLET 10MG MONMOUTH<br />

PHARMACEUTICALS LTD<br />

PAKISTAN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MCP HEXAL 10 TABLET 10MG HEXAL AG GERMANY<br />

MCP-RATIOPHARM SOLUTION 5.2MG/ML RATIOPHARM GMBH GERMANY<br />

MCP-RATIOPHARM 10 SUPPOSITORY 10MG RATIOPHARM GMBH GERMANY<br />

MCP-RATIOPHARM 10<br />

TABLETTEN<br />

MDS NORDION S.A. TECHNETIUM<br />

(TC-99M) GEN<br />

MEASLES AND RUBELLA VIRUS<br />

VACCINE LIVE<br />

MEASLES MUMPS AND RUBELLA<br />

LIVE ATTENUATED<br />

MEASLES VACCINE LIVE<br />

ATTENUATED<br />

MEASLES, MUMPS AND RUBELLA<br />

VACCINE<br />

TABLET 10MG RATIOPHARM GMBH GERMANY<br />

INTRAVENOUS<br />

INJECTION<br />

NA BRISTOL=MYERS SQUIBB<br />

PHARMA BELGIUM S.A.<br />

POWDER FOR INJECTION N/A SERUM INSTITUTE OF<br />

INDIA LTD<br />

FREEZE DRIED CAKE F/<br />

INJ<br />

N/A M/S SERUM INSTITUTE<br />

OF INDIA LIMITED<br />

POWDER FOR INJECTION 1000 CCID50 SERUM INSTITUTE OF<br />

INDIA LTD<br />

POWDER FOR INJECTION N/A SERUM INSTITUTE OF<br />

INDIA LTD.<br />

BELGIUM<br />

MEBEVERINE TABLETS BP 135MG FILM COATED TABLETS 135MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

MECLON CREAM N/A FARMIGEA SPA ITALY<br />

MECLON VAGINAL PESSARY N/A FARMIGEA SPA ITALY<br />

MECLON ‘1000’ VAGINAL DOUCHE,<br />

SOLUTION<br />

INDIA<br />

INDIA<br />

INDIA<br />

INDIA<br />

N/A FARMIGEA SPA ITALY<br />

MECLON ‘1000’ VAGINAL CREAM N/A FARMIGEA SPA ITALY<br />

MEDAXONE 1G POWDER FOR INJECTION 1G MEDOCHEMIE LTD CYPRUS<br />

MEDAXONUM PWDR FOR INJ WITH<br />

SOLVENT<br />

1G MEDOCHEMIE LTD. CYPRUS


EN<br />

620 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MEDAXONUM 500MG POWDER FOR INJ<br />

+SOLVENT<br />

500MG/VIAL MEDOCHEMIE LTD CYPRUS<br />

MEDIANOX CAPSULE 500MG DR.GROSSMANN AG<br />

PHARMACA<br />

SWITZERLAND<br />

MEDIATOR 150MG COATED TABLET 150MG LABORATOIRES SERVIER FRANCE<br />

MEDICAID ANTISEPTIC CREAM CREAM 0.5%W/W EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

MEDIJEL GEL DENTAL GEL N/A D D D LIMITED UNITED KINGDOM<br />

MEDIJEL PASTILLES LOZENGE N/A D D D LIMITED UNITED KINGDOM<br />

MEDI-KEEL A THROAT LOZENGES LOZENGES N/A ADCOCK INGRAM LTD SOUTH AFRICA<br />

MEDI-KEEL A THROAT SPRAY THROAT SPRAY 0.5G/100ML THE PREMIER<br />

PHARMACEUTICAL<br />

COMPANY LTD.<br />

SOUTH AFRICA<br />

MEDINOL OVER 6 PARACETAMOL ORAL SUSPENSION 250 MG CUPAL LIMITED UNITED KINGDOM<br />

MEDINOL OVER 6 PARACETAMOL<br />

ORAL SUSPEN.<br />

MEDINOL UNDER 6<br />

PARACETAMOL<br />

MEDINOL UNDER 6<br />

PARACETAMOL ORAL SUSP BP<br />

ORAL SUSPENSION 250MG/5ML CUPAL LTD UNITED KINGDOM<br />

ORAL SUSPENSION 120 MG CUPAL LIMITED UNITED KINGDOM<br />

SUSPENSION 120MG/5ML CUPAL LTD. UNITED KINGDOM<br />

MEDOBETA OINTMENT 0.1%W/W MEDOCHEMIE LTD CYPRUS<br />

MEDOBETA CREAM 0.1G/100G MEDOCHEMIE LTD CYPRUS<br />

MEDOCIPRIN TABLETS 500MG MEDOCHEMIE LTD. CYPRUS<br />

MEDOCIPRIN TABLET 250MG MEDOCHEMIE LTD CYPRUS<br />

MEDOCLAZIDE 80MG TABLET 80MG MEDOCHEMIE LTD CYPRUS<br />

MEDOCLOR 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS<br />

MEDOCRIPTINE 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS<br />

MEDOCRIPTINE 2.5MG TABLET 2.5MG MEDOCHEMIE LTD CYPRUS<br />

MEDOCYCLINE 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS<br />

MEDODERMONE CREAM 0.05% W/W MEDOCHEMIE LTD CYPRUS<br />

MEDODERMONE OINTMENT 0.05% W/W MEDOCHEMIE LTD CYPRUS<br />

MEDOFED SYRUP N/A MEDOCHEMIE LTD CYPRUS<br />

MEDOFLUCON 150MG CAPSULE 150MG MEDOCHEMIE LTD CYPRUS<br />

MEDOFLUCON 50MG CAPSULE 50MG MEDOCHEMIE LTD CYPRUS<br />

MEDOFULVIN 125MG TABLET 125MG MEDOCHEMIE LTD CYPRUS<br />

MEDOFULVIN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS<br />

MEDOLAX TABLET 12MG MEDOCHEMIE LTD CYPRUS<br />

MEDOLEXIN POWDER FOR OR.<br />

SUSPENSION<br />

125MG/5ML MEDOCHEMIE LTD CYPRUS<br />

MEDOLEXIN 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 621<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MEDOLEXIN 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS<br />

MEDOLEXIN FORTE 250MG/5ML POWDER FOR OR.<br />

SUSPENSION<br />

250MG/5ML MEDOCHEMIE LTD CYPRUS<br />

MEDOLIN 2MG/5ML SYRUP 2MG/5ML MEDOCHEMIE LTD CYPRUS<br />

MEDOLIN 4MG TABLET 4MG MEDOCHEMIE LTD CYPRUS<br />

MEDOMYCIN CAPSULE 100MG MEDOCHEMIE LTD CYPRUS<br />

MEDONOL TABLET N/A MEDOCHEMIE LTD CYPRUS<br />

MEDOPEN 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS<br />

MEDOPHENICOL 1G POWDER FOR INJECTION 1G MEDOCHEMIE LTD CYPRUS<br />

MEDOPRAZOLE 20MG CAPSULE 20MG MEDOCHEMIE LTD CYPRUS<br />

MEDOPRED 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

MEDOSTATIN TABLETS 20MG MEDOCHEMIE LTD. CYPRUS<br />

MEDOVERINE 135MG FILM<br />

COATED TABLETS<br />

FILM COATED TABLETS 135MG MEDOCHEMIE LTD. —<br />

CYPRUS<br />

CYPRUS<br />

MEDOVIR 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS<br />

MEDOVIR 250MG POWDER FOR INJECTION 250MG MEDOCHEMIE LTD CYPRUS<br />

MEDOVIR 5% W/W CREAM 5% W/W MEDOCHEMIE LTD CYPRUS<br />

MEDOVIR 800MG TABLET 800MG MEDOCHEMIE LTD CYPRUS<br />

MEDOZINE 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS<br />

MEFEMIC CAPSULE CAPSULE 250MG CAMDEN INDUSTRIES (M)<br />

SDN. BHD<br />

MEFENAMIC ACID CAPSULES 250MG NORTON HEALTHCARE<br />

LIMITED<br />

MEFENAMIC ACID 500MG<br />

TABLETS<br />

MEFENAMIC ACID BP CAPSULES<br />

250MG<br />

COATED TABLET 500MG SANOFI WINTHROP<br />

LIMITED T/A STERWIN<br />

MEDICINES<br />

CAPSULES 250MG SANOFI WINTHROP T/A<br />

STERWIN MEDICINES<br />

MALAYSIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MEFINTER FILM COATED CAPLET 500MG PT INTERBAT INDONESIA<br />

MEFLIAM TABLET 250MG CIPLA LTD INDIA<br />

MEGAPRESS TABLET 5MG GENEPHARM S.A. GREECE<br />

MEGGEZONES LOZENGE N/A SCHERING-PLOUGH<br />

LIMITED<br />

MELIANE COATED TABLET N/A LABORATOIRES<br />

SCHERING<br />

MELLERIL FILM COATED TABLETS 10MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

MELLERIL FILM COATED TABLETS 25MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

UNITED KINGDOM<br />

FRANCE<br />

SWITZERLAND<br />

SWITZERLAND<br />

MELLERIL TABLET 10MG SANDOZ PAKISTAN<br />

MELLERIL TABLET 25MG SANDOZ PAKISTAN


EN<br />

622 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MELLERIL FILM-COATED TABLETS 25MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

MELLERIL FILM COATED TABLETS 100MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

MELLERIL COATED TABLETS 25MG NOVARTIS FARMA —<br />

PRODUTOS<br />

FARMACEUTICOS S.A<br />

MELLERIL COATED TABLETS 10MG NOVARTIS FARMA —<br />

PRODUTOS<br />

FARMACEUTICOS S.A<br />

SWITZERLAND<br />

SWITZERLAND<br />

PORTUGAL<br />

PORTUGAL<br />

MELLERIL 100MG TABLETS 100MG NOVARTIS PAKISTAN<br />

MELLERIL 10MG TABLET 10MG NOVARTIS PAKISTAN<br />

MELLERIL 25MG TABLET 25MG NOVARTIS PAKISTAN<br />

MELOX TABLETS 7.5MG MEDOCHEMIE LTD. CYPRUS<br />

MELOX TABLETS 15MG MEDOCHEMIE LTD. CYPRUS<br />

MELOX SUPPOSITORIES 15MG MEDOCHEMIE LTD. CYPRUS<br />

MELOX 15MG SUPPOSITORIES 15MG MEDOCHEMIE LTD CYPRUS<br />

MENCEVAX (ACWY) POWDER FOR INJECTION N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

MENCEVAX AC POWDER FOR INJECTION N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

MENINGITEC SUSPENSION FOR<br />

INJECTION<br />

MENINGITEC SUSPENSION FOR<br />

INJECTION<br />

25MCG/0.5ML JOHN WYETH &<br />

BROTHER LTD<br />

25MCG JOHN WYETH &<br />

BROTHER LIMITED T/A<br />

WYETH VACCINES<br />

MENJUGATE POWDER FOR INJECTION N/A CHIRON S.P.A ITALY<br />

MENOMUNE — A/C/Y/W-135 FREEZE-DRIED<br />

PREPARATION<br />

BELGIUM<br />

BELGIUM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

N/A AVENTIS PASTEUR, INC. UNITED STATES OF<br />

AMERICA<br />

MENOMUNE-A/C/Y/W-135 COMBINED VACCINE N/A AVENTIS PASTEUR UNITED STATES OF<br />

AMERICA<br />

MENOPHASE TABLET N/A MONSANTO PLC T/A<br />

SEARLE<br />

MENTHODEX COUGH MIXTURE ORAL SOLUTION N/A BELL SONS & CO<br />

(DRUGGISTS) LIMITED<br />

MENTHOLATUM ANTISEPTIC<br />

LOZENGE<br />

MENTHOLATUM<br />

BALM/MENTHOLATUM VAPOUR<br />

RUB<br />

LOZENGE N/A THE MENTHOLATUM<br />

COMPANY LIMITED<br />

OINTMENT N/A THE MENTHOLATUM<br />

COMPANY LIMITED<br />

MENTHOLATUM DEEP HEAT RUB CREAM N/A THE MENTHOLATUM<br />

COMPANY LIMITED<br />

MENTHOLATUM NASAL INHALER INHALATION SOLUTION N/A THE MENTHOLATUM<br />

COMPANY LIMITED<br />

MENTHOLATUM/SUPERDRUG<br />

HEAT SPRAY<br />

TOPICAL SPRAY N/A THE MENTHOLATUM<br />

COMPANY LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 623<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MENZZA CREAM N/A HOE PHARMACEUTICALS<br />

SDN BHD<br />

MALAYSIA<br />

MEPHAMYCIN LACTAB 250MG MEPHA PHARMA AG SWITZERLAND<br />

MEPHAMYCIN LACTAB 500MG MEPHA PHARMA AG SWITZERLAND<br />

MEPHAMYCIN SUSPENSION 200MG/5ML MEPHA PHARMA AG SWITZERLAND<br />

MEPHAQUIN LACTAB 250MG MEPHA PHARMA AG SWITZERLAND<br />

MEPIVASTESIN INJECTION SOLUTION 30MG/ML ESPE DENTAL AG GERMANY<br />

MERCILON TABLETS 150UG AND 20UG ORGANON<br />

LABORATORIES<br />

MERCILON TABLETS TABLET N/A ORGANON<br />

LABORATORIES LIMITED<br />

MERESA 200 TABLET 200MG DOLORGIET GMBH & CO.<br />

KG<br />

MERESA 50 CAPSULE 50MG DOLORGIET GMBH & CO.<br />

KG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

MEROCAINE LOZENGES N/A MARION MERRELL LTD UNITED KINGDOM<br />

MEROCETS LOZENGES LOZENGE 1.4MG SETON PRODUCTS<br />

LIMITED<br />

UNITED KINGDOM<br />

MERONEM POWDER FOR INJECTION 500MG ZENECA LIMITED UNITED KINGDOM<br />

MERONEM POWDER FOR INJECTION 1G ZENECA LIMITED UNITED KINGDOM<br />

MERONEM POWDER FOR INJECTION 250MG/VIAL ZENECA LIMITED UNITED KINGDOM<br />

MERONEM POWDER FOR IM<br />

INJECTION<br />

500MG ZENECA LIMITED UNITED KINGDOM<br />

MERONEM POWDER FOR INJECTION 1G ZENECA LIMITED UNITED KINGDOM<br />

MERONEM POWDER FOR IV<br />

INJECTION<br />

MESAGIN ENTERIC COATED<br />

TABLETS<br />

500MG ZENECA LIMITED UNITED KINGDOM<br />

400MG KLEVA LTD GREECE<br />

MESONEX TABLET 50MG ADELCO SA GREECE<br />

MESONEX TABLETS 100MG ADELCO<br />

CHROMATOURGIA<br />

ATHINON E.<br />

COLOCOTRONIS BROS<br />

S.A.<br />

GREECE<br />

MESTINON TABLET 60MG ROCHE PAKISTAN<br />

MESTINON TABLETS 60MG TABLET 60MG ICN PHARMACEUTICALS<br />

LIMITED<br />

MESTINON TABLETS 60MG TABLET 60MG ICN PHARMACEUTICALS<br />

LIMITED<br />

METADOXIL TABLET 500MG LFD MANUFACTURING<br />

LIMITED<br />

META-IODOBENZYLGUANIDINE<br />

(131-I)<br />

META-IODOBENZYLGUANIDINE<br />

(131-I) FOR DIAGNOSTIC USE<br />

SOLUTION FOR<br />

INJECTIONS<br />

SOLUTION FOR<br />

INJECTIONS<br />

N/A NYCOMED AMERSHAM<br />

PLC<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

THAILAND<br />

UNITED KINGDOM<br />

18.5MB/ML AMERSHAM PLC UNITED KINGDOM


EN<br />

624 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

METALYSE POW AND SOLVENT F/ S.<br />

F/INJ<br />

METALYSE POW AND SOLV F/SOL F/<br />

INJ<br />

8,000 U BOEHRINGER INGELHEIM<br />

INTERNATIONAL GMBH<br />

10,000 U BOEHRINGER INGELHEIM<br />

INTERNATIONAL GMBH<br />

GERMANY<br />

GERMANY<br />

METFORMIN — BMS TABLETS 500MG GEA LTD DENMARK<br />

METFORMIN DENK 850 FILM COATED TABLETS 850MG E.DENK OHG GERMANY<br />

METFORMIN TABLET TABLET 500MG CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

METFORMIN TABLETS BP TABLETS 500MG INTAS<br />

PHARMACEUTICALS LTD.<br />

METHADONE MIXTURE 1MG/1ML<br />

DTF<br />

METHADONE MIXTURE DTF 1MG<br />

IN 1ML<br />

METHADONE ORAL SOLN.<br />

1MG/1ML SUGAR FREE<br />

METHOTREXATE INJECTION<br />

25MG/ML<br />

METHOTREXATE INJECTION<br />

5MG/2ML<br />

METHOTREXATE INJECTION BP<br />

VIAL<br />

ORAL SOLUTION 1MG/1ML MACARTHYS<br />

LABORATORIES LIMITED<br />

ORAL SOLUTION 0.1%W/V MARTINDALE<br />

PHARMACEUTICALS LTD<br />

ORAL SOLUTION 1MG/ML ROSEMONT<br />

PHARMACEUTICALS LTD<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

METHOTREXATE INJECTION VIAL SOLUTION FOR<br />

INJECTION<br />

METHOTREXATE SODIUM<br />

TABLETS<br />

METHOTREXATUM PHARMACIA SOLUTION FOR<br />

INJECTION<br />

METHYL SALICYLATE OINTMENT<br />

BP<br />

25MG/ML FAULDING<br />

PHARMACEUTICALS PLC<br />

5MG/2ML FAULDING<br />

PHARMACEUTICALS PLC<br />

50MG/2ML PHARMACIA (PERTH)<br />

PTY. LTD.<br />

5MG/2ML F.H. FAULDING & CO.<br />

LTD (T/A DAVID BULL<br />

LABS)<br />

TABLETS 2.5MG WYETH-AYERST<br />

LABORATORIES<br />

MALAYSIA<br />

INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

AUSTRALIA<br />

25MG/1ML PHARMACIA NV/SA BELGIUM<br />

UNITED STATES OF<br />

AMERICA<br />

OINTMENT 50%W/W THORNTON & ROSS LTD UNITED KINGDOM<br />

METHYLDOPA BP 125MG TABLET 125MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

METHYLDOPA BP 250MG TABLET 250MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

METHYLDOPA BP 500MG TABLET 500MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

METHYLDOPA TABLETS FILM COATED TABLET 250MG CP PHARMACEUTICALS<br />

LIMITED<br />

METHYLDOPA TABLETS BP<br />

125MG<br />

METHYLDOPA TABLETS BP<br />

125MG<br />

METHYLDOPA TABLETS BP<br />

250MG<br />

TABLETS 125MG CP PHARMACEUTICALS<br />

LTD.<br />

FILM COATED TABLET 125MG CP PHARMACEUTICALS<br />

LTD<br />

TABLETS 250MG CP PHARMACEUTICALS<br />

LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 625<br />

Trade Name Dosage Form Dose MA Holder Country<br />

METHYLDOPA TABLETS BP<br />

500MG<br />

METHYLDOPA TABLETS BP<br />

500MG<br />

METHYLENE BLUE INJECTION USP<br />

1%<br />

METHYLENE BLUE INJECTION USP<br />

1% 5ML<br />

TABLETS 500MG CP PHARMACEUTICALS<br />

LTD.<br />

FILM COATED TABLET 500MG CP PHARMACEUTICALS<br />

LTD<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

1%W/V MARTINDALE<br />

PHARMACEUTICALS LTD<br />

1% W/V FAULDING<br />

PHARMACEUTICALS PLC<br />

METHYLPREDNISOLONE INJ. VIAL POWDER FOR INJECTION 1G/VIAL F.H. FAULDING & CO.<br />

LTD. (T/A DAVID BULL<br />

LABS)<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

METHYLPREDNISOLONE MERCK POWDER FOR INJECTION 40MG MERCK GENERICS FRANCE<br />

METHYLPREDNISOLONE SODIUM<br />

SUCCINATE<br />

METOCLOPRAMIDE INJECTION SOLUTION FOR<br />

INJECTION<br />

METOCLOPRAMIDE INJECTION BP<br />

10MG/2ML<br />

METOCLOPRAMIDE INJECTION<br />

USP<br />

POWDER FOR INJECTION 500MG FAULDING<br />

PHARMACEUTICALS PLC<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

10MG/2ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

10MG/2ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

10MG/2ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

METOLAR TABLETS 50MG CIPLA LIMITED INDIA<br />

METOLAR 100 TABLETS 100MG CIPLA LIMITED INDIA<br />

METOMIDE TABLET 10MG CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

METOPROLOL TARTARATE<br />

TABLETS 100MG<br />

MALAYSIA<br />

TABLET 100MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

METOSYN CREAM 0.05% W/V ZENECA LIMITED UNITED KINGDOM<br />

METOSYN FAPG CREAM CREAM 0.05% W / W BIOGLAN<br />

LABORATORIES LTD<br />

METOSYN OINTMENT OINTMENT 0.05% W / W BIOGLAN<br />

LABORARORIES LTD<br />

METRODIN HP 150IU POWDER FOR INJECTION 150IU HFSH/ML LABORATOIRES SERONO<br />

SA<br />

METRODIN HP 75IU INJECTABLE<br />

PREPARATION<br />

75IU HFSH/ML LABORATOIRES SERONO<br />

SA<br />

METROGYL INJECTABLE SOLUTION 500MG/100ML COOPER S.A. GREECE<br />

METROGYL 200 TABLET 200MG ALPHAPHARM PTY<br />

LIMITED<br />

METROGYL 400 TABLET 400MG ALPHAPHARM PTY<br />

LIMITED<br />

METROGYL INJECTION SOLUTION FOR<br />

INJECTION<br />

5MG/ML UNIQUE<br />

PHARMACEUTICAL<br />

LABORATORIES<br />

METROLYL SUPPOSITORIES 500MG LAGAP<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

AUSTRALIA<br />

AUSTRALIA<br />

INDIA<br />

UNITED KINGDOM


EN<br />

626 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

METROLYL SUPPOSITORY 1G LAGAP<br />

PHARMACEUTICALS<br />

LIMITED<br />

METRONIDAZOLE TABLETS 200MG NORTON HEALTHCARE<br />

LIMITED<br />

METRONIDAZOLE TABLETS 400MG NORTON HEALTHCARE<br />

LIMITED<br />

METRONIDAZOLE TABLET 200MG CAMDEN INDUSTRIES(M)<br />

SDN.BHD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

METRONIDAZOLE TABLETS 200MG PHARMAMED LTD. MALTA<br />

METRONIDAZOLE SOLUTION FOR<br />

INJECTION<br />

500MG/100ML PHARMAMED<br />

PARENTERALS LTD.<br />

METRONIDAZOLE TABLET 200MG CIPLA LTD INDIA<br />

METRONIDAZOLE INJECTION<br />

500MG/100ML<br />

METRONIDAZOLE INJECTION, USP<br />

500MG<br />

METRONIDAZOLE INTRAVENOUS<br />

INFUSION BP<br />

IV INFUSION SOLUTION 500MG/100ML B.BRAUN MELSUNGEN<br />

AG<br />

SOLUTION FOR<br />

INJECTION<br />

METRONIDAZOLE MERCK SOLUTION F/INF. IN A<br />

VIAL<br />

METRONIDAZOLE TABLETS BP<br />

TRICHOGYL-200<br />

MALTA<br />

GERMANY<br />

5MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

INTRAVENOUS INFUSION 5MG/ML VYSALI<br />

PHARMACEUTICALS<br />

LIMITED<br />

INDIA<br />

0.5G/100ML MERCK GENERIQUES FRANCE<br />

TABLET 200MG TABLETS (INDIA) LIMITED INDIA<br />

METROTOP GEL 0.8% W/V SETON PRODUCTS LTD UNITED KINGDOM<br />

METVIX CREAM 160MG/G GALDERMA (UK) LIMITED UNITED KINGDOM<br />

MEXETIL CAPSULES 200MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

MIACALCIC NASAL SPRAY 200IU NOVARTIS<br />

FARMACEUTICA S.A<br />

MIACALCIC NASAL SPRAY 200IU NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

MIACALCIC SOLUTION FOR<br />

INJECTION<br />

100IU/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

MIANSERIN TABLETS 10MG NORTON HEALTHCARE<br />

LIMITED<br />

MIANSERIN 20MG TABLETS NORTON HEALTHCARE<br />

LIMITED<br />

MIANSERIN TABLETS 30MG NORTON HEALTHCARE<br />

LIMITED<br />

GERMANY<br />

SPAIN<br />

SWITZERLAND<br />

SWITZERLAND<br />

MIANSERIN TABLETS 10MG REMEDICA LTD. CYPRUS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MIANSERIN TABLETS BP 10MG TABLET 10MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

MIANSERIN TABLETS BP 30MG COATED TABLETS 30MG GENERICS (UK) LTD. UNITED KINGDOM<br />

MIBG-131-D SOLUTION FOR<br />

INJECTION<br />

MIBG-131-T SOLUTION FOR<br />

INJECTION<br />

N/A CIS BIO INTERNATIONAL FRANCE<br />

N/A CIS BIO INTERNATIONAL FRANCE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 627<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MICANOL CREAM 1% CREAM 1% W / W BIOGLAN<br />

LABORATORIES<br />

MICANOL CREAM 3% CREAM 3% W / W BIOGLAN<br />

LABORATORIES LTD<br />

MICARDIS TABLET 40MG BOEHRINGER INGELHEIM<br />

INTERNATIONAL GMBH<br />

MICARDIS TABLETS 80MG BOEHRINGER INGELHEIN<br />

INTERNATIONAL GMBH<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

MICARDIS PLUS TABLETS NA BOEHRINGER INGELHEIM EUROPEAN COMMUNITY<br />

MICOGEL CREAM 2%W/W CIPLA LIMITED INDIA<br />

MICONAL ECOBI CREAM 2% W/W FARMACEUTICI ECOBI<br />

S.A.S<br />

MICONAL ECOBI POWDER (TOPICAL) 2% W/W FARMACEUTICI ECOBI<br />

SAS<br />

MICONAL ECOBI VAGINAL CREAM 2% W/W FARMACEUTICI ECOBI<br />

S.A.S<br />

MICONAL ECOBI VAGINAL OVULES 50MG FARMACEUTICI ECOBI<br />

S.A.S<br />

MICONAL ECOBI VAGINAL SOLUTION N/A FARMACEUTICI ECOBI<br />

S.A.S<br />

MICONAL ECOBI VAGINAL CAPSULES 1200MG FARMACEUTICI ECOBI<br />

S.A.S<br />

MICROCIDAL — 125 TABLET 125MG PHARMACARE LIMITED SOUTH AFRICA<br />

MICROENEMA RECTAL ENEMA NA ATCO LABORATORIES<br />

(PVT) LTD<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

PAKISTAN<br />

MICROGYNON COATED TABLET N/A SCHERING AG GERMANY<br />

MICROGYNON COATED TABLET N/A SCHERING HEALTH CARE<br />

LIMITED<br />

MICROLAX ENEMA, RECTAL<br />

SOLUTION<br />

MICTRAL SACHETS GRANULES FOR ORAL<br />

SOLN.<br />

MIDAZOLAM 2MG/ML INJECTION SOLUTION FOR<br />

INJECTION<br />

MIDAZOLAM INJECTION BP SOLUTION FOR<br />

INJECTION<br />

MIDAZOLAM INJECTION BP<br />

1MG/ML<br />

MIDAZOLAM INJECTION BP<br />

5MG/ML<br />

MIDAZOLAM INJECTION BP<br />

5MG/ML<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

MIFLONIDE POWDER IN CAPSULES<br />

FOR INHALATION<br />

MIFLONIDE POWDER IN CAPSULES<br />

FOR INHALATION<br />

N/A PHARMACIA SVERIGE AB SWEDEN<br />

N/A SANOFI WINTHROP<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

2MG/ML PHOENIX PHARMA LTD UNITED KINGDOM<br />

5MG/ML CP PHARMACEUTICALS<br />

LIMITED<br />

1MG/ML RANBAXY<br />

LABORATORIES LTD<br />

5MG/ML RANBAXY<br />

LABORATORIES LTD.<br />

5MG/ML CP PHARMACEUTICALS<br />

LTD<br />

200MCG NOVARTIS<br />

FARMACEUTICA S.A<br />

400MCG NOVARTIS<br />

FARMACEUTICA S.A<br />

UNITED KINGDOM<br />

INDIA<br />

INDIA<br />

UNITED KINGDOM<br />

SPAIN<br />

SPAIN


EN<br />

628 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MIFLONIDE 200 POWDER FOR<br />

INHALATION<br />

MIFLONIDE 400 POWDER FOR<br />

INHALTION<br />

200MG NOVARTIS PHARMA<br />

SCHWEIZ AG —<br />

SWITZERLAND<br />

400MG NOVARTIS PHARMA<br />

SCHWEIZ AG-<br />

SWITZERLAND<br />

MIGRALEVE COATED TABLET N/A UNICLIFFE LIMITED T/A<br />

PFIZER CONSUMER<br />

HEALTHCARE<br />

MIGRALEVE YELLOW COATED TABLET N/A UNICLIFFE LIMITED T/A<br />

PFIZER CONSUMER<br />

HEALTHCARE<br />

MIGRALGINE ORAL SOLUTION N/A LABORATOIRES MARTIN-<br />

JOHNSON & JOHNSON-<br />

MSD<br />

MIGRALGINE CAPSULES N/A LABORATOIRES JEAN-<br />

PAUL MARTIN<br />

MIGRANERTON CAPSULE N/A DOLORGIET GMBH & CO.<br />

KG<br />

MIGRIL TABLETS N/A THE WELLCOME<br />

FOUNDATION LTD.<br />

SWITZERLAND<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

GERMANY<br />

UNITED KINGDOM<br />

MIGRIL TABLETS N/A GLAXO WELLCOME PAKISTAN<br />

MILITHIN HARD CAPSULES 300MG MINERVA<br />

PHARMACEUTICAL S.A.<br />

MILTEX SOLUTION FOR TOPICAL<br />

USE<br />

GREECE<br />

600MG/10ML ASTA MEDICA AG GERMANY<br />

MINADEX TONIC ORAL EMULSION N/A SEVEN SEAS LIMITED UNITED KINGDOM<br />

MINESSE TABLETS NA JOHN WYETH &<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

MINIDIAB TABLETS 5MG PHARMACIA & UPJOHN<br />

S.P.A.<br />

MINIHEP SYRINGE N/A LEO LABORATORIES<br />

LIMITED<br />

MINIHEP SOLUTION FOR<br />

INJECTION<br />

25,000IU/ML LEO PHARMACETICAL<br />

PRODUCTS<br />

MINIMS ATROPINE SULPHATE 1% EYE DROPS 1%W/V CHAUVIN<br />

PHARMACEUTICALS<br />

LIMITED<br />

MINIMS BENOXINATE<br />

HYDROCHLORIDE 0.4% W/V<br />

MINIMS CYCLOPENTOLATE<br />

HYDROCHLORIDE<br />

EYE DROPS 0.4% W/V CHAUVIN<br />

PHARMACEUTICALS LTD.<br />

EYE DROPS 1% W/V CHAUVIN<br />

PHARMACEUTICALS LTD.<br />

MINIMS FLUORESCEI SODIUM EYE DROPS 1% CHAUVIN<br />

PHARMACEUTICALS<br />

LIMITED<br />

MINIMS METIPRANOLOL 0.3%<br />

W/V<br />

MINIMS PHENYLEPHRINE<br />

HYDROCHLORIDE<br />

EYE DROPS 0.3% W/V CHAUVIN<br />

PHARMACEUTICALS<br />

LIMITED<br />

EYE DROPS 10% W/V CHAUVIN<br />

PHARMACEUTICALS LTD.<br />

IRELAND<br />

ITALY<br />

UNITED KINGDOM<br />

DENMARK<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 629<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MINIMS PHENYLEPHRINE<br />

HYDROCHLORIDE SOL.<br />

MINIMS PILOCARPINE NITRATE<br />

2.0% W/V<br />

EYE DROPS 2.5% W/V CHAUVIN<br />

PHARMACEUTICALS LTD.<br />

EYE DROPS 2% W/V CHAUVIN<br />

PHARMACEUTICALS<br />

LIMITED<br />

MINIMS TROPICAMIDE 0.5% W/V EYE DROPS 0.5% W/V CHAUVIN<br />

PHARMACEUTICALS LTD.<br />

MINIMS TROPICAMIDE 1% W/V EYE DROPS 1% W/V CHAUVIN<br />

PHARMACEUTICALS LTD.<br />

MINIRIN NASAL SPRAY 10MCG/DOSE FERRING AB SWEDEN<br />

MINIRIN NASAL DROPS 0.1MG/ML FERRING AB SWEDEN<br />

MINIRIN TABLETS 0.2MG FERRING AB SWEDEN<br />

MINIRIN TABLETS 0.1MG FERRING AB SWEDEN<br />

MINIRIN NASAL DROPS 0.1MG/ML FERRING AB SWEDEN<br />

MINIRIN NASAL SPRAY 10MICROGRAMS/<br />

DO<br />

FERRING AB SWEDEN<br />

MINITRAN 10 TRANSDERMAL PATCH 10MG/24HOUR 3M HEALTH CARE<br />

LIMITED<br />

MINITRAN 5, TRANSDERMAL PATCH 5MG/24HRS 3M HEALTH CARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MINOCIN CAPSULES 100MG LEDERLE LABORATORIES UNITED STATES OF<br />

AMERICA<br />

MINOCIN CAPSULES 50MG LEDERLE LABORATORIES UNITED STATES OF<br />

AMERICA<br />

MINOCYCLINE 100MG CAPSULES 100MG AEGIS LTD. CYPRUS<br />

MINOCYCLINE 50MG CAPSULES 50MG AEGIS LTD. CYPRUS<br />

MINOXIDIL TABLETS 10MG DANBURY PHARMACAL<br />

INC.<br />

MINSK TABLET 10MG ANFARM HELLAS S.A. GREECE<br />

UNITED STATES OF<br />

AMERICA<br />

MINULET COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY<br />

MINULET TABLETS NA JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

MINULET TABLETS COATED TABLET N/A JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

—UK<br />

MIOCAMEN GRANULES FOR<br />

SUSPENSION<br />

20% W/W A.MENARINI INDUSTRIE<br />

FARMACEUTICHE<br />

RIUNITE S.R.L.<br />

MIOCAMEN 600MG TABLET 600MG A.MENARINI INDUSTRIE<br />

FARMACEUTICHE<br />

RIUNITE S.R.L.<br />

MIOCHOL-E INTRAOCULAR<br />

SOLUTION<br />

MIOCHOL-E 1:100 WITH<br />

ELECTROLYTE DILUENT<br />

INTRAOCULAR<br />

SOLUTION<br />

10MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

N/A CIBA VISION<br />

CORPORATION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

SWITZERLAND<br />

UNITED STATES OF<br />

AMERICA


EN<br />

630 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MIOREL TABLETS 10MG KLEVA LIMITED GREECE<br />

MIOSTAT INTRAOCULAR<br />

SOLUTION<br />

MIOSTAT INTRAOCULAR<br />

SOLUTION<br />

MIOVISIN POWDER AND<br />

SOLUTION FOR INJ<br />

0.01% W/V ALCON LABORATORIES<br />

INC.<br />

0.10 MG S.A ALCON COUVREUR<br />

N.V<br />

UNITED STATES OF<br />

AMERICA<br />

BELGIUM<br />

20MG FARMIGEA SPA ITALY<br />

MIRENA 20 MICROG/24H INTRAUTERINE SYSTEM 52MG LEIRAS OY FINLAND<br />

MISODOMIN TABLETS 40MG KLEVA LIMITED GREECE<br />

MITOCIN POWDER FOR INJECTION 2MG KOREA UNITED PHARM.<br />

INC.<br />

MITOCIN POWDER FOR INJECTION 10MG KOREA UNITED PHARM.<br />

INC.<br />

MITOMYCIN POWDER FOR INJECTION 10MG/VIAL FAULDING<br />

PHARMACEUTICALS PLC.,<br />

T/A DAVID BULL<br />

LABORATORIES<br />

MIVACRON INJECTION SOLUTION FOR<br />

INJECTION<br />

MIVACRON INJECTION 2MG/ML SOLUTION FOR<br />

INJECTION<br />

MIXTARD 30 HM 100IU/ML 10 ML<br />

VIAL<br />

MIXTARD 30 HM PENFILL<br />

100IU/ML 1.5ML<br />

SUPENSION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

2MG/ML THE WELLCOME<br />

FOUNDATION LIMITED<br />

2MG/ML THE WELLCOME<br />

FOUNDATION LIMITED<br />

KOREA REPUBLIC<br />

KOREA REPUBLIC<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NA NOVO NORDISK DENMARK<br />

NA NOVO NORDISK A/S DENMARK<br />

MIZOLLEN S.R. 10MG SR COATED TABLET 10MG LABORATOIRES<br />

SYNTHELABO<br />

FRANCE<br />

MMR-II-VAX VACCINE N/A MERCK SHARP & DOHME NETHERLANDS<br />

MOBIC SUPPOSITORIES 7.5MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

MOBIC SOLUTION FOR<br />

INJECTION<br />

15MG/1.5ML BOEHRINGER INGELHEIM<br />

INTERNATIONAL GMBH<br />

MOBIC 15MG TABLETS 15MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

MOBILAT CREAM N/A SANKYO PHARMA GMBH GERMANY<br />

MOBILAT GEL N/A SANKYO PHARMA GMBH GERMANY<br />

MOBILIS 20 CAPSULE 20MG ALPHAPHARM PTY<br />

LIMITED<br />

MOBILIS D-20 DISPERSIBLE TABLET 20MG ALPHAPHARM PTY<br />

LIMITED<br />

AUSTRALIA<br />

AUSTRALIA<br />

MOBILISIN CREAM N/A SANKYO PHARMA GMBH GERMANY<br />

MODECATE SOLUTION FOR IM<br />

INJECTION<br />

25MG/ML BRISTOL MYERS SQUIBB<br />

S.P.A.<br />

MODITEN TABLETS 1MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

MODOPAR 125 CAPSULE N/A F. HOFFMANN-LA ROCHE<br />

LTD.<br />

ITALY<br />

FRANCE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 631<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MODOPAR 250 CAPSULE N/A F. HOFFMANN-LA ROCHE<br />

LTD.<br />

MODOPAR 62.5 CAPSULE N/A F. HOFFMANN-LA ROCHE<br />

LTD.<br />

MODOPAR LP 125 PROLONGED RELEASE<br />

CAPSULE<br />

N/A F. HOFFMANN-LA ROCHE<br />

LTD.<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

MODURETIC TABLET N/A MERCK SHARP & DOHME PAKISTAN<br />

MODURETIC TABLET N/A M.S.D. PAKISTAN<br />

MODURETIC 5/50MG TABLET N/A MERCK SHARP & DOHME<br />

B.V.<br />

MOGADON TABLETS 5MG TABLETS 5MG ICN PHARMACEUTICALS<br />

LTD<br />

NETHERLANDS<br />

UNITED KINGDOM<br />

MOISTUR-EYES ‘DRY EYE’ DROPS EYE DROPS 0.3% W/V CO-PHARMA LIMITED UNITED KINGDOM<br />

MOLCER EAR DROPS 5%W/V WALLACE<br />

MANUFACTURING<br />

CHEMISTS LIMITED<br />

MOMENDOL COMPRESSA RIVESTITA 220MG AZ.CHIM. RIUN<br />

ANGELINI FRANCESCO<br />

ACRAF S.P.A<br />

MOMENDOL, GEL GEL NA AZ. CHIM. RIUN.<br />

ANGELINI FRANCESCO<br />

ACRAF SPA — ITALY<br />

MOMENT 200, BLISTER 12 COMPRESSA RIVESTITA 200MG AZ. CHIM. RIUN.<br />

ANGELINI FRANCESCO<br />

ACRAF SPA — ITALY<br />

MOMENT 200, BLISTER 24 COMPRESSA RIVESTITA 200MG AZ. CHIM. RIUN.<br />

ANGELINI FRANCESCO<br />

ACRAF SPA — ITALY<br />

MOMENT 200, GOCCE ORALI GOCCE ORALI NA AZ. CHIM. RIUN.<br />

ANGELINI FRANCESCO<br />

ACRAF SPA-ITALY<br />

UNITED KINGDOM<br />

MONO MACK 20MG TABLETS 20MG HEINRICH MACK NACHF GERMANY<br />

MONO MACK 40MG TABLETS 40MG HEINRICH MACK NACHF GERMANY<br />

MONO MACK DEPOT TABLETS W/SUST.<br />

ACTION<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

100MG HEINRICH MACK NACHF GERMANY<br />

MONOCLOX 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS<br />

MONOLONG CAPSULES 60MG CTS CHEMICAL<br />

INDUSTRIES LTD.<br />

MONOLONG 60MG CAPSULES CAPSULES 60MG CTS CHEMICAL<br />

INDUSTRIES LTD<br />

MONOPARIN SOLUTION FOR<br />

INJECTION<br />

MONOPARIN SOLUTION FOR<br />

INJECTION<br />

MONOPARIN SOLUTION FOR<br />

INJECTION<br />

MONOPARIN 1000IU/ML SOLUTION FOR<br />

INJECTION<br />

1000IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

5000IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

25000IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

1000IU/ML CP PHARMACEUTICALS<br />

LTD<br />

ISRAEL<br />

ISRAEL<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

632 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MONOPARIN 25,000IU/ML SOLUTION FOR<br />

INJECTION<br />

MONOPARIN 5000IU/ML SOLUTION FOR<br />

INJECTION<br />

MONOPARIN CALCIUM SOLUTION FOR<br />

INJECTION<br />

MONOPARIN-CA 25000 IU/ML SOLUTION FOR<br />

INJECTION<br />

25000 IU/ML CP PHARMACEUTICALS<br />

LTD<br />

5000 IU/ML CP PHARMACEUTICALS<br />

LTD<br />

25000IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

25000 IU/ML CP PHARMACEUTICALS<br />

LTD<br />

MONOPAS TABLET 1G MACLEODS<br />

PHARMACEUTICALS LTD<br />

MONOPRIL (ELITEN) TABLETS 10MG BRISTOL MYERS SQUIBB<br />

S.P.A<br />

MONOPRIL (ELITEN) TABLETS 20MG BRISTOL MYERS SQUIBB<br />

S.P.A<br />

MONOSORDIL CONTROLLED RELEASE<br />

CAPS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

INDIA<br />

ITALY<br />

ITALY<br />

60MG ELPEN PHARM. CO. INC. GREECE<br />

MONOSORDIL TABLET 20MG ELPEN S.A GREECE<br />

MONOTARD HM 100 IU/ML 10ML<br />

VIAL<br />

SUSPENSION FOR<br />

INJECTION<br />

MONO-TILDIEM SR 200MG SUSTAINED RELEASE<br />

CAPSULE<br />

MONO-TILDIEM SR 300MG SUSTAINED RELEASE<br />

CAPSULE<br />

NA NOVO NORDISK A/S DENMARK<br />

200MG LABORATOIRES<br />

SYNTHELABO<br />

300MG LABORATOIRES<br />

SYNTHELABO<br />

MONOVAS 10MG TABLET TABLET 10MG MUSTAFA NEVZAT ILAC<br />

SANAYII A.S.<br />

MONOVENT ORAL SOLUTION 1.5MG/5ML LAGAP<br />

PHARMACEUTICALS<br />

LIMITED<br />

MORPHINE SULPHATE INJECTION<br />

BP<br />

SOLUTION FOR<br />

INJECTION<br />

MORPHINE SULPHATE BP SOLUTION FOR<br />

INJECTION<br />

MORPHINE SULPHATE INJ. BP<br />

10MG IN 1ML<br />

MORPHINE SULPHATE INJ. BP<br />

20MG IN 1ML<br />

MORPHINE SULPHATE INJ.BP<br />

15MG IN 1ML<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTIONS<br />

SOLUTION FOR<br />

INJECTIONS<br />

MORPHINE SULPHATE INJECTION SOLUTION FOR<br />

INJECTION<br />

MORPHINE SULPHATE INJECTION SOLUTION FOR<br />

INJECTION<br />

MORPHINE SULPHATE INJECTION<br />

BP<br />

MORPHINE SULPHATE INJECTION<br />

BP<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

15MG/ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

10 MG/ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

1%W/V MACARTHYS<br />

LABORATORIES LIMITED<br />

FRANCE<br />

FRANCE<br />

TURKEY<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

UNITED KINGDOM<br />

2%W/V PL 01883/6177R UNITED KINGDOM<br />

1.5%W/V MACARTHYS<br />

LABORATORIES LIMITED<br />

10MG/1ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

15MG/1ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

60MG/2ML EVANS MEDICAL LIMITED UNITED KINGDOM<br />

30MG/ML EVANS MEDICAL LIMITED UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 633<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MORPHINE SULPHATE INJECTION<br />

BP<br />

MORPHINE SULPHATE INJECTION,<br />

USP<br />

MORPHINE SUPHATE INJECTION<br />

BP<br />

MOTHERWORT COMPOUND<br />

TABLETS<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

15MG/ML EVANS MEDICAL LIMITED UNITED KINGDOM<br />

15.45G/L ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

10MG/ML EVANS MEDICAL LIMITED UNITED KINGDOM<br />

COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

MOTILIUM TABLET 10MG JANSSEN PAKISTAN<br />

MOTILIUM TABLET 10MG JANSSEN PAKISTAN<br />

MOTILIUM SUSPENSION 1MG/ML JANSSEN PAKISTAN<br />

MOTILIUM 10MG TABLET 10MG JANSSEN-CILAG N.V. BELGIUM<br />

MOTILIUM 1MG/ML SUSPENSION 1MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

MOTILIUM BABY SUPPOSITORY 10MG JANSSEN-CILAG N.V. BELGIUM<br />

MOTILIUM CHILDREN SUPPOSITORY 60MG JANSSEN-CILAG N.V. BELGIUM<br />

MOTILIUM CHILDREN SUPPOSITORY 30MG JANSSEN-CILAG N.V. BELGIUM<br />

MOTILIUM SYRUP SYRUP 1MG/ML JANSSEN PAKISTAN<br />

MOTIPRESS TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

MOTIVAL TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

MOTIVAL TABLETS N/A BRISTOL MYERS SQUIBB EGYPT<br />

MOVICOL POWDER FOR ORAL<br />

SOLUTION<br />

MOVICOL POWDER FOR ORAL<br />

SOLUTION<br />

N/A LABORATOIRES<br />

NORGINE PHARMA<br />

FRANCE<br />

N/A NORGINE LIMITED UNITED KINGDOM<br />

MOXEN 250 CAPSULES 250MG AEGIS LTD. CYPRUS<br />

MOXEN 500 CAPSULES 500MG AEGIS LTD. CYPRUS<br />

MOXICLAV POWDER FOR OR.<br />

SUSPENSION<br />

156.25MG/5ML MEDOCHEMIE LTD CYPRUS<br />

MOXICLAV 375MG TABLET N/A MEDOCHEMIE LTD CYPRUS<br />

MOXICLAV 625MG TABLET N/A MEDOCHEMIE LTD CYPRUS<br />

MOXICLAV FORTE DRY POWDER FOR<br />

SUSPENSION<br />

MOXILEN POWDER FOR OR.<br />

SUSPENSION<br />

312MG/5ML MEDOCHEMIE LTD. CYPRUS<br />

125MG/5ML MEDOCHEMIE LTD CYPRUS<br />

MOXILEN 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS<br />

MOXILEN 500MG POWDER FOR INJECTION 500MG MEDOCHEMIE LTD CYPRUS<br />

MOXILEN 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS<br />

MSI 10 MUNDIPHARMA SOLUTION FOR<br />

INJECTION<br />

MSI 20 MUNDIPHARMA SOLUTION FOR<br />

INJECTION<br />

10MG\ML MUNDIPHARMA GMBH GERMANY<br />

20MG/ML MUNDIPHARMA GMBH GERMANY


EN<br />

634 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MST CONTINUS SUSPENSION<br />

30MG<br />

MST CONTINUS SUSPENSION<br />

100MG<br />

MST CONTINUS SUSPENSION<br />

60MG<br />

GRANULES FOR ORAL<br />

SOLUT.<br />

MST CONTINUS TABLETS 100MG MODIFIED RELEASE<br />

TABLET<br />

MST CONTINUS TABLETS 10MG MODIFIED RELEASE<br />

TABLET<br />

MST CONTINUS TABLETS 200MG MODIFIED RELEASE<br />

TABLETS<br />

N/A NAPP LABORATORIES<br />

LIMITED<br />

ORAL SUSPENSION N/A NAPP LABORATORIES<br />

LIMITED<br />

ORAL SUSPENSION N/A NAPP LABORATORIES<br />

LIMITED<br />

100MG NPP LABORATORIES<br />

LIMITED<br />

10MG NAPP LABORATORIES<br />

LIMITED<br />

200MG NAPP LABORATORIES<br />

LIMITED<br />

MST CONTINUS TABLETS 30MG TABLETS 30MG NAPP LABORATORIES<br />

LIMITED<br />

MST CONTINUS TABLETS 60MG MODIFIED RELEASE<br />

TABLETS<br />

60MG NAPP LABORATORIES<br />

LIMITED<br />

MUCAINE SUSPENSION N/A JOHN WYETH &<br />

BROTHER LTD<br />

MUCAINE SUSPENSION ORAL SUSPENSION N/A JOHN WYETH &<br />

BROTHER LTD<br />

MUCICLAR SYRUP 0.3% W/V VECCHI & C PIAM<br />

S.A.P.A.<br />

MUCICLAR RETARD CAPSULE 75MG VECCHI & C PIAM<br />

S.A.P.A.<br />

MUCICLAR SIROP ADULTES SYRUP 5G/100ML PARKE-DAVIS AFRIQUE<br />

DE L'OUEST<br />

MUCICLAR SIROP ENFANTS ET<br />

NOURRISSONS<br />

SYRUP 2G/100ML PARKE-DAVIS AFRIQUE<br />

DE L'OUEST<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

SENEGAL<br />

SENEGAL<br />

MUCOBROXOL RETARD TABLETS 75MG MUNDIPHARMA GMBH GERMANY<br />

MUCOBROXOL 60 EFFERVESCENT TABLETS 60MG MUNDIPHARMA GMBH GERMANY<br />

MUCOBROXOL SYRUP SYRUP N/A MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

MUCOCIS SYRUP 5% W/V FONTEN FARMACEUTICI<br />

S.R.L.<br />

MUCODYNE PAEDIATRIC SYRUP<br />

125MG<br />

CYPRUS<br />

ITALY<br />

ORAL SOLUTION 125MG/5ML MAY & BAKER LIMITED UNITED KINGDOM<br />

MUCODYNE SYRUP 250MG/5ML ORAL SOLUTION 250MG/5ML MAY & BAKER LIMITED UNITED KINGDOM<br />

MUCOFALK ORANGE GRANULES 3.25G DR. FALK PHARMA<br />

GMBH<br />

MUCOFALK APPLE GRANULES 3.25G DR. FALK PHARMA<br />

GMBH<br />

GERMANY<br />

GERMANY<br />

MUCOGEL SUSPENSION N/A PHARMAX LIMITED UNITED KINGDOM<br />

MUCOPRONT CAPSULES 375MG HEINRICH MACK NACHF GERMANY<br />

MUCOPRONT SYRUP SOLUTION 5G/100G HEINRICH MACK NACHF GERMANY<br />

MUCOSOLVAN AMP 15MG/2ML BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 635<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MUCOSOLVAN LIQUID 15MG/5ML BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

MUCOSOLVAN LIQUID 30MG/5ML BOEHRINGER INGELHEIM<br />

KG<br />

MUCOSOLVAN SOLUTION 15MG/2ML BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

MUCOSOLVAN SOLUTION 30MG/2ML BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

MUCOSOLVAN TABLETS 30MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

MUCOSOLVAN TABLETS 60MG BOEHRINGER INGELHEIM<br />

KG<br />

MUCOSOLVAN L.A. CAPSULES 75MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

MUCOTREIS SYRUP 5G/100ML ECOBI FARMACEUTICI<br />

S.A.S.<br />

MUCOTREIS POWDER 0.3G/BAG ECOBI FARMACEUTICI<br />

S.A.S<br />

MUCOTREIS SYRUP 2G/100ML ECOBI FARMACEUTICI<br />

S.A.S<br />

MULTIPARIN SOLUTION FOR<br />

INJECTION<br />

MULTIPARIN SOLUTION FOR<br />

INJECTION<br />

MULTIPARIN SOLUTION FOR<br />

INJECTION<br />

MULTIPARIN 1000IU/ML(5ML<br />

VIALS)<br />

SOLUTION FOR<br />

INJECTION<br />

MULTIPARIN 25,000IU/ML SOLUTION FOR<br />

INJECTION<br />

MULTIPARIN 5000IU/ML(IN 5ML<br />

VIALS)<br />

SOLUTION FOR<br />

INJECTION<br />

1000IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

5000IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

25000IU/ML CP PHARMACEUTICALS<br />

LTD.<br />

1000 IU/ML CP PHARMACEUTICALS<br />

LTD<br />

25000 IU / ML CP PHARMACEUTICALS<br />

LTD<br />

5000 IU/ML CP PHARMACEUTICALS<br />

LTD<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

MULTIVITAMIN COATED TABLETS NA PHARMAMED LTD. MALTA<br />

MULTIVITAMIN DROPS ORAL DROPS N/A WARNER-LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

MULTIVITAMINS CAPSULE N/A SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

ITALY<br />

ITALY<br />

ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MUMPSVAX VACCINE 5000 TCID50 MERCK SHARP & DOHME NETHERLANDS<br />

MUPHORAN POWDER AND SOL FOR<br />

IV INF<br />

200MG/4ML LES LABORATOIRES<br />

SERVIER<br />

FRANCE<br />

MURINE PLUS EYE DROPS N/A ABBOTT PAKISTAN<br />

MURINE TEARS LUBRICANT EYE DROPS N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

MURINE TEARS PLUS LUB.<br />

REDNESS RELIEVER<br />

EYE DROPS N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

MUSE 1000 MICROGRAMS URETHRAL STICK 1000MCG VIVUS UK UNITED KINGDOM


EN<br />

636 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MUSE 125 MICROGRAMS URETHRAL STICK 125 MCG VIVUS UK UNITED KINGDOM<br />

MUSE 250 MICROGRAMS URETHRAL STICK 250 MCG VIVUS UK UNITED KINGDOM<br />

MUSE 500 MICROGRAMS URETHRAL STICK 500MCG VIVUS UK UNITED KINGDOM<br />

MXL CAPSULES 120MG MODIFIED RELEASE<br />

CAPSULE<br />

MXL CAPSULES 150MG MODIFIED RELEASE<br />

CAPSULES<br />

MXL CAPSULES 200MG MODIFIED RELEASE<br />

CAPSULE<br />

MXL CAPSULES 60MG MODIFIED RELEASE<br />

CAPSULE<br />

120MG NAPP LABORATORIES<br />

LIMITED<br />

150MG NAPP LABORATORIES<br />

LIMITED<br />

200MG NAPP LABORATORIES<br />

LIMITED<br />

60MG NAPP<br />

PHARMACEUTICALS<br />

LIMITED<br />

MYCETIN LYOPHILISED EYE DROPS 25MG/VIAL FARMIGEA SPA ITALY<br />

MYCIL ATHLETE'S FOOT SPRAY TOPICAL SPRAY 0.12%W/W CROOKES HEALTHCARE<br />

LIMITED<br />

MYCIL OINTMENT OINTMENT N/A CROOKES HEALTHCARE<br />

LIMITED<br />

MYCIL POWDER TOPICAL POWDER N/A CROOKES HEALTHCARE<br />

LIMITED<br />

MYCOHEAL VAGINAL SUPPOSITORIES 200MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

MYCOHEAL CREAM NA DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD<br />

MYCOHEAL HC CREAM N/A DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

MYCOHEAL HC CREAM CREAM NA DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT<br />

MYCOSPOR GEL 1% W/W BAYER VITAL GMBH &<br />

CO. KG<br />

MYCOSPOR CREAM 0.01G/G BAYER VITAL GMBH &<br />

CO. KG<br />

MYCOSPOR SOLUTION 0.01G/ML BAYER VITAL GMBH &<br />

CO. KG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

JORDAN<br />

JORDAN<br />

JORDAN<br />

JORDAN<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

MYCOSPOR CREAM N/A BAYER PAKISTAN<br />

MYCOSPOR CREAM 0.01G/G BAYER PAKISTAN<br />

MYCOSTATIN CREAM 100,000 UI / 1G E R SQUIBB & SONS LTD UNITED KINGDOM<br />

MYCOSTATIN ORAL SUSPENSION 100,000 UI / ML SQUIBB INDUSTRIA<br />

FARMACEUTICA, S.A.<br />

MYCOSTATIN OINTMENT 100,000 UI / G SQUIBB INDUSTRIA<br />

FARMACEUTICA, S.A.<br />

MYCOSTATIN BABY OINTMENT OINTMENT 100,000UI / G SQUIBB INDUSTRIA<br />

FARMACEUTICA, S.A.<br />

MYDRIATICUM EYE DROPS 5MG/ML CIBA VISION AG SWITZERLAND<br />

SPAIN<br />

SPAIN<br />

SPAIN


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 637<br />

Trade Name Dosage Form Dose MA Holder Country<br />

MYDRIATICUM 0.5% EYE DROPS 5.00MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

MYDRILATE EYE DROPS 1% INTRAPHARM<br />

LABORATORIES LIMITED<br />

MYDRILATE EYE DROPS 0,50% INTRAPHARM<br />

LABORATORIES LIMITED<br />

MYLERAN TABLETS 2MG THE WELLCOME<br />

FOUNDATION LTD.<br />

MYLERAN FILM COATED TABLET 2MG THE WELLCOME<br />

FOUNDATION LTD T/A<br />

GLAXO WELLCOME<br />

MYLERAN FILM COATED TABLETS 2MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

MYLERAN TABLETS 2MG COATED TABLETS 2MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

MYOCRISIN INJECTION SOLUTION FOR<br />

INJECTION<br />

MYOCRISIN INJECTION 10% SOLUTION FOR<br />

INJECTION<br />

MYOCRISIN INJECTION 4% SOLUTION FOR<br />

INJECTION<br />

MYOCRISTIN INJECTION SOLUTION FOR<br />

INJECTION<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

10% W/V JHC HEALTHCARE LTD UNITED KINGDOM<br />

10% W/V JHC HEALTHCARE<br />

LIMITED<br />

4% W/V JHC HEALTHCARE<br />

LIMITED<br />

IRELAND<br />

IRELAND<br />

4% JHC HEALTHCARE LTD UNITED KINGDOM<br />

MYOFLEX TABLET SEE REMARKS PRIME<br />

PHARMACEUTICAL<br />

MYOGESIC TABLETS N/A DAR AL DAWA<br />

DEVELOPMENT ND<br />

INVESTMENT CO LIMITED<br />

MYOVIEW POWDER FOR INJECTION 0.23MG/VIAL NYCOMED AMERSHAM<br />

PLC<br />

MYPRODOL CAPSULES NA ADCOCK INGRAM<br />

LIMITED<br />

MALAYSIA<br />

JORDAN<br />

UNITED KINGDOM<br />

SOUTH AFRICA<br />

MYSOLINE TABLETS 250MG ZENECA LIMITED UNITED KINGDOM<br />

NAAXIA EYE DROPS 38MG/ML CIBA VISION AG SWITZERLAND<br />

NAAXIA EYE DROPS 38MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

NABUGESIC TABLETS 500MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD<br />

NACL 5% EYE DROPS 50MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

SWITZERLAND<br />

JORDAN<br />

SWITZERLAND<br />

NACL 5% DISPERSA EYE DROPS 5% W/V CIBA VISION AG SWITZERLAND<br />

NADITONE TABLETS 500MG KLEVA LTD. GREECE<br />

NADRIFOR TABLETS 10MG KLEVA LTD GREECE<br />

NAFORDYL TABLETS 20MG KLEVA LIMITED GREECE<br />

NAFTAZOLINA NASAL DROPS, SPRAY<br />

SOLN.<br />

0.2% W/V BRUSCHETTINI SRL ITALY


EN<br />

638 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NAFTAZOLINA NASAL DROPS,<br />

SOLUTION<br />

2G/100ML BRUSCHETTINI SRL ITALY<br />

NALCROM CAPSULES 100MG CAPSULES 100MG FISONS LIMITED T/A<br />

RHONE-POULENC RORER<br />

NALCROM CAPSULES 100MG CAPSULE 100MG FISONS LTD T/A RHONE-<br />

POULENC RORER<br />

NALIDIX 500 TABLET 0.5G DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

JORDAN<br />

NALIDIXIC ACID TABLETS 500MG PHARMAMED LTD. MALTA<br />

NALIDIXIC ACID SUSPENSION ORAL SUSPENSION 300MG/5ML ROSEMONT<br />

PHARMACEUTICALS<br />

LIMITED<br />

NALION 0.5MG TABLET 0.5MG MEDOCHEMIE LTD CYPRUS<br />

NALOXONE HYDROCHLORIDE SOLUTION FOR<br />

INJECTION<br />

NALOXONE HYDROCHLORIDE<br />

INJECTION<br />

NALOXONE HYDROCHLORIDE<br />

INJECTION<br />

NALOXONE HYDROCHLORIDE<br />

INJECTION<br />

NALOXONE HYDROCHLORIDE<br />

INJECTION USP<br />

NALOXONE HYDROCHLORIDE<br />

MINIJET<br />

NALOXONE HYDROCHLORIDE<br />

MINJET<br />

NALOXONE HYDROCHLORIDE<br />

USP<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

NALOXONE HYDROCHLORIDRE SOLUTION FOR<br />

INJECTION<br />

NALOXONE INJ MINIJET SOLUTION FOR<br />

INJECTION<br />

NALOXONE INJECTION MINIJET SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

0.4MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

0.02MG/ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

0.04MG/1ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

40MCG/2ML F.H. FAULDING & CO LTD<br />

(T/A DAVID BULL LABS)<br />

400MICROGRAMS ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

0.4MG/1ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

0.8MG/2ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

20 MICROGRAM ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

IRELAND<br />

IRELAND<br />

AUSTRALIA<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

0.02MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

0.8MG/2ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

0.4MG/1ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

NALOXONE MERCK 0.4MG/ML SOLUTION FOR INJ. 0.4MG/ML MERCK GENERIQUES FRANCE<br />

NANOTIV POWDER FOR INJECTION 500IU (I+II) PHARMACIA & UPJOHN<br />

AB<br />

NANOTIV POWDER FOR INJECTION 1000IU(I+II) PHARMACIA & UPJOHN<br />

AB<br />

NANOTIV 1000IU POWDER AND<br />

SOLVENT<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWEDEN<br />

SWEDEN<br />

POWDER AND SOLVENT N/A BIOVITRUM AB SWEDEN


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 639<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NANOTIV POWDER AND<br />

SOLVENT<br />

POWDER AND SOLVENT N/A BIOVITRUM AB SWEDEN<br />

NAPHCON-A OPHTHALMIC SOLUTION N/A S.A. ALCON-COUVREUR<br />

N.V.<br />

BELGIUM<br />

NAPROREX 250 TABLETS 250MG AEGIS LTD. CYPRUS<br />

NAPROREX 375 TABLETS 375MG AEGIS LTD. CYPRUS<br />

NAPROREX 500 TABLETS 500MG AEGIS LTD. CYPRUS<br />

NAPROREX EC 250 TABLETS 250MG AEGIS LTD. CYPRUS<br />

NAPROREX EC 375 TABLETS 375MG AEGIS LTD. CYPRUS<br />

NAPROREX EC 500 TABLETS 500MG AEGIS LTD. CYPRUS<br />

NAPROSYN 250 TABLET 250MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

NAPROSYN 500 TABLET 500MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

NAPROSYN EC 250MG TABLET 250MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

NAPROSYN EC 500MG TABLET 500MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

NAPROVAL CAPSULES 250MG LABORATORIO REIG<br />

JOFRE S.A<br />

NAPROXEN TABLETS 250MG NORTON HEALTHCARE<br />

LIMITED<br />

NAPROXEN TABLETS 500MG NORTON HEALTHCARE<br />

LIMITED<br />

NAPROXEN BP 250MG TABLET 250MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

NAPROXEN BP 500MG TABLET 500MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

NAPROXEN TABLETS BP TABLETS 250MG CP PHARMACEUTICALS<br />

LTD.<br />

NAPROXEN TABLETS BP TABLETS 500MG CP PHARMACEUTICALS<br />

LTD.<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SPAIN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NAPROXEN-MEPHA 500 LACTAB 500MG MEPHA PHARMA AG SWITZERLAND<br />

NARAMIG TABLETS 2.5MG COATED TABLET 2.5MG GLAXO WELLCOME UK<br />

LTD<br />

NARCAN SOLUTION FOR<br />

INJECTION<br />

NARIXAN HARD GELATIN CAPSULE<br />

SR.<br />

0.4MG/ML ENDO<br />

PHARMACEUTICALS INC.<br />

120MG ALFA WASSERMANN<br />

S.P.A.<br />

NARIXAN CAPSULE 120MG ALFA WASSERMANN<br />

S.P.A.<br />

NAROP SOL. FOR INJ. AND IV<br />

INF.<br />

NAROP SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

ITALY<br />

ITALY<br />

2MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

7.5MG/ML ASTRA LAKEMEDEL AB SWEDEN


EN<br />

640 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NAROP SOLUTION FOR<br />

INJECTION<br />

NAROPIN SOL. FOR INJ. AND IV<br />

INF.<br />

NAROPIN SOLUTION FOR<br />

INJECTION<br />

NAROPIN SOLUTION FOR<br />

INJECTION<br />

10MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

2MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

7.5MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

10MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

NASACORT NASAL SPRAY 0.055% W/W MAY & BAKER LIMITED<br />

T/A RHONE POULENC<br />

RORER<br />

NASACORT NASAL SPRAY 0.055% W/W MAY & BAKER LIMITED<br />

T/A RHONE POULENC<br />

RORER<br />

NASACORT AQ NASAL SPRAY 55MCG/ACTUATION RHONE-POULENC RORER<br />

PHARMACEUTICALS INC.<br />

NASELIN NASAL SPRAY SOLUTION 0.05%W/V CIPLA LIMITED INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

NASENSPRAY E RATIOPHARM NASAL SPRAY SOLUTION 0.09MG/0.09ML RATIOPHARM GMBH GERMANY<br />

NASENSPRAY K RATIOPHARM NASAL SPRAY SOLUTION 0.045MG/0.09ML RATIOPHARM GMBH GERMANY<br />

NASONEX NASAL SPRAY 50MG/G SCHERING — PLOUGH<br />

S.A.<br />

NAT PHOS. NEW ERA NO.10 NAT<br />

PHOS<br />

NAT. MUR. NEW ERA BIOCHEMIC<br />

NO.9<br />

NAT. SULPH. — NEW ERA NO.11<br />

NAT SULPH<br />

TISSUE SALT TABLETS<br />

NO.10<br />

TISSUE SALT TABLET NO.<br />

9<br />

TISSUE SALT TABLETS<br />

NO.11<br />

NA NEW ERA<br />

LABORATORIES LIMITED<br />

NA NEW ERA<br />

LABORATORIES LIMITED<br />

NA NEW ERA<br />

LABORATORIES LIMITED<br />

NATRASLEEP FILM COATED TABLETS N/A PETER BLACK<br />

HEALTHCARE LIMITED<br />

NATRILIX FILM-COATED TABLET 2.5MG LES LABORATOIRES<br />

SERVIER<br />

BELGIUM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

NATRILIX TABLETS 2.5MG SERVIER PAKISTAN<br />

NATRILIX COATED TABLETS 2.5MG. SERVIER EGYPT<br />

INDUSTRIES LTD<br />

EGYPT<br />

NATRILIX 2.5MG TABLET 2.5MG SERVIER PAKISTAN<br />

NATRILIX SR SUST. REL. COATED<br />

TABLET<br />

1.5MG LES LABORATOIRES<br />

SERVIER<br />

FRANCE<br />

NATRILIX SR TABLETS 1.5MG SERVIER PAKISTAN<br />

NATRILIX SR TABLETS 1.5MG SERVIER PAKISTAN<br />

NATRILIX SR COATED TABLET 1.5 MG SERVIER EGYPT<br />

INDUSTRIES LTD.<br />

NATRILIX SR 1.5MG SUST. REL. COATED<br />

TABLET<br />

EGYPT<br />

1.5MG LABORATOIRES SERVIER FRANCE<br />

NAUTISOL 12.5MG LIQUID FOR INJECTION 12.5MG/2ML MEDOCHEMIE LTD CYPRUS<br />

NAUTISOL 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 641<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NAVELBINE 10MG/1ML INJECTABLE SOLUTION 10MG/1ML PIERRE FABRE<br />

MEDICAMENT<br />

NAVELBINE 50MG/5ML INJECTABLE SOLUTION 50MG/5ML PIERRE FABRE<br />

MEDICAMENT<br />

FRANCE<br />

FRANCE<br />

NAVIDOXINE TABLET N/A U.C.B. S.A. BELGIUM<br />

NAVOBAN CAPSULES 5MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

NAVOBAN SOLUTION FOR<br />

INJECTION<br />

5MG/5ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

NEBILET 5MG TABLET 5MG MENARINI<br />

INTERNATIONAL<br />

OPERATIONS<br />

LUXEMBOURG S.A.<br />

NEGRAM 500MG TABLETS TABLET 500MG SANOFI WINTHROP<br />

LIMITED<br />

NEGRAM SUSPENSION 6% W/V ORAL SUSPENSION 6% W/V SANOFI WINTHROP<br />

LIMITED<br />

NELSONS CHILBLAIN CREAM CREAM 9%V/W A NELSONS AND<br />

COMPANY LTD<br />

NEO BOROCILLINA MOUTH WASH 24MG/100ML ALFA WASSERMANN<br />

S.P.A.<br />

NEO BOROCILLINA TABLETS N/A ALFA WASSERMANN<br />

S.P.A.<br />

NEO BOROCILLINA ORAL SPRAY 600MG/100ML ALFA WASSERMANN<br />

S.P.A.<br />

NEO BOROCILLINA TABLETS N/A ALFA WASSERMANN<br />

S.P.A.<br />

NEO BOROCILLINA ‘C’ TABLET N/A ALFA WASSERMANN<br />

S.P.A.<br />

NEO BOROCILLINA ‘C’ SENZ/ZUC TABLET N/A ALFA WASSERMANN ITALY<br />

NEO BOROCILLINA C TABLET N/A ALFA WASSERMANN<br />

S.P.A.<br />

NEO BOROCILLINA SENZA<br />

ZUCCHERO<br />

NEO BOROCILLINA TOSSE SOLUTION FOR ORAL<br />

USE<br />

NEO BOROCILLINA TOSSE MOUTH SOLUBLE<br />

TABLET<br />

TABLET N/A ALFA WASSERMANN<br />

S.P.A.<br />

SWITZERLAND<br />

SWITZERLAND<br />

GERMANY<br />

UNITED KINGDOM<br />

FRANCE<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

N/A ALFA WASSERMANN ITALY<br />

N/A ALFA WASSERMANN<br />

S.P.A.<br />

NEO-BUCOSIN LOZENGE N/A SYNPHARMA AG SWITZERLAND<br />

NEODIPAR TABLETS TABLETS 500MG HOECHST PAKISTAN<br />

NEO-MEDROL ACNE LOTION LOTION N/A PHARMACIA & UPJOHN<br />

INC.<br />

NEO-MERCAZOLE TABLET 20MG ROCHE PRODUCTS<br />

LIMITED<br />

NEO-MERCAZOLE TABLETS 5MG TABLET 5MG ROCHE PRODUCTE<br />

LIMITED<br />

NEOMIGRAN NASAL SPRAY 4MG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

ITALY<br />

CANADA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND


EN<br />

642 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NEO-NACLEX TABLET 5MG GOLDSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

UNITED KINGDOM<br />

NEORAL 25MG CAPSULE 25MG NOVARTIS PAKISTAN<br />

NEORAL ORAL SOLUTION ORAL SOLUTION 100 MG/ML NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

NEORAL SOFT GELATIN CAPSULE SOFT GELATIN CAPSULES 25 MG NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

NEORECORMON 10000IU POWDER AND SOLVENT<br />

F. INJ.<br />

NEORECORMON 1000IU POWDER AND SOLVENT<br />

F. INJ.<br />

NEORECORMON 2000IU POWDER AND SOLVENT<br />

F. INJ.<br />

NEORECORMON 5000IU POWDER AND SOLVENT<br />

F. INJ.<br />

NEOSPECT KIT FOR RADIOPHARM<br />

PREP.<br />

NEOSTIGMINE SOLUTION FOR<br />

INJECTION<br />

NEOSTIGMINE INJECTION SOLUTION FOR<br />

INJECTION<br />

NEOSTIGMINE INJECTION BP<br />

2.5.MG/ML<br />

10000IU/ML ROCHE REGISTRATION<br />

LIMITED<br />

1000IU/ML ROCHE REGISTRATION<br />

LIMITED<br />

2000IU/ML ROCHE REGISTRATION<br />

LIMITED<br />

5000IU/ML ROCHE REGISTRATION<br />

LIMITED<br />

IRELAND<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

POWDER FOR INJECTION 47MCG/KIT NYCOMED IMAGING AS EUROPEAN COMMUNITY<br />

SOLUTION FOR<br />

INJECTION<br />

NEOSTIGMINE METHYLSULFATE SOLUTION FOR<br />

INJECTION<br />

NEOSTIGMINE METHYLSULPHATE SOLUTION FOR<br />

INJECTION<br />

NEOSTIGMINE METHYLSULPHATE<br />

INJ INTRAMED<br />

NEOSTIGMINE<br />

METHYLSULPHATE-FRESENIUS<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

0.5MG/1ML PHARMAMED<br />

PARENTERALS LTD.<br />

2.5MG/ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

2.5.MG/ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

MALTA<br />

IRELAND<br />

IRELAND<br />

1MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

2.5MG/ML PHOENIX<br />

PHARMACEUTICALS LTD.<br />

2.5MG/ML BODENE (PROPRIETARY)<br />

LIMITED T/A INTRAMED<br />

2.5MG/ML BODENE (PROPRIETARY)<br />

LIMITED T/A INTRAMED<br />

NEOTIGASON CAPSULE 25MG ROCHE PHARMA<br />

(SCHWEIZ) LITD<br />

NEOTIGASON CAPSULE 10MG ROCHE PHARMA<br />

(SCHWEIZ) LTD<br />

NEOXENE VAGINAL OVULES 10MG FARMACEUTICI ECOBI<br />

S.A.S<br />

UNITED KINGDOM<br />

SOUTH AFRICA<br />

REPUBLIC OF SOUTH<br />

AFRICA<br />

SWITZERLAND<br />

SWITZERLAND<br />

NEPHRIL TABLETS 1MG PFIZER LIMITED UNITED KINGDOM<br />

NERISONE CREAM 1MG/G SCHERING AG GERMANY<br />

NERISONE OINTMENT 1MG/G SCHERING AG GERMANY<br />

NERISONE CREAM 0.1G/100G SCHERING SPA ITALY<br />

NERISONE OINTMENT 0.1G/100G SCHERING SPA ITALY<br />

NERISONE FATTY OINTMENT 0.1G/100G SCHERING SPA ITALY<br />

ITALY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 643<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NERISONE C CREAM N/A SCHERING SPA ITALY<br />

NERISONE C CREAM N/A SCHERING PAKISTAN<br />

NERISONE CREAM CREAM 1MG/G SCHERING PAKISTAN<br />

NETROMICIN SOLUTION FOR<br />

INJECTIONS<br />

NETROMICIN/NETROMYCIN SOLUTION FOR<br />

INJECTION<br />

NETROMYCIN SOLUTION FOR<br />

INJECTION<br />

NETROMYCIN SOLUTION FOR<br />

INJECTION<br />

NETROMYCINE/NETROMYCIN SOLUTION FOR<br />

INJECTION<br />

NEUMEGA SUBCUTANEOUS<br />

INJECTION<br />

150MG/1.5ML SCHERING-PLOUGH<br />

NV/SA<br />

BELGIUM<br />

50MG/2ML SCHERING-PLOUGH S.A. BELGIUM<br />

50MG/2ML SCHERING-PLOUGH<br />

NV/SA<br />

50MG/ML SCHERING-PLOUGH<br />

LIMITED<br />

BELGIUM<br />

150MG/1.5ML SCHERING-PLOUGH S.A. BELGIUM<br />

5MG/ML GENERICS INSTITUTE,<br />

INC.<br />

NEUPOGEN VIAL 30MU AND 48MU ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

SWITZERLAND<br />

NEUROBAT SUGAR COATED TABLET N/A PT INTERBAT INDONESIA<br />

NEUROLITE DRY SUBSTANCE AND<br />

SOLVENT<br />

N/A DUPONT PHARMA GMBH GERMANY<br />

NEUROMULTIVIT FILM COATED TABLETS N/A LANNACHER HEILMITTEL<br />

GES.M.B.H.<br />

AUSTRIA<br />

NEURONTIN 100MG CAPSULE 100MG PARKE-DAVIS GMBH GERMANY<br />

NEURONTIN 300MG CAPSULE 300MG PARKE-DAVIS GMBH GERMANY<br />

NEURONTIN 400MG CAPSULE 400MG PARKE-DAVIS GMBH GERMANY<br />

NEURONTIN CAPSULES 100MG CAPSULE 100MG WARNER LAMBERT (UK)<br />

LIMITED T/A PARKE<br />

DAVIS<br />

NEURONTIN CAPSULES 100MG CAPSULE 100MG WARNER LAMBERT (UK)<br />

LTD. T/A PARKE DAVIS<br />

NEURONTIN CAPSULES 300MG CAPSULE 300MG WARNER LAMBERT (UK)<br />

LTD. T/A PARKE DAVIS<br />

NEURONTIN TABLETS 600MG FILM COATED TABLET 600MG WARNER LAMBERT (UK)<br />

LTD. T/A PARKE DAVIS<br />

NEURONTIN TABLETS 800MG FILM COATED TABLET 800MG WARNER LAMBERT (UK)<br />

LTD. T/A PARKE DAVIS<br />

NEURO-RATIOPHARM N<br />

FILMTABLETTEN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FILM COATED TABLET N/A RATIOPHARM GMBH GERMANY<br />

NEURORUBIN LACTABS N/A MEPHA PHARMA AG SWITZERLAND<br />

NEURORUBINE SOLUTION FOR<br />

INJECTION<br />

N/A MEPHA PHARMA AG SWITZERLAND<br />

NEURORUBINE FORTE LACTAB N/A MEPHA PHARMA AG SWITZERLAND<br />

NEUTROMAX 300MCG (30 M.U.I) SOLUTION FOR<br />

INJECTION<br />

300MCG INSTITUTO SIDUS S.A. ARGENTINA


EN<br />

644 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NEUTROMAX 480MCG (48 M.U.I) SOLUTION FOR<br />

INJECTION<br />

480MCG INSTITUTO SIDUS S.A. ARGENTINA<br />

NEVIRAN TABLET 400MG FONTEN FARMACEUTICI<br />

S.R.L.<br />

NEVIRAN CREAM 5% W/W FONTEN FARMACEUTICI<br />

S.R.L.<br />

NEVPARIN SOLUTION FOR<br />

INJECTION<br />

NEW ERA COMBINATION A —<br />

SCIATICA<br />

NEW ERA COMBINATION B (SEE<br />

REMARKS)<br />

NEW ERA COMBINATION C (SEE<br />

REMARKS)<br />

25000IU/5ML MUSTAFA NEVZAT ILAC<br />

SANAYII AS<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

NEW ERA COMBINATION E SALT TABLETS N/A NEW ERA —<br />

LABORATORIES LTD —<br />

UK<br />

NEW ERA COMBINATION F (SEE<br />

REMARKS)<br />

NEW ERA COMBINATION G (SEE<br />

REMARKS)<br />

NEW ERA COMBINATION H (SEE<br />

REMARKS)<br />

NEW ERA COMBINATION I (SEE<br />

REMARKS)<br />

NEW ERA COMBINATION J (SEE<br />

REMARKS)<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

NEW ERA COMBINATION K TISSUE SALT TABLETS 6X NEW ERA<br />

LABORATORIES LIMITED<br />

NEW ERA COMBINATION L (SEE<br />

REMARKS)<br />

NEW ERA COMBINATION M (SEE<br />

REMARKS)<br />

NEW ERA COMBINATION N (SEE<br />

REMARKS)<br />

NEW ERA COMBINATION P (SEE<br />

REMARKS)<br />

NEW ERA COMBINATION R (SEE<br />

REMARKS)<br />

NEW ERA COMBINATION S (SEE<br />

REMARKS)<br />

NEW ERA COMBINATRION D (SEE<br />

REMARKS)<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

NEW ERA NO.12 SILICA TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

NEW ERA NO.6 KALI. PHOS. TISSUE SALT TABLETS NA NEW ERA<br />

LABORATORIES LIMITED<br />

NEXIUM GASTRO-RESISTANT<br />

TABLET<br />

ITALY<br />

ITALY<br />

TURKEY<br />

40MG HASSLE LAKEMEDEL AB SWEDEN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 645<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NEXIUM GASTRO-RESISTANT<br />

TABLET<br />

20MG HASSLE LAKEMEDEL AB SWEDEN<br />

NICARDIA CAPSULES 10MG CAPSULES 10MG J.B. CHEMICALS &<br />

PHARMACEUTICALS LTD<br />

NICARDIA RETARD-10 FILM COATED TABLET 10MG J.B.CHEMICALS &<br />

PHARMACEUTICALS LTD<br />

NICARDIA RETARD-20 FILM COATED TABLET 20MG J.B.CHEMICALS &<br />

PHARMACEUTICALS LTD<br />

NICEF CAPSULES 250MG GALEN LIMITED UNITED KINGDOM<br />

NICEF CAPSULES 500MG GALEN LIMITED UNITED KINGDOM<br />

NICOBREVIN CAPSULE N/A NICOBREVIN UNITED KINGDOM<br />

NICO-HEPATOCYN COATED TABLET N/A J.URIACH & CIA. S.A. SPAIN<br />

NICORETTE MEDICATED CHEWING<br />

GUM<br />

NICORETTE MEDICATED CHEWING<br />

GUM<br />

2MG PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

4MG PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

NICORETTE TRANSDERMAL PATCHES 5MG/16 HOURS PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

NICORETTE TRANSDERMAL PATCHES 10MG/16HOURS PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

NICORETTE TRANSDERMAL PATCHES 15MG/16HOURS PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

NICORETTE MEDICATED CHEWING<br />

GUM<br />

NICORETTE MEDICATED CHEWING<br />

GUM<br />

INDIA<br />

INDIA<br />

INDIA<br />

SWEDEN<br />

SWEDEN<br />

SWEDEN<br />

SWEDEN<br />

SWEDEN<br />

2MG PHARMACIA SVERIGE AB SWEDEN<br />

4MG PHARMACIA SVERIGE AB SWEDEN<br />

NICORETTE TRANSDERMAL PATCH 5MG/16HOURS PHARMACIA SVERIGE AB SWEDEN<br />

NICORETTE TRANSDERMAL PATCH 10MG/16HOURS PHARMACIA SVERIGE AB SWEDEN<br />

NICORETTE TRANSDERMAL PATCH 15MG/16HOURS PHARMACIA SVERIGE AB SWEDEN<br />

NICORETTE INHALATOR INHALATION VAPOUR 10MG/CARTRIDGE PHARMACIA LIMITED UNITED KINGDOM<br />

NICORETTE INHALOR LIQUID FOR<br />

INHALATION<br />

NICORETTE MINT MEDICATED CHEWING<br />

GUM<br />

NICORETTE MINT MEDICATED CHEWING<br />

GUM<br />

NICORETTE MINT MEDICATED CHEWING<br />

GUM<br />

NICORETTE MINT MEDICATED CHEWING<br />

GUM<br />

10MG/CARTRIDGE PHARMACIA & UPJOHN<br />

LIMITED<br />

2MG PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

4MG PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

UNITED KINGDOM<br />

SWEDEN<br />

SWEDEN<br />

2MG PHARMACIA SVERIGE AB SWEDEN<br />

4MG PHARMACIA SVERIGE AB SWEDEN<br />

NICOTINAMIDE TABLET TABLET 50MG CAMDEN INDUSTRIES (M)<br />

SDN. BHD.<br />

NICOTINELL TTS 10 TRANSDERMAL PATCH 17.5MG/PATCH NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

MALAYSIA<br />

SWITZERLAND


EN<br />

646 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NICOTINELL TTS 20 TRANSDERMAL PATCH 35MG/ PATCH NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

NICOTINELL TTS 30 TRANSDERMAL PATCH 52.5MG/PATCH NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

SWITZERLAND<br />

NIDAGYL 200 TABLETS 200MG AEGIS LTD. CYPRUS<br />

NIDAGYL 400 TABLETS 400MG AEGIS LTD. CYPRUS<br />

NIDAGYL 500 CAPSULES 500MG AEGIS LTD. CYPRUS<br />

NIDAGYL 500 TABLETS 500MG AEGIS LTD. CYPRUS<br />

NIDOL TABLETS 100MG POLIPHARM CO. LTD. THAILAND<br />

NIDOL SUSPENSION 1G/100ML POLIPHARM CO. LTD. THAILAND<br />

NIFECARD CAPSULES 10MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

NIFECARD-10 CAPSULES 10MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

JORDAN<br />

JORDAN<br />

NIFEDI-DENK 10 RETARD RETARD TABLETS 10MG E.DENK OHG GERMANY<br />

NIFEDI-DENK 20 RETARD RETARD TABLETS 20MG E.DENK OHG GERMANY<br />

NIFEDIPINE CAPSULES 5MG NORTON HEALTHCARE<br />

LIMITED<br />

NIFEDIPINE CAPSULES 10MG NORTON HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NIFEDIPINE CAPSULES 10MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

NIFEDIPINE SLOW RELEASE<br />

(NIFELAT RETARD)<br />

SLOW RELEASE TABS 20MG CIPLA LIMITED INDIA<br />

NIFELAT TABLETS 10MG REMEDICA LTD CYPRUS<br />

NIFELAT-10 CAPSULES 10MG CIPLA LIMITED INDIA<br />

NIFELAT-10 CAPSULE 10MG CIPLA LIMITED INDIA<br />

NIFLUGEL 2.5 % PERCUTANEOUS GEL 2.5G/100G LABORATOIRES UPSA FRANCE<br />

NIFLURIL 250MG CAPSULE 250MG LABORATOIRES UPSA FRANCE<br />

NIFLURIL FOR CHILDREN 400MG SCORED SUPPOSITORY 0.4G LABORATOIRES UPSA FRANCE<br />

NIFOPRESS RETARD TABLETS<br />

20MG<br />

NIFTEN MODIFIED RELEASE<br />

CAPSULES<br />

COATED TABLET 20MG GOLDSHIELD GROUP PLC UNITED KINGDOM<br />

N/A ZENECA LIMITED UNITED KINGDOM<br />

NIGHT NURSE ORAL SOLUTION N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM COMSUMER<br />

HEALTHCARE<br />

NIGHT NURSE CAPSULES CAPSULE N/A BEECHAM GROUP PLC<br />

T/A SMITHKLINE<br />

BEECHAM CONSUMER<br />

HEALTHCARE<br />

NIGHTTIME COLD AND FLU<br />

LIQUID CAPSULES<br />

CAPSULE N/A STANLEY<br />

PHARMACEUTICALS LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CANADA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 647<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NIMBEX SOLUTION FOR<br />

INJECTION<br />

NIMBEX SOLUTION FOR<br />

INJECTION<br />

2MG/ML THE WELLCOME<br />

FOUNDATION<br />

5MG/ML THE WELLCOME<br />

FOUNDATION<br />

NIMELID TABLETS 100MG GENEPHARM S.A. GREECE<br />

NIMOTOP FILM-COATED TABLET 30MG BAYER VITAL GMBH &<br />

CO. KG<br />

NIMOTOP INFUSION SOLUTION 0.01G/50ML BAYER VITAL GMBH &<br />

CO. KG<br />

NIMTECH TABLETS 100MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

NIPENT PWD. FOR SOL. FOR INJ/<br />

INF<br />

NIPENT POWDER FOR IV INJ.<br />

SOLN.<br />

NIPENT POWDER FOR SOLUTION<br />

FOR INJECTION/<br />

INFUSION<br />

10MG WARNER LAMBERT (UK)<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

INDIA<br />

10MG PARKE DAVIS SPA ITALY<br />

10MG CYANAMID OF GREAT<br />

BRITAIN LTD<br />

NIPIDOL 5MG TABLET TABLET 5MG BIOFARMA ILAC SAN.VE<br />

TIC.A.S<br />

NIPIDOL 5MG TABLET TABLET 5MG BIOFARMA ILLAC SAN.VE<br />

TIC.A.S.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

TURKEY<br />

TURKEY<br />

NIPODUR TABLET 150MG ANFARM HELLAS S.A. GREECE<br />

NIPOGALIN POWDER FOR INJECTION 750MG ANFARM HELLAS S.A. GREECE<br />

NISITA SALINE NASAL OINTMENT OINTMENT N/A KARL ENGELHARD GERMANY<br />

NITRAZEPAM TABLETS 5MG GLAXO WELLCOME<br />

POZNAN S.A.<br />

NITRAZEPAM BP 5MG TABLET 500MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

NITRAZEPAM TABLETS BP 5MG TABLETS 5MG CP PHARMACEUTICALS<br />

LTD.<br />

NITRAZEPAM TABLETS BP 5MG TABLET 5MG CP PHARMACEUTICALS<br />

LTD<br />

POLAND<br />

NITREDON TABLETS 5MG REMEDICA LTD. CYPRUS<br />

NITRODERM TTS TRANSDERMAL PATCHES 5MG NOVARTIS PHARMA ITALY<br />

NITRODERM TTS TRANSDERMAL PATCHES 10MG NOVARTIS FARMA SPA ITALY<br />

NITRODERM TTS 10 TRANSDERMAL PATCHES 50MG/20CM(2) NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

NITRODERM TTS 5 TRANSDERMAL PATCH 25MG/10CM(2) NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

NITROGLYCERIN INJECTION USP SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

5MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

NITROLINGUAL SPRAY SOLUTION 0.4MG/SPRAY DOS G. POHL-BOSKAMP<br />

GMBH & CO<br />

GERMANY


EN<br />

648 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NIVAQUINE TABLETS 200MG TABLET 200MG MAY & BAKER LIMITED<br />

(T/A RHONE-POULENC<br />

RORER)<br />

NIZORAL SHAMPOO 2% W/W JANSSEN-CILAG N.V. BELGIUM<br />

NIZORAL CREAM 20MG/G JANSSEN-CILAG N.V. BELGIUM<br />

NIZORAL 200MG TABLET 200MG JANSSEN-CILAG N.V. BELGIUM<br />

NIZORAL 200MG TABLET 200MG JANSSEN-CILAG N.V. BELGIUM<br />

UNITED KINGDOM<br />

NOCTAMID-1 TABLET 1MG SCHERING AG GERMANY<br />

NOCTAMIDE 1MG TABLET 1MG LABORATOIRES<br />

SCHERING<br />

FRANCE<br />

NOCTYL FILM-COATED TABLETS 15MG LABORATOIRES MONOT FRANCE<br />

NOLVADEX COATED TABLETS 10MG ZENECA LIMITED UNITED KINGDOM<br />

NOLVADEX — D COATED TABLETS 20MG ZENECA LIMITED UNITED KINGDOM<br />

NOLVADEX D (20MG TABLETS) COATED TABLET 20MG ZENECA LIMITED UNITED KINGDOM<br />

NOLVADEX TABLETS 10MG COATED TABLET 10MG ZENECA LIMITED UNITED KINGDOM<br />

NOOTROPIL FILM-COATED TABLET 800MG U.C.B. S.A. BELGIUM<br />

NOOTROPIL INTRAVENOUS INFUSION 12G/60ML U.C.B. S.A. BELGIUM<br />

NOOTROPIL INJECTABLE AMPOULE 1G/5ML U.C.B. S.A. BELGIUM<br />

NOOTROPIL 20% DRINKABLE SOLUTION 20G/100ML U.C.B. S.A. BELGIUM<br />

NOPIL SYRUP N/A MEPHA PHARMA AG SWITZERLAND<br />

NOPIL TABLETS N/A MEPHA PHARMA AG SWITZERLAND<br />

NOPIL FORTE TABLETS N/A MEPHA PHARMA AG SWITZERLAND<br />

NOPRILAM PILL N/A LABORATORIOS BIAL —<br />

PORTELA & CA, S.A.<br />

PORTUGAL<br />

NOPRILAM COATED TABLET NA LABORATORIOS BIAL PORTUGAL<br />

NOPRILAM COATED TABLETS NA LABORATOIRES BIAL PORTUGAL<br />

NOPRILAM DT COVERED PILLS N/A LABORATORIOS BIAL —<br />

PORTELA & CA, S.A.<br />

PORTUGAL<br />

NOPRILAM DT COATED TABLET NA LABORATORIOS BIAL PORTUGAL<br />

NOPRILAM DT COATED TABLETS NA LABORATOIRES BIAL PORTUGAL<br />

NOPRILAM DT 400 POWDER FOR ORAL<br />

SUSP.<br />

N/A LABORATORIOS BIAL-<br />

PORTELA & CA S.A.<br />

PORTUGAL<br />

NOPRON TABLET 250MG VIANEX S.A GREECE<br />

NORADRENALINE<br />

(NOREPINEPHRINE) 1:1000<br />

SOLUTION FOR<br />

INJECTION<br />

NORADRENALINE AGUETTANT SOLUTION FOR<br />

INFUSION<br />

0.2% W/V ABBOTT LABORATORIES<br />

LIMITED<br />

8MG/4ML LABORATOIRE<br />

AGUETTANT<br />

NORCURON 10MG POWDER FOR INJECTION 10MG/5ML ORGANON TEKNIKA B.V.<br />

(PART OF AKZO NOBEL)<br />

UNITED KINGDOM<br />

FRANCE<br />

UNITED KINGDOM<br />

NORDETTE COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 649<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NORDITRON SIMPLE XX SOLUTION FOR<br />

INJECTION<br />

5MG/1.5ML NOVO NORDISK A/S DENMARK<br />

NORDITROPIN POWDER FOR INJECTION 4IU(1.3MG)/ML NOVO NORDISK A/S DENMARK<br />

NORDITROPIN POWDER FOR INJECTION 12IU(4MG)/ML NOVO NORDISK A/S. DENMARK<br />

NORDITROPIN PENSET POWDER FOR INJECTION 12 IU (4MG)/ML NOVO NORDISK A/S DENMARK<br />

NORDITROPIN SIMPLEXX SOLUTION FOR<br />

INJECTION<br />

NORDITROPIN SIMPLEXX<br />

10MG/1.5ML<br />

NORDITROPIN SIMPLEXX<br />

5MG/1.5ML<br />

NORFLEX ORPHENADRINE<br />

CITRATE 100MG<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

10MG/1.5ML NOVO NORDISK A/S DENMARK<br />

10MG/1.5ML NOVO NORDISK A/S DENMARK<br />

5MG/1.5ML NOVO NORDISK A/S DENMARK<br />

TABLET 100MG 3M PHARMACEUTICALS<br />

PTY LTD<br />

NORGAGIL GRANULES N/A LABORATORIES<br />

NORGAN<br />

AUSTRALIA<br />

FRANCE<br />

NORGALAX UNIDOSE RECTAL GEL 0.12G NORGINE PHARMA FRANCE<br />

NORGALAX ENEMA N/A NORGINE LIMITED UNITED KINGDOM<br />

NORGESIC TABLET N/A 3M HEALTH CARE<br />

LIMITED,<br />

NORMACOL GRANULES FOR ORAL<br />

SOL.<br />

N/A LABORATOIRES<br />

NORGINE PHARMA<br />

UNITED KINGDOM<br />

FRANCE<br />

NORMACOL GRANULES 62%W/W NORGINE LIMITED UNITED KINGDOM<br />

NORMACOL INFANTS ENEMA UNIDOSE RECTAL<br />

SOLUTION<br />

NORMACOL LAVEMENT ADULTES UNIDOSE RECTAL<br />

SOLUTION<br />

NORMACOL LAVEMENT ENFANTS UNIDOSE RECTAL<br />

SOLUTION<br />

N/A LABORATOIRES<br />

NORGINE PHARMA<br />

FRANCE<br />

N/A NORGINE PHARMA FRANCE<br />

N/A NORGINE PHARMA FRANCE<br />

NORMACOL PLUS GRANULES N/A NORGINE LIMITED UNITED KINGDOM<br />

NORMACOL PLUS ORAL GRANULES N/A NORGINE LIMITED UNITED KINGDOM<br />

NORMAGLAUCON SOLUTION NA DR.GERHARD MANN,<br />

CHEM-PHARM. FABRIK<br />

GMBH<br />

NORMIX COATED TABLETS 200MG ALFA WASSERMANN<br />

S.P.A.<br />

NORMIX GRANULES FOR ORAL<br />

SUSP.<br />

2G/100ML ALFA WASSERMANN<br />

S.P.A.<br />

GERMANY<br />

NORMOLOSE TABLET 100MG ADELCO SA GREECE<br />

NORMOLOSE TABLET 50MG ADELCO SA GREECE<br />

NORMOLOSE TABLET 25MG ADELCO SA GREECE<br />

NOROXIN TABLET 400MG MERCK SHARP & DOHME PAKISTAN<br />

NOROXIN TABLET 400MG MERCK SHARP & DOHME PAKISTAN<br />

NOROXIN 400MG TABLET 400MG MERCK SHARP & DOHME<br />

B.V.<br />

ITALY<br />

ITALY<br />

NETHERLANDS


EN<br />

650 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NORTRILEN TABLET 10MG H. LUNDBECK A/S DENMARK<br />

NORTRILEN TABLET 25MG H. LUNDBECK A/S DENMARK<br />

NORTUSSINE ADULTES SYRUP N/A NORGINE PHARMA FRANCE<br />

NORTUSSINE INFANTS SYRUP N/A NORGINE PHARMA FRANCE<br />

NORVIR ORAL SOLUTION 80MG/ML ABBOTT LABORATORIES<br />

LTD.<br />

UNITED KINGDOM<br />

NORVIR SOFT-GELATIN CAPSULES 100MG ABBOTT AG SWITZERLAND<br />

NORVIR CAPSULES 100MG ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

NORVIR SOFT CAPSULES 100MG ABBOTT LABORATORIES<br />

LTD.<br />

NOSKITO GEL N/A TRIMA ISRAEL<br />

PHARMACEUTICAL<br />

PRODUCTS LIMITED<br />

NO-SPA TABLET 40MG CHINOIN<br />

PHARMACEUTICAL AND<br />

CHEMICAL WORKS CO.<br />

LTD.<br />

NO-SPA SOLUTION FOR<br />

INJECTION<br />

40MG/2ML CHINOIN<br />

PHARMACEUTICAL AND<br />

CHEMICAL WORKS CO<br />

LTD.<br />

NOTEN TABLET 50MG ALPHAPHARM PTY<br />

LIMITED<br />

NOTORIUM TABLET 1.5MG ADELCO-<br />

CHROMATOURGIA<br />

ATHINON E.<br />

COLOCOTRONIS BROS<br />

SA<br />

UNITED KINGDOM<br />

ISRAEL<br />

HUNGARY<br />

HUNGARY<br />

AUSTRALIA<br />

GREECE<br />

NOTORIUM TABLET 3MG ADELCO SA GREECE<br />

NOTORIUM TABLET 6MG ADELCO SA GREECE<br />

NOVACLAV 375 TABLETS TABLETS NA CIPLA LTD. INDIA<br />

NOVAGESIC-FLU 20 CAPSULE N/A SCANPHARM A.S. JAMAICA<br />

NOVAL EYE DROPS SOLUTION 0.5% W/V DEMO ABEE GREECE<br />

NOVAL EYE DROPS SOLUTION 0.25% W/V DEMO ABEE GREECE<br />

NOVALGINE 500MG COATED TABLET 500MG LABORATOIRE HOECHST FRANCE<br />

NOVAMILOR TAB TABLETS N/A NOVOPHARM LTD CANADA<br />

NOVAMOXIN CAP 250MG CAPSULES 250MG NOVOPHARM LTD CANADA<br />

NOVAMOXIN SUS 125MG/5ML POWDER FOR SOLUTION 125MG/5ML NOVOPHARM LIMITED CANADA<br />

NOVAMOXIN SUS 250MG/5ML POWDER FOR SOLUTION 250MG/5ML NOVOPHARM LIMITED CANADA<br />

NOVANTRONE SOLUTION FOR<br />

INJECTION<br />

NOVANTRONE SOLUTION FOR IV<br />

INFUSION<br />

20MG/10ML JOHN WYETH &<br />

BROTHER LTD.<br />

20MG/10ML CYANAMID OF GREAT<br />

BRITAIN LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 651<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NOVANTRONE INJECTION SOLUTION FOR<br />

INJECTION/INFUSION<br />

2MG/2ML CYANAMID OF GREAT<br />

BRITAIN LTD<br />

NOVATAX-1000 POWDER FOR INJECTION 1G CIPLA LTD INDIA<br />

UNITED KINGDOM<br />

NOVESIN 0.4% EYE DROPS 0.4% W/V CIBA VISION AG SWITZERLAND<br />

NOVESIN 0.4% EYE DROPS 4.00MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

SWITZERLAND<br />

NOVOAMOXIN CAP 500MG CAPSULES 500MG NOVOPHARM LTD CANADA<br />

NOVO-AMPICILLIN CAPSULE 500MG NOVOPHARM LIMITED CANADA<br />

NOVO-ATENOL TAB 100MG TABLET 100MG NOVOPHARM LIMITED CANADA<br />

NOVO-ATENOL TAB 50MG TABLET 50MG NOVOPHARM LIMITED CANADA<br />

NOVO-AZT CAP 100MG CAPSULE 100MG NOVOPHARM LIMITED CANADA<br />

NOVOBAN CAPSULE 5MG NOVARTIS SVERIGE AB SWEDEN<br />

NOVOBAN SOLUTION FOR<br />

INJECTION<br />

1MG/1ML NOVARTIS SVERIGE AB SWEDEN<br />

NOVO-BROMAZEPAM TABLET 6MG NOVOPHARM LIMITED CANADA<br />

NOVO-BROMAZEPAM TAB 3MG TABLET 3MG NOVOPHARM LIMITED CANADA<br />

NOVO-BUSPIRONE TAB 10MG TABLET 10MG NOVOPHARM LIMITED CANADA<br />

NOVO-CAPTORIL TABLET 25MG NOVOPHARM LIMITED CANADA<br />

NOVO-CAPTORIL TABLET 50MG NOVOPHARM LIMITED CANADA<br />

NOVO-CEFACLOR CAPSULE 500MG NOVOPHARM LIMITED CANADA<br />

NOVO-CEFACLOR CAP 250MG CAPSULE 250MG NOVOPHARM LIMITED CANADA<br />

NOVO-CHLOROCAP CAP 250MG CAPSULES 250MG NOVOPHARM LTD CANADA<br />

NOVO-CHOLAMINE — PWR POWDER FOR ORAL<br />

SUSP.<br />

NOVO-CLOPAMINE TABLETS —<br />

10MG<br />

NOVO-CLOPAMINE TABLETS —<br />

25MG<br />

4G NOVOPHARM LTD CANADA<br />

TABLETS 10MG NOVOPHARM LTD CANADA<br />

TABLETS 25MG NOVOPHARM LIMITED CANADA<br />

NOVO-DIFENAC SUPPOSITORY 100MG NOVOPHARM LIMITED CANADA<br />

NOVO-DIFENAC ENTERIC COATED<br />

TABLET<br />

50MG NOVOPHARM LIMITED CANADA<br />

NOVO-DILTAZEM TAB 60MG TABLETS 60MG NOVOPHARM LTD CANADA<br />

NOVO-DIPAM TABLET 5MG NOVOPHARM LIMITED CANADA<br />

NOVO-DIPAM TABLET 2MG NOVOPHARM LIMITED CANADA<br />

NOVO-DIPIRADOL TABLET 25MG NOVOPHARM LIMITED CANADA<br />

NOVO-DOMPERIDONE TABLET 10MG NOVOPHARM LIMITED CANADA<br />

NOVO-DOXEPIN CAP 25MG CAPSULES 25MG NOVOPHARM LTD CANADA<br />

NOVO-DOXYLIN CAPSULE 100MG NOVOPHARM LIMITED CANADA<br />

NOVO-FAMOTIDINE TABLET 20MG NOVOPHARM LIMITED CANADA


EN<br />

652 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NOVOFEM TABLETS NA NOVO NORDISK A/S DENMARK<br />

NOVO-FLUPAM CAP 15MG CAPSULES 15MG NOVOPHARM LIMITED CANADA<br />

NOVO-FLUPAM CAP 30MG CAPSULE 30MG NOVOPHARM LTD CANADA<br />

NOVO-FLUVOXAMINE TABLET 50MG NOVOPHARM LIMITED CANADA<br />

NOVO-FLUXOETINE CAPSULE 20MG NOVOPHARM LIMITED CANADA<br />

NOVO-FOLIACID 5MG TABLETS 5MG NOVOPHARM LTD CANADA<br />

NOVO-GLICLAZIDE TABLET 80MG NOVOPHARM LIMITED CANADA<br />

NOVO-GLYBURIDE TABLETS 5MG NOVOPHARM LIMITED CANADA<br />

NOVO-HEXIDYL 2MG TABLET 2MG NOVOPHARM LIMITED CANADA<br />

NOVO-HYDROCORT CRM 1% CREAM 1% W / W NOVOPHARM LTD CANADA<br />

NOVO-HYDROXYZIN CAPSULE 25MG NOVOPHARM LIMITED CANADA<br />

NOVO-HYLAZIN TABLET 25MG NOVOPHARM LIMITED CANADA<br />

NOVO-HYLAZIN 10MG USP TABLET 10MG NOVOPHARM LIMITED CANADA<br />

NOVO-INDAPAMIDE TABLET 2.5MG NOVOPHARM LIMITED CANADA<br />

NOVO-KETOTIFEN SYRUP 1MG/5ML NOVOPHARM LIMITED CANADA<br />

NOVO-LEXIN CAP 250MG CAPSULES 250MG NOVOPHARM LTD CANADA<br />

NOVO-LORAZEM TABLET 1MG NOVOPHARM LIMITED CANADA<br />

NOVO-LORAZEM TABLET 2MG NOVOPHARM LIMITED CANADA<br />

NOVO-MAPROTILINE TABLET 25MG NOVOPHARM LIMITED CANADA<br />

NOVO-MAPROTILINE TABLET 10MG NOVOPHARM LIMITED CANADA<br />

NOVO-MAPROTILINE — TAB<br />

50MG<br />

TABLETS 50MG NOVOPHARM LTD CANADA<br />

NOVO-METFORMIN TABLET 850MG NOVOPHARM LIMITED CANADA<br />

NOVO-MEXILETINE CAPSULES 200MG NOVOPHARM LTD CANADA<br />

NOVOMIX 30 FLEXPEN SUSPENSION FOR<br />

INJECTION IN A<br />

PRE-FILLED PEN<br />

NOVOMIX 30 PENFILL SUSPENSION FOR<br />

INJECTION IN<br />

CARTRIDGES<br />

100U/ML NOVO NORDISK A/S EUROPEAN COMMUNITY<br />

100U/ML NOVO NORDISK A/S EUROPEAN COMMUNITY<br />

NOVO-MOCLOBEMIDE TABLET 150MG NOVOPHARM LIMITED CANADA<br />

NOVO-NADOLOL TABLET 40MG NOVOPHARM LIMITED CANADA<br />

NOVO-NAPROX TAB 250MG TABLETS 250MG NOVOPHARM LTD CANADA<br />

NOVO-NIFEDIN CAP 10MG CAPSULES 10MG NOVOPHARM LTD CANADA<br />

NOVO-NORFLOXACIN TABLET 400MG NOVOPHARM LIMITED CANADA<br />

NOVONORM TABLET 0.5MG NOVO NORDISK A/S UNITED KINGDOM<br />

NOVONORM TABLET 1MG NOVO NORDISK A/S UNITED KINGDOM<br />

NOVONORM TABLET 2MG NOVO NORDISK A/S UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 653<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NOVO-PERIDOL TABLET 5MG NOVOPHARM LIMITED CANADA<br />

NOVO-PHENYTOIN CAPSULE 100MG NOVOPHARM LIMITED CANADA<br />

NOVO-PRAMINE TABLET 10MG NOVOPHARM LIMITED CANADA<br />

NOVO-PRAMINE TABLET 25MG NOVOPHARM LIMITED CANADA<br />

NOVO-PRANOL TABLET 40MG NOVOPHARM LIMITED CANADA<br />

NOVO-PRANOL TABLET 10MG NOVOPHARM LIMITED CANADA<br />

NOVO-PRAZIN TABLET 1MG NOVOPHARM LIMITED CANADA<br />

NOVO-PREDNISONE 5MG TABLETS 5MG NOVOPHARM LTD CANADA<br />

NOVO-QUINIDIN 200MG TABLETS 200MG NOVOPHARM LTD CANADA<br />

NOVO-RANIDINE TAB 150MG TABLETS 150MG NOVOPHARM LTD CANADA<br />

NOVORAPID 100UNITS/ML SOLUTION FOR<br />

INJECTION<br />

NOVORAPID NOVOLET<br />

100UNITS/ML<br />

NOVORAPID PENFILL<br />

100UNITS/ML<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

100UNITS/ML NOVO NORDISK A/S UNITED KINGDOM<br />

100UNITS/ML NOVO NORDISK A/S UNITED KINGDOM<br />

100UNITS/ML NOVO NORDISK A/S UNITED KINGDOM<br />

NOVO-RIDAZINE 25MG TABLETS 25MG NOVOPHARM LTD CANADA<br />

NOVOSEVEN POWDER FOR INJECTION 60KIU (1.2MG) NOVO NORDISK A/S UNITED KINGDOM<br />

NOVOSEVEN POWDER FOR INJECTION 120KIU (2.4MG) EU/1/96/006/002 DENMARK<br />

NOVOSEVEN POWDER FOR INJECTION 240KIU (4.8MG) NOVO NORDISK A/S DENMARK<br />

NOVO-SOTALOL TABLET 80MG NOVOPHARM LIMITED CANADA<br />

NOVO-SPIROTON TABLET 25MG NOVOPHARM LIMITED CANADA<br />

NOVO-SUNDAC TAB 200MG TABLETS 200MG NOVOPHARM LTD CANADA<br />

NOVO-TETRA 250MG CAPSULES 250MG NOVOPHARM LTD CANADA<br />

NOVO-TRIFLUZINE TABLET 5MG NOVOPHARM LIMITED CANADA<br />

NOVO-TRIPRAMINE TAB 25MG BP TABLET 25MG NOVOPHARM LIMITED CANADA<br />

NOVO-TRIPRAMINE TAB 50MG TABLETS 50MG NOVOPHARM LTD CANADA<br />

NOVO-TRIPTYN TABLET 10MG NOVOPHARM LIMITED CANADA<br />

NOVO-TRIPTYN TAB 25MG TABLETS 25MG NOVOPHARM LTD CANADA<br />

NUBAIN SOLUTION FOR<br />

INJECTION<br />

NUBAIN SOLUTION FOR<br />

INJECTION<br />

NUELIN SA 175MG TABLETS MODIFIED RELEASE<br />

TABLET<br />

NUELIN SA 250MG TABLETS MODIFIED RELEASE<br />

TABLET<br />

10MG/ML ENDO<br />

PHARMACEUTICALS INC.<br />

20MG/ML ENDO<br />

PHARMACEUTICALS INC<br />

175MG 3M HEALTH CARE<br />

LIMITED<br />

250MG 3M HEALTH CARE<br />

LIMITED<br />

NUELIN TABLETS TABLET 125MG 3M HEALTH CARE<br />

LIMITED<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

654 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NU-LAX FRUIT LAXATIVE SENNA<br />

LEAF<br />

NUMARK ANTI-DIARRHOEA<br />

CAPSULES<br />

BLOCK 80MG/G ORCHARD<br />

MANUFACTURING CO.<br />

PTY LTD<br />

CAPSULES 2MG GALPHARM<br />

HEALTHCARE LIMITED —<br />

UK<br />

NUMARK CHESTY COUGH ORAL LIQUID 100MG/5ML BELL SONS & CO<br />

(DRUGGISTS) LIMITED<br />

NUMARK CHESTY COUGH<br />

EXPECTORANT<br />

NUMARK CHILDREN CHESTY<br />

COUGH LINCTUS<br />

NUMARK DECONGESTANT<br />

TABLETS WITH PARACETAMOL<br />

SYRUP N/A BELL SONS & CO<br />

(DRUGGISTS) LIMITED<br />

ORAL SOLUTION N/A ROSEMONT<br />

PHARMACEUTICALS<br />

LIMITED<br />

FILM COATED TABLETS NA DEXCEL-PHARMA<br />

LIMITED<br />

AUSTRALIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NUMARK NIGHT TIME SLEEP AID COATED TABLET 25MG NORMA CHEMICALS UNITED KINGDOM<br />

NUPERCAINAL OINTMENT 1.1%W/W EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

NUROFEN COATED TABLET 200MG CROOKES HEALTHCARE<br />

LIMITED<br />

NUROFEN 400 COATED TABLET 400MG CROOKES HEALTHCARE<br />

LIMITED<br />

NUROFEN COLD AND FLU COATED TABLET N/A CROOKES HEALTHCARE<br />

LIMITED<br />

NUROFEN FOR CHILDREN SUGAR<br />

FREE<br />

ORAL SUSPENSION 100MG/5ML CROOKES HEALTHCARE<br />

LIMITED<br />

NUROFEN PLUS COATED TABLET N/A CROOKES HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NURSE HARVEY'S GRIPE MIXTURE ORAL SOLUTION N/A HARVEY SCRUTON LTD UNITED KINGDOM<br />

NURSE SYKES POWDERS ORAL POWDER N/A ANGLIAN PHARMA PLC UNITED KINGDOM<br />

NUSEALS TABLET 75MG LILLY PAKISTAN<br />

NU-SEALS 300 GASTRO-RESISTANT<br />

TABLET<br />

300MG ELI LILLY & COMPANY<br />

LIMITED<br />

NU-SEALS 75 COATED TABLET 75MG ELI LILLY & COMPANY<br />

LIMITED<br />

NUTRAMID TABLETS 10MG THE ACME<br />

LABORATORIES LTD —<br />

BANGLADESH<br />

NUTRINEAL PD4 PERIT. DIALYSIS<br />

SOL.<br />

SOL F/INTRAPERITONEAL<br />

ADM<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

NUVELLE CONTINUOUS COATED TABLET N/A SCHERING HEALTH CARE<br />

LTD<br />

NUVELLE TABLETS COATED TABLET N/A SCHERING HEALTH CARE<br />

LTD<br />

NUVELLE TS TRANSDERMAL PATCH N/A ETHICAL<br />

PHARMACEUTICALS (UK)<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

BANGLADESH<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 655<br />

Trade Name Dosage Form Dose MA Holder Country<br />

NUVELLE TS TRANSDERMAL PATCH N/A SCHERING HEALTH CARE<br />

LTD<br />

NYADERM CRM 100000 UNIT/GM CREAM 100000 UNIT TARO<br />

PHARMACEUTICALS INC.<br />

NYLAX WITH SENNA TABLET 7.5MG CROOKES HEALTHCARE<br />

LIMITED<br />

NYLOL OPHTHALMIC GEL 1.00MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

NYOLOL 0.25% EYE DROPS 0.0125G/5ML CIBA VISION<br />

OPHTHALMICS<br />

NYOLOL 0.5% EYE DROPS 0.5% W/V CIBA VISION<br />

OPHTHALMICS<br />

NYOLOL 0.5% EYE DROPS 0.5MG/ML NOVARTIS<br />

OPHTHALMICS SA<br />

UNITED KINGDOM<br />

CANADA<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

NYOLOL GEL OPHTHALMIC GEL 1MG/G CIBA VISION AG SWITZERLAND<br />

NYSTATIN TABLETS 500,000UNITS TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD.<br />

NYSTATIN READY MIX<br />

SUSPENSION<br />

SUSPENSION 100,000U/ML TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD.<br />

NYSTATIN TABLETS TABLET 500,000 UNITS TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

NYSTATIN, READY MIX<br />

SUSPENSION<br />

SUSPENSION 100,000 U/ML TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

NYTOL TABLET 25MG STAFFORD-MILLER<br />

LIMITED<br />

NYTOL ONE-A-NIGHT TABLET 50 MG STAFFORD-MILLER<br />

LIMITED<br />

NYTOL ONE-A-NIGHT TABLET 50MG STAFFORD MILLER<br />

LIMITED<br />

NYTOL TABLETS TABLET 25MG STAFFORD MILLER<br />

LIMITED<br />

OCATANATE 500 POWDER AND SOLVENT<br />

FOR SOL.<br />

OCTAGRAM SOLUTION FOR<br />

INFUSION<br />

OCTANATE 1000 POWDER AND SOLVENT<br />

FOR SOL.<br />

OCTANATE 250 POWDER AND SOLVENT<br />

FOR SOL.<br />

500 I.U./VIAL OCTAPHARMA VERTRIEB<br />

VON PLASMADERIVATEN<br />

GMBH<br />

50MG/ML OCTAPHARMA<br />

PHARMAZEUTIKA<br />

PRODUKTIONSGES.M.B.H.<br />

1000 I.U./VIAL OCTAPHARMA VERTRIEB<br />

VON PLASMADERIVATEN<br />

GMBH<br />

250 I.U./VIAL OCTAPHARMA VERTRIEB<br />

VON PLASMADERIVATEN<br />

GMBH<br />

ISRAEL<br />

ISRAEL<br />

ISRAEL<br />

ISRAEL<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

AUSTRIA<br />

GERMANY<br />

GERMANY<br />

OCTOFENE 100MG SUPPOSITORY 100MG LABORATOIRES DEBAT FRANCE<br />

OCTOFENE 200MG SUPPOSITORY 200MG LABORATOIRES DEBAT FRANCE<br />

OCTOFENE 750MG SUPPOSITORY 750MG LABORATOIRES DEBAT FRANCE


EN<br />

656 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

OCTONATIV-M POWDER FOR INJECTION 1000IU(I+II) PHARMACIA & UPJOHN<br />

AB<br />

OCTONATIV-M POWDER FOR INJECTION 250IU(I+II) PHARMACIA & UPJOHN<br />

AB<br />

OCTONATIV-M POWDER FOR INJECTION 500IU PHARMACIA & UPJOHN<br />

AB<br />

SWEDEN<br />

SWEDEN<br />

SWEDEN<br />

OCTONATIV-M POWDER AND SOLVENT 500 IU BIOVITRUM AB SWEDEN<br />

OCTONATIV-M 1000IU POWDER AND SOLVENT (I+11) 1000IU BIOVITRUM AB SWEDEN<br />

OCTORAX TABLETS 20MG DEM ABEE GREECE<br />

OCTOSTIM SOLUTION FOR<br />

INJECTION<br />

15MCG/ML FERRING AB SWEDEN<br />

OCUBRAX EYE DROPS N/A ALCON CUSI S.A. SPAIN<br />

OCULOSAN EYE DROPS N/A CIBA VISION AG SWITZERLAND<br />

OCULOSAN EYE DROPS NA NOVARTIS<br />

OPHTHALMICS AG<br />

SWITZERLAND<br />

OCULOTECT EYE GEL 1000IU/G CIBA VISION AG SWITZERLAND<br />

OCULOTECT EYE GEL 1000 UI /1G NOVARTIS<br />

OPHTHALMICS AG<br />

OCULOTECT FLUID EYE DROPS 0.5G/10ML CIBA VISION<br />

OPHTHALMICS<br />

OCUTIM EYE DROPS SOLUTION 0.25% W/W CIPLA LIMITED INDIA<br />

OCUTIM 0.5% EYE DROPS 0.5% W/V CIPLA LIMITED INDIA<br />

SWITZERLAND<br />

FRANCE<br />

ODASOL/GENEPHARM E.C. CAPSULES 20MG GENEPHARM S.A. GREECE<br />

OESTRADIOL IMPLANT IMPLANT (SUB-CUTAN.<br />

USE)<br />

OESTRADIOL IMPLANT IMPLANT (SUB-CUTAN.<br />

USE)<br />

25MG ORGANON<br />

LABORATORIES LIMITED<br />

50MG ORGANON<br />

LABORATORIES LIMITED<br />

OESTRING VAGINAL DEVICE 7.5MCG/24HOURS PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

OESTRODOSE 0.06% GEL FOR<br />

PERCUTANEOUS APPL<br />

0.06% W/W LABORATOIRES BESINS-<br />

ISCOVESCO<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWEDEN<br />

FRANCE<br />

OESTROFEMINAL 0.3MG CAPSULES 0.3MG HEINRICH MACK NACHF GERMANY<br />

OESTROFEMINAL 0.6MG CAPSULES 0.6MG HEINRICH MACK NACHF GERMANY<br />

OESTROFEMINAL 1.25MG CAPSULES 1.25MG HEINRICH MACK NACHF GERMANY<br />

OFLOCET EAR DROPS 1.5MG/0.5ML LABORATOIRES AVENTIS FRANCE<br />

OFLOCET 200MG TABLET 200MG LABORATOIRES AVENTIS FRANCE<br />

OFLOCET 200MG/40ML SOLUTION FOR<br />

INFUSION<br />

200MG/40ML LABORATOIRES<br />

DIAMANT<br />

OFLOMAC-100 TABLETS 100MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

OFLOMAC-200 TABLET 200MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

FRANCE<br />

INDIA<br />

INDIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 657<br />

Trade Name Dosage Form Dose MA Holder Country<br />

OFLOMAC-300 TABLETS 300MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

OFLOMAC-400 TABLET 400MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

OFLOX 0.3% OPHTHALMIC SOLUTION 0.3% W/V ALLERGAN<br />

PHARMACEUTICALS<br />

(IRELAND) LTD., INC.<br />

OFTALMIL EYE WASH N/A BRUSCHETTINI SRL ITALY<br />

OFTALMIL EYE DROPS, SOLUTION N/A BRUSCHETTINI SRL ITALY<br />

OILATUM SOAP 7.5% W/W STIEFEL LABORATORIES<br />

(UK) LTD<br />

OILATUM CREAM CREAM NA STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

OILATUM EMOLLIENT TOPICAL SOLUTION 63.4% W/W STIEFEL LABORATORIES<br />

(UK) LTD<br />

OILATUM GEL TOPICAL SOLUTION 70% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

OILATUM JUNIOR TOPICAL SOLUTION 63.4% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

OILATUM JUNIOR FLARE-UP TOPICAL SOLUTION N/A STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

OILATUM PLUS TOPICAL SOLUTION N/A STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

OILY CREAM BP CREAM NO ACTIVE ING. ADAMS HEALTHCARE<br />

LIMITED<br />

OILY PHENOL INJECTION 5% W/V SOLUTION FOR<br />

INJECTION<br />

5%W/V MACARTHYS<br />

LABORATORIES LTD<br />

OKA-AZITHROMYCIN TABLETS 250MG OKASA PHARMA PTV<br />

LTD.<br />

INDIA<br />

INDIA<br />

IRELAND<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

OKACIN EYE DROPS 3MG/ML CIBA VISION AG SWITZERLAND<br />

OKACIN EYE DROPS NA NOVARTIS<br />

OPHTHALMICS AG<br />

OKA-OMEPRAZOLE CAPSULES CAPSULE 20MG OKASA PHARMA PVT.<br />

LTD -INDIA<br />

OKAVIR TABLETS 150MG OKASA PHARMA LTD-<br />

INDIA<br />

OKI SOLUTION FOR ORAL<br />

MUCOSA<br />

OLBAS BLACKCURRANT<br />

PASTILLES<br />

INDIA<br />

SWITZERLAND<br />

INDIA<br />

INDIA<br />

N/A DOMPE' SPA ITALY<br />

LOZENGE NA GR LANE HEALTH<br />

PRODUCTS LIMITED<br />

OLBAS INHALER INHALATION LIQUID NA GR LANE HEALTH<br />

PRODUCTS<br />

OLBAS OIL TOPICAL SOLUTION N/A G R LANE HEALTH<br />

PRODUCTS<br />

OLBAS PASTILLES LOZENGE N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

OLBETAM CAPSULES 250MG PHARMACIA & UPJOHN<br />

S.P.A.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY


EN<br />

658 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

OLFEN GEL 10MG/G MEPHA PHARMA AG SWITZERLAND<br />

OLFEN ROLL-ON GEL 10MG/1G MEPHA PHARMA AG SWITZERLAND<br />

OLFEN-100 RECTOCAPS 100MG MEPHA PHARMA AG SWITZERLAND<br />

OLFEN-100 SR DEPOCAPS 100MG MEPHA PHARMA AG SWITZERLAND<br />

OLFEN-25 LACTABS 25MG MEPHA PHARMA AG SWITZERLAND<br />

OLFEN-50 LACTABS 50MG MEPHA PHARMA AG SWITZERLAND<br />

OLFEN-75 SOLUTION FOR<br />

INJECTION<br />

N/A MEPHA PHARMA AG SWITZERLAND<br />

OLFEN-75 RETARD DEPOTABS 75MG MEPHA PHARMA AG SWITZERLAND<br />

OMEDAR TABLETS TABLETS 21 MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD.<br />

OMEDOR ENTERIC COATED<br />

TABLETS<br />

OMNIC 0.4 MODIFIED RELEASE<br />

CAPSULES<br />

OMNIPAQUE SOLUTION FOR<br />

INJECTION<br />

OMNIPAQUE SOLUTION FOR<br />

INJECTION<br />

OMNIPAQUE SOLUTION FOR<br />

INJECTIONS<br />

OMNIPAQUE SOLUTION FOR<br />

INJECTION<br />

OMNIPAQUE SOLUTION FOR<br />

INJECTION<br />

OMNIPAQUE SOLUTION FOR<br />

INJECTIONS<br />

OMNIPAQUE SOLUTION FOR<br />

INJECTION<br />

OMNIPAQUE SOLUTION FOR<br />

INJECTIONS<br />

OMNIPAQUE SOLUTION FOR<br />

INJECTIONS<br />

OMNIPAQUE SOLUTION FOR<br />

INJECTION<br />

OMNIPAQUE SOLUTION FOR<br />

INJECTION<br />

OMNISCAN SOLUTION FOR<br />

INJECTION<br />

OMNISCAN SOLUTION FOR<br />

INJECTION<br />

OMNISCAN SOLUTION FOR<br />

INJECTION<br />

OMNISCAN SOLUTION FOR<br />

INJECTION<br />

20MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

0.4MG YAMANOUCHI PHARMA<br />

B.V.<br />

JORDAN<br />

JORDAN<br />

NETHERLANDS<br />

180MG I/ML NYCOMED UK LIMITED UNITED KINGDOM<br />

240MG I/ML NYCOMED U.K. LIMITED NORWAY<br />

300MG I/ML NYCOMED U.K. LIMITED NORWAY<br />

350MG I/ML NYCOMED U.K. LIMITED NORWAY<br />

140MG I/ML NYCOMED IMAGING AS NORWAY<br />

180MG I/ML NYCOMED IMAGING AS NORWAY<br />

240MG I/ML NYCOMED IMAGING AS NORWAY<br />

300MG I/ML NYCOMED IMAGING AS NORWAY<br />

350MG I/ML NYCOMED IMAGING AS NORWAY<br />

SEE REMARKS AMERSHAM HEALTH AS NORWAY<br />

SEE REMARKS AMERSHAM HEALTH AS NORWAY<br />

N/A NYCOMED IMAGING AS NORWAY<br />

287MG/1ML NYCOMED IMAGING AS NORWAY<br />

0.5 MMOL/ML AMERSHAM HEALTH AS NORWAY<br />

0.5MMOL/ML AMERSHAM HEALTH AS NORWAY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 659<br />

Trade Name Dosage Form Dose MA Holder Country<br />

OMP TABLET (OMEPRAZOLE) TABLET 20MG CHONG KUN DANG<br />

PHARMACEUTICAL<br />

CORP.<br />

ONCASPAR SOLUTION FOR<br />

INJECTION<br />

ONCOVIN SOLUTION FOR<br />

INJECTION<br />

750 IU/ML MEDAC GESELLSCHAFT<br />

FUR KLINISCHE<br />

SPEZIALPRAPARATE MBH<br />

1MG/ML LABORATOIRES LILLY<br />

FRANCE<br />

KOREA (DEM PEOPLE'S<br />

REP)<br />

GERMANY<br />

FRANCE<br />

ONCTOSE HYDROCORTISONE CREAM N/A LABORATOIRES MONOT FRANCE<br />

ONE ALPHA CAPSULE CAPSULE 0.25MCG LEO PAKISTAN<br />

ONE-ALPHA CAPSULES 0.5MCG LEO PHARMACEUTICAL<br />

PRODUCTS<br />

ONE-ALPHA CAPSULES 0.25MCG LEO PHARMACEUTICAL<br />

PRODUCTS<br />

ONE-ALPHA CAPSULES 1MCG LEO PHARMACEUTICAL<br />

PRODUCTS<br />

ONE-ALPHA DROPS 2MCG/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

ONE-ALPHA SOLUTION FOR<br />

INJECTION<br />

2MCG/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

DENMARK<br />

DENMARK<br />

DENMARK<br />

DENMARK<br />

DENMARK<br />

ONE-ALPHA CAPSULES CAPSULES 1MCG LEO PAKISTAN<br />

ONKOVERTIN 40 IN 0.9%W/V<br />

SODIUM CHLORIDE<br />

ONKOVERTIN 40 IN 5% W/V<br />

GLUCOSE<br />

ONKOVERTIN 70 IN 0.9%W/V<br />

SODIUM CHLORIDE<br />

INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

OPHTAMOLOL EYE DROPS 0.25% W/V DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

OPHTAMOLOL EYE DROPS 0.5% DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

OPRAZOLE TABLETS (14) 20MG HIKMA<br />

PHARMACEUTICALS<br />

OPTAMID OPHTHALMIC DROPS NA PROGE FARMA SRL ITALY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

JORDAN<br />

JORDAN<br />

JORDAN<br />

OPTICROM AQUEOUS EYE DROPS EYE DROPS 2% W/V FISONS LIMITED UNITED KINGDOM<br />

OPTICROM AQUEOUS EYE DROPS EYE DROPS 2%W/V FISONS LTD UNITED KINGDOM<br />

OPTICROM EYE OINT. OR<br />

VISICROM EYE OINT.<br />

OPTICROM EYE<br />

OINTMENT/VISICROM<br />

OPTICROM-UD EYE DROPS IN<br />

AMPOULES<br />

OPTICROM-UD EYE DROPS IN<br />

AMPOULES<br />

EYE OINTMENT 4% W/V FISONS LIMITED UNITED KINGDOM<br />

EYE OINTMENT 4%W/W FISONS LTD T/A RHONE-<br />

POULENC RORER<br />

20MG/ML RHONE-POULENC RORER<br />

AG<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

N/A H. LUNBECK A/S DENMARK<br />

OPTILAST EYE DROPS 0.05% W/V ASTA MEDICA LTD UNITED KINGDOM


EN<br />

660 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

OPTIPAX EAR DROPS SOLUTION N/A BIOCODEX<br />

LABORATORIES<br />

FRANCE<br />

OPTREX EYE DROPS EYE DROPS 13%V/V OPTREX LIMITED UNITED KINGDOM<br />

OPTREX EYE LOTION EYE LOTION 13%V/V OPTREX LIMITED UNITED KINGDOM<br />

OPTREX MEDICATED EYE DROPS EYE DROPS N/A OPTREX LIMITED UNITED KINGDOM<br />

ORACORT PASTE PASTE 0.10% W/W TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

ORAL POLIO VACCINE —<br />

TRIVALENT<br />

SOLUTION FOR ORAL<br />

ADMI.<br />

ISRAEL<br />

N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

ORAL POLIOMYELITIS VACCINE DRINKABLE SOLUTION NA AVENTIS PASTEUR S.A. FRANCE<br />

ORAL POLIOMYELITIS VACCINE<br />

POLIO SABIN<br />

SUSP. FOR ORAL<br />

ADMINIST.<br />

N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

ORALDENE SOLUTION 5MG/5ML WARNER LAMBERT<br />

CONSUMER<br />

HEALTHCARE<br />

ORAMORPH ORAL SOLUTION 10MG/5ML BOEHRINGER INGELHEIM<br />

LTD<br />

BELGIUM<br />

ORAP 1MG TABLET 1MG JANSSEN-CILAG N.V. BELGIUM<br />

ORAP FORTE TABLET 4MG JANSSEN-CILAG N.V. BELGIUM<br />

ORAP FORTE TABLETS 4MG JANSSEN CILAG NV BELGIUM<br />

ORELOX 100MG TABLET 100MG LABORATOIRES AVENTIS FRANCE<br />

ORELOX 40MG/5ML ENFANT ET<br />

NOURRISSON<br />

GRANULES FOR ORAL<br />

SUSPEN.<br />

40MG/5ML LABORATOIRES AVENTIS FRANCE<br />

ORFENAL 50 TABLETS 50MG REMEDICA LTD CYPRUS<br />

ORIGINAL ANDREWS SALT EFFERVESCENT POWDER N/A SMITHKLINE BEECHAM<br />

(SWG) LIMITED<br />

ORIGINAL PHENSIC ASPIRIN TABLET N/A SEVEN SEAS LIMITED T/A<br />

MERCK CONSUMER<br />

HEALTH<br />

ORIMETEN TABLETS 250MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

ORIMETEN TABLETS 250MG NOVARTIS FARMA SPA ITALY<br />

ORLEPT TABLETS 200MG CP PHARMACEUTICALS<br />

LTD.<br />

OROCHOL BERNA DOUBLE<br />

SACHET<br />

LYOPHILISED VACC. FOR<br />

REC<br />

N/A SWISS SERUM AND<br />

VACCINE INSTITUTE<br />

OROFAR WITH LIDOCAIN LOZENGES N/A NOVARTIS CONSUMER<br />

HEALTH SA<br />

OROFAR WITH LIDOCAIN SOLUTION N/A NOVARTIS CONSUMER<br />

HEALTH SA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

OROPRAM 10 MG, TABLETS TABLETS 10 MG OMEGA FARMA EHF. ICELAND<br />

OROPRAM 20 MG, TABLETS TABLETS 20 MG OMEGA FARMA EHF. ICELAND<br />

OROPRAM 40 MG, TABLETS TABLETS 40 MG OMEGA FARMA EHF. ICELAND


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 661<br />

Trade Name Dosage Form Dose MA Holder Country<br />

OROVITE 7 GRANULES FOR ORAL<br />

SUSP.<br />

OROVITE 7 GRANULES FOR ORAL<br />

SUSP.<br />

N/A SETON HEALTHCARE<br />

GROUP PLC<br />

N/A SETON PRODUCTS<br />

LIMITED<br />

OROVITE TABLETS TABLET N/A SETON HEALTHCARE<br />

GROUP PLC<br />

OROVITE TABLETS TABLETS N/A SETON PRODUCTS<br />

LIMITED<br />

ORREPASTE PASTE N/A HOE PHARMACEUTICALS<br />

SDN.BHD.<br />

ORREPASTE, CREAM CREAM 0.1% W/W HOE PHARMACEUTICALS<br />

SDN. BHD<br />

ORSINON TABLET 500MG REKAH<br />

PHARMACEUTICAL<br />

INDUSTRY LTD<br />

ORTHOCLONE OKT 3 SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

MALAYSIA<br />

ISRAEL<br />

5MG/5ML JANSSEN-CILAG AG SWITZERLAND<br />

ORTHO-GYNEST VAGINAL CREAM 0.1MG/G JANSSEN-CILAG AG SWITZERLAND<br />

ORTHO-GYNEST VAGINAL OVULE 0.5MG JANSSEN-CILAG AG SWITZERLAND<br />

ORUVAIL 100 MODIFIED RELEASE<br />

CAPSULE<br />

ORUVAIL 200 MODIFIED RELEASE<br />

CAPSULE<br />

100MG HAWGREEN LIMITED IRELAND<br />

200MG HAWGREEN LIMITED IRELAND<br />

OSANGIN TABLETS N/A MARCO ANTONETTO<br />

SPA<br />

OSMOFUNDIN 10% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

OSMOFUNDIN 15% N INFUSION SOLUTION 15% W/V B.BRAUN MELSUNGEN<br />

AG<br />

ITALY<br />

GERMANY<br />

GERMANY<br />

OSMOFUNDIN 15% N INFUSION SOLUTION 15% W/V B.BRAUN MELSNGEN AG GERMANY<br />

OSMOGEL GEL F/LOCAL<br />

APPLICATION<br />

N/A LABORATOIRES MONOT FRANCE<br />

OSPAMOX TABLET 500MG BIOCHEMIE GMBH AUSTRIA<br />

OSPEXIN TABLET 500MG BIOCHEMIE GMBH AUSTRIA<br />

OSSIN RETARDDRAGEES TABLET 40MG GRUNENTHAL GMBH GERMANY<br />

OSTEDRON CAPSULES 400MG KLEVA LIMITED GREECE<br />

OSTEOCALCIN SOLUTION FOR<br />

INJECTION<br />

100 IU DOTT. A. TOSI<br />

FARMACEUTICI S.A.S.<br />

OTOMIZE EAR SPRAY METERED AEROSOL N/A STAFFORD-MILLER<br />

LIMITED<br />

ITALY<br />

UNITED KINGDOM<br />

OTOPAIN EAR DROPS N/A PT INTERBAT INDONESIA<br />

OTORALGYL WITH<br />

PHENYLEPHRINE<br />

EAR SPRAY N/A LABORATOIRES MARTIN-<br />

JOHNSON & JOHNSON-<br />

MSD<br />

OTOSPORIN EAR DROPS N/A THE WELLCOME<br />

FOUNDATION LTD.<br />

FRANCE<br />

UNITED KINGDOM


EN<br />

662 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

OTOSPORIN EAR DROPS NA THE WELLCOME<br />

FOUNDATION LIMITED<br />

UNITED KINGDOM<br />

OTOSPORIN DROPS EAR DROPS NA GLAXOWELLCOME PAKISTAN<br />

OTRINOL PROLONGED RELEASE<br />

CAPSULE<br />

120MG NOVARTIS CONSUMER<br />

HEALTH SA<br />

OTRISAL BABY NASAL SPRAY N/A NOVARTIS CONSUMER<br />

HEALTH — GEBRO<br />

GMBH<br />

OTRIVIN NASAL SPRAY 0.1% W/V NOVARTIS CONSUMER<br />

HEALTH SA<br />

OTRIVIN SOLUTION 0.05% W/V NOVARTIS CONSUMER<br />

HEALTH SA<br />

OTRIVIN SOLUTION 0.1% W/V NOVARTIS CONSUMER<br />

HEALTH SA<br />

OTRIVIN GEL 0.1% W/W NOVARTIS CONSUMER<br />

HEALTH SA<br />

SWITZERLAND<br />

AUSTRIA<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

OTRIVIN NEBULISING SOLUTION N/A CIBA PAKISTAN<br />

OTRIVIN NASAL DROPS 1MG/ML NOVARTIS CONSUMER<br />

HEALTH SCHWEIZ AG<br />

OTRIVIN 0.05% NASAL DROPS 0.5MG/ML NOVARTIS CONSUMER<br />

HEALTH SCHWEIZ AG<br />

OTRIVIN 0.1% NASAL DROPS IN<br />

NEBULISER<br />

1MG/ML NOVARTIS CONSUMER<br />

HEALTH SCHWEIZ AG<br />

OTRIVIN 0.1% NASAL GEL 0.1%W/W NOVARTIS CONSUMER<br />

HEALTH SCHWEIZ AG<br />

OTRIVIN 0.1% METERED DOSE SPRAY 1MG/1ML NOVARTIS CONSUMER<br />

HEALTH SCHWEIZ AG<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

OVRAL COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY<br />

OWS (DICLOFENAC SODIUM) SOLUTION FOR<br />

INJECTION<br />

75MG/2ML UNIMED<br />

PHARMACEUTICALS INC.<br />

OXACID 200 CAPSULES 200MG AEGIS LTD. CYPRUS<br />

OXACTIN CAPSULES 20MG SCHEIN<br />

PHARMACEUTICAL UK<br />

LIMITED<br />

OXILAN — 300 SOLUTION FOR<br />

INJECTION<br />

OXILAN — 350 SOLUTION FOR<br />

INJECTION<br />

300MG IODINE/ML COOK IMAGING<br />

CORPORATION<br />

350MG IODINE/ML COOK IMAGING<br />

CORPORATION<br />

OXIS TURBUHALER INHALATION POWDER 6MCG/AC ASTRA<br />

PHARMACEUTICALS<br />

LIMITED<br />

OXIS TURBUHALER INHALATION POWDER 12MCG/AC ASTRA<br />

PHARMACEUTICALS<br />

LIMITED<br />

OXISEPT SOL.EXT.U.S. 7.5% 75MG DEMO S.A. GREECE<br />

OXISEPT 10% EXTERNAL SOLUTION 10% DEMO SA GREECE<br />

OXSORALEN LOTION 1% W/V ICN PHARMACEUTICALS<br />

INC.<br />

KOREA REPUBLIC<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 663<br />

Trade Name Dosage Form Dose MA Holder Country<br />

OXSORALEN CAPSULE 10MG ICN PHARMACEUTICALS,<br />

INC.<br />

UNITED STATES OF<br />

AMERICA<br />

OXSORALEN CAPSULES 10MG ICN PHARMACEUTICALS UNITED STATES OF<br />

AMERICA<br />

OXSORALEN LOTION 1% V/V ICN PHARMACEUTICALS<br />

INC.<br />

OXSORALEN CAPSULES 10MG ICN PHARMACEUTICALS<br />

INC.<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

OXYBUTYNIN HYDROCHLORIDE TABLET 5MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

OXYBUTYNIN HYDROCHLORIDE TABLETS 5MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

OXYBUTYNIN HYDROCHLORIDE<br />

TABLETS 5MG<br />

TABLET 5MG SANOFI WINTHROP LTD UNITED KINGDOM<br />

OXYTETRACYCLINE TABLETS 250MG NORTON HEALTHCARE<br />

LIMITED<br />

OXYTETRACYCLINE TABLETS 250MG PHARMAMED LTD. MALTA<br />

OXYTETRACYCLINE 100MG TABLET 100MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

OXYTETRACYCLINE BP 250MG TABLET 250MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

OXYTETRACYCLINE BP 50MG TABLET 50MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMETED<br />

OZEPAL TABLETS 5MG DEMO ABEE GREECE<br />

OZOPULMIN SUPPOSITORIES 40MG GEYMONAT SPA ITALY<br />

OZOPULMIN SUPPOSITORIES 80MG GEYMONAT SPA ITALY<br />

OZOPULMIN SUPPOSITORIES 160MG GEYMONAT SPA ITALY<br />

OZOPULMIN GEL N/A GEYMONAT SPA ITALY<br />

OZOPULMIN SYRUP N/A GEYMONAT SPA ITALY<br />

OZOTHINE SYRUP 0.24G/100ML SOCIETE PHOCEAL FRANCE<br />

PABRINEX INTRAMUSCULAR<br />

HIGH POTENCY<br />

PABRINEX INTRAVENOUS HIGH<br />

POTENCY<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

N/A LINK PHARMACEUTICALS<br />

LIMITED<br />

N/A LINK PHARMACEUTICALS<br />

LIMITED<br />

PACIFENE TABLETS 200MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PACIFENE MAXIMUM STRENGTH TABLETS 400MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PACIMOL(PARACETAMOL<br />

TABLETS BP)<br />

PAEDIATRIC PARACETAMOL<br />

ORAL SOLUTION BP<br />

TABLET 500MG IPCA LABORATORIES<br />

LIMITED<br />

ORAL SOLUTION 120MG WILLIAM RANSOM &<br />

SON PLC<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

INDIA<br />

UNITED KINGDOM


EN<br />

664 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PALDESIC (PARACETAMOL<br />

SUSPEN. 120MG/5ML)<br />

ORAL SUSPENSION 120MG/5ML ROSEMONT<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

PALUDRINE TABLETS 100MG ZENECA LIMITED UNITED KINGDOM<br />

PALUDRINE 100MG TABLET 100MG ASTRAZENECA UK<br />

LIMITED<br />

PAMECIL POWDER FOR OR.<br />

SUSPENSION<br />

125MG/5ML MEDOCHEMIE LTD CYPRUS<br />

PAMECIL 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS<br />

PAMECIL 250MG POWDER FOR INJECTION 250MG MEDOCHEMIE LTD CYPRUS<br />

PAMOCIL CAPSULES 1G FARMA UNO SRL ITALY<br />

PAMOL SUSPENSION 120MG/5ML DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LIMITED<br />

PANADOL SUPPOSITORY 500MG SANOFI WINTHROP —<br />

PRODUCTOS<br />

FARMACEUTICOS, LDA.<br />

PANADOL SUPPOSITORY 250MG SANOFI WINTHROP —<br />

PRODUCTOS<br />

FARMACEUTICOS, LDA.<br />

PANADOL SUPPOSITORY 125MG SANOFI WINTHROP —<br />

PRODUCTOS<br />

FARMACEUTICOS, LDA.<br />

UNITED KINGDOM<br />

JORDAN<br />

PORTUGAL<br />

FRANCE<br />

PORTUGAL<br />

PANADOL TABLET 500MG PHARMATEC PAKISTAN<br />

PANADOL TABLET 500MG WINTHROP PAKISTAN<br />

PANADOL COATED EMBOSSED<br />

TABLETS<br />

500MG SMITHKLINE BEECHAM<br />

(IRELAND)<br />

PANADOL 250MG SUPPOSITORIES 250MG GLAXOSMITHKLINE<br />

SANTE GRAND PUBLIC<br />

PANADOL ACTIFAST TABLETS 500MG SMITHKLINE BEECHAM<br />

(IRELAND) LIMITED<br />

PANADOL ACTIFAST TABLET 500MG SMITHKLINE BEECHAM<br />

(SWG) LIMITED T/A GSK<br />

CONSUMER<br />

HEALTHCARE<br />

PANADOL BABY AND INFANT<br />

SUSPENSION<br />

ORAL SUSPENSION 120MG/5ML SMITHKLINE BEECHAM<br />

(SWG) LTD T/A SMITHK.<br />

BEEC. CONSUM. HLTHC<br />

PANADOL COLD AND FLU CAPLETS NA SMITHKLINE BEECHAM<br />

CONSUMER<br />

HEALTHCARE<br />

IRELAND<br />

FRANCE<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

PANADOL EXTRA TABLET N/A PHARMATEC PAKISTAN<br />

PANADOL EXTRA TABLET N/A WINTHROP PAKISTAN<br />

PANADOL EXTRA COATED EMBOSSED<br />

TABLETS<br />

NA SMITHKLINE BEECHAM<br />

(IRELAND) LTD<br />

PANADOL EXTRA TABLETS TABLET N/A SMITHKLINE BEECHAM<br />

(SWG) LIMITED<br />

IRELAND<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 665<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PANADOL SINUS CAPLETS NA SMITHKLINE BEECHAM<br />

CONSUMER<br />

HEALTHCARE<br />

PANADOL SOLUBLE TABLETS<br />

500MG<br />

EFFERVESCENT TABLET 500MG SMITHKLINE BEECHAM<br />

(SWG) LTD T/A STERLING<br />

HEALTH<br />

PANADOL SUPPOSITORIES SUPPOSITORY 125MG SMITHKLINE BEECHAM<br />

SANTE AND HYGIENE<br />

PANADOL TABLETS (500MG) TABLET 500MG SMITHKLINE BEECHAM<br />

(SWG) LIMITED T/A<br />

SMITHKL. BEEC. CONS.<br />

HC<br />

PANADOL ULTRA TABLETS N/A SMITHKLINE BEECHAM<br />

LTD T/A<br />

GLAXOSMITHKLINE<br />

CONS HEALTHCARE<br />

AUSTRALIA<br />

UNITED KINGDOM<br />

FRANCE<br />

PANAGESIC TABLET 30MG MEDOCHEMIE LTD CYPRUS<br />

PANCURONIUM BROMIDE SOLUTION FOR<br />

INJECTION<br />

PANCURONIUM BROMIDE<br />

INJECTION BP 4MG/2ML<br />

SOLUTION FOR<br />

INJECTION<br />

4MG/2ML PHARMAMED<br />

PARENTERALS LTD.<br />

4MG/2ML FAULDING<br />

PHARMACEUTICALS PLC<br />

PANETS CAPLETS TABLET 500MG THE BOOTS COMPANY<br />

PLC<br />

PANETS TABLETS TABLET 500MG THE BOOTS COMPANY<br />

PLC<br />

PANOXYL ACNEGEL 10 GEL 10% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

PANOXYL ACNEGEL 5 GEL 5% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

PANOXYL AQUAGEL 10 GEL 10% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

PANOXYL AQUAGEL 2.5 GEL 2.5% W/W STIEFEL LABORATORIES<br />

(UK) LTD<br />

PANOXYL AQUAGEL 5 GEL 5% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

PANOXYL WASH 10% W/W TOPICAL SUSPENSION 10% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

PANTINE TABLET SUGAR-COATED TABLET 15MG CAMDEN INDUSTRIES (M)<br />

SDN BHD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALTA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

PANTOGAR CAPSULES N/A ADROKA AG SWITZERLAND<br />

PARA PLUS LOTION IN PRESSURISED<br />

BOT<br />

N/A LABORATORE S.C.A.T FRANCE<br />

PARA SPECIAL POUX (LICE) SHAMPOO N/A LABORATOIRES S.C.A.T FRANCE<br />

PARA SPECIAL POUX (LICE) SOL FOR LOCAL<br />

APPLICATION<br />

N/A LABORATOIRES S.C.A.T FRANCE<br />

PARACEN 500 TABLETS 500MG AEGIS LTD. CYPRUS<br />

PARACETAMOL TABLETS 500MG PHARMAMED LTD. MALTA<br />

PARACETAMOL TABLETS 500MG CIPLA LIMITED INDIA


EN<br />

666 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PARACETAMOL 500MG SOLUBLE<br />

TABLETS<br />

TABLET FOR ORAL<br />

SOLUTION<br />

500MG SANOFI WINTHROP LTD UNITED KINGDOM<br />

PARACETAMOL BP 500MG TABLET 500MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

UNITED KINGDOM<br />

PARACETAMOL DENK 125 SUPPOSOTORY 125MG E.DENK OHG GERMANY<br />

PARACETAMOL DENK 250 SUPPOSITORY 250MG E.DENK OHG GERMANY<br />

PARACETAMOL DENK 500' SUPPOSITORY 500MG E.DENK OHG GERMANY<br />

PARACETAMOL INFANT DROPS<br />

100MG/ML<br />

PARACETAMOL TABLET B.P.<br />

500MG<br />

PARACETAMOL TABLET BP<br />

500MG<br />

ORAL SOLUTION 100MG/ML OLINKA UK LIMITED UNITED KINGDOM<br />

TABLET 500MG ASPAR<br />

PHARMACEUTICALS LTD<br />

TABLET 500MG ASPAR<br />

PHARMACEUTICALS LTD<br />

PARACETAMOL TABLETS 500MG TABLET 500MG SANOFI WINTHROP<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

PARACETAMOL TABLETS 500MG TABLET 500MG SANOFI WINTHROP LTD UNITED KINGDOM<br />

PARACETAMOL TABLETS 500MG TABLET 500MG SANOFI WINTHROP<br />

LIMITED<br />

PARACETAMOL TABLETS 500MG TABLET 500MG GEOFMAN<br />

PHARMACEUTICALS<br />

PARACETAMOL TABLETS BP<br />

500MG<br />

PARACETAMOL TABLETS BP<br />

500MG<br />

PARACETAMOL TABLETS BP<br />

500MG<br />

PARACETAMOL TABLETS BP<br />

500MG FEVASTIN<br />

PARACETAMOL+CAFFEINE<br />

TABLETS<br />

PARACETAMOL-RATIOPHARM<br />

125 SUPPOSITORIEN<br />

PARACETAMOL-RATIOPHARM<br />

250 SUPPOSITORIEN<br />

TABLETS 500MG M & A PHARMACHEM<br />

LIMITED — UK<br />

TABLET 500MG OBG PHARMACEUTICALS<br />

LIMITED<br />

TABLETS 500MG OBG PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

PAKISTAN<br />

UNCOATED TABLET 500MG TABLET (INDIA) LIMITED INDIA<br />

TABLET N/A SANOFI WINTHROP<br />

LIMITED T/A STERWIN<br />

MEDICINES<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SUPPOSITORY 125MG RATIOPHARM GMBH GERMANY<br />

SUPPOSITORY 250MG RATIOPHARM GMBH GERMANY<br />

PARACETS TABLET 500MG SUSEEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PARACETS (PARACETS G) CAPSULE 500MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PARACETS PLUS COLD RELIEF<br />

CAPS<br />

CAPSULE N/A SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PARACIL TABLET 500 MG TABLET 500MG SM PHARMACEUTICALS<br />

SDN BHD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

PARAFFIN WHITE SOFT BP OINTMENT 100%W/W LCM LTD UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 667<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PARALDEHYDE INJECTION SOLUTION FOR<br />

INJECTION<br />

5ML/VIAL F.H. FAULDING & CO LTD<br />

(T/A DAVID BULL LABS)<br />

PARALIEF TABLETS 500MG CLONMEL HEALTHCARE<br />

LIMITED<br />

PARAMETTES CHEWABLE<br />

MULTIVIT. PLUS IRON<br />

TABLETS N/A WYETH-AYERST<br />

CANADA INC.<br />

PARAMOL 500 TABLET TABLET 500MG CAMDEN INDUSTRIES (M)<br />

SDN. BHD<br />

PARAPLATIN SOLN. FOR I.V INFUSION 450MG/45ML BRISTOL-MYERS SQUIBB<br />

S.P.A.<br />

PARAPLATIN SOLN. FOR I.V INFUSION 50MG/5ML BRISTOL MYERS SQUIBB<br />

S.P.A.<br />

PARAPLATIN POWDER FOR INJECTION 450MG BRISTOL-MYERS<br />

COMPANY<br />

PARASUPP 125 MG<br />

SUPPOSITORIES<br />

PARASUPP 250 MG<br />

SUPPOSITOPRIES<br />

UNITED KINGDOM<br />

IRELAND<br />

CANADA<br />

MALAYSIA<br />

ITALY<br />

ITALY<br />

SUPPOSITORIES 125 MG DELTA HF ICELAND<br />

SUPPOSITORIES 125MG DELTA HF ICELAND<br />

PARASUPP 60 MG SUPPOSITORIES SUPPOSITORIES 60 MG DELTA HF ICELAND<br />

PARATABS 160 MG<br />

ORODISPERSIBLE<br />

TABLET 160MG DELTA HF ICELAND<br />

PARATABS 500 MG TABLETS TABLETS 500MG DELTA HF ICELAND<br />

PARATABS 80 MG<br />

ORODISPERSIBLE<br />

PARATABS RETARD 500MG<br />

PROLONGED-RELEASE<br />

TABLET 80 MG DELTA HF ICELAND<br />

TABLET 500 MG DELTA HF ICELAND<br />

PARCOTEN 500/10 TABLETS N/A AEGIS LTD. CYPRUS<br />

PARIET TABLETS 10MG JANSSEN-CILAG N.V. BELGIUM<br />

PARIET TABLETS 20MG JANSSEN-CILAG N.V. BELGIUM<br />

UNITED STATES OF<br />

AMERICA<br />

PARIET 10MG ORAL TABLET 10MG EISAI LTD UNITED KINGDOM<br />

PARIET 20MG ORAL TABLET 20MG EISAI LTD UNITED KINGDOM<br />

PARITREL TABLETS 100MG TRIMA ISRAEL<br />

PHARMACEUTICAL<br />

PRODUCTS LIIMITED<br />

ISRAEL<br />

PARKODIN TABLET N/A DELTA HF ICELAND<br />

PARKODIN SUPPOSITORIES N/A DELTA HF ICELAND<br />

PARKODIN FORTE 30/500<br />

TABLETS<br />

PARKODIN FORTE 30/500MG<br />

SUPPOSITORIES<br />

TABLETS N/A DELTA HF ICELAND<br />

SUPPOSITORIES N/A DELTA HF ICELAND<br />

PARLODEL TABLETS 2.5MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

PARLODEL TABLET 2.5MG SANDOZ PAKISTAN<br />

PARLODEL TABLETS 2.5MG NOVARTIS PHARMA N.V BELGIUM


EN<br />

668 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PARLODEL TABLETS 2.5MG NOVARTIS FARMA SPA ITALY<br />

PARLODEL 2.5MG TABLET 2.5MG NOVARTIS PAKISTAN<br />

PARMOL 120 SYRUP SYRUP 120MG/5ML HOVID SDN. BHD. MALAYSIA<br />

PAROXAT TABLETS 20MG OMEGA FARMA ICELAND<br />

PARPLATIN SOLN. FOR I.V INFUSION 150MG/15ML BRISTOL MYERS SQUIBB<br />

S.P.A<br />

PARRASUPP 500 MG<br />

SUPPOSITORIES<br />

PASSIFLORA TABLETS,<br />

NATRACALM<br />

ITALY<br />

SUPPOSITORIES 500 MG DELTA HF ICELAND<br />

COATED TABLET 71.4MG PETER BLACK<br />

HEALTHCARE LTD.<br />

PATANOL 0.1% OPHTHALMIC SOLUTION 0.1% W/V ALCON LABORATORIES<br />

INC.<br />

PAVULON 4MG=2ML SOLUTION FOR<br />

INJECTION<br />

PAVULON 4MG=2ML SOLUTION FOR<br />

INJECTION<br />

PAX INJECTION 10MG/2ML SOLUTION FOR<br />

INJECTION<br />

2MG/ML N.V. ORGANON (PART<br />

OF AKZO NOBEL)<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

NETHERLANDS<br />

2MG/ML N.V.ORGANON NETHERLANDS<br />

10MG/2ML PHARMACARE LIMITED SOUTH AFRICA<br />

PAXIDORM TABLETS TABLETS 25MG NORMA CHEMICALS<br />

LIMITED<br />

PECTYLIN-C EXPECTORANT ORAL LIQUID NA IPCA LABORATORIES<br />

LIMITED<br />

PEDITRACE CONC. F/SOLUTION F/<br />

INF.<br />

PEDITRACE SOLUTION FOR<br />

INFUSION<br />

PEDITRACE SOLUTION FOR<br />

INFUSION<br />

N/A PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

UNITED KINGDOM<br />

INDIA<br />

SWEDEN<br />

N/A FRESENIUS KABI LIMITED UNITED KINGDOM<br />

NA FRESENIUS KABI LIMITED UNITED KINGDOM<br />

PEDVAX HIB VACCINE N/A MERCK SHARP & DOHME NETHERLANDS<br />

PEGASYS SOLUTION FOR<br />

INJECTION<br />

PEGASYS SOLUTION FOR<br />

INJECTION<br />

PEGINTRON POW.AND SOL.F/SOL.F/<br />

INJ.<br />

135MCG/VIAL ROCHE REGISTRATION<br />

LIMITED<br />

180MCG/VIAL ROCHE REGISTRATION<br />

LIMITED<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

SEE REMARKS SP EUROPE EUROPEAN COMMUNITY<br />

PELLIT INSECT GEL GEL 1G/100G KARL ENGELHARD GERMANY<br />

PENBRITIN CAPSULE 250MG SMITH KLINE &<br />

BEECHAM<br />

PENBRITIN CAPSULE 500MG SMITH KLINE &<br />

BEECHAM<br />

PAKISTAN<br />

PAKISTAN<br />

PENBRITIN CAPSULES 250MG CAPSULE 250MG BEECHAM GROUP PLC UNITED KINGDOM<br />

PENBRITIN CAPSULES 500MG CAPSULE 500MG BEECHAM GROUP PLC UNITED KINGDOM<br />

PENBRITIN PAEDIATRIC SUSP.<br />

125MG/1.25ML<br />

POWDER FOR ORAL<br />

SOLUTION<br />

125MG/1.25ML BEECHAM GROUP PLC UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 669<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PENBRITIN SYRUP 125MG/5ML POWDER FOR ORAL<br />

SOLUTION<br />

PENBRITIN SYRUP FORTE POWDER FOR ORAL<br />

SOLUTION<br />

125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM<br />

250MG/5ML BEECHAM GROUP PLC UNITED KINGDOM<br />

PENBRITIN VIALS FOR INJECTION POWDER FOR INJECTION 250MG BEECHAM GROUP PLC UNITED KINGDOM<br />

PENBRITIN VIALS FOR INJECTION POWDER FOR INJECTION 500MG BEECHAM GROUP PLC UNITED KINGDOM<br />

PENFEN TABLETS 50MG ATCO LABORATORIES<br />

(PVT) LTD<br />

PENFEN SOLUTION FOR<br />

INJECTION<br />

75MG/3ML ATCO LABORATORIES<br />

(PVT) LTD<br />

PAKISTAN<br />

PAKISTAN<br />

PENICILLAMINE COATED TABLETS 250MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

PENICILLIN VK TABLETS 250MG ATHLONE<br />

LABORATORIES LIMITED<br />

PENIILLAMINE TABLETS BP<br />

250MG<br />

IRELAND<br />

TABLET 250MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

PENODIL CAPSULES 250MG REMEDICA LTD CYPRUS<br />

PENRAZOL E.C. CAPSULE 20MG ELPEN S.A. GREECE<br />

PENSORDIL TABLET 10MG ELPEN S.A GREECE<br />

PENTACOL TABLETS 400MG SOFAR SPA ITALY<br />

PENTACOQ SUSPENSION FOR<br />

INJECTION<br />

N/A PASTEUR MERIEUX FRANCE<br />

PENTAGLOBIN SOL FOR IV USE 50MG/ML BIOTEST PHARMA GMBH GERMANY<br />

PENTAMIDINE ISETHIONATE SOLUTION FOR<br />

INJECTION<br />

PENTASA MESALAZINE ENEMA<br />

1G<br />

300MG ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

RECTAL SUSPENSION 1G/100ML FERRING<br />

PHARMACEUTICALS<br />

LIMITED<br />

PENTASA SUPPOSITORIES IGM SUPPOSITORY 1G FERRING<br />

PHARMACEUTICALS<br />

LIMITED<br />

PENTASPAN INJECTABLE SOLUTION FOR<br />

INJECTION<br />

N/A DUPONT PHARMA INC CANADA<br />

PENTAZOCINE CAPSULES 50MG NORTON HEALTHCARE<br />

LIMITED<br />

PENTOSTAM SOLUTION FOR<br />

INJECTION<br />

10G/100ML THE WELLCOME<br />

FOUNDATION LIMITED<br />

PENTOTHAL SODIUM POWDER FOR INJECTION 0.5G ABBOTT S.P.A. ITALY<br />

PENTOTHAL SODIUM POWDER FOR INJECTION 1G ABBOTT S.P.A. ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

PEP TABLETS N/A HEALTHY IDEAS LIMITED UNITED KINGDOM<br />

PEPDINE 20MG TABLET 20MG MERCK SHARP & DOHME<br />

B.V.<br />

PEPDINE 40MG TABLET 40MG MERCK SHARP & DOHME<br />

B.V.<br />

NETHERLANDS<br />

NETHERLANDS<br />

PERAZODIN 100 TABLETS 100MG REMEDICA LTD CYPRUS


EN<br />

670 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PERFANE 100MG/20ML IV INJ. SOLN FOR<br />

DILUTION<br />

PERFORMER MODIFIED RELEASE<br />

TABLET<br />

PERFORMER GRANULES FOR ORAL<br />

SUSP.<br />

PERGONAL POWDER FOR<br />

INJECTABLE SOL<br />

100MG/20ML LABORATOIRES MARION<br />

MERRELL DOW S.A.<br />

FRANCE<br />

750MG VECCHI & PIAM S.A.P.A ITALY<br />

250MG/5ML VECCHI & C. PIAM<br />

S.A.P.A<br />

ITALY<br />

N/A SERONO PHARMA S.P.A. ITALY<br />

PERGONAL 150IU POWDER FOR INJECTION N/A LABORATOIRES SERONO<br />

SA<br />

PERGONAL 75IU INJECTABLE<br />

PREPARATION<br />

75IU HMG/ML LABORATOIRES SERONO<br />

SA<br />

PERIACTIN 4MG TABLET 4MG MERCK SHARP & DOHME<br />

B.V.<br />

PERIDON TABLET 10MG ITALCHIMICI SPA ITALY<br />

PERIDON SUPPOSITORIES 30MG ITALCHIMICI SPA ITALY<br />

PERIDON SUPPOSITORIES 60MG ITALCHIMICI SPA ITALY<br />

PERIDON SYRUP 100MG/100ML ITALCHIMICI SPA ITALY<br />

PERINORM (METOCLOPRAMIDE<br />

TABLETS BP)<br />

PERISET-4 (ONDANSETRON<br />

TABLETS)<br />

TABLET 10MG IPCA LABORATORIES<br />

LIMITED<br />

TABLET 4MG IPCA LABORATORIES<br />

LIMITED<br />

PERLUTEX TABLETS 5MG LEO PHARMACEUTICAL<br />

PRODUCTS<br />

SWITZERLAND<br />

SWITZERLAND<br />

NETHERLANDS<br />

INDIA<br />

INDIA<br />

DENMARK<br />

PEROFEN 200 TABLETS 200MG REMEDICA LTD CYPRUS<br />

PERPECTOR DROPS N/A DR.GROSSMANN AG<br />

PHARMACA<br />

PERSANTIN S.C. TABLET 25MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

PERSANTIN S.C. TABLET 75MG BOEHRIGER INGELHEIM<br />

PHARMA KG<br />

SWITZERLAND<br />

GERMANY<br />

GERMANY<br />

PERSANTIN SUGAR COATED TABLET 25MG BOEHRINGER-INGELHEIM PAKISTAN<br />

PERSANTIN TABLETS 100MG BOEHRINGER INGELHEIM PAKISTAN<br />

PERSANTIN 100MG SUGAR COATED TABLET 100MG BOEHRINGER-INGELHEIM PAKISTAN<br />

PERSKINDOL CLASSIC GEL N/A PHARMA-SINGER AG SWITZERLAND<br />

PERSKINDOL CLASSIC SPRAY N/A PHARMA-SINGER AG SWITZERLAND<br />

PERSKINDOL CLASSIC LINIMENT N/A PHARMA-SINGER AG SWITZERLAND<br />

PERSKINDOL CLASSIC BATH-OIL N/A PHARMA-SINGER AG SWITZERLAND<br />

PETHIDINE SOLUTION FOR<br />

INJECTION<br />

PETHIDINE INJECTION BP<br />

50MG/ML<br />

SOLUTION FOR<br />

INJECTION<br />

100MG/2ML DUOPHARMA(M)<br />

SDN.BHD.<br />

50MG/ML ANITGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

MALAYSIA<br />

IRELAND


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 671<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PETHIDINE INJ. BP SOLUTION FOR<br />

INJECTION<br />

PETHIDINE INJECTION SOLUTION FOR<br />

INJECTION<br />

PETHIDINE INJECTION SOLUTION FOR<br />

INJECTION<br />

5% W/V MACARTHYS<br />

LABORATORIES LTD T/A<br />

MARTINDALE<br />

PHARMACEUTICALS<br />

50MG/1ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

100MG/2ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

PEVARYL POWDER 10MG/G JANSSEN-CILAG AG SWITZERLAND<br />

PEVARYL CREAM 10MG/G JANSSEN-CILAG N.V. SWITZERLAND<br />

PEVARYL CREAM 1G/100G JANSSEN-CILAG N.V. BELGIUM<br />

PEVARYL MILK 10MG/G JANSSEN-CILAG AG SWITZERLAND<br />

PEVARYL 1% SOLUTION 1G/100G JANNSEN-CILAG AG SWITZERLAND<br />

PEVARYL LIPOGEL GEL 10MG/G JANSSEN-CILAG AG SWITZERLAND<br />

PEVARYL PV FOAMING SOLUTION 1G/100G JANSSEN-CILAG AG SWITZERLAND<br />

PEVARYL SHAMPOO SOLUTION 10MG/G JANSSEN-CILAG AG SWITZERLAND<br />

PEVISONE CREAM N/A JANSSEN-CILAG AG SWITZERLAND<br />

PEVISONE CREAM N/A JANSSEN-CILAG N.V. BELGIUM<br />

PHARMATOVIT CAPSULES N/A PHARMATON SA SWITZERLAND<br />

PHENERGAN ELIXIR 5MG/5ML RHONE-POULENC-RORER PAKISTAN<br />

PHENERGAN ELIXIR ORAL SOLUTION 5MG/5ML MAY & BAKER LIMITED UNITED KINGDOM<br />

PHENERGAN INJECTION 2.5% W/V SOLUTION FOR<br />

INJECTION<br />

2.5% W/V MAY & BAKER LIMITED<br />

(REFER TO CPP)<br />

PHENERGAN TABLETS 10MG COATED TABLET 10MG MAY & BAKER LIMITED<br />

(T/A RHONE-POULENC<br />

RORER)<br />

PHENERGAN TABLETS 25MG COATED TABLET 25MG MAY & BAKER LIMITED<br />

(T/A RHONE-POULENC<br />

RORER)<br />

PHENINDIONE TABLETS TABLETS 50MG GOLDSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

PHENOBARBITAL TABLETS 30MG PHARMAMED LTD. MALTA<br />

PHENOBARBITONE BP 60MG TABLET 60MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PHENOBARBITONE BP 15MG TABLETS 15MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PHENOBARBITONE BP 30MG TABLET 30MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PHENOBARBITONE TABLETS BP<br />

30MG<br />

TABLETS 30MG APPROVED<br />

PRESCRIPTION SERVICES<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

672 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PHENOL OILY BP OIL FOR INJECTION 5%W/V EVANS MEDICAL LIMITED UNITED KINGDOM<br />

PHENOXYBENZAMINE INJECTION<br />

CONCENTRATE<br />

SOLUTION FOR<br />

INJECTION<br />

100MG/2ML FORLEY LIMITED IRELAND<br />

PHENOXYMETHYLPENICILLIN 250 TABLETS 250 MG REMEDICA LTD CYPRUS<br />

PHENSEDYL WITH CODEINE<br />

COUGH LINCTUS<br />

ORAL SOLUTION N/A MAY & BAKER (T/A<br />

RHONE-POULENC<br />

RORER)'<br />

PHENYLBUTAZONE BP 100MG TABLET 100MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PHENYLBUTAZONE BP 200MG TABLET 200MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PHILLIP'S MILK OF MAGNESIA ORAL SUSPENSION 415MG/5ML SMITHKLINE BEECHAM<br />

(SWG) LTD T/A STERLING<br />

HEALTH<br />

PHILLIP'S MILK OF MAGNESIA<br />

TABLETS<br />

PHLOGENZYM GASTRO-RESISTANT<br />

TABLET<br />

TABLET 300MG SMITHKLINE BEECHAM<br />

(SWG) LTD T/A STERLING<br />

HEALTH/SKB INTRNTL<br />

N/A MUCOS PHARMA GMBH<br />

& CO.<br />

PHOLCODINE LINCTUS B.P. ORAL SOLUTION 5MG/5ML WILLIAM RANSOM &<br />

SON PLC<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

UNITED KINGDOM<br />

PHOLCODINE LINCTUS BP ORAL SOLUTION 5MG LCM LTD UNITED KINGDOM<br />

PHOSPHATE SODIQUE DE<br />

DEXAMETHASONE MERCK<br />

PHYLLOCONTIN CONTINUS<br />

TABLETS 225MG<br />

PHYLLOCONTIN FORTE<br />

CONTINUS TABS. 350MG<br />

PHYLLOCONTIN PAEDIATRIC<br />

CONTINUS TABLETS<br />

SOL FOR INJECTION IN<br />

AMP<br />

MODIFIED RELEASE<br />

TABLET<br />

MODIFIED RELEASE<br />

TABLETS<br />

MODIFIED RELEASE<br />

TABLET<br />

PHYSIONEAL GLUCOSE SOL.F PERITONEAL<br />

DIALYSIS<br />

4MG MERCK GENERIQUES FRANCE<br />

225MG NAPP LABORATORIES<br />

LIMITED<br />

350MG NAPP LABORATORIES<br />

LIMITED<br />

100MG NAPP LABORATORIES<br />

LIMITED<br />

N/A BAXTER HEALTHCARE<br />

LIMITED UK<br />

PHYSIONEAL GLUCOSE SOLUTION N/A BAXTER HEALTHCARE<br />

LIMITED UK<br />

PHYSIONEAL GLUCOSE 3.86%W/V SOL. F. PERITONEAL<br />

DIALYS<br />

N/A BAXTER HEALTHCARE<br />

LIMITED UK<br />

PHYSIOTENS 0.2 FILM COATED TABLET 0.2MG SOLVAY ARZNEIMITTEL<br />

GMBH<br />

PHYSIOTENS 0.3 FILM COATED TABLET 0.3MG SOLVAY ARZNEIMITTEL<br />

GMBH<br />

PHYSIOTENS 0.4 FILM COATED TABLET 0.4MG SOLVAY ARZNEIMITTEL<br />

GMBH<br />

PHYTEX PAINT PAINT N/A WYNLIT LABORATORIES<br />

LIMITED<br />

PHYTOMENADIONE INJECTION BP<br />

10MG (VITAMIN K1 INJECTION<br />

10MG)<br />

SOLUTION FOR<br />

INJECTION<br />

10MG/1ML ROTEXMEDICA GMBH,<br />

ARZNEIMITTELWERK<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

UNITED KINGDOM<br />

GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 673<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PICKLES OINTMENT OINTMENT N/A J PICKLES (HARROGATE)<br />

LIMITED T/A J. PICKLES<br />

AND SON<br />

PICOLAX POWDER POWDER FOR ORAL<br />

SOLUTION<br />

N/A FERRING<br />

PHARMACEUTICALS<br />

LIMITED<br />

PICO-SALAX POWDER SINGLE DOSE N/A FERRING AB SWEDEN<br />

PIL-FOOD CAPSULE N/A LABORATOIRE GOLAZ<br />

SA<br />

PIL-FOOD CAPSULES CAPSULES NA LABORATOIRE GOLAZ<br />

SA<br />

PILOCARPINA CLORIDRATO SOLUTION 4% COLLIRIO TUBILUX PHARMA S.P.A. ITALY<br />

PILOCARPINE 1% EYE DROPS (OPTIFILM) 0.01G/ML AMOUN<br />

PHARMACEUTICAL<br />

INDUSTRIES CO.<br />

PILOCARPINE 2% EYE DROPS(OPTIFILM) 0.02G/ML AMOUN<br />

PHARMACEUTICAL<br />

INDUSTRIES CO.<br />

PILOCARPINE EYE DROPS 0.5% EYE DROPS 0.5% W/W SCHERING-PLOUGH<br />

LIMITED<br />

PILOCARPINE EYE DROPS 1% BP EYE DROPS 1% W/V SCHERING-PLOUGH<br />

LIMITED<br />

PILOCARPINE EYE DROPS 2% BP EYE DROPS 2% W/V SCHERING-PLOUGH<br />

LIMITED<br />

PILOCARPINE EYE DROPS 3% EYE DROPS 3% W/V SCHERING-PLOUGH<br />

LIMITED<br />

PILOCARPINE EYE DROPS 4% EYE DROPS 4% W/V SCHERING-PLOUGH<br />

LIMITED<br />

PILOCARPINE EYE DROPS BP 1% EYE DROPS 1%W/V MARTINDALE<br />

PHARMACEUTICALS LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

EGYPT<br />

EGYPT<br />

PILOCOLLYRE EYE DROPS SOLUTION 4% W/V COOPER S.A. GREECE<br />

PILOCOLLYRE EYE DROPS SOLUTION 1% W/V COOPER S.A. GREECE<br />

PILOCOLLYRE EYE DROPS SOLUTION 2% W/V COOPER S.A. GREECE<br />

PILODREN EYE DROPS N/A FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

PILOPOS 2% EYE DROPS 2% W/V URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

PILOTONINA EYE DROPS 2% W/V FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

PILOTONINA EYE DROPS 4% W/V FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

PIMAFUCIN CREAM 20MG/G YAMANOUCHI PHARMA<br />

B.V.<br />

PIMAFUCORT CREAM N/A YAMANOUCHI PHARMA<br />

B.V.<br />

PINADONE METHADONE<br />

MIXTURE DTF<br />

ORAL SOLUTION 1MG/ML PINEWOOD<br />

LABORATORIES LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

GERMANY<br />

ITALY<br />

ITALY<br />

NETHERLANDS<br />

NETHERLANDS<br />

IRELAND


EN<br />

674 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PINADONE METHADONE<br />

MIXTURE DTF<br />

PINORAX STRONG<br />

CO-DANTHRAMER<br />

ORAL SOLUTION, SUGAR<br />

FREE<br />

1MG/ML PINEWOOD<br />

LABORATORIES LIMITED<br />

ORAL SUSPENSION 75/1000 PINEWOOD<br />

LABORATORIES LIMITED<br />

PIPRIL 1G POWDER FOR INJECTION 1G/10ML LEDERLE<br />

PHARMACEUTICALS<br />

PIPRIL 2G POWDER FOR INJECTION 2G/20ML LEDERLE ARZNEIMITTEL<br />

GMBH & CO<br />

PIPRIL INJECTION POWDER FOR INJECTION 4G/VIAL CYANAMID OF GREAT<br />

BRITAIN LTD.<br />

PIPRIL INJECTION POWDER FOR INJECTION 2G/VIAL CYANAMID OF GREAT<br />

BRITAIN LTD.<br />

PIRACTAM CAPSULES 10MG KOREA UNITED PHARM.<br />

INC.<br />

PIRFALIN OPHTHALMIC DROPS 0.005% W/V FARMIGEA SPA ITALY<br />

PIRITON TABLET 4MG STAFFORD-MILLER<br />

LIMITED<br />

PIRITON SYRUP 2MG/5ML STAFFORD-MILLER<br />

LIMITED<br />

PIRITON SYRUP SYRUP (ORAL SOLUTION) 2MG/5ML STAFFORD MILLER<br />

LIMITED<br />

PIRITON TABLETS TABLET 4MG STAFFORD MILLER<br />

LIMITED<br />

PIROXICAM CAPSULES 10MG NORTON HEALTHCARE<br />

LIMITED<br />

PIROXICAM CAPSULE 20MG NORTON HEALTHCARE<br />

LIMITED<br />

PITRESSIN SOLUTION FOR<br />

INJECTION<br />

PITRESSIN AMPOULES SOLUTION FOR<br />

INJECTION<br />

0.4 MG/1 ML GOLDSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

20PU GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED<br />

IRELAND<br />

IRELAND<br />

GERMANY<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

KOREA REPUBLIC<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

PK-MERZ INFUSION SOLUTION 200 MG MERZ+CO. GMBH & CO. GERMANY<br />

PK-MERZ TABLETS 100 MG MERZ+CO. GMBH & CO. GERMANY<br />

PLACIS INJECTABLE SOLUTION 10MG/10ML CHIESI ESPANA S.A. SPAIN<br />

PLACIS INJECTABLE SOLUTION 50MG/50ML CHIESI ESPANA S.A. SPAIN<br />

PLACIS 10MG SOLUTION INJECTABLE 10MG/20ML CHIESI WASSERMANN<br />

S.A.<br />

PLACIS 50MG SOLUTION INJECTABLE 50MG/50ML CHIESI WASSERMANN<br />

S.A.<br />

PLAQUENIL TABLET 200MG SANOFI WINTHROP LTD. UNITED KINGDOM<br />

PLASMA-LYTE 148 ELECTROLYTE<br />

SOL IN WATER<br />

SOLUTION FOR<br />

INJECTION<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

PLATINWAS INJECTABLE SOLUTION 150MG/15ML CHIESI ESPANA S.A. SPAIN<br />

SPAIN<br />

SPAIN<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 675<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PLAVIX FILM COATED TABLETS 75MG SANOFI PHARMA<br />

BRISTOL-MYERS SQUIBB<br />

SNC<br />

FRANCE<br />

PLEGISOL SOLUTION N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

PLEGISOL SOLN F/CARDIAC<br />

PERFUSION<br />

SOLN F/CARDIAC<br />

PERFUSION<br />

N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

PLEGIVEX CARDIOPLEGIA SOLUTION NA GALEN LIMITED UNITED KINGDOM<br />

PLENDIL PROLONGED RELEASE<br />

TABLETS<br />

PLENDIL PROLONGED RELEASE<br />

TABLETS<br />

5MG HASSLE LAKEMEDEL AB SWEDEN<br />

10MG HASSLE LAKEMEDEL AB SWEDEN<br />

PMS- HALOPERIDOL SOLUTION ORAL SOLUTION 2MG/ML PHARMASCIENCE INC. CANADA<br />

PMS-IPRATROPIUM LIQUID 250MCG/ML PHARMASCIENCE INC. CANADA<br />

PMS-SELEGILENE TABLET 5MG PHARMASCIENCE INC. CANADA<br />

PNEUMO 23 SOLUTION FOR<br />

INJECTION<br />

N/A PASTEUR MERIEUX FRANCE<br />

PNEUMOREL 0.2% SYRUP 0.2% W/V LES LABORATOIRES<br />

SERVIER<br />

PNEUMOREL 80MG COATED TABLET 80MG LES LABORATOIRES<br />

SERVIER<br />

POFOL INJECTION SUSPENSION FOR<br />

INJECTION<br />

10MG/ML DONG KOOK PHARM.<br />

CO. LTD<br />

POLARAMINE SYRUP 0.40MG/ML SCHERING-PLOUGH<br />

NV/SA<br />

FRANCE<br />

FRANCE<br />

KOREA REPUBLIC<br />

BELGIUM<br />

POLARAMINE EXPECTORANT SYRUP N/A SCHERING-PLOUGH S.A. BELGIUM<br />

POLARMINE REPETABS 6MG SCHERING-PLOUGH<br />

NV/SA<br />

BELGIUM<br />

POLARONIL TABLETS N/A SCHERING-PLOUGH S.A. BELGIUM<br />

POLJODURATO OPHTHALMIC DROPS N/A FARMIGEA SPA ITALY<br />

POLYDERM OINTMENT USP OINTMENT N/A TARO<br />

PHARMACEUTICALS INC.<br />

POLYFAX OPHTHALMIC OINTMENT N/A THE WELLCOME<br />

FOUNDATION LTD.<br />

POLYFAX OINTMENT OINTMENT N/A THE WELLCOME<br />

FOUNDATION LIMITED<br />

POLYGNAX VAGINAL CAPSULE N/A LABORATOIRE<br />

INNOTECH<br />

INTERNATIONAL<br />

POLYGYNAX VAGINAL CAPSULE N/A LABORATOIRE<br />

INNOTECH<br />

INTERNATIONAL<br />

POLYOSIDE MENINGOCOCCAL<br />

A+C VACCINE<br />

CANADA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

INJECTABLE N/A PASTEUR MERIEUX FRANCE<br />

POLYSILANE DELALANDE CHEWABLE TABLET N/A LABORATOIRES<br />

SYNTHELABO<br />

FRANCE


EN<br />

676 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

POLYSILANE NOURRISSON<br />

JOULLIE<br />

GRANULATES N/A LABORATOIRES<br />

SYNTHELABO<br />

POLYTAR LIQUID 1% W/W STIEFEL LABORATORIES<br />

(UK) LTD<br />

POLYTAR ANTI-FUNGAL SHAMPOO N/A STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

POLYTAR EMOLLIENT TOPICAL SOLUTION 25% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

POLYTAR PLUS TOPICAL SOLUTION 1% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

POLYTONYL FOR ADULTS POWDER FOR ORAL<br />

SOLN<br />

POLYTONYL FOR CHILDREN POWDER FOR ORAL<br />

SOLN<br />

FRANCE<br />

IRELAND<br />

N/A UPSA CONSEIL FRANCE<br />

N/A UPSA CONSEIL FRANCE<br />

POLYTRIM OPHTHALMIC OINTMENT N/A THE WELLCOME<br />

FOUNDATION LTD.<br />

POLYTRIM EYE DROPS N/A THE WELLCOME<br />

FOUNDATION LTD.<br />

PONDOCILLIN TABLETS 500MG LEO PHARMACEUTICAL<br />

PRODUCTS<br />

PONSTAN SYRUP 50MG/5ML PARKE DAVIS &<br />

COMPANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

DENMARK<br />

UNITED KINGDOM<br />

PONSTAN CAPSULE 250MG PARKE-DAVIS GMBH GERMANY<br />

PONSTAN FORTE FILMCOATED TABLET 500MG GODECKE AG GERMANY<br />

PONSTAN FORTE TABLET 500MG PARKE DAVIS PAKISTAN<br />

PONSTAN FORTE TABLET 500MG PARKE-DAVIS PAKISTAN<br />

PONSTYL CAPSULE 250MG PARKE-DAVIS AFRIQUE<br />

DE L'OUEST<br />

PONSTYL FORT 500MG TABLET 500MG PARKE-DAVIS AFRIQUE<br />

DE L'OUEST<br />

PONSTYL SIROP ENFANT SYRUP 50MG/5ML PARKE-DAVIS AFRIQUE<br />

DE L'OUEST<br />

PORFYROCIN 125MG/5ML POWDER FOR OR.<br />

SUSPENSION<br />

PORFYROCIN 250MG/5ML POWDER FOR OR.<br />

SUSPENSION<br />

PORFYROCIN 500MG/5ML POWDER FOR OR.<br />

SUSPENSION<br />

SENEGAL<br />

SENEGAL<br />

SENEGAL<br />

125MG/5ML MEDOCHEMIE LTD CYPRUS<br />

250MG/5ML MEDOCHEMIE LTD CYPRUS<br />

500MG/5ML MEDOCHEMIE LTD CYPRUS<br />

PORPHYROCIN 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS<br />

POSALFILIN OINTMENT N/A NORGINE LIMITED UNITED KINGDOM<br />

POSALFILIN OINTMENT N/A NORGINE LIMITED UNITED KINGDOM<br />

POSIFENICOL 1 % EYE DROPS 1 % W/V URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

POSIFENICOL C 1 % EYE OINTMENT 1 % W/W URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

GERMANY<br />

GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 677<br />

Trade Name Dosage Form Dose MA Holder Country<br />

POTABA ENVULES 3G ORAL POWDER 3G GLENWOOD UNITED KINGDOM<br />

POTASSIUM CHLORIDE 20%<br />

AGUETTANT<br />

POTASSIUM CHLORIDE 20%<br />

AGUETTANT<br />

SOLUTION FOR<br />

INFUSION<br />

20G/100ML LABORATOIRE<br />

AGUETTANT<br />

INJECTABLE SOLUTION 20% W/V LABORATOIRE<br />

AGUETTANT<br />

POTRELEASE TR TABLET 600MG TABLET 600MG SM PHARMACEUTICALS<br />

SDN BHD<br />

POVIDONE IODINE TOPICAL SOLUTION 10GM/100ML AMOUN<br />

PHARMACEUTICAL CO<br />

S.A.E<br />

PR HEAT SPRAY TOPICAL SPRAY N/A CROOKES HEALTHCARE<br />

LIMITED<br />

FRANCE<br />

FRANCE<br />

MALAYSIA<br />

EGYPT<br />

PRAZIQUANTEL FILM COATED TABLETS 600MG PHARMAMED LTD. MALTA<br />

PRAZOSIN TABLETS BP 0.5MG TABLETS 0.5MG NORTON HEALTHCARE<br />

LIMITED<br />

PRAZOSIN TABLETS BP 1MG TABLETS 1MG NORTON HEALTHCARE<br />

LIMITED<br />

PRAZOSIN TABLETS BP 2MG TABLETS 2MG NORTON HEALTHCARE<br />

LIMTED<br />

PRAZOSIN TABLETS BP 5MG TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

PRECONCEIVE TABLETS 400MCG TABLET 400MCG G R LANE PRODUCTS<br />

LTD<br />

PRED FORTE OPHTHALMIC<br />

SUSPENSION<br />

PREDFOAM FOAM RETENTION<br />

ENEMA<br />

1% W/V ALLERGAN<br />

PHARMACEUTICALS<br />

(IRELAND) LTD., INC.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

31.4MG/DOSE PHARMAX LIMITED UNITED KINGDOM<br />

PREDNISOLON TABLETS 5MG NYCOMED AUSTRIA<br />

GMBH<br />

PREDNISOLONE ENTERIC COATED<br />

TABLETS<br />

5MG BIOREX LABORATORIES<br />

LTD.<br />

PREDNISOLONE TABLET 5MG CAMDEN INDUSTRIES (M)<br />

SDN.BHD<br />

PREDNISOLONE TABLETS 20MG CLONMEL HEALTHCARE<br />

LIMITED<br />

PREDNISOLONE BP 1MG TABLET 1MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PREDNISOLONE BP 5MG TABLETS 5MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PREDNISOLONE TABLETS BP 1MG TABLETS 1MG CP PHARMACEUTICALS<br />

LTD.<br />

PREDNISOLONE TABLETS BP 1MG TABLET 1MG CP PHARMACEUTICALS<br />

LTD<br />

PREDNISOLONE TABLETS BP 5MG TABLETS 5MG CP PHARMACEUTICALS<br />

LTD.<br />

AUSTRIA<br />

UNITED KINGDOM<br />

MALAYSIA<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

PREDNISOLON-RATIOPHARM 5 TABLET 5MG RATIOPHARM GMBH GERMANY


EN<br />

678 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PREFRIN PHENYLEPHRINE HCL<br />

LIQUIFILM<br />

EYE DROPS 1.2MG/ML ALLERGAN<br />

PHARMACEUTICALS<br />

(IRELAND) LTD., INC.<br />

PREMAK-C TABLET N/A JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

—UK<br />

PREMAK-C COATED TABLET 1.25MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

—UK<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

PREMARIN TABLET 0.625MG WYETH LEDERLE PAKISTAN<br />

PREMARIN 0.625MG TABLET 0.625MG WYETH-LEDERLE PAKISTAN<br />

PREMARIN 0.625MG TABLETS 0.625MG JOHN WYETH &<br />

BROTHER LTD.<br />

PREMARIN 0.625MG COATED TABLET 0.625MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES -<br />

UK<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

PREMARIN 1.25MG TABLET 1.25MG WYETH-LEDERLE PAKISTAN<br />

PREMARIN 1.25MG TABLETS 1.25MG JOHN WYETH &<br />

BROTHER LTD.<br />

PREMARIN COATED TABLET COATED TABLET 0.625MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

PREMARIN TABLETS 1.25MG. TABLET 1.25MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

—UK<br />

PREMARIN VAGINAL CREAM CREAM 0.625MG / G WYETH-AYERST<br />

CANADA INC.<br />

PREMARIN VAGINAL CREAM CREAM 34.72MG JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES -<br />

UK<br />

PREMELLE 2.5 TABLETS NA JOHN WYETH AND<br />

BROTHER LIMITED<br />

PREMELLE 5 TABLET N/A JOHN WYETH &<br />

BROTHER LTD<br />

PREMELLE CYCLE 10 TABLETS TABLETS NA JOHN WYETH &<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

PREMELLE CYCLE 5 TABLETS NA JOHN WYETH AND<br />

BROTHER LIMITED<br />

PREMIQUE COATED TABLETS NA JOHN WYETH &<br />

BROTHER LIMITED<br />

PREMIQUE CYCLE TABLETS NA JOHN WYETH &<br />

BROTHER<br />

PREMPACK-C 0.625MG TABLETS 0.625MG JOHN WYETH &<br />

BROTHER LTD<br />

PREMPACK-C 0.625MG TABLETS 0.625MG JOHN WYETH &<br />

BROTHER LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CANADA<br />

UNITED KINGDOM<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 679<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PREMPACK-C 1.25MG TABLET 1.25MG JOHN WYETH &<br />

BROTHER LTD.<br />

PREMPAK-C 1.25MG TABLETS 1.25MG JOHN WYETH &<br />

BROTHER LTD<br />

PRENOL TABLETS 5MG AEGIS LTD CYPRUS<br />

PREPERATION H OINTMENT N/A WHITEHALL<br />

LABORATORIES LTD<br />

PREPERATION H SUPPOSITORIES N/A WHITEHALL<br />

LABORATORIES LTD<br />

PREPULSID (CYPRID) 5MG TABLET 5MG JANSSEN-CILAG N.V. BELGIUM<br />

PREPULSID 10MG TABLET 10MG JANSSEN-CILAG N.V. BELGIUM<br />

PREPULSID 1MG/ML ORAL SUSPENSION 1MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

PRESSICAINE A SANS<br />

VASOCONSTRICTEUR 3%<br />

SOLN FOR DENTAL<br />

INJECTION<br />

PRESSICAINE N SOLUTION FOR DENTAL<br />

INJ<br />

3% W/V LABORATOIRES SPAD FRANCE<br />

N/A LABORATOIRES SPAD FRANCE<br />

PRETERAX SCORED TABLET N/A LES LABORATOIRES<br />

SERVIER<br />

PREVENAR SUSPENSION FOR<br />

INJECTION<br />

NA WYETH LEDERLE<br />

VACCINES SA<br />

PRIMALAN SYRUP 0.03G/60ML LABORATOIRES PIERRE<br />

FABRE MEDICAMENT<br />

PRIMALAN 5MG SCORED TABLET 5MG LABORATOIRES PIERRE<br />

FABRE MEDICAMENT<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

EUROPEAN COMMUNITY<br />

FRANCE<br />

FRANCE<br />

PRIMOLUT N TABLET 5MG SCHERING AG GERMANY<br />

PRIMOLUT N TABLET 5MG SCHERING PAKISTAN<br />

PRIMOLUT N TABLETS 5MG SCHERING PAKISTAN<br />

PRIMOLUT N TABLET 5MG SCHERING HEALTH CARE<br />

LIMITED<br />

PRIMPERAN ORAL SOLUTION DROPS 260MG/100ML LABORATOIRES<br />

SYNTHELABO<br />

PRIMPERAN 0.1% ORAL SOLUTION 0.1% W/V LABORATOIRES<br />

SYNTHELABO<br />

PRIMPERAN 10MG SCORED TABLET 10MG LABORATOIRES<br />

SYNTHELABO<br />

PRIMPERAN 10MG/2ML SOLUTION FOR<br />

INJECTION<br />

10MG/2ML LABORATOIRES<br />

SYNTHELABO<br />

PRIODERM LOTION 0.5% LOTION 0.5%W/V MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

PRIODERM SHAMPOO SHAMPOO 1%W/W MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

PRIORIX POWDER FOR INJECTION N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

CYPRUS<br />

CYPRUS<br />

BELGIUM<br />

PRITOR TABLETS 80MG GLAXO GROUP LTD. UNITED KINGDOM<br />

PRITOR TABLETS 40MG GLAXO GROUP LTD. UNITED KINGDOM


EN<br />

680 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PROCARDIN 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS<br />

PROCARDIN 75MG TABLET 75MG MEDOCHEMIE LTD CYPRUS<br />

PROCHLORPERAZINE TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

PROCHLORPERAZINE INJECTION SOLUTION FOR<br />

INJECTION<br />

PROCHLORPERAZINE INJECTION<br />

BP<br />

SOLUTION FOR<br />

INJECTION<br />

1.25%W/V ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

12.5MG/ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

PROCHLORPERAZINE MALEATE TABLETS 5MG PHARMAMED LTD. MALTA<br />

PROCTOFOAM HEMORRHOIDAL FOAM N/A SCHWARZ PHARMA UNITED STATES OF<br />

AMERICA<br />

PROCTOFOAM-HC TOPICAL AEROSOL N/A SCHWARZ PHARMA INC. UNITED STATES OF<br />

AMERICA<br />

PROCTO-GLYVENOL CREAM N/A NOVARTIS CONSUMER<br />

HEALTH SA<br />

PROCTO-GLYVENOL SUPPOSITORIES N/A NOVARTIS CONSUMER<br />

HEALTH SA<br />

PROCTOSEDYL OINTMENT OINTMENT N/A HOECHST MARION<br />

ROUSSEL LIMITED<br />

PROCTOSEDYL SUPPOSITORIES SUPPOSITORY N/A HOECHST MARION<br />

ROUSSEL LIMITED<br />

PROCTOSOLL CREAM N/A ALFA WASSERMANN<br />

S.P.A.<br />

PROCYCLIDINE TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

PROCYCLIDINE SYR. SUG. FREE<br />

ARPICOLIN SF<br />

PROFASI 10000 IU INJECTABLE<br />

PREPARATION<br />

PROFASI 5000IU INJECTABLE<br />

PREPARATION<br />

PROFASI HP POWDER AND SOLVENT<br />

FOR INJ.<br />

ORAL SOLUTION 5MG/5ML ROSEMONT<br />

PHARMACEUTICALS<br />

LIMITED<br />

10000 IU HCG/ML LABORATOIRES SERONO<br />

SA<br />

5000IU HCG/ML LABORATOIRES SERONO<br />

SA<br />

SWITZERLAND<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

ITALY<br />

N/A SERONO PHARMA S.P.A. ITALY<br />

PROFENID GEL 2.5% LABORATOIRES AVENTIS FRANCE<br />

PROFENID 100MG SUPPOSITORIES 100MG LABORATOIRES SPECIA FRANCE<br />

PROFENID 100MG FILM-COATED TABLET 100MG LABORATOIRES SPECIA FRANCE<br />

PROFENID 100MG (IV USE) POWDER F.SOLN.F.<br />

INJECTION<br />

PROFENID 100MG,<br />

INTRAMUSCULAR<br />

POWDER AND SOLVENT<br />

FOR INJ<br />

100MG/VIAL RHONE-POULENC RORER FRANCE<br />

N/A SPECIA LABORATORIES FRANCE<br />

PROFENID 2.5 PER CENT GEL N/A RPR SPECIA<br />

LABORATORIES<br />

FRANCE<br />

PROFENID 50MG CAPSULE 50MG LABORATOIRES SPECIA FRANCE<br />

PROFENID LP 200MG SR FILM COATED TABLET 200MG RHONE-POULENC RORER FRANCE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 681<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PROFLAVINE CREAM B.P.C.1973 CREAM N/A THORNTON & ROSS LTD UNITED KINGDOM<br />

PROGEMOX TABLET 1G PROGE FARM S.R.L. ITALY<br />

PROGEMOX COMPRESSE 1G PROGE FARM S.R.L ITALY<br />

PROGERON TABLETS 100MG REMEDICA LTD. CYPRUS<br />

PROGESTOGEL 1 POUR CENT GEL N/A BESINS INTERNATIONAL FRANCE<br />

PROGRAF CAPSULES 1MG HIKMA<br />

PHARMACEUTICALS<br />

PROGRAF CAPSULES 5MG HIKMA<br />

PHARMACEUTICALS<br />

JORDAN<br />

JORDAN<br />

PROGYLUTON COATED TABLET N/A SCHERING AG GERMANY<br />

PROGYNOVA 2MG TABLET COATED TABLET 2MG SCHERING HEALTH CARE<br />

LTD<br />

PROGYNOVA TS TRANSDERMAL PATCH 3.8MG SCHERING HEALTH CARE<br />

LTD<br />

PROGYNOVA TS FORTE TRANSDERMAL PATCH 7.6MG SCHERING HEALTH CARE<br />

LTD<br />

PROHANCE SOLN FOR I.V INJECTION 2.79.3MG/ML BRACCO S.P.A ITALY<br />

PROHANCE SOLN FOR IV INJECTION 279.3MG/ML BRACCO S.P.A ITALY<br />

PROMENSIL TABLET 200MG NOVOGEN<br />

LABORATORIES PTY LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

PROMETHAZINE TABLETS 25MG REMEDICA LTD. CYPRUS<br />

PROMETHAZINE HCL SYRUP<br />

PLAIN<br />

SYRUP 6.25MG/5ML WYETH-AYERST<br />

LABORATORIES<br />

PROMETHAZINE HCL12.5MG TABLETS 12.5MG WYETH-AYERST<br />

LABORATORIES<br />

PROMETHAZINE<br />

HYDROCHLORIDE<br />

TABLETS 25MG PHARMAMED LTD. MALTA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

PRONESTYL TABLETS 250MG E.R. SQUIBB & SONS LTD UNITED KINGDOM<br />

PRONTOPYRIN PLUS TABLETS N/A HEINRICH MACK NACHF GERMANY<br />

PROPA PH FOAMING FACE WASH FACE WASH N/A DEL LABORATORIES INC. UNITED STATES OF<br />

AMERICA<br />

PROPAFENON ‘GENERICON’ FILM COATED TABLETS 150MG GENERICON PHARMA<br />

GES.M.B.H<br />

AUSTRIA<br />

PROPANTHELINE TABLETS 15MG REMEDICA LTD. CYPRUS<br />

PROPECIA 1MG TABLETS FILM COATED TABLET 1MG MERCK SHARP & DOHME<br />

LIMITED<br />

UNITED KINGDOM<br />

PROPECIA TABLETS TABLET 1MG MERCK & CO. INC UNITED STATES OF<br />

AMERICA<br />

PROPESS PESSARY 10MG CONTROLLED<br />

THERAPEUTICS<br />

(SCOTLAND) LIMITED<br />

PROPESS 10MG VAGINAL PESSARY 10MG CONTROLLED<br />

THERAPEUTICS<br />

(SCOTLAND) LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

682 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PROPESS 10MG PESSARY 10MG CONTROLLED<br />

THERAPEUTICS<br />

(SCOTLAND) LTD.<br />

PROPESS 10MG PESSARY 10MG CONTROLLED<br />

THERAPEUTICS<br />

(SCOTLAND) LIMITED<br />

PROPOFOL EMULSION FOR IV INJ /<br />

INF<br />

PROPOFOL ABBOTT EMULSION FOR IV INJ./<br />

INF.<br />

PROPOFOL-LIPURO 1% (10MG/ML) EMULSION FOR INJ. OR<br />

INFU<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

10MG/ML ABBOTT LABORATORIES UNITED KINGDOM<br />

10MG/ML ABBOTT AG SWITZERLAND<br />

10MG/ML B.BRAUN MELSUNGEN<br />

AG<br />

PROPRANOLO BP 80MG TABLET 80MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

GERMANY<br />

PROPRANOLOL TABLETS 40MG PHARMAMED LTD. MALTA<br />

PROPRANOLOL BP 10MG TABLET 10MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PROPRANOLOL BP 40MG TABLET 40MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

PROPRANOLOL TABLET 40MG TABLET 40MG RAZA MANUFACTURING<br />

BERHAD<br />

PROPYLTHIOURACIL BP TABLET 50MG CP PHARMACEUTICALS<br />

LIMITED<br />

PROPYLTHIOURACIL TABLETS BP<br />

50MG<br />

PROPYLTHIOURACIL TABLETS BP<br />

50MG<br />

TABLETS 50MG CP PHARMACEUTICALS<br />

LTD.<br />

TABLET 50 MG CP PHARMACEUTICALS<br />

LTD<br />

PROSCAR 5MG TABLET 5MG MERCK SHARP & DOHME<br />

B.V.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

PROSPAN COUGH SYRUP SYRUP 0.7G/100ML KARL ENGELHARD GERMANY<br />

PROSPAN HERBAL DROPS DROPS 20MG/ML KARL ENGELHARD GERMANY<br />

PROSTAP SR LEUPROPELIN<br />

ACETATE DEPOT INJ<br />

POWDER FOR INJECTION 3.75MG/VIAL CYANAMID OF GREAT<br />

BRITAIN LTD.<br />

UNITED KINGDOM<br />

PROSTATONIN CAPSULE N/A PHARMATON SA SWITZERLAND<br />

PROSTIN 15M INJECTABLE SOLUTION 0.25MG/ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

PROSTIN E2 CONC. FOR SOL. FOR INJ. 10MG/ML PHARMACIA & UPJOHN<br />

N.V./ S.A.<br />

PROSTIN E2 CONC. FOR SOL. FOR<br />

INF.<br />

1MG/ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

PROSTIN E2 VAGINAL GEL 1MG/3G PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

PROSTIN E2 VAGINAL GEL 2MG/3G PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

PROSTIN E2 VAGINAL TABLETS 3MG PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 683<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PROSTIN VR 0.5MG CONC. FOR SOL. FOR<br />

INF.<br />

PROSULF SOLUTION FOR<br />

INJECTION<br />

PROSULF INJECTION<br />

1%,PROTAMINE SULPHATE<br />

PROTAMINE SULPHATE<br />

INJECTION BP<br />

PROTAMINE SULPHATE<br />

INJECTION BP,50MG/5ML<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

PROTAMINE SULPHATE LEO SOLUTION FOR<br />

INJECTION<br />

0.5MG/ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

10MG/ML CP PHARMACEUTICALS<br />

LTD.<br />

10MG/ML CP PHARMACEUTICALS<br />

LTD<br />

BELGIUM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

50MG/5ML EVANS MEDICAL LIMITED UNITED KINGDOM<br />

10MG/ML CP PHARMACEUTICALS<br />

LTD<br />

10MG/ML LEO PHARMACEUTICAL<br />

PRODUCTS<br />

PROTHIAZINE TABLETS 25MG CTS CHEMICAL<br />

INDUSTRIES<br />

PROTHIAZINE SYRUP 5MG/5ML CTS CHEMICAL<br />

INDUSTRIES<br />

PROTHIAZINE SYRUP SYRUP 5MG/5ML CTS CHEMICAL<br />

INDUSTRIES LTD<br />

PROTOMID TABLET 250MG MACLEODS INDIA<br />

UNITED KINGDOM<br />

DENMARK<br />

ISRAEL<br />

ISRAEL<br />

ISRAEL<br />

PROTOP CAPSULE 20MG PT INTERBAT INDONESIA<br />

PROTOP CAPSULES BOX,<br />

BOTTLE 14<br />

20 MG/CAP PT INTERBAT INDONESIA<br />

PROVERA TABLETS 5MG PHARMACIA N.V. / S.A. BELGIUM<br />

PROVERA TABLETS 100MG PHARMACIA & UPJOHN<br />

S.P.A.<br />

PROVERA TABLETS 100MG PHARMACIA ITALIA SPA ITALY<br />

PROVIRON TABLET 25MG SCHERING AG GERMANY<br />

PROVIRON TABLET 25MG SCHERING PAKISTAN<br />

PROVIRON TABLETS TABLET 25MG SCHERING PAKISTAN<br />

PRO-VIRON TABLETS TABLETS 25MG SCHERING HEALTH CARE<br />

LIMITED<br />

PROVISC OCULAR VISCOELASTIC<br />

SOLN.<br />

10MG/ML S.A. ALCON-COUVREUR<br />

N.V.<br />

ITALY<br />

UNITED KINGDOM<br />

BELGIUM<br />

PROXEN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS<br />

PROXIL 250MG TABLET 250MG CODAL SYNTO LTD CYPRUS<br />

PROZAC CAPSULE 20MG ELI LILLY & COMPANY<br />

LIMITED<br />

PROZAC WKLY DELAYED RELEASE<br />

CAPS<br />

PRURI-MED SKIN CLEANSING<br />

EMULSION<br />

UNITED KINGDOM<br />

90MG ELI LILLY AND COMPANY UNITED STATES OF<br />

AMERICA<br />

N/A PERMAMED AG SWITZERLAND<br />

PSILO-BALSAM N GEL N/A STADA OTC<br />

ARZNEIMITTEL GMBH<br />

PTU TABLETS 50MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

GERMANY<br />

INDIA


EN<br />

684 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PULANIL TABLETS 200MG HANBUL PHARMA KOREA<br />

PULMEX OINTMENT N/A NOVARTIS CONSUMER<br />

HEALTH SA<br />

PULMEX BABY OINTMENT N/A NOVARTIS CONSUMER<br />

HEALTH SA<br />

PULMICORT INHALATION<br />

SUSPENSION<br />

PULMICORT INHALATION<br />

SUSPENSION<br />

PULMICORT AEROSOL FOR<br />

INHALATION<br />

PULMICORT AEROSOL FOR<br />

INHALATION<br />

SWITZERLAND<br />

SWITZERLAND<br />

0.25MG/ML DRACO LAKEMEDEL AB SWEDEN<br />

0.5MG/ML DRACO LAKEMEDEL AB SWEDEN<br />

50MCG/DOSE DRACO LAKEMEDEL AB SWEDEN<br />

200MCG/DOSE DRACO LAKEMEDEL AB SWEDEN<br />

PULMICORT INHALER 50MCG BARRETT HODGSON PAKISTAN<br />

PULMICORT TURBUHALER INHALATION POWDER 100MCG/DOSE DRACO LAKEMEDEL AB SWEDEN<br />

PULMICORT TURBUHALER INHALATION POWDER 200MCG/DOSE DRACO LAKEMEDEL AB SWEDEN<br />

PULMO BAILLY ORAL LIQUID NA DDD LIMITED UNITED KINGDOM<br />

PULMOCIS POWDER FOR INJECTION N/A LABORATOIRES CIS BIO<br />

INTERNATIONAL<br />

PULMOZYME AMPOULE 2.5MG/2.5ML ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

PULMOZYME INHALATION<br />

SOLUTION 1MG/ML<br />

INHALATION SOLUTION 1MG/ML ROCHE PRODUCTS<br />

LIMITED<br />

FRANCE<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

PULSATE TABLETS 150MG SAMI PAKISTAN<br />

PULVO 47 POWDER FOR TOPICAL<br />

APPL.<br />

PULVO 47 NEOMYCIN POWDER FOR TOPICAL<br />

APPL.<br />

PUMP-HEP SOLUTION FOR<br />

INJECTIONS<br />

2.10(7) CU/100G LABORATOIRES<br />

FOURNIER SCA<br />

N/A LABORATOIRES<br />

FOURNIER SCA<br />

1000IU/ML LEO LABORATORIES<br />

LIMITED<br />

FRANCE<br />

FRANCE<br />

PURFALOX CAPSULE 200MG KLEVA LTD GREECE<br />

PURI-NETHOL TABLETS 50MG THE WELLCOME<br />

FOUNDATION LTD.<br />

PURI-NETHOL TABLETS 50MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

PUVADIN 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

PYLORID TABETS 400MG COATED TABLET 400MG GLAXO GROUP LTD UNITED KINGDOM<br />

PYOPEN INJECTION 1G POWDER FOR INJECTION 1G BEECHAM GROUP PLC UNITED KINGDOM<br />

PYOPEN INJECTION 5G POWDER FOR INJECTION 5G BEECHAM GROUP PLC UNITED KINGDOM<br />

PYRALVEX BUCCAL & GINGIVAL<br />

GEL<br />

N/A NORGINE PHARMA FRANCE<br />

PYRALVEX GEL FOR ORAL MUCOSA N/A NORGINE PHARMA FRANCE<br />

PYRALVEX SOLUTION N/A NORGINE LIMITED UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 685<br />

Trade Name Dosage Form Dose MA Holder Country<br />

PYRALVEX GEL N/A NORGINE PHARMA FRANCE<br />

PYRAZINAMIDE TABLETS 500MG PHARMAMED LTD. MALTA<br />

PYRCOST CAPSULE 20MG KLEVA LTD GREECE<br />

PYRCOST SUPPOSITORY 20MG KLEVA LTD GREECE<br />

PYRCOST GEL 0.5% W/W KLEVA LTD. GREECE<br />

PYRIDOXINE HYDROCHLORIDE<br />

50MG TABLETS BP<br />

TABLET 50 MG CP PHARMACEUTICALS<br />

LTD<br />

PYRIDOXINE TABLETS BP 50MG TABLETS 50MG CP PHARMACEUTICALS<br />

LTD.<br />

PYRIDOXINE TABLETS BP 50MG TABLETS 50MG NORTON<br />

PHARMACEUTICALS<br />

LIMITED<br />

PYRIDOXINE-10 TABLET TABLET 10MG CAMDEN INDUSTRIES (M)<br />

SDN. BHD.<br />

QUADRASA POWDER FOR RECTAL<br />

SOL.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

2G NORGINE PHARMA FRANCE<br />

QUIET LIFE TABLETS COATED TABLET N/A G R LANE HEALTH<br />

PRODUCTS LTD<br />

QUINIMAX 125MG SCORED FILM-COATED<br />

TABLET<br />

QUINIMAX 125MG/ML SOLUTION FOR<br />

INJECTION<br />

QUINIMAX 250MG/2ML SOLUTION FOR<br />

INJECTION<br />

N/A SANOFI WINTHROP FRANCE<br />

N/A SANOFI WINTHROP FRANCE<br />

N/A SANOFI WINTHROP FRANCE<br />

QUINIMAX 500MG FILM-COATED TABLET N/A SANOFI WINTHROP FRANCE<br />

QUINIMAX 500MG/4ML SOLUTION FOR<br />

INJECTION<br />

N/A LABORATOIRES SANOFI<br />

WINTHROP<br />

QUININE TABLET 300MG CAMDEN INDUSTRIES(M)<br />

SDN.BHD.<br />

QUININE DIHYDROCHLORIDE SOLUTION FOR<br />

INJECTION<br />

600MG/2ML PHARMAMED<br />

PARENTERALS LTD.<br />

UNITED KINGDOM<br />

FRANCE<br />

MALAYSIA<br />

MALTA<br />

QUININE SULPHATE TABLETS 200MG PHARMAMED LTD. MALTA<br />

QUININE SULPHATE TABLETS 300MG PHARMAMED LTD. MALTA<br />

QUININE SULPHATE 300 TABLETS 300MG REMEDICA LTD CYPRUS<br />

QUININE SULPHATE BP 300MG TABLET 300MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

QUININE SULPHATE TABLETS BP<br />

300MG<br />

QUININE SULPHATE TABLETS BP<br />

300MG<br />

TABLETS 300MG CP PHARMACEUTICALS<br />

LTD.<br />

COATED TABLET 300MG CP PHARMACEUTICALS<br />

LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

QUINOCORT CREAM CREAM N/A QUINODERM LIMITED UNITED KINGDOM<br />

QVAR 100 AEROSOL AEROSOL 100MCG 3M HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM


EN<br />

686 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

QVAR 100 AUTOHALER AEROSOL 100MCG 3M HEALTHCARE<br />

LIMITED<br />

QVAR 50 AEROSOL AEROSOL 50MCG 3M HEALTHCARE<br />

LIMITED<br />

QVAR 50 AUTOHALER AEROSOL 50MCG 3M HEALTHCARE<br />

LIMITED<br />

RABIVAC POWDER FOR SOL. FOR<br />

INJE<br />

N/A CHIRON BEHRING GMBH<br />

&CO<br />

RADIAN B MUSCLE LOTION TOPICAL SOLUTION N/A ROCHE PRODUCTS<br />

LIMITED<br />

RADIAN MASS.CR./ASKIT MUS.<br />

RUB/RADIAN B<br />

CREAM N/A ROCHE PRODUCTS<br />

LIMITED<br />

RALGEX CREAM N/A SETON PRODUCTS<br />

LIMITED<br />

RALGEX FREEZE SPRAY TOPICAL SPRAY N/A SETON PRODUCTS<br />

LIMITED<br />

RALGEX FREEZE SPRAY TOPICAL SPRAY N/A SETON PRODUCTS<br />

LIMITED<br />

RALGEX HEAT RUB CREAM CREAM N/A SETON PRODUCTS<br />

LIMITED<br />

RALGEX HEAT SPRAY TOPICAL SPRAY N/A SETON PRODUCTS<br />

LIMITED<br />

RALGEX LOW ODOUR HEAT<br />

SPRAY<br />

TOPICAL SPRAY N/A SETON PRODUCTS<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

RAMAXIR CAPSULES 250MG REMEDICA LTD. CYPRUS<br />

RANIGYL TABLET 200MG RAZA MANUFACTURING<br />

BERHAD<br />

RANITIDINE COATED TABLET 75MG EASTERN<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

UNITED KINGDOM<br />

RANITIDINE TABLETS BP FILM COATED TABLETS 75MG RANBAXY (UK) LIMITED UNITED KINGDOM<br />

RANITINE FILMCOATED TABLETS 150MG BIOFARMA ILAC SAN.VE<br />

TIC. A.S.<br />

RANIVIT 150 TABLETS 150MG M/S VITAPURE<br />

CORPORATION<br />

RANSOM GLYCERIN, LEMON AND<br />

HONEY LINCTUS<br />

ORAL SOLUTION N/A WILLIAM RANSOM &<br />

SON PLC<br />

RANTAC-150 TABLET 150MG UNIQUE<br />

PHARMACEUTICAL<br />

LABORATORIES<br />

RANTIN TABLETS 150MG MACTER<br />

INTERNATIONAL (PVT)<br />

LTD.<br />

RANTUDIL FORTE CAPSULE 60MG BAYER VITAL GMBH &<br />

CO. KG<br />

TURKEY<br />

INDIA<br />

UNITED KINGDOM<br />

INDIA<br />

PAKISTAN<br />

GERMANY<br />

RANTUDIL FORTE CAPSULES 60MG TROPON GMBH GERMANY<br />

RANTUDIL RETARD CAPSULE 90MG BAYER VITAL GMBH &<br />

CO. KG<br />

GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 687<br />

Trade Name Dosage Form Dose MA Holder Country<br />

RANTUDIL RETARD CAPSULES 90MG TROPON GMBH GERMANY<br />

RAPAMUNE ORAL SOLUTION 1MG/1ML WYETH-AYERST<br />

LABORATORIES<br />

UNITED KINGDOM<br />

RAPAMUNE ORAL SOLUTION 1MG/ML WYETH EUROPA LTD. UNITED KINGDOM<br />

RAPIFEN 0.5MG/ML SOLUTION FOR<br />

INJECTION<br />

0.5MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

RAPOLYTE POWDER N/A HELSINN BIREX<br />

PHARMACEUTICALS LTD.<br />

RAXAR TABLETS 400MG TABLET 400MG GLAXO WELLCOME UK<br />

LTD<br />

RAXAR TABLETS 600MG TABLET 600MG GLAXO WELLCOME UK<br />

LTD<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

RBC CREAM CREAM N/A RYBAR LABS. LIMITED UNITED KINGDOM<br />

REBETOL HARD CAPSULES 200MG SP EUROPE UNITED KINGDOM<br />

REBIF 22MCG SOLUTION FOR<br />

INJECTION<br />

RECOFOL EMULSION FOR<br />

INFUSION<br />

RECOFOL 10MG/ML EMULSION FOR INJEC./<br />

INFUS<br />

RECOMBINANT HUMAN<br />

ERYTHROPOIETIN<br />

RECOMBINANT HUMAN<br />

ERYTHROPOIETIN<br />

RECOMBINANT HUMAN<br />

ERYTHROPOIETIN<br />

RECOMBINANT HUMAN<br />

ERYTHROPOIETIN<br />

RECOMBINATE<br />

ANTIHAEMOPHILIC FACTOR<br />

22MCG/0.5ML ARES SERONO (EUROPE)<br />

LTD.<br />

ITALY<br />

20MG/ML LEIRAS OY FINLAND<br />

10MG/ML LEIRAS OY FINLAND<br />

INJECTION 6000IU/VIAL NANJING HUAXIN BIO-<br />

PHARMACEUTICALS LTD<br />

INJECTION 3000IU/VIAL NANJING HUAXIN BIO-<br />

PHARMACEUTICALS LTD<br />

INJECTION 4000IU/VIAL NANJING HUAXIN BIO-<br />

PHARMACEUTICALS LTD<br />

INJECTION 2000IU/VIAL NANJING HUAXIN BIO-<br />

PHARMACEUTICALS LTD<br />

POWDER FOR INJECTION 250IU/VIAL BAXTER HEALTHCARE<br />

LIMITED<br />

RECOMBINATE RAHF NOMINAL POWDER OR INJECTION 500IU/VIAL BAXTER HEALTHCARE<br />

LIMITED<br />

RECOMBINATE RAHF NOMINAL<br />

1000IU/VIAL<br />

POWDER FOR INJECTION 1000IU/VIAL BAXTER HEALTHCARE<br />

LIMITED<br />

RECORMON PREFILLED SYRINGES PREFILLED SYRINGES 1000 IU/0.6ML ROCHE<br />

PHARMA(SCHWEIZ) LTD.<br />

RECORMON PREFILLED SYRINGES PREFILLED SYRINGES 4000/6000 IU ROCHE<br />

PHARMA(SCHWEIZ) LTD.<br />

RECORMON PREFILLED SYRINGES PREFILLED SYRINGES 2000/3000/5000 ROCHE<br />

PHARMA(SCHWEIZ) LTD.<br />

RECTODELT 10MG SUPPOSITORY 10MG TROMMSDORFF GMBH &<br />

CO. AG<br />

RECTODELT 30MG SUPPOSITORY 30MG TROMMSDORFF GMBH &<br />

CO. AG<br />

RECTODELT 5MG SUPPOSITORY 5MG TROMMSDORFF GMBH &<br />

CO. KG<br />

REPUBLIC OF CHINA<br />

REPUBLIC OF CHINA<br />

REPUBLIC OF CHINA<br />

REPUBLIC OF CHINA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

GERMANY<br />

GERMANY<br />

GERMANY


EN<br />

688 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

RECTOPLEXIL 3.3MG CHILDREN SUPPOSITORY 3.3MG LABORATOIRES<br />

THERAPLIX<br />

RECTOPLEXIL CHILDREN SUPPOSITORY 3.3MG LABORATOIRES<br />

THERAPLIX<br />

FRANCE<br />

FRANCE<br />

REDUCTIL HARD CAPSULE 10MG ABBOTT LABORATORIES UNITED KINGDOM<br />

REDUCTIL HARD CAPSULE 15MG ABBOTT LABORATORIES UNITED KINGDOM<br />

REFACTO POWDER AND SOLVENT<br />

FOR SOLUTION FOR<br />

INJECTION<br />

REFACTO POWDER AND SOLVENT<br />

FOR SOLUTION FOR<br />

INJECTION<br />

REFACTO POWDER AND SOLVENT<br />

FOR SOLUTION FOR<br />

INJECTION<br />

250IU GENETICS INSTITUTE OF<br />

EUROPE B.V.<br />

500IU GENETICS INSTITUTE OF<br />

EUROPE B.V.<br />

1000IU GENETICS INSTITUTE OF<br />

EUROPE B.V.<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

REFRESH PLUS LUBRICANT EYE DROPS 0.5% W/V ALLERGAN UNITED STATES OF<br />

AMERICA<br />

REGAINE 2% CUTANEOUS SOLUTION 20MG/ML PHARMACIA N.V./S.A. BELGIUM<br />

REGAINE 2% GEL 20MG/G PHARMACIA & UPJOHN<br />

N.V / S.A<br />

BELGIUM<br />

REGAINE 5% CUTANEOUS SOLUTION 5% W/V PHARMACIA N.V. / S.A. BELGIUM<br />

REGAINE EXTRA STRENGTH 5% TOPICAL SOLUTION 5% PHARMACIA LIMITED UNITED KINGDOM<br />

REHIDRAT POWDER FOR ORAL<br />

SOLUTION<br />

REHIDRAT POWDER FOR ORAL<br />

SOLUTION<br />

N/A MONSANTO PLC T/A<br />

SEARLE<br />

UNITED KINGDOM<br />

NA PHARMACIA LIMITED UNITED KINGDOM<br />

RELAXIN TABLETS 3MG MACTER<br />

INTERNATIONAL (PVT)<br />

LTD.<br />

RELENZA 5MG/DOSE POWDER FOR<br />

INHALATION<br />

RELENZA ROTADISK INSUFFLATION BLISTER<br />

PACK<br />

5MG/DOSE LABORATOIRE GLAXO<br />

WELLCOME<br />

5MG GLAXO WELLCOME<br />

AUSTRALIA LTD.<br />

PAKISTAN<br />

FRANCE<br />

AUSTRALIA<br />

RELIFEX TABLETS 500MG COATED TABLET 500MG BEECHAM GROUP PLC UNITED KINGDOM<br />

REMEDEINE EFFERVESCENT<br />

TABLETS<br />

REMEDEINE FORTE EFFERVESCENT<br />

TABLETS<br />

EFFERVESCENT TABLET N/A NAPP LABORATORIES<br />

LIMITED<br />

EFFERVESCENT TABLET N/A NAPP LABORATORIES<br />

LIMITED<br />

REMEDEINE FORTE TABLETS TABLET N/A NAPP LABORATORIES<br />

LIMITED<br />

REMEDEINE TABLETS TABLET N/A NAPP LABORATORIES<br />

LIMITED<br />

REMEGEL CHEWABLE TABLET CHEWABLE TABLET 800 MG SETON PRODUCTS<br />

LIMITED<br />

REMEGEL FRESHMINT CHEWABLE TABLET 800 MG SETON PRODUCTS<br />

LIMITED<br />

REMETHAN 25 TABLETS 25MG REMEDICA LTD CYPRUS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 689<br />

Trade Name Dosage Form Dose MA Holder Country<br />

REMETHAN 50 TABLETS 50MG REMEDICA LTD CYPRUS<br />

REMICADE POW.ANDCONC.F/SOL/F/<br />

INF.<br />

SEE REMARKS CENTOCOR B.V. UNITED KINGDOM<br />

REMINYL ORAL SOLUTION 4MG/1ML JANSSEN<br />

PHARMACEUTICA N.V.<br />

REMINYL FILM-COATED TABLETS 8MG JANSSEN CILAG SPA ITALY<br />

REMINYL FILM COATED TABLETS 4MG JANSSEN CILAG SPA ITALY<br />

REMINYL FILM COATED TABLETS 12MG JANSSEN CILAG SPA ITALY<br />

REMOV GRANULE 100MG/SACHET VECCHI & C PIAM<br />

S.A.P.A.<br />

REMOV TABLET 100MG VECCHI & C PIAM<br />

S.A.P.A.<br />

BELGIUM<br />

REMYCIN 100 TABLETS 100MG REMEDICA LTD CYPRUS<br />

RENITEC TABLET 10MG MERCK SHARP & DOHME PAKISTAN<br />

RENITEC TABLET 5MG MSD PAKISTAN<br />

RENITEC TABLET 5MG M.S.D. PAKISTAN<br />

RENITEC 20MG TABLET 20MG MERCK SHARP & DOHME<br />

B.V.<br />

ITALY<br />

ITALY<br />

NETHERLANDS<br />

RENITEC 20MG TABLETS 20MG MSD PAKISTAN<br />

RENITEC 5MG TABLET 5MG MERCK SHARP & DOHME<br />

B.V.<br />

RENNIE CHEWABLE TABLET N/A LABORATOIRES ROCHE<br />

NICHOLAS S.A.<br />

RENNIE DEFLATINE TABLET NS ROCHE PRODUCTS<br />

LIMITED<br />

RENNIE DUO ORAL SUSPENSION NS ROCHE PRODUCTS<br />

LIMITED<br />

RENNIE PEPPERMINT TABLET N/A ROCHE PRODUCTS<br />

LIMITED<br />

RENNIE RAP-EZE CHEWABLE TABLET 500MG ROCHE PRODUCTS<br />

LIMITED<br />

RENNIE SPEARMINT TABLET NS ROCHE PRODUCTS<br />

LIMITED<br />

REOPRO SOLUTION FOR<br />

INJECTION<br />

NETHERLANDS<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

2MG/ML CENTOCOR B.V. NETHERLANDS<br />

REPARIL GEL N GEL NA MADAUS AG GERMANY<br />

REPLAVITE REHYDRATION<br />

TREATMENT GRANULES<br />

GRANULES N/A SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

REPLENINE, (REPLENIN-VF) POWDER FOR INJECTION N/A BPL, BIO PRODUCTS<br />

LABORATORY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

RESCUE REMEDY (BACH) ORAL LIQUID N/A NELSON A. & CO LTD UNITED KINGDOM<br />

RESCULA EYE DROPS 1.2MG/ML NOVARTIS ARGENTINA<br />

SAICYF<br />

ARGENTINA


EN<br />

690 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

RESCULA EYE DROPS EYE DROPS 1.5MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

RESFOLIN TABLET 15MG VECCHI & C PIAM<br />

S.A.P.A.<br />

RESOVIST O.5 MMOL FE/ML SOLUTION FOR<br />

INJECTION<br />

SWITZERLAND<br />

ITALY<br />

1MG SCHERING AG GERMANY<br />

RETACNYL 0.025% CREAM 0.025% LABORATOIRES<br />

GALDERMA<br />

RETACNYL 0.05% CREAM 0.05% LABORATOIRE<br />

GALDERMA<br />

RETENS CAPSULE 100MG CHIESI WASSERMANN<br />

S.A.<br />

RETENS CAPSULES 116MG CHIESI ESPANA S.A. SPAIN<br />

FRANCE<br />

FRANCE<br />

RETIN A SOLUTION 1.183MG/G JANSSEN-CILAG AG SWITZERLAND<br />

RETIN A 0.025% GEL 0.025% JANSSEN-CILAG AG SWITZERLAND<br />

RETIN A 0.05% CREAM 0.05% JANSSEN-CILAG AG SWITZERLAND<br />

RETITOP 0.05% CREAM 0.05% W/W LABORATOIRES ROCHE-<br />

POSAY<br />

RETROVIR CAPSULES 100MG CAPSULES 100MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

RETROVIR CAPSULES 250MG CAPSULES 250MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

RETROVIR IV FOR INFUSION SOLUTION FOR<br />

INJECTIONS<br />

10MG/ML THE WELLCOME<br />

FOUNDATION LIMITED<br />

RETROVIR SYRUP 50MG/5ML ORAL SOLUTION 50MG/5ML THE WELLCOME<br />

FOUNDATION LIMITED<br />

REVIA TABLETS 50MG DUPONT<br />

PHARMACEUTICALS<br />

COMPANY<br />

REVIDOX TABLET 100MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

RHE FD TABLETS N/A MACLEODS<br />

PHARMACEUTICALS LTD<br />

RHESONATIV POWDER FOR INJECTION (I+II) 1250IU PHARMACIA & UPJOHN<br />

AB<br />

RHESSONATIV 1250 IU POWDER AND SOLVENT 200 MG BIOVITRUM AB<br />

RHEUMASOL TABLETS COATED TABLET N/A PETER BLACK<br />

HEALTHCARE LTD<br />

RHINATHIOL 2% FOR CHILDREN<br />

AND INFANTS<br />

RHINATHIOL 375MG<br />

EXPECTORANT<br />

RHINATHIOL 5% ADULTS<br />

EXPECTORANT<br />

RHINATHIOL ADULTS<br />

SUGER-FREE EXPECTORANT<br />

SYRUP 2% W/V LABORATOIRES<br />

SYNTHELABO<br />

CAPSULE 375MG LABORATOIRES<br />

SYNTHELABO<br />

SYRUP 5% W/V LABORATOIRES<br />

SYNTHELABO<br />

SYRUP 5% W/V LABORATOIRES<br />

SYNTHELABO<br />

SPAIN<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

INDIA<br />

INDIA<br />

SWEDEN<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

FRANCE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 691<br />

Trade Name Dosage Form Dose MA Holder Country<br />

RHINATHIOL PROMETHAZINE SYRUP N/A LABORATOIRES<br />

SYNTHELABO<br />

RHINATHIOL SUGAR-FREE<br />

CHILDREN AND INFANTS<br />

SYRUP 2% W/V LABORATOIRES<br />

SYNTHELABO<br />

RHINOCAP CAPSULE N/A DR.GROSSMANN AG<br />

PHARMACA<br />

FRANCE<br />

FRANCE<br />

SWITZERLAND<br />

RHINOCORT AQUA NASAL SPRAY 50MCG/DOSE TIKA LAKEMEDEL AB SWEDEN<br />

RHINOCORT AQUA NASAL SPRAY 32MCG/DOSE TIKA LAKEMEDEL AB SWEDEN<br />

RHINOCORT AQUA NASAL SPRAY 64MCG/DOSE TIKA LAKEMEDEL AB SWEDEN<br />

RHINOLAST NASAL SPRAY NASAL SPRAY 0.1% W/V ASTA MEDICA LTD UNITED KINGDOM<br />

RHINOPRONT CAPSULES N/A HEINRICH MACK NACHF GERMANY<br />

RHINOPRONT SPRAY SOLUTION N/A HEINRICH MACK GERMANY<br />

RHINOPRONT SYRUP SUSPENSION N/A HEINRICH MACK NACHF GERMANY<br />

RHINOTUSSAL CAPSULES NA HEINRICH MACK NACHF GERMANY<br />

RHINOTUSSAL SYRUP NA HEINRICH MACK NACHF GERMANY<br />

RHUMAGEL GEL N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

RHUMAGEL GEL N/A HOE PHARMACEUTICALS<br />

SDN BHD<br />

RHUMAGEL GEL 0.5% W/W HOE PHARMACEUTICALS<br />

SDN. BHD<br />

RIAMET TABLETS N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

RIBOMICIN OPHTHALMIC OINTMENT 0.3% W/W FARMIGEA SPA ITALY<br />

RIBOMICIN OPHTHALMIC DROPS 0.3% W/V FARMIGEA SPA ITALY<br />

RIFADINE 150MG CAPSULE 150MG LABORATOIRES MARION<br />

MERRELL DOW<br />

RIFADINE 300MG CAPSULE 300MG LABORATOIRES MARION<br />

MERRELL DOW<br />

RIFADINE LYOPHILISEE 600MG PREPARATION FOR<br />

INFUSION<br />

600MG LABORATOIRES MARION<br />

MERRELL DOW<br />

MALAYSIA<br />

MALAYSIA<br />

MALAYSIA<br />

SWITZERLAND<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

RIFAMPICIN FILM COATED TABLETS 300MG PHARMAMED LTD. MALTA<br />

RIFAMPICIN AND ISONIAZID AND<br />

PYRAZINAMIDE<br />

RIFAMPICIN AND ISONIAZID<br />

150/100MG<br />

RIFAMPICIN AND ISONIAZID<br />

150/75MG<br />

RIFAMPICIN AND ISONIAZID<br />

300/150MG<br />

RIFAMPICIN AND ISONOIAZID<br />

AND PYRAZINAMIDE<br />

TABLET 150/75/400MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

TABLET N/A MACLEODS<br />

PHARMACEUTICALS LTD<br />

TABLET N/A MACLEODS<br />

PHARMACEUTICALS LTD<br />

TABLETS N/A MACLEODS<br />

PHARMACEUTICALS LTD<br />

TABLET 120/50/300MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

RIFAMPICIN + ISONIAZID TABLETS 300MG +150MG PHARMAMED LTD. MALTA<br />

INDIA<br />

INDIA<br />

INDIA<br />

INDIA<br />

INDIA


EN<br />

692 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

RIFAREN CAPSULES 300MG REMEDICA LTD. CYPRUS<br />

RIFAREN 150 CAPSULES 150MG REMEDICA LTD CYPRUS<br />

RIFASYNT 150MG CAPSULE 150MG MEDOCHEMIE LTD CYPRUS<br />

RIFASYNT 300MG CAPSULE 300MG MEDOCHEMIE LTD CYPRUS<br />

RIFATER COATED TABLET N/A LABORATOIRES MARION<br />

MERRELL DOW<br />

RIFINAH TABLETS 150MG/100MG GRUPPO LEPETIT SPA ITALY<br />

RIFINAH 300MG/150MG COATED TABLET N/A LABORATOIRES MARION<br />

MERRELL FRANCE<br />

RIKODEINE 9.5MG/5ML ORAL LIQUID 9.5MG/5ML 3M PHARMACEUTICALS<br />

PTY LTD.<br />

FRANCE<br />

FRANCE<br />

AUSTRALIA<br />

RILCAPTON 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS<br />

RILCAPTON 50MG TABLET 50MG MEDOCHEMIE LTD CYPRUS<br />

RILUTEK FILM COATED TABLET 50MG RHONE-POULENC RORER<br />

S.A.<br />

RINGER LACTATED AGUETTANT SOLUTION FOR<br />

INFUSION<br />

RINGERS INJECTION USP SOLUTION FOR<br />

INJECTION<br />

RINGER'S INJECTION USP SOLUTION FOR IV<br />

INFUSION<br />

N/A LABORATOIRE<br />

AGUETTANT<br />

FRANCE<br />

FRANCE<br />

NA ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

N/A ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

RINGER'S IRRIGATION SOLUTION IRRIGATION SOLUTION N/A B.BRAUN MELSUNGEN<br />

AG<br />

RINGERS IV INFUSION SOLUTION FOR<br />

INJECTION<br />

RINGER'S LACTATE (HARTMANN<br />

SOLUTION)<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA<br />

FARMACEUTICA<br />

RINSTEAD ADULT GEL OROMUCOSAL GEL N/A SCHERING-PLOUGH<br />

LIMITED<br />

RINSTEAD CONTACT PASTILLE LOZENGE 2MG SCHERING-PLOUGH<br />

LIMITED<br />

RINSTEAD SUGAR FREE<br />

PASTILLES<br />

LOZENGE N/A SCHERING-PLOUGH<br />

LIMITED<br />

RINSTEAD TEETHING GEL ORAL GEL N/A SCHERING-PLOUGH<br />

LIMITED<br />

RIOPAN PLUS SUS SUSPENSION N/A WYETH-AYERST<br />

CANADA INC.<br />

RISDONE-1 TABLET 1MG INTAS<br />

PHARMACEUTICALS LTD<br />

RISDONE-1 (RISPERIDONE<br />

TABLETS 1MG)<br />

TABLET 1MG INTAS<br />

PHARMACEUTICALS LTD<br />

RISDONE-2 TABLETS 2MG INTAS<br />

PHARMACEUTICALS LTD<br />

RISDONE-2 (RISPERIDONE<br />

TABLETS 2MG)<br />

TABLET 2MG INTAS<br />

PHARMACEUTICALS LTD<br />

GERMANY<br />

UNITED KINGDOM<br />

PORTUGAL<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CANADA<br />

INDIA<br />

INDIA<br />

INDIA<br />

MALAYSIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 693<br />

Trade Name Dosage Form Dose MA Holder Country<br />

RISDONE-3 TABLET 3MG INTAS<br />

PHARMACEUTICALS LTD<br />

RISDONE-3 (RISPERIDONE<br />

TABLETS 3MG)<br />

TABLET 3MG INTAS<br />

PHARMACEUTICALS LTD<br />

RISDONE-4 4MG TABLET INTAS<br />

PHARMACEUTICALS LTD<br />

RISDONE-4 (RISPERIDONE<br />

TABLETS 4MG)<br />

TABLET 4MG INTAS<br />

PHARMACEUTICALS LTD<br />

INDIA<br />

MALAYSIA<br />

RISPERDAL 1MG TABLET 1MG JANSSEN-CILAG N.V. BELGIUM<br />

RISPERDAL 1MG/ML ORAL SOLUTION 1MG/ML JANSSEN-CILAG AG BELGIUM<br />

RISPERDAL 2MG TABLET 2MG JANSSEN-CILAG N.V. BELGIUM<br />

RISPERDAL 3MG TABLET 3MG JANSSEN-CILAG N.V. BELGIUM<br />

RITALIN TABLETS 10MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

RITALIN TABLETS 10MG NOVARTIS PHARMA<br />

GMBH<br />

RITOSIN FILM TABLET 150MG BIOFARMA ILAC SAN VE<br />

TIC A.S.<br />

RIVOTRIL TABLETS 0.5MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

RIVOTRIL TABLET 2MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

ROACCUTANE CAPSULES 2.5MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

ROACCUTANE CAPSULES 10MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

ROACCUTANE CAPSULE 20MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

INDIA<br />

INDIA<br />

SWITZERLAND<br />

GERMANY<br />

TURKEY<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

ROACCUTANE 10MG CAPSULE 10MG PRODUITS ROCHE FRANCE<br />

ROACCUTANE 20MG CAPSULE 20MG PRODUITS ROCHE FRANCE<br />

ROACCUTANE 5MG CAPSULES 5MG PRODUITS ROCHE FRANCE<br />

ROBITUSSIN SYRUP 100MG/5ML WHITEHALL<br />

INTERNATIONAL INC<br />

ROBITUSSIN DM SYRUP N/A WHITEHALL<br />

INTERNATIONAL INC.<br />

ROBITUSSIN DM SYRUP SYRUP NS WYETH CONSUMER<br />

HEALTHCARE<br />

ROBITUSSIN PAEDIATRIC COUGH SYRUP 7.5MG/5 ML WYETH CONSUMER<br />

HEALTHCARE<br />

ROBITUSSIN PE SYRUP N/A WHITEHALL<br />

INTERNATIONAL INC.<br />

ROBITUSSIN PE SYRUP SYRUP NA WYETH CONSUMER<br />

HEALTHCARE<br />

ROCEPHIN ROCHE VIAL 2G ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

SWITZERLAND


EN<br />

694 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ROCEPHIN VIALS 250MG (I.M.) STERILE POWDER FOR<br />

RECONS<br />

ROCEPHIN VIALS 500MG (I.V.) STERILE POWDER FOR<br />

RECON.<br />

ROCEPHINE 1G/10ML (IV USE) POWDER AND SOLVENT<br />

F. INJ.<br />

ROCEPHINE 1G/3.5ML (IM USE) POWDER AND SOLVENT<br />

F. INJ<br />

ROCEPHINE 250MG/5ML (IV USE) POWDER AND SOLVENT<br />

F. INJ.<br />

ROCEPHINE 2G POWDER F SOLN F<br />

INFUSION<br />

ROCEPHINE 500MG/5ML (IV USE) POWDER AND SOLVENT<br />

F. INJ.<br />

ROCEPHINE VIALS 1G I.M. / I.V. STERILE POWDER FOR<br />

RECONS<br />

250MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

500MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

SWITZERLAND<br />

SWITZERLAND<br />

1G/10ML PRODUITS ROCHE FRANCE<br />

1G/3.5ML PRODUITS ROCHE FRANCE<br />

250MG/5ML PRODUITS ROCHE FRANCE<br />

2G PRODUITS ROCHE FRANCE<br />

500MG/5ML PRODUITS ROCHE FRANCE<br />

1G ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

SWITZERLAND<br />

RODOGYL FILM COATED TABLET N/A RHONE-POULENC RORER FRANCE<br />

ROFERON-A VIAL SEE CPP ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

ROKAMOL 500MG CAPLETS CAPLET 500MG TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

SWITZERLAND<br />

ISRAEL<br />

ROPRIL AEGIS LTD. 12.5MG AEGIS LTD CYPRUS<br />

ROPRIL 25 TABLETS 25MG AEGIS LTD. CYPRUS<br />

ROPRIL 50 TABLETS 50MG AEGIS LTD. CYPRUS<br />

ROR, TRIMOVAX, TRIMOVAX<br />

MERIEUX<br />

SOLUTION FOR<br />

INJECTION<br />

N/A PASTEUR MERIEUX<br />

SERUMS & VACCINS<br />

LABORATORIES<br />

FRANCE<br />

ROVAMYCIN 1.5M IU FILM-COATED TABLETS 1.50 MILLION IU SPECIA LABORATORIES FRANCE<br />

ROVAMYCINE FILM-COATED TABLETS 3 MILLION IU RHONE-POULENC RORER FRANCE<br />

ROVAMYCINE FILM-COATED TABLETS 1.5 MILLION IU RHONE-POULENC RORER FRANCE<br />

ROVAMYCINE 3 MILLION IU FILM-COATED TABLETS N/A SPECIA LABORATORIES FRANCE<br />

ROVAMYCINE CHILDREN 0.75MIU GRANULES FOR ORAL<br />

SUSPENS<br />

0.75MIU RHONE-POULENC RORER<br />

PHARMASPECIALITES<br />

ROWATANAL CREAM N/A ROWA<br />

PHARMACEUTICALS LTD<br />

ROXAID TABLET 150MG UNIMED<br />

PHARMACEUTICALS INC.<br />

ROXAMED TABLETS 150MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

FRANCE<br />

IRELAND<br />

KOREA REPUBLIC<br />

JORDAN<br />

ROXITAN 10 CAPSULES 10MG REMEDICA LTD CYPRUS<br />

ROXY — 150 TABLET 150MG CIPLA LTD INDIA<br />

ROZEX GEL FOR CUTANEOUS<br />

USE<br />

0.75% W/W LABORATOIRES<br />

GALDERMA<br />

FRANCE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 695<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ROZEX CREAM 0.75% W/W GALDERMA(UK) LIMITED UNITED KINGDOM<br />

ROZEX CREAM CREAM 0.75%W/W GALDERMA (UK) LIMITED UNITED KINGDOM<br />

ROZEX GEL GEL 0.75% W/W GALDERMA (UK) LIMITED UNITED KINGDOM<br />

RPR SULPHADIAZINE SOLUTION FOR<br />

INJECTION<br />

27.2% W/V CONCORD<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

RREDENEMA RECTAL SOLUTION 0.2MG/ML PHARMAX LIMITED UNITED KINGDOM<br />

RUBELLA VACCINE LIVE B.P.<br />

LYOPHILISED<br />

FREEZE-DRIED CAKE F/<br />

INJ<br />

1000 CCID50 M/S SERUM INSTITUTE<br />

OF INDIA<br />

RUBILIN RUBELLA VACCINE FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

RUBIMYCIN TABLET 250MG PHARMACARE LIMITED SOUTH AFRICA<br />

RUDIVAX SOLUTION FOR<br />

INJECTION<br />

INDIA<br />

N/A PASTEUR MERIEUX FRANCE<br />

RUDOLAC SYRUP 7G/10ML G.STREULI & CO. AG SWITZERLAND<br />

RULID TABLET 150MG HOECHST MARION<br />

ROUSSEL<br />

PAKISTAN<br />

RULID 100MG COATED TABLET 100MG LABORATOIRES AVENTIS FRANCE<br />

RULID 100MG TABLET 100MG HOECHST MARION<br />

ROUSSEL<br />

PAKISTAN<br />

RULID 150MG TABLET 150MG LABORATOIRES AVENTIS FRANCE<br />

RULID 150MG TABLET 150MG HOECHST MARION<br />

ROUSSEL<br />

RULID 50MG TABLET FOR ORAL<br />

SUSPEN.<br />

PAKISTAN<br />

50MG LABORATOIRES AVENTIS FRANCE<br />

RUMAFEN-400 TABLETS 400MG ATCO LABORATORIES<br />

(PVT) LTD<br />

RUMAFEN-600 TABLETS 600MG ATCO LABORATORIES<br />

(PVT) LTD<br />

RUMAFEN-600 SUSPENSION 100MG/5ML ATCO LABORATORIES<br />

(PVT) LTD<br />

RUMAFEN-600 GEL 10G/100G ATCO LABORATORIES<br />

(PVT) LTD<br />

PAKISTAN<br />

PAKISTAN<br />

PAKISTAN<br />

PAKISTAN<br />

RUPAN 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS<br />

RUSYDE TABLETS 20MG CP PHARMACEUTICALS<br />

LTD.<br />

RUSYDE TABLETS 40MG CP PHARMACEUTICALS<br />

LTD.<br />

RUVOMINOX INJECTABLE SOLUTION 75MG/3ML RAFARM GREECE<br />

RYNACROM 2% NASAL SPRAY OR<br />

RESISTON TWO<br />

RYNACROM 2% NASAL SPRAY OR<br />

RESTINON TWO<br />

NASAL SPRAY 2%W/V FISONS LTD T/A RHONE<br />

POULENC RORER<br />

NASAL SPRAY 2% W/V FISONS LTD. T/A RHONE<br />

POULENC RORER<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

RYNACROM 4% NASAL SPRAY NASAL SPRAY 4% W/V FISONS LIMITED UNITED KINGDOM<br />

RYNACROM 4% NASAL SPRAY NASAL SPRAY 4%W/V FISONS LTD UNITED KINGDOM


EN<br />

696 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

RYNACROM COMPOUND NASAL SPRAY N/A FISONS LIMITED T/A<br />

RHONE-POULENC RORER<br />

RYNACROM COMPOUND NASAL SPRAY(AEROSOL) N/A FISONS LTD T/A RHONE-<br />

POULENC RORER<br />

RYNACROM NASAL DROPS NASAL DROPS 2%W/V FISONS LTD T/A RHONE-<br />

POULENC RORER<br />

RYNACROM NASAL<br />

DROPS/NASAL SPRAY<br />

NASAL DROPS 2% W/V FISONS LIMITED T/A<br />

RHONE POULENC RORER<br />

RYTHMODAN CAPSULES 100MG CAPSULE 100MG HOECHST MARION<br />

ROUSSEL LIMITED<br />

RYTHMODAN INJECTION<br />

50MG/5ML<br />

SOLUTION FOR<br />

INJECTION<br />

50MG/5ML ROUSSEL<br />

LABORATORIES LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

S.C.R. CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM<br />

SABRIL 500MG TABLET 500MG LABORATOIRES MARION<br />

MERRELL S.A.<br />

SACCA CLEAR-FLEX 2000ML SOLUTION FOR DIALYSIS NA BIEFFE MEDITAL S.P.A. ITALY<br />

SACCA CLEAR-FLEX 2000ML SOLUTION FOR DIALISYS N/A BIEFFE MEDITAL SPA ITALY<br />

SALAMOL EASI-BREATHE INHALER 0.1MG/DOSE NORTON HEALTHCARE<br />

LIMITED<br />

SALAMOL EASI-BREATHE<br />

CFC-FREE<br />

SALAMOL STERI-NEB 2.5MG SOLUTION FOR<br />

NEBULISER<br />

SALAMOL STERI-NEB 5MG SOLUTION FOR<br />

NEBULISATION<br />

INHALER, AERSOSOL 100MCG/DOSE NORTON HEALTHCARE<br />

LIMITED<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

2.5MG/2.5ML STERIPAK LIMITED UNITED KINGDOM<br />

5MG/2.5ML STERIPAK LIMITED UNITED KINGDOM<br />

SALAZOPYRIN TABLETS 500MG PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

SALAZOPYRIN SUPPOSITORIES 500MG PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

SWEDEN<br />

SWEDEN<br />

SALAZOPYRIN EN GASTRO-RESIS. TABLETS 500MG PHARMACIA & UPJOHN SWEDEN<br />

SALAZOPYRIN ENEMA RECTAL SOLUTION 3%W/V PHARMACIA<br />

LABORATORIES LIMITED<br />

SALBUTAMOL AEROSOL INHALATION 0.1MG/DOSE NORTON HEALTHCARE<br />

LIMITED<br />

SALBUTAMOL TABLETS 4MG PHARMAMED LTD. MALTA<br />

SALBUTAMOL TABLETS 4MG REMEDICA LTD. CYPRUS<br />

SALBUTAMOL 2 TABLETS 2MG REMEDICA LTD CYPRUS<br />

SALBUTAMOL SYRUP ORAL SYRUP 2MG/5ML EGYPTIAN<br />

INTERNATIONAL<br />

PHARMACEUTICAL<br />

INDUSTRIES CO (EIPICO)<br />

SALINE STERI-NEB 0.9%W/V SOLUTION (SEE<br />

REMARKS)<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

EGYPT<br />

22.5MCG/2.5ML STERIPAK LIMITED UNITED KINGDOM<br />

SALIPAX CAPSULES 20MG MEPHA PHARMA AG SWITZERLAND<br />

SALMOL CFC-FREE INHALER INHALER 29.64MG NOTRON HEALTHCARE<br />

LTD<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 697<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SALOFALK SUPPOSITORIES 250MG DR. FALK PHARMA<br />

GMBH<br />

SALOFALK ENTERIC COATED<br />

TABLETS<br />

SALOFALK ENTERIC-COATED<br />

TABLETS<br />

500MG DR. FALK PHARMA<br />

GMBH<br />

GERMANY<br />

GERMANY<br />

250MG DR. FALK PHARM GMBH GERMANY<br />

SALOFALK ENEMAS 4G/60ML DR. FALK PHARMA<br />

GMBH<br />

SAMIXON 500 IV POWDER FOR INJECTION 500MG/VIAL HIKMA<br />

PHARMACEUTICALS<br />

SANDA-100 CAPSULE 100MG OKASA PHARMA PVT<br />

LTD INDIA<br />

SANDA-25 CAPSULE 25MG OKASA PHARMA PVT.<br />

LTD — INDIA<br />

GERMANY<br />

JORDAN<br />

SANDIMMUM CAPSULES 100MG NOVARTIS PAKISTAN<br />

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 10MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SANDIMMUN NEORAL ORAL SOLUTION 100MG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 100MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 25MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 50MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SANDIMMUN NEORAL ORAL SOLUTION 100MG/ML NOVARTIS<br />

FARMACEUTICA S.A<br />

SANDIMMUN NEORAL CAPSULES 100MG NOVARTIS<br />

FARMACEUTICA S.A<br />

SANDIMMUN NEORAL CAPSULES 25MG NOVARTIS<br />

FARMACEUTICA S.A<br />

SANDOMIGRAN TABLETS 0.5MG NOVARTIS PHARMA<br />

SCHWEIZ<br />

SANDOSTATIN SOLUTION FOR<br />

INJECTION<br />

SANDOSTATIN SOLUTION FOR<br />

INJECTION<br />

SANDOSTATIN SOLUTION FOR<br />

INJECTION<br />

SANDOSTATIN SOLUTION FOR<br />

INJECTION<br />

SANDOSTATIN SOLUTION FOR<br />

INJECTION<br />

SANDOSTATIN SOLUTION FOR<br />

INJECTION<br />

SANDOSTATIN SOLUTION FOR<br />

INJECTION<br />

0.1MG/ML NOVARTIS<br />

FARMACEUTICA S.A<br />

1MG/5ML NOVARTIS<br />

FARMACEUTICA S.A<br />

1MG/5ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

0.05MG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

0.5MG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

100MCG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

0.05MG/ML NOVARTIS<br />

FARMACEUTICA S.A<br />

INDIA<br />

INDIA<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SPAIN<br />

SPAIN<br />

SPAIN<br />

SWITZERLAND<br />

SPAIN<br />

SPAIN<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SANDOSTATIN LAR MICROSPHERES FOR INJ. 10MG NOVARTIS PHARMA AG SWITZERLAND<br />

SPAIN


EN<br />

698 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SANDOSTATIN LAR MICROSPHERES FOR INJ. 20MG NOVARTIS PHARMA AG SWITZERLAND<br />

SANDOSTATIN LAR MICROSPHERES FOR INJ. 30MG NOVARTIS PHARMA AG SWITZERLAND<br />

SANDOSTATIN LAR POWDER FOR INJECTION 20MG NOVARTIS<br />

FARMACEUTICA S.A.<br />

SANDOSTATIN LAR POWDER FOR INJECTION 10MG NOVARTIS<br />

FARMACEUTICA S.A<br />

SANDOSTATIN LAR POWDER FOR INJECTION 30MG NOVARTIS<br />

FARMACEUTICA S.A<br />

SANDOSTATINA SOLUTION FOR<br />

INJECTION<br />

0.5MG/ML NOVARTIS FARMA —<br />

PRODUTOS<br />

FARMACEUTICOS S.A.<br />

SANTE CAPSULES CAPSULES 20 MG MACTER<br />

INTERNATIONAL (PVT)<br />

SPAIN<br />

SPAIN<br />

SPAIN<br />

PORTUGAL<br />

PAKISTAN<br />

SAROTEN TABLET 10MG H. LUNDBECK A/S DENMARK<br />

SAROTEN TABLET 25MG H.LUNDBECK A/S DENMARK<br />

SASTID SOAP SOAP N/A STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

SAUBASIN TABLETS 60MG KLEVA LTD GREECE<br />

SAVENTRINE IV SOLUTION FOR<br />

INJECTION<br />

SAVOY COLD AND FLU RELIEF<br />

TABLETS<br />

UNITED KINGDOM<br />

2MG/2ML PHARMAX LIMITED UNITED KINGDOM<br />

COATED TABLETS N/A NORMA CHEMICALS<br />

LIMITED<br />

SCHERIPROCT-SALBE OINTMENT N/A SCHERING WIEN<br />

GESELLSCHAFT M.B.H.<br />

SCHOLL ANTISEPTIC FOOT BALM CREAM N/A SCHOLL CONSUMER<br />

PRODUCTS<br />

SCHOLL ATHLETES FOOT TOPICAL POWDER 1% W/W SCHOLL CONSUMER<br />

PRODUCTS<br />

SCHOLL ATHLETE'S FOOT CREAM CREAM 1%W/W SCHOLL CONSUMER<br />

PRODUCTS<br />

SCHOLL ATHLETES FOOT SPRAY<br />

LIQUID<br />

TOPICAL SPRAY 1%W/W SCHOLL CONSUMER<br />

PRODUCTS<br />

SCHOLL CALLOUS REMOVERS PLASTER 40%W/W SCHOLL CONSUMER<br />

PRODUCTS<br />

SCHOLL CORN AND CALLOUS<br />

REM. LIQ.<br />

SCHOLL VERRUCA REMOVAL<br />

SYSTEM<br />

SCOT-TUSSIN ALLERGY<br />

SUGAR-FREE<br />

SCOT-TUSSIN DM COUGH<br />

CHASERS<br />

TOPICAL SOLUTION N/A SCHOLL CONSUMER<br />

PRODUCTS<br />

PLASTER 40%W/W SCHOLL CONSUMER<br />

PRODUCTS<br />

LIQUID 12.5MG/5ML SCOT-TUSSIN<br />

PHARMACAL CO., INC.<br />

LOZENGE 5MG SCOT-TUSSIN<br />

PHARMACAL CO INC<br />

SCOT-TUSSIN DM SUGAR-FREE LIQUID N/A SCOT-TUSSIN<br />

PHARMACAL CO., INC.<br />

SCOT-TUSSIN EXPECTORANT<br />

SUGAR-FREE<br />

LIQUID 200MG/10ML SCOT-TUSSIN<br />

PHARMACAL CO., INC.<br />

UNITED KINGDOM<br />

AUSTRIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 699<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SCOT-TUSSIN ORIGINAL S-F COLD<br />

AND ALLERGY<br />

SCOT-TUSSIN SENIOR<br />

SUGAR-FREE<br />

SEAL AND HEAL VERRUCA<br />

REMOVAL GEL<br />

LIQUID N/A SCOT-TUSSIN<br />

PHARMACAL CO., INC.<br />

LIQUID N/A SCOT-TUSSIN<br />

PHARMACAL CO., INC.<br />

GEL N/A SCHOLL CONSUMER<br />

PRODUCTS LIMITED<br />

SEDOXIL PILLS 1MG MEDIBIAL — PRODUTOS<br />

MEDICOS E<br />

FARMACEUTICOS, S.A.<br />

SEDOXIL TABLET NA LABORATORIOS BIAL —<br />

PORTELA & CA, S.A.<br />

SEDOXIL TABLET 1MG MEDIBIAL — PRODUTOS<br />

MEDICOS E<br />

FARMACEUTICOS S.A.<br />

SEFAGEN SOLUTION FOR<br />

INJECTION<br />

1G BILIM ILAC SANAYII VE<br />

TICARET AS<br />

SEKROL SYRUP NA BILIM ILAC SANAYII VE<br />

TICARET AS<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

PORTUGAL<br />

PORTUGAL<br />

PORTUGAL<br />

TURKEY<br />

TURKEY<br />

SELECIM TABLETS 5MG CIMEX AG SWITZERLAND<br />

SELECTOL 200MG TABLET 200MG RORER<br />

PHARMACEUTICALS LTD.<br />

(T/A RHONE POULENC<br />

RORER)<br />

SELEGELINE HYDOCHLORIDE TABLETS 10MG NORTON HEALTHCARE<br />

LIMITED<br />

SELEGELINE HYDROCHLORIDE TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

SELEGILENE HCL TABLETS 5MG TEVA PHARMACEUTICAL<br />

INDUSTRIES LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ISRAEL<br />

SELEGOS 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

SELEMYCIN 100MG/2ML LIQUID FOR INJECTION 100MG/2ML MEDOCHEMIE LTD CYPRUS<br />

SELEMYCIN 250MG/2ML LIQUID FOR INJECTION 250MG/2ML MEDOCHEMIE LTD CYPRUS<br />

SELEMYCIN 500MG/2ML LIQUID FOR INJECTION 500MG/2ML MEDOCHEMIE LTD CYPRUS<br />

SELERIN TABLETS 5MG CIPLA LTD INDIA<br />

SELEXID TABLETS 200MG LEO PHARMACEUTICAL<br />

PRODUCTS<br />

SELEXID POWDER FOR INJECTION 400G/VIAL LEO PHARMACEUTICAL<br />

PRODUCTS<br />

SELGIN TABLETS 5MG INTAS<br />

PHARMACEUTICALS LTD.<br />

SELSUN SHAMPOO 2.5%W/V ABBOTT LABORATORIES<br />

LIMITED<br />

SEMPREX CAPSULES 8MG THE WELLCOME<br />

FOUNDATION LTD.<br />

DENMARK<br />

DENMARK<br />

SENNA 7.5 TABLETS 7.5MG REMEDICA LTD CYPRUS<br />

SENNA 7.5MG TABLET 7.5MG MEDOCHEMIE LTD CYPRUS<br />

INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

700 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SENOKOT SYRUP ORAL SOLUTION 0.18% W/W RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

SENOKOT TABLETS TABLET 7.5MG RECKITT & COLMAN<br />

PRODUCTS LIMITED<br />

SEPCEN TABLETS 500MG LABORATOIRES<br />

CENTRUM<br />

SEPCEN TABLETS 250MG LABORATOIRES<br />

CENTRUM<br />

SEPCEN 250 TABLETS 250MG ESPECIALIDADES<br />

FARMACEUTICAS<br />

CENTRUM SA<br />

SEPCEN 500 TABLETS 500MG ESPECIALIDADES<br />

FARMACEUTICAS<br />

CENTRUM SA<br />

SEPTANEST WITH ADRENALINE SOLUTION FOR<br />

INJECTION<br />

SEPTANEST WITH ADRENALINE SOLUTION FOR<br />

INJECTION<br />

1/200,000 LABORATOIRES<br />

SEPTODENT<br />

1/100,000 LABORATOIRES<br />

SEPTODONT<br />

SEPTI-AID OINTMENT 10%W/W RAZA MANUFACTURING<br />

BERHAD<br />

SEPTOPAL CHAIN 30 BEADS ON CHAIN N/A MERCK BIOMATERIAL<br />

GMBH<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SPAIN<br />

SPAIN<br />

SPAIN<br />

SPAIN<br />

FRANCE<br />

FRANCE<br />

MALAYSIA<br />

GERMANY<br />

SEPTRA INJ. SOL. FOR INFUSION N/A GLAXO SMITHKLINE INC. CANADA<br />

SEPTRA TABLETS NA GLAXOSMITHKLINE INC CANADA<br />

SEPTRA DS TABLETS NA GLAXOSMITHKLINE INC CANADA<br />

SEPTRIN TABLETS N/A THE WELLCOME<br />

FOUNDATION LTD.<br />

SEPTRIN DISPERSIBLE TABLETS N/A THE WELLCOME<br />

FOUNDATION LTD.<br />

SEPTRIN PAEDIATRIC SUSPENSION NA GLAXO WELLCOME<br />

GMBH & CO.<br />

SEPTRIN TABLETS NA THE WELLCOME<br />

FOUNDATION LIMITED<br />

SEPTRIN ADULT SUSPENSION SUSPENSION N/A THE WELLCOME<br />

FOUNDATION LTD.<br />

SEPTRIN FOR INFUSION SOLUTION FOR<br />

INJECTION<br />

SEPTRIN FORTE (DOUBLE<br />

STRENGTH)<br />

N/A THE WELLCOME<br />

FOUNDATION LIMITED<br />

TABLETS N/A THE WELLCOME<br />

FOUNDATION LTD.<br />

SEPTRIN FORTE TABLETS TABLETS NA THE WELLCOME<br />

FOUNDATION LIMITED<br />

SEPTRIN PAEDIATRIC SUSPENSION N/A THE WELLCOME<br />

FOUNDATION LTD.<br />

SEPTRIN TABLETS ADULT TABLETS NA THE WELLCOME<br />

FOUNDATION LIMITED<br />

SEPTRIN TABLETS FORTE TABLETS NA GLAXOSMITHKLINE<br />

GMBH & Co<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 701<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SERENACE TABLET 1.5MG NORTON HEALTHCARE<br />

LIMITED<br />

SERENACE TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

SERENACE TABLET 10MG NORTON HEALTHCARE<br />

LIMITED<br />

SERENACE CAPSULE 500MCG NORTON HEALTHCARE<br />

LIMITED<br />

SERENACE CAPSULES 0.5MG NORTON HEALTHCARE<br />

LIMITED<br />

SERENACE TABLETS 1.5MG NORTON HEALTHCARE<br />

LIMITED<br />

SERENACE TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

SERENITY TABLETS COATED TABLET N/A CATHAY OF<br />

BOURNEMOUTH LTD<br />

SERETIDE 100 DISKUS INHALATION POWDER N/A GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

SERETIDE 100 DISKUS INHALATION POWDER<br />

PRE-DISPENSED<br />

SERETIDE 125 EVOHALER PRESS. INHAL.,<br />

SUSPENSION<br />

SERETIDE 125 EVOHALER PRESSURISED<br />

INHALATION<br />

NA ALLEN & HANDBURY'S<br />

LIMITED<br />

N/A GLAXO WELLCOME UK<br />

LIMITED<br />

NA GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

SERETIDE 250 DISKUS INHALATION POWDER N/A GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

SERETIDE 250 DISKUS INHALATION POWDER<br />

PRE-DISPENSED<br />

SERETIDE 250 EVOHALER PRESS. INHAL.,<br />

SUSPENSION<br />

NA ALLEN & HANDBURY'S<br />

LIMITED<br />

N/A GLAXO WELLCOME UK<br />

LIMITED<br />

SERETIDE 250 EVOHALER PRESSURED INHALATION NA GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

SERETIDE 50 EVOHALER PRESS. INHAL.,<br />

SUSPENSION<br />

SERETIDE 50 EVOHALER PRESSURISED<br />

INHALATIONS<br />

SERETIDE 500 DISKUS INHALATION POWDER<br />

PRE-DISPENSED<br />

N/A GLAXO WELLCOME UK<br />

LIMITED<br />

NA GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

NA ALLEN & HANDBURY'S<br />

LIMITED<br />

SERETIDE DISKUS INHALATION POWDER 100MCG GLAXO WELLCOME UK<br />

LIMITED<br />

SERETIDE DISKUS INHALATION POWDER 250MCG GLAXO WELLCOME UK<br />

LIMITED<br />

SERETIDE DISKUS INHALATION POWDER 500MCG GLAXO WELLCOME UK<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

IRELAND<br />

IRELAND


EN<br />

702 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SEREVENT SEE REMARKS 25MCG/DOSE LABORATOIRE<br />

GLAXOSMITHKLINE<br />

SEREVENT INHALER AEROSOL 25MCG/AC GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

FRANCE<br />

UNITED KINGDOM<br />

SEREVENT INHALER INHALER 25MCG GLAXOWELLCOME PAKISTAN<br />

SEREVENT INHALER AEROSOL 25MCG/AC GLAXO WELLCOME UK<br />

LIMITIED T/A ALLEN<br />

AND HANDBURYS<br />

SEREVENT INHALER PRESSURISED<br />

INHALATION<br />

SUSPENSION<br />

25UG/AC GLAXO WELLCOME UK<br />

LIMITED<br />

SEROBID INHALER 200MD INHALER 25MCG CIPLA INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SEROQUEL COATED TABLET 25MG ZENECA LIMITED UNITED KINGDOM<br />

SEROQUEL COATED TABLET 100MG ZENECA LIMITED UNITED KINGDOM<br />

SEROQUEL COATED TABLET 200MG ZENECA LIMITED UNITED KINGDOM<br />

SEROQUEL COATED TABLETS 25MG ZENECA LIMITED UNITED KINGDOM<br />

SEROQUEL COATED TABLETS 100MG ZENECA LIMITED UNITED KINGDOM<br />

SEROQUEL COATED TABLETS 200MG ZENECA LIMITED UNITED KINGDOM<br />

SEROQUEL PATIENT STARTER<br />

PACK<br />

TABLET N/A ZENECA LIMITED UNITED KINGDOM<br />

SEROXAT LIQUID 20MG/10ML ORAL SUSPENSION 2MG/ML SMITHKLINE BEECHAM<br />

PLC<br />

SEROXAT TABLETS 20MG COATED TABLET 20MG SMITHKLINE BEECHAM<br />

PLC<br />

SEROXAT TABLETS 30MG COATED TABLET 30MG SMITHKLINE BEECHAM<br />

PLC<br />

SERVEDOL TABLETS 20MG COATED TABLETS 20MG NAPP LABORATORIES<br />

LIMITED<br />

SERVEDOL TABLETS 50MG COATED TABLETS 50MG 50MG NAPP LABORATORIES<br />

LIMITED<br />

SERZONE TABLETS 50MG BRISTOL-MYERS SQUIBB<br />

COMPANY<br />

SERZONE TABLETS 100MG BRISTOL-MYERS SQUIBB<br />

COMPANY<br />

SERZONE TABLETS 150MG BRISTOL-MYERS SQUIBB<br />

COMPANY<br />

SERZONE TABLETS 200MG BRISTOL-MYERS SQUIBB<br />

COMPANY<br />

SERZONE TABLETS 250MG BRISTOL-MYERS SQUIBB<br />

COMPANY<br />

SERZONE (DUTONIN) TABLETS 100MG BRISTOL-MYERS SQUIBB<br />

S.P.A<br />

SERZONE (DUTONIN) TABLETS 200MG BRISTOL MYERS SQUIBB<br />

S.P.A<br />

SETLERS ANTACID PEPPERMINT TABLETS 500MG STAFFORD MILLER<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

ITALY<br />

ITALY<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 703<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SETLERS ANTACID SPEARMINT TABLETS 500MG STAFFORD MILLER<br />

LIMITED<br />

SETLERS ANTACID-PEPPERMINT TABLET 500MG STAFFORD-MILLER<br />

LIMITED<br />

SETLERS ANTACID-SPEARMINT TABLET 500MG STAFFORD-MILLER<br />

LIMITED<br />

SETLERS WIND-EZE CHEWABLE TABLET 125MG STAFFORD-MILLER<br />

LIMITED<br />

SETLERS WIND-EZE SOFT GEL CAPSULES 125MG STAFFORD MILLER<br />

LIMITED<br />

SETLERS WIND-EZE CHEWABLE TABLETS 125MG STAFFORD MILLER<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SEVEN SEAS COD LIVER OIL ORAL SOLUTION N/A SEVEN SEAS LIMITED UNITED KINGDOM<br />

SEVORANE INHALATION LIQUID 100% V/V ABBOTT LABORATORIES<br />

LIMITED<br />

SEVORANE INHALATION LIQUID 100%V/V ABBOTT LABORATORIES<br />

LIMITED<br />

SEVREDOL ORAL SOLUTION<br />

10MG/5ML<br />

ORAL SOLUTION 10MG/5ML NAPP LABORATORIES<br />

LTD.<br />

SEVREDOL TABLETS 10MG COATED TABLETS 10MG NAPP LABORATORIES<br />

LIMITED<br />

SEVRIN OINTMENT 30% W / W BIOGLAN<br />

LABORATORIES LTD<br />

SGUARDI OPHTHALMIC DROPS 0.01G FARMIGEA SPA ITALY<br />

SI[PROX 250 MG TABLETS TABLETS 250 MG DELTA HF ICELAND<br />

SIBELIUM CAPSULE 5MG JANSSEN-CILAG N.V. BELGIUM<br />

SICCAPOS GEL GEL 2MG/ML URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

SICCAPROTECT EYE DROPS N/A URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

SICORTEN CREAM 0.05% W/W NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SICORTEN PLUS CREAM N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SIFROL TABLETS 0.088MG BOEHRINGER INGELHEIM<br />

INTERNATIONAL GMBH<br />

SIFROL TABLETS 0.18MG BOEHRINGER INGELHEIM<br />

INTERNATIONAL GMBH<br />

SIFROL TABLETS 0.7MG BOEHRINGER INGELHEIM<br />

INTERNATIONAL GMBH<br />

SILOMAT TABLETS 40MG BOEHRINGER INGELHEIM<br />

PHARMA KG<br />

SILVER NITRATE PENCIL 95% PAD MOULDED TOUGHENED<br />

TIP<br />

95% SOLOPORT LIMITED T/A<br />

BRAY HEALTH & LEISURE<br />

SIMCARD-10 TABLET 10MG CIPLA LTD INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

SWITZERLAND<br />

SWITZERLAND<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

UNITED KINGDOM<br />

SIMECO SUSPENSION N/A WYETH-LEDERLE PAKISTAN


EN<br />

704 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SIMLO-10 (SIMVASTATIN TABLETS<br />

USP)<br />

TABLET 10MG IPCA LABORATORIES<br />

LIMITED<br />

SIMPLE EYE OINTMENT BP EYE OINTMENT NO ACTIVE INGR. MARTINDALE<br />

PHARMACEUTICALS LTD<br />

INDIA<br />

UNITED KINGDOM<br />

SIMULECT POWDER FOR INJECTION 20MG/VIAL NOVARTIS PHARMA AG SWITZERLAND<br />

SIMULECT (INJECTION)<br />

LYOPHILISATE<br />

20MG/ VIAL NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SIMULECT SEE REMARKS 4MG/ML NOVARTIS EUROPHARM<br />

LIMITED<br />

SWITZERLAND<br />

SIMVACOR TABLETS 10MG KLEVA LTD GREECE<br />

SIMVAKOL FILM TABLET 10MG NOBEL ILAC SANAYII VE<br />

TICARET A.S.<br />

SIMVOR 10MG TABLETS 10MG RANBAXY LABS LTD INDIA<br />

SINECOD DROPS FOR CHILDREN 5MG/ML NOVARTIS CONSUMER<br />

HEALTH SA<br />

SINECOD SYRUP 15MG/10ML NOVARTIS CONSUMER<br />

HEALTH SA<br />

SINEMET 110MG TABLET N/A MERCK SHARP & DOHME<br />

B.V.<br />

SINEMET 25/250 TABLETS 25/250MG MERCK SHARP & DOHME<br />

B.V.<br />

SINEMET CR 250MG TABLETS 250MG MERCK SHARP & DOHME<br />

B.V.<br />

EUROPEAN COMMUNITY<br />

TURKEY<br />

SWITZERLAND<br />

SWITZERLAND<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

SINEQUAN CAPSULE 50MG PFIZER LIMITED UNITED KINGDOM<br />

SINEQUAN CAPSULE 25MG PFIZER LIMITED UNITED KINGDOM<br />

SINEQUAN CAPSULE 10MG PFIZER LIMITED UNITED KINGDOM<br />

SINEQUAN CAPSULE 75MG PFIZER LIMITED UNITED KINGDOM<br />

SINGULAIR CHEWABLE TABLETS 4MG MERCK SHARP & DOHME<br />

LTD.<br />

NETHERLANDS<br />

SINGULAIR 10MG TABLETS COATED TABLET 10MG MERCK SHARP & DOHME UNITED KINGDOM<br />

SINGULAIR PAEDIATRIC 5MG CHEWABLE TABLET 5MG MERCK SHARP & DOHME UNITED KINGDOM<br />

SINUFED SYRUP 30MG/5ML TRIMA ISRAEL<br />

PHARMACEUTICAL<br />

PRODUCTS LTD<br />

ISRAEL<br />

SINUTAB TABLET N/A PARKE-DAVIS PAKISTAN<br />

SINUTAB TABLET N/A PARKE-DAVIS PAKISTAN<br />

SIOPEL CREAM CREAM N/A BIOGLAN<br />

LABORATORIES LTD<br />

SIPRAZON 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS<br />

SIPROGUT GOZ DAMLASI 0.3 % OPHTHALMIC SOLUTION 0.3% BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

UNITED KINGDOM<br />

TURKEY<br />

SIPROX 100 MG TABLETS TABLETS 100 MG DELTA HF ICELAND<br />

SIPROX 500 MG TABLETS TABLET 500 MG DELTA HF ICELAND


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 705<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SIPROX 750 MG TABLET 750MG DELTA HF ICELAND<br />

SIX PLUS PARAPED SUSPENSION ORAL SUSPENSION 250MG/5ML PINEWOOD<br />

LABORATORIES LIMITED<br />

T/A PINEWOOD<br />

HEALTHCARE LIMITED<br />

SKINOREN CREAM 0.2G/G SCHERING AG ITALY<br />

SKINOREN CREAM 20G/100G SCHERING SPA ITALY<br />

SLOW K TABLETS TABLETS 600 MG NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

SLOW-FE MODIFIED RELEASE<br />

TABLETS<br />

SLOW-FE FOLIC MODIFIED RELEASE<br />

TABLETS<br />

160MG NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

N/A NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

SLOW-K TABLETS 600MG NOVARTIS PHARMA B.V.<br />

AMHEM<br />

SLOW-K TABLETS 600MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

UNITED KINGDOM<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

SWITZERLAND<br />

SMILITENE CAPSULE 100MG RAFARM GREECE<br />

SMILITENE CAPSULE 100MG RAFARM GREECE<br />

SMOODERM CREAM NA DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

JORDAN<br />

SNIP TABLETS N/A MEDOCHEMIE LTD CYPRUS<br />

SNO PHENICOL EYE DROPS 0.5%<br />

W/V<br />

SNOWFIRE HEALING TABLET<br />

OINTMENT<br />

SNUFFLEBABE VAPOUR RUB NASAL INHALATION<br />

OINTMENT<br />

SODAMINT BP/ SODIUM<br />

BICARBONATE COMP. BP<br />

SODIO CLORURO SOLUTION FOR IV<br />

INFUSION<br />

SODIO CLORURO SOLUTION FOR IV<br />

INFUSION<br />

EYE DROPS 0.5% W/V CHAUVIN<br />

PHARMACEUTICALS<br />

LIMITED<br />

UNITED KINGDOM<br />

OINTMENT N/A J PICKLES & SONS UNITED KINGDOM<br />

N/A J PICKLES & SONS UNITED KINGDOM<br />

TABLET N/A SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

0.9G/ML INDUSTRIA<br />

FARMACEUTICA<br />

GALENICA SENESE S.R.L.<br />

0.9% W/V INDUSTRIA<br />

FARMACEUTICA<br />

GALENICA SENESE S.R.L.<br />

SODIUM BICARBONATE TABLETS 600MG NORTON<br />

PHARMACEUTICALS<br />

LIMITED<br />

SODIUM BICARBONATE CAPSULES 500MG NORTON HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SODIUM BICARBONATE BP ORAL MPOWDER N/A LCM LTD UNITED KINGDOM


EN<br />

706 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SODIUM BICARBONATE INJ<br />

MINIJET<br />

SODIUM BICARBONATE INJ<br />

MINIJET<br />

SODIUM BICARBONATE IV INF.<br />

POLYFUSOR BD<br />

SODIUM BICARBONATE IV INF.<br />

POLYFUSOR BD<br />

AQUEOUS SOLUTION 4.2% W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

AQUEOUS SOLUTION 8.4%W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

LTD<br />

SOLUTION FOR<br />

INJECTIONS<br />

SOLUTION FOR<br />

INJECTIONS<br />

SODIUM BICARBONATE MINIJET SOLUTION FOR<br />

INJECTION<br />

SODIUM BICARBONATE MINJET SOLUTION FOR<br />

INJECTION<br />

SODIUM BICARBONATE TABLETS<br />

600MG<br />

SODIUM CHLORIDE + DEXTROSE<br />

(0.9+5)%<br />

SODIUM CHLORIDE + DEXTROSE<br />

(O.18 +4)%<br />

SODIUM CHLORIDE 0.225% +<br />

GLUCOSE 5%<br />

SODIUM CHLORIDE 0.45% AND<br />

GLUCOSE 5%<br />

SODIUM CHLORIDE 0.9% (5, 10<br />

OR 20ML) AMP<br />

SODIUM CHLORIDE 0.9%<br />

AGUETTANT<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

1.4% W/V FRESENIUS LIMITED UNITED KINGDOM<br />

8.4%W/V FRESENIUS LIMITED UNITED KINGDOM<br />

4.2%W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

8.4% W/V INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

TABLETS 600MG NORTON<br />

PHARMACEUTICALS<br />

LIMITED<br />

SOLUTION FOR IV<br />

INFUSION<br />

NA DEMA SA GREECE<br />

SOLUTION F/IV INFUSION NA DEMA SA GREECE<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SODIUM CHLORIDE 0.9% DEMO SOLUTION FOR<br />

INFUSION<br />

SODIUM CHLORIDE 0.9% SCHIWA SOLUTION FOR<br />

INFUSION<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

N/A BAXTER HEALTHCARE<br />

LIMITED<br />

0.9% DEMO SA GREECE<br />

INJECTABLE SOLUTION 0.9% W/V LABORATOIRE<br />

AGUETTANT<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

0.9% DEMO SA GREECE<br />

9G/1000ML B.BRAUN MELSUNGEN GERMANY<br />

SODIUM CHLORIDE 0.9% W/V SOL. FOR INJ./INF. 0.9%W/V PARACELCIA INDUSTRIA<br />

FARMACEUTICA S.A.<br />

SODIUM CHLORIDE AGUETTANT INJECTABLE SOLUTION 0.9% W/V LABORATOIRE<br />

AGUETTANT<br />

SODIUM CHLORIDE INJECTION SOLUTION FOR<br />

INJECTION<br />

SODIUM CHLORIDE INJECTION SOLUTION FOR<br />

INJECTION<br />

SODIUM CHLORIDE INJECTION<br />

B.P.<br />

SOLUTION FOR<br />

INJECTION<br />

SODIUM CHLORIDE INJECTION BP SOLUTION FOR<br />

INJECTION<br />

0.9%W/V ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

0.9%W/V ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

0.9% W/V PHOENIX<br />

PHARMACEUTICALS<br />

LIMITED<br />

PORTUGAL<br />

FRANCE<br />

IRELAND<br />

IRELAND<br />

UNITED KINGDOM<br />

0.9% W/V PHOENIX PHARMA LTD UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 707<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SODIUM CHLORIDE INJECTION BP SOLUTION FOR<br />

INJECTION<br />

SODIUM CHLORIDE INJECTION BP<br />

0.9% W/V<br />

SODIUM CHLORIDE INJECTION<br />

DEMO<br />

SODIUM CHLORIDE<br />

INJECTION/DEMO<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INFUSION<br />

SODIUM CHLORIDE IV INFUSION SOLUTION FOR<br />

INJECTION<br />

SODIUM CHLORIDE IV INFUSION SOLUTION FOR<br />

INJECTION<br />

SODIUM CLORIDE INJECTION SOLUTION FOR<br />

INJECTION<br />

0.9% ANTIGEN<br />

PHARMACEUTICALS LTD<br />

0.9% W/V MACARTHYS LABS LTD.<br />

T/A MARTINDALE<br />

PHARMACEUTICALS<br />

IRELAND<br />

0.9% DEMO SA GREECE<br />

SOLUTIO IV. INFUSION 0.9%W/V DEMO S.A. GREECE GREECE<br />

0.45%W/V BAXTER HEALTHCARE<br />

LIMITED<br />

0.9%W/V BAXTER HEALTHCARE<br />

LIMITED<br />

0.9%W/V ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

SODIUM CROMOGLYCATE 2% EYE DROPS 2%W/W DOMINION PHARMA<br />

LIMITED<br />

SODIUM IODIDE (131.I)<br />

DIAGNOSTIC CAPSULE<br />

SODIUM NITROPRUSSIDE FOR IV<br />

INF.<br />

SODIUM VALPROATE ENTERIC COATED<br />

TABLETS<br />

SODIUM VALPROATE ENTERIC COATED<br />

TABLETS<br />

CAPSULE 333KBQ-3.7MBQ NYCOMED AMERSHAM<br />

PLC<br />

POWDER FOR INJECTION 50MG/VIAL FAULDING<br />

PHARMACEUTICALS PLC<br />

200MG NORTON HEALTHCARE<br />

LIMITED<br />

500MG NORTON HEALTHCARE<br />

LIMITED<br />

SODIUM VALPROATE SUGAR FREE SOLUTION 200MG/5ML NORTON HEALTHCARE<br />

LIMITED<br />

SOFRADEX EAR EYE OINTMENT EAR/EYE OINTMENT N/A ROUSSEL<br />

LABORATORIES LIMITED<br />

SOFRADEX EAR/EYE DROPS EAR/EYE DROPS N/A ROUSSEL<br />

LABORATORIES LIMITED<br />

SOFRAMYCIN EYE DROPS EYE DROPS 0.5% W/V ROUSSEL<br />

LABORATORIES LIMITED<br />

SOFRAMYCIN EYE OINTMENT<br />

0.55% W/W<br />

OINTMENT 0.55% W/W ROUSSEL<br />

LABORATORIES LIMITED<br />

SOFRAMYCIN SKIN OINTMENT OINTMENT N/A ROUSSEL<br />

LABORATORIES LIMITED<br />

SOFRA-TULLE PAD (DRESSING) 1.05% W/W ROUSSEL<br />

LABORATORIES LIMITED<br />

SOFT CORN REMOVAL PADS PLASTER 12%W/W SCHOLL CONSUMER<br />

PRODUCTS<br />

SOLAQUIN CREAM 2% ICN PHARMACEUTICALS<br />

INC.<br />

SOLAQUIN FORTE CREAM 4% ICN PHARMACEUTICALS<br />

INC.<br />

SOLAQUIN FORTE GEL 4% ICN PHARMACEUTICALS<br />

INC.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA


EN<br />

708 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SOLAQUIN FORTE 4% GEL N/A ICN PHARMACEUTICALS,<br />

INC.<br />

SOLAQUIN FORTE 4% CREAM N/A ICN PHARMACEUTICALS<br />

INC.<br />

SOLARCAINE CREAM N/A SCHERING-PLOUGH<br />

LIMITED<br />

SOLARCAINE GEL GEL 0.5% W/W SCHERING-PLOUGH<br />

LIMITED<br />

SOLARCAINE LOTION TOPICAL EMULSION N/A SCHERING-PLOUGH<br />

LIMITED<br />

SOLARCAINE TOPICAL AEROSOL<br />

LIQUID SPRAY<br />

SOLCODERM SOLUTION SOL. FOR EXTERNAL<br />

APPL.<br />

SOLCOGYN SOLUTION SOLUTION FOR CERVIX<br />

UTERI<br />

SOLCOSERYL SOLUTION FOR IV<br />

INJECTION<br />

TOPICAL SPRAY N/A SCHERING-PLOUGH<br />

LIMITED<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

N/A SOLCO BASLE LTD. SWITZERLAND<br />

N/A SOLCO BASLE LTD. SWITZERLAND<br />

42.5MG/ML SOLCO BASLE LTD. SWITZERLAND<br />

SOLCOSERYL OINTMENT 2.07MG/G SOLCO BASLE LTD. SWITZERLAND<br />

SOLCOSERYL DENTAL ADHESIVE<br />

PASTE<br />

ORAL AND GINGIVAL<br />

PASTE<br />

2.125MG/G SOLCO BASLE LTD. SWITZERLAND<br />

SOLCOSERYL JELLY GEL 4.15MG/G SOLCO BASLE LTD. SWITZERLAND<br />

SOLCOTRICHOVAC POWDER FOR INJECTION 7×10(9) SOLCO BASLE LTD. SWITZERLAND<br />

SOLEZE ANTISEPTIC CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM<br />

SOLIAN 100MG SCORED TABLET 100MG SANOFI SYNTHELABO FRANCE<br />

SOLIAN 400MG SCORED FILM-COATED<br />

TABLET<br />

400MG SANOFI SYNTHELABO FRANCE<br />

SOLOFALK SUPPOSITORIES 500MG DR.FALK PHARMA GMBH GERMANY<br />

SOLONEX T-150 TABLET N/A MACLEODS<br />

PHARMACEUTICALS LTD<br />

SOLONEX T-75 TABLET N/A MACLEODS INDIA<br />

SOLONEX-100 TABLETS 100MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

SOLONEX-300 TABLET 300MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

SOLPADEINE CAPSULES CAPSULE N/A SMITHKLINE BEECHAM<br />

(SWG) LTD T/A SMITHK.<br />

BEECH. CONS. HLTHC.<br />

SOLPADEINE SOLUBLE TABLETS TABLET FOR ORAL<br />

SOLUTION<br />

N/A SMITHKLINE BEECHAM<br />

(SWG) LIMITED<br />

SOLPADEINE TABLETS TABLET N/A SMITHKLINE BEECHAM<br />

(SWG) LTD T/A STERLING<br />

HEALTH/SKB INTRNTL<br />

SOLPAFLEX TABLETS COATED TABLET N/A SMITHKLINE BEECHAM<br />

INTERNATIONAL<br />

SOLPRENE OPHTHALMIC DROPS N/A FARMIGEA SPA ITALY<br />

INDIA<br />

INDIA<br />

INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 709<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SOLU CORTEF POWDER FOR SOL FOR<br />

INJ<br />

SOLUDAMIN SINGLE DOSE ORAL<br />

SOLUTION<br />

SOLU-MEDROL SOLUTION FOR<br />

INJECTION<br />

SOLU-MEDROL SOLUTION FOR<br />

INJECTION<br />

SOLU-MEDROL SOLUTION FOR<br />

INJECTION<br />

SOLUTION INJ. DE CITRATE DE<br />

GALLIUM 67<br />

SOLUTION FOR<br />

INJECTION<br />

100MG/VIAL PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

BELGIUM<br />

1G/SINGLE DOSE KLEVA LIMITED GREECE<br />

500MG/VIAL PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

40MG/ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

125MG/2ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

BELGIUM<br />

BELGIUM<br />

BELGIUM<br />

74 MBQ/ML CIS BIO INTERNATIONAL FRANCE<br />

SOLUWAX EAR DROPS 0.5% W/V HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

SOLUZIONI PER DIALISI<br />

PERITONEALE (FUN)<br />

SOLN FOR PERITON.<br />

DIALYS.<br />

MALAYSIA<br />

N/A BIEFFE MEDITAL S.P.A. ITALY<br />

SOLVIN(BROMHEXINE ELIXIR) ELIXIR 4MG/5ML IPCA LABORATORIES<br />

LIMITED<br />

SOMATOSTATINE UCB POWDER FOR INJECTION 3MG/ML U.C.B. S.A. BELGIUM<br />

SOMATOSTATINE UCB LYOPHILISED FOR<br />

INJECTION<br />

250MCG UCB SA — SECTEUR<br />

PHARMA<br />

INDIA<br />

BELGIUM<br />

SOMATOSTATIN-UCB POWDER FOR INJECTION 250MCG UCB SA BELGIUM<br />

SOMAZINA DROPS 10G/100ML FERRER<br />

INTERNACIONAL, S.A.<br />

SOMNITE SUSPENSION 2.5MG/5ML NORGINE LIMITED UNITED KINGDOM<br />

SOMNUS COATED TABLET N/A CATHAY OF<br />

BOURNEMOUTH LTD<br />

SONA B COMPLEX TABLETS N/A SONA NUTRITION LTD. IRELAND<br />

SONA MULTIPLUS TABLETS N/A SONA NUTRITION LTD. IRELAND<br />

SPAIN<br />

UNITED KINGDOM<br />

SONATA HARD CAPSULES 5MG WYETH EUROPA LTD. UNITED KINGDOM<br />

SONATA HARD CAPSULE 10MG WYETH EUROPA LTD. UNITED KINGDOM<br />

SOOTHAKE GEL DENTAL GEL N/A J PICKLES & SONS UNITED KINGDOM<br />

SOOTHAKE TOOTHACHE<br />

TINCTURE<br />

DENTAL SOLUTION N/A J PICKLES & SONS UNITED KINGDOM<br />

SOOV BITE GEL N/A EGO PHARMACEUTICALS AUSTRALIA<br />

SOOV BURN SPRAY AEROSOL N/A EGO PHARMACEUTICALS AUSTRALIA<br />

SOOV CREAM CREAM N/A EGO PHARMACEUTICALS AUSTRALIA<br />

SOTALOL TABLETS 80MG TABLETS 80MG MCDERMOTT<br />

LABORATORIES LTD T/A<br />

GERARD LABORATORIES<br />

IRELAND<br />

SOTILEN CAPSULES 20MG MEDOCHEMIE LTD CYPRUS<br />

SOTILEN 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS


EN<br />

710 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SPASMOMEN COATED TABLET 40MG A.MENARINI INDUSTRIE<br />

FARMACEUTICHE<br />

RIUNITE S.R.L.<br />

SPASMONAL CAPSULES 60MG NORGINE LIMITED UNITED KINGDOM<br />

SPASMONAL CAPSULES CAPSULES 60 MG NORGINE LIMITED UNITED KINGDOM<br />

SPASMOPRIV CAPSULE 100MG POLIPHARM CO. LTD. THAILAND<br />

SPECTRABAN ULTRA 28<br />

(SOLABAN A + B)<br />

LOTION N/A STIEFEL LABORATORIES<br />

(UK) LTD<br />

ITALY<br />

IRELAND<br />

SPERSACARPINE 1% EYE DROPS 1% W/V CIBA VISION AG SWITZERLAND<br />

SPERSACARPINE 2% EYE DROPS 2% W/V CIBA VISION AG SWITZERLAND<br />

SPERSACARPINE 2% EYE DROPS NA NOVARTIS<br />

OPHTHALMICS AG<br />

SWITZERLAND<br />

SPERSADEX 0.1% EYE DROPS 1MG/ML CIBA VISION AG SWITZERLAND<br />

SPERSADEX 0.1% EYE DROPS 1.00MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

SPERSADEX COMP EYE DROPS NA NOVARTIS<br />

OPHTHALMICS AG<br />

SWITZERLAND<br />

SWITZERLAND<br />

SPERSADEX COMP. EYE DROPS N/A CIBA VISION AG SWITZERLAND<br />

SPERSALLERG EYE DROPS N/A CIBA VISION AG SWITZERLAND<br />

SPERSALLERG EYE DROPS NA NOVARTIS<br />

OPHTHALMICS AG<br />

SWITZERLAND<br />

SPERSALLERG SDU EYE DROPS N/A CIBA VISION AG SWITZERLAND<br />

SPERSALLERG SDU EYE DROPS NA NOVARTIS<br />

OPHTHALMICS AG<br />

SWITZERLAND<br />

SPERSANICOL EYE DROPS 5MG/ML CIBA VISION AG SWITZERLAND<br />

SPERSANICOL EYE OINTMENT 10MG/G CIBA VISION AG SWITZERLAND<br />

SPERSANICOL EYE DROPS 5.00MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

SPERSANICOL EYE OINTMENT 10.00MG/G NOVARTIS<br />

OPHTHALMICS AG<br />

SPIRACTIN 25 TABLETS 25MG ALPHAPHARM PTY<br />

LIMITED<br />

SPIRIVA INHALATION POWDER,<br />

CAPS.<br />

18MCG BOEHRINGER INGELHEIM<br />

PHARMA<br />

SWITZERLAND<br />

SWITZERLAND<br />

AUSTRALIA<br />

GERMANY<br />

SPORANOX 100MG CAPSULE 100MG JANSSEN-CILAG N.V. BELGIUM<br />

SPORANOX ORAL SOLUTION ORAL SOLUTION 10MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

SQUA-MED SHAMPOO N/A PERMAMED AG SWITZERLAND<br />

ST JAMES' BALM OINTMENT N/A MEDICO-BIOLOGICAL<br />

LABS LTD<br />

STABILISED CERETEC POWDER FOR INJECTION 0.5MG/VIAL NYCOMED AMERSHAM<br />

PLC<br />

STABLON 12.5MG COATED TABLET 12.5MG LES LABORATOIRES<br />

SERVIER<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 711<br />

Trade Name Dosage Form Dose MA Holder Country<br />

STADELANT TABLETS 20MG CHRISPA ALFA<br />

FARMAKEYTICI S.A.<br />

STAMARIL SOLUTION FOR SC OR IM<br />

USE<br />

GREECE<br />

1000LD50/0.5ML PASTEUR MERIEUX FRANCE<br />

STAPHYLEX CAPSULES 250MG ALPHAPHARM PTY<br />

LIMITED<br />

AUSTRALIA<br />

STAPHYLEX CAPSULES 500MG ALPHAPHARM PTY LTD AUSTRALIA<br />

STAPHYLEX 250 CAPSULE 250MG ALPHAPHARM PTY<br />

LIMITED<br />

STAPHYLEX 500 CAPSULE 500MG ALPHAPHARM PTY<br />

LIMITED<br />

AUSTRALIA<br />

AUSTRALIA<br />

STAPHYLEXIN 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS<br />

STARIL TABLETS 10MG BRISTOL-MYERS SQUIBB<br />

S.P.A<br />

STARIL TABLETS 20MG BRISTOL-MYERS SQUIBB<br />

S.P.A<br />

STARLIX FILM-COATED TABLETS 60MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

STARLIX FILM-COATED TABLETS 120MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

STARLIX FILM COATED TABLETS 60MG NOVARTIS EUROPHARM<br />

LIMITED<br />

STARLIX FILM-COATED TABLETS 120MG NOVARTIS EUROPHARM<br />

LIMITED<br />

STARLIX FILM COATED TABLETS 180MG NOVARTIS EUROPHARM<br />

LIMITED<br />

STARLIX FILM COATED TABLETS 60MG NOVARTIS EUROPHARM<br />

LIMITED<br />

STARLIX FILM COATED TABLETS 120MG NOVARTIS EUROPHARM<br />

LIMITED<br />

STARLIX FILM COATED TABLETS 180MG NOVARTIS EUROPHARM<br />

LIMITED<br />

STAS HUSTENLOSER SAFT SOLUTION 15MG/5ML STADA OTC<br />

ARZNEIMITTEL GMBH<br />

STATICUM TABLET 5MG J.URIACH & CIA. S.A. SPAIN<br />

STAVIN-30 CAPSULE 30MG OKASA PHARMA<br />

PVT.LTD-INDIA<br />

STAVIN-40 CAPSULE 40MG OKAS PHARMA PVT- LTD<br />

-INDIA<br />

STAVIR-40 CAPSULES 40MG CIPLA LTD INDIA<br />

ITALY<br />

ITALY<br />

SWITZERLAND<br />

SWITZERLAND<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

GERMANY<br />

STEDON INJECTABLE SOLUTION 10MG/2ML ADELCO S.A. GREECE<br />

STEDON TABLET 2MG ADELCO SA GREECE<br />

STEDON TABLET 5MG ADELCO SA GREECE<br />

INDIA


EN<br />

712 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

STEDON INJ. SOLUTION 10MG/2ML ADELCO —<br />

CHROMATOURGIA<br />

ATHINON E.<br />

COLOCOTRONIS BROS<br />

S.A.<br />

STELABID TABLET N/A SMITH KLINE &<br />

BEECHAM<br />

GREECE<br />

PAKISTAN<br />

STELABID TABLETS TABLETS NA SMITHKLINE BEECHAM PAKISTAN<br />

STELAZINE TABLET 1MG SMITH KLINE &<br />

BEECHAM<br />

PAKISTAN<br />

STELAZINE TABLETS 1MG SMITHKLINE & BEECHAM PAKISTAN<br />

STELAZINE SPANSULE CAPSULE<br />

2MG<br />

STELAZINE SPANSULE CAPSULES<br />

10MG<br />

STELAZINE SPANSULE CAPSULES<br />

15MG<br />

STELAZINE SPANSULE CAPSULES<br />

15MG<br />

STELAZINE SPANSULE CAPSULES<br />

2MG<br />

MODIFIED RELEASE<br />

CAPSULE<br />

MODIFIED RELEASE<br />

CAPSULE<br />

MODIFIED RELEASE<br />

CAPSULE<br />

MODIFIED RELEASE<br />

CAPSULE<br />

MODIFIED RELEASE<br />

CAPSULE<br />

2MG GOLDSHIELD<br />

PHARMACEUTICALS LTD<br />

10MG GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED T/A<br />

GOLDSHIELD<br />

15MG GOLDSHIELD<br />

PHARMACEUTICALS LTD<br />

15MG GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED T/A<br />

GOLDSHIELD<br />

2MG GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED T/A<br />

GOLDSHIELD<br />

STELAZINE SYRUP SYRUP 1MG/5ML GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED T/A<br />

GOLDSHIELD<br />

STELAZINE TABLETS 1MG COATED TABLET 1MG GOLDSHIELD<br />

PHARMACEUTICALS LTD<br />

STELAZINE TABLETS 1MG COATED TABLET 1MG GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED T/A<br />

GOLDSHIELD<br />

STELAZINE TABLETS 5MG COATED TABLET 5MG GOLDSHIELD<br />

PHARMACEUTICALS LTD<br />

STELAZINE TABLETS 5MG COATED TABLET 5MG GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED T/A<br />

GOLDSHIELD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

STEMETIL TABLET 5MG RHONE POULENC PAKISTAN<br />

STEMETIL TABLET 5MG RHONE-POULENC-RORER PAKISTAN<br />

STEMETIL INJECTION 1.25% W/V SOLUTION FOR<br />

INJECTION<br />

STEMETIL INJECTION 1.25%W/V SOLUTION FOR<br />

INJECTION<br />

1.25% W/V CASTLEMEAD<br />

HEALTHCARE LIMITED<br />

1.25%W/V CASTLEMEAD<br />

HEALTHCARE LTD<br />

STEMETIL TABLES 25MG TABLET 25MG CASTLEMEAD<br />

HEALTHCARE LIMITED<br />

UNITED KINGDOM<br />

IRELAND<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 713<br />

Trade Name Dosage Form Dose MA Holder Country<br />

STEMETIL TABLETS TABLETS 5MG CASTLEMEAD<br />

HEALTHCARE LTD<br />

STEMETIL TABLETS TABLET 25MG CASTLEMEAD<br />

HEALTHCARE LTD<br />

STEMETIL TABLETS 5MG TABLET 5MG CASTLEMEAD<br />

HEALTHCARE LIMITED<br />

STERETS NORMASOL TOPICAL SOLUTION 0.9% W/V SETON PREBBLES<br />

LIMITED<br />

STERETS UNISEPT TOPICAL SOLUTION 0.25% V/V SETON PREBBLES<br />

LIMITED<br />

STERIFLEX N0.5 SODIUM<br />

CHLORIDE 0.18%<br />

STERIFLEX NO 10 DARR0W'S<br />

SOLUTION<br />

STERIFLEX NO 11 HARTMANNS<br />

SOLUTION<br />

STERIFLEX NO 31 DEXTROSE IV<br />

INFUSION 20%<br />

STERIFLEX NO 34 DEXTROSE IV<br />

INFUSION BP<br />

SOLUTION FOR IV<br />

INFUSION<br />

IRELAND<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

0.18% W/V FRESENIUS LIMITED UNITED KINGDOM<br />

SOUTION FOR INJECTION N/A FRESENIUS LIMITED UNITED KINGDOM<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR IV<br />

INFUSION<br />

SOLUTION FOR IV<br />

INFUSION<br />

STERIFLEX NO 42 SOLUTION FOR<br />

INJECTIONS<br />

STERIFLEX NO 45 SODIUM<br />

CHLORIDE AND DEXT.<br />

STERIFLEX NO 6 DEXTROSE IV<br />

INF. 5%<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR IV<br />

INFUSION<br />

STERIFLEX NO 7 DEXTROSE 10% SOLUTION FOR IV<br />

INFUSION<br />

STERIFLEX NO 9 RINGERS<br />

SOLUTION<br />

STERIFLEX NO.2 SODIUM<br />

CHLORIDE 0.45%<br />

STERIFLEX NO1 SODIUM<br />

CHLORIDE 0.9%<br />

STERIFLEX NO3 SODIUM<br />

CHLORIDE AND DEXTROSE<br />

STERILE CARDIOPLEGIA<br />

CONCENTRATE<br />

STERILE DOBUTAMINE HCL<br />

CONCENTRATE<br />

STERILE DOBUTAMINE<br />

HYDROCHLORIDE<br />

STERILE DOBUTAMINE<br />

HYDROCHLORIDE CONC.<br />

SOLUTION FOR<br />

INJECTIONS<br />

SOLUTION FOR IV<br />

INFUSION<br />

SOLUTION FOR IV<br />

INFUSION<br />

SOLUTION FOR IV<br />

INFUSION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

N/A FRESENIUS LIMITED UNITED KINGDOM<br />

20% W/V FRESENIUS LIMITED UNITED KINGDOM<br />

50% W/V FRESENIUS LIMITED UNITED KINGDOM<br />

N/A FRESENIUS LIMITED UNITED KINGDOM<br />

N/A FRESENIUS LIMITED UNITED KINGDOM<br />

5% W/V FRESENIUS LIMITED UNITED KINGDOM<br />

10%W/V FRESENIUS LIMITED UNITED KINGDOM<br />

N/A FRESENIUS LIMITED UNITED KINGDOM<br />

0.45% W/V FRESENIUS LIMITED UNITED KINGDOM<br />

0.9% W/V FRESENIUS LIMITED UNITED KINGDOM<br />

N/A FRESENIUS LIMITED UNITED KINGDOM<br />

N/A F.H. FAULDING & CO.<br />

LTD (T/A DAVID BULL<br />

LABS)<br />

250MG/20ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

250MG/IN 20ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

250MG/20ML ANTIGEN<br />

PHARMACEUTICALS<br />

LIMITED<br />

AUSTRALIA<br />

IRELAND<br />

IRELAND<br />

IRELAND


EN<br />

714 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

STERILE DOPAMINE CONC.<br />

SELECTAJET<br />

STERILE DOPAMINE<br />

CONCENTRATE 200MG/5ML<br />

STERILE DOPAMINE HCL<br />

INJECTION AMPOULE<br />

STERILE SODIUM CHLORIDE<br />

CONC. BP 30%W/V<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

CONCENTRATE FOR<br />

INJECTION<br />

STERILE WATER FOR INJECTION SOLUTION FOR<br />

INJECTION<br />

STERILE WATER FOR INJECTION<br />

USP<br />

STERILE WATER FOR IRRIGATION<br />

USP<br />

STERWIN REAL LEMON COLD<br />

POWDERS<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

IRRIGATION<br />

POWDER FOR ORAL<br />

SOLUTION<br />

40MG/ML INTERNATIONAL<br />

MEDICATION SYSTEMS<br />

(UK) LIMITED<br />

200MG/5ML FAULDING<br />

PHARMACEUTICALS PLC<br />

200MG/5ML F.H. FAULDING & CO LTD<br />

(T/A DAVID BULL LABS)<br />

30%W/V MACARTHYS LABS.<br />

LIMITED T/A<br />

MARTINDALE<br />

PHARMACEUTICALS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

UNITED KINGDOM<br />

NO ACTIVE ING. ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

NA ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

NO ACTIVE ING. ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

N/A SANOFI WINTHROP<br />

LIMITED<br />

STIEMYCIN 2% W/W TOPICAL SOLUTION 2% W/W STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

STIEVA-A CREAM 0.05% CREAM 0.05% THERAPEX INC. CANADA<br />

STIEVA-A FORTE CREAM 0.1% CREAM 0.1% THERAPEX INC CANADA<br />

STIEVAMYCIN GEL JELLY N/A STIEFEL CANADA INC CANADA<br />

STILNOX 10MG FILM-COATED TABLET 10MG LABORATOIRES<br />

SYNTHELABO<br />

STIMOL ORAL SOLUTION IN<br />

SACHETS<br />

2G LABORATOIRES<br />

BIOCODEX<br />

STIMOL ORAL SOLUTION 1G/10ML LABORATOIRES<br />

BIOCODEX<br />

STINGOSE PUMP SPRAY<br />

DISPENSER<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

TOPICAL SOLUTION 20% W/V WELLVALUE LTD UNITED KINGDOM<br />

STOCRIN ORAL SOLUTION 30MG/ML MERCK SHARP & DOHME<br />

LIMITED<br />

STOCRIN 100MG HARD CAPSULES 100MG MERCK SHARP & DOHME<br />

LTD.<br />

STOCRIN 200MG HARD CAPSULES 200MG MERCK SHARP & DOHME<br />

LTD.(UK)<br />

STOCRIN 50MG HARD CAPSULES 50MG MERCK SHARP & DOHME<br />

LTD. (UK)<br />

STREFEN LOZENGE NA CROOKES HEALTHCARE<br />

LIMITED<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

UNITED KINGDOM<br />

STREPSILS LOZENGE N/A KNOLL PAKISTAN<br />

STREPSILS COUGH LOZENGES LOZENGE 2.5MG CROOKES HEALTHCARE<br />

LIMITED<br />

STREPSILS HONEY AND LEMON LOZENGE N/A CROOKES HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 715<br />

Trade Name Dosage Form Dose MA Holder Country<br />

STREPSILS MENTHOL AND<br />

EUCALYPTUS<br />

LOZENGE N/A CROOKES HEALTHCARE<br />

LIMITED<br />

STREPSILS ORIGINAL LOZENGE N/A CROOKES HEALTHCARE<br />

LIMITED<br />

STREPSILS PAIN RELIEF PLUS LOZENGE N/A CROOKES HEALTHCARE<br />

LIMITED<br />

STREPSILS PAIN RELIEF SPRAY OROMUCOSAL SPRAY 2% W/V CROOKES HEALTHCARE<br />

LIMITED<br />

STREPSILS SUGAR FREE<br />

LOZENGES<br />

STREPSILS WITH HONEY AND<br />

LEMON<br />

LOZENGE N/A CROOKES HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

LOZENGE N/A KNOLL PAKISTAN<br />

STREPSILS WITH VITAMIN C LOZENGE N/A KNOLL PAKISTAN<br />

STREPSILS WITH VITAMIN C<br />

100MG<br />

STREPTASE 1,500,000 DRY SUBSTANCE FOR<br />

INJECT.<br />

STREPTASE 250 000 UI POWDER FOR<br />

INCECTABLE SOL<br />

STREPTASE 250,000 DRY SUBSTANCE FOR<br />

INJECT.<br />

STREPTASE 750,000 DRY SUBSTANCE FOR<br />

INJECT.<br />

STREPTOMYCIN SULPHATE<br />

INJECTION BP<br />

LOZENGE N/A CROOKES HEALTHCARE<br />

LIMITED<br />

POWDER FOR<br />

RECONSTITUTION<br />

15 — 18MG HOECHST MARION<br />

ROUSSEL DEUTSCHLAND<br />

GMBH<br />

250 000IU LABORATOIRES<br />

HOECHST-HOUDE<br />

2.5 — 3MG HOECHST MARION<br />

ROUSSEL DEUTSCHLAND<br />

GMBH<br />

7.5 — 9MG HOECHST MARION<br />

ROUSSEL DEUTSCHLAND<br />

GMBH<br />

UNITED KINGDOM<br />

GERMANY<br />

FRANCE<br />

GERMANY<br />

GERMANY<br />

1G/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM<br />

STRESAM CAPSULES 0.05G BIOCODEX<br />

LABORATORIES<br />

STRONG 15%W/V POTASSIUM<br />

CHLORIDE SOL.73<br />

STRONG CO-DANTHRAMER<br />

SUSPENSION<br />

INFUSION SOLUTION<br />

CONCENT<br />

STRPTASE 750 000 UI POWDER FOR<br />

INJECTABLE SOL<br />

STUD 100 DESENSITIZING SPRAY<br />

FOR MEN<br />

15% W/V B.BRAUN MELSUNGEN<br />

AG<br />

SUSPENSION N/A NAPP LABORATORIES<br />

LIMITED<br />

CUTANEOUS<br />

SPRAY,SOLUTION<br />

750 000IU LABORATOIRES<br />

HOECHST-HOUDE<br />

9.6% W/W POUND INTERNATIONAL<br />

LTD<br />

FRANCE<br />

GERMANY<br />

UNITED KINGDOM<br />

FRANCE<br />

UNITED KINGDOM<br />

STUGERON TABLET 25MG JANSSEN PAKISTAN<br />

STUGERON 25MG TABLET 25MG JANSSEN-CILAG N.V. BELGIUM<br />

STUGERON FORTE CAPSULE 75MG JANSSEN-CILAG N.V. BELGIUM<br />

SUBCUTANEOUS CALCIPARINE SOLUTION FOR<br />

SUBCUTANEOUS<br />

INJECTION<br />

SUBUTEX 2MG SUBLINGUAL<br />

TABLETS<br />

SUBUTEX 8MG SUBLINGUAL<br />

TABLETS<br />

5000IU/0.2ML SANOFI-SYNTHELABO FRANCE<br />

SUBLINGUAL TABLET 2MG SCHERING-PLOUGH<br />

LIMITED<br />

SUBLINGUAL TABLET 8MG SCHERING-PLOUGH<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

716 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SUCRALAN TABLET 1G LANNACHER HEIMITTEL<br />

GMBH<br />

SUCRALFATE TABLETS 1G TABLETS 1G NORTON HEALTHCARE<br />

LIMITED<br />

SUCRANASE TABLETS 255MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

SUDAFED ELIXIR SYRUP 30MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

SUDAFED TABLETS 60MG FILM COATED TABLETS 60MG GLAXO WELLCOME UK<br />

LIMITED<br />

SUDOCREM ANTISEPTIC HEALING<br />

CREAM<br />

CREAM N/A TOSARA PRODUCTS (UK)<br />

LTD<br />

AUSTRIA<br />

UNITED KINGDOM<br />

JORDAN<br />

SUFENTA 2ML AMPOULES INJECTABLE SOLUTION 0.01MG/2ML JANSSEN-CILAG N.V. BELGIUM<br />

SULFADIAZIN-HEYL TABLETS 500MG HEYL CHEMISCH-<br />

PHARMAZEUTISCHE<br />

FABRIK GMBH & CO. KG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

SULFADOXINE + PYRIMETHAMINE TABLETS 500MG + 25MG PHARMAMED LTD. MALTA<br />

SULFASALAZINE-HEYL GASTRO-RESISTANT F/C<br />

TAB<br />

500MG HEYL CHEMISCH-<br />

PHARMAZEUTISCHE<br />

FABRIK GMBH & CO KG<br />

SULPHADIAZINE TABLETS BP TABLET 500MG CP PHARMACEUTICALS<br />

LTD<br />

SULPHADIAZINE TABLETS BP<br />

500MG<br />

TABLETS 500MG CP PHARMACEUTICALS<br />

LTD.<br />

SULPHADIMIDINE BP 500MG TABLET 500MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SULPHAKREAM-N CREAM N/A NABIQASIM PAKISTAN<br />

SULPIREN 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS<br />

SULPIRIDE TABLETS 200MG NORTON HEALTHCARE<br />

LIMITED<br />

SULTRIN VAGINAL CREAM N/A JANSSEN-CILAG N.V. BELGIUM<br />

UNITED KINGDOM<br />

SUPER WATE ON EMULSION ORAL EMULSION N/A D D D LIMITED UNITED KINGDOM<br />

SUPPOSTE GLICER.S.PELLEGRINO SUPPOSITORY 2.72G SYNTHELABO S.P.A. ITALY<br />

SUPPOSTE GLICER.S.PELLEGRINO SUPPOSITORY 1.36G SYNTHELABO S.P.A. ITALY<br />

SUPRA-VIR CREAM 5%W/W TRIMA ISRAEL<br />

PHARMACEUTICAL<br />

PRODUCTS LTD<br />

ISRAEL<br />

SUPRAVIRAN 200 TABLET 206.185MG GRUNENTHAL GMBH GERMANY<br />

SUPRAVIRAN 250 POWDER FOR I.V.<br />

INFUSION<br />

N/A GRUNENTHAL GMBH GERMANY<br />

SUPRAVIRAN 400 TABLET 412.37MG GRUNENTHAL GMBH GERMANY<br />

SUPRAVIRAN 800 TABLETS 824.74MG GRUNENTHAL GMBH GERMANY<br />

SUPRAVIRAN CREAM CREAM N/A GRUNENTHAL GMBH GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 717<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SUPREFACT 100MCG (1MG/ML) NASAL SOLUTION 1MG/ML LABORATOIRES AVENTIS FRANCE<br />

SURAFEM PULVULES 20MG ELI LILLY AND COMPANY UNITED STATES OF<br />

AMERICA<br />

SURELAX HERBAL TABLET N/A GERARD HOUSE LIMITED<br />

T/A ENGLISH GRAINS<br />

HEALTHCARE<br />

SURGAM 200MG TABLET 200MG LABORATOIRES AVENTIS FRANCE<br />

SURGAM 300MG SUPPOSITORY 300MG LABORATOIRES<br />

ROUSSEL<br />

SURGAM SA CAPSULES 300MG MODIFIED RELEASE<br />

CAPSULE<br />

300MG ROUSSEL<br />

LABORATORIES LIMITED<br />

SURGAM TABLETS 300MG TABLET 300MG ROUSSEL<br />

LABORATORIES LIMITED<br />

SURGICAL SPIRIT BP TOPICAL SOLUTION 95% V/V WILLIAM RANSOM &<br />

SON PLC<br />

UNITED KINGDOM<br />

FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SURGICAL SPIRIT BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM<br />

SURGICAL SPIRIT BP TOPICAL SOLUTION NA LCM LIMITED UNITED KINGDOM<br />

SURMONTIL COATED TABLET 10MG FUTUNA LIMITED UNITED KINGDOM<br />

SURMONTIL COATED TABLETS 25MG FUTUNA LIMITED UNITED KINGDOM<br />

SURMONTIL CAPSULES 50MG FUTUNA LIMITED UNITED KINGDOM<br />

SURMONTIL 10MG TABLETS COATED TABLET 10MG FUTUNA LIMITED UNITED KINGDOM<br />

SURMONTIL CAPSULES 50MG CAPSULE 50MG FUTUNA LIMITED UNITED KINGDOM<br />

SURMONTIL TABLETS 25MG COATED TABLET 25MG FUTUNA LIMITED UNITED KINGDOM<br />

SURVANTA SUSP.ENDOTRACHEOPLM.<br />

INSTI<br />

SURVANTA (BERACTANT) INTRATRACHEAL<br />

SUSPENSION<br />

25MG/ML ABBOTT LABORATORIES<br />

LIMITED<br />

UNITED KINGDOM<br />

25MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

SURVIVE 10MG TABLETS 10MG WERRICK PAKISTAN<br />

SUSSEX PHARMACEUTICAL COLD<br />

RELIEF CAPS.<br />

SUSSEX PHARMACEUTICAL HOT<br />

LEMON<br />

CAPSULE N/A SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

POWDER N/A SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SUSTAC TABLETS 2.6MG PHARMAX LIMITED UNITED KINGDOM<br />

SUSTAC MODIFIED RELEASE<br />

TABLETS<br />

6.4MG PHARMAX LIMITED UNITED KINGDOM<br />

SUSTAC SLOW RELEASE TABLETS 2.6MG PHARMAX LIMITED UNITED KINGDOM<br />

SUSTANON SOLUTION FOR<br />

INJECTION<br />

SUSTANON 100 INJECTION SOLUTION FOR<br />

INJECTION<br />

SEE INGREDIENTS ORGANON<br />

LABORATORIES LTD.<br />

N/A ORGANON<br />

LABORATORIES LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

718 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SUSTANON 250 INJECTION SOLUTION FOR<br />

INJECTION<br />

N/A ORGANON<br />

LABORATORIES LIMITED<br />

UNITED KINGDOM<br />

SWARM CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM<br />

SYMBICORT MITE TURBUHALER INHALATION POWDER N/A DRACO LAKEMEDEL AB SWEDEN<br />

SYMBICORT TURBUHALER INHALATION POWDER N/A DRACO LAKEMEDEL AB SWEDEN<br />

SYNACTHEN DEPOT AQUEOUS INJECTABLE<br />

SUSP.<br />

SYNAGIS POWDER AND SOLVENT<br />

F/SOLUTION F/INJECTION<br />

SYNAGIS POWDER AND SOLVENT<br />

F/SOLUTION F/INJECTION<br />

1MG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

50MG ABBOTT LABORATORIES<br />

LIMITED<br />

100MG ABBOTT LABORATORIES<br />

LIMITED<br />

SWITZERLAND<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

SYNALAR GEL 0.025% W/W ZENECA LIMITED UNITED KINGDOM<br />

SYNALAR CREAM 0.025% W/W ZENECA LIMITED UNITED KINGDOM<br />

SYNALAR OINTMENT 0.025% W/W ZENECA LIMITED UNITED KINGDOM<br />

SYNALAR 1 IN 4 CREAM 0.00625%W/W ZENECA LIMITED UNITED KINGDOM<br />

SYNALAR C CREAM CREAM N/A BIOGLAN<br />

LABORATORIES LTD<br />

SYNALAR C OINTMENT OINTMENT N/A BIOGLAN<br />

LABORATORIES LTD<br />

SYNALAR CREAM CREAM 0.025% W/W BIOGLAN<br />

LABORATORIES LTD<br />

SYNALAR CREAM 1/10 DILUTION CREAM 0.0025% W / W BIOGLAN<br />

LABORATORIES LTD<br />

SYNALAR CREAM 1/4 DILUTION CREAM 0.006% W / W BIOGLAN<br />

LABORATORIES LTD<br />

SYNALAR GEL GEL 0.025% W / W BIOGLAN<br />

LABORATORIES LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SYNALAR N CREAM N/A ZENECA LIMITED UNITED KINGDOM<br />

SYNALAR N OINTMENT N/A ZENECA LIMITED UNITED KINGDOM<br />

SYNALAR N CREAM CREAM N/A BIOGLAN<br />

LABORATORIES LTD<br />

SYNALAR N OINTMENT OINTMENT N/A BIOGLAN<br />

LABORATORIES LTD<br />

SYNALAR OINTMENT 0.025%<br />

W/W<br />

SYNALAR OINTMENT 1/4<br />

DILUTION<br />

OINTMENT 0.025% W / W BIOGLAN<br />

LABORATORIES LTD<br />

OINTMENT 0.006% W/W BIOGLAN<br />

LABORATORIES LTD<br />

SYNALGO TABLETS 680MG GEYMONAT SPA ITALY<br />

SYNAREL NASAL SPRAY 2MG/ML MONSANTO PLC T/A<br />

SEARLE<br />

SYNAREL NASAL SPRAY 0.2%W/V MONSANTO PLC T/A<br />

SEARLE<br />

SYNCLAR-250 TABLET 250MG CIPLA LIMITED INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SYNDOL TABLET N/A MARION MERRELL LTD UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 719<br />

Trade Name Dosage Form Dose MA Holder Country<br />

SYNDOL CAPLETS TABLET NA SETON PRODUCTS<br />

LIMITED<br />

SYNPHASE TABLET N/A MONSANTO PLC T/A<br />

SEARLE<br />

SYNTOCINON SOLUTION FOR<br />

INJECTION<br />

SYNTOCINON SOLUTION FOR<br />

INJECTION<br />

SYNTOMETRINE SOLUTION FOR<br />

INJECTION<br />

SYNTOMETRINE SOLUTION FOR<br />

INJECTION<br />

10IU/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

10IU NOVARTIS<br />

FARMACEUTICA S.A<br />

N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

NA NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SPAIN<br />

SWITZERLAND<br />

IRELAND<br />

SYNTOMYCIN 250MG CAPSULE 250MG CODAL SYNTO LTD CYPRUS<br />

SYNTONOL 40MG TABLET 40MG CODAL SYNTO LTD CYPRUS<br />

SYREA CAPSULE 500MG MEDAC GMBH GERMANY<br />

SYSCOR CC MODIFIED RELEASE<br />

TABLETS<br />

10MG BAYER PLC UNITED KINGDOM<br />

SYSTEN 50 (EVOREL) PATCH 3.2MG JANSSEN-CILAG AG SWITZERLAND<br />

SYSTRAL CREAM N/A ASTA MEDICA GERMANY<br />

SYTRON 27.5MG IRON PER 5ML ORAL SOLUTION 190MG/5ML LINK PHARMACEUTICALS<br />

LIMITED<br />

T & C SHAMPOO LOTION N/A HOE PHARMACEUTICALS<br />

SDN. BHD.<br />

TAB. AMLODIPINE BESYLATE TABLETS 5MG MACLEODS INDIA<br />

UNITED KINGDOM<br />

MALAYSIA<br />

TABROGYL TABLET 200MG TABROS PAKISTAN<br />

TADENAN 50MG CAPSULE 50MG LABORATOIRES DEBAT FRANCE<br />

TAGAMET INJECTABLE SOLUTION 200MG/2ML VIANEX S.A GREECE<br />

TAGAMET TABLET 200MG SMITH KLINE &<br />

BEECHAM<br />

TAGAMET 400 TABLET 400MG SMITH KLINE &<br />

BEECHAM<br />

TAGAMET 400MG TABLETS COATED TABLET 400MG SMITHKLINE & FRENCH<br />

LABORATORIES LIMITED<br />

TAGAMET INJECTION 200MG/2ML SOLUTION FOR<br />

INJECTION<br />

200MG/2ML SMITHKLINE & FRENCH<br />

LABORATORIES LIMITED<br />

TAGAMET SYRUP 4% W/V ORAL SOLUTION 4% W/V SMITHKLINE & FRENCH<br />

LABORATORIES LIMITED<br />

TAGAMET TABLETS 200MG COATED TABLET 200MG SMITHKLINE & FRENCH<br />

LABORATORIES LIMITED<br />

TAGAMET TABLETS 800MG COATED TABLET 800MG SMITHKLINE & FRENCH<br />

LABORATORIES LIMITED<br />

TALCO MENTOLATO CUTANEOUS POWDER 125G LABORATORIO CHIMICO<br />

FARMACEUTICO A.<br />

SELLA S.R.L<br />

PAKISTAN<br />

PAKISTAN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY


EN<br />

720 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TAMAGON FORTE TABLET 120MG MEDOCHEMIE LTD CYPRUS<br />

TAMBOCOR TABLET 100MG 3M HEALTH CARE<br />

LIMITED<br />

TAMBOCOR TABLETS 100 MG 3 M HEALTH CARE<br />

LIMITED<br />

TAMIFEN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS<br />

TAMIFEN DS TABLET 20MG MEDOCHEMIE LTD CYPRUS<br />

TAMIFLU CAPSULE 75MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

TAMOFEN TABLET 10MG LEIRAS PAKISTAN<br />

TAMOFEN TABLET 25MG LEIRAS PAKISTAN<br />

TAMOFEN 20MG TABLETS 20MG LEIRAS OY FINLAND<br />

TAMOXIFEN TABLETS 10MG NORTON HEALTHCARE<br />

LIMITED<br />

TAMOXIFEN TABLETS 20MG NORTON HEALTHCARE<br />

LIMITED<br />

TAMOXIFEN TABLETS 40MG NORTON HEALTHCARE<br />

LIMITED<br />

TAMOXIFEN TABLETS 10MG,20MG DOUGLAS<br />

PHARMACEUTICALS LTD<br />

TAMOXIFEN 10MG TABLET 10MG CODAL SYNTO LTD CYPRUS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

NEW ZEALAND<br />

TAMOXIFEN CITRATE TABLETS BP TABLETS 20MG GENERICS (UK) LTD. UNITED KINGDOM<br />

TAMOXIFEN TABLETS BP 10MG TABLETS 10MG CP PHARMACEUTICALS<br />

LTD.<br />

TAMOXIFEN TABLETS BP 10MG COATED TABLET 10 MG CP PHARMACEUTICALS<br />

LTD<br />

TAMOXIFEN TABLETS BP 20MG TABLETS 20MG CP PHARMACEUTICALS<br />

LTD.<br />

TAMOXIFEN TABLETS BP 20MG TABLET 20MG CP PHARMACEUTICALS<br />

LTD<br />

TAMOXIFEN TABLETS BP 40MG TABLETS 40MG CP PHARMACEUTICALS<br />

LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

TAMPOVAGAN PESSARY N/A CO-PHARMA LIMITED UNITED KINGDOM<br />

TANTUM ACTIV GOLA,<br />

COLLUTORIO<br />

COLLUTTORIO 0.25% AZ. CHIM. RIUN.<br />

ANGELINI FRANCESCO<br />

ACRAF SPA — ITALY<br />

TANTUM VERDE DENTAL PASTA DENTIFRICIA NA AZ. CHIM. RIUN.<br />

ANGELINI FRANCESCO<br />

ACRAF SPA — ITALY<br />

TANTUM VERDE P, PASTIGLIA PASTIGLIA 3MG AZ. CHIM. RIUN.<br />

ANGELINI FRANCESCO<br />

ACRAF SPA — ITALY<br />

TANTUM VERDE, COLLUTTORIO<br />

120ML<br />

COLLUTTORIO 120ML NA AZ. CHIM. RIUN.<br />

ANGELINI FRANCESCO<br />

ACRAF SPA — ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 721<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TANTUM VERDE, COLLUTTORIO<br />

240ML<br />

COLLUTTORIO 240ML NA AZ. CHIM. RIUN.<br />

ANGELINI FRANCESCO<br />

ACRAF SPA — ITALY<br />

TARGET GEL GEL 3% W/W CYANAMID UNITED KINGDOM<br />

TARGOCID 200MG POWDER FOR INJECTION 200MG LABORATOIRES MARION<br />

MERRELL DOW S.A.<br />

TARGOSID POWDER FOR IM<br />

INJECTION<br />

ITALY<br />

FRANCE<br />

200MG GRUPPO LEPETIT SPA ITALY<br />

TAROCTYL TABLETS 25MG TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD.<br />

TAROCTYL INJECTION SOLUTION FOR<br />

INJECTION<br />

TAROCTYL INJECTION 50MG/2ML SOLUTION FOR<br />

INJECTION<br />

50MG/2ML TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD.<br />

25MG/ML TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

TARODENT MOUTHWASH MOUTHWASH 0.2% W/V TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD.<br />

ISRAEL<br />

ISRAEL<br />

ISRAEL<br />

ISRAEL<br />

TAVANIC 250MG COATED TABLET 250MG LABORATOIRES AVENTIS FRANCE<br />

TAVANIC 500MG COATED TABLET 500MG LABORATOIRES AVENTIS FRANCE<br />

TAVANIC 5MG/ML SOLUTION FOR<br />

INFUSION<br />

5MG/ML LABORATOIRES<br />

ROUSSEL DIAMANT<br />

FRANCE<br />

TAVER 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS<br />

TAXOL INJECTABLE SOLUTION 30MG/5ML BRISTOL-MYERS SQUIBB<br />

EESTI AS<br />

TAXOL SOLN. FOR I.V INFUSION 30MG/5ML BRISTOL MYERS SQUIBB<br />

S.P.A<br />

TAXOTERE CONCENTRATE FOR<br />

INFUSION<br />

TAXOTERE CONCENTRATE FOR<br />

INFUSION<br />

TAXOTERE (DOCETAXEL) 20MG CONCENTRATE FOR<br />

INFUSION<br />

TAXOTERE (DOCETAXEL) 80MG CONCENTRATE FOR<br />

INFUSION<br />

20MG/0.5ML RHONE-POULENC<br />

RORER(FRANCE)<br />

80MG/2ML RHONE-POULENC<br />

RORER(FRANCE)<br />

N/A RHONE-POULENC RORER<br />

S.A.<br />

N/A RHONE-POULENC RORER<br />

S.A.<br />

TAZOCIN POWDER FOR INJECTION 2.25G CYANAMID OF GREAT<br />

BRITAIN LTD<br />

TAZOCIN POWDER FOR INJECTION 4.5G CYANAMID OF GREAT<br />

BRITAIN LTD<br />

TAZOCIN INJ. 2.25G POWDER FOR INJECTION N/A CYANAMID OF GREAT<br />

BRITAIN LTD.<br />

TAZOCIN INJ. 4.5G POWDER FOR INJECTION N/A CYANAMID OF GREAT<br />

BRITAIN LTD.<br />

TCK 1 KIT SOLUTION FOR<br />

INJECTION<br />

ESTONIA<br />

ITALY<br />

EUROPEAN COMMUNITY<br />

EUROPEAN COMMUNITY<br />

FRANCE<br />

FRANCE<br />

N/A CIS BIO INTERNATIONAL FRANCE<br />

TCK-7 KIT POWDER FOR INJECTION N/A CIS BIO INTERNATIONAL FRANCE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

722 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TCP LIQUID ANTISEPTIC LIQUID ANTISEPTIC N/A UNICLIFFE LIMITED T/A<br />

PFIZER CONSUMER<br />

HEALTHCARE<br />

TCP FIRST AID ANTISEPTIC<br />

CREAM<br />

UNITED KINGDOM<br />

CREAM N/A PFIZER LIMITED UNITED KINGDOM<br />

TCP OINTMENT OINTMENT N/A UNICLIFFE LIMITED T/A<br />

PFIZER CONSUMER<br />

HEALTHCARE<br />

TCP SORE THROAT LOZENGES LOZENGE N/A UNICLIFFE LIMITED T/A<br />

PFIZER CONSUMER<br />

HEALTHCARE<br />

TD-PUR SUSPENSION FOR<br />

INJECTION<br />

NA CHIRON BEHRING GMBH<br />

& CO.<br />

TEARS NATURALE FORTE LUBRICANT EYE DROPS N/A ALCON LABORATORIES<br />

INC<br />

TEARS NATURALE II/ADEQUAD EYE DROPS N/A S.A. ALCON-COUVREUR<br />

N.V.<br />

TEE TREE AND WITCH HAZEL<br />

CREAM<br />

CREAM N/A GR LANE HEALTH<br />

PRODUCTS LIMITED<br />

TEEJEL GEL GEL N/A MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

TEFAMIN SUPPOSITORY 360MG RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

TEFAMIN COATED TABLET 200MG RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

UNITED STATES OF<br />

AMERICA<br />

BELGIUM<br />

UNITED KINGDOM<br />

CYPRUS<br />

TEGRAL TABLET 200MG NOVARTIS PAKISTAN<br />

TEGRETOL TABLETS 200MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

ITALY<br />

ITALY<br />

SWITZERLAND<br />

TEGRETOL TABLET 200MG GEIGY PAKISTAN<br />

TEGRETOL SYRUP 100MG/5ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

TEGRETOL SYRUP 20MG/ML NOVARTIS FARMA —<br />

PRODUTOS<br />

FARMACEUTICOS S.A.<br />

SWITZERLAND<br />

PORTUGAL<br />

TEGRETOL DRINKABLE SUSPENSION 100MG/5ML NOVARTIS PHARMA S.A. FRANCE<br />

TEGRETOL TABLETS 200MG NOVARTIS FARMA —<br />

PRODUTOS<br />

FARMACEUTICOS S.A.<br />

TEGRETOL TABLETS 200MG NOVARTIS FARMA SPA ITALY<br />

TEGRETOL CR S.R. FILM COATED<br />

TABLETS<br />

TEGRETOL CR S.R. FILM COATED<br />

TABLET<br />

200MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

400MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

TEGRETOL CR DIVISIBLE TABLETS 400MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

TEGRETOL CR PROLONGED RELEASE<br />

TABLETS<br />

200MG NOVARTIS FARMA —<br />

PRODUTOS<br />

FARMACEUTICOS S.A.<br />

PORTUGAL<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

PORTUGAL


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 723<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TEGRETOL CR PROLONGED RELEASE<br />

TABLETS<br />

TEGRETOL CR PROLONGED RELEASE<br />

TABLETS<br />

200MG NOVARTIS FARMA SPA ITALY<br />

400MG NOVARTIS FARMA SPA ITALY<br />

TEGRETOL SYRUP SYRUP 100MG/5ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

TELAMENT PAEDIATRIC DROPS LIQUID 50MG/100ML ADCOCK INGRAM LTD SOUTH AFRICA<br />

TELFAST 120MG COATED TABLET 120MG LABORATOIRES MARION<br />

MERRELL S.A<br />

TELFAST 120MG TABLET 120MG HOECHST MARION<br />

ROUSSEL<br />

TELFAST 180MG COATED TABLET 180MG LABORATOIRES MARION<br />

MERRELL S.A.<br />

TELFAST 180MG TABLET 180MG HOECHST MARION<br />

ROUSSEL<br />

TEMAZEPAM TABLETS 10MG NORTON HEALTHCARE<br />

LIMITED<br />

TEMAZEPAM TABLETS 20MG NORTON HEALTHCARE<br />

LIMITED<br />

FRANCE<br />

PAKISTAN<br />

FRANCE<br />

PAKISTAN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

TEMAZEPAM TABLETS 10MG TABLETS 10MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

TEMODAL CAPSULE 5MG SCHERING<br />

CORPORATION<br />

TEMODAL CAPSULE 20MG SCHERING<br />

CORPORATION<br />

TEMODAL CAPSULE 100MG SCHERING<br />

CORPORATION<br />

TEMODAL CAPSULE 250MG SCHERING<br />

CORPORATION<br />

TENOLOL (ATENOLOL TABLETS<br />

BP)<br />

TABLET 100MG IPCA LABORATORIES<br />

LIMITED<br />

TENOMET 200 TABLETS 200MG REMEDICA LTD CYPRUS<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

TENORET TABLETS N/A ZENECA LIMITED UNITED KINGDOM<br />

TENORETIC TABLETS N/A ZENECA LIMITED UNITED KINGDOM<br />

TENORMIN TABLET 25MG ZENECA LIMITED UNITED KINGDOM<br />

TENORMIN COATED TABLET 50MG ZENECA LIMITED UNITED KINGDOM<br />

TENORMIN COATED TABLETS 100MG ZENECA LIMITED UNITED KINGDOM<br />

TENORMIN SOLUTION FOR<br />

INJECTIONS<br />

INDIA<br />

0.05%W/V ZENECA LIMITED UNITED KINGDOM<br />

TENORMIN 100MG TABLET 100MG ICI PAKISTAN<br />

TENORMIN 25MG TABLETS 25MG ICI PAKISTAN<br />

TENORMIN 25MG TABLETS FILM COATED TABLET 25MG ZENECA LIMITED UNITED KINGDOM<br />

TENORMIN 50MG TABLET 50MG ICI PAKISTAN<br />

TENORMIN TABLETS 100MG COATED TABLET 100MG ZENECA LIMITED UNITED KINGDOM


EN<br />

724 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TERACYCLINE BP 250MG TABLET 250MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

TERFENADINE TABLETS 60MG NORTON HEALTHCARE<br />

LIMITED<br />

TERIL 200MG TABLETS TABLET 200MG TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ISRAEL<br />

TERNOLOL FILM-COATED TABLET 100MG HOVID SDN BHD MALAYSIA<br />

TERRA-CORTIL OINTMENT N/A PFIZER LIMITED UNITED KINGDOM<br />

TERRA-CORTRIL NYSTATIN CREAM N/A PFIZER LIMITED UNITED KINGDOM<br />

TERRAMYCIN CAPSULES 250MG PFIZER LIMITED UNITED KINGDOM<br />

TERRAMYCIN TABLET 250MG PFIZER LIMITED UNITED KINGDOM<br />

TERRAMYCIN + POLYMYXIN B OPHTALMIC OINTMENT N/A PFIZER SA BELGIUM<br />

TERRAMYCIN+POLYMYXIN B TOPICAL OINTMENT N/A PFIZER SA BELGIUM<br />

TESTOSTERONE IMPLANT 100MG IMPLANT (SUB-CUTAN.<br />

USE)<br />

TESTOVIRON DEPOT 250 SOLUTION FOR<br />

INJECTION<br />

TESTOVIRON-DEPOT-250 OILY SOLN. FOR IM<br />

INJEC.<br />

TETANUS ANTITOXIN B.P. 1500IU SOLUTION FOR<br />

INJECTION<br />

TETANUS TOXOID VACCINE<br />

ADSORBED<br />

SOLUTION FOR<br />

INJECTION<br />

TETANUS VACCINE (ADSORBED) SOLUTION FOR<br />

INJECTION<br />

100MG ORGANON<br />

LABORATORIES LIMITED<br />

250MG SCHERING HEALTH CARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

250MG/ML SCHERING AG GERMANY<br />

1500IU M/S SERUM INSTITUTE<br />

OF INDIA LIMITED<br />

=>40IU M/S SERUM INSTITUTE<br />

OF INDIA LIMITED<br />

INDIA<br />

INDIA<br />

N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

TETAVAX SUSP F INJ PREFILLED SYR 40IU/0.5ML AVENTIS PASTEUR S.A FRANCE<br />

TETAVAX SUSP F INJ IN VIAL 40IU/0.5ML AVENTIS PASTEUR S.A FRANCE<br />

TETAVAX ADSORBED<br />

ANTI-TETANUS VACCINE<br />

INJECTABLE SUSPENSION 40IU/VACCINE PASTEUR MERIEUX FRANCE<br />

TETMOSOL SOAP 5% W/W ZENECA LIMITED UNITED KINGDOM<br />

TETRACOQ INJECTABLE SUSPENSION N/A PASTEUR MERIEUX FRANCE<br />

TETRACT HIB SUSPENSION FOR<br />

INJECTION<br />

N/A PASTEUR MERIEUX FRANCE<br />

TETRACYCLINE 250 CAPSULES 250MG AEGIS LTD. CYPRUS<br />

TETRACYCLINE BP 250MG CAPSULE 250MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

TETRADAR HYDROCHLORIDE<br />

250<br />

CAPSULE 250MG DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO. LTD<br />

UNITED KINGDOM<br />

JORDAN<br />

TETRALYSAL 150 CAPSULES CAPSULES 150MG GALDERMA (UK) LIMITED UNITED KINGDOM<br />

TETRALYSAL 300 CAPSULE 300MG GALDERMA (UK) LIMITED UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 725<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TETRAMIL OPHTHALMIC DROPS N/A FARMIGEA SPA ITALY<br />

TETSEPT THROAT PASTILLES<br />

FORTE<br />

PASTILLES N/A MERZ+CO. GMBH & CO. GERMANY<br />

TEVETEN 400 FILM COATED TABLET 400MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

TEVETEN 600 FILM COATED TABLET 600MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

NETHERLANDS<br />

NETHERLANDS<br />

THALAMONAL 2ML AMPOULE N/A JANSSEN-CILAG N.V. BELGIUM<br />

THALLOUS CHLORIDE (201TL)<br />

37MB/ML<br />

SOLUTION FOR<br />

INJECTIONS<br />

N/A NYCOMED AMERSHAM<br />

PLC<br />

THELMOX 100 TABLETS 100MG REMEDICA LTD CYPRUS<br />

THELMOX 500 TABLETS 500MG REMEDICA LTD CYPRUS<br />

THEO DUR TABLET 300MG RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

THEO DUR TABLET 200MG RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

THEO DUR MODIFIED RELEASE<br />

TABLET<br />

THEO DUR MODIFIED RELEASE<br />

TABLET<br />

200MG RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

300MG RECORDATI INDUSTRIA<br />

CHIMICA<br />

FARMACEUTICA S.P.A.<br />

THERACAP 131TM CAPSULE N/A NYCOMED AMERSHAM<br />

PLC<br />

THIAMINE SOLUTION FOR<br />

INJECTION<br />

100MG/2ML PHARMAMED<br />

PARENTERALS LTD.<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

UNITED KINGDOM<br />

MALTA<br />

THIAMINE HYDROCHLORIDE TABLET 50MG PHARMAMED LTD. MALTA<br />

THIOBACTIN COATED TABLET 250MG SANOFI WINTHROP FRANCE<br />

THIOBACTIN 750MG/5ML SOLUTION FOR<br />

INJECTION<br />

750MG/5ML SANOFI WINTHROP FRANCE<br />

THIORIDAZINE 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS<br />

THYMOGLOBULINE 5MG/ML INJECTABLE<br />

PREPARATION<br />

THYMOL GLYCERIN COMPOUND<br />

BP<br />

5MG/ML IMTIX-SANGSTAT FRANCE<br />

DENTAL SOLUTION N/A LCM LTD UNITED KINGDOM<br />

THYROX TABLETS 0.1MG MACLEODS<br />

PHARMACEUTICALS LTD<br />

THYROXIN 100MCG TABLETS TABLETS 100MCG FORLEY GENERICS LTD. UNITED KINGDOM<br />

THYROXIN 50MCG TABLETS TABLETS 50MCG FORLEY GENERICS LTD UNITED KINGDOM<br />

THYROXINE 100 MCG TABLETS 100 MCG GOLDSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

INDIA<br />

UNITED KINGDOM<br />

THYROXINE 100MCG TABLET 100MCG GOLDSHIELD GROUP PLC UNITED KINGDOM<br />

THYROXINE 50MCG TABLET 50MCG GOLDSHIELD GROUP PLC UNITED KINGDOM


EN<br />

726 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

THYROXINE TABLETS TABLET 25MCG CP PHARMACEUTICALS<br />

LTD<br />

THYROXINE TABLETS 100MCG TABLETS 100MCG APPROVED<br />

PRESCRIPTION SERVICES<br />

LIMITED<br />

THYROXINE TABLETS 50MCG BP TABLETS 50MCG APPROVED<br />

PRESCRIPTION SERVICES<br />

LIMITED<br />

THYROXINE TABLETS BP 25<br />

MICROGRAMS<br />

TABLETS 25MCG CP PHARMACEUTICALS<br />

LTD.<br />

THYROXINE TABLETS BP 50MCG TABLETS 50MCG MEDEVA PHARMA<br />

LIMITED<br />

TICEVIS TABLETS 10MG MEDOCHEMIE LTD. CYPRUS<br />

TICLID 250MG FILM-COATED TABLET 250MG SANOFI WINTHROP FRANCE<br />

TIENAM 500MG POWDER FOR INFUSION 500MG MERCK SHARP & DOHME<br />

CHIBRET<br />

TIENAM I.V. 250MG STERILE POWDER FOR<br />

INJECT<br />

250MG MERCK SHARP & DOHME<br />

B.V.<br />

TIGER BALM RED OINTMENT N/A HAW PAR HEALTHCARE<br />

LTD<br />

TIGER BALM WHITE OINTMENT N/A HAW PAR HEALTHCARE<br />

LTD<br />

TIGER LINIMENT TOPICAL SOLUTION N/A HAW PAR HEALTHCARE<br />

LTD<br />

TIGER MUSCLE RUB CREAM CREAM N/A HAW PAR HEALTHCARE<br />

LTD<br />

TILADE OR TILADE SYNCRONER MET. DOSE PRESS.<br />

AEROSOL<br />

2MG/ACTUATION FISONS LIMITED T/A<br />

RHONE-POULENC RORER<br />

TILADE OR TILADE SYNCRONER AERSOL 2.0MG/ACTUATION FISONS LTDT/A RHONE-<br />

POULENC RORER<br />

TILADE PLAIN MET. DOSE PRESS.<br />

AEROSOL<br />

TILDIEM 100MG POWDER FOR<br />

INJECTABLE SOL<br />

TILDIEM 25MG POWDER FOR<br />

INJECTABLE SOL<br />

2MG/ACTUATION FISONS PLC —<br />

PHARMACEUTICAL<br />

DIVISION<br />

100MG/VIAL LABORATOIRES<br />

SYNTHELABO<br />

25MG/VIAL LABORATOIRES<br />

SYNTHELABO<br />

TILDIEM 60MG TABLET 60MG LABORATOIRES<br />

SYNTHELABO<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

NETHERLANDS<br />

SINGAPORE<br />

SINGAPORE<br />

SINGAPORE<br />

SINGAPORE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

TILIDON FILM COATED TABLET 10MG PT INTERBAT INDONESIA<br />

TILIDON SYRUP 5MG/5ML PT INTERBAT INDONESIA<br />

TILIDON FILM-COATED TABLET 10MG PT INTERBAT INDONESIA<br />

TILIDON SYRUP SYRUP 60MG PT INTERBAT INDONESIA<br />

TIMABAK 0.25% COLLYRE (5ML) EYEDROPS 0.25% LABORATOIRES THEA FRANCE<br />

TIMABAK 0.50% COLLYRE (5ML) EYE DROPS 0.50% LABORATOIRES THEA FRANCE<br />

TIMENTIN 0.8G POWDER FOR INFUSION N/A BEECHAM GROUP PLC UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 727<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TIMENTIN 1.6G POWDER FOR INFUSION N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

TIMENTIN INJECTION 3.2G POWDER FOR INFUSION N/A BEECHAM GROUP PLC UNITED KINGDOM<br />

TIMET 200 TABLETS 200MG AEGIS LTD. CYPRUS<br />

TIMET 400 TABLETS 400MG AEGIS LTD. CYPRUS<br />

TIMO-COMOD 0.5% EYE DROPS 0.5% W/V URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

GERMANY<br />

TIMOLOL EYE DROPS 0.5% W/W PL 00156/0033 UNITED KINGDOM<br />

TIMOLOL EYE DROPS EYE DROPS 0.25% W/W NORTON HEALTHCARE<br />

LIMITED<br />

TIMOLOL EYE DROPS EYE DROPS 0.5%W/V NORTON HEALTHCARE<br />

LIMITED<br />

TIMOLOL MALEATE 0.25% EYE DROPS SOLUTION 0,25% EGYPTIAN<br />

INTERNATIONAL<br />

PHARMACEUTICAL<br />

INDUSTRIES CO (EIPICO)<br />

TIMOLOL MALEATE 0.5% EYE DROPS 0.5% EGYPTIAN<br />

INTERNATIONAL<br />

PHARMACEUTICAL<br />

INDUSTRIES CO (EIPICO)<br />

TIMOLOL-POS EYE DROPS 0.5% URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

TIMOPTOL 0.25% DPS EYE DROPS 0.25% W/V MERCK SHARP & DOHME<br />

B.V.<br />

TIMOPTOL 0.50% DPS EYE DROPS 0.50% W/V MERCK SHARP & DOHME<br />

B.V.<br />

TIMOPTOL-XE 0.25% DPS EYE DROPS 0.25% W/V MERCK SHARP & DOHME<br />

B.V.<br />

TIMOSOL EYE DROPS 0.5%W/W SEHAZOO<br />

LABORATORIES (PVT)<br />

LTD<br />

TIMOSOL 0.5% OPHTHALMIC SOLUTION 0.5% W/V BILIM ILAC SANAYII VE<br />

TICARET AS<br />

TIMOSOL GOZ DAMLASI STERILE OPHTHALMIC<br />

SOL'N<br />

0.5% BILIM ILAC SANAYII VE<br />

TICARET A.S.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

EGYPT<br />

EGYPT<br />

GERMANY<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

PAKISTAN<br />

TURKEY<br />

TURKEY<br />

TINADERM SOLUTION 10MG/ML S-P CANADA CANADA<br />

TINADERM CREAM 1% CREAM 1% W/W SCHERING-PLOUGH<br />

LIMITED<br />

TINADERM PLUS POWDER 1% TOPICAL POWDER 1% W/W SCHERING-PLOUGH<br />

LIMITED<br />

TINADERM PLUS POWDER<br />

AEROSOL<br />

TOPICAL SPRAY 0.09% W/W SCHERING-PLOUGH<br />

LIMITED<br />

TIRABICIN FILM-COATED TABLETS 150MG KLEVA LTD. GREECE<br />

TIRABICIN FILM COATED TABLETS 150MG KLEVA LIMITED GREECE<br />

TISSUCOL KIT — 2ML POWDER FOR INJECTION N/A SEE REMARKS BAXTER AG BELGIUM<br />

TISSUCOL KIT — 0.5ML KIT (SEE REMARKS) N/A BAXTER AG BELGIUM<br />

TISSUCOL KIT — 1ML KIT (SEE REMARKS) N/A BAXTER AG BELGIUM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

728 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TISSUCOL KIT — 5ML POWDER FOR INJECTION N/A SEE REMARKS BAXTER EG BELGIUM<br />

TITRALAC CHEWABLE TABLETS 420MG 3M HEALTH CARE<br />

LIMITED<br />

UNITED KINGDOM<br />

TITRALAC CHEWABLE TABLETS 420MG 3M HEALTHCARE LTD. UNITED KINGDOM<br />

TIXYLIX CHILDREN'S COUGH<br />

LINCTUS<br />

TL-201-S-1 SOLUTION FOR<br />

INJECTION<br />

TOBRADEX OPHTHALMIC<br />

SUSPENSION<br />

ORAL SOLUTION N/A MAY & BAKER LIMITED UNITED KINGDOM<br />

37MBQ/ML CIS BIO INTERNATIONAL FRANCE<br />

N/A S.A. ALCON-COUVREUR<br />

N.V<br />

TOBRADEX OPHTHALMIC OINTMENT N/A S.A ALCON-COUVREUR<br />

N.V.<br />

TOBRAMYCIN SOLUTION FOR<br />

INJECTION<br />

TOBRAMYCIN INJECTION BP SOLUTION FOR<br />

INJECTIONS<br />

TOBRAMYCIN INJECTION VIAL SOLUTION FOR<br />

INJECTION<br />

TOBRAMYCIN SULFATE<br />

INJECTION USP<br />

SOLUTION FOR<br />

INJECTION<br />

40MG/ML BP F.H.FAULDING & CO.<br />

LIMITED (T/A DAVID<br />

BULL LABORATORIES)<br />

40MG/ML FAULDING<br />

PHARMACEUTICALS PLC<br />

40MG/1ML F.H. FAULDING & CO LTD<br />

(T/A DAVID BULL LABS)<br />

BELGIUM<br />

BELGIUM<br />

AUSTRALIA<br />

UNITED KINGDOM<br />

AUSTRALIA<br />

80MG/2ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

TOBREX OPHTHALMIC SOLUTION 3MG/ML S.A. ALCON-COUVREUR<br />

N.V.<br />

TOBREX OPHTHALMIC OINTMENT 3MG/G S.A. ALCON-COUVREUR<br />

N.V.<br />

BELGIUM<br />

BELGIUM<br />

TOCLASE SYRUP 15MG/10ML U.C.B. S.A. BELGIUM<br />

TOCLASE SYRUP N/A UCB S.A. BELGIUM<br />

TOFRANIL SUGAR COATED<br />

TABLETS<br />

TOFRANIL SUGAR COATED<br />

TABLETS<br />

10MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

25MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

SWITZERLAND<br />

TOFRANIL TABLET 25MG GEIGY PAKISTAN<br />

TOFRANIL SUGAR-COATED<br />

TABLETS<br />

25MG NOVARTIS PHARMA<br />

GMBH<br />

AUSTRIA<br />

TOFRANIL 25MG TABLETS 25MG NOVARTIS PAKISTAN<br />

TOMUDEX POWDER FOR INJECTION 2MG ZENECA LIMITED UNITED KINGDOM<br />

TON WAS 10 DRINKABLE VIALS SOLUTION FOR ORAL<br />

USE<br />

NA CHIESI ESPANA S.A. SPAIN<br />

TONILAX COATED TABLETS N/A LABORATOIRES MONOT FRANCE<br />

TONOCALCIN SOLUTION FOR<br />

INJECTIONS<br />

TONOCALCIN SOLUTION FOR<br />

INJECTIONS<br />

100 IU ALFA WASSERMANN<br />

S.P.A.<br />

50 IU ALFA WASSERMANN<br />

S.P.A.<br />

TONOCEBRIN S/C TABLET N/A WALTER RITTER GMBH +<br />

CO.<br />

ITALY<br />

ITALY<br />

GERMANY


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 729<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TOPAMAX 100MG TABLET 100MG JANSSEN-CILAG AG SWITZERLAND<br />

TOPAMAX 200MG TABLET 200MG JANSSEN-CILAG AG SWITZERLAND<br />

TOPAMAX 25MG TABLET 25MG JANSSEN-CILAG AG SWITZERLAND<br />

TOPAMAX 300MG TABLET 300MG JANSSEN-CILAG AG SWITZERLAND<br />

TOPAMAX 400MG TABLET 400MG JANSSEN-CILAG AG SWITZERLAND<br />

TOPAMAX 50MG TABLET 50MG JANSSEN-CILAG AG SWITZERLAND<br />

TOPEX-25 TABLET 25MG CIPLA LTD INDIA<br />

TOPTABS TABLET N/A SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

TORBETOL ACNE LOTION TOPICAL SOLUTION N/A TORBET LABORATORIES<br />

LIMITED<br />

TORENTAL 100MG/5ML SOLUTION FOR<br />

INJECTION<br />

TORENTAL LP 400MG SUSTAINED RELEASE<br />

TABLET<br />

100MG/5ML LABORATOIRES<br />

HOECHST<br />

400MG LABORATOIRES<br />

HOECHST HOUDE<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

TOSCACALM TABLETS 20MG GENEPHARM S.A. GREECE<br />

TOSCAMYCIN-R TABLETS 150MG GENEPHARM S.A. GREECE<br />

TOTAFORTE CAPSULE N/A DAGRA PHARMA B.V NETHERLANDS<br />

TOTAMOL FILM COATED TABLET 50MG CP PHARMACEUTICALS<br />

LIMITED<br />

TOTAMOL TABLET 25MG CP PHARMACEUTICALS<br />

LIMITED<br />

TOTAMOL COATED TABLETS 100MG CP PHARMACEUTICALS<br />

LIMITED<br />

TOTAMOL TABLETS 100MG CP PHARMACEUTICALS<br />

LTD.<br />

TOTAMOL TABLETS 25MG CP PHARMACEUTICALS<br />

LTD.<br />

TOTAMOL TABLETS 50MG CP PHARMACEUTICALS<br />

LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

TOTAMOL 25MG TABLET 25MG CP PHARMA PAKISTAN<br />

TOTAMOL TABLET TABLET 50MG CP PHARMA P PAKISTAN<br />

TOTAMOL TABLET TABLET 100MG CPPHARMA PAKISTAN<br />

TOTARETIC TABLETS N/A CP PHARMACEUTICALS<br />

LTD.<br />

TOTARETIC TABLETS N/A CP PHARMACEUTICALS<br />

LTD.<br />

TOT'HEMA ORAL SOLUTION N/A LABORATOIRES<br />

INNOTHERA<br />

TOT'HEMA DRINKABLE SOLUTION NA LABORATOIRE<br />

INNOTECH<br />

INTERNATIONAL<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

TRACHISAN LOZENGES LOZENGE N/A KARL ENGELHARD GERMANY


EN<br />

730 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TRACHISAN SORE THROAT<br />

GARGLE<br />

SOLUTION N/A KARL ENGELHARD GERMANY<br />

TRACHITOL LOZENGES LOZENGES N/A KARL ENGELHARD GERMANY<br />

TRACRIUM SOLUTION FOR<br />

INJECTION<br />

TRACRIUM SOLUTION FOR<br />

INJECTION<br />

TRACRIUM SOLUTION FOR<br />

INJECTION<br />

TRACRIUM SOLUTION FOR<br />

INJECTION<br />

TRACRIUM SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

TRACUTIL CONCENTRATE F. SOL F.<br />

INF<br />

25MG/2.5ML THE WELLCOME<br />

FOUNDATION LIMITED<br />

50MG/5ML THE WELLCOME<br />

FOUNDATION LIMITED<br />

250MG/25ML THE WELLCOME<br />

FOUNDATION LIMITED<br />

25MG/2.5M THE WELLCOME<br />

FOUNDATION LTD<br />

50MG/5ML THE WELLCOME<br />

FOUNDATION LTD<br />

N/A B.BRAUN MELSUNGEN<br />

AG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

GERMANY<br />

TRAMADEX CAPSULES 50MG AEGIS LTD CYPRUS<br />

TRAMADOL SR CAPSULES 50MG ASTA MEDICA LTD UNITED KINGDOM<br />

TRAMADOL SR CAPSULES 100MG ASTA MEDICA LTD UNITED KINGDOM<br />

TRAMADOL SR CAPSULE 150MG ASTA MEDICA LTD UNITED KINGDOM<br />

TRAMADOL SR CAPSULES 200MG ASTA MEDICA LTD UNITED KINGDOM<br />

TRAMADOL HCL CAPSULES 50MG CAPSULE 50MG SANOFI WINTHROP<br />

LIMITED T/A STERWIN<br />

MEDICINES<br />

TRAMADOL HYDROCHLORIDE CAPSULES 50 MG BIOGLAN<br />

LABORATORIES LTD.<br />

TRAMADOL HYDROCHLORIDE<br />

CAPSULES 50MG<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

CAPSULE 50MG SANOFI WINTHROP LTD UNITED KINGDOM<br />

TRAMAKE CAPSULE 50MG GALEN LIMITED UNITED KINGDOM<br />

TRAMAL 100 SOLUTION FOR<br />

INJECTION<br />

100MG/2ML GRUNENTHAL GERMANY<br />

TRAMAL CAPSULE CAPSULE 50MG SEARLE PAKISTAN<br />

TRAMAL CAPSULES CAPSULES 50MG GRUNENTHAL GMBH GERMANY<br />

TRAMAL DROPS SOLUTION 100MG/ML GRUNENTHAL GMBH GERMANY<br />

TRAMAL RETARD 100MG FILM-COATED TABLETS 100MG GRUNENTHAL GMBH GERMANY<br />

TRAMAL SUPPOSITORIES SUPPOSITORY 100MG GRUNENTAL GMBH GERMANY<br />

TRAMUDIN CAPSULES CAPSULES FOR ORAL<br />

USE<br />

TRAMUDIN RETARD TABLETS<br />

100MG<br />

RETARD TABLETS / ORAL<br />

USE<br />

50MG MUNDIPHARMA GMBH GERMANY<br />

100MG MUNDIPHARMA GMBH GERMANY<br />

TRANSACALM TABLETS 100MG LABORATOIRES A.J.C.<br />

PHARMA<br />

TRANSVASIN HEAT RUB CREAM CREAM N/A SETON PRODUCTS<br />

LIMITED<br />

FRANCE<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 731<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TRANSVASIN HEAT SPRAY TOPICAL SPRAY N/A SETON HEALTHCARE<br />

GROUP PLC<br />

TRANXENE 10MG CAPSULE 10MG SANOFI WINTHROP FRANCE<br />

TRANXENE 5MG CAPSULE 5MG SANOFI WINTHROP FRANCE<br />

TRASYLOL 100,000KIU/5ML SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

100,000KIU/5ML BAYER AG GERMANY<br />

TRASYLOL 500,000KIU/50ML INFUSION SOLUTION 500,000KIU/50ML BAYER VITAL GMBH &<br />

CO. KG<br />

TRAUMON GEL 100MG/G BAYER VITAL GMBH &<br />

CO. KG<br />

GERMANY<br />

GERMANY<br />

TRAUMON GEL 100MG/1G TROPON GMBH GERMANY<br />

TRAVATAN EYE DROPS SOLUTION 40MCG/ML ALCON LABORATORIES<br />

UK LIMITED<br />

TRAVATAN OPHTHALMIC<br />

SOLUTION<br />

OPHTHALMIC SOLUTION 0.004% ALCON UNIVERSAL LTD.<br />

C/O ALCON RESEARCH<br />

LTD<br />

TRAVILAN POWDER FOR INJECTION 1000MG ANFARM HELLAS S.A. GREECE<br />

TRAVOCORT CREAM N/A H.E. CLISSMAN IRELAND<br />

EUROPEAN COMMUNITY<br />

UNITED STATES OF<br />

AMERICA<br />

TRAVOCORT CREAM N/A SCHERING AG GERMANY<br />

TRAVOCORT CREAM N/A SCHERING SPA ITALY<br />

TRAVOCORT CREAM N/A SCHERING PAKISTAN<br />

TRAVOCORT CREAM CREAM N/A SCHERING PAKISTAN<br />

TRAVOGEN CREAM 10MG/G SCHERING AG GERMANY<br />

TRAVOGEN CREAM 1MG/100G SCHERING SPA ITALY<br />

TRAVOGEN CREAM CREAM 10MG/G SCHERING PAKISTAN<br />

TRAVOGEN CREAM CREAM 10MG/10G SCHERING PAKISTAN<br />

TREDOL 100 TABLETS 100MG AEGIS LTD. CYPRUS<br />

TREDOL 25 TABLETS 25MG AEGIS LTD. CYPRUS<br />

TREDOL 50 TABLETS 50MG AEGIS LTD. CYPRUS<br />

TRIACANA TABLET 0.35MG LABORATORIES LAPHAL FRANCE<br />

TRIAMCO TABLETS N/A NORTON HEALTHCARE<br />

LIMITED<br />

TRIATEC 2.5MG CAPSULE 2.5MG LABORATOIRES<br />

HOECHST<br />

TRIATEC 5MG CAPSULE 5MG LABORATOIRES<br />

HOECHST<br />

TRIATEC FAIBLE 1.25MG CAPSULE 1.25MG LABORATOIRES<br />

HOECHST<br />

TRIDIL SOLUTION FOR IV<br />

INFUSION<br />

5MG/ML FAULDING PUERTO RICO<br />

INC<br />

TRIENE CREAM 5G/100G ALFA WASSERMANN<br />

S.P.A.<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

UNITED STATES OF<br />

AMERICA<br />

ITALY


EN<br />

732 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TRIFLUOPERAZINE TABLETS 1MG NORTON HEALTHCARE<br />

LIMITED<br />

TRIFLUOPERAZINE TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

TRIFLUOPERAZINE 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS<br />

TRIFLUOPERAZINE 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

TRIHERPINE EYE DROPS 10MG/ML CIBA VISION AG SWITZERLAND<br />

TRIHERPINE EYE OINTMENT 10MG/G CIBA VISION AG SWITZERLAND<br />

TRIIODOTHYRONINE POWDER FOR INJECTION 20 MCG GOLDSHIELD GROUP PLC<br />

T/A GOLDSHIELD<br />

PHARMACEUTICALS<br />

TRIIODOTHYRONINE INJECTION<br />

20MCG<br />

POWDER FOR INJECTION 2MCG GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED<br />

TRILEPTAL FILM COATED TABLETS 150MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

TRILEPTAL FILM COATED TABLETS 300MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

TRILEPTAL FILM COATED TABLETS 600MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

TRILEPTAL ORAL SUSPENSION N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

TRIMETABOL SOLUTION ORAL SUSPENSION N/A J.URIACH & CIA. S.A. SPAIN<br />

TRIMIDAR M ORAL SUSPENSION NA DAR AL DAWA<br />

DEVELOPMENT AND<br />

INVESTMENT CO LTD<br />

TRINORDIOL TABLETS NA JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

TRINORDIOL TABLETS N/A JOHN WYETH AND<br />

BROTHER LIMITED T/A<br />

WYETH LABORATORIES<br />

—UK<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

JORDAN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

TRINORDIOL 21 COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY<br />

TRINOVIN TABLET 200MG NOVOGEN<br />

LABORATORIES PTY LTD<br />

AUSTRALIA<br />

TRISEQUENS FORTE -28 TABLETS TABLET NA NOVO NORDISK A/S DENMARK<br />

TRISEQUENS-28TABLETS TABLET NA NOVO NORDISK A/S DENMARK<br />

TRITANRIX SUSPENSION FOR<br />

INJECTION<br />

TRITANRIX HEPB SUSPENSION FOR<br />

INJECTION<br />

TRIVASTAL RETARD 50 SUST. REL. COATED<br />

TABLET<br />

TRIVAX-AD SOLUTION FOR<br />

INJECTION<br />

N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

NA SMITHKLINE BEECHAM<br />

BIOLOGICALS S.A.<br />

50MG LES LABORATOIRES<br />

SERVIER<br />

BELGIUM<br />

EUROPEAN COMMUNITY<br />

FRANCE<br />

N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

TRIVEDON-20 TABLET 20MG CIPLA LIMITED INDIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 733<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TRIZOLIN 400 TABLETS 400MG REMEDICA LTD CYPRUS<br />

TROBICIN SUSPENSION FOR<br />

INJECTION<br />

2G/3.2ML PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

TROFOGIN CREAM VAGINAL N/A FARMIGEA SPA -ITALY ITALY<br />

TROPEX EAR DROPS 5% W/V ROWA<br />

PHARMACEUTICALS LTD<br />

TROPIMIL OPHTHALMIC DROPS 0.5G/100ML FARMIGEA SPA ITALY<br />

BELGIUM<br />

IRELAND<br />

TROPIXAL EYE DROPS SOLUTION 0.5% W/V DEMO ABEE GREECE<br />

TRUSOPT 2% OPHTHALMIC SOLUTION 2% W/V MERCK SHARP & DOHME<br />

B.V.<br />

NETHERLANDS<br />

TRYPTANOL TABLET 10MG M.S.D. PAKISTAN<br />

TRYPTANOL TABLET 25MG M.S.D. PAKISTAN<br />

TRYPTIZOL 10MG TABLET 10MG MERCK SHARP & DOHME<br />

B.V.<br />

TRYPTIZOL 25MG TABLET 25MG MERCK SHARP & DOHME<br />

B.V.<br />

TUBERCULIN PPD DILUTIONS<br />

MANTOUX<br />

TUBERCULIN PPD DILUTIONS<br />

MANTOUX<br />

SOLUTION FOR<br />

INJECTIONS<br />

SOLUTION FOR<br />

INJECTION<br />

TUBERCULIN PPD RT 23 SSI SOLUTION FOR<br />

INJECTION<br />

TUBERCULIN PPD UNDILUTED<br />

HEAF<br />

TUBERCULIN PPD UNDILUTED<br />

MANTOUX<br />

TUBERSOL TUBERCULIN<br />

PPD(MANTOUX)<br />

SOLUTION FOR<br />

INJECTION<br />

NETHERLANDS<br />

NETHERLANDS<br />

N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

2T.U./0.1ML STATENS SERUM<br />

INSTITUT<br />

DENMARK<br />

N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

SOUTION FOR INJECTION N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />

LIQUID FOR INJECTION N/A AVENTIS PASTEUR<br />

LIMITED<br />

CANADA<br />

TULOTRACT LIQUID 66,7G/100ML ARDEYPHARM GMBH GERMANY<br />

TUPAST FILM COATED TABLETS 150MG KLEVA LTD. GREECE<br />

TUPAST FILM COATED TABLETS 150MG KLEVA LIMITED GREECE<br />

TUPAST FILM COATED TABLETS 300MG KLEVA LIMITED GREECE<br />

TUSCALMAN BERNA DROPS N/A SWISS SERUM AND<br />

VACCINE INSTITUTE<br />

BERNE<br />

TUSCALMAN BERNA SYRUP N/A SWISS SERUM AND<br />

VACCINE INSTITUTE<br />

BERNE<br />

TUSCALMAN BERNA A SUPPOSITORIES N/A SWISS SERUM AND<br />

VACCINE INSTITUTE<br />

BERNE<br />

TUSCALMAN BERNA B SUPPOSITORIES N/A SWISS SERUM AND<br />

VACCINE INSTITUTE<br />

BERNE<br />

TWINRIX PAEDIATRIC SUSPENSION FOR<br />

INJECTION<br />

N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS S.A.<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

BELGIUM


EN<br />

734 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

TWINRIX-ADULT SUSPENSION FOR<br />

INJECTION<br />

N/A SMITHKLINE BEECHAM<br />

BIOLOGICALS S.A.<br />

EUROPEAN COMMUNITY<br />

TYLENOL DROPS 100MG/ML JANSSEN-CILAG AG SWITZERLAND<br />

TYLENOL 100MG SUPPOSITORY 100MG JANSSEN-CILAG AG SWITZERLAND<br />

TYLENOL 200MG SUPPOSITORY 200MG JANSSEN-CILAG AG SWITZERLAND<br />

TYLENOL 350MG SUPPOSITORY 350MG JANSSEN-CILAG AG SWITZERLAND<br />

TYLENOL FORTE CAPLET 500MG JANSSEN-CILAG AG SWITZERLAND<br />

TYLENOL FORTE TABLET 500MG JANSSEN-CILAG AG SWITZERLAND<br />

TYPHERIX SOLUTION FOR<br />

INJECTION<br />

TYPHERIX SOLUTION FOR<br />

INJECTION<br />

TYPHIM VI SOLUTION FOR<br />

INJECTION<br />

50MCG/ML SMITHKLINE BEECHAM<br />

PLC<br />

25MCG/0.5ML SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

UNITED KINGDOM<br />

BELGIUM<br />

0.025MG/0.5ML PASTEUR MERIEUX FRANCE<br />

TYPOFEN TABLETS N/A KLEVA LTD. GREECE<br />

TYPOFEN TABLETS N/A KLEVA LTD GREECE<br />

TYROCOMBIN OINTMENT N/A SYNPHARMA AG SWITZERLAND<br />

TYROCOMBIN POWDER N/A SYNPHARMA AG SWITZERLAND<br />

TYROSUR OINTMENT N/A KARL ENGELHARD GERMANY<br />

TYROSUR POWDER POWDER 1MG/G KARL ENGELHARD GERMANY<br />

UBRETID TABLETS 5MG NYCOMED AUSTRIA<br />

GMBH<br />

AUSTRIA<br />

UFEXIL TABLETS 250MG DEMO ABEE GREECE<br />

UFEXIL SOLUTION FOR<br />

INJECTION<br />

UFEXIL SOLUTION FOR<br />

INFUSION<br />

200MG/100ML DEMO ABEE GREECE<br />

100MG/50ML DEMO ABEE GREECE<br />

UKIDAN 100'000IU POWDER FOR INJECTION N/A LABORATOIRES SERONO<br />

SA<br />

SWITZERLAND<br />

ULCERAN 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS<br />

ULCESEP TABLETS 20MG ESPECIALIDADES<br />

FARMACEUTICAS<br />

CENTRUM SA<br />

ULCESEP TABLETS 20MG LABORATOIRES<br />

CENTRUM<br />

ULCOMET 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS<br />

ULCOMET 300MG/2ML LIQUID FOR INJECTION 300MG/2ML MEDOCHEMIE LTD CYPRUS<br />

ULTAC-150 TABLET 150MG CIPLA LIMITED INDIA<br />

ULTICADEX TABLET 5MG RAFARM GREECE<br />

ULTICADEX TABLET 20MG RAFARM GREECE<br />

ULTIVA FOR INJECTION<br />

1MG/VIAL<br />

SPAIN<br />

SPAIN<br />

POWDER FOR INJECTION 1MG/ML GLAXO GROUP LIMITED UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 735<br />

ULTIVA FOR INJECTION<br />

2MG/VIAL<br />

ULTIVA FOR INJECTION<br />

5MG/VIAL<br />

Trade Name Dosage Form Dose MA Holder Country<br />

POWDER FOR INFUSION 2MG GLAXO GROUP LIMITED UNITED KINGDOM<br />

POWDER FOR INFUSION 5MG GLAXO GROUP LIMITED UNITED KINGDOM<br />

ULTRACORTENOL EYE DROPS 5MG/ML CIBA VISION AG SWITZERLAND<br />

ULTRACORTENOL EYE DROPS 5.00MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

SWITZERLAND<br />

ULTRALAN TABLET 20MG SCHERING AG GERMANY<br />

ULTRALAN TABLET 5MG SCHERING AG GERMANY<br />

ULTRATARD HM SUSPENSION FOR<br />

INJECTION<br />

ULTRAVIST-240 SOLN. FOR IV INJEC./<br />

INFUS<br />

ULTRAVIST-300 SOLN. FOR IV INJEC./<br />

INFUS<br />

100IU/ML NOVO NORDISK A/S DENMARK<br />

498.72MG/ML SCHERING AG GERMANY<br />

623.4MG/ML SCHERING AG GERMANY<br />

ULTRAVIST-370 SOLN. FOR IV INJ./INFUS 768.86MG/ML SCHERING AG GERMANY<br />

UMAN ALBUMIN SOLUTION FOR<br />

INFUSION<br />

20% FARMA BIAGINI S.P.A ITALY<br />

UMODER TABLETS 100MG RAFARM GREECE<br />

UNIBUTOL TABLETS 400MG KOREA UNITED PHARM.<br />

INC.<br />

KOREA REPUBLIC<br />

UNICAP M TABLET N/A UPJOHN PAKISTAN<br />

UNICAP M TABLETS N/A PHARMACIA & UPJOHN<br />

LTD.<br />

UNIDERM CREAM 2%W/W RAZA MANUFACTURING<br />

BERHAD<br />

UNIFLU TABLETS; GREGOVITE 'C'<br />

TABLETS<br />

UNIMED CHLORAMPHENICOL<br />

SOLUTION<br />

COATED TAB;<br />

CHEWABLE TAB.<br />

UNITED KINGDOM<br />

MALAYSIA<br />

N/A UNIGREG LIMITED UNITED KINGDOM<br />

EYE DROPS 5MG/ML UNIMED<br />

PHARMACEUTICALS INC.<br />

UNIMED CIPROFLOXACIN TAB. TABLET 250MG UNIMED<br />

PHARMACEUTICALS INC.<br />

UNIMED GENTAMICIN SULFATE<br />

EYEDROPS<br />

UNIPARIN FORTE SOLUTION FOR<br />

INJECTION<br />

UNIPARIN-CA 5000IU/0.2ML SOLUTION FOR<br />

INJECTION<br />

UNIPHYLLIN CONTINUS TABLETS<br />

200MG<br />

UNIPHYLLIN CONTINUS TABLETS<br />

300MG<br />

UNIPHYLLIN CONTINUS TABLETS<br />

400MG<br />

EYEDROPS 3MG/ML UNIMED<br />

PHARMACEUTICALS INC.<br />

MODIFIED RELEASE<br />

TABLET<br />

MODIFIED RELEASE<br />

TABLET<br />

MODIFIED RELEASE<br />

TABLET<br />

UNIPLATIN (CARBOPLATIN) SOLUTION FOR<br />

INJECTION<br />

10000IU/0.4ML CP PHARMACEUTICALS<br />

LTD<br />

25000IU/ML CP PHARMACEUTICALS<br />

LTD<br />

200MG NAPP LABORATORIES<br />

LIMITED<br />

300MG NAPP LABORAOIES<br />

LIMITED<br />

400MG NAPP LABORATORIES<br />

LIMITED<br />

10MG/ML UNIMED<br />

PHARMACEUTICALS INC.<br />

KOREA REPUBLIC<br />

KOREA REPUBLIC<br />

KOREA REPUBLIC<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

KOREA REPUBLIC


EN<br />

736 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

UNIROID-HC OINTMENT OINTMENT N/A UNIGREG LIMITED UNITED KINGDOM<br />

UNIROID-HC SUPPOSITORIES SUPPOSITORY N/A UNIGREG LIMITED UNITED KINGDOM<br />

UPRIMA SUBLINGUAL TABLETS NA ABBOTT LABORATORIES<br />

LIMITED<br />

UPSA BUFFERED EFF. ASPIRIN<br />

WITH VIT. C<br />

SCORED EFF. TABLETS N/A LABORATOIRES UPSA FRANCE<br />

UPSA C EFFERVESCENT TABLETS EFFERVESCENT TABLETS 1000MG LABORATOIRES UPSA FRANCE<br />

URACTONUM 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS<br />

URAMOX TABLETS 250MG TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD.<br />

URAMOX 250MG TALETS TABLET 250MG TARO<br />

PHARMACEUTICAL<br />

INDUSTRIES LTD<br />

URBANYL TABLET 10MG HOECHST MARION<br />

ROUSSEL S.A.<br />

URDOX TABLETS 300MG COATED<br />

TABLETS<br />

300MG TABLETS CP PHARMACEUTICALS<br />

LTD<br />

UNITED KINGDOM<br />

ISRAEL<br />

ISRAEL<br />

TUNISIA<br />

URIGON E.C. TABLETS 25MG DEMO ABEE GREECE<br />

URIGON SOLUTION FOR<br />

INJECTION<br />

75MG/3ML DEMO ABEE GREECE<br />

URISPAS 200 COATED TABLET 200MG SHIRE<br />

PHARMACEUTICALS LTD<br />

URITAB TABLETS 100MG RAZA MANUFACTURING<br />

BERHAS<br />

UROKINASE 10 000 HS MEDAC POWDER F/SOLUTION<br />

FOR INJ<br />

UROKINASE 100 000 HS MEDAC POWDER F/SOLUTION<br />

FOR INJ<br />

UROMITEXAN SOLUTION FOR<br />

INJECTION<br />

10 000 HS MEDAC GESELLSCHAFT<br />

FUR KLINISCHE<br />

SPEZIALPRAPARATE MBH<br />

100 000 HS MEDAC GESELLSCHAFT<br />

FUR KLINISCHE<br />

SPEZIALPRAPARATE MBH<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

MALAYSIA<br />

GERMANY<br />

GERMANY<br />

400MG/4ML ASTA MEDICA GERMANY<br />

UROTRACTIN CAPSULE 400MG POLIPHARM CO. LTD. THAILAND<br />

UROVIDEO SOLUTION FOR IV<br />

INFUSION<br />

60% W/V BRACCO S.P.A. ITALY<br />

URSOFALK CAPSULES 250MG DR. FALK PHARMA<br />

GMBH<br />

GERMANY<br />

URSOGAL CAPSULES 250MG GALEN LIMITED UNITED KINGDOM<br />

URSOGAL TABLETS 150MG GALEN LIMITED UNITED KINGDOM<br />

UTABON ADULTS NASAL SPRAY,<br />

SOLUTION<br />

50MG/100ML J.URIACH & CIA. S.A. SPAIN<br />

UTABON CHILDREN NASAL DROPS,SOLUTION 25MG/100ML J.URIACH & CIA. S.A. SPAIN<br />

UTOVLAN TABLET 5MG MONSANTO PLC T/A<br />

SEARLE<br />

UTOVLAN TABLETS 5MG MONSANTO PLC T/A<br />

SEARLE<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 737<br />

Trade Name Dosage Form Dose MA Holder Country<br />

UTROGESTAN 100MG SOFT CAPSULE 100MG BESINS INTERNATIONAL FRANCE<br />

UZIX INJECTABLE SOLUTION 500MG/2ML RAFARM GREECE<br />

VACCIN BCG INSTITUT MERIEUX SOLUTION FOR<br />

INJECTION<br />

N/A PASTEUR MERIEUX FRANCE<br />

VACCIN POLIOMYELITIQUE ORAL ORAL SOLUTION N/A LABORATORIES<br />

PASTEUR MERIEUX<br />

FRANCE<br />

VACONTIL 2MG CAPSULE 2MG MEDOCHEMIE LTD CYPRUS<br />

VACONTIL 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS<br />

VAFLUSON KETOCONAZOLE 200MG KLEVA LTD GREECE<br />

VAGIFEM -15 APPLICATORS WITH<br />

INSERTS<br />

TABLET 25UG NOVO NORDISK A/S DENMARK<br />

VAGILEN VAGINAL PESSARY 500MG FARMIGEA S.P.A. ITALY<br />

VAGILEN CAPSULE 250MG FARMIGEA SPA ITALY<br />

VAGISIL MEDICATED CREME CREAM 2%W/W COMBE INTERNATIONAL<br />

LIMITED<br />

VAGOCLYSS SOLUTION (VAGINAL<br />

DOUCHE)<br />

10MG/ML DR.GROSSMANN AG<br />

PHARMACA<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

VALERIAN COMPOUND TABLETS COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM<br />

VALERIANA SCHIAPPARELLI COATED TABLETS 100MG ALFA WASSERMANN<br />

S.P.A.<br />

VALERIANA SCHIAPPARELLI COATED TABLETS 100MG ALFA WASSERMANN<br />

S.P.A.<br />

VALIREM TABLET 50MG GENEPHARM S.A GREECE<br />

VALIUM 2MG TABLET 2MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

VALIUM 5MG TABLET 5MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

ITALY<br />

ITALY<br />

SWITZERLAND<br />

SWITZERLAND<br />

VALIUM ROCHE 2MG TABLETS 2MG PRODUITS ROCHE FRANCE<br />

VALIUM ROCHE 5MG TABLETS 5MG LABORATOIRE<br />

PRODUITS ROCHE<br />

VALLERGAN FORTE SYRUP SYRUP 0.6%W/V CASTLEMEAD<br />

HEALTHCARE LIMITED<br />

VALLERGAN FORTE SYRUP SYRUP 0.6%W/V CASTLEMEAD<br />

HEALTHCARE LTD<br />

VALLERGAN SYRUP SYRUP 0.15% W/V CASTLEMEAD<br />

HEALTHCARE<br />

VALLERGAN SYRUP 0.15%W/V SYRUP 0.15%W/W CASTLEMEAD<br />

HEALTHCARE LIMITED<br />

VALOID INJECTION (CYCLIZINE<br />

LACTATE INJ.<br />

SOLUTION FOR<br />

INJECTION<br />

50MG/ML THE WELLCOME<br />

FOUDATION LIMITED<br />

FRANCE<br />

UNITED KINGDOM<br />

IRELAND<br />

IRELAND<br />

VALORAN 1G POWDER FOR INJECTION 1G MEDOCHEMIE LTD CYPRUS<br />

VALPROL-EC-500 TABLETS 500MG INTAS<br />

PHARMACEUTICALS LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

INDIA


EN<br />

738 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

VALTREX FILM-COATED TABLETS 500MG WELLCOME<br />

FARMACEUTICA S.A.<br />

VALTREX TABLETS 500MG COATED TABLETS 500MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

VAMIN 18 ELECTROLYTE FREE SOLUTION FOR<br />

INFUSION<br />

VAMIN 9 GLUCOSE SOLUTION FOR<br />

INFUSION<br />

VAMIN 9 GLUCOSE SOLUTION FOR<br />

INFUSION<br />

SPAIN<br />

UNITED KINGDOM<br />

N/A FRESENIUS KABI LIMITED UNITED KINGDOM<br />

N/A FRESENIUS KABI LIMITED UNITED KINGDOM<br />

NA FRESENIUS KABI LIMITED UNITED KINGDOM<br />

VAMIN-GLUKOS INTRAVENOUS INFUSION N/A PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

SWEDEN<br />

VANCOCIN CAPSULE 125MG ELI LILLY & COMPANY UNITED KINGDOM<br />

VANCOMICINA COMBINO PHARM POWDER FOR IV 500MG COMBINO PHARM SL SPAIN<br />

VANCOMYCIN CP LILLY 500 POWDER FOR INFUSION 500,000IU LILLY DEUTSCHLAND<br />

GMBH<br />

VANCOMYCIN INJECTION POWDER FOR INJECTION 500MG F.H. FAULDING & CO LTD<br />

(T/A DAVID BULL LABS)<br />

VANCOMYCINE MERCK 500MG POWDER FOR IV<br />

PERFUSION<br />

VANCOX POWDER FOR INJ.<br />

SOLUTION<br />

GERMANY<br />

500MG / VIAL MERCK GENERIQUES FRANCE<br />

500MG/1000MG LEMERY S.A. DE C.V. MEXICO<br />

VANCOZINE POWDER FOR INJECTION 500MG KOREA UNITED PHARM.<br />

INC.<br />

VARICOGEL GEL N/A ALFA WASSERMANN<br />

S.P.A.<br />

VARILIX POWDER FOR INJECTION >=2000PFU/0.5ML SMITHKLINE BEECHAM<br />

BIOLOGICALS<br />

VARITECT CP SOLUTION FOR<br />

INTRAVENOUS<br />

ADMINISTRATION<br />

UNITED KINGDOM<br />

KOREA REPUBLIC<br />

ITALY<br />

BELGIUM<br />

N/A BIOTEST PHARMA GMBH GERMANY<br />

VASCOTEN 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS<br />

VASCULIN CAPSULE 10MG GEOFMAN<br />

PHARMACEUTICALS<br />

VASEXTEN 10 MODIFIED RELEASE<br />

CAPSULES<br />

VASEXTEN 20 MODIFIED RELEASE<br />

CAPSULES<br />

10MG YAMANOUCHI PHARMA<br />

B.V.<br />

20MG YAMANOUCHI PHARMA<br />

B.V.<br />

PAKISTAN<br />

NETHERLANDS<br />

NETHERLANDS<br />

VASOGEN CREAM N/A PHARMAX LIMITED UNITED KINGDOM<br />

VASOPOS N EYE DROPS 0.5MG/ML URSAPHARM<br />

ARZNEIMITTEL GMBH<br />

VASOPRIL-20 TABLETS 20MG CIPLA LTD INDIA<br />

VASORINIL NASAL SPRAY,<br />

SOLUTION<br />

0.1G/100ML FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

VASOTOP TABLET 30MG CIPLA LTD. INDIA<br />

VASOXINE SOLUTION FOR<br />

INJECTION<br />

2MG/ML THE WELLCOME<br />

FOUNDATION LTD.<br />

GERMANY<br />

ITALY<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 739<br />

Trade Name Dosage Form Dose MA Holder Country<br />

VASTAREL 20MG COATED TABLET 20MG LES LABORATOIRES<br />

SERVIER<br />

VASTAREL 20MG/ML ORAL SOLUTION, DROPS 20MG/ML LES LABORATOIRES<br />

SERVIER<br />

VASTAREL MR MODIFIED RELEASE FC<br />

TABS<br />

35MG LES LABORATOIRES<br />

SERVIER<br />

VAXEM HIB INJECTABLE SOLUTION N/A CHIRON S.P.A. ITALY<br />

VAXIGRIP SUSPENSION FOR<br />

INJECTION<br />

VAXIGRIP SUSPENSION FOR<br />

INJECTION<br />

VECTARION 50MG FILM-COATED TABLET<br />

SCORED<br />

FRANCE<br />

FRANCE<br />

FRANCE<br />

N/A AVENTIS PASTEUR S.A. FRANCE<br />

NA AVENTIS PASTEUR S.A. FRANCE<br />

50MG LES LABORATOIRES<br />

SERVIER<br />

VECTAVIR CREAM N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

VEINAMITOL POWDER FOR BOUVABLE<br />

SOLN.<br />

FRANCE<br />

SWITZERLAND<br />

3500MG LABORATOIRES NEGMA FRANCE<br />

VEINAMITOL POWDER FOR ORAL SOL 3.5G/SACHET NEGMA-LERADS FRANCE<br />

VELBE POWDER FOR IV<br />

INJECTION<br />

10MG LILLY FRANCE S.A. FRANCE<br />

VENLOR-37.5 TABLETS 37.5MG CIPLA INDIA<br />

VENOGAMMA POWDER FOR SOL FOR<br />

INF.I<br />

0.06G/ML FINNISH RED CROSS<br />

BLOOD TRANSFUSION<br />

SERVICE<br />

VENORUTON GEL 20MG/G NOVARTIS CONSUMER<br />

HEALTH SA<br />

VENORUTON 300 CAPSULES 300MG NOVARTIS CONSUMER<br />

HEALTH SA<br />

VENOSMINE POMATA 4%W/W GEYMONAT SPA ITALY<br />

VENOSMINE TABLETS 450MG GEYMONAT SPA ITALY<br />

FINLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

VENTEZE SYRUP 2MG/5ML PHARMACARE LIMITED SOUTH AFRICA<br />

VENTIDE INHALER AEROSOL N/A GLAXO WELLCOME UK<br />

LTD<br />

VENTIDE INHALER AEROSOL NA GLAXO WELLCOME UK<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

VENTOLIN AEROSOL N/A GLAXO WELLCOME PAKISTAN<br />

VENTOLIN TABLETS 2MG ALLEN & HANDBURY'S<br />

LIMITED<br />

VENTOLIN EVOHALER AEROSOL 100 MCG/AC GLAXO WELLCOME UK<br />

LTD<br />

VENTOLIN EVOHALER AEROSOL 100UG/AC GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

VENTOLIN INHALER AEROSOL 100MCG ALLEN AND HANBURY<br />

LTD<br />

IRELAND<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

VENTOLIN INHALER AEROSOL INHALER 100MCG PER MDI GLAXO WELLCOME PAKISTAN


EN<br />

740 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

VENTOLIN INHALER AEROSOL 100MCG/AC ALLEN AND HANDBURY<br />

LIMITED<br />

VENTOLIN INHALER SUSPENSION 100MCG GLAXO WELLCOME SA SPAIN<br />

VENTOLIN INJECTION SOLUTION FOR<br />

INJECTION<br />

VENTOLIN INJECTION SOLUTION FOR<br />

INJECTION<br />

VENTOLIN INJECTION<br />

250MCG/5ML<br />

VENTOLIN RESPIRATOR<br />

SOLUTION<br />

VENTOLIN RESPIRATOR<br />

SOLUTION<br />

VENTOLIN SOLN. FOR I.V.<br />

INFUSION<br />

VENTOLIN SOLUTION FOR IV<br />

INFUSION<br />

SOLUTION FOR<br />

INJECTION<br />

500MCG/1ML GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

250MCG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

0.25MG GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

INHALATION SOLUTION 0.5% W/V GLAXO WELLCOME UK<br />

LTD<br />

INHALATION SOLUTION 5MG/ML GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

5MG GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

5MG/1ML GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN<br />

HANDBURYS<br />

VENTOLIN SYRUP ORAL SOLUTION 2MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

VENTOLIN TABLETS TABLETS 2MG GLAXO WELLCOME UK<br />

LIMITED<br />

VENTOLIN TABLETS TABLETS 4MG GLAXO WELLCOME UK<br />

LIMITED T/A ALLEN AND<br />

HANDBURYS<br />

VENTOLIN TABLETS 2MG TABLET 2MG GLAXO WELLCOME UK<br />

LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

VENTOLIN TABLETS 2MG TABLET 2MG GLAXO WELLCOME PAKISTAN<br />

VENTOLIN, 10 FIALE 500MCG FIALE N/A GLAXOSMITHKLINE S.P.A ITALY<br />

VEPESID CAPSULES 100MG CAPSULES 100MG BRISTOL MYERS SQUIBB<br />

HOLDINGS LTD<br />

VEPESID CAPSULES 50MG CAPSULES 50MG BRISTOL MYERS SQUIBB<br />

HOLDINGS LTD<br />

VEPESID INJECTION 5.0ML SOLUTION FOR<br />

INJECTION<br />

VERACOL SOLUTION FOR<br />

INJECTION<br />

VERACOL SOLUTION FOR<br />

INJECTION<br />

100MG/5ML BRISTOL MYERS SQUIBB<br />

HOLDINGS LTD<br />

500MG/VIAL DEMO ABEE GREECE<br />

1G/VIAL DEMO ABEE GREECE<br />

VERACOL POWDER FOR INJECTION 1G/VIAL DEMO ABEE GREECE<br />

VERAPAMIL TABLETS 40MG NORTON HEALTHCARE<br />

LIMITED<br />

VERAPAMIL TABLETS 80MG NORTON HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 741<br />

Trade Name Dosage Form Dose MA Holder Country<br />

VERAPAMIL TABLETS 120MG NORTON HEALTHCARE<br />

LIMITED<br />

VERAPAMIL HCL TABLETS 160MG NORTON HEALTHCARE<br />

LIMITED<br />

VERAPAMIL HYDROCHLORIDE<br />

INJECTION USP<br />

SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

2.5MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

VERAPAMIL TABLETS BP 40MG COATED TABLET 40MG GENERICS (UK) LIMITED UNITED KINGDOM<br />

VERLOST COATED TABLETS 150MG RAFARM GREECE<br />

VERMOX TABLET 500MG JANSSEN PAKISTAN<br />

VERMOX SUSPENSION N/A JANSSEN PAKISTAN<br />

VERMOX TABLET 100MG JANSSEN PAKISTAN<br />

VERMOX SUSPENSION 100MG/5ML JANSSEN PAKISTAN<br />

VERMOX TABLET 500MG JANSSEN PAKISTAN<br />

VERMOX 100MG TABLET 100MG JANSSEN-CILAG N.V. BELGIUM<br />

VERMOX 2% SUSPENSION 20MG/ML JANSSEN-CILAG N.V. BELGIUM<br />

VERMOX 500MG TABLET 500MG JANSSEN-CILAG N.V. BELGIUM<br />

VERORAB VACCINE N/A PASTEUR MERIEUX<br />

SERUMS & VACCINES<br />

LABORATORIES<br />

FRANCE<br />

VERPIR CREAM 5% W/W KLEVA LTD. GREECE<br />

VERRA-MED SOLUTION N/A PERMAMED AG SWITZERLAND<br />

VERRUGON OINTMENT N/A J PICKLES (HARROGATE)<br />

LIMITED T/A J PICKLES<br />

AND SONS<br />

VESSEL SOLUTION FOR<br />

INJECTION<br />

VESSEL SOFT — GELATIN<br />

CAPSULE<br />

600 UNITS ALFA WASSERMANN<br />

S.P.A.<br />

250 UNITS ALFA WASSERMANN<br />

S.P.A.<br />

VESSIFLEX GEL N/A ALFA WASSERMANN<br />

S.P.A.<br />

VEXOL 1% OPHTHALMIC<br />

SUSPENSION<br />

1% W/V ALCON LABORATORIES<br />

INC.<br />

VEXOL 1% EYE DROPS EYE DROPS 1% W/V S.A. ALCON COUVREUR<br />

N.V<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

ITALY<br />

UNITED STATES OF<br />

AMERICA<br />

BELGIUM<br />

VIAGRA FILM-COATED TABLETS 25MG PFIZER LIMITED UNITED KINGDOM<br />

VIAGRA FILM-COATED TABLETS 50MG PFIZER LIMITED UNITED KINGDOM<br />

VIAGRA FILM-COATED TABLETS 100MG PFIZER LIMITED UNITED KINGDOM<br />

VIAREX INHALER 0.05MG/DOSE SCHERING-PLOUGH<br />

NV/SA<br />

VIARTRIL-S CAPSULES 250MG ROTTAPHARM S.R.L. ITALY<br />

BELGIUM<br />

VIBRAMYCIN CAPSULES 100MG PFIZER LIMITED UNITED KINGDOM<br />

VIBRAMYCIN CAPSULE 50MG PFIZER LIMITED UNITED KINGDOM


EN<br />

742 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

VIBRAMYCIN SYRUP 10MG/G PFIZER SA BELGIUM<br />

VIBROCIL DROPS N/A NOVARTIS CONSUMER<br />

HEALTH SA<br />

VIBROCIL GEL N/A NOVARTIS CONSUMER<br />

HEALTH SA<br />

VIBROCIL SPRAY N/A NOVARTIS CONSUMER<br />

HEALTH SA<br />

VI-CAPS CAPSULE N/A DR.GROSSMANN AG<br />

PHARMACA<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

VICEMEX EFFERVESCENT TABLETS 1G CIMEX AG SWITZERLAND<br />

VICKS INHALER INHALATION SOLUTION N/A PROCTER & GAMBLE<br />

(HEALTH & BEAUTY<br />

CARE) LIMITED<br />

VICKS MEDINITE ORAL SOLUTION N/A PROCTER & GAMBLE<br />

(HEALTH & BEAUTY<br />

CARE) LIMITED<br />

VICKS SINEX DECONGESTANT NASAL SPRAY N/A PROCTER & GAMBLE<br />

(HEALTH & BEAUTY<br />

CARE) LIMITED<br />

VICKS VAPORUB NASAL INHALATION<br />

OINTMENT<br />

VICKS VAPOSYRUP FOR CHESTY<br />

COUGHS<br />

VICKS VAPOSYRUP FOR TICKLY<br />

COUGHS<br />

N/A PROCTER & GAMBLE<br />

(HEALTH & BEAUTY<br />

CARE) LIMITED<br />

ORAL SOLUTION 1.333%W/V PROCTER & GAMBLE<br />

(HEALTH & BEAUTY<br />

CARE) LIMITED<br />

ORAL SOLUTION 0.125% W/V PROCTER & GAMBLE<br />

(HEALTH & BEAUTY<br />

CARE) LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

VICKS VAPOUR RUB BALM NA PROCTOR & GAMBLE PAKISTAN<br />

VICOMBIL SYRUP NA BIAL — PRODUTOS<br />

FARMACEUTICOS<br />

VICOMBIL SYRUP SYRUP NA BIAL — ARISTEGUI,<br />

PRODUTOS<br />

FARMACEUTICOS, SA<br />

VIDENE ANTISEPTIC SOLUTION TOPICAL SOLUTION 10% W/W ADAMS HEALTHCARE<br />

LIMITED<br />

VIDENE ANTISEPTIC TINCTURE TOPICAL SOLUTION 10% W/W ADAMS HEALTHCARE<br />

LIMITED<br />

VIDENE SURGICAL SCRUB CUTANEOUS SPONGE 7.5% W/W ADAMS HEALTHCARE<br />

LIMITED<br />

VIDEO-LIGHT EYE DROPS 0.01G/100ML FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

VIDEO-MILL EYE DROPS 0.1% W/V FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

VIDERMINA OVULES 5MG ISTITUTO GANASSINI<br />

S.P.A DI RICERCHE<br />

BIOCHIMICHE<br />

VIDEX TABLETS 100MG BRISTOL-MYERS SQUIBB<br />

EESTI AS<br />

PORTUGAL<br />

PORTUGAL<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

ITALY<br />

ITALY<br />

ESTONIA


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 743<br />

Trade Name Dosage Form Dose MA Holder Country<br />

VIDEX CHEWABLE BUFFERED<br />

TABLETS<br />

100MG BRISTOL-MYERS SQUIBB<br />

COMPANY — USA<br />

VIDISEPT EYE DROPS 50MG/ML DR. GERHARD MANN,<br />

CHEM.-PHARM. FABRIK<br />

GMBH<br />

VIDISIC EYE GEL 2MG/1G DR.GERHARD MANN,<br />

CHEM-PHARM. FABRIK<br />

GMBH<br />

VIGAM LIQUID SOLUTION FOR<br />

INJECTION<br />

VIGAM-S, INTRAVENOUS HUMAN<br />

IGG<br />

5% W/V BIOPRODUCTS<br />

LABORATORY (BPL)<br />

POWDER FOR INJECTION 5%W/V BPI, BIO PRODUCTS<br />

LABORATORY<br />

VIGORAN CAPSULE N/A LABORATOIRE GOLAZ<br />

SA<br />

VIGORAN CAPSULES NA LABORATOIRE GOLAZ<br />

SA<br />

UNITED STATES OF<br />

AMERICA<br />

GERMANY<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

VILONIT EMUGEL 1% W/W KLEVA LTD GREECE<br />

VINBLASTINE INJECTION SOLUTION FOR<br />

INJECTION<br />

VINBLASTINE SULPHATE INJ.<br />

SOLUTION<br />

SOLUTION FOR<br />

INJECTION<br />

VINCRISTINE SOLUTION FOR<br />

INJECTION<br />

10MG/10ML F.H. FAULDING & CO.<br />

LTD. (T/A DAVID BULL<br />

LABS)<br />

1MG/1ML FAULDING<br />

PHARMACEUTICALS PLC<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

1MG/ML TEVA PHARMA BV NETHERLANDS<br />

VINCRISTINE PIERRE FABRE INJECTABLE SOLUTION 1MG/1ML PIERRE FABRE<br />

MEDICAMENT<br />

VINCRISTINE SULFATE SOLUTION FOR<br />

INJECTION<br />

VINCRISTINE SULFATE 2MG/2ML SOLUTION FOR<br />

INJECTION<br />

VINCRISTINE SULFATE SOL. FOR<br />

INJECTION<br />

VINCRISTINE SULPHATE F/INJ<br />

LYOPHILISED<br />

VINCRISTINE SULPHATE FOR<br />

INJECTION BP<br />

VINCRISTINE SULPHATE FOR<br />

INJECTION BP<br />

VINCRISTINE SULPHATE<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

LYOPHILISED CAKE FOR<br />

INJ<br />

2MG/2ML F.H. FAULDING & CO.<br />

LTD. (T/A DAVID BULL<br />

LABS)<br />

1MG/ML PHARMACIA & UPJOHN<br />

(PERTH) PTY LTD.<br />

N/A ABIC LTD.<br />

PHARMACEUTICAL &<br />

CHEMICAL INDUSTRIES<br />

1MG/VIAL M/S SERUM INSTITUTE<br />

OF INDIA LIMITED<br />

POWDER FOR INJECTION 1MG SERUM INSTITUTE OF<br />

INDIA LTD<br />

POWDER FOR INJECTION 2MG SERUM INSTITUTE OF<br />

INDIA LTD<br />

SOLUTION FOR<br />

INJECTION<br />

1MG/ML FAULDING<br />

PHARMACEUTICALS PLC<br />

VIOXX 12.5MG TABLETS TABLET 12.5MG MERCK SHARP & DOHME<br />

LTD.<br />

VIOXX 12.5MG/5ML ORAL<br />

SUSPENSION<br />

ORAL SUSPENSION 12.5MG/5ML MERCK SHARP & DOHME<br />

LTD.<br />

VIOXX 25MG TABLETS TABLET 25MG MERCK SHARP & DOHME<br />

LTD.<br />

VIOXX 25MG/5ML ORAL<br />

SUSPENSION<br />

ORAL SUSPENSION 25MG/5ML MERCK SHARP & DOHME<br />

LTD.<br />

FRANCE<br />

AUSTRALIA<br />

AUSTRALIA<br />

ISRAEL<br />

INDIA<br />

INDIA<br />

INDIA<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

744 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

VIOXXACUTE TABLETS 50 MG MERCK SHARP AND<br />

DOHME LIMITED<br />

VIPROLOX TABLETS 250MG AEGIS LTD CYPRUS<br />

VIRACEPT POWDER FOR ORAL SOL. N/A ROCHE PHARMA<br />

(SCHWEIZ) LTD<br />

VIRACEPT TABLET 250MG ROCHE PHARMA<br />

(SCHWEIZ) LTD.<br />

VIRAMUNE TABLETS 200MG BOEHRINGER INGELHEIM<br />

INTERNATIONAL GMBH<br />

VIRATIN TABLET 40MG RAZA MANUFACTURING<br />

BERHAD<br />

UNITED KINGDOM<br />

SWITZERLAND<br />

SWITZERLAND<br />

GERMANY<br />

MALAYSIA<br />

VIRGAN GEL 0.15% N/A LABORATOIRES THEA FRANCE<br />

VIRORMONE INJECTION SOLUTION FOR<br />

INJECTION<br />

100MG/2ML FERRING<br />

PHARMACEUTICALS<br />

LIMITED<br />

VIROX TABLET 200MG SM PHARMACEUTICALS<br />

SDN. BHD.<br />

UNITED KINGDOM<br />

MALAYSIA<br />

VIRUCID 200 TABLETS 200MG AEGIS LTD. CYPRUS<br />

VIRUCID 400 TABLETS 400MG AEGIS LTD. CYPRUS<br />

VIRUCID 800 TABLETS 800MG AEGIS LTD. CYPRUS<br />

VIRU-MERZ SEROL GEL 0.1/10G MERZ+CO. GMBH & CO. GERMANY<br />

VISCOAT OCULAR VISCOELASTIC<br />

SOLN.<br />

VISIPAQUE SOLUTION FOR<br />

INJECTION<br />

VISIPAQUE SOLUTION FOR<br />

INJECTION<br />

VISIPAQUE SOLUTION FOR<br />

INJECTION<br />

VISIPAQUE SOLUTION FOR<br />

INJECTION<br />

VISIPAQUE SOLUTION FOR<br />

INJECTION<br />

N/A S.A ALCON-COUVREUR<br />

N.V.<br />

BELGIUM<br />

150MG I/ML NYCOMED IMAGING AS NORWAY<br />

270MG I/ML NYCOMED IMAGING AS NORWAY<br />

320MG I/ML NYCOMED IMAGING AS NORWAY<br />

SEE REMARKS AMERSHAM HEALTH AS NORWAY<br />

SEE REMARKS AMERSHAM HEALTH AS NORWAY<br />

VISKALDIX TABLETS N/A NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

VISKALDIX TABLET N/A SANDOZ PAKISTAN<br />

VISKALDIX TABLETS NA NOVARTIS PAKISTAN<br />

VISKALDIX TABLETS NA NOVARTIS PHARMA<br />

GMBH<br />

VISTACARPINE EYE DROPS<br />

2%W/V<br />

VISTACARPINE EYE DROPS 4%<br />

W/V<br />

EYE DROPS 2%W/V MARTINDALE<br />

PHARMACEUTICALS LTD<br />

EYE DROPS 4%W/V MARTINDALE<br />

PHARMACEUTICALS LTD<br />

VISTAMETHASONE DROPS EYE DROPS 0.1%W/V MARTINDALE<br />

PHARMACEUTICALS LTD<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 745<br />

Trade Name Dosage Form Dose MA Holder Country<br />

VISTA-METHASONE N DROPS<br />

F/EYE,EAR AND NOSE<br />

VISTAPHENICOL EYE DROPS 0.5%<br />

BP<br />

VISUDYNE POWDER FOR SOLN. FOR<br />

INJ.<br />

VISUDYNE POWDER F/SOL F/<br />

INFUSION<br />

EYE DROPS N/A MARTINDALE<br />

PHARMACEUTICALS LTD<br />

EYE DROPS 0.5%W/V MARTINDALE<br />

PHARMACEUTICALS LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

15MG CIBA VISION AG SWITZERLAND<br />

15MG NOVARTIS<br />

OPHTHALMICS AG<br />

VIT A N OPHTHALMIC OINTMENT 25000 IU/100G FARMIGEA SPA ITALY<br />

SWITZERLAND<br />

VIT B DENK FILM COATED TABLET NA E.DENK OHG GERMANY<br />

VITAMIN 15 SOLCO COATED TABLETS N/A SOLCO BASLE LTD. SWITZERLAND<br />

VITAMIN A EYE OINTMENT 10.0MG/G NOVARTIS<br />

OPHTHALMICS AG<br />

SWITZERLAND<br />

VITAMIN A 10 000 E/G DISPERSA EYE OINTMENT 10 000IU/G CIBA VISION AG SWITZERLAND<br />

VITAMIN B CO. BPC TABLET N/A SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

VITAMIN B COMPOUND TABLETS N/A REMEDICA LTD CYPRUS<br />

VITAMIN B COMPOUND TABLETS NA PHARMAMED LTD. MALTA<br />

VITAMIN C 100 TABLETS 100MG AEGIS CYPRUS<br />

VITAMIN C 1000MG OBERLIN EFFERVESCENT TABLETS 1000MG LABORATOIRES OBERLIN FRANCE<br />

VITAMIN C 50 TABLETS 50MG AEGIS LTD. CYPRUS<br />

VITAMIN C 500 TABLETS 500MG AEGIS LTD. CYPRUS<br />

UNITED KINGDOM<br />

VITAMIN C EFFERVESCENT TABLET 1000MG KRUGER GMBH & CO. KG GERMANY<br />

VITAMIN C RED ORANGE<br />

EFFERVESCENT<br />

VITAMIN C UPSA EFFERVESCENT<br />

1000MG<br />

TABLET 1000MG KRUGER GMBH & CO. KG GERMANY<br />

EFFERVESCENT TABLETS 1000MG LABORATOIRES UPSA FRANCE<br />

VITAMIN D 5000 CAPSULE 5MG SLOVAKOPHARMA AS<br />

HLOHOVEC<br />

VITAMIN D 800 CAPSULES 0.8MG SLOVAKPHARMA A.S.<br />

HLOHOVEC<br />

VITAMIN K1 SOLUTION FOR<br />

INJECTION<br />

VITAMIN K1 SOLUTION FOR<br />

INJECTION<br />

VITAMIN K1 INJECTION<br />

(PHYTONADIONE INJ USP)<br />

SOLUTION FOR<br />

INJECTION<br />

SLOVAK REPUBLIC<br />

SLOVAK REPUBLIC<br />

2MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

10MG/ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

1MG/0.5ML ABBOTT LABORATORIES UNITED STATES OF<br />

AMERICA<br />

VITAPLUS C PLUS TABLETS N/A ADCOCK INGRAM LTD SOUTH AFRICA<br />

VITARNIN EFFERVESCENT TABLET N/A DR.GROSSMANN AG<br />

PHARMACA<br />

VITATHION EFFERVESCENT<br />

GRANULES<br />

N/A LES LABORATOIRES<br />

SERVIER<br />

SWITZERLAND<br />

FRANCE<br />

VITIRON SUSCAPS N/A MEPHA PHARMA AG SWITZERLAND


EN<br />

746 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

VITLIPID N ADULT EMULSION FOR<br />

INFUSION<br />

VITLIPID N ADULT EMULSION<br />

FOR INJECTION<br />

EMULSION FOR<br />

INFUSION<br />

VITLIPID N INFANT EMULSION EMULSION FOR<br />

INFUSION<br />

NA FRESENIUS KABI LIMITED UNITED KINGDOM<br />

N/A FRESENIUS KABI LIMITED UNITED KINGDOM<br />

NA FRESENIUS KABI LIMITED UNITED KINGDOM<br />

VITREOLENT EYE DROPS N/A CIBA VISION AG SWITZERLAND<br />

VITREOLENT EYE DROPS NA NOVARTIS<br />

OPHTHALMICS AG<br />

VITRIMIX INTRAVENOUS INFUSION N/A PHARMACIA & UPJOHN<br />

SVERIGE AB<br />

VITRITE/SEVEN SEAS/MINADEX<br />

MULTIVIT. SYR<br />

SWITZERLAND<br />

SWEDEN<br />

ORAL SOLUTION N/A SEVEN SEAS LIMITED UNITED KINGDOM<br />

VIVALAN COATED TABLETS 50MG ZENECA LIMITED UNITED KINGDOM<br />

VIVIDRIN ANTI-ALLERGIC<br />

EYEDROPS<br />

SOLUTION 20MG/ML DR. GERHARD MANN,<br />

CHEM.-PHARM. FABRIK<br />

GMBH<br />

VIVIOPTAL CAPSULES NA DR.GERHARD MANN,<br />

CHEM.PHARM. FABRIK<br />

GMBH<br />

VIVOTIF BERNA CAPS FOR ORAL<br />

IMMUNISAT.<br />

N/A SWISS SERUM AND<br />

VACCINE INSTITUTE<br />

VIVOTIF BERNA CAPSULE N/A ISTITUTO<br />

SIEROTERAPICO BERNA<br />

S.R.L.<br />

VOLMAX CONTROLLED RELEASE<br />

TABLET<br />

VOLMAX CONTROLLED RELEASE<br />

TABLET<br />

VOLMAX 4MG MODIFIED RELEASE<br />

TABLETS<br />

VOLMAX 8MG MODIFIED RELEASE<br />

TABLETS<br />

VOLMAX TABLETS 4MG MODIFIED RELEASE<br />

TABLET<br />

VOLMAX TABLETS 8MG MODIFIED RELEASE<br />

TABLET<br />

4MG GLAXOSMITHKLINE<br />

GMBH & CO KG<br />

GERMANY<br />

GERMANY<br />

SWITZERLAND<br />

ITALY<br />

GERMANY<br />

4MG GLAXO ALLEN S.P.A. ITALY<br />

4MG GLAXO WELLCOME UK<br />

LIMITED<br />

8MG GLAXO WELLCOME UK<br />

LIMITED<br />

4MG GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

8MG GLAXO WELLCOME UK<br />

LTD T/A ALLEN &<br />

HANBURYS<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

VOLTAMICIN EYE DROPS N/A CIBA VISION AG SWITZERLAND<br />

VOLTAMICIN EYE DROPS NA NOVARTIS<br />

OPHTHALMICS AG<br />

VOLTAREN EMUGEL 10MG/G NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

VOLTAREN ENTERIC COATED<br />

TABLETS<br />

VOLTAREN ENTERIC COATED<br />

TABLETS<br />

25MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

50MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 747<br />

Trade Name Dosage Form Dose MA Holder Country<br />

VOLTAREN SUPPOSITORIES 12.5MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

VOLTAREN SUPPOSITORIES 50MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

VOLTAREN SUPPOSITORIES 100MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

VOLTAREN TABLET 25MG GEIGY PAKISTAN<br />

VOLTAREN TABLET 50MG GEIGY PAKISTAN<br />

VOLTAREN EMULGEL N/A GEIGY PAKISTAN<br />

VOLTAREN E/C TABLETS 50MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

VOLTAREN DISPERSABLE TABLETS 50MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

VOLTAREN AMPOULES 75MG NOVARTIS NV —<br />

BELGIUM<br />

VOLTAREN SUPPOSITORY 100MG NOVARTIS PHARMA<br />

GMBH<br />

VOLTAREN SUPPOSITORY 50MG NOVARTIS PHARMA<br />

GMBH<br />

VOLTAREN FILM COATED TABLETS 25MG NOVARTIS PHARMA<br />

GMBH<br />

VOLTAREN FILM COATED TABLETS 50MG NOVARTIS PHARMA<br />

GMBH<br />

VOLTAREN GASTRO-RESISTANT<br />

TABLETS<br />

SWITZERLAND<br />

SWITZERLAND<br />

BELGIUM<br />

GERMANY<br />

GERMANY<br />

AUSTRIA<br />

AUSTRIA<br />

50MG NOVARTIS FARMA SPA ITALY<br />

VOLTAREN DISPERSABLE TABLETS 50MG NOVARTIS (HELLAS)<br />

SACL<br />

VOLTAREN 1% EMULGEL 1G/100G NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

VOLTAREN 1.5% ORAL DROPS (SUSP.) 15MG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

VOLTAREN DISPERS TABLETS 50MG NOVARTIS PHARMA<br />

GMBH<br />

VOLTAREN OPHTHA EYE DROPS 1MG/ML NOVARTIS PHARMA<br />

(SCHWEIZ) AG<br />

VOLTAREN OPHTHA EYE DROPS 1.00MG/ML NOVARTIS<br />

OPHTHALMICS AG<br />

VOLTAREN RETARD S.R. FILM COATED<br />

TABLETS<br />

100MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

VOLTAREN RETARD FILM COATED TABLETS 75MG NOVARTIS PHARMA<br />

SCHWIEZ<br />

GREECE<br />

SWITZERLAND<br />

SWITZERLAND<br />

AUSTRIA<br />

SWITZERLAND<br />

SWITZERLAND<br />

SWITZERLAND<br />

VOLTAREN RETARD FILM COATED TABLET 100MG NOVARTIS GMBH AUSTRIA<br />

VOLTAREN RETARD FILM COATED TABLETS 75MG NOVARTIS PHARMA<br />

GMBH<br />

VOLTAREN SR SLOW RELEASE TABLETS 75MG NOVARTIS FARMA SPA ITALY<br />

UNITED KINGDOM<br />

AUSTRIA


EN<br />

748 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

VOLTAROL SUPPOSITORIES SUPPOSITORIES 12.5 MG NOVARTIS<br />

PHARMACEUTICALS UK<br />

LIMITED<br />

IRELAND<br />

VOLTRAL TABLETS 50MG NOVARTIS PAKISTAN<br />

VOLTRAL TABLET 25MG NOVARTIS PAKISTAN<br />

VOLTRAL EMUGEL 1G/100G NOVARTIS PAKISTAN<br />

VOMILUX TABLETS 10MG ATCO LABORATORIES<br />

(PVT) LTD<br />

VOMILUX SUSPENSION 1MG/1ML ATCO LABORATORIES<br />

(PVT) LTD<br />

PAKISTAN<br />

PAKISTAN<br />

VOSTAR 100 MG SUPPOSITORY SUPPOSITORY 100 MG DELTA HF ICELAND<br />

VOSTAR 25 MG<br />

GASTRO-RESISTANT TABLETS<br />

VOSTAR 50 MG<br />

GASTRO-RESISTANT TABLETS<br />

TABLETS 25MG DELTA HF ICELAND<br />

TABLET 50 MG DELTA HF ICELAND<br />

VOSTAR 50 MG SUPPOSITORY SUPPOSITORY 50 MG DELTA HF ICELAND<br />

VOSTAR-R 100MG PROLONGED<br />

RELEASE<br />

VOSTAR-R 75 MG PROLONGED<br />

RELEASE<br />

TABLET 100 MG DELTA HF ICELAND<br />

TABLET 75MG DELTA HF ICELAND<br />

V-PLEX TABLET TABLET N/A THE ACME LABRATORIES<br />

LTD — BANGLADESH<br />

WARFARIN TABLETS 1MG NORTON<br />

PHARMACEUTICALS<br />

LIMITED<br />

WARFARIN TABLETS 3MG NORTON<br />

PHARMACEUTICALS<br />

LIMITED<br />

WARFARIN TABLETS 5MG NORTON HEALTHCARE<br />

LIMITED<br />

BANGLADESH<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

WARFARIN 1MG TABLETS TABLET 1MG FORLEY GENERICS LTD UNITED KINGDOM<br />

WARFARIN 3MG TABLETS TABLETS 3MG FORLEY GENERICS LTD UNITED KINGDOM<br />

WARFARIN 5MG TABLETS TABLETS 5MG FORLEY GENERICS<br />

LIMITED<br />

WARIACTIV SPRAY 88G/100ML WALTER RITTER GMBH +<br />

CO<br />

WARI-FIGURAN-M SUGAR COATED TABLET N/A ARTESAN PHARMA<br />

GMBH & CO. KG<br />

WARI-PROCOMIL S/C TABLETS N/A WALTER RITTER GMBH +<br />

CO.<br />

WARTEX OINTMENT N/A J PICKLES (HARROGATE)<br />

LIMITED<br />

WARTICON TOPICAL SOLUTION 0.5%W/W STIEFEL LABORATORIES<br />

UK LIMITED<br />

WARTICON CREAM CREAM 0.15%W/W STIEFEL LABORATORIES<br />

UK LIMITED<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 749<br />

Trade Name Dosage Form Dose MA Holder Country<br />

WARTICON FEM TOPICAL SOLUTION 0.5%W/V STIEFEL LABORATORIES<br />

(UK) LIMITED<br />

WASP-EZE SPRAY N/A MUNDIPHARMA<br />

PHARMACEUTICALS LTD<br />

WATER FOR INJECTION<br />

AGUETTANT<br />

WATER FOR INJECTION PE SOLUTION FOR<br />

INJECTION<br />

WATER FOR INJECTION/DEMO SOLUTION FOR<br />

INJECTION<br />

WATER FOR INJECTION/DEMO SOLUTION FOR<br />

INJECTION<br />

WATER FOR INJECTIONS SOLVENT FOR<br />

PARENTERAL US<br />

WATER FOR INJECTIONS BP SOLUTION FOR<br />

INJECTION<br />

WATER FOR INJECTIONS BP SOLUTION FOR<br />

INJECTION<br />

WATER FOR INJECTION NO ACTIVE INGR. LABORATOIRE<br />

AGUETTANT<br />

UNITED KINGDOM<br />

CYPRUS<br />

FRANCE<br />

NO ACTIVE INGR. POLPHARMA S.A. POLAND<br />

NO ACTIVE ING. DEMO ABEE GREECE<br />

NO ACTIVE ING. DEMO ABEE GREECE<br />

NA PHARMAMED<br />

PARENTERALS LTD.<br />

MALTA<br />

NO ACTIVE ING. B.BRAUN MELSUNGEN GERMANY<br />

NO ACTIVE ING. B.BRAUN MELSUNGEN<br />

AG<br />

WATERLEX TABLETS COATED TABLET N/A CATHAY OF<br />

BOURNEMOUTH LTD<br />

GERMANY<br />

UNITED KINGDOM<br />

WAXSOL SOLUTION 0.5%W/V NORGINE LIMITED UNITED KINGDOM<br />

WAXSOL EAR DROPS 0.5% W/V NORGINE LIMITED UNITED KINGDOM<br />

WAXWANE EAR DROPS EAR DROPS N/A THORNTON & ROSS LTD UNITED KINGDOM<br />

WELLBUTRIN SR SUSTAINED RELEASE<br />

TABLET<br />

WELLFERON INTERFERON<br />

ALFA-NI (1NS) 10MU<br />

WELLFERON INTERFERON<br />

ALFA-NI (1NS) 3MU<br />

SOLUTION FOR<br />

INJECTION<br />

SOLUTION FOR<br />

INJECTION<br />

150MG GLAXO WELLCOME INC. CANADA<br />

10MU/ML THE WELLCOME<br />

FOUNDATION LTD.<br />

3MU/1ML THE WELLCOME<br />

FOUNDATION LTD.<br />

WHITE SOFT PARAFFIN BP OINTMENT NA BELL SONS &<br />

CO(DRUGGISTS) LIMITED<br />

WHITFIELD'S OINTMENT OINTMENT N/A BELL SONS & CO<br />

(DRUGGISTS) LIMITED<br />

WILPRAFEN SUSPENSION 3G/100ML YAMANOUCHI PHARMA<br />

GMBH<br />

WILPRAFEN FILM-COATED TABLETS 500MG YAMANOUCHI PHARMA<br />

GMBH<br />

WILPRAFEN FORTE SUSPENSION 6G/100ML YAMANOUCHI PHARMA<br />

GMBH<br />

WINRHO SDF — KIT PWS<br />

(1500IU)<br />

POWDER FOR INJECTION N/A CANGENE<br />

CORPORATION<br />

WINRHO SDF-KIT PWS 1500IU POWDER FOR REC. 1500IU/2.5ML CANGENE<br />

CORPORATION<br />

WINRHO SDF-KIT PWS(600IU) POWDER FOR REC. 600IU/2.5ML CANGENE<br />

CORPORATION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

GERMANY<br />

GERMANY<br />

GERMANY<br />

CANADA<br />

CANADA<br />

CANADA<br />

WITCH DOCTOR GEL GEL 81.539%W/W E C DE WITT & CO LTD UNITED KINGDOM<br />

WITCH DOCTOR STIK SOLID STICK 15.88%W/W E C DE WITT & CO LTD UNITED KINGDOM


EN<br />

750 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

WITCH HAZEL DISTILLED BPC<br />

1973<br />

WOBE-MUGOS E ENTERIC COATED<br />

TABLET<br />

WOBENZYM N SUG. COAT. GAST-RES.<br />

TABL<br />

WOODWARD'S GRIPE WATER —<br />

ALC. AND SUGAR FR<br />

WOODWARD'S GRIPE WATER —<br />

ALCOHOL FREE<br />

TOPICAL SOLUTION 100%V/V LCM LTD UNITED KINGDOM<br />

N/A MUCOS PHARMA GMBH<br />

& CO.<br />

N/A MUCOS PHARMA GMBH<br />

& CO.<br />

GERMANY<br />

GERMANY<br />

ORAL SOLUTION N/A SETON PRODUCTS LTD. UNITED KINGDOM<br />

ORAL SOLUTION N/A SETON PRODUCTS LTD. UNITED KINGDOM<br />

XALACOM EYE DROPS NA PHARMACIA NV/SA BELGIUM<br />

XALATAN EYE DROPS 50MCG/ML PHARMACIA & UPJOHN<br />

AB<br />

XALATAN EYE DROPS 0.005% W/V PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

BELGIUM<br />

BELGIUM<br />

XANAX TABLETS 0.25MG PHARMACIA N.V./S.A. BELGIUM<br />

XANAX TABLETS 0.5MG PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

XANAX TABLETS 1MG PHARMACIA & UPJOHN<br />

N.V. / S.A.<br />

XANOMEL 150 FILM-COATED TABLETS 150MG CLONMEL HEALTHCARE<br />

LIMITED<br />

XATRAL LP 10MG PROLONGED RELEASE<br />

TABLET<br />

10MG LABORATOIRES<br />

SYNTHELABO<br />

XATRAL SR 5MG SR FILM-COATED TABLET 5MG LABORATOIRES<br />

SYNTHELABO<br />

XELODA 150MG FILM COATED TABLETS 150MG ROCHE PHARMA<br />

SCHWEIZ LTD.<br />

XELODA 500MG FILM COATED TABLETS 500MG ROCHE PHARMA<br />

SCHWEIZ LTD.<br />

XENAR TABLETS 250MG ALFA WASSERMANN<br />

S.P.A.<br />

XENAR CONTROLLED RELEASE<br />

TABLET<br />

750MG ALFA WASSERMANN<br />

S.P.A.<br />

XENICAL CAPSULES 120MG ROCHE PHARMA<br />

(SCHWEIZ) AG<br />

XEPIN CREAM 5% W / W BIOGLAN<br />

LABORATORIES LTD<br />

XIGRIS POWDER FOR SOLUTION<br />

FOR INFUSION<br />

2MG/ML ELI LILLY NEDERLAND<br />

BV<br />

XITHRONE CAPSULES 250MG AMOUN<br />

PHARMACEUTICALS CO<br />

SAE<br />

XYLOCAIN SOLUTION FOR<br />

INJECTION<br />

XYLOCAIN SOLUTION FOR<br />

INJECTION<br />

BELGIUM<br />

BELGIUM<br />

IRELAND<br />

FRANCE<br />

FRANCE<br />

SWITZERLAND<br />

SWITZERLAND<br />

ITALY<br />

ITALY<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

EUROPEAN COMMUNITY<br />

EGYPT<br />

10MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

20MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

XYLOCAIN SPRAY SOLUTION 10MG/DOSE ASTRA LAKEMEDEL AB SWEDEN


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 751<br />

Trade Name Dosage Form Dose MA Holder Country<br />

XYLOCAIN GEL 2% W/W ASTRA LAKEMEDEL AB SWEDEN<br />

XYLOCAIN OINTMENT 5% W/W ASTRA LAKEMEDEL AB SWEDEN<br />

XYLOCAIN SOLUTION FOR<br />

INJECTION<br />

XYLOCAIN SOLUTION FOR<br />

INJECTION<br />

XYLOCAIN ADRENALIN SOLUTION FOR<br />

INJECTIONS<br />

XYLOCAIN ADRENALIN SOLUTION FOR<br />

INJECTION<br />

XYLOCAIN ADRENALIN SOLUTION FOR<br />

INJECTION<br />

XYLOCAIN ADRENALIN SOLUTION FOR<br />

INJECTION<br />

XYLOCARD SOLUTION FOR<br />

INJECTION<br />

XYLOCARD CONCENTRATE FOR<br />

INFUSION<br />

XYLONOR SOLUTION FOR DENTAL<br />

USE<br />

10MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

20MG/ML ASTRA LAKEMEDEL AB SWEDEN<br />

N/A ASTRA LAKEMEDEL AB SWEDEN<br />

N/A ASTRA LAKEMEDEL SWEDEN<br />

N/A ASTRA LAKEMEDEL AB SWEDEN<br />

20MG ASTRAZENECA SVERIGE<br />

AB<br />

SWEDEN<br />

20MG/ML HASSLE LAKEMEDEL AB SWEDEN<br />

200MG/ML HASSLE LAKEMEDEL AB SWEDEN<br />

N/A LABORATOIRES<br />

SEPTODONT<br />

XYLONOR GINGIVAL GEL N/A LABORATOIRES<br />

SEPTODONT<br />

FRANCE<br />

FRANCE<br />

XYLOPROCT OINTMENT N/A TIKA LAKEMEDEL AB SWEDEN<br />

XYLOPROCT SUPPOSITORIES N/A TIKA LAKEMEDEL AB SWEDEN<br />

XYZAL FILM-COATED TABLETS 5MG UCB-PHARMA AG SWITZERLAND<br />

YASMIN FILM-COATED TABLETS N/A SCHERING AG GERMANY<br />

YEAST 300MG BPC TABLET 300MG SUSSEX<br />

PHARMACEUTICAL<br />

LIMITED<br />

YESAN EYE DROPS SOLUTION 0.5% W/V RAFARM GREECE<br />

YUTOPAR TABLET 10MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

YUTOPAR INJECTION FLUID 10MG/ML SOLVAY<br />

PHARMACEUTICALS B.V.<br />

YUTOPAR SR CAPSULE 40MG SOLVAY<br />

PHARMACEUTICALS B.V.<br />

ZACIN CREAM 0.025% CREAM 0.025% W/W BIOGLAN<br />

LABORATORIES LTD<br />

ZACLOFEN TABLET 10MG ALFARES<br />

PHARMACEUTICALS<br />

ZACLOFEN TABLETS TABLETS 10 MG ALFARES<br />

PHARMACEUTICALS<br />

ZACTIN CAPSULE 20MG ALPHAPHARM PTY<br />

LIMITED<br />

ZACTOLINE TABLETS 5MG BIOGLAN<br />

LABORATORIES LTD<br />

UNITED KINGDOM<br />

NETHERLANDS<br />

NETHERLANDS<br />

NETHERLANDS<br />

UNITED KINGDOM<br />

SYRIA<br />

SYRIA<br />

AUSTRALIA<br />

IRELAND


EN<br />

752 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ZACTOLINE TABLETS 10MG BIOGLAN<br />

LABORATORIES LTD<br />

ZADAXIN SOLUTION FOR<br />

INJECTIONS<br />

1.6MG/ML SCICLONE<br />

PHARMACEUTICALS<br />

ITALY S.R.L.<br />

IRELAND<br />

ZADITEN EYE DROPS 0.25MG/ML CIBA VISION AG SWITZERLAND<br />

ZADITEN ORAL SOLUTION 1MG/ML NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

ZADITEN TABLETS 1MG NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

ZADITEN HARD CAPSULES 1MG NOVARTIS FARMA —<br />

PRODUTOS<br />

FARMACEUTICOS S.A.<br />

ZADITEN 0.025% OPHTHA EYE DROPS NA NOVARTIS<br />

OPHTHALMICS AG<br />

ZADITEN TABLETS 1MG TABLETS 1MG NOVARTIS PHARM. UK.<br />

LTD. T/A SANDOZ<br />

PHARM.<br />

ITALY<br />

SWITZERLAND<br />

SWITZERLAND<br />

PORTUGAL<br />

SWITZERLAND<br />

UNITED KINGDOM<br />

ZADORIN SUSCAPS 100MG MEPHA PHARMA AG SWITZERLAND<br />

ZAMADOL CAPSULES 50MG ASTA MEDICA LTD UNITED KINGDOM<br />

ZAMADOL INJECTION SOLUTION FOR<br />

INJECTION<br />

ZAMADOL SR CAPSULES 100MG MODIFIED RELEASE<br />

CAPSULE<br />

ZAMADOL SR CAPSULES 150MG MDIFIED RELEASE<br />

CAPSULE<br />

ZAMADOL SR CAPSULES 200MG MODIFIED RELEASE<br />

CAPSULE<br />

ZAMADOL SR CAPSULES 50MG MODIFIED RELEASE<br />

CAPSULE<br />

50MG/ML ASTA MEDICA LTD UNITED KINGDOM<br />

100MG ASTA MEDICA LTD UNITED KINGDOM<br />

150MG ASTA MEDICA LTD UNITED KINGDOM<br />

200MG ASTA MEDICA LTD. UNITED KINGDOM<br />

50MG ASTA MEDICA LIMITED UNITED KINGDOM<br />

ZANTAC TABLET 150MG GLAXO WELLCOME PAKISTAN<br />

ZANTAC FILM-COATED TABLETS 75 MG DUNCAN<br />

FARMACEUTICA S. A<br />

ZANTAC EFFERVESCENT TABLETS 150MG LABORATOIRES<br />

GLAXOSMITHKLINE<br />

ZANTAC EFFERVESCENT TABLETS 300MG LABORATOIRES<br />

GLAXOSMITHKLINE<br />

ZANTAC TABLETS 300MG GLAXO LABORATORIES<br />

LIMITED<br />

ZANTAC TABLETS 150MG GLAXO LABORATORIES<br />

LIMITED<br />

ZANTAC SYRUP NA GLAXO WELLCOME UK<br />

LIMITED<br />

ZANTAC 150 FILM-COATED<br />

TABLET<br />

SPAIN<br />

FRANCE<br />

FRANCE<br />

TABLET 150MG GLAXO WELLCOME S.A. SPAIN<br />

ZANTAC 300MG COATED TABLETS 300MG GLAXO WELLCOME UK<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 753<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ZANTAC 75 RELIEF TABLETS 75MG GLAXO WELLCOME UK<br />

LIMITED<br />

ZANTAC 75MG TABLETS 75MG GLAXO WELLCOME UK<br />

LIMITED<br />

ZANTAC EFFERVESCENT TABLETS EFFERVESCENT TABLETS 150MG GLAXO WELLCOME UK<br />

LIMITED<br />

ZANTAC INJECTION SOLUTION FOR<br />

INJECTION<br />

ZANTAC INJECTION SOLUTION FOR<br />

INJECTION<br />

ZANTAC INJECTION (50MG/2ML) SOLUTION FOR<br />

INJECTION<br />

50MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

50MG/2ML GLAXO WELLCOME UK<br />

LIMITED<br />

50MG/2ML GLAXO WELLCOME UK<br />

LTD T/A GLAXO LABS<br />

ZANTAC SYRUP ORAL SOLUTION 150MG GLAXO WELLCOME UK<br />

LTD<br />

ZANTAC SYRUP ORAL SOLUTION 150MG/10ML GLAXO WELLCOME UK<br />

LIMITED<br />

ZANTAC SYRUP ORAL SOLUTION 150MG/DOSE GLAXO WELLCOME UK<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ZANTAC TABLETS TABLET 150MG GLAXO WELLCOME PAKISTAN<br />

ZANTAC TABLETS COATED TABLETS 150MG GLAXO WELLCOME UK<br />

LIMITED<br />

ZANTAC TABLETS 150MG COATED TABLET 150MG GLAXO WELLCOME UK<br />

LTD<br />

ZANTAC TABLETS 300MG COATED TABLET 300MG GLAXO WELLCOME UK<br />

LTD<br />

ZANTAC TABLETS 75MG TABLET 75MG GLAXO WELLCOME UK<br />

LTD<br />

ZARONTIN CAPSULES 250MG CAPSULE 250MG WARNER LAMBERT (UK)<br />

LIMITED<br />

ZAVEDOS POWDER FOR INJECTION 5MG/VIAL PHARMACIA & UPJOHN<br />

S.P.A.<br />

ZAVEDOS POWDER FOR INJECTION 10MG/VIAL PHARMACIA & UPJOHN<br />

S.P.A<br />

ZAVEDOS CAPSULES 5MG PHARMACIA & UPJOHN<br />

S.P.A.<br />

ZAVEDOS CAPSULES 10MG PHARMACIA & UPJOHN<br />

S.P.A.<br />

ZAVEDOS CAPSULE 25MG PHARMACIA & UPJOHN<br />

S.P.A.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ZAVERA TABLET 240MG ZAFA PAKISTAN<br />

ZELMAC TABLETS 6MG NOVARTIS PHARMA<br />

SCHWEIZ AB<br />

ZELOXIM TABLET 7.5MG BILIM ILAC SANAYIIA VE<br />

ATICARET AS<br />

ZELOXIM 15MG FORT TABLET 15MG BILIM ILAC SANANYII VE<br />

TICARET AS<br />

ZENALB (TM) 4.5 HUMAN<br />

ALBUMIN 4.5%<br />

SOLUTION FOR<br />

INJECTION<br />

4.5% W/V BPL, BIO PRODUCTS<br />

LABORATORY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

ITALY<br />

SWITZERLAND<br />

TURKEY<br />

TURKEY<br />

UNITED KINGDOM


EN<br />

754 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ZENALB-20, 20% HUMAN<br />

ALBUMIN SOLUTION<br />

STERILE LIQ. FOR<br />

INFUSION<br />

N/A BPL, BIO PRODUCTS<br />

LABORATORY<br />

ZENTEL 0.4G/10ML ORAL SUSPENSION 0.4G/10ML LABORATOIRES<br />

SMITHKLINE BEECHAM<br />

ZENTEL 400MG FILM-COATED TABLET 400MG LABORATOIRES<br />

SMITHKLINE BEECHAM<br />

UNITED KINGDOM<br />

FRANCE<br />

FRANCE<br />

ZEPHOLIN TABLETS 10MG GENEPHARM S.A. GREECE<br />

ZERIT CAPSULES 30MG BRISTOL-MYERS SQUIBB<br />

COMPANY<br />

ZERIT CAPSULES 40MG BRISTOL-MYERS SQUIBB<br />

PHARMA EEIG<br />

UNITED STATES OF<br />

AMERICA<br />

EUROPEAN COMMUNITY<br />

ZESTORETIC 20 TABLET N/A ZENECA LIMITED UNITED KINGDOM<br />

ZESTORETIC-20 TABLETS N/A ZENECA LIMITED UNITED KINGDOM<br />

ZESTRIL TABLET 5MG ZENECA LIMITED UNITED KINGDOM<br />

ZESTRIL TABLET 10MG ZENECA LIMITED UNITED KINGDOM<br />

ZESTRIL TABLETS 20MG ZENECA LIMITED UNITED KINGDOM<br />

ZESTRIL 5MG TABLETS 5MG ICI PAKISTAN<br />

ZESTRIL TABLETS 10MG TABLET 10MG ZENECA LIMITED UNITED KINGDOM<br />

ZESTRIL TABLETS 20MG TABLET 20MG ZENECA LIMITED UNITED KINGDOM<br />

ZESTRIL TABLETS 5MG TABLET 5MG ZENECA LIMITED UNITED KINGDOM<br />

ZETAGAL POWDER FOR INJECTION 750MG/VIAL ELPEN S.A. GREECE<br />

ZETAGAL POWDER FOR INJECTION 250MG/VIAL ELPEN S.A GREECE<br />

ZETALAX SUPPOSITORIES 2.25G ZETA FARMACEUTICI<br />

S.P.A.<br />

ZETRIZIN FILM COATED TABLET 10MG ALFARES<br />

PHARMACEUTICALS<br />

ZETRIZIN SYRUP 5MG/5ML ALFARES<br />

PHARMACEUTICALS<br />

ZETRIZIN FILM — COATED<br />

TABLETS<br />

FILM-COATED TABLETS 10 MG ALFARES<br />

PHARMACEUTICALS<br />

ZETRIZIN SYRUP SYRUP 5MG ALFARES<br />

PHARMACEUTICALS<br />

ZIAGEN FILM COATED TABLETS 300MG GLAXO GROUP LTD. UNITED KINGDOM<br />

ZIAGEN ORAL SOLUTION 20MG/ML GLAXO GROUP LTD. UNITED KINGDOM<br />

ZIDEPRIL TABLETS 50MG/25MG MINERVA<br />

PHARMACEUTICAL S.A.<br />

ZIDOVAL VAGINAL GEL 0.75% W/W 3M HEALTH CARE<br />

LIMITED<br />

ZIDOVIR 100 CAPSULES 100MG CIPLA LTD INDIA<br />

ZIDOVUDINE COMBINO PHARM CAPSULES 100MG COMBINO PHARM SL SPAIN<br />

ITALY<br />

SYRIA<br />

SYRIA<br />

SYRIA<br />

SYRIA<br />

GREECE<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 755<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ZILISTEN DRY POWDER F/<br />

INJECTION<br />

750MG/VIAL DEMO ABEE GREECE<br />

ZILISTEN VIAL DRY POWDER 1500 MG DEMO S.A. GREECE<br />

ZIMOR CAPSULES 20MG LABORATORIOS RUBIO<br />

S.A<br />

ZINACEF POWDER FOR INJECTION 750MG GLAXO OPERATIONS UK<br />

LIMITED<br />

ZINACEF POWDER FOR INJECTION 250MG GLAXO OPERATIONS UK<br />

LIMITED<br />

ZINACEF ‘250’ IM FLAC 250MG +<br />

1FIALA 1ML<br />

ZINACEF ‘750’ IM FLAC 750MG +<br />

F3ML<br />

POWDER AND SOL FOR<br />

INJ.<br />

POWDER AND SOL FOR<br />

INJ.<br />

SPAIN<br />

N/A GLAXOSMITHKLINE S.P.A ITALY<br />

N/A GLAXOSMITHKLINE S.P.A ITALY<br />

ZINACEF INJECTION 1.5G POWDER FOR INJECTION 1.5G GLAXO OPERATIONS UK<br />

LTD<br />

ZINACEF INJECTION 250MG POWDER FOR INJECTION 250MG GLAXO OPERATIONS UK<br />

LTD<br />

ZINACEF INJECTION 750MG POWDER FOR INJECTION 750MG GLAXO OPERATIONS UK<br />

LTD<br />

ZINC AND CASTOR OIL<br />

OINTMENT BP<br />

ZINC AND CASTOR OIL<br />

OINTMENT BP<br />

OINTMENT 7.5% W/W ADAMS HEALTHCARE<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

OINTMENT N/A LCM LTD UNITED KINGDOM<br />

ZINCABAND PASTE BANDAGE PAD 15% W/W SETON HEALTHCARE<br />

GROUP PLC<br />

ZINCAST OINTMENT N/A BELL, SONS & CO<br />

(DRUGGISTS) LIMITED<br />

ZINCAST BABY CREAM OINTMENT N/A BELL SONS & CO<br />

(DRUGGISTS) LIMITED<br />

ZINCOMETIL EYE DROPS N/A FARMILA FARMACEUTICI<br />

MILANO S.P.A.<br />

ZINDOLIN TABLETS 250MG REMEDICA LTD CYPRUS<br />

ZINELI EYE DROPS SOLUTION 2% W/V RAFARM GREECE<br />

ZINERYT LOTION N/A YAMANOUCHI PHARMA<br />

B.V.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ITALY<br />

NETHERLANDS<br />

ZINNAT SUSPENSION N/A GLAXO WELLCOME PAKISTAN<br />

ZINNAT TABLET 250MG GLAXO WELLCOME PAKISTAN<br />

ZINNAT COATED TABLETS 500MG GLAXO WELLCOME UK<br />

LIMITED<br />

ZINNAT TABLETS 500MG GLAXO LABORATORIES<br />

LIMITED<br />

ZINNAT ORAL SUSPENSION 250MG/5ML GLAXO LABORATORIES<br />

LIMITED<br />

ZINNAT SUSPENSION GRANULES F/ORAL SUSP. 250MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

756 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ZINNAT SUSPENSION GRANULES F/ORAL SOLN 125MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

ZINNAT SUSPENSION GRANULES FOR ORAL<br />

SOLN<br />

ZINNAT SUSPENSION 125MG/5ML GRANULES FOR ORAL<br />

SOLN.<br />

ZINNAT SUSPENSION 250MG/5ML GRANULES FOR ORAL<br />

SUSP.<br />

125MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

125MG/5ML GLAXO WELLCOME UK<br />

LTD<br />

250MG/5ML GLAXO WELLCOME UK<br />

LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ZINNAT TABLETS TABLETS 250MG GLAXOWELLCOME PAKISTAN<br />

ZINNAT TABLETS COATED TABLETS 125MG GLAXO WELLCOME UK<br />

LIMITED<br />

ZINNAT TABLETS COATED TABLETS 250MG GLAXO WELLCOME UK<br />

LIMITED<br />

ZINNAT TABLETS 125MG COATED TABLET 125MG GLAXO WELLCOME UK<br />

LTD<br />

ZINNAT TABLETS 250MG COATED TABLET 250MG GLAXO WELLCOME UK<br />

LTD<br />

ZITAZONIUM 10MG TABLETS 10MG EGIS PHARMACEUTICALS<br />

LTD.<br />

ZITAZONIUM 20MG TABLETS 20MG EGIS PHARMACEUTICALS<br />

LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

HUNGARY<br />

HUNGARY<br />

ZITHROMAX CAPSULE 250MG PFIZER LIMITED UNITED KINGDOM<br />

ZITHROMAX POWDER FOR ORAL<br />

SUSPENSIO<br />

N/A PFIZER LIMITED UNITED KINGDOM<br />

ZITHROMAX TABLETS 500MG COATED TABLETS 500MG PFIZER LIMITED UNITED KINGDOM<br />

ZIVIR CAPSULE 100MG OKASA PHARMA PVT<br />

LTD- INDIA<br />

ZOCOR TABLET 10MG M.S.D. PAKISTAN<br />

ZOCOR TABLETS 40MG MERCK SHARP & DOHME<br />

B.V.<br />

ZOCOR 10MG TABLET 10MG MERCK SHARP & DOHME<br />

B.V.<br />

INDIA<br />

NETHERLANDS<br />

NETHERLANDS<br />

ZOCOR 10MG TABLETS 10MG MERCH SHARP & DOHME PAKISTAN<br />

ZOCOR 20MG TABLET 20MG MERCK SHARP & DOHME NETHERLANDS<br />

ZOCOR 20MG TABLETS 20MG MERCH SHARP & DOHME PAKISTAN<br />

ZOFRAN INJECTION SOLUTION FOR<br />

INJECTION<br />

ZOFRAN INJECTION 2MG/ML SOLUTION FOR<br />

INJECTION<br />

2MG/ML GLAXO OPERATIONS UK<br />

LIMITED<br />

2MG/ML GLAXO OPERATIONS UK<br />

LTD<br />

ZOFRAN SYRUP SYRUP 0.1% W/V GLAXO WELLCOME UK<br />

LTD<br />

ZOFRAN SYRUP ORAL LIQUID 4MG/5ML GLAXO WELLCOME UK<br />

LTD<br />

ZOFRAN SYRUP ORAL LIQUID 4MG/5ML GLAXO WELLCOME UK<br />

LTD<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 757<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ZOFRAN SYRUP ORAL LIQUID 4 MG/5ML GLAXO WELLCOME UK<br />

LTD<br />

ZOFRAN SYRUP ORAL LIQUID 4MG/5ML GLAXO WELLCOME UK<br />

LIMITED<br />

ZOFRAN TABLETS COATED TABLET 8MG GLAXO WELLCOME UK<br />

LIMITED<br />

ZOFRAN TABLETS COATED TABLETS 4MG GLAXO WELLCOME UK<br />

LIMITED<br />

ZOFRAN TABLETS 4MG COATED TABLET 4MG GLAXO WELLCOME UK<br />

LTD<br />

ZOFRAN TABLETS 8MG COATED TABLET 8MG GLAXO WELLCOME UK<br />

LTD<br />

ZOIRAL TABLETS 10MG AEGIS LTD CYPRUS<br />

ZOIRAL TABLETS 25MG AEGIS LTD CYPRUS<br />

ZOIRAL 10 CAPSULES 10MG AEGIS LTD. CYPRUS<br />

ZOIRAL 25 CAPSULES 25MG AEGIS LTD CYPRUS<br />

ZOIRAL 50 CAPSULES 50MG AEGIS LTD. CYPRUS<br />

ZOLADEX SOLUTION FOR<br />

INJECTION<br />

ZOLADEX LA SUSTAINED RELEASE<br />

DEPOT<br />

ZOLADEX LA SOLUTION FOR<br />

INJECTION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

3.6MG ZENECA LIMITED UNITED KINGDOM<br />

10.8MG ZENECA LIMITED UNITED KINGDOM<br />

10.8MG ZENECA LIMITED UNITED KINGDOM<br />

ZOLAREM 0.25 TABLETS 0.25MG AEGIS LTD. CYPRUS<br />

ZOLAREM 0.5 TABLETS 0.5MG AEGIS LTD. CYPRUS<br />

ZOLAREM 1 TABLET 1MG AEGIS LTD. CYPRUS<br />

ZOMETA POWDER F/SOLUTION F/<br />

INF.<br />

ZOMETA POWDER AND SOLVENT<br />

F/INF<br />

4MG/VIAL NOVARTIS PHARMA<br />

SCHWEIZ AG<br />

4MG/VIAL NOVARTIS EUROPHARM<br />

LIMITED<br />

SWITZERLAND<br />

EUROPEAN COMMUNITY<br />

ZOMIG COATED TABLETS 2.5MG ZENECA LIMITED UNITED KINGDOM<br />

ZOTON CAPSULES 15MG CYANAMID OF GREAT<br />

BRITAIN LTD.<br />

ZOTON CAPSULES 30MG CYANAMID OF GREAT<br />

BRITAIN LTD.<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ZOVIRAX CREAM 0.05G/G GLAXO WELLCOME PAKISTAN<br />

ZOVIRAX SUSPENSION 200MG/5ML GLAXO WELLCOME<br />

GMBH & CO<br />

GERMANY<br />

ZOVIRAX TABLETS 200MG GLAXOSMITHKLINE AB SWEDEN<br />

ZOVIRAX TABLETS 400MG GLAXOSMITHKLINE AB SWEDEN<br />

ZOVIRAX TABLETS 800MG GLAXOSMITHKLINE AB SWEDEN<br />

ZOVIRAX COLD SORE CREAM CREAM 5% W/W THE WELLCOME<br />

FOUNDATION LIMITED<br />

UNITED KINGDOM


EN<br />

758 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ZOVIRAX CREAM CREAM 0.5%W/W GLAXOWELLCOME PAKISTAN<br />

ZOVIRAX EYE OINTMENT 3%<br />

W/W<br />

EYE OINTMENT 3% W/W THE WELLCOME<br />

FOUNDATION LIMITED<br />

ZOVIRAX I.V. 250MG POWDER FOR INJECTION 250MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

ZOVIRAX SUSPENSION<br />

200MG/5ML<br />

ORAL SUSPENSION 200MG/5ML THE WELLCOME<br />

FOUNDATION LIMITED<br />

ZOVIRAX TABLETS 200MG TABLETS 200MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

ZOVIRAX TABLETS 400MG TABLETS 400MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

ZOVIRAX TABLETS 800MG TABLETS 800MG THE WELLCOME<br />

FOUNDATION LIMITED<br />

ZYBAN SUSTAINED RELEASE<br />

TABLETS<br />

ZYBAN PROLONGED RELEASE<br />

TABLETS<br />

150MG GLAXO WELLCOME INC. CANADA<br />

150MG GLAXO WELLCOME UK<br />

LTD<br />

ZYLORIC TABLETS 100MG THE WELLCOME<br />

FOUNDATION LTD.<br />

ZYLORIC TABLETS 300MG THE WELLCOME<br />

FOUNDATION<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

ZYLORIC TABLET 100MG GLAXO WELLCOME PAKISTAN<br />

ZYLORIC TABLET 100MG GLAXO WELLCOME PAKISTAN<br />

ZYLORIC TABLETS 100MG GLAXO WELLCOME SPA ITALY<br />

ZYLORIC SCORED TABLETS 300MG GLAXO WELLCOME SPA ITALY<br />

ZYMAFLUOR TABLETS 0.25MG NOVARTIS CONSUMER<br />

HEALTH SA<br />

ZYMAFLUOR TABLETS 1MG NOVARTIS CONSUMER<br />

HEALTH SA<br />

SWITZERLAND<br />

SWITZERLAND<br />

ZYMOPLEX TABLET 10MG GENEPHARM S.A. GREECE<br />

ZYOMET GEL 0.75%W/W GOLDSHIELD<br />

PHARMACEUTICALS<br />

LIMITED<br />

ZYPREXA COATED TABLETS 15MG ELI LILLY NEDERLAND<br />

BV<br />

ZYPREXA 10MG COATED TABLET 10MG ELI LILLY NEDERLAND<br />

BV<br />

UNITED KINGDOM<br />

EUROPEAN COMMUNITY<br />

NETHERLANDS<br />

ZYPREXA 10MG TABLETS 10MG LILLY PAKISTAN<br />

ZYPREXA 5MG COATED TABLET 5MG ELI LILLY NEDERLAND<br />

BV<br />

ZYPREXA 7.5MG COATED TABLET 7.5MG ELI LILLY NEDERLAND<br />

BV<br />

NETHERLANDS<br />

NETHERLANDS<br />

ZYRTEC TABLET 10MG UCB PHARMA S.A. FRANCE


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 759<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ZYRTEC ORAL SOLUTION 2.5MG/2.5ML UCB PHARMA S.A. FRANCE<br />

ZYRTEC TABLET 10MG UNITED CHEMICALS OF<br />

BELGIUM<br />

PAKISTAN<br />

ZYRTEC TABLET 10MG UCB PAKISTAN<br />

ZYRTEC ORAL SOLUTION 5MG/5ML UCB PAKISTAN<br />

ZYRTEC ORAL SOLUTION 2.5MG/2.5ML UCB PHARMA FRANCE<br />

ZYRTEC FILM COATED TABLETS 10MG UCB PHARMA FRANCE<br />

ZYRTEC SYRUP SYRUP 1MG/1ML UNITED CHEMICALS OF<br />

BELGIUM<br />

ZYTRAM XL TABLETS 300MG MODIFIED RELEASE<br />

TABLET<br />

300MG NAPP LABORATORIES<br />

LIMITED<br />

ZYTRAM XL TABLETS 400MG COATED TABLET 400MG NAPP LABORATORIES<br />

LIMITED<br />

ZYTRAM-XL TABLETS 150MG MODIFIED RELEASE<br />

TABLET<br />

ZYTRAM-XL TABLETS 200MG MODIFIED RELEASE<br />

TABLETS<br />

150MG NAPP LABORATORIES<br />

LIMITED<br />

200MG NAPP LABORATORIES<br />

LIMITED<br />

ZYVOX ORAL SUSPENSION NA PHARMACIA & UPJOHN<br />

COMPANY<br />

ZYVOX TABLETS 400MG PHARMACIA & UPJOHN<br />

COMPANY<br />

ZYVOX SOLUTION FOR<br />

INFUSION<br />

PAKISTAN<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED KINGDOM<br />

UNITED STATES OF<br />

AMERICA<br />

UNITED STATES OF<br />

AMERICA<br />

2MG/ML PHARMACIA NORGE AS NORWAY<br />

ZYVOX FILM COATED TABLETS 600MG PHARMACIA LIMITED UNITED KINGDOM<br />

ZYVOX SOLUTION FOR<br />

INFUSION<br />

2MG/ML PHARMACIA NORGE AS NORWAY<br />

ZYVOXID FILM-COATED TABLETS 600MG PHARMACIA NV/SA BELGIUM<br />

DAIVOBET OINTMENT NA LEO PHARMACEUTICAL<br />

PRODUCTS<br />

DENMARK<br />

ACTOPHLEM COUGH SYRUP SYRUP NA ADCOCK INGRAM PARK SOUTH AFRICA<br />

INGRAMS CAMPHOR CREAM CREAM 0.67G/100G ADCOCK INGRAM<br />

LIMITED<br />

LOCAINE A SOLUTION FOR<br />

INJECTION<br />

NA ADCOCK INGRAM<br />

LIMITED<br />

REMICAINE JELLY TOPICAL JELLY 2G/100G ADCOCK INGRAM<br />

LIMITED<br />

COMPRAL HEADACHE TABLETS TABLETS NA ADCOCK INGRAM<br />

LIMITED<br />

TEEJEL GEL NA ADCOCK INGRAM<br />

LIMITED<br />

SOLPHYLLEX SYRUP SYRUP NA ADCOCK INGRAM<br />

LIMITED<br />

GRIPPON CAPSULES CAPSULE NA ADCOCK INGRAM<br />

LIMITED<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA


EN<br />

760 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Trade Name Dosage Form Dose MA Holder Country<br />

ADCO-ACYCLOVIR 200MG TABLETS 200MG ADCOCK INGRAM<br />

LIMITED<br />

BIOPLUS S SYRUP NA ADCOCK INGRAM<br />

LIMITED<br />

MYPRODOL SUSPENSION SUSPENSION NA ADCOCK INGRAM<br />

LIMITED<br />

URIZONE 3 G GRANULES 3G/SACHET ADCOCK INGRAM<br />

LIMITED<br />

MEDI-KEEL A HONEY AND<br />

LEMON THROAT LOZENGES<br />

MEDI-KEEL A BLACKCURRANT<br />

THROAT LOZENGES<br />

LOZENGES NA ADCOCK INGRAM<br />

LIMITED<br />

LOZENGES NA ADCOCK INGRAM<br />

LIMITED<br />

NAZENE NASAL SPRAY NASAL SPRAY NA ADCOCK INGRAM<br />

LIMITED<br />

BIDOMAK FE LIQUID NA ADCOCK INGRAM<br />

LIMITED<br />

SABAX FOSENEMA SOLUTION NA ADCOCK INGRAM<br />

CRITICAL CARE (PTY)<br />

LTD<br />

LOTEM SUSPENSION SUSPENSION NA ADCOCK INGRAM<br />

LIMITED<br />

ADCO-ACYCLOVIR TOPICAL<br />

CREAM<br />

CREAM 250MG/5G ADCOCK INGRAM<br />

LIMITED<br />

ADCO-SODASOL GRANULES NA ADCOCK INGRAM<br />

LIMITED<br />

UNICROM 2% EYE DROPS<br />

BTL/5ML<br />

CALCIUM CHLORIDE<br />

10%-UNIMED<br />

MYDRICOL 0.5% EYE DROPS<br />

BTL/5ML<br />

TUSSCODIN RETARD —<br />

HUSTENSAFT<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

SOUTH AFRICA<br />

EYE DROPS 2% W/V UNIMED LABORATORY TUNISIA<br />

SOLUTION FOR<br />

INJECTION<br />

10% W/V UNIMED LABORATORY TUNISIA<br />

EYE DROPS 0.5% W/V UNIMED LABORATORY TUNISIA<br />

SYRUP 0.3G/100ML LANNACHER HEILMITTEL<br />

GmbH<br />

LEUKERAN 2MG TABLETS 2.1MG GLAXO WELLCOME<br />

GmbH & Co<br />

AUSTRIA<br />

GERMANY<br />

ALLERGOTIN-EYE DROPS SOLUTION 2%W/V COOPER SA GREECE<br />

CIPRALEX FILM-COATED TABLETS<br />

20MG<br />

CIPRALEX FILM-COATED TABLETS<br />

15MG<br />

CIPRALEX FILM-COATED TABLETS<br />

10MG<br />

CIPRALEX FILM-COATED TABLETS<br />

5MG<br />

TABLETS 20MG H. LUNDBECK A/S DENMARK<br />

TABLETS 15MG H. LUNDBECK A/S DENMARK<br />

TABLETS 10MG H. LUNDBECK A/S DENMARK<br />

TABLETS 5MG H. LUNDBECK A/S DENMARK<br />

URO VAXOM CAPSULES 6MG OM PHARMA SWITZERLAND


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 761<br />

Trade Name Dosage Form Dose MA Holder Country<br />

HAEMOKION INJECTION SOLUTION FOR<br />

INJECTION<br />

10MG/ML AMOUN<br />

PHARMACEUTICALS CO.<br />

S.A.E.<br />

LYSOVIR 100MG CAPSULES CAPSULES 100MG ALLIANCE<br />

PHARMACEUTICALS<br />

LIMITED<br />

EGYPT<br />

UNITED KINGDOM<br />

AQUEOUS CREAM BP CREAM CREAM 30% W/W JM LOVERIDGE PLC UNITED KINGDOM<br />

TUSCALMAN SYRUP NA LABORATORIO<br />

FARMACEUTICO S.I.T.<br />

AUSTRIA


EN<br />

762 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

CS,PE,COM<br />

MILK PROCESSING ESTABLISHMENT (1)<br />

Appendix B<br />

referred to in Chapter 4, Section B, Subsection I, point 1 of Annex XI (*)<br />

List of establishments<br />

No Licence No Name of establishment<br />

1 MM 01 Malta Dairy Products<br />

(*) For the text of Annex XI see OJ L 236, 23.9.2003, p. 859.<br />

Appendix C<br />

referred to in Chapter 4, Section B, Subsection I, point 2 of Annex XI (*)<br />

List of establishments with non-enriched cage system subject to transitional arrangements (Directive<br />

1999/74/EC, Article 5(1)(4) and Article 5(1)(5))<br />

ANIMAL WELFARE<br />

No Name of the establishment Licence No. No. of laying hens<br />

1 Gauci M'Louise PBLM051 (11 000) only the cages fulfilling the terms of the<br />

transitional measure are covered<br />

2 Micallef Paul PBLM064 8 000<br />

3 Vella Samuel PBLM079 9 500<br />

4 Mifsud Jude PBLM065 7 100<br />

5 Zammit Francis PBLM081 500<br />

6 Camilleri Anna PLM007 2 200<br />

7 Vella Joseph PLG018 2 670<br />

8 Busuttil PBLM024 (6 000) only the cages installed in 2000 fulfilling the<br />

terms of the transitional measure are covered<br />

9 Gatt Victor PLG008 12 200<br />

10 Grech Saviour PBLM053 1 698<br />

11 Lumach Co Ltd PLM016 15 000<br />

12 Vella Kalcidon PLM024 9 000<br />

(*) For the text of Annex XI see OJ L 236, 23.9.2003, p. 859.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 763<br />

Appendix A<br />

referred to in Chapter 1, points 4 and 5 of Annex XII (*)<br />

List as provided by Poland in one language of pharmaceutical products for which a marketing authorisation issued<br />

under Polish law prior to the date of accession shall remain valid until it is renewed in compliance with the acquis or<br />

until 31 December 2008, whichever is the earlier.<br />

Mention on this list does not prejudge whether or not the pharmaceutical product in question has a marketing<br />

authorisation in compliance with the acquis.<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1 0,9 % Sodium Chloride-<br />

BRAUN<br />

Natrii chloridum Solution for infusion 9 mg/ml B. Braun Melsungen AG 26/04/06<br />

2 10 % Dekstran 40 000 Dextranum Solution for infusion 100 mg/ml Baxter Terpol Sp. z o.o. 31/12/08<br />

3 26 RANUNCULUS-Dago-med.<br />

opryszczka wargowa<br />

4 27 ABROTANUM-Dagomed<br />

tra˛dzik róz˙owaty<br />

5 28 SULFUR-Dagomed tra˛dzik<br />

pospolity<br />

6 29 HYDROCOTYLE-Dagomed<br />

zmiany łuszczycowe<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

9 3 TC Lamivudinum Film-coated tablets 150 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

10 3 TC Lamivudinum Film-coated tablets 150 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

7 3 TC Lamivudinum Syrup 10 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

8 3 TC Lamivudinum Syrup 10 mg/ml GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

11 30 MEZEREUM-Dagomed<br />

nerwobóle, półpasiec<br />

12 31 THUJA-Dagomed<br />

brodawki, kurzajki<br />

13 32 BELLADONNA-Dagomed<br />

wysypki w chorobach<br />

zakaz´nych u dzieci<br />

14 324 pojedyncze<br />

prep.homeopatyczne wg listy<br />

15 33 SECALE-Dagomed<br />

miaz˙dz˙yca naczyń obwodowych<br />

16 34 BARIUM-Dagomed<br />

zaburzenia pamie˛ci<br />

17 35 MAGNESIUM-Dagomed<br />

kolki jelitowe<br />

18 36 RUTA-Dagomed urazy<br />

s´cie˛gien i mie˛s´ni<br />

19 37 BRYONIA-Dagomed bóle<br />

barkowe i szyjne<br />

(*) For the text of Annex XII see OJ L 236, 23.9.2003, p. 875.<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DHU-Arzneimittel GmbH<br />

& Co.KG<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/03/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06


EN<br />

764 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

20 38 COLOCYNTHIS-Dagomed<br />

rwa kulszowa, lumbago<br />

21 39 PASSIFLORA-Dagomed<br />

nadpobudliwos´ć, bezsennos´ć<br />

22 40 LUFFA-Dagomed katar<br />

sienny<br />

23 41 MERCURIUS-Dagomed<br />

anginy ropne<br />

24 42 CONIUM-Dagomed stany<br />

zapalne migdałków<br />

podniebiennych<br />

25 43 BORAX-Dagomed<br />

zapalenia i grzybice jamu<br />

ustnej<br />

26 44 CHAMOMILLA-Dago-med.<br />

bolesne za˛bkowanie<br />

27 45 ACIDUM NITRICUM-<br />

Dagomed stany zapalne<br />

s´luzówki<br />

28 46 ECHINACEA-Dagomed<br />

nawracaja˛ce infekcje<br />

29 47 THALLIUM-Dagomed<br />

wypadanie włosów, łysienie<br />

30 48 KREOZOTUM-Dagomed<br />

upławy<br />

31 49 VIBURNUM-Dagomed<br />

bolesne miesia˛czki<br />

32 4XLA Kwas mlekowy,<br />

chloryn sodu<br />

Liquid for veterinary<br />

use<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

31/12/06<br />

Alcide Corporation USA 31/12/08<br />

33 5- Fluorouracyl Fluorouracilum Solution for injection 50 mg/ml PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

34 50 TABACUM-Dagomed<br />

uzalez˙nienie nikotynowe<br />

35 51 Cr-EDTA do wstrzykiwań Preparat<br />

radiodiagnostyczny<br />

36 5-Ala Methyl aminolevulinate<br />

hydrochloride<br />

37 5-Fluorouracil-Ebewe, 5-<br />

Fluorouracyl-Knoll<br />

Fluorouracilum Solution for injection,<br />

intravenous and<br />

intraarterial infusion<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

Solution for injection Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Cream 6 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/06<br />

31/12/08<br />

31/12/08<br />

50 mg/ml EBEWE Arzneimittel GmbH 30/11/04<br />

38 6 % Dekstran 70 000 Dextranum Solution for infusion 60 mg/ml Baxter Terpol Sp. z o.o. 31/12/08<br />

39 A 20 Acidum<br />

acetylsalicylicum<br />

Powder for veterinary<br />

use<br />

Vetos-Farma 31/12/08<br />

42 Abaktal Pefloxacinum Film-coated tablets 0.4 g Lek Pharmaceuticals d.d. 30/04/04<br />

43 Abaktal Pefloxacinum Film-coated tablets 0.4 g Lek Polska Sp. z o.o. 30/10/05<br />

40 Abaktal Pefloxacinum Solution for<br />

intravenous infusion<br />

80 mg/ml Lek Pharmaceuticals d.d. 30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 765<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

41 Abaktal Pefloxacinum Solution for<br />

intravenous infusion<br />

44 Abamitel L.A inj. Abamectinum Solution for veterinary<br />

use<br />

45 Abamitel Plus Abamectinum +<br />

Praziquantelum<br />

Paste for veterinary<br />

use<br />

46 Abbocurium Atracurii besilas Solution for injection<br />

and intravenous<br />

infusion<br />

47 Abbofol 1 % Propofolum Emulsion for injection<br />

and intravenous<br />

infusion<br />

48 ABBOTAXIM 1 g Cefotaximum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

49 ABBOTAXIM 2 g Cefotaximum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

50 ABBOTAXIM 500 mg Cefotaximum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

51 ABBOTRIAXON 1 g Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

52 ABBOTRIAXON 2 g Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

53 ABBOTRIAXON 500 mg Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

54 Abbovancomycin Vancomycinum Powder for solution<br />

for infusion<br />

55 Abbovancomycin Vancomycinum Powder for solution<br />

for infusion<br />

56 Abbovir Aciclovirum Powder for solution<br />

for infusion<br />

57 Abbovir Aciclovirum Powder for solution<br />

for infusion<br />

80 mg/ml Lek Polska Sp. z o.o. 30/10/05<br />

KRKA 31/12/08<br />

KRKA 31/12/08<br />

10 mg/ml Abbott Laboratoires 31/05/05<br />

10 mg/ml Abbott Laboratories 30/06/04<br />

1 g Abbott Laboratories Poland<br />

Sp. z o.o.<br />

2 g Abbott Laboratories Poland<br />

Sp. z o.o.<br />

500 mg Abbott Laboratories Poland<br />

Sp. z o.o.<br />

1 g Abbott Laboratories Poland<br />

Sp. z o.o.<br />

2 g Abbott Laboratories Poland<br />

Sp. z o.o.<br />

500 mg Abbott Laboratories Poland<br />

Sp. z o.o.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

500 mg Abbott France S.A. 31/12/08<br />

1 g Abbott France S.A. 31/12/08<br />

250 mg Abbott Laboratories 11/10/06<br />

500 mg Abbott Laboratories 11/10/06<br />

58 ABC-Salbe Ointment Beiersdorf AG 31/12/08<br />

59 Abdomilon Oral solution Julius Redel CESRA —<br />

Arzneimittelfabrik GmbH<br />

60 ABE — płyn do usuwania<br />

odcisków<br />

61 Abelcet Amphotericinum B Suspension for<br />

intravenous infusion<br />

Coutanous liquid Inco-Veritas S.A. Oddział w<br />

Pruszkowie; Celia Zakład<br />

Produkcji Kosmetyczno-<br />

Farmaceutycznej<br />

5 mg/ml ELAN PHARMA<br />

INTERNATIONAL Ltd.<br />

30/04/04<br />

30/10/05<br />

30/09/07


EN<br />

766 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

62 Abropernol Tablets Heel GmbH 31/12/08<br />

63 Abutol Acebutololum Film-coated tablets 200 mg Schwarz Pharma Sp. z o.o. 31/12/04<br />

64 Abutol Long 400 Acebutololum Gastro-resistant,<br />

prolonged release<br />

tablets<br />

400 mg Schwarz Pharma Sp. z o.o. 12/10/05<br />

65 Acard Acidum acetylsalicylicum Film-coated tablets 75 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

66 Acatar Oxymetazolini<br />

hydrochloridum<br />

67 ACC Acetylcysteinum Granules for oral<br />

solution<br />

68 ACC Acetylcysteinum Solution for<br />

intravenous injection<br />

or for respiratory<br />

system<br />

Nasal spray, solution 0.05 % US Pharmacia International<br />

Inc.<br />

13/06/06<br />

31/10/05<br />

20 mg/ml Hexal AG 30/09/05<br />

300 mg/3 ml Hexal AG 31/12/08<br />

71 ACC 100 Acetylcysteinum Effervescent tablets 100 mg Hexal AG 31/01/05<br />

69 ACC 100 Acetylcysteinum Granules for oral<br />

solution<br />

100 mg Hexal AG 31/01/05<br />

70 ACC 100 Acetylcysteinum Tablets 100 mg Hexal AG 15/11/06<br />

73 ACC 200 Acetylcysteinum Capsules 200 mg Hexal AG 31/01/05<br />

75 ACC 200 Acetylcysteinum Effervescent tablets 200 mg Hexal AG 31/01/05<br />

72 ACC 200 Acetylcysteinum Granules for oral<br />

solution<br />

200 mg Hexal AG 31/01/05<br />

74 ACC 200 Acetylcysteinum Tablets 200 mg Hexal AG 15/11/06<br />

76 ACC 200 Hot Acetylcysteinum Granules for oral<br />

solution<br />

200 mg/3 g Hexal AG 5/07/06<br />

77 Acc 300 Acetylcysteinum Tablets 300 mg HEXAL AG 31/12/08<br />

78 ACC 600 Acetylcysteinum Effervescent tablets 600 mg Hexal AG 6/12/06<br />

79 Acc 600 Acetylcysteinum Tablets 600 mg HEXAL AG 6/12/06<br />

80 ACC 600 Hot Acetylcysteinum Granules for oral<br />

solution<br />

600 mg/3g Hexal AG 5/07/06<br />

81 Acceptin Tianeptinum Tablets 12,5 mg Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

31/12/08<br />

82 Accolate Zafirlukastum Film-coated tablets 10 mg Astra Zeneca UK Ltd. 29/11/06<br />

83 Accolate Zafirlukastum Film-coated tablets 20 mg AstraZeneca UK Ltd. 31/12/08<br />

84 Accupro 10 Quinaprilum Film-coated tablets 10 mg Gödecke AG 30/06/07<br />

85 Accupro 20 Quinaprilum Film-coated tablets 20 mg Gödecke AG 30/06/07<br />

86 Accupro 40 Quinaprilum Film-coated tablets 40 mg Gödecke GmbH 31/12/08<br />

87 Accupro 5 Quinaprilum Film-coated tablets 5 mg Gödecke AG 30/06/07<br />

88 Accuzide Hydrochlorothiazidum +<br />

Quinaprilum<br />

Film-coated tablets 12,5mg +<br />

10mg<br />

Parke-Davis GmbH —<br />

Freiburg<br />

12/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 767<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

89 Accuzide 20 Hydrochlorothiazidum +<br />

Quinaprilum<br />

Film-coated tablets 12,5mg +<br />

20mg<br />

Parke-Davis GmbH —<br />

Freiburg<br />

12/10/05<br />

90 Acebutolol Acebutololum Film-coated tablets 200 mg Sanofi-Synthelabo Sp. z o.o. 30/09/05<br />

91 Acebutolol Acebutololum Tablets 200 mg Merck Sp. z o.o. 30/09/05<br />

92 Acebutolol Acebutololum Tablets 400 mg Merck Sp. z o.o. 30/09/05<br />

93 Acecor Acebutololum Film-coated tablets 200 mg SPA Societa Prodotti<br />

Antibiotici SpA<br />

94 Acecor Acebutololum Film-coated tablets 400 mg SPA Societa Prodotti<br />

Antibiotici SpA<br />

95 Acenocoumarol Acenocoumarolum Tablets 4 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

96 Acenocumarol Acenocoumarolum Tablets 4 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

97 Acenocumarol WZF Acenocoumarolum Tablets 1 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

98 Acenol Paracetamolum Tablets 300 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

99 Acenol cum Coffeino Caffeinum et natrii<br />

benzoas +<br />

Paracetamolum<br />

Tablets Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

100 Acenol Forte Paracetamolum Tablets 500 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

101 Aceprovet Acetylopromazyny<br />

maleinian<br />

102 Acerin Acidum lacticum +<br />

Acidum salicylicum<br />

Gel for veterinary<br />

use<br />

30/04/04<br />

26/04/06<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

31/12/05<br />

31/12/05<br />

31/01/06<br />

Biowet Drwalew 31/12/08<br />

Coutanous liquid Scan-Anida sp. z o.o. 31/01/06<br />

103 Acerola Buccal tablet 100 mg Puritan's Pride, Incorporated 31/12/08<br />

104 Acesan Acidum<br />

acetylosalicylicum<br />

Film-coated tablets 80 mg Sun — Farm Sp. z o.o. 30/10/05<br />

105 Acesan Acidum acetylsalicylicum Tablets 30 mg Sun Farm Sp. z o.o. 30/10/05<br />

106 Acesan Acidum acetylsalicylicum Tablets 50 mg Sun Farm Sp. z o.o. 30/10/05<br />

107 Acesan Acidum acetylsalicylicum Tablets 75 mg Sun Farm Sp. z o.o. 30/10/05<br />

108 Acespargin Acidum asparticum Tablets 46 mg K+ Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’, Bydgoszcz<br />

31/01/06<br />

109 Acetat — Nefro Calcii acetas Film-coated tablets 500 mg Salmon Pharma 31/12/08<br />

110 Acetylocysteine Acetylcysteinum Effervescent tablets 200 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

111 Acetylocysteine Acetylcysteinum Effervescent tablets 600 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

112 Acevita Buccal tablets Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

113 Acevor Roxithromycinum Film-coated tablets 150 mg Help S.A. Pharmaceuticals<br />

Attica<br />

114 Aciclovir Aciclovirum Powder for solution<br />

for intravenous<br />

infusion<br />

0.25 g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/10/05


EN<br />

768 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

115 Acicord Acebutolum Tablets 200 mg Polfarmex S.A. 31/12/08<br />

116 Acicord Acebutolum Tablets 400 mg Polfarmex S.A. 31/12/08<br />

117 Acidoflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

118 Acidum e-aminocapronicum Acidum aminocaproicum Powder Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

119 Acidum e-aminocapronicum<br />

granulatum<br />

Acidum aminocaproicum Granules 50 g/100 g Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

120 Acidum folicum Acidum folicum Tablets 15 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

121 Acidum folicum Acidum folicum Tablets 5 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

29/01/06<br />

30/10/05<br />

30/10/05<br />

30/11/05<br />

30/11/05<br />

122 Acidum Folicum Acidum folicum Tablets 0,4 mg Polfarmex S.A. 30/11/05<br />

123 Acidum Folicum Acidum folicum Tablets 5 mg Polfarmex S.A. 30/11/05<br />

124 Acidum Folicum Acidum folicum Tablets 15 mg Polfarmex S.A. 30/11/05<br />

125 Acidum Folicum 15 mg Acidum folicum Tablets 15 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

126 Acidum Folicum 5 mg Acidum folicum Tablets 5 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

127 Acidum phosphoricum<br />

complexe nr 5<br />

128 Acidum phosphoricum compose<br />

krople<br />

31/12/08<br />

31/12/08<br />

Drops Lehning Laboratoires 31/03/06<br />

Dolisos Laboratoires 31/12/08<br />

129 Acifolik Acidum folicum Tablets 0,4 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

130 Acifungin Preparat złoz˙ony Coutanous liquid Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

131 Acifungin forte Preparat złoz˙ony Coutanous liquid Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

132 Acix 250 Aciclovirum Powder for solution<br />

for infusion<br />

133 Acix 500 Aciclovirum Powder for solution<br />

for infusion<br />

31/12/08<br />

31/01/06<br />

31/01/06<br />

250 mg Hexal AG 8/02/06<br />

500 mg Hexal AG 8/02/06<br />

134 Aclotin Ticlopidinum Film-coated tablets 250 mg ICN Polfa Rzeszów S.A. 7/05/06<br />

135 Acne Sulf Cutaneous emulsion 100 mg/g R & C — Przedsie˛biorstwo<br />

Farmaceutyczne s.c.<br />

136 Acnecin Erythromycinum Coutanous liquid 2 % Przedsie˛biorstwo<br />

Farmaceutyczne R i C<br />

137 Acne-Derm Acidum azelaicum Cream 200 mg/g Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

138 Acneflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

31/01/06<br />

31/12/08<br />

23/11/05<br />

30/04/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 769<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

139 Acnevulten fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp. z<br />

o.o. — Zastawna<br />

140 Acnosan Tioxolonum Coutanous liquid 5 mg/g Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

31/08/05<br />

31/01/06<br />

141 Acodin Dextromethorphanum Tablets 15 mg Sanofi-Synthelabo Sp. z o.o. 30/10/05<br />

142 Acodin 150 Dexpanthenolum +<br />

Dextromethorphanum<br />

143 Acodin 300 Dexpanthenolum +<br />

Dextromethorphanum<br />

Syrup (50mg +<br />

7,5mg)/5ml<br />

Syrup (50mg +<br />

15mg)/5ml<br />

Sanofi-Synthelabo Sp. z o.o. 30/10/05<br />

Sanofi-Synthelabo Sp. z o.o. 30/10/05<br />

144 Aconit olej przeciwbólowy Oil WALA-Heilmittel GmbH 30/04/07<br />

145 Aconitum comp. granulki WALA-Heilmittel GmbH 31/08/05<br />

146 Aconitum comp. inj. WALA-Heilmittel GmbH 31/08/05<br />

147 Aconitum comp. krople do<br />

uszu<br />

WALA-Heilmittel GmbH 31/08/05<br />

148 Aconitum compose krople Dolisos Laboratoires 31/12/08<br />

149 Aconitum Pentarkan Tablets DHU-Arzneimittel GmbH &<br />

Co.KG<br />

4/07/06<br />

150 Aconitum/China comp. Suppository 1 g WALA-Heilmittel GmbH 24/04/07<br />

151 Aconitum/China comp.<br />

granulki<br />

WALA-Heilmittel GmbH 31/08/05<br />

152 Aconitum-Dagomed 1 grypa DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

153 Aconitum-Homaccord Amp. Heel GmbH 31/12/08<br />

154 Aconitum-Homaccord Oral drops Heel GmbH 31/12/08<br />

155 Act-HiB Hemophilus influenzae<br />

B, purified antigen<br />

conjugated<br />

156 Actifed Triprolidinum +<br />

Dextromethorphanum +<br />

Pseudoephedrinum<br />

Lyophilisate and<br />

solvent for solution<br />

for subcutaneous and<br />

intramuscular<br />

injection<br />

157 Actilyse 10 Alteplasum Powder and solvent<br />

for solution for<br />

infusion<br />

158 Actilyse 20 Alteplasum Powder and solvent<br />

for solution for<br />

infusion<br />

159 Actilyse 50 Alteplasum Powder and solvent<br />

for solution for<br />

infusion<br />

160 Activelle Estradiolum +<br />

Norethisteronum<br />

10 mcg Aventis Pasteur S.A. 30/04/05<br />

Syrup Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

10 mg Boehringer Ingelheim<br />

International GmbH<br />

20 mg Boehringer Ingelheim<br />

International GmbH<br />

50 mg Boehringer Ingelheim<br />

International GmbH<br />

30/04/05<br />

15/11/06<br />

30/04/04<br />

30/04/04<br />

Film-coated tablets Novo Nordisk A/S 30/11/04<br />

161 Actonel Risedronatum Film-coated tablets 30 mg Aventis Pharma AB 14/12/05<br />

162 Actonel Risedronatum Film-coated tablets 5 mg Aventis Pharma AB 14/12/05


EN<br />

770 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

163 Actos Pioglitazonum Tablets 15 mg Lilly Spain S.A. 31/12/08<br />

164 Actos Pioglitazonum Tablets 30 mg Lilly Spain S.A. 31/12/08<br />

165 Actrapid HM Insulini injectio neutralis Solution for injection 100 j.m./ml Novo Nordisk A/S 31/07/04<br />

166 Actrapid HM Insulini injectio neutralis Solution for injection 40 j.m./ml Novo Nordisk A/S 31/07/04<br />

167 Actrapid HM Penfill Insulini injectio neutralis Solution for injection 100 j.m./ml Novo Nordisk A/S 31/07/04<br />

168 Actrapid Innolet Insulini injectio neutralis Solution for injection 100 j.m. Novo Nordisk A/S 5/07/06<br />

169 Actrapid MC Insulini injectio neutralis Solution for injection 40 j.m./ml Novo Nordisk A/S 31/07/04<br />

170 ACTRAPID MC 100 J.M./Ml Insulini injectio neutralis Solution for<br />

subcutanous injection<br />

100 j.m./ml Novo Nordisk A/S 31/12/08<br />

171 Actrapid NovoLet Insulini injectio neutralis Solution for injection 100 j.m./ml Novo Nordisk A/S 31/03/05<br />

172 Acudex Dextranomerum Medicated powder 4 g Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

173 Acular Ketorolacum<br />

trometamolum<br />

31/01/06<br />

Eye drops 5 mg/ml Allergan Pharmaceuticals Ltd. 31/12/08<br />

174 Acurenal Quinaprilum Film-coated tablets 5 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

175 Acurenal Quinaprilum Film-coated tablets 10 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

176 Acurenal Quinaprilum Film-coated tablets 20 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

177 Acyclostad Aciclovirum Cream 50 mg/g STADApharm GmbH 17/01/07<br />

178 Acyclovir 200 Stada Aciclovirum Tablets 200 mg STADApharm GmbH 31/12/08<br />

179 Acyclovir 400 Stada Aciclovirum Tablets 400 mg STADApharm GmbH 31/12/08<br />

180 Acyclovir 800 Stada Aciclovirum Tablets 800 mg STADApharm GmbH 31/12/08<br />

181 Acyklowir 200 Aciclovirum Tablets 200 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

182 Acyklowir 400 Aciclovirum Tablets 400 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

183 Acypront Acetylcysteinum Effervescent tablets 200 mg Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

184 AD Live Suivax Szczepionka<br />

przeciwko chorobie<br />

Aujeszkyego<br />

Lyophilisate for veterinary<br />

use<br />

31/07/05<br />

31/07/05<br />

24/05/06<br />

Fatro 31/12/08<br />

185 Adalat Nifedipinum Capsules 10 mg Bayer AG 31/07/04<br />

186 Adalat Gits 20 Nifedipinum Film-coated, prologed<br />

release tablets<br />

187 Adalat Gits 30 Nifedipinum Film-coated, prologed<br />

release tablets<br />

188 Adalat Gits 60 Nifedipinum Film-coated, prologed<br />

release tablets<br />

189 Adalat pro infusione Nifedipinum Solution for<br />

intravenous infusion<br />

20 mg Bayer AG 31/05/05<br />

30 mg Bayer AG 31/05/05<br />

60 mg Bayer AG 31/05/05<br />

0.1 mg/ml Bayer AG 6/07/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 771<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

190 Adalat Retard Nifedipinum Film-coated, prologed<br />

release tablets<br />

191 Adamon SR 100 Tramadolum Prolonged release<br />

capsules<br />

192 Adamon SR 150 Tramadolum Prolonged release<br />

capsules<br />

193 Adamon SR 200 Tramadolum Prolonged release<br />

capsules<br />

194 Adamon SR 50 Tramadolum Prolonged release<br />

capsules<br />

20 mg Bayer AG 31/07/04<br />

100 mg Asta Medica AG 11/10/06<br />

150 mg Asta Medica AG 11/10/06<br />

200 mg Asta Medica AG 11/10/06<br />

50 mg Asta Medica AG 11/10/06<br />

195 Adapalene Adapalenum Cream 0,10 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

196 Adapalene Adapalenum Gel 0,10 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/08<br />

197 Adavin Nicergolinum Coated tablets 10 mg Lek Pharmaceuticals d.d. 30/06/04<br />

198 Adavin Nicergolinum Coated tablets 10 mg Lek Polska Sp. z o.o. 31/12/05<br />

199 Adavin Nicergolinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

200 Adavin Nicergolinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

201 Addamel N Concentrate for<br />

solution for infusion<br />

202 Addiphos Kalii dihydrophosphas +<br />

Natrii hydrophosphas +<br />

Kalii hydroxydum<br />

203 Additiva Calcium. Musuja˛ce<br />

tabletki z wapniem<br />

Concantrate for<br />

solution for<br />

intravenous infusion<br />

4 mg Lek Polska Sp. z o.o. 31/01/05<br />

4 mg Lek Pharmaceuticals d.d. 31/01/05<br />

(170,1mg +<br />

133,5mg +<br />

14mg)/ml<br />

Fresenius Kabi AB Uppsala 31/07/04<br />

Fresenius Kabi AB Uppsala 31/07/04<br />

Calcii carbonas Effervescent tablets 0.15 g Ca++ N.P. Pharma Sp. z o.o. 31/12/06<br />

204 Additiva Ferrum Ferrosi gluconas Effervescent tablets 18 mg Fe++ N.P. Pharma Sp. z o.o. 31/12/06<br />

205 Additiva Magnesium. Musuja˛ce<br />

tabletki z magnezem<br />

206 Additiva Multivitamina o<br />

smaku owoców tropikalnych<br />

207 Additiva Multivitamina o<br />

smaku pomarańczowym<br />

208 Additiva Multivitamina z<br />

minerałami o smaku mango<br />

209 Additiva Multivitamina z<br />

minerałami o smaku<br />

pomarańczowym<br />

210 Additiva Witamina C Acidum ascorbicum<br />

(vit C)<br />

211 Additiva Witamina C o smaku<br />

cytrynowym<br />

212 Additiva Witamina C o smaku<br />

pomarańczowym<br />

Magnesii carbonas Effervescent tablets 0.15 g Mg++ N.P. Pharma Sp. z o.o. 31/12/06<br />

Acidum ascorbicum<br />

(vit C)<br />

Acidum ascorbicum<br />

(vit C)<br />

Effervescent tablets N.P. Pharma Sp. z o.o. 31/12/06<br />

Effervescent tablets N.P. Pharma Sp. z o.o. 31/12/06<br />

Effervescent tablets N.P. Pharma Sp. z o.o. 31/12/06<br />

Effervescent tablets N.P. Pharma Sp. z o.o. 31/12/06<br />

Effervescent tablets 200 mg N.P. Pharma Sp. z o.o. 31/01/05<br />

Effervescent tablets 1 g N.P. Pharma Sp. z o.o. 31/12/06<br />

Effervescent tablets 1 g N.P. Pharma Sp. z o.o. 31/12/06


EN<br />

772 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

213 Adenipravac — ND/IB Inaktywowana<br />

szczepionka dla kur<br />

przeciwko rzekomemu<br />

pomorowi drobiu,<br />

zakaz´nemu zapaleniu<br />

oskrzeli i syndromowi<br />

spadku nies´nos´ci<br />

Water — oil emulsion for veterinary<br />

use<br />

Laboratorios Hipra S.A. 22/11/06<br />

214 Adenocor Adenosinum Solution for injection 3 mg/ml Sanofi Winthrop-Gentilly 21/11/05<br />

215 Adenosin-Ebewe Adenosinum Solution for<br />

intravenous injection<br />

3 mg/ml EBEWE Arzneimittel GmbH 31/07/05<br />

216 Adexor Trimetazidinum Film-coated tablets 20 mg Egis Pharmaceuticals Ltd. 31/07/05<br />

217 Adiab Acarbosum Tablets 100 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

218 Adiab Acarbosum Tablets 50 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

219 Adipobonisan Instant herbal tea Laboratorium Medycyny<br />

Naturalnej ‘BONIMED’,<br />

Z˙ywiec<br />

220 Adipobonisol Oral solution Laboratorium Medycyny<br />

Naturalnej ‘BONIMED’,<br />

Z˙ywiec<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

221 Adiposan Herba Oskar, Wierzbówiec 31/12/08<br />

222 Adiposina Herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

223 Adiposina Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

30/10/05<br />

30/10/05<br />

224 Adiuretin Desmopressinum Nasal drops, solution 100 mcg/1 ml Ferring Lečiva a.s. 31/05/04<br />

225 Adiuretin Desmopressinum Solution for injection 4 mcg/1 ml Ferring Lečiva a.s. 31/05/04<br />

226 Adiusol ADE Retynolu palmitynian,<br />

Cholekalcyferol,<br />

D,µtokoferolu octan<br />

Solution for veterinary<br />

use<br />

Vetem 31/01/05<br />

<strong>227</strong> Adonis Afrodyta Coutanous liquid Elanda s.c. — Zakład<br />

Produkcji S´ rodków<br />

Farmaceutycznych<br />

31/08/05<br />

228 Adrecard Acebutolum Film-coated tablets P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

229 Adriblastina PFS Doxorubicinum Solution for<br />

intravenous injection<br />

230 Adriblastina PFS Doxorubicinum Solution for<br />

intravenous injection<br />

232 Adriblastina RD Doxorubicinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

231 Adriblastina RD Doxorubicinum Lyophilisate for<br />

solution for injection<br />

233 Adrimedac Doxorubicinum Solution for<br />

intravenous injection<br />

234 Adult Meltus Expectorant For<br />

Chesty Coughs And Catarrh<br />

2 mg/ml Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

2 mg/ml Pharmacia Upjohn Pty Ltd.<br />

Bentley<br />

10 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

50 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

2 mg/ml medac Gesellschaft für<br />

klinische Spezialpräparate<br />

mbH<br />

31/01/05<br />

26/11/06<br />

30/06/04<br />

30/06/04<br />

31/12/08<br />

Preparat złoz˙ony Liquid Seton Healthcare Group 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 773<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

235 Advantage Imidakloprid Solution for veterinary<br />

use<br />

237 Advantan Methylprednisoloni<br />

aceponas<br />

236 Advantan Methylprednisoloni<br />

aceponas<br />

238 Advantan Methylprednisoloni<br />

aceponas<br />

239 Advera (o smaku<br />

czekoladowym)<br />

240 Advera (o smaku<br />

pomarańczowym)<br />

Bayer 31/12/08<br />

Cream 1 mg/g Schering AG 30/06/07<br />

Emulsion 1 mg/g Schering AG 30/06/07<br />

Ointment 1 mg/g Schering AG 30/06/07<br />

Preparat odz˙ywczy Liquid Ross Products Division-<br />

Abbott Laboratories<br />

Preparat odz˙ywczy Liquid Ross Products Division-<br />

Abbott Laboratories<br />

241 Advil Ibuprofenum Film-coated tablets 200 mg Wyeth-Lederle Pharma GmbH<br />

Division Whitehall<br />

242 Advil Ibuprofenum Film-coated tablets 400 mg Wyeth — Lederle Pharma<br />

GmbH<br />

243 Advil Cold Ibuprofenum +<br />

Pseudoephedrinum<br />

Film-coated tablets Wyeth-Lederle Pharma GmbH<br />

Division Whitehall<br />

244 Advil Junior Ibuprofenum Oral suspension 100 mg/5 ml Wyeth — Lederle Pharma<br />

GmbH<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/08/04<br />

31/12/08<br />

245 Advil Ultra Ibuprofenum Capsules, soft 200mg Wyeth Lederle Pharma GmbH 27/06/07<br />

246 Advocin SP Danofloksacyna Powder for veterinary<br />

use<br />

Pfizer 21/05/04<br />

248 Aerius Desloratadinum Film-coated tablets 5 mg Schering-Plough Europe<br />

Bruksela<br />

247 Aerius Desloratadinum Syrup 0,5 mg/ml Schering — Plough Central<br />

East S.A.<br />

17/01/07<br />

17/01/07<br />

249 AEROBEC Autohaler Beclomethasonum Pressurised inhalation 50 µg/dawke˛ 3 M Health Care Limited 31/12/08<br />

250 AEROBEC Autohaler Beclomethasonum Pressurised inhalation 100 µg/dawke˛ 3 M Health Care Limited 31/12/08<br />

251 AEROBEC Inhaler Beclomethasonum Pressurised inhalation 50 µg/dawke˛ 3 M Health Care Limited 31/12/08<br />

252 AEROBEC Inhaler Beclomethasonum Pressurised inhalation 100 µg/dawke˛ 3 M Health Care Limited 31/12/08<br />

253 Aerosonit Isosorbidi dinitras Oromusosal spray,<br />

solution<br />

254 Aerrane Isofluranum Liquid for inhalation<br />

anaesthesia<br />

1.25 mg/dawke˛ GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/12/05<br />

Baxter S.A. 12/09/07<br />

255 Aescin Escinum Film-coated tablets 20 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

256 Aescin Escinum + Diethylamini<br />

salicylas + Heparinum<br />

257 Aesciven Natrii escinas +<br />

Diethylamini salicylas<br />

258 Aesculaforce Hippocastani semen<br />

extractum siccum<br />

259 Aesculan Aesculinum +<br />

Lidocainum<br />

Gel (20mg + 50mg<br />

+ 50 j.m.)g<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Gel (1mg + 5mg)/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/01/06<br />

31/12/05<br />

31/12/08<br />

Film-coated tablets 20 mg Bioforce AG 17/01/07<br />

Rectal ointment (50mg + 5mg)/g Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

31/08/05


EN<br />

774 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

260 Aesculan Suppository Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/08/05<br />

261 Aesculus compose krople Dolisos Laboratoires 31/12/08<br />

262 Aesculus Compositum Drops Heel GmbH 31/12/07<br />

263 Aesculus Pentarkan D krople Drops DHU-Arzneimittel GmbH &<br />

Co.KG<br />

264 Aesculus-Dagomed 11<br />

hemoroidy, z˙ylaki<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

19/03/06<br />

31/01/06<br />

265 Aesculus-Heel Drops Heel GmbH 31/12/07<br />

266 Aescuven Forte Hippocastani semen<br />

extractum siccum<br />

267 Aether Aethylicus pro Narcosi Liquid for inhalation<br />

anaesthesia<br />

Coated tablets 150 mg Julius Redel CESRA —<br />

Arzneimittelfabrik GmbH<br />

Pronit — Zakłady Tworzyw<br />

Sztucznych<br />

268 Aethoxysklerol 0,5 % Polidocanolum Solution for injection 5 mg/ml Chemische Fabrik Kreussler<br />

Co.GmgH<br />

269 Aethoxysklerol 1 % Polidocanolum Solution for injection 10 mg/ml Chemische Fabrik Kreussler<br />

Co.GmgH<br />

270 Aethoxysklerol 2 % Polidocanolum Solution for injection 20 mg/ml Chemische Fabrik Kreussler<br />

Co.GmgH<br />

271 Aethoxysklerol 3 % Polidocanolum Solution for injection 30 mg/ml Chemische Fabrik Kreussler<br />

Co.GmgH<br />

272 Aethoxysklerol 4 % Polidocanolum Solution for injection 40 mg/ml Chemische Fabrik Kreussler<br />

Co.GmgH<br />

273 Aethylum chloratum Ethylis chloridum Cutaneous spray Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’, Bydgoszcz<br />

274 Afecton Risperidonum Film-coated tablets 4 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

275 Afecton Risperidonum Film-coated tablets 3 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

276 Afecton Risperidonum Film-coated tablets 2 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

277 Afecton Risperidonum Film-coated tablets 1 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

278 Afibrozil Gemfibrozilum Film-coated tablets 450 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

279 Aflegan Ambroxolum Solution for<br />

subcutaneous,<br />

intramuscular,<br />

intravenous injection<br />

7.5 mg/ml Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

30/04/04<br />

31/01/06<br />

17/01/07<br />

17/01/07<br />

17/01/07<br />

17/01/07<br />

17/01/07<br />

31/01/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

23/02/06<br />

280 Afloderm Aclomethasonum Cream Belupo Ltd. 31/12/08<br />

281 Afloderm Aclomethasonum Ointment Belupo Ltd. 31/12/08<br />

282 Aflogistan Ointment Ziaja Ltd. — Zakład<br />

Produkcji Leków<br />

283 Aflogrip Paracetamolum +<br />

Phenylephrinum +<br />

Pheniraminum + Calcii<br />

carbonas + Acidum<br />

ascorbicum<br />

Powder praparat<br />

złoz˙ony<br />

31/12/08<br />

Aflofarm 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 775<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

284 Aflomag Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

285 Aflomag Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

286 Aflomag Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

287 Aflomag Aluminii hydroxydum +<br />

Magnesii hydroxydum<br />

Oral suspension (175mg +<br />

200mg)/5ml<br />

Oral suspension (175mg +<br />

200mg)/5ml<br />

Oral suspension (175mg +<br />

200mg)/5ml<br />

Buccal tablets 400 mg +<br />

400 mg<br />

Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

Aflofarm Fabryka Leków Sp.<br />

z o.o.<br />

288 Aflothenol Calcium pantothenicum Buccal tablets 120 mg Aflofarm Fabryka Leków Sp.<br />

z o.o.<br />

28/02/06<br />

28/02/06<br />

28/02/06<br />

28/02/06<br />

31/12/08<br />

289 Aflovit Witaminy Tablets Aflofarm 31/12/08<br />

290 Aflubin krople Richard Bittner 31/01/06<br />

291 Afobam Alprazolamum Tablets 0.25 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

292 Afobam Alprazolamum Tablets 0.5 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

293 Afonilum SR 125 Theophyllinum Prolonged release<br />

capsules<br />

294 Afonilum SR 250 Theophyllinum Prolonged release<br />

capsules<br />

295 Afonilum SR 375 Theophyllinum Prolonged release<br />

capsules<br />

296 Afonilum SR 500 Theophyllinum Prolonged release<br />

capsules, hard<br />

298 Afrin Oxymetazolini<br />

hydrochloridum<br />

297 Afrin Oxymetazolini<br />

hydrochloridum<br />

31/12/07<br />

31/12/07<br />

125 mg Abbott GmbH & Co KG 31/10/04<br />

250 mg Abbott GmbH & Co KG 31/10/04<br />

375 mg Abbott GmbH & Co KG 31/10/04<br />

500 mg Abbott GmbH & Co KG 31/08/04<br />

Eye drops, solution 0.25 mg/ml Schering-Plough Labo N.V. 31/08/04<br />

Nasal spray, solution 500 mcg/ml Schering-Plough Labo N.V. 31/05/04<br />

299 Agalin Lindanum Coutanous liquid 10 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/10/05<br />

300 Agapurin Pentoxifyllinum Coated tablets 100 mg Slovakofarma a.s. 30/06/04<br />

301 Agapurin Retard Pentoxifyllinum Prolonged release<br />

tablets<br />

302 Agapurin 600 Retard Pentoxifyllinum Prolonged release<br />

tablets<br />

400 mg Slovakofarma a.s. 30/06/04<br />

600 mg Slovakofarma a.s. 30/06/04<br />

303 Agen 10 Amlodipinum Tablets 10 mg Leciva a.s. 31/12/08<br />

304 Agen 5 Amlodipinum Tablets 5 mg Leciva a.s. 31/12/08<br />

305 Agenerase Amprenavirum Capsules, soft 150 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

306 Agenerase Amprenavirum Capsules, soft 50 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

307 Agenerase Amprenavirum Oral solution 15 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

308 Aggrastat Tirofibanum Concantrate for<br />

solution for<br />

intravenous infusion<br />

0.25 mg/ml Merck Sharp & Dohme Idea<br />

Inc.<br />

29/11/06<br />

29/11/06<br />

29/11/06<br />

30/04/05


EN<br />

776 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

309 Agiolax Herbal granules Madaus AG 18/07/05<br />

310 Agnucaston Drops Plantamed Arzneimittel<br />

GmbH<br />

311 Agnucaston, tabletki Plantamed Arzneimittel<br />

GmbH<br />

31/12/08<br />

31/12/08<br />

312 Agnusol Agni casti extractum Oral drops Phytopharm Kle˛ka S.A. 15/03/06<br />

313 Agramelk koncentrat Acidum lacticum Emulsion for veterinary<br />

use<br />

Agraria Pharma 31/12/08<br />

314 Agrimoniae herba Herb Z.K.Z. FLOS, Mokrsko 31/12/08<br />

315 AGRIPPAL — Inaktywowana<br />

Szczepionka Przeciw Grypie<br />

316 Agrisept Tabs Sól sodowa kwasu<br />

dihloroizocyjanuronowego<br />

Antygeny powierzchniowe wirusów grypy typu:A odpow. Beijing<br />

/262/95 (H1N1)B odpow. Beijing /184/93A odpow. Sydney /5/97<br />

(H3N3)<br />

Tablets for veterinary<br />

use<br />

Chiron Behring GmbH & Co,<br />

Oddział Szczepionek,<br />

Warszawa<br />

31/12/08<br />

Schering Plough 31/12/08<br />

317 AGROPYRON comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

318 AGROPYRON comp. granulki WALA-Heilmittel GmbH 19/03/05<br />

319 Agryflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

320 Agrypin Acidum ascorbicum +<br />

Rutosidum<br />

321 Agufem Agni casti fructus<br />

extractum siccum<br />

Film-coated tablets 300 mg +<br />

50 mg<br />

322 Airomir Salbutamolum Pressurised inhalation,<br />

suspension<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Film-coated tablets 4 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

100 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

323 Aivlosin FG 50 aivlozyna Powder for veterinary<br />

use<br />

324 Ajmafix D.I. Czynnik IX krzepnie˛cia Lyophilisate for<br />

intravenous use<br />

325 AJMAFIX D.I. Czynnik IX krzepnie˛cia Lyophilisate for<br />

intravenous use<br />

200 j.m. +<br />

5ml<br />

rozpuszczalnik<br />

+ zestaw do<br />

sporza˛dzania<br />

roztworu i<br />

podawania<br />

500 j.m.+10 ml<br />

rozpuszczalnik<br />

+ zestaw do<br />

sporza˛dzania<br />

roztworu i<br />

podawania<br />

15/01/06<br />

31/12/08<br />

27/09/06<br />

3M Medica 21/06/06<br />

Eco Animal Health Ltd. 31/12/08<br />

Instituto Sierova —<br />

Ccinogeno Italiano I.S.I. SpA<br />

Instituto Sierova —<br />

Ccinogeno Italiano I.S.I. SpA<br />

326 Ajona amin-o-med Toothpaste Dr Rudolf Liebe Nachf.<br />

GmbH<br />

327 Ajona Stomaticum Concentrate for<br />

toothpaste<br />

328 Akatus Agni casti fructus<br />

extractum siccum<br />

Dr Rudolf Liebe Nachf.<br />

GmbH<br />

Tablets 50 mg Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

28/02/04<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 777<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

329 Akindex Dextromethorphanum Syrup 20 mg/15 ml Urgo Laboratoires S.A. 31/12/08<br />

330 Akineton Biperidenum Solution for injection 5 mg/1 ml Abbott GmbH & Co KG 3/07/05<br />

331 Akineton Biperidenum Tablets 2 mg Abbott GmbH & Co KG 31/07/04<br />

332 Akineton SR 4 mg Biperidenum Prolonged release<br />

tablets<br />

333 Akipor Szczepionka przeciw<br />

chorobie Aujeszky'ego<br />

dla s´wiń<br />

334 Akipor 6.3 Szczepionka dla s´wiń<br />

przeciw chorobie<br />

Aujeszky'ego<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

4 mg Abbott GmbH & Co KG 10/05/06<br />

Rhone Merieux Laboratoire 31/12/08<br />

Merial SAS 21/05/04<br />

335 AKNE Liquid WALA-Heilmittel GmbH 24/05/07<br />

336 Akne — maseczka na skóre˛<br />

twarzy<br />

337 AKNE ka˛piel parowa do<br />

twarzy<br />

338 Aknefug Estradiolum +<br />

Hexachlorophenum<br />

Powder WALA-Heilmittel GmbH 24/05/07<br />

Liquid WALA-Heilmittel GmbH 24/04/07<br />

Cutaneous emulsion Dr August Wolff GmbH &<br />

Co.<br />

339 Aknefug® El Erythromycinum Coutanous liquid 10 mg/ml Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

340 Aknefug-Oxid 10 % Benzoylis peroxydum Gel 100 mg/g Dr August Wolff GmbH &<br />

Co.<br />

341 Aknefug-Oxid 3 % Benzoylis peroxydum Gel 30 mg/g (3 %) Dr August Wolff GmbH &<br />

Co.<br />

342 Aknefug-Oxid 5 % Benzoylis peroxydum Gel 50 mg/g Dr August Wolff GmbH &<br />

Co.<br />

343 AKNE-KAPSELN Kapsułki<br />

Akne<br />

345 Aknemycin Erythromycinum Coutanous liquid 20 mg/g Boots Healthcare<br />

International<br />

344 Aknemycin Erythromycinum Ointment 20 mg/g Boots Healthcare<br />

International<br />

346 Aknemycin Plus Erythromycinum +<br />

Tretinoinum<br />

Coutanous liquid Boots Healthcare<br />

International<br />

347 Akneroxid 5 Benzoylis peroxydum Gel 50 mg/g Boots Healthcare<br />

International<br />

348 Akneroxid L Benzoylis peroxydum Coutanous liquid 40 mg/g Boots Healthcare<br />

International<br />

349 Aknez˙el E Gel 40 mg<br />

erytromycyny ;<br />

0,25 mg<br />

tretinoiny<br />

31/07/04<br />

31/12/08<br />

30/09/05<br />

30/09/05<br />

30/09/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

350 Aknez˙el K 10 mg / 1 g Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

351 Aksoderm Retinolum Ointment 400 j.m./g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

352 Aksoderm Forte Ointment Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

31/07/04<br />

31/07/04<br />

31/07/05<br />

16/04/06<br />

16/05/07<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

31/12/08


EN<br />

778 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

353 Aktis Metamizolum Effervescent tablets 500 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

354 Aktren Ibuprofenum Effervescent granules 200 mg Bayer AG 30/06/04<br />

355 Aktren Ibuprofenum Film-coated tablets 200 mg Bayer AG 30/06/04<br />

356 Akutol Nitrofuralum Cutaneous spray Aveflor a.s. 26/04/06<br />

357 Alantan Allantoinum Ointment 20 mg/g Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

358 Alantan Allantoinum + Acidum<br />

boricum + Zinci oxydum<br />

359 Alantan-Plus Allantoinum +<br />

Dexpanthenolum<br />

360 Alantan-Plus Allantoinum +<br />

Dexpanthenolum<br />

361 Alantavit Allantoinum +<br />

Colecalciferolum +<br />

Retinolum<br />

Medicated powder Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

Cream Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

Ointment Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

Ointment (10mg +<br />

500 j.m. +<br />

1000j.m.)/g<br />

Coel s.c.- Laboratorium<br />

Farmaceutyczne Wytwórnia<br />

Euceryny<br />

362 Alax Preparat ziołowy Coated tablets Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

363 Albadry Plus Penicylina G<br />

prokainowa,<br />

Nowobiocyna<br />

Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

31/01/06<br />

31/01/06<br />

30/10/05<br />

30/10/05<br />

31/01/06<br />

31/08/05<br />

Pharmacia 31/12/08<br />

364 Albarel Rilmenidinum Tablets 1 mg Egis Pharmaceuticals Ltd. 27/04/05<br />

365 Albentel Albendazolum Oral suspension 400 mg/20 ml Medana Pharma TERPOL<br />

Group S.A.<br />

31/12/08<br />

366 Albicansan D5 iniekcje Sanum-Kehlbeck 31/12/05<br />

367 Albicansan D5 krople Sanum-Kehlbeck 31/12/05<br />

368 Albipen LA Ampicillinum Suspension for veterinary<br />

use<br />

Intervet 4/05/04<br />

369 Albothyl Policresulenum Pessary 90 mg Alatana Pharma AG 30/06/04<br />

370 Albumin 20 % Human Salzarm Albuminum Solution for<br />

intravenous infusion<br />

371 Albumin 5 % Human Albuminum Solution for<br />

intravenous infusion<br />

372 Albumina ludzka 5 % Albuminum Solution for<br />

intravenous infusion<br />

373 Albumina ludzka 5 % do<br />

stosowania doz˙ylnego<br />

Albuminum Solution for<br />

intravenous infusion<br />

374 Albumina ludzka 20 % Albuminum Solution for<br />

intravenous infusion<br />

200 mg/ml Octapharma Pharmazeutika<br />

Produktionsges m.b.H<br />

50 mg/ml Octapharma Pharmazeutika<br />

Produktionsges m.b.H<br />

31/07/04<br />

31/07/04<br />

50 mg/ml ZLB Bioplasma AG 31/05/05<br />

50 mg/ml Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

31/01/06<br />

200 mg/ml ZLB Bioplasma AG 31/05/05<br />

375 Albumoheel S Tablets Heel GmbH 31/12/08<br />

376 Alcaine Proxymetacainum Eye drops, solution 5 mg/ml Alcon Couvreur N.V. 30/04/05<br />

377 Alcep Allii cepae extractum<br />

fluidum<br />

Syrup 949 mg/5ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 779<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

378 Alcepalan Allii cepae extractum +<br />

Heparinum<br />

379 Alchinal Allii sativi extractum<br />

siccum, Echinaceae<br />

purpureae herbae<br />

extractum siccum<br />

Gel (50mg +<br />

50j.m.)/g<br />

Powder for oral<br />

suspension<br />

Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

380 Aldactone Kalii canrenoas Solution for injection 20 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

30/06/06<br />

31/12/08<br />

31/05/04<br />

381 Aldan Amlodipinum Tablets 5 mg Polfarmex S.A. 31/12/08<br />

382 Aldan Amlodipinum Tablets 10 mg Polfarmex S.A. 31/12/08<br />

383 Aldara 5 % Krem Imiquimodum Cream 50 mg/g 3M Medica 31/05/05<br />

384 Aldecin inhaler Beclometasonum Pressurised inhalation,<br />

suspension<br />

50 mcg/dawke˛<br />

inhalacyjna˛<br />

Schering- Plough Labo N.V. 31/05/04<br />

385 Aldizem Diltiazemum Tablets 60 mg Alkaloid 31/07/04<br />

386 Alefos Acidum alendronicum Tablets 70 mg Blau — Farma Sp. z o.o. 31/12/08<br />

387 Alenato Acidum alendronicum Tablets 10 mg ICN Polfa Rzeszów S.A. 15/11/06<br />

388 Alenato Acidum alendronicum Tablets 5 mg ICN Polfa Rzeszów S.A. 15/11/06<br />

389 Alendronate Acidum alendronicum Tablets 5 mg i 10 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

390 Alendronate Sodium Acidum alendronicum Oral capsules 13,05 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

391 Aleras Cetirizinum Film-coated tablets 10 mg Boehringer Ingelheim<br />

International GmbH<br />

392 Alergeny Diagnostyczne Do<br />

Testów Prowokacyjnych<br />

393 Alergeny Diagnostyczne Do<br />

Testów Punktowych<br />

394 Alergeny diagnostyczne do<br />

testów punktowych<br />

395 Alergeny Diagnostyczne Do<br />

Testów S´ ródskórnych<br />

Wycia˛gi alergenowe Solution Haarlems Alergenen<br />

Laboratorium B.V.<br />

Wycia˛gi alergenowe Solution Haarlems Alergenen<br />

Laboratorium B.V.<br />

Wycia˛gi alergenowe Solution for<br />

subcutanous injection<br />

Solution Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

Haarlems Alergenen<br />

Laboratorium B.V.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/04/04<br />

30/10/05<br />

31/12/08<br />

396 Alergie HomeoPorady Laboratoires BOIRON 4/07/07<br />

397 Alergoftal Antazolinum +<br />

Naphazolinum<br />

Eye drops Alcon Cusi, S.A. 31/07/04<br />

398 Aleric Loratadinum Syrup 1mg /ml US Pharmacia 24/05/06<br />

399 Aleric Loratadinum Tablets 10 mg US Pharmacia Sp. z o.o. 24/05/06<br />

400 Alerid Cetirizinum Film-coated tablets 10 mg Medial Polska Sp. z o.o. 31/12/08<br />

401 Alerid Cetirizinum Film-coated tablets 10 mg Cipla Ltd. 31/12/08<br />

402 Alerzina Cetirizinum Tablets 10 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

403 Alestin Ebastinum Film-coated tablets 10 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/12/08<br />

31/12/08<br />

404 Aletris-Heel Tablets Heel GmbH 31/07/05


EN<br />

780 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

405 Aleve Naproxenum Film-coated tablets 220 mg Roche Consumer Health Ltd 31/12/08<br />

407 Alexan Cytarabinum Solution for injection 20 mg/ml Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

408 Alexan Cytarabinum Solution for injection 20 mg/ml Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

406 Alexan Cytarabinum Solution for<br />

intravenous infusion<br />

50 mg/ml Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

409 Alfa- Tocopherol Acetate Tocopherolum Capsules 100 mg Chemiczno —<br />

Farmaceutyczna S.A. ICN<br />

OKTYABR Sankt —<br />

Petersburg<br />

410 Alfadiol, Alphacalcidolum Alfacalcidolum Capsules 0.25 mcg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

411 Alfadiol, Alphacalcidolum Alfacalcidolum Capsules 1 mcg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

412 Alfaferone Interferonum alfa natural Solution for<br />

subcutaneous and<br />

intramuscular<br />

injection or for<br />

infusion<br />

413 Alfaferone Solution for<br />

subcutaneous and<br />

intramuscular<br />

injection or for<br />

infusion<br />

414 Alfaferone Solution for<br />

subcutaneous and<br />

intramuscular<br />

injection or for<br />

infusion<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

31/12/08<br />

31/12/05<br />

31/12/05<br />

1e+006 j.m/ml Alfa Wassermann S.p.A. 23/11/05<br />

3e+006 j.m/ml Alfa Wassermann S.p.A. 23/11/05<br />

6e+006 j.m/ml Alfa Wassermann S.p.A. 23/11/05<br />

415 Alfakalcydol Alfacalcidolum Capsules, soft 0.25 mcg Instytut Farmaceutyczny 12/10/05<br />

416 Alfakalcydol Alfacalcidolum Capsules, soft 1 mcg Instytut Farmaceutyczny 12/10/05<br />

417 Alfan Paracetamolum Capsules, soft 500 mg US Pharmacia 31/12/08<br />

418 Algesal Diethylamini salicylas +<br />

Myrtecainum<br />

Cream (100mg +<br />

10mg)/g<br />

Solvay Pharma — Suresnes<br />

Cedex<br />

31/07/04<br />

419 Alginete Tablets Krka d.d., Novo mesto 31/12/06<br />

420 Algophytum Capsules Herbaxat Laboratoires Z.I. 31/12/08<br />

421 Algorhin Preparat złoz˙ony Inhalation vapour,<br />

solution<br />

422 Alifar Allii sativi bulbus<br />

extractum fluidum<br />

423 Alimentum Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

424 Aliovital Alli ativi bulbus<br />

maceratio oleosa<br />

425 Aliovital Forte Allii sativi bulbus<br />

maceratio oleosa<br />

Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

Oral drops 414 mg/ml Zakład Produkcyjno-<br />

Usługowy FARKO s.c.,<br />

Mrocza<br />

Liquid Ross Products Division<br />

Abbott laboratories<br />

30/04/05<br />

31/12/08<br />

11/10/06<br />

Capsules, soft 270 mg Agropharm S.A. 10/05/06<br />

Capsules, soft 510 mg Agropharm S.A. 25/10/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 781<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

426 Alistim Simvastatinum Film-coated tablets 10 mg MEPHA Ltd. 31/12/08<br />

427 Alistim Simvastatinum Film-coated tablets 20 mg MEPHA Ltd. 31/12/08<br />

428 Alistim Simvastatinum Film-coated tablets 40 mg MEPHA Ltd. 31/12/08<br />

429 Alitol Capsules 270 mg Krka d.d., Novo mesto 29/02/04<br />

430 Alitraq Preparat odz˙ywczy Powder Ross Products Division-<br />

Abbott Laboratories<br />

431 Alka-Prim Acidum acetylsalicylicum<br />

+ Glycinum<br />

Effervescent tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/09/07<br />

30/10/05<br />

432 Alka-Seltzer Acidum acetylsalicylicum Effervescent tablets 0.324 g Bayer AG 31/07/04<br />

433 Alkeran Melphalanum Film-coated tablets 2 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

434 Alkeran Melphalanum Film-coated tablets 5 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

435 Alkohol etylowy 70 % skaz˙ony<br />

chlorheksydyna˛ 0.18 %<br />

31/07/04<br />

31/07/04<br />

Liquid Maga-Herba s.c., Legionowo 19/04/07<br />

436 Alkohol fenyloetylowy Pharma Cosmetic, Kraków 30/09/05<br />

437 Alkohol izopropylowy Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

438 Allergo — Comod Timololum Eye drops 20 mg/ml Ursapharm Arzneimittel<br />

GmbH<br />

439 Allergo Comod Natrii cromoglicas Nasal spray, solution 20 mg/ml Ursapharm Arzneimittel<br />

GmbH<br />

440 Allergocrom Acidum cromoglicicum Eye drops 20 mg/ml Ursapharm Arzneimittel<br />

GmbH& CoKG<br />

441 Allergocrom Natrii cromoglicas Nasal spray, solution 20 mg/ml Ursapharm Arzneimittel<br />

GmbH<br />

30/09/05<br />

31/12/08<br />

31/12/08<br />

5/07/06<br />

5/07/06<br />

443 Allergodil Azelastinum Eye drops Asta Medica AG 31/12/08<br />

444 Allergodil Azelastinum Film-coated tablets 2 mg Asta Medica AG 31/12/08<br />

442 Allergodil Azelastinum Nasal spray 0.1 % Asta Medica AG 31/12/08<br />

445 Allergovit Alergeny pyłków ros´lin Suspension for<br />

subcutaneous<br />

injection<br />

446 Allergovit Alergeny pyłków ros´lin Suspension for<br />

subcutaneous<br />

injection<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

449 Allertec Cetirizinum Film-coated tablets 10 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

447 Allertec Cetirizinum Oral drops 10 mg / ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

448 Allertec Cetirizinum Syrup 5 mg/5 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

450 Allfo 20 Albuminum humanum Solution for<br />

intravenous infusion<br />

451 Allfo 4 Albuminum humanum Solution for<br />

intravenous infusion<br />

fiolki 10 ml;<br />

butelki 100 ml<br />

40 mg/ml;<br />

fiolki 50 ml;<br />

butelki 500 ml<br />

31/12/08<br />

31/12/08<br />

28/02/06<br />

23/11/05<br />

23/11/05<br />

CSL Limited 31/12/08<br />

CSL Limited 31/12/08


EN<br />

782 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

452 Allicin Agropharm S.A. 31/12/08<br />

453 Allimel, miód czosnkowy Farmaceutyczne<br />

Przedsie˛biorstwo Prod. —<br />

Anal. — Handl. ‘PROLAB’<br />

s.c., Nakło<br />

454 Alliofil Allii sativi bulbus +<br />

Urticae folium<br />

Film-coated tablets 200mg +<br />

53,5mg<br />

Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

455 Alliogal Capsules, soft 350 mg Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

456 Alliogel Allii sativi extractum +<br />

Allantoinum +<br />

Troxerutinum<br />

457 Alliol Olejowy wycia˛g z<br />

czosnku<br />

Gel (100mg +<br />

10mg +<br />

20mg)/g<br />

Suspension for veterinary<br />

use<br />

Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

31/12/08<br />

31/08/05<br />

31/07/06<br />

30/10/05<br />

Biowet Puławy 31/12/08<br />

458 Alliomint Allii sativi bulbus Tablets 300 mg Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

459 Alliorut Preparat złoz˙ony Film-coated tablets Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

460 Allithera Capsules BIOGAL Pharmaceutical<br />

Works Ltd<br />

461 Allochol ONP Borszczagowski Zakład<br />

Chemiczno Farmaceutyczny,<br />

Ukraina<br />

462 Alloferin Alcuronii chloridum Solution for<br />

intravenous injection<br />

31/12/08<br />

28/10/06<br />

31/12/08<br />

31/12/08<br />

5 mg/ml ICN Polfa Rzeszów S.A. 31/01/05<br />

463 Allopurinol Allopurinolum Tablets 100 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

31/05/06<br />

464 Alloratio 100 Allopurinolum Tablets 100 mg ratiopharm GmbH 30/04/04<br />

465 Allupol Allopurinolum Tablets 100 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

466 Almirid Dihydroergocryptini<br />

mesylas<br />

467 Aloe — Derm N Aloe arborescens,<br />

Neomycini sulphas<br />

30/11/05<br />

Tablets 20 mg Poli Industria Chimica S.p.A 14/12/05<br />

Ointment 30 mg/g +<br />

5 mg/g<br />

Zakłady Farmaceutyczno —<br />

Aerozolowe ‘UNIA’<br />

Spółdzielnia Pracy<br />

31/12/08<br />

468 Aloe compose krople Dolisos Laboratoires 31/12/08<br />

469 Aloe leaves extract Amp. Polypharm S.A. 31/12/08<br />

470 Aloe Vera Tea Tree Liniment Ointment Australian Aloe Ltd. 31/07/04<br />

471 Aloe-Dagomed 12 biegunki DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

472 Aloe-derm Aloe arborescens folium<br />

extractum siccum<br />

Ointment 30 mg/g Zakłady Farmaceutyczno —<br />

Aerozolowe ‘UNIA’<br />

Spółdzielnia Pracy<br />

31/01/06<br />

31/12/08<br />

473 Alomide Lodoxamidum Eye drops 1 mg/ml Alcon Couvreur N.V. 30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 783<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

474 Alopevac Inaktywowana<br />

szczepionka dla lisów<br />

hodowlanych przeciw<br />

grzybicy skórnej<br />

Suspension for veterinary<br />

use<br />

475 Alphacalcidolum Alfacalcidolum Capsules, soft 0,001 mg ;<br />

0,00025 mg<br />

Biowet Puławy 24/01/07<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/08<br />

476 Alphagan Brimonidinum Eye drops, solution 2 mg/ml Allergan Inc. 25/01/06<br />

477 Alpicort Acidum salicylicum +<br />

Prednisolonum<br />

478 Alpicort E Acidum salicylicum +<br />

Estradiolum +<br />

Prednisolonum<br />

Coutanous liquid Dr August Wolff GmbH &<br />

Co.<br />

Coutanous liquid Dr August Wolff GmbH &<br />

Co.<br />

479 Alplucine Pig Premix Jozomycyna Premix for veterinary<br />

use<br />

480 Alplucine Premix Jozomycyna Premix for veterinary<br />

use<br />

481 Alplucine SP Jozomycyna Powder for veterinary<br />

use<br />

31/07/04<br />

31/07/04<br />

Virbac 14/03/05<br />

Virbac 31/12/08<br />

Virbac 31/12/08<br />

482 Alprax Alprazolamum Tablets 0,5 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

483 Alprax Alprazolamum Tablets 1 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

484 Alprax Alprazolamum Tablets 2 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

485 Alprazomerck 0,25 Alprazolamum Tablets 0.25 mg Generics (UK) Limited 6/12/06<br />

486 Alprazomerck 0,5 Alprazolamum Tablets 0.5 mg Generics (UK) Limited 6/12/06<br />

487 Alprazomerck 1,0 Alprazolamum Tablets 1 mg Generics (UK) Limited 6/12/06<br />

488 Alprostapint 20 Alprostadilum Concentrate for<br />

solution for infusion<br />

489 Alprostapint 500 Alprostadilum Concentrate for<br />

solution for infusion<br />

20 mcg/ 1 ml Pint Pharma GmbH 24/08/05<br />

500 mcg/ 1 ml Pint Pharma GmbH 24/08/05<br />

490 Alprox Alprazolamum Tablets 0.5 mg Orion Corporation 30/11/04<br />

491 Alprox Alprazolamum Tablets 1 mg Orion Corporation 30/11/04<br />

492 Alpurin Allopurinol Tablets 100 mg Polfarmex S.A. 31/12/08<br />

494 Altacet Aluminii acetotartras Gel 10 mg/g EMO Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych doc dr hab..<br />

Farm. Michał Oginski<br />

493 Altacet Aluminii acetotartras Tablets 1 g ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

495 Altagel Aluminium<br />

acetotatratum<br />

Gel 10mg / 1 g ZIAJA Ltd. Zakład<br />

Produkcyjny Gdańsk<br />

496 Altalex Lek Pharmaceutical &<br />

Chemical Company d.d.<br />

497 Althagem Althaeae radix Syrup 387 mg/5ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

30/09/05<br />

30/09/05<br />

31/12/08<br />

31/12/08<br />

31/07/05


EN<br />

784 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

498 Althamel Althaeae radix Medicated honey 212 mg/5 ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

499 Altix Aluminii acetotartras Cream 10 mg/g Herba Studio Ms´cisz i<br />

Wspólnicy Spółka Jawna<br />

500 Altix Aluminii acetotartras Cream 7.5 mg/g Herba Studio Ms´cisz i<br />

Wspólnicy Spółka Jawna<br />

501 Altra Frangulae cortex<br />

extractum siccum +<br />

Frangulae cortex pulvis<br />

Coated tablets 120mg +<br />

100mg<br />

Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

9/08/06<br />

23/11/05<br />

23/11/05<br />

31/08/05<br />

504 Altramet Cimetidinum Film-coated tablets 200 mg Lek Pharmaceuticals d.d. 31/07/04<br />

505 Altramet Cimetidinum Film-coated tablets 200 mg Lek Polska Sp. z o.o. 31/01/06<br />

502 Altramet Cimetidinum Solution for injection 100 mg/ml Lek Pharmaceuticals d.d. 31/07/04<br />

503 Altramet Cimetidinum Solution for injection 100 mg/ml Lek Polska Sp. z o.o. 31/01/06<br />

506 Alugastrin Dichydroxyaluminii<br />

natrii carbonas<br />

507 Alugastrin Dichydroxyaluminii<br />

natrii carbonas<br />

509 Alumag Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

508 Alumag Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

Buccal tablet 340 mg Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

Oral suspension 340mg/5 ml Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

Oral suspension (23mg w<br />

przeliczeniu na<br />

tlenek glinu +<br />

40,77mg)/ml<br />

Tablets 200mg +<br />

200mg<br />

Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

510 Alumina-Dagomed 19 zaparcia DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

512 Alusal Aluminii hydroxidum Buccal tablet 500mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

511 Alusal Aluminii hydroxidum Tablets 500mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

513 Alustin Aluminii chloridum<br />

hexahydricum +<br />

Oxyquinolinum<br />

514 Alutard SQ Alergeny jadów<br />

błonoskrzydłych<br />

Liquid (200mg +<br />

1mg)/g<br />

Suspension for<br />

subcutaneous<br />

injection<br />

515 Alutard SQ Alergeny pyłków ros´lin Suspension for<br />

subcutaneous<br />

injection<br />

516 Alutard SQ Alergeny roztoczy kurzu<br />

domowego<br />

517 Alutard SQ Alergeny róz˙ne —<br />

mieszanina<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

518 Alutard SQ Alergeny siers´ci zwierza˛t Suspension for<br />

subcutaneous<br />

injection<br />

519 Alveofact Surfactantum Endotracheopulmonary<br />

instillation, solution<br />

Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

28/02/06<br />

28/02/06<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

30/10/05<br />

Alk-Abello A/S 30/06/05<br />

Alk-Abello A/S 30/06/05<br />

Alk-Abello A/S 30/06/05<br />

Alk-Abello A/S 30/06/05<br />

Alk-Abello A/S 30/06/05<br />

50 mg/1,2 ml Boehringer Ingelheim<br />

International GmbH<br />

31/05/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 785<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

520 Alvia zaparcia, syrop DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

14/11/05<br />

522 Alvityl Film-coated tablets Solvay Pharma Laboratoire 30/01/05<br />

521 Alvityl Syrup Solvay Pharma — Suresnes<br />

Cedex<br />

31/07/04<br />

523 Alvogyl Lidocainum, Eugenol Gingival paste Septodont 31/12/06<br />

524 Alvogyl Dental paste Septodont 31/12/06<br />

525 Alyostal Alergeny diagnostyczne Solution Stallergenes S.A. 30/06/05<br />

527 Amantix Amantadinum Film-coated tablets 100 mg Merz & Co. GmbH 31/12/08<br />

526 Amantix Amantadinum Solution for<br />

intravenous infusion<br />

200 mg/500ml Merz & Co. GmbH 31/12/08<br />

528 Amarosal Syrup Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/12/08<br />

529 Amarosal ‘d’, Syrup Herbapol, Wrocław 31/12/08<br />

530 Amarum Preparat ziołowy Herbal tea Naturwaren OHG Dr Peter<br />

Theiss<br />

531 Amaryl 1 Glimepiridum Tablets 1 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

532 Amaryl 2 Glimepiridum Tablets 2 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

533 Amaryl 3 Glimepiridum Tablets 3 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

534 Amaryl 4 Glimepiridum Tablets 4 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

535 Amaryl 6 Glimepiridum Tablets 6 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

536 AmBisome Amphotericinum B Powder for solution<br />

for intravenous<br />

infusion<br />

50 mg Gilead Sciences International<br />

Ltd.<br />

31/05/04<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/08<br />

537 Ambix Acne Treatment Cream Benzoylis peroxydum Cream 13.5 mg/g Kato Laboratories Inc. 31/07/04<br />

538 Ambro, Ambrohexal Ambroxolum Effervescent tablets 30 mg Hexal AG 30/04/05<br />

539 Ambrogem Ambroxolum Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

540 AMBROGEM Forte Ambroxolum Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

31/12/08<br />

31/12/08<br />

542 Ambrohexal Ambroxolum Oral solution 7.5 mg/ml Hexal AG 31/03/05<br />

541 Ambrohexal Ambroxolum Solution for<br />

subcutaneous,<br />

intramuscular,<br />

intravenous injection<br />

7.5 mg/ml Hexal AG 31/03/05<br />

543 Ambrohexal Ambroxolum Tablets 30 mg Hexal AG 31/03/05<br />

544 Ambrohexal Retard Ambroxolum Prolonged release<br />

capsules<br />

75 µg HEXAL AG 31/12/08<br />

545 Ambrohexal S Ambroxolum Oral solution 15 mg/ml Hexal AG 14/02/07


EN<br />

786 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

546 Ambroksol Ambroxolum Syrup 15 mg/5 ml Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

547 Ambroksol Ambroxolum Syrup 30 mg/5 ml Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

28/02/06<br />

18/07/05<br />

548 Ambroksol Ambroxolum Tablets 30 mg Sanofi — Biocom Sp. z o.o. 28/02/06<br />

549 Ambroksol Ambroxolum Tablets 30 mg Byk Mazowia Sp. z o.o.,<br />

Łyszkowice<br />

28/02/06<br />

550 Ambrosan Ambroxolum Tablets 30 mg PRO. MED. CS. Praha a.s. 27/06/07<br />

551 Ambrosol Ambroxolum Drops 7.5 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

552 Ambrosol Ambroxolum Syrup 15 mg/5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

553 Ambrosol Ambroxolum Syrup 30 mg/5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

30/04/05<br />

30/04/05<br />

554 Ambroxol Ambroxolum Syrup 15 mg/5ml Polfarmex S.A 30/06/05<br />

555 Ambroxol Ambroxolum Syrup 30 mg/5ml Polfarmex S.A 30/06/05<br />

556 Ambroxol Hydrochloride Ambroxolum Effervescent tablets 60 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

557 Ambroxol, Anavix Ambroxolum Syrup for adult 30 mg/5 ml Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

558 Ambroxol, Anavix Ambroxolum Syrup for children 15 mg/5 ml Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

559 Ambroxol-ratiopharm 15 Ambroxolum Solution for injection 7.5 mg/ml ratiopharm GmbH 30/04/04<br />

560 Amerscan Dmsa Agen Acidum<br />

dimercaptosuccinicum<br />

(DMSA)<br />

561 Amerscan Hepatate II Agent Preparat<br />

radiofarmaceutyczny<br />

562 Amerscan Pentetate II Agent Calcium trisodium<br />

pentetate<br />

563 Amerscan Stannous Agent Preparat<br />

radiofarmaceutyczny<br />

564 Amerscan Tm Medronate II<br />

Agent<br />

Preparat<br />

radiofarmaceutyczny<br />

565 Amertec II Natrii pertechnetatis<br />

(99mTc) fissione formati<br />

Radiopharmaceutical<br />

kit<br />

Radiopharmaceutical<br />

kit<br />

Radiopharmaceutical<br />

kit<br />

Radiopharmaceutical<br />

kit<br />

Nycomed Amersham plc 31/12/08<br />

Nycomed Amersham plc 31/12/08<br />

Nycomed Imaging AS 31/12/08<br />

Nycomed Amersham plc 31/12/08<br />

Set Nycomed Amersham plc 31/12/08<br />

Solution Nycomed Amersham plc 31/12/08<br />

566 Amertil Cetirizinum Film-coated tablets 10 mg P.P.H.U. Biofarm Sp. z o.o. 30/11/05<br />

567 Amervac PRRS/A3 Z˙ywa szczepionka dla<br />

s´wiń przeciwko<br />

zespołowi rozrodczo<br />

oddechowemu s´wiń<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Laboratorios Hipra S.A. 18/09/07<br />

568 Amfobase Cutaneous emulsion Herba Studio Ms´cisz i<br />

Wspólnicy Spółka Jawna<br />

569 Amiginko Ginkgo bilobae folium<br />

extractum siccum<br />

6/06/07<br />

Syrup 40mg/5 ml Amilek Sp. z o.o. 31/12/08<br />

570 Amikin Amikacinum Solution for injection 100 mg/2 ml Bristol-Myers Squibb S.p.A. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 787<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

571 Amikin Amikacinum Solution for<br />

intramuscular and<br />

intravenous injection<br />

572 Amikin Amikacinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

573 Amikin Amikacinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

250 mg/ml Bristol-Myers Squibb S.p.A. 30/04/04<br />

125 mg/ml Bristol-Myers Squibb S.p.A. 30/04/04<br />

250 mg/ml Bristol-Myers Squibb S.p.A. 30/04/04<br />

574 AMINI VISNAGA Suppository 2 g WALA-Heilmittel GmbH 24/05/07<br />

575 Aminofenazon Margo Corporation,<br />

Warszawa<br />

31/12/08<br />

576 Aminofenazon Polfa Pabianice 31/12/08<br />

577 Aminofilina A.C.E.F., Włochy 31/12/08<br />

578 Aminofilina Farm-Impex s.j., Gliwice 31/12/08<br />

579 Aminofilina Pharma Cosmetic, Kraków 31/12/08<br />

580 Aminofilina Pharma Zentrale 31/12/08<br />

581 Aminofilina PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

582 Aminofilina -czopki<br />

pediatryczne<br />

583 Aminofilina -czopki<br />

pediatryczne<br />

31/12/08<br />

Aminophyllinum Suppository 100 mg Farmjug Sp. z o.o. 31/01/06<br />

Aminophyllinum Suppository 50 mg Farmjug Sp. z o.o. 31/01/06<br />

584 Aminoglutetimid Aminoglutethimidum Tablets 250 mg VIPHARM S.A. 31/12/05<br />

585 Aminomel 10 E Solution for<br />

intravenous infusion<br />

586 Aminomel 12,5 E Solution for<br />

intravenous infusion<br />

587 Aminomel Nephro Solution for<br />

intravenous infusion<br />

588 Aminomix 1 Preparat złoz˙ony Solution for<br />

intravenous infusion<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

589 Aminophyllinum Aminophyllinum Oral drops, solution 240 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

590 Aminophyllinum Aminophyllinum Solution for<br />

intramuscular<br />

injection<br />

591 Aminophyllinum Aminophyllinum Solution for<br />

intravenous injection<br />

592 Aminophyllinum Aminophyllinum Solution for<br />

intravenous injection<br />

593 Aminophyllinum prolongatum Aminophyllinum Prolonged release<br />

tablets<br />

250 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/07/04<br />

31/07/04<br />

31/07/04<br />

3/06/06<br />

30/11/05<br />

30/11/05<br />

25 mg/ml Lek Pharmaceuticals d.d. 31/05/04<br />

25 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

350 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/11/05<br />

31/01/06


EN<br />

788 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

594 Aminophyllinum Retard Aminophyllinum Prolonged release<br />

tablets<br />

595 Aminoplasmal 10 % E Solution for<br />

intravenous infusion<br />

596 Aminoplasmal 15 % Solution for<br />

intravenous infusion<br />

597 Aminoplasmal 15 % E Solution for<br />

intravenous infusion<br />

598 Aminoplasmal Hepa 10 % Solution for<br />

intravenous infusion<br />

599 Aminosteril KE 10 % bez<br />

we˛glowodanów z elektrolitami<br />

Solution for<br />

intravenous infusion<br />

600 Aminosteril N-Hepa 8 % Solution for<br />

intravenous infusion<br />

601 Aminoven Infant 10 % Solution for<br />

intravenous infusion<br />

602 Aminoven Infant 6 % Solution for<br />

intravenous infusion<br />

350 mg Lek Pharmaceuticals d.d. 30/06/04<br />

B. Braun Melsungen AG 31/07/04<br />

B. Braun Melsungen AG 12/03/06<br />

B. Braun Melsungen AG 12/03/06<br />

B. Braun Melsungen AG 30/11/04<br />

Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

3/06/06<br />

31/07/04<br />

30/04/05<br />

3/06/06<br />

603 Amiokordin Amiodaronum Solution for injection 50 mg/ml Krka d.d., Novo mesto 31/07/04<br />

604 Amiokordin Amiodaronum Tablets 200 mg Krka d.d., Novo mesto 31/01/06<br />

605 Amiosten Acidum alendronicum Tablets 5 mg Amilek Sp. z o.o. 31/12/08<br />

606 Amiosten Acidum alendronicum Tablets 10 mg Amilek Sp. z o.o. 31/12/08<br />

607 Amipar Paracetamolum Tablets 500 mg Amilek Sp. z o.o 31/12/08<br />

608 Amitriptylinum Amitriptylinum Coated tablets 10 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

609 Amitriptylinum Amitriptylinum Coated tablets 25 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

610 Amitriptylinum Amitriptylinum Film-coated tablets 10 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

611 Amitriptylinum Amitriptylinum Film-coated tablets 25 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

612 Amitriptylinum 2,5 % Amitriptylinum Solution for injection 25 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

613 Amitropil Piracetamum Syrup 200 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

615 Amizepin Carbamazepinum Oral suspension 100 mg/5ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

614 Amizepin Carbamazepinum Tablets 200 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

616 Amizepin prolongatum Carbamazepinum Prolonged release<br />

tablets<br />

617 Amizepin prolongatum Carbamazepinum Prolonged release<br />

tablets<br />

200 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

400 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/11/05<br />

31/05/06<br />

31/12/07<br />

30/10/05<br />

6/07/05<br />

6/07/05<br />

618 Amlocor 10 Amlodipinum Tablets 10 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

619 Amlocor 2,5 Amlodipinum Tablets 2,5 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

620 Amlocor 5 Amlodipinum Tablets 5 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

621 Amlocor 7,5 Amlodipinum Tablets 7,5 mg HEXAL Polska Sp. z o.o. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 789<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

622 Amlodipine Amlodipinum Tablets 5 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/12/08<br />

623 Amlodipinum Amlodipinum Tablets 10 mg Lek Pharmaceuticals d.d. 30/01/05<br />

624 Amlodipinum Amlodipinum Tablets 5 mg Lek Pharmaceuticals d.d. 30/01/05<br />

625 Amlodypine Amlodipinum Tablets 10 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

626 Amlonor Amlodipinum Tablets 5 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

627 Amlonor Amlodipinum Tablets 10 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

628 Amlopin Amlodipinum Tablets 10 mg Lek Polska Sp. z o.o. 30/01/05<br />

629 Amlopin Amlodipinum Tablets 5 mg Lek Polska Sp. z o.o. 30/01/05<br />

630 Amlopol Amlodipinum Tablets 5 mg Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

631 Amlopol Amlodipinum Tablets 10 mg Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

31/12/08<br />

632 Amlopres — 10 Amlodipinum Tablets 10 mg Cipla Ltd. 31/12/08<br />

633 Amlopres — 5 Amlodipinum Tablets 5 mg Cipla Ltd. 31/12/08<br />

634 Amloratio 10 Amlodipinum Tablets 10 mg ratiopharm GmbH 31/12/08<br />

635 Amloratio 5 Amlodipinum Tablets 5 mg ratiopharm GmbH 31/12/08<br />

636 Amlotens Amlodipinum Tablets 5 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

637 Amlotens Amlodipinum Tablets 10 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/12/08<br />

31/12/08<br />

638 Amlovasc Amlodipinum Tablets 5 mg Filofarm Bydgoszcz 31/12/08<br />

639 Amlovasc Amlodipinum Tablets 10 mg Filofarm Bydgoszcz 31/12/08<br />

640 Amlozek Amlodipinum Tablets 10 mg Adamed Sp. z o.o. 31/12/08<br />

641 Amlozek Amlodipinum Tablets 5 mg Adamed Sp. z o.o. 31/12/08<br />

642 Amnowy chlorek Pharma Cosmetic, Kraków 31/12/08<br />

647 Amoksiklav Acidum clavulanicum +<br />

Amoxicillinum<br />

648 Amoksiklav Acidum clavulanicum +<br />

Amoxicillinum<br />

649 Amoksiklav Acidum clavulanicum +<br />

Amoxicillinum<br />

645 Amoksiklav Acidum clavulanicum +<br />

Amoxicillinum<br />

646 Amoksiklav Acidum clavulanicum +<br />

Amoxicillinum<br />

643 Amoksiklav Acidum clavulanicum +<br />

Amoxicillinum<br />

Film-coated tablets 1000 mg Lek Pharmaceuticals d.d. 31/05/04<br />

Film-coated tablets 375 mg Lek Pharmaceuticals d.d. 30/04/04<br />

Film-coated tablets 625 mg Lek Pharmaceuticals d.d. 30/04/04<br />

Powder for oral<br />

suspension<br />

Powder for oral<br />

suspension<br />

Powder for solution<br />

for injection and<br />

intravenous infusion<br />

156 mg/5 ml Lek Pharmaceuticals d.d. 30/04/04<br />

457 mg/5 ml Lek Pharmaceuticals d.d. 24/05/06<br />

600 mg Lek Pharmaceuticals d.d. 31/05/05


EN<br />

790 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

644 Amoksiklav Acidum clavulanicum +<br />

Amoxicillinum<br />

650 Amoksiklav 12,5 % Acidum clavulanicum<br />

+ Amoxicillinum<br />

651 Amoksiklav 62,5 % Acidum clavulanicum<br />

+ Amoxicillinum<br />

652 Amoksiklav forte Acidum clavulanicum +<br />

Amoxicillinum<br />

653 Amoksiklav ke˛sy Acidum clavulanicum<br />

+ Amoxicillinum<br />

654 Amoksiklav tabletki Acidum clavulanicum<br />

+ Amoxicillinum<br />

Powder for solution<br />

for injection and<br />

intravenous infusion<br />

Powder for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Powder for oral<br />

suspension<br />

Bolus for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

655 Amoksycylina 60 % Amoxicillunum Powder for veterinary<br />

use<br />

656 Amoksycylina Trójwodna 10 % Amoxicillunum Suspension for veterinary<br />

use<br />

1,2 g Lek Pharmaceuticals d.d. 31/05/05<br />

Lek Pharmaceutical and<br />

Chemical Company<br />

Lek Pharmaceutical and<br />

Chemical Company<br />

31/12/08<br />

31/12/08<br />

312.5 mg/5 ml Lek Pharmaceuticals d.d. 30/04/04<br />

Lek Pharmaceutical 31/12/08<br />

Lek Pharmaceutical and<br />

Chemical Company<br />

8/11/05<br />

Vetos-Farma 6/06/05<br />

AniMedica West 31/12/07<br />

657 Amoksycyliny trójwodzian Scholz, Sowin 31/01/06<br />

658 Amoksymina 15 % L.A. Amoxiciclinum Solution for veterinary<br />

use<br />

659 Amoksywet 60 % Amoxiciclinum Powder for veterinary<br />

use<br />

660 Amoksywet inj. Amoxiciclinum Suspension for veterinary<br />

use<br />

Biowet Drwalew 31/12/08<br />

Biowet Puławy 31/12/08<br />

Biowet Puławy 31/12/08<br />

661 Amol Preparat złoz˙ony Liquid for external use Altana Consumer Health<br />

GmbH<br />

662 Amonowy bromek Ammoni bromidum BUFA b.v. Pharmaceutical<br />

Products<br />

29/02/04<br />

30/11/05<br />

663 Amonowy bromek Ammoni bromidum Pharma Cosmetic, Kraków 30/11/05<br />

664 Amonowy bromek Ammoni bromidum Pharma Zentrale 30/11/05<br />

665 Amonowy bromek Ammoni bromidum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

666 Amonowy bromek Ammoni bromidum Przedsie˛biorstwo Chmiczne<br />

Odczynniki Sp. z o.o., Lublin<br />

667 Amonowy chlorek Ammoni bromidum BUFA b.v. Pharmaceutical<br />

Products<br />

668 Amonowy chlorek Ammoni bromidum Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

669 Amonowy chlorek Ammoni bromidum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

674 Amotaks Amoxicillinum Capsules 250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

675 Amotaks Amoxicillinum Capsules 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

670 Amotaks Amoxicillinum Granules for oral<br />

solution<br />

671 Amotaks Amoxicillinum Granules for oral<br />

solution<br />

375 mg/5 ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

125 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/11/05<br />

30/11/05<br />

31/03/06<br />

31/03/06<br />

31/03/06<br />

9/12/06<br />

9/12/06<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 791<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

672 Amotaks Amoxicillinum Granules for oral<br />

solution<br />

673 Amotaks Amoxicillinum Granules for oral<br />

solution<br />

250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

250 mg/5 ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

676 Amotaks Amoxicillinum Tablets 1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

677 Amotaks — Dis Amoxicilinum Tablets 750 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

678 Amotaks — Dis Amoxicilinum Tablets 1 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

679 Amotaks — Dis Amoxicilinum Tablets 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

680 Amotaks wet. Granulat 50 % Amoxicillunum Granules for veterinary<br />

use<br />

681 Amotaks wet. Granulat 80 % Amoxicillunum Granules for veterinary<br />

use<br />

682 Amotaks wet. Tabletki 200mg Amoxicillunum Tablets for veterinary<br />

use<br />

683 Amotaks wet. Tabletki 400mg Amoxicillunum Tablets for veterinary<br />

use<br />

684 Amotaks wet. Tabletki 40mg Amoxicillunum Tablets for veterinary<br />

use<br />

685 Amoxicilin Amoxicilinum Capsules 250 mg i<br />

500 mg<br />

686 Amoxicilin Amoxicilinum Powder for<br />

suspension<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

250 mg /5 ml PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

687 Amoxicilin Amoxicilinum Tablets 1g PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

688 Amoxicillin Trihydrate 11,5 % Amoxicillunum Powder for veterinary<br />

use<br />

9/12/06<br />

9/12/06<br />

9/12/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Bremer Pharma 31/12/08<br />

691 Amoxicilline Amoxicillinum Capsules 250 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

689 Amoxicilline Amoxicillinum Granules for oral<br />

suspension<br />

690 Amoxicilline Amoxicillinum Granules for oral<br />

suspension<br />

692 Amoxicilline pro suspensione Amoxicillinum Granules for oral<br />

suspension<br />

693 Amoxicilline pro suspensione Amoxicillinum Granules for oral<br />

suspension<br />

694 Amoxicillinum 0,5 tab Amoxicillunum Tablets for veterinary<br />

use<br />

695 Amoxicillinum 1,0 tab Amoxicillunum Tablets for veterinary<br />

use<br />

696 Amoxicillinum 10 % Amoxicillunum Powder for veterinary<br />

use<br />

697 Amoxicillinum 80 % Amoxicillunum Powder for veterinary<br />

use<br />

1 g Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

500 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

125 mg/5ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

250 mg/5ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/06/06<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

Biofaktor 31/12/08<br />

Biofaktor 31/12/08<br />

Interbiowet Sp. z o.o. 17/04/05<br />

Interbiowet Sp. z o.o. 17/04/05


EN<br />

792 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

698 Amoxil Amoxicillinum Capsules 250 mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

699 Amoxil Amoxicillinum Powder for oral<br />

suspension<br />

700 Amoxinject 15 % Amoxicillunum Suspension for veterinary<br />

use<br />

703 Amoxiratio Comp Amoxicillinum +<br />

Acidum clavulanicum<br />

701 Amoxiratio Comp Amoxicillinum +<br />

Acidum clavulanicum<br />

702 Amoxiratio Comp Amoxicillinum +<br />

Acidum clavulanicum<br />

Film-coated tablets 500 mg +<br />

125 mg<br />

Powder for oral<br />

suspension<br />

Powder for oral<br />

suspension<br />

125 mg/5ml SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

(125 mg +<br />

31 mg)/5 ml<br />

(250 mg +<br />

62,5 mg)/5 ml<br />

704 Amoxy 100 Amoxiciclinum Powder for veterinary<br />

use<br />

705 Amoxy 15 % pro inj. Amoxicillunum Suspension for veterinary<br />

use<br />

706 Amoxycillin Amoxicillinum Powder for oral<br />

suspension<br />

707 Amoxycillin 15 WSP Amoxicillunum Powder for veterinary<br />

use<br />

30/04/04<br />

30/04/04<br />

Bremer Pharma 31/12/08<br />

ratiopharm GmbH 31/12/08<br />

ratiopharm GmbH 31/12/08<br />

ratiopharm GmbH 31/12/08<br />

Vet-Pharm 31/12/08<br />

Eurovet Animal Health 30/07/06<br />

250 mg/5ml Norton Healthcare Ltd. 30/06/04<br />

Dopharma 30/06/04<br />

708 Amoxycillin 250 Amoxicillinum Capsules 250 mg Generics (UK) Limited 31/12/08<br />

709 Amoxycillin 500 Amoxicillinum Capsules 500 mg Generics (UK) Limited 31/12/08<br />

710 Amoxy-Col WSP Amoxicillunum +<br />

Colistinum<br />

Powder for veterinary<br />

use<br />

711 Amoxyveto Amoxicillunum Powder for veterinary<br />

use<br />

712 Amphochol Fumariae herba<br />

extractum spissum<br />

713 Amphocil Amphotericinum Lyophilisate for<br />

solution for infusion<br />

714 Amphocil Amphotericinum Lyophilisate for<br />

solution for infusion<br />

Dopharma 31/12/08<br />

V.M.D. 31/12/08<br />

Tablets Herbapol Łódz´ S.A. 30/09/07<br />

100 mg Torrex Pharma GesmbH 30/04/04<br />

50 mg Torrex Pharma GesmbH 30/04/04<br />

715 Amphosca a I'orchitine Tablets Lehning Laboratoires 31/12/08<br />

716 Amphosca a I'ovarine Tablets Lehning Laboratoires 31/12/08<br />

717 Ampicilin Natrium Ampicilinum Substance for<br />

intravenous or<br />

intravascular injection<br />

0,5 g Brinsalov 31/12/08<br />

719 Ampicillin Ampicillinum Capsules 250 mg Pharmachim-Holding AD 31/12/07<br />

720 Ampicillin Ampicillinum Capsules 250 mg ZAO BRINSALOV A 31/12/07<br />

718 Ampicillin Ampicillinum Granules for oral<br />

solution<br />

721 Ampicillin Ampicillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

722 Ampicillin Ampicillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

30/04/05<br />

14/09/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 793<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

723 Ampicillin Ampicillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

724 Ampicillin Ampicillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

725 Ampicillin Ampicillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

726 Ampicillin Ampicillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

250 mg Pharmachim-Holding AD 30/04/04<br />

250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/04/05<br />

500 mg Pharmachim-Holding AD 30/04/04<br />

500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

727 Ampicillin Ampicillinum Tablets 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

728 Ampicillin 20 % Ampicillinum Suspension for veterinary<br />

use<br />

729 Ampicillin pro suspensione Ampicillinum Granules for oral<br />

suspension<br />

730 Ampiclox L.C. Ampicillinum +<br />

Cloxacillnum<br />

Intramammary<br />

suspension<br />

30/04/05<br />

31/12/07<br />

Bremer Pharma 31/12/08<br />

250 mg/5ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

for veterinary<br />

use<br />

731 Ampicylina 20 % inj. Ampicillinum Suspension for veterinary<br />

use<br />

31/12/08<br />

Pfizer Italia S.r.I. 6/03/05<br />

Biowet Drwalew 31/12/08<br />

732 Ampiryna Acidum acetylsalicylicum Tablets 325 mg L.T.York Pharmacal Co. 31/05/05<br />

733 Ampisur Ampicillinum +<br />

Cloxacillnum<br />

Suspension for veterinary<br />

use<br />

734 Ampitab 180 mg Ampicillinum Tablet for veterinary<br />

use<br />

735 Ampitab 50 mg Ampicillinum Tablet for veterinary<br />

use<br />

736 Ampitab Suspension Ampicillinum Suspension for veterinary<br />

use<br />

737 Amprol 12 % Chlorowodorek<br />

amprolium<br />

Solution for veterinary<br />

use<br />

738 Amprolmix 25 % Amprolium Premix for veterinary<br />

use<br />

739 Amuril 10 % Amoxicillunum Powder for veterinary<br />

use<br />

740 Amuril 50 % Amoxicillunum Powder for veterinary<br />

use<br />

Ceva Sante Animale 14/08/05<br />

Vetoquinol S.A. 3/11/05<br />

Vetoquinol S.A. 3/11/05<br />

Vetoquinol S.A. 3/11/05<br />

Merial 31/12/08<br />

Merial 3/07/07<br />

Lek Pharmaceutical and<br />

Chemical Company<br />

Lek Pharmaceutical and<br />

Chemical Company<br />

23/08/08<br />

3/09/04<br />

741 Anacardium-Homaccord Amp. Heel GmbH 31/12/08<br />

742 Anacardium-Homaccord Drops Heel GmbH 31/12/08<br />

743 Anadin Paracetamolum Tablets 0.5 g Pennex Products Co. Inc. 31/12/06<br />

744 Anadin dla dzieci Paracetamolum Buccal tablet 80 mg Pennex Products Co. Inc. 31/12/05<br />

746 Anafranil Clomipraminum Film-coated tablets 10 mg Novartis Pharma AG 30/09/04<br />

747 Anafranil Clomipraminum Film-coated tablets 25 mg Novartis Pharma AG 30/09/04


EN<br />

794 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

745 Anafranil Clomipraminum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

748 Anafranil SR 75 Clomipraminum Film-coated, prologed<br />

release tablets<br />

12.5 mg/ml Novartis Pharma AG 30/09/04<br />

75 mg Novartis Pharma AG 30/09/04<br />

749 Anagallis comp. granulki WALA-Heilmittel GmbH 31/08/05<br />

750 Anagallis comp. inj. WALA-Heilmittel GmbH 31/08/05<br />

751 Analget Coffeinum +<br />

Paracetamolum +<br />

Propyphenazonum<br />

Tablets 50mg +<br />

200mg +<br />

200mg<br />

Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

752 Analgin Ibuprofenum Film-coated tablets 200 mg BERLIN — CHEMIE AG<br />

(Menarini Group)<br />

753 Analgin Forte Ibuprofenum Film-coated tablets 400 mg BERLIN — CHEMIE AG<br />

(Menarini Group)<br />

755 Analgol Preparat złoz˙ony Gel Przedsie˛biorstwo Produkcji<br />

Farmaceutyczno<br />

Kosmetycznej ‘Profarm’ Sp. z<br />

o.o., Le˛bork<br />

754 Analgol Preparat złoz˙ony Ointment Profarm — Przedsie˛biorstwo<br />

Produkcji Farmaceutyczno-<br />

Kosmetycznej Sp. z o.o.<br />

756 Analgolan Methylis salicylas +<br />

Camphorum<br />

Ointment Profarm — Przedsie˛biorstwo<br />

Produkcji Farmaceutyczno-<br />

Kosmetycznej Sp. z o.o.<br />

31/01/05<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

757 Analux Phenylephrinum Eye drops, solution 1.25 mg/ml Alcon Cusi, S.A. 30/04/04<br />

758 Anandron Nilutamidum Tablets 50 mg Laboratoires Cassenne 30/06/04<br />

759 Anapran Naproxenum Film-coated tablets 220 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

760 Anapran Naproxenum Film-coated tablets 275 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

761 Anapran Naproxenum Film-coated tablets 550 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

762 Anatetan Szczepionka<br />

przeciwte˛z˙cowa<br />

Liquid for veterinary<br />

use<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

11/10/06<br />

31/12/05<br />

31/12/05<br />

31/12/08<br />

763 Anavenol Coated tablets Lečiva a.s. 31/07/04<br />

764 Ancotil Flucytosinum Solution for<br />

intravenous infusion<br />

10 mg/ml ICN Polfa Rzeszów S.A. 31/01/05<br />

765 Ancotil Flucytosinum Tablets 500 mg ICN Polfa Rzeszów S.A. 31/01/05<br />

766 Ancrusal Sucralfatum Tablets 500 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

767 Andepin Fluoxetinum Capsules 20 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

768 Andepin Simvastatinum Capsules 20 mg Przedsie˛biorstwo<br />

Farmaceutyczno —<br />

Chemiczne ‘Synteza’ Sp. z<br />

o.o.<br />

31/01/06<br />

31/05/06<br />

31/05/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 795<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

769 Andol C Acidum<br />

acetylosalicylicum +<br />

Acidum ascorbicum<br />

Effervescent tablets 400 mg +<br />

240 mg<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

770 Andraxan Flutamidum Film-coated tablets 250 mg Medicom International s.r.o. 26/09/07<br />

771 Androcur Cyproteronum Tablets 50 mg Schering AG 31/07/04<br />

772 Androgest Cyproteronum Tablets 50 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

773 Androstatin Finasteridum Film-coated tablets 1 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

774 Anevit Preparat złoz˙ony Syrup Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

775 Anexate Flumazenilum Solution for injection 100 mcg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

776 Angi Sept Preparat złoz˙ony tabletki od bólu<br />

gardła<br />

Naturwaren OhgDr Peter<br />

Theiss<br />

777 Angina comp. krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

31/12/08<br />

31/12/08<br />

12/10/05<br />

31/05/04<br />

31/12/08<br />

30/11/05<br />

778 Angin-Heel S Tablets Heel GmbH 30/06/07<br />

779 Angin-Heel SD Tablets Heel GmbH 31/07/05<br />

780 Anginosep Cetylpyridini chloridum Buccal tablets 2,5 mg Polfarmex Sp. z o.o. 31/12/08<br />

781 Angio-Injeel Amp. Heel GmbH 31/12/08<br />

782 Angiopas krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

783 Aniclindan 75 Clindamycinum Tablet for veterinary<br />

use<br />

784 Aniclox Ampicillinum +<br />

Cloxacillnum<br />

Intrauterine stick for veterinary<br />

use<br />

785 Anipracit Praziquantelum Solution for veterinary<br />

use<br />

786 Aniprazol Prazikwantel,<br />

Fenbendazol<br />

Tablet for veterinary<br />

use<br />

787 Anipyran Pyrantelu embonian Suspension for veterinary<br />

use<br />

788 Aniron Wycia˛g wodny<br />

zhydrolizowanej<br />

wa˛troby, Siarczan<br />

z˙elazawy, Siarczan<br />

manganawy, Chlorek<br />

kobaltawy, Siarczek<br />

miedziowy<br />

Syrup for veterinary<br />

use<br />

789 Anlostin Lovastatinum Tablets 20 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

AniMedica West GmbH 30/01/06<br />

AniMedica West 24/05/07<br />

AniMedica West 31/12/08<br />

AniMedica West 31/12/08<br />

AniMedica West 9/06/05<br />

Jelfa 24/08/04<br />

28/02/06<br />

790 Anopyrin 30 Acidum acetylsalicylicum Tablets 30 mg Slovakofarma a.s. 31/12/08<br />

791 Anopyrin 100 Acidum acetylsalicylicum Tablets 100 mg Slovakofarma a.s. 31/12/08<br />

792 Anopyrin 400 Acidum acetylsalicylicum Tablets 0.4 g Slovakofarma a.s. 31/12/08


EN<br />

796 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

793 Antalv Acidum mefenamicum Tablets 20 mg Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

794 Antares 120 Tablets 120 mg<br />

kawa-pironów<br />

Krewel Meuselbach GmbH<br />

Gebren<br />

30/10/05<br />

6/07/05<br />

795 Antaxone Naltrexonum Capsules 10 mg Zambon Group S.p.A. 31/12/08<br />

796 Antaxone Naltrexonum Capsules 50 mg Zambon Group S.p.A. 31/12/08<br />

797 Antaxone Naltrexonum Solution for<br />

oromucosal use<br />

798 Antaxone Naltrexonum Solution for<br />

oromucosal use<br />

799 Anteovin Ethinylestradiolum +<br />

Levonorgestrelum<br />

800 Anti — Rhesus (D)<br />

Immunoglobuline<br />

Immunoblobulinum<br />

humanum anti — D<br />

Tablets tabletki białe:<br />

levonorgestrel<br />

0,05 mg,<br />

etynylestradiol<br />

0,05 mg;<br />

tabletki<br />

róz˙owe:<br />

levonorgestrel<br />

0,125 mg,<br />

etynylestradiol<br />

0,05 mg.<br />

Solution for<br />

intramuscular<br />

injection<br />

801 Anticoccid Amprolium Powder for veterinary<br />

use<br />

50 mg/20 ml Zambon Group S.p.A. 31/12/08<br />

100 mg/20 ml Zambon Group S.p.A. 31/12/08<br />

Gedeon Richter Ltd. 30/06/04<br />

1000 j.m. Sanquin, CLB Products<br />

Division<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

802 Anticol Disulfiramum Tablets 500 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

24/05/04<br />

31/01/06<br />

803 Antidiab Glipizidum Tablets 5 mg Krka d.d., Novo mesto 31/08/04<br />

804 Antidol 10 Codeinum +<br />

Paracetamolum<br />

805 Antidol 15 Paracetamolum +<br />

Codeinum<br />

806 Antidol 20 Codeinum +<br />

Paracetamolum<br />

Tablets 10mg +<br />

300mg<br />

Tablets 500 mg +<br />

15 mg<br />

Tablets 20mg +<br />

300mg<br />

ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

807 Antidol P Paracetamolum Tablets 500 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

808 Antidral Aluminii chloridum Coutanous liquid 100 mg/g Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

809 Antigripinol Paracetamolum +<br />

Acidum ascorbicum +<br />

Chlorphenaminum<br />

810 Antinervinum Crataegi tinctura +<br />

Lupuli strobili tinctura +<br />

Valerianae tinctura<br />

811 Antineuralgiae E Acidum acetylsalicylicum<br />

+ Ethenzamidum<br />

Effervescent tablets 500 mg +<br />

200 mg +<br />

7,5 mg<br />

15/11/06<br />

30/09/07<br />

31/01/05<br />

30/09/07<br />

31/12/05<br />

NP. Pharma Sp. z o.o. 31/12/08<br />

Syrup Konwent Zakonu Bonifratrów 27/09/06<br />

Tablets Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/12/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 797<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

812 Antineuralgiae K Acetulsalicylicum<br />

acidum,<br />

Etoxybenzamidum,<br />

Coffeinum<br />

Tablets 16 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

813 Antiparasitic Shampoo Permetryna Shampoo for veterinary<br />

use<br />

814 Antiparen chlorek wapnia,<br />

chlorek magnezu,<br />

chlorek sodu, glukoza<br />

Solution for veterinary<br />

use<br />

815 Antirobe 150 mg Clindamycinum Capsule for veterinary<br />

use<br />

816 Antirobe 25 mg Clindamycinum Capsule for veterinary<br />

use<br />

817 Antirobe 75 mg Clindamycinum Capsule for veterinary<br />

use<br />

818 Antisedan Atipamezolum Solution for veterinary<br />

use<br />

819 Antistax ® Vitis viniferae fol. extr.<br />

sicc.<br />

820 Antithrombin III Antithrombinum III Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

infusion<br />

821 Antithrombin III Antithrombinum III Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

infusion<br />

822 Antithrombin III Grifolos Antithrombinum III Powder and solvent<br />

for solution for<br />

infusion<br />

823 Antithrombin III Grifolos Antithrombinum III Powder and solvent<br />

for solution for<br />

infusion<br />

31/12/08<br />

Francodex S.A. 15/02/06<br />

Biowet Gorzów 31/12/08<br />

Pharmacia N.V./S.A. 25/03/07<br />

Pharmacia N.V./S.A. 25/03/07<br />

Pharmacia N.V./S.A. 25/03/07<br />

Orion Corporation 16/02/05<br />

Capsules, hard 180 mg Boehringer Ingelheim<br />

International GmbH<br />

1000 j.m.<br />

antytrombiny<br />

III<br />

500 j.m.<br />

antytrombiny<br />

III<br />

31/12/08<br />

Baxter AG 30/11/04<br />

Baxter AG 30/11/04<br />

1000 j.m. Instituto Grifols S.A. 14/03/06<br />

500 j.m. Instituto Grifols S.A. 14/03/06<br />

824 Anti-Uron Mesnum Solution for injection 100 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

825 Antiverm dla koni Pyrantelu embonian Paste for veterinary<br />

use<br />

826 Antiverm dla kotów Pyrantelu embonian Paste for veterinary<br />

use<br />

827 Antiverm dla psów Pyrantelu embonian Paste for veterinary<br />

use<br />

828 Antiverm junior Pyrantel, febantel Paste for veterinary<br />

use<br />

829 Antiverm Maxi plus dla psów Pyrantel, prazikwantel,<br />

febantel<br />

830 Antiverm plus dla kotów Embonian pyrantelu,<br />

prazikwantel<br />

831 Antiverm plus dla psów Pyrantel, prazikwantel,<br />

febantel<br />

Paste for veterinary<br />

use<br />

Paste for veterinary<br />

use<br />

Paste for veterinary<br />

use<br />

Grodziskie Zakłady<br />

Farmaceutyczne Polfa<br />

Grodziskie Zakłady<br />

Farmaceutyczne Polfa<br />

Grodziskie Zakłady<br />

Farmaceutyczne Polfa<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

30/11/05<br />

16/11/04<br />

17/08/05<br />

17/05/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

832 Antivir Aciclovirum Cream 50 mg/g Sanofi-Synthelabo Sp. z o.o. 30/10/05<br />

833 Antivir Aciclovirum Tablets 200 mg Sanofi-Synthelabo Sp. z o.o. 30/04/05


EN<br />

798 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

834 Antotalgin Phenazonum Ear drops Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

31/12/08<br />

835 Antrex Calcii folinas Tablets 15 mg Orion Corporation 31/05/04<br />

836 Antycolimix T Sulfachloropirydazyny<br />

sól sodowa,<br />

Tripelenaminy<br />

chlorowodorek,<br />

Trimetoprim<br />

837 Antygrypin Acidum acetylsalicylicum<br />

+ Coffeinum<br />

838 Antypot Acidum boricum +<br />

Acidum salicylicum<br />

839 Antytoksyna błonicza końska Antitoxinum<br />

diphthericum equinum<br />

840 Antytoksyna botulinowa<br />

wielowaz˙na A+B+E<br />

841 Antytoksyna jadu z˙mij Immunoserum contra<br />

venena viperarum<br />

europaearum<br />

842 Antytoksyna te˛z˙cowa bydle˛ca Antytoksyna te˛z˙cowa<br />

bydle˛ca<br />

843 Antytoksyna te˛z˙cowa końska Antitoxinum tetanicum<br />

equinum<br />

844 Antytoksyna te˛z˙cowa końska Antytoksyna te˛z˙cowa<br />

konska<br />

845 Antytoksyna te˛z˙cowa końska Antytoksyna te˛z˙cowa<br />

konska<br />

846 Antytoksyna te˛z˙cowa końska<br />

liofilizowana<br />

848 Anusol Balsamum peruvianum +<br />

Bismuthum oxydum +<br />

Zinci oxydum<br />

847 Anusol Balsamum peruvianum +<br />

Bismuthum oxydum +<br />

Zinci oxydum<br />

Powder for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Tablets Farmaceutyczno-Chemiczna<br />

Spółdzielnia Pracy GALENUS<br />

Coutanous powder Zakład Produkcyjno-<br />

Usługowy FARKO<br />

Solution for<br />

intramuscular<br />

injection<br />

Botulinum antitoxin Solution for<br />

intramuscular or<br />

intravenous injection<br />

Solution for<br />

intramuscular<br />

injection<br />

Solution for<br />

intramuscular<br />

injection<br />

Lyophilisate for<br />

solution for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

Solution for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

Solution for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

10000 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

500 j.a. Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

3000 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

3000 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

10000 j.a. Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

20000 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

Tetanus antitoxin Injection (lyophilisate) 3000 j.a. Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

849 Anzatax Paclitaxelum Concentrate for<br />

solution for infusion<br />

850 Anzemet 100 Dolasetronum Solution for<br />

intravenous injection<br />

851 Anzemet 12,5 Dolasetronum Solution for<br />

intravenous injection<br />

17/08/04<br />

30/04/05<br />

31/12/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

Ointment Gödecke AG 31/07/04<br />

Suppository Gödecke AG 31/07/04<br />

6 mg/ml FH Faulding & Co. Ltd. 31/12/08<br />

100 mg/5ml Hoechst Marion Roussel<br />

Deutschland GmbH<br />

12.5 mg/<br />

0,625ml<br />

Hoechst Marion Roussel<br />

Deutschland GmbH<br />

852 Anzemet 200 Dolasetronum Film-coated tablets 200 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

5/07/06<br />

5/07/06<br />

5/07/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 799<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

853 Anzemet 50 Dolasetronum Film-coated tablets 50 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

5/07/06<br />

854 Apadon Paracetamolum Film-coated tablets 500 mg Labpharm Sp. z.o.o. 31/12/08<br />

856 APAP Paracetamolum Film-coated tablets 500 mg US Pharmacia International<br />

Inc.<br />

855 APAP Paracetamolum Oral drops,<br />

suspension<br />

100 mg/ml US Pharmacia International<br />

Inc.<br />

31/07/04<br />

31/07/04<br />

857 Apap Paracetamolum Oral suspension 160 mg/5ml US Pharmacia Sp. z o.o. 31/01/06<br />

858 Apap C Plus Paracetamolum +<br />

Acidum ascorbicum<br />

859 Apap noc Diphenhydraminum +<br />

Paracetamolum<br />

860 Apatinac Hyperici herbae<br />

extractum siccum<br />

861 Apemix (poprzednia nazwa:<br />

stomamix)<br />

Angelicae radix,<br />

Gentianae radix,<br />

Absinthii herba<br />

862 Aperisan gel Salviae folium extractum<br />

fluidum<br />

Effervescent tablets 500 mg +<br />

300 mg<br />

US Pharmacia Sp. z o.o. 31/12/08<br />

Film-coated tablets US Pharmacia International<br />

Inc.<br />

Film-coated tablets 184 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

Capsules, hard 169 mg +<br />

157,5 mg +<br />

113,5 mg<br />

4/07/07<br />

25/10/06<br />

Agropharm S.A. 31/12/08<br />

Oromucosal gel 200 mg/g Dentinox Gesellschaft fur<br />

pharmaceutische Praparate<br />

Lenk & Schuppan<br />

863 Aphtin Natrii tetraboras Oromucosal solution 200 mg/g Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

864 Aphtin Natrii tetraboras Oromucosal solution 200 mg/g Cefarm Gdańsk<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

865 Aphtin Natrii tetraboras Oromucosal solution 200 mg/g Cefarm Lublin S.A.<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

866 Aphtin Natrii tetraboras Oromucosal solution 200 mg/g Coel s.c.- Laboratorium<br />

Farmaceutyczne Wytwórnia<br />

Euceryny<br />

31/01/05<br />

30/10/05<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

867 Aphtin Natrii tetraboras Oromucosal solution 200 mg/g Farmina Sp. z o.o. 31/01/06<br />

868 Aphtin Natrii tetraboras Oromucosal solution 200 mg/g Microfarm s.c.<br />

Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

869 Aphtin Natrii tetraboras Oromucosal solution 200 mg/g Prolab s.c. — Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Produkcyjno-Analityczno-<br />

Handlowe s.c. Paterek<br />

31/01/06<br />

31/12/05<br />

870 Aphtin Oromucosal solution 200 mg/g Augmed 30/10/05<br />

871 Aphtin Oromucosal solution 200 mg/g Laboratorium Galenowe<br />

Olsztyn Sp. zo.o.<br />

30/10/05<br />

872 Apiderm — Mas´ć propolisowa Ointment 30 mg/g Bartpol s.c. Z. Kostrzewski 30/10/05<br />

873 ApiHelix Syrup 101.9 mg/<br />

5ml<br />

Apipol — Farma Sp. z o.o.<br />

Przedsie˛biorstwo Pszczelarsko<br />

— Farmaceutyczne<br />

874 Apilecitan PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

27/06/07<br />

31/12/08


EN<br />

800 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

875 Apilepsin Acidum valproicum Film-coated tablets 300 mg Krka d.d., Novo mesto 31/07/04<br />

876 Apinorm Syrup Apipol — Farma Sp. z o.o.<br />

Przedsie˛biorstwo Pszczelarsko<br />

— Farmaceutyczne<br />

877 Apipropol M Ointment 60 mg/g Wytwórnia Leków<br />

Naturalnych APIHERBA Dr<br />

Edward Kałuz˙ny<br />

878 Apipropol R Cutaneous and<br />

mucosa membrane<br />

liquid<br />

879 Apipulmol Ammonii chloridum +<br />

Guaiacolsulfonatum<br />

100 mg/ml Wytwórnia Leków<br />

Naturalnych APIHERBA Dr<br />

Edward Kałuz˙ny<br />

Syrup Apipol — Farma Sp. z o.o.<br />

Przedsie˛biorstwo Pszczelarsko<br />

— Farmaceutyczne<br />

880 Apipulmol Syrup Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

881 Apirektal Propolis extractum Suppository Przedsie˛biorstwo<br />

Pszczelarsko-Farmaceutyczne<br />

‘APIPOL-FARMA’ Sp. z o.o.,<br />

Mys´lenice<br />

882 Apis similiaplex krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

31/12/08<br />

31/08/05<br />

31/08/05<br />

31/08/05<br />

31/08/05<br />

31/12/08<br />

30/11/05<br />

883 APIS/BELLADONNA Granules WALA-Heilmittel GmbH 24/05/07<br />

884 Apis/Belladonna cum Mercurio<br />

granulki<br />

885 Apis/Belladonna cum Mercurio<br />

inj.<br />

WALA-Heilmittel GmbH 31/08/05<br />

WALA-Heilmittel GmbH 31/08/05<br />

886 Apis/Levisticum II granulki WALA-Heilmittel GmbH 31/08/05<br />

887 Apis/Levisticum II inj. WALA-Heilmittel GmbH 31/08/05<br />

888 Apis-Homaccord Amp. Heel GmbH 31/12/07<br />

889 Apis-Homaccord Drops Heel GmbH 31/12/07<br />

890 Apitraz Amitrazum Bee- hive strip for veterinary<br />

use<br />

Biowet Puławy 31/12/08<br />

891 Apitussic Guaiacolsulfonatum Syrup 52 mg/ 5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

892 Apitussic Syrup 52 mg/5 ml Apipol — Farma Sp. z o.o.<br />

Przedsie˛biorstwo Pszczelarsko<br />

— Farmaceutyczne<br />

893 Apivag Propolis extractum Pessary Przedsie˛biorstwo Pszczelarsko<br />

Farmaceutyczne ‘APIPOL-<br />

FARMA’ Sp. z o.o., Mys´lenice<br />

894 Apiwarol Amitrazum Tablet for veterinary<br />

use<br />

31/08/05<br />

30/10/05<br />

31/12/08<br />

Biowet Puławy 21/06/04<br />

895 Apiz˙el Propolis extractum Gel 50 mg/1g Przedsie˛biorstwo<br />

Pszczelarsko-Farmaceutyczne<br />

‘APIPOL-FARMA’ Sp. z o.o.,<br />

Mys´lenice<br />

31/12/08<br />

896 Aplaket Ticlopidinum Film-coated tablets 250 mg Rottapharm S.r.l. 31/12/08<br />

897 Apo — Carbam Carbamazepinum Tablets 200 mg Apotex Inc. 31/12/08<br />

898 Apo — Diltiaz Diltiazemum Film-coated tablets 60 mg Apotex Inc. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 801<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

899 Apo — Doxan 1 Doxazosinum Tablets 1 mg Apotex Inc. 31/12/08<br />

900 Apo — Doxan 2 Doxazosinum Tablets 2 mg Apotex Inc. 31/12/08<br />

901 Apo — Doxan 4 Doxazosinum Tablets 4 mg Apotex Inc. 31/12/08<br />

902 Apo — Fluoxetine Fluoxetinum Capsules 20 mg Apotex Inc. 31/12/08<br />

903 Apo — Indap Indapamidum Film-coated tablets 2,5 mg Apotex Inc. 31/12/08<br />

904 Apo — Keto 100 Ketoprofenum Film-coated tablets 100 mg Apotex Inc. 31/12/08<br />

905 Apo — Keto 50 Ketoprofenum Film-coated tablets 50 mg Apotex Inc. 31/12/08<br />

906 Apo — Keto SR Ketoprofenum Film-coated,<br />

prolonged release<br />

tablets<br />

200 mg Apotex Inc. 31/12/08<br />

907 Apo — Lazid Gliclazidum Tablets 80 mg Apotex Inc. 31/12/08<br />

908 Apo — Lovastatin Lovastatinum Tablets 20 mg Apotex Inc. 31/12/08<br />

909 Apo — Parox 20 Paroxetinum Film-coated tablets 20 mg Apotex Inc. 31/12/08<br />

910 Apo-Acyclovir 200 Aciclovirum Tablets 200 mg Apotex Inc. 14/02/07<br />

911 Apo-Acyclovir 400 Aciclovirum Tablets 400 mg Apotex Inc. 14/02/07<br />

912 Apo-Allopurinol Allopurinolum Tablets 100 mg Apotex Inc. 30/06/04<br />

913 Apo-Amoxi 125 mg/5 ml Amoxicillinum Powder for oral<br />

suspension<br />

125 mg/5 ml Apotex Inc. 27/09/06<br />

914 Apo-Amoxi 250 Amoxicillinum Capsules 250 mg Apotex Inc. 30/04/04<br />

915 Apo-Amoxi 250 mg/5 ml Amoxicillinum Powder for oral<br />

suspension<br />

250 mg/5 ml Apotex Inc. 27/09/06<br />

916 Apo-Amoxi 500 Amoxicillinum Capsules 500 mg Apotex Inc. 30/04/04<br />

917 Apo-Atenol 100 Atenololum Tablets 100 mg Apotex Inc. 30/06/04<br />

918 Apo-Atenol 50 Atenololum Tablets 50 mg Apotex Inc. 30/06/04<br />

919 Apo-Cefaclor Cefaclorum Powder for oral<br />

suspension<br />

250 mg/5ml Apotex Inc. 21/06/06<br />

920 Apo-Clodin Ticlopidinum Film-coated tablets 250 mg Apotex Inc. 17/01/07<br />

921 Apo-Diclo 25 Diclofenacum Film-coated,<br />

gastro-resistant tablets<br />

922 Apo-Diclo 50 Diclofenacum Film-coated,<br />

gastro-resistant tablets<br />

25 mg Apotex Inc. 30/06/04<br />

50 mg Apotex Inc. 30/06/04<br />

923 Apo-Famo 20 Famotidinum Film-coated tablets 20 mg Apotex Inc. 15/11/06<br />

924 Apo-Famo 40 Famotidinum Film-coated tablets 40 mg Apotex Inc. 15/11/06<br />

925 Apo-Feno 100 Fenofibratum Capsules 100 mg Apotex Inc. 27/09/06<br />

926 Apo-Feno 200M Fenofibratum Capsules 200 mg Apotex Inc. 27/09/06<br />

927 Apo-Flutam Flutamidum Film-coated tablets 250 mg Apotex Inc. 25/04/07<br />

928 APO-go Apomorphini<br />

hydrochloridum<br />

929 APO-go PEN Apomorphini<br />

hydrochloridum<br />

Solution for<br />

subcutanous injection<br />

Solution for<br />

subcutanous injection<br />

10 mg/ml Forum Products Ltd 31/07/05<br />

10 mg/ml Forum Products Ltd 31/07/05


EN<br />

802 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

930 Apo-ISDN 10 Isosorbidi dinitras Tablets 10 mg Apotex Inc. 31/07/04<br />

931 Apo-ISDN 5 Isosorbidi dinitras Sublingual tablets 5 mg Apotex Inc. 31/07/04<br />

932 Apo-Mefen Acidum mefenamicum Capsules 250 mg Apotex Inc. 11/11/06<br />

933 Apo-Nadol 40 Nadololum Tablets 40 mg Apotex Inc. 30/06/04<br />

934 Apo-Nadol 80 Nadololum Tablets 80 mg Apotex Inc. 30/06/04<br />

935 Apo-Naproxen 125 Naproxenum Tablets 125 mg Apotex Inc. 31/07/04<br />

936 Apo-Naproxen 250 Naproxenum Tablets 250 mg Apotex Inc. 31/07/04<br />

937 Apo-Nifed Nifedipinum Capsules 10 mg Apotex Inc. 30/06/04<br />

938 Apo-Pentox 400 SR Pentoxifyllinum Film-coated, prologed<br />

release tablets<br />

400 mg Apotex Inc. 21/06/06<br />

939 Apo-Piroxicam 10 Piroxicamum Capsules 10 mg Apotex Inc. 30/06/04<br />

940 Apo-Piroxicam 20 Piroxicamum Capsules 20 mg Apotex Inc. 30/06/04<br />

941 Apo-Ranitidine 150 Ranitidinum Film-coated tablets 150 mg Apotex Inc. 31/07/04<br />

942 Apo-Ranitidine 300 Ranitidinum Film-coated tablets 300 mg Apotex Inc. 31/07/04<br />

943 Apo-Selin Selegilinum Tablets 5 mg Apotex Inc. 6/12/06<br />

944 Apo-Sulfatrim Sulfamethoxazolum +<br />

Trimethoprimum<br />

Tablets 480 mg Apotex Inc. 30/04/04<br />

945 Apo-Tiapro 200 Acidum tiaprofenicum Film-coated tablets 200 mg Apotex Inc. 26/04/06<br />

946 Apo-Tiapro 300 Acidum tiaprofenicum Film-coated tablets 300 mg Apotex Inc. 26/04/06<br />

947 Apo-Timol 10 Timololum Tablets 10 mg Apotex Inc. 30/06/04<br />

948 Apo-Timol 20 Timololum Tablets 20 mg Apotex Inc. 30/06/04<br />

949 Apo-Timol 5 Timololum Tablets 5 mg Apotex Inc. 30/06/04<br />

950 Apo-Trifluoperazine 1 Trifluoperazinum Film-coated tablets 1 mg Apotex Inc. 30/06/04<br />

951 Apo-Trifluoperazine 10 Trifluoperazinum Film-coated tablets 10 mg Apotex Inc. 30/06/04<br />

952 Apo-Trifluoperazine 2 Trifluoperazinum Film-coated tablets 2 mg Apotex Inc. 30/06/04<br />

953 Apo-Trifluoperazine 20 Trifluoperazinum Film-coated tablets 20 mg Apotex Inc. 30/06/04<br />

954 Apo-Trifluoperazine 5 Trifluoperazinum Film-coated tablets 5 mg Apotex Inc. 30/06/04<br />

955 Apo-Verap 120 Verapamilum Film-coated tablets 120 mg Apotex Inc. 30/06/04<br />

956 Apo-Verap 80 Verapamilum Film-coated tablets 80 mg Apotex Inc. 30/06/04<br />

957 Appertex Klazuril Tablet for veterinary<br />

use<br />

958 Apralan 100 Premix Apramycyny siarczan Premix for veterinary<br />

use<br />

959 Apralan Soluble Powder Apramycyny siarczan Powder for veterinary<br />

use<br />

Janssen Pharmaceutica n.v. 30/01/06<br />

Elanco Animal Health 11/03/04<br />

Elanco Animal Health 4/03/04<br />

960 Apranax Naproxenum Film-coated tablets 550 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

961 Apres 200 Acebutolum Film-coated tablets 200 mg Kutnowskie Zakłady<br />

Farmaceutyczne Polfa Kutno<br />

S.A.<br />

31/05/04<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 803<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

962 Apres 400 Acebutolum Film-coated tablets 400 mg Kutnowskie Zakłady<br />

Farmaceutyczne Polfa Kutno<br />

S.A.<br />

31/12/08<br />

963 Aprofen Ibuprofenum Effervescent tablets 200 mg Polfarmex S.A. 31/12/08<br />

964 Aprovel Irbesartanum Tablets 150 mg Sanofi Pharma BMS SNC 31/12/08<br />

965 Aprovel Irbesartanum Tablets 300 mg Sanofi Pharma BMS SNC 31/12/08<br />

966 Aprovel Irbesartanum Tablets 75 mg Sanofi Pharma BMS SNC 31/12/08<br />

967 APS I — sztyft do nosa Nasal stick Scan-Anida sp. z o.o. 31/08/05<br />

968 APS II — sztyft do nosa Nasal stick Scan-Anida sp. z o.o. 31/08/05<br />

969 Apsik Oxymetazolum Nasal drops, solution 0,05 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

970 Apsik Oxymetazolum Nasal drops, solution 0,03 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

971 Apsik Oxymetazolum Nasal drops, solution 0,01 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

972 Aptovac Inaktywowana<br />

szczepionka dla s´wiń<br />

przeciw zakaz˙eniom<br />

układu oddechowego<br />

wywoływanym przez<br />

Actionobacillus<br />

pleuropneumoniae i<br />

Pasteurella multocida<br />

Emulsion for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Biowet Puławy Sp. z o.o. 25/03/07<br />

973 Apydan Oxcarbazepinum Tablets 300 mg Desitin Arzneimittel GmbH 31/12/08<br />

974 Apydan Oxcarbazepinum Tablets 600 mg Desitin Arzneimittel GmbH 31/12/08<br />

975 Aqua Maris Preparat balneologiczny Nasal wash Jadran Galenshij Laboratenj 31/12/08<br />

976 Aqua pro iniectione Aqua pro injectione Solvent for parenteral<br />

use<br />

977 Aqua pro iniectione Aqua pro injectione Solvent for parenteral<br />

use<br />

978 Aqua Pro Injectione Aqua pro injectione Solvent for parenteral<br />

use<br />

979 Aqua pro injectione Aqua pro injectione Solvent for parenteral<br />

use<br />

Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/01/06<br />

Baxter Terpol Sp. z o.o. 31/01/06<br />

Baxter Healthcare Ltd. 31/07/04<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

980 Aqua Pro Irrigatione Aqua Aqua for rinse Lubelskie Zakłady<br />

Farmaceutyczne POLFA<br />

Spółka Akcyjna<br />

31/01/06<br />

30/09/07<br />

981 AQUILINUM comp. Amp. 1 g WALA-Heilmittel GmbH 24/05/07<br />

982 AQUILINUM comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

983 Aradicator inaktywowana<br />

szczepionka dla s´wiń<br />

zawieraja˛ca antygeny<br />

bordetella<br />

bronchiseptica i<br />

pasteurella multocida<br />

Suspension for veterinary<br />

use<br />

Pfizer 31/12/08<br />

984 Arava Leflunomidum Film-coated tablets 10 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

31/12/08


EN<br />

804 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

985 Arava Leflunomidum Film-coated tablets 20 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

986 Arava Leflunomidum Film-coated tablets 100 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

987 Arcalen Arnicae et Calendulae<br />

inflorescentiae extractum<br />

compositum spissum +<br />

Aesculinum<br />

Ointment (20mg +<br />

10mg)/g<br />

Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

31/12/08<br />

31/12/08<br />

31/08/05<br />

988 Archangelica comp. granulki WALA-Heilmittel GmbH 31/08/05<br />

989 Arcoxia Etoricoxibum Film-coated tablets 60 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

990 Arcoxia Etoricoxibum Film-coated tablets 90 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

991 Arcoxia Etoricoxibum Film-coated tablets 120 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

992 Ardinex Codeinum +<br />

Ibuprofenum<br />

Film-coated tablets 30mg +<br />

200mg<br />

993 Arduan Pipecuronii bromidum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Abbott GmbH & Co KG 30/04/04<br />

4 mg Gedeon Richter Ltd. 31/05/04<br />

994 Arechin Chloroquinum Tablets 250 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

995 Aredia Acidum pamidronicum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

996 Aredia Acidum pamidronicum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

997 Aredia Acidum pamidronicum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

998 Aredia Acidum pamidronicum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

30/10/05<br />

15 mg Novartis Pharma AG 30/01/05<br />

30 mg Novartis Pharma AG 12/02/06<br />

60 mg Novartis Pharma AG 31/12/08<br />

90 mg Novartis Pharma AG 31/12/08<br />

999 Arfix Nasal stick P.P.H. ‘ARF-MED’ s.c.,<br />

Koszalin<br />

1000 Argentum Complexe Lehning<br />

nr 98<br />

1001 Argentum D30/Echinacea D6<br />

aa amp.<br />

1002 ARGENTUM NITRICUM<br />

comp., ampułki<br />

1003 ARGENTUM NITRICUM<br />

comp., granulki<br />

1004 Argentum nitricum cum Kalio<br />

nitrico<br />

31/12/08<br />

Tablets Lehning Laboratoires 11/11/06<br />

WELEDA 24/08/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

ICN Polfa Rzeszów 14/07/05<br />

1005 ARGENTUM/QUARZ Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

1006 ARGENTUM/QUARZ Granules WALA-Heilmittel GmbH 24/05/07<br />

1007 ARGENTUM/-ROHRZUCKER<br />

granulki<br />

WALA-Heilmittel GmbH 19/03/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 805<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1008 ARGENTUM/-ROHRZUCKER,<br />

ampułki<br />

1009 Argentum-Dagomed 5<br />

dolegliwos´ci brzuszne<br />

WALA-Heilmittel GmbH 19/03/05<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

1010 Arginina Arginini hydrochloridum Capsules 500 mg Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

1011 Arginina L-argininum Oral powder 2,0 g ; 4,0 g Produkcyjno-Handlowe<br />

Przedsie˛biorstwo<br />

Farmaceutyków CURTIS<br />

HEEALTHCARE Sp. z.o.o.<br />

1012 Argocytromag Magnesii hydrocitras Tablets 40 mg Mg ++ ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

1013 Argogin Tablets Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

1014 Argol grip Preparat złoz˙ony Ointment ALBA THYMENT Sp. z o.o.,<br />

Poznań<br />

1015 Argol Essenza Balsamica Preparat ziołowy Liquid for external use<br />

and inhalation<br />

31/01/06<br />

26/04/06<br />

26/04/06<br />

31/01/05<br />

31/12/08<br />

31/12/08<br />

Alba Thyment 16/04/06<br />

1016 Argol rheuma Preparat złoz˙ony Ointment ALBA THYMENT Sp. z o.o.,<br />

Poznań<br />

1017 Argol® virin Preparat złoz˙ony Ointment ALBA THYMENT Sp. z o.o.,<br />

Poznań<br />

1019 Argosulfan Sulfathiazolum argentum Cream 15 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

1020 Argosulfan Sulfathiazolum argentum Cream 20 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

1018 Argosulfan Sulfathiazolum argentum Cutaneous spray 15 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

1021 Argosulfan 2 % Sulfathiazolum Cream 20 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

1022 Argotussin Dextromethorphanum<br />

1023 Argotussin Dextromethorphanum<br />

Tablets 15 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

Tablets 5 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/10/05<br />

30/04/05<br />

30/04/05<br />

1024 Aricept Donepezilum Film-coated tablets 10 mg Pfizer Bruksela 31/12/08<br />

1025 Aricept Donepezilum Film-coated tablets 5 mg Pfizer Bruksela 31/12/08<br />

1026 Arifon Indapamidum Film-coated tablets 2.5 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

1027 Arilin Rapid Metronidazolum Pessary 1000 mg Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

30/04/06<br />

31/12/08<br />

1028 Arimidex Anastrozolum Film-coated tablets 1 mg AstraZeneca UK Ltd. 31/12/08<br />

1029 Arkogelules artichaut Lab. Arkopharma 31/12/08<br />

1030 Arkogelules ginseng or<br />

ginsatonic<br />

Lab. Arkopharma 31/12/08


EN<br />

806 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1031 Arkogelules marronnierd'inde Lab. Arkopharma 31/12/08<br />

1032 Arlevert Cinnarizinum +<br />

Dimenhydrinatum<br />

Tablets 20 mg +<br />

40 mg<br />

Henning Arzneimittel GmbH 31/12/08<br />

1033 Armanor Almitrinum Film-coated tablets 50 mg Les Laboratoires Servier 31/12/04<br />

1034 Arnica complexe nr 1 Drops Lehning Laboratoires 31/03/06<br />

1035 Arnica Gel- Z˙el z arniki Preparat złoz˙ony Gel for external use Alpine Herbs Produkte AG 30/04/04<br />

1036 Arnica Ointment Preparat złoz˙ony Ointment Alpine Herbs Produkte AG 30/04/04<br />

1037 ARNICA/PLUMBUM comp A<br />

amp.<br />

1038 ARNICA/PLUMBUM comp. A,<br />

granulki<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

1039 Arnica-Heel Drops Heel GmbH 31/12/07<br />

1040 Arnica-Heel S Ointment Heel GmbH 31/12/08<br />

1041 Arnical — nalewka do uz˙ytku<br />

zewne˛trznego<br />

Preparat ziołowy Liquid Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

31/12/08<br />

1044 ARNIKA Dressing WALA-Heilmittel GmbH 24/05/07<br />

1042 ARNIKA Ointment WALA-Heilmittel GmbH 24/05/07<br />

1043 ARNIKA Tincture WALA-Heilmittel GmbH 24/05/07<br />

1045 Arnikaderm Arnicae extractum<br />

spissum + Rosmarini<br />

aetheroleum<br />

1046 Arnisol Arnicae tinctura +<br />

Gallae tinctura +<br />

Hippocastani intractum<br />

1047 Arnisol Arnicae tinctura, Gallae<br />

tinctura, Hippocastani<br />

tinctura<br />

Ointment (70 mg +<br />

30 mg)/g<br />

Coutanous liquid (730 mg +<br />

91mg +<br />

91mg)/ ml<br />

Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

Profarm — Przedsie˛biorstwo<br />

Produkcji Farmaceutyczno-<br />

Kosmetycznej Sp. z o.o.<br />

Gel Przedsie˛biorstwo Produkcji<br />

Farmaceutyczno<br />

Kosmetycznej ‘Profarm’ Sp. z<br />

o.o., Le˛bork<br />

1048 Aromagel Preparat złoz˙ony Gel fof rub Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

1049 Aromasin Exemestanum Film-coated tablets 25 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

1050 Aromatol Preparat złoz˙ony Liquid for external use<br />

and inhalation<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

1051 Aronomag Magnesii citras Film-coated tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/12/08<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

30/09/05<br />

31/01/06<br />

18/12/06<br />

1052 Arretin ICN Tretinoinum Cream 0.5 mg/g ICN Polfa Rzeszów S.A. 6/06/07<br />

1053 Arsuraneel Tablets Heel GmbH 31/12/08<br />

1054 Artecholin Preparat złoz˙ony Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

1055 Artecholwex Preparat ziołowy Tablets Herbapol Łódz´ S.A. 31/08/05<br />

1056 Arteflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

1057 Artelac Hypromellosum Eye drops, solution 3.2 mg/ml Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

30/04/05<br />

29/11/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 807<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1058 Artemisol Absinthi et Tanaceti<br />

herbae tinctura +<br />

Acidum aceticum<br />

Liquid for external use 873 mg/ml Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

1059 Arteoptic Carteololum Eye drops 1 % Novartis Ophthalmics AG<br />

Hettlingen<br />

1060 Arteoptic Carteololum Eye drops 2 % Novartis Ophthalmics AG<br />

Hettlingen<br />

31/08/05<br />

31/12/08<br />

31/12/08<br />

1061 Arteria-Heel N Drops Heel GmbH 31/12/07<br />

1062 Arthrokehlan ‘A’ D6 krople Sanum-Kehlbeck 31/12/05<br />

1063 Arthrokehlan ‘U’ D6 krople Sanum-Kehlbeck 31/12/05<br />

1064 Arthrotec Diclofenacum +<br />

Misoprostolum<br />

1065 Arthrotec Forte Diclofenacum +<br />

Misoprostolum<br />

1066 Arthryl Glucosaminum Powder for oral<br />

solution<br />

1067 Arthryl Glucosaminum Solution for<br />

intramuscular<br />

injection<br />

Tablets Searle Division of Monsanto<br />

plc.<br />

Tablets 75mg + 0,2mg Searle Division of Monsanto<br />

plc.<br />

31/12/08<br />

31/07/04<br />

1.5 g Rottapharm S.r.I 31/12/08<br />

400 mg Rottapharm S.r.I 22/02/06<br />

1068 Artrodar Diacereinum Capsules 50 mg TRB Pharma S.AWn.: Pharm<br />

Supply<br />

1069 Arytmol Drops Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

1070 Asa Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

1071 Asaltec 325 Acxidum<br />

acetylsalicylicum<br />

1072 Asasantin Retard Dipirydamolum +<br />

Acidum acetylsalicylicum<br />

1073 Ascalcin Acidum acetylsalicylicum<br />

+ Calcii lactogluconas<br />

1074 Ascalcin Plus o smaku<br />

cytrynowym<br />

1075 Ascalcin Plus o smaku<br />

grejpfrutowym<br />

Acidum acetylsalicylicum<br />

+ Acidum ascorbicum<br />

(vit C) + Calcium<br />

Acidum acetylsalicylicum<br />

+ Acidum ascorbicum<br />

(vit C) + Calcium<br />

1076 Ascodan Acidum acetylsalicylicum<br />

+ Codeinum<br />

Film-coated,<br />

gastro-resistant tablets<br />

Prolonged release<br />

capsules<br />

Effervescent tablets 300mg +<br />

100mg Ca++<br />

Effervescent powder 500mg +<br />

300mg +<br />

200mg<br />

Effervescent powder 500mg +<br />

300mg +<br />

200mg<br />

75 mg Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

325 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Boehringer Ingelheim Pharma<br />

GmbH<br />

Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

1077 Ascofer Ferrosi gluconas Coated tablets 200 mg Espefa Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

1078 Ascopir Acidum<br />

acetylsalicylicum<br />

1079 Ascorgem Acidum ascorbicum<br />

(vit C)<br />

Powder for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

30/11/05<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

23/11/05<br />

23/11/05<br />

30/10/05<br />

30/01/05<br />

VAAs Industria Chimica 31/12/08<br />

Oral drops, solution 100 mg/ml Gemi Przedsie˛biorstwo<br />

Produkcji Farmaceutycznej-<br />

Przedstawiciel<br />

26/04/06


EN<br />

808 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1080 Ascorutical Preparat złoz˙ony Capsules Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

1081 Ascorutical forte Acidum ascorbicum<br />

(vit C) + Calcium +<br />

Rutosidum<br />

Film-coated tablets 200mg +<br />

200mg +<br />

50mg<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/08/05<br />

17/01/07<br />

1082 Asentra Sertralinum Film-coated tablets 50 mg KRKA d.d., Novo mesto 12/09/07<br />

1083 Asentra Sertralinum Film-coated tablets 100 mg KRKA d.d., Novo mesto 12/09/07<br />

1084 Asmag Magnesii hydroaspartas Tablets 20 mg Mg ++ Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

1085 Asmag B Magnesii hydroaspartas<br />

+ Pyridoxinum (vit B6)<br />

Tablets 300mg +<br />

0,25mg<br />

Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

1086 Asmag forte Magnesii hydroaspartas Tablets 34 mg Mg ++ Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

1087 Asmanex Mometasoni furoas Inhalation powder 200 µg Schering — Plough Lobo<br />

N.V.<br />

1088 Asmanex Mometasoni furoas Inhalation powder 400 µg Schering — Plough Lobo<br />

N.V.<br />

31/01/06<br />

31/12/08<br />

31/01/06<br />

31/12/08<br />

31/12/08<br />

1089 Asopiryna Acidum acetylsalicylicum Tablets 0.5 g Polfarmex S.A 31/12/07<br />

1090 Asopiryna S Acidum acetylsalicylicum Tablets 0.3 g Polfarmex S.A 31/12/07<br />

1091 Asparaginase 10000 medac Asparaginasum Powder for solution<br />

for intramuscular,<br />

intravenous injection<br />

and intravenous<br />

infusion<br />

1092 Asparaginase 5000 medac Asparaginasum Powder for solution<br />

for intramuscular,<br />

intravenous injection<br />

and intravenous<br />

infusion<br />

1093 Aspargin Kalii hydroaspartas +<br />

Magnesii hydroaspartas<br />

1094 Aspargin Kalii hydroaspartas +<br />

Magnesii hydroaspartas<br />

1095 Aspargin Kalii hydroaspartas +<br />

Magnesii hydroaspartas<br />

1096 Asparginaum Asparginasum Lyophilisate for<br />

injection<br />

1097 Asparxen Kalii hydroaspartas +<br />

Magnesii hydroaspartas<br />

1098 Aspegic 1000 Acidum acetylsalicylicum Powder for oral<br />

solution<br />

1099 Aspegic 250 Acidum acetylsalicylicum Powder for oral<br />

solution<br />

1100 Aspegic 500 Acidum acetylsalicylicum Powder for oral<br />

solution<br />

1101 Aspi Acidum acetylsalicylicum Gastro-resistant<br />

tablets<br />

10000 j.m medac Gesellschaft fur<br />

Klinische Spezialpraparate<br />

mbH<br />

5000 j.m medac Gesellschaft fur<br />

Klinische Spezialpraparate<br />

mbH<br />

Tablets Espefa Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

Tablets 54mg K+ ;<br />

17mg Mg++<br />

Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

Tablets Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

Tablets 54mg K+;<br />

17mg Mg++<br />

10 000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

1000 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

250 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

500 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

325 mg US Pharmacia International,<br />

Inc.<br />

6/06/07<br />

6/06/07<br />

31/12/05<br />

31/01/06<br />

31/01/06<br />

31/12/08<br />

12/10/05<br />

31/12/04<br />

31/12/04<br />

31/12/04<br />

31/12/08<br />

1102 Aspicam Meloxicamum Tablets 7,5 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 809<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1103 Aspicam Meloxicamum Tablets 15 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

1104 Aspicard Acidum acetylsalicylicum Gastro-resistant<br />

tablets<br />

1105 Aspimag Acidum acetylsalicylicum<br />

+ Magnesii oxidum<br />

81 mg US Pharmacia International,<br />

Inc.<br />

Tablets Espefa Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

31/12/08<br />

30/09/05<br />

1107 Aspirin Acidum acetylsalicylicum Effervescent tablets 0.5 g Bayer AG 31/12/07<br />

1106 Aspirin Acidum acetylsalicylicum Tablets 500 mg Bayer AG 31/07/04<br />

1108 Aspirin 325 Acidum acetylsalicylicum Tablets 325 mg Bayer SPA 31/07/05<br />

1109 Aspirin 40 Acidum acetylsalicylicum Tablets 40 mg Bayer AG 25/01/06<br />

1110 Aspirin C Acidum acetylsalicylicum<br />

+ Acidum ascorbicum<br />

(vit C)<br />

Effervescent tablets 400mg +<br />

240mg<br />

Bayer AG 31/07/04<br />

1111 Aspirin Direkt Acidum acetylsalicylicum Buccal tablets 500 mg Bayer AG 31/12/08<br />

1112 Aspirin Protect 100 Acidum acetylsalicylicum Film-coated tablets 100 mg Bayer AG 4/10/06<br />

1113 Aspirin Protect 300 Acidum acetylsalicylicum Film-coated tablets 300 mg Bayer AG 4/10/06<br />

1114 Asprocard Acidum acetylsalicylicum<br />

+ Glycinum<br />

1115 Asprocol Acidum acetylsalicylicum<br />

+ Glycinum<br />

1116 Assalix ® Salicis cortex extractum<br />

siccum<br />

Tablets ICN Polfa Rzeszów S.A. 31/05/05<br />

Tablets ICN Polfa Rzeszów S.A. 31/12/05<br />

Coated tablets 393,24 mg Bionorica Arzneimittel GmbH 31/12/08<br />

1117 Assimilaid Preparat złoz˙ony Capsule Sunrider Manufacturing L.P.,<br />

USA<br />

1118 Astemizol Astemizolum Tablets 10 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

1119 Astemizol Astemizolum Tablets 10 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1120 Asthma H Homoopatisches<br />

Laboratorium A.Pfluger<br />

1122 Astmopent Orciprenalinum Solution for injection 0.5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

1121 Astmopent Orciprenalinum Spray 0.75 mg/dawke˛ GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

31/03/05<br />

31/03/05<br />

1123 Atacand Candesartanum Tablets 16 mg AstraZeneca AB 31/08/04<br />

1124 Atacand Candesartanum Tablets 4 mg AstraZeneca AB 31/08/04<br />

1125 Atacand Candesartanum Tablets 8 mg AstraZeneca AB 31/08/04<br />

1128 Atarax Hydroxyzinum Film-coated tablets 10 mg UCB S.A. Pharma Sector 30/09/04<br />

1129 Atarax Hydroxyzinum Film-coated tablets 25 mg UCB S.A. Pharma Sector 30/09/04<br />

1126 Atarax Hydroxyzinum Solution for<br />

intramuscular<br />

injection<br />

50 mg/ml UCB S.A. Pharma Sector 30/09/04<br />

1127 Atarax Hydroxyzinum Syrup 2 mg/ml UCB S.A. Pharma Sector 30/09/04


EN<br />

810 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1130 Atecortin Hydrocortisonum +<br />

Oxytetracyclinum +<br />

Polymyxinum B<br />

Ear and eye drops,<br />

suspension<br />

(15mg + 5mg<br />

+ 1000j.m.)/ml<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

1131 Atehexal 25 Atenololum Film-coated tablets 25 mg Hexal AG 31/12/08<br />

1133 Atenolol Atenololum Film-coated tablets 100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

1134 Atenolol Atenololum Film-coated tablets 50 mg Norton Healthcare Ltd. 30/06/04<br />

1132 Atenolol Atenololum Tablets 50 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12/02/06<br />

1135 Atenolol Atenololum Tablets 50 mg Aflofarm 31/12/08<br />

1136 Atenolol Atenololum Tablets 25 mg Aflofarm 31/12/08<br />

1137 Atenolol 100 Atenololum Tablets 100 mg Sanofi-Synthelabo Sp. z o.o. 30/11/05<br />

1138 Atenolol 12,5 Atenololum Tablets 12,5 mg Sun — Farm Sp. z o.o. 31/12/08<br />

1139 Atenolol 25 Atenololum Tablets 25 mg Sanofi-Synthelabo Sp. z o.o. 22/09/05<br />

1140 Atenolol 25 Atenololum Tablets 25 mg Sun — Farm Sp. z o.o. 31/12/08<br />

1141 Atenolol 50 Atenololum Tablets 50 mg Sanofi-Synthelabo Sp. z o.o. 30/09/05<br />

1142 Atgam Immunoglobulina<br />

limfocytarna globulina<br />

antytymocytom<br />

1143 ATG-Fresenius S Antilymphocyte<br />

immunoglobulin (horse)<br />

1144 ATG-Fresenius S Antilymphocyte<br />

immunoglobulin (horse)<br />

1145 Atlan'tol AV5 Formaldehyd,<br />

glutaraldehyd,<br />

isopropanol<br />

1146 Atlan'tol Mamelo-1 dwuglukonian<br />

chloroheksydyny,<br />

alkohol izopropylowy<br />

glicerol<br />

Solution for<br />

intravenous injection<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

Liquid for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

50 mg/ml Pharmacia & Upjohn Co. 30/06/07<br />

20 mg/ml Fresenius HemoCare Immune<br />

Therapy GmbH<br />

20 mg/ml Fresenius HemoCare Immune<br />

Therapy GmbH<br />

31/12/07<br />

31/12/07<br />

Atlan'tol NV 31/12/08<br />

Atlan'tol NV 31/12/08<br />

1147 Atoris Atorvastatinum Film-coated tablets 10 mg KRKA Polska Sp. z o.o. 31/12/08<br />

1148 Atoris Atorvastatinum Film-coated tablets 20 mg KRKA Polska Sp. z o.o. 31/12/08<br />

1149 Atorvastatin Atorvastatinum Film-coated tablet 10 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/12/08<br />

1151 Atorvastatin Atorvastatinum Film-coated tablets 10 mg POL-NIL Sp. z.o.o. 31/12/08<br />

1152 Atorvastatin Atorvastatinum Film-coated tablets 20 mg POL-NIL Sp. z.o.o. 31/12/08<br />

1150 Atorvastatin Atorvastatinum Tablets PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

1153 Atorvastatin Atrovastatinum Film-coated tablets 40 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/12/08<br />

31/12/08<br />

1154 Atorvastin Atorvastatinum Film-coated tablets 10 mg POLFA KUTNO S.A. 31/12/08<br />

1155 Atorvastin Atorvastatinum Film-coated tablets 20 mg POLFA KUTNO S.A. 31/12/08<br />

1156 Atorvastin Atorvastatinum Film-coated tablets 40 mg POLFA KUTNO S.A. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 811<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1157 Atorvastin Atorvastatinum Film-coated tablets 20 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

1158 Atorwastatyna Atorvastatinum Tablets 20 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

1159 Atorwastatyna Atorvastatinum Tablets 10 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

1161 Atossa Ondansetronum Film-coated tablets 4 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

1162 Atossa Ondansetronum Film-coated tablets 8 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

1160 Atossa Ondansetronum Solution for injection 2 mg/ml Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

1163 Atrederm 0,025 % Tocopherolum +<br />

Tretinoinum<br />

1164 Atrederm 0,05 % Tocopherolum +<br />

Tretinoinum<br />

1165 Atrederm 0,1 % Tocopherolum +<br />

Tretinoinum<br />

1166 Atrobac 3 Szczepionka przeciw<br />

róz˙ycy i zakaz´nemu<br />

zanikowemu zapaleniu<br />

nosa dla s´wiń<br />

Coutanous liquid Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Coutanous liquid 0.05 % Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Coutanous liquid Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Suspension for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/07<br />

30/04/06<br />

30/04/06<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

Pfizer 25/11/04<br />

1167 Atrocor Atorvastatinum Film-coated tablets 10 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

1168 Atrocor Atorvastatinum Film-coated tablets 20 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/12/08<br />

31/12/08<br />

1169 Atropinum compositum Amp. Heel GmbH 31/12/08<br />

1170 Atropinum Compositum S Suppository Heel GmbH 31/12/08<br />

1171 Atropinum sulfuricum Atropinum Solution for injection 0.5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

1172 Atropinum sulfuricum Atropinum Solution for injection 1 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

1173 Atropinum sulfuricum 1 % Atropinum Eye drops, solution 10 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

1174 Atropiny siarczan BUFA b.v. Pharmaceutical<br />

Products<br />

1175 Atropiny siarczan Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

14/12/05<br />

14/12/05<br />

31/01/06<br />

30/11/05<br />

30/11/05<br />

1176 Atropiny siarczan Pharma Cosmetic, Kraków 30/11/05<br />

1177 Atropiny siarczan Pharma Zentrale 30/11/05<br />

1178 Atropiny siarczan PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

1179 Atrovent Ipratropii bromidum Nasal spray, solution 21 mcg/dawke˛<br />

donosowa˛<br />

1180 Atrovent Ipratropii bromidum Nasal spray, solution 42 mcg/dawke˛<br />

donosowa˛<br />

Boehringer Ingelheim<br />

International GmbH<br />

Boehringer Ingelheim<br />

International GmbH<br />

30/11/05<br />

5/07/06<br />

5/07/06


EN<br />

812 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1183 Atrovent Ipratropii bromidum Nebuliser solution 0.25 mg/ml Boehringer Ingelheim<br />

International GmbH<br />

1181 Atrovent Ipratropii bromidum Pressurised inhalation,<br />

suspension<br />

1182 Atrovent Ipratropii bromidum Pressurised inhalation,<br />

suspension<br />

1184 Atrovent®N Ipratropii bromidum Pressurised inhalation,<br />

solution<br />

0.02 mg/dawke˛ GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

20 mcg/dawke˛ Boehringer Ingelheim<br />

International GmbH<br />

20 mcg Boehringer Ingelheim<br />

International GmbH<br />

30/01/05<br />

30/10/05<br />

31/05/04<br />

31/12/08<br />

1185 Atrox 10 Atorvastatinum Film-coated tablets 10 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

1186 Atrox 20 Atorvastatinum Film-coated tablets 20 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

1187 Atrox 40 Atorvastatinum Film-coated tablets 40 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

1188 Atrozol Anastrozolum Film-coated tablets 1mg VIPHARM S.A. Warszawa 31/12/08<br />

1197 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1198 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1199 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1200 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1190 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1191 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1192 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1193 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1194 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1195 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1196 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1189 Augmentin Acidum clavulanicum +<br />

Amoxicillinum<br />

1201 AUGMENTIN 2 g + 0,2 g Amoxicillinum +<br />

Acidum clavulanicum<br />

1202 Aujesyva 6-S Inaktywowana<br />

szczepionka dla s´wiń<br />

przeciwko chorobie<br />

Aujeszky'ego<br />

Film-coated tablets 1g SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

Film-coated tablets 125mg +<br />

250mg<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Film-coated tablets 625mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

Film-coated tablets 375mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

Powder for oral<br />

suspension<br />

Powder for oral<br />

suspension<br />

Powder for oral<br />

suspension<br />

Powder for solution<br />

for intravascular<br />

injection<br />

Powder for solution<br />

for intravascular<br />

injection<br />

Powder for solution<br />

for intravascular<br />

injection and infusion<br />

Powder for solution<br />

for intravascular<br />

injection and infusion<br />

Powder for<br />

suspension<br />

Powder for solution<br />

for intravenous<br />

injection and infusion<br />

156 mg/5ml SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

(31mg +<br />

125mg)/5ml<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

457 mg/5 ml SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

200mg + 1g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

100mg +<br />

500mg<br />

Suspension for veterinary<br />

use<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1,2g SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

600 mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

312.5 mg/5ml SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

30/06/07<br />

30/10/05<br />

11/07/05<br />

30/04/04<br />

30/04/04<br />

30/10/05<br />

31/07/04<br />

30/10/05<br />

30/10/05<br />

30/04/04<br />

30/04/04<br />

31/12/04<br />

2 g + 0,2 g SmithKline Beecham 31/12/08<br />

Laboratorios SYVA, S.A. 14/11/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 813<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1203 Aujinflu Suivax inaktywowana<br />

szczepionka<br />

adsorbowana<br />

wodorotlenkiem dlinu<br />

przeciwko chorbie<br />

Aujeszk'y i grypie s´wiń<br />

1204 Aulin Nimesulidum Granules for oral<br />

suspension<br />

Suspension for veterinary<br />

use<br />

Fatro 31/12/08<br />

100 mg Medicom International s.r.o. 31/05/04<br />

1205 Aulin Nimesulidum Tablets 100 mg Medicom International s.r.o. 31/05/04<br />

1206 Aurex 20 Citalopranum Film-coated tablets 20 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

1207 Aurex 30 Citalopranum Film-coated tablets 30 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

1208 Aurex 40 Citalopranum Film-coated tablets 40 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

1209 Aurex 60 Citalopranum Film-coated tablets 60 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

1210 Aurikan Prednizolon,<br />

Heksamidyna,<br />

Tetrakainy<br />

chlorowodorek, Lindan<br />

Ear drops for veterinary<br />

use<br />

1211 Aurofac 100 Chlortetracyclinum Powder for veterinary<br />

use<br />

1212 Aurofac 100G chlorowodorek<br />

chlortetracykliny<br />

Granules for veterinary<br />

use<br />

Ceva Sante Animale 9/06/04<br />

Alpharma AS 30/06/04<br />

Alpharma 31/12/08<br />

1213 AURONAL 10 mg Felodipinum Film-coated tablets 10 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

1214 AURONAL 2,5 mg Felodipinum Film-coated tablets 2,5 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

1215 AURONAL 5 mg Felodipinum Film-coated tablets 5 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

1216 Aurorix Moclobemidum Film-coated tablets 150 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

1217 Aurorix Moclobemidum Film-coated tablets 300 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

31/05/04<br />

31/05/04<br />

1218 AURUM comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

1219 AURUM comp. granulki WALA-Heilmittel GmbH 19/03/05<br />

1220 AURUM comp. ung. WALA-Heilmittel GmbH 19/03/05<br />

1221 Aurum jodatum Pentarkan H Tablets DHU-Arzneimittel GmbH &<br />

Co.KG<br />

1222 AURUM/BELLADONNA<br />

comp.<br />

1223 AURUM/BELLADONNA<br />

comp.<br />

19/03/06<br />

Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

Granules WALA-Heilmittel GmbH 24/05/07<br />

1224 AURUM/REGINA comp. Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

1225 AURUM/REGINA comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

1226 AURUM/STIBIUM/-<br />

HYOSCYAMUS amp.<br />

1<strong>227</strong> AURUM/STIBIUM/-<br />

HYOSCYAMUS gran.<br />

1228 AURUM/VALERIANA comp.<br />

amp.<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05


EN<br />

814 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1229 AURUM/VALERIANA comp.<br />

granulki<br />

WALA-Heilmittel GmbH 19/03/05<br />

1230 Aurumheel N Drops Heel GmbH 31/12/07<br />

1231 Auskipra — GN/A3 z˙ywa szczepionka dla<br />

s´wiń przeciwsko<br />

chorbie aujeszky'ego<br />

1232 Avaden — 1 Estradiolum +<br />

Gestodenum<br />

1233 Avaden — 2 Estradiolum +<br />

Gestodenum<br />

Lyophilisate for veterinary<br />

use<br />

Hipra 31/12/08<br />

Film-coated tablets Schering AG 31/12/08<br />

Film-coated tablets Schering AG 31/12/08<br />

1234 Avandia Rosiglitazonum Film-coated tablets 1 mg SmithKline Beecham plc 14/12/05<br />

1235 Avandia Rosiglitazonum Film-coated tablets 2 mg SmithKline Beecham plc 14/12/05<br />

1236 Avandia Rosiglitazonum Film-coated tablets 4 mg SmithKline Beecham plc 14/12/05<br />

1237 Avandia Rosiglitazonum Film-coated tablets 8 mg SmithKline Beecham plc 14/12/05<br />

1238 Avatec 15 % Lazalocidu sól sodowa Granules for veterinary<br />

use<br />

1239 Avaxim Hepatitis A, inactivated,<br />

whole virus<br />

Suspension for<br />

intramuscular<br />

injection<br />

1240 Avelox Moxifloksacinum Solution for<br />

intravenous infusion<br />

Alpharma AS 20/05/04<br />

0.5 ml Aventis Pasteur S.A. 31/12/08<br />

1,6 mg/ml Bayer AG 30/11/04<br />

1241 Avelox Moxifloxacinum Film-coated tablets 400 mg Bayer AG 30/11/04<br />

1243 Avenoc Ointment Laboratoires BOIRON 9/01/06<br />

1242 Avenoc Suppository Laboratoires BOIRON 9/01/06<br />

1244 Avi Pro Precise z˙ywa szczepionka<br />

przeciwko zakaz´nemu<br />

zapaleniu torby<br />

fabrycjusza ibd<br />

Lyophilisate for veterinary<br />

use<br />

1245 Aviax semduramycyna Premix for veterinary<br />

use<br />

1246 Aviffa-RTI Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

nosa i tchawicy<br />

indyków oraz<br />

syndromowi wielkiej<br />

głowy kur<br />

Lyophilisate for veterinary<br />

use<br />

1247 Avimetronid Metronidazolum Tablets for veterinary<br />

use<br />

1248 Avimetronid Metronidazolum Powder for veterinary<br />

use<br />

1249 Avinew Z˙ywa szczepionki dla<br />

kur przeciw<br />

rzekomemu pomorowi<br />

drobiu<br />

Lyophilisate for veterinary<br />

use<br />

Lohmann Animal Health<br />

International<br />

31/12/08<br />

Phibro 31/12/08<br />

Merial 24/02/05<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne Polfa<br />

31/12/08<br />

24/05/04<br />

Merial SAS 4/06/07<br />

1250 Aviomarin Dimenhydrinatum Solution for injection 50 mg/1 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

1251 Aviomarin Dimenhydrinatum Tablets 50 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/05<br />

30/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 815<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1252 Aviomarin Mitte Dimenhydrinatum Tablets 25 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

1253 Avioplant Zingiberis rhizomae Capsules 350 mg Phytopharm Kle˛ka S.A. 31/12/08<br />

1254 Avir-tonic Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

1255 Avituberculin Białko tuberkulinowe z<br />

przesa˛czu hodowli<br />

Mycobacterium avium<br />

D4ER<br />

Liquid for veterinary<br />

use<br />

1256 Avonex Interferonum beta-1a Powder and solvent<br />

for solution for<br />

intramuscular<br />

injection<br />

30 mcg (6 mln<br />

j.m.)<br />

31/12/08<br />

Biowet Puławy 31/12/08<br />

Biogen B.V. 31/01/05<br />

1257 Awirol Aciclovirum Cream 50 mg/g Instytut Farmaceutyczny 30/10/05<br />

1258 Awirol Aciclovirum Cream 50 mg/g ICN Polfa Rzeszów S.A. 23/11/06<br />

1259 Azactam Aztreonamum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1260 Azactam Aztreonamum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

0.5 g Bristol-Myers Squibb S.p.A. 30/04/04<br />

1 g Bristol-Myers Squibb S.p.A. 30/04/04<br />

1261 Azadinum Loratadinum Tablets 10 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

1262 Azathioprine Azathioprinum Tablets 50 mg Norton Healthcare Ltd. 30/06/04<br />

1263 Azathioprine Azathioprinum Tablets 50 mg VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

Bytom<br />

31/12/05<br />

1268 Azibiot Azithromycinum Film-coated tablets 500 mg KRKA Polska Sp. z o.o. 31/12/08<br />

1264 Azibiot Azithromycinum Powder for oral<br />

suspension<br />

1265 Azibiot Azithromycinum Powder for oral<br />

suspension<br />

1266 Azibiot Azithromycinum Powder for oral<br />

suspension<br />

1267 Azibiot Azithromycinum Powder for oral<br />

suspension<br />

150 mg KRKA Polska Sp. z o.o. 31/12/08<br />

200 mg KRKA Polska Sp. z o.o. 31/12/08<br />

250 mg KRKA Polska Sp. z o.o. 31/12/08<br />

500 mg KRKA Polska Sp. z o.o. 31/12/08<br />

1270 Azimycin Azithromycinum Film-coated tablets 125 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1271 Azimycin Azithromycinum Film-coated tablets 250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1272 Azimycin Azithromycinum Film-coated tablets 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1269 Azimycin Azithromycinum Granules for solution 100mg /5ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1273 Azimycin Granules for oral<br />

solution<br />

200 mg /5ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

1274 Azitrex Azitromycinum Film-coated tablets 500 mg Expharm Inc. 31/12/08


EN<br />

816 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1275 Azitrin Azithromycinum Tablets 125 mg ,<br />

250 mg ,<br />

500 mg<br />

GENEXO Sp.z.o.o Warszawa 31/12/08<br />

1276 Azitrox 250 Azithromycinum Film-coated tablets 250 mg Leciva a.s. 31/12/08<br />

1277 Azitrox 500 Azithromycinum Film-coated tablets 500 mg Leciva a.s. 31/12/08<br />

1278 Azlocillin Azlocillinum Powder for solution<br />

for intravascular<br />

injection<br />

1279 Azlocillin Azlocillinum Powder for solution<br />

for intravascular<br />

injection<br />

1280 Azmacort Triamcinolonum Spray 100 mcg/<br />

dawke˛<br />

1 g Pharmachim-Holding AD 31/07/04<br />

5 g Pharmachim-Holding AD 31/07/04<br />

Rhone-Poulenc-Rorer<br />

Pharmaceuticals Inc.<br />

31/12/08<br />

1281 Azopt Brinzolamidum Eye drops, suspension 10 mg/ml Alcon Laboratoires UK Ltd. 14/12/05<br />

1282 Azovir Zidovudinum Capsules 100 mg ICN Polfa Rzeszów S.A. 19/04/06<br />

1283 Azovir Zidovudinum Capsules 250 mg ICN Polfa Rzeszów S.A. 19/04/06<br />

1284 Azucalen Liquid for irrigation Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

1285 Azulan Chamomillae anthodium<br />

extractum<br />

1286 Azulan Chamomillae anthodium<br />

extractum<br />

Cutaneous and<br />

mucosa membrane<br />

liquid<br />

Cutaneous and<br />

mucosa membrane<br />

liquid<br />

1287 Azulan Cutaneous and<br />

mucosa membrane<br />

liquid<br />

31/08/05<br />

Phytopharm Kle˛ka S.A. 31/08/05<br />

Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/08/05<br />

31/08/05<br />

1288 Azupentat — 400 Retard Pentoxifyllinum Film-coated tablets 400 mg Biochemie GmbH — Kundl 31/07/04<br />

1289 Azuseptol Chamomillae anthodium Liquid Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

1290 Azycyna Azithromycinum Film-coated tablets 500 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

1291 Azycyna Azithromycinum Film-coated tablets 250 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

1292 Azylid Azithromycinum Film-coated tablets 500 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

1293 B12 Ankermann Cyanocobalaminum Solution for injection 100 mcg/ml Wörwag Pharma GmbH<br />

Co.KG<br />

1294 B12 Ankermann Cyanocobalaminum Solution for injection 1000 mcg/ml Wörwag Pharma GmbH<br />

Co.KG<br />

1295 B12 Ankermann Cyanocobalaminum Solution for injection 1000 mcg/ml Wörwag Pharma GmbH<br />

Co.KG<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/01/05<br />

31/01/05<br />

31/01/05<br />

1296 Babicum Syrup 320 mg/5ml N.P. Pharma Sp. z o.o. 21/11/06<br />

1297 Babka lanc. Fix Herb Herbapol — Białostok S.A. 10/05/06<br />

1298 Baby Orajel Benzocainum Oromucosal gel 75 mg/g Del Pharmaceuticals INC 30/04/04<br />

1299 Baclofen Baclofenum Tablets 10 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 817<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1300 Baclofen Baclofenum Tablets 25 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

1301 Bacolam Amoksicillinum +<br />

Colistinum<br />

1302 Bacolam Injectable Amoxicillunum +<br />

Colistinum<br />

Powder for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

30/10/05<br />

Fatro S.p.A. 30/01/06<br />

Fatro S.p.A. 5/01/06<br />

1303 Bactiflox 250 Ciprofloxacinum Film-coated tablets 250 mg Mepha L.D.A. 31/12/08<br />

1304 Bactiflox 500 Ciprofloxacinum Film-coated tablets 500 mg Mepha L.D.A. 31/12/08<br />

1305 Bactiflox 750 Ciprofloxacinum Film-coated tablets 750 mg Mepha L.D.A. 31/12/08<br />

1306 Bactrazol Trimethoprimum +<br />

Sulfamethoxazolum<br />

1307 Bactrim Sulfamethoxazolum +<br />

Trimethoprimum<br />

1308 Bactrim Sulfamethoxazolum +<br />

Trimethoprimum<br />

1309 Bactrim Sulfamethoxazolum +<br />

Trimethoprimum<br />

1310 Bactrim Forte, Bactrim Sulfamethoxazolum +<br />

Trimethoprimum<br />

Oral suspension Krakowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Solution for<br />

intravenous infusion<br />

96 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

Syrup 240 mg/5ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

Tablets 480 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

Tablets 960 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

1311 Bactroban Mupirocinum Cream 20 mg/g SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

1313 Bactroban Mupirocinum Nasal ointment 20 mg/g SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

1312 Bactroban Mupirocinum Ointment 20 mg/g SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

31/12/08<br />

31/07/04<br />

31/07/04<br />

31/07/04<br />

31/12/04<br />

13/10/05<br />

9/05/05<br />

13/10/05<br />

1314 Badiaga Complexe Nr 47 Tablets Lehning Laboratoires 31/12/08<br />

1315 Baifem bajkalina Gel preparat<br />

złoz˙ony<br />

1316 Baikadent Scutellariae baicalensis<br />

radix extractum<br />

1317 Baikaderm bajkalina, alantoina Ointment preparat<br />

złoz˙ony<br />

1318 Baikanin Capsule, hard preparat<br />

złoz˙ony<br />

1319 Baldex Theophyllinum +<br />

Guaifenesinum<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Oromucosal gel 5.77 mg/g Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

Syrup (50mg +<br />

30mg)/5ml<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

31/12/08<br />

15/03/06<br />

31/12/08<br />

31/12/08<br />

28/02/06<br />

1320 Baldrian mono Coated tablets 190 mg Rottendorf Pharma GmbH 31/12/08<br />

1321 Baldriparan Coated tablets Rottendorf Pharma GmbH 31/12/08<br />

1322 Balneum Hermal Oleum Sojae Bath additive 847.5 mg/g Boots Healthcare<br />

International<br />

1323 Balneum Hermal F Oleum Arachidis +<br />

Paraffinum liquidum<br />

1324 Balneum-Hermal Plus Oleum Sojae +<br />

Polidocanolum<br />

Bath additive Boots Healthcare<br />

International<br />

Bath additive Boots Healthcare<br />

International<br />

27/06/06<br />

31/12/06<br />

31/12/04<br />

1325 Balsam peruwiański A.C.E.F., Włochy 31/12/08


EN<br />

818 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1326 Balsam peruwiański BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08<br />

1327 Balsam peruwiański Farm-Impex s.j., Gliwice 31/12/08<br />

1328 Balsam peruwiański Pharma Cosmetic, Kraków 31/12/08<br />

1329 Balsam peruwiański Pharma Zentrale 31/12/08<br />

1330 Balsam peruwiański PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

1331 Balsam Szostakowskiego<br />

(Vinilinum)<br />

31/12/08<br />

Liquid ICN POLYPHARM 31/07/04<br />

1332 Balsam S´ wia˛tynia Niebios Ointment Zhonghua Pharmaceuticals<br />

Factory<br />

1333 Balsamum Mentholi<br />

Compositum<br />

Methylis salicylas +<br />

Mentholum<br />

Ointment (200mg +<br />

25mg)/g<br />

Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

1334 Balsolan Balsamum peruvianum Ointment 100 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

1335 Balsolan A Ointment Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

1336 Bals-Sulphur z˙el Preparat złoz˙ony Gel Sulphur Zdrój Exim —<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/01/05<br />

31/01/06<br />

10/01/05<br />

31/12/08<br />

31/05/05<br />

1337 Bambec Bambuterolum Tablets 10 mg AstraZeneca AB 6/09/06<br />

1338 Bambec Bambuterolum Tablets 20 mg AstraZeneca AB 6/09/06<br />

1339 Bancid Praziquantelum Solution for veterinary<br />

use<br />

1340 Baneocin Bacitracinum +<br />

Neomycinum<br />

Ointment (250 j.m. +<br />

5mg)/g<br />

1341 Banminth pasta dla koni Pyrantelu embonian Paste for veterinary<br />

use<br />

1342 Banminth pasta dla kotów Embonian pyrantelu Paste for veterinary<br />

use<br />

1343 Banminth pasta dla psów Embonian pyrantelu Paste for veterinary<br />

use<br />

CP-Pharma 31/12/08<br />

Biochemie GmbH — Kundl 30/09/04<br />

Pfizer 31/12/07<br />

Pfizer 31/12/08<br />

Pfizer 31/12/08<br />

1344 Barijodeel Tablets Heel GmbH 31/12/08<br />

1345 Barium sulfuricum Barii sulfas Oral suspension 1 g/ml Medana Pharma Terpol<br />

Group S.A.<br />

31/01/06<br />

1346 Basiron Benzoili peroxydum Gel Laboratoires Galderma 31/12/08<br />

1347 Basiron Benzoili peroxydum Gel Laboratoires Galderma 31/12/08<br />

1348 Basiron Benzoili peroxydum Gel Laboratoires Galderma 31/12/08<br />

1351 Batrafen Ciclopiroxum Coutanous liquid 10 mg/ml Hoechst Marion Roussel<br />

Deutschland GmbH<br />

1349 Batrafen Ciclopiroxum Cream 10 mg/ml Hoechst Marion Roussel<br />

Deutschland GmbH<br />

1350 Batrafen Ciclopiroxum Nail lacquer 80 mg/g Hoechst Marion Roussel<br />

Deutschland GmbH<br />

30/04/04<br />

30/06/04<br />

26/07/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 819<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1352 Baycox 2,5 % Toltrazuril Solution for veterinary<br />

use<br />

1353 Baycox 5 % toltrazuril Suspension for veterinary<br />

use<br />

1354 Baycuten Clotrimazolum +<br />

Dexamethasonum<br />

1355 Baymec Iwermektyna Solution for veterinary<br />

use<br />

1356 Bayofly Pour-On Cyflutryna Solution for veterinary<br />

use<br />

1357 Bayovac BRSV + PI3 Szczepionka dla bydła<br />

przeciwko zakaz˙eniom<br />

RSV oraz PI3<br />

1358 Baypamun HK Preparat immunostymuluja˛cy<br />

dla psów i<br />

kotów<br />

1359 Baypamun P Preparat immunostymuluja˛cy<br />

dla koni<br />

Bayer AG 5/05/07<br />

Biowet Puławy 31/12/08<br />

Cream 1 % + 0,04 % Bayer AG 31/12/08<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

1360 Baypamune Immunostymulator Lyophilisate + solvent for veterinary<br />

use<br />

1361 Baypen Mezlocillinum Powder for solution<br />

for intravascular<br />

injection and infusion<br />

1362 Baypen Mezlocillinum Powder for solution<br />

for intravascular<br />

injection and infusion<br />

1363 Baypen Mezlocillinum Powder for solution<br />

for intravascular<br />

injection and infusion<br />

Bayer 31/12/08<br />

Bayer AG 5/03/06<br />

Bayer Niemcy 31/12/08<br />

Bayer 26/01/05<br />

Bayer 6/02/05<br />

Bayer Niemcy 30/09/07<br />

0.5 g Bayer AG 30/04/04<br />

2 g Bayer AG 30/04/04<br />

5 g Bayer AG 30/04/04<br />

1364 Baypress Nitrendipinum Tablets 20 mg Bayer AG 31/07/04<br />

1365 Baytril 0,5 % Enrofloxacinum Solution for veterinary<br />

use<br />

1366 Baytril 10 % Enrofloxacinum Solution for veterinary<br />

use<br />

1367 Baytril 10 % Enrofloxacinum Solution for veterinary<br />

use<br />

1368 Baytril 15 mg Enrofloxacinum Tablet for veterinary<br />

use<br />

1369 Baytril 150 mg Enrofloxacinum Tablet for veterinary<br />

use<br />

1370 Baytril 2,5 % inj. Enrofloxacinum Solution for veterinary<br />

use<br />

1371 Baytril 5 % (Baytril 5 % inj.) Enrofloxacinum Solution for veterinary<br />

use<br />

1372 Bayvarol Flumetryna Bee- hive strip for veterinary<br />

use<br />

Bayer 30/01/05<br />

Bayer 30/01/05<br />

Bayer 31/12/08<br />

Bayer AG 8/11/05<br />

Bayer AG 8/11/05<br />

Bayer 8/11/05<br />

Bayer 31/12/08<br />

Bayer AG 5/03/06<br />

1373 BC 56 Preparat złoz˙ony Cream Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

1374 BCG — Medac Vaccinum BCG powder and solvent<br />

for suspension for<br />

intrabladder use<br />

medac Gesellschaft für<br />

klinische Spezialpräparate<br />

mbH<br />

31/12/08<br />

31/12/08


EN<br />

820 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1375 Beaphar — obroz˙a dla kota Tetrachlorwinfos Collar for veterinary<br />

use<br />

1376 Beaphar — obroz˙a dla psa Tetrachlorwinfos Collar for veterinary<br />

use<br />

Beaphar BV 15/05/07<br />

Beaphar BV 15/05/07<br />

1377 Bebilon Amino Dieta eliminacyjna Powder Nutricia Cuijk B.V 31/12/07<br />

1378 Bebilon BMF Dodatek do mleka<br />

kobiecego<br />

1380 Bebilon Nenatal Prep. odz˙ywczy dla<br />

wczes´niaków<br />

1379 Bebilon Nenatal Prep. odz˙ywczy dla<br />

wczes´niaków<br />

1381 Bebilon Pepti Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

1382 Bebilon Pepti 1, Bebilon Pepti Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

1383 Bebilon Pepti 2 Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

1384 Bebilon Pepti MCT Dieta eliminacyjna z<br />

MCT<br />

1385 Bebilon sojowy 1 Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

1386 Bebilon sojowy 2 Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

1387 Beclazone EB Beclometasonum Pressurised inhalation,<br />

solution<br />

1388 Beclazone EB Beclometasonum Pressurised inhalation,<br />

solution<br />

1389 Beclazone EB Beclometasonum Pressurised inhalation,<br />

suspension<br />

1390 Beclazone EB Beclometasonum Pressurised inhalation,<br />

suspension<br />

1391 Beclazone EB Beclometasonum Pressurised inhalation,<br />

suspension<br />

1392 Beclocort mite Beclometasonum Pressurised inhalation,<br />

suspension<br />

1393 Beclocort forte Beclometasonum Pressurised inhalation,<br />

suspension<br />

1394 Beclomet Beclometasonum Pressurised inhalation,<br />

suspension<br />

Powder Nutricia Cuijk B.V 31/12/07<br />

Liquid N.V. Nutricia 31/12/07<br />

Powder diet Nutricia Cuijk B.V 31/12/08<br />

Alimentation liquid N.V. Nutricia 31/12/07<br />

Powder Nutricia Cuijk B.V 31/12/07<br />

Powder Nutricia Cuijk B.V 30/09/05<br />

Powder Nutricia Cuijk B.V 30/06/06<br />

Powder Nutricia Cuijk B.V 30/06/07<br />

Powder Nutricia Cuijk B.V 31/03/04<br />

100 mcg/<br />

dawke˛<br />

250 mcg/<br />

dawke˛<br />

100 mcg/<br />

dawke˛<br />

250 mcg/<br />

dawke˛<br />

Norton Waterford Ltd. 11/10/06<br />

Norton Waterford Ltd. 11/10/06<br />

Norton Ltd. 30/09/04<br />

Norton Ltd. 30/09/04<br />

50 mcg/dawke˛ Norton Ltd. 30/09/04<br />

50 mcg/dawke˛<br />

inhalacyjna˛<br />

250 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/12/05<br />

31/12/05<br />

50 mcg/dawke˛ Orion Corporation 30/06/04<br />

1395 Beclomet Nasal Beclometasonum Nasal spray 50 mcg/dawke˛ Orion Corporation 30/06/04<br />

1396 Becodisk Beclometasonum Inhalation powder 100 mcg/<br />

dawke˛<br />

1397 Becodisk Beclometasonum Inhalation powder 200 mcg/<br />

dawke˛<br />

1398 Beconase Beclometasonum Nasal spray, water<br />

suspension<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

50 mcg/dawke˛ Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

30/06/04<br />

30/06/04<br />

30/11/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 821<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1399 Becotide Beclometasonum Pressurised inhalation,<br />

suspension<br />

1400 Bedicort Betamethasonum +<br />

Acidum salicylicum<br />

1401 Bedicort A Bathametasonum +<br />

Acidum salicylicum<br />

1402 Bedicort G Betamethasonum +<br />

Gentamicinum<br />

1403 Bedicort G Betamethasonum +<br />

Gentamicinum<br />

1404 Begrivac Influenza, inactivated,<br />

whole virus<br />

50 mcg/dawke˛<br />

inhalacyjna˛<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Liquid 0,5 mg +20 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Ointment preparat<br />

złoz˙ony<br />

Cream (0,5mg +<br />

1mg)/g<br />

Ointment (0,5mg +<br />

1mg)/g<br />

Suspension for<br />

injection<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/06/04<br />

31/12/08<br />

31/12/08<br />

15/03/06<br />

15/03/06<br />

0.5 ml Chiron Behring GmbH & Co. 30/06/07<br />

1405 Bekunis Coated tablets Roha Arzneimittel GmbH 31/12/08<br />

1406 Belcospira Orale Collistinum +<br />

Spiramycinum<br />

1407 BELLADONNA/<br />

CHAMOMILLA<br />

Powder for veterinary<br />

use<br />

Merial 30/06/04<br />

Granules WALA-Heilmittel GmbH 24/05/07<br />

1408 Belladonna-Homaccord Amp. Heel GmbH 31/12/07<br />

1409 Belladonna-Homaccord Drops Heel GmbH 31/12/07<br />

1410 Bellapan Atropinum Tablets 0.25 mg Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

1411 Bellergot Atropinum +<br />

Ergotaminum +<br />

Phenobarbitalum<br />

Film-coated tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/01/06<br />

30/01/05<br />

1412 Beloderm Betamethasonum Cream 0,5 mg/g Belupo Ltd. 31/12/08<br />

1413 Beloderm Betamethasonum Ointment 0,5 mg/g Belupo Ltd. 31/12/08<br />

1414 Belogent Bethamethasonum +<br />

Gentamycinum<br />

1415 Belogent Bethamethasonum +<br />

Gentamycinum<br />

1417 Belosalic Betamethasonum +<br />

Acidum salicylicum<br />

1416 Belosalic Betamethasonum +<br />

Acidum salicylicum<br />

Cream Belupo Ltd. 31/12/08<br />

Ointment Belupo Ltd. 31/12/08<br />

Coutanous liquid (0,5 mg +<br />

30 mg)/g<br />

Ointment (0,5 mg +<br />

30 mg)/g<br />

Belupo Ltd. 31/12/08<br />

Belupo Ltd. 31/12/08<br />

1418 Bemecor Metildigoxinum Oral drops, solution 0.6 mg/1 ml Lek Pharmaceuticals d.d. 30/06/04<br />

1419 Bemecor Metildigoxinum Solution for injection 0.1 mg/ml Lek Pharmaceuticals d.d. 30/06/04<br />

1420 Bemecor Metildigoxinum Tablets 0.1 mg Lek Pharmaceuticals d.d. 30/06/04<br />

1421 Ben Gay Children's Camphorum +<br />

Mentholum<br />

1422 Ben Gay Greaseless/Stainless<br />

Ointment<br />

Methylis salicylas +<br />

Mentholum<br />

1423 Ben Gay Sports Balm Methylis salicylas +<br />

Mentholum<br />

Ointment (50mg +<br />

40mg)/g<br />

Ointment (150mg +<br />

100mg)/g<br />

Ointment (280mg +<br />

100mg)/g<br />

Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

30/06/04<br />

30/06/04<br />

30/06/04


EN<br />

822 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1424 Benalapril 10 Enalapilum Tablets 10 mg BERLIN — CHEMIE AG<br />

(Menarini Group)<br />

1425 Benalapril 20 Enalapilum Tablets 20 mg BERLIN — CHEMIE AG<br />

(Menarini Group)<br />

1426 Benalapril 5 Enalaprili maleas Tablets 5 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

1427 Benalgin Benzydamini<br />

hydrochloridum<br />

1428 Benalgin Benzydamini<br />

hydrochloridum<br />

1429 Benalpharm Coffeinum +<br />

Metamizolum natricum<br />

+ Thiaminum (vit B1)<br />

31/12/08<br />

31/12/08<br />

30/06/04<br />

Cream 30 mg/g Sanofi-Synthelabo Sp. z o.o. 31/12/05<br />

Film-coated tablets 50 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05<br />

Tablets Pharmachim-Holding AD 31/12/08<br />

1430 Benfogamma Benfothiaminum Coated tablets 50 mg Wörwag Pharma GmbH<br />

Co.KG<br />

14/12/05<br />

1431 Benuron Paracetamolum Suppository 1 g Bene Arzneimittel GmbH 31/03/07<br />

1432 Benuron Paracetamolum Suppository 125 mg Bene Arzneimittel GmbH 31/01/05<br />

1433 Benuron Paracetamolum Suppository 250 mg Bene Arzneimittel GmbH 31/01/05<br />

1434 Benuron Paracetamolum Suppository 500 mg Bene Arzneimittel GmbH 31/12/04<br />

1435 Benuron Paracetamolum Syrup 200 mg/5ml Bene Arzneimittel GmbH 31/12/04<br />

1436 Benuron Paracetamolum Tablets 0.5 g Bene Arzneimittel GmbH 30/04/04<br />

1437 Benzacne Benzoylis peroxydum Gel 100 mg/g Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

1438 Benzacne Benzoylis peroxydum Gel 50 mg/g Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

1439 Benzapur Benzoili peroxydum Cutaneous gel 50 mg / g Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

1440 Benzapur Benzoylis peroxydum Gel 100 mg/g Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

1441 Benzocainum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/05<br />

31/12/05<br />

31/01/06<br />

31/01/06<br />

18/01/06<br />

1442 Benzylopenicylina prokainowa Scholz, Sowin 31/01/06<br />

1443 Benzyna Benzinum Galenus, Rzeszów 31/12/08<br />

1444 Benzyna Benzinum Pharma Zentrale 31/12/08<br />

1445 Benzyna Benzinum Zakład Farmaceutyczny<br />

Amara, Kraków<br />

31/12/08<br />

1446 Bepanthen Dexpanthenolum Cream 50 mg/g Roche Consumer Health Ltd 30/04/04<br />

1447 Bepanthen Dexpanthenolum Ointment 50 mg/g Roche Consumer Health Ltd 30/04/04<br />

1448 Bepanthen Lotion Dexpanthenolum Coutanous liquid 25 mg/g Roche Consumer Health Ltd 30/04/04<br />

1449 Bepanthen Plus Cream Chlorhexidinum +<br />

Dexpanthenolum<br />

1450 Bepepsin Betainii hydrochloridum<br />

+ Pepsinum<br />

Cream Hoffmann La Roche Ltd.<br />

Bazylea<br />

Tablets 400mg +<br />

100mg<br />

Cefarm Gdańsk<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

4/10/06<br />

31/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 823<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1451 Berberil Tetryzolinum Eye drops 0.5 mg/ml Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

1452 Berberis Complexe Lehning<br />

nr 83<br />

1453 BERBERIS E FRUCTIBUS<br />

comp., ampułki<br />

1454 BERBERIS E FRUCTIBUS<br />

comp., granulki<br />

4/07/07<br />

Drops Lehning Laboratoires 11/11/06<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

1455 Berberis Similiaplex krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

1456 BERBERIS/PROSTATA comp.,<br />

ampułki<br />

1457 BERBERIS/PROSTATA comp.,<br />

granulki<br />

30/11/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

1458 BERBERIS/QUARZ Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

1459 BERBERIS/QUARZ Granules WALA-Heilmittel GmbH 24/05/07<br />

1460 BERBERIS/URTICA URENS Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

1461 BERBERIS/URTICA URENS Granules WALA-Heilmittel GmbH 24/05/07<br />

1462 BERBERIS/UTERUS comp.<br />

ampułki<br />

1463 BERBERIS/UTERUS comp.<br />

granulki<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

1464 Berberis-Homaccord Amp. Heel GmbH 31/12/08<br />

1465 Berberis-Homaccord Drops Heel GmbH 31/12/08<br />

1466 Beriate P 1000 Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

1467 Beriate P 250 Lyophilisate and<br />

solvent for solution<br />

for injection and<br />

intravascular infusion<br />

1468 Beriate P 500 Lyophilisate and<br />

solvent for solution<br />

for injection and<br />

intravascular infusion<br />

1000 j.m. Centeon Pharma GmbH 31/08/05<br />

250 j.m. Centeon Pharma GmbH 31/08/05<br />

500 j.m. Centeon Pharma GmbH 31/08/05<br />

1469 Beriplast P Set for tissular glue Centeon Pharma GmbH 31/07/04<br />

1470 Beriplex P/N 250 Lyophilisate and<br />

solvent for solution<br />

for intravascular<br />

injection and<br />

intravascular infusion<br />

1471 Beriplex P/N 500 Lyophilisate and<br />

solvent for solution<br />

for intravascular<br />

injection and<br />

intravascular infusion<br />

250 j.m.<br />

Czynnika IX<br />

500 j.m.<br />

Czynnika IX<br />

Centeon Pharma GmbH 31/10/04<br />

Centeon Pharma GmbH 31/10/04<br />

1472 Berocca Ca, Mg, Zn Effervescent tablets Roche Polska Sp. z o.o. 31/10/05<br />

1473 Berocca Ca, Mg, Zn Film-coated tablets Roche Polska Sp. z o.o. 31/10/05


EN<br />

824 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1476 Berodual Fenoterolum + Ipratropii<br />

bromidum<br />

1474 Berodual Fenoterolum + Ipratropii<br />

bromidum<br />

1475 Berodual Fenoterolum + Ipratropii<br />

bromidum<br />

1477 Berodual N Fenoterolum + Ipratropii<br />

bromidum<br />

Nebuliser solution Boehringer Ingelheim<br />

International GmbH<br />

Pressurised inhalation (50mcg +<br />

20mcg)/ dawke˛<br />

inhalacyjna˛<br />

Pressurised inhalation,<br />

suspension<br />

Pressurised inhalation,<br />

solution<br />

1480 Berotec Fenoterolum Inhalation solution 0.1 % (1 mg/<br />

1 ml)<br />

1478 Berotec Fenoterolum Pressurised inhalation,<br />

suspension<br />

1479 Berotec Fenoterolum Pressurised inhalation,<br />

suspension<br />

1481 Berotec N 100 Fenoterolum Pressurised inhalation,<br />

solution<br />

1482 Bestpirin Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

1483 Bestpirin Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

1484 Bestpirin Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

200mcg/dawke˛<br />

inhalacyjna˛<br />

200 mcg/<br />

dawke˛<br />

100 mcg/<br />

dawke˛<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Boehringer Ingelheim<br />

International GmbH<br />

Boehringer Ingelheim<br />

International GmbH<br />

Boehringer Ingelheim<br />

International GmbH<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Boehringer Ingelheim<br />

International GmbH<br />

Boehringer Ingelheim<br />

International GmbH<br />

30 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

325 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

75 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/05/04<br />

30/10/05<br />

31/05/04<br />

6/12/06<br />

31/10/05<br />

31/12/05<br />

31/05/04<br />

6/11/05<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

1485 Beta Carotene Betacarotenum Capsules, soft 15 mg PRO NATURA s.j. 31/12/08<br />

1486 Beta Karoten Betacarotenum Capsules 6 mg Puritan's Pride, Incorporated 31/07/04<br />

1487 Betabion Betaxololum Eye drops, solution 5 mg/ml Bioton Sp. z o.o. 14/03/07<br />

1490 Betadine Povidone-iodine Liquid for hands<br />

disinfection<br />

75 mg/ml Egis Pharmaceuticals Ltd. 31/03/05<br />

1489 Betadine Povidone-iodine Ointment 100 mg/g Egis Pharmaceuticals Ltd. 28/11/05<br />

1488 Betadine Povidone-iodine Pessary 200 mg Egis Pharmaceuticals Ltd. 23/10/06<br />

1491 Betadine Povidone-iodine Solution for external<br />

use<br />

1493 Betadrin Diphenhydraminum +<br />

Naphazolinum<br />

1492 Betadrin Diphenhydraminum +<br />

Naphazolinum<br />

Eye drops, solution (1mg +<br />

0,33mg)/ml<br />

Nasal drops, solution (1mg +<br />

0,33mg)/ml<br />

1494 Betaferon Interferonum beta — 1 b Powder and solvent<br />

for solution for<br />

subcutanoeus<br />

injection<br />

1495 Betaferon Interferonum beta-1b Powder and solvent<br />

for solution for<br />

injection<br />

100 mg/ml Egis Pharmaceuticals Ltd. 31/07/05<br />

0,25 mg<br />

(8 mln j.m.)<br />

0.3 mg<br />

(9,6 mln j.m.)<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05<br />

31/12/05<br />

Schering AG 31/12/08<br />

Schering AG 31/12/08<br />

1496 Betaghistine Dihydrochloride Betahistinum Tablets 16 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

1497 Betagran Herbal granules Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

31/12/08<br />

31/08/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 825<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1498 Betahistine Dihyrdochloride Betahistinum Tablets 8 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

1499 Beta-Karoten Betacarotenum Tablets 10 mg Chance — Zakład Produkcji<br />

Chemiczno —<br />

Farmaceutycznej s.c.<br />

1500 Beta-Karoten + Witamina E Betacarotenum +<br />

Tocopherolum<br />

1501 Beta-Karoten 25.000 j.m. z<br />

witaminami C i E<br />

Acidum ascorbicum<br />

(vit C) + Betacarotenum<br />

+ Tocopherolum<br />

1502 Beta-Karoten E Betacarotenum +<br />

Tocopherolum<br />

1503 Betaklav Amoxicillinum +<br />

Acidum clavulanicum<br />

1504 Betaklav Amoxicillinum +<br />

Acidum clavulanicum<br />

1505 BETAKLAV Duo Amoxicillinum +<br />

Acidum clavulanicum<br />

Capsules, soft 7 mg + 25mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/12/08<br />

30/06/05<br />

31/01/05<br />

Film-coated tablets C.E. Jamieson Co. Ltd 31/07/04<br />

Tablets Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

Powder for oral<br />

suspension<br />

(250 mg +<br />

62,5 mg)/g<br />

Tablets 500 mg +<br />

125 mg<br />

Tablets 875 mg +<br />

125 mg<br />

31/01/05<br />

KRKA d.d., Novo mesto 31/12/08<br />

KRKA d.d., Novo mesto 31/12/08<br />

KRKA d.d., Novo mesto 31/12/08<br />

1506 Betaloc Metoprololi tartas Solution for injection 1 mg/ml AstraZeneca AB 30/06/04<br />

1507 Betaloc ZOK 50 Metoprololum Controled release<br />

tablets<br />

1508 Betaloc ZOK 100 Metoprololum Controled release<br />

tablets<br />

1509 Betaloc ZOK 200 Metoprololum Controled release<br />

tablets<br />

1510 Betaloc ZOK 25 Metoprololum Controled release<br />

tablets<br />

50 mg AstraZeneca AB 31/12/08<br />

100 mg AstraZeneca AB 31/12/07<br />

200 mg AstraZeneca AB 31/12/07<br />

23,75mg AstraZeneca AB 15/11/06<br />

1511 Betamann Metipranololum Eye drops, solution 1 mg/ml Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

1512 Betamann Metipranololum Eye drops, solution 3 mg/ml Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

30/01/05<br />

30/01/05<br />

1513 Betamann 0,3 % Edo Metipranololum Eye drops 3 mg/ml Dr Gerhard Mann 31/12/08<br />

1514 Betamox 200 Amoxicillunum Tablets for veterinary<br />

use<br />

1515 Betamox 40 Amoxicillunum Tablets for veterinary<br />

use<br />

1516 Betamox L.A. Amoxicillunum Suspension for veterinary<br />

use<br />

Norbrook 31/12/08<br />

Norbrook 31/12/08<br />

Norbrook 18/03/04<br />

1517 Betaserc Betahistinum Tablets 16 mg Solvay Pharmaceuticals B.V. 30/11/04<br />

1518 Betaserc Betahistinum Tablets 8 mg Solvay Pharmaceuticals B.V. 16/08/05<br />

1519 Betasol Oral solution Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

1519 Betasol Oral solution Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

31/08/05<br />

31/08/05


EN<br />

826 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1520 Betmaethasone Dipropioniate,<br />

Clotrimazolum, Gantamicin<br />

Sulfate<br />

1521 Betmaethasone Dipropioniate,<br />

Clotrimazolum, Gantamicin<br />

Sulfate<br />

Betamethasonum +<br />

Clotrimazolum +<br />

Gentamicinum<br />

Betamethasonum +<br />

Clotrimazolum +<br />

Gentamicinum<br />

Cream 0,5 mg, 10mg,<br />

1mg<br />

Ointment 0,5 mg, 10mg,<br />

1mg<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

1522 Betnesol Betamethasonum Solution for injection 4 mg/1 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

1523 Betnovate Betamethasonum Cream 1.22 mg/g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

1524 Betnovate Betamethasonum Ointment 1.22 mg/g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

1525 Betnovate Betamethasonum Solution for haired<br />

head skin<br />

1526 Betnovate C Betamethasonum +<br />

Clioquinolum<br />

1527 Betnovate C Betamethasonum +<br />

Clioquinolum<br />

1528 Betnovate N Betamethasonum +<br />

Neomycinum<br />

1529 Betnovate N Betamethasonum +<br />

Neomycinum<br />

Cream (1.22 mg +<br />

30mg)/g<br />

Ointment (1.22 mg +<br />

30mg)/g<br />

Cream (1.22 mg +<br />

5 mg)/g<br />

Ointment (1.22 mg +<br />

5 mg)/g<br />

1.22 mg/g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

1530 Betolol Sotalolum Tablets 40 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1531 Betolol Sotalolum Tablets 80 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

30/06/04<br />

31/08/04<br />

31/08/04<br />

31/08/04<br />

31/08/04<br />

31/08/04<br />

31/08/04<br />

31/08/04<br />

31/12/08<br />

31/12/08<br />

1532 Betoptic 0,5 % Betaxololum Eye drops 5 mg/ml Alcon Couvreur N.V. 30/06/04<br />

1533 Betoptic S Betaxololum Eye drops 2.5 mg/ml Alcon Couvreur N.V. 30/06/04<br />

1534 BETULA/ARNICA comp.<br />

ampułki<br />

1535 BETULA/ARNICA comp.<br />

granulki<br />

1536 Bezalip retard Bezafibratum Film-coated, prologed<br />

release tablets<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

400 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

1537 Bezamidin Bezafibratum Film-coated tablets 200 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/05/04<br />

30/11/05<br />

1538 Biafine Cutaneous emulsion Laboratoire Medix Houdan 31/12/08<br />

1539 Biflor Tablets 3 mld pałeczek<br />

kwasu<br />

mlekowego<br />

US Pharmacia 31/12/08<br />

1540 Bifluorid 12 Dental lacquer VOCO GmbH 31/12/07<br />

1541 Bigopest Szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu oskrzeli,<br />

rzekomemu pomorowi<br />

drobiu i chorobie<br />

Gumboro<br />

1542 Bihelminth prazikwantel,<br />

fenbendazol<br />

Emulsion for veterinary<br />

use<br />

Tablets for veterinary<br />

use<br />

Merial 30/06/04<br />

Riemser 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 827<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1543 Biherpan Heparinum natricum +<br />

Zinci sulfas<br />

1544 Bilberin Myrtilli fructus extractum<br />

siccum<br />

1545 Bilberin Myrtilli fructus extractum<br />

siccum, Betacarotenum<br />

Gel (300 j.m. +<br />

10mg)/g<br />

Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

Capsules, soft 200 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Oral capsules Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

1546 Biliaroten — fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp. z<br />

o.o. — Zastawna<br />

1547 Biliepar Acidum<br />

ursodeoxycholicum<br />

1548 Bilobase Gonkgo bilboae<br />

extractum, Cholina,<br />

Inositol<br />

1549 Bilobi l forte Ginkgo bilobae folium<br />

extractum siccum<br />

Capsules 0.15 g Instituto Bioterapico<br />

Nazionale (I.BIR.N.) S.R.L.<br />

Film-coated tablets preparat<br />

złoz˙ony<br />

31/05/05<br />

31/07/05<br />

31/07/05<br />

31/08/05<br />

31/07/04<br />

US Pharmacia 31/12/08<br />

Capsules 80 mg KRKA, d.d., Novo mesto 31/12/08<br />

1550 Bilobil Ginkgo biloba Capsules 40 mg Krka d.d., Novo mesto 29/02/04<br />

1551 Bilocol Osalmidum Coated tablets 250 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

1552 Bimanol Deanolum Tablets 100 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

1553 Binat Natrii hydrocarbonas Tablets 500 mg Menagement and Consulting<br />

Group<br />

1554 Binazin Todralazini<br />

hydrochloridum<br />

1555 Binewgodrop Szczepionka przeciw<br />

rzekomemu pomorowi<br />

drobiu, zakaz´nemu<br />

zapaleniu oskrzeli i<br />

syndromowi spadku<br />

nies´nos´ci i chorobie<br />

Gumboro dla kur<br />

1556 Binewvaxidrop Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli kur,<br />

rzekomemu pomorowi<br />

drobiu i syndromowi<br />

spadku nies´nos´ci<br />

1557 Bio — Sept Fluorescenian sodu,<br />

z˙ółcień metanilowa,<br />

formaldehyd<br />

1558 Bio Ava Szczepionka przeciw<br />

reowirusowemu<br />

zapaleniu stawów dla<br />

kur<br />

1559 Bio Cholera Szczepionka dla kur i<br />

indyków przeciw<br />

pasterelozie<br />

1560 Bio Reo 1 Szczepionka<br />

przeciwko<br />

reowirusowemu<br />

zapaleniu stawów u<br />

kur<br />

Tablets 20 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

Emulsion for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

31/01/06<br />

31/12/05<br />

11/10/06<br />

31/12/05<br />

Merial 30/06/04<br />

Merial 10/05/04<br />

Przedsie˛biorstwo Tropical 31/12/08<br />

Merial Italia SPA s.s. 31/12/08<br />

Merial Italia SPA 22/05/06<br />

Merial Italia SPA s.s. 31/12/08


EN<br />

828 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1561 Bio Reo 2 Szczepionka<br />

przeciwko<br />

reowirusowemu<br />

zapaleniu stawów u<br />

kur<br />

Lyophilisate for veterinary<br />

use<br />

Merial Italia SPA s.s. 31/12/08<br />

1562 Bioaron C Preparat złoz˙ony Syrup Phytopharm Kle˛ka S.A. 30/10/05<br />

1563 Bioascovit Acidum ascorbicum Powder for veterinary<br />

use<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

1564 Bioaspirinol Acidum acetylsalicylicum Suppository 0,500 g Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z.o.o Lublin<br />

1565 Bioaspirinol Acidum acetylsalicylicum Suppository 0,300 g Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z.o.o Lublin<br />

1566 Biocan B szczepionka przeciwko<br />

boreliozie u psów<br />

1567 Biocan DHPPi szczepionka przeciw<br />

nosówce, zakaz´nemu<br />

zapaleniu wa˛troby,<br />

zakaz´nemu zapaleniu<br />

górnych dróg<br />

oddechowych,<br />

parwowirozie i<br />

parainfluenzie psów<br />

1568 Biocan LR inaktywowana<br />

szczepionka przeciw<br />

leptospirozie i<br />

ws´ciekliz´nie u psów i<br />

zwierza˛t futerkowych<br />

1569 Biocan R inaktywowana<br />

szczepionka przeciwko<br />

ws´ciekliz´nie<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Bioveta a.s. 31/12/08<br />

Bioveta a.s. 31/12/08<br />

Bioveta a.s. 31/12/08<br />

Bioveta a.s. 31/12/08<br />

1570 Biocardine 900 Olej z mie˛s´ni ryb Capsules 900 mg Scandinavian Laboratories,<br />

USA<br />

1571 Biocefazon Cefoperazonum Dry substance for<br />

injection and infusion<br />

1572 Biocefazon Cefoperazonum Dry substance for<br />

injection and infusion<br />

1573 Biocefazon Cefoperazonum Dry substance for<br />

injection and infusion<br />

1574 BIO-COX 120G Salinomycyny sól<br />

sodowa<br />

Premix for veterinary<br />

use<br />

1575 Biodacyna Amikacinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

1576 Biodacyna Amikacinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

31/12/08<br />

0.5 g Bioton Sp. z o.o. 31/12/08<br />

1 g Bioton Sp. z o.o. 31/12/08<br />

2 g Bioton Sp. z o.o. 31/12/08<br />

Alpharma AS 29/06/06<br />

125 mg/ml Instytut Biotechnologii i<br />

Antybiotyków<br />

30/10/05<br />

250 mg/ml Bioton Sp. z o.o. 30/10/05<br />

1577 Biodacyna ophtalmicum 0,3 % Amikacinum Eye drops 3 mg/ml Bioton Sp. z o.o. 31/12/05<br />

1578 Biodent Toothpaste Lek Pharmaceuticals d.d. 31/08/05<br />

1579 Biodribin Cladribinum Solution for<br />

intravenous infusion<br />

1 mg/ml Instytut Biotechnologii i<br />

Antybiotyków<br />

30/06/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 829<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1583 Biodroxil Cefadroxilum Capsules 500 mg Biochemie GmbH — Kundl 31/12/08<br />

1584 Biodroxil Cefadroxilum Film-coated tablets 1 g Biochemie GmbH — Kundl 31/12/08<br />

1580 Biodroxil Cefadroxilum Granules for oral<br />

solution<br />

1581 Biodroxil Cefadroxilum Granules for oral<br />

solution<br />

1582 Biodroxil Cefadroxilum Granules for oral<br />

solution<br />

1585 Biodylon Fortius Mesulfen Solution for veterinary<br />

use<br />

1586 Biodylon Mitius Mesulfen Solution for veterinary<br />

use<br />

1588 Bioepicyna Epirubicinum Lyophilisate for<br />

solution for injection<br />

1587 Bioepicyna Epirubicinum Lyophilisate for<br />

solution for injection<br />

1589 Bioestrovet Kloprostenol Liquid for veterinary<br />

use<br />

1590 Biofast Neomycinum +<br />

Polymyxinum B<br />

Sulfatum +Bacitracinum<br />

Ointment praparat<br />

złoz˙ony<br />

1591 Biofazolin Cefazolinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1592 Biofazolin Cefazolinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

125 mg/5ml Biochemie GmbH — Kundl 31/12/08<br />

250 mg/5ml Biochemie GmbH — Kundl 31/12/08<br />

500 mg/5ml Biochemie GmbH — Kundl 31/12/08<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

30/06/04<br />

24/05/04<br />

10 mg Bioton Sp. z o.o. 31/12/05<br />

50 mg Instytut Biotechnologii i<br />

Antybiotyków<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

31/12/05<br />

9/06/04<br />

31/12/08<br />

1 g Bioton Sp. z o.o. 31/01/05<br />

500 mg Bioton Sp. z o.o. 31/01/05<br />

1593 Biofenak Diclofenacum Suppository 0,100 g Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z.o.o Lublin<br />

1594 Bioflax Lini semen Powder for oral<br />

suspension<br />

1595 Bioflumeq Flumechina, We˛glan<br />

sodu bezwodny,<br />

laktoza<br />

Granules for veterinary<br />

use<br />

1596 Biofungin Pvidene-Iodine Gel for veterinary<br />

use<br />

1600 Biofuroksym Cefuroximum Powder for solution<br />

for intravascular<br />

injection<br />

1598 Biofuroksym Cefuroximum Powder for solution<br />

for intravenous and<br />

intramuscular<br />

injection or for<br />

suspension for<br />

intramuscular<br />

injection<br />

4g Instytut Włókien<br />

Naturalnych, Poznań<br />

Zakłady Farmaceutyczne ‘<br />

Biowet’ Sp. z o.o.<br />

31/12/08<br />

31/12/08<br />

9/06/04<br />

Biowet Drwalew 31/12/08<br />

1.5 g Bioton Sp. z o.o. 30/10/05<br />

250 mg Bioton Sp. z o.o. 31/12/08


EN<br />

830 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1599 Biofuroksym Cefuroximum Powder for solution<br />

for intravenous and<br />

intramuscular<br />

injection or for<br />

suspension for<br />

intramuscular<br />

injection<br />

1597 Biofuroksym Cefuroximum Powder for solution<br />

for intravenous<br />

injection and for<br />

suspension for<br />

intramuscular<br />

injection<br />

1601 Biogal Boraginis officinalis<br />

oleum<br />

500 mg Bioton Sp. z o.o. 31/12/08<br />

750 mg Bioton Sp. z o.o. 30/10/05<br />

Capsules 350 mg Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

31/12/08<br />

1602 Biogastrin Bismuthi subcitras Capsules 147,8 mg Multi Pharma Sweden AB 31/12/08<br />

1603 Bioginko Ginkgo bilobae<br />

extractum sicc., Panax<br />

ginseng extractum sicc.<br />

1604 Bioglobulina Immunoglobulinum<br />

humanum<br />

1605 Biogonadyl 2000 Gonadotrophinum<br />

chorionicum<br />

1606 Biogonadyl 500 Gonadotrophinum<br />

chorionicum<br />

1607 Biogonadyl 5000 Gonadotrophinum<br />

chorionicum<br />

Film-coated tablets 50 mg +<br />

50 mg<br />

Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

infusion<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

P.T. Indofarma 31/12/08<br />

50 mg/ml Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

2000 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

500 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

5000 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

1608 Biohical 120 Calcii fumaras Tablets 120 mg Ca2+ Farmaceutyczny Zakład<br />

Naukowo — Produkcyjny<br />

‘BIOCHEFA’<br />

30/09/05<br />

31/01/06<br />

31/01/06<br />

31/01/05<br />

31/12/08<br />

1609 Biohyalan Natrii hyaluronas Amp-syringe 10 mg Biofactor Polska 31/12/08<br />

1610 Biohyalan Natrii hyaluronas Solution for articular<br />

injection<br />

10 mg Biofactor Polska 31/12/08<br />

1611 Biohyalaza Hyaluronidazum Lyophylisate 500 j. Biofactor Polska 31/12/08<br />

1612 Biohyalaza Hyaluronidazum Lyophylisate 1000 j. Biofactor Polska 31/12/08<br />

1613 Bioi Q 100 Olej z mie˛s´ni ryb Capsules 100 mg Scandinavian Laboratories,<br />

USA<br />

1614 Bioketan Ketaminum Solution for veterinary<br />

use<br />

1615 Biolactin Prolaktyna s´wińska Lyophilisate + solvent for veterinary<br />

use<br />

1616 Biolecitin Lecytyna, witamina e,<br />

olej wiesiołkowy, olej<br />

lniany<br />

1617 Biolent Forte Karbaminocholiny<br />

chlorek<br />

Liquid for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

31/12/08<br />

31/12/08<br />

Biochefa 18/07/04<br />

Biowet Puławy 31/12/08<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

17/08/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 831<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1618 Biolugol Kalii iodum + Iodum Liquid for veterinary<br />

use<br />

1619 Biomag Glycinum + Magnesii<br />

lactas<br />

1620 Bio-Marek HVT Szczepionka dla<br />

kurcza˛t przeciw<br />

chorobie Mareka<br />

1621 Bio-Marek HVT frozen Szczepionka przeciw<br />

chorobie Mareka dla<br />

piskla˛t<br />

1622 Biomarine 570 Samnosi microcephali<br />

oleum<br />

1623 Biomarine 1140 Samnosi microcephali<br />

oleum<br />

1624 Biomast Zawiesina<br />

drobnoustrojów<br />

coryne bacterium<br />

uberis<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

10/06/04<br />

Film-coated tablets 30 mg Mg ++ Sanofi-Synthelabo Sp. z o.o. 31/12/05<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

FATRO 18/08/04<br />

FATRO 15/10/04<br />

Capsules 570 mg Scandinavian Laboratories<br />

Inc., USA<br />

Capsules 1140 mg Scandinavian Laboratories<br />

Inc., USA<br />

Suspension for veterinary<br />

use<br />

1625 Biomectin 1 % Iwermektyna Solution for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

Abiotest 31/12/08<br />

Zakłady Farmaceutyczne<br />

‘Biowet’<br />

1626 Biometamizol Metamizolum Tablet 0,5 g BIOMED Wytwórnia Surowic<br />

i Szczepionek Spółka z o.o.<br />

1627 Biometamizol 0,300 Metamizolum Suppository 0,300 g Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z.o.o Lublin<br />

1628 Biometamizol 0,750 Metamizolum Suppository 0,750 g Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z.o.o Lublin<br />

1629 Biomox Amoxicillunum Powder for veterinary<br />

use<br />

1630 Biomox 80 Amoxicillunum Powder for veterinary<br />

use<br />

1631 Biomutin 10 % premix Tiamulina Premix for veterinary<br />

use<br />

1632 Biomutin 10 % premix Tiamuliny<br />

wodorofumaran<br />

1633 Biomutin 20 % inj. Tiamuliny<br />

wodorofumaran<br />

1634 Biomutin 45 % pulvis Tiamuliny<br />

wodorofumaran<br />

1635 Biomutin ot Wodorofumaran<br />

tiamuliny,<br />

oksytetracyklina<br />

1636 Biomycyn Bacitracinum +<br />

Neomycinum<br />

Premix for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Podwer for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet Sp. z o.o.<br />

Zakłady Farmaceutyczne<br />

Biowet Sp. z o.o.<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego S.A.<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego S.A.<br />

4/01/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

9/06/04<br />

9/06/04<br />

31/12/08<br />

23/10/06<br />

20/06/05<br />

20/06/05<br />

Biowet Drwalew 31/12/08<br />

Biowet Drwalew 31/12/08<br />

1637 Biopancreatin 10 000 Pancreatinum Capsules 150 mg Biofactor Polska 31/12/08<br />

1638 Biopancreatin 20 000 Pancreatinum Capsules 300 mg Biofactor Polska 31/12/08


EN<br />

832 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1639 Bioparox Fusafunginum Nasal and oromucosal<br />

spray<br />

0.125 mg/<br />

dawke˛<br />

Les Laboratoires Servier 30/09/04<br />

1641 Bioprazol Omeprazolum Capsuels, hard 20 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

1640 Bioprazol Omeprazolum Capsules, hard 10 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

10/05/06<br />

10/05/06<br />

1642 Bioprost Capsules, soft 160 mg P.T. Indofarma 8/02/06<br />

1643 Bioquyl 10 % Flumechina Solution for veterinary<br />

use<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego Spółka<br />

Akcyjna<br />

9/11/05<br />

1645 Bioracef Cefuroximum Film-coated tablets 125 mg Bioton Sp. z o.o. 7/06/05<br />

1646 Bioracef Cefuroximum Film-coated tablets 250 mg Bioton Sp. z o.o. 7/06/05<br />

1647 Bioracef Cefuroximum Film-coated tablets 500 mg Bioton Sp. z o.o. 7/06/05<br />

1644 Bioracef Cefuroximum Powder for oral<br />

suspension<br />

1648 Bioral H 120 Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli dla kur<br />

Lyophilisate for veterinary<br />

use<br />

1649 Biorelina WET Busereliny octan Solution for veterinary<br />

use<br />

1651 Biorubina Doxorubicinum Lyophilisate for<br />

solution for injection<br />

1650 Biorubina Doxorubicinum Lyophilisate for<br />

solution for<br />

intravenous injection<br />

and blader infusion<br />

125 mg Bioton Sp. z o.o. 7/06/05<br />

Merial 30/06/04<br />

Biochefa 1/08/04<br />

10 mg Instytut Biotechnologii i<br />

Antybiotyków<br />

50 mg Instytut Biotechnologii i<br />

Antybiotyków<br />

1652 Biosalvit Film-coated tablets Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1653 Bio-Sept Forte Fluoresceina , z˙ółcień<br />

metanilowa, aldehyd<br />

mrówkowy<br />

Solution for veterinary<br />

use<br />

31/12/05<br />

12/10/05<br />

30/06/05<br />

Przedsiebiorstwo Tropical 18/09/07<br />

1655 Bioseryl Extractum sanquicum Solution for infusion 1000 mg Biofactor Polska 31/12/08<br />

1654 Bioseryl Extractum sanquicum Vial 100 mg Biofactor Polska 31/12/08<br />

1656 Biosol 70 % Neomycinum Powder for veterinary<br />

use<br />

1657 Biosol -M Neomycyny siarczan,<br />

Bromek<br />

metyloskopola-miny<br />

Solution for veterinary<br />

use<br />

Pharmacia N.V./S.A. 31/12/08<br />

Pharmacia N.V./S.A. 4/05/04<br />

1658 Biosotal 160 Sotalolum Tablets 160 mg Sanofi-Synthelabo Sp. z o.o. 19/07/05<br />

1659 Biosotal 40 Sotalolum Tablets 40 mg Sanofi-Synthelabo Sp. z o.o. 19/07/05<br />

1660 Biosotal 80 Sotalolum Tablets 80 mg Sanofi-Synthelabo Sp. z o.o. 19/07/05<br />

1661 Biostate Czynnik krzepnie˛cia VIII<br />

ludzki<br />

Powder for solution<br />

for intravenous<br />

injection<br />

500 j.m. CSL Bioplasma 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 833<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1662 Biostate Czynnik krzepnie˛cia VIII<br />

ludzki<br />

Powder for solution<br />

for intravenous<br />

injections<br />

250 j.m. CSL Bioplasma 31/12/08<br />

1663 Biosten Acidum alendronicum Tablets 5 mg Polfarmex S.A. 31/12/08<br />

1664 Biosten Acidum alendronicum Tablets 10 mg Polfarmex S.A. 31/12/08<br />

1665 Biosteron Dehydroepiandrosteronum<br />

1666 Biosteron Dehydroepiandrosteronum<br />

1667 Biosteron Dehydroepiandrosteronum<br />

1668 Biostymina Aloe arborescens<br />

extractum<br />

1669 Biosul Solutio Sulphadiazinum +<br />

Trimethoprimum<br />

1670 Biosurfact — 100 Surfactanum Lyophilisated<br />

substance<br />

1671 Biosurfact — 5000 Surfactanum Lyophilisated<br />

substance<br />

1672 Biotab Biotyna, metionina,<br />

vitamina b6<br />

Tablets 10 mg Lek-AM Sp. z o.o.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Tablets 25 mg LE-AM Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

Tablets 5 mg Lek-AM Sp. z o.o.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

29/08/07<br />

29/08/07<br />

29/08/07<br />

Solution for injection 1 ml Phytopharm Kle˛ka S.A. 31/08/05<br />

Solution for veterinary<br />

use<br />

Tablets for veterinary<br />

use<br />

1673 Biotaksym Cefotaximum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1674 Biotaksym Cefotaximum Powder for solution<br />

for intravascular and<br />

intramuscular<br />

injection<br />

1675 Biotaksym Cefotaximum Powder for solution<br />

for intravascular and<br />

intramuscular<br />

injection<br />

1676 Biotox Deltametryna Suspension for veterinary<br />

use<br />

1678 Biotrakson Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1679 Biotrakson Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1680 Biotrakson Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1677 Biotrakson Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

Biowet Drwalew 31/12/08<br />

100 mg Biofactor Polska 31/12/08<br />

5000 mg Biofactor Polska 31/12/08<br />

Biowet Puławy 31/12/08<br />

1 g Bioton Sp. z o.o. 30/10/05<br />

250 mg Bioton Sp. z o.o. 30/11/05<br />

500 mg Bioton Sp. z o.o. 30/11/05<br />

Biowet Drwalew 31/12/08<br />

1 g Bioton Sp. z o.o. 30/10/05<br />

250 mg Bioton Sp. z o.o. 31/12/08<br />

500 mg Bioton Sp. z o.o. 31/12/08<br />

2 g Bioton Sp. z o.o. 30/10/05


EN<br />

834 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1681 Biotrim solutio Sulfamerazyna<br />

sodowa, trimetoprim<br />

1682 Biotrisul Sulphadiazinum +<br />

Trimethoprimum<br />

1683 Biotrivit se Witamina a, b1, b2,<br />

b6, b12, c, d3, e, k3,<br />

wapnia pantotenian,<br />

nikotynamid, kwas<br />

foliowy, lizyna,<br />

metionina, tryptofan,<br />

selen<br />

1684 Biotropina Szczepionka<br />

wielowaz˙na dla koni,<br />

bydła, z´rebia˛t, ciela˛t,<br />

s´wiń i psów<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

1686 Biotum Ceftazidimum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1687 Biotum Ceftazidimum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1688 Biotum Ceftazidimum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1685 Biotum Ceftazidimum Powder for solution<br />

for intravenous<br />

injection and for<br />

infusion<br />

1689 Biotyl 200 Tylozyna zasada Solution for veterinary<br />

use<br />

1690 Biotyl 50 Tylozyna zasada, Solution for veterinary<br />

use<br />

Biowet Drwalew 31/12/08<br />

Biowet Drwalew 31/12/08<br />

Biowet Drwalew 31/12/08<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

31/12/08<br />

1 g Bioton Sp. z o.o. 30/10/05<br />

250 mg Bioton Sp. z o.o. 30/09/05<br />

500 mg Bioton Sp. z o.o. 7/06/05<br />

2 g Bioton Sp. z o.o. 30/10/05<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

1691 Biotymolol Timololum Sublingual tablets 0,25 mg Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z.o.o Lublin<br />

1692 BIO-VAC B1 Z˙ywa szczepionka dla<br />

kur przeciwko<br />

rzekomemu pomorowi<br />

drobiu<br />

1693 BIO-VAC ND-IB Szczepionka dla kur<br />

przeciw rzekomemu<br />

pomorowi drobiu oraz<br />

zakaz´nemu zapaleniu<br />

oskrzeli<br />

1694 Bioval Parachlorometakrezol,<br />

Chloroksylenol, Mydło<br />

potasowe<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

1695 Biovetalgin Metamizolum Solution for veterinary<br />

use<br />

18/08/04<br />

18/08/04<br />

31/12/08<br />

Fatro S.p.A. 21/02/06<br />

FATRO 21/02/05<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

3/09/04<br />

10/02/04<br />

1696 Biovision Capsuels, hard P.T. Indofarma 5/07/06<br />

1697 Biovital Coated tablets Roche Consumer Health Ltd 31/05/04<br />

1698 Biovital Oral solution Roche Consumer Health Ltd 31/05/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 835<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1699 Biovital Dragee 33 Coated tablets Roche Consumer Health Ltd 31/05/04<br />

1700 Biovital Gel (Kinder-Biovital<br />

Gel)<br />

Oral gel Roche Consumer Health Ltd 31/05/04<br />

1701 Biovital Lecytyna Oral solution Roche Consumer Health Ltd 31/05/04<br />

1702 Biovital N Coated tablets Roche Consumer Health Ltd 31/05/04<br />

1703 Biovital N Oral solution Roche Consumer Health Ltd 31/05/04<br />

1704 Biovital Plus Buccal tablet Roche Consumer Health Ltd 31/05/04<br />

1705 Biovital Spezial mit Lecithin Oral solution Roche Consumer Health Ltd 31/05/04<br />

1706 Biovitamine Tablets Laboratoires BOIRON 31/12/07<br />

1707 Biowar Amitrazum Bee- hive strip for veterinary<br />

use<br />

1708 Bioxazon Dexamtehasone<br />

isonicotinate<br />

Suspension for veterinary<br />

use<br />

Biowet Puławy 31/12/08<br />

Biowet Drwalew 31/12/08<br />

1709 Bioxetin Fluoxetinum Tablets 20 mg Sanofi-Synthelabo Sp. z o.o. 13/10/05<br />

1710 Bioxylin Acidum clavulanicum<br />

+ Amoxicillinum<br />

1711 Bipestos Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli i rzekomemu<br />

pomorowi drobiu dla<br />

kur<br />

1712 Bipressin Reserpinum +<br />

Todralazini<br />

hydrochloridum<br />

1713 Bi-Profenid Ketoprofenum Modified release<br />

tablets<br />

Powder for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Biowet Drwalew 31/12/08<br />

Merial 30/06/04<br />

Tablets 0,2mg + 20mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05<br />

150 mg Rhône-Poulenc Rorer Specia 31/05/04<br />

1714 Bisac Bisacodylum Suppository 10 mg US Pharmacia 31/12/08<br />

1715 Bisac Bisacodylum Tablets 5 mg US Pharmacia 31/12/08<br />

1717 Bisacodyl Bisacodylum Gastro-resistant<br />

tablets<br />

5 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

1716 Bisacodyl Bisacodylum Suppository 10 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

1718 Biseko Solution for<br />

intravenous infusion<br />

1719 Biseptol Sulfamethoxazolum +<br />

Trimethoprimum<br />

1720 Biseptol 120 Sulfamethoxazolum +<br />

Trimethoprimum<br />

1721 Biseptol 480 Sulfamethoxazolum +<br />

Trimethoprimum<br />

1722 Biseptol 480 Sulfamethoxazolum +<br />

Trimethoprimum<br />

1723 Biseptol 960 Sulfamethoxazolum +<br />

Trimethoprimum<br />

1724 Biseptyl Lincomycinum +<br />

Spektinomycinum<br />

31/01/06<br />

50 mg/ml Biotest Pharma GmbH 31/03/04<br />

Oral suspension 240 mg/5ml Medana Pharma Terpol<br />

Group S.A.<br />

Tablets 100mg +<br />

20mg<br />

Solution for<br />

intravenous infusion<br />

Tablets 400mg +<br />

80mg<br />

Tablets 800mg +<br />

160mg<br />

Solution for veterinary<br />

use<br />

Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

480 mg/5ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

30/10/05<br />

30/10/05<br />

30/11/05<br />

30/10/05<br />

30/10/05<br />

Laboratorios Syva 31/12/08


EN<br />

836 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1725 BISMUTHUM Pentarkan /Ptk<br />

nr 16/<br />

DHU-Arzneimittel GmbH &<br />

Co.KG<br />

5/02/05<br />

1726 Bisocard Bisoproli fumaras Film-coated tablets 2,5 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

1727 Bisocard Bisoprololum Film-coated tablets 10 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

1728 Bisocard Bisoprololum Film-coated tablets 5 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

1729 Bisocor 10 Bisoprololum Film-coated tablets 10 mg HEXAL AG 26/09/07<br />

1730 Bisocor 5 Bisoprololum Film-coated tablets 5 mg HEXAL AG 26/09/07<br />

1731 Bisodol Magaldratum + Acidum<br />

alginicum + Natrii<br />

carbonas<br />

Chewable tablets 400 mg +<br />

200 mg +<br />

100 mg<br />

Whitehall Laboratories Ltd. 31/12/08<br />

1732 Bisogamma 10 Bisoprololum Film-coated tablets 10 mg Wörwag Pharma GmbH Co.<br />

KG<br />

1733 Bisogamma 5 Bisoprololum Film-coated tablets 5 mg Wörwag Pharma GmbH Co.<br />

KG<br />

1734 Bisolvan Bromhexinum Syrup 4 mg/5 ml Boehringer Ingelheim<br />

International GmbH<br />

1735 Bisolvon Bromhexinum Oral solution and for<br />

inhalation<br />

2 mg/ml Boehringer Ingelheim<br />

International GmbH<br />

1736 Bisolvon Bromhexinum Solution for injection 2 mg/ml Boehringer Ingelheim<br />

International GmbH<br />

1737 Bisolvon Bromhexinum Tablets 8 mg Boehringer Ingelheim<br />

International GmbH<br />

1738 Bisoprolol Bisoprololum Tablets 5mg; 10 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

1739 BISOPROLOL 10 mg Bisoprololum Film-coated tablets 10 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

1740 BISOPROLOL 5 mg Bisoprololum Film-coated tablets 5 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

1741 Bisoprolol Fumarate Bisoprololum Film-coated tablets 10 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

1742 Bisoprolol Fumarate Bisoprololum Film-coated tablets 5 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/05/04<br />

31/05/04<br />

31/03/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

1743 Bisopromerck 10 Bisoprololum Film-coated tablets 10 mg Merck dura Gmbh 31/05/05<br />

1744 Bisopromerck 5 Bisoprololum Film-coated tablets 5 mg Merck dura Gmbh 31/05/05<br />

1745 Bisoratio 10 Bisoprololum Tablets 10 mg ratiopharm GmbH 31/12/08<br />

1746 Bisoratio 5 Bisoprololum Tablets 5 mg ratiopharm GmbH 31/12/08<br />

1747 BITTER ELIXIR Syrup WALA-Heilmittel GmbH 24/05/07<br />

1748 BI-VAC 1o Szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu oskrzeli<br />

(szczepienie pierwsze)<br />

1749 BI-VAC 2o Szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu oskrzeli<br />

(szczepienie drugie)<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Fatro S.p.A. 8/09/05<br />

Fatro S.p.A. 8/09/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 837<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1752 Bivacyn Bacitracinum +<br />

Neomycinum<br />

1750 Bivacyn Bacitracinum +<br />

Neomycinum<br />

1753 Bivacyn Bacitracinum +<br />

Neomycinum<br />

1751 Bivacyn Bacitracinum +<br />

Neomycinum<br />

1754 Bivacyn Bacitracinum +<br />

Neomycinum<br />

Cutaneous powder<br />

spray<br />

Lek Pharmaceuticals d.d. 30/04/04<br />

Eye ointment Lek Pharmaceuticals d.d. 31/07/04<br />

Medicated powder Lek Pharmaceuticals d.d. 30/04/04<br />

Powder and solvent<br />

for eye drops<br />

Powder for veterinary<br />

use<br />

Lek Pharmaceuticals d.d. 31/07/04<br />

Lek Pharmaceutical and<br />

Chemical Company<br />

10/02/04<br />

1755 Bizmutawy azotan zasadowy A.C.E.F., Włochy 31/12/08<br />

1756 Bizmutawy azotan zasadowy BUFA b.v. Pharmaceutical<br />

Products<br />

1757 Bizmutawy azotan zasadowy Margo Corporation,<br />

Warszawa<br />

31/12/08<br />

31/12/08<br />

1758 Bizmutawy azotan zasadowy Pharma Cosmetic, Kraków 31/12/08<br />

1759 Bizmutawy azotan zasadowy Pharma Zentrale 31/12/08<br />

1760 Bizmutawy azotan zasadowy<br />

(Bismuthi subnitras)<br />

PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

1761 Bizmutawy galusan zasadowy Aflofarm Fabryka Leków,<br />

Ksawerów<br />

4/03/07<br />

31/12/05<br />

1762 Bizmutawy galusan zasadowy Cefarm Szczecin 31/12/05<br />

1763 Bizmutawy galusan zasadowy Farm-Impex s.j., Gliwice 31/12/05<br />

1764 Bizmutawy galusan zasadowy Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

31/12/05<br />

1765 Bizmutawy galusan zasadowy Lefarm, Bydgoszcz 31/12/05<br />

1766 Bizmutawy galusan zasadowy Pharma Cosmetic, Kraków 31/12/05<br />

1767 Bizmutawy galusan zasadowy Pharma Zentrale 31/12/05<br />

1768 Bizmutawy galusan zasadowy PPF GEMI, Karczew 31/12/05<br />

1769 Bizmutawy we˛glan zasadowy BUFA b.v. Pharmaceutical<br />

Products<br />

24/01/05<br />

1770 Bizmutawy we˛glan zasadowy Galenus, Warszawa 24/01/05<br />

1771 Bizmutawy we˛glan zasadowy Pharma Cosmetic, Kraków 24/01/05<br />

1772 Bizmutawy we˛glan zasadowy Pharma Zentrale 24/01/05<br />

1774 Blastolem Cisplatinum Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

infusion<br />

1773 Blastolem Cisplatinum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

10 mg Lemery SA de C.V. 31/12/04<br />

50 mg Lemery SA de C.V. 31/12/04<br />

1775 Blend-A-Med Junior Cherry Dental gel Blendax 31/12/05<br />

1776 Bleocin Bleomycinum Lyophilisate for<br />

solution for injection<br />

15 mg Nippon Kayaku Co. Ltd. 30/04/05


EN<br />

838 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1777 Blocalcin 60 Diltiazemum Tablets 60 mg PLIVA — LACHEMA a.s. 31/05/04<br />

1778 Blocalcin 90 Retard Diltiazemum Prolonged release<br />

tablets<br />

90 mg PLIVA — LACHEMA a.s. 31/05/04<br />

1779 Blok Famotidinum Film-coated tablets 10 mg US Pharmacia 31/12/08<br />

1780 Blopress Candesartanum Tablets 16 mg Takeda Chemical Industries<br />

Ltd.<br />

1781 Blopress Candesartanum Tablets 4 mg Takeda Chemical Industries<br />

Ltd.<br />

1782 Blopress Candesartanum Tablets 8 mg Takeda Chemical Industries<br />

Ltd.<br />

1783 Blopress Comp Forte Candensartanum<br />

cilexetilum + Hydrochlorothiazidum<br />

1784 Blu-Gard Kwas dodecylobenzenosulfonowy<br />

1785 Błe˛kit metylenowy Methylenum<br />

coeruleum<br />

1786 Błe˛kit metylenowy Methylenum<br />

coeruleum<br />

Tablets 16 mg +<br />

12,5 mg<br />

Liquid for veterinary<br />

use<br />

31/12/04<br />

31/12/04<br />

31/12/04<br />

Takeda 31/12/08<br />

Henkel-Ecolab 31/12/08<br />

Pharma Zentrale 9/01/05<br />

PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

9/01/05<br />

1787 Błe˛kit metylenowy Pharma Cosmetic, Kraków 9/01/05<br />

1788 Bobo-Balneosan Instant herba tea for<br />

external use<br />

1789 Bobodent Chamomillae extractum<br />

siccum + Thymi<br />

extractum siccum +<br />

Lidocainum<br />

1790 Bobodent AD Lidocainum +<br />

Chamomillae anthodium<br />

extr. sic. + Thymi herba<br />

extr. sic.<br />

Gel (0,5g + 0,5g +<br />

0,5g)/100g<br />

Herbapol Lublin S.A. 31/08/05<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Oromucosal gel Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/05<br />

31/12/08<br />

1791 Bobofen fix Instant herbal tea Herbapol Lublin S.A. 31/08/05<br />

1792 Bobolan Olejek sosonowy, Olejek<br />

eukaliptusowy, Olejek<br />

rozmarynowy<br />

1793 Bobolan Ointment preparat<br />

złoz˙ony<br />

1794 Bobolux -Mieszanka ziołowa<br />

dla niemowla˛t i dzieci<br />

Ointment Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Herbal tea Herba Lux s.c. Zakład<br />

Przetwórstwa Zielarskiego<br />

1795 Bobonisan Herbal tea Bonimed Laboratorium<br />

Medycyny Naturalnej<br />

1796 Bobonisan Herbal tea Laboratorium Medycyny<br />

Naturalnej ‘BONIMED’,<br />

Z˙ywiec<br />

1797 Boboterm Cream Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

1798 Bobotic Simeticonum Oral drops 66.66 mg/ml Medana Pharma Terpol<br />

Group S.A.<br />

1799 Bocheńska lecznicza sól<br />

jodowo- bromowa<br />

Crystilline powder Zakład Przeróbki Solanek<br />

Jodowo-Bromkowych ‘Solco’<br />

s.c.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

28/09/05<br />

31/12/08<br />

16/05/07<br />

31/05/06<br />

31/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 839<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1800 Bodikal Szczepionka przeciw<br />

ospie kur<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Pliva 20/04/05<br />

1801 Bodymax Preparat złoz˙ony Film-coated tablets Dansk Droge A/S 30/11/04<br />

1803 Bodymax Z˙eń-szeń Ginseng radix extracum<br />

siccum<br />

1802 Bodymax Z˙eń-szeń Ginseng radix extracum<br />

siccum<br />

Film-coated tablets 200 mg Dansk Droge A/S 27/06/07<br />

Oral solution 13 mg/ml Dansk Droge A/S 27/06/07<br />

1804 Boldaloin Tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

1805 Boldovera Aloes extractum siccum<br />

+ Boldinum + Fumaria<br />

officinalis herba<br />

1806 Bolfo — obroz˙a dla kotów i<br />

małych psów<br />

Tablets 15mg + 1mg +<br />

10mg<br />

propoksur Collar for veterinary<br />

use<br />

1807 Bolfo — obroz˙a dla psów propoksur Collar for veterinary<br />

use<br />

1808 Bolfo — puder Propoksur Powder for veterinary<br />

use<br />

1809 Bolfo-Spray Propoksur Spray for veterinary<br />

use<br />

1810 Bolfo-szampon Propoksur Shampoo for veterinary<br />

use<br />

AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

31/08/05<br />

31/05/05<br />

Bayer AG 28/06/04<br />

Bayer AG 28/06/04<br />

Bayer AG 28/06/04<br />

Bayer AG 28/06/04<br />

Bayer AG 28/06/04<br />

1811 Bolinet Ibuprofenum Effervescent tablets 200 mg UPSA Laboratoires Agen 27/06/07<br />

1812 Bolinet Ibuprofenum Film-coated tablets 200 mg UPSA Laboratoires Agen 27/06/07<br />

1813 Boloxen Naproxenum Film-coated tablets 220 mg Kato LABS Sp. z o.o. 11/10/06<br />

1814 BOLUS ALBA comp. Powder for<br />

suspension<br />

1815 Bondronat Acidum ibandronicum Concantrate for<br />

solution for<br />

intravenous infusion<br />

WALA-Heilmittel GmbH 24/05/07<br />

1 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

15/11/06<br />

1816 Bonefos Acidum clodronicum Capsules 400 mg Schering AG 30/04/04<br />

1817 Bonefos Acidum clodronicum Concentrate for<br />

solution for<br />

intravenous infusion<br />

60 mg/ml Schering AG 30/04/04<br />

1818 Bonefos Acidum clodronicum Film-coated tablets 400 mg Schering AG 14/12/05<br />

1819 Bonefos Acidum clodronicum Film-coated tablets 800 mg Schering AG 14/12/05<br />

1820 Bonifen Ibuprofenum Film-coated tablets 200 mg KRKA d.d., Novo mesto 31/12/08<br />

1821 Bonine Meclozinum Buccal tablets 25 mg Pfizer S.A. 31/12/08<br />

1822 Boracelle 250 Boraginis officinalis<br />

oleum<br />

1823 Boracelle 500 Boraginis officinalis<br />

oleum<br />

Capsules 250 mg Bio Oil International Ltd. 5/07/06<br />

Capsules 500 mg Bio Oil International Ltd. 5/07/06<br />

1824 Borage oil Boraginis semen oleum Capsule, soft 1000 mg PRO NATURA s.j. 31/12/08<br />

1825 Borage Oil Boraginis officinalis<br />

oleum + Tocopherolum<br />

Capsules Power Health Products Ltd. 29/02/04


EN<br />

840 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1826 BORAGO comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

1827 BORAGO comp. gran. WALA-Heilmittel GmbH 19/03/05<br />

1828 Boragoglandyna 100 Capsules 500 mg Betuland Sp. z o.o. 30/10/05<br />

1829 Borasol Acidum boricum Liquid 300 mg/g Prolab s.c. — Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Produkcyjno-Analityczno-<br />

Handlowe s.c. Paterek<br />

1830 Borgal 24 % Sulfadoksyna ,<br />

Trimetoprim<br />

Solution for veterinary<br />

use<br />

8/02/06<br />

Intervet 11/03/04<br />

1831 Borowinowa kostka iwonicka Compress Uzdrowisko Iwonicz —<br />

Spółka Akcyjna<br />

1832 Botox Toksyna botulinowa<br />

typu A<br />

1833 Bovaclox DC Sól sodowa<br />

kloksacyliny,<br />

Trójwodzian<br />

ampicyliny<br />

1834 Bovamast DC neomycyny siarczan,<br />

benzylopenicylina<br />

prokainowa,<br />

penetamatu<br />

jodowodorek<br />

1835 Boviglobin Gamma-globulina<br />

bydle˛ca 10 %<br />

1836 Boviketozin Siarczan kobaltu,<br />

jodek potasu<br />

1837 Bovitrichovac II Szczepionka przeciw<br />

grzybicy skórnej bydła<br />

1838 Bovituberculin (Bovituberculin<br />

AN5)<br />

1839 Bóle menstruacyjne<br />

HomeoPorady<br />

Białko tuberkulinowe z<br />

przesa˛czu hodowli<br />

Mycobacterium bovis<br />

AN5<br />

Powder for solution<br />

for intramuscular<br />

injection<br />

Intramammary<br />

suspension<br />

Intramammary<br />

suspension<br />

100 j.m. Allergan Pharmaceuticals<br />

(Ireland) Limited<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

31/01/06<br />

9/07/06<br />

Norbrook Laboratories Ltd. 14/07/07<br />

Bimeda 31/12/08<br />

Drwalewskie Zakłady Przem.<br />

Bioweterynaryjnego<br />

31/12/08<br />

Biowet Puławy 31/12/08<br />

Biowet Puławy 31/12/08<br />

Biowet Puławy 31/12/08<br />

Laboratoires BOIRON 30/06/07<br />

1840 Braunovidon Povidone-iodine Ointment 100 mg/g B. Braun Melsungen AG 12/04/06<br />

1841 Bretylate Bretylii tosilas Solution for injection 50 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

1842 Brevibloc Esmololum Concentrate for<br />

solution for<br />

intravenous infusion<br />

1843 Brevibloc Esmololum Solution for<br />

intravenous infusion<br />

30/06/04<br />

250 mg/ml Torrex Pharma GmbH 31/12/08<br />

10 mg/ml Torrex Pharma GmbH 31/12/08<br />

1844 Brevoxyl Benzoili peroxydum Gel 4 % Stiefel Laboratoires 6/12/06<br />

1845 Brevoxyl Benzoylis peroxydum Gel 40 mg/g Stiefel Laboratories (UK) Ltd. 6/12/06<br />

1846 Brietal Methohexitalum Powder for solution<br />

for injection<br />

1847 Brinerdin Clopamidum +<br />

Dihydroergocristinum +<br />

Reserpinum<br />

0.5 g Lilly Pharma Fertigung und<br />

Distribution GmbH & Co. KG<br />

31/07/04<br />

Coated tablets Krka d.d., Novo mesto 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 841<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1848 Brocalcin Calcii bromolactobionas Granules 400 mg/g VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

1849 Brocalcin Calcii bromolactobionas Syrup 150 mg/g VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

31/12/06<br />

31/12/06<br />

1850 Brocosin syrop Heel, Hiszpania 4/07/06<br />

1851 Brodacid Acidum lacticum +<br />

Acidum salicylicum +<br />

Dimethylis sulfoxydum<br />

Coutanous liquid Inco-Veritas S.A. Oddział w<br />

Pruszkowie; Celia Zakład<br />

Produkcji Kosmetyczno-<br />

Farmaceutycznej<br />

31/01/05<br />

1852 Bromek amonowy Hasco-Lek, Wrocław 11/12/06<br />

1853 Bromek amonowy Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

11/12/06<br />

1854 Bromek potasu Hasco-Lek, Wrocław 31/08/06<br />

1855 Bromek potasu Pampa, Piaseczno 31/08/06<br />

1856 Bromek sodu Pampa, Piaseczno 20/03/06<br />

1857 Bromek sodu Pharma Cosmetic, Kraków 20/03/06<br />

1858 Bromek sodu PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

20/03/06<br />

1859 Bromergon Bromocriptinum Tablets 2.5 mg Lek Pharmaceuticals d.d. 30/06/04<br />

1860 Bromergon Bromocriptinum Tablets 2.5 mg Lek Polska Sp. z o.o. 31/12/05<br />

1861 Bromhexin Bromhexinum Film-coated tablets 8 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

1862 Bromhexin 8 Bromhexinum Syrup 8 mg/10 ml Krewel Meuselbach GmbH<br />

Eitorf<br />

1863 Bromocorn Bromocriptinum Tablets 2.5 mg Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

7/05/06<br />

16/05/07<br />

31/01/06<br />

1864 Bronchalis-Heel Tablets Heel GmbH 31/12/07<br />

1865 BRONCHI/PLANTAGO comp.,<br />

ampułki<br />

1866 BRONCHI/PLANTAGO comp.,<br />

granulki<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

1867 Bronchial fix Instant herbal tea Herbapol Lublin S.A. 30/10/05<br />

1868 Bronchialtee 400 TAD Pharmaceutice 31/12/08<br />

1872 Bronchicum Preparat złoz˙ony Buccal tablet A. Natterman & Cie.GmbH<br />

Rhone-Poulenc Rorer<br />

29/02/04<br />

1869 Bronchicum Preparat złoz˙ony Capsules Rhône-Poulenc Rorer GmbH 31/12/08<br />

1870 Bronchicum Preparat złoz˙ony Oral drops, solution A. Natterman & Cie.GmbH<br />

Rhone-Poulenc Rorer<br />

1871 Bronchicum Preparat złoz˙ony Syrup A. Natterman & Cie.GmbH<br />

Rhone-Poulenc Rorer<br />

30/05/05<br />

29/02/04<br />

1873 Bronchicum Elixir Preparat złoz˙ony Oral solution Rhône-Poulenc Rorer GmbH 30/05/05<br />

1874 Bronchicum K Preparat złoz˙ony Drops Rhône-Poulenc Rorer GmbH 31/12/08<br />

1875 Bronchicum N Thymi extractum fluidum Syrup Rhône-Poulenc Rorer GmbH 31/12/08


EN<br />

842 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1876 Bronchicum T Thymi extractum fluidum Buccal tablet 0.1 g Rhône-Poulenc Rorer GmbH 31/12/08<br />

1877 Bronchitis Vaccine Chick Uni<br />

Hol<br />

szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu oskrzeli<br />

Lyophilisate for veterinary<br />

use<br />

Lohmann Animal Health<br />

International<br />

31/12/08<br />

1878 Bronchomil Syrup Masters Sp. z o.o. 31/01/05<br />

1879 Bronchonorm Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

1880 Bronchonorm Syrup Herbapol — Lublin S.A. 31/12/08<br />

1881 Bronchopect Hederae helicis folium<br />

extractum<br />

Oral drops, solution 935 mg/ml Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

1885 Bronchopront Ambroxolum Effervescent tablets 30 mg Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

1883 Bronchopront Ambroxolum Oral drops, solution 7.5 mg/ml Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

1882 Bronchopront Ambroxolum Prolonged release<br />

capsules<br />

75 mg Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

1884 Bronchopront Ambroxolum Syrup 15 mg/5 ml Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

1886 Bronchosol Primulae tinctura +<br />

Thymi extractum fluidum<br />

1887 Bronchosol Thymi herbae et<br />

Primulae radix extractum<br />

spissum + Thymolum<br />

31/03/07<br />

31/05/05<br />

30/06/04<br />

31/12/04<br />

30/06/04<br />

Liquid Phytopharm Kle˛ka S.A. 31/12/08<br />

Syrup Phytopharm Kle˛ka S.A. 17/01/07<br />

1888 Broncho-Vaxom Capsules 3.5 mg OM Pharma (dawniej<br />

Laboratories OM)<br />

1889 Broncho-Vaxom Capsules 7 mg OM Pharma (dawniej<br />

Laboratories OM)<br />

1890 Bronchovit Instant herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

1891 Bronhelix (poprzednia nazwa:<br />

efelix), kapsułki<br />

Hederae helicis folium<br />

pulv.<br />

1892 Bronhikal I Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli u kurcza˛t<br />

1893 Bronhikal II Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli dla kur<br />

1894 Bronhopest Z˙ywa szczepionka<br />

przeciw rzekomemu<br />

pomorowi drobiu i<br />

zakaz´nemu zapaleniu<br />

oskrzeli kur dla<br />

kurcza˛t<br />

1895 Bronhopest B1 Z˙ywa szczepionka<br />

przeciw rzekomemu<br />

pomorowi drobiu i<br />

zakaz´nemu zapaleniu<br />

oskrzeli kur dla<br />

kurcza˛t<br />

30/04/04<br />

30/04/04<br />

15/03/06<br />

Capsules 150 mg Phytopharm Kle˛ka S.A. 31/12/08<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Pliva 11/02/04<br />

Pliva 20/04/05<br />

Pliva 20/04/05<br />

Pliva 20/04/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 843<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1896 Bronipra ND/IBD szczepionka dla drobiu<br />

przeciwko zakaz´nemu<br />

zapaleniu oskrzeli,<br />

rzekomemu pomorowi<br />

drobiu oraz zapaleniu<br />

torby fabrycjusza<br />

1897 Bronipra-1 Z˙ywa szczepionka dla<br />

kur przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Hipra 31/12/08<br />

Laboratorios Hipra S.A. 24/06/07<br />

1898 Brostagin Pyridostigminum Syrup 60 mg/5 ml Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

1899 Brostagin Pyridostigminum Tablets 60 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

1900 Brulamycin Tobramycinum Eye drops 3 mg/ml Biogal Pharmaceutical Works<br />

Ltd.<br />

1901 Brulamycin Tobramycinum Solution for<br />

intramuscular and<br />

intravenous injection<br />

40 mg/1 ml Biogal Pharmaceutical Works<br />

Ltd.<br />

31/12/08<br />

31/12/08<br />

30/01/05<br />

30/11/04<br />

1902 Bryaconeel Tablets Heel GmbH 31/12/07<br />

1903 BRYONIA/STANNUM Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

1904 BRYONIA/STANNUM Granules WALA-Heilmittel GmbH 24/05/07<br />

1905 BSC 6 Sulfachloropyrazyna<br />

sodowa<br />

Powder for veterinary<br />

use<br />

Bremer Pharma 31/12/08<br />

1906 BSS Solution for irrigation Alcon Couvreur N.V. 31/07/04<br />

1907 BSS Plus Solution for irrigation Alcon Couvreur N.V. 30/09/04<br />

1908 B-tabs Multivitamins Film-coated tablets Ferrosan A/S 21/03/07<br />

1909 Budenofalk Budesonidum Gastro-resistant<br />

capsules<br />

1910 Buderhin, Budesonid Budesonidum Nasal spray,<br />

suspension<br />

3 mg Dr Falk Pharma GmbH 16/05/07<br />

50 mcg/dawke˛<br />

donosowa˛<br />

1911 Budesonid Airmax Budesonidum Inhalation powder 100 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

1912 Budesonid Airmax Budesonidum Inhalation powder 200 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

1913 Budesonid Airmax Budesonidum Inhalation powder 400 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

1914 Budesonid forte Budesonidum Pressurised inhalation,<br />

suspension<br />

1915 Budesonid mite Budesonidum Pressurised inhalation,<br />

suspension<br />

1916 Buer Kinder<br />

Vitamine+Eisen+Calcium<br />

200 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

50 mcg/dawke˛<br />

inhalacyjna˛<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/01/05<br />

Norton Healthcare Ltd. 31/12/08<br />

Norton Healthcare Ltd. 31/12/08<br />

Norton Healthcare Ltd. 31/12/08<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Syrup Altana Consumer Health<br />

GmbH<br />

1917 Buerlecithin Oral solution Altana Consumer Health<br />

GmbH<br />

31/12/05<br />

31/12/05<br />

31/05/04<br />

30/06/04


EN<br />

844 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1918 Buflox 150 Buflomedilum Film-coated tablets 150 mg Hexal AG 12/06/06<br />

1919 Buflox 300 Buflomedilum Film-coated tablets 300 mg Hexal AG 12/06/06<br />

1920 Buflox Retard Buflomedilum Prolonged release<br />

tablets<br />

600 mg Hexal AG 12/06/06<br />

1921 Bultabs Preparat złoz˙ony Tablets Perrigo Co 31/12/08<br />

1922 Bunondol Buprenorphinum Solution for<br />

intramuscular and<br />

intravenous injection<br />

0.3 mg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

1923 Bunondol Buprenorphinum Sublingual tablets 0.2 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

1924 Bunondol Buprenorphinum Sublingual tablets 0.4 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

1925 Bupivacainum hydrochloricum<br />

0,25 %<br />

1926 Bupivacainum hydrochloricum<br />

0,25 %<br />

1927 Bupivacainum hydrochloricum<br />

0,5 %<br />

1928 Bur-Cell S — 706+HVT Szczepionka dla kur<br />

przeciw chorobie<br />

Mareka i chorobie<br />

Gumboro<br />

1929 Bursaplex Szczepionka dla kur<br />

przeciw chorobie<br />

Gumboro<br />

Bupivacainum Injection 0.25 % Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Bupivacainum Injection 0.25 % Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Bupivacainum Solution for injection 5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Suspension + solvent for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

31/05/05<br />

31/05/05<br />

31/05/05<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

Merial Select Inc. 6/06/05<br />

Merial Select Inc. 31/12/08<br />

1930 Buscolysin Butylscopolaminum Solution for injection 20 mg/1 ml Pharmachim-Holding AD 31/07/04<br />

1934 Buscopan Butylscopolaminum Film-coated tablets 10 mg Boehringer Ingelheim<br />

International GmbH<br />

1933 Buscopan Butylscopolaminum Solution for injection 20 mg/1 ml Boehringer Ingelheim<br />

International GmbH<br />

1931 Buscopan Butylscopolaminum Suppository 10 mg Boehringer Ingelheim<br />

International GmbH<br />

1932 Buscopan Butylscopolaminum Suppository 7.5 mg Boehringer Ingelheim<br />

International GmbH<br />

1935 Buscopan compositum VET Butyloskopolaminy<br />

bromowodorek,<br />

Metamizolu sól<br />

sodowa<br />

1936 Buscopan Plus Hyoscini — N —<br />

butylbramidum<br />

Solution for veterinary<br />

use<br />

Boehringer<br />

IngelheimVetmedica GmbH<br />

Tablets 10 mg Boehringer Ingelheim<br />

International GmbH<br />

1937 Buspirone Buspironum Tablets 10 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

1938 Buspirone Buspironum Tablets 5 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

1939 Butapirazol Lidocainum +<br />

Phenylbutazonum<br />

Solution for injection Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

1941 Butapirazol Phenylbutazonum Coated tablets 200mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/07/05<br />

31/07/04<br />

31/12/07<br />

31/12/07<br />

15/02/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/11/05<br />

30/11/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 845<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1942 Butapirazol Phenylbutazonum Ointment 50 mg/g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

1940 Butapirazol Phenylbutazonum Suppository 250 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

1943 Butenafinum Hydrochloridum<br />

1%<br />

31/12/05<br />

31/12/05<br />

Butenafinum Cream UCB Pharma Sp. z o.o. 31/12/08<br />

1944 BUTINAX Forte Trimebutini maleas Tablets 200 mg Axcan Pharma Inc. 31/12/08<br />

1945 Butomidor Butorfanolu winian Solution for veterinary<br />

use<br />

1946 Butox 50 Deltametryna Liquid for veterinary<br />

use<br />

1947 Butox 7,5 Pour On Deltametryna Suspension for veterinary<br />

use<br />

Richter Pharma AG 19/12/06<br />

Intervet International B.V. 30/01/06<br />

Intervet International B.V. 30/01/06<br />

1948 Buvasodil Buflomedilum Film-coated tablets 150 mg ICN Polfa Rzeszów S.A. 12/06/06<br />

1949 Buvasodil Buflomedilum Film-coated tablets 300 mg ICN Polfa Rzeszów S.A. 12/06/06<br />

1950 Buventol Easyhaler Salbutamolum Inhalation powder 200 µg/dawke˛ ORION Corporation 31/12/08<br />

1951 Buventol Esasyhaler Salbutamolum Inhalation powder 100 µg/dawke˛ ORION Corporation 31/12/08<br />

1952 Buxal Buspironum Tablets 10 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1953 Buxal Buspironum Tablets 5 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

1954 Byol Bisoprololum Film-coated tablets 5 mg Lek Polska Sp. z o.o. 31/12/08<br />

1955 Byol Bisoprololum Film-coated tablets 10 mg Lek Polska Sp. z o.o. 31/12/08<br />

1956 Byol H Bisoprololum +<br />

Hydrochlorothiazidum<br />

1957 Byol H Bisoprololum +<br />

Hydrochlorothiazidum<br />

1958 Byol H Bisoprololum +<br />

Hydrochlorothiazidum<br />

Film-coated tablets 2,5 mg +<br />

6,25 mg<br />

Film-coated tablets 5 mg +<br />

12,5 mg<br />

Film-coated tablets 10 mg +<br />

25 mg<br />

Lek Polska Sp. z o.o. 31/12/08<br />

Lek Polska Sp. z o.o. 31/12/08<br />

Lek Polska Sp. z o.o. 31/12/08<br />

1959 Cabaser Cabergolinum Tablets 1 mg Pharmacia & Upjohn SpA 31/12/08<br />

1960 Cabaser Cabergolinum Tablets 2 mg Pharmacia & Upjohn SpA 31/12/08<br />

1961 Cabaser Cabergolinum Tablets 4 mg Pharmacia & Upjohn SpA 31/12/08<br />

1962 Cactus comp. Amp. Heel GmbH 9/07/07<br />

1963 CACTUS comp. I amp. WALA-Heilmittel GmbH 19/03/05<br />

1964 CACTUS comp. I gran. WALA-Heilmittel GmbH 19/03/05<br />

1965 CACTUS comp. II amp. WALA-Heilmittel GmbH 19/03/05<br />

1966 CACTUS comp. II gran. WALA-Heilmittel GmbH 19/03/05<br />

1967 Cactus compositum S Drops Heel GmbH 31/12/07<br />

1968 Caelyx Doxorubicinum Concentrate for<br />

infusion<br />

2mg/ml Schering — Plough Central<br />

East S.A.<br />

31/12/08


EN<br />

846 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1969 Cai Pan Mint Menthae piperitae Ointment for veterinary<br />

use<br />

1970 Cal — D — Vita Calcii carbonas +<br />

Colecalciferolum<br />

1971 Cal — D — Vita Calcii carbonas +<br />

Colecalciferolum<br />

Buccal tablets 400 j.m. D3 +<br />

600 mg Ca2+<br />

Effervescent tablets 400 j.m. D3 +<br />

600 mg Ca2+<br />

CAI PAN A/S 31/12/08<br />

Roche Consumer Health<br />

(Worldvide) S.A.<br />

Roche Consumer Health<br />

(Worldvide) S.A.<br />

1972 Caladix Ointment Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

1973 Calben Calcii<br />

gluconolactobionas,<br />

Calcii lactobionas<br />

1974 Calbend Calcii<br />

glukonolactobionas,<br />

Calcii lactobionas<br />

1975 Calcibone Powder for oral<br />

suspension<br />

1976 CALCICHEW O Smaku<br />

Cytrynowym<br />

1977 CALCICHEW/VITAMIN D3 O<br />

Smaku Pomarańczowym<br />

1978 CALCIFAR® O Smaku<br />

Cytrynowym<br />

1979 CALCIFAR® O Smaku<br />

Malinowym<br />

1980 CALCIFAR® O Smaku<br />

Pomarańczowym<br />

1981 CALCIFAR® O Smaku<br />

Truskawkowym<br />

1982 CALCIGEM O Smaku<br />

Agrestowym<br />

1983 CALCIGEM C O Smaku<br />

Pomarańczowym<br />

1984 CALCIGEM C O Smaku<br />

Agrestowym<br />

1985 CALCIGEM C O Smaku<br />

Cytrynowym<br />

1986 CALCIGEM O Smaku<br />

Cytrynowym<br />

1987 CALCIGEM O Smaku<br />

Pomarańczowym<br />

Syrup 114 mg Ca2+/<br />

5ml<br />

Syrup 114 mg Ca2+/<br />

5ml<br />

Farmaceutyczne<br />

Przedsie˛biorstwo Prod. —<br />

Anal. — Handl. ‘PROLAB’<br />

s.c., Nakło<br />

Farmaceutyczne<br />

Przedsie˛biorstwo Prod. —<br />

Anal. — Handl. ‘PROLAB’<br />

s.c., Nakło<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/09/07<br />

31/12/08<br />

Biomin a.s. 26/04/06<br />

Calcii carbonas Buccal tablets 500 mg Ca2+ Nycomed Pharma A/S 31/12/08<br />

Calcii carbonas,<br />

Colecalciferolum<br />

Buccal tablets 500 mg Ca2+,<br />

400 j.m. Wit.<br />

D3<br />

Nycomed Pharma A/S 31/12/08<br />

Calcii carbonas Buccal tablets 200 mg Ca2+ P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

Calcii carbonas Buccal tablets 200 mg Ca2+ P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

Calcii carbonas Buccal tablets 200 mg Ca2+ P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

Calcii carbonas Buccal tablets 200 mg Ca2+ P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

Calcium lactogluconas Effervescent powder 200 mg Ca2+ Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Calcii lactogluconas +<br />

Acidum ascorbicum<br />

Calcii lactogluconas +<br />

Acidum ascorbicum<br />

Calcii lactogluconas +<br />

Acidum ascorbicum<br />

1988 Calcigluc Glukonian wapnia,<br />

Glukonian magnezu,<br />

Chlorek wapnia,<br />

Chlorek magnezu<br />

Effervescent powder 200 mg Ca2+,<br />

200 mg<br />

Ascorbic acid<br />

Effervescent powder 200 mg Ca2+,<br />

200 mg<br />

Ascorbic acid<br />

Effervescent powder 200 mg Ca2+,<br />

200 mg<br />

Ascorbic acid<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Calcium lactogluconas Effervescent powder 200 mg Ca2+ Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Calcium lactogluconas Effervescent powder 200 mg Ca2+ Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Solution for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Biowet Puławy 24/05/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 847<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

1989 Calcihexal 50 Calcitoninum salmonis Solution for<br />

subcutaneous,<br />

intramuscular,<br />

intravenous injection<br />

1990 Calcihexal 100 Calcitoninum salmonis Solution for<br />

subcutaneous,<br />

intramuscular,<br />

intravenous injection<br />

1991 Calcii Borogluconas 25 Inj. Wapnia glukonian Solution for veterinary<br />

use<br />

50 j.m./ml Hexal AG 31/01/05<br />

100 j.m./ml Hexal AG 31/01/05<br />

Biowet Puławy 29/06/06<br />

1992 Calcijex Calcitriolum Solution for injection 1 mcg/ml Abbott Laboratories 9/08/05<br />

1993 Calcijex Calcitriolum Solution for injection 2 mcg/ml Abbott Laboratories 9/08/05<br />

1994 Calcimag powder for solution Chance — Zakład Produkcji<br />

Chemiczno —<br />

Farmaceutycznej s.c.<br />

1995 Calciphos Glukonian wapnia,<br />

Chlorek magnezu,<br />

Glicerynofosforan<br />

sodu<br />

1996 Calcipiryna Acidum acetylsalicylicum<br />

+ Calcii carbonas<br />

Liquid for veterinary<br />

use<br />

1997 Calcitonin Calcitoninum salmonis Solution for<br />

intramuscular,<br />

subcutaneous<br />

injection and for<br />

intravenous infusion<br />

1998 Calcitonin Calcitoninum salmonis Solution for<br />

intramuscular,<br />

subcutaneous<br />

injection and for<br />

intravenous infusion<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

50 j.m./1 ml Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

100 j.m./1 ml Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

1999 Calcitonin 50 Calcitoninum salmonis Liquid for injection 50 j.m./1 ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2001 Calcitonin 100 Calcitoninum salmonis Liquid for injection 100 j.m./1 ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2000 Calcitonin 100 Calcitoninum salmonis Nasal spray 100 j.m./dawke˛ Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

2002 Calcitonin 200 Calcitoninum salmonis Nasal spray 200 j.m./dawke˛ Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

2003 Calcitonin 200 Calcitoninum salmonis Nasal spray 200 j.m./dawke˛ Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

2004 Calcium Calcii glubionas + Calcii<br />

lactas<br />

2005 Calcium Calcii glubionas + Calcii<br />

lactas<br />

2006 Calcium Calcii glubionas + Calcii<br />

lactobionas<br />

Syrup 115 mg Ca++/<br />

5ml<br />

Syrup 116 mg Ca++/<br />

5ml<br />

Syrup 114 mg Ca++/<br />

5ml<br />

6/07/05<br />

10/06/04<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Polfarmex S.A 30/01/05<br />

Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

15/10/06<br />

ICN Polfa Rzeszów S.A. 31/12/05<br />

2008 Calcium Calcii lactas gluconas Effervescent powder 200 mg Ca++ AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

2009 Calcium Calcii lactas gluconas Effervescent powder 200 mg Ca++ AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

31/12/08<br />

31/12/08


EN<br />

848 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2010 Calcium Calcii lactas gluconas Effervescent powder 200 mg Ca++ AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

31/12/08<br />

2011 Calcium Calcii lactas gluconas Effervescent tablets 117 mg Ca++ Polfarmex S.A 30/09/07<br />

2012 Calcium Calcii lactas gluconas Effervescent tablets 210 mg Ca++ Farmaco Sp. z o.o 31/12/08<br />

2007 Calcium Calcii lactas gluconas Oral granules 52 mg Ca++/g ICN Polfa Rzeszów S.A. 31/12/05<br />

2013 Calcium Calcii lactogluconas Effervescent tablets 200 mg Ca++ Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

2014 CALCIUM — FARMACO Bez<br />

Dodatków Smakowych<br />

2015 CALCIUM — FARMACO O<br />

Smaku Cytrynowym<br />

2016 CALCIUM — FARMACO O<br />

Smaku Malinowym<br />

2017 CALCIUM — FARMACO O<br />

Smaku Pomarańczowym<br />

2018 Calcium (o smaku<br />

bananowym)<br />

31/01/06<br />

Calcii lactogluconas Effervescent tablets 210 Ca2+ Farmaco Sp. z o.o. 31/12/08<br />

Calcii lactogluconas Effervescent tablets 210 Ca2+ Farmaco Sp. z o.o. 31/12/08<br />

Calcii lactogluconas Effervescent tablets 210 mg Ca2+ Farmaco Sp. z o.o. 31/12/08<br />

Calcii lactogluconas Effervescent tablets 210 Ca2+ Farmaco Sp. z o.o. 31/12/08<br />

Calcii glubionas +<br />

Calcii lactas<br />

2019 Calcium (o smaku jez˙ynowym) Calcii glubionas +<br />

Calcii lactas<br />

2020 Calcium (o smaku<br />

truskawkowym)<br />

Calcii glubionas +<br />

Calcii lactas<br />

2021 Calcium (o smaku wis´niowym) Calcii glubionas +<br />

Calcii lactas<br />

Syrup 114 mg Ca++/<br />

5ml<br />

Syrup 114 mg Ca++/<br />

5ml<br />

Syrup 114 mg Ca++/<br />

5ml<br />

Syrup 114 mg Ca++/<br />

5ml<br />

Polfarmex S.A 31/01/05<br />

Polfarmex S.A 31/01/05<br />

Polfarmex S.A 31/01/05<br />

Polfarmex S.A 31/01/05<br />

2022 Calcium 100 Calcii carbonas Buccal tablet 100 mg Ca++ Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/01/05<br />

2023 Calcium 1000 Hexal Calcii carbonas Effervescent tablets 1000 mg Ca2+ HEXAL AG 31/12/08<br />

2024 Calcium 200 Calcii carbonas Effervescent granules 200 mg Ca++/<br />

5g<br />

2025 Calcium 200 Calcii lactogluconas Effervescent powder 200 mg Ca++/<br />

4g<br />

Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/05<br />

31/01/05<br />

2026 Calcium 300 Calcii carbonas Effervescent tablets 300 mg Ca++ Pharmavit Kft. 30/06/04<br />

2027 Calcium 300 Lemon Calcii carbonas Effervescent granules 300 mg Ca2+/<br />

saszetke˛<br />

2028 Calcium 300 Orange Calcii carbonas Effervescent granules 300 mg Ca2+/<br />

saszetke˛<br />

Przedsie˛biorstwo<br />

Farmaceutyczno —<br />

Chemiczne ‘Synteza’ Sp. z<br />

o.o.<br />

Przedsie˛biorstwo<br />

Farmaceutyczno —<br />

Chemiczne ‘Synteza’ Sp. z<br />

o.o.<br />

2029 Calcium 500 Calcii carbonas Buccal tablet 500 mg Ca++ Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

2030 Calcium 500 Calcii carbonas +<br />

Calcii lactogluconas<br />

Effervescent powder 500 mg Ca++ Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

31/01/05<br />

30/10/05<br />

2031 Calcium 500 Calcii lactas gluconas Effervescent powder 500 mg Ca++ Polfarmex S.A 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 849<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2032 Calcium 500 D Acidum ascorbicum<br />

(vit C) + Calcii lactas<br />

gluconas +<br />

Colecalciferolum<br />

Effervescent powder 60mg +<br />

500 mg Ca++<br />

+ 250 j.m.<br />

Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

31/12/08<br />

2033 Calcium 500 Hexal Calcii carbonas Effervescent tablets 500 mg Ca2+ HEXAL AG 31/12/08<br />

2034 Calcium 500 Lemon Calcii carbonas Effervescent granules 500 mg Ca2+/<br />

saszetke˛<br />

2035 Calcium 500 Orange Calcii carbonas Effervescent granules 500 mg Ca2+/<br />

saszetke˛<br />

2036 Calcium Borogluconatum 25 % Glukonian wapnia,<br />

Kwas borowy<br />

2037 CALCIUM C — Farmaco Calcii lactogluconas,<br />

Acidum ascorbicum<br />

2038 CALCIUM C — Farmaco Calcii lactogluconas,<br />

Acidum ascorbicum<br />

2039 CALCIUM C — Farmaco Calcii lactogluconas,<br />

Acidum ascorbicum<br />

2040 Calcium C effervescens Acidum ascorbicum<br />

(vit C) + Calcii lactas<br />

gluconas<br />

2041 Calcium C o smaku<br />

cytrynowym<br />

2042 Calcium C o smaku<br />

pomarańczowym<br />

2043 Calcium Carbonate ,<br />

Magnesium Oxide<br />

Colecalciferol<br />

2044 Calcium Carbonicum/Cortex<br />

Quercus<br />

2045 CALCIUM CARBONICUM/<br />

CORTEX QUERCUS amp.<br />

2046 CALCIUM CARBONICUM/<br />

CORTEX QUERCUS gran.<br />

Acidum ascorbicum<br />

(vit C) + Calcii<br />

lactogluconas<br />

Acidum ascorbicum<br />

(vit C) + Calcii<br />

lactogluconas<br />

Calcii carbonas +<br />

Magnesii oxidum +<br />

Colecalciferolum<br />

2047 Calcium C-farmaco Acidum ascorbicum<br />

(vit C) + Calcii lactas<br />

gluconas<br />

Solution for veterinary<br />

use<br />

Effervescent tablets 210 mg Ca2+,<br />

210 mg vit. C<br />

Effervescent tablets 210 mg Ca2+,<br />

210 mg vit. C<br />

Effervescent tablets 210 mg Ca2+,<br />

210 mg vit. C<br />

Przedsie˛biorstwo<br />

Farmaceutyczno —<br />

Chemiczne ‘Synteza’ Sp. z<br />

o.o.<br />

Przedsie˛biorstwo<br />

Farmaceutyczno —<br />

Chemiczne ‘Synteza’ Sp. z<br />

o.o.<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

31/12/08<br />

31/12/08<br />

28/04/04<br />

Farmaco Sp. z o.o. 31/12/08<br />

Farmaco Sp. z o.o. 31/12/08<br />

Farmaco Sp. z o.o. 31/12/08<br />

Effervescent powder Polfarmex S.A 31/12/05<br />

Effervescent tablets 200mg +<br />

200mg Ca++<br />

Effervescent tablets 200mg +<br />

200mg Ca++<br />

Film-coated tablets preparat<br />

złozony<br />

2048 Calcium chloratum 10 % Calcii chloridum Solution for<br />

intravenous injection<br />

2049 Calcium C-Polfarmex (o smaku<br />

jez˙ynowym)<br />

2050 Calcium C-Polfarmex (o smaku<br />

truskawkowym)<br />

2051 Calcium C-Polfarmex (o smaku<br />

brzoskwiniowym)<br />

Acidum ascorbicum<br />

(vit C) + Calcii lactas<br />

gluconas<br />

Acidum ascorbicum<br />

(vit C) + Calcii lactas<br />

gluconas<br />

Acidum ascorbicum<br />

(vit C) + Calcii lactas<br />

gluconas<br />

Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/01/05<br />

31/01/05<br />

31/12/08<br />

Amp. 10 ml WALA-Heilmittel GmbH 24/05/07<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

Effervescent tablets 210 mg Ca++ Farmaco Sp. z o.o 31/12/08<br />

100 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/01/05<br />

Effervescent tablets Polfarmex S.A 31/01/05<br />

Effervescent tablets Polfarmex S.A 31/01/05<br />

Effervescent tablets Polfarmex S.A 31/01/05


EN<br />

850 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2052 Calcium C-Polfarmex (o smaku<br />

pomarańczowym)<br />

Acidum ascorbicum<br />

(vit C) + Calcii lactas<br />

gluconas<br />

Effervescent tablets Polfarmex S.A 31/01/05<br />

2053 Calcium Dobesilate Calcii dobesilas Gelatin capsules, hard 500 mg Farmaceutyczna Spółdzielnia<br />

Pracy ‘GALENA’<br />

2054 Calcium dobesilate Calcii dobesilas Tablets 250 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

2055 Calcium dobesilate Calcii dobesilas Tablets 250 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

2056 Calcium dobesilate Calcii dobesilas Tablets 250 mg AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

2057 Calcium effervescens Calcii carbonas Effervescent granules 200 mg Ca++/<br />

5g<br />

Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

2058 Calcium gluconicum Calcii gluconas Tablets 44.7 mg Ca++ Espefa Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

2059 Calcium gluconicum Calcii gluconas Tablets 45 mg Ca++ Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

2060 Calcium Gluconicum Calcii gluconas Tablets 500 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

2061 Calcium gluconicum<br />

granulatum 25 %<br />

2062 Calcium mix Wapń fosfor, magnez,<br />

z˙elazo, cynk, mangan,<br />

jod, kobalt, miedz´<br />

2063 Calcium O Smaku<br />

Cytrynowym<br />

Calcii gluconas Granules 89.4 mg Ca++/<br />

4g<br />

Tablets for veterinary<br />

use<br />

Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

30/11/05<br />

30/11/05<br />

31/07/05<br />

16/05/07<br />

31/01/06<br />

31/12/05<br />

31/01/06<br />

31/12/05<br />

31/12/05<br />

Biowet Puławy 31/12/08<br />

Syrup 114 mg /5 ml Aflofarm 31/12/08<br />

2064 Calcium pantothenicum Calcii pantothenas Tablets 100 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2065 Calcium pantothenicum Calcii pantothenas Tablets 25 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2066 Calcium Pliva Calcii glubionas Solution for injection 9 mg Ca++/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2067 Calcium Pliva Calcii lactas gluconas Effervescent tablets 177 mg Ca++ Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2068 Calcium plus Acidum ascorbicum<br />

(vit C) + Calcii lactas<br />

gluconas<br />

2069 Calcium plus Acidum ascorbicum<br />

(vit C) + Calcii lactas<br />

gluconas<br />

2070 Calcium plus Acidum ascorbicum<br />

(vit C) + Calcii lactas<br />

gluconas<br />

2071 Calcium Resonium Calcii polystyreni<br />

sulfonas<br />

2072 Calcium Syrop Calcii glubionas +<br />

Calcii lactobionas<br />

Effervescent powder 0,24g + 1,6g AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

Effervescent powder 0,24g + 1,6g AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

Effervescent powder 0,24g + 1,6g AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

oral powder or for<br />

rectal suspension<br />

Syrup 114 mg Ca++/<br />

5ml<br />

30/11/05<br />

30/11/05<br />

31/01/06<br />

31/01/06<br />

31/03/06<br />

31/03/06<br />

31/03/06<br />

1,2g Ca++/15g Sanofi Winthrop 17/11/05<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 851<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2073 Calcium-Dagomed 25<br />

odwapnienie kos´ci<br />

2074 Calciumfolinat-Ebewe,<br />

Calciumfolinat-Knoll<br />

2075 Calciumfolinat-Ebewe,<br />

Calciumfolinat-Knoll<br />

2076 Calciumfolinat-Ebewe,<br />

Calciumfolinat-Knoll 100<br />

2077 Calciumfolinat-Ebewe,<br />

Calciumfolinat-Knoll 15<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

Calcii folinas Solution for injection 10 mg/ml EBEWE Arzneimittel GmbH 30/06/05<br />

Calcii folinas Solution for injection 3 mg/1 ml EBEWE Arzneimittel GmbH 30/06/05<br />

Calcii folinas Gelatin capsules, hard 100 mg EBEWE Arzneimittel GmbH 30/06/05<br />

Calcii folinas Gelatin capsules, hard 15 mg EBEWE Arzneimittel GmbH 30/06/05<br />

2078 Calcium-Polfa 200 Calcii lactogluconas Effervescent tablets 200 mg Ca++ Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

2079 Calcium-Polfa 500 Calcii lactogluconas Effervescent powder 500 mg Ca++ Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

2080 Calcium-Sandoz + Vitamin C<br />

(Lemon)<br />

2081 Calcium-Sandoz + Vitaminum<br />

C (Orange)<br />

Acidum ascorbicum<br />

(vit C) + Calcii carbonas<br />

+ Calcii lactogluconas<br />

Acidum ascorbicum<br />

(vit C) + Calcii carbonas<br />

+ Calcii glubionas<br />

2082 Calcium-Sandoz Forte Calcii carbonas +<br />

Calcii lactogluconas<br />

2083 Calcivet Glukonian wapnia,<br />

Chlorek magnezu,<br />

Kwas borowy<br />

Effervescent tablets 1000mg +<br />

260mg Ca++<br />

Effervescent tablets 1000mg +<br />

260mg Ca++<br />

Novartis Consumer Health<br />

S.A.<br />

Novartis Consumer Health<br />

S.A.<br />

Effervescent tablets 500 mg Ca++ Novartis Consumer Health<br />

S.A.<br />

Solution for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

‘Biowet’<br />

31/05/05<br />

12/10/05<br />

31/07/04<br />

31/07/04<br />

31/07/04<br />

10/01/07<br />

2084 Calcoheel Tablets Heel GmbH 31/12/08<br />

2085 Caldetrin Calcii carbonas,<br />

Colecalciferolum<br />

Oral tablets 250 mg jonów<br />

Ca2+, 200 j.m.<br />

wit. D3<br />

2086 Calem Chlorek wapnia Emulsion for veterinary<br />

use<br />

2087 Calem plus Chlorek wapnia,<br />

cytrynian magnezu<br />

Emulsion for veterinary<br />

use<br />

Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

12/09/07<br />

Biowet Puławy 31/12/08<br />

Biowet Puławy 31/12/08<br />

2088 CALENDULA Tincture WALA-Heilmittel GmbH 24/05/07<br />

2089 Calendula Ointment Laboratoires BOIRON 31/12/07<br />

2090 Calendula fix Herb Herbapol Lublin S.A. 31/08/05<br />

2091 Calendula-Heel S Ointment Heel GmbH 31/12/08<br />

2092 Calendulatonic (poprzednia<br />

nazwa: tinctura calendulae)<br />

Calendulae flos<br />

extractum fluidum<br />

Liquid K.Z.Z. ‘Herbapol’ S.A. w<br />

Krakowie<br />

2093 Calendulin Vaginal tablets 250 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

2094 Calfit Calcii gluconolactobionicum,<br />

Calcii<br />

lactobionicum<br />

2095 Calfoset Wapnia glukonian,<br />

Wapnia<br />

glicerofosforan,<br />

Magnezu chlorek<br />

Syrup 114 mg Ca2+/<br />

5ml<br />

Solution for veterinary<br />

use<br />

31/12/08<br />

31/08/05<br />

Herbapol — Lublin S.A. 31/12/08<br />

KRKA d.d. 29/01/07


EN<br />

852 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2096 Calgam Calcii pangamas Coated tablets 50 mg Ufimskie Zakłady<br />

Witaminowe ‘UlfaWita’ S.A.<br />

2097 Calgel Cetylpyridinium +<br />

Lidocainum<br />

Gel Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

2098 Calidiol Estradiolum Nasal spray, liquid 150 mcg/1<br />

dawke˛<br />

31/12/05<br />

31/12/07<br />

Les Laboratoires Servier 8/02/06<br />

2099 Callous Acidum salicylicum Pach 400 mg/g SSL International plc 30/01/05<br />

2100 Calmagluc Glukonian wapnia ,<br />

Podfosforyn wapnia ,<br />

Chlorek magnezu ,<br />

Glukoza<br />

2101 Calmigwal Glukonian wapnia,<br />

mikroelementy<br />

2102 Calmina Lupuli flos extractum<br />

siccum + Melissae folium<br />

extractum siccum +<br />

Valerianae radix<br />

extractum siccum<br />

2103 Calmivet Acepromazyny<br />

maleinian<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Biowet Puławy Sp. z o.o. 18/09/07<br />

Biowet Puławy 31/12/08<br />

Film-coated tablets Pharbio Medical International<br />

AB<br />

Solution for veterinary<br />

use<br />

9/08/06<br />

Vetoquinol S.A. 29/03/07<br />

2104 Calperos 1000 Calcii carbonas Capsules 400 mg Ca++ Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2105 Calperos 500 Calcii carbonas Capsules 200 mg Ca++ Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2106 Calpol Paracetamolum Drops 10 % GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2107 Calpol 125 Paracetamolum Suppository 125 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2108 Calpol 6 Plus (dla dzieci<br />

powyz˙ej 6 lat)<br />

Paracetamolum Suspension 0.25 g/5 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

2109 Calpol 80 Paracetamolum Suppository 80 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2111 Calpol dla niemowla˛t i małych<br />

dzieci<br />

2110 Calpol dla niemowla˛t i małych<br />

dzieci<br />

Paracetamolum Sugar free and dyeing<br />

substance<br />

0.12 g/5 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Paracetamolum Sugar free suspension 0.12 g/5 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/03/07<br />

31/03/07<br />

31/12/08<br />

30/10/05<br />

31/12/07<br />

23/11/05<br />

31/12/07<br />

31/12/07<br />

2112 Calsynar Calcitoninum salmonis Nasal spray, solution 200 j.m./dawke˛ Rhône-Poulenc Rorer S.p.A 31/08/04<br />

2113 Calsynar Calcitoninum salmonis Solution for injection 100 j.m./1 ml A. Natterman & Cie.GmbH<br />

Rhône-Poulenc Rorer<br />

2114 Caltess Calcii carbonas Buccal tablets 750 mg Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

31/08/04<br />

31/12/08<br />

2115 Caltrate 600 Calcii carbonas Film-coated tablets 0.6 g Wyeth-Lederle 31/12/07<br />

2116 Caltrate 600 + Witamina D Calcii carbonas +<br />

Colecalciferolum<br />

Film-coated tablets Lederle Consumer Health<br />

Division American Cyanamid<br />

Company<br />

31/12/07<br />

2117 Caltrate Plus Preparat złoz˙ony Film-coated tablets Lederle Laboratories Division 30/11/04<br />

2118 Calvidin Calcii carbonas,<br />

Colecalciferolum<br />

Buccal tablets 600 mg Ca2+,<br />

400 j.m. vit.<br />

D3<br />

Rottapharm S.r.l. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 853<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2119 Calypsol Ketaminum Solution for injection 50 mg/ml Gedeon Richter Ltd. 31/05/04<br />

2120 Camesal Camphorum +<br />

Diethylamini salicylas +<br />

Mentholum<br />

2121 Camisanin F Surowica końska<br />

zawieraja˛ca przeciw<br />

ciała przeciw wirusowi<br />

nosówki<br />

Gel Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Antiserum for veterinary<br />

use<br />

2122 Campholan Ointment preparat<br />

złoz˙ony<br />

2123 Campholan D Ointment preparat<br />

złoz˙ony<br />

31/12/08<br />

Biowet Puławy 31/12/08<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

2124 Campi Powder Uzdrowisko Kopalnia Soli<br />

Bochnia Sp. z o.o.<br />

2125 Campral Acamprosatum Film-coated,<br />

gastro-resistant tablets<br />

2126 Campto Irinotecanum Concentrate for<br />

infusion<br />

2127 Campto Irinotecanum Concentrate for<br />

infusion<br />

2128 Campy-1 Szczepionka dl drobiu<br />

przeciw salmonellozie<br />

drobiu<br />

Lyophilisate for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

333 mg Lipha s.a. 31/12/08<br />

100 mg/5 ml Aventis Pharma S.A. 31/12/08<br />

40 mg/2 ml Aventis Pharma S.A. 31/12/08<br />

Biowet Puławy 31/12/08<br />

2129 Canephron N Coated tablets Bionorica Arzneimittel GmbH 31/12/08<br />

2130 Canesten Clotrimazolum Cream 10 mg/g Bayer AG 31/05/05<br />

2132 Canesten Clotrimazolum Solution for external<br />

use<br />

10 mg/ml Bayer AG 31/05/05<br />

2131 Canesten Clotrimazolum Vaginal cream 500 mg/5 g Bayer AG 11/10/06<br />

2133 Canesten Clotrimazolum Vaginal tablets 100 mg Bayer AG 31/12/08<br />

2134 Canesten Clotrimazolum Vaginal tablets 200 mg Bayer AG 31/07/04<br />

2135 Canesten Clotrimazolum Vaginal tablets 500 mg Bayer AG 31/07/04<br />

2136 Caniffa Szczepionka przeciw<br />

nosówce, zakaz˙eniom<br />

adenowirusowym i<br />

leptospirozie psów<br />

2137 Canifos Wapń, fosfor, sód,<br />

potas, magnez, z˙elazo,<br />

miedz´, cynk, magnez,<br />

białko, tłuszcz<br />

2138 Canifos junior Witamina a, d3, e,<br />

metionina, glukonian<br />

wapnia, glukonian<br />

magnezu, fosforan<br />

wapnia<br />

2139 Canigen DHA2 Szczepionka dla psów<br />

przeciw nosówce i<br />

zakaz´nemu zapaleniu<br />

wa˛troby<br />

Lyophilisate + liquid for veterinary<br />

use<br />

Tablets for veterinary<br />

use<br />

Tablets for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Merial 10/06/04<br />

Biowet Puławy 31/12/08<br />

Biowet Puławy 31/12/08<br />

Virbac 25/04/04


EN<br />

854 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2140 Canigen DHA2P/L Szczepionka dla psów<br />

przeciw nosówce,<br />

zakaz´nemu zapaleniu<br />

wa˛troby,<br />

parwowirusowej<br />

chorobie psów i<br />

leptospirozie<br />

2141 Canigen DHA2PPi/LR szczepionka dla psów<br />

przeciw nosówce,<br />

chorobie rubertha,<br />

chorobie<br />

parwowirusowej,<br />

parainfluenzie,<br />

leptospirozie i<br />

ws´ciekliz´nie<br />

2142 Canigen DHPPi Atenuowana<br />

szczepionka dla psów<br />

przeciw nosówce,<br />

zakaz´nemu zapaleniu<br />

wa˛troby,<br />

parwowirusowej<br />

chorobie psów,<br />

parainfluenzie<br />

2143 Canigen DHPPi/L Atenuowana<br />

szczepionka dla psów<br />

przeciw nosówce,<br />

zakaz´nemu zapaleniu<br />

wa˛troby,<br />

parwowirusowej<br />

chorobie psów,<br />

parainfluenzie i<br />

leptospirozie<br />

Liquid and<br />

lyophilisated<br />

component<br />

Lyophilisate + liquid<br />

component<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate + liquid for veterinary<br />

use<br />

2144 Caninsulin Insulina wieprzowa Suspension for veterinary<br />

use<br />

2145 Caniserin FHPL Surowica dla psów do<br />

biernego uodparniania<br />

przeciw nosówce,<br />

chorobie Rubartha,<br />

parwowirusowej<br />

chorobie psów i<br />

leptospirozie<br />

2146 Canivac 5/Bb Szczepionka dla psów<br />

przeciw zakaz˙eniom<br />

wywołanym wirusem<br />

nosówki,<br />

adenowirusem,<br />

parwowirusem,<br />

wirusem parainflunzy<br />

typ 2 oraz Bordetella<br />

bronchiseptica<br />

2147 Canivac 6 Szczepionka dla psów<br />

przeciwko nosówce,<br />

zakaz˙eniom<br />

adenowirusowym,<br />

parwowirozie,<br />

parainfluenzie,<br />

zakaz˙eniom Bordetella<br />

bronchiseptica oraz<br />

leptospirozie<br />

2148 Canivac FH X Szczepionka przeciw<br />

nosówce, zakaz´nemu<br />

zapaleniu wa˛troby<br />

psów, mózgu i rdzenia<br />

lisów<br />

Liquid for veterinary<br />

use<br />

Lyophilisate +<br />

suspension<br />

Lyophilisate +<br />

suspension<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Virbac 25/04/04<br />

Virbac 31/12/08<br />

Virbac S.A. 22/11/06<br />

Virbac S.A. 22/11/06<br />

Intervet 31/12/08<br />

Państwowy Instytut<br />

Weterynaryjny<br />

29/09/05<br />

Biowet Puławy 13/04/06<br />

Biowet Puławy 31/12/08<br />

Biowet Puławy 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 855<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2149 Canivac FHP Szczepionka przeciw<br />

nosówce, zakaz´nemu<br />

zapaleniu wa˛troby,<br />

chorobie<br />

parwowirusowej psów<br />

2150 Canivac L Szczepionka przeciw<br />

leptospirozie psów<br />

2151 Canivac P Szczepionka przeciw<br />

chorobie<br />

parwowirusowej psów<br />

2152 Canivac Pi Szczepionka dla psów<br />

i lisów przeciwko<br />

parwowirozie<br />

Lyophilisate for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Biowet Puławy 10/02/04<br />

Biowet Puławy 31/12/08<br />

Biowet Puławy 31/12/08<br />

Biowet Puławy 31/12/08<br />

2153 Cantharis comp. granulki WALA-Heilmittel GmbH 31/08/05<br />

2154 Cantharis comp. inj. WALA-Heilmittel GmbH 31/08/05<br />

2155 Cantharis compositum S Amp. Heel GmbH 31/12/07<br />

2156 Cantharis similiaplex krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

2157 Cantharis-Dagomed 13 stany<br />

zapalne dróg moczowych<br />

2158 Canwerm Nitroskanat, Tablet for veterinary<br />

use<br />

2159 Capastat Capreomycinum Powder for solution<br />

for intramuscular<br />

injections<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

30/11/05<br />

31/01/06<br />

30/06/04<br />

1 g Eli Lilly and Company 30/04/04<br />

2160 Capillusept Shampoo Farmina Sp. z o.o. 30/10/05<br />

2161 Capivit A + E forte Retinolum (vit A) +<br />

Tocopherolum<br />

2162 Capivit A + E mite Retinolum (vit A) +<br />

Tocopherolum<br />

Capsules, soft 2500 j.m. +<br />

150mg<br />

Capsules, soft 2500 j.m. +<br />

50mg<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2163 Capivit A forte Retinolum Capsules, soft 20000 j.m. GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2164 Capivit A mite Retinolum Capsules, soft 2500 j,m. GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2165 Capivit E 100 Tocopherolum Capsules, soft 100 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2166 Capivit E 200 Tocopherolum Capsules, soft 200 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2167 Capivit E 400 Tocopherolum Capsules, soft 400 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2168 Capivit® E Naturalny Mite Tocopherolum Capsules, soft 147 mg =<br />

200 j.m.<br />

2169 Capivit® E Naturlany Forte Tocopherolum Capsules, soft 294 mg =<br />

400 j.m.<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2170 Capsigel N Preparat złoz˙ony Cutaneous emulsion Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

2171 Capsiplex Preparat ziołowy Ointment Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

31/08/05<br />

31/08/05<br />

12/10/05<br />

12/10/05<br />

31/08/05<br />

21/06/06<br />

12/10/05<br />

31/12/08<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

2172 Captopril Captoprilum Tablets 12.5 mg P.P.H.U. Biofarm Sp. z o.o. 31/12/08


EN<br />

856 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2173 Captopril Captoprilum Tablets 12.5 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2174 Captopril Captoprilum Tablets 12.5 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/04/05<br />

12/02/06<br />

2175 Captopril Captoprilum Tablets 12.5 mg Polfarmex S.A 29/06/05<br />

2176 Captopril Captoprilum Tablets 25 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2177 Captopril Captoprilum Tablets 25 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/11/05<br />

30/10/05<br />

2178 Captopril Captoprilum Tablets 25 mg P.P.H.U. Biofarm Sp. z o.o. 31/12/08<br />

2179 Captopril Captoprilum Tablets 25 mg Polfarmex S.A 30/06/05<br />

2180 Captopril Captoprilum Tablets 50 mg P.P.H.U. Biofarm Sp. z o.o. 31/12/08<br />

2181 Captopril Captoprilum Tablets 50 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2182 Captopril Captoprilum Tablets 50 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/11/05<br />

30/10/05<br />

2183 Captopril Captoprilum Tablets 50 mg Polfarmex S.A 30/06/05<br />

2184 Captopril Captoprilum Tablets 12,5 mg Aflofarm Fabryka Leków Sp.<br />

z o.o.<br />

2185 Captopril Captoprilum Tablets 25 mg Aflofarm Fabryka Leków Sp.<br />

z o.o.<br />

2186 Captopril Captoprilum Tablets 50 mg Aflofarm Fabryka Leków Sp.<br />

z o.o.<br />

30/04/05<br />

30/04/05<br />

30/04/05<br />

2187 Captopril Captoprilum Tablets 12,5 mg Merck Generics Limited 30/04/05<br />

2188 Captopril Captoprilum Tablets 25 mg Merck Generics Limited 30/04/05<br />

2189 Captopril, Tensiomin Captoprilum Tablets 100 mg Egis Pharmaceuticals Ltd. 30/06/04<br />

2190 Captopril, Tensiomin Captoprilum Tablets 12.5 mg Egis Pharmaceuticals Ltd. 30/06/04<br />

2191 Captopril, Tensiomin Captoprilum Tablets 25 mg Egis Pharmaceuticals Ltd. 30/06/04<br />

2192 Captopril, Tensiomin Captoprilum Tablets 50 mg Egis Pharmaceuticals Ltd. 30/06/04<br />

2193 Captozid Captoprilum Tablets (50 mg+25 mg) Polfarmex Sp. z o.o. 31/12/08<br />

2194 Carbachol 3 % Carbacholum Eye drops, solution 30 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

2195 Carbenicillin Carbenicillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/11/05<br />

30/10/05<br />

2196 Carbo Compositum Amp. Heel GmbH 31/12/07<br />

2197 Carbo Medicinalis Carbo medicinalis Tablets 300mg ICN Polfa Rzeszów S.A. 30/10/05<br />

2198 Carbo medicinalis We˛giel leczniczy Granules for veterinary<br />

use<br />

ICN Polfa Rzeszów S.A. 14/02/05<br />

2199 Carbo vegetabilis Pentarkan H Tablets DHU-Arzneimittel GmbH &<br />

Co.KG<br />

2200 Carbo-Hasco Carbo medicinalis Tablets 300 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

19/03/06<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 857<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2201 Carboplatin Carboplatinum Solution for injection 10 mg/ml Pharmacia & Upjohn Pty Ltd. 31/01/05<br />

2202 Carboplatin-Ebewe,<br />

Karboplatyna-Knoll<br />

2203 Cardiactiv Crataegi inflorescentiae<br />

tinctura + Rosmarini<br />

folium tinctura<br />

Carboplatinum Concentrate for<br />

solution for<br />

intravenous infusion<br />

Oral solution (598mg +<br />

322mg)/ml<br />

10 mg/ml EBEWE Arzneimittel GmbH 30/11/04<br />

Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

25/05/05<br />

2204 Cardiacum-Heel Tablets Heel GmbH 31/12/08<br />

2205 Cardiamid-Coffein Coffeinum +<br />

Nicethamidum +<br />

Strychninum<br />

Oral drops, solution (100mg +<br />

100mg +<br />

0,25mg)/ml<br />

Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

2206 Cardiamidum Nicethamidum Oral drops, solution 250 mg/ml Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

31/12/08<br />

2207 Cardilopin Amlodipinum Tablets 10 mg Egis Pharmaceuticals Ltd. 5/07/06<br />

2208 Cardilopin Amlodipinum Tablets 2.5 mg Egis Pharmaceuticals Ltd. 5/07/06<br />

2209 Cardilopin Amlodipinum Tablets 5 mg Egis Pharmaceuticals Ltd. 5/07/06<br />

2210 Cardin 10 Simvastatinum Film-coated tablets 10 mg Schwarz Pharma Sp. z o.o. 22/02/06<br />

2211 Cardin 20 Simvastatinum Film-coated tablets 20 mg Schwarz Pharma Sp. z o.o. 22/02/06<br />

2212 Cardin 40 Simvastatinum Film-coated tablets 40 mg Schwarz Pharma Sp. z o.o. 22/02/06<br />

2213 Cardin 5 Simvastatinum Film-coated tablets 5 mg Schwarz Pharma Sp. z o.o. 22/02/06<br />

2214 Cardiobell Crataegi inflorescentiae<br />

extractum siccum<br />

Film-coated tablets 200 mg Medana Pharma Terpol<br />

Group S.A.<br />

2215 Cardiobonisan Herbal tea Bonimed Laboratorium<br />

Medycyny Naturalnej<br />

2216 Cardiobonisan Herbal tea Laboratorium Medycyny<br />

Naturalnej ‘BONIMED’,<br />

Z˙ywiec<br />

2217 Cardiobonisol Oral solution Bonimed Laboratorium<br />

Medycyny Naturalnej<br />

14/03/07<br />

5/07/05<br />

31/12/08<br />

5/03/06<br />

2218 Cardiodoron comp. krople WELEDA 24/08/05<br />

2219 Cardiofil Acidum acetylsalicylicum<br />

+ Magnesii oxydum<br />

Tablets Filofarm Farmaceutyczna<br />

Spółdzienia Pracy<br />

25/01/06<br />

2220 Cardiogran Preparat ziołowy Herbal granules Herbapol Łódz´ S.A. 31/08/05<br />

2221 Cardiol C Oral drops, solution Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

2222 Cardiomag Kalii chloridum +<br />

Magnesii oxydum<br />

Tablets 195 mg K+,<br />

75 mg Mg2+<br />

Chemiczno —<br />

Farmaceutyczna Spółdzielnia<br />

Pracy ESPEFA<br />

31/08/05<br />

30/09/07<br />

2223 Cardiomix Herba Oskar, Wierzbówiec 31/12/08<br />

2224 Cardionervit Herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

2225 Cardionervit Instant herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

2226 Cardiopirin Acidum acetylsalicylicum Tablets 0.1 g Zakłady Farmaceutyczne<br />

Colfarm<br />

30/10/05<br />

30/04/05<br />

30/11/05


EN<br />

858 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2<strong>227</strong> Cardiosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

2228 Cardiosorbid Isosorbidi dinitras Prolonged release<br />

capsules<br />

2229 Cardiosorbid Isosorbidi dinitras Prolonged release<br />

capsules<br />

20 mg ICN Polfa Rzeszów S.A. 31/01/05<br />

40 mg ICN Polfa Rzeszów S.A. 31/01/05<br />

2230 Cardiotensin 7,5 Moexiprilum Film-coated tablets 7.5 mg Schwarz Pharma AG 30/09/07<br />

2231 Cardiotensin 15 Moexiprilum Film-coated tablets 15 mg Schwarz Pharma AG 30/09/07<br />

2232 Cardiotensin Plus 15 Moeksprilum+<br />

Hydrochlorothiazidum<br />

2233 Cardiotensin Plus 7,5 Moeksprilum+<br />

Hydrochlorothiazidum<br />

2234 Cardiotonic Crataegi tinctura +<br />

Valerianae tinctura<br />

Film-coated tablets 15 mg Schwarz Pharma Sp. z o.o. 31/12/08<br />

Film-coated tablets 7,5 mg Schwarz Pharma Sp. z o.o. 31/12/08<br />

Oral solution (614mg +<br />

309mg)/ml<br />

Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

23/11/05<br />

2235 Cardiovex Preparat ziołowy Tablets 240 mg Herbapol Łódz´ S.A. 16/05/07<br />

2236 Cardioxane Dexrazoxanum Powder for solution<br />

for infusion<br />

2237 Cardiplant Film-coated tablets 15 mg<br />

procjanidyn<br />

500 mg Chiron B.V. 30/06/04<br />

Dr. Willmar Schwabe GmbH<br />

& Co.<br />

2238 Cardogard Acidum acetylsalicylicum Effervescent tablets 100 mg Natur Produkt Pharma Sp. z<br />

o.o.<br />

2239 Cardonit prolongatum 40 Isosorbidi dinitras Prolonged release<br />

tablets<br />

2240 Cardonit prolongatum 60 Isosorbidi dinitras Prolonged release<br />

tablets<br />

2241 Cardonit prolongatum 80 Isosorbidi dinitras Prolonged release<br />

tablets<br />

40 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

60 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

80 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

29/06/05<br />

31/12/08<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

2242 Cardura Doxazosinum Tablets 1 mg Pfizer GmbH 30/06/05<br />

2243 Cardura Doxazosinum Tablets 2 mg Pfizer GmbH 30/06/05<br />

2244 Cardura Doxazosinum Tablets 4 mg Pfizer GmbH 30/06/05<br />

2245 Cardura XL Doxazosinum Modified release<br />

tablets<br />

2246 Cardura XL Doxazosinum Modified release<br />

tablets<br />

2247 Carduus marianus similiaplex<br />

krople<br />

2248 CARDUUS MARIANUS/<br />

OXALIS, ampułki-<br />

2249 CARDUUS MARIANUS/<br />

OXALIS, granulki<br />

2250 CARDUUS MARIANUS/-<br />

VISCUM MALI comp., amp.<br />

2251 CARDUUS MARIANUS/-<br />

VISCUM MALI comp., gran.<br />

4 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

8 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

Pascoe Pharmaceutische<br />

Preparate GmbH<br />

31/08/04<br />

31/08/04<br />

30/11/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 859<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2252 Carident Framycetinum +<br />

Papainum<br />

Ointment (100mg +<br />

150mg)/g<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2253 Carminosol Preparat złoz˙ony Oral drops Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

2254 Carminosol Preparat złoz˙ony Syrup Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

30/11/05<br />

31/12/08<br />

31/12/08<br />

2255 Carmolis Liquid Dr. A & L Schmidgall 30/09/07<br />

2256 Carmolis japanese mint oil Oral drops Dr. A. & L. Schmidgall 31/12/08<br />

2257 Carnivit Levocarnitinum Powder for oral<br />

solution<br />

250 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2258 Carnivit Levocarnitinum Tablets 250 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2259 Carofertin Beta-karoten Solution for veterinary<br />

use<br />

14/12/05<br />

14/12/05<br />

Werft-Chemie 13/01/05<br />

2260 Carominthe Drops Lehning Laboratoires 28/02/06<br />

2261 Carplat Carboplatinum Solution for<br />

intravenous infusion<br />

2262 Carteol S.R. 1 % Carteololum Eye drops, prolonge<br />

release<br />

10 mg/ml HEXAL AG 31/12/08<br />

1 g/100 ml Laboratoire Chauvin 31/12/08<br />

2263 Cartilago comp. granulki WALA-Heilmittel GmbH 31/08/05<br />

2264 Cartilago comp. inj. WALA-Heilmittel GmbH 31/08/05<br />

2265 CARTILAGO/MANDRAGORA<br />

comp<br />

2266 CARTILAGO/MANDRAGORA<br />

comp<br />

2267 Cartrophen vet sody wielosiarczan<br />

pentozanu<br />

Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

Granules WALA-Heilmittel GmbH 24/05/07<br />

Solution for veterinary<br />

use<br />

Arthropharm LTD. 31/12/08<br />

2268 CARUM CARVI Suppository 1 g WALA-Heilmittel GmbH 24/05/07<br />

2269 Carvedilol Carvedilolum Tablets 12,5 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

<strong>227</strong>0 Carvedilol Carvedilolum Tablets 3,125 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

<strong>227</strong>1 Carvedilol Carvedilolum Tablets 6,25 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

<strong>227</strong>2 Carvedilol Carvedilolum Tablets 25 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

<strong>227</strong>3 Carvedilol Carvedilolum Tablets 6,25 mg POLFA KUTNO S.A. 31/12/08<br />

<strong>227</strong>4 Carvedilol Carvedilolum Tablets 12,50 mg POLFA KUTNO S.A. 31/12/08<br />

<strong>227</strong>5 Carvedilol Carvedilolum Tablets 25 mg POLFA KUTNO S.A. 31/12/08<br />

<strong>227</strong>6 Carvofit fix Menthae folium +<br />

Chamomillae anthodium<br />

+ Carvi fructus<br />

Herbal tea Herbapol — Białostok S.A. 31/12/07<br />

<strong>227</strong>7 Casodex Bicalutamidum Film-coated tablets 50 mg AstraZeneca UK Ltd. 31/12/07<br />

<strong>227</strong>8 Casodex Bicalutamidum Film-coated tablets 150 mg AstraZeneca UK Ltd. 31/12/07


EN<br />

860 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

<strong>227</strong>9 Caspofungin — MSD Caspofunginum Powder for<br />

concentrate for<br />

solution for infusion<br />

2280 Caspofungin — MSD Caspofunginum Powder for<br />

concentrate for<br />

solution for infusion<br />

2281 Caspofungin — MSD Caspofunginum Powder for solution<br />

form infusion + kit<br />

for infusion<br />

2282 Castagnus Agni casti fructus<br />

extractum siccum<br />

50 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

70 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

50 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

Tablets 45 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

2283 Castifem Capsules Produkcyjno-Handlowe<br />

Przedsie˛biorstwo<br />

Farmaceutyków CURTIS<br />

HEEALTHCARE Sp. z.o.o.<br />

2284 Castomix Szczepionka do<br />

czynnego<br />

uodparniania królikw<br />

przeciwko<br />

krwotocznej<br />

bronchopneumonii i<br />

myksomatozie<br />

Lyophilisate +<br />

suspension<br />

for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

6/07/05<br />

31/12/08<br />

Biowet Puławy 31/12/08<br />

2285 Castor equi Ointment Laboratoires BOIRON 27/09/07<br />

2286 Cataflam 50 Diclofenacum Film-coated tablets 50 mg Novartis Pharma AG 15/09/05<br />

2287 Catalet C Alergeny pyłków ros´lin Suspension for<br />

subcutaneous<br />

injection<br />

2288 Catalet D Alergeny pyłków ros´lin Suspension for<br />

subcutaneous<br />

injection<br />

2289 Catalet T Alergeny pyłków ros´lin Suspension for<br />

subcutaneous<br />

injection<br />

2290 Catalet z pyłku brzozy Pojedyncze alergoidy Suspension for<br />

subcutaneous<br />

injection<br />

2291 Catalin Pirenoxinum Tablets and solvent<br />

for eye drops<br />

2 ml Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

2 ml Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

2 ml Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

Wytwórnia Surowic i<br />

Szczepionek ‘BIOMED’ S.A.,<br />

Kraków<br />

0.75 mg Senju Pharmaceuticals Co.<br />

Ltd.<br />

2292 Catapresan Clonidinum Tablets 75 mcg Boehringer Ingelheim<br />

International GmbH<br />

2293 Catosal 10 % Butafosfan,<br />

Cyjanokobalamina<br />

(witamina B12)<br />

2294 CattleMaster BVD-K Szczepionka przeciw<br />

wirusowej biegunce i<br />

chorobie błon<br />

s´luzowych bydła<br />

2295 Caulophyllum-Dagomed 8<br />

zaburzenia kobiece przed<br />

menopauza˛<br />

Solution for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

30/09/05<br />

30/09/05<br />

30/09/05<br />

31/12/08<br />

31/12/07<br />

31/05/04<br />

Bayer 30/07/06<br />

Pfizer 30/06/04<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

2296 Causticum compositum Amp. Heel GmbH 31/12/08<br />

2297 Causticum Compositum Drops Heel GmbH 31/12/08<br />

2298 Caustinerf deciduous Paste Septodont 31/12/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 861<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2299 Caustinerf fort Lidocainum +<br />

Paraldehydum<br />

2300 Caveac Vitapest L Z˙ywa szczepionka dla<br />

kurcza˛t przeciw<br />

rzekomemu pomorowi<br />

drobiu<br />

Paste (370mg +<br />

460mg)/g<br />

Lyophilisate for veterinary<br />

use<br />

2301 Caverject Alprostadilum Dry substance for<br />

solution for injection<br />

2302 Caverject Alprostadilum Dry substance for<br />

solution for injection<br />

Septodont 24/07/05<br />

Ceva Sante Animale 29/09/05<br />

10 mcg Pharmacia N.V./S.A. 31/12/08<br />

20 mcg Pharmacia N.V./S.A. 31/12/08<br />

2303 Cavinton Vinpocetinum Solution for injection 5 mg/ml Gedeon Richter Ltd. 31/05/04<br />

2304 Cavinton Vinpocetinum Tablets 5 mg Gedeon Richter Ltd. 31/05/04<br />

2305 Cavinton Forte Vinpocetinum Tablets 10 mg Chemical Works of Gedeon<br />

Richter Ltd.<br />

31/12/08<br />

2306 Cc — Nefro Calcii carbonas Film-coated tablets 500 mg Salmon Pharma 31/12/08<br />

2307 Cealb Albuminum humanum Solution for<br />

intravenous infusion<br />

200 mg/ml Sanguin ClB 31/12/08<br />

2308 Ceanothus-Homaccord Amp. Heel GmbH 31/07/05<br />

2309 Ceanothus-Homaccord Drops Heel GmbH 31/07/05<br />

2310 Cebiogem Acidum ascorbicum Film-coated tablets 200 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

2312 Cebion Acidum ascorbicum<br />

(vit C)<br />

2313 Cebion Acidum ascorbicum<br />

(vit C)<br />

2314 Cebion Acidum ascorbicum<br />

(vit C)<br />

2311 Cebion Acidum ascorbicum<br />

(vit C)<br />

2315 Cebionmulti Retinolum +<br />

Riboflavinum (vit B2) +<br />

Thiaminum (vit B1)<br />

31/12/08<br />

Buccal tablet 0.1 g Merck KGaA 31/12/08<br />

Buccal tablet 0.1 g Merck KGaA 31/12/08<br />

Buccal tablet 0.1 g Merck KGaA 31/12/08<br />

Oral drops, solution 0.1 g/1 ml Merck KGaA 31/07/04<br />

Oral drops, solution Merck KGaA 31/12/08<br />

2319 Ceclor Cefaclorum Capsules 250 mg Eli Lilly Italia S.p.A. 30/04/04<br />

2320 Ceclor Cefaclorum Capsules 500 mg Eli Lilly Italia S.p.A. 30/04/04<br />

2316 Ceclor Cefaclorum Granules for oral<br />

suspension<br />

2318 Ceclor Cefaclorum Granules for oral<br />

suspension<br />

2317 Ceclor Cefaclorum Granules for<br />

suspension<br />

2321 Ceclor MR Cefaclorum Film-coated, prologed<br />

release tablets<br />

2322 Ceclor MR Cefaclorum Film-coated, prologed<br />

release tablets<br />

2323 Ceclor MR Cefaclorum Film-coated, prologed<br />

release tablets<br />

250 mg/5ml Eli Lilly Italia S.p.A. 30/04/04<br />

125 mg/5ml Eli Lilly Italia S.p.A. 30/04/04<br />

375 mg/5 ml Eli Lilly Italia S.p.A. 31/12/08<br />

375 mg Eli Lilly Italia S.p.A. 1/08/06<br />

750 mg Eli Lilly Italia S.p.A. 1/08/06<br />

500 mg Eli Lilly Italia S.p.A. 1/08/06


EN<br />

862 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2324 Cedax Ceftibutenum Capsules 400 mg Schering-Plough Italia 4/08/05<br />

2325 Cedax Ceftibutenum Powder for<br />

suspension<br />

2326 Ceel Acidum ascorbicum +<br />

Tocopheroli acetas<br />

2327 Cefabene Solanum dulcamare<br />

extractum<br />

Film-coated tablets 50 mg +<br />

100 mg<br />

36 mg/ml Schering-Plough Italia 4/08/05<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

31/12/08<br />

Ointment 100 mg/g Cefak KG 31/12/08<br />

2328 Cefadisiac Tablets CEFAK KG 19/07/07<br />

2329 Cefadolor Guajaci lignum<br />

extractum siccum<br />

Film-coated tablets 200 mg Cefak KG 31/12/08<br />

2332 Cefaleksyna Cefalexinum Capsules 250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2333 Cefaleksyna Cefalexinum Capsules 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2334 Cefaleksyna Cefalexinum Film-coated tablets 1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2330 Cefaleksyna Cefalexinum Granules for oral<br />

solution<br />

2331 Cefaleksyna Cefalexinum Granules for oral<br />

solution<br />

2335 Cefaleksyna wet. Proszek 20 % Cefalexinum Powder for veterinary<br />

use<br />

2336 Cefaleksyna wet. Tabletki<br />

250mg<br />

2337 Cefaleksyna wet. Tabletki<br />

50mg<br />

2338 Cefalgin Coffeinum +<br />

Paracetamolum +<br />

Propyphenazonum<br />

Cefalexinum Tablets for veterinary<br />

use<br />

Cefalexinum Tablets for veterinary<br />

use<br />

Tablets 50mg +<br />

250mg +<br />

150mg<br />

125 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

1/03/06<br />

30/09/05<br />

30/09/05<br />

30/09/05<br />

1/03/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/05<br />

2339 Cefamadar Oral drops CEFAK KG 19/07/07<br />

2340 Cefamadar Tablets CEFAK KG 19/07/07<br />

2341 Cefamast DC cefaleksyna,<br />

dihydrostreptomycyna<br />

2342 Cefamast LC cefaleksyna,<br />

dihydrostreptomycyna<br />

Intramammary<br />

suspension<br />

Intramammary<br />

suspension<br />

2343 Cefamezin Cefazolinum Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

2344 Cefa-Safe Cefapiryna<br />

benzatynowa<br />

Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

Bimeda 31/12/08<br />

Bimeda 31/12/08<br />

1 g Krka d.d., Novo mesto 30/04/04<br />

for veterinary<br />

use<br />

2345 Cefaseptin 120 Cefalexinum Tablet for veterinary<br />

use<br />

2346 Cefaseptin 600 Cefalexinum Tablet for veterinary<br />

use<br />

Intervet International B.V. 23/10/06<br />

Vetoquinol S.A. 30/01/06<br />

Vetoquinol S.A. 30/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 863<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2347 Cefazolin Biochemie 0,5 Cefazolinum Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

2348 Cefazolin Biochemie 1 Cefazolinum Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

2349 Cefazolin Biochemie 2 Cefazolinum Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

2350 Cefobid Cefoperazonum Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

500 mg Biochemie GmbH — Kundl 30/09/04<br />

1 g Biochemie GmbH — Kundl 30/09/04<br />

2 g Biochemie GmbH — Kundl 30/09/04<br />

1 g Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

2353 Cefor Cefaclorum Capsules 250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2354 Cefor Cefaclorum Capsules 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2351 Cefor Cefaclorum Granules for oral<br />

suspension<br />

2352 Cefor Cefaclorum Granules for oral<br />

suspension<br />

2355 CEFOTAXIM — MIP 0,5 g Cefotaximum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

2356 CEFOTAXIM — MIP 1 g Cefotaximum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

2357 CEFOTAXIM — MIP 2 g Cefotaximum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

125 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/04/04<br />

31/05/06<br />

31/05/06<br />

31/05/06<br />

31/05/06<br />

500 mg MIP Pharma Polska Sp. z o.o. 31/12/08<br />

1 g MIP Pharma Polska Sp. z o.o. 31/12/08<br />

2 g MIP Pharma Polska Sp. z o.o. 31/12/08<br />

2360 Cefprozil Cefprozilum Film-coated tablets 250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2361 Cefprozil Cefprozilum Film-coated tablets 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2358 Cefprozil Cefprozilum Powder for oral<br />

suspension<br />

2359 Cefprozil Cefprozilum Powder for oral<br />

suspension<br />

2362 Ceftazidime Ceftrazidinum Powder for solution<br />

for injection<br />

2364 CEFTRIAXON — MIP 1 g Ceftriaxonum powder and solvent<br />

for solution for<br />

intramuscular<br />

injection<br />

2363 CEFTRIAXON — MIP 1 g Ceftriaxonum Powder for solution<br />

for intravenous<br />

infusion<br />

125 mg/5 ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

250 mg/5 ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

500 mg, 1 g,<br />

2g<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

1 g CHEPHASAAR GmbH 31/12/08<br />

1 g CHEPHASAAR GmbH 31/12/08


EN<br />

864 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2365 CEFTRIAXON — MIP 2 g Ceftriaxonum Powder for solution<br />

for intravenous<br />

infusion<br />

2366 CEFTRIAXON TORREX 0,5 g Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injections<br />

2367 CEFTRIAXON TORREX 1 g Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injections<br />

2368 CEFTRIAXON TORREX 2 g Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

2369 Ceftriaxone Ceftriaxonum Powder for solution<br />

for injection<br />

2370 Cefuroxime Cefuroximum Powder for injection 250 mg,<br />

750 mg, 1,5 g<br />

2371 Cefuroxime Axetil Cefuroximum Film-coated tablets 125 mg,<br />

250 mg,<br />

500 mg<br />

2 g CHEPHASAAR GmbH 31/12/08<br />

500 mg Torrex Pharma GmbH 31/12/08<br />

1 g Torrex Pharma GmbH 31/12/08<br />

2 g Torrex Pharma GmbH 31/12/08<br />

1 g i 2 g PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2374 Cefzil Cefprozilum Film-coated tablets 250 mg Bristol-Myers Squibb S.p.A,<br />

Latina<br />

2375 Cefzil Cefprozilum Film-coated tablets 500 mg Bristol-Myers Squibb S.p.A,<br />

Latina<br />

2372 Cefzil Cefprozilum Powder for oral<br />

suspension<br />

2373 Cefzil Cefprozilum Powder for oral<br />

suspension<br />

2376 CEK Cefaclorum Granules for oral<br />

suspension<br />

2377 CEK Cefaclorum Granules for oral<br />

suspension<br />

125 mg/5 ml Bristol-Myers Squibb S.p.A,<br />

Latina<br />

250 mg/5 ml Bristol-Myers Squibb S.p.A,<br />

Latina<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

125 mg/ 5 ml Hexal AG 12/10/05<br />

250 mg/ 5 ml Hexal AG 12/10/05<br />

2378 CEK 1000 Cefaclorum Effervescent tablets 1000 mg Hexal AG 9/08/06<br />

2379 CEK 250 Cefaclorum Effervescent tablets 250 mg Hexal AG 9/08/06<br />

2380 CEK 500 Cefaclorum Effervescent tablets 500 mg Hexal AG 9/08/06<br />

2381 CEK 500 Cefaclorum Film-coated tablets 500 mg Hexal AG 9/08/06<br />

2382 Celebrex Celecoxibum Capsules 100 mg Searle Division of Monsanto<br />

plc.<br />

2383 Celebrex Celecoxibum Capsules 200 mg Searle Division of Monsanto<br />

plc.<br />

31/03/05<br />

31/03/05<br />

2384 Celestone Betamethasonum Solution for injection 4 mg/1 ml Schering-Plough Labo N.V. 31/05/04<br />

2385 Celipres 100 Celiprololum Tablets 100 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

2386 Celipres 200 Celiprololum Tablets 200 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

2387 Celipresol Celiprololum Film-coated tablets 200 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

27/06/07<br />

27/06/07<br />

31/12/08<br />

2388 Celiprol 100 Celiprololum Film-coated tablets 100 mg Leciva a.s. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 865<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2389 Celiprol 200 Celiprololum Film-coated tablets 200 mg Leciva a.s. 31/12/08<br />

2390 CellCept Mofetili mycophenolas Capsules 250 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

2393 CellCept Mofetili mycophenolas Film-coated tablets 500 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

2392 CellCept Mofetili mycophenolas Powder for<br />

concentrate for<br />

solution for infusion<br />

2391 Cellcept Mofetili mycophenolas Powder for<br />

suspension<br />

2394 Cellpest Szczepionka przeciw<br />

klasycznemu<br />

pomorowi s´wiń<br />

Lyophilisate + solvent for veterinary<br />

use<br />

500 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

1 g/5 ml F. Hoffmann — La Roche<br />

Ltd.<br />

31/12/06<br />

31/12/06<br />

31/01/05<br />

31/12/08<br />

Biowet Puławy 24/05/04<br />

2395 Centelderm Ointment Wrocławskie Zakłady<br />

Zielarskie HERBAPOL S.A.<br />

2396 Centrophenoxin Meclofenoxatum Coated tablets 100 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2397 Centrum Film-coated tablets Wyeth-Lederle Pharma GmbH<br />

Division Whitehall<br />

2398 Centrum Jr + Extra C Chewable tablets Wyeth-Lederle Pharma GmbH<br />

Division Whitehall<br />

2399 Centrum Jr + Extra Calcium Chewable tablets Wyeth-Lederle Pharma GmbH<br />

Division Whitehall<br />

31/12/08<br />

30/11/05<br />

31/07/04<br />

31/07/04<br />

31/07/04<br />

2400 Centrum Junior Buccal tablet Wyeth-Ayerst Canada 30/09/05<br />

2401 Centrum Opti Preparat złoz˙ony Film-coated tablets Lederle Laboratories Division<br />

American Cyanamid Co.<br />

31/12/08<br />

2402 Centrum Silver Film-coated tablets Wyeth-Ayerst Canada 30/04/04<br />

2403 Century Multivitamin Preparat złoz˙ony Tablets Omega Rex s.j. 31/12/08<br />

2404 Ceolat Dimeticonum Chewable tablets 80 mg Solvay Pharmaceuticals<br />

GmbH<br />

31/07/04<br />

2405 Ceolat Dimeticonum Chewable tablets 80 mg Egis Pharmaceuticals Ltd. 31/01/05<br />

2406 Cepan Preparat złoz˙ony Cream Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

2407 Cepasmel Allii cepae extractum<br />

fluidum + Allii sativi<br />

extractum fluidum<br />

2408 Cepastil Allii cepae extractum<br />

fluidum + Allii sativi<br />

extractum fluidum<br />

Syrup (613mg +<br />

123mg)/5ml<br />

Syrup (616mg +<br />

123mg)/5ml<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

Gemi Przedsie˛biorstwo<br />

Produkcji Farmaceutycznej-<br />

Przedstawiciel<br />

2409 Cephalexin Cefalexinum Capsules 500 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/01/06<br />

31/03/06<br />

31/03/06<br />

31/12/08<br />

2410 Cephalexin Cefalexinum Capsules 250 mg Pharmachim-Holding AD 30/04/04<br />

2411 Cephalexin Cefalexinum Powder for oral<br />

suspension<br />

250 mg/5ml PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2412 Cephalexin Cefalexinum Tablets 1g PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/08


EN<br />

866 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2413 Cephyl Acetylsalicylicum acidum,<br />

Coffeinum, homeopatia<br />

Tablets Laboratoires BOIRON 31/12/08<br />

2415 Cepodem Cefpodoximum Film-coated tablets 100 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

2416 Cepodem Cefpodoximum Film-coated tablets 200 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

2414 Cepodem Cefpodoximum Powder for oral<br />

suspension<br />

2417 Ceporex Cefalexinum Suspension for veterinary<br />

use<br />

2418 Cepravin Dry Cow Cefalonium Intramammary<br />

suspension<br />

40 mg/5 ml Ranbaxy Laboratoires Ltd. 31/12/08<br />

for veterinary<br />

use<br />

Schering-Plough Central Eastg 11/08/04<br />

Schering-Plough Central East<br />

Ag<br />

7/12/05<br />

2419 Cerazette Desogestrelum Film-coated tablets 0.075 mg Organon N.V. 14/02/07<br />

2420 Cereales Germees TM Drops Laboratoires BOIRON 31/12/07<br />

2421 Cereales germes compose<br />

krople<br />

Dolisos Laboratoires 31/12/08<br />

2422 CEREBELLUM comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

2423 CEREBELLUM comp. gran. WALA-Heilmittel GmbH 19/03/05<br />

2424 Cerebrolysin Solution for injection<br />

and for intravenous<br />

infusion<br />

215.2 mg/ml EBEWE Arzneimittel GmbH 31/05/05<br />

2425 Cerebrum compositum Amp. Heel GmbH 31/12/07<br />

2426 Cerebrum compositum NM Solution for injection 2,2 ml Biologische Heilmittel Heel<br />

GmbH<br />

2427 Cerezyme Powder for solution<br />

for infusion<br />

2428 Cerezyme 400 j. Powder for solution<br />

for infusion<br />

2429 Cermix iwermektyna Premix for veterinary<br />

use<br />

2430 Cernevit Lyophilisate for solution for<br />

intramuscular injection and intravenous<br />

infusion<br />

2431 Ceromangan Chlorek cerowy,<br />

chlorek magnezu,<br />

jodek potasu, jodek<br />

sodu, jod<br />

Solution for veterinary<br />

use<br />

14/03/07<br />

200 j. Genzyme B.V 12/10/05<br />

400 j. Genzyme B.V 25/04/07<br />

Biopharm 31/12/08<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

5/03/06<br />

Biowet Drwalew 31/12/08<br />

2432 Cerosel 50 Selenu zwia˛zki Tablets 50 mcg Biochefa Farmaceutyczny<br />

Zakład Naukowo-<br />

Produkcyjny<br />

2433 Ceroxim Cefuroximum Powder for oral<br />

suspension<br />

2434 Ceroxim Cefuroximum Powder for oral<br />

suspension<br />

30/01/05<br />

125 mg/5 ml Ranbaxy Laboratoires Ltd. 31/12/08<br />

250 mg/5 ml Ranbaxy Laboratoires Ltd. 31/12/08<br />

2435 Ceroxim Cefuroximum oxetilum Film-coated tablets 125 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

2436 Ceroxim Cefuroximum oxetilum Film-coated tablets 250 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

2437 Ceroxim Cefuroximum oxetilum Film-coated tablets 500 mg Ranbaxy Laboratoires Ltd. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 867<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2438 Cerubidine Daunorubicinum Lyophilisate for<br />

solution for injection,<br />

intravascular infusion<br />

2439 Cerutin Acidum ascorbicum<br />

(vit C) + Rutosidum<br />

20 mg Rhône-Poulenc Rorer Bellon 30/01/05<br />

Film-coated tablets Polfarmex S.A 24/05/06<br />

2440 Cesol Praziquantelum Film-coated tablets 150 mg Merck KGaA 31/07/04<br />

2441 Cestal Cat Prazikwantel,<br />

pyrantelu embonian<br />

2442 Cestal Plus Prazikwantel,<br />

Pyrantelu embonian,<br />

Fenbendazol<br />

Tablets for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Lavet 31/12/08<br />

Lavet Pharmaceuticals Ltd. 12/03/06<br />

2445 CetAlergin Cetirizinum Film-coated tablets 10 mg ICN Polfa Rzeszów S.A. 8/02/06<br />

2443 CetAlergin Cetirizinum Oral drops 10 mg/ml ICN Polfa Rzeszów S.A. 23/11/05<br />

2444 CetAlergin Cetirizinum Syrup 1 mg/ml ICN Polfa Rzeszów S.A. 23/11/05<br />

2446 Cetebe Acidum ascorbicum<br />

(vit C)<br />

Prolonged release<br />

capsules<br />

500 mg SmithKline Beecham<br />

Consumer Healthcare<br />

30/11/04<br />

2447 Cetiratio Cetirizinum Film-coated tablets 10 mg ratiopharm GmbH 31/12/08<br />

2448 Cetirizine Dihydrochloride,<br />

Pseudoephedrine<br />

Hydrochloride<br />

Cetirizinum +<br />

Pseudoephedrinum<br />

Capsules 5 mg, 120 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

2449 Cetix Nasal stick Cetix Spólka Przemysłowo-<br />

Handlowa z o.o. Koszalin<br />

2450 Cetix-Plus Nasal stick Cetix Spólka Przemysłowo-<br />

Handlowa z o.o. Koszalin<br />

2451 Cetolol Acebutololum Film-coated tablets 200 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2452 Cetolol Acebutololum Film-coated tablets 400 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2453 Cetriscabin Benzyli benzoas +<br />

Cetrimonii bromidum<br />

Cutaneous emulsion (30g + 0,3g)/<br />

100g<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

31/01/05<br />

31/01/05<br />

Sanofi-Synthelabo Sp. z o.o. 31/12/08<br />

2454 Cetrizen Cetirizinum Film-coated tablets 10 mg Norton Healthcare Ltd. 31/12/08<br />

2455 Cetrotide Cetrorelixum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

2456 Cetrotide Cetrorelixum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

2457 Cevac Bron 120 L Szczepionka dla<br />

kurcza˛t przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli kur.<br />

2458 Cevac Gumbo L Z˙ywa szczepionka dla<br />

kurcza˛t przeciw<br />

zakaz´nemu zapaleniu<br />

torby Fabrycjusza<br />

2459 Cevac IBD L Z˙ywa szczepionka dla<br />

kurcza˛t przeciw<br />

zakaz´nemu zapaleniu<br />

torby Fabrycjusza<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

0.25 mg/ml Ares- Serono (Europe) Ltd 31/05/05<br />

1 mg/ml Ares- Serono (Europe) Ltd 31/05/05<br />

Ceva Sante Animale 3/11/05<br />

Ceva Sante Animale 18/09/05<br />

Ceva Sante Animale 18/09/05


EN<br />

868 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2460 Cevac ND-IB-EDS-K Szczepionka dla kur<br />

przeciwko zakaz´nemu<br />

zapalenieu oskrzeli<br />

chorobie, chorobie<br />

Newcastle i<br />

syndromowi spadku<br />

nios´nos´ci<br />

2461 Cevac New L szczepionka do<br />

aktywnego<br />

uodparniania<br />

zdrowych kurcza˛t,<br />

broilerów i kur niosek<br />

przeciwko chorobie<br />

Newcastle<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

2462 Cevamec 1 % Iwermektyna Solution for veterinary<br />

use<br />

2463 C-Film Lucchini Nonoxinolum Contraceptive<br />

membrane<br />

Ceva 31/12/08<br />

Ceva Sante Animale 31/12/08<br />

Ceva Sante Animale 12/03/06<br />

72 mg Irers-Lee Ltd 27/04/05<br />

2464 Chakaem p-chlorophenolum Liquid 150 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

2465 Chamomilen Ointment Ziaja Ltd. — Zakład<br />

Produkcji Leków<br />

2466 Chamomilla similiaplex krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

2467 Chelicur Preparat złoz˙ony Liquid Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

30/10/05<br />

31/12/08<br />

30/11/05<br />

31/12/08<br />

2468 CHELIDONIUM Capsules WALA-Heilmittel GmbH 24/05/07<br />

2469 Chelidonium compose krople Dolisos Laboratoires 31/12/08<br />

2470 Chelidonium Homaccord Drops Heel GmbH 31/12/08<br />

2471 Chelidonium-Dagomed 15<br />

schorzenia wa˛troby<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

2472 Chelidonium-Homaccord Amp. Heel GmbH 31/12/08<br />

2473 Chenofalk Acidum<br />

chenodeoxycholicum<br />

Capsules 0.25 g Dr Falk Pharma GmbH 31/07/04<br />

2474 Chibroxin Norfloxacinum Eye drops 0.3 % Merck Sharp & Dohme Idea<br />

Inc.<br />

2475 China Complexe Lehning<br />

nr 107<br />

31/12/08<br />

Drops Lehning Laboratoires 11/11/06<br />

2476 China Homaccord S Amp. Heel GmbH 31/12/07<br />

2477 China-Homaccord S Drops Heel GmbH 31/12/07<br />

2478 Chinidinum prolongatum Chinidinum Prolonged release<br />

tablets<br />

200 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

2479 Chinidinum sulfuricum Chinidinum Coated tablets 200 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/11/05<br />

30/11/05<br />

2480 Chinidyny siarczan Pharma Zentrale 14/01/05<br />

2481 Chininy chlorowodorek Chininum<br />

hydrochloricum<br />

2482 Chininy chlorowodorek Chininum<br />

hydrochloricum<br />

Pharma Zentrale 14/01/05<br />

PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

14/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 869<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2483 Chinoksyzol Acidum boricum +<br />

Oxyquinolinum<br />

2484 Chiracaine Levobupivacainum Solution for injection<br />

or for concentrate for<br />

solution for infusion<br />

2485 Chirocaine Levobupivacainum Solution for injection<br />

or for concentrate for<br />

solution for infusion<br />

2486 Chirocaine Levobupivacainum Solution for injection<br />

or for concentrate for<br />

solution for infusion<br />

Tablets Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

31/01/06<br />

7.5 mg/ml Abbott S.p.A 11/10/06<br />

2.5 mg/ml Abbott S.p.A 11/10/06<br />

5 mg/ml Abbott S.p.A 11/10/06<br />

2487 Chloralu wodzian BUFA b.v. Pharmaceutical<br />

Products<br />

31/03/06<br />

2488 Chloralu wodzian Pharma Cosmetic, Kraków 31/03/06<br />

2489 Chloralu wodzian Pharma Zentrale 31/03/06<br />

2490 Chloralu wodzian Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

2491 Chloralu wodzian PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

2492 Chloramfenikol Chloramphenicolum Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

31/03/06<br />

31/03/06<br />

31/05/06<br />

2493 Chloramfenikol Pharma Cosmetic, Kraków 31/05/06<br />

2494 Chloramfenikol Pharma Zentrale 31/05/06<br />

2495 Chloramfenikol Pliva Kraków 31/05/06<br />

2496 Chloramfenikol PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/05/06<br />

2498 Chlorchinaldin Chlorquinaldolum Buccal tablet 2 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

2497 Chlorchinaldin Chlorquinaldolum Ointment 30 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

2499 Chlorchinaldin H Chlorquinaldolum +<br />

Hydrocortisonum<br />

2500 CHLORCHINALDIN O Smaku<br />

Czarnej Porzeczki<br />

Ointment (30mg +<br />

10mg)/g<br />

Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

31/01/06<br />

31/01/06<br />

Chlorquinaldolum Buccal tablets 2 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

2501 Chlorek benzalkoniowy Pharma Cosmetic, Kraków 9/04/05<br />

2502 Chlorek miedzi, 64 CuCl 2 do<br />

wstrzykiwań<br />

Preparat<br />

radiodiagnostyczny<br />

2503 Chlorek strontu — 89 SrCl 2 Preparat<br />

radiodiagnostyczny<br />

Solution for injection Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Solution for injection Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

30/04/05<br />

20/09/06<br />

2504 Chlorheksydyny octan Caesar & Loretz GmbH Caelo 31/08/05<br />

2505 Chlorocyclinum 3 % Chlortetracyclinum Ointment 30 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

2506 Chloropernazinum Prochlorperazinum Tablets 10 mg Labor Farmaceutyczno-<br />

Chemiczna Spółdzielnia Pracy<br />

31/01/06<br />

31/01/06<br />

2507 Chlorowodorek Oxybutyniny Oxybutyninum Tablets 2,5 mg Generics (UK) Limited 31/12/08


EN<br />

870 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2508 Chlorowodorek Oxybutyniny Oxybutyninum Tablets 5 mg Generics (UK) Limited 31/12/08<br />

2509 Chlorpropamid Chlorpropamidum Tablets 250 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/01/06<br />

2510 Chlorprothixen Chlorprothixenum Film-coated tablets 15 mg Lečiva a.s. 31/07/04<br />

2511 Chlorprothixen Chlorprothixenum Film-coated tablets 50 mg Lečiva a.s. 31/07/04<br />

2512 Chlorsuccillin Suxamethonium Lyophilisate for<br />

solution for injection<br />

2513 Chlortetracykliny<br />

chlorowodorek<br />

200 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

Scholz, Sowin 19/08/05<br />

2514 Cholagoga I Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 31/08/05<br />

2515 Cholagoga II Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 31/08/05<br />

2516 Cholagoga II fix Mieszanka ziołowa Instant herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

2517 Cholagoga III Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 31/08/05<br />

2518 Cholagoga III fix Mieszanka ziołowa Instant herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

2519 Cholagogum F Chelidini herba<br />

extractum siccum +<br />

Curcumae rhizomae<br />

extractum siccum<br />

2520 Cholagogum N Nattermann Curcumae radix et<br />

Chelidoni herba extr.<br />

compositum + Menthae<br />

piperitae oleum<br />

2521 Cholagomix Chelidonii herba pulv.,<br />

Teraxcaci radix cum<br />

pulv., Absinthii herba<br />

pulv.<br />

Capsuels, hard (104-131mg) +<br />

45mg<br />

Oral drops, solution (184,6mg +<br />

1,81mg) /ml<br />

Capsules, hard 168,5 mg +<br />

126 mg +<br />

85,5 mg<br />

A. Natterman & Cie.GmbH<br />

Rhone-Poulenc Rorer<br />

A. Natterman & Cie.GmbH<br />

Rhone-Poulenc Rorer<br />

31/07/04<br />

29/02/04<br />

Agropharm S.A. 31/12/08<br />

2522 Cholamid Nicotinyl methylamidum Tablets 500 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05<br />

2523 Cholamix Herba Oskar, Wierzbówiec 31/12/08<br />

2524 Cholavisol Oral solution Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

2525 Cholavit Herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

2526 Cholegran Herbal granules Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

31/12/08<br />

31/12/08<br />

31/08/05<br />

2527 Choleodoron krople WELEDA 24/08/05<br />

2528 Cholerin Triple szczepionka dla kur,<br />

indyków i ge˛si przeciw<br />

cholerze drobiu<br />

Emulsion for veterinary<br />

use<br />

Abic 31/12/08<br />

2529 Cholesana Herba Oskar, Wierzbówiec 31/12/08<br />

2530 Cholesol Oral solution Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/08/05<br />

2531 Cholesterol Pharma Cosmetic, Kraków 30/10/05<br />

2532 Cholesterol Pharma Zentrale 30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 871<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2533 Cholesterol Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

2534 Cholesterol Complexe Lehning<br />

nr 112<br />

30/10/05<br />

Drops Lehning Laboratoires 11/11/06<br />

2535 Cholestil Hymecromonum Tablets 200 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05<br />

2536 Cholestrovit Bional Pharma BV 31/12/08<br />

2537 CholiDont S Cholini salicylas Toothpaste GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2538 Cholinex Cholini salicylas Lozenge 150 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2539 Cholinex Cholini salicylas Lozenge 150 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2540 Cholitol Preparat ziołowy Oral solution Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

2541 Choragon 1500 Gonadotrophinum<br />

chorionicum<br />

2542 Choragon 5000 Gonadotrophinum<br />

chorionicum<br />

Powder and solvent<br />

for solution for<br />

injection<br />

Powder and solvent<br />

for solution for<br />

injection<br />

2543 Chorulon Gonadotropinum Lyophilisate + solvent for veterinary<br />

use<br />

2544 Chromian sodu Na 2CrO 4 do<br />

wstrzykiwań<br />

Preparat<br />

radiodiagnostyczny<br />

31/08/05<br />

31/01/06<br />

29/03/06<br />

31/03/07<br />

1500 j.m./ml Ferring GmbH 14/12/05<br />

5000 j.m./ml Ferring GmbH 14/12/05<br />

Intervet 31/12/08<br />

Solution for injection 0.02 mg/ml Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

2545 Chronocard forte Coated tablets 0.1 g Julius Redel CESRA —<br />

Arzneimittelfabrik GmbH<br />

2546 Chrono-Gest Kronolon Sponge for veterinary<br />

use<br />

31/01/06<br />

31/12/07<br />

Intervet 31/12/08<br />

2547 Chrypka HomeoPorady Laboratoires BOIRON 30/06/07<br />

2548 Chudeus-Fix Mieszanka ziołowa Instant herbal tea Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

31/01/06<br />

2549 Cialis Tadalafil Tablets 10 mg Eli Lilly and Company Ltd. 31/12/08<br />

2550 Cialis Tadalafil Tablets 20 mg Eli Lilly and Company Ltd. 31/12/08<br />

2551 Cicaderma Ointment Laboratoires Boiron 30/06/05<br />

2552 Cicaderma Ointment Laboratoires BOIRON 30/06/05<br />

2553 Cicatryl Ointment 10 mg/g Darcy Laboratories 31/07/04<br />

2554 CICHORIUM/PANCREAS<br />

comp., ampułki<br />

2555 CICHORIUM/PANCREAS<br />

comp., granulki<br />

2556 Ciclogen Ciclosporinum Capsules 10 mg, 25 mg,<br />

50 mg, 100 mg<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

GENEXO Sp.z.o.o Warszawa 31/12/08


EN<br />

872 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2557 Ciechociński Ług Leczniczy Solution for external<br />

use<br />

2558 Ciechociński Szlam Leczniczy Crystilline powder for<br />

external use<br />

Uzdrowisko Ciechocinek —<br />

Przedsie˛biorstwo Państwowe<br />

Uzdrowisko Ciechocinek —<br />

Przedsie˛biorstwo Państwowe<br />

31/12/07<br />

31/12/07<br />

2559 Cifloxin Ciprofloxacinum Tablets 250 mg Polfarmex S.A. 31/12/08<br />

2560 Cifloxin Ciprofloxacinum Tablets 500 mg Polfarmex S.A. 31/12/08<br />

2561 Cifran 250 Ciprofloxacinum Film-coated tablets 250 mg Ranbaxy Laboratories Ltd. 31/12/07<br />

2562 Cifran 500 Ciprofloxacinum Film-coated tablets 500 mg Ranbaxy Laboratories Ltd. 31/12/07<br />

2563 Cignoderm 0,1 Acidum salicylicum +<br />

Dithranolum<br />

2564 Cignoderm 0,5 Acidum salicylicum +<br />

Dithranolum<br />

2565 Cignoderm 1 Acidum salicylicum +<br />

Dithranolum<br />

2566 Cignoderm 2 Acidum salicylicum +<br />

Dithranolum<br />

2567 Cilest Ethinylestradiolum +<br />

Norgestimatum<br />

Ointment (5mg + 1mg)/g Sanofi-Synthelabo Sp. z o.o. 31/12/05<br />

Ointment (5mg + 5mg)/g Sanofi-Synthelabo Sp. z o.o. 31/12/05<br />

Ointment (5mg + 10mg)/g Sanofi-Synthelabo Sp. z o.o. 31/12/05<br />

Ointment (5mg + 20mg)/g Sanofi-Synthelabo Sp. z o.o. 31/12/05<br />

Tablets 35mcg +<br />

250mcg<br />

Cilag AG 30/06/04<br />

2568 Ciloxan Ciprofloxacinum Eye drops, solution 3 mg/ml Alcon Laboratoires Inc Texas 29/11/06<br />

2569 Cimetidine Cimetidinum Solution for infusion<br />

and for injection<br />

100 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/10/05<br />

2570 Cimetidinum Cimetidinum Film-coated tablets 100 mg ICN Polfa Rzeszów S.A. 29/11/06<br />

2571 Cimetidinum Cimetidinum Film-coated tablets 200 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

2572 Cimetidinum Cimetidinum Film-coated tablets 400 mg ICN Polfa Rzeszów S.A. 29/11/06<br />

2573 Cimicifuga complexe nr 21 Drops Lehning Laboratoires 31/03/06<br />

2574 Cimicifuga-Dagomed 9<br />

zaburzenia kobiece po<br />

menopauzie<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

2575 Cimicifuga-Homaccord Amp. Heel GmbH 31/12/07<br />

2576 Cimicifuga-Homaccord Drops Heel GmbH 31/12/07<br />

2577 Cimolan Carbocisteinum Syrup 250 mg/ 5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2578 Cimolan P Carbocisteinum Syrup 125 mg/ 5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

23/11/05<br />

23/11/05<br />

2579 Cina Complexe Nr 55 Drops Lehning Laboratoires 31/12/08<br />

2580 Cincol Naphazolinum +<br />

Zinci sulfas<br />

2581 Cinnabaris-Dagomed 3 stany<br />

zapalne atok, katar<br />

Eye drops, solution (1,0mg +<br />

2,5mg)/ml<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

30/11/05<br />

31/01/06<br />

2582 Cinnamomum-Homaccord N Amp. Heel GmbH 31/12/08<br />

2583 Cinnamomum-Homaccord N Drops Heel GmbH 31/12/08<br />

2584 Cinnarizinum Cinnarizinum Tablets 25 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/11/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 873<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2585 Cinnarizinum Cinnarizinum Tablets 25 mg Aflofarm Fabryka Leków Sp.<br />

z o.o.<br />

31/12/08<br />

2586 Cinnarizinum Cinnarizinum Tablets 25 mg Polfarmex S.A. 31/12/08<br />

2587 Cinnarizinum Cinnarizinum Tablets 25 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

2588 Ciphin Ciprofloxacinum Solution for<br />

intravenous infusion<br />

30/09/07<br />

2 mg/ml Slovakofarma a.s. 31/07/05<br />

2589 Ciphin 250 Ciprofloxacinum Film-coated tablets 250 mg Slovakofarma a.s. 31/07/05<br />

2590 Ciphin 500 Ciprofloxacinum Film-coated tablets 500 mg Slovakofarma a.s. 31/07/05<br />

2591 Ciphin 750 Ciprofloxacinum Film-coated tablets 750 mg Slovakofarma a.s. 31/07/05<br />

2593 Ciprabil Citalopramum Film-coated tablets 40 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

2594 Ciprabil Citalopramum Film-coated tablets 20 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

2592 Ciprabil Citalopramum Oral solution 2 mg / ml Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

2595 Cipralex Escitalopramum Film-coated tablets 5 mg H. Lundbeck A/S 31/12/08<br />

2596 Cipralex Escitalopramum Film-coated tablets 10 mg H. Lundbeck A/S 31/12/08<br />

2597 Cipralex Escitalopramum Film-coated tablets 15 mg H. Lundbeck A/S 31/12/08<br />

2598 Cipralex Escitalopramum Film-coated tablets 20 mg H. Lundbeck A/S 31/12/08<br />

2599 Cipramil Citalopramum Film-coated tablets 20 mg H. Lundbeck A/S 31/12/08<br />

2600 Cipramil Citalopramum Film-coated tablets 40 mg H. Lundbeck A/S 31/12/08<br />

2604 Ciprinol Ciprofloxacinum Film-coated tablets 250 mg Krka d.d., Novo mesto 30/04/04<br />

2601 Ciprinol Ciprofloxacinum Solution for<br />

intravenous infusion<br />

2602 Ciprinol Ciprofloxacinum Solution for<br />

intravenous infusion<br />

2603 Ciprinol Ciprofloxacinum Solution for<br />

intravenous infusion<br />

100 mg/50 ml KRKA d.d., Novo mesto 31/12/08<br />

200 mg/<br />

100 ml<br />

KRKA d.d., Novo mesto 31/12/08<br />

10 mg/ml Krka d.d., Novo mesto 30/04/04<br />

2605 Ciprinol 500 Ciprofloxacinum Film-coated tablets 500 mg Krka d.d., Novo mesto 30/04/04<br />

2606 Ciprobay Ciprofloxacinum Ear drops, suspension ALCON 31/12/08<br />

2607 Ciprobay Ciprofloxacinum Solution for<br />

intravenous infusion<br />

2 mg/ml Bayer AG 31/05/04<br />

2608 Ciprobay 250 Ciprofloxacinum Film-coated tablets 250 mg Bayer AG 31/05/04<br />

2609 Ciprobay 400 Ciprofloxacinum Solution for<br />

intravenous infusion<br />

400 mg/200ml Bayer AG 31/12/07<br />

2610 Ciprobay 500 Ciprofloxacinum Film-coated tablets 500 mg Bayer AG 31/05/04<br />

2611 Ciprobay Uro Ciprofloxacinum Film-coated tablets 100 mg Bayer AG 12/12/06<br />

2613 Cipronex Ciprofloxacinum Film-coated tablets 100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

2614 Cipronex Ciprofloxacinum Film-coated tablets 250 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

11/10/06<br />

30/06/06


EN<br />

874 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2615 Cipronex Ciprofloxacinum Film-coated tablets 500 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

2612 Cipronex Ciprofloxacinum Solution for<br />

intravenous infusion<br />

2 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

2616 Cipropol Ciprofloxacinum Film-coated tablets 250 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

2617 Cipropol Ciprofloxacinum Film-coated tablets 500 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

2618 Ciprum Ciprofloxacinum Concantrate for<br />

solution for infusion<br />

200 mg/20 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2619 CIPRUM 250 mg Ciprofloxacinum Film-coated tablets 250 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2620 CIPRUM 500 mg Ciprofloxacinum Film-coated tablets 500 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2621 CIPRUM 750 mg Ciprofloxacinum Film-coated tablets 750 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2622 Circadin ® Melatoninum Prolonged release<br />

tablets<br />

2 mg Neurim Pharmaceuticals EEC<br />

Ltd.<br />

30/06/06<br />

4/07/07<br />

30/06/06<br />

30/09/07<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

2623 Circulo-Injeel Amp. Heel GmbH 31/12/08<br />

2624 Circulosan fix Instant herbal tea Herbapol Lublin S.A. 31/08/05<br />

2625 Circused Valerianae radix<br />

extractum siccum<br />

2626 Cirrus Cetirizinum +<br />

Pseudoefedrinum<br />

2627 Cirrus Cetirizinum +<br />

Pseudoephedrinum<br />

Coated tablets Roha Arzneimittel GmbH 31/12/08<br />

Prolonged release<br />

tablets<br />

5mg +<br />

120 mg<br />

UCB Pharma S.A. 31/12/08<br />

Capsules UCB S.A. Pharma Sector 31/03/04<br />

2628 Cisap Cisapridum Tablets 10 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

2629 Cisap Cisapridum Tablets 20 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

2630 Cisap Cisapridum Tablets 5 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

2631 Cisplatin-Ebewe, Cisplatin-<br />

Knoll<br />

8/02/06<br />

8/02/06<br />

8/02/06<br />

Cisplatinum Solution for injection 0.5 mg/ml EBEWE Arzneimittel GmbH 30/06/04<br />

2632 Cisplatinum Cisplatinum Vial 10 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2633 Cisplatinum Cisplatinum Vial 50 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2634 Cisplatinum Cisplatinum Vial 25 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2635 Cisporal Ciclosporinum Solution for<br />

oromucosal use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

100 mg/ml HEXAL AG 31/12/08<br />

2636 Cisporal 100 Ciclosporinum Capsules 100 mg HEXAL AG 31/12/08<br />

2637 Cisporal 25 Ciclosporinum Capsules 25 mg HEXAL AG 31/12/08<br />

2638 Cisporal 50 Ciclosporinum Capsules 50 mg HEXAL AG 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 875<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2639 Cistus canadensis complexe<br />

nr 86<br />

Drops Lehning Laboratoires 4/01/07<br />

2640 Cital Citalopramum Film-coated tablets 20 mg Biovena Pharma Sp. z o.o. 9/08/06<br />

2641 Citalec 10 Citalopramum Film-coated tablets 10 mg Leciva a.s. 31/12/08<br />

2642 Citalec 20 Citalopramum Film-coated tablets 20 mg Leciva a.s. 31/12/08<br />

2643 Citalec 40 Citalopramum Film-coated tablets 40 mg Leciva a.s. 31/12/08<br />

2644 Citalopram Citalopramum Tablets 20 mg, 40 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

2645 Citaratio Citalopramum Film-coated tablets 20 mg ratiopharm GmbH 31/12/08<br />

2646 Citocartin 100 Articainum +<br />

Epinephrinum<br />

2647 Citocartin 200 Articainum +<br />

Epinephrinum<br />

Solution for injection (40mg +<br />

10mcg)/ml<br />

Solution for injection (40mg +<br />

5mcg)/ml<br />

Molteni Dental S.r.I 31/12/08<br />

Molteni Dental S.r.I 31/12/08<br />

2648 Citrokehl iniekcje Sanum-Kehlbeck 31/12/05<br />

2649 Citrokehl krople Sanum-Kehlbeck 31/12/05<br />

2650 Citrolyt Acidum citricum + Kalii<br />

citras + Natrii citras<br />

2651 Citropepsin Acidum citricum +<br />

Pepsinum<br />

2652 CITRUS E FRUCTIBUS/<br />

CYDONIA E FRUCTIBUS D2/2<br />

amp.<br />

Granules for oral<br />

solution<br />

2653 Claforan Cefotaximum Powder for solution<br />

for intravascular<br />

injection and infusion<br />

2654 Clamoxyl L.A. Amoxicillunum Suspension for veterinary<br />

use<br />

2655 Clamoxyl Proszek<br />

rozpuszczalny<br />

Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

31/01/06<br />

Oral solution ICN Polfa Rzeszów S.A. 31/01/06<br />

Amoxicillunum Soluble powder for veterinary<br />

use<br />

2656 Clamoxyl Tabletki 200 mg Amoxicillunum Tablet for veterinary<br />

use<br />

2657 Clamoxyl Tabletki 40 mg Amoxicillunum Tablet for veterinary<br />

use<br />

2658 Clanohepar Klanobutin Solution for veterinary<br />

use<br />

2659 Clarinase Loratadinum +<br />

Pseudoephedrinum<br />

Prolonged release<br />

tablets<br />

WALA-Heilmittel GmbH 19/03/05<br />

1 g Laboratories Roussel 30/04/04<br />

Pfizer Inc. 24/06/07<br />

Pfizer Italia S.r.I. 4/03/04<br />

Pfizer Italia S.r.I. 4/03/04<br />

Pfizer Italia S.r.I. 4/03/04<br />

Biowet Puławy 31/12/08<br />

Schering-Plough Labo N.V. 8/04/07<br />

2660 Clarithromycin Clarithomycinum Syrup 125 mg /5ml PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2661 Clarithromycin Clarithomycinum Tablets 250 mg,<br />

500 mg<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/08<br />

2662 Claritine Loratadinum Syrup 1 mg/ml Schering-Plough Labo N.V. 31/05/05<br />

2663 Claritine Loratadinum Tablets 10 mg Schering-Plough Labo N.V. 31/05/04<br />

2664 Clarix® Loratadinum Tablets 10 mg HEXAL Polska Sp. z o.o. 31/12/08


EN<br />

876 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2665 Clearasil Ultra 10 Benzoylis peroxydum Gel 100 mg/g Boots Healthcare<br />

International<br />

2666 Clemastatinum Clemastatinum Syrup 0,5 ml / 5ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

2667 Clemastatinum Clemastatinum Tablets 1 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

2668 Clemastinum Clemastinum Solution for injection 1 mg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

2669 Clemastinum Clemastinum Syrup 0.5 mg/ 5 ml Aflofarm Farmacia Polska Sp.<br />

z o.o.<br />

2670 Clemastinum Clemastinum Syrup 1 mg/10 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

2671 Clemastinum Clemastinum Tablets 1 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

2672 Clemastinum Clemastinum Tablets 1 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

2673 Clexane Enoxaparinum natricum Solution for<br />

subcutaneous<br />

injection<br />

2674 Clexane Enoxaparinum natricum Solution for<br />

subcutaneous<br />

injection<br />

2675 Clexane Enoxaparinum natricum Solution for<br />

subcutaneous<br />

injection<br />

2676 Clexane Enoxaparinum natricum Solution for<br />

subcutaneous<br />

injections or for<br />

arterial line of<br />

dialyzator<br />

2677 Clexane Enoxaparinum natricum Solution for<br />

subcutaneous<br />

injections or for<br />

arterial line of<br />

dialyzator<br />

2678 Clexane Enoxaparinum natricum Solution for<br />

subcutaneous<br />

injections or for<br />

arterial line of<br />

dialyzator<br />

2679 Clexane forte Enoxaparinum natricum Solution for<br />

subcutaneous<br />

injections or for<br />

arterial line of<br />

dialyzator<br />

2680 Clexane forte Enoxaparinum natricum Solution for<br />

subcutaneous<br />

injections or for<br />

arterial line of<br />

dialyzator<br />

16/04/06<br />

31/12/08<br />

31/12/08<br />

30/11/05<br />

27/06/07<br />

30/11/05<br />

30/11/05<br />

31/12/08<br />

100 mg/1 ml Rhône-Poulenc Rorer Bellon 31/12/08<br />

60 mg/0,6 ml Rhône-Poulenc Rorer Bellon 31/12/08<br />

80 mg/0,8 ml Rhône-Poulenc Rorer Bellon 31/12/08<br />

100 mg /1 ml (<br />

300mg /3ml)<br />

2681 Climara-100 Estradiolum Transdermal patch 7.6 mg,<br />

100mcg/24h<br />

Rhône-Poulenc Rorer Bellon 31/12/04<br />

40 mg/0,4 ml Rhône-Poulenc Rorer Bellon 30/04/04<br />

20 mg/0,2 ml Rhône-Poulenc Rorer Bellon 30/04/04<br />

120 mg/0,8 ml Aventis Pharma 5/07/06<br />

150 mg/ml Aventis Pharma 5/07/06<br />

Schering AG 31/12/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 877<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2682 Climara-50 Estradiolum Transdermal patch 3.8 mg,<br />

50mcg/24h<br />

Schering AG 31/12/04<br />

2683 Climaxol Drops Lehning Laboratoires 31/12/08<br />

2684 Climen Cyproteronum +<br />

Estradiolum<br />

2685 CLINACOX 0,5 % PREMIX Diklazuril Premix for veterinary<br />

use<br />

Film-coated tablets Schering AG 31/12/08<br />

Janssen Pharmaceutica<br />

Animal Health<br />

31/12/08<br />

2686 Clindacin Clindamycinum Capsules 300 mg Lannacher Heilmittel GmbH 31/12/08<br />

2687 Clindacne Clindamycini phosphas Gel 10 mg/g Homeofarm Sp. z o.o.<br />

Laboratorium<br />

Farmaceutyczne<br />

2688 Clindasan (Clindamycin Mip) Clindamycinum Solution for<br />

intramuscular<br />

injection<br />

2689 Clindasan 150 (Clindamycin<br />

Mip)<br />

2690 Clindasan 300 (Clindamycin<br />

Mip)<br />

2691 Clindasan 600 (Clindamycin<br />

Mip)<br />

6/12/06<br />

150 mg/ml CHEPHASAAR GmbH 31/12/08<br />

Clindamycinum Film-coated tablets 150 mg CHEPHASAAR GmbH 31/12/08<br />

Clindamycinum Film-coated tablets 300 mg CHEPHASAAR GmbH 31/12/08<br />

Clindamycinum Film-coated tablets 600 mg CHEPHASAAR GmbH 31/12/08<br />

2692 Clindo Clindamycinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

150 mg/ml Hexal AG 20/06/07<br />

2693 Clindo 300 Clindamycinum Capsules 300 mg Hexal AG 21/03/07<br />

2694 Clinimix N12G 20E Preparat złoz˙ony Kit: 2 solutions for<br />

intravenous infusion<br />

2695 Clinimix N14G 30E Preparat złoz˙ony Kit: 2 solutions for<br />

intravenous infusion<br />

2696 Clinimix N17G 35E Preparat złoz˙ony Kit: 2 solutions for<br />

intravenous infusion<br />

2697 Clinimix N9G 15E Preparat złoz˙ony Kit: 2 solutions for<br />

intravenous infusion<br />

2698 Clinimix N9G 20E Preparat złoz˙ony Kit: 2 solutions for<br />

intravenous infusion<br />

Baxter Healthcare Ltd. 31/12/08<br />

Baxter Healthcare Ltd. 31/12/08<br />

Baxter Healthcare Ltd. 31/12/08<br />

Baxter Healthcare Ltd. 31/12/08<br />

Baxter Healthcare Ltd. 31/12/08<br />

2699 Clinofug® D 50 Doxycyclinum Tablets 50 mg Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

2700 ClinOleic 20 % Oleum Olivae + Oleum<br />

Sojae<br />

2701 Clinomel N 4-550 Kit: 2 solutions and<br />

emulsion for infusion<br />

2702 Clinomel N 5-800 Kit: 2 solutions and<br />

emulsion for infusion<br />

2703 Clinomel N 6-900 Kit: 2 solutions and<br />

emulsion for infusion<br />

Emulsion for infusion Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

31/12/08<br />

29/08/07<br />

14/12/05<br />

14/12/05<br />

14/12/05


EN<br />

878 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2704 Clinomel N 7-1000 Kit: 2 solutions and<br />

emulsion for infusion<br />

2705 Clivarin 1432 Reviparinum natricum Solution for<br />

subcutanous injection<br />

2706 CLIVARIN Multi Reviparinum natricum Solution for<br />

subcutanous injection<br />

2707 Clivarin® 3436 Reviparinum natricum Solution for<br />

subcutanous injection<br />

1432 j.m. AXa/<br />

0,25ml<br />

34356 j.m.<br />

anty X — a/<br />

6ml<br />

3 436 j.m./aXa/<br />

0,6 ml<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

14/12/05<br />

Abbott GmbH & Co KG 20/09/06<br />

Abbott GmbH & Co. KG 31/12/08<br />

Abbott GmbH & Co. KG 31/12/08<br />

2708 Clobederm Clobetasolum Cream 500 mcg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2709 Clobederm Clobetasolum Ointment 500 mcg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

25/01/06<br />

25/01/06<br />

2710 Clodran 400 Natrii clodronas Film-coated tablets 400 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

2711 Clodran 800 Natrii clodronas Film-coated tablets 800 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

2712 Clonazepamum Clonazepamum Solution for injection 1 mg/1 ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2713 Clonazepamum Clonazepamum Tablets 0.5 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2714 Clonazepamum Clonazepamum Tablets 2 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

2715 Clonistada 0,15 Clonidinum Tablets 0.15 mg Stada Arzneimittel AG 30/06/04<br />

2716 Clopamid Clopamidum Tablets 20 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

2717 Clophelin Clonidinum Tablets 0,075 mg ORGANICA S.A. 31/12/08<br />

2718 Clopidix Clopigrelum Film-coated tablets 75 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

31/12/08<br />

2719 Clopidogrel Clopidogrelum Film-coated tablets 75 mg POL-NIL Sp. z.o.o. 31/12/08<br />

2720 Clopidogrel Clopidogrelum Film-coated tablets 75 mg Adamed Sp. z o.o. 31/12/08<br />

2721 Clopixol Zuclopenthixolum Film-coated tablets 10 mg H. Lundbeck A/S 30/06/04<br />

2722 Clopixol Zuclopenthixolum Film-coated tablets 25 mg H. Lundbeck A/S 30/06/04<br />

2723 Clopixol-Acuphase Zuclopenthixolum Solution for injection 50 mg/1 ml H. Lundbeck A/S 30/06/04<br />

2724 Clopixol-Depot Zuclopenthixolum Solution for injection 200 mg/ml H. Lundbeck A/S 30/06/04<br />

2725 Cloradine Loratadinum Oral tablets 10 mg Polfarmex Sp. z o.o. 31/12/08<br />

2726 Cloranxen Dikalii clorazepas Tablets 10 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2727 Cloranxen Dikalii clorazepas Tablets 5 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

2728 Clostilbegyt Clomifenum Tablets 50 mg Egis Pharmaceuticals Ltd. 30/06/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 879<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2729 Clostriporc Coli Szczepionka dla s´wiń<br />

przeciw<br />

kolibakteriozie i<br />

zakaz´nemu<br />

martwicowemu<br />

zapaleniu jelit u<br />

prosia˛t<br />

2730 Clostrivax Szczepionka dla bydła<br />

i owiec przeciwko<br />

schorzeniom<br />

wywoływanym przez<br />

drobnoustroje z<br />

rodzaju clostridium<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Impfstoffwerk Dessau-Tornau<br />

GmbH<br />

27/11/05<br />

Fatro Włochy 31/12/08<br />

2731 Clotrimazol Clotrimazolum Vaginal tablets 100 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

2732 Clotrimazol Clotrimazolum Vaginal tablets 200 mg Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

2733 Clotrimazol Clotrimazolum Vaginal tablets 500 mg Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

2741 Clotrimazolum Clotrimazolum Coutanous solution 10 mg/ml Medana Pharma Terpol<br />

Group S.A.<br />

2734 Clotrimazolum Clotrimazolum Cream 1 % Przedsiebiorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego ‘CEFARM’<br />

2735 Clotrimazolum Clotrimazolum Cream 1 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

2736 Clotrimazolum Clotrimazolum Cream 10 mg/g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2737 Clotrimazolum Clotrimazolum Cream 10 mg/g Homeofarm Sp. z o.o.<br />

Laboratorium<br />

Farmaceutyczne<br />

2738 Clotrimazolum Clotrimazolum Cream 10 mg/g Ziaja Ltd. — Zakład<br />

Produkcji Leków<br />

2739 Clotrimazolum Clotrimazolum Cream 10 mg/g Aflofarm Farmacia Polska Sp.<br />

z o.o.<br />

2740 Clotrimazolum Clotrimazolum Eye ointment 1 % Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2742 Clotrimazolum Clotrimazolum Vaginal tablets 100 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2743 Clotrimazolum Clotrimazolum Vaginal tablets 500 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2744 Clotrimazolum 1 % Clotrimazolum Cream 1 % Laboratorium Galenowe<br />

‘LEFARM’ Sp. z o.o.<br />

2745 Cloxa Coli Sól sowowa<br />

Koloksacyliny,<br />

Siarczan Kolistyny<br />

2746 Cloxa Coli Injector Sól sowowa<br />

Koloksacyliny,<br />

Siarczan Kolistyny<br />

2747 Cloxacillin benzathine<br />

1000 mg T.S<br />

Intramammary<br />

suspension<br />

Intramammary<br />

suspension<br />

Cloxacillinum Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/05/05<br />

30/10/05<br />

31/08/05<br />

31/12/08<br />

30/04/05<br />

31/12/05<br />

31/05/05<br />

31/12/08<br />

Virbac S.A. 19/06/05<br />

Virbac S.A. 19/06/05<br />

CP-Pharma 31/12/08


EN<br />

880 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2748 Cloxamed-TS Cloxacillinum Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

aniMedica 14/06/04<br />

2749 Clozapine 25 Clozapinum Tablets 25 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2750 Clozapine 50 Clozapinum Tablets 50 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2751 Co — Diovan® Valsartanum +<br />

Hydrochlorothiazidum<br />

Film-coated tablets 160 mg +<br />

25 mg<br />

31/01/05<br />

31/01/05<br />

Novartis Pharma AG 31/12/08<br />

2752 Co Q10 Ubidecarenonum Capsules, hard 30 mg PRO NATURA s.j. 31/12/08<br />

2753 Coaparin Heparicum Solution for<br />

subcutanous injection<br />

2754 CoAprovel Hydrochlorothiazidum +<br />

Irbesartanum<br />

2755 CoAprovel Hydrochlorothiazidum +<br />

Irbesartanum<br />

5 000 j.m. /<br />

0,2 ml<br />

Tablets 12,5mg +<br />

150mg<br />

Tablets 12,5mg +<br />

300mg<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

Sanofi Pharma BMS SNC 31/05/05<br />

Sanofi Pharma BMS SNC 31/05/05<br />

2756 Coaxil Tianeptinum Film-coated tablets 12.5 mg Les Laboratoires Servier 30/09/05<br />

2757 Cobactan Cefquinom (siarczan) Suspension for veterinary<br />

use<br />

2758 Cobactan LC Cefquinom (siarczan) Intramammary<br />

suspension<br />

2759 Cobaphos Sól sodowa a —<br />

oksybenzylofosfinianu,<br />

cjanokobalamina<br />

for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

2760 Cocarboxylasum Cocarboxylasum Powder and solvent<br />

for solution for<br />

injection<br />

2761 Cocarboxylasum Cocarboxylasum Powder and solvent<br />

for solution for<br />

injection<br />

Intervet International 20/12/06<br />

Intervet International B.V. 23/10/06<br />

Richter Pharma 31/12/08<br />

50 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

50 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/01/05<br />

31/01/05<br />

2762 Cocculine Tablets Laboratoires BOIRON 31/12/07<br />

2763 Cocculus Complexe nr 73 Drops Lehning Laboratoires 4/01/07<br />

2764 Cocculus-Dagomed 21<br />

choroba lokomocyjna<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

2765 Cocculus-Hmaccord Drops Heel GmbH 31/12/08<br />

2766 Cocculus-Homaccord Amp. Heel GmbH 31/12/08<br />

2767 Cocois Ointment Bioglan Laboratories Ltd. 31/12/04<br />

2768 Cod Liveer Oil Jecoris Aselii oil Capsules, soft 425 mg PRO NATURA s.j. 31/12/08<br />

2769 Cod Liver Oil Capsules 0.275 g Power Health Products Ltd. 31/07/04<br />

2770 Cod Liver Oil Capsules Lifeplan Products Ltd. 30/04/04<br />

2771 Cod Liver Oil Double Strenght Jecoris Aselli oil Capsules, soft 650 mg PRO NATURA s.j. 31/12/08<br />

2772 Codeinum phosphoricum Codeinum Tablets 20 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2773 Codespan forte Codeinum +<br />

Paracetamolum<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/05/05<br />

30/04/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 881<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2774 Co-Diovan Hydrochlorothiazidum +<br />

Valsartanum<br />

2775 Co-Diovan Hydrochlorothiazidum +<br />

Valsartanum<br />

Film-coated tablets 80mg +<br />

12,5mg<br />

Film-coated tablets 160mg +<br />

12,5mg<br />

Novartis Pharma AG 30/11/04<br />

Novartis Pharma AG 29/03/06<br />

2777 Codipar Paracetamolum Effervescent tablets 500 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2776 Codipar Paracetamolum Tablets 500 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2778 Codipar 250 Paracetamolum Suppository 250 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2779 Codipar 500 Paracetamolum Suppository 500 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2780 Codipar Ultra Paracetamolum +<br />

Codeinum<br />

2781 Codipar® Plus Paracetamolum +<br />

Coffeinum<br />

Film-coated tablets 500 mg ,<br />

10 mg<br />

Film-coated tablets 500 mg +<br />

65 mg<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

27/06/07<br />

31/12/05<br />

31/01/06<br />

31/12/05<br />

31/12/08<br />

31/12/08<br />

2782 Coenzym Q 10 Ubidecarenonum Capsules 10 mg Pharmacaps Inc, USA 31/12/08<br />

2783 Coenzym Q 10 Ubidecarenonum Capsules 10 mg Puritan's Pride Inc., USA 31/12/08<br />

2784 Coenzyme compositum Amp. Heel GmbH 31/12/07<br />

2785 Coffecorn forte Coffeinum +<br />

Ergotaminum<br />

2786 Coffecorn mite Coffeinum +<br />

Ergotaminum<br />

2787 Coffeinum Natrium benzoicum Caffeinum et natrii<br />

benzoas<br />

Coated tablets Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

Coated tablets Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

Tablets 200 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

2788 Coffeinum Natrium Benzoicum Solution for injection Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

2789 Coffeinum Natrium Benzoicum Coffeinum + Natrii<br />

benzoas<br />

2790 Coffepar Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Paracetamolum<br />

2791 Coffepirine -tabletki od bólu<br />

głowy<br />

Acidum acetylsalicylicum<br />

+ Coffeinum<br />

2792 Cofferan Dekstran z˙elaza,<br />

siarczan miedzi,<br />

witamina B12<br />

Liquid for veterinary<br />

use<br />

30/01/05<br />

31/01/06<br />

30/11/05<br />

31/12/05<br />

Biowet Puławy 24/05/04<br />

Tablets Marcmed s.c. 31/03/06<br />

Tablets Marcmed s.c. 31/12/08<br />

Solution for veterinary<br />

use<br />

Biowet Puławy 31/12/08<br />

2793 Cogiton 10 Donepezilum Film-coated tablets 10 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

2794 Cogiton 5 Donepezilum Film-coated tablets 5 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

2795 COLCHICUM comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

2796 COLCHICUM comp. gran. WALA-Heilmittel GmbH 19/03/05<br />

2797 COLCHICUM comp. ung. WALA-Heilmittel GmbH 19/03/05<br />

2798 Colchicum compositum<br />

forte S<br />

2799 Colchicum compositum medium<br />

S<br />

Amp. Heel GmbH 31/12/08<br />

Amp. Heel GmbH 31/12/08


EN<br />

882 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2800 Colchicum compositum<br />

mite S<br />

Amp. Heel GmbH 31/12/08<br />

2801 Colchicum-Dispert Colchicinum Coated tablets 0.5 mg Solvay Pharmaceuticals<br />

GmbH<br />

2802 Coldrex Broncho Guaifenesinum Syrup 100 mg/5ml SmithKline Beecham<br />

Consumer Healthcare<br />

2803 Coldrex HotRem o smaku<br />

cytrynowym<br />

2804 Coldrex HotRem o smaku<br />

czarnej porzeczki<br />

2805 Coldrex Laryplus (o smaku<br />

cytrynowym)<br />

2806 Coldrex Laryplus (o smaku<br />

czarnej porzeczki)<br />

2807 Coldrex MaxGrip o smaku<br />

cytrynowym<br />

Acidum ascorbicum<br />

(vit C) + Paracetamolum<br />

+ Phenylephrinum<br />

Acidum ascorbicum<br />

(vit C) + Paracetamolum<br />

+ Phenylephrinum<br />

Benzalkonium +<br />

Hexylresorcinolum<br />

Benzalkonium +<br />

Hexylresorcinolum<br />

Acidum ascorbicum<br />

(vit C) + Paracetamolum<br />

+ Phenylephrinum<br />

2808 Coldrex Nite Dextromethorphanum +<br />

Paracetamolum +<br />

Promethazinum<br />

powder for solution (70mg +<br />

750mg +<br />

10mg)/5g<br />

powder for solution (70mg +<br />

750mg +<br />

10mg)/5g<br />

Buccal tablet 1,2mg +<br />

2,5mg<br />

Buccal tablet 1,2mg +<br />

2,5mg<br />

powder for solution 40mg +<br />

1000mg +<br />

10mg<br />

Syrup (15mg +<br />

1000mg +<br />

20mg)/20ml<br />

SmithKline Beecham<br />

Consumer Healthcare<br />

SmithKline Beecham<br />

Consumer Healthcare<br />

SmithKline Beecham<br />

Consumer Healthcare<br />

SmithKline Beecham<br />

Consumer Healthcare<br />

SmithKline Beecham<br />

Consumer Healthcare Glaxo<br />

SmithKline Export Ltd.<br />

SmithKline Beecham<br />

Consumer Healthcare<br />

2809 Coldrex Tablets Preparat złoz˙ony Tablets SmithKline Beecham<br />

Consumer Healthcare<br />

2810 Colepectin Pectinum Granules 97.7 g/100 g Zakłady Farmaceutyczne<br />

Colfarm<br />

2811 Colestid Colestipolum Granules for oral<br />

suspension<br />

2812 Colipate Collistinum Paste for veterinary<br />

use<br />

2813 Coliporc Plus Inaktywowana<br />

szczepionka dla s´wiń<br />

przeciw<br />

kolibakteriozie<br />

Suspension for veterinary<br />

use<br />

2814 Colisol 2400 Collistinum Powder for veterinary<br />

use<br />

2815 Colisorb Szczepionka dla s´wiń<br />

przeciwko<br />

kolibakteriozie prosia˛t<br />

i róz˙ycy<br />

2816 Colistin Colistimethatum<br />

natricum<br />

2817 Colistin Colistimethatum<br />

natricum<br />

Suspension for veterinary<br />

use<br />

Lyophilisate for<br />

solution for<br />

intravenous and<br />

intramuscular<br />

injection<br />

Lyophilisate for<br />

solution for<br />

intravenous and<br />

intramuscular<br />

injection<br />

2818 Colistin 10 % Meiji Collistinum Premix for veterinary<br />

use<br />

31/07/04<br />

31/08/04<br />

30/06/04<br />

30/06/04<br />

30/06/05<br />

13/09/06<br />

29/08/07<br />

30/11/04<br />

31/07/04<br />

31/12/07<br />

5 g Pharmacia N.V./S.A. 30/06/04<br />

Vorbac 31/12/08<br />

Impfstoffwerk Dessau-Tornau<br />

GmbH<br />

12/03/06<br />

Lavet 31/12/08<br />

Hoechst Russel 31/12/08<br />

1000000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

500000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/03/05<br />

31/03/05<br />

Meiji Seika Kaisha 30/06/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 883<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2819 Colistin 2 % Meiji Collistinum Granules for veterinary<br />

use<br />

2820 Colisuin CL szczepionka<br />

inaktywowana przeciw<br />

zakaz˙eniom e. coli<br />

oraz cl. perfringens<br />

2822 Colitan Mesalazinum Gastro-resistant<br />

tablets<br />

Emulsion for veterinary<br />

use<br />

Meiji Seika Kaisha 30/06/04<br />

Hipra 31/12/08<br />

250 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2821 Colitan Mesalazinum Suppository 250 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2823 Colivac S-2 Szczepionka przeciw<br />

kolibakteriozie s´wiń<br />

Suspension for veterinary<br />

use<br />

2824 Colivet Collistinum Powder for veterinary<br />

use<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

14/02/07<br />

9/08/06<br />

31/12/08<br />

Ceva Sante Animale 10/02/07<br />

2825 Colnadul Drops Heel GmbH 31/07/05<br />

2826 Colocynthis-Homaccord Amp. Heel GmbH 31/12/08<br />

2827 Colocynthis-Homaccord Drops Heel GmbH 31/12/08<br />

2828 Colvital Tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

2829 Comarol Diphenhydraminum +<br />

Lidocainum<br />

2830 Combi-Ject Benzylpenicillinum<br />

procainicum +<br />

Dihydrostreptomycinum<br />

2831 Combimink P Szczepionka dla norek<br />

przeciw zakaz´nemu<br />

zapaleniu jelit,<br />

botulizmowi i<br />

zakaz˙eniom<br />

wywołanym przez<br />

Pseudomonas<br />

aeruginosa<br />

2832 Combivent Ipratropii bromidum +<br />

Salbutamolum<br />

2833 Combivir Lamivudinum +<br />

Zidovudinum<br />

2834 Combivit Witamina B1,<br />

Witamina B2,<br />

Witamina B6,<br />

Witamina C,<br />

Nikotynamid<br />

2835 Combizym Amylasum + Lipasum +<br />

Proteasum<br />

Cream (20mg +<br />

10mg)/g<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Pressurised inhalation,<br />

suspension<br />

(0,021mg +<br />

0,12mg)/dawke˛<br />

Film-coated tablets 150mg +<br />

300mg<br />

Solution for veterinary<br />

use<br />

30/10/05<br />

Sanofi-Synthelabo Sp. z o.o. 30/10/05<br />

Dopharma 31/12/08<br />

United Vaccines 15/05/06<br />

Boehringer Ingelheim<br />

International GmbH<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/12/04<br />

31/10/04<br />

Norbrook 31/12/08<br />

Film-coated tablets 220 mg Sankyo Pharma GmbH 31/07/04<br />

2836 Combudoron el WELEDA 24/08/05<br />

2837 Combudoron Mas´ć WELEDA 24/08/05<br />

2838 Combudoron Płyn do leczenia<br />

oparze<br />

WELEDA 24/08/05<br />

2839 Comdiuren Indapamidum Film-coated tablets 2,5 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08


EN<br />

884 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2840 Comdiuren Indapamidum Film-coated tablets 1,5 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

2841 Comfrey Gel — Z˙el<br />

z˙ywokostowy<br />

31/12/08<br />

Preparat złoz˙ony Gel for external use 80 mg/g Alpine Herbs Produkte AG 30/04/04<br />

2842 Compleven Kit: 2 solutions and<br />

emulsion for<br />

intravenous infusion<br />

Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

25/05/05<br />

2843 Comtan Entacaponum Film-coated tablets 200 mg Novartis Pharma AG 31/07/04<br />

2844 Concerta Methylphemidatum Prolonged release<br />

tablets<br />

2845 Concerta Methylphemidatum Prolonged release<br />

tablets<br />

2846 Concerta Methylphemidatum Prolonged release<br />

tablets<br />

18 mg Janssen — Cilag N.V. 31/12/08<br />

36 mg Janssen — Cilag N.V. 31/12/08<br />

54 mg Janssen — Cilag N.V. 31/12/08<br />

2847 CONCHAE comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

2848 CONCHAE comp. gran. WALA-Heilmittel GmbH 19/03/05<br />

2849 Conco Preparat złoz˙ony Gelatin capsules, soft Sunrider Manufacturing L.P.,<br />

USA<br />

31/12/08<br />

2850 Concor 5 Bisoprololum Film-coated tablets 5 mg Merck KGaA 16/11/05<br />

2851 Concor 10 Bisoprololum Film-coated tablets 10 mg Merck KGaA 16/11/05<br />

2852 CONCOR 10 Plus Bisoprololum +<br />

Hydrochlorothiazidum<br />

2853 CONCOR 5 Plus Bisoprololum +<br />

Hydrochlorothiazidum<br />

Film-coated tablets 10 mg +<br />

25 mg<br />

Film-coated tablets 5 mg +<br />

12,5 mg<br />

Merck KGaA 31/12/08<br />

Merck KGaA 31/12/08<br />

2854 Concor Cor 1,25 Bisoprololum Film-coated tablets 1.25 mg Merck KGaA 12/10/05<br />

2855 Concor Cor 10 Bisoprololum Film-coated tablets 10 mg Merck KGaA 12/10/05<br />

2856 Concor Cor 2,5 Bisoprololum Film-coated tablets 2.5 mg Merck KGaA 12/10/05<br />

2857 Concor Cor 3,75 Bisoprololum Film-coated tablets 3.75 mg Merck KGaA 12/10/05<br />

2858 Concor Cor 5 Bisoprololum Film-coated tablets 5 mg Merck KGaA 12/10/05<br />

2859 Concor Cor 7,5 Bisoprololum Film-coated tablets 7.5 mg Merck KGaA 12/10/05<br />

2861 Condral Chondroitini natrii sulfas Capsules 400 mg SPA Societa Prodotti<br />

Antibiotici SpA<br />

2860 Condral Chondroitini natrii sulfas Granules for oral<br />

solution<br />

2862 Condrosulf Sól sodowa siarczanu<br />

chondraityny<br />

2863 Condrosulf Sól sodowa siarczanu<br />

chondraityny<br />

Granules for oral<br />

solution<br />

2864 Condyline Podophyllotoxinum Solution for external<br />

use<br />

200 mg/g SPA Societa Prodotti<br />

Antibiotici SpA<br />

800 mg IBSA Institut Biochemique<br />

S.A.<br />

Tablets 800 mg IBSA Institut Biochemique<br />

S.A.<br />

30/06/04<br />

30/06/04<br />

31/12/08<br />

31/12/08<br />

5 mg/ml Yamanouchi Europe B.V. 31/07/04<br />

2865 Conium complexe nr 36 Drops Lehning Laboratoires 31/03/06<br />

2866 Conium similiaplex krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

30/11/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 885<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2867 Contac 400 Chlorpheniraminum +<br />

Phenylpropanolaminum<br />

2868 Contra infect c tablets Echinaceae purpureae<br />

extract.<br />

2869 Contra infect drops Echinaceae purpureae<br />

extract.<br />

Modified release<br />

capsules<br />

4mg + 50mg SmithKline Beecham<br />

Consumer Healthcare<br />

30/06/04<br />

Tablets Dr Rentschler Arzneimittel 31/12/08<br />

Drops Dr Rentschler Arzneimittel 31/12/08<br />

2870 Contractubex Gel Merz & Co. GmbH 31/12/04<br />

2871 Contrangin Rapid Cetylpirydinum<br />

chloridum + Lidocainum<br />

2872 Contril Dextromethorphanum +<br />

Guaifenesinum<br />

2873 Contril Guaifenesinum +<br />

Dextromethrphanium<br />

2874 Contril Junior Guaifenesinum +<br />

Dextromethrphani<br />

hydrobromidum<br />

Doetsch Grether AG 31/12/08<br />

Syrup US Pharmacia International<br />

Inc.<br />

Capsules, soft 100 mg +<br />

10 mg<br />

Syrup (50 mg + 5 mg )/<br />

5ml<br />

2875 Controloc Pantoprazolum Powder for solution<br />

for intravascular<br />

injection<br />

21/06/06<br />

US Pharmacia 31/12/08<br />

US Pharmacia 31/12/08<br />

40 mg Altana Pharma AG 29/06/05<br />

2876 Controloc 20 Pantoprazolum Tablets 20 mg Altana Pharma AG 31/03/05<br />

2877 Controloc 40 Pantoprazolum Film-coated tablets 40 mg Altana Pharma AG 26/11/06<br />

2878 Convafort Coated tablets 15.7 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/08/05<br />

2879 Convulex Acidum valproicum Capsules 500 mg Gerot Pharmazeutika GmbH 30/04/04<br />

2880 Convulex Acidum valproicum Syrup 50 mg/ml Gerot Pharmazeutika GmbH 30/04/04<br />

2881 Convulex 150 Acidum valproicum Capsules 150 mg Gerot Pharmazeutika GmbH 31/07/04<br />

2882 Convulex 300 Acidum valproicum Capsules 300 mg Gerot Pharmazeutika GmbH 31/07/04<br />

2883 Coopertix Pour On Cyhalotryna Solution for veterinary<br />

use<br />

Schering-Plough Central East 30/06/04<br />

2887 Coordinax Cisapridum Effervescent tablets 10 mg Janssen Pharmaceutica N.V. 12/10/05<br />

2888 Coordinax Cisapridum Oral suspension 1 mg/1ml Janssen Pharmaceutica N.V. 31/12/08<br />

2889 Coordinax Cisapridum Oral suspension 1 mg/ml Janssen Pharmaceutica N.V. 31/07/04<br />

2890 Coordinax Cisapridum Oral suspension 1mg/ml Janssen Pharmaceutica N.V. 31/12/08<br />

2884 Coordinax Cisapridum Tablets 10 mg Janssen Pharmaceutica N.V. 31/03/04<br />

2885 Coordinax Cisapridum Tablets 20 mg Janssen Pharmaceutica N.V. 12/10/05<br />

2886 Coordinax Cisapridum Tablets 5 mg Janssen Pharmaceutica N.V. 31/07/04<br />

2891 Copaxone Glatirameri acetas Powder and solvent<br />

for solution for<br />

subcutaneous<br />

injection<br />

20 mg Teva pharmaceuticals Ind.<br />

Ltd.<br />

2892 Copegus Ribavirinum Film-coated tablets 200 mg F. Hoffmann — La Roche<br />

Ltd.<br />

31/05/05<br />

31/12/08<br />

2893 Cophin 250 Ciprofloxacinum Film-coated tablets 250 mg Slovakofarma a.s. 31/12/08<br />

2894 Cor compositum N Amp. Heel GmbH 31/12/07


EN<br />

886 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2895 Corangin Isosorbidi mononitras Prolonged release<br />

tablets<br />

2896 Corangin Isosorbidi mononitras Prolonged release<br />

tablets<br />

40 mg Novartis Pharma AG 31/03/07<br />

60 mg Novartis Pharma AG 31/03/07<br />

2898 Cordafen Nifedipinum Film-coated tablets 10 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

2897 Cordafen Nifedipinum Oral drops 20 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

2899 Cordaflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

30/10/05<br />

30/10/05<br />

30/04/05<br />

2900 Cordarone Amiodaronum Solution for injection 50 mg/ml Sanofi Winthrop-Gentilly 30/06/04<br />

2901 Cordarone Amiodaronum Tablets 200 mg Sanofi Winthrop-Gentilly 30/06/04<br />

2902 Cordipin Nifedipinum Film-coated tablets 10 mg Krka d.d., Novo mesto 31/07/04<br />

2903 Cordipin retard Nifedipinum Prolonged release<br />

tablets<br />

20 mg Krka d.d., Novo mesto 31/07/04<br />

2904 Corectin 10 Bisoprololum Film-coated tablets 10 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

2905 Corectin 5 Bisoprololum Film-coated tablets 5 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

2906 Coreductal MR Trimetazidinum Modified release<br />

tablets<br />

35 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

2907 Coretal Oxprenololum Tablets 20 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

2908 Corifelin Szczepionka przeciw<br />

herpeswirusowym i<br />

kaliciwirusowym<br />

zakaz˙eniom górnych<br />

dróg oddechowych<br />

kotów<br />

Suspension for veterinary<br />

use<br />

31/12/08<br />

30/10/05<br />

Merial 21/05/04<br />

2909 Corinfar Nifedipinum Coated tablets 10 mg AWD.pharma GmbH & Co.<br />

KG<br />

2910 Corinfar Retard Nifedipinum Prolonged release<br />

coated tablets<br />

20 mg AWD.pharma GmbH & Co.<br />

KG<br />

31/07/04<br />

31/12/04<br />

2911 Corn Acidum salicylicum Pach 400 mg/g SSL International plc 30/01/05<br />

2912 Corn (Washproof) Acidum salicylicum Pach 400 mg/g SSL International plc 30/01/05<br />

2913 Corn and Callous Acidum salicylicum Coutanous liquid 125 mg/g SSL International plc 30/01/05<br />

2914 Corneregel Dexpanthenolum Eye gel 50 mg/g Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

2915 Corona Szczepionka dla psów<br />

przeciw zakaz˙eniom<br />

koronawirusowym<br />

Suspension for veterinary<br />

use<br />

2916 Corotrope Milrinonum Solution for<br />

intravenous injection<br />

21/02/06<br />

Intervet International 28/05/06<br />

1 mg/ml Sanofi Winthrop-Gentilly 31/01/05<br />

2917 Corpril Ramiprilum Capsules 1,25 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

2918 Corpril Ramiprilum Capsules 2,5 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

2919 Corpril Ramiprilum Capsules 5 mg Ranbaxy Laboratoires Ltd. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 887<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2920 Cortineff Fludrocortisonum Tablets 100 mcg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

2921 Cortineff ophtam 0,1 % Fludrocortisonum Eye ointment 1 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2922 Corvaton Molsidominum Solution for injection 2 mg/1 ml Hoechst Marion Roussel<br />

Deutschland GmbH<br />

2923 Corvaton Molsidominum Tablets 2 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

31/12/05<br />

30/11/05<br />

30/06/04<br />

30/06/04<br />

2924 Coryol Carvedilolum Tablets 12.5 mg Krka d.d., Novo mesto 15/03/06<br />

2925 Coryol Carvedilolum Tablets 25 mg Krka d.d., Novo mesto 15/03/06<br />

2926 Coryol Carvedilolum Tablets 6,5 mg KRKA d.d., Novo mesto 31/12/08<br />

2927 Coryol Carvedilolum Tablets 6,25 mg KRKA Polska Sp. z o.o. 31/12/08<br />

2928 Coryol Carvedilolum Tablets 12,5 mg KRKA Polska Sp. z o.o. 31/12/08<br />

2929 Coryol Carvedilolum Tablets 25 mg KRKA Polska Sp. z o.o. 31/12/08<br />

2930 Coryzalia Film-coated tablets Laboratoires BOIRON 31/12/07<br />

2931 Cosmofer Ferri hydroxidum et<br />

dextranum<br />

2932 Cosopt Dorzolamidum +<br />

Timololum<br />

2933 Cosumix Plus 12 % Sulfachloropirydazyna<br />

sodowa , Trimetoprim<br />

2934 Coverex Perindoprilum<br />

erbuminum<br />

Solution for injection<br />

or infusion<br />

50 mg Fe3+/ml Nebo A/S 31/12/08<br />

Eye drops 20mg + 5mg Merck Sharp & Dohme Idea<br />

Inc.<br />

Powder for veterinary<br />

use<br />

31/10/04<br />

Novartis Animal Health Inc. 6/03/05<br />

Tablets 4 mg Egis Pharmaceuticals Ltd. 27/04/05<br />

2935 Coxalgan Nabumetonum Film-coated tablets 500 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

2936 Coxeton Nabumetonum Film-coated tablets 500 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

2937 Coxidin 20 % Monenzyna Premix for veterinary<br />

use<br />

26/06/07<br />

31/12/08<br />

Biovet Join Company 31/12/08<br />

2939 Coxin 12,5 Rofecoxibum Oral suspension 12,5 mg / 5 ml Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

2938 Coxin 12,5 Rofecoxibum Tablets 12,5 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

2941 Coxin 25 Rofecoxibum Oral suspension 25 mg / 5 ml Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

2940 Coxin 25 Rofecoxibum Tablets 25 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

2942 Coxistac 12 % Salinomycyna Premix for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Pfizer Animal Health 31/12/08<br />

2943 Cozaar Losartanum Film-coated tablets 50 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

2944 Cozaar Losartanum Film-coated tablets 100 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

2945 Cozar Losartanum Film-coated tablets 12,5 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

8/07/06<br />

8/07/06<br />

31/12/08


EN<br />

888 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2946 Cralonin Amp. Heel GmbH 31/12/07<br />

2947 Cralonin Drops Heel GmbH 31/12/07<br />

2948 Crataegus complexe nr 15 Drops Lehning Laboratoires 31/03/06<br />

2949 CRATAEGUS/COR comp.<br />

ampułki<br />

2950 CRATAEGUS/COR comp.<br />

granulki<br />

2951 Crataegus-Dagomed 4 układ<br />

kra˛z˙enia<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

2952 Crataegus-Heel S Drops Heel GmbH 31/07/05<br />

2953 Cratecor Tablets Planta-Lek, Wrocław 31/12/08<br />

2954 Cratesol Crataegi extractum<br />

fluidum<br />

2955 Cratifar Crataegi inflorescentiae<br />

extractum siccum<br />

2956 Cratifar — plus Crataegi inflorescentiae<br />

extr.sicc + Ginkgo<br />

bilobae fol. extr. sicc.<br />

Liquid Phytopharm Kle˛ka S.A. 31/12/08<br />

Film-coated tablets 135 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

Film-coated tablets 95 mg +<br />

20 mg<br />

P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

2957 Cratinex Drops Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

2958 Cratonic Ctrataegi inflorescentiae<br />

extractum spissum<br />

Film-coated tablets 124.8 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/12/08<br />

14/03/07<br />

2959 Cravisol Preparat ziołowy Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

2960 Cresophene Dexamethasonum +<br />

Thymolum<br />

Liquid (1,11mg +<br />

50mg)/g<br />

2961 Crestar Norgestomed Implant + solution for<br />

injection<br />

for veterinary<br />

use<br />

Septodont 30/04/04<br />

Intervet 31/12/08<br />

2962 Crixan (Clabax) Clarithromycinum Film-coated tablets 500 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

2963 Crixan (Clabax) Clarithromycinum Film-coated tablets 250 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

2964 Crixivan Indinavirum Capsuels, hard 100 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

2965 Crixivan 200 Indinavirum Capsules 200 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

2966 Crixivan 333 Indinavirum Capsuels, hard 333 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

2967 Crixivan 400 Indinavirum Capsules 400 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

2968 Cromogen EB Acidum cromoglicicum Pressurised inhalation,<br />

suspension<br />

2969 Cromogen Inhaler Acidum cromoglicicum Pressurised inhalation,<br />

suspension<br />

9/08/06<br />

31/12/07<br />

31/05/05<br />

31/12/07<br />

5 mg/dawke˛ Norton Healthcare Ltd. 30/06/04<br />

5 mg/dawke˛ Norton Healthcare Ltd. 30/06/04<br />

2971 Cromohexal Acidum cromoglicicum Eye drops, solution 20 mg/ml Hexal AG 31/05/05<br />

2972 Cromohexal Acidum cromoglicicum Inhalation solution 10 mg/ml Hexal AG 14/11/05<br />

2970 Cromohexal Acidum cromoglicicum Nasal spray 2.8 mg/dawke˛<br />

donosowa˛<br />

Hexal AG 30/04/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 889<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2973 Cromohexal® Eko Natrii cromoglicas Nasal spray, solution 20 mg/ml HEXAL AG 31/12/08<br />

2974 Cromolyn Acidum cromoglicicum Inhalation powder,<br />

capsules<br />

20 mg Orion Corporation 30/06/04<br />

2978 Cromosol Acidum cromoglicicum Eye drops 2 % (0,02 g/ml) ICN Polfa Rzeszów S.A. 31/05/06<br />

2975 Cromosol Acidum cromoglicicum Gargle spray 40 mg/ml ICN Polfa Rzeszów S.A. 4/12/06<br />

2976 Cromosol Acidum cromoglicicum Nasal spray 40 mg/ml ICN Polfa Rzeszów S.A. 4/10/06<br />

2977 Cromosol Acidum cromoglicicum Nasal spray, solution 2.6 mg/dawke˛<br />

donosowa˛<br />

2979 Cropoz Acidum cromoglicicum Inhalator areosol,<br />

suspension<br />

2980 Cropoz G Acidum cromoglicicum Powder for oral<br />

solution<br />

5 mg/dawke˛<br />

inhalacyjna˛<br />

ICN Polfa Rzeszów S.A. 30/04/05<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

100 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2981 Cropoz N Acidum cromoglicicum Nasal spray 2.8 mg/dawke˛ GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2982 Cropoz Plus Acidum cromoglicicum Inhalator areosol,<br />

suspension<br />

5 mg/dawke˛<br />

inhalacyjna˛<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2983 Crotamiton Crotamitonum Ointment 100 mg/g Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

2984 Crotamiton 10 % Crotamitonum Coutanous liquid 100 mg/g Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

30/04/05<br />

31/12/08<br />

31/12/08<br />

30/04/05<br />

31/01/06<br />

31/01/06<br />

2985 CRP Film-coated tablets Puritan's Pride, Incorporated 31/12/08<br />

2986 Crupodex Dextranomerum Medicated powder Biogal Pharmaceutical Works<br />

Ltd.<br />

30/11/04<br />

2987 Cruroheel S Tablets Heel GmbH 31/12/07<br />

2988 Cryomarex Rispens Szczepionka przeciw<br />

chorobie Mareka<br />

2989 Cryomarex Rispens + HVT Szczepionka przeciw<br />

chorobie Mareka<br />

2990 Cryomarex-HVT Szczepionka przeciw<br />

chorobie Mareka dla<br />

kurcza˛t<br />

Suspension + solvent for veterinary<br />

use<br />

Suspension + solvent for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

2991 CTC Spray Chlortetracyclinum Suspension, spray for veterinary<br />

use<br />

2992 Cunipastivac E Szczepionka dla<br />

królików przeciw<br />

pasterelozie<br />

2993 Cunivac Szczepionka przeciw<br />

pomorowi królików<br />

Oil emulsion for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Merial SAS 31/12/08<br />

Merial SAS 31/12/08<br />

Merial SAS 24/08/04<br />

Eurovet Animal Health 20/04/06<br />

Biowet Puławy Sp. z o.o. 15/01/06<br />

Państwowy Instytut<br />

Weterynaryjny , Zakład<br />

Pryszczycy<br />

2994 Cuprenil Penicillaminum Film-coated tablets 250 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/05<br />

2995 Cuprofen Ibuprofenum Film-coated tablets 200 mg Seton Scholl Healtcare 31/12/08<br />

2996 Cuprofen Ibuprofenum Film-coated tablets 400 mg Seton Scholl Healtcare 31/12/08<br />

2997 CUPRUM ACETICUM comp.<br />

amp.<br />

WALA-Heilmittel GmbH 19/03/05


EN<br />

890 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

2998 Cuprum-Dagomed 23 astma DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

3001 Curam Acidum clavulanicum +<br />

Amoxicillinum<br />

3002 Curam Acidum clavulanicum +<br />

Amoxicillinum<br />

2999 Curam Acidum clavulanicum +<br />

Amoxicillinum<br />

3000 Curam Acidum clavulanicum +<br />

Amoxicillinum<br />

3003 Curam Amoxicillinum +<br />

Acidum clavulanicum<br />

31/01/06<br />

Film-coated tablets 625 mg Biochemie GmbH Kundl 30/09/05<br />

Film-coated tablets 125 mg +<br />

250mg<br />

Powder for oral<br />

suspension<br />

Powder for oral<br />

suspension<br />

156.25 mg/<br />

5ml<br />

Film-coated tablets 875 mg +<br />

125 mg<br />

Biochemie GmbH — Kundl 30/09/05<br />

Biochemie GmbH Kundl 30/11/04<br />

312.5 mg/5ml Biochemie GmbH Kundl 30/11/04<br />

Biochemie GmbH 31/12/08<br />

3004 Curantyl N 75 Dipyridamolum Film-coated tablets 75 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

3005 Curatoderm Tacalcitolum Cutaneous emulsion 4,17 µg/g Boots Healthcare<br />

International<br />

3006 Curatoderm Tacalcitolum Ointment 4.17 mcg/g Boots Healthcare<br />

International<br />

3007 Curbicin Sabalis serrulatae fructus<br />

extr., Cucurbitae peponis<br />

extr.<br />

3008 Curosurf Surfactantum Endotracheopulmonary<br />

and<br />

bronchi instilation,<br />

suspension<br />

3009 Curosurf Surfactantum Endotracheopulmonary<br />

and<br />

bronchi instilation,<br />

suspension<br />

Tablets 80mg + 80 mg Pharbio Medical Sverige AB,<br />

Sweden<br />

30/06/04<br />

31/12/08<br />

31/12/07<br />

31/12/08<br />

120 mg/1,5 ml Chiesi Farmaceutici S.p.A. 31/12/08<br />

240 mg/3 ml Chiesi Farmaceutici S.p.A. 31/12/08<br />

3010 Cusicrom 4 % Acidum cromoglicicum Eye drops 40 mg/ml Alcon Cusi, S.A. 31/12/05<br />

3011 Cusimolol 0,25 % Timololum Eye drops 2.5 mg/ml Alcon Cusi, S.A. 30/06/04<br />

3012 Cusimolol 0,5 % Timololum Eye drops 5 mg/ml Alcon Cusi, S.A. 30/06/04<br />

3013 Cusiviral Aciclovirum Eye ointment 30 mg/g Alcon Cusi, S.A. 30/06/04<br />

3014 Cutis compositum Amp. Heel GmbH 31/12/07<br />

3015 Cutivate Fluticasonum Cream 0.5 mg/g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

3016 Cutivate Fluticasonum Ointment 0.05 mg/g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

3017 CYCLAMEN Pentarkan /Ptk<br />

nr 39/<br />

DHU-Arzneimittel GmbH &<br />

Co.KG<br />

28/06/05<br />

28/06/05<br />

5/02/05<br />

3018 Cyclo 3 Fort Capsuels, hard 150 mg Pierre Fabre Medicament 10/05/06<br />

3019 Cyclo-Menorette Estradiolum + Estriolum<br />

+ Levonorgestrelum<br />

Coated tablets białe: 1 mg<br />

estradiolu i<br />

2 mg estriolu;<br />

róz˙owe: 1 mg<br />

estradiolu,<br />

2 mg estriolu i<br />

0,25 mg<br />

levonorgestrelu.<br />

Wyeth Pharma GmbH 30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 891<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3020 Cyclonamine Etamsylatum Tablets 250 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

3021 Cyclonamine 12,5 % Etamsylatum Solution for injection 125 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

3022 Cycloplatin 150 Carboplatinum Solution for<br />

intravenous infusion<br />

3023 Cycloplatin 200 Carboplatinum Powder for solution<br />

for injection<br />

3024 Cycloplatin 450 Carboplatinum Solution for<br />

intravenous infusion<br />

3025 Cycloplatin 50 Carboplatinum Powder for solution<br />

for injection<br />

3026 Cycloplatin 50 Carboplatinum Solution for<br />

intravenous infusion<br />

3027 Cyclo-Premella 5 Estrogena coniugata +<br />

Medroxyprogesteronum<br />

3028 Cyclo-Progynova Estradiolum +<br />

Norgestrelum<br />

Film-coated with<br />

sugar tablets<br />

3029 Cycostat 66 Robenidyna Granules for veterinary<br />

use<br />

3030 Cydectin 1 % Moksydektyna Solution for veterinary<br />

use<br />

3031 Cyflee Cytioat Tablet for veterinary<br />

use<br />

3032 Cygro 1 % Maduramycyna<br />

sodowa<br />

30/10/05<br />

30/10/05<br />

150 mg PLIVA — LACHEMA a.s. 31/03/05<br />

200 mg PLIVA — LACHEMA a.s. 31/05/04<br />

10 mg/ml PLIVA — LACHEMA a.s. 31/03/05<br />

50 mg PLIVA — LACHEMA a.s. 31/05/04<br />

10 mg/ml PLIVA — LACHEMA a.s. 31/03/05<br />

Wyeth-Lederle Pharma GmbH 14/12/05<br />

Film-coated tablets Schering AG 30/11/04<br />

Granules for veterinary<br />

use<br />

3033 Cyklosporyna Ciclosporinum Capsules 10 mg, 25 mg,<br />

50 mg, 100 mg<br />

Alpharma AS 11/03/04<br />

Fort Dodge-Animal Health 19/10/06<br />

Fort Dodge-Animal Health 27/04/04<br />

Fort Dodge-Animal Health 20/05/04<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

3034 Cymevene Ganciclovirum Capsules 250 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

3035 Cymevene Ganciclovirum Powder for solution<br />

for intravenous<br />

injection<br />

500 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

31/12/08<br />

31/12/08<br />

31/07/04<br />

3036 Cynachol Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

3037 Cynacholin Cynarae herbae<br />

extractum fluidum<br />

3038 Cynacur Cynarae folium<br />

extractum sicc.<br />

3039 Cynamus Cynara scolymus extr.<br />

Siccum<br />

3040 Cynara 400 Cynarae folium<br />

extractum siccum<br />

Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

Film-coated tablets 300 mg Biocur Arzneimittel GmbH 31/12/08<br />

Film-coated tablet 300 mg US Pharmacia 31/12/08<br />

Capsules, hard 400 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

3041 Cynarein Coated tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

3042 Cynarex Tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/08/05<br />

31/08/05<br />

3043 Cynku siarczan Pharma Cosmetic, Kraków 24/08/06


EN<br />

892 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3044 Cynku siarczan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

3045 Cynku tlenek BUFA b.v. Pharmaceutical<br />

Products<br />

24/08/06<br />

14/01/05<br />

3046 Cynku tlenek Chema Elektromet, Rzeszów 14/01/05<br />

3047 Cynku tlenek Pharma Cosmetic, Kraków 14/01/05<br />

3048 Cynku tlenek Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

3049 Cynku tlenek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

3050 Cynku tlenek Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

3051 Cyprofina Cyproterini acetas +<br />

Ethinyloestradiolum<br />

Film-coated tablets 2 mg +35<br />

mikrogramów<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

14/01/05<br />

14/01/05<br />

14/01/05<br />

31/12/08<br />

3052 Cyrkulavit Bional Pharma BV 31/12/08<br />

3053 Cystrin Oxybutyninum Tablets 3 mg Sanofi — Synthelabo 31/12/06<br />

3054 Cytarabin Cytarabinum Lyophilisate for<br />

solution for injection<br />

100 mg Grindeks — Public Joint<br />

Stock Company<br />

3055 Cytarabine Cytarabinum Solution for injection 100 mg/ml Pharmacia Upjohn Pty Ltd.<br />

Bentley<br />

3056 Cytarabine Cytarabinum Solution for injection 20 mg/ml Pharmacia Upjohn Pty Ltd.<br />

Bentley<br />

3057 Cytarabine Therabel Cytharabinum Solution 100 mg/5 ml Therabel Pharma<br />

(Laboratories Thisen)<br />

3058 CytoGam Cytomegalovirus<br />

immunoglobulin<br />

3061 Cytosar Cytarabinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

3060 Cytosar Cytarabinum Lyophilisate and<br />

solvent for solution<br />

for subcutaneous and<br />

intravascular injection<br />

3059 Cytosar Cytarabinum Lyophilisate for<br />

solution for<br />

subcutaneous and<br />

intravascular injection<br />

30/01/05<br />

26/04/06<br />

26/04/06<br />

31/12/08<br />

Intravenous injection 50 mg/ml Massachusetts Public Health 31/12/08<br />

100 mg Pharmacia N.V./S.A. 30/06/04<br />

0.5 g Pharmacia N.V./S.A. 31/12/08<br />

1 g Pharmacia N.V./S.A. 30/01/05<br />

3062 Cytotec Misoprostolum Tablets 200 mcg Searle Division of Monsanto<br />

plc.<br />

3063 Cytotect Immunoglobulinum<br />

humanum<br />

Solution for<br />

intravenous infusion<br />

3064 Cytoxan Cyclophosphamidum Lyophilisate for<br />

injection<br />

3065 Cytribin Trikalium<br />

dicitratobismuthatum<br />

Film-coated tablets 120 mg (w<br />

przeliczeniu na<br />

tlenek<br />

bizmutawy)<br />

31/07/04<br />

50 j.m./ml Biotest Pharma GmbH 31/03/04<br />

2,0 g Bristol — Myers Squibb 31/12/08<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/10/05<br />

3066 Czerwona mas´ć miedziana Ointment WALA-Heilmittel GmbH 24/05/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 893<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3067 Czerwony siarczek rte˛ciowy Pharma Cosmetic, Kraków 31/12/08<br />

3068 Czopki glicerolowe Suppository 1 g Aflofarm Farmacja Polska,<br />

Pabianice<br />

3069 Czopki glicerolowe Suppository 2 g Aflofarm Farmacja Polska,<br />

Pabianice<br />

24/08/05<br />

24/08/05<br />

3070 Czopki glicerolowe Apipol-Farma, Mys´lenice 24/08/05<br />

3071 Czopki glicerolowe Avena, Bydgoszcz 24/08/05<br />

3072 Czopki glicerolowe Bartpol, Poznań 24/08/05<br />

3073 Czopki glicerolowe Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o., Lublin<br />

24/08/05<br />

3074 Czopki glicerolowe Cefarm Gdańsk 24/08/05<br />

3075 Czopki glicerolowe Cefarm Szczecin 24/08/05<br />

3076 Czopki glicerolowe Elissa, Warszawa 24/08/05<br />

3077 Czopki glicerolowe Farimex, Warszawa 24/08/05<br />

3078 Czopki glicerolowe Farmina Sp. z o.o., Kraków 24/08/05<br />

3079 Czopki glicerolowe Farmjug, Kartuzy 24/08/05<br />

3080 Czopki glicerolowe Hasco-Lek, Wrocław 24/08/05<br />

3081 Czopki glicerolowe ICN Polfa Rzeszów 24/08/05<br />

3082 Czopki glicerolowe Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

24/08/05<br />

3083 Czopki glicerolowe Lefarm, Bydgoszcz 24/08/05<br />

3084 Czopki glicerolowe Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

24/08/05<br />

3085 Czopki glicerolowe PPF GEMI, Karczew 24/08/05<br />

3086 Czopki glicerolowe PZF ‘Cefarm-Lublin’ S.A. 24/08/05<br />

3087 Czopki Glicerynowe Glycerolum Suppository 0.7 g Farmjug Sp. z o.o. 31/01/06<br />

3088 Czopki Glicerynowe Glycerolum Suppository 1.4 g Farmjug Sp. z o.o. 31/01/06<br />

3089 Czopki przeciw hemoroidom Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/07<br />

3090 Czopki przeciw hemoroidom Bartpol, Poznań 31/12/07<br />

3091 Czopki przeciw hemoroidom Cefarm Gdańsk 31/12/07<br />

3092 Czopki przeciw hemoroidom Hasco-Lek, Wrocław 31/12/07<br />

3093 Czopki przeciw hemoroidom<br />

(BIOHEMORIL)<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o., Lublin<br />

24/01/05<br />

3094 Czopki przeciwskurczowe Farmina Sp. z o.o., Kraków 30/09/05<br />

3095 Czopki przeciwskurczowe<br />

SPAZMOGEN<br />

PPF GEMI, Karczew 31/12/08


EN<br />

894 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3096 Czosnek Allii sativi bulbus pulv. Film-coated tablets 150 mg ELANDA Zakład Prod.<br />

S´ rodków<br />

Farmaceutycznych,B. Kazub,<br />

A. Orłowski, Spółka<br />

jawna,Rozprza<br />

3097 Czpoki przeciwskurczowe<br />

(BIOSPASMIL)<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o., Lublin<br />

31/12/08<br />

30/06/06<br />

3098 Czteroboran sodowy Hasco-Lek, Wrocław 31/05/05<br />

3099 Czynnik VIII (Metoda M) 1000 Coagulation factor VIII Lyophilisate for<br />

solution for<br />

intravenous injection<br />

3100 Czynnik VIII (Metoda M) 250 Coagulation factor VIII Lyophilisate for<br />

solution for<br />

intravenous injection<br />

3101 Czynnik VIII (Metoda M) 500 Coagulation factor VIII Lyophilisate for<br />

solution for<br />

intravenous injection<br />

3102 D.T.COQ Diphtheria-tetanuspertussis<br />

3103 D.T.COQ Diphtheria-tetanuspertussis<br />

Suspension for<br />

intramuscular<br />

injection<br />

Suspension for<br />

intramuscular<br />

injection<br />

3104 Dacarbazin 100 Dacarbazinum Powder for solution<br />

for injection and<br />

intravenous infusion<br />

3105 Dacarbazin 200 Dacarbazinum Powder for solution<br />

for injection and<br />

intravenous infusion<br />

1000 j.m. ZLB Bioplasma AG 30/06/04<br />

250 j.m. ZLB Bioplasma AG 30/06/04<br />

500 j.m. ZLB Bioplasma AG 30/06/04<br />

0.5 ml (1<br />

dawka)<br />

5 ml (10<br />

dawek)<br />

Aventis Pasteur S.A. 21/06/06<br />

Aventis Pasteur S.A. 21/06/06<br />

100 mg PLIVA — LACHEMA a.s. 31/01/05<br />

200 mg PLIVA — LACHEMA a.s. 31/01/05<br />

3106 Dacarbazine Dacarbazinum Laboratoires Thissen 31/12/08<br />

3107 Dacrolux Dextranum +<br />

Hypromellosum<br />

3108 Dafalgin codeine Codeinum +<br />

Paracetamolum<br />

Eye drops, solution Alcon Cusi, S.A. 30/06/04<br />

Film-coated tablets UPSA Laboratoires Agen 6/09/06<br />

3111 Dafnegin Ciclopiroxum Liquid for irrigation 2 mg/ml Poli Industria Chimica S.p.A 30/06/04<br />

3109 Dafnegin Ciclopiroxum Pessary 100 mg Poli Industria Chimica S.p.A 30/06/04<br />

3110 Dafnegin Ciclopiroxum Vaginal cream 10 mg/g Poli Industria Chimica S.p.A 30/06/04<br />

3112 Daivobet® Calcipotriolum,<br />

Bethametasonum<br />

Ointment (50 µg +<br />

0,5 mg)/g<br />

Leo Pharmaceutical Products<br />

Ltd.<br />

31/12/08<br />

3115 Daivonex Calcipotriolum Coutanous liquid 50 mcg/ml Leo Pharmaceuticals Products 6/12/06<br />

3113 Daivonex Calcipotriolum Cream 50 mcg/g Leo Pharmaceuticals Products 6/12/06<br />

3114 Daivonex Calcipotriolum Ointment 50 mcg/g Leo Pharmaceuticals Products 31/03/07<br />

3116 Daktacort Hydrocortisonum +<br />

Miconazoli nitras<br />

Cream (10mg +<br />

20mg)/g<br />

Janssen Pharmaceutica N.V. 31/07/04<br />

3117 Daktarin Miconazoli nitras Cream 20 mg/g Janssen Pharmaceutica N.V. 30/06/04<br />

3118 Daktarin Miconazoli nitras Cream 20 mg/g ICN Polfa Rzeszów S.A. 31/01/06<br />

3120 Daktarin Miconazoli nitras Cutaneous powder<br />

spray<br />

20 mg/g Janssen-Cilag N.V. 12/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 895<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3119 Daktarin Miconazoli nitras Medicated powder 20 mg/g Janssen Pharmaceutica N.V. 31/12/08<br />

3121 Daktarin Miconazolum Oromucosal gel 20 mg/g Janssen Pharmaceutica N.V. 31/12/06<br />

3122 Dalacin Clindamycinum Pessary 100 mg Pharmacia & Upjohn Co. 12/10/05<br />

3123 Dalacin Clindamycinum Vaginal cream 20 mg/g Pharmacia & Upjohn Co. 30/06/07<br />

3125 Dalacin C Clindamycinum Capsules 150 mg Pharmacia N.V./S.A. 30/04/04<br />

3126 Dalacin C Clindamycinum Capsules 300 mg Pharmacia N.V./S.A. 31/12/04<br />

3127 Dalacin C Clindamycinum Capsules 75 mg Pharmacia N.V./S.A. 30/04/04<br />

3124 Dalacin C Clindamycinum Granules for syrup 75 mg/5 ml Pharmacia N.V./S.A. 30/04/05<br />

3128 Dalacin C Clindamycinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

150 mg/ml Pharmacia N.V./S.A. 30/04/04<br />

3130 Dalacin T Clindamycinum Coutanous liquid 10 mg/ml Pharmacia N.V./S.A. 30/06/04<br />

3129 Dalacin T Clindamycinum Emulsion for external<br />

use<br />

10 mg/ml Pharmacia & Upjohn Ltd,<br />

Buckinghamshire<br />

30/09/04<br />

3131 Dalacin T Clindamycinum Gel 1 % Pharmacia & Upjohn Co. 31/12/08<br />

3132 Dalcipran 25 Milnacipranum Capsules 25 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

31/07/05<br />

3133 Dalcipran 50 Milnacipranum Capsules 50 mg Synthelabo Group.-Tours 31/07/05<br />

3134 Daleron Paracetamolum +<br />

Acidum ascorbicum<br />

Granules for oral<br />

solution<br />

500 mg +<br />

20 mg<br />

KRKA d.d., Novo mesto 31/12/08<br />

3135 Daleron Cold 3 Preparat złoz˙ony Film-coated tablets KRKA d.d., Novo mesto 31/12/08<br />

3136 DALERON Junior Paracetamolum +<br />

Acidum ascorbicum<br />

Granules for oral<br />

solution<br />

120 mg +<br />

10 mg<br />

KRKA d.d., Novo mesto 31/12/08<br />

3137 Dalfaz Alfuzosinum Film-coated tablets 2.5 mg Sanofi-Synthelabo France 27/09/06<br />

3138 Dalfaz SR5 Alfuzosinum Film-coated, slow<br />

release tablets<br />

3139 Dalfaz Uno Alfuzosinum Prolonged release<br />

tablets<br />

3140 Dalmazin Kloprostenol Solution for veterinary<br />

use<br />

3141 Dampiryna Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Paracetamolum<br />

5 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

10 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

31/03/04<br />

6/07/05<br />

Fatro Włochy 31/12/08<br />

Tablets Chance — Zakład Produkcji<br />

Chemiczno —<br />

Farmaceutycznej s.c.<br />

3142 Danazol Danazolum Tablets 200 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/12/08<br />

31/01/06<br />

3143 Danazol Danazolum Tablets 200 mg Polfarmex S.A. 14/02/07<br />

3144 Danoval Danazolum Capsules 100 mg Krka d.d., Novo mesto 31/07/04<br />

3145 Danoval Danazolum Capsules 200 mg Krka d.d., Novo mesto 31/07/04<br />

3146 Dantrolen Dantrolenum Powder and solvent<br />

for solution for<br />

injection<br />

20 mg Procter & Gamble<br />

Pharmaceuticals GmbH<br />

31/07/04<br />

3147 Dapril 10 Lisinoprilum Tablets 10 mg Medochemie Ltd. 31/12/08


EN<br />

896 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3148 Dapril 20 Lisinoprilum Tablets 20 mg Medochemie Ltd. 31/12/08<br />

3149 Dapril 5 Lisinoprilum Tablets 5 mg Medochemie Ltd. 31/12/08<br />

3150 Daraprim Pyrimethaminum Tablets 25 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

3151 Dardum Cefoperazonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1 g Lab. It. Biochim. Farm. Co.<br />

LISAPHARMA S.p.A.<br />

30/04/04<br />

30/06/05<br />

3153 Darob Sotalolum Film-coated tablets 160 mg Abbott GmbH & Co KG 27/09/06<br />

3154 Darob Sotalolum Film-coated tablets 80 mg Abbott GmbH & Co KG 27/09/06<br />

3152 Darob Sotalolum Solution for injection 40 mg/4 ml Abbott GmbH & Co KG 31/12/06<br />

3155 Dartelin retard Pentoxifyllinum Prolonged release<br />

tablets<br />

3156 Dartelin retard Pentoxifyllinum Prolonged release<br />

tablets<br />

400 mg Lek Pharmaceuticals d.d. 30/06/04<br />

400 mg Lek Polska Sp. z o.o. 31/12/05<br />

3157 Darvalidol Menthyli valeras Buccal tablet 60 mg Darnica S.A. 29/09/06<br />

3158 Datscan Preparat<br />

radiofarmaceutyczny<br />

3159 Daunorubicinum Daunorubicinum Lyophilisate for<br />

solution for injection<br />

and intravenous<br />

infusion<br />

Solution for injection 74 MBq/ML Amersham PLC Amersham<br />

Place<br />

20 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3161 Davercin Erythromycinum Coutanous liquid 25 mg/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3162 Davercin Erythromycinum Film-coated tablets 250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3163 Davercin Erythromycinum Gel 2.5 % Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3160 Davercin Erythromycinum Granules for oral<br />

solution<br />

3164 Debecylina Benzathini<br />

benzylpenicillinum<br />

3165 Debecylina Benzathini<br />

benzylpenicillinum<br />

3166 Debelizyna Dolichos biflori semen<br />

extractum<br />

Powder for<br />

suspension for<br />

intramuscular<br />

injection<br />

Powder for<br />

suspension for<br />

intramuscular<br />

injection<br />

Paste for oral<br />

suspension<br />

150 mg/5ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1.2e+006 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

600000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

3167 Debretin Trimebutini maleas Film-coated tablets 100 mg Medana Pharma Terpol<br />

Group S.A.<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

31/08/05<br />

14/02/07<br />

3169 Debridat Trimebutinum Film-coated tablets 100 mg Parke-Davis 7/06/05<br />

3168 Debridat Trimebutinum Granules for solution 7.87 mg/g Parke-Davis 11/07/06<br />

3170 Deca-Durabolin Nandroloni decanoas Solution for injection 50 mg/1 ml Organon N.V. 30/04/04<br />

3171 Decaldol Haloperidolum Solution for injection 50 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/10/05<br />

3172 DECAMEVIT — Multivitamin Preparat witaminowy KYIV VITAMIN FACTORY Co 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 897<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3173 Decan Preparat złoz˙ony Concentrate for<br />

solution for infusion<br />

3174 Decapeptyl 0,1 mg Triptorelinum Solution for<br />

subcutanous injection<br />

3175 Decapeptyl 0,5 mg Triptorelinum Solution for<br />

subcutanous injection<br />

3176 Decapeptyl Depot Triptorelinum Microgranules and<br />

solvent for suspension<br />

for intramuscular<br />

injection<br />

3177 Decarbazine Therabel 100 Dacarbazinum Powder for solution<br />

for intravenous or<br />

intra-arterial infusion<br />

3178 Decarbazine Therabel 200 Dacarbazinum Powder for solution<br />

for intravenous or<br />

intra-arterial infusion<br />

3179 Decarbazinum Decarbazinum Powder for solution<br />

for injection and<br />

intravenous infusion<br />

Baxter Healthcare<br />

Corporation<br />

31/12/08<br />

0.1 mg/ml Ferring GmbH 6/06/07<br />

0.5 mg/ml Ferring GmbH 6/06/07<br />

3.75 mg Ferring GmbH 25/07/05<br />

100 mg Therabel Pharma S.A.<br />

(Therabel Group)<br />

200 mg Therabel Pharma S.A.<br />

(Therabel Group)<br />

100 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8/02/06<br />

8/02/06<br />

31/12/08<br />

3180 Decaris Levamisolum Tablets 150 mg Gedeon Richter Ltd. 31/07/04<br />

3181 Decomoton Karbetocyna Solution for veterinary<br />

use<br />

3182 Dectomax Doramektyna Solution for veterinary<br />

use<br />

3183 Decubitol Allantoinum + Zinci<br />

oxydum<br />

3184 Deep freeze Preparat złoz˙ony Cutaneous spray,<br />

solution<br />

Cutaneous spray (0,75mg +<br />

25mg)/g<br />

Laboratiorios Calier S.A. 29/03/07<br />

Pfizer 31/12/05<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

The Mentholatum Company<br />

Limited, U.K.<br />

3185 Deep Freeze Mentholum Gel 20 mg/g The Mentholatum Company<br />

Ltd.<br />

3187 Deep Heat Cream The Mentholatum Company<br />

Ltd.<br />

3186 Deep Heat Cutaneous spray The Mentholatum Company<br />

Ltd.<br />

3188 Deep Relief Ibuprofenum +<br />

Mentholum<br />

3189 Defensor 3 Szczepionka przeciw<br />

ws´ciekliz´nie dla psów,<br />

kotów, bydła i owiec<br />

Gel The Mentholatum Company<br />

Ltd.<br />

Liquid for veterinary<br />

use<br />

31/01/06<br />

31/12/08<br />

29/11/06<br />

31/05/04<br />

31/05/04<br />

30/09/04<br />

Pfizer 9/06/04<br />

3191 Deflegmin Ambroxolum Oral drops 7.5 mg/ml ICN Polfa Rzeszów S.A. 1/08/05<br />

3190 Deflegmin Ambroxolum Prolonged release<br />

capsules<br />

75 mg ICN Polfa Rzeszów S.A. 1/08/05<br />

3192 Deflegmin Ambroxolum Tablets 30 mg ICN Polfa Rzeszów S.A. 1/08/05<br />

3193 Degrosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

3194 Degrotex-fix Zioła pobudzaja˛ce<br />

trawienie<br />

Mieszanka ziołowa Instant herbal tea Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

3195 Degrovit Herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

31/08/05<br />

31/08/05


EN<br />

898 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3196 Degrovit Instant herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

3197 Dehalid Capsules, soft Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

31/03/07<br />

9/08/06<br />

3198 Deksametazon Pharma Cosmetic, Kraków 19/03/07<br />

3199 Dekstran 70 000 — 6 % Dextranum Solution for<br />

intravenous infusion<br />

3200 Dekstran 40 000 — 10 % Dextranum Solution for<br />

intravenous infusion<br />

60 mg/ml Fresenius Kabi Polska Sp. z<br />

o.o.<br />

100 mg/ml Fresenius Kabi Polska Sp. z<br />

o.o.<br />

30/01/05<br />

31/01/06<br />

3201 Dekstromet Dekstrometorphanum Drops Amilek Sp. z o.o. 31/12/08<br />

3202 Dekstromet Dekstrometorphanum Tablets Amilek Sp. z o.o. 31/12/08<br />

3203 Delacet Delphinii consolidae<br />

tinctura<br />

Coutanous liquid 834 mg/ml Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

31/08/05<br />

3204 Delatar Pix litanthracis Ointment 20 mg/g Lek Pharmaceuticals d.d. 31/07/04<br />

3205 Delfen Nonoxinolum-9 Cream 50 mg/g Cilag AG 30/06/04<br />

3206 Delinen Preparat złoz˙ony Cream Laboratorium Galenowe<br />

‘LEFARM’ Sp. z o.o.<br />

3207 Delinen A + D Preparat złoz˙ony Cream Laboratorium Galenowe<br />

‘LEFARM’ Sp. z o.o.<br />

3208 Delmuno 2,5 Ramiprilum +<br />

Felodipinum<br />

3209 Delmuno 5 Ramiprilum +<br />

Felodipinum<br />

Film-coated tablets 2,5 mg/2,5 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

Film-coated tablets 5 mg/5 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

31/12/04<br />

31/12/08<br />

30/09/07<br />

30/09/07<br />

3210 Delufen Drops Richard Bittner 9/09/07<br />

3211 Delvosteron Proligeston Suspension for veterinary<br />

use<br />

Intervet 31/12/08<br />

3212 Dentacin Oromucosal solution Montefarmaco S.p.A. Milano 30/11/04<br />

3213 Denticalm Ibuprofenum Film-coated tablets 200 mg Stada Arzneimittel AG 31/12/08<br />

3215 Dentinox N Chamomillae tinctura +<br />

Lidocainum<br />

3214 Dentinox N Chamomillae tinctura +<br />

Lidocainum<br />

Gingival gel Dentinox Gesellschaft fur<br />

pharmaceutische Praparate<br />

Lenk & Schuppan<br />

Gingival solution Dentinox Gesellschaft fur<br />

pharmaceutische Praparate<br />

Lenk & Schuppan<br />

31/05/04<br />

31/05/04<br />

3216 Dentispray Benzocainum Spray 50 mg/g Laboratorios Vinas sa 12/10/05<br />

3217 Dentosept Preparat ziołowy Oromucosal solution Phytopharm Kle˛ka S.A. 31/08/05<br />

3218 Dentosept A Preparat ziołowy Oromucosal solution Phytopharm Kle˛ka S.A. 31/08/05<br />

3221 Depakine Acidum valproicum Film-coated tablets 300 mg Sanofi Winthrop-Gentilly<br />

Cedex<br />

3219 Depakine Acidum valproicum Powder and solvent<br />

for solution for<br />

intravenous injection<br />

(400mg)<br />

400 mg/4ml<br />

30/06/04<br />

Sanofi Winthrop-Gentilly 30/06/07<br />

3220 Depakine Acidum valproicum Syrup 288.2 mg/5ml Sanofi-Synthelabo France 31/12/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 899<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3222 Depakine 200 Acidum valproicum Film-coated tablets 200 mg Sanofi Winthrop-Gentilly 30/04/04<br />

3223 Depakine 500 Acidum valproicum Film-coated tablets 500 mg Sanofi Winthrop-Gentilly 30/04/04<br />

3224 Depakine Chrono 300 Acidum valproicum Film-coated, prologed<br />

release tablets<br />

3225 Depakine Chrono 300 Acidum valproicum Prolonged release<br />

tablets<br />

3226 Depakine Chrono 500 Acidum valproicum Film-coated, slow<br />

release tablets<br />

3<strong>227</strong> Depakine Chrono 500 Acidum valproicum Prolonged release<br />

tablets<br />

3228 Depakote Divalproexum Gastro-resistant<br />

tablets<br />

3229 Depakote Divalproexum Gastro-resistant<br />

tablets<br />

300 mg Sanofi-Synthelabo Sp. z o.o. 31/03/07<br />

300 mg Sanofi Winthrop-Gentilly<br />

Cedex<br />

30/06/04<br />

500 mg Sanofi-Synthelabo Sp. z o.o. 31/03/07<br />

500 mg Sanofi Winthrop-Gentilly<br />

Cedex<br />

30/06/04<br />

250 mg Sanofi — Winthrop 31/12/08<br />

500 mg Sanofi — Winthrop 31/12/08<br />

3230 Depamide Valpromidum Film-coated tablets 300 mg Sanofi Winthrop-Gentilly 31/07/04<br />

3231 DE-PAR-VAC Szczepionka przeciw<br />

chorobie Derzsyego<br />

dla ge˛si i kaczek<br />

piz˙mowych<br />

3232 Depedin Veyx prednizolon,<br />

deksametazon<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

3233 Depherelin D-Phe6 gonadorelina Solution for veterinary<br />

use<br />

3234 Depogeston Medroxyprogesteronum Suspension for veterinary<br />

use<br />

3235 Depo-Medrol Methylprednisolonum Suspension for<br />

injection<br />

3236 Depo-Medrol Methylprednisolonum Suspension for<br />

injection<br />

3237 Depo-Medrol z Lidokaina˛ Lidocainum +<br />

Methylprednisolonum<br />

3238 Depo-Medrone V 20mg Methylprednisolini<br />

acetas<br />

Suspension for<br />

injection<br />

Ceva-Phylaxia Veterinary<br />

Biologicals<br />

8/04/04<br />

Veyx Pharma 31/12/08<br />

Veyx-Pharma 12/11/06<br />

Biowet Puławy Sp. z o.o. 8/05/05<br />

40 mg/1 ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/10/05<br />

40 mg/1 ml Pharmacia N.V./S.A. 30/06/04<br />

(10mg +<br />

40mg)/ml<br />

Suspension for veterinary<br />

use<br />

3239 Depo-Medrone V 40 mg Methylprednisolonum Suspension for veterinary<br />

use<br />

3240 Depomycin Benzylpenicillinum<br />

procainicum +<br />

Dihydrostreptomycinum<br />

Suspension for veterinary<br />

use<br />

3241 Depo-Promone Medroxyprogesteronum Suspension for veterinary<br />

use<br />

3242 Depo-Provera Medroxyprogesteronum Suspension for<br />

injection<br />

3243 Depo-Provera Medroxyprogesteronum Suspension for<br />

injection<br />

3244 Depo-Provera Medroxyprogesteronum Suspension for<br />

intramuscular<br />

injection<br />

Pharmacia N.V./S.A. 30/06/04<br />

Pharmacia N.V./S.A. 31/12/08<br />

Pharmacia N.V./S.A. 31/12/08<br />

Intervet International B.V. 27/02/07<br />

Pharmacia N.V./S.A. 31/12/08<br />

150 mg/ml Pharmacia N.V./S.A. 30/06/04<br />

50 mg/ml Pharmacia N.V./S.A. 30/06/04<br />

150 mg/1 ml Pharmacia N.V./S.A. 30/06/04


EN<br />

900 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3245 Depostat Gestonoroni caproas Solution for injection 100 mg/ml Schering AG 31/07/04<br />

3246 Deprenon Fluoxetinum Capsuels, hard 20 mg Slovakofarma a.s. 24/08/05<br />

3247 Depresol Hyperici herbae extr. sicc. Tablets 100 mg P.R.P Tymofarm, Jakubów 31/12/08<br />

3248 Depresol 300 Hyperici herbae extr. sicc. Tablets 300 mg P.R.P Tymofarm, Jakubów 31/12/08<br />

3249 Deprestonic Extr. fluidum ex:,<br />

Passiflorae herba, Lupuli<br />

strob., Valerianae radix<br />

Oral solution Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

3250 Deprexetin Fluoxetinum Capsules 20 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

3251 Deprexolet Mianserinum Film-coated tablets 10 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

3252 Deprexolet Mianserinum Film-coated tablets 30 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

3253 Deprim Hyperici herbae<br />

extractum siccum<br />

3254 Deprim forte Hypericiherbae extractum<br />

siccum<br />

3255 Deps Hyperici herba extractum<br />

siccum<br />

3256 Depulol Oleum rosmarini +<br />

Oleum elcalypti +<br />

Balsamum peruvianum<br />

31/12/08<br />

31/12/08<br />

Film-coated tablets 60 mg Lek Pharmaceuticals d.d. 31/03/07<br />

Capsules, hard 425 mg Lek Polska Sp. z o.o. 31/12/08<br />

Tablets 50 mg Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

Gel fof rub Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

3257 Derhotill Ointment Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

31/12/08<br />

31/12/08<br />

31/01/05<br />

3258 Dermabion Film-coated tablets Krka d.d., Novo mesto 31/07/04<br />

3259 Dermacorn Sulfanilamid, Tlenek<br />

cynku, Glukonian<br />

chlorheksydyny<br />

Ointment for veterinary<br />

use<br />

3260 Dermaknel Cream (40mg +<br />

10mg)/g<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

24/05/04<br />

31/01/06<br />

3261 Dermatol Cefarm Gdańsk 12/10/05<br />

3262 Dermatol Galenus, Warszawa 12/10/05<br />

3263 Dermatol Hasco-Lek, Wrocław 12/10/05<br />

3264 Dermatol Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

12/10/05<br />

3265 Dermatol Maga-Herba s.c., Legionowo 12/10/05<br />

3266 Dermatol PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

12/10/05<br />

3267 Dermazin Sulfadiazinum Cream 10 mg/g Lek Pharmaceuticals d.d. 30/04/04<br />

3268 Der-Med Dinatrii<br />

undecylyloxyethylamidosulfosuccinas<br />

Cutaneous emulsion 30 mcg/g Permamed Laboratories Ltd. 30/09/04<br />

3269 Dermestril 25 Estradiolum Transdermal patch 25 mcg/24 h Rottapharm S.r.I 31/12/08<br />

3270 Dermestril 50 Estradiolum Transdermal patch 50 mcg/24 h Rottapharm S.r.I 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 901<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3271 Dermestril — Septem 25 Estradiolum Transdermal patch 2,5 mg<br />

estradiolu<br />

(25 mcg/<br />

dawke˛)<br />

3272 Dermestril — Septem 50 Estradiolum Transdermal patch 5,0 mg<br />

estradiolu<br />

(50 mcg/<br />

dawke˛)<br />

3273 Dermestril — Septem 75 Estradiolum Transdermal patch 7,5 mg<br />

estradiolu<br />

(75 mcg/<br />

dawke˛)<br />

Rottapharm S.r.l. 26/09/07<br />

Rottapharm S.r.l. 26/09/07<br />

Rottapharm S.r.l. 26/09/07<br />

3274 Dermestril 100 Estradiolum Transdermal patch 100 mcg/24 h Rottapharm S.r.I 31/12/08<br />

3275 Dermklobal Clobetasolum Cream 0.5 mg/g Polmex Sp. z o.o. 29/06/05<br />

3276 Dermklobal Clobetasolum Ointment 0.5 mg/g Polmex Sp. z o.o. 29/06/05<br />

3277 Dermklobal Clobetasolum Solution for haired<br />

head skin<br />

3278 Dermo G spray Gentamycyna,<br />

betametazon<br />

Spray for veterinary<br />

use<br />

0.5 mg/g Polmex Sp. z o.o. 29/06/05<br />

Lek Pharmaceuticals 31/12/08<br />

3279 Dermobonisol Coutanous liquid Laboratorium Medycyny<br />

Naturalnej ‘BONIMED’,<br />

Z˙ywiec<br />

3280 Dermocin - Mupirocinum Cutaneous spray Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3281 Dermocin S Mupirocinum Gel 2 % Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3282 Dermocin W Mupirocinum Gel 2 % Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3283 Dermodrin Diphenhydraminum Medicated powder 30 mg/g Pharmaceutische Fabrik<br />

Montavit GmbH<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/10/04<br />

3284 Dermofix Sertaconazolum Pessary 300 mg Ferrer Internacional S.A. 31/12/08<br />

3285 Dermogal Oenotherae oleum +<br />

Tocopherolum<br />

Capsule, soft 490 mg +<br />

10 mg<br />

Specjalistyczne<br />

Przedsie˛biorstwo Rolno-<br />

Przetwórcze ‘GAL’ s.c.<br />

3286 Dermopanten Dexpanthenolum Ointment 50 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

3287 Dermophenazol Antazolinum +<br />

Naphazolinum<br />

Cutaneous spray,<br />

solution<br />

(5mg +<br />

0,25mg)/ml<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

3288 Dermopur Benzocainum Liquid powder 15 mg/g Prolab s.c. — Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Produkcyjno-Analityczno-<br />

Handlowe s.c. Paterek<br />

3289 Dermoretin Retinolum Ointment 800 j./g Cefarm Gdańsk<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

3290 Dermosavit Retinolum Ointment 500 j.m./g Coel s.c.- Laboratorium<br />

Farmaceutyczne Wytwórnia<br />

Euceryny<br />

3293 Dermovate Clobetasolum Coutanous liquid 0.5 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/12/08<br />

14/12/05<br />

14/02/07<br />

30/06/05<br />

30/10/05<br />

31/01/06<br />

31/03/04


EN<br />

902 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3291 Dermovate Clobetasolum Cream 0.5 mg/g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

3292 Dermovate Clobetasolum Ointment 0.5 mg/g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

3294 Dermovit A Retinolum Ointment 500 j.m./g Coel s.c.- Laboratorium<br />

Farmaceutyczne Wytwórnia<br />

Euceryny<br />

3295 Dermovit E Tocopherolum Ointment 20 mg/g Coel s.c.- Laboratorium<br />

Farmaceutyczne Wytwórnia<br />

Euceryny<br />

3296 Dermovit F Vitaminum F Ointment 25 mg/g Coel s.c.- Laboratorium<br />

Farmaceutyczne Wytwórnia<br />

Euceryny<br />

3297 Dernilan Ointment Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

3298 Dervac Szczepionka przeciw<br />

chorobie Derzsyego<br />

dla ge˛si i kaczek<br />

Barbarie oraz Mullard<br />

Lyophilisate for veterinary<br />

use<br />

3299 Desferal Deferoxaminum Powder for solution<br />

for injection<br />

3300 Desin Jod, Jodek potasowy,<br />

Fluoroscenian sodu,<br />

Z˙ółcień metanilowa<br />

Solution for veterinary<br />

use<br />

3301 Desin Forte Preparat złoz˙ony Solution for veterinary<br />

use<br />

Państwowy Instytut<br />

Weterynaryjny<br />

9/08/05<br />

31/03/04<br />

31/01/06<br />

31/01/06<br />

31/12/05<br />

26/09/07<br />

31/12/08<br />

500 mg Novartis Pharma AG 31/07/04<br />

Przedsie˛biorstwo Tropical 31/12/08<br />

Przedsie˛biorstwo Tropical 18/09/07<br />

3302 Desmopryn Desmopressinum Nasal drops 0,1 mg/ml TERPOL Przedsiebiorstwo<br />

Farmaceutyczne S.A<br />

3303 Desparin Drotraverini<br />

hydrochloridum<br />

Tablets 40 mg Medana Pharma Terpol<br />

Group S.A.<br />

31/12/08<br />

14/02/07<br />

3304 Desson Preparat złoz˙ony Liquid ICN Polfa Rzeszów S.A. 30/09/05<br />

3305 Detosol Preparat złoz˙ony Coutanous liquid Profarm — Przedsie˛biorstwo<br />

Produkcji Farmaceutyczno-<br />

Kosmetycznej Sp. z o.o.<br />

3306 Detralex Diosminum +<br />

Hesperydyna<br />

Film-coated tablets 450mg +<br />

50mg<br />

3307 Detreomycyna 1 % Chloramphenicolum Ointment 10 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

3308 Detreomycyna 2 % Chloramphenicolum Ointment 20 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

12/10/05<br />

Les Laboratoires Servier 30/06/04<br />

30/06/06<br />

30/06/06<br />

3309 Detrusitol Tolterodinum Film-coated tablets 1 mg Pharmacia AB 31/08/04<br />

3310 Detrusitol Tolterodinum Film-coated tablets 2 mg Pharmacia A.B. 31/08/04<br />

3311 Devisol-25 Calcifediolum Oral drops, solution 0.15 mg/1 ml Instytut Farmaceutyczny 30/11/05<br />

3312 Dexadent Dexamethasonum +<br />

Framycetinum +<br />

Polymyxinum B<br />

Ointment (10mg + 25mg<br />

+ 2,5mg)/g<br />

3313 Dexafort Deksametazon Suspension for veterinary<br />

use<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

Intervet 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 903<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3314 Dexagel Dexamethasonum Eye gel 0,985 mg/ml Dr Gerhard Mann 31/12/08<br />

3315 Dexamethason Dexamethasonum Solution for injection 4 mg/1 ml Krka d.d., Novo mesto 31/07/04<br />

3316 Dexamethason Dexamethasonum Tablets 1 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

3317 Dexamethason Dexamethasonum Tablets 500 mcg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

3318 Dexamethason 0,1 % Dexamethasonum Eye drops, suspension 1 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

3319 Dexamethasone 0,2 % pro inj. Dexamethasonum Solution for veterinary<br />

use<br />

3320 Dexamytrex Dexamethasonum +<br />

Gentamicinum<br />

3321 Dexamytrex Dexamethasonum +<br />

Gentamicinum<br />

Vetimex Animal Health (od<br />

01.01.2001r. Eurovet<br />

International)<br />

Eye drops Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

Eye ointment Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

3322 Dexapolcort Dexamethasonum Cutaneous spray 0.15 mg/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3323 Dexapolcort N Dexamethasonum +<br />

Neomycinum<br />

3324 Dexasone Fosforanu<br />

deksametazonu sól<br />

sodowa<br />

Cutaneous spray (150mcg +<br />

750mcg)/ ml<br />

Solution for veterinary<br />

use<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/05<br />

31/12/05<br />

30/11/05<br />

23/01/05<br />

2/02/06<br />

2/02/06<br />

31/05/06<br />

30/09/05<br />

Norbrook Lab. 28/06/04<br />

3325 Dexatussin Dextromethorphanum Syrup 1 mg/ml Espefa Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

3326 Dexatussin Dextromethorphanum Syrup 2 mg/ml Espefa Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

3327 Dexaven Dexamethasonum Solution for injection 4 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

3328 Dexibuprofen Dexibuprofenum Capsules, soft 200 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

3329 Dexoryl Gentamycyny siarczan,<br />

Tiabendazol,<br />

Deksametazon<br />

Ear drops for veterinary<br />

use<br />

31/01/06<br />

31/01/06<br />

30/11/05<br />

31/12/08<br />

Virbac 17/08/05<br />

3330 Dexprofen 150 Dexibuprofenum Tablets 150 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3331 Dexprofen 300 Dexibuprofenum Tablets 300 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3332 Dexprofen 450 Dexibuprofenum Tablets 450 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3333 Dezorol Acidum salicylicum +<br />

Mentholum +<br />

Methenaminum<br />

3334 DHC Continus Dihydrocodeini tartras Modified release<br />

tablets<br />

3335 DHC Continus Dihydrocodeini tartras Modified release<br />

tablets<br />

Coutanous liquid Profarm — Przedsie˛biorstwo<br />

Produkcji Farmaceutyczno-<br />

Kosmetycznej Sp. z o.o.<br />

120 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

60 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/06/06<br />

30/06/06<br />

30/06/06<br />

31/05/06<br />

25/10/06<br />

25/10/06


EN<br />

904 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3336 DHC Continus Dihydrocodeini tartras Modified release<br />

tablets<br />

90 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

25/10/06<br />

3337 DHEA Dehydroepiandrosterone Capsules 20 mg K&K Medicplast 31/12/08<br />

3338 DHEA Dehydroepiandrosterone Capsules 50 mg K&K Medicplast 31/12/08<br />

3339 DHEA Dehydroepiandrosterone Capsules 100 mg K&K Medicplast 31/12/08<br />

3340 Dhea Dehydroepiandrosteronum Tablets 10 mg Medana Pharma TERPOL<br />

Group S.A.<br />

3341 Dhea Dehydroepiandrosteronum Tablets 25 mg Medana Pharma TERPOL<br />

Group S.A.<br />

31/12/08<br />

31/12/08<br />

3342 Dhea Dehydroepiandrosteronum Tablets 10 mg Labpharm Sp. z o.o. 31/12/08<br />

3343 Dhea Dehydroepiandrosteronum Tablets 25 mg Labpharm Sp. z o.o. 31/12/08<br />

3344 Dhea Dehydroepiandrosteronum Tablets 50 mg Labpharm Sp. z o.o. 31/12/08<br />

3345 Dhea DHEA Tablets 15 mg Omega Rex s.j. 31/12/08<br />

3346 Dhea DHEA Tablets 25 mg Omega Rex s.j. 31/12/08<br />

3347 Dhea 10 Dehydroepiandrosteronum Tablets 10 mg Produkcyjno-Handlowe<br />

Przedsie˛biorstwo<br />

Farmaceutyków CURTIS<br />

HEEALTHCARE Sp. z.o.o.<br />

3348 Dhea 25 Dehydroepiandrosteronum Tablets 25 mg Produkcyjno-Handlowe<br />

Przedsie˛biorstwo<br />

Farmaceutyków CURTIS<br />

HEEALTHCARE Sp. z.o.o.<br />

3349 DHEA 25 mg Dehydroepiandrosteronum Film-coated tablets 25 mg Hurtownia Farmaceutyczna<br />

‘Eljot’<br />

3350 Dhea 50 Dehydroepiandrosteronum Tablets 50 mg Produkcyjno-Handlowe<br />

Przedsie˛biorstwo<br />

Farmaceutyków CURTIS<br />

HEEALTHCARE Sp. z.o.o.<br />

3351 Diaben Preparat dietetyczny Liquid 500 ml,<br />

1000 ml,<br />

1500 ml<br />

Fresenius Kabi Deutschland<br />

GmbH<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

3352 Diabene Drops Lehning Laboratoires 31/12/08<br />

3353 Diabetex-fix Species<br />

antidiabeticae<br />

Preparat ziołowy Instant herbal tea Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

31/08/05<br />

3354 Diabetin fix Herbal tea Herbapol Lublin S.A. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 905<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3355 Diabetina Herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

3356 Diabetina Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

3357 Diabetobonisan Instant herbal tea Laboratorium Medycyny<br />

Naturalnej BONIMED, Z˙ywiec<br />

3358 Diabetobonisol Oral solution Laboratorium Medycyny<br />

Naturalnej BONIMED, Z˙ywiec<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

3359 Diabetofort Oral solution Dar Natury P.P.H. 6/06/07<br />

3360 Diabetogran Preparat ziołowy Granules Herbapol Łódz´ S.A. 31/01/05<br />

3361 Diabetol Tolbutamidum Tablets 500 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/01/06<br />

3362 Diabetomix Herba Oskar, Wierzbówiec 31/12/08<br />

3363 Diabetosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 31/08/05<br />

3364 Diabetosan fix Mieszanka ziołowa Instant herbal tea Herbapol Łódz´ S.A. 30/06/06<br />

3365 Diabetosol Preparat ziołowy Oral solution Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

3366 Diabeto-Var Instant herbal tea Varia — Zakłady Zielarsko-<br />

Farmaceutyczne Sp. z o.o.<br />

30/09/05<br />

31/01/06<br />

3367 Diabeto-var Varia, Katowice 31/01/06<br />

3368 Diabetovit Herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

3369 Diabetovit Instant herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

3370 Diabetussic Guaiacolsulfonatum Liquid 6 g/100 g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

3371 Diabezidum Gliclazidum Tablets 80 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

3372 Diabinese Chlorpropamidum Tablets 250 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

3373 Diabrezide Gliclazidum Tablets 80 mg L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

30/10/05<br />

31/03/07<br />

31/12/08<br />

4/12/06<br />

30/06/04<br />

9/06/05<br />

3374 Diacordin Diltiazemum Tablets 60 mg Lečiva a.s. 30/08/04<br />

3375 Diacordin 90 Retard Diltiazemum Film-coated, slow<br />

release tablets<br />

90 mg Lečiva a.s. 30/09/07<br />

3376 Diaklat Gliclazidum Tablets 80 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

3377 Diane 35 Cyproteronum +<br />

Ethinylestradiolum<br />

3378 Diaprel Gliclazidum Prolonged release<br />

tablets<br />

3379 Diaprel MR Gliclazidum Modified release<br />

tablets<br />

13/09/06<br />

Film-coated tablets Schering AG 31/07/04<br />

80 mg Les Laboratoires Servier 31/07/04<br />

30 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/05/06


EN<br />

906 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3380 Diarrheel S Sublingual tablets Heel GmbH 31/12/08<br />

3381 Diarroten — fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp. z<br />

o.o. — Zastawna<br />

30/10/05<br />

3382 Diastabol 100 Miglitolum Tablets 100 mg Sanofi Winthrop-Gentilly 31/07/05<br />

3383 Diastabol 50 Miglitolum Tablets 50 mg Sanofi Winthrop-Gentilly 31/07/05<br />

3384 Diazepam RecTubes Diazepamum Rectal solution 2 mg/ml Desitin Arznemittel GmbH 30/06/07<br />

3385 Diazepam RecTubes Diazepamum Rectal solution 4 mg/ml Desitin Arznemittel GmbH 30/06/07<br />

3386 Diazepam-Lipuro Diazepamum Emulsion for<br />

intravenous or<br />

intramuscular<br />

injection<br />

5 mg/ml B. Braun Melsungen AG 31/01/05<br />

3387 Diazerekt Diazepamum Rectal infusion 5 mg/2,5 ml Zakłady Farmaceutyczno —<br />

Aerozolowe ‘UNIA’<br />

Spółdzielnia Pracy<br />

3388 Diazerekt Diazepamum Rectal infusion 10 mg/2,5 ml Zakłady Farmaceutyczno —<br />

Aerozolowe ‘UNIA’<br />

Spółdzielnia Pracy<br />

27/06/07<br />

27/06/07<br />

3389 Diazidan Gliclazidum Tablets 80 mg ICN Polfa Rzeszów S.A. 25/10/06<br />

3390 Diclac Diclofenacum Solution for<br />

intramuscular<br />

injection<br />

75 mg/3 ml Hexal AG 31/12/08<br />

3391 Diclac 100 Diclofenacum Suppository 100 mg Hexal AG 31/07/04<br />

3392 Diclac 150 Duo Diclofenacum Modified release<br />

tablets<br />

3393 Diclac 25 Diclofenacum Film-coated,<br />

gastro-resistant tablets<br />

3395 Diclac 50 Diclofenacum Film-coated,<br />

gastro-resistant tablets<br />

150 mg Hexal AG 4/07/07<br />

25 mg Hexal AG 30/06/07<br />

50 mg Hexal AG 31/07/04<br />

3394 Diclac 50 Diclofenacum Suppository 50 mg Hexal AG 31/07/04<br />

3396 Diclac 75 Duo Diclofenacum Modified release<br />

tablets<br />

75 mg Hexal AG 4/07/07<br />

3397 Diclac Lipogel Diclofenacum Gel (1 %) 10 mg/g Ecosol AG 31/12/08<br />

3398 Dicloberl 50 Diclofenacum Suppository 50 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

3399 Dicloberl retard Diclofenacum Prolonged release<br />

capsules<br />

100 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

30/06/04<br />

31/05/05<br />

3400 Diclobion Diclofenacum Eye drops 1 mg/ml Bioton Sp. z o.o. 31/12/08<br />

3401 DicloDuo Diclofenacum Capsules with<br />

gastro-resistant,<br />

prolonged release<br />

pelets<br />

75 mg Pharmavit Kft. 31/12/08<br />

3402 Diclofenac — Ophtha Diclofenacum Eye drops 1 mg/ml Laboratoires CIBAVISION<br />

Foure<br />

3403 Diclofenac 100 Diclofenacum Suppository 100 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

3404 Diclofenac 100 Stada Retard Diclofenacum Modified release<br />

tablets<br />

31/12/08<br />

31/12/05<br />

100 mg Stada Arzneimittel AG 31/07/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 907<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3405 Diclofenac 25 Diclofenacum Film-coated,<br />

gastro-resistant tablets<br />

3407 Diclofenac 50 Diclofenacum Film-coated,<br />

gastro-resistant tablets<br />

3408 Diclofenac 50 Diclofenacum Film-coated,<br />

gastro-resistant tablets<br />

25 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

50 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/05<br />

50 mg Polfarmex Sp. z o.o. 31/12/05<br />

3406 Diclofenac 50 Diclofenacum Suppository 50 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

3409 Diclofenac Al 25 Diclofenacum Tablets 25 mg ALIUD Pharma GmbH & Co.<br />

KG<br />

3410 Diclofenac Al 50 Diclofenacum Tablets 50 mg ALIUD Pharma GmbH & Co.<br />

KG<br />

3411 DICLOFENAC Emulgel Diclofenacum Gel 1 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

31/12/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

3412 Diclofenac Sodium E/C Diclofenacum Film-coated tablets 50 mg Norton Healthcare Ltd. 30/06/04<br />

3413 Diclofenac Sr 100 Diclofenacum Prolonged release<br />

tablets<br />

3414 Dicloratio Diclofenacum Gel 1 % (0,01 g/<br />

1 ml)<br />

3415 Dicloratio Diclofenacum +<br />

Lidocainum<br />

Solution for<br />

intramuscular<br />

injection<br />

3417 Dicloratio 25 Diclofenacum Gastro-resistant<br />

tablets<br />

100 mg Polfarmex Sp. z o.o. 31/12/08<br />

(75mg +<br />

20mg)/2ml<br />

ratiopharm GmbH 30/06/04<br />

ratiopharm GmbH 30/06/04<br />

25 mg ratiopharm GmbH 30/04/04<br />

3416 Dicloratio 25 Diclofenacum Suppository 25 mg ratiopharm GmbH 30/04/04<br />

3418 Dicloratio 50 Diclofenacum Suppository 50 mg ratiopharm GmbH 30/04/04<br />

3419 Dicloratio 100 Diclofenacum Suppository 100 mg ratiopharm GmbH 30/04/04<br />

3420 Dicloratio 50 Diclofenacum Gastro-resistant<br />

tablets<br />

3421 Dicloratio Retard 100 Diclofenacum Prolonged release<br />

capsules<br />

3422 Dicloratio Uno Diclofenacum Modified release<br />

tablets<br />

3425 Dicloreum Diclofenacum Film-coated,<br />

gastro-resistant tablets<br />

50 mg ratiopharm GmbH 30/06/04<br />

100 mg ratiopharm GmbH 30/04/04<br />

150 mg ratiopharm GmbH 31/12/04<br />

50 mg Alfa Wassermann S.p.A. 30/06/04<br />

3424 Dicloreum Diclofenacum Solution for injection 25 mg/ml Alfa Wassermann S.p.A. 30/06/04<br />

3423 Dicloreum Diclofenacum Suppository 100 mg Alfa Wassermann S.p.A. 30/06/04<br />

3426 Dicloreum retard Diclofenacum Prolonged release<br />

tablets<br />

3427 DICLOTARD 100 mg Diclofenacum Film-coated,<br />

prolonged release<br />

tablets<br />

3428 Dicortineff Fludrocortisonum +<br />

Gramicidinum +<br />

Neomycinum<br />

3429 Dicortineff Fludrocortisonum +<br />

Gramicidinum +<br />

Neomycinum<br />

Ear and eye drops,<br />

suspension<br />

100 mg Alfa Wassermann S.p.A. 30/04/04<br />

100 mg S.C. Terapia S.A. 31/12/08<br />

(1mg +<br />

0,025mg +<br />

2,5mg)/ml<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Eye ointment Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/01/06<br />

31/12/08


EN<br />

908 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3430 Dicortineff -Vet Neomycinum +<br />

Gramicidinum +<br />

Fluorokortisonum<br />

3431 Dicural Difloksacyny<br />

chlorowodorek<br />

3432 Dicural 100 Difloksacyny<br />

chlorowodorek<br />

3433 Dicural 15 Difloksacyny<br />

chlorowodorek<br />

3434 Dicural 50 Difloksacyny<br />

chlorowodorek<br />

3435 Dietalek Odz˙ywka Powder for<br />

suspension<br />

3436 Diet-scour Ampicillinum,<br />

vitamins,<br />

microelements<br />

3437 Difadol Diclofenacum Solution for<br />

intramuscular<br />

injection<br />

Suspension for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Warszawskie Zkłady<br />

Farmaceutyczne ‘Polfa’<br />

31/12/08<br />

Fort Dodge Veterianria S.A. 29/06/06<br />

Fort Dodge Animal Health 12/07/06<br />

Fort Dodge Animal Health 12/07/06<br />

Fort Dodge Animal Health 12/07/06<br />

BTL Sp. z o.o. Zakład<br />

Enzymów i Peptonów, Łódz´<br />

31/12/08<br />

Virbac 23/11/04<br />

75 mg/3 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

3438 Difadol 0,1 % Diclofenacum Eye drops 1 mg / ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

31/12/08<br />

3439 Difen — Ud Diclofenacum Eye drops 1 mg/ml Pharma Stulln GmbH 31/12/08<br />

3440 Differin Adapalenum Cream 1 mg/g Laboratoires Galderma S.A.<br />

Tour Europlaza<br />

3441 Differin Adapalenum Gel 1 mg/g Laboratoires Galderma S.A.<br />

Tour Europlaza<br />

20/05/04<br />

29/06/04<br />

3442 Diflazon Fluconazolum Capsules 50 mg KRKA d.d., Novo mesto 31/12/08<br />

3443 Diflazon Fluconazolum Capsules 100 mg KRKA d.d., Novo mesto 31/12/08<br />

3444 Diflazon Fluconazolum Capsules 150 mg KRKA d.d., Novo mesto 31/12/08<br />

3445 Diflazon Fluconazolum Capsules 200 mg KRKA d.d., Novo mesto 31/12/08<br />

3446 Diflazon Fluconazolum Solution for<br />

intravenous infusion<br />

3447 Difloxy 10 % oral Difloksacyna Solution for veterinary<br />

use<br />

2 mg/ml KRKA d.d., Novo mesto 31/12/08<br />

Lavet 31/12/08<br />

3448 Diflucan Fluconazolum Capsules 100 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

3449 Diflucan Fluconazolum Capsules 150 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

3450 Diflucan Fluconazolum Capsules 200 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

3451 Diflucan Fluconazolum Capsules 50 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

3452 Diflucan Fluconazolum Solution for<br />

intravenous infusion<br />

2 mg/ml Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 909<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3453 Diflucan Fluconazolum Syrup 5 mg/ml Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

30/04/04<br />

3454 Difosfen Dinatrii etidronas Tablets 200 mg Rubio Laboratorios S.A. 30/11/04<br />

3455 Difrarel 100 Myrtilli fructus extractum<br />

siccum<br />

3456 Diftosec CT Z˙ywa szczepionka dla<br />

kur przeciw ospie<br />

ptaków<br />

Coated tablets 100 mg Laboratoires LERQUIN<br />

MEDIOLANUM, Francja<br />

Lyophilisate + solvent for veterinary<br />

use<br />

31/12/08<br />

Merial SAS 24/05/07<br />

3457 Digesan Liquid Bittner Richard GmbH 31/12/07<br />

3458 Digesflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

3459 Digestiol Cynareae herbae<br />

extractum siccum<br />

Capsules, hard 170 mg Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

29/01/06<br />

31/12/08<br />

3460 Digestodoron N krople WELEDA 24/08/05<br />

3461 Diges-Tonic Preparat ziołowy Oral solution Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

31/08/05<br />

3462 Digestosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 31/08/05<br />

3463 Diglical Gliclazidum Tablets 80 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

3464 Digoxin Digoxinum Solution for injection 0.25 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

3465 Digoxin Digoxinum Tablets 100 mcg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3466 Digoxin Digoxinum Tablets 250 mcg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3467 Digoxin Digoxinum Tablets 250 mcg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

3468 Dih Diosminum +<br />

Hesperidinum<br />

Film-coated tablets 450 mg +<br />

50 mg<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

3469 Dihydralazinum Dihydralazinum Tablets 25 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

3470 Dihydroergotaminum<br />

methanosulfonicum<br />

3471 Dihydroergotaminum<br />

tartaricum<br />

3472 Dihydroergotoxinum<br />

aethanosulfonicum<br />

3473 Dihydroergotoxinum<br />

aethanosulfonicum<br />

3474 Dihydrokodeiny wodorowinian<br />

Dihydroergotaminum Oral solution 2 mg/g Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

Dihydroergotaminum Tablets 1 mg Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

Dihydroergotoxinum Oral solution 1 mg/ml Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

Dihydroergotoxinum Sublingual tablets 0.25 mg Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

3475 Dikamfen Preparat złoz˙ony Liquid Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

31/12/08<br />

30/01/05<br />

30/10/05<br />

31/12/05<br />

30/10/05<br />

31/12/08<br />

31/12/05<br />

31/01/06<br />

31/01/06<br />

31/12/07<br />

31/12/07<br />

Polfa Kutno 16/01/06<br />

3477 Diklonat P Diclofenacum Gel 10 mg/g PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/10/05<br />

31/12/08


EN<br />

910 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3476 Diklonat P Diclofenacum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

3478 DIKLONAT P Forte Diclofenacum Gastro-resistant<br />

tablets<br />

75 mg/ml PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

50 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

3479 Diklonat P Rapid Diclofenacum Coated tablets 50 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

3480 Diklonat P Retard Diclofenacum Prolonged release<br />

tablets<br />

100 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

3481 Diklozen Diclofenacum Gel 1 % (10 mg/g) ZIAJA Ltd. Zakład<br />

Produkcyjny Gdańsk<br />

3482 Dilatrend Carvedilolum Tablets 12.5 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

3483 Dilatrend Carvedilolum Tablets 25 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

3484 Dilatrend Carvedilolum Tablets 6.25 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

3485 Dilocard Diltiazemum Prolonged release<br />

capsules<br />

3486 Dilocard Diltiazemum Prolonged release<br />

capsules<br />

3491 Diltiazem Diltiazemum Film-coated, controled<br />

release tablets<br />

3492 Diltiazem Diltiazemum Film-coated,<br />

prolonged release<br />

tablets<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/06/07<br />

30/06/07<br />

30/06/07<br />

90 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

120 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

120 mg Polfarmex S.A. 30/10/05<br />

180 mg Polfarmex S.A. 30/10/05<br />

3487 Diltiazem Diltiazemum Tablets 30 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

3488 Diltiazem Diltiazemum Tablets 30 mg Polfarmex S.A 31/01/05<br />

3489 Diltiazem Diltiazemum Tablets 60 mg Norton Healthcare Ltd. 30/06/04<br />

3490 Diltiazem Diltiazemum Tablets 60 mg Polfarmex S.A. 30/10/05<br />

3493 Diltiazem Retard Diltiazemum Film-coated tablets 90 mg Polfarmex S.A. 31/12/08<br />

3494 Dilzem Diltiazemum Tablets 60 mg Gödecke AG 31/07/04<br />

3495 Dilzem 120 retard Diltiazemum Prolonged release<br />

tablets<br />

3496 Dilzem 180 retard Diltiazemum Prolonged release<br />

tablets<br />

3497 Dilzem 25 Diltiazemum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

120 mg Parke-Davis GmbH —<br />

Freiburg<br />

180 mg Parke-Davis GmbH —<br />

Freiburg<br />

30/04/05<br />

30/04/05<br />

25 mg Gödecke AG 31/07/04<br />

3498 Dilzem retard Diltiazemum Film-coated tablets 90 mg Gödecke AG 31/07/04<br />

3499 Dimetinden Dimetindenum Gel 0,10 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 911<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3500 Dindoral Szczepionka dla<br />

indyków i baz˙antów<br />

przeciw<br />

krwotocznemu<br />

zapaleniu jelit indyków<br />

i chorobie<br />

marmurkowatej<br />

s´ledziony baz˙antów.<br />

Lyophilisate for veterinary<br />

use<br />

3501 Dinolytic Dinoprost Solution for veterinary<br />

use<br />

3502 Diosmin I Hesperidin Diosminum +<br />

Hesperidinum<br />

3503 Diosminex Diosminum +<br />

Hesperydynum<br />

Film-coated tablet 450 mg i<br />

50 mg<br />

Tablets 450 mg +<br />

50 mg<br />

Merial 19/07/05<br />

Pharmacia N.V./S.A. 18/03/04<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

31/12/08<br />

31/12/08<br />

3504 Diosmynin Diosminum Film-coated tablets 50 mg Kenay A.G., Cze˛stochowa 31/12/08<br />

3505 Diovan Valsartanum Film-coated tablets 160 mg Novartis Pharma AG 14/02/07<br />

3506 Diovan Valsartanum Film-coated tablets 80 mg Novartis Pharma AG 14/02/07<br />

3507 Diovan 160 Valsartanum Capsules 160 mg Novartis Pharma AG 31/12/08<br />

3508 Diovan 80 Valsartanum Capsules 80 mg Novartis Pharma AG 31/12/08<br />

3509 Dipeptiven Preparat odz˙ywczy Solution for<br />

parenteral nutrition<br />

3510 Diphereline 0,1 mg Triptorelinum Powder and solvent<br />

for solution for<br />

subcutaneous<br />

injection<br />

3511 Diphereline S.R. 3,75 Triptorelinum Lyophilisate and<br />

solvent for prolonged<br />

release suspension for<br />

intramuscular<br />

injection<br />

3512 Diphereline SR 11.25mg Triptorelinum Powder and solvent<br />

for prolonged release<br />

suspension for<br />

intramuscular<br />

injection<br />

20 g/100 ml Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

31/12/07<br />

0.1 mg Ipsen Biotech 21/06/06<br />

3.75 mg Pharma Biotech- Paris 31/05/05<br />

11.25 mg Ipsen Biotech 9/08/06<br />

3513 Diphergan Promethazinum Coated tablets 10 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

3514 Diphergan Promethazinum Coated tablets 25 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

3515 Diphergan Promethazinum Solution for injection 25 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

3516 Diphergan Promethazinum Syrup 5 mg/5ml Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

31/12/05<br />

3517 Diprivan Propofolum Emulsion for injection 10 mg/ml AstraZeneca UK Ltd. 31/07/04<br />

3518 Diprobase Chlorocresolum Cream Schering-Plough Labo N.V. 31/12/08<br />

3519 Diprobase Podłoz˙e mas´ciowe Ointment Schering-Plough Labo N.V. 31/12/08<br />

3520 Diprofilina Pliva Kraków 14/01/06<br />

3521 Diprogenta Betamethasonum +<br />

Gentamicinum<br />

Cream Schering-Plough Labo N.V. 30/09/04


EN<br />

912 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3522 Diprogenta Betamethasonum +<br />

Gentamicinum<br />

Ointment Schering-Plough Labo N.V. 30/09/04<br />

3523 Diprolene Betamethasonum Cream 0.5 mg/g Schering-Plough Labo N.V. 12/06/06<br />

3524 Diprolene Betamethasonum Ointment 0.5 mg/g Schering-Plough Labo N.V. 12/06/06<br />

3525 Dipromal Acidum valproicum Film-coated tablets 200 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

3526 Diprophos Betamethasonum Suspension for<br />

injection<br />

3527 Diprophyllinum Diprophyllinum Solution for<br />

intravenous injection<br />

7 mg/ml Schering-Plough Labo N.V. 31/05/04<br />

25 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

3528 Diprophyllinum Diprophyllinum Tablets 200 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

3529 Diprophyllinum prolongatum Diprophyllinum Prolonged release<br />

tablets<br />

3530 Diprophyllinum prolongatum Diprophyllinum Prolonged release<br />

tablets<br />

3531 Diprosalic Acidum salicylicum +<br />

Betamethasonum<br />

3532 Diprosalic Acidum salicylicum +<br />

Betamethasonum<br />

250 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

450 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/09/05<br />

30/09/05<br />

30/09/05<br />

30/09/05<br />

Ointment Schering-Plough Labo N.V. 28/06/05<br />

Solution for external<br />

use<br />

Schering-Plough Labo N.V. 28/06/05<br />

3533 Diprosone Betamethasonum Crem for external use 0.5 mg/g Schering-Plough Labo N.V. 28/06/05<br />

3534 Diprosone Betamethasonum Ointment for external<br />

use<br />

3535 Dirigestran inj. Gonadorelinum Solution for veterinary<br />

use<br />

0.5 mg/g Schering-Plough Labo N.V. 28/06/05<br />

Ferring-Leciva a.s. 3/08/06<br />

3536 Diroton Lisinoprilum Tablets 10 mg Gedeon Richter Ltd. 31/01/05<br />

3537 Diroton Lisinoprilum Tablets 2.5 mg Gedeon Richter Ltd. 21/06/06<br />

3538 Diroton Lisinoprilum Tablets 20 mg Gedeon Richter Ltd. 31/01/05<br />

3539 Diroton Lisinoprilum Tablets 5 mg Gedeon Richter Ltd. 31/01/05<br />

3540 Disalunil Hydrochlorothiazidum Tablets 25 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

3541 DISCI comp. cum Argento<br />

ampułki<br />

3542 DISCI comp. cum Argento<br />

granulki<br />

31/01/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

3543 DISCI comp. Cum Stanno Amp. 1 ml, 10 ml WALA-Heilmittel GmbH 24/05/07<br />

3544 Disci comp.cum Stanno Granules WALA-Heilmittel GmbH 24/05/07<br />

3545 Disci/Rhus toxicodendron<br />

comp. inj.<br />

3546 DISCI/VISCUM comp. cum<br />

Stanno gran.<br />

3547 DISCI/VISCUM comp. cum<br />

Stanno amp.<br />

3548 DISCI/VISCUM comp. cum<br />

Stanno ung.<br />

WALA-Heilmittel GmbH 31/08/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 913<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3549 Disci/Viscum comp.cum<br />

Argento<br />

Suppository 2g WALA-Heilmittel GmbH 24/05/07<br />

3550 Discus compositum Amp. Heel GmbH 31/12/07<br />

3551 Disflatyl Simeticonum Oral drops 40 mg /1 ml ICN Switzerland AG 27/04/05<br />

3552 Disflatyl Simeticonum Tablets 40 mg ICN Switzerland AG 31/12/07<br />

3553 Disgren Triflusalum Capsules 300 mg URIACH (Medagro) 31/12/08<br />

3554 Disocor Disopyramidum Capsules 100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

3555 Disophrol Retard Dexbrompheniraminum<br />

+ Pseudoephedrinum<br />

Prolonged release<br />

tablets<br />

30/10/05<br />

Schering-Plough Labo N.V. 31/05/04<br />

3556 Dissenten Loperamidum Tablets 2 mg SPA Societa Prodotti<br />

Antibiotici SpA<br />

3557 Distemink Atenuowana<br />

szczepionka dla norek<br />

przeciw nosówce<br />

3558 Distrept 25 % Siarczan<br />

dihydrostreptomycyny<br />

3561 Distreptaza Streptodornasum +<br />

Streptokinasum<br />

3562 Distreptaza Streptodornasum +<br />

Streptokinasum<br />

3559 Distreptaza Streptodornasum +<br />

Streptokinasum<br />

3560 Distreptaza Streptodornasum +<br />

Streptokinasum<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Lyophilisate for<br />

solution for injection<br />

Oromucosal tablets (muco-adhesive<br />

buccal tablets, sublingual tablets)<br />

Suppository 1250 j.m. +<br />

15000 j..m.<br />

30/04/04<br />

United Vaccines Inc. 27/09/06<br />

Biowet Gorzów 31/12/08<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

Suppository Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

3563 Disulfiram Disulfiramum Implantation tablets 100 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

3564 Dithranol Dithranolum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

3565 Dithranol Dithranolum BUFA b.v. Pharmaceutical<br />

Products<br />

3566 Ditrivet 120 Trimethoprium +<br />

Sulphadiazinum<br />

3567 Ditrivet 480 Trimethoprium +<br />

Sulphadiazinum<br />

Tablet for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/11/05<br />

31/08/06<br />

19/03/07<br />

Biofaktor Sp. z o.o. 18/03/04<br />

Biofaktor Sp. z o.o. 18/03/04<br />

3568 Ditropan Oxybutyninum Tablets 5 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

3569 Diuramid Acetazolamidum Tablets 250 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/06/04<br />

30/10/05<br />

3570 Diurecol Herbal tea Eldex-Medical 2/10/06<br />

3571 Diurecol Instant herbal tea Eldex-Medical 2/10/06<br />

3572 Diuresin Sr Indapamidum Tablets 1,5 mg Polfarmex S.A. 31/12/08<br />

3573 Diuresin Sr Indapamidum Tablets 2,5 mg Polfarmex S.A. 31/12/08<br />

3574 Diureticol-fix Instant herbal tea P.P.H. ‘Eldex-Medical’, Wiry 31/12/08


EN<br />

914 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3575 Diuroflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

3576 Diuronis Preparat ziołowy Liquid Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/03/05<br />

31/12/08<br />

3577 Diurosept fix Instant herbal tea Herbapol — Lublin S.A. 31/12/08<br />

3578 Diurosol Preparat ziołowy Liquid Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

3579 Divascan Iprazochromum Tablets 2.5 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

31/12/08<br />

31/01/05<br />

3580 Diverin Ibuprofenum Gel 50 mg/g (5 %) Lek Pharmaceuticals d.d. 12/10/05<br />

3581 Divigel 0,1 % Estradiolum Gel 0.5 mg/ 0,5 g Orion Corporation 30/11/04<br />

3582 Divigel 0,1 % Estradiolum Gel 1 mg/g Orion Corporation 30/11/04<br />

3583 Divina Estradiolum +<br />

Medroxyprogesteronum<br />

3584 Diviseq Estradiolum +<br />

Medroxyprogesteronum<br />

3585 Dobuject Dobutaminum Concentrate for<br />

solution for<br />

intravenous infusion<br />

3586 Dobutamine Dobutaminum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

3587 Dobutamin-Hexal Dobutaminum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

3588 Dofatrim-Ject Trimethoprium +<br />

Sulphadoxinum<br />

Tablets Orion Corporation 19/03/06<br />

Tablets ORION Corporation 31/12/08<br />

Solution for veterinary<br />

use<br />

50 mg/ml Leiras Oy 31/07/04<br />

250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/06<br />

250 mg Hexal AG 31/01/05<br />

Dopharma B.V. 23/10/06<br />

3589 Dogral Clopidrogrelum Film-coated tablets 75 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

3590 Doksy RW Doxycyclinum Powder for veterinary<br />

use<br />

3591 Doksycyklina 20 % Doxycyclinum Powder for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet Sp. z o.o.<br />

31/12/08<br />

2/01/06<br />

Vetos-Farma 13/10/04<br />

3592 Doksycykliny chlorowodorek Scholz, Sowin 31/01/06<br />

3593 Dolargan Pethidinum Solution for injection 50 mg/ml Chinoin Pharmaceutical and<br />

Chemical Works Co. Ltd.<br />

3594 Dolargan Pethidinum Tablets 25 mg Chinoin Pharmaceutical and<br />

Chemical Works Co. Ltd.<br />

3595 Dolcontral Pethidinum Solution for<br />

subcutaneous,<br />

intramuscular,<br />

intravenous injection<br />

50 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/05/05<br />

31/05/05<br />

30/11/05<br />

3596 Dolgit Ibuprofenum Cream 50 mg/g Dolorgiet Pharmaceuticals 31/12/06<br />

3597 Dolgit Ibuprofenum Gel 50 mg/g Dolorgiet Pharmaceuticals 17/07/06<br />

3598 Dolicoccil 1000 granulki DOLISOS SUISSE 17/08/05<br />

3599 Dolimix bóle pleców Granules Dolisos Laboratoires 9/07/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 915<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3600 Dolimix choroba lokomocyjna Granules Dolisos Laboratoires 9/07/07<br />

3601 Dolimix chrypka Granules Dolisos Laboratoires 9/07/07<br />

3602 Dolimix stomatologiczny Granules Dolisos Laboratoires 9/07/07<br />

3603 Dolimix stres Granules Dolisos Laboratoires 9/07/07<br />

3604 Dolimix tra˛dzik młodzieńczy Granules Dolisos Laboratoires 9/07/07<br />

3605 Dolimix urazy w sporcie Granules Dolisos Laboratoires 9/07/07<br />

3606 Dolimix zapalenie spojówek Granules Dolisos Laboratoires 4/07/07<br />

3607 Dolivaxil Influenzinum 9CH<br />

mikrogranulki<br />

3608 Dolobene Dimethylis sulfoxydum +<br />

Heparinum +<br />

Dexpanthenolum<br />

3609 Dologran Calcii carbonas +<br />

Magnesii carbonas<br />

3610 Dolomit Calcii carbonas +<br />

Magnesii carbonas<br />

3611 Dolomit Calcii carbonas +<br />

Magnesii carbonas<br />

3612 Dolomit — Granulat Calcii carbonas +<br />

Magnesii carbonas<br />

3613 Dolomit o smaku cytrynowym Calcii carbonas +<br />

Magnesii carbonas<br />

3614 Dolomit o smaku cytrynowym Calcii carbonas +<br />

Magnesii carbonas<br />

3615 Dolomit o smaku malinowym Calcii carbonas +<br />

Magnesii carbonas<br />

3616 Dolomit o smaku<br />

pomarańczowym<br />

3617 Dolomit o smaku<br />

pomarańczowym<br />

Calcii carbonas +<br />

Magnesii carbonas<br />

Calcii carbonas +<br />

Magnesii carbonas<br />

3618 Dolores Coffeinum +<br />

Paracetamolum<br />

Dolisos Laboratoires 24/01/07<br />

Gel ratiopharm GmbH 15/11/06<br />

Granules Dolpes SA Przedsie˛biorstwo<br />

Wielobranz˙owe<br />

Tablets VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

Tablets VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

Granules (304mg Ca++,<br />

184mg Mg++)/<br />

5g<br />

31/01/06<br />

31/12/05<br />

31/12/05<br />

Herbapol Łódz´ S.A. 31/01/06<br />

Granules VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

Tablets VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

Katowice<br />

Tablets VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

Katowice<br />

Granules VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

Tablets VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

Katowice<br />

Tablets 50mg +<br />

350mg<br />

3619 Dolores Extra Tablets 500 mg<br />

paracetamol +<br />

1 mg dihydroergotamina<br />

winian<br />

Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

Produkcyjno-Handlowe<br />

Przedsie˛biorstwo<br />

Farmaceutyków CURTIS<br />

HEEALTHCARE Sp. z.o.o.<br />

31/01/05<br />

31/01/05<br />

17/01/07<br />

31/01/05<br />

17/01/07<br />

31/03/07<br />

31/12/08<br />

3620 Dolovit Multimineral Tablets Roche Consumer Health Ltd 31/05/05<br />

3621 Dolovit Natürliche Torula Hefe Tablets Roche Consumer Health Ltd 31/05/04<br />

3622 Dolovit Vitamin A, E+<br />

Spezieller B-Komplex<br />

Coated tablets Roche Consumer Health Ltd 31/05/04


EN<br />

916 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3623 Dolselwit Preparat złoz˙ony Tablets ‘HERBAPOL — ŁÓDZ´ ’ S.A. 31/12/08<br />

3624 Doltard Morphinum Prolonged release<br />

tablets<br />

3625 Doltard Morphinum Prolonged release<br />

tablets<br />

3626 Doltard Morphinum Prolonged release<br />

tablets<br />

3627 Doltard Morphinum Prolonged release<br />

tablets<br />

3628 Domitor Medetomidyny<br />

chlorowodorek<br />

3629 Domosedan Detomidyny<br />

chlorowodorek<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

10 mg Nycomed Danmark A/S 31/12/07<br />

100 mg Nycomed Danmark A/S 31/12/07<br />

30 mg Nycomed Danmark A/S 31/12/07<br />

60 mg Nycomed Danmark A/S 31/12/07<br />

Orion Corporation 16/02/05<br />

Orion Corporation 31/12/08<br />

3630 Donep Donepezilum Film-coated tablets 5 mg, 10 mg GENEXO Sp.z.o.o Warszawa 31/12/08<br />

3631 Donosan Xylometazolinum Nasal spray, solution 0.5 mg/ml ratiopharm GmbH 30/04/04<br />

3632 Dopamin Dopaminum Concentrate for<br />

solution for infusion<br />

3633 Dopamin Solvay 200 Dopaminum Concentrate for<br />

infusions<br />

3634 Dopaminum hydrochloricum<br />

1%<br />

3635 Dopaminum hydrochloricum<br />

4%<br />

Dopaminum Solution for<br />

intravenous infusion<br />

Dopaminum Solution for<br />

intravenous infusion<br />

10 mg/ml Solvay Pharmaceuticals<br />

GmbH<br />

31/07/04<br />

200 mg/10 ml Solvay Pharmaceuticals 31/12/08<br />

10 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

40 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

3636 Dopanol Methyldopum Tablets 250 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

3637 Dopegyt Methyldopum Tablets 250 mg Egis Pharmaceuticals Ltd. 30/06/04<br />

3638 Dopenizil Hydrochloride Donepezilum Film-coated tablets 5 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

3639 Dopenizil Hydrochloride Donepezilum Film-coated tablets 10mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

3640 Doppeldip — płyn Jodofor, alantoina Liquid for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

Avita 31/12/08<br />

3641 Doppelherz Energovital-Tonik Oral solution Queisser Pharma GmbH & Co 30/04/04<br />

3642 Doppelherz Selevit Capsules Queisser Pharma GmbH & Co 31/08/04<br />

3643 Doppelherz Vital Kapseln Capsules Queisser Pharma GmbH & Co 30/04/04<br />

3644 Dopram V Doxapram Solution for veterinary<br />

use<br />

3645 Dorado obroz˙a dla kotów Diazinon Collar for veterinary<br />

use<br />

3646 Dorado obroz˙a dla psów Diazinon Collar for veterinary<br />

use<br />

Fort Dodge 31/12/08<br />

Virbac 25/04/04<br />

Virbac 25/04/04<br />

3652 Dormicum Midazolamum Film-coated tablets 15 mg Egis Pharmaceuticals Ltd. 31/12/06<br />

3653 Dormicum Midazolamum Film-coated tablets 15 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

31/05/04<br />

3654 Dormicum Midazolamum Film-coated tablets 7.5 mg Egis Pharmaceuticals Ltd. 31/12/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 917<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3655 Dormicum Midazolamum Film-coated tablets 7.5 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

31/05/04<br />

3647 Dormicum Midazolamum Injection 15 mg/3 ml Egis Pharmaceuticals Ltd. 31/12/06<br />

3648 Dormicum Midazolamum Injection 5 mg/1 ml Egis Pharmaceuticals Ltd. 31/12/06<br />

3649 Dormicum Midazolamum Solution for injection 1 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

3650 Dormicum Midazolamum Solution for injection 5 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

3651 Dormicum Midazolamum Solution for injection 5 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

3656 Dorminal 20 % pro. inj. Pentobarbital sodu Solution for veterinary<br />

use<br />

3657 Dormiplant Melissae folium<br />

extractum siccum +<br />

Valerianae radix<br />

extractum siccum<br />

31/05/04<br />

31/05/04<br />

30/06/07<br />

Alfasan International 31/12/08<br />

Film-coated tablets Dr. Willmar Schwabe GmbH<br />

& Co.<br />

17/01/07<br />

3658 Dorzopt Dorzolamidum Eye drops 20 mg/ml Merck Sharp & Dohme B.V. 31/12/08<br />

3659 Dosalid 1200 Epsiprantel, Pyrantelu<br />

embonian<br />

3660 Dosalid 300 Epsiprantel, Pyrantelu<br />

embonian<br />

Tablet for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Pfizer 20/06/05<br />

Pfizer 20/06/05<br />

3661 Dosano Doxazosinum Tablets 1 mg Biochemie GmbH 31/12/08<br />

3662 Dosano Doxazosinum Tablets 2 mg Biochemie GmbH 31/12/08<br />

3663 Dosano Doxazosinum Tablets 4 mg Biochemie GmbH 31/12/08<br />

3664 Dostinex Cabergolinum Tablets 0.5 mg Pharmacia & Upjohn S.p.A<br />

(Milano)<br />

30/04/05<br />

3665 Dotur Doxycyclinum Capsules 100 mg Biochemie GmbH — Kundl 30/06/07<br />

3666 Doustna Szczepionka Przeciw<br />

Poliomyelitis<br />

3667 Doustna Szczepionka Przeciw<br />

Poliomyelitis<br />

Vaccinum poliomyelitidis<br />

vivum<br />

Vaccinum poliomyelitidis<br />

vivum<br />

Oral suspension szczepionka 10<br />

— dawkowa<br />

Oral suspension szczepionka 20<br />

— dawkowa<br />

Aventis Pasteur S.A. 31/12/08<br />

Aventis Pasteur S.A. 31/12/08<br />

3668 Doxacard 1 Doxazosinum Tablets 1 mg Cipla Ltd. 31/12/08<br />

3669 Doxacard 2 Doxazosinum Tablets 2 mg Cipla Ltd. 31/12/08<br />

3670 Doxacard 4 Doxazosinum Tablets 4 mg Cipla Ltd. 31/12/08<br />

3671 Doxanorm Doxazosinum Tablets 1 mg ICN Polfa Rzeszów S.A. 23/11/05<br />

3672 Doxanorm Doxazosinum Tablets 2 mg ICN Polfa Rzeszów S.A. 23/11/05<br />

3673 Doxanorm Doxazosinum Tablets 4 mg ICN Polfa Rzeszów S.A. 23/11/05<br />

3674 Doxar Doxazosinum Tablets 2 mg Biovena Pharma Sp z o.o. 30/04/05<br />

3675 Doxar Doxazosinum Tablets 4 mg Biovena Pharma Sp z o.o. 30/04/05<br />

3676 Doxar Doxazosinum Tablets 1 mg Biovena Pharma Sp z o.o. 30/04/05<br />

3677 Doxaratio 1 Doxazosinum Tablets 1 mg ratiopharm GmbH 30/06/05<br />

3678 Doxaratio 2 Doxazosinum Tablets 2 mg ratiopharm GmbH 30/06/05


EN<br />

918 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3679 Doxaratio 4 Doxazosinum Tablets 4 mg ratiopharm GmbH 30/06/05<br />

3680 Doxaratio Xl Doxazosinum Prolonged release<br />

tablets<br />

4 mg ratiopharm GmbH 31/12/08<br />

3681 Doxazosin Doxazosinum Tablets 2 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

3682 Doxazosin Doxazosinum Tablets 1 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

3683 Doxazosin Doxazosinum Tablets 4 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

3684 Doxazosini Doxazosinum Tablets 1 mg ; 2 mg ;<br />

4mg ; 8mg<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

3685 Doxepin Doxepinum Capsules 10 mg Aflofarm 30/10/05<br />

3686 Doxepin Doxepinum Capsules 25 mg Aflofarm 30/10/05<br />

3687 Doxepin Doxepinum Capsules 10 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

3688 Doxepin Doxepinum Capsules 25 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

3689 Doxepin Doxepinum Solution for injection 25 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

3690 Doxepin 10 Doxepinum Capsules 10 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3691 Doxepin 25 Doxepinum Capsules 25 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3692 Doxium Calcii dobesilas Tablets 250 mg OM Pharma (dawniej<br />

Laboratories OM)<br />

3694 Doxolem Doxorubicinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

3693 Doxolem Doxorubicinum Lyophilisate for<br />

solution for injection<br />

3695 Doxolem Doxorubicinum Powder for solution<br />

for intravenous<br />

injection or for slow<br />

intraartey infusion or<br />

for intrabladder use<br />

3696 Doxolem Doxorubicinum Powder for solution<br />

for intravenous<br />

injection or for slow<br />

intraartey infusion or<br />

for intrabladder use<br />

3697 Doxorubicin Doxorubicinum Lyophilisate for<br />

solution for injection<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

28/02/06<br />

28/02/06<br />

31/07/04<br />

10 mg Lemery SA de C.V. 12/10/05<br />

50 mg Lemery SA de C.V. 31/12/04<br />

10 mg Medicom International s.r.o. 31/12/04<br />

50 mg Medicom International s.r.o. 31/12/04<br />

10 mg; 50 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

3698 Doxorubicin — Teva Doxorubicinum Injection 10mg/viol ABIC For Teva Ltd. 31/12/08<br />

3699 Doxorubicin — Teva Doxorubicinum Injection 50mg/viol ABIC For Teva Ltd. 31/12/08<br />

3700 Doxorubicin-Ebewe,<br />

Doxorubicin-Knoll<br />

Doxorubicinum Solution for<br />

intravenous,<br />

intraarterial and<br />

intrabladder infusion<br />

2 mg/ml EBEWE Arzneimittel GmbH 31/08/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 919<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3701 Doxy 150 Doxycyclinum Powder for veterinary<br />

use<br />

Vetimex Animal Health B.V. 15/10/04<br />

3702 Doxycyclin — Stada 100 Doxycyclinum Tablets 100 mg STADApharm GmbH 31/12/08<br />

3703 Doxycyclin — Stada 200 Doxycyclinum Tablets 200 mg STADApharm GmbH 31/12/08<br />

3704 Doxycycline 50 % Doxycyclinum Powder for veterinary<br />

use<br />

3705 Doxycyclinuinum wet. Proszek<br />

20 %<br />

Doxycyclinum Powder for veterinary<br />

use<br />

Dopharmna International B.V. 9/02/06<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

31/12/08<br />

3707 Doxycyclinum Doxycyclinum Capsules, hard 100 mg Farma Projekt Sp. z o.o. 29/08/07<br />

3706 Doxycyclinum Doxycyclinum Capsules 100 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3708 Doxycyclinum Doxycyclinum Solution for<br />

intravenous infusion<br />

3709 Doxycyclinum 20 % Doxycyclinum Powder for veterinary<br />

use<br />

3710 Doxyhyklan 40 Doxycyclinum Powder for veterinary<br />

use<br />

3711 Doxymina 20 % Doxycyclinum Powder for veterinary<br />

use<br />

20 mg/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/10/05<br />

30/10/05<br />

Interbiowet Sp. z o.o. 14/06/05<br />

Lavet Pharmaceuticals Ltd. 23/10/06<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

25/03/07<br />

3712 Doxyratio M Doxycyclinum Tablets 100 mg ratiopharm GmbH 21/06/06<br />

3713 Doxyseptin 100 Doxycyclinum Tablet for veterinary<br />

use<br />

3714 Doxyseptin 300 Doxycyclinum Tablet for veterinary<br />

use<br />

3715 Doxyval 20 % Doxycyclinum Powder for veterinary<br />

use<br />

3716 Doxyveto 50S Doxycyclinum Powder for veterinary<br />

use<br />

3717 Doxyvit 100 soluble powder Chlorowodorek<br />

doksycykliny<br />

3718 Dr theiss coenzym Q10 mit<br />

vitamin E<br />

Powder for veterinary<br />

use<br />

Capsules 15 mg +<br />

13 mg<br />

Vetoquinol S.A. 2/01/06<br />

Vetoquinol S.A. 2/01/06<br />

Sogeval Laboratories 12/03/06<br />

V.M.D. n.v./s.a. 2/01/06<br />

Ceva Sante Animale 31/12/08<br />

NATURWAREN OHG,<br />

Niemcy<br />

31/12/08<br />

3719 Dr theiss schwedenbitter Natur Produkt Sp. z o.o. 31/12/08<br />

3720 Dr Fischer's Bioplus<br />

Vitaltonicum<br />

3721 Dr Fischer's Kinder Bioplus<br />

Aktivtonicum<br />

3722 Dr Reckeweg Cineraria<br />

Maritima krople do oczu<br />

3723 Dr Reckeweg Pulsatilla<br />

compositum krople do nosa<br />

Preparat ziołowy Oral solution Pharmonta; Chem.-Pharm.<br />

Laboratories Mag. pharm. Dr.<br />

Gernot Fischer<br />

Preparat ziołowy Oral solution Pharmonta; Chem.-Pharm.<br />

Laboratories Mag. pharm. Dr.<br />

Gernot Fischer<br />

Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3724 Dr Reckeweg R1 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3725 Dr Reckeweg R10 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

31/07/04<br />

31/07/04<br />

19/12/06<br />

19/12/06<br />

31/12/07<br />

31/12/07


EN<br />

920 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3726 Dr Reckeweg R11 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3727 Dr Reckeweg R12 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3728 Dr Reckeweg R13 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3729 Dr Reckeweg R14 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3730 Dr Reckeweg R16 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3731 Dr Reckeweg R17 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3732 Dr Reckeweg R18 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3733 Dr Reckeweg R19 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3734 Dr Reckeweg R2 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3735 Dr Reckeweg R20 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3736 Dr Reckeweg R21 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3737 Dr Reckeweg R22 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3738 Dr Reckeweg R23 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3739 Dr Reckeweg R24 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3740 Dr Reckeweg R25 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3741 Dr Reckeweg R26 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3742 Dr Reckeweg R27 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3743 Dr Reckeweg R28 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3744 Dr Reckeweg R29 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3745 Dr Reckeweg R3 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3746 Dr Reckeweg R31 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3747 Dr Reckeweg R32 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3748 Dr Reckeweg R33 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3749 Dr Reckeweg R34 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 921<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3750 Dr Reckeweg R35 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3751 Dr Reckeweg R36 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3752 Dr Reckeweg R37 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3753 Dr Reckeweg R38 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3754 Dr Reckeweg R39 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3755 Dr Reckeweg R4 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3756 Dr Reckeweg R40 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3757 Dr Reckeweg R41 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3758 Dr Reckeweg R42 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3759 Dr Reckeweg R43 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3760 Dr Reckeweg R44 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3761 Dr Reckeweg R45 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3762 Dr Reckeweg R46 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3763 Dr Reckeweg R47 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3764 Dr Reckeweg R48 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3765 Dr Reckeweg R49 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3766 Dr Reckeweg R5 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3767 Dr Reckeweg R50 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3768 Dr Reckeweg R51 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3769 Dr Reckeweg R52 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3770 Dr Reckeweg R53 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3771 Dr Reckeweg R54 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3772 Dr Reckeweg R55 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3773 Dr Reckeweg R56 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07


EN<br />

922 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3774 Dr Reckeweg R57 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3775 Dr Reckeweg R58 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3776 Dr Reckeweg R59 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3777 Dr Reckeweg R6 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3778 Dr Reckeweg R60 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3779 Dr Reckeweg R62 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3780 Dr Reckeweg R63 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3781 Dr Reckeweg R64 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3782 Dr Reckeweg R65 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3783 Dr Reckeweg R66 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3784 Dr Reckeweg R67 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3785 Dr Reckeweg R68 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3786 Dr Reckeweg R69 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3787 Dr Reckeweg R7 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3788 Dr Reckeweg R70 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3789 Dr Reckeweg R71 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3790 Dr Reckeweg R72 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3791 Dr Reckeweg R73 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3792 Dr Reckeweg R74 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3793 Dr Reckeweg R75 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3794 Dr Reckeweg R76 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3795 Dr Reckeweg R77 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3796 Dr Reckeweg R78 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3797 Dr Reckeweg R81 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 923<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3798 Dr Reckeweg R82 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3799 Dr Reckeweg R83 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3800 Dr Reckeweg R84 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3801 Dr Reckeweg R85 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3802 Dr Reckeweg R86 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3803 Dr Reckeweg R87 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3804 Dr Reckeweg R88 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3805 Dr Reckeweg R89 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3806 Dr Reckeweg R9 Pharmaceutische Fabrik Dr<br />

Reckeweg<br />

3807 Dr Theiss Echinacea Kräuter<br />

Tropfen<br />

Preparat ziołowy Oral solution Naturwaren OHG Dr Peter<br />

Theiss<br />

3808 Dr Vibs Lotion Preparat ziołowy Coutanous liquid Topchem — Przemysłowo-<br />

Handlowa Sp. z o.o.<br />

3809 Dr. Reckeweg R30 Atomare<br />

Beckeron Mas´ć<br />

3810 Dr. Reckeweg R61 Lumbagin<br />

Mas´ć<br />

3811 Dr. Reckeweg R8 syrop<br />

przeciwkaszlowy — Jutussin<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/05/04<br />

31/12/08<br />

Dr. Reckeweg 30/10/05<br />

Dr. Reckeweg 30/10/05<br />

Dr. Reckeweg 30/10/05<br />

3812 Dr. Reckeweg R91 krople Dr. Reckeweg 30/10/05<br />

3813 Dr. Reckeweg R92 krople Dr. Reckeweg 30/10/05<br />

3814 Dr. Reckeweg R93 krople Dr. Reckeweg 30/10/05<br />

3815 Dr. Reckeweg R94 Płyn do<br />

uz˙ytku zewn.<br />

Dr. Reckeweg 30/10/05<br />

3816 Dr. Reckeweg R95 Płyn Dr. Reckeweg 30/10/05<br />

3817 Dr. Reckeweg Vita-C15 Płyn Dr. Reckeweg 30/10/05<br />

3818 Dr. Reckeweg Vita-C15 forte<br />

Płyn<br />

Dr. Reckeweg 30/10/05<br />

3819 Driptane Oxybutyninum Tablets 5 mg Laboratoires Debat 31/12/08<br />

3820 Dristan Oxymetazolum Nasal spray 15 mg Wyeth — Lederle Pharma<br />

GmbH<br />

3821 Droncit Inj. Praziquantelum Solution for veterinary<br />

use<br />

3822 Droncit Tabl. Praziquantelum Tablet for veterinary<br />

use<br />

3823 Drontal Prazikwantel-<br />

Pyranteluembonian<br />

Tablet for veterinary<br />

use<br />

31/12/08<br />

Bayer AG 31/12/08<br />

Bayer 29/04/04<br />

Bayer AG 7/05/06


EN<br />

924 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3824 Drontal junior Febantel, Pyrantelu<br />

embonian<br />

3825 Drontal Plus Prazikwantel,<br />

Pyrantelu embonian,<br />

Febantel<br />

3826 Drontal Plus XL Prazikwantel, febantel,<br />

embonian pyrantelu<br />

Suspension for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Tablets for veterinary<br />

use<br />

Bayer 25/01/04<br />

Bayer 30/01/05<br />

Bayer 31/12/08<br />

3827 Droperidol Droperidolum Solution for injection 2.5 mg/ml Gedeon Richter Ltd. 31/05/04<br />

3828 Droperteel Tablets Heel GmbH 31/07/05<br />

3829 Drosera complexe nr 64 Drops Lehning Laboratoires 24/08/06<br />

3830 Drosera-Dagomed 2 kaszel DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

3831 Drosera-Homaccord Amp. Heel GmbH 31/12/07<br />

3832 Drosera-Homaccord Drops Heel GmbH 31/12/07<br />

3833 Drosetux syrop Dolisos Laboratoires 31/12/08<br />

3834 Drosol Droserae herbae<br />

extractum siccum<br />

3835 Droxa Ibuprofenum +<br />

Droverinum<br />

3836 Droxef Cefadroxilum Tablets for oral<br />

suspension<br />

3837 Drygen Preparat<br />

radiodiagnostyczny<br />

3838 D-Szczepionka błonicza<br />

adsorbowana na wodorotlenku<br />

glinu<br />

3839 D-Szczepionka błonicza<br />

adsorbowana na wodorotlenku<br />

glinu<br />

3840 d-Szczepionka Przeciw Błonicy<br />

Adsorbowana<br />

D- szczepionka błoniza<br />

adsorbowana<br />

3841 DTaP Szczepionka SSI Diphtheria-tetanuspertussis<br />

Syrup Farmapol 31/12/08<br />

Capsules 200 mg +<br />

20 mg<br />

Solution for<br />

intravenous injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Diphtheria toxoid Suspension for<br />

subcutaneous<br />

injection<br />

Diphtheria toxoid Suspension for<br />

intramuscular<br />

injection<br />

3842 DTaP-IPV Szczepionka SSI Diphtheria-tetanuspertussis<br />

+ Poliomyelitis,<br />

trivalent, inactivated,<br />

whole virus<br />

3843 DTP + Hib — szczepionka Błoniczo-Te˛z˙cowo-<br />

Krztus´cowa adsorbowana, do szczepienia<br />

przypominaja˛cego<br />

3844 DTP + Hib — szczepionka<br />

Błoniczo-Te˛z˙cowo-Krztus´cowa<br />

i rekombinowana szczepionka<br />

przeciw Wizw B<br />

Suspension for<br />

intramuscular<br />

injection<br />

Suspension for<br />

intramuscular<br />

injection<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

1 g Hexal AG 24/05/06<br />

nie mniej niz˙<br />

30 j.m.<br />

toksoidu<br />

błoniczego<br />

nie mniej niz˙<br />

5 j.m. toksoidu<br />

błoniczego<br />

(0,5ml — 1<br />

dawka)<br />

Nycomed Amershan Sorin<br />

S.R.L.<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

25/01/06<br />

31/08/05<br />

31/08/05<br />

1 dawka Chiron Behring GmbH & Co. 12/10/05<br />

Statens Serum Institut 29/02/04<br />

Statens Serum Institut 31/01/05<br />

Suspension Wytwórnia Surowic i<br />

Szczepionek BIOMED<br />

Suspension Wytwórnia Surowic i<br />

Szczepionek BIOMED<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 925<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3845 DTP + Hib — szczepionka<br />

Błoniczo-Te˛z˙cowo-Krztus´cowa<br />

i szczepionka przeciwko Hib<br />

3846 DTP-Szczepionka błoniczote˛z˙cowo-krztus´cowa<br />

adsorbowana<br />

3847 DT-Szczepionka błoniczote˛z˙cowa<br />

adsorbowana<br />

3848 DT-Szczepionka błoniczote˛z˙cowa<br />

adsorbowana<br />

Diphteria toxoid +<br />

tetanus toxoid +<br />

pertussis<br />

Diphtheria toxoid +<br />

tetanus toxoid<br />

Diphtheria toxoid +<br />

tetnus toxoid<br />

3849 Duellin 100/10 Carbidopum +<br />

Levodopum<br />

3850 Duellin 100/25 Carbidopum +<br />

Levodopum<br />

3851 Duellin 250/25 Carbidopum +<br />

Levodopum<br />

Lyophilisate and<br />

suspension<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

nie mniej niz˙<br />

40 j.m.<br />

toksoidu<br />

te˛z˙cowego, nie<br />

mniej niz˙<br />

30 j.m.<br />

toksoidu<br />

błoniczego i<br />

4-12 j.m.<br />

zawiesiny<br />

Bordatella<br />

pertussis<br />

(0,5ml — 1<br />

dawka)<br />

nie mniej niz˙<br />

30j.m.<br />

toksoidu<br />

błoniczego i<br />

nie mniej niz˙<br />

40 j.m.<br />

toksoidu<br />

te˛z˙cowego<br />

(0,5ml — 1<br />

dawka)<br />

nie mniej niz˙<br />

30 j.m.<br />

toksoidu<br />

błonicego i nie<br />

mniej niz˙<br />

40 j.m.<br />

toksoidu<br />

te˛z˙cowego<br />

(10ml — 20<br />

dawek)<br />

Wytwórnia Surowic i<br />

Szczepionek BIOMED<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

31/12/08<br />

31/08/05<br />

30/04/05<br />

31/08/05<br />

Tablets Egis Pharmaceuticals Ltd. 31/01/05<br />

Tablets Egis Pharmaceuticals Ltd. 31/01/05<br />

Tablets Egis Pharmaceuticals Ltd. 31/01/05<br />

3852 Dulcamara-Homaccord Amp. Heel GmbH 31/12/08<br />

3853 Dulcamara-Homaccord Drops Heel GmbH 31/12/08<br />

3854 Dulcolax Docusatum Capsules, soft 50 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

3855 Dultavax Vaccinum diphtheriae et<br />

tetani adsorbatum,<br />

Vaccinum poliomyelitidis<br />

inactivatum<br />

3856 Duo Famotidinum + Calcii<br />

carbonas + Magnesii<br />

hydroxydum<br />

3857 Duo Famotidinum + Calcii<br />

carbonas + Magnesii<br />

hydroxydum<br />

Suspension for<br />

injection<br />

0,5 ml<br />

(szCZpionka 1<br />

— dawkowa)<br />

Buccal tablets preparat<br />

złoz˙ony<br />

Film-coated tablets preparat<br />

złoz˙ony<br />

3858 Duoband Duz˙y Pies Diazinon Collar for veterinary<br />

use<br />

31/12/08<br />

Aventis Pasteur S.A. 31/12/08<br />

US Pharmacia 31/12/08<br />

US Pharmacia 31/12/08<br />

Francodex 31/12/08


EN<br />

926 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3859 Duoband Kot Diazinon Collar for veterinary<br />

use<br />

3860 Duoband Pies Diazinon Collar for veterinary<br />

use<br />

3861 Duocycline 10 Oxytetracyclinum Solution for veterinary<br />

use<br />

Francodex S.A. 21/02/05<br />

Francodex 31/12/08<br />

Univet 10/06/04<br />

3862 Duodenoheel Tablets Heel GmbH 31/12/07<br />

3863 Duodrop Dorzolamidum +<br />

Timololum<br />

3864 Duofilm Acidum lacticum +<br />

Acidum salicylicum<br />

Eye drops (20 mg +<br />

5 mg)/ml<br />

Merck Sharp & Dohme B.V. 31/12/08<br />

Liquid Stiefel Laboratories Ltd. 31/12/08<br />

3865 Duomox Amoxicillinum Tablets 1 g Yamanouchi Europe B.V. 30/04/04<br />

3866 Duomox Amoxicillinum Tablets 125 mg Yamanouchi Europe B.V. 30/04/04<br />

3867 Duomox Amoxicillinum Tablets 250 mg Yamanouchi Europe B.V. 30/04/04<br />

3868 Duomox Amoxicillinum Tablets 375 mg Yamanouchi Europe B.V. 31/01/05<br />

3869 Duomox Amoxicillinum Tablets 500 mg Yamanouchi Europe B.V. 30/04/04<br />

3870 Duomox Amoxicillinum Tablets 750 mg Yamanouchi Europe B.V. 31/01/05<br />

3871 Duo-Septol 120 Sulfamethoxazolum +<br />

Trimethoprimum<br />

3872 Duo-Septol 480 Sulfamethoxazolum +<br />

Trimethoprimum<br />

Tablets 120 mg ICN Polfa Rzeszów S.A. 30/10/05<br />

Tablets 480 mg ICN Polfa Rzeszów S.A. 30/10/05<br />

3873 Duovit Film-coated tablets Krka d.d., Novo mesto 2/11/05<br />

3874 Duowin Contact Permetryna,<br />

Piryproksyfen<br />

3875 Duowin Spray Permetryna,<br />

Piryproksyfen<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Virbac S.A. 2/01/06<br />

Virbac S.A. 2/01/06<br />

3876 Duphalac Lactulosum Syrup 667 mg/ml Solvay Pharmaceuticals B.V. 30/09/04<br />

3877 Duphalac Dry Lactulosum Powder Solvay Pharmaceuticals B.V. 30/04/04<br />

3878 Duphalyte Preparat zawieraja˛cy<br />

elektrolity, witaminy,<br />

aminokwasy i<br />

dekstroze˛.<br />

Solution for veterinary<br />

use<br />

Fort Dodge 28/02/05<br />

3880 Duphaston Dydrogesteronum Film-coated tablets 10 mg Solvay Pharmaceuticals B.V. 8/02/06<br />

3879 Duphaston Dydrogesteronum Tablets 10 mg Solvay Pharmaceuticals B.V. 30/04/04<br />

3881 Duplocillin Benzylpenicillinum<br />

procainicum +<br />

Benzathini benzatylpenicillinum<br />

Suspension for veterinary<br />

use<br />

Intervet 21/05/04<br />

3882 Duracef Cefadroxilum Capsules 500 mg Bristol-Myers Squibb S.p.A,<br />

Latina<br />

3883 Duracef Cefadroxilum Powder for oral<br />

suspension<br />

3884 Duracef Cefadroxilum Powder for oral<br />

suspension<br />

125 mg/5ml Bristol-Myers Squibb S.p.A,<br />

Latina<br />

250 mg/5ml Bristol-Myers Squibb S.p.A,<br />

Latina<br />

30/04/04<br />

30/04/04<br />

30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 927<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3885 Duracef Cefadroxilum Powder for oral<br />

suspension<br />

500 mg/5ml Bristol-Myers Squibb S.p.A,<br />

Latina<br />

3887 Duracef Cefadroxilum Soluble tablets 1 g Bristol-Myers Squibb S.p.A,<br />

Latina<br />

3886 Duracef Cefadroxilum Tablets 1 g Bristol-Myers Squibb S.p.A,<br />

Latina<br />

3888 Duramune CvK Szczepionka przeciw<br />

zakaz˙eniom<br />

koronawirusowym<br />

psów<br />

3889 Duramune Max 10 Szczepionka dla psów<br />

przeciwko nosówce,<br />

zakaz´nemu zapaleniu<br />

wa˛troby, zakaz˙eniu<br />

dróg oddechowych<br />

wywołanym przez<br />

adenowirus typ2 i<br />

wirus parainluenzy<br />

oraz zakaz˙eniom<br />

wywołanym przez<br />

koronawirus i<br />

parwowirus oraz<br />

leptospirozie<br />

wywołanej przez<br />

L. Canicola,<br />

L. Icterohaemorrhagiae,<br />

L. Grippotyphosa i<br />

L. Pomona<br />

3890 Duramune Max 5 Szczepionka dla psów<br />

przeciwko nosówce,<br />

zakaz´nemu zapaleniu<br />

wa˛troby, zakaz˙eniu<br />

dróg oddechowych<br />

wywołanym przez<br />

adenowirus typ2 i<br />

wirus parainluenzy<br />

oraz zakaz˙eniom<br />

wywołanym przez<br />

parwowirus<br />

3891 Duramune Max 6 Szczepionka dla psów<br />

przeciwko nosówce,<br />

zakaz´nemu zapaleniu<br />

wa˛troby, zakaz˙eniu<br />

dróg oddechowych<br />

wywołanym przez<br />

adenowirus typ2 i<br />

wirus parainluenzy<br />

oraz zakaz˙eniom<br />

wywołanym przez<br />

koronawirus i<br />

parwowirus<br />

3892 Duramune Max 9 Szczepionka dla psów<br />

przeciwko nosówce,<br />

zakaz´nemu zapaleniu<br />

wa˛troby, zakaz˙eniu<br />

dróg oddechowych<br />

wywołanym przez<br />

adenowirus typ2 i<br />

wirus parainluenzy<br />

oraz zakaz˙eniom<br />

wywołanym przez<br />

parwowirus oraz<br />

leptospirozie<br />

wywołanej przez<br />

L. Canicola,<br />

L. Icterohaemorrhagiae,<br />

L. Grippotyphosa i<br />

L. Pomona<br />

Liquid for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

30/04/04<br />

31/12/08<br />

30/04/04<br />

Fort Dodge 11/03/04<br />

Fort Dodge 31/12/08<br />

Fort Dodge 31/12/08<br />

Fort Dodge 31/12/08<br />

Fort Dodge 31/12/08


EN<br />

928 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3893 Duramune Puppyshot 5 Szczepionka przeciw<br />

nosówce, zakaz˙eniom<br />

adenowirusowym,<br />

zakaz´nemu zapaleniu<br />

wa˛troby,<br />

parainfluenzie i<br />

parwowirusowej<br />

chorobie psów<br />

3894 Duramune Puppyshot 6 Szczepionka przeciw<br />

nosówce, zakaz˙eniom<br />

adenowirusowym,<br />

koronawirusowym,<br />

zakaz´nemu zapaleniu<br />

wa˛troby,<br />

parainfluenzie i<br />

parwowirusowej<br />

chorobie psów<br />

3895 Duramune Puppyshot 7 Szczepionka przeciw<br />

nosówce, zakaz˙eniom<br />

adenowirusowym,<br />

zakaz´nemu zapaleniu<br />

wa˛troby,<br />

parainfluenzie i<br />

parwowirusowej<br />

chorobie psów oraz<br />

leptospirozie<br />

3896 Duramune Puppyshot 8 Szczepionka przeciw<br />

nosówce, zakaz˙eniom<br />

wywołanym przez<br />

adenowirus typ 2,<br />

zakaz˙eniom<br />

koronawirusowym,<br />

zakaz´nemu zapaleniu<br />

wa˛troby,<br />

parainfluenzie i<br />

parwowirusowej<br />

chorobie psów oraz<br />

leptospirozie<br />

Liquid + lyophilisate for veterinary<br />

use<br />

Liquid + lyophilisate for veterinary<br />

use<br />

Liquid + lyophilisate for veterinary<br />

use<br />

Liquid + lyophilisate for veterinary<br />

use<br />

Fort Dodge 29/09/05<br />

Fort Dodge 11/03/04<br />

Fort Dodge 29/09/05<br />

Fort Dodge 20/07/05<br />

3897 Duraphat Natrii fluoridum Suspension Colgate Palmolive GmbH 31/12/07<br />

3898 Durogesic Fentanylum Transdermal pach 100 mcg/h Janssen Pharmaceutica N.V. 31/12/08<br />

3899 Durogesic Fentanylum Transdermal pach 25 mcg/h Janssen Pharmaceutica N.V. 31/12/08<br />

3900 Durogesic Fentanylum Transdermal pach 50 mcg/h Janssen Pharmaceutica N.V. 31/12/08<br />

3901 Durogesic Fentanylum Transdermal pach 75 mcg/h Janssen Pharmaceutica N.V. 31/12/08<br />

3902 Duspatalin Mebeverinum Film-coated tablets 135 mg Solvay Pharmaceuticals B.V. 25/07/05<br />

3903 Duspatalin Mebeverinum Suspension 10 mg/ml Solvay Pharmaceuticals B.V. 31/05/04<br />

3904 Duspatalin retard Mebeverinum Prolonged release<br />

capsules<br />

200 mg Solvay Pharmaceuticals B.V. 31/12/07<br />

3905 Dygeston Dydrogesteronum Film-coated tablets 10 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

3906 Dynabac Dirithromycinum Film-coated tablets 250 mg Lilly S.A. 31/12/08<br />

3907 Dynamutilin 20 % Inj. Tiamuliny<br />

wodorofumaran<br />

3908 Dynamutilin 45 % Tiamuliny<br />

wodorofumaran<br />

Solution for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Novartis Produkte Inc. 15/10/04<br />

Novartis Animal Health Inc. 31/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 929<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3911 Dynastat Parecoxibum Powder and solvent<br />

for solution for<br />

injection<br />

3912 Dynastat Parecoxibum Powder and solvent<br />

for solution for<br />

injection<br />

3909 Dynastat Parecoxibum Powder for solution<br />

for injection<br />

3910 Dynastat Parecoxibum Powder for solution<br />

for injection<br />

3913 Dyspepsin(pancreosolpoprzednia<br />

nazwa)<br />

3914 Dysport Botulinum toxin typ A Lyophilisate for<br />

solution for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

20 mg Pharmacia Europe EEIG 31/12/08<br />

40 mg Pharmacia Europe EEIG 31/12/08<br />

20 mg Pharmacia Europe EEIG 31/12/08<br />

40 mg Pharmacia Europe EEIG 31/12/08<br />

Oral solution Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

500 j.m. Ipsen Ltd. 30/09/07<br />

3915 Dziegcie sosnowy A.C.E.F., Włochy 31/12/08<br />

3916 Dziegieć sosnowy Pharma Cosmetic, Kraków 14/02/05<br />

3917 Dzień I Noc — na<br />

przezie˛bienie i kaszel<br />

3918 Dzień I Noc — na<br />

przezie˛bienie, gora˛czke˛ i katar<br />

dzień: Paracetamolum +<br />

Pseudoephedrinum +<br />

Dextromethorphanum,<br />

noc: Paracetamolum +<br />

Pseudoephedrinum +<br />

Dextromethorphanum +<br />

Chlorphetaminum<br />

dzień: Paracetamolum +<br />

Pseudoephedrinum, noc:<br />

Paracetamolum +<br />

Pseudoephedrinum +<br />

Chlorphetaminum<br />

Film-coated tablets dzień: 500 mg<br />

+ 30 mg+<br />

15 mg, noc:<br />

500 mg +<br />

30 mg +<br />

15 mg +2 mg<br />

Film-coated tablets dzień: 500 mg<br />

+ 30 mg, noc:<br />

500 mg +<br />

30 mg + 2 mg<br />

Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/12/08<br />

31/12/08<br />

3919 E — Z — CAT Barii sulfas Oral suspension E — Z — EM Inc. 31/12/08<br />

3920 E — Z — HD Barii sulfas Powder E — Z — EM Inc. 31/12/08<br />

3921 E 45 Lanolinum anhydricum<br />

+ Paraffinum liquidum +<br />

Paraffinum solidum<br />

Cream Boots Healthcare<br />

International<br />

31/08/05<br />

3922 EANOX 10 mg Zolpidemum Film-coated tablets 10 mg Desitin Arzneimittel GmbH 31/12/08<br />

3923 EANOX 5 mg Zolpidemum Film-coated tablets 5 mg Desitin Arzneimittel GmbH 31/12/08<br />

3924 Ebrantil 25 Urapidilum Solution for injection 5 mg/ml Altana Pharma AG 30/06/04<br />

3925 Echan Liquid Biocur Arzneimittel GmbH 31/12/08<br />

3926 Echimax Echinaceae purpureae<br />

herba succus<br />

3927 Echimax Echinaceae purpureae<br />

herba succus<br />

3928 Echinacea comp. Płyn w<br />

atomizerze<br />

Oral solution 747 mg/ml ratiopharm GmbH 31/01/05<br />

Tablets 100 mg ratiopharm GmbH 24/08/05<br />

WALA-Heilmittel GmbH 31/08/05<br />

3929 Echinacea Complexe Nr 40 Drops Lehning Laboratoires 31/12/08<br />

3930 Echinacea Compositum Forte<br />

SN<br />

Amp. Heel GmbH 31/12/07


EN<br />

930 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3931 Echinacea Compositum SN Amp. Heel GmbH 31/12/07<br />

3932 Echinacea extra Echinaceae purpureae<br />

succus siccum<br />

Oral drops, solution Dr Theiss Naturwaren GmbH 31/12/08<br />

3933 Echinacea Quarz comp. Eye drops 0,5ml WALA-Heilmittel GmbH 24/05/07<br />

3934 Echinacea ratiopharm Echinaceae angustifolia<br />

radix extractum siccum<br />

3935 Echinacea ratiopharm Echinaceae angustifolia<br />

radix extractum siccum<br />

3936 ECHINACEA/ARGENTUM<br />

ampułki<br />

3937 ECHINACEA/ARGENTUM<br />

granulki<br />

Oral drops, solution 100.5 mg/ml ratiopharm GmbH 29/02/04<br />

Tablets 8 mg ratiopharm GmbH 29/02/04<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 10/03/05<br />

3938 Echinacea/Viscum comp. Gel WALA-Heilmittel GmbH 24/05/07<br />

3939 Echinacin Echinaceae purpureae<br />

herbae succus<br />

3940 Echinacin Echinaceae purpureae<br />

herbae succus<br />

3941 Echinacin Echinaceae purpureae<br />

herbae succus<br />

3942 Echinaforce ® Echinaceae purpureae<br />

herbae et radix extractum<br />

spissum<br />

3944 Echinapur Echinaceae purpureae<br />

herba extractum<br />

3943 Echinapur Echinaceae purpureae<br />

herba extractum<br />

Syrup MADAUS AG 31/12/08<br />

Lozenge MADAUS AG 31/12/08<br />

Oral solution MADAUS AG 31/12/08<br />

Tablets 5,89 mg +<br />

0,31 mg<br />

Bioforce AG 31/12/08<br />

Film-coated tablets 100 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

Ointment 50 mg/g Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

31/08/05<br />

31/08/05<br />

3945 Echinaratio ratiopharm GmbH 31/12/08<br />

3946 Echinasal Syrup Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

3947 Echinatab Echinaceae angustifoliae<br />

radix extractum siccum<br />

3948 Echinrba Echinaceae purpureae<br />

herba extractum siccum<br />

Film-coated tablets 150 mg Medana Pharma TERPOL<br />

Group S.A.<br />

Tablets 100 mg Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

3949 Ecomectin 1 % iwermektyna Solution for veterinary<br />

use<br />

4/12/05<br />

31/12/08<br />

31/12/08<br />

Eco Animal Health Ltd. 31/12/08<br />

3950 Ecomer Omega-3-trójglicerydy Capsules 250 mg Exposan AB 30/04/04<br />

3951 Econor 1 % premix Walnemuliny<br />

chlorowodorek<br />

3952 Econor 10 % premix Walnemuliny<br />

chlorowodorek<br />

3953 Econor 50 % premix Walnemuliny<br />

chlorowodorek<br />

3954 Eczekan Deksametazon,<br />

Nikotynamid,<br />

Pirydoksyny<br />

chlorowodorek, DLmetionina<br />

Premix for veterinary<br />

use<br />

Premix for veterinary<br />

use<br />

Premix for veterinary<br />

use<br />

Medicated candy for veterinary<br />

use<br />

Novartis Animal Health<br />

Austra GmbH<br />

Novartis Animal Health<br />

Austra GmbH<br />

Novartis Animal Health<br />

Austra GmbH<br />

27/06/05<br />

30/06/05<br />

27/06/05<br />

Ceva Sante Animale 30/06/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 931<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3955 Edex 10 Alprostadilum Powder for urethral<br />

injection<br />

3956 Edex 20 Alprostadilum Powder for urethral<br />

injection<br />

3957 Edex 5 Alprostadilum Powder for urethral<br />

injection<br />

3958 Edicin Vancomycinum Powder for solution<br />

for intravenous<br />

injection<br />

3959 Edicin Vancomycinum Powder for solution<br />

for intravenous<br />

injection<br />

10 mcg Schwarz Pharma Sp. z o.o. 31/12/08<br />

20 mcg Schwarz Pharma Sp. z o.o. 31/12/08<br />

5 mcg Schwarz Pharma Sp. z o.o. 31/12/08<br />

500 mg Lek Pharmaceuticals d.d. 31/03/07<br />

1 g Lek Pharmaceuticals d.d. 31/03/07<br />

3960 Ednyt Enalaprili maleas Tablets 10 mg Gedeon Richter Ltd. 31/12/07<br />

3961 Ednyt Enalaprili maleas Tablets 2.5 mg Gedeon Richter Ltd. 31/12/07<br />

3962 Ednyt Enalaprili maleas Tablets 20 mg Gedeon Richter Ltd. 31/12/07<br />

3963 Ednyt Enalaprili maleas Tablets 5 mg Gedeon Richter Ltd. 31/12/07<br />

3964 Edronax Reboxetinum Tablets 4 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

3965 Efamast Capsules Scotia Pharmaceuticals<br />

Limited<br />

3966 Efectin Venlafaxinum Tablets 37.5 mg Wyeth-Lederle Pharma GmbH<br />

Division Whitehall<br />

3967 Efectin Venlafaxinum Tablets 50 mg Wyeth-Lederle Pharma GmbH<br />

Division Whitehall<br />

3968 Efectin Venlafaxinum Tablets 75 mg Wyeth-Lederle Pharma GmbH<br />

Division Whitehall<br />

3969 Efectin ER 150 Venlafaxinum Prolonged release<br />

capsules<br />

12/10/05<br />

31/12/08<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

150 mg Wyeth-Lederle GmbH 30/06/05<br />

3970 Efectin Er 37,5 Venlafaxinum Capsules 37,5 mg Wyeth-Lederle Pharma GmbH 31/12/08<br />

3971 Efectin ER 75 Venlafaxinum Prolonged release<br />

capsules<br />

75 mg Wyeth-Lederle GmbH 30/06/05<br />

3972 Efedryny chlorowodorek Caesar & Loretz GmbH Caelo 31/12/08<br />

3973 Efedryny chlorowodorek Farm-Impex s.j., Gliwice 31/12/08<br />

3974 Efedryny chlorowodorek Pharma Cosmetic, Kraków 31/12/08<br />

3975 Efedryny chlorowodorek Pharma Zentrale 31/12/08<br />

3976 Efedryny chlorowodorek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

3977 Eferox 25 Levothyroxinum<br />

natricum<br />

3978 Eferox 50 Levothyroxinum<br />

natricum<br />

3979 Eferox 75 Levothyroxinum<br />

natricum<br />

3980 Eferox 100 Levothyroxinum<br />

natricum<br />

31/12/08<br />

Film-coated tablets 25 mcg Hexal AG 31/05/04<br />

Film-coated tablets 50 mcg Hexal AG 31/05/04<br />

Film-coated tablets 75 mcg Hexal AG 31/05/04<br />

Film-coated tablets 100 mcg Hexal AG 31/05/04


EN<br />

932 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

3981 Eferox 100 Levothyroxinum<br />

natricum<br />

3982 Eferox 125 Levothyroxinum<br />

natricum<br />

3983 Eferox 125 Levothyroxinum<br />

natricum<br />

3984 Eferox 150 Levothyroxinum<br />

natricum<br />

3985 Eferox 150 Levothyroxinum<br />

natricum<br />

3986 Eferox 25 Levothyroxinum<br />

natricum<br />

3987 Eferox 50 Levothyroxinum<br />

natricum<br />

3988 Eferox 75 Levothyroxinum<br />

natricum<br />

Tablets 100 mcg Hexal AG 31/05/04<br />

Film-coated tablets 125 mcg Hexal AG 31/05/04<br />

Tablets 125 mcg Hexal AG 31/05/04<br />

Film-coated tablets 150 mcg Hexal AG 31/05/04<br />

Tablets 150 mcg Hexal AG 31/05/04<br />

Tablets 25 mcg Hexal AG 31/12/08<br />

Tablets 50 mcg Hexal AG 31/12/08<br />

Tablets 75 mcg Hexal AG 31/12/08<br />

3995 Efferalgan Paracetamolum Effervescent tablets 500 mg UPSA Laboratoires 31/03/04<br />

3993 Efferalgan Paracetamolum Oral solution 30 mg/ml UPSA Laboratoires Agen 24/06/04<br />

3989 Efferalgan Paracetamolum Suppository 150 mg UPSA Laboratoires Agen 30/06/04<br />

3990 Efferalgan Paracetamolum Suppository 300 mg UPSA Laboratoires Agen 30/06/04<br />

3991 Efferalgan Paracetamolum Suppository 600 mg UPSA Laboratoires Agen 30/04/04<br />

3992 Efferalgan Paracetamolum Suppository 80 mg UPSA Laboratoires Agen 31/07/04<br />

3994 Efferalgan Paracetamolum Tablets 500 mg UPSA Laboratoires Agen 31/03/04<br />

3996 Efferalgan Codeine Codeinum +<br />

Paracetamolum<br />

Effervescent tablets UPSA Laboratoires Agen 13/08/06<br />

3997 Efferalgan Forte Paracetamolum Effervescent tablets 1000 mg Laboratoires UPSA 26/09/07<br />

3998 Efferalgan Ssabletki Paracetamolum Buccal tablets 500 mg Laboratoires UPSA 31/12/08<br />

3999 Efferalgan Vitamin C Acidum ascorbicum<br />

(vit C) + Paracetamolum<br />

4000 Effervit calcium Calcii lactogluconas +<br />

Acidum ascorbicum<br />

Effervescent tablets UPSA Laboratoires Agen 31/01/05<br />

Effervescent powder (200mg Ca +<br />

240mg Vit C)/<br />

4g<br />

Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

4001 Effortil Etilefrinum Oral drops 7.5 mg/g Boehringer Ingelheim<br />

International GmbH<br />

4002 Effortil Etilefrinum Tablets 5 mg Boehringer Ingelheim<br />

International GmbH<br />

31/01/06<br />

31/05/04<br />

31/05/04<br />

4003 Effox 10 Isosorbidi mononitras Tablets 10 mg Schwarz Pharma AG 29/06/05<br />

4004 Effox 10 Isosorbidi mononitras Tablets 10 mg Schwarz Pharma Sp. z o.o. 28/08/05<br />

4005 Effox 20 Isosorbidi mononitras Tablets 20 mg Schwarz Pharma AG 30/04/04<br />

4006 Effox 20 Isosorbidi mononitras Tablets 20 mg Schwarz Pharma Sp. z o.o. 28/08/05<br />

4007 Effox 40 Isosorbidi mononitras Tablets 40 mg Schwarz Pharma AG 30/04/04<br />

4008 Effox 40 Isosorbidi mononitras Tablets 40 mg Schwarz Pharma Sp. z o.o. 28/08/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 933<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4009 Effox long Isosorbidi mononitras Prolonged release<br />

capsules<br />

4010 Effox long Isosorbidi mononitras Prolonged release<br />

tablets<br />

4011 Effox long 50 Isosorbidi mononitras Prolonged release<br />

tablets<br />

4012 Effox long 75 Isosorbidi mononitras Prolonged release<br />

tablets<br />

4013 Effydral Sodu chlorekPotasu<br />

chlorekSodu<br />

wodorotlenek-<br />

Bezwodny kwas<br />

cytrynowy-<br />

Jednowodna<br />

lakotzaGlicyna<br />

Effervescent tablet for veterinary<br />

use<br />

4014 Efloran Metronidazolum Solution for<br />

intravenous infusion<br />

50 mg Schwarz Pharma AG 30/04/04<br />

50 mg Schwarz Pharma AG 29/06/05<br />

50 mg Schwarz Pharma Sp. z o.o. 28/08/05<br />

75 mg Schwarz Pharma Sp. z o.o. 30/06/06<br />

Fort Dodge 19/12/06<br />

5 mg/ml Krka d.d., Novo mesto 30/04/04<br />

4015 Efrinol 1 % Ephedrinum Nasal drops, solution 10 mg/g Prolab s.c. — Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Produkcyjno-Analityczno-<br />

Handlowe s.c. Paterek<br />

4016 Efrinol 2 % Ephedrinum Nasal drops, solution 20 mg/g Prolab s.c. — Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Produkcyjno-Analityczno-<br />

Handlowe s.c. Paterek<br />

30/06/05<br />

30/06/05<br />

4017 Efudix Fluorouracilum Ointment 50 mg/g ICN Polfa Rzeszów S.A. 31/01/05<br />

4018 Egilok Metoprololi tartas Tablets 100 mg Egis Pharmaceuticals Ltd. 14/02/07<br />

4019 Egilok Metoprololi tartas Tablets 25 mg Egis Pharmaceuticals Ltd. 14/02/07<br />

4020 Egilok Metoprololi tartas Tablets 50 mg Egis Pharmaceuticals Ltd. 14/02/07<br />

4021 Egilok R Metoprololum Film-coated,<br />

prolonged release<br />

tablets<br />

4022 Egilok R Metoprololum Film-coated,<br />

prolonged release<br />

tablets<br />

4023 Egocin 20 % proszek Oxytetracyclinum Powder for veterinary<br />

use<br />

4024 Egocin LA Oxytetracyclinum Solution for veterinary<br />

use<br />

50 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

100 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

KRKA 31/12/08<br />

KRKA 31/12/08<br />

4025 Eisendragees-ratiopharm Ferrosi sulfas Coated tablets 50 mg Fe++ ratiopharm GmbH 30/01/05<br />

4026 Ekogal Omega-3-trójglicerydy Capsules, soft 300 mg Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

4027 Ekovit Preparat złoz˙ony Tablets Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

4028 Ektifo Bromfenwinfos Solution for veterinary<br />

use<br />

30/10/05<br />

30/10/05<br />

Biowet Puławy Sp. z o.o. 7/04/07<br />

4029 Elagan Capsules Klinge Pharma GmbH 31/12/08


EN<br />

934 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4030 Elancoban 100 Premix Monenzyna sodowa Premix for veterinary<br />

use<br />

Elanco Animal Health 15/03/04<br />

4031 Elatine Cisplatinum Injection 10 mg Eli Lilly 31/12/08<br />

4032 Elektrolitowet Chlorek sodu, Chlorek<br />

potasu, Octan sodu,<br />

Siarczan magnezu,<br />

Glukoza<br />

Solution for veterinary<br />

use<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

4033 Elenium Chlordiazepoxidum Coated tablets 10 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4034 Elenium Chlordiazepoxidum Coated tablets 25 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4035 Elenium Chlordiazepoxidum Coated tablets 5 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4036 Eleuterosol Eleuterococci radicis<br />

extractum fluidum<br />

7/06/04<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

Oral drops Herbapol Lublin S.A. 27/09/06<br />

4037 Eleuterosol Capsules, hard Herbapol — Lublin S.A. 27/09/06<br />

4038 Eleutonin Eleutherococci radix pulv. Capsules, hard 350 mg Phytopharm Kle˛ka S.A. 31/12/08<br />

4039 Elevit Pronatal Film-coated tablets Roche Consumer Health Ltd. 15/11/06<br />

4040 Elidel® Pimecrolimusum Cream 10 mg/g Novartis Pharma AG 31/12/08<br />

4041 Elisol Sód, potas, wapń,<br />

magnez, z˙elazo,<br />

miedz´, cynk, mangan,<br />

jod, kobalt<br />

Liquid for veterinary<br />

use<br />

Biowet Puławy 31/12/08<br />

4042 Elleste 40 Estradiolum Transdermal pach Ethical 31/12/08<br />

4043 Elleste 80 Estradiolum Transdermal pach Ethical 31/12/08<br />

4044 Elmetacin Indometacinum Spray 1 % Sankyo Pharma GmbH —<br />

München<br />

4045 Elmex Gel 12.5 mg<br />

fluoru/g<br />

4046 Elobin Ginkgo bilobae extr.<br />

sicc., Eleutherococci radix<br />

extr. sicc.<br />

Tablets 48 mg +<br />

59 mg<br />

31/12/08<br />

GABA International AG 30/04/04<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

4049 Elocom Mometasonum Coutanous liquid 1 mg/g Schering-Plough Labo N.V. 30/01/05<br />

4047 Elocom Mometasonum Cream 1 mg/g Schering-Plough Labo N.V. 31/05/04<br />

4048 Elocom Mometasonum Ointment 1 mg/g Schering-Plough Labo N.V. 31/05/04<br />

4050 Elosalic Mometasoni furoas,<br />

Acidum salicylicum<br />

Ointment Schering — Plough Central<br />

East S.A.<br />

4051 Elosone Mometasonum Cream 1 mg/g Blau Farma Sp. z o.o. Spółka<br />

Komandytowa<br />

4052 Eltroxin Levothyroxinum<br />

natricum<br />

4053 Eltroxin Levothyroxinum<br />

natricum<br />

4054 Eltroxin Levothyroxinum<br />

natricum<br />

Tablets 100 mcg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Tablets 100 mcg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Tablets 50 mcg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/12/08<br />

6/06/07<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 935<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4055 Eltroxin Levothyroxinum<br />

natricum<br />

4056 Eluat nadtechnecjanu<br />

sodowego 99 mTc otrzymany z<br />

generatora radionuklidowego<br />

99 Mo/ 99 mTc<br />

Preparat<br />

radiodiagnostyczny<br />

4057 Elvenal Valerianae radix<br />

extractum siccum<br />

Tablets 50 mcg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Solution for injection Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

31/12/08<br />

31/12/05<br />

Capsuels, hard 300 mg Biokraft Pharma 30/06/04<br />

4058 Emadine 0,05 % Emedastinum Eye drops, solution 0.5 mg/ml Alcon Laboratoires UK Ltd. 31/05/05<br />

4059 Emeset — 4 Ondansetronum Film-coated tablets 4 mg Cipla Ltd. 31/12/08<br />

4060 Emeset — 8 Ondansetronum Film-coated tablets 8 mg Cipla Ltd. 31/12/08<br />

4061 EMESET 2 ml Ondansetronum Solution for injection 2 mg/ml Cipla Ltd. 31/12/08<br />

4062 EMESET 4 ml Ondansetronum Solution for injection 4 mg/ml Cipla Ltd. 31/12/08<br />

4064 Emetron Ondansetronum Film-coated tablets 4 mg Gedeon Richter Ltd. 11/10/06<br />

4065 Emetron Ondansetronum Film-coated tablets 8 mg Gedeon Richter Ltd. 11/10/06<br />

4063 Emetron Ondansetronum Solution for injection<br />

and intravenous<br />

infusion<br />

4066 EMLA Lidocainum +<br />

Prilocainum<br />

4067 EMLA Lidocainum +<br />

Prilocainum<br />

Cream (25mg +<br />

25mg)/g<br />

Pach (25mg +<br />

25mg)/g<br />

2 mg/ml Gedeon Richter Ltd. 11/10/06<br />

AstraZeneca AB 19/10/05<br />

AstraZeneca AB 31/12/08<br />

4068 Emobina Terbinafinum Gel 10 mg / g Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych ‘EMO’<br />

4069 Emochol Naproxenum Gel 100 mg/g EMO Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych doc dr hab..<br />

Farm. Michał Oginski<br />

4070 Emoclot D.I. Coagulation factor VIII Lyophilisate and<br />

solvent for solution<br />

for injection and<br />

intravascular infusion<br />

4071 Emoclot D.I. Coagulation factor VIII Lyophilisate and<br />

solvent for solution<br />

for injection and<br />

intravascular infusion<br />

4072 Emoclot D.I. Coagulation factor VIII Lyophilisate and<br />

solvent for solution<br />

for injection and<br />

intravascular infusion<br />

4073 Emodiaz Sulfadiazine silver w<br />

ste˛z˙eniu 10 mg/g<br />

4074 Emorect Hippocastani extractum<br />

spissum + Arnicae<br />

tinctura<br />

1000 j.m. Instituto Sierovaccinogeno<br />

Italiana — I.S.I. S.p.A.<br />

250 j.m. Instituto Sierovaccinogeno<br />

Italiana — I.S.I. S.p.A.<br />

500 j.m. Instituto Sierovaccinogeno<br />

Italiana — I.S.I. S.p.A.<br />

Gel 10 mg/g EMO Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych, Ksawerów<br />

k/Łodzi<br />

Gel (40mg +<br />

15mg) /g<br />

EMO Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych doc dr hab.<br />

Farm. Michał Oginski<br />

31/12/08<br />

7/03/07<br />

30/04/05<br />

30/04/05<br />

30/04/05<br />

31/12/08<br />

23/03/05


EN<br />

936 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4075 Emorect Forte Hippocastanum extr,<br />

Arnica extr, Chamomilla<br />

extr, Trannin,<br />

Prilocainum<br />

4076 Emoton® Vitex agni casti fructus<br />

extractum siccum<br />

Gel preparat<br />

złoz˙ony<br />

Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych ‘EMO’<br />

31/12/08<br />

Film-coated tablets 20 mg Tentan AG 31/12/08<br />

4077 Emoxipin Naproxenum Gel 100 mg / g Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych ‘EMO’<br />

31/12/08<br />

4078 Emser Sól Emska Inhalation solution Simens & Co 31/12/08<br />

4079 Emser Sól Emska Nasal spray Simens & Co 31/12/08<br />

4080 Emzok Metoprololum Film-coated,<br />

prolonged release<br />

tablets<br />

4081 Emzok Metoprololum Film-coated,<br />

prolonged release<br />

tablets<br />

4082 Emzok Metoprololum Film-coated,<br />

prolonged release<br />

tablets<br />

4083 Enacard 1 mg Enalaprilu maleinian Tablet for veterinary<br />

use<br />

4084 Enacard 10 mg Enalaprilum Tablet for veterinary<br />

use<br />

4085 Enacard 2,5 mg Enalaprilum Tablet for veterinary<br />

use<br />

4086 Enacard 20 mg Enalaprilum Tablet for veterinary<br />

use<br />

4087 Enacard 5 mg Enalaprilum Tablet for veterinary<br />

use<br />

50 mg IVAX — CR a.s. 31/12/08<br />

100 mg IVAX — CR a.s. 31/12/08<br />

200 mg IVAX — CR a.s. 31/12/08<br />

Merial SAS 31/12/08<br />

Merial SAS 31/12/08<br />

Merial SAS 31/12/08<br />

Merial SAS 31/12/08<br />

Merial SAS 31/12/08<br />

4088 Enalapril Enalaprili maleas Tablets 10 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4089 Enalapril Enalaprili maleas Tablets 5 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

4090 ENALAPRIL — Pane Enalapilum Tablets 5 mg KRKA Polska Sp. z o.o. 31/12/08<br />

4091 ENALAPRIL — Pane Enalapilum Tablets 10 mg KRKA Polska Sp. z o.o. 31/12/08<br />

4092 ENALAPRIL — Pane Enalapilum Tablets 20 mg KRKA Polska Sp. z o.o. 31/12/08<br />

4093 Enalapril — pane Enalaprili maleas Tablets 2,5 mg KRKA Polska Sp. z o.o. 31/12/08<br />

4094 Enap Enalapilum Tablets 2,5 mg KRKA d.d., Novo mesto 26/09/07<br />

4095 Enap Enalaprilatum Injection 1.25 mg/ml Krka d.d., Novo mesto 31/12/08<br />

4096 Enap Enalaprili maleas Tablets 10 mg Krka d.d., Novo mesto 31/07/04<br />

4097 Enap Enalaprili maleas Tablets 20 mg Krka d.d., Novo mesto 31/07/04<br />

4098 Enap Enalaprili maleas Tablets 5 mg Krka d.d., Novo mesto 31/07/04<br />

4099 Enap H Enalaprili maleas +<br />

Hydrochlorothiazidum<br />

Tablets Krka d.d., Novo mesto 31/12/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 937<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4100 Enap HL Enalaprili maleas +<br />

Hydrochlorothiazidum<br />

Tablets Krka d.d., Novo mesto 7/03/07<br />

4101 Enapress Enalaprili maleas Tablets 10 mg P.P.H.U. Biofarm Sp. z o.o. 31/12/08<br />

4102 Enapress Enalaprili maleas Tablets 20 mg P.P.H.U. Biofarm Sp. z o.o. 31/12/08<br />

4103 Enapress Enalaprili maleas Tablets 5 mg P.P.H.U. Biofarm Sp. z o.o. 31/12/08<br />

4104 Enaratio 10 Enalaprili maleas Tablets 10 mg ratiopharm GmbH 5/07/06<br />

4105 Enaratio 20 Enalaprili maleas Tablets 20 mg ratiopharm GmbH 5/07/06<br />

4106 Enaratio 5 Enalaprili maleas Tablets 5 mg ratiopharm GmbH 5/07/06<br />

4107 Enarenal Enalapilum Tablets 2,5 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

4108 Enarenal Enalaprili maleas Tablets 10 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

4109 Enarenal Enalaprili maleas Tablets 20 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

4110 Enarenal Enalaprili maleas Tablets 5 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

4111 Enatec 10 Enalaprili maleas Tablets 10 mg Mepha-Pharma AG 10/05/06<br />

4112 Enatec 20 Enalaprili maleas Tablets 20 mg Mepha-Pharma AG 10/05/06<br />

4113 Enatec 5 Enalaprili maleas Tablets 5 mg Mepha-Pharma AG 10/05/06<br />

4114 Enazil 10 Enalapilum Tablets 10 mg PLIVA — Lachema a.s. 31/12/08<br />

4115 Enazil 20 Enalapilum Tablets 20 mg PLIVA — Lachema a.s. 31/12/08<br />

4116 Enazil 5 Enalapilum Tablets 5 mg PLIVA — Lachema a.s. 31/12/08<br />

4117 Enbrel Etanerceptum Powder and solvent<br />

for solution for<br />

injection<br />

4118 Encefal-Vac Z˙ywa szczepionka dla<br />

kur przeciw<br />

zakaz´nemu zapaleniu<br />

mózgu i rdzenia<br />

kre˛gowego ptaków<br />

4119 Encepur Adults Encephalitis, tick borne<br />

immunoglobulin<br />

4120 Encepur K Encephalitis, tick borne<br />

immunoglobulin<br />

Lyophilisate for veterinary<br />

use<br />

Suspension for<br />

intramuscular<br />

injection<br />

Suspension for<br />

intramuscular<br />

injection<br />

4121 Encopirin Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

4122 Encopirin Cardio Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

4123 Encopirin Cardio 81 Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

25 mg Wyeth-Lederle GmbH 9/08/06<br />

1.5 mcg<br />

FSME-virus<br />

0.75 mg/<br />

0,25 ml<br />

FATRO S.p.A. 19/02/06<br />

Chiron Behring GmbH & Co. 31/12/08<br />

Chiron Behring GmbH & Co. 21/03/07<br />

325 mg Perrigo Company 31/03/07<br />

81 mg Kato Laboratories Inc. 31/12/08<br />

81 mg Omega Rex s.c. 9/08/06<br />

4124 Encortolon Prednisolonum Tablets 5 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05


EN<br />

938 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4125 Encorton Prednisonum Tablets 1 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

4126 Encorton Prednisonum Tablets 10 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

4127 Encorton Prednisonum Tablets 20 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

4128 Encorton Prednisonum Tablets 5 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

4129 Endivac Szczepionka dla norek<br />

przeciw zakaz´nemu<br />

zapaleniu jelit<br />

4130 Endobulin Immunoglobulinum<br />

humanum<br />

4131 Endofer Kompleks dekstranu i<br />

z˙elaza<br />

4132 Endofer 20 Kompleks dekstranu i<br />

z˙elaza<br />

4133 Endopar PF Prazikwantel,<br />

Fenbendazol<br />

4134 Endopar Plus Prazikwantel,<br />

Pyrantelu embonian,<br />

Oksantelu embonian<br />

4135 Endopar PP Prazikwantel,<br />

embonian pyrantelu<br />

4136 Endopar PPO Prazikwantel, pyrantel,<br />

oksantel<br />

Suspension for veterinary<br />

use<br />

Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

infusion<br />

50 mg/ml<br />

immunoglobuliny<br />

G<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Paste for veterinary<br />

use<br />

Tablets for veterinary<br />

use<br />

4137 Endoparin Praziquantelum Solution for veterinary<br />

use<br />

31/12/05<br />

30/10/05<br />

30/10/05<br />

31/12/05<br />

United Vaccines Inc. 15/05/06<br />

Baxter AG 31/03/04<br />

Fatro 25/08/05<br />

Fatro 25/08/05<br />

HeinzHaupt 31/12/08<br />

Bomac Lab. 31/12/08<br />

Bomac 31/12/08<br />

Bomac 31/12/08<br />

aniMedica West 31/12/08<br />

4138 Endopril 10 Enalapilum Tablets 10 mg Polfarmex S.A. 31/12/08<br />

4139 Endopril 20 Enalapilum Tablets 20 mg Polfarmex S.A. 31/12/08<br />

4140 Endopril 5 Enalapilum Tablets 5 mg Polfarmex S.A. 31/12/08<br />

4141 Endosal Dinatrii edetas Liquid 150 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

4142 Endotelon Oligomery procyjanidowe Film-coated,<br />

gastro-resistant tablets<br />

30/10/05<br />

150 mg Sanofi-Synthelabo France 31/03/07<br />

4143 Endoxan — Asta Cyclophosphamidum Coated tablets 50 mg Asta Medica AG 31/07/04<br />

4145 Endoxan — Asta Cyclophosphamidum Powder for solution<br />

for injection<br />

4144 Endoxan — Asta Cyclophosphamidum Powder for solution<br />

for intravenous<br />

infusion<br />

4146 Enema Natrii phosphas + Natrii<br />

phosphas (32P)<br />

Solution for rectal<br />

infusion<br />

200 mg Asta Medica AG 31/07/04<br />

1 g Asta Medica AG 31/07/04<br />

R & C — Przedsie˛biorstwo<br />

Farmaceutyczne s.c.<br />

4147 Enerbol 100 Pyritinolum Coated tablets 0.1 g Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/01/06<br />

30/11/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 939<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4148 Enerbol 200 Pyritinolum Film-coated tablets 200 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4149 Enflocyna Inj. Enrofloxacinum Solution for veterinary<br />

use<br />

4150 Enflocyna sol. Enrofloxacinum Solution for veterinary<br />

use<br />

4151 Engemycin 10 % Oxytetracyclinum Solution for veterinary<br />

use<br />

4152 ENGERIX B Hepatitis B, purified<br />

antigen<br />

4153 ENGERIX B Hepatitis B, purified<br />

antigen<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

30/11/05<br />

Biowet Puławy 19/05/04<br />

Biowet Puławy 19/05/04<br />

Intervet 11/03/04<br />

10 mcg/0,5 ml SmithKline Beecham<br />

Biologicals<br />

20 mcg/1 ml SmithKline Beecham<br />

Biologicals<br />

29/02/04<br />

29/02/04<br />

4154 Engystol N Amp. Heel GmbH 31/12/07<br />

4155 Enhancin (Ramoclav) Amoxicillinum +<br />

Acidum clavulanicum<br />

4156 Enhancin (Ramoclav) Amoxicillinum +<br />

Acidum clavulanicum<br />

Powder for oral<br />

suspension<br />

Powder for oral<br />

suspension<br />

(125 mg+<br />

31,25 mg)/<br />

5ml<br />

(250 mg+<br />

62,5 mg)/ 5 ml<br />

Ranbaxy Laboratoires Ltd. 31/12/08<br />

Ranbaxy Laboratoires Ltd. 31/12/08<br />

4157 Enkosaparyna Enoxaparinum Amp-syringe 40 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

4158 Enkosaparyna Enoxaparinum Amp-syringe 60 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

4159 Enkosaparyna Enoxaparinum Amp-syringe 80 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

4160 Enoksaparyna Enoxaparinum Amp-syringe 20 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

4161 Enrich (o smaku waniliowym) Preparat odz˙ywczy Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

4162 Enrich Plus (o smaku<br />

malinowym)<br />

4163 Enrich Plus (o smaku<br />

waniliowym)<br />

Preparat odz˙ywczy Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

Preparat odz˙ywczy Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

4164 Enrobioflox 10 % Enrofloxacinum Solution for veterinary<br />

use<br />

4165 Enrobioflox 5 % Injectio Enrofloxacinum Solution for veterinary<br />

use<br />

4166 Enrobioflox 50 mg tabletki Enrofloxacinum Tablet for veterinary<br />

use<br />

4167 Enrocin 10 % oral Enrofloxacinum Solution for veterinary<br />

use<br />

4168 Enrocin 5 % inj. Enrofloxacinum Solution for veterinary<br />

use<br />

4169 Enrofloksacyna 10 % Enrofloxacinum Solution for veterinary<br />

use<br />

4170 Enrofloksacyna 10 % inj. Enrofloxacinum Solution for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Zakłady Farmaceutyczne<br />

‘Biowet’ Sp. z o.o<br />

Zakłady Farmaceutyczne<br />

Biowet Sp. z o.o.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

14/03/06<br />

10/05/06<br />

10/05/06<br />

16/01/05<br />

14/08/05<br />

14/06/05<br />

Vet-Agro Sp. z o.o. 31/12/08<br />

Vet-Agro 31/12/08<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

8/09/05<br />

8/09/05


EN<br />

940 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4171 Enrofloksacyna 10 % Płyn Enrofloxacinum Liquid for veterinary<br />

use<br />

4172 Enrofloxacyna 10 % iniekcja Enrofloxacinum Solution for veterinary<br />

use<br />

4173 Enrofloxacyna 5 % iniekcja Enrofloxacinum Solution for veterinary<br />

use<br />

4174 Enrofloxan 10 % Enrofloxacinum Solution for veterinary<br />

use<br />

4175 Enroxil 10 % Enrofloxacinum Solution for veterinary<br />

use<br />

4176 Enroxil 10 % Oral Enrofloxacinum Solution for veterinary<br />

use<br />

4177 Enroxil 15 Enrofloxacinum Tablet for veterinary<br />

use<br />

4178 Enroxil 150 Enrofloxacinum Tablet for veterinary<br />

use<br />

4179 Enroxil 2,5 % Enrofloxacinum Liquid for veterinary<br />

use<br />

4180 Enroxil 5 % Enrofloxacinum Solution for veterinary<br />

use<br />

Vetos-Farma 31/12/08<br />

Vetos-Farma 31/12/08<br />

Vetos-Farma 31/12/08<br />

Felix Pharma 31/12/08<br />

KRKA 4/12/06<br />

KRKA 31/12/08<br />

KRKA 14/06/05<br />

KRKA 14/06/05<br />

KRKA 31/12/08<br />

KRKA 4/12/06<br />

4181 Ensure (o smaku waniliowym) Preparat odz˙ywczy Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

4182 Ensure (o smaku waniliowym) Preparat odz˙ywczy Powder Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

4183 Ensure Plus Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

4184 Ensure Plus (o smaku<br />

waniliowym)<br />

Preparat odz˙ywczy Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

4185 Ensure Plus HN Preparat odz˙ywczy Liquid Ross Products Division -<br />

Abbott Laboratories<br />

4186 Ensure Plus HN (o smaku<br />

waniliowym)<br />

4187 Ensure Plus HN (o smaku<br />

bananowym)<br />

4188 Ensure Plus HN (o smaku<br />

czekoladowym)<br />

4189 Ensure Plus HN (o smaku<br />

czekoladowym)<br />

4190 Ensure Plus HN (o smaku<br />

owoców les´nych)<br />

4191 Ensure Plus HN (o smaku<br />

waniliowym)<br />

4192 Enteramid Sulfaguanidyna,<br />

Sulfadymidyna,<br />

Formosulfatiazol<br />

4193 Enteroferment Stabilizowane<br />

drobnoustroje<br />

Lactobacillus sp.<br />

Preparat odz˙ywczy Liquid Ross Products Division -<br />

Abbott Laboratories<br />

Preparat odz˙ywczy Oral solution Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

Preparat odz˙ywczy Liquid Ross Products Division -<br />

Abbott Laboratories<br />

Preparat odz˙ywczy Oral solution Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

Preparat odz˙ywczy Oral solution Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

Preparat odz˙ywczy Oral solution Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

Tablet for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

14/03/06<br />

30/06/07<br />

31/12/08<br />

14/03/06<br />

29/03/06<br />

29/03/06<br />

25/05/05<br />

29/03/06<br />

29/03/06<br />

25/05/05<br />

25/05/05<br />

Biowet Puławy 24/05/04<br />

Richter Pharma 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 941<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4194 Enterogast Neomycyny siarczan,<br />

Sulfaguanidyna<br />

Granules for veterinary<br />

use<br />

ZakładyFarmaceutyczne<br />

Biowet<br />

30/06/04<br />

4195 Enterol 250 Saccharomyces boulardii Capsules 250 mg Laboratoires Biocodex 31/12/08<br />

4196 Enterol 250 Saccharomyces boulardii Powder 250 mg Laboratoires Biocodex 31/12/08<br />

4197 Enterosol Preparat ziołowy Oral solution Phytopharm Kle˛ka S.A. 31/08/05<br />

4198 Entocort Budesonidum Prolonged release<br />

capsules, hard<br />

3 mg AstraZeneca AB 31/08/04<br />

4199 Entreik Acidum acetylsalicylicum Film-coated tablets 325 mg LNK International Inc. 31/12/08<br />

4200 Entreik 81 Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

81 mg LNK International Inc. 31/03/07<br />

4201 Envit Q10 Ubidecarenonum Granules 30 mg/g Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

4202 Envit Q10 Ubidecarenonum Tablets 30 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

4203 Envit Q10 Plus Ubidecarenonum Capsules 30 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4204 Enzaprost F 5 Dinoprostum Solution for injection 5 mg/1 ml Chinoin Pharmaceutical and<br />

Chemical Works Co. Ltd.<br />

31/07/05<br />

31/07/05<br />

31/12/08<br />

30/06/04<br />

4205 Enzian Liquid WALA-Heilmittel GmbH 24/05/07<br />

4206 Epanutin Parenteral Phenytoinum Solution for injection 50 mg/ml Parke Davis GmbH 31/07/04<br />

4207 Epasel Capsules 0.5 g Pharmarex Development and<br />

Trade Ltd.<br />

4208 Ephedrinum hydrochloricum Ephedrinum Solution for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

25 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/04/04<br />

22/02/06<br />

4209 Epilam Lamotriginum Tablets 25 mg GENEXO Sp.z.o.o Warszawa 31/12/08<br />

4210 Epilam Lamotriginum Tablets 50 mg GENEXO Sp.z.o.o Warszawa 31/12/08<br />

4211 Epilam Lamotriginum Tablets 100 mg GENEXO Sp.z.o.o Warszawa 31/12/08<br />

4212 Epilam 100 Lamotriginum Tablets 100 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4213 Epilam 25 Lamotriginum Tablets 25 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4214 Epilam 50 Lamotriginum Tablets 50 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

4215 EPIPHYSIS/PLUMBUM ampułki WALA-Heilmittel GmbH 19/03/05<br />

4216 EPIPHYSIS/PLUMBUM granulki WALA-Heilmittel GmbH 19/03/05<br />

4217 Epistabil Lamotriginum Tablets 25 mg Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp. z<br />

o.o.<br />

4218 Epistabil Lamotriginum Tablets 50 mg Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp. z<br />

o.o.<br />

4219 Epistabil Lamotriginum Tablets 100 mg Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp. z<br />

o.o.<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

942 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4220 Epogam Capsules Scotia Pharmaceuticals<br />

Limited<br />

4221 Epoglobin Epoetinum alfa Solution for injection 2000 j.m./ml Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

4222 Epoglobin Epoetinum alfa Solution for injection 4000 j.m./ml Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

4224 Epomax Epoetinum omega Solution for<br />

subcutaneous and<br />

intravascular injection<br />

4223 Epomax Epoetinum omega Solution for<br />

subcutaneous and<br />

intravenous injection<br />

4225 Epox Erythropoetinum Solution for<br />

intravenous and<br />

subcutanous injection<br />

4226 Eprex Epoetinum alfa Solution for<br />

intravenous and<br />

subcutaneous<br />

injection<br />

4<strong>227</strong> Eprex Erythropoietinum Solution for<br />

intravenous or<br />

subcutaneous<br />

injection<br />

4228 Eprex Erythropoietinum Solution for<br />

intravenous or<br />

subcutaneous<br />

injection<br />

4229 Eprex Erythropoietinum Solution for<br />

intravenous or<br />

subcutaneous<br />

injection<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

4000 j.m./1 ml Fumedica Biopol Sp. z o.o. 31/12/08<br />

2000 j.m./1 ml Fumedica Biopol Sp. z o.o. 31/12/08<br />

1000 j.m./<br />

0,5ml,<br />

2000 j.m./<br />

0,5ml,<br />

2000 j.m./ml,<br />

3000 j.m./<br />

0,3ml,<br />

4000 j.m./<br />

0,4ml,<br />

4000 j.m./ml,<br />

10 000 j.m./ml<br />

20000 j.m./<br />

0,5 ml;<br />

40000 j.m./ml<br />

GENEXO Sp.z.o.o Warszawa 31/12/08<br />

Cilag AG 30/01/05<br />

10000 j.m./ml Cilag AG 30/01/05<br />

2000 j.m./ml Cilag AG 30/01/05<br />

4000 j.m./ml Cilag AG 30/01/05<br />

4230 Epril 10 Enalaprili maleas Tablets 10 mg Hexal AG 11/10/06<br />

4231 Epril 2,5 Enalaprili maleas Tablets 2.5 mg Hexal AG 17/01/07<br />

4232 Epril 20 Enalaprili maleas Tablets 20 mg Hexal AG 11/10/06<br />

4233 Epril 5 Enalaprili maleas Tablets 5 mg Hexal AG 11/10/06<br />

4234 Eprinex Pour-On Eprinomektyna Solution for veterinary<br />

use<br />

4235 Equalan Iwermektyna Paste for veterinary<br />

use<br />

4236 Equantel Pyrantelu embonian Paste for veterinary<br />

use<br />

4237 Equest 2 % Oral Gel Moksydektyna Gel for veterinary<br />

use<br />

Merial 27/03/05<br />

Merial 31/12/08<br />

Bimeda 31/12/08<br />

Fort Dodge Veterinaria S.A. 30/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 943<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4238 Equiffa Inaktywowana<br />

szczepionka dla koni<br />

przeciw grypie i<br />

wirusowemu ronieniu<br />

klaczy<br />

4239 Equigrip Szczepionka przeciw<br />

grypie koni<br />

4240 Equilis Equenza T Inaktywowana<br />

szczepionka dla koni<br />

przeciwko influenzie<br />

koni i te˛z˙cowi<br />

4241 Equilis Resequin NN Plus szczepionka do<br />

czynnego<br />

uodparniania koni i<br />

kuców przed<br />

klinicznymi objawami<br />

infekcji układu<br />

oddechowego<br />

4242 Equimax Iwermektyna,<br />

Prazikwantel<br />

4243 Equipar iwermektyna,<br />

prazikwantel<br />

Emulsion for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Paste for veterinary<br />

use<br />

Paste for veterinary<br />

use<br />

Merial SAS 2/04/06<br />

Merial 14/06/04<br />

Intervet International B.V. 18/09/07<br />

Intervet International 31/12/08<br />

Virbac do Brasil 8/05/06<br />

Bomac 31/12/08<br />

4244 Equoral Ciclosporinum Gelatin capsules, soft 100 mg IVAX-CT a.s. 27/06/07<br />

4245 Equoral Ciclosporinum Gelatin capsules, soft 25 mg IVAX-CT a.s. 27/06/07<br />

4246 Equoral Ciclosporinum Gelatin capsules, soft 50 mg IVAX-CT a.s. 27/06/07<br />

4247 Equoral Ciclosporinum Oral solution 100 mg/ml IVAX-CT a.s. 27/06/07<br />

4248 ER BAC PLUS inaktywowana<br />

szczepionka dla<br />

s´wińprzeciwko róz˙ycy<br />

Suspension for veterinary<br />

use<br />

Pfizer 31/12/08<br />

4249 Ercefuryl Nifuroxazidum Capsules 200 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

4250 Ercefuryl Nifuroxazidum Oral suspension 218 mg/5 ml Synthelabo Group.<br />

Laboratoires Synthelabo<br />

4251 Eres bromoheksyna Solution for veterinary<br />

use<br />

31/01/05<br />

31/01/05<br />

Laboratiorios Calier SA 31/12/08<br />

4252 Erexan Sildenafilum Film-coated tablets 100 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4253 Erexan Sildenafilum Film-coated tablets 50 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4254 Erexan Sildenafilum Film-coated tablets 25 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4255 Ergo Mildronatum Capsules 250 mg Public Joint Stock Company<br />

‘Grindex’<br />

4256 Ergolaktyna Bromocriptinum Tablets 2.5 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

4257 Ergotaminum tartaricum Ergotaminum Coated tablets 1 mg Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’, Bydgoszcz<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/09/05<br />

31/01/06<br />

4258 Erigotheel Amp. Heel GmbH 31/12/08<br />

4259 Erka Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Ethoxybenzamidum<br />

Tablets 300mg +<br />

50mg +<br />

100mg<br />

AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

21/03/07


EN<br />

944 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4260 Ervevax Rubella, live attenuated Lyophilisate for<br />

solution for injection<br />

4261 Ervevax Rubella, live attenuated Lyophilisate for<br />

solution for injection<br />

1 dawka SmithKline Beecham<br />

Biologicals<br />

10 dawek SmithKline Beecham<br />

Biologicals<br />

29/02/04<br />

29/02/04<br />

4262 Erysidoron 1 krople WELEDA 24/08/05<br />

4263 Erysidoron 2 tabletki WELEDA 24/08/05<br />

4264 Erysorb Parvo Szczepionka dla s´wiń<br />

przeciwko róz˙ycy I<br />

parwowirozie s´wiń<br />

Suspension for veterinary<br />

use<br />

Hoechst Russel 31/12/08<br />

4265 Erythrin Z˙el Erythromycinum Gel 20 mg / g Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych ‘EMO’<br />

4268 Erythromycinum Erythromycinum Film-coated tablets 200 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4266 Erythromycinum Erythromycinum Granules for oral<br />

solution<br />

4267 Erythromycinum Erythromycinum Granules for oral<br />

solution<br />

4269 Erythromycinum Intravenosum Erythromycinum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

4270 Erythromycinum pro<br />

suspensione<br />

Erythromycinum Granules for oral<br />

solution<br />

125 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

300 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

125 mg/5ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4271 Erytromycyna Erythromycinum BUFA b.v. Pharmaceutical<br />

Products<br />

4272 Erytromycyna Erythromycinum Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

31/05/06<br />

31/05/06<br />

4273 Erytromycyna Erythromycinum Pharma Cosmetic, Kraków 31/05/06<br />

4274 Erytromycyna Erythromycinum Pharma Zentrale 31/05/06<br />

4275 Erytromycyna Erythromycinum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

4276 Erytrowet Erytromycyny rodanek Powder for veterinary<br />

use<br />

4277 Erytrowet granulat 20 % Rodanek etyromycyny Granules for veterinary<br />

use<br />

4278 Esafosfina Fructosi — 1,6 —<br />

diphosphas<br />

4279 Esafosfina 0,5 Fructosi — 1,6 —<br />

diphosphas<br />

4280 Esafosfina 5,0 Fructosi — 1,6 —<br />

diphosphas<br />

4281 ESB 3 Sulfaklozyny sól<br />

sodowa<br />

4282 Esbericum Hyperici herbae<br />

extractum siccum<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

31/05/06<br />

10/05/04<br />

31/12/08<br />

Solution for infusion 100 ml Biomedica Foscama S.p.A. 31/12/08<br />

Lyophlisated powder 0,5 g Biomedica Foscama S.p.A. 31/12/08<br />

Lyophlisated powder 5,0 g Biomedica Foscama S.p.A. 31/12/08<br />

Powder for veterinary<br />

use<br />

Novartis Produkte Inc. 10/02/04<br />

Capsules, hard 71,0-84,0 mg Scharper & Brümmer GmbH<br />

& Co.KG<br />

4283 Esberitox N Oral solution Schaper & Brümmer GmbH<br />

& Co. KG<br />

31/12/08<br />

29/02/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 945<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4284 Esberitox N Tablets Schaper & Brümmer GmbH<br />

& Co. KG<br />

4285 Escalar Preparat ziołowy Ointment Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

4286 Esceven Hippocastani semen<br />

extractum siccum<br />

4287 Esceven Hippocastani semen<br />

extractum siccum +<br />

Heparinum<br />

4288 Esceven Hippocastani semen<br />

extractum spissum<br />

Film-coated tablets 167 mg Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

Gel for external use (83,5mg +<br />

50 j.m.)/g<br />

4289 Esmeron Rocuronii bromidum Intravenous injection<br />

(solution)<br />

4290 Esmeron Rocuronii bromidum Intravenous injection<br />

(solution)<br />

Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

Film-coated tablets 2.5 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

29/02/04<br />

31/12/08<br />

31/08/05<br />

31/08/05<br />

31/08/05<br />

0.1 g/10 ml Organon N.V. 31/12/08<br />

50 mg/5 ml Organon N.V. 31/12/08<br />

4291 Espa — Dorm Zopliconum Film-coated tablets 7,5 µg Esparma GmbH 31/12/08<br />

4292 ESPA — LEPSIN 200 Retard Carbamazepinum Prolonged release<br />

tablets<br />

4293 ESPA — LEPSIN 400 Retard Carbamazepinum Prolonged release<br />

tablets<br />

200 mg Esparma GmbH 31/12/08<br />

400 mg Esparma GmbH 31/12/08<br />

4294 Esperal Disulfiramum Implantatation tablets 100 mg Sanofi Winthrop-Gentilly<br />

Cedex<br />

4295 Espes Benzylpenicillinum<br />

procainicum +<br />

Dihydrostreptomycinum<br />

4296 Espumil Dimeticonum Granules for<br />

oromucosal use<br />

Suspension for veterinary<br />

use<br />

30/06/04<br />

Laboratiorios Calier SA 31/12/08<br />

60 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4297 Espumisan Dimeticonum Capsules 40 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

4298 Espumisan Simeticonum Oral drops 40 mg/ml BERLIN — CHEMIE AG<br />

(Menarini Group)<br />

4299 Espumisan 40 Simeticonum Emulsion 40 mg/5 ml Berlin-Chemie AG (Menarini<br />

Group)<br />

4301 Esputicon Dimeticonum Capsules 50 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

4302 Esputicon Dimeticonum Drops 20 mg/1<br />

krople˛<br />

Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

4300 Esputicon Dimeticonum Oral granules 150 mg/5g Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

4303 Esseliv Phospholipidum<br />

essentiale<br />

4304 Essentiale Phospholipidum<br />

essentiale<br />

4305 Essentiale forte Phospholipidum<br />

essentiale<br />

Capsuels, hard 300 mg AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

Solution for injection 50 mg/ml Rhone-Poulenc Rorer A.<br />

Natterman & Cie.GmbH<br />

Capsules 300 mg Rhone-Poulenc Rorer A.<br />

Natterman & Cie.GmbH<br />

31/01/05<br />

30/06/04<br />

30/06/04<br />

31/12/07<br />

31/05/05<br />

22/11/06<br />

31/05/05<br />

25/04/07<br />

31/07/04<br />

31/07/04


EN<br />

946 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4306 Essentiale forte Phospholipidum<br />

essentiale<br />

Capsules 300 mg Rhône-Poulenc Rorer Sp. z<br />

o.o.<br />

31/01/06<br />

4307 Essiac Herbal tea Essiac Products Inc. 31/12/08<br />

4308 Estalis Estradiolum +<br />

Norethisteronum<br />

4309 Estalis Estradiolum +<br />

Norethisteronum<br />

4310 Estalis Sequi Estradiolum +<br />

Norethisteronum<br />

Transdermal patch Novartis Pharma AG 31/07/05<br />

Transdermal patch Novartis Pharma AG 31/07/05<br />

Transdermal patch Novartis Pharma AG 31/07/05<br />

4311 Estazolam Estazolamum Tablets 2 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/05<br />

4312 Estazolam Estazolamum Tablets 2 mg Aflofarm 31/12/05<br />

4313 Estazolam Estazolamum Tablets 2 mg Polfarmex S.A. 31/12/05<br />

4314 Estracomb TTS Estradiolum +<br />

Norethisteronum<br />

Transdermal patch Novartis Pharma AG 30/01/05<br />

4315 Estracyt Estramustinum Capsules 140 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

4316 Estracyt Estramustinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

300 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

31/05/04<br />

31/05/04<br />

4317 Estraderm MX 25 Estradiolum Transdermal patch 25 mcg/24 h Novartis Pharma AG 31/03/07<br />

4318 Estraderm MX 50 Estradiolum Transdermal patch 50 mcg/24 h Novartis Pharma AG 31/03/07<br />

4319 Estraderm MX 100 Estradiolum Transdermal patch 100 mcg/24 h Novartis Pharma AG 31/03/07<br />

4320 Estraderm TTS 25 Estradiolum Transdermal patch 25 mcg/24h Novartis Pharma AG 31/05/04<br />

4321 Estraderm TTS 50 Estradiolum Transdermal patch 50 mcg/24h Novartis Pharma AG 31/05/04<br />

4322 Estraderm TTS 100 Estradiolum Transdermal patch 100 mcg/24h Novartis Pharma AG 31/05/04<br />

4323 Estradiol Estradiolum Cream 0,01 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

4325 Estradiol Estradiolum Gel 0,06 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

4324 Estradiol Estradiolum Tablets 2 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

4326 Estradiol — Depot Estradiolum Solution for injection 10 mg/1 ml Jenapharm GmbH & Co. 31/07/04<br />

4327 Estradot 100 Estradiolum Transdermal patch 100 mcg/24 h Novartis Pharma AG 21/03/07<br />

4328 Estradot 37,5 Estradiolum Transdermal patch 37.5 mcg/24 h Novartis Pharma AG 21/03/07<br />

4329 Estradot 50 Estradiolum Transdermal patch 50 mcg/24 h Novartis Pharma AG 21/03/07<br />

4330 Estradot 75 Estradiolum Transdermal patch 75 mcg/24 h Novartis Pharma AG 21/03/07<br />

4331 Estradot® 25 Estradiolum Transdermal patch 0,39 mg;<br />

25 µg/dobe˛<br />

Novartis Pharma AG 31/12/08<br />

4332 Estreva Estradiolum Gel 0.1 % Theramex Laboratory 12/09/07<br />

4333 Estrimax Estradiolum Film-coated tablets 2 mg Chemical Works of Gedeon<br />

Richter Ltd.<br />

31/12/08<br />

4334 Estring Estradiolum Vaginal disc PHARMACIA AB 30/09/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 947<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4335 Estrium 100 Estradiolum Transdermal patch 8 mg<br />

(100 mcg/24h)<br />

4336 Estrium 25 Estradiolum Transdermal patch 2 mg (25 mcg/<br />

24h)<br />

4337 Estrium 50 Estradiolum Transdermal patch 4 mg (50 mcg/<br />

24h)<br />

Hexal AG 16/08/04<br />

Hexal AG 24/05/06<br />

Hexal AG 24/05/06<br />

4338 Estrofem Estradiolum Film-coated tablets 2 mg Novo Nordisk A/S 31/01/05<br />

4339 Estrofem forte Estradiolum Film-coated tablets 4 mg Novo Nordisk A/S 31/01/05<br />

4340 Estrofem mite Estradiolum Film-coated tablets 1 mg Novo Nordisk A/S 31/08/05<br />

4341 Estromikron Estradiolum Tablets 0.5 mg Adamed Sp. z o.o. 31/12/08<br />

4342 Estromikron Estradiolum Tablets 1 mg Adamed Sp. z o.o. 31/12/08<br />

4343 Estromikron Estradiolum Tablets 2 mg Adamed Sp. z o.o. 31/12/08<br />

4344 Estroplast 40 Estradiolum Pach 40 mcg/24 h Adamed Sp. z o.o. 31/12/07<br />

4345 Estroplast 80 Estradiolum Pach 80 mcg/24 h Adamed Sp. z o.o. 31/12/07<br />

4346 Estrumate Kloprostenol Solution for veterinary<br />

use<br />

Schering-PloughCentral East<br />

Ag<br />

4347 Etakrydyny mleczan Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

4348 Etakrydyny mleczan Margo Corporation,<br />

Warszawa<br />

13/04/06<br />

31/03/06<br />

31/03/06<br />

4349 Etakrydyny mleczan Pharma Cosmetic, Kraków 31/03/06<br />

4350 Etakrydyny mleczan Pharma Zentrale 31/03/06<br />

4351 Etakrydyny mleczan PPF GEMI, Karczew 31/03/06<br />

4352 Etakrydyny mleczan Prolab, Paterek k/Nakła 31/03/06<br />

4353 Etakrydyny mleczan Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

4354 Etakrydyny mleczan<br />

(Ethacridini lactas)<br />

PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/03/06<br />

4/03/07<br />

4355 Etanol 760 g/l Ethanolum 760 g/l Polmos Wrocław 24/02/05<br />

4356 Etanol 760g/l Ethanolum 760 g/l Farm-Impex s.j., Gliwice 29/09/07<br />

4357 Etanol 760g/l Ethanolum 760 g/l Gruntpol, Kalisz 29/09/07<br />

4358 Eter etylowy Aliachem, Czechy 9/04/05<br />

4359 Eter etylowy stabil. fenidonem Lachema, Czechy 31/12/05<br />

4360 ETER ETYLOWY stabilizowany<br />

fenidonem<br />

Slovgal s.r.o. 31/08/07<br />

4361 Ethambutol Ethambutolum Capsules 250 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4362 Ethisteron Ethisteronum Sublingual tablets 25 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

4363 Ethylex Naltrexonum Film-coated tablets 50 mg Aop Orphan Pharmaceuticals<br />

AG<br />

30/11/05<br />

30/11/05<br />

31/12/08


EN<br />

948 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4364 Ethyol Amifostinum Powder for solution<br />

for infusion<br />

4365 Etimonis Isosorbidi mononitras Prolonged release<br />

capsules<br />

4366 Etimonis Isosorbidi mononitras Prolonged release<br />

capsules<br />

4367 Etimonis Isosorbidi mononitras Prolonged release<br />

capsules<br />

4368 Etofina Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Ethoxybenzamidum<br />

500 mg USB Farma, Holandia 21/07/07<br />

20 mg Yamanouchi Europe B.V. 30/09/04<br />

40 mg Yamanouchi Europe B.V. 30/09/04<br />

60 mg Yamanouchi Europe B.V. 30/09/04<br />

Tablets Przedsie˛biorstwo<br />

Farmaceutyczne Okoniewscy<br />

S.C.‘VETOS-FARMA’<br />

4369 Etogesic tbl .150 g Etodolak Tablets for veterinary<br />

use<br />

4370 Etogesic tbl .300 g Etodolak Tablets for veterinary<br />

use<br />

4371 Etomar Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Ethenzamidum<br />

4372 Etomedac Etoposidum Concantrate for<br />

solution for<br />

intravenous infusion<br />

4373 Etomidate-Lipuro Etomidatum Emulsion for<br />

intravenous injection<br />

4374 ETOPIRYNA Plus Tabletki Od<br />

Bólu Głowy<br />

4375 Etopiryna- tabletki od bólu<br />

głowy<br />

Acidum acetulsalicylicum<br />

+ Coffeinum<br />

Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Ethoxybenzamidum<br />

10/05/06<br />

Fort Dodge 31/12/08<br />

Fort Dodge 31/12/08<br />

Tablets Marcmed s.c. 31/03/06<br />

Tablets 450 mg +<br />

50 mg<br />

4376 Etopophos Etoposidum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

20 mg/ml medac Gesellschaft medac<br />

Gesellschaft für klinische<br />

Spezialpräparate mbH<br />

31/12/08<br />

2 mg/ml B. Braun Melsungen AG 31/12/04<br />

Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

100 mg Bristol Myers Squibb<br />

Company<br />

31/12/08<br />

31/01/06<br />

25/04/07<br />

4377 Etoposide Etoposidum Solution for injection 20 mg/ml Pharmacia & Upjohn Pty Ltd. 31/01/05<br />

4378 Etoposide Concentrate for<br />

solution for infusion<br />

4379 Etoposide- Pierre Fabre Etoposidum Concentrate for<br />

solution for<br />

intravenous infusion<br />

4380 Etoposid-Ebewe, Etoposid-<br />

Knoll<br />

4381 Etoposid-Ebewe, Etoposid-<br />

Knoll<br />

4382 Etoposid-Ebewe, Etoposid-<br />

Knoll<br />

4383 Etoposid-Ebewe, Etoposid-<br />

Knoll<br />

Etoposidum Concentrate for<br />

solution for<br />

intravenous infusion<br />

and for oral use<br />

Etoposidum Concentrate for<br />

solution for<br />

intravenous infusion<br />

and for oral use<br />

Etoposidum Concentrate for<br />

solution for<br />

intravenous infusion<br />

and for oral use<br />

Etoposidum Concentrate for<br />

solution for<br />

intravenous infusion<br />

and for oral use<br />

100 mg / 5 ml VIPHARM S.A. Warszawa 31/01/05<br />

100 mg/5ml Pierre Fabre Medicament<br />

Idron<br />

12/10/05<br />

100 mg/5 ml EBEWE Arzneimittel GmbH 31/12/08<br />

200 mg/10 ml EBEWE Arzneimittel GmbH 31/12/08<br />

400 mg/20 ml EBEWE Arzneimittel GmbH 31/12/08<br />

50 mg/2,5 ml EBEWE Arzneimittel GmbH 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 949<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4384 Etoposide-Teva Etoposidum Concentrate for<br />

solution for infusion<br />

4385 Etoprexum Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Ethoxybenzamidum<br />

4386 Etoprexum Plus Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Ethoxybenzamidum<br />

Tablets 300 mg +<br />

50 mg +<br />

100 mg<br />

Tablets 500 mg +<br />

50 mg +<br />

100 mg<br />

20 mg/ml ABIC TEVA Group 31/01/05<br />

Labpharm Sp. z o.o. 31/12/08<br />

Labpharm Sp. z o.o. 31/12/08<br />

4387 Etoran Paracetamolum Tablets 500 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

4388 Etoran Extra Coffeinum +<br />

Paracetamolum<br />

4389 Etoran Max Codeinum +<br />

Paracetamolum<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/03/07<br />

31/03/07<br />

30/04/06<br />

4390 Etylefryna Ethylefrinum Tablets 5 mg Instytut Farmaceutyczny 31/12/08<br />

4391 Etylomorfiny chlorowodorek Polfa Kutno 16/01/06<br />

4392 Etylu aminobenzoesan A.C.E.F., Włochy 31/12/08<br />

4393 Etylu aminobenzoesan Farm-Impex s.j., Gliwice 31/12/08<br />

4394 Etylu aminobenzoesan Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

4395 Etylu aminobenzoesan Margo Corporation,<br />

Warszawa<br />

31/12/08<br />

31/12/08<br />

4396 Etylu aminobenzoesan Pampa, Piaseczno 31/12/08<br />

4397 Etylu aminobenzoesan Pharma Cosmetic, Kraków 31/12/08<br />

4398 Etylu aminobenzoesan Pharma Zentrale 31/12/08<br />

4399 Etylu hydroksybenzoesan Pharma Zentrale 9/01/05<br />

4400 Eucalyptosan Eucalypti oleum Capsules, soft 200 mg R.P. Scherer GmbH & Co. KG 31/12/08<br />

4401 EUCALYPTUS comp. ampułki WALA-Heilmittel GmbH 19/03/05<br />

4402 EUCALYPTUS comp. granulki WALA-Heilmittel GmbH 19/03/05<br />

4403 Eucardin Aminophyllinum +<br />

Papaverinum +<br />

Phenobarbitalum +<br />

Nitroglycerinum<br />

4404 Eucerinum (Euceryna<br />

bezwodna)<br />

Tablets Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

Ointment base Coel s.c.- Laboratorium<br />

Farmaceutyczne Wytwórnia<br />

Euceryny<br />

4405 Eucertan Ointment base Coel s.c.- Laboratorium<br />

Farmaceutyczne Wytwórnia<br />

Euceryny<br />

4406 Euceryna apteczna Ointment base Ziaja Ltd. — Zakład<br />

Produkcji Leków<br />

4407 Euceryna Bezwodna Eucerinum anhydricum Ointment base Laboratorium Galenowe<br />

‘LEFARM’ Sp. z o.o.<br />

4408 Euceryna bezwodna Podłoz˙e mas´ciowe Ointment base Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/12/07<br />

31/01/06<br />

31/01/06<br />

31/05/06<br />

31/12/08<br />

31/12/08


EN<br />

950 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4409 Euceryna bezwodna Ointment base Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

4410 Euceryna bezwodna II Ointment base Ewa-Anna Wytwórnia<br />

Euceryny Farmaceutycznej<br />

4411 Euceryna bezwodna S Ointment base Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

4412 Euclamin Glibenclamidum Tablets 5 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/12/08<br />

30/04/06<br />

15/03/06<br />

31/01/06<br />

4413 Euforal Hyperici extractum sicc. Gelatin capsules, hard 75 mg Krotex Poland Sp. z o.o. 31/12/08<br />

4414 Eugenol Chema-Elektromet, Rzeszów 31/12/07<br />

4415 Eukaliptiss Ointment Naturwaren OHG Dr Peter<br />

Theiss<br />

4416 Eupatorium Pentarkan Drops DHU-Arzneimittel GmbH &<br />

Co.KG<br />

31/05/04<br />

19/03/06<br />

4417 Euphorbium comp. SN Amp. Heel GmbH 30/06/07<br />

4418 Euphorbium Compositum S Nasal drops Heel GmbH 30/06/07<br />

4419 Euphorbium compositum SN Oral drops Heel GmbH 30/06/07<br />

4420 Euphorium Compositum SN Nasal drops Heel GmbH 30/06/07<br />

4421 Euphrasia Eye drops 0,5ml WALA-Heilmittel GmbH 24/05/07<br />

4422 Euphrasia complexe nr 115 Drops Lehning Laboratoires 4/01/07<br />

4423 Euphrasia-Dagomed 22 stany<br />

zapalne oczu<br />

4424 Euphyllin CR Retard Theophyllinum Film-coated, prologed<br />

release tablets<br />

4425 Euphyllin long Theophyllinum Modified release<br />

capsules<br />

4426 Euphyllin long Theophyllinum Modified release<br />

capsules, hard<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

250 mg Byk Gulden Pharmaceutica 23/04/06<br />

300 mg Altana Pharma AG 30/11/04<br />

200 mg Altana Pharma AG 30/11/04<br />

4428 Eurespal Fenspiridum Film-coated tablets 80 mg Les Laboratoires Servier 31/12/08<br />

4427 Eurespal Fenspiridum Syrup 2 mg/ml Les Laboratoires Servier 31/12/08<br />

4429 Eurical L Szczepionka przeciw<br />

leptospirozie , psów<br />

4430 Eurican DHPPI 2 Szczepionka przeciw<br />

nosówce, zakaz˙eniom<br />

adenowirusowym,<br />

parwowirusowym oraz<br />

zakaz˙eniom wirusem<br />

parainfluenzy typ 2<br />

4431 Euro — Collins Liquid for organ<br />

perfusion<br />

4432 Euterin Eleuterococcus senticosus<br />

extractum siccum<br />

4433 Euthyrox 25 Levothyroxinum<br />

natricum<br />

4434 Euthyrox 50 Levothyroxinum<br />

natricum<br />

Liquid for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Merial 24/05/04<br />

Merial SAS 4/02/04<br />

Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

Film-coated tablets 98 mg Wrocławskie Zakłady<br />

Zielarskie HERBAPOL S.A.<br />

31/07/04<br />

31/12/08<br />

Tablets 25 mcg Merck KGaA 17/07/06<br />

Tablets 50 mcg Merck KGaA 30/06/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 951<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4435 Euthyrox 100 Levothyroxinum<br />

natricum<br />

4436 Euthyrox 125 Levothyroxinum<br />

natricum<br />

4437 Euthyrox 150 Levothyroxinum<br />

natricum<br />

4438 Euthyrox 175 Levothyroxinum<br />

natricum<br />

4439 Euthyrox 200 Levothyroxinum<br />

natricum<br />

4440 Euthyrox 75 Levothyroxinum<br />

natricum<br />

4441 Euthyrox N 100 Levothyroxinum<br />

natricum<br />

4442 Euthyrox N 125 Levothyroxinum<br />

natricum<br />

4443 Euthyrox N 150 Levothyroxinum<br />

natricum<br />

4444 Euthyrox N 175 Levothyroxinum<br />

natricum<br />

4445 Euthyrox N 200 Levothyroxinum<br />

natricum<br />

4446 Euthyrox N 25 Levothyroxinum<br />

natricum<br />

4447 Euthyrox N 50 Levothyroxinum<br />

natricum<br />

4448 Euthyrox N 75 Levothyroxinum<br />

natricum<br />

4449 Euvax B (dla dorosłych) Hepatitis B, purified<br />

antigen<br />

4450 Euvax B (dla dorosłych) Hepatitis B, purified<br />

antigen<br />

4451 Euvax B (dla dzieci) Hepatitis B, purified<br />

antigen<br />

4452 Euvax B (dla dzieci) Hepatitis B, purified<br />

antigen<br />

4453 Evana Agni casti fructus<br />

extractum siccum<br />

4454 Evening primrose oil Oenotherae paradoxa<br />

oleum<br />

Tablets 100 mcg Merck KGaA 30/06/04<br />

Tablets 125 mcg Merck KGaA 17/07/06<br />

Tablets 150 mcg Merck KGaA 30/06/04<br />

Tablets 175 mcg Merck KGaA 17/07/06<br />

Tablets 200 mcg Merck KGaA 17/07/06<br />

Tablets 75 mcg Merck KGaA 17/07/06<br />

Tablets 100 µg Merck KGaA 31/12/08<br />

Tablets 125 µg Merck KGaA 31/12/08<br />

Tablets 150 µg Merck KGaA 31/12/08<br />

Tablets 175 µg Merck KGaA 31/12/08<br />

Tablets 200 µg Merck KGaA 31/12/08<br />

Tablets 25 µg Merck KGaA 31/12/08<br />

Tablets 50 µg Merck KGaA 31/12/08<br />

Tablets 75 µg Merck KGaA 31/12/08<br />

Suspension for<br />

intramuscular<br />

injection<br />

Suspension for<br />

intramuscular<br />

injection<br />

Suspension for<br />

intramuscular<br />

injection<br />

Suspension for<br />

intramuscular<br />

injection<br />

Film-coated tablets 3,2mg —<br />

4,8mg<br />

20 mcg/ 1 ml LG Chemical Ltd 12/10/05<br />

200 mcg/10 ml Lg Chemical Ltd Iksan<br />

Factory of Chemical Ltd<br />

12/10/05<br />

10 mcg/0,5 ml LG Chemical Ltd 12/10/05<br />

100 mcg/5 ml Lg Chemical Ltd Iksan<br />

Factory of Chemical Ltd<br />

Boehringer Ingelheim<br />

International GmbH<br />

12/10/05<br />

30/06/05<br />

Capsules, soft 500 mg PRO NATURA s.j. 31/12/08<br />

4455 Evening Primrose Oil Capsules Power Health Products Ltd. 29/02/04<br />

4456 Evetsel Tocopherolum + Natrii<br />

selenas<br />

Liquid for veterinary<br />

use<br />

Pliva Kraków 17/08/04<br />

4457 Evista Raloxifenum Film-coated tablets 60 mg Eli Lilly and Company Ltd 30/11/04<br />

4458 Ewit Tocopherolum Capsules 400 mg Sun-Farm Sp.z o.o. Kołbiel 14/12/05


EN<br />

952 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4462 Exacyl Acidum tranexamicum Film-coated tablets 500 mg Sanofi Winthrop-Gentilly 30/04/04<br />

4461 Exacyl Acidum tranexamicum Oral solution 1 g/10 ml Sanofi Winthrop-Gentilly 30/04/04<br />

4459 Exacyl Acidum tranexamicum Solution for<br />

intravenous injection<br />

4460 Exacyl Acidum tranexamicum Solution for<br />

intravenous injection<br />

4463 Excenel Ceftiofur sodowy Powder for veterinary<br />

use<br />

4464 Excenel RTU Ceftiofuru<br />

chlorowodorek<br />

Suspension for veterinary<br />

use<br />

100 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/06/06<br />

100 mg/ml Sanofi Winthrop-Gentilly 31/12/04<br />

Pharmacia N.V./S.A. 31/12/08<br />

Pharmacia N.V./S.A. 23/10/06<br />

4465 Exelon Rivastigminum Capsules 1.5 mg Novartis Pharma AG 31/12/08<br />

4466 Exelon Rivastigminum Capsules 3 mg Novartis Pharma AG 31/12/08<br />

4467 Exelon Rivastigminum Capsules 4.5 mg Novartis Pharma AG 31/12/08<br />

4468 Exelon Rivastigminum Capsules 6 mg Novartis Pharma AG 31/12/08<br />

4469 Exelon Rivastigminum Solution for drink 2 mg/ml Novartis Pharma AG 31/12/04<br />

4470 Exmykehl D3 Sanum-Kehlbeck 31/12/05<br />

4471 Exoderil Naftifinum Cream 10 mg/g Biochemie GmbH — Kundl 31/07/04<br />

4472 Exorex Pix litanthracis Cutaneous emulsion 10 mg Meyer Zall Laboratoires (Pty)<br />

Ltd<br />

4473 Exosurf Colfoscerili palmitas Powder and solvent for<br />

endotracheopulmonary<br />

instillation, suspension<br />

108 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

4474 Expeflos Herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

4475 Exspot Permetryna Liquid for veterinary<br />

use<br />

Schering-Plough Central East<br />

Ag<br />

22/02/06<br />

30/06/04<br />

31/12/07<br />

4/01/06<br />

4476 Exter Omeprazolum Capsules 20 mg Rubio Laboratorios S.A. 16/01/06<br />

4477 Extract aloe Aloe extractum fluidum Subcutaneous<br />

injection<br />

Moscow Endocriny Plant 31/12/08<br />

4478 Extractum Thymi Fluidum Thymi extractum fluidum Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

4479 Extrall-Solutio Liquid for external use 137 mg/ml Cefarm Lublin S.A.<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

4480 Extrall-Unguentum Ointment 150 mg/g Cefarm Lublin S.A.<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

4481 Fabrazyme Agalsidasum beta Powder for<br />

concentrate for<br />

solution for infusion<br />

30/10/05<br />

30/10/05<br />

35 mg Genzyme Europe B.V. 30/09/07<br />

4482 Fagastin 20 Famotidinum Film-coated tablets 20 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4483 Fagastin 40 Famotidinum Film-coated tablets 40 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/10/05<br />

30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 953<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4484 Faklocyn Cefaclorum Capsules 250 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4485 Faklocyn Cefaclorum Capsules 500 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4486 Falibaryt — Colon Powder for<br />

suspension<br />

4487 Falibaryt HD Powder for<br />

suspension<br />

31/12/08<br />

31/12/08<br />

95.854 g/100 g Goldham Arzneimittel GmbH 31/12/08<br />

96.805 g/<br />

100 ml<br />

Goldham Arzneimittel GmbH 31/12/08<br />

4488 Falvit Coated tablets Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

4489 Falvit Film-coated tablets Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

4490 Falvit M Preparat złoz˙ony Film-coated tablets Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

4491 Famidyna Famotidinum Film-coated tablets 10 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/12/08<br />

30/11/05<br />

31/12/08<br />

29/11/06<br />

4492 Famodin Famotidinum Tablets 20 mg Polfarmex S.A. 31/12/08<br />

4493 Famodin Famotidinum Tablets 40 mg Polfarmex S.A. 31/12/08<br />

4494 Famogast Famotidinum Film-coated tablets 20 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

4495 Famogast Famotidinum Film-coated tablets 40 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

30/10/05<br />

4496 Famosan Famotidinum Film-coated tablets 20 mg PRO. MED. C.S., Praha a.s. 31/12/08<br />

4497 Famosan Famotidinum Film-coated tablets 40 mg PRO. MED. C.S., Praha a.s. 31/12/08<br />

4498 Famotidine Famotidinum Film-coated tablets 40 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/01/05<br />

4499 Famulan Drops Richard Bittner 9/09/07<br />

4500 Famvir Famciclovirum Film-coated tablets 125 mg Novartis Pharma AG 31/12/08<br />

4501 Famvir Famciclovirum Film-coated tablets 250 mg Novartis Pharma AG 24/06/06<br />

4502 FANHDI Coagulation factor VIII Intravenous injection<br />

(lyophilisate)<br />

4503 FANHDI Coagulation factor VIII Intravenous injection<br />

(lyophilisate)<br />

4504 FANHDI Coagulation factor VIII Intravenous injection<br />

(lyophilisate)<br />

1000 j.m. Instituto Grifols S.A. 31/12/08<br />

250 j.m. Instituto Grifols S.A. 31/12/08<br />

500 j.m. Instituto Grifols S.A. 31/12/08<br />

4505 Fantomalt Powder Nutricia Cuijk B.V 30/06/07<br />

4506 Farfaron Farfarae extractum<br />

spissum, Sirupus<br />

althaeae<br />

4507 Farfplant Farfarae folium succus +<br />

Plantaginis herba<br />

extractum fluidum<br />

Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Syrup (296mg +<br />

296mg)/5ml<br />

Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

31/12/08<br />

17/01/07<br />

4508 Faringosept Ambazonum Tablets 10 mg S.C. Terapia S.A. 31/12/08<br />

4509 Farlutal 250 Medroxyprogesteronum Tablets 250 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

30/06/04


EN<br />

954 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4510 Farlutal 500 Medroxyprogesteronum Tablets 500 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

4511 Farmatan Tanina Powder for veterinary<br />

use<br />

4512 Farmorubicin PFS Epirubicinum Solution for<br />

intravenous injection<br />

4513 Farmorubicin PFS Epirubicinum Solution for<br />

intravenous injection<br />

4515 Farmorubicin RD Epirubicinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

4514 Farmorubicin RD Epirubicinum Lyophilisate for<br />

solution for injection<br />

4516 Farmox 15 % Amoxicillunum Powder for veterinary<br />

use<br />

4517 FarrowSure PlusB inaktywowana<br />

szczepionka dla s´wiń<br />

do uodparniania<br />

zdrowych s´wiń<br />

hodowlanych<br />

przeciwko<br />

zaburzeniom rozrodu<br />

4518 Fastjekt Epinephrinum Solution for<br />

intramuscular<br />

injection<br />

Suspension for veterinary<br />

use<br />

30/06/04<br />

Tanin Sevnica 22/11/06<br />

10 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

50 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

10 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

50 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

31/12/08<br />

31/12/08<br />

30/06/04<br />

30/06/04<br />

Vetimex Animal Health B.V. 15/11/04<br />

Pfizer 31/12/08<br />

1 mg/ml Allergopharma Joachim<br />

Ganzer KG<br />

4519 Fastum Ketoprofenum Gel 2.5 % (25mg/g) A.Menarini Pharmaceutical<br />

Industries Group Ltd.<br />

4520 Fasturtec Rasburicasum Powder and solvent<br />

for concentrate for<br />

solution for<br />

intravenous infusion<br />

4521 Fatroximin D.C. Rifaksimina Intramammary<br />

suspension<br />

1.5 mg/ml<br />

(1,5mg)<br />

for veterinary<br />

use<br />

4522 Fatroximin Intrauterine Foam Rifaksimina Vaginal spray for veterinary<br />

use<br />

4523 Fatroximin Topic Spray Rifaksimina Spray for veterinary<br />

use<br />

4524 Fatrybanil Diminazenu aceturan,<br />

Fenazon<br />

Solution for veterinary<br />

use<br />

30/06/07<br />

31/12/07<br />

Sanofi-Synthelabo France 25/04/07<br />

FATRO 20/06/05<br />

FATRO 20/06/05<br />

Fatro 17/07/05<br />

Fatro 14/08/05<br />

4525 Faxin Venlafaxinum Tablets 75 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4526 Faxin Venlafaxinum Tablets 37,5 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4527 Febrisan Paracetamolum +<br />

Phenylephrinum +<br />

Acidum ascorbicum<br />

31/12/08<br />

31/12/08<br />

Effervescent powder Byk Roland Polska 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 955<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4528 Febrivac 3-Plus Inaktywowana<br />

szczepionka dla norek<br />

przeciw zakaz´nemu<br />

zapaleniu jelit,<br />

botulizmowi i<br />

zakaz˙eniom<br />

wywoływanym przez<br />

Pseudomonas<br />

aeruginosa<br />

4529 Febrivac DIST Atenuowana<br />

szczepionka dla norek<br />

i fretek przeciwko<br />

nosówce<br />

Suspension for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Impfstoffwerk Dessau-Tornau<br />

GmbH<br />

Impfstoffwerk Dessau-Tornau<br />

GmbH<br />

4531 Febrofen Ketoprofenum Gel 25 mg/g Medana Pharma Terpol<br />

Group S.A.<br />

4530 Febrofen Ketoprofenum Prolonged release<br />

capsules<br />

4532 Feiba Tim 4 Immuno Coagulation factor VIII<br />

(zespół czynnikow<br />

krzepnie˛cia przeciw<br />

inhibitorowi cz. VIII —<br />

poddany dziłaniu pary)<br />

4533 Feiba Tim 4 Immuno Coagulation factor VIII<br />

(zespół czynnikow<br />

krzepnie˛cia przeciw<br />

inhibitorowi cz. VIII —<br />

poddany dziłaniu pary)<br />

Powder and solvent<br />

for solution for<br />

intravenous injection<br />

Powder and solvent<br />

for solution for<br />

intravenous injection<br />

200 mg Medana Pharma Terpol<br />

Group S.A.<br />

1000 j.m.=<br />

1000 jednostek<br />

FEIBA<br />

500 j.m. + 500<br />

jednostek<br />

FEIBA<br />

16/04/07<br />

6/05/07<br />

31/05/05<br />

30/11/05<br />

Baxter AG 19/05/06<br />

Baxter AG 19/05/06<br />

4534 Feksat Fexofenadinum Film-coated tablets 120 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4535 Feksat Fexofenadinum Film-coated tablets 60 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4536 Feksat Fexofenadinum Film-coated tablets 180 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4537 Feksat Plus Fexofenadinum Modified release<br />

tablets<br />

4538 Fel Tauri Complexe Lehning<br />

nr 113<br />

60 mg +<br />

120 mg<br />

Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Tablets Lehning Laboratoires 2/06/07<br />

4540 Feldene Piroxicamum Capsules 10 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

4541 Feldene Piroxicamum Capsules 20 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

4543 Feldene Piroxicamum Gel 5 mg/g Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

4542 Feldene Piroxicamum Solution for injection 20 mg/1 ml Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

4539 Feldene Piroxicamum Suppository 20 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

4544 Felis 425 Hyperici herbae<br />

extractum siccum<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

Capsuels, hard 425 mg Biocur Arzneimittel GmbH 31/12/04


EN<br />

956 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4545 Felisvac Mc Inaktywowana<br />

szczepionka dla kotów<br />

przeciw grzybicy<br />

skórnej<br />

4546 Felixen Piperis methystici<br />

rhizomae extractum<br />

siccum<br />

4547 Felixen forte Piperis methystici<br />

extractum siccum<br />

4548 Felocell CVR Szczepionka dla kotów<br />

przeciwko<br />

panleukopeni,<br />

zakaz´nemu zapaleniu<br />

jamy nosowej i<br />

tchawicy oraz<br />

kaliciwirozie<br />

4550 Felodif Felodipinum Film-coated,<br />

prolonged release<br />

tablets<br />

4549 Felodif Felodipinum Prolonged release<br />

tablets<br />

Suspension for veterinary<br />

use<br />

Film-coated tablets 40 mg<br />

kawa-pironów<br />

Film-coated tablets 120 mg<br />

kawapironów<br />

Lyophilisate for veterinary<br />

use<br />

Biowet Puławy Sp. z o.o. 24/07/07<br />

P.P.H.U. Biofarm Sp. z o.o. 25/01/06<br />

P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

Pfizer 31/12/08<br />

10 mg Instytut Farmaceutyczny 31/12/08<br />

5 mg Instytut Farmaceutyczny 31/12/08<br />

4554 Feloran Diclofenacum Film-coated tablets 25 mg Pharmachim-Holding AD 30/06/04<br />

4555 Feloran Diclofenacum Gel 10 mg/g Pharmachim-Holding AD 31/07/04<br />

4553 Feloran Diclofenacum Solution for<br />

intramuscular<br />

injection<br />

25 mg/ml Pharmachim-Holding AD 30/06/04<br />

4551 Feloran Diclofenacum Suppository 25 mg Pharmachim-Holding AD 30/06/04<br />

4552 Feloran Diclofenacum Suppository 50 mg Pharmachim-Holding AD 30/06/04<br />

4556 Feloten Felodipinum Film-coated,<br />

prolonged release<br />

tablets<br />

4557 Feloten Felodipinum Film-coated,<br />

prolonged release<br />

tablets<br />

4558 Feloten Felodipinum Film-coated,<br />

prolonged release<br />

tablets<br />

4559 Fel-O-Vax 3 Szczepionka przeciw<br />

schorzeniom górnych<br />

dróg oddechowych<br />

wywołanych przez<br />

herpeswirusy,<br />

kaliciwirusy oraz<br />

wirusy panleukopenii<br />

kotów<br />

4560 Fel-O-Vax 4 Inaktywowana<br />

szczepionka dla kotów<br />

przeciw schorzeniom<br />

górnych dróg<br />

oddechowych<br />

wywołanym przez<br />

herpeswirusy,<br />

kaliciwirusy oraz<br />

Chalmydia psitaci,<br />

panleukopenii<br />

Suspension for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

2,5 mg IVAX PHARMA POLAND Sp.<br />

z o.o.<br />

5 mg IVAX PHARMA POLAND Sp.<br />

z o.o.<br />

10 mg IVAX PHARMA POLAND Sp.<br />

z o.o.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Fort Dodge 31/12/08<br />

Fort Dodge 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 957<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4561 Fel-O-Vax 5 Inaktywowana<br />

szczepionka dla kotów<br />

przeciw schorzeniom<br />

górnych dróg<br />

oddechowych<br />

wywołanym przez<br />

herpeswirusy,<br />

kaliciwirusy oraz<br />

Chalmydia psitaci,<br />

białaczce,<br />

panleukopenii<br />

Suspension for veterinary<br />

use<br />

Fort Dodge Animal Health 4/02/07<br />

4562 Fem 7 Estradiolum Transdermal patch 50 mcg/dobe˛ Merck KGaA 31/12/08<br />

4563 Fem 7 Combi Estradiolum +<br />

Levonorgestrelum<br />

4564 Fem Hrt Norethisteronum +<br />

Ethynylestradiolum<br />

Transdermal patch 50 µg + 10 µg Merck KGaA 31/12/08<br />

Tablets 1 mg/5 mcg Pfizer Polska Sp. z o.o. 31/12/08<br />

4565 FEMACTIVE 1 mg Oestradiolum Film-coated tablets 1 mg Bristol — Myers Squibb 31/12/08<br />

4566 FEMACTIVE 2 mg Oestradiolum Film-coated tablets 2 mg Bristol — Myers Squibb 31/12/08<br />

4567 Femactive C Oestradiolum +<br />

Norethisteronum<br />

4568 FEMACTIVE PLUS 1 mg Oestradiolum +<br />

Norethisteronum<br />

4569 FEMACTIVE PLUS 2 mg Oestradiolum +<br />

Norethisteronum<br />

Film-coated tablets 2 mg + 1 mg Bristol — Myers Squibb 31/12/08<br />

Film-coated tablets 1 mg + 1 mg/<br />

1mg<br />

Film-coated tablets 2 mg + 2 mg/<br />

1mg<br />

Bristol — Myers Squibb 31/12/08<br />

Bristol — Myers Squibb 31/12/08<br />

4570 Femara Letrozolum Film-coated tablets 2.5 mg Novartis Pharma AG 31/12/08<br />

4571 Femibion Film-coated tablets Merck KGaA 14/12/05<br />

4572 Femicur® n capsules Agni casti fructus<br />

extractum siccum<br />

4573 Femigen Norgestimatum +<br />

Ethinylestradiolum<br />

Capsules, hard 4 mg Schaper & Brümmer GmbH<br />

& Co.KG<br />

Tablet 0,25 mg +<br />

0,035 mg<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/08<br />

4574 Feminatal Film-coated tablets Merck KGaA 30/09/05<br />

4575 Feminon N Cesra-ArzneimittelFabrik<br />

GmbH & Co, Niemcy<br />

4576 Feminon pms(poprzednia<br />

nazwa masto-feminon)<br />

4577 Feminon-klim(poprzednia<br />

nazwa klima-feminon)<br />

Vitex agnus castus<br />

extractum siccum<br />

Cimicifugae racemosae<br />

rhizomae extractum<br />

siccum<br />

Capsules, hard 4 mg Cesra — Arzneimittel GmbH<br />

& Co. KG<br />

Capsules, hard 6,5 mg Cesra — Arzneimittel GmbH<br />

& Co. KG<br />

14/04/07<br />

31/12/08<br />

31/12/08<br />

4578 Feminosan Herbal tea Herbapol Lublin S.A. 31/12/08<br />

4579 Feminosept fix Herbal tea Herbapol Lublin S.A. 31/12/07<br />

4580 Femoden Ethinylestradiolum +<br />

Gestodenum<br />

4581 Femoston 1/10 Estradiolum +<br />

Hydrogesteronum<br />

4582 Femoston 2/10 Dydrogesteronum +<br />

Estradiolum<br />

4583 Femoston 2/20 Dydrogesteronum +<br />

Estradiolum<br />

Film-coated tablets Schering AG 30/04/04<br />

Tablets 1 mg Solvay Pharmaceuticals B.V. 31/12/08<br />

Film-coated tablets 10mg + 2mg Solvay Pharmaceuticals B.V. 31/05/04<br />

Film-coated tablets 20mg + 2mg Solvay Pharmaceuticals B.V. 31/05/04


EN<br />

958 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4584 Femoston Conti Estradiolum +<br />

Dydrogesteronum<br />

Tablets Solvay Pharma B.V. 29/09/07<br />

4585 Fenacetyna A.C.E.F., Włochy 31/12/08<br />

4586 Fenactil Chlorpromazinum Coated tablets 100 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4587 Fenactil Chlorpromazinum Coated tablets 25 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

4588 Fenactil Chlorpromazinum Coated tablets 25 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4589 Fenactil Chlorpromazinum Oral drops, solution 40 mg/g Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

4590 Fenactil Chlorpromazinum Solution for injection 5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

4591 Fenactil Chlorpromazinum Solution for<br />

intravenous injection<br />

4592 Fenalgin Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Paracetamolum<br />

4593 Fenbegran 20 % Fenbendazol Granules for veterinary<br />

use<br />

4594 Fenbenat proszek 4 % Fenbendazol 4 % Powder for veterinary<br />

use<br />

4595 Fenbenat tabletki 0,125 Fenbendazol Tablets for veterinary<br />

use<br />

4596 Fenbenat tabletki 0,250 Fenbendazol Tablets for veterinary<br />

use<br />

4597 Fenbendazol z˙el Fenbendazol Gel for veterinary<br />

use<br />

4598 Fenbesan Fenbendazol Powder for veterinary<br />

use<br />

25 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05<br />

30/11/05<br />

30/06/06<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

Tablets Lek Pharmaceuticals d.d. 30/04/05<br />

Biowet Puławy 31/12/08<br />

Naturan 10/08/04<br />

Vet-Agro 31/12/08<br />

Vet-Agro 31/12/08<br />

aniMedica 18/09/07<br />

BASF 31/12/08<br />

4599 Fenbufen Fenbufenum Tablets 300 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

4600 Fenicort Prednisolonum Lyophilisate for<br />

solution for injection<br />

25 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

4601 Fenistil Dimetindenum Cutaneous emulsion 1 mg/g Novartis Consumer Health<br />

S.A.<br />

4605 Fenistil Dimetindenum Gel 1 mg/g Novartis Consumer Health<br />

S.A.<br />

4603 Fenistil Dimetindenum Oral drops, solution 1 mg/ml Novartis Consumer Health<br />

S.A.<br />

4602 Fenistil Dimetindenum Prolonged release<br />

capsules<br />

4604 Fenistil Dimetindenum Solution for<br />

intravenous injection<br />

4 mg Novartis Consumer Health<br />

S.A.<br />

1 mg/ml Novartis Consumer Health<br />

S.A.<br />

4606 Fenkarol Fenkarol Tablets 25 mg Chemiczno —<br />

Farmaceutyczne Zakłady<br />

‘Olaines’<br />

30/11/05<br />

30/11/05<br />

31/10/04<br />

31/07/04<br />

31/07/04<br />

31/01/05<br />

31/07/05<br />

31/12/08<br />

4607 Fenobarbital Galenus, Warszawa 24/05/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 959<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4608 Fenobarbital sodowy Galenus, Warszawa 24/05/07<br />

4609 Fenol Pharma Zentrale 31/01/05<br />

4610 FENOLIP 250 Retard Fenofibratum Prolonged release<br />

capsules<br />

250 mg Betapharm Arzneimittel<br />

GmbH<br />

31/12/08<br />

4611 Fenoratio 100 Fenofibratum Capsules 100 mg ratiopharm GmbH 30/04/04<br />

4612 Fenoratio Retard Fenofibratum Prolonged release<br />

capsules<br />

4613 Fenoterol Fenoterolum Solution for injection<br />

and intravenous<br />

infusion<br />

250 mg ratiopharm GmbH 31/03/05<br />

50 mcg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4614 Fenoterol Fenoterolum Tablets 5 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

4615 Fenovax Fenofibratum Capsules 200 mg IVAX PHARMA POLAND Sp.<br />

z o.o.<br />

4616 Fenspiride Fenspiridum Syrup 2 mg / ml Farmaceutyczna Spółdzielnia<br />

Pracy ‘GALENA’<br />

4617 Fentanyl Fentanylum Solution for injection 50 mcg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/01/05<br />

31/12/05<br />

31/12/08<br />

31/12/08<br />

30/11/05<br />

4618 Fentanyl Jannsen Fentanylum Solution for injection 50 mcg/ml Janssen Pharmaceutica N.V. 30/06/04<br />

4619 Fentanyl Torrex Fentanylum Solution for injection 50 µg/ml, op.<br />

2ml<br />

4620 Fentanyl Torrex Fentanylum Solution for injection 50 µg/ml, op.<br />

10 ml<br />

Torrex Pharma GmbH 31/12/08<br />

Torrex Pharma GmbH 31/12/08<br />

4621 Fenylort ciowy azotan Pharma Cosmetic, Kraków 30/09/05<br />

4622 Fenylort ciowy boran Pharma Cosmetic, Kraków 30/09/05<br />

4623 Fenylu salicylan Pharma Zentrale 31/01/05<br />

4624 Fenylu salicylan Zakłady Farmaceutyczne<br />

Polpharma SA, Starogard<br />

Gdański<br />

4625 Fepress 10 Felodipinum Prolonged release<br />

tablets<br />

4626 Fepress 2,5 Felodipinum Prolonged release<br />

tablets<br />

4627 Fepress 5 Felodipinum Prolonged release<br />

tablets<br />

4628 Ferplex Ferri proteinatosuccinas Granules for oral<br />

suspension<br />

4629 Ferplex Ferri proteinatosuccinas Solution for<br />

oromucosal use<br />

4630 Ferran 100 Kompleks z˙elaza z<br />

dekstarnem<br />

4631 Ferran 200 Kompleks z˙elaza z<br />

dekstarnem<br />

4632 Ferrodex S Kompleks dekstranu<br />

drobnocza˛steczkowego<br />

z z˙elazem<br />

trójwartos´ciowym<br />

31/01/05<br />

10 mg HEXAL AG 31/12/08<br />

2,5 mg HEXAL AG 31/12/08<br />

5 mg HEXAL AG 31/12/08<br />

800mg (40 mg<br />

Fe+++)<br />

800mg/15ml,<br />

(40 mg Fe+++/<br />

15 ml)<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Italfarmaco S.p.A. 31/01/05<br />

Italfarmaco S.p.A. 31/01/05<br />

Vet-Agro 17/07/05<br />

Vet-Agro 17/07/05<br />

Kutnowskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

10/02/04


EN<br />

960 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4633 Ferro-Duo Ferrosi sulfas Gastro-resistant<br />

capsules, hard<br />

100 mg Fe++ Schwarz Pharma AG 20/06/07<br />

4634 Ferroglobin Preparat złoz˙ony Capsules Vitabiotics Ltd. 31/12/08<br />

4635 Ferrograd Folic Acidum folicum +<br />

Ferrosi sulfas<br />

Film-coated, slow<br />

release tablets<br />

4636 Ferro-Gradumet Ferrosi sulfas Modified release<br />

tablets<br />

4637 Ferrovet Dekstran z˙elazowy,<br />

Dekstran<br />

Liquid for veterinary<br />

use<br />

Abbott Laboratories Ltd. 31/12/08<br />

105 mg Fe++ Abbott Laboratories Ltd. 30/01/05<br />

Zakłady Farm, Biowet 31/12/08<br />

4638 Ferrum Complexe Nr 29 Tablets Lehning Laboratoires 31/12/08<br />

4639 Ferrum Lek Ferri hydroxydum<br />

polymaltosum<br />

4640 Ferrum Lek Ferri hydroxydum<br />

polymaltosum<br />

Buccal tablet 100 mg Lek Pharmaceutical &<br />

Chemical Company d.d.<br />

Syrup 50 mg/5 ml Lek Pharmaceutical &<br />

Chemical Company d.d.<br />

4641 FERRUM Pentarkan /Ptk nr 45/ DHU-Arzneimittel GmbH &<br />

Co.KG<br />

4642 Ferrum phosphoricum comp.<br />

granulki<br />

31/12/08<br />

31/12/08<br />

5/02/05<br />

WELEDA 24/08/05<br />

4643 Ferrum-Homaccord Amp. Heel GmbH 31/12/08<br />

4644 Ferrum-Homaccord Drops Heel GmbH 31/12/08<br />

4645 Ferrum-Lek Ferri hydroxydum<br />

polyisomaltosum<br />

Solution for<br />

intramuscular<br />

injection<br />

50 mg Fe+++/<br />

ml<br />

4646 Fertagyl Gonadorelinum Liquid for veterinary<br />

use<br />

4647 Fervex Acidum ascorbicum<br />

(vit C) + Paracetamolum<br />

+ Pheniraminum<br />

Lek Pharmaceuticals d.d. 31/07/04<br />

Intervet 31/12/08<br />

Granules for solution UPSA Laboratoires Agen 30/06/05<br />

4649 FERVEX Chesty Cough Ambroxolum Effervescent tablets 30 mg Bristol — Myers Squibb<br />

Pharmavit<br />

4648 FERVEX Chesty Cough Ambroxolum Tablets 30 mg Bristol — Myers Squibb<br />

Pharmavit<br />

4650 Fervex D Acidum ascorbicum<br />

(vit C) + Paracetamolum<br />

+ Pheniraminum<br />

4651 Fervex Junior Acidum ascorbicum<br />

(vit C) + Paracetamolum<br />

+ Pheniraminum<br />

Granules for oral<br />

solution<br />

Granules for oral<br />

solution<br />

31/12/08<br />

31/12/08<br />

UPSA Laboratoires Agen 14/12/05<br />

UPSA Laboratoires Agen 12/10/05<br />

4652 Feticonazole Feticonazolum Cream 2 % Medana Pharma TERPOL<br />

Group S.A.<br />

31/12/08<br />

4653 Fevarin Fluvoxaminum Film-coated tablets 100 mg Solvay Pharmaceuticals B.V. 30/04/05<br />

4654 Fevarin Fluvoxaminum Film-coated tablets 50 mg Solvay Pharmaceuticals B.V. 30/04/05<br />

4655 Fexofenadine Fexofenadinum Film-coated tablets 120 mg POL-NIL Sp. z.o.o. 31/12/08<br />

4656 Fexofenadine Fexofenadinum Film-coated tablets 180 mg POL-NIL Sp. z.o.o. 31/12/08<br />

4657 Fibisol Preparat złoz˙ony Liquid for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

Farmak 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 961<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4658 Fibranat Fenofibratum Capsules, hard 67 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4659 Fibranat Fenofibratum Capsules, hard 200 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4660 Fibro Vein 0,2 % Natrii tetradecylum<br />

sulfas<br />

4661 Fibro Vein 1 % Natrii tetradecylum<br />

sulfas<br />

4662 Fibro Vein 3 % Natrii tetradecylum<br />

sulfas<br />

4663 Fibrolan Dornasum alfa +<br />

Fibrinolysinum<br />

4664 Fibrolan Dornasum alfa +<br />

Fibrinolysinum<br />

Solution for injection 2 mg/ml STD Pharmaceutical Products<br />

Ltd.<br />

Solution for injection 10 mg/ml STD Pharmaceutical Products<br />

Ltd.<br />

Solution for injection 30 mg/ml STD Pharmaceutical Products<br />

Ltd.<br />

Lyophilisate for<br />

cutaneous liquid<br />

4665 FiBS Liquid for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

31/12/08<br />

31/12/08<br />

25/05/05<br />

25/05/05<br />

25/05/05<br />

Parke Davis GmbH 31/07/04<br />

Ointment Parke-Davis GmbH —<br />

Freiburg<br />

31/07/04<br />

OCFZP Biostymulator 31/12/08<br />

4666 figura 1 Instant herbal tea Herbapol — Lublin S.A. 31/12/08<br />

4667 figura 2 Instant herbal tea Herbapol — Lublin S.A. 31/12/08<br />

4668 Filmadine Acidum lacticum +<br />

Glycerolum +<br />

Sorbitolum<br />

4669 Filomag B6 Magnesii hydroaspartas<br />

+ Pyridoxinum (vit B6)<br />

4670 Filumar (poprzednia nazwa:<br />

ulmasol)<br />

Liquid for veterinary<br />

use<br />

Hypred 31/12/08<br />

Tablets 40 mg Mg ++ Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’, Bydgoszcz<br />

30/06/06<br />

Ulmariae tinctura Liquid Phytopharm Kle˛ka S.A. 31/12/08<br />

4671 Finadyne Solution Fluniksyna Solution for veterinary<br />

use<br />

Schering-Plough Central East<br />

Ag<br />

4672 Finalgel sport Piroxicamum Gel 5 mg/g Boehringer Ingelheim<br />

International GmbH<br />

4673 Finalgon Nicoboxilum +<br />

Nonivamidum<br />

4674 Finalgon Nicoboxilum +<br />

Nonivamidum<br />

Cream (10,8mg +<br />

1,7mg)/g<br />

Ointment (25mg +<br />

4mg)/g<br />

Boehringer Ingelheim<br />

International GmbH<br />

Boehringer Ingelheim<br />

International GmbH<br />

17/05/05<br />

16/05/07<br />

31/07/04<br />

31/07/04<br />

4675 Finaride Finasteridum Film-coated tablets 5 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

4676 Finasterid Finasteridum Tablets PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4677 Finasteride Finasteridum Film-coated tablets 5 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/12/08<br />

31/12/08<br />

4678 Finastid Finasteridum Film-coated tablets 5 mg Merck Sharp & Dohme B.V. 31/12/08<br />

4679 Fincar Finasteridum Film-coated tablets 5 mg Cipla Ltd. 31/12/08<br />

4680 Finix Ibuprofenum +<br />

Coffeinum<br />

Film-coated tablets 200 mg +<br />

50 mg<br />

US Pharmacia 31/12/08<br />

4681 Finlepsin Carbamazepinum Tablets 200 mg AWDpharma GmbH & Co.<br />

KG<br />

4682 FINLEPSIN 200 Retard Carbamazepinum Prolonged release<br />

tablets<br />

200 mg AWDpharma GmbH & Co.<br />

KG<br />

31/12/08<br />

31/12/08


EN<br />

962 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4683 FINLEPSIN 400 Retard Carbamazepinum Prolonged release<br />

tablets<br />

4684 Fiolet gencjanowy 0,5 %<br />

roztwór spirytusowy<br />

Methylrosanilinii<br />

chloridum<br />

4685 First Dose CV Koronawirus psów NL<br />

—18<br />

400 mg AWDpharma GmbH & Co.<br />

KG<br />

Liquid 5 mg/g Cefarm Gdańsk<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

Vaccine for dogs for veterinary<br />

use<br />

31/12/08<br />

30/10/05<br />

Pfizer 31/12/07<br />

4686 Fish oil Olej rybi Capsules 500 mg BIOGAL Pharmaceutical<br />

Works Ltd<br />

4687 Fitolizyna Paste for oral<br />

suspension<br />

Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4688 Fito-Mix I Herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4689 Fito-Mix I fix Instant herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4690 Fito-Mix II fix Instant herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4691 Fito-Mix II mieszanka<br />

wykrztus´na<br />

4692 Fito-Mix IV fix Melissae folium +<br />

Foeniculu fructus + Anisi<br />

fructus<br />

4693 Fito-Mix IV mieszanka<br />

mlekope˛dna<br />

Melissae folium +<br />

Foeniculu fructus + Anisi<br />

fructus<br />

Herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

Instant herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

Herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4694 Fito-Mix IX fix Instant herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4695 Fito-Mix IX mieszanka pbiegunkowa<br />

4696 Fito-Mix V mieszanka<br />

osłaniaja˛ca<br />

Herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

Herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4697 Fito-Mix VII fix Instant herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4698 Fito-Mix VII mieszanka<br />

poprawiaja˛ca trawienie<br />

Herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4699 Fito-Mix VIII fix Instant herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4700 Fito-Mix VIII mieszanka ptra˛dzikowa<br />

Herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 963<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4701 Fito-Mix X fix Instant herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4702 Fito-Mix X mieszanka<br />

przeczyszczaja˛ca<br />

Herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4703 Fito-Mix XI fix Instant herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4704 Fito-Mix XI mieszanka preumatyczna<br />

Herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4705 Fito-Mix XII fix Instant herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4706 Fito-Mix XII mieszanka<br />

z˙ółciope˛dna<br />

Herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4707 Fito-Mix XIII fix Instant herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4708 Fito-Mix XIII mieszanka<br />

moczope˛dna<br />

Herbal tea Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

4709 Fito-mix XV Herbal tea Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’<br />

4710 Fito-mix XV fix Instant herbal tea Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’,<br />

Pruszków<br />

4711 Fito-mix XVI Hippocastani semen,<br />

Calendulae flos, Sennae<br />

folium<br />

Instant herbal tea Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’,<br />

Pruszków<br />

4712 Fito-mix XVI fix Instant herbal tea Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’<br />

4713 Fito-mix XVII Crataegi inflorescentia,<br />

Cynarae folium, Allii<br />

cepae bulbus<br />

Herbal tea Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’<br />

4714 Fito-mix XVIII Preparat złoz˙ony Instant herbal tea Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’<br />

4715 Fitoplast Pach Huangshi Changzheng<br />

Pharmaceuticals Co. Ltd.<br />

4716 Fitoprost Serenoae repens fructus<br />

extractum<br />

Capsules 160 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

4717 Fitoprost Serenoae repens extr. Capsules 320 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

4718 Fitoven Preparat ziołowy Paste for oral<br />

suspension<br />

Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

31/12/08<br />

30/10/05<br />

4719 Fizostygminy salicylan Caesar & Loretz GmbH Caelo 31/12/08<br />

4720 Fizostygminy salicylan Pharma Zentrale 31/12/08


EN<br />

964 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4721 Flamexin Piroxicamum Powder for oral<br />

solution<br />

20 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4722 Flamexin Piroxicamum Tablets 20 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4723 Flammacerinum Cerii nitras +<br />

Sulfadiazinum<br />

Cream (10mg +<br />

22mg)/g<br />

17/01/07<br />

17/01/07<br />

Solvay Pharmaceuticals B.V. 18/12/06<br />

4724 Flammazine Sulfadiazinum Cream 1 % Solvay Pharmaceuticals B.V. 31/12/06<br />

4725 Flammazine Sulfadiazinum argentum Cream 10 mg/g Solvay Pharmaceuticals B.V. 31/12/06<br />

4726 Flarex Fluorometholonum Eye drops, suspension 1 % (0,01 g/<br />

1 ml)<br />

Alcon Couvreur N.V. 31/01/05<br />

4727 Flatuvit Preparat ziołowy Instant herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

4728 Flatuvit Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

4729 Flavacrin Ethacridini lactas Powder for veterinary<br />

use<br />

Drwalewskie Zakłady<br />

Przemysłu Biowet.<br />

4732 Flavamed Ambroxolum Effervescent tablets 30 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

4733 Flavamed Ambroxolum Effervescent tablets 60 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

4730 Flavamed Ambroxolum Syrup 15 mg/5 ml Berlin-Chemie AG (Menarini<br />

Group)<br />

4731 Flavamed Ambroxolum Tablets 30 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

4734 Flaven Diosminum Capsules 300 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

4735 Flavobil Ginkgo biloba Film-coated tablets 40 mg Medana Pharma Terpol<br />

Group S.A.<br />

4736 Flebogamma iv Immunoglobulinum<br />

humanum<br />

4737 Flebogamma iv Immunoglobulinum<br />

humanum<br />

4738 Flebogamma iv Immunoglobulinum<br />

humanum<br />

4739 Flebogamma iv Immunoglobulinum<br />

humanum<br />

Intravenous injection<br />

(solution)<br />

Intravenous injection<br />

(solution)<br />

Intravenous injection<br />

(solution)<br />

Intravenous injection<br />

(solution)<br />

30/10/05<br />

30/10/05<br />

24/05/04<br />

31/01/05<br />

31/01/05<br />

31/01/05<br />

31/01/05<br />

31/12/08<br />

14/03/07<br />

0.5 g/10 ml Instituto Grifols S.A. 31/12/07<br />

10 g/200 ml Instituto Grifols S.A. 31/12/07<br />

2.5 g/50 ml Instituto Grifols S.A. 31/12/07<br />

5 g/100 ml Instituto Grifols S.A. 31/12/07<br />

4740 Flector Ep Gel Diclofenacum Gel z˙el IBSA Institut Biochemique<br />

S.A.<br />

4741 Flector Ep Tissugel Diclofenacum Transdermal patch IBSA Institut Biochemique<br />

S.A.<br />

4742 Flectron cypermetryna Tag for veterinary<br />

use<br />

4743 Fleet Phospho Soda Natrii phosphas + Natrii<br />

phosphas<br />

4744 Flegafit Plantaginis lanceolatae<br />

folium+Verbasci<br />

flos+Bromhexini<br />

hydrochloricum<br />

Oral solution (24,4g +<br />

10,8g)/ 45ml<br />

31/12/08<br />

31/12/08<br />

Cyanamid 31/12/08<br />

E.C. De Witt and Company<br />

Ltd<br />

16/05/07<br />

Syrup Herbapol — Lublin S.A. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 965<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4745 Flegamina Bromhexinum Oral drops, solution 2 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4746 Flegamina Bromhexinum Solution for injection 2 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4747 Flegamina Bromhexinum Syrup 4 mg/5ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4748 Flegamina Bromhexinum Tablets 8 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4749 Flegamina Mite Bromhexinum Syrup 40 mg/100 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4750 Flexiderm Sylimarin<br />

phosphotidylcholine<br />

complex<br />

4751 Flixonase Fluticasonum Nasal spray,<br />

suspension<br />

4752 Flixonase Nasule Fluticasonum Nasal drops,<br />

suspension<br />

Ointment 10 mg/g Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

50 mcg/dawke˛ Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

400 mcg/<br />

dawke˛<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

4756 Flixotide Fluticasonum Nebuliser suspension 0.5 mg/2 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

4757 Flixotide Fluticasonum Nebuliser suspension 2 mg/2 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

4753 Flixotide Fluticasonum Pressurised inhalation,<br />

suspension<br />

4754 Flixotide Fluticasonum Pressurised inhalation,<br />

suspension<br />

4755 Flixotide Fluticasonum Pressurised inhalation,<br />

suspension<br />

4758 Flixotide 25 Fluticasonum Pressurised inhalation,<br />

suspension<br />

4759 Flixotide 50 Fluticasonum Pressurised inhalation,<br />

suspension<br />

4760 Flixotide 125 Fluticasonum Pressurised inhalation,<br />

suspension<br />

4761 Flixotide 250 Fluticasonum Pressurised inhalation,<br />

suspension<br />

125 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

250 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

50 mcg/dawke˛<br />

inhalacyjna˛<br />

25 mcg/dawke˛<br />

inhalacyjna˛<br />

50 mcg/dawke˛<br />

inhalacyjna˛<br />

125 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

250 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

4762 Flixotide Dysk Fluticasonum Inhalation powder 100 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

4763 Flixotide Dysk Fluticasonum Inhalation powder 250 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

4764 Flixotide Dysk Fluticasonum Inhalation powder 50 mcg/dawke˛<br />

inhalacyjna˛<br />

4765 Flixotide Dysk Fluticasonum Inhalation powder 500 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

30/11/05<br />

30/11/05<br />

31/01/06<br />

30/11/05<br />

31/12/08<br />

17/02/05<br />

30/09/04<br />

21/03/07<br />

27/06/07<br />

27/06/07<br />

23/11/05<br />

23/11/05<br />

23/11/05<br />

23/04/06<br />

23/04/06<br />

23/04/06<br />

23/04/06<br />

30/04/05<br />

30/04/05<br />

30/04/05<br />

30/04/05


EN<br />

966 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4766 Flixotide Rotadisk 50 Fluticasonum Inhalation powder 50 mcg/dawke˛<br />

inhalacyjna˛<br />

4767 Flixotide Rotadisk 100 Fluticasonum Inhalation powder 100 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

4768 Flixotide Rotadisk 250 Fluticasonum Inhalation powder 250 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

4769 Flixotide Rotadisk 500 Fluticasonum Inhalation powder 500 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

4770 Floam Natrii fluoridum Fluorine foam for<br />

fluorese<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

23/04/06<br />

23/04/06<br />

23/04/06<br />

23/04/06<br />

20 mg/g Germiphene Corporation 31/08/04<br />

4771 Flocrat tabletki Sanofi-Synthelabo Sp.z o.o. 31/12/08<br />

4772 Flolan Epoprostenolum Powder for solution<br />

for intravenous<br />

infusion<br />

4773 Flolan Epoprostenolum Powder for solution<br />

for intravenous<br />

infusion<br />

0,5 mg Glaxo Wellcome House,<br />

Glaxo Wellcome Group<br />

1,5 mg Glaxo Wellcome House,<br />

Glaxo Wellcome Group<br />

31/12/08<br />

31/12/08<br />

4776 Flonidan Loratadinum Oral suspension 1 mg/ml Lek Pharmaceuticals d.d. 31/12/07<br />

4777 Flonidan Loratadinum Oral suspension 1 mg/ml Lek Polska Sp. z o.o. 31/12/07<br />

4774 Flonidan Loratadinum Tablets 10 mg Lek Pharmaceuticals d.d. 31/12/07<br />

4775 Flonidan Loratadinum Tablets 10 mg Lek Polska Sp. z o.o. 31/12/07<br />

4778 Florfenicol 2,5 % płyn Florfenikol Liquid for veterinary<br />

use<br />

4779 Florfenicol 30 % iniekcja Florfenikol Solution for veterinary<br />

use<br />

4780 Floron Florfenikol Solution for veterinary<br />

use<br />

4781 Floron Oral solution Florfenikol Solution for veterinary<br />

use<br />

4782 Floron premix Florfenikol Premix for veterinary<br />

use<br />

Vetos-Farma 31/12/08<br />

Vetos-Farma 31/12/08<br />

KRKA 31/12/08<br />

KRKA 31/12/08<br />

KRKA 31/12/08<br />

4783 Flosept fix Instant herbal tea Herbapol Lublin S.A. 30/04/06<br />

4784 Flosteron Betamethasonum Suspension for<br />

injection<br />

7 mg/1 ml Krka d.d., Novo mesto 31/07/04<br />

4785 Floxal Ciprofloxacinum Film-coated tablets 250 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

4786 Floxal Ciprofloxacinum Film-coated tablets 500 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

4787 Floxal Ofloxacinum Eye drops 3 mg/g Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

4788 Floxal Ofloxacinum Eye ointment 3 mg/g Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

4789 Flualgin Fluniksyna Solution for veterinary<br />

use<br />

30/11/05<br />

31/12/08<br />

31/05/04<br />

31/05/04<br />

Bimeda 31/12/08<br />

4790 Fluanxol Flupentixolum Coated tablets 0.5 mg H. Lundbeck A/S 30/06/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 967<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4791 Fluanxol Flupentixolum Coated tablets 3 mg H. Lundbeck A/S 30/06/04<br />

4792 Fluanxol Depot Flupentixolum Solution for injection 20 mg/ml H. Lundbeck A/S 30/06/04<br />

4793 Fluarix Influenza, purified<br />

antigen<br />

Suspension for<br />

injection<br />

4794 Flubactin 20 % Flumechina Solution for veterinary<br />

use<br />

4795 Flubenol 220 mg Flubendazol Tablets for veterinary<br />

use<br />

4796 Flubenol 5 % Flubendazol Premix for veterinary<br />

use<br />

4797 Flubenol 50 % flubendazol Powder for veterinary<br />

use<br />

4798 Flubenol KH Flubendazol Paste for veterinary<br />

use<br />

GlaxoSmithKline Biologicals<br />

S.A.<br />

31/12/04<br />

KRKA 27/06/05<br />

Janssen 23/06/07<br />

Janssen Pharmaceutica 7/03/05<br />

Janssen 31/12/08<br />

Janssen 31/12/08<br />

4800 Flucinar Fluocinoloni acetonidum Gel 0.25 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

4799 Flucinar Fluocinoloni acetonidum Ointment 0.25 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

4801 Flucinar N Fluocinoloni acetonidum<br />

+ Neomycinum<br />

4802 Flucinar N Fluocinoloni acetonidum<br />

+ Neomycinum<br />

Cream (0,25mg +<br />

0,5mg)/g<br />

Ointment (0,25mg +<br />

0,5mg)/g<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

4803 Flucofungin Fluconazolum Capsules, hard 50 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

4804 Flucofungin Fluconazolum Capsules, hard 100 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

4805 Flucofungin Fluconazolum Capsules, hard 150 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

4806 Flucofungin Fluconazolum Capsules, hard 200 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

4807 Flucofungin Fluconazolum Solution for<br />

intravenous infusion<br />

4808 Flucolvet Flumechina-<br />

Kolistyny siarczan<br />

Powder for veterinary<br />

use<br />

2 mg/ml HEXAL Polska Sp. z o.o. 31/12/08<br />

Interbiowet Sp. z o.o. 16/10/06<br />

4809 Flucon Fluorometholonum Eye drops, suspension 1 mg/ml Alcon Couvreur N.V. 30/06/04<br />

4810 Fluconazol Fluconazolum Solution for<br />

intravenous infusion<br />

2 mg/ml Slovakofarma a.s. 31/12/08<br />

4811 Fluconazol 150 Fluconazolum Capsules 150 mg Slovakofarma a.s. 7/03/07<br />

4812 Fluconazol 150 Fluconazolum Capsules 150 mg Slovakofarma a.s. 7/03/07<br />

4813 Fluconazol 50 Fluconazolum Capsules 50 mg Slovakofarma a.s. 7/03/07<br />

4814 Fluconazol 50 Fluconazolum Capsules 50 mg Slovakofarma a.s. 7/03/07<br />

4815 Fluconazole Fluconazolum Capsules 150 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4816 Fluconazole Fluconazolum Capsules 150 mg Medana Pharma Terpol<br />

Group S.A.<br />

4817 Fluconazole Fluconazolum Capsules 50 mg Medana Pharma Terpol<br />

Group S.A.<br />

31/05/05<br />

31/05/05<br />

31/05/05<br />

4818 Fluconazole Fluconazolum Syrup 50 mg /10 ml Aflofarm 31/12/08


EN<br />

968 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4819 Fluconazole Fluconazolum Syrup 50 mg/10ml Polfarmex S.A 14/12/05<br />

4820 Fluconazole Fluconazolum Tablets 100 mg Polfarmex S.A 31/05/05<br />

4821 Fluconazole Fluconazolum Tablets 50 mg Polfarmex S.A 14/12/05<br />

4822 Fluconazole Fluconazolum Tablets 50 mg Aflofarm 31/12/08<br />

4823 Fluconazole Fluconazolum Tablets 50 mg Aflofarm 31/12/08<br />

4824 Fluconazole 150 Fluconazolum Capsules 150 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

4825 Fluconazole 50 Fluconazolum Capsules 50 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

6/07/05<br />

6/07/05<br />

4826 Flucoric Fluconazolum Capsules 50 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

4827 Flucoric Fluconazolum Capsules 100 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

4828 Flucoric Fluconazolum Capsules 150 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

4829 Flucoric Fluconazolum Capsules 200 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

4830 Flucozal Fluconazolum Capsules 50 mg Aegis Ltd. 31/12/08<br />

4831 Flucozal Fluconazolum Capsules 150 mg Aegis Ltd. 31/12/08<br />

4832 Fludara Fludarabinum Powder for solution<br />

for injection<br />

50 mg Schering AG 31/03/04<br />

4833 Fludara Oral Fludarabinum Tablets 10 mg Schering AG 31/12/08<br />

4835 Flugalin Flurbiprofenum Film-coated tablets 100mg Abbott GmbH & Co KG 30/06/04<br />

4836 Flugalin Flurbiprofenum Film-coated tablets 50 mg Abbott GmbH & Co KG 30/06/04<br />

4834 Flugalin Flurbiprofenum Transdermal patch 40 mg Abbott GmbH & Co KG 29/06/05<br />

4837 Flugalin SR 200 Flurbiprofenum Prolonged release<br />

capsules<br />

4838 Fluidosan Olejek terpentynowy,<br />

Nalewka z pieprzu<br />

tureckiego, Woda<br />

amoniakalna,<br />

Liquid for veterinary<br />

use<br />

200 mg Abbott GmbH & Co KG 31/12/08<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

25/05/04<br />

4842 Fluimucil Acetylcysteinum Effervescent tablets 600 mg Zambon Group S.p.A. 31/12/07<br />

4839 Fluimucil Acetylcysteinum Granules 100 mg Zambon Group S.p.A. 31/12/07<br />

4840 Fluimucil Acetylcysteinum Granules 200 mg Zambon Group S.p.A. 31/12/07<br />

4841 Fluimucil Acetylcysteinum Solution for injection<br />

and nebuliser solution<br />

4843 Fluimucil antidote 20 % Acetylcysteinum Solution for<br />

intravenous infusion<br />

4844 Flukiver 5 % inject. Klozantel Solution for veterinary<br />

use<br />

300 mg/3 ml Zambon Group S.p.A. 31/12/07<br />

200 mg/ml Zambon Group S.p.A. 31/05/05<br />

Janssen 11/06/04<br />

4845 Flukonazol Fluconazolum Syrup 5 mg / 1 ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

4846 Flumeqiuna 10 % — roztwór Flumechina Solution for veterinary<br />

use<br />

4847 Flumequina 10 % — proszek Flumechina Powder for veterinary<br />

use<br />

31/12/08<br />

Vetos Farma 16/05/06<br />

PFO Vetos Farma 16/05/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 969<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4848 Flumesol 10 % Flumechina Powder for veterinary<br />

use<br />

4849 Flumesol 5 % Flumechina Solution for veterinary<br />

use<br />

4850 Flumiquil 50 % Flumechina Powder for veterinary<br />

use<br />

4851 Flumisol Flumechina Solution for veterinary<br />

use<br />

Dopharma 14/03/05<br />

Dopharma B.V. 10/06/07<br />

Ceva Sante Animale 31/12/08<br />

Ceva Sante Animale 31/12/08<br />

4852 Flumycon Fluconazolum Capsules 150 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4853 Flumycon Fluconazolum Capsules 200 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4854 Flumycon Fluconazolum Solution for infusion 2 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4855 Flumycon, Fluconazole Fluconazolum Capsules 100 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4856 Flumycon, Fluconazole Fluconazolum Capsules 50 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4857 Flumycon, Fluconazole Fluconazolum Syrup 5 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4858 Flunarizinum Flunarizinum Tablets 5 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

4859 Flunimeg Fluniksyna Solution for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

29/03/06<br />

31/05/05<br />

31/05/05<br />

31/05/05<br />

30/06/06<br />

Norbrook 11/02/04<br />

4860 Flunitrazepam Flunitrazepamum Tablets 1 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

4861 Fluocaril Bi-Fluore 180 o<br />

smaku malinowym<br />

4862 Fluocaril Bi-Fluore 180 o<br />

smaku mie˛towym<br />

Natrii fluoridum +<br />

Natrii monofluorophosphas<br />

Natrii fluoridum +<br />

Natrii monofluorophosphas<br />

4863 Fluocaril Bi-Fluore 250 Natrii fluoridum +<br />

Natrii<br />

monofluorophosphas<br />

Toothpaste 1.8 mg<br />

fluoru/g<br />

Dental gel 1.8 mg<br />

fluoru/g<br />

Toothpaste 2.5 mg<br />

fluoru/g<br />

Synthelabo Group.<br />

Laboratoires Synthelabo<br />

Synthelabo Group.<br />

Laboratoires Synthelabo<br />

Synthelabo Group.<br />

Laboratoires Synthelabo<br />

4864 Fluogum (o smaku mie˛towym) Natrii fluoridum Chewing gum 0.25 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

4865 Fluogum (o smaku<br />

owocowym)<br />

Natrii fluoridum Chewing gum 0.25 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

4866 Fluoksetyna Fluoxetinum Syrup 20 mg/5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

4867 Fluoksetyna Fluoxetinum Tablets 10 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

4868 Fluoksetyna Fluoxetinum Tablets 20 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/12/08<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

31/01/05<br />

31/01/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

4869 Fluonor Fluoxetinum Capsules 20 mg Norton Healthcare Ltd. 31/12/08<br />

4870 Fluoresceina Caesar & Loretz GmbH Caelo 5/09/05


EN<br />

970 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4871 Fluoresceine Fluoresceinum Solution for injection 100 mg/ml Novartis Ophthalmics AG<br />

Hettlingen<br />

31/07/04<br />

4872 Fluorescite Fluoresceinum Solution for injection 100 mg/ml Alcon Laboratoires Inc. 30/06/04<br />

4873 Fluoridin Dental lacquer VOCO GmbH 31/12/07<br />

4875 Fluormex Gel 12.5 mg<br />

fluoru/g<br />

Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

4874 Fluormex Liquid 10 mg fluoru/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

4876 Fluoro-uracil Fluorouracilum Solution for injection<br />

and intravenous<br />

infusion<br />

4877 Fluorouracil 1000 medac Fluorouracilum Solution for<br />

intravenous injection,<br />

intravenous and<br />

intraarterial infusion<br />

4878 Fluorouracil 500 medac Fluorouracilum Solution for<br />

intravenous injection,<br />

intravenous and<br />

intraarterial infusion<br />

4879 Fluorouracil 5000 medac Fluorouracilum Solution for<br />

intravenous injection,<br />

intravenous and<br />

intraarterial infusion<br />

4880 FLUOROURACIL 750 Medac Fluorouracilum Solution for<br />

intravenous injection,<br />

intravenous and<br />

intraarterial infusion<br />

4881 Fluorouracil Therabel 250 Fluorouracilum Solution for<br />

intravenous and<br />

intraarterial injection<br />

4882 Fluorouracil Therabel 500 Fluorouracilum Solution for<br />

intravenous and<br />

intraarterial injection<br />

30/10/05<br />

30/10/05<br />

50 mg/ml ICN Polfa Rzeszów S.A. 31/01/05<br />

50 mg/ml medac Gesellschaft fur<br />

Klinische Spezialpraparate<br />

mbH<br />

50 mg/ml medac Gesellschaft fur<br />

Klinische Spezialpraparate<br />

mbH<br />

50 mg/ml medac Gesellschaft fur<br />

Klinische Spezialpraparate<br />

mbH<br />

50 mg/1 ml medac Gesellschaft für<br />

klinische Spezialpräparate<br />

mbH<br />

250 mg/10ml Therabel Pharma S.A.<br />

(Therabel Group)<br />

500 mg/10 ml Therabel Pharma S.A.<br />

(Therabel Group)<br />

4883 Fluorouracil-Teva Fluorouracilum Amp. 250 mg/5 ml Teva Pharmaceutical<br />

Industries<br />

4884 Fluorouracil-Teva Fluorouracilum Amp. 500 mg/10 ml Teva Pharmaceutical<br />

Industries<br />

4888 Fluorouracil-Teva Fluorouracilum Intravenous infusion 5 g/100 ml Teva Pharmaceutical<br />

Industries<br />

4885 Fluorouracil-Teva Fluorouracilum Vial 250 mg/5 ml Teva Pharmaceutical<br />

Industries<br />

4886 Fluorouracil-Teva Fluorouracilum Vial 500 mg/10 ml Teva Pharmaceutical<br />

Industries<br />

4887 Fluorouracil-Teva Fluorouracilum Vial 1 g/20 ml Teva Pharmaceutical<br />

Industries<br />

4889 Fluoro-z˙el Natrii fluoridum +<br />

Natrii monofluorophosphas<br />

Oromucosal gel (11mg +<br />

114mg)/g<br />

Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

31/03/05<br />

31/03/05<br />

31/03/05<br />

31/12/08<br />

8/02/06<br />

8/02/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/10/05<br />

4890 Fluossen Natrii fluoridum Coated tablets 6.78 mg F ICN Polfa Rzeszów S.A. 31/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 971<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4891 Fluoxetin Fluoxetinum Capsules 20 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

4892 Fluoxetine Fluoxetinum Capsules 20 mg Teva Pharmaceutical<br />

Industries<br />

4893 Fluoxetine Fluoxetinum Tablets 20 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

4894 Fluran Fluoxetinum Capsules 20 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

4895 Flutacan Flutamidum Tablets 250 mg Leiras Oy 31/12/07<br />

4896 Flutamerck Flutamidum Tablets 250 mg Generics (UK) Limited 31/12/08<br />

4897 Flutamid Flutamidum Tablets 250 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/12/05<br />

4898 Flutaratio Flutamidum Tablets 250 mg ratiopharm GmbH 12/09/07<br />

4899 Flutetrin Oksytetracyklina,<br />

fluniksyna<br />

4900 Fluvac EHV 4/1Plus Szczepionka dla koni<br />

przeciw zakaz˙eniom<br />

górnych dróg<br />

oddechowych<br />

4901 Fluvac Plus Szczepionka dla koni<br />

przeciw zakaz˙eniom<br />

górnych dróg<br />

oddechowych<br />

4902 Fluviral S/F Vaccinum influenzae Suspension for<br />

injection<br />

4903 Fluviral S/F Vaccinum influenzae Suspension for<br />

injection<br />

4904 Fluvirin Influenza, inactivated,<br />

whole virus<br />

Solution for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for<br />

intramuscular oraz<br />

deep subcutaneous<br />

injection<br />

4905 Fluxum Parnaparinum natricum Solution for<br />

subcutanous injection<br />

4906 Fluxum Parnaparinum natricum Solution for<br />

subcutanous injection<br />

4907 Fluxum Solution for<br />

subcutanous injection<br />

4908 FMC Formacor Formaldehyd, Zieleń<br />

malachitowa, Błe˛kit<br />

metylenowy<br />

4909 FMC Formacor Forte Zieleń malachitowa,<br />

Błe˛kit metylenowy,<br />

Aldehyd mrówkowy<br />

0,5 ml<br />

(szczepionka 1<br />

— dawkowa)<br />

0,5 ml<br />

(szczepionka<br />

10 —<br />

dawkowa)<br />

45 mcg HA/<br />

0,5 ml<br />

3200 j.m. AXa/<br />

0,3ml<br />

6400 j.m. AXa/<br />

0,6ml<br />

4250 j.m. AXa/<br />

0,4 ml<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Bimeda 31/12/08<br />

Fort Dodge 3/09/04<br />

Fort Dodge 3/09/04<br />

Shire Biologics 31/12/08<br />

Shire Biologics 31/12/08<br />

Medeva Pharma Ltd.<br />

Leatherhead<br />

31/12/08<br />

Alfa Wassermann S.p.A. 26/04/06<br />

Alfa Wassermann S.p.A. 26/04/06<br />

Alfa Wassermann S.p.A. 26/04/06<br />

Przedsiebiorstwo Tropical 31/12/08<br />

Przedsiebiorstwo Tropical 18/09/07<br />

4910 Folacid Acidum folicum Tablets 15 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

4911 Folacid Acidum folicum Tablets 5 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

29/08/07<br />

29/08/07


EN<br />

972 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4912 Folacid 0,4 Acidum folicum Tablets 0,4 mg Przedsie˛biorstwo<br />

Farmaceutyczno —<br />

Chemiczne ‘Synteza’ Sp.<br />

z o.o.<br />

31/12/08<br />

4913 Folifem Acidum folicum Buccal tablet 0,4 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

4914 Folifort 15 Acidum folicum Film-coated tablets 15 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

4915 Folifort 5 Acidum folicum Film-coated tablets 5 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

4916 Folik Acidum folicum Tablets 0.4 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

4917 Folimin 0,4 mg Acidum folicum Tablets 0.4 mg Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

4918 Folimin 15mg Acidum folicum Tablets 15mg Zakłady Farmaceutyczne<br />

Polfa- Łódz˙ S.A.<br />

4919 Folimin 4mg Acidum folicum Tablets 4mg Zakłady Farmaceutyczne<br />

Polfa- Łódz˙ S.A.<br />

4920 Folligon Gonadotropina z<br />

surowicy cie˛z˙arnych<br />

klaczy<br />

4921 Foradil Formoterolum Inhalation powder,<br />

capsules<br />

Lyophilisate + solvent for veterinary<br />

use<br />

4922 Foramed Formoterolum Capsules 12<br />

mikrogramów<br />

4923 Forane Isofluranum Pressurised inhalation,<br />

solution<br />

30/09/05<br />

4/07/07<br />

30/09/07<br />

30/09/07<br />

Intervet 31/12/08<br />

12 mcg Novartis Pharma AG 31/12/08<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

31/12/08<br />

Abbott Laboratories Ltd. 31/05/04<br />

4924 Forcan Fluconazolum Capsules 200 mg Cipla Ltd. 31/12/08<br />

4925 Forcan Fluconazolum Capsules 50 mg Cipla Ltd. 31/12/08<br />

4926 Forcan Fluconazolum Capsules 150 mg Cipla Ltd. 31/12/08<br />

4927 Forcid Solutab® 125/31,25 Amoxicillinum +<br />

Acidum clavulanicum<br />

4928 Forcid Solutab® 250/62,5 Amoxicillinum +<br />

Acidum clavulanicum<br />

4929 Forcid Solutab® 375/93,75 Amoxicillinum +<br />

Acidum clavulanicum<br />

4930 FORCID SOLUTAB®<br />

500/125 X<br />

Amoxicillinum +<br />

Acidum clavulanicum<br />

4931 Forlax Macrogol, combinations Powder for oral<br />

suspension<br />

Tablets 125 mg +<br />

31,25 mg<br />

Tablets 250 mg +<br />

62,5 mg<br />

Tablets 375 mg +<br />

93,75 mg<br />

Tablets 125 mg +<br />

31,25 mg<br />

Yamanouchi Europe B.V. 31/12/08<br />

Yamanouchi Europe B.V. 31/12/08<br />

Yamanouchi Europe B.V. 31/12/08<br />

Yamanouchi Europe B.V. 31/12/08<br />

Beaufour Ipsen Pharma 31/12/08<br />

4932 Formadehyd 40 % Zakład Farmaceutyczny<br />

Amara, Kraków<br />

9/04/05<br />

4933 Formaldehyd 40 % Pharma Cosmetic, Kraków 31/12/08<br />

4934 Formaldehyd 40 % Pharma Zentrale 31/12/08<br />

4935 Formaldehyd 40 % Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

4936 Formaldehyd 40 % PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 973<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4937 Formaldehyd 40 % Przedsie˛biorstwo Chmiczne<br />

Odczynniki Sp. z o.o., Lublin<br />

31/12/08<br />

4938 Formic rufa compose krople Dolisos Laboratoires 31/12/08<br />

4939 Formol Formoterolum Inhalation powder,<br />

capsule<br />

10ug GENEXO Sp.z.o.o Warszawa 31/12/08<br />

4940 Fort- E -Vite Tocopherolum Capsules 100 j.m G.R. Lane Health Products<br />

Ltd.<br />

30/04/04<br />

4941 Fortakehl D3 Sanum-Kehlbeck 31/12/05<br />

4942 Fortakehl D5 Sanum-Kehlbeck 31/12/05<br />

4943 Fortalgin C Acidum acetylsalicylicum<br />

+ Acidum ascorbicum<br />

(vit C)<br />

4944 Fortekor 20 Benazeprilum Tablet for veterinary<br />

use<br />

4945 Fortekor 5 Benazeprilum Tablet for veterinary<br />

use<br />

4946 Fortestomachicae(poprzednia<br />

nazwa:krople z˙oła˛dkowe p)<br />

Effervescent tablets Lek Pharmaceuticals d.d. 31/12/07<br />

Novartis Animal Health Inc. 30/06/04<br />

Novartis Animal Health Inc. 30/06/04<br />

Preparat złoz˙ony Oral drops Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

4947 Fortovase Saquinavirum Capsules, soft 200 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

31/12/08<br />

31/07/04<br />

4948 Fortral Pentazocinum Solution for injection 30 mg/ml Krka d.d., Novo mesto 31/05/05<br />

4949 Fortral Pentazocinum Tablets 50 mg Krka d.d., Novo mesto 31/05/05<br />

4950 Fortrans Powder for oral<br />

solution<br />

4955 Fortum Ceftazidimum Dry substance for<br />

intravascular and<br />

intramuscular<br />

injection<br />

4956 Fortum Ceftazidimum Dry substance for<br />

intravascular and<br />

intramuscular<br />

injection<br />

4957 Fortum Ceftazidimum Dry substance for<br />

intravascular and<br />

intramuscular<br />

injection<br />

4958 Fortum Ceftazidimum Dry substance for<br />

intravascular and<br />

intramuscular<br />

injection<br />

4951 Fortum Ceftazidimum Powder for solution<br />

for intravascular and<br />

intramuscular<br />

injection<br />

4952 Fortum Ceftazidimum Powder for solution<br />

for intravascular and<br />

intramuscular<br />

injection<br />

4953 Fortum Ceftazidimum Powder for solution<br />

for intravascular<br />

injection and infusion<br />

Beaufour Ipsen Pharma 30/06/07<br />

1 g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

2 g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

250 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

500 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

500 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

250 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

2 g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

30/10/05<br />

30/04/04<br />

30/04/04<br />

30/04/04


EN<br />

974 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4954 Fortum Ceftazidimum Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

4959 Fortzaar (Hyzaar Forte) Losartanum +<br />

Hydrochlorothiazidum<br />

Film-coated tablets 100 mg +<br />

25 mg<br />

1 g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Merck Sharp & Dohme Idea<br />

Inc.<br />

4960 Fosamax Acidum alendronicum Tablets 5 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

4961 Fosamax 10 Acidum alendronicum Tablets 10 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

4962 Fosamax 70 Acidum alendronicum Tablets 70 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

30/04/04<br />

31/12/08<br />

14/03/07<br />

15/07/06<br />

21/06/06<br />

4963 Foscarnet Foscarnetum Cream 2 % Instytut Farmaceutyczny 31/12/08<br />

4964 Foscarnet Foscarnetum Solution for infusion 6 g /250 ml Instytut Farmaceutyczny 31/12/08<br />

4965 Foscarnet Foscarnetum Solution for infusion 12 g /500 ml Instytut Farmaceutyczny 31/12/08<br />

4966 Fostimon Urofollitropinum Lyophilisate for<br />

solution for<br />

intramuscular<br />

injection<br />

4967 Fotil Pilocarpinum +<br />

Timololum<br />

4968 Fotil Pilocarpinum +<br />

Timololum<br />

4969 Fotil Forte Pilocarpinum +<br />

Timololum<br />

4970 Fotil Forte Pilocarpinum +<br />

Timololum<br />

Eye drops, solution (20mg + 5mg)/<br />

ml<br />

Eye drops, solution (20mg + 5mg)/<br />

ml<br />

Eye drops, solution (40mg + 5mg)/<br />

ml<br />

Eye drops, solution (40mg + 5mg)/<br />

ml<br />

4971 Foxverm Pyrantelu winian Syrup for veterinary<br />

use<br />

4973 Fragmin Dalteparinum natricum Solution for<br />

subcutaneous<br />

injection<br />

4974 Fragmin Dalteparinum natricum Solution for<br />

subcutaneous,<br />

intravascular injection<br />

or intravenous<br />

infusion<br />

4975 Fragmin Dalteparinum natricum Solution for<br />

subcutaneous,<br />

intravascular injection<br />

or intravenous<br />

infusion<br />

4972 Fragmin Dalteparinum natricum Solution for<br />

subcutanous injection<br />

4976 Fragmin Natrium dalteparinum Solution for<br />

subcutanous injection<br />

4977 Fragmin Natrium dalteparinum Solution for<br />

subcutanous injection<br />

75 IU IBSA Institut Biochemique<br />

S.A.<br />

2500 j.m./<br />

0,2 ml (anty<br />

Xa)<br />

10000 j.m./<br />

1 ml (anty Xa)<br />

10000 j.m./<br />

4 ml (anty Xa)<br />

5000 j.m./<br />

0,2 ml (anty<br />

Xa)<br />

10000 j.m./<br />

0,4 ml (anty<br />

Xa)<br />

12500 j.m./<br />

0,5 ml (antyXa)<br />

31/12/08<br />

Santen Oy 30/06/07<br />

Santen Oy 30/06/07<br />

Santen Oy 12/10/05<br />

Santen Oy 12/10/05<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

29/04/04<br />

Pharmacia A.B. 31/12/08<br />

Pharmacia N.V./S.A. 31/12/08<br />

Pharmacia N.V./S.A. 31/12/08<br />

Pharmacia A.B. 31/12/08<br />

Pharmacia A.B. 27/06/07<br />

Pharmacia A.B. 27/06/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 975<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4978 Fragmin Natrium dalteparinum Solution for<br />

subcutanous injection<br />

4979 Fragmin Natrium dalteparinum Solution for<br />

subcutanous injection<br />

4980 Fragmin Natrium dalteparinum Solution for<br />

subcutanous injection<br />

4987 Fraxiparine Nadroparinum calcicum Solution for<br />

subcutaneous and<br />

intravascular injection<br />

4988 Fraxiparine Nadroparinum calcicum Solution for<br />

subcutaneous and<br />

intravascular injection<br />

4981 Fraxiparine Nadroparinum calcicum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

4982 Fraxiparine Nadroparinum calcicum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

4983 Fraxiparine Nadroparinum calcicum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

4984 Fraxiparine Nadroparinum calcicum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

4985 Fraxiparine Nadroparinum calcicum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

4986 Fraxiparine Nadroparinum calcicum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

4989 Fraxiparine Multi Nadroparinum calcicum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

4990 Fraxiparine Multi Nadroparinum calcicum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

4991 Fraxodi Nadroparinum calcicum Solution for<br />

subcutanous injection<br />

4992 Fraxodi Nadroparinum calcicum Solution for<br />

subcutanous injection<br />

4993 Fraxodi Nadroparinum calcicum Solution for<br />

subcutanous injection<br />

15000 j.m./<br />

0,6 ml (anty<br />

Xa)<br />

18000 j.m./<br />

0,72 ml (anty<br />

Xa)<br />

7500 j.m./<br />

0,3 ml (anty<br />

Xa)<br />

3800 j.m./<br />

0,4 ml<br />

7600 j.m./<br />

0,8 ml<br />

2850 j.m./<br />

0,3 ml<br />

2850 j.m./<br />

0,3 ml<br />

5700 j.m./<br />

0,6 ml<br />

5700 j.m./<br />

0,6 ml<br />

Pharmacia AB 27/06/07<br />

Pharmacia A.B. 27/06/07<br />

Pharmacia & Upjohn AB-<br />

Stockholm<br />

27/06/07<br />

Sanofi-Synthelabo France 30/06/07<br />

Sanofi-Synthelabo France 30/06/07<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/10/05<br />

Sanofi Winthrop-Gentilly 30/04/04<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/10/05<br />

Sanofi Winthrop-Gentilly 30/04/04<br />

9500 j.m./1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/10/05<br />

9500 j.m./1 ml Sanofi Winthrop-Gentilly 30/04/04<br />

142500 j.m.<br />

Axa/15ml<br />

47500 j.m.<br />

Axa/5ml<br />

11400 j.m.<br />

AXa/0,6ml<br />

15200 j.m.<br />

AXa/0,8 ml<br />

19000 j.m.<br />

AXa/1 ml<br />

Sanofi Winthrop-Gentilly<br />

Cedex<br />

Sanofi Winthrop-Gentilly<br />

Cedex<br />

31/05/05<br />

31/05/05<br />

Sanofi Winthrop-Gentilly 6/07/05<br />

Sanofi Winthrop-Gentilly 6/07/05<br />

Sanofi Winthrop-Gentilly 6/07/05<br />

4994 Freederm Tar Shampoo Shampoo Schering-Plough Farma Lda 31/05/04<br />

4995 Freederm Zinc Shampoo Shampoo Schering-Plough Farma Lda 31/05/04<br />

4996 Fresubin Diabetes Alimentation liquid 380 kJ/100 ml Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

4997 Fresubin HP energy Liquid Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

31/12/08<br />

31/08/04


EN<br />

976 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

4998 Fresubin Original Fibre Liquid Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

4999 Fresubin original o smaku<br />

czekoladowym<br />

5000 Fresubin original o smaku<br />

waniliowym<br />

Alimentation liquid 420 kJ/100 ml Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

Alimentation liquid 420 kJ/100 ml Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

5001 Frisium 10 Clobasamum Tablets 10 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

5002 Fromilid Clarithromycinum Granules for oral<br />

suspension<br />

30/06/07<br />

31/12/08<br />

31/12/08<br />

30/06/04<br />

125 mg/5ml Krka d.d., Novo mesto 31/08/05<br />

5003 Fromilid 250 Clarithromycinum Film-coated tablets 250 mg Krka d.d., Novo mesto 31/12/08<br />

5004 Fromilid 500 Clarithromycinum Film-coated tablets 500 mg Krka d.d., Novo mesto 31/12/08<br />

5005 Frontin Alprazolamum Tablets 0.25 mg Egis Pharmaceuticals Ltd. 27/09/06<br />

5006 Frontin Alprazolamum Tablets 0.5 mg Egis Pharmaceuticals Ltd. 27/09/06<br />

5007 Frontin Alprazolamum Tablets 1 mg Egis Pharmaceuticals Ltd. 27/09/06<br />

5008 Frontline Spot-On Fipronil Solution for veterinary<br />

use<br />

5009 Frontline Spray Fipronil Spray for veterinary<br />

use<br />

5010 FructiCal 200 Calcii carbonas Buccal tablet 500 mg<br />

(200mg Ca++)<br />

5012 FructiCal 200 Calcii carbonas Buccal tablet 500 mg<br />

(200mg Ca++)<br />

5013 FructiCal 200 Calcii carbonas Buccal tablet 500 mg<br />

(200mg Ca++)<br />

5014 FructiCal 200 Calcii carbonas Buccal tablet 500 mg<br />

(200mg Ca++)<br />

5011 FructiCal 200 Calcii carbonas Buccal tablet 500 mg<br />

(200mg Ca++)<br />

5015 FSME-Bulin Encephalitis, tick borne<br />

immunoglobulin<br />

(Immunoglobulina<br />

przeciw wczesnoletniemu<br />

kleszczowemu zapaleniu<br />

opon mózgowych i<br />

mózgu)<br />

5016 FSME-Immun Inject Encephalitis, tick borne<br />

immunoglobulin<br />

(Vaccinum encephalitidis<br />

ixodibus)<br />

Solution for<br />

intramuscular<br />

injection<br />

Suspension for<br />

intramuscular<br />

injection<br />

100 do<br />

170 mg/ml<br />

białka<br />

ludzkiego<br />

(m.in.. 90 %<br />

gamma<br />

globuliny)<br />

2-3,5mcg<br />

antygenu<br />

wirusa kzm<br />

Merial SAS 17/10/07<br />

Merial 9/06/05<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/03/06<br />

31/03/06<br />

31/03/06<br />

31/03/06<br />

31/03/06<br />

Baxter AG 31/03/04<br />

Baxter Vaccine AG 29/02/04<br />

5017 Ftorafur Tegafurum Capsules 400 mg Public Joint Stock Company<br />

‘Grindex’<br />

5018 Fuchsoral Szczepionka<br />

przeciwko ws´ciekliz´nie<br />

dla lisów wolno<br />

z˙yja˛cych (blister<br />

zatopiony w<br />

przyne˛cie) do<br />

podawania doustnego<br />

Suspension for veterinary<br />

use<br />

Impfstoffwerk Dessau-Tornau<br />

GmbH<br />

31/12/08<br />

25/03/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 977<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5019 Fuchsoral Szczepionka<br />

przeciwko ws´ciekliz´nie<br />

dla lisów wolno<br />

z˙yja˛cych (blister<br />

zatopiony w<br />

przyne˛cie) do<br />

podawania doustnego<br />

Suspension for veterinary<br />

use<br />

Biowet Puławy Spółka z o.o. 22/11/06<br />

5020 Fucidin Acidum fusidicum Cream 20 mg/g Leo Pharmaceuticals Products 30/06/07<br />

5021 Fucidin Acidum fusidicum Ointment 20 mg/g Leo Pharmaceuticals Products 30/06/07<br />

5024 Fucidin Acidum fusidicum Oral suspension 50 mg/ml Leo Pharmaceuticals Products 30/06/07<br />

5022 Fucidin Acidum fusidicum Powder and solvent<br />

for concentrate for<br />

solution for<br />

intravenous infusion<br />

50 mg/ml Leo Pharmaceuticals Products 30/06/07<br />

5023 Fucidin Acidum fusidicum Tablets 250 mg Leo Pharmaceuticals Products 30/06/07<br />

5025 Fucus Complexe Lehning<br />

nr 111<br />

5026 Fucus-Dagomed 17<br />

odchudzanie<br />

Tablets Lehning Laboratoires 11/11/06<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

5027 Fugerel Flutamidum Tablets 250 mg Schering-Plough Labo N.V. 31/05/04<br />

5028 Fulsed Midazolamum Solution for<br />

intravenous and<br />

intramuscular<br />

injection<br />

5029 Fulsed Midazolamum Solution for<br />

intravenous and<br />

intramuscular<br />

injection<br />

5030 Fungiderm Klotrymazol Solution for veterinary<br />

use<br />

5031 Fungidermin Klotrymazol Ointment for veterinary<br />

use<br />

1 mg/ml Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

5 mg/ml Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego S.A.<br />

14/12/05<br />

14/12/05<br />

21/05/04<br />

30/06/05<br />

5032 Fungores Ketoconazolum Tablets 200 mg ICN Polfa Rzeszów S.A. 30/04/05<br />

5033 Funlak Ciclopiroxum Nail lacquer 80 mg / g Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

31/12/08<br />

5034 Furaginum Furaginum Tablets 50 mg Adamed Sp. z o.o. 31/01/05<br />

5035 Furaginum Furaginum Tablets 50 mg Olaińskie Zakłady<br />

Chemiczno-Farmaceutyczne<br />

‘OlainFarm’<br />

5036 Furamag Furaginum Capsules 50 mg Olaińskie Zakłady Chemiczno<br />

— Farmaceutyczne<br />

‘OlainFarm’<br />

5037 Furanef Furaginum Tablets 50 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

5038 Furazolidon Furazolidonum Oral suspension 17 mg/5ml Medana Pharma Terpol<br />

Group S.A.<br />

5039 Furorese 250 Furosemidum Solution for<br />

intravenous injection<br />

250 mg/<br />

250 ml<br />

25/05/05<br />

31/12/08<br />

31/12/08<br />

30/10/05<br />

HEXAL AG 31/12/08<br />

5040 Furosemid Furosemidum Tablets 40 mg Labpharm Sp. z o.o. 31/12/08


EN<br />

978 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5041 Furosemidum Furosemidum Solution for injection 10 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

5042 Furosemidum Furosemidum Tablets 40 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

30/10/05<br />

5043 Furosemidum Furosemidum Tablets 40 mg Polfarmex S.A. 30/10/05<br />

5044 Furox 125 Furosemidum Tablets 125 mg HEXAL AG 31/12/08<br />

5045 Furox 20 Furosemidum Solution for<br />

intravenous and<br />

intramuscular<br />

injection<br />

10 mg/ml HEXAL AG 31/12/08<br />

5046 Furox 40 Furosemidum Tablets 40 mg HEXAL AG 31/12/08<br />

5047 Fybogel orange Plantaginis ovatae testa Effervescent granules 3.5 g Reckitt&Colman Products<br />

Limited<br />

30/06/04<br />

5048 Gabapentin Gabapentinum Capsules 100 mg POLFA KUTNO S.A. 31/12/08<br />

5049 Gabapentin Gabapentinum Capsules 300 mg POLFA KUTNO S.A. 31/12/08<br />

5050 Gabapentin Gabapentinum Capsules 400 mg POLFA KUTNO S.A. 31/12/08<br />

5051 GABAPENTIN 100 mg Gabapentinum Capsules 100 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5052 GABAPENTIN 300 mg Gabapentinum Capsules 300 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5053 GABAPENTIN 400 mg Gabapentinum Capsules 400 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5054 GABAPENTIN 600 mg Gabapentinum Film-coated tablets 600 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5055 GABAPENTIN 800 mg Gabapentinum Film-coated tablets 800 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

5056 Gabapentin Torrex Gabapentin Capsules 100 mg Torrex Pharma GmbH 31/12/08<br />

5057 Gabapentin Torrex Gabapentin Capsules 300 mg Torrex Pharma GmbH 31/12/08<br />

5058 Gabapentin Torrex Gabapentin Capsules 400 mg Torrex Pharma GmbH 31/12/08<br />

5059 Gabax Gabapentinum Capsules 100 mg Norton Healthcare Ltd. 27/06/07<br />

5060 Gabax Gabapentinum Capsules 300 mg Norton Healthcare Ltd. 27/06/07<br />

5061 Gabax Gabapentinum Capsules 400 mg Norton Healthcare Ltd. 27/06/07<br />

5062 Gabbrocol 100 Paromomycyny<br />

siarczan<br />

5063 Gabbrocol Injection Paromomycyny<br />

siarczan<br />

Powder for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

5064 Gabbrostim Alfaprostol Solution for veterinary<br />

use<br />

5065 Gabbrovital B Forte Tiaminy chlorowodorekPirydoksyny<br />

chlorowodorek-<br />

Nikotynamid<br />

Solution for veterinary<br />

use<br />

Vetem S.p.A. 21/02/06<br />

Vetem S.p.A. 26/02/06<br />

VETEM 4/03/04<br />

Vetem S.p.A. 21/02/06<br />

5066 Gabitril Tiagabinum Film-coated tablets 10 mg Sanofi Winthrop-Gentilly 31/12/08<br />

5067 Gabitril Tiagabinum Film-coated tablets 15 mg Sanofi Winthrop-Gentilly 31/12/08<br />

5068 Gabitril Tiagabinum Film-coated tablets 5 mg Sanofi Winthrop-Gentilly 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 979<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5069 Gadovist 1,0 Gadobutrolum Solution for<br />

intravenous injection<br />

604.72 mg/ml Schering AG 9/08/06<br />

5070 Galantamine Galantaminum Film-coated tablets 4 mg POLFA KUTNO S.A. 31/12/08<br />

5071 Galantamine Galantaminum Film-coated tablets 8 mg POLFA KUTNO S.A. 31/12/08<br />

5072 Galantamine Galantaminum Film-coated tablets 12 mg POLFA KUTNO S.A. 31/12/08<br />

5073 Galastop Kabergolina Solution for veterinary<br />

use<br />

5074 Galenobaza Cutaneous emulsion Cefarm Gdańsk<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

5075 Galimune SE Szczepionka<br />

przeciwko zakaz˙eniom<br />

Salmonella enteritidis<br />

dla kur<br />

Emulsion for veterinary<br />

use<br />

Vetem 22/10/04<br />

22/02/06<br />

Merial 31/12/08<br />

5076 Galium-Heel N Amp. Heel GmbH 31/12/07<br />

5077 Galium-Heel N Drops Heel GmbH 31/12/07<br />

5078 Gallemolan forte Capsules Julius Redel CESRA —<br />

Arzneimittelfabrik GmbH<br />

5079 Gallimune 201 IBD+REO Inaktywowana<br />

szczepionki dla kur<br />

przeciwko zakaz´nemu<br />

zapalenia torby<br />

Fabrycjusza,<br />

reowirusowemu<br />

zapalenia stawów i<br />

pochewek<br />

s´cie˛gnowych<br />

5080 Gallimune 403<br />

ND+IB+IBD+REO<br />

5081 Gallium (67ga) Citrate<br />

Injection<br />

Inaktywowana<br />

szczepionki dla kur<br />

przeciwko rzekomemu<br />

pomorowi drobiu,<br />

zakaz´nemu zapalenia<br />

oskrzeli, zakaz´nemu<br />

zapalenia torby<br />

Fabrycjusza,<br />

reowirusowemu<br />

zapalenia stawów i<br />

pochewek<br />

s´cie˛gnowych<br />

Preparat<br />

radiofarmaceutyczny<br />

5082 Gallivac IB 88 Szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu oskrzeli<br />

5083 Gallivac IBD Szczepionka przeciw<br />

chorobie Gumboro dla<br />

kur<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

31/12/06<br />

Merial Italia SPA-SS 24/05/07<br />

Merial Italia SPA-SS 24/05/07<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Merial SAS 22/05/06<br />

Merial 7/05/04<br />

5084 Galocard Acidum acetylsalicylicum Tablets 100 mg Farmaceutyczno-Chemiczna<br />

Spółdzielnia Pracy GALENUS<br />

5085 Galomega Omega-3-trójglicerydy Capsules, soft 350 mg Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

5086 Galospa Drotraverini<br />

hydrochloridum<br />

Tablets 40 mg Farmaceutyczno —<br />

Chemiczna Spółdzielnia Pracy<br />

Galenus<br />

30/04/05<br />

30/04/05<br />

10/10/05


EN<br />

980 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5087 Galstena Drops Richard Bittner 9/09/07<br />

5088 Gal-Vit Capsules 0.35 g Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

5089 Gambrosol 10 H Roztwór glukozy i<br />

elektrolitów<br />

5090 Gambrosol 10 L Roztwór glukozy i<br />

elektrolitów<br />

5091 Gambrosol 10 M Roztwór glukozy i<br />

elektrolitów<br />

Solution for<br />

peritoneum dialysis<br />

Solution for<br />

peritoneum dialysis<br />

Solution for<br />

peritoneum dialysis<br />

5092 Gambrosol 40 H Solution for<br />

peritoneum dialysis<br />

5093 Gambrosol 40 L Solution for<br />

peritoneum dialysis<br />

5094 Gambrosol 40 M Solution for<br />

peritoneum dialysis<br />

5095 Gambrosol Tri 10 Preparat złoz˙ony Kit: 3 solution for<br />

solution for<br />

peritonuem dialysis<br />

5096 Gambrosol Tri 40 Preparat złoz˙ony Kit: 3 solution for<br />

solution for<br />

peritonuem dialysis<br />

5097 Gamimune N 5 % Immunoglobulinum<br />

humanum<br />

5098 Gamimune N 10 % Immunoglobulinum<br />

humanum<br />

5099 Gamma anty D 50 Anti-D (rh)<br />

immunoglobulinum<br />

5100 Gamma anty D 150 Anti-D (rh)<br />

immunoglobulinum<br />

5101 Gamma anty HBs 200 Immunoglobulinum<br />

humanum<br />

5102 Gamma anty HBs 1000 Immunoglobulinum<br />

humanum<br />

5103 Gamma Globulina ludzka Immunoglobulinum<br />

humanum<br />

5104 Gamma Globulina Ludzka Immunoglobulinum<br />

humanum<br />

5105 Gammagard S/D Immunoglobulinum<br />

humanum<br />

5106 Gammagard S/D Immunoglobulinum<br />

humanum<br />

5107 Gammagard S/D Immunoglobulinum<br />

humanum<br />

5108 Gammagard S/D Immunoglobulinum<br />

humanum<br />

Intravenous injection<br />

(solution for infusion)<br />

Intravenous injection<br />

(solution for infusion)<br />

Solution for<br />

intramuscular<br />

injection<br />

Solution for<br />

intramuscular<br />

injection<br />

Solution for<br />

intramuscular<br />

injection<br />

Solution for<br />

intramuscular<br />

injection<br />

Solution for<br />

intramuscular<br />

injection<br />

Solution for<br />

intramuscular<br />

injection<br />

Lyophilisate for<br />

intravenous infusion<br />

Lyophilisate for<br />

intravenous infusion<br />

Lyophilisate for<br />

intravenous infusion<br />

Lyophilisate for<br />

intravenous infusion<br />

31/12/08<br />

Gambro Lundia AB 10/04/06<br />

Gambro Lundia AB 10/04/06<br />

Gambro Lundia AB 10/04/06<br />

Gambro Lundia AB 31/12/04<br />

Gambro Lundia AB 31/12/04<br />

Gambro Lundia AB 31/12/04<br />

Gambro Lundia AB 31/12/08<br />

Gambro Lundia AB 31/12/08<br />

50 mg/ml Bayer Corporation 31/12/07<br />

0.1 g/ml Bayer Corporation 31/12/07<br />

50 mcg Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

15 mcg Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

200 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

1000 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

150 mg/ml Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

150 mg/ml Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

0.5 g Baxter Healthcare<br />

Corporation Hyland Immuno<br />

10 g Baxter Healthcare<br />

Corporation Hyland Immuno<br />

2.5 g Baxter Healthcare<br />

Corporation Hyland Immuno<br />

5 g Baxter Healthcare<br />

Corporation Hyland Immuno<br />

30/09/05<br />

30/09/05<br />

30/09/05<br />

30/09/05<br />

30/09/05<br />

30/09/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 981<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5109 Gamma-Venin P Immunoglobulinum<br />

humanum<br />

Lyophilisate and<br />

solvent for solution<br />

for injection and<br />

intravascular infusion<br />

5110 Ganadexil Enrofloxacina 10 % Enrofloxacinum Solution for veterinary<br />

use<br />

5111 Ganadexil Enrofloxacina 5 % Enrofloxacinum Solution for veterinary<br />

use<br />

5112 Ganadol Acidum<br />

acetylsalicylicum<br />

Powder for veterinary<br />

use<br />

50 mg/ml Centeon Pharma GmbH 30/04/04<br />

INVESA 31/12/08<br />

INVESA 31/12/08<br />

Fatro 31/12/08<br />

5113 Ganaton Itopridum Tablets 50 mg Abbott Laboratories Poland<br />

Sp. z o.o.<br />

5114 Ganavit pharmaton Coffeinum, Guaranae<br />

extr. sicc.<br />

Effervescent tablets 42 mg +<br />

150 mg<br />

5116 Garamycin Gentamicinum Solution for<br />

intravenous and<br />

intramuscular<br />

injection or for<br />

infusion<br />

31/12/08<br />

Pharmaton S.A. 31/12/08<br />

40 mg/ml Schering-Plough Labo N.V. 31/05/04<br />

5115 Garamycin Gentamicinum Sponge 130 mg Schering-Plough NV/S.A. 30/04/04<br />

5117 Garasone Betamethasonum +<br />

Gentamicinum<br />

5118 Garasone Betamethasonum +<br />

Gentamicinum<br />

5119 Gardan P Metamizolum natricum<br />

+ Propyphenazonum<br />

5120 Gardopyrin Acidum acetylsalicylicum,<br />

Acidum ascorbicum,<br />

Coffeinum<br />

5121 Gardovit Preparat witaminowo —<br />

mineralny z dodatkiem<br />

korzenia z˙eńszenia i<br />

kofeiny<br />

Eye drops Schering-Plough Labo N.V. 31/07/05<br />

Eye ointment Schering-Plough Labo N.V. 24/01/06<br />

Tablets 300mg +<br />

200mg<br />

5122 Gargarin Powder for gargle<br />

solution<br />

5123 Gargarin Powder for gargle<br />

solution<br />

Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

Effervescent tablet N.P. Pharma Sp. z o.o. 31/12/08<br />

Effervescent tablets N.P. Pharma Sp. z o.o. 31/12/08<br />

Cefarm Lublin S.A.<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

31/01/06<br />

Farmina Sp. z o.o. 31/01/06<br />

5124 Gargarisma prophylacticum Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/07<br />

5125 Gargarisma prophylacticum Farmina Sp. z o.o., Kraków 31/12/07<br />

5126 Gargarisma prophylacticum Maggie, Warszawa 31/12/07<br />

5127 Gargarisma prophylacticum Prolab, Paterek k/Nakła 31/12/07<br />

5128 Gargarisma prophylacticum PZF ‘Cefarm-Lublin’ S.A. 31/12/07<br />

5129 Gargarisma prophylacticum Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

5130 Gargaroten fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp.<br />

z o.o. — Zastawna<br />

31/12/07<br />

30/10/05<br />

5131 Garlepa Dr Dunner 31/12/08


EN<br />

982 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5132 Garmastan Ointment Protina GmbH 31/12/08<br />

5134 Gas Simeticonum Buccal tablets 80 mg US Pharmacia 31/12/08<br />

5133 Gas Simeticonum Capsules 80 mg US Pharmacia 31/12/08<br />

5135 Gasec — 10 Gastrocaps Omeprazolum Capsules 10 mg Mepha PL Sp. z o.o. 31/12/08<br />

5136 Gasec-20 Gastrocaps Omeprazolum Capsules 20 mg Mepha Ltd. 31/07/04<br />

5137 Gasprid Cisapridum Tablets 10 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

5138 Gasprid Cisapridum Tablets 5 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

5139 Gastal Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

Oral suspension Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5140 Gastal Buccal tablets Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5142 Gastal Max Ranitidinum<br />

hydrochloridum<br />

5141 Gastal Max Ranitidinum<br />

hydrochloridum<br />

5144 Gastal Max Forte Ranitidinum<br />

hydrochloridum<br />

5143 Gastal Max Forte Ranitidinum<br />

hydrochloridum<br />

5145 Gastal O Smaku Mie˛towym Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

5146 Gastal O Smaku<br />

Pomarańczowym<br />

Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

5148 Gastal O Smaku Wis´niowym Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

5147 Gastal O Smaku Wis´niowym Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

Effervescent tablets 75 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Tablets 75 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Effervescent tablets 150 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Tablets 150 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Suspension (900 mg +<br />

600 mg)<br />

Suspension (900 mg +<br />

600 mg )/<br />

10 ml<br />

Suspension (900mg +<br />

600mg)/10 ml<br />

Tablets 450mg +<br />

300mg<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/07<br />

26/04/06<br />

30/04/05<br />

30/04/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

5149 Gastranin Ranitidinum Effervescent tablets 150 mg NP. Pharma Sp. z o.o. 31/12/08<br />

5150 Gastricumeel Tablets Heel GmbH 31/12/08<br />

5151 Gastrimine Herbal tea Herbaflos, Płońsk 31/12/08<br />

5152 Gastrina Herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

5153 Gastrina Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

5154 Gastrinal Aluminii natrii<br />

dihydroxycarbonas<br />

Buccal tablets 340 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

5155 Gastro Preparat złoz˙ony Tablets Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

5156 Gastrobin Magnesii silicas Buccal tablet 0.5 g Divapharma-Knufinke<br />

Arzneimittelwerk GmbH<br />

31/12/04<br />

31/12/04<br />

31/01/06<br />

31/01/06<br />

31/12/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 983<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5157 Gastrobonisan Herbal tea Laboratorium Medycyny<br />

Naturalnej ‘BONIMED’,<br />

Z˙ywiec<br />

5158 Gastrobonisan Herbal tea Bonimed Laboratorium<br />

Medycyny Naturalnej<br />

5159 Gastrobonisol Oral solution Bonimed Laboratorium<br />

Medycyny Naturalnej<br />

5160 Gastrochol Preparat złoz˙ony Capsules, hard Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

5/07/05<br />

5/07/05<br />

5/03/06<br />

31/12/08<br />

5161 Gastrocynesine Tablets Laboratoires BOIRON 31/12/07<br />

5162 Gastrofan Calcii carbonas +<br />

Magnesii carbonas<br />

Buccal tablet 680mg +<br />

80mg<br />

Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

5163 Gastrogalen Preparat ziołowy Oral drops Cefarm Gdańsk<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

5164 Gastrografin Natrii amidotrizoas Oral and rectal<br />

solution<br />

26/06/07<br />

27/09/06<br />

Schering AG 27/09/06<br />

5165 Gastrogran Herbal granules Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

5166 Gastrogran Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’<br />

5167 Gastrolit Sole rehydratacyjne powder for solution Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

5168 Gastromal Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

Oral suspension Polon — Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

5169 Gastronax 10 Cisapriclum Tablets 10 mg Farmaceutyczna Spółdzielnia<br />

Pracy ‘GALENA’<br />

5170 Gastronax 5 Cisapriclum Tablets 5 mg Farmaceutyczna Spółdzielnia<br />

Pracy ‘GALENA’<br />

5171 Gastronervit Herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

8/02/06<br />

26/09/07<br />

26/09/07<br />

31/12/07<br />

5172 Gastronorm Buccal tablets Herbapol — Lublin S.A. 31/12/08<br />

5173 Gastronorm Suspension Herbapol — Lublin S.A. 31/12/08<br />

5174 Gastro-Pasc krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

30/11/05<br />

5175 Gastrosan fix Instant herbal tea Herbapol Lublin S.A. 30/10/05<br />

5176 Gastrosil Simeticonum Capsules 40 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

5177 Gastrosil Simeticonum Oral drops, emulsion 66.67 mg/ml ICN Polfa Rzeszów S.A. 15/11/06<br />

5178 Gastrosol Preparat ziołowy Oral drops Cefarm Lublin S.A.<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

5179 Gastrotrombina 10000 Thrombinum Lyophilisate and<br />

solvent for oral<br />

solution<br />

10000 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

17/01/07<br />

30/10/05


EN<br />

984 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5180 Gastrotrombina 5000 Thrombinum Lyophilisate and<br />

solvent for oral<br />

solution<br />

5000 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

5181 Gastrovit Preparat ziołowy Instant herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

30/10/05<br />

30/06/07<br />

5182 Gastrovit Bional Pharma BV 30/06/07<br />

5183 Gealcid Acidum alginicum +<br />

Aluminii hydroxidum +<br />

Natrii hydrocarbonas<br />

Tablets 350mg +<br />

100mg +<br />

120mg<br />

5184 Gelafundin Solution for<br />

intravenous infusion<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/12/05<br />

30 mg/ml B. Braun Melsungen AG 31/01/05<br />

5185 Gelatum Aluminii phosphorici Aluminii phosphas Oral suspension 45 mg/g VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

5186 Gelatum Aluminii phosphorici Aluminii phosphas Oral suspension 45 mg/g Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

5187 Gelatum Aluminii Phosphorici<br />

— Forte<br />

5188 Gelatum Aluminii phosphorici<br />

4,5 %<br />

5189 Gelofusine Frakcjonowana<br />

sukcynyloz˙elatyna<br />

Aluminii phosphas Oral suspension 90 mg/g Przedsie˛biorstwo<br />

Farmaceutyczne ‘Ziołolek’ Sp.<br />

z o.o.<br />

Aluminii phosphas Oral suspension 45 mg/g Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

31/12/04<br />

31/12/04<br />

31/12/08<br />

30/10/05<br />

Solution for infusion B.Braun Medical AG 27/09/06<br />

5190 Gelsemium comp. Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

5191 Gelsemium comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

5192 Gelsemium Complexe Nr 70 Drops Lehning Laboratoires 31/12/08<br />

5193 Gelsemium-Homaccord Amp. Heel GmbH 31/12/08<br />

5194 Gelsemium-Homaccord Drops Heel GmbH 31/12/08<br />

5195 Gelules de papayer Capsules Laboratoires des Hautes<br />

Synerg.<br />

5196 Gelules de reine des pres Laboratoires des Hautes<br />

Synerg.<br />

5197 Gemcitabin Gemcitabinum Lyophilisate for<br />

solution for injection<br />

200mg i<br />

1000mg<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5198 Gemfibral Gemfibrozilum Film-coated tablets 300 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

5199 Gemfibral Gemfibrozilum Film-coated tablets 450 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

5200 Gemipar 125 Paracetamolum Suppository 125 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

5201 Gemipar 50 Paracetamolum Suppository 50 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

5202 Gemipar 500 Paracetamolum Suppository 500 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

5203 Gemiprom Ibuprofenum Film-coated tablets 200 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

5204 Gemzar Gemcitabinum Powder for solution<br />

for intravenous<br />

injections<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

4/07/06<br />

4/07/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

1 g Lilly France S.A. 10/12/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 985<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5205 Gemzar Gemcitabinum Powder for solution<br />

for intravenous<br />

injections<br />

5206 Gencjana 2 % roztwór wodny Methylrosanilinii<br />

chloridum<br />

200 mg Lilly France S.A. 10/12/06<br />

Coutanous liquid 20 mg/g Augmed 31/01/06<br />

5207 Gencydo 0.1 % amp. WELEDA 24/08/05<br />

5208 Gencydo 1 % amp. WELEDA 24/08/05<br />

5209 Gencydo 3 % amp. WELEDA 24/08/05<br />

5210 Gencydo 5 % amp. WELEDA 24/08/05<br />

5211 Gencydo 7 % amp. WELEDA 24/08/05<br />

5212 Gencydo Mas´ć WELEDA 24/08/05<br />

5213 Gencydo Płyn do u ytku zewn. WELEDA 24/08/05<br />

5214 Gengraf Ciclosporinum Capsules, hard 100 mg Abbott Laboratories Ltd. 14/03/07<br />

5215 Gengraf Ciclosporinum Capsules, hard 25 mg Abbott Laboratories Ltd. 14/03/07<br />

5216 Gengraf Ciclosporinum Capsules, hard 50 mg Abbott Laboratories Ltd. 14/03/07<br />

5217 Gengraf Ciclosporinum Oral solution 100 mg/ml Abbott Laboratories Ltd. 14/03/07<br />

5218 Genotropin 16 Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

5219 Genotropin 36 Somatropinum Lyophilisate for<br />

solution for<br />

subcutaneous<br />

injection<br />

5221 Genotropin 4 Somatropinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

5220 Genotropin 4 Somatropinum Lyophilisate for<br />

solution for<br />

subcutaneous<br />

injection<br />

5222 Genotropin MiniQuick Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

5223 Genotropin MiniQuick Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

5224 Genotropin MiniQuick Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

5225 Genotropin MiniQuick Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

5226 Genotropin MiniQuick Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

5<strong>227</strong> Genotropin MiniQuick Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

16 j.m. (5,3mg) Pharmacia A.B. 3/06/06<br />

36 j.m. (12 mg) Pharmacia A.B. 31/12/08<br />

4 j.m. (1,3mg) Pharmacia A.B. 30/06/04<br />

4 j.m. (1,3mg) Pharmacia AB 31/12/08<br />

0.6 j.m. Pharmacia A.B. 21/03/07<br />

1.2 j.m. Pharmacia A.B. 21/03/07<br />

1.8 j.m. Pharmacia A.B. 21/03/07<br />

2.4 j.m Pharmacia A.B. 21/03/07<br />

3 j.m. Pharmacia A.B. 21/03/07<br />

3.6 j.m. Pharmacia A.B. 21/03/07


EN<br />

986 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5228 Genotropin MiniQuick Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

5229 Genotropin MiniQuick Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

5230 Genotropin MiniQuick Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

5231 Genotropin MiniQuick Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

5232 Gensulin M10 (10/90) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5233 Gensulin M10 (10/90) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5234 Gensulin M20 (20/80) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5235 Gensulin M20 (20/80) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5236 Gensulin M30 (30/70) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5237 Gensulin M30 (30/70) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5238 Gensulin M30 (30/70) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5239 Gensulin M40 (40/60) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5240 Gensulin M40 (40/60) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5241 Gensulin M50 (50/50) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5242 Gensulin M50 (50/50) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

5243 Gensulin N Insulinum isophanum Suspension for<br />

injection<br />

5244 Gensulin N Insulinum isophanum Suspension for<br />

injection<br />

5245 Gensulin N Insulinum isophanum Suspension for<br />

injection<br />

4.2 j.m. Pharmacia A.B. 21/03/07<br />

4.8 j.m. Pharmacia A.B. 21/03/07<br />

5.4 j.m. Pharmacia A.B. 21/03/07<br />

6 j.m. Pharmacia A.B. 21/03/07<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

40 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

40 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

5246 Gensulin R Insulini injectio neutralis Solution for injection 100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

5247 Gensulin R Insulini injectio neutralis Solution for injection 100 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

5248 Gensulin R Insulini injectio neutralis Solution for injection 40 j.m./ml Bioton Sp. z o.o. 23/11/05<br />

5249 Genta 5 % pro.inj. Gentamicinum Solution for veterinary<br />

use<br />

Vetimex 31/12/08<br />

5250 Gentamicin Gentamicinum Eye ointment 0.3 % Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

5251 Gentamicin Gentamicinum Solution for<br />

intramuscular<br />

injection<br />

10 mg/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 987<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5252 Gentamicin Gentamicinum Solution for<br />

intramuscular<br />

injection<br />

5253 Gentamicin Gentamicinum Solution for<br />

intramuscular<br />

injection<br />

5254 Gentamicin Gentamicinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

5255 Gentamicin Gentamicinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

5256 Gentamicin Gentamicinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

5257 Gentamicin Gentamicinum Solution for<br />

intramuscular or<br />

intravenous injection<br />

5258 Gentamicin Gentamicinum Solution for<br />

intravenous and<br />

intramuscular<br />

injection and for<br />

infusion<br />

5259 Gentamicin Gentamicinum Soluble powder for veterinary<br />

use<br />

5260 Gentamicin Gentamicinum Solution for veterinary<br />

use<br />

20 mg/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

40 mg/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/05<br />

31/01/05<br />

10 mg/1ml Lek Pharmaceuticals d.d. 30/04/04<br />

20 mg/1ml Lek Pharmaceuticals d.d. 30/04/04<br />

40 mg/ml Lek Pharmaceuticals d.d. 30/04/04<br />

40 mg/ml Biochemie GmbH — Kundl 30/04/04<br />

40 mg/ml Krka d.d., Novo mesto 30/04/04<br />

Lek Pharmaceutical and<br />

Chemical Company d.d.<br />

Lek Pharmaceutical &<br />

Chemical Company<br />

5261 Gentamicin 0,3 % Gentamicinum Eye drops, solution 3 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

5262 Gentamicin 0,3 % Gentamycyna Eye drops Warszawskie Zkłady<br />

Farmaceutyczne ‘Polfa’<br />

5262 Gentamicin 0,3 % Gentamycyna Eye drops for veterinary<br />

use<br />

Warszawskie Zkłady<br />

Farmaceutyczne ‘Polfa’<br />

5263 Gentamicin P Gentamicinum Solution Lek Pharm. and Chemical<br />

Company<br />

5263 Gentamicin P Gentamicinum Solution for veterinary<br />

use<br />

5264 Gentamox Amoxicillinum +<br />

Gentamicinum<br />

Suspension for veterinary<br />

use<br />

Lek Pharm. and Chemical<br />

Company<br />

27/06/05<br />

10/05/05<br />

30/11/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Laboratorios Hipra S.A. 16/04/07<br />

5265 Gentamycin Gentamicinum Cream 1 mg/g Pharmachim-Holding AD 30/04/04<br />

5267 Gentamycin Gentamicinum Eye ointment 3 mg/g Pharmachim-Holding AD 31/07/04<br />

5266 Gentamycin Gentamicinum Ointment 1 mg/g Pharmachim-Holding AD 30/04/04<br />

5268 Gentamycin Gentamicinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

5269 Gentamycin Gentamicinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

10 mg/ml Pharmachim-Holding AD 30/04/05<br />

40 mg/ml Pharmachim-Holding AD 30/04/05


EN<br />

988 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5270 Gentamycyna 5 % Inj. Gentamicinum Solution for veterinary<br />

use<br />

Biowet Puławy Sp. z o.o. 19/09/06<br />

5271 Gentamycyny siarczan BUFA b.v. Pharmaceutical<br />

Products<br />

30/11/05<br />

5272 Gentamycyny siarczan Pharma Cosmetic, Kraków 30/11/05<br />

5273 Gentamycyny siarczan PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

5274 Gentamytrex Gentamicinum Eye drops, solution 5 mg/ml Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

5275 Gentaveto Gentamicinum Solution for veterinary<br />

use<br />

30/11/05<br />

8/05/06<br />

VMD 25/03/07<br />

5276 Genteal Hypromellosum Eye drops 3 mg/ml Novartis Ophthalmics AG 31/12/08<br />

5277 Gentiana comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

5278 Gentodiar Z˙el Gentamicinum Gel for veterinary<br />

use<br />

Intervet International B.V. 31/12/08<br />

5279 Gentos krople Richard Bittner 31/01/06<br />

5280 Geomycin F Oxytetracyclinum Tablet for veterinary<br />

use<br />

5281 Geomycin retard Oxytetracyclinum Solution for veterinary<br />

use<br />

5282 Geotilin P. Oksytetracyklina,<br />

tiamulina<br />

Premix for veterinary<br />

use<br />

Veterina Animal Health Ltd. 11/02/04<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne<br />

12/09/05<br />

Veterina 31/12/08<br />

5283 Geracep Allii cepae bulbus Film-coated tablets 150 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

23/11/05<br />

5284 Geralen Methoxsalenum Capsules 20 mg Gerot Pharmazeutika GmbH 31/07/04<br />

5285 Geratam Piracetamum Film-coated tablets 800 mg Medial Polska Sp. z o.o. 31/12/08<br />

5286 Geratam Piracetamum Film-coated tablets 1200 mg Medial Polska Sp. z o.o. 31/12/08<br />

5287 Geriabolen fix. Species<br />

geriatricae<br />

Herbal tea Eldex-Medical 31/12/06<br />

5288 Geriabolen. Species geriatricae Herbal tea Eldex-Medical 31/12/06<br />

5289 Geriacaps Allii sativi bulbus +<br />

Ginkgo bilobae xtractum<br />

siccum<br />

5290 Geriasol (na soku wisniowym) Magnesii gluconas +<br />

Magnesii lactoglubionas<br />

+ Zinci gluconas<br />

5291 Geriasol (na soku z aronii) Magnesii gluconas +<br />

Magnesii lactoglubionas<br />

+ Zinci gluconas<br />

Capsuels, hard Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

Syrup Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

Syrup Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

14/03/07<br />

31/01/05<br />

31/01/05<br />

5292 Geriatrix Effervescent tablets N.P. Pharma Sp. z o.o. 31/12/08<br />

5293 Geriavit Pharmaton Prep. Witaminowy z<br />

minerałami, kofeina˛ i<br />

wycia˛giem z korzenia z˙eń<br />

— szenia<br />

Capsules Pharmaton S.A. 30/04/04<br />

5294 Geriax Tablets VITAMEX AB 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 989<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5295 Geronpol Preparat złoz˙ony Capsules, soft Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/08<br />

5296 Gerovital Syrup N.P. Pharma Sp. z o.o. 31/12/08<br />

5299 Gestar Megestrolum Suspension 40 mg / ml Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

5297 Gestar Megestrolum Tablets 160 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

5298 Gestar Megestrolum Tablets 40 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

5300 Gestavet Gonadotropinum Lyophilisate + solvent for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Laboratorios Hipra S.A. 24/05/07<br />

5301 Gesterol Megestrolum Tablets 40 mg; 160 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

31/12/08<br />

5302 Gestomikron Medroxyprogesteronum Tablets 10 mg Adamed Sp. z o.o. 31/12/08<br />

5303 Gestomikron Medroxyprogesteronum Tablets 5 mg Adamed Sp. z o.o. 31/12/08<br />

5304 Gevilon Gemfibrozilum Film-coated tablets 450 mg Parke Davis GmbH 31/07/04<br />

5305 Gevilon Gemfibrozilum Film-coated tablets 450 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

5306 Gilucor 160mg Sotalolum Tablets 160 mg Solvay Pharmaceuticals<br />

GmbH<br />

5307 Gilucor 80mg Sotalolum Tablets 80 mg Solvay Pharmaceuticals<br />

GmbH<br />

5308 Gilurytmal 10 Ajmalinum Intravenous injection 5 mg/ml Solvay Pharmaceuticals<br />

GmbH<br />

5309 Gincosan Ginkgo bilobae folium<br />

extractum + Ginseng<br />

radix extractum<br />

30/10/05<br />

9/11/05<br />

9/11/05<br />

31/03/04<br />

Capsules Pharmaton S.A. 31/07/04<br />

5310 Gingium Solution HEXAL AG 31/12/08<br />

5311 Gingium Film-coated tablets HEXAL AG 31/12/08<br />

5312 Gingko biloba Capsules, hard 180 mg Power Health Products Ltd.,<br />

United Kingdom<br />

31/12/08<br />

5313 Gingkocard Phytopharm Kle˛ka S.A. 31/12/08<br />

5314 Ginjal Film-coated tablets Ikong Pharmaceutical<br />

Industry Co.<br />

5315 Ginkgo biloba Ginkgo bilobae<br />

extractum siccum +<br />

Ginkgo bilobae folium<br />

5316 Ginkgobil Ginkgo bilobae folium<br />

extractum siccum<br />

Capsules, hard 60 mg +<br />

270 mg<br />

30/04/04<br />

PRO NATURA s.j. 31/12/08<br />

Liquid Phytopharm Kle˛ka S.A. 31/12/08<br />

5317 Ginkgocard Preparat ziołowy Liquid Phytopharm Kle˛ka S.A. 31/12/08<br />

5318 Ginkgofol Ginkgo biloba extract Tablets 40 mg Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

5319 Ginkgomax Ginkgo bilobae<br />

extractum siccum<br />

31/12/08<br />

Film-coated tablets 60 mg Dansk Droge A/S 31/12/08


EN<br />

990 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5320 Ginkgo-mix Sp. NOVA, Swarze˛dz 31/12/08<br />

5321 Ginkgo-mix plus Sp. NOVA, Swarze˛dz 31/12/08<br />

5322 Ginkoba Ginkgo biloba Film-coated tablets 40 mg Boehringer Ingelheim<br />

International GmbH<br />

5323 Ginkocaps Ginkgo bilobae<br />

extractum siccum<br />

5324 Ginkocrategi Crataegi tinctura +<br />

Ginkgo bilobae tinctura<br />

Capsules, hard 40 mg Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Oral solution K.Z.Z. ‘Herbapol’ S.A. w<br />

Krakowie<br />

31/01/05<br />

31/12/08<br />

31/12/08<br />

5325 Ginkofar Ginkgo biloba Film-coated tablets 40 mg P.P.H.U. Biofarm Sp. z o.o. 1/08/06<br />

5326 Ginkofar Ginkgo bilobae extr.<br />

sicc., Ginkgo bilobae<br />

tinct.<br />

Oral drops P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

5327 Ginkofar forte Ginkgo biloba Film-coated tablets 80 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

27/09/06<br />

5328 Ginkofar® vita-plus Preparat złoz˙ony Film-coated tablets P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

5329 Ginkor Fort Ginkgo biloba,<br />

Troxerutinum,<br />

Heptaminoli<br />

hydrochloridum<br />

Capsules Beaufour Ipsen International 31/12/08<br />

5330 Ginkovital Ginkgo biloba Film-coated tablets 60 mg Vitamex AB 30/06/04<br />

5331 Ginsamix Preparat ziołowy Instant herbal tea Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

5333 Ginsana G 115 Ginseng radix extractum<br />

spissum<br />

5332 Ginsana G 115 Ginseng radix extractum<br />

spissum<br />

5334 Ginsana G 115 Ginseng radix extractum<br />

spissum<br />

27/09/06<br />

Buccal tablet 50 mg Pharmaton S.A. 30/04/04<br />

Capsules 0.1 g Pharmaton S.A. 30/04/04<br />

Tonik 9.3 mg/ml Pharmaton S.A. 30/04/04<br />

5335 Ginsanal Liquid Phytopharm Kle˛ka S.A. 31/12/08<br />

5336 Ginselin Ginseng radix extracum<br />

siccum<br />

5337 Ginsencaps Ginseng radix extractum<br />

siccum<br />

Film-coated tablets 107.14 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

Capsule, hard 50 mg Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

14/02/07<br />

31/12/08<br />

5338 Ginseng compositum N Drops Heel GmbH 31/12/07<br />

5339 Ginseng tonic Central Pharmaceutical<br />

Factory, Wietnam<br />

5340 Ginsengcha Ginseng radix extracum<br />

siccum<br />

5341 Ginsengin 200 Ginseng radix extractum<br />

spissum<br />

5342 Ginsengin 400 Ginseng radix extractum<br />

spissum<br />

5343 Ginsengin 600 Ginseng radix extractum<br />

spissum<br />

Granules for oral<br />

solution<br />

300 mg/3 g Yanbion Baidon Shan,<br />

Ginseng Company<br />

Oral solution 20 mg/ml The Third Pharmaceutical<br />

Manufactory<br />

31/12/08<br />

30/06/05<br />

25/05/05<br />

Oral solution 40 mg/ml Meheco 25/05/05<br />

Oral solution 60 mg/ml Meheco 25/05/05<br />

5344 Ginsengin C 200 Oral solution Implad. Cams. Experimental<br />

Medicine Factory<br />

25/05/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 991<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5345 Ginsengpian Herb 2 g/6,67g Yanbion Baidon Shan,<br />

Ginseng Company<br />

5346 Ginsenicum forte Ginseng radix extractum<br />

fluidum<br />

5347 Ginsenovit Z˙eńszeń Tablets for veterinary<br />

use<br />

5348 Ginsepan Ginseng radix extractum<br />

siccum<br />

5350 Givalex Hexetidinum +<br />

Chlorbutalum +<br />

Cholini salicylas<br />

5349 Givalex Hexetidinum +<br />

Chlorbutalum +<br />

Cholini salicylas<br />

5351 Glamin Roztwór aminokwasów i<br />

dwupeptydów<br />

31/08/05<br />

Oral solution NP. Pharma Sp. z o.o. 31/12/08<br />

Biowet Puławy 31/12/08<br />

Film-coated tablets 100 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

Oromucosal solution Norgine Pharma 31/12/08<br />

Oromucosal spray Norgine Pharma 31/12/08<br />

Solution for<br />

intravenous infusion<br />

Fresenius Kabi AB Uppsala 31/12/08<br />

5352 Glaprost Terazosinum Tablets 1mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5353 Glaprost Terazosinum Tablets 2 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5354 Glaprost Terazosinum Tablets 10 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5355 Glaprost Terazosinum Tablets 5 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5356 Glaveral Omeprazolum Film-coated capsules 20 mg Help S.A. Pharmaceuticals<br />

Attica<br />

5357 Glazide Gliclazidum Tablets 80 mg Farmaceutyczna Spółdzielnia<br />

Pracy ‘GALENA’<br />

5358 Gleptosil Z˙elazo Solution for veterinary<br />

use<br />

5359 Gletvax 6 Szczepionka przeciw<br />

kolibakteriozie s´wiń i<br />

zakaz´nemu<br />

martwicowemu<br />

zapaleniu jelit prosia˛t<br />

Suspension for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Ceva Sante Animale 31/12/08<br />

Schering-Plough Central East<br />

Ag<br />

18/09/05<br />

5360 Gliatilin Cholini alphosceras Capsules 400 mg Italfarmaco S.p.A. 30/06/04<br />

5361 Gliatilin 1000 Cholini alphosceras Solution for injection 250 mg/ml Italfarmaco S.p.A. 30/06/04<br />

5362 Glibenese Glipizidum Tablets 5 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

5363 Glibenese GITS Glipizidum Film-coated, prologed<br />

release tablets<br />

5364 Glibenese GITS Glipizidum Film-coated, prologed<br />

release tablets<br />

30/06/04<br />

10 mg Pfizer S.A. — Amboise 31/12/08<br />

5 mg Pfizer S.A. — Amboise 31/12/08<br />

5365 Glicerol 86 % Cefarm Cze˛stochowa 15/01/06<br />

5366 Glicerol 86 % Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

15/01/06<br />

5367 Glicerol 86 % Maga-Herba s.c., Legionowo 15/01/06<br />

5368 Gliceryna Aflofarm Farmacja Polska,<br />

Pabianice<br />

19/01/05


EN<br />

992 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5369 Gliceryna Avena, Bydgoszcz 19/01/05<br />

5370 Gliceryna Cefarm Gdańsk 19/01/05<br />

5371 Gliceryna Elissa, Warszawa 19/01/05<br />

5372 Gliceryna Farmina Sp. z o.o., Kraków 19/01/05<br />

5373 Gliceryna Galenus, Rzeszów 19/01/05<br />

5374 Gliceryna Hasco-Lek, Wrocław 19/01/05<br />

5375 Gliceryna Infarm, Gdynia 19/01/05<br />

5376 Gliceryna Lefarm, Bydgoszcz 19/01/05<br />

5377 Gliceryna Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

19/01/05<br />

5378 Gliceryna Pampa, Piaseczno 19/01/05<br />

5379 Gliceryna Pharma Cosmetic, Kraków 19/01/05<br />

5380 Gliceryna Pharma Zentrale 19/01/05<br />

5381 Gliceryna PPF GEMI, Karczew 19/01/05<br />

5382 Gliceryna PZF ‘Cefarm-Lublin’ S.A. 19/01/05<br />

5383 Gliceryna Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

19/01/05<br />

5384 Gliceryna AUGMED, Dawidy Bankowe 30/06/05<br />

5385 Gliclazide Gliclazidum Tablets 80 mg Generics (UK) Limited 25/05/05<br />

5386 Glicyna Glycinum Bladder irrigation 2 % Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

5387 Glicyna 1,5 % Glycinum Solution for irrigation 15 mg/ml Baxter Terpol Sp. z o.o. 14/02/07<br />

5388 Gliklazyd Gliclazidum Tablets 80 mg Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

5389 Glimepiride Glimepiridum Tablets 1 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

5390 Glimepiride Glimepiridum Tablets 1 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5391 Glimepiride Glimepiridum Tablets 4 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

5392 Glimepiride Glimepiridum Tablets 2 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5393 Glimepiride Glimepiridum Tablets 3 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5394 Glimepiride Glimepiridum Tablets 4 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5395 Glimepirode Glimepiridum Tablets 3 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/08/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

5396 Glimepiryd Glimepiridum Tablets 1 mg POLFA KUTNO S.A. 31/12/08<br />

5397 Glimepiryd Glimepiridum Tablets 2 mg POLFA KUTNO S.A. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 993<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5398 Glimepiryd Glimepiridum Tablets 3 mg POLFA KUTNO S.A. 31/12/08<br />

5399 Glimepiryd Glimepiridum Tablets 4 mg POLFA KUTNO S.A. 31/12/08<br />

5400 Glimeryl Glimepiridum Tablets 3 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

5401 Glimeryl Glimepiridum Tablets 4 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

5402 Glimeryl Glimepiridum Tablets 1 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

5403 Glimeryl Glimepiridum Tablets 2 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

5404 Glimpiride Glimepiridum Tablets 2 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

5405 Glinormax Gliclazidum Prolonged release<br />

tablets<br />

80 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

5406 Glinowo-potasowy siarczan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

5407 Glinu siarczan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

5408 Gliper Glimepiridum Tablets 4 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

5409 Gliper Glimepiridum Tablets 3 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

5410 Gliper Glimepiridum Tablets 2 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

5411 Gliper Glimepiridum Tablets 1 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

5412 Glipid Glimepiridum Tablets 1 mg , 2 mg ,<br />

3mg , 4mg<br />

5413 Glipir Pioglitazonum Graver tablets 15 mg ; 30 mg<br />

; 45 mg<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

2/12/06<br />

31/07/05<br />

31/07/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

GENEXO Sp.z.o.o Warszawa 31/12/08<br />

Adamed Sp. z o.o. 31/12/08<br />

5414 Glipizide Glipizidum Tablets 5 mg Generics (UK) Limited 23/03/05<br />

5415 Glipizide BP Glipizidum Tablets 5 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

31/12/08<br />

5416 Glivec Imatinib Capsuels, hard 100 mg Novartis Pharma AG 25/10/06<br />

5417 Glivec Imatinib Capsuels, hard 50 mg Novartis Pharma AG 25/10/06<br />

5418 Glizipan Gliclazidum Modified release<br />

tablets<br />

5419 Glolfo Immunoglobulinum<br />

humanum normale ad<br />

usum intravenosum<br />

Solution for<br />

intravenous injection<br />

30 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

60 mg/ml Laboratorium Frakcjonowania<br />

Osocza, Mielec<br />

31/12/08<br />

31/12/08<br />

5420 Glonoin-Homaccord Amp. Heel GmbH 31/12/08<br />

5421 Glonoin-Homaccord N Drops Heel GmbH 31/12/08<br />

5422 Gloryfen Cefotaximum Powder for solution<br />

for intramuscular and<br />

intravenous injections<br />

1 g Help S.A. Pharmaceuticals<br />

Attica<br />

31/12/08


EN<br />

994 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5423 GlucaGen Glucagonum Powder and solvent<br />

for solution for<br />

injection<br />

5424 GlucaGen 1 mg HypoKit Glucagonum Powder and solvent<br />

for solution for<br />

injection<br />

5425 Glucalene Wapnia<br />

glukonianMagnezu<br />

glukonian-<br />

Fosforylkolamina-<br />

Cyjanokobalamina<br />

5426 Glucalvet Wapniowy chlorek,<br />

Magnezowy chlorek,<br />

Glukoza, Wersenian<br />

dwusodowy, Z˙elazawy<br />

siarczan, Miedziowy<br />

siarczan, Manganawy<br />

siarczan, Kobaltawy<br />

chlorek,<br />

5427 Glucardiamid Glucosum +<br />

Nicethamidum<br />

Solution for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Buccal tablets 1500mg +<br />

125mg<br />

1 mg Novo Nordisk A/S 18/10/06<br />

1 mg Novo Nordisk A/S 18/12/06<br />

Vetem S.p.A. 5/01/06<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

5428 Glucerna Preparat odz˙ywczy Liquid Ross Products Division-<br />

Abbott Laboratories<br />

31/12/08<br />

31/12/05<br />

30/04/04<br />

5429 Glucobay 50 Acarbosum Tablets 50 mg Bayer AG 31/07/04<br />

5430 Glucobay 100 Acarbosum Tablets 100 mg Bayer AG 31/07/04<br />

5431 Glucodiab Glibornuridum Tablets 25 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5432 Glucofen Preparat złoz˙ony Oral solution Laboratorium Galenowe<br />

‘LEFARM’ Sp. z o.o.<br />

31/12/08<br />

31/12/08<br />

5433 Glucophage 1000 Metforminum Film-coated tablets 1000 mg Lipha S.A. 31/12/08<br />

5434 Glucophage 500 Metforminum Film-coated tablets 500mg Lipha Sante 6/06/07<br />

5435 Glucophage 850 Metformini<br />

hydrochloridum<br />

Film-coated tablets 850 mg Lipha Sante 30/09/05<br />

5436 Glucosamin — Mip Glucosaminum Film-coated tablets 500 mg MIP Pharma Polska Sp. z o.o. 31/12/08<br />

5437 Glucosamina Glucosaminum Powder 1500 mg<br />

siarczanu<br />

glukozaminy<br />

POLFA KUTNO S.A. 31/12/08<br />

5438 Glucosamine Sulfate Glucosaminum Capsules 500 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5439 Glucose 40 Braun Glucosum Solution for<br />

intravenous infusion<br />

5440 Glucose 50 Braun Glucosum Solution for<br />

intravenous infusion<br />

5441 Glucose 70 Braun Glucosum Solution for<br />

intravenous infusion<br />

5442 Glucosum 5 % Glucosum Solution for<br />

intravenous infusion<br />

5443 Glucosum 5 % et Natrium<br />

chloratum 0,9 % (1:1)<br />

5444 Glucosum 5 % et Natrium<br />

chloratum 0,9 % (2:1)<br />

Glucosum + Natrii<br />

chloridum<br />

Glucosum + Natrii<br />

chloridum<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

31/12/08<br />

40 mg/ml B. Braun Melsungen AG 31/07/04<br />

50 mg/ml B. Braun Melsungen AG 31/07/04<br />

70 mg/ml B. Braun Melsungen AG 31/07/04<br />

50 mg/ml Fresenius Kabi Polska Sp. z<br />

o.o.<br />

(25mg +<br />

4,5mg)/ml<br />

(33,3mg +<br />

3mg)/ml<br />

Fresenius Kabi Polska Sp. z<br />

o.o.<br />

Fresenius Kabi Polska Sp. z<br />

o.o.<br />

31/12/08<br />

31/01/06<br />

31/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 995<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5445 Glucosum 5 % inj. Glucosum Solution for<br />

intravenous infusion<br />

50 mg/ml Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

5448 Glucosum 10 % Glucosum Solution for injection 100 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5446 Glucosum 10 % Glucosum Solution for<br />

intravenous infusion<br />

5447 Glucosum 10 % Glucosum Solution for<br />

intravenous infusion<br />

5449 Glucosum 10 % Glucosum Solution for veterinary<br />

use<br />

5450 Glucosum 10 % Inj. Glucosum Solution for veterinary<br />

use<br />

5451 Glucosum 20 % Glucosum Solution for<br />

intravenous infusion<br />

5452 Glucosum 20 % Glucosum Solution for<br />

intravenous infusion<br />

5453 Glucosum 20 % Glucosum Solution for<br />

intravenous injection<br />

5454 Glucosum 20 % Glucosum Solution for veterinary<br />

use<br />

5455 Glucosum 20 % INJ. Glucosum Solution for veterinary<br />

use<br />

5456 Glucosum 40 % Glucosum Solution for<br />

intravenous infusion<br />

5457 Glucosum 40 % Glucosum Solution for<br />

intravenous injection<br />

5458 Glucosum 5 % Glucosum Solution for veterinary<br />

use<br />

5459 Glucosum 5 % et Natrium<br />

Chloratum 0,9 % 1:1 inj.<br />

5460 Glucosum 5 % et Natrium<br />

Chloratum 0,9 % 2:1 inj.<br />

Glucosum + Natrii<br />

chloridum<br />

Glucosum + Natrii<br />

chloridum<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

5461 Glucosum 5 % INJ. Glucosum Solution for veterinary<br />

use<br />

5462 Glucosum 50 % Glucosum Solution for<br />

intravenous infusion<br />

5463 Glucosum 66 % Glucosum Solution for<br />

intravenous injection<br />

5464 Glucovance Metforminum +<br />

Glibenclamidum<br />

5465 Glucovance Metforminum +<br />

Glibenclamidum<br />

Film-coated tablets 500 mg +<br />

2,5 mg<br />

Film-coated tablets 500 mg +<br />

5mg<br />

5466 Gluctam Gliclazidum Prolonged release<br />

tablets<br />

5467 Gluformin Metformini<br />

hydrochloridum<br />

100 mg/ml Fresenius Kabi Polska Sp. z<br />

o.o.<br />

100 mg/ml Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Lubelskie Zakłady<br />

Farmaceutyczne ‘Polfa’ Spółka<br />

Akcyjna<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

19/12/06<br />

Fresenius Kabi Polska 31/12/08<br />

200 mg/ml Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

200 mg/ml Fresenius Kabi Polska Sp. z<br />

o.o.<br />

200 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Lubelskie Zakłady<br />

Farmaceutyczne ‘Polfa’ Spółka<br />

Akcyjna<br />

31/03/05<br />

31/01/06<br />

31/01/06<br />

19/12/06<br />

Fresenius Kabi Polska 31/12/08<br />

400 mg/ml Fresenius Kabi Polska Sp. z<br />

o.o.<br />

400 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Lubelskie Zakłady<br />

Farmaceutyczne ‘Polfa’ Spółka<br />

Akcyjna<br />

31/01/06<br />

31/01/06<br />

19/12/06<br />

Fresenius Kabi Polska 31/12/08<br />

Fresenius Kabi Polska 31/12/08<br />

Fresenius Kabi Polska 31/12/08<br />

500 mg/ml Fresenius Kabi Polska Sp. z<br />

o.o.<br />

660 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/01/06<br />

31/01/06<br />

Lipha S.A. 31/12/08<br />

Lipha S.A. 31/12/08<br />

80 mg Egis Pharmaceuticals Ltd. 16/05/07<br />

Film-coated tablets 850 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

23/11/05


EN<br />

996 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5468 Glukof Acidum ascorbicum<br />

(vit C) + Coffeinum +<br />

Glucosum<br />

Buccal tablet 100mg +<br />

200mg +<br />

880mg<br />

Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

5469 Glukoza Glucosum Tablets 1.9 g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

5470 Glukoza Glucosum Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

5471 Glukoza Glucosum Cefarm Gdańsk 31/01/06<br />

5472 Glukoza Glucosum Cefarm Wrocław 31/01/06<br />

5473 Glukoza Glucosum Felix Pharma, Lublin 31/01/06<br />

5474 Glukoza Glucosum Galena, Wrocław 31/01/06<br />

5475 Glukoza Glucosum Galenus, Warszawa 31/01/06<br />

5476 Glukoza Glucosum Hasco-Lek, Wrocław 31/01/06<br />

5477 Glukoza Glucosum Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

31/01/06<br />

5478 Glukoza Glucosum Lefarm, Bydgoszcz 31/01/06<br />

5479 Glukoza Glucosum Maga-Herba s.c., Legionowo 31/01/06<br />

5480 Glukoza Glucosum Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

31/01/06<br />

5481 Glukoza Glucosum Pliva Kraków 31/01/06<br />

5482 Glukoza Glucosum PPF GEMI, Karczew 31/01/06<br />

5483 Glukoza Glucosum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/01/06<br />

5484 Glukoza Glucosum Prolab, Paterek k/Nakła 31/01/06<br />

5485 Glukoza Glucosum PZF ‘Cefarm-Lublin’ S.A. 31/01/06<br />

5486 Glukoza Glucosum Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

31/01/06<br />

5487 Glukoza 10 Braun Glucosum Solution for infusion 100 mg/ml B. Braun Melsungen AG 24/04/06<br />

5488 Glukoza 20 Braun Glucosum Solution for infusion 200 mg/ml B. Braun Melsungen AG 14/03/07<br />

5489 Glukoza 5 Braun Glucosum Solution for infusion 50 mg/ml B. Braun Melsungen AG 26/04/06<br />

5490 Glurenorm Gliquidonum Tablets 30 mg Boehringer Ingelheim<br />

International GmbH<br />

5491 Glutarsin E Acidum glutamicum +<br />

Arginini hydrochloridum<br />

Solution for<br />

intravenous infusion<br />

(31,61mg +<br />

22,06mg)/ml<br />

Berlin-Chemie AG (Menarini<br />

Group)<br />

30/06/04<br />

31/07/04<br />

5492 Glycine 1,5 % Glycinum Solution for irrigation 15 mg/ml Baxter S.p.A. 27/04/06<br />

5493 Glycine max semen extractum<br />

siccum<br />

Glycine max semen<br />

extractum siccum<br />

5494 Glycophos Natrii glycerophosphas Concentrate for<br />

solution for infusion<br />

Film-coated tablets Specjalistyczne<br />

Przedsie˛biorstwo Rolno-<br />

Przetwórcze ‘GAL’ s.c.<br />

31/12/08<br />

216 mg/ml Fresenius Kabi AB 30/09/07<br />

5495 Glyoxal compositum Amp. Heel GmbH 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 997<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5496 Gnaphalium Pentarkan Drops DHU-Arzneimittel GmbH &<br />

Co.KG<br />

5497 Goats Butter Ointment- Mas´ć z<br />

koziego masła<br />

5498 Gocillin Benzylpenicillinum<br />

procainicum<br />

4/07/06<br />

Preparat złoz˙ony Ointment Alpine Herbs Produkte AG 30/04/04<br />

Suspension for veterinary<br />

use<br />

5499 Gonal F Follitropinum alfa Powder and solvent<br />

for solution for<br />

injection<br />

5500 Gonal F Follitropinum alfa Powder and solvent<br />

for solution for<br />

injection<br />

5501 Gonal F 75 IU Follitropininum alfa Lyophilisate and<br />

solvent for solution<br />

for subcutaneous<br />

injection<br />

5502 Gonasyl Gonadorelinum Solution for veterinary<br />

use<br />

Biowet Gorzów 31/12/08<br />

30 µg/0,75 ml Serono Europe Limited 31/12/08<br />

70 µg/1,75 ml Serono Europe Limited 31/12/08<br />

75 j.m. Industria Farmaceutica<br />

Serono Sp. A.<br />

31/12/04<br />

Laboratorios Syva 31/12/08<br />

5503 Gopten 0,5 Trandolaprilum Capsules 0.5 mg Abbott GmbH & Co KG 30/06/05<br />

5504 Gopten 2,0 Trandolaprilum Capsules 2 mg Abbott GmbH & Co KG 30/06/05<br />

5505 Gopten® 1,0 Trandolaprilum Capsules 1 mg Abbott GmbH & Co. KG 31/12/08<br />

5506 Gordox Aprotininum Solution for<br />

intravenous infusion<br />

5507 Gothaplast capsicum Nonivamidum Dressing with active<br />

substance<br />

5508 Gracial Desogestrelum,<br />

Ethinyloestradiolum<br />

500 000 KIU/<br />

50 ml<br />

(10 000 KIU/<br />

ml)<br />

13 mcg/cm 2<br />

kapsaicyny<br />

Chemical Works of Gedeon<br />

Richter Ltd.<br />

Gothaplast<br />

Verbandpflasterfabrik GmbH<br />

31/12/08<br />

31/12/08<br />

Tablets Organon 31/12/08<br />

5509 Gramurin Acidum oxolinicum Tablets 250 mg Chinoin Pharmaceutical and<br />

Chemical Works Co. Ltd.<br />

30/06/04<br />

5510 Grandaxin Tofisopamum Tablets 50 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

5511 Granocyte 34 Lenograstimum Lyophilisate for<br />

subcutaneous<br />

injection and<br />

intravenous infusion<br />

5512 Granudoxy Doxycyclinum<br />

monohydratum<br />

5513 Graphites-Dagomed 7 zmiany<br />

skórne<br />

33.6 mIU Chugai-Aventis 31/12/07<br />

Film-coated tablets 100 mg Pierre Fabre Dermatologie 31/12/08<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

5514 Graphites-Homaccord Amp. Heel GmbH 31/12/07<br />

5515 Graphites-Homaccord Drops Heel GmbH 31/12/07<br />

5516 Gravibinon Estradiolum +<br />

Hydroxyprogesteroni<br />

caproas<br />

5517 Gravistat Ethinylestradiolum +<br />

Levonorgestrelum<br />

5518 Gravistat 125 Ethinylestradiolum +<br />

Levonorgestrelum<br />

Solution for injection Schering AG 27/09/06<br />

Film-coated tablets Jenapharm GmbH & Co. 31/07/04<br />

Coated tablets Schering AG 30/06/05


EN<br />

998 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5519 Gricin Griseofulvinum Tablets 125 mg AWD.pharma GmbH & Co.<br />

KG<br />

31/07/04<br />

5520 Grinazole Metronidazolum Paste 100 mg/g Septodont 24/07/06<br />

5521 Grindella complexe nr 58 Drops Lehning Laboratoires 24/01/07<br />

5522 Grindemel N Preparat ziołowy Syrup Nova s.c. 30/10/05<br />

5523 Grindesol Grindeliae tinctura Oral solution Phytopharm Kle˛ka S.A. 31/12/08<br />

5524 Gripar C Acidum acetylsalicylicum,<br />

Paracetamolum, Acidum<br />

ascorbicum<br />

5526 Gripex Dextromethorphanum +<br />

Paracetamolum +<br />

Pseudoephedrinum<br />

5525 Gripex Dextromethorphanum +<br />

Paracetamolum +<br />

Pseudoephedrinum<br />

5527 Gripex Paracetamolum +<br />

Dextromethorphanum +<br />

Pseudoephedrinum<br />

5528 Gripex N Dextromethorphanum +<br />

Doxylamini succinatum<br />

+ Paracetamolum +<br />

Pseudoephedrinum<br />

5529 Gripex Noc Chlorpheniraminum +<br />

Dextromethorphanum +<br />

Paracetamolum +<br />

Pseudoephedrinum<br />

5530 Gripovac Szczepionka przeciw<br />

grypie koni<br />

5531 GRIPOZIN O Smaku<br />

Cytrynowym<br />

Effervescent tablets 300 mg +<br />

200 mg +<br />

300 mg<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/12/08<br />

Film-coated tablets US Pharmacia Sp. z o.o. 30/04/06<br />

Syrup US Pharmacia International<br />

Inc.<br />

12/10/05<br />

Capsules, soft US Pharmacia 31/12/08<br />

Syrup US Pharmacia International<br />

Inc.<br />

Film-coated tablets US Pharmacia International<br />

Inc.<br />

Suspension for veterinary<br />

use<br />

Loratadinum Effervescent tablets 500 mg +<br />

30 mg +<br />

60 mg<br />

11/10/06<br />

20/06/07<br />

Biowet Puławy 17/08/04<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5532 Grippe comp. krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

31/12/08<br />

30/11/05<br />

5533 Gripp-Heel Amp. Heel GmbH 31/12/07<br />

5534 Gripp-Heel Sublingual tablets Heel GmbH 31/12/07<br />

5535 Grippokaps Paracetamolum +<br />

Pseudoephedrini<br />

hydrochloridum<br />

5536 Grippokaps Paracetamolum +<br />

Pseudoephedrinum<br />

5537 Grippostad Paracetamolum Powder for oral<br />

solution<br />

Capsules, soft 250 mg +<br />

30 mg<br />

Capsules, soft 250 mg<br />

paracetamolu;<br />

30 mg<br />

chlorowodorku<br />

pseudoefedryny<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/08<br />

31/12/08<br />

600 mg Stada Arzneimittel AG 30/04/05<br />

5538 Grippostad C Preparat złoz˙ony Capsules Stada Arzneimittel AG 31/12/06<br />

5539 Gripsick Day Time Paracetamolum +<br />

Dextromethorphanum +<br />

Pseudoephedrinum<br />

Capsules, soft 250 mg +<br />

10 mg +<br />

30 mg<br />

UNIPHARM INC. 31/12/08<br />

5540 Gripsick Night Time Preparat złoz˙ony Capsules, soft UNIPHARM INC. 31/12/08<br />

5541 Griseofulvin M Griseofulvinum Tablets 125 mg Krka d.d., Novo mesto 31/12/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 999<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5542 Grisovet Granulat Griseofulvinum Granules for veterinary<br />

use<br />

5543 Grisovet Pasta Griseofulvinum Paste for veterinary<br />

use<br />

5544 Gro Spira 15 Metronidazolum +<br />

Spiramycinum<br />

5545 Gro Spira 5 Metronidazolum +<br />

Spiramycinum<br />

Tablets for veterinary<br />

use<br />

Tablets for veterinary<br />

use<br />

5546 Grobendazol Fenbendazol Granules for veterinary<br />

use<br />

5547 Grodalat Acebutololum +<br />

Nifedipinum<br />

Film-coated tablets 100mg +<br />

10mg<br />

Norbrook 31/12/08<br />

Norbrook Lab. 31/12/08<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

5548 Grofibrat Fenofibratum Capsules 100 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

5549 Grofibrat 200 Fenofibratum Capsules 200 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

5550 Grofibrat 67 Fenofibratum Capsules 67 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

5551 Grofilina Pentoxifyllinum Film-coated tablets 100 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

5552 Grofulwina Griseofulvinum Paste for veterinary<br />

use<br />

5553 Grolincos Lincomycinum +<br />

Spectinomycinum<br />

Premix for veterinary<br />

use<br />

5554 Gromeloksin Meloxicanum Tablets for veterinary<br />

use<br />

5555 Gromeloksin 1mg Meloxicanum Tablets for veterinary<br />

use<br />

5556 Gromeloksin 5mg Meloxicanum Tablets for veterinary<br />

use<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

5557 Groprazol Omeprazolum Capsules 20 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

5558 Groprinosin Inosinum pranobexum Tablets 500mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

5559 Groprofen Wedaprofen Paste for veterinary<br />

use<br />

5560 Groseptol Sulfamethoxazolum +<br />

Trimethoprimum<br />

5561 Groseptol Sulfamethoxazolum +<br />

Trimethoprimum<br />

5562 Grotis Miconazolum +<br />

Polimixinum B +<br />

Prednisolonum<br />

Tablets 100mg +<br />

20mg<br />

Tablets 400mg +<br />

80mg<br />

Suspension for veterinary<br />

use<br />

5563 Grovermina iwermektyna Paste for veterinary<br />

use<br />

5564 Grunamox Amoxicillinum Powder for<br />

suspension<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/09/05<br />

30/11/05<br />

31/05/05<br />

11/10/06<br />

30/09/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/08/05<br />

30/09/05<br />

31/12/08<br />

30/11/05<br />

30/11/05<br />

31/12/08<br />

31/12/08<br />

250 mg/5ml Grünenthal GmbH 30/06/07<br />

5565 Grunamox Tabs Amoxicillinum Tablets for suspension 1 g Grünenthal GmbH 30/06/07


EN<br />

1000 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5566 Grunamox Tabs Amoxicillinum Tablets for suspension 750 mg Grünenthal GmbH 30/06/07<br />

5567 Gryka fix Rutosidum Instant herbal tea Herbapol — Lublin S.A. 31/12/08<br />

5568 GRYPA — ROS<br />

(Inaktywowana szczepionka<br />

przeciw grypie) 1 ml<br />

Wirus grypy podtyp;A1X —<br />

113/680/91/H1N1A2 Resviv — 8<br />

94/762/H3N3Wirus grypy B (Chabvin 7/94)<br />

1 ml;<br />

szczepionka 2<br />

— dawkowa<br />

Państwowy Zakład Produkcji<br />

Preparatów Bakteryjnych,<br />

Sanktpetersb<br />

5569 Grypol Acidum acetylsalicylicum Tablets 350 mg CYNTFARM Sp. z o.o.,<br />

Pruszków<br />

31/12/08<br />

31/12/08<br />

5570 Grypolek Film-coated tablets Kato LABS Sp. z o.o. 30/04/06<br />

5571 Grypostop Dextromethorphanum +<br />

Paracetamolum +<br />

Pseudoephedrinum<br />

5572 Grypostop Mix o smaku<br />

cytrynowym<br />

Preparat złoz˙ony Powder for oral<br />

solution<br />

Film-coated tablets 15mg +<br />

325mg +<br />

30mg<br />

Perrigo Company 12/10/05<br />

Perrigo Company 12/10/05<br />

5573 Grypoxal Preparat złoz˙ony Tablets P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

5574 Guajafit Plantaginis lanceolatae<br />

folium+Verbasci<br />

flos+Kalii<br />

guaiacolosulfonas<br />

Syrup Herbapol — Lublin S.A. 31/12/08<br />

5575 Guajazyl Guaifenesinum Syrup 125 mg/5ml Espefa Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

5576 Guajazyl Guaifenesinum Syrup 20 mg/g VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

5577 Guajazyl Guaifenesinum Tablets 100 mg Espefa Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

5578 Guajazyl Mint Guaifenesinum +<br />

Dextromethrphanum<br />

Syrup 125 mg / 5 ml Chemiczno —<br />

Farmaceutyczna Spółdzielnia<br />

Pracy ESPEFA<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

31/12/08<br />

5579 Guaralgan Tablets N.P. Pharma Sp. z o.o. 28/02/06<br />

5580 Guma arabska Farm-Impex s.j., Gliwice 4/10/07<br />

5581 Guma arabska Pharma Cosmetic, Kraków 4/10/07<br />

5582 Guma arabska Pharma Zentrale 4/10/07<br />

5583 Guma arabska PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

5584 Gumbokal IM Szczepionka przeciw<br />

chorobie Gumboro dla<br />

kurcza˛t<br />

5585 Gumboral CT Szczepionka przeciw<br />

chorobie Gumboro dla<br />

kur<br />

5586 Gumboriffa Szczepionka przeciw<br />

chorobie Gumboro dla<br />

kur<br />

5587 Gumboro Vaccine MB. Szczepionka dla kur<br />

przeciw chorobie<br />

Gumboro<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

4/10/07<br />

Pliva 20/04/05<br />

Merial 17/08/04<br />

Merial 14/06/04<br />

ABIC 27/09/05<br />

5588 Gutron Midodrinum Drops 10 mg/ml Nycomed A GmbH 31/12/08<br />

5589 Gutron Midodrinum Solution for injection 2.5 mg/ml Nycomed Austria GmbH 31/07/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1001<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5590 Gutron Midodrinum Tablets 2.5 mg Nycomed Austria GmbH 31/07/04<br />

5591 Gutron Midodrinum Tablets 5 mg Nycomed A GmbH 31/12/08<br />

5592 Guttae cardiacae Liquid CYNTFARM Sp. z o.o.,<br />

Pruszków<br />

5593 Guttae stomachicae Drops Prolab s.c. — Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Produkcyjno-Analityczno-<br />

Handlowe s.c. Paterek<br />

5594 Guttalax Natrii picosulfas Capsules 2,5 mg Boehringer Ingelheim<br />

International GmbH<br />

5595 Guttalax Natrii picosulfas Drops Boehringer Ingelheim<br />

International GmbH<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

5596 Gutterin Drops Sp. NOVA, Swarze˛dz 31/12/08<br />

5597 Gwajafen Guaifenesinum Syrup 125 mg/5 ml Aflopa Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

31/12/08<br />

5598 Gwajakolosulfonian potasowy Pharma Cosmetic, Kraków 31/12/08<br />

5599 Gynacoheel N Drops Heel GmbH 31/12/07<br />

5600 Gynalgin Chlorquinaldolum +<br />

Metronidazolum<br />

5601 Gynipral Hexoprenalinum Concentrate for<br />

solution for infusion<br />

Vaginal tablets ICN Polfa Rzeszów S.A. 31/12/05<br />

25 µg/5 ml Nycomed A GmbH 31/12/08<br />

5602 Gynipral Hexoprenalinum Solution for injection 10 µg/2 ml Nycomed A GmbH 31/12/08<br />

5603 Gynipral Hexoprenalinum Tablets 0,5 mg Nycomed A GmbH 31/12/08<br />

5604 Gynobiotic neomycyna,<br />

oksytetracyklina<br />

Tablets for veterinary<br />

use<br />

Lek d.d. 31/12/08<br />

5605 Gyno-Daktarin Miconazoli nitras Pessary 100 mg Janssen Pharmaceutica N.V. 30/06/04<br />

5606 Gyno-Daktarin Miconazoli nitras Vaginal cream 20 mg/g ICN Polfa Rzeszów S.A. 31/12/05<br />

5607 Gynodian Depot Estradiolum +<br />

Prasteronum<br />

Solution for<br />

intramuscular<br />

injection<br />

Schering AG 11/08/05<br />

5608 Gyno-Femidazol Miconazoli nitras Vaginal tablets 100 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

5609 Gynoflor Lactobacillus acidophilus,<br />

Estriolum<br />

31/01/06<br />

Vaginal tablets Medinova Ltd. 31/12/08<br />

5610 Gyno-Pevaryl 50 Econazolum Pessary 50 mg Cilag AG 30/06/04<br />

5611 Gyno-Pevaryl 150 Econazolum Pessary 150 mg Cilag AG 30/06/04<br />

5612 Gyno-Pevaryl 150 Combipack Econazolum Pessary and vaginal<br />

cream<br />

150 mg +<br />

krem 10mg/g<br />

Cilag AG 30/06/04<br />

5613 Gyno-Pevaryl 50 Econazolum Vaginal cream 10 mg/g Cilag AG 30/06/04<br />

5614 Gyno-Pevaryl Depot Econazolum Pessary 150 mg Cilag AG 30/06/04<br />

5615 Gyno-Travogen Isoconazolum Vaginal tablets 0.3 g Schering AG 31/07/04<br />

5616 Gyno-Trosyd Tioconazolum Pessary 300 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

30/06/04<br />

5617 Gynoxin Fenticonazoli nitras Pessary 200 mg Recordati Sp.A 12/10/05


EN<br />

1002 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5618 Gynoxin Fenticonazoli nitras Pessary 600 mg Recordati Sp.A 12/10/05<br />

5619 Gynoxin Fenticonazoli nitras Vaginal cream 2 % Recordati Sp.A 12/10/05<br />

5620 Haemate P 1000 Coagulation factor VIII<br />

+ Von Willebrand factor<br />

5621 Haemate P 250 Coagulation factor VIII<br />

+ Von Willebrand factor<br />

5622 Haemate P 500 Coagulation factor VIII<br />

+ Von Willebrand factor<br />

5623 Haematoven Gel Aescinum + Heparinum<br />

+ Lecithinum<br />

Lyophilisate and solvent for solution for<br />

injection and intravascular infusion<br />

Lyophilisate and solvent for solution for<br />

injection and intravascular infusion<br />

Lyophilisate and solvent for solution for<br />

injection and intravascular infusion<br />

5624 Haemocomplettan P Fibrinogenum humanum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

5625 Haemocomplettan P Fibrinogenum humanum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

5626 Haemoctin SDH 250 Coagulation factor VIII Intravenous injection<br />

(lyophilisate)<br />

5627 Haemoctin SDH 500 Coagulation factor VIII Intravenous injection<br />

(lyophilisate)<br />

5628 Haemoctin SDH 1.000 Coagulation factor VIII Intravenous injection<br />

(lyophilisate)<br />

5629 HAES — steril 6 % Hydroxyethylamylum Solution for<br />

intravenous infusion<br />

5630 HAES — steril 10 % Hydroxyethylamylum Solution for<br />

intravenous infusion<br />

Centeon Pharma GmbH 31/01/05<br />

Centeon Pharma GmbH 31/01/05<br />

Centeon Pharma GmbH 31/01/05<br />

Gel for external use Rhone-Poulenc Rorer A.<br />

Natterman & Cie.GmbH<br />

30/04/04<br />

1 g Centeon Pharma GmbH 30/04/04<br />

2 g Centeon Pharma GmbH 30/04/04<br />

250 j.m. Biotest Pharma GmbH 31/12/07<br />

500 j.m. Biotest Pharma GmbH 31/12/07<br />

1000 j.m. Biotest Pharma GmbH 31/12/07<br />

60 mg/ml Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

100 mg/ml Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

31/07/04<br />

31/07/04<br />

5631 Hairkare Tablets Lifeplan Products Ltd. 30/04/04<br />

5632 Halicar Mas´ć DHU-Arzneimittel GmbH &<br />

Co.KG<br />

7/03/05<br />

5633 Halidor Bencyclanum Solution for injection 25 mg/ml Egis Pharmaceuticals Ltd. 30/06/04<br />

5634 Halidor Bencyclanum Tablets 100 mg Egis Pharmaceuticals Ltd. 30/06/04<br />

5635 Haloperidol Haloperidolum Oral drops, solution 2 mg/ml Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

5636 Haloperidol Haloperidolum Solution for injection 5 mg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

5637 Haloperidol Haloperidolum Tablets 1 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

5638 Haloperidol Haloperidolum Tablets 10 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

5639 Haloperidol Haloperidolum Tablets 5 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

5640 Haloperidol 0,2 % Haloperidolum Oral drops, solution 2 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/01/06<br />

31/05/06<br />

30/11/05<br />

31/12/07<br />

31/12/07<br />

12/09/07<br />

5641 Haloperidol Decanoat Haloperidolum Solution for injection 70,52mg/ml Gedeon Richter Ltd. 31/07/04<br />

5642 Halset Cetylpyridinium Buccal tablet 1.5 mg P.P.H.U. Biofarm Sp. z o.o. 30/04/05<br />

5643 Halset Strong Cetylpyridini chloridum Buccal tablets 2,5 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5644 Hamamelis-Heel S Ointment Heel GmbH 31/07/05<br />

5645 Hamamelis-Homaccord Amp. Heel GmbH 31/12/08<br />

5646 Hamamelis-Homaccord Drops Heel GmbH 31/12/08<br />

5647 Hämatopan 100 Ferrosi sulphas Film-coated tablets 272 mg,<br />

(100 mg Fe2+)<br />

5648 Hämatopan 50 Ferrosi sulphas Film-coated tablets 136 mg,<br />

(50 mg Fe2+)<br />

Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

31/12/08<br />

31/12/08<br />

5649 Hansaplast Corn Plaster Acidum salicylicum Pach 40 % Beiersdorf AG 31/12/08<br />

5650 Hapilux Fluoxetinum Capsules 20 mg Biochemie GmbH 31/12/08<br />

5651 Hared Rilmenidinum Tablets 1 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

5652 Harmonet Ethinylestradiolum +<br />

Gestodenum<br />

31/12/08<br />

Film-coated tablets Wyeth-Lederle Pharma GmbH 31/05/05<br />

5653 Harntee 400 TAD Pharmazeutical 31/12/08<br />

5654 Harpacur Harpagophyti radix<br />

extractum siccum,<br />

Urticae folium extractum<br />

siccum<br />

Capsules, hard 175 mg;<br />

87,5 mg<br />

Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

31/12/08<br />

5655 Harpadol Lab. Arkopharma 31/12/08<br />

5656 Harpagon Harpagophyti radix Film-coated tablets 150 mg Medana Pharma Terpol<br />

Group S.A.<br />

5657 Harpasil Harpagophytum<br />

extractum + Salicis<br />

extractum siccum +<br />

Urticae succus<br />

5658 Harpoon(poprzednia<br />

nazwa:harpago)<br />

5659 Hasceral Acidum salicylicum +<br />

Urea<br />

Drops Zakład Chemiczno-<br />

Farmaceutyczny ‘FARMAPOL’<br />

Sp. z o.o., Poznań<br />

14/12/05<br />

31/12/08<br />

Harpagophyti radix pulv. Capsules, hard 435 mg Agropharm S.A. 31/12/08<br />

Ointment (50mg +<br />

100mg)/g<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

5660 Hascobaza Podłoz˙e mas´ciowe Ointment base Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

5661 Hascoderm Acidum azelaicum Cream 200 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

5662 Hascofungin Ciclopiroxum Cream 1 g/100 g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

5663 Hascofungin Ciclopiroxum Liquid for external use 10 mg / 1ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

5664 Hascopar Paracetamolum Capsules, soft 250 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

5665 Hascosept Benzydamidum Buccal tablets 3 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

5666 Hascosept Benzydamini<br />

hydrochloridum<br />

Oromucosal solution 1.5 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

5667 Hascosept AD Benzydamidum Oromucosal gel 0,15 g / 100 g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/05/05<br />

31/12/08<br />

31/08/05<br />

5/07/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/03/06<br />

31/12/08


EN<br />

1004 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5668 Hascovir Aciclovirum Cream 50 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

5669 Hascovir Aciclovirum Tablets 200 mg ;<br />

400 mg<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

5670 Hasco-Z˙el Benzydamidum Gel for external use 5 g / 100 g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

5671 Havrix 720 Junior Hepatitis A, inactivated,<br />

whole virus<br />

5672 Havrix Adult Hepatitis A, inactivated,<br />

whole virus<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

720 j.ELISA./<br />

0,5 ml<br />

1440 j.ELISA./<br />

1ml<br />

SmithKline Beecham<br />

Biologicals<br />

SmithKline Beecham<br />

Biologicals<br />

22/02/06<br />

31/12/08<br />

31/12/08<br />

30/06/07<br />

6/02/06<br />

5673 Hay-Crom Acidum cromoglicicum Eye drops, solution 20 mg/ml Norton Healthcare Ltd. 30/04/05<br />

5674 H-B-Vax II Hepatitis B, purified<br />

antigen<br />

Suspension for<br />

intramuscular<br />

injection<br />

5675 H-B-Vax II Vaccinum hepatitidis B Suspension for<br />

intramuscular<br />

injection<br />

5676 H-B-Vax II Vaccinum hepatitidis B Suspension for<br />

intramuscular<br />

injection<br />

5677 HBVax PRO Suspension for<br />

injection<br />

5678 HBVaxPRO Suspension for<br />

injection<br />

5679 HBVaxPRO Suspension for<br />

injection<br />

40 mcg/ 1 ml MSD Idea Inc. 12/10/05<br />

10 mcg/1 ml Merck Sharp & Dohme Idea<br />

Inc.<br />

5 mcg/0,5 ml Merck Sharp & Dohme Idea<br />

Inc.<br />

29/04/04<br />

29/02/04<br />

5 mcg/0,5 ml MSD Idea Inc. 29/08/07<br />

10 mcg/1 ml MSD Idea Inc. 29/08/07<br />

40 mcg/1 ml MSD Idea Inc. 29/08/07<br />

5680 Hc 45 Hydrocortisonum Cream 10 mg/g Boots Healthcare<br />

International<br />

5681 Healing Shampoo Shampoo 10 mg/g Przedsie˛biorstwo Zagraniczne<br />

Catzy of Poland<br />

31/05/04<br />

31/12/05<br />

5682 Health Duet Preparat złoz˙ony Capsules + tablets Lysi Ltd. 31/12/08<br />

5683 Hedelicum Syrup N.P. Pharma Sp. z o.o. 30/04/05<br />

5684 Hedelix Hederae helicis extractum<br />

fluidum<br />

5685 Hedelix Hederae helicis extractum<br />

siccum<br />

5686 Hedelix s.a. Hederae helicis extractum<br />

spissum (1:1)<br />

Syrup 100 mg/5ml Krewel Meuselbach GmbH<br />

Eitorf<br />

Oral drops 940 mg/ml Krewel Meuselbach GmbH<br />

Eitorf<br />

21/06/05<br />

21/06/05<br />

Oral drops 100mg/ml Krewel Meuselbach GmbH 31/12/08<br />

5687 Hedera complexe nr 120 Drops Lehning Laboratoires 24/01/07<br />

5688 Hederasal Hederae helicis folium<br />

extractum siccum<br />

Syrup 26.6 mg/5 ml Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

5689 Hederasal d Syrup Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

5690 Hederoin Hederae helicis folium<br />

extractum siccum<br />

Tablets 15 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

5691 Heksalen Altretaminum Capsules 50 mg Teva Pharmaceutical<br />

Industries<br />

24/08/05<br />

31/12/08<br />

9/08/06<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1005<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5692 Helarium Hyperici herbae<br />

extractum sicc.<br />

5693 Helason Heparinum +<br />

Hyaluronidasum<br />

5694 Helical Hederae helicis extractum<br />

siccum<br />

Coated tablets 255-285 mg Bionorica Arzneimittel GmbH 31/12/08<br />

Ointment (100 j.m. +<br />

150 j.m.)/g<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Syrup 5mg/5ml Medana Pharma TERPOL<br />

Group S.A.<br />

30/11/05<br />

31/12/08<br />

5695 Helicid 10 Omeprazolum Capsules 10 mg Lečiva a.s. 26/04/06<br />

5696 Helicid 20 Omeprazolum Capsules 20 mg Lečiva a.s. 31/07/04<br />

5697 Helicid 40 Inf Omeprazolum Powder for solution<br />

for infusion<br />

40 mg Leciva a.s. 31/12/08<br />

5698 Helisec 10 Omeprazolum Capsules 10 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

5699 Helisec 20 Omeprazolum Capsules 20 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

5700 Helisec 40 Omeprazolum Capsules 40 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

5701 HELLEBORUS/ALUMEN<br />

comp., ampułki<br />

5702 HELLEBORUS/ALUMEN<br />

comp., granulki<br />

5704 Hemcort-HC Hydrocortisonum +<br />

Zinci sulfas<br />

5703 Hemcort-HC Hydrocortisonum +<br />

Zinci sulfas<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

Rectal ointment Polmex Sp. z o.o. 31/05/05<br />

Suppository Polmex Sp. z o.o. 31/05/05<br />

5705 Heminevrin Clomethiazolum Capsules 300 mg AstraZeneca AB 30/06/04<br />

5706 Hemo LFO-B Czynnik krzepnie˛cia IX<br />

ludzki<br />

Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

injection and<br />

intravenous infusion<br />

500 IU Laboratorium Frakcjonowania<br />

Osocza<br />

31/12/08<br />

5707 Hemocal, czopki Farmina Sp. z o.o., Kraków 21/09/06<br />

5708 Hemodermin Mas´ć Asa, Głubczyce 31/01/06<br />

5709 Hemofer Ferrosi chloridum Oral drops, solution 44 mg Fe++/ml Medana Pharma Terpol<br />

Group S.A.<br />

5710 Hemofer F prolongatum Acidum folicum +<br />

Ferrosi sulfas<br />

Coated tablets 0.105 g Fe++ GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

5711 Hemofer prolongatum Ferrosi sulfas Coated tablets 105 mg Fe++ GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

5712 Hemofil M Czynnik VIII<br />

antyhemofilowy (ludzki)<br />

Method M<br />

5713 Hemofil M Czynnik VIII<br />

antyhemofilowy (ludzki)<br />

Method M<br />

Coagulation factor VIII Intravenous injection<br />

(lyophilisate)<br />

Coagulation factor VIII<br />

(Czynnik VIII krzepnie˛cia<br />

oczyszczony za pomoca<br />

przeciwciał<br />

monoklonalnych)<br />

Lyophilisate for<br />

intravenous use<br />

30/01/05<br />

31/01/06<br />

30/01/05<br />

250 j.m. Taylor Pharmaceuticals 31/12/08<br />

1000 j.m. Baxter Healthcare<br />

Corporation Hyland Immuno<br />

31/12/08


EN<br />

1006 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5714 Hemofil M Czynnik VIII<br />

antyhemofilowy (ludzki)<br />

Method M<br />

5715 Hemofil M Czynnik VIII<br />

antyhemofilowy (ludzki)<br />

Method M<br />

Coagulation factor VIII<br />

(Czynnik VIII krzepnie˛cia<br />

oczyszczony za pomoca<br />

przeciwciał<br />

monoklonalnych)<br />

Coagulation factor VIII<br />

(Czynnik VIII krzepnie˛cia<br />

oczyszczony za pomoca<br />

przeciwciał<br />

monoklonalnych)<br />

5716 Hemohes 10 % Hydroxyethylamylum +<br />

Natrii chloridum<br />

5717 Hemohes 6 % Hydroxyethylamylum +<br />

Natrii chloridum<br />

5718 Hemore Graphtophilli folium<br />

extractum<br />

Lyophilisate for<br />

intravenous use<br />

Lyophilisate for<br />

intravenous use<br />

Solution for infusion (100mg +<br />

9mg)/ml<br />

Solution for infusion (60mg + 9mg)/<br />

ml<br />

500 j.m. Baxter Healthcare<br />

Corporation Hyland Immuno<br />

250 j.m. Baxter Healthcare<br />

Corporation Hyland Immuno<br />

31/12/08<br />

31/12/08<br />

B. Braun Melsungen AG 15/03/06<br />

B. Braun Melsungen AG 15/03/06<br />

Capsules, hard 200 mg PT. Dexa Medica 31/12/08<br />

5719 Hemorectal Preparat złoz˙ony Suppository GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

5720 Hemorigen Erigeronis canadense<br />

intractum<br />

31/01/06<br />

Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

5721 Hemorigen Tablets 50 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

5722 Hemorik Preparat złoz˙ony Capsules, hard Bright Future Pharmaceuticals<br />

Factory, Hongkong<br />

5723 Hemoroflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

5724 Hemoroidal Hamamelis cortex<br />

extractum spissum,<br />

Lidocainum<br />

Ointment Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

5725 Hemorol Suppository Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

5726 Hemostin Cutaneous spray Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

5727 Hepacholin Preparat złoz˙ony Film-coated tablets ELANDA Zakład Prod.<br />

S´ rodków<br />

Farmaceutycznych,B. Kazub,<br />

A. Orłowski, Spółka jawna,<br />

Rozprza<br />

30/10/05<br />

31/12/08<br />

30/04/05<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

5728 Hepacom Timonacicum Tablets 100 mg Sanofi-Synthelabo Sp. z o.o. 31/12/05<br />

5729 Hepacynar Cynarae folium<br />

extractum siccum<br />

Capsules 400 mg Europlant Phytopharm , Sp. z<br />

o.o., Nowe Miasto nad Warta˛<br />

31/12/08<br />

5731 Hepa-Merz Ornithinum Solution for injection 100 mg/ml Merz & Co. GmbH 31/01/05<br />

5730 Hepa-Merz Ornithinum Solution for<br />

intravenous infusion<br />

500 mg/ml Merz & Co. GmbH 31/01/05<br />

5732 Hepa-Merz Film-coated tablets Merz & Co. GmbH 31/01/05<br />

5733 Hepar compositum N Amp. Heel GmbH 31/12/07<br />

5734 Hepar Sulfuris comp. Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

5735 Hepar/Stannum I Amp. 1 ml WALA-Heilmittel GmbH 24/05/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1007<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5736 Heparegen Timonacicum Tablets 0.1 g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

5737 Heparen Heparinum Gel 100.000 j.m. /<br />

100 g<br />

5738 Heparin Biochemie Heparinum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

5739 Heparin Forte Heparinum Gel 100.000 j.m. /<br />

100 g<br />

5740 Heparin Natrium-Braun<br />

25.000<br />

Heparinum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

or for intravenous<br />

infusion<br />

Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych ‘EMO’<br />

30/10/05<br />

31/12/08<br />

5000 j.m./ml Biochemie GmbH — Kundl 30/11/04<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/08<br />

5000 j.m./ml B. Braun Melsungen AG 30/04/05<br />

5741 Heparin-Hasco Heparinum Gel 250 j.m./g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

5742 Heparinum Heparinum Cream 30.000 j.m. /<br />

100g<br />

15/11/06<br />

Aflofarm 31/12/08<br />

5743 Heparinum Heparinum Cream 300 j.m./g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

5744 Heparinum Heparinum Solution for<br />

intravenous injection<br />

5745 Heparinum Heparinum Solution for<br />

subcutanous injection<br />

5746 Heparinum Heparinum Solution for<br />

subcutanous injection<br />

5000 j.m./ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

25000 j.m./<br />

1ml<br />

5000 j.m./<br />

0,2 ml<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

5747 Heparizen Heparinum Gel 1000 j.m./g ZIAJA Ltd. Zakład<br />

Produkcyjny Gdańsk<br />

31/12/05<br />

31/05/06<br />

31/05/06<br />

31/12/05<br />

31/12/08<br />

5748 Heparyl Heparinum Ointment 300 j.m./g ratiopharm GmbH 11/10/06<br />

5749 Hepatect Hepatitis B<br />

immunoglobulin<br />

5750 Hepatect Cp Immunoglobulinum<br />

hepatitis B humanum<br />

Solution for<br />

intravenous infusion<br />

5751 Hepatil Ornithinum Granules for oral<br />

solution<br />

5752 Hepatil Ornithinum Solution for<br />

intravenous infusion<br />

50 j.m./ml Biotest Pharma GmbH 30/04/04<br />

Solution for infusion 50 j.m./ml Biotest Pharma GmbH 31/12/08<br />

3 g Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

100 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5753 Hepatil Ornithinum Tablets 150 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5754 Hepatil — Vit Tablets Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5755 Hepatina Herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

5756 Hepatina Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

5757 HEPATITIS B<br />

IMUNOGLOBULINE 300 J.M.<br />

Immunoblobulinum<br />

humanum hepatitiois B<br />

Solution for<br />

intramuscular<br />

injection<br />

300 j.m. Sanquin, CLB Products<br />

Division<br />

30/11/05<br />

18/01/06<br />

31/05/04<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

31/12/08


EN<br />

1008 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5758 HEPATITIS B<br />

IMUNOGLOBULINE 500 J.M.<br />

Immunoblobulinum<br />

humanum hepatitiois B<br />

Solution for<br />

intramuscular<br />

injection<br />

500 j.m. Sanquin, CLB Products<br />

Division<br />

5759 Hepatobonisan Instant herbal tea Laboratorium Medycyny<br />

Naturalnej BONIMED, Z˙ywiec<br />

31/12/08<br />

31/12/08<br />

5760 Hepatodoron tabletki WELEDA 24/08/05<br />

5761 Hepato-Drainol krople Drops Laboratoires BOIRON 31/12/07<br />

5762 Hepatofalk Planta Capsuels, hard Dr Falk Pharma GmbH 24/08/05<br />

5763 Hepaurik Preparat złoz˙ony Capsules, hard PT. IKONG Pharmaceutical<br />

Industry CO<br />

5764 Hepavax-Gene Vaccinum hepatitidis B<br />

(ADNr)<br />

5765 Hepavax-Gene Vaccinum hepatitidis B<br />

(ADNr)<br />

Suspension for<br />

intramuscular<br />

injection<br />

Suspension for<br />

intramuscular<br />

injection<br />

10 mcg/0,5 ml GreenCross Vaccine<br />

Corporation<br />

20 mcg/ 1 ml GreenCross Vaccine<br />

Corporation<br />

31/12/08<br />

25/01/06<br />

25/01/06<br />

5766 Hepeel Amp. Heel GmbH 31/12/07<br />

5767 Hepeel Sublingual tablets Heel GmbH 31/12/07<br />

5768 Hepochron 3 g Ornithini aspartas Effervescent powder 3 g MIP Pharma Sp. z o.o. 31/12/08<br />

5769 Hepochron 5 g Ornithini aspartas Effervescent powder 5 g MIP Pharma Sp. z o.o. 31/12/08<br />

5770 Herbabiloba Ginkgo bilobae folium<br />

extractum siccum<br />

5771 Herbadont B Bergeniae extratum<br />

liquidum + Menthae<br />

piperitae oleum<br />

Capsuels, hard 40 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

Gingival paste Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

5772 Herbamal Herbal tea HO VAN HOR SDN. BHD,<br />

Malezja<br />

5773 Herbamelvit Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

5774 Herbapect Thymi extractum fluidum<br />

+ Primulae tinctura +<br />

sulfogaiacolum<br />

Syrup ( 498 mg +<br />

348mg +<br />

87mg)/ 5ml<br />

Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

29/06/05<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

1/04/06<br />

5775 Herbapect Dla Dzieci Syrup Aflofarm 31/12/08<br />

5776 Herbarelax Tablets Ameri Vita LLC USA 31/12/08<br />

5777 Herbaton Preparat ziołowy Drops Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

5778 Herbi chol Preparat złoz˙ony Capsules, hard Laboratorium Galenowe<br />

‘LEFARM’ Sp. z o.o.<br />

5779 Herbogastrin Oral solution Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

5780 Herbolen Preparat ziołowy Ointment Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

5781 Herbolen D Preparat ziołowy Ointment Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

5782 Herceptin Trastuzumabum Powder for<br />

concentrate for<br />

solution for infusion<br />

150 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

2/10/06<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

31/01/05<br />

14/12/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1009<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5783 Herpesin Aciclovirum Lyophilisate for<br />

solution for injection<br />

250 mg PLIVA — LACHEMA a.s. 31/05/04<br />

5784 Herpex Aciclovirum Cream 50 mg/g HEXAL AG 30/09/07<br />

5785 Hesmin Diosminum +<br />

Hesperidinum<br />

Film-coated tablets 450 mg +<br />

50 mg<br />

Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

5786 Hesperynin Hesperidinum Tablets 50 mg Kenay A.G., Cze˛stochowa 31/12/08<br />

5787 Heviran Aciclovirum Cream 5 % (50 mg/g) Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

5789 Heviran Aciclovirum Film-coated tablets 200 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

5790 Heviran Aciclovirum Film-coated tablets 400 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

5791 Heviran Aciclovirum Film-coated tablets 800 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

5788 Heviran Aciclovirum Tablets 200 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

5792 Hevizos Epervudinum Ointment 8 mg/g Biogal Pharmaceutical Works<br />

Ltd.<br />

5793 Hexadog Szczepionka dla psów<br />

przeciw nosówce,<br />

zakaz˙eniom<br />

adenowirusowym i<br />

parwowirusowym,<br />

leptospirozie i<br />

ws´ciekliz´nie<br />

Lyophilisate + solvent for veterinary<br />

use<br />

31/12/08<br />

12/10/05<br />

12/10/05<br />

12/10/05<br />

31/01/06<br />

30/11/04<br />

Merial 7/05/04<br />

5794 Hexamandin Methenaminum Tablets 250 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

31/12/05<br />

5795 Hexaspral Biclotymolum Oromucosal spray 25 mg/1 g Laboratoires Doms — Adrian 31/12/08<br />

5796 Hexavac Szczepionka Suspension for<br />

intramuscular<br />

injection<br />

1 dawka<br />

0,5 ml<br />

Aventis Pasteur MSD SNC 29/08/07<br />

5797 HEXAVIT — Multivitamin Preparat witaminowy KYIV VITAMIN FACTORY Co 31/12/08<br />

5798 Hexiderm Heksetydyna,<br />

Prednizolon,<br />

Benzokaina<br />

Solution for veterinary<br />

use<br />

Fort Dodge Animal Health 31/12/08<br />

5800 Hialuronian Acidum hyaluronicum Solution for injection 20 mg/ 2ml Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5799 Hialuronian Acidum hyaluronicum Vial 20 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5801 Hiberix Powder and solvent<br />

for suspension for<br />

injection<br />

5802 HibTiter Hemophilus influenzae<br />

B, purified antigen<br />

conjugated<br />

Solution for<br />

intramuscular<br />

injection<br />

10 mcg SmithKline Beecham<br />

Biologicals<br />

31/12/08<br />

31/12/08<br />

31/03/07<br />

Wyeth-Lederle Pharma GmbH 22/03/06<br />

5803 Hiconcil Amoxicillinum Capsules 250 mg Krka d.d., Novo mesto 30/04/04<br />

5804 Hiconcil Amoxicillinum Capsules 500 mg Krka d.d., Novo mesto 30/04/04<br />

5805 Hiconcil Amoxicillinum Powder for oral<br />

suspension<br />

0.1 g/ml Krka d.d., Novo mesto 30/04/04


EN<br />

1010 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5806 Hiconcil Amoxicillinum Powder for oral<br />

suspension<br />

5807 Hiconcil Amoxicillinum Substance for oral<br />

suspension<br />

125 mg/5ml Krka d.d., Novo mesto 30/04/04<br />

250 mg/5ml Krka d.d., Novo mesto 30/04/04<br />

5808 Hioscyny bromowodorek BUFA b.v. Pharmaceutical<br />

Products<br />

31/05/05<br />

5809 Hioscyny bromowodorek Pharma Cosmetic, Kraków 31/05/05<br />

5810 Hioscyny bromowodorek Pharma Zentrale 31/05/05<br />

5811 Hipertoniczny roztwór 7,2 %<br />

NaCl<br />

Natrii chloridum Solution for veterinary<br />

use<br />

Biowet Puławy 31/12/08<br />

5812 Hipokrates Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

5813 Hipokrates fix Mieszanka ziołowa Instant herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

5814 Hiponervex Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

5815 Hiposem Hippocastani semen<br />

pulv.<br />

Tablets 340 mg Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

31/12/08<br />

5816 Hipotravex Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

5817 Hipradoxi-S Doxycyclinum Solution for veterinary<br />

use<br />

5818 Hipragumbora-CH/80 z˙ywa liofilizowana<br />

szczepionka dla kur,<br />

przeciwko chorbie<br />

gumboro<br />

5819 Hipratifus — AV2 szczepionka dla drobiu<br />

przeciwko<br />

salmonelozie<br />

5820 Hipraviar BPL2 szczepionka dla kur<br />

przeciwko rzekomemu<br />

pomorowi drobiu<br />

5821 Hipraviar-Clon Z˙ywa szczepionka dla<br />

kur przeciwko<br />

rzekomemu pomorowi<br />

drobiu<br />

5822 Hipraviar-Clon/H-120 Z˙ywa szczepionka dla<br />

kur przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli i rzekomemu ,<br />

pomorowi drobiu<br />

5823 Hipuran — 131 Ido<br />

wstrzykiwań<br />

Preparat<br />

radiodiagnostyczny<br />

Lyophilisate for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Hipra 31/12/08<br />

Hipra 31/12/08<br />

Hipra 31/12/08<br />

Hipra 31/12/08<br />

Laboratorios Hipra S.A. 24/06/07<br />

Laboratorios Hipra S.A. 24/06/07<br />

Solution for injection Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

30/01/05<br />

5824 HIRUDO comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

5825 HIRUDO comp. gran. WALA-Heilmittel GmbH 19/03/05<br />

5827 Hirudoid Heparynoidy, kombinacje Gel Sankyo Pharma GmbH —<br />

München<br />

5826 Hirudoid Heparynoidy, kombinacje Ointment Sankyo Pharma GmbH —<br />

München<br />

31/05/04<br />

31/05/04<br />

5829 Hismanal Astemizolum Oral suspension 1 mg/ml Janssen Pharmaceutica N.V. 30/06/04<br />

5830 Hismanal Astemizolum Oral suspension 1 mg/ml ICN Polfa Rzeszów S.A. 31/12/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1011<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5828 Hismanal Astemizolum Tablets 10 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

5832 Histac Ranitidinum Film-coated tablets 150 mg Ranbaxy Laboratories Ltd. 31/12/07<br />

5833 Histac Ranitidinum Film-coated tablets 300 mg Ranbaxy Laboratories Ltd. 31/12/07<br />

5834 Histac Ranitidinum Film-coated tablets 75 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

5831 Histac Ranitidinum Solution for<br />

intramuscular and<br />

intravenous injection<br />

25 mg/ml Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

5835 Histadermin Ointment Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

5836 Histaglobin Histaminum +<br />

Immunoglobulinum<br />

humanum<br />

5837 Histaglobin Triplex Histaminum +<br />

Immunoglobulinum<br />

humanum<br />

5838 Histaglobina Histaminum +<br />

Immunoglobulinum<br />

humanum<br />

Powder and solvent for solution for<br />

injection subcutaneous or intramuscular<br />

Powder and solvent for solution for<br />

injection subcutaneous or intramuscular<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

0,15mcg +<br />

12mg<br />

5/07/06<br />

5/07/06<br />

30/11/05<br />

Biobasal AG 17/01/07<br />

Biobasal AG 17/01/07<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

5839 Histar Fexofenadinum Film-coated tablets 120 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

5840 Histar Fexofenadinum Film-coated tablets 180 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/03/06<br />

31/12/08<br />

31/12/08<br />

5841 Histimerck 16 Betahistinum Tablets 16 mg Generics (UK) Limited 11/10/06<br />

5842 Histimerck 8 Betahistinum Tablets 8 mg Generics (UK) Limited 11/10/06<br />

5844 Histimet Levocabastinum Eye drops, solution 0.5 mg/ml Krka d.d., Novo mesto 31/03/06<br />

5843 Histimet Levocabastinum Nasal spray, solution 0.5 mg/ml Krka d.d., Novo mesto 31/03/06<br />

5845 Hivid Zalcitabinum Film-coated tablets 0.375 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

5846 Hivid Zalcitabinum Film-coated tablets 0.75 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

31/03/07<br />

31/03/07<br />

5847 Holetar Lovastatinum Tablets 20 mg KRKA d.d., Novo mesto 31/12/08<br />

5848 Holetar Lovastatinum Tablets 20 mg KRKA Polska Sp. z o.o. 31/12/08<br />

5849 Holoxan Ifosfamidum Lyophilisate for<br />

injection<br />

5850 Holoxan Ifosfamidum Powder for solution<br />

for injection<br />

5851 Holoxan Ifosfamidum Powder for solution<br />

for injection<br />

3 g Asta Medica AG 31/07/04<br />

1 g Asta Medica AG 31/07/04<br />

2 g Asta Medica AG 31/07/04<br />

5852 Homatropiny bromowodorek BUFA b.v. Pharmaceutical<br />

Products<br />

19/01/05<br />

5853 Homatropiny bromowodorek Pharma Zentrale 19/01/05<br />

5854 Homatropiny chlorowodorek Caesar & Loretz GmbH Caelo 31/12/08<br />

5855 Homatropiny chlorowodorek Pharma Cosmetic, Kraków 31/12/08<br />

5856 Homeodose 18 krople Dolisos Laboratoires 31/12/08


EN<br />

1012 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5857 Homeodose 20 krople Dolisos Laboratoires 31/12/08<br />

5858 Homeodose 24 krople Dolisos Laboratoires 31/12/08<br />

5859 Homeodose 3 krople Dolisos Laboratoires 31/12/08<br />

5860 Homeodose 30 Dolisos Laboratoires 30/10/05<br />

5861 Homeodose 4 krople Dolisos Laboratoires 31/12/08<br />

5862 Homeodose 8 Dolisos Laboratoires 30/10/05<br />

5863 Homeogene 46 Tablets Laboratoires BOIRON 31/12/07<br />

5864 Homeogene 9 Tablets Laboratoires BOIRON 31/12/07<br />

5865 Homeomag Tablets Lehning Laboratoires 30/06/07<br />

5866 Homeoplasmine Ointment Laboratoires BOIRON 31/12/07<br />

5867 Homeoptic Eye drops Laboratoires BOIRON 9/10/05<br />

5868 Homeotuss Syrup for children Laboratoires BOIRON 31/12/08<br />

5869 Homeovox Tablets Laboratoires BOIRON 31/12/07<br />

5870 Hoof-Pro Siarczan miedzi<br />

pie˛ciowodny, Siarka<br />

5871 Horacort Budesonidum Nasal spray,<br />

suspension<br />

Liquid for veterinary<br />

use<br />

5872 Horacort forte Budesonidum Pressurised inhalation,<br />

suspension<br />

5873 Horacort mite Budesonidum Pressurised inhalation,<br />

suspension<br />

SSI Corporation Production<br />

Facility<br />

12/07/07<br />

50 mcg/dawke˛ Instytut Farmaceutyczny 31/12/08<br />

160 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

Instytut Farmaceutyczny 30/11/05<br />

50 mcg/dawke˛ Instytut Farmaceutyczny 31/12/08<br />

5874 Hormeel SN Amp. Heel GmbH 31/12/07<br />

5875 Hormeel SN Drops Heel GmbH 31/12/07<br />

5876 Hostamox LA Amoxicillunum Suspension for veterinary<br />

use<br />

Intervet International 31/12/08<br />

5878 Hotemin Piroxicamum Capsules 10 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

5879 Hotemin Piroxicamum Capsules 20 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

5877 Hotemin Piroxicamum Injection 20 mg/1 ml Egis Pharmaceuticals Ltd. 31/12/08<br />

5880 Hotigal Preparat złoz˙ony Cream Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego ‘CEFARM’,<br />

Gdańsk<br />

5881 Hova Lupuli flos extractum<br />

siccum + Valerianae<br />

radix extractum siccum<br />

31/12/08<br />

Film-coated tablets P.P.H.U. Biofarm Sp. z o.o. 31/01/05<br />

5882 H-Pantoten Preparat złoz˙ony Tablets Carls-Bergh Pharma ab 30/08/04<br />

5883 HumaJect M2 (20:80) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5884 HumaJect M3 (30:70) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

Suspension for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

Suspension for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

100 j.m./ml Lilly France S.A. 31/12/08<br />

100 j.m./ml Lilly France S.A. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1013<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5885 HumaJect N Insulinum isophanum Suspension for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

5886 HumaJect R Insulini injectio neutralis Solution for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

5887 Humalog Insulini injectio neutralis<br />

lisprum<br />

5888 Humalog Insulini injectio neutralis<br />

lisprum<br />

5889 Humalog Mix 25 Insulini injectio neutralis<br />

lisprum + Insulinum<br />

lisprum zinci protaminati<br />

injectio<br />

5890 Humalog Mix 25 Insulini injectio neutralis<br />

lisprum + Insulinum<br />

lisprum zinci protaminati<br />

injectio<br />

5891 Humalog Mix 25 HumaJect Insulini injectio neutralis<br />

lisprum + Insulinum<br />

lisprum zinci protaminati<br />

injectio<br />

5892 Humalog Mix 25 Pen Insulini injectio neutralis<br />

lisprum + Insulinum<br />

lisprum zinci protaminati<br />

injectio<br />

5893 Humalog Mix 50 Insulini injectio neutralis<br />

lisprum + Insulinum<br />

lisprum zinci protaminati<br />

injectio<br />

5894 Humalog Mix 50 Pen Insulini injectio neutralis<br />

lisprum + Insulinum<br />

lisprum zinci protaminati<br />

injectio<br />

5895 Humalog Pen Insulini injectio neutralis<br />

lisprum<br />

Solution for<br />

subcutanous injection<br />

Solution for<br />

subcutanous injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

5896 Human Albumin 5 % Albuminum Solution for<br />

intravenous infusion<br />

5897 Human Albumin 5 % Albuminum humanum Solution for<br />

intravenous infusion<br />

5898 Human Albumin 20 % Albuminum Solution for<br />

intravenous infusion<br />

5899 Human Albumin 20 % Albuminum Solution for<br />

intravenous infusion<br />

5900 Human Albumin 20 % Albuminum Solution for<br />

intravenous infusion<br />

5901 Human Albumin 20 % Albuminum humanum Solution for injection<br />

or intravenous<br />

infusion<br />

5902 HUMAN HEMIN ORPHAN<br />

EUROPE 25 mg/ml<br />

5903 Humana SL Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

Hemina ludzka Concentrate for<br />

solution for infusion<br />

100 j.m./ml Lilly France S.A. 31/12/08<br />

100 j.m./ml Lilly France S.A. 31/12/08<br />

100 j.m./ml Lilly France S.A. 13/12/06<br />

100 j.m./ml Lilly France S.A. 13/12/06<br />

100 j.m. Lilly France S.A. 31/12/04<br />

100 j.m./ml Lilly France S.A. 31/12/04<br />

100 j.m./ml Lilly France S.A. 31/12/04<br />

100 j.m./ml Lilly France S.A. 31/12/04<br />

100 j.m./ml Lilly France S.A. 31/12/04<br />

100 j.m./ml Lilly France S.A. 31/12/04<br />

100 j.m./ml Lilly France S.A. 31/12/04<br />

50 mg/ml Biotest Pharma GmbH 31/07/04<br />

50 mg/ml Baxter AG 31/07/04<br />

200 mg/1 ml Centeon Pharma GmbH 31/07/04<br />

200 mg/ml Biotest Pharma GmbH 31/07/04<br />

200 mg/ml Instituto Grifols S.A. 31/01/05<br />

200 mg/ml Baxter AG 31/07/04<br />

25 mg/ml Orphan Europe 31/12/08<br />

Powder Milchwerke Westfalen eG 30/01/05


EN<br />

1014 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5904 Humana z MCT Dieta z MCT Powder Milchwerke Westfalen eG 31/12/04<br />

5908 Humatrope Somatropinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

5909 Humatrope Somatropinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

5905 Humatrope Somatropinum Lyophilisate for<br />

injection<br />

5906 Humatrope Somatropinum Lyophilisate for<br />

injection<br />

5907 Humatrope Somatropinum Lyophilisate for<br />

injection<br />

5910 Humegon Human menopausal<br />

gonadotropin<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

4 j.m. (<br />

1.33 mg)<br />

5.33 mg (<br />

16 j.m.)<br />

Lilly France S.A. 31/07/04<br />

Lilly France S.A. 31/07/05<br />

12 mg (36 j.m) Lilly France S.A. 31/12/08<br />

24 mg (72 j.m.) Lilly France S.A. 31/12/08<br />

6 mg (18 j.m.) Lilly France S.A. 31/12/08<br />

75 j.m. Organon N.V. —<br />

Kloosterstraat<br />

30/06/04<br />

5911 Humoxal Preparat złoz˙ony Nasal drops Laboratoires URGO 31/12/08<br />

5912 Humulin L Insulini cum zinco<br />

suspensio<br />

5913 Humulin L Insulini cum zinco<br />

suspensio<br />

5914 Humulin M2 (20/80) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5915 Humulin M2 (20/80) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5916 Humulin M3 (30/70) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5917 Humulin M3 (30/70) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5918 Humulin M3 (30/70) Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

5919 Humulin M3 Pen Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

injection<br />

5920 Humulin N Insulinum isophanum Suspension for<br />

injection<br />

5921 Humulin N Insulinum isophanum Suspension for<br />

injection<br />

5922 Humulin N Insulinum isophanum Suspension for<br />

injection<br />

5923 Humulin N Pen Insulinum isophanum Suspension for<br />

injection<br />

100 j.m./ml Lilly France S.A. 31/07/04<br />

40 j.m./ml Lilly France S.A. 31/07/04<br />

100 j.m/ml Lilly France S.A. 31/07/04<br />

40 j.m./ml Lilly France S.A. 31/07/04<br />

100 j.m./ml Lilly France S.A. 31/07/04<br />

40 j.m./ml Lilly France S.A. 31/07/04<br />

100 j.m./ml Lilly France S.A. 30/06/05<br />

100 j,m. Lilly France S.A. 31/12/04<br />

100 j.m./ml Lilly France S.A. 31/07/04<br />

100 j.m./ml Lilly France S.A. 31/07/04<br />

40 j.m./ml Lilly France S.A. 31/07/04<br />

100 j.m./ml Lilly France S.A. 31/12/04<br />

5924 Humulin R Insulini injectio neutralis Solution for injection 100 j.m./ml Lilly France S.A. 31/07/04<br />

5925 Humulin R Insulini injectio neutralis Solution for injection 100 j.m./ml Lilly France S.A. 31/07/04<br />

5926 Humulin R Insulini injectio neutralis Solution for injection 40 j.m./ml Lilly France S.A. 31/07/04<br />

5927 Humulin R Pen Insulini injectio neutralis Solution for injection 100 j.m. Lilly France S.A. 31/12/04<br />

5928 Humulin U Insulini cum zinco<br />

suspensio<br />

Suspension for<br />

injection<br />

100 j.m./ml Lilly France S.A. 31/07/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1015<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5929 Humulin U Insulini cum zinco<br />

suspensio<br />

Suspension for<br />

injection<br />

40 j.m./ml Lilly France S.A. 31/07/04<br />

5930 Husk Plantaginis ovatae testa Oral powder Werner Ratje Froskaller 26/04/06<br />

5931 Hustagil Preparat złoz˙ony Ointment Dentinox Gesellschaft fur<br />

pharmaceutische Praparate<br />

Lenk & Schuppan<br />

5932 Hustagil -krople tymiankowe Thymi extractum fluidum Oral drops, solution 900 mg/ml Dentinox Gesellschaft fur<br />

pharmaceutische Praparate<br />

Lenk & Schuppan<br />

5933 Hustagil -syrop<br />

przeciwkaszlowy<br />

Thymi extractum fluidum Syrup 480 mg/5ml Dentinox Gesellschaft fur<br />

pharmaceutische Praparate<br />

Lenk & Schuppan<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

5934 Husteel Drops Heel GmbH 31/12/07<br />

5935 Hyalgan Acidum hyaluronicum Solution for articular<br />

injection<br />

5936 Hycamtin Topotecanum Powder for solution<br />

for intravenous<br />

injection<br />

5937 Hydacorn Coffeinum +<br />

Dihydroergotaminum +<br />

Phenytoinum<br />

10 mg/ml Fidia S.p.A. Common<br />

Pharmaceutical<br />

4 mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

Coated tablets Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

5938 Hydiphen Clomipraminum Coated tablets 25 mg AWD.pharma GmbH & Co.<br />

KG<br />

5939 Hydiphen Clomipraminum Coated tablets 10 mg AWDpharma GmbH & Co.<br />

KG<br />

5940 Hydrochlorothiazidum Hydrochlorothiazidum Tablets 12.5 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

5941 Hydrochlorothiazidum Hydrochlorothiazidum Tablets 25 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/06/04<br />

30/05/05<br />

31/12/06<br />

31/07/04<br />

30/09/07<br />

6/11/05<br />

6/11/05<br />

5942 Hydrochlorothiazidum Hydrochlorothiazidum Tablets 25 mg Labpharm Sp. z o.o. 31/12/08<br />

5943 Hydrochlorothiazidum Hydrochlorothiazidum Tablets 12,5 mg Labpharm Sp. z o.o. 31/12/08<br />

5944 Hydrocortisonum Hydrocortisonum Cream 0,50 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5945 Hydrocortisonum Hydrocortisonum Cream 1 % Homeofarm Sp. z o.o.<br />

Laboratorium<br />

Farmaceutyczne<br />

5946 Hydrocortisonum Hydrocortisonum Tablets 20 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

5947 Hydrocortisonum Hydrocortisonum +<br />

Lidocainum<br />

Suspension for<br />

injection<br />

(25mg + 5mg)/<br />

ml<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

5948 Hydrocortisonum 0,5 % Hydrocortisonum Cream 5 mg/g Aflofarm Farmacia Polska Sp.<br />

z o.o.<br />

5949 Hydrocortisonum 1 % Hydrocortisonum Cream 1 % Laboratorium Galenowe<br />

‘LEFARM’ Sp. z o.o.<br />

5950 Hydrocortisonum 1 % Hydrocortisonum Cream 10 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

5951 Hydrocortisonum 1 % Hydrocortisonum Cream 10 mg/g Aflofarm Farmacia Polska Sp.<br />

z o.o.<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

30/11/05<br />

27/06/07<br />

31/12/08<br />

30/11/05<br />

27/06/07


EN<br />

1016 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5952 Hydrocortisonum<br />

hemisuccinatum<br />

5953 Hydrocortisonum<br />

hemisuccinatum<br />

5954 Hydrocortisonum<br />

hemisuccinatum<br />

Hydrocortisonum Solution for injection 20 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Hydrocortisonum Solution for injection 25 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Hydrocortisonum Solution for injection<br />

or for intravenous<br />

infusion<br />

100 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

5956 Hydrocortisonum Solubile Hydrocortisonum Powder and solvent 500 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5957 Hydrocortisonum Solubile Hydrocortisonum Powder and solvent 100 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5958 Hydrocortisonum Solubile Hydrocortisonum Powder and solvent 25 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

5955 Hydrocortisonum Solubile Hydrocortisonum Powder and solvent<br />

for solution for<br />

injection or<br />

intravenous infusion<br />

5959 Hydrodiar Glucosum + Natrii<br />

chloridum<br />

Powder for veterinary<br />

use<br />

250 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

25/01/06<br />

Biofaktor 31/12/08<br />

5960 Hydrokortyzon Hydrocortisonum Farm-Impex s.j., Gliwice 31/12/07<br />

5961 Hydrokortyzon Hydrocortisonum Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

31/12/07<br />

5962 Hydrokortyzon Hydrocortisonum Lefarm, Bydgoszcz 31/12/07<br />

5963 Hydrokortyzon Hydrocortisonum Pharma Cosmetic, Kraków 31/12/07<br />

5964 Hydrokortyzon Hydrocortisonum Pharma Zentrale 31/12/07<br />

5965 Hydrokortyzon Hydrocortisonum Polfa Pabianice 31/12/07<br />

5966 Hydrokortyzon Hydrocortisonum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

5967 Hydroksyetyloskrobia 200/0,5 Hydroxyethylamylum Liquid for intravenous<br />

infusion<br />

5968 Hydroksyetyloskrobia 200/0,5 Hydroxyethylamylum Liquid for intravenous<br />

infusion<br />

31/12/07<br />

6 % Baxter Terpol Sp. z o.o. 31/12/07<br />

10 % Baxter Terpol Sp. z o.o. 31/12/07<br />

5969 Hydroksyzyna Hydroxyzinum Syrup 10 mg/5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5970 Hydroxoxyurea medac Hydroxycarbamidum Capsuels, hard 500 mg medac Gesellschaft fur<br />

Klinische Spezialpraparate<br />

mbH<br />

5971 Hydroxycarbamid Hydroxycarbamidum Capsules 500 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/04/05<br />

6/06/07<br />

31/12/05<br />

5972 Hydroxyzidum Hydroxizidum Syrup 10 mg /5ml Aflofarm 31/12/08<br />

5977 Hydroxyzinum Hydroxyzinum Coated tablets 10 mg Aflofarm 31/12/08<br />

5978 Hydroxyzinum Hydroxyzinum Coated tablets 25 mg Aflofarm 31/12/08<br />

5975 Hydroxyzinum Hydroxyzinum Film-coated tablets 10 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

5976 Hydroxyzinum Hydroxyzinum Film-coated tablets 25 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

5973 Hydroxyzinum Hydroxyzinum Solution for injection 50 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/11/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1017<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

5974 Hydroxyzinum Hydroxyzinum Syrup 1.6 mg/g Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp. z<br />

o.o.<br />

31/01/06<br />

5979 Hygroton Chlortalidonum Tablets 50 mg Novartis Pharma AG 31/05/04<br />

5980 Hyo — 50 sól sodowa dwasu<br />

hialuronowego<br />

Solution for veterinary<br />

use<br />

5981 Hyonate Hialuronian sodu Solution for veterinary<br />

use<br />

5982 Hyoresp Szczepionka dla s´wiń<br />

przeciw zakaz˙eniom<br />

wywoływanym przez<br />

Mycoplasma<br />

hyopneumoniae<br />

Suspension for veterinary<br />

use<br />

Bexo Pharma Inc. 31/12/08<br />

Bayer AG 11/03/07<br />

Merial 25/08/05<br />

5983 Hypaque Meglumine 60 % Meglumini amidotrizoas Solution for injection 600 mg/ml Amersham Health AS 31/12/08<br />

5984 Hypaque Meglumine 76 % Meglumini amidotrizoas<br />

+ Natrii amidotrizoas<br />

5985 Hypercaps Hyperici extractum<br />

siccum<br />

5986 Hypercin Hyperici herbae<br />

extractum sicc.<br />

Solution for injection 760 mg/ml Amersham Health AS 31/12/08<br />

Capsules, hard Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

Tablets 180 mg Pharbio Medical Sverige AB 31/12/08<br />

5987 Hypercin 270 Hyperici extractum Tablets 270 mg Pharbio Medical Sverige AB 31/12/08<br />

5988 Hypercin 90 Hyperici extractum Tablets 90 mg Pharbio Medical Sverige AB 31/12/08<br />

5989 Hyperherba Hyperici herba Tablets 330 mg Labofarm — Innowacyjno-<br />

Wdroz˙eniowe Laboratorium<br />

Farmaceutyczne<br />

5990 Hyperiforce Hyperici herbae<br />

extractum siccum<br />

5991 Hyperosedat Hyperici herbae<br />

extractum siccum<br />

31/01/05<br />

Tablets 0.33 mg Bioforce AG 25/10/06<br />

Capsules, soft 80 mg Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

27/06/07<br />

5992 Hypertosan Herba Oskar, Wierzbówiec 31/12/08<br />

5993 Hypnogen Zolpidemi tartas Film-coated tablets 10 mg Lečiva a.s. 14/02/07<br />

5994 Hypnomidate Etomidatum Solution for injection 2 mg/ml Janssen Pharmaceutica N.V. 30/06/04<br />

5995 HYPOPHYSIS/STANNUM<br />

ampułki<br />

5996 HYPOPHYSIS/STANNUM<br />

granulki<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

5997 Hytrin Terazosinum Tablets 10 mg Abbott Laboratories Ltd. 31/12/08<br />

5998 Hytrin Terazosinum Tablets 2 mg Abbott Laboratories Ltd. 31/12/08<br />

5999 Hytrin Terazosinum Tablets 5 mg Abbott Laboratories Ltd. 31/12/08<br />

6000 Hytrin Terazosinum Tablets Abbott Laboratories Ltd. 31/12/08<br />

6001 Hyzaar Hydrochlorothiazidum +<br />

Losartanum<br />

6002 IBA-VAC Szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu torby<br />

Fabrycjusza<br />

Film-coated tablets 12,5mg +<br />

50mg<br />

Lyophilisate for veterinary<br />

use<br />

Merck Sharp & Dohme Idea<br />

Inc.<br />

30/09/04<br />

FATRO 21/02/05


EN<br />

1018 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6003 Iberogast Preparat złoz˙ony Oral solution Steigerwald Arzneimittelwerk<br />

GmbH<br />

6004 Ibiprofenum Z˙el Ibuprofenum Gel 5 % PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

6005 Ibu — Hepa Ibuprofenum +<br />

Heparinoidum<br />

Cream (50 mg +<br />

2 mg)/g<br />

31/12/08<br />

31/12/08<br />

Leciva Inc. 31/12/08<br />

6010 Ibufen Ibuprofenum Gel 100mg/g Medana Pharma Terpol<br />

Group S.A.<br />

6009 Ibufen Ibuprofenum Oral suspension 0.1 g/5 ml Medana Pharma Terpol<br />

Group S.A.<br />

6006 Ibufen Ibuprofenum Suppository 50 mg TERPOL Przedsiebiorstwo<br />

Farmaceutyczne S.A<br />

6007 Ibufen Ibuprofenum Suppository 100 mg TERPOL Przedsiebiorstwo<br />

Farmaceutyczne S.A<br />

6008 Ibufen Ibuprofenum Suppository 250 mg TERPOL Przedsiebiorstwo<br />

Farmaceutyczne S.A<br />

6011 Ibufen C Ibuprofenum + Acidum<br />

ascorbicum<br />

Film-coated tablets 200 mg +<br />

125 mg<br />

Medana Pharma TERPOL<br />

Group S.A.<br />

6012 Ibum Ibuprofenum Capsules, soft 200 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

6014 Ibum Ibuprofenum Gel for external use 5 mg ibuprofen;<br />

3 mg mentol /<br />

100 g<br />

6013 Ibum Ibuprofenum Oral suspension for<br />

children and infant<br />

6015 Ibum Extra Ibuprofenum +<br />

Pseudoephedrinum<br />

Film-coated tablets 200 mg +<br />

30 mg<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

100 mg/5 ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

6016 Ibum Forte Ibuprofenum Capsules, soft 400 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

26/09/07<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

27/06/07<br />

31/12/08<br />

27/06/07<br />

31/12/08<br />

31/12/08<br />

6017 Ibumac Ibuprofenum Coated tablets 200 mg US Pharmacia 31/12/08<br />

6018 Ibumetin retard Ibuprofenum Prolonged release<br />

tablets<br />

600 mg Nycomed Danmark A/S 31/12/08<br />

6019 Ibuprofen Ibuprofenum Capsules, soft 200 mg Specjalistyczne<br />

Przedsie˛biorstwo Rolno-<br />

Przetwórcze ‘GAL’ s.c.<br />

6020 Ibuprofen Ibuprofenum Film-coated tablets 200 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

31/12/05<br />

6021 Ibuprofen Ibuprofenum Film-coated tablets 200 mg Polfarmex S.A 29/06/05<br />

6022 Ibuprofen Ibuprofenum Film-coated tablets 200 mg Aflofarm Fabryka Leków Sp.<br />

z o.o.<br />

6023 Ibuprofen Ibuprofenum Gel 10 % TERPOL Przedsiebiorstwo<br />

Farmaceutyczne S.A<br />

6024 Ibuprofen Ibuprofenum Gel 50 mg/g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

6025 Ibuprofen 200 Ibuprofenum Film-coated tablets 200 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

31/12/08<br />

10/05/06<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1019<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6026 Ibuprofen 400 Ibuprofenum Film-coated tablets 400 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

6027 Ibuprom Ibuprofenum Film-coated tablets 200 mg US Pharmacia International<br />

Inc.<br />

31/12/08<br />

30/04/04<br />

6028 Ibuprom Max Ibuprofenum Coated tablets 400 mg US Pharmacia Sp. z o.o. 30/09/07<br />

6029 Ibuprom Max Ibuprofenum Film-coated tablets 400 mg US Pharmacia Sp. z o.o. 26/09/07<br />

6030 IBUPROM® Przezie˛bienie i<br />

Grypa<br />

Ibuprofenum +<br />

Pseudoephedrinum<br />

Film-coated tablets 200 mg +<br />

30 mg<br />

US Pharmacia International,<br />

Inc.<br />

31/12/08<br />

6031 Ibusan 200 Ibuprofenum Film-coated tablets 200 mg Sanofi Winthrop-Gentilly 30/06/05<br />

6032 Ibusan 400 Ibuprofenum Film-coated tablets 400 mg Sanofi Winthrop-Gentilly 30/06/05<br />

6033 Ibusan 600 Ibuprofenum Film-coated tablets 600 mg Sanofi Winthrop-Gentilly 30/03/05<br />

6034 Ibustrin Indobufenum Tablets 200 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

6035 Ichtio Zieleń malachitowa,<br />

błe˛kit metylenowy,<br />

zieleń brylantowa,<br />

EDTA, sól dwusodowa<br />

6036 Ichtio Forte Zieleń malachitowa,<br />

błe˛kit metylenowy,<br />

zieleń brylantowa,<br />

EDTA, sól dwusodowa<br />

6037 Ichtioseptin Akryflawiny chlorek,<br />

zieleń malachitowa,<br />

błe˛kit metylenowy,<br />

EDTA, sól dwusodowa<br />

6038 Ichtioseptin Forte Akryflawiny chlorek,<br />

zieleń malachitowa,<br />

błe˛kit metylenowy,<br />

EDTA, sól dwusodowa<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

6039 Ichtioxan Oxytetracyclinum Powder for veterinary<br />

use<br />

30/04/04<br />

Przedsie˛biorstwo Tropical 31/12/08<br />

Przedsie˛biorstwo Tropical 18/09/07<br />

Przedsie˛biorstwo Tropical 31/12/08<br />

Przedsie˛biorstwo Tropical 18/09/07<br />

Interbiowet 31/12/07<br />

6040 Iclopid Ticlopidinum Film-coated tablets 250 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

6041 Icy Rub Gel Gel Kato LABS Sp. z o.o. 28/02/06<br />

6042 Ideos Calcii carbonas +<br />

Colecalciferolum<br />

Buccal tablet 500 mg Ca++ Laboratoire Innotech<br />

International<br />

6043 Ifapidin Ticlopidinum Film-coated tablets 250 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

6044 Ifosfamid Ifosfamidum Lyophilisate for<br />

solution for injection<br />

500mg i<br />

1000 mg<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

6045 Ignatia-Dagomed 14 stres DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

30/09/05<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

6046 Ignatia-Homaccord Amp. Heel GmbH 31/12/07<br />

6047 Ignatia-Homaccord Drops Heel GmbH 31/12/07<br />

6048 Ikapril Moexiprilum Film-coated tablets 7,5 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

6049 Ikapril Moexiprilum Film-coated tablets 15 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

31/12/08


EN<br />

1020 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6050 Ikapril Plus Moeksprilum+<br />

Hydrochlorothiazidum<br />

Tablets 7,5 mg +<br />

12,5 mg<br />

6051 Ilomedin Iloprostum Concantrate for<br />

solution for<br />

intravenous infusion<br />

6052 Ilomedin 20 Iloprostum Concantrate for<br />

solution for<br />

intravenous infusion<br />

6053 Imaverol Enilkonazolum Solution for veterinary<br />

use<br />

6054 Imectin iwermektyna Solution for veterinary<br />

use<br />

6055 Imequyl 10 % Flumechina Powder for veterinary<br />

use<br />

Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

50 mcg/0,5 ml Schering AG 31/12/08<br />

20 mcg/ml Schering AG 13/05/07<br />

Janssen Pharmaceutica 12/06/05<br />

Bimeda 31/12/08<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

6059 Imigran Sumatriptanum Film-coated tablets 100 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

6060 Imigran Sumatriptanum Film-coated tablets 25 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

6061 Imigran Sumatriptanum Film-coated tablets 50 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

6056 Imigran Sumatriptanum Nasal spray, solution 20 mg/0,1 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

6058 Imigran Sumatriptanum Solution for injection 12 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

6057 Imigran Sumatriptanum Suppository 25 mg Glaxo Wellcome House,<br />

Glaxo Wellcome Group<br />

6062 Imipramin Imipraminum Coated tablets 10 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

6063 Imipramin Imipraminum Coated tablets 25 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

6064 Imipramin Imipraminum Solution for injection 12.5 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

6065 Imivet Imidachlopryd Liquid for veterinary<br />

use<br />

6066 Imizol Imidokarbu<br />

dipropionian<br />

6067 Immucox C1 Szczepionka przeciw<br />

kokcydiozie kurcza˛t<br />

brojlerów<br />

6068 Immucox C2 Szczepionka przeciw<br />

kokcydiozie kurcza˛t<br />

hodowlanych<br />

6069 Immucox T1 Szczepionka przeciw<br />

kokcydiozie brojlerów<br />

indyczych<br />

6070 Immucyst (Immunoterapeutyk<br />

BCG)<br />

Solution for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Vaccinum BCG Powder and solvent<br />

for suspension for<br />

intrabladder use<br />

81 mg pra˛tków<br />

BCG<br />

10/06/04<br />

30/06/04<br />

31/12/07<br />

31/05/05<br />

31/05/05<br />

30/06/04<br />

30/09/07<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

Vet-Agro 31/12/08<br />

Schering-Plough Central East<br />

Ag<br />

17/05/05<br />

Vetech Laboratories 31/12/08<br />

Vetech Laboratories 31/12/08<br />

Vetech Laboratories 31/12/08<br />

Aventis Pasteur Limited 31/12/08<br />

6071 Immunal Oral drops, solution 800 mg/ml Lek Pharmaceuticals d.d. 30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1021<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6072 Immunal® Echinaceae purpureae<br />

herbae succus siccum<br />

6073 Immunate STIM Plus Coagulation factor VIII Lyophilisate for<br />

intravenous use<br />

6074 Immunate STIM Plus Coagulation factor VIII Lyophilisate for<br />

intravenous use<br />

6075 Immunate STIM Plus Coagulation factor VIII Lyophilisate for<br />

intravenous use<br />

6076 Immunine Coagulation factor IX Lyophilisate for<br />

intravenous use<br />

6077 Immunine Coagulation factor IX Lyophilisate for<br />

intravenous use<br />

Tablets 80 mg Lek Polska Sp. z o.o. 31/12/08<br />

1000 j.m. Baxter AG 31/12/08<br />

250 j.m. Baxter AG 31/12/08<br />

500 j.m. Baxter AG 31/12/08<br />

1200 j.m. Baxter AG 31/12/08<br />

600 j.m. Baxter AG 31/12/08<br />

6078 Immunofort Oral solution Dar Natury P.P.H. 31/12/05<br />

6079 Immunoglobulina<br />

przeciwte˛z˙cowa Grifols<br />

250 j.m.<br />

6080 Immunoglobulina<br />

przeciwte˛z˙cowa Grifols<br />

500 j.m.<br />

Immunoglobulinum<br />

humanum tetanicum<br />

Immunoglobulinum<br />

humanum tetanicum<br />

6081 Immunoglobuline I.V. Immunoglobulinum<br />

humanum normace ad<br />

usum intravenosum<br />

6082 Immunosol Jez˙ówka, wycia˛g z<br />

róz˙y<br />

6083 Immunostymulant BCG<br />

ImmuCyst<br />

Solution for injection 250 j.m./ml Instituto Grifols S.A. 31/12/08<br />

Solution for injection 500 j.m./ml Instituto Grifols S.A. 31/12/08<br />

Powder for solution<br />

for infusion<br />

Tuberculinum Lyophilisate for<br />

injection<br />

6084 Immunovac Inaktywowana<br />

szczepionka dla kur<br />

przeciw zakaz˙eniom<br />

wywołanym przez<br />

pałeczki Salmonella<br />

6085 Immunovit Koncentrat z jez˙ówki<br />

purpurowej,<br />

koncentrat z korzenia<br />

z˙eńszenia, metionina,<br />

witamina e, c, b6<br />

6086 Imocolibov Inaktywowana<br />

szczepionka dla krów i<br />

owiec przeciw<br />

kolibakteriozie ciela˛t i<br />

jagnia˛t<br />

Liquid for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Tablets for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

5 g Sanquin, CLB Products<br />

Division<br />

31/12/08<br />

Biowet Puławy 31/12/08<br />

Aventis Pasteur Limited 31/12/07<br />

Zakład Badawczo-<br />

Wdroz˙eniowy Os´rodka<br />

Salmonella Immunolab Sp.z<br />

o.o.<br />

15/05/04<br />

Biowet Puławy 31/12/08<br />

Merial 28/02/05<br />

6087 Imodium Loperamidum Capsules 2 mg Janssen Pharmaceutica N.V. 31/07/04<br />

6088 Imodium Instant Loperamidum Tablets (oral<br />

lyophilisate)<br />

6089 Imodium Plus Loperamidum +<br />

Simeticonum<br />

2 mg Janssen Pharmaceutica N.V. 15/11/06<br />

Chewable tablets 2mg + 125mg Janssen-Cilag N.V. 25/10/06<br />

6090 Imovane Zopiclonum Film-coated tablets 7.5 mg Rhône-Poulenc Rorer Specia 30/06/04<br />

6091 Imovax Polio Poliomyelitis, trivalent,<br />

inactivated, whole virus<br />

Suspension for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

0.5 ml Aventis Pasteur S.A. 29/02/04<br />

6092 Impact Dieta płynna Novartis 31/12/08


EN<br />

1022 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6093 Implanon Etonogestrelum Implant Organon 31/12/08<br />

6094 Imukin Interferonum gamma Solution for<br />

subcutanous injection<br />

200 mcg/ml Boehringer Ingelheim<br />

International GmbH<br />

6096 Imuran Azathioprinum Film-coated tablets 25 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

6097 Imuran Azathioprinum Film-coated tablets 50 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

6095 Imuran Azathioprinum Lyophilisate for<br />

solution for injection<br />

50 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

28/10/06<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

6098 Indap Indapamidum Capsules 2,5 mg PRO. MED. C.S., Praha a.s. 31/12/08<br />

6099 Indapamid Sr Indapamidum Prolonged release<br />

tablets<br />

1,5 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/12/08<br />

6100 Indapamid Sr Film-coated tablets 1,5 mg MARCPHARM S.p. z.o.o. 31/12/08<br />

6101 Indapamid SR Anpharm Indapamidum Film-coated, prologed<br />

release tablets<br />

6102 Indapamide Indapamidum Prolonged release<br />

tablets<br />

1,5 mg Anpharm S.A. 4/07/07<br />

1,5g PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

6103 Indapen Indapamidum Film-coated tablets 2.5 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

6104 Indapres Indapamidum Film-coated tablets 2.5 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

6105 Indapres Indapamidum Film-coated tablets 1,25 mg Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

6106 Indapsan Indapamidum Film-coated tablets 2.5 mg Sanofi Winthrop-Gentilly<br />

Cedex<br />

6107 Indium (111 In) Chloride Preparat<br />

radiofarmaceutyczny<br />

6108 Indium (111 In) Oxinate Preparat<br />

radiofarmaceutyczny<br />

6109 Indivina Estradiolum +<br />

Medroxyprogesteronum<br />

6110 Indivina Estradiolum +<br />

Medroxyprogesteronum<br />

6111 Indivina Estradiolum +<br />

Medroxyprogesteronum<br />

31/12/08<br />

8/02/06<br />

27/09/06<br />

31/12/08<br />

31/12/08<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Tablets 1 mg/5 mg Orion Pharma A/S 31/12/08<br />

Tablets 1 mg/2,5 mg Orion Pharma A/S 31/12/08<br />

Tablets 2 mg/5 mg Orion Pharma A/S 31/12/08<br />

6114 Indobufen Indobufenum Powder and solvent 200 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

6112 Indobufen Indobufenum Powder for solution<br />

for intravenous<br />

injections<br />

6113 Indobufen Indobufenum Powder for solution<br />

for intravenous<br />

injections<br />

100 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

200 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/12/08<br />

25/04/07<br />

31/12/08<br />

6115 Indobufen Indobufenum Tablets 200 mg Instytut Farmaceutyczny 31/12/08<br />

6116 Indobufen Indobufenum Tablets 200 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

25/04/07<br />

6117 Indocollyre 0,1 % Indometacinum Eye drops Laboratoire Chauvin 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1023<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6118 Infacol Simeticonum Oral suspension 40 mg/ml Pharmax Ltd. 31/05/05<br />

6119 Infanrix DTPa Diphtheria-tetanuspertussis<br />

6120 Infanrix Hep B Diphtheria-tetanuspertussis<br />

+ Hepatitis B,<br />

purified antigen<br />

Suspension for<br />

intramuscular<br />

injection<br />

Suspension for<br />

intramuscular<br />

injection<br />

6121 Infanrix hexa Suspension and<br />

powder for<br />

suspension for<br />

injection<br />

6122 Infanrix IPV + Hib Diphtheria-hemophilus<br />

influenzae B-pertussispoliomyelitis-tetanus<br />

Suspension and<br />

powder for<br />

suspension for<br />

intramuscular<br />

injection<br />

6123 Infanrix penta Suspension for<br />

injection<br />

6124 Infectoflam Fluorometholonum +<br />

Gentamicinum<br />

6125 Infectoflam Fluorometholonum +<br />

Gentamicinum<br />

6126 Infectus Triptolidinum +<br />

Pseudoephedrinum +<br />

Dekstrometorphanum<br />

0.5 ml<br />

(1 dawka)<br />

SmithKline Beecham<br />

Biologicals<br />

0.5 ml SmithKline Beecham<br />

Biologicals<br />

1 dawka SmithKline Beecham<br />

Biologicals<br />

0.5 ml SmithKline Beecham<br />

Biologicals<br />

SmithKline Beecham<br />

Biologicals<br />

Eye drops Novartis Ophthalmics AG<br />

Hettlingen<br />

Eye ointment Novartis Ophthalmics AG<br />

Hettlingen<br />

Syrup (1,25 mg +<br />

30 mg +<br />

10 mg)/5 ml<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

6127 Infektoten fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp. z<br />

o.o. — Zastawna<br />

31/12/08<br />

30/06/05<br />

17/01/07<br />

21/06/06<br />

7/03/07<br />

31/10/04<br />

31/10/04<br />

31/12/08<br />

30/10/05<br />

6128 Infergen Interferonum alfacon-1 Solution for injection 9 mcg Yamanouchi Europe B.V. 25/05/05<br />

6129 Infludo krople WELEDA 24/08/05<br />

6130 Influtet Szczepionka przeciw<br />

grypie i te˛z˙cowi koni<br />

6131 Influvac 2002/2003 Influenza, inactivated,<br />

whole virus<br />

Suspension for veterinary<br />

use<br />

Suspension for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

6132 Infukoll-HES 10 % Hydroxyethylamylum Intravenous injection<br />

(solution for infusion)<br />

6133 Infukoll-HES 6 % Hydroxyethylamylum Intravenous injection<br />

(solution for infusion)<br />

6134 Ingelvac Aujeszky MLV Szczepionka dla s´wiń<br />

przeciw chorobie<br />

Aujeszkyego<br />

6135 Ingelvac M.hyo Inaktywowana<br />

szczepionka dla s´wiń<br />

przeciw<br />

mykoplazmowemu<br />

zapaleniu płuc<br />

6136 Ingelvac PRRS KV Szczepionka<br />

przeciwko zakaz˙eniom<br />

wirusem Zaspołu<br />

Rozrodczo-<br />

Oddechowego s´wiń<br />

45 mcg HA/<br />

0,5 ml<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Biowet Puławy 24/05/04<br />

Solvay Pharmaceuticals B.V. 23/11/05<br />

10 % Serum Werk Bernburg AG 31/12/08<br />

6 % Serum Werk Bernburg AG 31/12/08<br />

Boehringer Ingelheim 30/06/04<br />

Boehringer Ingelheim Animal<br />

Health GmbH<br />

24/07/07<br />

Boehringer Ingelheim 31/12/08


EN<br />

1024 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6137 Ingelvac PRRS MLV Z˙ywa, atenuowana<br />

szczepionka dla s´wiń<br />

przeciw oddechowej i<br />

rozrodczej formie<br />

zespołu rozrodczooddechowego<br />

s´wiń<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Boehringer Ingelheim 17/05/05<br />

6138 Inhalator donosowy ‘arfix’ Nasal spray Przeds. Prod.-Handl. Arf-Med<br />

S.C., Koszalin<br />

31/12/08<br />

6139 Inhal-Mix Inhalation drops Herbapol Lublin S.A. 31/12/07<br />

6140 Inhalol Preparat złoz˙ony Inhalation vapour,<br />

solution<br />

6141 Inhalsept Inhalation vapour,<br />

solution<br />

Profarm — Przedsie˛biorstwo<br />

Produkcji Farmaceutyczno-<br />

Kosmetycznej Sp. z o.o.<br />

Cefarm Gdańsk<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

6142 Inhibace Cilazaprilum Film-coated tablets 0.5 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

6143 Inhibace Cilazaprilum Film-coated tablets 1 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

6144 Inhibace Cilazaprilum Film-coated tablets 2.5 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

6145 Inhibace Cilazaprilum Film-coated tablets 5 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

6146 Inhibace Plus Cilazaprilum +<br />

Hydrochlorothiazidum<br />

Film-coated tablets Hoffmann La Roche Ltd.<br />

Bazylea<br />

6147 Inj. Adrenalini 0,1 % Adrenalinium Solution for injection 1 mg / 1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

6148 Inj. Adrenalini 0,1 % Epinephrinum Solution for injection 1 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

6149 Inj. Oxytocini Oxytocinum Solution for veterinary<br />

use<br />

6150 Inj. Polocaini hydrochlorici<br />

1%<br />

6151 Inj. Polocaini hydrochlorici<br />

2%<br />

30/10/05<br />

30/10/05<br />

31/05/04<br />

31/05/04<br />

31/05/04<br />

31/05/04<br />

31/08/05<br />

31/12/08<br />

31/12/08<br />

Biowet Puławy 30/06/04<br />

Procainum Solution for injection 10 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

Procainum Solution for injection 20 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

6152 Inj.Glucosi 20 % Glucosum Solution for veterinary<br />

use<br />

6153 Inj.Glucosi 40 % Glucosum Solution for veterinary<br />

use<br />

6154 Inj.Glucosi Isotonica Glucosum Solution for veterinary<br />

use<br />

6155 Injectio Coffeini Natrii<br />

Benzoici 20 %<br />

Coffeinum Solution for veterinary<br />

use<br />

6156 Injectio Glucosi 5 % Glucosum Solution for<br />

intravenous infusion<br />

6157 Injectio Glucosi 5 % et Natrii<br />

chlorati 0,9 % 1:1<br />

6158 Injectio Glucosi 5 % et Natrii<br />

chlorati 0,9 % 2:1<br />

Glucosum + Natrii<br />

chloridum<br />

Glucosum + Natrii<br />

chloridum<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

Zakłady Farmaceutyczne<br />

Biowet Sp. z o.o.<br />

Zakłady Farmaceutyczne<br />

Biowet Sp. z o.o.<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

31/01/05<br />

31/01/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

3/09/04<br />

50 mg/ml Baxter Terpol Sp. z o.o. 31/01/06<br />

(25mg +<br />

4,5mg)/ml<br />

(33,3mg +<br />

3mg)/ml<br />

Baxter Terpol Sp. z o.o. 31/01/06<br />

Baxter Terpol Sp. z o.o. 31/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1025<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6159 Injectio Glucosi 10 % Glucosum Solution for<br />

intravenous infusion<br />

6160 Injectio Glucosi 20 % Glucosum Solution for<br />

intravenous infusion<br />

6161 Injectio Glucosi 20 % Glucosum Solution for veterinary<br />

use<br />

6162 Injectio Glucosi 40 % Glucosum Solution for veterinary<br />

use<br />

100 mg/ml Baxter Terpol Sp. z o.o. 31/01/06<br />

200 mg/ml Baxter Terpol Sp. z o.o. 31/01/06<br />

Biowet Puławy 20/05/04<br />

Biowet Puławy 20/05/04<br />

6163 Injectio Glucosi 5 % Glucosum Solution for infusion 50 mg/ml Baxter Healthcare Ltd. 31/12/08<br />

6164 Injectio Glucosi 5 % Glucosum Solution for veterinary<br />

use<br />

Biowet Puławy 20/05/04<br />

6165 Injectio Glucosi 50 % Glucosum Solution for infusion 500 mg/ml Baxter Terpol Sp. z o.o. 31/12/08<br />

6166 Injectio Glucosi isotonica et<br />

Natrii chlorati isotonica 1:1<br />

6167 Injectio Glucosi Isotonica et<br />

Natrii Chlorati Isotonica 1:1<br />

6168 Injectio Glucosi isotonica et<br />

Natrii chlorati isotonica 2:1<br />

6169 Injectio Glucosi Isotonica et<br />

Natrii Chlorati Isotonica 2:1<br />

Glucosum + Natrii<br />

chloridum<br />

Glucosum + Natrii<br />

chloridum<br />

Glucosum + Natrii<br />

chloridum<br />

Glucosum + Natrii<br />

chloridum<br />

Solution for<br />

intravenous infusion<br />

Solution for veterinary<br />

use<br />

Solution for<br />

intravenous infusion<br />

Solution for veterinary<br />

use<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Lubelskie Zakłady<br />

Farmaceutyczne ‘Polfa’ Spółka<br />

Akcyjna<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Lubelskie Zakłady<br />

Farmaceutyczne ‘Polfa’ Spółka<br />

Akcyjna<br />

6170 Injectio Magnesii sulfurici 20 % Magnesii sulfas Solution for injection 200 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

6171 Injectio Magnesii sulfurici 25 % Magnesii sulfas Solution for injection 250 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

6172 Injectio Natrii chlorati 10 % Natrii chloridum Solution for<br />

intravenous infusion<br />

6173 Injectio Natrii chlorati<br />

isotonica<br />

100 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

Natrii chloridum Solution for injection 9 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

6174 Injectio Pyralgini Metanizolum Solution for veterinary<br />

use<br />

6175 Injectio Solutionis Ringeri Calcii chloridum + Kalii<br />

chloridum + Natrii<br />

chloridum<br />

6176 Injectio Solutionis Ringeri Calcii chloridum + Kalii<br />

chloridum + Natrii<br />

chloridum<br />

6177 Injectio Solutionis Ringeri Chlorek sodu, Chlorek<br />

potasu, Chlorek<br />

wapnia ,<br />

6178 Injectio Solutions Ringeri<br />

Lactate<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

(0,48mg +<br />

0,3mg +<br />

8,6mg)/ml<br />

Solution for veterinary<br />

use<br />

31/01/06<br />

19/12/06<br />

31/01/06<br />

19/12/06<br />

30/10/05<br />

30/10/05<br />

30/01/05<br />

31/01/06<br />

Biowet Puławy 31/12/08<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/06<br />

Baxter Terpol Sp. z o.o. 31/01/06<br />

Lubelskie Zakłady<br />

Farmaceutyczne ‘Polfa’ Spółka<br />

Akcyjna<br />

26/06/07<br />

Preparat złoz˙ony Solution for infusion Baxter Terpol Sp. z o.o. 31/12/08<br />

6179 Injeel-Chol Amp. Heel GmbH 31/12/08<br />

6180 Inmodulen immunomodulator Suspension for veterinary<br />

use<br />

6181 Inmunair 17,5 propionibacterium<br />

acnes liposacharydy z<br />

s´cian e.coli<br />

Suspension for veterinary<br />

use<br />

Laboratiorios Calier SA 31/12/08<br />

Laboratiorios Calier SA 31/12/08


EN<br />

1026 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6182 Inrektin fix Herbal tea 6.6 mg<br />

antranoidów<br />

6183 Insectin płyn Permetryna Liquid for veterinary<br />

use<br />

6184 Insectin proszek Permetryna Powder for veterinary<br />

use<br />

6185 Insektobójcza Zasypka PESS Bioresmetryna Powder for veterinary<br />

use<br />

6186 Insol Dermathopython szczepionka przeciwko<br />

klinicznej formie<br />

grzybicy skóry<br />

wywołanej przez<br />

grzyby z rodzaju<br />

Trichophyton spp. i<br />

Microsporum spp.<br />

6187 Instillagel Chlorhexidinum +<br />

Lidocainum<br />

6188 Insulatard HM Insulinum isophanum Suspension for<br />

injection<br />

6189 Insulatard HM Insulinum isophanum Suspension for<br />

injection<br />

6190 Insulatard HM Penfill Insulinum isophanum Suspension for<br />

injection<br />

6191 Insulatard Innolet Insulinum isophanum Suspension for<br />

injection<br />

6192 INSULATARD MC 100 J.M./Ml Insulinum isophanum Suspension for<br />

subcutaneous<br />

injection<br />

6193 INSULATARD MC 40 J.M./Ml Insulinum isophanum Suspension for<br />

subcutaneous<br />

injection<br />

6194 Insulatard NovoLet Insulinum isophanum Suspension for<br />

injection<br />

6195 Insulinum Iso-Mix 3 WO-S Insulinum isophanum<br />

biphasicum<br />

6196 Insulinum Iso-Mix 4 WO-S Insulinum isophanum<br />

biphasicum<br />

6197 Insulinum ISO-MIX 5 WO-S Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

Suspension for veterinary<br />

use<br />

Herbapol Lublin S.A. 31/12/07<br />

Biowet Puławy 21/06/04<br />

Biowet Puławy 26/04/04<br />

Wytwórnia Chemiczna PESS 9/11/04<br />

Boehringer Ingelheim 31/12/08<br />

Gel Farco Pharma GmbH 9/05/05<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

injection<br />

6198 Insulinum Isophanicum ChO-S Insulinum isophanum Suspension for<br />

injection<br />

6199 Insulinum Isophanicum WO-S<br />

alto depuratum<br />

6200 Insulinum Isophanicum WO-S<br />

alto depuratum<br />

6201 Insulinum Lente ChO-S Insulini cum zinco<br />

suspensio<br />

6202 Insulinum Lente WO-S alto<br />

depuratum<br />

Insulinum isophanum Suspension for<br />

injection<br />

Insulinum isophanum Suspension for<br />

injection<br />

Insulini cum zinco<br />

suspensio<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

100 j.m./ml Novo Nordisk A/S 30/04/05<br />

40 j.m./ml Novo Nordisk A/S 30/04/05<br />

100 j.m./ml Novo Nordisk A/S 30/04/05<br />

100 j.m./ml Novo Nordisk A/S 5/07/06<br />

100 j.m./ml Novo Nordisk A/S 31/12/08<br />

40 j.m./ml Novo Nordisk A/S 31/12/08<br />

100 j.m./ml Novo Nordisk A/S 8/01/06<br />

100 j.m/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

100 j.m/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

100 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

40 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

40 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

26/04/06<br />

26/04/06<br />

31/01/05<br />

31/12/05<br />

31/03/07<br />

28/02/06<br />

31/12/05<br />

24/03/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1027<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6203 Insulinum Lente WO-S alto<br />

depuratum<br />

Insulini cum zinco<br />

suspensio<br />

Suspension for<br />

subcutaneous<br />

injection<br />

80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

6204 Insulinum Maxirapid ChO-S Insulini injectio neutralis Solution for injection 80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

6205 Insulinum Maxirapid WO-S<br />

alto depuratum<br />

6206 Insulinum Maxirapid WO-S<br />

alto depuratum<br />

6207 Insulinum Semilente ChO-S Insulini cum zinco<br />

suspensio<br />

6208 Insulinum Semilente WO-S<br />

alto depuratum<br />

6209 Insulinum Semilente WO-S<br />

alto depuratum<br />

6210 Insulinum Solutio Neutralis<br />

ChO-S<br />

6211 Insulinum Solutio Neutralis<br />

WO-S alto depuratum<br />

6212 Insulinum Solutio Neutralis<br />

WO-S alto depuratum<br />

Insulini injectio neutralis Solution for injection 40 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Insulini injectio neutralis Solution for<br />

subcutanous injection<br />

Insulini cum zinco<br />

suspensio<br />

Insulini cum zinco<br />

suspensio<br />

6213 Insulinum Ultralente ChO-S Insulini cum zinco<br />

suspensio<br />

6214 Insulinum Ultralente WO-S<br />

alto depuratum<br />

6215 Insulinum Ultralente WO-S<br />

alto depuratum<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

40 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Insulini injectio neutralis Solution for injection 80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Insulini injectio neutralis Solution for injection 40 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Insulini injectio neutralis Solution for injection 80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Insulini cum zinco<br />

suspensio<br />

Insulini cum zinco<br />

suspensio<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

6216 Insuman Basal Insulinum isophanum Suspension for<br />

injection<br />

6217 Insuman Basal Insulinum isophanum Suspension for<br />

injection<br />

6218 Insuman Basal Insulinum isophanum Suspension for<br />

injection<br />

6219 Insuman Basal OptiSet Insulinum isophanum Suspension for<br />

injection<br />

6220 Insuman Comb 15 Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6221 Insuman Comb 15 Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6222 Insuman Comb 15 OptiSet Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6223 Insuman Comb 15/85 Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6224 Insuman Comb 15/85 Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

Suspension for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

40 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

80 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

40 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m Hoechst Marion Roussel<br />

Deutschland GmbH<br />

100 j.m./ml Hoechst Marion Roussel<br />

Deutschland GmbH<br />

28/02/06<br />

31/12/05<br />

31/03/07<br />

28/02/06<br />

31/12/05<br />

31/03/07<br />

28/02/06<br />

28/02/06<br />

31/03/07<br />

28/02/06<br />

31/12/05<br />

31/03/07<br />

30/04/05<br />

29/11/06<br />

29/11/06<br />

29/11/06<br />

21/03/06<br />

29/11/06<br />

29/11/06<br />

21/03/06<br />

31/03/04<br />

31/03/04


EN<br />

1028 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6225 Insuman Comb 25 Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6226 Insuman Comb 25 Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6<strong>227</strong> Insuman Comb 25 Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6228 Insuman Comb 25 OptiSet Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6229 Insuman Comb 50 Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6230 Insuman Comb 50 Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6231 Insuman Comb 50 OptiSet Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6232 Insuman Comb 50/50 Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

6233 Insuman Comb 50/50 Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

Suspension for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

40 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m. Aventis Pharma Deutschland<br />

GmbH<br />

100 j.m Hoechst Marion Roussel<br />

Deutschland GmbH<br />

100 j.m./ml Hoechst Marion Roussel<br />

Deutschland GmbH<br />

6234 Insuman Rapid Insulini injectio neutralis Solution for injection 100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

6235 Insuman Rapid Insulini injectio neutralis Solution for injection 100 j.m/ml Aventis Pharma Deutschland<br />

GmbH<br />

6236 Insuman Rapid Insulini injectio neutralis Solution for injection 40 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

6237 Insuman Rapid OptiSet Insulinum isophanum Solution for injection 100 j.m/ml Aventis Pharma Deutschland<br />

GmbH<br />

6240 Intal Acidum cromoglicicum Inhalation powder,<br />

hard capsule<br />

20 mg Rhône-Poulenc Rorer Fisons<br />

Ltd.<br />

6239 Intal Acidum cromoglicicum Nebuliser solution 10 mg/ml Rhône-Poulenc Rorer Fisons<br />

Ltd.<br />

6238 Intal Acidum cromoglicicum Pressurised inhalation,<br />

suspension<br />

5 mg/dawke˛ Rhône-Poulenc Rorer Fisons<br />

Ltd.<br />

29/11/06<br />

29/11/06<br />

29/11/06<br />

21/03/06<br />

29/11/06<br />

29/11/06<br />

21/03/06<br />

31/03/04<br />

31/03/04<br />

29/11/06<br />

29/11/06<br />

29/11/06<br />

21/03/06<br />

30/06/04<br />

30/01/05<br />

30/01/05<br />

6241 Inteflos Herbal tea Herbaflos, Płońsk 31/12/08<br />

6242 Integral Film-coated tablets Merck KGaA 30/06/05<br />

6243 Integrilin Solution for<br />

intravenous infusion<br />

6244 Integrilin Solution for<br />

intravenous injection<br />

6245 Intelektan,ginkofar® e/p Ginseng radix extractum<br />

siccum, Ginko bilobae<br />

folium extractum siccum<br />

Film-coated tablets 100 mg +<br />

60 mg<br />

6246 Intertocine-S Oxytocinum Solution for veterinary<br />

use<br />

6247 Intractum Crataegi Crataegi inflorescentiae<br />

intractum<br />

0.75 mg/ml Schering-Plough Europe<br />

Bruksela<br />

2 mg/ml Schering-Plough Europe<br />

Bruksela<br />

25/01/06<br />

25/01/06<br />

P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

Intervet 31/12/08<br />

Oral solution Phytopharm Kle˛ka S.A. 30/11/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1029<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6248 Intractum Hippocastani Hippocastani semen<br />

intractum<br />

Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

6249 Intractum Hyperici Hyperici herba intractum Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

6250 Intractum Melissae Melissae herba intractum Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

6251 Intractum Valerianae Valerianae radix<br />

intractum<br />

Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

6252 Intractum Visci Visci herba intractum Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

6253 Intraglobin F Immunoglobulinum<br />

humanum<br />

Solution for<br />

intravenous infusion<br />

50 mg/ml Biotest Pharma GmbH 30/04/04<br />

6254 Intralgis Ibuprofenum Gel 5 % Laboratoires ‘URGO’S.A 31/12/08<br />

6255 Intralipid 10 % Emulsja tłuszczowa do<br />

odzywiania<br />

pozajelitowego<br />

6256 Intralipid 20 % Emulsja tłuszczowa do<br />

odzywiania<br />

pozajelitowego<br />

6257 Intralipid 30 % Emulsja tłuszczowa do<br />

odzywiania<br />

pozajelitowego<br />

Emulsion for<br />

intravenous infusion<br />

Emulsion for<br />

intravenous infusion<br />

Emulsion for<br />

intravenous infusion<br />

6258 Intravit B12 Cyanocobalaminum Solution for veterinary<br />

use<br />

6259 Intron A Interferonum alfa-2b Liophylisate for<br />

solution for<br />

subcutaneous,<br />

intramuscular<br />

injection,for use on<br />

sick changes and for<br />

intravenous infusion<br />

6260 Intron A Interferonum alfa-2b Liophylisate for<br />

solution for<br />

subcutaneous,<br />

intramuscular<br />

injection,for use on<br />

sick changes and for<br />

intravenous infusion<br />

6261 Intron A Interferonum alfa-2b Liophylisate for<br />

solution for<br />

subcutaneous,<br />

intramuscular<br />

injection,for use on<br />

sick changes and for<br />

intravenous infusion<br />

6264 Intron A bez albumin Interferonum alfa-2b Solution for<br />

subcutaneous and<br />

intramuscular<br />

injection<br />

6265 Intron A bez albumin Interferonum alfa-2b Solution for<br />

subcutaneous and<br />

intramuscular<br />

injection<br />

6266 Intron A bez albumin Interferonum alfa-2b Solution for<br />

subcutaneous and<br />

intramuscular<br />

injection<br />

6262 Intron A bez albumin Interferonum alfa-2b Solution for<br />

subcutanous injection<br />

Fresenius Kabi AB Uppsala 31/03/07<br />

Fresenius Kabi AB Uppsala 31/07/04<br />

Fresenius Kabi AB Uppsala 31/03/07<br />

Norbrook 4/05/04<br />

10 mln. j.m. Schering-Plough Irland 31/07/04<br />

3 mln. j.m. Schering-Plough Irland 31/07/04<br />

5 mln. j.m. Schering-Plough Irland 31/07/04<br />

10 mln j.m./ml Schering-Plough Labo N.V. 23/03/05<br />

25 mln j.m./ml Schering-Plough Labo N.V. 23/03/05<br />

6 mln j.m./ml Schering-Plough Labo N.V. 23/03/05<br />

15 mln j.m./ml Schering-Plough Labo N.V. 23/03/05


EN<br />

1030 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6263 Intron A bez albumin Interferonum alfa-2b Solution for<br />

subcutanous injection<br />

6267 Invanz Ertapenemum Powder for<br />

concentrate for<br />

solution for<br />

intravenous infusion<br />

50 mln j.m./ml Schering-Plough Labo N.V. 23/03/05<br />

1 g (100 mg/<br />

ml)<br />

Merck Sharp & Dohme Idea<br />

Inc.<br />

6268 Invirase Saquinavirum Capsules 200 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

6269 Invivac 2000/2001 Vaccinum influenzae Suspension for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

6270 Iodium TX jod Liquid for veterinary<br />

use<br />

31/12/08<br />

31/12/07<br />

0,5 ml Solvay Pharmaceuticals B.V. 31/12/08<br />

Hypred 31/12/08<br />

6271 Iodum complexe Nr 118 Drops Lehning Laboratoires 24/03/07<br />

6272 Iogen Iohexolum Intravenous injection 240 mgI/ml,<br />

300 mgI/ml,<br />

350 mgI/ml<br />

6273 Iohexol Iohexolum Injection 240 mg/ml<br />

(50 ml)<br />

6274 Iohexol Iohexolum Injection 350 mg/ml<br />

(50 ml)<br />

6275 Iohexol Iohexolum Injection 300 mg/ml<br />

(50 ml)<br />

6276 Iohexol Iohexolum Injection 300 mg/ml<br />

(20 ml)<br />

6277 Iohexol Iohexolum Injection 240mg/ml<br />

(100 ml)<br />

6278 Iohexol Iohexolum Injection 350mg/ml<br />

(20 ml)<br />

6279 Iomeron 150 Iomeprolum Solution for injection 150 mg jodu/<br />

ml<br />

6280 Iomeron 200 Iomeprolum Solution for injection 200 mg jodu/<br />

ml<br />

6281 Iomeron 250 Iomeprolum Solution for injection 250 mg jodu/<br />

ml<br />

6282 Iomeron 300 Iomeprolum Solution for injection 300 mg jodu/<br />

ml<br />

6283 Iomeron 350 Iomeprolum Solution for injection 350 mg jodu/<br />

ml<br />

6284 Iomeron 400 Iomeprolum Solution for injection 400 mg jodu/<br />

ml<br />

GENEXO Sp.z.o.o Warszawa 31/12/08<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Bracco-Byk Gulden 31/12/08<br />

Bracco-Byk Gulden 31/12/08<br />

Bracco-Byk Gulden 31/12/08<br />

Bracco-Byk Gulden 31/12/08<br />

Bracco-Byk Gulden 31/12/08<br />

Bracco-Byk Gulden 31/12/08<br />

6285 Iopamiro 200 Iopamidolum Solution for injection 408 mg/ml Bracco Industria Chimica-Byk<br />

Gulden<br />

31/07/04<br />

6286 Iopamiro 300 Iopamidolum Solution for injection 612 mg/ml Bracco S.p.A. 31/07/04<br />

6287 Iopamiro 370 Iopamidolum Solution for injection 755 mg/ml Bracco S.p.A. 31/07/04<br />

6288 Iopidine Apraclonidinum Eye drops 0.5 % Alcon Laboratories Inc. 31/12/08<br />

6289 Ipeca Complexe Lehning nr 65 Drops Lehning Laboratoires 11/11/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1031<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6290 Ipeca compose krople Dolisos Laboratoires 31/12/08<br />

6291 Ipertrofan Mepartricinum Film-coated tablets 13 mg<br />

(50000 j.m.)<br />

6292 Ipertrofan 40 Mepartricinum Film-coated tablets 40 mg<br />

(150000 j.m.)<br />

Takeda Italia Farmaceutici<br />

S.p.A.<br />

SPA Societa Prodotti<br />

Antibiotici SpA<br />

6293 Iporel Clonidinum Tablets 0.075 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

6294 Ipowet — aerozol Bromfenwinfos Spray for veterinary<br />

use<br />

Zakłady Chemiczne<br />

Organika-Azot S.A.<br />

30/06/04<br />

31/12/08<br />

31/01/06<br />

10/02/04<br />

6295 Ipro Ibuprofenum Film-coated tablets 200 mg Schwarz Pharma Sp. z o.o. 31/12/08<br />

6296 IPV SzCZpionka<br />

Inaktywowana<br />

Solution for injection Wytwórnia Surowic i<br />

Szczepionek BIOMED<br />

31/12/08<br />

6297 Irenat Natrii perchloratum Oral drops, solution 300 mg/ml Bayer AG 30/04/05<br />

6298 Irgamid Sulfadicramidum Eye ointment 150 mg/g Novartis Ophthalmics AG<br />

Hettlingen<br />

6299 Irigem Methylis salicylas +<br />

Mentholum<br />

6300 Irinocetani Hydrochloridum Irinocetanum Concantrate for<br />

solution for<br />

intravenous infusion<br />

6301 Irinocetani Hydrochloridum Irinocetanum Concantrate for<br />

solution for<br />

intravenous infusion<br />

Ointment Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

6302 Irinotecam Irinotecanum Solution for injection 20 mg/ml,<br />

40 mg/ml,<br />

100 mg/ml<br />

20 mg / ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

40 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

28/08/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

6303 Irrodan Buflomedilum Tablets 300 mg Biomedica Foscama S.p.A. 31/12/08<br />

6304 IRRODAN Retard Buflomedilum Tablets 600 mg Biomedica Foscama S.p.A. 31/12/08<br />

6305 IRS-19 Antiinfectives,<br />

combinations<br />

Nasal spray, solution 60 dawek Solvay Pharma — Suresnes<br />

Cedex<br />

6306 Irtan 150 Irbesortanum Tablets 150 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

6307 Irtan 300 Irbesortanum Tablets 300 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

6308 Irtan 75 Irbesortanum Tablets 75 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

10/03/04<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

6309 Irubin Idarubicinum Capsules, hard 10 mg Instytut Farmaceutyczny 31/12/08<br />

6310 Irubin Idarubicinum Capsules, hard 25 mg Instytut Farmaceutyczny 31/12/08<br />

6311 Irubin Idarubicinum Capsules, hard 5 mg Instytut Farmaceutyczny 31/12/08<br />

6312 Irubin Idarubicinum Powder for solution<br />

for injection<br />

6313 Irubin Idarubicinum Powder for solution<br />

for injection<br />

10 mg Instytut Farmaceutyczny 31/12/08<br />

5 mg Instytut Farmaceutyczny 31/12/08<br />

6314 Iruxol Mono Collagenasum Ointment 1.2 j./g Abbott GmbH & Co KG 30/04/04<br />

6315 Irwan Liquid Irvan P.P.U. Sp. z o.o. 31/12/08<br />

6316 Iscador M amp. WELEDA 24/08/05


EN<br />

1032 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6317 Iscador P amp. WELEDA 24/08/05<br />

6318 Iscador Qu amp. WELEDA 24/08/05<br />

6319 Isicom 100 Levodopum +<br />

Carbidopum<br />

6320 Isicom 200 Levodopum +<br />

Carbidopum<br />

6321 Isiflu Zonale S.U. Influenza, purified<br />

antigen<br />

6322 Isla-Mint Lichenis islandici<br />

extractum<br />

6323 Isla-Moos Lichenis islandici<br />

extractum<br />

Tablets Desitin Arzneimittel GmbH 31/12/08<br />

Tablets Desitin Arzneimittel GmbH 31/12/08<br />

Suspension for<br />

intramuscular<br />

injection<br />

6324 Iso Mack Retard 20 Isosorbidi dinitras Prolonged release<br />

capsules<br />

6325 Iso Mack Retard 40 Isosorbidi dinitras Prolonged release<br />

capsules<br />

6326 Iso Mack Retard 60 Isosorbidi dinitras Prolonged release<br />

capsules<br />

6328 Isodinit Isosorbidi dinitras Prolonged release<br />

tablets<br />

Instituto Sierovaccinogeno<br />

Italiana — I.S.I. S.p.A.<br />

Lozenge 100 mg Engelhard Arzneimittel<br />

GmbH & Co KG<br />

Lozenge 80 mg Engelhard Arzneimittel<br />

GmbH & Co KG<br />

20 mg Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

40 mg Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

60 mg Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

30/11/04<br />

9/08/06<br />

9/08/06<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

20 mg Pharmachim-Holding AD 31/07/04<br />

6327 Isodinit Isosorbidi dinitras Tablets 10 mg Pharmachim-Holding AD 31/07/04<br />

6329 Isoket Isosorbidi dinitras Oromucosal spray 1.25 mg/dawke˛ Schwarz Pharma AG 31/05/04<br />

6330 Isoket Isosorbidi dinitras Solution for<br />

intravenous infusion<br />

1 mg/ml Schwarz Pharma AG 31/07/04<br />

6331 Isoket 5 Isosorbidi dinitras Tablets 5 mg Schwarz Pharma AG 31/05/04<br />

6332 Isoket Retard 20 Isosorbidi dinitras Prolonged release<br />

tablets<br />

6333 Isoket Retard 40 Isosorbidi dinitras Prolonged release<br />

tablets<br />

6334 Isoket Retard 120 Isosorbidi dinitras Prolonged release<br />

capsules<br />

20 mg Schwarz Pharma AG 31/07/04<br />

40 mg Schwarz Pharma AG 31/05/04<br />

120 mg Schwarz Pharma AG 31/05/04<br />

6335 Isoket Salbe Isosorbidi dinitras Ointment 100 mg/g Schwarz Pharma AG 30/04/05<br />

6336 Isomil Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

6337 Isomil 2 Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

Powder Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

Powder Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

6338 Isomil Df Liquid Ross Products Division,<br />

Abbott Laboratories, USA<br />

6339 Isomil RTF Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

Liquid Ross Products Division-<br />

Abbott Laboratories<br />

14/03/06<br />

24/08/05<br />

31/12/08<br />

11/10/06<br />

6340 Isomonit 20 Isosorbidi mononitras Tablets 20 mg Hexal AG 30/06/05<br />

6341 Isomonit 40 Isosorbidi mononitras Tablets 40 mg Hexal AG 30/06/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1033<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6342 ISOMONIT 60 Retard Isosorbidi mononitras Prolonged release<br />

tablets<br />

60 mg HEXAL AG 31/12/08<br />

6343 Isoniazidum Isoniazidum Tablets 300 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

6344 Isoniazidum Isoniazidum Tablets 50 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

15/11/06<br />

30/10/05<br />

6345 Isonit 40 Isosorbidi mononitras Tablets 40 mg Polfarmex S.A. 31/12/08<br />

6346 Isoprinosine Inosine pranobexum Tablets 0.5 g Ewopharma AG 31/07/04<br />

6347 Isoprivet methisoprinol Solution for veterinary<br />

use<br />

Vet-Agro 31/12/08<br />

6348 Isoptimil Verapamilum Tablets 40 mg Polfarmex S.A. 31/12/08<br />

6349 Isoptimil Verapamilum Tablets 80 mg Polfarmex S.A. 31/12/08<br />

6350 Isoptimil Verapamilum Tablets 120 mg Polfarmex S.A. 31/12/08<br />

6351 Isoptin Verapamilum Solution for injection 2.5 mg/ml Abbott GmbH & Co KG 31/05/04<br />

6352 Isoptin 40 Verapamilum Film-coated tablets 40 mg Abbott GmbH & Co KG 31/05/04<br />

6353 Isoptin 80 Verapamilum Film-coated tablets 80 mg Abbott GmbH & Co KG 31/05/04<br />

6354 Isoptin SR Verapamilum Prolonged release<br />

tablets<br />

6355 Isoptin SR-E 240 Verapamilum Prolonged release<br />

tablets<br />

120 mg Abbott GmbH & Co KG 30/04/04<br />

240 mg Abbott GmbH & Co KG 31/12/08<br />

6356 Isopto-Carbachol 1,5 % Carbacholum Eye drops, solution 15 mg/ml Alcon Couvreur N.V. 30/04/04<br />

6357 Isopto-Carbachol 3 % Carbacholum Eye drops, solution 30 mg/ml Alcon Couvreur N.V. 30/04/04<br />

6358 Isopto-Carpine 1 % Pilocarpinum Eye drops 10 mg/ml Alcon Couvreur N.V. 30/06/04<br />

6359 Isopto-Carpine 2 % Pilocarpinum Eye drops 20 mg/ml Alcon Couvreur N.V. 30/06/04<br />

6360 Isopto-Tears Hypromellosum Eye drops 5 mg/g Alcon Couvreur N.V. 30/06/04<br />

6361 Isoratio 20 Isosorbidi mononitras Tablets 20 mg ratiopharm GmbH 12/09/07<br />

6362 Isoratio 40 Isosorbidi mononitras Tablets 40 mg ratiopharm GmbH 12/09/07<br />

6363 Isoratio retard Isosorbidi mononitras Modified release<br />

capsules<br />

50 mg ratiopharm GmbH 12/09/07<br />

6364 Isotrex Isotretinoinum Gel 0.05 % Stiefel Laboratories Ltd. 31/12/08<br />

6365 Isotrexin Erythromycinum +<br />

Isotretinoinum<br />

Gel Stiefel Laboratories Ltd. 29/03/06<br />

6366 Isovist — 240 Iotrolanum Solution for injection 512.59 mg/ml Schering AG 30/04/04<br />

6367 Isovist 300 Iotrolanum Solution for injection 640.75 mg/ml Schering AG 30/04/04<br />

6368 Ispagul Plantaginis ovatae<br />

semins tegumentum<br />

Herb Herba Studio Ms´cisz i<br />

Wspólnicy Spółka Jawna<br />

9/08/06<br />

6369 Itraconazole Itraconazolum Capsules 100 mg POL-NIL Sp. z.o.o. 31/12/08<br />

6370 Itrax Itraconazolum Capsule 100 mg GENEXO Sp.z.o.o Warszawa 31/12/08<br />

6371 Itrazol Itraconazolum Capsules 100 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/12/08


EN<br />

1034 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6372 Itroconazole Itroconazolum Capsules 100 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

6373 Ivelip Emulsja tłuszczowa do<br />

wlewów doz˙ylnych<br />

6374 Ivelip Emulsja tłuszczowa do<br />

wlewów doz˙ylnych<br />

Fatty emulsion for<br />

intravenous infusion<br />

Fatty emulsion for<br />

intravenous infusion<br />

6375 Ivermectinum 1 % inj. iwermektyna Solution for veterinary<br />

use<br />

6376 Ivermectinum 1 % inj. Iwermektyna Solution for veterinary<br />

use<br />

6377 Ivermina 0,6 % premix iwermektyna Premix for veterinary<br />

use<br />

6378 Ivermina 1 % inj. Iwermektyna Solution for veterinary<br />

use<br />

6379 Ivomec inj. iwermektyna Solution for veterinary<br />

use<br />

6380 Ivomec Pour-On Iwermektyna Solution for veterinary<br />

use<br />

6381 Ivomec Premix Iwermektyna Premix for veterinary<br />

use<br />

6382 Iwermektyna 0,6 % premiks Iwermektyna Premix for veterinary<br />

use<br />

6383 Iwermektyna 1 % iniekcja Iwermektyna Solution for veterinary<br />

use<br />

6384 Iwermektyna pasta dla koni iwermektyna Paste for veterinary<br />

use<br />

10 % Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral Division<br />

20 % Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral Division<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Biowet Puławy 31/12/08<br />

Biowet Puławy 31/12/08<br />

Biowet Drwalew 31/12/08<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego S.A.<br />

15/01/06<br />

Merial 31/12/08<br />

Merial 7/07/05<br />

Merial 7/07/05<br />

Vetos-Farma 10/02/04<br />

Vetos-Farma 10/02/04<br />

Vetos-Farma 31/12/08<br />

6385 Iwostin HC Hydrocortisonum Cream 5 mg/g Nepentes Sp. Z o.o. 5/07/06<br />

6386 Ixel 25 Milnacipranum Capsules 25 mg Pierre Fabre Medicament 31/07/05<br />

6387 Ixel 50 Milnacipranum Capsules 50 mg Pierre Fabre Medicament 31/07/05<br />

6388 Izonit 10 Isosorbidi mononitras Tablets 10 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

6389 Izonit 20 Isosorbidi mononitras Tablets 20 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

6390 Izonit Prolongatrum 60 Isosorbidi mononitras Tablets 60 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

6391 Izonit prolongatum 40 Isosorbidi mononitras Prolonged release<br />

tablets<br />

40 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

6/06/07<br />

6/06/07<br />

31/12/08<br />

31/12/08<br />

6392 Izotek Isotretinoinum Capsules, soft 10 mg Blau — Farma Sp. z o.o. 31/12/08<br />

6393 Izotek Isotretinoinum Capsules, soft 20 mg Blau — Farma Sp. z o.o. 31/12/08<br />

6394 Izotertin Isotretinoinum Capsules, soft 10 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

6395 Izotertin Isotretinoinum Capsules, soft 20 mg HEXAL Polska Sp. z o.o. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1035<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6396 Izotren Isotretinoinum Gel 0,5 mg/g ZIAJA Ltd. Zakład<br />

Produkcyjny Gdańsk<br />

6397 Jacutin Lindanum Cutaneous emulsion 3 mg/g Boots Healthcare<br />

International<br />

6398 Jacutin Lindanum Gel 3 mg/g Boots Healthcare<br />

International<br />

6399 Japanisches Heilpflanzenöl<br />

Knufinke<br />

6400 Japonisches heipflanzen-ol ihprodler<br />

Inhalation vapour,<br />

solution<br />

Divapharma-Knufinke<br />

Arzneimittelwerk GmbH<br />

31/12/08<br />

12/07/05<br />

12/07/05<br />

30/04/04<br />

Woelm Pharma 31/12/08<br />

6401 Jatrosom N Tranylcyprominum Film-coated tablets 10 mg Esparma GmbH 31/12/08<br />

6402 Jeanine Ethinylestradiolum +<br />

Dienogestum<br />

6403 Jenetten Desogestrelum +<br />

Ethinylestradiolum<br />

Film-coated tablets 0,03 mg +<br />

2mg<br />

Schering AG 31/12/08<br />

Film-coated tablets Jenapharm GmbH & Co. 30/11/04<br />

6404 Jevity Preparat odz˙ywczy Liquid Ross Products Division-<br />

Abbott Laboratories<br />

30/06/05<br />

6405 Jod Iodum A.C.E.F., Włochy 31/12/08<br />

6406 Jod Iodum BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08<br />

6407 Jod Iodum Pharma Cosmetic, Kraków 31/12/08<br />

6408 Jod Iodum Pharma Zentrale 31/12/08<br />

6409 Jod Iodum Przedsie˛biorstwo Chmiczne<br />

Odczynniki Sp. z o.o., Lublin<br />

6410 Jodek potasu PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

6411 Jodek sodu Na 131 Ido<br />

wstrzykiwań<br />

6412 Jodek sodu, Na 131 I płyn<br />

doustny<br />

6413 Jodek sodu, Na 131 Iw<br />

kapsułkach<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Solution for injection Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Oral solution Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Capsules Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

6414 Joderm PVP — Jodine Spray 500 mg/g Zakłady Farmaceutyczno —<br />

Aerozolowe ‘UNIA’<br />

Spółdzielnia Pracy<br />

6415 Jodi Gel Polividonum iodinum Gel 1 g/0,1 g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

31/12/08<br />

19/10/05<br />

30/01/05<br />

31/01/06<br />

30/01/05<br />

31/12/08<br />

31/12/08<br />

6416 Jodid 100 Kalii iodidum Tablets 100 mcg J Merck KGaA 30/04/04<br />

6417 Jodid 200 Kalii iodidum Tablets 200 mcg J Merck KGaA 30/04/04<br />

6418 Jodofoam Kalii iodum + Iodum Spray for veterinary<br />

use<br />

Duna-Coop Sp. z o.o. 8/11/05<br />

6419 Jodoform Iodoformium A.C.E.F., Włochy 31/12/08<br />

6420 Jodoform Iodoformium Chema Elektromet, Rzeszów 31/12/08<br />

6421 Jodoform Iodoformium El Virus, Siemianowice 31/12/08<br />

6422 Jodoform Iodoformium Pharma Cosmetic, Kraków 31/12/08


EN<br />

1036 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6423 Jodoform Iodoformium Pharma Zentrale 31/12/08<br />

6424 Jodoform Iodoformium PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

6425 Jodostin Kalii iodidum Film-coated tablets 100 mcg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

6426 Jodox Kalii iodidum Tablets 200 mcg J Berlin-Chemie AG (Menarini<br />

Group)<br />

6427 Jodox 100 Kalii iodidum Tablets 100 µg BERLIN — CHEMIE AG<br />

(Menarini Group)<br />

6428 Jodthyrox Kalii iodidum +<br />

Levothyroxinum<br />

natricum<br />

4/03/07<br />

21/08/05<br />

31/12/07<br />

31/12/08<br />

Tablets Merck KGaA 15/12/05<br />

6429 Jodyna Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/01/06<br />

6430 Jodyna Hasco-Lek, Wrocław 31/01/06<br />

6431 Jodyna 3 % Kalii iodum + Iodum Solution for veterinary<br />

use<br />

6432 JONOSTERIL BASIC Z<br />

Glukoza˛<br />

Galvet 31/12/08<br />

Preparat złoz˙ony Solution for infusion Fresenius Kabi Deutschland<br />

GmbH<br />

31/12/08<br />

6433 JuBronchan C Jukunda Naturarzneimittel 31/12/08<br />

6434 Jucardon Liquid Jukunda Naturarzneimittel 31/12/08<br />

6435 Jucolon Mesalazinum Film-coated,<br />

gastro-resistant tablets<br />

250 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/03/07<br />

6436 JuCor Jukunda Naturarzneimittel 31/12/08<br />

6437 JuCystan S Jukunda Naturarzneimittel 31/12/08<br />

6438 JuGrippan S Jukunda Naturarzneimittel 31/12/08<br />

6439 JuHepan Jukunda Naturarzneimittel 31/12/08<br />

6440 JuMenstran Jukunda Naturarzneimittel 31/12/08<br />

6441 Jumex Selegilinum Tablets 5 mg Chinoin Pharmaceutical and<br />

Chemical Works Co. Ltd.<br />

30/06/04<br />

6442 Juniperus Complexe Nr 6 Drops Lehning Laboratoires 31/12/08<br />

6443 Juniperus/Berberis comp. Capsules WALA-Heilmittel GmbH 24/05/07<br />

6444 Jusedan Capsules Jukunda Naturarzneimittel 31/12/08<br />

6445 Jusedan Liquid Jukunda Naturarzneimittel 31/12/08<br />

6446 Jutussan Syrup Jukunda Naturarzneimittel 31/12/08<br />

6447 Juventin fix Herbal tea Herbapol Lublin S.A. 31/12/07<br />

6448 Juvit Acidum ascorbicum Drops 100 mg/ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

6449 Juvit D3 Colecalciferolum Oral drops 20 000 j.m./ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

6450 Juvit Multi Preparat złoz˙ony Oral drops, solution Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/03/06<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1037<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6451 Juvitan Liquid Jukunda Naturarzneimittel 31/12/08<br />

6452 Kabikinase Streptokinasum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

6453 Kabiven Preparat odz˙ywczy Kit: 2 solutions and<br />

emulsion for infusion<br />

6454 Kabiven Peripheral Preparat odz˙ywczy Kit: 2 solutions and<br />

emulsion for infusion<br />

6455 KADE FUNGIN 3<br />

COMBINATION Pack<br />

6456 KADE FUNGIN 3<br />

COMBINATION Pack<br />

Clotrimazolum Vagnial tablets,<br />

ointment<br />

Clotrimazolum Vagnial tablets,<br />

ointment<br />

6457 Kafaspirin Acidum acetylsalicylicum<br />

+ Coffeinum<br />

Tablets 500mg +<br />

50mg<br />

1500000 j.m. Pharmacia A.B. 30/04/04<br />

Fresenius Kabi AB Uppsala 11/10/06<br />

Fresenius Kabi AB Uppsala 17/01/07<br />

200 mg Dr Kade Pharmaceutical<br />

Fabrik<br />

100 mg Dr Kade Pharmaceutical<br />

Fabrik<br />

31/12/08<br />

31/12/08<br />

Bayer AG 29/10/06<br />

6458 Kalcyfediol Calcifediolum Capsules, soft 20 mcg Instytut Farmaceutyczny 12/10/05<br />

6459 Kalcyfediol Calcifediolum Capsules, soft 50 mcg Instytut Farmaceutyczny 12/10/05<br />

6460 Kalcytriol Calcitriolum Capsules, soft 0.25 mcg Instytut Farmaceutyczny 12/10/05<br />

6461 Kalcytriol Calcitriolum Capsules, soft 0.5 mcg Instytut Farmaceutyczny 12/10/05<br />

6462 Kaldyum Kalii chloridum Prolonged release<br />

capsules<br />

315 mg K+ Egis Pharmaceuticals Ltd. 31/08/05<br />

6463 Kalenduliss Preparat ziołowy Ointment 4 mg/g Naturwaren OHG Dr Peter<br />

Theiss<br />

6464 Kaletra Lopinavirum +<br />

Ritonavirum<br />

6465 Kaletra Lopinavirum +<br />

Ritonavirum<br />

6466 Kalimat prolongatum Kalii chloridum Prolonged release<br />

tablets<br />

6467 Kalipoz prolongatum Kalii chloridum Prolonged release<br />

tablets<br />

6468 Kalium Kalii chloridum Syrup 391 mg K +/<br />

5ml<br />

6469 Kalium Kalii chloridum Syrup 782 mg K+/<br />

10ml<br />

6470 Kalium chloratum 15 % Kalii chloridum Concentrate for<br />

solution for infusion<br />

6471 Kalium Chloratum<br />

Prolongatum<br />

6472 Kalium effervescens Kalii chloridum + Kalii<br />

hydrogencarbonas<br />

6473 Kalium effervescens<br />

(bezcukrowy)<br />

31/05/04<br />

Capsules, soft Abbott Laboratories Ltd. 16/05/07<br />

Oral solution Abbott Laboratories Ltd. 16/05/07<br />

393 mg K+ ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

391 mg K+ GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

27/06/06<br />

31/01/06<br />

31/12/05<br />

Polfarmex S.A 31/12/05<br />

150 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Kalii chloridum Tablets 750 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

Kalii citras + Kalii<br />

hydrogencarbonas<br />

Effervescent granules 782 mg K+/5g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Effervescent granules 782 mg K+/3g Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

31/01/06<br />

31/12/08<br />

31/12/05<br />

31/01/06<br />

6474 Kalium gluconicum Kalii gluconas Powder 390 mg K+/5g Polfarmex S.A 30/06/06<br />

6475 Kalium gluconicum Kalii gluconas Syrup 260 mg K +/<br />

5ml<br />

Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

31/12/05


EN<br />

1038 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6476 Kalium gluconicum Kalii gluconas Syrup 312 mg/ml Polfarmex S.A 31/12/05<br />

6477 Kalium guajacolosulfonicum Guaiacolsulfonatum Tablets 500 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

6478 Kalium hypermanganicum Kali permanganas Tablets 0.1 g Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

6479 Kalium iodatum Complexe<br />

Nr 84<br />

31/12/05<br />

31/12/04<br />

Drops Lehning Laboratoires 31/12/08<br />

6480 Kalmia compositum Amp. Heel GmbH 31/12/07<br />

6481 Kalmia compositum Drops Heel GmbH 31/12/07<br />

6482 Kalms Lupuli strobulus pulv. +<br />

Gentianae radix<br />

extractum siccum +<br />

Valerianae radix<br />

extractum siccum<br />

Tablets 45mg +<br />

22,5mg +<br />

33,75mg<br />

G.R. Lane Health Products<br />

Ltd.<br />

30/04/04<br />

6483 Kamagel Gel Krka d.d., Novo mesto 31/08/05<br />

6484 Kamfenol Chema-Elektromet, Rzeszów 31/12/08<br />

6485 Kamfora A.C.E.F, Włochy 31/12/08<br />

6486 Kamfora BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08<br />

6487 Kamfora Farm-Impex s.j., Gliwice 31/12/08<br />

6488 Kamfora Pharma Cosmetic, Kraków 31/12/08<br />

6489 Kamfora Pharma Zentrale 31/12/08<br />

6490 Kamfora PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

6491 Kamillen-Heel S Ointment Heel GmbH 30/09/05<br />

6492 Kamiren Doxazosinum Tablets 1 mg Krka d.d., Novo mesto 31/05/05<br />

6493 Kamiren Doxazosinum Tablets 2 mg Krka d.d., Novo mesto 31/05/05<br />

6494 Kamiren Doxazosinum Tablets 4 mg Krka d.d., Novo mesto 31/05/05<br />

6495 Kamiren Doxazosinum Tablets 1 mg KRKA Polska Sp. z o.o. 31/12/08<br />

6496 Kamiren Doxazosinum Tablets 2 mg KRKA Polska Sp. z o.o. 31/12/08<br />

6497 Kamiren Doxazosinum Tablets 4 mg KRKA Polska Sp. z o.o. 31/12/08<br />

6498 Kamistad Gel Lidocainum Gel Stada Arzneimittel AG 31/12/08<br />

6500 Kan jang Film-coated tablets Svenska Örtmedicinska<br />

Institutet AB, Szwecja<br />

6499 Kan jang Syrup Svenska Örtmedicinska<br />

Institutet AB, Szwecja<br />

6501 Kanamycyna 25 % inj. Siarczan kanamycyny Liquid for veterinary<br />

use<br />

6502 Kanavet 25 % Kanamycyny siarczan Solution for veterinary<br />

use<br />

6503 Kandesartan Candesartanum Tablets 2 mg<br />

kandesartanu<br />

cileksetylu<br />

31/12/08<br />

31/12/08<br />

Biowet Drwalew 31/12/08<br />

Alfasan International B.V. 27/01/07<br />

POLFA KUTNO S.A. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1039<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6504 Kandesartan Candesartanum Tablets 4 mg<br />

kandesartanu<br />

cileksetylu<br />

6505 Kandesartan Candesartanum Tablets 8 mg<br />

kandesartanu<br />

cileksetylu<br />

6506 Kandesartan Candesartanum Tablets 16 mg<br />

kandesartanu<br />

cileksetylu<br />

6507 Kaomycin Neomycyny siarczan,<br />

Kaolin, Pektyna<br />

Suspension for veterinary<br />

use<br />

POLFA KUTNO S.A. 31/12/08<br />

POLFA KUTNO S.A. 31/12/08<br />

POLFA KUTNO S.A. 31/12/08<br />

Pharmacia N.V./S.A. 4/05/04<br />

6508 Kaopectate Attalpulgitum Tablets 0.75 g Pharmacia & Upjohn Co. 30/04/04<br />

6509 Kapanol Morphinum Prolonged release<br />

capsules<br />

6510 Kapanol Morphinum Prolonged release<br />

capsules<br />

6511 Kapanol Morphinum Prolonged release<br />

capsules<br />

6512 Kaprogest Hydroxyprogesteroni<br />

caproas<br />

100 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

20 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

50 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Solution for injection 125 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/11/05<br />

6513 Kapsiplast Pach Viscoplast S.A. 31/01/06<br />

6514 Kapsiven Preparat złoz˙ony Ointment Zakład Chemiczno-<br />

Farmaceutyczny ‘FARMAPOL’<br />

Sp. z o.o., Poznań<br />

31/12/08<br />

6515 Kapsułki celulozowe HPMC Capsugel NV 19/12/06<br />

6516 Kapsułki nasenne Valerianae extractum<br />

siccum + Humuli<br />

extractum siccum<br />

Capsules, soft 200 mg +<br />

35 mg<br />

GlaxoSmithKline<br />

Pharmaceuticals Spółka<br />

Akcyjna<br />

31/12/08<br />

6517 Kapsułki skrobiowe Pelikan, Z˙yrardów 30/09/05<br />

6518 Kapsułki skrobiowe Spółdzielnia Pracy Usług<br />

Wielobranz˙owych, Z˙yrardów<br />

30/09/05<br />

6519 Kapsułki z˙elatynowe Associated Capsules Limited 24/01/06<br />

6520 Kapsułki z˙elatynowe Capsugel NV 24/01/06<br />

6521 Kapsułki z˙elatynowe Gelcap, Rumunia 24/01/06<br />

6522 Kapsułki z˙elatynowe Scherer 24/01/06<br />

6523 Kaptopril Denk Captoprilum Tablets 12,5 mg E. Denk OHG 31/12/08<br />

6524 Kaptopril Denk Captoprilum Tablets 25 mg E. Denk OHG 31/12/08<br />

6525 Kaptopril Denk Nifedipinum Tablets 50 mg E. Denk OHG 31/12/08<br />

6526 Karex — Wolff 325 Erythromycinum Tablets 325 mg Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

6527 Karex — Wolff 650 Erythromycinum Tablets 650 mg Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

6528 Karsivan Propentofilina Tablet for veterinary<br />

use<br />

6530 Karvol Preparat złoz˙ony Capsules for<br />

inhalation<br />

31/12/08<br />

31/12/08<br />

Intervet GesmbH 20/12/06<br />

Boots Healthcare<br />

International<br />

31/12/08


EN<br />

1040 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6529 Karvol Preparat złoz˙ony Inhalation drops Boots Healthcare<br />

International<br />

6531 Katadolon Flupirbinum Capsules 100 mg AWDpharma GmbH & Co.<br />

KG<br />

6532 Katadolon Dual Flupirtinum Prolonged release<br />

capsules<br />

400mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

6533 Katar Homeoporady Granules Laboratoires BOIRON 27/09/07<br />

6534 Katareksal Loratadinum +<br />

Pseudoephedrinum<br />

6535 Katareksal Loratidinum +<br />

Pseudoephedrinum<br />

Prolonged release<br />

tablets<br />

Prolonged release<br />

tablets<br />

5mg<br />

loratydyny,<br />

120 mg<br />

siarczanu<br />

pseudoefedryny<br />

Farmaceutyczno-Chemiczna<br />

Spółdzielnia Pracy GALENUS<br />

5mg + 120 mg Farmaceutyczno-Chemiczna<br />

Spółdzielnia Pracy GALENUS<br />

31/12/08<br />

31/12/08<br />

6536 Katen Mexiletinum Capsules 100 mg Slovakofarma a.s. 30/06/04<br />

6537 Kavakaps Piperis methystici<br />

rhizomae extractum<br />

siccum<br />

6538 Kavasedon Piperis methystici<br />

rhizomae extractum<br />

siccum<br />

Capsules, hard 160 mg Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Capsuels, hard 50 mg<br />

kawa-pironów<br />

Harras Pharma Curarina<br />

Arzneimittel GmbH<br />

6539 Kedrovit Oral solution Interregional Center<br />

‘Adaptogen’<br />

31/12/08<br />

26/04/06<br />

31/12/08<br />

6541 Keflex Cefalexinum Capsules 0.25 g Eli Lilly Italia S.p.A. 30/04/04<br />

6542 Keflex Cefalexinum Capsules 0.5 g Eli Lilly Italia S.p.A. 30/04/04<br />

6540 Keflex Cefalexinum Granules for oral<br />

suspension<br />

6543 Kefloxin Cefadroxilum Tablets for oral<br />

suspension<br />

6544 Kefzol Cefazolinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

250 mg/5ml Eli Lilly Italia S.p.A. 30/04/04<br />

1 g Ranbaxy Laboratoires Ltd. 31/12/08<br />

1 g Eli Lilly Italia S.p.A. 30/04/04<br />

6545 Kelicardina Oral solution Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

30/10/05<br />

6546 Kelp Tablets 500 mg Power Health Prod. 31/12/08<br />

6547 Kenalog 40 Triamcinolonum Suspension for<br />

injection<br />

40 mg/ml Krka d.d., Novo mesto 31/07/04<br />

6548 Kephalodoron 0.1 % tabl. WELEDA 24/08/05<br />

6549 Kephalodoron 5 % tabl. WELEDA 24/08/05<br />

6550 Kephalodoron D12 WELEDA 24/08/05<br />

6551 Keppra Levetiracetamum Film-coated tablets 1000 mg UCB S.A. 9/08/06<br />

6552 Keppra Levetiracetamum Film-coated tablets 250 mg UCB S.A. 9/08/06<br />

6553 Keppra Levetiracetamum Film-coated tablets 500 mg UCB S.A. 9/08/06<br />

6554 Keratolit Acidum salicylicum +<br />

Urea<br />

6555 Keratolysin Acidum lacticum +<br />

Acidum salicylicum<br />

Ointment ICN Polfa Rzeszów S.A. 30/04/05<br />

Ointment R & C — Przedsie˛biorstwo<br />

Farmaceutyczne s.c.<br />

31/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1041<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6556 Kernosan Preparat ziołowy Oromucosal drops Kern AG/POLMED Christian<br />

Kotyrba<br />

30/06/05<br />

6557 Kervrans silica Tablets Ferrosan A/S 31/12/08<br />

6558 Kestine Ebastinum Film-coated tablets 10 mg Laboratioria Almirall<br />

Prodesfarma B.V.<br />

6559 Ketamidor 10 % Ketaminum Solution for veterinary<br />

use<br />

6560 Ketamina 10 % Ketaminum Solution for veterinary<br />

use<br />

31/12/08<br />

Richter Pharma AG 27/03/07<br />

Biowet Puławy 24/01/07<br />

6561 Ketanest 10 Ketaminum Solution for injection 10 mg/ml Parke Davis GmbH 31/07/04<br />

6562 Ketanest 50 Ketaminum Solution for injection 50 mg/ml Parke Davis GmbH 31/07/04<br />

6563 KetaRiem 100 chlorowodorek<br />

ketaminy<br />

Liquid for veterinary<br />

use<br />

Riemser 31/12/08<br />

6564 Ketek Telithromycinum Film-coated tablets 400 mg Aventis Pharma S.A. 7/03/07<br />

6565 Ketof Ketotifenum Capsules 1 mg Hexal AG 30/01/05<br />

6566 Ketof Ketotifenum Syrup 1 mg/5 ml Hexal AG 31/05/05<br />

6567 Ketofen 10 mg Ketoprofenum Tablet for veterinary<br />

use<br />

6568 Ketofen 10 % Ketoprofenum Solution for veterinary<br />

use<br />

6569 Ketofen 20 mg Ketoprofenum Tablet for veterinary<br />

use<br />

6570 Ketofen 5 mg Ketoprofenum Tablet for veterinary<br />

use<br />

6571 Ketokonazol Ketoconazolum Tablets 200 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Merial 24/07/07<br />

Merial SAS 25/03/07<br />

Merial 24/07/07<br />

Merial 24/07/07<br />

31/12/05<br />

6572 Ketokonazol Ketoconazolum Tablets 200 mg Polfarmex S.A. 31/12/08<br />

6573 Ketokonazole Ketoconazolum Tablets 200 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/08<br />

6575 Ketonal Ketoprofenum Capsuels, hard 50 mg Lek Pharmaceuticals d.d. 11/10/06<br />

6576 Ketonal Ketoprofenum Cream 50 mg/g Lek Pharmaceuticals d.d. 13/03/06<br />

6577 Ketonal Ketoprofenum Solution for injection 50 mg/ml Lek Pharmaceuticals d.d. 13/03/06<br />

6574 Ketonal Ketoprofenum Suppository 100 mg Lek d.d. 31/12/08<br />

6578 Ketonal forte Ketoprofenum Film-coated tablets 100 mg Lek Pharmaceuticals d.d. 13/03/06<br />

6580 Ketoprofen Ketoprofenum Film-coated tablets 25 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

6581 Ketoprofen Ketoprofenum Film-coated tablets 50 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

6582 Ketoprofen Ketoprofenum Gel 25 mg / g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

6583 Ketoprofen Ketoprofenum Gel 25 mg/g Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

29/06/05


EN<br />

1042 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6579 Ketoprofen Ketoprofenum Suppository 100 mg Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

6584 Ketoprofen 1 % inj. Ketoprofenum Solution for veterinary<br />

use<br />

6585 Ketoprofen 2 % — Mas´ć Ketoprofenum Ointment for veterinary<br />

use<br />

29/06/05<br />

Biowet Drwalew 31/12/08<br />

Biowet Drwalew 31/12/08<br />

6588 Ketores Ketoprofenum Gel 2.5 % ICN Polfa Rzeszów S.A. 14/12/05<br />

6586 Ketores Ketoprofenum Prolonged release<br />

capsules<br />

6587 Ketores Ketoprofenum Prolonged release<br />

capsules<br />

100 mg ICN Polfa Rzeszów S.A. 31/05/05<br />

200 mg ICN Polfa Rzeszów S.A. 31/05/05<br />

6589 Ketosteril Film-coated tablets Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

31/01/05<br />

6590 Ketotifen Ketotifenum Syrup 0,2 mg /ml Aflofarm 31/12/08<br />

6591 Ketotifen Ketotifenum Syrup 1 mg/5ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

6592 Ketotifen Ketotifenum Syrup 1 mg/5ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

6593 Ketotifen Ketotifenum Tablets 1 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

6594 Kiddi Fizz Prep. Witaminowy z<br />

minerałami<br />

6595 Kidrolase Asparaginasum Lyophilisate for<br />

solution for injection<br />

6596 Kiltix dla duz˙ych psów Propoksur, Flumetryna Collar for veterinary<br />

use<br />

6597 Kiltix dla małych psów propoksur, flumetryna Collar for veterinary<br />

use<br />

30/11/05<br />

30/06/06<br />

30/11/05<br />

Effervescent tablets Pharmaton S.A. 31/10/05<br />

10000 j.m. Rhône-Poulenc Rorer Bellon 30/01/05<br />

Bayer 12/06/05<br />

Bayer 31/12/08<br />

6598 Kinder Biovital Oral solution Roche Consumer Health Ltd 31/05/04<br />

6599 Kinder Biovital Toffy Tablets Roche Consumer Health Ltd 31/05/04<br />

6600 Kinetex Dimenhydrinatum Buccal tablets 10 mg Przedsiebiorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego ‘CEFARM’<br />

31/12/08<br />

6601 Kinidin Durules Chinidinum Film-coated tablets 200 mg AstraZeneca AB 30/06/04<br />

6602 KKV — ROS — szczepionka<br />

przeciw poraz˙eniu dziecie˛cemu,<br />

doustna, typ 1, 2, 3<br />

6603 KKV — ROS — szczepionka<br />

przeciw poraz˙eniu dziecie˛cemu,<br />

doustna, typ 1, 2, 3<br />

6604 KKV — ROS — szczepionka<br />

przeciw poraz˙eniu dziecie˛cemu,<br />

doustna, typ 1, 2, 3<br />

Zawiesina atenuowanych<br />

szczepów wirusa polio<br />

typ 1,2,3<br />

Zawiesina atenuowanych<br />

szczepów wirusa polio<br />

typ 1,2,3<br />

Zawiesina atenuowanych<br />

szczepów wirusa polio<br />

typ 1,2,3<br />

Oral suspension Instytut Poliomyelitis i<br />

Wirusowego Zapalenia<br />

Mózgu Rosyjskiej Akademii<br />

Nauk Medycznych<br />

Oral suspension Instytut Poliomyelitis i<br />

Wirusowego Zapalenia<br />

Mózgu Rosyjskiej Akademii<br />

Nauk Medycznych<br />

Oral suspension Instytut Poliomyelitis i<br />

Wirusowego Zapalenia<br />

Mózgu Rosyjskiej Akademii<br />

Nauk Medycznych<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

6605 Klabion Clarithromycinum Film-coated tablets 250 mg Bioton Sp. z o.o. 5/07/06<br />

6606 Klabion Clarithromycinum Film-coated tablets 500 mg Bioton Sp. z o.o. 5/07/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1043<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6610 Klacid Clarithromycinum Film-coated tablets 250 mg Abbott S.p.A 31/01/05<br />

6611 Klacid Clarithromycinum Film-coated tablets 500 mg Abbott Laboratories Ltd. 30/06/07<br />

6607 Klacid Clarithromycinum Granules for oral<br />

suspension<br />

6608 Klacid Clarithromycinum Granules for oral<br />

suspension<br />

6609 Klacid Clarithromycinum Powder for solution<br />

for intravenous<br />

infusion<br />

6612 Klacid Uno Clarithromycinum Modified release<br />

tablets<br />

250 mg/5 ml Abbott S.p.A 31/12/08<br />

125 mg/5ml Abbott S.p.A 31/01/05<br />

500 mg Abbott France S.A. 22/11/05<br />

500 mg Abbott Laboratories Ltd. 31/12/08<br />

6613 Klaratio 250 Clarithromycinum Film-coated tablets 250 mg ratiopharm GmbH 31/12/08<br />

6614 Klaratio 500 Clarithromycinum Film-coated tablets 500 mg ratiopharm GmbH 31/12/08<br />

6615 Klarmin Clarithromycinum Film-coated tablets 250 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

6616 Klarmin Clarithromycinum Film-coated tablets 500 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

6617 Klato-Lan Tylozyna Powder for veterinary<br />

use<br />

6622 Klavocin Amoxicillinum +<br />

Acidum clavulanicum<br />

6623 Klavocin Amoxicillinum +<br />

Acidum clavulanicum<br />

6624 Klavocin Amoxicillinum +<br />

Acidum clavulanicum<br />

6620 Klavocin Amoxicillinum +<br />

Acidum clavulanicum<br />

6621 Klavocin Amoxicillinum +<br />

Acidum clavulanicum<br />

6618 Klavocin Amoxicillinum +<br />

Acidum clavulanicum<br />

6619 Klavocin Amoxicillinum +<br />

Acidum clavulanicum<br />

6625 KLAVOCIN Forte Amoxicillinum +<br />

Acidum clavulanicum<br />

Film-coated tablets 250 mg +<br />

125 mg<br />

Film-coated tablets 500 mg +<br />

125 mg<br />

Film-coated tablets 875 mg +<br />

125 mg<br />

Powder for oral<br />

suspension<br />

Powder for oral<br />

suspension<br />

Powder for solution<br />

for intravascular<br />

injection and infusion<br />

Powder for solution<br />

for intravascular<br />

injection and infusion<br />

Powder for oral<br />

suspension<br />

(125 mg +<br />

31,25 mg)/<br />

5ml<br />

(400 mg +<br />

57 mg)/5 ml<br />

500 mg +<br />

100 mg<br />

1000 mg +<br />

200 mg<br />

(250 mg +<br />

62,5 mg)/5 ml<br />

Klat-Chemie 31/12/08<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

6626 Klimacin Capsule, hard Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

6627 Klimadynon Film-coated tablets Bionorica AG 27/06/07<br />

6628 Klimafemin Cimicifugae racemosae<br />

rhizomae tinctura (1:10)<br />

Drops Herbapol — Lublin S.A. 31/12/08<br />

6629 Klimafemin Preparat złoz˙ony Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

6630 Klimakt-Heel Sublingual tablets Heel GmbH 30/06/07<br />

6631 Klimaktin Lek Pharmaceutical &<br />

Chemical Company d.d.<br />

6632 Klimaktobonisol Preparat złoz˙ony Oral solution Laboratorium Medycyny<br />

Naturalnej ‘Bonimed’<br />

31/12/08<br />

31/12/08


EN<br />

1044 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6633 Klimaktoplant Tablets DHU-Arzneimittel GmbH &<br />

Co.KG<br />

6634 Klimaren Estradiolum +<br />

Levonorgestelum<br />

Coated tablets preparat<br />

złoz˙ony<br />

6635 Klimaren Film-coated tablet preparat<br />

złoz˙ony<br />

6636 Klimasol Cimicifugae extractum<br />

siccum<br />

6637 Klimasol Cimicifugae radix<br />

extractum<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/08/05<br />

31/12/08<br />

31/12/08<br />

Capsule, hard Phytopharm Kle˛ka S.A. 31/12/08<br />

Oral drops Phytopharm Kle˛ka S.A. 14/12/05<br />

6638 Klimax Preparat złoz˙ony Oral solution Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

30/09/07<br />

6639 Klimicin Clindamycinum Capsules 150 mg Lek Pharmaceuticals d.d. 30/04/04<br />

6640 Klimicin Clindamycinum Capsules 300 mg Lek Pharmaceuticals d.d. 31/12/07<br />

6641 Klimicin Clindamycinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

6642 Klimicin Clindamycinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

6643 Klimodien Estradiolum +<br />

Dienogestum<br />

6644 Klimonorm Estradiolum +<br />

Levonorgestrelum<br />

150 mg/ml Lek Pharmaceuticals d.d. 30/04/04<br />

150 mg/ml Lek Pharmaceuticals d.d. 30/04/04<br />

Film-coated tablets 2 mg + 2 mg Schering AG 31/12/08<br />

Coated tablets Jenapharm GmbH & Co. 30/04/04<br />

6645 Klindacin T Clindamycinum Gel 10 mg/g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

6646 Klindamycin Clindamycinum Gel 10 mg/g Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych ‘EMO’<br />

6647 Kliogest Estradiolum +<br />

Norethisteronum<br />

6648 Klitix dla s´rednich psów Propoksur, Flumetryna Collar for veterinary<br />

use<br />

6/06/07<br />

31/12/08<br />

Film-coated tablets Novo Nordisk A/S 31/01/05<br />

Bayer 12/06/05<br />

6649 Klofenil Diclofenacum Gel 5 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

6650 Klopidogrel Clopidogrelum Film-coated tablets 75 mg Instytut Farmaceutyczny 31/12/08<br />

6651 Kloracef Cefaclorum Prolonged release<br />

tablets<br />

750 mg Bioton Sp. z o.o. 31/12/08<br />

6652 Klosterfrau Activ Kapseln Capsules M.C.M. Klosterfrau<br />

Vetriebsgesellschaft m.b.H<br />

6653 Klosterfrau beruhigungskapseln<br />

forte<br />

Capsules M.C.M. Klosterfrau Vertriebs<br />

GmbH<br />

6654 Klotrigem Clotrimazolum Cream 1 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

6655 Klozapol Clozapinum Tablets 100 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/04/04<br />

31/12/08<br />

31/12/08<br />

30/06/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1045<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6656 Klozapol Clozapinum Tablets 25 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

6657 Kła˛cze imbiru Herb in bags Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

6658 Kła˛cze imbiru Zioła Lecznicze Boguccy,<br />

Kraków<br />

31/12/05<br />

24/09/07<br />

24/09/07<br />

6659 Kła˛cze imbiru (Zingerek) Capsules 220 mg Herbapol Poznań 9/01/07<br />

6660 Kła˛cze imbiru kaps. 250 mg<br />

Avioplant Junior<br />

Phytopharm Kle˛ka S.A. 24/08/05<br />

6661 Kła˛cze imbiru kaps. 300 mg Phytopharm Kle˛ka S.A. 31/01/06<br />

6662 Kła˛cze imbiru LOKOMOTIV Capsules 300 mg Aflofarm Fabryka Leków,<br />

Ksawerów<br />

6663 Kła˛cze perzu Agropyri rhizoma A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

14/06/05<br />

19/07/07<br />

6664 Kła˛cze perzu Agropyri rhizoma Herbalux, Warszawa 19/07/07<br />

6665 Kła˛cze perzu Agropyri rhizoma Herbapol Lublin 19/07/07<br />

6666 Kła˛cze perzu Agropyri rhizoma Herbapol Pruszków 19/07/07<br />

6667 Kła˛cze perzu Agropyri rhizoma Zakład DARY NATURY,<br />

Grodzisk<br />

6668 Kła˛cze perzu Agropyri rhizoma Zakład DARY NATURY,<br />

Grodzisk<br />

6669 Kła˛cze perzu Agropyri rhizoma Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6670 Kła˛cze perzu Agropyri rhizoma Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

19/07/07<br />

19/07/07<br />

19/07/07<br />

19/07/07<br />

6671 Kła˛cze perzu 1 Agropyri rhizoma Herbapol Kraków 31/08/05<br />

6672 Kła˛cze perzu 1 Agropyri rhizoma Zioła Lecznicze Boguccy,<br />

Kraków<br />

31/08/05<br />

6673 Kła˛cze pie˛ciornika Herbalux, Warszawa 26/03/06<br />

6674 Kła˛cze pie˛ciornika Herbapol Lublin 26/03/06<br />

6675 Kła˛cze pie˛ciornika Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

6676 Kła˛cze pie˛ciornika Zioła Lecznicze Boguccy,<br />

Kraków<br />

6677 Kła˛cze pie˛ciornika 1 Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6678 Kła˛cze Pie˛ciornika - Rhizoma<br />

Tormentillae<br />

Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

26/03/06<br />

26/03/06<br />

31/12/05<br />

31/12/04<br />

6679 Kła˛cze tataraku Herbapol Lublin 31/12/07<br />

6680 Kła˛cze tataraku Zakład DARY NATURY,<br />

Grodzisk<br />

6681 Kła˛cze tataraku Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

31/12/07<br />

31/12/07


EN<br />

1046 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6682 Kła˛cze tataraku Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/12/07<br />

6683 Kła˛cze we˛z˙ownika Herbalux, Warszawa 14/05/07<br />

6684 Kła˛cze we˛z˙ownika Herbapol Białystok 14/05/07<br />

6685 Kła˛cze we˛z˙ownika Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

6686 Kła˛cze we˛z˙ownika Zioła Lecznicze Boguccy,<br />

Kraków<br />

6687 Kłopoty z zasypianiem<br />

HomeoPorady<br />

6688 Koate DVI Coagulation factor VIII Intravenous injection<br />

(lyophilisate)<br />

6689 Koate DVI Coagulation factor VIII Intravenous injection<br />

(lyophilisate)<br />

6690 Koate DVI Coagulation factor VIII Intravenous injection<br />

(lyophilisate)<br />

6691 Koate HP Coagulation factor VIII Intravenous injection<br />

(lyophilisate)<br />

6692 Koci pazur Uncariae tomentosae<br />

cortex pulv.<br />

14/05/07<br />

14/05/07<br />

Laboratoires BOIRON 30/06/07<br />

1000 j.m. Bayer Corporation 31/12/07<br />

250 j.m. Bayer Corporation 31/12/07<br />

500 j.m. Bayer Corporation 31/12/07<br />

1500 j.m. Bayer Corporation 31/12/07<br />

Capsules, hard 540 mg MMS International Nature's<br />

Way Products Inc., USA<br />

31/12/08<br />

6693 Kodeiny fosforan Pharma Cosmetic, Kraków 28/02/06<br />

6694 Kodeiny fosforan Polfa Kutno 28/02/06<br />

6695 Koenzym Q10 Ubidecarenonum Capsules, soft 30 mg Puritan's Pride Inc., USA 31/12/08<br />

6696 Koenzym Q10 Ubidecarenonum Tablets 30 mg Vitamex AB 31/07/04<br />

6697 Kofeina A.C.E.F, Włochy 31/12/08<br />

6698 Kofeina BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08<br />

6699 Kofeina Pharma Cosmetic, Kraków 31/12/08<br />

6700 Kofeina PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

6701 Kofeino-sodowy benzoesan Farm-Impex s.j., Gliwice 4/10/07<br />

6702 Kofeino-sodowy benzoesan Pharma Cosmetic, Kraków 4/10/07<br />

6703 Kofeino-sodowy benzoesan Pharma Zentrale 4/10/07<br />

6704 Kofeino-sodowy salicylan Pharma Zentrale 14/01/05<br />

6705 Koferina tabletki od bólu<br />

głowy<br />

Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Ethoxybenzamidum<br />

Tablets Laboratorium<br />

Farmaceutyczne mgr farm.<br />

Zofia Sadowska<br />

6706 Kofevit Preparat złoz˙ony Effervescent powder Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

6708 Kofex Coffeinum Buccal tablets 40 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

6707 Kofex Coffeinum Lozenge 40 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

12/06/07<br />

31/12/08<br />

30/01/05<br />

11/10/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1047<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6709 Koforan Sulfadimetoksyny sól<br />

sodowa,<br />

Dimetylopirymidyna,<br />

Witamina A,<br />

Witamina K3<br />

6710 Kogenate Bayer Czynnik krzepnie˛cia VIII<br />

rekombinowany<br />

6711 Kogenate Bayer Czynnik krzepnie˛cia VIII<br />

rekombinowany<br />

6712 Kogenate Bayer Czynnik krzepnie˛cia VIII<br />

rekombinowany<br />

Powder for veterinary<br />

use<br />

Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

injection<br />

Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

injection<br />

Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

injection<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

25/05/04<br />

250 j.m. Bayer AG 31/12/08<br />

500 j.m. Bayer AG 31/12/08<br />

1000 j.m. Bayer AG 31/12/08<br />

6713 Kokainy chlorowodorek Merck KGaA 30/06/06<br />

6714 Kokainy chlorowodorek Pharma Cosmetic, Kraków 30/06/06<br />

6715 Kokcisan 12 % granulat Salinomycyna Granules for veterinary<br />

use<br />

6716 Kokcisan 12 % granulat Salinomycyna Premix for veterinary<br />

use<br />

KRKA 31/12/08<br />

KRKA 31/12/08<br />

6717 Kolistyny siarczan Scholz, Sowin 19/08/05<br />

6718 Kolodium Collodium A.C.E.F., Włochy 31/12/08<br />

6719 Kolodium Collodium Caesar & Loretz GmbH Caelo 31/12/08<br />

6720 Kolodium Collodium Zakład Farmaceutyczny<br />

Amara, Kraków<br />

6721 Kolpotex-230 Nonoxinolum Pessary 230 mg Adamed Sp. z o.o.<br />

Laboratorium<br />

Farmaceutyczne<br />

M.Adamkiewicz<br />

6722 Kolpotex-Oval Nonoxinolum Pessary 75 mg Adamed Sp. z o.o.<br />

Laboratorium<br />

Farmaceutyczne<br />

M.Adamkiewicz<br />

6723 Kompensan Dihydroxyaluminii natrii<br />

carbonas<br />

6725 Kompensan S Dihydroxyaluminii natrii<br />

carbonas<br />

6724 Kompensan S Dihydroxyaluminii natrii<br />

carbonas<br />

Tablets 0.34 g Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

Suspension 3.4 mg/ml Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

Tablets 0.34 g Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

6726 Koncentrat Czynnika IX Injection 500 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

6727 Koncentrat Czynnika IX Injection 600 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

6728 Koncentrat Czynnika IX Lyophilisate and<br />

solvent for solution<br />

for injection and<br />

intravascular infusion<br />

250 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

31/12/08<br />

31/12/05<br />

31/12/05<br />

31/07/04<br />

31/07/04<br />

31/07/04<br />

30/10/05<br />

30/10/05<br />

30/10/05


EN<br />

1048 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6729 Koncentrat czynnika IX Lyophilisate and<br />

solvent for solution<br />

for injection and<br />

intravascular infusion<br />

6730 Koncentrat octanowy do<br />

dializy pozaustrojowej<br />

6731 Koncentrat we˛glanowy do<br />

dializy pozaustrojowej. Typ BL<br />

(A+B)<br />

6732 Koncentrat we˛glanowy do<br />

dializy pozaustrojowej. Typ F<br />

(A+B)<br />

6733 Koncentrat we˛glanowy do<br />

dializy pozaustrojowej. Typ G<br />

(A+B)<br />

6734 Konsulfatrim Sulphadiazinum +<br />

Trimethoprimum<br />

Concentrate for<br />

extracorporeal dialysis<br />

solution<br />

Concentrate for<br />

extracorporeal dialysis<br />

solution<br />

Concentrate for<br />

extracorporeal dialysis<br />

solution<br />

Concentrate for<br />

extracorporeal dialysis<br />

solution<br />

Powder for veterinary<br />

use<br />

6735 Konyne 80 Coagulation factor IX Intravenous injection<br />

(lyophilisate)<br />

6736 Kopiryna Acidum acetylsalicylicum<br />

+ Coffeinum<br />

400 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

30/10/05<br />

Karima 1/08/05<br />

Karima 1/08/05<br />

Karima 1/08/05<br />

Karima 1/08/05<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

31/12/07<br />

500 j.m. Bayer Corporation 31/12/08<br />

Tablets Laboratorium<br />

Farmaceutyczne mgr farm.<br />

Zofia Sadowska<br />

25/01/06<br />

6737 Kora de˛bowa Herbapol Lublin 30/11/05<br />

6738 Kora de˛bowa 1 i 2 Quercus Cortex Herbalux, Warszawa 10/04/06<br />

6739 Kora de˛bowa 1 i 2 Quercus Cortex Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

10/04/06<br />

6740 Kora de˛bu Quercus Cortex Celluloid capsules 375 g Phytopharm Kle˛ka S.A. 19/03/07<br />

6741 Kora de˛bu Quercus Cortex Gelatin capsules 375 g Phytopharm Kle˛ka S.A. 19/03/07<br />

6742 Kora de˛bu Quercus Cortex Herbapol Pruszków 19/03/07<br />

6743 Kora de˛bu Quercus Cortex Herbapol Wrocław 19/03/07<br />

6744 Kora de˛bu Quercus Cortex Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

6745 Kora de˛bu Quercus Cortex Capsules 350 mg Aflofarm Fabryka Leków,<br />

Ksawerów<br />

19/03/07<br />

29/10/05<br />

6746 Kora de˛bu 1 Quercus Cortex Herbapol Kraków 31/08/05<br />

6747 Kora de˛bu 1 Quercus Cortex Zioła Lecznicze Boguccy,<br />

Kraków<br />

6748 Kora de˛bu Kapsułki<br />

ENTEROPLANT<br />

31/08/05<br />

Quercus Cortex Phytopharm Kle˛ka S.A. 31/12/08<br />

6749 Kora kaliny Herbapol Białystok 13/05/06<br />

6750 Kora kaliny Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6751 Kora kaliny Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

13/05/06<br />

13/05/06<br />

6752 Kora kaliny koralowej 1 Herbalux, Warszawa 16/06/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1049<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6753 Kora Kasztanowca Hippocastani cortex Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

6754 Kora kasztanowca Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

6755 Kora Kasztanowca - Cortex<br />

Hippocastani<br />

Hippocastani cortex Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

27/09/06<br />

31/12/08<br />

31/12/04<br />

6756 Kora kruszyny Herbapol Pruszków 15/03/05<br />

6757 Kora kruszyny Herbapol Wrocław 15/03/05<br />

6758 Kora kruszyny Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

15/03/05<br />

6759 Kora kruszyny 1 Elanda, Rozprza 10/04/06<br />

6760 Kora kruszyny 1 Herbalux, Warszawa 10/04/06<br />

6761 Kora kruszyny 1 Herbapol Kraków 10/04/06<br />

6762 Kora kruszyny 1 Zioła Lecznicze Boguccy,<br />

Kraków<br />

6763 Kora kruszyny 1 i 2 Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6764 Kora kruszyny 1 i 2 (Frangulae<br />

fix, Kruszyna fix)<br />

10/04/06<br />

31/12/08<br />

Herbapol Lublin 31/12/07<br />

6765 Kora kruszyny Linea Capsules 200 mg Aflofarm Fabryka Leków,<br />

Ksawerów<br />

6766 Kora wierzby Salicis cortex A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

24/11/05<br />

19/07/07<br />

6767 Kora wierzby Salicis cortex Herbalux, Warszawa 19/07/07<br />

6768 Kora wierzby Salicis cortex Herbapol Kraków 19/07/07<br />

6769 Kora wierzby Herb Bogucki, Kraków 19/07/07<br />

6770 Kora Wierzby Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

19/07/07<br />

6771 Kora Wierzby Herb Herbapol Lublin S.A. 19/07/07<br />

6772 Kora Wierzby Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

19/07/07<br />

6773 Kornam Terazosinum Tablets 2 mg Lek Pharmaceuticals d.d. 30/04/05<br />

6774 Kornam Terazosinum Tablets 2 mg Lek Polska Sp. z o.o. 30/04/05<br />

6775 Kornam Terazosinum Tablets 5 mg Lek Pharmaceuticals d.d. 30/04/05<br />

6776 Kornam Terazosinum Tablets 5 mg Lek Polska Sp. z o.o. 30/04/05<br />

6777 Kortikol Mometasoni furoas Cream 1 mg/g Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych ‘EMO’<br />

6778 Kortygem Hydrocortisonum Ointment 1 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

31/12/08<br />

31/12/08<br />

6779 Korzeń arcydzie˛gla Herbalux, Warszawa 24/01/06<br />

6780 Korzeń arcydzie˛gla Herbapol Lublin 24/01/06


EN<br />

1050 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6781 Korzeń arcydzie˛gla Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6782 Korzeń arcydzie˛gla Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

24/01/06<br />

24/01/06<br />

6783 Korzeń arcydzie˛gla 1 Herbapol Kraków 31/03/05<br />

6784 Korzeń arcydzie˛gla 1 Zioła Lecznicze Boguccy,<br />

Kraków<br />

6785 Korzeń Cykorii Podróz˙nika Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

31/03/05<br />

30/10/05<br />

6786 Korzeń goryczki Herbapol Białystok 13/05/06<br />

6787 Korzeń goryczki Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6788 Korzeń goryczki Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

13/05/06<br />

13/05/06<br />

6789 Korzeń goryczki 1 Herbalux, Warszawa 24/06/06<br />

6790 Korzeń goryczki 1 Herbapol Kraków 24/06/06<br />

6791 Korzeń goryczki 1 Zioła Lecznicze Boguccy,<br />

Kraków<br />

24/06/06<br />

6792 Korzeń kozłka Herbalux, Warszawa 28/02/06<br />

6793 Korzeń kozłka Herbapol Lublin 28/02/06<br />

6794 Korzeń kozłka Zakład DARY NATURY,<br />

Grodzisk<br />

6795 Korzeń kozłka Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6796 Korzeń kozłka Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

28/02/06<br />

28/02/06<br />

28/02/06<br />

6797 Korzeń kozłka 1 Herbapol Kraków 31/08/05<br />

6798 Korzeń kozłka 1 Zioła Lecznicze Boguccy,<br />

Kraków<br />

6799 Korzeń lubczyka Levistici radix Herb A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

31/08/05<br />

19/07/07<br />

6800 Korzeń lubczyka Levistici radix Herbalux, Warszawa 19/07/07<br />

6801 Korzeń lubczyka Levistici radix Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6802 Korzeń lubczyka Levistici radix Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

6803 Korzeń lubczyka Levistici radix Zioła Lecznicze Boguccy,<br />

Kraków<br />

19/07/07<br />

19/07/07<br />

19/07/07<br />

6804 Korzeń lukrecji Herbapol Lublin 14/09/07<br />

6805 Korzeń lukrecji Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6806 Korzeń lukrecji Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14/09/07<br />

14/09/07<br />

6807 Korzeń lukrecji 1 Herbapol Kraków 31/03/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1051<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6808 Korzeń lukrecji 1 Zioła Lecznicze Boguccy,<br />

Kraków<br />

31/03/05<br />

6809 Korzeń lukrecji 1 i 2 Herbalux, Warszawa 26/03/06<br />

6810 Korzeń Łopianu Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/10/05<br />

6811 Korzeń Łopianu Herb Herbapol Lublin S.A. 30/10/05<br />

6812 Korzeń Łopianu Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

6813 Korzeń Łopianu Herb Zioła Lecznicze — Boguccy<br />

s.c.<br />

30/10/05<br />

30/10/05<br />

6814 Korzeń mniszka Herbapol Lublin 31/12/07<br />

6815 Korzeń mniszka Zakład DARY NATURY,<br />

Grodzisk<br />

6816 Korzeń mniszka Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6817 Korzeń mniszka Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

6818 Korzeń mniszka Zioła Lecznicze Boguccy,<br />

Kraków<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

6819 Korzeń mniszka 1 Elanda, Rozprza 31/08/05<br />

6820 Korzeń mniszka 1 Herbalux, Warszawa 31/08/05<br />

6821 Korzeń mydlnicy Herbalux, Warszawa 31/07/06<br />

6822 Korzeń mydlnicy Herbapol Lublin 31/07/06<br />

6823 Korzeń mydlnicy Herbapol Pruszków 31/07/06<br />

6824 Korzeń mydlnicy Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6825 Korzeń mydlnicy Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/07/06<br />

31/07/06<br />

6826 Korzeń omanu Herbapol Lublin 31/12/08<br />

6827 Korzeń omanu Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6828 Korzeń omanu Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/12/08<br />

31/12/08<br />

6829 Korzeń omanu 1 Herbalux, Warszawa 25/08/06<br />

6830 Korzeń pierwiosnki Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

31/07/05<br />

6831 Korzeń podróz˙nika Herb HERBAPOL BIAŁYSTOK S.A. 31/12/08<br />

6832 Korzeń pokrzywy Herb HERBAPOL BIAŁYSTOK S.A. 31/12/08<br />

6833 Korzeń pokrzywy zweyczajnej Herb Flos, Mokrsko 31/12/08<br />

6834 Korzeń prawos´lazu Herbalux, Warszawa 26/03/06<br />

6835 Korzeń prawos´lazu Herbapol Lublin 26/03/06<br />

6836 Korzeń prawos´lazu Herbapol Pruszków 26/03/06


EN<br />

1052 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6837 Korzeń prawos´lazu Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6838 Korzeń prawos´lazu Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

6839 Korzeń prawos´lazu Zioła Lecznicze Boguccy,<br />

Kraków<br />

26/03/06<br />

26/03/06<br />

26/03/06<br />

6840 Korzeń prawos´lazu 1 Herbapol Kraków 31/12/06<br />

6841 Korzeń rzewienia Herbapol Lublin 31/12/07<br />

6842 Korzeń rzewienia Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6843 Korzeń rzewienia Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

6844 Korzeń rzewienia Zioła Lecznicze-Boguccy,<br />

Kraków<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

6845 Korzeń rzewienia 1 Herbapol Kraków 31/08/05<br />

6846 Korzeń rzewienia 1 i 2 Herbalux, Warszawa 19/05/06<br />

6847 Korzeń wilz˙yny Herbapol Białystok 13/05/06<br />

6848 Korzeń wilz˙yny Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6849 Korzeń wilz˙yny Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

13/05/06<br />

13/05/06<br />

6850 Korzeń wilz˙yny 1 i 2 Herbalux, Warszawa 14/08/07<br />

6851 Korzeń z˙eń-szenia Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

6852 Korzeń z˙eń-szenia Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

6853 Korzeń Z˙ywokostU Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

6854 Kosulvit Sulfadimidyna,<br />

Trimetovit,<br />

Witamina A<br />

Powder for veterinary<br />

use<br />

Drwalewskie Zakłady<br />

Bioweterynaryjnego ‘Polfa’<br />

31/01/05<br />

29/06/05<br />

30/10/05<br />

21/05/04<br />

6855 Koszyczek arniki Herbapol Białystok 13/05/06<br />

6856 Koszyczek arniki Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

6857 Koszyczek arniki Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

6858 Koszyczek arniki Zioła Lecznicze Boguccy,<br />

Kraków<br />

13/05/06<br />

13/05/06<br />

13/05/06<br />

6859 Koszyczek arniki 1 i 2 Herbalux, Warszawa 14/05/07<br />

6860 Koszyczek nagietka Calendulae anthodium Bags 1.0 g Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14/05/07<br />

6861 Koszyczek nagietka Calendulae anthodium Phytopharm Dobrzyca 14/05/07<br />

6862 Koszyczek nagietka Calendulae anthodium Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14/05/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1053<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6863 Koszyczek Nagietka Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

6864 Koszyczek Nagietka Herb Herba Lux s.c. Zakład<br />

Przetwórstwa Zielarskiego<br />

14/05/07<br />

31/12/08<br />

6865 Koszyczek nagietka 1 i 2 Calendulae anthodium Herbapol Kraków 9/11/06<br />

6866 Koszyczek Nagietka fix Herb Herba Lux s.c. Zakład<br />

Przetwórstwa Zielarskiego<br />

6867 Koszyczek rumianku Chamomille<br />

anthodium<br />

6868 Koszyczek rumianku Chamomille<br />

anthodium<br />

6869 Koszyczek rumianku Chamomille<br />

anthodium<br />

6870 Koszyczek rumianku Chamomille<br />

anthodium<br />

6871 Koszyczek rumianku Chemomille<br />

anthodium<br />

6872 Koszyczek rumianku (1 i 2) Chamomille<br />

anthodium<br />

6873 Koszyczek rumianku (1 i 2) Chamomille<br />

anthodium<br />

6874 Koszyczek rumianku (2) Chamomille<br />

anthodium<br />

6875 Koszyczek rumianku 1 i 2 Chamomille<br />

anthodium<br />

6876 Koszyczek rumianku 1 i 2 Chamomille<br />

anthodium<br />

6877 Koszyczek rumianku 1 i 2 Chamomille<br />

anthodium<br />

6878 Koszyczek rumianku 1 i 2 Chamomille<br />

anthodium<br />

6879 Koszyczek rumianku 1 i 2 Chamomille<br />

anthodium<br />

6880 Koszyczek rumianku 1 i 2<br />

(Chamo fix, Rumianek fix)<br />

Chamomille<br />

anthodium<br />

6881 Koszyczek rumianku 2 Chamomille<br />

anthodium<br />

6882 Koszyczek rumianku 2 Chamomille<br />

anthodium<br />

6883 Koszyczek rumianku 2 Chamomille<br />

anthodium<br />

6884 Koszyczek Rumianku -<br />

Anthodium Chamomillae<br />

6885 Koszyczek Rumianku fix -<br />

Anthodium Chamomillae<br />

31/12/08<br />

Bags 2 g PPH Biofluid 14/03/07<br />

Jukunda Naturarzneimittel 14/03/07<br />

Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

Zioła Lecznicze Boguccy,<br />

Kraków<br />

Bags 1.2 g Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

14/03/07<br />

14/03/07<br />

14/03/07<br />

Herbalux, Warszawa 31/12/08<br />

Herbapol Pruszków 31/12/08<br />

Elanda, Rozprza 30/04/06<br />

Herba Oskar, Wierzbówiec 31/12/08<br />

Herbapol Wrocław 31/12/08<br />

Varia, Katowice 31/12/08<br />

Zakład DARY NATURY,<br />

Grodzisk<br />

Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

31/12/08<br />

31/12/08<br />

Herbapol Lublin 2/11/07<br />

Phytopharm Dobrzyca 31/12/06<br />

Zakład Konfekcjonowania<br />

Ziół MALWA, Lubiszyn<br />

Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

31/12/06<br />

31/12/06<br />

31/12/08<br />

31/12/08


EN<br />

1054 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6886 KoszyCZk nagietka fix Herb Herbapol, Gdańsk 31/12/08<br />

6887 koszyczki nagietka Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

6888 Kredex Carvedilolum Tablets 12.5 mg SmithKline Beecham Pharma<br />

GmbH<br />

6889 Kredex Carvedilolum Tablets 25 mg SmithKline Beecham Pharma<br />

GmbH<br />

6890 Kredex Carvedilolum Tablets 6.25 mg SmithKline Beecham Pharma<br />

GmbH<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

6891 Krem ochronny >Chiet 6< Paste Farmina Sp. z o.o. 31/12/04<br />

6892 Krem Ochronny z Witamina˛ A Preparat złoz˙ony Laboratorium Galenowe<br />

‘LEFARM’ Sp. z o.o.<br />

6893 Krem propolisowy 1 % Cream Barć — Pasieka im. ks. dr<br />

Henryka Ostacha<br />

6894 Kreon 10 000 Amylasum + Lipasum +<br />

Proteasum<br />

6895 Kreon 25 000 Amylasum + Lipasum +<br />

Proteasum<br />

Capsules with pelets 150 mg Solvay Pharmaceuticals<br />

GmbH<br />

Capsules with<br />

microsphere<br />

300 mg Solvay Pharmaceuticals<br />

GmbH<br />

31/12/04<br />

31/12/04<br />

31/12/08<br />

31/05/05<br />

6896 Kreosotum complexe nr 62 Drops Lehning Laboratoires 24/08/06<br />

6897 Kromoglikan Acidum cromoglicicum Tablets for oral<br />

suspension<br />

100 mg Medana Pharma Terpol<br />

Group S.A.<br />

6898 Kromoglikan 2 % Cromoglycate disodium Solution for drink TERPOL Przedsiebiorstwo<br />

Farmaceutyczne S.A<br />

6899 Krople mie˛towe Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/05/05<br />

31/12/08<br />

30/06/05<br />

6900 Krople mie˛towe Hasco-Lek, Wrocław 30/06/05<br />

6901 Krople mie˛towe Herbapol Lublin 30/06/05<br />

6902 Krople nasercowe Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/08<br />

6903 Krople nasercowe Bonimed, Z˙ywiec 31/12/08<br />

6904 Krople nasercowe Cefarm Gdańsk 31/12/08<br />

6905 Krople nasercowe Cefarm Szczecin 31/12/08<br />

6906 Krople nasercowe Elanda, Rozprza 31/12/08<br />

6907 Krople nasercowe Farmina Sp. z o.o., Kraków 31/12/08<br />

6908 Krople nasercowe Hasco-Lek, Wrocław 31/12/08<br />

6909 Krople nasercowe Herbapol Kraków 31/12/08<br />

6910 Krople nasercowe Lefarm, Bydgoszcz 31/12/08<br />

6911 Krople nasercowe Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

31/12/08<br />

6912 Krople nasercowe Phytopharm Kle˛ka S.A. 31/12/08<br />

6913 Krople nasercowe PZF ‘Cefarm-Lublin’ S.A. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1055<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6914 Krople nasercowe Zakład Farmaceutyczny<br />

Amara, Kraków<br />

31/12/08<br />

6915 Krople nasercowe Cardiacol PPF GEMI, Karczew 4/09/07<br />

6916 Krople nasercowe z<br />

Wycia˛giem z zarodków kola<br />

Cardiacol C<br />

6917 Krople nasercowe z<br />

Wycia˛giem z zarodków Kola<br />

SERCOFIT<br />

PPF GEMI, Karczew 31/12/08<br />

Phytopharm Kle˛ka S.A. 30/11/06<br />

6918 Krople uspakajaja˛ce Hasco-Lek, Wrocław 31/12/07<br />

6919 Krople uspakajaja˛ce Herbapol Pruszków 31/12/07<br />

6920 Krople uspakajaja˛ce Phytopharm Kle˛ka S.A. 31/12/07<br />

6921 Krople uspakajaja˛ce Nervosol-K Herbapol Kraków 31/12/07<br />

6922 Krople uspokajaja˛ce PPF GEMI, Karczew 4/09/07<br />

6923 Krople uspokajaja˛ce Zakład Farmaceutyczny<br />

Amara, Kraków<br />

6924 Krople uspokajaja˛ce Liquid Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

6925 Krople walerianowe Aflofarm Farmacja Polska,<br />

Pabianice<br />

4/09/07<br />

31/12/08<br />

30/06/05<br />

6926 Krople walerianowe Hasco-Lek, Wrocław 30/06/05<br />

6927 Krople z˙oła˛dkowe Preparat ziołowy Oral drops Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

31/12/08<br />

6928 Krople z˙oła˛dkowe Drops Farmina Sp. z o.o. 31/12/08<br />

6929 Krople z˙oła˛dkowe Oral drops Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

22/05/06<br />

6930 Krople z˙oła˛dkowe forte Oral drops Herbapol Lublin S.A. 31/12/08<br />

6931 Krople z˙oła˛dkowe T Preparat ziołowy Oral drops Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

6932 Krople z˙oła˛dkowe T Preparat ziołowy Oral drops, solution Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

23/05/06<br />

30/10/05<br />

6933 Krople z˙oła˛dkowe t Preparat złoz˙ony Oral drops Phytopharm Kle˛ka S.A. 31/12/08<br />

6934 Kryptoscan (81mkr) Generator Preparat<br />

radiofarmaceutyczny<br />

Mallinckrodt Medical B.V. 31/12/08<br />

6935 Kuterid Betamethasonum Cream 0.64 mg/g Lek Pharmaceuticals d.d. 31/07/04<br />

6936 Kuterid Betamethasonum Ointment 0.64 mg/g Lek Pharmaceuticals d.d. 31/07/04<br />

6937 Kw iat wrzosu Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

6938 Kwai Film-coated tablets 0.1 g Lichtwer Pharma AG 31/12/08<br />

6939 Kwas acetylosalicylowy A.C.E.F., Włochy 31/12/08<br />

6940 Kwas acetylosalicylowy BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08


EN<br />

1056 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6941 Kwas acetylosalicylowy Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

31/12/08<br />

6942 Kwas acetylosalicylowy Pharma Cosmetic, Kraków 31/12/08<br />

6943 Kwas acetylosalicylowy PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

6944 Kwas acetylosalicylowy Zakłady Farmaceutyczne<br />

Polpharma SA, Starogard<br />

Gdański<br />

31/12/08<br />

31/12/08<br />

6945 Kwas askorbowy A.C.E.F., Włochy 31/12/08<br />

6946 Kwas askorbowy Pharma Cosmetic, Kraków 31/12/08<br />

6947 Kwas askorbowy Pliva Kraków 31/12/08<br />

6948 Kwas askorbowy Acidum ascorbicum Powder for veterinary<br />

use<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

6949 Kwas benzoesowy Margo Corporation,<br />

Warszawa<br />

31/12/08<br />

31/12/08<br />

6950 Kwas benzoesowy Pharma Cosmetic, Kraków 31/12/08<br />

6951 Kwas benzoesowy Pharma Zentrale 31/12/08<br />

6952 Kwas benzoesowy PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

6953 Kwas borowy Aflofarm Fabryka Leków,<br />

Ksawerów<br />

6954 Kwas borowy Aflofarm Farmacja Polska,<br />

Pabianice<br />

6955 Kwas borowy BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08<br />

24/07/06<br />

24/07/06<br />

24/07/06<br />

6956 Kwas borowy Cefarm Gdańsk 24/07/06<br />

6957 Kwas borowy Farm-Impex s.j., Gliwice 24/07/06<br />

6958 Kwas borowy Hasco-Lek, Wrocław 24/07/06<br />

6959 Kwas borowy Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

6960 Kwas borowy Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

24/07/06<br />

24/07/06<br />

6961 Kwas borowy Lefarm, Bydgoszcz 24/07/06<br />

6962 Kwas borowy Maga-Herba s.c., Legionowo 24/07/06<br />

6963 Kwas borowy Pampa, Piaseczno 24/07/06<br />

6964 Kwas borowy Pharma Cosmetic, Kraków 24/07/06<br />

6965 Kwas borowy Pharma Zentrale 24/07/06<br />

6966 Kwas borowy Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

6967 Kwas borowy PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

24/07/06<br />

24/07/06<br />

6968 Kwas borowy Prolab, Paterek k/Nakła 24/07/06<br />

6969 Kwas borowy PZF ‘Cefarm-Lublin’ S.A. 24/07/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1057<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6970 Kwas borowy Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

6971 Kwas cytrynowy Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

24/07/06<br />

9/10/06<br />

6972 Kwas cytrynowy Pharma Cosmetic, Kraków 9/10/06<br />

6973 Kwas cytrynowy Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

6974 Kwas cytrynowy PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

9/10/06<br />

9/10/06<br />

6975 Kwas foliowy Acidum folicum Tablets 400 mcg Puritan's Pride, Incorporated 30/09/04<br />

6976 Kwas foliowy (Folvita) Acidum folicum Oral capsules 400 mcg Healthilife Limited 31/12/08<br />

6977 Kwas mlekowy Acidum lacticum BUFA b.v. Pharmaceutical<br />

Products<br />

30/11/05<br />

6978 Kwas mlekowy Acidum lacticum Pharma Cosmetic, Kraków 30/11/05<br />

6979 Kwas mlekowy Acidum lacticum Pharma Zentrale 30/11/05<br />

6980 Kwas mlekowy Acidum lacticum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

6981 Kwas mlekowy Acidum lacticum Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

30/11/05<br />

30/11/05<br />

6982 Kwas mlekowy 50 % Acidum lacticum Chema Elektromet, Rzeszów 31/12/08<br />

6983 Kwas octowy A.C.E.F. , Włochy 30/09/05<br />

6984 Kwas salicylowy A.C.E.F., Włochy 31/12/08<br />

6985 Kwas salicylowy BUFA b.v. Pharmaceutical<br />

Products<br />

6986 Kwas salicylowy Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

31/12/08<br />

6987 Kwas salicylowy Pampa, Piaseczno 31/12/08<br />

6988 Kwas salicylowy Pharma Cosmetic, Kraków 31/12/08<br />

6989 Kwas salicylowy Pharma Zentrale 31/12/08<br />

6990 Kwas salicylowy PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

6991 Kwas salicylowy Zakłady Farmaceutyczne<br />

Polpharma SA, Starogard<br />

Gdański<br />

31/12/08<br />

31/12/08<br />

6992 Kwas solny 10 % Pampa, Piaseczno 31/10/05<br />

6993 Kwas solny 35 % A.C.E.F., Włochy 31/12/08<br />

6994 Kwas winowy Margo Corporation,<br />

Warszawa<br />

6995 Kwas winowy Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

31/12/08<br />

31/12/08<br />

6996 Kwetiapina Quetiapinum Film-coated tablets 25 mg POL-NIL Sp. z.o.o. 31/12/08<br />

6997 Kwetiapina Quetiapinum Film-coated tablets 100 mg POL-NIL Sp. z.o.o. 31/12/08


EN<br />

1058 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

6998 Kwetiapina Quetiapinum Film-coated tablets 200 mg POL-NIL Sp. z.o.o. 31/12/08<br />

6999 Kwiat s´lazu Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

31/12/08<br />

7000 Kwiat Akacji Herb Herbapol Lublin S.A. 31/01/05<br />

7001 Kwiat akacji białej Herb Kawon, Gostyń 31/12/08<br />

7002 Kwiat bławatka Herb Kawon, Gostyń 31/12/08<br />

7003 Kwiat Bławatka Herb Herbapol Lublin S.A. 31/01/05<br />

7004 Kwiat bzu czarnego Sambuci flos Herbalux, Warszawa 26/03/06<br />

7005 Kwiat bzu czarnego Sambuci flos Phytopharm Dobrzyca 26/03/06<br />

7006 Kwiat bzu czarnego Sambuci flos Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7007 Kwiat bzu czarnego Sambuci flos Zioła Lecznicze Boguccy,<br />

Kraków<br />

7008 Kwiat bzu czarnego (1 i 2) Sambuci flos Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

26/03/06<br />

26/03/06<br />

31/12/05<br />

7009 Kwiat bzu czarnego 1 Sambuci flos Herbapol Kraków 31/12/05<br />

7010 Kwiat bzu czarnego 1 i 2 Sambuci flos Elanda, Rozprza 24/05/06<br />

7011 Kwiat bzu czarnego 1 i 2 Sambuci flos Herbapol Wrocław 24/05/06<br />

7012 Kwiat bzu czarnego 1 i 2<br />

(Sambucus fix, Bez czarny fix)<br />

Sambuci flos Herbapol Lublin 2/11/07<br />

7013 Kwiat bzu czarnego 2 Sambuci flos Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

30/06/06<br />

7014 Kwiat dziewanny Herbalux, Warszawa 14/05/07<br />

7015 Kwiat dziewanny Herbapol Lublin 14/05/07<br />

7016 Kwiat dziewanny Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7017 Kwiat dziewanny Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14/05/07<br />

14/05/07<br />

7018 Kwiat Jasnoty Herb Herbapol Lublin S.A. 30/10/05<br />

7019 Kwiat Jasnoty Bialej Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

7020 Kwiat jasnoty białej Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

30/10/05<br />

31/12/08<br />

7021 Kwiat jasnoty białej Herb Herbapol, Bydgoszcz 31/12/08<br />

7022 Kwiat jasnoty białej Herb Herbapol, Gdańsk 31/12/08<br />

7023 Kwiat jasnoty białej Herb Kawon, Gostyń 31/12/08<br />

7024 Kwiat Jasnoty Białej Herb Herba Lux s.c. Zakład<br />

Przetwórstwa Zielarskiego<br />

31/12/08<br />

7025 Kwiat jasnoty białej fix Herb Herbapol, Gdańsk 31/12/08<br />

7026 Kwiat Kasztanowca Hippocastani flos Herb Herbapol Lublin S.A. 31/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1059<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7027 Kwiat Kasztanowca Hippocastani flos Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

7028 Kwiat kasztanowca Hippocastani flos Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

7029 Kwiat kasztanowca Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/07<br />

31/12/08<br />

31/12/08<br />

7030 Kwiat kasztanowca Herb Herbapol, Gdańsk 31/12/08<br />

7031 Kwiat krwawnika Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

7032 Kwiat Krwawnika Herb Herbapol Lublin S.A. 30/10/05<br />

7033 Kwiat Krwawnika Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

31/01/06<br />

7034 Kwiat lawendy Herbapol Lublin 31/12/07<br />

7035 Kwiat lawendy Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7036 Kwiat lawendy Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/12/07<br />

31/12/07<br />

7037 Kwiat lawendy 1 Herbapol Kraków 31/08/05<br />

7038 Kwiat lawendy 1 Zioła Lecznicze Boguccy,<br />

Kraków<br />

31/08/05<br />

7039 Kwiat lawendy 1 i 2 Herbalux, Warszawa 24/05/07<br />

7040 Kwiat lipy Herbapol Łódz´ 31/12/07<br />

7041 Kwiat Lipy fix -Inflorescentia<br />

Tiliae<br />

7042 Kwiat Lipy -Inflorescentia<br />

Tiliae<br />

Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

7043 Kwiat malwy Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

31/12/04<br />

31/12/04<br />

18/12/05<br />

7044 Kwiat Malwy czarnej Herb Herbapol Lublin S.A. 19/05/06<br />

7045 Kwiat malwy czarnej Herbalux, Warszawa 19/05/06<br />

7046 Kwiat malwy czarnej Herbapol Pruszków 19/05/06<br />

7047 Kwiat nagietka Herb Bydgoskie Zakłady Zielarskie<br />

‘Herbapol’<br />

31/12/08<br />

7048 Kwiat nagietka Herb Herbapol, Gdańsk 31/12/08<br />

7049 Kwiat Nagietka Herb Zioła Lecznicze — Boguccy<br />

s.c.<br />

7050 Kwiat Nagietka Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/10/05<br />

30/10/05<br />

7051 Kwiat Nagietka Herb Herbapol Lublin S.A. 30/10/05<br />

7052 Kwiat Nagietka Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

30/10/05


EN<br />

1060 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7053 Kwiat podbiału Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

7054 Kwiat przelotu Herb HERBAPOL BIAŁYSTOK S.A. 31/12/08<br />

7055 Kwiat rumianku Herbapol Kraków 5/02/05<br />

7056 Kwiat rumianku Herbapol Łódz´ 5/02/05<br />

7057 Kwiat rumianku Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

7058 Kwiat Rumianku rzymskiego Herb Herbapol Lublin S.A. 31/01/05<br />

7059 Kwiat s´lazu Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7060 Kwiat wia˛zówki Ulmariae flos A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

31/03/05<br />

19/07/07<br />

7061 Kwiat wia˛zówki Ulmariae flos Herbapol Lublin 19/07/07<br />

7062 Kwiat wia˛zówki Ulmariae flos Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7063 Kwiat wia˛zówki Ulmariae flos Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7064 Kwiat wia˛zówki Ulmariae flos Zioła Lecznicze Boguccy,<br />

Kraków<br />

19/07/07<br />

19/07/07<br />

19/07/07<br />

7065 Kwiat wia˛zówki 1 i 2 Ulmariae flos Herbalux, Warszawa 24/05/07<br />

7066 Kwiat Wia˛zówki -Flos<br />

Ulmariae<br />

Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

31/12/04<br />

7067 Kwiat wrzosu Herb Bogucki, Kraków 31/12/08<br />

7068 Kwiat wrzosu Herb Herbapol, Gdańsk 31/12/08<br />

7069 Kwiat Wrzosu Herb Herbapol Lublin S.A. 31/01/05<br />

7070 Kwiat wrzosu fix Herb Herbapol, Gdańsk 31/12/08<br />

7071 Kwiat Wrzosu -Flos Ericae Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

7072 Kwiatostan głogu Crataegi inflorescentia Herb in bags Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

7073 Kwiatostan głogu Crataegi inflorescentia Herb in bags Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7074 Kwiatostan głogu Crataegi inflorescentia Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7075 Kwiatostan głogu Crataegi inflorescentia Zioła Lecznicze, Boguccy,<br />

Kraków<br />

7076 Kwiatostan głogu Crataegi inflorescentia Capsules 243 mg Aflofarm Fabryka Leków,<br />

Ksawerów<br />

31/12/04<br />

30/08/07<br />

30/08/07<br />

30/08/07<br />

30/08/07<br />

28/02/06<br />

7077 Kwiatostan głogu (1 i 2) Crataegi inflorescentia Herba Oskar, Wierzbówiec 31/12/08<br />

7078 Kwiatostan głogu (Crataegus<br />

fix, Kwiat głogu fix)<br />

Crataegi inflorescentia Herbapol Lublin 14/09/07<br />

7079 Kwiatostan głogu 1 i 2 Crataegi inflorescentia Herbalux, Warszawa 26/03/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1061<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7080 Kwiatostan głogu 1 i 2 Crataegi inflorescentia Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

26/03/06<br />

7081 Kwiatostan głogu 2 Crataegi inflorescentia Herbapol Wrocław 24/03/07<br />

7082 Kwiatostan głogu 2 Crataegi inflorescentia Phytopharm Dobrzyca 24/03/07<br />

7083 Kwiatostan głogu kaps.270 mg Crataegi inflorescentia Phytopharm Kle˛ka S.A. 31/01/06<br />

7084 Kwiatostan kocanek Herbalux, Warszawa 28/02/06<br />

7085 Kwiatostan kocanek Herbapol Lublin 28/02/06<br />

7086 Kwiatostan kocanek Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7087 Kwiatostan kocanek Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

28/02/06<br />

28/02/06<br />

7088 Kwiatostan kocanek 1 Herbapol Kraków 31/08/05<br />

7089 Kwiatostan kocanek 1 Herbapol Pruszków 31/08/05<br />

7090 Kwiatostan kocanek 1 Zioła Lecznicze Boguccy,<br />

Kraków<br />

7091 Kwiatostan Lawendy -Flos<br />

Lavandulae<br />

Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

7092 Kwiatostan lipy Tiliae inflorescentia Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7093 Kwiatostan lipy Tiliae inflorescentia Capsules 400 mg Aflofarm Fabryka Leków,<br />

Ksawerów<br />

31/08/05<br />

31/12/04<br />

31/12/08<br />

28/02/06<br />

7094 Kwiatostan lipy (1 i 2) Tiliae inflorescentia Herbalux, Warszawa 31/12/08<br />

7095 Kwiatostan lipy (1 i 2) Tiliae inflorescentia Herbapol Pruszków 31/12/08<br />

7096 Kwiatostan lipy 1 Tiliae inflorescentia Zioła Lecznicze Boguccy,<br />

Kraków<br />

31/07/05<br />

7097 Kwiatostan lipy 1 i 2 Tiliae inflorescentia Herbapol Kraków 30/11/05<br />

7098 Kwiatostan lipy 1 i 2 Tiliae inflorescentia Herbapol Wrocław 30/11/05<br />

7099 Kwiatostan lipy 1 i 2 Tiliae inflorescentia Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7100 Kwiatostan lipy 1 i 2 (Tilia fix,<br />

Lipa fix)<br />

30/11/05<br />

Tiliae inflorescentia Herbapol Lublin 2/11/07<br />

7101 Kwiatostan lipy 2 Tiliae inflorescentia Phytopharm Dobrzyca 19/11/06<br />

7102 Kwiatostan lipy 2 Tiliae inflorescentia Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7103 Kybernin P Antithrombinum III Intravenous injection<br />

(lyophilisate)<br />

7104 Kybernin P Antithrombinum III Intravenous injection<br />

(lyophilisate)<br />

19/11/06<br />

1000 j.m. Centeon Pharma GmbH 31/12/08<br />

500 j.m. Centeon Pharma GmbH 31/12/08<br />

7106 Kytril Granisetronum Film-coated tablets 1 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

7105 Kytril Granisetronum Solution for<br />

intravenous infusion<br />

1 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

30/06/07<br />

1/04/06<br />

7107 L 25 Lehning Laboratoires 31/12/08


EN<br />

1062 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7108 L 28 Drops Lehning Laboratoires 31/12/08<br />

7109 L 8 Lehning Laboratoires 31/12/08<br />

7110 L.52 Drops Lehning Laboratoires 31/12/08<br />

7111 L.72 Drops Lehning Laboratoires 31/12/08<br />

7112 L-114 Drops Lehning Laboratoires 31/10/05<br />

7113 Labufen Ibuprofenum Film-coated tablets 200 mg Labpharm Sp. z.o.o. 31/12/08<br />

7114 Labufen Forte Ibuprofenum Film-coated tablets 400 mg Labpharm Sp. z.o.o. 31/12/08<br />

7115 LACHESIS comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

7116 LACHESIS comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

7117 Lachesis Complexe Nr 70 Drops Lehning Laboratoires 31/12/08<br />

7118 Lacidofil Lactobacillus acidophilus<br />

+ Lactobacillus<br />

rhamnosus<br />

Capsules 2 mld CFU Institut Rosell Inc. 31/07/04<br />

7119 Lacipil Lacidipinum Film-coated tablets 2 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

7120 Lacipil Lacidipinum Film-coated tablets 4 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

7121 Lacrimal Alcohol polivinylicus Eye drops, solution 14 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

7122 Lactaclox Ampicillinum +<br />

Cloxacillinum<br />

7123 Lactiovit Witaminy +<br />

Lactobacillus acidophilus<br />

Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

Buccal tablets preparat<br />

złoz˙ony<br />

4/01/06<br />

4/01/06<br />

30/11/05<br />

Norbrook Lab. 1/08/04<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

7124 Lactitol Lactitolum Powder 10 g Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

7125 Lactobac Plus Bakterie Capsules Wytwórnia Surowic i<br />

Szczepionek BIOMED<br />

7126 Lactobif Oral lyophilisate Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

7127 Lactocin Oxytocinum Solution for veterinary<br />

use<br />

7128 Lactoderm SBU 40 %, kwas<br />

mlekowy, glicerol,<br />

pioktanina<br />

7129 Lactolyte Serwatka odwodniona,<br />

Sodu octan bezwodny,<br />

Sodu propionian<br />

bezwodny, Sodu<br />

chlorek bezwodny,<br />

Potasu chlorek<br />

bezwodny,<br />

Jednopotasowy<br />

fosforan bezwodny<br />

Liquid for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Zakła˛dy Farmaceutyczne<br />

‘Biowet’ Sp. z o.o.<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

31/12/08<br />

29/06/05<br />

31/12/08<br />

30/09/05<br />

22/05/07<br />

11/03/04<br />

Virbac 18/08/05<br />

7130 Lactosanol Tilactasum Capsules 250 mg Schwarz Pharma Sp. z o.o. 31/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1063<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7131 Lactovaginal Lactobacillus rhamnosus Vaginal capsules ok.<br />

10 000 mln (w<br />

tym nie mniej<br />

niz˙ 100 mln<br />

CFU) pałeczek<br />

L. Rhamnosus<br />

7132 Lactovaginal Organizmy produkuja˛ce<br />

kwas mlekowy<br />

Pessary 10 mld<br />

komórek<br />

Wytwórnia Surowic i<br />

Szczepionek ‘BIOMED’ S.A.,<br />

Kraków<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

7133 Lactulol Lactulosum Syrup 2,5 g/5 ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

30/09/05<br />

30/09/07<br />

31/12/08<br />

7134 Lactulose — Mip Lactulasum Syrup 3,25 g/5 ml CHEPHASAAR GmbH 31/12/08<br />

7135 Lactulosum Lactulosum Syrup 2.5 g/5 ml Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

31/12/05<br />

7136 Lactulosum Lactulosum Syrup 7.5 g/15 ml Polfarmex S.A 30/06/06<br />

7137 Lactulosum Lactulosum Syrup 7.5 g/15 ml Aflofarm Farmacia Polska Sp.<br />

z o.o.<br />

7138 Lagosa Coated tablets 150 mg Waerwag Pharma GmbH &<br />

Co<br />

7139 Laif 600 Hyperici extractum<br />

siccum<br />

7140 Lakcid Lactobacillus rhamnosus Lyophilisate for oral<br />

suspension<br />

7141 Lakcid L Powder for<br />

suspension<br />

7142 Lakcid forte Lactobacillus rhamnosus Lyophilisate for oral<br />

suspension<br />

7143 Lakcid forte 20 Lactobacillus rhamnosus Lyophilisate for oral<br />

suspension<br />

7144 Laksen Sennae fructus extractum<br />

siccum<br />

Film-coated tablets 612 mg Steigerwald Arzneimittelwerk<br />

GmbH<br />

co najmniej<br />

100 mln. CFU<br />

pałeczek<br />

Lactobacillus<br />

rhamnosus —<br />

1 dawka<br />

1,2 mld<br />

bakterii<br />

co najmniej<br />

400 mln CFU<br />

pałeczek<br />

Lactobacillus<br />

rhamnosus —<br />

1 dawka<br />

co najmniej<br />

8 mld CFU<br />

pałeczek<br />

Lactobacillus<br />

rhamnosus —<br />

20 dawek<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

BIOMED Wytwórnia Surowic<br />

i Szczepionek Spółka z o.o.<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

Tablets 75 mg Zakłady Farmaceutyczne<br />

COLFARM S.A., Mielec<br />

7145 Laktomag Magnesii hydroaspartas Tablets 70 mg Mg ++ Chance — Zakład Produkcji<br />

Chemiczno —<br />

Farmaceutycznej s.c.<br />

7146 Laktomag B6 Magnesii hydroaspartas<br />

+ Pyridoxinum (vit B6)<br />

Tablets Chance — Zakład Produkcji<br />

Chemiczno —<br />

Farmaceutycznej s.c.<br />

7147 Laktoza BUFA b.v. Pharmaceutical<br />

Products<br />

6/06/07<br />

31/08/05<br />

31/12/08<br />

31/01/05<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

31/01/06<br />

30/06/05<br />

30/11/05<br />

7148 Laktoza El Virus, Siemianowice 30/11/05<br />

7149 Laktoza Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

30/11/05


EN<br />

1064 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7150 Laktoza Pharma Cosmetic, Kraków 30/11/05<br />

7151 Laktoza Pharma Zentrale 30/11/05<br />

7152 Laktoza PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

30/11/05<br />

7153 Laktoza Scholz, Sowin 30/11/05<br />

7154 Lametta Letrozolum Film-coated tablets 2,5 mg VIPHARM S.A. Warszawa 31/12/08<br />

7155 Lamictal Lamotriginum Tablets 100 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

7156 Lamictal Lamotriginum Tablets 100 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

7157 Lamictal Lamotriginum Tablets 25 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

7158 Lamictal Lamotriginum Tablets 25 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

7159 Lamictal Lamotriginum Tablets 50 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

7160 Lamictal Lamotriginum Tablets 50 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

7164 Lamictal S Lamotriginum Tablets for oral<br />

solution<br />

7161 Lamictal S Lamotriginum Tablets for oral<br />

suspension<br />

7162 Lamictal S Lamotriginum Tablets for oral<br />

suspension<br />

7163 Lamictal S Lamotriginum Tablets for oral<br />

suspension<br />

2 mg Glaxo Wellcome House,<br />

Glaxo Wellcome Group<br />

100 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

25 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

5 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

30/04/05<br />

30/04/05<br />

31/05/05<br />

31/05/05<br />

30/04/05<br />

30/04/05<br />

6/06/07<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

7165 Lamioflur Drops Heel GmbH 31/12/08<br />

7166 Lamisil Terbinafinum Tablets 125 mg Novartis Pharma AG 31/05/04<br />

7167 Lamisil Terbinafinum Tablets 250 mg Novartis Pharma AG 31/05/04<br />

7169 Lamisilatt Terbinafinum Coutanous liquid 1 % Novartis Consumer Health<br />

S.A.<br />

7168 Lamisilatt Terbinafinum Cream 10 mg/g Novartis Consumer Health<br />

S.A.<br />

7170 Lamisilatt Terbinafinum Cutaneous spray,<br />

solution<br />

1 % Novartis Consumer Health<br />

S.A.<br />

7171 Lamisilatt Dermgel Terbinafinum Gel 10 mg/g Novartis Consumer Health<br />

S.A.<br />

7172 Lamotirgine Lamotriginum Tablets 100 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

7173 Lamotragine Lamotriginum Tablets 50 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/12/08<br />

31/05/04<br />

31/12/08<br />

30/06/05<br />

31/12/08<br />

31/12/08<br />

7174 Lamotrigin Lamotriginum Tablets 25 mg POLFA KUTNO S.A. 31/12/08<br />

7175 Lamotrigin Lamotriginum Tablets 50 mg POLFA KUTNO S.A. 31/12/08<br />

7176 Lamotrigin Lamotriginum Tablets 100 mg POLFA KUTNO S.A. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1065<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7177 Lamotrigine Lamotriginum Tablets 25 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

7178 Lamotrix Lamotriginum Tablets 25 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

7179 Lamotrix Lamotriginum Tablets 50 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

7180 Lamotrix Lamotriginum Tablets 100 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

7181 Lancetan Plantaginis lanceolatae<br />

extractum fluidum<br />

7182 Lanceticum Plantaginis lanceolatae<br />

extractum fluidum +<br />

Preparat ziołowy<br />

Syrup 648 mg/5 ml Prolab s.c. — Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Produkcyjno-Analityczno-<br />

Handlowe s.c. Paterek<br />

Syrup 318 mg/5ml Naturwaren OHG Dr Peter<br />

Theiss<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

9/08/06<br />

31/05/04<br />

7183 Landicor Metildigoxinum Tablets 0.1 mg Nobilus Ent 30/06/05<br />

7184 Lanolina A.C.E.F., Włochy 31/12/08<br />

7185 Lanolina AUGMED, Dawidy Bankowe 31/12/08<br />

7186 Lanolina Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

31/12/08<br />

7187 Lanolina Pampa, Piaseczno 31/12/08<br />

7188 Lanolina Pharma Cosmetic, Kraków 31/12/08<br />

7189 Lanolina PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

7190 Lanolina bezwodna Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/08<br />

5/08/05<br />

7191 Lanolina bezwodna Cefarm Gdańsk 5/08/05<br />

7192 Lanolina bezwodna Hasco-Lek, Wrocław 5/08/05<br />

7193 Lanolina bezwodna Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

5/08/05<br />

7194 Lanolina bezwodna Lefarm, Bydgoszcz 5/08/05<br />

7195 Lanolina bezwodna PPF GEMI, Karczew 5/08/05<br />

7196 Lanolina bezwodna PZF ‘Cefarm-Lublin’ S.A. 5/08/05<br />

7197 Lanolina bezwodna Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

5/08/05<br />

7198 Lansone Lansoprazolum Capsules 30 mg Gedeon Richter Ltd. 29/11/06<br />

7199 Lansoprazole Lansoprazole Capsules 30 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

7200 Lansoprazole Lansoprazolum Capsules 15 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

7201 Lantus Insulinum glargine Solution for injection 100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

7202 Lantus Insulinum glargine Solution for injection 100 j.m/ml Aventis Pharma Deutschland<br />

GmbH<br />

31/12/08<br />

31/12/08<br />

7/03/07<br />

21/06/06


EN<br />

1066 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7203 Lantus Optiset Insulinum glargine Solution for injection 100 j.m./ml Aventis Pharma Deutschland<br />

GmbH<br />

7204 Lanvis Tioguaninum Tablets 40 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

7/03/07<br />

30/06/04<br />

7205 Lanzul Lansoprazolum Capsules 30 mg Krka d.d., Novo mesto 31/12/07<br />

7206 Lanzul S Lansoprazolum Capsules 15 mg Krka d.d., Novo mesto 15/03/06<br />

7207 Largal Ultra Cetrimidum+ Natrii<br />

edetas<br />

7208 Larvac Atenuowana<br />

szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu krtani i<br />

tchawicy<br />

Liquid (7,5mg +<br />

150mg)/ml<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Septodont 30/04/04<br />

FATRO 29/08/06<br />

7209 LARYNX/APIS comp. ampułki WALA-Heilmittel GmbH 19/03/05<br />

7210 LARYNX/APIS comp. granulki WALA-Heilmittel GmbH 19/03/05<br />

7211 Laspal Acidum acetylsalicylicum Powder and solvent<br />

for solution for<br />

injection<br />

900 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

30/11/04<br />

7212 Lastet Etoposidum Capsules 100 mg Nippon Kayaku Co. Ltd. 31/07/04<br />

7213 Lastet Etoposidum Capsules 25 mg Nippon Kayaku Co. Ltd. 31/07/04<br />

7214 Lastet Etoposidum Capsules 50 mg Nippon Kayaku Co. Ltd. 31/07/04<br />

7215 Lastet Etoposidum Solution for injection 20 mg/ml Nippon Kayaku Co. Ltd. 31/07/04<br />

7216 Latensin D4 iniekcje Sanum-Kehlbeck 31/12/05<br />

7217 Latensin D4 kaps. Sanum-Kehlbeck 31/12/05<br />

7218 Latensin D6 iniekcje Sanum-Kehlbeck 31/12/05<br />

7219 Latensin D6 Kapsułki Sanum-Kehlbeck 31/12/05<br />

7222 Laticort 0,1 % Hydrocortisoni butyras Coutanous liquid 1 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

7220 Laticort 0,1 % Hydrocortisoni butyras Cream 1 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

7221 Laticort 0,1 % Hydrocortisoni butyras Ointment 1 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

7223 Laticort-CH Chlorquinaldolum +<br />

Hydrocortisoni butyras<br />

7224 Laticort-CH Chlorquinaldolum +<br />

Hydrocortisoni butyras<br />

7225 Laudin Tetracykliny<br />

chlorowodorek,<br />

Erytromycyny<br />

propionianu<br />

laurylosiarczan<br />

7226 Laurina Desogestrelum +<br />

Ethinylestradiolum<br />

7<strong>227</strong> Lautecin Erythromycinum +<br />

Tetracicllinum<br />

Cream (30mg + 1mg)/<br />

g<br />

Ointment (30mg + 1mg)/<br />

g<br />

Powder for veterinary<br />

use<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

30/11/05<br />

30/11/05<br />

31/01/06<br />

30/11/05<br />

30/11/05<br />

30/06/04<br />

Tablets Organon 31/12/08<br />

Powder for veterinary<br />

use<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

10/05/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1067<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7228 Lautecin granulat 6,6 %/3,4 % Estolan erytromycyny,<br />

chlorowodorek<br />

tetracykliny<br />

Granules for veterinary<br />

use<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

7229 Lawenol -spirytus lawendowy Lavandulae oleum Liquid Prolab s.c. — Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Produkcyjno-Analityczno-<br />

Handlowe s.c. Paterek<br />

7230 Laxacur Plantaginis ovatae testa Granules for oral<br />

solution<br />

31/12/08<br />

31/12/08<br />

3250 mg/5 g Biocur Arzneimittel GmbH 30/11/04<br />

7231 Laxaflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

29/01/06<br />

7232 Laxalpin F.Joh. Kwizda GmbH 31/12/08<br />

7233 Laxamix Sennae folium pulv.,<br />

Plantaginis ovatae testa<br />

pulv.<br />

7234 Laxamix 1 Plantaginis ovatae testa<br />

+ Sennae folium<br />

Capsules, hard Agropharm S.A. 31/12/08<br />

Capsuels, hard 488mg +<br />

122mg<br />

Agropharm S.A. 25/10/06<br />

7235 Laxantia Tea Herbal tea Elanda s.c. — Zakład<br />

Produkcji S´ rodków<br />

Farmaceutycznych<br />

7236 Laxantol Frangulae cortex extr.,<br />

Rhei radix extr.<br />

Oral solution Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

29/05/05<br />

31/12/08<br />

7237 Laxitab Film-coated tablets 0.2 g P.P.H.U. Biofarm Sp. z o.o. 31/12/08<br />

7238 Laxol Docusatum natricum Suppository 100 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

7239 Laxopol Docusatum natricum Oral solution 5 mg/ml Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

7240 Laxopol Docusatum natricum Syrup 4 mg/ml Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

7241 Lecigal Capsules, soft Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

7242 Lecitan Oral emulsion 500 mg/5ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

23/11/05<br />

30/11/05<br />

7243 Lecithin 1200 Capsules 1200 mg Power Health Products Ltd. 31/07/04<br />

7244 Lecrolyn 2 % Acidum cromoglicicum Eye drops 20 mg/ml Santen Oy 31/07/04<br />

7245 Lecrolyn 2 % Acidum cromoglicicum Eye drops 5 mg/0,25 ml Santen Oy 31/07/04<br />

7246 Lecrolyn 4 % Acidum cromoglicicum Eye drops, solution 40 mg/ml Santen Oy 14/02/07<br />

7247 Lecrolyn 4 % Acidum cromoglicicum Eye drops, solution 40 mg/ml Santen Oy 14/02/07<br />

7248 Lecur Phospholipidum ex soja,<br />

Vitaminum E<br />

7249 Lecyfort Witamina a, d3, e,<br />

lecytyna sojowa, olej<br />

wiesiołkowy, olej<br />

lniany<br />

Capsules 100 mg +<br />

200 mg<br />

Liquid for veterinary<br />

use<br />

PT. Dexa Medica 31/12/08<br />

Biowet Puławy 31/12/08<br />

7250 Lecytyna E Film-coated tablets Krka d.d., Novo mesto 31/07/04<br />

7251 Lecytyna Plus Oral solution Krka d.d., Novo mesto 31/07/04


EN<br />

1068 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7252 Lefax Simeticonum Chewable tablets 42 mg Asche AG 31/08/05<br />

7253 Legalon 140 Capsules 140 mg Madaus AG 31/01/05<br />

7254 Legalon 70 Coated tablets 70 mg Madaus AG 31/01/05<br />

7255 Lekadol Paracetamolum Tablets 0.5 g Lek Pharmaceuticals d.d. 31/12/06<br />

7256 Lekobaza Ointment base Lek Pharmaceuticals d.d. 31/07/04<br />

7257 Lekoklar Clarithromycinum Film-coated tablets 250 mg Lek Pharmaceuticals d.d. 29/11/06<br />

7258 Lekoklar Clarithromycinum Film-coated tablets 500 mg Lek Pharmaceuticals d.d. 29/11/06<br />

7259 Lekomycin — P Lincomycinum +<br />

Gentamicinum<br />

7260 Lekomycin P — roztwór Lincomycinum +<br />

Gentamicinum<br />

Powder for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Lek Pharmaceuti-cal 31/12/08<br />

Lek Pharmaceutical and<br />

Chemical Company<br />

7261 Lekoprost Finasteridum Film-coated tablets 5 mg Chemical Works of Gedeon<br />

Richter Ltd.<br />

10/02/04<br />

31/12/08<br />

7262 Lekoptin Verapamilum Coated tablets 120 mg Lek Pharmaceuticals d.d. 30/06/04<br />

7263 Lekoptin Verapamilum Coated tablets 120 mg Lek Polska Sp. z o.o. 31/12/05<br />

7264 Lekoptin Verapamilum Coated tablets 40 mg Lek Pharmaceuticals d.d. 30/06/04<br />

7265 Lekoptin Verapamilum Coated tablets 40 mg Lek Polska Sp. z o.o. 31/12/05<br />

7266 Lekoptin Verapamilum Coated tablets 80 mg Lek Pharmaceuticals d.d. 30/06/04<br />

7267 Lekoptin Verapamilum Coated tablets 80 mg Lek Polska Sp. z o.o. 31/12/05<br />

7268 Lekoptin Verapamilum Solution for injection 2.5 mg/ml Lek Pharmaceuticals d.d. 30/06/04<br />

7269 Lekoptin Retard Verapamilum Film-coated tablets 240 mg Lek Pharmaceuticals d.d. 31/12/04<br />

7270 Lekoptin Retard Verapamilum Film-coated tablets 240 mg Lek Polska Sp. z o.o. 30/10/05<br />

7271 Lekosen Film-coated tablets Lek Pharmaceuticals d.d. 30/04/04<br />

7272 Lekovit Buccal tablets Lek Pharmaceuticals d.d. 31/12/07<br />

7273 Lekovit Effervescent tablets Lek Pharmaceuticals d.d. 31/12/07<br />

7275 Lendacin Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

7276 Lendacin Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

7274 Lendacin Ceftriaxonum Powder for solution<br />

for intravenous<br />

infusion<br />

7277 Lenograstinum Lenograstinum Lyophilisate for<br />

solution for<br />

subcutaneous<br />

injection and<br />

intravenous infusion<br />

7278 Lente MC Insulini cum Zinco<br />

suspensio<br />

Suspension for<br />

injection<br />

1 g Lek Pharmaceuticals d.d. 31/05/05<br />

250 mg Lek Pharmaceuticals d.d. 31/05/05<br />

2 g Lek Pharmaceuticals d.d. 31/12/08<br />

33,6 MIU Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

40 j.m./ml Novo Nordisk A/S 31/07/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1069<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7279 LENTE MC 100 J.M./Ml Insulini cum Zinco<br />

suspensio<br />

Suspension for<br />

subcutaneous<br />

injection<br />

100 j.m./ml Novo Nordisk A/S 31/12/08<br />

7280 Leocard Liquid Phytopharm Kle˛ka S.A. 31/12/08<br />

7281 Leponex Clozapinum Tablets 100 mg Novartis Pharma AG 31/05/04<br />

7282 Leponex Clozapinum Tablets 25 mg Novartis Pharma AG 31/05/04<br />

7283 Leptandra compositum Amp. Heel GmbH 31/12/08<br />

7284 Leptandra compositum Drops Heel GmbH 31/12/08<br />

7285 Leptoferm 5 Szczepionka przeciw<br />

leptospirozie dla s´wiń i<br />

bydła<br />

7286 Leptorabisin Szczepionka przeciw<br />

ws´ciekliz´nie i<br />

leptospirozie psów<br />

Suspension for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

7287 Lerivon Mianserinum Film-coated tablets 10 mg Organon N.V. —<br />

Kloosterstraat<br />

7288 Lerivon Mianserinum Film-coated tablets 30 mg Organon N.V. —<br />

Kloosterstraat<br />

7289 Lerivon Mianserinum Film-coated tablets 60 mg Organon N.V. —<br />

Kloosterstraat<br />

Pfizer 20/03/04<br />

Merial SAS 24/05/04<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

7290 Lescol Fluvastatinum Capsules 20 mg Novartis Pharma AG 29/05/05<br />

7291 Lescol Fluvastatinum Capsules 40 mg Novartis Pharma AG 29/05/05<br />

7292 Lescol XL Fluvastatinum Prolonged release<br />

tablets<br />

80 mg Novartis Pharma AG 21/06/06<br />

7293 Letin- Tran Jecoris aseli oleum Capsules, soft 260 mg Sanofi-Synthelabo Sp. z o.o. 30/04/05<br />

7295 Letizen Cetirizinum Film-coated tablets 10 mg Krka d.d., Novo mesto 15/03/06<br />

7294 Letizen Cetirizinum Oral solution 1 mg/ml KRKA d.d., Novo mesto 31/12/08<br />

7296 Letrox 25 Levothyroxinum<br />

natricum<br />

7297 Letrox 50 Levothyroxinum<br />

natricum<br />

7298 Letrox 100 Levothyroxinum<br />

natricum<br />

7299 Letrox 150 Levothyroxinum<br />

natricum<br />

7300 Leucat Szczepionka przeciw<br />

białaczce kotów<br />

Tablets 25 mcg Berlin-Chemie AG (Menarini<br />

Group)<br />

Tablets 50 mcg Berlin-Chemie AG (Menarini<br />

Group)<br />

Tablets 100 mcg Berlin-Chemie AG (Menarini<br />

Group)<br />

Tablets 150 mcg Berlin-Chemie AG (Menarini<br />

Group)<br />

Liquid for veterinary<br />

use<br />

30/06/04<br />

4/10/05<br />

30/06/04<br />

31/08/05<br />

Merial 2/03/04<br />

7301 Leucen Preparat złoz˙ony Ointment Tentan AG 23/11/05<br />

7302 Leucogen-Vet Szczepionka przeciw<br />

białaczce kotów<br />

Suspension for veterinary<br />

use<br />

7303 Leucomax Molgramostimum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

or for subcutaneous<br />

injection<br />

Virbac S.A. 25/04/04<br />

150 mcg Novartis Pharma AG 30/04/04


EN<br />

1070 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7304 Leucomax Molgramostimum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

or for subcutaneous<br />

injection<br />

7305 Leucomax Molgramostimum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

or for subcutaneous<br />

injection<br />

7306 Leucorifelin Szczepionka przeciw<br />

zakaz˙eniom kotów<br />

wywołanym przez<br />

wirus panleukopenii,<br />

herpeswirus i<br />

kaliciwirus dla kotów<br />

Lyophilisate + liquid for veterinary<br />

use<br />

7307 Leucostim Filgrastimum Solution for injection 0,3 mg /<br />

1,2 ml<br />

300 mcg Novartis Pharma AG 30/04/04<br />

400 mcg Novartis Pharma AG 30/04/04<br />

Merial 21/05/04<br />

BIOVENA PHARMA Sp.<br />

z.o.o.<br />

7308 Leucovarin Ca Calcii folinas Tablets 15 mg i 25 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

7309 Leucovorin — Teva Leucovorinum calcium +<br />

Calcii folinas<br />

7310 Leucovorin — Teva Leucovorinum calcium +<br />

Calcii folinas<br />

7311 Leucovorin — Teva Leucovorinum calcium +<br />

Calcii folinas<br />

7312 Leucovorin — Teva Leucovorinum calcium +<br />

Calcii folinas<br />

7313 Leucovorin — Teva Leucovorinum calcium +<br />

Calcii folinas<br />

7314 Leucovorin Ca Calcii folinas Powder for solution<br />

for injection<br />

7315 Leucovorin Ca Calcii folinas Powder for solution<br />

for injection<br />

Amp. 100 mg/10 ml Teva Pharmaceutical<br />

Industries<br />

Amp. 200 mg/20 ml Teva Pharmaceutical<br />

Industries<br />

Amp. 300 mg/30 ml Teva Pharmaceutical<br />

Industries<br />

Amp. 350 mg/35 ml Teva Pharmaceutical<br />

Industries<br />

Amp. 500 mg/50 ml Teva Pharmaceutical<br />

Industries<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

10 mg PLIVA — LACHEMA a.s. 31/05/04<br />

25 mg PLIVA — LACHEMA a.s. 31/05/04<br />

7316 LEUCOVORIN CA 10 Mg/Ml Calcii folinas Solution for injection 10 mg/ml PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

7317 Leucovorin Ca Lachema Acidum folinicum Solution for<br />

intramuscular and<br />

intravenous injection<br />

or for intravenous<br />

infusion<br />

31/12/08<br />

10 mg/ml Leciva a.s. 31/12/08<br />

7318 Leukeran Chlorambucilum Film-coated tablets 2 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

7319 Leukeran Chlorambucilum Film-coated tablets 5 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

7320 Leukocell 2 Inaktywowana<br />

szczepionka dla kotów<br />

przeciwko białaczce<br />

7321 Leuprorelin Leuprorelinum Subcutaneous<br />

injection<br />

Suspension for veterinary<br />

use<br />

7322 Levacide Lewamizolum Solution for veterinary<br />

use<br />

30/04/05<br />

30/04/05<br />

Pfizer Inc 22/05/07<br />

14 mg/2,8 ml Instytut Farmaceutyczny 31/12/08<br />

Norbrook Lab. Ltd. 8/11/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1071<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7323 Levamisol 1,5 % Lewamizolum Liquid for veterinary<br />

use<br />

7324 Levamisol 10 % Lewamizolum Liquid for veterinary<br />

use<br />

7325 Levamisol 5 % Lewamizolum Granules for veterinary<br />

use<br />

7326 Levamisole Injectio 7,5 % Lewamizolum Liquid for veterinary<br />

use<br />

7327 Levamizol 10 % Lewamizolum Powder for veterinary<br />

use<br />

7328 Levamizol 5 % Lewamizolum Powder for veterinary<br />

use<br />

7329 Levamizol 75 mg Lewamizolum Tablet for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Grodziaskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziaskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziaskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

21/05/04<br />

21/05/04<br />

21/05/04<br />

7330 Levico comp. Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

7331 Levico comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

7332 Levisticum Eye drops WALA-Heilmittel GmbH 24/05/07<br />

7333 Levonor Norepinephrinum Solution for<br />

intravenous infusion<br />

1 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/01/05<br />

7334 Levopraid Levosulpiridum Tablets 25 mg Ravizza Farmaceutici S.p.A. 31/12/08<br />

7335 Levopront Levodropropizinum Oral drops, solution 60 mg/ml Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

7336 Levopront Levodropropizinum Syrup 60 mg/10 ml Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

7337 Levoroxin Levothyroxinum<br />

natricum<br />

7338 Levoroxin Levothyroxinum<br />

natricum<br />

Tablets 100 mcg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Tablets 50 mcg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

7339 Levovist Galactosum Granules and solvent for suspension for<br />

intravenous injection<br />

7340 Lewamisan Lewamizolum Powder for veterinary<br />

use<br />

7341 Lewamisan dla gołe˛bi Lewamizolum Tablets for veterinary<br />

use<br />

7342 Lewamizol 4 % Lewamizolum Powder for veterinary<br />

use<br />

7343 Lewamizol 8 % Lewamizolum Powder for veterinary<br />

use<br />

15/11/06<br />

15/11/06<br />

1/08/05<br />

26/04/06<br />

Schering AG 31/12/07<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Grodziaskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

7344 Lexotan Bromazepamum Tablets 1.5 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

7345 Lexotan Bromazepamum Tablets 3 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

7346 Lexotan Bromazepamum Tablets 6 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

31/12/08<br />

21/05/04<br />

31/12/08<br />

31/12/08<br />

31/05/04<br />

31/05/04<br />

31/05/04<br />

7347 Lidocain Lidocainum Spray, solution 10 % Egis Pharmaceuticals Ltd. 21/03/07


EN<br />

1072 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7348 Lidodent Lidocainum Gingival gel 5 mg/g Marmir S.C. Zakład Produkcji<br />

Leków<br />

30/10/05<br />

7349 Lidogel o smaku mie˛towym Lidocainum Oromucosal gel 50 mg/g Septodont 30/11/04<br />

7350 Lidogel o smaku wis´niowym Lidocainum Oromucosal gel 50 mg/g Septodont 30/11/04<br />

7351 Lidokaina Lidocainum Gel 4 % Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

7352 Lidokainy chlorowodorek A.C.E.F., Włochy 31/12/08<br />

7353 Lidokainy chlorowodorek BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08<br />

7354 Lidokainy chlorowodorek Farm-Impex s.j., Gliwice 31/12/08<br />

7355 Lidokainy chlorowodorek Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

7356 Lidokainy chlorowodorek Pharma Cosmetic, Kraków 31/12/08<br />

7357 Lidokainy chlorowodorek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

7358 Lidoposterin Lidocainum Ointment 50 mg/g Dr Kade Pharmaceutical<br />

Fabrik<br />

7359 Lidoprim Cetylpirydinum<br />

chloridum + Lidocainum<br />

+ Mentholum<br />

Buccal tablets 1,5 mg +<br />

0,6 mg +<br />

3,0 mg<br />

Aflofarm Fabryka Leków Sp.<br />

z o.o.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

7360 Lien comp. granulki WALA-Heilmittel GmbH 31/08/05<br />

7361 Lien comp. inj. WALA-Heilmittel GmbH 31/08/05<br />

7362 Lifestream Preparat złoz˙ony Capsules, soft Sunrider Manufacturing L.P.,<br />

USA<br />

7363 Lifetonic Ginseng radix extractum<br />

spir. spissum<br />

7364 Lignadren Solution for injection 20 mg<br />

lidokainy HCL<br />

+ 0,01 mg<br />

wodorowinianu<br />

adrenaliny/<br />

1ml<br />

31/12/08<br />

Oral solution 32.4 mg/ml Phytopharm Kle˛ka S.A. 29/11/06<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

7365 Lignocain 2 % Lidocainum Solution for injection 20 mg/ml B. Braun Melsungen AG 21/09/05<br />

7366 Lignocainum Lidocainum Spray 100 mg/g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

7367 Lignocainum 5 % Grave Lidocainum Solution for injection 50 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

7368 Lignocainum hydrochloricum<br />

1%<br />

7369 Lignocainum hydrochloricum<br />

1%<br />

7373 Lignocainum hydrochloricum<br />

2%<br />

7370 Lignocainum Hydrochloricum<br />

2%<br />

7371 Lignocainum hydrochloricum<br />

2%<br />

Lidocainum Solution for injection 10 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Lidocainum Solution for injection 10 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Lidocainum Gel 20 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Lidocainum Solution for injection 20 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Lidocainum Solution for injection 20 mg/1ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05<br />

30/11/05<br />

30/10/05<br />

26/08/06<br />

30/11/05<br />

30/10/05<br />

26/08/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1073<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7372 Lignocainum hydrochloricum<br />

2%<br />

7374 Lignocainum hydrochloricum<br />

2 % c. noradrenalino<br />

0,00125 %<br />

Lidocainum Solution for injection 20 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Lidocainum +<br />

Norepinephrinum<br />

Solution for injection Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

7375 Limagin Cutaneous emulsion 25 mg/g Septoma — Farmaceutyczno-<br />

Chemiczna Spółdzielnia Pracy<br />

7376 Limagin Medicated powder 20 mg/g Septoma — Farmaceutyczno-<br />

Chemiczna Spółdzielnia Pracy<br />

7377 Linal Lini seminis maceratio<br />

basicum + Aluminii<br />

carbonas<br />

7378 Linamon Acidum ascorbicum<br />

(vit C)<br />

Oral suspension VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

30/11/05<br />

30/11/05<br />

31/01/06<br />

31/01/06<br />

30/01/05<br />

Film-coated tablets 0.1 g Krka d.d., Novo mesto 31/07/04<br />

7379 Lincocin Lincomycinum Capsules 500 mg Pharmacia N.V./S.A. 30/06/04<br />

7380 Lincocin Lincomycinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

7381 Lincocin 40 % Lincomycinum Powder for veterinary<br />

use<br />

7382 Lincocin forte Lincomicinum +<br />

Neomycinum +<br />

Methylprednisolonum<br />

7383 Lincocin Forte S Lincomycinum +<br />

Neomycinum<br />

Intramammary<br />

suspension<br />

300 mg/ml Pharmacia N.V./S.A. 30/06/04<br />

for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

7384 Lincomix 110 Lincomycinum Premix for veterinary<br />

use<br />

Pharmacia N.V./S.A. 12/03/06<br />

Pharmacia N.V./S.A. 31/12/08<br />

Pharmacia 31/12/08<br />

Pharmacia N.V./S.A. 28/03/06<br />

7385 Lincomycin Lincomycinum Capsules 0.25 g ZAO BRINSALOV A 31/12/06<br />

7386 Lincomycin — Spectinomycin<br />

— VMD pulvis<br />

7387 Lincomycine —<br />

Spectinomycine<br />

7388 Lincomycin-Spectinomycin-<br />

VMD injectablis<br />

Lincomycinum +<br />

Spektynomycinum<br />

Lincomycinum +<br />

Spektynomycinum<br />

Lincomycinum +<br />

Spektynomycinum<br />

Powder for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

7389 Lincomycin-VMD injectabilis Lincomycinum Solution for veterinary<br />

use<br />

7390 Linco-Spectin Lincomycinum +<br />

Spektynomycinum<br />

7391 Linco-Spectin 100 Lincomycinum +<br />

Spektynomycinum<br />

7392 Linco-Spectin Premix Lincomycinum +<br />

Spektynomycinum<br />

Solution for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Premix for veterinary<br />

use<br />

VMD 30/09/07<br />

Alfasan 21/05/04<br />

V.M.D. n.v./s.a. 2/01/06<br />

V.M.D. n.v./s.a. 30/01/06<br />

Pharmacia N.V./S.A. 11/03/04<br />

Pharmacia N.V./S.A. 30/12/04<br />

Pharmacia N.V./S.A. 17/03/04<br />

7393 Lindron Acidum alendronicum Tablets 10 mg Krka d.d., Novo mesto 17/01/07<br />

7394 Lindynette 20 Ethinyloestradiol,<br />

Gestodenum<br />

7395 Lindynette 30 Ethinyloestradiol,<br />

Gestodenum<br />

Film-coated tablets 20 mg +<br />

0,075 mg<br />

Film-coated tablets 30 mg +<br />

0,075 mg<br />

Gedeon Richter Ltd. 31/12/08<br />

Gedeon Richter Ltd. 31/12/08<br />

7396 Linia Preparat złoz˙ony Instant herbal tea Agropharm S.A. 6/06/07


EN<br />

1074 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7397 Linia Maxi Preparat złoz˙ony Instant herbal tea Agropharm S.A. 6/06/07<br />

7398 Linimentum Zinci Zinci oxydum Suspension Laboratorium Galenowe<br />

Katowice<br />

7399 Linimer S´luz z nasion lnu Capsules, soft 136 mg Specjalistyczne<br />

Przedsie˛biorstwo Rolno-<br />

Przetwórcze ‘GAL’ s.c.<br />

7400 Linkomicin 110 N Lincomycinum Premix for veterinary<br />

use<br />

7401 Linkomicin 44 N Lincomycinum Premix for veterinary<br />

use<br />

7402 Linkomicin F Lincomycinum +<br />

Nemicinum +<br />

Dexamethasonum<br />

7403 Linoeparol Allantoinum +<br />

Oenotherae oleum +<br />

Tocopherolum<br />

7404 Linoeparol Allantoinum +<br />

Oenotherae oleum +<br />

Tocopherolum<br />

Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

Lek Pharmaceutical and<br />

Chemical Company<br />

Lek Pharmaceutical and<br />

Chemical Company<br />

31/12/04<br />

31/12/08<br />

17/08/04<br />

15/10/04<br />

Lek Pharmaceutical 31/12/08<br />

Cream Agropharm S.A. 31/12/07<br />

Ointment Agropharm S.A. 31/12/07<br />

7405 Linoeparol Preparat złoz˙ony Liquid Agropharm S.A. 31/12/07<br />

7406 Linola Preparat złoz˙ony Cream Dr August Wolff GmbH &<br />

Co.<br />

7407 Linola Preparat złoz˙ony Ointment Dr August Wolff GmbH &<br />

Co.<br />

7408 Linola Bath additive Dr August Wolff GmbH &<br />

Co.<br />

7409 Linola D Lithanthracis Cream Dr August Wolff GmbH &<br />

Co.<br />

7410 Linola P Prednisolonum Cream 4 mg/g Dr August Wolff GmbH &<br />

Co.<br />

7411 Linola P Prednisolonum Ointment 4 mg/g Dr August Wolff GmbH &<br />

Co.<br />

7412 Linola P/N Neomycinum +<br />

Prednisolonum<br />

Cream Dr August Wolff GmbH &<br />

Co.<br />

7413 Linola® Gamma Evening primose oil Cream 200 mg/g Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

7414 Linola® Urea Urea Cream 120 mg/g Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

7415 Linoladiol Estradiolum Cream 0,01033 g/<br />

100 g<br />

Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

7418 Linomag Vitaminum F Coutanous liquid Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

7416 Linomag Vitaminum F Cream 200 mg/g Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

7417 Linomag Vitaminum F Ointment 200mg/g Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

7419 Lioton 1000 Heparinum Gel 1000 j.m./g A.Menarini Pharmaceutical<br />

Industries Group Ltd.<br />

23/11/05<br />

23/11/05<br />

31/07/04<br />

31/07/04<br />

30/04/05<br />

30/04/05<br />

31/07/04<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1075<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7420 Lipancrea 16 000 Amylasum + Lipasum +<br />

Proteasum<br />

7421 Lipancrea 8000 Amylasum + Lipasum +<br />

Proteasum<br />

Gastr-resistant<br />

capsules<br />

16000 j.Ph.Eur. Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Capsules 8000 j.Ph.Eur. Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/09/07<br />

8/02/06<br />

7422 Lipanor Ciprofibratum Capsules 100 mg Sanofi Winthrop-Gentilly 19/12/05<br />

7423 Lipanor Ciprofibratum Capsules 100 mg Sanofi-Synthelabo Sp. z o.o. 30/06/06<br />

7424 Lipanthyl Fenofibratum Capsules 100 mg Laboratoires Fournier S.A. 31/07/04<br />

7425 Lipanthyl 140M Fenofibratum Capsules 140 mg Laboratoires Fournier S.A. 31/05/05<br />

7426 Lipanthyl 200 M Fenofibratum Capsules 200 mg Laboratoires Fournier S.A. 31/07/04<br />

7427 Lipanthyl 267M Fenofibratum Capsules 267 mg Laboratoires Fournier S.A. 31/05/05<br />

7428 Lipanthyl 67M Fenofibratum Capsules 67 mg Laboratoires Fournier S.A. 31/05/05<br />

7429 Lipanthyl Supra 160 Fenofibratum Film-coated tablets 160 mg Laboratoires Fournier S.A. 11/10/06<br />

7430 Lipart Simvastatinum Film-coated tablets 10 mg Lek Polska Sp. z o.o. 14/02/07<br />

7431 Lipart Simvastatinum Film-coated tablets 20 mg Lek Polska Sp. z o.o. 14/02/07<br />

7432 Lipart Simvastatinum Film-coated tablets 40 mg Lek Polska Sp. z o.o. 14/02/07<br />

7433 Lipart Simvastatinum Film-coated tablets 5 mg Lek Polska Sp. z o.o. 14/02/07<br />

7434 Lipigem Gemfibrozilum Film-coated tablets 450 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

29/06/05<br />

7435 Lipobase Cream Yamanouchi Europe B.V. 31/12/06<br />

7436 Lipofibrat Fenofibratum Prolonged release<br />

capsules<br />

7437 Lipofundin 10 % N Preparat złoz˙ony Fatty emulsion for<br />

intravenous infusion<br />

7438 Lipofundin 20 % N Preparat złoz˙ony Fatty emulsion for<br />

intravenous infusion<br />

7439 Lipofundin MCT/LCT 10 % Preparat złoz˙ony Fatty emulsion for<br />

intravenous infusion<br />

7440 Lipofundin MCT/LCT 20 % Preparat złoz˙ony Fatty emulsion for<br />

intravenous infusion<br />

250 mg Pharmavit Kft. 31/05/05<br />

B. Braun Melsungen AG 31/07/04<br />

B. Braun Melsungen AG 31/07/04<br />

B. Braun Melsungen AG 31/07/04<br />

B. Braun Melsungen AG 31/07/04<br />

7441 Lipohep Heparinum Lyposome gel 300 j.m./g Medicom International s.r.o. 31/12/08<br />

7442 Lipohep Heparinum Lyposome gel 600 j.m./g Medicom International s.r.o. 31/12/08<br />

7443 Lipohep Heparinum Lyposome gel for<br />

cutaneous spray<br />

7444 Lipohep Forte Heparinum Lyposome gel for<br />

cutaneous spray<br />

7445 Lipolest® Plantaginis ovatae testa<br />

+ Guar gummi<br />

7446 Lipomal Tiliae inflorescentiae<br />

extractum siccum<br />

Granules for oral<br />

solution<br />

1.200 j.m./g Medicom International s.r.o. 31/12/08<br />

2.400 j.m./g Medicom International s.r.o. 31/12/08<br />

Sana Care Aps 31/12/08<br />

Syrup Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

31/12/08<br />

7447 Liposic Carbomerum Eye gel 2 mg/g Dr Gerhard Mann 31/12/08<br />

7448 Lipostat Pravastatinum Tablets 10 mg Bristol-Myers Squibb S.A.<br />

Epernon<br />

30/11/04


EN<br />

1076 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7449 Lipostat Pravastatinum Tablets 20 mg Bristol-Myers Squibb S.A.<br />

Epernon<br />

7450 Lipostat Pravastatinum Tablets 40 mg Bristol-Myers Squibb S.A.<br />

Epernon<br />

7451 Lipostatin Atrovastatinum Film-coated tablet 10 mg, 20 mg<br />

i 40 mg<br />

7452 Lipovenös 10 % PLR Emulsion for<br />

intravenous infusion<br />

7453 Lipovenös 20 % Phospolipidum essentiale<br />

+ Soyae oleum +<br />

Glycerolum<br />

Emulsion for<br />

intravenous infusion<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

7454 Lipozil Gemfibrozilum Film-coated tablets 450 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

7455 Liprox Lovastatinum Tablets 20 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

2/07/06<br />

21/03/07<br />

31/12/08<br />

31/07/04<br />

31/07/04<br />

31/05/05<br />

12/10/05<br />

7456 Lipryl 10 Lisinoprilum Tablets 10 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

7457 Lipryl 2,5 Lisinoprilum Tablets 2,5 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

7458 Lipryl 20 Lisinoprilum Tablets 20 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

7459 Lipryl 5 Lisinoprilum Tablets 5 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

7460 Lipryzyd Lizinoprilum +<br />

Hydrochlorothiazidum<br />

Tablets 10 mg + 12,<br />

5mg<br />

Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

7461 Lirebin Cisapridum Oral suspension 5 mg/5 ml Help S.A. Pharmaceuticals<br />

Attica<br />

31/12/08<br />

31/12/08<br />

7462 Lisdene Lisinoprilum Tablets 5 mg Biochemie GmbH 31/12/08<br />

7463 Lisdene Lisinoprilum Tablets 10 mg Biochemie GmbH 31/12/08<br />

7464 Lisdene Lisinoprilum Tablets 20 mg Biochemie GmbH 31/12/08<br />

7465 Lisinoratio 20 Lisinoprilum Tablets 20 mg ratiopharm GmbH 25/04/07<br />

7466 Lisinoratio 10 Lisinoprilum Tablets 10 mg ratiopharm GmbH 25/04/07<br />

7467 Lisinoratio 5 Lisinoprilum Tablets 5 mg ratiopharm GmbH 25/04/07<br />

7468 Lisiprol Lisinoprilum Tablets 10 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

7469 Lisiprol Lisinoprilum Tablets 20 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

7470 Lisiprol Lisinoprilum Tablets 5 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

7471 Lisiprol Hct Lisinoprilumj +<br />

Hydrochlorothiazidum<br />

7472 Lisiprol Hct Lisinoprilumj +<br />

Hydrochlorothiazidum<br />

7473 Lisonid Lisinoprilum +<br />

Hydrochlorothiazidum<br />

Film-coated tablets 20 mg +<br />

25 mg<br />

Film-coated tablets 20 mg +<br />

12,50 mg<br />

Tablets 10 mg +<br />

12,5 mg<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/08/05<br />

31/08/05<br />

31/08/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

7474 Listek senesu Sennae folium Bags 2.0 g PPH Biofluid 19/04/07<br />

7475 Lis´ć babki lancetowatej Herb Herbapol, Gdańsk 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1077<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7476 Lis´ć Babki lancetowatej Herb Herba Lux s.c. Zakład<br />

Przetwórstwa Zielarskiego<br />

30/10/05<br />

7477 Lis´ć Babki lancetowatej Herb Herbapol Lublin S.A. 30/10/05<br />

7478 Lis´ć Babki lancetowatej Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

7479 Lis´ć babki lancetowatej Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/10/05<br />

30/06/06<br />

7480 Lis´ć babki lancetowatej fix Herb Herbapol, Gdańsk 31/12/08<br />

7481 Lis´ć Babki zwyczajnej Herb Herbapol Lublin S.A. 31/01/05<br />

7482 Lis´ć bobrka Folium menyanthidis A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

19/07/07<br />

7483 Lis´ć bobrka Folium menyanthidis Herbapol Lublin 19/07/07<br />

7484 Lis´ć bobrka Folium menyanthidis Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7485 Lis´ć bobrka Folium menyanthidis Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

19/07/07<br />

19/07/07<br />

7486 Lis´ć bobrka 1 Folium menyanthidis Herbalux, Warszawa 25/08/06<br />

7487 Lis´ć borówki brusznicy Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7488 Lis´ć borówki brusznicy Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7489 Lis´ć borówki brusznicy 1 Zioła lecznicze Boguccy,<br />

Kraków<br />

7490 Lis´ć borówki brusznicy 1 i 2<br />

(Vitis fix, Brusznica fix)<br />

7491 Lis´ć Borówki czernicy -Folium<br />

Myrtilli<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

Herbapol Lublin 31/12/07<br />

Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

31/12/04<br />

7492 Lis´ć brusznicy 1 Herbalux, Warszawa 25/08/06<br />

7493 Lis´ć brusznicy 2 Phytopharm Dobrzyca 14/06/06<br />

7494 Lis´ć brzozy Folium betulae A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

19/07/07<br />

7495 Lis´ć brzozy Folium betulae Herbapol Lublin 19/07/07<br />

7496 Lis´ć brzozy Folium betulae Herbapol Pruszków 19/07/07<br />

7497 Lis´ć brzozy Folium betulae Varia, Katowice 19/07/07<br />

7498 Lis´ć brzozy Folium betulae Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7499 Lis´ć brzozy Folium betulae Zioła Lecznicze Boguccy,<br />

Kraków<br />

19/07/07<br />

19/07/07<br />

7500 Lis´ć brzozy 1 Folium betulae Herbapol Kraków 31/08/05<br />

7501 Lis´ć brzozy 1 i 2 Folium betulae Herbalux, Warszawa 26/03/06<br />

7502 Lis´ć brzozy 1 i 2 Folium betulae Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

26/03/06<br />

7503 Lis´ć Jez˙yny Herb Herbapol Lublin S.A. 30/10/05


EN<br />

1078 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7504 Lis´ć Jez˙yny Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

7505 Lis´ć jez˙yny Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/10/05<br />

30/06/06<br />

7506 Lis´ć jez˙yny fałdowanej Herbalux, Warszawa 14/03/06<br />

7507 Lis´ć maliny Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

7508 Lis´ć Maliny Herb Herbapol Lublin S.A. 31/01/05<br />

7509 Lis´ć Maliny -Folium Rubi idaei Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

7510 Lis´ć ma˛cznicy Uvae ursi folium A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

31/12/04<br />

19/07/07<br />

7511 Lis´ć ma˛cznicy Uvae ursi folium Herbalux, Warszawa 19/07/07<br />

7512 Lis´ć ma˛cznicy Uvae ursi folium Herbapol Lublin 19/07/07<br />

7513 Lis´ć ma˛cznicy Uvae ursi folium Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7514 Lis´ć ma˛cznicy Uvae ursi folium Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7515 Lis´ć ma˛cznicy Uvae ursi folium Zioła Lecznicze Boguccy,<br />

Kraków<br />

19/07/07<br />

19/07/07<br />

19/07/07<br />

7516 Lis´ć melisy Melissae folium Bags 2 g PPH Biofluid 14/03/07<br />

7517 Lis´ć melisy Melissae folium Herb A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

7518 Lis´ć melisy Melissae folium Herb in bags Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

7519 Lis´ć melisy Melissae folium Zakład Konfekcjonowania<br />

Ziół MALWA, Lubiszyn<br />

7520 Lis´ć melisy Melissae folium Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7521 Lis´ć melisy Melissae folium Zioła Lecznicze Boguccy,<br />

Kraków<br />

14/03/07<br />

14/03/07<br />

14/03/07<br />

14/03/07<br />

14/03/07<br />

7522 Lis´ć melisy (1 i 2) Melissae folium Herba Oskar, Wierzbówiec 31/12/08<br />

7523 Lis´ć melisy (1 i 2) Melissae folium Herbalux, Warszawa 31/12/08<br />

7524 Lis´ć melisy (1 i 2) Melissae folium Herbapol Pruszków 31/12/08<br />

7525 Lis´ć melisy (1 i 2) Melissae folium Zakład DARY NATURY,<br />

Grodzisk<br />

31/12/08<br />

7526 Lis´ć melisy 1 i 2 Melissae folium Herbapol Kraków 30/11/05<br />

7527 Lis´ć melisy 1 i 2 Melissae folium Herbapol Wrocław 30/11/05<br />

7528 Lis´ć melisy 1 i 2 Melissae folium Varia, Katowice 30/11/05<br />

7529 Lis´ć melisy 1 i 2 Melissae folium Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7530 Lis´ć melisy 1 i 2 Melissae folium Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

30/11/05<br />

30/11/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1079<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7531 Lis´ć melisy 1 i 2 (Melissa fix,<br />

Melisa fix)<br />

Melissae folium Herbapol Lublin 2/11/07<br />

7532 Lis´ć melisy 2 Melissae folium Phytopharm Dobrzyca 19/11/06<br />

7533 Lis´ć Melisy fix -Folium<br />

Melissae<br />

Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

7534 Lis´ć Melisy -Folium Melissae Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

31/12/04<br />

31/12/04<br />

7535 Lis´ć melisy Melissa Tea Melissae folium Elanda, Rozprza 31/10/05<br />

7536 Lis´ć mie˛ty Menthae Piperitae<br />

Folium<br />

7537 Lis´ć mie˛ty pieprzowej Menthae Piperitae<br />

Folium<br />

7538 Lis´ć mie˛ty pieprzowej Menthae Piperitae<br />

Folium<br />

7539 Lis´ć mie˛ty pieprzowej Menthae Piperitae<br />

Folium<br />

7540 Lis´ć mie˛ty pieprzowej Menthae Piperitae<br />

Folium<br />

7541 Lis´ć mie˛ty pieprzowej Menthae Piperitae<br />

Folium<br />

7542 Lis´ć mie˛ty pieprzowej Menthae Piperitae<br />

Folium<br />

7543 Lis´ć mie˛ty pieprzowej (1 i 2) Menthae Piperitae<br />

Folium<br />

7544 Lis´ć mie˛ty pieprzowej (1 i 2) Menthae Piperitae<br />

Folium<br />

7545 Lis´ć mie˛ty pieprzowej (2) Menthae Piperitae<br />

Folium<br />

7546 Lis´ć mie˛ty pieprzowej 1 Menthae Piperitae<br />

Folium<br />

7547 Lis´ć mie˛ty pieprzowej 1 i 2 Menthae Piperitae<br />

Folium<br />

7548 Lis´ć mie˛ty pieprzowej 1 i 2 Menthae Piperitae<br />

Folium<br />

7549 Lis´ć mie˛ty pieprzowej 1 i 2 Menthae Piperitae<br />

Folium<br />

7550 Lis´ć mie˛ty pieprzowej 1 i 2 Menthae Piperitae<br />

Folium<br />

7551 Lis´ć mie˛ty pieprzowej 1 i 2 Menthae Piperitae<br />

Folium<br />

7552 Lis´ć mie˛ty pieprzowej 1 i 2<br />

(Mentha fix, Mie˛ta fix)<br />

Menthae Piperitae<br />

Folium<br />

7553 Lis´ć mie˛ty pieprzowej 2 Menthae Piperitae<br />

Folium<br />

Herbapol Łódz´ 31/12/07<br />

Bags 2 g PPH Biofluid 14/03/07<br />

Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

14/03/07<br />

Jukunda Naturarzneimittel 14/03/07<br />

Zakład Konfekcjonowania<br />

Ziół MALWA, Lubiszyn<br />

Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

Zioła Lecznicze Boguccy,<br />

Kraków<br />

14/03/07<br />

14/03/07<br />

14/03/07<br />

Herbalux, Warszawa 31/12/08<br />

Zakład DARY NATURY,<br />

Grodzisk<br />

31/12/08<br />

Elanda, Rozprza 30/04/06<br />

Elanda, Rozprza 31/08/05<br />

Herba Oskar, Wierzbówiec 31/12/08<br />

Herbapol Kraków 31/12/08<br />

Herbapol Wrocław 31/12/08<br />

Varia, Katowice 31/12/08<br />

Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

31/12/08<br />

Herbapol Lublin 2/11/07<br />

Phytopharm Dobrzyca 31/12/06


EN<br />

1080 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7554 Lis´ć mie˛ty pieprzowej 2 Menthae Piperitae<br />

Folium<br />

Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7555 Lis´ć Mie˛ty pieprzowej fix Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

7556 Lis´ć Mie˛ty pieprzowej -Folium<br />

Menthae<br />

7557 Lis´ć mie˛ty pierzowej (1 i 2) Menthae Piperitae<br />

Folium<br />

Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

31/12/06<br />

31/12/04<br />

31/12/04<br />

Herbapol Pruszków 31/07/05<br />

7558 Lis´ć ortosyfonu Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

7559 Lis´ć Ortosyfonu groniastego Herb Herba Studio Ms´cisz i<br />

Wspólnicy Spółka Jawna<br />

7560 Lis´ć Orzecha Włoskiego Juglandis folium Herb Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

31/01/05<br />

30/10/05<br />

11/03/06<br />

7561 Lis´ć orzecha włoskiego Herb Bogucki, Kraków 31/12/08<br />

7562 Lis´ć orzecha włoskiego Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

7563 Lis´ć Orzecha Włoskiego Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

31/12/08<br />

30/10/05<br />

7564 Lis´ć Orzecha Włoskiego Herb Herbapol Lublin S.A. 30/10/05<br />

7565 Lis´ć Orzecha Włoskiego Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

30/10/05<br />

7566 Lis´ć podbiału Herbalux, Warszawa 31/12/08<br />

7567 Lis´ć podbiału Herbapol Lublin 31/12/08<br />

7568 Lis´ć podbiału Herbapol Wrocław 31/12/08<br />

7569 Lis´ć podbiału Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7570 Lis´ć podbiału Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7571 Lis´ć pokrzywy Urticae folium Herb A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

7572 Lis´ć pokrzywy Urticae folium Herb in bags Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

31/12/08<br />

31/12/08<br />

19/07/07<br />

30/10/05<br />

7573 Lis´ć pokrzywy Herb Herbaflos, Płońsk 30/10/05<br />

7574 Lis´ć Pokrzywy Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/10/05<br />

7575 Lis´ć Pokrzywy Herb Herbapol Lublin S.A. 30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1081<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7576 Lis´ć Pokrzywy Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

7577 Lis´ć Pokrzywy Herb Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

7578 Lis´ć Pokrzywy Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

7579 Lis´ć Pokrzywy Herb Zioła Lecznicze — Boguccy<br />

s.c.<br />

7580 Lis´ć Pokrzywy Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

7581 Lis´ć Pokrzywy Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

7582 Lis´ć pokrzywy Herb Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

19/07/07<br />

30/10/05<br />

30/10/05<br />

7583 Lis´ć pokrzywy 1 i 2 Urticae folium Herbapol Kraków 19/12/06<br />

7584 Lis´ć pokrzywy fix Herb Herbapol, Bydgoszcz 30/10/05<br />

7585 Lis´ć pokrzywy fix Herb Herbapol, Bydgoszcz 30/10/05<br />

7586 Lis´ć Pokrzywy fix Herb Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

7587 Lis´ć Pokrzywy fix Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

7588 Lis´ć Porzeczki Czarnej Ribei nigri folium Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

7589 Lis´ć porzeczki czarnej Ribis nigri folium Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

27/09/06<br />

7590 Lis´ć porzeczki czarnej Ribis nigri folium Herb HERBAPOL BIAŁYSTOK S.A. 31/12/08<br />

7591 Lis´ć poziomki a Herb HERBAPOL BIAŁYSTOK S.A. 31/12/08<br />

7592 Lis´ć prawos´lazu Herbapol Lublin 31/12/07<br />

7593 Lis´ć prawos´lazu Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/12/07<br />

7594 Lis´ć prawos´lazu 1 Herbalux, Warszawa 25/08/06<br />

7595 Lis´ć Prawos´lazu -Folium<br />

Althaeae<br />

Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

31/12/04<br />

7596 Lis´ć rozmarynu Herbapol Lublin 31/12/07<br />

7597 Lis´ć rozmarynu Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7598 Lis´ć rozmarynu Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/12/07<br />

31/12/07<br />

7599 Lis´ć rozmarynu 1 Herbalux, Warszawa 25/08/06<br />

7600 Lis´ć rozmarynu 1 Zioła Lecznicze Boguccy,<br />

Kraków<br />

7601 Lis´ć senesu Sennae folium Aflofarm Fabryka Leków,<br />

Ksawerów<br />

25/08/06<br />

14/06/05


EN<br />

1082 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7602 Lis´ć senesu Sennae folium Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14/06/05<br />

7603 Lis´ć senesu (1 i 2) Sennae folium Herba Oskar, Wierzbówiec 31/12/08<br />

7604 Lis´ć senesu 1 Sennae folium Zioła Lecznicze Boguccy,<br />

Kraków<br />

30/11/05<br />

7605 Lis´ć senesu 1 i 2 Sennae folium Herbalux, Warszawa 16/06/06<br />

7606 Lis´ć senesu 1 i 2 Sennae folium Herbapol Kraków 16/06/06<br />

7607 Lis´ć senesu 1 i 2 Sennae folium Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7608 Lis´ć senesu 1 i 2 (Senes fix;<br />

Sennae fix)<br />

16/06/06<br />

Sennae folium Herbapol Lublin 17/01/06<br />

7609 Lis´ć senesu 2 Sennae folium Phytopharm Dobrzyca 19/11/06<br />

7610 Lis´ć senesu 2 Sennae folium Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7611 Lis´ć Senesu -Folium Sennae Sennae folium Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

19/11/06<br />

31/12/04<br />

7612 Lis´ć senesu kaps. 300 mg Sennae folium Phytopharm Kle˛ka S.A. 31/12/05<br />

7613 Lis´ć senesu -lis´cie<br />

rozdrobnione<br />

Sennae folium Elanda, Rozprza 24/01/06<br />

7614 Lis´ć szałwii Folium salviae Herb in bags Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

7615 Lis´ć szałwii Folium salviae Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

30/08/07<br />

30/08/07<br />

7616 Lis´ć szałwii (1 i 2) Folium salviae Herba Oskar, Wierzbówiec 31/12/08<br />

7617 Lis´ć szałwii (1 i 2) Folium salviae Herbalux, Warszawa 31/12/08<br />

7618 Lis´ć szałwii (1 i 2) Folium salviae Herbapol Pruszków 31/12/08<br />

7619 Lis´ć szałwii (1 i 2) Folium salviae Zakład DARY NATURY,<br />

Grodzisk<br />

31/12/08<br />

7620 Lis´ć szałwii (2) Folium salviae Elanda, Rozprza 30/04/06<br />

7621 Lis´ć szałwii 1 Folium salviae Zioła Lecznicze Boguccy,<br />

Kraków<br />

15/02/05<br />

7622 Lis´ć szałwii 1 i 2 Folium salviae Herbapol Kraków 31/08/05<br />

7623 Lis´ć szałwii 1 i 2 Folium salviae Herbapol Wrocław 31/08/05<br />

7624 Lis´ć szałwii 1 i 2 Folium salviae Varia, Katowice 31/08/05<br />

7625 Lis´ć szałwii 1 i 2 Folium salviae Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

7626 Lis´ć szałwii 1 i 2 (Salvia fix,<br />

Szałwia fix)<br />

31/08/05<br />

Folium salviae Herbapol Lublin 2/11/07<br />

7627 Lis´ć szałwii 2 Folium salviae Vitax, Dobrzyca 24/04/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1083<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7628 Lis´ć szałwii 2 Folium salviae Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

7629 Lis´ć Szałwii fix -Folium Salviae Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

7630 Lis´ć Szałwii -Folium Salviae Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

7631 Lithium Carbonicum Lithium Tablets 250 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

24/04/07<br />

31/12/04<br />

31/12/04<br />

31/12/05<br />

7632 Lithiumeel Tablets Heel GmbH 31/12/08<br />

7633 Litocid Kalii citras Modified release<br />

tablets<br />

7634 Litter Guard LT-C inaktywowana<br />

szczepionka dla<br />

wysokopros´nych s´wiń<br />

Suspension for veterinary<br />

use<br />

680 mg Labor Farmaceutyczno-<br />

Chemiczna Spółdzielnia Pracy<br />

17/01/07<br />

Pfizer 31/12/08<br />

7635 Liv 52 Tablets The Himalaya Drug Co. 31/12/04<br />

7636 Livacox Q Atenuowana<br />

szczepionka dla kur<br />

przeciw kokcydiozie<br />

7637 Livacox T Szczepionka dla kur<br />

przeciw kokcydiozie<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

7638 Livial Tibolonum Tablets 2.5 mg Organon N.V. —<br />

Kloosterstraat<br />

Biopharm 20/07/06<br />

Biopharm 18/09/05<br />

30/06/04<br />

7639 Locacid Tretinoinum Cream 0,05 % Pierre Fabre Dermatologie 26/09/07<br />

7640 Locatop Desonidum Cream 1 mg/g Pierre Fabre Dermatologie 5/07/06<br />

7641 Loceryl Amorolfinum Medicated nail lacquer 50 mg/ml Lab. Galderma S.A. 31/03/05<br />

7642 Locoid Hydrocortisoni butyras Cream 1 mg/g Yamanouchi Europe B.V. 31/07/04<br />

7643 Locoid Hydrocortisoni butyras Cuatneous solution 1 mg/ml Yamanouchi Europe B.V. 31/07/04<br />

7644 Locoid Crelo Hydrocortisoni butyras Emulsion 1 mg/g Yamanouchi Europe B.V. 12/12/06<br />

7645 Locoid Lipocream Hydrocortisoni butyras Cream 1 mg/g Yamanouchi Europe B.V. 31/07/04<br />

7646 Lodronat Acidum clodronicum Solution for<br />

intravenous infusion<br />

30 mg/1ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

7647 Loette Wyeth — Lederle Pharma<br />

GmbH<br />

7648 Lofenalac Dieta w fenyloketonurii Powder Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

7649 Lofenalac Dieta w fenyloketonurii Powder for solution Mead Johnson Nutritional<br />

Group<br />

7650 Logest Ethinylestradiolum +<br />

Gestodenum<br />

7651 Logimax Felodipinum +<br />

Metoprololum<br />

7652 Logimax Felodipinum +<br />

Metoprololum<br />

31/05/04<br />

31/12/08<br />

31/12/05<br />

30/06/04<br />

Film-coated tablets Schering AG 31/07/04<br />

Prolonged release<br />

tablets<br />

Prolonged release<br />

tablets<br />

5mg + 47,5mg AstraZeneca AB 17/01/07<br />

10mg + 95mg AstraZeneca AB 17/01/07<br />

7653 Lokomitiv Dla Dzieci Wycia˛g z kła˛cza imbiru Syrup Aflofarm 31/12/08


EN<br />

1084 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7654 Lokren 20 Betaxololum Film-coated tablets 20 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

30/04/04<br />

7655 Lomac 20 Omeprazolum Capsules 20 mg Cipla Ltd. 31/12/08<br />

7656 Lomaherpan cream Cream Lomapharm, Rudolf<br />

Lohmann GmbH Kb, Niemcy<br />

7657 Lomexin Fenticonazelum Foam 2 % Medana Pharma TERPOL<br />

Group S.A.<br />

7658 Lomexin Fenticonazelum Shampoo 2 % Medana Pharma TERPOL<br />

Group S.A.<br />

7660 Lomexin Fenticonazoli nitras Coutanous liquid 20 mg/g Recordati Industria Chimica e<br />

Farmaceutica Sp.A<br />

7659 Lomexin Fenticonazoli nitras Cream 20 mg/g Recordati Industria Chimica e<br />

Farmaceutica Sp.A<br />

7661 Lomexin Fenticonazoli nitras Medicated powder 20 mg/g Recordati Industria Chimica e<br />

Farmaceutica Sp.A<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

12/10/05<br />

12/10/05<br />

12/10/05<br />

7662 Lomir SRO Isradipinum Capsules 2.5 mg Novartis Pharma AG 30/01/05<br />

7663 Lomir SRO Isradipinum Capsules 5 mg Novartis Pharma AG 31/12/04<br />

7664 Lomusol Acidum cromoglicicum Nasal spray, solution 2.6 mg/dawke˛ Rhône-Poulenc Rorer Fisons<br />

Ltd.<br />

7665 Lomusol Forte Acidum cromoglicicum Nasal spray 4 % (40 mg/ml) Rhône-Poulenc Rorer Fisons<br />

Ltd.<br />

7666 Lomustine Medac Lomustinum Capsules, hard 40 mg medac Gesellschaft für<br />

klinische Spezialpräparate<br />

mbH<br />

30/06/04<br />

31/05/04<br />

31/12/08<br />

7667 Lomustinum Lomustinum Tablets 40 mg Instytut Farmaceutyczny 31/12/07<br />

7668 Longamox Amoxiciclinum Suspension for veterinary<br />

use<br />

7669 Longicillin Benzynopenicylina<br />

benzatynowa,<br />

benzylopenicylina<br />

prokainowa<br />

Suspension for veterinary<br />

use<br />

Biowet Gorzów 31/12/08<br />

Chassot AG 31/12/08<br />

7670 Loniten Minoxidilum Tablets 10 mg Pharmacia & Upjohn Ltd. 30/06/04<br />

7671 Loniten Minoxidilum Tablets 5 mg Pharmacia & Upjohn Ltd. 30/06/04<br />

7672 Lopatol 100 Nitroskanat<br />

mikronizowany ,<br />

7673 Lopatol 500 Nitroskanat<br />

mikronizowany<br />

Tablet for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Novartis Produkte Inc. 19/01/04<br />

Novartis Produkte Inc. 19/01/04<br />

7674 Loperamid Loperamidum Tablets 2 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

7675 Lorafen Lorazepamum Coated tablets 1 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

7676 Lorafen Lorazepamum Coated tablets 2.5 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/10/05<br />

31/12/05<br />

31/12/05<br />

7677 Loraratio Loratadinum Tablets 10 mg ratiopharm GmbH 31/12/08<br />

7678 Loratadin — 10 — Sl Loratadinum Tablets 10 mg Slovakofarma a.s. 31/12/08<br />

7679 Loratadyna Loratadinum Syrup 10 mg /10 ml Aflofarm 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1085<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7680 Loratadyna Loratadinum Tablets 10 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

31/12/08<br />

7681 Loratadyna Loratadinum Tablets 10 mg Aflofarm 31/12/08<br />

7682 Loratadyna Loratadinum Tablets 10 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

7683 Loratadyna 1 mg/1 ml Loratidinum Syrup 1 mg / 1 ml Farmaceutyczna Spółdzielnia<br />

Pracy ‘GALENA’<br />

7684 Loratan Loratadinum Capsules, soft 10 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

7685 Loratan Loratadinum Syrup 5 mg/5 ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

7686 Loratine Loratadinum Syrup 5 mg/5 ml Medana Pharma Terpol<br />

Group S.A.<br />

7687 Loratine Loratadinum Tablets 10 mg Medana Pharma Terpol<br />

Group S.A.<br />

31/12/08<br />

31/12/08<br />

25/10/06<br />

24/08/05<br />

31/12/08<br />

31/12/08<br />

7688 Loratio Loratadinum Syrup 1 mg/ml ratiopharm GmbH 31/12/08<br />

7689 Loravin Loratadinum Film-coated tablets 10 mg IVAX PHARMA POLAND Sp.<br />

z o.o.<br />

7690 Lorinden A Acidum salicylicum +<br />

Flumetasonum<br />

7691 Lorinden C Clioquinolum +<br />

Flumetasonum<br />

7692 Lorinden C Clioquinolum +<br />

Flumetasonum<br />

Ointment (30mg +<br />

0,2mg)/g<br />

Cream (30mg +<br />

0,2mg)/g<br />

Ointment (30mg +<br />

0,2mg)/g<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

7693 Lorinden lotio Flumetasonum Cutaneous emulsion 200mcg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

7694 Lorinden N Flumetasonum +<br />

Neomycinum<br />

7695 Lorinden T Acidum salicylicum +<br />

Flumetasonum + Pix<br />

litanthracis<br />

Cream (0,2mg +<br />

5mg)/g<br />

Ointment (10mg +<br />

0,2mg +<br />

15mg)/g<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/12/08<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

7696 Lorista Losartanum Film-coated tablets 50 mg Krka d.d., Novo mesto 31/08/05<br />

7697 Loropoz Loratadinum Tablets 10 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/12/08<br />

7698 Losacor Losartanum Film-coated tablets 50 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

7699 Losartan + Hct Tablets PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

7700 Losec Omeprazolum Capsules 20 mg AstraZeneca AB 30/06/04<br />

7702 Losec Omeprazolum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

7701 Losec Omeprazolum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

40 mg AstraZeneca AB 31/07/04<br />

40 mg AstraZeneca AB 30/09/04<br />

7703 Losec 10 Omeprazolum Capsules 10 mg AstraZeneca AB 31/12/07<br />

7704 Losec MUPS Omeprazolum Film-coated,<br />

gastro-resistant tablets<br />

10 mg AstraZeneca AB 23/11/05


EN<br />

1086 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7705 Losec MUPS Omeprazolum Film-coated,<br />

gastro-resistant tablets<br />

7706 Losec MUPS Omeprazolum Film-coated,<br />

gastro-resistant tablets<br />

20 mg AstraZeneca AB 23/11/05<br />

40 mg AstraZeneca AB 23/11/05<br />

7707 LOSEPRAZOL 20 mg Omeprazolum Capsules 20 mg Liconsa S.A. 31/12/08<br />

7708 Lotensin Benazeprilum Film-coated tablets 10 mg Novartis Pharma AG 31/05/04<br />

7709 Lotensin Benazeprilum Film-coated tablets 20 mg Novartis Pharma AG 31/05/04<br />

7710 Lotensin Benazeprilum Film-coated tablets 5 mg Novartis Pharma AG 31/05/04<br />

7711 Lotensin HCT Benazeprilum +<br />

Hydrochlorothiazidum<br />

7712 Lotensin HCT Benazeprilum +<br />

Hydrochlorothiazidum<br />

7713 Lotensin HCT Benazeprilum +<br />

Hydrochlorothiazidum<br />

7714 Lotriderm Betamethasonum +<br />

Clotrimazolum<br />

Film-coated tablets 5mg + 6,25mg Novartis Pharma AG 31/12/04<br />

Film-coated tablets 10mg +<br />

12,5mg<br />

Novartis Pharma AG 31/12/04<br />

Film-coated tablets 20mg + 25mg Novartis Pharma AG 31/12/04<br />

Cream Schering-Plough Labo N.V. 31/03/04<br />

7715 Lovastatinum Lovastatinum Tablets 20 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

30/04/06<br />

7716 Lovastatinum Lovastatinum Tablets 20 mg Aflofarm 31/12/08<br />

7717 Lovastatinum 10 Lovastatinum Tablets 10 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

7718 Lovastatinum 40 Lovastatinum Tablets 40 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

7719 Lovasterol Lovastatinum Tablets 10 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

7720 Lovasterol Lovastatinum Tablets 20 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

7721 Lovasterol Lovastatinum Tablets 40 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

7722 Lovastin Lovastatinum Tablets 20 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

7723 Loveston Ethinylestradiolum +<br />

Norethisteronum<br />

Tablets 0,05mg +<br />

0,5mg<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

7724 Lowastatyna Lovastatinum Tablets 10 mg P.P.W. ‘EURO — LEK’,<br />

Sosnowiec<br />

7725 Lowastatyna Lovastatinum Tablets 20 mg P.P.W. ‘EURO — LEK’,<br />

Sosnowiec<br />

31/12/08<br />

31/12/08<br />

29/06/05<br />

29/06/05<br />

29/06/05<br />

31/12/08<br />

30/11/05<br />

30/09/07<br />

30/09/07<br />

7726 Loxon Minoxidilum Coutanous liquid 20 mg/ml Sanofi-Synthelabo Sp. z o.o. 31/12/05<br />

7727 Loxon 5 % Minoxidilum Coutanous liquid 50 mg/ml Sanofi-Synthelabo Sp. z o.o. 31/08/05<br />

7728 Lozap 50 Losartanum kalicum Film-coated tablets 50 mg Leciva a.s. 31/12/08<br />

7729 L-Spartakon Lewamizolum Tablet for veterinary<br />

use<br />

7730 Lubex Dinatrii undecylyloxyethylamidosulfosuccinas<br />

Janssen 10/02/04<br />

Cutaneous emulsion 30 mcg/g Permamed Laboratories Ltd. 30/09/04<br />

7731 Lubexyl Benzoylis peroxydum Cutaneous suspension 40 mg/g Permamed Laboratories Ltd. 30/09/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1087<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7732 Lucetam Piracetamum Film-coated tablets 1200 mg Egis Pharmaceuticals Ltd. 24/05/06<br />

7733 Lucetam Piracetamum Film-coated tablets 400 mg Egis Pharmaceuticals Ltd. 15/03/06<br />

7734 Lucetam Piracetamum Film-coated tablets 800 mg Egis Pharmaceuticals Ltd. 15/03/06<br />

7735 LUCETAM Injection Piracetamum Solution for injection 200 mg/ml Egis Pharmaceuticals Ltd. 31/12/08<br />

7736 Lucrin Depot Leuprorelinum Microgranules and<br />

solvent for suspension<br />

for intramuscular or<br />

subcutaneous<br />

injection<br />

7737 Lucrin Depot Leuprorelinum Microgranules and<br />

solvent for suspension<br />

for intramuscular or<br />

subcutaneous<br />

injection<br />

3.75 mg Abbott Laboratories S.A. 23/10/06<br />

11.25 mg Abbott Laboratories S.A. 30/06/04<br />

7739 Ludiomil Maprotilinum Film-coated tablets 25 mg Novartis Pharma AG 30/04/04<br />

7740 Ludiomil Maprotilinum Film-coated tablets 75 mg Novartis Pharma AG 30/04/04<br />

7738 Ludiomil Maprotilinum Solution for injection 5 mg/ml Novartis Pharma AG 30/04/04<br />

7741 Luffa Compositum-Heel Tablets Heel GmbH 31/07/05<br />

7742 Luffa-Comp. — Heel Drops Heel GmbH 31/12/08<br />

7743 Luivac Tablets 3 mg lizatu<br />

bakteryjnego<br />

Sankyo Pharma GmbH —<br />

München<br />

7744 Lumbolin Ointment Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

7745 Lumewal (poprzednia nazwa:<br />

ziołowe krople uspokajaja˛ce)<br />

Valerianae radix tinctura Oral solution Farmaceutyczne<br />

Przedsie˛biorstwo Prod. —<br />

Anal. — Handl. ‘PROLAB’<br />

s.c., Nakło<br />

23/04/04<br />

31/01/06<br />

31/12/08<br />

7746 Lumigan Bimatoprostum Eye drops, solution 0,3 mg/ml Allergan Pharmaceuticals Ltd. 31/12/08<br />

7748 Luminalum Phenobarbitalum Solution for injection 200 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

7747 Luminalum Phenobarbitalum Suppository 15 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

7749 Luminalum Phenobarbitalum Tablets 0.015 g Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

7750 Luminalum Phenobarbitalum Tablets 100 mg Farmaceutyczno —<br />

Chemiczna Spółdzielnia Pracy<br />

Galenus<br />

7751 Luminalum Phenobarbitalum Tablets 100 mg Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

7752 Lunella Medroxyprogesteronum<br />

+ Estradiolum<br />

Suspension for<br />

injection<br />

30/11/05<br />

31/12/05<br />

30/11/05<br />

31/01/06<br />

30/09/05<br />

PHARMACIA & UPJOHN 31/12/08<br />

7753 Lupulina Lupulinum Capsules 250 mg Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

24/09/07<br />

7754 Lupulina Lupulinum Capsules 250 mg Herbapol Kraków 24/02/05


EN<br />

1088 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7755 Lusopress Nitrendipinum Tablets 20 mg Instituto Lusofarmaco D'Italia<br />

SpA<br />

31/12/08<br />

7756 Luteina Progesteronum Vaginal tablets 50 mg Adamed Sp. z o.o. 4/07/07<br />

7757 Luteina 50 Progesteronum Sublingual tablets 50 mg Adamed Sp. z o.o. 31/01/06<br />

7758 Lutenyl Nomegestrolum Tablets 5 mg Theramex Laboratory 24/05/06<br />

7759 Luteosyl d-kloprostenol Solution for veterinary<br />

use<br />

Laboratorios Syva 31/12/08<br />

7760 Lutrol Meloxicamum Suppository 15 mg Abbott S.p.A 31/01/05<br />

7761 Lutrol Meloxicamum Tablets 15 mg Abbott S.p.A 31/01/05<br />

7762 Lutrol Meloxicamum Tablets 7.5 mg Abbott S.p.A 31/01/05<br />

7763 Luveris 75 Lutropinum — alfa Powder and solvent<br />

for solution for<br />

injection<br />

75 IU Serono Europe Limited 31/12/08<br />

7764 Lycopodium similiaplex krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

7765 Lydium — KLP 2 mg Dimer lizozymu Solution for veterinary<br />

use<br />

7766 Lydium — KLP 5 mg Dimer lizozymu Solution for veterinary<br />

use<br />

30/11/05<br />

Nika Health Products 15/12/04<br />

Nika Health Products 15/12/04<br />

7767 Lymphdiaral Mas´ć Pascoe Pharmaceutische<br />

Preparate GmbH<br />

7768 Lymphoglobuline Antilymphocyte<br />

immunoglobulin (horse)<br />

Solution for<br />

intravenous infusion<br />

30/11/05<br />

4250 j.m. IMTIX SANGSTAT, Lyon 30/04/04<br />

7769 Lymphomyosot Tablets Heel GmbH 30/06/07<br />

7770 Lymphomyosot N Amp. Heel GmbH 30/06/07<br />

7771 Lymphomyosot N Drops Heel GmbH 30/06/07<br />

7772 Lymphozil Echinaceae pallidae radix<br />

extr. sicc.<br />

Buccal tablets 30 mg Cesra — Arzneimittel GmbH<br />

& Co. KG<br />

7773 Lymphozil Preparat złoz˙ony Tablets Julius Redel CESRA —<br />

Arzneimittelfabrik GmbH<br />

7774 Lymphozil forte Preparat złoz˙ony Tablets Julius Redel CESRA —<br />

Arzneimittelfabrik GmbH<br />

7775 Lyomarex Szczepionka przeciw<br />

chorobie Mareka<br />

7776 Lysvulpen szczepionka przeciw<br />

ws´ciekliz´nie dla lisów<br />

wolno z˙yja˛cych<br />

7777 M+Pac szczepionka dla s´wiń<br />

do czynnego<br />

uodparniania<br />

klinicznie zdrowych<br />

s´wiń w celu obniz˙enia<br />

upadków oraz<br />

zmniejszenia nasilenia<br />

objawów zwia˛zanych<br />

z mykoplazmowym<br />

zapaleniem płuc<br />

7779 Maalox Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Blister form of<br />

vaccine in bait<br />

substance<br />

for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Oral suspension (35mg +<br />

40mg)/ml<br />

31/12/08<br />

30/04/04<br />

30/04/04<br />

Merial SAS 31/12/08<br />

Bioveta a.s. 31/12/08<br />

Schering Plough 31/12/08<br />

Rhône-Poulenc Rorer<br />

Teraplix<br />

31/07/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1089<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7778 Maalox Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

7780 Maasol — Zestaw do<br />

sporza˛dzania makroagregatów<br />

ludzkiej albuminy znaczonych<br />

technetem 99m<br />

Tablets 400mg +<br />

400mg<br />

Powder for<br />

suspension for<br />

intravenous injection<br />

7781 MabCampath Alemtuzumab Concentrate for<br />

solution for infusion<br />

7782 Mabthera Rituximabum Concentrate for<br />

solution for<br />

intravenous infusion<br />

Rhône-Poulenc Rorer<br />

Teraplix<br />

17.5 mg Nycomed Amershan Sorin<br />

S.R.L.<br />

10 mg/ml Ilex Pharmaceuticals Ltd. The<br />

Surrey Research Park<br />

10 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

7783 Mabuson Buspironum Tablets 10 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

7784 Mabuson Buspironum Tablets 5 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

7785 Macdafen 0,5 Ifosfamidum Lyophilisate for<br />

solution for injection<br />

7786 Macdafen 1 Ifosfamidum Lyophilisate for<br />

solution for injection<br />

7787 Macdafen 2 Ifosfamidum Lyophilisate for<br />

solution for injection<br />

31/07/04<br />

9/08/06<br />

7/03/07<br />

31/07/04<br />

31/03/07<br />

31/03/07<br />

0.5 g Instytut Farmaceutyczny 31/03/06<br />

1 g Instytut Farmaceutyczny 31/03/06<br />

2 g Instytut Farmaceutyczny 31/03/06<br />

7788 Macmiror Nifuratelum Film-coated tablets 200 mg Poli Industria Chimica S.p.A 30/04/04<br />

7789 Macmiror complex Nifuratelum +<br />

Nystatinum<br />

7790 Macmiror complex 500 Nifuratelum +<br />

Nystatinum<br />

Vaginal ointment (100mg +<br />

40 000 j.m.)/g<br />

Pessary 500mg +<br />

200000 j.m.<br />

Poli Industria Chimica S.p.A 30/04/04<br />

Poli Industria Chimica S.p.A 30/04/04<br />

7791 Macro — Albumon Kit Seroalbuminum, Humanum, Macroaggregatum Fodor Józef National Center<br />

of Public Health<br />

7792 MACRODEX 6 % z Chlorkiem<br />

Sodu<br />

Dextranum 6 % +<br />

Natrii chloridum<br />

Solution for<br />

intravenous infusion<br />

60 mg/ml Lithuanian, Ice-Landic &<br />

Swedish Joint Stock Company<br />

Closed Corporation<br />

‘ILSANTA’<br />

31/12/08<br />

31/12/08<br />

7793 Macromax — Inc Azithromycinum Capsules 250 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

7794 Madopar 62,5 Benserazidum +<br />

Levodopum<br />

7795 Madopar 62,5 Benserazidum +<br />

Levodopum<br />

7796 Madopar 125 Benserazidum +<br />

Levodopum<br />

7797 Madopar 125 Benserazidum +<br />

Levodopum<br />

7798 Madopar 250 Benserazidum +<br />

Levodopum<br />

7799 Madopar 250 Benserazidum +<br />

Levodopum<br />

7800 Madopar HBS Benserazidum +<br />

Levodopum<br />

Capsules 12,5mg +<br />

50mg<br />

Soluble tablets 12,5mg +<br />

50mg<br />

Capsules 25mg +<br />

100mg<br />

Soluble tablets 25mg +<br />

100mg<br />

Capsules 25mg +<br />

100mg<br />

Tablets 50mg +<br />

200mg<br />

Capsules 25mg +<br />

100mg<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

7801 Magalphil 800 Magaldratum Chewable tablets 800 mg Philopharm GmbH<br />

Quedlinburg<br />

31/05/04<br />

31/12/08<br />

31/05/04<br />

31/12/08<br />

31/05/04<br />

31/05/04<br />

11/12/05<br />

31/12/08


EN<br />

1090 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7802 Magareductol Maga-Herba, Legionowo 31/12/08<br />

7803 Magarisma Maga-Herba, Legionowo 31/12/08<br />

7804 Magasedat Maga-Herba, Legionowo 31/12/08<br />

7805 Magespan Magnesii hydroaspartas Tablets 40 mg Mg ++ Espefa Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

7806 Magium 10 Magnesii oxidum Effervescent tablets 10 mmoli<br />

Mg2+<br />

30/11/05<br />

HEXAL AG 31/12/08<br />

7807 Magium 5 Magnesii oxidum Effervescent tablets 5 mmoli Mg2+ HEXAL AG 31/12/08<br />

7808 Maglek B6 Magnesii lactas +<br />

Pyridoxinum (vit B6)<br />

7809 Magmill Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

7811 Magne B6 Magnesii lactas +<br />

Pyridoxinum (vit B6)<br />

7812 Magne B6 Magnesii lactas +<br />

Pyridoxinum (vit B6)<br />

7810 Magne B6 Magnesii lactas +<br />

Pyridoxinum (vit B6)<br />

Tablets Lek-AM Sp. z o.o.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Suspension Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

5/07/06<br />

31/12/08<br />

Film-coated tablets 470mg + 5mg Sanofi Winthrop-Gentilly 30/04/04<br />

Film-coated tablets 470mg + 5mg Sanofi-Synthelabo Sp. z o.o. 28/02/06<br />

Oral solution (186mg +<br />

10mg)/10ml<br />

Sanofi Winthrop GmbH 3/10/06<br />

7813 Magnefar Magnesii hydroaspartas Tablets 34 mg Mg ++ P.P.H.U. Biofarm Sp. z o.o. 31/05/05<br />

7814 Magnefar B6 Magnesii hydroaspartas<br />

+ Pyridoxinum (vit B6)<br />

7815 Magnefar B6 — Junior Magnesii hydroaspartas<br />

+ Pyridoxinum<br />

7816 MAGNESIT/MAMMA comp.<br />

ampułki<br />

7817 MAGNESIT/MAMMA comp.<br />

granulki<br />

Tablets P.P.H.U. Biofarm Sp. z o.o. 31/05/05<br />

Tablets 30 mg Mg2+ +<br />

0,3 mg wit. B6<br />

P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

7818 Magnesium Asparticum 0,6 Magnesii hydroaspartas Tablets 40 mg Mg ++ Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’, Bydgoszcz<br />

7819 Magnesium effervescens Magnesii carbonas Effervescent granules 40 mg Mg++/<br />

5g<br />

7820 Magnesium phosphoricum<br />

comp.<br />

7821 Magnesium phosphoricum<br />

comp.<br />

7822 Magnesium sulfuricum Magnesii stearas Soluble powder for veterinary<br />

use<br />

7823 Magnesium Sulfuricum 20 % Magnesii stearas Solution for veterinary<br />

use<br />

7824 MAGNESIUM SULFURI-CUM/<br />

OVARIA comp. amp.<br />

7825 MAGNESIUM SULFURI-CUM/<br />

OVARIA comp. gran.<br />

Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

31/01/06<br />

31/01/06<br />

Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

Granules WALA-Heilmittel GmbH 24/05/07<br />

Biofactor Sp. z o.o. 7/02/07<br />

Zakłady Farmaceutyczne<br />

‘Biowet’<br />

29/09/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

7826 Magnesol 150 Magnesii citras Effervescent tablets 150 mg Mg ++ Krka d.d., Novo mesto 31/07/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1091<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7827 Magnevist Solution for<br />

intravenous injection<br />

7828 Magnevist Enteral Concentrate for oral<br />

and rectal solution<br />

469 mg/ml Schering AG 30/04/04<br />

9.38 mg/ml Schering AG 31/12/04<br />

7829 Magnevit Granules VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

31/12/05<br />

7830 Magnez 120 Magnesii carbonas Effervescent tablets 120 mg Mg ++ Pharmavit Kft. 30/06/04<br />

7831 Magnezin Magnesii carbonas Tablets 130 mg Mg ++ Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

7832 Magnezin Magnesii carbonas Tablets 52 mg Mg ++ Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/11/05<br />

30/11/05<br />

7833 Magnezu chlorek Biochem, Warszawa 30/11/05<br />

7834 Magnezu chlorek Pharma Zentrale 30/11/05<br />

7835 Magnezu siarczan Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/05<br />

7836 Magnezu siarczan Galenus, Warszawa 31/12/05<br />

7837 Magnezu siarczan Hasco-Lek, Wrocław 31/12/05<br />

7838 Magnezu siarczan Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

31/12/05<br />

7839 Magnezu siarczan Pampa, Piaseczno 31/12/05<br />

7840 Magnezu siarczan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

31/12/05<br />

7841 Magnezu siarczan PPF GEMI, Karczew 31/12/05<br />

7842 Magnezu siarczan wysuszony BUFA b.v. Pharmaceutical<br />

Products<br />

31/03/06<br />

7843 Magnezu siarczan wysuszony Pharma Cosmetic, Kraków 31/03/06<br />

7844 Magnezu siarczan wysuszony Pharma Zentrale 31/03/06<br />

7845 Magnezu siarczan wysuszony Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

7846 Magnezu siarczan wysuszony PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/03/06<br />

31/03/06<br />

7847 Magnezu stearynian Pharma Zentrale 14/02/05<br />

7848 Magnezu tlenek BUFA b.v. Pharmaceutical<br />

Products<br />

30/11/05<br />

7849 Magnezu tlenek Pharma Cosmetic, Kraków 30/11/05<br />

7850 Magnezu tlenek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

30/11/05<br />

7851 Magnezu we˛glan A.C.E.F., Włochy 31/12/08<br />

7852 Magnezu we˛glan Farm-Impex s.j., Gliwice 31/12/08<br />

7853 Magnezu we˛glan Pampa, Piaseczno 31/12/08<br />

7854 Magnezu we˛glan Pharma Cosmetic, Kraków 31/12/08<br />

7855 Magnezu we˛glan Pharma Zentrale 31/12/08


EN<br />

1092 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7856 Magnezu we˛glan PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

7857 Magnezytki Magnesii lactas Film-coated tablets Sanofi-Synthelabo Sp. z o.o. 30/10/05<br />

7858 Magnokal Kalii hydroaspartas +<br />

Magnesii hydroaspartas<br />

7859 Magnokal Kalii hydroaspartas +<br />

Magnesii hydroaspartas<br />

Powder for oral<br />

solution<br />

(17mg Mg ++;<br />

54mg K+)/4g<br />

Tablets (17mg Mg ++;<br />

54mg K+)/4g<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/03/05<br />

31/03/05<br />

7860 Magnosil Magnesii silicas Tablets 0.5 g ICN Polfa Rzeszów S.A. 31/01/06<br />

7861 Magsolvit B6 Magnesii gluconas +<br />

Magnesii lactas +<br />

Pyridoxinum (vit B6)<br />

7862 Magvit B6 Magnesii lactas +<br />

Pyridoxinum (vit B6)<br />

Syrup Farmaceutyczno —<br />

Chemiczna Spółdzielnia Pracy<br />

Galenus<br />

Gastro-resistant<br />

tablets<br />

48 mg Mg ++ GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

7864 Majamil Diclofenacum Film-coated tablets 25 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

7865 Majamil Diclofenacum Film-coated tablets 50 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

7863 Majamil Diclofenacum Solution for<br />

intramuscular<br />

injection<br />

7866 Majamil prolongatum Diclofenacum Film-coated, prologed<br />

release tablets<br />

25 mg/ml Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

15/11/06<br />

31/01/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

7867 Majorana Vaginal gel WALA-Heilmittel GmbH 24/05/07<br />

7868 Makatussin saft zuckerfrei Liquid Roland Arzneimittel GmbH 31/12/08<br />

7869 Makatussin tropfen Byk Roland Polska 31/12/08<br />

7870 Malgacid Hydrotalcitum Buccal tablet 500 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

7871 Malgacid Hydrotalcitum Buccal tablets 500 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘Ziołolek’ Sp.<br />

z o.o.<br />

7872 Malia kaszel, syrop DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

7873 Maltimal (poprzednia nazwa<br />

althamal)<br />

Syrup Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

7874 Malugastrin Magaldratum Buccal tablet 400 mg Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

7875 Malugastrin Magaldratum Oral suspension 400 mg/5ml Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

7876 Mandol Cefamandolum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

30/06/05<br />

31/12/08<br />

14/11/05<br />

31/12/08<br />

28/02/06<br />

28/02/06<br />

1 g Eli Lilly Italia S.p.A. 30/04/04<br />

7877 Mangamag Preparat złoz˙ony Buccal tablets Łowicke Zakłady<br />

Farmaceutyczne POLFA<br />

Łyszkowice<br />

7878 Maninil 1,75 Glibenclamidum Tablets 1.75 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

7879 Maninil 3,5 Glibenclamidum Tablets 3.5 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

31/12/08<br />

31/12/04<br />

31/12/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1093<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7880 Mannitol Farm-Impex s.j., Gliwice 31/12/08<br />

7881 Mannitol Pharma Cosmetic, Kraków 31/12/08<br />

7882 Mannitol Pharma Zentrale 31/12/08<br />

7883 Mannitol PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

7884 Mannitol 0,54 % + Sorbitol<br />

2,7 %<br />

7885 MANNITOL 0,54 % i<br />

SORBITOL 2,7 %<br />

Mannitolum +<br />

Sorbitolum<br />

Mannitolum +<br />

Sorbitolum<br />

Solution for irrigation (5,4mg +<br />

27mg)/ml<br />

Solution for irrigation (5,4 + 27)mg/<br />

ml<br />

7886 Mannitol 10 % Mannitolum Solution for<br />

intravenous infusion<br />

7887 Mannitol 20 % Mannitolum Solution for<br />

intravenous infusion<br />

7888 Mannitol 20 % Mannitolum Solution for<br />

intravenous infusion<br />

7889 Manti Aluminii hydroxidum +<br />

Magnesii hydroxidum +<br />

Simeticonum<br />

7890 Manti Aluminii hydroxidum +<br />

Magnesii hydroxidum +<br />

Simeticonum<br />

7891 Manti Aluminii hydroxidum +<br />

Magnesii hydroxidum +<br />

Simeticonum<br />

7892 Manti Forte Aluminii hydroxidum +<br />

Magnesii hydroxidum +<br />

Simeticonum<br />

7893 Manti Forte Aluminii hydroxidum +<br />

Magnesii hydroxidum +<br />

Simeticonum<br />

7894 Manti Forte Aluminii hydroxidum +<br />

Magnesii hydroxidum +<br />

Simeticonum<br />

31/12/08<br />

Baxter S.p.A. 21/06/06<br />

Baxter Terpol Sp. z o.o. 31/12/08<br />

100 mg/ml Baxter Terpol Sp. z o.o. 27/01/05<br />

200 mg/ml Fresenius Kabi Polska Sp. z<br />

o.o.<br />

31/01/06<br />

200 mg/ml Baxter Terpol Sp. z o.o. 27/01/05<br />

Buccal tablets US Pharmacia International<br />

Inc.<br />

Buccal tablets US Pharmacia International<br />

Inc.<br />

Oral suspension US Pharmacia International<br />

Inc.<br />

Buccal tablets US Pharmacia International<br />

Inc.<br />

Buccal tablets US Pharmacia International<br />

Inc.<br />

Oral suspension US Pharmacia International<br />

Inc.<br />

7895 Mapryl Enalaprili maleas Tablets 10 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

7896 Mapryl Enalaprili maleas Tablets 20 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

7897 Mapryl Enalaprili maleas Tablets 5 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

7898 Marbocyl 10 Marbofloksacyna Solution for veterinary<br />

use<br />

7899 Marbocyl 20 mg Marbofloksacyna Tablet for veterinary<br />

use<br />

7900 Marbocyl 5 mg Marbofloksacyna Tablet for veterinary<br />

use<br />

7901 Marbocyl 80 mg Marbofloksacyna Tablet for veterinary<br />

use<br />

7902 Marcaine — Adrenaline 0,25 % Bupivacainum +<br />

Epinephrinum<br />

Solution for injection (2,5mg +<br />

0,005mg)/ml<br />

30/09/04<br />

30/09/04<br />

31/03/07<br />

30/11/04<br />

30/11/04<br />

31/03/07<br />

30/04/06<br />

25/10/05<br />

25/10/05<br />

Vetoquinol S.A. 12/03/06<br />

Vetoquinol S.A. 8/05/06<br />

Vetoquinol S.A. 20/04/06<br />

Vetoquinol S.A. 8/05/06<br />

AstraZeneca AB 30/06/04


EN<br />

1094 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7903 Marcaine — Adrenaline 0,5 % Bupivacainum +<br />

Epinephrinum<br />

Solution for injection (5mg +<br />

0,005mg)/ml<br />

AstraZeneca AB 30/06/04<br />

7904 Marcaine 0,25 % Bupivacainum Solution for injection 2.5 mg/ml AstraZeneca AB 30/06/04<br />

7905 Marcaine 0,5 % Bupivacainum Solution for injection 5 mg/ml AstraZeneca AB 30/06/04<br />

7906 Marcaine Spinal 0,5 % Heavy Bupivacainum Solution for injection 5 mg/ml AstraZeneca AB 30/06/04<br />

7907 Marek — Vac Szczepionka przeciw<br />

chorobie Mareka dla<br />

kurcza˛t<br />

7908 Mareol Olej z tkanki ryb<br />

morskich<br />

Suspension for veterinary<br />

use<br />

FATRO 31/12/08<br />

Capsules, soft 500 mg Agropharm S.A. 16/05/07<br />

7909 Marigold Gel. Z˙el z nagietka Preparat złoz˙ony Gel for external use Alpine Herbs Produkte AG 30/04/04<br />

7910 Marigold Ointment. Mas´ć<br />

nagietkowa<br />

Preparat złoz˙ony Ointment Alpine Herbs Produkte AG 30/04/04<br />

7911 Marinyl Q10 Capsules 50mg HEALTH Purificato<br />

Molnlycke, Szwecja<br />

7912 Mariomigran Chrysanthemi parthenii<br />

succus<br />

7913 Marmot Ointment. Mas´ć z<br />

sadła s´wistaka<br />

7914 Marvelon Desogestrelum +<br />

Ethinylestradiolum<br />

7915 Masticef Cefacetril sodowy Intramammary<br />

suspension<br />

7916 Masticlox L Ampicillinum +<br />

Cloxacillnum<br />

7917 Masticlox Z Ampicillinum +<br />

Cloxacillnum<br />

7918 Mastiject Fort Tetracyklina,<br />

neomycyna,<br />

bacytracyna,<br />

prednizolon<br />

7919 Mastipen L Sól sodowa<br />

benzylopenicyliny,<br />

siarczan<br />

dihydrostreptomycyny,<br />

sól sodowa nafciliny<br />

7920 Mastipen Z Sól prokainowa<br />

benzylopenicyliny,<br />

siarczan<br />

dihydrostreptomycyny,<br />

sól sodowa nafciliny<br />

7921 Mastiprewent Olejek eukaliptusowy,<br />

kamfora, mentol,<br />

wazelina z˙ółta,<br />

euceryna<br />

7922 Mastisan PN DC Benzylopenicylina<br />

prokainowa-<br />

Neomycyny siarczan<br />

7923 Mastisan PN MC Benzylopenicylina<br />

prokainowa,<br />

neomycyna<br />

31/12/08<br />

Liquid Phytopharm Kle˛ka S.A. 31/12/08<br />

Preparat złoz˙ony Ointment Alpine Herbs Produkte AG 31/07/04<br />

Tablets 0,15mg +<br />

0,03mg<br />

for veterinary<br />

use<br />

Ointment for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Ointment for veterinary<br />

use<br />

Ointment for veterinary<br />

use<br />

Ointment for veterinary<br />

use<br />

Ointment for veterinary<br />

use<br />

Intramammary<br />

suspension<br />

Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

Organon N.V. —<br />

Kloosterstraat<br />

Drwalewskie Zakłady<br />

PrzemysłuBioweterynaryjnego<br />

30/06/04<br />

24/09/04<br />

Biowet Drwalew 31/12/08<br />

Biowet Drwalew 31/12/08<br />

Intervet International 31/12/08<br />

Biowet Drwalew 31/12/08<br />

Biowet Drwalew 31/12/08<br />

Biowet Puławy 31/12/08<br />

PW Vet-Agro 4/08/04<br />

Vet-Agro 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1095<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7924 Mastizym Trypsyna,<br />

Chymotrypsyna,<br />

Papaina, Witamina A,<br />

Octan a tokoferolu<br />

7925 Mastlek Amoxicillinum +<br />

Neomycinum<br />

Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Veyx-Pharma 10/02/04<br />

Biowet Puławy 31/12/08<br />

7926 Mastodynon Tablets Bionorica AG 19/07/07<br />

7927 Mastodynon N Bionorica, Niemcy 31/12/08<br />

7928 Mastycyd D Bradophen, Liquid for veterinary<br />

use<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

7929 Mas´ć arnikowa Ointment 200 mg/g Elissa Wytwórnia Artykułów<br />

Kosmetycznych i<br />

Perfumeryjnych mgr farm.<br />

Irena Ocioszyńska<br />

30/06/04<br />

30/10/05<br />

7930 Mas´ć arnikowa Pampa, Piaseczno 19/09/06<br />

7931 Mas´ć borna Aflofarm Farmacja Polska,<br />

Pabianice<br />

24/10/05<br />

7932 Mas´ć borna Avena, Bydgoszcz 24/10/05<br />

7933 Mas´ć borna Unia, Warszawa 24/10/05<br />

7934 Mas´ć borna Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

7935 Mas´ć borna Acidum boricum Ointment for veterinary<br />

use<br />

24/10/05<br />

Herbafarm Sp. z o.o. 22/11/06<br />

7936 Mas´ć borna. Ung. acidi borici Acidum boricum Ointment 10 % Avena 31/12/04<br />

7937 Mas´ć borowinowa Ointment Sulphur Zdrój Exim —<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/08/05<br />

7938 Mas´ć bursztynowa Farmina Sp. z o.o., Kraków 24/11/05<br />

7939 Mas´ć bursztynowa Laboratorium<br />

Farmaceutyczne<br />

HOMEOFARM Sp. z o.o.<br />

7940 Mas´ć cholesterolowa Cholesteroli<br />

unguentum<br />

7941 Mas´ć cholesterolowa Cholesteroli<br />

unguentum<br />

7942 Mas´ć cholesterolowa Cholesteroli<br />

unguentum<br />

7943 Mas´ć cholesterolowa Cholesteroli<br />

unguentum<br />

7944 Mas´ć cholesterolowa Cholesteroli<br />

unguentum<br />

7945 Mas´ć cholesterolowa Cholesteroli<br />

unguentum<br />

Ointment Przedsie˛biorstwo<br />

Produkcyjno-Usługowo-<br />

Handlowe AUGMED<br />

24/11/05<br />

19/04/07<br />

Lefarm, Bydgoszcz 19/04/07<br />

Pampa, Piaseczno 19/04/07<br />

Pharma Cosmetic, Kraków 19/04/07<br />

Pharma Zentrale 19/04/07<br />

Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

7946 Mas´ć cynkowa Aflofarm Farmacja Polska,<br />

Pabianice<br />

30/06/05<br />

31/12/08


EN<br />

1096 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7947 Mas´ć cynkowa Apipol-Farma, Mys´lenice 31/12/08<br />

7948 Mas´ć cynkowa AUGMED, Dawidy Bankowe 31/12/08<br />

7949 Mas´ć cynkowa Cefarm Gdańsk 31/12/08<br />

7950 Mas´ć cynkowa Elissa, Warszawa 31/12/08<br />

7951 Mas´ć cynkowa Laboratorium<br />

Farmaceutyczne<br />

HOMEOFARM Sp. z o.o.<br />

7952 Mas´ć cynkowa z kwasem<br />

salicylowym<br />

7953 Mas´ć cynkowa z kwasem<br />

salicylowym<br />

7954 Mas´ć cynkowa z kwasem<br />

salicylowym<br />

7955 Mas´ć cynkowa z kwasem<br />

salicylowym<br />

7956 Mas´ć cynkowa z kwasem<br />

salicylowym<br />

7957 Mas´ć cynkowa z kwasem<br />

salicylowym<br />

7958 Mas´ć cynkowa z kwasem<br />

salicylowym<br />

7959 Mas´ć cynkowa z kwasem<br />

salicylowym<br />

Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/08<br />

31/12/05<br />

Avena, Bydgoszcz 31/12/05<br />

Elissa, Warszawa 31/12/05<br />

Hasco-Lek, Wrocław 31/12/05<br />

Laboratorium<br />

Farmaceutyczne<br />

HOMEOFARM Sp. z o.o.<br />

31/12/05<br />

Lefarm, Bydgoszcz 31/12/05<br />

PZF ‘Cefarm-Lublin’ S.A. 31/12/05<br />

Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

31/12/05<br />

7960 Mas´ć do nosa Ointment WALA-Heilmittel GmbH 24/05/07<br />

7961 Mas´ć do nosa dla dzieci Ointment WALA-Heilmittel GmbH 24/05/07<br />

7962 Mas´ć Gemiderma Acidum boricum Ointment 5 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

31/01/06<br />

7963 Mas´ć glicerolowa Pharma Zentrale 14/02/05<br />

7964 Mas´ć goja˛ca z róz˙y Ointment WALA-Heilmittel GmbH 24/05/07<br />

7965 Mas´ć ichtiolowa Apipol-Farma, Mys´lenice 31/12/08<br />

7966 Mas´ć ichtiolowa Avena, Bydgoszcz 31/12/08<br />

7967 Mas´ć ichtiolowa Cefarm Szczecin 31/12/08<br />

7968 Mas´ć ichtiolowa Hasco-Lek, Wrocław 31/12/08<br />

7969 Mas´ć ichtiolowa Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

31/12/08<br />

7970 Mas´ć ichtiolowa Maggie, Warszawa 31/12/08<br />

7971 Mas´ć ichtiolowa PPF GEMI, Karczew 31/12/08<br />

7972 Mas´ć ichtiolowa PZF ‘Cefarm-Lublin’ S.A. 31/12/08<br />

7973 Mas´ć ichtiolowa Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

31/12/08<br />

7974 Mas´ć ichtiolowo-kamforowa Labor, Wrocław 19/09/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1097<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

7975 Mas´ć kamforowa Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/08<br />

7976 Mas´ć kamforowa AUGMED, Dawidy Bankowe 31/12/08<br />

7977 Mas´ć kamforowa Avena, Bydgoszcz 31/12/08<br />

7978 Mas´ć kamforowa Cefarm Gdańsk 31/12/08<br />

7979 Mas´ć kamforowa Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

31/12/08<br />

7980 Mas´ć kamforowa Lefarm, Bydgoszcz 31/12/08<br />

7981 Mas´ć kamforowa PPF GEMI, Karczew 31/12/08<br />

7982 Mas´ć kamforowa PZF ‘Cefarm-Lublin’ S.A. 31/12/08<br />

7983 Mas´ć kamforowa Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

7984 Mas´ć kamforowa Camphorum Ointment for veterinary<br />

use<br />

31/12/08<br />

Herbafarm Sp. z o.o. 22/11/06<br />

7985 Mas´ć kasztanowa Ointment 50 mg/g Farmal — Wytwórnia<br />

Farmaceutyczna<br />

31/05/06<br />

7986 Mas´ć kasztanowa Ointment Alpine Herbs Produkte AG 30/11/04<br />

7987 Mas´ć majerankowa Aflofarm Farmacja Polska,<br />

Pabianice<br />

4/08/07<br />

7988 Mas´ć majerankowa Avena, Bydgoszcz 4/08/07<br />

7989 Mas´ć majerankowa Cefarm Gdańsk 4/08/07<br />

7990 Mas´ć majerankowa Cefarm Szczecin 4/08/07<br />

7991 Mas´ć majerankowa Elissa, Warszawa 4/08/07<br />

7992 Mas´ć majerankowa Hasco-Lek, Wrocław 4/08/07<br />

7993 Mas´ć majerankowa Laboratorium<br />

Farmaceutyczne<br />

HOMEOFARM Sp. z o.o.<br />

7994 Mas´ć majerankowa Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

4/08/07<br />

4/08/07<br />

7995 Mas´ć majerankowa Lefarm, Bydgoszcz 4/08/07<br />

7996 Mas´ć majerankowa PPF GEMI, Karczew 4/08/07<br />

7997 Mas´ć majerankowa PZF ‘Cefarm-Lublin’ S.A. 4/08/07<br />

7998 Mas´ć majerankowa Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

7999 Mas´ć majerankowa -ung.<br />

Majoranae<br />

8000 Mas´ć na odciski Acidum lacticum +<br />

Acidum salicylicum<br />

8001 Mas´ć na odciski Acidum lacticum +<br />

Acidum salicylicum<br />

8002 Mas´ć na odciski Acidum salicylicum +<br />

meliloti emplastrum<br />

Ointment Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Ointment Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

Ointment (400mg +<br />

100mg)/g<br />

Ointment (500mg +<br />

500mg)/g<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

4/08/07<br />

31/12/04<br />

30/10/05<br />

10/05/06<br />

31/01/06


EN<br />

1098 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8003 Mas´ć na odciski Maggie Acidum lacticum +<br />

Acidum salicylicum<br />

Ointment Maggie — Laboratorium<br />

Farmaceutyczno-Kosmetyczne<br />

31/01/06<br />

8004 Mas´ć na odle yny Pampa, Piaseczno 19/09/06<br />

8005 Mas´ć Nagietkowa Ointment 100 mg/g Farmal — Wytwórnia<br />

Farmaceutyczna<br />

8006 Mas´ć Nagietkowa Ointment 200 mg/g Elissa Wytwórnia Artykułów<br />

Kosmetycznych i<br />

Perfumeryjnych mgr farm.<br />

Irena Ocioszyńska<br />

8007 Mas´ć Nagietkowa Ointment 700 mg/g Ziaja Ltd. — Zakład<br />

Produkcji Leków<br />

9/02/05<br />

9/02/05<br />

9/02/05<br />

8008 Mas´ć nagietkowa Farmina Sp. z o.o., Kraków 9/02/05<br />

8009 Mas´ć nagietkowa Pampa, Piaseczno 9/02/05<br />

8010 Mas´ć ochronna z witamina˛ A Retinolum Ointment 800 j.m./g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

8011 Mas´ć piele˛gnacyjna dla dzieci<br />

Pupilek<br />

Allantoinum + Zinci<br />

oxydum<br />

8012 Mas´ć pieprzowcowa Capsici extractum<br />

spissum<br />

8013 Mas´ć pie˛ciornikowa złoz˙ona Tormentillae<br />

unguentum<br />

compositum<br />

8014 Mas´ć pie˛ciornikowa złoz˙ona Tormentillae<br />

unguentum<br />

compositum<br />

8015 Mas´ć pie˛ciornikowa złoz˙ona Tormentillae<br />

unguentum<br />

compositum<br />

8016 Mas´ć pie˛ciornikowa złoz˙ona Tormentillae<br />

unguentum<br />

compositum<br />

8017 Mas´ć pie˛ciornikowa złoz˙ona Tormentillae<br />

unguentum<br />

compositum<br />

8018 Mas´ć pie˛ciornikowa złoz˙ona Tormentillae<br />

unguentum<br />

compositum<br />

8019 Mas´ć pie˛ciornikowa złoz˙ona Tormentillae<br />

unguentum<br />

compositum<br />

8020 Mas´ć pie˛ciornikowa złoz˙ona Tormentillae<br />

unguentum<br />

compositum<br />

8021 Mas´ć pie˛ciornikowa złoz˙ona Tormentillae<br />

unguentum<br />

compositum<br />

8022 Mas´ć pie˛ciornikowa złoz˙ona Tormentillae<br />

unguentum<br />

compositum<br />

Ointment (20mg +<br />

70mg)/g<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

Ointment Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Aflofarm Farmacja Polska,<br />

Pabianice<br />

10/05/06<br />

31/01/06<br />

31/12/08<br />

14/05/07<br />

Cefarm Gdańsk 14/05/07<br />

Labor, Wrocław 14/05/07<br />

Laboratorium<br />

Farmaceutyczne<br />

HOMEOFARM Sp. z o.o.<br />

14/05/07<br />

Lefarm, Bydgoszcz 14/05/07<br />

PPF GEMI, Karczew 14/05/07<br />

Prolab, Paterek k/Nakła 14/05/07<br />

Unia, Warszawa 14/05/07<br />

Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

14/05/07<br />

Ziaja, Gdańsk 14/05/07<br />

8023 Mas´ć Pie˛ciornikowa złoz˙ona Ointment Farmina Sp. z o.o. 14/05/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1099<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8024 Mas´ć Propolisowa 3 % Ointment 30 mg/g Apipol — Farma Sp. z o.o.<br />

Przedsie˛biorstwo Pszczelarsko<br />

— Farmaceutyczne<br />

8025 Mas´ć Propolisowa 7 % Ointment Barć — Pasieka im. ks. dr<br />

Henryka Ostacha<br />

8026 Mas´ć przeciw odciskom Acidum lacticum +<br />

Acidum salicylicum<br />

8027 Mas´ć przeciw odciskom Acidum lacticum +<br />

Acidum salicylicum<br />

8028 Mas´ć przeciw odciskom i<br />

zgrubieniom skóry >Rekord<br />

Łuszczy<<br />

Ointment Cefarm Lublin S.A.<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

30/10/05<br />

31/12/04<br />

31/01/06<br />

Ointment Farmina Sp. z o.o. 31/01/06<br />

Acidum salicylicum Ointment 200 mg/g Farmal — Wytwórnia<br />

Farmaceutyczna<br />

8029 Mas´ć Retynowa Tretinoinum Ointment 0.5 mg/g Coel s.c.- Laboratorium<br />

Farmaceutyczne Wytwórnia<br />

Euceryny<br />

8030 Mas´ć Rumiankowa Ointment 200 mg/g Elissa Wytwórnia Artykułów<br />

Kosmetycznych i<br />

Perfumeryjnych mgr farm.<br />

Irena Ocioszyńska<br />

31/12/05<br />

31/01/06<br />

31/05/06<br />

8031 Mas´ć rumiankowa Pampa, Piaseczno 19/09/06<br />

8032 Mas´ć siarkowo-salicylowomydlana<br />

Acidum salicylicum +<br />

Sulfur + Sapo kalinus<br />

Ointment Cefarm Lublin S.A.<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

8033 Mas´ć szałwiowa Ointment 200 mg/g Elissa Wytwórnia Artykułów<br />

Kosmetycznych i<br />

Perfumeryjnych mgr farm.<br />

Irena Ocioszyńska<br />

30/10/05<br />

31/05/06<br />

8034 Mas´ć tranowa Ointment 400 mg/g Farmina Sp. z o.o. 31/12/08<br />

8035 Mas´ć tranowa Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/08<br />

8036 Mas´ć tranowa AUGMED, Dawidy Bankowe 31/12/08<br />

8037 Mas´ć tranowa Avena, Bydgoszcz 31/12/08<br />

8038 Mas´ć tranowa Bartpol, Poznań 31/12/08<br />

8039 Mas´ć tranowa Cefarm Gdańsk 31/12/08<br />

8040 Mas´ć tranowa Hasco-Lek, Wrocław 31/12/08<br />

8041 Mas´ć tranowa Maggie, Warszawa 31/12/08<br />

8042 Mas´ć tranowa PZF ‘Cefarm-Lublin’ S.A. 31/12/08<br />

8043 Mas´ć tranowa Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

8044 Mas´ć tranowa Olej wa˛tłuszowy Ointment for veterinary<br />

use<br />

8045 Mas´ć witaminowa goja˛ca Retinolum Ointment 800 j.m./g Cefarm Lublin S.A.<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

31/12/08<br />

Herbafarm Sp. z o.o. 22/11/06<br />

31/01/06


EN<br />

1100 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8046 Mas´ć witaminowa ochronna Retinolum Ointment 800 j.m./g Cefarm Lublin S.A.<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

8047 Mas´ć witaminowa ochronna Retinolum Ointment 800 j.m./g Homeofarm Sp. z o.o.<br />

Laboratorium<br />

Farmaceutyczne<br />

31/01/06<br />

31/01/06<br />

8048 Mas´ć z salicylanem metylu Chema-Elektromet, Rzeszów 31/12/08<br />

8049 Mas´ć z salicylanem metylu Lefarm, Bydgoszcz 31/12/08<br />

8050 Mas´ć z sulfobitumianianem<br />

amonowym<br />

8051 Mas´ć z sulfobituminianem<br />

amonowym<br />

8052 Mas´ć z sulfobituminianem<br />

amonowym<br />

8053 Mas´ć z sulfobituminianem<br />

amonowym<br />

8054 Mas´ć z sulfobituminianem<br />

amonowym<br />

8055 Mas´ć z sulfobituminianem<br />

amonowym<br />

Labor, Wrocław 14/06/06<br />

Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/05<br />

AUGMED, Dawidy Bankowe 31/12/05<br />

Cefarm Gdańsk 31/12/05<br />

Farmina Sp. z o.o., Kraków 31/12/05<br />

Lefarm, Bydgoszcz 31/12/05<br />

8056 Mas´ć z tlenkiem cynku Avena, Bydgoszcz 5/09/05<br />

8057 Mas´ć z tlenkiem cynku Lefarm, Bydgoszcz 5/09/05<br />

8058 Mas´ć z tlenkiem cynku PPF GEMI, Karczew 5/09/05<br />

8059 Mas´ć z tlenkiem cynku Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

8060 Mas´ć z tlenkiem cynku Zinci oxydum Ointment for veterinary<br />

use<br />

5/09/05<br />

Herbafarm Sp. z o.o. 22/11/06<br />

8061 Mas´ć z witamina˛ A Retinolum Ointment 400 j.m./g Farmina Sp. z o.o. 31/12/04<br />

8062 Mas´ć z witamina˛ A Retinolum Ointment 400 j.m./g Laboratorium Galenowe<br />

Olsztyn Sp. zo.o.<br />

8063 Mas´ć z witamina˛ A Retinolum Ointment Laboratorium Galenowe<br />

Katowice<br />

31/12/04<br />

31/12/04<br />

8064 Mas´ć zmie˛kczaja˛ca Pharma Zentrale 14/02/05<br />

8065 Matefit fix Preparat ziołowy Instant herbal tea Herbapol Białystok S.A. 31/12/08<br />

8066 Materna Prep. Witaminowy z<br />

mikroelementami<br />

Film-coated tablets Lederle Laboratories Division 30/04/04<br />

8067 Materna z selenem Film-coated tablets Wyeth-Ayerst Canada 25/04/07<br />

8068 Matrax Paracetamolum +<br />

Dextromethorphanum +<br />

Pseudoephedrinum<br />

8069 Matrax Paracetamolum +<br />

Dextromethorphanum +<br />

Pseudoephedrinum<br />

Capsules, soft preparat<br />

złoz˙ony<br />

Film-coated tablets preparat<br />

złoóz˙ny<br />

US Pharmacia 31/12/08<br />

US Pharmacia 31/12/08<br />

8070 Matrax Plus Capsules, soft US Pharmacia 31/12/08<br />

8071 Matrax Plus Film-coated tablets US Pharmacia 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1101<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8072 Max obroz˙a przeciw pchłom i<br />

kleszczom dla kota<br />

8073 Max obroz˙a przeciw pchłom i<br />

kleszczom dla psa<br />

Permetryna Collar for veterinary<br />

use<br />

permetryna Collar for veterinary<br />

use<br />

NBO Laboratoires 31/12/08<br />

NBO Laboratoires 31/12/08<br />

8074 Maxalt 10 Rizatriptanum Tablets 10 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

8075 Maxalt 5 Rizatriptanum Tablets 5 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

8076 Maxalt RPD 10 Rizatriptanum Tablets (lyophilisate) 10 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

8077 Maxalt RPD 5 Rizatriptanum Tablets (lyophilisate) 5 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

31/08/04<br />

31/08/04<br />

31/08/04<br />

31/08/04<br />

8078 Maxaquin Lomefloxacinum Tablets 400 mg Searle 31/12/08<br />

8079 Maxflu Syrop Paracetamolum +<br />

Chlorpheniraminum +<br />

Pseudoephedrinum<br />

Syrup preparat<br />

złoz˙ony<br />

8080 Maxiban 160 premix Narazyna, nikarbazyna Premix for veterinary<br />

use<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

Elanco Animal Health 31/12/08<br />

8081 Maxigra Sildenafili citras Film-coated tablets 25 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

8082 Maxigra Sildenafili citras Film-coated tablets 50 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

8083 Maxigra Sildenafili citras Film-coated tablets 100 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

8084 Maxipime Cefepimum Powder for solution<br />

for intravenous and<br />

intramuscular<br />

injection<br />

8085 Maxipime Cefepimum Powder for solution<br />

for intravenous and<br />

intramuscular<br />

injection<br />

8086 Maxipime Cefepimum Powder for solution<br />

for intravenous and<br />

intramuscular<br />

injection<br />

8087 Maxipiryn C Acidum acetylsalicylicum,<br />

Acidum ascorbicum<br />

8088 Maxitrol Dexamethasonum +<br />

Neomycinum +<br />

Polymyxinum B<br />

8089 Maxitrol Dexamethasonum +<br />

Neomycinum +<br />

Polymyxinum B<br />

8090 MBE Magnesii oxidum +<br />

Pyridoxinum (vit B6) +<br />

Tocopherolum<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

0.5 g Bristol-Myers Squibb S.p.A. 31/12/07<br />

1 g Bristol-Myers Squibb S.p.A. 31/12/07<br />

2 g Bristol-Myers Squibb S.p.A. 31/12/07<br />

Effervescent tablets PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

Eye drops, suspension Alcon Couvreur N.V. 30/06/04<br />

Eye ointment Alcon Couvreur N.V. 31/12/08<br />

Capsules, soft 150mg Mg ++,<br />

7,29mg +<br />

200mg<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

8091 Mecortolon Prednisolonum Cream 5 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8092 Mecortolon N Neomycinum +<br />

Prednisolonum<br />

Cream (5mg + 5mg)/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

24/05/06<br />

30/11/05<br />

31/03/05


EN<br />

1102 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8093 Medazepam Medazepamum Capsules 10 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8094 Medigox Metildigoxinum Tablets 0.1 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8095 Meditonsin Płyn Medice Chem.-Pharm. Fabrik<br />

Putter<br />

31/12/05<br />

31/08/05<br />

31/01/06<br />

8096 Medrol Methylprednisolonum Tablets 100 mg Pharmacia N.V./S.A. 2/10/06<br />

8097 Medrol Methylprednisolonum Tablets 16 mg Pharmacia N.V./S.A. 2/10/06<br />

8098 Medrol Methylprednisolonum Tablets 32 mg Pharmacia N.V./S.A. 2/10/06<br />

8099 Medrol Methylprednisolonum Tablets 4 mg Pharmacia N.V./S.A. 2/10/06<br />

8100 MEDULLA comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

8101 MEDULLA comp. gran. WALA-Heilmittel GmbH 19/03/05<br />

8103 Mefacit Acidum mefenamicum Capsules 250mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

8102 Mefacit Acidum mefenamicum Suppository 0.5 g SecFarm — Towarzystwo<br />

Przemysłowo-Handlowe Sp. z<br />

o.o.<br />

8104 Mefacit Acidum mefenamicum Tablets 250 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

26/09/07<br />

31/01/06<br />

31/12/05<br />

8106 Megace Megestrolum Oral suspension 40 mg/ml Bristol-Myers Squibb Co. 31/10/04<br />

8105 Megace Megestrolum Tablets 40 mg Bristol Myers Squibb GmbH 30/06/04<br />

8107 Megace 160 Megestrolum Tablets 160 mg Bristol Myers Squibb GmbH 9/07/06<br />

8108 Megalac Hydrotalcitum Chewable tablets 500 mg Krewel Meuselbach GmbH 31/12/08<br />

8109 Megalia Megestrolum Oral suspension 40 mg / ml VIPHARM S.A. Warszawa 31/12/08<br />

8110 Megavit Film-coated tablets Sun-Farm Sp.z o.o. Kołbiel 14/12/05<br />

8111 Megesin Megestrolum Tablets 160 mg S.C. Sindan S.R.L 4/07/07<br />

8112 Megesin Megestrolum Tablets 40 mg S.C. Sindan S.R.L 4/07/07<br />

8113 Megestrol Megestrolum Tablets 40 mg POLFA KUTNO S.A. 31/12/08<br />

8114 Megestrol Megestrolum Tablets 160 mg POLFA KUTNO S.A. 31/12/08<br />

8115 Megestrol Megestrolum Tablets 400 mg POLFA KUTNO S.A. 31/12/08<br />

8116 Megestrolum Megestrolum Oral suspension 40 mg/ml Labpharm Sp. z o.o. 31/12/08<br />

8117 Megion Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

1 g Biochemie GmbH — Kundl 11/10/06<br />

8118 Meglumin 1000 Metforminum Film-coated tablets 1000 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

8119 Meglumin 500 Metforminum Film-coated tablets 500 mg HEXAL AG 31/12/08<br />

8120 Meladerm Gel Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’,<br />

Pruszków<br />

8121 Melalthaeae Syrup 1870 mg/5ml Eko-Lek- Przedsiebiorstwo<br />

Produkcyjno-Handlowe Sp. z<br />

o.o.<br />

31/12/08<br />

31/12/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1103<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8122 Melalthaeae D Syrup 1950 mg/5ml Eko-Lek- Przedsiebiorstwo<br />

Produkcyjno-Handlowe Sp. z<br />

o.o.<br />

8123 Melatonin Melatoninum Tablets 3 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

8124 Melatonin Melatoninum Tablets 5 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

8125 Melatonin Melatoninum Tablets 1 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

8126 Melatonina Melatoninum Tablets 1 mg Lek-AM Sp. z o.o.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8127 Melatonina Melatoninum Tablets 3 mg Lek-AM Sp. z o.o.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8128 Melatonina Melatoninum Tablets 5 mg Lek-AM Sp. z o.o.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/12/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

23/04/06<br />

23/04/06<br />

24/08/05<br />

8129 Melatonina Melatoninum Tablets 3 mg Puritan's Pride Inc., USA 31/12/08<br />

8130 Melatonina Melatoninum Tablets 1 mg Medana Pharma TERPOL<br />

Group S.A.<br />

8131 Melatonina Melatoninum Tablets 3 mg Medana Pharma TERPOL<br />

Group S.A.<br />

8132 Melatonina Melatoninum Tablets 5 mg Medana Pharma TERPOL<br />

Group S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

8133 Melatonina Melatoninum Tablets 3 mg K & K Medicplast 31/12/08<br />

8134 Melatonina Melatoninum Tablets 5 mg K & K Medicplast 31/12/08<br />

8135 Melatonina + B 6 Melatoninum +<br />

Pyridoxini<br />

hydrochloridum<br />

8136 Melatonina o smaku<br />

pomarańczowym<br />

Tablets (3 mg +<br />

10 mg)<br />

Phoenix Laboratories Inc.,<br />

USA<br />

Melatoninum Tablets 3 mg Zakł. Chem.-Farm. ‘VIS’ sp. z<br />

o.o., Katowice<br />

8137 Melatoninum Melatoninum Tablets 3 mg CYNTFARM Sp. z o.o.,<br />

Pruszków<br />

8138 Melfarfarae Syrup Eko-Lek- Przedsiebiorstwo<br />

Produkcyjno-Handlowe Sp. z<br />

o.o.<br />

8139 Melfoeniculi Syrup 1890 mg/5ml Eko-Lek- Przedsiebiorstwo<br />

Produkcyjno-Handlowe Sp. z<br />

o.o.<br />

8140 Meliacid Acidum lacticum +<br />

Acidum salicylicum<br />

Ointment (100mg +<br />

400mg)/g<br />

Cefarm Gdańsk<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

8141 Meliherp Ointment 14 mg/g Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/05<br />

31/12/05<br />

31/01/06<br />

31/05/05<br />

8142 Melilotus-Homaccord Amp. Heel GmbH 31/12/08<br />

8143 Melilotus-Homaccord N Drops Heel GmbH 31/12/08<br />

8144 Melipass Preparat ziołowy Syrup Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

6/06/07


EN<br />

1104 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8145 Melipass G Preparat ziołowy Oral drops, solution Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

8146 Melisal Syrup Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

8147 Melisana Benediktinen<br />

Melissengeist<br />

14/03/07<br />

30/10/05<br />

Tincture Pharma-Zentrale GmbH 31/12/07<br />

8148 Melisana Klosterfrau Oral solution M.C.M. Klosterfrau<br />

Vetriebsgesellschaft m.b.H<br />

8149 Melissed Preparat ziołowy Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

8150 Melis-Tonic Preparat ziołowy Oral solution Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

8151 Melitab Dziurawiec, pasiflora,<br />

melisa, jez˙ówka<br />

8152 Mellinorm Pentoksyfillinum Prolonged release<br />

tablets<br />

Tablets for veterinary<br />

use<br />

30/04/04<br />

30/10/05<br />

30/10/05<br />

Biowet Puławy 31/12/08<br />

400 mg HEMOFARM D.D. 31/12/08<br />

8153 Meloksam Meloxicamum Tablets 7.5 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

8154 Meloksam Meloxicamum Tablets 15 mg Grodziskie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

8155 Meloksykam 0,15 % per os Meloxicanum Suspension for veterinary<br />

use<br />

8156 Meloksykam 0,5 % inj. Meloxicanum Solution for veterinary<br />

use<br />

25/01/05<br />

31/12/08<br />

Biowet Drwalew 31/12/08<br />

Biowet Drwalew 31/12/08<br />

8157 Meloxicam Meloxicamum Tablets 7,5mg i 15mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

8158 Meloxicam Meloxicamum Tablets 7,5 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

8159 Meloxicam Meloxicamum Tablets 15 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

8160 Memoaktyvit Bional Pharma BV 31/12/08<br />

8162 Memoplant Ginkgo biloba Film-coated tablets 40 mg Dr. Willmar Schwabe GmbH<br />

& Co.<br />

8161 Memoplant Ginkgo biloba Oral drops, solution 40 mg/ml Dr. Willmar Schwabe GmbH<br />

& Co.<br />

8163 Memorin Ginkgo bilobae folium<br />

extractum siccum<br />

Film-coated tablets 50 mg Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

8164 Memotropil Piracetamum Capsules 400 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

8165 Memotropil Piracetamum Film-coated tablets 1200 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

8166 Memotropil Piracetamum Film-coated tablets 800 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

8167 Memotropil 20 % Piracetamum Solution for<br />

intravenous infusion<br />

8168 Menbutone‘Werfft’ Menbuton Solution for veterinary<br />

use<br />

12 g/60 ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/04/04<br />

30/04/04<br />

31/12/08<br />

31/01/06<br />

15/03/06<br />

15/03/06<br />

5/07/06<br />

Werfft Chemie 30/06/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1105<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8169 Meningitec Meningococcus,<br />

tetravalent purified<br />

polysaccharides antigen<br />

8170 Menocaston Agni casti fructus<br />

tinctura<br />

8171 Menocim Cimicifuga racemosa<br />

rhizoma extractum<br />

siccum<br />

Suspension for<br />

intramuscular<br />

injection<br />

Wyeth-Lederle Pharma GmbH 11/10/06<br />

Oral drops Herbapol Lublin S.A. 27/09/06<br />

Film-coated tablets 2,5 mg Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

31/12/08<br />

8172 Menodoron N krople WELEDA 24/08/05<br />

8173 Menofem Cimicifugae racemosae<br />

extractum siccum<br />

8174 Menogon Menotropinum<br />

humanum<br />

Film-coated tablets Boehringer Ingelheim<br />

International GmbH<br />

Lyophilisate and<br />

solvent for solution<br />

for intramuscular<br />

injection<br />

75 j.m. FSH +<br />

75 j.m. LH<br />

31/12/08<br />

Ferring GmbH 31/08/04<br />

8175 Menopace Preparat złoz˙ony Capsules Vitabiotics Ltd. 31/12/08<br />

8176 Menopur Menotrophinum Powder and solvent for solution for<br />

itramuscular and subcutaneous<br />

injection<br />

Ferring GmbH 31/12/08<br />

8177 Mentho — Paraffinol Liquid Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

8178 MenthoBalm Ointment The Mentholatum Company<br />

Ltd.<br />

8179 Mentho-Paraffinol Paraffinum liquidum Oral solution 998.75 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

8180 Mentho-Paraffinol Liquid 100g + 125mg Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

8181 Mentho-Paraffinol Liquid Cefarm Lublin S.A.<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

30/10/05<br />

31/07/04<br />

27/09/06<br />

31/12/05<br />

31/01/06<br />

8182 Mentho-Paraffinol Oral solution Farmina Sp. z o.o. 31/07/05<br />

8183 Menthosept Cetylpyridinium Buccal tablet 1.5 mg Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

8184 Mentisana Instant herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

15/03/06<br />

9/08/06<br />

8187 Mentoklar Gel for external use Lek Pharmaceuticals d.d. 30/04/04<br />

8185 Mentoklar Inhalation vapour,<br />

solution<br />

Lek Pharmaceuticals d.d. 30/04/04<br />

8186 Mentoklar Nasal stick Lek Pharmaceuticals d.d. 30/04/04<br />

8188 Mentol Mentholum BUFA b.v. Pharmaceutical<br />

Products<br />

30/11/05<br />

8189 Mentol Mentholum Farm-Impex s.j., Gliwice 30/11/05<br />

8190 Mentol Mentholum Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

8191 Mentol Mentholum Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

30/11/05<br />

30/11/05<br />

8192 Mentol Mentholum Pharma Cosmetic, Kraków 30/11/05


EN<br />

1106 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8193 Mentol Mentholum Pharma Zentrale 30/11/05<br />

8194 Mentol Mentholum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

30/11/05<br />

8195 Mentol-z˙el Mentholum Gel 25 mg/g Kato LABS Sp. z o.o. 31/01/06<br />

8196 Mentowal Menthyli valeras Oral drops 650 mg/g Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

8197 Mepaprost R-kloprostenol Solution for veterinary<br />

use<br />

8198 Mepatar Oxytetracyclinum Powder for veterinary<br />

use<br />

8199 Mepatar granulat 20 % Oxytetracyclinum Granules for veterinary<br />

use<br />

8200 Mepatar granulat 40 % Oxytetracyclinum Granules for veterinary<br />

use<br />

8201 Mepidont 2 % z adrenalina˛<br />

1:100.000<br />

Epinephrinum +<br />

Mepivacainum<br />

Solution for injection (0,01mg +<br />

20mg)/ml<br />

AniMedica West Chemische<br />

Produkte GmbH<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

8202 Mepidont 3 % Mepivacainum Solution for injection 30 mg/ml L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

30/10/05<br />

20/07/06<br />

10/05/04<br />

31/12/08<br />

31/12/08<br />

31/07/04<br />

31/07/04<br />

8203 Mepivastesin Mepivacainum Solution for injection 30 mg/ml ESPE Dental AG 30/06/04<br />

8204 Mepron Atovaquonum Suspension Glaxo Wellcome House,<br />

Glaxo Wellcome Group<br />

8205 Mercaptopurinum Mercaptopurinum Tablets 50 mg VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

8206 Mercilon Desogestrelum +<br />

Ethinylestradiolum<br />

Tablets 0,15mg +<br />

0,02mg<br />

31/12/08<br />

31/12/05<br />

Organon Irlandia Ltd 30/04/05<br />

8207 Mercurialis Ointment WALA-Heilmittel GmbH 24/05/07<br />

8208 Mercurialis krople do oczu WALA-Heilmittel GmbH 31/08/05<br />

8209 Mercurius cyanatus complexe<br />

nr 43<br />

8210 Mercurius solubilis Complexe<br />

Lehning nr 39<br />

Drops Lehning Laboratoires 31/03/06<br />

Tablets Lehning Laboratoires 11/11/06<br />

8211 Mercurius-Heel S Sublingual tablets Heel GmbH 31/12/07<br />

8212 Meridia 10 Sibutraminum Capsules 10 mg Abbott GmbH & Co KG 31/03/04<br />

8213 Meridia 15 Sibutraminum Capsules 15 mg Abbott GmbH & Co KG 31/03/04<br />

8214 Merilym Szczepionka dla psów<br />

przeciw boreliozie<br />

Suspension for veterinary<br />

use<br />

8215 Merional Hp Gonadotropinum Lyophilisate for<br />

solution for infusion<br />

8216 Meronem Meropenemum Intramuscular<br />

injection<br />

8217 Meronem Meropenemum Powder for solution<br />

for injection<br />

8218 Meronem Meropenemum Powder for solution<br />

for injection<br />

8219 Merz Spezial Dragees Multivitamins and trace<br />

elements<br />

Rhone Merieux Laboratoire 31/12/08<br />

75 IU IBSA Institut Biochemique<br />

S.A.<br />

31/12/08<br />

0.5 g Zeneca Pharmaceuticals Ltd. 31/12/06<br />

1 g AstraZeneca UK Ltd. 8/01/06<br />

500 mg AstraZeneca UK Ltd. 8/01/06<br />

Coated tablets Merz & Co. GmbH 31/08/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1107<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8220 Mesalazyna Mesalazinum Suppository 250 mg Farmjug Sp. z o.o. 31/12/08<br />

8221 MESALAZYNA 250 mg Mesalazinum Suppository 250 mg Farmina Sp. z o.o. 31/12/08<br />

8222 Mesalin Estradiolu benzoesan Solution for veterinary<br />

use<br />

8223 MESENCHYM/CALCIUM<br />

CARB. comp. ampułki<br />

8224 M-Eslon Morphinum Prolonged release<br />

capsules<br />

8225 M-Eslon Morphinum Prolonged release<br />

capsules<br />

8226 M-Eslon Morphinum Prolonged release<br />

capsules<br />

8<strong>227</strong> M-Eslon Morphinum Prolonged release<br />

capsules<br />

8228 Mesporin 2000 Ceftriaxonum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

8229 Mesporin 250 Ceftriaxonum powder and solvent<br />

for solution for<br />

intramuscular<br />

injection<br />

8230 Mesporin 500 Ceftriaxonum powder and solvent<br />

for solution for<br />

intramuscular<br />

injection<br />

8231 MESPORIN® 1000 I.M. Ceftriaxonum powder and solvent<br />

for solution for<br />

intramuscular<br />

injection<br />

8232 MESPORIN® 1000 I.V. Ceftriaxonum Powder and solvent<br />

for solution for<br />

intravascular injection<br />

Intervet 31/12/08<br />

WALA-Heilmittel GmbH 19/03/05<br />

10 mg Ethypharm Industres 31/12/07<br />

100 mg Ethypharm Industres 31/12/07<br />

30 mg Ethypharm Industres 31/12/07<br />

60 mg Ethypharm Industres 31/12/07<br />

2 g Mepha L.D.A. 31/12/08<br />

250 mg Mepha L.D.A. 31/12/08<br />

500 mg Mepha L.D.A. 31/12/08<br />

1g Mepha L.D.A. 31/12/08<br />

1g Mepha L.D.A. 31/12/08<br />

8233 Mestinon Pyridostigminum Film-coated tablets 60 mg ICN Polfa Rzeszów S.A. 31/01/05<br />

8234 Mestinon Pyridostigminum Film-coated tablets 60 mg ICN Polfa Rzeszów S.A. 31/01/05<br />

8235 Mesulid Nimesulidum Granules for oral<br />

suspension<br />

100 mg CSC Pharmaceuticals Handels<br />

GmbH<br />

8236 Mesulid Nimesulidum Tablets 100 mg CSC Pharmaceuticals Handels<br />

GmbH<br />

31/12/08<br />

31/12/08<br />

8237 Metabol. Species metabolicae Herbal tea Eldex-Medical 31/12/06<br />

8238 Metabol-fix Instant herbal tea P.P.H. ‘Eldex-Medical’, Wiry 31/12/08<br />

8239 Metacam Meloxicanum Suspension for veterinary<br />

use<br />

8240 Metacam 20 mg Bydło Meloxicanum Solution for veterinary<br />

use<br />

8241 Metacam Bydło Meloxicanum Solution for veterinary<br />

use<br />

8242 Metacam Pies Meloxicanum Solution for veterinary<br />

use<br />

Boehringer Ingelheim<br />

Vetmedica GmbH<br />

8/11/05<br />

Boeringer Ingelheim 31/12/08<br />

Boehringer Ingelheim<br />

Vetmedica GmbH<br />

Boehringer Ingelheim<br />

Vetmedica GmbH<br />

14/11/05<br />

8/11/05


EN<br />

1108 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8243 Metafen Paracetamolum +<br />

Ibuprofenum<br />

Tablets 400 mg +<br />

200 mg<br />

Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

8244 Metaflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

8245 Metajodobenzyloguanidyna-<br />

123 I (MIBG- 123 I)<br />

8246 Metajodobenzyloguanidyna-<br />

- 131 I (MIBG- 131 I)<br />

Iobenguanum Solution for injection 92.5 MBq/<br />

5ml<br />

Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Iobenquanum Solution for injection Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

8247 Metalyse Tenecteplasum Powder and solvent<br />

for solution for<br />

injection<br />

8248 Metalyse Tenecteplasum Powder and solvent<br />

for solution for<br />

injection<br />

8249 Metalyse Tenecteplasum Powder and solvent<br />

for solution for<br />

injection<br />

6000 j (30 mg) Boehringer Ingelheim<br />

International GmbH<br />

8000 j (40 mg) Boehringer Ingelheim<br />

International GmbH<br />

10000 j<br />

(50 mg)<br />

Boehringer Ingelheim<br />

International GmbH<br />

31/12/08<br />

30/04/05<br />

25/01/06<br />

25/01/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

8250 Metamizol sodowy A.C.E.F., Włochy 31/12/08<br />

8251 Metamizol sodowy Farm-Impex s.j., Gliwice 31/12/08<br />

8252 Metamizol sodowy Pharma Cosmetic, Kraków 31/12/08<br />

8253 Metamizol sodowy PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

8254 Metamucil Citrus Plantaginis ovatae testa Powder for oral<br />

suspension<br />

8255 Metamucil Orange Plantaginis ovatae testa Powder for oral<br />

suspension<br />

31/12/08<br />

3.29 g Searle Pharmaceuticals 31/07/05<br />

3.29 g Searle Pharmaceuticals 31/07/05<br />

8256 Metanabol Metandienonum Cream 5 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8257 Metanabol Metandienonum Tablets 1 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8258 Metanabol Metandienonum Tablets 5 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8259 Metastron Solution for<br />

intravenous injection<br />

8260 Metawetrim Sulfadymidyna,<br />

Trimetoprim<br />

Powder for veterinary<br />

use<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

Nycomed Amersham plc 15/03/06<br />

Grodziskie Zakłady<br />

Farmaceutyczne Polfa<br />

8261 Metazydyna Trimetazidinum Film-coated tablets 20 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

8262 Metazydyna Mr Trimetazidinum Modified release<br />

tablets<br />

35 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

8263 Metenamina BUFA b.v. Pharmaceutical<br />

Products<br />

8264 Metenamina Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

30/06/04<br />

14/12/05<br />

31/12/08<br />

19/01/05<br />

19/01/05<br />

8265 Metenamina Pharma Cosmetic, Kraków 19/01/05<br />

8266 Metenamina Pharma Zentrale 19/01/05<br />

8267 Metenamina PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

19/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1109<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8268 Meteoreisen/Phosphor/Quarz<br />

granulki<br />

8269 Meteoreisen/Phosphor/Quarz<br />

inj.<br />

8270 Meteospasmyl Alverinum +<br />

Dimeticonum<br />

WALA-Heilmittel GmbH 31/08/05<br />

WALA-Heilmittel GmbH 31/08/05<br />

Capsules Mayoly Spindler Laboratoires 26/04/06<br />

8271 Metfogamm 500 Metforminum Film-coated tablets 500 mg Wörwag Pharma GmbH Co.<br />

KG<br />

8272 Metfogamma 850 Metforminum Film-coated tablets 850 mg Wörwag Pharma GmbH Co.<br />

KG<br />

8273 Metforatio 500 Metformini<br />

hydrochloridum<br />

8274 Metforatio 850 Metformini<br />

hydrochloridum<br />

8275 Metformax 500 Metformini<br />

hydrochloridum<br />

31/12/08<br />

31/12/08<br />

Film-coated tablets 500 mg ratiopharm GmbH 31/08/05<br />

Film-coated tablets 850 mg ratiopharm GmbH 31/08/05<br />

Tablets 500 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8276 Metformax 500 Mr Metforminum Tablets 500 mg Kutnowskie Zakłady<br />

Farmaceutyczne Polfa Kutno<br />

S.A.<br />

8277 Metformax 850 Metformini<br />

hydrochloridum<br />

8278 Metformin Metformini<br />

hydrochloridum<br />

8279 Metformin Metforminum Tablets 500 mg ;<br />

850 mg<br />

Tablets 850 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tablets 500 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

8280 Metformin Metforminum Tablets 500 mg Chemiczno —<br />

Farmaceutyczna Spółdzielnia<br />

Pracy ESPEFA<br />

8281 Metformin 850 Metformini<br />

hydrochloridum<br />

Tablets 850 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

8282 Metformina Anpharm Metforminum Film-coated tablets 850 mg Przedsie˛biorstwo<br />

Farmaceutyczne Anpharm<br />

S.A.<br />

8283 Methadone hydrochloride Methadonum Syrup 0.1 g/100 ml L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

8284 Methadone hydrochloride Methadonum Syrup 1 mg/ml L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

8285 Methadone hydrochloride Methadonum Syrup 10 mg/10 ml L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

8286 Methadone hydrochloride Methadonum Syrup 20 mg/20 ml L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

8287 Methadone hydrochloride Methadonum Syrup 60 mg/60 ml L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

8288 METHADONE<br />

HYDROCHLORIDE Pulvis<br />

31/12/05<br />

31/12/08<br />

31/05/06<br />

31/01/05<br />

31/12/08<br />

31/12/08<br />

17/01/07<br />

31/12/08<br />

31/12/08<br />

30/06/07<br />

31/12/08<br />

31/12/07<br />

31/12/08<br />

Methadonum Bufa B.V. 31/12/08<br />

8289 Methimazol Thiamazolum Tablets 5 mg M. Philopharm 31/12/08<br />

8290 Methiovit Film-coated tablets Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05


EN<br />

1110 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8291 Methocarbamol Methocarbamolum Tablets 500 mg Espefa Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

8292 Methocel Hypromellosum Eye drops 20 mg/ml Novartis Ophthalmics AG<br />

Hettlingen<br />

8293 Methotrexaet-Teva Methotrexatum Vial 50 mg/2 ml Teva Pharmaceutical<br />

Industries<br />

8294 Methotrexat Methotrexatum Lyophilisate for<br />

solution for injection<br />

8295 Methotrexat Methotrexatum Lyophilisate for<br />

solution for injection<br />

31/12/05<br />

31/07/04<br />

31/12/08<br />

1000 mg PLIVA — LACHEMA a.s. 31/05/04<br />

50 mg PLIVA — LACHEMA a.s. 31/05/04<br />

8296 Methotrexat Methotrexatum Solution for injection 500 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

8297 Methotrexat Methotrexatum Solution for injection 10 mg/ml PLIVA — LACHEMA a.s. 31/05/04<br />

8298 Methotrexat Methotrexatum Solution for injection 2.5 mg/ml PLIVA — LACHEMA a.s. 31/05/04<br />

8299 Methotrexat Methotrexatum Solution for injection 50 mg/ml PLIVA — LACHEMA a.s. 31/05/04<br />

8300 Methotrexat Methotrexatum Tablets 10 mg PLIVA — LACHEMA a.s. 31/05/04<br />

8301 Methotrexat Methotrexatum Tablets 2.5 mg PLIVA — LACHEMA a.s. 31/05/04<br />

8302 Methotrexate Methotrexatum Amp. 50 mg/2 ml Teva Pharmaceutical<br />

Industries<br />

23/11/05<br />

8303 Methotrexate Methotrexatum Solution 5 mg THISSEN Laboratoires 31/12/08<br />

8304 Methotrexate Methotrexatum Solution 25 mg THISSEN Laboratoires 31/12/08<br />

8305 Methotrexate Methotrexatum Solution 50 mg THISSEN Laboratoires 31/12/08<br />

8306 Methotrexate Methotrexatum Solution 500 mg THISSEN Laboratoires 31/12/08<br />

8307 Methotrexate Methotrexatum Solution for injection 25 mg/ml Pharmacia Upjohn Pty Ltd.<br />

Bentley<br />

23/11/05<br />

8308 Methotrexate Therabel Methotrexatum Injection 50 mg/ml Laboratoires Thissen 31/12/08<br />

8309 Methotrexat-Ebewe Methotrexatum Solution for injection 100 mg/ml EBEWE Arzneimittel GmbH 31/01/05<br />

8310 Methotrexat-Ebewe,<br />

Metotreksat-Knoll<br />

8311 Methotrexat-Ebewe,<br />

Metotreksat-Knoll<br />

8312 Methotrexat-Ebewe,<br />

Metotreksat-Knoll 10<br />

8313 Methotrexat-Ebewe,<br />

Metotreksat-Knoll 2,5<br />

8314 Methotrexat-Ebewe,<br />

Metotreksat-Knoll 5<br />

Methotrexatum Solution for injection 10 mg/ml EBEWE Arzneimittel GmbH 31/01/05<br />

Methotrexatum Solution for injection 5 mg/ml EBEWE Arzneimittel GmbH 31/01/05<br />

Methotrexatum Tablets 10 mg EBEWE Arzneimittel GmbH 31/12/04<br />

Methotrexatum Tablets 2.5 mg EBEWE Arzneimittel GmbH 31/12/04<br />

Methotrexatum Tablets 5 mg EBEWE Arzneimittel GmbH 31/12/04<br />

8318 Methotrexate-Teva Methotrexatum Intravenous infusion 16 mg/40 ml Teva Pharmaceutical<br />

Industries<br />

8315 Methotrexate-Teva Methotrexatum Vial 200 mg/8 ml Teva Pharmaceutical<br />

Industries<br />

8316 Methotrexate-Teva Methotrexatum Vial 500 mg/20 ml Teva Pharmaceutical<br />

Industries<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1111<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8317 Methotrexate-Teva Methotrexatum Vial 100 mg/4 ml Teva Pharmaceutical<br />

Industries<br />

8320 Methotrexatum Methotrexatum Liquid for injection 20 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8321 Methotrexatum Methotrexatum Lyophilisated<br />

substance<br />

500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8319 Methotrexatum Methotrexatum Lyophylisate 50 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8322 Methotrexatum Methotrexatum Tablets 2,5 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8323 Methoxasol Trimethoprinum +<br />

Sulphametoxasolum<br />

Solution for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Eurovet 31/12/08<br />

8324 Methyldopa Methyldopum Tablets 250 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

8325 Methylergometrin Methylergometrinum Solution for injection 0.2 mg/1 ml Spofa a.s. 30/06/05<br />

8326 Methylthiouracilum Methylthiouracilum Coated tablets 100 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

8327 Metifor Metformini<br />

hydrochloridum<br />

31/01/06<br />

Tablets 500 mg Polfarmex S.A 31/12/08<br />

8328 Metifor Metforminum Tablets 850 mg Polfarmex S.A. 31/12/08<br />

8331 Metindol Indometacinum Film-coated tablets 25 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8329 Metindol Indometacinum Ointment 50 mg/g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

8330 Metindol Indometacinum Solution for injection 30 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

8332 Metindol Retard Indometacinum Prolonged release<br />

tablets<br />

8333 Metindonium Cetrimonii bromidum +<br />

Indometacinum<br />

30/01/05<br />

31/12/05<br />

31/12/05<br />

75 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

Oromucosal solution Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/05<br />

8334 Metizol Thiamazolum Tablets 5 mg ICN Polfa Rzeszów S.A. 31/12/05<br />

8335 Metocard Metoprololi tartas Tablets 100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

8336 Metocard Metoprololi tartas Tablets 50 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

8337 Metocard prolongatum Metoprololi tartas Prolonged release<br />

tablets<br />

200 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

8338 Metoclopramid 10 Metoclopramidum Suppository 10 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

8339 Metoclopramid 20 Metoclopramidum Suppository 20 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

8340 Metoclopramidum Metoclopramidum Solution for injection 5 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

8341 Metoclopramidum Metoclopramidum Tablets 10 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

8342 Metohexal 50 Metoprololi tartas Tablets 50 mg Hexal AG 31/12/08<br />

8343 Metohexal 100 Metoprololi tartas Tablets 100 mg Hexal AG 31/12/08


EN<br />

1112 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8344 Metohexal 200 retard Metoprololi tartas Prolonged release<br />

tablets<br />

200 mg Hexal AG 25/04/07<br />

8345 Metoprolol Metoprololi tartas Tablets 100 mg ICN Polfa Rzeszów S.A. 31/10/05<br />

8346 Metoprolol Metoprololi tartas Tablets 50 mg ICN Polfa Rzeszów S.A. 31/10/05<br />

8347 Metoprolol Metoprololum Tablets 50 mg Aflofarm 31/12/08<br />

8348 Metoxan Oxymetazolum Nasal spray 0,05 % US Pharmacia 31/12/08<br />

8349 Metral Metforminum Tablets 500 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

8350 Metral Metforminum Tablets 850 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

8351 Metricure Cefapiryna Suspension for veterinary<br />

use<br />

8352 Metrihex Chlorhexidinum Intrauterine stick for veterinary<br />

use<br />

8353 Metrisan AN Ampicillinum +<br />

Neomycinum<br />

Suspension for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

Intervet 31/12/08<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

17/08/04<br />

Vet-Agro 31/12/08<br />

8354 Metro-Adnex-Injeel Amp. Heel GmbH 31/12/08<br />

8355 Metrodin Urofollitropinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

8356 Metrodin HP Urofollitropinum Lyophilisate and<br />

solvent for solution<br />

for intramuscular or<br />

subcutaneous<br />

injection<br />

75 j.m. (FSH) Ares-Serono International<br />

S.A.<br />

75 j.m./ml Industria Farmaceutica<br />

Serono<br />

8359 Metronidazol Metronidazolum Cream 10 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8363 Metronidazol Metronidazolum Gel Laboratorium Galenowe<br />

‘LEFARM’ Sp. z o.o.<br />

8364 Metronidazol Metronidazolum Gel 10 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8360 Metronidazol Metronidazolum Oromucosal paste 100 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8357 Metronidazol Metronidazolum Suppository 1 g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

8358 Metronidazol Metronidazolum Suppository 500 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

8361 Metronidazol Metronidazolum Tablets 250 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

8362 Metronidazol Metronidazolum Vaginal tablets 500 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/08/04<br />

31/08/04<br />

30/10/05<br />

9/01/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/04/04<br />

31/12/05<br />

31/12/05<br />

8365 Metronidazol Farm-Impex s.j., Gliwice 9/01/05<br />

8366 Metronidazol Pharma Cosmetic, Kraków 9/01/05<br />

8367 Metronidazol Pharma Zentrale 9/01/05<br />

8368 Metronidazol PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

9/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1113<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8369 Metronidazol 0,5 % Metronidazolum Solution for<br />

intravenous infusion<br />

8370 Metronidazol 0,5 % Metronidazolum Solution for<br />

intravenous injection<br />

and intravenous<br />

infusion<br />

8371 Metronidazol 20 % Metronidazolum Powder for veterinary<br />

use<br />

8372 Metronidazolum 20 % Metronidazolum Powder for veterinary<br />

use<br />

5 mg/ml Fresenius Kabi Polska Sp. z<br />

o.o.<br />

5 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/12/05<br />

31/12/05<br />

Vetos-Farma 31/12/08<br />

Interbiowet Sp z o.o. 22/11/06<br />

8373 Metronigem Metronidazolum Cream 10 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

31/12/08<br />

8374 Metrosept Metronidazolum Gel 7.5 mg/g ICN Polfa Rzeszów S.A. 25/10/06<br />

8375 Metylu hydroksybenzoesan Caesar & Loretz GmbH Caelo 31/08/05<br />

8376 Metylu salicylan Zakłady Farmaceutyczne<br />

Polpharma SA, Starogard<br />

Gdański<br />

19/11/07<br />

8377 Metypred Methylprednisolonum Tablets 16 mg Orion Corporation 30/01/05<br />

8378 Metypred Methylprednisolonum Tablets 4 mg Orion Corporation 30/01/05<br />

8379 Mevacor Lovastatinum Tablets 20 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

8380 Mexicord Mexiletinum Capsules 200 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

8381 Mexitil Mexiletinum Capsules 200 mg Boehringer Ingelheim<br />

International GmbH<br />

8382 Mexitil Mexiletinum Capsules 50 mg Boehringer Ingelheim<br />

International GmbH<br />

8383 Mexitil Mexiletinum Solution for injection 25 g/ml Boehringer Ingelheim<br />

International GmbH<br />

8384 Mexitil Depot 360 mg Mexiletinum Prolonged release<br />

capsules<br />

360 mg Boehringer Ingelheim<br />

International GmbH<br />

30/06/04<br />

30/11/05<br />

31/05/04<br />

31/05/04<br />

31/05/04<br />

31/05/04<br />

8385 Mezereum Ointment Laboratoires BOIRON 9/12/06<br />

8386 Mezereum-Homaccord Amp. Heel GmbH 31/12/07<br />

8387 Mezereum-Homaccord Drops Heel GmbH 31/12/07<br />

8388 Miacalcic Calcitoninum salmonis Solution for injection 100 j.m./ml Novartis Pharma AG 31/05/04<br />

8389 Miacalcic Calcitoninum salmonis Solution for injection 50 j.m./ml Novartis Pharma AG 31/05/04<br />

8390 Miacalcic Nasal 200 Calcitoninum salmonis Nasal spray 200 j.m./dawke˛ Novartis Pharma AG 31/12/08<br />

8391 Miansemerck 10 Mianserinum Film-coated tablets 10 mg Generics (UK) Limited 24/05/06<br />

8392 Miansemerck 30 Mianserinum Film-coated tablets 30 mg Generics (UK) Limited 24/05/06<br />

8394 Mianserin Mianserinum Film-coated tablets 30 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

8393 Mianserin Mianserinum Film-coated tablets 10 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8395 Mibalin Methylthioninii<br />

chloridum +<br />

Naphazolinum<br />

Eye drops, solution (0,5mg +<br />

0,2mg)/ml<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

31/12/08<br />

31/12/05


EN<br />

1114 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8396 Mibd (131 I) Injection Preparat<br />

radiofarmaceutyczny<br />

Mallinckrodt Medical B.V. 31/12/08<br />

8397 Micardis Telmisartanum Tablets 20 mg Boehringer Ingelheim<br />

International GmbH<br />

8398 Micardis Telmisartanum Tablets 40 mg Boehringer Ingelheim<br />

International GmbH<br />

8399 Micardis Telmisartanum Tablets 80 mg Boehringer Ingelheim<br />

International GmbH<br />

8400 Micardis Plus Telmisartanum +<br />

Hydrochlorothiazidum<br />

8401 Micardis Plus Telmisartanum +<br />

Hydrochlorothiazidum<br />

Tablets 40 mg +<br />

12,5 mg<br />

Tablets 80 mg +<br />

12,5 mg<br />

Boehringer Ingelheim<br />

International GmbH<br />

Boehringer Ingelheim<br />

International GmbH<br />

6/12/06<br />

31/10/04<br />

31/10/04<br />

31/12/08<br />

31/12/08<br />

8402 Micetal Flutrimazolum Cream 10 mg/g J.Uriach&cia S.A. 31/12/04<br />

8403 Micetal Flutrimazolum Cutaneous spray,<br />

solution<br />

10 mg/ml J.Uriach&cia S.A. 31/12/04<br />

8404 Micetal Flutrimazolum Gel 10 mg/g J.Uriach&cia S.A. 31/12/04<br />

8405 Miconal Miconazolum Gel 2 % Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8406 Miconal Miconazolum Gel 20 mg/g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8407 Micotil 300 Tylmikozyna Solution for veterinary<br />

use<br />

8408 Microgynon 21 Ethinylestradiolum +<br />

Levonorgestrelum<br />

Eli Lilly Regional Operations<br />

Ges.m.b.H c/o Elanco Animal<br />

Health<br />

31/12/08<br />

14/02/07<br />

21/02/06<br />

Film-coated tablets Schering AG 30/04/04<br />

8409 Microser Betahistinum Tablets 8 mg Prodotti Formenti S.r.l 31/05/05<br />

8410 Midanium Midazolamum Solution for injection 1 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8411 Midanium Midazolamum Solution for injection 5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8412 Midazolam 1 mg/ml Torrex Midazolamum Solution for injection 1 mg/ml;<br />

opakowanie<br />

2ml<br />

8413 Midazolam 1 mg/ml Torrex Midazolamum Solution for injection 1 mg/ml;<br />

opakowanie<br />

5ml<br />

8414 Midazolam 1 mg/ml Torrex Midazolamum Solution for injection 1 mg/ml;<br />

opakowanie<br />

10 ml<br />

8415 Midazolam 5 mg/ml Torrex Midazolamum Solution for injection 5 mg/ml;<br />

opakowanie<br />

1ml<br />

8416 Midazolam 5 mg/ml Torrex Midazolamum Solution for injection 5 mg/ml;<br />

opakowanie<br />

3ml<br />

8417 Midazolam 5 mg/ml Torrex Midazolamum Solution for injection 5 mg/ml;<br />

opakowanie<br />

5ml<br />

28/02/06<br />

28/02/06<br />

Torrex Pharma GmbH 31/12/08<br />

Torrex Pharma GmbH 31/12/08<br />

Torrex Pharma GmbH 31/12/08<br />

Torrex Pharma GmbH 31/12/08<br />

Torrex Pharma GmbH 31/12/08<br />

Torrex Pharma GmbH 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1115<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8418 Midazolam 5 mg/ml Torrex Midazolamum Solution for injection 5 mg/ml;<br />

opakowanie<br />

10 ml<br />

8419 Midazolam 5 mg/ml Torrex Midazolamum Solution for injection 5 mg/ml;<br />

opakowanie<br />

18 ml<br />

Torrex Pharma GmbH 31/12/08<br />

Torrex Pharma GmbH 31/12/08<br />

8420 Miedzi siarczan Pharma Cosmetic, Kraków 31/12/08<br />

8421 Miedziowy siarczan Pharma Zentrale 14/02/05<br />

8422 Miflonide Budesonidum Inhalation powder,<br />

capsules<br />

8423 Miflonide Budesonidum Inhalation powder,<br />

capsules<br />

200 mcg Novartis Pharmaceuticals UK<br />

Ltd<br />

400 mcg Novartis Pharmaceuticals UK<br />

Ltd<br />

14/02/07<br />

14/02/07<br />

8424 Migea Acidum tolfenamicum Tablets 200 mg A/S GEA Farmaceutisk Fabrik 27/06/07<br />

8425 Migpriv Acidum acetylsalicylicum<br />

+ Metoclopramidum<br />

8426 Migralgan Carbasalatum calcium +<br />

Metoclopramidum<br />

8427 Migranolina Paracetamolum +<br />

Codeinum + Buclizini<br />

hydrochloridum<br />

Powder for oral<br />

solution<br />

Effervescent powder<br />

for oral solution<br />

1620mg +<br />

10mg<br />

Synthelabo Group.<br />

Laboratoires Synthelabo<br />

25/01/06<br />

UPSA Laboratoires Agen 17/01/07<br />

Film-coated tablets Medana Pharma TERPOL<br />

Group S.A.<br />

31/12/08<br />

8428 Migrenol Coutanous liquid Sanofi-Synthelabo Sp. z o.o. 30/10/05<br />

8429 Migril Sumatriptanum Film-coated tablets 50 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

8430 Migril Sumatriptanum Film-coated tablets 100 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/12/08<br />

31/12/08<br />

8431 Mikonazol Miconazoli nitras Cream 2 % Instytut Farmaceutyczny 31/12/07<br />

8432 Mikonazol Miconazoli nitras Cream 20 mg/g ICN Polfa Rzeszów S.A. 25/10/06<br />

8433 Mikonazol Miconazolum Cream 2 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

8434 Mikrosol B-compositum Witaminy z grupy B,<br />

witamina K3,<br />

witamina C, amid<br />

kwasu nikotynowego,<br />

pantotenian wapnia<br />

Powder for veterinary<br />

use<br />

8435 Mikrosol E Witamina E Powder for veterinary<br />

use<br />

Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

14/06/04<br />

14/06/04<br />

8436 Miksaj Atorvastatinum Film-coated tablets 0,4 mg Instytut Farmaceutyczny 31/12/08<br />

8437 Milgamma 100 Benfothiaminum +<br />

Pyridoxinum<br />

8438 Milgamma N Thiaminum +<br />

Pyridoxinum +<br />

Cyanocobalaminum<br />

Film-coated tablets 100 mg B1 +<br />

100 mg B6<br />

Solution for injection (50 mg +<br />

50 mg +<br />

0,5 mg)/ml<br />

Wörwag Pharma GmbH Co.<br />

KG<br />

Wörwag Pharma GmbH Co.<br />

KG<br />

8439 Milmag Magnesii hydroxidum Suspension 8 % Polon — Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

8440 Milocardin Preparat złoz˙ony Oral drops Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/12/08<br />

31/12/08<br />

31/12/06<br />

30/10/05


EN<br />

1116 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8441 Miloxan Szczepionka dla bydła<br />

I owiec przeciwko<br />

zakaz˙eniom<br />

toksynotwórczymi<br />

bakteriami<br />

beztlenowymi z<br />

rodzaju clostridium<br />

Suspension for veterinary<br />

use<br />

Merial 31/12/08<br />

8442 Miltex Miltefosinum Solution 60 mg/ml Asta Medica AG 31/12/08<br />

8443 Milupa PKU 1 Dieta w fenyloketonurii Granules Milupa GmbH and Co. KG 11/10/06<br />

8444 MILUPA PKU 1 — Mix Dieta Granules Milupa GmbH & Co. KG 31/12/08<br />

8445 Milupa PKU 2 Dieta w fenyloketonurii Granules Milupa GmbH and Co. KG 15/03/06<br />

8446 Milupa PKU 3 Dieta w fenyloketonurii Granules Milupa GmbH and Co. KG 15/03/06<br />

8447 Milurit Allopurinolum Tablets 100 mg Egis Pharmaceuticals Ltd. 30/06/04<br />

8448 Milurit Allopurinolum Tablets 300 mg Egis Pharmaceuticals Ltd. 30/06/04<br />

8449 Milvane Ethinylestradiolum +<br />

Gestodenum<br />

Film-coated tablets Schering AG 30/09/04<br />

8450 Minadex Preparat złoz˙ony Oral emulsion Seven Seas Ltd. 31/12/08<br />

8451 Minaflex Dieta Powder for oral<br />

solution<br />

8452 MINAFLEX O Smaku<br />

Waniliowo — Ananasowym<br />

Dieta Powder for oral<br />

solution<br />

SHS International Ltd. 31/12/08<br />

SHS International Ltd. 31/12/08<br />

8453 Minallvit Preparat złoz˙ony Buccal tablet Carls-Bergh Pharma ab 30/06/04<br />

8454 Minerasol Micro and macro<br />

elements<br />

8455 Minesse Ethinylestradiolum +<br />

Gestodenum<br />

8456 Minesulin Nimesulidum Powder for oral<br />

suspension<br />

Solution for veterinary<br />

use<br />

Film-coated tablets 0,15mg +<br />

0,06mg<br />

Richter Pharma 11/03/04<br />

Wyeth-Lederle Pharma GmbH 9/08/06<br />

100 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

8457 Minesulin Nimesulidum Tablets 100 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

31/12/08<br />

8458 Miniderm Acidum salicylicum Pach 400 mg/g 3M VISCOPLAST S.A. 31/08/05<br />

8459 Minidiab Glipizidum Tablets 5 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

8460 Minipress Prazosinum Tablets 1 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

8461 Minipress Prazosinum Tablets 2 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

8462 Minipress Prazosinum Tablets 5 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

8464 Minirin Desmopressinum Nasal drops, solution 0.1 mg/ml Ferring AB 31/08/05<br />

8463 Minirin Desmopressinum Nasal spray 10 mcg/dawke˛<br />

donosowa˛<br />

Ferring AB 6/07/05<br />

8465 Minirin Desmopressinum Solution for injection 4 mcg/ml Ferring AB 31/08/05<br />

8466 Minirin 0,1 Desmopressinum Tablets 0.1 mg Ferring AB 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1117<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8467 Minirin 0,2 Desmopressinum Tablets 0.2 mg Ferring AB 31/12/08<br />

8468 Minisiston Ethinylestradiolum +<br />

Levonorgestrelum<br />

Coated tablets Jenapharm GmbH & Co. 30/04/04<br />

8469 MINITRAN 10 mg Glyceroli trinitras Transdermal pach 3 M MEDICA 31/12/08<br />

8470 MINITRAN 5 mg Glyceroli trinitras Transdermal pach 3 M MEDICA 31/12/08<br />

8471 Minivita Multivitamins and trace<br />

elements<br />

Buccal tablet Puritan's Pride, Incorporated 31/07/04<br />

8472 Minolest Sanacare 31/12/08<br />

8473 Minulet Ethinylestradiolum +<br />

Gestodenum<br />

Coated tablets 0,3mg +<br />

0,75mg<br />

Wyeth-Lederle Pharma GmbH 30/04/04<br />

8475 Miocamen Miocamycinum Film-coated tablets 600 mg A. Menarini Industrie<br />

Farmaceutische Riunite S.R.L.<br />

8474 Miocamen Miocamycinum Granules for oral<br />

solution<br />

8476 Miostat Carbacholum Solution for<br />

intraocular use<br />

6 g A. Menarini Industrie<br />

Farmaceutische Riunite S.R.L.<br />

31/12/08<br />

31/12/08<br />

0.1 mg/ml Alcon Laboratoires Inc Texas 30/04/04<br />

8477 miód cebulowy Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

8478 Miód prawos´lazowy Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

8479 Mirapexin Pramipexolum Tablets 0.088 mg Pharmacia & Upjohn S.A. —<br />

Luxemburg<br />

8480 Mirapexin Pramipexolum Tablets 0.18 mg Pharmacia & Upjohn S.A. —<br />

Luxemburg<br />

8481 Mirapexin Pramipexolum Tablets 0.7 mg Pharmacia & Upjohn S.A. —<br />

Luxemburg<br />

31/12/08<br />

31/12/08<br />

30/04/05<br />

30/04/05<br />

30/04/05<br />

8482 Miraspryn Acidum acetylsalicylicum Tablets 0.325 g Time-Cap Laboratories Ltd. 31/12/07<br />

8483 Mirelle Ethinylestradiolum +<br />

Gestodenum<br />

Film-coated tablets Schering AG 9/08/06<br />

8484 Mirenil Fluphenazinum Coated tablets 0.25 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8485 Mirenil Fluphenazinum Coated tablets 1 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8486 Mirenil Prolongatum Fluphenazinum Solution for injection 25 mg/1 ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8487 Miro Szampon przeciw<br />

pchłom i kleszczom dla psa<br />

Tetrametryna Liquid for veterinary<br />

use<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

Laboratoires ICC 31/12/08<br />

8488 Mirtal Mirtazapinum Film-coated tablets 30 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

8489 Mirtal Mirtazapinum Film-coated tablets 45 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/12/08<br />

31/12/08<br />

8490 Mirtazapin Mirtazapinum Film-coated tablets 45 mg POLFA KUTNO S.A. 31/12/08<br />

8491 Mirtazapin Mirtazapinum Film-coated tablets 30 mg POLFA KUTNO S.A. 31/12/08<br />

8492 Mirtazapina Mirtazapinum Film-coated tablets 30 mg POL-NIL Sp. z.o.o. 31/12/08<br />

8493 Mirtazapina Mirtazapinum Film-coated tablets 45 mg POL-NIL Sp. z.o.o. 31/12/08


EN<br />

1118 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8496 Mistabron Mesnum Inhalation liquid and<br />

for endotracheopulmonary<br />

and<br />

bronchial instillation<br />

200 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/11/05<br />

8495 Mistabron Mesnum Inhalation solution 200 mg/ml UCB S.A. Pharma Sector 30/06/04<br />

8494 Mistabron Mesnum Nasal spray, solution 50 mg/ml GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

8497 Mitomycin C Mitomycinum Lyophilisate for<br />

solution for injection<br />

8498 Mitomycin C Mitomycinum Lyophilisate for<br />

solution for injection<br />

8499 Mitomycin C Mitomycinum Lyophilisate for<br />

solution for injection<br />

31/12/05<br />

10 mg Kyowa Hakko 31/05/04<br />

2 mg Kyowa Hakko 31/05/04<br />

20 mg Kyowa Hakko 31/05/04<br />

8500 Mitoxantrone Mitoxantronum Solution for injection 2 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8501 Mivacron Mivacurii chloridum Solution for<br />

intravenous injection<br />

8502 Miwana Natrii chloridi 0.9 %<br />

aerozol do nosa<br />

8503 Mixtard 10 HM Penfill Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8504 Mixtard 10 NovoLet Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8505 Mixtard 20 HM Penfill Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8506 Mixtard 20 NovoLet Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8507 Mixtard 30 NovoLet Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8508 Mixtard 30 HM Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8509 Mixtard 30 HM Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8510 Mixtard 30 HM Penfill Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8511 Mixtard 30 Innolet Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8512 MIXTARD 30 MC 100 J.M./Ml Isophanum insulinum<br />

biphasicum<br />

8513 MIXTARD 30 MC 40 J.M./Ml Isophanum insulinum<br />

biphasicum<br />

8514 Mixtard 40 HM Penfill Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8515 Mixtard 40 NovoLet Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8516 Mixtard 50 HM Penfill Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

2 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

30/11/05<br />

25/10/05<br />

MIWANA 30/09/05<br />

100 j.m./ml Novo Nordisk A/S 30/06/05<br />

100 j.m./ml Novo Nordisk A/S 8/01/06<br />

100 j.m./ml Novo Nordisk A/S 30/06/05<br />

100 j.m./ml Novo Nordisk A/S 8/01/06<br />

100 j.m./ml Novo Nordisk A/S 8/01/06<br />

100 j.m./ml Novo Nordisk A/S 31/07/04<br />

40 j.m./ml Novo Nordisk A/S 31/07/04<br />

100 j.m./ml Novo Nordisk A/S 31/07/04<br />

100 j.m./ml Novo Nordisk A/S 5/07/06<br />

100 j.m./ml Novo Nordisk A/S 31/12/08<br />

40 j.m./ml Novo Nordisk A/S 31/12/08<br />

100 j.m./ml Novo Nordisk A/S 30/06/05<br />

100 j.m./ml Novo Nordisk A/S 8/01/06<br />

100 j.m./ml Novo Nordisk A/S 30/06/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1119<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8517 Mixtard 50 NovoLet Insulini injectio neutralis<br />

+ Insulinum isophanum<br />

8518 Mixtura Pepsini Acidum hydrochloricum<br />

+ Pepsinum<br />

Suspension for<br />

injection<br />

100 j.m./ml Novo Nordisk A/S 8/01/06<br />

Oral solution Pampa — Laboratorium<br />

Farmaceutyczno-Kosmetyczne<br />

8519 Mizodin Primidonum Tablets 250 mg Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

30/06/07<br />

31/01/06<br />

8520 Mizolastatyna Atorvastatinum Film-coated tablets 10 mg Instytut Farmaceutyczny 31/12/08<br />

8521 Mizollen Mizolastinum Film-coated tablets 10 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

8522 Młode Pe˛dy Sosny Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

8523 M-M-R II Vaccinum morbillorum,<br />

parotitidis et rubellae<br />

vivum<br />

Lyophilisate and solvent for solution for<br />

subcutaneous injection<br />

Merck Sharp & Dohme Idea<br />

Inc.<br />

8524 Mobemid Moclobemidum Film-coated tablets 150 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

8526 Mobilat Gel Sankyo Pharma GmbH —<br />

München<br />

8525 Mobilat Ointment Sankyo Pharma GmbH —<br />

München<br />

31/10/04<br />

30/10/05<br />

31/12/04<br />

27/06/07<br />

30/04/04<br />

30/04/04<br />

8527 Moclobemid Torrex Moclobemide Film-coated tablets 150 mg Torrex Pharma GmbH 31/12/08<br />

8528 Moclobemid Torrex Moclobemide Film-coated tablets 300 mg Torrex Pharma GmbH 31/12/08<br />

8529 Mocloxil Moclobemidum Tablets 150 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8530 Mocznik BUFA b.v. Pharmaceutical<br />

Products<br />

8531 Mocznik Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

30/06/06<br />

31/01/06<br />

31/01/06<br />

8532 Mocznik Pharma Cosmetic, Kraków 31/01/06<br />

8533 Mocznik Pharma Zentrale 31/01/06<br />

8534 Mocznik Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

8535 Mocznik PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

8536 Modafen Ibuprofenum +<br />

Pseudoephedrinum<br />

31/01/06<br />

31/01/06<br />

Film-coated tablets Lečiva a.s. 29/08/07<br />

8537 Moderan Ibuprofenum Capsules, hard 300 mg US Pharmacia 31/12/08<br />

8538 Modifilan Tablets Innowacyjny Fundusz<br />

Sachalina<br />

8539 Modustatine Somatostatinum Lyophilisate for<br />

injection<br />

0.25 mg Sanofi Winthrop-Gentilly<br />

Cedex<br />

31/12/08<br />

31/12/08<br />

8540 Moflox Moxifloxacinum Film-coated tablets 400 mg Bioton Sp. z o.o. 31/12/08<br />

8541 Moklar Moclobemidum Film-coated tablets 150 mg Biovena Pharma Sp z o.o. 6/06/07<br />

8542 Molipsor R Molsidominum Film-coated tablets 8 mg IPSOR 31/12/08


EN<br />

1120 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8543 Molsidomina Molsidominum Tablets 2 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8544 Molsidomina Molsidominum Tablets 4 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8545 Molsidomina prolongatum Molsidominum Prolonged release<br />

tablets<br />

8 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

8546 Molsidomine Molsidominum Tablets 4 mg Aflofarm 31/12/08<br />

8547 Molsidomine Molsidominum Tablets 2 mg Aflofarm 31/12/08<br />

8548 Molybdan Compositum Tablets Heel GmbH 31/12/08<br />

8549 Mometazon Mometasoni furoas Cream 0,10 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

8551 Mometazon Mometasoni furoas Liquid 1mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

8550 Mometazon Mometasoni furoas Ointment 1 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

8552 Momordica Complexe Nr 109 Drops Lehning Laboratoires 31/12/08<br />

8553 Momordica compositum Amp. Heel GmbH 31/12/08<br />

8554 Monarc-M Coagulation factor VIII Lyophilisate and<br />

solvent for solution<br />

for intravascular<br />

injection and<br />

intravascular infusion<br />

8555 Monarc-M Coagulation factor VIII Lyophilisate and<br />

solvent for solution<br />

for intravascular<br />

injection and<br />

intravascular infusion<br />

8556 Monarc-M Coagulation factor VIII Lyophilisate and<br />

solvent for solution<br />

for intravascular<br />

injection and<br />

intravascular infusion<br />

1000 j.m. American National Red Cross 30/09/04<br />

250 j.m. American National Red Cross 30/09/04<br />

500 j.m. American National Red Cross 30/09/04<br />

8557 Monazole 7 Miconazolum Vaginal cream 2 % Technilab Inc. 31/12/08<br />

8558 Mondolar 100 Premiks Monenzyna sodowa Premix for veterinary<br />

use<br />

8559 Mondolar 200 Premiks Monenzyna sodowa Premix for veterinary<br />

use<br />

8560 Mono Mack Depot Isosorbidi mononitras Prolonged release<br />

tablets<br />

KRKA d.d. 24/05/07<br />

KRKA d.d. 24/05/07<br />

100 mg Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

8561 Monobenzone Monobenzonum Ointment 200 mg/g VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

8562 Monocard 10 Isosorbidi mononitras Capsules 10 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

8563 Monocard 20 Isosorbidi mononitras Capsules 20 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

20/05/06<br />

31/12/05<br />

10/05/06<br />

10/05/06<br />

8564 Mononit 10 Isosorbidi mononitras Film-coated tablets 10 mg Sanofi-Synthelabo Sp. z o.o. 30/09/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1121<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8565 MONONIT 100 Retard Isosorbidi mononitras Film-coated,<br />

prolonged release<br />

tablets<br />

100 mg Sanofi — Synthelabo Sp.<br />

z o.o.<br />

31/12/08<br />

8566 Mononit 20 Isosorbidi mononitras Film-coated tablets 20 mg Sanofi-Synthelabo Sp. z o.o. 30/09/05<br />

8567 Mononit 40 Isosorbidi mononitras Film-coated tablets 40 mg Sanofi-Synthelabo Sp. z o.o. 30/09/05<br />

8569 MONONIT 60 Retard Isosorbidi mononitras Film-coated,<br />

prolonged release<br />

tablets<br />

8568 Mononit 60 retard Isosorbidi mononitras Prolonged release<br />

tablets<br />

8571 MONONIT 80 Retard Isosorbidi mononitras Film-coated,<br />

prolonged release<br />

tablets<br />

8570 Mononit 80 Retard Isosorbidi mononitras Prolonged release<br />

tablets<br />

8572 Mononit100 Retard Isosorbidi mononitras Prolonged release<br />

tablets<br />

60 mg Sanofi — Synthelabo Sp.<br />

z o.o.<br />

31/12/08<br />

60 mg Sanofi-Synthelabo Sp. z o.o. 23/07/06<br />

80 mg Sanofi — Synthelabo Sp.<br />

z o.o.<br />

31/12/08<br />

80 mg Sanofi-Synthelabo Sp. z o.o. 24/05/06<br />

100 mg Sanofi-Synthelabo Sp. z o.o. 24/05/06<br />

8573 Monopril Fosinoprilum Tablets 10 mg Bristol-Myers Squibb S.p.A. 31/12/08<br />

8574 Monopril Fosinoprilum Tablets 20 mg Bristol-Myers Squibb S.p.A. 31/12/08<br />

8575 Monotard HM Insulini cum Zinco<br />

suspensio<br />

8576 Monotard HM Insulini cum Zinco<br />

suspensio<br />

8577 Monotard MC Insulini cum Zinco<br />

suspensio<br />

8578 MONOTARD MC 100 J.M./Ml Insulinum cum Zinco<br />

suspensio<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

8579 Monovitan C 500 Prolongatum Acidum ascorbicum Prolonged release<br />

tablets<br />

100 j.m./ml Novo Nordisk A/S 31/07/04<br />

40 j.m./ml Novo Nordisk A/S 31/07/04<br />

40 j.m./ml Novo Nordisk A/S 31/07/04<br />

100 j.m./ml Novo Nordisk A/S 31/12/08<br />

500 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

8580 Monovitan C Acidum ascorbicum Tablets 500 mg Krakowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8581 Monovitan C Acidum ascorbicum<br />

(vit C)<br />

8582 Monovitan C Acidum ascorbicum<br />

(vit C)<br />

8583 Monovitan C Acidum ascorbicum<br />

(vit C)<br />

8584 Monovitan C Acidum ascorbicum<br />

(vit C)<br />

8585 Monovitan C Cynk Calcii lactas gluconas +<br />

Acidum ascorbicum +<br />

Zincum<br />

Coated tablets 100 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Coated tablets 200 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Oral drops, solution 100 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Tablets 50 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Effervescent tablets preparat<br />

złoz˙ony<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

8586 MONOVITAN C Forte Acidum ascorbicum Effervescent tablets 1000 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

8587 MONOVITAN C Forte O<br />

Smaku Cytrynowym Bez<br />

Dodatku Cukru<br />

Acidum ascorbicum Effervescent tablets 1000 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/05<br />

31/12/05<br />

23/11/05<br />

15/03/06<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

1122 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8588 MONOVITAN C Forte O<br />

Smaku Pomarańczowym Bez<br />

Dodatku Cukru<br />

8589 Monovitan C Plus Calcii lactas gluconas +<br />

Acidum ascorbicum +<br />

Calcii carbonas<br />

8590 MONOVITANC O Smaku<br />

Pomarańczowy<br />

8591 Monozide Fosinoprilum +<br />

Hydrochlorothiazidum<br />

8592 Monozide Fosinoprilum +<br />

Hydrochlorothiazidum<br />

Acidum ascorbicum Effervescent tablets 1000 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Effervescent tablets 260mg +<br />

500 mg<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Acidum ascorbicum Effervescent tablets 500 mg Krakowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tablets 10 mg +<br />

12,5 mg<br />

Tablets 20 mg +<br />

12,5 mg<br />

8593 Monteban 100 Premix Narazyna Premix for veterinary<br />

use<br />

8594 Monural Fosfomycinum +<br />

Trometamolum<br />

8595 Monural Fosfomycinum +<br />

Trometamolum<br />

Granules for oral<br />

solution<br />

Granules for oral<br />

solution<br />

8596 Morbital Pentobarbital Solution for veterinary<br />

use<br />

Bristol — Myers Squibb<br />

S.p.A.<br />

Bristol — Myers Squibb<br />

S.p.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Elanco Animal Health 18/03/04<br />

Zambon Group S.p.A. 31/03/07<br />

Zambon Group S.p.A. 31/03/07<br />

Biowet Puławy 10/02/04<br />

8597 Morfiny chlorowodorek Pharma Cosmetic, Kraków 31/12/05<br />

8598 Morfiny chlorowodorek Polfa Kutno 31/12/05<br />

8599 Morphina Hydrochlorid Morphinum Solution for injection 10 mg/ml Zdrowie Narodu 31/12/08<br />

8600 Morphini sulfas Morphinum Solution for injection 10 mg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8601 Morphini sulfas Morphinum Solution for injection 20 mg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8602 Morphini Sulfas 0,1 % Spinal Morphinum Solution for injection 1 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

8603 Moss 100 Morphinum Suppository 100 mg Cenes 31/12/08<br />

8604 Moss 35 Morphinum Suppository 35 mg Cenes 31/12/08<br />

8605 Moss 50 Morphinum Suppository 50 mg Cenes 31/12/08<br />

8606 Moss 75 Morphinum Suppository 75 mg Cenes 31/12/08<br />

8607 Motilium Domperidonum Film-coated tablets 10 mg Janssen Pharmaceutica N.V. 31/07/05<br />

8608 Motilium Lingual Domperidonum Oromucosal soluble<br />

tablets<br />

10 mg Janssen Pharmaceutica N.V. 31/07/05<br />

8609 Mova Nitrat Pipette Argenti nitras Eye drops, solution 10 mg/ml Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8610 Movalis Meldesikamum Solution for injection 15 mg/1,5 ml Boehringer Ingelheim<br />

International GmbH<br />

8611 Movalis Meloxicamum Suppository 15 mg Boehringer Ingelheim<br />

International GmbH<br />

8612 Movalis Meloxicamum Suppository 7.5 mg Boehringer Ingelheim<br />

International GmbH<br />

8613 Movalis Meloxicamum Tablets 15 mg Boehringer Ingelheim<br />

International GmbH<br />

25/05/05<br />

31/12/08<br />

31/01/05<br />

31/01/05<br />

31/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1123<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8614 Movalis Meloxicamum Tablets 7.5 mg Boehringer Ingelheim<br />

International GmbH<br />

31/12/07<br />

8615 Movicol Propyleno glycolum Powder Norgine Pharma 31/12/08<br />

8616 Moxenil Nimesulidum Tablets 100 mg Adamed Sp. z o.o. 31/12/08<br />

8617 MST Continus Morphinum Film-coated, modified<br />

release tablets<br />

8618 MST Continus Morphinum Film-coated, modified<br />

release tablets<br />

8619 MST Continus Morphinum Film-coated, modified<br />

release tablets<br />

8620 MST Continus Morphinum Film-coated, modified<br />

release tablets<br />

8621 MST Continus Morphinum Film-coated, modified<br />

release tablets<br />

10 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

100 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

200 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

60 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/05<br />

31/01/05<br />

31/01/05<br />

31/01/05<br />

31/01/05<br />

8622 Mucedokehl D5 iniekcje Sanum-Kehlbeck 31/12/05<br />

8623 Mucedokehl D5 krople Sanum-Kehlbeck 31/12/05<br />

8624 Mucilagosan Herba Oskar 31/12/08<br />

8625 Mucispol Inter Aspol, Warszawa 31/12/08<br />

8626 Mucivital Lab. Arkopharma 31/12/08<br />

8627 Mucoangin® Ambroxolum Buccal tablets 20 mg Boehringer Ingelheim<br />

International GmbH<br />

8628 Mucobovin Inaktywowana<br />

szczepionka dla bydła<br />

przeciwko wirusowej<br />

biegunce i chorobie<br />

błon s´luzowych<br />

wywołanej przez<br />

pestiwirusy<br />

8629 Mucofalk A Plantaginis ovatae testa Granules for oral<br />

solution<br />

8630 Mucofalk O Plantaginis ovatae testa Granules for oral<br />

solution<br />

Suspension for veterinary<br />

use<br />

31/12/08<br />

Merial SAS 18/09/07<br />

3.25 g/5 g Dr Falk Pharma GmbH 24/08/05<br />

3.25 g/5 g Dr Falk Pharma GmbH 24/08/05<br />

8631 Mucofluid Mesnum Nasal spray, solution 50 mg/ml UCB S.A. Pharma Sector 30/06/04<br />

8632 Mucokehl D3 Sanum-Kehlbeck 31/12/05<br />

8633 Mucokehl D5 Sanum-Kehlbeck 4/08/07<br />

8634 Mucokehl D5 Sanum-Kehlbeck 4/08/07<br />

8635 Mucokehl D5 Amp. Sanum-Kehlbeck 31/12/05<br />

8636 Mucopront Carbocisteinum Capsules 375 mg Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

8637 Mucopront Carbocisteinum Syrup 250 mg/5 g Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

31/07/04<br />

31/12/04<br />

8638 Mucosa compositum Amp. Heel GmbH 31/12/07


EN<br />

1124 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8639 Mucosiffa Szczepionka dla bydła<br />

przeciwko wirusowej<br />

biegunce bydła I<br />

zapaleniu błon<br />

s´luzowych<br />

Lyophilisate for veterinary<br />

use<br />

Merial 31/12/08<br />

8641 Mucosit Preparat ziołowy Gingival gel Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

8640 Mucosit Preparat ziołowy Mouth wash solution Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

8643 Mucosolvan Ambroxolum Concantrate for<br />

solution for<br />

intravenous infusion<br />

1 g/50 ml Boehringer Ingelheim<br />

International GmbH<br />

8642 Mucosolvan Ambroxolum Granules 15 mg/3g Boehringer Ingelheim<br />

International GmbH<br />

8644 Mucosolvan Ambroxolum Nebuliser solution 7.5 mg/ml Boehringer Ingelheim<br />

International GmbH<br />

8645 Mucosolvan Ambroxolum Solution for injection 7.5 mg/ml Boehringer Ingelheim<br />

International GmbH<br />

8646 Mucosolvan Ambroxolum Syrup 15 mg/15 ml Boehringer Ingelheim<br />

International GmbH<br />

8647 Mucosolvan Ambroxolum Syrup 30 mg/5 ml Boehringer Ingelheim<br />

International GmbH<br />

8648 Mucosolvan Ambroxolum Tablets 30 mg Boehringer Ingelheim<br />

International GmbH<br />

8649 Mucotussin® Dextometorphanum Syrup 5 mg/5 ml Boehringer Ingelheim<br />

International GmbH<br />

8650 Mucotussin® Dextometorphanum Syrup 10 mg/5 ml Boehringer Ingelheim<br />

International GmbH<br />

8651 Mukobron Ambroxolum Syrup 15 mg/5ml Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

8652 Mukobron Ambroxolum Syrup 30 mg/5 ml Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

8653 Mukobron Ambroxolum Tablets 30 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

8654 Mukolina Carbocisteinum Syrup 20 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

8655 Mukolina Carbocisteinum Syrup 50 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

8656 Multavit Junior Powder for oral<br />

solution<br />

8657 Multavit Junior Powder for oral<br />

solution<br />

8658 Multavit Junior Powder for oral<br />

solution<br />

8659 Multavit Junior Powder for oral<br />

solution<br />

8660 Multavit Junior Powder for oral<br />

solution<br />

8661 Multavit o smaku<br />

pomarańczowym<br />

Multivitamins and trace<br />

elements<br />

30/10/05<br />

10/05/06<br />

31/05/04<br />

22/02/06<br />

31/05/04<br />

31/05/04<br />

31/12/08<br />

31/05/04<br />

31/05/04<br />

31/12/08<br />

31/12/08<br />

22/11/05<br />

30/06/07<br />

22/11/05<br />

30/10/05<br />

30/10/05<br />

Polfarmex S.A 28/02/06<br />

Polfarmex S.A 28/02/06<br />

Polfarmex S.A 28/02/06<br />

Polfarmex S.A 28/02/06<br />

Polfarmex S.A 28/02/06<br />

Effervescent powder Polfarmex S.A 30/09/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1125<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8662 MULTI — B Strong Preparat złoz˙ony Tablets Vitabalans Oy 31/12/08<br />

8663 Multibionta Plus Mineral Multivitamins and trace<br />

elements<br />

8664 Multibiotic Bacitracinum +<br />

Neomycinum +<br />

Polymyxinum B<br />

8665 Multiektifo Amitrazum,<br />

bromfenwinfos<br />

Film-coated tablets Merck KGaA 31/07/04<br />

Ointment (10mg + 5mg<br />

+ 0,833mg)/g<br />

Liquid for veterinary<br />

use<br />

8666 MultiHance Dimeglumini gadobenas Solution for<br />

intravenous injection<br />

Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

27/09/06<br />

Biowet Puławy 31/12/08<br />

529 mg/ml Bracco S.p.A. 25/10/06<br />

8667 Multiminka Beta Preparat złoz˙ony Capsules Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8668 Multiminka M Capsules Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8669 Multisal Film-coated tablets Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8670 Multi-Sanostol Preparat złoz˙ony Syrup Altana Consumer Health<br />

GmbH<br />

31/12/08<br />

31/12/08<br />

30/10/05<br />

30/04/04<br />

8671 Multi-tabs Acidum ascorbicum Buccal tablet Ferrosan A/S 31/12/08<br />

8672 Multi-tabs Multivitamins Drops Ferrosan A/S 31/12/08<br />

8673 Multi-tabs Multivitamins and trace<br />

elements<br />

8674 Multi-tabs Multivitamins and trace<br />

elements<br />

8675 Multi-tabs Multivitamins and trace<br />

elements<br />

8676 Multi-tabs Classic Multivitamins and trace<br />

elements<br />

8677 Multi-tabs z beta-karotenem Multivitamins and trace<br />

elements<br />

8678 Multivitamin Injection Roztwór<br />

wielowitaminowy<br />

Buccal tablet Ferrosan A/S 31/12/08<br />

Buccal tablets for<br />

chldren (1-6 years<br />

old)<br />

Ferrosan A/S 31/07/04<br />

Film-coated tablets Ferrosan A/S 31/07/04<br />

Film-coated tablets Ferrosan A/S 14/03/07<br />

Film-coated tablets Ferrosan A/S 31/12/08<br />

Solution for veterinary<br />

use<br />

Norbrook 31/12/08<br />

8679 Multivitaminum Preparat witaminowy Coated tablets Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8680 Multivitaminum Film-coated tablets Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8681 Multivitaminum forte Preparat witaminowy Coated tablets Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/11/05<br />

31/12/05<br />

30/11/05<br />

8682 Multivitamol Syrup N.P. Pharma Sp. z o.o. 31/12/08<br />

8683 Mumpsvax Vaccinum parotitidis<br />

vivum<br />

Lyophilisate and<br />

solvent for solution<br />

for subcutaneous<br />

injection<br />

0.5 ml Merck Sharp & Dohme Idea<br />

Inc.<br />

8684 Mupirocin Muporicinum Ointment 20 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

8685 Mupirocin-B Muporicinum +<br />

Betamethasonum<br />

Ointment 20 mg, 0,5 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/04<br />

31/12/08<br />

31/12/08


EN<br />

1126 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8686 Mupirox Mupirocinum Ointment 20 mg/g Blau Farma Sp. z o.o. Spółka<br />

Komandytowa<br />

8687 Murine Tears Alcohol polyvinylicus +<br />

Povidonum<br />

8688 Murine Tears Plus Alcohol polyvinylicus +<br />

Tetryzolinum +<br />

Povidonum<br />

8689 Muscolan Methylis salicylas +<br />

Mentholum<br />

Eye drops, solution Ross Products Division-<br />

Abbott Laboratories<br />

Eye drops, solution Ross Products Division-<br />

Abbott Laboratories<br />

Ointment preparat<br />

złoz˙ony<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

8690 Muscoril Thiocolchicosidum Capsules 4 mg Sanofi — Synthelabo Sp.<br />

z o.o.<br />

8691 Muscoril Thiocolchicosidum Solution for<br />

intramuscular<br />

injection<br />

4 mg/2ml Sanofi — Synthelabo Sp.<br />

z o.o.<br />

9/08/06<br />

4/07/07<br />

4/07/07<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

8692 Musculavit Preparat ziołowy Capsules, soft Bional International BV 24/08/05<br />

8693 MUSE 1000 Ug Alprostadilum Vivus 31/12/08<br />

8694 MUSE 125 Ug Alprostadilum Vivus 31/12/08<br />

8695 MUSE 250 Ug Alprostadilum Vivus 31/12/08<br />

8696 MUSE 500 Ug Alprostadilum Vivus 31/12/08<br />

8697 MUSSOVIT B + C + E O<br />

Smaku Pomarańczowym<br />

Preparat złoz˙ony Effervescent tablets Krakowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

8698 Mustophoran Fotemustinum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

31/12/08<br />

208 mg Les Laboratoires Servier 30/04/05<br />

8700 Myclopir Ciclopiroxum Coutanous liquid 1 % (10 mg/g) Zakłady Farmaceutyczno —<br />

Aerozolowe ‘UNIA’<br />

Spółdzielnia Pracy<br />

8699 Myclopir Ciclopiroxum Lacquer 8 % (80 mg/g) Zakłady Farmaceutyczno —<br />

Aerozolowe ‘UNIA’<br />

Spółdzielnia Pracy<br />

8701 Mycobifen Bifanazolum Cream 1 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

8702 Mycomax Fluconazolum Solution for<br />

intravenous infusion<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

2 mg/ml Leciva Inc. 30/09/07<br />

8703 Mycomax 100 Fluconazolum Capsules 100 mg Leciva Inc. 30/09/07<br />

8704 Mycomax 150 Fluconazolum Capsules 150 mg Leciva Inc. 30/09/07<br />

8705 Mycomax 200 Fluconazolum Capsules 200 mg Leciva Inc. 30/09/07<br />

8706 Mycomax 50 Fluconazolum Capsules 50 mg Leciva Inc. 30/09/07<br />

8707 Mycophyt Natamycyna Powder for veterinary<br />

use<br />

8708 Mycosalmovir Szczepionka dla gołe˛bi<br />

przeciw salmonelozie,<br />

paramyksowirozie,<br />

mykoplazmozie<br />

8709 Mycosolon Mazipredonum +<br />

Miconazoli nitras<br />

Emulsion for veterinary<br />

use<br />

Ointment (2,5mg +<br />

20mg)/g<br />

Intervet 4/05/04<br />

Biowet Puławy 7/02/05<br />

Gedeon Richter Ltd. 30/06/04<br />

8710 Mycospor Bifonazolum Cream 10 mg/g Bayer AG 11/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1127<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8711 Mycospor Bifonazolum Shampoo 1 % Bayer Quimica Farmaceutica<br />

S.A.<br />

8712 Mycospor Onychoset Bifonazolum +<br />

Carbamidum<br />

31/12/08<br />

Ointment Bayer AG 11/10/05<br />

8713 Mycosyst Fluconazolum Capsules 50 mg Chemical Works of Gedeon<br />

Richter Ltd.<br />

8714 Mycosyst Fluconazolum Capsules 100 mg Chemical Works of Gedeon<br />

Richter Ltd.<br />

8715 Mycosyst Fluconazolum Capsules 150 mg Chemical Works of Gedeon<br />

Richter Ltd.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

8716 Mycosyst Fluconazolum Capsules 200 mg Gedeon Richter Ltd. 31/12/08<br />

8717 Mycosyst Fluconazolum Solution for<br />

intravenous infusion<br />

8718 Myc-Vac Inaktywowana<br />

szczepionka dla kur<br />

przeciw zakaz˙eniom<br />

Mycoplasma<br />

gallisepticum<br />

Emulsion for veterinary<br />

use<br />

2 mg/ml Chemical Works of Gedeon<br />

Richter Ltd.<br />

31/12/08<br />

FATRO S.p.A. 19/02/06<br />

8719 Mydło lecznicze Pharma Zentrale 9/01/05<br />

8720 Mydło potasowe Pharma Cosmetic, Kraków 31/12/08<br />

8721 Mydło potasowe Pharma Zentrale 31/12/08<br />

8722 Mydło potasowe Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

8723 Mydocalm Lidocainum +<br />

Tolperisonum<br />

Solution for injection (2,5mg +<br />

100mg)/ml<br />

31/12/08<br />

Gedeon Richter Ltd. 31/05/04<br />

8724 Mydocalm Tolperisonum Film-coated tablets 50 mg Gedeon Richter Ltd. 31/05/04<br />

8725 Mydocalm forte Tolperisonum Film-coated tablets 150 mg Gedeon Richter Ltd. 31/05/04<br />

8726 Mydriacyl Tropicamidum Eye drops 10 mg/ml Alcon Couvreur N.V. 30/06/04<br />

8727 Mydriacyl 0,5 % Tropicamidum Eye drops 5 mg/ml Alcon Couvreur N.V. 30/06/04<br />

8728 Myelovax Szczepionka<br />

przeciwko zakaz´nemu<br />

zapaleniu mózgu i<br />

rdzenia kre˛gowego dla<br />

kur<br />

Lyophilisate for veterinary<br />

use<br />

Merial 14/06/04<br />

8730 Mykodermina Coutanous liquid 60 mg/g Pampa — Laboratorium<br />

Farmaceutyczno-Kosmetyczne<br />

8731 Mykodermina Medicated powder Pampa — Laboratorium<br />

Farmaceutyczno-Kosmetyczne<br />

8729 Mykodermina Ointment 60 mg/g Pampa — Laboratorium<br />

Farmaceutyczno-Kosmetyczne<br />

8732 Mykofar Forte Medicated powder Zakład Produkcyjno-<br />

Usługowy FARKO<br />

8733 Mykofar Mite Medicated powder Zakład Produkcyjno-<br />

Usługowy FARKO<br />

8734 Myleran Busulfanum Film-coated tablets 2 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

27/09/05<br />

27/09/05<br />

30/06/04<br />

8735 Myolastan Tetrazepamum Film-coated tablets 50 mg Sanofi-Winthrop 26/10/05


EN<br />

1128 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8736 Myolaxin 15 % Griseofulvinum Solution for veterinary<br />

use<br />

Vetoquinol S.A. 15/01/06<br />

8737 Myomax Tetrazepamum Film-coated tablets 50 mg Sanofi-Synthelabo Sp. z o.o. 31/12/05<br />

8738 Myopam 100 Tetrazepamum Tablets 100 mg CHEPHASAAR GmbH 31/12/08<br />

8739 Myopam 25 Tetrazepamum Tablets 25 mg CHEPHASAAR GmbH 31/12/08<br />

8740 Myopam 50 Tetrazepamum Tablets 50 mg CHEPHASAAR GmbH 31/12/08<br />

8741 Myovan Tetrazepamum Tablets 50 mg Dr Kade Pharmaceutical<br />

Fabrik<br />

31/12/08<br />

8742 Myristica sebifera comp. Amp. WALA-Heilmittel GmbH 31/08/05<br />

8743 Myristica sebifera comp. Granules WALA-Heilmittel GmbH 31/08/05<br />

8744 Mytelase Ambenonii chloridum Tablets 10 mg Sanofi-Synthelabo France 30/04/04<br />

8745 Myxovac Szczepionka przeciw<br />

myksomatozie<br />

królików<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Biowet Puławy 31/12/08<br />

8746 Nabumeton Nabumetonum Film-coated tablets 500 mg Zakłady Farmaceutyczno —<br />

Aerozolowe ‘UNIA’<br />

Spółdzielnia Pracy<br />

31/12/08<br />

8747 Nabumetone Nabumetonum Film-coated tablets 500 mg Aflofarm 31/12/08<br />

8748 Nabuton Nabumetonum Tablets 500mg ICN Polfa Rzeszów S.A. 26/09/07<br />

8749 Naclof Diclofenacum Eye drops 1 mg/ml Novartis Ophthalmics AG<br />

Hettlingen<br />

30/06/04<br />

8750 Nadmanganian potasu Cefarm Gdańsk 12/10/05<br />

8751 Nadmanganian potasu Galena, Wrocław 12/10/05<br />

8752 Nadmanganian potasu PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

8753 Nafpenzal DC Benzylopenicylina<br />

prokainowa, Sól<br />

sodowa nafcyliny,<br />

Siarczan<br />

dihydrostreptomycyny<br />

8754 Nafpenzal DC Benzylopenicylina<br />

prokainowa, Sól<br />

sodowa nafcyliny,<br />

Siarczan<br />

dihydrostreptomycyny<br />

8755 Nafpenzal MC Sól sodowa<br />

benzylopenicyliny, Sól<br />

sodowa nafcyliny,<br />

Siarczan<br />

dihydrostreptomycyny<br />

8756 Nafpenzal MC Sól sodowa<br />

benzylopenicyliny, Sól<br />

sodowa nafcyliny,<br />

Siarczan<br />

dihydrostreptomycyny<br />

Intramammary<br />

ointment<br />

Intramammary<br />

ointment<br />

Intramammary<br />

ointment<br />

Intramammary<br />

ointment<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

12/10/05<br />

Intervet International 4/05/04<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

28/04/04<br />

17/08/04<br />

Intervet 4/05/04<br />

8757 Naienie kozieradki Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

8760 Naklofen Diclofenacum Gastro-resistant<br />

tablets<br />

18/12/05<br />

50 mg Krka d.d., Novo mesto 31/07/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1129<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8761 Naklofen Diclofenacum Gastro-resistant<br />

tablets<br />

50 mg KRKA Polska Sp. z o.o. 31/01/06<br />

8763 Naklofen Diclofenacum Gel 10 mg/ml Krka d.d., Novo mesto 30/06/04<br />

8762 Naklofen Diclofenacum Prolonged release<br />

tablets<br />

100 mg Krka d.d., Novo mesto 31/07/04<br />

8759 Naklofen Diclofenacum Solution for injection 25 mg/ml Krka d.d., Novo mesto 31/07/04<br />

8758 Naklofen Diclofenacum Suppository 50 mg Krka d.d., Novo mesto 31/07/04<br />

8765 Naklofen Duo Diclofenacum Capsules 75 mg KRKA Polska Sp. z o.o. 31/12/08<br />

8764 Naklofen Duo Diclofenacum Modified release<br />

capsules<br />

8766 Nakom Carbidopum +<br />

Levodopum<br />

8767 Nakom Mite Carbidopum +<br />

Levodopum<br />

Tablets 25mg +<br />

250mg<br />

Tablets 25 mg +<br />

100mg<br />

75 mg Krka d.d., Novo mesto 31/05/05<br />

Lek Pharmaceuticals d.d. 30/06/04<br />

Lek Pharmaceuticals d.d. 30/06/04<br />

8768 Nalcrom Acidum cromoglicicum Capsules 100 mg Rhône-Poulenc Rorer Fisons<br />

Ltd.<br />

8769 Nalergine Loratadinum Tablets 10 mg Bristol-Myers Squibb Products<br />

S.A.<br />

9/05/05<br />

29/03/06<br />

8770 Nalewka Benedyktyńska Preparat ziołowy Oral solution Herbapol Łódz´ S.A. 31/01/06<br />

8771 Nalewka bursztynowa Dobrynin, Łódz´ 31/01/06<br />

8772 Nalewka gorzka Amara tinctura Tincture Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

21/05/07<br />

8773 Nalewka gorzka Amara tinctura Herbapol Kraków 21/05/07<br />

8774 Nalewka gorzka Amara tinctura Zakład Farmaceutyczny<br />

Amara, Kraków<br />

21/05/07<br />

8775 Nalewka kozłkowa Tinctura valerianae Cefarm Gdańsk 31/12/05<br />

8776 Nalewka kozłkowa Tinctura valerianae Herbapol Kraków 31/12/05<br />

8777 Nalewka kozłkowa Tinctura valerianae Herbapol Lublin 31/12/05<br />

8778 Nalewka kozłkowa Tinctura valerianae Herbapol Wrocław 31/12/05<br />

8779 Nalewka kozłkowa Tinctura valerianae Lefarm, Bydgoszcz 31/12/05<br />

8780 Nalewka kozłkowa Tinctura valerianae Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

31/12/05<br />

8781 Nalewka kozłkowa Tinctura valerianae Pharma Cosmetic, Kraków 31/12/05<br />

8782 Nalewka kozłkowa Tinctura valerianae Pharma Zentrale 31/12/05<br />

8783 Nalewka kozłkowa Tinctura valerianae Phytopharm Kle˛ka S.A. 31/12/05<br />

8784 Nalewka kozłkowa Tinctura valerianae PPF GEMI, Karczew 31/12/05<br />

8785 Nalewka kozłkowa Tinctura valerianae Prac. Konf. Leków<br />

M.Napiórkowska, Warszawa<br />

8786 Nalewka kozłkowa Tinctura valerianae Rolnicza Sp-nia Prod.-<br />

Usługowa, Kraków<br />

31/12/05<br />

31/12/05


EN<br />

1130 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8787 Nalewka kozłkowa Tinctura valerianae Zakład Farmaceutyczny<br />

Amara, Kraków<br />

31/12/05<br />

8788 Nalewka kozłkowa na eterze Pharma Zentrale 19/02/05<br />

8789 Nalewka mie˛towa Tinctura menthae<br />

piperitae<br />

8790 Nalewka mie˛towa Tinctura menthae<br />

piperitae<br />

8791 Nalewka mie˛towa Tinctura menthae<br />

piperitae<br />

8792 Nalewka mie˛towa Tinctura menthae<br />

piperitae<br />

8793 Nalewka mie˛towa Tinctura menthae<br />

piperitae<br />

8794 Nalewka mie˛towa Tinctura menthae<br />

piperitae<br />

8795 Nalewka mie˛towa Tinctura menthae<br />

piperitae<br />

8796 Nalewka mie˛towa Tinctura menthae<br />

piperitae<br />

8797 Nalewka mie˛towa Tinctura menthae<br />

piperitae<br />

8798 Nalewka mie˛towa Tinctura menthae<br />

piperitae<br />

8799 Nalewka mie˛towa Tinctura menthae<br />

piperitae<br />

Cefarm Gdańsk 31/12/05<br />

Herbapol Kraków 31/12/05<br />

Lefarm, Bydgoszcz 31/12/05<br />

Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

31/12/05<br />

Pharma Cosmetic, Kraków 31/12/05<br />

Pharma Zentrale 31/12/05<br />

Phytopharm Kle˛ka S.A. 31/12/05<br />

PPF GEMI, Karczew 31/12/05<br />

Prac. Konf. Leków<br />

M.Napiórkowska, Warszawa<br />

Rolnicza Sp-nia Prod.-<br />

Usługowa, Kraków<br />

Zakład Farmaceutyczny<br />

Amara, Kraków<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

8800 Nalewka z de˛bianek Pharma Cosmetic, Kraków 31/12/08<br />

8801 Nalewka z de˛bianek Pharma Zentrale 31/12/08<br />

8802 Nalewka z de˛bianek Prac. Konf. Leków<br />

M.Napiórkowska, Warszawa<br />

8803 Nalewka z de˛bianek Zakład Farmaceutyczny<br />

Amara, Kraków<br />

31/12/08<br />

31/12/08<br />

8804 Nalewka z kła˛czy pie˛ciornika Herbapol Kraków 31/12/07<br />

8805 Nalewka z kła˛czy pie˛ciornika Pharma Cosmetic, Kraków 31/12/07<br />

8806 Nalewka z kła˛czy pie˛ciornika Pharma Zentrale 31/12/07<br />

8807 Nalewka z kła˛czy pie˛ciornika Prac. Konf. Leków<br />

M.Napiórkowska, Warszawa<br />

8808 Nalewka z kła˛czy pie˛ciornika Zakład Farmaceutyczny<br />

Amara, Kraków<br />

31/12/07<br />

31/12/07<br />

8809 Nalewka z kory chinowej Pharma Cosmetic, Kraków 31/12/08<br />

8810 Nalewka z kory chinowej Pharma Zentrale 31/12/08<br />

8811 Nalewka z korzenia goryczki Pharma Zentrale 14/02/05<br />

8812 Nalewka z korzenia<br />

ipekakuany<br />

Ipecacuanhae tinctura Pharma Cosmetic, Kraków 30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1131<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8813 Nalewka z korzenia<br />

ipekakuany<br />

8814 Nalewka z korzenia<br />

ipekakuany<br />

8815 Nalewka z korzenia<br />

ipekakuany<br />

Ipecacuanhae tinctura Pharma Zentrale 30/10/05<br />

Ipecacuanhae tinctura Prac. Konf. Leków<br />

M.Napiórkowska, Warszawa<br />

Ipecacuanhae tinctura Zakład Farmaceutyczny<br />

Amara, Kraków<br />

30/10/05<br />

30/10/05<br />

8816 Nalewka z koszyczka arniki Phytopharm Kle˛ka S.A. 9/03/06<br />

8817 Nalewka z kwiatostanu głogu Crataegi tinctura Tincture Pharma Cosmetic, Kraków 24/09/07<br />

8818 Nalewka z kwiatostanu głogu Crataegi tinctura Tincture Zakład Farmaceutyczny<br />

Amara, Kraków<br />

24/09/07<br />

8819 Nalewka z kwiatu arniki Herbapol Kraków 31/12/07<br />

8820 Nalewka z kwiatu arniki Pampa, Piaseczno 31/12/07<br />

8821 Nalewka z kwiatu arniki Pharma Cosmetic, Kraków 31/12/07<br />

8822 Nalewka z kwiatu arniki Pharma Zentrale 31/12/07<br />

8823 Nalewka z kwiatu arniki Zakład Farmaceutyczny<br />

Amara, Kraków<br />

31/12/07<br />

8824 Nalewka z lis´ci pokrzyku Belladonae tinctura Pharma Cosmetic, Kraków 31/12/08<br />

8825 Nalewka z lis´ci pokrzyku Belladonae tinctura Pharma Zentrale 31/12/08<br />

8826 Nalewka z lis´ci pokrzyku Belladonae tinctura Zakład Farmaceutyczny<br />

Amara, Kraków<br />

8827 Nalewka z owocni<br />

pomarańczy gorzkiej<br />

8828 Nalewka z owocni<br />

pomarańczy gorzkiej<br />

8829 Nalewka z owocni<br />

pomarańczy gorzkiej<br />

8830 Nalewka z owocni<br />

pomarańczy gorzkiej<br />

Aurantii amara<br />

tinctura<br />

Aurantii amara<br />

tinctura<br />

Aurantii amara<br />

tinctura<br />

Aurantii amara<br />

tinctura<br />

31/12/08<br />

Caesar & Loretz GmbH Caelo 31/12/08<br />

Herbapol Kraków 31/12/08<br />

Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

Zakład Farmaceutyczny<br />

Amara, Kraków<br />

31/12/08<br />

31/12/08<br />

8831 Nalewka z pieprzu tureckiego Pharma Cosmetic, Kraków 31/12/08<br />

8832 Nalewka z pieprzu tureckiego Pharma Zentrale 31/12/08<br />

8833 Nalewka z pieprzu tureckiego Prac. Konf. Leków<br />

M.Napiórkowska, Warszawa<br />

8834 Nalewka z pieprzu tureckiego Zakład Farmaceutyczny<br />

Amara, Kraków<br />

31/12/08<br />

31/12/08<br />

8835 Nalewka z ziela glistnika Chelidonii tinctura Pharma Cosmetic, Kraków 31/12/08<br />

8836 Nalewka z ziela glistnika Chelidonii tinctura Pharma Zentrale 31/12/08<br />

8837 Nalewka z ziela glistnika Chelidonii tinctura Prac. Konf. Leków<br />

M.Napiórkowska, Warszawa<br />

8838 Nalewka z ziela glistnika Chelidonii tinctura Zakład Farmaceutyczny<br />

Amara, Kraków<br />

8839 Nalewka z ziela konwalii<br />

mianowana<br />

31/12/08<br />

31/12/08<br />

Herbapol Wrocław 19/08/07


EN<br />

1132 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8840 Nalewka z ziela konwalii<br />

mianowana<br />

8841 Nalewka z ziela konwalii<br />

mianowana<br />

8842 Nalewka z ziela konwalii<br />

mianowana<br />

8843 Nalewka z ziela konwalii<br />

mianowana PHYTOCARD<br />

8844 Nalewka z ziela mi ka<br />

wiosennego<br />

8845 Nalewka z ziela mi ka<br />

wiosennego<br />

8846 Nalewka z ziela mi ka<br />

wiosennego<br />

8847 Nalewka z ziela miłka<br />

wiosennego<br />

Tinctura adonidis<br />

vernalis titrata<br />

Tinctura adonidis<br />

vernalis titrata<br />

Tinctura adonidis<br />

vernalis titrata<br />

Tinctura adonidis<br />

vernalis titrata<br />

Pharma Cosmetic, Kraków 19/08/07<br />

Pharma Zentrale 19/08/07<br />

Zakład Farmaceutyczny<br />

Amara, Kraków<br />

19/08/07<br />

Phytopharm Kle˛ka S.A. 31/12/07<br />

Herbapol Wrocław 6/01/06<br />

Pharma Cosmetic, Kraków 6/01/06<br />

Pharma Zentrale 6/01/06<br />

Zakład Farmaceutyczny<br />

Amara, Kraków<br />

8848 Nalewka z ziela piołunu Prac. Konf. Leków<br />

M.Napiórkowska, Warszawa<br />

19/07/07<br />

5/11/04<br />

8849 Nalgesin Naproxenum Film-coated tablets 275 mg Krka d.d., Novo mesto 29/03/06<br />

8850 Nalgesin forte Naproxenum Film-coated tablets 550 mg Krka d.d., Novo mesto 29/03/06<br />

8851 Naloxonum hydrochloricum Naloxonum Solution for injection 400 mcg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

8852 Naniprus Lyophilisate and<br />

solvent for solution<br />

for injection<br />

8853 Nanocoll Preparat<br />

radiofarmaceutyczny<br />

Radiopharmaceutical<br />

kit<br />

30/11/05<br />

30 mg Pharmachim-Holding AD 31/07/04<br />

Nycomed Amersham Sorin<br />

S.R.L<br />

8854 Naowocnia Fasoli Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

31/12/08<br />

30/10/05<br />

8855 Naowocnia Fasoli Herb Herbapol Lublin S.A. 30/10/05<br />

8856 Naprosyn Naproxenum Tablets 250 mg Krka d.d., Novo mesto 31/05/04<br />

8857 Naprosyn Naproxenum Tablets 250 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

8866 Naproxen Naproxenum Gastro-resistant<br />

tablets<br />

8867 Naproxen Naproxenum Gastro-resistant<br />

tablets<br />

8870 Naproxen Naproxenum Gastro-resistant<br />

tablets<br />

8871 Naproxen Naproxenum Gastro-resistant<br />

tablets<br />

250 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

500 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/05/04<br />

30/06/06<br />

30/06/06<br />

250 mg Polfarmex S.A. 27/09/06<br />

500 mg Polfarmex S.A. 27/09/06<br />

8873 Naproxen Naproxenum Gel 10 % Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

8874 Naproxen Naproxenum Gel 100 mg/g EMO Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych doc dr hab..<br />

Farm. Michał Oginski<br />

31/12/08<br />

27/09/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1133<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8875 Naproxen Naproxenum Gel 100 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8876 Naproxen Naproxenum Gel 100 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

8877 Naproxen Naproxenum Gel 12 mg/g EMO Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych doc dr hab.<br />

Farm. Michał Oginski<br />

8878 Naproxen Naproxenum Gel 12 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

27/09/06<br />

27/09/06<br />

27/09/06<br />

27/09/06<br />

8879 Naproxen Naproxenum Gel 30 mg/g (3 %) Sanofi-Synthelabo Sp. z o.o. 27/09/06<br />

8872 Naproxen Naproxenum Oral suspension 125 mg/5ml Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

8858 Naproxen Naproxenum Suppository 250 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

8859 Naproxen Naproxenum Suppository 500 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

8860 Naproxen Naproxenum Tablets 100 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

8861 Naproxen Naproxenum Tablets 200 mg AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

8862 Naproxen Naproxenum Tablets 250 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05<br />

27/09/06<br />

27/09/06<br />

31/12/05<br />

27/09/06<br />

31/12/05<br />

8863 Naproxen Naproxenum Tablets 250 mg Polfarmex S.A 27/09/06<br />

8864 Naproxen Naproxenum Tablets 500 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05<br />

8865 Naproxen Naproxenum Tablets 500 mg Polfarmex S.A 27/09/06<br />

8868 Naproxen Naproxenum Tablets 200 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

8869 Naproxen Naproxenum Tablets 125 mg;<br />

250 mg;<br />

500 mg<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

8880 Naproxen 250 Naproxenum Suppository 250 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

8881 Naproxen 500 Naproxenum Suppository 500 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

8882 Naproxen E.C. 250 Naproxenum Film-coated,<br />

gastro-resistant tablets<br />

8883 Naproxen E.C. 500 Naproxenum Film-coated,<br />

gastro-resistant tablets<br />

8884 Naproxen Sodium Naproxenum Film-coated tablet 220 mg;<br />

550 mg<br />

31/12/08<br />

27/09/06<br />

31/12/05<br />

31/12/05<br />

250 mg Generics (UK) Limited 31/12/08<br />

500 mg Generics (UK) Limited 31/12/08<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

8885 Naramig Naratriptanum Film-coated tablets 2,5 mg Glaxo Wellcome House,<br />

Glaxo Wellcome Group<br />

8886 Naranotox plus Homoopatisches<br />

Laboratorium A.Pfluger<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

8887 Narcotan Halothanum Inhalation solution 100 mg Lečiva a.s. 31/07/04


EN<br />

1134 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8888 Narkamon 5 % Ketaminum Solution for veterinary<br />

use<br />

SPOFA 7/05/04<br />

8889 Naropin Ropivacainum Solution for injection 10 mg/ml AstraZeneca AB 23/11/05<br />

8890 Naropin Ropivacainum Solution for injection 7.5 mg/ml AstraZeneca AB 23/11/05<br />

8891 Naropin Ropivacainum Solution for injection<br />

or infusion<br />

2 mg/ml AstraZeneca AB 23/11/05<br />

8892 Nasacort Triamcinolonum Nasal spray 55 mcg/dawke˛ Rhône-Poulenc Rorer Ltd. 31/12/08<br />

8893 Nasal spray Nasal spray, solution Kato LABS Sp. z o.o. 31/01/06<br />

8894 Nasengel-ratiopharm Xylometazolinum Gel 0.1 % ratiopharm GmbH 31/12/04<br />

8895 Nasienie gorczycy białej Sinapis albae semen Herb Bogucki, Kraków 31/12/08<br />

8896 Nasienie gorczycy białej Sinapis albae semen Herb Zakład Zielarski ‘KAWON-<br />

HURT’ S.C., Gostyń<br />

8897 Nasienie gorczycy czarnej Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

31/12/08<br />

18/12/05<br />

8898 Nasienie kozieradki Herbalux, Warszawa 19/03/07<br />

8899 Nasienie kozieradki Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

8900 Nasienie kozieradki Zioła lecznicze-Boguccy,<br />

Kraków<br />

8901 Nasienie lnu Lini semen Aflofarm Farmacja Polska,<br />

Pabianice<br />

19/03/07<br />

19/03/07<br />

31/12/08<br />

8902 Nasienie lnu Lini semen Elanda, Rozprza 31/12/08<br />

8903 Nasienie lnu Lini semen Herba Oskar, Wierzbówiec 31/12/08<br />

8904 Nasienie lnu Lini semen Herbalux, Warszawa 31/12/08<br />

8905 Nasienie lnu Lini semen Herbapol Wrocław 31/12/08<br />

8906 Nasienie lnu Lini semen Instytut Włókien<br />

Naturalnych, Poznań<br />

8907 Nasienie lnu Lini semen Laboratorium<br />

Farmaceutyczne Jarosław<br />

Szczepańczyk<br />

8908 Nasienie lnu Lini semen Laboratorium<br />

Farmaceutyczne Jarosław<br />

Szczepańczyk<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

8909 Nasienie lnu Lini semen Lefarm, Bydgoszcz 31/12/08<br />

8910 Nasienie lnu Lini semen Phytopharm Dobrzyca 31/12/08<br />

8911 Nasienie lnu Lini semen Zakład DARY NATURY,<br />

Grodzisk<br />

8912 Nasienie lnu Lini semen Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

8913 Nasienie lnu Lini semen Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

8914 Nasienie lnu Lini semen Zioła Lecznicze-Boguccy,<br />

Kraków<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

8915 Nasienie płesznika Semen psyli Herb Herbapol Kraków 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1135<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8916 Nasiona Babki płesznika -<br />

Semen Psyllii<br />

8917 Nasiona Babki płesznika -<br />

Semen Psyllii<br />

Herb Herbapol Lublin S.A. 31/12/07<br />

Herb Agropharm S.A. 31/12/07<br />

8918 Nasiona gorczycy czarnej Herbapol Białystok 13/05/06<br />

8919 Nasiona gorczycy czarnej Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

13/05/06<br />

8920 Nasiona kozieradki Herbapol Białystok 13/05/06<br />

8921 Nasiona kozieradki Herbapol Lublin 13/05/06<br />

8922 Nasiona kozieradki Herbapol Pruszków 13/05/06<br />

8923 Nasiona kozieradki 1 -nasiona<br />

sproszkowane<br />

Herbapol Kraków 31/08/05<br />

8924 Nasiona lnu Lini semen Herbapol Lublin 31/12/07<br />

8925 Nasiona lnu AGROPHARM, Tuszyn k/<br />

Łodzi<br />

31/12/07<br />

8926 Nasiona lnu Herbapol Pruszków 31/12/07<br />

8927 Nasiona lnu 1 Herbapol Kraków 31/08/05<br />

8928 Nasiona Plantago ovata Herb Herba Studio Ms´cisz i<br />

Wspólnicy Spółka Jawna<br />

8929 Nasivin 0,01 % Oxymetazolini<br />

hydrochloridum<br />

8930 Nasivin 0,025 % Oxymetazolini<br />

hydrochloridum<br />

8932 Nasivin 0,05 % Oxymetazolini<br />

hydrochloridum<br />

8931 Nasivin 0,05 % Oxymetazolini<br />

hydrochloridum<br />

8933 Nasivin sanft 0,025 % Oxymetazolini<br />

hydrochloridum<br />

8934 Nasivin sanft 0,05 % Oxymetazolini<br />

hydrochloridum<br />

8935 Nasivin soft 0,01 % Oxymetazolini<br />

hydrochloridum<br />

8936 Nasobec Beclometasonum Nasal spray, water<br />

suspension<br />

30/10/05<br />

Nasal drops, solution 0.1 mg/g Merck KGaA 30/04/04<br />

Nasal drops, solution 0.25 mg/g Merck KGaA 30/04/04<br />

Nasal drops, solution 0.5 mg/g Merck KGaA 30/04/04<br />

Nasal spray, solution 0.5 mg/g Merck KGaA 30/04/04<br />

Nasal spray, solution 0.25 mg/ml Merck KGaA 27/09/06<br />

Nasal spray, solution 0.5 mg/ml Merck KGaA 6/12/06<br />

Nasal drops, solution 0.1 mg/ml Merck KGaA 27/09/06<br />

50 mcg/dawke˛<br />

donosowa˛<br />

Norton Healthcare Ltd. 30/09/04<br />

8937 Naso-Heel SN Drops Heel GmbH 31/12/07<br />

8938 Nasonex Mometasonum Nasal spray, water<br />

solution<br />

0.05 % Schering-Plough Labo N.V. 31/12/08<br />

8939 Natack Nimesulidum Tablets 100 mg US Pharmacia Sp. z o.o. 31/12/08<br />

8940 Natacyn Natamycinum Eye drops, suspension 50 mg/ml Alcon Laboratoires Inc Texas 30/04/04<br />

8941 Natamycyna Natamycinum Vaginal tablets 25 mg Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

30/09/05<br />

8942 Nateglinid Nateglinidum Film-coated tablets 60 mg POLFA KUTNO S.A. 31/12/08


EN<br />

1136 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8943 Nateglinid Nateglinidum Film-coated tablets 120 mg POLFA KUTNO S.A. 31/12/08<br />

8944 Nateglinid Nateglinidum Film-coated tablets 180 mg POLFA KUTNO S.A. 31/12/08<br />

8945 Natrium bicarbonicum 8,4 % Natrii hydrocarbonas Solution for<br />

intravenous injection<br />

8946 Natrium Chloratum 0,9 Inj. Natrii chloridum Solution for irrigation 9 mg/ml; poj.:<br />

5000 ml<br />

8948 Natrium chloratum 0,9 % Natrii chloridum Solution for<br />

intravenous infusion<br />

84 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA<br />

Spółka Akcyjna<br />

9 mg/ml Fresenius Kabi Polska Sp.<br />

z o.o.<br />

31/01/06<br />

31/12/08<br />

31/01/06<br />

8947 Natrium chloratum 0,9 % Natrii chloridum Solution for irrigation 9 mg/ml Baxter Terpol Sp. z o.o. 17/01/07<br />

8949 Natrium Chloratum 0,9 % Natrii chloridum Solution for veterinary<br />

use<br />

8950 Natrium Chloratum 0,9 % Chlorek sodu Solution for veterinary<br />

use<br />

Lubelskie Zakłady<br />

Farmaceutyczne ‘Polfa’ Spółka<br />

Akcyjna<br />

19/12/06<br />

Fresenius Kabi Polska 31/12/08<br />

8951 Natrium Chloratum 0,9 % INJ. Natrii chloridum Solution for infusion 9 mg/ml Baxter S.p.A. 23/11/05<br />

8952 Natrium chloratum 0,9 % inj. Natrii chloridum Solution for<br />

intravenous infusion<br />

8953 Natrium chloratum 0,9 % inj. Natrii chloridum Solution for<br />

intravenous infusion<br />

8954 Natrium chloratum 0,9 %<br />

OFTARINOL do przemywania<br />

oczu<br />

8955 Natrium chloratum 5.85 % Natrii chloridum Concentrate for<br />

solution for infusion<br />

9 mg/ml Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/06<br />

9 mg/ml Baxter Terpol Sp. z o.o. 31/01/06<br />

Zakłady Farmaceutyczne<br />

Polpharma SA, Starogard<br />

Gdański<br />

58.5 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/12/06<br />

31/01/06<br />

8956 Natrium citricum 3.8 % Pliva Kraków 29/10/06<br />

8957 Natrium Fluoratum Natrii fluoratum Buccal tablets 0,25 mg; 1mg<br />

fluoru<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/08<br />

8959 Natrium fluoratum Natrii fluoridum Buccal tablet 452 mcg F ICN Polfa Rzeszów S.A. 30/01/05<br />

8958 Natrium fluoratum Natrii fluoridum Tablets 226 mcg F ICN Polfa Rzeszów S.A. 30/01/05<br />

8960 Natrium nitrosum Natrii nitris Solution for<br />

intravenous injection<br />

8961 Natrium Sulfuricum Natrii sulfuricum Powder for veterinary<br />

use<br />

20 mg/1 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/01/06<br />

Biofaktor 31/12/08<br />

8962 Natrium-Homaccord Amp. Heel GmbH 31/12/08<br />

8963 Natrium-Homaccord Drops Heel GmbH 31/12/08<br />

8964 Natrum carbonicum complexe<br />

nr 10<br />

8965 Naturalny Beta Karoten -<br />

Prowitamina A<br />

8966 Naturapia Valerianae officinalis +<br />

Melissa officinalis<br />

8967 Naturapia — menopauza Cimicifugae rhizomae<br />

extr. sicc.<br />

8968 Naturapia — prostata Serenoae fructus extr.<br />

sicc.<br />

Drops Lehning Laboratoires 4/01/07<br />

Betacarotenum Tablets 20 mg Vitamex AB 31/07/04<br />

Film-coated tablets praparat<br />

złoz˙ony<br />

US Pharmacia 31/12/08<br />

Film-coated tablet 40 mg US Pharmacia Sp. z o.o.,<br />

Wrocław<br />

Film-coated tablet 160 mg US Pharmacia Sp. z o.o.,<br />

Wrocław<br />

30/09/07<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1137<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8969 Naturapia Przezie˛bienie I<br />

Grypa<br />

Rad. Echinaceae +<br />

Witamina C + Cynk<br />

8970 Naturapia Wzrok Vaccini myrtillus +<br />

Zinc + Witamina A<br />

Film-coated tablets praparat<br />

złoz˙ony<br />

Film-coated tablets praparat<br />

złoz˙ony<br />

US Pharmacia 31/12/08<br />

US Pharmacia 31/12/08<br />

8971 Naturapia-Osteoporoza Zwia˛zki wapnia Film-coated tablets US Pharmacia Sp. z o.o. 21/03/07<br />

8972 Naturkaps czosnek Allii sativi maceratio<br />

oleosa<br />

Capsules 270 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

8973 Naturkaps Koenzym Q10 Ubidecarenonum Capsules, soft 30 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

8974 Naturkaps Tran 500 mg Oleum Jecoris Aselli Capsules, soft 500 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

8975 Naturkaps wiesiołek Oenotherae biennis<br />

oleum<br />

Capsules, soft 500 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/08<br />

9/08/06<br />

16/05/07<br />

31/12/08<br />

8976 Naudicelle Capsules, soft Bio Oil International Ltd. 5/07/06<br />

8977 Navelbine Vinorelbinum Capsules 20 mg Pierre Fabre Medicament 27/06/07<br />

8978 Navelbine Vinorelbinum Capsules 30 mg Pierre Fabre Medicament 27/06/07<br />

8979 Navelbine Vinorelbinum Capsules 40 mg Pierre Fabre Medicament 27/06/07<br />

8980 Navelbine Vinorelbinum Solution for injection 10 mg/ml Pierre Fabre Medicament 30/06/04<br />

8981 Navoban Tropisetronum Capsules 5 mg Novartis Pharma AG 31/07/04<br />

8982 Navoban Tropisetronum Solution for injection 1 mg/ml Novartis Pharma AG 31/07/04<br />

8983 Nebilet Nebivololum Tablets 5 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

8984 Nectiv Inaktywowana<br />

szczepionka dla kur i<br />

indyków przeciw<br />

rzekomemu pomorowi<br />

drobiu<br />

8985 Nefopam Nefopamum<br />

hydrochloridum<br />

8986 Nefopam 1 % Nefopamum<br />

hydrochloridum<br />

8987 Nefopam 2 % Nefopamum<br />

hydrochloridum<br />

Water — oil emulsion for veterinary<br />

use<br />

30/04/04<br />

ABIC Ltd. 22/11/06<br />

Film-coated tablets 30 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Solution for injection 10 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Solution for injection 20 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

8988 Nefrecil Phenazopyridinum Tablets 100 mg Labor Farmaceutyczno-<br />

Chemiczna Spółdzielnia Pracy<br />

8989 Nefrobonisan Herbal tea Bonimed Laboratorium<br />

Medycyny Naturalnej<br />

8990 Nefrobonisan Instant herbal tea Laboratorium Medycyny<br />

Naturalnej ‘BONIMED’,<br />

Z˙ywiec<br />

8991 Nefrobonisol Oral solution Bonimed Laboratorium<br />

Medycyny Naturalnej<br />

8992 Nefrofit fix Betulae folium +<br />

Orthosiphonis folium +<br />

Solidaginis herba<br />

17/01/07<br />

17/01/07<br />

17/01/07<br />

31/01/06<br />

5/07/05<br />

5/07/05<br />

5/03/06<br />

Herbal tea Herbapol — Białostok S.A. 31/12/08


EN<br />

1138 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

8993 Nefrol Preparat ziołowy Oral solution Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

8994 Nefrosept Oral solution Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

8995 NeisVac-C Meningococcus,<br />

tetravalent purified<br />

polysaccharides antigen<br />

(Vaccinum<br />

Meningococcale<br />

polysaccharidicum)<br />

Suspension for<br />

intramuscular<br />

injection<br />

8996 Neloren Lincomycinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

8997 Nemast DC Erythromycinum +<br />

Neomycinum<br />

8998 Nemovac Atenuowana<br />

szczepionka dla kur<br />

przeciw syndromowi<br />

wielkiej głowy<br />

8999 Nemutin Tiamuliny<br />

wodorofumaran<br />

1 dawka<br />

0,5 ml<br />

Suspension for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

30/10/05<br />

31/12/05<br />

Baxter Vaccine AG 29/08/07<br />

300 mg/ml Lek Pharmaceuticals d.d. 30/06/04<br />

Vet-Agro 31/12/08<br />

Merial 12/03/06<br />

S.P.Veterina S.A. 16/04/07<br />

9000 Neo — Bronchol Ambroxolum Lozenge Divapharma — Knufike 31/12/08<br />

9001 Neo Vet-Cillin L.A. Amoxicillunum Suspension for veterinary<br />

use<br />

9002 Neo-Aesculan Aesculinum + Acidum<br />

tannicum<br />

Rectal gel (40mg +<br />

45mg)/g<br />

Vetem 5/07/04<br />

Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

9003 Neo-Angin Buccal tablet Divapharma-Knufinke<br />

Arzneimittelwerk GmbH<br />

9004 Neo-Angin Buccal tablet Divapharma-Knufinke<br />

Arzneimittelwerk GmbH<br />

9005 Neo-Angin N Nebuliser solution Divapharma-Knufinke<br />

Arzneimittelwerk GmbH<br />

9006 Neoazarina Tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

9007 Neobiotyl 100 Tylozyny zasada,<br />

Tylozyny winian<br />

9008 Neobiotyl 200 Tylozyny winian,<br />

Tylozyny zasada<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego S.A.<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego S.A.<br />

9009 Neo-Capsiderm Preparat złoz˙ony Ointment Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

9010 Neocardina Oral drops, solution Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

9011 Neocolipor Szczepionka dla s´wiń<br />

przeciw<br />

kolibakteriozie prosia˛t<br />

9012 Neocones Benzocainum +<br />

Neomycinum<br />

Suspension for veterinary<br />

use<br />

Dental tablets 5mg +<br />

15400 j.m.<br />

30/10/05<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

31/01/06<br />

20/06/05<br />

20/06/05<br />

30/10/05<br />

30/10/05<br />

Merial 7/05/04<br />

Septodont 31/08/04<br />

9013 Neogilurytmal Prajmalinum Film-coated tablets 20 mg Solvay Pharmaceuticals<br />

GmbH<br />

31/07/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1139<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9014 Neoglandyna Boraginis officinalis<br />

oleum + Tocopherolum<br />

Gelatin capsules 370 mg Tymofarm —<br />

Przedsie˛biorstwo Rolno-<br />

Przetwórcze<br />

9015 Neolakcid Capsules 1 mld bakterii /<br />

kps<br />

9016 Neomast Neomycinum Suspension for veterinary<br />

use<br />

30/09/05<br />

K & K Medicplast 31/12/08<br />

Biowet Drwalew 31/12/08<br />

9017 Neomigran Dihydroergotaminum Nasal spray 4 mg/ml Novartis Pharma AG 31/05/04<br />

9018 Neomycinum Neomycinum Cutaneous spray 6.8 mg/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

9019 Neomycinum Neomycinum Eye ointment 0.5 % Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

9020 Neomycinum Neomycinum Tablets 250mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

9021 Neomycinum 70 % Neomycinum Powder for veterinary<br />

use<br />

9022 Neomycinum wet. Aerozol Neomycinum Suspension for veterinary<br />

use<br />

9023 Neomycyna Neomycinum Powder for veterinary<br />

use<br />

30/10/05<br />

31/12/08<br />

30/10/05<br />

Interbiowet 31/12/07<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

31/12/08<br />

Vetos-Farma 29/05/04<br />

9024 Neomycyny siarczan BUFA b.v. Pharmaceutical<br />

Products<br />

19/08/05<br />

9025 Neomycyny siarczan Farm-Impex s.j., Gliwice 19/08/05<br />

9026 Neomycyny siarczan Pharma Cosmetic, Kraków 19/08/05<br />

9027 Neomycyny siarczan Pharma Zentrale 19/08/05<br />

9028 Neomycyny siarczan Polfa, Tarchomin 19/08/05<br />

9029 Neomycyny siarczan PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

19/08/05<br />

9030 Neomycyny siarczan Scholz, Sowin 19/08/05<br />

9031 Neomyzen Neomycinum Ointment 5 mg / 1 g ZIAJA Ltd. Zakład<br />

Produkcyjny Gdańsk<br />

9032 Neonormacol Herbal granules Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

31/12/08<br />

30/10/05<br />

9033 Neonormosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

9034 Neonormovit Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

9035 Neo-Pancreatinum Amylasum + Lipasum +<br />

Proteasum<br />

Film-coated tablets 150 mg<br />

(Lipasum<br />

4000j.m.)<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/10/05<br />

30/11/05<br />

9036 Neopektosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

9037 Neopektosan fix Mieszanka ziołowa Instant herbal tea Herbapol Łódz´ S.A. 30/06/06<br />

9038 Neopen Benzylopenicylina<br />

prokainowa,<br />

neomycyny siarczan<br />

9039 Neopoldanen Pygeum africanum +<br />

Zea maydis<br />

Suspension for veterinary<br />

use<br />

Intervet International 31/12/08<br />

Capsules, hard 20mg + 40mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

29/06/05


EN<br />

1140 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9040 Neopropiowet Sodu propionian, Sodu<br />

salicylan, Magnezu<br />

siarczan, Z˙elazawy<br />

siarczan, Manganu<br />

siarczan, Kobaltu<br />

siarczan, Aerosil,<br />

Siarczan miedzi<br />

9041 Neopyrin Coffeinum +<br />

Paracetamolum<br />

9042 Neopyrin ASA Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Paracetamolum<br />

Powder for veterinary<br />

use<br />

9043 NeoRecormon 1000 Erythropoietinum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

9044 NeoRecormon 10000 Erythropoietinum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

9045 Neo-Recormon 10000 do<br />

wstrzykiwacza Reco-Pen<br />

9046 Neo-Recormon 100000<br />

wielodawkowy<br />

Erythropoietinum Lyophilisate and<br />

solvent for solution<br />

for subcutaneous<br />

injection<br />

Erythropoietinum Lyophilisate and<br />

solvent for solution<br />

for subcutaneous and<br />

intravascular injection<br />

9047 NeoRecormon 2000 Erythropoietinum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

9048 NeoRecormon 20000 Erythropoietinum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

9049 Neo-Recormon 20000 do<br />

wstrzykiwacza Reco-Pen<br />

Erythropoietinum Lyophilisate and<br />

solvent for solution<br />

for subcutaneous<br />

injection<br />

9050 NeoRecormon 3000 Erythropoietinum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

31/12/08<br />

Tablets P.P.H.U. Biofarm Sp. z o.o. 29/06/05<br />

Tablets P.P.H.U. Biofarm Sp. z o.o. 30/04/06<br />

1000 j.m./<br />

0,3 ml<br />

10000 j.m./<br />

0,6 ml<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

10000 j.m. Hoffmann La Roche Ltd.<br />

Bazylea<br />

10000 j.m. Hoffmann La Roche Ltd.<br />

Bazylea<br />

2000 j.m./<br />

0,3 ml<br />

20000 j.m./<br />

0,6 ml<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

20000 j.m. Hoffmann La Roche Ltd.<br />

Bazylea<br />

3000 j.m./<br />

0,3 ml<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

9051 NeoRecormon 4000 Epoetinum Solution for injection 4000 j,m. Hoffmann La Roche Ltd.<br />

Bazylea<br />

9052 NeoRecormon 500 Erythropoietinum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

9053 NeoRecormon 5000 Erythropoietinum Solution for<br />

subcutaneous and<br />

intravenous injection<br />

9054 Neo-Recormon 50000<br />

wielodawkowy<br />

Erythropoietinum Lyophilisate and<br />

solvent for solution<br />

for subcutaneous and<br />

intravascular injection<br />

500 j.m./0,3 ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

5000 j.m./<br />

0,3 ml<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

50000 j.m. Hoffmann La Roche Ltd.<br />

Bazylea<br />

9055 NeoRecormon 6000 Epoetinum Solution for injection 6000 j,m. Hoffmann La Roche Ltd.<br />

Bazylea<br />

9056 NeoRecormon 60000 Epoetinum Powder and solvent<br />

for solution for<br />

injection<br />

60000 j,m. Hoffmann La Roche Ltd.<br />

Bazylea<br />

31/10/04<br />

31/10/04<br />

30/11/04<br />

30/11/04<br />

31/10/04<br />

31/10/04<br />

30/11/04<br />

31/10/04<br />

25/01/06<br />

31/10/04<br />

31/10/04<br />

30/11/04<br />

25/01/06<br />

25/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1141<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9057 Neosol Neomycinum Solution for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

25/05/04<br />

9058 Neospasmina Syrup Herbapol Lublin S.A. 30/10/05<br />

9059 Neospasmol Drops Herbapol Lublin S.A. 30/09/07<br />

9060 NeoSpect — Zestaw do<br />

sporza˛dzania<br />

radiofarmaceutyku<br />

Powder for solution<br />

for intravascular<br />

injection<br />

47 mcg Nycomed Imaging AS 11/10/06<br />

9061 Neostygminy metylosiarczan Pliva Kraków 24/05/06<br />

9062 Neo-synephrine Phenylephrinum Eye drops 100 mg/ml Sanofi Winthrop<br />

Pharmaceutical Group<br />

9063 Neotarchocin Oxytetracyclinum +<br />

Neomycinum<br />

9064 Neotarchocin granulat 36 %/<br />

25 %<br />

Neomycinum +<br />

Oxytetracicllinum<br />

9065 Neotarchomiocin Benzathini<br />

benzaylpenicillinum +<br />

Benzylpenicillinum<br />

procainicum +<br />

Dihydrostreptomycinum<br />

Powder for veterinary<br />

use<br />

Granules for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne Polfa S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

9066 Neotigason Acitretinum Capsules 10 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

9067 Neotigason Acitretinum Capsules 25 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

9069 Neoton Phosphocreatinum Lyophilisate and<br />

solvent for solution<br />

for intramuscular<br />

injection<br />

9068 Neoton Phosphocreatinum Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

infusion<br />

9070 Neotopic Bacitracinum +<br />

Neomycinum +<br />

Polymyxinum B<br />

30/06/04<br />

18/08/04<br />

31/12/08<br />

31/12/08<br />

31/03/07<br />

31/03/07<br />

500 mg Alfa Wassermann S.p.A. 31/03/05<br />

1 g Alfa Wassermann S.p.A. 31/07/04<br />

Ointment Polmex Sp. z o.o. 31/08/05<br />

9071 Neo-Tormentil Ointment Laboratorium Galenowe<br />

Olsztyn Sp. zo.o.<br />

31/01/06<br />

9072 Neourosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 31/12/08<br />

9073 Neourosan fix Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 31/12/08<br />

9074 Nephrotect Roztwór aminokwasów Solution for<br />

intravenous infusion<br />

0.1 g/ml Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

9075 Nepro Preparat odz˙ywczy Liquid Ross Products Division-<br />

Abbott Laboratories<br />

9076 Nepro o smaku orzechowym Preparat odz˙ywczy Liquid Ross Products Division-<br />

Abbott Laboratories<br />

9077 Nepro o smaku wisniowym Preparat odz˙ywczy Liquid Ross Products Division-<br />

Abbott Laboratories<br />

9078 Neprox Naproxenum Gastro-resistant<br />

tablets<br />

31/08/04<br />

31/07/04<br />

30/04/05<br />

30/04/05<br />

200 mg Polfarmex S.A. 31/12/08<br />

9079 Nervendragees- ratiopharm Preparat ziołowy Coated tablets ratiopharm GmbH 30/04/04


EN<br />

1142 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9080 Nervinex-fix Mieszanka ziołowa Instant herbal tea Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

9081 Nervinkaps Valerianae radix<br />

extractum siccum<br />

Gelatin capsules, hard 110 mg Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

30/10/05<br />

31/12/08<br />

9082 Nervinol Herbal tea Eldex-Medical 2/10/06<br />

9083 Nervinol Instant herbal tea Eldex-Medical 2/10/06<br />

9084 Nervinol-fix Instant herbal tea P.P.H. ‘Eldex-Medical’, Wiry 31/12/08<br />

9085 Nervinolum Lenouri cardieceae herba<br />

extractum, Lupuli<br />

strobulus extr, Melissae<br />

folium extractum,<br />

Lavandulae flos<br />

extractum<br />

Oral solution Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

9086 Nervinum Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

9087 Nervinum — fix Instant herbal tea Herbapol Lublin S.A. 30/10/05<br />

9088 Nervobonisan Herbal tea Bonimed Laboratorium<br />

Medycyny Naturalnej<br />

9089 Nervobonisol Oral solution Bonimed Laboratorium<br />

Medycyny Naturalnej<br />

9090 Nervogem preparat złoz˙ony Tablets Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

9091 Nervogran Herbal granules Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

5/07/05<br />

5/03/06<br />

31/12/08<br />

30/10/05<br />

9092 Nervoheel N Sublingual tablets Heel GmbH 30/06/07<br />

9093 Nervomix Preparat złoz˙ony Capsules Agropharm S.A. 31/12/07<br />

9094 Nervosan Mieszanka ziołowa Granules Herbapol Łódz´ S.A. 31/12/07<br />

9095 Nervosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

9096 Nervosan fix Mieszanka ziołowa Instant herbal tea Herbapol Łódz´ S.A. 30/04/06<br />

9098 Nervosol preparat złoz˙ony Coated tablets Wrocławskie Zakłady<br />

Zielarskie HERBAPOL S.A.<br />

9097 Nervosol Liquid Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

9099 Nervostop Valerianae radix Film-coated tablets 150 mg Medana Pharma Terpol<br />

Group S.A.<br />

9100 Nerwonal Oral drops Pampa — Laboratorium<br />

Farmaceutyczno-Kosmetyczne<br />

9101 Nerwovit Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

9102 Nerwovit Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

31/12/08<br />

31/03/07<br />

14/12/05<br />

30/06/07<br />

31/12/08<br />

31/12/08<br />

9103 NESTLE MODULEN Ibm Preparat złoz˙ony Powder Nestle Nederland B.V. 31/12/08<br />

9104 Netromycine Netilmicinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

100 mg/ml Schering-Plough Labo N.V. 30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1143<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9105 Netromycine Netilmicinum Solution for<br />

intramuscular<br />

injection and<br />

intravenous infusion<br />

25 mg/ml Schering-Plough Labo N.V. 30/04/04<br />

9106 Neupogen Filgrastimum Solution for injection 30 mln j.m./ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

9107 Neupogen Filgrastimum Solution for injection 60 mln j.m./ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

9108 Neupogen Filgrastimum Solution for injection 96 mln j.m./ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

31/12/04<br />

23/03/05<br />

23/03/05<br />

9109 Neuralgo-Rheum-Injeel Amp. Heel GmbH 31/12/07<br />

9110 Neurex alfa — acidum lipoicum Solution for injection HEXAL AG 31/12/08<br />

9111 Neurex 200 alfa — acidum lipoicum Tablets 200 mg HEXAL AG 31/12/08<br />

9112 Neurex 600 alfa — acidum lipoicum Film-coated tablets 600 mg HEXAL AG 31/12/08<br />

9113 Neuroflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

31/05/05<br />

9114 Neuro-Injeel Amp. Heel GmbH 31/12/07<br />

9115 Neurol 0,25 Alprazolamum Tablets 0.25 mg Lečiva a.s. 30/04/04<br />

9116 Neurol 1,0 Alprazolamum Tablets 1 mg Lečiva a.s. 30/04/04<br />

9117 Neurolipon — Mip 300 Acidum lipoicum Capsules 300 mg CHEPHASAAR GmbH 31/12/08<br />

9118 Neurolipon — Mip 600 Acidum lipoicum Capsules 600 mg CHEPHASAAR GmbH 31/12/08<br />

9119 NEUROMAX Forte Thiamini<br />

hydrochloridum,<br />

Pyridoxini<br />

hydrochloridum,<br />

Cyanocobalaminum<br />

Tablets (100 mg +<br />

200 mg +<br />

0.2 mg)<br />

Vitabalans Oy 31/12/08<br />

9120 Neurontin 100 Gabapentinum Capsules 100 mg Parke Davis GmbH 31/12/08<br />

9121 Neurontin 300 Gabapentinum Capsules 300 mg Parke Davis GmbH 31/12/08<br />

9122 Neurontin 400 Gabapentinum Capsules 400 mg Parke Davis GmbH 31/12/08<br />

9123 Neurontin 600 Gabapentinum Film-coated tablets 600 mg Pfizer Polska Sp. z o.o. 31/12/08<br />

9124 Neurontin 800 Gabapentinum Film-coated tablets 800 mg Pfizer Polska Sp. z o.o. 31/12/08<br />

9126 Neurorubine Thiamini<br />

hydrochloridum,<br />

Pyridoxini<br />

hydrochloridum,<br />

Cyanocobalaminum<br />

9125 Neurorubine Thiamini<br />

hydrochloridum,<br />

Pyridoxini<br />

hydrochloridum,<br />

Cyanocobalaminum<br />

Film-coated tablets 200 + 50 mg +<br />

1mg<br />

Solution for<br />

intramuscular<br />

injection<br />

10 mg + 100 +<br />

1mg<br />

Mepha Pharma AG 31/12/08<br />

Mepha Pharma AG 31/12/08<br />

9127 Neurosina Herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

9128 Neurosina Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

30/10/05<br />

30/10/05<br />

9129 Neurotop retard 300 Carbamazepinum Tablets 300 mg Gerot Pharmazeutika GmbH 31/07/04<br />

9130 Neurotop retard 600 Carbamazepinum Tablets 600 mg Gerot Pharmazeutika GmbH 31/07/04


EN<br />

1144 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9131 Neutra-PMSG Przeciwciała<br />

monoklonalne przeciw<br />

PMSG<br />

Solution for veterinary<br />

use<br />

Intervet 31/12/08<br />

9132 Nevigramon Acidum nalidixicum Capsules 500mg Chinoin Pharmaceutical and<br />

Chemical Works Co. Ltd.<br />

9133 Newcastle Vaccine Lasota szczepionka dla kur<br />

przeciw rzekomemu<br />

pomorowi drobiu<br />

9134 Newvaxidrop Szczepionka przeciw<br />

rzekomemu pomorowi<br />

drobiu i syndromowi<br />

spadku nies´nos´ci dla<br />

kur<br />

9135 Nexium Esomeprazolum Gastro-resistant<br />

tablets<br />

9136 Nexium Esomeprazolum Gastro-resistant<br />

tablets<br />

Lyophilisate for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Lohmann Animal Health<br />

International<br />

30/06/04<br />

31/12/08<br />

Merial 14/06/04<br />

20 mg AstraZeneca AB 27/09/06<br />

40 mg AstraZeneca AB 27/09/06<br />

9137 Niacyn Acidum nicotinicum Tablets 250mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

31/01/06<br />

9138 Niar Selegilinum Tablets 5 mg Abbott GmbH & Co KG 31/05/04<br />

9139 Nicergolin Nicergolinum Tablets 10 mg Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

9140 Nicergolinum Nicergolinum Film-coated tablets 10 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

9141 Nicergolinum Nicergolinum Film-coated tablets 30 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

9142 Nicerin Nicergolinum Film-coated tablets 10 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

9143 Nicerin Nicergolinum Tablets 10 mg; 30 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

9144 Nicofree Capsules Guaranae extractum Capsules 10 mg G.R. Lane Health Products<br />

Ltd.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/10/05<br />

31/12/08<br />

30/04/04<br />

9145 Nicorette Nicotinum Chewing gum 2 mg Pharmacia A.B. 31/01/05<br />

9146 Nicorette Nicotinum Chewing gum 4 mg Pharmacia A.B. 31/01/05<br />

9147 Nicorette Nicotinum Transdermal patch 16.6 mg,<br />

10mg/16h<br />

9148 Nicorette Nicotinum Transdermal patch 24.9 mg,<br />

15mg/16h<br />

9149 Nicorette Nicotinum Transdermal patch 8.3 mg, 5mg/<br />

16h<br />

Pharmacia A.B. 30/06/04<br />

Pharmacia A.B. 30/06/04<br />

Pharmacia A.B. 30/06/04<br />

9150 Nicorette Inhalator Nicotinum Inhalation insert 10 mg Pharmacia AB 14/02/07<br />

9151 Nicorette Inhalator Nicotinum Inhalation insert 15 mg Pharmacia AB 14/02/07<br />

9152 Nicorette Microtab Nicotinum Sublingual tablets 2 mg Pharmacia AB 6/06/07<br />

9153 Nicorette Microtab Nicotinum Sublingual tablets 4 mg Pharmacia AB 6/06/07<br />

9154 Nicorette Mint Nicotinum Chewing gum 2 mg Pharmacia A.B. 30/04/04<br />

9155 Nicorette Mint Nicotinum Chewing gum 4 mg Pharmacia A.B. 30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1145<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9156 Nicotiana comp. Amp. 1ml WALA-Heilmittel GmbH 24/05/07<br />

9157 Nicotiana comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

9158 Nicotinell Nicotinum Chewing gum 2 mg Novartis Consumer Health<br />

S.A.<br />

9159 Nicotinell Nicotinum Chewing gum 4 mg Novartis Consumer Health<br />

S.A.<br />

9160 Nicotinell Nicotinum Chewing gum 2 mg Novartis Consumer Health<br />

S.A.<br />

9161 Nicotinell Nicotinum Chewing gum 4 mg Novartis Consumer Health<br />

S.A.<br />

9162 Nicotinell TTS 10 Nicotinum Transdermal patch 17.5 mg, 7mg/<br />

24h<br />

9163 Nicotinell TTS 20 Nicotinum Transdermal patch 35 mg, 14mg/<br />

24h<br />

9164 Nicotinell TTS 30 Nicotinum Transdermal patch 52.5 mg,<br />

21mg/24h<br />

Novartis Consumer Health<br />

S.A.<br />

Novartis Consumer Health<br />

S.A.<br />

Novartis Consumer Health<br />

S.A.<br />

9165 Nicotol Alcohol nicotynylicus Tablets 25 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/05/04<br />

31/05/04<br />

31/05/04<br />

31/05/04<br />

31/07/04<br />

31/07/04<br />

31/07/04<br />

31/12/05<br />

9166 Niestrawnos´ć HomeoPorady Laboratoires BOIRON 30/06/07<br />

9167 Nifecard SR Nifedipinum Prolonged release<br />

tablets<br />

9168 Nifecard SR Nifedipinum Prolonged release<br />

tablets<br />

9169 Nifedicor retard Nifedipinum Film-coated, prologed<br />

release tablets<br />

30 mg Lek Pharmaceuticals d.d. 24/08/05<br />

60 mg Lek Pharmaceuticals d.d. 24/08/05<br />

20 mg Alfa Wassermann S.p.A. 30/06/05<br />

9170 Nifedipine Nifedipinum Capsules 10 mg Norton Healthcare Ltd. 30/06/04<br />

9171 Nifedipine Nifedipinum Film-coated tablets 10 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/11/05<br />

9172 Nifedypina Denk Nifedipinum Tablets 10 mg E. Denk OHG 31/12/08<br />

9173 Nifedypina Denk Nifedipinum Tablets 20 mg E. Denk OHG 31/12/08<br />

9174 Nifedypina Denk Nifedipinum Tablets 40 mg E. Denk OHG 31/12/08<br />

9175 Nifegis, Cordaflex Nifedipinum Prolonged release<br />

tablets<br />

20 mg Egis Pharmaceuticals Ltd. 25/05/05<br />

9176 Nifuratio Retard Nitrofurantoinum Capsules 100 mg Ratiopharm GmbH 30/04/04<br />

9177 Nifuroksazyd Nifuroxazidum Film-coated tablets 100 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

9179 Nifuroksazyd Nifuroxazidum Oral suspension 220 mg/ 5 ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

9180 Nifuroksazyd Nifuroxazidum Oral suspension 220 mg/5ml Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

9178 Nifuroksazyd Nifuroxazidum Tablets 100 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

9181 Nifuroxazide Nifuraxozidum Syrup 220 mg /5ml Aflofarm 31/12/08<br />

9182 Nifursol 50 % Nifursol Premix for veterinary<br />

use<br />

Vet-Agro 31/12/08


EN<br />

1146 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9183 Nigersan D5 iniekcje Sanum-Kehlbeck 31/12/05<br />

9184 Nigersan D5 krople Sanum-Kehlbeck 31/12/05<br />

9185 Nilogrin Nicergolinum Film-coated tablets 10 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

9186 Nilogrin Nicergolinum Film-coated tablets 30 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

9187 Nimbex Cisatracurium Solution for injection<br />

and for intravenous<br />

infusion<br />

9188 Nimbex Forte Cisatracurium Solution for injection<br />

and for intravenous<br />

infusion<br />

9189 Nimesil Nimesulidum Granules for oral<br />

solution<br />

2 mg/1ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

5 mg/1ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

100 mg Laboratori Guidotti SpA<br />

(Menarini Group)<br />

31/12/05<br />

31/12/05<br />

31/05/04<br />

31/05/04<br />

31/12/08<br />

9191 Nimotop S Nimodipinum Film-coated tablets 30 mg Bayer AG 31/07/04<br />

9190 Nimotop S Nimodipinum Solution for<br />

intravenous injection<br />

0.2 mg/ml Bayer AG 31/07/04<br />

9192 Ninghong Instant herbal tea Jiangxi Provincial Ninghong<br />

Group<br />

9193 Nipas Acidum acetylsalicylicum Dental tablets 32 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

9194 Nipoxime 100 soluble Collistinum Powder for veterinary<br />

use<br />

9195 Nipoxime 40 premix Collistinum Premix for veterinary<br />

use<br />

31/12/08<br />

30/10/05<br />

Andersen 31/12/08<br />

Andersen 31/12/08<br />

9197 Niquitin Nicotinum Buccal lozenge 2 mg SmithKline Beecham<br />

Consumer Healthcare Glaxo<br />

SmithKline Export Ltd.<br />

9196 Niquitin Nicotinum Buccal lozenge 4 mg SmithKline Beecham<br />

Consumer Healthcare Glaxo<br />

SmithKline Export Ltd.<br />

9198 Niquitin Nicotinum Transdermal patch 14 mg/24 h SmithKline Beecham<br />

Consumer Healthcare<br />

9199 Niquitin Nicotinum Transdermal patch 21 mg/24 h SmithKline Beecham<br />

Consumer Healthcare<br />

9200 Niquitin Nicotinum Transdermal patch 7 mg/24 h SmithKline Beecham<br />

Consumer Healthcare<br />

9201 Niquitin o smaku mie˛towym Nicotinum Chewing gum 2 mg GlaxoSmithKline Consumer<br />

Healthcare<br />

9202 Niquitin o smaku mie˛towym Nicotinum Chewing gum 4 mg GlaxoSmithKline Consumer<br />

Healthcare<br />

9203 Niquitin Przezroczysty Nicotinum Transdermal patch 36 mg, 7 mg/<br />

24 h<br />

9204 Niquitin Przezroczysty Nicotinum Transdermal patch 78 mg, 14 mg/<br />

24 h<br />

9205 Niquitin Przezroczysty Nicotinum Transdermal patch 114 mg,<br />

21 mg/24 h<br />

9206 Niratil 20 % pour-on Lewamizolum Solution for veterinary<br />

use<br />

GlaxoSmithKline Consumer<br />

Healthcare<br />

GlaxoSmithKline Consumer<br />

Healthcare<br />

GlaxoSmithKline Consumer<br />

Healthcare<br />

4/07/07<br />

4/07/07<br />

31/10/04<br />

31/10/04<br />

31/10/04<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Virbac 23/11/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1147<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9207 Nitracor Glyceroli trinitras Intravenous injection<br />

(solution)<br />

9208 Nitracor Glyceroli trinitras Intravenous injection<br />

(solution)<br />

10 mg/5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

5 mg/2,5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

9209 Nitrazepam Nitrazepamum Tablets 5 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

9210 Nitrendipine Nitrendipinum Tablets 10 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

9211 Nitrendipine Nitrendipinum Tablets 20 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

9212 Nitrendypina Nitrendipinum Tablets 10 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

9213 Nitrendypina Nitrendipinum Tablets 20 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/12/08<br />

31/12/08<br />

31/12/05<br />

31/12/08<br />

31/12/08<br />

31/12/05<br />

31/12/05<br />

9214 Nitrendypina Nitrendypinum Tablets 20 mg Aflofarm 31/12/08<br />

9215 Nitrendypina Nitrendypinum Tablets 10 mg Aflofarm 31/12/08<br />

9216 Nitrocard Glyceroli trinitras Ointment 20 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

9217 Nitroderm TTS 5 Glyceroli trinitras Transdermal patch 25 mg, 5mg/<br />

24h<br />

9218 Nitroderm TTS 10 Glyceroli trinitras Transdermal patch 50 mg, 10mg/<br />

24h<br />

9219 Nitro-Dur Glyceroli trinitras Transdermal patch 120 mg<br />

(0,6mg/h)<br />

9220 Nitro-Dur Glyceroli trinitras Transdermal patch 40 mg<br />

(0,2mg/h)<br />

9221 Nitro-Dur Glyceroli trinitras Transdermal patch 80 mg<br />

(0,4mg/h)<br />

30/06/06<br />

Novartis Pharma AG 31/05/04<br />

Novartis Pharma AG 31/05/04<br />

Schering-Plough S.A. 31/07/05<br />

Schering-Plough S.A. 31/07/05<br />

Schering-Plough S.A. 31/07/05<br />

9223 Nitrofurazon Nitrofuralum Medicated powder 2 mg/g Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

9222 Nitrofurazon Nitrofuralum Ointment 2 mg/g Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

9224 Nitroglycerinum 0,5 Glyceroli trinitras Sublingual tablets 0.5 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

9225 Nitroglycerinum prolongatum Glyceroli trinitras Prolonged release<br />

tablets<br />

9226 Nitroglycerinum prolongatum Glyceroli trinitras Prolonged release<br />

tablets<br />

9<strong>227</strong> Nitroglycerinum prolongatum Glyceroli trinitras Prolonged release<br />

tablets<br />

2.6 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

6,4mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

6,4mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

30/09/05<br />

30/09/05<br />

30/06/05<br />

25/04/07<br />

31/01/06<br />

25/04/07


EN<br />

1148 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9228 Nitro-Mack Glyceroli trinitras Solution for<br />

intravenous infusion<br />

1 mg/ml Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

30/06/04<br />

9229 Nitromint Glyceroli trinitras Sublingual spray 0.4 mg/dawke˛ Egis Pharmaceuticals Ltd. 30/06/04<br />

9230 Nivalin Galantaminum Solution for injection 2.5 mg/1 ml Pharmachim-Holding AD 30/06/04<br />

9231 Nivalin Galantaminum Solution for injection 5 mg/1 ml Pharmachim-Holding AD 30/06/04<br />

9232 Nizopol Ketokonazolum Shampoo 20 mg / ml Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

31/12/08<br />

9233 Nizoral Ketoconazolum Cream 20 mg/g Janssen-Cilag N.V. 24/05/06<br />

9234 Nizoral Ketoconazolum Shampoo 10 mg/g Janssen Pharmaceutica N.V. 31/12/08<br />

9235 Nizoral Ketoconazolum Shampoo 20 mg/g Janssen Pharmaceutica N.V. 31/07/04<br />

9236 Nizoral Ketoconazolum Shampoo and<br />

conditioner<br />

20 mg/g Janssen Pharmaceutica N.V. 30/11/04<br />

9237 Nizoral Ketoconazolum Tablets 200 mg Janssen Pharmaceutica N.V. 30/06/04<br />

9240 Nobaxin Azithromycinum Film-coated tablets 125mg,<br />

250 mg i<br />

500 mg<br />

9238 Nobaxin Azithromycinum Mixture for oral<br />

suspension<br />

9239 Nobaxin Azithromycinum Mixture for oral<br />

suspension<br />

9241 Nobilis AE 1143 Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

mózgu i rdzenia<br />

kre˛gowego kur<br />

9242 Nobilis AE+POX Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

mózgu i rdzenia<br />

kurcza˛t oraz ospie kur<br />

i indyków<br />

9243 Nobilis CAV P4 Szczepionka przeciw<br />

zakaz´nej anemii<br />

kurcza˛t<br />

9244 Nobilis E.coli inac Szczepionka przeciw<br />

kolibakteriozie kur<br />

9245 Nobilis EDS Szczepionka przeciw<br />

syndromowi spadku<br />

nies´nos´ci dla kur<br />

9246 Nobilis FC inac Szczepionka przeciw<br />

pasterelozie dla kur,<br />

indyków, ge˛si i kaczek<br />

9247 Nobilis Gumboro 228 E Szczepionka przeciw<br />

chorobie Gumboro dla<br />

kur<br />

9248 Nobilis Gumboro D78 Szczepionka przeciw<br />

chorobie Gumboro dla<br />

kur<br />

9249 Nobilis IB 4-91 Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli dla kur<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

100 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

200 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Intervet 21/05/04<br />

Intervet 24/05/04<br />

Intervet 29/09/05<br />

Intervet 29/08/05<br />

Intervet 31/12/08<br />

Intervet 24/05/04<br />

Intervet 24/05/04<br />

Intervet 24/05/04<br />

Intervet 18/08/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1149<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9250 Nobilis IB D 1466 Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli kur<br />

9251 Nobilis IB D 274 Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli kur<br />

9252 Nobilis IB Ma5 Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli dla kur<br />

9253 Nobilis IB multi + G + ND Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli, chorobie<br />

Gumboro, rzekomemu<br />

pomorowi drobiu dla<br />

kur<br />

9254 Nobilis IB+G+ND Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli, chorobie<br />

Gumboro, rzekomemu<br />

pomorowi drobiu dla<br />

kur<br />

9255 Nobilis IB+ND+EDS Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli, rzekomemu<br />

pomorowi drobiu,<br />

syndromowi spadku<br />

nies´nos´ci dla kur<br />

9256 Nobilis IB3+G+ND Szczepionka dla s´wiń<br />

przeciw zakaz´nemu<br />

zapaleniu oskrzeli,<br />

chorobie Gumboro i<br />

rzekomemu pomorowi<br />

drobiu<br />

9257 Nobilis ILT Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

krtani i tchawicy dla<br />

kur<br />

9258 Nobilis Ma 5 + Hitchner B1 Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli i rzekomemu<br />

pomorowi drobiu dla<br />

kurcza˛t<br />

9259 Nobilis Ma5+Clone 30 Szczepionka przeciw<br />

rzekomemu pomorowi<br />

drobiu i zakaz´nemu<br />

zapaleniu oskrzeli dla<br />

kur<br />

9260 Nobilis Marek THV lyo Szczepionka przeciw<br />

chorobie Mareka<br />

9261 Nobilis Marexine — 89/03 Szczepionka dla<br />

kurcza˛t przeciw<br />

chorobie Mareka i<br />

chorobie Gumboro<br />

9262 Nobilis Marexine CA 126 Szczepionka<br />

przeciwko chorobie<br />

Mareka dla kurcza˛t<br />

9263 Nobilis MG 6/85 Szczepionka dla kur<br />

przeciw zakaz˙eniom<br />

wywołanym przez<br />

Mycoplasma<br />

gallisepticum<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Suspension + solvent for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Intervet 30/06/04<br />

Intervet 21/06/04<br />

Intervet 24/05/04<br />

Intervet International B.V. 14/08/05<br />

Intervet 24/05/04<br />

Intervet 22/03/05<br />

Intervet 30/06/04<br />

Intervet 24/05/04<br />

Intervet Inc. 27/03/05<br />

Intervet 24/05/04<br />

Intervet 31/12/08<br />

Intervet International B.V. 31/12/08<br />

Intervet 31/12/08<br />

Intervet International B.V. 8/11/05


EN<br />

1150 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9264 Nobilis MG inac Szczepionka przeciw<br />

zakaz˙eniom<br />

wywołanym przez<br />

Mycoplasma<br />

gallisepticum dla kur<br />

9265 Nobilis ND Clone 30 Szczepionka przeciw<br />

rzekomemu pomorowi<br />

drobiu dla kur<br />

9266 Nobilis New Hatch C2 szczepionka dla kur<br />

przeciwko rzekomemu<br />

pomorowi drobiu<br />

9267 Nobilis Pigeon POX Szczepionka przeciw<br />

ospie gołe˛bi<br />

9268 Nobilis Reo + IB + G + ND Szczepionka dla kur<br />

przeciw zakaz˙eniom<br />

reowirusowym,<br />

zakaz´nemu zapaleniu<br />

oskrzeli, rzekomemu<br />

pomorowi drobiu<br />

9269 Nobilis Reo 1133 Szczepionka przeciw<br />

zakaz˙eniom<br />

reowirusowym dla kur<br />

9270 Nobilis Reo inac Szczepionka przeciw<br />

zakaz˙eniom<br />

reowirusowym dla kur<br />

9271 Nobilis Rismavac Szczepionka przeciw<br />

chorobie Mareka dla<br />

kurcza˛t<br />

9272 Nobilis Rismavac + CA 126 Szczepionka przeciw<br />

chorobie Mareka<br />

9273 Nobilis RT+IB multi +ND+EDS Inaktywowana<br />

szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu nosa i<br />

tchawicy indyków,<br />

zakaz´nemu zapaleniu<br />

oskrzeli, rzekomemu<br />

pomorowi drobiu i<br />

syndromowi spadku<br />

nies´nos´ci<br />

9274 Nobilis RT+IB multi+G+ND Inaktywowana<br />

szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu nosa i<br />

tchawicy indyków,<br />

zakaz´nemu zapaleniu<br />

oskrzeli, chorobie<br />

Gumboro i<br />

rzekomemu pomorowi<br />

drobiu<br />

9275 Nobilis RTV 8544 Atenuowana<br />

szczepionka dla kur<br />

przeciw syndromowi<br />

wielkiej głowy<br />

9276 Nobilis SG 9R Szczepionka dla kur<br />

przekiwko zakaz˙eniom<br />

Salmonella enteritidis<br />

9277 Nobilis TRT Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

nosa i tchawicy<br />

indyków<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Suspension + solvent for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Intervet 24/05/04<br />

Intervet 14/06/04<br />

Intervet International 31/12/08<br />

Intervet 24/05/04<br />

Intervet 22/03/05<br />

Intervet 31/12/08<br />

Intervet 31/12/08<br />

Intervet 31/12/08<br />

Intervet 31/12/08<br />

Intervet International B.V. 9/02/06<br />

Intervet International B.V. 9/02/06<br />

Intervet International 14/11/06<br />

Intervet International 31/12/08<br />

Intervet 7/09/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1151<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9278 Nobilis TRT + ND Szczepionka<br />

przeciwko zakaz´nemu<br />

zapaleniu nosa i<br />

tchawicy oraz<br />

rzekomemu pomorowi<br />

drobiu dla indyków<br />

9279 Nobilis TRT inac Szczepionka dla kur i<br />

indyków przeciw<br />

zakaz˙eniom<br />

wywołanym przez<br />

wirus zakaz´nego<br />

zapalenia nosa i<br />

tchawicy indyków TRT<br />

9280 Nobivac DHP Szczepionka przeciw<br />

chorobie Rubartha i<br />

parwowirusowej<br />

chorobie psów<br />

9281 Nobivac DHPPI Szczepionka przeciw<br />

nosówce,<br />

parwowirozie,<br />

parainfluenzie i<br />

chorobie Rubartha<br />

9282 Nobivac LC Szczepionka dla psów<br />

przeciw zakaz˙eniom<br />

koronawirusowym i<br />

leptospirozie<br />

9283 Nobivac Lepto Szczepionka przeciw<br />

leptospirozie psów<br />

9284 Nobivac Parvo C Szczepionka dla psów<br />

przeciw<br />

parwowirusowej<br />

chorobie psów<br />

9285 Nobivac Puppy DP Szczepionka przeciw<br />

nosówce i<br />

parwowirusowej<br />

chorobie psów<br />

9286 Nobivac Rabies Szczepionka przeciw<br />

ws´ciekliz´nie<br />

9287 Nobivac Rabies Szczepionka przeciw<br />

ws´ciekliz´nie<br />

9288 Nobivac Tricat Szczepionka przeciw<br />

wirusowemu zapaleniu<br />

nosa i tchawicy,<br />

kociemu<br />

kaliciwirusowi i<br />

panleukopenii<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Intervet International B.V. 24/02/05<br />

Intervet 7/09/04<br />

Intervet 31/12/08<br />

Intervet 31/12/08<br />

Intervet International 28/05/06<br />

Intervet 24/05/04<br />

Intervet International 31/12/08<br />

Intervet 31/12/08<br />

Biowet Puławy 31/12/08<br />

Intervet 31/12/08<br />

Intervet 31/12/08<br />

9289 Noctofer Lormetazepamum Tablets 0.5 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

9290 Noctofer Lormetazepamum Tablets 1 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/05<br />

31/12/05<br />

9291 Noell Ketoconazolum Shampoo 20 mg/g Polfarmex S.A. 31/12/08<br />

9292 Noksid Nimesulidum Tablets 100 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

9293 Noksid Nimesulidum Gel 1 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/08<br />

9294 Nolicin Norfloxacinum Tablets 400 mg Krka d.d., Novo mesto 30/04/04


EN<br />

1152 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9295 Noliprel Indapamidum +<br />

Perindoprilum<br />

erbuminum<br />

9296 Noliprel Forte Indapamidum +<br />

Perindoprilum<br />

erbuminum<br />

Tablets 0,625mg +<br />

2mg<br />

Les Laboratoires Servier 31/05/04<br />

Tablets 1,25mg + 4mg Les Laboratoires Servier 31/12/08<br />

9297 Nolvadex Tamoxifenum Film-coated tablets 10 mg AstraZeneca UK Ltd. 30/06/04<br />

9298 Nolvadex D Tamoxifenum Film-coated tablets 20 mg AstraZeneca UK Ltd. 30/06/04<br />

9301 Nootropil Piracetamum Capsules 400 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/11/05<br />

9302 Nootropil Piracetamum Capsules 400 mg UCB S.A. Pharma Sector 30/06/04<br />

9307 Nootropil Piracetamum Film-coated tablets 1200 mg UCB S.A. Pharma Sector 30/06/04<br />

9308 Nootropil Piracetamum Film-coated tablets 400 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/11/05<br />

9309 Nootropil Piracetamum Film-coated tablets 800 mg UCB S.A. Pharma Sector 30/06/04<br />

9299 Nootropil Piracetamum Granules for oral<br />

solution<br />

9300 Nootropil Piracetamum Granules for oral<br />

solution<br />

1.2 g/2,5 g UCB S.A. Pharma Sector 31/12/08<br />

2.4 g/5 g UCB S.A. Pharma Sector 31/12/08<br />

9303 Nootropil Piracetamum Solution for injection 3 g/15 ml UCB S.A. Pharma Sector 31/12/08<br />

9305 Nootropil Piracetamum Solution for injection 200 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

9306 Nootropil Piracetamum Solution for injection 200 mg/ml UCB S.A. Pharma Sector 30/06/04<br />

9304 Nootropil Piracetamum Solution for<br />

intravenous infusion<br />

12 g/60 ml UCB S.A. Pharma Sector 30/06/04<br />

9310 Nootropil 20 % Piracetamum Oral solution 200 mg/ml UCB S.A. Pharma Sector 30/06/04<br />

9311 Nootropil 33 % Piracetamum Oral solution 333 mg/ml UCB S.A. Pharma Sector 30/06/04<br />

9313 Norbactin Norfloxacinum Film-coated tablets 400 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

9312 Norbactin Norfloxacinum Tablets 800 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

9314 Norcholesterol (131 I)<br />

Injection<br />

Preparat<br />

radiofarmaceutyczny<br />

9315 Norcuron Vecuronium Powder and solvent<br />

for solution for<br />

intravenous injection<br />

9316 Norcuron Vecuronium Substance for solution<br />

for intravenous<br />

injection<br />

9317 Norditropin Pen Set 12 Somatropinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

9318 Norditropin Pen Set 24 Somatropinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

9319 Norditropin Simplex Xx<br />

10 mg/1,5 ml<br />

30/04/04<br />

30/04/04<br />

Mallinckrodt Medical B.V. 31/12/08<br />

4 mg Organon N.V. 31/05/04<br />

10 mg Organon N.V. 31/05/04<br />

12 j.m. Novo Nordisk A/S 31/07/04<br />

24 j.m. Novo Nordisk A/S 31/07/04<br />

Somatropinum Solution for injection 10 mg/1,5 ml Novo Nordisk A/S 25/05/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1153<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9320 Norditropin Simplex Xx<br />

15 mg/1,5 ml<br />

9321 Norditropin Simplex Xx 5 mg/<br />

1,5 ml<br />

Somatropinum Solution for injection 15 mg/1,5 ml Novo Nordisk A/S 25/05/05<br />

Somatropinum Solution for injection 5 mg/1,5 ml Novo Nordisk A/S 25/05/05<br />

9322 Norethisteron Norethisteronum Tablets 5 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

9323 Norfloksacyna Scholz, Sowin 24/09/05<br />

9324 Norfloxacyna 10 % Norfloksacyna Solution for veterinary<br />

use<br />

PFO Vetos Farma 8/03/06<br />

9325 Norit Carbo medicinalis Tablets 125 mg Norit Nederland B.V. 31/12/08<br />

9326 Normacol Enema dla<br />

dorosłych<br />

Natrii dihydrophosphas<br />

+ Natrii hydrophosphas<br />

9327 Normacol Enema dla dzieci Natrii dihydrophosphas<br />

+ Natrii hydrophosphas<br />

Rectal infusion (23,66 g +<br />

10,4 g)/130 ml<br />

Rectal infusion (10,92 g +<br />

4,8 g)/60 ml<br />

Norgine Pharma 31/12/08<br />

Norgine Pharma 31/12/08<br />

9328 Normalac Lactulosum Syrup 667 mg/ml Molteni Farmaceutici Polska<br />

Sp. z o.o.<br />

9329 Normanol Herbal granules Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

9330 Normase Lactulosum Syrup 667 mg/ml L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

9331 Normatens Clopamidum +<br />

Dihydroergocristinum +<br />

Reserpinum<br />

30/06/07<br />

30/10/05<br />

31/07/04<br />

Coated tablets ICN Polfa Rzeszów S.A. 30/06/06<br />

9332 Normin fix Herbal tea Herbapol Lublin S.A. 31/12/07<br />

9334 Normix Rifaximinum Film-coated tablets 200 mg Medial Polska Sp. z o.o. 31/12/08<br />

9333 Normix Rifaximinum Granules for oral<br />

solution<br />

100 mg/5 ml Medial Polska Sp. z o.o. 31/12/08<br />

9335 Normocard Atenololum Tablets 100 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

9336 Normocard Atenololum Tablets 25 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

9337 Normocard Atenololum Tablets 50 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/05/05<br />

6/12/06<br />

31/05/05<br />

9338 Normodipine Amlodipinum Tablets 10 mg Gedeon Richter Ltd. 29/11/06<br />

9339 Normodipine Amlodipinum Tablets 5 mg Gedeon Richter Ltd. 29/11/06<br />

9340 Normoglaucon Metipranololum +<br />

Pilocarpinum<br />

Eye drops, solution Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

9341 Normogran Preparat ziołowy Herbal granules Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

9342 Normolax Frangulae cortex +<br />

Sennae folium<br />

30/01/05<br />

30/10/05<br />

Tablets for infuse Herbapol Łódz´ S.A. 30/09/07<br />

9343 Normomix Herba Oskar, Wierzbówiec 31/12/08<br />

9344 Normosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

9345 Normosan fix Mieszanka ziołowa Instant herbal tea Herbapol Łódz´ S.A. 31/03/07


EN<br />

1154 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9346 Normovit Herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

9347 Normovit Instant herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

30/10/05<br />

30/10/05<br />

9348 Norprolac Quinagolidum Tablets 150 mcg Novartis Pharma AG 25/09/06<br />

9349 Norprolac Quinagolidum Tablets 75 mcg Novartis Pharma AG 25/09/06<br />

9350 Norprolac Quinagolidum Tablets 25mcg +<br />

50mcg<br />

Novartis Pharma AG 25/09/06<br />

9351 Norsept Norfloxacinum Tablets 400 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

9352 Norserin Mianserinum Film-coated tablets 10 mg Norton Healthcare Ltd. 30/06/04<br />

9353 Norserin Mianserinum Film-coated tablets 20 mg Norton Healthcare Ltd. 31/12/08<br />

9354 Norserin Mianserinum Film-coated tablets 30 mg Norton Healthcare Ltd. 31/12/08<br />

9355 Norsulin Gliclazidum Tablets 80 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

9356 Norsulin Mr Gliclazidum Modified release<br />

tablets<br />

9357 Nortril 10 % Norfloksacyna Solution for veterinary<br />

use<br />

30 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

12/10/05<br />

31/12/08<br />

Bremer Pharma 18/09/05<br />

9358 Norvasc Amlodipinum Tablets 10 mg Pfizer Limited Of Ramsgate<br />

Road<br />

9359 Norvasc Amlodipinum Tablets 5 mg Pfizer Limited Of Ramsgate<br />

Road<br />

30/04/04<br />

30/04/04<br />

9361 Norvir Ritonavirum Capsules 100 mg Abbott Laboratories Ltd. 31/12/08<br />

9360 Norvir Ritonavirum Capsules, soft 100 mg Abbott Laboratories Ltd. 27/04/05<br />

9362 Norvir Ritonavirum Oral solution 80 mg/ml Abbott Laboratories Ltd. 31/12/08<br />

9363 NO-SPA Drotraverini<br />

hydrochloridum<br />

9364 NO-SPA Drotraverini<br />

hydrochloridum<br />

9365 NO-SPA Drotraverini<br />

hydrochloridum<br />

9366 No-Spa forte Drotraverini<br />

hydrochloridum<br />

9367 No-Spa forte Drotraverini<br />

hydrochloridum<br />

Solution for<br />

subcutaneous,<br />

intramuscular,<br />

intravenous injection<br />

20 mg/1 ml Chinoin Pharmaceutical and<br />

Chemical Works Co. Ltd.<br />

Tablets 40 mg Chinoin Pharmaceutical and<br />

Chemical Works Co. Ltd.<br />

30/04/04<br />

30/04/04<br />

Tablets 40 mg Sanofi-Synthelabo Sp. z o.o. 30/10/05<br />

Solution for injection 20 mg/ml Chinoin Pharmaceutical and<br />

Chemical Works Co. Ltd.<br />

Tablets 80 mg Chinoin Pharmaceutical and<br />

Chemical Works Co. Ltd.<br />

9368 Nospicin Drotaverinum Tablets 40 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

9369 Nospicin Forte Drotaverinum Tablets 80 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

14/12/05<br />

14/12/05<br />

31/12/08<br />

31/12/08<br />

9370 Notakehl D5 iniekcje Sanum-Kehlbeck 31/12/05<br />

9371 Notakehl D5 krople Sanum-Kehlbeck 31/12/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1155<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9372 Notis 20 Omeprazolum Gastro-resistant<br />

capsules, hard<br />

20 mg CEPA Schwarz Pharma S.L. 24/08/05<br />

9373 Notta Drops Richard Bittner 9/09/07<br />

9374 Nova — Dip Jodyna Liquid for veterinary<br />

use<br />

9375 Noval Preparat ziołowy Inhalation vapour,<br />

solution<br />

9377 Novalox Aluminii glicynas +<br />

Magnesii oxydum<br />

9376 Novalox Aluminii glicynas +<br />

Magnesii oxydum<br />

9378 Novamox Amoxicillinum Powder for oral<br />

suspension<br />

Novadan A/S 31/12/08<br />

Nova s.c. 30/10/05<br />

Oral suspension SANTA N Balanos S.A. 31/12/08<br />

Tablets 300 mg +<br />

100 mg<br />

SANTA N Balanos S.A. 31/12/08<br />

250 mg/5ml Hexal AG 15/03/06<br />

9379 Novamox 1000 Amoxicillinum Film-coated tablets 1 g Hexal AG 15/03/06<br />

9380 Novamox 500 Amoxicillinum Film-coated tablets 500 mg Hexal AG 15/03/06<br />

9381 Novamox 750 Amoxicillinum Film-coated tablets 750 mg Hexal AG 15/03/06<br />

9382 Novasen Acidum acetylsalicylicum Gastro-resistant<br />

tablets<br />

9383 Novasen Acidum acetylsalicylicum Gastro-resistant<br />

tablets<br />

9384 Novaspryn Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

325 mg Novopharm Ltd. 30/04/04<br />

650 mg Novopharm Ltd. 30/04/04<br />

0.325 g Time-Cap Laboratories Ltd. 31/12/07<br />

9385 Novate Clobetasolum Cream 0.5 mg/g Blau Farma Sp. z o.o. Spółka<br />

Komandytowa<br />

9386 Novate Clobetasolum Ointment 0.5 mg/g Blau Farma Sp. z o.o. Spółka<br />

Komandytowa<br />

9387 Novatec Lisinoprilum Tablets 5 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

9388 Novatec Lisinoprilum Tablets 10 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

9389 Novatec Lisinoprilum Tablets 20 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

9390 Noverban Verbasci floris extractum<br />

fluidum<br />

9391 Noveril Dibenzepinum Modified release<br />

tablets<br />

Syrup 958 mg/5 ml Prolab s.c. — Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Produkcyjno-Analityczno-<br />

Handlowe s.c. Paterek<br />

6/12/06<br />

6/12/07<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

9/08/06<br />

240 mg Novartis Pharma AG 31/05/04<br />

9392 Novesin Oxybuprocainum Eye drops 4 mg/ml Novartis Ophthalmics AG<br />

Hettlingen<br />

22/05/05<br />

9393 Novo — Famotidine Famotidinum Film-coated tablets 20 mg Novopharm Ltd. 30/04/04<br />

9394 Novo — Famotidine Famotidinum Film-coated tablets 40 mg Novopharm Ltd. 30/04/04<br />

9395 Novofem Estradiolum +<br />

Norethisteronum<br />

Film-coated tablets Novo Nordisk A/S 4/07/07<br />

9396 Novo-Gesic Paracetamolum Tablets 325 mg Novopharm Ltd. 31/12/08<br />

9397 Novo-Gesic Forte Paracetamolum Tablets 500 mg Novopharm Ltd. 31/12/08


EN<br />

1156 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9398 Novo-Helisen Depot Alergeny grzybów<br />

ples´niowych,<br />

dermatofitów i droz˙dz˙y<br />

Suspension for<br />

subcutaneous<br />

injection<br />

9399 Novo-Helisen Depot Alergeny pokarmowe Suspension for<br />

subcutaneous<br />

injection<br />

9400 Novo-Helisen Depot Alergeny pyłków ros´lin Suspension for<br />

subcutaneous<br />

injection<br />

9401 Novo-Helisen Depot Alergeny roztoczy kurzu<br />

domowego<br />

9402 Novo-Helisen Depot Alergeny róz˙ne —<br />

mieszanina<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

9403 Novo-Helisen Depot Alergeny siers´ci zwierza˛t Suspension for<br />

subcutaneous<br />

injection<br />

9404 Novo-Helisen Oral Alergeny grzybów<br />

ples´niowych,<br />

dermatofitów i droz˙dz˙y<br />

Solution for<br />

oromucosal use<br />

9405 Novo-Helisen Oral Alergeny pokarmowe Solution for<br />

oromucosal use<br />

9406 Novo-Helisen Oral Alergeny pyłków ros´lin Solution for<br />

oromucosal use<br />

9407 Novo-Helisen Oral Alergeny roztoczy kurzu<br />

domowego<br />

9408 Novo-Helisen Oral Alergeny róz˙ne —<br />

mieszanina<br />

Solution for<br />

oromucosal use<br />

Solution for<br />

oromucosal use<br />

9409 Novo-Helisen Oral Alergeny siers´ci zwierza˛t Solution for<br />

oromucosal use<br />

9410 Novomit (poprzednia nazwa<br />

royal travel aid)<br />

9411 NovoMix 30 FlexPen Insulinum aspartum Suspension for<br />

injection<br />

9412 NovoMix 30 Penfill Insulinum aspartum Suspension for<br />

injection<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

VITAMEX AB 31/12/08<br />

100 j.m./ml Novo Nordisk A/S 27/06/07<br />

100 j.m./ml Novo Nordisk A/S 26/04/06<br />

9413 NovoNorm 0,5 Repaglinidum Tablets 0.5 mg Novo Nordisk A/S 31/12/08<br />

9414 NovoNorm 1 Repaglinidum Tablets 1 mg Novo Nordisk A/S 31/12/08<br />

9415 NovoNorm 2 Repaglinidum Tablets 2 mg Novo Nordisk A/S 31/12/08<br />

9416 Novo-Ranidine Ranitidinum Film-coated tablets 150 mg Novopharm Ltd. 31/12/08<br />

9417 Novo-Ranidine Ranitidinum Film-coated tablets 300 mg Novopharm Ltd. 31/12/08<br />

9418 NovoRapid Insulinum aspartum Solution for injection 100 j.m. Novo Nordisk A/S 31/12/08<br />

9419 NovoRapid FlexPen Insulinum aspartum Solution for injection 100 j.m/ml Novo Nordisk A/S 27/06/07<br />

9420 NovoRapid NovoLet Insulinum aspartum Solution for injection 100 j.m. Novo Nordisk A/S 31/12/08<br />

9421 NovoRapid Penfill Insulinum aspartum Solution for injection 100 j.m. Novo Nordisk A/S 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1157<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9422 Novoscabin Benzyli benzoas Coutanous liquid 300 mg/g Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp. z<br />

o.o.<br />

9423 NovoSeven 60 KIU (1,2 mg) Ludzki rekombinowany<br />

czynnik krzepnie˛cia VIIa,<br />

aktywowany,<br />

(Coagulation factor VII)<br />

9424 NovoSeven 120 KIU (2,4 mg) Ludzki rekombinowany<br />

czynnik krzepnie˛cia VIIa,<br />

aktywowany,<br />

(Coagulation factor VII)<br />

9425 NovoSeven 240 KIU (4,8 mg) Ludzki rekombinowany<br />

czynnik krzepnie˛cia VIIa,<br />

aktywowany,<br />

(Coagulation factor VII)<br />

9426 Novothyral Levothyroxinum<br />

natricum +<br />

Liothyroninum natricum<br />

9427 Novothyral 75 Levothyroxinum<br />

natricum +<br />

Liothyroninum natricum<br />

Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

injection<br />

Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

injection<br />

Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

injection<br />

60 Kjm<br />

(1,2 mg)<br />

120 Kjm<br />

(2,4 mg)<br />

240 Kjm<br />

(4,8 mg)<br />

31/01/06<br />

Novo Nordisk A/S 31/12/08<br />

Novo Nordisk A/S 31/12/08<br />

Novo Nordisk A/S 31/12/08<br />

Tablets Merck KGaA 30/06/04<br />

Tablets Merck KGaA 30/06/04<br />

9428 Novo-Veramil Verapamilum Film-coated tablets 120 mg Novopharm Ltd. 31/12/08<br />

9429 Novo-Veramil Verapamilum Film-coated tablets 80 mg Novopharm Ltd. 31/12/08<br />

9430 Novoyesky Z˙ywa szczepionka dla<br />

s´wiń przeciw chorobie<br />

Aujeszky'ego<br />

9431 Novynette Desogestrelum +<br />

Ethinylestradiolum<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Film-coated tablets 0,15mg +<br />

0,02mg<br />

Laboratorios SYVA S.A. 14/11/06<br />

Gedeon Richter Ltd. 30/09/04<br />

9432 Noxoratio Norfloxacinum Film-coated tablets 400 mg ratiopharm GmbH 12/10/05<br />

9433 Nuflor Florfenikol Solution for veterinary<br />

use<br />

9434 Nuflor Drinking Water<br />

Concentrate<br />

Florfenikol Solution for veterinary<br />

use<br />

Schering-Plough Central East<br />

Ag<br />

9435 Nurofen Ibuprofenum Effervescent granules 200 mg Boots Healthcare<br />

International<br />

9437 Nurofen Ibuprofenum Effervescent tablets 200 mg Boots Healthcare<br />

International<br />

9436 Nurofen Ibuprofenum Film-coated tablets 200 mg Boots Healthcare<br />

International<br />

9439 Nurofen Ibuprofenum Gel 50 mg/g Boots Healthcare<br />

International<br />

9438 Nurofen Ibuprofenum Suspension for<br />

children<br />

100 mg/5 ml Boots Healthcare<br />

International<br />

9440 Nurofen Advance Ibuprofenum Film-coated tablets 342 mg Boots Healthcare<br />

International<br />

9442 Nurofen Antigrip Ibuprofenum +<br />

Pseudoephedrinum<br />

9441 Nurofen Antigrip Ibuprofenum +<br />

Pseudoephedrinum<br />

Film-coated tablets Boots Healthcare<br />

International<br />

Granules for oral<br />

solution<br />

17/05/05<br />

Schering Plough 31/12/08<br />

Boots Healthcare<br />

International<br />

9443 Nurofen Forte Ibuprofenum Effervescent granules 400 mg Boots Healthcare<br />

International<br />

30/06/07<br />

31/12/08<br />

30/06/07<br />

31/12/08<br />

31/12/04<br />

31/12/08<br />

31/12/08<br />

15/11/06<br />

31/05/05


EN<br />

1158 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9444 Nurofen Forte Ibuprofenum Film-coated tablets 400 mg Boots Healthcare<br />

International<br />

9445 Nurofen Gel-caps Ibuprofenum Capsules, soft 200 mg Boots Healthcare<br />

International<br />

9446 Nurofen Menstrual Ibuprofenum Prolonged release<br />

capsules<br />

9447 Nurofen Plus Codeinum +<br />

Ibuprofenum<br />

Film-coated tablets 12,8mg +<br />

200mg<br />

9449 Nurofen Topss Ibuprofenum Oromucosal soluble<br />

tablets<br />

300 mg Boots Healthcare<br />

International<br />

Boots Healthcare<br />

International<br />

200 mg Boots Healthcare<br />

International<br />

9448 Nurofen Topss Ibuprofenum Tablets for childeren 100 mg Boots Healthcare<br />

International<br />

9450 Nutramigen Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

9451 Nutramigen Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

Powder Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Powder for solution Mead Johnson b.v. a Bristol<br />

Myers Squibb Company<br />

31/05/05<br />

27/06/07<br />

29/06/05<br />

26/09/07<br />

6/06/07<br />

31/12/08<br />

31/12/05<br />

30/06/04<br />

9452 Nutridrink Preparat odz˙ywczy Liquid N.V. Nutricia 31/03/04<br />

9453 Nutridrink Preparat odz˙ywczy Liquid N.V. Nutricia 31/03/04<br />

9454 Nutridrink (o smaku owoców<br />

tropikalnych)<br />

9455 Nutridrink (o smaku<br />

truskawkowym)<br />

9456 Nutridrink o smaku<br />

waniliowym<br />

9457 Nutriflex Basal Zestaw aminokwasów i<br />

elektrolitów<br />

9458 NuTRIflex Lipid peri Zestaw aminokwasów i<br />

elektrolitów<br />

9459 NuTRIflex Lipid plus Zestaw aminokwasów i<br />

elektrolitów<br />

9460 Nutriflex Peri Zestaw aminokwasów i<br />

elektrolitów<br />

9461 Nutriflex Plus Zestaw aminokwasów i<br />

elektrolitów<br />

9462 Nutriflex Special Zestaw aminokwasów i<br />

elektrolitów<br />

Preparat odz˙ywczy Liquid N.V. Nutricia 20/03/06<br />

Preparat odz˙ywczy Liquid N.V. Nutricia 20/03/06<br />

Preparat odz˙ywczy Liquid N.V. Nutricia 20/03/06<br />

Kit: 2 solutions for<br />

intravenous infusion<br />

Kit: 2 solutions and<br />

emulsion for infusion<br />

Kit: 2 solutions and<br />

emulsion for infusion<br />

Kit: 2 solutions for<br />

intravenous infusion<br />

Kit: 2 solutions for<br />

intravenous infusion<br />

Kit: 2 solutions for<br />

intravenous infusion<br />

B.Braun Medical AG 31/01/05<br />

B. Braun Melsungen AG 14/02/07<br />

B. Braun Melsungen AG 14/02/07<br />

B.Braun Medical AG 31/01/05<br />

B.Braun Medical AG 31/01/05<br />

B.Braun Medical AG 31/01/05<br />

9463 Nutrilan Energy Mct Dieta Nutrichem + Pharma GmbH 31/12/08<br />

9464 Nutrilan Fibre Dieta Nutrichem + Pharma GmbH 31/12/08<br />

9465 Nutrilan Peptid Dieta Nutrichem + Pharma GmbH 31/12/08<br />

9466 Nutrilan Standard Dieta Nutrichem + Pharma GmbH 31/12/08<br />

9467 Nutrini Preparat odz˙ywczy Liquid N.V. Nutricia 30/06/07<br />

9468 Nutrison Energy Preparat odz˙ywczy Liquid N.V. Nutricia 27/02/06<br />

9469 Nutrison Multi Fibre Preparat odz˙ywczy Liquid N.V. Nutricia 27/02/06<br />

9470 Nutrison Standard Preparat odz˙ywczy Liquid N.V. Nutricia 27/02/06<br />

9471 Nutrison w proszku Preparat odz˙ywczy Powder Nutricia Cuijk B.V 20/03/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1159<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9472 Nutrodrip Energy Vanilla Dieta płynna Novartis 31/12/08<br />

9473 Nutrodrip Fiber Multifruit Dieta płynna Novartis 31/12/08<br />

9474 Nutrodrip Fiber Toffee Dieta płynna Novartis 31/12/08<br />

9475 Nutrodrip Protein Multifruit Dieta płynna Novartis 31/12/08<br />

9476 Nutrodrip Protein Vanilla Dieta płynna Novartis 31/12/08<br />

9477 Nuvelle Continuous Estradiolum +<br />

Norethisteronum<br />

9478 Nux Vomica Complexe<br />

Lehning nr 49<br />

Film-coated tablets Schering AG 31/12/08<br />

Drops Lehning Laboratoires 11/11/06<br />

9479 Nux vomica compose krople Dolisos Laboratoires 31/12/08<br />

9480 Nux vomica similiaplex krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

30/11/05<br />

9481 Nux Vomica-Homaccord Drops Heel GmbH 31/12/08<br />

9482 Nux-vomica-Homaccord Amp. Heel GmbH 31/12/08<br />

9483 Nymfalon Gonadotropinum +<br />

Progesteronum<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Intervet 4/05/04<br />

9484 Nyolol 0,1 % Gel Timololum Eye gel 1 mg/g Novartis Ophthalmics AG<br />

Hettlingen<br />

16/05/07<br />

9485 Nystatin Nystatinum Film-coated tablets 500000 j.m. RAO Biopreparat 31/12/04<br />

9486 Nystatyna Nystatinum Coated tablets 500000 j.m. Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

9487 Nystatyna Nystatinum Granules for oral<br />

suspension and for<br />

oromucosal use<br />

2.4e+006 j.m./<br />

5g<br />

Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

9489 Nystatyna Nystatinum Medicated powder 100000 j.m./g Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

9488 Nystatyna Nystatinum Powder for magistral<br />

formula<br />

2e+006 j.m./g Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/11/05<br />

31/12/05<br />

31/12/05<br />

31/01/06<br />

9490 Nystatyna Nystatinum Vaginal tablets 100000 j.m. ICN Polfa Rzeszów S.A. 30/11/05<br />

9491 Nystatyna BUFA b.v. Pharmaceutical<br />

Products<br />

31/05/04<br />

9492 Nystatyna Pharma Cosmetic, Kraków 30/11/05<br />

9493 Nystatyna Pharma Zentrale 30/11/05<br />

9494 Nystatyna PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

9495 Obroz˙a owadobójcza PESS<br />

PER<br />

9496 Obroz˙a owadobójcza przeciw<br />

pchłom dla kota<br />

9497 Obroz˙a owadobójcza przeciw<br />

pchłom i kleszczom dla psa<br />

permetryna Collar for veterinary<br />

use<br />

Diazinon Collar for veterinary<br />

use<br />

Diazinon Collar for veterinary<br />

use<br />

30/11/05<br />

Wytwórnia Chemiczna PESS 31/12/08<br />

Beaphar 31/12/08<br />

Beaphar 31/12/08<br />

9498 Obstilax Tablets N.P. Pharma Sp. z o.o. 31/12/08<br />

9499 Octagam Immunoglobulinum<br />

humanum<br />

Solution for<br />

intravenous infusion<br />

10 g/200 ml Octapharma AG 31/12/08


EN<br />

1160 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9500 Octagam Immunoglobulinum<br />

humanum<br />

9501 Octagam Immunoglobulinum<br />

humanum<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

9502 Octanate 1000 Coagulation factor VIII Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

9503 Octanate 250 Coagulation factor VIII Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

9504 Octanate 500 Coagulation factor VIII Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

9505 Octanine F 1000 Coagulation factor IX Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

9506 Octanine F 500 Coagulation factor IX Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

9507 OCTAPLAS SD Blood Group<br />

A<br />

9508 OCTAPLAS SD Blood Group<br />

AB<br />

Proteini plasmatis<br />

humani<br />

Proteini plasmatis<br />

humani<br />

9509 OCTAPLAS SD Blood Group B Proteini plasmatis<br />

humani<br />

9510 OCTAPLAS SD Blood Group<br />

O<br />

Proteini plasmatis<br />

humani<br />

9511 Octreoscan Preparat<br />

radiofarmaceutyczny<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

2.5 g/50 ml Octapharma AG 31/12/08<br />

5 g/100 ml Octapharma AG 31/12/08<br />

1000 j.m. Octapharma AG 25/01/06<br />

250 j.m. Octapharma AG 25/01/06<br />

500 j.m. Octapharma AG 25/01/06<br />

1000 j.m. Octapharma AG 29/03/06<br />

500 j.m. Octapharma AG 29/03/06<br />

Octapharma Pharmazeutica<br />

Produtionges mbh<br />

Octapharma Pharmazeutica<br />

Produtionges mbh<br />

Octapharma Pharmazeutica<br />

Produtionges mbh<br />

Octapharma Pharmazeutica<br />

Produtionges mbh<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Mallinckrodt Medical B.V. 31/12/08<br />

9512 Ocuflur Flurbiprofenum Eye drops 0.03 % Pharm Allergan GmbH 31/12/06<br />

9513 Oculoheel Tablets Heel GmbH 30/06/07<br />

9514 Oculoheel Lux Eye drops Heel GmbH 30/06/07<br />

9515 Oculosan Naphazolinum + Zinci<br />

sulfas<br />

Eye drops (0,05mg +<br />

0,2mg)/ml<br />

Novartis Ophthalmics AG<br />

Hettlingen<br />

9516 Oculotect Fluid Polyvidonum Eye drops 50 mg/g Novartis Ophthalmics AG<br />

Hettlingen<br />

9517 Oculotect Fluid Sine Polyvidonum Eye drops 50 mg/g Novartis Ophthalmics AG<br />

Hettlingen<br />

30/06/04<br />

30/04/04<br />

30/04/04<br />

9518 Oculotect Gel Retinolum Eye gel 10 mg/g Novartis Ophthalmics AG 31/12/08<br />

9519 Odchudzanie Homeoporady Granules Laboratoires BOIRON 19/09/07<br />

9520 Oeanthe Crocata Complexe<br />

Nr 78<br />

9521 Oedemosan Acidum<br />

acetylsalicylicum +<br />

Fenylbutazonum<br />

9522 Oedemosan MC NF Salicylan metylu,<br />

kamfora<br />

Drops Lehning Laboratoires 31/12/08<br />

Ointment for veterinary<br />

use<br />

Ointment for veterinary<br />

use<br />

PW Vet-Agro 4/12/05<br />

Vet-Agro 31/12/08<br />

9524 Oekolp Estriolum Tablets 2 mg Dr Kade Pharmaceutical<br />

Fabrik<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1161<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9523 Oekolp Estriolum Vaginal cream 1 mg/g Dr Kade Pharmazeutische<br />

Fabrik GmbH<br />

9525 Oekolp forte Estriolum Pessary 0.5 mg Dr Kade Pharmazeutische<br />

Fabrik GmbH<br />

30/11/04<br />

29/06/05<br />

9526 Oeparol Oenotherae semen oleum Capsules 510 mg Agropharm S.A. 30/10/05<br />

9527 Oesclim Estradiolum Patch 37,5 mcg Laboratoires Fournier 31/12/08<br />

9528 Oesclim Estradiolum Patch 75,0 mcg Laboratoires Fournier 31/12/08<br />

9529 Oesclim 25 Estradiolum Transdermal patch 25 mcg/24 h Laboratoires Fournier S.A. 31/12/08<br />

9530 Oesclim 50 Estradiolum Transdermal patch 50 mcg/24 h Laboratoires Fournier S.A. 31/12/08<br />

9531 Oesclim 100 Estradiolum Transdermal patch 100 mcg/24 h Laboratoires Fournier S.A. 31/12/08<br />

9532 Oesclim 37,5 Estradiolum Transdermal patch 7.5 mg<br />

(37,5 mcg/24h)<br />

9533 Oesclim 75 Estradiolum Transdermal patch 15 mg<br />

(75 mcg/24h)<br />

Laboratoires Fournier S.A. 23/11/05<br />

Laboratoires Fournier S.A. 23/11/05<br />

9534 Oestradiolum benzoicum Estradiolum Solution for injection 2.5 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

31/01/05<br />

9535 Oestrodose Estradiolum Gel 60 mg/100 g Laboratoires Besins IscoVesco 31/12/08<br />

9536 Oestrofeminal Estrogena coniugata Capsules 0.3 mg Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

9537 Oestrofeminal Estrogena coniugata Capsules 0.6 mg Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

9538 Oestrofeminal Estrogena coniugata Capsules 1.25 mg Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

9539 Oestrogel Estradiolum Gel 60 mg/100 g<br />

z˙elu<br />

9540 Oestrophan Kloprostenol Solution for veterinary<br />

use<br />

30/11/04<br />

30/11/04<br />

30/06/04<br />

Laboratoires Besins IscoVesco 31/12/08<br />

Leciva A.S. 31/01/05<br />

9541 Oflodinex Ofloxacinum Film-coated tablets 100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

9542 Oflodinex Ofloxacinum Film-coated tablets 200 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/12/08<br />

31/12/08<br />

9543 Ofloxin 200 Ofloxacinum Film-coated tablets 200 mg Lečiva a.s. 17/01/07<br />

9544 Oframax Ceftriaxonum Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

9545 Oframax Ceftriaxonum Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

1 g Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

250 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

31/08/05<br />

31/08/05<br />

9546 Oftagel Carbomerum 974 P Eye gel 2,5 mg/g Santen OY 31/12/08<br />

9547 Oftalmolosa Cusi<br />

Chloramphenicol 1 %<br />

9548 Oftalmolosa Cusi<br />

Erythromycin 0,5 %<br />

Chloramphenicolum Eye ointment 10 mg/g Alcon Cusi, S.A. 30/06/04<br />

Erythromycinum Eye ointment 5 mg/g Alcon Cusi, S.A. 30/06/04


EN<br />

1162 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9549 Oftanex Dipivefrinum Eye drops 1 mg/ml Santen Oy 31/12/08<br />

9550 Oftanex Dipivefrinum Eye drops 1 mg/ml Santen Oy 31/12/08<br />

9551 Oftan-Timolol Timololum Eye drops 2.5 mg/ml Santen Oy 30/06/04<br />

9552 Oftan-Timolol Timololum Eye drops 5 mg/ml Santen Oy 30/06/04<br />

9553 Oftaquix Levofloxacinum Eye drops, solution 5 mg/ml Santen Oy 31/12/08<br />

9554 Oftensin Timololum Eye drops, solution 2.5 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

9555 Oftensin Timololum Eye drops, solution 5 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

9556 Oftipan Eye gel Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

9557 Oilatum Emulsion for<br />

medicinal bath<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

Stiefel Laboratories Ltd. 31/12/08<br />

9558 Oilatum Gel for medicinal bath Stiefel Laboratories Ltd. 31/08/04<br />

9559 Oilatum Plus Emulsion for<br />

medicinal bath<br />

9560 Okacin Lomefloxacinum Eye drops 0,3 % (3 mg/<br />

ml)<br />

9561 Okavax Vaccinum varicellae<br />

vivum<br />

Powder and solvent<br />

for solution for<br />

subcutaneous<br />

injection<br />

nie mniej niz˙<br />

1000 PFU<br />

z˙ywego<br />

atenuowanego<br />

wirusa ospy<br />

wietrznej<br />

(szczepionka)/<br />

dawke˛<br />

Stiefel Laboratories Ltd. 31/12/08<br />

Novartis Ophthalmics AG 31/12/08<br />

The Research Foundation for<br />

Microbial Diseases of Osaka<br />

University (BIKEN)<br />

31/12/08<br />

9562 Okovit Bional Pharma BV 31/12/08<br />

9563 Oksam Oxazepamum Tablet 10 mg GENEXO Sp.z.o.o Warszawa 31/12/08<br />

9564 Oksazepam Oxazepamum Film-coated tablets 10 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

9565 Oksytetracyklina 5 % Oxytetracyclinum Powder for veterinary<br />

use<br />

9566 Oksytetracyklina 50 % Oxytetracyclinum Powder for veterinary<br />

use<br />

9567 Oksytetracyklina 50 % Oxytetracyclinum Powder for veterinary<br />

use<br />

9568 Oksytetracykliny<br />

chlorowodorek<br />

9569 Oksytetrin LA/KS Oxytetracyclinum Solution for veterinary<br />

use<br />

30/06/07<br />

Vetos-Farma 31/12/08<br />

Vetos-Farma 25/08/05<br />

Vetos-Farma 31/12/08<br />

Scholz, Sowin 31/01/06<br />

Bimeda 31/12/08<br />

9571 Olanzapine Olanzapinum Film-coated tablets 7,5 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

9572 Olanzapine Olanzapinum Film-coated tablets 10mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

9570 Olanzapine Olanzapinum Tablets 5 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

9573 Olatrix Olanzapinum Film-coated tablets 5 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1163<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9574 Olatrix Olanzapinum Film-coated tablets 10 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

9575 Olbas Inhaler Preparat złoz˙ony Nasal stick G.R. Lane Health Products<br />

Ltd.<br />

9576 Olbas Oil Preparat złoz˙ony Inhalation vapour,<br />

solution<br />

G.R. Lane Health Products<br />

Ltd.<br />

9577 Olbas Pastilles Preparat złoz˙ony Buccal tablet G.R. Lane Health Products<br />

Ltd.<br />

9578 Olbetam Acipimoxum Capsules 250 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

31/12/08<br />

6/06/07<br />

30/04/04<br />

30/04/04<br />

30/06/04<br />

9579 Olbrot Pharma Zentrale 9/01/05<br />

9580 Olej kakaowy A.C.E.F., Włochy 31/12/08<br />

9581 Olej kakaowy BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08<br />

9582 Olej kakaowy Cefarm Cze˛stochowa 31/12/08<br />

9583 Olej kakaowy Farm-Impex s.j., Gliwice 31/12/08<br />

9584 Olej kakaowy Pharma Cosmetic, Kraków 31/12/08<br />

9585 Olej kakaowy Pharma Zentrale 31/12/08<br />

9586 Olej kakaowy PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

9587 Olej kakaowy Ziaja, Gdańsk 31/12/08<br />

9588 Olej kakowy Cefarm Wrocław 31/07/05<br />

9589 Olej kamforowy Aflofarm Farmacja Polska,<br />

Pabianice<br />

10/06/06<br />

9590 Olej kamforowy AUGMED, Dawidy Bankowe 10/06/06<br />

9591 Olej kamforowy Avena, Bydgoszcz 10/06/06<br />

9592 Olej kamforowy Cefarm Gdańsk 10/06/06<br />

9593 Olej kamforowy Farmina Sp. z o.o., Kraków 10/06/06<br />

9594 Olej kamforowy Felix-Pharma, Lublin 10/06/06<br />

9595 Olej kamforowy GAL, Poznań 10/06/06<br />

9596 Olej kamforowy Galenus, Rzeszów 10/06/06<br />

9597 Olej kamforowy Hasco-Lek, Wrocław 10/06/06<br />

9598 Olej kamforowy Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

10/06/06<br />

9599 Olej kamforowy Lefarm, Bydgoszcz 10/06/06<br />

9600 Olej kamforowy PPF GEMI, Karczew 10/06/06<br />

9601 Olej kamforowy PZF ‘Cefarm-Lublin’ S.A. 10/06/06<br />

9602 Olej kamforowy Semifarm, Gdańsk 10/06/06<br />

9603 Olej kamforowy Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

10/06/06


EN<br />

1164 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9604 Olej kmforowy Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

9605 Olej lniany Lini oleum AGROPHARM, Tuszyn k/<br />

Łodzi<br />

24/01/06<br />

30/09/05<br />

9606 Olej lniany Lini oleum GAL, Poznań 30/09/05<br />

9607 Olej lniany Lini oleum Instytut Włókien<br />

Naturalnych, Poznań<br />

30/09/05<br />

9608 Olej lniany Lini oleum Pharma Cosmetic, Kraków 30/09/05<br />

9609 Olej lniany Lini oleum Pharma Zentrale 30/09/05<br />

9610 Olej lniany Lini oleum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

9611 Olej Parafinowy Parafina ciekła Liquid for veterinary<br />

use<br />

30/09/05<br />

PFO Vetos-Farma 16/04/07<br />

9612 Olej rycynowy Oleum ricini Aflofarm Farmacja Polska,<br />

Pabianice<br />

30/11/05<br />

9613 Olej rycynowy Oleum ricini Elissa, Warszawa 30/11/05<br />

9614 Olej rycynowy Oleum ricini Farmina Sp. z o.o., Kraków 30/11/05<br />

9615 Olej rycynowy Oleum ricini Felix Pharma, Lublin 30/11/05<br />

9616 Olej rycynowy Oleum ricini GAL, Poznań 30/11/05<br />

9617 Olej rycynowy Oleum ricini Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

9618 Olej rycynowy Oleum ricini Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

9619 Olej rycynowy Oleum ricini Medana Pharma Terpol<br />

Group, Sieradz<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

9620 Olej rycynowy Oleum ricini Pharma Cosmetic, Kraków 30/11/05<br />

9621 Olej rycynowy Oleum ricini Pharma Zentrale 30/11/05<br />

9622 Olej rycynowy Oleum ricini Phytopharm Kle˛ka S.A. 30/11/05<br />

9623 Olej rycynowy Oleum ricini PPF GEMI, Karczew 30/11/05<br />

9624 Olej rycynowy Oleum ricini PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

30/11/05<br />

9625 Olej rycynowy Oleum ricini Prolab, Paterek k/Nakła 30/11/05<br />

9626 Olej rycynowy Oleum ricini Semifarm, Gdańsk 30/11/05<br />

9627 Olej rzepakowy Rapae oleum GAL, Poznań 22/06/05<br />

9628 Olej rzepakowy Rapae oleum Pharma Cosmetic, Kraków 22/06/05<br />

9629 Olej rzepakowy Rapae oleum Pharma Zentrale 22/06/05<br />

9630 Olej rzepakowy Rapae oleum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

22/06/05<br />

9631 Olej z malwy Oil WALA-Heilmittel GmbH 24/05/07<br />

9632 Olej z melisy Oil for rub (Rub oil) WALA-Heilmittel GmbH 24/05/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1165<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9633 Olej z nasion wiesiołka Capsules Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

9634 Olej z Nasion Wiesiołka<br />

Dwuletniego<br />

Oenotherae semen<br />

oleum+ Tocopherolum<br />

30/10/05<br />

Capsules 500mg + 5mg Vitamex AB 30/04/04<br />

9635 Olejek anyz˙owy AVICENNA OIL, Wrocław 31/12/05<br />

9636 Olejek anyz˙owy Caesar & Loretz GmbH Caelo 31/12/05<br />

9637 Olejek anyz˙owy Pharma Zentrale 31/12/05<br />

9638 Olejek eukaliptusowy Eucalypti aetheroleum Apotheca Pacis, Rybnik 31/07/05<br />

9639 Olejek eukaliptusowy Eucalypti aetheroleum AVICENNA OIL, Wrocław 31/07/05<br />

9640 Olejek eukaliptusowy Eucalypti aetheroleum Caesar & Loretz GmbH Caelo 31/07/05<br />

9641 Olejek eukaliptusowy Eucalypti aetheroleum Dullberg Konzentra 31/07/05<br />

9642 Olejek eukaliptusowy Eucalypti aetheroleum Pharma Cosmetic, Kraków 31/07/05<br />

9643 Olejek eukaliptusowy Eucalypti aetheroleum Pharma Zentrale 31/07/05<br />

9644 Olejek eukaliptusowy Eucalypti aetheroleum PPHU KEJ s.c., Wieliczka 31/07/05<br />

9645 Olejek kopru włoskiego Caesar & Loretz GmbH Caelo 31/12/08<br />

9646 Olejek kopru włoskiego Pharma Zentrale 31/12/08<br />

9647 Olejek lawendowy AVICENNA OIL, Wrocław 31/12/05<br />

9648 Olejek lawendowy Pharma Cosmetic, Kraków 31/12/05<br />

9649 Olejek lawendowy Pharma Zentrale 31/12/05<br />

9650 Olejek mie˛ty pieprzowej Menthae piperitae<br />

aetheroleum<br />

9651 Olejek mie˛ty pieprzowej Menthae piperitae<br />

aetheroleum<br />

9652 Olejek mie˛ty pieprzowej Menthae piperitae<br />

aetheroleum<br />

9653 Olejek mie˛ty pieprzowej Menthae piperitae<br />

aetheroleum<br />

9654 Olejek mie˛ty pieprzowej Menthae piperitae<br />

aetheroleum<br />

9655 Olejek mie˛ty pieprzowej Menthae piperitae<br />

aetheroleum<br />

Apotheca Pacis, Rybnik 31/07/05<br />

Caesar & Loretz GmbH Caelo 31/07/05<br />

Dullberg Konzentra 31/07/05<br />

Pharma Cosmetic, Kraków 31/07/05<br />

Pharma Zentrale 31/07/05<br />

PPHU KEJ s.c., Wieliczka 31/07/05<br />

9656 Olejek sosnowy Pini silvestris oleum Apotheca Pacis, Rybnik 31/07/05<br />

9657 Olejek sosnowy Pini silvestris oleum AVICENNA OIL, Wrocław 31/07/05<br />

9658 Olejek sosnowy Pini silvestris oleum Dullberg Konzentra 31/07/05<br />

9659 Olejek sosnowy Pini silvestris oleum Pharma Cosmetic, Kraków 31/07/05<br />

9660 Olejek sosnowy Pini silvestris oleum Pharma Zentrale 31/07/05<br />

9661 Olejek sosnowy Pini silvestris oleum PPHU KEJ s.c., Wieliczka 31/07/05<br />

9662 Olejek terpentynowy Elissa, Warszawa 19/06/06<br />

9663 Olejek terpentynowy Pharma Cosmetic, Kraków 19/06/06<br />

9664 Olejek terpentynowy Pharma Zentrale 19/06/06


EN<br />

1166 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9665 Olejek terpentynowy PPF GEMI, Karczew 19/06/06<br />

9666 Olejek terpentynowy Prolab, Paterek k/Nakła 19/06/06<br />

9667 Olejek tymiankowy AVICENNA OIL, Wrocław 31/12/05<br />

9668 Olejek tymiankowy Pharma Zentrale 31/12/05<br />

9669 Olfen Diclofenacum Gel 10 mg/g Mepha Ltd. 30/06/04<br />

9670 Olfen 25 Diclofenacum Film-coated tablets 25 mg Mepha Ltd. 30/06/04<br />

9672 Olfen 50 Diclofenacum Film-coated tablets 50 mg Mepha Ltd. 30/06/04<br />

9671 Olfen 50 Diclofenacum Rectal capsules 50 mg Mepha Ltd. 30/04/04<br />

9673 Olfen 75 Diclofenacum +<br />

Lidocainum<br />

Solution for injection 37.5 mg/ml Mepha Ltd. 30/06/04<br />

9674 Olfen 100 Diclofenacum Rectal capsules 100 mg Mepha Ltd. 30/04/04<br />

9675 Olfen 100 SR Diclofenacum Prolonged release<br />

capsules<br />

9676 Olfen 75 Sr Diclofenacum Film-coated,<br />

prolonged release<br />

tablets<br />

9677 Olicard 40 retard Isosorbidi mononitras Prolonged release<br />

capsules<br />

9678 Olicard 60 retard Isosorbidi mononitras Prolonged release<br />

capsules<br />

9679 Olicard retard 40 Isosorbidi mononitras Prolonged release<br />

capsules<br />

9680 Olicard retard 60 Isosorbidi mononitras Prolonged release<br />

capsules<br />

9681 Olopeg Macrogolum Concentrate for oral<br />

solution<br />

9682 Olvac A+B Inaktywowana<br />

szczepionka przeciw<br />

rzekomemu pomorowi<br />

drobiu, syndromowi<br />

spadku nies´nos´ci i<br />

zakaz´nemu zapaleniu<br />

oskrzeli dla kur<br />

9683 Olvac A+B+G Szczepionka dla kur<br />

przeciwko rzekomemu<br />

pomorowi drobiu<br />

zakaz´nemu zapaleniu<br />

oskrzeli, syndromowi<br />

spadku nios´nos´ci i<br />

zapaleniu torby<br />

Fabrycjusza<br />

100 mg Mepha Ltd. 30/06/04<br />

75 mg Mepha Pharma AG 30/09/07<br />

40 mg Solvay Pharmaceuticals<br />

GmbH<br />

60 mg Solvay Pharmaceuticals<br />

GmbH<br />

31/07/04<br />

31/07/04<br />

40 mg Glaxo Wellcome S.A. 31/12/08<br />

60 mg Glaxo Wellcome S.A. 31/12/08<br />

13,125 g/<br />

25 ml<br />

Oil emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

MIP Pharma Polska Sp. z o.o. 31/12/08<br />

FATRO 28/12/04<br />

Fatro Włochy 31/12/08<br />

9684 Olzapin Olanzapinum Film-coated tablet 5mg i 10 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

31/12/08<br />

9685 Om 24 Omeprazolum Capsules, hard 10 mg US Pharmacia 31/12/08<br />

9686 Omar Omeprazolum Gastro-resistant<br />

capsules, hard<br />

20 mg Hexal AG 5/07/06<br />

9687 Omega — 3 Olej rybi Capsule, soft 1000 mg PRO NATURA s.j. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1167<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9688 Omega — 3 Alfa Glucasamine<br />

+ Chondroitin<br />

Olej rybi (kapsułki)<br />

Glukosominum sulfas +<br />

Chondroitini sulfas +<br />

Vit. C (tabletki)<br />

Capsules, tablets 1000 mg;<br />

(500 mg +<br />

200 mg +<br />

63,2 mg)<br />

Lysi Ltd. 31/12/08<br />

9689 OMEGA + D And Calcium Preparat złoz˙ony Capsules + tablets Lysi Ltd. 31/12/08<br />

9690 Omega-3 Omega-3-trójglicerydy Capsules, soft 1000 mg Lysi HF 23/11/05<br />

9691 Omegast Omeprazolum Capsules 20 mg Polfarmex Sp. z o.o. 31/12/08<br />

9692 Omegaven Emulsion for infusion Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

9693 Omeprazole Omeprazolum Capsules 20 mg Stirolpharm Company of S.C.<br />

Concern Stirol<br />

23/11/05<br />

31/12/08<br />

9694 Omeprazol-Egis Omeprazolum Capsules 20 mg Egis Pharmaceuticals Ltd. 17/01/07<br />

9695 Omeral Omeprazolum Capsules 10 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

9696 Omeral Omeprazolum Capsules 20 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

9697 Omnadren 250 Testosteronum Solution for injection Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

9698 Omnic 0,4 Tamsulosinum Prolonged release<br />

capsules<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

0.4 mg Yamanouchi Europe B.V. 30/06/07<br />

9699 Omnipaque Iohexolum Solution for injection 302 mg/ml Nycomed Imaging AS 31/07/04<br />

9700 Omnipaque Iohexolum Solution for injection 388 mg/ml Nycomed Imaging AS 31/07/04<br />

9701 Omnipaque Iohexolum Solution for injection 518 mg/ml Nycomed Imaging AS 31/07/04<br />

9702 Omnipaque Iohexolum Solution for injection 647 mg/ml Nycomed Imaging AS 31/07/04<br />

9703 Omnipaque Iohexolum Solution for injection 755 mg/ml Nycomed Imaging AS 31/07/04<br />

9704 Omniscan Gadodiamidum Solution for<br />

intravenous injection<br />

9705 Omnygram Ampicillinum +<br />

Cloxacillnum<br />

Suspension for veterinary<br />

use<br />

9706 Oncaspar Pegasparagasum Solution for<br />

intramuscular,<br />

intravenous injection<br />

and intravenous<br />

infusion<br />

9707 OncoTICE Tuberculinum Powder for<br />

suspension for<br />

intravesical use<br />

9708 Ondansetron Ondansetronum Solution for<br />

intramuscular,<br />

intravascular injection<br />

and for intravenous<br />

infusion<br />

9709 Onko BCG Tuberculinum Intrabladder<br />

suspension<br />

9710 Onko BCG 100 Tuberculinum powder and solvent<br />

for suspension for<br />

intrabladder use<br />

0.5 mmol J/ml Nycomed AS 20/10/05<br />

Virbac S.A. 4/12/05<br />

750 j.m./ml medac Gesellschaft fur<br />

Klinische Spezialpraparate<br />

mbH<br />

27/06/07<br />

500 mln CFU Organon N.V. 3/06/06<br />

2 mg/ml PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

100 mg/ml<br />

pra˛tków<br />

100 mg<br />

pra˛tków BCG<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

31/12/08<br />

31/05/06<br />

28/02/06


EN<br />

1168 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9711 Onko BCG 50 Tuberculinum powder and solvent<br />

for suspension for<br />

intrabladder use<br />

50 mg pra˛tków<br />

BCG<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

9712 Opacorden Amiodaronum Film-coated tablets 200 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

9713 Oparzenia słoneczne<br />

HomeoPorady<br />

28/02/06<br />

30/10/05<br />

Laboratoires BOIRON 4/07/07<br />

9714 Ophticor H Hydrocortisonum Eye drops, suspension 10 mg/ml Continental Pharma Inc 30/11/04<br />

9715 Opryszczka HomeoPorady Laboratoires BOIRON 30/06/07<br />

9716 Optibetol 0,5 % Betaxololum Eye drops, solution 5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

9717 Opticortenol S Trójmetylooctan<br />

deksametazonu,<br />

Prednizolon<br />

Suspension for veterinary<br />

use<br />

14/02/07<br />

Novartis Animal Health Inc. 11/03/04<br />

9718 Opticrom Acidum cromoglicicum Eye drops, solution 20 mg/ml Rhône-Poulenc Rorer Fisons<br />

Ltd.<br />

9719 Optiderm Carbamidum +<br />

Polidocanolum<br />

9720 Optiderm F Carbamidum +<br />

Polidocanolum<br />

Cream Boots Healthcare<br />

International<br />

Cream Boots Healthcare<br />

International<br />

9721 Optimark Gadoversetamidum Solution for injection 0,5 mmol/ml MALLINCKRODT MEDICAL<br />

GmbH<br />

9722 Optimmune Ciclosporinum Eye ointment for veterinary<br />

use<br />

Schering-Plough Central East<br />

Ag<br />

9723 Optiray 240 Ioversolum Solution for injection 240 mg/ml MALLINCKRODT MEDICAL<br />

GmbH<br />

9724 Optiray 300 Ioversolum Solution for injection 300 mg/ml MALLINCKRODT MEDICAL<br />

GmbH<br />

9725 Optiray 320 Ioversolum Solution for injection 320 mg/ml MALLINCKRODT MEDICAL<br />

GmbH<br />

9726 Optiray 350 Ioversolum Solution for injection 350 mg/ml MALLINCKRODT MEDICAL<br />

GmbH<br />

9727 Optison Mikrosfery albuminy<br />

ludzkiej zawieraja˛ce<br />

oktafluoropropan<br />

9728 Optivermin Prazikwantel,<br />

fenbendazol<br />

Suspension for<br />

injection<br />

Tablets for veterinary<br />

use<br />

MALLINCKRODT MEDICAL<br />

GmbH<br />

16/06/05<br />

31/12/08<br />

16/05/07<br />

31/12/08<br />

7/02/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Biowet Gorzów 31/12/08<br />

9729 Oracef Cefalexinum Capsules 500 mg Krka d.d., Novo mesto 30/04/04<br />

9730 Orajel Maximum Strength Benzocainum Oromucosal gel 200 mg/g Del Pharmaceuticals INC 16/05/07<br />

9731 Orajel Mouth Aid Gel Benzocainum Oromucosal gel 200 mg/g Del Pharmaceuticals INC 30/04/04<br />

9732 Orajel Regular Strength Gel Benzocainum Oromucosal gel 100 mg/g Del Pharmaceuticals INC 30/04/04<br />

9733 Orange-vit Syrup Nycomed AS 31/07/04<br />

9734 Oratest Solution 1 % DDD/Fleet Laboratories 31/12/08<br />

9735 Orbax 25 mg Orbifloksacyna Tablets for veterinary<br />

use<br />

9736 Orbax 6,25 mg Orbifloksacyna Tablets for veterinary<br />

use<br />

Schering Plough 31/12/08<br />

Schering Plough 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1169<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9737 Orbax 75 mg orbifloksacyna Tablets for veterinary<br />

use<br />

9738 Orbenin D.C. Cloxacillinum Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

9739 Orbenin EDC Cloxacillinum Suspension for veterinary<br />

use<br />

Schering Plough 31/12/08<br />

Pfizer Italia S.r.I. 20/08/04<br />

Pfizer Italia S.r.I 8/12/07<br />

9740 Orelox Cefpodoximum Film-coated tablets 0.1 g Laboratories Diamant Roussel<br />

Uclaf<br />

30/04/04<br />

9742 Orfiril Acidum valproicum Oral solution 300 mg/ 5 ml Desitin Arznemittel GmbH 30/06/04<br />

9741 Orfiril Acidum valproicum Solution for<br />

intravenous injection<br />

9743 Orfiril 150 Acidum valproicum Gastro-resistant<br />

tablets<br />

9744 Orfiril 300 Acidum valproicum Gastro-resistant<br />

tablets<br />

9745 Orfiril 300 retard Acidum valproicum Gastro-resistant,<br />

prolonged release<br />

tablets<br />

9746 Orfiril 600 Acidum valproicum Gastro-resistant<br />

tablets<br />

9747 Orfiril Long Natrii valproas Prolonged release<br />

capsules<br />

9748 Orfiril Long Natrii valproas Prolonged release<br />

capsules<br />

9749 Orfiril Long 1000 Natrii valproas Prolonged release<br />

minitablets<br />

9750 Orfiril Long 500 Natrii valproas Prolonged release<br />

minitablets<br />

9751 Orgalutran Octan ganirelixu Solution for injection 0.25 mg/<br />

0,5ml<br />

100 mg/ml Desitin Arznemittel GmbH 30/09/04<br />

150 mg Desitin Arznemittel GmbH 30/06/04<br />

300 mg Desitin Arznemittel GmbH 30/06/04<br />

300 mg Desitin Arznemittel GmbH 30/06/04<br />

600 mg Desitin Arznemittel GmbH 30/06/04<br />

150 mg Desitin Arzneimittel GmbH 31/12/08<br />

300 mg Desitin Arzneimittel GmbH 31/12/08<br />

500 mg Desitin Arzneimittel GmbH 31/12/08<br />

500 mg Desitin Arzneimittel GmbH 31/12/08<br />

Organon N.V. 10/05/06<br />

9752 Orgametril Lynestrenolum Tablets 5 mg Organon N.V. 30/04/05<br />

9753 ORGANUM QUADRU-PLEX<br />

amp.<br />

9754 ORGANUM QUADRU-PLEX<br />

gran.<br />

9755 Oridermyl Neomycyny siarczan,<br />

Nystatyna,<br />

Triamcinolonu<br />

acetonid, Lindan,<br />

Lidokaina<br />

Ointment for veterinary<br />

use<br />

9756 Ornicure Doxycyclinum Powder for veterinary<br />

use<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

Vetoquinol S.A. 19/12/06<br />

Laboratoria Smeets BVBA 6/06/05<br />

9757 Oroclean Ear wash, emulsion Inter Proma AG 5/07/06<br />

9760 Orofar Benzoxonii chloridum +<br />

Lignocainum chloratum<br />

9759 Orofar Benzoxonii chloridum +<br />

Lignocainum chloratum<br />

9758 Orofar Benzoxonii chloridum +<br />

Lignocainum chloratum<br />

Buccal tablet 1mg + 1mg Novartis Consumer Health<br />

S.A.<br />

Oromucosal solution (0,5mg +<br />

0,5mg)/ml<br />

Oromucosal spray (2mg +<br />

1,5mg)/ml<br />

Novartis Consumer Health<br />

S.A.<br />

Novartis Consumer Health<br />

S.A.<br />

21/03/07<br />

21/03/07<br />

21/03/07


EN<br />

1170 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9761 Oropivalone Bacitracine Tixocortoloni pivalas +<br />

Neomycinum<br />

Buccal tablets Jouveinal Laboratories 31/12/08<br />

9762 Oros Pe-240 Pseudoephedrinum Tablets 240 mg Pfizer European Service 31/12/08<br />

9763 Ortanol Omeprazolum Capsuels, hard 20 mg Lek Pharmaceuticals d.d. 30/06/04<br />

9764 Ortanol Omeprazolum Capsuels, hard 20 mg Lek Polska Sp. z o.o. 31/12/05<br />

9765 Ortanol Omeprazolum Film-coated tablets 20 mg Lek Pharmaceuticals d.d. 31/12/07<br />

9766 Ortanol Omeprazolum Film-coated tablets 20 mg Lek Polska Sp. z o.o. 31/12/07<br />

9767 Orthoclone OKT3 Muromonabum-CD3 Solution for injection 1 mg/ml Ortho BIOTECH Inc. 31/07/04<br />

9768 Orthocor Plus Preparat złoz˙ony Granules + capsules<br />

— set<br />

Orthomal Pharmaceutical<br />

Markieting Ltd.<br />

31/12/08<br />

9769 Ortho-Gynest Estriolum Vaginal cream 0.1 mg/g Cilag AG 30/01/05<br />

9770 Ortho-Gynest D Estriolum Pessary 3.5 mg Cilag AG 30/06/04<br />

9771 Orthoimmun Preparat złoz˙ony Granules Orthomal Pharmaceutical<br />

Markieting Ltd.<br />

9772 Orthoimmun Preparat złoz˙ony Tablets and capsuls Orthomal Pharmaceutical<br />

Markieting Ltd.<br />

9773 Ortofosforan sodu Na 2H 32PO 4<br />

do wstrzykiwań<br />

Preparat<br />

radiodiagnostyczny<br />

Solution for injection Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

9774 Orungal Itraconazolum Capsules 100 mg Janssen Pharmaceutica N.V. 31/03/04<br />

9775 Orungal Itraconazolum Concantrate for<br />

solution for infusion<br />

10 mg/ml Janssen Pharmaceutica 31/03/04<br />

9776 Orungal Itraconazolum Oral solution 10 mg/ml Janssen Pharmaceutica N.V. 31/03/04<br />

9777 Orvac Doustna szczepionka<br />

przeciw róz˙ycy s´wiń<br />

Lyophilisate + solvent for veterinary<br />

use<br />

9778 Osalen Acidum alendronicum Tablets 10 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Biowet Puławy 31/12/08<br />

31/05/05<br />

9779 Oscillococcinum Granules Laboratoires BOIRON 31/12/07<br />

9780 Osmolite Preparat odz˙ywczy Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

14/03/06<br />

9784 Ospamox Amoxicillinum Film-coated tablets 1 g Biochemie GmbH — Kundl 30/09/04<br />

9785 Ospamox Amoxicillinum Film-coated tablets 500 mg Biochemie GmbH — Kundl 30/09/04<br />

9786 Ospamox Amoxicillinum Film-coated tablets 750 mg Biochemie GmbH — Kundl 30/09/04<br />

9781 Ospamox Amoxicillinum Granules for oral<br />

suspension<br />

9782 Ospamox Amoxicillinum Granules for oral<br />

suspension<br />

9783 Ospamox Amoxicillinum Granules for oral<br />

suspension<br />

125 mg/5ml Biochemie GmbH — Kundl 30/09/04<br />

250 mg/5ml Biochemie GmbH — Kundl 30/09/04<br />

375 mg/5ml Biochemie GmbH — Kundl 30/09/04<br />

9787 Ospamox 250 Amoxicillinum Capsules 250 mg Biochemie GmbH — Kundl 31/12/08<br />

9788 Ospen Phenoxymethylpenicillinum<br />

Film-coated tablets 1500000 j.m. Biochemie GmbH — Kundl 30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1171<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9789 Ospen Phenoxymethylpenicillinum<br />

9790 Ospen Phenoxymethylpenicillinum<br />

9791 Ospen 400 Benzathini phenoxymethylpenicillinum<br />

9792 Ospen 750 Benzathini phenoxymethylpenicillinum<br />

9793 OSSIPLEX Retard Natrium fluoratum,<br />

Acidum ascorbicum<br />

Film-coated tablets 1000000 j.m. Biochemie GmbH — Kundl 30/04/04<br />

Film-coated tablets 500000 j.m. Biochemie GmbH — Kundl 30/04/04<br />

Oral suspension 400000 j.m./<br />

5ml<br />

Suspension 750000 j.m./<br />

5ml<br />

Film-coated,<br />

prolonged release<br />

tablets<br />

Biochemie GmbH — Kundl 31/10/04<br />

Biochemie GmbH — Kundl 30/06/05<br />

P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

9794 Ossopan Film-coated tablets Robapharm AG 31/05/05<br />

9795 Ost 70 Acidum alendronicum Tablets 70 mg Kutnowskie Zakłady<br />

Farmaceutyczne Polfa Kutno<br />

S.A.<br />

31/12/08<br />

9796 Ostedron Dinatrii etidronas Tablets 400 mg ICN Polfa Rzeszów S.A. 30/06/05<br />

9797 Ostedron Pag Dinatrii etidronas Tablets 200 mg ICN Polfa Rzeszów S.A. 30/06/05<br />

9798 Ostelavit Colecalciferolum Tablets 25 mcg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

9799 Ostemax Acidum alendronicum Tablets 5 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

9800 Ostemax Acidum alendronicum Tablets 10 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

9801 Ostemax Acidum alendronicum Tablets 70 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

9802 Ostenil Acidum alendronicum Tablets 10 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

9803 Osteo — Calperos D3 Calcii carbonas +<br />

Vitaminum D3<br />

9804 Osteo — Calperos D3 Calcii carbonas +<br />

Vitaminum D3<br />

Lozenge 500 mg +<br />

400 iu<br />

Tablets 500 mg +<br />

400 iu<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/05/04<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/06/05<br />

31/12/08<br />

31/12/08<br />

9805 Osteocynesine Tablets Laboratoires BOIRON 31/12/07<br />

9806 Osteogel (Preparat wapniowomagnezowy)<br />

Oral suspension Pampa — Laboratorium<br />

Farmaceutyczno-Kosmetyczne<br />

31/12/08<br />

9807 Osteogenon Film-coated tablets Robapharm AG 31/05/05<br />

9808 Osteoheel S Tablets Heel GmbH 31/12/08<br />

9809 Osteotropin Calcitoninum salmonis Nasal spray 200 j.m. Bioton Sp. z o.o. 31/12/08<br />

9810 Ostical Calcii carbonas + Calcii<br />

lactas gluconas<br />

Powder for oral<br />

solution<br />

500 mg Ca++ GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

9811 Ostical® Complex Preparat złoz˙ony Buccal tablets GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

9812 Ostical®D Calcii carbonas,<br />

Colecalciferolum<br />

9813 Ostifem Ipriflavonum + Calcium<br />

+ Vit. D3<br />

Effervescent tablets 400 mg Ca2+<br />

+ 200 j.m.<br />

Film-coated tablets 150 mg +<br />

125 mg +<br />

150 j.m.<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

28/02/06<br />

31/12/08<br />

31/12/08<br />

P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08


EN<br />

1172 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9814 Ostinor Risedronatum Film-coated tablets 5 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

9815 Ostinor Risedronatum Film-coated tablets 35 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

9816 Ostolek Acidum alendronicum Film-coated tablets 10 mg Lek-AM Sp. z o.o.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

9817 Ostolek Acidum alendronicum Tablets 70 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

31/12/08<br />

31/12/08<br />

27/06/07<br />

31/12/08<br />

9818 Ostostabil 100 Calcitoninum salmonis Solution for injection 100 j.m./ml Jenapharm GmbH & Co. 31/07/04<br />

9819 Ostowap D3 Calcii carbonas,<br />

Colecalciferolum<br />

9820 Ostowap D3 Calcii carbonas,<br />

Colecalciferolum<br />

Film-coated tablets 250 mg, +<br />

200 j.m.<br />

Film-coated tablets 500 mg, +<br />

400 j.m.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

9821 Ostowap D3 Plus Preparat złoz˙ony Buccal tablets Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

9822 Ostram Calcii phosphas Powder for<br />

suspension<br />

9823 Ostram Calcii phosphas Powder for<br />

suspension<br />

9824 Oterna Betametazon,<br />

Neomycyny siarczan,<br />

Monosulfiram<br />

Ear drops for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

1200 mg Ca++ Lipha Sante 31/07/04<br />

600 mg Ca++ Lipha Sante 31/07/04<br />

Schering-Plough Central East 11/08/04<br />

9825 Otinum Cholini salicylas Ear drops 0.2 g/g ICN Polfa Rzeszów S.A. 31/12/05<br />

9826 Otisan Gentamicinum +<br />

Miconazolum +<br />

Prednioslonum<br />

9827 Otomax Gentamycyny siarczan,<br />

Betametazonu<br />

walerianian,<br />

Klotrimazol<br />

Solution for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Vet-Agro 31/12/08<br />

Schering-Plough Central East<br />

Ag<br />

5/01/06<br />

9828 Ototalgin Cholini salicylas Ear drops Farmina Sp. z o.o. 31/12/08<br />

9829 Otrex 600 Diosminum Tablets 600 mg Stragen Pharma SA 13/05/07<br />

9830 Otre˛buski Otre˛by pszenne<br />

preparowane<br />

Film-coated tablets Sanofi-Synthelabo Sp. z o.o. 22/09/05<br />

9832 Otrivin 0,05 % Xylometazolinum Nasal drops, solution 0.5 mg/ml Novartis Consumer Health<br />

S.A.<br />

9831 Otrivin 0,05 % Xylometazolinum Nasal spray, solution 0.5 mg/ml Novartis Consumer Health<br />

S.A.<br />

9834 Otrivin 0,1 % Xylometazolinum Nasal drops, solution 1 mg/ml Novartis Consumer Health<br />

S.A.<br />

9833 Otrivin 0,1 % Xylometazolinum Nasal spray, solution 1 mg/ml Novartis Consumer Health<br />

S.A.<br />

9835 Ovagen FSH hormon Lyophilisate for veterinary<br />

use<br />

6/06/07<br />

6/06/07<br />

6/06/07<br />

6/06/07<br />

Immuno-Chemical Products 18/08/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1173<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9836 Ovaren Kloprostenol Solution for veterinary<br />

use<br />

CP-Pharma 31/12/08<br />

9837 OVARIA comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

9838 OVARIA comp. gran. WALA-Heilmittel GmbH 19/03/05<br />

9839 Ovarium compositum Amp. Heel GmbH 31/12/07<br />

9840 Ovestin Estriolum Pessary 0.5 mg Organon N.V. 30/04/04<br />

9842 Ovestin Estriolum Tablets 2 mg Organon N.V. 30/04/04<br />

9841 Ovestin Estriolum Vaginal cream 1 mg/g Organon Irlandia Ltd 30/04/04<br />

9843 Ovidrel Choriogonadotropinum<br />

alfa<br />

9844 OVO — 4 Szczepionka przeciw<br />

zakz´nemu zapaleniu<br />

oskrzeli, rzekomemu<br />

pomorowi drobiu,<br />

syndromowi spadku<br />

nies´nos´ci, syndromowi<br />

wielkiej głowy dla kur<br />

Powder and solvent<br />

for solution for<br />

subcutaneous<br />

injection<br />

Emulsion for veterinary<br />

use<br />

250 mcg Serono Europe Limited 31/12/08<br />

Merial 10/05/04<br />

9846 Owoc anyz˙u Anisi fructus Bags 2 g Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14/03/07<br />

9847 Owoc anyz˙u Anisi fructus Herbalux, Warszawa 14/03/07<br />

9848 Owoc anyz˙u Anisi fructus Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

9849 Owoc anyz˙u Anisi fructus Zioła Lecznicze Boguccy,<br />

Kraków<br />

9850 Owoc anyz˙u 1 i 2 Anisi fructus Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

9851 Owoc anyz˙u 1 i 2 (Anyz˙ fix,<br />

Anisi fix)<br />

14/03/07<br />

14/03/07<br />

31/12/08<br />

Anisi fructus Herbapol Lublin 2/11/07<br />

9852 Owoc anyz˙u 2 Anisi fructus Phytopharm Dobrzyca 19/11/06<br />

9853 Owoc borówki czernicy Fructus myrtilli Herbalux, Warszawa 26/03/06<br />

9854 Owoc borówki czernicy Fructus myrtilli Herbapol Lublin 26/03/06<br />

9855 Owoc borówki czernicy Fructus myrtilli Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

9856 Owoc borówki czernicy Fructus myrtilli Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

26/03/06<br />

26/03/06<br />

9857 Owoc borówki czernicy 1 Fructus myrtilli Herbapol Kraków 31/10/05<br />

9858 Owoc borówki czernicy 1 Fructus myrtilli Zioła Lecznicze Boguccy,<br />

Kraków<br />

9859 Owoc borówki czernicy 2 Fructus myrtilli Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/10/05<br />

30/06/06<br />

9860 Owoc bzu czarnego Herbapol Kraków 31/08/05<br />

9861 Owoc bzu czarnego Herbapol Lublin 31/08/05<br />

9862 Owoc bzu czarnego Herbapol Pruszków 31/08/05


EN<br />

1174 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9863 Owoc bzu czarnego Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

9864 Owoc bzu czarnego Zioła Lecznicze Boguccy,<br />

Kraków<br />

31/08/05<br />

31/08/05<br />

9865 Owoc bzu czarnego (1 i 2) Herbalux, Warszawa 31/12/08<br />

9866 Owoc bzu czarnego 1 i 2 Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

9867 Owoc dzikiej róz˙y (1 i 2) Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

31/12/08<br />

31/12/05<br />

9869 Owoc głogu Crataegi fructus Herb Elanda S.C. 29/09/07<br />

9868 Owoc głogu Crataegi fructus Herb in bags Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

29/09/07<br />

9870 Owoc głogu Crataegi fructus Herbalux, Warszawa 29/09/07<br />

9871 Owoc głogu Crataegi fructus Herbapol Kraków 29/09/07<br />

9872 Owoc głogu Herb Bogucki, Kraków 29/09/07<br />

9873 Owoc głogu Herb Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’<br />

9874 Owoc Głogu Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

29/09/07<br />

29/09/07<br />

9875 Owoc Głogu Herb Herbapol Lublin S.A. 29/09/07<br />

9876 Owoc Głogu Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

29/09/07<br />

9877 Owoc jałowca Herbapol Lublin 31/12/07<br />

9878 Owoc jałowca Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

9879 Owoc jałowca Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/12/07<br />

31/12/07<br />

9880 Owoc jałowca 1 Herbapol Kraków 31/08/05<br />

9881 Owoc Jałowca -Fructus<br />

Juniperi<br />

Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

31/12/04<br />

9882 Owoc keli Herbalux, Warszawa 31/12/08<br />

9883 Owoc kminku Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

9884 Owoc kminku Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

9885 Owoc kminku Zioła Lecznicze Boguccy,<br />

Kraków<br />

18/12/05<br />

18/12/05<br />

18/12/05<br />

9886 Owoc kminku (1 i 2) Herbalux, Warszawa 31/12/08<br />

9887 Owoc kminku 1 Herbapol Kraków 31/08/05<br />

9888 Owoc kolendry Herbalux, Warszawa 28/02/06<br />

9889 Owoc kolendry Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

9890 Owoc kolendry Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

28/02/06<br />

28/02/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1175<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9891 Owoc kolendry Zioła Lecznicze-Boguccy,<br />

Kraków<br />

28/02/06<br />

9892 Owoc kopru 2 Phytopharm Dobrzyca 19/11/06<br />

9893 Owoc kopru włoskiego Elanda, Rozprza 31/08/05<br />

9894 Owoc kopru włoskiego Herbapol Pruszków 31/08/05<br />

9895 Owoc kopru włoskiego Herbapol Wrocław 31/08/05<br />

9896 Owoc kopru włoskiego Jukunda Naturarzneimittel 31/08/05<br />

9897 Owoc kopru włoskiego Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

9898 Owoc kopru włoskiego Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

9899 Owoc kopru włoskiego Capsules 400 mg Aflofarm Fabryka Leków,<br />

Ksawerów<br />

31/08/05<br />

31/08/05<br />

14/12/05<br />

9900 Owoc kopru włoskiego (1 i 2) Herbalux, Warszawa 31/12/08<br />

9901 Owoc kopru włoskiego 1 Herbapol Kraków 31/08/05<br />

9902 Owoc kopru włoskiego 1 Zioła Lecznicze Boguccy,<br />

Kraków<br />

9903 Owoc kopru włoskiego 1 i 2 Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

9904 Owoc kopru włoskiego 1 i 2<br />

(Foeniculi fix, Koper włoski fix)<br />

31/08/05<br />

31/12/08<br />

Herbapol Lublin 4/06/07<br />

9905 Owoc kopru włoskiego 2 Zakład Konfekcjonowania<br />

Ziół MALWA, Lubiszyn<br />

11/06/05<br />

9906 Owoc maliny 1 i 2 Herbalux, Warszawa 30/11/05<br />

9907 Owoc maliny 1 i 2 Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

30/11/05<br />

9908 Owoc róz˙y Herbapol Białystok 13/05/06<br />

9909 Owoc róz˙y Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

9910 Owoc róz˙y Zioła Lecznicze Boguccy,<br />

Kraków<br />

13/05/06<br />

13/05/06<br />

9911 Owoc róz˙y 1 Herbapol Kraków 31/03/05<br />

9912 Owoc róz˙y 1i2 Herbalux, Warszawa 30/04/05<br />

9913 Owoc Tarniny Herb Herbapol Lublin S.A. 30/10/05<br />

9914 Owocnia fasoli Phaseoli pericarpium A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

19/07/07<br />

9915 Owocnia fasoli Phaseoli pericarpium Herbalux, Warszawa 19/07/07<br />

9916 Owocnia fasoli Phaseoli pericarpium Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

19/07/07<br />

9917 Owocnia fasoli Herb Bogucki, Kraków 19/07/07<br />

9918 Owocnia fasoli Herb Bydgoskie Zakłady Zielarskie<br />

‘Herbapol’<br />

19/07/07<br />

9919 Owulavit Bional Pharma BV 31/12/08


EN<br />

1176 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9920 Oxalin 0,025 % Oxymetazolini<br />

hydrochloridum<br />

9921 Oxalin 0,025 % Oxymetazolini<br />

hydrochloridum<br />

9922 Oxalin 0,05 % Oxymetazolini<br />

hydrochloridum<br />

9923 Oxalin 0,05 % Oxymetazolini<br />

hydrochloridum<br />

9924 Oxaliplatin Oxiliplatinum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

9925 Oxaliplatin 50 Oxaliplatinum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

Nasal drops 0.25 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Nasal gel 0.25 mg/g Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Nasal drops 0.5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Nasal gel 0.5 mg/g Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

100 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

50 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

9926 Oxazepam Oxazepamum Tablets 10 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

9927 Oxfenil Oksfendazol Suspension for veterinary<br />

use<br />

30/09/05<br />

30/09/05<br />

30/09/05<br />

30/09/05<br />

31/12/08<br />

31/12/08<br />

31/12/05<br />

Virbac 31/12/08<br />

9928 Oximag Magnesii oxidum Film-coated tablets 66 mg Mg ++ Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/01/06<br />

9929 Oxis Turbuhaler Formoterolum Powder nebuliser 4.5 mcg/dawke˛ AstraZeneca AB 30/11/04<br />

9930 Oxis Turbuhaler Formoterolum Powder nebuliser 9 mcg/dawke˛ AstraZeneca AB 30/11/04<br />

9931 Oxsoralen Methoxsalenum Capsules 10 mg Gerot Pharmazeutika GmbH 31/07/04<br />

9932 Oxsoralen Methoxsalenum Coutanous liquid 10 mg/ml Gerot Pharmazeutika GmbH 31/07/04<br />

9933 OXY — 10 Lotion Benzoylis peroxydum Cutaneous suspension 100 mg/g SmithKline Beecham plc 31/07/04<br />

9934 Oxy 10 Cover Up Benzoylis peroxydum Cream 100 mg/g SmithKline Beecham<br />

Consumer Healthcare<br />

23/11/05<br />

9935 Oxycardil 60 Diltiazemum Film-coated tablets 60 mg Schwarz Pharma Sp. z o.o. 30/11/05<br />

9936 Oxycardil 120 Diltiazemum Prolonged release<br />

tablets<br />

9937 Oxycardil 180 Diltiazemum Film-coated, prologed<br />

release tablets<br />

9938 Oxycardil 240 Diltiazemum Film-coated, prologed<br />

release tablets<br />

9939 Oxycontin Oxycodonum Film-coated, modified<br />

release tablets<br />

9940 Oxycontin Oxycodonum Film-coated, modified<br />

release tablets<br />

9941 Oxycontin Oxycodonum Film-coated, modified<br />

release tablets<br />

9942 Oxycontin Oxycodonum Film-coated, modified<br />

release tablets<br />

9943 Oxycort Hydrocortisonum +<br />

Oxytetracyclinum<br />

Cutaneous spray (1,67mg +<br />

5mg)/ml<br />

120 mg Schwarz Pharma Sp. z o.o. 30/11/05<br />

180 mg Schwarz Pharma Sp. z o.o. 31/12/05<br />

240 mg Schwarz Pharma Sp. z o.o. 31/12/05<br />

10 mg Kutnowskie Zakłady<br />

Farmaceutyczne Polfa Kutno<br />

S.A.<br />

20 mg Kutnowskie Zakłady<br />

Farmaceutyczne Polfa Kutno<br />

S.A.<br />

40 mg Kutnowskie Zakłady<br />

Farmaceutyczne Polfa Kutno<br />

S.A.<br />

80 mg Kutnowskie Zakłady<br />

Farmaceutyczne Polfa Kutno<br />

S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/05/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1177<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9944 Oxycort Hydrocortisonum +<br />

Oxytetracyclinum<br />

9945 Oxycort A Hydrocortisonum +<br />

Oxytetracyclinum<br />

9946 Oxyflex XLA oksytetracyklina,<br />

fluniksyna<br />

Ointment (10mg +<br />

30mg)/g<br />

Eye ointment (30mg +<br />

30mg)/3g<br />

Solution for veterinary<br />

use<br />

9947 Oxyject 10 % Oxytetracyclinum Solution for veterinary<br />

use<br />

9948 Oxyject 20 % L.A. Oxytetracyclinum Solution for veterinary<br />

use<br />

9949 Oxymed 50 % Oxytetracyclinum Powder for veterinary<br />

use<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

31/12/08<br />

Norbrook 31/12/08<br />

Dopharma International B.V. 3/11/05<br />

Dopharma 30/06/04<br />

Dopharma 31/12/08<br />

9951 Oxytac Oxymetazolum Nasal drops 0,03 % US Pharmacia 31/12/08<br />

9950 Oxytac Oxymetazolum Nasal spray 0,03 % US Pharmacia 31/12/08<br />

9953 Oxytac Junior Oxymetazolum Nasal drops 0,01 % US Pharmacia 31/12/08<br />

9952 Oxytac Junior Oxymetazolum Nasal spray 0,01 % US Pharmacia 31/12/08<br />

9954 Oxytac Max Oxymetazolum Nasal drops 0,05 US Pharmacia 31/12/08<br />

9955 Oxyterracyna 3 % Oxytetracyclinum Ointment 30 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

9956 Oxytet 10 % Oxytetracyclinum Solution for veterinary<br />

use<br />

9957 Oxytet LA Oxytetracyclinum Solution for veterinary<br />

use<br />

9958 Oxytet XLA Oxytetracyclinum Solution for veterinary<br />

use<br />

9959 Oxytetracycline 50 % Oxytetracyclinum Powder for veterinary<br />

use<br />

9960 Oxytetracyclinum wet. Aerozo Oxytetracyclinum Suspension for veterinary<br />

use<br />

9961 Oxytetracyklina 20 % L.A. Oxytetracyclinum Solution for veterinary<br />

use<br />

31/01/06<br />

Norbrook 9/11/04<br />

Norbrook 9/11/04<br />

Norbrook 31/12/08<br />

Dopharma B.V. 31/12/08<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

31/12/08<br />

Biowet Drwalew 31/12/08<br />

9963 Oxytocin Oxytocinum Solution for injection 5 j.m./ml Grindeks — Public Joint<br />

Stock Company<br />

9962 Oxytocin Oxytocinum Solution for<br />

intravenous infusion<br />

9964 Oxytocin pro.inj. Oxytocinum Solution for veterinary<br />

use<br />

9965 Oxytocin-ject Oxytocinum Solution for veterinary<br />

use<br />

9966 Oxytocinum 10 j.m. Oxytocinum Solution for veterinary<br />

use<br />

9967 Oxyvet Oxytetracyclinum Solution for veterinary<br />

use<br />

9968 Oxywet 200 Oxytetracyclinum Liquid for veterinary<br />

use<br />

30/06/05<br />

5 j.m./1 ml Gedeon Richter Ltd. 30/06/04<br />

Eurovet Animal Health B.V. 15/02/07<br />

Dopharma 31/12/08<br />

Vet-Agro Sp. z.o.o 28/05/06<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne Polfa<br />

21/05/04<br />

Biowet Puławy 31/12/08


EN<br />

1178 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9969 Oystercal Dtm 500 Calcii carbonas,<br />

Ergocalciferolum<br />

9970 P047 (Kloracef) Cefaclorum Film-coated,<br />

prolonged release<br />

tablets<br />

9971 PA — Olvac + PM + E szczepionka dla<br />

indyków przeciwko<br />

pomorowi<br />

rzekomemu, cholerze<br />

drobiu, krwotocznemu<br />

zapaleniu jelit i<br />

infekcjom Rimerella<br />

anatipestifer<br />

9972 Pabialgin Allobarbitalum +<br />

Propyphenazonum<br />

9973 Pabialgin P Allobarbitalum +<br />

Propyphenazonum<br />

9974 Pabitan Coffeinum +<br />

Paracetamolum<br />

Film-coated tablets 500 mg Ca2+<br />

+ 125 j.m. wit.<br />

D2<br />

Emulsion for veterinary<br />

use<br />

Powder for magistral<br />

formula<br />

Puritan's Pride Inc. 31/12/08<br />

500 mg Bioton Sp. z o.o. 31/12/08<br />

(120mg +<br />

880mg)/g<br />

Tablets 30mg +<br />

220mg<br />

Tablets 65mg +<br />

500mg<br />

9975 Paclitaksel WZF 30 Paclitaxelum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

30 mg<br />

paklitakselu<br />

(fiolka)<br />

Fatro 31/12/08<br />

Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

9976 Paclitaxel Paclitaxelum Solution for injection 6mg/ml PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

9977 Padma 28 Preparat ziołowy Tablets Tymofarm —<br />

Przedsie˛biorstwo Rolno-<br />

Przetwórcze<br />

9978 Paeonia Complexe Lehning<br />

nr 104<br />

29/06/05<br />

31/12/07<br />

16/09/06<br />

31/12/08<br />

31/12/08<br />

31/01/05<br />

Drops Lehning Laboratoires 11/11/06<br />

9979 Paeonia-Heel Ointment Heel GmbH 31/07/05<br />

9980 Paeonia-Heel Tablets Heel GmbH 31/07/05<br />

9981 Pagosid Tablets 0.41 g Dr Dűnner Kirchberg 31/12/07<br />

9983 Palin Acidum pipemidicum Capsules 200 mg Lek Pharmaceuticals d.d. 30/06/04<br />

9984 Palin Acidum pipemidicum Capsules 200 mg Lek Polska Sp. z o.o. 31/12/05<br />

9982 Palin Acidum pipemidicum Vaginal suppository 200 mg Lek Pharmaceuticals d.d. 30/06/04<br />

9985 Palladone- Sr Hydromorphonum Modified release<br />

capsules<br />

9986 Palladone- Sr Hydromorphonum Modified release<br />

capsules<br />

9987 Palladone- Sr Hydromorphonum Modified release<br />

capsules<br />

9988 Palladone- Sr Hydromorphonum Modified release<br />

capsules<br />

9989 Palmivax Szczepionka przeciw<br />

chorobie Derzsyego<br />

9990 P-AM Maternal Dieta w fenyloketonurii Powder for oral<br />

solution<br />

9991 P-AM Universal Dieta w fenyloketonurii Powder for oral<br />

solution<br />

1, 78 mg<br />

hydromorfonu<br />

3,56 mg<br />

hydromorfonu<br />

7,12 mg<br />

hydromorfonu<br />

14,24 mg<br />

hydromorfonu<br />

Lyophilisate + solvent for veterinary<br />

use<br />

POLFA KUTNO S.A. 31/12/08<br />

POLFA KUTNO S.A. 31/12/08<br />

POLFA KUTNO S.A. 31/12/08<br />

POLFA KUTNO S.A. 31/12/08<br />

Merial SAS 31/12/08<br />

SHS International Ltd. 31/12/08<br />

SHS International Ltd. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1179<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

9992 PAMIDRONAT TORREX<br />

15 mg/ml<br />

Natrii pamidronas Concentrate for<br />

solution for infusion<br />

9993 Pamifos-15 Acidum pamidronicum Powder and solvent<br />

for solution for<br />

infusion<br />

9994 Pamifos-30 Acidum pamidronicum Powder and solvent<br />

for solution for<br />

infusion<br />

9995 Pamifos-60 Acidum pamidronicum Powder and solvent<br />

for solution for<br />

infusion<br />

9996 Pamifos-90 Acidum pamidronicum Powder and solvent<br />

for solution for<br />

infusion<br />

9997 Pana — Zink Enzyme + Vitamins +<br />

Zinc<br />

9998 Pana Veyxal Pankreatyna, Trypsyna,<br />

Chymotrypsyna,<br />

Papaina, Witamina A,<br />

Octan tokoferolu<br />

9999 Pana Veyxal Spray bezbarwny Enzyme + Vitamins +<br />

Zinc<br />

10000 Pana Veyxal Spray z˙ółty Enzyme + Vitamins +<br />

Zinc<br />

Suspension for veterinary<br />

use<br />

Ointment for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

10001 Panacur Granulat Fenbendazol Granules for veterinary<br />

use<br />

10002 Panacur Pasta Fenbendazol Paste for veterinary<br />

use<br />

10003 Panacur tabletki Fenbendazol Tablet for veterinary<br />

use<br />

15 mg/ml Torrex Pharma GmbH 31/12/08<br />

15 mg VIPHARM S.A. 21/03/07<br />

30 mg VIPHARM S.A. 21/03/07<br />

60 mg VIPHARM S.A. 21/08/07<br />

90 mg VIPHARM S.A. 21/03/07<br />

Veyx Pharma 31/12/08<br />

Veyx-Pharma 10/02/04<br />

Veyx Pharma 31/12/08<br />

Veyx Pharma 31/12/08<br />

Intervet International B.V. 30/04/04<br />

Intervet 30/04/04<br />

Intervet 14/06/04<br />

10004 Panadol Baby & Infant Paracetamolum Oral suspension 120 mg/5ml SmithKline Beecham<br />

Consumer Healthcare<br />

10005 Panadol Extra Coffeinum +<br />

Paracetamolum<br />

Film-coated tablets 65mg +<br />

500mg<br />

SmithKline Beecham<br />

Consumer Healthcare<br />

10006 Panadol Rapid Paracetamolum Film-coated tablets 500 mg SmithKline Beecham<br />

Consumer Healthcare Glaxo<br />

SmithKline Export Ltd.<br />

10007 Panadol Soluble Tablets Paracetamolum Effervescent tablets 500 mg SmithKline Beecham<br />

Consumer Healthcare<br />

10008 Panadol Tablets Paracetamolum Film-coated tablets 500 mg SmithKline Beecham<br />

Consumer Healthcare<br />

10009 Panaxan Ginseng radix Capsules, hard 9 mg<br />

ginsenozydów<br />

30/06/04<br />

30/06/04<br />

27/06/07<br />

30/06/04<br />

31/03/04<br />

Phytopharm Kle˛ka S.A. 31/08/05<br />

10010 Panaxan Ginseng tinctura Oral solution Phytopharm Kle˛ka S.A. 30/11/05<br />

10011 Panclor Cefaclorum Capsules 250 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

10012 Panclor Cefaclorum Capsules 500 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

10013 PANCREAS/ ELAZO ME-<br />

TEORYTOWE amp.<br />

17/10/06<br />

17/10/06<br />

WALA-Heilmittel GmbH 19/03/05


EN<br />

1180 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10014 Pancreatin 10000 Pancreatinum Capsules Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

10015 Pancrosan Mieszanka ziołowa Herbal tea Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

10016 Pancuronium Pancuronii bromidum Liquid for injection 4 mg/2 ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

10017 Pandex 1 % Iwermektyna Solution for veterinary<br />

use<br />

31/12/08<br />

30/10/05<br />

31/12/07<br />

Biovet Joint Stodk Company 29/08/06<br />

10018 Pangrol 10000 Pancreatinum Capsules 10000 j.Ph.Eur. Berlin-Chemie AG (Menarini<br />

Group)<br />

10019 Pangrol 25000 Pancreatinum Capsules 25000 j.Ph.Eur. Berlin-Chemie AG (Menarini<br />

Group)<br />

10020 Pankreaflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

10021 Panolog Nystatyna, Neomycyny<br />

siarczan, Tiostrepton,<br />

Triamcinolonu<br />

acetonid<br />

10022 Panpiryna Tabletki od bólu<br />

głowy<br />

Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Paracetamolum<br />

10023 Pantazol Pantoprazole Modified release<br />

tablets<br />

Suspension for veterinary<br />

use<br />

16/05/07<br />

16/05/07<br />

31/03/05<br />

Novartis Animal Health Inc. 25/06/04<br />

Tablets Cyntfarm Sp. z o.o. 31/03/06<br />

20 mg i 40 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

31/12/08<br />

10024 Panthenol Dexpanthenolum Cutaneous spray 46.3 mg/g Chauvin ankerpharm GmbH 31/08/04<br />

10025 Panthenol Dexpenthenolum Cream 5 % Aflofarm 31/12/08<br />

10026 Pantoprazole Pantoprazolum Solution for injection PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10027 Pantoprazole Pantoprazolum Tablets PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10028 Panvitan — Zestaw<br />

witaminowy dla kobiet<br />

10029 Panvitan — Zestaw<br />

witaminowy dla me˛z˙czyzn<br />

10030 Panvitan — Zestaw<br />

witaminowy dla osób starszych<br />

31/12/08<br />

31/12/08<br />

Film-coated tablets Bayer Corporation 30/06/07<br />

Film-coated tablets Bayer Corporation 30/06/07<br />

Film-coated tablets Bayer Corporation 30/06/07<br />

10031 Panvitan Baby Buccal tablet Bayer Corporation 31/12/08<br />

10032 Panvitan dla aktywnych Film-coated tablets Bayer Corporation 31/12/08<br />

10033 Panvitan Junior Buccal tablet Bayer Corporation 31/12/08<br />

10034 Panzytrat 10.000 Amylasum + Lipasum +<br />

Proteasum<br />

10035 Panzytrat 20.000 Amylasum + Lipasum +<br />

Proteasum<br />

10036 Panzytrat 25.000 Amylasum + Lipasum +<br />

Proteasum<br />

Capsules 10000 j. lipazy Abbott GmbH & Co KG 31/07/04<br />

Capsules 20000 j. lipazy Abbott GmbH & Co KG 31/07/04<br />

Capsules 25000 j. lipazy Abbott GmbH & Co KG 30/06/04<br />

10037 Papaverinum hydrochloricum Papaverinum Solution for injection 20 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1181<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10038 Papaweryny chlorowodorek Farm-Impex s.j., Gliwice 19/11/07<br />

10039 Papaweryny chlorowodorek Pharma Cosmetic, Kraków 19/11/07<br />

10040 Papaweryny chlorowodorek Pharma Zentrale 19/11/07<br />

10041 Papaweryny chlorowodorek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

10042 Para III Z˙ywa szczepionka dla<br />

bydła przeciw<br />

zakaz˙eniom wirusem<br />

parainfluenzy typ 3<br />

10043 Paracecofin Paracetamolum +<br />

Coffeinum<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Film-coated tablets 500 mg +<br />

65 mg<br />

19/11/07<br />

Merial 22/11/06<br />

US Pharmacia 31/12/08<br />

10044 Paracemol Paracetamolum Syrup 0.12 g/5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/10/05<br />

10045 Paracenol Paracetamolum Granules for syrup 0.125 g/5 ml Sanofi Biocom Sp. z o.o. 31/12/07<br />

10046 Paracenol Paracetamolum Syrup 120 mg/5 ml Sanofi Biocom Sp. z o.o. 31/12/05<br />

10047 Paracenol Paracetamolum Tablets 0.5 g Sanofi Biocom Sp. z o.o. 31/12/06<br />

10073 Paracetamol Paracetamolum Oral suspension 120 mg/5ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

10059 Paracetamol Paracetamolum Powder for oral<br />

solution<br />

0.5 g Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/05<br />

31/12/07<br />

10048 Paracetamol Paracetamolum Suppository 125 mg Farmjug Sp. z o.o. 31/01/05<br />

10049 Paracetamol Paracetamolum Suppository 125 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/01/05<br />

10050 Paracetamol Paracetamolum Suppository 250 mg Farmjug Sp. z o.o. 31/01/05<br />

10051 Paracetamol Paracetamolum Suppository 250 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/01/05<br />

10052 Paracetamol Paracetamolum Suppository 500 mg Farmjug Sp. z o.o. 31/01/05<br />

10053 Paracetamol Paracetamolum Suppository 500 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

10054 Paracetamol Paracetamolum Suppository 80 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/01/05<br />

31/01/05<br />

10055 Paracetamol Paracetamolum Suppository 125 mg Farmina Sp. z o.o. 31/01/05<br />

10056 Paracetamol Paracetamolum Suppository 250 mg Farmina Sp. z o.o. 31/01/05<br />

10057 Paracetamol Paracetamolum Suppository 50 mg Farmina Sp. z o.o. 31/01/05<br />

10058 Paracetamol Paracetamolum Suppository 500 mg Farmina Sp. z o.o. 31/01/05<br />

10072 Paracetamol Paracetamolum Suspension 120 mg/5 ml Polfarmex Sp. z o.o. 31/01/05<br />

10060 Paracetamol Paracetamolum Syrup 120 mg /5ml Aflofarm 31/01/05<br />

10061 Paracetamol Paracetamolum Syrup 0.12 g/5 ml Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

10062 Paracetamol Paracetamolum Syrup 120 mg/5ml Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

31/01/05<br />

31/01/05<br />

10063 Paracetamol Paracetamolum Tablets 0.5 g P.P.H.U. Biofarm Sp. z o.o. 31/01/05


EN<br />

1182 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10064 Paracetamol Paracetamolum Tablets 0.5 g Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/07<br />

10065 Paracetamol Paracetamolum Tablets 0.5 g Marcmed s.c. 31/01/05<br />

10066 Paracetamol Paracetamolum Tablets 250 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/03/07<br />

10067 Paracetamol Paracetamolum Tablets 500 mg Krka d.d., Novo mesto 31/01/05<br />

10068 Paracetamol Paracetamolum Tablets 500 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

10069 Paracetamol Paracetamolum Tablets 500 mg Chance — Zakład Produkcji<br />

Chemiczno —<br />

Farmaceutycznej s.c.<br />

30/09/05<br />

31/01/05<br />

10070 Paracetamol Paracetamolum Tablets 500 mg Polfarmex S.A 31/01/05<br />

10071 Paracetamol Paracetamolum Tablets 500 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

10074 Paracetamol 0,5 Paracetamolum Tablets 500 mg Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

10075 Paracetamol 0,5 Paracetamolum Tablets 500 mg Filofarm Farmaceutyczna<br />

Spółdzienia Pracy<br />

10076 Paracetamol 500 Paracetamolum Tablets 500 mg Aflofarm Fabryka Leków Sp.<br />

z o.o.<br />

10077 PARACETAMOL 500 mg<br />

Cyntfarm<br />

10078 Paracetamol o smaku<br />

malinowym<br />

10079 Paracetamol o smaku<br />

truskawkowym<br />

10080 Paracevit Paracetamolum +<br />

Acidum ascorbicum<br />

10081 Paracevit Paracetamolum +<br />

Acidum ascorbicum<br />

Paracetamolum Tablets 500 mg CYNTFARM Sp. z o.o.,<br />

Pruszków<br />

Paracetamolum Tablets 150 mg Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

Paracetamolum Tablets 150 mg Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

Film-coated tablets 250 mg +<br />

100 mg<br />

Film-coated tablets 500mg +<br />

200 mg<br />

10082 Paracillin Amoxicillunum Powder for veterinary<br />

use<br />

10083 Paracofen Azitheomycinum Tablets 500 mg +<br />

65 mg<br />

10084 Paracofen Plus Paracetamolum +<br />

Coffeinum +<br />

Pseudoephedrinum<br />

10085 Paracold Paracetamolum<br />

+Coffeinum +<br />

Phenylephrinum<br />

10086 Paracox Z˙ywa, atenuowana<br />

szczepionka dla<br />

kurcza˛t przeciwko<br />

kokcydiozie<br />

10087 Paracox-5 Szczepionka dla<br />

kurcza˛t przeciw<br />

kokcydiozie<br />

Film-coated tablets 500 mg +<br />

50 mg +<br />

30 mg<br />

Film-coated tablets preparat<br />

złoz˙ony<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

15/03/06<br />

31/03/07<br />

31/03/07<br />

31/12/08<br />

31/12/08<br />

11/10/06<br />

11/10/06<br />

31/12/08<br />

31/12/08<br />

Intervet 14/03/04<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

US Pharmacia 31/12/08<br />

Schering-Plough Ltd. 7/02/05<br />

Schering-Plough Central East<br />

Ag<br />

25/08/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1183<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10088 Paradentosol Oromucosal solution Elanda s.c. — Zakład<br />

Produkcji S´ rodków<br />

Farmaceutycznych<br />

10089 Paradex Plus Paracetamolum +<br />

Pseudoephedrinum +<br />

Dextromethorphanum<br />

Film-coated tablets 500 mg +<br />

30 mg +<br />

15 mg<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10090 Parafina ciekła Aflofarm Farmacja Polska,<br />

Pabianice<br />

30/10/05<br />

31/12/08<br />

19/01/05<br />

10091 Parafina ciekła AUGMED, Dawidy Bankowe 19/01/05<br />

10092 Parafina ciekła Avena, Bydgoszcz 19/01/05<br />

10093 Parafina ciekła Cefarm Cze˛stochowa 19/01/05<br />

10094 Parafina ciekła Cefarm Gdańsk 19/01/05<br />

10095 Parafina ciekła Elissa, Warszawa 19/01/05<br />

10096 Parafina ciekła Galenus, Rzeszów 19/01/05<br />

10097 Parafina ciekła Hasco-Lek, Wrocław 19/01/05<br />

10098 Parafina ciekła Infarm, Gdynia 19/01/05<br />

10099 Parafina ciekła Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

19/01/05<br />

10100 Parafina ciekła Lefarm, Bydgoszcz 19/01/05<br />

10101 Parafina ciekła Maga-Herba s.c., Legionowo 19/01/05<br />

10102 Parafina ciekła Maggie, Warszawa 19/01/05<br />

10103 Parafina ciekła Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

19/01/05<br />

10104 Parafina ciekła Pampa, Piaseczno 19/01/05<br />

10105 Parafina ciekła PPF GEMI, Karczew 19/01/05<br />

10106 Parafina ciekła PZF ‘Cefarm-Lublin’ S.A. 19/01/05<br />

10107 Parafina ciekła Semifarm, Gdańsk 19/01/05<br />

10108 Parafina ciekła Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

19/01/05<br />

10109 Parafina ciekła Marcol 352 Esso S.A.F. 9/03/06<br />

10110 Parafina stała Infarm, Gdynia 31/12/08<br />

10111 Parafina stała Lefarm, Bydgoszcz 31/12/08<br />

10112 Parafina stała Pharma Cosmetic, Kraków 31/12/08<br />

10113 Parafina stała Pharma Zentrale 31/12/08<br />

10114 Parafina stała PPF GEMI, Karczew 31/12/08<br />

10115 Parafina stała Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

31/12/08<br />

10116 Paragrippe Tablets Laboratoires BOIRON 31/12/07


EN<br />

1184 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10117 Paramectin Premix iwermektyna Premix for veterinary<br />

use<br />

Norbrook 31/12/08<br />

10118 Paramol Paracetamolum Syrup 120 mg/10 ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

10119 Paranalgin Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Paracetamolum<br />

10120 Parapasta Cinchocainum +<br />

Paraldehydum<br />

Tablets Espefa Chemiczno-<br />

Farmaceutyczna Spółdzielnia<br />

Pracy<br />

Paste (350mg +<br />

420mg)/g<br />

Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

31/12/08<br />

30/09/05<br />

30/10/05<br />

10121 Paraplatin Carboplatinum Solution for injection 10 mg/ml Bristol-Myers Squibb S.p.A. 6/12/05<br />

10122 Paraproxy Paracetamolum +<br />

Dextropropoxypheni<br />

hydrochloridum<br />

10123 Paraquistel Plus prazikwantel, pyrantel,<br />

febantel<br />

Tablets Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

Tablets for veterinary<br />

use<br />

10124 Parasitex Quick Bendiokarbum Collar for veterinary<br />

use<br />

10125 Paratex prazikwantel,<br />

pyrantelu embonian<br />

Tablets for veterinary<br />

use<br />

31/12/08<br />

Laboratiorios Calier SA 31/12/08<br />

Virbac 25/08/04<br />

Lavet 31/12/08<br />

10126 Paravir Zidovudinum Capsules 100 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10127 Paravir Zidovudinum Capsules 250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10128 Paravitan Paracetamolum +<br />

Acidum ascorbicum<br />

10129 Paravitan Plus Paracetamolum +<br />

Acidum ascorbicum+<br />

Phenylephrini<br />

hydrochloridum<br />

10130 Paravitan Pp Paracetamolum +<br />

Acidum ascorbicum+<br />

Phenylephrinum<br />

10131 Pareira-Dagomed 10 łagodny<br />

przerost prostaty<br />

powder for solution 500 mg +<br />

60 mg<br />

powder for solution praparat<br />

złoz˙ony<br />

powder for solution praparat<br />

złoz˙ony (inne<br />

proporcje<br />

składników)<br />

10132 Parentamin 10 % Amino acid solution<br />

for intravenous<br />

infusion<br />

10133 Parentamin 10 % E Amino acid solution<br />

for intravenous<br />

infusion<br />

10134 Pariet Rabeprazolum Gastro-resistant<br />

tablets<br />

10135 Pariet Rabeprazolum Gastro-resistant<br />

tablets<br />

31/12/08<br />

31/12/08<br />

US Pharmacia 31/12/08<br />

US Pharmacia 31/12/08<br />

US Pharmacia 31/12/08<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

Serag-Wiessner KG 30/06/04<br />

Serag-Wiessner KG 30/06/04<br />

10 mg Janssen Pharmaceutica N.V. 30/06/05<br />

20 mg Janssen Pharmaceutica N.V. 30/06/05<br />

10136 Parkinil 10 Selegilinum Tablets 10 mg Sanofi-Synthelabo Sp. z o.o. 26/04/06<br />

10137 Parkinil 5 Selegilinum Tablets 5 mg Sanofi-Synthelabo Sp. z o.o. 26/04/06<br />

10138 Parkopan 2 Trihexyphenidylum Tablets 2 mg Hexal AG 31/05/05<br />

10139 Parkopan 5 Trihexyphenidylum Tablets 5 mg Hexal AG 31/05/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1185<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10140 Parlazin Cetirizinum Oral drops, solution 10 mg/ml Egis Pharmaceuticals Ltd. 31/12/08<br />

10141 Parlazin Cetirizinum Tablets 10 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

10142 Parlodel Bromocriptinum Tablets 2.5 mg Novartis Pharma AG 31/05/04<br />

10143 Parnaparyna Parnaparinum natricum Solution for injection 3200 j.m. /<br />

0,3 ml<br />

10144 Parnaparyna Parnaparinum natricum Solution for injection 6400 j.m. /<br />

0,6 ml<br />

10145 Parogencyl Bi — Actif o<br />

smaku cytrynowym<br />

10146 Parogencyl Bi — Actif o<br />

smaku mie˛towym<br />

Dexpanthenolum +<br />

Metesculetolum<br />

Dexpanthenolum +<br />

Metesculetolum<br />

10147 Parogencyl Bi-Actif Dexpanthenolum +<br />

Metesculetolum<br />

10148 Paroplak Chlorhexidinum + Natrii<br />

fluoridum<br />

Toothpaste (10mg +<br />

2,5mg)/g<br />

Toothpaste (10mg +<br />

2,5mg)/g<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

Synthelabo Group.<br />

Laboratoires Synthelabo<br />

Synthelabo Group.<br />

Laboratoires Synthelabo<br />

Mouth wash solution (5mg + 1mg)/g Synthelabo Group.<br />

Laboratoires Synthelabo<br />

Mouth wash solution (3mg +<br />

0,5mg)/g<br />

Synthelabo Group.<br />

Laboratoires Synthelabo<br />

10149 PAROXETINE PLIVA 20 mg Paroxetinum Film-coated tablets 20 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10150 PAROXETINE PLIVA 30 mg Paroxetinum Film-coated tablets 30 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10151 Partobulin — Inject Anti-D (rh)<br />

immunoglobulinum<br />

(globulina ludzka anty<br />

Rh (D)<br />

10152 Parvigen Atenuowana<br />

szczepionka dla psów<br />

przeciw<br />

parwowirusowej<br />

chorobie psów<br />

10153 Parvodog Szczepionka przeciw<br />

parwowirozie psów<br />

10154 Parvoject Szczepionka dla s´wiń<br />

przeciw zakaz˙eniom<br />

parwowirusowym<br />

10155 Parvoruvax Inaktywowana<br />

szczepionka dla s´wiń<br />

przeciw parwowirozie<br />

i róz˙ycy<br />

10156 Parvosorb Szczepionka dla s´wiń<br />

przeciwko<br />

parwowirozie s´wiń<br />

10157 Parvosuin MR inaktywowana<br />

szczepionka dla s´wiń<br />

przeciwko<br />

parwowirozie i róz˙ycy<br />

10158 Parwoglobulina Gamma-globulina<br />

przeciw<br />

parwowirusowej<br />

chorobie psów<br />

Solution for<br />

intramuscular<br />

injection<br />

250 mcg/ml<br />

immunoglobulinyprzeciwte˛z˙cowej<br />

ludzkiej<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

30/04/04<br />

30/04/04<br />

30/10/05<br />

30/04/04<br />

31/12/08<br />

31/12/08<br />

Baxter AG 30/06/07<br />

Virbac S.A. 24/06/07<br />

Merial 30/06/04<br />

Merial 9/06/05<br />

Merial SAS 24/06/07<br />

Hoechst Russel 31/12/08<br />

Hipra 31/12/08<br />

Biowet Puławy 25/04/06<br />

10159 Pascodolor krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

30/11/05


EN<br />

1186 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10160 Pascofemin krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

10161 Pascosabal N krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

10162 Passibil Crataegi inflorescentiae<br />

extr. sicc., Ginkgo<br />

bilobae extr. sicc.,<br />

Passiflorae extr. sicc.<br />

Capsules 80 mg +<br />

40 mg +<br />

20 mg<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

10163 Passibil Preparat ziołowy Liquid Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

10164 Passiflor Passiflorae extractum<br />

fluidum<br />

30/11/05<br />

30/11/05<br />

31/12/08<br />

31/12/08<br />

Liquid Phytopharm Kle˛ka S.A. 31/12/08<br />

10165 Passiflora Suppository 1g WALA-Heilmittel GmbH 24/05/07<br />

10166 Passiflora WALA-Heilmittel GmbH 24/05/07<br />

10167 Passiflora Suppository 2g WALA-Heilmittel GmbH 24/05/07<br />

10168 Passiflora compose krople Dolisos Laboratoires 31/12/08<br />

10169 Passiflora G.H.L. Lehning Laboratoires 31/10/05<br />

10170 Passispasmin Syrup Herbapol Lublin S.A. 30/10/05<br />

10171 Passispasmol Drops Herbapol Lublin S.A. 31/12/07<br />

10172 Pasta borowinowa lecznicza Preparat złoz˙ony Cutaneous paste Michalik 30/10/05<br />

10173 Pasta cynkowa Zinci oxydum Ointment Farmina Sp. z o.o. 31/12/05<br />

10174 Pasta cynkowa Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/05<br />

10175 Pasta cynkowa Apipol-Farma, Mys´lenice 31/12/05<br />

10176 Pasta cynkowa Avena, Bydgoszcz 31/12/05<br />

10177 Pasta cynkowa Cefarm Gdańsk 31/12/05<br />

10178 Pasta cynkowa Farmina Sp. z o.o., Kraków 31/12/05<br />

10179 Pasta cynkowa Hasco-Lek, Wrocław 31/12/05<br />

10180 Pasta cynkowa Pharma Cosmetic, Kraków 31/12/05<br />

10181 Pasta cynkowa Pharma Zentrale 31/12/05<br />

10182 Pasta cynkowa PZF ‘Cefarm-Lublin’ S.A. 31/12/05<br />

10183 Pasta cynkowa Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

10184 Pasta cynkowa z kwasem<br />

salicylowym<br />

10185 Pasta Lassara — mas´ć cynkowa<br />

z kwasem salicylowym<br />

10186 Pasta Z Balsamem<br />

Peruwiańskim<br />

Acidum salicylicum +<br />

Zinci oxydum<br />

31/12/05<br />

PPF GEMI, Karczew 3/09/06<br />

Paste Ziaja Ltd. — Zakład<br />

Produkcji Leków<br />

Preparat złoz˙ony Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne ‘Coel’<br />

Kraków<br />

10187 Pasta Zinci Zinci oxydum Paste Ziaja Ltd. — Zakład<br />

Produkcji Leków<br />

31/12/04<br />

31/12/08<br />

31/12/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1187<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10188 Pasta Zinci — Pasta Cynkowa Zinci oxydum Paste Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

10189 Pasteryzowana ludzka<br />

immunoglobulina<br />

przeciwte˛z˙cowa 250<br />

10190 Pasteryzowana ludzka<br />

immunoglobulina<br />

przeciwte˛z˙cowa 500<br />

Tetanus immunoglobulin Lyophilisate for<br />

intramuscular<br />

injection<br />

Tetanus immunoglobulin Lyophilisate for<br />

intramuscular<br />

injection<br />

10191 Pastivac E Szczepionka dla ge˛si<br />

przeciw pasterelozie<br />

10192 Pastobov Szczepionka dla bydła<br />

przeciwko zakaz˙eniom<br />

układu oddechowego<br />

wywoływanym przez<br />

pasteurella multocide<br />

10193 Pastylki Wykrztus´ne Guaiacolsulfonatum +<br />

Glycyrrhizae extr.<br />

Oil emulsion for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Buccal tablet 200mg +<br />

10mg<br />

31/12/06<br />

250 j.m. Instituto Grifols S.A. 31/12/08<br />

500 j.m. Instituto Grifols S.A. 31/12/08<br />

Biowet Puławy Sp. z o.o. 15/01/06<br />

Merial 30/09/07<br />

Przedsie˛biorstwo<br />

Produkcyjno-Handlowe ‘EWA’<br />

S.A.<br />

31/12/05<br />

10194 Patentex Oval N Nonoxinolum Pessary 75 mg Merz & Co. GmbH 31/07/04<br />

10195 Pathozone Cefoperazon jako sól<br />

sodowa<br />

10196 Pausogest Estradiolum +<br />

Norethisteronum<br />

Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

Pfizer 4/03/04<br />

Film-coated tablets Chemical Works of Gedeon<br />

Richter Ltd.<br />

10197 Pauzin M Mesterolonum Tablets 25 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

10198 Pavulon Pancuronii bromidum Solution for<br />

intravenous injection<br />

31/12/08<br />

31/12/08<br />

2 mg/ml Organon N.V. 31/07/04<br />

10199 Paxeladine® 0,2 % Oxeladinum Syrup 2 % Beaufour Ipsen Pharma 31/12/08<br />

10200 Paxenor Paclitaxelum Concantrate for<br />

solution for<br />

intravenous infusion<br />

6 mg/ml Ivax Pharma Poland Sp. z o.o. 31/01/05<br />

10201 Paxeratio Paroxetinum Film-coated tablets 20 mg ratiopharm GmbH 31/12/08<br />

10202 Pa˛czki sosny Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/06/06<br />

10203 Pa˛czki sosny Herb HERBAPOL BIAŁYSTOK S.A. 31/12/08<br />

10204 Pa˛czki topoli Herb HERBAPOL BIAŁYSTOK S.A. 31/12/08<br />

10205 Pectobonisol Oral solution Bonimed Laboratorium<br />

Medycyny Naturalnej<br />

5/03/06<br />

10207 PectoDrill Carbocisteinum Buccal tablet 750 mg Pierre Fabre Sante 30/06/05<br />

10206 PectoDrill Carbocisteinum Syrup 5 g/100 ml Pierre Fabre Sante 30/06/05<br />

10208 Pectosol Preparat ziołowy Oral solution Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

30/10/05<br />

10209 Pectus-Heel Tablets Heel GmbH 31/07/05


EN<br />

1188 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10210 Pediacel Vaccinum diphtheriae<br />

tetani, pertussis sine<br />

cellulis ex elementis<br />

praeparatum<br />

poliomyelitidis<br />

inactivatum et<br />

haemophlili stripe b<br />

conjugatum adsorbatum<br />

Suspension for<br />

intramuscular<br />

injection<br />

0,5 ml Aventis Pasteur Limited 31/12/08<br />

10211 Pediasure Preparat odz˙ywczy Powder Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

10212 Pediasure (o smaku<br />

waniliowym)<br />

10213 Pediasure o smaku<br />

bananowym<br />

10214 PEDIASURE PLUS O Smaku<br />

Truskawkowym<br />

10215 PEDIASURE PLUS O Smaku<br />

Waniliowym<br />

Preparat odz˙ywczy Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

Preparat odz˙ywczy Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

Odz˙ywka Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

Odz˙ywka Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

10216 Pediflos Herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

10217 Pedipur Methenaminum Liquid powder 200 mg/g Prolab s.c. — Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Produkcyjno-Analityczno-<br />

Handlowe s.c. Paterek<br />

26/04/06<br />

14/03/06<br />

4/07/07<br />

31/12/08<br />

31/12/08<br />

30/04/05<br />

30/06/05<br />

10218 Peditrace Solution for infusion Fresenius Kabi AB Uppsala 31/12/07<br />

10219 Pedvax HIB Vaccinum haemophili<br />

stripe b conjugatum<br />

Suspension for<br />

intramuscular<br />

injection<br />

0.5 ml Merck Sharp & Dohme Idea<br />

Inc.<br />

31/05/05<br />

10221 Peflacine Pefloxacinum Film-coated tablets 400 mg Egis Pharmaceuticals Ltd. 31/07/04<br />

10220 Peflacine Pefloxacinum Solution for<br />

intravenous infusion<br />

80 mg/ml Egis Pharmaceuticals Ltd. 27/06/05<br />

10222 Pefloksacyna Pefloxacinum Film-coated tablets 400 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/10/05<br />

10223 Pefrakehl D5 krople Sanum-Kehlbeck 31/12/05<br />

10224 Pefrakehl D6 iniekcje Sanum-Kehlbeck 31/12/05<br />

10225 Pegasys Peginterferonum alfa —<br />

2a<br />

10226 Pegasys Peginterferonum alfa —<br />

2a<br />

10<strong>227</strong> Pegasys Peginterferonum alfa —<br />

2a<br />

10228 Pegasys Peginterferonum alfa —<br />

2a<br />

Solution for injection 135 µg;<br />

135 µg/ml<br />

Solution for injection 135 µg;<br />

270 µg/ml<br />

(135 µg/0,5 ml)<br />

Solution for injection 180 µg;<br />

180 µg/ml<br />

Solution for injection 180 µg;<br />

360 µg/ml<br />

(180 µg/ml)<br />

10229 PegIntron Interferonum alfa-2b Powder and solvent<br />

for solution for<br />

injection<br />

10230 PegIntron Interferonum alfa-2b Powder and solvent<br />

for solution for<br />

injection<br />

100 mcg/<br />

0,5 ml<br />

120 mcg/<br />

0,5 ml<br />

F. Hoffmann — La Roche<br />

Ltd.<br />

F. Hoffmann — La Roche<br />

Ltd.<br />

F. Hoffmann — La Roche<br />

Ltd.<br />

F. Hoffmann — La Roche<br />

Ltd.<br />

Schering-Plough Europe<br />

Bruksela<br />

Schering-Plough Europe<br />

Bruksela<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

5/07/06<br />

5/07/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1189<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10231 PegIntron Interferonum alfa-2b Powder and solvent<br />

for solution for<br />

injection<br />

10232 PegIntron Interferonum alfa-2b Powder and solvent<br />

for solution for<br />

injection<br />

10233 PegIntron Interferonum alfa-2b Powder and solvent<br />

for solution for<br />

injection<br />

150 mcg/<br />

0,5 ml<br />

Schering-Plough Europe<br />

Bruksela<br />

50 mcg/0,5 ml Schering-Plough Europe<br />

Bruksela<br />

80 mcg/0,5 ml Schering-Plough Europe<br />

Bruksela<br />

5/07/06<br />

5/07/06<br />

5/07/06<br />

10234 Pektosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

10235 Pektovit Herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

10236 Pektovit Herbal tea Phytopharm Dobrzyca Sp. z<br />

o.o.<br />

31/12/07<br />

31/12/07<br />

10237 Pektynki Tablets Sanofi-Synthelabo Sp. z o.o. 31/12/07<br />

10238 Pelethrocin Diosminum +<br />

Hesperydyna<br />

Film-coated tablets HELP S.A. Pharmaceuticals 14/03/07<br />

10239 Pelogel Gel Sulphur Zdrój Exim —<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

10240 Pendyst Benzylopenicylina<br />

prokainowa, siarczan<br />

dihydrostreptomycyny<br />

Suspension for veterinary<br />

use<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

31/12/08<br />

31/12/08<br />

10241 Penester Finasteridum Film-coated tablets 5 mg Lečiva a.s. 9/08/06<br />

10242 Penicillin Dihydrostreptomycin<br />

45 % (Streptopen 45 %)<br />

10243 Penicillin G Sodium<br />

>Biochemie<<br />

10244 Penicillin G Sodium<br />

>Biochemie<<br />

10245 Penicillin G Sodium<br />

>Biochemie<<br />

Penicylina prokainowa,<br />

siarczan<br />

streptomycyny,<br />

prokaina<br />

10246 Penicillin L.A. Penicylina prokainowa<br />

lecytynowa, Penicylina<br />

benzatynowa<br />

10247 Penicillin-S 20/20 Benzylpenicillinum<br />

procainicum +<br />

Dihydrostreptomycinum<br />

Suspension for veterinary<br />

use<br />

Benzylpenicillinum Intramuscular /<br />

intravenous injection<br />

(lyophilisate)<br />

Benzylpenicillinum Intramuscular /<br />

intravenous injection<br />

(lyophilisate)<br />

Benzylpenicillinum Intramuscular /<br />

intravenous injection<br />

(lyophilisate)<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

10248 Penicillinum Crystallisatum Benzylpenicillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

10249 Penicillinum Crystallisatum Benzylpenicillinum Powder for solution<br />

for intravascular and<br />

intramuscular<br />

injection<br />

Bela-Pharm 31/12/08<br />

1000000 j.m. Biochemie GmbH — Kundl 31/12/08<br />

5000000 j.m. Biochemie GmbH — Kundl 31/12/08<br />

10000000 j.m. Biochemie GmbH — Kundl 31/12/08<br />

Norbrook 15/10/04<br />

V.M.D. 31/12/08<br />

5000000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1000000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/07/05<br />

30/10/05


EN<br />

1190 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10250 Penicillinum Crystallisatum Benzylpenicillinum Powder for solution<br />

for intravascular and<br />

intramuscular<br />

injection<br />

10251 Penicillinum Crystallisatum Benzylpenicillinum Powder for solution<br />

for intravascular and<br />

intramuscular<br />

injection<br />

10252 Penicillinum Crystallisatum —<br />

natrium<br />

10253 Penicillinum Crystallisatum —<br />

natrium<br />

10254 Penicillinum Crystallisatum —<br />

natrium<br />

10255 Penicillinum Crystallisatum —<br />

natrium<br />

10256 Penicillinum Crystallisatum —<br />

natrium<br />

10257 Penicillinum Crystallisatum —<br />

natrium<br />

Benzylpenicillinum Dry substance for<br />

intravenous and<br />

intramuscular<br />

injection or for<br />

intravenous infusion<br />

Benzylpenicillinum Dry substance for<br />

intravenous and<br />

intramuscular<br />

injection or for<br />

intravenous infusion<br />

Benzylpenicillinum Dry substance for<br />

intravenous and<br />

intramuscular<br />

injection or for<br />

intravenous infusion<br />

Benzylpenicillinum Dry substance for<br />

intravenous and<br />

intramuscular<br />

injection or for<br />

intravenous infusion<br />

Benzylpenicillinum Dry substance for<br />

intravenous and<br />

intramuscular<br />

injection or for<br />

intravenous infusion<br />

Benzylpenicillinum Dry substance for<br />

intravenous and<br />

intramuscular<br />

injection or for<br />

intravenous infusion<br />

10258 Penicillinum procainicum Benzylpenicillinum Powder for<br />

suspension for<br />

intramuscular<br />

injection<br />

10259 Penicillinum procainicum Benzylpenicillinum Powder for<br />

suspension for<br />

intramuscular<br />

injection<br />

10260 Penicillinum procainicum Benzylpenicylina<br />

prokainowa<br />

10261 Penicillinum procainicum Benzylpenicillinum<br />

procainicum<br />

10262 Penicillinum Procainicum L Benzylpenicillinum<br />

procainum<br />

10263 Penicillinum Procainicum L Benzylpenicillinum<br />

procainum<br />

Powder for veterinary<br />

use<br />

Lyophilisated<br />

substance<br />

Powder for solution<br />

for intramuscular<br />

injections<br />

Powder for solution<br />

for intramuscular<br />

injections<br />

3000000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

600000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

100000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1000000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

200000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

3000000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

5000000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

600000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1200000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2400000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

for veterinary<br />

use<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

1 200 000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2 400 000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10264 Penigra Preparat złoz˙ony Capsules, soft Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

30/10/05<br />

30/10/05<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1191<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10265 Penillin 30 % Penicylina prokainowa Suspension for veterinary<br />

use<br />

10266 Penject 30 Benzylpenicillinum<br />

procainicum<br />

10267 Pen-Strep Dihydrostreptomycyny<br />

siarczan, Penicylina<br />

prokainowa<br />

10268 Pentact — HIB Szczepionka przeciwko<br />

H.influenzae, Błonnicy,<br />

Te˛z˙cowi, Krztus´cowi,<br />

Poliomyelitis typ 1, 2, 3<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Lyophilisate Act-HIB<br />

+ suspension DTP-IPV<br />

Norbrook 18/03/04<br />

Dopharma B.V. 25/03/07<br />

Norbrook 21/05/04<br />

Pasteur Merieux Connaught<br />

GmbH<br />

10269 Pentaerythritol 100 Pentaeritrityli tetranitras Tablets 100 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

10270 Pentaerythritol compositum Glyceroli trinitras +<br />

Pentaeritrityli tetranitras<br />

10272 Pentaerythritol Compositum Pentaerithrityli tetranitrs<br />

+ Glyceroli trinitras<br />

10271 Pentaerythritol Compositum Pentaerithrityli tetranitrs<br />

+ Glyceroli trinitras<br />

10273 Pentaglobin Immunoglobulinum<br />

humanum<br />

Tablets Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

Sublingual tablets 20 mg +<br />

0,5 mg<br />

Farmaceutyczna Spółdzielnia<br />

Pracy ‘GALENA’<br />

Tablets 80 mg + 5 mg Farmaceutyczna Spółdzielnia<br />

Pracy ‘GALENA’<br />

Solution for<br />

intravenous infusion<br />

10275 Pentasa Mesalazinum Prolonged release<br />

granules<br />

10276 Pentasa Mesalazinum Prolonged release<br />

tablets<br />

31/12/08<br />

25/01/06<br />

31/07/05<br />

31/07/05<br />

31/07/05<br />

50 mg/ml Biotest Pharma GmbH 30/04/04<br />

1 g Ferring A/S 23/11/05<br />

500 mg Ferring A/S 21/03/06<br />

10277 Pentasa Mesalazinum Rectal suspension 1 g/100 ml Ferring A/S 31/08/05<br />

10274 Pentasa Mesalazinum Suppository 1 g Ferring A/S 27/02/06<br />

10278 Pentavir Suis Szczepionka<br />

profilaktyczna dla<br />

prosia˛t<br />

10279 Pentaxim Vaccinum diphtheriae<br />

tetani, pertussis sine<br />

cellulis ex elementis<br />

praeparatum<br />

poliomyelitidis<br />

inactivatum et<br />

haemophlili stripe b<br />

conjugatum adsorbatum<br />

Suspension for veterinary<br />

use<br />

Powder and solvent<br />

for solution for<br />

intramuscular<br />

injection<br />

0,5 ml<br />

(szCZpionka 1<br />

— dawkowa)<br />

Biowet Puławy 31/12/08<br />

Aventis Pasteur S.A. 31/12/08<br />

10280 Pentazocinum Pentazocinum Solution for injection 30 mg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/05/05<br />

10281 Pentilin Pentoxifyllinum Solution for injection 20 mg/ml Krka d.d., Novo mesto 30/11/04<br />

10282 Pentilin Pentoxifyllinum Solution for injection<br />

and intravenous and<br />

intrarterial infusion<br />

10283 Pentilin Retard Pentoxifyllinum Film-coated, prologed<br />

release tablets<br />

10284 Pentohexal 300 Pentoxifyllinum Solution for<br />

intravenous injection<br />

10285 Pentohexal 600 retard Pentoxifyllinum Prolonged release<br />

tablets<br />

20 mg/ml Krka d.d., Novo mesto 27/09/06<br />

400 mg Krka d.d., Novo mesto 30/11/04<br />

20 mg/ml Hexal AG 30/01/05<br />

600 mg Hexal AG 30/01/05


EN<br />

1192 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10286 Pentomycin Benzylpenicillinum<br />

procainicum +<br />

Dihydrostreptomycinum<br />

10287 Pentosan Polysulfate Sp 54 Sól sodowa polisiarczanu<br />

pentozanu<br />

Suspension for veterinary<br />

use<br />

Solution for<br />

intravenous,<br />

intramuscular<br />

injection and for<br />

intravenous infusion<br />

Univet Ltd. 12/07/05<br />

100 mg/ml Bene — Arzneimittel GmbH 31/12/08<br />

10288 Pentoxyfillyn 400 Retard Pentoxifyllinum Tablets 400 mg ALIUD Pharma GmbH & Co.<br />

KG<br />

10289 Pentoxyfillyn 600 Retard Pentoxifyllinum Tablets 600 mg ALIUD Pharma GmbH & Co.<br />

KG<br />

10290 Pentoxyverin Pentoxyverinum Coated tablets 25 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10291 Peponen Cucrbitae peponis oleum Capsules, soft 300 mg Biogal Pharmaceutical Works<br />

Ltd.<br />

10292 Peposterol Sitosterolum Capsules 6 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

9/08/06<br />

30/10/05<br />

10293 Pepsyna BTL, Łódz´ 14/11/05<br />

10294 Pepsyna BUFA b.v. Pharmaceutical<br />

Products<br />

14/11/05<br />

10295 Pepsyna Pharma Cosmetic, Kraków 14/11/05<br />

10296 Peptisorb Preparat odz˙ywczy Liquid N.V. Nutricia 27/02/06<br />

10297 Peptisorb Preparat odz˙ywczy Powder Nutricia Cuijk B.V 20/08/06<br />

10298 Peracef Cefoperazonum Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

Pfizer 31/12/08<br />

10299 Perative Preparat odz˙ywczy Liquid diet Ross Products Division-<br />

Abbott Laboratories<br />

10300 Perazyna 100 Perazinum Tablets 100 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

10301 Perazyna 25 Perazinum Tablets 25 mg Farmaceutyczna Spółdzielnia<br />

Pracy Galena<br />

31/12/08<br />

25/05/05<br />

25/05/05<br />

10302 Perfalgan Paracetamolum Solution for infusion 10 mg/ml Laboratoires UPSA 31/12/08<br />

10303 Perfenil Perphenazinum Film-coated tablets 8 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

10304 Perfocrat Preparat ziołowy Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

10305 Pergolide Pergolidum Tablets 0,25 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10306 Pergolide Pergolidum Tablets 0,05 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10307 Pergolide Pergolidum Tablets 1 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10308 Pergonal 500 Human menopausal<br />

gonadotropin<br />

10309 Perhip Hyperici herbae<br />

extractum siccum<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

75 j.m. Laboratories Serono S.A. 30/06/04<br />

Capsules, soft 137 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1193<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10310 Perindopril Perindoprilum Tablets 4 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10311 Perindopril Perindoprilum Tablets 2 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10312 Perindopril + Indapamid Perindoprilum +<br />

Indapamidum<br />

10313 Perindopril + Indapamid Perindoprilum +<br />

Indapamidum<br />

10314 PERIODONTIUM/SILICEA<br />

comp., ampułki<br />

10315 PERIODONTIUM/-STANNUM<br />

comp. ampułki<br />

10316 Perionorm Agni casti fructus extr.<br />

sicc., Chlorowodorek<br />

pirydoksyny, Tlenek<br />

magnezu<br />

10317 Periplasmal 3,5 % z glukoza˛ Roztwór aminokwasów,<br />

glukozy i elektrolitów<br />

Tablets 4 mg +<br />

1,25 mg<br />

Tablets 2 mg +<br />

0,625 mg<br />

Capsules, hard 8 mg + 20 mg<br />

+ 200 mg<br />

Solution for<br />

intravenous infusion<br />

Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

Herbapol — Lublin S.A. 31/12/08<br />

B. Braun Melsungen AG 5/08/06<br />

10318 Peritol Cyproheptadinum Syrup 2 mg/5 ml Egis Pharmaceuticals Ltd. 30/06/04<br />

10319 Peritol Cyproheptadinum Tablets 4 mg Egis Pharmaceuticals Ltd. 30/06/04<br />

10320 Perizin Kumafos Solution for veterinary<br />

use<br />

10321 Perlinganit Glyceroli trinitras Solution for<br />

intravenous infusion<br />

10322 Perlinganit Glyceroli trinitras Solution for<br />

intravenous infusion<br />

10323 Permammas Metylu salicylan,<br />

Kamfora racemiczna,<br />

Mentol, Gwajakol<br />

Emulsion for veterinary<br />

use<br />

Bayer AG 24/05/07<br />

1 mg/ml Schwarz Pharma AG 31/05/04<br />

1 mg/ml Schwarz Pharma Sp. z o.o. 30/11/05<br />

Vetoquinol S.A. 19/12/06<br />

10324 Permax Pergolidum Tablets 0.05 mg Eli Lilly and Company Ltd 31/12/07<br />

10325 Permax Pergolidum Tablets 0.25 mg Eli Lilly and Company Ltd 31/12/07<br />

10326 Permax Pergolidum Tablets 1 mg Eli Lilly and Company Ltd 31/12/07<br />

10327 Permixon Capsuels, hard 160 mg Pierre Fabre Medicament 25/01/06<br />

10328 Permixon Film-coated tablets 80 mg Pierre Fabre Medicament 31/12/08<br />

10329 Pernazinum Perazinum Tablets 100 mg Labor Farmaceutyczno-<br />

Chemiczna Spółdzielnia Pracy<br />

10330 Pernazinum Perazinum Tablets 25 mg Labor Farmaceutyczno-<br />

Chemiczna Spółdzielnia Pracy<br />

10331 Pernazinum 0,025 Perazinum Tablets 25 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

10332 Pernazinum 0,1 Perazinum Tablets 100 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

10333 Perosall C Alergeny pyłków ros´lin Solution for<br />

sublingual use<br />

10334 Perosall D Alergeny pyłków ros´lin Solution for<br />

sublingual use<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

31/01/06<br />

31/01/06<br />

11/01/06<br />

11/01/06<br />

31/12/05<br />

31/12/05


EN<br />

1194 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10335 Perosall T13 Alergeny pyłków ros´lin Solution for<br />

sublingual use<br />

10336 Perosall T3 Alergeny pyłków ros´lin Solution for<br />

sublingual use<br />

10337 Peroxydental 0,5 Hydrogenium<br />

peroxydatum<br />

10338 Peroxygel 2,0 Hydrogenium<br />

peroxydatum<br />

10339 Peroxyl — Dental Hydrogenium<br />

peroxydatum<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

Gel Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Gel Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Gel 1 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

10340 Persantin 75 Dipyridamolum Coated tablets 75 mg Boehringer Ingelheim<br />

International GmbH<br />

31/12/05<br />

31/12/04<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/04/04<br />

10341 Persen Coated tablets Lek Pharmaceuticals d.d. 30/04/04<br />

10342 Persen forte Capsules Lek Pharmaceuticals d.d. 30/04/04<br />

10343 Pertlenon Tablets for solution Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’, Bydgoszcz<br />

30/09/05<br />

10344 Pertudoron 1 krople WELEDA 24/08/05<br />

10345 Pertudoron 2 krople WELEDA 24/08/05<br />

10346 Pervivo Preparat ziołowy Oral solution Bittner Richard GmbH 30/04/04<br />

10347 Peryndopryl Perindoprilum Tablets 4 mg MARCPHARM S.p. z.o.o. 31/12/08<br />

10348 Peryndopryl Anpharm Perindoprilum<br />

erbuminum<br />

Tablets 4 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

14/02/07<br />

10349 Perystavit Bional Pharma BV 31/12/08<br />

10350 Pestikal B1 Szczepionka przeciw,<br />

rzekomemu pomorowi<br />

drobiu dla kurczat,<br />

kur, niosek i indyków<br />

10351 Pestikal La Sota Szczepionka przeciw,<br />

rzekomemu pomorowi<br />

drobiu dla kurcza˛t,<br />

kur, niosek, indyków<br />

10352 Pestikal+EDS+IB Inaktywowana<br />

szczepionka dla kur<br />

przeciw rzekomemu<br />

pomorowi drobiu,<br />

syndromowi spadku<br />

nies´nos´ci, zakaz´nemu<br />

zapaleniu skrzeli<br />

10353 Pestos Szczepionka przeciw<br />

rzekomemu pomorowi<br />

drobiu dla kur,<br />

indyków i perliczek<br />

10354 PETASITES comp. cum Quercu<br />

gran.<br />

10355 PETASITES comp. cum Veronica<br />

gran.<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Pliva 11/02/04<br />

Pliva 11/02/04<br />

Pliva d.d 2/01/06<br />

Merial 30/06/04<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

10356 Petinimid Ethosuximidum Capsules 250 mg Gerot Pharmazeutika GmbH 31/07/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1195<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10357 Petroleum D-2, D-3, D-4 Kosmed II, Głubczyce 26/02/06<br />

10358 Petroleum D5 Asa, Głubczyce 30/05/06<br />

10359 Petroleum D-5 ANNA, Nowa De˛ba 28/02/05<br />

10360 Petroleum D-5 Kosmed II, Głubczyce 28/02/05<br />

10361 Petylyl Desipraminum Coated tablets 25 mg AWD.pharma GmbH & Co.<br />

KG<br />

31/07/04<br />

10362 Pevaryl Lipogel Econazolum Gel 10 mg/g Cilag AG 31/07/04<br />

10363 Pevaryl P.V. Econazolum Shampoo 10 mg/g Cilag AG 30/06/04<br />

10364 Pevazol Econazolum Cream 10 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

10365 Pevisone Econazolum +<br />

Triamcinolonum<br />

10366 Pevisone Econazolum +<br />

Triamcinolonum<br />

Cream (10mg +<br />

1,1mg)/g<br />

Ointment (10mg +<br />

1,1mg)/g<br />

10367 PG 600 Gonadotropinum Lyophilisate for veterinary<br />

use<br />

10368 PGF Veyx forte Kloprostenol Solution for veterinary<br />

use<br />

6/06/07<br />

Cilag AG 30/06/04<br />

Cilag AG 31/05/04<br />

Intervet 31/12/07<br />

Veyx Pharma 31/12/08<br />

10369 Phapax Drops Lehning Laboratoires 31/03/06<br />

10370 Pharmalgen Hymenoptera<br />

Venoms<br />

Alergeny jadów<br />

błonoskrzydłych<br />

Lyophilisate for<br />

solution for<br />

subcutaneous<br />

injection<br />

10371 Pharmasin 200 Tylozyna Solution for veterinary<br />

use<br />

10372 Pharmasin 50 Tylozyna Solution for veterinary<br />

use<br />

10373 Pharmasin pulvis Tylozyny winian Powder for veterinary<br />

use<br />

Alk-Abello A/S 31/03/04<br />

Antibiotic Co 14/06/04<br />

Antibiotic Co 30/06/04<br />

Antibiotic Co 14/06/04<br />

10374 Pharmatex Benzalkonii chloridum Vaginal capsule 18,9 mg Laboratoire Innotech<br />

International<br />

10375 Pharmaton Film-coated tablets Boehringer Ingelheim<br />

International GmbH<br />

10376 Phaseolus similiaplex krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

10377 Phenazolinum Antazolinum Solution for injection 50 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10378 Phenyl — Free 1 Odz˙ywka Powder for oral<br />

solution<br />

Mead Johnson Nutritionals a<br />

Bristol Myers Squibb<br />

Company<br />

10379 Phenyl Free 2 Dieta w fenyloketonurii Powder Mead Johnson Nutritionals A<br />

Bristol-Myers Squibb<br />

10380 Phenyl Free 2 HP Dieta w fenyloketonurii Powder Mead Johnson Nutritionals A<br />

Bristol-Myers Squibb<br />

10381 Phenyl-Free Dieta w fenyloketonurii Powder Mead Johnson Nutritional<br />

Group<br />

31/12/08<br />

17/01/07<br />

30/11/05<br />

30/11/05<br />

31/12/08<br />

10/05/06<br />

10/05/06<br />

30/04/05


EN<br />

1196 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10382 Phenytoinum Phenytoinum Tablets 100 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/11/05<br />

10383 Phlebodia® Diosminum Film-coated tablets 600 mg Laboratoire INNOTHERA 31/12/08<br />

10384 Phloderm Hamamelis cortex<br />

extractum spissum<br />

Ointment 30 mg/g Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

30/04/05<br />

10385 phono Chol Phonix 31/12/05<br />

10386 phono Chol Phonix 31/12/05<br />

10387 phono Gripp Phonix 31/12/05<br />

10388 phono Uren Phonix 31/12/05<br />

10389 phono Ven Phonix 31/12/05<br />

10390 Phospho-Laxative Natrii phosphas + Natrii<br />

phosphas (32P)<br />

Enema R & C — Przedsie˛biorstwo<br />

Farmaceutyczne s.c.<br />

30/10/05<br />

10391 Phosphor Preparat złoz˙ony Granules 350 mg fosforu Herbapol Łódz´ S.A. 31/01/06<br />

10392 Phosphor-Homaccord Amp. Heel GmbH 31/12/08<br />

10393 Phosphor-Homaccord Drops Heel GmbH 31/12/08<br />

10394 Phostal Alergeny grzybów<br />

ples´niowych,<br />

dermatofitów i droz˙dz˙y<br />

Suspension for<br />

subcutaneous<br />

injection<br />

10395 Phostal Alergeny pyłków ros´lin Suspension for<br />

subcutaneous<br />

injection<br />

10396 Phostal Alergeny pyłków ros´lin Suspension for<br />

subcutaneous<br />

injection<br />

10397 Phostal Alergeny roztoczy kurzu<br />

domowego<br />

Suspension for<br />

subcutaneous<br />

injection<br />

10398 Phostal Alergeny siers´ci zwierza˛t Suspension for<br />

subcutaneous<br />

injection<br />

10399 Photofrin Porfimer sodium Powder for solution<br />

for intravascular<br />

injection<br />

10400 Photofrin Porfimer sodium Powder for solution<br />

for intravascular<br />

injection<br />

10401 Physiodose Natrii chloridi 0.9 %<br />

FP V<br />

Stallergenes S.A. 31/08/05<br />

Stallergenes S.A. 31/08/05<br />

Stallergenes S.A. 31/08/05<br />

Stallergenes S.A. 31/08/05<br />

Stallergenes S.A. 31/08/05<br />

15 mg Axcan Pharma Inetrnational<br />

B.V.<br />

75 mg Axcan Pharma Inetrnational<br />

B.V.<br />

5/07/06<br />

5/07/06<br />

Liquid Laboratoires Gilbert 19/04/07<br />

10402 Physiotens 0,2 Moxonidinum Film-coated tablets 0,2 mg Solvay Pharmaceuticals<br />

GmbH<br />

10403 Physiotens 0,3 Moxonidinum Film-coated tablets 0,3 mg Solvay Pharmaceuticals<br />

GmbH<br />

10404 Physiotens 0,4 Moxonidinum Film-coated tablets 0,4 mg Solvay Pharmaceuticals<br />

GmbH<br />

10405 Physostigminum salicylicum Physostigminum Solution for injection 0.5 mg/1 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10406 Phytodolor N Preparat ziołowy Oral drops Steigerwald Arzneimittelwerk<br />

GmbH<br />

31/03/04<br />

31/03/04<br />

31/03/04<br />

30/11/05<br />

24/08/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1197<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10407 Phytolacca-Dagomed 24 bóle<br />

gardła, chrypka<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/01/06<br />

10408 Phytotux Ipeca complexe Syrup Lehning Laboratoires 4/01/05<br />

10409 Piascledine 300 Preparat złoz˙ony Capsules Laboratoires Pharmascience 31/12/08<br />

10410 Pigmentum Castellani Coutanous liquid Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

31/01/06<br />

10412 Pikovit Buccal tablet Krka d.d., Novo mesto 31/07/04<br />

10411 Pikovit Syrup Krka d.d., Novo mesto 31/07/04<br />

10413 Pikovit Forte Preparat złoz˙ony Film-coated tablets KRKA d.d., Novo mesto 31/12/08<br />

10414 Pillkan 20 Megesirolu octan Medicated candy for veterinary<br />

use<br />

10415 Pillkan 5 Megesirolu octan Medicated candy for veterinary<br />

use<br />

Ceva Sante Animale 30/06/04<br />

Ceva Sante Animale 30/06/04<br />

10416 Pilocarpinum 2 % Pilocarpinum Eye drops, solution 20 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10417 Pilocarpinum 3 % HEC Pilocarpinum Eye drops, solution 30 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10418 Pilocarpinum ophtalm 2 % Pilocarpinum Eye ointment 20 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

31/03/07<br />

31/01/05<br />

10419 Pilogel Pilocarpinum Eye gel 40 mg/g Alcon Laboratoires Inc Texas 30/04/04<br />

10420 Pilokarpiny chlorowodorek A.C.E.F., Włochy 31/12/08<br />

10421 Pilokarpiny chlorowodorek BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08<br />

10422 Pilokarpiny chlorowodorek Farm-Impex s.j., Gliwice 31/12/08<br />

10423 Pilokarpiny chlorowodorek Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

10424 Pilokarpiny chlorowodorek Pharma Cosmetic, Kraków 31/12/08<br />

10425 Pilokarpiny chlorowodorek Pharma Zentrale 31/12/08<br />

10426 Pilokarpiny chlorowodorek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

10427 Pilomann 2 % Pilocarpinum Eye drops 20 mg/ml Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

10428 Piloxidil Minoxidilum Coutanous liquid 20 mg/ml Dr Włodzimierz Zgoda<br />

Chemical Research,<br />

Consulting, Production<br />

31/12/08<br />

31/07/04<br />

31/12/05<br />

10429 Pimafucin Natamycinum Coated tablets 100 mg Yamanouchi Europe B.V. 31/07/04<br />

10431 Pimafucin Natamycinum Cream 20 mg/g Yamanouchi Europe B.V. 31/07/04<br />

10432 Pimafucin Natamycinum Oral drops 25 mg/ml Yamanouchi Europe B.V. 31/07/04<br />

10430 Pimafucin Natamycinum Pessary 100mg Yamanouchi Europe N.V 31/07/04<br />

10434 Pimafucort Hydrocortisonum +<br />

Natamycinum +<br />

Neomycinum<br />

Cream (10mg + 10mg<br />

+ 1750 IU)/ g<br />

Yamanouchi Europe B.V. 31/07/04


EN<br />

1198 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10433 Pimafucort Hydrocortisonum +<br />

Natamycinum +<br />

Neomycinum<br />

10435 Pimafucort Hydrocortisonum +<br />

Natamycinum +<br />

Neomycinum<br />

Cutaneous emulsion (10mg + 5mg<br />

+ 3500 IU)/ g<br />

Ointment (10mg + 10mg<br />

+ 3500 IU) /g<br />

Yamanouchi Europe B.V. 31/07/04<br />

Yamanouchi Europe B.V. 31/07/04<br />

10436 Pini Syrup Herbapol — Lublin S.A. 31/12/08<br />

10437 Pini Forte Syrup Herbapol — Lublin S.A. 31/12/08<br />

10438 Pini gemmae Herb Z.K.Z. FLOS, Mokrsko 31/12/08<br />

10439 PiniHelix Syrup 101.9 mg/<br />

5ml<br />

10440 Pinimentol Inhalation vapour,<br />

solution<br />

10441 Pinnacle IN szczepionka do<br />

czynnego<br />

uodparniania<br />

zdrowych koni i<br />

z´rebia˛t przeciwko tzw.<br />

zołzom<br />

Lyophilisate for veterinary<br />

use<br />

10442 Pinorubin Pirarubicinum Powder for solution<br />

for intravenous<br />

injection<br />

10443 Pinorubin Pirarubicinum Powder for solution<br />

for intravenous<br />

injection<br />

Apipol — Farma Sp. z o.o.<br />

Przedsie˛biorstwo Pszczelarsko<br />

— Farmaceutyczne<br />

27/06/07<br />

Apotheca Pacis 31/03/05<br />

Fort Dodge 31/12/08<br />

10 mg Mercian Corporation 30/11/04<br />

20 mg Mercian Corporation 30/11/04<br />

10444 Pinosol Nasal cream Slovakofarma a.s. 31/10/04<br />

10445 Pinosol Nasal drops Slovakofarma a.s. 31/10/04<br />

10446 Pinosol Nasal ointment Slovakofarma a.s. 31/10/04<br />

10447 Piogen Pioglitazonum Tablets 15 mg GENEXO Sp.z.o.o Warszawa 31/12/08<br />

10448 Pioktanina BUFA b.v. Pharmaceutical<br />

Products<br />

24/09/05<br />

10449 Pioktanina El Virus, Siemianowice 24/09/05<br />

10450 Pioktanina Pharma Cosmetic, Kraków 24/09/05<br />

10451 Pioktanina Pharma Zentrale 24/09/05<br />

10452 Pioktanina PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

10453 Pioktanina 3 % — roztwór<br />

spirytusowy<br />

10454 Pioktanina roztwór etanolowy<br />

1%<br />

Pyoctaninum<br />

coeruleum<br />

Methylrosanilinii<br />

chloridum<br />

10455 Pioktisol Methylrosanilinii<br />

chloridum<br />

Solution for veterinary<br />

use<br />

10456 Piperacillin Piperacillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

24/09/05<br />

Galvet 31/12/08<br />

Coutanous liquid 10 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Coutanous liquid 10 mg/g Cefarm Gdańsk<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

2 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

27/03/06<br />

31/01/06<br />

30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1199<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10457 Piperacillin Piperacillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

10458 Pipril Piperacillinum Lyophilisate for<br />

solution for<br />

intravenous and<br />

intramuscular<br />

injection<br />

10459 Pipril Piperacillinum Lyophilisate for<br />

solution for<br />

intravenous and<br />

intramuscular<br />

injection and for<br />

intravenous infusion<br />

1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/10/05<br />

2 g Wyeth-Lederle Pharma GmbH 30/04/04<br />

4 g Wyeth-Lederle Pharma GmbH 30/04/04<br />

10460 Pirogalol Pharma Zentrale 14/01/05<br />

10463 Pirolam Ciclopiroxum Gel 1 % Medana Pharma Terpol<br />

Group S.A.<br />

10461 Pirolam Ciclopiroxum Solution 1 % Medana Pharma Terpol<br />

Group S.A.<br />

10462 Pirolam Ciclopiroxum Suspension 1 % Medana Pharma Terpol<br />

Group S.A.<br />

10465 Piroxicam Piroxicamum Film-coated tablets 10 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

10466 Piroxicam Piroxicamum Film-coated tablets 20 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

10467 Piroxicam Piroxicamum Gel 50 mg/g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

10464 Piroxicam Piroxicamum Ointment 50 mg/g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

10468 Piroxicam 10 Piroxicamum Suppository 10 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

10469 Piroxicam 20 Piroxicamum Suppository 20 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

10470 Pivalone Neomycine Tixocortoloni pivalas +<br />

Neomycinum<br />

10471 Pivalone Neomycine Tixocortoloni pivalas +<br />

Neomycinum<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

30/11/05<br />

30/11/05<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

Nasal suspension Jouveinal Laboratories 31/12/08<br />

Sinus suspension Jouveinal Laboratories 31/12/08<br />

10472 Pivepol Dipivefrinum Eye drops 0.1 % Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

10473 Placenta compositum Amp. Heel GmbH 31/12/07<br />

10474 Planate Kloprostenol Solution for veterinary<br />

use<br />

10475 Plantagen Plantaginis herba<br />

extractum fluidum<br />

Schering-Plough Central East<br />

AG<br />

Syrup 12 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

15/01/06<br />

31/12/08<br />

10476 Plantaginis lanceolatae folium Herb Z.K.Z. FLOS, Mokrsko 31/12/08<br />

10477 Plantagis Syrup 324 mg/5 ml Microfarm s.c.<br />

Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

30/10/05<br />

10478 Plantago Ointment WALA-Heilmittel GmbH 24/05/07<br />

10479 Plantago Syrup WALA-Heilmittel GmbH 24/05/07


EN<br />

1200 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10480 Plantago-Homaccord Amp. Heel GmbH 31/12/07<br />

10481 Plantago-Homaccord Drops Heel GmbH 31/12/07<br />

10482 Plantagolax Herbal granules Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

10483 Plantex — herbata dla<br />

niemowla˛t i dzieci<br />

Granules for oral<br />

solution<br />

30/10/05<br />

476 mg/5g Lek Pharmaceuticals d.d. 30/04/04<br />

10484 Plantifort Preparat ziołowy Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

10485 Plasmasteril Hydroxyethylamylum Solution for<br />

intravenous infusion<br />

60 mg/ml Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

31/12/08<br />

31/07/04<br />

10486 Plaster na odciski Acidum salicylicum Pach Perfecta — Spółdzielnia Pracy 23/09/07<br />

10487 Plaster nostrzykowy PPF GEMI, Karczew 20/02/07<br />

10488 Plaster rozgrzewaja˛cy ABC Pach 11 mg<br />

kapsaicynoidów<br />

10489 Platamine Cisplatinum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

10490 Platamine Cisplatinum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

Beiersdorf AG 31/12/04<br />

10 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

50 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

30/06/04<br />

30/06/04<br />

10491 Platidiam Cisplatinum Injection 10 mg/20 ml PLIVA — Lachema a.s. 26/09/07<br />

10492 Platidiam Cisplatinum Injection 25 mg/50 ml PLIVA — Lachema a.s. 26/09/07<br />

10493 Platidiam Cisplatinum Injection 50 mg/100 ml PLIVA — Lachema a.s. 26/09/07<br />

10494 Platidiam Cisplatinum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

10495 Platidiam Cisplatinum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

10496 Platidiam Cisplatinum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

10 mg PLIVA — LACHEMA a.s. 31/05/04<br />

25 mg PLIVA — LACHEMA a.s. 31/05/04<br />

50 mg PLIVA — LACHEMA a.s. 31/05/04<br />

10497 Platinex Cisplatinum Solution for injection 0.5 mg/ml Bristol-Myers Squibb S.p.A,<br />

Latina<br />

11/12/05<br />

10498 Plavix Clopidogrelum Film-coated tablets 75 mg Sanofi Pharma BMS SNC 30/04/04<br />

10499 Plendil Felodipinum Film-coated tablets 10 mg AstraZeneca AB 30/04/05<br />

10500 Plendil Felodipinum Film-coated tablets 5 mg AstraZeneca AB 30/04/05<br />

10501 Pleuro — suivax Szczepionka dla s´wiń<br />

przeciwko<br />

pleuropneumonii<br />

Suspension for veterinary<br />

use<br />

Fatro Włochy 31/12/08<br />

10502 Plexxo 100 Lamotriginum Tablets 100 mg Desitin Pharma Sp. z o.o. 6/06/07<br />

10503 Plexxo 25 Lamotriginum Tablets 25 mg Desitin Pharma Sp. z o.o. 6/06/07<br />

10504 Plexxo 50 Lamotriginum Tablets 50 mg Desitin Pharma Sp. z o.o. 6/06/07<br />

10505 Plicet Paracetamolum Syrup 120 mg/5ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

23/11/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1201<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10506 Plidocain Lidocainum Solution for injection 10 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10507 Plidocain Lidocainum Solution for injection 20 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10509 Plimycol Clotrimazolum Coutanous liquid 10 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10508 Plimycol Clotrimazolum Cream 10 mg/g Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10510 Plimycol Clotrimazolum Vaginal tablets 200 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10511 Plivasept foaming Chlorhexidinum Liquid 4.5 % Pliva Farmaceutical, Chemical,<br />

Food and Cosmetic Industry<br />

Inc.<br />

10512 Plivosept 2,4-dichlorobenzyl<br />

alcohol +<br />

Amylmethacresolum<br />

10513 Plixym Cefuroximum Powder for solution<br />

for intravascular<br />

injection and for<br />

suspension for<br />

intramuscular<br />

injection<br />

10514 Plixym Cefuroximum Powder for solution<br />

for intravascular<br />

injection and infusion<br />

10515 Plixym Cefuroximum Powder for<br />

suspension for<br />

intramuscular<br />

injection and solution<br />

for inravenous<br />

injection<br />

10516 Plofed 1 % Propofolum Emulsion for<br />

intravenous injection<br />

Buccal tablets 1,2mg +0,6mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

750 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

1.5 g Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

250 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10517 Plusssz Junior Effervescent tablets Pharmavit/Bristol-Myers<br />

Squibb<br />

10518 Plusssz Multiwitamina Effervescent tablets Pharmavit/Bristol-Myers<br />

Squibb<br />

10519 Plusssz Witamina C Acidum ascorbicum<br />

(vit C) + Riboflavinum<br />

(vit B2)<br />

Effervescent tablets 75 mg Pharmavit/Bristol-Myers<br />

Squibb<br />

10520 Płyn Burowa Aflofarm Farmacja Polska,<br />

Pabianice<br />

27/09/06<br />

27/09/06<br />

31/05/05<br />

31/05/05<br />

30/04/05<br />

31/12/04<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

6/07/05<br />

30/01/05<br />

30/01/05<br />

30/01/05<br />

31/12/08<br />

10521 Płyn Burowa Cefarm Szczecin 31/12/08<br />

10522 Płyn Burowa Hasco-Lek, Wrocław 31/12/08<br />

10523 Płyn Burowa Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

10524 Płyn do dializy otrzewnowej<br />

nr 1<br />

10525 Płyn do dializy otrzewnowej<br />

nr 2<br />

Solution for<br />

peritoneum dialysis<br />

Solution for<br />

peritoneum dialysis<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/01/06<br />

31/01/06


EN<br />

1202 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10526 Płyn do dializy otrzewnowej<br />

nr 3<br />

Solution for<br />

peritoneum dialysis<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/06<br />

10527 Płyn do jamy ustnej Liquid WALA-Heilmittel GmbH 24/05/07<br />

10528 Płyn Fizjologiczny<br />

Wieloelektrolitowy Izotoniczny<br />

10529 Płyn Fizjologiczny<br />

Wieloelektrolitowy Izotoniczny<br />

10530 Płyn Fizjologiczny<br />

Wieloelektrolitowy Izotoniczny<br />

10531 Płyn Fizjologiczny<br />

Wieloelektrolitowy Izotoniczny<br />

10532 Płyn Jelitowy Zapobiegawczy<br />

Izotoniczny<br />

10533 Płyn Jelitowy Zapobiegawczy<br />

Izotoniczny<br />

Chlorek sodu, Chlorek<br />

potasu, Chlorek<br />

wapnia, Chlorek<br />

magnezu, Octan sodu,<br />

Cytrynian sodu<br />

Kalii chloridum + Natrii<br />

acetas + Natrii<br />

chloridum<br />

Kalii chloridum + Natrii<br />

acetas + Natrii<br />

chloridum<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

Solution for veterinary<br />

use<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

(0,45mg +<br />

6,8mg +<br />

5,5mg)/ml<br />

Fresenius Kabi Polska Sp. z<br />

o.o.<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/06<br />

31/01/06<br />

Baxter Terpol Sp. z o.o. 31/01/06<br />

Fresenius Kabi Polska 31/12/08<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/06<br />

Baxter Terpol Sp. z o.o. 31/01/06<br />

10534 Płyn na odciski Aflofarm Farmacja Polska,<br />

Pabianice<br />

10535 Płyn na odciski Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

31/12/08<br />

31/12/08<br />

10536 Płyn na odciski Labpharm-ATS, Brwinów 31/12/08<br />

10537 Płyn na odciski Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

10538 Płyn na odciski -Radix Acidum lacticum +<br />

Acidum salicylicum<br />

Coutanous liquid Maggie — Laboratorium<br />

Farmaceutyczno-Kosmetyczne<br />

31/12/08<br />

31/01/06<br />

10539 PŁYN NA OPARZENIA Liquid WALA-Heilmittel GmbH 24/05/07<br />

10540 Płyn nawadniajacy<br />

interwencyjny hipotoniczny<br />

10541 Płyn nawadniajacy<br />

interwencyjny hipotoniczny<br />

10542 Płyn pediatryczny<br />

wyrównawczy<br />

10543 Płyn pediatryczny<br />

wyrównawczy<br />

10544 Płyn przeciw pchłom dla<br />

kotów<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/06<br />

Baxter Terpol Sp. z o.o. 31/01/06<br />

Preparat złoz˙ony Liquid for infusion Fresenius Kabi Polska Sp. z<br />

o.o.<br />

Solution for<br />

intravenous infusion<br />

Diazinon Liquid for veterinary<br />

use<br />

10545 Płyn przeciw pchłom dla psów Diazinon Liquid for veterinary<br />

use<br />

10546 Płyn wieloelektrolitowy Sodu chlorek, , Potasu<br />

chlorek, Wapnia<br />

chlorek, Magnezu<br />

chlorek, Sodu octan,<br />

Sodu cytrynian<br />

Solution for veterinary<br />

use<br />

10547 Płyn wyrównawczy Solution for<br />

intravenous infusion<br />

31/01/06<br />

Baxter Terpol Sp. z o.o. 31/01/06<br />

Beaphar 26/04/04<br />

Beaphar 26/04/04<br />

Lubelskie Zakłady<br />

Farmaceutyczne ‘Polfa’ Spółka<br />

Akcyjna<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

19/12/06<br />

31/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1203<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10548 Płyn z˙oła˛dkowy<br />

zapobiegawczy izotoniczny<br />

10549 Płyn z˙oła˛dkowy<br />

zapobiegawczy izotoniczny<br />

Ammonii chloridum +<br />

Kalii chloridum + Natrii<br />

chloridum<br />

Ammonii chloridum +<br />

Kalii chloridum + Natrii<br />

chloridum<br />

10550 Pm — Olvac szczepionka dla kur i<br />

indyków przeciwko<br />

pomorowi rzekomemu<br />

drobiu i cholerze<br />

drobiu<br />

10551 PM-VAC Szczepionka przeciw<br />

paramyksowirusowej<br />

chorobie gołe˛bi<br />

10552 Pneumabort K+1b Szczepionka przeciw<br />

zakaz˙eniom układu<br />

oddechowego u koni i<br />

wirusowemu ronieniu<br />

klaczy<br />

10553 Pneumo 23 Pneumococcus, purified<br />

polysaccharides antigen<br />

10554 Pneumodog Szczepionka przeciw<br />

zakaz˙eniom układu<br />

oddechowego psów<br />

Solution for<br />

intravenous infusion<br />

Solution for<br />

intravenous infusion<br />

(3,74mg +<br />

1,27mg +<br />

3,68mg)/ml<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Solution for<br />

intramuscular and<br />

subcutaneous<br />

injection<br />

Suspension for veterinary<br />

use<br />

Lubelskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/06<br />

Baxter Terpol Sp. z o.o. 31/01/06<br />

Fatro 31/12/08<br />

Biowet Puławy 21/06/04<br />

Fort Dodge 31/12/08<br />

0.5 ml Aventis Pasteur S.A. 31/12/08<br />

Merial 14/06/04<br />

10555 Pneumodoron 1 krople WELEDA 24/08/05<br />

10556 Pneumodoron 2 krople WELEDA 24/08/05<br />

10557 Pneumosuis III Szczepionka przeciw<br />

pleuropneumonii dla<br />

s´wiń<br />

10558 Pneumovax 23 Vaccinum pneumococcale<br />

polysaccharidicum<br />

10559 Pnu-Imune 23 Solution for<br />

subcutaneous and<br />

intramuscular<br />

injection<br />

10560 Po46 (Kloracef) Cefaclorum Film-coated,<br />

prolonged release<br />

tablets<br />

Suspension for veterinary<br />

use<br />

Pfizer 20/08/04<br />

Solution for injection 0.5 ml Merck Sharp & Dohme Idea<br />

Inc.<br />

2/12/06<br />

Wyeth-Lederle Pharma GmbH 17/01/07<br />

375 mg Bioton Sp. z o.o. 31/12/08<br />

10561 Podofilina A.C.E.F., Włochy 31/12/08<br />

10562 Podofilina Pharma Cosmetic, Kraków 31/12/08<br />

10563 Podophyllum compositum Amp. Heel GmbH 31/12/07<br />

10564 Podophyllum compositum Drops Heel GmbH 31/12/07<br />

10565 Podtlenek azotu Gas Zach-Ciech Sp. z o.o. 31/12/07<br />

10566 Podtlenek azotu Gas Linde Gas Ungarn AG 31/12/07<br />

10567 Podtlenek azotu Medical gas Messer Polska Sp. z o.o. 31/12/07<br />

10568 Podtlenek azotu N2O Medical gas AGA Gaz Sp. z o.o. 31/12/08


EN<br />

1204 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10569 Pojedyncze leki<br />

homeopatyczne w potencjach<br />

decymalnych i centymalnych<br />

wg listy<br />

10570 Pojedyncze preparaty<br />

homeopatyczne (67<br />

preparatów)<br />

10571 Pojedyncze preparaty homeopatyczne<br />

(lista)<br />

10572 Pojedyncze preparaty<br />

homeopatyczne potencje 1DH<br />

do 30CH<br />

10573 Pojedyncze preparaty<br />

homeopatyczne potencje<br />

30 CH — 200 CH; 6 K —<br />

10 MK<br />

10574 Pojedyncze preparaty<br />

homeopatyczne TM<br />

10575 Pojedyncze preparaty homeopatyczne: A. Causticum, A. Muriaticum, H. Lava, L.<br />

Operculata, T. cubenis, Thymuline, T. Persicolor, T. rubrum w potencjach TM do<br />

200CH i 6K do 10MK<br />

10576 Pojedyncze preparaty<br />

homeopatyczne: potencje 2C<br />

do 200C i 6K do CMK<br />

10577 Polbicillinum Benzylpenicillinum<br />

procainicum +<br />

Benzatylpenicillinum<br />

kalicum<br />

Granules Jelinowski<br />

Lab.Homeopatyczne, Syców<br />

31/08/07<br />

Lehning Laboratoires 31/10/05<br />

Decymal, Gdańsk 31/12/08<br />

Laboratoires BOIRON 31/12/08<br />

Laboratoires BOIRON 9/01/06<br />

Drops Laboratoires BOIRON 31/12/08<br />

Dry substance for<br />

solution for injection<br />

for veterinary<br />

use<br />

Laboratoires BOIRON 31/12/08<br />

Dolisos Laboratoires 31/12/08<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne Polfa<br />

10578 Polcortolon Triamcinolonum Tablets 1 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

10579 Polcortolon Triamcinolonum Tablets 4 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

10580 Polcortolon 0,1 % Triamcinolonum Cream 1 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

10581 Polcortolon 0,1 % Triamcinolonum Ointment 1 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

10582 Polcortolon 40 Triamcinolonum Suspension for<br />

injection<br />

10583 Polcortolon TC Tetracyclinum +<br />

Triamcinolonum<br />

Cutaneous spray 13,79mg +<br />

0,34mg)/ml<br />

40 mg/1 ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10584 Polcrom Acidum cromoglicicum Eye drops, solution 20 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10585 Polcrom 2 % Natrii cromoglicas Nasal spray, solution 20 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10586 Poldanen Pygeum africanum Capsuels, hard 30 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

10587 Poldanen Pygeum africanum Film-coated tablets 46 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

10588 Poldest Benzathini<br />

benzaylpenicillinum +<br />

Dihydrostreptomycinum<br />

Suspension for veterinary<br />

use<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

31/12/08<br />

31/12/05<br />

31/12/05<br />

31/01/06<br />

31/01/06<br />

30/11/05<br />

31/05/05<br />

30/04/05<br />

31/12/08<br />

30/04/05<br />

30/10/05<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1205<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10589 Poldomet 100 Carbidopum +<br />

Levodopum<br />

10590 Poldomet 250 Carbidopum +<br />

Levodopum<br />

10591 POLDOMET Prolongatum 125 Levodopum +<br />

Carbidopum<br />

10592 POLDOMET Prolongatum 250 Levodopum +<br />

Carbidopum<br />

Tablets 25mg +<br />

100mg<br />

Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

Prolonged release<br />

tablets<br />

Prolonged release<br />

tablets<br />

100 mg +<br />

25 mg<br />

200 mg +<br />

50 mg<br />

Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10593 Polfenon Propafenonum Film-coated tablets 150 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10594 Polfenon Propafenonum Film-coated tablets 300 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

21/10/06<br />

21/10/06<br />

31/12/08<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

10595 Polfergan Promethazinum Syrup 5 mg/5ml Polfarmex S.A 31/12/05<br />

10596 Polfilin Pentoxifyllinum Concentrate for<br />

solution for infusion<br />

300 mg/15 ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10598 Polfilin Pentoxifyllinum Film-coated tablets 100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10597 Polfilin Pentoxifyllinum Solution for injection 100 mg/5 ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10599 Polfilin prolongatum Pentoxifyllinum Prolonged release<br />

tablets<br />

10600 Polfungicid Acidum salicylicum +<br />

Chlormidazolum<br />

Coutanous liquid (50mg +<br />

10mg)/ml<br />

400 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/12/08<br />

31/01/06<br />

31/12/08<br />

31/01/06<br />

ICN Polfa Rzeszów S.A. 31/12/05<br />

10601 Polfungicid Chlormidazolum Medicated powder 50 mg/g ICN Polfa Rzeszów S.A. 31/12/05<br />

10602 Polhumin Insulinum isophanum<br />

humanum<br />

10603 Polhumin L Insulini zinci suspensio<br />

humani<br />

10604 Polhumin L Insulini zinci suspensio<br />

humani<br />

10605 Polhumin Mix — 3 Insulinum humanum +<br />

Insulinum isophanum<br />

humanum<br />

10606 Polhumin Mix — 3 Insulinum humanum +<br />

Insulinum isophanum<br />

humanum<br />

10607 Polhumin Mix-3 Insulinum humanum,<br />

Insulinum isophanum<br />

humanum<br />

10608 Polhumin N Insulinum isophanum<br />

humanum<br />

10609 Polhumin N Insulinum isophanum<br />

humanum<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

100 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

40 j.m/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

100 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

40 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

100 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

100 j.m. / ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

40 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

100 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10610 Polhumin R Insulinum humanum Solution for injection 40 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10611 Polhumin R Insulinum humanum Solution for injection 100 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

1206 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10612 Polhumin R Insulinum humanum Suspension for<br />

subcutaneous,<br />

intramuscular and<br />

intravenous injection<br />

100 j.m./ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

10613 Polibar Acb Barii sulfas Powder E — Z — EM Inc. 31/12/08<br />

10614 POLIO — ROS — szczepionka<br />

przeciw kleszczowemu<br />

zapaleniu mózgu<br />

10615 POLIO — ROS — szczepionka<br />

przeciw kleszczowemu<br />

zapaleniu mózgu<br />

10616 POLIO — ROS — szczepionka<br />

przeciw kleszczowemu<br />

zapaleniu mózgu<br />

10617 Polio Sabin — Oral Szczepionka przeciwko<br />

Poliomyelitis<br />

10618 Polio Sabin — Oral Szczepionka przeciwko<br />

Poliomyelitis<br />

10619 Polio Sabin — Oral Szczepionka przeciwko<br />

Poliomyelitis<br />

10620 Polio Sabin — Oral Szczepionka przeciwko<br />

Poliomyelitis<br />

10621 Polio Sabin — Oral Szczepionka przeciwko<br />

Poliomyelitis<br />

10622 Polio-Sabin oral Poliomyelitis, trivalent,<br />

inactivated, whole virus<br />

10623 Polisacharydowa szczepionka<br />

meningokokowa A+C<br />

10624 Polisacharydowa szczepionka<br />

meningokokowa A+C<br />

Meningococcus A,<br />

purified polysaccharides<br />

antigen<br />

Meningococcus A,<br />

purified polysaccharides<br />

antigen<br />

10625 Polisepsin Surowica<br />

odpornos´ciowa<br />

przeciw zakaz˙eniom<br />

wywołanym przez<br />

Pasteurella multocida<br />

Oral suspension szczepionka 10<br />

— dawkowa<br />

Oral suspension szczepionka 25<br />

— dawkowa<br />

Oral suspension szczepionka 50<br />

— dawkowa<br />

Oral suspension szczepionka 1<br />

dawkowa ×<br />

1,2550 i 100<br />

fiolek<br />

plastikowych<br />

Oral suspension szczepionka 20<br />

dawkowa ×<br />

1,2550 i 100<br />

fiolek<br />

plastikowych<br />

Oral suspension szczepionka 25<br />

dawkowa ×<br />

1,2550 i 100<br />

fiolek<br />

plastikowych<br />

Oral suspension szczepionka 50<br />

— dawkowa ×<br />

1,2550 i 100<br />

fiolek<br />

szklanych<br />

Oral suspension szczepionka<br />

100 dawkowa<br />

× 1,2550 i 100<br />

dawek<br />

szklanych<br />

Instytut Poliomyelitis i<br />

Wirusowego Zapalenia<br />

Mózgu Rosyjskiej Akademii<br />

Nauk Medycznych<br />

Instytut Poliomyelitis i<br />

Wirusowego Zapalenia<br />

Mózgu Rosyjskiej Akademii<br />

Nauk Medycznych<br />

Instytut Poliomyelitis i<br />

Wirusowego Zapalenia<br />

Mózgu Rosyjskiej Akademii<br />

Nauk Medycznych<br />

SmithKline Beecham<br />

Biologicals<br />

SmithKline Beecham<br />

Biologicals<br />

SmithKline Beecham<br />

Biologicals<br />

SmithKline Beecham<br />

Biologicals<br />

SmithKline Beecham<br />

Biologicals<br />

Oral suspension SmithKline Beecham<br />

Biologicals<br />

Lyophilisate for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

Lyophilisate for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

0.5 ml<br />

(1 dawka)<br />

5ml<br />

(10 dawek)<br />

Liquid for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

29/02/04<br />

Aventis Pasteur S.A. 31/12/08<br />

Aventis Pasteur S.A. 31/12/08<br />

Drwalewskie Zakłady Przem.<br />

Biowet<br />

24/05/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1207<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10626 Polisulfalent Sulfadimetoksyna,<br />

Sulfatiazol,<br />

Sulfadimidyna<br />

10627 Polisulfamid Sulfametazyna<br />

sodowa, Sulfatiazol<br />

sodowy, Sulfacetamid<br />

sodowy<br />

10628 Polityphovac Inaktywowana<br />

szczepionka przeciw<br />

salmonelozie bydła,<br />

s´wiń, lisów i nutrii<br />

10629 Pollinex Alergeny pyłków ros´lin Suspension for<br />

subcutaneous<br />

injection<br />

10630 Pollinex + Rye Alergeny pyłków ros´lin Suspension for<br />

injection<br />

10631 Pollinex Tree Alergeny pyłków ros´lin Suspension for<br />

injection<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Biowet Puławy 26/04/04<br />

Biowet Puławy 24/05/04<br />

Zakłady Farm. Biowet 25/05/04<br />

Allergy Therapeutics Limited 31/03/04<br />

Allergy Therapeutics Limited 9/10/06<br />

Allergy Therapeutics Limited 6/11/06<br />

10632 Pol-Mag Magnesii hydroaspartas powder for solution 360.6 mg/g Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10633 Polmantis Magnesii hydroxidum +<br />

Alumini hydroxidum<br />

Buccal tablets 200 mg +<br />

200 mg<br />

30/10/05<br />

POLON Sp. z o.o. 31/12/08<br />

10634 Polmesilat Pridinolum Tablets 4.18 mg Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp. z<br />

o.o.<br />

31/01/06<br />

10635 Polmonte Montelukastum Chewable tablets 4 mg Merck Sharp & Dohme B.V. 31/12/08<br />

10637 Polmonte Montelukastum Chewable tablets 5 mg Merck Sharp & Dohme B.V. 31/12/08<br />

10636 Polmonte Montelukastum Film-coated tablets 10 mg Merck Sharp & Dohme B.V. 31/12/08<br />

10638 Polnitrin Glyceroli trinitras Muco-adhesive buccal<br />

tablets<br />

10639 Polocainum Hydrochloricum<br />

2 % cum Adrenalino 0,005 %<br />

10640 Polocainum Hydrochloricum<br />

5 % cum Adrenalino 0,005 %<br />

10641 POLOCALCIUM O Smaku<br />

Truskawkowym<br />

10642 POLOCALCIUM O Smaku<br />

Ananasowym<br />

10643 POLOCALCIUM O Smaku<br />

Jez˙ynowym<br />

10644 POLOCALCIUM O Smaku<br />

Wis´niowym<br />

Polokainy<br />

chlorowodorek,<br />

Adrenalina<br />

Polokainy<br />

chlorowodorek,<br />

Adrenalina<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Preparat złoz˙ony Syrup 114 mg Ca2 +<br />

50 j.m. D3/5ml<br />

Preparat złoz˙ony Syrup 114 mg Ca2+,<br />

50 j.m. D3/5ml<br />

Preparat złoz˙ony Syrup 114 mg Ca2+,<br />

50 j.m. D3/5ml<br />

Preparat złoz˙ony Syrup 114 mg Ca2+,<br />

50 j.m. D3/5ml<br />

10645 Polodina-R Povidone-iodine Solution for external<br />

use<br />

5 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

Drwalewskie Zakłady<br />

Przemysłu Biowet.<br />

30/06/06<br />

28/04/04<br />

28/04/04<br />

Polfarmex Sp. z o.o. 31/12/08<br />

Polfarmex Sp. z o.o. 31/12/08<br />

Polfarmex Sp. z o.o. 31/12/08<br />

Polfarmex Sp. z o.o. 31/12/08<br />

100 mg/g Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp. z<br />

o.o.<br />

10646 Polomigran Pizotifenum Tablets 500 mcg Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp. z<br />

o.o.<br />

31/03/06<br />

31/01/06


EN<br />

1208 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10647 Polopiryna Acidum acetylsalicylicum Gastro-resistant<br />

tablets<br />

10648 Polopiryna C Acidum acetylsalicylicum<br />

+ Acidum ascorbicum<br />

(vit C)<br />

10649 Polopiryna Cardio Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

10650 Polopiryna Cardio Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

0.5 g Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

Effervescent tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

0.15 g Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

75 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10651 Polopiryna S Acidum acetylsalicylicum Tablets 300 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

30/10/05<br />

31/12/07<br />

31/12/07<br />

31/01/06<br />

10652 Polovital C Acidum ascorbicum Effervescent tablets 500 mg Polfarmex S.A. 31/12/08<br />

10653 Polovital C Acidum ascorbicum Effervescent tablets 1000 mg Polfarmex S.A. 31/12/08<br />

10654 Polprazol Omeprazolum Capsules 10 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10655 Polprazol Omeprazolum Capsules 20 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10656 Polpressin Prazosinum Tablets 1 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10657 Polpressin Prazosinum Tablets 2 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10658 Polpressin Prazosinum Tablets 5 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10659 Polsen Zolpidemum Film-coated tablets 10 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

10661 Polseptol Povidone-iodine Ointment 100 mg/g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

10660 Polseptol Povidone-iodine Pessary 200mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

10662 Polspiron Spironolactonum Tablets 25 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10663 Polstatin Pravastatinum Tablets 20 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

10664 Polstatin Pravastatinum Tablets 10 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

10665 Polstigminum Neostigminum Solution for injection 0.5 mg/1 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10666 Polstigminum Neostigminum Tablets 15 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10667 Polsukralt Sucralfatum Oral suspension 1 g/5 ml Spółdzielnia Pracy<br />

Chemiczno —<br />

Farmaceutycznej ‘POLON’<br />

10668 Poltaxel Paclitaxelum Solution for injection 6 mg/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10669 Poltit Pharmacia & Upjohn<br />

Allergon AB<br />

10671 Poltram Tramadolum Capsules 50 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

9/08/06<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

31/01/06<br />

31/12/05<br />

30/09/05<br />

31/12/08<br />

31/12/08<br />

30/11/05<br />

30/11/05<br />

31/12/08<br />

25/10/06<br />

31/12/08<br />

30/09/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1209<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10672 Poltram Tramadolum Drops 100 mg/ml Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10670 Poltram Tramadolum Suppository 100 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10673 Poltram Tramadolum Tablets for oral<br />

solution<br />

100 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10674 Poltram 100 Tramadolum Solution for injection 100 mg/2 ml Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10675 Poltram 50 Tramadolum Solution for injection 50 mg/ml Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10676 Poltram 50 Tramadolum Tablets 50 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

10677 Poltram Retard 100 Tramadolum Prolonged release<br />

tablets<br />

10678 Poltram Retard 150 Tramadolum Prolonged release<br />

tablets<br />

10679 Poltram Retard 200 Tramadolum Prolonged release<br />

tablets<br />

100 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

150 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

200 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

30/09/07<br />

30/09/07<br />

30/09/07<br />

30/09/07<br />

30/09/07<br />

30/09/07<br />

30/09/07<br />

30/09/07<br />

30/09/07<br />

10680 Polvir Denotivirum Cream 0.03 g/g ICN Polfa Rzeszów S.A. 30/10/05<br />

10681 Polvir Denotivirum Cutanous stick 120 mg ICN Polfa Rzeszów S.A. 30/10/05<br />

10682 Polypenject Amoxicillunum Suspension for veterinary<br />

use<br />

Dopharma 18/08/04<br />

10683 Polytar AF Antidandruff Stiefel Laboratories Ltd. 31/12/08<br />

10684 Polytar Liquid Antidandruff Stiefel Laboratories Ltd. 31/12/08<br />

10685 Polyvaccinum forte Szczepionka wielowaz˙na<br />

bakteryjna<br />

10686 Polyvaccinum mitte Szczepionka wielowazna<br />

bakteryjna<br />

10687 Polyvaccinum mitte Szczepionka wielowazna<br />

bakteryjna<br />

10688 Polyvaccinum submite Szczepionka wielowazna<br />

bakteryjna<br />

10689 Polyverkan Oksybendazol,<br />

Niklozamid<br />

10690 Polzomycyna Oleandomycinum +<br />

Tetracicllinum<br />

Suspension for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

Nasal suspension Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

Suspension for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

Suspension for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

Sugar cube for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

Ceva Sante Animale 8/01/07<br />

Biowet Gorzów 31/12/08<br />

10691 Populus Compositum SR Drops Heel GmbH 31/12/08<br />

10692 Porcilis APP Szczepionka dla s´wiń<br />

przeciw<br />

pleuropneumonii<br />

Suspension for veterinary<br />

use<br />

Intervet 12/01/06


EN<br />

1210 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10693 Porcilis AR-T Szczepionka przeciw<br />

zakaz´nemu<br />

zanikowemu zapaleniu<br />

nosa u s´wiń ,<br />

10694 Porcilis Aujeszky Szczepionka przeciw<br />

chorobie Aujeszkyego<br />

10695 Porcilis Begonia Szczepionka przeciw<br />

chorobie Aujeszkyego<br />

10696 Porcilis BPM szczepionka do<br />

uodparniania s´wiń, w<br />

celu zapobiegania<br />

zapaleniu płuc i<br />

schorzenim dróg<br />

oddechowych<br />

10697 Porcilis Coli Szczepionka przeciw<br />

kolibakteriozie prosia˛t<br />

10698 Porcilis Ery Szczepionka przeciw<br />

róz˙ycy s´wiń<br />

10699 Porcilis Ery + Parvo Szczepionka przeciw<br />

róz˙ycy i<br />

parwowirusowej<br />

chorobie s´wiń<br />

10700 Porcilis M Inaktywowana<br />

szczepionka przeciw<br />

enzootycznej<br />

bronchopneumonii<br />

s´wiń<br />

10701 Porcilis Parvo Szczepionka przeciw<br />

parwowirozie s´wiń<br />

10702 Porcilis PRRS Szczepionka przeciw<br />

zespołowi rozrodczooddechowemu<br />

s´wiń<br />

10703 Porcilis Strepsuis szczepionka dla<br />

prosia˛t przeciwko<br />

zakaz˙eniom<br />

streptococcus suis<br />

Emulsion for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Intervet 31/12/08<br />

Intervet 10/03/04<br />

Intervet 31/12/07<br />

Intervet International 31/12/08<br />

Intervet 31/12/07<br />

Intervet 31/12/08<br />

Intervet 17/06/07<br />

Intervet Inc. 3/04/05<br />

Intervet 31/12/07<br />

Intervet International B.V. 14/08/05<br />

Intervet International 31/12/08<br />

10704 Porost islandzki Herbalux, Warszawa 14/05/07<br />

10705 Porost islandzki Herbapol Białystok 14/05/07<br />

10706 Porost islandzki Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

10707 Porost islandzki Zioła Lecznicze Boguccy,<br />

Kraków<br />

10708 Porost islandzki 1 Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

10709 Portagen Preparat odz˙ywczy z<br />

MCT<br />

Powder for solution Mead Johnson b.v. a Bristol<br />

Myers Squibb Company<br />

10710 Posorutin Troxerutinum Eye drops 50 mg/ml Ursapharm Arzneimittel<br />

GmbH& CoKG<br />

10712 Posterisan Inaktywowane E. coli Rectal ointment Dr Kade Pharmazeutische<br />

Fabrik GmbH<br />

10711 Posterisan Inaktywowane E. coli Suppository Dr Kade Pharmazeutische<br />

Fabrik GmbH<br />

14/05/07<br />

14/05/07<br />

31/12/05<br />

30/06/04<br />

31/12/07<br />

30/06/04<br />

30/06/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1211<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10714 Posterisan H Inaktywowane E. coli +<br />

Hydrocortisonum<br />

10713 Posterisan H Inaktywowane E. coli +<br />

Hydrocortisonum<br />

Rectal ointment Dr Kade Pharmazeutische<br />

Fabrik GmbH<br />

Suppository Dr Kade Pharmazeutische<br />

Fabrik GmbH<br />

30/06/04<br />

30/06/04<br />

10715 Postinor Levonorgestrelum Tablets 750 mcg Gedeon Richter Ltd. 31/12/08<br />

10716 Potacitrin Acidum citricum + Kalii<br />

citras<br />

10717 Potacitrin Cytrynian potasu<br />

jednowodny 220 mg,<br />

Kwas cytrynowy<br />

jednowodny 66.8 mg<br />

Syrup Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Syrup 220 mg +<br />

66,8 mg<br />

25/01/06<br />

Farmacom Sp. z o.o. 25/01/06<br />

10718 Potasu azotan BUFA b.v. Pharmaceutical<br />

Products<br />

31/03/05<br />

10719 Potasu azotan Pharma Cosmetic, Kraków 31/03/05<br />

10720 Potasu azotan Pharma Zentrale 31/03/05<br />

10721 Potasu azotan PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/03/05<br />

10722 Potasu bromek A.C.E.F., Włochy 31/12/08<br />

10723 Potasu bromek BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08<br />

10724 Potasu bromek Pharma Cosmetic, Kraków 31/12/08<br />

10725 Potasu bromek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

10726 Potasu bromek Przedsie˛biorstwo Chmiczne<br />

Odczynniki Sp. z o.o., Lublin<br />

31/12/08<br />

31/12/08<br />

10727 Potasu chlorek Biochem, Warszawa 30/11/05<br />

10728 Potasu chlorek Pharma Cosmetic, Kraków 30/11/05<br />

10729 Potasu chlorek Pharma Zentrale 30/11/05<br />

10730 Potasu chlorek Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

10731 Potasu chlorek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

30/11/05<br />

30/11/05<br />

10732 Potasu jodek El Virus, Siemianowice 31/12/08<br />

10733 Potasu jodek Farm-Impex s.j., Gliwice 31/12/08<br />

10734 Potasu jodek Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

31/12/08<br />

10735 Potasu jodek Pampa, Piaseczno 31/12/08<br />

10736 Potasu jodek Pharma Cosmetic, Kraków 31/12/08<br />

10737 Potasu jodek Pharma Zentrale 31/12/08<br />

10738 Potasu jodek Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

10739 Potasu jodek Przedsie˛biorstwo Chmiczne<br />

Odczynniki Sp. z o.o., Lublin<br />

31/12/08<br />

31/12/08<br />

10740 Potasu nadmanganian El Virus, Siemianowice 31/12/08


EN<br />

1212 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10741 Potasu nadmanganian Hasco-Lek, Wrocław 31/12/08<br />

10742 Potasu nadmanganian Maga-Herba s.c., Legionowo 31/12/08<br />

10743 Potasu nadmanganian Pharma Cosmetic, Kraków 31/12/08<br />

10744 Potasu nadmanganian Pharma Zentrale 31/12/08<br />

10745 Potasu nadmanganian Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

10746 Potasu nadmanganian PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

10747 Potasu nadmanganian Przedsie˛biorstwo Chmiczne<br />

Odczynniki Sp. z o.o., Lublin<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

10748 Potasu n-admanganian Lefarm, Bydgoszcz 31/12/08<br />

10749 Potasu siarczan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

10750 Potasu we˛glan Margo Corporation,<br />

Warszawa<br />

31/07/05<br />

31/12/08<br />

10751 Potasu we˛glan Pharma Zentrale 31/12/08<br />

10752 Potasu we˛glan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

31/12/08<br />

10753 Potasu wodorowe˛glan Pharma Zentrale 24/01/05<br />

10754 Potasu wodorowe˛glan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

10755 Potencil Amoxicillunum +<br />

Colistinum<br />

10756 Poulvac AE Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

mózgu i rdzenia dla<br />

kur<br />

10757 Poulvac Bursa Plus Z˙ywa szczepionka dla<br />

kur przeciw<br />

zakaz´nemu zapaleniu<br />

torby Fabrycjusza<br />

10758 Poulvac Bursine 2 Szczepionka przeciw<br />

chorobie Gumboro dla<br />

kur<br />

10759 Poulvac Chick V.A. szczepionka do<br />

uodparniania kurcza˛t<br />

przeciwko zapaleniu<br />

stawów wywołanemu<br />

przez reowirusy ptasie<br />

10760 Poulvac IB Primer Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli dla kur<br />

10761 Poulvac i-EDS Szczepionka przeciw<br />

syndromowi spadku<br />

nies´nos´ci<br />

Suspension for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

24/01/05<br />

Virbac 25/08/04<br />

Fort Dodge 30/06/04<br />

Fort Dodge Animal Health 22/11/06<br />

Fort Dodge 30/01/05<br />

Fort Dodge 31/12/08<br />

Fort Dodge 30/01/05<br />

Fort Dodge 3/09/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1213<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10762 Poulvac i-INE Inaktywowana<br />

szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu oskrzeli,<br />

rzekomemu pomorowi<br />

drobiu i syndromowi<br />

spadku nies´nos´ci<br />

10763 Poulvac ILT szczepionka do<br />

uodparniania kurcza˛t<br />

przeciwko zakaz´nemu<br />

zapaleniu krtani i<br />

tchawicy<br />

10764 Poulvac Marek CVI szczepionka do<br />

uodparniania kurcza˛t<br />

przeciwko chorobie<br />

mareka<br />

10765 Poulvac Marek CVI+HVT Z˙ywa szczepionka dla<br />

kur przeciw chorobie<br />

Mareka<br />

10766 Poulvac Marek HVT Szczepionka przeciw<br />

chorobie Mareka<br />

10767 Poulvac Marek HVT/CA Z˙ywa szczepionka dla<br />

kur przeciw chorobie<br />

Mareka<br />

10768 Poulvac ND LaSota Szczepionka przeciw<br />

rzekomemu pomorowi<br />

drobiu dla kur i<br />

indyków<br />

10769 Poulvac NDW Szczepionka dla kur i<br />

indyków przeciw<br />

rzekomemu pomorowi<br />

drobiu<br />

10770 Poulvac Past M Szczepionka przeciw<br />

pasterelozie drobiu dla<br />

kur, indyków i kaczek<br />

10771 Poulvac Tri Reo Szczepionka<br />

inaktywowana dla<br />

kurcza˛t przeciw<br />

reowirusowemu<br />

zapaleniu stawów i<br />

pochewek<br />

s´cie˛gnowych,<br />

zespołowi złego<br />

wchłaniania oraz<br />

zespołowi martwicy<br />

główki kos´ci udowej i<br />

kruchych kos´ci.<br />

10772 Poulvac TRT Szczepionka dla kur i<br />

indyków przeciw<br />

zakaz˙eniom<br />

wywołanym przez<br />

pneumowirusy ptasie.<br />

10773 Poxvac K Szczepionka przeciw<br />

ospie kur i gołe˛bi<br />

Emulsion for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension + solvent for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Suspension + solvent for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Water — oil emulsion for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

10774 Pparamectin Pasta Iwermektyna Paste for veterinary<br />

use<br />

Fort Dodge Animal Health 14/11/06<br />

Fort Dodge 31/12/08<br />

Fort Dodge 31/12/08<br />

Fort Dodge Animal Health 22/11/06<br />

Fort Dodge Animal Health 19/01/04<br />

Fort Dodge Animal Health 22/11/06<br />

Fort Dodge 30/01/05<br />

Fort Dodge 31/08/05<br />

Fort Dodge 31/08/05<br />

Fort Dodge Animal Health 3/11/05<br />

Fort Dodge Animal Health<br />

B.V.<br />

17/07/05<br />

Biowet Puławy 24/05/04<br />

Norbrook 31/12/08<br />

10775 Pramidin 10 Metoclopramidum Nasal spray, solution 200 mg/ml Crinos Industria<br />

Farmacobiologica S.p.A<br />

10/05/06


EN<br />

1214 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10776 Pramidin 20 Metoclopramidum Nasal spray, solution 400 mg/ml Crinos Industria<br />

Farmacobiologica S.p.A<br />

10777 Pramolan Opipramolum Coated tablets 50 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10778 Pratel Prazikwantel,<br />

Pyrantelu embonian<br />

Tablet for veterinary<br />

use<br />

10779 Pravastatin Pravastatinum Tablets 10 mg, 20 mg,<br />

40 mg<br />

Lek Pharmaceutical and<br />

Chemical Company<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

10780 Prawastin Pravastatinum Film-coated tablets 10 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

10781 Prawastin Pravastatinum Film-coated tablets 20 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

10782 Prazinon Praziquantelum Solution for veterinary<br />

use<br />

10/05/06<br />

31/01/06<br />

10/02/04<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Veterina 31/12/08<br />

10783 Prazol Omeprazolum Capsules 10 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

10784 Prazol Omeprazolum Capsules 20 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

10785 Precedex Dexmedetomidinum Concantrate for<br />

solution for<br />

intravenous infusion<br />

14/02/07<br />

31/12/08<br />

100 mcg/ml Abbott Laboratories 25/10/06<br />

10786 Prednicarbat Prednicarbatum Cream 0,10 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

10787 Prednicarbat Prednicarbatum Cream 0,25 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

10788 Prednicarbat Prednicarbatum Ointment 0,10 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

10789 Prednicarbat Prednicarbatum Ointment 0,25 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

10790 Prednisolonum Prednisolonum Cream 2.5 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

10791 Prednisolonum 0,5 % Prednisolonum Eye drops, suspension 5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

30/11/05<br />

30/10/05<br />

10792 Prednizolon Pharma Cosmetic, Kraków 28/02/05<br />

10793 Prednizolon Pharma Zentrale 28/02/05<br />

10794 Prednizolon Polfa Pabianice 28/02/05<br />

10795 Prednizolon PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

28/02/05<br />

10797 Preductal Trimetazidinum Film-coated tablets 20 mg Les Laboratoires Servier 30/01/05<br />

10796 Preductal Trimetazidinum Oral drops 20 mg/ml Les Laboratoires Servier 30/01/05<br />

10798 Preductal MR Trimetazidinum Film-coated, modified<br />

release tablets<br />

10799 Pregestimil Dieta eliminacyjna z<br />

MCT<br />

35 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Powder for solution Mead Johnson b.v. a Bristol<br />

Myers Squibb Company<br />

23/11/05<br />

30/06/04<br />

10800 Pregnacare Preparat złoz˙ony Capsules Vitabiotics Ltd. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1215<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10801 Pregnavit Capsules, soft Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

10802 Pregnyl Gonadotrophinum<br />

chorionicum<br />

10803 Pregnyl Gonadotrophinum<br />

chorionicum<br />

10804 Pregnyl Gonadotrophinum<br />

chorionicum<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

1500 j.m. Organon N.V. —<br />

Kloosterstraat<br />

500 j.m. Organon N.V. —<br />

Kloosterstraat<br />

5000 j.m. Organon N.V. —<br />

Kloosterstraat<br />

31/12/08<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

10805 Premarin Estrogena coniugata Film-coated tablets 0.625 mg Wyeth-Lederle Pharma GmbH 31/12/08<br />

10806 Premarin Estrogena coniugata Film-coated tablets 1.25 mg Wyeth-Lederle Pharma GmbH 31/12/08<br />

10807 Premella 2,5 Estrogena coniugata +<br />

Medroxyprogesteronum<br />

10808 Premella 5 Estrogena coniugata +<br />

Medroxyprogesteronum<br />

10809 Premens® Agni casti extractum<br />

siccum<br />

Film-coated tablets Wyeth-Lederle Pharma GmbH 30/11/04<br />

Film-coated tablets Wyeth-Lederle Pharma GmbH 30/11/04<br />

Film-coated tablets 40 mg EWOPHARMA AG 31/12/08<br />

10810 Prenatal Film-coated tablets Puritan's Pride, Incorporated 31/12/08<br />

10811 Prenix Perindoprilum +<br />

Indapamidum<br />

10812 Prenix Forte Perindoprilum +<br />

Indapamidum<br />

Tablets 2 mg +<br />

0,625 mg<br />

Tablets 4 mg +<br />

1,25 mg<br />

Przedsie˛biorstwo<br />

Farmaceutyczne Anpharm<br />

S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne Anpharm<br />

S.A.<br />

10814 Preparation H Saccharomyces boulardii Ointment Wyeth-Lederle Pharma GmbH<br />

Division Whitehall<br />

10813 Preparation H Saccharomyces boulardii Suppository Wyeth-Lederle Pharma GmbH<br />

Division Whitehall<br />

10815 Preparation H z˙el Hamamelidis aqua Rectal gel 500 mg/g Wyeth-Lederle Pharma GmbH<br />

Division Whitehall<br />

10816 Preparaty homeopatyczne typu<br />

Injeel — 1187 preparatów<br />

10817 Preparaty homeopatyczne wg<br />

listy na odwrocie<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

29/11/06<br />

Heel GmbH 28/02/05<br />

Heel GmbH 31/12/08<br />

10818 Prepidil Dinoprostonum Vaginal gel 0.5 mg/3 g Pharmacia N.V./S.A. 30/06/04<br />

10819 Presdopril Perindoprilum Tablets 4 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

10820 Pressocard Labetalolum Film-coated tablets 0.1 g Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10821 Pressocard Labetalolum Film-coated tablets 0.2 g Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

10822 PRESSURAL Sugare Coated<br />

Tabletki<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

Indapamidum Polifarma S.p.A. 31/12/08<br />

10823 Prestarium Perindoprilum Tablets 4 mg Les Laboratoires Servier 30/06/04


EN<br />

1216 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10824 Prevenar Suspension for<br />

injection<br />

1 dawka<br />

(0,5 ml)<br />

10825 Preventic Amitrazum Collar for veterinary<br />

use<br />

10826 Prewenit Acidum folicum,<br />

Cyanocobalaminum,<br />

Pyridoxinum<br />

Tablets 800 µg + 4 µg<br />

+4mg<br />

10827 Prezerwer Nonoxinolum Liquid 80 mg/g Adamed Sp. z o.o.<br />

Laboratorium<br />

Farmaceutyczne<br />

M.Adamkiewicz<br />

Wyeth-Lederle Pharma GmbH 21/06/06<br />

Virbac 25/08/04<br />

P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

10828 Pridinol Pridinolum Tablets 5 mg Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp.<br />

z o.o.<br />

10829 Primacor Lercanidipini<br />

hydrochloridum<br />

10830 PRIMADEX 20 Retard Isosorbidi mononitras Prolonged release<br />

tablets<br />

10831 PRIMADEX 40 Retard Isosorbidi mononitras Prolonged release<br />

tablets<br />

10832 PRIMADEX 60 Retard Isosorbidi mononitras Prolonged release<br />

tablets<br />

Film-coated tablets 10 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

20 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

40 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

60 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10833 Prime again Preparat złoz˙ony Capsules, soft Sunrider Manufacturing L.P.,<br />

USA<br />

10834 Primene 5 % Solution for<br />

intravenous infusion<br />

10835 Primene 10 % Solution for<br />

intravenous infusion<br />

10836 Primiza Paracetamolum +<br />

Tramadolum<br />

10837 Primodog Szczepionka przeciw<br />

parwowirusowej<br />

chorobie psów<br />

Tablets 37,5 mg +<br />

325 mg<br />

Liquid for veterinary<br />

use<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

31/12/05<br />

31/01/06<br />

14/02/07<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/07/04<br />

31/07/04<br />

Cilag AG 31/12/08<br />

Merial 2/03/05<br />

10838 Primolut-Nor Norethisteronum Tablets 5 mg Schering AG 31/07/04<br />

10839 Primucell FIP Szczepionka przeciw<br />

zakaz´nemu zapaleniu<br />

otrzewnej kotów<br />

Lyophilisate for veterinary<br />

use<br />

Pfizer 31/12/07<br />

10840 Prinivil Lisinoprilum Tablets 10 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10841 Prinivil Lisinoprilum Tablets 20 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10842 Prinivil Lisinoprilum Tablets 5 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10843 Priorix Morbilli, combinations<br />

with parotitis and<br />

rubella, live attenuated<br />

Lyophilisate and<br />

solvent for solution<br />

for subcutaneous and<br />

intramuscular<br />

injection<br />

1 dawka SmithKline Beecham Pharma<br />

GmbH<br />

10844 Pritor Telmisartanum Tablets 40 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

30/04/05<br />

30/04/05<br />

30/04/05<br />

30/04/05<br />

31/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1217<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10845 Pritor Telmisartanum Tablets 80 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

10846 Pritor Telmisartanum Tablets 20 mg Glaxo Wellcome House,<br />

Glaxo Wellcome Group<br />

10847 Pritor Plus Telmisartanum +<br />

Hydrochlorothiazidum<br />

10848 Pritor Plus Telmisartanum +<br />

Hydrochlorothiazidum<br />

10849 Proacid Aluminii glycinas +<br />

Magnesii carbonas<br />

10850 Probitor Omeprazolum Gastro-resistant<br />

capsules, hard<br />

Tablets 40 mg +<br />

12,5 mg<br />

Tablets 80 mg +<br />

12,5 mg<br />

Tablets 450mg +<br />

50mg<br />

Glaxo Wellcome House,<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House,<br />

Glaxo Wellcome Group<br />

Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

31/01/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

20 mg Biochemie GmbH 31/12/08<br />

10851 Procainamidum Procainamidum Tablets 250 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

10852 Procard Crataegi flos cum folium<br />

extractum siccum<br />

10853 Procomvax Vaccinum haemophili<br />

stripe b conjugatum et<br />

Vaccinum hepatitidis B<br />

[ADNr]<br />

Film-coated tablets 135 mg Europlant Phytopharm, Sp. z<br />

o.o., Kle˛ka<br />

Suspension for<br />

intramuscular<br />

injection<br />

0.5 ml Merck Sharp & Dohme Idea<br />

Inc.<br />

10854 Procortin Hydrocortisoni butyras Cream 1 mg/g Homeofarm Sp. z o.o.<br />

Laboratorium<br />

Farmaceutyczne<br />

10855 Procortin Lipocrem Hydrocortisoni butyras Cream 1 mg/g Homeofarm Sp. z o.o.<br />

Laboratorium<br />

Farmaceutyczne<br />

31/12/05<br />

31/12/08<br />

30/06/05<br />

15/11/06<br />

15/11/06<br />

10856 Proctheel Drops Heel GmbH 31/12/08<br />

10858 Procto-Glyvenol Lidocainum +<br />

Tribenosidum<br />

10857 Procto-Glyvenol Lidocainum +<br />

Tribenosidum<br />

10859 Proctohemolan Tribenozydum +<br />

Lidocainum<br />

Rectal cream Novartis Consumer Health<br />

S.A.<br />

Suppository Novartis Consumer Health<br />

S.A.<br />

Cream (5 g+2,12 g)/<br />

100 g<br />

Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

31/07/04<br />

31/07/04<br />

31/12/08<br />

10861 Proctosone Rectal ointment Polmex Sp. z o.o. 31/05/05<br />

10860 Proctosone Suppository Polmex Sp. z o.o. 31/05/05<br />

10862 Pro-Efferalgan Propacetamolum Powder for solution<br />

for infusion<br />

10863 Profasi Gonadotrophinum<br />

chorionicum<br />

10864 Profasi Gonadotrophinum<br />

chorionicum<br />

10865 Profasi Gonadotrophinum<br />

chorionicum<br />

Lyophilisate and<br />

solvent for solution<br />

for subcutaneous or<br />

intramuscular<br />

injection<br />

Lyophilisate and<br />

solvent for solution<br />

for subcutaneous or<br />

intramuscular<br />

injection<br />

Lyophilisate and<br />

solvent for solution<br />

for subcutaneous or<br />

intramuscular<br />

injection<br />

1 g UPSA Laboratoires Agen 30/06/07<br />

10000 j.m. Laboratoires Serono S.A. 31/01/05<br />

2000 j.m. Laboratoires Serono S.A. 31/01/05<br />

5000 j.m. Laboratoires Serono S.A. 31/01/05


EN<br />

1218 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10867 Profenid Ketoprofenum Capsules 50 mg Rhône-Poulenc Rorer Specia 30/06/04<br />

10872 Profenid Ketoprofenum Film-coated tablets 100 mg Rhône-Poulenc Rorer Specia 31/12/08<br />

10873 Profenid Ketoprofenum Gel 25 mg/g Rhône-Poulenc Rorer Specia 30/06/04<br />

10868 Profenid Ketoprofenum Lyophilisate and<br />

solvent for solution<br />

for intramuscular<br />

injection<br />

10870 Profenid Ketoprofenum Lyophilisated<br />

substance for solution<br />

for intravascular<br />

infusion<br />

10871 Profenid Ketoprofenum Prolonged release<br />

tablets<br />

100 mg Rhône-Poulenc Rorer Specia 30/06/04<br />

100 mg Rhône-Poulenc Rorer Specia 31/12/08<br />

200 mg Rhône-Poulenc Rorer Specia 31/12/08<br />

10869 Profenid Ketoprofenum Solution for injection 50 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/11/05<br />

10866 Profenid Ketoprofenum Suppository 100 mg Rhône-Poulenc Rorer Specia 31/05/04<br />

10874 Profenid prolongatum Ketoprofenum Prolonged release<br />

tablets<br />

200 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

10875 Profenorm Propafenonum Film-coated tablets 150 mg PRO. MED. C.S., Praha a.s. 31/12/08<br />

10876 Proficar Acidum acetylsalicylicum Gastro-resistant<br />

tablets<br />

10877 Profilac Ioderm Powidon jodu, Glicerol Liquid for veterinary<br />

use<br />

10878 Profilac Iopre Powidon jodu,<br />

Glicerol,<br />

10879 Profilac Protec Powidon jodu,<br />

Glicerol, Alantoina<br />

Liquid for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

75 mg Polfarmex S.A 29/06/05<br />

FinkTec GmbH 21/01/07<br />

FinkTec GmbH 21/01/07<br />

FinkTec GmbH 21/01/07<br />

10880 Progesteronum Progesteronum Solution for injection 25 mg/1 ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

10881 Prograf Tacrolimus Amp. 5 mg/ml Fujisawa 30/11/04<br />

10882 Prograf Tacrolimus Capsules 0,5 mg Fujisawa 30/11/04<br />

10883 Prograf Tacrolimus Capsules 1 mg Fujisawa 30/11/04<br />

10884 Prograf Tacrolimus Capsules 5 mg Fujisawa 30/11/04<br />

10885 Prograf Tacrolimus Capsules 1 mg Fujisawa GmbH 30/11/04<br />

10886 Prograf Tacrolimus Capsules 5 mg Fujisawa GmbH 30/11/04<br />

10887 Prograf Tacrolimus Concantrate for<br />

solution for<br />

intravenous infusion<br />

10888 Progressis Szczepionka<br />

przeciwko zakaz˙eniom<br />

wirusem Zespołu<br />

Rozrodczo-<br />

Oddechowego s´wiń<br />

Emulsion for veterinary<br />

use<br />

5 mg/ml Fujisawa GmbH 30/11/04<br />

Merial 31/12/08<br />

10889 Progynon C Ethinylestradiolum Tablets 20 mcg Schering AG 11/08/05<br />

10890 Progynova 21 mite Estradiolum Film-coated tablets 1 mg Schering AG 30/11/04<br />

10891 Progynova-21 Estradiolum Film-coated tablets 2 mg Schering AG 30/11/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1219<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10892 ProHance Gadoteridolum Solution for<br />

intravenous injection<br />

279.3 mg/ml Bracco-Byk Gulden 6/07/05<br />

10893 Prokainy chlorowodorek Galenus, Warszawa 9/07/07<br />

10894 Prokainy chlorowodorek Pharma Cosmetic, Kraków 9/07/07<br />

10895 Prokainy chlorowodorek Pharma Zentrale 9/07/07<br />

10896 Prokainy chlorowodorek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

10897 Proktosanol Mas´ć przeciw<br />

hemoroidom<br />

10898 Prolaxatan Macrogolum Powder for oral<br />

solution<br />

10899 Prolaxatan o smaku<br />

cytrynowym<br />

10900 Prolaxatan o smaku<br />

jabłkowym<br />

Macrogolum Powder for oral<br />

solution<br />

Macrogolum Powder for oral<br />

solution<br />

10901 Proleukin Aldesleukinum Lyophilisate for<br />

solution for injection<br />

or for intravenous<br />

infusion<br />

9/07/07<br />

Pampa, Piaseczno 14/10/06<br />

10 g Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

10 g Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

10 g Polfa Łódz´ S.A. Zakłady<br />

Farmaceutyczne<br />

18 mln. j.m.<br />

(1mg)<br />

9/08/06<br />

9/08/06<br />

9/08/06<br />

Chiron B.V. 30/06/04<br />

10902 Prolipid Capsuels, hard P.T. Indofarma 30/11/04<br />

10903 Proluton Depot Hydroxyprogesteroni<br />

caproas<br />

Solution for<br />

intravenous injection<br />

250 mg/ml Schering AG 31/03/05<br />

10904 Promazin Promazinum Coated tablets 100 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

10905 Promazin Promazinum Coated tablets 25 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

10906 Promazin Promazinum Coated tablets 50 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

10907 Promazin Promazinum Solution for injection 50 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

10908 Promedol Trimeperidinum Solution for injection 20 mg/ml Zdrowie Narodu 31/12/08<br />

10909 Promethazine Promethazinum Syrup 5 mg/5 ml Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

10910 Pro-miss Coffeinum +<br />

Mepyraminum +<br />

Paracetamolum<br />

10911 Promit Dekstranum Solution for<br />

intravenous injection<br />

10912 Promon Vet Medroxyprogesteronum Tablet for veterinary<br />

use<br />

10913 Promote (o smaku<br />

waniliowym)<br />

31/12/08<br />

Film-coated tablets Kato LABS Sp. z o.o. 25/05/05<br />

150 mg/ml Medisan (Mayrhofer<br />

Pharmazeutica GmbH, A)<br />

31/12/08<br />

Pharmacia N.V./S.A. 10/02/04<br />

Preparat odz˙ywczy Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

10914 Promycine Pulvis 4800 Collistinum Powder for veterinary<br />

use<br />

10915 Pronoran Piribedilum Prolonged release<br />

tablets<br />

10916 Prontobario Colon Barii sulfas Powder for rectal<br />

suspension<br />

30/06/07<br />

V.M.D. 31/12/08<br />

50 mg Les Laboratoires Servier 23/11/05<br />

940.15 mg/g Bracco S.p.A. 31/01/05


EN<br />

1220 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10917 Prontobario HD Barii sulfas Powder for oral<br />

suspension<br />

10918 Prontoket Ketoprofenum Cutaneous spray,<br />

solution<br />

10919 Prontopyrin Plus Paracetamolum +<br />

Coffeinum<br />

Tablets 400 mg +<br />

50 mg<br />

984.5 mg/g Bracco S.p.A. 31/01/05<br />

50 mg/g Medicom International s.r.o. 4/07/07<br />

Heinrich Mack Nachf. GmbH<br />

& Co. KG<br />

10920 Propecia Finasteridum Film-coated tablets 1 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

10921 Propess Dinoprostonum Rectal insert<br />

(transdermal system)<br />

10922 Propisderm Glukonian<br />

chlorheksydyny<br />

10mg (5mg/<br />

12h)<br />

Liquid for veterinary<br />

use<br />

10923 Propofol 1 % Fresenius Propofolum Emulsion for injection<br />

or intravenous<br />

infusion<br />

10925 Propolan Cutaneous and<br />

mucosa membrane<br />

liquid<br />

10 % (0,01 g/<br />

1 ml)<br />

Controlled Therapeutics<br />

(Scotland) Ltd<br />

31/12/08<br />

31/12/04<br />

14/02/07<br />

Hypred 31/12/08<br />

Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

33 mg/ml Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

10924 Propolan Ointment 40 mg/g Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

10928 Propolis Cutaneous and<br />

mucosa ligiud<br />

10929 Propolis Cutaneous and<br />

mucosa membrane<br />

liquid<br />

25 mg/ml Apipol — Farma Sp. z o.o.<br />

Przedsie˛biorstwo Pszczelarsko<br />

— Farmaceutyczne<br />

25 mg/ml Apipol — Farma Sp. z o.o.<br />

Przedsie˛biorstwo Pszczelarsko<br />

— Farmaceutyczne<br />

31/01/05<br />

30/10/05<br />

30/10/05<br />

31/05/06<br />

31/05/06<br />

10926 Propolis Drops 3 % Farmatel Gdańsk 31/12/07<br />

10927 Propolis Ointment 3 % Farmatel Gdańsk 31/12/07<br />

10930 Propolis forte Propolis extractum Tablets Przedsiebiorstwo<br />

Pszczelarsko-Farmaceutyczne<br />

‘APIPOL-FARMA’ Sp. z o.o.,<br />

Mys´lenice<br />

10931 Propolis -krople z kitu<br />

pszczelego<br />

Cutaneous and<br />

mucosa membrane<br />

liquid<br />

31/12/08<br />

26 mg/ml Bartpol s.c. Z. Kostrzewski 30/10/05<br />

10932 Propolisan Medicated powder 30 mg/g Apipol — Farma Sp. z o.o.<br />

Przedsie˛biorstwo Pszczelarsko<br />

— Farmaceutyczne<br />

10933 Propranitrat Isosorbidi dinitras +<br />

Propranololum<br />

Tablets 10mg + 20mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

10934 Propranolol Propranololum Solution for injection 1 mg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10935 Propranolol Propranololum Tablets 10 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10936 Propranolol Propranololum Tablets 40 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10937 Propranolol prolongatum 80 Propranololum Prolonged release<br />

tablets<br />

10938 Propranolol prolongatum 160 Propranololum Prolonged release<br />

tablets<br />

80 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

160 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/10/05<br />

31/01/06<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/11/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1221<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10939 Propycil Propylthiouracilum Tablets 50 mg Solvay Pharmaceuticals<br />

GmbH<br />

31/07/04<br />

10940 Propylu hydroksybenzoesan Caesar & Loretz GmbH Caelo 31/08/05<br />

10941 Propyphenazonum 100 Propyphenazonum Suppository 0.1 g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

10942 Propyphenazonum 300 Propyphenazonum Suppository 0.3 g GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

10943 Proscar Finasteridum Tablets 5 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

31/01/06<br />

31/01/06<br />

22/06/05<br />

10944 Proscillaridin Proscillaridinum Film-coated tablets 0.25 mg Instytut Farmaceutyczny 31/12/04<br />

10945 Proscillaridin Proscillaridinum Film-coated tablets 250 mcg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

10946 Prosen Zolpidemum Tablets 10 mg Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

10947 ProSobee 1 Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

10948 ProSobee 1 Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

10949 ProSobee 2 Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

10950 ProSobee 2 Dieta eliminacyjna w<br />

nietolerancji pokarmowej<br />

Powder Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Powder for solution 524 kcal/100 g Mead Johnson b.v. a Bristol<br />

Myers Squibb Company<br />

Powder 1981 kJ/100 g Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Powder for solution Mead Johnson b.v.a Bristol —<br />

Myers Company<br />

10951 Prosolvin Luprostiol Solution for veterinary<br />

use<br />

10952 Prospan Hederae helicis folium<br />

extractum siccum<br />

10953 Prospan Hederae helicis folium<br />

extractum siccum<br />

31/01/06<br />

31/12/08<br />

31/12/05<br />

30/06/04<br />

31/12/07<br />

31/12/07<br />

Intervet International 31/12/08<br />

Oral drops 20 mg/ml Engelhard Arzneimittel<br />

GmbH & Co KG<br />

Syrup 35 mg/5ml Engelhard Arzneimittel<br />

GmbH & Co KG<br />

31/07/05<br />

31/07/05<br />

10954 Prostafin (prostan-stara nazwa) Tablets Vitabalans Oy 31/12/08<br />

10955 Prostaflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

30/04/05<br />

10956 Prostaforce Serenoa repens Capsuels, hard 320 mg Bioforce AG 21/06/06<br />

10957 Prostaherb N Urticae radix extractum Coated tablets 230 mg Julius Redel CESRA —<br />

Arzneimittelfabrik GmbH<br />

10958 Prostalizyna Urticae radix extractum<br />

fluidum<br />

Paste for oral<br />

suspension<br />

Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

10959 Prostamed Preparat złoz˙ony Tablets Dr Gustav Klein-<br />

Arzneipflazen-Forchung,<br />

Niemcy<br />

10960 Prostamer Cucrbitae peponis oleum Capsules, soft Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

10961 Prostamol Uno Sabalis serrulatae<br />

extractum<br />

Capsules 320 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

10962 Prostandril Flutamidum Tablets 250 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/04/04<br />

31/12/08<br />

31/12/08<br />

14/03/07<br />

31/03/07<br />

30/09/05


EN<br />

1222 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10963 Prostaplant Serenoa repens extractum Capsules 320 mg Dr Willmar Schwabe GmbH<br />

&Co<br />

10964 Prostapol Preparat ziołowy Oral solution Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

10965 Prostasabal Sabal fructus extractum<br />

spissum<br />

31/12/08<br />

30/10/05<br />

Capsules, soft 320 mg R.P.Scherer GmbH & Co. KG 31/12/08<br />

10966 Prostasan fix Instant herbal tea Herbapol Lublin S.A. 30/10/05<br />

10967 Prostaserene Serenoae repentis fructus<br />

extractum<br />

10968 Prostaserene Serenoae repentis fructus<br />

extractum<br />

Capsules, soft 160 mg Therabel Pharma S.A. 31/12/08<br />

Capsules, soft 320 mg Therabel Pharma S.A. 31/12/08<br />

10969 Prostaten Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

10970 Prostaten — fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp. z<br />

o.o. — Zastawna<br />

30/10/05<br />

10971 Prostatic Doxazosinum Tablets 1 mg Schwarz Pharma Sp. z o.o. 11/10/06<br />

10972 Prostatic Doxazosinum Tablets 2 mg Schwarz Pharma Sp. z o.o. 11/10/06<br />

10973 Prostatic Doxazosinum Tablets 4 mg Schwarz Pharma Sp. z o.o. 11/10/06<br />

10974 Prostatin Finasteridum Tablets 5 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

10975 Prostatobonisan Instant herbal tea Laboratorium Medycyny<br />

Naturalnej BONIMED, Z˙ywiec<br />

10976 Prostatol Drops Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

10977 Prostatonin Pygeum africanum +<br />

Urticae radix extractum<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Capsules Pharmaton S.A. 30/04/04<br />

10978 Prostatoziół Herbal tea Przetwórnia Ziół ‘Ziółmix’,<br />

Łódz´<br />

10979 Prostavasin 20 Alprostadilum Powder for solution<br />

for intravenous or<br />

intraartery infusion<br />

10980 Prostavasin 20 Alprostadilum Powder for solution<br />

for intravenous or<br />

intraartery infusion<br />

10981 Prostavasin 40 Alprostadilum Powder for solution<br />

for intravenous<br />

infusion<br />

10982 Prostavasin 40 Alprostadilum Powder for solution<br />

for intravenous<br />

infusion<br />

10983 Prostavasin 60 Alprostadilum Powder for solution<br />

for intravenous<br />

infusion<br />

10984 Prostavasin 60 Alprostadilum Powder for solution<br />

for intravenous<br />

infusion<br />

31/12/08<br />

20 mcg Schwarz Pharma AG 31/05/04<br />

20 mcg Schwarz Pharma Sp. z o.o. 30/11/05<br />

40 mcg Schwarz Pharma Sp. z o.o. 28/02/06<br />

40 mcg Schwarz Pharma AG 31/08/04<br />

60 mcg Schwarz Pharma AG 31/08/04<br />

60 mcg Schwarz Pharma Sp. z o.o. 28/02/06<br />

10985 Prostavit Bional Pharma BV 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1223<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

10986 Prosterol Sitosterolum Capsules 6 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

30/10/05<br />

10987 Prostin VR Alprostadilum Solution for injection 500 mcg/ml Pharmacia N.V./S.A. 30/06/04<br />

10988 Prostogal Cucrbitae peponis oleum Capsules 7 mg Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

10989 PROSURE O Smaku<br />

Waniliowym<br />

Dieta Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

10990 Proszek do płukanki (Gargarin ) powder for liquid for<br />

mouth wash<br />

Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

10991 Proszek troisty Aflofarm Farmacja Polska,<br />

Pabianice<br />

10992 Proszek troisty Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

30/04/06<br />

31/12/08<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

10993 Proszek troisty Maggie, Warszawa 31/12/05<br />

10994 Protadina Cyproheptadinum Tablets 4 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

10995 Protaminum sulfuricum Protaminum Solution for<br />

intravenous injection<br />

10 mg/ml Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

10996 Protaminum sulfuricum 2 % Protaminum Oromucosal gel 20 mg/g Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

10997 Proten Plus o smaku<br />

czekoladowym<br />

10998 Proten Plus o smaku<br />

truskawkowym<br />

10999 Proten Plus o smaku<br />

waniliowym<br />

11000 Prothromplex Total TIM 4 Koncentrat wszystkich<br />

ludzkich czynników<br />

zespół protombiny<br />

Alimentation liquid 420 kJ/100 ml Fresenius Kabi Deutschland<br />

GmbH<br />

Alimentation liquid 420 kJ/100 ml Fresenius Kabi Deutschland<br />

GmbH<br />

Alimentation liquid 420 kJ/100 ml Fresenius Kabi Deutschland<br />

GmbH<br />

Lyophilisate for<br />

intravenous injection<br />

and intravenous<br />

infusion<br />

30/09/05<br />

31/01/06<br />

31/01/06<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

600 j.m. Baxter AG 31/12/07<br />

11001 Protifar Powder Nutricia Cuijk B.V 30/06/07<br />

11002 Protokur Hydrocortisonum +<br />

Cinchocainum +<br />

Neomycinum +<br />

Aesculinum<br />

11003 Proursan Acidum<br />

ursodeoxycholicum<br />

11004 Provac i-3 Szczepionka la kur<br />

przeciw zakaz´nemu<br />

zapaleniu torby<br />

Fabrycjusza,<br />

rzekomemu pomorowi<br />

drobiu, zakaz´nemu<br />

zapaleniu oskrzeli kur<br />

Rectal ointment ZIAJA Ltd. Zakład<br />

Produkcyjny Gdańsk<br />

31/12/08<br />

Capsules 250 mg PRO. MED. C.S., Praha a.s. 31/12/08<br />

Emulsion for veterinary<br />

use<br />

Fort Dodge 7/07/05


EN<br />

1224 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11005 Provac I-4 Szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu torby<br />

Fabrycjusza,<br />

rzekomemu pomorowi<br />

drobiu, zakaz´nemu<br />

zapaleniu oskrzeli,<br />

zakaz˙eniom<br />

wywołanym przez<br />

reowirusy<br />

Oil emulsion for veterinary<br />

use<br />

Fort Dodge 30/01/05<br />

11006 Provasan Nicametatum Film-coated tablets 50 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

11007 Provera Medroxyprogesteronum Granules for oral<br />

suspension<br />

11008 Provera Medroxyprogesteronum Granules for oral<br />

suspension<br />

1000 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

500 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

11009 Provera Medroxyprogesteronum Tablets 10 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

30/11/05<br />

31/01/05<br />

31/01/05<br />

30/06/04<br />

11010 Provera Medroxyprogesteronum Tablets 100 mg Pharmacia & Upjohn Ltd. 30/06/04<br />

11011 Provera Medroxyprogesteronum Tablets 5 mg Pharmacia N.V./S.A. 30/06/04<br />

11012 Provera Medroxyprogesteronum Tablets 500 mg Pharmacia & Upjohn Ltd. 30/06/04<br />

11013 Proviron-25 Mesterolonum Coated tablets 25 mg Schering AG 31/07/04<br />

11014 Provisc Acidum hyaluronicum Solution for<br />

intraocular use<br />

11015 Provitina C forte Acidum ascorbicum<br />

(vit C)<br />

10 mg/ml Alcon Laboratoires Inc Texas 31/01/05<br />

powder for solution 0.5 g/4 g Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

11016 Provitina Cynk Zinci gluconas Tablets 30 mg Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

11017 Provitina Magnesium Magnesii gluconas Granules 58 mg Mg++/<br />

4g<br />

11018 Provitina Magnesium + B6 Magnesii hydroaspartas<br />

+ Magnesii<br />

lactoglubionas +<br />

Pyridoxinum (vit B6)<br />

Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

Buccal tablet Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

11019 Provitina Mangan Manganesi gluconas Syrup 10 mg Mn2+/<br />

5ml<br />

Łowicke Zakłady<br />

Farmaceutyczne POLFA<br />

Łyszkowice<br />

11020 Proxacin 0,3 % Ciprofloxacinum Eye drops 3 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

11021 Proxacin 1 % Ciprofloxacinum Concantrate for<br />

solution for<br />

intravenous infusion<br />

11022 Proxacin 1 % Ciprofloxacinum Concantrate for<br />

solution for<br />

intravenous infusion<br />

100 mg/10 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

200 mg/20 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

11023 Proxacin 100 Ciprofloxacinum Film-coated tablets 100 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

11024 Proxacin 250 Ciprofloxacinum Film-coated tablets 250 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

11025 Proxacin 500 Ciprofloxacinum Film-coated tablets 500 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/01/06<br />

31/12/08<br />

31/12/05<br />

31/12/08<br />

31/12/08<br />

27/09/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1225<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11026 Proxacin 750 Ciprofloxacinum Film-coated tablets 750 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

11027 Prozac Fluoxetinum Capsules 20 mg Eli Lilly and Company Ltd 31/07/04<br />

11028 PR-Vac Plus Szczepionka przeciw<br />

chorobie Aujeszkyego<br />

Lyophilisate for veterinary<br />

use<br />

Pfizer 31/12/07<br />

11029 Przezie˛bienie Homeoporady Granules Laboratoires BOIRON 19/09/07<br />

11030 Pseudogravin Bromokryptyny<br />

metanosulfonian<br />

11031 Pseudophin Paracetamolum +<br />

Pseudoephedrinum<br />

11032 Pseudovac Szczepionka wiellowazna<br />

przeciw Pseudomonas<br />

aeruginosa<br />

Tablet for veterinary<br />

use<br />

Film-coated tablets 500 mg +<br />

25 mg<br />

Suspension for<br />

intramuscular<br />

injection<br />

Werfft-Chemie 5/07/04<br />

US Pharmacia 31/12/08<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

11033 Psoderm Calcipotriolum Gel 50 mg Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

11034 Psorimed Acidum salicylicum Coutanous liquid Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

11035 Psorinoheel N Amp. Heel GmbH 31/12/08<br />

11036 Psorinoheel N Drops Heel GmbH 31/12/08<br />

11037 Psorisan 5 % Acidum salicylicum +<br />

Pix litanthracis + Zinci<br />

oxydum<br />

11038 Psorisan 10 % Acidum salicylicum +<br />

Pix litanthracis + Zinci<br />

oxydum<br />

11039 Psorisan 20 % Acidum salicylicum +<br />

Pix litanthracis + Zinci<br />

oxydum<br />

11040 Psychotonin Forte Hyperici herbae<br />

extractum siccum<br />

Ointment R & C — Przedsie˛biorstwo<br />

Farmaceutyczne s.c.<br />

Ointment R & C — Przedsie˛biorstwo<br />

Farmaceutyczne s.c.<br />

Ointment R & C — Przedsie˛biorstwo<br />

Farmaceutyczne s.c.<br />

Capsules, soft 0.5 mg<br />

hiperycyny<br />

Steigerwald Arzneimittelwerk<br />

GmbH<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

6/07/05<br />

11041 Psychotonisol Preparat ziołowy Oral solution Phytopharm Kle˛ka S.A. 31/12/07<br />

11042 Puder Płynny Benzocainum +<br />

Mentholum + Zinci<br />

oxydum<br />

11043 Puder płynny Mentholum + Zinci<br />

oxydum<br />

Cutaneous suspension Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

30/10/05<br />

Cutaneous suspension Farmina Sp. z o.o. 30/10/05<br />

11044 Puder Płynny Preparat złoz˙ony Cutaneous suspension Cefarm Lublin S.A.<br />

Przedsie˛biorstwo<br />

Zaopatrzenia<br />

Farmaceutycznego<br />

11045 Puder płynny wysuszaja˛cy Zinci oxydum Cutaneous suspension 250 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

11046 Puder płynny z anestezyna˛ Benzocainum + Zinci<br />

oxydum<br />

11047 Pudroderm Benzocainum +<br />

Mentholum + Zinci<br />

oxydum<br />

11048 Pudrospan — Puder płynny Benzocainum +<br />

Mentholum + Zinci<br />

oxydum<br />

Cutaneous suspension (20mg +<br />

240mg)/g<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Cutaneous suspension Pampa — Laboratorium<br />

Farmaceutyczno-Kosmetyczne<br />

Cutaneous suspension (10mg +<br />

200mg +<br />

20mg)/g<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

30/10/05<br />

11/07/06<br />

31/03/07<br />

31/01/06<br />

15/10/06


EN<br />

1226 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11049 Pularyl płyn Karbaryl Liquid for veterinary<br />

use<br />

11050 Pulcox 12 % sól sodowa<br />

salinomycyny<br />

Premix for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

25/05/04<br />

Biovet Join Company 31/12/08<br />

11051 Pulmex Preparat złoz˙ony Ointment Novartis Consumer Health<br />

S.A.<br />

11052 Pulmex Baby Rosmarini oleum +<br />

Eucalypti oleum +<br />

Balsamum peruvianum<br />

Ointment (50mg + 50mg<br />

+ 60mg)/g<br />

Novartis Consumer Health<br />

S.A.<br />

31/07/04<br />

31/07/04<br />

11053 Pulmicort Budesonidum Nebuliser suspension 0.125 mg/ml AstraZeneca AB 30/11/04<br />

11054 Pulmicort Budesonidum Nebuliser suspension 0.25 mg/ml AstraZeneca AB 30/11/04<br />

11055 Pulmicort Budesonidum Nebuliser suspension 0.5 mg/ml AstraZeneca AB 30/11/04<br />

11056 Pulmicort Turbuhaler Budesonidum Inhalation powder 100 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

11057 Pulmicort Turbuhaler Budesonidum Inhalation powder 200 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

11058 PULMO/VIVIANIT comp.<br />

ampułki<br />

AstraZeneca AB 6/08/06<br />

AstraZeneca AB 6/08/06<br />

WALA-Heilmittel GmbH 19/03/05<br />

11059 Pulmobonisan Herbal tea Bonimed Laboratorium<br />

Medycyny Naturalnej<br />

11060 Pulmobonisan Instant herbal tea Laboratorium Medycyny<br />

Naturalnej ‘BONIMED’,<br />

Z˙ywiec<br />

11061 Pulmocare (o smaku<br />

truskawkowym)<br />

11062 Pulmocare (o smaku<br />

waniliowym)<br />

11063 Pulmocare (o smaku<br />

waniliowym)<br />

Preparat odz˙ywczy Liquid Ross Products Division-<br />

Abbott Laboratories<br />

Preparat odz˙ywczy Liquid Ross Products Division-<br />

Abbott Laboratories<br />

Preparat odz˙ywczy Liquid Abbott Laboratories B.V. Ross<br />

Product Manufacturer<br />

11064 Pulmodexane Dextometorphanum Oral solution 300 mg/<br />

100 ml<br />

11065 Pulmodox Premiks 5 % Doxycyclinum Premix for veterinary<br />

use<br />

Laboratories A. Bailly —<br />

Speeb<br />

5/07/05<br />

5/07/05<br />

30/04/05<br />

30/04/05<br />

30/04/05<br />

31/12/08<br />

Virbac S.A. 22/05/06<br />

11066 Pulmonil Ointment Pampa — Laboratorium<br />

Farmaceutyczno-Kosmetyczne<br />

27/03/06<br />

11067 Pulmosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 31/01/05<br />

11068 Pulmotil 200 Tilmikozyna Premix for veterinary<br />

use<br />

11069 Pulmotil AC Tylmikozyna Solution for veterinary<br />

use<br />

11070 Pulmozen Balsamum peruwianum,<br />

Rosmarini aetheroleum,<br />

Eucalipti aetheroleum<br />

11071 Pulmozen Baby Balsamum peruwianum,<br />

Rosmarini aetheroleum,<br />

Eucalipti aetheroleum<br />

Elanco Animal Health 7/02/04<br />

Eli Lilly Regional Operations<br />

Ges. m.b.H<br />

Ointment ZIAJA Ltd. Zakład<br />

Produkcyjny Gdańsk<br />

Ointment ZIAJA Ltd. Zakład<br />

Produkcyjny Gdańsk<br />

8/05/06<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1<strong>227</strong><br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11072 Pulmozyme Dornasum alfa Nebuliser solution 1 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

11073 Pulpomixine Dexamethasonum +<br />

Framycetinum +<br />

Polymyxinum B<br />

Paste (10mg +<br />

16730 j.m. +<br />

20000 j.m.)/g<br />

11/12/05<br />

Septodont 30/04/04<br />

11074 Pulsaren 10 Quinaprilum Film-coated tablets 10 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

11075 Pulsaren 20 Quinaprilum Film-coated tablets 20 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

11076 Pulsaren 5 Quinaprilum Film-coated tablets 5 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

11077 Pulsatilla compositum Amp. Heel GmbH 31/12/08<br />

11078 Pulvis pro irrigatione Acidum boricum + Zinci<br />

sulfas<br />

Powder Farmina Sp. z o.o. 31/12/04<br />

11079 Pumkin Seed Oil Cucrbitae peponis oleum Capsules 0.3 g Power Health Products Ltd. 30/04/04<br />

11080 Pumpan Drops Richard Bittner 9/09/07<br />

11081 Pumpkin Seed Oil Cucrbitae peponis oleum Capsules 0.275 g Bio Oil International Ltd. 30/04/04<br />

11082 Puregon Follitropinum beta Solution for<br />

intramuscular and<br />

subcutaneous<br />

injection<br />

11083 Puregon Follitropinum beta Solution for<br />

intramuscular and<br />

subcutaneous<br />

injection<br />

11084 Puregon 50 Follitropinum beta Lyophilisate for<br />

solution for<br />

subcutaneous and<br />

intramuscular<br />

injection<br />

11085 Puregon 75 Follitropinum beta Lyophilisate for<br />

solution for<br />

subcutaneous and<br />

intramuscular<br />

injection<br />

11086 Puregon 100 Follitropinum beta Lyophilisate for<br />

solution for<br />

subcutaneous and<br />

intramuscular<br />

injection<br />

11087 Puregon 150 Follitropinum beta Lyophilisate for<br />

solution for<br />

subcutaneous and<br />

intramuscular<br />

injection<br />

11088 Purethal Mieszanki wycia˛gów<br />

alergenowych<br />

pochodzenia ros´linnego<br />

(pyłki ros´lin)<br />

11089 Purethal Wyciagi alergenowe<br />

pochodzenia ros´linnego<br />

(pyłki ros´lin)<br />

11090 Purex Echinaceae extractum<br />

spissum<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

100 j.m./0,5 ml Organon N.V. —<br />

Kloosterstraat<br />

50 j.m./0,5 ml Organon N.V. —<br />

Kloosterstraat<br />

50 j.m. Organon N.V. —<br />

Kloosterstraat<br />

75 j.m. Organon N.V. —<br />

Kloosterstraat<br />

100 j.m. Organon N.V. —<br />

Kloosterstraat<br />

150 j.m. Organon N.V. —<br />

Kloosterstraat<br />

500 µg modyfikowanych<br />

alergenów w<br />

1ml<br />

500 µg modyfikowanych<br />

alergenów w<br />

1ml<br />

Hal Allergen Laboratories<br />

B.V.<br />

Hal Allergen Laboratories<br />

B.V.<br />

Ointment Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

21/06/06<br />

21/06/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

26/09/07<br />

26/09/07<br />

31/12/08


EN<br />

1228 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11091 Purgansen Sennae folium extractum<br />

fluidum<br />

Paste for oral<br />

suspension<br />

10-15mg/3g Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

11092 Purgaten fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp.<br />

z o.o. — Zastawna<br />

11093 Purinethol Mercaptopurinum Tablets 50 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

11094 Purisole SM diluted Mannitolum +<br />

Sorbitolum<br />

Bladder irrigation (5,4mg +<br />

27mg)/ml<br />

Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

11095 PV Jod Povidone-iodine Cream 100 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

11096 PV Jod 10 % Povidone-iodine Solution 100 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

11097 PVP-Iodine Povidone-iodine Cream 100 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

11098 Pycnoven Pinus cortex extractum<br />

siccum<br />

Film-coated tablets 50 mg Zakłady Farmaceutyczno —<br />

Aerozolowe ‘UNIA’<br />

Spółdzielnia Pracy<br />

11099 Pylorid Ranitidinum Film-coated tablets 400 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

11100 Pyoctanini 3 % Pioktanina Liquid for veterinary<br />

use<br />

11101 Pyoctaninum coeruleum 1 % Methylrosanilinii<br />

chloridum<br />

11102 Pyoctaninum coeruleum 1 % Methylrosanilinii<br />

chloridum<br />

11103 Pyoctaninum Coeruleum<br />

Solutum 0,5 %<br />

Methylrosanilinii<br />

chloridum<br />

Ethane solution 10 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

31/05/06<br />

30/10/05<br />

30/06/04<br />

30/04/05<br />

24/08/05<br />

28/02/06<br />

6/06/07<br />

31/12/08<br />

31/07/05<br />

Chema-Elektromet 7/06/04<br />

Water solution 1 % Laboratorium Galenowe<br />

Katowice<br />

Coutanous liquid 5 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

30/06/06<br />

30/06/06<br />

10/05/06<br />

11104 Pyostacine Pristinamycinum Film-coated tablets 250 mg Rhône-Poulenc Rorer Specia 30/09/04<br />

11105 Pyostacine Pristinamycinum Film-coated tablets 500 mg Rhône-Poulenc Rorer Specia 30/09/04<br />

11106 Pyralgin Metamizolum natricum Solution for injection 0.5 g/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

11107 Pyralginum Metamizolum natricum Suppository 750 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

11108 Pyralginum Metamizolum natricum Tablets 500 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

11109 Pyralvex Rhei radix extractu<br />

siccum, Salicylic acid<br />

11110 Pyralvex Rhei radix extractum<br />

siccum, Salicylic acid<br />

31/01/06<br />

30/06/06<br />

31/07/05<br />

Oromucosal solution Norgine Pharma 31/12/08<br />

Oromucosal gel Norgine Pharma 31/12/08<br />

11111 Pyramidonum Aminophenazonum Tablets 100mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

11112 Pyramidonum Aminophenazonum Tablets 200mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

11113 Pyrantel — Pasta dla psów Pyrantelu embonian Paste for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

Vetos-Farma 3/09/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1229<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11114 Pyrantel pasta dla koni Embonian pyrantelu Paste for veterinary<br />

use<br />

11115 Pyrantel pasta dla kotów Embonian pyrantelu Paste for veterinary<br />

use<br />

11116 Pyrantel-Pasta Pyrantelu embonian Paste for veterinary<br />

use<br />

Vetos-Farma 31/12/08<br />

Vetos-Farma 31/12/08<br />

Eurovet Animal Health B.V. 27/02/06<br />

11118 Pyrantelum Pyrantelum Oral suspension 250 mg/5ml Medana Pharma Terpol<br />

Group S.A.<br />

11117 Pyrantelum Pyrantelum Tablets 250 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

11119 Pyrantesan Prantelu winian Powder for veterinary<br />

use<br />

11120 Pyrantverm Pyrantelu winian Powder for veterinary<br />

use<br />

Grodziskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

11121 Pyrazinamid Pyrazinamidum Tablets 500 mg Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

11122 Pyrilax Bisacodylum Film-coated tablets 5 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

11123 Pyrimen Pyrimethaminum Tablets 25 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/01/06<br />

31/01/06<br />

31/12/08<br />

29/04/04<br />

31/01/06<br />

30/06/04<br />

30/01/05<br />

11124 Pyromix Herba Oskar, Wierzbówiec 31/12/08<br />

11125 Pyrosal Syrup Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

11126 Pyrosal® forte Salicis cortex ext.<br />

sicc.,Extr. flu. (1:1,5) ex:<br />

Tiliae infl. 60cz.,<br />

Sambuci fl. 40 cz.<br />

Syrup Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

30/10/05<br />

31/12/08<br />

11127 Pyrosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

11128 Pyrosan fix Mieszanka ziołowa Instant herbal tea Herbapol Łódz´ S.A. 8/02/06<br />

11129 Pyrotex-fix Mieszanka ziołowa Instant herbal tea Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

11130 PYRSVAC-183 Szczepionka przeciw<br />

płucnej postaci<br />

zespołu rozrodczooddechowego<br />

s´wiń<br />

Lyophilisate + solvent for veterinary<br />

use<br />

30/10/05<br />

Laboratorios Syva S.A. 28/07/05<br />

11131 Pz Shampo Pyrithionum zincicum Medicated shampoo Przedsie˛biorstwo Zagraniczne<br />

Farmaceutyczno —<br />

Kosmetyczne OCEANIC<br />

11132 Qetin Quetiapinum Film-coated tablets 25 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

11133 Qetin Quetiapinum Film-coated tablets 100 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

11134 Qetin Quetiapinum Film-coated tablets 200 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

1230 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11135 Quadractin Inaktywowana<br />

szczepionka dla kur<br />

przeciw rzekomemu<br />

pomorowi drobiu,<br />

zakaz´nemu zapaleniu<br />

torby Fabrycjusza,<br />

zakaz´nemu zapaleniu<br />

oskrzeli i<br />

reowirusowemu<br />

zapaleniu stawów<br />

11136 Quadramet Natrii samarii (153 Sm)<br />

lexidronamum<br />

11137 Quadrasa Natrii p —<br />

aminosalicylas<br />

11138 Quadricat Szczepionka dla kotów<br />

przeciw panleukopenii,<br />

zakaz˙eniom układu<br />

oddechowego<br />

powodowanym przez<br />

herpeswirusy i<br />

kaliciwirusy oraz<br />

ws´ciekliz´nie<br />

Water — oil emulsion for veterinary<br />

use<br />

Solution for<br />

intravenous injection<br />

(radioactive)<br />

Powder for rectal<br />

soultion<br />

Lyophilisate + solvent for veterinary<br />

use<br />

11139 Quadrisol 100 Wedaprofen Gel for veterinary<br />

use<br />

11140 Quadrisol 5 Wedaprofen Gel for veterinary<br />

use<br />

ABIC Ltd. 22/11/06<br />

Cis bio international B.P. 25/04/07<br />

2 g Laboratoires Norgine Pharma 31/12/08<br />

Merial 7/05/04<br />

Intervet International B.V. 20/10/05<br />

Intervet 31/12/08<br />

11141 Quadropril Spiraprilum Tablets 6 mg Asta Medica AG 31/12/08<br />

11142 Quamatel Famotidinum powder and solvent<br />

for solution for<br />

intravenous injection<br />

20 mg/5 ml Gedeon Richter Ltd. 30/09/07<br />

11143 Quamatel Famotidinum Tablets 20 mg Gedeon Richter Ltd. 31/03/07<br />

11144 Quamatel Famotidinum Tablets 40 mg Gedeon Richter Ltd. 31/03/07<br />

11145 Quanpar 6 Szczepionka przeciw<br />

nosówce, zakaz´nemu<br />

zapaleniu wa˛troby,<br />

parainfluenzie,<br />

parwowirozie<br />

(liofilizat) i<br />

leptospirozie<br />

(zawiesina)<br />

11146 Quantum Dog DA2PPvL+Cv szczepionka dla psów<br />

przeciw nosówce,<br />

zakaz´nemu zapaleniu<br />

wa˛troby,<br />

parainfluenzie,<br />

chorobie<br />

parwowirusowej,<br />

leptospirozie i<br />

chorobie<br />

koronawirusowej<br />

Lyophilisate +<br />

suspension<br />

Lyophilisate + liquid<br />

component<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

Diamond Animal Health Inc. 31/12/08<br />

Schering Plough 31/12/08<br />

11147 Quassia similiaplex krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

11148 Quecor Quercus cortex pulv. Tablets 370 mg Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

30/11/05<br />

31/12/08<br />

11149 Quentakehl D5 krople Sanum-Kehlbeck 31/12/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1231<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11150 QUERCUS Ointment WALA-Heilmittel GmbH 24/05/07<br />

11151 Questran Colestyraminum Powder for oral<br />

suspension<br />

4 g Bristol-Myers Squibb 21/05/06<br />

11152 Quinax Eye drops 0.15 mg/ml Alcon Couvreur N.V. 22/03/05<br />

11153 Quintor 250 Ciprofloxacinum Film-coated tablets 250 mg Torrent Pharmaceuticals Ltd. 31/12/08<br />

11154 Quintor 500 Ciprofloxacinum Film-coated tablets 500 mg Torrent Pharmaceuticals Ltd. 31/12/08<br />

11155 Quolifex Nabumetonum Film-coated tablets 500 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

11156 Rabdomun Szczepionka przeciw<br />

ws´ciekliz´nie dla psów,<br />

kotów i bydła<br />

11157 Rabigen mono Szczepionka przeciw<br />

ws´ciekliz´nie psów,<br />

kotów, bydła i koni<br />

11158 Rabigen oral Szczepionka przeciw<br />

ws´ciekliz´nie lisów<br />

11159 Rabipur Rabies, inactivated,<br />

whole virus<br />

11160 Rabisin Szczepionka przeciw<br />

ws´ciekliz´nie dla psów,<br />

kotów, koni owiec,<br />

bydła, zwierza˛t<br />

futerkowych<br />

Liquid for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Oral vaccine for veterinary<br />

use<br />

Lyophilisate for<br />

solution for<br />

intramuscular<br />

injection<br />

Liquid for veterinary<br />

use<br />

31/12/08<br />

Schering Plough 30/06/04<br />

Virbac 25/04/04<br />

Virbac 31/12/04<br />

2.5 j.m./1 ml Chiron Behring GmbH & Co. 29/02/04<br />

Merial SAS 31/12/08<br />

11161 Radirex Tablets 513.5 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

11162 Ragastin Ranitidinum Film-coated tablets 150 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11163 Ragastin 0,05 % Ranitidinum Solution for<br />

intravenous infusion<br />

11164 Ramigen Ramiprilum Tablets 1,25 mg ,<br />

2,5 mg , 5 mg<br />

0.5 mg/ml Fresenius Kabi Polska Sp.<br />

z o.o.<br />

30/10/05<br />

30/10/05<br />

27/04/05<br />

GENEXO Sp.z.o.o Warszawa 31/12/08<br />

11165 Ramipril Ramiprilum Tablets 1,25 mg POL-NIL Sp. z.o.o. 31/12/08<br />

11166 Ramipril Ramiprilum Tablets 2,5 mg POL-NIL Sp. z.o.o. 31/12/08<br />

11167 Ramipril Ramiprilum Tablets 5 mg POL-NIL Sp. z.o.o. 31/12/08<br />

11168 Ramipril Ramiprilum Tablets 1,25 mg POLFA KUTNO S.A. 31/12/08<br />

11169 Ramipril Ramiprilum Tablets 2,5 mg POLFA KUTNO S.A. 31/12/08<br />

11170 Ramipril Ramiprilum Tablets 5 mg POLFA KUTNO S.A. 31/12/08<br />

11171 Ramoclav Acidum clavulanicum +<br />

Amoxicillinum<br />

11172 Ramoclav Acidum clavulanicum +<br />

Amoxicillinum<br />

Film-coated tablets 375 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

Film-coated tablets 625 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

30/09/05<br />

30/09/05<br />

11173 Ramphamax Compositum Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

11174 Raniberl Ranitidinum Film-coated tablets 150 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

26/10/05


EN<br />

1232 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11175 Raniberl 300 Ranitidinum Film-coated tablets 300 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

11176 Ranic Ranitidinum Solution for injection<br />

and intravenous<br />

infusion<br />

29/06/05<br />

10 mg/ml Hexal AG 23/11/05<br />

11177 Ranic 150 Ranitidinum Film-coated tablets 150 mg Hexal AG 23/11/05<br />

11178 Ranic 300 Ranitidinum Film-coated tablets 300 mg Hexal AG 23/11/05<br />

11179 Ranigasan 300 Ranitidinum Film-coated tablets Polfarmex Sp. z o.o. 31/12/08<br />

11182 Ranigast Ranitidinum Film-coated tablets 150 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

11183 Ranigast Ranitidinum Film-coated tablets 75 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

11180 Ranigast Ranitidinum Solution for<br />

intravenous infusion<br />

0.5 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

11181 Ranigast Ranitidinum Syrup 150 mg/10 ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

11184 Ranigast Forte Ranitidinum Film-coated tablets 300 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/01/06<br />

31/01/06<br />

31/07/05<br />

31/12/08<br />

31/12/08<br />

11185 Raniratio 150 Ranitidinum Film-coated tablets 150 mg ratiopharm GmbH 23/11/05<br />

11186 Raniratio 300 Ranitidinum Film-coated tablets 300 mg ratiopharm GmbH 23/11/05<br />

11187 Ranisan 150 mg Ranitidinum Film-coated tablets 150 mg PRO. MED. CS. Praha a.s. 31/05/04<br />

11188 RANISAN 75 mg Ranitidinum Film-coated tablets 75 mg PRO. MED. C.S., Praha a.s. 31/12/08<br />

11189 Ranital Ranitidinum Film-coated tablets 150 mg Lek Pharmaceuticals d.d. 31/07/04<br />

11190 Ranitidin Ranitidinum Film-coated tablets 150 mg HEMOFARM D.D. 31/12/08<br />

11191 Ranitidin Ranitidinum Film-coated tablets 300 mg HEMOFARM D.D. 31/12/08<br />

11192 Ranitidine, Gastoren Ranitidinum Syrup 150 mg/10 ml Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

31/12/08<br />

11193 Ranitin — 150 Ranitidinum Film-coated tablets 150 mg Torrent Pharmaceuticals Ltd. 9/09/06<br />

11194 Ranitin — 300 Ranitidinum Film-coated tablets 300 mg Torrent Pharmaceuticals Ltd. 9/09/06<br />

11196 Ranitydyna Ranitidinum Film-coated tablets 150 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11197 Ranitydyna Ranitidinum Film-coated tablets 300 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11200 Ranitydyna Ranitidinum Film-coated tablets 75 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

11195 Ranitydyna Ranitidinum Syrup 75 mg/5 ml Sanofi-Synthelabo Sp. z o.o. 31/12/08<br />

11198 Ranitydyna Ranitidinum Tablets 150 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

11199 Ranitydyna Ranitidinum Tablets 300 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

31/12/08<br />

31/12/08<br />

11201 Ranitydyna 150 Ranitidinum Film-coated tablets 150 mg Sanofi-Synthelabo Sp. z o.o. 31/12/08<br />

11202 Ranitydyna 300 Ranitidinum Film-coated tablets 300 mg Sanofi-Synthelabo Sp. z o.o. 31/12/08<br />

11203 Ranopril 10 Lisinoprilum Tablets 10 mg Ranbaxy Laboratoires Ltd. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1233<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11204 Ranopril 2,5 Lisinoprilum Tablets 2,5 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

11205 Ranopril 20 Lisinoprilum Tablets 20 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

11206 Ranopril 5 Lisinoprilum Tablets 5 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

11207 Rantagon Ranitidinum Drops for children 25 mg/ml Medana Pharma Terpol<br />

Group S.A.<br />

11208 Rantaksym Cefotaximum Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

11209 Rantaksym Cefotaximum Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

11210 Rantaksym Cefotaximum Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

1 g Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

2 g Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

500 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

31/12/08<br />

31/08/05<br />

31/08/05<br />

31/08/05<br />

11211 Rantudil Forte Acemetacinum Capsules 60 mg Bayer AG 31/05/04<br />

11212 Rantudil Retard Acemetacinum Prolonged release<br />

capsules<br />

90 mg Bayer AG 31/05/04<br />

11213 Ranunculus-Homaccord Amp. Heel GmbH 31/12/08<br />

11214 Ranunculus-Homaccord Drops Heel GmbH 31/12/08<br />

11215 Ranviran Aciclovirum Cream 50 mg/g Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

11216 Ranviran Aciclovirum Tablets 200 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

11217 Ranviran Aciclovirum Tablets 400 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

11218 Ranviran Aciclovirum Tablets 800 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

11219 Ranvit-C Acidum ascorbicum<br />

(vit C)<br />

11220 Ranvit-C Acidum ascorbicum<br />

(vit C)<br />

11221 Rapacholin forte Kwas dehydrocholowy,<br />

Wycia˛g suchy z czarnej<br />

rzodkwi z<br />

maltodekstryna˛, Olejek<br />

mie˛towy<br />

14/12/05<br />

16/05/07<br />

16/05/07<br />

16/05/07<br />

Tablets 100 mg Ranbaxy Ireland Ltd 26/04/06<br />

Tablets 50 mg Ranbaxy Ireland Ltd 26/04/06<br />

Film-coated tablet 250 mg +<br />

75 mg +<br />

10 mg<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

11223 Rapamune Sirolimusum Film-coated tablets 1 mg Wyeth — Lederle Pharma<br />

GmbH<br />

31/12/08<br />

31/12/08<br />

11222 Rapamune Sirolimusum Oral solution 1 mg/ml Wyeth-Lederle GmbH 21/06/06<br />

11224 Raphacholin AC Coated tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

11225 Raphacholin C Coated tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

11226 Raphaherb Boldinum + Extractum<br />

Raphani siccum +<br />

Extractum Cynarae<br />

siccum<br />

Capsules, soft Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

12/01/06<br />

30/10/05<br />

31/12/08


EN<br />

1234 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11<strong>227</strong> Raphamax Raphani sativi extr. sicc.,<br />

Curcumae rhiz. extr.<br />

sicc., Fumaraiae herb.<br />

extr. sicc.<br />

Capsules, hard 75 mg +<br />

10 mg +<br />

10 mg<br />

Herbapol — Lublin S.A. 31/12/08<br />

11228 Raphamax Forte Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

11229 Rapicid Jod aktywny, Kwas<br />

fosforowy , Kwas<br />

siarkowy, S´ rodki<br />

powierzchniowo<br />

czynne<br />

Concentrate for<br />

desinfection<br />

for veterinary<br />

use<br />

Evans Vandoline Inter. 31/12/08<br />

11230 Rapifen Alfentanilum Solution for injection 0.5 mg/ml Janssen Pharmaceutica N.V. 30/06/04<br />

11231 Rastocin Doxorubicinum Lyophilisate for<br />

solution for injection<br />

11232 Rastocin Doxorubicinum Powder for solution<br />

for injection<br />

11233 Ratiocord Crataegi inflorescentia<br />

extractum<br />

11234 Raudiazin Dihydralazinum +<br />

Reserpinum<br />

10 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

50 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/04/05<br />

23/11/05<br />

Capsules 50 mg ratiopharm GmbH 30/04/04<br />

Tablets 10mg + 0,1mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

11235 Raupasil Reserpinum Tablets 1 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

11236 Raupasil Reserpinum Tablets 100 mcg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

11237 Raupasil Reserpinum Tablets 250 mcg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

11238 Rauwolfia compositum Amp. Heel GmbH 31/12/08<br />

11239 Re — Bone (Re — 186)<br />

Injection<br />

Preparat<br />

radiofarmaceutyczny<br />

11240 Reasec Atropinum +<br />

Diphenoxylatum<br />

11241 Rebetron Interferonum alfa-2b +<br />

Ribavirinum<br />

11242 Rebetron Interferonum alfa-2b +<br />

Ribavirinum<br />

Tablets 25mcg +<br />

2,5mg<br />

Set for association terapy: capsules,<br />

hard + solution for injection<br />

Set for association terapy: capsules,<br />

hard + solution for injection<br />

11243 Rebif 22 Interferonum beta-1a Solution for<br />

subcutanous injection<br />

22 mcg/0,5 ml<br />

(6 mIU)<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Gedeon Richter Ltd. 31/07/04<br />

Schering-Plough Corporation 6/07/05<br />

Schering-Plough Corporation 6/07/05<br />

Serono-Ares (Europe) Ltd. 30/04/04<br />

11244 Rebif 44 Interferonum beta-1a Solution for injection 44 mcg Ares- Serono (Europe) Ltd 26/04/06<br />

11245 Recalcin Chondroitinum Capsules, soft 400 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/05<br />

11246 Recarcin D4 iniekcje Sanum-Kehlbeck 31/12/05<br />

11247 Recarcin D4 kaps. Sanum-Kehlbeck 31/12/05<br />

11248 Recarcin D6 iniekcje Sanum-Kehlbeck 31/12/05<br />

11249 Recarcin D6 kaps. Sanum-Kehlbeck 31/12/05<br />

11250 Receptal Busereliny octan Solution for veterinary<br />

use<br />

Intervet International B.V. 27/01/04<br />

11251 Recervin Vinpocetinum Tablets 5 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1/08/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1235<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11252 Recombinate Rekombinowany czynnik<br />

krzepnie˛cia VIIII<br />

11253 Recombinate Rekombinowany czynnik<br />

krzepnie˛cia VIIII<br />

11254 Recombinate Rekombinowany czynnik<br />

krzepnie˛cia VIIII<br />

powder and solvent<br />

for solution for<br />

injection<br />

powder and solvent<br />

for solution for<br />

injection<br />

powder and solvent<br />

for solution for<br />

injection<br />

250 j.m. Baxter S.A. 31/12/08<br />

500 j.m. Baxter S.A. 31/12/08<br />

1000 j.m. Baxter S.A. 31/12/08<br />

11255 Reconvan Dieta Liquid Fresenius Kabi Deutschland<br />

GmbH<br />

31/12/08<br />

11256 Recox Nabumetonum Film-coated tablets 500 mg Norton Healthcare Ltd. 15/11/06<br />

11257 Rectanal Natrii phosphas + Natrii<br />

phosphas<br />

11258 Rectobol fix. Species<br />

antihaemorrhoidales<br />

11259 Rectobol. Species<br />

antihaemorrhoidales<br />

Enema Farmaceutyczno —<br />

Chemiczna Spółdzielnia Pracy<br />

Galenus<br />

20/06/07<br />

Herbal tea Eldex-Medical 31/12/06<br />

Herbal tea Eldex-Medical 31/12/06<br />

11260 Rectosec Preparat złoz˙ony Rectal ointment SecFarm — Towarzystwo<br />

Przemysłowo-Handlowe Sp.<br />

z o.o.<br />

11261 Rectosol-Cream Cream R & C — Przedsie˛biorstwo<br />

Farmaceutyczne s.c.<br />

11262 Redinac Calcii carbonas +<br />

Magnesii carbonas<br />

11263 Redormin® Valerianae radix<br />

extractum siccum +<br />

Lupuli strobili extractum<br />

siccum<br />

11264 Red-Slim Tea Hibisci flos + Sennae<br />

folium<br />

31/01/06<br />

30/10/05<br />

Buccal tablet Polfarmex S.A. 14/02/07<br />

Film-coated tablets (250 mg +<br />

60 mg)<br />

EWOPHARMA AG 31/12/08<br />

Instant herbal tea 800 mg/2 g Elanda s.c. — Zakład<br />

Produkcji S´ rodków<br />

Farmaceutycznych<br />

17/01/07<br />

11265 Reducenol Herbal tea Eldex-Medical 2/10/06<br />

11266 Reducenol Instant herbal tea Eldex-Medical 2/10/06<br />

11267 Reducenol-fix Instant herbal tea P.P.H. ‘Eldex-Medical’, Wiry 31/12/08<br />

11268 Reducten fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp.<br />

z o.o. — Zastawna<br />

30/10/05<br />

11269 Reduktin fix Herbapol — Lublin S.A. 31/12/08<br />

11270 Redusan Capsules + Tablets Biokraft Pharma 31/07/04<br />

11271 ReFacto Moroctocogum —<br />

cz.VIII rekombinowany<br />

11272 ReFacto Moroctocogum —<br />

cz.VIII rekombinowany<br />

11273 ReFacto Moroctocogum —<br />

cz.VIII rekombinowany<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

Lyophilisate and<br />

solvent for solution<br />

for injection<br />

1000 j.m.<br />

(250 j.m./ml)<br />

250 j.m.<br />

(62,5 j.m./ml)<br />

500 j.m.<br />

(125 j.m./ml)<br />

Wyeth-Lederle GmbH 31/08/05<br />

Wyeth-Lederle GmbH 31/08/05<br />

Wyeth-Lederle GmbH 31/08/05<br />

11274 Refen Diclofenacum Film-coated tablets 50 mg HEMOFARM D.D. 31/12/08


EN<br />

1236 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11275 Refen 1 % Diclofenacum Gel 1 % HEMOFARM D.D. 31/12/08<br />

11276 Refen Retard Diclofenacum Prolonged release<br />

tablets<br />

11277 Refludan Lepirudinum Powder for solution<br />

for injection or<br />

intravenous infusion<br />

100 mg HEMOFARM D.D. 31/12/08<br />

50 mg Aventis Pharma Deutschland<br />

GmbH<br />

29/08/07<br />

11278 Regaine Minoxidilum Coutanous liquid 20 mg/ml Pharmacia N.V./S.A. 30/06/04<br />

11280 Regaine Minoxidilum Gel 20 mg/g Pharmacia N.V./S.A. 14/05/06<br />

11279 Regaine Minoxidilum Szolution for local use 5 % Pharmacia N.V./S.A. 31/12/08<br />

11281 Regalok Minoxidilum Coutanous liquid 20 mg/g Elanda s.c. — Zakład<br />

Produkcji S´ rodków<br />

Farmaceutycznych<br />

11282 Regla pH Aluminii hydroxidum +<br />

Magnesii carbonas<br />

11283 Regla pH Aluminii hydroxidum +<br />

Magnesii hydroxidum<br />

11284 Regla pH forte Suspension Aluminii hydroxidum +<br />

Magnesii carbonas +<br />

Magnesii hydroxidum<br />

11285 Regranex Becaplerminum Gel 100 mcg/g<br />

(0,1 %)<br />

24/05/06<br />

Tablets UCB S.A. Pharma Sector 31/07/04<br />

Oral suspension UCB S.A. Pharma Sector 31/07/04<br />

Oral suspension UCB S.A. Pharma Sector 31/07/04<br />

Cilag AG 26/08/04<br />

11286 Regulatex-fix Mieszanka ziołowa Instant herbal tea Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

11287 Regulavit Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

11288 Regulavit Instant herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

11289 Regulax Sennae folium pulver +<br />

Sennae fructus pulver<br />

11290 Regulon Desogestrelum +<br />

Ethinylestradiolum<br />

Buccal lozenge 710mg +<br />

300mg<br />

Film-coated tablets 0,15mg +<br />

0,03mg<br />

11291 Regumate Porcine Altrenogestum Solution for veterinary<br />

use<br />

11292 Rehydrat Chlorek sodu, chlorek<br />

potasu, wodorotlenek<br />

sodu, siarczan<br />

cynkowy, glukoza<br />

Powder for veterinary<br />

use<br />

Krewel Meuselbach GmbH<br />

Eitorf<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

31/10/04<br />

Gedeon Richter Ltd. 31/07/04<br />

Intervet International 16/06/05<br />

Biowet Puławy 31/12/08<br />

11293 Rekostin Acidum alendronicum Tablets 10 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

14/02/07<br />

11294 Rektin fix Herbal tea Herbapol Lublin S.A. 31/12/07<br />

11295 Rektiolax Laurilsulfate, incl.<br />

combinations + Natrii<br />

citras + Sorbitolum<br />

Enema Marmir S.C. Zakład Produkcji<br />

Leków<br />

31/01/06<br />

11296 Rektosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

11297 Rektovit Preparat ziołowy Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

31/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1237<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11298 Rektovit Preparat ziołowy Instant herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

11299 Relaksan Hypeici herba cum<br />

extractum siccum.<br />

31/01/05<br />

Film-coated tablets 200 mg Börner GmbH 31/12/08<br />

11300 Relana Tablets Pharbio Medical International<br />

AB<br />

11301 Relana forte Tablets 200 mg Pharbio Medical International<br />

AB<br />

11302 Relanimal Diazepamum Suspension for veterinary<br />

use<br />

Medana Pharma Terpol<br />

Group S.A.<br />

11307 Relanium Diazepamum Film-coated tablets 10 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11308 Relanium Diazepamum Film-coated tablets 5 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11309 Relanium Diazepamum Oral suspension 2 mg/5 ml Medana Pharma Terpol<br />

Group S.A.<br />

11303 Relanium Diazepamum Solution for injection 5 mg/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11304 Relanium Diazepamum Solution for injection 5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

11305 Relanium Diazepamum Tablets 2 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

11306 Relanium Diazepamum Tablets 5 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

11310 Relax Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

11311 Relax Instant herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

11312 Relaxen n Valerianae radix<br />

extractum siccum<br />

11313 Relenza Zanamivirum Inhalation powder 5 mg/dawke˛<br />

inhalacyjna˛<br />

31/08/04<br />

31/08/04<br />

17/04/05<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

31/12/05<br />

31/12/05<br />

31/01/05<br />

31/01/05<br />

Film-coated tablets 441,35 mg Whitehall — Much GmbH 31/12/08<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

11314 Relifex Nabumetonum Film-coated tablets 500 mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

11315 Relisorm L-100 Gonadorelinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

25/01/06<br />

30/04/04<br />

100 mcg Laboratories Serono S.A. 31/07/04<br />

11316 Relpax Eletriptanum Film-coated tablets 20 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

11317 Relpax Eletriptanum Film-coated tablets 40 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

11318 Relsed Diazepamum Rectal microclysmas 10 mg/2,5 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

11319 Relsed Diazepamum Rectal microclysmas 5 mg/2,5 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

27/06/07<br />

27/06/07<br />

31/12/08<br />

31/12/08<br />

11320 Remegel Calcii carbonas Chewable tablets 800 mg SSL International 31/12/08<br />

11321 Remens krople Richard Bittner 31/01/06


EN<br />

1238 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11322 Remeron Mirtazapinum Film-coated tablets 15 mg Organon N.V. 31/03/04<br />

11323 Remeron Mirtazapinum Film-coated tablets 30 mg Organon N.V. 31/03/04<br />

11324 Remeron Mirtazapinum Film-coated tablets 45 mg Organon N.V. 31/03/04<br />

11325 REMERON Soltab Mirtazapinum Oromucosal soluble<br />

tablets<br />

11326 REMERON Soltab Mirtazapinum Oromucosal soluble<br />

tablets<br />

11327 REMERON Soltab Mirtazapinum Oromucosal soluble<br />

tablets<br />

15 mg N.V. Organon 31/12/08<br />

30 mg N.V. Organon 31/12/08<br />

45 mg N.V. Organon 31/12/08<br />

11328 Remestyp Terlipressinum Solution for injection 100 mcg/ml Ferring-Leciva a.s. 31/05/04<br />

11329 Remicade Infliximabum Powder for<br />

concentrate for<br />

solution for infusion<br />

100 mg Schering-Plough Central East<br />

AG<br />

11330 Remifemin Cimicifugae racemosae Tablets Schaper & Brümmer GmbH<br />

& Co. KG<br />

27/06/06<br />

10/05/06<br />

11332 Reminyl Galantaminum Film-coated tablets 12 mg Janssen Pharmaceutica N.V. 12/10/05<br />

11333 Reminyl Galantaminum Film-coated tablets 4 mg Janssen Pharmaceutica N.V. 12/10/05<br />

11334 Reminyl Galantaminum Film-coated tablets 8 mg Janssen Pharmaceutica N.V. 12/10/05<br />

11331 Reminyl Galantaminum Oral solution 4 mg/ml Janssen Pharmaceutica N.V. 12/10/05<br />

11335 Remotiv® Hyperici herbae<br />

extractum siccum<br />

Film-coated tablets 250 mg EWOPHARMA AG 31/12/08<br />

11336 Renagel Sevelamerum Capsuels, hard 403 mg Genzyme B.V 10/05/06<br />

11337 Renagel Sevelamerum Film-coated tablets 400 mg Genzyme Europe B.V. 30/09/07<br />

11338 Renagel Sevelamerum Film-coated tablets 800 mg Genzyme Europe B.V. 30/09/07<br />

11339 Reneel Tablets Heel GmbH 31/12/08<br />

11340 Renicin Roxithromycinum Film-coated tablets 150 mg Lek Polska Sp. z o.o. 31/01/05<br />

11341 Renicin Roxithromycinum Film-coated tablets 150 mg Lek Pharmaceuticals d.d. 31/01/05<br />

11342 Rennie Aniseed Calcii carbonas,<br />

Magnesii carbonas<br />

11343 Rennie Antacidum Calcii carbonas +<br />

Magnesii carbonas<br />

11344 Rennie Deflatine Calcii carbonas,<br />

Magnesii carbonas,<br />

Simeticonum<br />

11345 Rennie Duo Acidum alginicum +<br />

Calcii carbonas +<br />

Magnesii carbonas<br />

11346 Rennie Spearmint Calcii carbonas,<br />

Magnesii carbonas<br />

11347 ReoPro Abciximabum Intravenous injection<br />

(solution)<br />

11348 ReoPro Abciximabum Intravenous injection<br />

(solution)<br />

Buccal tablets F. Hoffmann — La Roche<br />

Ltd.<br />

31/12/08<br />

Buccal tablet Roche Consumer Health Ltd 5/03/06<br />

Buccal tablets F. Hoffmann — La Roche<br />

Ltd.<br />

30/09/07<br />

Oral suspension Roche Consumer Health Ltd 15/03/06<br />

Buccal tablets F. Hoffmann — La Roche<br />

Ltd.<br />

31/12/08<br />

10 mg/5 ml Centecor B.V. 31/12/08<br />

40 mg/20 ml Centecor B.V. 31/12/08<br />

11349 Reparil Coated tablets 20 mg Madaus AG 31/05/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1239<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11350 Reparil Gel N Gel for external use Madaus AG 31/05/04<br />

11351 Repisan Drops Richard Bittner 9/09/07<br />

11352 REPLAGAL 1 mg/Ml Agalzydazum alfa Concentrate for<br />

solution for infusion<br />

1 mg/ml TKT Europe — 5S 31/12/08<br />

11353 Requip Ropinirolum Film-coated tablets 0.25 mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

11354 Requip Ropinirolum Film-coated tablets 0.5 mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

11355 Requip Ropinirolum Film-coated tablets 1 mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

11356 Requip Ropinirolum Film-coated tablets 2 mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

11357 Requip Ropinirolum Film-coated tablets 5 mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

11358 Rescula Isopropyli unoprostonum Eye drops 1.2 mg/ml Novartis Ophthalmics AG<br />

Hettlingen<br />

11359 Resoferon Ferrosi sulfas + Acidum<br />

succinatum<br />

11360 Resonium A Natrii polistyreni<br />

sulfonas<br />

Film-coated tablets 37mg Fe++,<br />

185mg<br />

oral powder or for<br />

rectal suspension<br />

11361 Resovist Ferucarbatron Solution for<br />

intravenous injection<br />

11362 Resoxym Oxymetazolini<br />

hydrochloridum<br />

11363 Resoxym Oxymetazolini<br />

hydrochloridum<br />

11364 Resoxym Oxymetazolini<br />

hydrochloridum<br />

1.42 g Na+/<br />

15g<br />

0,5 mmol Fe/<br />

ml<br />

Novartis Consumer Health<br />

S.A.<br />

Sanofi Winthrop Ltd. —<br />

Guildford<br />

30/09/04<br />

30/09/04<br />

30/09/04<br />

30/09/04<br />

30/09/04<br />

31/12/08<br />

30/01/05<br />

17/11/05<br />

Schering AG 31/12/08<br />

Nasal drops 0.01 % ICN Polfa Rzeszów S.A. 31/12/08<br />

Nasal drops 0.025 % ICN Polfa Rzeszów S.A. 31/12/08<br />

Nasal drops 0.05 % ICN Polfa Rzeszów S.A. 31/12/08<br />

11365 Resoxym Oxymetazolum Nasal spray, solution 0,05 % ICN Polfa Rzeszów S.A. 31/12/08<br />

11366 Respiporc szczepionka przeciwko<br />

zakaz˙eniom<br />

wywołanym przez<br />

bardetella<br />

bronchiseptica i<br />

pasteurella multocida<br />

typu a i d<br />

Suspension for veterinary<br />

use<br />

IDT 31/12/08<br />

11367 Respirovac bakterie Capsules Wytwórnia Surowic i<br />

Szczepionek BIOMED<br />

11368 Respisure Inaktywowana<br />

szczepionka dla s´wiń,<br />

przeciwko<br />

mykoplazmowemu<br />

zapaleniu płuc<br />

11369 Respisure One Inaktywowana<br />

szczepionki dla s´wiń<br />

przeciw<br />

mykoplazmowemu<br />

zapalenia płuc<br />

11370 Restovar Ethinylestradiolum +<br />

Lynestrenolum<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Tablets 0,0375mg +<br />

0,75mg<br />

31/12/08<br />

Pfizer 18/11/07<br />

Pfizer Inc. 17/05/07<br />

Organon N.V. —<br />

Kloosterstraat<br />

30/06/04


EN<br />

1240 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11371 Retardpen Benzylpenicillinum<br />

procainicum +<br />

Benzathini<br />

benzatylpenicillinum<br />

11372 Retarpen 1,2 Benzathini<br />

benzylpenicillinum<br />

11373 Retarpen 2,4 Benzathini<br />

benzylpenicillinum<br />

11374 Retiazid Hydrochlorothiazidum +<br />

Reserpinum<br />

11375 Retiazid Forte Hydrochlorothiazidum +<br />

Reserpinum<br />

Suspension for veterinary<br />

use<br />

Powder for<br />

suspension for<br />

intramuscular<br />

injection<br />

Powder for<br />

suspension for<br />

intramuscular<br />

injection<br />

V.M.D. 31/12/08<br />

1200000 j.m. Biochemie GmbH — Kundl 31/12/08<br />

2400000 j.m. Biochemie GmbH — Kundl 31/12/08<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/01/06<br />

31/01/06<br />

11376 Retin A Tretinoinum Cream 0.5 mg/g Cilag AG 31/07/04<br />

11377 Retiven e Torf Corporation Fabryka<br />

Leków, Wrocław<br />

11378 Retrovir Zidovudinum Capsules 0.1 g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

11379 Retrovir Zidovudinum Capsules 0.25 g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

11382 Retrovir Zidovudinum Film-coated tablets 300 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

11380 Retrovir Zidovudinum Solution for<br />

intravenous infusion<br />

200 mg/20 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

11381 Retrovir Zidovudinum Syrup 50 mg/5 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

11383 Reumacor Camphorum + Methylis<br />

salicylas<br />

11385 Reumacor Extractum siccum<br />

compositum ex: Salicis<br />

cortex + Solidaginis<br />

herbae<br />

11384 Reumacor Extractum siccum<br />

compositum ex: Salicis<br />

cortex + Solidaginis<br />

herbae<br />

Ointment preparat<br />

złoz˙ony<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Film-coated tablets 181,8 mg Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Oral drops 95 mg/1 ml Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

31/07/04<br />

31/07/04<br />

20/06/07<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

11386 Reumador Piroxicamum Gel 5 mg/g Slovakofarma a.s. 30/06/05<br />

11387 Reumaflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

11388 Reumaherb Preparat ziołowy Film-coated tablets 100 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

11389 Reumaphyt Harpagophyti radix<br />

extractum aq. siccum<br />

30/04/05<br />

25/01/06<br />

Capsuels, hard 250 mg Phytopharm Kle˛ka S.A. 23/11/05<br />

11390 Reumatik Preparat złoz˙ony Ointment Dr. Theiss Naturwaren GmbH 31/12/08<br />

11391 Reumobonisan Instant herbal tea Laboratorium Medycyny<br />

Naturalnej BONIMED, Z˙ywiec<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1241<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11392 Reumobonisol Coutanous liquid Laboratorium Medycyny<br />

Naturalnej ‘BONIMED’,<br />

Z˙ywiec<br />

11393 Reumogran Herbal granules Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

11394 Reumokaps Melaleucae alternifoliae<br />

oleum<br />

11395 Reumoplast forte(poprzednia<br />

nazwa: plastry borowinowe)<br />

Masa borowinowa,<br />

Wodny zage˛szcz. wycia˛g<br />

borowinowy<br />

Capsule, soft 50 mg Specjalistyczne<br />

Przedsie˛biorstwo Rolno-<br />

Przetwórcze ‘GAL’ s.c.<br />

Poultice Przedsie˛biorstwo<br />

Farmaceutyczne ‘SULPHUR<br />

— ZDRÓJ’ EXIM Busko-Zdrój<br />

31/12/08<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

11396 Reumosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

11397 Reumosol Preparat ziołowy Solution for<br />

medicated bath<br />

Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

11398 Reumovit Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

30/10/05<br />

30/10/05<br />

11399 Reumovit Instant herbal tea Phytopharm Dobrzyca 31/12/08<br />

11400 Reumpao Preparat złoz˙ony Capsules, hard PT. IKONG Pharmaceutical<br />

Industry CO<br />

11401 Reumpapai Capsuels, hard Ikong Pharmaceutical<br />

Industry Co.<br />

31/12/08<br />

30/11/04<br />

11402 Revalid Capsules Ewopharma AG 31/12/08<br />

11403 Revasc Desirudinum Powder and solvent<br />

for solution for<br />

subcutaneous<br />

injection<br />

15 mg Rhone-Poulenc Rorer S.A. 12/10/05<br />

11404 REVIT — Multivitamin Preparat witaminowy KYIV VITAMIN FACTORY Co 31/12/08<br />

11405 Revitan Mieszanka ziołowa Herbal tea Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

11406 Revitonil Tablets Pharbio Medical Sverige AB,<br />

Sweden<br />

11407 Rewodina 25 Diclofenacum Film-coated tablets 25 mg AWD.pharma GmbH & Co.<br />

KG<br />

11408 Rewodina 50 Diclofenacum Film-coated,<br />

gastro-resistant tablets<br />

11409 Rewodina Retard Diclofenacum Film-coated, prologed<br />

release tablets<br />

50 mg AWD.pharma GmbH & Co.<br />

KG<br />

100 mg AWD.pharma GmbH & Co.<br />

KG<br />

11410 Rexetin Paroxetinum Film-coated tablets 20 mg Chemical Works of Gedeon<br />

Richter Ltd.<br />

30/10/05<br />

31/12/08<br />

31/07/04<br />

30/09/04<br />

30/01/05<br />

31/12/08<br />

11411 Rexorubia Granules Lehning Laboratoires 31/12/08<br />

11412 Rezorcyna BUFA b.v. Pharmaceutical<br />

Products<br />

24/11/06<br />

11413 Rezorcyna Farm-Impex s.j., Gliwice 24/11/06<br />

11414 Rezorcyna Pharma Cosmetic, Kraków 24/11/06<br />

11415 Rezorcyna Pharma Zentrale 24/11/06


EN<br />

1242 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11416 Rezorcyna PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

11417 Rh0GAM poddany ultrafiltracji Anti-D (rh)<br />

immunoglobulinum<br />

Solution for<br />

intramuscular<br />

injection<br />

0.3 mg<br />

(1500 j.m.)<br />

Ortho-Clinical Diagnostic,<br />

Inc.<br />

11418 Rhelax Syrup Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

11419 RHEOMACRODEX 10 % z<br />

Chlorkiem Sodu<br />

Dextranum 10 % +<br />

Natrii chloridum<br />

Solution for<br />

intravenous infusion<br />

11420 Rheotromb Urokinasum Lyophilisate for<br />

intramuscular<br />

injection or infusion<br />

11421 Rhesogamma P Immunoglobulinum<br />

Humanum Antu Rh —<br />

D<br />

11422 Rhesogamma P Immunoglobulinum<br />

Humanum Antu Rh —<br />

D<br />

Solution for<br />

intramuscular<br />

injection<br />

Solution for<br />

intramuscular<br />

injection<br />

100 mg/ml Lithuanian, Ice-Landic &<br />

Swedish Joint Stock Company<br />

Closed Corporation<br />

‘ILSANTA’<br />

24/11/06<br />

31/12/07<br />

30/10/05<br />

31/12/08<br />

500000 j.m. Curasan Pharma 31/12/07<br />

1 ml (nie mniej<br />

niz˙ 200 mcg<br />

(1000 j.m.))<br />

1,5 ml (nie<br />

mniej niz˙<br />

300 mcg<br />

(1500 j.m.))<br />

Centeon Pharma GmbH 31/12/08<br />

Centeon Pharma GmbH 31/12/08<br />

11423 Rheuma Denk Etofenamatum Gel 1 % E. Denk OHG 31/12/08<br />

11424 Rheuma-Heel Tablets Heel GmbH 31/12/08<br />

11425 Rheumanol Phenylbutazonum +<br />

Ramifenazonum<br />

Film-coated tablets 100mg +<br />

200mg<br />

Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

11426 Rheuma-Pasc tabletki Pascoe Pharmaceutische<br />

Preparate GmbH<br />

11427 Rheuma-Pasc-Forte krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

31/12/05<br />

30/11/05<br />

30/11/05<br />

11428 Rheumodoron 1 krople WELEDA 24/08/05<br />

11429 Rheumodoron 102A krople WELEDA 24/08/05<br />

11430 Rheumodoron 2 krople WELEDA 24/08/05<br />

11431 Rheumon Etofenamatum Cream 10 % Bayer AG 31/12/07<br />

11432 Rhin — Bac Preparat złoz˙ony Nasal stick Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

11433 Rhinafen Tablets 200mg<br />

ibuprofenu<br />

30mg<br />

chlorowodorku<br />

pseudoefedryny<br />

Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

30/10/05<br />

31/12/08<br />

11434 Rhinallergy Tablets Laboratoires BOIRON 27/09/07<br />

11435 Rhinathiol Carbocisteinum Granules for oral<br />

suspension<br />

750 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

11436 Rhinathiol Carbocisteinum Syrup 100 mg/5ml Synthelabo Group.<br />

Laboratoires Synthelabo<br />

11437 Rhinathiol Carbocisteinum Syrup 750 mg/15ml Synthelabo Group.<br />

Laboratoires Synthelabo<br />

11438 Rhinazin Naphazolinum Nasal drops, solution 1 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/04<br />

31/12/04<br />

31/12/04<br />

31/12/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1243<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11439 Rhiniffa T Szczepionka dla s´wiń<br />

przeciw zakaz´nemu<br />

zanikowemu zapaleniu<br />

nosa<br />

Liquid for veterinary<br />

use<br />

Merial 9/06/05<br />

11440 Rhinocort Budesonidum Nasal spray, solution 50 mcg/dawke˛ AstraZeneca AB 30/06/04<br />

11441 Rhinocort Budesonidum Nasal spray, water<br />

suspension<br />

11442 Rhinocort Budesonidum Nasal spray, water<br />

suspension<br />

11443 Rhinoflux Oxymetazolinum +<br />

Flumethazonum<br />

11444 Rhinophenazol Acidum boricum +<br />

Antazolinum +<br />

Naphazolinum<br />

11445 Rhinophenazol Antazolinum +<br />

Naphazolinum<br />

11446 Rhinopront Carbinoxaminum +<br />

Phenylephrinum<br />

11447 Rhinopront Carbinoxaminum +<br />

Phenylpropanolaminum<br />

11448 Rhinotek Inaktywowana<br />

szczepionka dla s´wiń<br />

przeciw zakaz´nemu<br />

zanikowemu zapaleniu<br />

nosa<br />

32 mcg/dawke˛<br />

donosowa˛<br />

64 mcg/dawke˛<br />

donosowa˛<br />

AstraZeneca AB 30/11/04<br />

AstraZeneca AB 30/11/04<br />

Nasal drops Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Eye drops, solution Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Nasal drops, solution (5mg +<br />

0,25mg)/ml<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Capsules Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

Suspension Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

Suspension for veterinary<br />

use<br />

31/12/08<br />

30/11/05<br />

31/12/05<br />

30/09/04<br />

30/09/04<br />

Biowet Puławy 31/12/08<br />

11449 Rhinoxym Oxymetazolinum Drops 0,03 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

11450 Rhinoxym Forte Oxymetazolinum Drops Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

11451 Rhinoxymgel Oxymetazolinum Gel 0,03 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

11452 Rhinoxymgel — Forte Oxymetazolinum Gel 0,05 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

11453 Rhododendron Complexe nr 42 Drops Lehning Laboratoires 24/01/07<br />

11454 Rhododendroneel S Drops Heel GmbH 31/12/08<br />

11455 Rhus toxicodendron complexe<br />

nr 80<br />

11456 Rhus toxicodendron compose<br />

krople<br />

Drops Lehning Laboratoires 24/01/07<br />

Dolisos Laboratoires 31/12/08<br />

11457 Rhus toxicodendron Pentarkan Drops DHU-Arzneimittel GmbH &<br />

Co.KG<br />

11458 Rhus-Dagomed 6 bóle<br />

mie˛s´niowo-stawowe<br />

11459 Rhusionormin Surowica przeciw<br />

róz˙ycy<br />

11460 Riamet Artemetherum +<br />

Lumefantrinum<br />

Liquid for veterinary<br />

use<br />

Tablets 20mg +<br />

120mg<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

Drwalewskie Zakłady Przem.<br />

Biowet<br />

19/03/06<br />

31/01/06<br />

31/12/08<br />

Novartis Pharma AG 22/02/06


EN<br />

1244 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11461 Ribavir Ribavirinum Capsules 200 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

11462 Ribis Risedronatum Film-coated tablets 5 mg Adamed Sp. z o.o. 31/12/08<br />

11463 Ribomunyl Granules for oral<br />

solution<br />

Pierre Fabre Medicament 30/09/04<br />

11464 Ribomunyl Tablets Pierre Fabre Medicament 30/09/04<br />

11465 Ribomunyl Tablets Pierre Fabre Medicament 30/09/04<br />

11466 Rifamazid Isoniazidum +<br />

Rifampicinum<br />

11467 Rifamazid Isoniazidum +<br />

Rifampicinum<br />

Capsules 100mg +<br />

150 mg<br />

Capsules 150mg +<br />

300 mg<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11468 Rifampicyna Rifampicinum Capsules 150 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11469 Rifampicyna Rifampicinum Capsules 300 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

11470 Riflux Ranitidinum Effervescent tablets 75 mg Polfarmex S.A. 27/09/06<br />

11471 Riflux, Ranigasan Ranitidinum Effervescent tablets 150 mg Polfarmex S.A 23/11/05<br />

11472 Riflux, Ranigasan Ranitidinum Film-coated tablets 150 mg Polfarmex S.A 31/12/05<br />

11474 Rigevidon Ethinylestradiolum +<br />

Levonorgestrelum<br />

11473 Rigevidon Ethinylestradiolum +<br />

Levonorgestrelum<br />

11475 Rigevidon 21+7 Ethinylestradiolum +<br />

Levonorgestralum<br />

11476 Rilexine 200 LC Cefalexinum Intramammary<br />

suspension<br />

Film-coated tablets 0,15mg +<br />

0,03mg<br />

Tablets 30mcg +<br />

150mcg<br />

Film-coated tablets (0,03 mg +<br />

0,015 mg)<br />

for veterinary<br />

use<br />

11477 Rilexine 300 Cefalexinum Tablet for veterinary<br />

use<br />

11478 Rilexine 600 Cefalexinum Tablet for veterinary<br />

use<br />

11479 Rilexine 75 Cefalexinum Tablet for veterinary<br />

use<br />

Gedeon Richter Ltd. 25/01/06<br />

Gedeon Richter Ltd. 31/05/04<br />

Chemical Works of Gedeon<br />

Richter Ltd.<br />

31/12/08<br />

Virbac SA 31/12/08<br />

Virbac S.A. 22/11/06<br />

Virbac S.A. 22/11/06<br />

Virbac S.A. 22/11/06<br />

11480 Rilutek Riluzolum Film-coated tablets 50 mg Aventis Pharma S.A. 31/12/08<br />

11481 Rimadyl Iniekcja Karprofen Solution for veterinary<br />

use<br />

11482 Rimadyl Palatable Tabs 100 Karprofen Tablets for veterinary<br />

use<br />

11483 Rimadyl Palatable Tabs 20 Karprofen Tablets for veterinary<br />

use<br />

11484 Rimadyl Palatable Tabs 50 Karprofen Tablets for veterinary<br />

use<br />

11485 Rimadyl Tabletki 20 Karprofen Tablet for veterinary<br />

use<br />

11486 Rimadyl Tabletki 50 Karprofen Tablet for veterinary<br />

use<br />

Pfizer 20/04/04<br />

Pfizer 31/12/08<br />

Pfizer 31/12/08<br />

Pfizer 31/12/08<br />

Pfizer 20/04/04<br />

Pfizer 20/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1245<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11487 Rimevax Morbilli, live attenuated Lyophilisate for<br />

solution for injection<br />

11488 Rimevax Morbilli, live attenuated Lyophilisate for<br />

solution for injection<br />

11489 Rimevax Morbilli, live attenuated Lyophilisate for<br />

solution for injection<br />

11490 Rimevax Morbilli, live attenuated Lyophilisate for<br />

solution for injection<br />

11491 Ring N Acidum acetylsalicylicum<br />

+ Acidum ascorbicum<br />

(vit C) + Coffeinum<br />

11492 Rinipravac-DT Inaktywowana<br />

szczepionka dla s´wiń<br />

przeciw zakaz´nemu<br />

zanikowemu zapaleniu<br />

nosa<br />

10 dawek SmithKline Beecham<br />

Biologicals<br />

1000 TCID 50/<br />

dawke˛<br />

SmithKline Beecham<br />

Biologicals<br />

5 dawek SmithKline Beecham<br />

Biologicals<br />

50 dawek SmithKline Beecham<br />

Biologicals<br />

Tablets Heinrich Mack Nachf. GmbH<br />

& C0. KG a company of<br />

Pfizer Group<br />

Emulsion for veterinary<br />

use<br />

11493 Rintal 10 % zawiesina Febantel Suspension for veterinary<br />

use<br />

11494 Rintal 2,4 % Premiks Febantel Premix for veterinary<br />

use<br />

11495 Rintal Plus Febantel, Metrifonat Paste for veterinary<br />

use<br />

11496 Risaxyl Cholini salicylas +<br />

Lidocainum +<br />

Xylometazolinum<br />

29/02/04<br />

29/02/04<br />

29/02/04<br />

29/02/04<br />

31/07/04<br />

Laboratorios Hipra S.A. 24/05/07<br />

Bayer 31/12/08<br />

Bayer 31/12/08<br />

Bayer 31/12/08<br />

Nasal drops, solution ICN Polfa Rzeszów S.A. 31/12/05<br />

11497 Riselle 17 ß estradiolum Subcutaneous implant 25 mg Organon 31/12/08<br />

11498 Risnia 1 Risperidonum Film-coated tablets 1 mg Cipla Ltd. 31/12/08<br />

11499 Risnia 2 Risperidonum Film-coated tablets 2 mg Cipla Ltd. 31/12/08<br />

11500 Risnia 3 Risperidonum Film-coated tablets 3 mg Cipla Ltd. 31/12/08<br />

11501 Risnia 4 Risperidonum Film-coated tablets 4 mg Cipla Ltd. 31/12/08<br />

11502 Risperatio 1 Risperidonum Film-coated tablets 1 mg ratiopharm GmbH 31/12/08<br />

11503 Risperatio 2 Risperidonum Film-coated tablets 2 mg ratiopharm GmbH 31/12/08<br />

11504 Risperatio 3 Risperidonum Film-coated tablets 3 mg ratiopharm GmbH 31/12/08<br />

11505 Risperatio 4 Risperidonum Film-coated tablets 4 mg ratiopharm GmbH 31/12/08<br />

11506 Risperidon Risperidonum Film-coated tablets 1mg, 2 mg,<br />

3mg , 4mg<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

11507 Risperidone Risperidonum Film-coated tablets 4 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

11508 Risperidone Risperidonum Film-coated tablets 3 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

11509 Risperidone Risperidonum Film-coated tablets 2 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

11510 Risperidone Risperidonum Film-coated tablets 1 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

11511 RISPERIDONE 1 mg Risperidonum Film-coated tablets 1 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

1246 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11512 RISPERIDONE 2 mg Risperidonum Film-coated tablets 2 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

11513 RISPERIDONE 3 mg Risperidonum Film-coated tablets 3 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

11514 RISPERIDONE 4 mg Risperidonum Film-coated tablets 4 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

11515 Rispogen Risperidonum Tablets 1 mg, 2 mg,<br />

3 mg, 4 mg<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

GENEXO Sp.z.o.o Warszawa 31/12/08<br />

11517 Rispolept Risperidonum Film-coated tablets 1 mg Janssen-Cilag N.V. 29/05/06<br />

11518 Rispolept Risperidonum Film-coated tablets 2 mg Janssen-Cilag N.V. 29/05/06<br />

11519 Rispolept Risperidonum Film-coated tablets 3 mg Janssen-Cilag N.V. 29/05/06<br />

11520 Rispolept Risperidonum Film-coated tablets 4 mg Janssen-Cilag N.V. 29/05/06<br />

11521 Rispolept Risperidonum Film-coated tablets 6 mg Janssen Pharmaceutica 30/09/07<br />

11516 Rispolept Risperidonum Oral solution 1 mg/ml Janssen Pharmaceutica N.V. 31/08/04<br />

11522 Rivanol 0,1 % Ethacridini lactas Coutanous liquid 1 mg/g Prolab s.c. — Farmaceutyczne<br />

Przedsie˛biorstwo<br />

Produkcyjno-Analityczno-<br />

Handlowe s.c. Paterek<br />

11523 Rivanol 0.1 % roztwór Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

30/01/05<br />

24/10/05<br />

11524 Rivanolum Ethacridini lactas Tablets 100 mg ICN Polfa Rzeszów S.A. 30/10/05<br />

11525 Rivanolum -M 0.1 Maggie, Warszawa 5/09/05<br />

11526 Rivanolum roztwór 0.1 % Ethacridini lactas Liquid 0,10 % Zakład Farmaceutyczny<br />

Amara, Kraków<br />

11527 Rivasen Ethacridinum Gel 0,005 g / 1 g ZIAJA Ltd. Zakład<br />

Produkcyjny Gdańsk<br />

11528 Rivel Ethacridini lactas Gel 5 mg/g EMO Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych doc dr hab..<br />

Farm. Michał Oginski<br />

11529 Rivotril Clonazepamum Solution for injection 1 mg/1 ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

11530 Rivotril Clonazepamum Tablets 0.5 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

11531 Rivotril Clonazepamum Tablets 2 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

11532 Rixative Sennae folium extractum Oral gel 84 mg/g Santana" N. BALANOS S.A.,<br />

Grecja<br />

11533 Roaccutane Isotretinoinum Capsules 10 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

11534 Roaccutane Isotretinoinum Capsules 20 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

19/03/07<br />

31/12/08<br />

9/08/06<br />

31/05/04<br />

31/05/04<br />

31/05/04<br />

31/12/08<br />

31/07/04<br />

31/07/04<br />

11535 Robinia comp. Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

11536 Robinia comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

11537 Robitussin Antitussicum Dextromethorphanum Syrup 7.5 mg/5ml Whitehall Laboratories Ltd. 31/08/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1247<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11538 Robitussin Expectorans Guaifenesinum Syrup 100 mg/5ml Whitehall Laboratories Ltd. 31/08/05<br />

11539 Robitussin Junior Dextromethorphanum Syrup 3.75 mg/5 ml Whitehall Laboratories Ltd. 6/07/05<br />

11540 Roborante Peptydy kazainowe,<br />

fosforo-wapniowy<br />

chlorek cholin,<br />

witamina b12<br />

Solution for veterinary<br />

use<br />

Laboratorios Calier S.A. 31/12/08<br />

11541 Rocaltrol Calcitriolum Capsules 0.25 mcg Hoffmann La Roche Ltd.<br />

Bazylea<br />

11542 Rocaltrol Calcitriolum Capsules 0.5 mcg Hoffmann La Roche Ltd.<br />

Bazylea<br />

11543 Rocephin Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

11544 Rocephin Ceftriaxonum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

11545 Rodanol S Nabumetonum Tablets for oral<br />

suspension<br />

11546 Roferon-A Interferonum alfa-2a Solution for injection 18 mln. j.m./<br />

3ml<br />

11547 Roferon-A Interferonum alfa-2a Solution for<br />

subcutaneous<br />

injection<br />

11548 Roferon-A Interferonum alfa-2a Solution for<br />

subcutaneous<br />

injection<br />

11549 Roferon-A Interferonum alfa-2a Solution for<br />

subcutaneous<br />

injection<br />

11550 Roferon-A Interferonum alfa-2a Solution for<br />

subcutaneous<br />

injection<br />

11551 Roferon-A Interferonum alfa-2a Solution for<br />

subcutanous injection<br />

0.25 g Hoffmann La Roche Ltd.<br />

Bazylea<br />

1 g Hoffmann La Roche Ltd.<br />

Bazylea<br />

31/05/04<br />

31/05/04<br />

30/04/04<br />

30/04/04<br />

1 g Lek Pharmaceuticals d.d. 14/12/05<br />

3 mln. j.m./<br />

0,5 ml<br />

4.5 mln. j.m./<br />

0,5 ml<br />

6 mln. j.m./<br />

0,5 ml<br />

9 mln. j.m./<br />

0,5 ml<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

Hoffmann La Roche Ltd.<br />

Bazylea<br />

30 mln j.m./ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

16/10/06<br />

31/01/05<br />

31/01/05<br />

31/01/05<br />

31/01/05<br />

06-06-31<br />

11552 Roglit Rosiglitazonum Film-coated tablets 4 mg , 8 mg GENEXO Sp.z.o.o Warszawa 31/12/08<br />

11553 Rohypnol Flunitrazepamum Film-coated tablets 1 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

31/12/07<br />

11554 Roletra 10 Loratadinum Tablets 10 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

11556 Rolicyn Roxithromycinum Film-coated tablets 100 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11557 Rolicyn Roxithromycinum Film-coated tablets 150 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11558 Rolicyn Roxithromycinum Film-coated tablets 50 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11555 Rolicyn Roxithromycinum Granules for oral<br />

solution<br />

11559 Rometar 2 % Chlorowodorek<br />

ksylazyny<br />

Solution for veterinary<br />

use<br />

11560 Ronaxan 100 Doxycyclinum Tablet for veterinary<br />

use<br />

50 mg / 5 ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12/10/05<br />

12/10/05<br />

12/10/05<br />

31/12/08<br />

Spofa 7/05/04<br />

Merial 7/05/06


EN<br />

1248 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11561 Ronaxan 20 Doxycyclinum Tablet for veterinary<br />

use<br />

11562 Ronaxan 20 % Doxycyclinum Powder for veterinary<br />

use<br />

Merial 7/06/06<br />

Merial 7/05/06<br />

11563 Ronton Ethosuximidum Syrup 250 mg/5 g ICN Polfa Rzeszów S.A. 31/12/05<br />

11564 Roseneisen/Graphit Granules WALA-Heilmittel GmbH 24/05/07<br />

11565 Rosmarinus complexe nr 24 Drops Lehning Laboratoires 31/03/06<br />

11566 Rota TS 100 Trimethoprium +<br />

Sulphadiazinum<br />

11567 Rota TS 500 Trimethoprium +<br />

Sulphadiazinum<br />

Tablet for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Vetoquinol S.A. 12/03/06<br />

Vetoquinol S.A. 12/03/06<br />

11568 Rotadin Loratadinum Syrup 1 mg/ml Egis Pharmaceuticals Ltd. 27/06/07<br />

11569 Rotadin Loratadinum Tablets 10 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

11570 Rotavec Corona szczepionka dla bydła<br />

przeciwko zakaz˙eniom<br />

wywoływanym przez<br />

rotawirus, koronawirus<br />

i e-coli<br />

11571 Rouvax Morbilli, live attenuated Lyophilisate for<br />

solution for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

11572 Rouvax Morbilli, live attenuated Lyophilisate for<br />

solution for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

Emulsion for veterinary<br />

use<br />

31/12/08<br />

Schering Plough 31/12/08<br />

1 dawka Aventis Pasteur S.A. 29/02/04<br />

10 dawek Aventis Pasteur S.A. 29/02/04<br />

11574 Rovamycine Spiramycinum Film-coated tablets 1,5 mln j.m. Rhône-Poulenc Rorer Specia 31/05/04<br />

11575 Rovamycine Spiramycinum Film-coated tablets 3 mln j.m. Rhône-Poulenc Rorer Specia 12/12/06<br />

11576 Rovamycine Spiramycinum Film-coated tablets 3 mln j.m. Rhône-Poulenc Rorer Sp.<br />

z o.o.<br />

11573 Rovamycine Spiramycinum Powder for solution<br />

for intravenous<br />

infusion<br />

12/12/06<br />

1,5 mln j.m. Rhône-Poulenc Rorer Specia 12/12/06<br />

11577 Rovenal® 100 Roxithromycinum Film-coated tablets 100 mg Leciva a.s. 31/12/08<br />

11578 Rovenal® 150 Roxithromycinum Film-coated tablets 150 mg Leciva a.s. 31/12/08<br />

11579 Rowachol Preparat złoz˙ony Capsules, soft Rowa-Wagner GmbH and Co.<br />

KG<br />

11580 Rowachol Preparat złoz˙ony Oral drops Rowa-Wagner GmbH and Co.<br />

KG<br />

11581 Rowatinex Preparat złoz˙ony Capsules Rowa-Wagner GmbH and Co.<br />

KG<br />

11582 Rowatinex Preparat złoz˙ony Oral drops Rowa-Wagner GmbH and Co.<br />

KG<br />

10/05/06<br />

10/05/06<br />

31/10/04<br />

31/10/04<br />

11583 Roxee 150 Roxithromycinum Film-coated tablets 150 mg Cipla Ltd. 31/12/08<br />

11584 Roxee 300 Roxithromycinum Film-coated tablets 300 mg Cipla Ltd. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1249<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11585 Roxiratio Roxithromycinum Film-coated tablets 150 mg ratiopharm GmbH 31/12/08<br />

11586 Roxitron Roxithromycinum Film-coated tablets 150 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

11587 Rozalin Azithromycinum Capsules 125 mg Adamed Sp. z o.o. 31/12/08<br />

11588 Rozalin Azithromycinum Capsules 250 mg Adamed Sp. z o.o. 31/12/08<br />

11589 Rozalin Azithromycinum Capsules 500 mg Adamed Sp. z o.o. 31/12/08<br />

11590 Rozex Metronidazolum Cream 7.5 mg/g Laboratoires Galderma S.A.<br />

Tour Europlaza<br />

11591 Rozex Metronidazolum Gel 7.5 mg/g Laboratoires Galderma S.A.<br />

Tour Europlaza<br />

11592 Roztwory do testów<br />

punktowych i skaryfikacyjnych<br />

11593 Roztwory testowe Bencard<br />

stosowane w diagnostyce<br />

alergii<br />

Solution Allergopharma Joachim<br />

Ganzer KG<br />

Solution for skin test<br />

prick<br />

11594 Roztwór 0,9 % Chlorku Sodu Natrii chloridum Solution for injection<br />

and infusion<br />

11595 Roztwór do testów<br />

prowokacyjnych<br />

Allergopharma<br />

11596 Roztwór do testów<br />

s´ródskórnych Allergopharma<br />

11597 Roztwór Elkintona nr 1 Kalii chloridum + Natrii<br />

chloridum<br />

11598 Roztwór Elkintona nr 2 Kalii chloridum + Natrii<br />

chloridum<br />

11599 Roztwór hibitanu 0.2 % w<br />

70 % etanolu<br />

Powder and solvent<br />

for solution<br />

Powder and solvent<br />

for solution<br />

Concentrate for<br />

solution for infusion<br />

Concentrate for<br />

solution for infusion<br />

15/11/06<br />

15/11/06<br />

31/03/04<br />

Allergy Therapeutics Limited 14/11/06<br />

Zakład Produkcji Sprze˛tu<br />

Medycznego RAVIMED Sp.<br />

z o.o.<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Allergopharma Joachim<br />

Ganzer KG<br />

Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

4/07/07<br />

4/07/07<br />

31/01/06<br />

31/01/06<br />

Galenus, Rzeszów 31/01/06<br />

11600 Roztwór propolisu 7 % Liquid Barć — Pasieka im. ks. dr<br />

Henryka Ostacha<br />

11601 Roztwór Ringera Calcii chloridum + Kalii<br />

chloridum + Natrii<br />

chloridum<br />

31/12/04<br />

Solution for infusion B. Braun Melsungen AG 13/09/06<br />

11602 Roztwór rywanolu 0,1 % Ethacridini lactas Solution 0.1 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

11603 Roztwór wodny jodu Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

31/12/06<br />

28/02/06<br />

11604 Rte˛ciowy aminochlorek Pharma Cosmetic, Kraków 31/12/08<br />

11605 Rte˛ciowy tlenek z˙ółty Hydrargyri oxydum<br />

flavum<br />

11606 Rte˛ć Hydrargyrum Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

Pharma Zentrale 30/06/06<br />

11607 Rub-Arom Preparat złoz˙ony Ointment Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/10/05<br />

14/09/05<br />

11608 Rubi fruticosi folium Herb Z.K.Z. FLOS, Mokrsko 31/12/08<br />

11609 Rubia complexe nr 3 Lehning Laboratoires 31/03/06


EN<br />

1250 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11610 Rubital Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

11611 Rubital — Compositum Althaeae sirupus +<br />

Ephedrinum + Rubi<br />

sirupus<br />

Syrup 6.5 mg/5ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

11612 Rubital Forte Althaeae radix Syrup 381 mg/5ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

7/05/06<br />

7/05/06<br />

31/07/05<br />

11613 Rudistrol Cream Laboratoires BOIRON 31/12/07<br />

11614 Rudivax Rubella, live attenuated Lyophilisate for<br />

solution for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

11615 Rudivax Rubella, live attenuated Lyophilisate for<br />

solution for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

1 dawka Aventis Pasteur S.A. 29/02/04<br />

10 dawek Aventis Pasteur S.A. 29/02/04<br />

11616 Rudotel Medazepamum Tablets 10 mg AWD.pharma GmbH & Co.<br />

KG<br />

31/12/04<br />

11618 Rulid Roxithromycinum Film-coated tablets 100 mg Laboratoires Roussel Diamant 31/05/05<br />

11619 Rulid Roxithromycinum Film-coated tablets 150 mg Laboratories Roussel 30/04/04<br />

11620 Rulid Roxithromycinum Film-coated tablets 50 mg Laboratoires Roussel Diamant 31/05/05<br />

11617 Rulid Roxithromycinum Tablets for oral<br />

suspension<br />

50 mg Laboratoires Roussel Diamant 31/12/08<br />

11621 Rusarut C Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

11622 Ruscolan Ruscogenin Rectal ointment 8 mg/g Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

11623 Ruscolan Tablets 120 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

11624 Rusedal Medazepamum Tablets 10 mg Oranienburger Pharmawerk<br />

GmbH<br />

11625 Rusedal Medazepanum Film-coated tablets 10 mg Oranienburger Pharmawerk<br />

GmbH<br />

11627 Ruskorex Ruscogenin +<br />

Tetracainum<br />

11626 Ruskorex Ruscogenin +<br />

Tetracainum<br />

Ointment (10mg +<br />

10mg)/g<br />

Suppository (25mg +<br />

25mg)/2g<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

15/03/06<br />

27/06/07<br />

30/06/04<br />

30/06/04<br />

17/01/07<br />

25/10/06<br />

11628 Rutacid Hydrotalcitum Chewable tablets 500 mg Krka d.d., Novo mesto 25/10/06<br />

11629 Rutinacea Forte Acidum ascorbicum<br />

+Rutinum<br />

11630 Rutinosal c Salicis cortex + Rutinum<br />

+ Vitaminum C<br />

11631 Rutinoscorbin Acidum ascorbicum (vit<br />

C) + Rutosidum<br />

Tablets 50 mg +<br />

200 mg<br />

Tablets 300 mg +<br />

20 mg +<br />

40 mg<br />

Film-coated tablets 100mg +<br />

25mg<br />

Aflofarm 31/12/08<br />

Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

11632 Rutinoscorbin Junior Preparat złoz˙ony Buccal tablets GlaxoSmithKline<br />

Pharmaceuticals Spółka<br />

Akcyjna<br />

31/12/08<br />

31/12/05<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1251<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11633 Rutinoscorbin Plus Film-coated tablets GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

11634 Rutinoven Troxerutinum Gel 20 mg/g R & C — Przedsie˛biorstwo<br />

Farmaceutyczne s.c.<br />

11635 Rutokalc Acidum ascorbicum,<br />

Calcium, Rutosidum<br />

Effervescent tablets 100 mg +<br />

300 mg +<br />

50 mg<br />

31/12/08<br />

31/01/06<br />

N.P. Pharma Sp. z o.o. 31/12/08<br />

11636 Rutoven Troxerutinum Film-coated tablets 0.15 g Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

11637 Rutoven Troxerutinum Gel for external use 20 mg/g Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

11639 Rutovit C Acidum ascorbicum<br />

(vit C) + Rutosidum<br />

11638 Rutovit C Acidum ascorbicum<br />

(vit C) + Rutosidum<br />

11640 Rutovit C Forte Acidum ascorbicum<br />

(vit C) + Rutosidum<br />

11641 Ruvax Szczepionka dla s´wiń<br />

przeciw róz˙ycy<br />

Film-coated tablets 100mg +<br />

25mg<br />

powder for solution 50mg +<br />

12,5mg<br />

Film-coated tablets 500mg +<br />

25mg<br />

Liquid for veterinary<br />

use<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/10/05<br />

30/10/05<br />

31/01/05<br />

11/01/06<br />

11/01/06<br />

Merial 9/06/05<br />

11642 Rybasol Omega-3-trójglicerydy Capsules WIKI Norre Lokke 30/11/04<br />

11643 Rythmodan Disopyramidum Capsules 100 mg Laboratories Roussel 30/06/04<br />

11644 Rytmonorm Propafenonum Solution for injection 3.5 mg/ml Abbott GmbH & Co KG 31/05/04<br />

11645 Rytmonorm 150 Propafenonum Film-coated tablets 150 mg Abbott GmbH & Co KG 31/05/04<br />

11646 Rytmonorm 300 Propafenonum Film-coated tablets 300 mg Abbott GmbH & Co KG 31/05/04<br />

11647 Rywanol 0.1 % Hasco-Lek, Wrocław 9/03/06<br />

11648 Rzewex Rhei radix pulvis Tablets 0.336 g Herbapol Łódz´ S.A. 31/12/08<br />

11649 Sabal-Homaccord Amp. Heel GmbH 31/12/08<br />

11650 Sabal-Homaccord Drops Heel GmbH 31/12/08<br />

11651 Sabiprost Sabal serrulatae fructus<br />

extractum siccum<br />

11652 Sabiprost-u Sabal serrulatae fructus<br />

extractum siccum,<br />

Urticae radix extractum<br />

siccum<br />

Capsules, hard 160 mg Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Capsules, hard (160mg +<br />

200mg)<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

31/12/08<br />

11654 Sabril Vigabatrinum Film-coated tablets 500 mg Marion Merrell Ltd. 31/12/04<br />

11653 Sabril Vigabatrinum Powder for oral<br />

solution<br />

500 mg Patheon France S.A. 24/08/05<br />

11655 Saccharinum Saccharinum Tablets 12 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

11656 Sachodent Cholini salicylas +<br />

Cetalkonium chloratum<br />

Dental gel 87,1 mg<br />

salicylanu<br />

choliny ;<br />

0,1 mg chlorku<br />

cetalkoniowego<br />

/ 1 g<br />

ZIAJA Ltd. Zakład<br />

Produkcyjny Gdańsk<br />

31/01/06<br />

31/12/08<br />

11657 Sachol Cholini salicylas Oromucosal solution 87.1 mg/g ICN Polfa Rzeszów S.A. 31/12/05


EN<br />

1252 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11658 Sachol Cholini salicylas Syrup 100 mg/g ICN Polfa Rzeszów S.A. 31/01/06<br />

11659 Sachol z˙el stomatologiczny Cetalkonii chloridum +<br />

Cholini salicylas<br />

11660 Sacox 120 Salinomycyny sól<br />

sodowa<br />

Oromucosal gel (0,1mg +<br />

87.1 mg)/g<br />

Premix for veterinary<br />

use<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

Intervet International B.V. 6/12/04<br />

11661 Sadamin Xantinoli nicotinas Solution for injection 150 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

11662 Sadamin Xantinoli nicotinas Tablets 150 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

11663 Sadamin prolongatum Xantinoli nicotinas Film-coated, prologed<br />

release tablets<br />

11664 Saizen 10 Somatropinum Powder and solvent<br />

for solution for<br />

injection<br />

11665 Saizen 24 Somatropinum Powder and solvent<br />

for solution for<br />

subcutaneous<br />

injection<br />

11666 Saizen 4 Somatropinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

11667 Sal Carolinum factitium<br />

effervescens<br />

500 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/05<br />

30/11/05<br />

30/11/05<br />

10 j.m. Laboratoires Serono S.A. 14/09/05<br />

24 j.m. Industria Farmaceutica<br />

Serono Sp. A.<br />

4 j.m.<br />

(1.33 mg)<br />

31/07/04<br />

Laboratories Serono S.A. 30/06/04<br />

Effervescent tablets Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

11668 Sal Ems Artificiale Effervescent tablets Farmaceutyczno —<br />

Chemiczna Spółdzielnia Pracy<br />

Galenus<br />

11669 Sal Ems factitium Effervescent tablets Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

11670 Sal Vichy factitium Effervescent tablets Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

11671 Sal. Ems artificiale Preparat złoz˙ony Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/01/06<br />

31/07/05<br />

31/01/06<br />

31/01/06<br />

31/12/05<br />

11672 Sal. Ems artificiale (factitium) Granules Farmina Sp. z o.o. 31/12/04<br />

11673 Salagen Pilocarpinum Film-coated tablets 5 mg Chiron B.V. 31/03/04<br />

11674 Salamol EB Salbutamolum Pressurised inhalation,<br />

suspension<br />

11675 Salamol EB Salbutamolum Pressurised inhalation,<br />

suspension<br />

11676 Salazopyrin EN Sulfasalazinum Gastro-resistant<br />

tablets<br />

11678 Salbutamol Salbutamolum Pressurised inhalation,<br />

suspension<br />

100 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

100 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

Norton Healthcare Ltd. 31/01/05<br />

Norton Healthcare Ltd. 31/01/05<br />

500 mg Pharmacia A.B. 8/02/06<br />

100 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

11679 Salbutamol Salbutamolum Solution for injection 0.5 mg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

11677 Salbutamol Salbutamolum Spray , suspention<br />

(chlorofluorocarbons<br />

free)<br />

100 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/12/05<br />

31/12/05<br />

31/12/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1253<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11680 Salbutamol Salbutamolum Syrup 2 mg/5 ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

11681 Salbutamol Salbutamolum Syrup 2 mg/5 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

11682 Salbutamol Salbutamolum Tablets 2 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

11683 Salbutamol Salbutamolum Tablets 4 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

11684 Salbuvent Salbutamolum Pressurised inhalation,<br />

suspension<br />

100 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

Schering AG 31/12/04<br />

11685 Saldiam Diethylamini salicylas Cream 100 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

11686 Saldiam Diethylamini salicylas Gel 100 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

11687 Salenvac Szczepionka przeciw<br />

zakaz˙eniom<br />

Salmonella enteritidis<br />

dla kurcza˛t.<br />

11688 Salenvac T szczepionka przeciwko<br />

zakaz´eniom salmonella<br />

enteritidis i salmonella<br />

typhimurium<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

30/10/05<br />

29/11/06<br />

Intervet International B.V. 8/09/05<br />

Intervet International 31/12/08<br />

11689 Salfazin Tablets Puritan's Pride, Incorporated 31/07/04<br />

11690 Salfuride 50 Nifursol Premix for veterinary<br />

use<br />

Solvay Pharmaceuticals 21/02/07<br />

11691 Salicortex Salicis cortex Tablets 330 mg Labofarm — Innowacyjno-<br />

Wdroz˙eniowe Laboratorium<br />

Farmaceutyczne<br />

11692 Salicylamid Zakłady Farmaceutyczne<br />

Polpharma SA, Starogard<br />

Gdański<br />

11693 Salicylol Acidum salicylicum +<br />

Ricini oleum<br />

Coutanous liquid (50mg +<br />

950mg) /g<br />

Profarm — Przedsie˛biorstwo<br />

Produkcji Farmaceutyczno-<br />

Kosmetycznej Sp. z o.o.<br />

11694 Saliderm — Gel Acidum salicylicum Gel 100 mg/g Profarm — Przedsie˛biorstwo<br />

Produkcji Farmaceutyczno-<br />

Kosmetycznej Sp. z o.o.<br />

11695 Salimag Tablets 681 mg Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

30/06/07<br />

19/11/07<br />

31/01/06<br />

31/01/06<br />

31/12/08<br />

11696 Salipax Fluoxetinum Capsules 20 mg Mepha AG 31/12/08<br />

11697 Salisal Salicis cortex extractum<br />

siccum<br />

Film-coated tablets 143 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

14/02/07<br />

11698 SALIX/RHUS comp. ampułki WALA-Heilmittel GmbH 19/03/05<br />

11699 SALIX/RHUS comp. granulki WALA-Heilmittel GmbH 19/03/05<br />

11700 Salixan Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

11701 Salixan C Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

11702 Salixan Junior Capsules, hard Herbapol — Lublin S.A. 31/12/08


EN<br />

1254 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11703 SalmAbic Inaktywowana<br />

szczepionka dla kur<br />

przeciw salmonelozie<br />

Water — oil emulsion for veterinary<br />

use<br />

ABIC Ltd. 31/12/08<br />

11704 Salmonella comp. krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

11705 Salmovir Szczepionka dla gołe˛bi<br />

przeciw salmonelozie i<br />

paramyksowirozie<br />

Emulsion for veterinary<br />

use<br />

30/11/05<br />

Biowet Puławy 15/11/05<br />

11706 Salofalk Mesalazinum Suppository 250 mg Dr Falk Pharma GmbH 30/04/04<br />

11707 Salofalk 250 Mesalazinum Gastro-resistant<br />

tablets<br />

11709 Salofalk 500 Mesalazinum Gastro-resistant<br />

tablets<br />

250 mg Dr Falk Pharma GmbH 31/03/04<br />

500 mg Dr Falk Pharma GmbH 31/03/04<br />

11708 Salofalk 500 Mesalazinum Suppository 500 mg Dr Falk Pharma GmbH 31/07/04<br />

11710 Salotannal Tablets Sanofi-Synthelabo Sp. z o.o. 31/12/08<br />

11711 Salpirin Acidum acetylsalicylicum Gastro-resistant<br />

tablets<br />

500 mg Polfarmex S.A 12/10/05<br />

11712 Saltoral Sole rehydratacyjne powder for solution Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/11/05<br />

11713 Salubrious siberian ginseng, Capsules 100 mg Power Health Prod. 31/12/08<br />

11714 Salumin Preparat ziołowy Oromucosal gel Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

11715 Salvasept Buccal tablets preparat<br />

złoz˙ony<br />

11716 Salvement Salemterolum Inhalation capsules 50<br />

mikrogramów<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

30/06/06<br />

31/12/08<br />

31/12/08<br />

11717 Salvequick Acidum salicylicum Pach Cederroth Iberica 31/07/04<br />

11718 Salvi Cal. E-G 24 Solution for<br />

intravenous infusion<br />

11719 Salvi Cal. E-G 40 Solution for<br />

intravenous infusion<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

11720 Salvia — Medac Mucinum Oromucosal spray 35 mg/ml Medac Gesellschaft für<br />

klinische Spezialpräparate<br />

mbH<br />

11721 Salviamin Hepar Solution for<br />

intravenous infusion<br />

Baxter Healthcare<br />

Corporation Clintec<br />

Parenteral S.A.<br />

31/07/04<br />

31/07/04<br />

31/12/08<br />

30/01/05<br />

11723 Salviasept Buccal tablets Herbapol — Lublin S.A. 30/06/07<br />

11722 Salviasept Liquid for external use<br />

and inhalation<br />

11725 Samezil Mesalazinum Gastro-resistant<br />

tablets<br />

11726 Samezil Mesalazinum Gastro-resistant<br />

tablets<br />

Herbapol Lublin S.A. 30/06/07<br />

400 mg KRKA Polska Sp. z o.o. 31/12/08<br />

800 mg KRKA Polska Sp. z o.o. 31/12/08<br />

11727 Samezil Mesalazinum Rectal suspension 2 g/50 ml KRKA Polska Sp. z o.o. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1255<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11728 Samezil Mesalazinum Rectal suspension 4 g/100 ml KRKA Polska Sp. z o.o. 31/12/08<br />

11724 Samezil Mesalazinum Suppository 500 mg KRKA Polska Sp. z o.o. 31/12/08<br />

11729 Sanaprox Naproxenum Tablets 250 mg Sanofi Winthrop-Gentilly 31/12/08<br />

11730 Sanaprox Naproxenum Tablets 500 mg Sanofi Winthrop-Gentilly 31/12/08<br />

11731 Sandimmun Ciclosporinum Concentrate for<br />

solution for<br />

intravenous infusion<br />

50 mg/ml Novartis Pharma AG 31/05/04<br />

11732 Sandimmun Neoral Ciclosporinum Capsules 100 mg Novartis Pharma AG 31/01/05<br />

11733 Sandimmun Neoral Ciclosporinum Capsules 25 mg Novartis Pharma AG 31/01/05<br />

11734 Sandimmun Neoral Ciclosporinum Capsules 50 mg Novartis Pharma AG 31/01/05<br />

11735 Sandimmun Neoral Ciclosporinum Gelatin capsules 10 mg Novartis Pharma AG 30/04/04<br />

11736 Sandimmun Neoral Ciclosporinum Oral solution 100 mg/ml Novartis Pharma AG 31/01/05<br />

11739 Sandoglobulin P Immunoglobulinum<br />

humanum<br />

11737 Sandoglobulin P Immunoglobulinum<br />

humanum<br />

11738 Sandoglobulin P Immunoglobulinum<br />

humanum<br />

Lyophilisate for<br />

intravenous infusion<br />

Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

1 g/50 ml ZLB Laboratorium<br />

Krwiodawstwa<br />

Szwajcarskiego Czerwonego<br />

Krzyz˙a<br />

3 g ZLB Laboratorium<br />

Krwiodawstwa<br />

Szwajcarskiego Czerwonego<br />

Krzyz˙a<br />

6 g ZLB Laboratorium<br />

Krwiodawstwa<br />

Szwajcarskiego Czerwonego<br />

Krzyz˙a<br />

31/12/07<br />

31/05/05<br />

31/05/05<br />

11740 Sandostatin Octreotidum Solution for injection 0.05 mg/1ml Novartis Pharma AG 30/04/04<br />

11741 Sandostatin Octreotidum Solution for injection 0.1 mg/1 ml Novartis Pharma AG 30/04/04<br />

11742 Sandostatin Octreotidum Solution for injection 0.2 mg/ml Novartis Pharma AG 30/04/04<br />

11743 Sandostatin LAR Octreotidum Microgranules and<br />

solvent for suspension<br />

for intramuscular<br />

injection<br />

11744 Sandostatin LAR Octreotidum Microgranules and<br />

solvent for suspension<br />

for intramuscular<br />

injection<br />

11745 Sandostatin LAR Octreotidum Microgranules and<br />

solvent for suspension<br />

for intramuscular<br />

injection<br />

10 mg Novartis Pharma AG 30/12/04<br />

20 mg Novartis Pharma AG 30/12/04<br />

30 mg Novartis Pharma AG 30/12/04<br />

11746 Sankombi D5 krople Sanum-Kehlbeck 31/12/05<br />

11747 Sannukehl Staph D5 iniekcje Sanum-Kehlbeck 31/12/05<br />

11748 Sanofil Preparat złoz˙ony Cutaneous spray Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

11749 Sanosvit Calcium Calcii glubionas + Calcii<br />

lactobionas<br />

Syrup 114 mg Ca++/<br />

5ml<br />

Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

30/10/05<br />

31/12/05<br />

11750 Santaherba Drops Lehning Laboratoires 31/10/05<br />

11751 Sanukehl Staph D6 krople Sanum-Kehlbeck 31/12/05


EN<br />

1256 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11752 Sanuvis iniekcje Sanum-Kehlbeck 31/12/05<br />

11753 Sanuvis krople Sanum-Kehlbeck 31/12/05<br />

11754 Sanval Zolpidemi tartas Film-coated tablets 10 mg Lek Pharmaceuticals d.d. 30/06/05<br />

11755 Sanval Zolpidemi tartas Film-coated tablets 5 mg Lek Pharmaceuticals d.d. 30/06/05<br />

11756 Saponarex Saponariae et Plantaginis<br />

extractum fluidum +<br />

Thymi extractum fluidum<br />

11757 Sapoven Hippocastani extractum<br />

siccum<br />

11758 Sapoven AT Benzocainum +<br />

Hippocastani semen<br />

extractum siccum +<br />

Troxerutinum<br />

11759 Sapoven t Hippocastani extractum<br />

spissum + Troxerutin<br />

11760 Sapoven T Hippocastani semen<br />

extractum siccum +<br />

Troxerutinum<br />

11761 Saridon Coffeinum +<br />

Paracetamolum +<br />

Propyphenazonum<br />

11762 SAROTHAMNUS comp.<br />

ampułki<br />

11763 SAROTHAMNUS comp.<br />

granulki<br />

Oral solution Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

Ointment 50 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Suppository (40mg +<br />

200mg+<br />

100mg)/2g<br />

Gel (100 mg +<br />

20 mg)/g<br />

Capsules, soft 100mg +<br />

200mg<br />

11764 Satural Calcii lactas gluconas Effervescent powder 208 mg Ca++/<br />

4g<br />

11765 Satural Calcii lactogluconas Effervescent powder 200 mg Ca++/<br />

4g<br />

11766 Satural GL Calcii glubionas + Calcii<br />

lactas gluconas<br />

11767 Savarix Benzocainum +<br />

Heparinum + Intractum<br />

Hippocastani<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/05/06<br />

30/06/07<br />

29/11/06<br />

30/09/07<br />

23/11/05<br />

Tablets Roche Consumer Health Ltd 31/05/04<br />

Effervescent powder 114 mg Ca++/<br />

4g<br />

Gel (10mg +<br />

500j.m. +<br />

50mg)/g<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

Polfarmex S.A 31/12/05<br />

Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

Byk-Mazovia Sp. z o.o. w<br />

Łyszkowicach<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

31/12/05<br />

31/12/05<br />

31/08/05<br />

11768 Scabiosa Compexe Nr 87 Liquid Lehning Laboratoires 24/05/07<br />

11769 Scaldex Preparat złoz˙ony Ointment Dermaphyt Sp. Z o.o.<br />

(Wadowice)<br />

11770 Scaldex Cutaneous spray Dermaphyt Sp. Z o.o.<br />

(Wadowice)<br />

11771 Scandonest 2 % Noradrenaline Mepivacainum +<br />

Norepinephrinum<br />

11772 Scandonest 2 % Special Mepivacainum +<br />

Norepinephrinum<br />

11773 Scandonest 3 % Sans Vasoconstricteur<br />

Solution for injection (20mg +<br />

0,01mg)/ml<br />

Solution for injection (20mg +<br />

0,01mg)/ml<br />

31/08/05<br />

16/05/07<br />

Septodont 30/11/04<br />

Septodont 31/01/05<br />

Mepivacainum Solution for injection 30 mg/ml Septodont 30/11/04<br />

11774 Scanoflox 10 % Oral Enrofloxacinum Solution for veterinary<br />

use<br />

Laboratorios Calier S.A. 8/05/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1257<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11775 Scanohepar Menbuton Solution for veterinary<br />

use<br />

11776 Scanomectin Iwermektyna Solution for veterinary<br />

use<br />

Laboratorios Calier SA 31/12/08<br />

Bomac 31/12/08<br />

11777 Schwef-Heel Drops Heel GmbH 31/12/08<br />

11778 Scilla comp. Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

11779 Scilla comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

11780 Sclerocalcine Tablets Lehning Laboratoires 31/12/08<br />

11782 Scopolan Butylscopolaminum Coated tablets 10 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

11781 Scopolan Butylscopolaminum Suppository 10 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

11783 Scopolan compositum Butylscopolaminum +<br />

Metamizolum natricum<br />

11784 Scorbolamid Acidum ascorbicum (vit<br />

C) + Rutosidum +<br />

Salicylamidum<br />

11785 Scorborutin Acidum ascorbicum,<br />

Rutosidum<br />

11786 ScourGuard 3 (K) Szczepionka dla krów<br />

przeciw biegunkom<br />

ciela˛t wywoływanym<br />

przez rotawirus<br />

bydle˛cy, koronawirus<br />

bydle˛cy oraz e szczepy<br />

E.coli<br />

Film-coated tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

Coated tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

Film-coated tablets 100 mg +<br />

25 mg<br />

Suspension for veterinary<br />

use<br />

31/07/05<br />

30/01/05<br />

31/01/06<br />

30/10/05<br />

Elanda S.C. 31/12/08<br />

Pfizer 30/06/04<br />

11787 Sea Kelp Tablets 400 mg Lifeplan Products Ltd. 31/10/04<br />

11788 Seal and Heal Acidum salicylicum Gel 125 mg/g SSL International plc. 31/05/04<br />

11789 Sebacil Pour — on Foksym Solution for veterinary<br />

use<br />

11790 Sebidin Acidum ascorbicum<br />

(vit C) + Chlorhexidinum<br />

11791 Sebidin Plus Acidum ascorbicum<br />

(vit C) + Chlorhexidinum<br />

Bayer 24/01/07<br />

Buccal tablet 50mg + 5mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Buccal tablets 75mg + 5mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

11792 Seboren Preparat ziołowy Coutanous liquid Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

11793 SECALE/GALENIT comp.<br />

ampułki<br />

11794 SECALE/GALENIT comp.<br />

granulki<br />

31/12/05<br />

21/03/07<br />

30/10/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

11795 Sectral Acebutololum Film-coated tablets 200 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/11/05<br />

11796 Sectral Acebutololum Film-coated tablets 200 mg Rhône-Poulenc Rorer Specia 31/05/04<br />

11797 Sectral Acebutololum Film-coated tablets 400 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/11/05<br />

11798 Sectral Acebutololum Film-coated tablets 400 mg Rhône-Poulenc Rorer Specia 31/05/04


EN<br />

1258 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11799 Secural Nonoxinolum 9 Pessary 75 mg SecFarm — Towarzystwo<br />

Przemysłowo-Handlowe Sp.<br />

z o.o.<br />

11800 Securopen Azlocillinum Powder for solution<br />

for intravascular<br />

injection and infusion<br />

11801 Securopen Azlocillinum Powder for solution<br />

for intravascular<br />

injection and infusion<br />

11802 Securopen Azlocillinum Powder for solution<br />

for intravascular<br />

injection and infusion<br />

11803 Sedacoron Amiodaronum Intravenous injection<br />

(solution)<br />

31/01/06<br />

0.5 g Bayer AG 30/04/04<br />

2 g Bayer AG 30/04/04<br />

5 g Bayer AG 30/04/04<br />

0.15 g/3 ml EBEWE Arzneimittel GmbH 31/12/08<br />

11804 Sedacoron Amiodaronum Tablets 200 mg EBEWE Arzneimittel GmbH 31/12/08<br />

11805 Sedafucon mite Coated tablets Pharma Funcke 31/12/08<br />

11806 Sedalia Syrup Laboratoires BOIRON 27/09/07<br />

11807 Sedalin 35 mg Acepromazyny<br />

maleinian<br />

11808 Sedalin 7 mg Acepromazyny<br />

maleinian<br />

11809 Sedalin gel Acepromazyny<br />

maleinian<br />

Tablet for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Gel for veterinary<br />

use<br />

Vetoquinol S.A. 14/11/05<br />

Vetoquinol S.A. 14/11/05<br />

Vetoquinol S.A. 14/11/05<br />

11810 Sedam 3 Bromazepamum Tablets 3 mg Hexal AG 29/03/06<br />

11811 Sedam 6 Bromazepamum Tablets 6 mg Hexal AG 29/03/06<br />

11812 Sedamel Farmaceutyczne<br />

Przedsie˛biorstwo Prod. —<br />

Anal. — Handl. ‘PROLAB’<br />

s.c., Nakło<br />

31/12/08<br />

11813 Sedatif PC Tablets Laboratoires BOIRON 31/12/07<br />

11814 Sedazin Ksylazyny<br />

chlorowodorek<br />

11815 Sedivet 1 % Romifidyny<br />

chlorowodorek<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Biowet Puławy 06/02/29<br />

Boehringer Ingelheim<br />

Vetmedica GmbH<br />

29/03/07<br />

11816 Sedomix Oral solution Dar Natury P.P.H. 31/12/05<br />

11817 Segan Selegilinum Tablets 5 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

11818 Selamer Omega-3-trójglicerydy Capsules, soft 300 mg Tymofarm —<br />

Przedsie˛biorstwo Rolno-<br />

Przetwórcze<br />

31/12/07<br />

30/10/05<br />

11819 Selax o smaku czekoladowym Sennosides Buccal tablets 25 mg UNIPHARM INC. 31/12/08<br />

11820 Selax o smaku waniliowym Sennosides Buccal tablets 25 mg UNIPHARM INC. 31/12/08<br />

11821 Selcewet Acidum ascorbicum +<br />

Natrii selenas<br />

Powder for veterinary<br />

use<br />

11822 Selecta obroz˙a dla kotów Diazinon Collar for veterinary<br />

use<br />

11823 Selecta obroz˙a dla psów Diazinon Collar for veterinary<br />

use<br />

Pliva Kraków 17/08/04<br />

Francodex 25/04/04<br />

Francodex 25/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1259<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11824 Selecta obroz˙a dla psów<br />

duz˙ych<br />

Diazinon Collar for veterinary<br />

use<br />

Francodex 25/04/04<br />

11825 Selegiline Selegilinum Tablets 5 mg Bioglan 31/12/08<br />

11826 Selegiline Selegilinum Tablets 10 mg Bioglan 31/12/08<br />

11827 Selenium and Zinc Tablets Power Health Products Ltd. 30/08/04<br />

11828 Selenium Bonus Tablets Lifeplan Products Ltd. 30/04/04<br />

11829 Selenium-Homaccord Amp. Heel GmbH 31/12/08<br />

11830 Selenium-Homaccord Drops Heel GmbH 31/12/08<br />

11831 Selenor Selegilinum Tablets 10 mg Norton Healthcare Ltd. 31/12/08<br />

11832 Selenor Selegilinum Tablets 5 mg Norton Healthcare Ltd. 31/12/08<br />

11833 Selerin Selegilinum Tablets 5 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

11834 Selgin Selegilinum Tablets 5 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

31/12/08<br />

11835 Selgres Selegilinum Film-coated tablets 10 mg ICN Polfa Rzeszów S.A. 30/10/05<br />

11836 Selgres Selegilinum Film-coated tablets 5 mg ICN Polfa Rzeszów S.A. 30/10/05<br />

11837 Seliratio Selegilinum Tablets 5 mg Ratiopharm GmbH 24/05/06<br />

11838 Selofen Zaleplonum Capsules 5 mg Adamed Sp. z o.o. 31/12/08<br />

11839 Selofen Zaleplonum Capsules 10 mg Adamed Sp. z o.o. 31/12/08<br />

11840 Selsun 2,5 % Selenii sulfas Shampoo 25 mg/ml Abbott France S.A. 31/08/04<br />

11841 Selsun Blue (do normalnych<br />

włosów)<br />

11842 Selsun Blue (do tłustych<br />

włosów)<br />

Selenii sulfas Shampoo 10 mg/ml Abbott France S.A. 31/01/05<br />

Selenii sulfas Shampoo 10 mg/ml Abbott France S.A. 31/01/05<br />

11843 Senacon Zopiclonum Film-coated tablets 7,5 mg Polfarmex Sp. z o.o. 31/12/08<br />

11844 Senalax Sennae folium extractum<br />

siccum<br />

11845 Senalax K Sennae folium extractum<br />

siccum + Frangulae<br />

cortex extractum siccum<br />

11846 Senefol Sennae folium cum<br />

fructus<br />

Syrup 50 mg/5ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Capsules, soft 25mg + 67mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Tablets 270 mg Labofarm — Innowacyjno-<br />

Wdroz˙eniowe Laboratorium<br />

Farmaceutyczne<br />

11847 Senes Herbal tea Elanda s.c. — Zakład<br />

Produkcji S´ rodków<br />

Farmaceutycznych<br />

11848 Senesfit fix Hibisci flos + Sennae<br />

folium<br />

11849 Seniflor Film-coated tablets Preparat<br />

złoz˙ony<br />

11850 Senlek Valerianae radix,<br />

Lavandulae flos<br />

23/11/05<br />

23/11/05<br />

31/01/05<br />

5/07/05<br />

Herbal tea Herbapol — Białostok S.A. 31/12/08<br />

US Pharmacia 31/12/08<br />

Tablets Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

31/12/08<br />

11851 Sennfolax Sennae folium Tablets 280 mg ‘HERBAPOL — ŁÓDZ´ ’ S.A. 31/12/08


EN<br />

1260 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11852 Senovit Preparat ziołowy Capsules, soft Bional International BV 24/08/05<br />

11853 Sensiblex Danaweryna Solution for veterinary<br />

use<br />

Veyx Pharma 31/12/08<br />

11854 Sensit Fendilinum Film-coated tablets 50 mg Chinoin Pharmaceutical and<br />

Chemical Works Co. Ltd.<br />

30/06/04<br />

11855 Sepatrem 10 Selegilinum Tablets 10 mg Leciva a.s. 31/12/08<br />

11856 Sepatrem 5 Selegilinum Tablets 5 mg Leciva a.s. 31/12/08<br />

11857 Sepia compose krople Dolisos Laboratoires 31/12/08<br />

11858 Sepropol 1 % Propolis extractum Ointment Polska Fundacja Apiterapii 31/12/08<br />

11859 Sepropol 3 % Propolis extractum Ointment Polska Fundacja Apiterapii 31/12/08<br />

11860 Septalan Allantoinum +<br />

Tripaflavinum<br />

11861 Septanest z adrenalina˛<br />

1:100 000<br />

11862 Septanest z adrenalina˛<br />

1:200 000<br />

Articainum +<br />

Epinephrinum<br />

Articainum +<br />

Epinephrinum<br />

Ointment (20mg +<br />

1,25mg)/g<br />

Solution for injection (40mg +<br />

0,01mg)/ml<br />

Solution for injection (40mg +<br />

0,05mg)/ml<br />

Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

31/01/06<br />

Septodont 2/09/06<br />

Septodont 2/09/06<br />

11863 Septin Herbal tea Herbapol — Lublin S.A. 31/12/08<br />

11864 Septofervex Chlorhexidinum Buccal tablet 2 mg Pharmavit Kft. 30/09/07<br />

11865 Septoflos Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

31/03/05<br />

11866 Septolete Lozenge Krka d.d., Novo mesto 31/07/04<br />

11867 Septolete D Lozenge Krka d.d., Novo mesto 31/01/05<br />

11868 Septolete Plus Benzocainum +<br />

Cetylpirydinum<br />

chloridum<br />

Lozenge 5 mg + 1 mg KRKA d.d., Novo mesto 31/12/08<br />

11869 Septopal minikette Gentamicinum łańcuch koralików Merck KGaA 31/07/04<br />

11870 Septosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

11871 Septosan fix Mieszanka ziołowa Instant herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

11872 Septovit Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

11873 Septovit Instant herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

11874 Septrin Sulfamethoxazolum +<br />

Trimethoprimum<br />

11876 Septrin Sulfamethoxazolum +<br />

Trimethoprimum<br />

11875 Septrin Sulfamethoxazolum +<br />

Trimethoprimum<br />

11877 Sera Baktopur Glikol butylowy,<br />

Akriflawina, Błe˛kit<br />

metylenowy<br />

11878 Sera Baktopur Direct Nifurpirinol, Sodu<br />

chlorek<br />

Concentrate for<br />

solution for<br />

intravenous infusion<br />

0.96 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Oral suspension 240 mg/5 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Tablets 480 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Liquid for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

30/10/05<br />

31/03/07<br />

30/06/04<br />

14/08/06<br />

30/07/05<br />

Sera GmbH 24/08/06<br />

Sera GmbH 24/08/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1261<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11879 Sera Costapur Potasu jodek,<br />

Szczawian zieleni<br />

malachitowej<br />

11880 Sera Ectopur Sodu nadboran, Sodu<br />

boran, Sodu chlorek<br />

11881 Sera Mycopur Akriflawina,<br />

Miedzio(II)siarczan,<br />

Miedzio(II)chlorek<br />

11882 Sera Oodinopur A Miedzio(II)siarczan,<br />

Miedzio(II)chlorek<br />

Liquid for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Sera GmbH 24/08/06<br />

Sera GmbH 24/08/06<br />

Sera GmbH 24/08/06<br />

Sera GmbH 24/08/06<br />

11883 Seractil Dexibuprofenum Film-coated tablets 200 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

11884 Seractil Dexibuprofenum Film-coated tablets 300 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

11885 Seractil Dexibuprofenum Film-coated tablets 400 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

12/10/05<br />

12/10/05<br />

12/10/05<br />

11886 Serdolect Sertindolum Tablets 4mg H. Lundbeck A/S 31/12/08<br />

11887 Serdolect Sertindolum Tablets 12mg H. Lundbeck A/S 31/12/08<br />

11888 Serdolect Sertindolum Tablets 16 mg H. Lundbeck A/S 31/12/08<br />

11889 Serdolect Sertindolum Tablets 20 mg H. Lundbeck A/S 31/12/08<br />

11890 Seretide 125 Fluticasonum +<br />

Salmeterolum<br />

11891 Seretide 250 Fluticasonum +<br />

Salmeterolum<br />

11892 Seretide 50 Fluticasonum +<br />

Salmeterolum<br />

11893 Seretide Dysk 100 Fluticasonum +<br />

Salmeterolum<br />

11894 Seretide Dysk 250 Fluticasonum +<br />

Salmeterolum<br />

11895 Seretide Dysk 500 Fluticasonum +<br />

Salmeterolum<br />

Pressurised inhalation,<br />

suspension<br />

Pressurised inhalation,<br />

suspension<br />

Pressurised inhalation,<br />

suspension<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Inhalation powder Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Inhalation powder Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Inhalation powder Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

25/10/06<br />

25/10/06<br />

25/10/06<br />

24/08/05<br />

24/08/05<br />

24/08/05<br />

11896 Sereto 20 Paroxetinum Film-coated tablets 20 mg A/S Gea Farmaceutisk Fabrik 31/12/08<br />

11897 Sereto 40 Paroxetinum Film-coated tablets 40 mg A/S Gea Farmaceutisk Fabrik 31/12/08<br />

11898 Serevent Salmeterolum Pressurised inhalation,<br />

suspension<br />

25 mcg/dawke˛<br />

inhalacyjna˛<br />

11899 Serevent Dysk Salmeterolum Inhalation powder 50 mcg/dawke˛<br />

inhalacyjna˛<br />

11900 Serevent Rotadisk Salmeterolum Inhalation powder 0.05 mg/dawke˛<br />

inhalacyjna˛<br />

11901 Serevent Rotadisk Salmeterolum Inhalation powder 50 mcg/dawke˛<br />

inhalacyjna˛<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/12/04<br />

31/10/04<br />

30/01/05<br />

Glaxo Wellcome S.A. 30/01/05<br />

11902 Serlift Sertralinum Tablets 50 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

11903 Serlift Sertralinum Tablets 100 mg Ranbaxy Laboratoires Ltd. 31/12/08


EN<br />

1262 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11904 Sermion Nicergolinum Coated tablets 10 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

11906 Sermion Nicergolinum Film-coated tablets 30 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

11905 Sermion Nicergolinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

11907 Serodin Gonadotropinum Lyophilisate + solvent for veterinary<br />

use<br />

11908 Serogonadotropin Hormon<br />

gonadotropowy PMSG<br />

Lyophilisate + solvent for veterinary<br />

use<br />

4 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

30/06/04<br />

30/06/04<br />

30/06/04<br />

Fort Dodge 30/01/06<br />

Drwalewskie Zakłady<br />

Przemysłu Biowet.<br />

24/05/04<br />

11909 Seromycin Cycloserinum Capsules 250 mg Eli Lilly and Company Ltd 29/06/05<br />

11910 Seronil Fluoxetinum Capsules 20 mg Orion Corporation 1/09/05<br />

11911 Seronil Fluoxetinum Film-coated tablets 10 mg Orion Corporation 1/09/05<br />

11912 Seroquel Quetiapinum Film-coated tablets 100 mg AstraZeneca UK Ltd. 31/08/04<br />

11913 Seroquel Quetiapinum Film-coated tablets 200 mg AstraZeneca UK Ltd. 31/08/04<br />

11914 Seroquel Quetiapinum Film-coated tablets 25 mg AstraZeneca UK Ltd. 31/08/04<br />

11915 Seroxat Paroxetinum Film-coated tablets 20 mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

11916 Seroxat Paroxetinum Film-coated tablets 30 mg SmithKline Beecham<br />

Pharmaceuticals<br />

31/12/05<br />

31/12/05<br />

11917 Sertralex Sertralinum Film-coated tablets 50 mg Expharm Inc. 31/12/08<br />

11918 SERTRALINE 100 mg Sertralinum Film-coated tablets 100 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

11919 SERTRALINE 50 mg Sertralinum Film-coated tablets 50 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/08<br />

11920 Sertrif Sertalinum Film-coated tablets 50 mg Instytut Farmaceutyczny 31/12/08<br />

11921 Sertrif Sertalinum Film-coated tablets 100 mg Instytut Farmaceutyczny 31/12/08<br />

11924 Serviclor Cefaclorum Capsules 250 mg Biochemie GmbH — Kundl 21/06/06<br />

11925 Serviclor Cefaclorum Capsules 500 mg Biochemie GmbH — Kundl 21/06/06<br />

11922 Serviclor Cefaclorum Granules for oral<br />

solution<br />

11923 Serviclor Cefaclorum Granules for oral<br />

solution<br />

125 mg/5ml Biochemie GmbH — Kundl 21/06/06<br />

250 mg/5ml Biochemie GmbH — Kundl 21/06/06<br />

11926 Serviflox Ciprofloxacinum Film-coated tablets 250 mg Biochemie GmbH 31/12/08<br />

11927 Serviflox Ciprofloxacinum Film-coated tablets 500 mg Biochemie GmbH 31/12/08<br />

11928 Serzone Nefazodonum Tablets 100 mg Bristol-Myers Squibb S.p.A. 31/05/05<br />

11929 Serzone Nefazodonum Tablets 200 mg Bristol-Myers Squibb S.p.A. 31/05/05<br />

11930 Serzone Nefazodonum Tablets 300 mg Bristol-Myers Squibb S.p.A. 31/05/05<br />

11931 Serzone Nefazodonum Tablets 50 mg Bristol-Myers Squibb S.p.A. 31/05/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1263<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11932 Set Vac Szczepionka dla kur<br />

przeciwko zakaz˙eniom<br />

salmonella enteritidis I<br />

salmonella<br />

typhimurium<br />

Emulsion for veterinary<br />

use<br />

Fatro 31/12/08<br />

11933 Setegis Terazosinum Tablets 1 mg Egis Pharmaceuticals Ltd. 5/07/06<br />

11934 Setegis Terazosinum Tablets 10 mg Egis Pharmaceuticals Ltd. 5/07/06<br />

11935 Setegis Terazosinum Tablets 2 mg Egis Pharmaceuticals Ltd. 5/07/06<br />

11936 Setegis Terazosinum Tablets 5 mg Egis Pharmaceuticals Ltd. 5/07/06<br />

11937 Setraline Terazosinum Film-coated tablets 50 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

11938 Setron 4 Ondansetronum Film-coated tablets 4 mg Slovakofarma a.s. 31/12/08<br />

11939 Setron 8 Ondansetronum Film-coated tablets 8 mg Slovakofarma a.s. 31/12/08<br />

11940 SETRONON 4 mg Ondansetronum Film-coated tablets 4 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

11941 SETRONON 8 mg Ondansetronum Film-coated tablets 8 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/08<br />

11942 Sevitren Capsules, hard Krka d.d., Novo mesto 24/08/05<br />

11943 Sevorane Sevofluranum Pressurised inhalation<br />

solution for general<br />

aneasthesia<br />

250ml Abbott Laboratories Ltd. 31/12/08<br />

11944 Sevredol Morphinum Film-coated tablets 10 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11945 Sevredol Morphinum Film-coated tablets 20 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11946 Shen Chinese Garlic Tablets Allii sativi bulbus pulv. Coated tablets G.R. Lane Health Products<br />

Ltd.<br />

11947 Shotapen Benzathini<br />

benzaylpenicillinum +<br />

Benzylpenicillinum<br />

procainicum +<br />

Dihydrostreptomycinum<br />

Suspension for veterinary<br />

use<br />

15/03/06<br />

15/03/06<br />

30/04/04<br />

Virbac S.A. 19/06/05<br />

11948 Siarka stra˛cona BUFA b.v. Pharmaceutical<br />

Products<br />

11949 Siarka stra˛cona Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

11950 Siarka stra˛cona Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

11951 Siarka stra˛cona Lefarm, Bydgoszcz 30/11/05<br />

11952 Siarka stra˛cona Pampa, Piaseczno 30/11/05<br />

11953 Siarka stra˛cona Pharma Cosmetic, Kraków 30/11/05<br />

11954 Siarka stra˛cona Pharma Zentrale 30/11/05<br />

11955 Siarka stra˛cona PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

30/11/05<br />

11956 Siarka stra˛cona Siarkopol, Tarnobrzeg 30/11/05<br />

11957 Siarka sublimowana Pharma Cosmetic, Kraków 31/12/08


EN<br />

1264 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11958 Siarka sublimowana Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

11959 Siarka sublimowana PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

31/12/08<br />

11960 Siarka sublimowana Siarkopol, Tarnobrzeg 31/12/08<br />

11961 Siberian Ginseng Tablets 600 mg Lifeplan Products Ltd. 15/05/06<br />

11962 Sibutramine Hydrochloride Sibutraminum Capsule 10 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

11963 Sibutramine Hydrochloride Sibutraminum Gelatine capsule Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

11964 Siccovet Preparat złoz˙ony Intramammary<br />

ointment<br />

for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

Werfft-Chemie 14/06/04<br />

11965 Signopam Temazepamum Tablets 10 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11966 Sildenafil Sildenafilum Tablets PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

11967 Silenil Hyperyci herba extractum<br />

siccum<br />

11968 SILICEA COLLOIDALIS comp.,<br />

z˙el<br />

31/12/05<br />

31/12/08<br />

Film-coated tablets 300 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

WALA-Heilmittel GmbH 19/03/05<br />

11969 SILICEA comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

11970 SILICEA comp. czopki dla<br />

dzieci 1g<br />

11971 SILICEA comp. czopki dla<br />

dzieci 2g<br />

WALA-Heilmittel GmbH 19/03/05<br />

WALA-Heilmittel GmbH 19/03/05<br />

11972 SILICEA comp. gran. WALA-Heilmittel GmbH 19/03/05<br />

11973 Silimax Silymarin Capsules, hard 70 mg Filofarm Farmaceutyczna<br />

Spółdzienia Pracy<br />

11974 Silimax Silymarin Film-coated tablets 70 mg Filofarm Farmaceutyczna<br />

Spółdzienia Pracy<br />

11975 Silitympakon Dimetylopolisiloksan,<br />

Emulgator P-3 Extra<br />

Suspension for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

11976 Silkis Calcitriolum Ointment 3 mcg/g Laboratoires Galderma S.A.<br />

Tour Europlaza<br />

11978 Silol 350 F Dimeticonum Coutanous liquid Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp.<br />

z o.o.<br />

11977 Silol 350 F Dimeticonum Cutaneous spray 366.7 mg/ml Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

11979 Silol 1000 F Dimeticonum Coutanous liquid Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp.<br />

z o.o.<br />

11980 Silvercol Argentum colloidale Coutanous liquid Zakład Produkcji Sprze˛tu<br />

Medycznego RAVIMED Sp.<br />

z o.o.<br />

9/08/06<br />

9/08/06<br />

29/04/04<br />

15/11/06<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

31/12/08<br />

11981 Simaroline Vaselinum album Cream Rochler 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1265<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

11982 Simdax Levosimendanum Concentrate for<br />

solution for infusion<br />

2,5 mg/ml Abbott Laboratories Poland<br />

Sp. z o.o.<br />

11983 Simepar ® Preparat złoz˙ony Capsules, hard Mepha Pharm Ltd.,<br />

Szwajcaria<br />

31/12/08<br />

31/12/08<br />

11984 Simet Simeticonum Chewable tablets 80 mg Kato LABS Sp. z o.o. 30/06/05<br />

11985 Simet-Al Aluminii hydroxidum +<br />

Dimeticonum +<br />

Magnesii hydroxidum<br />

Buccal tablet Kato LABS Sp. z o.o. 30/11/05<br />

11986 Simetikon Simeticonum Capsules, soft 80 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/08<br />

11987 Simgal Simvastatinum Film-coated tablets 10 mg Ivax Pharma Sp. z o.o. 23/11/05<br />

11988 Simgal Simvastatinum Film-coated tablets 20 mg Ivax Pharma Sp. z o.o. 23/11/05<br />

11989 Simgal Simvastatinum Film-coated tablets 40 mg Ivax Pharma Sp. z o.o. 23/11/05<br />

11990 Similac 1 Preparat odz˙ywczy Powder Abbott Laboratories S.A. 24/08/05<br />

11991 Similac 2 Preparat odz˙ywczy Powder Abbott Laboratories S.A. 24/08/05<br />

11992 Similac HH Preparat odz˙ywczy Powder Abbott Laboratories S.A. 26/04/06<br />

11993 Similac LF Preparat odz˙ywczy Powder Abbott Laboratories S.A. 15/11/06<br />

11994 Simpanorm Karazololu<br />

chlorowodorek<br />

Solution for veterinary<br />

use<br />

FATRO S.p.A. 15/02/06<br />

11995 Simratio 10 Simvastatinum Film-coated tablets 10 mg ratiopharm GmbH 31/12/08<br />

11996 Simratio 20 Simvastatinum Film-coated tablets 20 mg ratiopharm GmbH 31/12/08<br />

11997 Simratio 40 Simvastatinum Film-coated tablets 40 mg ratiopharm GmbH 31/12/08<br />

11998 Simredin 10 Simvastatinum Film-coated tablets 10 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

11999 Simredin 20 Simvastatinum Film-coated tablets 20 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12000 Simredin 40 Simvastatinum Film-coated tablets 40 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12001 Simulect Basiliximabum Powder and solvent<br />

for solution for<br />

intravenous injection<br />

and intravenous<br />

infusion<br />

30/04/05<br />

30/04/05<br />

30/04/05<br />

20 mg Novartis Pharma AG 31/08/04<br />

12002 Simvacard 10 Simvastatinum Film-coated tablets 10 mg Lečiva a.s. 25/04/07<br />

12003 Simvacard 20 Simvastatinum Film-coated tablets 20 mg Lečiva a.s. 25/04/07<br />

12004 Simvacard 40 Simvastatinum Film-coated tablets 40 mg Lečiva a.s. 25/04/07<br />

12005 Simvachol Simvastatinum Film-coated tablets 10 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

12006 Simvachol Simvastatinum Film-coated tablets 20 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

12007 Simvachol Simvastatinum Film-coated tablets 40 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

16/05/07<br />

16/05/07<br />

16/05/07<br />

12008 Simvacor Simvastatinum Film-coated tablets 10 mg Polfarmex Sp. z o.o. 31/12/08


EN<br />

1266 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12009 Simvacor Simvastatinum Film-coated tablets 20 mg Polfarmex Sp. z o.o. 31/12/08<br />

12010 SIMVAGAMMA 10 mg Simvastatinum Film-coated tablets 10 mg A.P.C. Instytut Sp. z o.o. 31/12/08<br />

12011 SIMVAGAMMA 20 mg Simvastatinum Film-coated tablets 20 mg A.P.C. Instytut Sp. z o.o. 31/12/08<br />

12012 SIMVAGAMMA 40 mg Simvastatinum Film-coated tablets 40 mg A.P.C. Instytut Sp. z o.o. 31/12/08<br />

12013 SIMVAGAMMA 5 mg Simvastatinum Film-coated tablets 5 mg A.P.C. Instytut Sp. z o.o. 31/12/08<br />

12014 Simvasterol Simvastatinum Film-coated tablets 10 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12015 Simvasterol Simvastatinum Film-coated tablets 20 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12016 Simvasterol Simvastatinum Film-coated tablets 40 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12017 Simvasterol Simvastatinum Film-coated tablets 5 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

14/02/07<br />

14/02/07<br />

14/02/07<br />

14/02/07<br />

12018 Simvax 10 Simvastatinum Film-coated tablets 10 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

12019 Simvax 20 Simvastatinum Film-coated tablets 20 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

12020 Simvax 40 Simvastatinum Film-coated tablets 40 mg HEXAL Polska Sp. z o.o. 31/12/08<br />

12021 Simvor Simvastatinum Film-coated tablets 10 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

12022 Simvor Simvastatinum Film-coated tablets 20 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

12023 Simvor Simvastatinum Film-coated tablets 40 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

12024 Simwastatyna Simvastatinum Film-coated tablets 20 mg ; 40 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

12025 Sindaxel Paclitaxelum Concentrate for<br />

solution for<br />

intravenous infusion<br />

12026 Sindaxel Paclitaxelum Concentrate for<br />

solution for<br />

intravenous infusion<br />

12027 Sindaxel Paclitaxelum Concentrate for<br />

solution for<br />

intravenous infusion<br />

31/12/08<br />

30 mg/5 ml s.c. Sindan SRL 31/12/08<br />

100 mg/<br />

16,67 ml<br />

260 mg/<br />

43,33 ml<br />

s.c. Sindan SRL 31/12/08<br />

s.c. Sindan SRL 31/12/08<br />

12028 Sindronat Dinatrii clodronas Capsules, hard 400 mg S.C. Sindan S.R.L 4/07/07<br />

12029 Sinecod Butamiratum Oral drops 5 mg/ml Novartis Consumer Health<br />

S.A.<br />

12030 Sinecod Butamiratum Syrup 1.5 mg/ml Novartis Consumer Health<br />

S.A.<br />

12031 Sinemet Carbidopum +<br />

Levodopum<br />

12032 Sinemet CR 100/25 Carbidopum +<br />

Levodopum<br />

12033 Sinemet CR 200/ 50 Carbidopum +<br />

Levodopum<br />

Tablets 25mg +<br />

250mg<br />

Modified release<br />

tablets<br />

Modified release<br />

tablets<br />

25mg +<br />

100mg<br />

50mg +<br />

200mg<br />

Merck Sharp & Dohme Idea<br />

Inc.<br />

30/06/07<br />

30/06/07<br />

31/07/04<br />

Merck Sharp & Dohme B.V. 31/12/08<br />

Merck Sharp & Dohme Idea<br />

Inc.<br />

30/03/04<br />

12034 Sinequan Doxepinum Capsules 10 mg Pfizer S.A. — Bruksela 18/10/06<br />

12035 Sinequan Doxepinum Capsules 25 mg Pfizer S.A. — Bruksela 18/10/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1267<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12036 Sinex Oxymetazolini<br />

hydrochloridum<br />

Nasal drops 0.05 % Wick Pharma 31/12/08<br />

12037 Singulair 10 Montelukastum Film-coated tablets 10 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

12038 Singulair 4 Montelukastum Chewable tablets 4 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

12039 Singulair 5 Montelukastum Chewable tablets 5 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

12040 Sinkast Motelukastum Tablets 4mg, 5 mg i<br />

10 mg<br />

12041 Sintopozid Etoposidum Concentrate for<br />

solution for<br />

intravenous infusion<br />

Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

31/12/08<br />

26/04/06<br />

31/12/08<br />

31/12/08<br />

100 mg/ 5 ml S.C. Sindan S.R.L 4/07/07<br />

12042 Sintrom Acenocoumarolum Tablets 4 mg Novartis Pharma AG 31/07/04<br />

12043 Sinuc Hederae helicis folium<br />

extractum siccum<br />

12044 Sinuc Hederae helicis folium<br />

extractum siccum<br />

Syrup 45 mg/ 5 ml Biocur Arzneimittel GmbH 31/12/08<br />

Drops Biocur Arzneimittel GmbH 31/12/08<br />

12045 Sinupas krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

30/11/05<br />

12046 Sinupret Coated tablets Bionorica AG 31/12/08<br />

12047 Sinupret Drops Bionorica AG 31/12/08<br />

12048 Sinusitis comp. krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

30/11/05<br />

12049 Sinuspax Tablets Lehning Laboratoires 31/12/08<br />

12050 Siofor 500 Metformini<br />

hydrochloridum<br />

12051 Siofor 850 Metformini<br />

hydrochloridum<br />

Film-coated tablets 500 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

Film-coated tablets 850 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

12052 Siraliden Nitrofurantoinum Oral suspension 50 mg/5 ml Medana Pharma Terpol<br />

Group S.A.<br />

31/12/04<br />

31/12/04<br />

30/09/05<br />

12053 Sirdalud Tizanidinum Tablets 4 mg Novartis Pharma AG 4/06/06<br />

12054 Sirdalud MR Tizanidinum Modified release<br />

capsules, hard<br />

12055 Sirupus Acidi eaminocapronici<br />

6 mg Novartis Pharma AG 4/06/06<br />

Acidum aminocaproicum Syrup 1 g/5ml Ziołolek — Przedsie˛biorstwo<br />

Farmaceutyczne Sp. z o.o.<br />

12056 Sirupus Althaeae Syrup 131 mg/5ml Microfarm s.c.<br />

Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

12057 Sirupus Kalii guajacolosulfonici Guaiacolsulfonatum Syrup 60 mg/g VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

12058 Sirupus Pini compositus Syrup Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

12059 Sirupus Plantaginis Plantaginis extractum<br />

fluidum<br />

Syrup 647 mg/5ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

12060 Sirupus Tussipini Preparat ziołowy Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

30/10/05<br />

31/01/06<br />

31/12/05<br />

30/10/05<br />

31/03/06<br />

30/10/05


EN<br />

1268 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12061 Sirupus Tussipini D Preparat ziołowy Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

12062 Sirupus Verbasci Verbasci extractum<br />

fluidum<br />

Syrup 952 mg/5ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

12063 Sirupus Verbasci Syrup 253 mg/5ml Rolnicza Spółdzielnia<br />

Produkcyjno-Usługowa<br />

31/12/08<br />

31/03/07<br />

30/10/05<br />

12064 Sitosterin Al. Sitosteronum beta Capsules 65 mg Aliud Pharma GmbH 30/06/04<br />

12065 Sitosteronin Betasitosterolum Capsules 50 mg Kenay A.G.", Cze˛stochowa 31/12/08<br />

12066 Skelid Acidum tiludronicum Tablets 200 mg Sanofi Winthrop-Gentilly 31/12/08<br />

12067 Skenan Morphinum Prolonged release<br />

capsules<br />

12068 Skenan Morphinum Prolonged release<br />

capsules<br />

12069 Skenan Morphinum Prolonged release<br />

capsules<br />

12070 Skenan Morphinum Prolonged release<br />

capsules<br />

10 mg UPSA Laboratoires Agen 31/12/08<br />

100 mg UPSA Laboratoires Agen 31/12/08<br />

30 mg UPSA Laboratoires Agen 31/12/08<br />

60 mg UPSA Laboratoires Agen 31/12/08<br />

12071 Skinoren Acidum azelaicum Cream 200 mg/g Schering AG 31/01/05<br />

12072 Skinoren Acidum azelaicum Gel 150 mg/g Schering AG 15/11/06<br />

12073 Skinsept Oral Mouth wash solution Henkel Hygiene GmbH 31/12/08<br />

12074 Sklerosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

12075 Sklero-var Varia, Katowice 31/12/08<br />

12076 Sklerovit Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

12077 Sklerovit fix Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

30/10/05<br />

30/09/07<br />

12078 Skorodit comp. Amp. WALA-Heilmittel GmbH 24/05/07<br />

12079 Skorodit comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

12080 Skrobia pszeniczna BUFA b.v. Pharmaceutical<br />

Products<br />

24/01/05<br />

12081 Skrobia pszeniczna Caesar & Loretz GmbH Caelo 24/01/05<br />

12082 Skrobia pszeniczna Pharma Zentrale 24/01/05<br />

12083 Skrobia pszeniczna PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

24/01/05<br />

12084 Skrobia ziemniaczana IŁAWA, Iława 15/01/07<br />

12085 Skrobia ziemniaczana Pharma Zentrale 15/01/07<br />

12086 Skrobia ziemniaczana PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

12087 Sleepia Diphenhydrominum Capsules 50 mg Heinrich Mack Nachf. GmbH<br />

& Co. KG<br />

12088 Slimossa Instant herbal tea Jiangxi Ning Hong Tea Group<br />

Co. Ltd<br />

15/01/07<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1269<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12089 Slim-Var Instant herbal tea Varia — Zakłady Zielarsko-<br />

Farmaceutyczne Sp. z o.o.<br />

31/01/06<br />

12090 Slim-var Varia, Katowice 31/01/06<br />

12091 Slovadol Tramadolum Solution for injection 50 mg/ml Slovakofarma a.s. 22/02/06<br />

12092 SLOVADOL Retard Tramadolum Prolonged release<br />

tablets<br />

12093 Slovadol, Tramadol 50-<br />

Slovakofarma<br />

12094 Slovadol, Tramadol-<br />

Slovakofarma<br />

12095 SLOVALGIN 100 Retard Morphinum Modified release<br />

tablets<br />

100 mg Slovakofarma a.s. 31/12/08<br />

Tramadolum Capsules 50 mg Slovakofarma a.s. 27/04/05<br />

Tramadolum Oral drops, solution 100 mg/1 ml Slovakofarma a.s. Hlodovec 12/10/05<br />

12096 Slovalgin 30 retard Morphinum Film-coated, prologed<br />

release tablets<br />

12097 SLOVALGIN 60 Retard Morphinum Modified release<br />

tablets<br />

12098 Slovit C 250 Acidum ascorbicum<br />

(vit C)<br />

12099 Slovit C 250 Acidum ascorbicum<br />

(vit C)<br />

12100 Slovit C 250 Acidum ascorbicum<br />

(vit C)<br />

12101 Slovit C 500 Acidum ascorbicum<br />

(vit C)<br />

12102 Slovit C 500 Acidum ascorbicum<br />

(vit C)<br />

12103 Slovit C 500 Acidum ascorbicum<br />

(vit C)<br />

12104 Slow-Mag Magnesii chloridum Film-coated,<br />

gastro-resistant tablets<br />

12105 Slow-Mag B6 Magnesii chloridum +<br />

Pyridoxinum (vit B6)<br />

Slovakofarma a.s. 31/12/08<br />

30 mg Slovakofarma a.s. 31/05/05<br />

Slovakofarma a.s. 31/12/08<br />

Effervescent tablets 250 mg Slovakofarma a.s. 31/12/08<br />

Effervescent tablets 250 mg Slovakofarma a.s. 31/12/08<br />

Effervescent tablets 250 mg Slovakofarma a.s. 31/12/08<br />

Effervescent tablets 500 mg Slovakofarma a.s. 30/06/04<br />

Effervescent tablets 500 mg Slovakofarma a.s. 30/06/04<br />

Effervescent tablets 500 mg Slovakofarma a.s. 30/06/04<br />

Film-coated,<br />

gastro-resistant tablets<br />

64 mg Mg ++ Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

12106 Sma Human Milk Fortifier Odz˙ywka Wyeth — Lederle Pharma<br />

GmbH<br />

31/12/05<br />

31/05/06<br />

31/12/08<br />

12107 Smalec Pharma Cosmetic, Kraków 31/12/08<br />

12108 Smalec Pharma Zentrale 31/12/08<br />

12109 Smalec PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

12110 Smecta Diomektyt Powder for oral<br />

suspension<br />

12111 Sodiofolin Acidum folinicum Solution for<br />

intravenous injection<br />

and infusion<br />

12112 Sodium Iodide (I 131) Capsule D Preparat<br />

radiofarmaceutyczny<br />

31/12/08<br />

Beaufour Ipsen Pharma 30/04/04<br />

50 mg/ml medac Gesellschaft medac<br />

Gesellschaft für klinische<br />

Spezialpräparate mbH<br />

31/12/08<br />

Mallinckrodt Medical B.V. 31/12/08


EN<br />

1270 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12113 Sodium Iodide (I 131) Capsule T Preparat<br />

radiofarmaceutyczny<br />

Mallinckrodt Medical B.V. 31/12/08<br />

12114 Sodowy czteroboran Pharma Cosmetic, Kraków 31/12/08<br />

12115 Sodowy dwuwodorofosforan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

12116 Sodowy we˛glan Przedsie˛biorstwo Chmiczne<br />

Odczynniki Sp. z o.o., Lublin<br />

30/09/05<br />

10/02/07<br />

12117 Sodu azotyn Pharma Zentrale 14/02/05<br />

12118 Sodu benzoesan A.C.E.F., Włochy 31/12/08<br />

12119 Sodu benzoesan BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08<br />

12120 Sodu benzoesan Farm-Impex s.j., Gliwice 31/12/08<br />

12121 Sodu benzoesan Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

12122 Sodu benzoesan Margo Corporation,<br />

Warszawa<br />

31/12/08<br />

31/12/08<br />

12123 Sodu benzoesan Pharma Cosmetic, Kraków 31/12/08<br />

12124 Sodu benzoesan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

12125 Sodu benzoesan PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

31/12/08<br />

12126 Sodu bromek Hasco-Lek, Wroclaw 31/12/07<br />

12127 Sodu bromek Pharma Zentrale 31/12/07<br />

12128 Sodu bromek Przedsie˛biorstwo Chmiczne<br />

Odczynniki Sp. z o.o., Lublin<br />

31/12/07<br />

12129 Sodu chlorek Biochem, Warszawa 30/11/05<br />

12130 Sodu chlorek Pharma Cosmetic, Kraków 30/11/05<br />

12131 Sodu chlorek Pharma Zentrale 30/11/05<br />

12132 Sodu chlorek Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

12133 Sodu chlorek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

30/11/05<br />

30/11/05<br />

12134 Sodu chlorek Produkt-Sol, Wieliczka 30/11/05<br />

12135 Sodu cytrynian Pharma Cosmetic, Kraków 31/12/08<br />

12136 Sodu cytrynian Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

12137 Sodu dwowodorofosforan Natrii<br />

dihydrophosphas<br />

12138 Sodu dwuwodorofosforan Natrii<br />

dihydrophosphas<br />

31/12/08<br />

Pharma Cosmetic, Kraków 30/09/05<br />

Pharma Zentrale 30/06/06<br />

12139 Sodu fluorek Caesar & Loretz GmbH Caelo 31/12/08<br />

12140 Sodu jodek Margo Corporation,<br />

Warszawa<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1271<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12141 Sodu jodek Pharma Cosmetic, Kraków 31/12/08<br />

12142 Sodu jodek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

12143 Sodu octan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

12144 Sodu octan Przedsie˛biorstwo Chmiczne<br />

Odczynniki Sp. z o.o., Lublin<br />

31/12/08<br />

30/09/05<br />

30/09/05<br />

12145 Sodu salicylan A.C.E.F., Włochy 31/12/08<br />

12146 Sodu salicylan BUFA b.v. Pharmaceutical<br />

Products<br />

31/12/08<br />

12147 Sodu salicylan Pharma Cosmetic, Kraków 31/12/08<br />

12148 Sodu salicylan Scholz, Sowin 31/12/08<br />

12149 Sodu salicylan Zakłady Farmaceutyczne<br />

Polpharma SA, Starogard<br />

Gdański<br />

12150 Sodu siarczan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

31/12/08<br />

30/09/05<br />

12151 Sodu siarczan bezwodny Pharma Cosmetic, Kraków 30/09/05<br />

12152 Sodu siarczan bezwodny Pharma Zentrale 30/09/05<br />

12153 Sodu tetraboran Farm-Impex s.j., Gliwice 19/11/07<br />

12154 Sodu tetraboran Pharma Zentrale 19/11/07<br />

12155 Sodu tetraboran Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

12156 Sodu tetraboran PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

12157 Sodu tetraboran Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

12158 Sodu tiosiarczan BUFA b.v. Pharmaceutical<br />

Products<br />

19/11/07<br />

19/11/07<br />

19/11/07<br />

31/03/06<br />

12159 Sodu tiosiarczan Cefarm Wrocław 31/03/06<br />

12160 Sodu tiosiarczan Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

12161 Sodu tiosiarczan Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

31/03/06<br />

31/03/06<br />

12162 Sodu tiosiarczan Pharma Cosmetic, Kraków 31/03/06<br />

12163 Sodu tiosiarczan Pharma Zentrale 31/03/06<br />

12164 Sodu tiosiarczan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

12165 Sodu tiosiarczan PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/03/06<br />

31/03/06<br />

12166 Sodu wodorofosforan Natrii hydrophosphas Pharma Cosmetic, Kraków 30/09/05<br />

12167 Sodu wodorofosforan Natrii hydrophosphas Pharma Zentrale 30/09/05<br />

12168 Sodu wodorowe˛glan A.C.E.F., Włochy 31/12/08


EN<br />

1272 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12169 Sodu wodorowe˛glan Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/08<br />

12170 Sodu wodorowe˛glan Biochem, Warszawa 31/12/08<br />

12171 Sodu wodorowe˛glan Farm-Impex s.j., Gliwice 31/12/08<br />

12172 Sodu wodorowe˛glan Hasco-Lek, Wrocław 31/12/08<br />

12173 Sodu wodorowe˛glan Karima, Łódz´ 31/12/08<br />

12174 Sodu wodorowe˛glan Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

31/12/08<br />

12175 Sodu wodorowe˛glan Maga-Herba s.c., Legionowo 31/12/08<br />

12176 Sodu wodorowe˛glan Pharma Cosmetic, Kraków 31/12/08<br />

12177 Sodu wodorowe˛glan Pharma Zentrale 31/12/08<br />

12178 Sodu wodorowe˛glan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

12179 Sodu wodorowe˛glan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

31/12/08<br />

31/12/08<br />

12180 Sodu wodorowe˛glan PPF GEMI, Karczew 31/12/08<br />

12181 Sodu wodorowe˛glan PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

12182 Sodu wodorowe˛glan wkłady:<br />

Bio Carb B; Bio Carb G<br />

31/12/08<br />

Konsan Hightech Medical 24/08/05<br />

12183 Soft Corn Acidum salicylicum Patch 125 mg/g SSL International plc 30/01/05<br />

12184 Sol. Iodi Spirituosa jod Solution for veterinary<br />

use<br />

Biowet Drwalew 31/12/08<br />

12185 Soladen Adenosinum Solution for injection 3 mg/ml Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

12186 Solaren Curcumae rhizomae<br />

extractum<br />

Oral drops, solution Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

8/02/06<br />

30/10/05<br />

12187 Solcogyn Solution ICN Switzerland AG 15/11/06<br />

12188 SolcoKerasal Acidum salicylicum +<br />

Urea<br />

Ointment Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

12195 Solcoseryl Eye gel 8.3 mg/1g Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

12193 Solcoseryl Gel Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

30/06/05<br />

31/01/06<br />

31/01/06<br />

12194 Solcoseryl Gel ICN Switzerland AG 31/07/04<br />

12189 Solcoseryl Ointment Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

31/01/06<br />

12190 Solcoseryl Ointment ICN Switzerland AG 31/07/04<br />

12191 Solcoseryl Oromucosal paste ICN Switzerland AG 31/07/04<br />

12192 Solcoseryl Solution for<br />

intramuscular and<br />

intravenous injection<br />

42.5 mg/ml Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1273<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12196 SolcoTrichovac Suspension for<br />

intramuscular<br />

injection<br />

12197 Solfin Chlorek sodowy,<br />

Octan sodowy,<br />

Cytrynian sodowy,<br />

Chlorek wapniowy,<br />

Chlorek magnezu,<br />

Octan potasowy<br />

12198 Solganal susp. Aurothioglucosum Suspension for<br />

intramuscular<br />

injection<br />

Liquid for veterinary<br />

use<br />

0.5 ml ICN Switzerland AG 30/04/04<br />

Fresenius Kabi Polska 29/04/04<br />

50 mg/ml Schering-Plough Labo N.V. 31/05/04<br />

12203 Solian Amisulpridum Film-coated tablets 400 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

12/10/05<br />

12199 Solian Amisulpridum Oral solution 100 mg/ml Sanofi-Synthelabo France 14/03/07<br />

12200 Solian Amisulpridum Tablets 100 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

12201 Solian Amisulpridum Tablets 200 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

12202 Solian Amisulpridum Tablets 50 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

12/10/05<br />

12/10/05<br />

12/10/05<br />

12204 Solidago compositum S Amp. Heel GmbH 31/12/08<br />

12205 Solnasin 0,65 % Natrii chloridum Nasal drops, solution 6.5 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12206 Solnasin 0,65 % krople do<br />

nosa<br />

Zakłady Farmaceutyczne<br />

Polpharma SA, Starogard<br />

Gdański<br />

12207 Sol-Opht Preparat złoz˙ony Eye liquid Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12208 Solpadeine Codeinum + Coffeinum<br />

+ Paracetamolum<br />

12209 Solpadeine Capsules Codeinum + Coffeinum<br />

+ Paracetamolum<br />

12210 Solpadeine Tablets Codeinum + Coffeinum<br />

+ Paracetamolum<br />

Tablets 8mg + 30mg +<br />

500mg<br />

Capsules 8mg + 30mg +<br />

500mg<br />

Effervescent tablets 8mg + 30mg +<br />

500mg<br />

SmithKline Beecham<br />

Consumer Healthcare<br />

SmithKline Beecham<br />

Consumer Healthcare<br />

SmithKline Beecham<br />

Consumer Healthcare<br />

12211 Solpaflex Ibuprofenum Capsules 300 mg GlaxoSmithKline Consumer<br />

Healthcare<br />

12213 Solpaflex Ibuprofenum Gel GlaxoSmithKline Consumer<br />

Healthcare<br />

12212 Solpaflex Ibuprofenum Tablets 200 mg GlaxoSmithKline Consumer<br />

Healthcare<br />

12214 Solu Medrol Methylprednisolonum Lyophilisate for<br />

intramuscular and<br />

intravenous injection<br />

12215 Solu Medrol Methylprednisolonum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

12216 Solu Medrol Methylprednisolonum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

10/05/06<br />

31/12/08<br />

31/07/05<br />

31/07/05<br />

30/04/05<br />

30/04/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

250 mg Pharmacia N.V./S.A. 31/12/04<br />

1000 mg Pharmacia N.V./S.A. 30/06/04<br />

125 mg Pharmacia N.V./S.A. 30/06/04


EN<br />

1274 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12217 Solu Medrol Methylprednisolonum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

12218 Solu Medrol Methylprednisolonum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

12219 Solu-Decortin H 25 Prednisolonum Lyophilisate for<br />

injection<br />

40 mg Pharmacia N.V./S.A. 30/06/04<br />

500 mg Pharmacia N.V./S.A. 30/06/04<br />

25 mg/1 ml Merck KGaA 31/12/08<br />

12220 Soludor Lehning Laboratoires 31/12/08<br />

12221 Soludox 50 % Doxycyclinum Powder for veterinary<br />

use<br />

Eurovet 31/12/08<br />

12222 Solum Oil for rub (Rub oil) WALA-Heilmittel GmbH 24/05/07<br />

12223 Solum Uliginosum comp. Amp. 1 ml, 10 ml WALA-Heilmittel GmbH 24/05/07<br />

12224 Solum Uliginosum comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

12225 Soluprick SQ, Soluprick Alergeny diagnostyczne Solution Alk-Abello A/S 7/02/05<br />

12226 Solutio Acidi Borici 3 % Acidum boricum Coutanous liquid 30 mg/g Ichem Os´rodek Badawczo-<br />

Produkcyjny Politechniki<br />

Łódzkiej<br />

12<strong>227</strong> Solutio Chlorhexidini, Spiritus<br />

70°<br />

12228 Solutio Iodi cum Glyceroli<br />

(Płyn Lugola)<br />

Desinfection solution Laboratorium Galenowe<br />

Katowice<br />

Iodum + Kalii iodidum Coutanous liquid (10mg +<br />

20mg)/g<br />

Coel s.c.- Laboratorium<br />

Farmaceutyczne Wytwórnia<br />

Euceryny<br />

12229 Solutio Iodi Spirituosa 0,1 % Iodine + Kalii iodidum Liquid Laboratorium Galenowe<br />

Katowice<br />

12230 Solutio Pyoctanini 1 % Methylrosanilinii<br />

chloridum<br />

12231 Solutio Ringeri Calcii chloridum + Kalii<br />

chloridum + Natrii<br />

chloridum<br />

12232 Solutio Ringeri INJ. Chlorek sodu, Chlorek<br />

potasu, Chlorek<br />

wapnia,<br />

Coutanous liquid 10 mg/g Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

Solution for<br />

intravenous infusion<br />

Solution for veterinary<br />

use<br />

12233 Solutio Ringeri Lactate Solution for<br />

intravenous infusion<br />

12234 Soluvit N Multivitamins and trace<br />

elements<br />

Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

12235 Solvertyl Ranitidinum Solution for<br />

intramuscular and<br />

intravenous injection<br />

Fresenius Kabi Polska Sp. z<br />

o.o.<br />

31/01/06<br />

31/12/04<br />

30/04/05<br />

31/12/04<br />

13/07/05<br />

31/01/06<br />

Fresenius Kabi Polska 31/12/08<br />

Fresenius Kabi Polska Sp. z<br />

o.o.<br />

31/03/07<br />

Fresenius Kabi AB Uppsala 31/07/04<br />

25 mg/ml Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

14/12/05<br />

12236 Solvolan Ambroxolum Syrup 15 mg/5 ml Krka d.d., Novo mesto 31/12/08<br />

12237 Solvolan Ambroxolum Tablets 30 mg Krka d.d., Novo mesto 31/12/08<br />

12238 Soma Oral solution Varia — Zakłady Zielarsko-<br />

Farmaceutyczne Sp. z o.o.<br />

12239 Somatin Somatostatinum Powder for solution<br />

for injection and<br />

infusion<br />

30/10/05<br />

3 mg Torrex Pharma GmbH 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1275<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12240 Somatostatin-UCB Somatostatinum Lyophilisate for<br />

intravenous solution<br />

12241 Somatostatin-UCB Somatostatinum Lyophilisate for<br />

intravenous solution<br />

0.25 mg/1 ml UCB S.A. Pharma Sector 31/03/04<br />

3 mg/1 ml UCB S.A. Pharma Sector 31/03/04<br />

12242 Somatuline Autogel Lanreotidum Solution for injection 60 mg Ipsen — Biotech 31/12/08<br />

12243 Somatuline Autogel Lanreotidum Solution for injection 120 mg Ipsen — Biotech 31/12/08<br />

12244 Somatuline Autogel Laureotidum Solution for injection 90 mg Ipsen — Biotech 31/12/08<br />

12245 Somatuline PR Lanreotidum Powder and solvent<br />

for prolonged release<br />

suspension for<br />

intramuscular<br />

injection<br />

30 mg Ipsen Biotech 31/07/04<br />

12246 SOMNOL 7,5 mg Zopiclonum Film-coated tablets 7,5 mg Public Joint Stock Company<br />

‘Grindex’<br />

12247 Somnoten fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp.<br />

z o.o. — Zastawna<br />

12248 Somnubovin Surowica<br />

odpornos´ciowa<br />

przeciwko<br />

Haemophilius somnus<br />

12249 Somnuvac Inaktywowana<br />

szczepionka dla bydła<br />

przeciw zakaz˙eniom<br />

Haemophilus somnus<br />

Liquid for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

31/12/08<br />

30/10/05<br />

Pro animali 31/12/08<br />

Pro Animali Przedsie˛biorstwo<br />

Wdroz˙eniowo-Wytwórcze i<br />

Usługowe SP. z.o.o<br />

22/11/06<br />

12250 Sonata Zaleplonum Capsules, hard 10 mg Wyeth-Lederle GmbH 30/04/05<br />

12251 Sonata Zaleplonum Capsules, hard 5 mg Wyeth-Lederle GmbH 30/04/05<br />

12252 Songa Melissae folium<br />

extractum siccum +<br />

Valerianae radix<br />

extractum siccum<br />

12253 Songha Day Piperis methystici<br />

rhizomae extractum<br />

siccum<br />

Coated tablets Pharmaton S.A. 31/01/05<br />

Film-coated tablets 45 mg<br />

kawa-pironów<br />

Boehringer Ingelheim<br />

International GmbH<br />

12254 Sonna stres, syrop DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

12255 Sonol Coutanous liquid Elanda s.c. — Zakład<br />

Produkcji S´ rodków<br />

Farmaceutycznych<br />

12256 Sopodorm 15 Midazolamum Solution for<br />

intravenous and<br />

intramuscular<br />

injection<br />

12257 Sopodorm 2 Midazolamum Solution for<br />

intravenous or<br />

intramuscular<br />

injection<br />

12258 Sopodorm 5 Midazolamum Solution for<br />

intravenous or<br />

intramuscular<br />

injection<br />

12259 Sorbifer Durules Acidum ascorbicum (vit<br />

C) + Ferrosi sulfas<br />

7.5 mg/ml Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

1 mg/ml Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

2.5 mg/ml Solco Basel —<br />

Przedsie˛biorstwo Zagraniczne<br />

27/09/06<br />

24/11/05<br />

30/10/05<br />

31/01/05<br />

31/01/05<br />

31/01/05<br />

Film-coated tablets Egis Pharmaceuticals Ltd. 30/01/05


EN<br />

1276 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12260 Sorbonit Isosorbidi dinitras Tablets 10 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

12261 Sorbonit Isosorbidi dinitras Tablets 5 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

12262 Sorbonit prolongatum Isosorbidi dinitras Prolonged release<br />

tablets<br />

12263 Sorbonit prolongatum Isosorbidi dinitras Prolonged release<br />

tablets<br />

12264 Sorbonit prolongatum 80 Isosorbidi dinitras Prolonged release<br />

tablets<br />

20 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

40 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

80 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

31/01/06<br />

31/01/05<br />

31/01/06<br />

31/01/06<br />

28/02/06<br />

12266 Sorel Calcipotriolum Coutanous liquid 0,01 % Lek d.d. 31/12/08<br />

12265 Sorel Calcipotriolum Ointment 0,01 % Lek d.d. 31/12/08<br />

12267 Sorfox Isosorbidi mononitras Prolonged release<br />

tablets<br />

50 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

12268 Sortis 10 Atorvastatinum Film-coated tablets 10 mg Parke Davis GmbH 31/12/08<br />

12269 Sortis 20 Atorvastatinum Film-coated tablets 20 mg Parke Davis GmbH 31/12/08<br />

1<strong>227</strong>0 Sortis 40 Atorvastatinum Film-coated tablets 40 mg Parke Davis GmbH 31/12/08<br />

1<strong>227</strong>1 Sortis 80 Atorvastatinum Film-coated tablets 80 mg Pfizer Polska Sp. z o.o. 31/12/08<br />

1<strong>227</strong>2 Sotahexal Sotalolum Solution for injection 10 mg/ml Hexal AG 23/07/06<br />

1<strong>227</strong>3 Sotahexal 80 Sotalolum Tablets 80 mg Hexal AG 31/12/04<br />

1<strong>227</strong>4 Sotahexal 160 Sotalolum Tablets 160 mg Hexal AG 31/12/04<br />

1<strong>227</strong>5 Sotahexal 40 Sotaloli hydrochloridum Tablets 40 mg HEXAL AG 31/12/08<br />

1<strong>227</strong>6 Sotamerck 160 Sotalolum Tablets Merck Generics Limited 31/12/08<br />

1<strong>227</strong>7 Sotamerck 80 Sotalolum Tablets Merck Generics Limited 31/12/08<br />

1<strong>227</strong>8 Sotasec Szczepionka przeciw<br />

rzekomemu pomorowi<br />

drobiu dla kur,<br />

indyków i perliczek ,<br />

Lyophilisate for veterinary<br />

use<br />

Merial 30/06/04<br />

1<strong>227</strong>9 Sotret 10 Izotretinoinum Capsules, soft 10 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

12280 Sotret 20 Izotretinoinum Capsules, soft 20 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

12281 Soval Film-coated tablets Biokraft Pharma 30/06/04<br />

12282 Soventol Bamipini lactas Gel 20 mg/g Abbott GmbH & Co KG 31/08/04<br />

12283 Soyacal 10 % Sojae oleum Emulsion for infusion 100 mg/ml Laboratorios Grifols S.A. 31/12/08<br />

12284 Soyacal 20 % Sojae oleum Emulsion for infusion 200 mg/ml Laboratorios Grifols S.A. 31/12/08<br />

12285 Soyaprotect Soyae extractum Tablets 25 mg Medana Pharma Terpol<br />

Group S.A.<br />

12286 Soyaprotect-Meno Soyae extractum Tablets 60 mg Medana Pharma Terpol<br />

Group S.A.<br />

17/01/07<br />

17/01/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1277<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12287 Soyaprotect-osteo Sojae semen extractum<br />

siccum<br />

12288 Soyfem Glycine semen extractum<br />

siccum<br />

Tablets 25 mg<br />

izoflawonów<br />

12289 Soyfemina Glicinum Film-coated tablets preparat<br />

złoz˙ony<br />

Medana Pharma TERPOL<br />

Group S.A.<br />

Film-coated tablets 26 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

12290 Soyvit Gelatin capsules, hard 100 mg<br />

naturalnych<br />

izoflawonów<br />

sojowych<br />

12291 Sól Glauberska Natrii stearas Powder for veterinary<br />

use<br />

12292 Sól glauberska Natrii stearas Powder for veterinary<br />

use<br />

12293 Sól gorzka Magnesii stearas Powder for veterinary<br />

use<br />

31/12/08<br />

14/03/07<br />

US Pharmacia 31/12/08<br />

Farmina Sp. z o.o. 31/12/08<br />

Galvet 31/12/08<br />

Vetos-Farma 31/12/08<br />

PFO Vetos-Farma 24/07/07<br />

12294 Sól jodobromowa iwonicka Crystilline powder Uzdrowisko Iwonicz —<br />

Spółka Akcyjna<br />

12295 Spamilan Buspironum Tablets 10 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

12296 Spamilan Buspironum Tablets 5 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

12297 Spanidin Gusperimus Substance<br />

(lyophilisate) for<br />

solution for<br />

intravenous infusion<br />

12298 Spartrix Karnidazol Tablet for veterinary<br />

use<br />

31/01/06<br />

30/10/05<br />

30/10/05<br />

100 mg Nippon Kayaku Co. Ltd. 30/09/04<br />

Janssen 1/08/04<br />

12299 Spascupreel Amp. Heel GmbH 31/12/07<br />

12300 Spascupreel Tablets Heel GmbH 31/12/07<br />

12301 Spascupreel S Suppository Heel GmbH 31/12/08<br />

12302 Spasmalgon Fenpiverini bromidum +<br />

Metamizolum natricum<br />

+ Pitofenonum<br />

Solution for injection Pharmachim-Holding AD 30/04/05<br />

12303 Spasmex 15 Trospium Film-coated tablets 15 mg Dr R Pfleger Chemische<br />

Fabrik GmbH, Bamberg<br />

12304 Spasmex 5 Trospium Tablets 5 mg Dr R Pfleger Chemische<br />

Fabrik GmbH, Bamberg<br />

12305 Spasmium comp. Karoweryny<br />

chlorowodorek,<br />

Metamizol sodowy<br />

Liquid for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

Richter Pharma 31/12/08<br />

12306 Spasmo 6 Drotaverinum Tablets 40 mg Generox s.c. 31/12/08<br />

12307 Spasmolina Alverinum Capsuels, hard 60 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

12308 Spasmophen Oxyphenonii bromidum Tablets 5 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

30/06/06<br />

31/12/05


EN<br />

1278 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12309 Spasmophen duplex Oxyphenonii bromidum Film-coated tablets 10 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

12310 Spaspar Alverini citras +<br />

Paracetamolum<br />

Gelatin capsules 60 mg<br />

cytrynianu<br />

alweryny,<br />

200 mg<br />

paracetamolu<br />

Przedsie˛biorstwo<br />

Farmaceutyczno —<br />

Chemiczne ‘Synteza’ Sp. z<br />

o.o.<br />

31/12/05<br />

31/12/08<br />

12311 Spasticol Suppository Farmina Sp. z o.o. 31/01/06<br />

12312 Spastochol Preparat ziołowy Film-coated tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

10/05/06<br />

12313 Species nervinae F.Joh.Kwizda GmbH 31/12/08<br />

12314 Spectam Spektynomycinum Suspension for veterinary<br />

use<br />

12315 Spectam Inj. Spektynomycinum Solution for veterinary<br />

use<br />

12316 Spectolin Lincomycinum +<br />

Spektynomycinum<br />

12317 Spectolin 44 Lincomycinum +<br />

Neomycinum<br />

Solution for veterinary<br />

use<br />

Premix for veterinary<br />

use<br />

12318 Spektoriem Spectinomycinum Liquid for veterinary<br />

use<br />

Ceva Sante Animale 11/10/05<br />

Ceva Sante Animale 24/06/07<br />

Lek Pharmaceutical &<br />

Chemical Company d.d<br />

23/10/06<br />

Lek d.d. 31/12/08<br />

Riemser 31/12/08<br />

12319 Speridol Bisoprololum Tablets 5 mg Biochemie GmbH 31/12/08<br />

12320 Speridol Bisoprololum Tablets 10 mg Biochemie GmbH 31/12/08<br />

12321 Spersadexoline Chloramphenicolum +<br />

Dexamethasonum +<br />

Tetryzolinum<br />

12322 Spersallerg Antazolinum +<br />

Tetryzolinum<br />

12323 Spigella-Dagomed 20 bóle<br />

głowy<br />

Eye drops (5mg + 1mg +<br />

0,25mg)/ml<br />

Eye drops (0,05mg +<br />

0,04mg)/ml<br />

Novartis Ophthalmics AG<br />

Hettlingen<br />

Novartis Ophthalmics AG<br />

Hettlingen<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

31/07/04<br />

22/05/05<br />

31/01/06<br />

12324 Spigelon Amp. Heel GmbH 31/12/08<br />

12325 Spigelon Drops Heel GmbH 31/12/08<br />

12326 Spigelon Tablets Heel GmbH 31/12/08<br />

12327 Spiracol Collistinum +<br />

Spiramycinum<br />

Powder for veterinary<br />

use<br />

12328 Spiritus Camphoratus Camphorum Liquid for veterinary<br />

use<br />

Grodziskie Zakłady<br />

Farmaceutyczne Polfa<br />

Drwalewskie Zaklady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

12329 Spiriva Tiotropium Inhalation capsules 18 µg Boehringer Ingelheim<br />

International GmbH<br />

3/09/04<br />

31/12/08<br />

31/12/08<br />

12330 Spirolac Spironolactonum Tablets 25 mg Polfarmex S.A. 31/12/08<br />

12331 Spironol Spironolactonum Tablets 25 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

12332 Spironol 100 Spironolactonum Film-coated tablets 100 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/11/05<br />

1/07/06<br />

12333 Spironolacton 25 Spironolactonum Tablets 25 mg P.P.H.U. Biofarm Sp. z o.o. 31/12/08<br />

12334 Spiroratio Spironolactonum Tablets 100 mg ratiopharm GmbH 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1279<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12335 Spirytus kamforowy Camphorae spiritus Aflofarm Farmacja Polska,<br />

Pabianice<br />

5/08/05<br />

12336 Spirytus kamforowy Camphorae spiritus AUGMED, Dawidy Bankowe 5/08/05<br />

12337 Spirytus kamforowy Camphorae spiritus Avena, Bydgoszcz 5/08/05<br />

12338 Spirytus kamforowy Camphorae spiritus Cefarm Cze˛stochowa 5/08/05<br />

12339 Spirytus kamforowy Camphorae spiritus Cefarm Gdańsk 5/08/05<br />

12340 Spirytus kamforowy Camphorae spiritus Cefarm Szczecin 5/08/05<br />

12341 Spirytus kamforowy Camphorae spiritus Farmina Sp. z o.o., Kraków 5/08/05<br />

12342 Spirytus kamforowy Camphorae spiritus Felix Pharma, Lublin 5/08/05<br />

12343 Spirytus kamforowy Camphorae spiritus Hasco-Lek, Wrocław 5/08/05<br />

12344 Spirytus kamforowy Camphorae spiritus Herbapol Wrocław 5/08/05<br />

12345 Spirytus kamforowy Camphorae spiritus Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

5/08/05<br />

12346 Spirytus kamforowy Camphorae spiritus Labpharm-ATS, Brwinów 5/08/05<br />

12347 Spirytus kamforowy Camphorae spiritus Lefarm, Bydgoszcz 5/08/05<br />

12348 Spirytus kamforowy Camphorae spiritus Maga-Herba s.c., Legionowo 5/08/05<br />

12349 Spirytus kamforowy Camphorae spiritus Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

5/08/05<br />

12350 Spirytus kamforowy Camphorae spiritus PPF GEMI, Karczew 5/08/05<br />

12351 Spirytus kamforowy Camphorae spiritus PZF ‘Cefarm-Lublin’ S.A. 5/08/05<br />

12352 Spirytus kamforowy Camphorae spiritus Semifarm, Gdańsk 5/08/05<br />

12353 Spirytus kamforowy Camphorae spiritus Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

12354 Spirytus kamforowy Camphorae spiritus Zakład Farmaceutyczny<br />

Amara, Kraków<br />

12355 Spirytus kamforowy Camphorae spiritus Zakład Produkcyjno-<br />

Usługowy Farko s.c., Mrocza<br />

12356 Spirytus mrówczany Spiritus Formicicus Liquid Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

12357 Spirytus mrówczany Spiritus Formicicus Aflofarm Farmacja Polska,<br />

Pabianice<br />

5/08/05<br />

5/08/05<br />

5/08/05<br />

19/03/07<br />

19/03/07<br />

12358 Spirytus mrówczany Spiritus Formicicus Farmina Sp. z o.o., Kraków 19/03/07<br />

12359 Spirytus mrówczany Spiritus Formicicus Felix Pharma, Lublin 19/03/07<br />

12360 Spirytus mrówczany Spiritus Formicicus Herbapol Kraków 19/03/07<br />

12361 Spirytus mrówczany Spiritus Formicicus Maga-Herba s.c., Legionowo 19/03/07<br />

12362 Spirytus mrówczany Spiritus Formicicus Nobilus Ent, Warszawa 19/03/07<br />

12363 Spirytus mrówczany Spiritus Formicicus PPF GEMI, Karczew 19/03/07


EN<br />

1280 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12364 Spirytus mrówczany Spiritus Formicicus PZF ‘Cefarm-Lublin’ S.A. 19/03/07<br />

12365 Spirytus mrówczany Spiritus Formicicus Septoma, Za˛bki 19/03/07<br />

12366 Spirytus mrówczany Spiritus Formicicus Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

12367 Spirytus mrówczany Spiritus Formicicus Zakład Farmaceutyczny<br />

Amara, Kraków<br />

19/03/07<br />

19/03/07<br />

12368 Spirytus salicylowy Spiritus salicylatus Liquid Herbapol, Kraków 19/03/07<br />

12369 Spirytus salicylowy Spiritus salicylatus Aflofarm Farmacja Polska,<br />

Pabianice<br />

19/03/07<br />

12370 Spirytus salicylowy Spiritus salicylatus Avena, Bydgoszcz 19/03/07<br />

12371 Spirytus salicylowy Spiritus salicylatus Cefarm Gdańsk 19/03/07<br />

12372 Spirytus salicylowy Spiritus salicylatus Chema Elektromet, Rzeszów 19/03/07<br />

12373 Spirytus salicylowy Spiritus salicylatus Eko-Lek, Łabowa 19/03/07<br />

12374 Spirytus salicylowy Spiritus salicylatus Farmina Sp. z o.o., Kraków 19/03/07<br />

12375 Spirytus salicylowy Spiritus salicylatus Galenus, Rzeszów 19/03/07<br />

12376 Spirytus salicylowy Spiritus salicylatus Ichem, Łódz´ 19/03/07<br />

12377 Spirytus salicylowy Spiritus salicylatus Infarm, Gdynia 19/03/07<br />

12378 Spirytus salicylowy Spiritus salicylatus Jurbo-Agro, Wrocław 19/03/07<br />

12379 Spirytus salicylowy Spiritus salicylatus Laboratorium<br />

Farmaceutyczne Jarosław<br />

Szczepańczyk<br />

19/03/07<br />

12380 Spirytus salicylowy Spiritus salicylatus Labpharm-ATS, Brwinów 19/03/07<br />

12381 Spirytus salicylowy Spiritus salicylatus Lefarm, Bydgoszcz 19/03/07<br />

12382 Spirytus salicylowy Spiritus salicylatus Maga-Herba s.c., Legionowo 19/03/07<br />

12383 Spirytus salicylowy Spiritus salicylatus Medana Pharma Terpol<br />

Group, Sieradz<br />

19/03/07<br />

12384 Spirytus salicylowy Spiritus salicylatus Nobilus Ent, Warszawa 19/03/07<br />

12385 Spirytus salicylowy Spiritus salicylatus Prolab, Paterek k/Nakła 19/03/07<br />

12386 Spirytus salicylowy Spiritus salicylatus PZF ‘Cefarm-Lublin’ S.A. 19/03/07<br />

12387 Spirytus salicylowy Spiritus salicylatus Sana, Kłobuck 19/03/07<br />

12388 Spirytus salicylowy Spiritus salicylatus Semifarm, Gdańsk 19/03/07<br />

12389 Spirytus salicylowy Spiritus salicylatus Septoma, Za˛bki 19/03/07<br />

12390 Spirytus salicylowy Spiritus salicylatus Zakład Produkcyjno-<br />

Usługowy Farko s.c., Mrocza<br />

19/03/07<br />

12391 Spirytus salicylowy 2 % Spiritus salicylatus AUGMED, Dawidy Bankowe 4/06/07<br />

12392 Spirytus salicylowy 2 % Spiritus salicylatus Cefarm Cze˛stochowa 4/06/07<br />

12393 Spirytus salicylowy 2 % Spiritus salicylatus Felix-Pharma, Lublin 4/06/07<br />

12394 Spirytus salicylowy 2 % Spiritus salicylatus Hasco-Lek, Wrocław 4/06/07<br />

12395 Spirytus salicylowy 2 % Spiritus salicylatus Herbapol Wrocław 4/06/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1281<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12396 Spirytus salicylowy 2 % Spiritus salicylatus Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

12397 Spirytus salicylowy 2 % Spiritus salicylatus Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

4/06/07<br />

4/06/07<br />

12398 Spirytus salicylowy 2 % Spiritus salicylatus PPF GEMI, Karczew 4/06/07<br />

12399 Spirytus salicylowy 2 % Spiritus salicylatus Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

12400 Spirytus salicylowy 2 % Spiritus salicylatus Zakład Farmaceutyczny<br />

Amara, Kraków<br />

12401 Spirytus skaz˙ony hibitanem<br />

0.5 %<br />

12402 Spirytus skaz˙ony hibitanem<br />

0.5 %<br />

12403 Spirytus skaz˙ony hibitanem<br />

0.5 %<br />

12404 Spirytusowy Roztwór 70 %<br />

Rywanolu 0,1 %<br />

12405 Spirytusowy Roztwór Fioletu<br />

Gencjanowego 1 %<br />

12406 Spirytusowy Roztwór Fioletu<br />

Gencjanowego 2 %<br />

4/06/07<br />

4/06/07<br />

Labpharm ATS, Brwinów 30/11/05<br />

Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

Zakład Farmaceutyczny<br />

Amara, Kraków<br />

Ethacridini lactas Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

Methylrosanilinii<br />

chloridum<br />

Methylrosanilinii<br />

chloridum<br />

Coutanous liquid 10 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

Coutanous liquid 20 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

30/11/05<br />

30/11/05<br />

31/12/08<br />

30/01/05<br />

30/01/05<br />

12407 Spirytusowy roztwór jodu AUGMED, Dawidy Bankowe 30/06/05<br />

12408 Spirytusowy roztwór jodu Avena, Bydgoszcz 30/06/05<br />

12409 Spirytusowy roztwór jodu Cefarm Cze˛stochowa 30/06/05<br />

12410 Spirytusowy roztwór jodu Cefarm Gdańsk 30/06/05<br />

12411 Spirytusowy roztwór jodu Cefarm Szczecin 30/06/05<br />

12412 Spirytusowy roztwór jodu Farmina Sp. z o.o., Kraków 30/06/05<br />

12413 Spirytusowy roztwór jodu Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

30/06/05<br />

12414 Spirytusowy roztwór jodu Maga-Herba s.c., Legionowo 30/06/05<br />

12415 Spirytusowy roztwór jodu PPF GEMI, Karczew 30/06/05<br />

12416 Spirytusowy roztwór jodu PZF ‘Cefarm-Lublin’ S.A. 30/06/05<br />

12417 Spirytusowy roztwór jodu Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

12418 Spisytus kamforowy Camphorae spiritus Laboratorium<br />

Farmaceutyczne Jarosław<br />

Szczepańczyk<br />

30/06/05<br />

14/05/07<br />

12419 Spitrytus kamforowy Camphorae spiritus Nobilus Ent, Warszawa 24/03/06<br />

12420 SPONGIA comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

12421 SPONGIA comp. gran. WALA-Heilmittel GmbH 19/03/05


EN<br />

1282 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12422 Spongia-Dagomed 18<br />

nadczynnos´ć tarczycy<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

12425 Sporidex Cefalexinum Capsules 250 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

12426 Sporidex Cefalexinum Capsules 500 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

12423 Sporidex Cefalexinum Granules for<br />

suspension<br />

12424 Sporidex Cefalexinum Granules for<br />

suspension<br />

31/01/06<br />

26/06/07<br />

20/06/07<br />

125 mg/5 ml Ranbaxy Laboratoires Ltd. 31/12/08<br />

250 mg/5 ml Ranbaxy Laboratoires Ltd. 31/12/08<br />

12427 Sportenine Tablets Laboratoires BOIRON 30/05/06<br />

12428 Sportenine Powder for solution Laboratoires BOIRON 30/05/06<br />

12429 Sportenine koncentrat napoju Laboratoires BOIRON 30/05/06<br />

12430 Sportupac N Aescinum + Heparinum<br />

+ Hippocastani semen<br />

extractum siccum<br />

Ointment Terra-Bio-Chemie GmbH 14/03/07<br />

12431 Sportupac N liquid Terra-Bio-Chemie GmbH,<br />

Niemcy<br />

12432 Spraymadine C glicerol<br />

monolaurynianu, kwas<br />

kaprynowy, kwas<br />

kaprylowy<br />

12433 Sputolysin Dembreksyny<br />

chlorowodorek (sól<br />

jednowodna)<br />

12434 Squa-Med Pyrithionuim Zincum +<br />

Dinatrii undecylyloxyethylamidosulfosuccinas<br />

Liquid for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Cutaneous suspension (15mg +<br />

20mg)/g<br />

31/12/08<br />

Hypred 31/12/08<br />

Boehringer Ingelheim KG 20/04/06<br />

Permamed Laboratories Ltd. 30/09/04<br />

12435 Srebra azotan BUFA b.v. Pharmaceutical<br />

Products<br />

14/11/06<br />

12436 Srebra azotan Cefarm Wrocław 14/11/06<br />

12437 Srebra azotan Farm Impex, Gliwice 14/11/06<br />

12438 Srebra azotan Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

14/11/06<br />

12439 Srebra azotan Pharma Cosmetic, Kraków 14/11/06<br />

12440 Srebra azotan Pharma Zentrale 14/11/06<br />

12441 Srebra azotan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

12442 Srebra azotan PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

14/11/06<br />

14/11/06<br />

12443 Srebra proteinian Pharma Cosmetic, Kraków 31/12/08<br />

12444 Srebra proteinian Pharma Zentrale 31/12/08<br />

12445 Srebra proteinian PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

12446 Srebro koloidalne Pharma Cosmetic, Kraków 30/09/05<br />

12447 Srebro koloidalne Pharma Zentrale 30/09/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1283<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12448 Stagloban SHP Surowica<br />

odpornos´ciowa dla<br />

psów<br />

12449 Staloral Alergeny — mieszanki Solution for<br />

oromucosal or<br />

sublingual use<br />

12450 Staloral Alergeny grzybów<br />

ples´niowych,<br />

dermatofitów i droz˙dz˙y<br />

Solution for veterinary<br />

use<br />

Solution for<br />

oromucosal or<br />

sublingual use<br />

12451 Staloral Alergeny pyłków ros´lin Solution for<br />

oromucosal or<br />

sublingual use<br />

12452 Staloral Alergeny roztoczy kurzu<br />

domowego<br />

Solution for<br />

oromucosal or<br />

sublingual use<br />

12453 Staloral Alergeny siers´ci zwierza˛t Solution for<br />

oromucosal or<br />

sublingual use<br />

12454 Staloral 300 Mieszanki wycia˛gów<br />

alergenowych<br />

pochodzenia ros´linnego,<br />

roztoczy<br />

12455 Staloral 300 Wycia˛gi alergenowe<br />

pochodzenia ros´linnego<br />

12456 Staloral 300 Wycia˛gi alergenowe<br />

pochodzenia zwierze˛ca<br />

12457 Staloral 300 Wycia˛gi alergenowe<br />

roztoczy kurzu<br />

domowego<br />

12458 Stamaril Pasteur Vaccinum febris flavae<br />

vivum<br />

12459 Stamaril Pasteur Vaccinum febris flavae<br />

vivum<br />

12460 Stamaril Pasteur Vaccinum febris flavae<br />

vivum<br />

Solution for<br />

oromucosal or<br />

sublingual use<br />

Solution for<br />

oromucosal or<br />

sublingual use<br />

Solution for<br />

oromucosal or<br />

sublingual use<br />

Solution for<br />

oromucosal or<br />

sublingual use<br />

dawki<br />

podstawowe:<br />

10 IR/ml,<br />

300 IR/<br />

mldawki<br />

podtrzymuja˛ce:<br />

300 IR/ml<br />

dawki<br />

podstawowe:<br />

10 IR/ml,<br />

300 IR/<br />

mldawki<br />

podtrzymuja˛ce:<br />

300 IR/ml<br />

dawki<br />

podstawowe:<br />

10 IR/ml,<br />

300 IR/<br />

mldawki<br />

podtrzymuja˛ce:<br />

300 IR/ml<br />

dawki<br />

podstawowe:<br />

10 IR/ml,<br />

300 IR/<br />

mldawki<br />

podtrzymuja˛ce:<br />

300 IR/ml<br />

Intervet 18/12/05<br />

Stallergenes S.A. 31/08/05<br />

Stallergenes S.A. 31/08/05<br />

Stallergenes S.A. 31/08/05<br />

Stallergenes S.A. 31/08/05<br />

Stallergenes S.A. 31/08/05<br />

Stallergenes S.A. 31/12/08<br />

Stallergenes S.A. 31/12/08<br />

Stallergenes S.A. 31/12/08<br />

Stallergenes S.A. 31/12/08<br />

Lyophilisate 1 dawka Aventis Pasteur S.A. 31/12/06<br />

Lyophilisate 5 dawkowa Aventis Pasteur S.A. 31/12/06<br />

Lyophilisate 10 dawkowa Aventis Pasteur S.A. 31/12/06<br />

12461 Starazolin 0,05 % Tetryzolinum Eye drops 0.5 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

12462 Starlix Nateglinide Film-coated tablets 120 mg Novartis Pharma AG 27/09/06


EN<br />

1284 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12463 Starlix Nateglinide Film-coated tablets 180 mg Novartis Pharma AG 27/09/06<br />

12464 Starlix Nateglinide Film-coated tablets 60 mg Novartis Pharma AG 27/09/06<br />

12465 STATEX 10 mg Simvastatinum Film-coated tablets 10 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12466 STATEX 20 mg Simvastatinum Film-coated tablets 20 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12467 Stator 10 Atorvastatinum Film-coated tablets 10 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

12468 Stator 20 Atorvastatinum Film-coated tablets 20 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

12469 Stator 40 Atorvastatinum Film-coated tablets 40 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

12470 Statrol Neomycinum +<br />

Polymyxinum B<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Eye drops Alcon Couvreur N.V. 30/06/04<br />

12471 Stavaktiv Glucosaminum Film-coated tablets 750 mg US Pharmacia Sp. z o.o. 31/12/08<br />

12472 Staveran 40 Verapamilum Film-coated tablets 40 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12473 Staveran 80 Verapamilum Film-coated tablets 80 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12474 Staveran 120 Verapamilum Film-coated tablets 120 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12475 Staveran prolongatum Verapamilum Film-coated tablets 240 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12476 Staveran prolongatum Verapamilum Film-coated, prologed<br />

release tablets<br />

120 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

24/03/07<br />

30/10/05<br />

12477 Stavin Nabumetonum Film-coated tablets 500 mg Polfarmex S.A. 31/12/08<br />

12478 Stediril 30 Ethinylestradiolum +<br />

Levonorgestrelum<br />

12479 Stenorol Halofunginonu<br />

bromowodorek<br />

Coated tablets 30mcg +<br />

150mcg<br />

Powder for veterinary<br />

use<br />

Wyeth Pharma GmbH 30/04/04<br />

Intervet International B.V. 6/12/04<br />

12480 Steral Finasteridum Film-coated tablets 5 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

31/12/08<br />

12481 Steri-Neb Ipratropium Ipratropii bromidum Nebuliser solution 25 µg/ml Norton Healthcare Ltd. 31/12/08<br />

12482 Steri-Neb Salamol Salbutamolum Nebuliser solution 2.5 mg/2,5 ml Norton Healthcare Ltd. 30/09/07<br />

12483 Steri-Neb Salamol Salbutamolum Nebuliser solution 5 mg/2,5 ml Norton Healthcare Ltd. 30/09/07<br />

12484 Sterofundin Solution for infusion B. Braun Melsungen AG 14/02/07<br />

12485 Sterovag Formosulfathiazolum +<br />

Urea + Chloroxylenolum<br />

12486 Stibium metallicum<br />

praeparatum Mas´ć<br />

Pessary 300mg +<br />

50mg + 10 mg<br />

12487 Stieprox 1,5 % Ciclopiroxum Shampoo 1,5 %<br />

(0,015 mg)<br />

SecFarm — Towarzystwo<br />

Przemysłowo-Handlowe sp.<br />

z o.o. — Korkowa<br />

30/04/05<br />

WELEDA 24/08/05<br />

Stiefel Laboratoires 31/12/08<br />

12488 Stilnox Zolpidemi tartas Film-coated tablets 10 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

30/04/04<br />

12489 Stimulon Sertralinum Film-coated tablets 50 mg Egis Pharmaceuticals Ltd. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1285<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12490 Stimuno Phyllanthi herba<br />

extractum<br />

Capsules, hard 50 mg PT. Dexa Medica 31/12/08<br />

12492 Stocrin Efavirenzum Film-coated tablets 300 mg Merck Sharp & Dohme Idea<br />

Inc<br />

12493 Stocrin Efavirenzum Film-coated tablets 600 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

31/12/08<br />

31/12/08<br />

12491 Stocrin Efavirenzum Oral solution 30 mg/ml MSD Idea Inc. 21/03/07<br />

12494 Stocrin 100 Efavirenzum Capsules, hard 100 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

12495 Stocrin 200 Efavirenzum Capsules, hard 200 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

12496 Stocrin 50 Efavirenzum Capsules, hard 50 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

31/01/05<br />

31/01/05<br />

31/01/05<br />

12497 Stodal Granules Laboratoires BOIRON 31/12/07<br />

12498 Stodal Syrup Laboratoires BOIRON 31/12/07<br />

12499 Stomachol Oral drops Microfarm s.c.<br />

Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

12500 Stomasan Liquid Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

12501 Stomatosol Coutanous liquid Elanda s.c. — Zakład<br />

Produkcji S´ rodków<br />

Farmaceutycznych<br />

12502 Stomorgyl 20 Metronidazolum +<br />

Spiramycinum<br />

Tablet for veterinary<br />

use<br />

14/02/07<br />

31/12/08<br />

30/10/05<br />

Merial 12/07/06<br />

12503 Stoperan Loperamidum Capsules, hard 2 mg US Pharmacia Sp. z o.o. 31/12/08<br />

12504 Stopkatar Tetrahydrozolinum Nasal drops 0,05 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

12505 Stopkatar Tetrahydrozolinum Nasal drops 0,10 % Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/08<br />

31/12/08<br />

12506 Stoppot Methenaminum Coutanous powder Parafarm s.c. 31/05/06<br />

12507 Stra˛ki fasoli Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

12508 Strepfen Flurbiprofenum Buccal tablet 8.75 mg Boots Healthcare<br />

International<br />

12509 Strepsils Alcohol 2,4dichlorobenzylicus<br />

+<br />

Amylmethacresolum<br />

12510 Strepsils bez cukru ziołowocytrynowe<br />

12511 Strepsils Menthol and<br />

Eucalyptus<br />

12512 Strepsils with Honey and<br />

Lemon<br />

Alcohol 2,4dichlorobenzylicus<br />

+<br />

Amylmethacresolum<br />

Alcohol 2,4dichlorobenzylicus<br />

+<br />

Amylmethacresolum<br />

Alcohol 2,4dichlorobenzylicus<br />

+<br />

Amylmethacresolum<br />

Lozenge Boots Healthcare<br />

International<br />

Buccal lozenge Boots Healthcare<br />

International<br />

Lozenge Boots Healthcare<br />

International<br />

Lozenge Boots Healthcare<br />

International<br />

31/12/08<br />

24/08/05<br />

31/07/04<br />

31/12/08<br />

31/07/04<br />

31/07/04


EN<br />

1286 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12513 Strepsils with Vitamin C Alcohol 2,4dichlorobenzylicus<br />

+<br />

Acidum ascorbicum<br />

(vit C) +<br />

Amylmethacresolum<br />

12514 Streptase 1 500 000 Streptokinasum Powder for solution<br />

for intravenous and<br />

intramuscular<br />

injection or for<br />

suspension for<br />

intramuscular<br />

injection<br />

12515 Streptase 250000 Streptokinasum Powder for solution<br />

for intravenous and<br />

intraartery injection<br />

or for infusion<br />

Lozenge Boots Healthcare<br />

International<br />

12516 Strepto 25 % Streptomycyna Solution for veterinary<br />

use<br />

12517 Strepto 37,5 Streptomycinum Powder for veterinary<br />

use<br />

12518 Strepto 75 Streptomycyna Powder for veterinary<br />

use<br />

12519 Strepto Forte Streptomycyny<br />

siarczan,<br />

Dihydrostreptomycyny<br />

siarczan<br />

Solution for veterinary<br />

use<br />

12520 Streptokinase-Braun 1.500.000 Streptokinasum Lyophilisate for<br />

solution for<br />

intravenous or<br />

intraartery infusion<br />

12521 Streptokinase-Braun 250.000 Streptokinasum Lyophilisate for<br />

solution for<br />

intravenous or<br />

intraartery infusion<br />

12522 Streptokinase-Braun 750.000 Streptokinasum Lyophilisate for<br />

solution for<br />

intravenous or<br />

intraartery infusion<br />

12523 Streptokinaza Streptokinasum Powder for solution<br />

for intravenous or<br />

intraartery infusion<br />

12524 Streptokinaza Streptokinasum Powder for solution<br />

for intravenous or<br />

intraartery infusion<br />

12525 Streptomycin Sulphate Streptomycinum Substance for<br />

intramuscular<br />

injection<br />

12526 Streptomycinum Streptomycinum Powder for solution<br />

for intramuscular<br />

injection<br />

12527 Streptomycinum Streptomycyna Powder for veterinary<br />

use<br />

12528 Streptomycyna Streptomycyna Powder for veterinary<br />

use<br />

1500000 j.m. Hoechst Marion Roussel<br />

Deutschland GmbH<br />

250000 j.m. Hoechst Marion Roussel<br />

Deutschland GmbH<br />

31/07/04<br />

30/04/04<br />

30/04/04<br />

Norbrook 18/03/04<br />

Vetos-Farma 31/12/08<br />

Vetos-Farma 31/12/08<br />

Norbrook Lab. Ltd. 7/08/05<br />

1500000 j.m. B. Braun Melsungen AG 31/03/05<br />

250000 j.m B. Braun Melsungen AG 31/03/05<br />

750000 j.m B. Braun Melsungen AG 31/03/05<br />

1.5e+006 j.m. K and K medicplast 22/02/06<br />

250000 j.m. K and K medicplast 22/02/06<br />

1g Krasfarma S.A. 31/12/08<br />

1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne Polfa<br />

30/10/05<br />

12/11/06<br />

Vetos Farma 9/11/04<br />

12529 Streptomycyny siarczan Scholz, Sowin 31/01/06<br />

12530 Stres HomeoPorady Laboratoires BOIRON 30/06/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1287<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12531 Stres i kłopoty z zasypianiem<br />

HomeoPorady<br />

12532 Stresnil Azaperonum Solution for veterinary<br />

use<br />

12533 Stress — Plex — C Witaminy i Zn Film-coated tablets preparat<br />

złoz˙ony<br />

Laboratoires BOIRON 30/06/07<br />

Janssen Pharmaceutica 31/12/08<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

12534 Stresson Preparat odz˙ywczy Liquid Nutricia Export B.V 15/03/06<br />

12535 Strix Myrtilli frutus extractum<br />

+ Betacarotenum<br />

12536 Stronghold 12 % Selamektyna Solution for veterinary<br />

use<br />

12537 Stronghold 6 % Selamektyna Solution for veterinary<br />

use<br />

Tablets Ferrosan A/S 31/12/08<br />

Pfizer 8/09/05<br />

Pfizer 8/09/05<br />

12538 Strophantus compositum Amp. Heel GmbH 31/12/08<br />

12539 Structum Natrii chondroitini sulfas Capsules, hard 500 mg Pierre Fabre Medicament 31/12/08<br />

12540 Strumeel Tablets Heel GmbH 31/12/08<br />

12541 Strumeel Forte N Drops Heel GmbH 31/12/08<br />

12542 Stullmisan Kwiat rumianku, Lis´ć<br />

melisy, Ziele<br />

tysia˛cznika, Ziele<br />

piołunu, Kwiat arniki,<br />

Igły szczytowe gała˛zek<br />

sosny<br />

Powder for veterinary<br />

use<br />

12543 Suanovil 20 Spiramycinum Solution for veterinary<br />

use<br />

12544 Suanovil 50 Spiramycyna/kwas<br />

adypinowy<br />

Powder for veterinary<br />

use<br />

Richter Pharma 11/03/04<br />

Merial 25/05/04<br />

Merial 25/05/04<br />

12545 Succus Bardanae Bardanae radix succus Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

12546 Succus Betulae Betulae folium succus Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

12547 Succus Echinaceae Echinaceae purpureae<br />

herba succus<br />

Oral drops Phytopharm Kle˛ka S.A. 30/10/05<br />

12548 Succus Farfarae Farfarae folium succus Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

12549 Succus Hyperici Hyperici herba succus Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

12550 Succus Millefolii Millefolii herba succus Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

12551 Succus Plantaginis Plantaginis herba succus Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

12552 Succus Taraxaci Taraxaci radix succus Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

12553 Succus Urticae Urticae herba succus Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

12554 Sucralan Sucralfatum Tablets 1 g Lannacher Heilmittel GmbH 31/08/04<br />

12555 Sucralfate Sucralfatum Tablets 1 g Norton Healthcare Ltd. 30/06/04<br />

12556 Sucralfate, Gastrem Sucralfatum Suspension 1 g/5ml Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

12557 Sucralfate, Gastrem Sucralfatum Suspension 1 g/5ml Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

30/10/05<br />

30/10/05


EN<br />

1288 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12558 Sucralfate, Gastrem Sucralfatum Suspension 1 g/5ml Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

12559 Sudaclin Sulindacum Tablets 100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12560 Sudaclin Sulindacum Tablets 200 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12561 Sudafed Pseudoephedrinum Film-coated tablets 60 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

30/10/05<br />

31/12/07<br />

31/12/07<br />

12/10/05<br />

12562 Sufenta Sufentanilum Solution for injection 0.005 mg/ml Janssen-Cilag N.V. 24/05/06<br />

12563 Sufentanil Torrex Sufentanilum Solution for injection 5 µg/ml Torrex Pharma GmbH 31/12/08<br />

12564 Sufentanil Torrex Sufentanilum Solution for injection 10 µg/ml;<br />

ampułka 5 ml<br />

12565 Sufentanil Torrex Sufentanilum Solution for injection 10 µg/ml;<br />

ampułka 20 ml<br />

12566 Suibicol Zinci oxydum +<br />

Sulphaguanidinum<br />

12567 Suibiofer SE Inaktywowana<br />

surowica s´wiń z<br />

dodatkiem z˙elaza,<br />

selenu, miedzi i<br />

witamin z grupy B<br />

12568 Suidan Choriogonadotropina,<br />

Serogonadotropina<br />

12569 Suidestran Z˙elazo,<br />

Cjanokobalamina<br />

12570 Suiferon Inaktywowana<br />

surowica dla s´wiń<br />

12571 Suiferon Inaktywowana<br />

surowica s´wiń<br />

wzbogacona<br />

dodatkiem soli z˙elaza,<br />

miedzi, kobaltu, oraz<br />

witamin z grupy B, PP,<br />

pantotenianu wapnia<br />

12572 Suiferrin — pasta Z˙elazo, witamina e,<br />

b12<br />

12573 Suiferrovit Surowica s´wiń<br />

wzbogacona<br />

dekstranem z˙elaza, z<br />

dodatkiem soli miedzi,<br />

kobaltu i witamin z<br />

grupy B<br />

12574 Suigammin Gamma-globulina<br />

s´wińska dla prosia˛t<br />

12575 Suiglobin Surowica<br />

odpornos´ciowa dla<br />

prosia˛t<br />

12576 Suiherpesvac Szczepionka przeciw<br />

chorobie Aujeszky'ego<br />

dla s´wiń<br />

Powder for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Paste for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Torrex Pharma GmbH 31/12/08<br />

Torrex Pharma GmbH 31/12/08<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego Spółka<br />

Akcyjna<br />

31/12/07<br />

19/03/06<br />

Werfft-Chemie 21/05/04<br />

VETEM 4/03/04<br />

Dniepropietrowska<br />

Państwowa Biologiczna<br />

Fabryka<br />

18/09/07<br />

Zakłady Farm. Biowet 31/12/08<br />

Biowet Puławy 31/12/08<br />

Biowet Puławy 24/05/04<br />

Biowet Puławy 24/05/04<br />

Drwalewskie Zakłady Przem.<br />

Bioweterynaryjnego<br />

Państwowy Instytut<br />

Weterynaryjny<br />

31/12/08<br />

7/03/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1289<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12577 Suileptovac TPCI Inaktywowana<br />

szczepionka dla s´wiń<br />

przeciw leptospirozie<br />

12578 Suimicrovac Szczepionka przeciw<br />

chorobom wychowu<br />

ciela˛t<br />

12579 Suisaloral z˙ywa liofilizowana<br />

szczepionka dla s´wiń<br />

przeciwko zakaz˙eniom<br />

salonella cholerasuis<br />

Suspension for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Biowet Puławy 24/01/07<br />

Zakłady Farm. Biowet S.A. 31/12/08<br />

IDT 30/09/07<br />

12580 Sulfacetamidum Sulfacetamidum Eye drops 100 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12581 Sulfacetamidum 10 % H-E-C Eye drops 100 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

12582 Sulfacetamidum natricum Zakłady Farmaceutyczne<br />

Polpharma SA, Starogard<br />

Gdański<br />

30/10/05<br />

30/11/05<br />

31/12/07<br />

12583 Sulfaguanidinum A.C.E.F., Włochy 31/12/08<br />

12584 Sulfaguanidinum Pharma Cosmetic, Kraków 31/12/08<br />

12585 Sulfaguanidinum Pharma Zentrale 31/12/08<br />

12586 Sulfaguanidyna PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

12587 Sulfaguanidyna Zakłady Farmaceutyczne<br />

Polpharma SA, Starogard<br />

Gdański<br />

12588 Sulfanilamidum Zakłady Farmaceutyczne<br />

Polpharma SA, Starogard<br />

Gdański<br />

12589 Sulfanizolon Prednisolonum +<br />

Sulfacetamidum<br />

12590 Sulfarinol Naphazolinum +<br />

Sulfathiazolum<br />

Eye drops, suspension (2,5mg +<br />

100mg)/ml<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

Nasal drops Farmaceutyczno —<br />

Chemiczna Spółdzielnia Pracy<br />

Galenus<br />

24/07/06<br />

24/07/06<br />

31/12/07<br />

30/11/05<br />

31/12/08<br />

12591 Sulfasalazin Sulfasalazinum Film-coated tablets 500 mg Krka d.d., Novo mesto 31/07/04<br />

12592 Sulfasalazin EN Sulfasalazinum Film-coated tablets 500 mg Krka d.d., Novo mesto 31/07/04<br />

12593 Sulfasalazin En Sulfasalazinum Gastro-resistant<br />

tablets<br />

12594 Sulfatrim dla kotów Sulfametoksypirydazyna,<br />

Trimetoprim<br />

12595 Sulfatrim dla psów Sulfametoksypirydazyna,<br />

Trimetoprim<br />

12596 Sulfatyf Sól sodowa<br />

sulfachloropirazyny<br />

12597 Sulfazyna En Sulfasalazinum Gastro-resistant<br />

tablets<br />

12598 Sulfobituminiam amonowy Ammonii<br />

bituminosulfonas<br />

Tablet for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

500 mg Polfarmex S.A. 31/01/06<br />

Grodziskie Zakłady<br />

Farmaceutyczne Polfa<br />

Grodziskie Zakłady<br />

Farmaceutyczne Polfa<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

500 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

7/04/05<br />

7/04/05<br />

11/03/04<br />

31/12/08<br />

14/11/06


EN<br />

1290 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12599 Sulfobituminian amnowy Ammonii<br />

bituminosulfonas<br />

12600 Sulfobituminian amonowy Ammonii<br />

bituminosulfonas<br />

12601 Sulfobituminian amonowy Ammonii<br />

bituminosulfonas<br />

12602 Sulfobituminian amonowy Ammonii<br />

bituminosulfonas<br />

12603 Sulfobituminian amonowy Ammonii<br />

bituminosulfonas<br />

Labor, Wrocław 31/12/08<br />

BUFA b.v. Pharmaceutical<br />

Products<br />

31/01/06<br />

Pharma Cosmetic, Kraków 31/01/06<br />

Pharma Zentrale 31/01/06<br />

PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

12604 Sulfoguaiatussin Guaiacolsulfonatum Syrup Łódzkie Przedsie˛biorstwo<br />

Farmaceutyczne POLON Sp.<br />

z o.o.<br />

31/01/06<br />

31/12/08<br />

12605 Sulfogwajakol Pharma Zentrale 31/01/05<br />

12606 Sulfogwajakol PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/01/05<br />

12607 Sulfur complexe nr 12 Tablets Lehning Laboratoires 24/01/07<br />

12608 Sulfurcompositum-Heel Tablets Heel GmbH 31/12/07<br />

12609 SULPERAZON 1 g Cefoperazonum +<br />

Sulbactamum<br />

12610 SULPERAZON 2 g Cefoperazonum +<br />

Sulbactamum<br />

Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

500 mg +<br />

500 mg<br />

Pfizer Polska Sp. z o.o. 31/12/08<br />

1 g + 1 g Pfizer Polska Sp. z o.o. 31/12/08<br />

12611 Sulphodent Toothpaste Sulphur Zdrój Exim —<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

12612 Sulpiryd Sulpiridum Capsules 100 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12613 Sulpiryd Sulpiridum Capsules 50 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12614 Sulpiryd Sulpiridum Solution for<br />

intramuscular<br />

injection<br />

100 mg/2 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12615 Sulpiryd Sulpiridum Syrup 100 mg/5ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12616 Sulpiryd Sulpiridum Syrup 25 mg/5ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12617 Sulpiryd Sulpiridum Tablets 200 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12618 Sul-Tridin Trimethoprium +<br />

Sulphadiazinum<br />

12619 SUL-Tridin 24 % Sulphadiazinum +<br />

Trimethoprimum<br />

Suspension for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

5/07/06<br />

31/12/05<br />

31/12/05<br />

30/09/05<br />

31/12/05<br />

31/12/05<br />

31/12/05<br />

Norbrook 11/03/04<br />

Norbrook 21/05/04<br />

12620 Sumamed Azithromycinum Capsules 250 mg Pliva Farmaceutical, Chemical,<br />

Food and Cosmetic Industry<br />

Inc.<br />

31/05/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1291<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12621 Sumamed Azithromycinum Capsules 250 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12629 Sumamed Azithromycinum Film-coated tablets 125 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12630 Sumamed Azithromycinum Film-coated tablets 500 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12631 Sumamed Azithromycinum Film-coated tablets 600 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12622 Sumamed Azithromycinum Powder for solution<br />

for infusion<br />

12623 Sumamed Azithromycinum Powder for solution<br />

for infusion<br />

500 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

500 mg Pliva Farmaceutical, Chemical,<br />

Food and Cosmetic Industry<br />

Inc.<br />

12624 Sumamed Azithromycinum Syrup 0.1 g/5 ml Pliva Farmaceutical, Chemical,<br />

Food and Cosmetic Industry<br />

Inc.<br />

12625 Sumamed Azithromycinum Syrup 0.2 g/5 ml Pliva Farmaceutical, Chemical,<br />

Food and Cosmetic Industry<br />

Inc.<br />

12626 Sumamed Azithromycinum Syrup 100 mg/5ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12627 Sumamed Azithromycinum Tablets 125 mg Pliva Farmaceutical, Chemical,<br />

Food and Cosmetic Industry<br />

Inc.<br />

12628 Sumamed Azithromycinum Tablets 500 mg Pliva Farmaceutical, Chemical,<br />

Food and Cosmetic Industry<br />

Inc.<br />

12632 Sumamed forte Azithromycinum Syrup 200 mg/5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12633 Sumamigren Sumatriptanum Film-coated tablets 100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12634 Sumamigren Sumatriptanum Film-coated tablets 25 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12635 Sumamigren Sumatriptanum Film-coated tablets 50 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

12636 Super primrose oil Oenotherae paradoxa<br />

oleum<br />

12637 Supergestran Lecirelina Solution for veterinary<br />

use<br />

12638 Superoptim Hyperici herbae<br />

extractum siccum<br />

31/12/07<br />

29/06/05<br />

31/12/07<br />

31/12/08<br />

21/06/06<br />

21/06/06<br />

31/05/04<br />

31/05/04<br />

31/12/07<br />

31/05/04<br />

31/05/04<br />

31/12/07<br />

5/07/06<br />

5/07/06<br />

5/07/06<br />

Capsules, soft 1300 mg PRO NATURA s.j. 31/12/08<br />

Ferring-Leciva a.s. 5/08/06<br />

Film-coated tablets 75 mg Medana Pharma Terpol<br />

Group S.A.<br />

12639 Superossa Instant herbal tea Jiangxi Ning Hong Tea Group<br />

Co.<br />

12640 Suplemag B6 Capsules 82, 87 mg<br />

jonów<br />

magnezowych<br />

+ 5,0 witaminy<br />

B6<br />

Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

12641 Suplena Preparat odz˙ywczy Liquid Ross Products Division -<br />

Abbott Laboratories<br />

14/12/05<br />

31/07/05<br />

31/12/08<br />

31/07/04


EN<br />

1292 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12642 Supportan Alimentation liquid 546 kJ/100 ml Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

12643 Suppositoria<br />

antihaemorrhoidales<br />

12644 Supprestral Medroxyprogesteronum Tablet for veterinary<br />

use<br />

31/12/08<br />

Suppository Farmina Sp. z o.o. 31/12/04<br />

Vetoquinol S.A. 25/08/05<br />

12645 Supracyclin Tabs Doxycyclinum Tablets 100 mg Grünenthal GmbH 30/06/07<br />

12646 Supradyn Coated tablets Roche Consumer Health Ltd 31/05/04<br />

12647 Supradyn Effervescent tablets Roche Consumer Health Ltd 31/05/04<br />

12648 Suprane Desfluranum Inhalation solution Baxter S.A. 29/02/04<br />

12649 Supraviran Aciclovirum Cream 50 mg/g Grünenthal GmbH 31/12/04<br />

12651 Suprax Cefiximum Film-coated tablets 200 mg Gedeon Richter Ltd. 30/04/04<br />

12650 Suprax Cefiximum Powder for oral<br />

suspension<br />

100 mg/5ml Gedeon Richter Ltd. 30/04/04<br />

12652 Suprefact Depot Buserelinum Implant Hoechst Marion Roussel<br />

Deutschland GmbH<br />

12653 Supremin Butamiratum Oral drops, solution 5 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12654 Supremin Butamiratum Syrup 4 mg/5 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12655 Suramox 50 % OSP Amoxicillunum Powder for veterinary<br />

use<br />

12656 Suramox PM 5 % Amoxicillunum Premix for veterinary<br />

use<br />

31/12/08<br />

27/06/07<br />

27/06/07<br />

Ceva Sante Animale 31/12/08<br />

Virbac S.A. 20/10/05<br />

12657 Suratio 1000 Sucralfatum Tablets 1 g ratiopharm GmbH 31/07/04<br />

12659 Surgam Acidum tiaprofenicum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

200 mg Roussel Laboratories 30/04/04<br />

12658 Surgam Acidum tiaprofenicum Suppository 0.3 g Roussel Laboratories 30/04/04<br />

12660 Surgam Acidum tiaprofenicum Tablets 300 mg Roussel Laboratories 30/04/04<br />

12661 Surolan Miconazolum +<br />

Polimixinum B +<br />

Prednisolonum<br />

12662 Surowica przeciw ws´ciekliz´nie Rabies serum Solution for<br />

intramuscular<br />

injection<br />

Suspension for veterinary<br />

use<br />

12663 Survanta Beractantum Endotracheopulmonary<br />

suspension<br />

Janssen 17/08/04<br />

1000 j.m./5ml Aventis Pasteur S.A. 29/02/04<br />

0.2 g/8 ml Abbott Laboratories 31/12/07<br />

12664 Survimed Banane Powder Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

12665 Survimed<br />

OchsenschwanzSuppe<br />

Powder Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

12666 Survimed Opd Dieta płynna Alimentation liquid Fresenius Kabi Deutschland<br />

GmbH<br />

12667 Sustonit Glyceroli trinitras Prolonged release<br />

tablets<br />

15 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/07/04<br />

31/07/04<br />

31/12/08<br />

31/12/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1293<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12668 Sustonit Glyceroli trinitras Prolonged release<br />

tablets<br />

12669 Suvaxyn M.hyo szczepionka dla s´wiń<br />

przeciw zakaz˙eniom<br />

wywołanym przez<br />

mycoplasma<br />

hyopneumonia<br />

Suspension for veterinary<br />

use<br />

6.5 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05<br />

Fort Dodge 31/12/08<br />

12670 Sweet dreams Tablets Ameri Vita LLC USA 31/12/08<br />

12671 Swish Allorganic Instant Hand<br />

Sanitizer z˙el do dezynfekcji ra˛k<br />

12672 Syginfar (poprzednia nazwa:<br />

immuplant)<br />

Eleuterococci radix<br />

extractum siccum<br />

Swish Maintenance 14/05/06<br />

Film-coated tablets 100 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

12673 Sylax Powder 3 g Krotex 31/12/08<br />

12674 Sylax forte Plantago ovatae testa,<br />

Sennae fructus extractum<br />

siccum<br />

Powder for oral<br />

suspension<br />

Krotex Poland Ltd. 31/12/08<br />

12675 Sylax plus Powder Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12676 Sylicholin Capsule, hard preparat<br />

złoz˙ony<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

12677 Sylicynar Preparat ziołowy Film-coated tablets Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

12678 Sylidor Sylibinum marinum Film-coated tablets preparat<br />

złoz˙ony<br />

12679 Syliflex Phospholipidum ex soyae<br />

+ Silymarynum<br />

31/12/08<br />

31/12/08<br />

30/10/05<br />

US Pharmacia 31/12/08<br />

Film-coated tablets 100 mg Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

31/12/08<br />

12680 Syligran Preparat ziołowy Herbal granules Herbapol Łódz´ S.A. 30/10/05<br />

12681 Syligranex Preparat złoz˙ony Tablets ‘HERBAPOL — ŁÓDZ´ ’ S.A. 31/12/08<br />

12682 Sylimarol Silibi mariani extractum Oral suspension Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

12683 Sylimarol 35 mg Silibininum Coated tablets 35 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

12684 Sylimarol 70 mg Silibininum Coated tablets 70 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

30/10/05<br />

1/04/05<br />

30/10/05<br />

12685 Sylimax 100 Sylimarynum Capsules 149 mg Herbapol — Lublin S.A. 31/12/08<br />

12686 Sylimax Comp. Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

12687 Sylimax Forte Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

12688 Syliverin Silymarinum Tablets 70 mg AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

12689 Sylivit Prep. witaminowy z<br />

sylimaryna˛<br />

12690 Sylivit 80 Prep. witaminowy z<br />

sylimaryna˛<br />

12691 Sylivit 150 Prep. witaminowy z<br />

sylimaryna˛<br />

Film-coated tablets Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

Capsules, hard 80 mg Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

Capsules, hard Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

31/12/08<br />

31/01/05<br />

30/09/07<br />

30/09/07


EN<br />

1294 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12692 Symbicort Turbuhaler Budesonidum +<br />

Formoterolum<br />

12693 Symbicort Turbuhaler Budesonidum +<br />

Formoterolum<br />

Powder nebuliser (80mcg +<br />

4,5mcg)/dawke˛<br />

inhalacyjna˛<br />

Powder nebuliser (160mcg +<br />

4,5mcg)/<br />

dawke˛<br />

inhalacyjna˛<br />

AstraZeneca AB 24/05/06<br />

AstraZeneca AB 24/05/06<br />

12694 Sympal 25 Dexketoprofenum Film-coated tablets 25 mg BERLIN — CHEMIE AG<br />

(Menarini Group)<br />

12695 Sympathyl® Eschscholtziae ext. sic +<br />

Crataegi inf. extr. siccum<br />

+ Magnesium oxydatum<br />

Film-coated tablets (20 mg +<br />

75 mg +<br />

75 mg Mg)<br />

31/12/08<br />

Innothera Chouzy 31/12/08<br />

12696 Symphytum comp. Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

12697 Symphytum comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

12698 Synacthen Tetracosactidum Solution for injection 250 mcg/1 ml Novartis Pharma AG 31/05/04<br />

12699 Synacthen Depot Tetracosactidum Solution for injection 1 mg/1 ml Novartis Pharma AG 31/05/04<br />

12700 Synagis Palivizumabum Powder and solvent<br />

for solution for<br />

injection<br />

12701 Synagis Palivizumabum Powder and solvent<br />

for solution for<br />

injection<br />

12702 Synarel Nafarelinum Nasal spray, solution 200 mcg/<br />

dawke˛<br />

donosowa˛<br />

12703 Synchromate Kloprostenol Solution for veterinary<br />

use<br />

100 mg Abbott Laboratories Ltd. 31/07/05<br />

50 mg Abbott Laboratories Ltd. 31/07/05<br />

Searle Division of Monsanto<br />

plc.<br />

30/06/07<br />

Bremer Pharma 18/09/05<br />

12704 Syncumar Acenocoumarolum Tablets 4 mg ICN Alkaloida Hungary<br />

Company Limited,<br />

Tiszavasvari<br />

12705 Synercid Dalfopristinum +<br />

Quinupristinum<br />

12706 Synergal Inj. Acidum clavulanicum<br />

+ Amoxicillinum<br />

12707 Synergal LC Acidum clavulanicum<br />

+ Amoxicillinum +<br />

Prednisolonum<br />

12708 Synergal Tabl. 250 mg Acidum clavulanicum<br />

+ Amoxicillinum<br />

12709 Synergal Tabl. 50 mg Acidum clavulanicum<br />

+ Amoxicillinum<br />

12710 Synparv-Syva Szczepionka przeciw<br />

parwowirozie s´wiń<br />

12711 Synphase Ethinylestradiolum +<br />

Norethisteronum<br />

Powder for solution<br />

for infusion<br />

Suspension for veterinary<br />

use<br />

Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

Tablets for veterinary<br />

use<br />

Tablets for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Tablets 0,035mg +<br />

0,5mg lub<br />

0,035 + 1mg<br />

31/07/04<br />

Rhône-Poulenc Rorer 23/03/05<br />

Norbrook 31/12/08<br />

Norbrook 31/12/08<br />

Norbrook 31/12/08<br />

Norbrook 31/12/08<br />

Laboratorios Syva 13/10/04<br />

Searle Division of Monsanto<br />

plc.<br />

12712 Syntaris Flunisolidum Nasal spray, solution 0.25 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

12715 Syntarpen Cloxacillinum Film-coated tablets 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/05/04<br />

30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1295<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12713 Syntarpen Cloxacillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

12714 Syntarpen Cloxacillinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

12716 Syntarpen Cloxacillinum Intramammary<br />

suspension<br />

12717 Syntarpen prolongatum Cloxacillinum Intramammary<br />

suspension<br />

1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

for veterinary<br />

use<br />

for veterinary<br />

use<br />

17/01/07<br />

30/10/05<br />

Biowet Puławy 3/09/04<br />

Biowet Puławy 22/10/04<br />

12718 Syntemucol, Acetylocysteina Acetylcysteinum Capsules 100 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

12719 Syntemucol, Acetylocysteina<br />

0,2<br />

12720 Synulox tabletki 50 mg Acidum clavulanicum<br />

+ Amoxicillinum<br />

12721 Synulox iniekcja Acidum clavulanicum<br />

+ Amoxicillinum<br />

12722 Synulox krople Acidum clavulanicum<br />

+ Amoxicillinum<br />

12723 Synulox L.C. Acidum clavulanicum<br />

+ Amoxicillinum +<br />

Prednisolonum<br />

12724 Synulox Tabletki 250 mg Acidum clavulanicum<br />

+ Amoxicillinum<br />

12725 Synulox tabletki 500 mg Acidum clavulanicum<br />

+ Amoxicillinum<br />

Acetylcysteinum Capsuels, hard 200 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

Tablet for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Intramammary<br />

suspension<br />

for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

31/07/05<br />

30/09/05<br />

Pfizer Italia S.r.I. 31/12/08<br />

Pfizer Italia S.r.I. 31/12/08<br />

Pfizer Italia S.r.I. 31/12/08<br />

Pfizer Italia S.r.I. 6/08/05<br />

Pfizer Italia S.r.I. 31/12/08<br />

Pfizer S.r.I. 31/12/08<br />

12726 Synvisc Acidum hyaluronicum Solution for injection 16 mg/2 ml Genzyme Biosurgery 12/10/05<br />

12727 Syp cebulowy Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

12728 Syromin Forte Film-coated tablets 100 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

31/12/08<br />

31/12/08<br />

12729 Syrop malinowy PPF GEMI, Karczew 31/08/05<br />

12730 Syrop moczope˛dny Syrup WALA-Heilmittel GmbH 24/05/07<br />

12731 Syrop prawos´lazowy Althaeae sirupus Syrup PPF GEMI, Karczew 19/04/07<br />

12732 Syrop prawos´lazowy Althaeae sirupus Aflofarm Farmacja Polska,<br />

Pabianice<br />

19/04/07<br />

12733 Syrop prawos´lazowy Althaeae sirupus Avena, Bydgoszcz 19/04/07<br />

12734 Syrop prawos´lazowy Althaeae sirupus Cefarm Gdańsk 19/04/07<br />

12735 Syrop prawos´lazowy Althaeae sirupus Hasco-Lek, Wrocław 19/04/07<br />

12736 Syrop prawos´lazowy Althaeae sirupus Lefarm, Bydgoszcz 19/04/07<br />

12737 Syrop prawos´lazowy Althaeae sirupus Maggie, Warszawa 19/04/07<br />

12738 Syrop prawos´lazowy Althaeae sirupus Polfarmex, Kutno 19/04/07<br />

12739 Syrop prawos´lazowy Althaeae sirupus PPF GEMI, Karczew 19/04/07


EN<br />

1296 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12740 Syrop prawos´lazowy Althaeae sirupus PPF GEMI, Karczew 19/04/07<br />

12741 Syrop prawos´lazowy Althaeae sirupus Prolab, Paterek k/Nakła 19/04/07<br />

12742 Syrop prawos´lazowy Althaeae sirupus Vis, Katowice 19/04/07<br />

12743 Syrop prawos´lazowy Althaeae sirupus Zakład Farmaceutyczny<br />

Amara, Kraków<br />

12744 Syrop prawos´lazowy z<br />

miodem<br />

Syrup Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

12745 Syrop Prawos´lazowy złoz˙ony Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

19/04/07<br />

31/12/08<br />

31/12/07<br />

12746 Syrop sosnowy złoz˙ony Syrup Herbapol Lublin S.A. 31/08/05<br />

12747 Syrop sosnowy złoz˙ony Syrup Aflofarm Farmacja Polska Sp.<br />

z o.o.<br />

12748 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12749 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12750 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12751 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12752 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12753 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12754 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12755 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12756 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12757 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12758 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12759 Syrop tymiankowy złoz˙ony Thymi sirupus<br />

compositus<br />

12760 Syrop z babki Plantaginis extractum<br />

fluidum<br />

Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/08/05<br />

31/05/07<br />

Cefarm Gdańsk 31/05/07<br />

Hasco-Lek, Wrocław 31/05/07<br />

Herbapol Lublin 31/05/07<br />

Herbapol Wrocław 31/05/07<br />

Lefarm, Bydgoszcz 31/05/07<br />

Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

31/05/07<br />

Phytopharm Kle˛ka S.A. 31/05/07<br />

Polfarmex, Kutno 31/05/07<br />

PPF GEMI, Karczew 31/05/07<br />

Prolab, Paterek k/Nakła 31/05/07<br />

Zakład Farmaceutyczny<br />

Amara, Kraków<br />

31/05/07<br />

Syrup Phytopharm Kle˛ka S.A. 31/12/08<br />

12761 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Syrup Galena, Wrocław 17/09/07<br />

12762 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Aflofarm Farmacja Polska,<br />

Pabianice<br />

17/09/07<br />

12763 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Cefarm Gdańsk 17/09/07<br />

12764 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Farmapol, Poznań 17/09/07<br />

12765 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Galena, Wrocław 17/09/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1297<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12766 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Hasco-Lek, Wrocław 17/09/07<br />

12767 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Herbapol Wrocław 17/09/07<br />

12768 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Lefarm, Bydgoszcz 17/09/07<br />

12769 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

17/09/07<br />

12770 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Polfarmex, Kutno 17/09/07<br />

12771 Syrop z sulfogwajakolem Sulfogaiacoli sirupus PPF GEMI, Karczew 17/09/07<br />

12772 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Prolab, Paterek k/Nakła 17/09/07<br />

12773 Syrop z sulfogwajakolem Sulfogaiacoli sirupus Zakład Farmaceutyczny<br />

Amara, Kraków<br />

12774 Syscor CC 10 Nisoldipinum Film-coated, prologed<br />

release tablets<br />

12775 Syscor CC 20 Nisoldipinum Film-coated, prologed<br />

release tablets<br />

12776 Syscor CC 30 Nisoldipinum Film-coated, prologed<br />

release tablets<br />

12777 Syscor CC 40 Nisoldipinum Film-coated, prologed<br />

release tablets<br />

12778 Systamex Oksfendazol Suspension for veterinary<br />

use<br />

17/09/07<br />

10 mg Bayer AG 31/01/05<br />

20 mg Bayer AG 31/01/05<br />

30 mg Bayer AG 31/01/05<br />

40 mg Bayer AG 31/01/05<br />

Zakłady Farmaceutyczne<br />

‘Biowet’<br />

7/07/04<br />

12779 Systen 100 Estradiolum Transdermal pach Cilag AG 31/12/08<br />

12780 Systen 25 Estradiolum Transdermal pach Cilag AG 31/12/08<br />

12781 Systen 50 Estradiolum Transdermal patch 3,2mg;<br />

50 mcg/24 h<br />

Cilag AG 30/06/04<br />

12782 Systen 75 Estradiolum Transdermal pach Cilag AG 31/12/08<br />

12783 Systen Conti Estradiolum +<br />

Norethisteronum<br />

12784 Systen Sequi Estradiolum +<br />

Norethisteronum<br />

Transdermal patch 3,2mg (50mcg/<br />

24h) + 11,2mg<br />

(170mcg/24h)<br />

Transdermal patch 1) Systen 50<br />

— 3,2mg<br />

(50mcg/24h),<br />

2) Systen Conti<br />

3,2mg (50mcg/<br />

24h) i 11,2mg<br />

(170mcg/24h)<br />

Cilag AG 30/11/04<br />

Cilag AG 30/11/04<br />

12785 Syzygium Compositum Drops Heel GmbH 31/12/08<br />

12786 Szampon p/łupiez˙owy Kaja Shampoo Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

12787 Szczepionka durowo-te˛z˙cowa<br />

(TyT)<br />

12788 Szczepionka przeciw Cholerze Cholera, inactivated,<br />

whole cell<br />

Suspension for<br />

subcutaneous<br />

injection<br />

Suspension for<br />

subcutaneous<br />

injection<br />

20 dawek Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

30/10/05<br />

30/10/05<br />

30/10/05


EN<br />

1298 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12789 Szczepionka przeciwgruz´licza<br />

BCG 10<br />

12790 Szczepionka przeciwgruz´licza<br />

BCG 20<br />

12791 Szczepionka te˛z˙cowa<br />

adsorbowana (T)<br />

12792 Szczepionka te˛z˙cowa<br />

adsorbowana (T)<br />

12793 Szczepionka te˛z˙cowa<br />

adsorbowana (T)<br />

Tuberculinum Lyophilisate and<br />

solvent for<br />

suspenision for<br />

intracutaneous<br />

injection<br />

Tuberculinum Lyophilisate and<br />

solvent for<br />

suspenision for<br />

intracutaneous<br />

injection<br />

Tetanus antitoxin Solution for<br />

subcutaneous<br />

injection<br />

Tetanus antitoxin Solution for<br />

subcutaneous<br />

injection<br />

Tetanus antitoxin Solution for<br />

subcutaneous<br />

injection<br />

10 dawek Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

20 dawek Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

40 j.m./0,5 ml Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

40 j.m./1 ml Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

40 j.m./1 ml Biomed Wytwórnia Surowic i<br />

Szczepionek — Warszawa<br />

12794 Sztyft do nosa VIPS Nasal stick Topchem — Przemysłowo-<br />

Handlowa Sp. z o.o.<br />

12795 Szyszka chmielu Lupuli strobilus Herb A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

30/10/05<br />

31/08/05<br />

31/08/05<br />

31/08/05<br />

31/08/05<br />

31/05/06<br />

19/07/07<br />

12796 Szyszka chmielu 1 Lupuli strobilus Herbapol Kraków 19/12/06<br />

12797 Szyszki Chmielu Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

12798 Szyszki Chmielu Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/10/05<br />

30/10/05<br />

12799 Szyszki Chmielu Herb Herbapol Lublin S.A. 30/10/05<br />

12800 Szyszki Chmielu - Strobilus<br />

Lupuli<br />

Herb Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

12801 Szyszkojagoda jałowca 1 Zioła lecznicze Boguccy,<br />

Kraków<br />

31/12/06<br />

31/12/05<br />

12802 Szyszkojagoda jałowca 1 i 2 Herbalux, Warszawa 16/06/06<br />

12803 S´ wietlik krople do oczu Decymal, Gdańsk 8/08/05<br />

12804 Tabcin Paracetamolum Powder for oral<br />

solution<br />

500 mg Bayer AG 31/08/04<br />

12805 Tabcin Impakt Preparat złoz˙ony Gelatin capsules Bayer Corporation 31/08/04<br />

12806 Tabcin Trend Chlorpheniraminum +<br />

Paracetamolum +<br />

Pseudoephedrinum<br />

Gelatin capsules 2mg + 250mg<br />

+ 30mg<br />

Bayer Corporation 31/08/04<br />

12807 Tabex Film-coated tablets 1.5 mg Pharmachim-Holding AD 30/04/05<br />

12808 Tabitil Pseudoephedrinum Film-coated tablets 60 mg US Pharmacia 31/12/08<br />

12809 Tabletki od bólu głowy<br />

ANAPIRYNA<br />

Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Ethenzamidum<br />

12810 Tabletki przeciw grypie Acidum acetylsalicylicum<br />

+ Coffeinum<br />

Tablets 300mg +<br />

50mg +<br />

100mg<br />

Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/12/08<br />

30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1299<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12811 Tabletki przeciw grypie Acidum acetylsalicylicum<br />

+ Coffeinum<br />

12812 Tabletki Przeciw Grypie Acidum acetylsalicylicum,<br />

Coffeinum<br />

Tablets Cyntfarm Sp. z o.o. 30/04/05<br />

Zakład Produkcji Chemiczno<br />

— Farmaceutycznej s.c.<br />

‘CHANCE’, Łomianki<br />

12813 Tabletki przeciw niestrawnosci Tablets Labofarm — Innowacyjno-<br />

Wdroz˙eniowe Laboratorium<br />

Farmaceutyczne<br />

12814 Tabletki raunatiny Film-coated tablets ONP Borszczagowski Zakład<br />

Chemiczno Farmaceutyczny,<br />

Ukraina<br />

12815 Tabletki Rzewieniowe Tablets 0.5 g Laboratorium<br />

Farmaceutyczne mgr farm.<br />

Zofia Sadowska<br />

12816 Tabletki tonizuja˛ce Tablets Labofarm — Innowacyjno-<br />

Wdroz˙eniowe Laboratorium<br />

Farmaceutyczne<br />

12817 Tabletki uspokajaja˛ce Tablets Labofarm — Innowacyjno-<br />

Wdroz˙eniowe Laboratorium<br />

Farmaceutyczne<br />

12818 Tabletki wycia˛gu kozłkowego ONP Borszczagowski Zakład<br />

Chemiczno Farmaceutyczny,<br />

Ukraina<br />

12819 Tabletki z czosnku Allii sativi bulbus Tablets 300 mg Labofarm — Innowacyjno-<br />

Wdroz˙eniowe Laboratorium<br />

Farmaceutyczne<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

31/12/07<br />

31/01/06<br />

30/10/05<br />

31/12/08<br />

30/10/05<br />

12820 Tabulettae laxantes Tablets ICN Polfa Rzeszów S.A. 30/10/05<br />

12824 Taclar Clarithromycinum Film-coated tablets 250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12821 Taclar Clarithromycinum Granules for oral<br />

solution<br />

12822 Taclar Clarithromycinum Granules for oral<br />

solution<br />

12823 Taclar Clarithromycinum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

12825 Tad 300 Glutathionum powder and solvent<br />

for solution for<br />

intramuscular and<br />

intravenous injection<br />

12826 Tad 600 Glutathionum powder and solvent<br />

for solution for<br />

intramuscular and<br />

intravenous injection<br />

12827 TAD AE vac Z˙ywa szczepionka dla<br />

kur przeciw<br />

zakaz´nemu zapaleniu<br />

mózgu i rdzenia<br />

kre˛gowego ptaków<br />

12828 TAD Gumboro vac Szczepionka przeciw<br />

chorobie Gumboro dla<br />

kurcza˛t<br />

Suspension for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

125 mg/5 ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

250 mg/5 ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

24/05/06<br />

300 mg Biomedica Foscama S.p.A. 31/12/08<br />

600 mg Biomedica Foscama S.p.A. 31/12/08<br />

Lohmann Animal Health<br />

GmbH & Co. KG<br />

6/06/07<br />

Lohmann Animal Health 6/12/04


EN<br />

1300 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12829 TAD IB/ND vac La Sota Szczepionka dla<br />

kurcza˛t przeciw<br />

zakaz´nemu zapaleniu<br />

oskrzeli, rzekomemu<br />

pomorowi drobiu<br />

12830 TAD ILT vac Szczepionka dla<br />

kurcza˛t przeciw<br />

zakaz´nemu zapaleniu<br />

krtani i tchawicy<br />

12831 TAD ND vac HB1 Szczepionka przeciw<br />

rzekomemu pomorowi<br />

drobiu<br />

12832 TAD ND vac LaSota Szczepionka dla<br />

drobiu przeciwko<br />

rzekomemu pomorowi<br />

drobiu<br />

12833 TAD Pox Vac Szczepionka dla kur<br />

przeciwko ospie<br />

12834 TAD Reo Vac I Szczepionka przeciw<br />

wirusowemu zapaleniu<br />

stawów i pochewek<br />

s´cie˛gnowych dla<br />

kurcza˛t<br />

12835 TAD Salmonella vac E z˙ywa, liofilizowana<br />

szczepionka przeciwko<br />

zakaz˙eniom<br />

wywołanym przez<br />

salmonella enteritidis<br />

12836 TAD Salmonella vac T z˙ywa, liofilizowana<br />

szczepionka przeciwko<br />

zakaz˙eniom<br />

wywołanym przez<br />

salmonella<br />

typhimurium<br />

12837 TAD Thymo vac Z˙ywa szczepionki dla<br />

kur przeciw zakaz´nej<br />

anemii kurcza˛t<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lohmann Animal Health 31/12/08<br />

Lohmann Animal Health 31/12/08<br />

Lohmann Animal Health 31/12/08<br />

Lohmann Animal Health<br />

International<br />

Lohmann Animal Health<br />

International<br />

31/12/08<br />

31/12/08<br />

Lohmann Animal Health 31/12/08<br />

Lohmann Animal Health<br />

International<br />

Lohmann Animal Health<br />

International<br />

Lohmann Animal Health<br />

GmbH & Co. KG<br />

31/12/08<br />

31/12/08<br />

6/06/07<br />

12838 Tadenan 25 Pygeum africanum Capsules 25 mg Laboratoires Debat 30/04/04<br />

12839 Tadenan 50 Pygeum africanum Capsules 50 mg Laboratoires Debat 31/05/04<br />

12845 Tadroxil Cefadroxilum Capsules 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12841 Tadroxil Cefadroxilum Granules for oral<br />

solution<br />

12842 Tadroxil Cefadroxilum Granules for oral<br />

solution<br />

12843 Tadroxil Cefadroxilum Granules for oral<br />

solution<br />

12840 Tadroxil Cefadroxilum Granules for oral<br />

suspension<br />

12844 Tadroxil Cefadroxilum Granules for oral<br />

suspension<br />

12846 Tafen 200 Novolizer Budesonidum Inhalation powder 200 µg/dawke˛<br />

inhalacyjna˛<br />

125 mg/5 ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

250 mg/5 ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

125 mg/2,5g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

500 mg/5 ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

250 mg/2,5 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/06/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Lek Polska Sp. z o.o. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1301<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12847 Tafen Nasal Budesonidum Nasal spray, water<br />

suspension<br />

12848 Tafril A, Sefril A Cefradinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

50 mcg/dawke˛<br />

donosowa˛<br />

Lek Pharmaceuticals d.d. 23/11/05<br />

1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12851 Tafril, Sefril Cefradinum Capsules 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12849 Tafril, Sefril Cefradinum Granules for oral<br />

solution<br />

12850 Tafril, Sefril Cefradinum Granules for oral<br />

solution<br />

250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

250 mg/5ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/04/05<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

12852 Tagren Ticlopidinum Tablets 250 mg Krka d.d., Novo mesto 30/11/04<br />

12853 Takatol Sertalinum Cream 4,17<br />

mikrogramów<br />

12854 Takatol Sertalinum Ointment 4,17<br />

mikrogramów<br />

12855 Taktic 12,5 % Amitrazum Solution for veterinary<br />

use<br />

Instytut Farmaceutyczny 31/12/08<br />

Instytut Farmaceutyczny 31/12/08<br />

Intervet International B.V. 20/12/06<br />

12856 Talcid Hydrotalcitum Buccal tablet 0.5 g Bayer AG 31/12/07<br />

12857 Talcid Hydrotalcitum Suspension 1 g/10 ml Bayer AG 31/12/07<br />

12858 Talcid Mint Hydrotalcitum Chewing gum 500 mg Bayer AG 31/12/08<br />

12859 Taleum Acidum cromoglicicum Pressurised inhalation,<br />

suspension<br />

5 mg/dawke˛ Egis Pharmaceuticals Ltd. 31/01/05<br />

12860 Taliamix Mieszanka ziołowa Instant herbal tea Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

12861 Talion Preparat ziołowy Oral solution Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

31/05/06<br />

31/03/07<br />

12862 Talk A.C.E.F., Włochy 31/12/08<br />

12863 Talk Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/12/08<br />

12864 Talk Avena, Bydgoszcz 31/12/08<br />

12865 Talk Cefarm Gdańsk 31/12/08<br />

12866 Talk Hasco-Lek, Wrocław 31/12/08<br />

12867 Talk Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

31/12/08<br />

12868 Talk Lefarm, Bydgoszcz 31/12/08<br />

12869 Talk Maggie, Warszawa 31/12/08<br />

12870 Talk Pampa, Piaseczno 31/12/08<br />

12871 Talk Pharma Cosmetic, Kraków 31/12/08<br />

12872 Talk PPF GEMI, Karczew 31/12/08<br />

12873 Talk PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/08


EN<br />

1302 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12874 Talk PZF ‘Cefarm-Lublin’ S.A. 31/12/08<br />

12875 Talk Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

12876 Talk Zakład Produkcyjno-<br />

Usługowy Farko s.c., Mrocza<br />

12877 Talovac 104 MG Szczepionka dla<br />

kurcza˛t przeciw<br />

zakaz˙eniom<br />

Mycoplasma<br />

gallisepticum<br />

12878 Talovac 107 EDS Szczepionka przeciw<br />

syndromowi spadku<br />

nies´nos´ci dla kur<br />

12879 Talovac 401 ND/IB/IBD/REO Szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu oskrzeli,<br />

rzekomemu pomorowi<br />

drobiu, chorobie<br />

Gumboro oraz<br />

zakaz˙eniom<br />

reowirusowym<br />

12880 Talovac ND/IBD/EDS Szczepionka przeciw<br />

rzekomemu pomorowi<br />

drobiu, zakaz´nemu<br />

zapaleniu torby<br />

Fabrycjusza,<br />

syndromowi spadku<br />

nies´nos´ci<br />

Emulsion for veterinary<br />

use<br />

Emulsion for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

Lohmann Animal Health 4/01/04<br />

Lohmann Animal Health<br />

GmbH & Co. KG.<br />

28/03/04<br />

Lohmann Animal Health 31/12/08<br />

Lohmann Animal Health 31/12/08<br />

12883 Taloxa Felbamatum Oral suspension 120 mg/ml Schering-Plough Labo N.V. 30/06/07<br />

12881 Taloxa Felbamatum Tablets 400 mg Schering-Plough Labo N.V. 30/06/07<br />

12882 Taloxa Felbamatum Tablets 600 mg Schering-Plough Labo N.V. 30/06/07<br />

12884 Talso Sabalis serrulatae fructus<br />

extractum<br />

12885 Talso Uno Sabalis serrulatae fructus<br />

extractum<br />

Capsules 160 mg Sanofi Winthrop GmbH 31/05/04<br />

Capsules 320 mg Sanofi Winthrop GmbH 31/05/04<br />

12886 Talusin 0,25 Proscillaridinum Coated tablets 0.25 mg Abbott GmbH & Co KG 30/05/04<br />

12887 Talvosilen Codeinum +<br />

Paracetamolum<br />

12888 Talvosilen Codeinum +<br />

Paracetamolum<br />

12890 Talvosilen forte Codeinum +<br />

Paracetamolum<br />

12889 Talvosilen forte Codeinum +<br />

Paracetamolum<br />

Syrup (5mg +<br />

200mg) / 5ml<br />

Tablets 20mg +<br />

500mg<br />

Capsules 30mg +<br />

500mg<br />

Suppository 60mg +<br />

1000mg<br />

Bene Arzneimittel GmbH 17/02/05<br />

Bene Arzneimittel GmbH 31/12/08<br />

Bene Arzneimittel GmbH 31/12/08<br />

Bene Arzneimittel GmbH 30/06/04<br />

12891 Tambocor Flecainidum Tablets 50 mg 3 M MEDICA 31/12/08<br />

12892 Tambocor Flecainidum Tablets 100 mg 3 M MEDICA 31/12/08<br />

12893 Tamiflu Oseltamivirum Capsules, hard 75 mg F. Hoffmann — La Roche<br />

Ltd.<br />

12894 Tamiflu Oseltamivirum Powder for oral<br />

suspension<br />

12 mg/ml F. Hoffmann — La Roche<br />

Ltd.<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1303<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12895 Tamofen Tamoxifenum Tablets 10 mg Leiras Oy 31/07/04<br />

12896 Tamofen Tamoxifenum Tablets 20 mg Leiras Oy 31/07/04<br />

12897 Tamofen Tamoxifenum Tablets 40 mg Leiras Oy 31/07/04<br />

12898 Tamosin Tamsolusinum Capsules 0,4 mg GENEXO Sp.z.o.o Warszawa 31/12/08<br />

12899 Tamox Amoxicillunum Tablet for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

6/10/05<br />

12902 Tamoxifen Tamoxifenum Film-coated tablets 10 mg Norton Healthcare Ltd. 30/06/04<br />

12900 Tamoxifen Tamoxifenum Tablets 10 mg VIPHARM S.A. 31/12/05<br />

12901 Tamoxifen Tamoxifenum Tablets 20 mg VIPHARM S.A. 31/12/07<br />

12903 Tamoxifen Tamoxiofenum Tablets 10 mg i 20 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/07<br />

12904 Tamoxifen 10 Hexal Tamoxifenum Film-coated tablets 10 mg Hexal AG 31/01/05<br />

12905 Tamoxifen 20 Hexal Tamoxifenum Film-coated tablets 20 mg Hexal AG 31/01/05<br />

12906 Tamoxifen 30 Hexal Tamoxifenum Film-coated tablets 30 mg Hexal AG 31/01/05<br />

12907 Tamoxifen, Zitazonium Tamoxifenum Tablets 10 mg Egis Pharmaceuticals Ltd. 30/06/04<br />

12908 Tamoxifen, Zitazonium Tamoxifenum Tablets 20 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

12909 Tamoxifen, Zitazonium Tamoxifenum Tablets 30 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

12910 Tamoxifen, Zitazonium Tamoxifenum Tablets 40 mg Egis Pharmaceuticals Ltd. 31/12/08<br />

12911 Tamoxifen-Ebewe, Tamoxifen-<br />

Knoll 10<br />

12912 Tamoxifen-Ebewe, Tamoxifen-<br />

Knoll 20<br />

12913 Tamoxifen-Ebewe, Tamoxifen-<br />

Knoll 30<br />

Tamoxifenum Tablets 10 mg EBEWE Arzneimittel GmbH 31/12/07<br />

Tamoxifenum Tablets 20 mg EBEWE Arzneimittel GmbH 31/12/07<br />

Tamoxifenum Tablets 30 mg EBEWE Arzneimittel GmbH 31/12/07<br />

12914 Tamsinal Sr Tamsolusinum Prolonged release<br />

capsules<br />

0,4 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

12915 Tamsolusin Tamsolusinum Tablets PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

12916 Tamsulosin Hydrochloride Tamsolusinum Prolonged release<br />

capsules<br />

12917 Tamsulozyna Tamsolusinum Prolonged release<br />

capsules<br />

0,4 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

0,4 mg POL-NIL Sp. z.o.o. 31/12/08<br />

12918 Tanacet-Heel Drops Heel GmbH 31/12/08<br />

12920 Tanakan Ginkgo biloba Film-coated tablets 40 mg Beaufour Ipsen Pharma 30/04/04<br />

12919 Tanakan Ginkgo biloba Oral solution 40 mg/ml Beaufour Ipsen Pharma 30/04/04<br />

12921 Tanatril Imidaprilum Tablets 5 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

12922 Tanatril Imidaprilum Tablets 10 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

12923 Tanatril Imidaprilum Tablets 20 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

1304 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12924 Tanina Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

31/03/06<br />

12925 Tanina Pharma Cosmetic, Kraków 31/03/06<br />

12926 Tanina Pharma Zentrale 31/03/06<br />

12927 Tanina PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

12928 Taniny bia czan Margo Corporation,<br />

Warszawa<br />

12929 Tanninum albuminatum Tablets 0.5 g Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

31/03/06<br />

31/12/08<br />

30/10/05<br />

12930 Tannosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

12931 Tanoxal Paste for oral<br />

suspension<br />

12932 Tantum Benzydamini<br />

hydrochloridum<br />

12933 Tantum Benzydamini<br />

hydrochloridum<br />

12934 Tantum Rosa Benzydamini<br />

hydrochloridum<br />

Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’,<br />

Pruszków<br />

Cream 50 mg/g Aziende Chimiche Riunite<br />

Angelini Francesco<br />

Gel 50 mg/g Aziende Chimiche Riunite<br />

Angelini Francesco<br />

Powder for solution<br />

for irrigation<br />

53,2 mg/g Aziende Chimiche Riunite<br />

Angelini Francesco<br />

12935 Tantum Verde Benzydamidum Oromucosal solution 1,5 mg/ml CSC Pharmaceuticals Handels<br />

GmbH<br />

12937 Tantum Verde Benzydamini<br />

hydrochloridum<br />

12936 Tantum Verde Benzydamini<br />

hydrochloridum<br />

12938 Tantum Verde P Benzydamini<br />

hydrochloridum<br />

Mouth and gargle<br />

wash solution<br />

Oromucosal and<br />

gargle spray<br />

1,5 mg/ml Aziende Chimiche Riunite<br />

Angelini Francesco<br />

1,5 mg/ml Aziende Chimiche Riunite<br />

Angelini Francesco<br />

Lozenge 3 mg Aziende Chimiche Riunite<br />

Angelini Francesco<br />

12939 Tantum® Verde Benzydamidum Medicated toothpaste 5 mg/g CSC Pharmaceuticals Handels<br />

GmbH<br />

12940 Tao tao Ginseng radix extractum Granules for oral<br />

solution<br />

300 mg TAN-VIET International Ltd.,<br />

Gdańsk<br />

31/12/08<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

31/08/04<br />

31/12/08<br />

31/12/08<br />

12943 Taracef Cefaclorum Capsules 250 mg Krka d.d., Novo mesto 14/02/06<br />

12944 Taracef Cefaclorum Capsules 500 mg Krka d.d., Novo mesto 14/02/06<br />

12941 Taracef Cefaclorum Granules for oral<br />

solution<br />

12942 Taracef Cefaclorum Granules for oral<br />

solution<br />

12945 Tarcefandol Cefamandolum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

12946 Tarcefandol Cefamandolum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

12947 Tarcefoksym Cefotaximum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

125 mg/5 ml KRKA d.d., Novo mesto 31/12/08<br />

250 mg/5 ml KRKA d.d., Novo mesto 31/12/08<br />

1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/07/05<br />

31/07/05<br />

30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1305<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12948 Tarcefoksym Cefotaximum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12949 Tarcevis Cefetametum Film-coated tablets 250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12950 Tarcevis Cefetametum Film-coated tablets 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12951 Tarchocillin Forte Penicylina G potasowa,<br />

Penicylina G<br />

prokainowa,<br />

Streptomycyna<br />

12952 Tarchomiocin Benzathini<br />

benzaylpenicillinum +<br />

Benzylpenicillinum<br />

procainicum +<br />

Dihydrostreptomycinum<br />

Dry substance for<br />

suspension for<br />

injection<br />

12953 Tardyferon Ferrosi sulfas Prolonged release<br />

tablets<br />

12954 Tardyferon-Fol Acidum folicum +<br />

Ferrosi sulfas<br />

for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Film-coated, modified<br />

release tablets<br />

12955 Tarfazolin Cefazolinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

12956 Tarfazolin Cefazolinum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and infusion<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne ‘Polfa’<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne Polfa<br />

14/09/05<br />

5/04/05<br />

5/04/05<br />

31/12/08<br />

10/05/04<br />

80 mg Fe++ Robapharm AG 30/01/05<br />

Robapharm AG 15/05/06<br />

1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12957 Tarfenac Diclofenacum Gel 1 % Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12958 Targocid Teicoplaninum Lyophiliste and<br />

solvent for solution<br />

for intravenous or<br />

intramuscular<br />

injection or<br />

intravenous infusion<br />

12959 Targocid Teicoplaninum Lyophiliste and<br />

solvent for solution<br />

for intravenous or<br />

intramuscular<br />

injection or<br />

intravenous infusion<br />

12960 Tarivid Ofloxacinum Solution for<br />

intravenous infusion<br />

12/10/05<br />

12/10/05<br />

31/12/08<br />

200 mg Marion Merrell Ltd. 31/01/05<br />

400 mg Marion Merrell Ltd. 31/01/05<br />

2 mg/ml Hoechst Marion Roussel<br />

Deutschland GmbH<br />

12961 Tarivid 200 Ofloxacinum Film-coated tablets 200 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

12962 Tarka Trandolaprilum +<br />

Verapamilum<br />

Prolonged release<br />

capsules<br />

30/04/04<br />

30/04/04<br />

2mg + 180mg Abbott GmbH & Co KG 31/12/08<br />

12964 Taromeg Megestrolum Oral suspension 40 mg/ml Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12963 Taromeg Megestrolum Tablets 160 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12967 Taromentin Acidum clavulanicum +<br />

Amoxicillinum<br />

Film-coated tablets 125mg +<br />

250mg<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

28/02/06


EN<br />

1306 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12968 Taromentin Acidum clavulanicum +<br />

Amoxicillinum<br />

12965 Taromentin Acidum clavulanicum +<br />

Amoxicillinum<br />

12966 Taromentin Acidum clavulanicum +<br />

Amoxicillinum<br />

12972 Taromentin Amoxicillinum +<br />

Acidum clavulanicum<br />

12969 Taromentin Amoxicillinum +<br />

Acidum clavulanicum<br />

12970 Taromentin Amoxicillinum +<br />

Acidum clavulanicum<br />

12971 Taromentin Amoxicillinum +<br />

Acidum clavulanicum<br />

12973 Taropen Benzathini<br />

phenoxymethylpenicillinum<br />

12974 Taropen Benzathini<br />

phenoxymethylpenicillinum<br />

12975 Taropen Benzathini<br />

phenoxymethylpenicillinum<br />

12976 Taropen Benzathini<br />

phenoxymethylpenicillinum<br />

12977 Taropen Phenoxymethylpenicillinum<br />

12978 Taropen Phenoxymethylpenicillinum<br />

12979 Taropen Phenoxymethylpenicillinum<br />

Film-coated tablets 125mg +<br />

500mg<br />

Powder for solution<br />

for intravascular<br />

injection and infusion<br />

Powder for solution<br />

for intravascular<br />

injection and infusion<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

200mg + 1g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

100mg +<br />

500mg<br />

Film-coated tablets 875 mg + 125)<br />

mg<br />

Powder for oral<br />

suspension<br />

Powder for oral<br />

suspension<br />

Powder for oral<br />

suspension<br />

(125 + 31,25)<br />

mg / 5 ml<br />

(250 + 62,5)<br />

mg / 5 ml<br />

(400 + 57) mg<br />

/ 5 ml<br />

Oral suspension 400 000 j.m./<br />

5ml<br />

Oral suspension 750 000 j.m./<br />

5ml<br />

Oral suspension 400 000 j.m./<br />

5ml<br />

Oral suspension 750 000 j.m./<br />

5ml<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakła˛dy<br />

Farmaceutyczne POLFA S.A.<br />

Tarchomińskie Zakła˛dy<br />

Farmaceutyczne POLFA S.A.<br />

Film-coated tablets 1500000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Film-coated tablets 1000000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Film-coated tablets 500000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

12983 Tarproxen Naproxenum Gel 100 mg / g<br />

(10 %)<br />

12980 Tarproxen Naproxenum Granules for oral<br />

solution<br />

12981 Tarproxen Naproxenum Granules for oral<br />

solution<br />

12982 Tarproxen Naproxenum Granules for oral<br />

solution<br />

12984 Tarsime Cefuroximum Powder for solution<br />

for intravascular<br />

injection and infusion<br />

12985 Tarsime Cefuroximum Powder for<br />

suspension for<br />

intramuscular<br />

injection and solution<br />

for inravenous<br />

injection<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

125 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

1.5 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

750 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

28/02/06<br />

30/04/06<br />

30/04/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

29/08/07<br />

29/08/07<br />

29/08/07<br />

29/08/07<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

21/06/06<br />

21/06/06<br />

21/06/06<br />

31/05/06<br />

31/05/06<br />

12986 Tartephedreel N Drops Heel GmbH 31/12/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1307<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

12987 Tartriakson Ceftriaxonum Dry substance for<br />

injection<br />

12988 Tartriakson Ceftriaxonum Dry substance for<br />

injection<br />

1 g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

12989 Tauredon 10 Natrii aurothiomaleas Solution for injection 10 mg/0,5 ml Altana Pharma AG 30/06/04<br />

12990 Tauredon 20 Natrii aurothiomaleas Solution for injection 20 mg/0,5 ml Altana Pharma AG 30/06/04<br />

12991 Tavanic Levofloxacinum Solution for infusion 5 mg/ml Hoechst Marion Roussel<br />

Deutschland GmbH<br />

12992 Tavanic 250 Levofloxacinum Film-coated tablets 250 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

12993 Tavanic 500 Levofloxacinum Film-coated tablets 500 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

12994 Tavor Expidet Lorazepamum Tablets 1 mg Wyeth — Lederle Pharma<br />

GmbH<br />

12995 Tavor Expidet Lorazepamum Tablets 2,5 mg Wyeth — Lederle Pharma<br />

GmbH<br />

26/04/06<br />

26/04/06<br />

26/04/06<br />

31/12/08<br />

31/12/08<br />

12996 Taxilan Perazinum Solution for injection 25 mg/ml Altana Pharma AG 30/06/04<br />

12997 Taxol Paclitaxelum Solution for injection 6 mg/ml Bristol-Myers Squibb S.p.A,<br />

Latina<br />

12998 Taxotere Docetaxelum Concentrate and<br />

solvent for solution<br />

for intravenous<br />

infusion<br />

31/12/06<br />

40 mg/ml Aventis Pharma S.A. 17/09/06<br />

12999 Tazamol Paracetamolum Tablets 325 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

13000 Tazamol Paracetamolum Tablets 500 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

13001 Tazocin Piperacillinum +<br />

Tazobactamum<br />

13002 Tazocin Piperacillinum +<br />

Tazobactamum<br />

Lyophilisate for<br />

solution for<br />

intravenous injection<br />

Lyophilisate for<br />

solution for<br />

intravenous injection<br />

13003 TCK-5 Albuminum Lyophilisate for<br />

suspension for<br />

intravenous injection<br />

13004 Td-pur Diphtheriae-tetanus Suspension for<br />

intramuscular<br />

injection<br />

13005 Td-Szczepionka te˛z˙cowobłonicza<br />

adsorbowana<br />

Diphtheria toxoid+<br />

tetanus toxoid<br />

13006 Tears Naturale Dextranum +<br />

Hypromellosum<br />

Suspension for<br />

subcutaneous<br />

injection<br />

31/03/07<br />

31/03/07<br />

2g + 250mg Wyeth-Lederle Pharma GmbH 17/10/05<br />

4g + 500mg Wyeth-Lederle Pharma GmbH 17/10/05<br />

Cis bio international B.P. 31/01/05<br />

1 dawka Chiron Behring GmbH & Co. 12/10/05<br />

nie mniej niz˙<br />

40 j.m.<br />

toksoidu<br />

te˛z˙cowego i<br />

nie mniej niz˙<br />

5 j.m. toksoidu<br />

błoniczego<br />

(1 dawka —<br />

0,5ml)<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

31/08/05<br />

Eye drops Alcon Couvreur N.V. 30/06/04<br />

13007 Tears Naturale Free Eye drops, solution Alcon Laboratoires Inc Texas 30/04/04


EN<br />

1308 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13008 Tears Naturale II Dextranum +<br />

Hypromellosum<br />

13009 Tecelac Antilymphocyte<br />

immunoglobulin (horse)<br />

13010 Technescan DMSA Preparat<br />

radiofarmaceutyczny<br />

13011 Technescan DTPA Preparat<br />

radiofarmaceutyczny<br />

13012 Technescan DTPA Preparat<br />

radiofarmaceutyczny<br />

13013 Technescan HDP Preparat<br />

radiofarmaceutyczny<br />

13014 Technescan HIG Preparat<br />

radiofarmaceutyczny<br />

13015 Technescan Lyomaa Preparat<br />

radiofarmaceutyczny<br />

13016 Technescan PYP Preparat<br />

radiofarmaceutyczny<br />

Eye drops Alcon Couvreur N.V. 14/03/07<br />

Concantrate for<br />

solution for<br />

intravenous infusion<br />

13017 Tectonic Pour On Permetryna Solution for veterinary<br />

use<br />

100 mg/5 ml Biotest Pharma GmbH 27/06/07<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Virbac 31/12/08<br />

13018 Tegretol Carbamazepinum Syrup 20 mg/ml Novartis Pharma AG 31/03/05<br />

13019 Tegretol CR 200 Carbamazepinum Modified release<br />

tablets<br />

13020 Tegretol CR 400 Carbamazepinum Modified release<br />

tablets<br />

200 mg Novartis Pharma AG 31/05/04<br />

400 mg Novartis Pharma AG 31/05/04<br />

13021 Telfast 120 Fexofenadinum Film-coated tablets 120 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

13022 Telfast 180 Fexofenadinum Film-coated tablets 180 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

13023 Telmin KH Mebendazol Tablet for veterinary<br />

use<br />

13024 Telmin Paste Mebendazol Paste for veterinary<br />

use<br />

13025 Telmin+Trichlorfon Mebendazol,<br />

Metrifonat<br />

13026 Temar Tamsolusinum Prolonged release<br />

capsules<br />

Paste for veterinary<br />

use<br />

31/07/04<br />

31/07/04<br />

Janssen 30/06/04<br />

Janssen Pharmaceutica 26/01/06<br />

Janssen-Cilag 19/01/04<br />

0,4 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

13027 Temgesic Buprenorphinum Sublingual tablets 0.2 mg Reckitt&Colman Products<br />

Limited<br />

13028 Temodal Temozolomidum Capsuels, hard 100 mg Schering-Plough Central East<br />

AG<br />

13029 Temodal Temozolomidum Capsuels, hard 20 mg Schering-Plough Central East<br />

AG<br />

13030 Temodal Temozolomidum Capsuels, hard 250 mg Schering-Plough Central East<br />

AG<br />

13031 Temodal Temozolomidum Capsuels, hard 5 mg Schering-Plough Central East<br />

AG<br />

31/12/08<br />

30/06/04<br />

31/07/05<br />

31/07/05<br />

31/07/05<br />

31/07/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1309<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13032 Tenasil Terbinafinum Cream 10 mg/g Homeofarm Sp. z o.o.<br />

Laboratorium<br />

Farmaceutyczne<br />

13033 Tenaver Niklozamid,<br />

Lewamizolu<br />

chlorowodorek<br />

Tablet for veterinary<br />

use<br />

Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

6/12/06<br />

31/12/07<br />

13034 Tenaxum Rilmenidinum Tablets 1 mg Les Laboratoires Servier 31/12/07<br />

13035 Tenazym chlorowodorek<br />

tetracykliny, siarczan<br />

neomycyny, octan<br />

prednizolonu,<br />

chymotropsa,<br />

trypsyna, papaina<br />

Suspension for veterinary<br />

use<br />

Veyx Pharma 31/12/08<br />

13036 Tendo/Allium Cepa comp. Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

13037 Tendo/Allium Cepa comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

13038 Tendosan Olejek terpentynowy,<br />

Olej rycynowy,<br />

Kamfora, Jod, Jodek<br />

potasu<br />

Liquid for veterinary<br />

use<br />

13039 Tenican Praziquantelum Tablet for veterinary<br />

use<br />

Biowet Puławy 26/04/04<br />

Zakłady Farmaceutyczne<br />

BiowetS.A.<br />

31/12/08<br />

13040 Tenormin Atenololum Film-coated tablets 100 mg AstraZeneca UK Ltd. 30/06/04<br />

13041 Tenox Amlodipinum Tablets 5 mg KRKA Polska Sp. z o.o. 30/09/07<br />

13042 Tenox Amlodipinum Tablets 10 mg KRKA Polska Sp. z o.o. 30/09/07<br />

13043 Tensin Perindoprilum Tablets 4 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

13044 Tensin Plus Perindoprilum +<br />

Indapamidum<br />

Tablets 2 mg +<br />

0,625 mg<br />

Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

13045 Teobromina Margo Corporation,<br />

Warszawa<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

13046 Teobromina Pharma Cosmetic, Kraków 31/12/08<br />

13047 Teobromina Pharma Zentrale 31/12/08<br />

13048 Teobromina PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

13049 Teobrominian sodowy z<br />

sodowym salicylanem<br />

13050 Teofilina Margo Corporation,<br />

Warszawa<br />

31/12/08<br />

Pharma Zentrale 14/01/05<br />

13051 Teofilina PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

13052 Teofilina Jelfa Theophyllinum Solution for injection Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

13053 Teotard 200 Theophyllinum Prolonged release<br />

capsules<br />

13054 Teotard 350 Theophyllinum Prolonged release<br />

capsules<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

200 mg Krka d.d., Novo mesto 31/07/04<br />

350 mg Krka d.d., Novo mesto 31/07/04<br />

13055 Tepasta Preparat złoz˙ony Paste Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

30/10/05


EN<br />

1310 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13056 Terbinafin Terbinafinum Tablets 125 mg i<br />

250 mg<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

13057 Terbinafina Terbinafinum Cream 1 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

13058 Terbinafina Terbinafinum Gel 1 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

13059 Terbisil Terbinafinum Cream 1 % Chemical Works of Gedeon<br />

Richter Ltd.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

13060 Terbisil Terbinafinum Tablets 250 mg Gedeon Richter Ltd. 27/06/07<br />

13061 Terbisil Kid Terbinafinum Tablets 125 mg Gedeon Richter Ltd. 27/06/07<br />

13062 Terbutalin Stada Retard Terbutalinum Capsules 7.5 mg Stada Arzneimittel AG 31/01/05<br />

13063 Termasil Preparat ziołowy Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

13064 Terpamid Sr Indapamidum Modified release<br />

tablets<br />

1,5 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

13065 Terpichol Capsules Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

13066 Terramycin LA Oxytetracyclinum Solution for veterinary<br />

use<br />

13067 Terrexine Cefaleksyna,<br />

Kanamycyny siarczan<br />

13068 Tertensif SR Indapamidum Film-coated, slow<br />

release tablets<br />

Suspension for veterinary<br />

use<br />

13069 Teslascan Mangafodipirum Solution for<br />

intravenous infusion<br />

13070 Testarpen Lyophilisate for<br />

solution for injection<br />

30/10/05<br />

31/12/08<br />

30/10/05<br />

Pfizer 31/12/08<br />

Univet 3/08/04<br />

1.5 mg Les Laboratoires Servier 31/12/07<br />

0.01 mmol/ml Nycomed Imaging AS 12/10/05<br />

1× 10 -7 reszt<br />

penicyloilowych<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/04/05<br />

13071 TESTES comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

13072 TESTES comp. gran. WALA-Heilmittel GmbH 19/03/05<br />

13073 Testis Compositum Amp. Heel GmbH 31/12/08<br />

13074 Testo -Z˙el Terstosteronum Gel 1 % Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

13075 Testosteronum prolongatum Testosteronum Solution for injection 100 mg/ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

13076 Testosteronum propionicum Testosteronum Solution for injection 25 mg/1 ml Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

13077 Tetabulin Tetanus immunoglobulin Solution for<br />

intramuscular<br />

injection<br />

31/12/08<br />

30/11/05<br />

30/11/05<br />

250 j.m. Baxter AG 30/04/04<br />

13078 Tetaglobuline Tetanus immunoglobulin Solution for injection 250 j.m. Aventis Pasteur S.A. 30/04/04<br />

13079 Tetagripiffa Szczepionka przeciw<br />

grypie i te˛z˙cowi koni<br />

13080 Tetanin Surowica<br />

przeciwte˛z˙cowa<br />

Suspension for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Merial 14/06/04<br />

Drwalewskie Zakłady Przem.<br />

Bioweterynaryjnego<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1311<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13081 Tetanus Toxoid Szczepionka dla koni<br />

przeciwko te˛z˙cowi<br />

13082 Tetanusan 24 % Glukonian wapnia ,<br />

Kwas borowy, Chlorek<br />

magnezu, Chlorek<br />

manganu, Glukonian<br />

kobaltu,<br />

Glicerofosforan<br />

disodowy<br />

13083 Tetanusan 50 % Glukonian wapnia,<br />

Kwas borowy, Chlorek<br />

magnezu, Chlorek<br />

manganu , Glukonian<br />

kobaltu,<br />

Glicerofosforan<br />

disodowy,<br />

Glicerofosforan z˙elaza<br />

13084 Tetesept Angidin Acidum ascorbicum (vit<br />

C) + Cetylpyridinium +<br />

Dequalinium<br />

Liquid for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Fort Dodge 31/12/08<br />

Atarost 31/12/08<br />

Atarost 13/10/04<br />

Buccal tablet Merz & Co. GmbH 30/04/05<br />

13085 Tetracaini hydrochloridum Margo Corporation,<br />

Warszawa<br />

31/12/08<br />

13086 Tetracainy chlorowodorek Pharma Cosmetic, Kraków 31/12/08<br />

13087 Tetracainy chlorowodorek Pharma Zentrale 31/12/08<br />

13088 Tetracoq Suspension for<br />

intramuscular and<br />

intravenous injection<br />

13089 Tetracoq Suspension for<br />

subcutaneous or<br />

intramuscular<br />

injection<br />

13090 Tetract — HIB Vaccinum diphteriae,<br />

teatni, pertussis et<br />

haemophili stripe b<br />

conjugatum adsorbatum<br />

Powder and solvent<br />

for solution for<br />

intramuscular<br />

injection<br />

20 dawek Aventis Pasteur S.A. 31/12/08<br />

1 dawka Aventis Pasteur S.A. 31/12/08<br />

szCZpionka 1<br />

— dawkowa<br />

Aventis Pasteur S.A. 31/12/08<br />

13091 Tetracyclinum Tetracyclinum Film-coated tablets 250 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

13092 Tetracyclinum 3 % Tetracyclinum Ointment 30 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

13093 Tetradog Szczepionka<br />

przeciwko nosówce,<br />

zakaz˙eniom<br />

adenowirusowym,<br />

parwowirozie,<br />

leptospirozie psów<br />

Lyophilisate + liquid for veterinary<br />

use<br />

30/04/05<br />

31/01/06<br />

Merial 3/09/04<br />

13094 Tetradox Doxycyclinum Capsules 100 mg Ranbaxy Laboratoires Ltd. 29/08/07<br />

13095 Tetradur LA 300 Oxytetracyclinum Solution for veterinary<br />

use<br />

Merial 31/12/08<br />

13096 Tetrakainy chlorowodorek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

24/07/06<br />

13097 Tetralysal Lymecyclinum Capsules 150 mg Laboratoires Galderma 19/09/07<br />

13098 Tetramutin CTC Premix Chlortetracyklina,<br />

tiamulin<br />

Premix for veterinary<br />

use<br />

Novartis 31/12/08


EN<br />

1312 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13099 Tetramutin OT Oksytetracykliny<br />

chlorowodorek,<br />

Tiamuliny<br />

wodorofumaran<br />

Powder for veterinary<br />

use<br />

Novartis Animal Health Inc. 31/12/07<br />

13100 Tetraratio Tetrazepamum Film-coated tablets 50 mg ratiopharm GmbH 29/11/06<br />

13101 Tetraseptin 100 mg Tetracyklina Suspension for veterinary<br />

use<br />

13102 Tetraseptin 200 mg Tetracyklina Suspension for veterinary<br />

use<br />

13103 Tetravet L.A. Oxytetracyclinum Solution for veterinary<br />

use<br />

Vetoquinol S.A. 3/11/05<br />

Vetoquinol S.A. 3/11/05<br />

Ceva Sante Animale 8/09/05<br />

13104 Tetrazepam Tetrazepamum Film-coated tablets 50 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

13105 Tetrazepam 50 Jelfa Tetrazepamum Film-coated tablets 50 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

13106 Tetrox Oxytetracyclinum Granules for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

31/12/08<br />

31/12/08<br />

16/01/05<br />

13107 Teveten Eprosartanum Film-coated tablets 400 mg Solvay Pharmaceuticals B.V. 8/02/06<br />

13108 Teveten Eprosartanum Film-coated tablets 600 mg Solvay Pharmaceuticals B.V. 8/02/06<br />

13109 TFX Thymostimulinum Lyophilisate and<br />

solvent for solution<br />

for subcutaneous and<br />

intramuscular<br />

injection<br />

10 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/04/05<br />

13110 Thalamus compositum Amp. Heel GmbH 31/12/08<br />

13111 Thallous (201ti) Chloride<br />

Injection<br />

Preparat<br />

radiofarmaceutyczny<br />

13112 Theo-Caps, Theophyllinum Theophyllinum Prolonged release<br />

capsules<br />

13113 Theo-Caps, Theophyllinum Theophyllinum Prolonged release<br />

capsules<br />

13114 Theo-Caps, Theophyllinum Theophyllinum Prolonged release<br />

capsules<br />

13115 Theo-Dur Theophyllinum Prolonged release<br />

tablets<br />

13116 Theopaverin Papaverinum +<br />

Theobrominum<br />

Tablets 40mg +<br />

300mg<br />

13117 Theophyllinum Theophyllinum Solution for<br />

intravenous infusion<br />

13118 Theophyllinum prolongatum Theophyllinum Film-coated, prologed<br />

release tablets<br />

13119 Theoplus Theophyllinum Prolonged release<br />

tablets<br />

13120 Theoplus Theophyllinum Prolonged release<br />

tablets<br />

13121 Theospirex Theophylinum Solution for<br />

intravenous injection<br />

and infusion<br />

Mallinckrodt Medical B.V. 31/12/08<br />

100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

200 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

300 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

200 mg AstraZeneca AB 30/06/04<br />

Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/05<br />

1.2 mg/ml Baxter Terpol Sp. z o.o. 30/04/05<br />

250 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/10/05<br />

100 mg Pierre Fabre Medicament 30/06/04<br />

300 mg Pierre Fabre Medicament 30/06/04<br />

20 mg/ml Gebro Pharma GmbH 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1313<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13122 Theospirex retard Theophyllinum Film-coated, slow<br />

release tablets<br />

13123 Theospirex retard 300mg Theophyllinum Prolonged release<br />

tablets<br />

13124 Theovent 100 Theophylinum Prolonged release<br />

capsules<br />

150 mg P.P.H.U. Biofarm Sp. z o.o. 31/12/08<br />

300 mg P.P.H.U. Biofarm Sp. z o.o. 31/01/06<br />

100 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

13125 Theovent 100, Theophyllinum Theophyllinum Suppository 100 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

13126 Theovent 100, Theophyllinum Theophyllinum Tablets 100 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

13127 Theovent 200 Theophylinum Prolonged release<br />

capsules<br />

13128 Theovent 300, Theophyllinum<br />

300<br />

Theophyllinum Prolonged release<br />

tablets<br />

200 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

300 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

13129 Theovent 350, Theophyllinum Theophyllinum Suppository 350 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

13130 Theovent 50 Theophylinum Prolonged release<br />

capsules<br />

13131 Theracalcium Wapnia<br />

glukoheptonian,<br />

Wapnia glukonian<br />

Solution for veterinary<br />

use<br />

13132 Theracap Ù 131 Natrii iodidum (131I) Capsules 37 do<br />

2035 MBq<br />

13133 Thermo-Rheumon Benzyli nicotinas +<br />

Etofenamatum<br />

Cream (100mg +<br />

10mg)/g<br />

50 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/12/08<br />

15/07/06<br />

31/01/05<br />

31/12/08<br />

31/12/05<br />

29/05/05<br />

31/12/08<br />

Vetoquinol S.A. 29/06/06<br />

Nycomed Amersham plc 21/06/06<br />

Bayer AG 31/12/07<br />

13134 Thevalin Propentoffylinum Film-coated tablets 100 mg Slovakofarma a.s. 31/12/08<br />

13135 Thiamphenicol 10 % Tiamfenikol Solution for veterinary<br />

use<br />

13136 Thiocodin Codeinum +<br />

Guaiacolsulfonatum<br />

13137 Thiogamma 600 Acidum lipoicum Concantrate for<br />

solution for<br />

intravenous infusion<br />

Vetos-Farma 31/12/08<br />

Tablets Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

600 mg/20 ml Wörwag Pharma GmbH<br />

Co.KG<br />

13138 Thiogamma 600 Acidum lipoicum Film-coated tablets 600 mg Wörwag Pharma GmbH<br />

Co.KG<br />

31/01/06<br />

17/01/07<br />

17/01/07<br />

13139 Thiomersal Caesar & Loretz GmbH Caelo 31/12/08<br />

13140 Thiopental Thiopentalum Powder for solution<br />

for injection<br />

13141 Thiopental Thiopentalum Powder for solution<br />

for injection<br />

0.5 g Biochemie GmbH — Kundl 30/04/04<br />

1 g Biochemie GmbH — Kundl 30/04/04<br />

13142 Thioridazin Thioridazinum Coated tablets 10 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

13143 Thioridazin Thioridazinum Coated tablets 100 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

13144 Thioridazin Thioridazinum Coated tablets 25 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

13145 Thioridazin prolongatum Thioridazinum Prolonged release<br />

tablets<br />

200 mg Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/11/05


EN<br />

1314 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13146 Thrombate III Antithrombinum III Intravenous injection<br />

(lyophilisate)<br />

13147 Thrombo ASS Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

13148 Thrombo ASS Acidum acetylsalicylicum Film-coated,<br />

gastro-resistant tablets<br />

1000 j.m. Bayer Corporation 31/12/08<br />

0.1 g Lannacher Heilmittel GmbH 31/12/08<br />

50 mg Lannacher Heilmittel GmbH 31/12/08<br />

13149 Thromboreductin Anagrelidum Capsules 0,5 mg Orphan Pharmaceutic AG 31/12/08<br />

13150 Thymazen Tymazolinum Nasal drops, solution 0.5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

13151 Thymi Syrup Lek Pharmaceutical &<br />

Chemical Company d.d.<br />

13152 Thymoglobuline 5 mg/ml Antilymphocyte<br />

immunoglobulin<br />

(królicza)<br />

Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

infusion<br />

13153 Thymovar Thymolum Plate for veterinary<br />

use<br />

13154 Thyrax Duotab Levothyroxinum<br />

natricum<br />

13155 Thyrax Duotab Levothyroxinum<br />

natricum<br />

13156 Thyrax Duotab Levothyroxinum<br />

natricum<br />

31/12/05<br />

31/12/08<br />

25 mg IMTIX SANGSTAT, Lyon 30/04/04<br />

Andermatt Biocontrol AG 31/12/08<br />

Tablets 100 mcg Organon N.V. 30/06/07<br />

Tablets 150 mcg Organon N.V. 30/06/07<br />

Tablets 25 mcg Organon N.V. 30/06/07<br />

13157 Thyreoidea compositum Amp. Heel GmbH 31/12/08<br />

13158 Thyreoidea/Ferrum Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

13159 Thyreoidea/Ferrum Granules WALA-Heilmittel GmbH 24/05/07<br />

13160 Thyreo-Pasc tabletki Pascoe Pharmaceutische<br />

Preparate GmbH<br />

13161 Thyrogen Thyrotropinum alfa Powder for solution<br />

for injection<br />

30/11/05<br />

0,9 mg Genzyme Europe B.V. 31/12/08<br />

13162 Thyrosan Propylthiouracilum Tablets 50 mg Sun Farm Sp. z o.o. 31/01/05<br />

13163 Thyrozol 10 Thiamazolum Film-coated tablets 10 mg Merck KGaA 31/08/04<br />

13164 Thyrozol 20 Thiamazolum Film-coated tablets 20 mg Merck KGaA 31/08/04<br />

13165 Thyrozol 5 Thiamazolum Film-coated tablets 5 mg Merck KGaA 31/08/04<br />

13166 Tiacil Gentamycyny siarczan,<br />

Deksametazonu<br />

fosforan sodowy<br />

Eye drops for veterinary<br />

use<br />

Virbac 24/08/04<br />

13167 Tiadil Terazosinum Tablets 5 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

13168 Tiadil Terazosinum Tablets 2 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

13169 Tiadil Terazosinum Tablets 1 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

13170 Tiadil Terazosinum Tablets (1 mg + 2 mg<br />

+ 5 mg)<br />

Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

13171 Tiadil Terazosinum Tablets (1 mg + 2 mg) Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1315<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13172 Tialorid Amiloridum +<br />

Hydrochlorothiazidum<br />

13173 Tialorid mite Amiloridum +<br />

Hydrochlorothiazidum<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

Tablets Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

13174 Tiamfenikol 25 % Tiamfenikol Solution for veterinary<br />

use<br />

13175 Tiamowet 200 Tiamulina Liquid for veterinary<br />

use<br />

13176 Tiamowet 45 % granulat Tiamuliny<br />

wodorofumaran<br />

13177 Tiamulinum 10 % +<br />

Oxytetracyclinum 30 %<br />

13178 Tiamulinum 2,5 % +<br />

Oxytetracyclinum 8 %<br />

Tiamuliny<br />

wodorofumaran,<br />

Oksytetracykliny<br />

chlorowodorek<br />

Tiamuliny<br />

wodorofumaran,<br />

Oksytetracykliny<br />

chlorowodorek<br />

13179 Tiamulinum 45 % Tiamuliny<br />

wodorofumaran<br />

13180 Tiamulinum Premix 10 % Tiamuliny<br />

wodorofumaran<br />

13181 Tiamulinum Premix 2 % Tiamuliny<br />

wodorofumaran<br />

13182 Tiamutin 10 % Premiks Tiamuliny<br />

wodorofumaran<br />

Granules for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

Premix for veterinary<br />

use<br />

Premix for veterinary<br />

use<br />

Premix for veterinary<br />

use<br />

13183 Tiamutin 10 % Pro.inj. Tiamulina Solution for veterinary<br />

use<br />

13184 Tiamutin 12,5 % roztwór wodorofumaran<br />

tamuliny<br />

13185 Tiamutin 2 % Premiks Tiamuliny<br />

wodorofumaran<br />

13186 Tiamutin 45 % Granulat Tiamuliny<br />

wodorofumaran<br />

Solution for veterinary<br />

use<br />

Premix for veterinary<br />

use<br />

Granules for veterinary<br />

use<br />

31/01/06<br />

6/11/05<br />

Biowet Puławy 31/12/08<br />

Biowet Gorzów 31/12/08<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

31/08/04<br />

Interbiowet Spółka z o.o. 19/12/06<br />

Interbiowet Spółka z o.o. 19/12/06<br />

Interbiowet 17/06/06<br />

Interbiowet 17/06/06<br />

Interbiowet 17/06/06<br />

Novartis Animal Health Inc. 31/12/08<br />

Novartis Animal Health Inc. 31/12/08<br />

Novartis 31/12/08<br />

Novartis Animal Health Inc. 31/12/08<br />

Novartis Animal Health Inc. 31/12/08<br />

13187 Tiapridal Tiapridum Oral drops 138 mg/ml Synthelabo Group.<br />

Laboratoires Synthelabo<br />

13190 Tiapridal Tiapridum Prolonged release<br />

tablets<br />

150 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

23/11/05<br />

23/11/05<br />

13188 Tiapridal Tiapridum Solution for injection 100 mg/2 ml Laboratoires Synthelabo 31/12/08<br />

13189 Tiapridal Tiapridum Tablets 100 mg Synthelabo Group.<br />

Laboratoires Synthelabo<br />

23/11/05<br />

13191 Tibolon Tibolonum Tablets 2,5 mg Instytut Farmaceutyczny 31/12/08<br />

13192 Ticlid Ticlopidinum Film-coated tablets 250 mg Sanofi Winthrop-Gentilly 30/04/04<br />

13193 Ticlipsor Ticlopidinum Film-coated tablets 250 mg IPSOR 31/12/08<br />

13194 Ticlo Ticlopidinum Film-coated tablets 250 mg Schwarz Pharma Sp. z o.o. 31/05/06<br />

13195 Ticlopidine Poli Ticlopidinum Film-coated tablets 250 mg Monsanto Italiana S.p.A. 24/05/06<br />

13196 Ticloratio Ticlopidinum Film-coated tablets 250 mg ratiopharm GmbH 21/03/07


EN<br />

1316 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13197 Ticlosan Ticlopidinum Tablets 250 mg Schwarz Pharma Sp. z o.o. 31/12/08<br />

13199 Tienam Cilastatinum +<br />

Imipenemum<br />

13198 Tienam Cilastatinum +<br />

Imipenemum<br />

Powder for solution<br />

for intramuscular<br />

injections<br />

Powder for solution<br />

for intravenous<br />

injection<br />

500mg +<br />

500mg<br />

500mg +<br />

500mg<br />

Merck Sharp & Dohme Idea<br />

Inc.<br />

Merck Sharp & Dohme Idea<br />

Inc.<br />

30/04/04<br />

30/04/04<br />

13200 Tifol Acidum folicum Film-coated tablets 0,4 mg KRKA d.d., Novo mesto 31/12/08<br />

13201 Tiger Balm Red Ointment Drug Houses of Australia<br />

(Asia) Ptc. Ltd.<br />

13202 Tiger Balm White Ointment Drug Houses of Australia<br />

(Asia) Ptc. Ltd.<br />

13203 Tiguvon 10 Fention Solution for veterinary<br />

use<br />

13204 Tiguvon 20 Fention Solution for veterinary<br />

use<br />

31/12/04<br />

31/12/04<br />

Bayer 31/12/08<br />

Bayer 31/12/08<br />

13205 Tikalutamid Bicalutamidum Film-coated tablets 50 mg Instytut Farmaceutyczny 31/12/08<br />

13206 Tikosyn Dofetilidum Capsules 125 mcg Pfizer European Service 31/12/08<br />

13207 Tikosyn Dofetilidum Capsules 250 mcg Pfizer European Service 31/12/08<br />

13208 Tikosyn Dofetilidum Capsules 500 mcg Pfizer European Service 31/12/08<br />

13209 Tilade Nedocromilum Inhalation areosol 2 mg/dawke˛<br />

inhalacyjna˛<br />

13210 Tilade Mint Nedocromilum Pressurised inhalation,<br />

suspension<br />

2 mg/dawke˛<br />

inhalacyjna˛<br />

Rhône-Poulenc Rorer Fisons<br />

Ltd.<br />

Rhône-Poulenc Rorer Fisons<br />

Ltd.<br />

13211 Tilarin Nedocromilum Nasal spray, solution 1.3 mg/dawke˛ Rhône-Poulenc Rorer Fisons<br />

Ltd.<br />

13212 Tilavist Nedocromilum Eye drops, solution 20 mg/ml Rhône-Poulenc Rorer Fisons<br />

Ltd.<br />

13213 Tilclor Tylozyny winian,<br />

Chlorotetracykliny<br />

chlorowodorek<br />

13214 Tilinax Tilidini hydrochloridum,<br />

Naloxoni<br />

hydrochloridum<br />

13215 Tilinax Tilidini hydrochloridum,<br />

Naloxoni<br />

hydrochloridum<br />

Powder for veterinary<br />

use<br />

30/04/04<br />

2/07/06<br />

31/03/07<br />

12/12/06<br />

Vetem 18/09/05<br />

Capsules 50 mg + 4 mg HEXAL AG 31/12/08<br />

Oral drops, solution (50 mg +<br />

4 mg)/0,72 ml<br />

13216 Tiljet 20 Tylozyna Solution for veterinary<br />

use<br />

13217 Tilsol 200 Tylozyny winian Powder for veterinary<br />

use<br />

13218 Timentin Acidum clavulanicum +<br />

Ticarcillinum<br />

13219 Timentin Acidum clavulanicum +<br />

Ticarcillinum<br />

Powder for solution<br />

for intravascular<br />

injection and infusion<br />

Powder for solution<br />

for intravascular<br />

injection and infusion<br />

HEXAL AG 31/12/08<br />

Vetem 4/03/04<br />

Vetem 31/01/05<br />

100mg + 1,5g SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

200mg + 3g SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

13220 Timo — Comod 0,25 % Timololum Eye drops 2,5 mg/ml Ursapharm Arzneimittel<br />

GmbH<br />

30/04/04<br />

30/04/04<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1317<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13221 Timo — Comod 0,5 % Timololum Eye drops 5 mg/ml Ursapharm Arzneimittel<br />

GmbH<br />

31/12/08<br />

13222 Timo — Stulln 0,25 % Ud Timololum Eye drops, solution 2,5 mg/ml Pharma Stulln GmbH 31/12/08<br />

13223 Timo — Stulln 0,5 % Ud Timololum Eye drops, solution 5 mg/ml Pharma Stulln GmbH 31/12/08<br />

13224 Timohexal 0,1 % Timololum Eye drops 1 mg/ml Hexal AG 31/05/04<br />

13225 Timohexal 0,25 % Timololum Eye drops 2.5 mg/ml Hexal AG 31/05/04<br />

13226 Timohexal 0,5 % Timololum Eye drops 5 mg/ml Hexal AG 31/05/04<br />

13<strong>227</strong> Timolol-POS 0,25 % Timololum Eye drops 2.5 mg/ml Ursapharm Arzneimittel<br />

GmbH& CoKG<br />

13228 Timolol-POS 0,5 % Timololum Eye drops 5 mg/ml Ursapharm Arzneimittel<br />

GmbH& CoKG<br />

14/02/07<br />

14/02/07<br />

13229 Timonil Carbamazepinum Oral suspension 100 mg/5 ml Desitin Arznemittel GmbH 31/12/08<br />

13230 Timonil 150 retard Carbamazepinum Prolonged release<br />

tablets<br />

150 mg Desitin Arznemittel GmbH 31/12/08<br />

13231 Timonil 200 Carbamazepinum Tablets 200 mg Desitin Arznemittel GmbH 31/12/08<br />

13232 Timonil 300 retard Carbamazepinum Prolonged release<br />

tablets<br />

13233 Timonil 600 retard Carbamazepinum Prolonged release<br />

tablets<br />

300 mg Desitin Arznemittel GmbH 31/12/08<br />

600 mg Desitin Arznemittel GmbH 31/12/08<br />

13234 Timoptic 0,25 % Timololum Eye drops, solution 2.5 mg/ml Merck Sharp & Dohme Idea<br />

Inc.<br />

13235 Timoptic 0,5 % Timololum Eye drops, solution 5 mg/ml Merck Sharp & Dohme Idea<br />

Inc.<br />

13236 Timoptic-XE 0,25 % Timololum Eye drops, solution 2.5 mg/ml Merck Sharp & Dohme Idea<br />

Inc.<br />

13237 Timoptic-XE 0,5 % Timololum Eye drops, solution 5 mg/ml Merck Sharp & Dohme Idea<br />

Inc.<br />

13238 Tinctura Ammi visnagae —<br />

nalewka z Aminka egipskiego<br />

13239 Tinctura Arnicae — nalewka z<br />

kwiatu Arniki<br />

13240 Tinctura Calendulae Calendulae anthodium<br />

tinctura<br />

13241 Tinctura Crataegi Crataegi inflorescentiae<br />

tinctura<br />

13242 Tinctura cynarae Cynarae herbae<br />

extractum fluidum<br />

Preparat ziołowy Tincture Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

Tincture Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

30/06/04<br />

30/06/04<br />

14/03/06<br />

14/03/06<br />

31/12/04<br />

31/12/04<br />

Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

Oral solution 925mg/ml Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

Oral solution K.Z.Z. ‘Herbapol’ S.A. w<br />

Krakowie<br />

13243 Tinctura Ginkgo Bilobae Ginkgo biloba tinctura Oral solution 935 mg/ml Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

13244 Tinctura Ginko Bilobae Ginkgo bilobae folium<br />

tinctura<br />

30/10/05<br />

31/12/08<br />

30/09/05<br />

Oral solution Phytopharm Kle˛ka S.A. 30/10/05<br />

13245 Tinctura Hyperici Hyperici herbae tinctura Oral solution Phytopharm Kle˛ka S.A. 30/10/05


EN<br />

1318 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13246 Tinctura Hyperici Hyperici herbae tinctura Oral solution Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

13247 Tinctura Hyperici — nalewka z<br />

Dziurawca<br />

30/10/05<br />

Hyperici herbae tinctura Tincture Herbapol Łódz´ S.A. 31/12/07<br />

13248 Tinctura Salviae Salviae folium tinctura Oromucosal solution Phytopharm Kle˛ka S.A. 30/10/05<br />

13249 Tinctura Salviae Salviae folium tinctura Oral solution 990mg/ml Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

13250 Tinctura Salviae — nalewka z<br />

lis´ci Szałwii<br />

30/10/05<br />

Salviae folium tinctura Tincture Herbapol Łódz´ S.A. 31/12/07<br />

13251 Tinidazolum Tinidazolum Film-coated tablets 500 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

13252 Tinidazolum 0,2 % in Glucosi<br />

5%<br />

Tinidazolum + Glucosum Solution for<br />

intravenous infusion<br />

Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/01/06<br />

31/05/05<br />

13253 Tiomersal Pharma Zentrale 9/01/05<br />

13254 Tiquanis Dichlorfos, Fenitotion Spray for veterinary<br />

use<br />

13255 Tirotax Cefotaximum Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

and for infusion<br />

13256 Tirsan 200 Solution Tiamfenikol Solution for veterinary<br />

use<br />

13257 Tirsan Injection Tiamfenikol Solution for veterinary<br />

use<br />

13258 Tirsan Premix Tiamfenikol Premix for veterinary<br />

use<br />

Vetoquinol 3/06/06<br />

1 g Biochemie GmbH — Kundl 17/01/07<br />

Fatro 7/04/05<br />

Fatro 7/04/05<br />

Fatro 30/06/05<br />

13260 Tisercin Levomepromazinum Film-coated tablets 25 mg Egis Pharmaceuticals Ltd. 30/06/04<br />

13259 Tisercin Levomepromazinum Solution for injection 25 mg/1 ml Egis Pharmaceuticals Ltd. 30/06/04<br />

13261 Tissucol Kit Set for tissular glue Baxter AG 31/07/04<br />

13262 Tlen Medyczny Oxygenium Eurogaz — Gdynia 31/07/05<br />

13263 Tlen Medyczny Oxygenium Messer Polska Sp. z o.o. 31/07/05<br />

13264 Tlen medyczny Gas ALKAT Sp. z o.o. 31/07/05<br />

13265 Tlen medyczny Gas AGA Gaz Sp. z o.o. 31/07/05<br />

13266 Tlen medyczny Gas Poligaz S.A. 31/08/05<br />

13267 Tlen medyczny Gas Praxair Polska Sp.z.o.o 28/09/05<br />

13268 Tlen medyczny Gas Linde Gaz Sp. z o.o. 14/12/05<br />

13269 Tlen medyczny Gas BOC Gazy Sp. z o.o. 6/12/06<br />

13270 Tlen Medyczny Spre˛z˙ony i<br />

Ciekły<br />

Oxygenium Eurogaz Sp. z o.o., Bydgoszcz 31/12/08<br />

13271 Tlenek cynku A.C.E.F., Włochy 31/12/08<br />

13272 Tlenek cynku Cefarm Gdańsk 31/12/08<br />

13273 Tlenek cynku Hasco-Lek, Wrocław 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1319<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13274 Tlenek cynku Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

31/12/08<br />

13275 Tlenek cynku Pampa, Piaseczno 31/12/08<br />

13276 Tobacoff Buccal tablet Zakłady Farmaceutyczne<br />

Colfarm<br />

13277 Tobradex Dexamethasonum +<br />

Tobramycinum<br />

4/10/06<br />

Eye drops, suspension Alcon Couvreur N.V. 16/05/07<br />

13278 Tobramycyna WZF 0,3 % Tobramycinum Eye drops 3 mg / ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

13279 Tobrex Tobramycinum Eye drops, solution 3 mg/ml Alcon Couvreur N.V. 30/06/04<br />

13280 Tobrex Tobramycinum Eye ointment 3 mg/g Alcon Couvreur N.V. 30/06/04<br />

13281 Togal ASS 400 Acidum acetylsalicylicum Tablets 0.4 g Togal Werk A.G. 31/12/07<br />

13282 Togrel Clopidogrelum Film-coated tablets 75 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

13283 Tointex Allantoinum +<br />

Heparinum<br />

Cream (20mg +<br />

50j.m.)/g<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

13284 Tokovit 100 Tocopherolum Capsules, soft 100 j.m. Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

13285 Tokovit 200 Tocopherolum Capsules, soft 200 j.m. Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

13286 Tokovit 400 Tocopherolum Capsules, soft 400 j.m Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

13287 Tokovit A+E forte Retinolum +<br />

Tocopherolum<br />

13288 Tokovit A+E mite Retinolum +<br />

Tocopherolum<br />

13289 Tolargin Atropinum +<br />

Metamizolum natricum<br />

+ Papaverinum<br />

Capsules, soft 2500 j.m. +<br />

200 j.m.<br />

Capsules, soft 2500 j.m. +<br />

70 j.m.<br />

Suppository 0,8mg +<br />

300mg +<br />

40mg<br />

13290 Tolfedine 4 % Kwas tolfenamowy Solution for veterinary<br />

use<br />

13291 Tolfedine 6 mg Kwas tolfenamowy Tablet for veterinary<br />

use<br />

13292 Tolfedine 60 mg Kwas tolfenamowy Tablet for veterinary<br />

use<br />

13293 Tolfine Kwas tolfenamowy Solution for veterinary<br />

use<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/12/08<br />

31/01/06<br />

14/12/05<br />

14/12/05<br />

14/12/05<br />

9/08/06<br />

9/08/06<br />

31/12/05<br />

Vetoquinol S.A. 20/08/06<br />

Vatoquinol 6/08/06<br />

Vatoquinol 6/08/06<br />

Vetoquinol 30/09/07<br />

13294 Tolperis Tolperisonum Film-coated tablets 50 mg ICN Polfa Rzeszów S.A. 27/06/07<br />

13295 Tołpa Chamosaldont Gel Gel Torf Corporation sp. z o.o.<br />

Fabryka Leków<br />

13296 Tołpa Hypocalen Gel Gel Torf Corporation sp. z o.o.<br />

Fabryka Leków<br />

13297 Tołpa procto-hypocalen gel Gel Torf Corporation, Ka˛ty<br />

Wrocławskie<br />

13298 Tomapyrin Acidum acetylsalicylicum<br />

+ Coffeinum +<br />

Paracetamolum<br />

Tablets 250mg +<br />

50mg +<br />

200mg<br />

Boehringer Ingelheim<br />

International GmbH<br />

31/12/04<br />

31/12/04<br />

31/12/08<br />

31/07/04


EN<br />

1320 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13299 Tomapyrin C Acidum acetylsalicylicum<br />

+ Acidum ascorbicum<br />

(vit C) + Paracetamolum<br />

Effervescent tablets 300mg +<br />

300mg +<br />

200mg<br />

Boehringer Ingelheim<br />

International GmbH<br />

13300 Tomapyrin Comfort Acidum acetylsalicylicum Chewable tablets 500 mg Boehringer Ingelheim<br />

International GmbH<br />

13301 Tomudex Raltitrexed Powder for solution<br />

for infusion<br />

13302 Toncils Benzocainum +<br />

Chlorhexidinum<br />

31/01/06<br />

31/12/08<br />

2 mg AstraZeneca UK Ltd. 31/08/05<br />

Buccal tablets Vitabalans Oy 31/12/08<br />

13303 Tonico-Injeel Amp. Heel GmbH 31/12/08<br />

13304 Tonicol Herbal tea Eldex-Medical 2/10/06<br />

13305 Tonicol Instant herbal tea Eldex-Medical 2/10/06<br />

13306 Tonicol-fix Instant herbal tea P.P.H. ‘Eldex-Medical’, Wiry 31/12/08<br />

13307 Tonique vegetal Drops Lehning Laboratoires 4/01/07<br />

13308 Tonocalcin Calcitoninum salmonis Nasal spray, liquid 200 j.m./dawke˛ Alfa Wassermann S.p.A. 26/04/06<br />

13309 Tonocalcin Calcitoninum salmonis Solution for injection 100 j.m/ml Alfa Wassermann S.p.A. 26/04/06<br />

13310 Tonocalcin Calcitoninum salmonis Solution for injection 50 j.m/ml Alfa Wassermann S.p.A. 26/04/06<br />

13311 Tonsilgon N Oral drops, solution Bionorica Arzneimittel GmbH 31/12/08<br />

13312 Tonsilla Compositum Amp. Heel GmbH 31/12/08<br />

13313 Tonsillopas krople Pascoe Pharmaceutische<br />

Preparate GmbH<br />

13314 Tonsiotren H Tablets DHU-Arzneimittel GmbH &<br />

Co.KG<br />

13315 Top C Acidum ascorbicum (vit<br />

C)<br />

Tablets G.R. Lane Health Products<br />

Ltd.<br />

30/11/05<br />

31/08/05<br />

30/06/04<br />

13316 Topamax Topiramatum Capsules 15 mg Cilag AG 14/12/05<br />

13317 Topamax Topiramatum Capsules 25 mg Cilag AG 14/12/05<br />

13318 Topamax Topiramatum Film-coated tablets 100 mg Cilag AG 31/12/08<br />

13319 Topamax Topiramatum Film-coated tablets 200 mg Cilag AG 31/12/08<br />

13320 Topamax Topiramatum Film-coated tablets 25 mg Cilag AG 31/12/08<br />

13321 Topamax Topiramatum Film-coated tablets 50 mg Cilag AG 31/12/08<br />

13322 Topiramat Topiramatum Tablets PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

13323 Toradol Ketorolacum Solution for injection 30 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

13324 Toradol Ketorolacum Tablets 10 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

13325 Torasemide Torasemidum Tablets 2,5 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

13326 Torasemide Torasemidum Tablets 20 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

13327 Torasemide Torasemidum Tablets 10 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/12/08<br />

31/05/04<br />

31/05/04<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1321<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13328 Torasemide Torasemidum Tablets 5 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

13329 Torasemide Torasemidum Tablets 10 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

13330 Torasemide Tovasemidum Tablets 5 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

13331 Torbugesic Inj. Butorfanolu winian Solution for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

Fort Dodge 31/12/08<br />

13334 Torecan Thiethylperazinum Film-coated tablets 6.5 mg Krka d.d., Novo mesto 31/07/04<br />

13333 Torecan Thiethylperazinum Solution for injection 6.5 mg/1 ml Krka d.d., Novo mesto 31/07/04<br />

13332 Torecan Thiethylperazinum Suppository 6.5 mg Krka d.d., Novo mesto 31/07/04<br />

13335 Tormentilla comp. Amp. 1 ml WALA-Heilmittel GmbH 24/05/07<br />

13336 Tormentilla comp. Granules WALA-Heilmittel GmbH 24/05/07<br />

13337 Tormentiol Preparat złoz˙ony Ointment GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/03/04<br />

13338 Torospar Sparfloxacinum Film-coated tablets 200 mg Torrent Pharmaceuticals, Ltd. 31/12/08<br />

13339 Totocillin Ampicillinum +<br />

Oxacillinum<br />

Suspension for veterinary<br />

use<br />

13340 Tracrium Atracurii besilas Solution for injection<br />

or intravenous<br />

infusion<br />

13341 Tractocile Atosibanum Concentrate for<br />

solution for infusion<br />

Bayer 31/12/08<br />

10 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

30/06/04<br />

7.5 mg/ml Ferring AB 12/10/05<br />

13342 Tractocile Atosibanum Solution for injection 7.5 mg/ml Ferring AB 12/10/05<br />

13343 Tracutil Concentrate for<br />

solution for<br />

intravenous infusion<br />

B. Braun Melsungen AG 27/03/06<br />

13345 Tradol Tramadolum Capsules 50 mg HEXAL AG 31/12/08<br />

13348 Tradol Tramadolum Effervescent tablets 50 mg HEXAL AG 31/12/08<br />

13346 Tradol Tramadolum Oral solution 100 mg/ml HEXAL AG 31/12/08<br />

13344 Tradol Tramadolum Suppository 100 mg HEXAL AG 31/12/08<br />

13347 Tradol Tramadolum Tablets 50 mg HEXAL AG 31/12/08<br />

13349 Tradol 100 Tramadolum Solution for<br />

intramuscular,<br />

intravenous and<br />

subcutaneous<br />

injection and for<br />

intravascular infusion<br />

13350 Tradol 100 Id Tramadolum Prolonged release<br />

tablets<br />

13351 Tradol 150 Id Tramadolum Prolonged release<br />

tablets<br />

13352 Tradol 200 Id Tramadolum Prolonged release<br />

tablets<br />

100 mg/2 ml HEXAL AG 31/12/08<br />

100 mg HEXAL AG 31/12/08<br />

150 mg HEXAL AG 31/12/08<br />

200 mg HEXAL AG 31/12/08


EN<br />

1322 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13353 Tradol 50 Tramadolum Solution for<br />

intramuscular,<br />

intravenous and<br />

subcutaneous<br />

injection and for<br />

intravascular infusion<br />

50 mg/ml HEXAL AG 31/12/08<br />

13354 Tradolan Retard Tramadolum Film-coated tablets 100 mg Lannacher — Centralne<br />

Laboratorium<br />

Farmaceutyczne<br />

13359 Tramadol Tramadolum Capsules 50 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

13360 Tramadol Tramadolum Capsules 50 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

13361 Tramadol Tramadolum Capsules 50 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

30/01/05<br />

31/03/06<br />

6/07/05<br />

13362 Tramadol Tramadolum Drops 100 mg/ml KRKA d.d., Novo mesto 30/06/04<br />

13357 Tramadol Tramadolum Injection 100 mg/2 ml KRKA d.d., Novo mesto 30/06/04<br />

13358 Tramadol Tramadolum Injection 50 mg/ml KRKA d.d., Novo mesto 30/06/04<br />

13363 Tramadol Tramadolum Oral drops, solution 100 mg/ml Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

13364 Tramadol Tramadolum Solution for<br />

subcutaneous,<br />

intramuscular,<br />

intravenous injection<br />

50 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/03/06<br />

31/01/05<br />

13355 Tramadol Tramadolum Suppository 100 mg KRKA d.d., Novo mesto 30/06/04<br />

13356 Tramadol Tramadolum Suppository 100 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

31/12/05<br />

13365 Tramadol Tramadolum Tablets 50 mg KRKA d.d., Novo mesto 30/06/04<br />

13366 Tramadol Stada Tramadolum Capsules 50 mg STADApharm GmbH 31/12/08<br />

13367 Tramadol — Stada Tramadolum Drops 100 mg/ml STADApharm GmbH 31/12/08<br />

13368 Tramadol — Stada Tramadolum Solution for injection 100 mg/2 ml STADApharm GmbH 31/12/08<br />

13369 Tramadol Retard Tramadolum Prolonged release<br />

tablets<br />

13370 Tramadol Retard Tramadolum Prolonged release<br />

tablets<br />

13371 Tramadol Retard Tramadolum Prolonged release<br />

tablets<br />

150 mg KRKA d.d., Novo mesto 31/12/08<br />

100 mg KRKA d.d., Novo mesto 31/12/08<br />

200 mg KRKA d.d., Novo mesto 31/12/08<br />

13375 Tramadol-Lannacher Tramadolum Film-coated tablets 50 mg Lannacher Heilmittel GmbH 29/06/05<br />

13373 Tramadol-Lannacher Tramadolum Oral drops 100 mg/ml Lannacher Heilmittel GmbH 29/06/05<br />

13374 Tramadol-Lannacher Tramadolum Solution for injection 50 mg/ml Lannacher Heilmittel GmbH 29/06/05<br />

13372 Tramadol-Lannacher Tramadolum Suppository 100 mg Lannacher Heilmittel GmbH 29/06/05<br />

13378 Tramal Tramadolum Capsules 50 mg Grunenthal GmbH 31/07/04<br />

13379 Tramal Tramadolum Capsules 50 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

31/01/06<br />

13380 Tramal Tramadolum Oral drops, solution 100 mg/ml Grunenthal GmbH 31/07/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1323<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13381 Tramal Tramadolum Oral drops, solution 100 mg/ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

13382 Tramal Tramadolum Solution for injection 50 mg/ml Grünenthal GmbH 31/07/04<br />

13376 Tramal Tramadolum Suppository 100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

18/09/05<br />

13377 Tramal Tramadolum Suppository 100 mg Grunenthal GmbH 31/07/04<br />

13383 Tramal Tramadolum Tablets for oral<br />

suspension<br />

50 mg Grunenthal GmbH 21/03/07<br />

13384 Tramal 100 Tramadolum Solution for injection 50 mg/1ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

13385 Tramal 50 Tramadolum Solution for injection 50 mg/1 ml Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

13387 Tramal Retard 100 Tramadolum Film-coated, prologed<br />

release tablets<br />

13386 Tramal Retard 100 Tramadolum Prolonged release<br />

tablets<br />

13389 Tramal Retard 150 Tramadolum Film-coated, prologed<br />

release tablets<br />

13388 Tramal Retard 150 Tramadolum Prolonged release<br />

tablets<br />

13391 Tramal Retard 200 Tramadolum Film-coated, prologed<br />

release tablets<br />

13390 Tramal Retard 200 Tramadolum Prolonged release<br />

tablets<br />

100 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

100 mg Grünenthal GmbH 31/12/08<br />

150 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

150 mg Grünenthal GmbH 31/12/08<br />

200 mg Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

30/10/05<br />

200 mg Grünenthal GmbH 31/12/08<br />

13392 Tramisal Beaufour-Ipsen 31/12/08<br />

13393 Tramundin Tramadolum Prolonged release<br />

tablets<br />

100 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

6/06/07<br />

13394 Tran Calcii lactogluconas Liquid ICHEM Sp. z o.o. 5/07/05<br />

13395 Tran Capsules 0.57 g Vitamex AB 31/07/04<br />

13396 Tran Capsules Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

13397 TRAN W PŁYNIE O Smaku<br />

Pomarańczowym<br />

5/07/05<br />

Vitamin A, Vitamin B VITAMEX AB 31/12/08<br />

13398 Tran z olejem wiesiołkowym Capsules Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

31/12/05<br />

13399 Tran z watroby dorsza Oral solution Lysi HF 31/07/04<br />

13400 Tran z watroby dorsza — o<br />

smaku mie˛towym<br />

Oral solution Lysi HF 31/07/04<br />

13401 Tran z wa˛troby dorsza Capsules Lysi HF 31/07/04<br />

13402 Tran z wa˛troby dorsza Liquid Lysi HF 31/07/04<br />

13403 Tran z wa˛troby dorsza — o<br />

smaku owocowym<br />

13404 Trankwilina Chlorhexidinum Solution for veterinary<br />

use<br />

Oral solution Lysi HF 31/07/04<br />

Biowet Puławy 26/04/04


EN<br />

1324 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13405 Transilane® Psyllii semen Powder for oral<br />

suspension<br />

13406 Transilane® sugar free Psyllii semen Powder for oral<br />

suspension<br />

2,816g/7g Laboratoire Innotech<br />

International<br />

2,816g/7g Laboratoire Innotech<br />

International<br />

31/12/08<br />

31/12/08<br />

13407 Transpulmin S Cream Asta Medica AG 30/06/04<br />

13408 TRANSTEC 35 µG/H Buprenorphinum Transdermal patch 35 µg/h Grünenthal GmbH 31/12/08<br />

13409 TRANSTEC 52,5 µG/H Buprenorphinum Transdermal patch 52,5 µg/h Grünenthal GmbH 31/12/08<br />

13410 TRANSTEC 70 µG/H Buprenorphinum Transdermal patch 70 µg/h Grünenthal GmbH 31/12/08<br />

13411 Tranvit Omega-3-trójglicerydy Capsules, soft Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

12/10/05<br />

13412 Tranxene Dikalii clorazepas Film-coated tablets 50 mg Sanofi Winthrop-Gentilly 25/01/06<br />

13413 Tranxene Kalii clorazepas Capsules 10 mg Sanofi Winthrop-Gentilly 30/04/04<br />

13414 Tranxene Kalii clorazepas Capsules 5 mg Sanofi Winthrop-Gentilly 30/04/04<br />

13415 Tranxene 10 Dikalii clorazepas Capsules 10 mg Sanofi-Synthelabo Sp. z o.o. 30/11/05<br />

13416 Tranxene 100 Dikalii clorazepas Lyophilisate and<br />

solvent for solution<br />

for intramuscular and<br />

intravenous injection<br />

13417 Tranxene 20 Dikalii clorazepas Lyophilisate and<br />

solvent for solution<br />

for intramuscular and<br />

intravenous injection<br />

100 mg Sanofi Winthrop-Gentilly 19/12/05<br />

20 mg Sanofi Winthrop-Gentilly 19/12/05<br />

13418 Tranxene 5 Dikalii clorazepas Capsules 5 mg Sanofi-Synthelabo Sp. z o.o. 30/11/05<br />

13419 Tranxene 50 Dikalii clorazepas Lyophilisate and<br />

solvent for solution<br />

for intramuscular and<br />

intravenous injection<br />

50 mg Sanofi Winthrop-Gentilly 19/12/05<br />

13421 Traskolan Aprotininum Oromucosal gel 0,5 j.Ph.Eur/g Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

13420 Traskolan Aprotininum Solution for<br />

intravenous injection<br />

and intravenous<br />

infusion<br />

13422 Traumaplant Symphyti herbae<br />

extractum<br />

500000 J.I.K/<br />

10ml<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

Cream 25g Harras Pharma Curarina<br />

Arzneimittel GmbH<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

13423 Traumeel S Amp. Heel GmbH 30/06/07<br />

13424 Traumeel S Drops Heel GmbH 30/06/07<br />

13425 Traumeel S Ointment Heel GmbH 30/06/07<br />

13426 Traumeel S Tablets Heel GmbH 30/06/07<br />

13427 Traumentol Gel M.C.M. Klosterfrau<br />

Vetriebsgesellschaft m.b.H<br />

31/12/05<br />

13429 Traumon Etofenamatum Gel 10 % Bayer AG 31/12/07<br />

13428 Traumon Etofenamatum Spray 0.1 g/ml Bayer AG 31/12/07<br />

13430 Travatan Eye drops, solution 40 mcg/ml Alcon Laboratoires UK Ltd. 21/03/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1325<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13431 Travocort Diflucortolonum +<br />

Isoconazolum<br />

Cream Schering AG 30/06/05<br />

13432 Travogen Isoconazolum Cream 10 mg/g Schering AG 30/04/04<br />

13433 Tra˛dzik młodzieńczy<br />

HomeoPorady<br />

13434 Trempex Glukonian<br />

chlorheksydyny<br />

Liquid for veterinary<br />

use<br />

Laboratoires BOIRON 4/07/07<br />

Hypred 31/12/08<br />

13435 Trental Pentoxifyllinum Solution for injection 20 mg/ml Hoechst Marion Roussel<br />

Deutschland GmbH<br />

13436 Trental 400 Pentoxifyllinum Coated tablets 400 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

30/06/04<br />

30/06/04<br />

13437 Trexan Methotrexatum Tablets 2.5 mg Orion Corporation 31/05/04<br />

13438 Tri — Regol Ethinylestradiolum +<br />

Levonorgestrelum<br />

13439 Triaklim Estradiolum +<br />

Norethisteronum<br />

13440 Tri-alplucine Jozomycyna,<br />

trimetoprim<br />

Film-coated tablets Chemical Works of Gedeon<br />

Richter Ltd.<br />

Film-coated tablets Chemical Works of Gedeon<br />

Richter Ltd.<br />

Powder for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

Virbac 31/12/08<br />

13441 Triamteren Triamterenum Tablets 50 mg Instytut Farmaceutyczny 30/11/05<br />

13442 Tribiotic Bacitracinum +<br />

Neomycinum +<br />

Polymyxinum B<br />

Ointment Kato LABS Sp. z o.o. 31/12/08<br />

13443 Tribux Trimebutinum Tablets 100 mg Biofarm Sp.z.o.o<br />

Przdsie˛biorstwo Produkcyjno<br />

— Handlowo — Usługowe<br />

13444 Tricho Plus Ronidazol Powder for veterinary<br />

use<br />

26/04/06<br />

Laboratoria Smeets 30/06/04<br />

13445 Trichomex Metronidazolum Tablets 250 mg CYNTFARM Sp. z o.o.,<br />

Pruszków<br />

13446 Trichonidazol Ronidazol dla gołe˛bi Powder for veterinary<br />

use<br />

13447 Triderm Betamethasonum +<br />

Clotrimazolum +<br />

Gentamicinum<br />

13448 Triderm Betamethasonum +<br />

Clotrimazolum +<br />

Gentamicinum<br />

13449 Tridox LA Oxytetracyclinum Solution for veterinary<br />

use<br />

13450 Trienyl Omega-3-trójglicerydy +<br />

Tocopherolum<br />

13451 Trifas 10 Torasemidum Solution for<br />

intravenous injection<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego S.A.<br />

31/12/08<br />

20/06/05<br />

Cream Schering-Plough Labo N.V. 31/03/04<br />

Ointment Schering-Plough Farma Lda 31/03/04<br />

Vetimex 31/12/08<br />

Capsules 500 mg Lek Pharmaceuticals d.d. 30/04/04<br />

5 mg/ml Berlin-Chemie AG (Menarini<br />

Group)<br />

13452 Trifas 10 Torasemidum Tablets 10 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

13453 Trifas 20 Torasemidum Solution for<br />

intravenous injection<br />

5 mg/ml Berlin-Chemie AG (Menarini<br />

Group)<br />

31/01/05<br />

31/01/05<br />

31/01/05


EN<br />

1326 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13454 Trifas 200 Torasemidum Solution for<br />

intravenous infusion<br />

10 mg/ml Berlin-Chemie AG (Menarini<br />

Group)<br />

13455 Trifas 200 Torasemidum Tablets 200 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

13456 Trifas COR Torasemidum Tablets 5 mg Berlin-Chemie AG (Menarini<br />

Group)<br />

13457 Triherpine Trifluridinum Eye drops 1 % Novartis Ophthalmics AG<br />

Hettlingen<br />

13458 Triherpine Trifluridinum Eye ointment 1 % Novartis Ophthalmics AG<br />

Hettlingen<br />

13459 Trilac Bakterie kwasu<br />

mlekowego<br />

Capsules 1.6 mld<br />

bakterii kwasu<br />

mlekowego<br />

31/01/05<br />

31/01/05<br />

31/01/05<br />

31/12/06<br />

31/12/06<br />

Allergon AB 31/03/04<br />

13460 Trilafon Perphenazinum Coated tablets 8 mg Schering-Plough Labo N.V. 31/05/04<br />

13462 Trilafon Perphenazinum Film-coated tablets 2 mg Schering-Plough Labo N.V. 31/08/04<br />

13463 Trilafon Perphenazinum Film-coated tablets 4 mg Schering-Plough Labo N.V. 31/08/04<br />

13461 Trilafon Perphenazinum Solution for injection 5 mg/1 ml Schering-Plough Labo N.V. 31/05/04<br />

13464 Trilafon enanthate Perphenazinum Solution for injection 100 mg/1ml Schering-Plough Labo N.V. 31/05/04<br />

13465 Trileptal Oxcarbazepinum Film-coated tablets 150 mg Novartis Pharma AG 6/07/05<br />

13466 Trileptal Oxcarbazepinum Film-coated tablets 300 mg Novartis Pharma AG 6/07/05<br />

13467 Trileptal Oxcarbazepinum Film-coated tablets 600 mg Novartis Pharma AG 6/07/05<br />

13468 Trileptal Oxcarbazepinum Oral suspension 60 mg/ml Novartis Pharma AG 31/12/07<br />

13469 Trimebutine Trimebutini maleas Tablets 100 mg Farmaceutyczna Spółdzielnia<br />

Pracy ‘GALENA’<br />

13470 Trimerazin Sulfamerazyna,<br />

Trimetoprim<br />

13471 Trimerazin Sulfamerazyna,<br />

Trimetoprim<br />

Powder for veterinary<br />

use<br />

Tablet for veterinary<br />

use<br />

Grodziskie Zakłady<br />

Farmaceutyczne Polfa<br />

Grodziskie Zakłady<br />

Farmaceutyczne Polfa<br />

31/12/08<br />

21/05/04<br />

31/12/08<br />

13472 Trimesan Trimethoprimum Tablets 100 mg Sun-Farm Sp.z o.o. Kołbiel 31/12/08<br />

13473 Trimesan Trimethoprimum Tablets 200 mg Sun-Farm Sp. z o.o. 31/12/08<br />

13474 Trimetaratio Trimetazidinum Film-coated tablets 20 mg ratiopharm GmbH 25/10/06<br />

13475 Trimetazydyny<br />

Dichlorowodorek<br />

Trimetazidinum Film-coated tablets 35 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

13476 Trimetoprim Polfa Pabianice 31/12/08<br />

13477 Trimetoprim Scholz, Sowin 31/12/08<br />

13478 Trimetosul 48 % Iniekcje Trimethoprium +<br />

Sulphadiazinum<br />

13479 Trimetosul 48 % Zawiesina<br />

doustna<br />

Trimethoprium +<br />

Sulphadiazinum<br />

13480 Tri-Minulet Ethinylestradiolum +<br />

Gestodenum<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Pliva Kraków 30/06/04<br />

Pliva Kraków 30/06/04<br />

Film-coated tablets Wyeth-Lederle Pharma GmbH 30/11/04<br />

13481 Trimline Capsules G.R. Lane Health Products<br />

Ltd.<br />

31/07/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1327<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13482 Trimonit Glyceroli trinitras Sublingual spray 400 mcg/<br />

dawke˛<br />

13483 Trimovax R.O.R. Morbilli, combinations<br />

with parotitis and<br />

rubella, live attenuated<br />

13484 Trimsulfasol Trimethoprinum +<br />

Sulphametoxasolum<br />

13485 Trinordiol 21 Ethinylestradiolum +<br />

Levonorgestrelum<br />

13486 Trinovum Ethinylestradiolum +<br />

Norethisteronum<br />

Lyophilisate and solvent for solution for<br />

subcutaneous or intramuscular injection<br />

Solution for veterinary<br />

use<br />

Sanofi-Synthelabo Sp. z o.o. 30/04/06<br />

Aventis Pasteur S.A. 31/01/05<br />

Dopharma 31/12/08<br />

Coated tablets Wyeth Pharma GmbH 30/04/04<br />

Tablets tabletki białe:<br />

0,035 mg<br />

ethinylestradiolu<br />

i 0,5 mg<br />

norethisteronu;<br />

tabletki<br />

jasnomorelowe:<br />

0,035 mg<br />

ethinylestradiolu<br />

i 0,75 mg<br />

norethisteronu;<br />

tabletki<br />

morelowe:<br />

0,035 mg<br />

ethinylestradiolu<br />

i 1 mg<br />

norethisteronu.<br />

13487 Trioxyl L.A. Amoxicillunum Suspension for veterinary<br />

use<br />

13488 Tripacel Diphtheria-tetanuspertussis<br />

13489 Tripoten Muira Puama lignum<br />

extr. + Damianae folium<br />

extr. + Eleutherococci<br />

rhisoma extractum<br />

13490 Triprim Sulfadimetylopirymidyna,<br />

Trimetoprim<br />

13491 Triquilar Ethinylestradiolum +<br />

Levonorgestrelum<br />

13492 Tri-Regol Ethinylestradiolum +<br />

Levonorgestrelum<br />

13493 Trisequens Estradiolum +<br />

Norethisteronum<br />

13494 Trisequens Forte Estradiolum +<br />

Norethisteronum<br />

Suspension for<br />

intramuscular<br />

injection<br />

Capsules, hard (100mg +<br />

100mg +<br />

30mg)<br />

Solution for veterinary<br />

use<br />

Cilag AG 30/06/04<br />

Univet LTD 19/01/04<br />

1 dawka Aventis Pasteur Limited 31/01/05<br />

PT. Dexa Medica 31/12/08<br />

Richter Pharma AG 23/11/05<br />

Film-coated tablets Schering AG 31/07/04<br />

Tablets tabletki z˙ółte:<br />

0,03 mg<br />

ethinylestradiolu<br />

i 0,05 mg<br />

levonorgestrelu;<br />

tabletki<br />

morelowe:<br />

0,04 mg<br />

ethinylestradiolu<br />

i 0,075 mg<br />

levonorgestrelu;<br />

tabletki białe:<br />

0,03 mg<br />

ethinylestradiolu<br />

i 0,125 mg<br />

levonorgestrelu.<br />

Gedeon Richter Ltd. 31/03/04<br />

Film-coated tablets Novo Nordisk A/S 31/01/05<br />

Film-coated tablets Novo Nordisk A/S 31/01/05


EN<br />

1328 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13495 Trisiston Ethinylestradiolum +<br />

Levonorgestrelum<br />

13496 Trisulfan — Vet Sulphadiazinum +<br />

Trimethoprimum<br />

13497 Trisulmix Trimethoprium +<br />

Sulphadiazinum<br />

Coated tablets Jenapharm GmbH & Co. 30/04/04<br />

Solution for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Vetem 20/10/05<br />

Virbac 21/03/05<br />

13498 Tritace 1,25 Ramiprilum Capsules 1.25 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

13499 Tritace 1,25 Ramiprilum Tablets 1.25 mg Aventis Pharma Deutschland<br />

GmbH<br />

13500 Tritace 10 Ramiprilum Tablets 10 mg Aventis Pharma Deutschland<br />

GmbH<br />

13501 Tritace 2,5 Ramiprilum Capsules 2.5 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

13502 Tritace 2,5 Ramiprilum Tablets 2.5 mg Aventis Pharma Deutschland<br />

GmbH<br />

13503 Tritace 2,5 comb Hydrochlorothiazidum +<br />

Ramiprilum<br />

Tablets 12,5mg +<br />

2,5mg<br />

Hoechst Marion Roussel<br />

Deutschland GmbH<br />

13504 Tritace 5 Ramiprilum Capsules 5 mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

13505 Tritace 5 Ramiprilum Tablets 5 mg Aventis Pharma Deutschland<br />

GmbH<br />

13506 Tritace 5 comb Hydrochlorothiazidum +<br />

Ramiprilum<br />

13507 Tritanrix HB Diphtheria-hepatitis Bpertussis-tetanus<br />

13508 Trittico CR Trazodoni<br />

hydrochloridum<br />

13509 Trittico CR Trazodoni<br />

hydrochloridum<br />

13510 Trivacton 6 Inaktywowana<br />

szczepionka dla bydła<br />

przeciwko biegunkom<br />

nowonarodzonych<br />

ciela˛t wywołanych<br />

przez Escherichia coli,<br />

rotawirusy,<br />

koronawirusy<br />

13511 Trivermix Prazikwantel, pyrantel,<br />

oksantel<br />

13512 Trivirovax Szczepionka<br />

przeciwko nosówce,<br />

zakaz´nemu zapaleniu<br />

wa˛troby, zakaz´nemu<br />

zapaleniu górnych<br />

dróg oddechowych i<br />

parwowirozie dla<br />

psów<br />

13513 Trizivir Abacavirum +<br />

lamivudinum +<br />

Zidovudinum<br />

Tablets 25mg + 5mg Hoechst Marion Roussel<br />

Deutschland GmbH<br />

Suspension for<br />

intramuscular<br />

injection<br />

Prolonged release<br />

tablets<br />

Prolonged release<br />

tablets<br />

Suspension for veterinary<br />

use<br />

Tablets for veterinary<br />

use<br />

Lyophilisate + solvent for veterinary<br />

use<br />

Film-coated tablets 300mg +<br />

150mg +<br />

300mg<br />

0.5 ml SmithKline Beecham<br />

Biologicals<br />

150 mg Aziende Chimiche Riunite<br />

Angelini Francesco<br />

75 mg Aziende Chimiche Riunite<br />

Angelini Francesco<br />

30/11/04<br />

31/03/05<br />

6/12/06<br />

30/11/04<br />

31/03/05<br />

24/05/06<br />

30/11/04<br />

31/03/05<br />

24/05/06<br />

31/12/08<br />

29/11/06<br />

29/11/06<br />

Merial SAS 25/03/07<br />

Biowet Puławy 31/12/08<br />

Merial 14/06/04<br />

GlaxoWellcome Group 27/06/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1329<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13514 Trobicin Spectinomycinum Powder and solvent<br />

for solution for<br />

injection<br />

2 g Pharmacia & Upjohn Co. 31/07/04<br />

13515 Trojanka Preparat ziołowy Oral solution UAB Pharmacos 5/07/06<br />

13516 Trollvita Buccal tablet Manhattan Drug Co. Inc. 31/12/08<br />

13517 Trombina 400 Thrombinum Lyophilisate and<br />

solvent for solution<br />

for local use<br />

13518 Trombina 5000 Thrombinum Lyophilisate for<br />

solution for local use<br />

13519 Trombocid Sól sodowa polisiarczanu<br />

pentozanu<br />

Gel 1,5 g/100 g<br />

(1,5 %)<br />

13520 Troparin Certoparinum Solution for<br />

subcutanous injection<br />

13521 Troparin Certoparinum Solution for<br />

subcutanous injection<br />

400 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

5000 j.m. Biomed Wytwórnia Surowic i<br />

Szczepionek Sp. z o.o. —<br />

Lublin<br />

32 mg/0,3 ml<br />

(3000 j.m.<br />

anty-Xa)<br />

32 mg/0,5 ml<br />

(3000 j.m.<br />

anty-Xa)<br />

30/10/05<br />

30/10/05<br />

Bene — Arzneimittel GmbH 31/12/08<br />

Biochemie GmbH Kundl 24/08/05<br />

Biochemie GmbH Kundl 24/08/05<br />

13522 Tropicamidum 0,5 % Tropicamidum Eye drops, solution 5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

13523 Tropicamidum 1 % Tropicamidum Eye drops, solution 10 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

13524 Trovan Alatrofloxacinum Concantrate for<br />

solution for<br />

intravenous infusion<br />

5 mg/1ml Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

13525 Trovan Trovafloxacinum Film-coated tablets 100 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

13526 Trovan Trovafloxacinum Film-coated tablets 200 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

30/11/05<br />

30/11/05<br />

31/05/04<br />

31/05/04<br />

31/05/04<br />

13527 Troxeratio 300 Troxerutinum Capsules 0.3 g ratiopharm GmbH 30/04/04<br />

13528 Troxerutin Troxerutinum Capsules 200 mg Przedsie˛biorstwo<br />

Farmaceutyczno —<br />

Chemiczne ‘Synteza’ Sp. z<br />

o.o.<br />

13529 Troxerutin Troxerutinum Gel 20 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

13530 Troxescorbin Acidum ascorbicum +<br />

Troxerutinum<br />

Capsules 200mg +<br />

50mg<br />

Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

30/09/07<br />

23/11/05<br />

31/12/07<br />

13531 Troxevasin Troxerutinum Capsules 300 mg Pharmachim-Holding AD 31/07/04<br />

13532 Troxevasin Troxerutinum Gel 20 mg/g Pharmachim-Holding AD 31/07/04<br />

13533 Tru Alo Aloe Vera Drinking<br />

Gel 85 %<br />

13534 Tru Alo Aloe Vera Drinking<br />

Gel 90 %<br />

13535 Tru Alo Aloe Vera Drinking<br />

Gel 99 %<br />

Oral solution Hi Tech Aloe Vera 31/12/07<br />

Oral solution Hi Tech Aloe Vera 31/12/07<br />

Oral solution Hi Tech Aloe Vera 31/12/07


EN<br />

1330 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13536 Trusopt Dorzolamidum Eye drops, solution 20 mg/ml Merck Sharp & Dohme Idea<br />

Inc.<br />

13537 Trypaflawina Trypaflawiny chlorek Solution for veterinary<br />

use<br />

13538 Trypaflawina Forte Akrylawiny chlorek Solution for veterinary<br />

use<br />

13539 TS-11 Z˙ywa szczepionka<br />

przeciw zakaz˙eniom<br />

Mycoplasma<br />

gallisepticum dla kur<br />

13540 T-Szczepionka te˛z˙cowa<br />

adsorbowana na wodortlenku<br />

glinu<br />

13541 Tuberculin PPD RT23 SSI (do<br />

stosowania w próbie Mantoux)<br />

Tetanus toxoid Suspension for<br />

subcutaneous<br />

injection<br />

Liquid for veterinary<br />

use<br />

nie mniej niz˙<br />

40 j.m.<br />

toksoidu<br />

te˛z˙cowego<br />

(1 dawka —<br />

0,5ml)<br />

Solution for injection 2 T.U./dawke˛<br />

0,1 ml<br />

15/03/06<br />

Przedsie˛biorstwo Tropical 31/12/08<br />

Przedsie˛biorstwo Tropical 18/09/07<br />

Merial SAS 2/01/06<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

31/12/08<br />

Statens Serum Institut 30/06/07<br />

13542 Tubocurarin Tubocurarinum Solution for injection 10 mg/ml Orion Corporation 31/07/04<br />

13543 Tucoprim 150 Sulphadiazinum +<br />

Trimethoprimum<br />

Premix for veterinary<br />

use<br />

Pharmacia & Pharmacia<br />

N.V./S.A.<br />

21/02/06<br />

13544 Tulip Atorvastatinum Film-coated tablets 10 mg Lek Pharmaceutical d.d. 31/12/08<br />

13545 Tulip Atorvastatinum Film-coated tablets 20 mg Lek Pharmaceutical d.d. 31/12/08<br />

13546 Tums Calcii carbonas +<br />

Magnesii carbonas<br />

13547 Tums Calcii carbonas +<br />

Magnesii carbonas<br />

13548 TUR-3 Szczepionka dla<br />

indyków przeciw<br />

rzekomemu pomorowi<br />

drobiu,<br />

paramyksowirusowi<br />

typ 3, zapaleniu nosa i<br />

tchawicy<br />

Buccal tablet 600mg +<br />

125mg<br />

SmithKline Beecham<br />

Consumer Healthcare<br />

31/12/07<br />

Tablets SmithKline Beecham 31/12/07<br />

Emulsion for veterinary<br />

use<br />

Merial 19/07/05<br />

13549 Turinal Allylestrenolum Tablets 5 mg Gedeon Richter Ltd. 31/05/04<br />

13550 Turineurin Hyperici herbae<br />

extractum siccum<br />

Capsules Jenapharm GmbH & Co. 31/12/08<br />

13551 Turiplex Capsules 122.5 mg Jenapharm GmbH & Co. 31/12/08<br />

13552 Tussal Antitussicum, Tussal Dextromethorphanum Film-coated tablets 15 mg P.P.H.U. Biofarm Sp. z o.o. 31/05/05<br />

13553 Tussal Expectorans, Mucoren Ambroxolum Tablets 30 mg P.P.H.U. Biofarm Sp. z o.o. 31/07/05<br />

13554 Tussicom 100 Acetylcysteinum Granules 100 mg/5g Sanofi-Synthelabo Sp. z o.o. 30/10/05<br />

13555 Tussicom 200 Acetylcysteinum Granules 200 mg/5 g Sanofi-Synthelabo Sp. z o.o. 30/10/05<br />

13556 Tussicom 400 Acetylcysteinum Granules 400 mg/5 g Sanofi-Synthelabo Sp. z o.o. 30/11/05<br />

13557 Tussicom 600 Acetylcysteinum Granules 600 mg/5 g Sanofi-Synthelabo Sp. z o.o. 31/07/05<br />

13558 Tussidex Dextromethorphanum Capsules, soft 30 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

6/06/07<br />

13559 Tussidrill Dextromethorphanum Syrup 5 mg/5 ml Pierre Fabre Sante 15/11/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1331<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13560 Tussiflos Herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

13561 Tussipect Preparat złoz˙ony Coated tablets Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

13562 Tussipect Preparat złoz˙ony Syrup Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

13563 Tussiten — fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp.<br />

z o.o. — Zastawna<br />

13564 Twinrix Junior Suspension for<br />

intramuscular<br />

injection<br />

13565 Twinrix Adult Suspension for<br />

intramuscular<br />

injection<br />

13566 TwoCal HN (o smaku<br />

orzechowym)<br />

13567 TwoCal HN (o smaku<br />

waniliowym)<br />

13568 Two-Septol Sulfamethoxazolum +<br />

Trimethoprimum<br />

0.5 ml<br />

(1 dawka)<br />

SmithKline Beecham<br />

Biologicals<br />

1 ml (1 dawka) SmithKline Beecham<br />

Biologicals<br />

Preparat odz˙ywczy Oral solution Ross Products Division-<br />

Abbott Laboratories<br />

Preparat odz˙ywczy Oral solution Ross Products Division-<br />

Abbott Laboratories<br />

13569 Tylan 200 Injection Tylozyna Solution for veterinary<br />

use<br />

13570 Tylan 50 Injection Tylozyna Solution for veterinary<br />

use<br />

13571 Tylan G 100 Premix Tylozyny fosforan Premix for veterinary<br />

use<br />

13572 Tylan Soluble Powder Tylozyny winian Powder for veterinary<br />

use<br />

13573 TYLASUL G 100 Premix Tylozyny fosforan,<br />

Sulfametazyna<br />

13574 Tylbiacol Tylozyny winian,<br />

Kolistyny siarczan<br />

31/12/07<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

31/12/08<br />

31/12/08<br />

25/05/05<br />

25/05/05<br />

Tablets 480 mg Cyntfarm Sp. z o.o. 29/06/05<br />

Premix for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

13575 Tylbian Tylozyny winian Granules for veterinary<br />

use<br />

13576 Tylbian 20 % Injectio Tylozyny winian Liquid for veterinary<br />

use<br />

Elanco Animal Health 11/03/04<br />

Elanco Animal Health 11/03/04<br />

Elanco Animal Health 11/03/04<br />

Elanco Animal Health 11/03/04<br />

Elanco Animal Health 11/03/04<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Zakłady farmaceutyczne<br />

Biowet Sp. z o.o.<br />

25/05/04<br />

30/06/04<br />

10/06/04<br />

13577 Tylenol forte Paracetamolum Tablets 500mg Cilag AG 31/07/04<br />

13578 Tylosin 20 % Tylozyny winian Solution for veterinary<br />

use<br />

13579 Tylosin 5 % Tylozyny winian Solution for veterinary<br />

use<br />

13580 Tylosineject 20 % Tylozyny winian Suspension for veterinary<br />

use<br />

13581 Tylosulfan Tylozyny winian,<br />

Sulfadimidyna sodowa<br />

Powder for veterinary<br />

use<br />

13582 Tylovet 20 % Tylozyny winian Solution for veterinary<br />

use<br />

Bela-Pharm 31/12/08<br />

Bela-Pharm 31/12/08<br />

Dopharma B.V. 27/02/06<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego S.A.<br />

6/12/04<br />

Alfasan 18/03/04


EN<br />

1332 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13583 Tylovet L.A. Tylozyna Suspension for veterinary<br />

use<br />

Norbrook Laboratories Ltd. 29/08/06<br />

13584 Tymianek i Podbiał Preparat ziołowy Buccal tablets GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

30/10/05<br />

13585 Tymol A.C.E.F., Włochy 31/12/08<br />

13586 Tymol Chema Elektromet, Rzeszów 31/12/08<br />

13587 Tymol Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

13588 Tymol Margo Corporation,<br />

Warszawa<br />

31/12/08<br />

31/12/08<br />

13589 Tymol Pharma Cosmetic, Kraków 31/12/08<br />

13590 Tymol PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

13591 Tympachol Z˙ółć bydle˛ca,<br />

Formaldehyd, Etanol<br />

Liquid for veterinary<br />

use<br />

13592 Tympasil Simethiconum Emulsion for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet Sp. z o.o.<br />

31/12/08<br />

10/06/04<br />

Biowet Puławy 31/12/08<br />

13593 Tymsal spray Preparat ziołowy Oromucosal spray Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

13594 Typhim Vi Vaccinum febris<br />

typhoidis<br />

polysaccharidicum<br />

13595 Typhim Vi Vaccinum febris<br />

typhoidis<br />

polysaccharidicum<br />

Solution for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

Solution for<br />

intramuscular or<br />

subcutaneous<br />

injection<br />

31/12/04<br />

1 dawka Aventis Pasteur S.A. 7/03/07<br />

20 dawek Aventis Pasteur S.A. 7/03/07<br />

13596 Tyrocil Propylthiouracilum Tablets 50 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

13597 Ty-Szczepionka durowa Typhoid, inactivated,<br />

whole cell<br />

Suspension for<br />

subcutaneous<br />

injection<br />

500 mln<br />

komórek,<br />

(1 dawka —<br />

0,5ml)<br />

Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

31/12/08<br />

30/10/05<br />

13599 Tytanoreina Cream Johnson & Johnson/Martin 31/12/08<br />

13598 Tytanoreina Suppository Johnson & Johnson/Martin 31/12/08<br />

13600 TyT-Szczepionka durowote˛z˙cowa<br />

Vaccinum febris typhoidi<br />

et tetani<br />

Suspension for<br />

subcutaneous<br />

injection<br />

20 dawek Wytwórnia Surowic i<br />

Szczepionek Biomed —<br />

Kraków<br />

13601 Tyzine Tetryzolinum Nasal drops, solution 0.5 mg/ml Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

13602 Tyzine Tetryzolinum Nasal drops, solution 1 mg/ml Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

30/10/05<br />

30/04/04<br />

30/04/04<br />

13603 Ubichinon Compositum Amp. Heel GmbH 31/12/08<br />

13604 UbiMax Q-10 Ubidecarenonum Tablets 30 mg VITABALANS Oy 10/05/06<br />

13605 Ubistesin Articainum +<br />

Epinephrinum<br />

Solution for injection ESPE Dental AG 31/03/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1333<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13606 Ubistesin Forte Articainum +<br />

Epinephrinum<br />

Solution for injection ESPE Dental AG 31/03/05<br />

13607 Ubretid Distigmini bromidum Solution for injection 0.5 mg/1 ml Nycomed Austria GmbH 31/07/04<br />

13608 Ubretid Distigmini bromidum Solution for injection 1 mg/1 ml Nycomed Austria GmbH 31/07/04<br />

13609 Ubretid Distigmini bromidum Tablets 5 mg Nycomed Austria GmbH 31/07/04<br />

13610 Uczucie zme˛czenia i obrze˛ku<br />

nóg HomeoPorady<br />

13611 UFT Tegafurum + Uracilum Capsules 100mg +<br />

224mg<br />

13612 Uka˛szenia owadów<br />

HomeoPorady<br />

Laboratoires BOIRON 4/07/07<br />

TAIHO Pharmaceutical Co,<br />

Ltd.<br />

31/05/05<br />

Laboratoires BOIRON 30/06/07<br />

13613 Ulceflos fix Herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

13614 Ulceran 250 Mesalazinum Gastro-resistant<br />

tablets<br />

13615 Ulceran 500 Mesalazinum Gastro-resistant<br />

tablets<br />

250 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

500 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

13616 Ulcetal Hydrotalcitum Buccal tablet 500 mg Zakłady Farmaceutyczne<br />

Colfarm<br />

13617 Ulcogant Sucralfatum Granules for oral<br />

suspension<br />

31/12/07<br />

31/12/08<br />

31/12/08<br />

12/08/06<br />

1 g Merck KGaA 31/07/04<br />

13619 Ulcogant Sucralfatum Oral suspension 1 g/5 ml Merck KGaA 31/07/04<br />

13618 Ulcogant Sucralfatum Tablets 1 g Merck KGaA 31/07/04<br />

13620 Uldenol Coated tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

30/10/05<br />

13623 Ulfamid Famotidinum Film-coated tablets 40 mg KRKA Polska Sp. z o.o. 31/01/06<br />

13624 ULFAMID Famotidinum Film-coated tablets 20 mg KRKA Polska Sp. z o.o. 31/12/08<br />

13621 Ulfamid Famotidinum Tablets 20 mg Krka d.d., Novo mesto 31/07/04<br />

13622 Ulfamid Famotidinum Tablets 40 mg Krka d.d., Novo mesto 31/07/04<br />

13625 Ulgamax Calcii carbonas +<br />

Dimeticonum +<br />

Magnesii carbonas<br />

Buccal tablet 700mg +<br />

20mg +<br />

100mg<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

13627 Ulgastran Sucralfatum Oral suspension 1 g/5 ml Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

13626 Ulgastran Sucralfatum Tablets 1 g Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

13628 Ulgix Magnesii carbonas +<br />

Calcii carbonas +<br />

Simethiconum<br />

Buccal tablets Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

26/04/06<br />

31/01/06<br />

31/01/06<br />

31/12/08<br />

13629 Ulran Ranitidinum Film-coated tablets 150 mg Krka d.d., Novo mesto 9/08/06<br />

13630 Ulran Ranitidinum Film-coated tablets 300 mg Krka d.d., Novo mesto 9/08/06<br />

13631 Ultiva Remifentanilum Lyophilisate for<br />

solution for injection<br />

and intravenous<br />

infusion<br />

1 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/12/04


EN<br />

1334 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13632 Ultiva Remifentanilum Lyophilisate for<br />

solution for injection<br />

and intravenous<br />

infusion<br />

13633 Ultiva Remifentanilum Lyophilisate for<br />

solution for injection<br />

and intravenous<br />

infusion<br />

13634 Ultra Tag Rbc Preparat<br />

radiofarmaceutyczny<br />

13635 Ultra Technekow FM Preparat<br />

radiofarmaceutyczny<br />

13636 Ultracain D-S Articainum +<br />

Epinephrinum<br />

13637 Ultracain D-S Articainum +<br />

Epinephrinum<br />

13638 Ultracain D-S forte Articainum +<br />

Epinephrinum<br />

13639 Ultratard HM Insulini cum Zinco<br />

suspensio<br />

13640 Ultratard HM Insulini cum Zinco<br />

suspensio<br />

Solution for injection (40 mg +<br />

6mcg)/ml<br />

Solution for injection (40mg +<br />

6mcg)/ml<br />

Solution for injection (40mg +<br />

12mcg)/ml<br />

Suspension for<br />

injection<br />

Suspension for<br />

injection<br />

2 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

5 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/12/04<br />

31/12/04<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Mallinckrodt Medical B.V. 31/12/08<br />

Hoechst Marion Roussel<br />

Deutschland GmbH<br />

Hoechst Marion Roussel<br />

Deutschland GmbH<br />

Hoechst Marion Roussel<br />

Deutschland GmbH<br />

30/06/04<br />

29/01/06<br />

30/06/04<br />

100 j.m./ml Novo Nordisk A/S 10/05/06<br />

40 j.m./ml Novo Nordisk A/S 10/05/06<br />

13641 Ultravist 240 Iopromidum Solution for injection 498.72 mg/ml Schering AG 31/07/04<br />

13642 Ultravist 300 Iopromidum Solution for injection 623.4 mg/ml Schering AG 31/07/04<br />

13643 Ultravist 370 Iopromidum Solution for injection 768.86 mg/ml Schering AG 31/07/04<br />

13644 Ulvenduosan Mieszanka ziołowa Herbal tea Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

13645 Ulventrol Coated tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

13646 Ulventroten fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp.<br />

z o.o. — Zastawna<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

13647 Ulvesol-eldex Herbal tea Eldex Medical 31/12/08<br />

13648 Ulvesolen-fix Instant herbal tea P.P.H. ‘Eldex-Medical’, Wiry 31/12/08<br />

13649 Ulzol Omeprazolum Capsules 20 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

13650 Uman Albumin 20 % Albuminum humanum Solution for<br />

intravenous infusion<br />

13651 Uman Albumin 5 % Albuminum humanum Solution for<br />

intravenous infusion<br />

13652 Unasyn Ampicillinum +<br />

Sulbactamum<br />

13653 Unasyn Ampicillinum +<br />

Sulbactamum<br />

13654 Unasyn Ampicillinum +<br />

Sulbactamum<br />

Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

Powder for solution<br />

for intramuscular and<br />

intravenous injection<br />

butelka a'<br />

50 ml<br />

butelka a'<br />

250 ml<br />

24/05/06<br />

Farma Biagini S.p.A. 31/12/08<br />

Farma Biagini S.p.A. 31/12/08<br />

1g + 500mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

2g + 1g Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

500mg +<br />

250mg<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

30/10/05<br />

30/10/05<br />

30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1335<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13655 Unasyn Ampicillinum +<br />

Sulbactamum<br />

13656 Unasyn Ampicillinum +<br />

Sulbactamum<br />

13657 Unasyn Ampicillinum +<br />

Sulbactamum<br />

Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

Powder for solution<br />

for intravascular,<br />

intramuscular<br />

injection and infusion<br />

0.75 g Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

1.5 g Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

3 g Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

13659 Unasyn Sultamicillinum Film-coated tablets 375 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

13658 Unasyn Sultamicillinum Powder for oral<br />

suspension<br />

250 mg/5ml Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

13660 Unat 10 Torasemidum Solution for injection 10 mg/2 ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

13661 Unat 10 Torasemidum Tablets 10 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

13662 Unat 20 Torasemidum Solution for injection 20 mg/4 ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

13663 Unat 200 Torasemidum Solution for injection 200 mg/20 ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

13664 Unat 200 Torasemidum Tablets 0.2 g Hoffmann La Roche Ltd.<br />

Bazylea<br />

13665 Unat 5 Torasemidum Tablets 5 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

13666 Undestor Testosteronum Capsules 40 mg Organon N.V. —<br />

Kloosterstraat<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

30/06/04<br />

13667 UNDEVIT — Multivitamin Preparat witaminowy KYIV VITAMIN FACTORY Co 31/12/08<br />

13668 Undofen atomizer Acidum undecylenicum +<br />

Cetylpyridinium<br />

13669 Unguentum acidi borici —<br />

mas´ć borna<br />

13670 Unguentum Acidi borici cum<br />

Mentholo<br />

13671 Unguentum Ammonii<br />

sulfobitumici<br />

13672 Unguentum Ammonii<br />

Sulfobituminici<br />

Spray GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Acidum boricum Ointment 3 % Coel s.c.- Laboratorium<br />

Farmaceutyczne Wytwórnia<br />

Euceryny<br />

Acidum boricum +<br />

Mentholum<br />

Sulfobituminian<br />

amonowy<br />

Ointment (40mg +<br />

10mg)/g<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

30/09/05<br />

31/12/08<br />

30/06/04<br />

Ointment Farmina Sp. z o.o. 31/12/04<br />

Ointment for veterinary<br />

use<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

13/10/04<br />

13673 Unguentum camphoratum Camphorum Ointment Farmina Sp. z o.o. 31/12/04<br />

13674 Unguentum Camphoratum Camphorum Ointment for veterinary<br />

use<br />

13675 Unguentum contra<br />

congelationem<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

11/02/06<br />

Ointment Farmina Sp. z o.o. 31/12/04


EN<br />

1336 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13676 Unguentum Iodo-<br />

Camphoratum<br />

Kalii iodum + Iodum +<br />

Camphorum<br />

Ointment for veterinary<br />

use<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

13677 Unguentum maioranae Ointment CYNTFARM Sp. z o.o.,<br />

Pruszków<br />

13678 Unguentum Majoranae —<br />

Mas´ć majerankowa<br />

10/02/04<br />

31/12/08<br />

Ointment Farmina Sp. z o.o. 31/12/04<br />

13679 Unguentum Neomycini Neomycinum Ointment 5 mg/g Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

13680 Unguentum Olei Jecoris Aselli Tran Ointment for veterinary<br />

use<br />

13681 Unguentum undecylenicum Acidum undecylenicum +<br />

Zinci undecylenas<br />

Ointment (50mg +<br />

200mg)/g<br />

13682 Unguentum Zinci Oxydati Zinci oxydum Ointment for veterinary<br />

use<br />

13683 Unguentum Zinci salicylatum<br />

— Pasta Lassara<br />

Acidum salicylicum +<br />

Zinci oxydum<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego Spółka<br />

Akcyjna<br />

Chema Elektromet<br />

Spółdzielnia Pracy-<br />

Przemysłowa<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

30/09/05<br />

14/02/05<br />

31/01/06<br />

30/06/04<br />

Ointment Farmina Sp. z o.o. 31/12/04<br />

13684 Unibasis Cutaneous emulsion Pampa — Laboratorium<br />

Farmaceutyczno-Kosmetyczne<br />

30/06/05<br />

13685 Unicap Jr Buccal tablet Pharmacia & Upjohn Co. 30/06/04<br />

13686 Unicap M Tablets Pharmacia & Upjohn Ltd. 30/06/04<br />

13687 Unicap T Tablets Pharmacia & Upjohn Ltd. 30/06/04<br />

13688 Unidox Solutab Doxycyclinum Tablets 100 mg Yamanouchi Europe B.V. 31/12/08<br />

13689 Uni-Dur Theophyllinum Prolonged release<br />

tablets<br />

13690 Uni-Dur Theophyllinum Prolonged release<br />

tablets<br />

400 mg Schering-Plough Labo N.V. 31/08/04<br />

600 mg Schering-Plough Labo N.V. 31/08/04<br />

13691 Unifungicid Chlormidazolum Ointment 50 mg/g Unia Zakłady<br />

Farmaceutyczno-Aerozolowe<br />

Spółdzielnia Pracy<br />

13692 Unilar Theophylinum Prolonged release<br />

capsules<br />

13693 Unilar Theophylinum Prolonged release<br />

capsules<br />

13694 Unilar Theophylinum Prolonged release<br />

capsules<br />

31/01/06<br />

200 mg 3 M MEDICA 31/12/08<br />

300 mg 3 M MEDICA 31/12/08<br />

450 mg 3 M MEDICA 31/12/08<br />

13695 Unipres Nitrendipinum Tablets 10 mg Krka d.d., Novo mesto 31/12/04<br />

13696 Unipres Nitrendipinum Tablets 20 mg Krka d.d., Novo mesto 30/01/05<br />

13697 Uprima Apomorphini<br />

hydrochloridum<br />

13698 Uprima Apomorphini<br />

hydrochloridum<br />

Sublingual tablets 2 mg Abbott Laboratories Ltd. 14/02/07<br />

Sublingual tablets 3 mg Abbott Laboratories Ltd. 14/02/07<br />

13699 Upsarin 325 Acidum acetylsalicylicum Effervescent tablets 325 mg UPSA Laboratoires Agen 31/03/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1337<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13700 Upsarin 500 Acidum acetylsalicylicum Effervescent tablets 500 mg UPSA Laboratoires Agen 31/03/07<br />

13701 Upsarin C Acidum acetylsalicylicum<br />

+ Acidum ascorbicum<br />

(vit C)<br />

Effervescent tablets UPSA Laboratoires Agen 30/06/04<br />

13702 Upsavit Calcium Calcii carbonas Effervescent tablets 500 mg Pharmavit Rt a Bristol —<br />

Myers Squibb Co.<br />

31/12/08<br />

13703 Upsavit Multivitamins Buccal tablet UPSA Laboratoires Agen 30/09/05<br />

13704 Upsavit Multivitamins Effervescent tablets UPSA Laboratoires Agen 30/09/05<br />

13706 Upsavit Vitamin C Acidum ascorbicum<br />

(vit C)<br />

13705 Upsavit Vitamin C Acidum ascorbicum<br />

(vit C)<br />

Buccal tablet 500 mg UPSA Laboratoires Agen 31/07/04<br />

powder for solution 1000 mg UPSA Laboratoires Agen 31/07/04<br />

13707 Urandil Chlortalidonum Tablets 50 mg Lečiva a.s. 31/07/04<br />

13708 Urarthone Drops Lehning Laboratoires 31/12/08<br />

13709 Urazy w sporcie HomeoPorady Laboratoires BOIRON 4/07/07<br />

13710 Urenil Sulfacarbamidum Tablets 0.5 g Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

13711 Uresatin(poprzednia nazwa<br />

uresan)<br />

30/10/05<br />

Tablets Vitabalans Oy 31/12/08<br />

13712 Urgo Cor Dressing Acidum salicylicum Pach 400 mg/g Urgo Laboratoires S.A. 30/01/05<br />

13713 Urispas Flavoxatum Film-coated tablets 200 mg Recordati S.p.A. 31/12/08<br />

13714 Uristan Oxybutyninum Tablets 5 mg Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

13715 Urkam Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’<br />

13716 Urkam Warszawskie Zakłady<br />

Zielarskie ‘Herbapol’<br />

13717 Urocalcit Kalii citras Oral solution 10 mEq/5 ml Management & Consulting<br />

Group<br />

13718 Uroderm Urea Cream 100 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

13719 Uroderm H Krem Hydrocortisonum + Urea Cream 10 mg, 100 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

23/11/05<br />

31/12/08<br />

13720 Urofort Oral solution Dar Natury P.P.H. 6/06/07<br />

13721 Urografin 60 % Solution for<br />

intravenous infusion<br />

13722 Urografin 76 % Solution for<br />

intravenous infusion<br />

600 mg/g Schering AG 30/04/04<br />

760 mg/g Schering AG 30/04/04<br />

13723 Urogran Herbal granules Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

13724 Urokinaza Urokinasum Powder for solution<br />

for intravenous or<br />

intra-arterial infusion<br />

13725 Urokinaza Urokinasum Powder for solution<br />

for intravenous or<br />

intra-arterial infusion<br />

30/10/05<br />

250000 j.m. K and K medicplast 27/09/06<br />

500000 j.m. K and K medicplast 27/09/06


EN<br />

1338 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13726 Urolin Acidum pipemidicum Capsules 200 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

13727 Urolitum Acidum citricum +<br />

Natrii citras + Kalii<br />

hydrocarbonas<br />

Effervescent tablets 1197 mg +<br />

835,5 mg +<br />

967,5 mg<br />

30/01/05<br />

Labpharm Sp. z o.o. 31/12/08<br />

13728 Uromiro 60 % Acidum amidotrizoicum Solution for injection 477 mg /1 ml Bracco S.p.A. 6/07/05<br />

13729 Uromiro 75 % Acidum amidotrizoicum Solution for injection 596 mg /1 ml Bracco S.p.A. 6/07/05<br />

13732 Uromitexan Mesnum Film-coated tablets 400 mg Asta Medica AG 31/12/08<br />

13733 Uromitexan Mesnum Film-coated tablets 600 mg Asta Medica AG 31/12/08<br />

13730 Uromitexan Mesnum Solution for injection ASTA Medica AG 31/07/04<br />

13731 Uromitexan Mesnum Solution for injection 100 mg/ml Asta Medica AG 31/07/04<br />

13734 Uromix Betulae folium +<br />

Orthosiphonis folium +<br />

Solidaginis herba<br />

Capsuels, hard 100mg +<br />

200mg +<br />

200mg<br />

Agropharm S.A. 16/05/07<br />

13735 Uromix Herbal tea Herba Oskar, Wierzbówiec 16/05/07<br />

13736 Uropatina Herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

13737 Uropatina Instant herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

13738 Uropolinum 60 % Natrii amidotrizoas Solution for injection<br />

or intravenous<br />

infusion<br />

13739 Uropolinum 75 % Natrii amidotrizoas Solution for injection<br />

or intravenous<br />

infusion<br />

600 mg/g Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

750 mg/g Polpharma S.A. Starogardzkie<br />

Zakłady Farmaceutyczne<br />

13740 Uroprost Preparat ziołowy Liquid Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

13741 Urosal Methenaminum +<br />

Phenyli salicylas<br />

Tablets 300mg +<br />

300mg<br />

VIS — Zakłady Chemiczno-<br />

Farmaceutyczne Sp. z o.o.<br />

30/10/05<br />

30/10/05<br />

31/01/06<br />

31/01/06<br />

30/10/05<br />

31/12/05<br />

13742 Urosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

13743 Urosan fix Mieszanka ziołowa Instant herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

13744 Urosept Preparat złoz˙ony Coated tablets Herbapol — Poznańskie<br />

Zakłady Zielarskie S.A.<br />

13745 Urosolid Solidaginis extractum<br />

fluidum<br />

30/10/05<br />

Oral solution Phytopharm Kle˛ka S.A. 31/05/06<br />

13746 Uroton Oxybutyninum Film-coated tablets 5 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

13747 Urotrim Trimethoprimum Film-coated tablets 100 mg Medana Pharma Terpol<br />

Group S.A.<br />

13748 Urotrim Trimethoprimum Film-coated tablets 200 mg Medana Pharma Terpol<br />

Group S.A.<br />

13749 Urotrim Trimethoprimum Oral suspension 50 mg/ 5 ml Medana Pharma Terpol<br />

Group S.A.<br />

13750 Uro-Vaxom Antiinfectives,<br />

combinations<br />

Capsules 6 mg OM Pharma (dawniej<br />

Laboratories OM)<br />

13751 Urovit Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

31/12/08<br />

12/10/05<br />

12/10/05<br />

12/10/05<br />

30/04/04<br />

30/10/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1339<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13752 Urovit Instant herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

31/03/07<br />

13753 Urovit Capsules Bional Pharma BV 31/12/08<br />

13754 Uroz˙el Gel for urethral<br />

anaesthesia<br />

13755 Ursocam Acidum<br />

ursodeoxycholicum<br />

13756 Ursofalk Acidum<br />

ursodeoxycholicum<br />

13757 Ursopol Acidum<br />

ursodeoxycholicum<br />

13758 Ursopol Acidum<br />

ursodeoxycholicum<br />

200 mg<br />

lidokainy HCl ;<br />

5mg<br />

diglukonianu<br />

chlorheksydyny<br />

/ 10 g<br />

Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

31/12/08<br />

Tablets 250 mg Polfarmex S.A 31/12/05<br />

Capsules 250 mg Dr Falk Pharma GmbH 27/11/06<br />

Capsules 150 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

Capsules 300 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

13759 Urtica comp. granulki WALA-Heilmittel GmbH 31/08/05<br />

13760 Urtica comp. inj. WALA-Heilmittel GmbH 31/08/05<br />

13761 Urtica fix Herb Herbapol Lublin S.A. 30/10/05<br />

13762 Urtiron Sitosterolum + Urticae<br />

radix extractum<br />

Capsules 0.3 g Krka d.d., Novo mesto 31/12/07<br />

13763 Urtix Urticae radix Tablets 330 mg Labofarm — Innowacyjno-<br />

Wdroz˙eniowe Laboratorium<br />

Farmaceutyczne<br />

13764 Uterotonic Propranololu<br />

chlorowodorek<br />

13765 Uterovet 2 Propranololu<br />

chlorowodorek,<br />

Cymetydyna,<br />

Chlorheksydyny<br />

chlorowodorek<br />

Solution for veterinary<br />

use<br />

Powder for veterinary<br />

use<br />

13766 Utersol PVP-Iodine Foam for veterinary<br />

use<br />

Warszawskie Zakłady<br />

Farmaceutyczne Polfa<br />

25/10/06<br />

21/05/04<br />

Interbiowet 31/12/08<br />

Biowet Drwalew 31/12/08<br />

13767 Utilin ‘S’ D4 iniekcje Sanum-Kehlbeck 31/12/05<br />

13768 Utilin ‘S’ D4 kaps. Sanum-Kehlbeck 31/12/05<br />

13769 Utilin ‘S’ D6 iniekcje Sanum-Kehlbeck 31/12/05<br />

13770 Utilin ‘S’ D6 kaps. Sanum-Kehlbeck 31/12/05<br />

13771 Utilin D4 iniekcje Sanum-Kehlbeck 31/12/05<br />

13772 Utilin D4 kaps. Sanum-Kehlbeck 31/12/05<br />

13773 Utilin D6 iniekcje Sanum-Kehlbeck 31/12/05<br />

13774 Utilin D6 kaps. Sanum-Kehlbeck 31/12/05<br />

13775 Utrogestan Progesteronum Capsules 100 mg Laboratoires Besins IscoVesco 31/12/08<br />

13776 Uva Ursi Complexe Nr 9 Drops Lehning Laboratoires 31/12/08<br />

13777 Uvacin Tablets Pharbio Medical International<br />

AB<br />

30/09/04


EN<br />

1340 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13778 Uvalette Tablets Pharbio Medical International<br />

AB<br />

13779 Uverex Film-coated tablets 40 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

13780 Uversan Uvae ursi folium<br />

extructum<br />

Film-coated tablets 250 mg Medana Pharma Terpol<br />

Group S.A.<br />

31/01/05<br />

30/10/05<br />

14/12/05<br />

13781 Uzara Coated tablets Stada, Niemcy 31/12/08<br />

13782 Uzara Liquid Stada 31/12/08<br />

13783 V — Superastin Chlorowodorek<br />

chloropyraminy<br />

13784 Vaccin Rabique Inactive Rabies, inactivated,<br />

whole virus<br />

13785 Vaccina L Szczepionka przeciw<br />

rzekomemu pomorowi<br />

drobiu<br />

13786 Vaccina VR2 Szczepionka przeciw<br />

róz˙ycy s´wiń<br />

Tablets 25 µg CYNTFARM Sp. z o.o.,<br />

Pruszków<br />

Lyophilisate and<br />

solvent for solution<br />

for intramuscular<br />

injection<br />

Lyophilisate for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

31/12/08<br />

2.5 j.m./1 ml Aventis Pasteur S.A. 29/02/04<br />

Biowet Puławy 26/04/04<br />

Biowet Puławy 31/12/08<br />

13787 VAGICAL Pessary 1.5 g Farmina Sp. z o.o., Kraków 19/04/07<br />

13788 Vagifem Estradiolum Vaginal tablets 25 mcg Novo Nordisk A/S 21/10/06<br />

13789 Vaginol Herbal tea Eldex-Medical 2/10/06<br />

13790 Vaginol Instant herbal tea Eldex-Medical 2/10/06<br />

13791 Vaginsept Liquid for vaginal<br />

irrigation<br />

Zakłady Farmaceutyczne<br />

POLFA — ŁÓDZ´ S.A.<br />

13792 Vagisan Acidum lacticum Pessary 0,167 g + 0,1 g Dr August Wolff GmbH &<br />

Co. Arzneimittel<br />

13793 Vagoflos Herbal tea Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

13794 Vagolavit Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

13795 Vagolavit Herbal tea Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

31/12/08<br />

31/12/08<br />

30/04/05<br />

31/12/08<br />

30/10/05<br />

13796 Vagosan Mieszanka ziołowa Herbal tea Herbapol Łódz´ S.A. 30/10/05<br />

13797 Vagothyl Policresulenum Solution for external<br />

use<br />

13798 Vagothyl Polikrezulen Concentrate for<br />

infusions<br />

360 mg/g Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

for veterinary<br />

use<br />

13799 Vagothyl 2 % Polikrezulen Liquid for veterinary<br />

use<br />

13800 Vaiol-Vac Z˙ywa szczepionka dla<br />

kur przeciwko ospie<br />

ptaków<br />

Lyophilisate + solvent for veterinary<br />

use<br />

13801 Valbazen 10 % Albendasolum Suspension for veterinary<br />

use<br />

13802 Valbazen 2,5 % Albendasolum Suspension for veterinary<br />

use<br />

Pabianickie Zakłady<br />

Farmaceutyczne Polfa<br />

Pabianickie Zakłady<br />

Farmaceutyczne Polfa<br />

31/12/05<br />

31/12/08<br />

4/08/05<br />

FATRO S.p.A. 19/02/06<br />

Pfizer 22/06/04<br />

Pfizer 22/06/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1341<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13803 Valcyte Valganciclovirum Film-coated tablets 450 mg F. Hoffmann — La Roche<br />

Ltd.<br />

13804 Valdispert Valerianae radix<br />

extractum siccum<br />

13805 Valegran — granulat ziół<br />

uspokajaja˛cych<br />

Coated tablets 45 mg Solvay Pharmaceuticals<br />

GmbH<br />

Preparat złoz˙ony Granules Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

31/12/08<br />

31/01/05<br />

31/12/08<br />

13806 Valerianaheel Drops Heel GmbH 31/12/08<br />

13807 Valerin Valerianae radix<br />

extractum siccum<br />

13809 Validol Mentholum + Menthyli<br />

valeras<br />

13808 Validol Mentholum + Menthyli<br />

valeras<br />

Coated tablets 200 mg AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

28/02/06<br />

Buccal tablet 60 mg Farmak 30/06/04<br />

Oral drops Farmak 30/06/05<br />

13810 Vallup Preparat ziołowy Tablets Herbapol Łódz´ S.A. 31/12/08<br />

13811 Valorum Film-coated tablets Blau Farma Sp. z o.o. Spółka<br />

Komandytowa<br />

13812 Valtrex Valaciclovirum Film-coated tablets 1000 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

13813 Valtrex Valaciclovirum Film-coated tablets 250 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

13814 Valtrex Valaciclovirum Film-coated tablets 500 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

13815 Valupol Valerianae radix<br />

extractum siccum, Lupuli<br />

strobuli extractum siccum<br />

Capsules, hard 100 mg, 50 mg<br />

/300 mg<br />

Poznańskie Zakłady Zielarskie<br />

‘Herbapol’ S.A.<br />

13816 Valused Preparat ziołowy Capsules, soft Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

13817 Valused Preparat ziołowy Oral solution Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

13818 Vamin 14 Electrolyte-Free Solution for<br />

intravenous infusion<br />

13819 Vamin 18 Electrolyte-Free Solution for<br />

intravenous infusion<br />

13820 Vaminolact Solution for<br />

intravenous infusion<br />

26/04/06<br />

31/12/08<br />

31/03/07<br />

31/12/08<br />

31/12/08<br />

15/03/06<br />

31/01/06<br />

Fresenius Kabi AB Uppsala 31/07/04<br />

Fresenius Kabi AB Uppsala 31/07/04<br />

Fresenius Kabi AB Uppsala 7/02/06<br />

13821 Vancocin Vancomycinum Capsules 125 mg Eli Lilly and Company Ltd 31/08/05<br />

13822 Vancocin Vancomycinum Capsules 250 mg Eli Lilly and Company Ltd 31/08/05<br />

13823 Vancocin CP Vancomycinum Lyophilisate for<br />

solution for<br />

intravenous injection<br />

13824 Vancocin CP Vancomycinum Powder for solution<br />

for intravenous<br />

injection<br />

13825 VANCOMYCIN — MIP 1 G Vancomycinum Powder for solution<br />

for intravenous<br />

infusion or for oral<br />

solution<br />

1 g Lilly Pharma Fertigung und<br />

Distribution GmbH & Co. KG<br />

500 mg Lilly Pharma Fertigung und<br />

Distribution GmbH & Co. KG<br />

30/04/04<br />

31/07/04<br />

1 g CHEPHASAAR GmbH 31/12/08


EN<br />

1342 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13826 Vancomycin — Mip 500 Vancomycinum Powder for solution<br />

for intravenous<br />

infusion or for oral<br />

solution<br />

13827 Vanguard 5/CV-L Szczepionka przeciw<br />

parwowirozie,<br />

koronawirozie,<br />

nosówce, zakaz´nemu<br />

zapaleniu wa˛troby,<br />

zakaz´nemu zapaleniu<br />

krtani i tchawicy,<br />

leptospirozie psów.<br />

13828 Vanguard 5L Szczepionka przeciw<br />

nosówce, zakaz´nemu<br />

zapaleniu wa˛troby,<br />

parwowirusowej<br />

chorobie psów,<br />

parainfluenzie i<br />

leptospirozie<br />

13829 Vanguard Plus 5/CV-L Szczepionka dla psów<br />

przeciw zakaz˙eniom<br />

wywołanym przez<br />

wirusy: nosówki,<br />

adenowirusy typu 1 i<br />

2, wirus parainfluenzy,<br />

parwowirus,<br />

koronawirus oraz<br />

przeciw leptospirozie.<br />

13830 Vanguard Plus 5/L Szczepionka dla psów<br />

przeciw zakaz˙eniom<br />

wywołanym przez<br />

wirusy: nosówki,<br />

adenowirusy typu 1 i<br />

2, wirus parainfluenzy,<br />

parwowirus oraz<br />

przeciw leptospirozie.<br />

13831 Vanguard Plus CPV Szczepionka przeciw<br />

parwowirusowej<br />

chorobie psów<br />

13832 Vanguard Plus CPV/CV Szczepionka dla psów<br />

przeciw zakaz˙eniom<br />

koronawirusowym i<br />

parwowirusowej<br />

chorobie psów<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate +<br />

suspension<br />

500 mg CHEPHASAAR GmbH 31/12/08<br />

for veterinary<br />

use<br />

Lyophilisate + liquid for veterinary<br />

use<br />

Lyophilisate + liquid for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

13833 Vanmixan 500 Vancomycinum Lyophilisate for<br />

solution for<br />

intravenous injection<br />

13834 Vaqta 25 Vaccinum hepatitidis A Suspension for<br />

intramuscular<br />

injection<br />

13835 Vaqta 50 Vaccinum hepatitidis A Suspension for<br />

intramuscular<br />

injection<br />

13836 Variderm Benzocainum +<br />

Mentholum + Zinci<br />

oxydum<br />

Cutaneous paste (10mg + 10mg<br />

+ 300mg) /g<br />

Pfizer 31/12/07<br />

Pfizer 6/10/04<br />

Pfizer 31/12/08<br />

Pfizer 17/07/05<br />

Pfizer 31/07/05<br />

Pfizer 29/06/06<br />

0.5 g Sanofi Winthrop-Gentilly<br />

Cedex<br />

50 U/ml Merck Sharp & Dohme Idea<br />

Inc.<br />

50 U/ml Merck Sharp & Dohme Idea<br />

Inc.<br />

Profarm — Przedsie˛biorstwo<br />

Produkcji Farmaceutyczno-<br />

Kosmetycznej Sp. z o.o.<br />

13837 Varikopax B Cream 300 mg/g Florin Chemical and Trade<br />

Co.Ltd. 1<br />

31/12/08<br />

31/07/04<br />

31/07/04<br />

31/01/06<br />

30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1343<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13838 Varilrix Varicella, live attenuated Lyophilisate and<br />

solvent for solution<br />

for subcutaneous<br />

injection<br />

13839 Varitect Solution for<br />

intravenous infusion<br />

2000 PFU/<br />

dawke˛<br />

SmithKline Beecham<br />

Biologicals<br />

31/01/05<br />

25 j.m./ml Biotest Pharma GmbH 30/04/04<br />

13840 Vascor Simvastatinum Film-coated tablets 5 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

13841 Vascor Simvastatinum Film-coated tablets 10 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

13842 Vascor Simvastatinum Film-coated tablets 20 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

13843 Vascor Simvastatinum Film-coated tablets 40 mg BIOVENA PHARMA Sp.<br />

z.o.o.<br />

13844 Vasexten 10 Barnidipini<br />

hydrochloridum<br />

13845 Vasexten 20 Barnidipini<br />

hydrochloridum<br />

Modified release<br />

capsules, hard<br />

Modified release<br />

capsules, hard<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

10 mg Yamanouchi Europe B.V. 25/04/07<br />

20 mg Yamanouchi Europe B.V. 25/04/07<br />

13846 Vasilip Simvastatinum Film-coated tablets 10 mg Krka d.d., Novo mesto 30/09/04<br />

13847 Vasilip Simvastatinum Film-coated tablets 10 mg KRKA Polska Sp. Z o.o.<br />

(Równoległa)<br />

29/11/06<br />

13848 Vasilip Simvastatinum Film-coated tablets 20 mg Krka d.d., Novo mesto 30/09/04<br />

13849 Vasilip Simvastatinum Film-coated tablets 20 mg KRKA Polska Sp. Z o.o.<br />

(Równoległa)<br />

29/11/06<br />

13850 Vasilip Simvastatinum Film-coated tablets 40 mg KRKA d.d., Novo mesto 30/09/04<br />

13851 Vasolastine Solution for<br />

intramuscular<br />

injection<br />

Enzypharm B.V. 31/03/05<br />

13852 Vasomax Phentolaminum Tablets 40 mg Schering-Plough Corporation 31/12/08<br />

13853 Vasosan P Colestyraminum Granules 740 mg/g Felgenträger & Co. Oko.-<br />

Chem. Und Pharma GmbH<br />

13854 Vasosan S Colestyraminum Granules 740 mg/g Felgenträger & Co. Oko.-<br />

Chem. Und Pharma GmbH<br />

30/01/05<br />

30/01/05<br />

13855 Vastan Simvastatinum Film-coated tablets 10 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

13856 Vastan Simvastatinum Film-coated tablets 20 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

13857 Vaxidrop Szczepionka przeciw<br />

syndromowi spadku<br />

nies´nos´ci dla kur<br />

13858 Vaxigrip Influenza, inactivated,<br />

whole virus<br />

13859 Vaxigrip Influenza, purified<br />

antigen<br />

13860 Vaxigrip Junior Influenza, inactivated,<br />

whole virus<br />

Suspension for veterinary<br />

use<br />

Suspension for<br />

intramuscular oraz<br />

deep subcutaneous<br />

injection<br />

Suspension for<br />

intramuscular oraz<br />

deep subcutaneous<br />

injection<br />

Suspension for<br />

intramuscular and<br />

intravenous injection<br />

Merial 30/06/04<br />

0.5 ml Aventis Pasteur S.A. 31/12/08<br />

10 dawek Aventis Pasteur S.A. 31/12/08<br />

0.25 ml Aventis Pasteur S.A. 30/06/05


EN<br />

1344 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13861 Vaxosin Doxazosinum Tablets 1 mg Norton Healthcare Ltd. 31/12/08<br />

13862 Vaxosin Doxazosinum Tablets 2 mg Norton Healthcare Ltd. 31/12/08<br />

13863 Vaxosin Doxazosinum Tablets 4 mg Norton Healthcare Ltd. 31/12/08<br />

13864 V-cylina Phenoxymethylpenicillinum<br />

Tablets 400000 j.m. Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

13865 Vecort Flumetazon Solution for veterinary<br />

use<br />

Warszawskie Zakłady<br />

Farmaceutyczne Polfa<br />

30/10/05<br />

28/12/04<br />

13866 Vectavir Panciclovirum Cream 10 mg/g Novartis Pharma AG 31/08/04<br />

13868 Vegantalgin H Butylscopolaminum +<br />

Paracetamolum<br />

13867 Vegantalgin H Butylscopolaminum +<br />

Paracetamolum<br />

Film-coated tablets 10mg +<br />

500mg<br />

Suppository (10mg +<br />

800mg)/2,7g<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

13869 Vegevit B12 Cyanocobalaminum Tablets 5 mcg G.R. Lane Health Products<br />

Ltd.<br />

13870 Velafax Venlafaxinum Tablets 37,5 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

13871 Veliran Liquid Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

13872 Venacorn Coated tablets Farmaceutyczna Spółdzielnia<br />

Pracy ‘Filofarm’ , Bydgoszcz<br />

17/01/07<br />

17/01/07<br />

31/07/04<br />

31/12/08<br />

31/12/08<br />

31/01/06<br />

13873 Venactiv Capsules, hard Herbapol — Lublin S.A. 31/12/08<br />

13874 Venagin Gel Instytut Farmaceutyczny 31/12/08<br />

13875 Venastat Hippocastani semen<br />

extractum siccum<br />

Prolonged release<br />

capsules, hard<br />

240mg-290mg Boehringer Ingelheim<br />

International GmbH<br />

30/09/04<br />

13876 Venavit Bional Pharma BV 31/12/08<br />

13877 Vendal retard Morphinum Film-coated, slow<br />

release tablets<br />

13878 Vendal retard Morphinum Film-coated, slow<br />

release tablets<br />

13879 Vendal retard Morphinum Film-coated, slow<br />

release tablets<br />

13880 Vendal retard Morphinum Film-coated, slow<br />

release tablets<br />

13881 Vendal retard Morphinum Film-coated, slow<br />

release tablets<br />

13882 Venescin Hippocastani semen<br />

extractum siccum +<br />

Troxerutinum<br />

10 mg Lannacher Heilmittel GmbH 31/12/08<br />

100 mg Lannacher Heilmittel GmbH 31/12/08<br />

200 mg Lannacher Heilmittel GmbH 31/12/08<br />

30 mg Lannacher Heilmittel GmbH 31/12/08<br />

60 mg Lannacher Heilmittel GmbH 31/12/08<br />

Gel Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

13883 Venescin Coated tablets Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

13884 Venescin — Forte Coated tablets preparat<br />

złoz˙ony<br />

13885 Venimmun N Immunoglobulinum<br />

humanum<br />

Lyophilisate and<br />

solvent for solution<br />

for intravenous<br />

infusion<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

30/10/05<br />

23/11/05<br />

31/12/08<br />

50 mg/ml Centeon Pharma GmbH 30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1345<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13886 Venitan Hippocastani semen<br />

extractum siccum<br />

Cutaneous cream 50 mg/g Lek Pharmaceuticals d.d. 30/04/04<br />

13887 Venitan Gel 1 g/100 g Lek Pharmaceuticals d.d. 31/12/07<br />

13888 Venlax Venlafaxinum Tablets, capsules<br />

(modified release)<br />

37,5 mg,<br />

75 mg, 75 mg,<br />

150 mg<br />

GENEXO Sp.z.o.o Warszawa 31/12/08<br />

13889 Venobonisol Oral solution Laboratorium Medycyny<br />

Naturalnej BONIMED, Z˙ywiec<br />

13890 Venofer Ferri hydroxydum<br />

saccharum<br />

Solution for injection<br />

or intravenous<br />

infusion<br />

20 mg Fe+++/<br />

ml<br />

31/12/08<br />

Lek Pharmaceuticals d.d. 31/07/04<br />

13891 Venoforton Liquid Dar Natury P.P.H. 31/12/05<br />

13892 Venolan Troxerutinum Capsules 300 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

13893 Venomenhal Osa Jad pszczoły Test for diagnosis and<br />

immunoterapy<br />

13894 Venomenhal Pszczoła Jad pszczoły Test for diagnosis and<br />

immunoterapy<br />

13895 Venoplant Hippocastani semen<br />

extractum siccum<br />

Prolonged release<br />

tablets<br />

Hal Allergen Laboratories<br />

B.V.<br />

Hal Allergen Laboratories<br />

B.V.<br />

263.2 mg Dr. Willmar Schwabe GmbH<br />

& Co.<br />

13896 Venoruton 1000 Troxerutinum powder for solution 1000 mg Novartis Consumer Health<br />

S.A.<br />

13897 Venoruton 300 Troxerutinum Capsules 300 mg Novartis Consumer Health<br />

S.A.<br />

13898 Venoruton 500 Troxerutinum powder for solution 500 mg Novartis Consumer Health<br />

S.A.<br />

13899 Venoruton forte Troxerutinum Tablets 500 mg Novartis Consumer Health<br />

S.A.<br />

13900 Venoruton Gel Troxerutinum Gel 20 mg/g Novartis Consumer Health<br />

S.A.<br />

30/06/06<br />

31/12/08<br />

31/12/08<br />

14/02/07<br />

31/12/08<br />

31/07/04<br />

31/12/08<br />

31/12/08<br />

31/07/04<br />

13901 VENOSMINE Forte Diosminum Tablets 450 mg Geymonat S.p.A. 31/12/08<br />

13902 Venotonin Hippocastani semen<br />

extractum siccum<br />

Capsules, hard 100 do<br />

125 mg<br />

Phytopharm Kle˛ka S.A. 8/02/06<br />

13903 Venotrex Troxerutinum Capsules 200 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

13904 Venotrex Troxerutinum Capsules 300 mg Zakład Farmaceutyczny<br />

‘ARGON’ S.A.<br />

13905 Venotrex Troxerutinum Capsules 200 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

13906 Venotrex Troxerutinum Capsules 300 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

13907 Venotrex Troxerutinum Gel 2 % PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

13908 Venotrop Diosminum +<br />

Hesperidum<br />

Tablets 450 mg +<br />

50 mg<br />

Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

30/11/05<br />

30/11/05<br />

30/11/05<br />

30/06/07<br />

31/01/06<br />

31/12/08


EN<br />

1346 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13909 Venoz˙el Escinum + Diclofenacum<br />

+ Tribenosidum<br />

13910 Venoz˙el Forte Diclofenacum +<br />

Tribenosidum<br />

13911 Venter Sucralfatum Granules for oral<br />

suspension<br />

Gel EMO Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych doc dr hab.<br />

Farm. Michał Oginski<br />

Gel 1 g soli<br />

sodowej<br />

diklofenaku;<br />

5g<br />

trynbenozydu<br />

Wytwórnia Artykułów<br />

Farmaceutycznych i<br />

Kosmetycznych ‘EMO’<br />

31/12/08<br />

31/12/08<br />

500 mg/g Krka d.d., Novo mesto 31/07/04<br />

13912 Venter Sucralfatum Tablets 1 g Krka d.d., Novo mesto 31/07/04<br />

13913 Ventipulmin granulat Klenbuterolum Granules for veterinary<br />

use<br />

13914 Ventipulmin pro inj. Klenbuterolum Solution for veterinary<br />

use<br />

13915 Ventodisk Salbutamolum Inhalation powder 200 mcg/<br />

dawke˛<br />

13916 Ventodisk Salbutamolum Inhalation powder 400 mcg/<br />

dawke˛<br />

Boehringer Ingelheim<br />

Vetmedica GmbH<br />

Boehringer Ingelheim<br />

Vetmedica GmbH<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

13919 Ventolin Salbutamolum Nebuliser solution 1 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

13920 Ventolin Salbutamolum Nebuliser solution 2 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

13921 Ventolin Salbutamolum Nebuliser solution 5 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

13918 Ventolin Salbutamolum Pressurised inhalation,<br />

suspension<br />

13917 Ventolin Salbutamolum Spray , suspention<br />

(chlorofluorocarbons<br />

free)<br />

100 mcg/<br />

dawke˛<br />

100 mcg/<br />

dawke˛<br />

13922 Ventolin Dysk Salbutamolum Inhalation powder 200 mcg/<br />

dawke˛<br />

inhalacyjna˛<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

13923 Ventrisol Bismuthi oxydum Film-coated tablets 120 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

13924 Vepesid Etoposidum Capsules 100 mg Bristol-Myers Squibb S.p.A,<br />

Latina<br />

13925 Vepesid Etoposidum Capsules 50 mg Bristol-Myers Squibb S.p.A,<br />

Latina<br />

13926 Vepesid Etoposidum Solution for injection 20 mg/ml Bristol-Myers Squibb S.p.A,<br />

Latina<br />

13928 Veral Diclofenacum Film-coated,<br />

gastro-resistant tablets<br />

13929 Veral Diclofenacum Film-coated,<br />

gastro-resistant tablets<br />

14/11/06<br />

14/11/06<br />

30/06/04<br />

30/06/04<br />

31/12/04<br />

31/12/04<br />

31/12/04<br />

30/06/04<br />

31/10/04<br />

15/11/06<br />

31/12/05<br />

30/06/04<br />

11/12/05<br />

30/06/04<br />

25 mg Slovakofarma a.s. 31/12/08<br />

50 mg Slovakofarma a.s. 31/12/08<br />

13930 Veral Diclofenacum Gel 1 % Slovakofarma a.s. 31/12/08<br />

13927 Veral Diclofenacum Suppository 100 mg Slovakofarma a.s. 31/12/08<br />

13931 VERAL 75 Retard Diclofenacum Prolonged release<br />

tablets<br />

75 mg Slovakofarma a.s. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1347<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13932 Veramid Aminophenazonum +<br />

Barbitalum<br />

Tablets Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

13934 Verapamil Verapamilum Film-coated tablets 120 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/04<br />

31/12/08<br />

13935 Verapamil Verapamilum Film-coated tablets 40 mg Norton Healthcare Ltd. 30/06/04<br />

13936 Verapamil Verapamilum Film-coated tablets 80 mg Pabianickie Zakłady<br />

Farmaceutyczne POLFA<br />

13933 Verapamil Verapamilum Intravenous injection 5 mg/2 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

30/06/06<br />

31/12/08<br />

13937 Veratens Verapamilum Film-coated tablets 40 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

13938 Veratens Verapamilum Film-coated tablets 80 mg ICN Polfa Rzeszów S.A. 31/12/08<br />

13939 Veratrum-Homaccord Amp. Heel GmbH 31/12/08<br />

13940 Veratrum-Homaccord Drops Heel GmbH 31/12/08<br />

13941 Verazil Verapamilum Coated tablets 40 mg HEMOFARM D.D. 31/12/08<br />

13942 Verazil Verapamilum Coated tablets 80 mg HEMOFARM D.D. 31/12/08<br />

13945 Vercef Cefaclorum Capsules 250 mg Ranbaxy Laboratories Ltd. 31/12/07<br />

13946 Vercef Cefaclorum Capsules 500 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

13943 Vercef Cefaclorum Granules for oral<br />

suspension<br />

13944 Vercef Cefaclorum Granules for oral<br />

suspension<br />

13947 Vercef MR Cefaclorum Modified release<br />

tablets<br />

13948 Vermisol Lewamizolum Powder for veterinary<br />

use<br />

13949 Vermitan 10 % Albendasolum Suspension for veterinary<br />

use<br />

13950 Vermitan 20 % Albendasolum Granules for veterinary<br />

use<br />

31/12/07<br />

125 mg/5ml Ranbaxy Laboratories Ltd. 31/12/07<br />

250 mg/5 ml Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

375 mg Ranbaxy Laboratoires Ltd,<br />

New Delhi<br />

31/12/04<br />

31/12/04<br />

Interbiowet 31/12/07<br />

Ceva-PhylaxiaVeterinary<br />

Biologicals<br />

Ceva-PhylaxiaVeterinary<br />

Biologicals<br />

14/03/05<br />

1/08/04<br />

13951 Vermox Mebendazolum Tablets 100 mg Gedeon Richter Ltd. 31/07/04<br />

13952 Vermox Mebendazolum Tablets 100 mg Janssen Pharmaceutica N.V. 31/07/04<br />

13953 Vero Naproxenum Tablets 220 mg US Pharmacia Sp. z o.o. 24/08/05<br />

13954 VERORAB Rabies, inactivated,<br />

whole virus<br />

Lyophilisate and<br />

solvent for solution<br />

for intramuscular<br />

injection<br />

2.5 j.m./0,5 ml Aventis Pasteur S.A. 31/12/08<br />

13955 Verospiron Spironolactonum Capsules 100 mg Gedeon Richter Ltd. 31/05/05<br />

13956 Verospiron Spironolactonum Capsules 50 mg Gedeon Richter Ltd. 31/05/05<br />

13957 Verospiron Spironolactonum Tablets 25 mg Gedeon Richter Ltd. 31/05/04<br />

13958 Verovit Sabal fructus,Ginseng Capsule 25 mg,50 mg Kenay A.G., Cze˛stochowa 31/12/08<br />

13959 Verrumal Acidum salicylicum +<br />

Fluorouracilum<br />

Coutanous liquid Boots Healthcare<br />

International<br />

7/05/06


EN<br />

1348 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13960 Vertigoheel Amp. Heel GmbH 30/06/07<br />

13961 Vertigoheel Drops Heel GmbH 30/06/07<br />

13962 Vertigoheel Sublingual tablets Heel GmbH 30/06/07<br />

13963 Vesanoid Tretinoinum Capsules 10 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

10/05/06<br />

13964 Vessel due F Sulodexidum Capsules 250 LSU Alfa Wassermann S.p.A. 30/04/04<br />

13965 Vessel due F Sulodexidum Solution for<br />

intravenous and<br />

intramuscular<br />

injection<br />

13966 Vetacortyl Methylprednisolonum Suspension for veterinary<br />

use<br />

13967 Vetacyclinum Pulvis Tetracykliny<br />

chlorowodorek<br />

Powder for veterinary<br />

use<br />

13968 Vetaglan d-kloprostenol Solution for veterinary<br />

use<br />

13969 Vetahepar menbuton Liquid for veterinary<br />

use<br />

13970 Vetalgin Metamizolum Solution for veterinary<br />

use<br />

13971 Vetamectin Iwermektyna Solution for veterinary<br />

use<br />

13972 Vetaraxoid Hydroksyzyna,<br />

Prednizolon<br />

Tablets for veterinary<br />

use<br />

13973 Vetbutal Pentobarbital Solution for veterinary<br />

use<br />

13974 Veti PS Dihydrostreptomycyna,<br />

penicylina prokainowa<br />

13975 Vetisolon Prednizolon,<br />

Dwumetylosulfotlenek<br />

Suspension for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

13976 Vetmedin 2,5 mg Pimobendan Capsule for veterinary<br />

use<br />

13977 Vetmedin 5 mg Pimobendan Capsule for veterinary<br />

use<br />

13978 Vetminth Niklozamid,<br />

Oksybendazol<br />

Paste for veterinary<br />

use<br />

13979 Vetodexin Dexamethasonum Solution for veterinary<br />

use<br />

13980 Vetoflok 10 % Enrofloxacinum Solution for veterinary<br />

use<br />

13981 Vetoflok 5 % Enrofloxacinum Solution for injection for veterinary<br />

use<br />

13982 Vetopen 30 Benzylpenicillinum<br />

procainicum<br />

Suspension for veterinary<br />

use<br />

13983 Vetramox 80 % Amoxicillunum Powder for veterinary<br />

use<br />

300 LSU/ml Alfa Wassermann S.p.A. 30/04/04<br />

Vetoquinol S.A. 27/11/05<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

11/02/04<br />

Laboratiorios Calier SA 31/12/08<br />

Vet-Agro 31/12/08<br />

Intervet 30/04/04<br />

Vet-Agro 8/09/05<br />

Pfizer 31/12/07<br />

Biowet Puławy 10/02/04<br />

Eurovet 31/12/08<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Boehringer Ingelheim<br />

Vetmedica GmbH<br />

Boehringer Ingelheim<br />

Vetmedica GmbH<br />

29/04/04<br />

18/09/07<br />

18/09/07<br />

Virbac 28/08/04<br />

V.M.D. 31/12/08<br />

Veterina 31/12/08<br />

Pliva Kraków 3/02/07<br />

V.M.D. 31/12/08<br />

Lavet Pharmaceuticals Ltd. 8/05/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1349<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

13984 Vetramycin Benzylopenicylina<br />

prokainowa,<br />

Dihydrostreptomycyny<br />

siarczan, Pantotenian<br />

wapnia, Palmitynian<br />

retinolu<br />

13985 Vetrim Sulfadimetoksyna,<br />

Trimetoprim glicerol<br />

13986 Vetrimoxin LA trójwodzian<br />

amoksycyliny,<br />

hydroksybenzoesan<br />

metylu,<br />

13987 Veyxat Kamfora, Salicylan<br />

metylu<br />

13988 Veyxym M Trypsyna,<br />

Chymotrypsyna,<br />

Papaina, Witamina A,<br />

Witamina E<br />

Intramammary<br />

ointment<br />

for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Ointment for veterinary<br />

use<br />

Intramammary<br />

ointment<br />

for veterinary<br />

use<br />

Werfft-Chemie 14/06/04<br />

Warszawskie Zakłady<br />

Farmaceutyczne Polfa<br />

14/06/04<br />

Ceva Sante Animale 31/12/08<br />

Veyx-Pharma GmbH 18/09/07<br />

Veyx Pharma GmbH 23/10/06<br />

13990 Vfend Voriconazolum Film-coated tablets 50 mg Pfizer Polska Sp. z o.o. 31/12/08<br />

13991 Vfend Voriconazolum Film-coated tablets 200 mg Pfizer Polska Sp. z o.o. 31/12/08<br />

13989 Vfend Voriconazolum Powder for solution<br />

for intravenous<br />

injections<br />

13992 VH Z˙ywa szczepionki dla<br />

kur I indyków<br />

przeciwko rzekomemu<br />

pomorowi drobiu<br />

13993 VH + H — 120 Z˙ywa szczepionki dla<br />

kur przeciwko<br />

rzekomemu pomorowi<br />

drobiu i zakaz´nemu<br />

zapalenia oskrzeli<br />

13994 VI Bursa C.E. szczepionka dla kur<br />

przeciw zakaz´nemu<br />

zapaleniu torby<br />

fabrycjusza<br />

13995 VI Mark Serotyp 1&3, Rispens<br />

/HVT<br />

szczepionka dla<br />

kurcza˛t przeciw<br />

chorobie mareka<br />

13996 VI Mark Serotyp 3/HVT szczepionka dla kucza˛t<br />

przeciwko chorobie<br />

mareka<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Lyophilisate for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

Suspension for veterinary<br />

use<br />

200 mg Pfizer Polska Sp. z o.o. 31/12/08<br />

ABIC Ltd. 4/12/06<br />

ABIC Ltd. 4/12/06<br />

Lohmann Animal Health<br />

International<br />

Lohmann Animal Health<br />

International<br />

Lohmann Animal Health<br />

International<br />

13997 Viagra Sildenafilum Film-coated tablets 100 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

13998 Viagra Sildenafilum Film-coated tablets 25 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

13999 Viagra Sildenafilum Film-coated tablets 50 mg Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

14000 Vibovit Bobas Multivitamins and trace<br />

elements<br />

Powder for oral<br />

solution<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

14001 Vibovit Junior Buccal tablet Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/03/04<br />

31/03/04<br />

31/03/04<br />

28/12/05<br />

31/12/08


EN<br />

1350 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14002 Vibovit junior Effervescent tablets Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/12/08<br />

14003 Vibovit Junior Effervescent tablets POLFA KUTNO S.A. 31/12/08<br />

14004 Vibovit Junior Effervescent tablets POLFA KUTNO S.A. 31/12/08<br />

14005 Vibovit Junior Effervescent tablets POLFA KUTNO S.A. 31/12/08<br />

14006 Vibovit Junior o smaku<br />

bananowym<br />

14007 Vibovit Junior o smaku<br />

brzoskwiniowym<br />

14008 Vibovit Junior o smaku<br />

cytrynowym<br />

14009 Vibovit junior o smaku<br />

cytrynowym<br />

14010 Vibovit junior o smaku<br />

grejpfrutowym<br />

14011 Vibovit Junior o smaku<br />

pomarańczowym<br />

14012 Vibovit Junior o smaku<br />

waniliowym<br />

Multivitamins and trace<br />

elements<br />

Multivitamins and trace<br />

elements<br />

Multivitamins and trace<br />

elements<br />

Multivitamins and trace<br />

elements<br />

Multivitamins and trace<br />

elements<br />

Powder for oral<br />

solution<br />

Powder for oral<br />

solution<br />

Powder for oral<br />

solution<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Buccal tablet Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Buccal tablet Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Powder for oral<br />

solution<br />

Powder for oral<br />

solution<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

14013 VIBOVIT® Mama Preparat złoz˙ony Film-coated tablets Kutnowskie Zakłady<br />

Farmaceutyczne Polfa Kutno<br />

S.A.<br />

14015 Vibrocil Dimetindenum +<br />

Phenylephrinum<br />

14016 Vibrocil Dimetindenum +<br />

Phenylephrinum<br />

14014 Vibrocil Dimetindenum +<br />

Phenylephrinum<br />

Nasal drops, solution (0,25mg +<br />

2,5mg)/ml<br />

Nasal gel (0,25mg +<br />

2,5mg)/ml<br />

Nasal spray, solution (0,25mg +<br />

2,5mg)/ml<br />

Novartis Consumer Health<br />

S.A.<br />

Novartis Consumer Health<br />

S.A.<br />

Novartis Consumer Health<br />

S.A.<br />

28/12/05<br />

28/12/05<br />

28/12/05<br />

23/11/05<br />

23/11/05<br />

28/12/05<br />

28/12/05<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

14017 Viburcol N Suppository Heel GmbH 30/06/07<br />

14018 Vicalvit Calcii carbonas Buccal tablet 500 mg Ca++ Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

14019 Vicalvit D Calcii carbonas +<br />

Colecalciferolum<br />

14020 Vicalvit D Calcii carbonas +<br />

Colecalciferolum<br />

14021 Vicalvit D 400 Calcii carbonas +<br />

Colecalciferolum<br />

Effervescent powder 500mg Ca +<br />

200 j.m vit. D3<br />

Effervescent tablets 500mg Ca +<br />

200 j.m vit. D3<br />

Buccal tablet 500mg +<br />

400 j.m.<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/07/05<br />

31/12/05<br />

31/03/07<br />

31/12/05<br />

14022 Vicefar 500 Acidum ascorbicum Tablets 500 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

14023 Vicevit Acidum ascorbicum<br />

(vit C)<br />

14024 Vicevit 500 Acidum ascorbicum<br />

(vit C)<br />

14025 Vicevit Forte Acidum ascorbicum<br />

(vit C)<br />

Buccal tablets 50 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Modified release<br />

capsules<br />

500 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Effervescent powder 500 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

14026 Videtrin Colecalciferolum Capsules, hard 400 j.m.<br />

Witaminy D3<br />

Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

31/03/06<br />

30/11/05<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1351<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14027 Videtrin Colecalciferolum Capsules, hard 1000 j.m.<br />

Witaminy D3<br />

14030 Videx Didanosinum Chewable tablets or<br />

for suspension<br />

14031 Videx Didanosinum Chewable tablets or<br />

for suspension<br />

14032 Videx Didanosinum Chewable tablets or<br />

for suspension<br />

14033 Videx Didanosinum Chewable tablets or<br />

for suspension<br />

14028 Videx Didanosinum Powder for oral<br />

suspension<br />

14029 Videx Didanosinum Powder for oral<br />

suspension<br />

Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

31/12/08<br />

100 mg Bristol-Myers Squibb Co. 30/06/07<br />

150 mg Bristol-Myers Squibb Co. 30/06/07<br />

25 mg Bristol-Myers Squibb Co. 30/06/07<br />

50 mg Bristol-Myers Squibb Co. 30/06/07<br />

2 g Bristol-Myers Squibb Co. 31/01/05<br />

4 g Bristol-Myers Squibb Co. 31/01/05<br />

14034 Videx Didanosinum Tablets 200 mg Bristol — Myers Squibb 14/02/07<br />

14035 Videx EC Didanosinum Gastro-resistant<br />

capsules, hard<br />

14036 Videx EC Didanosinum Gastro-resistant<br />

capsules, hard<br />

14037 Videx EC Didanosinum Gastro-resistant<br />

capsules, hard<br />

14038 Videx EC Didanosinum Gastro-resistant<br />

capsules, hard<br />

14039 Vidibion Kalii iodidum + Natrii<br />

iodidum<br />

Eye drops, solution (3 mg + 3 mg)/<br />

ml<br />

125 mg Bristol-Myers Squibb 14/02/07<br />

200 mg Bristol-Myers Squibb 14/02/07<br />

250 mg Bristol-Myers Squibb 14/02/07<br />

400 mg Bristol-Myers Squibb 14/02/07<br />

Bioton Sp. z o.o. 31/12/08<br />

14040 Vidisept Polyvidonum Eye drops, solution 50 mg/ml Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

14041 Vidisic Carbomerum Gel 2 mg/g Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

14042 Vigantol Colecalciferolum Oral drops, solution 20000 j.m./ml<br />

(0,5 mg/ml)<br />

14043 Vigantol 50 000 Colecalciferolum Solution for<br />

intramuscular<br />

injection<br />

50000 j.m./<br />

1ml<br />

14044 Vigantoletten 500 Colecalciferolum Tablets 500 j.m.<br />

(0,0125mg)<br />

14045 Vigantoletten 1000 Colecalciferolum Tablets 1000 j.m.<br />

(0,025mg)<br />

16/01/06<br />

31/03/07<br />

Merck KGaA 30/06/04<br />

Merck KGaA 30/04/04<br />

Merck KGaA 30/06/04<br />

Merck KGaA 30/06/04<br />

14046 Vigil Modafinilum Tablets 100 mg ratiopharm GmbH 31/08/04<br />

14047 Vigor Complet Preparat złoz˙ony Film-coated tablets US Pharmacia Sp. z o.o. 31/12/08<br />

14048 Vigor Complet Witaminy Film-coated tablets US Pharmacia 31/12/08<br />

14049 Vigor Complete Film-coated tablets US Pharmacia Sp. z o.o. 31/12/08<br />

14050 Vigor Junior Buccal tablet US Pharmacia Sp. z o.o. 30/09/04<br />

14051 Vigor Senior Preparat złoz˙ony Film-coated tablets US Pharmacia Sp. z o.o. 31/05/06<br />

14052 Vigor Senior Film-coated tablets US Pharmacia Sp. z o.o. 31/05/06<br />

14053 Vigor Senior Plus Witaminy Film-coated tablets US Pharmacia 31/12/08


EN<br />

1352 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14054 Vigosal Multivitamins and trace<br />

elements<br />

Film-coated tablets Puritan's Pride, Incorporated 31/07/04<br />

14055 Vilcacora® Uncaria Tomentosa Capsules Laboratorios INDUQUIMICA<br />

s.a., Peru<br />

14056 Vilpin Amlodipinum Tablets 10 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

14057 Vimblastine Therabel Vinblastinum powder and solvent<br />

for solution for<br />

injection<br />

14058 Vinblastin Vinblastinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

14059 Vincristin Vincristinum Lyophilisate and<br />

solvent for solution<br />

for injection<br />

10 mg Therabel Pharma<br />

(Laboratories Thisen)<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

5 mg Gedeon Richter Ltd. 31/05/04<br />

1 mg Gedeon Richter Ltd. 31/05/04<br />

14060 Vincristin Liquid Vincristinum Solution for injection 1 mg/ml Gedeon Richter Ltd. 31/07/04<br />

14061 Vincristine Sulfate Vincristinum Solution for injection 1 mg/ml Pharmacia & Upjohn Pty Ltd. 31/01/05<br />

14062 Vinicard Drops Lehning Laboratoires 31/12/08<br />

14063 Vinpocetine Vinpocetinum Tablets 5 mg P.P.H.U. Biofarm Sp. z o.o. 31/12/07<br />

14064 Vinpocetine Vinpocetinum Tablets 5 mg Aflofarm 31/12/07<br />

14065 Vinpocetine Vinpocetinum Tablets 5 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

14066 Vinpocetine Vinpocetinum Tablets 5 mg Chemiczno —<br />

Farmaceutyczna Spółdzielnia<br />

Pracy ESPEFA<br />

14067 Vinpocetine Vinpocetinum Tablets 5 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

14068 Vinpoton Vinpocetinum Tablets 5 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

14069 Viokase 16 Pancreatinum Tablets 16000 j. USP<br />

lipasy<br />

14070 Viokase 8 Pancreatinum Tablets 800 j. USP<br />

lipasy<br />

14071 Viosept Clioquinolum +<br />

Domipheni bromidum +<br />

Tripelennaminum<br />

Ointment (20mg + 20mg<br />

+ 500mcg)/G<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

10/01/06<br />

Axcan Pharma Inc. 31/12/08<br />

Axcan Pharma Inc. 31/12/08<br />

Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

14073 Vioxx 12,5 Rofecoxibum Oral suspension 12.5 mg/5ml Merck Sharp & Dohme Idea<br />

Inc.<br />

14072 Vioxx 12,5 Rofecoxibum Tablets 12.5 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

14075 Vioxx 25 Rofecoxibum Oral suspension 25 mg/5ml Merck Sharp & Dohme Idea<br />

Inc.<br />

14074 Vioxx 25 Rofecoxibum Tablets 25 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

14076 Vioxx Forte Rofecoxibum Tablets 50 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

30/11/05<br />

30/11/04<br />

30/11/04<br />

30/11/04<br />

30/11/04<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1353<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14077 Viprinex Ancrodum Concantrate for<br />

solution for<br />

intravenous infusion<br />

70 j.m./ml Abbott GmbH & Co KG 30/04/04<br />

14078 Viprosal B Ointment 0.05 j.m./g Tallińskie Zakłady<br />

Farmaceutyczne<br />

14079 Viprosal B Ointment Tallińskie Zakłady<br />

Farmaceutyczne<br />

14080 Viracir Aciclovirum Tablets 200 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

14082 Viramune Nevirapinum Oral suspension 50 mg/5ml Boehringer Ingelheim<br />

International GmbH<br />

14081 Viramune Nevirapinum Tablets 200 mg Boehringer Ingelheim<br />

International GmbH<br />

14083 Virbamax Abamectinum Solution for veterinary<br />

use<br />

14084 Virbamec Injectable Iwermektyna Solution for veterinary<br />

use<br />

21/06/06<br />

31/12/06<br />

27/09/06<br />

7/06/05<br />

31/10/04<br />

Virbac do Brasil 31/12/08<br />

Virbac do Brasil 31/12/08<br />

14085 Viregyt K Amantadinum Capsules 100 mg Egis Pharmaceuticals Ltd. 30/01/05<br />

14086 Viridal Benzydamidum Liquid 0,15 % Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

14087 Virlix Cetirizinum Film-coated tablets 10 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

14088 Virlix® Cetirizinum Oral solution 1 mg/ml PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/05<br />

31/12/08<br />

14089 Virolex Aciclovirum Cream 50 mg/g Krka d.d., Novo mesto 30/04/04<br />

14090 Virolex Aciclovirum Eye ointment 30 mg/g Krka d.d., Novo mesto 31/07/04<br />

14091 Virolex Aciclovirum Powder for solution<br />

for intravenous<br />

injection<br />

250 mg Krka d.d., Novo mesto 31/07/04<br />

14092 Virolex Aciclovirum Tablets 200 mg Krka d.d., Novo mesto 31/07/04<br />

14093 Virostat interferon alfa 2b +<br />

ribavirin<br />

Capsules zestaw Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

31/12/08<br />

14094 Viru-Merz Tromantadinum Gel 10 mg/g Merz & Co. GmbH 31/07/04<br />

14095 Visaflos Herbal tea Herbaflos, Płońsk 31/12/08<br />

14096 Viscoat Acidum hyaluronicum +<br />

Chondroitini sulfas<br />

Solution for<br />

intraocular use<br />

Alcon Laboratoires Inc Texas 30/04/04<br />

14097 Viscoten — fix Mieszanka ziołowa Instant herbal tea Herbapol — Gdańsk Sp.<br />

z o.o. — Zastawna<br />

30/10/05<br />

14098 VISCUM comp. amp. WALA-Heilmittel GmbH 19/03/05<br />

14099 VISCUM comp. gran. WALA-Heilmittel GmbH 19/03/05<br />

14100 Viscum Compositum forte Amp. Heel GmbH 31/12/08<br />

14101 Viscum Compositum medium Amp. Heel GmbH 31/12/08<br />

14102 Viscum Compositum mite Amp. Heel GmbH 31/12/08<br />

14103 Viscum/Crataegus Amp. 1 ml WALA-Heilmittel GmbH 24/05/07


EN<br />

1354 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14104 Viscum/Crataegus Granules WALA-Heilmittel GmbH 24/05/07<br />

14105 Viscum-Dagomed 16<br />

nieustabilizowane cis´nienie<br />

DAGOMED-Pharma Sp. zo.o.,<br />

Warszawa<br />

14106 Visine Tetryzolinum Eye drops, solution 0.5 mg/ml Pfizer Canada Inc. Consumer<br />

Healthcare DIV<br />

14107 Visipaque Iodixanolum Solution for<br />

intravenous and<br />

intraarterial injection<br />

14108 Visipaque Iodixanolum Solution for<br />

intravenous and<br />

intraarterial injection<br />

14109 Visipaque Iodixanolum Solution for<br />

intravenous and<br />

intraarterial injection<br />

31/01/06<br />

30/06/04<br />

305 mg/ml Nycomed Imaging AS 30/04/05<br />

550 mg/ml Nycomed Imaging AS 30/04/05<br />

625 mg/ml Nycomed Imaging AS 30/04/05<br />

14110 Visken Pindololum Tablets 5 mg Egis Pharmaceuticals Ltd. 31/01/05<br />

14111 Visken Pindololum Tablets 5 mg Novartis Pharma AG 31/01/05<br />

14112 Visolvit Preparat złoz˙ony Film-coated tablets GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

14113 Visolvit o smaku<br />

pomarańczowym<br />

14114 VISOLVIT® O Smaku<br />

Truskawkowym<br />

Preparat złoz˙ony Effervescent granules GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Preparat złoz˙ony Effervescent granules GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

14115 Visudyne Verteporfin Powder for solution<br />

for intravenous<br />

injection<br />

14116 Vit.E 50 + Se Pro inj. Witamina E, Selenin<br />

sodu<br />

Solution for veterinary<br />

use<br />

15 mg Novartis Ophthalmics AG<br />

Hettlingen<br />

12/10/05<br />

31/12/05<br />

31/12/08<br />

9/08/06<br />

Eurovet International 23/01/05<br />

14117 Vita — Gem C Acidum ascorbicum Effervescent powder 200 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

14118 Vita — Gem C Acidum ascorbicum Effervescent powder 1000 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

14119 Vita Buerlecithin Multivitamins and trace<br />

elements<br />

Oral solution Altana Consumer Health<br />

GmbH<br />

14120 Vita Buerlecithin Coated tablets Altana Consumer Health<br />

GmbH<br />

14121 Vita C Witamina c Solution for veterinary<br />

use<br />

31/12/08<br />

31/12/08<br />

30/06/04<br />

30/06/04<br />

Vetoquinol 31/12/08<br />

14122 Vita C 100 Acidum ascorbicum Buccal tablets 100 mg HOVID Sdn. Bhd. 31/12/08<br />

14123 Vita Care B-Long Preparat złoz˙ony Film-coated,<br />

gastro-resistant tablets<br />

14124 Vita Care C-long Acidum ascorbicum<br />

(vit C)<br />

Prolonged release<br />

tablets<br />

Jemo — Pharm A/S 31/12/08<br />

500 mg Jemo-Pharm A/S 6/12/06<br />

14125 Vita Care Koenzym Q10 Ubidecarenonum Buccal tablets 10 mg Jemo — Pharm A/S 31/12/08<br />

14126 Vita Care Neutral C-long Acidum ascorbicum<br />

(vit C)<br />

Film-coated, prologed<br />

release tablets<br />

200 mg Jemo-Pharm A/S 6/12/06<br />

14127 Vita Care Q10 Ubidecarenonum Capsules 30 mg Jemo-Pharm A/S 30/04/04<br />

14128 Vita Care Q10 Ubidecarenonum Capsules 60 mg Jemo-Pharm A/S 30/04/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1355<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14129 Vita Care Q10 D Ubidecarenonum Buccal tablet 30 mg Jemo-Pharm A/S 10/05/06<br />

14130 Vita Day Film-coated tablets America's Best Nutritional<br />

Products Inc.<br />

31/12/08<br />

14131 Vita E Tocopherolum Tablets 100 mg Vitabalans Oy 31/12/08<br />

14132 Vita Es Tocopherolum Tablets 200 mg Vitabalans Oy 31/12/08<br />

14133 Vita-Gem C Acidum acsorbicum Effervescent powder 500 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘GEMI’<br />

14134 Vita Kid Buccal tablet America's Best Nutritional<br />

Products Inc.<br />

31/12/08<br />

31/12/08<br />

14135 Vita-B2 Riboflavinum (vit B2) Tablets 3 mg VITABALANS Oy 14/12/05<br />

14136 Vitacalcin o smaku<br />

mandarynkowym<br />

14137 Vitacalcin o smaku<br />

pomarańczowym<br />

Calcii carbonas Powder for oral<br />

suspension<br />

Calcii carbonas Powder for oral<br />

suspension<br />

500 mg Ca++/<br />

3g<br />

500 mg Ca++/<br />

3g<br />

Slovakofarma a.s. Hlodovec 12/10/05<br />

Slovakofarma a.s. Hlodovec 12/10/05<br />

14138 Vitacare Q 10 Ubidecarenonum Capsules 30 mg Jemo — Pharm A/S 31/12/08<br />

14139 Vitacare Q 10 Ubidecarenonum Capsules 60 mg Jemo — Pharm A/S 31/12/08<br />

14140 Vitacitrol Retinolum +<br />

Ergocalciferolum +<br />

Acidum ascorbicum<br />

Syrup wit.A<br />

2500 j.m.+ wit.<br />

D3<br />

PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

14141 Vita-Complete 29 Film-coated tablets Jamieson Laboratoires 9/08/06<br />

14144 Vitacon Phytomenadionum Film-coated tablets 10 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14142 Vitacon Phytomenadionum Solution for injection 1 mg/0,5 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14143 Vitacon Phytomenadionum Solution for injection 10 mg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

30/10/05<br />

30/10/05<br />

14145 Vita-Fem Film-coated tablets Puritan's Pride, Incorporated 31/07/04<br />

14146 Vitafort Witaminy a, d3, e, m,<br />

pp, c, k3, witaminy z<br />

grupy B, magnez<br />

14147 Vitalipid N Adult Multivitamins and trace<br />

elements<br />

14148 Vitalipid N Infant Multivitamins and trace<br />

elements<br />

14149 Vita-Merfen Benzoxonii chloridum +<br />

Chlorhexidinum +<br />

Retinolum<br />

Liquid for veterinary<br />

use<br />

Concentrate for<br />

emulsion for<br />

intravenous infusion<br />

Concentrate for<br />

emulsion for<br />

intravenous infusion<br />

Ointment (1mg + 5mg +<br />

2000j.m.)/g<br />

Biowet Puławy 31/12/08<br />

Fresenius Kabi AB Uppsala 31/07/04<br />

Fresenius Kabi AB Uppsala 31/07/04<br />

Novartis Consumer Health<br />

S.A.<br />

30/09/04<br />

14150 Vitamin 15 Film-coated tablets ICN Switzerland AG 31/07/04<br />

14151 Vitamin AD3E pro injectione Witamina a, d3, e Solution for veterinary<br />

use<br />

14152 Vitamin D 5000<br />

Slovakofarma®<br />

Bela-Pharm 31/12/08<br />

Colecalciferolum Capsules 5000 j.m. Slovakofarma a.s. 31/12/08<br />

14153 Vitamin D 800 Slovakofarma® Colecalciferolum Capsules 800 j.m. Slovakofarma a.s. 31/12/08<br />

14154 Vitamin E 100 Tocopherolum Capsules 100 mg Slovakofarma a.s. 30/04/04


EN<br />

1356 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14155 Vitamin E 200 Tocopherolum Capsules 200 mg Slovakofarma a.s. 30/04/04<br />

14156 Vitamin E 400 Tocopherolum Capsules 400 mg Slovakofarma a.s. 30/04/04<br />

14157 Vitamina C Acidum ascorbicum Capsuels, hard 500 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

14158 Vitaminum A Retinolum Capsules 12000 j.m. Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

14159 Vitaminum A Retinolum Capsules, soft 5000 j.m. Przedsie˛biorstwo<br />

Farmaceutyczno —<br />

Chemiczne ‘Synteza’ Sp.<br />

z o.o.<br />

14160 Vitaminum A Retinolum Capsules, soft 10 000 j.m. Przedsie˛biorstwo<br />

Farmaceutyczno —<br />

Chemiczne ‘Synteza’ Sp.<br />

z o.o.<br />

14161 Vitaminum A Retinolum Capsules, soft 6000 j.m. Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

14162 Vitaminum A Retinolum Oral drops, solution 27,5 mg / 1 ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

14163 Vitaminum A Retinolum (vit A) Capsules 12000 j.m. GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

14164 Vitaminum A + E Retinolum +<br />

Tocopherolum<br />

14165 Vitaminum A 12000 + E70 Retinolum +<br />

Tocopherolum<br />

14166 Vitaminum A 2000+D3 400 Colecalciferolum +<br />

Retinolum<br />

Capsules, soft 30 000 j.m.,<br />

70 mg<br />

Gelatin capsules, soft 12000 j.m. +<br />

70mg<br />

Capsules, soft 400 j.m. +<br />

2000 j.m.<br />

Przedsie˛biorstwo<br />

Farmaceutyczno —<br />

Chemiczne ‘Synteza’ Sp.<br />

z o.o.<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

14167 Vitaminum A 2500 Retinolum Capsules, soft 2500 j.m Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

14168 Vitaminum A solutio aquosa Retinolum Oral solution 50000 j.m./ml Medana Pharma Terpol<br />

Group S.A.<br />

14169 Vitaminum A+D3 Colecalciferolum +<br />

Retinolum<br />

Capsules 1000j.m. +<br />

2000 j.m.<br />

14170 Vitaminum A+D3 Witaminy A i D3 Solution for veterinary<br />

use<br />

14171 Vitaminum A+D3 solutio<br />

aquosa<br />

Colecalciferolum +<br />

Retinolum<br />

14172 Vitaminum A+E Retinolum (vit A) +<br />

Tocopherolum<br />

14173 Vitaminum A+E Retinolum +<br />

Tocopherolum<br />

14174 Vitaminum A+E Retinolum +<br />

Tocopherolum<br />

14175 Vitaminum A+E Retinolum +<br />

Tocopherolum<br />

Oral solution 20000 j.m +<br />

10000j.m.<br />

Capsules 30000j.m. +<br />

70mg<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Warszawskie Zakłady<br />

Farmaceutyczne Polfa<br />

Medana Pharma Terpol<br />

Group S.A.<br />

GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

7/05/06<br />

31/01/06<br />

31/12/08<br />

31/12/08<br />

12/10/05<br />

31/01/06<br />

31/01/06<br />

31/12/08<br />

30/04/06<br />

29/03/06<br />

14/12/05<br />

31/01/06<br />

31/12/05<br />

17/08/04<br />

31/01/06<br />

31/12/05<br />

Capsuels, hard US Pharmacia Sp. z o.o. 30/04/05<br />

Capsules, soft 2500 j.m +<br />

200mg<br />

Medana Pharma Terpol<br />

Group S.A.<br />

Capsules, soft Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

31/12/05<br />

14/12/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1357<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14176 Vitaminum A+E Retinolum +<br />

Tocopherolum<br />

Capsules, soft 30 000 j.m. +<br />

70mg<br />

14177 Vitaminum AD3E Witamina a, d3, e Solution for veterinary<br />

use<br />

14178 Vitaminum B compositum Multivitamins and trace<br />

elements<br />

Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

14/12/05<br />

Biowet Gorzów 31/12/08<br />

Coated tablets Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

14179 Vitaminum B compositum Prep. Witaminowy Coated tablets Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14180 Vitaminum B compositum Prep. Witaminowy Film-coated tablets Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/06<br />

30/11/05<br />

31/03/07<br />

14181 Vitaminum B compositum Film-coated tablets Polfarmex S.A 12/10/05<br />

14182 Vitaminum B1 Thiaminum (vit B1) Solution for<br />

intramuscular<br />

injection<br />

14183 Vitaminum B1 Thiaminum (vit B1) Solution for<br />

intramuscular<br />

injection<br />

10 mg/1 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

25 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

14184 Vitaminum B1 Thiaminum (vit B1) Tablets 25 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/04/05<br />

30/04/05<br />

30/11/05<br />

14185 Vitaminum B1 Thiaminum (vit B1) Tablets 25 mg Polfarmex S.A 30/09/07<br />

14186 Vitaminum B1 Thiaminum (vit B1) Tablets 25 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

14187 Vitaminum B1 Thiaminum (vit B1) Tablets 3 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/01/05<br />

30/04/05<br />

14188 Vitaminum B1 Thiaminum (vit B1) Tablets 3 mg Polfarmex S.A 30/04/05<br />

14189 Vitaminum B1 Thiaminum (vit B1) Tablets 3 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

14190 Vitaminum B1 Tiaminy<br />

chlorowodorek<br />

Solution for veterinary<br />

use<br />

30/04/05<br />

Biowet Puławy 14/04/05<br />

14191 Vitaminum B12 Cyanocobalaminum Solution for injection 100 mcg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14192 Vitaminum B12 Cyanocobalaminum Solution for injection 500 mcg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14193 Vitaminum B2 Riboflavinum (vit B2) Coated tablets 3 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

14195 Vitaminum B2 Riboflavinum (vit B2) Film-coated tablets 3 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

14194 Vitaminum B2 Riboflavinum (vit B2) Solution for injection 5 mg/1 ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

14196 Vitaminum B6 Pyridoxinum (vit B6) Solution for injection 25 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

14197 Vitaminum B6 Pyridoxinum (vit B6) Tablets 50 mg Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

14198 Vitaminum B6 Pyridoxinum (vit B6) Tablets 50 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

30/10/05<br />

30/11/05<br />

30/11/05<br />

31/12/05<br />

31/12/05<br />

14199 Vitaminum B6 Pyridoxinum (vit B6) Tablets 50 mg Polfarmex S.A 31/12/07<br />

14200 Vitaminum C Acidum ascorbicum Drops 100 mg na<br />

1ml<br />

Wrocławskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

12/10/05


EN<br />

1358 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14201 Vitaminum C Acidum ascorbicum Film-coated tablets 0,2 g Ufimskie ZakŁady<br />

Witaminowe ‘UfaWita’ S.A.,<br />

UFA<br />

14202 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

14203 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

14208 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

14209 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

14210 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

14211 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

14212 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

14213 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

14204 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

14205 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

14206 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

14207 Vitaminum C Acidum ascorbicum<br />

(vit C)<br />

Capsules, soft 100 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Capsules, soft 200 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

Film-coated tablets 200mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

Film-coated tablets Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

Film-coated tablets 100 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Film-coated tablets 100 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Film-coated tablets 200 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Film-coated tablets 200 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

Oral drops, solution 100 mg/ml Medana Pharma Terpol<br />

Group S.A.<br />

Solution for injection 100 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Solution for injection 50 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

Tablets 100 mg ARGON Zakład<br />

Farmaceutyczny Spółka<br />

Akcyjna<br />

14214 Vitaminum C Acidum ascorbicum Powder for veterinary<br />

use<br />

31/12/08<br />

12/10/05<br />

12/10/05<br />

30/11/05<br />

31/12/08<br />

30/01/05<br />

31/12/05<br />

30/01/05<br />

31/12/05<br />

7/03/07<br />

30/11/05<br />

30/11/05<br />

30/04/06<br />

Interbiowet 4/11/06<br />

14215 Vitaminum C 0,1 Acidum ascorbicum Film-coated tablets P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

14216 Vitaminum C 0,1 Acidum ascorbicum<br />

(vit C)<br />

14217 Vitaminum C 0,1 Acidum ascorbicum<br />

(vit C)<br />

Film-coated tablets 100 mg AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

21/03/07<br />

Film-coated tablets 100 mg Polfarmex S.A 30/06/06<br />

14218 Vitaminum C 0,2 Acidum ascorbicum Film-coated tablets P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

14219 Vitaminum C 0,2 Acidum ascorbicum<br />

(vit C)<br />

14220 Vitaminum C 0,2 Acidum ascorbicum<br />

(vit C)<br />

14221 Vitaminum C 0,5 Acidum ascorbicum<br />

(vit C)<br />

14222 Vitaminum C 0,5 Acidum ascorbicum<br />

(vit C)<br />

14223 Vitaminum C 0,5 Acidum ascorbicum<br />

(vit C)<br />

Film-coated tablets 200 mg AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

28/02/06<br />

Film-coated tablets 200 mg Polfarmex S.A 30/06/06<br />

Effervescent powder 500 mg AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

Effervescent powder 500 mg AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

Effervescent powder 500 mg AFLOFARM Fabryka Leków<br />

Sp. z o.o.<br />

14224 Vitaminum C 10 % Inj. Acidum ascorbicum Solution for veterinary<br />

use<br />

31/01/06<br />

31/01/06<br />

31/01/06<br />

Biowet Puławy Sp. z o.o. 14/02/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1359<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14225 Vitaminum C 100 Acidum ascorbicum<br />

(vit C)<br />

14226 Vitaminum C 200 Acidum ascorbicum<br />

(vit C)<br />

Buccal tablet 100 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

Buccal tablet 200 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

14<strong>227</strong> Vitaminum C 5 % Inj. Acidum ascorbicum Solution for veterinary<br />

use<br />

14228 Vitaminum C 500 Acidum ascorbicum<br />

(vit C)<br />

14229 Vitaminum C forte effervescens Acidum ascorbicum<br />

(vit C)<br />

14230 Vitaminum C-0,1 Acidum ascorbicum<br />

(vit C)<br />

14231 Vitaminum C-0,2 Acidum ascorbicum<br />

(vit C)<br />

30/06/06<br />

30/06/06<br />

Biowet Puławy 7/02/05<br />

Buccal tablet 500 mg Grodziskie Zakłady<br />

Farmaceutyczne POLFA<br />

30/06/06<br />

Effervescent powder 0.5 g/4 g Polfarmex S.A 30/09/07<br />

Film-coated tablets 100 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

Film-coated tablets 200 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

14232 Vitaminum D 1000 Colecalciferolum Tablets 1000 j.m. =<br />

0,0250 mg<br />

14233 Vitaminum D 500 Colecalciferolum Tablets 500 j.m.<br />

=0,0125 mg<br />

30/04/05<br />

30/04/05<br />

Polfarmex Sp. z o.o. 31/12/08<br />

Polfarmex Sp. z o.o. 31/12/08<br />

14234 Vitaminum D3 solutio aquosa Colecalciferolum Oral solution 15000 j.m./ml Medana Pharma Terpol<br />

Group S.A.<br />

14237 Vitaminum E Tocopherolum Capsules, hard 100 mg Medana Pharma Terpol<br />

Group S.A.<br />

31/01/06<br />

31/01/06<br />

14238 Vitaminum E Tocopherolum Capsules, hard 100 mg US Pharmacia Sp. z o.o. 31/01/05<br />

14239 Vitaminum E Tocopherolum Capsules, hard 100 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

14240 Vitaminum E Tocopherolum Capsules, hard 200 mg Synteza Sp. z o.o. —<br />

Przedsie˛biorstwo<br />

Farmaceutyczno-Chemiczne<br />

14241 Vitaminum E Tocopherolum Capsules, hard 200 mg Medana Pharma Terpol<br />

Group S.A.<br />

14242 Vitaminum E Tocopherolum Capsules, hard 300 mg Medana Pharma Terpol<br />

Group S.A.<br />

14235 Vitaminum E Tocopherolum Capsules 100mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

14236 Vitaminum E Tocopherolum Capsules 100 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

14243 Vitaminum E Tocopherolum Capsules, soft 400 mg Medana Pharma TERPOL<br />

Group S.A.<br />

14244 Vitaminum E Tocopherolum Capsules, soft 100 mg Herbapol — Wrocławskie<br />

Zakłady Zielarskie S.A.<br />

14245 Vitaminum E Tocopherolum Capsules, soft 200 mg Gal s.c. Specjalistyczne<br />

Przedsie˛biorstwo Rolno —<br />

Przetwórcze<br />

12/10/05<br />

12/10/05<br />

23/03/05<br />

31/01/06<br />

31/12/05<br />

31/12/08<br />

31/12/08<br />

31/12/05<br />

31/12/05<br />

14249 Vitaminum E Tocopherolum Film-coated tablets 100 mg Krka d.d., Novo mesto 30/01/05<br />

14246 Vitaminum E Tocopherolum Oral drops, solution 300 mg/1 ml Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

31/12/08


EN<br />

1360 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14247 Vitaminum E Tocopherolum Solution for injection 0.3 g/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14248 Vitaminum E Tocopherolum Solution for injection 30 mg/1 ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14250 Vitaminum E Tocopherolum Solution for veterinary<br />

use<br />

Warszawskie Zakłady<br />

Farmaceutyczne Polfa<br />

14251 Vitaminum E — 100 S Tocopherolum Capsules 100 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14252 Vitaminum E — 200 S Tocopherolum Capsules 200 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14253 Vitaminum E 100 Tocopherolum Buccal tablet 100 mg Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

30/11/05<br />

30/11/05<br />

30/06/04<br />

31/12/08<br />

31/12/08<br />

29/03/06<br />

14254 Vitaminum E 100 Tocopherolum Film-coated tablets 100 mg Polfarmex S.A 14/12/05<br />

14255 Vitaminum E 200 Tocopherolum Buccal tablet 200 mg Curtis Healthcare Sp. z o.o.<br />

Przedsie˛biorstwo Handlowe,<br />

Przedsie˛biorstwo<br />

Farmaceutyków<br />

14256 VITAMINUM E 300 mg Tocopherolum Capsules, soft 300 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej ‘HASCO-<br />

LEK’<br />

14257 Vitaminum E 400 mg Tocopherolum Capsules, soft 400 mg Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

14258 Vitaminum E liquidum Tocopherolum Oral solution 0.3 g/ml Medana Pharma Terpol<br />

Group S.A.<br />

14259 Vitaminum PP Nicotinamidum Solution for injection 50 mg/ml Pliva Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

14260 Vitaminum PP Nicotinamidum Tablets 200 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

14261 Vitaminum PP Nicotinamidum Tablets 200 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

14262 Vitaminum PP Nicotinamidum Tablets 50 mg Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

14263 Vitaminum PP Nicotinamidum Tablets 50 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

29/03/06<br />

31/12/08<br />

31/07/05<br />

31/01/06<br />

30/11/05<br />

30/01/05<br />

31/12/05<br />

30/01/05<br />

31/12/05<br />

14264 Vitaminum PP Nicotinamidum Tablets 50 mg Polfarmex S.A. 30/11/05<br />

14265 Vitaminum PP Nicotinamidum Tablets 200 mg Polfarmex S.A. 30/11/05<br />

14266 Vitapil Film-coated tablets Puritan's Pride, Incorporated 31/07/04<br />

14267 Vitaral Coated tablets Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

14268 Vitaral Film-coated tablets Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

14269 Vitaral Senior Vitamins and minerals Film-coated tablets praparat<br />

złoz˙ony<br />

14270 Vitarutin Acidum ascorbicum +<br />

Rutosidum<br />

Film-coated tablets 100 mg +<br />

25 mg<br />

Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/01/06<br />

31/01/06<br />

31/12/08<br />

Elanda S.C. 31/12/08<br />

14271 Vitasan E Tocopherolum Capsules, soft 200 mg R.P. Scherer GmbH & Co. KG 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1361<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14272 Vitasol C Acidum ascorbicum Solution for veterinary<br />

use<br />

14273 Vitazol AD3E płyn Witamina A,<br />

Witamina D3,<br />

Witamina E<br />

Liquid for veterinary<br />

use<br />

14274 Vitazol AD3E inj. Witamina a, d3, e Solution for veterinary<br />

use<br />

14275 Vitazol AD3E Proszek Witaminy A, D3, E Powder for veterinary<br />

use<br />

14276 Vitazol AD3EC Witaminy C,A, D3, E Powder for veterinary<br />

use<br />

14277 Vitazol B12 inj. Cyanocobalaminum Solution for veterinary<br />

use<br />

14278 Vitazol EC Witamina E,<br />

Witamina C<br />

14279 VITIRON Suscaps Preparat witaminowo —<br />

mineralny<br />

Powder for veterinary<br />

use<br />

Richter Pharma AG 28/01/07<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

28/04/04<br />

Biowet Drwalew 31/12/08<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

5/08/04<br />

5/08/04<br />

Biowet Drwalew 31/12/08<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

28/04/04<br />

Gelatin capsules, soft MEPHA Ltd. 31/12/08<br />

14280 Vitis fix Herb Herbapol Lublin S.A. 31/12/04<br />

14281 Vitole E Tocopherolum Capsules, soft 100 j.m. Medana Pharma Terpol<br />

Group S.A.<br />

14282 Vitole E Tocopherolum Capsules, soft 200 j.m. Medana Pharma Terpol<br />

Group S.A.<br />

14283 Vitole E Tocopherolum Capsules, soft 300 j.m. Medana Pharma Terpol<br />

Group S.A.<br />

14284 Vitole E Tocopherolum Capsules, soft 400 j.m. Medana Pharma Terpol<br />

Group S.A.<br />

14285 Vitreolent Kalii iodidum + Natrii<br />

iodidum<br />

Eye drops (3mg + 3mg)/<br />

ml<br />

Novartis Ophthalmics AG<br />

Hettlingen<br />

9/08/06<br />

9/08/06<br />

9/08/06<br />

9/08/06<br />

30/06/04<br />

14286 Vitrum Film-coated tablets Unipharm Inc. 31/03/07<br />

14287 Vitrum Calcium + Vit. D3 Calcii carbonas,<br />

Colecalciferolum<br />

14288 Vitrum Calcium +<br />

Vitaminum D3<br />

Calcium zwia˛zki +<br />

Colecalciferolum<br />

Effervescent tablets 500 mg +<br />

200 j.m.<br />

UNIPHARM INC. 31/12/08<br />

Film-coated tablets Unipharm Inc. 31/03/07<br />

14289 Vitrum Cardio Film-coated tablets Unipharm Inc. 31/12/08<br />

14290 Vitrum Gastric Calcii carbonas +<br />

Magnesii hydroxydum<br />

Buccal tablets 1430 mg +<br />

122 mg<br />

UNIPHARM INC. 31/12/08<br />

14291 Vitrum Junior Preparat złoz˙ony Buccal tablets UNIPHARM INC. 31/12/08<br />

14292 Vitrum Mag Calcii carbonas,<br />

Magnesii hydroxidum<br />

14293 Vitrum Osteomag + Vit. D3 Calcii carbonas,<br />

Magnesii oxydum,<br />

Colecalciferolum<br />

Buccal tablets 500 mg Ca2+,<br />

50 mg Mg2+<br />

Film-coated tablets 600 mg Ca2+,<br />

40 mg Mg2+<br />

UNIPHARM INC. 31/12/08<br />

UNIPHARM INC. 31/12/08<br />

14294 Vitrum Performance Preparat złoz˙ony Film-coated tablets UNIPHARM INC. 31/12/08<br />

14295 Vitrum Plus Preparat złoz˙ony Effervescent tablets UNIPHARM INC. 31/12/08<br />

14296 Vitrum Plus Junior Preparat złoz˙ony Effervescent tablets UNIPHARM INC. 31/12/08


EN<br />

1362 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14297 Vitrum Plus Magnesium Magnesii oxidum Effervescent tablets 300 mg Mg2+ UNIPHARM INC. 31/12/08<br />

14298 Vitrum Prenatal Film-coated tablets Unipharm Inc. 31/03/07<br />

14299 VITRUM Prenatal Forte Preparat złoz˙ony Film-coated tablets UNIPHARM INC. 31/12/08<br />

14300 Vitrum Senior Preparat złoz˙ony Film-coated tablets UNIPHARM INC. 31/12/08<br />

14301 Vivacor Carvedilolum Tablets 12.5 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

14302 Vivacor Carvedilolum Tablets 25 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

14303 Vivacor Carvedilolum Tablets 6.25 mg Anpharm S.A.<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

14305 Vividrin Acidum cromoglicicum Eye drops, solution 20 mg/ml Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

14304 Vividrin Acidum cromoglicicum Nasal spray, solution 2.6 mg/dawke˛<br />

donosowa˛<br />

Dr Gerhard Mann Chem. —<br />

Pharm. Fabrik GmbH<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/03/07<br />

31/03/07<br />

14306 Vividrin Iso Edo Natrii cromoglicas Eye drops, solution 20 mg/ml Dr Gerhard Mann 31/12/08<br />

14311 Voltaren Diclofenacum Gastro-resistant<br />

tablets<br />

14312 Voltaren Diclofenacum Gastro-resistant<br />

tablets<br />

14310 Voltaren Diclofenacum Solution for<br />

intramuscular<br />

injection or for<br />

infusion<br />

25 mg Novartis Consumer Health<br />

S.A.<br />

31/05/05<br />

50 mg Novartis Pharma AG 31/05/05<br />

25 mg/ml Novartis Pharma AG 31/05/05<br />

14307 Voltaren Diclofenacum Suppository 100 mg Novartis Pharma AG 31/05/05<br />

14308 Voltaren Diclofenacum Suppository 25 mg Novartis Pharma AG 31/05/05<br />

14309 Voltaren Diclofenacum Suppository 50 mg Novartis Pharma AG 31/05/05<br />

14313 Voltaren Acti Diclofenacum Film-coated tablets 12.5 mg Novartis Consumer Health<br />

S.A.<br />

14314 Voltaren Emulgel 1 % Diclofenacum Gel 10 mg/g Novartis Consumer Health<br />

S.A.<br />

14315 Voltaren SR 100 Diclofenacum Prolonged release<br />

tablets<br />

14316 Voltaren SR 75 Diclofenacum Prolonged release<br />

tablets<br />

27/06/07<br />

31/05/04<br />

100 mg Novartis Pharma AG 31/05/04<br />

75 mg Novartis Pharma AG 1/04/06<br />

14317 Voltenac Diclofenacum Gel 10 mg/g Sanofi-Synthelabo Sp. z o.o. 31/01/05<br />

14318 Vomitusheel Drops Heel GmbH 31/12/08<br />

14319 Vomitusheel S Suppository Heel GmbH 31/12/08<br />

14320 Voxpax Tablets Lehning Laboratoires 31/03/06<br />

14321 Vratizolin Denotivirum Cream 30 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

14322 Vratizolin Denotivirum Eye suspension 20 mg/g Jelfa S.A. Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/10/05<br />

31/12/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1363<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14323 Vulketan Ketanseryny winian Gel for veterinary<br />

use<br />

Janssen Pharmaceutica N.V. 24/11/04<br />

14324 Vumon Teniposidum Solution for injection 10 mg/ml Bristol-Myers Squibb S.p.A,<br />

Latina<br />

30/06/04<br />

14325 Vupral Acidum valproicum Oral drops 200 mg/ml ICN Polfa Rzeszów S.A. 31/12/05<br />

14326 Wagavit Capsules Bional BV 31/12/08<br />

14327 Wagavit Capsules Bional Pharma BV 31/12/08<br />

14328 Waleriana na Dzień Tablets Vitamex AB 31/07/04<br />

14329 Waleriana na Noc Tablets Vitamex AB 31/07/04<br />

14330 Walerianki Tablets 0.5 g Laboratorium<br />

Farmaceutyczne mgr farm.<br />

Zofia Sadowska<br />

14331 Wamag Calcii glubionas + Calcii<br />

lactas + Magnesii lactas<br />

Syrup Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

31/12/08<br />

31/01/06<br />

14332 Wapnia bromek Pharma Cosmetic, Kraków 24/11/05<br />

14333 Wapnia bromek Pharma Zentrale 24/11/05<br />

14334 Wapnia bromek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

24/11/05<br />

14335 Wapnia chlorek Biochem, Warszawa 30/11/05<br />

14336 Wapnia chlorek Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

30/11/05<br />

14337 Wapnia chlorek Pharma Cosmetic, Kraków 30/11/05<br />

14338 Wapnia chlorek Pharma Zentrale 30/11/05<br />

14339 Wapnia chlorek Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

14340 Wapnia chlorek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

30/11/05<br />

30/11/05<br />

14341 Wapnia glukonian Pharma Cosmetic, Kraków 31/12/08<br />

14342 Wapnia glukonian Pharma Zentrale 31/12/08<br />

14343 Wapnia glukonian PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

14344 Wapnia mleczan Pharma Cosmetic, Kraków 31/12/08<br />

14345 Wapnia mleczan Pharma Zentrale 31/12/08<br />

14346 Wapnia mleczan PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/12/08<br />

14347 Wapnia tlenek Pharma Zentrale 31/01/05<br />

14348 Wapnia tlenek PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

31/01/05<br />

14349 Wapnia we˛glan stra˛cony Cefarm Gdańsk 14/06/07<br />

14350 Wapnia we˛glan stra˛cony Cefarm Wrocław 14/06/07<br />

14351 Wapnia we˛glan stra˛cony Farm-Impex s.j., Gliwice 14/06/07


EN<br />

1364 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14352 Wapnia we˛glan stra˛cony Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

14353 Wapnia we˛glan stra˛cony Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

14/06/07<br />

14/06/07<br />

14354 Wapnia we˛glan stra˛cony Pampa, Piaseczno 14/06/07<br />

14355 Wapnia we˛glan stra˛cony Pharma Cosmetic, Kraków 14/06/07<br />

14356 Wapnia we˛glan stra˛cony Pharma Zentrale 14/06/07<br />

14357 Wapnia we˛glan stra˛cony Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

14358 Wapnia we˛glan stra˛cony PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

14359 Wapnia we˛glan stra˛cony Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

14360 Wapnia wodorofosforan Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

14361 Wapnia wodorowe˛glan BUFA b.v. Pharmaceutical<br />

Products<br />

14362 Wapno sodowane Calcii hydroxydum cum Natrii hydroxydo<br />

granulatum<br />

14/06/07<br />

14/06/07<br />

14/06/07<br />

30/09/05<br />

4/03/05<br />

Firma Chemiczna Dwory S.A. 19/06/05<br />

14363 Wartec Podophyllotoxinum Cream 1.5 mg/g Stiefel Laboratories (UK) Ltd. 23/11/05<br />

14364 Wartec — Wolff Podophyllotoxinum Liquid 5 mg/ml Dr August Wolff GmbH &<br />

Co.<br />

31/12/08<br />

14365 Wastan Atorvastatinum Film-coated tablets 10 mg Instytut Farmaceutyczny 31/12/08<br />

14366 Wastan Atorvastatinum Film-coated tablets 20 mg Instytut Farmaceutyczny 31/12/08<br />

14367 Wastan Atorvastatinum Film-coated tablets 40 mg Instytut Farmaceutyczny 31/12/08<br />

14368 Wazelina biała Vaselinum album Aflofarm Farmacja Polska,<br />

Pabianice<br />

19/01/05<br />

14369 Wazelina biała Vaselinum album AUGMED, Dawidy Bankowe 19/01/05<br />

14370 Wazelina biała Vaselinum album Avena, Bydgoszcz 19/01/05<br />

14371 Wazelina biała Vaselinum album Cefarm Cze˛stochowa 19/01/05<br />

14372 Wazelina biała Vaselinum album Cefarm Gdańsk 19/01/05<br />

14373 Wazelina biała Vaselinum album Farmina Sp. z o.o., Kraków 19/01/05<br />

14374 Wazelina biała Vaselinum album Hasco-Lek, Wrocław 19/01/05<br />

14375 Wazelina biała Vaselinum album Laboratorium<br />

Farmaceutyczne<br />

HOMEOFARM Sp. z o.o.<br />

14376 Wazelina biała Vaselinum album Laboratorium<br />

Farmaceutyczne<br />

HOMEOFARM Sp. z o.o.<br />

14377 Wazelina biała Vaselinum album Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

19/01/05<br />

19/01/05<br />

19/01/05<br />

14378 Wazelina biała Vaselinum album Lefarm, Bydgoszcz 19/01/05<br />

14379 Wazelina biała Vaselinum album Maggie, Warszawa 19/01/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1365<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14380 Wazelina biała Vaselinum album Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

19/01/05<br />

14381 Wazelina biała Vaselinum album Pampa, Piaseczno 19/01/05<br />

14382 Wazelina biała Vaselinum album Pharma Cosmetic, Kraków 19/01/05<br />

14383 Wazelina biała Vaselinum album Pharma Zentrale 19/01/05<br />

14384 Wazelina biała Vaselinum album PPF GEMI, Karczew 19/01/05<br />

14385 Wazelina biała Vaselinum album PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

19/01/05<br />

14386 Wazelina biała Vaselinum album PZF ‘Cefarm-Lublin’ S.A. 19/01/05<br />

14387 Wazelina biała Vaselinum album Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

19/01/05<br />

14388 Wazelina biała Vaselinum album Ziaja, Gdańsk 19/01/05<br />

14389 Wazelina hydrofilowa Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

19/10/07<br />

14390 Wazelina hydrofilowa Ziaja, Gdańsk 19/10/07<br />

14391 Wazelina z˙ółta Vaselinum flavum Aflofarm Farmacja Polska,<br />

Pabianice<br />

5/08/05<br />

14392 Wazelina z˙ółta Vaselinum flavum Hasco-Lek, Wrocław 5/08/05<br />

14393 Wazelina z˙ółta Vaselinum flavum Laboratorium<br />

Farmaceutyczne<br />

HOMEOFARM Sp. z o.o.<br />

14394 Wazelina z˙ółta Vaselinum flavum Laboratorium Galenowe<br />

Olsztyn Sp. z o.o.<br />

5/08/05<br />

5/08/05<br />

14395 Wazelina z˙ółta Vaselinum flavum Lefarm, Bydgoszcz 5/08/05<br />

14396 Wazelina z˙ółta Vaselinum flavum Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

5/08/05<br />

14397 Wazelina z˙ółta Vaselinum flavum Pharma Cosmetic, Kraków 5/08/05<br />

14398 Wazelina z˙ółta Vaselinum flavum Pharma Zentrale 5/08/05<br />

14399 Wazelina z˙ółta Vaselinum flavum PPF GEMI, Karczew 5/08/05<br />

14400 Wazelina z˙ółta Vaselinum flavum PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

5/08/05<br />

14401 Wazelina z˙ółta Vaselinum flavum PZF ‘Cefarm-Lublin’ S.A. 5/08/05<br />

14402 Wazelina z˙ółta Vaselinum flavum Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

14403 Wellbutrin Sr Bupropionum Film-coated,<br />

prolonged release<br />

tablets<br />

150 mg Glaxo Wellcome House,<br />

Glaxo Wellcome Group<br />

5/08/05<br />

31/12/08<br />

14404 Wenlafaksyna Er Venlafaxinum Capsules 75 mg POLFA KUTNO S.A. 31/12/08<br />

14405 Wenlafaksyna Er Venlafaxinum Capsules 150 mg POLFA KUTNO S.A. 31/12/08


EN<br />

1366 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14406 Werten Acidum ascorbicum,<br />

Rutosidum,<br />

Tocopherolum<br />

14407 Wetacyklina Tetracykliny<br />

chlorowodorek<br />

14408 Wetastymina Ekstrakt z tkanek<br />

wa˛troby i s´ledziony<br />

zdrowych s´wiń<br />

Film-coated tablets (200 + 200 +<br />

50) mg<br />

Intrauterine stick for veterinary<br />

use<br />

Liquid for veterinary<br />

use<br />

Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

Drwalewskie Zakłady<br />

Przemysłu<br />

Bioweterynaryjnego<br />

31/12/08<br />

13/09/04<br />

Biowet Puławy Sp. z o.o. 27/11/05<br />

14409 We˛giel leczniczy Carbo medicinalis Capsules 200 mg Aflofarm Fabryka Leków,<br />

Ksawerów<br />

14410 We˛giel leczniczy Carbo medicinalis Capsules 200 mg Aflofarm Fabryka Leków,<br />

Ksawerów<br />

14411 We˛giel leczniczy Carbo medicinalis Capsules 200 mg Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

14412 We˛giel leczniczy Carbo medicinalis Capsules 200 mg Zakład Farmaceutyczny<br />

Amara, Kraków<br />

24/05/07<br />

24/05/07<br />

24/05/07<br />

24/05/07<br />

14413 We˛giel leczniczy Carbo medicinalis Capsules 200 mg ICN Polfa Rzeszów 24/05/07<br />

14414 We˛giel leczniczy Carbo medicinalis BUFA b.v. Pharmaceutical<br />

Products<br />

24/05/07<br />

14415 We˛giel leczniczy Carbo medicinalis Pharma Cosmetic, Kraków 24/05/07<br />

14416 We˛giel leczniczy Carbo medicinalis Pharma Zentrale 24/05/07<br />

14417 We˛giel Leczniczy Wegiel leczniczy Powder for veterinary<br />

use<br />

14418 We˛giel leczniczy NORIT<br />

200 mg<br />

PFO Vetos-Farma 15/05/07<br />

Carbo medicinalis Norit 31/12/05<br />

14419 We˛glan Wapnia Stra˛cony Calcii carbonas Capsules, hard 200 mg Ca2+ Laboratorium Galenowe<br />

‘LEFARM’ Sp. z o.o.<br />

14420 We˛glan Wapnia Stra˛cony Calcii carbonas Capsules, hard 400 mg Ca2+ Laboratorium Galenowe<br />

‘LEFARM’ Sp. z o.o.<br />

14421 Wick Formula 44 Plus L Guaifenesinum Syrup 200 mg/15ml Procter & Gamble Operations<br />

GmbH & Co. Manufacturing<br />

OHG<br />

14422 Wick Formula 44 Plus S Dextromethorphanum Syrup 20 mg/15 ml Procter & Gamble Operations<br />

GmbH & Co. Manufacturing<br />

OHG<br />

14423 Wick Vapo Rub Ointment Procter & Gamble Operations<br />

GmbH & Co. Manufacturing<br />

OHG<br />

31/12/08<br />

31/12/08<br />

31/07/04<br />

31/07/04<br />

30/04/04<br />

14424 Wick vapo sirup Wick Pharma 31/12/08<br />

14425 Wielka Pieniawa Preparat złoz˙ony Mineral medicated<br />

water<br />

Zespół Uzdrowisk Kłodzkich<br />

S.A.<br />

14426 Wincoram Amrinonum Solution for injection 5 mg/ml Sanofi Winthrop-Gentilly<br />

Cedex<br />

14427 Winian sodowo-potasowy Polskie Odczynniki<br />

Chemiczne, Gliwice<br />

30/09/07<br />

30/06/04<br />

30/09/05


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1367<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14428 WinRho SDF Anti-D (rh)<br />

immunoglobulinum<br />

14429 Witagin Ginseng radix extractum<br />

siccum<br />

Powder and solvent<br />

for solution for<br />

intramuscular or<br />

intravenous injection<br />

1500 j.m.<br />

(300 mcg)<br />

Cangene Corporation 16/07/06<br />

Tablets 60 mg Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

31/12/08<br />

14430 Witamina A +D3 naturalna Olej z wa˛troby halibuta Capsule, soft 165 mg Agropharm S.A. 31/12/08<br />

14431 Witamina AD3E 80/40/20<br />

pro.inj.<br />

Palmitynian retynolu,<br />

Cholekalcyferol, Octan<br />

a-tokoferolu<br />

Solution for veterinary<br />

use<br />

Vetimex Animal Health B.V. 16/12/04<br />

14432 Witamina B Complex Preparat złoz˙ony Capsules Healthilife Limited 31/12/08<br />

14433 Witamina C Acidum ascorbicum<br />

(vit C)<br />

Effervescent tablets 1000 mg Pharmavit Kft. 31/03/07<br />

14434 Witamina C Effervescent powder 500 mg Farmina Sp. z o.o. 31/03/07<br />

14435 Witamina C Acidum ascorbicum Powder for veterinary<br />

use<br />

14436 Witamina C + Glukoza Witamina C, Glukoza Powder for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

31/12/08<br />

1/08/04<br />

14438 Witamina C 500 Acidum ascorbicum Chewable tablets 500 mg Healthilife Limited 31/12/08<br />

14437 Witamina C 500 Acidum ascorbicum Tablets Sun — Farm Sp. z o.o. 31/12/08<br />

14439 Witamina E Tocopherolum Capsules 335 mg Healthilife Limited 31/12/08<br />

14440 Witamina E forte Tocopherolum Capsules 147 mg Queisser Pharma GmbH & Co 31/08/04<br />

14441 WITAMINA E Naturalna NS Tocopherolum Capsules, hard 100 j.m. Agropharm S.A. 31/12/08<br />

14442 Witaminum A 30000 + E70 Retinolum +<br />

Tocopherolum<br />

14443 Witaminy dla Dzieci Multivitamins and trace<br />

elements<br />

14444 Witkarnit Witamina a, b1,b2,b6,<br />

b12, e,k3, pp, biotyna,<br />

cholina, L-karnityna<br />

Gelatin capsules, soft 30000 j.m. +<br />

70mg<br />

Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Hasco-Lek<br />

30/04/06<br />

Tablets Vitamex AB 31/07/04<br />

Liquid for veterinary<br />

use<br />

Biowet Puławy 31/12/08<br />

14445 Woda demineralizowana Maggie, Warszawa 5/03/05<br />

14446 Woda do przepłukiwania Aqua pro irrygatione Aqua for rinse Baxter Terpol Sp. z o.o. 7/03/07<br />

14447 Woda Do Wstrzykiwań Aqua pro injectione Solvent for parenteral<br />

use<br />

14448 Woda do wstrzyknie˛ć Aqua pro injectione Solvent for parenteral<br />

use<br />

100 ml,<br />

250 ml,<br />

500 ml<br />

Fresenius Kabi Polska Sp.<br />

z o.o.<br />

30/09/07<br />

B. Braun Melsungen AG 17/01/07<br />

14449 Woda oczyszczona Felix Pharma, Lublin 15/04/06<br />

14450 Woda oczyszczona Galenus, Rzeszów 15/04/06<br />

14451 Woda oczyszczona Labpharm-ATS, Brwinów 15/04/06<br />

14452 Woda oczyszczona Prolab, Paterek k/Nakła 15/04/06<br />

14453 Woda oczyszczona PZF ‘Cefarm-Lublin’ S.A. 15/04/06<br />

14454 Woda utleniona Nadtlenek wodoru Liquid for veterinary<br />

use<br />

Galvet 31/12/08


EN<br />

1368 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14455 Woda utleniona ANNA, Nowa De˛ba 31/12/05<br />

14456 Woda utleniona Cefarm Cze˛stochowa 31/12/05<br />

14457 Woda utleniona Labpharm-ATS, Brwinów 31/12/05<br />

14458 Woda utleniona PPF GEMI, Karczew 31/12/05<br />

14459 Woda utleniona 3 % nadtlenek wodoru Liquid for veterinary<br />

use<br />

Felix Pharma 31/12/08<br />

14460 Woda utleniona 3 % AUGMED, Dawidy Bankowe 31/12/08<br />

14461 Woda utleniona 3 % Avena, Bydgoszcz 31/12/08<br />

14462 Woda utleniona 3 % Cefarm Gdańsk 31/12/08<br />

14463 Woda utleniona 3 % Felix-Pharma, Lublin 31/12/08<br />

14464 Woda utleniona 3 % Hasco-Lek, Wrocław 31/12/08<br />

14465 Woda utleniona 3 % Ichem, Łódz´ 31/12/08<br />

14466 Woda utleniona 3 % Infarm, Gdynia 31/12/08<br />

14467 Woda utleniona 3 % Lefarm, Bydgoszcz 31/12/08<br />

14468 Woda utleniona 3 % Maggie, Warszawa 31/12/08<br />

14469 Woda utleniona 3 % Małgorzata Kacperska, Jan<br />

Kacperski Przedsie˛biorstwo<br />

Produkcyjno-Handlowe<br />

MICROFARM s.c.<br />

31/12/08<br />

14470 Woda utleniona 3 % Polon, Łódz´ 31/12/08<br />

14471 Woda utleniona 3 % PZF ‘Cefarm-Lublin’ S.A. 31/12/08<br />

14472 Woda utleniona 3 % Septoma, Za˛bki 31/12/08<br />

14473 Woda utleniona 3 % Zakład Farmaceutyczny<br />

Amara, Kraków<br />

31/12/08<br />

14474 Woda wapienna Maga-Herba s.c., Legionowo 28/02/06<br />

14475 Woda wapienna Pharma Cosmetic, Kraków 28/02/06<br />

14476 Woda wapienna Pharma Zentrale 28/02/06<br />

14477 Woda wapienna PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

14478 Woda wapienna Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

14479 Woda wapienna Zakład Farmaceutyczny<br />

Amara, Kraków<br />

14480 Wodny Roztwór Fioletu<br />

Gencjanowego 1 %<br />

14481 Wodny Roztwór Fioletu<br />

Gencjanowego 2 %<br />

Methylrosanilinii<br />

chloridum<br />

Methylrosanilinii<br />

chloridum<br />

Coutanous liquid 10 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

Coutanous liquid 20 mg/g Przedsie˛biorstwo Produkcji<br />

Farmaceutycznej Gemi<br />

28/02/06<br />

28/02/06<br />

28/02/06<br />

30/01/05<br />

30/01/05<br />

14482 Wodorowe˛glan sodu Cefarm Gdańsk 12/10/05<br />

14483 Wodorowe˛glan sodu PZF ‘Cefarm-Lublin’ S.A. 12/10/05<br />

14484 Wodoru nadtlenek 3 % Hydrogenii peroxydum Aflofarm Farmacja Polska,<br />

Pabianice<br />

24/03/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1369<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14485 Wodoru nadtlenek 3 % Hydrogenii peroxydum Eko-Lek, Łabowa 24/03/06<br />

14486 Wodoru nadtlenek 3 % Hydrogenii peroxydum Farmina Sp. z o.o., Kraków 24/03/06<br />

14487 Wodoru nadtlenek 3 % Hydrogenii peroxydum Filofarm, Bydgoszcz 24/03/06<br />

14488 Wodoru nadtlenek 3 % Hydrogenii peroxydum Laboratorium<br />

Farmaceutyczne Jarosław<br />

Szczepańczyk<br />

24/03/06<br />

14489 Wodoru nadtlenek 3 % Hydrogenii peroxydum Polfarmex, Kutno 24/03/06<br />

14490 Wodoru nadtlenek 3 % Hydrogenii peroxydum Prolab, Paterek k/Nakła 24/03/06<br />

14491 Wodoru nadtlenek 3 % Hydrogenii peroxydum Res-Farm., Rzeszów 24/03/06<br />

14492 Wodoru nadtlenek 3 % Hydrogenii peroxydum Semifarm, Gdańsk 24/03/06<br />

14493 Wodoru nadtlenek 3 % Hydrogenii peroxydum Wytwórnia Euceryny<br />

Laboratorium<br />

Farmaceutyczne Coel, Kraków<br />

14494 Wodoru nadtlenek 3 %<br />

(Hydrogenii peroxydum 3 %)<br />

24/03/06<br />

Hydrogenii peroxydum Herbapol Kraków 4/03/07<br />

14495 Wodoru nadtlenek 30 % Hydrogenii peroxydum Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/01/06<br />

14496 Wodoru nadtlenek 30 % Hydrogenii peroxydum Cefarm Cze˛stochowa 31/01/06<br />

14497 Wodoru nadtlenek 30 % Hydrogenii peroxydum Maga-Herba s.c., Legionowo 31/01/06<br />

14498 Wodoru nadtlenek 30 % Hydrogenii peroxydum Pharma Zentrale 31/01/06<br />

14499 Wodoru nadtlenek 30 % Hydrogenii peroxydum Zakład Farmaceutyczny<br />

Amara, Kraków<br />

14500 Wolff Basis Preparat złoz˙ony Cutaneous emulsion Dr August Wolff GmbH &<br />

Co.<br />

31/01/06<br />

31/08/05<br />

14501 Woodwards Gripe Water Preparat złoz˙ony Oral solution Seton Products Ltd 30/06/04<br />

14502 Wosk biały BUFA b.v. Pharmaceutical<br />

Products<br />

30/04/06<br />

14503 Wosk biały Pharma Cosmetic, Kraków 30/04/06<br />

14504 Wosk biały Pharma Zentrale 30/04/06<br />

14505 Wosk biały PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

14506 Wosk z˙ółty BUFA b.v. Pharmaceutical<br />

Products<br />

30/04/06<br />

30/04/06<br />

14507 Wosk z˙ółty Pharma Cosmetic, Kraków 30/04/06<br />

14508 Wosk z˙ółty Pharma Zentrale 30/04/06<br />

14509 Wosk z˙ółty PPH Galfarm Sp. z o.o.,<br />

Kraków<br />

14510 Wybielacz optyczny Błe˛kit metylenowy,<br />

dwusodowy wersenian<br />

14511 Wybielacz optyczny Forte Błe˛kit metylenowy,<br />

EDTA sól dwusodowa<br />

Solution for veterinary<br />

use<br />

Solution for veterinary<br />

use<br />

30/04/06<br />

Przedsie˛biorstwo Tropical 31/12/08<br />

Przedsie˛biorstwo Tropical 18/09/07<br />

14512 Wycia˛g lukrecjowy suchy Pharma Zentrale 9/04/05<br />

14513 Wycia˛g lukrecjowy suchy Phytopharm Kle˛ka S.A. 9/04/05


EN<br />

1370 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14514 Wycia˛g tymiankowy płynny Aflofarm Farmacja Polska,<br />

Pabianice<br />

31/05/05<br />

14515 Wycia˛g z lis´ci pokrzyku suchy A.C.E.F, Włochy 31/12/08<br />

14516 Wycia˛g ze Skrzypu Polnego z<br />

Witaminami<br />

14517 Xalacom Latanoprostum +<br />

Timololum<br />

Preparat ziołowy Tablets Vitamex AB 31/07/04<br />

Eye drops (0,05 mg +<br />

5 mg)/ml<br />

PHARMACIA AB 31/12/08<br />

14518 Xalatan Latanoprostum Eye drops, solution 0.05 mg/g Pharmacia N.V./S.A. 31/05/04<br />

14519 Xanax Alprazolamum Tablets 0.25 mg Pharmacia N.V./S.A. 30/04/04<br />

14520 Xanax Alprazolamum Tablets 0.5 mg Pharmacia N.V./S.A. 30/04/04<br />

14521 Xanax Alprazolamum Tablets 1 mg Pharmacia N.V./S.A. 30/04/04<br />

14522 Xanax Alprazolamum Tablets 2 mg Pharmacia N.V./S.A. 30/04/04<br />

14523 Xanax SR Alprazolamum Prolonged release<br />

tablets<br />

14524 Xanax SR Alprazolamum Prolonged release<br />

tablets<br />

14525 Xanax SR Alprazolamum Prolonged release<br />

tablets<br />

14526 Xanax SR Alprazolamum Prolonged release<br />

tablets<br />

0.5 mg Pharmacia N.V./S.A. 31/12/08<br />

1 mg Pharmacia N.V./S.A. 31/12/08<br />

2 mg Pharmacia N.V./S.A. 31/12/08<br />

3 mg Pharmacia N.V./S.A. 31/12/08<br />

14527 Xartan Losartanum Film-coated tablets 50 mg Adamed Sp. z o.o. 30/04/05<br />

14528 Xefo Lornoxicamum Powder for injection 8 mg/2ml Nycomed A GmbH 31/12/08<br />

14529 Xefo Lornoxicamum Tablets 4 mg Nycomed A GmbH 31/12/08<br />

14530 Xefo Lornoxicamum Tablets 8 mg Nycomed A GmbH 31/12/08<br />

14531 Xeloda Capecitabinum Film-coated tablets 150 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

14532 Xeloda Capecitabinum Film-coated tablets 500 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

14533 Xenical Orlistatum Capsules 120 mg Hoffmann La Roche Ltd.<br />

Bazylea<br />

14534 Xenistat Orlistatum Tablets 120 mg Przedsie˛biorstwo<br />

Farmaceutyczne ‘LEK — AM’<br />

Sp. z o.o.<br />

14535 Xenna Sennae folium extractum<br />

siccum<br />

14536 Xenna Sennae fructus +<br />

Sennosides<br />

14537 Xenna Extra Sennae fructus +<br />

Sennosides<br />

14538 Xigris Drotrecogin alfa<br />

(aktywowany)<br />

14539 Xigris Drotrecogin alfa<br />

(aktywowany)<br />

Tablets 217 mg US Pharmacia International<br />

Inc.<br />

Tablets 8.6 mg US Pharmacia International<br />

Inc.<br />

Tablets 17 mg US Pharmacia International<br />

Inc.<br />

Powder for solution<br />

for intravenous<br />

infusion<br />

Powder for solution<br />

for intravenous<br />

infusion<br />

5 mg Eli Lilly Company<br />

Indianapolis<br />

20 mg Eli Lilly Company<br />

Indianapolis<br />

21/06/06<br />

21/06/06<br />

31/07/04<br />

31/12/08<br />

31/07/04<br />

14/12/05<br />

14/12/05<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1371<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14540 Xitrocin Roxithromycinum Film-coated tablets 50 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

14541 Xitrocin Roxithromycinum Film-coated tablets 100 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

14542 Xitrocin Roxithromycinum Film-coated tablets 150 mg Pabianickie Zakłady<br />

Farmaceutyczne ‘POLFA’<br />

14543 Xorim Cefuroximum Powder for solution<br />

for injection<br />

14544 Xorim Cefuroximum Powder for solution<br />

or suspension for<br />

injection<br />

30/09/07<br />

30/09/07<br />

30/09/07<br />

1,5 g Biochemie GmbH 31/12/08<br />

750 mg Biochemie GmbH 31/12/08<br />

14545 Xorovir Aciclovirum Cream 50 mg/g F.Joh.Kwizda GmbH 26/04/06<br />

14546 Xorovir Aciclovirum Eye ointment 30 mg/g F.Joh.Kwizda GmbH 26/04/06<br />

14547 Xorovir Aciclovirum Powder for solution<br />

for infusion<br />

250 mg F.Joh.Kwizda GmbH 26/04/06<br />

14548 Xorovir Aciclovirum Tablets 200 mg F.Joh.Kwizda GmbH 26/04/06<br />

14549 Xorovir Aciclovirum Tablets 400 mg F.Joh.Kwizda GmbH 26/04/06<br />

14550 Xorovir Aciclovirum Tablets 800 mg F.Joh.Kwizda GmbH 26/04/06<br />

14551 XP Analog Dieta w fenyloketonurii Powder for oral<br />

solution<br />

SHS International Ltd. 31/12/08<br />

14552 Xp Analog Lcp Preparat dietetyczny Powder SHS International Ltd. 31/12/08<br />

14553 X-Prep Oral solution Mundipharma Medical<br />

Company<br />

14554 Xylapan Ksylazyna Solution for veterinary<br />

use<br />

14555 XylaRiem 2 % Ksylazyny<br />

chlorowodorek<br />

Solution for veterinary<br />

use<br />

14556 Xylavet 2 % Ksylazyna Solution for veterinary<br />

use<br />

14557 Xylestesin A Epinephrinum +<br />

Lidocainum<br />

31/07/04<br />

Vetoquinol S.A. 10/07/06<br />

Rimser Arzneimittel GmbH 24/05/07<br />

Alfasan 18/03/04<br />

Solution for injection ESPE Dental AG 30/06/04<br />

14558 Xylocaine 10 % pump spray Lidocainum Mucosa spray 10 mg/dawke˛ AstraZeneca AB 30/06/04<br />

14559 Xylocaine 2 % Lidocainum Solution for injection 20 mg/ml AstraZeneca AB 30/06/04<br />

14560 Xylocaine 4 % Lidocainum Mucosa solution 40 mg/ml AstraZeneca AB 30/06/04<br />

14561 Xylodont 2 % Lidocainum Solution for injection 20 mg/ml L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

14562 Xylodont 2 % z adrenalina˛<br />

1:50.000<br />

14563 Xylodont 2 % z adrenalina˛<br />

1:80.000<br />

14564 Xylodont 2 % z adrenalina˛<br />

1:100.000<br />

Epinephrinum +<br />

Lidocainum<br />

Epinephrinum +<br />

Lidocainum<br />

Epinephrinum +<br />

Lidocainum<br />

Solution for injection (0,02mg +<br />

20mg)/ml<br />

Solution for injection (0,0125mg +<br />

20mg)/ml<br />

Solution for injection (0,01mg +<br />

20mg)/ml<br />

L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

L.Molteni & dei Elii Alitti<br />

Societa di Escercizio S.p.A.<br />

14565 Xylogel 0,05 % Xylometazolinum Nasal gel 0.5 mg/g Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14566 Xylogel 0,1 % Xylometazolinum Nasal gel 1 mg/g Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/07/04<br />

31/07/04<br />

31/07/04<br />

31/07/04<br />

30/01/05<br />

30/01/05


EN<br />

1372 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14567 Xylometazolin Xylometazolinum Nasal drops 0.1 % ICN Polfa Rzeszów S.A. 31/12/08<br />

14568 Xylometazolin 0,05 % Xylometazolinum Nasal drops 0.05 % ICN Polfa Rzeszów S.A. 31/12/08<br />

14569 Xylometazolin 0,05 % Xylometazolinum Nasal drops, solution 0.5 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14570 Xylometazolin 0,1 % Xylometazolinum Nasal drops, solution 1 mg/ml Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14571 Xylonor 2 % Noradrenaline Lidocainum +<br />

Norepinephrinum<br />

14572 Xylonor 2 % Special Lidocainum +<br />

Norepinephrinum<br />

14573 Xylonor 3 % Noradrenaline Lidocainum +<br />

Norepinephrinum<br />

Solution for injection (20mg +<br />

0,04mg)/ml<br />

Solution for injection (20mg +<br />

0,0125mg)/ml<br />

Solution for injection (30mg +<br />

0,04mg)/ml<br />

31/12/05<br />

31/12/05<br />

Septodont 31/03/05<br />

Septodont 31/03/05<br />

Septodont 30/11/04<br />

14575 Xylorhin Xylometazolinum Nasal gel 0.05 % GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

14576 Xylorhin Xylometazolinum Nasal gel 0.1 % GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

14574 Xylorhin Xylometazolinum Nasal spray 550 mcg/ml GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

14577 Xyzal Levocetirizini<br />

dihydrochloridum<br />

14578 Yasmin Drospirenonum +<br />

Ethinylstradiolum<br />

31/12/05<br />

31/12/04<br />

31/12/05<br />

Film-coated tablets 5 mg UCB Farchim S.A. 6/12/06<br />

Film-coated tablets Schering AG 31/12/08<br />

14579 Yasnal Donepezilum Film-coated tablets 5 mg KRKA d.d., Novo mesto 31/12/08<br />

14580 Yasnal Donepezilum Film-coated tablets 10 mg KRKA d.d., Novo mesto 31/12/08<br />

14581 Yersi-Fishvax Szczepionka przeciw<br />

jersiniozie pstra˛gów i<br />

innych ryb<br />

łososiowatych<br />

Liquid for veterinary<br />

use<br />

FATRO 27/03/05<br />

14582 Yewtaxan Paclitaxelum Amp. 6 mg/ml Yew Tree Pharmaceutical 31/12/08<br />

14583 Yohimbinum hydrochloricum<br />

D4<br />

Kosmed II, Głubczyce 31/12/08<br />

14584 Ypsiloheel N Tablets Heel GmbH 31/12/07<br />

14585 Yucca Complexe Lehning<br />

nr 110<br />

Drops Lehning Laboratoires 11/11/06<br />

14586 Zaart 25 Losartanum Tablets 25 mg Cipla Ltd. 31/12/08<br />

14587 Zaart 50 Losartanum Tablets 50 mg Cipla Ltd. 31/12/08<br />

14588 Zaditen Ketotifenum Eye drops, solution 0,25 mg/ml Novartis Ophthalmics AG 14/02/07<br />

14589 Zaditen Ketotifenum Eye drops, solution 0.5 mg/ml Novartis Ophthalmics AG<br />

Hettlingen<br />

14/02/07<br />

14590 Zaditen Ketotifenum Syrup 1 mg/5 ml Novartis Pharma AG 31/05/04<br />

14591 Zaditen Ketotifenum Tablets 1 mg Novartis Pharma AG 31/05/04<br />

14592 Zafex Zafirlukastum Film-coated tablets 20 mg GENEXO Sp.z.o.o Warszawa 31/12/08<br />

14593 Zafiron Formoterolum Inhalation powder,<br />

capsules<br />

12 µg Adamed Sp. z o.o. 31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1373<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14594 Zalain Sertaconazolum Cream 20 mg/g SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

31/08/04<br />

14595 Zalasta Olanzapinum Tablets 5 mg KRKA Polska Sp. z o.o. 31/12/08<br />

14596 Zalasta Olanzapinum Tablets 10 mg KRKA Polska Sp. z o.o. 31/12/08<br />

14597 Zalbion Tetryzolinum Eye drops, solution 0,5 mg/ml Bioton Sp. z o.o. 31/12/08<br />

14598 Zaldiar Tramadolum +<br />

Paracetamolum<br />

Tablets 37,5 mg +<br />

325 mg<br />

Grünenthal GmbH 31/12/08<br />

14599 Zanidip Lerconidipinum Film-coated tablets 10 mg Recordati S.p.A. 31/12/08<br />

14600 Zanil- zawiesina Oksyklozanid Suspension for veterinary<br />

use<br />

Zakłady Farmaceutyczne<br />

Biowet<br />

10/06/04<br />

14602 Zanocin Ofloxacinum Film-coated tablets 100 mg Ranbaxy Laboratories Ltd. 30/04/04<br />

14603 Zanocin Ofloxacinum Film-coated tablets 200 mg Ranbaxy Laboratories Ltd. 30/04/04<br />

14601 Zanocin Ofloxacinum Solution for<br />

intravenous infusion<br />

14604 Zanocin OD Ofloxacinum Film-coated,<br />

prolonged release<br />

tablets<br />

14605 Zanocin OD Ofloxacinum Film-coated,<br />

prolonged release<br />

tablets<br />

2 mg/ml Ranbaxy Ltd. (Guangzhon<br />

China)<br />

14/02/07<br />

400 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

800 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

14607 Zantac Ranitidinum Effervescent tablets 150 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14608 Zantac Ranitidinum Effervescent tablets 300 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14609 Zantac Ranitidinum Effervescent tablets 75 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14610 Zantac Ranitidinum Film-coated tablets 150 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14611 Zantac Ranitidinum Film-coated tablets 300 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14612 Zantac Ranitidinum Film-coated tablets 75 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14606 Zantac Ranitidinum Solution for injection 25 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14613 Zavedos Idarubicinum Capsules, hard 10 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

14614 Zavedos Idarubicinum Capsules, hard 25 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

14615 Zavedos Idarubicinum Capsules, hard 5 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

14616 Zavedos Idarubicinum Lyophilisate for<br />

solution for injection<br />

14617 Zavedos Idarubicinum Lyophilisate for<br />

solution for injection<br />

14618 Zawiesina Insektobójcza PESS Bioresmetryna Suspension for veterinary<br />

use<br />

10 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

5 mg Pharmacia & Upjohn S.p.A.-<br />

Milano<br />

30/04/05<br />

30/04/05<br />

31/07/04<br />

31/07/04<br />

31/07/04<br />

14/03/07<br />

31/07/04<br />

30/11/04<br />

30/11/04<br />

30/11/04<br />

30/06/04<br />

30/06/04<br />

Wytwórnia Chemiczna PESS 9/11/04<br />

14619 Za˛bkowanie HomeoPorady Laboratoires BOIRON 4/07/07


EN<br />

1374 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14620 Zdrój Mineral medicated<br />

shampoo<br />

Sulphur Zdrój Exim —<br />

Przedsie˛biorstwo<br />

Farmaceutyczne<br />

30/06/05<br />

14621 Zeel comp. Amp. Heel GmbH 31/07/05<br />

14622 Zeel Comp. Ointment Heel GmbH 31/07/05<br />

14623 Zeel comp. Tablets Heel GmbH 31/07/05<br />

14624 Zeel T Amp. Heel GmbH 31/07/05<br />

14625 Zeel T Ointment Heel GmbH 31/07/05<br />

14626 Zeel T Tablets Heel GmbH 31/07/05<br />

14628 Zeffix Lamivudinum Film-coated tablets 100 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14627 Zeffix Lamivudinum Oral solution 5 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

30/04/05<br />

30/04/05<br />

14629 Zeldox Ziprasidonum Capsules 20 mg Pfizer Polska Sp. z o.o. 31/12/08<br />

14630 Zeldox Ziprasidonum Capsules 40 mg Pfizer European Service 31/12/08<br />

14631 Zeldox Ziprasidonum Capsules 80 mg Pfizer European Service 31/12/08<br />

14632 Zeldox Ziprasidonum Capsules 60 mg Pfizer Polska Sp. z o.o. 31/12/08<br />

14633 Zeldox Ziprasidonum Powder for solution<br />

for injection<br />

200 mg/ml Pfizer Healthcare Products 31/12/08<br />

14634 Zelixa Sibutraminum Film-coated tablets 10 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

14635 Zelixa Sibutraminum Film-coated tablets 15 mg P.P.H.U. ‘BIOFARM’ Sp. z o.o. 31/12/08<br />

14636 Zelmac Tegaserodum Tablets 6 mg Novartis Pharma AG 31/12/08<br />

14637 Zenapax Daclizumabum Concentrate for<br />

solution for<br />

intravenous infusion<br />

14638 Zencnil Somatostatinum Powder for solution<br />

for intravenous use<br />

5 mg/ml Hoffmann La Roche Ltd.<br />

Bazylea<br />

30/11/04<br />

3 mg Ferring GmbH 31/12/08<br />

14639 Zˇen-Šen Ginseng Capsules 0.35 g Krka d.d., Novo mesto 30/04/04<br />

14641 Zentel Albendazolum Oral suspension 400mg/20ml SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

14640 Zentel Albendazolum Tablets 200mg SmithKline Beecham<br />

Pharmaceuticals-Brentford<br />

30/04/04<br />

30/04/04<br />

14642 Zenusin 20 Nifedipinum Capsules 20 mg Mepha Ltd. 30/06/04<br />

14643 Zerit Stavudinum Capsules 15 mg Bristol-Myers Squibb 31/12/08<br />

14644 Zerit Stavudinum Capsules 20 mg Bristol-Myers Squibb 31/12/08<br />

14645 Zerit Stavudinum Capsules 30 mg Bristol-Myers Squibb 31/12/08<br />

14646 Zerit Stavudinum Capsules 40 mg Bristol-Myers Squibb 31/12/08<br />

14647 Zerit Stavudinum Powder for oral<br />

suspension<br />

14648 Zestaw do otrzymywania<br />

99mTc-HEDP<br />

Preparat<br />

radiodiagnostyczny<br />

1 mg/ml Bristol-Myers Squibb<br />

Company Champ Lachaud<br />

Lyophilisate 15 mg Samodzielny Publiczny<br />

Zakład Opieki Zdrowotnej<br />

Centralny Szpital Kliniczny<br />

Dział Prod. Radiofarm.<br />

31/12/08<br />

25/01/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1375<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14649 Zestaw do otrzymywania<br />

kompleksu Ù 99m Tc-EC<br />

14650 Zestaw do otrzymywania<br />

kompleksu Ù 99m Tc-ECD<br />

14651 Zestaw do otrzymywania<br />

kompleksu Ù 99mTc-IgG<br />

14652 Zestaw do otrzymywania<br />

radiofarmaceutyku Ù 99m Tc/<br />

Sn/HmPAO<br />

14653 Zestaw do sporza˛dzania<br />

kompleksu 99mTc-MIBI<br />

14654 Zestaw do sporza˛dzania<br />

radiofarmaceutyku 99 m Tc-<br />

DMSA<br />

14655 Zestaw do sporza˛dzania<br />

radiofarmaceutyku 99 m Tc-<br />

DTPA<br />

14656 Zestaw do sporza˛dzania<br />

radiofarmaceutyku 99m Tc-<br />

Tektrotyd<br />

14657 Zestaw do sporza˛dzania<br />

radiofarmaceutyku 99m Tc-<br />

HEPIDA<br />

14658 Zestaw do sporza˛dzania<br />

radiofarmaceutyku 99m Tc-<br />

Koloid<br />

14659 Zestaw do sporza˛dzania<br />

radiofarmaceutyku 99m Tc-<br />

MBrIDA<br />

14660 Zestaw do sporza˛dzania<br />

radiofarmaceutyku 99m Tc-MDP<br />

14661 Zestaw do sporza˛dzania<br />

radiofarmaceutyku 99m Tc-MIBI<br />

14662 Zestaw do sporza˛dzania<br />

radiofarmaceutyku 99m Tc-<br />

Pirofosforan<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

preparat<br />

radiofarmaceutyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Preparat<br />

radiodiagnostyczny<br />

Lyophilisate 5 mg EC Samodzielny Publiczny<br />

Zakład Opieki Zdrowotnej<br />

Centralny Szpital Kliniczny<br />

Dział Prod. Radiofarm.<br />

Lyophilisate 5 mg ECD Samodzielny Publiczny<br />

Zakład Opieki Zdrowotnej<br />

Centralny Szpital Kliniczny<br />

Dział Prod. Radiofarm.<br />

Lyophilisate 5 mg IgG Samodzielny Publiczny<br />

Zakład Opieki Zdrowotnej<br />

Centralny Szpital Kliniczny<br />

Dział Prod. Radiofarm.<br />

Powder for solution<br />

for injection<br />

Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Lyophilisate 1 mg MIBI Samodzielny Publiczny<br />

Zakład Opieki Zdrowotnej<br />

Centralny Szpital Kliniczny<br />

Dział Prod. Radiofarm.<br />

Lyophilisate 1 mg DMSA Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Lyophilisate 10 mg DTPA Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Lyophilisate 20<br />

mikrogramów<br />

HYNIC-Tyr<br />

3-Oktreotyd<br />

Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

POLATOM<br />

Lyophilisate 10 mg HEPIDA Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Lyophilisate Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Lyophilisate 20 mg MBrIDA Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Lyophilisate 5 mg MDP Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Lyophilisate 1 mg MIBI Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

Lyophilisate 8 mg Polatom Os´rodek Badawczo-<br />

Rozwojowy Izotopów<br />

14664 Ziagen Abacavirum Film-coated tablets 300 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14663 Ziagen Abacavirum Oral solution 20 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/03/05<br />

31/12/08<br />

31/12/08<br />

20/09/06<br />

31/03/05<br />

30/04/05<br />

30/04/05<br />

31/12/08<br />

30/01/05<br />

30/01/05<br />

30/01/05<br />

30/04/05<br />

30/01/05<br />

30/04/05<br />

30/06/05<br />

30/06/05<br />

14665 Ziele bratka 2 Phytopharm Dobrzyca 19/11/06<br />

14666 Ziele Bylicy Boz˙ego Drzewka Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

14667 Ziele Bylicy Pospolitej -Herba<br />

Artemisiae<br />

Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

30/10/05<br />

31/12/04


EN<br />

1376 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14668 Ziele drapacza Herba Cnici benedicti Herbapol Lublin 30/11/05<br />

14669 Ziele drapacza lekarskiego Herba Cnici benedicti A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

19/07/07<br />

14670 Ziele drapacza lekarskiego Herba Cnici benedicti Herbalux, Warszawa 19/07/07<br />

14671 Ziele drapacza lekarskiego Herba Cnici benedicti Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14672 Ziele drapacza lekarskiego Herba Cnici benedicti Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14673 Ziele drapacza lekarskiego Herba Cnici benedicti Zioła Lecznicze-Boguccy,<br />

Kraków<br />

14674 Ziele Drapacza lekarskiego -<br />

Herba Cnici benedicti<br />

Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

14675 Ziele dziurawca Hyperici herba A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

19/07/07<br />

19/07/07<br />

19/07/07<br />

31/12/04<br />

24/07/07<br />

14676 Ziele dziurawca Hyperici herba Herbapol Łódz´ 24/07/07<br />

14677 Ziele dziurawca Hyperici herba Varia, Katowice 24/07/07<br />

14678 Ziele dziurawca Hyperici herba Zakład DARY NATURY,<br />

Grodzisk<br />

14679 Ziele dziurawca Hyperici herba Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14680 Ziele dziurawca Hyperici herba Zioła Lecznicze, Boguccy,<br />

Kraków<br />

24/07/07<br />

24/07/07<br />

24/07/07<br />

14681 Ziele dziurawca Hyperici herba Capsules 280 mg Herbalux, Warszawa 9/05/06<br />

14682 Ziele dziurawca (1 i 2) Hyperici herba Herbalux, Warszawa 31/12/08<br />

14683 Ziele dziurawca (1 i 2) Hyperici herba Herbapol Pruszków 31/12/08<br />

14684 Ziele dziurawca<br />

(DEPRESPLANT)<br />

Hyperici herba Capsules 425 mg Aflofarm Fabryka Leków,<br />

Ksawerów<br />

28/02/06<br />

14685 Ziele dziurawca 1 Hyperici herba Elanda, Rozprza 26/11/05<br />

14686 Ziele dziurawca 1 i 2 Hyperici herba Herba Oskar, Wierzbówiec 31/12/08<br />

14687 Ziele dziurawca 1 i 2 Hyperici herba Herbapol Kraków 31/12/08<br />

14688 Ziele dziurawca 1 i 2 Hyperici herba Herbapol Wrocław 31/12/08<br />

14689 Ziele dziurawca 1 i 2 Hyperici herba Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14690 Ziele dziurawca 1 i 2 (Hyper<br />

fix, Dziurawiec fix)<br />

31/12/08<br />

Hyperici herba Herbapol Lublin 2/11/07<br />

14691 Ziele dziurawca 2 Hyperici herba Phytopharm Dobrzyca 19/11/06<br />

14692 Ziele dziurawca 2 Hyperici herba Zakład Konfekcjonowania<br />

Ziół MALWA, Lubiszyn<br />

14693 Ziele dziurawca 2 Hyperici herba Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14694 Ziele Dziurawca fix -Herba<br />

Hyperici<br />

Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

19/11/06<br />

19/11/06<br />

31/12/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1377<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14695 Ziele Dziurawca - Herba<br />

Hyperici<br />

14696 Ziele dziurawca Hypericum<br />

Tea<br />

14697 Ziele dziurawca kaps. 250 mg<br />

HYPERPLANT<br />

Herb Herbapol Pruszków —<br />

Warszawskie Zakłady<br />

Zielarskie<br />

31/12/04<br />

Hyperici herba Elanda, Rozprza 31/10/05<br />

Hyperici herba Phytopharm Kle˛ka S.A. 31/12/08<br />

14698 Ziele fiołka trójbarwnego Violae tricoloris herba A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

19/07/07<br />

14699 Ziele fiołka trójbarwnego Violae tricoloris herba Varia, Katowice 19/07/07<br />

14700 Ziele fiołka trójbarwnego Violae tricoloris herba Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14701 Ziele fiołka trójbarwnego Violae tricoloris herba Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14702 Ziele fiołka trójbarwnego Violae tricoloris herba Zioła Lecznicze, Boguccy,<br />

Kraków<br />

14703 Ziele fiołka trójbarwnego<br />

(Viola fix, Bratek fix)<br />

19/07/07<br />

19/07/07<br />

19/07/07<br />

Violae tricoloris herba Herbapol Lublin 24/09/07<br />

14704 Ziele fiołka trójbarwnego 1 i 2 Violae tricoloris herba Herbalux, Warszawa 30/04/05<br />

14705 Ziele fiołka trójbarwnego 1 i 2 Violae tricoloris herba Herbapol Pruszków 30/04/05<br />

14706 Ziele fiołka trójbarwnego 1 i 2 Violae tricoloris herba Herbapol Wrocław 30/04/05<br />

14707 Ziele fiołka trójbarwnego 1 i 2 Violae tricoloris herba Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14708 Ziele fiołka trójbarwnego 1 i 2<br />

-Zioła w tor. do zaparzania<br />

14709 Ziele fiołka trójbarwnego Viola<br />

Tea<br />

30/04/05<br />

Violae tricoloris herba Herbapol Kraków 31/08/05<br />

Violae tricoloris herba Elanda, Rozprza 31/10/05<br />

14710 Ziele glistnika Herbaflos, Płońsk 31/12/07<br />

14711 Ziele glistnika Herbalux, Warszawa 31/12/07<br />

14712 Ziele glistnika Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14713 Ziele glistnika Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14714 Ziele glistnika Zioła Lecznicze-Boguccy,<br />

Kraków<br />

14715 Ziele Glistnika -Herba<br />

Chelidoni<br />

Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

31/12/07<br />

31/12/07<br />

31/12/07<br />

31/12/04<br />

14716 Ziele jasnoty białej Herb Herbapol, Gdańsk 31/12/08<br />

14717 Ziele karczocha Cynarae herba Herb Zakład Konfekcjonowania<br />

Ziół FLOS, Mokrsko<br />

14718 Ziele krwawnika Millefolii herba Herb in bags Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

14719 Ziele krwawnika Millefolii herba A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

31/12/08<br />

30/08/07<br />

30/08/07


EN<br />

1378 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14720 Ziele krwawnika Millefolii herba Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

30/08/07<br />

14721 Ziele krwawnika 1 Millefolii herba Elanda, Rozprza 31/08/05<br />

14722 Ziele krwawnika 1 Millefolii herba Herbapol Kraków 31/08/05<br />

14723 Ziele krwawnika 1 Millefolii herba Zioła Lecznicze Boguccy,<br />

Kraków<br />

31/08/05<br />

14724 Ziele krwawnika 1 i 2 Millefolii herba Herbalux, Warszawa 30/09/05<br />

14725 Ziele krwawnika 1 i 2 Millefolii herba Herbapol Pruszków 30/09/05<br />

14726 Ziele krwawnika 1 i 2 Millefolii herba Herbapol Wrocław 30/09/05<br />

14727 Ziele krwawnika 1 i 2 Millefolii herba Varia, Katowice 30/09/05<br />

14728 Ziele krwawnika 1 i 2 Millefolii herba Zakład DARY NATURY,<br />

Grodzisk<br />

14729 Ziele krwawnika 1 i 2 Millefolii herba Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14730 Ziele krwawnika 1 i 2<br />

(Achillea fix, Krwawnik fix)<br />

30/09/05<br />

30/09/05<br />

Millefolii herba Herbapol Lublin 31/12/07<br />

14731 Ziele krwawnika 2 Millefolii herba Phytopharm Dobrzyca 19/11/06<br />

14732 Ziele krwawnika 2 Millefolii herba Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14733 Ziele lebiodki Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14734 Ziele lebiodki Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14735 Ziele lebiodki Zioła Lecznicze-Boguccy,<br />

Kraków<br />

19/11/06<br />

18/12/05<br />

18/12/05<br />

18/12/05<br />

14736 Ziele lebiodki 1 Herbapol Kraków 31/08/05<br />

14737 Ziele macierzanki Herbapol Lublin 31/12/07<br />

14738 Ziele macierzanki Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14739 Ziele macierzanki Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/12/07<br />

31/12/07<br />

14740 Ziele macierzanki 1 Herbapol Kraków 31/08/05<br />

14741 Ziele macierzanki 1 Zioła Lecznicze Boguccy,<br />

Kraków<br />

31/08/05<br />

14742 Ziele macierzanki 1 i 2 Herbalux, Warszawa 10/04/06<br />

14743 Ziele majeranku Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

31/12/08<br />

14744 Ziele nawłoci Herb Bogucki, Kraków 30/10/05<br />

14745 Ziele Nawłoci Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/10/05<br />

14746 Ziele Nawłoci Herb Herbapol Lublin S.A. 30/10/05<br />

14747 Ziele Nawłoci Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

30/10/05<br />

14748 Ziele nawłoci pospolitej Herb Herbalux, Warszawa 31/12/08<br />

14749 Ziele nostrzyka Herba meliloti A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

19/07/07<br />

14750 Ziele nostrzyka Herba meliloti Herbalux, Warszawa 19/07/07<br />

14751 Ziele nostrzyka Herba meliloti Herbapol Lublin 19/07/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1379<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14752 Ziele nostrzyka Herba meliloti Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14753 Ziele nostrzyka Herba meliloti Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14754 Ziele nostrzyka Herba meliloti Zioła Lecznicze Boguccy,<br />

Kraków<br />

14755 Ziele Nostrzyka -Herba Meliloti Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

14756 Ziele ogórecznika Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

14757 Ziele Pie˛ciornika ge˛siego Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

14758 Ziele piołunu Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14759 Ziele piołunu (Absinthium fix,<br />

Piołun fix)<br />

19/07/07<br />

19/07/07<br />

19/07/07<br />

31/12/04<br />

31/12/08<br />

30/10/05<br />

31/12/08<br />

Herbapol Lublin 31/12/08<br />

14760 Ziele piołunu 1 Herbalux, Warszawa 25/08/06<br />

14761 Ziele piołunu 1 i 2 Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14762 Ziele piołunu 1 i 2 Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/12/08<br />

31/12/08<br />

14763 Ziele piołunu 2 Phytopharm Dobrzyca 19/12/06<br />

14764 Ziele podróz˙nika Herb Kawon, Gostyń 30/06/06<br />

14765 Ziele podróz˙nika Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/06/06<br />

14766 Ziele pokrzywy Herb Herbapol, Gdańsk 30/10/05<br />

14767 Ziele pokrzywy Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

14768 Ziele Pokrzywy Herb Herba Lux s.c. Zakład<br />

Przetwórstwa Zielarskiego<br />

14769 Ziele Pokrzywy Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

14770 Ziele Pokrzywy Herb Herba Lux s.c. Zakład<br />

Przetwórstwa Zielarskiego<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

14771 Ziele pokrzywy fix Herb Herbapol, Gdańsk 31/12/08<br />

14772 Ziele połonicznika Herbalux, Warszawa 26/03/06<br />

14773 Ziele połonicznika Herbapol Lublin 26/03/06<br />

14774 Ziele połonicznika Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14775 Ziele połonicznika Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14776 Ziele Połonicznika Herba<br />

Herniariae<br />

Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

26/03/06<br />

26/03/06<br />

31/12/04<br />

14777 Ziele poziewnika Herb Bogucki, Kraków 31/12/08


EN<br />

1380 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14778 Ziele poziewnika Herb Zioła Lecznicze 31/12/08<br />

14779 Ziele przetacznika Herb Kawon, Gostyń 31/12/08<br />

14780 Ziele przywrotnika Herb HERBAPOL BIAŁYSTOK S.A. 30/06/06<br />

14781 Ziele przywrotnika Herb Kawon, Gostyń 30/06/06<br />

14782 Ziele Przywrotnika Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/06/06<br />

14783 Ziele rdestu ostrogorzkiego Herbalux, Warszawa 31/12/08<br />

14784 Ziele rdestu ostrogorzkiego Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/12/08<br />

14785 Ziele rdestu ostrogorzkiego 1 Herbapol Kraków 31/08/05<br />

14786 Ziele rdestu ostrogorzkiego 1 Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

31/08/05<br />

14787 Ziele rdestu ptasiego Herbapol Pruszków 15/03/05<br />

14788 Ziele rdestu ptasiego Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14789 Ziele rdestu ptasiego Zioła Lecznicze Boguccy,<br />

Kraków<br />

15/03/05<br />

15/03/05<br />

14790 Ziele rdestu ptasiego (1 i 2) Herbalux, Warszawa 31/12/08<br />

14791 Ziele rdestu ptasiego 1 Herbapol Kraków 31/08/05<br />

14792 Ziele rdestu ptasiego 1 i 2 Herbapol Pruszków 30/09/05<br />

14793 Ziele rdestu ptasiego 1 i 2 Herbapol Wrocław 30/09/05<br />

14794 Ziele rdestu ptasiego 1 i 2 Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14795 Ziele rdestu ptasiego 1 i 2<br />

(Polygonum fix, Rdest fix)<br />

30/09/05<br />

Herbapol Lublin 31/12/07<br />

14796 Ziele rdestu ptasiego 2 Phytopharm Dobrzyca 9/04/06<br />

14797 Ziele rzepiku Herb Kawon, Gostyń 30/06/06<br />

14798 Ziele rzepiku Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

14799 Ziele Serdecznika Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/06/06<br />

30/10/05<br />

14800 Ziele Serdecznika Herb Herbapol Lublin S.A. 30/10/05<br />

14801 Ziele Serdecznika Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

14802 Ziele Serdecznika -Herba<br />

Leonuri<br />

Leonuri cardiaceae herba Herb Herbapol Kraków S.A. —<br />

Krakowskie Zakłady<br />

Zielarskie<br />

14803 Ziele skrzypu Herba equiseti Herb A-Z MEDICA Sp. z o.o.,<br />

Sopot<br />

14804 Ziele skrzypu Herba equiseti Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

30/10/05<br />

31/12/06<br />

19/07/07<br />

19/07/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1381<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14805 Ziele skrzypu Herba equiseti Zioła Lecznicze Boguccy,<br />

Kraków<br />

19/07/07<br />

14806 Ziele skrzypu (1 i 2) Herba equiseti Herba Oskar, Wierzbówiec 31/12/08<br />

14807 Ziele skrzypu (1 i 2) Herba equiseti Herbalux, Warszawa 31/12/08<br />

14808 Ziele skrzypu (2) Herba equiseti Elanda, Rozprza 30/04/06<br />

14809 Ziele skrzypu 1 i 2 Herba equiseti Herbapol Kraków 30/11/05<br />

14810 Ziele skrzypu 1 i 2 Herba equiseti Herbapol Wrocław 30/11/05<br />

14811 Ziele skrzypu 1 i 2 Herba equiseti Varia, Katowice 30/11/05<br />

14812 Ziele skrzypu 1 i 2 Herba equiseti Zakład DARY NATURY,<br />

Grodzisk<br />

14813 Ziele skrzypu 1 i 2 Herba equiseti Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14814 Ziele skrzypu 1 i 2 (Equisetum<br />

fix, Skrzyp fix)<br />

30/11/05<br />

30/11/05<br />

Herba equiseti Herbapol Lublin 2/11/07<br />

14815 Ziele skrzypu 2 Herba equiseti Phytopharm Dobrzyca 19/11/06<br />

14816 Ziele skrzypu 2 Herba equiseti Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

19/11/06<br />

14817 Ziele skrzypu polnego 1 i 2 Herba equiseti Herbapol Pruszków 30/11/05<br />

14818 Ziele srebrnika Herb Kawon, Gostyń 30/10/05<br />

14819 Ziele Srebrnika Herb Herbapol Lublin S.A. 30/10/05<br />

14820 Ziele szanty Herb Bogucki, Kraków 30/10/05<br />

14821 Ziele Szanty Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

30/10/05<br />

14822 Ziele szanty Herb HERBAPOL BIAŁYSTOK S.A. 31/12/08<br />

14823 ziele s´wietlika Euphrasiae herba Herb Elanda S.C. 30/10/05<br />

14826 Ziele S´ wietlika Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

14827 Ziele S´ wietlika Herb Herba Lux s.c. Zakład<br />

Przetwórstwa Zielarskiego<br />

14828 Ziele S´ wietlika Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

14829 Ziele S´ wietlika Herb Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

14830 Ziele S´ wietlika Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

14831 Ziele S´ wietlika Herb Zioła Lecznicze — Boguccy<br />

s.c.<br />

14832 Ziele S´ wietlika Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

14833 Ziele S´ wietlika Herb Herba Lux s.c. Zakład<br />

Przetwórstwa Zielarskiego<br />

14834 Ziele S´ wietlika Herb Phytopharm Dobrzyca Sp.<br />

z o.o.<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/10/05<br />

30/06/06<br />

30/06/05<br />

30/10/05<br />

30/10/05<br />

30/10/05


EN<br />

1382 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14835 Ziele S´ wietlika Herb Herbaflos Zakład<br />

Przetwórstwa Zielarskiego<br />

31/08/05<br />

14824 Ziele S´ wietlika Herb Herbapol Lublin S.A. 30/10/05<br />

14825 Ziele S´ wietlika Herb in bags Herbapol Lublin S.A. 30/10/05<br />

14836 Ziele tasznika Herb Bogucki, Kraków 30/10/05<br />

14837 Ziele tasznika Herb Herbapol, Gdańsk 30/10/05<br />

14838 Ziele tasznika Herb Kawon, Gostyń 30/10/05<br />

14839 Ziele Tasznika Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

30/10/05<br />

14840 Ziele Tasznika Herb Herbapol Lublin S.A. 30/10/05<br />

14841 Ziele tasznika fix Herb Herbapol, Gdańsk 31/12/08<br />

14842 Ziele tymianku Herbapol Białystok 13/05/06<br />

14843 Ziele tymianku Herbapol Kraków 13/05/06<br />

14844 Ziele tymianku Herbapol Pruszków 13/05/06<br />

14845 Ziele tymianku Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14846 Ziele tymianku Capsules 350 mg Aflofarm Fabryka Leków,<br />

Ksawerów<br />

13/05/06<br />

9/10/05<br />

14847 Ziele tymianku (1 i 2) Herbalux, Warszawa 31/12/08<br />

14848 Ziele tymianku 1 Zioła Lecznicze Boguccy,<br />

Kraków<br />

14849 Ziele tymianku 1 i 2 Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14850 Ziele tymianku kaps. 250 mg<br />

Tussiplant<br />

15/02/05<br />

31/12/08<br />

Phytopharm Kle˛ka S.A. 31/12/08<br />

14851 Ziele tysia˛cznika Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/03/05<br />

14852 Ziele tysie˛cznika Herbapol Lublin 31/12/07<br />

14853 Ziele tysie˛cznika Zioła Lecznicze Boguccy,<br />

Kraków<br />

31/12/07<br />

14854 Ziele tysie˛cznika 1 Herbalux, Warszawa 10/04/06<br />

14855 Ziele tysie˛cznika 1 Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14856 Ziele wierzbówki kiprzycy Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

14857 Ziele wierzbówki kiprzycy fix Herb Krakowskie Zakłady<br />

Zielarskie ‘HERBAPOL’ S.A.<br />

14858 Zifam 10 Simvastatinum Film-coated tablets 10 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14859 Zifam 20 Simvastatinum Film-coated tablets 20 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

14860 Zifam 40 Simvastatinum Film-coated tablets 40 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

10/04/06<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1383<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14861 Zifam 80 Simvastatinum Film-coated tablets 80 mg Warszawskie Zakłady<br />

Farmaceutyczne POLFA<br />

31/12/08<br />

14862 Zilden Diltiazemum Tablets 60 mg Alfa Wassermann S.p.A. 30/06/04<br />

14866 Zinacef Cefuroximum Powder for solution<br />

for intravascular<br />

injection and infusion<br />

14863 Zinacef Cefuroximum Powder for<br />

suspension for<br />

intramuscular<br />

injection and for<br />

solution for<br />

intravenous injection<br />

14864 Zinacef Cefuroximum Powder for<br />

suspension for<br />

intramuscular<br />

injection and for<br />

solution for<br />

intravenous injection<br />

14865 Zinacef Cefuroximum Powder for<br />

suspension for<br />

intramuscular<br />

injection and for<br />

solution for<br />

intravenous injection<br />

1.5 g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

250 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

750 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

250 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

30/10/05<br />

14867 Zinaxin Capsules, soft 255 mg Eurovita International A/S 31/10/04<br />

14868 Zincas Zinci hydroaspartas Tablets 5.5 mg Zn++ Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

14869 Zincas forte Zinci hydroaspartas Tablets 27 mg Zn++ Farmapol Sp. z o.o. Zakład<br />

Chemiczno-Farmaceutyczny<br />

14870 Zincteral Zinci sulfas Film-coated tablets 45 mg Zn++ Kutnowskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

31/01/06<br />

31/01/06<br />

31/12/05<br />

14871 Zincuprin Tablets Sun-Farm Sp.z o.o. Kołbiel 31/03/07<br />

14872 Zincuprin Forte Tablets Sun-Farm Sp.z o.o. Kołbiel 31/03/07<br />

14873 Zindaclin Clindamycinum Gel 1 % Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

14874 Zineryt Erythromycinum Powder and solvent<br />

for solution for<br />

external use<br />

14875 Zingibir Zingiberis rhizomae<br />

pulv.<br />

31/12/08<br />

40 mg/ml Yamanouchi Europe B.V. 31/03/04<br />

Tablets 500 mg Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

14881 Zinnat Cefuroximum Film-coated tablets 125 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14882 Zinnat Cefuroximum Film-coated tablets 250 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14883 Zinnat Cefuroximum Film-coated tablets 500 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14876 Zinnat Cefuroximum Granules for oral<br />

suspension<br />

14877 Zinnat Cefuroximum Granules for oral<br />

suspension<br />

125 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

125 mg/5 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/12/08<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

30/04/04


EN<br />

1384 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14878 Zinnat Cefuroximum Granules for oral<br />

suspension<br />

14879 Zinnat Cefuroximum Granules for oral<br />

suspension<br />

14880 Zinnat Cefuroximum Granules for oral<br />

suspension<br />

250 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

250 mg/5 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

250 mg/5 ml GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

30/11/04<br />

31/01/05<br />

31/03/05<br />

14884 Zioła z˙ółciope˛dne Elanda, Rozprza 19/07/07<br />

14885 Zioła do plukania gardła Species ad gargarisma Herbapol Kraków 31/12/07<br />

14886 Zioła do płukania gardła Species ad gargarisma Bags 2.1 g Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

4/05/07<br />

14887 Zioła do płukania gardła Species ad gargarisma Herbalux, Warszawa 4/05/07<br />

14888 Zioła do płukania gardła 1 i 2 Species ad gargarisma Elanda, Rozprza 29/08/07<br />

14889 Zioła do zmniejszania nadwagi Species reducentes Bags 2.0 g Zakład Konfekcjonowania<br />

Ziół MALWA, Lubiszyn<br />

14890 Zioła do zmniejszania nadwagi Species reducentes Herb in bags Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14891 Zioła do zmniejszania nadwagi Species reducentes Herb in bags Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14/05/07<br />

14/05/07<br />

14/05/07<br />

14892 Zioła do zmniejszania nadwagi Species reducentes Herbalux, Warszawa 14/05/07<br />

14893 Zioła do zmniejszania nadwagi Species reducentes Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

14/05/07<br />

14894 Zioła do zmniejszania nadwagi Species reducentes Varia, Katowice 14/05/07<br />

14895 Zioła do zmniejszania nadwagi<br />

(1 i 2)<br />

Species reducentes Herbapol Pruszków 31/07/05<br />

14896 Zioła metaboliczne Species metabolicae Bags 2.0 g Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

14/05/07<br />

14897 Zioła metaboliczne (1 i 2) Species metabolicae Herbapol Pruszków 30/04/06<br />

14898 Zioła metaboliczne 1 i 2 Species metabolicae Elanda, Rozprza 31/12/07<br />

14899 Zioła metaboliczne 1 i 2 Species metabolicae Herbalux, Warszawa 31/12/07<br />

14900 Zioła metaboliczne 1 i 2 Species metabolicae Izis, Warszawa 31/12/07<br />

14901 Zioła metaboliczne 1 i 2<br />

(METABOLSON)<br />

Species metabolicae Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14902 Zioła moczope˛dne Species diureticae Herb Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

4/07/06<br />

27/09/07<br />

14903 Zioła moczope˛dne Species diureticae Herbapol Kraków 27/09/07<br />

14904 Zioła moczope˛dne Species diureticae Herbapol Pruszków 27/09/07<br />

14905 Zioła moczope˛dne Species diureticae Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

27/09/07<br />

14906 Zioła moczope˛dne Species diureticae Varia, Katowice 27/09/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1385<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14907 Zioła moczope˛dne 1 i 2 Species diureticae Elanda, Rozprza 14/08/07<br />

14908 Zioła moczope˛dne 1 i 2 Species diureticae Herbalux, Warszawa 14/08/07<br />

14909 Zioła moczope˛dne 1 i 2 Species diureticae Izis, Warszawa 14/08/07<br />

14910 Zioła moczope˛dne 1 i 2<br />

Urolson<br />

Species diureticae Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14911 Zioła poprawiaja˛ce trawienie Species digestivae Bags 2.3 g Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

31/01/05<br />

24/05/07<br />

14912 Zioła poprawiaja˛ce trawienie Species digestivae Bonimed, Z˙ywiec 24/05/07<br />

14913 Zioła poprawiaja˛ce trawienie Species digestivae Herbalux, Warszawa 24/05/07<br />

14914 Zioła poprawiaja˛ce trawienie<br />

(1 i 2)<br />

14915 Zioła poprawiaja˛ce trawienie<br />

1i2<br />

14916 Zioła poprawiaja˛ce trawienie 2<br />

Fito Mix VII Fix<br />

Species digestivae Herbapol Kraków 31/12/08<br />

Species digestivae Izis, Warszawa 31/01/06<br />

Species digestivae Herbapol Pruszków 10/02/06<br />

14917 Zioła przecikaszlowe Herbapol Kraków 31/12/07<br />

14918 Zioła przeciw cukrzycy Preparat złoz˙ony Instant herbal tea Zakład Konfekcjonowania<br />

Ziół ‘Malwa’, Lubiszyn<br />

14919 Zioła przeciwbiegunkowe Species antidiarrhoicae Bags 2.5 g Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

31/12/08<br />

19/03/07<br />

14920 Zioła przeciwbiegunkowe Species antidiarrhoicae Herbapol Kraków 19/03/07<br />

14921 Zioła przeciwbiegunkowe Species antidiarrhoicae Herbapol Pruszków 19/03/07<br />

14922 Zioła przeciwgora˛czkowe Species Antipyreticae Bags 2.3 g Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

24/05/07<br />

14923 Zioła przeciwgora˛czkowe Species antypyreticae Elanda, Rozprza 24/05/07<br />

14924 Zioła przeciwgora˛czkowe Species antypyreticae Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

24/05/07<br />

14925 Zioła przeciwgora˛czkowe 1 Species antypyreticae Bonimed, Z˙ywiec 9/11/05<br />

14926 Zioła przeciwgora˛czkowe 1 i 2 Species antypyreticae Herbalux, Warszawa 24/06/07<br />

14927 Zioła przeciwgora˛czkowe 1 i 2<br />

Gryposon<br />

Species antypyreticae Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

31/01/05<br />

14928 Zioła przeciwgora˛czkowe 2 Species antypyreticae Herbapol Pruszków 28/02/06<br />

14929 Zioła przeciwgrzybiczne Preparat złoz˙ony Instant herbal tea Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

14930 Zioła przeciwkaszlowe Species antibechicae Bags 2.0 g Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczneg<br />

LABOFARM mgr farm.<br />

Tadeusz Pawełek<br />

31/12/08<br />

14/05/07


EN<br />

1386 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14931 Zioła przeciwkaszlowe Species antybechicae Herb in bags Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

14932 Zioła przeciwreumatyczne Species<br />

antirheumaticae<br />

14933 Zioła przeciwreumatyczne Species<br />

antirheumaticae<br />

14934 Zioła przeciwreumatyczne Species<br />

antirheumaticae<br />

14935 Zioła przeciwreumatyczne 1 Species<br />

antirheumaticae<br />

14936 Zioła przeciwreumatyczne 1 i 2 Species<br />

antirheumaticae<br />

14937 Zioła przeciwreumatyczne 1 i 2 Species<br />

antirheumaticae<br />

Bags 2.3 g Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

Herb Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14/05/07<br />

24/05/07<br />

24/05/07<br />

Herbapol Pruszków 24/05/07<br />

Bonimed, Z˙ywiec 9/11/05<br />

Herbalux, Warszawa 24/06/07<br />

Herbapol Kraków 24/06/07<br />

14938 Zioła przeczyszczaja˛ce Species laxantes Bags 2.0 g PPH Biofluid 19/04/07<br />

14939 Zioła przeczyszczaja˛ce Species laxantes Herb Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

19/04/07<br />

14940 Zioła przeczyszczaja˛ce Species laxantes Herbalux, Warszawa 19/04/07<br />

14941 Zioła przeczyszczaja˛ce Species laxantes Herbapol Kraków 19/04/07<br />

14942 Zioła przeczyszczaja˛ce Species laxantes Herbapol Pruszków 19/04/07<br />

14943 Zioła przeczyszczaja˛ce Species laxantes Zioła Lecznicze-Boguccy,<br />

Kraków<br />

19/04/07<br />

14944 Zioła przeczyszczaja˛ce 1 i 2 Species laxantes Elanda, Rozprza 29/08/07<br />

14945 Zioła przeczyszczaja˛ce 1 i 2<br />

REGULSON<br />

Species laxantes Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14946 Zioła tonizuja˛ce Preparat złoz˙ony Instant herbal tea Innowacyjno Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM,<br />

Starogard Gdański<br />

14947 Zioła ułatwiaja˛ce gojenie ran Species advulnantes Herb in bags Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

19/07/05<br />

31/12/08<br />

14/05/07<br />

14948 Zioła ułatwiaja˛ce gojenie ran Species advulnantes Herbapol Kraków 14/05/07<br />

14949 Zioła ułatwiaja˛ce gojenie ran<br />

1i2<br />

Species advulnantes Herbalux, Warszawa 4/08/07<br />

14950 Zioła uławiaja˛ce gojenie ran Species advulnantes Bags 2.0 g Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

14951 Zioła uspakajaja˛ce Species sedativae Herb Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14/05/07<br />

24/07/07<br />

14952 Zioła uspakajaja˛ce Species sedativae Herbalux, Warszawa 24/07/07


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1387<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14953 Zioła uspakajaja˛ce Species sedativae Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

24/07/07<br />

14954 Zioła uspakajaja˛ce Species sedativae Varia, Katowice 24/07/07<br />

14955 Zioła uspakajaja˛ce Species sedativae Zakład Konfekcjonowania<br />

Ziół MALWA, Lubiszyn<br />

14956 Zioła uspakajaja˛ce Species sedativae Zioła Lecznicze-Boguccy,<br />

Kraków<br />

24/07/07<br />

24/07/07<br />

14957 Zioła uspakajaja˛ce (1 i 2) Species sedativae Herbapol Kraków 31/12/07<br />

14958 Zioła uspakajaja˛ce (1 i 2) Species sedativae Herbapol Pruszków 31/12/07<br />

14959 Zioła uspakajaja˛ce 1 Species sedativae Bonimed, Z˙ywiec 14/11/05<br />

14960 Zioła uspakajaja˛ce 1 i 2 Species sedativae Izis, Warszawa 31/01/06<br />

14961 Zioła uspakajaja˛ce 1 i 2<br />

(RELAKSON)<br />

Species sedativae Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

5/09/05<br />

14962 Zioła uspokajaja˛ce 1 i 2 Species sedativae Elanda, Rozprza 29/08/07<br />

14963 Zioła wykrztus´ne Elanda, Rozprza 4/08/07<br />

14964 Zioła wykrztus´ne Herbalux, Warszawa 4/08/07<br />

14965 Zioła wykrztus´ne Herbapol Kraków 4/08/07<br />

14966 Zioła wykrztus´ne Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

4/08/07<br />

14967 Zioła wykrztus´ne (2) Herbapol Pruszków 31/12/05<br />

14968 Zioła wzmagaja˛ce trawienie Species Stomachicae Bags 2.0 g Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

24/05/07<br />

14969 Zioła wzmagaja˛ce trawienie Species Stomachicae Herbapol Kraków 24/05/07<br />

14970 Zioła wzmagaja˛ce trawienie 1 i 2 Species Stomachicae Herbalux, Warszawa 14/08/07<br />

14971 Zioła wzmagaja˛ce trawienie<br />

1 i 2 KALORSON<br />

Species Stomachicae Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14973 Zioła z˙ółciope˛dne Species cholagogae Herb Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

14972 Zioła z˙ółciope˛dne Species cholagogae Herb in bags Zakład Konfekcjonowania<br />

Ziół Flos, Mokrsko<br />

30/11/06<br />

24/07/06<br />

24/07/06<br />

14974 Zioła z˙ółciope˛dne Species cholagogae Herbalux, Warszawa 24/07/06<br />

14975 Zioła z˙ółciope˛dne Species cholagogae Herbapol Kraków 24/07/06<br />

14976 Zioła z˙ółciope˛dne Species cholagogae Innowacyjno-Wdroz˙eniowe<br />

Laboratorium<br />

Farmaceutyczne LABOFARM<br />

mgr farm. Tadeusz Pawełek<br />

24/07/06<br />

14977 Zioła z˙ółciope˛dne Species cholagogae Varia, Katowice 24/07/06<br />

14978 Zioła z˙ółciope˛dne 1 i 2 Species cholagogae Izis, Warszawa 31/01/06


EN<br />

1388 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

14979 Zioła z˙ółciope˛dne 1 i 2<br />

(HEPAROSON)<br />

Species cholagogae Zakład Zielarski Kawon-Hurt<br />

Nowak Sp. J.<br />

14980 Znamie˛ Kukurydzy Herb Flos Zakład<br />

Konfekcjonowania Ziół —<br />

Elz˙bieta i Jan Goła˛b<br />

14981 Znamie˛ Kukurydzy Herb Kawon — Hurt s.c. — Zakład<br />

Zielarski<br />

4/07/06<br />

30/10/05<br />

30/10/05<br />

14982 Znamiona kukurydzy Herb HERBAPOL BIAŁYSTOK S.A. 31/12/08<br />

14983 Zocor 10 Simvastatinum Film-coated tablets 10 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

14984 Zocor 20 Simvastatinum Film-coated tablets 20 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

14985 Zocor 40 Simvastatinum Film-coated tablets 40 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

14986 Zocor 80 Simvastatinum Film-coated tablets 80 mg Merck Sharp & Dohme Idea<br />

Inc.<br />

20/07/05<br />

20/07/05<br />

31/12/08<br />

12/10/05<br />

14987 Zodac Cetirizinum Film-coated tablets 10 mg Lečiva a.s. 20/06/07<br />

14988 Zofenil 30 Zofenoprylum Film-coated tablets 30 mg BERLIN — CHEMIE AG<br />

(Menarini Group)<br />

14989 Zofenil 7,5 Zofenoprylum Film-coated tablets 7,5 mg BERLIN — CHEMIE AG<br />

(Menarini Group)<br />

14995 Zofran Ondansetronum Film-coated tablets 4 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14996 Zofran Ondansetronum Film-coated tablets 4 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

14997 Zofran Ondansetronum Film-coated tablets 8 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14998 Zofran Ondansetronum Film-coated tablets 8 mg GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

14993 Zofran Ondansetronum Solution for<br />

intravenous and<br />

intramuscular<br />

injection<br />

14991 Zofran Ondansetronum Solution for<br />

intravenous injection<br />

14992 Zofran Ondansetronum Solution for<br />

intravenous injection<br />

2 mg/1 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

4 mg/2 ml GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

8 mg/4 ml GlaxoSmithKline<br />

Pharmaceuticals S.A.<br />

14990 Zofran Ondansetronum Suppository 16 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14994 Zofran Ondansetronum Syrup 4 mg/5ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

14999 Zofran Zydis Ondansetronum Oral lyophilisate 4 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

15000 Zofran Zydis Ondansetronum Oral lyophilisate 8 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/07<br />

31/12/07<br />

31/12/08<br />

31/12/08<br />

26/04/06<br />

26/04/06<br />

15001 Zoladex Goserelinum Subcutaneous implant 3.6 mg AstraZeneca UK Ltd. 30/04/04<br />

15002 Zoladex LA Goserelinum Subcutaneous implant 10.8 mg AstraZeneca UK Ltd. 31/12/08<br />

15003 Zolafren Olanzapinum Capsules 5 mg Adamed Sp. z o.o. 25/10/06


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1389<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

15004 Zolafren Olanzapinum Capsules 7,5 mg Adamed Sp. z o.o. 31/12/08<br />

15005 Zolafren Olanzapinum Capsules 10 mg Adamed Sp. z o.o. 25/10/06<br />

15006 Zolafren Olanzapinum Film-coated tablets 10 mg Adamed Sp. z o.o. 25/10/06<br />

15007 Zolafren Olanzapinum Film-coated tablets 5 mg Adamed Sp. z o.o. 25/10/06<br />

15008 Zoleptil 100 Zotepinum Film-coated tablets 100 mg Pharma Avalanche 31/12/08<br />

15009 Zoleptil 25 Zotepinum Film-coated tablets 25 mg Pharma Avalanche 31/12/08<br />

15010 Zoleptil 50 Zotepinum Film-coated tablets 50 mg Pharma Avalanche 31/12/08<br />

15011 Zoloft Sertralinum Concentrate for oral<br />

solution<br />

20 mg/ml Pfizer European Service<br />

Center N.V./S.A.; Central and<br />

Eastern Europe Region<br />

14/02/07<br />

15012 Zoloft Sertralinum Film-coated tablets 100 mg Pfizer Bruksela 31/12/08<br />

15013 Zoloft Sertralinum Film-coated tablets 50 mg Pfizer Bruksela 31/12/08<br />

15014 Zolpic Zolpidemum Film-coated tablets 5 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

15015 Zolpic Zolpidemum Film-coated tablets 10 mg Zakłady Farmaceutyczne<br />

‘POLPHARMA’ S.A.<br />

31/12/08<br />

31/12/08<br />

15016 Zolpid Zolpidemum Film-coated tablets 10 mg HEXAL AG 31/12/08<br />

15017 Zolpiden Zolpidemum Film-coated tablets 10 mg Tarchomińskie Zakłady<br />

Farmaceutyczne POLFA S.A.<br />

15018 Zolpix Zolpidemum Film-coated tablets 10 mg Zakład Produkcji Chemiczno<br />

— Farmaceutycznej<br />

s.c.‘CHANCE’, Łomianki<br />

15019 Zomacton 4 Somatropinum Lyophilisate for<br />

injection<br />

15020 Zomacton 12 Somatropinum Lyophilisate for<br />

injection<br />

15021 Zometa Acidum zoledronicum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

15022 Zomifos Acidum zoledronicum Powder and solvent<br />

for solution for<br />

intravenous infusion<br />

1.62 mg<br />

(4,86 j.m.)<br />

4.32 mg<br />

(12,96 j.m.)<br />

31/12/08<br />

31/12/08<br />

Ferring GmbH 31/12/08<br />

Ferring GmbH 31/12/08<br />

4 mg Novartis Pharma AG 24/05/06<br />

4 mg VIPHARM S.A. Warszawa 31/12/08<br />

15023 Zomig Zolmitriptanum Film-coated tablets 2.5 mg AstraZeneca UK Ltd. 30/09/04<br />

15024 Zomig Zolmitriptanum Film-coated tablets 5 mg AstraZeneca UK Ltd. 30/09/04<br />

15025 Zomiren Alprazolamum Tablets 0.25 mg Krka d.d., Novo mesto 12/10/05<br />

15026 Zomiren Alprazolamum Tablets 0.5 mg Krka d.d., Novo mesto 12/10/05<br />

15027 Zomiren Alprazolamum Tablets 1 mg Krka d.d., Novo mesto 12/10/05<br />

15028 Zonadin Zolpidemum Film-coated tablets 10 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

15029 Zonadin Zolpidemum Film-coated tablets 5 mg PLIVA Kraków Zakłady<br />

Farmaceutyczne S.A.<br />

31/12/08<br />

31/12/08<br />

15030 Zopiclon 7,5-SL Zopiclonum Film-coated tablets 7.5 mg Slovakofarma a.s. Hlodovec 25/04/07<br />

15031 Zopiclone Zopiclonum Film-coated tablet 7,5 mg Przedsie˛biorstwo<br />

Farmaceutyczne JELFA S.A<br />

31/12/08


EN<br />

1390 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

15032 Zopiratio Zopiclonum Film-coated tablets 7.5 mg ratiopharm GmbH 21/06/06<br />

15033 Zopix Zolpidemum Film-coated tablets 7,5 mg Expharm Inc. 31/12/08<br />

15034 Zopix Zolpidemum Film-coated tablets 10 mg Expharm Inc. 31/12/08<br />

15035 Zorac Tazarotenum Gel 0.5 mg/g Pierre Fabre Dermatologie 15/11/06<br />

15036 Zorac Tazarotenum Gel 1 mg/g Pierre Fabre Dermatologie 15/11/06<br />

15037 Zostex Brivudinum Tablets 125 mg BERLIN — CHEMIE AG<br />

(Menarini Group)<br />

15038 Zovirax Aciclovirum Cream 50 mg/g Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

15041 Zovirax Aciclovirum Eye ointment 30 mg/ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

15039 Zovirax Aciclovirum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

15040 Zovirax Aciclovirum Lyophilisate for<br />

solution for<br />

intravenous infusion<br />

250 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

500 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

15045 Zovirax Aciclovirum Oral suspension 200 mg/5ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

15042 Zovirax Aciclovirum Tablets 200 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

15043 Zovirax Aciclovirum Tablets 400 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

15044 Zovirax Aciclovirum Tablets 800 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

15046 Zovirax DS Forte Aciclovirum Oral suspension 400 mg/5 ml Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

15047 Zovirax S Aciclovirum Tablets for oral<br />

suspension<br />

800 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/12/08<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

30/04/04<br />

27/06/05<br />

30/04/04<br />

27/06/05<br />

27/06/05<br />

30/06/04<br />

31/07/04<br />

15048 Zoxon 1 Doxazosinum Tablets 1 mg Lečiva a.s. 5/07/06<br />

15049 Zoxon 2 Doxazosinum Tablets 2 mg Lečiva a.s. 5/07/06<br />

15050 Zoxon 4 Doxazosinum Tablets 4 mg Lečiva a.s. 5/07/06<br />

15051 Zucon Fluconazolum Capsules 50 mg IVAX PHARMA POLAND Sp.<br />

z o.o.<br />

15052 Zucon Fluconazolum Capsules 100 mg IVAX PHARMA POLAND Sp.<br />

z o.o.<br />

15053 Zucon Fluconazolum Capsules 150 mg IVAX PHARMA POLAND Sp.<br />

z o.o.<br />

15054 Zucon Fluconazolum Capsules 200 mg IVAX PHARMA POLAND Sp.<br />

z o.o.<br />

15055 Zyban Bupropionum Film-coated, prologed<br />

release tablets<br />

15056 Zyklomat pulse set Lutrelef 0,8 Gonadorelinum Powder and solvent<br />

for solution for<br />

injection<br />

150 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

31/05/05<br />

0.8 mg Ferring GmbH 31/05/04


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1391<br />

Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date<br />

15057 Zyklomat pulse set Lutrelef 3,2 Gonadorelinum Powder and solvent<br />

for solution for<br />

injection<br />

3.2 mg Ferring GmbH 31/05/04<br />

15058 Zyllt Clopidogrelum Film-coated tablets 75 mg KRKA Polska Sp. z o.o. 31/12/08<br />

15059 Zyloram Citalopramum Film-coated tablets 10 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

15060 Zyloram Citalopramum Film-coated tablets 20 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

15061 Zyloram Citalopramum Film-coated tablets 40 mg Ranbaxy Laboratoires Ltd. 31/12/08<br />

15062 Zyloric Allopurinolum Tablets 100 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

15063 Zyloric Allopurinolum Tablets 300 mg Glaxo Wellcome Group<br />

Glaxo Wellcome House<br />

15064 Zymafluor Natrii fluoridum Tablets 0.25 mg Novartis Consumer Health<br />

S.A.<br />

15065 Zymafluor Natrii fluoridum Tablets 1 mg Novartis Consumer Health<br />

S.A.<br />

15066 Zymafluor 0,114 % Natrii fluoridum Drops 0.114 % Novartis Consumer Health<br />

S.A.<br />

30/06/04<br />

30/06/04<br />

31/12/08<br />

31/12/08<br />

31/12/08<br />

15068 Zyprexa Olanzapinum Film-coated tablets 10 mg Eli Lilly and Company Ltd 31/12/07<br />

15069 Zyprexa Olanzapinum Film-coated tablets 15 mg Eli Lilly and Company Ltd 31/12/08<br />

15070 Zyprexa Olanzapinum Film-coated tablets 2.5 mg Eli Lilly and Company Ltd 29/10/06<br />

15071 Zyprexa Olanzapinum Film-coated tablets 20 mg Eli Lilly and Company Ltd 29/10/06<br />

15072 Zyprexa Olanzapinum Film-coated tablets 5 mg Eli Lilly and Company Ltd 31/12/07<br />

15067 Zyprexa Olanzapinum Powder for solution<br />

for injection<br />

10 mg Eli Lilly Nederland B.V. 21/03/07<br />

15075 Zyrtec Cetirizinum Film-coated tablets 10 mg UCB S.A. Pharma Sector 30/06/04<br />

15073 Zyrtec Cetirizinum Oral drops, solution 10 mg/ml UCB S.A. Pharma Sector 30/06/04<br />

15074 Zyrtec Cetirizinum Oral solution 1 mg/ml UCB S.A. Pharma Sector 31/12/08<br />

15078 Zyvoxid Linezolidum Film-coated tablets 600 mg Pharmacia & Upjohn Co. 6/12/06<br />

15076 Zyvoxid Linezolidum Granules for oral<br />

solution<br />

15077 Zyvoxid Linezolidum Solution for<br />

intravenous infusion<br />

15079 Z˙el borowinowy(proponowana<br />

nazwa: reumogel)<br />

Wodny wycia˛g<br />

borowinowy<br />

20 mg/ml Pharmacia & Upjohn Co. 6/12/06<br />

2 mg/ml Pharmacia A.B. 6/12/06<br />

Gel Przedsie˛biorstwo<br />

Farmaceutyczne ‘SULPHUR<br />

— ZDRÓJ’ EXIM Busko-Zdrój<br />

31/12/08<br />

15080 Z˙el do jamy ustnej Gel WALA-Heilmittel GmbH 24/05/07<br />

15081 Z˙el na blizny Gel WALA-Heilmittel GmbH 24/05/07<br />

15082 Z˙el na oparzenia Gel WALA-Heilmittel GmbH 24/05/07<br />

15083 Z˙el szałwiowy stomatologiczny Pampa, Piaseczno 14/10/06<br />

15084 Z˙elatyna Interforum Pharma Sp. z o.o.,<br />

Kraków<br />

19/07/05<br />

15085 Z˙elatyna Pharma Zentrale 19/07/05


EN<br />

1392 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Appendix B<br />

referred to in Chapter 6, Section B, Subsection I, point 1 of Annex XII (*)<br />

List of red meat establishments in transition, including shortcomings and deadlines for the correction of these<br />

shortcomings<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship, Dolnos´la˛skie<br />

1. 02080201 P.P.H. CEES – POL spółka<br />

jawna<br />

2. 02120206 Zakład Mie˛sny Sp. jawna D.M.<br />

Niebieszczańscy<br />

3. 02190319 PEKPOL – Wytwórnia We˛dlin i<br />

Konserw Sp. z o.o<br />

4. 02200301 Zakład Przetwórstwa Mie˛snego<br />

‘Tarczyński’ Sp. z o.o<br />

(*) For the text of Annex XII see OJ L 236, 23.9.2003, p. 875.<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e),<br />

and (g)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b) and (c)<br />

Annex I, Chapter III, point 15(a), (b), (c) and<br />

(d)<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d)<br />

and (e)<br />

Annex A, Chapter I, points 4 and 5<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(c)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 11<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(e)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f) and (g)<br />

Annex I, Chapter I, point 4(b) and (c)<br />

Annex I, Chapter I, point 5<br />

Annex I, Chapter IV, point 16(a)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e) and (f)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a) and (e)<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 5, 8, 11<br />

Annex I, Chapter III, point 15(c) and (d)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a) and (e)<br />

Annex A, Chapter I, points 4, 9, 11, 14<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (e)<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 5, 8, 11<br />

Date of full<br />

compliance<br />

31.7.2006<br />

31.10.2007<br />

31.12.2007<br />

30.11.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1393<br />

No Vet. No Name of the establishment Shortcomings<br />

5. 02240301 P.P.H. ‘HE-MA’ Przetwórnia<br />

Mie˛sa<br />

Annex I, Chapter III, point 15(c)<br />

Annex I, Chapter IV, point 16(a)<br />

Annex I, Chapter IV, point 17(a)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c) and (g)<br />

Annex I, Chapter I, points 9, 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(d)<br />

Annex A, Chapter I, points 11, 12, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(c) and (g)<br />

Annex I, Chapter I, points 9, 11, 12<br />

6. 02260202 Zakład Mie˛sny ‘NALPOL’ Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e) and (g)<br />

Annex I, Chapter I, point 2(a) and (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 5, 11<br />

Directive 94/65:<br />

Annex I Chapter I, point 1(a), (b) and (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (d), (g) and<br />

(h)<br />

Annex A, Chapter I, points 4, 5, 6, 8, 11<br />

Annex B, Chapter I, point 2<br />

Voivodship Kujawsko-Pomorskie<br />

7. 04020201 MASARNIA KARBOWO<br />

BRYGIDA I MAREK PESTA<br />

8. 04020204 Zakłady Mie˛sne ‘POLMEAT’ Sp.<br />

z o.o<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c) and (g)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, point 9<br />

Annex I, Chapter II, point 14(l)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c)<br />

Annex A, Chapter I, point 12<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 12<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(c)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d)<br />

and (e)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2007<br />

31.12.2005<br />

31.12.2006


EN<br />

1394 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

9. 04040201 PROVIMI POLSKA HOLDING<br />

SP. Z O.O OSNOWO<br />

10. 04050201 Zakład Masarski Helena, Stefan<br />

Romanowscy Miliszewy<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(d)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter II, point 14(c)<br />

Annex I, Chapter III, point 15(d)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(c)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d)<br />

and (e)<br />

Annex A, Chapter I, points 4, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 8, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(g), (h), (i)<br />

Annex I, Chapter III, point 15(b)<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 4, 15<br />

11. 04610201 Z. M. BYD MEAT S. A. Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e) and<br />

(g)<br />

Annex I, Chapter I, point 4(b) and (c)<br />

Annex I, Chapter I, points 5, 8, 11, 12<br />

Annex I, Chapter II, point 14(h)<br />

Annex I, Chapter IV, point 17(a) and (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d)<br />

and (e)<br />

Annex A, Chapter I, points 4, 9, 11, 15<br />

Voivodship, Lubelskie<br />

12. 06080204 ‘SŁOMKA’ Sp. j. Andrzej<br />

Słomka, Waldemar Słomka<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e) and (g)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, points 10, 11, 12, 13<br />

Annex I, Chapter II, point 14(b), (c), (e), (g),<br />

(h), and (i)<br />

Annex I, Chapter III, point 15(b)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (d) and (e)<br />

Annex A, Chapter I, points 5, 11, 12, 15<br />

Date of full<br />

compliance<br />

30.11.2006<br />

30.9.2006<br />

30.9.2006<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1395<br />

No Vet. No Name of the establishment Shortcomings<br />

13. 06080201 Zakład Przetwórstwa<br />

Mie˛snego<br />

Boz˙ena i Kazimierz<br />

Wójcik<br />

14. 06080301 ‘GIZET’ Sp. j.<br />

I. Galińska, B. Galińska<br />

15. 06610303 Zakład Przetwórstwa<br />

Mie˛snego<br />

‘Tadeusz’ Sp. z o.o<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a) and (g)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c), (d) and (e)<br />

Annex I, Chapter I, points 10, 11, 12, 13<br />

Annex I, Chapter III, point 15(a), (b), (c) and<br />

(d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(a) and (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(c), (e) and (h)<br />

Annex A, Chapter I, points 4, 5, 8, 11, 12,<br />

13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (e) and (g)<br />

Annex I, Chapter I, point 2(a) and (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 5, 9, 10, 11,<br />

12, 13<br />

Annex I, Chapter III, point 15(a) and (b)<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

Annex I, Chapter IV, point 17(a) and (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (d) and (e)<br />

Annex A, Chapter I, points 4, 5, 6, 8, 11,<br />

12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(d)<br />

Annex A, Chapter I, points 4, 7, 8, 9, 11,<br />

13, 14<br />

16. 06010301 PPHU ‘Demex’ Sp. z o.o Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (d), (e),<br />

(g) and (h)<br />

Annex A, Chapter I, points 4, 5, 8, 9, 10,<br />

12, 13, 14, 15<br />

17. 06140201 Zakłady Mie˛sne<br />

‘Końskowola’<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b) and (c)<br />

Annex A, Chapter I, point 9<br />

Annex B, Chapter I, point 2<br />

18. 06020201 Masarnia B.J. Nies´cior Directive 64/433:<br />

Annex I, Chapter II, point 14(c) and (d)<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2007<br />

31.12.2005<br />

31.12.2005<br />

31.12.2006<br />

31.10.2007


EN<br />

1396 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

19. 06020207 PPH ‘MISA – W’<br />

Andrzej Wasa˛g<br />

20. 06020203 Zakłady Mie˛sne w<br />

Biłgoraju<br />

Czesław Sobczak<br />

21. 06020208 Zakład Mie˛sny<br />

‘Romex’<br />

Romuald Chołota<br />

22. 06070201 Zakład Przetwórstwa<br />

Mie˛snego<br />

‘MAX’ Sp. j.<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g) and (h)<br />

Annex A, Chapter I, points 4, 6, 8, 9, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 5, 8, 11, 12<br />

Annex I, Chapter II, point 14(d)<br />

Annex I, Chapter III, point 15(c) and (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 4, 8, 9, 11, 12,<br />

15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e) and (g)<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 8, 9, 10, 11, 12<br />

Annex I, Chapter II, point 14(g), (h) and (j)<br />

Annex I, Chapter III, point 15(a), (b), (c) and<br />

(d)<br />

Annex I, Chapter IV, point 17(a) and (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (c) and (e)<br />

Annex A, Chapter I, points 4, 8, 9, 11, 12,<br />

14, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e) and (g)<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Annex I, Chapter I, points 8, 9, 10, 11, 12<br />

Annex I, Chapter II, point 14(g), (h) and (j)<br />

Annex I, Chapter III, point 15(a), (b), (c) and<br />

(d)<br />

Annex I, Chapter IV, point 17(a) and (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (c) and (e)<br />

Annex A, Chapter I, points 4, 8, 9, 11, 12,<br />

14, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f)<br />

and (g)<br />

Annex I, Chapter I, point 4(b), (c) and (e)<br />

Date of full<br />

compliance<br />

31.10.2007<br />

30.9.2007<br />

30.9.2007<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1397<br />

No Vet. No Name of the establishment Shortcomings<br />

23. 06110206 Zakład Mie˛sny<br />

‘Wierzejki’<br />

Jan i Marek Zdanowscy<br />

24. 06050201 Z.P.M.<br />

‘MATTHIAS’ Sp. z o.o<br />

25. 06180210 Zakład Przetwórstwa<br />

Mie˛snego Sp.j.<br />

Wre˛biak, Witkowski<br />

Annex I, Chapter I, points 5, 8, 11, 12, 13<br />

Annex I, Chapter II, point 14(b), (c), (d), (e),<br />

(g), (h), (i), (k) and (l)<br />

Annex I, Chapter III, point 15(d)<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b) and (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(d) and (e)<br />

Annex A, Chapter I, points 8, 11, 13, 14<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e) and (g)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 4(b) and (e)<br />

Annex I, Chapter I, points 10, 11, 12<br />

Annex I, Chapter II, point 1(h)<br />

Annex I, Chapter II, point 14(b), (c), (h) and<br />

(i)<br />

Annex I, Chapter III, point 15(c) and (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 8, 11, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 4(c) and (e)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter III, point 15(b), (c) and (d)<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

Annex I, Chapter IV, point 17(a) and (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c) and (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (c) and (d)<br />

Annex A, Chapter I, points 4, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f) and (g)<br />

Annex I, Chapter I, point 2(a) and (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d)<br />

and (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9, 10,<br />

11, 12, 13<br />

Date of full<br />

compliance<br />

31.12.2005<br />

31.12.2006<br />

31.12.2007


EN<br />

1398 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

26. 06200203 ‘Agrozam’ Sp. z o.o Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e) and (h)<br />

Annex A, Chapter I, points 4, 5, 11, 12, 15<br />

27. 06090202 PHU Kowalczykowski<br />

Stanislaw<br />

Voivodship, Lubuskie<br />

28. 08010101 Masarnia Podmiejska Sp. j.<br />

Nowe Polichno<br />

Directive 64/433:<br />

Annex I, Chapter III, point 15(a), (b), (c) and<br />

(d)<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(b), (c), (d), (e),<br />

(g) and (h)<br />

Annex A, Chapter I, points 4, 8, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e) and (g)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter II, point 14(a), (c), (e) and<br />

(l)<br />

Annex I, Chapter IV, point 17(b)<br />

29. 08610305 Masarnia Podmiejska Sp. j. Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (c), (e) and (g)<br />

Annex I, Chapter I, point 4(b) and (c)<br />

Annex I, Chapter I, points 9, 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (c), (d) and<br />

(e)<br />

Annex A, Chapter I, points 4, 6, 11, 12, 15<br />

30. 08020204 Zakład Ubojowo-Masarniczy<br />

‘BEKON’ Stanisław Suder<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f)<br />

and (g)<br />

Annex I, Chapter I, point 2(a) and (b)<br />

Annex I, Chapter I, point 4(c), (d) and (e)<br />

Annex I, Chapter I, points 9, 11, 12<br />

Annex I, Chapter II, point 14(b), (c), (e), (h),<br />

(i), (j) and (l)<br />

Annex I, Chapter III, point 15(b), (c) and (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 94/64:<br />

Annex I, Chapter I, 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1,<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 4, 7, 8, 11, 15<br />

Annex B, Chapter I, point 2<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.10.2007<br />

30.6.2006<br />

30.4.2007<br />

30.9.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1399<br />

No Vet. No Name of the establishment Shortcomings<br />

31. 08030201 Rzez´nictwo i We˛dliniarstwo<br />

Augustyn Szczerba<br />

32. 08040204 Biuro Handlowe<br />

‘AMBERMAX’ Sp. z o.o<br />

33. 08040315 Gminna Spółdzielnia<br />

‘Samopomoc Chłopska’<br />

‘DOBROSŁAWA’<br />

Zakład Mie˛sny<br />

34. 08040205 UBOJNIA DOBROSŁAWA<br />

Sp. z o.o<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f) and (g)<br />

Annex A, Chapter I, points 5, 8, 11, 12, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

and (f)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a) and (b)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter II, point 14(c), (e), (h) and<br />

(k)<br />

Annex I, Chapter III, point 15(a), (b) and (d)<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e) and (h)<br />

Annex A, Chapter I, points 4, 7, 8, 11, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex I, Chapter I, point 4(c) and (e)<br />

Annex I, Chapter I, points 9, 11, 12<br />

Annex I, Chapter III, point 15(b), (c) and (d)<br />

Annex I, Chapter IV, point 17(a) and (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c) and (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d)<br />

and (e)<br />

Annex A, Chapter I, points 4, 8, 11, 12, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

and (f)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(d)<br />

Annex I, Chapter I, points 5, 10, 12<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

Annex I, Chapter IV, point 17(a) and (b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e)<br />

and (g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11, 12, 13<br />

Annex I, Chapter II, point 14(c) and (e)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter I, point 17(b)<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.10.2007<br />

31.10.2007<br />

30.9.2007


EN<br />

1400 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

35. 08040206 AGROMAS Sp. z o.o Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f) and (g)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 4(a), (b) and (e)<br />

Annex I, Chapter I, points 5, 9, 11, 12<br />

Annex I, Chapter II, point 14(b), (c), (e), (f),<br />

(h) and (l)<br />

Annex I, Chapter III, point 15(a), (b) and (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(a) and (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(b), (c) and (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

and (e)<br />

Annex A, Chapter I, points 6, 8, 11, 12, 15<br />

36. 08040306 Zakład Przetwórstwa<br />

Mie˛snego ‘Sława’<br />

Sp. z o.o<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e) and<br />

(g)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c) and (e)<br />

Annex I, Chapter I, points 5, 9, 11<br />

Annex I, Chapter III, point 15(a), (b) and (d)<br />

Annex I, Chapter IV, point 16(a) and (b)<br />

Annex I, Chapter IV, point 17(a) and (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c) and (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d)<br />

and (f)<br />

Annex A, Chapter I, points 4, 5, 8, 11, 12<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

and (f)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a) and (d)<br />

Annex I, Chapter I, points 9, 11<br />

37. 08060201 Masarnia Roman Duszyński Directive 64/433:<br />

Annex I, Chapter I, point 1(c)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter III, point 15(b)<br />

Annex I, Chapter IV, point 16(b)<br />

38. 08060203 Zakład Masarniczy<br />

Stanisław Przewoz´ny<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter II, point 14(c), (e), (k)<br />

Date of full<br />

compliance<br />

30.6.2007<br />

30.9.2007<br />

31.12.2006<br />

30.6.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1401<br />

No Vet. No Name of the establishment Shortcomings<br />

39. 08070201 Zakład Przetwórstwa<br />

Mie˛snego ‘WARTA’<br />

40. 08080201 Zakłady Mie˛sne<br />

‘TARGED’ Sp. z o.o<br />

41. 08090202 Przedsie˛biorstwo<br />

‘DEREKS’ Sp. z o.o<br />

Annex I, Chapter III, point 15(d)<br />

Annex I, Chapter IV, point 16(b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(d)<br />

Annex A, Chapter I, point 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(g)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter II, point 14(c)<br />

Annex I, Chapter III, point 15(b), (c)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b), (c), (e)<br />

Annex A, Chapter I, points 4, 6, 11, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(g)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter II, point 14(b), (c), (e), (h),<br />

(k)<br />

Annex I, Chapter III, point 15(c), (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (e)<br />

Annex A, Chapter I, points 4, 11<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 8, 11, 12<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(a)<br />

Annex I, Chapter IV, point 17(a)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(c), (d)<br />

Date of full<br />

compliance<br />

30.6.2007<br />

30.9.2007<br />

31.10.2007


EN<br />

1402 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

42. 08100101 Przedsie˛biorstwo<br />

Produkcyjno Handlowe<br />

‘Rolvex’<br />

Sp. z o.o<br />

43. 08100204 Zakład Masarniczy<br />

‘Czernicki i syn’<br />

Jarosław Czernicki<br />

44. 08110201 Gruszczyński-Cierlukiewicz<br />

sp. j. Zakłady Handlowo-<br />

Produkcyjne ‘Brodex’ w<br />

Brodach<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g)<br />

Annex A, Chapter I, points 4, 6, 7, 8, 9, 11,<br />

15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 5, 8, 11, 12<br />

Annex I, Chapter II, point 14(c), (e)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (c), (e), (f), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 8, 9, 11, 13,<br />

14, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 5, 7, 8, 11, 12<br />

Annex I, Chapter II, point 14(f)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g)<br />

Annex A, Chapter I, points 4, 5, 8, 9, 11, 15<br />

Annex B, Chapter I, point 2<br />

Date of full<br />

compliance<br />

31.12.2007<br />

30.9.2007<br />

31.1.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1403<br />

No Vet. No Name of the establishment Shortcomings<br />

45. 08110205 Kunickie Zakłady<br />

Mie˛sne I&T Sp. z o.o<br />

Voivodship, Lódzkie<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 11, 12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (g), (h), (i), (j), (l)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(d), (e)<br />

Annex A, Chapter I, points 8, 11, 13, 14, 15<br />

46. 10060105 ZPM ‘GROT’ Ubojnia Trzody Directive 64/433:<br />

Annex I, Chapter I, point 1(b), (e)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, points 5, 8, 10, 11, 12,<br />

13<br />

Annex I, Chapter II, point 14(b), (c), (e), (f),<br />

(h), (l)<br />

47. 10060315 ZPM ‘GROT’ S.J. Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 10, 13<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 4, 8, 13, 14<br />

Annex B, Chapter I, point 2<br />

48. 10060308 ZAKLAD PRZETWORSTWA<br />

MIESNEGO<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e), (g)<br />

Annex I, Chapter I, point 4(b), (c), (d)<br />

Annex I, Chapter I, point 11, 12<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Date of full<br />

compliance<br />

30.9.2007<br />

31.12.2007<br />

30.9.2007<br />

31.12.2007


EN<br />

1404 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(c), (d), (e)<br />

Annex A, Chapter I, points 4, 7, 8, 11, 14,<br />

15<br />

49. 10060215 ZMS ‘S´ CIBIORÓW’ Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 5, 11, 12<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1,<br />

Annex A, Chapter I, point 2(c), (d), (e)<br />

Annex A, Chapter I, points 4, 8, 11, 15<br />

50. 10080301 ‘BARTCZAK’ Directive 64/433:<br />

Annex I, Chapter I, point 1(d)<br />

Annex I, Chapter I, point 4(e)<br />

Annex I, Chapter I, points 5, 9, 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f)<br />

Annex A, Chapter I, points 4, 11, 12, 15<br />

51. 10610307 PPU ‘JUMAR’ Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 8, 9, 11, 12, 13<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f)<br />

Annex A, Chapter I, points 4, 8, 9, 10, 11,<br />

12, 13, 14, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, point 8, 9, 11, 12, 13<br />

Annex I, Chapter III, point 15(b), (c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

30.4.2007<br />

30.11.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1405<br />

No Vet. No Name of the establishment Shortcomings<br />

52. 10030303 Zakład We˛dliniarski<br />

Władysław Gabrysiak<br />

53. 10020202 Zakład Przetw. Mie˛sn.<br />

‘KONIÂREK’<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (d), (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(e)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter III, point 15(c), (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c)<br />

Annex A, Chapter I, points 8, 11 and 15<br />

Annex B, Chapter I, point 2<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 8, 11, 12, 14<br />

54. 10610311 Zakłady Mie˛sne ‘We˛dzonka’ Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 8, 12, 13<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 6, 8, 9, 13,<br />

14, 15<br />

Annex B, Chapter I, point 2<br />

Voivodship, Małopolskie<br />

55. 12030201 P.P.H.U. ‘Hurtimex’ Directive 64/433:<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 8, 10, 11, 12, 13<br />

Annex I, Chapter II, point 14(a), (d), (e), (f),<br />

(g), (h)<br />

Annex I, Chapter III, point 15(a)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e), (h)<br />

Annex A, Chapter I, points 4, 8, 11, 12, 15<br />

Date of full<br />

compliance<br />

31.12.2007<br />

30.9.2007<br />

31.5.2007<br />

31.12.2007


EN<br />

1406 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

56. 12030203 Zakład Przetwórstwa<br />

Mie˛snego s.j.<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, points 9, 11, 12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (g), (h), (k)<br />

Annex I, Chapter III, point 15(c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(h)<br />

Annex A, Chapter I, points 4, 8, 11, 12, 13,<br />

14, 15<br />

Annex B, Chapter I, point 2<br />

57. 12050202 ZPM AMIGO s.j. Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (e)<br />

Annex I, Chapter I, point 11<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(d), (g), (h)<br />

Annex A, Chapter I, point 11<br />

58. 12050301 Zakład Masarski ‘ANGUS’ s.j. Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (f)<br />

Annex I, Chapter I, point 4(e)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter III, point 15(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(g), (h)<br />

Annex A, Chapter I, point 15<br />

59. 12050304 F.P.H.U. ‘ANGELA’ s.j. Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 8, 11<br />

Annex I, Chapter III, point 15(d)<br />

60. 12060329 ‘BOREX-BECON’ s.j. Directive 64/433:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 9, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b), (e)<br />

Annex A, Chapter I, points 4, 8, 12, 15<br />

61. 12060203 Firma ‘ADOZ’ Directive 64/433:<br />

Annex I, Chapter I, point 1(c)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11, 12, 13<br />

Date of full<br />

compliance<br />

31.12.2007<br />

28.2.2007<br />

31.10.2005<br />

31.10.2007<br />

31.8.2007<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1407<br />

No Vet. No Name of the establishment Shortcomings<br />

62. 12070201 Przedsie˛biorstwo<br />

Wielobranz˙owe<br />

‘LASKOPOL’ s.j.<br />

63. 12070108 Zakład Uboju Zwierza˛t<br />

Rzez´nych<br />

64. 12070105 ‘DOBR-MIE˛S’ Zakład<br />

Uboju Zwierza˛t<br />

Rzez´nych<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (d), (e), (g)<br />

Annex A, Chapter I, points 4, 11, 13, 14, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter III, point 15(c), (d)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 8, 11, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 7, 10, 11, 12, 13<br />

Annex I, Chapter II, point 14(a), (c), (e), (f),<br />

(g), (h)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c), (d)<br />

Annex I, Chapter I, points 9, 10, 11, 12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(g), (i), (j), (l)<br />

65. 12620313 Zakład Masarski ‘ZDRÓJ’ s.j. Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(g)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 12<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 4, 6, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(g)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Date of full<br />

compliance<br />

30.6.2005<br />

31.12.2005<br />

30.6.2005<br />

31.12.2007


EN<br />

1408 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

66. 12620314 Zakłady Mie˛sne<br />

Wiesław Les´niak<br />

67. 12100304 Firma Produkcyjno<br />

Handlowa Maria i<br />

Zbigniew Szubryt<br />

Zakład Masarski<br />

Biczyce<br />

Dolne<br />

Annex I, Chapter I, points 5, 12<br />

Annex I, Chapter III, point 15(a), (b), (c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9, 10,<br />

11, 12, 13<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 9,<br />

10, 11, 12, 13, 14, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9, 10,<br />

11, 12, 13<br />

Annex I, Chapter III, point 15(a), (b), (c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 64/433:<br />

Annex I, Chapter I, points 9, 10, 11, 12<br />

Annex I, Chapter III, point 15(c)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, points 8, 11, 12, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, points 9, 11, 12<br />

Annex I, Chapter III, point 15(b), (c)<br />

Annex I, Chapter IV, point 16(a)<br />

Annex I, Chapter IV, point 17(a)<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1409<br />

No Vet. No Name of the establishment Shortcomings<br />

68. 12100311 Handel i Skup Z˙ywca<br />

oraz Mie˛sa Zakład<br />

Rozbioru<br />

Łabowa, Jacek Zaczyk<br />

69. 12100112 P.P.H.U. ‘KWARTET’<br />

Ubojnia Zwierza˛t<br />

70. 12120323 Zakład Przetwórstwa<br />

Mie˛sa, Sp zo.o,<br />

Z. Pr. Chr. ‘BASO’<br />

71. 12160208 Wojnickie Zakłady Mie˛sne<br />

‘MEAT COMPANY’<br />

72. 12160212 Zakład Rolno-Produkcyjny,<br />

Zakład Masarski<br />

73. 12180303 Zakład Przetwórstwa<br />

Mie˛snego, J. Wolas, M.<br />

Kastelik, Sp. z o.o<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, points 9, 10, 12<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 12<br />

Annex I, Chapter II, point 14(a), (d), (f), (g),<br />

(h)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 9, 11<br />

Annex I, Chapter III, point 15(b)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c)<br />

Annex A, Chapter I, points 8, 11<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (e)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b) (e)<br />

Annex A, Chapter I, points 8, 11, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 8, 9, 12<br />

Annex I, Chapter III, point 15(b), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e), (g)<br />

Annex A, Chapter I, points 4, 9, 12<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (e), (g)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Date of full<br />

compliance<br />

31.12.2006<br />

30.8.2007<br />

31.12.2007<br />

30.4.2005<br />

30.4.2005<br />

31.12.2007


EN<br />

1410 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter III, point 15(a), (c), (d)<br />

Annex I, Chapter IV, point 16(a)<br />

Annex I, Chapter IV, point 17(a)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (e),<br />

(h)<br />

Annex A, Chapter I, points 4, 8, 11, 15<br />

Annex B, Chapter I, point 2<br />

74. 12180204 ‘Adam Ba˛k – Wieprz’ Sp. z o.o Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter III, point 15(b)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

75. 12180205 Rzez´nictwo-We˛dliniarstwo<br />

J. Tomczyk<br />

76. 12180307 Rzez´nictwo-We˛dliniarstwo<br />

Maciej Szlagor<br />

77. 12150304 Zakłady Mie˛sne<br />

‘MIS´ KOWIEC’<br />

s.j.<br />

78. 12190104 Ubojnia Zwierza˛t<br />

Rzez´nych<br />

Skup i Sprzedaz˙ Ćwierci,<br />

Jacek S´ liwa<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, point 12<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 5, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (e)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, points 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (e), (g), (h)<br />

Annex A, Chapter I, points 8, 11, 15<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (c), (d), (e)<br />

Annex A, Chapter I, points 4, 7, 11, 13, 14,<br />

15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e)<br />

Annex I, Chapter I, point 4(b), (c), (d)<br />

Annex I, Chapter I, points 12, 13<br />

Annex I, Chapter II, point 14(i)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2007<br />

31.12.2007<br />

31.12.2006<br />

31.10.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1411<br />

No Vet. No Name of the establishment Shortcomings<br />

79. 12190202 Zakład Przetwórstwa Mie˛snego<br />

w Wieliczce<br />

Sp. z o.o<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e), (f)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, points 6, 7, 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (d), (e), (h)<br />

Annex A, Chapter I, points 4, 8, 11, 15<br />

80. 12190203 F.H.P. ‘GRAJPEK’ s.j. Directive 64/433:<br />

Annex I, Chapter I, point 1(f)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, points 5, 6, 7, 9, 11, 12,<br />

13<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(f)<br />

Annex A, Chapter I, points 4, 6, 8, 10, 11,<br />

12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

81. 12190205 P.P.H.U. ‘RACHOŃ’ s.c. Directive 64/433:<br />

Annex I, Chapter I, point 1(b), (g)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, points 6, 7, 12, 13<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b), (c)<br />

Annex A, Chapter I, points 8, 13, 14, 15<br />

Voivodship, Mazowieckie<br />

82. 14160205 Zakłady Mie˛sne ‘Mazowsze’ Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 12<br />

Annex I, Chapter II, point 14(a), (e)<br />

Annex I, Chapter III, point 15(a), (b), (d)<br />

Annex I, Chapter, IV, 16(a), (b)<br />

Annex I, Chapter, IV, 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (h)<br />

Annex A, Chapter I, points 4, 15<br />

Date of full<br />

compliance<br />

30.6.2007<br />

31.12.2006<br />

31.12.2007<br />

31.12.2007


EN<br />

1412 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

83. 14160201 Przetwórstwo Mie˛sne<br />

‘KOSPOL’<br />

Directive 64/433:<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 8, 11, 15<br />

Annex B, Chapter I, point 2<br />

84. 14300204 Zakład Masarski ‘Zbyszko’ Directive 64/433:<br />

Annex I, Chapter I, point 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 6, 8<br />

Annex B, Chapter I, point 2<br />

85. 14190204 Zakład Masarski ‘Danko’ Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (f), (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, points 8, 11, 12, 13<br />

Annex I, Chapter II, point 14(c), (g), (h)<br />

Annex I, Chapter IV, point 16(b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c)<br />

Directive 77/99:<br />

Annex A, Chapter I, points 9, 11, 13, 15<br />

Annex B, Chapter I, point 2<br />

86. 14190203 Zakład Mie˛sny ‘Carpexim’ s.c. Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 8, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (h), (i),<br />

(l)<br />

Annex I, Chapter IV, point 16(b)<br />

87. 14190303 Zakład Przetwórstwa<br />

Mie˛sa ‘Olewnik-Bis’<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3,<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9, 10,<br />

11, 12, 13<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Date of full<br />

compliance<br />

30.6.2007<br />

31.12.2007<br />

31.12.2006<br />

30.11.2005<br />

31.5.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1413<br />

No Vet. No Name of the establishment Shortcomings<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g)<br />

Annex A, Chapter I, points 4, 7, 8, 9, 11,<br />

12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

88. 14620201 Zakłady Mie˛sne S.A. Directive 64/433:<br />

Annex I, Chapter I, point 1(g)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, point 8, 11<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c)<br />

Annex A, Chapter I, point 11<br />

89. 14090201 ‘Publima’ Sp.J.<br />

Zakład Przetwórstwa<br />

Mie˛sa<br />

90. 14050201 Zakład Produkcyjno-<br />

Handlowy Przetwórstwo<br />

Mie˛sne<br />

Zbigniew Pniewski<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(b), (c), (d)<br />

Annex I, Chapter I, points 8, 12<br />

Annex I, Chapter II, point 14(a), (b), (e), (h)<br />

Annex I, Chapter III, point 15(c), (d)<br />

Annex I, Chapter IV, point 17(a)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 7, 8, 9, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9, 11,<br />

12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (g), (h), (i), (j), (l)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b),<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 9,<br />

13, 14, 15<br />

91. 14170305 Zakład Garmaz˙eryjny Spj Directive 77/99:<br />

Annex A, Chapter I, point 2(a)<br />

Annex A, Chapter I, points 4, 8, 11, 12, 15<br />

92. 14170213 Skup z˙ywca i sprzedaz˙<br />

półtusz, handel mie˛sem i<br />

wyrobami mie˛snymi<br />

Marek Mazek<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Date of full<br />

compliance<br />

30.6.2006<br />

30.9.2005<br />

31.12.2006<br />

31.12.2006<br />

31.12.2007


EN<br />

1414 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

93. 14200308 Zakład Przetwórstwa<br />

Mie˛snego Siedlin<br />

Annex I, Chapter I, point 4(a), (b), (c), (d)<br />

Annex I, Chapter I, points 5, 7, 9, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (h), (i), (j), (l)<br />

Annex I, Chapter III, point 15(a), (b), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f)<br />

Annex A, Chapter I, points 4, 6, 11, 12, 15<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(c), (d), (e)<br />

Annex A, Chapter I, points 4, 6, 8, 11, 12,<br />

15<br />

Annex B, Chapter I, point 2<br />

94. 14350107 ‘CEZAR’ S.J.H. P. U. Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter II, point 14(a), (b), (g), (h),<br />

(k), (l)<br />

Annex I, Chapter IV, point 17(a)<br />

95. 14310306 P.P.H.Hetman<br />

A.J.Lucińscy Zakład<br />

Masarski<br />

96. 14340302 Zakład Masarski<br />

Radzymin s.c.<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 8, 9, 10, 12<br />

Annex I, Chapter III, point 15(a), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(d), (e), (g)<br />

Annex A, Chapter I, points 4, 5, 6, 8, 9, 12,<br />

15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (d), (e), (f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, point 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (e)<br />

Annex B, Chapter I, point 2<br />

Date of full<br />

compliance<br />

30.4.2006<br />

31.12.2006<br />

31.12.2007<br />

31.5.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1415<br />

No Vet. No Name of the establishment Shortcomings<br />

97. 14340310 Zakład Masarski<br />

‘Mareta’ Sp.J.<br />

T.A. Kołbuk<br />

E.W.Kacprzak<br />

98. 14240202 Zakład Przetwórstwa<br />

Mie˛snego s. j. A.<br />

Szczerba, K. Kurowski<br />

99. 14370101 Ubojnia Trzody i Bydła<br />

‘WILPOL’<br />

100. 14370201 Zakład Rzez´niczo<br />

We˛dliniarski S. J. Z.<br />

Motylewski – J, Zaborowski<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (f)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 8, 9, 10, 11, 12,<br />

13<br />

Annex I, Chapter III, point 15(a), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (e), (f),<br />

(h)<br />

Annex A, Chapter I, points 4, 8, 9, 11, 12,<br />

13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(c), (d), (e)<br />

Annex I, Chapter I, points 6, 7, 8, 10, 11,<br />

12, 13<br />

Annex I, Chapter II, point 14(b), (c), (d), (g),<br />

(h), (i), (j), (l)<br />

Annex I, Chapter III, point 15(c), (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(e), (g), (h)<br />

Annex A, Chapter I, points 4, 7, 8, 9, 11,<br />

13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(b), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter II, point 14(b), (h)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (e), (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2007<br />

31.12.2006<br />

31.12.2007


EN<br />

1416 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

101. 1414 03 01 Zakład Przetwórstwa<br />

Mie˛snego<br />

‘SZYNKO-POL’<br />

Spółka zo.o<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(c), (e)<br />

Annex A, Chapter I, point 11, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c), (d)<br />

Annex I, Chapter I, points 9, 10, 11, 12, 13<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 6, 7, 8, 11,<br />

12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

102. 14250309 SP. Z O. O. KAMAR Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(d)<br />

Annex A, Chapter I, points 8, 11, 12, 15<br />

103. 14250301 RADOMSKIE<br />

ZAKŁADY<br />

DROBIARSKIE<br />

‘IMPERSON’ Sp. z o.o<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 4, 6, 7, 8, 11,<br />

12, 15<br />

Annex B, Chapter I, point 2<br />

104. 14250327 Zakład Przetwórstwa Flaków Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (d)<br />

Annex A, Chapter I, points 8, 11, 12<br />

Annex B, Chapter I, point 2<br />

105. 14250310 Zakład Masarski ‘Sadełko’ –<br />

Czapla- S´ winiarski Sp. J<br />

106. 14250104 Zakład Masarski ‘Sadełko’ –<br />

Czapla – S´ winiarski Sp. J<br />

107. 14250201 P.P.H.U. ‘Nasz Produkt’<br />

Z. P. CHR.<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(c), (d), (e)<br />

Annex A, Chapter I, points 4, 6, 7, 8, 9, 11,<br />

15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e), (g)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 8, 11, 12<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (e), (g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 7, 10, 12<br />

Annex I, Chapter II, point 14(d), (l)<br />

Annex I, Chapter III, point 15(d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2007<br />

30.4.2007<br />

31.12.2007<br />

30.11.2007<br />

30.11.2007<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1417<br />

No Vet. No Name of the establishment Shortcomings<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (c), (e)<br />

Annex A, Chapter I, points 4, 7, 9, 14, 15<br />

Annex B, Chapter I, point 2<br />

108. 14250202 Masarnia ELMAS Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(a), (b), (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9, 11<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g)<br />

Annex A, Chapter I, points 6, 10, 11, 12<br />

Voivodship, Opolskie<br />

109. 16010101 PPHU ‘PORKPOL’ Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(g)<br />

Annex I, Chapter I, point 4(b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 7, 9, 11, 12,<br />

13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (h), (j), (k)<br />

110. 16010201 ‘Wojbórz’ Sp. z o.o Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 5, 11, 12<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (c), (d), (e),<br />

(h)<br />

Annex A, Chapter I, point 15<br />

111. 16010301 PPHU ‘PIM’ s.j. Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g), (h)<br />

Annex A, Chapter I, points 4, 8, 12<br />

112. 16040205 Rzez´nictwo-<br />

We˛dliniarstwo<br />

A.P. Sarnowscy<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5, 11<br />

Annex I, Chapter II, point 14(b), (f), (h)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

30.11.2007<br />

31.10.2007<br />

31.10.2007<br />

31.10.2005


EN<br />

1418 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

113. 16060202 Rzez´nictwo-<br />

We˛dliniarstwo J. i S.<br />

Maryniak<br />

114. 16090211 ZPUH Rzez´nictwo<br />

We˛dliniarstwo<br />

115. 16100201 Przedsie˛biorstwo<br />

Produkcyjno Handlowe<br />

Prudnik<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (e), (f)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 8, 9, 11, 12,<br />

13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (g), (h), (i), (l)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1,<br />

Annex A, Chapter I, point 2(a), (e), (f), (g),<br />

(h)<br />

Annex A, Chapter I, points 4, 5, 7, 8, 11,<br />

12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 9, 10, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (g), (j), (l)<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(c), (d), (e), (h)<br />

Annex A, Chapter I, points 4, 7, 8, 11, 12,<br />

13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, point 8<br />

Directive 77/99:<br />

Annex B, Chapter I, point 2<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.10.2006<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1419<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship, Podkarpackie<br />

116. 18030203 Firma Produkcyjno –<br />

Handlowa ‘MAXPOL’<br />

117. 18030210 Zakłady Mie˛sne Spółka<br />

Akcyjna<br />

118. 18030301 Wytwórnia Salami<br />

LGLOOMEAT-<br />

Sokołów Sp. z o.o<br />

119. 18030309 Przetwórnia Mie˛sa PPM<br />

‘Taurus’<br />

120. 18050304 Zakład Masarski ‘Trio’<br />

Spółka jawna<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter II, point 14(a)<br />

Annex I, Chapter III, point 15(d)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (e)<br />

Annex A, Chapter I, points 4, 8, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 9, 11, 13<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (d), (e)<br />

Annex A, Chapter I, points 4, 7, 8, 11, 12,<br />

13, 14<br />

Directive 77/99:<br />

Annex A, Chapter I, points 4, 11<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 9, 10, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, points 4, 12, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter III, point 15(d)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (e)<br />

Annex A, Chapter I, points 4, 11, 15<br />

121. 18070301 Zakład Masarski KON-BIT Directive 64/433:<br />

Annex I, Chapter I, points 10, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 15<br />

122. 18070304 Marsburger Sp. z o.o Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5, 10, 11, 12<br />

Annex I, Chapter III, point 15(b)<br />

Date of full<br />

compliance<br />

31.3.2006<br />

31.10.2006<br />

30.9.2005<br />

31.12.2005<br />

30.4.2006<br />

31.10.2007<br />

31.12.2005


EN<br />

1420 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

123. 18110301 ZPM ‘Mikowski –<br />

Krzystyniak’ s.j.<br />

124. 18110302 Firma Produkcyjno-Handlowa<br />

Andrzej Kurek<br />

125. 18110307 Zakład Mie˛sny<br />

Dobrowolscy<br />

Sp. z o.o<br />

126. 18150202 Przedsie˛biorstwo<br />

Produkcji, Handlu i<br />

Usług ‘Kabanospol’<br />

127. 18160204 Zakłady Mie˛sne<br />

‘Dworak’<br />

128. 18630307 Zakład Produkcji<br />

Masarskiej<br />

‘Społem’ PSS<br />

Voivodship, Podlaskie<br />

Annex I, Chapter IV, point 16(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 11, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 11<br />

Directive 77/99:<br />

Annex A, Chapter I, point 15<br />

Directive 64/433:<br />

Annex I, Chapter III, point 15(a), (b)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(d), (e), (g)<br />

Annex A, Chapter I, point 4, 8, 11, 12, 15<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 8, 9, 11,<br />

12, 13, 14<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, point 12<br />

Directive 77/99:<br />

Annex A, Chapter I, points 4, 8, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (c), (g)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, points 8, 12<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1,<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 4, 8, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 12<br />

Directive 77/99:<br />

Annex A, Chapter I, points 4, 15<br />

129. 20050201 Zakład Mie˛sny Rolmak Plus Directive 64/433:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11, 12, 13<br />

Annex I, Chapter II, point 14(b), (c), (e), (g),<br />

(h), (j)<br />

Annex I, Chapter III, point 15(d)<br />

Date of full<br />

compliance<br />

31.12.2006<br />

30.6.2007<br />

30.11.2007<br />

31.1.2005<br />

30.9.2007<br />

30.9.2007<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1421<br />

No Vet. No Name of the establishment Shortcomings<br />

130. 20040201 Zakład Przetwórstwa<br />

Mie˛snego ‘Zagłoba’ Sp.J<br />

131. 20040202 Zakład Przemysłu<br />

Mie˛snego ‘Europa’ S. i<br />

Z. Zielińscy Sp. J<br />

132. 20080101 Rzez´nia Braci Szypcio<br />

Sp. Jawna<br />

133. 20140101 MIE˛SROL – Ubojnia Bydła,<br />

Trzody R. Tocicki<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (h)<br />

Annex A, Chapter I, points 4, 7, 8, 11, 12,<br />

15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 5, 11, 12<br />

Annex I, Chapter II, point 14(b), (c), (e), (h),<br />

(i), (j)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1,<br />

Annex A, Chapter I, point 2(c), (d), (e)<br />

Annex A, Chapter I, points 11, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 5, 12<br />

Annex I, Chapter II, point 14(b), (c), (d), (e),<br />

(f), (i)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (e)<br />

Annex A, Chapter I, point 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter II, point 14(i)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(c), (d)<br />

Annex I, Chapter I, points 8, 9, 10, 12<br />

Annex I, Chapter II, point 14(g), (l)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2007<br />

31.12.2005<br />

31.12.2005


EN<br />

1422 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

134. 20140103 Ubojnia Trzody i Bydła<br />

W. Gołaszewski,<br />

M. Duchnowski<br />

135. 20140201 .P.H. MEAT – POL M.<br />

Sasinowski, J. Rykaczewski<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(d)<br />

Annex I, Chapter I, points 8, 11, 12<br />

Annex I, Chapter II, point 14(c)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 9, 10, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(f), (g), (h), (i), (j), (l)<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 11, 12, 15<br />

Annex B, Chapter I, point 2<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 8, 9, 10, 11, 12<br />

Annex I, Chapter III, point 15(a), (c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

136. 20140204 Zakłady Mie˛sne ‘NETTER’ Directive 64/433:<br />

Annex I, Chapter I, point 1(c)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 8, 10, 11, 12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(f), (h), (i)<br />

Annex I, Chapter III, point 15(c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(c), (e)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, point 8, 10, 11, 12<br />

Annex I, Chapter III, points 15(a), (c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter I, point 17(a), (b)<br />

Date of full<br />

compliance<br />

30.4.2006<br />

31.12.2005<br />

31.1.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1423<br />

No Vet. No Name of the establishment Shortcomings<br />

137. 20610202 Zakład Mie˛sny ‘LUX’<br />

s.c. J.TR.Kazimierowicz<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 12, 13<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 6, 8, 11, 13,<br />

14, 15<br />

Annex B, Chapter I, point 2<br />

138. 20060206 PPHU ‘LEMIR’ Directive 64/433:<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter II, point 14(c)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 9,<br />

11, 12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

139. 20110201 Przetwórstwo Mie˛sne<br />

ANHED Sp. z o.o<br />

Voivodship, Pomorskie<br />

140. 22020207 Zakład Przetwórstwa<br />

Mie˛snego<br />

Jan Wnuk – Lipiński<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (c), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c), (d)<br />

Annex I, Chapter I, points 5, 11, 12, 13<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (c), (d), (g),<br />

(h)<br />

Annex A, Chapter I, points 4, 5, 7, 8, 11,<br />

13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (d), (e),<br />

(g), (h)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2006<br />

30.6.2007<br />

31.12.2005


EN<br />

1424 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex A, Chapter I, points 8, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

141. 22040301 Masarnia Alicja Andrzej Majer Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (c), (e)<br />

Annex I, Chapter I, points 5, 7, 9, 11, 12<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (e),<br />

(g), (h)<br />

Annex A, Chapter I, points 4, 5, 8, 11, 12,<br />

15<br />

142. 22040302 PPH ‘MASA’ S.J. Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 11, 12,<br />

13<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 9,<br />

10, 11, 12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

143. 22040306 Zakład Przetwórstwa<br />

Mie˛snego<br />

Jerzy Labuda<br />

144. 22630301 Zakład Produkcji<br />

Masarsko-Garmaz˙eryjnej<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (c), (d), (e)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(a), (b), (d)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter III, point 15(b)<br />

Annex I, Chapter IV, point 16(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (d), (e), (g),<br />

(h)<br />

Annex A, Chapter I, points 6, 7, 8, 11<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (g)<br />

Annex I, Chapter I, point 4(b), (d)<br />

Date of full<br />

compliance<br />

31.5.2007<br />

31.5.2007<br />

31.10.2007<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1425<br />

No Vet. No Name of the establishment Shortcomings<br />

145. 22630302 Zakład Przetwórstwa<br />

Mie˛snego<br />

M.Korganowski<br />

146. 22120303 Zakład Przetwórstwa<br />

Mie˛snego<br />

M.Korganowski<br />

Voivodship, S´ la˛skie<br />

147. 24020203 Rzez´nictwo i Handel<br />

Stanisław Kapecki<br />

148. 24020308 Zakład Przetwórstwa<br />

Mie˛snego<br />

Józef Bozek<br />

149. 24020310 Zakład Przetwórstwa<br />

Mie˛snego<br />

HANDEREK SJ<br />

Annex I, Chapter I, points 5, 8, 9, 10, 11,<br />

12, 13<br />

Annex I, Chapter III, point 15(d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d)<br />

Annex A, Chapter I, point 7<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex A, Chapter I, points 4, 5, 7, 8, 11,<br />

12, 13, 14<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 10, 11, 13<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex I, Chapter I, point 2(a), (c), (d) (e)<br />

Annex A, Chapter I, points 4, 6, 7, 8, 11,<br />

12, 13, 14<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (c)<br />

Annex I, Chapter I, points 8, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (d)<br />

Annex I, Chapter I, points 9, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a)<br />

Annex I, Chapter I, point 4(e)<br />

Annex I, Chapter I, points 9, 11, 12<br />

Annex I, Chapter III, point 15(d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a)<br />

Annex A, Chapter I, points 11, 12, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(g)<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 8, 9, 10, 11,<br />

12, 13<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2007<br />

31.12.2007<br />

31.5.2007<br />

31.12.2006


EN<br />

1426 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

150. 24020311 Zakład Przetwórstwa<br />

Mie˛snego<br />

‘KAMWEX’ s. c.<br />

151. 24020313 Przetwórstwo Mie˛sno –<br />

We˛dliniarskie<br />

‘Musiał Bestwinka’<br />

152. 24020320 Zakład Przetwórstwa<br />

Mie˛snego spolka Jawna<br />

F. Czernin, U. Skrokol<br />

153. 24020328 Przetwórstwo Mie˛sne<br />

Emil Droń<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter I, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 4, 6, 8, 9, 11,<br />

12, 13, 14, 15<br />

Annex B, Chapter IV, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 8, 9, 10, 11, 12<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 17(a)<br />

Directive 64/433:<br />

Annex I, Chapter I, points 9, 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, points 11, 12, 14, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 11, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter III, point 15(a)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (e)<br />

Annex A, Chapter I, points 11, 15<br />

154. 24610311 ‘OAZA’ Sp. z o.o Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(g)<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter III, point 15(c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 4, 6, 11, 15<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2004<br />

31.12.2007<br />

31.12.2007<br />

30.6.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1427<br />

No Vet. No Name of the establishment Shortcomings<br />

155. 24610323 ‘Basco’ s.c. Directive 64/433:<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 5, 12<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

156. 24030206 PPH ‘WARPOL’ Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter II, point 14(f), (g)<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (h)<br />

Annex A, Chapter I, points 4, 8, 11<br />

Annex B, Chapter I, point 2<br />

157. 24040303 PPHU ‘KABANOS’<br />

Anna i Andrzej Ciura<br />

Brzeziny Nowe<br />

158. 24040204 Zakład Przetwórstwa<br />

Mie˛snego ‘UNILANG’<br />

159. 24040205 Zakłady Mie˛sne<br />

‘Aleksandria’<br />

Dariusz Moczarski<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(g)<br />

Annex I, Chapter I, point 4(a), (b), (e)<br />

Annex I, Chapter I, points 9, 11, 12, 13<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (g)<br />

Annex A, Chapter I, points 6, 11, 12, 13,<br />

14, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 9, 12, 13<br />

Annex I, Chapter II, point 14(b), (c), (e), (g),<br />

(h), (i), (l)<br />

Annex I, Chapter III, points 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b),<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g), (h)<br />

Annex A, Chapter I, points 6, 8, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter II, point 14(a), (e)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2006<br />

31.12.2006<br />

31.10.2007<br />

30.4.2006


EN<br />

1428 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

160. 24040211 Przetwórstwo Mie˛sa<br />

Andrzej Kosiński<br />

161. 24040213 Przetwórstwo Mie˛sa i<br />

We˛dlin Mariusz Gawron<br />

162. 24040304 PPHU ‘Zakłady Mie˛sne<br />

Lubliniec’ E.R.J Dra˛z˙ek<br />

163. 24640302 Miłkowska Spółka<br />

Komandytowa<br />

164. 24780304 Warsztat We˛dliniarski<br />

Alfred Moj<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(a), (b), (c)<br />

Annex I, Chapter I, points 7, 8, 11, 12<br />

Annex I, Chapter II, point 14(b), (c), (e), (g),<br />

(h), (i)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 9, 10, 12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(g), (h), (i), (k), (l)<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (e), (g), (h)<br />

Annex A, Chapter I, points 9, 11, 12, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(c), (d), (e)<br />

Annex I, Chapter I, points 8, 9, 11, 12<br />

Annex I, Chapter III, point 15(b), (c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (c), (e), (g),<br />

(h)<br />

Annex A, Chapter I, points 4, 7, 8, 9, 11,<br />

12, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex A, Chapter I, points 11, 12<br />

Annex I, Chapter III, point 15(c)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 11, 15<br />

Date of full<br />

compliance<br />

31.10.2007<br />

30.6.2007<br />

31.12.2007<br />

31.10.2007<br />

31.10.2005


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1429<br />

No Vet. No Name of the establishment Shortcomings<br />

165. 24720304 ‘Wakpol’ Sp. z o.o Directive 77/99:<br />

Annex A, Chapter I, point 1,<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex B, Chapter I, point 2<br />

166. 24690301 PPH ‘Giszowiec’ Sp. z o.o Directive 64/433:<br />

Annex I, Chapter I, point 1(b), (g)<br />

Annex I, Chapter I, points 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b), (c), (e)<br />

Annex I, Chapter I, point 8<br />

167. 24630304 Zakłady Mie˛sne<br />

E. E. Pils´niak<br />

168. 24720306 ZMS Madej — Wróbel<br />

Sp. z o.o<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (c), (f), (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, points 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (c), (d), (f),<br />

(g)<br />

Annex A, Chapter I, points 4, 8, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9, 10,<br />

12, 13<br />

Annex I, Chapter III, point 15(c), (d)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 9,<br />

10, 11, 12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9, 10,<br />

11, 12, 13<br />

Annex I, Chapter III, point 15(a), (b), (c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.10.2007<br />

31.10.2007<br />

31.12.2007


EN<br />

1430 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

169. 24070209 Zakłady Mie˛sne<br />

‘JANDAR’ Sp. z o.o<br />

170. 24110313 Firma Produkcyjno-Handlowa<br />

‘KRETEK’<br />

171. 24120104 Marian Procek – Ubój,<br />

Skup i Sprzedaz˙<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 5, 8, 10, 11, 12<br />

Annex I, Chapter II, point (f), (g), (h)<br />

Annex I, Chapter III, point 15(a), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 14(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 8, 9, 11, 13,<br />

14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 8, 9, 11, 12,<br />

13<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 6, 8, 9, 11,<br />

12, 13, 14, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 10, 11, 12, 13<br />

Annex I, Chapter II, point 14(c), (d), (e), (f),<br />

(h), (i)<br />

Annex I, Chapter III, point 15(d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

172. 24120203 ‘LESZ’ Sp. z o.o Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (g)<br />

Annex I, Chapter I, point 3<br />

Date of full<br />

compliance<br />

30.9.2007<br />

31.12.2006<br />

31.12.2007<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1431<br />

No Vet. No Name of the establishment Shortcomings<br />

173. 24790211 Zakłady Mie˛sne<br />

‘PREZROL’ Sp. z o.o<br />

174. 24730212 Rzez´nictwo-<br />

We˛dliniarstwo<br />

Antoni Woz´niczka<br />

175. 24700301 Zakłady Mie˛sne<br />

Mysłowice ‘Mysław’ Sp. z o.o<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 7, 8, 9, 10,<br />

11, 12, 13<br />

Annex I, Chapter II, point 14(c), (d), (e), (f),<br />

(g), (h), (i), (l)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b), (e)<br />

Annex A, Chapter I, points 4, 5, 6, 8, 9, 11,<br />

12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter III, point 15(c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c)<br />

Annex A, Chapter I, point 15<br />

Directive 64/433:<br />

Annex I, Chapter III, point 15(c), (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (e)<br />

Annex A, Chapter I, points 4, 8, 11, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 9, 11, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, points 1(a), (b), (c), (e),<br />

(g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 8, 11, 12<br />

176. 24670301 Zakład Mie˛sny ‘HAGA’ Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 11, 12<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g), (h)<br />

Annex A, Chapter I, points 5, 11, 15<br />

Date of full<br />

compliance<br />

31.8.2007<br />

30.6.2007<br />

31.12.2006<br />

30.4.2007


EN<br />

1432 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

177. 24160301 Zakład ‘JAF’ II<br />

Z.P. Mie˛snego s.j.<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 11,<br />

15<br />

Annex B, Chapter I, point 2<br />

178. 24160302 ‘NELPOL’ s. c. Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 9,<br />

11, 12, 13, 14, 15<br />

179. 24170201 Zakłady Mie˛sne w<br />

Z˙ywcu Wojciech Dobija<br />

180. 24170202 Zakład Rzez´niczo –<br />

Przetwórczy Jerzy Wolas<br />

181. 24170301 Zakład Przetwórstwa<br />

Mie˛snego B.<br />

Wis´niewska<br />

182. 24170303 Zakład Przetwórstwa<br />

Mie˛snego ‘Błachut’<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(d), (e)<br />

Annex I, Chapter I, points 8, 10, 11, 12<br />

Annex I, Chapter III, point 15(c), (d)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(h)<br />

Annex A, Chapter I, points 7, 11, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (e), (g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter III, point 15(c)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c),<br />

Annex A, Chapter I, points 4, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 8, 11, 12<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f)<br />

Annex A, Chapter I, points 4, 6, 9, 11, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d)<br />

Annex I, Chapter I, points 8, 12<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2007<br />

31.12.2007<br />

30.4.2007<br />

31.3.2007<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1433<br />

No Vet. No Name of the establishment Shortcomings<br />

183. 24170311 Zakład Przetwórstwa<br />

Mie˛snego Sp. Jawna<br />

Voivodship, S´ wie˛tokrzyskie<br />

184. 26040101 Ubojnia Bydła i Trzody –<br />

Ludwik Andrzej Sta˛pór<br />

185. 26040207 Zakład Masarski –<br />

Henryka Zychowicz<br />

186. 26040209 ‘Wir’ Szproch I<br />

Przetwórstwo Mie˛sa SJ.<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(e), (h)<br />

Annex A, Chapter I, points 4, 6, 7, 9, 15<br />

Annex B, Chapter I, point 2<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d)<br />

Annex I, Chapter I, points 8, 12<br />

Annex I, Chapter III, point 15(a), (b)<br />

Annex I, Chapter IV, point 16(a)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 9, 12<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (e)<br />

Annex A, Chapter I, points 4, 12, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(f), (g), (h), (i), (j)<br />

Annex I, Chapter IV, point 16(b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (d), (e)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 9, 10, 11, 12<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (e), (g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5, 12<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2007<br />

31.3.2007<br />

31.3.2007


EN<br />

1434 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

187. 26040307 Wyrób i Sprzedaz˙<br />

Artykułów Mie˛snych –<br />

S. Woz´niak<br />

188. 26040316 PPHU ‘KORREKT’<br />

Wytwórnia We˛dlin<br />

189. 26070201 Zakład Przetwórstwa<br />

Mie˛snego ‘MARKUZ’ –<br />

Marian Kuzka<br />

190. 26080102 ‘ESKULAP’ Zakład<br />

Uboju Trzodyi<br />

Sprzedaz˙ Półtusz<br />

Annex I, Chapter III, point 15(c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(d)<br />

Annex A, Chapter I, points 4, 8, 9, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 9, 12<br />

Annex I, Chapter III, point 15(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (c)<br />

Annex A, Chapter I, points 12, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, points 5, 12<br />

Annex I, Chapter III, point 15(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (e), (h)<br />

Annex A, Chapter I, points 8, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 7, 11<br />

Annex I, Chapter II, point 14(c), (e), (f), (g),<br />

(h), (i), (j)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(g), (h)<br />

Annex A, Chapter I, point 8<br />

Directive 64/433:<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter II, point 14(l)<br />

Annex I, Chapter IV, point 16(b)<br />

191. 26090201 FHPU ‘Tarkowski’ Directive 77/99:<br />

Annex A, Chapter I, points 9, 15<br />

Date of full<br />

compliance<br />

30.11.2007<br />

30.6.2007<br />

30.4.2007<br />

28.2.2007<br />

30.11.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1435<br />

No Vet. No Name of the establishment Shortcomings<br />

192. 26610201 Zakłady Mie˛sne S.A. Kielce Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (e), (g)<br />

Annex I, Chapter I, point 3,<br />

Annex I, Chapter I, point 4(b), (e)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (e)<br />

Annex A, Chapter I, points 5, 8, 11, 15<br />

193. 26610303 Przetwórnia Mie˛sa –<br />

Antonii Kamiński<br />

Voivodship, Warmińsko — Mazurskie<br />

194. 28010202 Zakład Uboju i<br />

Przetwórstwa Mie˛snego<br />

s.c. Helena Rapa —<br />

Marek Jasiński<br />

195. 28010201 Zakłady Mie˛sne Pek-Bart<br />

Sp. z o.o<br />

196. 28090201 Zakład Uboju i<br />

Przetwórstwa Mie˛sa i<br />

We˛dlin, Krzysztof<br />

Brzeziński<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (g)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter III, point 15(c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (c), (e)<br />

Annex A, Chapter I, points 4, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 5, 12<br />

Annex I, Chapter II, point 14(a), (c), (d), (j),<br />

(l)<br />

Annex I, Chapter III, point 15(a)<br />

Annex I, Chapter IV, point 17(a)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 5, 11, 12<br />

Annex I, Chapter II, point 14(a), (c), (d), (j),<br />

(l)<br />

Annex I, Chapter III, point 15(a)<br />

Annex I, Chapter IV, point 17(a)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 4(c), (d), (e)<br />

Annex I, Chapter I, points 7, 9, 10, 11, 12,<br />

13<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2007<br />

31.12.2007<br />

31.12.2007<br />

31.12.2007


EN<br />

1436 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship, Wielkopolskie<br />

197. 30020201 Gminna Spółdzielnia<br />

‘SCH’ Masarnia Osuch<br />

Annex I, Chapter II, point 14(b), (c), (e), (g),<br />

(h), (i), (j), (k), (l)<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(c), (e), (h)<br />

Annex A, Chapter I, points 4, 7, 8, 11, 12,<br />

13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(c), (d), (e)<br />

Annex I, Chapter I, point 8, 9, 10, 11<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (h), (l)<br />

Annex I, Chapter III, point 15(b), (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (e)<br />

Annex A, Chapter I, points 4, 7, 8, 11, 12,<br />

15<br />

198. 30030102 PPHU ‘Jas´likowscy’ sc Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(a), (b), (c)<br />

Annex I, Chapter I, points 8, 10<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (g), (i), (l)<br />

Annex I, Chapter III, point 15(c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

199. 30030106 ‘JUTAR’ sc, Łagiewniki<br />

Kos´cielne 3<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 7, 8, 9, 10,<br />

11, 12, 13<br />

Annex I, Chapter II, point 14(b), (c), (f), (g),<br />

(h), (i), (j), (k), (l)<br />

Date of full<br />

compliance<br />

30.11.2007<br />

31.12.2007<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1437<br />

No Vet. No Name of the establishment Shortcomings<br />

200. 30040207 PPHU ‘MAR-POL’<br />

Marek Pazola<br />

201. 30040222 Rzez´nictwo Matuszewski i<br />

G. Kiel<br />

202. 30050214 ‘Rzez´nia’<br />

Urzula Heinrich<br />

Annex I, Chapter III, point 15(d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d)<br />

Annex I, Chapter I, points 5, 9, 11, 12, 13<br />

Annex I, Chapter II, point 14(b), (f), (i), (l)<br />

Annex I, Chapter III, point 15(a), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(b), (c), (f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 8, 11, 12<br />

Annex I, Chapter II, point 14(b), (c), (h), (k),<br />

(l)<br />

Annex I, Chapter III, point 15(b), (c)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 8, 12, 13<br />

Annex I, Chapter II, point 14(k)<br />

Annex I, Chapter III, point 15(d)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 7, 8, 9, 13,<br />

14, 15<br />

Annex B, Chapter I, point 2<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2006<br />

30.11.2004


EN<br />

1438 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

203. 30070102 PHU ‘JUREX’<br />

K. Nowak<br />

204. 30070203 PPH ‘POLSKIE MIE˛SO’,<br />

Kra˛z˙yński s.j.<br />

205. 30070209 PPH ‘BARTEX’ Sp. j.<br />

ZPChr R. G. Brońs´<br />

206. 30610201 Zakład Rzez´niczo<br />

We˛dliniarski,<br />

P. Łyszczak<br />

207. 30080213 Zakłady Mie˛sne w<br />

Ke˛pnie S.A.<br />

208. 30090101 Przedsie˛biorstwo<br />

Produkcyjno<br />

Usługowo<br />

Handlowe<br />

GALW-MIE˛S<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 5, 9, 11, 12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(f), (g), (h), (i), (l)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (e)<br />

Annex A, Chapter I, points 4, 11, 14<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(b), (g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11, 12, 13<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b), (c)<br />

Annex A, Chapter I, points 4, 11, 13, 14, 15<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 11, 13, 14<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9, 10,<br />

11, 12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(f), (g), (h), (i), (j), (k)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 9,<br />

10, 11, 12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (c), (e)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.7.2007<br />

31.12.2007<br />

31.5.2006<br />

31.12.2006<br />

31.12.2005


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1439<br />

No Vet. No Name of the establishment Shortcomings<br />

209. 30090103 Firma Handlowo<br />

Usługowa – Andrzej<br />

Mejsner<br />

210. 30090105 Ubojnia Zwierza˛t<br />

Meisner Marzena<br />

211. 30090301 Masarnia KWIATEK<br />

Z. Kwiatek<br />

212. 30090306 PPHU CARNIS<br />

Bronisław Rowecki<br />

213. 30110103 PPHU S.Prałat, Bogdan<br />

Dolczewski<br />

Annex I, Chapter I, points 8, 11, 12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (h), (i), (j)<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c), (d), (e)<br />

Annex I, Chapter I, points 8, 9, 10, 11,<br />

12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (g), (h), (i), (j), (k), (l)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter II, point 14(a), (c), (e), (h),<br />

(k)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (d), (e)<br />

Annex A, Chapter I, point 6<br />

Directive 64/433:<br />

Annex I, Chapter III, point 15(c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (c), (e), (f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 8, 12, 13<br />

Annex I, Chapter II, point 14(c), (e)<br />

214. 30120305 PPH P. Płonka Directive 64/433:<br />

Annex I, Chapter I, point 1(c)<br />

Annex I, Chapter I, point 4(b), (c), (d), (e)<br />

Annex I, Chapter I, points 7, 9, 12, 13<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

31.12.2006<br />

31.3.2007<br />

31.12.2007<br />

30.9.2005<br />

31.12.2006


EN<br />

1440 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b), (h)<br />

Annex A, Chapter I, points 4, 7, 8, 12, 13,<br />

14, 15<br />

215. 30120317 PW Domak Dariusz Rozum Directive 64/433:<br />

Annex I, Chapter III, point 15(a), (b), (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 11,<br />

13, 14, 15<br />

216. 30120307 ZPM ‘Janex’ Directive 64/433:<br />

Annex I, Chapter III, point 15(a), (b), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 9,<br />

11, 12, 13, 14, 15<br />

217. 30140205 Rzez´nictwo<br />

We˛dliniarstwo Tomasz Lubik<br />

218. 30180202 STEK-POL<br />

Przetwórstwo Mie˛sa<br />

Kazimierz i Jacek<br />

Stempniewicz<br />

Directive 64/433:<br />

Annex I, Chapter II, point 14(a), (b) (c), (e),<br />

(f), (g), (h), (i), (j), (l)<br />

Annex I, Chapter III, point 15(a), (b)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 8, 9, 10, 11,<br />

12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (g), (h), (i), (j), (k), (l)<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, points 4, 8, 9, 11, 12,<br />

13, 14, 15<br />

Annex B, Chapter I, point 2<br />

Date of full<br />

compliance<br />

31.12.2005<br />

31.12.2007<br />

31.12.2007<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1441<br />

No Vet. No Name of the establishment Shortcomings<br />

219. 30180204 ‘SZWAGROS’<br />

Masarstwo-We˛dliniarstwo<br />

Sp. z o.o<br />

220. 30180205 Zakład Masarski<br />

Tadeusz Krawiec<br />

221. 30180304 Firma Produkcyjno<br />

Handlowa Paweł Łuczak<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 7, 8, 9, 10,<br />

11, 12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (g), (h), (i), (j), (k), (l)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 6, 7, 8, 9, 11,<br />

12, 14<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 9, 10, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (g), (h), (i), (j), (k), (l)<br />

Annex I, Chapter III, point 15(a)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, points 4, 5, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 6, 7, 8, 9, 11,<br />

12, 13, 14, 15<br />

222. 30170207 ZPM Roman Stendera Directive 64/433:<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Date of full<br />

compliance<br />

31.12.2006<br />

30.9.2007<br />

31.10.2007<br />

31.12.2007


EN<br />

1442 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

223. 30200207 Ubój i Masarnia T. E.<br />

Kowalscy sp. j<br />

224. 30200101 Ubój Zwierza˛t Ptak,<br />

Michalak sp.j.<br />

225. 30210307 ALBAN Sp. z o.o<br />

Jerzy Kniat<br />

226. 30220201 Ubojnia Masarnia<br />

‘Folmas’ Sp. z o.o<br />

<strong>227</strong>. 30220202 Zakład Rzez´niczo<br />

We˛dliniarski Tadeusz<br />

Szczepaniak<br />

228. 30220104 Ubojnia zwierza˛t<br />

Rzez´nych B. W.<br />

Grzelewscy<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g)<br />

Annex A, Chapter I, points 4, 8, 9, 13, 14,<br />

15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e), (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9,<br />

10, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (g), (h), (i), (j), (k), (l)<br />

Annex I, Chapter III, point 15(a), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (d), (e), (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a), (b), (c), (e),<br />

Annex I, Chapter I, points 5, 8, 9, 10, 11,<br />

12<br />

Annex I, Chapter II, point 14(b), (c), (d), (g),<br />

(h), (i), (l)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (d), (e)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (f), (g)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(c), (e), (f)<br />

Annex A, Chapter I, points 11, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, points 9, 11, 12, 13<br />

Annex I, Chapter II, point 14(b), (h), (l)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, points 11, 12, 13, 14,<br />

15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(d)<br />

Annex I, Chapter I, points 6, 7, 8, 12<br />

Annex I, Chapter II, point 14(a), (e), (g), (h)<br />

Date of full<br />

compliance<br />

30.6.2007<br />

30.6.2007<br />

31.12.2007<br />

31.12.2006<br />

30.4.2004<br />

30.4.2005


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1443<br />

No Vet. No Name of the establishment Shortcomings<br />

229. 30220302 ‘Matro’ Masarnia<br />

T.R.M.A.<br />

Pietruszkas s.j.<br />

230. 30220207 ZPM sp.j. G.E.J.<br />

Dworeccy<br />

231. 30240202 ‘KARWEX’ sc Zakład<br />

Masarski<br />

232. 30240205 Zakład Masarski sc<br />

Psarskie<br />

233. 30260102 Punkt Uboju RSP<br />

Mszczyczyn<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, points 9, 10<br />

Annex I, Chapter III, point 15(b), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 9,<br />

10, 11, 12, 13, 14, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, point 11, 12, 13<br />

Annex I, Chapter II, point 14(c), (f), (h), (l)<br />

Annex I, Chapter III, point 15(a), (c), (d)<br />

Annex I, Chapter IV, point 16(a)<br />

Annex I, Chapter IV, point 17(a)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(c), (e)<br />

Annex A, Chapter I, points 4, 11, 15<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f)<br />

Annex A, Chapter I, points 6, 8, 9, 11, 15<br />

Directive 64/433:<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(g), (h), (i), (j)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 6, 7, 8, 9, 11,<br />

12, 13, 14<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter II, point 14(i), (j)<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2007<br />

30.1.2007<br />

31.12.2007<br />

30.6.2006


EN<br />

1444 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

234. 30260202 Rzez´nictwo<br />

Wedliniarstwo sc<br />

Urszula i Wiesław<br />

Ciachowscy<br />

235. 30250102 Rzez´nictwo M. i M.<br />

We˛dliniarstwo<br />

Matuszak<br />

236. 30270206 PPH PEKTUR sj.<br />

Jerzy Pacholski,<br />

Marek Domeński<br />

237. 30270307 Zakład Mie˛sny<br />

‘SMOLIŃSKI’ Zbigniew<br />

Smoliński<br />

238. 30270308 Zakład Mie˛sny MAS<br />

POL, Tomasz Jacaszek<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter II, point 14(b), (h)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(d), (e)<br />

Annex A, Chapter I, points 8, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(b), (c), (e)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 7, 12<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c), (d)<br />

Annex I, Chapter I, points 5, 8, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(f), (g), (h), (j), (k)<br />

Annex I, Chapter III, point 15(b), (d)<br />

Annex I, Chapter IV, point 16(a), (b),<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (c), (d), (e),<br />

(g), (h)<br />

Annex A, Chapter I, points 4, 6, 8, 9, 11,<br />

14, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(c), (d)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 4, 7, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Date of full<br />

compliance<br />

31.10.2007<br />

30.11.2007<br />

31.12.2007<br />

31.12.2004<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1445<br />

No Vet. No Name of the establishment Shortcomings<br />

239. 30280102 PHU ROMEX Graz˙yna<br />

Pachela, Ubojnia Bydła<br />

240. 30280205 Masarnia Ubojnia<br />

BRONEX Łukaszewska i<br />

Królczyk Sp. j.<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9, 10,<br />

11, 12, 13<br />

Annex I, Chapter II, point 14(f)<br />

Annex I, Chapter III, point 15(a), (b)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 5, 6, 7, 8, 9,<br />

10, 11, 12, 13, 14, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (e), (g)<br />

Annex I, Chapter I, point 4(a), (b), (c),<br />

Annex I, Chapter I, points 5, 8, 9, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (g), (h), (i), (j), (k)<br />

Annex I, Chapter IV, point 16(b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 11, 12, 13<br />

Annex I, Chapter II, point 14(c), (d), (e), (g),<br />

(h)<br />

Annex I, Chapter III, point 15(b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 5, 6, 7, 8, 9, 11,<br />

14, 15<br />

241. 30280101 Rzez´nia Adam Kotecki Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (f)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (c), (e)<br />

Annex I, Chapter I, points 5, 6, 7, 8, 9, 11,<br />

12<br />

Annex I, Chapter II, point 14(c), (d), (e), (l)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a)<br />

Date of full<br />

compliance<br />

30.1.2006<br />

30.4.2007<br />

31.12.2007


EN<br />

1446 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

242. 30280301 PPH ROMEX, Graz˙yna<br />

Pachela, Masarnia<br />

243. 30290201 Rzez´nictwo Kujawa,<br />

Maik s.j.<br />

244. 30300108 Rzez´nictwo Janusz i<br />

Marek Goła˛b<br />

245. 30300114 Skup-Ubój Zwierza˛t<br />

Sprzedaz˙<br />

246. 30300112 Ubój Trzody Mariusz<br />

Marciniak<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (e), (g)<br />

Annex I, Chapter I, point 2(a), (b), (c), (e)<br />

Annex I, Chapter I, points 8, 9, 11, 12<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex A, Chapter I, points 4, 6, 9, 11, 12,<br />

14, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 8, 9, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (h), (k), (l)<br />

Annex I, Chapter III, point 15(b), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 8, 9, 11, 12,<br />

13<br />

Annex I, Chapter II, point 14(b), (c), (d), (f),<br />

(h), (i), (j), (k), (l)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 8, 9, 11, 12,<br />

13<br />

Annex I, Chapter II, point 14(b), (c), (d), (f),<br />

(h), (i), (j), (k), (l)<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Date of full<br />

compliance<br />

30.1.2006<br />

31.12.2006<br />

30.6.2006<br />

30.6.2006<br />

30.6.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1447<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship, Zachodniopomorskie<br />

247. 32030202 Rzez´nictwo i<br />

We˛dliniarstwo<br />

Janusz Niedz´wiedz´<br />

248. 32050201 Z P Ms Grabowscy Izabela<br />

Zbigniew<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 8, 9, 11, 12,<br />

13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (h), (i), (j), (k), (l)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 11, 12<br />

Annex I, Chapter II, point 14(a), (b), (c), (e),<br />

(f), (h), (i), (j), (k), (l)<br />

Annex I, Chapter III, point 15(a), (b), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f)<br />

Annex A, Chapter I, points 7, 9, 11, 15<br />

Annex B, Chapter I, point 2<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter IV, point 17(a)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d)<br />

Directive 71/118:<br />

Annex I, Chapter IV, point 17(a)<br />

249. 32050203 Masarnia Wiejska ‘Dyjak’ Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, point 15<br />

250. 32050302 ZPM ‘Elda’ s.c<br />

Dankiewicz &<br />

Dankiewicz<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, points 8, 12<br />

Annex I, Chapter III, point 15(c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e), (g)<br />

Annex A, Chapter I, points 9, 15<br />

251. 32070201 ‘Rol-Banc’ Sp. z o.o Directive 64/433:<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter II, point 14(h)<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2006<br />

30.4.2005<br />

31.12.2004<br />

30.9.2007


EN<br />

1448 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

252. 32070301 ‘Koyan’ Spółka Jawna<br />

Konrad Ma˛dry & Jan Wójcik<br />

253. 32070103 F.U.H. ‘Gryf-Meat’<br />

s.j. Rzez´nia Janusz<br />

Młynarski, Zbigniew<br />

Jasnowski<br />

254. 32080201 Rzez´nictwo<br />

We˛dliniarstwo<br />

Rybarkiewicz<br />

Mirosław<br />

255. 32110301 ‘Byk’ spółka jawna<br />

Jacek Malinowski &<br />

Dariusz Osiniak<br />

256. 32140207 Spółdzielcza Agrofirma<br />

Witkowo<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 8, 9, 11, 15<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(b), (d), (e)<br />

Annex I, Chapter I, points 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (e)<br />

Annex A, Chapter I, points 7, 8, 11, 14, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter II, point 14(a), (f)<br />

Annex I, Chapter IV, point 16(a)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e), (f), (g)<br />

Annex I, Chapter I, points 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, points 4, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5, 11, 12<br />

Annex I, Chapter III, point 15(a), (b)<br />

Annex I, Chapter IV, point 16(a)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c), (e), (g)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, points 8, 12<br />

Annex I, Chapter II, point 14(c), (d)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (d), (e)<br />

Annex A, Chapter I, points 6, 8, 9, 15<br />

Date of full<br />

compliance<br />

31.10.2006<br />

28.2.2006<br />

31.10.2005<br />

31.12.2004<br />

30.4.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1449<br />

No Vet. No Name of the establishment Shortcomings<br />

257. 32150101 Przedsie˛biorstwo<br />

Produkcji Zwierze˛cej<br />

‘Przybkowo’ Sp. z o.o<br />

258. 32160202 ‘Fermapol’ Sp. z o.o<br />

Rzez´nia w Smardzku<br />

259. 32180302 Zakład Przetwórstwa<br />

Mie˛snego i Dodatków<br />

Masarskich s.c<br />

B. Niedz´wiedzki<br />

H. Niedz´wiedzka<br />

260. 32630301 Masarnia ‘Społem’ PSS<br />

Sp. z o.o<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (g)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter II, point 14(h)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 9, 10, 11, 12<br />

Annex I, Chapter II, point 14(b), (g), (h), (j)<br />

Directive 77/99:<br />

Annex A, Chapter I, points 4, 11, 12, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter III, point 15(a)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 4, 11, 15<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(g)<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 11, 12, 13<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 94/65:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, points 4, 8, 11, 13, 14,<br />

15<br />

List of white meat establishments in transition<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship, Dolnos´la˛skie<br />

1. 02090601 Animex Południe w<br />

De˛bicy, Oddział w<br />

Prochowicach,<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (e)<br />

Annex A, Chapter I, points 6, 15<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2007<br />

31.12.2004<br />

31.12.2007<br />

Date of full<br />

compliance<br />

28.2.2007


EN<br />

1450 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

2. 02190518 Rolpek – 2 Sp. z o.o Zakład<br />

Produkcji Chronionej<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex A, Chapter I, points 4, 8, 11, 13, 14,<br />

15<br />

Annex B, Chapter I, point 2<br />

3. 02190623 ‘Mirjan’ Sp. z o.o M.J. Olendzcy Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex A, Chapter I, point 5<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (g)<br />

Annex A, Chapter I, point 3<br />

Annex A, Chapter I, point 4(b)<br />

4. 02640501 Wrocławskie Zakłady<br />

Drobiarskie S.A. w<br />

upadłos´ci<br />

Voivodship, Lubuskie<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g), (h)<br />

Annex A, Chapter I, points 5, 6, 7, 8, 9, 11,<br />

13, 14, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 7, 8, 11, 12,<br />

13<br />

5. 08010505 ‘Ekpols’ Sp. z o.o Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (g)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, Point 4(c)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter II, point 14(a), (b)<br />

Annex I, Chapter III, point 15(b), (c)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

6. 08010504 PHPU ‘DROSAN’ Sp. z o.o Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (e)<br />

Annex I, Chapter I, points 5, 12<br />

Annex I, Chapter II, point 14(b), 1(e), (g)<br />

Annex I, Chapter III, point 15(a), (c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a)<br />

7. 08030601 PPHU ‘W-D’ Sp. z o.o Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (f), (g)<br />

Date of full<br />

compliance<br />

31.12.2005<br />

31.12.2007<br />

31.12.2007<br />

31.12.2005<br />

31.12.2006<br />

31.10.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1451<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex A, Chapter I, points 5, 6, 8, 9, 10,<br />

11, 12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

8. 08040501 ‘STUDRÓB’ Sp. z o.o Directive 71/118:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, points 8, 11<br />

Annex I, Chapter II, point 14(e), (g)<br />

Annex I, Chapter III, point 15(c)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Voivodship, Łódzkie<br />

9. 10060502 Ubojnia Drobiu<br />

Jerzy Piórkowski<br />

10. 10160501 TZD ‘Roldrob’ S.A.<br />

97-200 Tomaszów Maz.<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 9, 10, 11, 12, 13<br />

Annex I, Chapter II, point 14(a), (d), (e), (g)<br />

Annex I, Chapter IV, point 16(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (b), (c), (d)<br />

Annex A, Chapter I, point 8<br />

11. 10080801 Rabbits Slaughterhouse Directive 71/118:<br />

Annex I, Chapter I, point 4(d), (e)<br />

Annex I, Chapter I, points 8, 11, 12, 13<br />

Annex I, Chapter III, point 15(a), (c)<br />

12. 10010401 Przedsie˛biorstwo<br />

Drobiarskie M&R Sp.J.<br />

Voivodship, Małopolskie<br />

13. 12030620 Hurtownia Drobiu<br />

‘KOKO’<br />

Jolanta Kozyra<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5, 11, 12<br />

Annex I, Chapter II, point 14(g)<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 9, 11, 12<br />

Directive 71/118:<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 9, 11, 12<br />

Annex I, Chapter III, point 15(c)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Date of full<br />

compliance<br />

31.10.2007<br />

30.4.2007<br />

31.12.2007<br />

30.4.2006<br />

31.12.2007<br />

31.12.2007


EN<br />

1452 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

14. 12620601 P.P.H. DROBEKSAN<br />

Rozbiór Drobiu,<br />

Artur Pore˛ba<br />

15. 12160501 ‘DROBTAR’ W. Kawalec<br />

J. Kawalec, M. Kawalec, S.J.<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, points 9, 11<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 9<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 5, 8, 9, 11, 12<br />

Annex I, Chapter II, point 14(d), (e), (g)<br />

Annex I, Chapter III, point 15(c)<br />

Annex I, Chapter IV, point 17(b)<br />

16. 12180502 Z.M. ‘BRADO-2’ S.A. Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 5, 11, 12<br />

Annex I, Chapter II, point 14(a), (g)<br />

Annex I, Chapter III, point 15(a), (b)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

17. 12180503 ‘KO – BO’ S.C<br />

Bartosz Kot,<br />

Stanisław Wne˛cek<br />

18. 12190601 PPHU ‘JÓZEF’ s.c.<br />

M. Słowik, A. Matusik-Słowik,<br />

J. Słowik<br />

19. 12020601 PPHU ‘IMEX’<br />

G. Marek i S. Sala S.J.<br />

Voivodship, Opolskie<br />

20. 16070501 Bielickie Zakłady<br />

Drobiarskie Sp. z o.o<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (f)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(d)<br />

Annex I, Chapter I, points 9, 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b), (g)<br />

Annex A, Chapter I, points 4, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, point 4(c), (d), (e)<br />

Annex I, Chapter I, points 9, 11, 12, 13<br />

Annex I, Chapter II, point 14(e)<br />

Directive 71/118:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11, 12<br />

Date of full<br />

compliance<br />

31.3.2007<br />

30.4.2005<br />

31.12.2007<br />

31.12.2007<br />

31.10.2004<br />

31.10.2005<br />

30.9.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1453<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship, Mazowieckie<br />

21. 14620501 Płockie Zakłady<br />

Drobiarskie<br />

‘SADROB’ S.A.<br />

22. 14190601 P. P-H. ‘Doldrób’<br />

Sp. J.<br />

23. 14190501 Ławniczak Sp. z o.o<br />

Ubojnia drobiu<br />

‘Ekol-Drob’<br />

24. 14130502 Przedsie˛biorstwo Uboju i<br />

Przetwórstwa Drobiu<br />

‘Ilczak’ Sp. z o.o<br />

25. 14370501 Przedsie˛biorstwo Rolno-<br />

Spoz˙ywcze ‘DORPOL’<br />

M.Dobies i S-ka S. J.<br />

Directive 77/99:<br />

Annex A, Chapter I, points 11, 12, 15<br />

Annex B, Chapter I, point 2<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (e)<br />

Annex A, Chapter I, points 4, 9, 12, 13, 14,<br />

15<br />

Annex B, Chapter I, point 2<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (c), (e), (g)<br />

Annex I, Chapter I, point 4(b), (c), (e)<br />

Annex I, Chapter I, points 5, 8, 9, 10, 12,<br />

13<br />

Directive 71/118:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter II, point 14(a), (e), (g)<br />

Annex I, Chapter IV, point 16(b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, points 11, 12, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, point 12<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(c), (e)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 7, 8, 11, 12<br />

Annex I, Chapter II, 14(b), (d), (e), (g)<br />

Annex I, Chapter II, point 15(a), (b), (c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

26. 14250605 ‘ALBO’ Sp. z o.o Directive 71/118:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(e)<br />

Annex I, Chapter I, points 7, 9, 10, 11<br />

27. 14250602 Zakład Hurtu i Rozbioru<br />

Drobiu<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (e)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, points 9, 11<br />

Annex I, Chapter IV, point 17(b)<br />

Date of full<br />

compliance<br />

30.6.2007<br />

31.3.2007<br />

31.12.2006<br />

30.11.2007<br />

31.10.2006<br />

31.12.2005<br />

31.12.2005


EN<br />

1454 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

28. 14250604 Krzyz˙anowscy Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(e)<br />

Annex A, Chapter I, points 6, 7, 11, 12<br />

29. 14250606 POLMAR S.C. E. M. M.<br />

Hajtowicz<br />

Voivodship, Podkarpackie<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(b), (c), (d), (e),<br />

(f), (g)<br />

Annex A, Chapter I, points 4, 6, 7, 8, 9, 11,<br />

12, 13, 14, 15<br />

Annex B, Chapter I, point 2<br />

30. 18030501 ‘Animex-Południe’ Sp. z o.o Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (c), (e)<br />

Annex A, Chapter I, point 15<br />

31. 18630501 Jedynka Spółka z o.o.<br />

Zakład Produkcyjny<br />

Voivodship, Podlaskie<br />

32. 20020601 Zakła˛d spoz˙ywczy<br />

‘KABO’ S.J. jawna<br />

Voivodship, Pomorskie<br />

33. 22150501 Przedsie˛biorstwo<br />

Produkcyjno –<br />

Handlowe<br />

Ubojnia Drobiu<br />

‘LEMADRÓB’<br />

mgr inz˙. L. I M.<br />

Cymann<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (d), (e)<br />

Annex A, Chapter I, points 4, 5, 8, 11, 14,<br />

15<br />

Annex B, Chapter I, point 2<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (c), (e)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 5, 10, 11, 12<br />

Annex I, Chapter II, point 14(b), (d), (e)<br />

Annex I, Chapter III, point 15(a)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(a), (d), (e)<br />

Annex A, Chapter I, points 4, 6, 7, 11, 12,<br />

15<br />

Directive 71/118:<br />

Annex I, Chapter I, point 4(e)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter II, point 14(g)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

30.4.2006<br />

31.3.2005<br />

30.6.2007<br />

30.6.2006<br />

31.12.2005


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1455<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship, S´ la˛skie<br />

34. 24610602 Szerwal 2000 Sp. z o.o Directive 71/118:<br />

Annex I, Chapter I, point 1(a)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 9, 11, 12<br />

35. 24020605 Chłodnie Składowe<br />

‘Delico’ S.C.<br />

36. 24640401 Gospodarstwo Drobiarskie<br />

‘BROJKO’<br />

37. 24640402 Skup i Ubój Drobiu Adam<br />

Korbela<br />

Voivodship, S´ wie˛tokrzyskie<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (e)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, points 9, 11, 12<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, points 8, 12<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(b), (c), (e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, points 8, 9, 11, 12<br />

Annex I, Chapter II, point 14(a), (g)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

38. 26040501 PPH ‘KIELDRÓB’ S.c. Directive 77/99:<br />

Annex A, Chapter I, points 4, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, points (e), 11, 12<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter II, point 14(g)<br />

39. 26040502 Zakład Produkcyjno –<br />

Handlowy Stanisław Ste˛pień<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (e)<br />

Annex A, Chapter I, points 6, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(g)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 5, 12<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Date of full<br />

compliance<br />

30.4.2007<br />

31.12.2007<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006<br />

30.6.2005


EN<br />

1456 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

40. 26100401 ‘KULJASZ’ S.j. J.W.Sz. Kuliński Directive 71/118:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter IV, points 11, 12<br />

Annex I, Chapter II, point 14(g)<br />

41. 26100501 ‘MARLEJ’ Sp. z o.o<br />

Zakład Uboju i<br />

Przetwórstwa<br />

Drobiowego<br />

Voivodship, Wielkopolskie<br />

42. 30010401 Ubojnia Drobiu<br />

Spółdzielnia ‘ADOROL’<br />

43. 30050502 Ubojnia Drobiu – Leszek i<br />

Jerzy Smolarek<br />

44. 30050503 ‘IKO’ Kompania<br />

Drobiarska, Zakład<br />

Drobiarski Sp. z o.o<br />

45. 30090401 Ubojnia Drobiu – Marcin<br />

Fra˛tczak<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(g)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 11, 12<br />

Annex I, Chapter II, point 14(g)<br />

Annex I, Chapter III, point 15(c)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(c), (e), (f)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(b), (c)<br />

Annex I, Chapter I, points 8, 11<br />

Annex I, Chapter II, point 14(d), (g)<br />

Annex I, Chapter III, point 15(b)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (f),<br />

(g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(b), (c), (e),<br />

Annex I, Chapter I, points 5, 8, 9, 11, 12,<br />

13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (g)<br />

Annex I, Chapter III, point 15(a), (b), (c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (g)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter I, point 12<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (e), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 9, 10, 12, 13<br />

Annex I, Chapter II, point 14(a), (b), (e)<br />

Annex I, Chapter III, point 15(a), (b)<br />

Date of full<br />

compliance<br />

31.10.2007<br />

31.10.2006<br />

31.12.2007<br />

31.12.2004<br />

28.2.2005<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1457<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(b)<br />

46. 30170401 PPHEI AWRA Sp. z o.o Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter IV, point 4(c), (e)<br />

Annex I, Chapter I, points 8, 9, 11, 12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), 1(d),<br />

(e), (g)<br />

Annex I, Chapter III, point 15(b)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

47. 30180401 ‘DROMICO’ Sp. J. Ubój i<br />

Handel Drobiem E.i Ł.<br />

Je˛drzejak Dera<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 2(a), (b)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (d), (e)<br />

Annex I, Chapter I, points 5, 7, 8, 9, 10, 11,<br />

12, 13<br />

Annex I, Chapter II, point 14(a), (b), (c), (d),<br />

(e), (f), (g)<br />

Annex I, Chapter III, point 15(a), (b), (c)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

48. 30180402 Ubojnia Drobiu Grzegorz Tuz Directive 71/118:<br />

Annex I, Chapter I, point 1(a), (b), (c), (d), (e),<br />

(f), (g)<br />

Annex I, Chapter I, point 3<br />

Annex I, Chapter I, point 4(a), (b), (c), (e)<br />

Annex I, Chapter I, points 5, 8, 9, 10, 11<br />

Annex I, Chapter II, point 14(d)<br />

Annex I, Chapter III, point 15(c)<br />

Annex I, Chapter IV, point 16(b)<br />

Annex I, Chapter IV, point 17(a), (b)<br />

49. 30220501 PPH Ubój i Przetwórstwo<br />

Indyka Słupia Kapitulna 86<br />

50. 30260401 Ubojnia Drobiu w<br />

Niesłabinie RSP Niesłabin<br />

– Zbrudzewo<br />

Directive 64/433:<br />

Annex I, Chapter I, points 11, 12<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b)<br />

Annex A, Chapter I, points 11, 15<br />

Directive 71/118:<br />

Annex I, Chapter I, point 12<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(b), (e), (g)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

30.6.2007<br />

30.9.2007<br />

31.12.2004<br />

30.6.2007


EN<br />

1458 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

51. 30280501 Zakład Wielobranz˙owy<br />

‘STENDRÓB’<br />

Voivodship, Zachodniopomorskie<br />

52. 32050501 Zakład Drobiarski<br />

‘Kardrob’<br />

Krystyna Skierska<br />

53. 32140502 Spółdzielcza Agrofirma<br />

Witkowo<br />

Annex I, Chapter I, points 5, 12<br />

Annex I, Chapter IV, point 16(a)<br />

Annex I, Chapter IV, point 17(b)<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, points 8, 12<br />

Annex I, Chapter II, point 14(d)<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(e)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter IV, point 17(a)<br />

Directive 71/118:<br />

Annex I, Chapter I, point 1(e), (g)<br />

Annex I, Chapter I, point 4(b)<br />

Annex I, Chapter II, point 14(a), (e)<br />

List of red meat low capacity establishments in transition<br />

No Name and address of the establishment Shortcomings<br />

Voivodship, Kujawsko-Pomorskie<br />

1. Zakład Pracy Chronionej<br />

‘Pałuki’ spółka jawna,<br />

Malice 6, 89-240 Kcynia<br />

Voivodship, Lubuskie<br />

2. ‘Nordis’; Chłodnie Polskie<br />

Sp. z o.o Dział Produkcji Mroz˙onek<br />

ul. Zimna 1(a), 65-707 Zielona Góra<br />

Voivodship, Małopolskie<br />

3. ‘Lewil- Iglokrak’ Sp. z o.o, ul. Półłanki 78,<br />

30-740 Kraków<br />

4. FHU ‘Pieroz˙ki-smakoszki’<br />

ul. Parkowa 15, 30-014 Kraków<br />

Directive 77/99:<br />

Annex A, Chapter I, point 1<br />

Annex A, Chapter I, point 2(c)<br />

Annex A, Chapter I, points 4, 9, 11, 13, 14,<br />

15<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (e)<br />

Annex A, Chapter I, points 12, 15<br />

Annex B, Chapter I, point 2<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b), (c), (d), (e)<br />

Annex A, Chapter I, points 7, 12, 15<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b), (c), (h)<br />

Annex A, Chapter I, points 7, 8<br />

Date of full<br />

compliance<br />

30.6.2005<br />

31.12.2005<br />

30.4.2007<br />

Date of full<br />

compliance<br />

30.11.2007<br />

30.11.2007<br />

31.12.2006<br />

30.9.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1459<br />

No Name and address of the establishment Shortcomings<br />

Voivodship, Opolskie<br />

5. Zakład Przetwórstwa Mie˛sa<br />

w Paczkowie PPHU<br />

‘Kalmar’ spółka jawna E.A.M. Kaleta.;<br />

Szczodrowice 65; 57-140 Biały Kos´ciół;<br />

ul. AK 40, 48-370 Paczków<br />

Voivodship, Podkarpackie<br />

6. Zakład Piekarniczo-Cukierniczo-Garmaz˙eryjny<br />

‘Dul’ Sp. z o.o,<br />

Rze˛dzianowice 92, 39-300 Mielec<br />

Voivodship, Pomorskie<br />

7. PPHU ‘Elbro’ Furmanek spółka jawna;<br />

ul. Kos´cielna 6, 76-032 Mielno, oddział/<br />

Siemianice,<br />

ul. Polna 1, 76-200 Słupsk<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (d), (g)<br />

Annex A, Chapter I, points 9, 11, 15<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(g)<br />

Annex A, Chapter I, points 11, 13, 15<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (c), (d), (g),<br />

(h)<br />

Annex A, Chapter I, points 4, 5, 15<br />

Annex B, Chapter I, point 2<br />

List of mixed meat low capacity establishments in transition<br />

No Name and address of the establishment Shortcomings<br />

Voivodship, Małopolskie<br />

1. Z.P.G. Zakład Przetwórstwa<br />

Garmaz˙eryjnego ‘Bono’;<br />

ul. Beskidzka 22, 30-622 Kraków<br />

Voivodship, Podkarpackie<br />

2. ‘Migaba’ Sp. zo.o, Sadkowa Góra 12,<br />

39-305 Borowa<br />

Voivodship, Wielkopolskie<br />

3. ‘Rudopal’ Sp. z o.o<br />

Rudniki 109, 64-330 Opalenica<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(c), (e)<br />

Annex A, Chapter I, point 11<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(b), (c), (e), (g),<br />

(h)<br />

Annex A, Chapter I, points 8, 11, 15<br />

Directive 77/99:<br />

Annex A, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (h)<br />

Annex A, Chapter I, point 4<br />

Date of full<br />

compliance<br />

31.5.2005<br />

31.12.2004<br />

30.11.2007<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.3.2005<br />

31.12.2006


EN<br />

1460 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

List of cold stores in transition<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship, Dolnos´la˛skie<br />

1. 02641101 NORDIS Chłodnie<br />

Polskie Sp. z o.o<br />

2. 02641102 NORDIS Chłodnie<br />

Polskie Sp. z o.o<br />

Voivodship, Lubelskie<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (f)<br />

Annex I, Chapter I, point 2(b)<br />

Annex I, Chapter I, point 4(c), (e)<br />

Annex I, Chapter I, points 11, 12<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (f)<br />

Annex I, Chapter I, point 2(a)<br />

Annex I, Chapter I, point 4(a), (b)<br />

Annex I, Chapter I, point 11<br />

3. 06631102 ‘AGRAM’ Chłodnia S.A. Directive 64/433:<br />

Annex I, Chapter I, point 1(b), (c), (f), (g),<br />

Annex I, Chapter I, point 4(a), (b)<br />

Annex I, Chapter I, point 12<br />

Annex I, Chapter III, point 15(a), (b), (c), (d)<br />

Annex I, Chapter IV, point 16(a), (b)<br />

Directive 77/99:<br />

Annex A, Chapter I, points 1, 4, 8, 15<br />

Annex A, Chapter I, point 2(b), (c), (d), (e),<br />

(g), (h)<br />

4. 06641101 Chłodnia ‘MORS’ Sp. z o.o Directive 64/433:<br />

Annex I, Chapter I, point 1(c)<br />

Annex I, Chapter I, point 4(a), (c)<br />

Annex I, Chapter I, points 6, 7, 11, 12<br />

Annex I, Chapter IV, point 17(b)<br />

Voivodship, S´ wie˛tokrzyskie<br />

5. 26611101 Przedsie˛biorstwo<br />

Przemysłu Chłodniczego<br />

Chłodnia Kielce P.P.<br />

Voivodship, Wielkopolskie<br />

Directive 64/433:<br />

Annex I, Chapter I, point 1(c)<br />

Annex I, Chapter I, point 4(b), (c)<br />

nnex I, Chapter IV, point 17(a), (b)<br />

6. 30611101 PPCh ‘Calfrost’ Directive 64/433:<br />

Annex I, Chapter I, point 1(a), (b), (c), (f)<br />

Annex I, Chapter I, point 4(a), (c)<br />

Annex I, Chapter I, points 11, 13<br />

Annex I, Chapter IV, point 17(b)<br />

Date of full<br />

compliance<br />

31.12.2007<br />

30.6.2007<br />

30.11.2007<br />

31.12.2006<br />

31.12.2007<br />

31.12.2007


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1461<br />

No Vet. No Name of the establishment Shortcomings<br />

7. 30641101 Przedsie˛biorstwo<br />

Przemysłu Chłodniczego<br />

Directive 64/433:<br />

Annex I, Chapter I, point 4(c)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter IV, point 17(a)<br />

List of fish processing plants in transition<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship Dolnos´la˛skie<br />

1. 02081802 ‘Doral’ P. Chmielewski,<br />

R. Kalinowski, J. Sierakowski,<br />

S.j. jawna<br />

Voivodship Lubelskie<br />

Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(c), (e)<br />

2. 06611801 PHU ‘Elmar’ Lesiuk, Sp. jawna Directive 91/493:<br />

Annex, Chapter III. I, point 2(b), (c), (e), (f),<br />

(g), (h)<br />

Annex, Chapter III. I, points 4, 9, 10, 11<br />

Annex, Chapter IV.IV, point 5<br />

Annex, Chapter VI, point 4<br />

3. 06611802 Zakład Przetwórstwa Ryb Directive 91/493,<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e), (h)<br />

Annex, Chapter III. I, points 4, 9<br />

Voivodship Łódzkie<br />

4. 10031801 PHU ‘Słodmor’ Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (g)<br />

Annex, Chapter III. I, points 9, 11<br />

5. 10141801 PPH ‘Morfish’, Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(c), (d), (e)<br />

Annex, Chapter III. I, points 3, 6, 10, 11<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter IV.IV, point 5<br />

Voivodship Mazowieckie<br />

6. 14041802 PPH ‘Homar’ H.Kalinowski,<br />

R.Kalinowski, S.j. jawna<br />

Directive 91/493:<br />

Annex, Chapter III. I, point 2(d), (e), (h)<br />

Annex, Chapter III. I, points 3, 4, 5, 8, 10,<br />

11<br />

Date of full<br />

compliance<br />

31.10.2006<br />

Date of full<br />

compliance<br />

31.7.2005<br />

31.12.2006<br />

31.10.2006<br />

30.9.2006<br />

31.12.2005<br />

31.3.2006


EN<br />

1462 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter IV.IV, points 5, 6<br />

Annex, Chapter VI, point 4<br />

7. 14191801 ZPR ‘Fileryb’ s.c. Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(f), (g)<br />

Annex, Chapter III. I, points 3, 4, 9, 10<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter VI, point 4<br />

8. 14191802 P. PHU ‘Manta’ ZPR Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e), (f), (g), (h)<br />

Annex, Chapter III. I, points 3, 4, 5, 6, 9, 10,<br />

11<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter IV.IV, points 5, 6<br />

Annex, Chapter VI, point 4<br />

9. 14311802 ‘Bogmar Traper’,<br />

Sp. z o.o<br />

M. Janas<br />

Voivodship Podkarpackie<br />

Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(c), (b), (d), (e),<br />

(f), (g)<br />

Annex, Chapter III. I, points 3, 5, 9, 10, 11<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter VI, point 4<br />

10. 18041801 ‘Rekin’ Sp. z o.o Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d)<br />

Annex, Chapter III. I, points 3, 9, 10<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter VI, point 4<br />

Voivodship Podlaskie<br />

11. 20041801 ZPR ‘Dymek’ sp.j. Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(c), (d), (e)<br />

Annex, Chapter III. I, points 3, 9, 11<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter IV.IV, points 5, 6<br />

Annex, Chapter VI, point 4<br />

Date of full<br />

compliance<br />

31.7.2006<br />

30.6.2006<br />

31.12.2006<br />

30.9.2005<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1463<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship Pomorskie<br />

12. 22081806 ZPR ‘ASAR’ Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(d), (e), (f)<br />

Annex, Chapter III. I, points 3, 7, 8, 9, 10,<br />

11<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter IV.IV, point 4(b)<br />

Annex, Chapter IV.IV, point 6<br />

Annex, Chapter VI, point 4<br />

13. 22111807 ‘Laguna’ s.j. Directive 91/493:<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex, Chapter III. I, points 8, 11<br />

14. 22111813 PPH ‘Pikling’ s.c.<br />

E. Kosecki & K. Strachanowski<br />

Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (b), (c), (g)<br />

Annex, Chapter III. I, points 8, 9, 10, 11<br />

Annex, Chapter IV.IV, point 5<br />

15. 22121805 ZPR ‘Błe˛kitek’ Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(c), (d), (g), (h)<br />

Annex, Chapter III. I, points 9, 10, 11<br />

Annex, Chapter VI, point 4<br />

16. 22121811 PHUP ‘Pirs’ s.c. J. Prykiel J.<br />

Nadolska<br />

17. 22121821 ‘Szprot’ s.c. R.Giedrys´ i K.<br />

Krzymuski<br />

Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (d), (e)<br />

Annex, Chapter III. I, points 5, 9, 10<br />

Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(d), (g)<br />

Annex, Chapter III. I, points 3, 9<br />

Annex, Chapter IV.II, point 1<br />

18. 22621802 ‘Syrena’ Royal Sp. z o.o Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(b), (c), (e), (f)<br />

Annex, Chapter III. I, points 3, 5, 8, 11<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter IV.IV, point 4(b)<br />

Annex, Chapter VI, point 4<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2005<br />

31.12.2004<br />

31.12.2005<br />

31.12.2005<br />

30.6.2006<br />

30.6.2006


EN<br />

1464 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship S´ la˛skie<br />

19. 24021801 PHP ‘Krybekx’ Directive 91/493:<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex, Chapter III. I, points 9, 11<br />

20. 24021802 PHU ‘Komers-Mag’ s.j. Directive 91/493:<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex, Chapter III. I, points 9, 11<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter IV.IV, point 6<br />

Annex, Chapter VI, point 4<br />

21. 24041802 PPHU ‘Hur-Pol’ Directive 91/493:<br />

Annex, Chapter III. I, point 2(c), (d), (g), (h)<br />

22. 24041804 PHP ‘Konsum’ bis Directive 91/493:<br />

Annex, Chapter III. I, point 2(c), (d), (g), (h)<br />

Annex, Chapter III. I, points 5, 6, 9, 11<br />

Annex, Chapter VI, point 4<br />

23. 24171801 PPHU ‘Tuńczyk’, J. Ba˛k, A.<br />

Walaszek, s.j.<br />

Voivodship Warmińsko-Mazurskie<br />

Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e), (g), (h)<br />

Annex, Chapter III. I, points 3, 5, 6, 8, 11<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter IV.IV, point 5<br />

Annex, Chapter VI, point 4<br />

24. 28031801 ‘Atryb’ Sp. z o.o Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex, Chapter III. I, points 4, 6, 8, 10, 11<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter IV.IV, points 5, 6<br />

Annex, Chapter VI, point 4<br />

25. 28051801 Przetwórstwo i We˛dzenie Ryb Directive 91/493:<br />

Annex, Chapter III. I, point 2(g)<br />

Annex, Chapter III. I, points 6, 9<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter IV.IV, point 5<br />

26. 28051802 PW ‘Doryb’ Directive 91/493:<br />

Annex, Chapter III. I, point 2(g)<br />

Annex, Chapter III. I, points 6, 9, 11<br />

Annex, Chapter IV.IV, point 5<br />

Date of full<br />

compliance<br />

31.12.2006<br />

30.6.2005<br />

31.7.2004<br />

31.12.2006<br />

31.12.2006<br />

31.10.2005<br />

31.12.2006<br />

30.6.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1465<br />

No Vet. No Name of the establishment Shortcomings<br />

27. 28051803 Gospodarstwo Rybackie<br />

Sp. z o.o<br />

Directive 91/493:<br />

Annex, Chapter III. I, point 2(g)<br />

Annex, Chapter III. I, points 8, 9<br />

Annex, Chapter IV.IV, point 5<br />

28. 28111801 PPHU ‘Tamir’ M. Ilicz Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(c), (d), (h)<br />

Annex, Chapter III. I, points 6, 10, 11<br />

Voivodship Wielkopolskie<br />

29. 30141801 ZPH ‘Sol-Fish’ s.j. jawna Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e), (g), (h)<br />

Annex, Chapter III. I, points 3, 6, 7, 8, 10,<br />

11<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter VI, point 4<br />

30. 30221801 PHU ‘Panix’ P. Niziołek Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(c), (d), (e)<br />

Annex, Chapter III. I, points 3, 5, 9, 10, 11<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter IV.IV, points 5, 6<br />

Annex, Chapter VI, point 4<br />

Voivodship Zachodniopomorskie<br />

31. 32031801 ZPUH Z. Stebnicki Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e), (f), (h)<br />

Annex, Chapter III. I, points 3, 5, 6, 8, 9, 10,<br />

11<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter IV.IV, points 5, 6<br />

Annex, Chapter VI, point 4<br />

32. 32071804 PPH ‘Mors’ M. Wdzie˛czny Directive 91/493:<br />

Annex, Chapter III. I, point 2(c), (d), (h)<br />

Annex, Chapter III. I, points 8, 9, 10, 11<br />

33. 32081807 PPAS ‘Zgoda’ Sp. z o.o Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e), (f), (g)<br />

Annex, Chapter III. I, point 9<br />

34. 32081808 HPU ‘Tuka’ M. Pozorski J.<br />

Szyszko, S.j. Jawna<br />

Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(e)<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006<br />

31.12.2005<br />

30.4.2006<br />

31.10.2005<br />

31.8.2006<br />

31.1.2006


EN<br />

1466 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex, Chapter III. I, points 3, 6, 9<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter VI, point 4<br />

35. 32081814 PPH ‘Tunex’ Kobylińscy Directive 91/493:<br />

Annex, Chapter III. I, point 2(a), (b), (c)<br />

36. 32081816 ZPR ‘Barkas’ E. S´ widerek Directive 91/493:<br />

Annex, Chapter III. I, point 1<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex, Chapter III. I, points 3, 9, 11<br />

Annex, Chapter IV.II, point 1<br />

Annex, Chapter IV.IV, point 5<br />

Annex, Chapter VI, point 4<br />

37. 32081821 ZPR ‘Baltic – Fish’ Directive 91/493:<br />

Annex, Chapter III. I, point 2(c)<br />

38. 32081822 PAS ‘Alta’ Directive 91/493:<br />

Annex, Chapter III. I, point 2(c), (e)<br />

Annex, Chapter III. I, point 9<br />

39. 32081823 ZPR ‘Łosos´’ s.c Directive 91/493:<br />

Annex, Chapter III. I, point 2(c)<br />

40. 32091804 PPUH ‘Polryb’ Maszkowie Directive 91/493:<br />

Annex, Chapter III. I, point 2(a), (b), (c), (d),<br />

(e), (h)<br />

Annex, Chapter III. I, point 11<br />

Annex, Chapter IV.I, point 3<br />

Annex, Chapter VI, point 4<br />

List of milk establishments in transition<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship Dolnos´la˛skie<br />

1. 02011601 OSM Bolesławiec Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (d), (g)<br />

Annex B, Chapter I, point 3(a), (d), (g)<br />

Annex B, Chapter I, points 4, 10, 11<br />

Annex B, Chapter V, point f1<br />

2. 02031601 Obrzańska SM w<br />

Kos´cianie, Oddz. Produkcyjny<br />

Brzeg<br />

Głogowski<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Date of full<br />

compliance<br />

31.12.2004<br />

31.12.2006<br />

31.12.2004<br />

31.12.2005<br />

31.12.2004<br />

31.12.2006<br />

Date of full<br />

compliance<br />

31.10.2006<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1467<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter V, points c, f1<br />

3. 02051601 OSM Paszowice Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter V, points b, c, f1<br />

4. 02111601 OSM Lubin Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, c, f1<br />

5. 02111602 OSM Lubin, Oddz. w<br />

S´ cinawie<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, c, f1<br />

6. 02201611 OSM Trzebnica Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(g)<br />

Annex B, Chapter I, points 4, 8, 9, 10<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, c, f1<br />

7. 02221601 OSM Wołów Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 8, 10, 11<br />

Annex B, Chapter V, point f1<br />

Voivodship Kujawsko – Pomorskie<br />

8. 04041603 ZM w Brzozowie,<br />

Brzozowo<br />

Directive 92/46:<br />

Annex B, Chapter I, point 11<br />

Date of full<br />

compliance<br />

30.11.2006<br />

30.6.2006<br />

30.6.2006<br />

30.11.2006<br />

31.12.2006<br />

30.11.2005


EN<br />

1468 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

9. 04621601 Grudzia˛dzka SM Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b)<br />

Annex B, Chapter I, point 3(a), (b), (e)<br />

Annex B, Chapter I, points 4, 8, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

10. 04021601 MPPH, ‘Bromilk’<br />

Sp. z o.o<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(b), (c), (e)<br />

Annex B, Chapter I, point 3(b), (c), (e)<br />

Annex B, Chapter I, points 4, 9, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

11. 04141601 SM ‘S´ wiecka’ Directive 92/46:<br />

Annex B, Chapter I, point 8<br />

Annex B, Chapter V, point f1<br />

12. 04081601 PPHU ‘Agromlecz’<br />

Sp. z o.o<br />

Voivodship Lubelskie<br />

13. 06051601 OKRE˛GOWAS<br />

SPÓŁDZIELNIA<br />

MLECZARSKA<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex B, Chapter I, point 4<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point c<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(c), (e), (g)<br />

Annex B, Chapter I, points 4, 8, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

14. 06051602 PPHU ‘Ser- Vita’ Directive 92/46:<br />

Annex B, Chapter I, point 2(g)<br />

Annex B, Chapter I, point 3g<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter V, point f1<br />

15. 06111601 SM Łuków Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e)<br />

Annex B, Chapter I, points 4, 8, 9, 11<br />

16. 06181601 Tomaszowska SM Directive 92/46:<br />

Annex B, Chapter I, points 1, 8<br />

Annex B, Chapter III<br />

17. 06091601 OSM Bychawa Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(d)<br />

Date of full<br />

compliance<br />

30.9.2006<br />

30.9.2006<br />

30.6.2006<br />

30.4.2006<br />

31.12.2006<br />

31.10.2006<br />

30.9.2006<br />

31.12.2006<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1469<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship Lubuskie<br />

Annex B, Chapter I, point 3(d), (g)<br />

Annex B, Chapter I, points 9, 11<br />

Annex B, Chapter III<br />

18. 08611601 OSM Gorzów Wlkp. Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e)<br />

Annex B, Chapter I, point 11<br />

19. 08021601 OSM Krosno Odrzańskie, Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (d)<br />

Annex B, Chapter I, point 3(a), (b), (d)<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

20. 08031601 OSM Mie˛dzyrzecz Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c)<br />

Annex B, Chapter I, point 3(a), (b), (c)<br />

Annex B, Chapter V, point f1<br />

21. 08041603 ZPS i H H. Kuz´ma Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 11<br />

Annex B, Chapter V, point f1<br />

22. 08051601 ‘Osmos’ Sp. z o.o w<br />

upadłos´ci<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (c), (d), (e),<br />

(g)<br />

Annex B, Chapter I, point 3(c), (d), (e), (g)<br />

Annex B, Chapter I, points 9, 11<br />

Annex B, Chapter V, point f1<br />

23. 08101601 OSM w Szprotawie Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(b), (c), (d)<br />

Annex B, Chapter I, point 3(b), (d)<br />

Annex B, Chapter I, points 4, 8<br />

Annex B, Chapter V, point f1<br />

24. 08101602 OSM w Szprotawie, Oddz.<br />

Produkcyjny w<br />

Siecioborzycach<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(b), (c), (d), (e),<br />

(g)<br />

Annex B, Chapter I, point 3(c), (d), (e), (g)<br />

Date of full<br />

compliance<br />

31.10.2006<br />

30.11.2006<br />

31.3.2006<br />

31.10.2006<br />

30.6.2006<br />

31.12.2006<br />

31.12.2006


EN<br />

1470 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter V, point f1<br />

25. 08061601 Strzelecka SM Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter V, points b, c, f1<br />

Voivodship Łódzkie<br />

26. 10081601 OSM Pabianice Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (d)<br />

Annex B, Chapter I, point 3(a), (d)<br />

Annex B, Chapter I, points 4, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

27. 10081602 ZM ‘Zare˛bski’ Directive 92/46:<br />

Annex B, Chapter I, points 1, 4, 11<br />

28. 10611602 ‘Bruser’ Sp. z o.o Directive 92/46:<br />

Annex B, Chapter I, points 1<br />

Annex B, Chapter I, point 2(a), (c), (d)<br />

Annex B, Chapter I, point 3(b), (c), (d)<br />

Annex B, Chapter I, points 4, 9, 10, 11<br />

Annex B, Chapter V, points c, f1<br />

29. 10061601 Łódzka SM<br />

Oddział Karczew<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, c, f1<br />

30. 10201601 OSM w Ozorkowie Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (c)<br />

Annex B, Chapter I, point 3(a), (b), (c)<br />

Annex B, Chapter I, point 8<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

31. 10131601 SM Rawa Mazowiecka Directive 92/46:<br />

Annex B, Chapter I, point 2(b), (c), (d), (e)<br />

Annex B, Chapter I, point 3(b), (c), (d), (e)<br />

Annex B, Chapter I, point 4<br />

Date of full<br />

compliance<br />

30.11.2006<br />

31.12.2006<br />

31.5.2006<br />

31.12.2006<br />

31.12.2006<br />

31.3.2006<br />

30.11.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1471<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

32. 10021602 OSM ‘Proszkownia’ Directive 92/46:<br />

Annex B, Chapter I, point 1,<br />

Annex B, Chapter I, point 2(b), (c), (d)<br />

Annex B, Chapter I, point 3(b), (c), (d)<br />

Annex B, Chapter I, points 4, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

Voivodship Małopolskie<br />

33. 12011602 FPHU Mleczarnia ‘Ekomilk’ Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d)<br />

Annex B, Chapter I, points 4, 9, 11<br />

Annex B, Chapter V, points c, f1<br />

34. 12061601 OSM Skała Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d)<br />

Annex B, Chapter I, point 3(c), (d), (g)<br />

Annex B, Chapter I, points 4, 8, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

35. 12081601 Oddz. Produkcyjny w<br />

Charsznicy<br />

OSM Miechów<br />

36. 12081602 Oddz. Produkcyjny w<br />

Miechowie,<br />

ul. B. Prusa 5, 32-200<br />

Miechów,<br />

OSM Miechów<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(b), (c), (d), (e)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 8, 9, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points c, f1<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(e)<br />

Annex B, Chapter I, point 3(e)<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points c, f1<br />

37. 12161603 SM Przybysławice 83 Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex B, Chapter I, point 3(a), (d), (e), (g)<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter V, point f1<br />

38. 12181601 OSM ‘Wadmlek’ Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.10.2006<br />

31.12.2006<br />

31.10.2006<br />

31.10.2006<br />

31.12.2006<br />

31.12.2006


EN<br />

1472 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex B, Chapter I, point 3(b), (c), (d), (e),<br />

(g)<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point b<br />

39. 12181602 SM Wieprz Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (g)<br />

Annex B, Chapter I, points 4, 11<br />

Annex B, Chapter III<br />

40. 12111601 SM Nowy Targ Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (c), (d), (e)<br />

Annex B, Chapter I, point 3(a), (b), (d), (e)<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter III<br />

41. 12111602 ZPJ ‘Magda’ Directive 92/46:<br />

Annex B, Chapter I, point 2(e), (g)<br />

Annex B, Chapter I, point 3(e), (g)<br />

Annex B, Chapter I, points 8, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point c<br />

42. 12171602 PM Białka Tatrzańska Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d)<br />

Annex B, Chapter I, point 11<br />

43. 12171601 Podhalańska SM w<br />

Zakopanem<br />

Voivodship Mazowieckie<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (d), (g)<br />

Annex B, Chapter I, point 3(a), (b), (d), (g)<br />

Annex B, Chapter I, points 8, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points c, f1<br />

44. 14041601 OSM Sanniki Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, c, f1<br />

45. 14221603 SM ‘Mazowsze’ Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(c), (e), (g)<br />

Annex B, Chapter I, point 3(c), (e), (g)<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.8.2006<br />

30.6.2006<br />

31.12.2006<br />

31.12.2006<br />

30.4.2006<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1473<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points c, f1<br />

46. 14371601 SM Z˙uromin Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(g)<br />

Annex B, Chapter I, points 8, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point c<br />

47. 14111602 ‘Nargo’ s.j.<br />

A.H. Nartonowicz<br />

Voivodship Opolskie<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(c), (d), (e), (g)<br />

Annex B, Chapter I, point 4, 10, 11<br />

Annex B, Chapter V, points, f1<br />

48. 16011601 OSM Brzeg Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3b, (c), (d), (e), (g)<br />

Annex B, Chapter I, points 4, 8, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

49. 16041602 ‘Kaniak’ Sp. z o.o Directive 92/46:<br />

Annex B, Chapter I, point 1,<br />

Annex B, Chapter I, point 2(a), (b), (c), (e),<br />

Annex B, Chapter I, point 3(a), (e),<br />

Annex B, Chapter I, point 11<br />

Voivodship Podkarpackie<br />

50. 18101602 OSM w Łańcucie, Oddział<br />

Produkcyjny Białobrzegi<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d)<br />

Annex B, Chapter I, points 9, 11<br />

Annex B, Chapter V, point f1<br />

51. 18111601 OSM w Mielcu Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (d), (e)<br />

Annex B, Chapter I, points 8, 11<br />

Annex B, Chapter V, points b, f1<br />

Date of full<br />

compliance<br />

31.12.2006<br />

30.11.2006<br />

31.10.2006<br />

31.12.2006<br />

30.6.2006<br />

31.12.2006


EN<br />

1474 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

52. 18151601 OSM w Se˛dziszowie<br />

Małopolskim<br />

53. 18071602 OSM w Sanoku, Zakład<br />

Bryndzarski w Rymanowie<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(b), (c), (d), (g)<br />

Annex B, Chapter I, points 4, 11<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(d), (g)<br />

Annex B, Chapter I, point 3(b), (d)<br />

Annex B, Chapter I, point 4<br />

54. 18181601 OSM w Stalowej Woli Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a)<br />

Annex B, Chapter I, point 3(a)<br />

Annex B, Chapter I, points 4, 8<br />

Annex B, Chapter V, point f1<br />

Voivodship Podlaskie<br />

55. 20011601 Augustowska SM Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (e)<br />

Annex B, Chapter I, point 3(a), (b)<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

56. 20121601 SM ‘Rospuda’ w Filipowie Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (c), (d), (e)<br />

Annex B, Chapter I, point 3(a), (c), (d), (e)<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

57. 20111601 OSM Da˛browa Białostocka Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 9, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points c, f1<br />

58. 20091601 SM ‘Mlekpol’ w Grajewie,<br />

Zakład Produkcji<br />

Mleczarskiej ‘SejnMlek’ w<br />

Sejnach<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

Date of full<br />

compliance<br />

30.11.2006<br />

31.12.2006<br />

30.9.2006<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1475<br />

No Vet. No Name of the establishment Shortcomings<br />

Voivodship Pomorskie<br />

59. 22031601 OSM Człuchów Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (e)<br />

Annex B, Chapter I, point 3(a), (b), (c), (e)<br />

Annex B, Chapter I, points 4, 8, 9, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, c, f1<br />

60. 22151604 ZM ‘S´ niez˙ka’ Perlino Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(d), (e), (g)<br />

Annex B, Chapter I, point 3(d), (e), (g)<br />

Annex B, Chapter I, points 4, 11<br />

Annex B, Chapter V, point f1<br />

Voivodship S´ la˛skie<br />

61. 24021601 SM ‘Biel-Ser’ Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (e),<br />

(g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 11<br />

Annex B, Chapter V, points c, f1<br />

62. 24021606 ‘Grzes´mlecz’ S.A. Bielsko-Biała<br />

Zakład Produkcji Bystra<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(d), (g)<br />

Annex B, Chapter I, point 3(d), (g)<br />

Annex B, Chapter I, points 8, 9, 11<br />

Annex B, Chapter V, point c<br />

63. 24031601 OSM Skoczów Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (c), (d), (g)<br />

Annex B, Chapter I, point 3(a), (c), (d), (g)<br />

Annex B, Chapter I, points 4, 11<br />

Annex B, Chapter V, point f1<br />

64. 24641601 Cze˛stochowska SM<br />

‘Mleczgal’<br />

65. 24041601 PPH ‘Pak’ A.P.<br />

Kwiatkowscy<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 11<br />

Annex B, Chapter V, point f1<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1,<br />

Annex B, Chapter I, point 2(a), (b), (c), (e),<br />

(g)<br />

Date of full<br />

compliance<br />

30.11.2006<br />

31.10.2006<br />

31.12.2006<br />

30.6.2006<br />

31.10.2006<br />

30.4.2006<br />

31.10.2006


EN<br />

1476 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

Annex B, Chapter I, point 3(a), (b), (c), (e),<br />

(g)<br />

Annex B, Chapter I, points 4, 8, 9, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points c, f1<br />

66. 24781601 OSM w Zabrzu Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (e)<br />

Annex B, Chapter I, point 3(e)<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter V, point f1<br />

67. 24061601 OSM Kłobuck Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, c, f1<br />

68. 24061602 OSM Krzepice Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (e),<br />

(g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, c, f1<br />

69. 24071601 OSM Lubliniec-Dobrodzień Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter V, points b, c, f1<br />

70. 24101601 OSM Pszczyna Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (g)<br />

Annex B, Chapter I, point 3(a), (b), (d), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points c, f1<br />

71. 24141602 OSM Bieruń Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(b), (c)<br />

Annex B, Chapter I, point 4<br />

Annex B, Chapter V, point f1<br />

Date of full<br />

compliance<br />

31.10.2006<br />

31.12.2006<br />

31.12.2006<br />

30.9.2006<br />

31.12.2006<br />

30.6.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1477<br />

No Vet. No Name of the establishment Shortcomings<br />

72. 24151601 OSM Bełsznica Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter V, point f1<br />

73. 24161601 OSM w Pilicy Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d)<br />

Annex B, Chapter I, point 8<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

74. 24161602 OSM ‘Rokitnianka’ w<br />

Szczekocinach<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (e)<br />

Annex B, Chapter I, point 3(a), (b)<br />

Annex B, Chapter I, points 4, 8, 9<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

75. 24171601 OSM ‘Zyw-Mlecz’ Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, c, f1<br />

Voivodship S´ wie˛tokrzyskie<br />

76. 26021601 OSM w Je˛drzejowie, Zakład<br />

Produkcyjny w Je˛drzejowie<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(d)<br />

Annex B, Chapter I, point 3d<br />

Annex B, Chapter I, points 4, 9, 11<br />

77. 26021602 OSM WODZISŁAW Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(d)<br />

Annex B, Chapter I, point 3(d)<br />

Annex B, Chapter I, points 4, 9, 11<br />

78. 26041601 OSM w Chmielniku Directive 92/46:<br />

Annex B, Chapter I, point 2(b), (c), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 8, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points c, f1<br />

Date of full<br />

compliance<br />

31.10.2006<br />

31.12.2005<br />

31.12.2006<br />

30.11.2006<br />

30.11.2006<br />

31.10.2005<br />

31.12.2006


EN<br />

1478 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

79. 26061601 OSM w Bidzinach Directive 92/46:<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, c, f1<br />

80. 26061602 OSM w Opatowie Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 11<br />

Annex B, Chapter V, points b, f1<br />

81. 26071601 OSM w Ostrowcu<br />

S´ wie˛tokrzyskim<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex B, Chapter I, point 3(d)<br />

Annex B, Chapter I, points 8, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

82. 26091601 OSM w Sandomierzu Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(c), (g)<br />

Annex B, Chapter I, point 3(c), (g)<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter III<br />

83. 26121601 OSM w Bidzinach, Zakład<br />

Produkcyjny w Staszowie<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(b), (c), (d), (e),<br />

(g)<br />

Annex B, Chapter I, point 3(b), (c), (d), (e),<br />

(g)<br />

Annex B, Chapter I, points 8, 9, 10, 11<br />

Annex B, Chapter III<br />

84. 26611601 OSM ‘Radostowa’ Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(b), (c), (e)<br />

Annex B, Chapter I, point 3(b), (c), (d), (e)<br />

Annex B, Chapter I, point 9<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points c, f1<br />

Voivodship Warmińsko — Mazurskie<br />

85. 28011601 SM ‘Maćkowy’ w Gdańsku, O/<br />

Górowo Iławeckie<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e)<br />

Annex B, Chapter I, point 3(e), (g)<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

Date of full<br />

compliance<br />

30.9.2006<br />

31.12.2006<br />

31.12.2006<br />

31.10.2006<br />

31.12.2006<br />

31.12.2006<br />

30.9.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1479<br />

No Vet. No Name of the establishment Shortcomings<br />

86. 28041603 Elbla˛ska SM, Zakład<br />

Produkcyjny Młynary<br />

87. 28071602 SM w Lubawie, Zakład<br />

Produkcyjny w Iławie<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, f1<br />

88. 28071603 OSM Susz Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 8, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points c, f1<br />

89. 28071604 OSM w Suszu Oddz.<br />

produkcyjny w Kisielicach<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 8, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

90. 28111601 OSM Nidzica Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c)<br />

Annex B, Chapter I, point 3(a), (b)<br />

Annex B, Chapter I, point 9<br />

Annex B, Chapter III<br />

Annex B, Chapter V, point f1<br />

Voivodship Wielkopolskie<br />

91. 30031601 Rolnicza SM ‘Rolmlecz’<br />

Zakład Mleczarski w<br />

Gniez´nie<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter V, points b, c, f1<br />

Date of full<br />

compliance<br />

31.12.2006<br />

30.9.2006<br />

30.9.2006<br />

30.9.2006<br />

31.12.2006<br />

31.10.2006


EN<br />

1480 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

92. 30031602 SM w Witkowie Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter V, points b, c, f1<br />

93. 30061601 OSM w Jarocinie Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(e)<br />

Annex B, Chapter I, point 4<br />

94. 30111602 OSM -S´ rem Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (d), (e)<br />

Annex B, Chapter I, point 3(a), (d), (e)<br />

Annex B, Chapter I, points 4, 8, 11<br />

Annex B, Chapter V, point f1<br />

95. 30111603 ‘Champion’ Sp. z o.o Directive 92/46:<br />

Annex B, Chapter I, point 2(a)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d)<br />

Annex B, Chapter Vc<br />

96. 30111607 SPRiP ‘Nowa Droga’ Directive 92/46:<br />

Annex B, Chapter I, point 2(c), (d), (g)<br />

Annex B, Chapter I, point 3(c), (d), (g)<br />

Annex B, Chapter I, points 4, 8, 11<br />

97. 30121602 OSM Kalisz, Zakład<br />

Produkcyjny w Koz´minie<br />

Wikp.<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (e)<br />

Annex B, Chapter I, point 3(e)<br />

Annex B, Chapter V, point f1<br />

98. 30131601 Mleczarnia J. Korbik Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 4<br />

99. 30131602 PPH ‘Emma’ E Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (d), (g)<br />

Annex B, Chapter I, point 3(a)<br />

Annex B, Chapter I, point 11<br />

100. 30141601 Celia Polska Sp. z o.o Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (c)<br />

Annex B, Chapter I, point 3(a), (e)<br />

Annex B, Chapter I, points 9, 11<br />

Annex B, Chapter V, point f1<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2006<br />

31.8.2006<br />

30.6.2005<br />

31.10.2006<br />

31.12.2006<br />

31.10.2005<br />

31.12.2005<br />

31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1481<br />

No Vet. No Name of the establishment Shortcomings<br />

101. 30151601 OSM ‘Top-Tomys´l’ Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(c), (e)<br />

Annex B, Chapter I, point 3(c)<br />

102. 30171601 OSM Ostrów Wikp. Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (d), (g)<br />

Annex B, Chapter I, point 3(g)<br />

Annex B, Chapter I, point 11<br />

Annex B, Chapter V, point c<br />

103. 30201601 OSM Kowalew - Dobrzyca<br />

Zakład Kowalew<br />

104. 30201602 OSM Kowalew - Dobrzyca,<br />

Zakład Dobrzyca<br />

105. 30211605 Akademia Rolnicza Rolnicze<br />

Gospodarstwo<br />

Dos´wiadczalne AR<br />

‘Złotniki’<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (e),<br />

(g)<br />

Annex B, Chapter I, point 3(a), (b), (e), (g)<br />

Annex B, Chapter I, points 4, 11<br />

Annex B, Chapter V, point f1<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (e)<br />

Annex B, Chapter I, point 3(a), (b), (e)<br />

Annex B, Chapter I, point 4<br />

Annex B, Chapter V, point f1<br />

Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (e)<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points f1<br />

106. 30221601 OSM w Rawiczu Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(c), (d)<br />

Annex B, Chapter I, point 3(g)<br />

107. 30231601 SM Udziałowców Directive 92/46:<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter V, points c, f1<br />

108. 30241602 OSM Kaz´mierz Wlkp., Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 4, 8, 9, 10, 11<br />

Annex B, Chapter III<br />

Annex B, Chapter V, points b, c<br />

Date of full<br />

compliance<br />

31.12.2006<br />

31.12.2006<br />

31.10.2006<br />

30.9.2006<br />

31.12.2005<br />

31.10.2006<br />

31.12.2006<br />

31.12.2006


EN<br />

1482 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. No Name of the establishment Shortcomings<br />

109. 30251602 ZP ‘Milk’ D. Sumelka Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(g)<br />

Annex B, Chapter I, point 3(g)<br />

110. 30281601 ZPM ‘Mlecz’ Wolsztyn, Oddział<br />

Damasławek<br />

Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(d), (e), (g)<br />

Annex B, Chapter I, points 9, 11<br />

Annex B, Chapter V, point f1<br />

111. 30301601 SM Wrzes´nia Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(c)<br />

Annex B, Chapter I, points 4, 8, 11<br />

Annex B, Chapter V, point f1<br />

Voivodship Zachodnio – Pomorskie<br />

112. 32071601 OSM Kamień Pomorski Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(d), (e)<br />

Annex B, Chapter I, point 3(d), (e)<br />

113. 32151601 ‘Elmilk’ Sp. z o.o Directive 92/46:<br />

Annex B, Chapter I, point 1<br />

Annex B, Chapter I, point 2(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, point 3(a), (b), (c), (d),<br />

(e), (g)<br />

Annex B, Chapter I, points 8, 9, 11<br />

Annex B, Chapter V, point f1<br />

Date of full<br />

compliance<br />

31.10.2006<br />

31.12.2006<br />

31.12.2006<br />

30.11.2006<br />

31.12.2006<br />

List of establishments allowed to process EU compliant and non-compliant milk and expiring dates of transitional<br />

periods<br />

No Vet. number Name of the establishment<br />

End of transitional<br />

period<br />

1 B1 14281601 ZM ‘Bakoma’ S.A. 30.6.2006<br />

2 B1 20021601 SM Łapy 30.6.2006<br />

3 B1 08111601 SM Z˙ary 30.6.2006<br />

4 B1 04631601 Toruńska SM 30.6.2006<br />

5 A 04121601 SM ‘ROTR’ 30.6.2006<br />

6 B1 04021603 ‘AGROCOMEX’ Sp. z o.o 30.6.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1483<br />

No Vet. number Name of the establishment<br />

End of transitional<br />

period<br />

7 A 20101601 ‘Polser’ Sp. z o.o 30.6.2006<br />

8 B1 14291602 OSM Kosów 30.6.2006<br />

9 A 20041601 SM ‘Mlekpol’ 30.6.2006<br />

10 B1 30111601 Obrzańska SM 30.6.2006<br />

11 B1 14111604 ‘Onken Andex’ Sp. z o.o 30.6.2006<br />

12 A 20131601 SM ‘Mlekowita’ 30.6.2006<br />

13 A 30091601 OSM Koło 30.6.2006<br />

14 B1 14261601 OSM Siedlce 30.6.2006<br />

15 B1 32141601 OSM Stargard Szczeciński 30.6.2006<br />

16 B1 20081601 Moniecka SM w Mońkach 30.6.2006<br />

17 A 30291601 ZPM ‘MLECZ’ 30.6.2006<br />

18 B1 14201603 OSM Racia˛z˙ 30.6.2006<br />

19 B1 10051601 OSM Łowicz 30.6.2006<br />

20 B1 06161601 SM ‘Ryki’ 30.6.2006<br />

21 B1 20051601 OSM Hajnówka 30.6.2006<br />

22 B1 02041601 SM ‘DEMI’ 30.6.2006<br />

23 B1 04641601 Kujawska SM 30.6.2006<br />

24 B1 20111602 SM ‘SOMLEK’ 30.6.2006<br />

25 A 32081602 ‘Arla Foods’ Sp. z o.o Gos´cino 30.6.2006<br />

26 A 14221602 SM ‘Mazowsze’ 30.6.2006<br />

27 B1 30621601 OSM Konin 30.6.2006<br />

28 B1 04611601 SM ‘OSOWA’ 30.6.2006<br />

29 A 14221601 ‘BELL-Polska’ Sp. z o.o 30.6.2006<br />

30 B1 20631601 SM ‘Sudowia’ w Suwałkach 31.12.2006<br />

31 B1 14031601 OSM w Garwolinie 31.12.2005<br />

32 A 20631602 PPHU ‘Lactopol’ Sp. z o.o w Suwałkach 31.12.2005<br />

33 B1 14021601 OSM Ciechanów 31.12.2005<br />

34 A 16611601 ‘ZOTT Polska’ Sp. z o.o 31.12.2005


EN<br />

1484 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No Vet. number Name of the establishment<br />

End of transitional<br />

period<br />

35 B1 14161601 Mazowiecka SM ‘OSTROWIA’ 31.12.2005<br />

36 B1 14151603 SM Kurpie 31.12.2005<br />

37 A 10171601 Spółdzielnia Dostawców Mleka w Wieluniv 31.12.2005<br />

38 B1 30271601 Mleczarnia ‘TUREK’ Sp. z o.o 31.12.2005<br />

39 B1 10611601 Łódzka SM 31.12.2005<br />

40 B1 02071601 SM ‘KAMOS’ 31.12.2005<br />

41 A 30611601 OSM Kalisz 31.12.2005<br />

42 B1 14101601 ZM ‘Laktopol A’ 31.12.2005<br />

43 B1 26131601 OSM Włoszczowa 31.12.2005<br />

44 B1 02251601 OSM Zgorzelec 31.12.2006<br />

45 B1 10631602 OSM Skierniewice 31.12.2006<br />

46 B1 26051601 OSM w Końskich 31.12.2006<br />

47 B1 14361601 RSM ‘Rolmlecz’ 31.12.2006<br />

48 B1 24751601 SM ‘Jogser’ 31.12.2006<br />

49 A 10121601 OSM Radomsko 31.12.2006<br />

50 B1 18171601 OSM Sanok 31.12.2006<br />

51 B1 24111601 OSM Racibórz 31.12.2006<br />

52 A 04111601 Proszkownia Mleka Sp zo.o Piotrków Kujawski 31.12.2006<br />

53 A 06061601 OSM Krasnystaw 31.12.2006<br />

54 B1 18161601 RSM ‘Resmlecz’ 31.12.2006<br />

55 B1 12621601 OSM Nowy Sa˛cz 31.12.2006<br />

56 A 06181602 ZM Łaszczów 31.12.2006


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1485<br />

Appendix C<br />

referred to in Chapter 6, Section B, Subsection I, point 2 of Annex XII (*)<br />

List of establishments with non-enriched cage system subject to transitional arrangements (Directive<br />

1999/74/EC, Article 5(1), (4) and (5)<br />

ANIMAL WELFARE<br />

No<br />

1 Józef Kaczała<br />

Kurnik III<br />

56-403 SOKOŁOWICE 90 A<br />

Oles´nica/ Oles´nica<br />

Name of the establishment<br />

County/Gmina<br />

2 Artur Jaskółowski<br />

ul. Kilińskiego 13 A, 58-370 BOGUSZÓW<br />

Wałbrzych/Boguszów Gorce<br />

3 Rolnicza Spółdzielnia Produkcyjna ‘PRZYSZŁOS´ Ć’<br />

ul. Główna 264,<br />

58-312 STARE BOGACZOWICE<br />

Wałbrzych/Stare Bogaczowice<br />

4 Tadeusz Strychar<br />

Lisowice Spalona 20 a,<br />

59-216 KUNICE<br />

Legnica/Kunice<br />

5 Renata Wołczyn<br />

ul. Wróblewskiego 20,<br />

Jelenia Góra<br />

6 Rolnicza Spółdzielnia Produkcyjna ‘PRZYSZŁOS´ Ć’<br />

Ferma Czadrów<br />

Kamienna Góra/Stare Bogaczowice<br />

7 Stanisław Mazur<br />

Chomia˛z˙a, ul. 1 Maja 63/1, 55-320 MALCZYCE<br />

S´ roda S´ la˛ska/Malczyce<br />

8 Ireneusz Biedka<br />

ul S´ redzka, 55-320 MALCZYCE<br />

S´ roda S´ la˛ska/Malczyce<br />

9 Mirosław Weber<br />

Nowa Kuz´nia 76 C, 59-257 GROMADKA<br />

Golesławicki /Gromadka<br />

10 Andrzej Staszkiewicz<br />

Wszewilki/Ka˛ty, 56-300 MILICZ/ Milicz<br />

11 Marek Zgłobicki<br />

Raków 33 D, 55-093 KIEŁCZÓW/Długołe˛ka<br />

12 Mariusz Bugaj Drudewice Modrzyca<br />

ul. E. Orzeszkowej 22, 67-106 OTYŃ<br />

Nowa Sól/ Kociuchów<br />

13 Krzysztof Obarewicz<br />

Mirocin Górny 133, 67-128 MIROCIN DOLNY<br />

Nowa Sól/Koz˙uchów<br />

(*) For the text of Annex XII see OJ L 236, 23.9.2003, p. 875.<br />

Production capacity<br />

(eggs/year)<br />

(1 000)<br />

3 294<br />

6 570<br />

150 000<br />

5 000<br />

240<br />

40 000<br />

2 880<br />

Transitional measures only<br />

apply to the cages installed<br />

in 1987<br />

12 556<br />

7 000<br />

1 460<br />

3 500<br />

10 000<br />

1 000


EN<br />

1486 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

No<br />

14 Sylwester Gajewski<br />

Gruszczyce 72, 98-235 BŁASZKI<br />

Sieradz/ Błaszki<br />

15 Tadeusz Duda<br />

Zagórze 639<br />

Chrzanów/Babice<br />

Name of the establishment<br />

County/Gmina<br />

16 Danuta i Stanisław Piegzik<br />

ul. Słoneczna 22, 32-590 LIBIA˛Z˙-KOSÓWKI<br />

Chrzanowski Libia˛z˙<br />

17 Jerzy Ćwik<br />

Porza˛dzie 89, 07-205 RZA˛S´ NIK<br />

Klyszków/Rza˛s´nik<br />

18 Instytut Genetyki i Hodowli Zwierza˛t PAN, Zakład<br />

Dos´wiadczalny w Jastrze˛bcu<br />

ul. Poste˛pu 1, 05-552 WÓLKA KOSOWSKA<br />

Piaseczyński/Lesznowola<br />

19 Jerzy Diłaj<br />

Pra˛dy ul. Sportowa 1, gm. Da˛browa<br />

Opolski/Niemodlin<br />

20 Piotr Kobienia<br />

Krzanowice ul. Armii Ludowej 2,<br />

46-020 CZARNOWA˛SY<br />

Opolski/Dobrzyń Wielki<br />

21 Jan Szerla˛g<br />

Warzyce 397, Jasielski/Jasło<br />

22 Iwona Marschk<br />

Bojano, ul. Wybickiego 39, 84-207 KOLECZKOWO<br />

Wejherowo/Szemud<br />

23 Ignacy We˛sierski<br />

Chmielańskie Chrósty, 83-333 CHMIELNO<br />

Kartuzy/Chmielno<br />

24 Robert Adkonis<br />

Komikowo 10, 76-252 KWAKOWO<br />

Słupsk/Kobylnica<br />

25 ‘DROBIA’ S. A.<br />

Studzienice k/ Pszczyny, ul. Jaskółek 12,<br />

43-215 JANKOWICE<br />

Pszczyna/Pszczyna<br />

26 Rolniczy Kombinat Spółdzielczy<br />

ul. Spółdzielcza 16, 43-440 GOLESZÓW<br />

Cieszyn/Goleszów<br />

27 Jan i Maria Niemczyk<br />

Rudowka, 43-392 MIE˛DZYRZECZE DOLNE<br />

Bielski/Jasienica<br />

28 ‘DROBEK 2000’<br />

Sp. z o.o, Mazańcowice 57, 49-391 MAZAŃCOWICE<br />

Bielski/Jasienica<br />

Production capacity<br />

(eggs/year)<br />

(1 000)<br />

9 500<br />

Transitional measures only<br />

apply to the cages installed<br />

in 1994<br />

1 500<br />

2 500<br />

2 700<br />

680<br />

8 000<br />

3 600<br />

2 950<br />

18 000<br />

7 625<br />

72 000<br />

50 000<br />

30 000<br />

6 264<br />

12 600


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1487<br />

No<br />

Name of the establishment<br />

County/Gmina<br />

29 ‘BIOS’ Sp. jawna Krystyna Kachel<br />

ul. Droniowiczki 12, 47-700 LUBLINIEC/Lubliniec<br />

30 ‘EKOFERM’<br />

Sp. cywilna, ul. Lompy 5, 42-287 LUBSZA<br />

Lubliniecki/Woz´niki<br />

31 Ireneusz Ba˛belek<br />

ul. Nowotomyska 35, 64-310 LWÓWEK<br />

Nowy/Tomys´l<br />

32 ‘OVA’ Sp. z o. o. Antoni Ma˛dry<br />

ul. Głuszyna 135, 61-630 POZNAŃ<br />

Poznański/Poznań<br />

33 Grzegorz Mrozek<br />

Nowe Tłoki 13 a<br />

Wolsztyn /Wolsztyn<br />

34 Henryk Łyczewski<br />

Z˙odyń, ul. Spacerowa 27, 64-212 SIEDLEC<br />

Wolsztyn/Siedlec<br />

35 Gabriela Szymkowiak<br />

De˛bno, ul. Czeres´niowa,<br />

62-060 DE˛BIENKO<br />

Poznański Ste˛szew<br />

36 Zofia i Jerzy Sokołowscy<br />

Rostarzewo, ul. Słowackiego 20/5, 64-200 WOLSZTYN<br />

Grodzisk /Wielkopolski Rakoniewice<br />

37 Rolniczy Kombinat Spółdzielczy w Łubnicy Augustowo,<br />

64-050 WIELICHOWO<br />

Grodzisk Wielkopolski /Wielichowo<br />

38 Barbara Nowak<br />

Siedlec, ul. Szkolna<br />

Wolsztyn/Siedlec<br />

39 Jan i Gertruda Motylewscy<br />

Lewków, ul. Kwiatkowska 26,<br />

63-410 OSTRÓW WLKP/Ostrów Wielkopolski<br />

40 Krystyna i Zygmunt Sztukowscy<br />

Wtórek, ul. Zielona 17,<br />

63-400 OSTRÓW WLKP./Ostrów Wielkopolski<br />

41 Józef Wojtyński<br />

ul. Wypoczynkowa 40, 64-300 NOWY TOMYS´ L/Nowy<br />

Tomys´l<br />

42 Waldemar Łaz´niak<br />

Przedzeń 31, 62-834 CEKÓW<br />

Kalisz/Ceków Kolonia<br />

43 Opolskie Zakłady Drobiarskie Continental Grain<br />

Company S. A.<br />

ul. Siedemsetlecia 23,<br />

49-100 NIEMODLIN<br />

44 Anna S´ liwa Osłonin<br />

ul. Parkowa 14,<br />

64-234 PRZEMET<br />

Production capacity<br />

(eggs/year)<br />

(1 000)<br />

25 000<br />

8 000<br />

16 934<br />

31 000<br />

6 000<br />

14 208<br />

11 000<br />

6 148<br />

12 000<br />

900<br />

6 250<br />

9 000<br />

350<br />

5 600<br />

110 000<br />

6 000


Datum<br />

veljavnosti<br />

Ime zdravila<br />

Appendix A<br />

referred to in Chapter 1 of Annex XIII (*)<br />

Lists as provided by Slovenia in one language of pharmaceutical products for which a marketing authorisation issued<br />

under Slovenian law prior to the date of accession shall remain valid until it is renewed in compliance with the acquis or<br />

until 31 December 2007, whichever is the earlier.<br />

Mention on this list does not prejudge whether or not the pharmaceutical product in question has a marketing<br />

authorisation in compliance with the acquis.<br />

List 1: Data on the Envisaged Necessary Renewals of Marketing Authorisations<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

11. 2. 2003 5 — NOK drazˇeji 50 mg nitroksolin 50 × 50 mg G04AG06 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

19. 3. 2004 ABAKTAL injekcije 400 mg/5 ml pefloksacin zlozˇenka z 10 ampulami po 5 ml<br />

raztopine<br />

J01MA03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

19. 3. 2004 ABAKTAL injekcije 400 mg/5 ml pefloksacin zlozˇenka s 5 ampulami po 5 ml raztopine J01MA03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

19. 3. 2004 ABAKTAL tablete 400 mg pefloksacin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

19. 3. 2004 ABAKTAL tablete 400 mg pefloksacin zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

27. 6. 2005 ACCOLATE zafirlukast zlozˇenka z 28 tabletami po 20 mg<br />

(2 × 14 tablet v pretisnem omotu)<br />

27. 6. 2005 ACCOLATE zafirlukast zlozˇenka s 56 tabletami po 20 mg<br />

(4 × 14 tablet v pretisnem omotu)<br />

J01MA03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01MA03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

R03DC01 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

R03DC01 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

19. 3. 2004 ACLOVIR mazilo 5% aciklovir zlozˇenka s tubo po 5 g mazila D06BB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

19. 3. 2004 ACLOVIR mazilo za oko 3% aciklovir zlozˇenka s tubo po 4,5 g mazila S01AD03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 7. 2002 ACTILYSE alteplaza 1 injekcijska steklenička po 20 mg praška<br />

in 1 steklenička po 20 ml vode za<br />

injekcije<br />

7. 7. 2002 ACTILYSE alteplaza 1 injekcijska steklenička po 50 mg praška<br />

in 1 steklenička po 50 ml vode za<br />

injekcije<br />

19. 3. 2004 ACTIVELLE estradiol zlozˇenka s plastičnim vsebnikom v obliki<br />

koluta z 28 tabletami (koledarsko<br />

pakiranje)<br />

(1 tableta vsebuje 0,5 mg<br />

noretisteronacetata in 1 mg estradiola)<br />

___________<br />

(*) For the text of Annex XIII see OJ L 236, 23.9.2003, p. 906.<br />

B01AD02 Boehringer Ingelheim<br />

International GmbH,<br />

B01AD02 Boehringer Ingelheim<br />

International GmbH,<br />

G03FA01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Ingelheim am Rhein Nemčija<br />

Ingelheim am Rhein Nemčija<br />

Danska<br />

1488 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

30. 5. 2002 ACTRAPID PENFILL 3 ml insulin, človeški,<br />

biosintetični<br />

7. 3. 2002 ACTRAPID NOVOLET insulin, človeški,<br />

biosintetični<br />

7. 3. 2002 ACTRAPID NOVOLET insulin, človeški,<br />

biosintetični<br />

zlozˇenka s 5 karpulami po 3 ml<br />

raztopine<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

5 napolnjenih injekcijskih brizg v obliki<br />

peresa NovoLet po 3 ml raztopine<br />

5 napolnjenih injekcijskih brizg v obliki<br />

peresa NovoLet po 1,5 ml raztopine<br />

A10AB01 Pliva d.d. Zagreb v<br />

sodelovanju z Novo Nordisk<br />

A/S<br />

A10AB01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10AB01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

2. 4. 2003 ACYNORM FORTE pepsin in kisline 30 tablet A09AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

24. 6. 2004 AD3 retinol<br />

(vitamin A)<br />

zlozˇenka s stekleničko (z zaporko s<br />

kapalko) po 15 ml emulzije (6000 I.E.<br />

vitamina A in 2000 I.E. vitamina D/ml)<br />

A11CB KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

sodelovanju s Knoll<br />

AG, Ludwigshafen,<br />

Nemčija<br />

7. 7. 2002 ADALAT kapsule nifedipin 50 × 10 mg C08CA05 Bayer Pharma d.o.o. Slovenija<br />

12. 7. 2004 ADALAT OROS 20 nifedipin zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

C08CA05 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

10. 11. 2002 ADALAT OROS 30 nifedipin 28 × 30 mg C08CA05 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

10. 11. 2002 ADALAT OROS 60 nifedipin 28 × 60 mg C08CA05 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

19. 3. 2004 ADAVIN drazˇeji 10 mg nicergolin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

19. 3. 2004 ADAVIN injekcije 4 mg nicergolin zlozˇenka s 5 vialami s praškom in<br />

5 ampulami topila<br />

19. 3. 2004 ADDAMEL N (kombinacije<br />

elektrolitov z<br />

drugimi<br />

pripravki)<br />

zlozˇenka z 20 plastičnimi ampulami po<br />

10 ml koncentrata<br />

C04AE02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

C04AE02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

B05XA31 Fresenius Kabi Halden ANS,<br />

Norveška za Fresenius<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

Danska<br />

Danska<br />

Danska<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Kabi AB, Švedska/<br />

Fresenius Kabi<br />

Deutschland Gmbh<br />

9. 7. 2003 ADIPEX RETARD fentermin 30 × 15 mg A08AA01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

9. 7. 2003 ADIPEX RETARD fentermin 100 × 15 mg A08AA01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

24. 6. 2004 ADRIBLASTINA PFS 10 mg doksorubicin zlozˇenka z eno vialo po 5 ml raztopine L01DB01 Pharmacia & Upjohn S.p.A.,<br />

Nerviano, Italija za<br />

24. 6. 2004 ADRIBLASTINA PFS 50 mg doksorubicin zlozˇenka z eno vialo po 25 ml raztopine L01DB01 Pharmacia & Upjohn S.p.A.,<br />

Nerviano, Italija za<br />

16. 12. 2002 ADSORBIRANO CEPIVO PROTI<br />

DAVICI<br />

davični anatoksin<br />

(toksoid)<br />

23. 10. 2003 ADUMBRAN oksazepam zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

ampula po 0,5 ml (2 I.E./0,5 ml) J07AF01 Chiron Behring GmbH &<br />

Co., Marburg<br />

N05BA04 Boehringer Ingelheim<br />

Pharma KG, Nemčija za<br />

Pharmacio & Upjohn<br />

S.A., Luxemburg<br />

Pharmacio & Upjohn<br />

S.A., Luxemburg<br />

Boehringer Ingelheim<br />

International GmbH<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1489


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

20. 9. 2004 AFLODERM krema alklometazon zlozˇenka s tubo po 20 g kreme D07AB10 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

20. 9. 2004 AFLODERM krema alklometazon zlozˇenka s tubo po 40 g kreme D07AB10 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

20. 9. 2004 AFLODERM mazilo alklometazon zlozˇenka s tubo po 40 g mazila D07AB10 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

20. 9. 2004 AFLODERM mazilo alklometazon zlozˇenka s tubo po 20 g mazila D07AB10 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

4. 1. 2004 AGGRASTAT tirofiban škatla s steklenim vsebnikom po 50 ml<br />

koncentrata (0,25 mg/ml)<br />

B01AC17 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

10. 11. 2002 AGLURAB 850 metformin 36 × 850 mg A10BA02 Medis d.o.o., v sodelovanju z<br />

GEA Farmaceutik<br />

4. 1. 2004 ALATAN tablete metildopa<br />

(levosučna oblika)<br />

škatla z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

20. 12. 2001 ALBOTHYL koncentrat polikrezulen steklenička po 25 ml koncentrata<br />

(360mg/1g)<br />

C02LB01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

G01AX03 Byk Gulden Lomberg<br />

Chemische Fabrik GmbH,<br />

20. 12. 2001 ALBOTHYL vaginalna globula polikrezulen 6 × 90mg G01AX03 Byk Gulden Lomberg<br />

Chemische Fabrik GmbH,<br />

12. 7. 2004 ALCAINE 0,5% proksimetakain zlozˇenka s kapalno plastenko po 15 ml<br />

raztopine<br />

1. 10. 2004 ALDACTONE kapsule 100 mg spironolakton zlozˇenka z 20 kapsulami (2 × 10 kapsul<br />

v pretisnem omotu)<br />

1. 10. 2004 ALDACTONE oblozˇene tablete<br />

25 mg<br />

1. 10. 2004 ALDACTONE oblozˇene tablete<br />

50 mg<br />

spironolakton zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

spironolakton zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

S01HA04 S.A. Alcon-Couvreur N.V.,<br />

Puurs, Belgija za Alcon<br />

C03DA01 Roche Diagnostics GmbH,<br />

Mannheim, Nemčija za<br />

C03DA01 Roche Diagnostics GmbH,<br />

Mannheim, Nemčija za<br />

C03DA01 Roche Diagnostics GmbH,<br />

Mannheim, Nemčija za<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

Fabrik, Danska<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

d.d., Ljubljana Slovenija<br />

Konstanz Nemčija<br />

Konstanz Nemčija<br />

Pharmaceuticals Ltd.,<br />

Hünenberg, Švica<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

24. 6. 2004 ALDIZEM tablete 60 mg diltiazem zlozˇenka s stekleničko po 30 tablet C08DB01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

24. 6. 2004 ALDIZEM tablete 90 mg diltiazem zlozˇenka s stekleničko po 30 tablet C08DB01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

1. 10. 2004 ALKADIL tablete 25 mg kaptopril zlozˇenka s stekleničko po 40 tablet C09AA01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

1. 10. 2004 ALKADIL tablete 50 mg kaptopril zlozˇenka s stekleničko po 40 tablet C09AA01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

7. 7. 2002 ALKERAN tablete 2 mg melfalan 25 × 2 mg L01AA03 Glaxo Wellcome Operations,<br />

Greenford<br />

Velika<br />

Britanija<br />

1490 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

7. 7. 2002 ALKERAN tablete 5 mg melfalan 25 × 5 mg L01AA03 Glaxo Wellcome Operations,<br />

Greenford<br />

7. 5. 2004 ALLERGODIL azelastin zlozˇenka s steklenim vsebnikom (z<br />

odmernim ventilom) po 10 ml raztopine<br />

(0,14 mg/odmerek)<br />

R01AC03 Asta Medica AG, Frankfurt<br />

am Main, Nemčija, za<br />

Asta Medica AG,<br />

Dresden<br />

28. 6. 2001 ALOMIDE kapljice za oko lodoksamid plastenka po 5 ml (1mg/1ml) S01GX05 ALCON Pharmaceuticals Ltd. Švica<br />

28. 6. 2001 ALOMIDE kapljice za oko lodoksamid plastenka po 15 ml (1mg/1ml) S01GX05 ALCON Pharmaceuticals Ltd. Švica<br />

7. 12. 2003 ALOPURINOL tablete alopurinol škatla s plastičnim vsebnikom po 100 M04AA01 Belupo, zdravila in<br />

Hrvaška<br />

tablet (100 × 100 mg)<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

9. 7. 2003 ALPHA D3 1 µg alfakalcidol 50 × 1 µg A11CC03 TEVA Pharmaceutical<br />

Industries Ltd.<br />

28. 6. 2001 ALPHA D3 0,25 mcg alfakalcidol 50 × 0,25 µg A11CC03 TEVA Pharmaceutical<br />

Industries Ltd.<br />

18. 1. 2001 ALPICORT prednizolon steklenička po 100 ml raztopine D07XA02 Dr. August Wolff & Co.,<br />

Arzneimittel, Bielefeld<br />

18. 1. 2001 ALPICORT F prednizolon steklenička po 100 ml D07XA02 Dr. August Wolff & Co.,<br />

Arzneimittel, Bielefeld<br />

4. 1. 2004 ALTRAMET injekcije<br />

200 mg/2 ml<br />

cimetidin škatla z 10 ampulami po 2 ml<br />

(200 mg/2 ml)<br />

4. 1. 2004 ALTRAMET tablete 200 mg cimetidin škatla s stekleničko po 35 tablet<br />

(35 × 200 mg)<br />

4. 1. 2004 ALTRAMET tablete 200 mg cimetidin škatla s stekleničko po 50 tablet<br />

(50 × 200 mg)<br />

4. 1. 2004 ALTRAMET tablete 300 mg cimetidin škatla s 40 tabletami po 300 mg (4 × 10<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 ALTRAMET tablete 400 mg cimetidin škatla z 20 tabletami po 400 mg (2 × 10<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 ALTRAMET tablete 400 mg cimetidin škatla s stekleničko po 50 tablet<br />

(50 × 400 mg)<br />

4. 1. 2004 ALTRAMET tablete 800 mg cimetidin škatla s 30 tabletami po 800 mg (3 × 10<br />

tablet v pretisnem omotu)<br />

A02BA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

A02BA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

A02BA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

A02BA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

A02BA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

A02BA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

A02BA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

18. 1. 2001 ALVOGYL pasta jod lonček po 12 g paste A01AD11 Specialites Septodont, Saint<br />

Maur des Fosses<br />

30. 5. 2002 AMARYL 1,0 glimepirid zlozˇenka s 30 tabletami A10BB12 Hoechst Marion Roussel<br />

S.p.A., Scoppito, Italija<br />

30. 5. 2002 AMARYL 2,0 glimepirid zlozˇenka s 30 tabletami A10BB12 Hoechst Marion Roussel<br />

S.p.A., Scoppito, Italija<br />

Velika<br />

Britanija<br />

Nemčija<br />

Izrael<br />

Izrael<br />

Nemčija<br />

Nemčija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Cedex Francija<br />

za Hoechst Marion<br />

Roussel GmbH, Dunaj,<br />

Avstrija<br />

za Hoechst Marion<br />

Roussel GmbH, Dunaj,<br />

Avstrija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1491


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

30. 5. 2002 AMARYL 3,0 glimepirid zlozˇenka s 30 tabletami A10BB12 Hoechst Marion Roussel<br />

S.p.A., Scoppito, Italija<br />

30. 5. 2002 AMARYL 4,0 glimepirid zlozˇenka s 30 tabletami A10BB12 Hoechst Marion Roussel<br />

S.p.A., Scoppito, Italija<br />

30. 5. 2002 AMARYL 6,0 glimepirid zlozˇenka s 30 tabletami A10BB12 Hoechst Marion Roussel<br />

S.p.A., Scoppito, Italija<br />

2. 6. 2005 AmBisome amfotericin zlozˇenka z 10 prebodnimi stekleničkami<br />

s praškom (50 mg amfotericina<br />

B-volumen stekleničke 30 ml ) in 10 filtri<br />

2. 6. 2005 AmBisome amfotericin zlozˇenka z 10 prebodnimi stekleničkami<br />

s praškom (volumen stekleničke 15 ml )<br />

in 10 filtri<br />

J02AA01 NeXstar Pharmaceuticals Ltd,<br />

Dublin, Irska za<br />

J02AA01 NeXstar Pharmaceuticals Ltd,<br />

Dublin, Irska za<br />

10. 11. 2002 AMINFLUORID GEL olaflur tuba po 25 g A01AA03 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

10. 11. 2002 AMINFLUORID RAZTOPINA 1% olaflur steklenička po 50 ml A01AA03 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

12. 3. 2004 AMINO-MEL NEPHRO aminokisline steklenica po 500 ml raztopine B05BA01 Fresenius Kabi Austria<br />

GmbH., Graz,<br />

12. 3. 2004 AMINO-MEL NEPHRO aminokisline steklenica po 250 ml raztopine B05BA01 Fresenius Kabi Austria<br />

GmbH., Graz,<br />

28. 6. 2001 AMINOMIX 1 (raztopine za<br />

parenteralno<br />

prehrano)<br />

28. 6. 2001 AMINOMIX 1 (raztopine za<br />

parenteralno<br />

prehrano)<br />

28. 6. 2001 AMINOMIX 1 (raztopine za<br />

parenteralno<br />

prehrano)<br />

28. 6. 2001 AMINOMIX 2 (raztopine za<br />

parenteralno<br />

prehrano)<br />

11. 2. 2003 AMINOPHYLLINUM injekcije za<br />

intramuskularno uporabo<br />

500 mg/2 ml<br />

11. 2. 2003 AMINOPHYLLINUM injekcije za<br />

intravensko uporabo<br />

250 mg/10 ml<br />

plastična vrečka po 1000 ml raztopine B05BA10 Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

plastična vrečka po 1500 ml raztopine B05BA10 Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

plastična vrečka po 2000 ml raztopine B05BA10 Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

plastična vrečka po 1000 ml raztopine B05BA10 Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

aminofilin 50 ampul po 2 ml (500 mg/2 ml) R03DA05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

aminofilin 50 ampul po 10 ml (250 mg/10 ml) R03DA05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

za Hoechst Marion<br />

Roussel GmbH, Dunaj,<br />

Avstrija<br />

za Hoechst Marion<br />

Roussel GmbH, Dunaj,<br />

Avstrija<br />

za Hoechst Marion<br />

Roussel GmbH, Dunaj,<br />

Avstrija<br />

NeXstar<br />

Pharmaceuticals Inc.,<br />

San Dimas, ZDA<br />

NeXstar<br />

Pharmaceuticals Inc.,<br />

San Dimas, ZDA<br />

Hrvaška<br />

Hrvaška<br />

Avstrija<br />

Avstrija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

1492 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

11. 2. 2003 AMINOPHYLLINUM retard<br />

tablete 350 mg<br />

11. 2. 2003 AMINOPHYLLINUM tablete<br />

100 mg<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

aminofilin 20 × 350 mg R03DA05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

aminofilin 50 × 100 mg R03DA05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 4. 2004 AMINOPLASMAL 10 % aminokisline steklenica po 500 ml raztopine B05BA01 B. Braun Melsungen AG,<br />

Melsungen<br />

9. 4. 2004 AMINOPLASMAL 10 % E aminokisline steklenica po 500 ml raztopine B05BA01 B. Braun Melsungen AG,<br />

Melsungen<br />

28. 6. 2001 AMINOSTERIL KE 10% aminokisline steklenica po 500 ml raztopine B05BA01 Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

25. 2. 2005 AMINOVENOES N-PAED 10% aminokisline steklenička po 100 ml raztopine B05BA01 Fresenius AG, Bad Homburg, Nemčija<br />

25. 2. 2005 AMINOVENOES N-PAED 6% aminokisline steklenička po 100 ml raztopine B05BA01 Fresenius AG, Bad Homburg, Nemčija<br />

19. 3. 2004 AMIOKORDIN amiodaron zlozˇenka s 60 tabletami po 200 mg<br />

(6 × 10 tablet v pretisnem omotu)<br />

C01BD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

7. 7. 2002 AMLOPIN tablete 10 mg amlodipin 20 × 10 mg C08CA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 7. 2002 AMLOPIN tablete 5 mg amlodipin 20 × 5 mg C08CA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 AMOKSICILIN kapljice<br />

100 mg/ml<br />

amoksicilin steklenička s praškom za pripravo 10 ml<br />

suspenzije (100 mg/ml)<br />

J01CA04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 AMOKSICILIN kapsule 250 mg amoksicilin 100 × 250 mg J01CA04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 AMOKSICILIN kapsule 250 mg amoksicilin 16 × 250 mg J01CA04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 AMOKSICILIN kapsule 250 mg amoksicilin 8 × 250 mg J01CA04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 AMOKSICILIN kapsule 375 mg amoksicilin 12 × 375 mg J01CA04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 AMOKSICILIN kapsule 375 mg amoksicilin 100 × 375 mg J01CA04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 AMOKSICILIN kapsule 375 mg amoksicilin 600 × 375 mg J01CA04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 AMOKSICILIN suspenzija<br />

125 mg/5 ml<br />

amoksicilin steklenička s praškom za pripravo 60 ml<br />

suspenzije (125 mg/5 ml)<br />

J01CA04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1493


Datum<br />

veljavnosti<br />

Ime zdravila<br />

7. 3. 2002 AMOKSIKLAV 2 × suspenzija<br />

457 mg/5 ml<br />

7. 3. 2002 AMOKSIKLAV 2 × SUSPENZIJA<br />

457mg/5ml<br />

7. 3. 2002 AMOKSIKLAV 2 × SUSPENZIJA<br />

457mg/5ml<br />

7. 3. 2002 AMOKSIKLAV 2 × SUSPENZIJA<br />

457mg/5ml<br />

30. 5. 2002 AMOKSIKLAV 2 × tablete<br />

1000 mg<br />

30. 5. 2002 AMOKSIKLAV 2 × tablete<br />

1000 mg<br />

30. 5. 2002 AMOKSIKLAV 2 × tablete<br />

1000 mg<br />

28. 6. 2001 AMOKSIKLAV 2 × tablete<br />

1000 mg<br />

28. 6. 2001 AMOKSIKLAV 2 × tablete<br />

1000 mg<br />

28. 6. 2001 AMOKSIKLAV 2 × tablete<br />

1000 mg<br />

30. 5. 2002 AMOKSIKLAV 2 × tablete<br />

625 mg<br />

30. 5. 2002 AMOKSIKLAV 2 × tablete<br />

625 mg<br />

30. 5. 2002 AMOKSIKLAV 2 × tablete<br />

625 mg<br />

17. 11. 2005 AMOKSIKLAV 2×,<br />

228,5 mg/5 ml peroralna<br />

suspenzija<br />

17. 11. 2005 AMOKSIKLAV 2×,<br />

228,5 mg/5 ml peroralna<br />

suspenzija<br />

17. 11. 2005 AMOKSIKLAV 2×,<br />

228,5 mg/5 ml peroralna<br />

suspenzija<br />

17. 11. 2005 AMOKSIKLAV 2×,<br />

228,5 mg/5 ml peroralna<br />

suspenzija<br />

mednarodno<br />

nelastniško ime<br />

amoksicilin škatla s stekleničko s praškom za<br />

pripravo 35 ml suspenzije (400 mg<br />

amoksicilina + 57 mg klavulanske<br />

kisline/5 ml)<br />

amoksicilin 1 steklenička za pripravo 140 ml<br />

suspenzije (457mg/5ml)<br />

amoksicilin 1 steklenička za pripravo 70 ml<br />

suspenzije (457mg/5ml)<br />

amoksicilin 1 steklenička za pripravo 50 ml<br />

suspenzije (457mg/5ml)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

amoksicilin zlozˇenka po 14 tablet v pretisnem omotu J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

amoksicilin zlozˇenka po 20 tablet v pretisnem omotu J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

amoksicilin zlozˇenka po 10 tablet v pretisnem omotu J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

amoksicilin zlozˇenka po 20 tablet v steklenički J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

amoksicilin zlozˇenka po 10 tablet v steklenički J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

amoksicilin zlozˇenka po 14 tablet v steklenički J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

amoksicilin zlozˇenka po 20 tablet v pretisnem omotu J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

amoksicilin zlozˇenka po 10 tablet v pretisnem omotu J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

amoksicilin zlozˇenka po 14 tablet v pretisnem omotu J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

amoksicilin zlozˇenka s stekleničko s praškom za<br />

pripravo 35 ml suspenzije in merico<br />

amoksicilin zlozˇenka s stekleničko s praškom za<br />

pripravo 140 ml suspenzije in merico<br />

amoksicilin zlozˇenka s stekleničko s praškom za<br />

pripravo 100 ml suspenzije in merico<br />

amoksicilin zlozˇenka s stekleničko s praškom za<br />

pripravo 70 ml suspenzije in merico<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

1494 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

4. 1. 2004 AMOKSIKLAV FORTE suspenzija<br />

312,5 mg/5 ml<br />

mednarodno<br />

nelastniško ime<br />

amoksicilin škatla s stekleničko po 25 g praška za<br />

pripravo 100 ml suspenzije (250 mg<br />

amoksicilina + 62,5 mg klavulanske<br />

kisline/5 ml)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 7. 2002 AMOKSIKLAV injekcije 1,2 g amoksicilin 5 vial po 1,2 g J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 7. 2002 AMOKSIKLAV injekcije 600 mg amoksicilin 5 vial po 600 mg J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

4. 1. 2004 AMOKSIKLAV kapljice<br />

62,5 mg/ml<br />

4. 1. 2004 AMOKSIKLAV suspenzija<br />

156,25 mg/5 ml<br />

amoksicilin škatla s stekleničko po 5 g praška za<br />

pripravo 20 ml suspenzije (50 mg<br />

amoksicilina + 12,5 mg klavulanske<br />

kisline/ml)<br />

amoksicilin škatla s stekleničko po 25 g praška za<br />

pripravo 100 ml suspenzije (125 mg<br />

amoksicilina + 31,25 mg klavulanske<br />

kisline/5 ml)<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 AMOKSIKLAV tablete 375 mg amoksicilin 20 × 375 mg J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 AMOKSIKLAV tablete 375 mg amoksicilin 21 × 375 mg J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 AMOKSIKLAV tablete 375 mg amoksicilin 15 × 375 mg J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

4. 1. 2004 AMOKSIKLAV tablete 625 mg amoksicilin škatla s stekleničko po 21 tablet (500 mg<br />

amoksicilina + 125 mg klavulanske<br />

kisline/tableto)<br />

4. 1. 2004 AMOKSIKLAV tablete 625 mg amoksicilin škatla s stekleničko po 15 tablet (500 mg<br />

amoksicilina + 125 mg klavulanske<br />

kisline/tableto)<br />

4. 1. 2004 AMOKSIKLAV tablete 625 mg amoksicilin škatla s stekleničko po 20 tablet (500 mg<br />

amoksicilina + 125 mg klavulanske<br />

kisline/tableto)<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01CR02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

12. 4. 2001 AMORON indapamid 30 × 2,5 mg C03BA11 Jaka- 80 AD- Radoviš,<br />

Farmacevtska, kozmetična<br />

12. 4. 2001 AMPHOCIL 100 mg amfotericin zlozˇenka z eno prebodno stekleničko s<br />

praškom<br />

12. 4. 2001 AMPHOCIL 50 mg amfotericin zlozˇenka z eno prebodno stekleničko s<br />

praškom<br />

J02AA01 Ben Venue Laboratories Inc.,<br />

Bedford, Ohio, ZDA za<br />

J02AA01 Ben Venue Laboratories Inc.,<br />

Bedford, Ohio, ZDA za<br />

2. 4. 2003 AMPICILIN ampicilin 50 vial po 500 mg J01CA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

2. 4. 2003 AMPICILIN ampicilin 100 × 250 mg J01CA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

in dietetična industrija,<br />

Radoviš<br />

Sequus Pharmaceuticals<br />

Inc., Menlo Park, CA,<br />

ZDA<br />

Sequus Pharmaceuticals<br />

Inc., Menlo Park, CA,<br />

ZDA<br />

Republika<br />

Makedonija<br />

Slovenija<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1495


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

2. 4. 2003 AMPICILIN ampicilin 100 × 500 mg J01CA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

2. 4. 2003 AMPICILIN ampicilin 16 × 500 mg J01CA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

2. 4. 2003 AMPICILIN ampicilin 50 vial po 1000 mg J01CA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

2. 4. 2003 AMPICILIN ampicilin steklenička s praškom za pripravo 100 ml<br />

suspenzije (250 mg/5ml)<br />

J01CA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

2. 4. 2003 AMPICILIN ampicilin 16 × 250 mg J01CA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

15. 2. 2004 AMYZOL injekcije 20 mg/2 ml amitriptilin zlozˇenka s 50 ampulami po 2 ml<br />

raztopine (20 mg/2 ml)<br />

15. 2. 2004 AMYZOL tablete 10 mg amitriptilin zlozˇenka s 100 tabletami po 10 mg<br />

(4 × 25 tablet v pretisnem omotu)<br />

15. 2. 2004 AMYZOL tablete 25 mg amitriptilin zlozˇenka s 30 tabletami po 25 mg<br />

(3 × 10 tablet v pretisnem omotu)<br />

N06AA09 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N06AA09 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N06AA09 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

16. 12. 2002 ANALGIN INJEKCIJE 1g/2 ml metamizol natrij 50 ampul po 2 ml (500 mg/ml) N02BB02 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

16. 12. 2002 ANALGIN INJEKCIJE 2,5 g/5ml metamizol natrij 50 ampul po 5 ml (500 mg/ml) N02BB02 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

16. 12. 2002 ANALGIN TABLETE metamizol natrij 10 × 500 mg N02BB02 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

16. 12. 2002 ANALGIN TABLETE metamizol natrij 500 × 500 mg N02BB02 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

7. 3. 2002 ANANDRON nilutamid 90 × 50 mg L02BB02 Hoechst/Laboratories<br />

Cassenne, Roussel Uclaf<br />

7. 3. 2002 ANATON tablete (20+12,5mg) enalapril 20 × (20+12,5mg) C09BA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

17. 12. 2004 ANDOL 100 acetilsalicilna<br />

kislina<br />

9. 4. 2004 ANDOL tablete 300 mg acetilsalicilna<br />

kislina<br />

9. 4. 2004 ANDOL tablete 300 mg acetilsalicilna<br />

kislina<br />

zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

zlozˇenka s 500 tabletami (50 × 10 tablet<br />

v pretisnem omotu)<br />

24. 12. 2004 ANDROCUR 10 ciproteron zlozˇenka s 45 tabletami (3 × 15 tablet v<br />

pretisnem omotu)<br />

20. 9. 2004 ANDROCUR 50 ciproteron zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

Group, Pariz Francija<br />

d.d., Ljubljana Slovenija<br />

B01AC06 Pliva d.d., Zagreb Hrvaška<br />

N02BA01 Pliva d.d., Zagreb Hrvaška<br />

N02BA01 Pliva d.d., Zagreb Hrvaška<br />

G03HA01 Schering AG, Berlin, Nemčija<br />

G03HA01 Schering AG, Berlin, Nemčija<br />

1496 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

11. 2. 2003 ANGAL S pršilo klorheksidin steklenička po 30 ml in plastični nastavek<br />

za pršenje<br />

4. 1. 2004 ANGISED gliceriltrinitrat škatla s stekleničko po 100 tablet (100 ×<br />

0,5 mg)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

R02AA05 LEK, d.d., Ljubljana, v<br />

sodelovanju z Laboratoria<br />

C01DA02 Glaxo Wellcome South<br />

Africa (Pty) Ltd., Juzˇna<br />

16. 12. 2002 ANSILAN KAPSULE 10 mg medazepam 25 × 10 mg N05BA03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

16. 12. 2002 ANSILAN MITE KAPSULE 5 mg medazepam 30 × 5 mg N05BA03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

12. 3. 2004 ANTAGOSAN 200 000 aprotinin zlozˇenka s 25 ampulami po 10 ml<br />

raztopine<br />

B02AB01 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

7. 7. 2002 ANTIDIAB glipizid 30 × 5 mg A10BB07 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 ANTOPAR gel 10 % benzoilperoksid tuba po 30 g (100 mg/g) D10AE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 ANTOPAR gel 5 % benzoilperoksid tuba po 30 g (50 mg/g) D10AE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 APAURIN diazepam 30 × 10 mg N05BA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

24. 6. 2005 APAURIN oblozˇene tablete 2 mg diazepam zlozˇenka s 30 tabletami (2 × 15 tablet v<br />

pretisnem omotu)<br />

24. 6. 2005 APAURIN oblozˇene tablete 5 mg diazepam zlozˇenka s 30 tabletami (2 × 15 tablet v<br />

pretisnem omotu)<br />

24. 6. 2005 APAURIN raztopina za injiciranje<br />

10 mg/2 ml<br />

diazepam zlozˇenka z 10 ampulami po 2 ml<br />

raztopine<br />

19. 3. 2004 APC paracetamol zlozˇenka s stekleničko po 10 tablet<br />

(1 tableta vsebuje 200 mg paracetamola,<br />

300 mg acetilsalicilne kisline in 60 mg<br />

kofeina)<br />

4. 1. 2004 APILEPSIN valprojska kislina škatla s stekleničko po 100 tablet<br />

(100 × 150 mg)<br />

4. 1. 2004 APILEPSIN valprojska kislina škatla s stekleničko po 100 tablet<br />

(100 × 300 mg)<br />

4. 1. 2004 APILEPSIN valprojska kislina škatla s stekleničko po 60 ml raztopine<br />

(300 mg/ml)<br />

24. 6. 2004 APROVEL tablete 150 mg irbesartan zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

24. 6. 2004 APROVEL tablete 300 mg irbesartan zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

N05BA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

N05BA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

N05BA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

N02BE51 GALEX- Proizvodnja in<br />

promet s farmacevtskimi in<br />

N03AG01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

N03AG01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

N03AG01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

C09CA04 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

C09CA04 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

Qualiphar N.V./S.A.<br />

Belgija<br />

Afrika, za Glaxo<br />

Wellcome Export Ltd.<br />

Velika<br />

Britanija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Frankfurt am Main Nemčija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

drugimi proizvodi, d.d. Slovenija<br />

sodelovanju s Sanofi,<br />

Francija<br />

sodelovanju s Sanofi,<br />

Francija<br />

sodelovanju s Sanofi,<br />

Francija<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

Slovenija<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1497


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

24. 6. 2004 APROVEL tablete 75 mg irbesartan zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

C09CA04 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

12. 4. 2001 AQUA PRO INJECTIONE voda za injekcije steklenica po 500 ml V07AB Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

7. 12. 2003 AQUA PRO INJECTIONE voda za injekcije plastenka po 1000 ml V07AB Zavod Republike Slovenije<br />

za transfuzijo krvi,<br />

7. 12. 2003 AQUA PRO INJECTIONE voda za injekcije plastenka po 500 ml V07AB Zavod Republike Slovenije<br />

za transfuzijo krvi,<br />

24. 6. 2004 AQUA PRO INJECTIONE voda za injekcije steklenica po 1000 ml V07AB Zavod Republike Slovenije<br />

za transfuzijo krvi,<br />

8. 11. 2001 AQUA REDESTILLATA voda za injekcije 50 ampul po 5 ml V07AB KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

8. 11. 2001 AQUA REDESTILLATA voda za injekcije 50 ampul po 2 ml V07AB KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

8. 11. 2001 AQUA REDESTILLATA voda za injekcije 50 ampul po 10 ml V07AB KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

30. 5. 2002 AQUAPHOR 10 ksipamid 30 × 10 mg C03BA10 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

30. 5. 2002 AQUAPHOR 20 ksipamid 30 × 20 mg C03BA10 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

30. 5. 2002 AQUAPHOR 40 ksipamid 30 × 40 mg C03BA10 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 AREDIA 15 mg pamidronska<br />

kislina<br />

3. 11. 2003 AREDIA 30 mg pamidronska<br />

kislina<br />

4 prebodne stekleničke po 15 mg in<br />

4 ampule po 5 ml vode za injekcije<br />

2 prebodni steklenički po 30 mg in<br />

2 ampuli po 10 ml vode za injekcije<br />

12. 11. 2004 ARFICIN 300 mg kapsule rifampicin zlozˇenka s plastičnim vsebnikom po<br />

16 kapsul<br />

12. 11. 2004 ARFICIN 300 mg kapsule rifampicin zlozˇenka s steklenim vsebnikom po<br />

100 kapsul<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

Farmacevtski oddelek-<br />

Pharmagena, Ljubljana<br />

Farmacevtski oddelek-<br />

Pharmagena, Ljubljana<br />

Farmacevtski oddelek-<br />

Pharmagena, Ljubljana<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

M05BA03 Novartis Pharma AG, Basel Švica<br />

M05BA03 Novartis Pharma AG, Basel Švica<br />

J04AB02 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

J04AB02 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

12. 1. 2003 ARICEPT donepezil 28 × 10 mg N06DA02 Pfizer S.A. Francija<br />

12. 1. 2003 ARICEPT donepezil 28 × 5 mg N06DA02 Pfizer S.A. Francija<br />

10. 11. 2002 ARIMIDEX anastrozol zlozˇenka z 28 tabletami (2 × 14 tablet v L02BG03 Zeneca Limited, Macclesfield,<br />

Velika<br />

pretisnem omotu, koledarsko pakiranje)<br />

Cheshire,<br />

Britanija<br />

12. 11. 2004 ASPIRIN 100 acetilsalicilna zlozˇenka s 30 tabletami (3 × 10 tablet v B01AC06 Bayer Pharma d.o.o.,<br />

v sodelovanju z Bayer<br />

kislina<br />

pretisnem omotu)<br />

Ljubljana, Slovenija<br />

AG, Nemčija<br />

Hrvaška<br />

Hrvaška<br />

1498 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

12. 11. 2004 ASPIRIN 100 acetilsalicilna<br />

kislina<br />

30. 5. 2002 ASPIRIN 500 acetilsalicilna<br />

kislina<br />

30. 5. 2002 ASPIRIN 500 acetilsalicilna<br />

kislina<br />

9. 7. 2003 ASPIRIN DIREKT acetilsalicilna<br />

kislina<br />

10. 11. 2002 ASPIRIN PROTECT 100 acetilsalicilna<br />

kislina<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

15. 2. 2005 ATACAND 16 mg kandesartan zlozˇenka s plastičnim vsebnikom po<br />

100 tablet<br />

15. 2. 2005 ATACAND 4 mg kandesartan zlozˇenka s plastičnim vsebnikom po<br />

100 tablet<br />

15. 2. 2005 ATACAND 8 mg kandesartan zlozˇenka s plastičnim vsebnikom po<br />

100 tablet<br />

11. 2. 2003 ATROVENT ipratropijev<br />

bromid<br />

11. 2. 2003 ATROVENT ipratropijev<br />

bromid<br />

9. 7. 2003 Atrovent Nasal 0,03% ipratropijev<br />

bromid<br />

B01AC06 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

50 × 500 mg N02BA01 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

20 × 500 mg N02BA01 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

10 × 500 mg N02BA01 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

30 × 100 mg B01AC06 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

pršilnik po 15 ml za 300 inhalacij<br />

(0,02 mg/inhalacijo)<br />

C09CA06 Astra Pharmaceutical<br />

Production AB za Astra<br />

C09CA06 Astra Pharmaceutical<br />

Production AB za Astra<br />

C09CA06 Astra Pharmaceutical<br />

Production AB za Astra<br />

R03BB01 Boehringer Ingelheim<br />

International GmbH,<br />

steklenička po 20 ml (261 µg/ml) R03BB01 Boehringer Ingelheim<br />

International GmbH,<br />

zlozˇenka z vsebnikom za pršilo s 15 ml<br />

raztopine (z zaporko z odmernim<br />

pršilnim ventilom — za 225 odmerkov)<br />

24. 6. 2004 AUGMENTIN amoksicilin zlozˇenka s stekleničko po 15 tablet<br />

(1 tableta vsebuje 500 mg amoksicilina in<br />

125 mg klavulanske kisline)<br />

24. 6. 2004 AUGMENTIN amoksicilin zlozˇenka s stekleničko s praškom za<br />

pripravo 100 ml suspenzije in odmerno<br />

zˇličko (5 ml suspenzije vsebuje 250 mg<br />

amoksicilina in 62,5 mg klavulanske<br />

kisline)<br />

29. 11. 2004 AUGMENTIN 2× filmsko<br />

oblozˇene tablete 1000 mg<br />

29. 11. 2004 AUGMENTIN 2× filmsko<br />

oblozˇene tablete 1000 mg<br />

29. 11. 2004 AUGMENTIN 2× filmsko<br />

oblozˇene tablete 625 mg<br />

29. 11. 2004 AUGMENTIN 2× filmsko<br />

oblozˇene tablete 625 mg<br />

amoksicilin zlozˇenka s 14 tabletami (2 × 7 tablet v<br />

pretisnem omotu)<br />

amoksicilin zlozˇenka z 10 tabletami (2 × 5 tablet v<br />

pretisnem omotu)<br />

amoksicilin zlozˇenka z 10 tabletami (2 × 5 tablet v<br />

pretisnem omotu)<br />

amoksicilin zlozˇenka s 14 tabletami (2 × 7 tablet v<br />

pretisnem omotu)<br />

R01AX03 Boehringer Ingelheim<br />

International GmbH,<br />

J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

Export & Trading AB,<br />

Södertälje<br />

Export & Trading AB,<br />

Södertälje<br />

Export & Trading AB,<br />

Södertälje<br />

Švedska<br />

Švedska<br />

Švedska<br />

Ingelheim am Rhein Nemčija<br />

Ingelheim am Rhein Nemčija<br />

Ingelheim am Rhein Nemčija<br />

sodelovanju s<br />

SmithKline Beecham<br />

sodelovanju s<br />

SmithKline Beecham<br />

sodelovanju s<br />

SmithKline Beecham<br />

sodelovanju s<br />

SmithKline Beecham<br />

sodelovanju s<br />

SmithKline Beecham<br />

sodelovanju s<br />

SmithKline Beecham<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1499


Datum<br />

veljavnosti<br />

Ime zdravila<br />

29. 11. 2004 AUGMENTIN 2× prašek za<br />

peroralno suspenzijo<br />

457 mg/5 ml<br />

29. 11. 2004 AUGMENTIN 2× prašek za<br />

peroralno suspenzijo<br />

457 mg/5 ml<br />

29. 11. 2004 AUGMENTIN 2× prašek za<br />

peroralno suspenzijo<br />

457 mg/5 ml<br />

mednarodno<br />

nelastniško ime<br />

amoksicilin zlozˇenka s stekleničko s praškom za<br />

pripravo 70 ml suspenzije in merilno<br />

zˇličko<br />

amoksicilin zlozˇenka s stekleničko s praškom za<br />

pripravo 140 ml suspenzije in merilno<br />

zˇličko<br />

amoksicilin zlozˇenka s stekleničko s praškom za<br />

pripravo 35 ml suspenzije in merilno<br />

zˇličko<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

11. 2. 2003 AUROPAN avranofin 30 × 3 mg M01CB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 AURORIX moklobemid 30 × 150 mg N06AG02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

23. 6. 2003 AURORIX 300 moklobemid 30 × 300 mg N06AG02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

28. 6. 2001 AURORIX tablete moklobemid 100 × 150 mg N06AG02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

28. 6. 2001 AVAMIGRAN tablete ergotamin zlozˇenka z 20 tabletami N02CA52 Bosnalijek, Sarajevo, v<br />

sodelovanju z ASTA<br />

5. 6. 2005 AVELOX 400 mg moksifloksacin zlozˇenka z 10 tabletami (2 × 5 tablet v<br />

pretisnem omotu)<br />

5. 6. 2005 AVELOX 400 mg moksifloksacin zlozˇenka s 5 tabletami (1 × 5 tablet v<br />

pretisnem omotu)<br />

29. 11. 2004 AVONEX interferon<br />

beta-1a,<br />

rekombinantni<br />

zlozˇenka s štirimi kompleti (en komplet<br />

je za pripravo enega odmerka in vsebuje:<br />

1 vialo s praškom, 1 napolnjeno<br />

injekcijsko brizgo po 1 ml topila in<br />

2 injekcijski igli)<br />

J01MA14 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

J01MA14 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

L03AB07 Biogen B.V., Amsterdam,<br />

Nizozemska za Schering —<br />

9. 7. 2003 AVOXIN fluvoksamin 16 × 100 mg N06AB08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

30. 5. 2002 B-COMPLEX drazˇeji vitamini<br />

kompleksa B<br />

30. 5. 2002 B-COMPLEX drazˇeji vitamini<br />

kompleksa B<br />

30. 5. 2002 B-COMPLEX zrnca vitamini<br />

kompleksa B<br />

27. 11. 2005 BACTIFLOX 250 mg ciprofloksacin zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

27. 11. 2005 BACTIFLOX 500 mg ciprofloksacin zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

zlozˇenka po 30 oblozˇenih tablet A11EA KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

pločevinka po 1000 oblozˇenih tablet A11EA KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

vrečka po 70 g A11EA KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01MA02 MEPHA Lda, Venda Nova,<br />

Amadora, Portugalska za<br />

J01MA02 MEPHA Lda, Venda Nova,<br />

Amadora, Portugalska za<br />

sodelovanju s<br />

SmithKline Beecham<br />

sodelovanju s<br />

SmithKline Beecham<br />

sodelovanju s<br />

SmithKline Beecham<br />

Pharma AG, Frankfurt/<br />

M<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

Plough Central East<br />

AG, Luzern<br />

MEPHA Ltd., Aesch,<br />

Švica<br />

MEPHA Ltd., Aesch,<br />

Švica<br />

Slovenija<br />

Švica<br />

Švica<br />

Švica<br />

Nemčija<br />

Švica<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

1500 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

27. 11. 2005 BACTIFLOX 750 mg ciprofloksacin zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

12. 1. 2003 BALUDON acetilsalicilna<br />

kislina<br />

30. 5. 2002 BARALGIN M injekcije<br />

500 mg/ml<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

J01MA02 MEPHA Lda, Venda Nova,<br />

Amadora, Portugalska za<br />

30 tablet po 500 mg B01AC06 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

metamizol natrij zlozˇenka s 5 ampulami po 5 ml raztopine N02BB02 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

Frankfurt,<br />

30. 5. 2002 BARALGIN M tablete metamizol natrij zlozˇenka z 20 tabletami (20 × 500 mg) N02BB02 Hoechst Marion Roussel<br />

S.p.A., Scoppito, Italija<br />

2. 4. 2003 BARIZIN drazˇeji 20 mg nikardipin 50 × 20 mg C08CA04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

18. 1. 2001 BATRAFEN LAK ZA NOHTE ciklopiroks steklenička po 6 g zdravilnega laka za<br />

nohte<br />

18. 1. 2001 BATRAFEN VAGINALNA<br />

KREMA<br />

20. 12. 2001 BCG CEPIVO proti tuberkulozi cepivo proti<br />

tuberkulozi z<br />

oslabljenimi<br />

bakterijam<br />

20. 12. 2001 BCG CEPIVO proti tuberkulozi cepivo proti<br />

tuberkulozi z<br />

oslabljenimi<br />

bakterijam<br />

MEPHA Ltd., Aesch,<br />

Švica<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

Nemčija / Hoechst<br />

Marion Roussel GmbH,<br />

Dunaj<br />

za Hoechst Marion<br />

Roussel GmbH, Dunaj,<br />

Avstrija<br />

Avstrija<br />

d.d., Ljubljana Slovenija<br />

D01AE14 Hoechst AG, Frankfurt, Nemčija<br />

ciklopiroks tuba po 40 g kreme + 6 aplikatorjev G01AX12 Hoechst AG, Frankfurt, Nemčija<br />

10 stekleničk z liofilizatom in 10 ampul<br />

po 1 ml vode za injekcije<br />

1 steklenička z liofilizatom in 1 ampula<br />

po 1 ml vode za injekcije<br />

18. 12. 2003 BECLOFORTE pršilnik beklometazon zlozˇenka z vsebnikom s suspenzijo z<br />

zaporko z odmernim ventilom in<br />

ustnikom (za 200 odmerkov)<br />

12. 3. 2004 BECONASE pršilo za nos beklometazon zlozˇenka s plastenko s suspenzijo za 200<br />

odmerkov (plastenka z zaporko z<br />

odmerno črpalko in nosnikom)<br />

21. 5. 2004 BECOTIDE pršilnik beklometazon zlozˇenka s kovinskim vsebnikom (z<br />

zaporko z odmernim ventilom) s<br />

suspenzijo za 200 odmerkov<br />

4. 12. 2001 BEGRIVAC 2000/2001 cepivo proti gripi<br />

z inaktiviranimi<br />

virusi<br />

7. 7. 2002 BEGRIVAC 96/97 prečiščen antigen<br />

virusa influence<br />

zlozˇenka z eno napolnjeno injekcijsko<br />

brizgo z iglo po 0,5 ml suspenzije<br />

v naprej napolnjena brizga z iglo po<br />

0,5 ml cepiva<br />

J07AN01 Pasteur Merieux Serums &<br />

Vaccins, Lyon<br />

J07AN01 Pasteur Merieux Serums &<br />

Vaccins, Lyon<br />

R03BA01 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

R01AD01 Glaxo Wellcome S.A.,<br />

Aranda de Duero, Španija, za<br />

R03BA01 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

J07BB01 Chiron Behring GmbH &<br />

Co., Marburg<br />

12. 11. 2004 BELODERM krema betametazon zlozˇenka s tubo po 15 g kreme D07AC01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Francija<br />

Francija<br />

Nemčija<br />

J07BB02 Behringwerke AG Nemčija<br />

Hrvaška<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1501


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

12. 11. 2004 BELODERM krema betametazon zlozˇenka s tubo po 100 g kreme D07AC01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

12. 11. 2004 BELODERM krema betametazon zlozˇenka s tubo po 30 g kreme D07AC01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

12. 11. 2004 BELODERM mazilo betametazon zlozˇenka s tubo po 30 g mazila D07AC01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

12. 11. 2004 BELODERM mazilo betametazon zlozˇenka s tubo po 100 g mazila D07AC01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

12. 11. 2004 BELODERM mazilo betametazon zlozˇenka s tubo po 15 g mazila D07AC01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

12. 11. 2004 BELOSALIC LOSION betametazon zlozˇenka s plastenko po 100 ml<br />

raztopine<br />

D07XC01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

12. 11. 2004 BELOSALIC LOSION betametazon zlozˇenka s plastenko po 50 ml raztopine D07XC01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

12. 11. 2004 BELOSALIC MAZILO betametazon zlozˇenka s tubo po 30 g mazila D07XC01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

18. 1. 2001 BENIL 0,5 % nafazolin steklenička po 10 ml (0,5mg/1ml) R01AA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

18. 1. 2001 BENIL 1 % nafazolin steklenička po 10 ml (1mg/1ml) R01AA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 BERIATE P 1000 koagulacijski<br />

faktor VIII<br />

3. 11. 2003 BERIATE P 250 koagulacijski<br />

faktor VIII<br />

3. 11. 2003 BERIATE P 500 koagulacijski<br />

faktor VIII<br />

viala s praškom (1000 I.E.), viala po<br />

10 ml vode za injekcije, set za pripravo<br />

raztopine, filter in injekcijska brizga<br />

viala s praškom (250 I.E.), viala po 2,5 ml<br />

vode za injekcije, set za pripravo<br />

raztopine, filter in injekcijska brizga<br />

viala s praškom (500 I.E.), viala po 5 ml<br />

vode za injekcije, set za pripravo<br />

raztopine, filter in injekcijska brizga<br />

B02BD02 Centeon Pharma GmbH,<br />

Marburg<br />

B02BD02 Centeon Pharma GmbH,<br />

Marburg<br />

B02BD02 Centeon Pharma GmbH,<br />

Marburg<br />

30. 5. 2002 BERIPLAST P (tkivni adhezivi) Beriplast P set po 3 ml V03AK Hoechst AG, Frankfurt, Nemčija<br />

30. 5. 2002 BERIPLAST P (tkivni adhezivi) Beriplast P set po 1 ml V03AK Hoechst AG, Frankfurt, Nemčija<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Slovenija<br />

Slovenija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

1502 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

4. 1. 2004 BERIPLAST P COMBI SET (tkivni adhezivi) Set 1 ml: škatla s Combi SET I in Combi<br />

SET II. Combi SET I: steklenička s<br />

fibrinogenom in steklenička z raztopino<br />

aprotinina; Combi Set II: steklenička s<br />

trombinom in steklenička z raztopino<br />

kalcijevega klorida; škatla s setom za<br />

aplikacijo<br />

4. 1. 2004 BERIPLAST P COMBI SET (tkivni adhezivi) Set 3 ml: škatla s Combi SET I in Combi<br />

SET II. Combi SET I: steklenička s<br />

fibrinogenom in steklenička z raztopino<br />

aprotinina; Combi Set II: steklenička s<br />

trombinom in steklenička z raztopino<br />

kalcijevega klorida; škatla s setom za<br />

aplikacijo<br />

12. 1. 2003 BERIPLEX P/N 250 I.E. koagulacijski<br />

faktor IX<br />

12. 1. 2003 BERIPLEX P/N 500 I.E. koagulacijski<br />

faktor IX<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

viala s praškom ( 250 I.E.), viala po 10 ml<br />

vode za injekcije in set za pripravo<br />

raztopine<br />

viala s praškom ( 500 I.E.), viala po 10 ml<br />

vode za injekcije in set za pripravo<br />

raztopine<br />

V03AK Centeon Pharma GmbH,<br />

Marburg<br />

V03AK Centeon Pharma GmbH,<br />

Marburg<br />

B02BD01 Centeon Pharma GmbH,<br />

Marburg<br />

B02BD01 Centeon Pharma GmbH,<br />

Marburg<br />

20. 12. 2001 BERODUAL aerosol za inhalacijo fenoterol pršilnik po 15ml (300 inhalacij) R03AK03 Boehringer Ingelheim<br />

International GmbH,<br />

20. 12. 2001 BERODUAL raztopina za<br />

inhalacijo<br />

fenoterol steklenička po 20ml R03AK03 Boehringer Ingelheim<br />

International GmbH,<br />

7. 7. 2002 BEROTEC fenoterol zlozˇenka z vsebnikom s suspenzijo — z<br />

odmernim ventilom in nastavkom za<br />

inhaliranje (za 200 odmerkov)<br />

12. 7. 2004 BETADINE raztopina 10% povidon-jod zlozˇenka s plastenko po 100 ml<br />

raztopine<br />

12. 7. 2004 BETADINE raztopina 10% povidon-jod zlozˇenka s plastenko po 1000 ml<br />

raztopine<br />

12. 7. 2004 BETADINE raztopina za grgranje<br />

1%<br />

12. 7. 2004 BETADINE raztopina za čiščenje<br />

in dezinfekcijo kozˇe 7,5%<br />

12. 7. 2004 BETADINE raztopina za čiščenje<br />

in dezinfekcijo kozˇe 7,5%<br />

povidon-jod zlozˇenka s plastenko po 100 ml<br />

raztopine<br />

povidon-jod zlozˇenka s plastenko po 1000 ml<br />

raztopine<br />

povidon-jod zlozˇenka s plastenko po 100 ml<br />

raztopine<br />

R03AC04 Boehringer Ingelheim<br />

International GmbH,<br />

D08AG02 Alkaloid d.d., Skopje,<br />

Republika Makedonija v<br />

D08AG02 Alkaloid d.d., Skopje,<br />

Republika Makedonija v<br />

R02AA15 Alkaloid d.d., Skopje,<br />

Republika Makedonija v<br />

D08AG02 Alkaloid d.d., Skopje,<br />

Republika Makedonija v<br />

D08AG02 Alkaloid d.d., Skopje,<br />

Republika Makedonija v<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Ingelheim am Rhein Nemčija<br />

Ingelheim am Rhein Nemčija<br />

Ingelheim am Rhein Nemčija<br />

sodelovanju z<br />

Mundipharma AG,<br />

Basel, Švica<br />

sodelovanju z<br />

Mundipharma AG,<br />

Basel, Švica<br />

sodelovanju z<br />

Mundipharma AG,<br />

Basel, Švica<br />

sodelovanju z<br />

Mundipharma AG,<br />

Basel, Švica<br />

sodelovanju z<br />

Mundipharma AG,<br />

Basel, Švica<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1503


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

12. 7. 2004 BETADINE vagitoriji 200 mg povidon-jod zlozˇenka s 14 vaginalnimi globulami (2 ×<br />

7 globul v dvojnem traku)<br />

28. 6. 2001 BETAKLAV FORTE prašek za<br />

peroralno suspenzijo<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

G01AX11 Alkaloid d.d., Skopje,<br />

Republika Makedonija v<br />

amoksicilin steklenička za pripravo 100 ml suspenzije J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 BETAKLAV FORTE tablete amoksicilin 15 tablet J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 BETAKLAV prašek za peroralno<br />

suspenzijo<br />

amoksicilin steklenička za pripravo 100 ml suspenzije J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

sodelovanju z<br />

Mundipharma AG,<br />

Basel, Švica<br />

28. 6. 2001 BETAKLAV tablete amoksicilin 15 tablet J01CR02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

18. 1. 2001 BIOSOL AFB 145 natrijev<br />

hidrogenkarbonat<br />

3 vrečke po 3000 ml raztopine B05ZB Biosol S.p.A., Sondalo Italija<br />

7. 3. 2002 BISOLVON F bromheksin 50 × 16mg R05CB02 Boehringer Ingelheim<br />

International GmbH,<br />

Ingelheim am Rhein Nemčija<br />

28. 6. 2001 BISOLVON injekcije bromheksin zlozˇenka s 5 ampulami po 2 ml raztopine<br />

(4mg/2ml)<br />

R05CB02 Boehringer Ingelheim<br />

International GmbH,<br />

7. 3. 2002 BISOLVON sirup bromheksin zlozˇenka s stekleničko po 250 ml sirupa R05CB02 Boehringer Ingelheim France,<br />

Francija za Boehringer<br />

4. 1. 2004 BIVACYN dermalni prašek neomicin škatla s plastičnim vsebnikom po 50 g<br />

sterilnega praška (3500 IE neomicina +<br />

250 IE bacitracina/g)<br />

4. 1. 2004 BIVACYN dermalni prašek neomicin škatla s plastičnim vsebnikom po 5 g<br />

praška (3500 IE neomicina + 250 IE<br />

bacitracina/g)<br />

4. 1. 2004 BIVACYN dermalno pršilo neomicin škatla z vsebnikom (s pršilnim ventilom)<br />

po 150 ml pršila (165 000 IE neomicina<br />

+ 12 500 IE bacitracina/150 ml)<br />

4. 1. 2004 BIVACYN kapljice za oko in uho neomicin škatla z vialo s praškom za pripravo<br />

raztopine, vialo po 10 ml topila in<br />

nastavkom za kapljanje (3500 IE<br />

neomicina + 250 IE bacitracina/ml)<br />

4. 1. 2004 BIVACYN mazilo neomicin škatla s tubo po 30 g mazila (3500 IE<br />

neomicina + 500 IE bacitracina/g)<br />

4. 1. 2004 BIVACYN mazilo za oko neomicin škatla s tubo po 3,5 g mazila (3500 IE<br />

neomicina + 250 IE bacitracina/g)<br />

D06AX04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

D06AX04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

D06AX04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

S03AA30 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

D06AX04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

S01AA30 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 BLOXAN metoprolol 30 × 100 mg C07AB02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

20. 12. 2001 BONEFOS kapsule 400 mg klodronska kislina zlozˇenka s plastenko po 100 kapsul M05BA02 Leiras Oy, Turku, Finska, za<br />

Schering AG, Berlin,<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Ingelheim am Rhein Nemčija<br />

Ingelheim International,<br />

Ingelheim am Rhein<br />

Nemčija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Nemčija<br />

Slovenija<br />

1504 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

20. 12. 2001 BONEFOS koncentrat za pripravo<br />

raztopine za infundiranje<br />

mednarodno<br />

nelastniško ime<br />

klodronska kislina zlozˇenka s 5 ampulami po 5 ml<br />

koncentrata (300 mg/5 ml)<br />

7. 5. 2004 BONIFEN ibuprofen zlozˇenka z 10 tabletami po 200 mg<br />

(1 × 10 tablet v pretisnem omotu)<br />

7. 5. 2004 BONIFEN ibuprofen zlozˇenka z 20 tabletami po 200 mg<br />

(2 × 10 tablet v pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

M05BA02 Leiras Oy,Turku,Finska in/ali<br />

Schering GmbH und Co<br />

M01AE01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

M01AE01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

30. 5. 2002 BONIFEN gel ibuprofen tuba po 50 g (50mg/1g) M02AA13 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

2. 4. 2003 BRINERDIN reserpin 50 tablet C02LA51 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

18. 1. 2001 BROMERGON kapsule 5mg bromokriptin 30 × 5 mg N04BC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

18. 1. 2001 BROMERGON kapsule 5 mg bromokriptin 100 × 5 mg N04BC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 BROMERGON tablete 10 mg bromokriptin 30 × 10 mg N04BC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 BROMERGON tablete 2,5 mg bromokriptin 30 × 2,5 mg G02CB01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

24. 6. 2004 BRONCHO-MUNAL kapsule<br />

7mg<br />

24. 6. 2004 BRONCHO-MUNAL kapsule<br />

7mg<br />

24. 6. 2004 BRONCHO-MUNAL P kapsule<br />

3,5 mg<br />

24. 6. 2004 BRONCHO-MUNAL P kapsule<br />

3,5 mg<br />

(drugi pripravki<br />

za zdravljenje<br />

bolezni dihal-lizat<br />

bakterij)<br />

(drugi pripravki<br />

za zdravljenje<br />

bolezni dihal-lizat<br />

bakterij)<br />

(drugi pripravki<br />

za zdravljenje<br />

bolezni dihal-lizat<br />

bakterij)<br />

(drugi pripravki<br />

za zdravljenje<br />

bolezni dihal-lizat<br />

bakterij)<br />

zlozˇenka s 30 kapsulami (3 × 10 kapsul v<br />

pretisnem omotu )<br />

zlozˇenka z 10 kapsulami (1 × 10 kapsul<br />

v pretisnem omotu )<br />

zlozˇenka s 30 kapsulami (3 × 10 kapsul v<br />

pretisnem omotu )<br />

zlozˇenka z 10 kapsulami (1 × 10 kapsul<br />

v pretisnem omotu )<br />

R07AX LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

R07AX LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

R07AX LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

R07AX LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 BURINEX bumetanid 20 × 1 mg C03CA02 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

1. 10. 2004 CAFFETIN paracetamol zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

dvojnem traku)<br />

1. 10. 2004 CAFFETIN paracetamol zlozˇenka s 500 tabletami (50 × 10 tablet<br />

v dvojnem traku)<br />

Produktions KG,Jena,<br />

Nemčija za Schering<br />

AG,Berlin<br />

sodelovanju z Novartis<br />

Pharma Ltd., Švica<br />

Nemčija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Koppenhagen Danska<br />

N02BE51 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

N02BE51 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1505


Datum<br />

veljavnosti<br />

Ime zdravila<br />

2. 4. 2003 CALCII CARBONATIS<br />

CAPSULAE<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

kalcijev karbonat 100 × 500 mg A12AA04 Lekarna Ljubljana, PE<br />

Galenski laboratorij,<br />

20. 12. 2001 CALCIJEX 2µg kalcitriol 4 × 25 ampul po 1 ml (2µg/1ml) A11CC04 Abbott Laboratories, North<br />

Chicago, Illinois<br />

20. 12. 2001 CALCIJEX 1 µg kalcitriol 4 × 25 ampul po 1 ml (1µg/1ml) A11CC04 Abbott Laboratories, North<br />

Chicago, Illinois<br />

16. 12. 2002 CALCIUM-SANDOZ FORTE kalcijev laktat<br />

glukonat<br />

7. 5. 2004 CALGEL gel za dlesni lidokain zlozˇenka s tubo po 10 g gela (1 g gela<br />

vsebuje 3,3 mg lidokainijevega klorida in<br />

1 mg cetilpiridinijevega klorida)<br />

7. 5. 2004 CALPOL paracetamol zlozˇenka s stekleničko po 140 ml<br />

suspenzije in merilno zˇličko<br />

(120 mg/5 ml)<br />

7. 5. 2004 CALPOL 6 PLUS paracetamol zlozˇenka s steklenim vsebnikom po<br />

100 ml suspenzije in merilno zˇličko<br />

29. 11. 2004 CAMPTO 100 mg/5 ml<br />

koncentrat za pripravo raztopine<br />

za infundiranje<br />

29. 11. 2004 CAMPTO 40 mg/2 ml koncentrat<br />

za pripravo raztopine za<br />

infundiranje<br />

8. 11. 2001 CANIFUG raztopina klotrimazol pršilnik po 30 ml raztopine<br />

(850mg/100ml)<br />

20 tablet A12AA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

N01BB52 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

N02BE01 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

N02BE01 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

irinotekan zlozˇenka z 1 vialo po 5 ml koncentrata L01XX19 Rhone Poulenc Rorer, Velika<br />

Britanija za Bellon<br />

irinotekan zlozˇenka z 1 vialo po 2 ml koncentrata L01XX19 Rhone Poulenc Rorer, Velika<br />

Britanija za Bellon<br />

D01AC01 Dr. August Wolff & Co.,<br />

Arzneimittel, Bielefeld<br />

28. 6. 2001 CASODEX bikalutamid 28 × 50 mg L02BB03 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

19. 3. 2004 CATAPRESAN 150 klonidin zlozˇenka s 50 tabletami po 0,15 mg (5 X<br />

10 tablet v pretisnem omotu)<br />

29. 11. 2004 CATHEJELL lidocain uretralni gel lidokain zlozˇenka s 5 tubami po 12,5 g gela (5 ×<br />

1 tuba z aplikatorjem v pretisnem omotu)<br />

(100 g gela vsebuje 2 g lidokainijevega<br />

klorida in 0,05 g klorheksidinijevega<br />

diklorida)<br />

29. 11. 2004 CATHEJELL lidocain uretralni gel lidokain zlozˇenka s 25 tubami po 12,5 g gela (5 ×<br />

5 tub z aplikatorjem v pretisnem omotu)<br />

20. 12. 2001 CAVERJECT 20 µg alprostadil zlozˇenka z vialo po 20 µg alprostadila,<br />

injekcijsko brizgo po 1 ml vehikla,<br />

injekcijsko iglo in dvema krpicama<br />

prepojenima z alkoholom<br />

C02AC01 Boehringer Ingelheim<br />

Pharma KG, Nemčija za<br />

N01BB52 Pharmazeutische Fabrik<br />

Montavit Ges.m.b.H,<br />

N01BB52 Pharmazeutische Fabrik<br />

Montavit Ges.m.b.H,<br />

G04BE01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

Ljubljana Slovenija<br />

sodelovanju z Novartis<br />

Pharma Ltd., Švica<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Rhone Poulenc Rorer,<br />

Francija<br />

Rhone Poulenc Rorer,<br />

Francija<br />

Boehringer Ingelheim<br />

International GmbH<br />

ZDA<br />

ZDA<br />

Nemčija<br />

Velika<br />

Britanija<br />

Nemčija<br />

Absam/Tirolska Avstrija<br />

Absam/Tirolska Avstrija<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

1506 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

20. 12. 2001 CAVERJECT 10 µg alprostadil zlozˇenka z vialo po 10 µg alprostadila,<br />

injekcijsko brizgo po 1 ml vehikla,<br />

injekcijsko iglo in dvema krpicama<br />

prepojenima z alkoholom<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

G04BE01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

20. 12. 2001 CECLOR MR 375 mg cefaklor 10 × 375 mg J01DA08 Eli Lilly Italia S.p.A., Sesto<br />

Fiorentino,<br />

20. 12. 2001 CECLOR MR 500 mg cefaklor 10 × 500 mg J01DA08 Eli Lilly Italia S.p.A., Sesto<br />

Fiorentino,<br />

20. 12. 2001 CECLOR MR 750 mg cefaklor 10 × 750 mg (1 × 10 tablet v pretisnem<br />

omotu)<br />

J01DA08 Eli Lilly Italia S.p.A., Sesto<br />

Fiorentino,<br />

2. 4. 2003 CEFAMEZIN cefazolin viala po 1000 mg J01DA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

7. 5. 2004 CEFOBID cefoperazon zlozˇenka z eno vialo po 1 g cefoperazona J01DA32 Pfizer Ilaçlari A.S., Turčija, za<br />

Pfizer<br />

9. 7. 2003 CEFOTAKSIM injekcije 1g cefotaksim viala po 1 g J01DA10 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 CEFOTAKSIM injekcije 2 g cefotaksim viala po 2 g J01DA10 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

23. 6. 2003 CELLCEPT mikofenolna<br />

kislina<br />

23. 6. 2003 CELLCEPT mikofenolna<br />

kislina<br />

23. 6. 2003 CELLCEPT mikofenolna<br />

kislina<br />

150 × 500 mg L04AA06 Syntex Puerto Rico, Inc.,<br />

Humacao, Portoriko, za<br />

50 × 500 mg L04AA06 Syntex Puerto Rico, Inc.,<br />

Humacao, Portoriko, za<br />

100 × 250 mg L04AA06 Syntex Puerto Rico, Inc.,<br />

Humacao, Portoriko, za<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

sodelovanju s Fujisawa<br />

Pharmaceutical,<br />

Japonska<br />

International Inc., New<br />

York, ZDA<br />

Italija<br />

Italija<br />

Italija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

12. 4. 2001 CHLORAMPHENICOL 1% kloramfenikol tuba po 5g S01AA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

11. 2. 2003 CILAZIL TABLETE 0,5 mg cilazapril 30 × 0,5 mg C09AA08 Pliva d.d., Zagreb Hrvaška<br />

11. 2. 2003 CILAZIL TABLETE 1 mg cilazapril 30 × 1 mg C09AA08 Pliva d.d., Zagreb Hrvaška<br />

11. 2. 2003 CILAZIL TABLETE 2,5 mg cilazapril 30 × 2,5 mg C09AA08 Pliva d.d., Zagreb Hrvaška<br />

11. 2. 2003 CILAZIL TABLETE 5 mg cilazapril 30 × 5 mg C09AA08 Pliva d.d., Zagreb Hrvaška<br />

23. 10. 2003 CILEST norgestimat zlozˇenka z 21 tabletami (1 × 21 tablet v<br />

pretisnem omotu)<br />

G03AA11 Cilag AG, Schaffhausen, Švica<br />

23. 10. 2003 CILEST norgestimat zlozˇenka s 63 tabletami (3 × 21 tablet v<br />

pretisnem omotu)<br />

G03AA11 Cilag AG, Schaffhausen, Švica<br />

1. 10. 2004 CILOXAN ciprofloksacin zlozˇenka s kapalno plastenko po 5ml<br />

raztopine<br />

7. 5. 2004 CINARIZIN forte tablete 75 mg cinarizin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

S01AX13 S.A. Alcon-Couvreur N.V.,<br />

Puurs, Belgija za Alcon<br />

N07CA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Pharmaceuticals Ltd.,<br />

Hünenberg, Švica<br />

d.d., Ljubljana Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1507


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 5. 2004 CINARIZIN tablete 25 mg cinarizin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

7. 12. 2003 CIPRAMIL sterilni koncentrat za<br />

infuzijo 20 mg<br />

citalopram škatla s 5 ampulami po 0,5 ml<br />

(20 mg/0,5 ml)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

N07CA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N06AB04 H. Lundbeck A/S,<br />

Copenhagen-Valby,<br />

9. 7. 2003 CIPRAMIL tablete 20 mg citalopram 28 × 20 mg N06AB04 H. Lundbeck A/S,<br />

Copenhagen-Valby,<br />

30. 5. 2002 CIPRINOL ciprofloksacin zlozˇenka z 1 vialo po 50 ml raztopine<br />

(100mg/50ml)<br />

30. 5. 2002 CIPRINOL ciprofloksacin zlozˇenka z 1 vialo po 100 ml<br />

(200mg/100ml)<br />

20. 9. 2004 CIPRINOL ciprofloksacin zlozˇenka z 10 tabletami po 250 mg (1 ×<br />

10 tablet v pretisnem omotu)<br />

20. 9. 2004 CIPRINOL ciprofloksacin zlozˇenka z 10 tabletami po 500 mg (1 ×<br />

10 tablet v pretisnem omotu)<br />

20. 9. 2004 CIPRINOL ciprofloksacin zlozˇenka s 5 ampulami po 10 ml<br />

koncentrata (100 mg/10 ml)<br />

30. 5. 2002 CIPRINOL raztopina za<br />

intravensko infundiranje<br />

400 mg/200 ml<br />

J01MA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01MA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01MA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01MA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01MA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

ciprofloksacin zlozˇenka z eno vialo po 200 ml raztopine J01MA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 CIPROBAY 200 ciprofloksacin steklenička po 100 ml (200mg/100 ml) J01MA02 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

3. 11. 2003 CIPROBAY 250 ciprofloksacin 10 × 250 mg J01MA02 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

3. 11. 2003 CIPROBAY 400 ciprofloksacin steklenička po 200 ml (400mg/200 ml) J01MA02 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

3. 11. 2003 CIPROBAY 500 ciprofloksacin 10 × 500 mg J01MA02 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

3. 11. 2003 CIPROBAY 750 ciprofloksacin 10 × 750 mg J01MA02 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

3. 11. 2003 CIPROBAY suspenzija,<br />

10 g/100 ml<br />

3. 11. 2003 CIPROBAY suspenzija,<br />

5 g/100 ml<br />

ciprofloksacin steklenička po 17 g zrnc (10,7 g/17 g) in<br />

plastenka po 98,1 g topila za pripravo<br />

107 ml suspenzije (10 g/100 ml) in<br />

merilna zˇlička<br />

ciprofloksacin steklenička po 8,5 g zrnc (5,35 g/8,5 g) in<br />

plastenka po 106,1g topila za pripravo<br />

107 ml suspenzije (5 g/100 ml) in<br />

merilna zˇlička<br />

J01MA02 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

J01MA02 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

7. 7. 2002 CIPROBAY URO ciprofloksacin 6 × 100 mg J01MA02 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

d.d., Ljubljana Slovenija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

Danska<br />

Danska<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

1508 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

4. 1. 2004 CIPROXIN HC hidrokortizon zlozˇenka s stekleničko po 10 ml<br />

suspenzije in kapalko<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

S02CA03 Bayer Corporation,<br />

Myerstown, Pennsylvania,<br />

ZDA za<br />

3. 11. 2003 CITRIPAN paracetamol 10 vrečk po 5 g zrnc (500 mg/5 g) N02BE01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 CITRIPANČEK paracetamol 10 vrečk po 5 g zrnc (120 mg/5 g) N02BE01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

23. 10. 2003 CLAFORAN 1,0 cefotaksim 5 × zlozˇenka z 1 prebodno stekleničko s<br />

praškom<br />

23. 10. 2003 CLAFORAN 2,0 cefotaksim 5 × zlozˇenka z 1 prebodno stekleničko s<br />

praškom in ampulo po 10 ml vode za<br />

injekcije<br />

12. 7. 2004 CLARITINE loratadin zlozˇenka z 10 tabletami po 10 mg (1 ×<br />

10 tablet v pretisnem omotu)<br />

12. 7. 2004 CLARITINE loratadin zlozˇenka s 30 tabletami po 10 mg (3 ×<br />

10 tablet v pretisnem omotu)<br />

12. 7. 2004 CLARITINE loratadin zlozˇenka s stekleničko po 120 ml sirupa<br />

(1 mg/ml)<br />

29. 11. 2004 CLEXANE 100 mg/1 ml enoksaparin zlozˇenka z dvema napolnjenima<br />

injekcijskama brizgama po 1 ml<br />

raztopine<br />

29. 11. 2004 CLEXANE 20 mg/0,2 ml enoksaparin zlozˇenka z dvema napolnjenima<br />

injekcijskama brizgama po 0,2 ml<br />

raztopine<br />

29. 11. 2004 CLEXANE 40 mg/0,4 ml enoksaparin zlozˇenka z dvema napolnjenima<br />

injekcijskama brizgama po 0,4 ml<br />

raztopine<br />

29. 11. 2004 CLEXANE 60 mg/0,6 ml enoksaparin zlozˇenka z dvema napolnjenima<br />

injekcijskama brizgama po 0,6 ml<br />

raztopine<br />

29. 11. 2004 CLEXANE 80 mg/0,8 ml enoksaparin zlozˇenka z dvema napolnjenima<br />

injekcijskama brizgama po 0,8 ml<br />

raztopine<br />

9. 7. 2003 CLIMEN estradiol zlozˇenka z 21 tabletami (11 belih in 10<br />

rozˇnatih tablet)<br />

J01DA10 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

Frankfurt,<br />

J01DA10 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

Frankfurt,<br />

R06AX13 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

R06AX13 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

R06AX13 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

B01AB05 Rhone Poulenc Rorer<br />

Pharma Specialites, Francija<br />

B01AB05 Rhone Poulenc Rorer<br />

Pharma Specialites, Francija<br />

B01AB05 Rhone Poulenc Rorer<br />

Pharma Specialites, Francija<br />

B01AB05 Rhone Poulenc Rorer<br />

Pharma Specialites, Francija<br />

B01AB05 Rhone Poulenc Rorer<br />

Pharma Specialites, Francija<br />

G03HB01 Schering AG, Berlin, Nemčija<br />

ali Schering S.A.,<br />

Alcon Pharmaceuticals<br />

Ltd., Hünenberg, Švica<br />

Nemčija / Hoechst<br />

Marion Roussel GmbH,<br />

Dunaj<br />

Nemčija / Hoechst<br />

Marion Roussel GmbH,<br />

Dunaj<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

za Bellon Rhone<br />

Poulenc Rorer<br />

za Bellon Rhone<br />

Poulenc Rorer<br />

za Bellon Rhone<br />

Poulenc Rorer<br />

za Bellon Rhone<br />

Poulenc Rorer<br />

za Bellon Rhone<br />

Poulenc Rorer<br />

Lys Lez Lannoy,<br />

Francija<br />

28. 6. 2001 CLIVARIN 1750 reviparin 10 zˇe pripravljenih brizg po 0,25 ml B01AB08 Knoll AG, Ludwigshafen, Nemčija<br />

28. 6. 2001 COAXIL tianeptin zlozˇenka s 30 tabletami N06AX14 Les Laboratoires Servier<br />

Industrie, Gidy,<br />

Francija<br />

Slovenija<br />

Slovenija<br />

Avstrija<br />

Avstrija<br />

Francija<br />

Francija<br />

Francija<br />

Francija<br />

Francija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1509


Datum<br />

veljavnosti<br />

Ime zdravila<br />

2. 4. 2003 CODEINI PHOSPHATIS<br />

TABLETTAE 0,03 g<br />

mednarodno<br />

nelastniško ime<br />

3. 11. 2003 COFFALGIN E tablete acetilsalicilna<br />

kislina<br />

3. 11. 2003 COFFALGIN E tablete acetilsalicilna<br />

kislina<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

kodein 10 × 30 mg R05DA04 Lekarna Ljubljana, PE<br />

Galenski laboratorij,<br />

1000 tablet (1 tableta vsebuje 300 mg<br />

acetilsalicilne kisline, 200 mg<br />

paracetamola, 30 mg kofeina)<br />

zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

dvojnem traku) (1 tableta vsebuje 300 mg<br />

acetilsalicilne kisline, 200 mg<br />

paracetamola in 30 mg kofeina)<br />

26. 10. 2005 COLDREX paracetamol zlozˇenka z 12 tabletami (1 × 12 tablet v<br />

pretisnem omotu)<br />

26. 10. 2005 COLDREX paracetamol zlozˇenka s 24 tabletami (2 × 12 tablet v<br />

pretisnem omotu)<br />

20. 12. 2001 COLESTID zrnca holestipol zlozˇenka s 50 vrečkami po 5 g zrnc<br />

(5 g/5 g)<br />

20. 9. 2004 COLOCLENS sirup senini glikozidi zlozˇenka s stekleničko po 75 ml sirupa in<br />

odmerno zˇličko<br />

N02BE51 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N02BE51 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N02BE51 SmithKline Beecham,<br />

Dungarvan, Republika Irska<br />

za<br />

N02BE51 SmithKline Beecham,<br />

Dungarvan, Republika Irska<br />

za<br />

C10AC02 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

A06AB06 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

SmithKline Beecham<br />

Consumer Healthcare,<br />

Brentford<br />

SmithKline Beecham<br />

Consumer Healthcare,<br />

Brentford<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

20. 12. 2001 CONCEPTROL nonoksinol-9 10 × 150 mg G02BB Cilag AG, Schaffhausen, Švica<br />

2. 4. 2003 CONCOR 10 bisoprolol 30 × 10 mg C07AB07 MERCK KGaA, Darmstadt, Nemčija<br />

2. 4. 2003 CONCOR 5 bisoprolol 30 × 5 mg C07AB07 MERCK KGaA, Darmstadt, Nemčija<br />

15. 2. 2004 CONET imipenem zlozˇenka z 1 vialo s praškom (500 mg<br />

imipenema + 500 mg cilastatina v obliki<br />

natrijeve soli)<br />

J01DH51 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

28. 6. 2001 CONTROLOC pantoprazol 28 × 40 mg A02BC02 Byk Gulden Lomberg<br />

Chemische Fabrik GmbH,<br />

28. 6. 2001 CONTROLOC pantoprazol 14 × 40 mg A02BC02 Byk Gulden Lomberg<br />

Chemische Fabrik GmbH,<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Hrvaška<br />

Konstanz Nemčija<br />

Konstanz Nemčija<br />

28. 6. 2001 CONVULEX kapsule 150 mg valprojska kislina 100 × 150 mg N03AG01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

28. 6. 2001 CONVULEX kapsule 300 mg valprojska kislina 100 × 300 mg N03AG01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

28. 6. 2001 CONVULEX kapsule 500 mg valprojska kislina 100 × 500 mg N03AG01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

28. 6. 2001 CONVULEX raztopina 300mg/ml valprojska kislina steklenička po 100 ml (300mg/1ml) N03AG01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

28. 6. 2001 CONVULEX sirup za otroke<br />

50mg/ml<br />

valprojska kislina steklenička po 100 ml sirupa (50mg/1ml) N03AG01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

1510 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 7. 2002 COPAXONE injekcije 20 mg glatiramer acetat 1 modra zlozˇenka, ki vsebuje 4 zlozˇenke<br />

po 7 vial Copaxone-a in 1 bela zlozˇenka,<br />

ki vsebuje 4 zlozˇenke po 7 ampul vode<br />

za injekcije<br />

29. 11. 2004 CORDARONE injekcije<br />

150 mg/3 ml<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

L04AA07 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

amiodaron zlozˇenka s 6 ampulami po 3 ml raztopine C01BD01 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

29. 11. 2004 CORDARONE tablete 200 mg amiodaron zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

29. 11. 2004 CORDARONE tablete 200 mg amiodaron zlozˇenka s 60 tabletami (6 × 10 tablet v<br />

pretisnem omotu)<br />

C01BD01 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

C01BD01 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

10. 11. 2002 CORDIPIN RETARD nifedipin 30 × 20 mg C08CA05 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

24. 6. 2004 CORVATON molsidomin zlozˇenka s 30 tabletami po 2 mg (3 × 10<br />

tablet v pretisnem omotu)<br />

29. 11. 2004 CORYOL tablete 12,5 mg karvedilol zlozˇenka z 28 tabletami v pretisnem<br />

omotu<br />

29. 11. 2004 CORYOL tablete 25 mg karvedilol zlozˇenka z 28 tabletami v pretisnem<br />

omotu<br />

7. 5. 2004 COSOPT timolol zlozˇenka s plastičnim vsebnikom (s<br />

kapalnim nastavkom) po 5 ml raztopine<br />

(1 ml raztopine vsebuje 5 mg timolola in<br />

20 mg dorzolamida)<br />

C01DX12 Hoechst Marion Roussel<br />

Deutschland<br />

GmbH,Frankfurt,<br />

C07AG02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

C07AG02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

S01ED51 Laboratoires MERCK SHARP<br />

& DOHME-Chibret,<br />

7. 7. 2002 CRIXIVAN indinavir 180 × 400 mg J05AE02 MERCK SHARP & DOHME<br />

B.V., Haarlem<br />

7. 7. 2002 CRIXIVAN indinavir 360 × 200 mg J05AE02 MERCK SHARP & DOHME<br />

B.V., Haarlem<br />

29. 11. 2004 CRIXIVAN 333 mg indinavir zlozˇenka s plastenko po 135 kapsul J05AE02 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

12. 7. 2004 CUTIVATE krema flutikazon zlozˇenka s tubo po 15 g kreme D07AC17 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

12. 7. 2004 CUTIVATE krema flutikazon zlozˇenka s tubo po 30 g kreme D07AC17 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

12. 7. 2004 CUTIVATE mazilo flutikazon zlozˇenka s tubo po 30 g mazila D07AC17 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

d.d., Ljubljana Slovenija<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

Nemčija / Hoechst<br />

Marion Roussel GmbH,<br />

Dunaj<br />

Francija za MSD IDEA<br />

Inc., Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Avstrija<br />

Slovenija<br />

Slovenija<br />

Nizozemska<br />

Nizozemska<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1511


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

12. 7. 2004 CUTIVATE mazilo flutikazon zlozˇenka s tubo po 15 g mazila D07AC17 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

20. 9. 2004 CYCLO- PROGYNOVA norgestrel zlozˇenka z 21 tabletami (11 belih in 10<br />

svetlo rjavih tablet v pretisnem omotu)<br />

24. 6. 2004 CYCLO-MENORETTE levonorgestrel zlozˇenka z 21 tabletami v pretisnem<br />

omotu (11 belih in 10 roza tablet)<br />

16. 12. 2002 CYTOSAR 100 mg citarabin zlozˇenka z 1 vialo po 100 mg citarabina<br />

in 1ampulo po 5 ml topila<br />

16. 12. 2002 CYTOSAR 500 mg citarabin zlozˇenka z 1 vialo po 500 mg citarabina<br />

in 1 vialo po 10 ml topila<br />

12. 11. 2004 DABROSTON 10 mg tablete didrogesteron zlozˇenka s 30 tabletami (2 × 15 tablet v<br />

pretisnem omotu)<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

G03FB01 Schering AG, Berlin, Nemčija<br />

G03FB09 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

L01BC01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

L01BC01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

G03DB01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

20. 9. 2004 DAIVONEX krema kalcipotriol zlozˇenka s tubo po 30 g kreme (50 µg/g) D05AX02 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

2. 4. 2003 DAIVONEX mazilo kalcipotriol tuba po 100 g (50 µg/g) D05AX02 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

2. 4. 2003 DAIVONEX mazilo kalcipotriol tuba po 30 g (50 µg/g) D05AX02 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

8. 5. 2003 DALACIN C 150 mg kapsule klindamicin zlozˇenka s 16 kapsulami (2 × 8 kapsul v<br />

pretisnem omotu)<br />

J01FF01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

8. 5. 2003 DALACIN C 300 mg klindamicin zlozˇenka z 1 ampulo po 2 ml raztopine J01FF01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

8. 5. 2003 DALACIN C 300 mg kapsule klindamicin zlozˇenka s 16 kapsulami (4 × 4 kapsule v<br />

pretisnem omotu)<br />

J01FF01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

8. 5. 2003 DALACIN C 600 mg klindamicin zlozˇenka z 1 ampulo po 4 ml raztopine J01FF01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

8. 5. 2003 DALACIN C 900 mg klindamicin zlozˇenka s 3 ampulami po 6 ml raztopine J01FF01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

8. 5. 2003 DALACIN C sirup klindamicin zlozˇenka s steklenim vsebnikom z zrnci<br />

za pripravo 80 ml sirupa<br />

J01FF01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

sodelovanju z Wyeth-<br />

Lederle Pharma GmbH,<br />

Dunaj<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Avstrija<br />

Hrvaška<br />

Koppenhagen Danska<br />

Koppenhagen Danska<br />

Koppenhagen Danska<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

1512 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

8. 5. 2003 DALACIN T dermalna emulzija klindamicin zlozˇenka s plastičnim vsebnikom po<br />

30 ml emulzije<br />

8. 5. 2003 DALACIN T dermalna emulzija klindamicin zlozˇenka s plastičnim vsebnikom po<br />

60 ml emulzije<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

D10AF01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

D10AF01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

8. 5. 2003 DALACIN T gel klindamicin zlozˇenka s tubo po 30 g gela D10AF01 Pharmacia & Upjohn Co.,<br />

Kalamazoo, ZDA za<br />

18. 1. 2001 DALACIN vaginalna krema klindamicin zlozˇenka s tubo po 40 g kreme in 7<br />

aplikatorjev<br />

G01AA10 Pharmacia & Upjohn Co.,<br />

Kalamazoo, ZDA za<br />

28. 6. 2001 DALBEN suspenzija albendazol steklenička po 10ml (400mg/10ml) P02CA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 DALBEN tablete 200 mg albendazol 2 × 200 mg P02CA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 DALBEN tablete 400 mg albendazol 56 × 400 mg P02CA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

26. 7. 2005 DALERON COLD3 filmsko<br />

oblozˇene tablete<br />

26. 7. 2005 DALERON COLD3 filmsko<br />

oblozˇene tablete<br />

10. 7. 2005 DALERON peroralna suspenzija<br />

120 mg/5 ml<br />

paracetamol zlozˇenka z 12 tabletami (1 × 12 tablet v<br />

pretisnem omotu)<br />

paracetamol zlozˇenka s 24 tabletami (2 × 12 tablet v<br />

pretisnem omotu)<br />

paracetamol zlozˇenka s stekleničko po 100 ml<br />

suspenzije in brizgo za peroralno dajanje<br />

10. 7. 2005 DALERON tablete 500 mg paracetamol zlozˇenka z 12 tabletami (2 × 6 tablet v<br />

pretisnem omotu)<br />

24. 6. 2005 DALIVON tablete paracetamol zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

N02BE71 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

N02BE71 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

N02BE01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

N02BE01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

N02BE51 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 DANOVAL danazol 100 × 100 mg G03XA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

3. 11. 2003 DANOVAL danazol 100 × 200 mg G03XA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

7. 7. 2002 DAONIL glibenklamid zlozˇenka s 30 tabletami (30 × 5 mg) A10BB01 Usiphar, Groupe Hoechst<br />

Marion Roussel, Francija<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Pharmacio & Upjohn<br />

S.A., Luxemburg<br />

Pharmacio & Upjohn<br />

S.A., Luxemburg<br />

sodelovanju s Sanofi,<br />

Francija<br />

sodelovanju s Sanofi,<br />

Francija<br />

za Hoechst Marion<br />

Roussel GmbH, Dunaj,<br />

Avstrija<br />

1. 7. 2004 DAROB sotalol zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

C07AA07 Knoll AG, Ludwigshafen, Nemčija<br />

1. 7. 2004 DAROB MITE sotalol zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

C07AA07 Knoll AG, Ludwigshafen, Nemčija<br />

8. 11. 2001 DARTELIN tablete 400 mg pentoksifilin 20 × 400 mg C04AD03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

12. 1. 2003 DECA DURABOLIN nandrolon 12 ampul po 1 ml (50 mg/ml) A14AB01 N. V. Organon, Oss, Nizozemska<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1513


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 5. 2004 DEGAN injekcije 10 mg/2 ml metoklopramid zlozˇenka s 50 ampulami po 2 ml<br />

raztopine<br />

7. 5. 2004 DEGAN tablete 10 mg metoklopramid zlozˇenka s steklenim vsebnikom po 40<br />

tablet<br />

2. 6. 2005 DEPAKINE CHRONO tablete<br />

300 mg<br />

2. 6. 2005 DEPAKINE CHRONO tablete<br />

500 mg<br />

valprojska kislina zlozˇenka z dvema plastičnima<br />

vsebnikoma po 50 tablet<br />

valprojska kislina zlozˇenka s plastičnim vsebnikom po 30<br />

tablet<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

A03FA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

A03FA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N03AG01 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

N03AG01 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

23. 10. 2003 DEPO-MEDROL metilprednizolon zlozˇenka z 1 vialo po 1 ml suspenzije H02AB04 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

3. 7. 2003 DEPO-PROVERA 150 mg medroksiprogesteron<br />

3. 7. 2003 DEPO-PROVERA 500 mg medroksiprogesteron<br />

9. 7. 2003 DERMAZIN krema 1 % srebrov<br />

sulfadiazin<br />

9. 7. 2003 DERMAZIN krema 1 % srebrov<br />

sulfadiazin<br />

zlozˇenka z 1 vialo po 1 ml suspenzije G03DA02 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

zlozˇenka z 1 vialo po 3,3 ml suspenzije L02AB02 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

tuba po 50 g (10 mg/g) D06BA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

lonček po 250 g (10 mg/g) D06BA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 DETRALEX diosmin zlozˇenka s 30 tabletami C05CA03 Les Laboratoires Servier<br />

Industrie, Gidy,<br />

7. 10. 2004 DETRUNORM propiverin zlozˇenka z 28 tabletami (4 × 7 tablet v<br />

pretisnem omotu)<br />

20. 9. 2004 DETRUSITOL 1 mg tolterodin zlozˇenka s plastičnim vsebnikom s 60<br />

tabletami<br />

20. 9. 2004 DETRUSITOL 2 mg tolterodin zlozˇenka s 56 tabletami (4 × 14 tablet v<br />

pretisnem omotu)<br />

20. 9. 2004 DETRUSITOL 2 mg tolterodin zlozˇenka s 14 tabletami (1 × 14 tablet v<br />

pretisnem omotu)<br />

G04BD06 Apogepha Arzneimittel<br />

GmbH, Dresden, Nemčija za<br />

G04BD07 Pharmacia & Upjohn SpA,<br />

Marino del Tronto, Ascoli<br />

G04BD07 Pharmacia & Upjohn SpA,<br />

Marino del Tronto, Ascoli<br />

G04BD07 Pharmacia & Upjohn SpA,<br />

Marino del Tronto, Ascoli<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Slovenija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Scheringh-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Piceno, Italija za<br />

Pharmacio & Upjohn<br />

S.A.<br />

Piceno, Italija za<br />

Pharmacio & Upjohn<br />

S.A.<br />

Piceno, Italija za<br />

Pharmacio & Upjohn<br />

S.A.<br />

Francija<br />

Luksemburg<br />

Luksemburg<br />

Luksemburg<br />

1514 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 5. 2004 DEVIDON injekcije 50 mg/5 ml trazodon zlozˇenka z 10 ampulami po 5 ml<br />

raztopine<br />

7. 5. 2004 DEVIDON tablete 100 mg trazodon zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

7. 5. 2004 DEVIDON tablete 50 mg trazodon zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

N06AX05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N06AX05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N06AX05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

12. 4. 2001 DEXAMETHASON deksametazon 25 ampul po 1 ml (4mg/1ml) H02AB02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 DEXAMETHASON injekcije<br />

4 mg/ml<br />

deksametazon 25 ampul po 1 ml (4 mg/ml) H02AB02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

12. 4. 2001 DEXAMETHASON tablete deksametazon 10 × 0,5 mg H02AB02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 DEXAMETHASON tablete 0,5 mg deksametazon 10 × 0,5 mg H02AB02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

12. 1. 2003 DEXAMETHASON- NEOMYCIN<br />

kapljice za oko in uho<br />

12. 1. 2003 DEXAMETHASON- NEOMYCIN<br />

krema<br />

12. 1. 2003 DEXAMETHASON- NEOMYCIN<br />

mazilo za oko<br />

deksametazon kapalna steklenička po 5 ml S03CA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

deksametazon tuba po 20 g D07CB04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

deksametazon tuba po 3,5 g S01CA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

28. 6. 2001 DHC CONTINUS 120 mg dihidrokodein zlozˇenka s plastičnim vsebnikom po 56<br />

tablet<br />

28. 6. 2001 DHC CONTINUS 60 mg dihidrokodein zlozˇenka s plastičnim vsebnikom po 56<br />

tablet<br />

28. 6. 2001 DHC CONTINUS 90 mg dihidrokodein zlozˇenka s plastičnim vsebnikom po 56<br />

tablet<br />

1. 7. 2004 DIABINESE tablete 250 mg klorpropamid zlozˇenka s 30 tabletami (2 × 15 tablet v<br />

pretisnem omotu)<br />

20. 12. 2001 DIAMOX injekcije acetazolamid steklenička po 500 mg praška<br />

(500mg/5ml)<br />

20. 12. 2001 DIAMOX kapsule s prirejenim<br />

sproščanjem 250 mg<br />

20. 12. 2001 DIAMOX kapsule s prirejenim<br />

sproščanjem 250 mg<br />

N02AA08 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

N02AA08 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

N02AA08 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

A10BB02 Alkaloid d.d., Skopje,<br />

Republika Makedonija v<br />

S01EC01 Lederle, American Cyanamid<br />

Company<br />

acetazolamid 100 × 250 mg S01EC01 Lederle, American Cyanamid<br />

Company<br />

acetazolamid 28 × 250 mg S01EC01 Lederle, American Cyanamid<br />

Company<br />

20. 12. 2001 DIAMOX tablete 125 mg acetazolamid 100 × 125 mg S01EC01 Lederle, American Cyanamid<br />

Company<br />

20. 12. 2001 DIAMOX tablete 250 mg acetazolamid 100 × 250 mg S01EC01 Lederle, American Cyanamid<br />

Company<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Company, Hamilton,<br />

Bermuda<br />

Company, Hamilton,<br />

Bermuda<br />

Company, Hamilton,<br />

Bermuda<br />

sodelovanju s Pfizer<br />

Inc., New York, ZDA<br />

ZDA<br />

ZDA<br />

ZDA<br />

ZDA<br />

ZDA<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1515


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

12. 7. 2004 DIANE-35 ciproteron zlozˇenka s 63 tabletami (3 × 21 tablet v<br />

pretisnem omotu)<br />

3. 11. 2003 DIANEAL PD1 1,36% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

3. 11. 2003 DIANEAL PD1 1,36% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

3. 11. 2003 DIANEAL PD1 2,27% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

3. 11. 2003 DIANEAL PD1 2,27% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

3. 11. 2003 DIANEAL PD1 3,86% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

3. 11. 2003 DIANEAL PD1 3,86% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

24. 6. 2004 DIANEAL PD4 Glucosae 3,86% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

24. 6. 2004 DIANEAL PD4 Glucosae 3,86% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

24. 6. 2004 DIANEAL PD4 Glucosae 3,86% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

24. 6. 2004 DIANEAL PD4 Glucosae 1,36% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

G03HB01 Schering AG, Berlin, Nemčija<br />

vrečka po 5000 ml B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

vrečka po 2000 ml B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

vrečka po 5000 ml B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

vrečka po 2000 ml B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

vrečka po 5000 ml B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

vrečka po 2000 ml B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

dvojna plastična vrečka po 2000 ml<br />

raztopine<br />

enojna plastična vrečka po 5000 ml<br />

raztopine<br />

dvojna plastična vrečka po 2500 ml<br />

raztopine<br />

enojna plastična vrečka po 5000 ml<br />

raztopine<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

1516 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

24. 6. 2004 DIANEAL PD4 Glucosae 1,36% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

24. 6. 2004 DIANEAL PD4 Glucosae 1,36% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

24. 6. 2004 DIANEAL PD4 Glucosae 1,36% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

24. 6. 2004 DIANEAL PD4 Glucosae 2,27% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

24. 6. 2004 DIANEAL PD4 Glucosae 2,27% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

24. 6. 2004 DIANEAL PD4 Glucosae 2,27% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

24. 6. 2004 DIANEAL PD4 Glucosae 2,27% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

24. 6. 2004 DIANEAL PD4 Glucosae 3,86% (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

enojna plastična vrečka po 2000 ml<br />

raztopine<br />

dvojna plastična vrečka po 2500 ml<br />

raztopine<br />

dvojna plastična vrečka po 2000 ml<br />

raztopine<br />

enojna plastična vrečka po 5000 ml<br />

raztopine<br />

enojna plastična vrečka po 2000 ml<br />

raztopine<br />

dvojna plastična vrečka po 2000 ml<br />

raztopine<br />

dvojna plastična vrečka po 2500 ml<br />

raztopine<br />

enojna plastična vrečka po 2000 ml<br />

raztopine<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

3. 11. 2003 DIASTABOL 100 miglitol 30 × 100 mg A10BF02 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

3. 11. 2003 DIASTABOL 50 miglitol 30 × 50 mg A10BF02 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

19. 3. 2004 DICYNONE injekcije<br />

250 mg/2 ml<br />

19. 3. 2004 DICYNONE injekcije<br />

250 mg/2 ml<br />

etamsilat zlozˇenka z 10 ampulami po 2 ml<br />

raztopine<br />

etamsilat zlozˇenka s 50 ampulami po 2 ml<br />

raztopine<br />

19. 3. 2004 DICYNONE tablete 250 mg etamsilat zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

B02BX01 LEK, d.d., Ljubljana, v<br />

sodelovanju z OM Pharma,<br />

B02BX01 LEK, d.d., Ljubljana, v<br />

sodelovanju z OM Pharma,<br />

B02BX01 LEK, d.d., Ljubljana, v<br />

sodelovanju z OM Pharma,<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

Zˇeneva, Švica<br />

Zˇeneva, Švica<br />

Zˇeneva, Švica<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1517


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

12. 1. 2003 DIFLAZON flukonazol 1 × 150 mg J02AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 1. 2003 DIFLAZON flukonazol 7 × 200 mg J02AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

24. 6. 2004 DIFLAZON flukonazol zlozˇenka z vialo po 100 ml raztopine<br />

(2 mg/ml)<br />

J02AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 1. 2003 DIFLAZON flukonazol 20 × 200 mg J02AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 1. 2003 DIFLAZON flukonazol 7 × 50 mg J02AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 1. 2003 DIFLAZON flukonazol 28 × 100 mg J02AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

7. 5. 2004 DIFLUCAN flukonazol zlozˇenka s 7 kapsulami po 50 mg (1 × 7<br />

kapsul v pretisnem omotu)<br />

7. 5. 2004 DIFLUCAN flukonazol zlozˇenka s stekleničko po 100 ml<br />

raztopine (2 mg/ml)<br />

7. 5. 2004 DIFLUCAN flukonazol zlozˇenka z eno kapsulo v pretisnem<br />

omotu (1 × 150 mg)<br />

7. 5. 2004 DIFLUCAN flukonazol zlozˇenka s 28 kapsulami po 100 mg<br />

(4 × 7 kapsul v pretisnem omotu)<br />

7. 5. 2004 DIFLUCAN flukonazol zlozˇenka s 7 kapsulami po 100 mg<br />

(1 × 7 kapsul v pretisnem omotu)<br />

J02AC01 Pfizer S.A., Francija, za Pfizer<br />

International<br />

J02AC01 Pfizer S.A., Francija, za Pfizer<br />

International<br />

J02AC01 Pfizer S.A., Francija, za Pfizer<br />

International<br />

J02AC01 Pfizer S.A., Francija, za Pfizer<br />

International<br />

J02AC01 Pfizer S.A., Francija, za Pfizer<br />

International<br />

30. 5. 2002 DIGENOL cisaprid 20 × 20 mg A03FA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 DIGENOL 10 mg tablete cisaprid 30 × 10 mg A03FA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 DIGENOL 5 mg tablete cisaprid 30 × 5 mg A03FA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 DIGENOL suspenzija 1mg/1ml cisaprid steklenička po 100ml (1mg/1ml) A03FA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 DIGICOR injekcije 0,2 mg/2 ml metildigoksin 25 ampul po 2 ml (0,2 mg/2ml) C01AA08 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 DIGICOR tablete 0,1 mg metildigoksin 30 × 0,1 mg C01AA08 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

12. 1. 2003 DIHALAR ketotifen steklenička po 100 ml sirupa (1 mg/<br />

5 ml)<br />

R06AX17 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

12. 1. 2003 DIHALAR ketotifen 30 × 1 mg R06AX17 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

Inc., New York, ZDA<br />

Inc., New York, ZDA<br />

Inc., New York, ZDA<br />

Inc., New York, ZDA<br />

Inc., New York, ZDA<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

sodelovanju z Novartis<br />

Pharma Ltd., Švica<br />

sodelovanju z Novartis<br />

Pharma Ltd., Švica<br />

1518 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

12. 1. 2003 DIHYDERGOT NASAL SPRAY<br />

4 mg/ml<br />

mednarodno<br />

nelastniško ime<br />

dihidroergotamin plastični vsebnik z ampulo po 1 ml<br />

(4 mg/ml) in vnašalnik<br />

24. 6. 2004 DILATREND tablete 12,5 mg karvedilol zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

17. 12. 2004 DILATREND tablete 25 mg karvedilol zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

24. 6. 2004 DILATREND tablete 6,25 mg karvedilol zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

24. 6. 2004 DIMIDRIL sirup difenhidramin zlozˇenka s stekleničko po 100 ml sirupa<br />

(10 mg/5 ml)<br />

24. 6. 2004 DIMIDRIL tablete difenhidramin zlozˇenka s 30 tabletami po 25 mg<br />

(3 × 10 tablet v pretisnem omotu)<br />

4. 1. 2004 DIOVAN 160 mg valsartan škatla z 28 kapsulami po 160 mg (2 × 14<br />

kapsul v pretisnem omotu)<br />

4. 1. 2004 DIOVAN 80 mg valsartan škatla z 28 kapsulami po 80 mg (2 × 14<br />

kapsul v pretisnem omotu)<br />

7. 12. 2003 DIPEPTIVEN 100 ml alanilglutamin steklenička po 100 ml koncentrata<br />

(20 g/100 ml)<br />

7. 12. 2003 DIPEPTIVEN 50 ml alanilglutamin steklenička po 50 ml koncentrata<br />

(10 g/50 ml)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

N02CA01 Novartis Pharma AG, Basel Švica<br />

C07AG02 Roche Diagnostics GmbH,<br />

Mannheim, Nemčija za<br />

C07AG02 Roche Diagnostics GmbH,<br />

Mannheim, Nemčija za<br />

C07AG02 Roche Diagnostics GmbH,<br />

Mannheim, Nemčija za<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

R06AA02 Pliva d.d., Zagreb Hrvaška<br />

R06AA02 Pliva d.d., Zagreb Hrvaška<br />

C09CA03 Novartis Pharma AG, Basel Švica<br />

C09CA03 Novartis Pharma AG, Basel Švica<br />

B05XB02 Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

B05XB02 Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

7. 3. 2002 DIPRIVAN propofol 1 steklenička po 100 ml (1g/100ml) N01AX10 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

7. 3. 2002 DIPRIVAN propofol zlozˇenka s 5 ampulami po 20 ml<br />

emulzije (200mg/20ml)<br />

7. 3. 2002 DIPRIVAN propofol zlozˇenka s stekleničko po 50 ml emulzije<br />

(500mg/50ml)<br />

7. 3. 2002 DIPRIVAN 1 % propofol zlozˇenka z napolnjeno injekcijsko brizgo<br />

po 50 ml emulzije (500 mg/50 ml),<br />

batom za injekcijsko brizgo in spojnikom<br />

N01AX10 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

N01AX10 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

N01AX10 Zeneca S.p.A., Caponago<br />

(Milano), Italija za<br />

1. 7. 2004 DIPROGENTA krema betametazon zlozˇenka s tubo po 15 g kreme D07CC01 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

1. 7. 2004 DIPROGENTA mazilo betametazon zlozˇenka s tubo po 15 g mazila D07CC01 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

1. 10. 2004 DIPROSALIC dermalna raztopina betametazon zlozˇenka s plastenko po 30 ml raztopine D07XC01 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

1. 10. 2004 DIPROSALIC dermalna raztopina betametazon zlozˇenka s plastenko po 100 ml<br />

raztopine<br />

D07XC01 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

Zeneca Limited,<br />

Macclesfield, Cheshire<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Nemčija<br />

Nemčija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1519


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

1. 10. 2004 DIPROSALIC mazilo betametazon zlozˇenka s tubo po 50 g mazila D07XC01 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

1. 10. 2004 DIPROSALIC mazilo betametazon zlozˇenka s tubo po 15 g mazila D07XC01 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

1. 10. 2004 DIPROSONE krema betametazon zlozˇenka s tubo po 500 g kreme D07AC01 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

1. 10. 2004 DIPROSONE krema betametazon zlozˇenka s tubo po 15 g kreme D07AC01 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

1. 10. 2004 DIPROSONE mazilo betametazon zlozˇenka s tubo po 500 g mazila D07AC01 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

1. 10. 2004 DIPROSONE mazilo betametazon zlozˇenka s tubo po 15 g mazila D07AC01 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

2. 4. 2003 DISOPYRAMIDE dizopiramid 50 × 100 mg C01BA03 Jadran, Galenski laboratorij<br />

d.d., Rijeka, Hrvaška<br />

4. 1. 2004 DIVERIN DRAZˇEJI ibuprofen škatla z 20 tabletami po 200 mg (2 × 10<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 DIVERIN GEL ibuprofen škatla s stekleničko (z odmernim<br />

ventilom) po 30 g gela (50 mg/g)<br />

9. 7. 2003 DOBUTAMIN GIULINI 250 mg,<br />

prašek za infuzijo<br />

23. 11. 2003 DOLANTIN injekcije<br />

100 mg/2 ml<br />

M01AE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

M02AA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

dobutamin viala po 250 mg C01CA07 Solvay Pharmaceuticals<br />

GmbH, Hannover,<br />

petidin zlozˇenka s 5 ampulami po 2 ml raztopine N02AB02 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

30. 11. 2005 DOLGIT krema ibuprofen zlozˇenka s tubo po 50 g kreme M02AA13 Dolorgiet Pharmaceuticals,<br />

St. Augustin, Bonn<br />

30. 11. 2005 DOLGIT krema ibuprofen zlozˇenka s tubo po 100 g kreme<br />

(50 mg/g)<br />

M02AA13 Dolorgiet Pharmaceuticals,<br />

St. Augustin, Bonn<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Nemčija<br />

Frankfurt am Main Nemčija<br />

20. 12. 2001 DOLTARD tablete 10 mg morfin 100 × 10 mg N02AA01 Nycomed DAK A/S, Roskilde Danska<br />

20. 12. 2001 DOLTARD tablete 10 mg morfin 20 × 10 mg N02AA01 Nycomed DAK A/S, Roskilde Danska<br />

20. 12. 2001 DOLTARD tablete 100 mg morfin 100 × 100 mg N02AA01 Nycomed DAK A/S, Roskilde Danska<br />

20. 12. 2001 DOLTARD tablete 100 mg morfin 20 × 100 mg N02AA01 Nycomed DAK A/S, Roskilde Danska<br />

20. 12. 2001 DOLTARD tablete 30 mg morfin 100 × 30 mg N02AA01 Nycomed DAK A/S, Roskilde Danska<br />

20. 12. 2001 DOLTARD tablete 30 mg morfin 20 × 30 mg N02AA01 Nycomed DAK A/S, Roskilde Danska<br />

20. 12. 2001 DOLTARD tablete 60 mg morfin 100 × 60 mg N02AA01 Nycomed DAK A/S, Roskilde Danska<br />

Nemčija<br />

Nemčija<br />

1520 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

20. 12. 2001 DOLTARD tablete 60 mg morfin 20 × 60 mg N02AA01 Nycomed DAK A/S, Roskilde Danska<br />

28. 6. 2001 DOPAMIN FRESENIUS<br />

50 mg/5 ml<br />

dopamin zlozˇenka z 10 ampulami po 5 ml<br />

koncentrata<br />

C01CA04 Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

16. 12. 2002 DORMICUM midazolam 30 × 7,5 mg N05CD08 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

30. 5. 2002 DORMICUM midazolam 10 × 7,5 mg N05CD08 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

30. 5. 2002 DORMICUM midazolam 10 ampul po 5 ml (5mg/5ml) N05CD08 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

30. 5. 2002 DORMICUM midazolam 5 ampul po 10 ml (50mg/10ml) N05CD08 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

24. 6. 2004 DORMICUM tablete midazolam zlozˇenka z 10 tabletami po 15 mg<br />

(1 × 10 tablet v pretisnem omotu)<br />

4. 1. 2004 DORSIFLEX tablete 200 mg mefenoksalon škatla s 30 tabletami po 200 mg (3 × 10<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 DORSIFLEX tablete 200 mg mefenoksalon škatla s 100 tabletami po 200 mg<br />

(10 × 10 tablet v pretisnem omotu)<br />

N05CD08 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

N05BX01 LEK, d.d., Ljubljana, v<br />

sodelovanju z Drossapharm<br />

N05BX01 LEK, d.d., Ljubljana, v<br />

sodelovanju z Drossapharm<br />

25. 2. 2005 DOTAREM 0,5 mmol/ml gadoterna kislina zlozˇenka z vialo po 15 ml raztopine V08CA02 Laboratoire Guerbet, Aulnaysous-Bois<br />

9. 7. 2003 DOXILEK kapsule 500 mg kalcijev dobesilat 30 × 500 mg C05BX01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

28. 6. 2001 DRAMINA dimenhidrinat 10 × 50 mg R06AA02 Jadran, Galenski laboratorij<br />

d.d., Rijeka, Hrvaška<br />

2. 4. 2003 DULCOLAX bisakodil 6 × 10 mg A06AB02 Boehringer Ingelheim<br />

International GmbH,<br />

2. 4. 2003 DULCOLAX bisakodil 30 × 5 mg A06AB02 Boehringer Ingelheim<br />

International GmbH,<br />

2. 6. 2005 DUROGESIC 100 µg/h fentanil zlozˇenka s 5 transdermalnimi oblizˇi N02AB03 Janssen Pharmaceutica N.V.,<br />

Beerse,<br />

2. 6. 2005 DUROGESIC 25 µg/h fentanil zlozˇenka s 5 transdermalnimi oblizˇi N02AB03 Janssen Pharmaceutica N.V.,<br />

Beerse,<br />

2. 6. 2005 DUROGESIC 50 µg/h fentanil zlozˇenka s 5 transdermalnimi oblizˇi N02AB03 Janssen Pharmaceutica N.V.,<br />

Beerse,<br />

19. 3. 2004 EBRANTIL 60 retard kapsule urapidil zlozˇenka s 50 kapsulami (5 × 10 kapsul v<br />

pretisnem omotu)<br />

19. 3. 2004 EBRANTIL 90 retard kapsule urapidil zlozˇenka s 50 kapsulami (5 × 10 kapsul v<br />

pretisnem omotu)<br />

C02CA06 Byk Gulden Lomberg<br />

Chemische Fabrik GmbH,<br />

C02CA06 Byk Gulden Lomberg<br />

Chemische Fabrik GmbH,<br />

AG, Basel, Švica<br />

AG, Basel, Švica<br />

Nemčija<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Francija<br />

d.d., Ljubljana Slovenija<br />

Ingelheim am Rhein Nemčija<br />

Ingelheim am Rhein Nemčija<br />

Belgija<br />

Belgija<br />

Belgija<br />

Konstanz Nemčija<br />

Konstanz Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1521


Datum<br />

veljavnosti<br />

Ime zdravila<br />

10. 7. 2005 ECALIN 1% dermalno pršilo,<br />

raztopina<br />

12. 11. 2004 ECALIN 150 mg vaginalne<br />

globule<br />

mednarodno<br />

nelastniško ime<br />

ekonazol zlozˇenka s plastičnim vsebnikom (z<br />

zaporko z mehanskim pršilnikom) po<br />

50 g raztopine<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

D01AC03 Jaka- 80 AD- Radoviš,<br />

Farmacevtska, kozmetična<br />

ekonazol zlozˇenka s 3 globulami v dvojnem traku G01AF05 Jaka- 80 AD- Radoviš,<br />

Farmacevtska, kozmetična<br />

12. 11. 2004 ECALIN krema 1% ekonazol zlozˇenka s tubo po 30 g kreme D01AC03 Jaka- 80 AD- Radoviš,<br />

Farmacevtska, kozmetična<br />

21. 5. 2004 ECHOVIST-200 mikrodelci<br />

galaktoze<br />

21. 5. 2004 ECHOVIST-300 mikrodelci<br />

galaktoze<br />

2. 4. 2003 EDEMID FORTE injekcije<br />

250 mg/10 ml<br />

zlozˇenka z vialo po 3 g praška, vialo po<br />

13,5 ml raztopine galaktoze in cevko<br />

zlozˇenka z vialo po 3 g praška, vialo po<br />

8,5 ml raztopine galaktoze in cevko<br />

in dietetična industrija,<br />

Radoviš<br />

in dietetična industrija,<br />

Radoviš<br />

in dietetična industrija,<br />

Radoviš<br />

Republika<br />

Makedonija<br />

Republika<br />

Makedonija<br />

Republika<br />

Makedonija<br />

V08DA02 Schering AG, Berlin, Nemčija<br />

V08DA02 Schering AG, Berlin, Nemčija<br />

furosemid 5 ampul po 10 ml (250 mg/10 ml) C03CA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 EDEMID FORTE tablete 500 mg furosemid 20 × 500 mg C03CA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 EDEMID injekcije 20 mg/2ml furosemid 5 ampul po 2 ml (20 mg/2ml) C03CA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 EDEMID tablete 40 mg furosemid 12 × 40 mg C03CA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

24. 6. 2004 EDICIN injekcije 0,5 g vankomicin zlozˇenka z eno vialo s praškom J01XA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

24. 6. 2004 EDICIN injekcije 1 g vankomicin zlozˇenka z eno vialo s praškom J01XA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

29. 11. 2004 EDRONAX 4 mg reboksetin zlozˇenka s 60 tabletami (3 × 20 tablet v<br />

pretisnem omotu)<br />

N06AX18 Pharmacia & Upjohn SpA,<br />

Marino del Tronto, Ascoli<br />

2. 6. 2005 EFECTIN ER kapsule po 150 mg venlafaksin zlozˇenka s plastenko po 100 kapsul N06AX16 Wyeth Medica Ireland,<br />

Newbridge, Co. Kildare,<br />

2. 6. 2005 EFECTIN ER kapsule po 150 mg venlafaksin zlozˇenka z 28 kapsulami (2 × 14 kapsul<br />

v pretisnem omotu)<br />

2. 6. 2005 EFECTIN ER kapsule po 150 mg venlafaksin zlozˇenka s 30 kapsulami (3 × 10 kapsul v<br />

pretisnem omotu)<br />

N06AX16 Wyeth Medica Ireland,<br />

Newbridge, Co. Kildare,<br />

N06AX16 Wyeth Medica Ireland,<br />

Newbridge, Co. Kildare,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Piceno, Italija za<br />

Pharmacio & Upjohn<br />

S.A.<br />

Irska za Wyeth —<br />

Lederle Pharma GmbH,<br />

Dunaj<br />

Irska za Wyeth —<br />

Lederle Pharma GmbH,<br />

Dunaj<br />

Irska za Wyeth —<br />

Lederle Pharma GmbH,<br />

Dunaj<br />

Luksemburg<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

1522 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

2. 6. 2005 EFECTIN ER kapsule po 75 mg venlafaksin zlozˇenka z 28 kapsulami (2 × 14 kapsul<br />

v pretisnem omotu)<br />

2. 6. 2005 EFECTIN ER kapsule po 75 mg venlafaksin zlozˇenka s 30 kapsulami (3 × 10 kapsul v<br />

pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

N06AX16 Wyeth Medica Ireland,<br />

Newbridge, Co. Kildare,<br />

N06AX16 Wyeth Medica Ireland,<br />

Newbridge, Co. Kildare,<br />

2. 6. 2005 EFECTIN ER kapsule po 75 mg venlafaksin zlozˇenka s plastenko po 100 kapsul N06AX16 Wyeth Medica Ireland,<br />

Newbridge, Co. Kildare,<br />

2. 6. 2005 EFECTIN tablete po 37,5 mg venlafaksin zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

2. 6. 2005 EFECTIN tablete po 37,5 mg venlafaksin zlozˇenka s 56 tabletami (4 × 14 tablet v<br />

pretisnem omotu)<br />

N06AX16 Wyeth Laboratories, New<br />

Lane, Havant, Velika<br />

N06AX16 Wyeth Laboratories, New<br />

Lane, Havant, Velika<br />

2. 6. 2005 EFECTIN tablete po 37,5 mg venlafaksin zlozˇenka s plastenko po 100 tablet N06AX16 Wyeth Laboratories, New<br />

Lane, Havant, Velika<br />

2. 6. 2005 EFECTIN tablete po 50 mg venlafaksin zlozˇenka s plastenko po 100 tablet N06AX16 Wyeth Laboratories, New<br />

Lane, Havant, Velika<br />

2. 6. 2005 EFECTIN tablete po 50 mg venlafaksin zlozˇenka z 42 tabletami (2 × 21 tablet v<br />

pretisnem omotu)<br />

N06AX16 Wyeth Laboratories, New<br />

Lane, Havant, Velika<br />

2. 6. 2005 EFECTIN tablete po 75 mg venlafaksin zlozˇenka s plastenko po 100 tablet N06AX16 Wyeth Laboratories, New<br />

Lane, Havant, Velika<br />

2. 6. 2005 EFECTIN tablete po 75 mg venlafaksin zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

2. 6. 2005 EFECTIN tablete po 75 mg venlafaksin zlozˇenka s 56 tabletami (4 × 14 tablet v<br />

pretisnem omotu)<br />

9. 7. 2003 EFFERALGAN 150 mg, svečke za<br />

majhne otroke<br />

9. 7. 2003 EFFERALGAN 300 mg, svečke za<br />

otroke<br />

9. 7. 2003 EFFERALGAN 500 mg, šumeče<br />

tablete<br />

9. 7. 2003 EFFERALGAN 600 mg, svečke za<br />

odrasle<br />

N06AX16 Wyeth Laboratories, New<br />

Lane, Havant, Velika<br />

N06AX16 Wyeth Laboratories, New<br />

Lane, Havant, Velika<br />

Irska za Wyeth —<br />

Lederle Pharma GmbH,<br />

Dunaj<br />

Irska za Wyeth —<br />

Lederle Pharma GmbH,<br />

Dunaj<br />

Irska za Wyeth —<br />

Lederle Pharma GmbH,<br />

Dunaj<br />

Britanija za Wyeth —<br />

Lederle Pharma GmbH,<br />

Avstrija<br />

Britanija za Wyeth —<br />

Lederle Pharma GmbH,<br />

Avstrija<br />

Britanija za Wyeth —<br />

Lederle Pharma GmbH,<br />

Avstrija<br />

Britanija za Wyeth —<br />

Lederle Pharma GmbH,<br />

Avstrija<br />

Britanija za Wyeth —<br />

Lederle Pharma GmbH,<br />

Avstrija<br />

Britanija za Wyeth —<br />

Lederle Pharma GmbH,<br />

Avstrija<br />

Britanija za Wyeth —<br />

Lederle Pharma GmbH,<br />

Avstrija<br />

Britanija za Wyeth —<br />

Lederle Pharma GmbH,<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

paracetamol zlozˇenka z 10 svečkami N02BE01 Laboratoires UPSA, Francija<br />

paracetamol zlozˇenka z 10 svečkami N02BE01 Laboratoires UPSA, Francija<br />

paracetamol zlozˇenka s 16 šumečimi tabletami (4 × 4<br />

tablete v dvojnem traku)<br />

N02BE01 Laboratoires UPSA, Francija<br />

paracetamol zlozˇenka z 10 svečkami N02BE01 Laboratoires UPSA, Francija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1523


Datum<br />

veljavnosti<br />

Ime zdravila<br />

9. 7. 2003 EFFERALGAN 80 mg, svečke za<br />

dojenčke<br />

9. 7. 2003 EFFERALGAN raztopina za<br />

otroke<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

paracetamol zlozˇenka z 10 svečkami N02BE01 Laboratoires UPSA, Francija<br />

paracetamol zlozˇenka s stekleničko po 90 ml<br />

raztopine<br />

N02BE01 Laboratoires UPSA, Francija<br />

9. 7. 2003 EFFERALGAN z vitaminom C paracetamol zlozˇenka z 10 šumečimi tabletami N02BE51 Laboratoires UPSA, Francija<br />

9. 7. 2003 EFFERALGAN z vitaminom C paracetamol zlozˇenka z 20 šumečimi tabletami N02BE51 Laboratoires UPSA, Francija<br />

12. 7. 2004 EFFORTIL etilefrin zlozˇenka s plastičnim vsebnikom z 20 C01CA01 Boehringer Ingelheim<br />

Boehringer Ingelheim Nemčija<br />

tabletami (20 × 5 mg)<br />

Pharma KG, Nemčija za International GmbH<br />

10. 11. 2002 EFLORAN metronidazol steklenička po 100 ml (5 mg/ml) J01XD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

10. 11. 2002 EFLORAN metronidazol 10 × 400 mg P01AB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

3. 11. 2003 ELDERIN tablete 300 mg etodolak 20 × 300 mg M01AB08 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

8. 11. 2001 ELTROXIN 100 natrijev<br />

100 × 0,1 mg H03AA01 Glaxo Wellcome S.A.,<br />

Glaxo Wellcome<br />

levotiroksinat<br />

Aranda de Duero, Španija, za Export Ltd., Velika<br />

Britanija<br />

8. 11. 2001 ELTROXIN 50 natrijev<br />

100 × 0,05 mg H03AA01 Glaxo Wellcome S.A.,<br />

Glaxo Wellcome<br />

levotiroksinat<br />

Aranda de Duero, Španija, za Export Ltd., Velika<br />

Britanija<br />

7. 7. 2002 EMLA oblizˇ lidokain zlozˇenka po 20 oblizˇev N01BB20 ASTRA, Pharmaceutical<br />

production, Södertälje<br />

Švedska<br />

19. 3. 2004 ENAP 10 enalapril zlozˇenka z 20 tabletami po 10 mg (2 × C09AA02 KRKA, tovarna zdravil, d.d.,<br />

Slovenija<br />

10 tablet v pretisnem omotu)<br />

Novo mesto,<br />

12. 4. 2001 ENAP 2,5 enalapril 20 × 2,5mg C09AA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

19. 3. 2004 ENAP 20 enalapril zlozˇenka z 20 tabletami po 20 mg (2 × C09AA02 KRKA, tovarna zdravil, d.d.,<br />

Slovenija<br />

10 tablet v pretisnem omotu)<br />

Novo mesto,<br />

8. 11. 2001 ENAP injekcije enalapril 5 ampul po 1 ml (1,25mg/1ml) C09AA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

2. 4. 2003 ENAP-HL enalapril 20 tablet C09BA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

4. 1. 2004 ENCEPUR cepivo proti škatla z napolnjeno injekcijsko brizgo po J07BA01 Chiron Behring GmbH &<br />

Nemčija<br />

klopnemu<br />

0,5 ml suspenzije (1,5 µg/0,5 ml) in<br />

Co., Marburg<br />

meningoencefalitisu<br />

z<br />

inaktiviranimi<br />

virusi<br />

injekcijsko iglo<br />

7. 3. 2002 ENGERIX B 10 prečiščen antigen<br />

virusa hepatitisa<br />

tipa B<br />

vnaprej napolnjena brizga (0,5 ml) z<br />

10 µg antigenov HbsAg<br />

J07BC01 SmithKline Beecham<br />

Biologicals s.a., Rixensart,<br />

Belgija<br />

1524 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 3. 2002 ENGERIX B 20 prečiščen antigen<br />

virusa hepatitisa<br />

tipa B<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

vnaprej napolnjena brizga (1 ml) z 20 µg<br />

antigenov HbsAg<br />

J07BC01 SmithKline Beecham<br />

Biologicals s.a., Rixensart,<br />

2. 4. 2003 EPIAL karbamazepin 50 × 200 mg N03AF01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

16. 12. 2002 EPIVIR RAZTOPINA lamivudin plastenka po 240 ml (10 mg/ml) J05AF05 Glaxo Wellcome Operations,<br />

Greenford<br />

16. 12. 2002 EPIVIR TABLETE lamivudin 60 × 150 mg J05AF05 Glaxo Wellcome Operations,<br />

Greenford<br />

10. 11. 2002 EPOMAX INJEKCIJE 4000 I. E./ml epoetin omega,<br />

rekombinantni<br />

humani<br />

10. 11. 2002 EPOMAX INJEKCIJE 1000 I.<br />

E./ 0,5 ml<br />

10. 11. 2002 EPOMAX INJEKCIJE 1000 I.<br />

E./0,5 ml<br />

10. 11. 2002 EPOMAX INJEKCIJE 2000 I.<br />

E./0,5 ml<br />

10. 11. 2002 EPOMAX INJEKCIJE 2000 I.<br />

E./0,5 ml<br />

10. 11. 2002 EPOMAX INJEKCIJE 3000 I.<br />

E./0,75 ml<br />

10. 11. 2002 EPOMAX INJEKCIJE 3000 I.<br />

E./0,75 ml<br />

epoetin omega,<br />

rekombinantni<br />

humani<br />

epoetin omega,<br />

rekombinantni<br />

humani<br />

epoetin omega,<br />

rekombinantni<br />

humani<br />

epoetin omega,<br />

rekombinantni<br />

humani<br />

epoetin omega,<br />

rekombinantni<br />

humani<br />

epoetin omega,<br />

rekombinantni<br />

humani<br />

10. 11. 2002 EPOMAX INJEKCIJE 4000 I. E./ml epoetin omega,<br />

rekombinantni<br />

humani<br />

10. 11. 2002 EPOMAX INJEKCIJE 500 I.<br />

E./0,25 ml<br />

10. 11. 2002 EPOMAX INJEKCIJE 500 I.<br />

E./0,25 ml<br />

epoetin omega,<br />

rekombinantni<br />

humani<br />

epoetin omega,<br />

rekombinantni<br />

humani<br />

1 napolnjena injekcijska brizga po 1 ml<br />

(4000 I. E./ml)<br />

1 napolnjena injekcijska brizga po 0,5 ml<br />

(1000 I. E./0,5 ml)<br />

6 napolnjenih injekcijskih brizg po<br />

0,5 ml (1000 I. E./0,5 ml)<br />

1 napolnjena injekcijska brizga po 0,5 ml<br />

(2000 I. E./0,5 ml)<br />

6 napolnjenih injekcijskih brizg po<br />

0,5 ml (2000 I. E./0,5 ml)<br />

1 napolnjena injekcijska brizga po<br />

0,75 ml (3000 I. E./0,75 ml)<br />

6 napolnjenih injekcijskih brizg po<br />

0,75 ml (3000 I. E./0,75 ml)<br />

6 napolnjenih injekcijskih brizg po 1 ml<br />

(4000 I. E./ml)<br />

1 napolnjena injekcijska brizga po<br />

0,25 ml (500 I. E./0,25ml)<br />

6 napolnjenih injekcijskih brizg po<br />

0,25 ml (500 I. E./0,25 ml)<br />

B03XA01 LEK d.d., Ljubljana v<br />

sodelovanju z Elanex Pharma<br />

B03XA01 LEK d.d., Ljubljana v<br />

sodelovanju z Elanex Pharma<br />

B03XA01 LEK d.d., Ljubljana v<br />

sodelovanju z Elanex Pharma<br />

B03XA01 LEK d.d., Ljubljana v<br />

sodelovanju z Elanex Pharma<br />

B03XA01 LEK d.d., Ljubljana v<br />

sodelovanju z Elanex Pharma<br />

B03XA01 LEK d.d., Ljubljana v<br />

sodelovanju z Elanex Pharma<br />

B03XA01 LEK d.d., Ljubljana v<br />

sodelovanju z Elanex Pharma<br />

B03XA01 LEK d.d., Ljubljana v<br />

sodelovanju z Elanex Pharma<br />

B03XA01 LEK d.d., Ljubljana v<br />

sodelovanju z Elanex Pharma<br />

B03XA01 LEK d.d., Ljubljana v<br />

sodelovanju z Elanex Pharma<br />

2. 4. 2003 ERAZON piroksikam tuba po 35 g (10 mg/g) M02AA07 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Belgija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

(IOM), Ltd. Slovenija<br />

(IOM), Ltd. Slovenija<br />

(IOM), Ltd. Slovenija<br />

(IOM), Ltd. Slovenija<br />

(IOM), Ltd. Slovenija<br />

(IOM), Ltd. Slovenija<br />

(IOM), Ltd. Slovenija<br />

(IOM), Ltd. Slovenija<br />

(IOM), Ltd. Slovenija<br />

(IOM), Ltd. Slovenija<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1525


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

2. 4. 2003 ERAZON piroksikam 10 × 20 mg M01AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

2. 4. 2003 ERAZON piroksikam 20 × 20 mg M01AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

2. 4. 2003 ERAZON piroksikam tuba po 35 g (10 mg/g) M02AA07 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

24. 6. 2005 ERAZON kapsule 10 mg piroksikam zlozˇenka z 20 kapsulami (2 × 10 kapsul<br />

v pretisnem omotu)<br />

19. 3. 2004 ERGOMETRIN injekcije<br />

0,2 mg/ml<br />

ergometrin zlozˇenka s 50 ampulami po 1 ml<br />

raztopine<br />

19. 3. 2004 ERGOMETRIN tablete 0,2 mg ergometrin zlozˇenka s steklenim vsebnikom po 20<br />

tablet<br />

24. 6. 2004 ERGOTYL injekcije 0,2 mg/ml metilergometrin zlozˇenka s 50 ampulami po 1 ml<br />

raztopine<br />

24. 6. 2004 ERGOTYL raztopina 0,25 mg/ml metilergometrin zlozˇenka s stekleničko po 15 ml<br />

raztopine in plastično kapalko<br />

3. 11. 2003 ESTRACOMB TTS estradiol 4 oblizˇi Estraderm TTS 50 velikosti<br />

10 cm2 (4 mg estradiola/oblizˇ) in 4 oblizˇi<br />

Estragest TTS 0,25/50 velikosti 20 cm2<br />

(10 mg estradiola + 30 mg<br />

noretisteronacetata/oblizˇ)<br />

M01AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

G02AB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

G02AB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

G02AB01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

G02AB01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 ESTROFEM estradiol 28 × 2 mg G03CA03 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

7. 3. 2002 ESTROFEM FORTE estradiol 28 × 4 mg G03CA03 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

20. 9. 2004 ETAMBUTOL 400 mg tablete etambutol zlozˇenka s stekleničko po 100 tablet J04AK02 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

G03FB05 Novartis Pharma AG, Basel Švica<br />

4. 1. 2004 ETOGEL etofenamat škatla s tubo po 40 g gela (50 mg/g) M02AA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

20. 9. 2004 EUGLUCON glibenklamid zlozˇenka s 30 tabletami po 5 mg (3 × 10<br />

tablet v pretisnem omotu)<br />

A10BB01 Pliva d.d., Zagreb Hrvaška<br />

3. 10. 2005 EURAX emulzija krotamiton zlozˇenka s stekleničko po 50 ml emulzije D04AX Novartis Consumer Health<br />

SA, Nyon,<br />

Švica<br />

3. 10. 2005 EURAX krema krotamiton zlozˇenka s tubo po 20 g kreme D04AX Novartis Consumer Health<br />

SA, Nyon,<br />

Švica<br />

30. 11. 2005 EVISTA raloksifen zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

G03XC01 Eli Lilly and Company<br />

Limited, Basingstoke<br />

2. 4. 2003 EXELON kapsule 0,5 mg rivastigmin 28 × 0,5 mg N06DA03 Novartis Pharma AG, Basel Švica<br />

2. 4. 2003 EXELON kapsule 1,5 mg rivastigmin 28 × 1,5 mg N06DA03 Novartis Pharma AG, Basel Švica<br />

Danska<br />

Danska<br />

Hrvaška<br />

Velika<br />

Britanija<br />

1526 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

2. 4. 2003 EXELON kapsule 1 mg rivastigmin 28 × 1 mg N06DA03 Novartis Pharma AG, Basel Švica<br />

2. 4. 2003 EXELON kapsule 3 mg rivastigmin 28 × 3 mg N06DA03 Novartis Pharma AG, Basel Švica<br />

2. 4. 2003 EXELON kapsule 4,5 mg rivastigmin 28 × 4,5 mg N06DA03 Novartis Pharma AG, Basel Švica<br />

2. 4. 2003 EXELON kapsule 6 mg rivastigmin 28 × 6 mg N06DA03 Novartis Pharma AG, Basel Švica<br />

28. 6. 2001 FAKTU mazilo cinhokain zlozˇenka s tubo po 20 g mazila in<br />

aplikatorjem<br />

C05AD04 Byk Gulden Lomberg<br />

Chemische Fabrik GmbH,<br />

28. 6. 2001 FAKTU svečke cinhokain 10 svečk C05AD04 Byk Gulden Lomberg<br />

Chemische Fabrik GmbH,<br />

4. 9. 2005 FARESTON toremifen zlozˇenka s 100 tabletami (10 × 10 tablet<br />

v pretisnem omotu)<br />

4. 9. 2005 FARESTON toremifen zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

L02BA02 Orion Corporation, Turku,<br />

Finska za Schering -<br />

L02BA02 Orion Corporation, Turku,<br />

Finska za Schering -<br />

24. 6. 2004 FARMORUBICIN PFS 10 mg epirubicin zlozˇenka z eno vialo po 5 ml raztopine L01DB03 Pharmacia & Upjohn S.p.A.,<br />

Nerviano, Italija za<br />

24. 6. 2004 FARMORUBICIN PFS 50 mg epirubicin zlozˇenka z eno vialo po 25 ml raztopine L01DB03 Pharmacia & Upjohn S.p.A.,<br />

Nerviano, Italija za<br />

2. 6. 2005 FEM 7 50 µg estradiol zlozˇenka s 4 transdermalnimi oblizˇi G03CA03 LTS Lohmann Therapie-<br />

Systeme AG, Andernach,<br />

2. 6. 2005 FEM 7 75 µg estradiol zlozˇenka s 4 transdermalnimi oblizˇi G03CA03 LTS Lohmann Therapie-<br />

Systeme AG, Andernach,<br />

2. 6. 2005 FEM 7 100 µg estradiol zlozˇenka s 4 transdermalnimi oblizˇi G03CA03 LTS Lohmann Therapie-<br />

Systeme AG, Andernach,<br />

17. 12. 2004 FENALGIN tablete paracetamol zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

dvojnem traku)<br />

17. 12. 2004 FENALGIN tablete paracetamol zlozˇenka s 1000 tabletami (100 × 10<br />

tablet v dvojnem traku)<br />

17. 12. 2004 FENALGIN tablete paracetamol zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

dvojnem traku)<br />

N02BE51 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N02BE51 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N02BE51 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

28. 6. 2001 FENISTIL gel dimetinden zlozˇenka s tubo po 30 g gela D04AA13 Novartis Consumer Health<br />

SA, Nyon,<br />

28. 6. 2001 FENISTIL kapljice dimetinden zlozˇenka s stekleničko po 20 ml<br />

raztopine<br />

R06AB03 Novartis Consumer Health<br />

SA, Nyon,<br />

28. 6. 2001 FENISTIL kapsule dimetinden zlozˇenka z 10 kapsulami R06AB03 Novartis Consumer Health<br />

SA, Nyon,<br />

9. 7. 2003 FENORIN kapsule 375 mg karbocistein 30 × 375 mg R05CB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Konstanz Nemčija<br />

Konstanz Nemčija<br />

Plough Central East<br />

AG, Luzern, Švica<br />

Plough Central East<br />

AG, Luzern, Švica<br />

Pharmacio & Upjohn<br />

S.A., Luxemburg<br />

Pharmacio & Upjohn<br />

S.A., Luxemburg<br />

Nemčija za MERCK<br />

KGaA, Darmstadt<br />

Nemčija za MERCK<br />

KGaA, Darmstadt<br />

Nemčija za MERCK<br />

KGaA, Darmstadt<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Švica<br />

Švica<br />

Švica<br />

d.d., Ljubljana Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1527


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

9. 7. 2003 FENORIN P sirup 125 mg/5 ml karbocistein steklenička po 120 ml (125 mg/5 ml) R05CB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 FENORIN sirup 250 mg/5 ml karbocistein steklenička po 120 ml (250 mg/5 ml) R05CB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 FERRUM LEK injekcije<br />

100 mg/2ml<br />

2. 4. 2003 FERRUM LEK injekcije<br />

100 mg/2ml 5 ampul<br />

kompleks<br />

zˇelezovega(III)<br />

oksida s<br />

polimaltozo<br />

kompleks<br />

zˇelezovega(III)<br />

oksida s<br />

polimaltozo<br />

9. 7. 2003 FERRUM LEK kapljice 50 mg/ml kompleks<br />

zˇelezovega(III)<br />

oksida s<br />

polimaltozo<br />

9. 7. 2003 FERRUM LEK sirup 50 mg/5 ml kompleks<br />

zˇelezovega(III)<br />

oksida s<br />

polimaltozo<br />

9. 7. 2003 FERRUM LEK zˇvečljive tablete<br />

100 mg<br />

kompleks<br />

zˇelezovega(III)<br />

oksida s<br />

polimaltozo<br />

9. 7. 2003 FIBROGAMMIN P 1250 E koagulacijski<br />

faktor XIII<br />

9. 7. 2003 FIBROGAMMIN P 250 E koagulacijski<br />

faktor XIII<br />

8. 11. 2001 FIBROLAN mazilo fibrinolizin in<br />

dezoksiribonukleaza<br />

8. 11. 2001 FIBROLAN prašek fibrinolizin in<br />

dezoksiribonukleaza<br />

50 ampul po 2 ml (100 mg/2ml) B03AC01 LEK, d.d., Ljubljana, v<br />

sodelovanju z Vifor<br />

5 ampul po 2 ml (100 mg/2ml) B03AC01 LEK, d.d., Ljubljana, v<br />

sodelovanju z Vifor<br />

kapalna steklenička po 30 ml (50 mg/ml) B03AB05 LEK, d.d., Ljubljana, v<br />

sodelovanju z Vifor<br />

steklenička po 100 ml (50 mg/5 ml) B03AB05 LEK, d.d., Ljubljana, v<br />

sodelovanju z Vifor<br />

30 × 100 mg B03AB05 LEK, d.d., Ljubljana, v<br />

sodelovanju z Vifor<br />

viala s praškom (1250 I.E.) in viala po<br />

20 ml vode za injekcije<br />

viala s praškom (250 I.E.) in ampula po<br />

4 ml vode za injekcije<br />

B02BD07 Centeon Pharma GmbH,<br />

Dunaj,<br />

B02BD07 Centeon Pharma GmbH,<br />

Dunaj,<br />

zlozˇenka s tubo po 50 g mazila B06AA02 Gödecke AG, Freiburg/Parke-<br />

Davis GmbH Berlin,<br />

zlozˇenka s prebodno stekleničko s<br />

praškom za pripravo dermalne raztopine<br />

B06AA02 Gödecke AG, Freiburg/Parke-<br />

Davis GmbH Berlin,<br />

2. 4. 2003 FLAGYL 250 mg metronidazol 20 × 250 mg P01AB01 Rhone Poulenc Rorer,<br />

Antony Cedex,<br />

2. 4. 2003 FLAGYL 500 mg metronidazol 14 × 500 mg P01AB01 Rhone Poulenc Rorer,<br />

Antony Cedex,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

(International) Inc., St.<br />

Gallen, Švica<br />

(International) Inc., St.<br />

Gallen, Švica<br />

(International) Inc., St.<br />

Gallen, Švica<br />

(International) Inc., St.<br />

Gallen, Švica<br />

(International) Inc., St.<br />

Gallen, Švica<br />

Avstrija<br />

Avstrija<br />

Freiburg Nemčija<br />

Freiburg Nemčija<br />

Francija<br />

Francija<br />

1528 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

2. 4. 2003 FLAGYL 500 mg/100 ml<br />

INFUZIJE<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

metronidazol steklenica po 100 ml (500 mg/100 ml) J01XD01 Rhone Poulenc Rorer,<br />

Antony Cedex,<br />

2. 4. 2003 FLAGYL vaginalne globule metronidazol 10 × 500 mg G01AF01 Rhone Poulenc Rorer,<br />

Antony Cedex,<br />

19. 3. 2004 FLAREX fluorometolon zlozˇenka s kapalno plastenko po 5 ml<br />

suspenzije<br />

5. 6. 2005 FLIXONASE kapljice za nos flutikazon zlozˇenka z 28 enoodmernimi plastičnimi<br />

vsebniki po 0,4 ml suspenzije (4 × 7<br />

vsebnikov v dvojnem traku)<br />

(0,4 mg/0,4 ml)<br />

12. 3. 2004 FLIXONASE pršilo za nos flutikazon zlozˇenka s stekleničko — z odmerno<br />

črpalko in nosnikom — s suspenzijo (za<br />

120 odmerkov)<br />

18. 12. 2003 FLIXOTIDE 125 pršilnik flutikazon zlozˇenka z vsebnikom s suspezijo z<br />

zaporko z odmernim ventilom in<br />

ustnikom (za 60 odmerkov)<br />

18. 12. 2003 FLIXOTIDE 25 pršilnik flutikazon zlozˇenka z vsebnikom s suspezijo z<br />

zaporko z odmernim ventilom in<br />

ustnikom (za 60 odmerkov)<br />

18. 12. 2003 FLIXOTIDE 250 pršilnik flutikazon zlozˇenka z vsebnikom s suspezijo z<br />

zaporko z odmernim ventilom in<br />

ustnikom (za 60 odmerkov)<br />

18. 12. 2003 FLIXOTIDE 50 pršilnik flutikazon zlozˇenka z vsebnikom s suspezijo z<br />

zaporko z odmernim ventilom in<br />

ustnikom (za 60 odmerkov)<br />

17. 12. 2004 FLONIDAN peroralna suspenzija<br />

5 mg/5 ml<br />

loratadin zlozˇenka s stekleničko po 120 ml<br />

suspenzije in merilno zˇličko<br />

17. 12. 2004 FLONIDAN S tablete 10 mg loratadin zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

17. 12. 2004 FLONIDAN tablete 10 mg loratadin zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

S01BA07 S.A. Alcon-Couvreur N.V.,<br />

Puurs, Belgija za Alcon<br />

R01AD08 Glaxo Wellcome Australia<br />

Ltd., Boronia<br />

R01AD08 Glaxo Wellcome S.A.,<br />

Aranda de Duero, Španija, za<br />

R03BA05 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

R03BA05 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

R03BA05 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

R03BA05 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

R06AX13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

R06AX13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

R06AX13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 FLOSTERON betametazon tuba po 30 g (0,5 mg/g) D07AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 FLOSTERON betametazon tuba po 30 g (0,5 mg/g) D07AC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 FLOSTERON betametazon 5 ampul po 1 ml (7 mg/ml) H02AB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 FLOSTERON G betametazon tuba po 30 g D07CC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 FLOSTERON G betametazon tuba po 30 g D07CC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Pharmaceuticals Ltd.,<br />

Hünenberg, Švica<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Francija<br />

Francija<br />

Avstralija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1529


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

9. 7. 2003 FLOSTERON S betametazon plastenka po 50 ml D07XC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 FLOSTERON S betametazon tuba po 30 g D07XC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

18. 12. 2003 FLUACET gel fluocinolonacetonid<br />

12. 4. 2001 FLUCINOM flutamid zlozˇenka s 100 tabletami (10 × 10 tablet<br />

v pretisnem omotu)<br />

zlozˇenka s tubo po 30 g gela D07AC04 Jadran, Galenski laboratorij<br />

d.d., Rijeka, Hrvaška<br />

L02BB01 Schering — Plough Labo N.<br />

V., Heist-op-den-Berg,<br />

7. 7. 2002 FLUDARA fludarabin 5 injekcijskih stekleničk po 50 mg L01BB05 Schering AG, Berlin, Nemčija<br />

3. 11. 2003 FLUIMUKAN disperzibilne tablete<br />

200 mg<br />

acetilcistein 20 × 200 mg R05CB01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 FLUIMUKAN granulat 100 mg acetilcistein 30 vrečk po 5 g zrnc (100 mg/5 g) R05CB01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 FLUIMUKAN granulat 200 mg acetilcistein 20 vrečk po 5 g zrnc (200 mg/5 g) R05CB01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

12. 11. 2004 FLUONATRIL 0,25 mg tablete natrijev fluorid zlozˇenka s plastičnim vsebnikom po 400<br />

tablet<br />

12. 11. 2004 FLUONATRIL 1 mg tablete natrijev fluorid zlozˇenka s plastičnim vsebnikom po 250<br />

tablet<br />

A01AA01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

A01AA01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

7. 3. 2002 FLUOROURACIL fluorouracil 5 ampul po 5 ml (250 mg/5 ml) L01BC02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

19. 12. 2005 FLUVAL kapsule 20 mg fluoksetin zlozˇenka s 14 kapsulami (2 × 7 kapsul v<br />

pretisnem omotu)<br />

19. 12. 2005 FLUVAL kapsule 20 mg fluoksetin zlozˇenka z 28 kapsulami (4 × 7 kapsul v<br />

pretisnem omotu)<br />

N06AB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

N06AB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 FLUZEPAM kapsule 30 mg flurazepam 10 × 30 mg N05CD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 FLUZEPAM kapsule 15 mg flurazepam 10 × 15 mg N05CD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

4. 1. 2004 FORTRAL pentazocin škatla z 10 ampulami po 1 ml<br />

(30 mg/ml)<br />

4. 1. 2004 FORTRAL pentazocin škatla s stekleničko po 100 tablet (100 ×<br />

50 mg)<br />

N02AD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

N02AD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

8. 5. 2003 FORTUM injekcije ceftazidim zlozˇenka z 1 vialo s praškom J01DA11 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

Slovenija<br />

Slovenija<br />

Belgija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

sodelovanju s Sanofi,<br />

Francija<br />

sodelovanju s Sanofi,<br />

Francija<br />

Export Ltd., Velika<br />

Britanija<br />

Hrvaška<br />

Hrvaška<br />

Švica<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

1530 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

4. 9. 2005 FORTUM MONOVIALA ceftazidim zlozˇenka z 1 monovialo s praškom (viala<br />

s plastičnim nastavkom z iglo)<br />

3. 11. 2003 FRAGMIN dalteparin<br />

(nizkomolekularni<br />

heparin)<br />

3. 11. 2003 FRAGMIN dalteparin<br />

(nizkomolekularni<br />

heparin)<br />

3. 11. 2003 FRAGMIN 10.000 I.E. dalteparin<br />

(nizkomolekularni<br />

heparin)<br />

19. 3. 2004 FRAHEPAN certoparin<br />

(nizkomolekularni<br />

heparin)<br />

20. 12. 2001 FRAHEPAN injekcije certoparin<br />

(nizkomolekularni<br />

heparin)<br />

19. 3. 2004 FRAXIPARINE injekcije 2850 I.E.<br />

AXa/0,3 ml<br />

19. 3. 2004 FRAXIPARINE injekcije 5700 I.E.<br />

AXa/0,6 ml<br />

19. 3. 2004 FRAXIPARINE injekcije 7600 I.E.<br />

AXa/0,8 ml<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

10 napolnjenih injekcijskih brizg po<br />

0,2 ml (2500 I.E. (anti-Xa)/0,2 ml)<br />

10 napolnjenih injekcijskih brizg po<br />

0,2 ml (5000 I.E. (anti-Xa)/0,2 ml)<br />

zlozˇenka z 10 ampulami po 1 ml<br />

raztopine (10000 I.E. (anti-Xa)/ml)<br />

zlozˇenka s 5 napolnjenimi injekcijskimi<br />

brizgami po 0,3 ml raztopine (3000 I.<br />

E./0,3 ml)<br />

J01DA11 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

B01AB04 Pharmacia & Upjohn AB,<br />

Švedska, za<br />

B01AB04 Pharmacia & Upjohn AB,<br />

Švedska, za<br />

B01AB04 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija za<br />

B01AB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

20 ampul po 0,5 ml (3000 I. E./0,5 ml) B01AB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

nadroparin zlozˇenka z 10 napolnjenimi injekcijskimi<br />

brizgami po 0,3 ml raztopine<br />

nadroparin zlozˇenka z 10 napolnjenimi injekcijskimi<br />

brizgami po 0,6 ml raztopine<br />

nadroparin zlozˇenka z 10 napolnjenimi injekcijskimi<br />

brizgami po 0,8 ml raztopine<br />

B01AB06 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

B01AB06 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

B01AB06 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

7. 3. 2002 FROMILID 250 klaritromicin 14 tablet po 250 mg J01FA09 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

7. 3. 2002 FROMILID 500 klaritromicin 14 tablet po 500 mg J01FA09 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

4. 10. 2004 FROMILID zrnca za peroralno<br />

suspenzijo 125 mg/5 ml<br />

8. 11. 2001 FSME IMMUN Inject cepivo proti<br />

klopnemu<br />

meningoencefalitisu<br />

z<br />

inaktiviranimi<br />

virusi<br />

klaritromicin zlozˇenka s stekleničko z zrnci za pripravo<br />

60 ml suspenzije<br />

4. 1. 2004 FUCIDIN fusidna kislina škatla z 12 tabletami po 250 mg (1 × 12<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 FUCIDIN fusidna kislina škatla s stekleničko po 90 ml suspenzije<br />

(50 mg/ml) in odmerno zˇličko<br />

J01FA09 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Export Ltd., Velika<br />

Britanija<br />

Pharmacio & Upjohn<br />

S.A. Luxemburg<br />

Pharmacio & Upjohn<br />

S.A. Luxemburg<br />

Pharmacio & Upjohn<br />

S.A., Luxemburg<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

naprej napolnjena brizga po 0,5 ml J07BA01 Immuno AG, Dunaj, Avstrija<br />

J01XC01 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

J01XC01 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

Koppenhagen Danska<br />

Koppenhagen Danska<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1531


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

4. 1. 2004 FUCIDIN fusidna kislina škatla z vialo po 500 mg natrijevega<br />

fusidata in vialo po 10 ml topila<br />

9. 7. 2003 FUCIDIN gaza fusidna kislina 10 prepojenih oblog velikosti 10 cm ×<br />

10 cm (1,5 g/oblogo)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

J01XC01 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

D09AA02 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

9. 7. 2003 FUCIDIN krema fusidna kislina tuba po 15 g (20 mg/g) D06AX01 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

9. 7. 2003 FUCIDIN mazilo fusidna kislina tuba po 15 g (20 mg/g) D06AX01 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

2. 4. 2003 GAMAMED ANTI-D 150 humani<br />

imunoglobulin<br />

anti-D (Rh)<br />

2. 4. 2003 GAMAMED ANTI-D 50 humani<br />

imunoglobulin<br />

anti-D (Rh)<br />

23. 10. 2003 GAMMA-VENIN P 2,5 g humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

23. 10. 2003 GAMMA-VENIN P 500 mg humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

1 viala po 1 ml (750 I.E./ml) J06BB01 Zavod RS za transfuzijo krvi,<br />

v sodelovanju s<br />

1 viala po 2 ml (250 I.E./2 ml) J06BB01 Zavod RS za transfuzijo krvi,<br />

v sodelovanju s<br />

zlozˇenka z 1 prebodno stekleničko s<br />

praškom in 1 prebodno stekleničko po<br />

50 ml vode za injekcije, set za prenos in<br />

set za infundiranje<br />

zlozˇenka z 1 prebodno stekleničko s<br />

praškom in 1 ampulo po 10 ml vode za<br />

injekcije<br />

J06BA02 Centeon Pharma GmbH,<br />

Marburg, Nemčija za<br />

J06BA02 Centeon Pharma GmbH,<br />

Marburg, Nemčija za<br />

11. 2. 2003 GARAMYCIN gentamicin 10 ampul po 2 ml (80 mg/2 ml) J01GB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 4. 2001 GARAMYCIN gentamicin 10 ampul po 1,5 ml (120 mg/1,5 ml) J01GB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 4. 2001 GARAMYCIN gentamicin 10 ampul po 2 ml (20 mg/2 ml) J01GB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 4. 2001 GARAMYCIN 0,1% gentamicin tuba po 15 g mazila D06AX07 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 4. 2001 GARAMYCIN kapljice za oko gentamicin steklenička po 5 ml raztopine (3mg/1ml) S01AA11 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 4. 2001 GARAMYCIN mazilo za oko gentamicin tuba po 3 g mazila (3mg/1g) S01AA11 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 4. 2004 GASTAL peroralna suspenzija aluminijev<br />

hidroksid<br />

9. 4. 2004 GASTAL tablete aluminijev<br />

hidroksid<br />

zlozˇenka z 20 vrečkami po 10 ml<br />

suspenzije<br />

zlozˇenka s 60 tabletami (10 × 6 tablet v<br />

dvojnem traku)<br />

Koppenhagen Danska<br />

Koppenhagen Danska<br />

Koppenhagen Danska<br />

Koppenhagen Danska<br />

Scottish National Blood<br />

Transfusion Service<br />

Scottish National Blood<br />

Transfusion Service<br />

Centeon Pharma<br />

GmbH, Dunaj, Avstrija<br />

Centeon Pharma<br />

GmbH, Dunaj, Avstrija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

A02AD01 Pliva d.d., Zagreb Hrvaška<br />

A02AD01 Pliva d.d., Zagreb Hrvaška<br />

1532 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

9. 4. 2004 GASTAL tablete aluminijev<br />

hidroksid<br />

21. 5. 2004 GASTROGRAFIN diatrizojska<br />

kislina<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

zlozˇenka s 30 tabletami (5 × 6 tablet v<br />

dvojnem traku)<br />

zlozˇenka s stekleničko po 100 ml<br />

raztopine<br />

21. 12. 2004 GASTROMIRO jopamidol zlozˇenka s stekleničko po 50 ml<br />

raztopine (30,62 g/50 ml)<br />

21. 12. 2004 GASTROMIRO jopamidol zlozˇenka s stekleničko po 20 ml<br />

raztopine (12,25 g/20 ml)<br />

21. 12. 2004 GASTROMIRO jopamidol zlozˇenka s stekleničko po 100 ml<br />

raztopine (61,24 g/100 ml)<br />

A02AD01 Pliva d.d., Zagreb Hrvaška<br />

V08AA01 Berlimed S.A., Madrid,<br />

Španija za Schering AG,<br />

Berlin Nemčija<br />

V08AB04 Bracco S.p.A., Milano Italija<br />

V08AB04 Bracco S.p.A., Milano Italija<br />

V08AB04 Bracco S.p.A., Milano Italija<br />

1. 7. 2004 GELOFUSINE derivati zˇelatine plastenka po 500 ml raztopine B05AA06 B. Braun Medical AG,<br />

Crissier, Švica za B. Braun<br />

Melsungen AG,<br />

Melsungen<br />

7. 3. 2002 GEMZAR 1 g gemcitabin 1 steklenička po 1 g L01BC05 Lilly France S.A., Fegersheim Francija<br />

7. 3. 2002 GEMZAR 200 mg gemcitabin 1 steklenička po 200 mg L01BC05 Lilly France S.A., Fegersheim Francija<br />

20. 12. 2001 GENOTROPIN 16 I.E. somatropin,<br />

rekombinantni<br />

humani<br />

20. 12. 2001 GENOTROPIN 4 I.E. somatropin,<br />

rekombinantni<br />

humani<br />

zlozˇenka z 1 dvodelnim vlozˇkom s<br />

praškom in topilom<br />

zlozˇenka z 1 dvodelnim vlozˇkom s<br />

praškom in topilom<br />

H01AC01 Pharmacia & Upjohn AB,<br />

Švedska, za<br />

H01AC01 Pharmacia & Upjohn AB,<br />

Švedska, za<br />

3. 11. 2003 GENTAMICIN gentamicin 10 ampul po 2 ml (80 mg/2ml) J01GB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 GENTAMICIN gentamicin 10 ampul po 2 ml (20 mg/2ml) J01GB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 GENTAMICIN gentamicin 10 ampul po 1 ml (40 mg/ml) J01GB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

7. 5. 2004 GENTAMICIN injekcije<br />

120 mg/2 ml<br />

7. 5. 2004 GENTAMICIN injekcije<br />

20 mg/2 ml<br />

7. 5. 2004 GENTAMICIN injekcije<br />

40 mg/2 ml<br />

7. 5. 2004 GENTAMICIN injekcije<br />

80 mg/2 ml<br />

3. 11. 2003 GENTAMICIN kapljice za oko<br />

3 mg/ml<br />

gentamicin zlozˇenka z 10 ampulami po 2 ml<br />

raztopine<br />

gentamicin zlozˇenka z 10 ampulami po 2 ml<br />

raztopine<br />

gentamicin zlozˇenka z 10 ampulami po 2 ml<br />

raztopine<br />

gentamicin zlozˇenka z 10 ampulami po 2 ml<br />

raztopine<br />

gentamicin steklenička po 5 ml (3 mg/ml) in plastični<br />

kapalni nastavek<br />

J01GB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01GB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01GB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01GB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

S01AA11 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 GENTAMICIN mazilo 0,1 % gentamicin tuba po 15 g (1 mg/g) D06AX07 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Pharmacio & Upjohn<br />

S.A. Luxemburg<br />

Pharmacio & Upjohn<br />

S.A. Luxemburg<br />

Nemčija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1533


Datum<br />

veljavnosti<br />

Ime zdravila<br />

3. 11. 2003 GENTAMICIN mazilo za oko<br />

0,3%<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

gentamicin tuba po 5 g (3 mg/g) S01AA11 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

9. 7. 2003 GEONISTIN oksitetraciklin 6 vaginalnih tablet G01AA51 Pliva d.d., Zagreb Hrvaška<br />

8. 11. 2001 GERODORM cinolazepam 30 × 40 mg N05CD13 Gerot Pharmazeutika, Dunaj, Avstrija<br />

8. 11. 2001 GERODORM cinolazepam 10 × 40 mg N05CD13 Gerot Pharmazeutika, Dunaj, Avstrija<br />

19. 3. 2004 GLAMIN aminokisline,<br />

kombinacije<br />

19. 3. 2004 GLAMIN aminokisline,<br />

kombinacije<br />

19. 3. 2004 GLAMIN aminokisline,<br />

kombinacije<br />

4. 1. 2004 GLANDOSANE (stomatološki<br />

pripravkipripravek<br />

za<br />

lokalno oralno<br />

zdravljenje)<br />

steklenica po 500 ml raztopine B05BA10 Pharmacia & Upjohn GmbH,<br />

Nemčija za Fresenius<br />

steklenica po 1000 ml raztopine B05BA10 Pharmacia & Upjohn GmbH,<br />

Nemčija za Fresenius<br />

steklenica po 250 ml raztopine B05BA10 Pharmacia & Upjohn GmbH,<br />

Nemčija za Fresenius<br />

zlozˇenka z vsebnikom po 50 ml<br />

raztopine z zaporko s pršilnim ventilom<br />

Kabi AB, Švedska za<br />

Fresenius Kabi<br />

Deutschland<br />

Kabi AB, Švedska za<br />

Fresenius Kabi<br />

Deutschland<br />

Kabi AB, Švedska za<br />

Fresenius Kabi<br />

Deutschland<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

A01AD11 cell pharm GmbH, Hannover Nemčija<br />

10. 11. 2002 GLIBENKLAMID TABLETE 5 mg glibenklamid 30 × 5 mg A10BB01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 GLUCAGEN 1 mg glukagon 1 steklenička po 1 mg glukagona in 1<br />

steklenička po 1 ml vode za injekcije<br />

7. 3. 2002 GLUCAGEN 1 mg HYPOKIT glukagon 1 steklenička po 1 mg glukagona in 1<br />

injekcijska brizga po 1ml vode za<br />

injekcije<br />

H04AA01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

H04AA01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

12. 1. 2003 GLUCOBAY 100 akarboza 30 × 100 mg A10BF01 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

12. 1. 2003 GLUCOBAY 50 akarboza 30 × 50 mg A10BF01 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

d.d., Ljubljana Slovenija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

2. 4. 2003 GLUCOPHAGE 850 mg metformin 100 × 850 mg A10BA02 Lipha Sante, Lyon, Francija<br />

9. 7. 2003 GLUCOSI INFUNDIBILE 10 % glukoza steklenica po 500 ml (110 mg/ml) B05BA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

20. 12. 2001 GLUCOSI INFUNDIBILE 10% glukoza plastenka po 500 ml B05BA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

8. 11. 2001 GLUCOSI INFUNDIBILE 10% glukoza infuzijska steklenica po 250 ml<br />

(110,0mg/1ml)<br />

B05BA03 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

Danska<br />

Danska<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

1534 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

8. 11. 2001 GLUCOSI INFUNDIBILE 10% glukoza infuzijska steklenica po 500 ml<br />

(110,0mg/1ml)<br />

8. 11. 2001 GLUCOSI INFUNDIBILE 20% glukoza infuzijska steklenica po 500 ml<br />

(220,0mg/1ml)<br />

8. 11. 2001 GLUCOSI INFUNDIBILE 3% glukoza infuzijska steklenica po 500 ml<br />

(33,0mg/1ml)<br />

8. 11. 2001 GLUCOSI INFUNDIBILE 40% glukoza infuzijska steklenica po 500 ml<br />

(440,0mg/1ml)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

B05BA03 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

B05BA03 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

B05BA03 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

B05BA03 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

9. 7. 2003 GLUCOSI INFUNDIBILE 5 % glukoza steklenica po 500 ml (55 mg/ml) B05BA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 4. 2001 GLUCOSI INFUNDIBILE 5% glukoza steklenica po 500 ml B05BA03 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

24. 6. 2004 GLUCOSI INFUNDIBILE 5% glukoza steklenica po 250 ml raztopine B05BA03 Zavod Republike Slovenije<br />

za transfuzijo krvi,<br />

28. 6. 2001 GLUCOSI INFUNDIBILE 5% glukoza plastiz´na vrez´ka po 250 ml (5%) B05BA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

20. 12. 2001 GLUCOSI INFUNDIBILE 5% glukoza plastenka po 500 ml B05BA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 GLUCOSI INFUNDIBILE 5% glukoza steklenička po 250 ml (5%) B05BA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

24. 6. 2004 GLUCOSI INFUNDIBILE 5% glukoza steklenička po 100 ml raztopine B05BA03 Zavod Republike Slovenije<br />

za transfuzijo krvi,<br />

30. 5. 2002 GLUCOTROL XL glipizid zlozˇenka s 30 tabletami v plastičnem<br />

vsebniku (30 × 10 mg)<br />

Farmacevtski oddelek-<br />

Pharmagena, Ljubljana<br />

Farmacevtski oddelek-<br />

Pharmagena, Ljubljana<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

A10BB07 Pfizer S.A. Francija<br />

7. 3. 2002 GLUCOTROL XL glipizid 30 × 5 mg A10BB07 Pfizer S.A. Francija<br />

12. 4. 2001 GLUKOSALINA 1:1 glukoza steklenička po 250 ml B05BB02 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

Slovenija<br />

20. 12. 2001 GLUKOSALINA 1:1 glukoza steklenička po 500 ml B05BB02 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

Slovenija<br />

12. 4. 2001 GLUKOSALINA 2:1 glukoza steklenička po 240 ml B05BB02 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

Slovenija<br />

12. 4. 2001 GLUKOSALINA 3:1 glukoza steklenička po 200 ml B05BB02 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

Slovenija<br />

20. 12. 2001 GLUKOSALINA 3:1 glukoza steklenička po 500 ml B05BB02 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

Slovenija<br />

24. 6. 2004 GLUKOZA 10% glukoza zlozˇenka z 10 prebodnimi steklenicami<br />

po 500 ml raztopine<br />

B05BA03 Pliva d.d., Zagreb Hrvaška<br />

12. 3. 2004 GLUKOZA 10% Braun glukoza plastenka iz polietilena po 500 ml<br />

raztopine<br />

B05BA03 B. Braun Melsungen AG,<br />

Melsungen<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1535


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

12. 3. 2004 GLUKOZA 20% Braun glukoza plastenka iz polietilena po 500 ml<br />

raztopine<br />

24. 6. 2004 GLUKOZA 5% glukoza zlozˇenka z 10 prebodnimi steklenicami<br />

po 500 ml raztopine<br />

12. 3. 2004 GLUKOZA 5% Braun glukoza plastenka iz polietilena po 250 ml<br />

raztopine<br />

12. 3. 2004 GLUKOZA 5% Braun glukoza plastenka iz polietilena po 1000 ml<br />

raztopine<br />

12. 3. 2004 GLUKOZA 5% Braun glukoza plastenka iz polietilena po 500 ml<br />

raztopine<br />

2. 4. 2003 GONAL — F 150 folitropin alfa,<br />

rekombinantni<br />

2. 4. 2003 GONAL — F 75 folitropin alfa,<br />

rekombinantni<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

10 ampul s praškom (150 I.E.) in 10<br />

ampul po 1 ml vode za injekcije<br />

10 ampul s praškom (75 I.E.) in 10<br />

ampul po 1 ml vode za injekcije<br />

B05BA03 B. Braun Melsungen AG,<br />

Melsungen<br />

Nemčija<br />

B05BA03 Pliva d.d., Zagreb Hrvaška<br />

B05BA03 B. Braun Melsungen AG,<br />

Melsungen<br />

B05BA03 B. Braun Melsungen AG,<br />

Melsungen<br />

B05BA03 B. Braun Melsungen AG,<br />

Melsungen<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

G03GA05 Laboratoires Serono SA Švica<br />

G03GA05 Laboratoires Serono SA Švica<br />

20. 12. 2001 GOPTEN 0,5 mg trandolapril 20 × 0,5 mg C09AA10 Knoll AG, Ludwigshafen, Nemčija<br />

16. 12. 2002 GRANOCYTE 34 lenograstim prebodna steklenička s praškom<br />

(33,6 mio. I.E.) in ampula po 1 ml vode<br />

za injekcije<br />

16. 12. 2002 GRANOCYTE 34 lenograstim 5 prebodnih stekleničk s praškom<br />

(33,6 mio. I.E.) in 5 ampul po 1 ml vode<br />

za injekcije<br />

L03AA10 Rhone Poulenc Rorer<br />

Pharma Specialites<br />

L03AA10 Rhone Poulenc Rorer<br />

Pharma Specialites<br />

2. 4. 2003 GUTRON INJEKCIJE 5 mg/2ml midodrin 5 ampul po 2 ml (5 mg/2 ml) C01CA17 NYCOMED Austria GmbH Avstrija<br />

2. 4. 2003 GUTRON RAZTOPINA 10 mg/<br />

ml<br />

Francija<br />

Francija<br />

midodrin kapalna steklenička po 25 ml (10 mg/ ml) C01CA17 NYCOMED Austria GmbH Avstrija<br />

2. 4. 2003 GUTRON TABLETE 2,5 mg midodrin 20 × 2,5 mg C01CA17 NYCOMED Austria GmbH Avstrija<br />

2. 4. 2003 GUTRON TABLETE 2,5 mg midodrin 50 × 2,5 mg C01CA17 NYCOMED Austria GmbH Avstrija<br />

2. 4. 2003 GUTRON TABLETE 5 mg midodrin 20 × 5 mg C01CA17 NYCOMED Austria GmbH Avstrija<br />

2. 4. 2003 GUTRON TABLETE 5 mg midodrin 50 × 5 mg C01CA17 NYCOMED Austria GmbH Avstrija<br />

7. 3. 2002 GYNO-DAKTARIN vagitoriji mikonazol 7 × 200mg G01AF04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

20. 9. 2004 GYNODIAN DEPOT prasteron zlozˇenka s 3 pretisnimi omoti z<br />

injekcijsko brizgo z vlozˇeno ampulo po<br />

1 ml raztopine in injekcijsko brizgo<br />

7. 3. 2002 HAEMACCEL poligelin zlozˇenka z eno plastenko po 500 ml<br />

raztopine (17,5 g/500 ml)<br />

Slovenija<br />

G03EA03 Schering AG, Berlin, Nemčija<br />

B05AA06 Hoechst Marion Roussel<br />

Deutchland GmbH, Marburg,<br />

Nemčija za H.M.R.<br />

Deutchland GmbH,<br />

Frankfurt<br />

Nemčija<br />

1536 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

23. 10. 2003 HAEMATE P 1000 kombinacija von<br />

Willebrandovega<br />

faktorja in<br />

koagulacijskega<br />

faktorja VIII<br />

23. 10. 2003 HAEMATE P 250 kombinacija von<br />

Willebrandovega<br />

faktorja in<br />

koagulacijskega<br />

faktorja VIII<br />

23. 10. 2003 HAEMATE P 500 kombinacija von<br />

Willebrandovega<br />

faktorja in<br />

koagulacijskega<br />

faktorja VIII<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

zlozˇenka z 1 vialo s praškom, 1 vialo po<br />

30 ml vode za injekcije in priborom za<br />

prenos in aplikacijo<br />

zlozˇenka z 1 vialo s praškom, 1 vialo po<br />

10 ml vode za injekcije in priborom za<br />

prenos in aplikacijo<br />

zlozˇenka z 1 vialo s praškom, 1 vialo po<br />

20 ml vode za injekcije in priborom za<br />

prenos in aplikacijo<br />

B02BD06 Centeon Pharma GmbH,<br />

Marburg<br />

B02BD06 Centeon Pharma GmbH,<br />

Marburg<br />

B02BD06 Centeon Pharma GmbH,<br />

Marburg<br />

28. 6. 2001 HAEMOCOMPLETAN P 1 g humani<br />

fibrinogen<br />

viala po 1 g B02BB01 Behringwerke AG Nemčija<br />

28. 6. 2001 HAEMOCOMPLETAN P 2 g humani<br />

fibrinogen<br />

viala po 2 g B02BB01 Behringwerke AG Nemčija<br />

28. 6. 2001 HAES-STERIL 10% hetaškrob plastenka po 500 ml raztopine B05AA07 Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

Nemčija<br />

12. 3. 2004 HAES-STERIL 6 % hetaškrob plastična vrečka po 500 ml raztopine B05AA07 Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

Nemčija<br />

12. 3. 2004 HAES-STERIL 6 % hetaškrob plastenka po 500 ml raztopine B05AA07 Fresenius Kabi Deutschland<br />

GmbH, Bad Homburg<br />

Nemčija<br />

15. 2. 2004 HALDOL DEPO haloperidol zlozˇenka s 5 ampulami po 1 ml raztopine<br />

(50 mg/ml)<br />

1. 7. 2004 HALDOL peroralne kapljice<br />

10 mg/1 ml<br />

1. 7. 2004 HALDOL peroralne kapljice<br />

2 mg/1 ml<br />

1. 7. 2004 HALDOL raztopina za injiciranje<br />

5 mg/1 ml<br />

haloperidol zlozˇenka s kapalno stekleničko po 30 ml<br />

raztopine<br />

haloperidol zlozˇenka s kapalno stekleničko po 10 ml<br />

raztopine<br />

haloperidol zlozˇenka z 10 ampulami po 1 ml<br />

raztopine<br />

N05AD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

N05AD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

N05AD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

N05AD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

1. 7. 2004 HALDOL tablete 10 mg haloperidol zlozˇenka s stekleničko po 30 tablet N05AD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

1. 7. 2004 HALDOL tablete 2 mg haloperidol zlozˇenka s stekleničko po 25 tablet N05AD01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

sodelovanju z Janssen<br />

Pharmaceutica, Belgija<br />

sodelovanju z Janssen<br />

Pharmaceutica, Belgija<br />

sodelovanju z Janssen<br />

Pharmaceutica, Belgija<br />

sodelovanju z Janssen<br />

Pharmaceutica, Belgija<br />

sodelovanju z Janssen<br />

Pharmaceutica, Belgija<br />

sodelovanju z Janssen<br />

Pharmaceutica, Belgija<br />

7. 3. 2002 HALOTHAN halotan steklenica po 250 ml N01AB01 Hoechst AG, Frankfurt, Nemčija<br />

7. 12. 2003 HAVRIX 1440 prečiščen antigen<br />

virusa hepatitisa<br />

tipa A<br />

škatla z vialo po 1 ml suspenzije (1440<br />

ELISA enot/ml)<br />

J07BC02 SmithKline Beecham<br />

Biologicals s.a., Rixensart,<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Belgija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1537


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 12. 2003 HAVRIX 1440 prečiščen antigen<br />

virusa hepatitisa<br />

tipa A<br />

7. 12. 2003 HAVRIX 720 OTROŠKI prečiščen antigen<br />

virusa hepatitisa<br />

tipa A<br />

7. 12. 2003 HAVRIX 720 OTROŠKI prečiščen antigen<br />

virusa hepatitisa<br />

tipa A<br />

20. 12. 2001 HB VAX II 40 µg prečiščen antigen<br />

virusa hepatitisa<br />

tipa B<br />

20. 12. 2001 HB VAX II 10 µg prečiščen antigen<br />

virusa hepatitisa<br />

tipa B<br />

20. 12. 2001 HB VAX II 5 µg prečiščen antigen<br />

virusa hepatitisa<br />

tipa B<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

zlozˇenka z eno napolnjeno injekcijsko<br />

brizgo po 1 ml suspenzije<br />

škatla z vialo po 0,5 ml suspenzije (720<br />

ELISA enot/0,5 ml)<br />

zlozˇenka z eno napolnjeno injekcijsko<br />

brizgo po 0,5 ml suspenzije<br />

J07BC02 SmithKline Beecham<br />

Biologicals s.a., Rixensart,<br />

J07BC02 SmithKline Beecham<br />

Biologicals s.a., Rixensart,<br />

J07BC02 SmithKline Beecham<br />

Biologicals s.a., Rixensart,<br />

steklenička po 1 ml (40 µg/1ml) J07BC01 MERCK SHARP & DOHME,<br />

Pennsylvania,<br />

steklenička po 1 ml (10 µg/1ml) J07BC01 MERCK SHARP & DOHME,<br />

Pennsylvania,<br />

steklenička po 0,5 ml (5 µg/0,5ml) J07BC01 MERCK SHARP & DOHME,<br />

Pennsylvania,<br />

3. 11. 2003 HELEX alprazolam 30 × 0,25 mg N05BA12 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 HELEX alprazolam 30 × 1 mg N05BA12 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 HELEX alprazolam 30 × 0,5 mg N05BA12 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

30. 5. 2002 HEMOHES 10% hetaškrob 10 steklenic po 500 ml (100g/1000mg) B05AA07 B. Braun Melsungen AG,<br />

Melsungen<br />

30. 5. 2002 HEMOHES 10% hetaškrob plastenka po 500 ml raztopine B05AA07 B. Braun Medical AG,<br />

Crissier, Švica za B. Braun<br />

30. 5. 2002 HEMOHES 6% hetaškrob 10 steklenic po 500 ml (60 g/1000 ml) B05AA07 B. Braun Melsungen AG,<br />

Melsungen<br />

30. 5. 2002 HEMOHES 6% hetaškrob plastenka po 500 ml raztopine B05AA07 B. Braun Medical AG,<br />

Crissier, Švica za B. Braun<br />

12. 4. 2001 HEPAN gel heparin tuba po 50 g B01AB01 Jadran, Galenski laboratorij<br />

d.d., Rijeka, Hrvaška<br />

12. 4. 2001 HEPARIN heparin 1 ampula po 5 ml (25.000 I.E./5ml) B01AB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Melsungen AG,<br />

Melsungen<br />

Melsungen AG,<br />

Melsungen<br />

9. 7. 2003 HEPTANON injekcije metadon 50 ampul po 1 ml (10 mg/ml) N02AC02 Pliva d.d., Zagreb Hrvaška<br />

9. 7. 2003 HEPTANON peroralna raztopina metadon zlozˇenka s stekleničko po 100 ml<br />

raztopine in merilno brizgo za peroralno<br />

dajanje<br />

N02AC02 Pliva d.d., Zagreb Hrvaška<br />

9. 7. 2003 HEPTANON peroralne kapljice metadon steklenička po 10 ml (10 mg/ml) N02AC02 Pliva d.d., Zagreb Hrvaška<br />

Belgija<br />

Belgija<br />

Belgija<br />

ZDA<br />

ZDA<br />

ZDA<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Slovenija<br />

1538 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

9. 7. 2003 HEPTANON tablete metadon 20 × 5 mg N02AC02 Pliva d.d., Zagreb Hrvaška<br />

19. 3. 2004 HIBERIX vezana oblika<br />

očiščenega<br />

antigena<br />

Hemofilus<br />

influence tipa B<br />

zlozˇenka z eno vialo s praškom in eno<br />

vialo po 0,5 ml topila (10 µg/0,5 ml)<br />

J07AG01 SmithKline Beecham<br />

Biologicals s.a., Rixensart,<br />

10. 11. 2002 HICONCIL amoksicilin 16 × 250 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

10. 11. 2002 HICONCIL amoksicilin 100 × 250 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

10. 11. 2002 HICONCIL amoksicilin 100 × 500 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

10. 11. 2002 HICONCIL amoksicilin steklenička s praškom za pripravo 100 ml<br />

suspenzije (250 mg/5 ml)<br />

J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

10. 11. 2002 HICONCIL amoksicilin 16 × 500 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

10. 11. 2002 HICONCIL amoksicilin steklenička s praškom za pripravo 10 ml<br />

suspenzije (100mg/ml)<br />

J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

20. 12. 2001 HOLOXAN 1 g ifosfamid zlozˇenka z 1 vialo s praškom L01AA06 Asta Medica AG, Frankfurt<br />

am Main<br />

20. 12. 2001 HOLOXAN 2 g ifosfamid zlozˇenka z 1 vialo s praškom L01AA06 Asta Medica AG, Frankfurt<br />

am Main<br />

20. 12. 2001 HOLOXAN 500 mg ifosfamid zlozˇenka z 1 vialo s praškom L01AA06 Asta Medica AG, Frankfurt<br />

am Main<br />

21. 5. 2004 HOMOFAN 100 insulin, človeški,<br />

rekombinantni<br />

21. 5. 2004 HOMOLONG 40 insulin, človeški,<br />

rekombinantni<br />

21. 5. 2004 HOMORAP 100 insulin, človeški,<br />

rekombinantni<br />

21. 5. 2004 HOMORAP 40 insulin, človeški,<br />

rekombinantni<br />

zlozˇenka s 5 vlozˇki za injekcijsko pero<br />

po 1,5 ml suspenzije<br />

zlozˇenka s prebodno stekleničko po<br />

10 ml suspenzije<br />

zlozˇenka s 5 vlozˇki za injekcijsko pero<br />

po 1,5 ml raztopine<br />

zlozˇenka s prebodno stekleničko po<br />

10 ml raztopine<br />

12. 4. 2001 HONVAN injekcije fosfestrol zlozˇenka z 10 ampulami po 5 ml<br />

raztopine<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

Belgija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

A10AC01 Pliva d.d., Zagreb Hrvaška<br />

A10AC01 Pliva d.d., Zagreb Hrvaška<br />

A10AB01 Pliva d.d., Zagreb Hrvaška<br />

A10AB01 Pliva d.d., Zagreb Hrvaška<br />

L02AA04 Asta Medica AG, Frankfurt<br />

am Main<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1539


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

12. 4. 2001 HONVAN tablete fosfestrol zlozˇenka s 50 tabletami L02AA04 Asta Medica AG, Frankfurt<br />

am Main<br />

Nemčija<br />

20. 12. 2001 HUMAJECT REGULAR insulin, človeški,<br />

rekombinantni<br />

5 peres po 3 ml (100I.E./1ml) A10AB01 Lilly France S.A., Fegersheim Francija<br />

20. 12. 2001 HUMAJECT M1 (10/90) insulin, človeški,<br />

rekombinantni<br />

5 peres po 3 ml (100I.E./ml) A10AD01 Lilly France S.A., Fegersheim Francija<br />

20. 12. 2001 HUMAJECT M2 (20/80) insulin, človeški,<br />

rekombinantni<br />

5 peres po 3 ml (100I.E./ml) A10AD01 Lilly France S.A., Fegersheim Francija<br />

20. 12. 2001 HUMAJECT M3 (30/70) insulin, človeški,<br />

rekombinantni<br />

5 peres po 3 ml (100 I.E./ml) A10AD01 Lilly France S.A., Fegersheim Francija<br />

20. 12. 2001 HUMAJECT M4 (40/60) insulin, človeški,<br />

rekombinantni<br />

5 peres po 3 ml (100 I.E./ml) A10AD01 Lilly France S.A., Fegersheim Francija<br />

20. 12. 2001 HUMAJECT N NPH insulin, človeški,<br />

rekombinantni<br />

5 peres po 3 ml (100I.E./1ml) A10AC01 Lilly France S.A., Fegersheim Francija<br />

20. 12. 2001 HUMALOG 100 I.E./ml insulin lispro,<br />

rekombinantni<br />

20. 12. 2001 HUMALOG 40 I.E./ml insulin lispro,<br />

rekombinantni<br />

5 vlozˇkov za injekcijsko pero po 1,5 ml<br />

(100 I.E./1ml)<br />

17. 11. 2004 HUMANI ALBUMIN 20 % albumin zlozˇenka z 1 prebodno stekleničko po<br />

50 ml raztopine<br />

17. 11. 2004 HUMANI ALBUMIN 20 % albumin zlozˇenka z 1 prebodno stekleničko po<br />

100 ml raztopine<br />

29. 11. 2004 HUMANI ALBUMIN 5%<br />

IMMUNO<br />

A10AB04 Lilly France S.A., Fegersheim Francija<br />

steklenička po 10 ml (40 I.E./ml) A10AB04 Lilly France S.A., Fegersheim Francija<br />

albumin zlozˇenka s prebodno stekleničko po<br />

250 ml raztopine<br />

B05AA01 Centeon Pharma GmbH,<br />

Marburg, Nemčija za<br />

B05AA01 Centeon Pharma GmbH,<br />

Marburg, Nemčija za<br />

B05AA01 Österreichisches Institut für<br />

Haemoderivate Ges.<br />

Centeon Pharma<br />

GmbH, Dunaj, Avstrija<br />

Centeon Pharma<br />

GmbH, Dunaj, Avstrija<br />

m.b.H., Production<br />

Division of IMMUNO<br />

AG Dunaj<br />

20. 12. 2001 HUMATRO PEN II 18 I.E. 1 injekcijsko pero HUMATRO-PEN II<br />

18 I.E.<br />

Lilly France S.A., Fegersheim Francija<br />

20. 12. 2001 HUMATRO PEN II 36 I.E. 1 injekcijsko pero HUMATRO-PEN II<br />

36 I.E.<br />

Lilly France S.A., Fegersheim Francija<br />

20. 12. 2001 HUMATROPE 18 I.E. somatropin,<br />

rekombinantni<br />

humani<br />

1 vlozˇek po 18 I.E. (0,25 I.E./0,04ml) H01AC01 Lilly France S.A., Fegersheim Francija<br />

20. 12. 2001 HUMATROPE 36 I.E. somatropin,<br />

rekombinantni<br />

humani<br />

12. 1. 2003 HUMEGON menotropinhumani<br />

menopavzni<br />

gonadotropin<br />

20. 12. 2001 HUMULIN N NPH insulin, človeški,<br />

rekombinantni<br />

Avstrija<br />

1 vlo§ek po 36 I.E. (0,50 I.E./0,04ml) H01AC01 Lilly France S.A., Fegersheim Francija<br />

10 ampul s praškom (75 I.E.) in 10<br />

ampul po 1 ml 0,9% raztopine<br />

natrijevega klorida<br />

G03GA02 N. V. Organon, Oss, Nizozemska<br />

5 vlozˇkov po 3 ml (100I.E./1ml) A10AC01 Lilly France S.A., Fegersheim Francija<br />

1540 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

20. 12. 2001 HUMULIN REGULAR insulin, človeški,<br />

rekombinantni<br />

20. 12. 2001 HUMULIN M1 (10/90) insulin, človeški,<br />

rekombinantni<br />

20. 12. 2001 HUMULIN M2 (20/80) insulin, človeški,<br />

rekombinantni<br />

20. 12. 2001 HUMULIN M3 (30/70) insulin, človeški,<br />

rekombinantni<br />

20. 12. 2001 HUMULIN M4 (40/60) insulin, človeški,<br />

rekombinantni<br />

2. 4. 2003 HYALGAN hialuronska<br />

kislina<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

5 vlozˇkov po 3 ml (100 I.E./1ml) A10AB01 Lilly France S.A., Fegersheim Francija<br />

5 vlozˇkov po 3 ml (100I.E./ml) A10AD01 Lilly France S.A., Fegersheim Francija<br />

5 vlozˇkov po 3 ml (100I.E./ml) A10AD01 Lilly France S.A., Fegersheim Francija<br />

5 vlozˇkov po 3 ml (100 I.E./ml) A10AD01 Lilly France S.A., Fegersheim Francija<br />

5 vlozˇkov po 3 ml (100 I.E./ml) A10AD01 Lilly France S.A., Fegersheim Francija<br />

viala po 2 ml (20 mg/2ml) M09AX01 Fidia S.p.A., Abano Terme, Italija<br />

30. 5. 2002 HYZAAR losartan 28 tablet C09DA01 MERCK SHARP & DOHME<br />

B.V., Haarlem<br />

2. 4. 2003 IBADEN 1000 sirup fenoksimetilpenicilin<br />

2. 4. 2003 IBADEN 1000 tablete fenoksimetilpenicilin<br />

2. 4. 2003 IBADEN 1500 tablete fenoksimetilpenicilin<br />

2. 4. 2003 IBADEN 500 tablete fenoksimetilpenicilin<br />

steklenička po 150 ml<br />

(1 000 000 I.E./6 ml)<br />

J01CE02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

30 × 1 000 000 I.E. J01CE02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

30 × 1 500 000 I.E. J01CE02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

30 × 500 000 I.E. J01CE02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

8. 11. 2001 IBUPROFEN drazˇeji 200 mg ibuprofen 30 × 200 mg M01AE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

8. 11. 2001 IBUPROFEN drazˇeji 400 mg ibuprofen 30 × 400mg M01AE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

30. 11. 2005 IBUTOP gel ibuprofen zlozˇenka s tubo po 50 g gela (50 mg/g) M02AA13 Dolorgiet Pharmaceuticals,<br />

St. Augustin, Bonn<br />

Nizozemska<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

10. 11. 2002 ILOMEDIN iloprost 5 ampul po 0,5 ml raztopine B01AC11 Schering AG, Berlin, Nemčija<br />

23. 6. 2003 IMDUR 60 mg izosorbidmononitrat<br />

23. 6. 2003 IMDUR 60 mg izosorbidmononitrat<br />

100 × 60 mg C01DA14 ASTRA, Pharmaceutical<br />

production, Södertälje<br />

30 × 60 mg C01DA14 ASTRA, Pharmaceutical<br />

production, Södertälje<br />

9. 7. 2003 IMIGRAN pršilo za nos sumatriptan zlozˇenka z dvema pršilnikoma po 0,1 ml<br />

raztopine v pretisnem omotu<br />

(20 mg/0,1 ml)<br />

20. 9. 2004 IMIGRAN tablete 100 mg sumatriptan zlozˇenka s 6 tabletami (1 × 6 tablet v<br />

pretisnem omotu)<br />

N02CC01 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

N02CC01 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Export Ltd., Velika<br />

Britanija<br />

Nemčija<br />

Švedska<br />

Švedska<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1541


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

12. 1. 2003 IMIGRAN tablete 50 mg sumatriptan 12 × 50 mg N02CC01 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

18. 1. 2001 IMPORTAL laktitol 20 vrečk po 10 g praška A06AD12 ZYMA S.A., Nyon, Švica<br />

7. 7. 2002 IMURAN azatioprin 100 × 50 mg L04AX01 Glaxo Wellcome Operations,<br />

Greenford<br />

8. 11. 2001 INDERAL 40 mg propranolol 50 × 40 mg C07AA05 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

8. 11. 2001 INDERAL 80 mg propranolol 100 × 80mg C07AA05 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

8. 11. 2001 INDERAL LA propranolol 14 × 160mg C07AA05 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

7. 5. 2004 INFANRIX -cepivo proti davici,<br />

tetanusu in oslovskemu kašlju<br />

(DTPa)<br />

7. 5. 2004 INFANRIX -cepivo proti davici,<br />

tetanusu in oslovskemu kašlju<br />

(DTPa)<br />

cepivo proti<br />

oslovskemu kašlju<br />

zočiščenimi<br />

antigeni in<br />

anatoksini<br />

cepivo proti<br />

oslovskemu kašlju<br />

zočiščenimi<br />

antigeni in<br />

anatoksini<br />

zlozˇenka z eno vialo po 0,5 ml suspenzije J07AJ52 SmithKline Beecham<br />

Biologicals s.a., Rixensart,<br />

zlozˇenka z eno napolnjeno injekcijsko<br />

brizgo po 0,5 ml suspenzije<br />

9. 4. 2004 INFUSOL elektroliti škatla z 10 prebodnimi steklenicami po<br />

500 ml raztopine<br />

19. 3. 2004 INNOHEP tinzaparin zlozˇenka z dvema napolnjenima<br />

injekcijskima brizgama po 0,9 ml<br />

raztopine (20.000 I.E.(anti-Xa)/ml)<br />

19. 3. 2004 INNOHEP tinzaparin zlozˇenka z dvema napolnjenima<br />

injekcijskima brizgama po 0,7 ml<br />

raztopine (20.000 I.E.(anti-Xa)/ml)<br />

19. 3. 2004 INNOHEP tinzaparin zlozˇenka z 10 vialami po 2 ml raztopine<br />

(20.000 I.E. (anti-Xa)/ml)<br />

19. 3. 2004 INNOHEP tinzaparin zlozˇenka z 10 napolnjenimi injekcijskimi<br />

brizgami po 0,45 ml raztopine<br />

(10.000 I.E. (anti-Xa)/ml)<br />

19. 3. 2004 INNOHEP tinzaparin zlozˇenka z 10 napolnjenimi injekcijskimi<br />

brizgami po 0,35 ml raztopine<br />

(10.000 I.E. (anti-Xa)/ml)<br />

19. 3. 2004 INNOHEP tinzaparin zlozˇenka z 10 vialami po 2 ml raztopine<br />

(10.000 I.E. (anti-Xa)/ml)<br />

4. 1. 2004 INOTOP 250 mg dobutamin škatla z ampulo po 20 ml koncentrata<br />

(250 mg/20 ml)<br />

J07AJ52 SmithKline Beecham<br />

Biologicals s.a., Rixensart,<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Belgija<br />

Belgija<br />

B05BB01 Pliva d.d., Zagreb Hrvaška<br />

B01AB10 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

B01AB10 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

B01AB10 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

B01AB10 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

B01AB10 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

B01AB10 LEO Pharmaceutical Products<br />

Ltd., Ballerup,<br />

C01CA07 Pharma Hameln GmbH,<br />

Nemčija za Torrex Pharma<br />

Koppenhagen Danska<br />

Koppenhagen Danska<br />

Koppenhagen Danska<br />

Koppenhagen Danska<br />

Koppenhagen Danska<br />

Koppenhagen Danska<br />

GmbH, Dunaj, Avstrija<br />

1542 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

9. 7. 2003 INSPIRYL TURBUHALER salbutamol vdihovalnik (turbuhaler) za 100 inhalacij<br />

(100 µg/inhalacijo)<br />

9. 7. 2003 INSPIRYL TURBUHALER salbutamol vdihovalnik (turbuhaler) za 200 inhalacij<br />

(50 µg/inhalacijo)<br />

7. 3. 2002 INSULATARD NOVOLET insulin, človeški,<br />

biosintetični<br />

9. 7. 2003 INSULATARD NovoLet<br />

100 IU/ml, 3 ml<br />

insulin, človeški,<br />

biosintetični<br />

30. 5. 2002 INSULATARD PENFILL 3 ml insulin, človeški,<br />

biosintetični<br />

10. 11. 2002 INTAL KAPSULE ZA<br />

INHALACIJO 20 mg<br />

kromoglicinska<br />

kislina<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

5 napolnjenih injekcijskih brizg v obliki<br />

peresa NovoLet po 1,5 ml (150I.E./1,5ml)<br />

5 napolnjenih injekcijskih brizg v obliki<br />

peresa po 3 ml (300 I.E./3ml)<br />

zlozˇenka s 5 karpulami po 3 ml<br />

(100 I.E./ml)<br />

1. 7. 2004 Intravenska raztopina 0,9% NaCl natrijev klorid škatla s 36 vrečkami Clear-Flex po<br />

250 ml raztopine<br />

1. 7. 2004 Intravenska raztopina 0,9% NaCl natrijev klorid škatla s 20 vrečkami Clear-Flex po<br />

500 ml raztopine<br />

1. 7. 2004 Intravenska raztopina 0,9% NaCl natrijev klorid škatla s 12 vrečkami Clear-Flex po<br />

1000 ml raztopine<br />

1. 7. 2004 Intravenska raztopina 0,9% NaCl natrijev klorid škatla s 50 vrečkami Clear-Flex po<br />

100 ml raztopine<br />

1. 7. 2004 Intravenska raztopina 0,9% NaCl natrijev klorid škatla s 50 vrečkami Clear-Flex po 50 ml<br />

raztopine<br />

1. 7. 2004 Intravenska raztopina 10%<br />

glukoze, BP<br />

1. 7. 2004 Intravenska raztopina 5%<br />

glukoze, BP<br />

1. 7. 2004 Intravenska raztopina 5%<br />

glukoze, BP<br />

1. 7. 2004 Intravenska raztopina 5%<br />

glukoze, BP<br />

1. 7. 2004 Intravenska raztopina 5%<br />

glukoze, BP<br />

R03AC02 Astra Pharmaceutical<br />

Production AB za Astra<br />

R03AC02 Astra Pharmaceutical<br />

Production AB za Astra<br />

A10AC01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10AC01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10AC01 Pliva d.d. Zagreb v<br />

sodelovanju z Novo Nordisk<br />

A/S<br />

50 × 20 mg R03BC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

glukoza škatla z 20 plastičnimi vrečkami<br />

Clear-Flex po 500 ml raztopine<br />

glukoza škatla s 50 plastičnimi vrečkami<br />

Clear-Flex po 100 ml raztopine<br />

glukoza škatla s 36 plastičnimi vrečkami<br />

Clear-Flex po 250 ml raztopine<br />

glukoza škatla z 20 plastičnimi vrečkami<br />

Clear-Flex po 500 ml raztopine<br />

glukoza škatla z 12 plastičnimi vrečkami<br />

Clear-Flex po 1000 ml raztopine<br />

B05BB01 Bieffe Medital S.p.A., Italija<br />

ali Bieffe Medital<br />

B05BB01 Bieffe Medital S.p.A., Italija<br />

ali Bieffe Medital<br />

B05BB01 Bieffe Medital S.p.A., Italija<br />

ali Bieffe Medital<br />

B05BB01 Bieffe Medital S.p.A., Italija<br />

ali Bieffe Medital<br />

B05BB01 Bieffe Medital S.A.,<br />

Sabinanigo, Španija za Baxter<br />

B05BA03 Bieffe Medital S.p.A., Italija<br />

ali Bieffe Medital<br />

B05BA03 Bieffe Medital S.p.A., Italija<br />

ali Bieffe Medital<br />

B05BA03 Bieffe Medital S.p.A., Italija<br />

ali Bieffe Medital<br />

B05BA03 Bieffe Medital S.p.A., Italija<br />

ali Bieffe Medital<br />

B05BA03 Bieffe Medital S.p.A., Italija<br />

ali Bieffe Medital<br />

Export & Trading AB,<br />

Södertälje<br />

Export & Trading AB,<br />

Södertälje<br />

Danska<br />

Švedska<br />

Švedska<br />

Danska<br />

Danska<br />

d.d., Ljubljana Slovenija<br />

S.A., Španija za Baxter<br />

Export Corporation,<br />

Miami<br />

S.A., Španija za Baxter<br />

Export Corporation,<br />

Miami<br />

S.A., Španija za Baxter<br />

Export Corporation,<br />

Miami<br />

S.A., Španija za Baxter<br />

Export Corporation,<br />

Miami<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

S.A., Španija za Baxter<br />

Export Corporation,<br />

Miami<br />

S.A., Španija za Baxter<br />

Export Corporation,<br />

Miami<br />

S.A., Španija za Baxter<br />

Export Corporation,<br />

Miami<br />

S.A., Španija za Baxter<br />

Export Corporation,<br />

Miami<br />

S.A., Španija za Baxter<br />

Export Corporation,<br />

Miami<br />

ZDA<br />

ZDA<br />

ZDA<br />

ZDA<br />

ZDA<br />

ZDA<br />

ZDA<br />

ZDA<br />

ZDA<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1543


Datum<br />

veljavnosti<br />

Ime zdravila<br />

1. 7. 2004 Intravenska raztopina 5%<br />

glukoze, BP<br />

mednarodno<br />

nelastniško ime<br />

1. 10. 2004 INTRON A interferon alfa-2b,<br />

rekombinantni<br />

7. 5. 2004 INTRON A 30 MIE interferon alfa-2b,<br />

rekombinantni<br />

7. 5. 2004 INTRON A 60 MIE interferon alfa-2b,<br />

rekombinantni<br />

7. 5. 2004 INTRON A 18 MIE interferon alfa-2b,<br />

rekombinantni<br />

glukoza škatla s 50 plastičnimi vrečkami<br />

Clear-Flex po 50 ml raztopine<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

zlozˇenka z eno vialo s praškom (3 M I.E.),<br />

ampulo po 1 ml vode za injekcije in<br />

priborom za injiciranje<br />

zlozˇenka z eno napolnjeno injekcijsko<br />

brizgo v obliki peresa in priborom za<br />

aplikacijo (30 MIE/brizgo)<br />

zlozˇenka z eno napolnjeno injekcijsko<br />

brizgo v obliki peresa in priborom za<br />

aplikacijo (60 MIE/brizgo)<br />

zlozˇenka z eno napolnjeno injekcijsko<br />

brizgo v obliki peresa in priborom za<br />

aplikacijo (18 MIE/brizgo)<br />

B05BA03 Bieffe Medital S.A.,<br />

Sabinanigo, Španija za Baxter<br />

L03AB05 Schering-Plough (Brinny),<br />

Co., Irska in Schering-<br />

L03AB05 Schering-Plough (Brinny)<br />

N.V. Innishannon (Country<br />

Cork),<br />

L03AB05 Schering-Plough (Brinny)<br />

N.V. Innishannon (Country<br />

Cork),<br />

L03AB05 Schering-Plough (Brinny)<br />

N.V. Innishannon (Country<br />

Cork),<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Plough Labo N.V.,<br />

Belgija za Schering-<br />

Plough CE AG<br />

Irska za Schering<br />

Plough Labo N.V.,<br />

Belgija<br />

Irska za Schering<br />

Plough Labo N.V.,<br />

Belgija<br />

Irska za Schering<br />

Plough Labo N.V.,<br />

Belgija<br />

7. 7. 2002 INVIRASE sakvinavir 270 × 200 mg J05AE01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

Švica<br />

21. 12. 2004 IOMERON 250 jomeprol zlozˇenka s stekleničko po 250 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

21. 12. 2004 IOMERON 250 jomeprol zlozˇenka s stekleničko po 50 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

21. 12. 2004 IOMERON 250 jomeprol zlozˇenka s stekleničko po 100 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

21. 12. 2004 IOMERON 300 jomeprol zlozˇenka s stekleničko po 50 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

21. 12. 2004 IOMERON 300 jomeprol zlozˇenka s stekleničko po 75 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

21. 12. 2004 IOMERON 300 jomeprol zlozˇenka s stekleničko po 100 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

21. 12. 2004 IOMERON 300 jomeprol zlozˇenka s stekleničko po 200 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

21. 12. 2004 IOMERON 350 jomeprol zlozˇenka s stekleničko po 50 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

21. 12. 2004 IOMERON 350 jomeprol zlozˇenka s stekleničko po 250 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

21. 12. 2004 IOMERON 350 jomeprol zlozˇenka s stekleničko po 100 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

21. 12. 2004 IOMERON 350 jomeprol zlozˇenka s stekleničko po 200 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

21. 12. 2004 IOMERON 400 jomeprol zlozˇenka s stekleničko po 50 ml<br />

raztopine<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

Švica<br />

1544 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

21. 12. 2004 IOMERON 400 jomeprol zlozˇenka s stekleničko po 100 ml<br />

raztopine<br />

21. 12. 2004 IOMERON 400 jomeprol zlozˇenka s stekleničko po 200 ml<br />

raztopine<br />

2. 6. 2005 IPERTROFAN 40 mepartricin zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

dvojnem traku)<br />

23. 10. 2003 ISO MACK Retard 20 mg izosorbiddinitrat zlozˇenka s 50 kapsulami (5 × 10 kapsul v<br />

pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

V08AB10 Bracco S.p.A., Milano Italija<br />

G04CX03 SPA — Societa Prodotti<br />

Antibiotici S.p.A., Milano<br />

C01DA08 Heinrich Mack Nachf. GmbH<br />

& Co. KG,ein Unternehmen<br />

3. 11. 2003 ISOFLURAN izofluran steklenička po 250 ml N01AB06 Rhone-Poulenc Chemicals<br />

Ltd.<br />

3. 11. 2003 ISOFLURAN izofluran steklenička po 100 ml N01AB06 Rhone-Poulenc Chemicals<br />

Ltd.<br />

9. 4. 2004 ISOPTIN injekcije verapamil zlozˇenka s 50 ampulami po 2 ml<br />

raztopine<br />

9. 4. 2004 ISOPTIN RR tablete verapamil zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

9. 4. 2004 ISOPTIN tablete 120 mg verapamil zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

9. 4. 2004 ISOPTIN tablete 40 mg verapamil zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

9. 4. 2004 ISOPTIN tablete 80 mg verapamil zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

19. 3. 2004 ISOPTO CARBAHOL 1,5 % karbahol zlozˇenka s kapalno plastenko po 15 ml<br />

raztopine<br />

19. 3. 2004 ISOPTO CARBAHOL 3% karbahol zlozˇenka s kapalno plastenko po 15 ml<br />

raztopine<br />

24. 6. 2004 ISOPTO TEARS hipromeloza zlozˇenka s kapalno plastenko po 15 ml<br />

raztopine<br />

12. 3. 2004 Izotonična raztopina natrijevega<br />

klorida 0,9 % Braun<br />

12. 3. 2004 Izotonična raztopina natrijevega<br />

klorida 0,9 % Braun<br />

12. 3. 2004 Izotonična raztopina natrijevega<br />

klorida 0,9 % Braun<br />

12. 3. 2004 Izotonična raztopina natrijevega<br />

klorida 0,9 % Braun<br />

12. 3. 2004 Izotonična raztopina natrijevega<br />

klorida 0,9 % Braun<br />

natrijev klorid polietilenska plastenka (PLASCO) po<br />

100 ml raztopine<br />

natrijev klorid polietilenska plastenka (PLASCO) po<br />

250 ml raztopine<br />

natrijev klorid polietilenska plastenka (PLASCO) po<br />

500 ml raztopine<br />

natrijev klorid polietilenska plastenka (PLASCO) po<br />

1000 ml raztopine<br />

natrijev klorid zlozˇenka z 20 polietilenskimi ampulami<br />

(Mini-Plasco) po 20 ml raztopine<br />

C08DA01 Pliva d.d., Zagreb, Hrvaška v<br />

sodelovanju s<br />

C08DA01 Pliva d.d., Zagreb, Hrvaška v<br />

sodelovanju s<br />

C08DA01 Pliva d.d., Zagreb, Hrvaška v<br />

sodelovanju s<br />

C08DA01 Pliva d.d., Zagreb, Hrvaška v<br />

sodelovanju s<br />

C08DA01 Pliva d.d., Zagreb, Hrvaška v<br />

sodelovanju s<br />

S01EB02 S.A. Alcon-Couvreur N.V.,<br />

Puurs, Belgija za Alcon<br />

S01EB02 S.A. Alcon-Couvreur N.V.,<br />

Puurs, Belgija za Alcon<br />

S01XA20 S.A. Alcon-Couvreur N.V.,<br />

Puurs, Belgija za Alcon<br />

B05BB01 B. Braun Melsungen AG,<br />

Melsungen<br />

B05BB01 B. Braun Melsungen AG,<br />

Melsungen<br />

B05BB01 B. Braun Melsungen AG,<br />

Melsungen<br />

B05BB01 B. Braun Melsungen AG,<br />

Melsungen<br />

B05BB01 B. Braun Melsungen AG,<br />

Melsungen<br />

der Pfizer Gruppe,<br />

Illertissen<br />

Knoll AG,<br />

Ludwigshafen, Nemčija<br />

Knoll AG,<br />

Ludwigshafen, Nemčija<br />

Knoll AG,<br />

Ludwigshafen, Nemčija<br />

Knoll AG,<br />

Ludwigshafen, Nemčija<br />

Knoll AG,<br />

Ludwigshafen, Nemčija<br />

Pharmaceuticals Ltd.,<br />

Hünenberg, Švica<br />

Pharmaceuticals Ltd.,<br />

Hünenberg, Švica<br />

Pharmaceuticals Ltd.,<br />

Hünenberg, Švica<br />

Italija<br />

Nemčija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1545


Datum<br />

veljavnosti<br />

Ime zdravila<br />

12. 3. 2004 Izotonična raztopina natrijevega<br />

klorida 0,9 % Braun<br />

28. 6. 2001 Izotonična raztopina natrijevega<br />

klorida 0,9 % Braun za infuzijo<br />

28. 6. 2001 Izotonična raztopina natrijevega<br />

klorida 0,9 % Braun za infuzijo<br />

28. 6. 2001 Izotonična raztopina natrijevega<br />

klorida 0,9 % Braun za infuzijo<br />

28. 6. 2001 Izotonična raztopina natrijevega<br />

klorida 0,9 % Braun za infuzijo<br />

28. 6. 2001 IZOTONIČNA RAZTOPINA<br />

NATRIJEVEGA KLORIDA 0,9%<br />

BRAUN za izpiranje<br />

28. 6. 2001 IZOTONIČNA RAZTOPINA<br />

NATRIJEVEGA KLORIDA 0,9%<br />

BRAUN za izpiranje<br />

mednarodno<br />

nelastniško ime<br />

natrijev klorid zlozˇenka z 20 polietilenskimi ampulami<br />

(Mini-Plasco) po 10 ml raztopine<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

B05BB01 B. Braun Melsungen AG,<br />

Melsungen<br />

natrijev klorid plastična vrečka po 1000 ml raztopine B05BB01 B. Braun Schiwa GmbH &<br />

Co. KG, Glandorf, Nemčija<br />

natrijev klorid plastična vrečka po 500 ml raztopine B05BB01 B. Braun Schiwa GmbH &<br />

Co. KG, Glandorf, Nemčija<br />

natrijev klorid plastična vrečka po 250 ml raztopine B05BB01 B. Braun Schiwa GmbH &<br />

Co. KG, Glandorf, Nemčija<br />

natrijev klorid plastična vrečka po 2000 ml raztopine B05BB01 B. Braun Schiwa GmbH &<br />

Co. KG, Glandorf, Nemčija<br />

natrijev klorid plastenka po 1000 ml (0,9 g/100 ml) B05CB01 B. Braun Melsungen AG,<br />

Melsungen<br />

natrijev klorid plastenka po 500 ml (0,9g/100ml) B05CB01 B. Braun Melsungen AG,<br />

Melsungen<br />

za B. Braun Melsungen<br />

AG, Melsungen<br />

za B. Braun Melsungen<br />

AG, Melsungen<br />

za B. Braun Melsungen<br />

AG, Melsungen<br />

za B. Braun Melsungen<br />

AG, Melsungen<br />

2. 6. 2005 JODID 100 µg kalijev jodid zlozˇenka s 100 tabletami (4 × 25 tablet v<br />

pretisnem omotu)<br />

H03CA MERCK KGaA, Darmstadt, Nemčija<br />

1. 10. 2004 KALCIJEV KARBONAT tablete 1g kalcijev karbonat zlozˇenka s stekleničko po 50 tablet A12AA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

7. 7. 2002 KALICOR kapsule 400 mg piracetam 30 × 400 mg N06BX03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

5. 6. 2005 KALICOR tablete 800 mg piracetam zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

N06BX03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

d.d., Ljubljana Slovenija<br />

28. 6. 2001 KALII CHLORIDI TABLETTAE kalijev klorid 20 × 500 mg A12BA01 Lekarna Ljubljana, PE<br />

Galenski laboratorij,<br />

Ljubljana Slovenija<br />

9. 7. 2003 KALIJEV JODID tablete 65 mg kalijev jodid 30 × 65 mg V03AB21 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

9. 7. 2003 KALIJEV JODID tablete 65 mg kalijev jodid zlozˇenka s 4 tabletami V03AB21 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

1. 10. 2004 KALINOR šumeče tablete kalijev citrat zlozˇenka s plastičnim vsebnikom po 15<br />

šumečih tablet<br />

A12BA Knoll AG, Ludwigshafen, Nemčija<br />

9. 4. 2004 KALORIČNA RAZTOPINA LGX<br />

24 %<br />

9. 4. 2004 KALORIČNA RAZTOPINA LGX<br />

40 %<br />

ogljikovi hidrati zlozˇenka z 10 prebodnimi steklenicami<br />

po 500 ml raztopine<br />

ogljikovi hidrati zlozˇenka z 10 prebodnimi steklenicami<br />

po 500 ml raztopine<br />

B05BA03 Pliva d.d., Zagreb Hrvaška<br />

B05BA03 Pliva d.d., Zagreb Hrvaška<br />

9. 7. 2003 KAMIREN doksazosin 20 × 1 mg C02CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 KAMIREN doksazosin 20 × 2 mg C02CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

Slovenija<br />

1546 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

9. 7. 2003 KAMIREN doksazosin 20 × 4 mg C02CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 KAPANOL 100 mg morfin 20 × 100 mg N02AA01 Glaxo Wellcome Australia<br />

Pty. Ltd., Victoria,<br />

28. 6. 2001 KAPANOL 20 mg morfin 20 × 20 mg N02AA01 Glaxo Wellcome Australia<br />

Ltd., Boronia<br />

28. 6. 2001 KAPANOL 50 mg morfin 20 × 50 mg N02AA01 Glaxo Wellcome Australia<br />

Ltd., Boronia<br />

1. 10. 2004 KAPTOPRIL tablete 12,5 mg kaptopril zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

1. 10. 2004 KAPTOPRIL tablete 25 mg kaptopril zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

1. 10. 2004 KAPTOPRIL tablete 50 mg kaptopril zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

10. 11. 2002 KARMI KBD 350 CA dvojna<br />

vrečka za kri<br />

10. 11. 2002 KARMI KBD 450 CA dvojna<br />

vrečka za kri<br />

10. 11. 2002 KARMI KBS 350 CA enojna<br />

vrečka za kri<br />

10. 11. 2002 KARMI KBS 450 CA enojna<br />

vrečka za kri<br />

10. 11. 2002 KARMI KBT 350 CAP trojna<br />

vrečka za kri<br />

10. 11. 2002 KARMI KBT 350 CSMP trojna<br />

vrečka za kri<br />

10. 11. 2002 KARMI KBT 450 CAP trojna<br />

vrečka za kri<br />

10. 11. 2002 KARMI KBT 450 CSMP trojna<br />

vrečka za kri<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

5 dvojnih vrečk s CPDA-1 za 350 ml krvi<br />

(primarna vrečka velikosti 350 ml in<br />

satelitska vrečka velikosti 300 ml)<br />

5 dvojnih vrečk s CPDA-1 za 450 ml krvi<br />

(primarna vrečka velikosti 450 ml in<br />

satelitska vrečka velikosti 300 ml)<br />

C09AA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

C09AA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

C09AA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Avstralija za Glaxo<br />

Wellcome Export Ltd.<br />

Slovenija<br />

Velika<br />

Britanija<br />

Avstralija<br />

Avstralija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

V07AC Kawasumi Laboratories Inc. Japonska<br />

V07AC Kawasumi Laboratories Inc. Japonska<br />

5 enojnih vrečk s CPDA-1 za 350 ml krvi V07AC Kawasumi Laboratories Inc. Japonska<br />

5 enojnih vrečk s CPDA-1 za 450 ml krvi V07AC Kawasumi Laboratories Inc. Japonska<br />

5 trojnih vrečk s CPDA-1 za 350 ml krvi<br />

(primarna vrečka velikosti 350 ml in<br />

satelitski vrečki velikosti 300 ml)<br />

5 trojnih vrečk s CPD in SAGM za<br />

350 ml krvi (primarna vrečka velikosti<br />

350 ml in satelitski vrečki velikosti<br />

300 ml)<br />

5 trojnih vrečk s CPDA-1 za 450 ml krvi<br />

(primarna vrečka velikosti 450 ml in dve<br />

satelitski vrečki velikosti 300 ml)<br />

5 trojnih vrečk s CPD in SAGM za<br />

450 ml krvi (primarna vrečka velikosti<br />

450 ml in satelitski vrečki velikosti<br />

300 ml)<br />

V07AC Kawasumi Laboratories Inc. Japonska<br />

V07AC Kawasumi Laboratories Inc. Japonska<br />

V07AC Kawasumi Laboratories Inc. Japonska<br />

V07AC Kawasumi Laboratories Inc. Japonska<br />

11. 2. 2003 KATALIP 250 mg KAPSULE fenofibrat 30 × 250 mg C10AB05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1547


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

9. 7. 2003 KENALOG triamcinolon 50 × 4 mg H02AB08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

9. 7. 2003 KENALOG 40 triamcinolon 5 ampul po 1 ml (40 mg/ml) H02AB08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

28. 6. 2001 KETANEST 10 ketamin zlozˇenka s 5 prebodnimi stekleničkami<br />

po 20 ml raztopine (200 mg/20 ml)<br />

28. 6. 2001 KETANEST 10 ketamin zlozˇenka z 10 ampulami po 5 ml<br />

raztopine (50 mg/5 ml)<br />

28. 6. 2001 KETANEST 50 ketamin zlozˇenka s 5 prebodnimi stekleničkami<br />

po 10 ml raztopine (500 mg/10 ml)<br />

28. 6. 2001 KETANEST 50 ketamin zlozˇenka z 10 ampulami po 2 ml<br />

raztopine (100 mg/2 ml)<br />

18. 12. 2003 KETOCEF injekcije 1,5 g cefuroksim zlozˇenka s 5 prebodnimi stekleničkami s<br />

praškom<br />

18. 12. 2003 KETOCEF injekcije 750 mg cefuroksim zlozˇenka s 5 prebodnimi stekleničkami s<br />

praškom<br />

2. 4. 2003 KETONAL FORTE tablete<br />

100 mg<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

N01AX03 Parke-Davis GmbH, Berlin Nemčija<br />

N01AX03 Parke-Davis GmbH, Berlin Nemčija<br />

N01AX03 Parke-Davis GmbH, Berlin Nemčija<br />

N01AX03 Parke-Davis GmbH, Berlin Nemčija<br />

J01DA06 Pliva d.d., Zagreb Hrvaška<br />

J01DA06 Pliva d.d., Zagreb Hrvaška<br />

ketoprofen 20 × 100 mg M01AE03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

24. 6. 2005 KETONAL injekcije 100 mg/2 ml ketoprofen zlozˇenka s 50 ampulami po 2 ml<br />

raztopine<br />

24. 6. 2005 KETONAL injekcije 100 mg/2 ml ketoprofen zlozˇenka z 10 ampulami po 2 ml<br />

raztopine<br />

M01AE03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

M01AE03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 KETONAL kapsule 50 mg ketoprofen 25 × 50 mg M01AE03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

24. 6. 2005 KETONAL krema 5 % ketoprofen zlozˇenka s tubo po 100 g kreme M02AA10 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

24. 6. 2005 KETONAL krema 5 % ketoprofen zlozˇenka s tubo po 30 g kreme M02AA10 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 KETONAL krema 50 mg/g ketoprofen tuba po 50 g (50 mg/g) M02AA10 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 KETONAL RETARD tablete<br />

150 mg<br />

ketoprofen 20 × 150 mg M01AE03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 KETONAL svečke 100 mg ketoprofen 12 × 100 mg M01AE03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

19. 3. 2004 KLACID 250 mg klaritromicin zlozˇenka z 10 tabletami ( 1 × 10 tablet v<br />

pretisnem omotu)<br />

19. 3. 2004 KLACID 250 mg klaritromicin zlozˇenka s 14 tabletami ( 1 × 14 tablet v<br />

pretisnem omotu)<br />

J01FA09 Abbott SpA, Campoverde<br />

Aprilia, Italija, za Abbott<br />

J01FA09 Abbott SpA, Campoverde<br />

Aprilia, Italija, za Abbott<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Laboratoires SA, Baar,<br />

Švica<br />

Laboratoires SA, Baar,<br />

Švica<br />

1548 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

19. 3. 2004 KLACID zrnca za pripravo<br />

suspenzije 125 mg/5 ml<br />

mednarodno<br />

nelastniško ime<br />

klaritromicin zlozˇenka s plastičnim vsebnikom z zrnci<br />

za pripravo 60 ml suspenzije<br />

(125 mg/5 ml) in plastično merilno zˇličko<br />

24. 6. 2004 KLIMICIN injekcije 300 mg/2 ml klindamicin zlozˇenka z 10 ampulami po 2 ml<br />

raztopine<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

J01FA09 Abbott SpA, Campoverde<br />

Aprilia, Italija, za Abbott<br />

J01FF01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

24. 6. 2004 KLIMICIN injekcije 600 mg/4 ml klindamicin zlozˇenka z 10 vialami po 4 ml raztopine J01FF01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

24. 6. 2004 KLIMICIN kapsule 150 mg klindamicin zlozˇenka s steklenim vsebnikom po 16<br />

kapsul<br />

24. 6. 2004 KLIMICIN kapsule 300 mg klindamicin zlozˇenka s steklenim vsebnikom po 16<br />

kapsul<br />

24. 6. 2004 KLIMICIN T dermalna raztopina<br />

1%<br />

J01FF01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01FF01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

klindamicin zlozˇenka s plastenko po 30 ml raztopine D10AF01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

24. 6. 2004 KLIMICIN T gel 1% klindamicin zlozˇenka s tubo po 30 g gela D10AF01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 KLIOGEST estradiol 28 tablet G03FA01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

7. 3. 2002 KNAVON kapsule ketoprofen 25 × 50 mg M01AE03 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

7. 3. 2002 KNAVON kapsule ketoprofen 100 × 50 mg M01AE03 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

7. 3. 2002 KNAVON FORTE ketoprofen 20 × 100 mg M01AE03 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

7. 3. 2002 KNAVON kapsule ketoprofen 50 × 50 mg M01AE03 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

7. 3. 2002 KNAVON svečke ketoprofen 12 × 100 mg M01AE03 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

Laboratoires SA, Baar,<br />

Švica<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

28. 6. 2001 KOFAN instant propifenazon zlozˇenka s 1000 tabletami N02BE51 Bosnalijek, Sarajevo Bosna in<br />

Hercegovina<br />

28. 6. 2001 KOFAN instant propifenazon zlozˇenka z 20 tabletami N02BE51 Bosnalijek, Sarajevo Bosna in<br />

Hercegovina<br />

10. 11. 2002 KOMPENSAN dihidroksialuminijev<br />

natrijev karbonat<br />

Danska<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

20 tablet A02AB04 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

7. 7. 2002 KONAKION MM fitomenadion 5 ampul po 1 ml (10mg/1ml) B02BA01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

Švica<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1549


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 7. 2002 KONAKION MM PEDIATRIC fitomenadion 5 ampul po 0,2 ml (2 mg / 0,2 ml) in<br />

plastizna brizga za peroralno dajanje<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

B02BA01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

7. 7. 2002 KONAKION MM PEDIATRIC fitomenadion 5 ampul po 0,2 ml (2 mg / 0,2 ml) B02BA01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

2. 4. 2003 KREON 10 000 (pankreatin) 100 × 150 mg A09AA02 Solvay Pharmaceuticals<br />

GmbH, Hannover,<br />

2. 4. 2003 KREON 10 000 (pankreatin) 20 × 150 mg A09AA02 Solvay Pharmaceuticals<br />

GmbH, Hannover,<br />

2. 4. 2003 KREON 10 000 (pankreatin) 50 × 150 mg A09AA02 Solvay Pharmaceuticals<br />

GmbH, Hannover,<br />

2. 4. 2003 KREON 25 000 (pankreatin) 100 × 300 mg A09AA02 Solvay Pharmaceuticals<br />

GmbH, Hannover,<br />

2. 4. 2003 KREON 25 000 (pankreatin) 20 × 300 mg A09AA02 Solvay Pharmaceuticals<br />

GmbH, Hannover,<br />

2. 4. 2003 KREON 25 000 (pankreatin) 50 × 300 mg A09AA02 Solvay Pharmaceuticals<br />

GmbH, Hannover,<br />

16. 12. 2002 KROMOLIN aerosol 5 mg kromoglicinska<br />

kislina<br />

28. 6. 2001 KROMOLIN kapljice za oko<br />

40mg/1ml<br />

16. 12. 2002 KROMOLIN raztopina za<br />

inhaliranje 20 mg/2 ml<br />

kromoglicinska<br />

kislina<br />

kromoglicinska<br />

kislina<br />

vdihovalnik z inhalacijsko suspenzijo pod<br />

tlakom za 112 inhalacij<br />

steklenička po 10 ml raztopine<br />

(40mg/1ml)<br />

3. 11. 2003 KUTERID G krema betametazon tuba po 15 g (1g kreme vsebuje 0,5 mg<br />

betametazona, 1 mg gentamicina)<br />

3. 11. 2003 KUTERID G mazilo betametazon tuba po 15 g (1g mazila vsebuje 0,5 mg<br />

betametazona, 1 mg gentamicina)<br />

R03BC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

S01GX01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

50 ampul po 2 ml (20 mg/2 ml) R03BC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

D07CC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

D07CC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 KUTERID krema 0,05% betametazon plastični vsebnik po 1 kg (0,5 mg/g) D07AC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 KUTERID krema 0,05% betametazon tuba po 20 g (0,5 mg/g) D07AC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 KUTERID mazilo 0,05% betametazon tuba po 20 g (0,5 mg/g) D07AC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 KUTERID mazilo 0,05% betametazon plastični vsebnik po 1 kg (0,5 mg/g) D07AC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

17. 12. 2004 KUTERID S mazilo betametazon zlozˇenka s tubo po 30 g mazila D07XC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

17. 12. 2004 KUTERID S raztopina betametazon zlozˇenka s plastenko po 30 ml raztopine D07XC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Švica<br />

Švica<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

1550 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

9. 7. 2003 KUTERID tablete 0,5 mg betametazon 30 × 0,5 mg H02AB01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

17. 11. 2004 KYBERNIN P 1000 antitrombin zlozˇenka z eno vialo s praškom, eno vialo<br />

po 20 ml vode za injekcije in sterilnim<br />

setom za raztapljanje<br />

17. 11. 2004 KYBERNIN P 500 antitrombin zlozˇenka z eno vialo s praškom, eno vialo<br />

po 10 ml vode za injekcije in sterilnim<br />

setom za raztapljanje<br />

1. 7. 2004 LACIPIL lacidipin zlozˇenka s 14 tabletami (2 × 7 tablet v<br />

pretisnem omotu)<br />

B01AB02 Centeon Pharma GmbH,<br />

Marburg, Nemčija za<br />

B01AB02 Centeon Pharma GmbH,<br />

Marburg, Nemčija za<br />

C08CA09 Glaxo Wellcome S.A.,<br />

Aranda de Duero, Španija, za<br />

d.d., Ljubljana Slovenija<br />

Centeon Pharma<br />

GmbH, Dunaj, Avstrija<br />

Centeon Pharma<br />

GmbH, Dunaj, Avstrija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

28. 6. 2001 LACORT 10 mg kapsule klorazepat 30 × 10 mg N05BA05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

28. 6. 2001 LACORT 5 mg kapsule klorazepat 30 × 5 mg N05BA05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

30. 5. 2002 LACRYVISC karbomer tuba po 10 g gela (3mg/1g) S01XA20 S.A. Alcon Couvreur N.V.,<br />

Puurs<br />

Belgija<br />

9. 4. 2004 LADIOMIL injekcije maprotilin zlozˇenka z 10 ampulami po 2 ml<br />

raztopine (25 mg/2 ml)<br />

N06AA21 Pliva d.d., Zagreb Hrvaška<br />

9. 4. 2004 LADIOMIL tablete 25 mg maprotilin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

N06AA21 Pliva d.d., Zagreb Hrvaška<br />

9. 4. 2004 LADIOMIL tablete 50 mg maprotilin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

N06AA21 Pliva d.d., Zagreb Hrvaška<br />

12. 4. 2001 LAMICTAL 100 mg lamotrigin 30 × 100 mg N03AX09 Glaxo Wellcome Operations,<br />

Greenford<br />

12. 4. 2001 LAMICTAL 25 mg lamotrigin 30 × 25 mg N03AX09 Glaxo Wellcome Operations,<br />

Greenford<br />

12. 4. 2001 LAMICTAL 50 mg lamotrigin 30 × 50 mg N03AX09 Glaxo Wellcome Operations,<br />

Greenford<br />

2. 6. 2005 LAMICTAL disperzibilne/zˇvečljive<br />

tablete 5 mg<br />

lamotrigin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

4. 1. 2004 LAMISIL dermalna raztopina terbinafin škatla s plastenko po 30 ml raztopine<br />

(10 mg/g) z zaporko s kapalko<br />

4. 1. 2004 LAMISIL dermalno pršilo terbinafin škatla s plastenko po 30 ml raztopine<br />

(10 mg/g) z zaporko s pršilnim ventilom<br />

N03AX09 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

D01AE15 Novartis Pharma S.A.,<br />

Huningue, Francija za<br />

D01AE15 Novartis Pharma S.A.,<br />

Huningue, Francija za<br />

7. 5. 2004 LAMISIL krema 1 % terbinafin zlozˇenka s tubo po 15 g kreme D01AE15 Novartis Pharma GmbH,<br />

Wehr, Nemčija za<br />

3. 7. 2003 LAMISIL tablete 125 mg terbinafin zlozˇenka s 14 tabletami (1× 14 tablet v<br />

pretisnem omotu)<br />

D01BA02 Novartis Pharmaceuticals UK<br />

Ltd., Horsham, Velika<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Novartis Pharma AG,<br />

Basel, Švica<br />

Novartis Pharma AG,<br />

Basel, Švica<br />

Novartis Pharma AG,<br />

Basel, Švica<br />

Britanija za Novartis<br />

Pharma AG, Basel,<br />

Švica<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1551


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

3. 7. 2003 LAMISIL tablete 250 mg terbinafin zlozˇenka s 14 tabletami (1 × 14 tablet v<br />

pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

D01BA02 Novartis Pharmaceuticals UK<br />

Ltd., Horsham, Velika<br />

19. 3. 2004 LANICOR injekcije digoksin zlozˇenka z 10 ampulami po 1 ml<br />

raztopine (0,25 mg/ml)<br />

19. 3. 2004 LANICOR tablete digoksin zlozˇenka po 20 tablet po 0,25 mg (2 ×<br />

10 tablet v pretisnem o omotu)<br />

18. 12. 2003 LANITOP injekcije metildigoksin zlozˇenka z 10 ampulami po 2 ml<br />

raztopine<br />

7. 7. 2002 LANVIS tiogvanin 25 × 40 mg L01BB03 Glaxo Wellcome Operations,<br />

Greenford<br />

10. 7. 2005 LANZUL S kapsule 15 mg lansoprazol zlozˇenka z 28 kapsulami (4 × 7 kapsul v<br />

pretisnem omotu)<br />

Britanija za Novartis<br />

Pharma AG, Basel,<br />

Švica<br />

C01AA05 Pliva d.d., Zagreb Hrvaška<br />

C01AA05 Pliva d.d., Zagreb Hrvaška<br />

C01AA08 Pliva d.d., Zagreb Hrvaška<br />

A02BC03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 LASONIL heparinoid Bayer tuba po 40 g C05BA51 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

3. 11. 2003 LASONIL N heparinoid Bayer tuba po 40 g (5000 HDB enot<br />

heparinoida Bayer/100 g)<br />

16. 12. 2002 LEGOFER zˇelezov protein<br />

sukcinilat<br />

12. 7. 2005 LEKADOL plus C paracetamol zlozˇenka z 10 vrečkami po 5 g zrnc<br />

(500 mg paracetamola +300 mg<br />

askorbinske kisline/5 g)<br />

7. 3. 2002 LEKADOL sirup paracetamol zlozˇenka s stekleničko po 120 ml sirupa<br />

in merilno zˇličko<br />

C05BA01 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

Velika<br />

Britanija<br />

Slovenija<br />

steklenička po 150 ml (53,3 mg/ ml) B03AB09 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

N02BE51 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N02BE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LEKADOL TABLETE paracetamol 20 × 500 mg N02BE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

4. 1. 2004 LEKOKLAR tablete 250 mg klaritromicin škatla s 14 tabletami po 250 mg (2 × 7<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 LEKOKLAR tablete 500 mg klaritromicin škatla s 14 tabletami po 500 mg (2 × 7<br />

tablet v pretisnem omotu)<br />

J01FA09 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01FA09 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

1. 7. 2004 LEKONIL kapljice za nos 0,05% oksimetazolin zlozˇenka s plastenko po 10 ml raztopine R01AA05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

1. 7. 2004 LEKONIL P kapljice za<br />

nos 0,025%<br />

oksimetazolin zlozˇenka s plastenko po 10 ml raztopine R01AA05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

8. 11. 2001 LEKOPTIN drazˇeji 120 mg verapamil 20 × 120 mg C08DA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

8. 11. 2001 LEKOPTIN drazˇeji 80 mg verapamil 50 × 80 mg C08DA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

8. 11. 2001 LEKOPTIN injekcije 5mg/2ml verapamil 50 ampul po 2 ml (5 mg/2 ml) C08DA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

1552 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

8. 11. 2001 LEKOPTIN MITE drazˇeji 40 mg verapamil 30 × 40 mg C08DA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

8. 11. 2001 LEKOPTIN MITE drazˇeji 40 mg verapamil 50 × 40 mg C08DA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

8. 11. 2001 LEKOPTIN MITE drazˇeji 40 mg verapamil 500 × 40 mg C08DA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

8. 11. 2001 LEKOPTIN RETARD tablete<br />

240 mg<br />

verapamil 20 × 240 mg C08DA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

10. 11. 2002 LEKOTAM TABLETE 1,5 mg bromazepam 30 × 1,5 mg N05BA08 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

10. 11. 2002 LEKOTAM TABLETE 3 mg bromazepam 30 × 3 mg N05BA08 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

10. 11. 2002 LEKOTAM TABLETE 6 mg bromazepam 20 × 6 mg N05BA08 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

10. 11. 2002 LEKOTAM TABLETE 6 mg bromazepam 100 × 6 mg N05BA08 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 1 g ceftriakson 10 stekleničk po 1 g J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 250 mg ceftriakson 50 stekleničk po 250 mg J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 1 g ceftriakson 1steklenička po 1g in 1 steklenička po<br />

3,5 ml lidokainijevega klorida (1%)<br />

J01DA63 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 1 g ceftriakson 5 stekleničk po 1g J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 1 g ceftriakson 1 steklenička po 1g J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 1 g ceftriakson 50 stekleničk po 1 g J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 1 g ceftriakson 5 stekleničk po 1g in 5 ampul po 10 ml<br />

vode za injekcije<br />

7. 3. 2002 LENDACIN injekcije 1 g ceftriakson 1 steklenička po 1g in 1 ampula po<br />

10 ml vode za injekcije<br />

7. 3. 2002 LENDACIN injekcije 1g ceftriakson 5 stekleničk po 1g in 5 stekleničk po<br />

3,5 ml lidokainijevega klorida (1%)<br />

J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01DA63 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 2 g ceftriakson 50 stekleničk po 2 g J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 2 g ceftriakson 10 stekleničk po 2 g J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1553


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

7. 3. 2002 LENDACIN injekcije 2 g ceftriakson 5 stekleničk po 2 g J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 2 g ceftriakson 1 steklenička po 2 g J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 250 mg ceftriakson 5 stekleničk po 250 mg J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 250 mg ceftriakson 1 steklenička po 250mg J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 LENDACIN injekcije 250 mg ceftriakson 10 stekleničk po 250 mg J01DA13 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

8. 5. 2003 LEPONEX 25 mg klozapin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

8. 5. 2003 LEPONEX 100 mg klozapin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

N05AH02 Novartis Pharmaceuticals UK<br />

Ltd., Horsham, Velika<br />

N05AH02 Novartis Pharmaceuticals UK<br />

Ltd., Horsham, Velika<br />

29. 11. 2004 LERGIN krema hidrokortizon zlozˇenka s tubo po 15 g kreme (10 mg/g) D07AA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

29. 11. 2004 LETIZEN filmsko oblozˇene<br />

tablete 10 mg<br />

29. 11. 2004 LETIZEN filmsko oblozˇene<br />

tablete 10 mg<br />

cetirizin zlozˇenka z 10 tabletami ( 1 × 10 tablet v<br />

pretisnem omotu)<br />

cetirizin zlozˇenka z 20 tabletami ( 2 × 10 tablet v<br />

pretisnem omotu)<br />

R06AE07 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

R06AE07 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 LEUKERAN tablete 2 mg klorambucil 25 × 2 mg L01AA02 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

9. 7. 2003 LEUKERAN tablete 5 mg klorambucil 25 × 5 mg L01AA02 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

12. 1. 2003 LEVOVIST galaktoza viala po 4 g praška, plastična ampula po<br />

20 ml vode za injekcije, 20 mililitrska<br />

injekcijska brizga in odvzemnik<br />

12. 1. 2003 LEVOVIST galaktoza viala po 2,5 g praška, plastična ampula<br />

po 20 ml vode za injekcije, 20 mililitrska<br />

injekcijska brizga in odvzemnik<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Britanija za Novartis<br />

Pharma AG, Basel,<br />

Švica<br />

Britanija za Novartis<br />

Pharma AG, Basel,<br />

Švica<br />

d.d., Ljubljana Slovenija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Slovenija<br />

Slovenija<br />

V08DA02 Schering AG, Berlin, Nemčija<br />

V08DA02 Schering AG, Berlin, Nemčija<br />

12. 4. 2001 LEXAURIN 1,5 mg bromazepam 30 × 1,5 mg N05BA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 4. 2001 LEXAURIN 3 mg bromazepam 30 × 3 mg N05BA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 4. 2001 LEXAURIN 6 mg bromazepam 30 × 6mg N05BA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

1554 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

7. 3. 2002 LIDOKAIN injekcije 1% lidokain 10 ampul po 3,5 ml (35mg/3,5ml) N01BB02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

12. 1. 2003 LIPOBAY 0,2 cerivastatin 30 × 0,2 mg C10AA06 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

2. 6. 2005 LIPOBAY 0,4 cerivastatin zlozˇenka s 30 tabletami C10AA06 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

28. 6. 2001 LIPSANA 200 mg kapsule fenofibrat 30 × 200 mg C10AB05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

28. 6. 2001 LITHII CARBONATIS<br />

TABLETTAE<br />

litij 100 × 300 mg N05AN01 Lekarna Ljubljana, PE<br />

Galenski laboratorij,<br />

d.d., Ljubljana Slovenija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

d.d., Ljubljana Slovenija<br />

Ljubljana Slovenija<br />

9. 7. 2003 LIVIAL tibolon 28 × 2,5 mg G03DC05 N. V. Organon, Oss, Nizozemska<br />

28. 6. 2001 LIVOSTIN kapljice za oko 0,5% levokabastin plastenka po 4 ml (0,5mg/1ml) S01GX02 Janssen-Cilag, Beerse Belgija<br />

28. 6. 2001 LIVOSTIN pršilo za nos 0,5% levokabastin plastenka po 10 ml (0,5mg/1ml) R01AC02 Janssen-Cilag, Beerse Belgija<br />

11. 2. 2003 LOCACORTEN N krema flumetazon tuba po 15 g D07CB05 Pliva d.d., Zagreb Hrvaška<br />

11. 2. 2003 LOCACORTEN N mazilo flumetazon tuba po 15 g D07CB05 Pliva d.d., Zagreb Hrvaška<br />

9. 7. 2003 LOCASALEN flumetazon tuba po 30 g D07XB01 Pliva d.d., Zagreb Hrvaška<br />

30. 5. 2002 LOCERYL amorolfin zlozˇenka s stekleničko po 2,5 ml laka<br />

(5%), 16 tamponi prepojenimi s<br />

70-odstotnim izopropilnim alkoholom,<br />

10 lopaticami in 15 pilicami za nohte<br />

12. 9. 2005 LOCOIDON CRELO hidrokortizonbutirat<br />

12. 9. 2005 LOCOIDON LIPOCREMA hidrokortizonbutirat<br />

zlozˇenka s kapalno plastenko po 30 ml<br />

emulzije<br />

2. 6. 2005 LOGEST gestoden zlozˇenka z 21 tabletami (1 × 21 tablet v<br />

pretisnem omotu) (1 tableta vsebuje<br />

0,075 mg gestodena in 0,02 mg<br />

etinilestradiola)<br />

D01AE16 Produits Roche<br />

S.A.,Fontenay-sous-<br />

Bois,Francija za<br />

D07AB02 Yamanouchi Pharma S.p.A.,<br />

Carugate (MI)<br />

zlozˇenka s tubo po 30 g kreme D07AB02 Yamanouchi Pharma S.p.A.,<br />

Carugate (MI)<br />

G03AA10 Schering SA, Lys Lez<br />

Lannoy, Francija za Schering<br />

2. 4. 2003 LOKOHEPAN heparin tuba po 40 g C05BA53 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

2. 4. 2003 LOKOHEPAN heparin tuba po 40 g C05BA53 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

7. 12. 2003 LONITEN 10 mg minoksidil zlozˇenka s stekleničko po 100 tablet C02DC01 Global Pharm Inc., Toronto,<br />

Ontario,<br />

7. 12. 2003 LONITEN 5 mg minoksidil zlozˇenka s stekleničko po 100 tablet C02DC01 Global Pharm Inc., Toronto,<br />

Ontario,<br />

1. 10. 2004 LONTERMIN sirup 25 µg/5 ml prokaterol zlozˇenka s stekleničko po 120 ml sirupa R03CC08 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Laboratoires Galderma<br />

S.A.,Levallois-Perret<br />

Cedex<br />

AG, Berlin, Nemčija<br />

Kanada za Pharmacio<br />

& Upjohn S.A.<br />

Kanada za Pharmacio<br />

& Upjohn S.A.<br />

Francija<br />

Italija<br />

Italija<br />

Slovenija<br />

Slovenija<br />

Luksemburg<br />

Luksemburg<br />

d.d., Ljubljana Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1555


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

1. 10. 2004 LONTERMIN tablete 50 µg prokaterol zlozˇenka s stekleničko po 20 tablet R03CC08 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 LORAM tablete 1 mg lorazepam 30 × 1 mg N05BA06 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 LORAM tablete 2,5 mg lorazepam 20 × 2,5 mg N05BA06 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 10. 2005 LORISTA filmsko oblozˇene<br />

tablete 50 mg<br />

losartan zlozˇenka z 28 tabletami v pretisnem<br />

omotu<br />

C09CA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

8. 11. 2001 LOTRIDERM krema klotrimazol tuba po 15 g kreme D01AC20 Schering — Plough Labo N.<br />

V., Heist-op-den-Berg,<br />

2. 4. 2003 MACROPEN midekamicin 16 × 400 mg J01FA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

30. 5. 2002 MADOPAR 125 levodopa 100 tablet N04BA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

28. 6. 2001 MADOPAR 125 levodopa 100 kapsul N04BA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

30. 5. 2002 MADOPAR 250 levodopa 100 tablet N04BA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

28. 6. 2001 MADOPAR 250 levodopa 100 kapsul N04BA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

28. 6. 2001 MADOPAR HBS levodopa 30 kapsul N04BA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

28. 6. 2001 MADOPAR HBS levodopa 100 kapsul N04BA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

28. 6. 2001 MADOPAR LIQ 125 levodopa zlozˇenka s stekleničko po 30 tablet za<br />

peroralno suspenzijo<br />

N04BA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

7. 5. 2004 MAKROCEF cefotaksim zlozˇenka z 1 vialo po 2 g cefotaksima J01DA10 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

7. 5. 2004 MAKROCEF cefotaksim zlozˇenka z 1 vialo po 1 g cefotaksima J01DA10 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

9. 4. 2004 MANIT 10 % manitol steklenica po 500 ml raztopine B05BC01 Pliva d.d., Zagreb Hrvaška<br />

9. 4. 2004 MANIT 20 % manitol škatla z 10 prebodnimi steklenicami po<br />

250 ml raztopine<br />

Slovenija<br />

Belgija<br />

Slovenija<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Slovenija<br />

Slovenija<br />

B05BC01 Pliva d.d., Zagreb Hrvaška<br />

9. 7. 2003 MARVELON desorgestrel 21 tablet G03AA09 N. V. Organon, Oss, Nizozemska<br />

29. 11. 2004 MAXALT 10 mg rizatriptan zlozˇenka z 2 tabletama (1 × 2 tableti v<br />

pretisnem omotu)<br />

N02CC04 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

1556 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

29. 11. 2004 MAXALT 10 mg rizatriptan zlozˇenka s 6 tabletami (2 × 3 tablete v<br />

pretisnem omotu)<br />

29. 11. 2004 MAXALT 5 mg rizatriptan zlozˇenka s 6 tabletami (2 × 3 tablete v<br />

pretisnem omotu)<br />

29. 11. 2004 MAXALT 5 mg rizatriptan zlozˇenka z 2 tabletama (1 × 2 tableti v<br />

pretisnem omotu)<br />

29. 11. 2004 MAXALT RPD 10 mg rizatriptan zlozˇenka s plastično škatlico po 2 tableti<br />

v pretisnem omotu in v zaščitni foliji<br />

29. 11. 2004 MAXALT RPD 10 mg rizatriptan zlozˇenka s 6 tabletami (dve plastični<br />

škatlici po 3 tablete v pretisnem omotu in<br />

v zaščitni foliji)<br />

29. 11. 2004 MAXALT RPD 5 mg rizatriptan zlozˇenka s plastično škatlico po 2 tableti<br />

v pretisnem omotu in v zaščitni foliji<br />

29. 11. 2004 MAXALT RPD 5 mg rizatriptan zlozˇenka s 6 tabletami (dve plastični<br />

škatlici po 3 tablete v pretisnem omotu in<br />

v zaščitni foliji)<br />

1. 10. 2004 MAXIDEX kapljice za oko deksametazon zlozˇenka s kapalno plastenko po 5 ml<br />

suspenzije<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

N02CC04 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

N02CC04 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

N02CC04 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

N02CC04 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

N02CC04 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

N02CC04 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

N02CC04 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

S01BA01 S.A. Alcon-Couvreur N.V.,<br />

Puurs, Belgija za Alcon<br />

1. 10. 2004 MAXIDEX mazilo za oko deksametazon zlozˇenka s tubo po 3,5 g mazila za oko S01BA01 S.A. Alcon-Couvreur N.V.,<br />

Puurs, Belgija za Alcon<br />

3. 11. 2003 MEDROL metilprednizolon 30 × 4 mg H02AB04 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

7. 3. 2002 MEDROL 100 mg metilprednizolon zlozˇenka z 20 tabletami H02AB04 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

7. 3. 2002 MEDROL 16 mg metilprednizolon zlozˇenka s 50 tabletami H02AB04 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

7. 3. 2002 MEDROL 32 mg metilprednizolon zlozˇenka z 20 tabletami H02AB04 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

24. 6. 2004 MEGACE peroralna suspenzija megestrol zlozˇenka s plastičnim vsebnikom (z za<br />

otroke varno zaporko) po 240 ml<br />

suspenzije<br />

L02AB01 Bristol-Myers Squibb,<br />

Evansville, Indiana, ZDA za<br />

28. 6. 2001 MEGAMOX 1000 mg tablete amoksicilin 100 × 1000 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

Pharmaceuticals Ltd.,<br />

Hünenberg, Švica<br />

Pharmaceuticals Ltd.,<br />

Hünenberg, Švica<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Bristol-Myers Squibb<br />

Co., Princeton, New<br />

Yersey<br />

ZDA<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1557


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

28. 6. 2001 MEGAMOX 1000 mg tablete amoksicilin 20 × 1000 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 MEGAMOX 1000 mg tablete amoksicilin 10 × 1000 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 MEGAMOX 500 mg tablete amoksicilin 100 × 500 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 MEGAMOX 500 mg tablete amoksicilin 20 × 500 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 MEGAMOX 500 mg tablete amoksicilin 10 × 500 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 MEGAMOX 750 mg tablete amoksicilin 100 × 750 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 MEGAMOX 750 mg tablete amoksicilin 20 × 750 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 MEGAMOX 750 mg tablete amoksicilin 10 × 750 mg J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 MEGAMOX prašek za peroralno<br />

suspenzijo<br />

amoksicilin steklenička s praškom za pripravo 60 ml<br />

suspenzije (375mg/5ml)<br />

J01CA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 4. 2001 MELLERIL tablete 10 mg tioridazin zlozˇenka s stekleničko po 30 tablet N05AC02 Novartis Pharmaceuticals UK<br />

Ltd., Horsham, Velika<br />

12. 4. 2001 MELLERIL tablete 100 mg tioridazin zlozˇenka s stekleničko po 30 tablet N05AC02 Novartis Pharmaceuticals UK<br />

Ltd., Horsham, Velika<br />

12. 4. 2001 MELLERIL tablete 25 mg tioridazin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

27. 9. 2005 MENCEVAX AC dvovalentno<br />

cepivo proti<br />

meningokokom s<br />

prečiščenimi<br />

polisaharidnimi<br />

antigeni<br />

27. 9. 2005 MENCEVAX ACWY štirivalentno<br />

cepivo proti<br />

meningokokom s<br />

prečiščenimi<br />

polisaharidnimi<br />

antigeni<br />

zlozˇenka z eno vialo s praškom in 1 vialo<br />

po 0,5 ml raztopine natrijevega klorida<br />

zlozˇenka z 1 vialo s praškom in 1<br />

ampulo po 0,5 ml raztopine natrijevega<br />

klorida<br />

6. 3. 2003 MERONEM meropenem prebodna steklenička po 500 mg in<br />

ampula po 2 ml topila<br />

N05AC02 Novartis Pharmaceuticals UK<br />

Ltd., Horsham, Velika<br />

J07AH03 SmithKline Beecham<br />

Biologicals s.a., Rixensart,<br />

J07AH04 SmithKline Beecham<br />

Biologicals s.a., Rixensart,<br />

J01DH02 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

Britanija za Novartis<br />

Pharma AG, Basel,<br />

Švica<br />

Britanija za Novartis<br />

Pharma AG, Basel,<br />

Švica<br />

Britanija za Novartis<br />

Pharma AG, Basel,<br />

Švica<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Belgija<br />

Belgija<br />

Velika<br />

Britanija<br />

1558 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

6. 3. 2003 MERONEM meropenem 10 prebodnih stekleničk po 500 mg J01DH02 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

6. 3. 2003 MERONEM meropenem 10 prebodnih stekleničk po 1 g J01DH02 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

23. 6. 2003 MESTINON piridostigmin 20 × 60 mg N07AA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

2. 4. 2003 METABLEN kapljice za oko<br />

0,25 %<br />

timolol kapalna plastenka po 5 ml (2,5 mg/ml) S01ED01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 METABLEN kapljice za oko 0,5% timolol kapalna plastenka po 5 ml (5 mg/ml) S01ED01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

30. 5. 2002 METRONIDAZOL 500 mg metronidazol steklenička po 100 ml raztopine J01XD01 B. Braun Melsungen AG,<br />

Melsungen<br />

24. 6. 2004 MEXITIL 200 mg meksiletin zlozˇenka s 50 kapsulami (5 × 10 kapsul v<br />

pretisnem omotu)<br />

24. 6. 2004 MEXITIL 50 mg meksiletin zlozˇenka s 100 kapsulami (10 × 10<br />

kapsul v pretisnem omotu)<br />

8. 11. 2001 MEXITIL DEPO meksiletin zlozˇenka z 20 kapsulami (2 × 10 kapsul<br />

v pretisnem omotu)<br />

4. 1. 2004 MIACALCIC pršilo za nos,<br />

200 I.E.<br />

sintezni<br />

kalcitonin lososa<br />

zlozˇenka s stekleničko (z nosnikom) po<br />

2 ml raztopine<br />

12. 7. 2004 MICROGYNON levonorgestrel zlozˇenka s 63 tabletami (3 × 21 tablet v<br />

pretisnem omotu)<br />

19. 3. 2004 MILTEX dermalna raztopina<br />

60 mg/ml<br />

miltefozin zlozˇenka s plastičnim vsebnikom, v<br />

katerem je stekleni vsebnik z 10 ml<br />

raztopine in kapalni nastavek, v pakiranju<br />

tudi zlozˇenka z 20 rokavicami<br />

24. 6. 2004 MINULET gestoden zlozˇenka z 21 tabletami (1 × 21 tablet v<br />

pretisnem omotu)<br />

19. 3. 2004 MIOSTAT karbahol zlozˇenka z 12 vialami po 1,5 ml<br />

raztopine (0,1 mg/ml)<br />

7. 5. 2004 MIRENA (plastični<br />

intrauterini<br />

vlozˇek z<br />

dodatkom<br />

levonorgestrela)<br />

zlozˇenka z enim intrauterinim vlozˇkom<br />

(52 mg levonorgestrela)<br />

9. 4. 2004 MIROCEF injekcije 1g ceftazidim zlozˇenka s 5 prebodnimi stekleničkami s<br />

praškom<br />

9. 4. 2004 MIROCEF injekcije 500 mg ceftazidim zlozˇenka s 5 prebodnimi stekleničkami s<br />

praškom<br />

C01BB02 Boehringer Ingelheim<br />

Pharma KG, Nemčija za<br />

C01BB02 Boehringer Ingelheim<br />

Pharma KG, Nemčija za<br />

C01BB02 Boehringer Ingelheim<br />

International GmbH,<br />

H05BA01 Novartis Pharma<br />

S.A.,Huningue,Francija ali<br />

Mipharm<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Švica<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Boehringer Ingelheim<br />

International GmbH<br />

Boehringer Ingelheim<br />

International GmbH<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Ingelheim am Rhein Nemčija<br />

S.p.A., Milano, Italija za<br />

Novartis Pharma AG<br />

Švica<br />

G03AA07 Schering AG, Berlin, Nemčija<br />

L01XX09 Asta Medica AG, Frankfurt<br />

am Main, Nemčija, za<br />

G03AA10 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

S01EB02 Alcon Laboratories, Inc.<br />

ZDA, za Alcon<br />

G02BA03 Leiras Oy, Turku, Finska, za<br />

Schering AG, Berlin,<br />

Asta Medica AG,<br />

Dresden<br />

sodelovanju z Wyeth-<br />

Lederle Pharma GmbH,<br />

Dunaj<br />

Pharmaceuticals Ltd.,<br />

Cham, Švica<br />

Nemčija<br />

Nemčija<br />

Avstrija<br />

J01DA11 Pliva d.d., Zagreb Hrvaška<br />

J01DA11 Pliva d.d., Zagreb Hrvaška<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1559


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

9. 7. 2003 MITEKOL 3 vagitoriji 150 mg ekonazol 3 × 150 mg G01AF05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 MITEKOL emulzija 1 % ekonazol plastenka po 30 ml (10 mg/ml) D01AC03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 MITEKOL krema 1 % ekonazol tuba po 15 g (10 mg/g) D01AC03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 MITEKOL prašek 1 % ekonazol lonček po 30 g (10 mg/g) D01AC03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 MITEKOL raztopina 1 % ekonazol plastenka po 30 ml (10 mg/ml) D01AC03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 MIVACRON mivakurijev<br />

klorid<br />

9. 7. 2003 MIXTARD 10 NovoLet<br />

100 IU/ml, 3 ml<br />

insulin, človeški,<br />

biosintetični<br />

30. 5. 2002 MIXTARD 10 PENFILL 3 ml insulin, človeški,<br />

biosintetični<br />

9. 7. 2003 MIXTARD 20 HM Penfill<br />

100 IU/ml, 1,5 ml<br />

9. 7. 2003 MIXTARD 20 NovoLet<br />

100 IU/ml, 3 ml<br />

insulin, človeški,<br />

biosintetični<br />

insulin, človeški,<br />

biosintetični<br />

30. 5. 2002 MIXTARD 20 PENFILL 3 ml insulin, človeški,<br />

biosintetični<br />

9. 7. 2003 MIXTARD 30 HM Penfill<br />

100 IU/ml, 1,5 ml<br />

insulin, človeški,<br />

biosintetični<br />

7. 3. 2002 MIXTARD 30 NOVOLET insulin, človeški,<br />

biosintetični<br />

9. 7. 2003 MIXTARD 30 NovoLet<br />

100 IU/ml, 3 ml<br />

insulin, človeški,<br />

biosintetični<br />

30. 5. 2002 MIXTARD 30 PENFILL 3 ml insulin, človeški,<br />

biosintetični<br />

9. 7. 2003 MIXTARD 40 NovoLet<br />

100 IU/ml, 3 ml<br />

insulin, človeški,<br />

biosintetični<br />

30. 5. 2002 MIXTARD 40 PENFILL 3 ml insulin, človeški,<br />

biosintetični<br />

9. 7. 2003 MIXTARD 50 NovoLet<br />

100 IU/ml, 3 ml<br />

insulin, človeški,<br />

biosintetični<br />

5 ampul po 10 ml (20 mg/10 ml) M03AC10 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

5 napolnjenih injekcijskih brizg v obliki<br />

peresa po 3 ml (300 I.E./3 ml)<br />

zlozˇenka s 5 karpulami po 3 ml<br />

suspenzije (100I.E./ml)<br />

5 vlozˇkov po 1,5 ml (150 I.E./1,5 ml) za<br />

uporabo v injekcijskem peresu NovoPen<br />

5 napolnjenih injekcijskih brizg v obliki<br />

peresa po 3 ml (300 I.E./3 ml)<br />

zlozˇenka s 5 karpulami po 3 ml<br />

suspenzije (100I.E./ml)<br />

5 vlozˇkov po 1,5 ml (150 I.E./1,5 ml) za<br />

uporabo v injekcijskem peresu NovoPen<br />

5 napolnjenih injekcijskih brizg v obliki<br />

peresa NovoLet po 1,5 ml suspenzije<br />

5 napolnjenih injekcijskih brizg v obliki<br />

peresa po 3 ml (300 I.E./3 ml)<br />

zlozˇenka s 5 karpulami po 3 ml<br />

suspenzije<br />

5 napolnjenih injekcijskih brizg v obliki<br />

peresa po 3 ml (300 I.E./3 ml)<br />

zlozˇenka s 5 karpulami po 3 ml<br />

suspenzije<br />

5 napolnjenih injekcijskih brizg v obliki<br />

peresa po 3 ml (300 I.E./3 ml)<br />

A10AD01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10AD01 Pliva d.d. Zagreb v<br />

sodelovanju z Novo Nordisk<br />

A/S<br />

A10AD01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10AD01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10AD01 Pliva d.d. Zagreb v<br />

sodelovanju z Novo Nordisk<br />

A/S<br />

A10AD01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10AD01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10AD01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10AD01 Pliva d.d. Zagreb v<br />

sodelovanju z Novo Nordisk<br />

A/S<br />

A10AD01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10AD01 Pliva d.d. Zagreb v<br />

sodelovanju z Novo Nordisk<br />

A/S<br />

A10AD01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

1560 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

30. 5. 2002 MIXTARD 50 PENFILL 3 ml insulin, človeški,<br />

biosintetični<br />

zlozˇenka s 5 karpulami po 3 ml<br />

suspenzije<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

A10AD01 Pliva d.d. Zagreb v<br />

sodelovanju z Novo Nordisk<br />

A/S<br />

11. 2. 2003 MODITEN flufenazin 100 × 5 mg N05AB02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

11. 2. 2003 MODITEN flufenazin 100 × 2,5 mg N05AB02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

11. 2. 2003 MODITEN flufenazin 25 × 1 mg N05AB02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

11. 2. 2003 MODITEN flufenazin 5 ampul po 1 ml (2,5 mg/ml) N05AB02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

11. 2. 2003 MODITEN DEPO flufenazin 5 ampul po 1 ml (25 mg/ml) N05AB02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

4. 1. 2004 MODOLEX PLUS rektalno mazilo kalcijev dobesilat škatla s tubo po 20 g mazila in<br />

aplikatorjem (1 g mazila vsebuje: 0,25 mg<br />

deksametazonacetata, 20 mg<br />

lidokainijevega klorida, 40 mg kalcijevega<br />

dobesilata)<br />

4. 1. 2004 MODOLEX PLUS svečke kalcijev dobesilat škatla z 8 svečkami v dvojnem traku<br />

(1 svečka vsebuje: 0,25 mg<br />

deksametazonacetata, 40 mg<br />

lidokainijevega klorida, 250 mg<br />

kalcijevega dobesilata)<br />

4. 1. 2004 MODOLEX rektalno mazilo lidokain škatla s tubo po 30 g rektalnega mazila in<br />

aplikatorjem<br />

4. 1. 2004 MODOLEX svečke kalcijev dobesilat škatla z 10 svečkami v dvojnem traku<br />

(1svečka vsebuje: 40 mg lidokainijevega<br />

klorida, 250 mg kalcijevega dobesilata)<br />

C05AA09 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

C05AA09 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

C05AD01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

C05AD01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 MODURETIC tablete hidroklorotiazid 40 tablet C03EA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

28. 6. 2001 MONO-5-WOLFF 20 izosorbidmononitrat<br />

28. 6. 2001 MONO-5-WOLFF 40 izosorbidmononitrat<br />

28. 6. 2001 MONO-5-WOLFF 40 izosorbidmononitrat<br />

28. 6. 2001 MONO-5-WOLFF 20 izosorbidmononitrat<br />

50 × 20 mg C01DA14 Dr. August Wolff & Co.,<br />

Arzneimittel, Bielefeld<br />

50 × 40 mg C01DA14 Dr. August Wolff & Co.,<br />

Arzneimittel, Bielefeld<br />

100 × 40 mg C01DA14 Dr. August Wolff & Co.,<br />

Arzneimittel, Bielefeld<br />

100 × 20 mg C01DA14 Dr. August Wolff & Co.,<br />

Arzneimittel, Bielefeld<br />

Danska<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1561


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

19. 3. 2004 MONOPRIL fozinopril zlozˇenka z 28 tabletami po 20 mg (2 ×<br />

14 tablet v pretisnem omotu)<br />

19. 3. 2004 MONOPRIL fozinopril zlozˇenka z 28 tabletami po 10 mg (2 ×<br />

14 tablet v pretisnem omotu)<br />

30. 5. 2002 MONOSAN 20 mg izosorbidmononitrat<br />

30. 5. 2002 MONOSAN 40 mg izosorbidmononitrat<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

C09AA09 Bristol-Myers Squibb S.p.A.,<br />

Anagni<br />

C09AA09 Bristol-Myers Squibb S.p.A.,<br />

Anagni<br />

30. 5. 2002 MOVALIS meloksikam 20 × 15 mg M01AC06 Boehringer Ingelheim<br />

International GmbH,<br />

30. 5. 2002 MOVALIS meloksikam 6 svečk po 15 mg M01AC06 Boehringer Ingelheim<br />

International GmbH,<br />

30. 5. 2002 MOVALIS meloksikam 20 × 7,5 mg M01AC06 Boehringer Ingelheim<br />

International GmbH,<br />

5. 6. 2005 MST CONTINUS suspenzija<br />

100 mg<br />

5. 6. 2005 MST CONTINUS suspenzija<br />

20 mg<br />

5. 6. 2005 MST CONTINUS suspenzija<br />

200 mg<br />

5. 6. 2005 MST CONTINUS suspenzija<br />

30 mg<br />

5. 6. 2005 MST CONTINUS suspenzija<br />

60 mg<br />

(Frosinone) Italija<br />

(Frosinone) Italija<br />

C01DA14 PRO.MED.CS., Praga Češka,<br />

Republika<br />

C01DA14 PRO.MED.CS., Praga Češka,<br />

Republika<br />

morfin zlozˇenka s 30 vrečkami N02AA01 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

morfin zlozˇenka s 30 vrečkami N02AA01 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

morfin zlozˇenka s 30 vrečkami N02AA01 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

morfin zlozˇenka s 30 vrečkami N02AA01 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

morfin zlozˇenka s 30 vrečkami N02AA01 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

28. 6. 2001 MST CONTINUS tablete 10 mg morfin zlozˇenka s 60 tabletami v pretisnem<br />

omotu<br />

28. 6. 2001 MST CONTINUS tablete 100 mg morfin zlozˇenka s 60 tabletami v pretisnem<br />

omotu<br />

28. 6. 2001 MST CONTINUS tablete 30 mg morfin zlozˇenka s 60 tabletami v pretisnem<br />

omotu<br />

28. 6. 2001 MST CONTINUS tablete 60 mg morfin zlozˇenka s 60 tabletami v pretisnem<br />

omotu<br />

N02AA01 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

N02AA01 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

N02AA01 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

N02AA01 Bard Pharmaceuticals Ltd. za<br />

Mundipharma Medical<br />

12. 1. 2003 MUKOLEN eprazinon 20 × 50 mg R05CB04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

22. 2. 2004 MUTAMYCIN 20 mg mitomicin zlozˇenka z 1 vialo s praškom L01DC03 Bristol Caribbean Inc., Puerto<br />

Rico, ZDA za<br />

22. 2. 2004 MUTAMYCIN 40 mg mitomicin zlozˇenka z 1 vialo s praškom L01DC03 Bristol Caribbean Inc., Puerto<br />

Rico, ZDA za<br />

Ingelheim am Rhein Nemčija<br />

Ingelheim am Rhein Nemčija<br />

Ingelheim am Rhein Nemčija<br />

Company, Hamilton,<br />

Bermuda<br />

Company, Hamilton,<br />

Bermuda<br />

Company, Hamilton,<br />

Bermuda<br />

Company, Hamilton,<br />

Bermuda<br />

Company, Hamilton,<br />

Bermuda<br />

Company, Hamilton,<br />

Bermuda<br />

Company, Hamilton,<br />

Bermuda<br />

Company, Hamilton,<br />

Bermuda<br />

Company, Hamilton,<br />

Bermuda<br />

sodelovanju s CERM,<br />

Francija<br />

Bristol-Myers Squibb<br />

Co., Princeton, New<br />

Jersey<br />

Bristol-Myers Squibb<br />

Co., Princeton, New<br />

Jersey<br />

ZDA<br />

ZDA<br />

1562 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

22. 2. 2004 MUTAMYCIN 5 mg mitomicin zlozˇenka z 1 vialo s praškom L01DC03 Bristol Caribbean Inc., Puerto<br />

Rico, ZDA za<br />

3. 11. 2003 MYCOSPOR bifonazol tuba po 15 g (10 mg/g) D01AC10 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

3. 11. 2003 MYCOSPOR bifonazol vrtljiva tuba po 10 g mazila (10 mg/g),<br />

15 oblizˇev in strgalo<br />

3. 11. 2003 MYCOSPOR bifonazol steklenička po 25 ml (10 mg/ml) z<br />

zaporko s pršilnim ventilom<br />

7. 12. 2003 MYCOSPOR bifonazol škatla s plastenko po 100 g zdravilnega<br />

šampona (10 mg/g)<br />

D01AC10 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

D01AC10 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

D01AC10 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

10. 11. 2002 MYLERAN busulfan 100 × 2 mg L01AB01 The Wellcome Foundation<br />

Ltd. London<br />

20. 12. 2001 NACLOF diklofenak kapalna plastenka po 5 ml raztopine<br />

(1 mg/1ml)<br />

S01BC03 Ciba Vision Dispersa Ltd.,<br />

Hettlingen<br />

10. 11. 2002 NAKLOFEN diklofenak tuba po 60 g M02AA15 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

19. 3. 2004 NAKLOFEN diklofenak zlozˇenka s 5 ampulami po 3 ml raztopine<br />

(75 mg/3 ml)<br />

19. 3. 2004 NAKLOFEN diklofenak zlozˇenka z 20 tabletami po 50 mg (2 ×<br />

10 tablet v pretisnem omotu)<br />

19. 3. 2004 NAKLOFEN diklofenak zlozˇenka z 10 svečkami v dvojnem traku<br />

(10 × 50 mg)<br />

24. 6. 2004 NAKLOFEN DUO diklofenak zlozˇenka z 20 kapsulami po 75 mg (2 ×<br />

10 kapsul v pretisnem omotu)<br />

M01AB05 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

M01AB05 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

M01AB05 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

M01AB05 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

9. 7. 2003 NAKLOFEN RAPID diklofenak 10 × 50 mg M01AB05 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

16. 12. 2002 NAKLOFEN RETARD diklofenak 28 × 100 mg M01AB05 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

16. 12. 2002 NAKLOFEN RETARD diklofenak 20 × 100 mg M01AB05 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

19. 3. 2004 NAKLOFEN retard diklofenak zlozˇenka z 20 tabletami po 100 mg (2 ×<br />

10 tablet v pretisnem omotu)<br />

12. 1. 2003 NAKOM MITE tablete<br />

100 mg/25 mg<br />

M01AB05 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

levodopa 100 tablet N04BA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 NAKOM R karbidopa 100 tablet (1 tableta vsebuje 200 mg<br />

levodope, 50 mg karbidope)<br />

N04BA02 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

Bristol-Myers Squibb<br />

Co., Princeton, New<br />

Jersey<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

ZDA<br />

(Glaxo Wellcome) Velika<br />

Britanija<br />

sodelovanju s Klinge<br />

Pharma GmbH,<br />

München<br />

Švica<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Nemčija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1563


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

12. 1. 2003 NAKOM tablete 250 mg/25 mg levodopa 100 tablet N04BA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

1. 7. 2004 NALGESIN filmsko oblozˇene<br />

tablete 275 mg<br />

1. 7. 2004 NALGESIN forte filmsko<br />

oblozˇene tablete 550 mg<br />

naproksen zlozˇenka z 10 tabletami v pretisnem<br />

omotu<br />

naproksen zlozˇenka z 10 tabletami v pretisnem<br />

omotu<br />

M01AE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

M01AE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 NAPROSYN naproksen 20 × 500 mg M01AE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

9. 7. 2003 NAPROSYN naproksen steklenička po 100 ml (125 mg/5 ml) M01AE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

9. 7. 2003 NAPROSYN naproksen 10 × 500 mg M01AE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

9. 7. 2003 NAPROSYN naproksen 50 × 375 mg M01AE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

18. 1. 2001 NAPROSYN injekcije naproksen 5 ampul po 5 ml raztopine<br />

(550 mg/5 ml)<br />

M01AE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 NARAMIG naratriptan 4 × 2,5 mg N02CC02 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

19. 3. 2004 NARCANTI nalokson zlozˇenka z 10 ampulami po 1 ml<br />

raztopine (0,4 mg/ml)<br />

7. 12. 2003 NAROPIN ropivakain škatla s 5 plastičnimi ampulami po 10 ml<br />

(2 mg/ml) v pretisnem omotu<br />

7. 12. 2003 NAROPIN ropivakain škatla s 5 plastičnimi ampulami po 10 ml<br />

(7,5 mg/ml) v pretisnem omotu<br />

7. 12. 2003 NAROPIN ropivakain škatla s 5 plastičnimi ampulami po 20 ml<br />

(2 mg/ml) v pretisnem omotu<br />

7. 12. 2003 NAROPIN ropivakain škatla s 5 plastičnimi vrečkami po 200 ml<br />

(2 mg/ml)<br />

7. 12. 2003 NAROPIN ropivakain škatla s 5 plastičnimi ampulami po 20 ml<br />

(10 mg/ml) v pretisnem omotu<br />

7. 12. 2003 NAROPIN ropivakain škatla s 5 plastičnimi ampulami po 20 ml<br />

(7,5 mg/ml) v pretisnem omotu<br />

7. 12. 2003 NAROPIN ropivakain škatla s 5 plastičnimi ampulami po 10 ml<br />

(10 mg/ml) v pretisnem omotu<br />

7. 12. 2003 NAROPIN ropivakain škatla s 5 plastičnimi vrečkami po 100 ml<br />

(2 mg/ml)<br />

V03AB15 DuPont Pharma GmbH, Bad<br />

Homburg<br />

N01BB09 Astra Pharmaceutical<br />

Production AB za Astra<br />

N01BB09 Astra Pharmaceutical<br />

Production AB za Astra<br />

N01BB09 Astra Pharmaceutical<br />

Production AB za Astra<br />

N01BB09 Astra Pharmaceutical<br />

Production AB za Astra<br />

N01BB09 Astra Pharmaceutical<br />

Production AB za Astra<br />

N01BB09 Astra Pharmaceutical<br />

Production AB za Astra<br />

N01BB09 Astra Pharmaceutical<br />

Production AB za Astra<br />

N01BB09 Astra Pharmaceutical<br />

Production AB za Astra<br />

d.d., Ljubljana Slovenija<br />

sodelovanju s<br />

F.Hoffmann-La Roche<br />

Ltd., Švica<br />

sodelovanju s<br />

F.Hoffmann-La Roche<br />

Ltd., Švica<br />

sodelovanju s<br />

F.Hoffmann-La Roche<br />

Ltd., Švica<br />

sodelovanju s<br />

F.Hoffmann-La Roche<br />

Ltd., Švica<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Export & Trading AB,<br />

Södertälje<br />

Export & Trading AB,<br />

Södertälje<br />

Export & Trading AB,<br />

Södertälje<br />

Export & Trading AB,<br />

Södertälje<br />

Export & Trading AB,<br />

Södertälje<br />

Export & Trading AB,<br />

Södertälje<br />

Export & Trading AB,<br />

Södertälje<br />

Export & Trading AB,<br />

Södertälje<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Nemčija<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

1564 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

3. 11. 2003 NASONEX mometazon plastenka z zaporko z odmernim<br />

mehanskim pršilnikom (18 g suspenzije<br />

za 120 vpihov -50 µg/vpih)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

R01AD09 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

30. 5. 2002 NATRII CHLORIDI INFUNDIBILE natrijev klorid steklenica po 250 ml (9g/1000ml) B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

30. 5. 2002 NATRII CHLORIDI INFUNDIBILE natrijev klorid plastična vrečka po 250 ml (9g/1000ml) B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

20. 12. 2001 NATRII CHLORIDI INFUNDIBILE natrijev klorid plastenka iz polietilena po 500 ml<br />

(9g/1000ml)<br />

24. 12. 2004 NATRII CHLORIDI INFUNDIBILE natrijev klorid plastenka iz polipropilena po 250 ml<br />

raztopine<br />

24. 12. 2004 NATRII CHLORIDI INFUNDIBILE natrijev klorid plastenka iz polipropilena po 500 ml<br />

raztopine<br />

24. 12. 2004 NATRII CHLORIDI INFUNDIBILE natrijev klorid plastenka iz polipropilena po 100 ml<br />

raztopine<br />

B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 NATRII CHLORIDI INFUNDIBILE natrijev klorid vrečka po 500 ml (9 mg/ml) B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 NATRII CHLORIDI INFUNDIBILE natrijev klorid vrečka po 2000 ml (9 mg/ml) B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 NATRII CHLORIDI INFUNDIBILE natrijev klorid steklenička po 100 ml (9 mg/ml) B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 NATRII CHLORIDI INFUNDIBILE natrijev klorid steklenica po 500 ml (9 mg/ml) B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 NATRII CHLORIDI INFUNDIBILE natrijev klorid vrečka po 1000 ml (9 mg/ml) B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

19. 3. 2004 NATRII CHLORIDI INFUNDIBILE<br />

0,9%<br />

7. 12. 2003 NATRII CHLORIDI INFUNDIBILE<br />

0,9%<br />

7. 12. 2003 NATRII CHLORIDI INFUNDIBILE<br />

0,9%<br />

12. 4. 2001 NATRII CHLORIDI INFUNDIBILE<br />

0,9%<br />

12. 4. 2001 NATRII CHLORIDI INFUNDIBILE<br />

0,9%<br />

24. 6. 2004 NATRII CHLORIDI INFUNDIBILE<br />

0,9%<br />

20. 9. 2004 Natrii chloridi infundibile 0,9%,<br />

MINIBAG PLUS<br />

natrijev klorid plastenka po 100 ml B05BB01 Zavod Republike Slovenije<br />

za transfuzijo krvi,<br />

natrijev klorid plastenka po 250 ml B05BB01 Zavod Republike Slovenije<br />

za transfuzijo krvi,<br />

natrijev klorid plastenka po 500 ml B05BB01 Zavod Republike Slovenije<br />

za transfuzijo krvi,<br />

natrijev klorid steklenica po 500 ml (9g/1000ml) B05BB01 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

natrijev klorid steklenička po 100 ml (9g/1000ml) B05BB01 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

natrijev klorid steklenica po 250 ml raztopine B05BB01 Zavod Republike Slovenije<br />

za transfuzijo krvi,<br />

natrijev klorid zlozˇenka s 30 plastičnimi vrečkami<br />

Minibag plus po 100 ml raztopine<br />

B05BB01 Baxter Healthcare S.A.,<br />

Castelbar, County Mayo,<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Farmacevtski oddelek-<br />

Pharmagena, Ljubljana<br />

Farmacevtski oddelek-<br />

Pharmagena, Ljubljana<br />

Farmacevtski oddelek-<br />

Pharmagena, Ljubljana<br />

Farmacevtski oddelek-<br />

Pharmagena, Ljubljana<br />

Irska za Baxter Export<br />

Corporation,Miami,<br />

Florida,<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

ZDA<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1565


Datum<br />

veljavnosti<br />

Ime zdravila<br />

20. 9. 2004 Natrii chloridi infundibile 0,9%,<br />

MINIBAG PLUS<br />

9. 7. 2003 NATRII CHLORIDI INFUNDIBILE<br />

COMPOSITUM (SOLUTIO<br />

RINGERI)<br />

20. 12. 2001 NATRII CHLORIDI INFUNDIBILE<br />

COMPOSITUM (SOLUTIO<br />

RINGERI)<br />

20. 12. 2001 NATRII CHLORIDI INFUNDIBILE<br />

COMPOSITUM CUM LACTATO<br />

(SOLUTIO HARTMANNI)<br />

9. 7. 2003 NATRII CHLORIDI INFUNDIBILE<br />

COMPOSITUM CUM<br />

LACTATO(SOLUTIO<br />

HARTMANNI)<br />

12. 4. 2001 NATRII CHLORIDI INFUNDIBILE<br />

CUM GLUCOSO I<br />

mednarodno<br />

nelastniško ime<br />

1. 7. 2004 Natrijev hidrogenkarbonat 8,4 % natrijev<br />

hidrogenkarbonat<br />

natrijev klorid zlozˇenka s 30 plastičnimi vrečkami<br />

Minibag plus po 50 ml raztopine<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

B05BB01 Baxter Healthcare S.A.,<br />

Castelbar, County Mayo,<br />

elektroliti steklenica po 500 ml B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

elektroliti plastenka po 500 ml B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

elektroliti plastenka po 500 ml B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

elektroliti steklenica po 500 ml B05BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

glukoza steklenica po 500 ml B05BB02 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

30. 5. 2002 NAVOBAN kapsule tropisetron zlozˇenka s 5 kapsulami (1 × 5 kapsul v<br />

pretisnem omotu)<br />

steklenička po 100 ml raztopine B05BB01 B. Braun Melsungen AG,<br />

Melsungen<br />

30. 5. 2002 NAVOBAN raztopina za<br />

injiciranje 2 mg<br />

30. 5. 2002 NAVOBAN raztopina za<br />

injiciranje 5 mg<br />

7. 5. 2004 NEGRAM nalidiksna kislina zlozˇenka z 28 tabletami v dvojnem traku<br />

(28 × 500 mg)<br />

20. 9. 2004 NELIT 60 prašek (peroralna<br />

rehidracijska sol)<br />

20. 9. 2004 NELIT 60 prašek (peroralna<br />

rehidracijska sol)<br />

20. 9. 2004 NELIT N prašek (peroralna<br />

rehidracijska sol)<br />

A04AA03 Novartis Farmaceutica S. A.,<br />

Barbera del Valles,<br />

Irska za Baxter Export<br />

Corporation,Miami,<br />

Florida,<br />

Barcelona, Španija za<br />

Novartis Pharma AG,<br />

Basel<br />

tropisetron 1 ampula po 2 ml (2 mg/2 ml) A04AA03 Novartis Pharma AG, Basel Švica<br />

tropisetron 10 ampul po 5 ml (5 mg/5 ml) A04AA03 Novartis Pharma AG, Basel Švica<br />

G04AB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

zlozˇenka z 20 vrečkami po 4,66 g praška A07CA LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

zlozˇenka z 10 vrečkami po 23,32 g<br />

praška<br />

7. 12. 2003 NELOREN injekcije 300 mg/ml linkomicin škatla z 10 ampulami po 1 ml<br />

(300 mg/ml)<br />

7. 12. 2003 NELOREN injekcije 600 mg/2 ml linkomicin škatla z 10 ampulami po 2 ml<br />

(600 mg/2 ml)<br />

7. 12. 2003 NELOREN kapsule 500 mg linkomicin škatla s stekleničko po 16 kapsul (16 ×<br />

500 mg)<br />

A07CA LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

zlozˇenka z 10 vrečkami po 28,9 g praška A07CA LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01FF02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01FF02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01FF02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

sodelovanju s Sanofi,<br />

Francija<br />

ZDA<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Nemčija<br />

Švica<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

1566 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

9. 7. 2003 NEO-GILURYTMAL prajmalin 100 × 20 mg C01BA08 Solvay Pharmaceuticals<br />

GmbH, Hannover,<br />

9. 7. 2003 NEO-GILURYTMAL prajmalin 20 × 20 mg C01BA08 Solvay Pharmaceuticals<br />

GmbH, Hannover,<br />

9. 7. 2003 NEO-GILURYTMAL prajmalin 50 × 20 mg C01BA08 Solvay Pharmaceuticals<br />

GmbH, Hannover,<br />

25. 2. 2005 NEODOLPASSE diklofenak steklenica po 250 ml raztopine M01AB55 Fresenius Kabi Austria<br />

GmbH., Graz,<br />

1. 10. 2004 NEOTIGASON kapsule 10 mg acitretin zlozˇenka s 30 kapsulami (6 × 5 kapsul v<br />

pretisnem omotu)<br />

1. 10. 2004 NEOTIGASON kapsule 25 mg acitretin zlozˇenka s 30 kapsulami (6 × 5 kapsul v<br />

pretisnem omotu)<br />

D05BB02 Roche Products Limited,<br />

Welwyn Garden City, Velika<br />

D05BB02 Roche Products Limited,<br />

Welwyn Garden City, Velika<br />

24. 6. 2004 NETROMYCIN 150 mg/1,5 ml netilmicin zlozˇenka z 1 vialo po 1,5 ml raztopine J01GB07 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

24. 6. 2004 NETROMYCIN 50 mg/2 ml netilmicin zlozˇenka z 1 vialo po 2 ml raztopine J01GB07 Schering-Plough Labo N.V.,<br />

Belgija, za<br />

30. 5. 2002 NEUPOGEN injekcije 300 µg filgrastim 5 vial po 1 ml raztopine L03AA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

30. 5. 2002 NEUPOGEN injekcije 480 µg filgrastim 5 vial po 1,6 ml raztopine L03AA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

30. 5. 2002 NEUPOGEN injekcijske brizge<br />

300 µg<br />

30. 5. 2002 NEUPOGEN injekcijske brizge<br />

480 µg<br />

filgrastim 1 napolnjena injekcijska brizga po 1 ml<br />

raztopine<br />

filgrastim 1 napolnjena injekcijska brizga po 1,6 ml<br />

raztopine<br />

24. 6. 2004 NEURONTIN 100 mg gabapentin zlozˇenka z 20 kapsulami ( 2 × 10 kapsul<br />

v pretisnem omotu)<br />

24. 6. 2004 NEURONTIN 100 mg gabapentin zlozˇenka s 100 kapsulami ( 10 × 10<br />

kapsul v pretisnem omotu)<br />

24. 6. 2004 NEURONTIN 300 mg gabapentin zlozˇenka s 100 kapsulami ( 10 × 10<br />

kapsul v pretisnem omotu)<br />

24. 6. 2004 NEURONTIN 300 mg gabapentin zlozˇenka s 50 kapsulami ( 5 × 10 kapsul<br />

v pretisnem omotu)<br />

24. 6. 2004 NEURONTIN 400 mg gabapentin zlozˇenka s 50 kapsulami ( 5 × 10 kapsul<br />

v pretisnem omotu)<br />

24. 6. 2004 NEURONTIN 400 mg gabapentin zlozˇenka s 100 kapsulami ( 10 × 10<br />

kapsul v pretisnem omotu)<br />

L03AA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

L03AA02 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

N03AX12 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

N03AX12 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

N03AX12 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

N03AX12 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

N03AX12 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

N03AX12 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

Britanija za F.<br />

Hoffmann-La Roche<br />

Ltd., Basel<br />

Britanija za F.<br />

Hoffmann-La Roche<br />

Ltd., Basel<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Schering-Plough<br />

Central East AG,<br />

Luzern, Švica<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Avstrija<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

GmbH Berlin, Freiburg Nemčija<br />

GmbH Berlin, Freiburg Nemčija<br />

GmbH Berlin, Freiburg Nemčija<br />

GmbH Berlin, Freiburg Nemčija<br />

GmbH Berlin, Freiburg Nemčija<br />

GmbH Berlin, Freiburg Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1567


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

7. 3. 2002 NEUROTOP 200 mg karbamazepin 50 × 200 mg N03AF01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

7. 3. 2002 NEUROTOP 200 mg karbamazepin 100 × 200 mg N03AF01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

20. 12. 2001 NEUROTOP retard tablete<br />

300 mg<br />

karbamazepin 100 × 300 mg N03AF01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

20. 12. 2001 NEUROTOP retard tablete<br />

300 mg<br />

karbamazepin 50 × 300 mg N03AF01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

20. 12. 2001 NEUROTOP retard tablete<br />

600 mg<br />

karbamazepin 100 × 600 mg N03AF01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

20. 12. 2001 NEUROTOP retard tablete<br />

600 mg<br />

karbamazepin 50 × 600 mg N03AF01 Gerot Pharmazeutika, Dunaj, Avstrija<br />

12. 4. 2001 NICOTINELL TTS 10 nikotin 7 oblizˇev velikosti 10 cm × cm<br />

(17,5 mg/oblizˇ)<br />

N07BA01 Novartis Pharma AG, Basel Švica<br />

12. 4. 2001 NICOTINELL TTS 10 nikotin 21 oblizˇev velikosti 10 cm × cm<br />

(17,5 mg/oblizˇ)<br />

N07BA01 Novartis Pharma AG, Basel Švica<br />

12. 4. 2001 NICOTINELL TTS 10 nikotin 28 oblizˇev velikosti 10 cm × cm<br />

(17,5 mg/oblizˇ)<br />

N07BA01 Novartis Pharma AG, Basel Švica<br />

12. 4. 2001 NICOTINELL TTS 20 nikotin 7 oblizˇev velikosti 20 cm × cm<br />

(35 mg/oblizˇ)<br />

N07BA01 Novartis Pharma AG, Basel Švica<br />

12. 4. 2001 NICOTINELL TTS 20 nikotin 21 oblizˇev velikosti 20 cm × cm<br />

(35 mg/oblizˇ)<br />

N07BA01 Novartis Pharma AG, Basel Švica<br />

12. 4. 2001 NICOTINELL TTS 20 nikotin 28 oblizˇev velikosti 20 cm × cm<br />

(35 mg/oblizˇ)<br />

N07BA01 Novartis Pharma AG, Basel Švica<br />

12. 4. 2001 NICOTINELL TTS 30 nikotin 7 oblizˇev velikosti 30 cm × cm<br />

(52,5 mg/oblizˇ)<br />

N07BA01 Novartis Pharma AG, Basel Švica<br />

12. 4. 2001 NICOTINELL TTS 30 nikotin 21 oblizˇev velikosti 30 cm × cm<br />

(52,5 mg/oblizˇ)<br />

N07BA01 Novartis Pharma AG, Basel Švica<br />

12. 4. 2001 NICOTINELL TTS 30 nikotin 28 oblizˇev velikosti 30 cm × cm<br />

(52,5 mg/oblizˇ)<br />

N07BA01 Novartis Pharma AG, Basel Švica<br />

24. 6. 2004 NIFECARD retard tablete 20 mg nifedipin zlozˇenka s 30 tabletami (3 × 10 tablet v C08CA05 LEK, tovarna farmacevtskih d.d., Ljubljana Slovenija<br />

pretisnem omotu)<br />

in kemičnih izdelkov,<br />

24. 6. 2004 NIFECARD retard tablete 20 mg nifedipin zlozˇenka s 50 tabletami (5 × 10 tablet v C08CA05 LEK, tovarna farmacevtskih d.d., Ljubljana Slovenija<br />

pretisnem omotu)<br />

in kemičnih izdelkov,<br />

24. 6. 2004 NIFECARD tablete 10 mg nifedipin zlozˇenka s 50 tabletami (5 × 10 tablet v C08CA05 LEK, tovarna farmacevtskih d.d., Ljubljana Slovenija<br />

pretisnem omotu)<br />

in kemičnih izdelkov,<br />

24. 6. 2004 NIFECARD tablete 10 mg nifedipin zlozˇenka s 100 tabletami (10 × 10 tablet C08CA05 LEK, tovarna farmacevtskih d.d., Ljubljana Slovenija<br />

v dvojnem traku)<br />

in kemičnih izdelkov,<br />

24. 6. 2004 NIFECARD tablete 10 mg nifedipin zlozˇenka s 500 tabletami (50 × 10 tablet C08CA05 LEK, tovarna farmacevtskih d.d., Ljubljana Slovenija<br />

v dvojnem traku)<br />

in kemičnih izdelkov,<br />

1568 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

4. 1. 2004 NIMBEX 10 mg cisatrakurij škatla s 5 ampulami po 5 ml<br />

(10 mg/5 ml)<br />

4. 1. 2004 NIMBEX 5 mg cisatrakurij škatla s 5 ampulami po 2,5 ml<br />

(5 mg/2,5 ml)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

M03AC11 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

M03AC11 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

12. 1. 2003 NIMOTOP nimodipin 30 × 30 mg C08CA06 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

12. 1. 2003 NIMOTOP S nimodipin steklenička po 50 ml (10 mg/50 ml) C08CA06 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

12. 1. 2003 NIMOTOP S nimodipin 100 × 30 mg C08CA06 Bayer Pharma d.o.o.,<br />

Ljubljana, Slovenija<br />

20. 12. 2001 NITRO-DUR 0,2mg/h gliceriltrinitrat 28 oblizˇev velikosti 10 cm × cm C01DA02 Schering-Plough SA, San<br />

Agustin de Guadalix,<br />

20. 12. 2001 NITRO-DUR 0,4mg/h gliceriltrinitrat 28 oblizˇev velikosti 20 cm × cm C01DA02 Schering-Plough SA, San<br />

Agustin de Guadalix,<br />

20. 12. 2001 NITRO-DUR 0,6mg/h gliceriltrinitrat 28 oblizˇev velikosti 30 cm × cm C01DA02 Schering-Plough SA, San<br />

Agustin de Guadalix,<br />

28. 6. 2001 NITRONAL gliceriltrinitrat zlozˇenka z eno stekleničko po 50 ml<br />

raztopine (50 mg/50 ml)<br />

28. 6. 2001 NITRONAL gliceriltrinitrat zlozˇenka z 10 ampulami po 5 ml<br />

raztopine (5 mg/5 ml)<br />

28. 6. 2001 NITRONAL gliceriltrinitrat zlozˇenka z 10 ampulami po 25 ml<br />

raztopine (25 mg/25 ml)<br />

24. 6. 2005 NITRONG tablete s podaljšanim<br />

sproščanjem 6,5 mg<br />

24. 6. 2005 NITRONG tablete s podaljšanim<br />

sproščanjem 6,5 mg<br />

C01DA02 G. POHL-BOSKAMP GmbH<br />

& Co., Hohenlockstedt<br />

C01DA02 G. POHL-BOSKAMP GmbH<br />

& Co., Hohenlockstedt<br />

C01DA02 G. POHL-BOSKAMP GmbH<br />

& Co., Hohenlockstedt<br />

gliceriltrinitrat zlozˇenka s stekleničko po 25 tablet C01DA02 Krka,tovarna<br />

zdravil,d.d.,Novo mesto v<br />

sodelovanju<br />

gliceriltrinitrat zlozˇenka s stekleničko po 100 tablet C01DA02 Krka,tovarna<br />

zdravil,d.d.,Novo mesto v<br />

sodelovanju<br />

2. 4. 2003 NOLICIN norfloksacin 20 × 400 mg J01MA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

30. 5. 2002 NOLVADEX tamoksifen zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

1. 7. 2004 NORCURON 4 mg vekuronij zlozˇenka s 50 ampulami s praškom in 50<br />

ampulami po 1 ml vode za injekcije<br />

30. 5. 2002 NORDITROPIN 12 IE somatropin,<br />

rekombinantni<br />

humani<br />

1 steklenička s praškom (12 I.E.) in 1<br />

steklenička po 3 ml topila<br />

L02BA01 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

M03AC03 Organon Teknika B.V.,<br />

Boxtel<br />

H01AC01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

v sodelovanju z Bayer<br />

AG, Nemčija<br />

Madrid Španija<br />

Madrid Španija<br />

Madrid Španija<br />

z US Ethicals Inc., Long<br />

Island City, New York<br />

z US Ethicals Inc., Long<br />

Island City, New York<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

ZDA<br />

ZDA<br />

Slovenija<br />

Velika<br />

Britanija<br />

Nizozemska<br />

Danska<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1569


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

30. 5. 2002 NORDITROPIN 4 IE somatropin,<br />

rekombinantni<br />

humani<br />

7. 7. 2002 NORDITROPIN PENSET 12 somatropin,<br />

rekombinantni<br />

humani<br />

7. 7. 2002 NORDITROPIN PENSET 24 somatropin,<br />

rekombinantni<br />

humani<br />

4. 9. 2005 Norditropin SimpleXx<br />

10 mg/1,5 ml<br />

4. 9. 2005 Norditropin SimpleXx<br />

15 mg/1,5 ml<br />

4. 9. 2005 Norditropin SimpleXx<br />

5 mg/1,5 ml<br />

somatropin,<br />

rekombinantni<br />

humani<br />

somatropin,<br />

rekombinantni<br />

humani<br />

somatropin,<br />

rekombinantni<br />

humani<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

1 steklenička s praškom (4 I.E.) in 1<br />

steklenička po 1 ml topila<br />

1 steklenička s praškom (12 I.E.),<br />

injekcijski vlozˇek po 2 ml topila ter<br />

mešalni pribor<br />

1 steklenička s praškom ( 24 I.E.),<br />

injekcijski vlozˇek po 2 ml topila ter<br />

mešalni pribor<br />

zlozˇenka z 1 vlozˇkom za injekcijsko pero<br />

NordiPen po 1,5 ml raztopine<br />

zlozˇenka z 1 vlozˇkom za injekcijsko pero<br />

NordiPen po 1,5 ml raztopine<br />

zlozˇenka z 1 vlozˇkom za injekcijsko pero<br />

NordiPen po 1,5 ml raztopine<br />

7. 7. 2002 NORPROLAC 25 µg/50 µg kinagolid zlozˇenka s 6 tabletami (3 tablete po<br />

25 µg in 3 tablete po 50 µg v pretisnem<br />

omotu)<br />

7. 7. 2002 NORPROLAC 150 µg kinagolid zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

7. 7. 2002 NORPROLAC 75 µg kinagolid zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

29. 11. 2004 NORVASC 10 mg amlodipin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

29. 11. 2004 NORVASC 5 mg amlodipin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

H01AC01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

H01AC01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

H01AC01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

H01AC01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

H01AC01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

H01AC01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

G02CB04 Novartis Pharmaceuticals UK<br />

Ltd., Horsham, Velika<br />

G02CB04 Novartis Pharmaceuticals UK<br />

Ltd., Horsham, Velika<br />

G02CB04 Novartis Pharmaceuticals UK<br />

Ltd., Horsham, Velika<br />

C08CA01 Pfizer s.a., Belgija za Pfizer<br />

International<br />

C08CA01 Pfizer s.a., Belgija za Pfizer<br />

International<br />

Britanija za Novartis<br />

Pharma AG, Basel,<br />

Švica<br />

Britanija za Novartis<br />

Pharma AG, Basel,<br />

Švica<br />

Britanija za Novartis<br />

Pharma AG, Basel,<br />

Švica<br />

Inc., New York, ZDA<br />

Inc., New York, ZDA<br />

28. 6. 2001 NOVESIN 0,4% oksibuprokain steklenička po 10 ml raztopine S01HA02 Ciba Vision Dispersa Ltd.,<br />

Hettlingen<br />

Švica<br />

9. 4. 2004 NOVOCEF tablete 125 mg cefuroksim zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

dvojnem traku)<br />

J01DA06 Pliva d.d., Zagreb Hrvaška<br />

9. 4. 2004 NOVOCEF tablete 250 mg cefuroksim zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

dvojnem traku)<br />

J01DA06 Pliva d.d., Zagreb Hrvaška<br />

9. 4. 2004 NOVOCEF tablete 500 mg cefuroksim zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

dvojnem traku)<br />

J01DA06 Pliva d.d., Zagreb Hrvaška<br />

9. 7. 2003 NOVOLAX bisakodil 30 × 5 mg A06AB02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

1570 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

9. 7. 2003 NOVOLAX bisakodil 6 × 10 mg A06AB02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

19. 3. 2004 NovoNorm tablete 0,5 mg repaglinid zlozˇenka z 90 tabletami (6 × 15 tablet v<br />

pretisnem omotu)<br />

19. 3. 2004 NovoNorm tablete 1 mg repaglinid zlozˇenka z 90 tabletami (6 × 15 tablet v<br />

pretisnem omotu)<br />

19. 3. 2004 NovoNorm tablete 2 mg repaglinid zlozˇenka z 90 tabletami (6 × 15 tablet v<br />

pretisnem omotu)<br />

2. 4. 2003 NovoSeven 60 KIU (1,2 mg) eptakog alfa<br />

(aktivirani)aktivirani<br />

rekombinantni<br />

2. 6. 2005 NOVUXOL klostridiopeptidaza<br />

injekcijska steklenička po 1,2 mg<br />

(60 000 I.E.), injekcijska steklenička po<br />

2,2 ml vode za injekcije, brizga in igla za<br />

injiciranje in 2 alkoholni krpici<br />

A10BH01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10BH01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

A10BH01 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

B02BD08 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

zlozˇenka s tubo po 30 g mazila D03BA02 Knoll AG, mesto proizvodnje<br />

Uetersen, Nemčija /<br />

2. 4. 2003 NOZINAN 100 mg levomepromazin 20 × 100 mg N05AA02 Rhone Poulenc Rorer,<br />

Antony Cedex,<br />

2. 4. 2003 NOZINAN 25 mg levomepromazin 20 × 25 mg N05AA02 Rhone Poulenc Rorer,<br />

Antony Cedex,<br />

2. 4. 2003 NOZINAN 25 mg/1ml injekcije levomepromazin 5 ampul po 1 ml (25 mg/ml) N05AA02 Rhone Poulenc Rorer,<br />

Antony Cedex,<br />

12. 4. 2001 NU-SEALS 300 acetilsalicilna<br />

kislina<br />

12. 4. 2001 NU-SEALS 75 acetilsalicilna<br />

kislina<br />

19. 3. 2004 NUBAIN nalbufin zlozˇenka z 10 ampulami po 2 ml<br />

raztopine (20 mg/2 ml)<br />

100 × 300 mg N02BA01 Eli Lilly and Company<br />

Limited, Basingstoke<br />

14 × 75mg B01AC06 Eli Lilly and Company<br />

Limited, Basingstoke<br />

7. 7. 2002 NUTRIFLEX PERI aminokisline škatla s 5 dvodelnimi vrečkami Twinflex<br />

po 1000 ml raztopine (v spodnjem delu<br />

600 ml raztopine glukoze in v zgornjem<br />

delu 400 ml raztopine z mešanico<br />

aminokislin)<br />

7. 7. 2002 NUTRIFLEX PLUS aminokisline škatla s 5 dvodelnimi vrečkami Twinflex<br />

po 1000 ml raztopine (v spodnjem delu<br />

600 ml raztopine glukoze in v zgornjem<br />

delu 400 ml raztopine z mešanico<br />

aminokislin)<br />

N02AF02 DuPont Pharma GmbH, Bad<br />

Homburg<br />

B05BA10 B. Braun Medical AG,<br />

Emmenbrücke, Švica za<br />

B05BA10 B. Braun Medical AG,<br />

Emmenbrücke, Švica za<br />

Knoll AG,<br />

Ludwigshafen<br />

B. Braun Melsungen<br />

AG, Melsungen,<br />

Nemčija<br />

B. Braun Melsungen<br />

AG, Melsungen,<br />

Nemčija<br />

Slovenija<br />

Danska<br />

Danska<br />

Danska<br />

Danska<br />

Nemčija<br />

Francija<br />

Francija<br />

Francija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1571


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 7. 2002 NUTRIFLEX SPECIAL aminokisline škatla s 5 dvodelnimi vrečkami Twinflex<br />

po 1000 ml raztopine (v spodnjem delu<br />

500 ml raztopine glukoze in v zgornjem<br />

delu 500 ml raztopine z mešanico<br />

aminokislin)<br />

7. 7. 2002 NUTRIFLEX BASAL aminokisline 5 plastičnih vrečk Twinflex po 2000 ml<br />

(32/125)<br />

7. 7. 2002 NUTRIFLEX BASAL aminokisline 5 plastičnih vrečk Twinflex po 1000 ml<br />

(32/125)<br />

7. 7. 2002 NUTRIFLEX PERI aminokisline 5 plastičnih vrečk Twinflex po 2000 ml<br />

(40/80)<br />

7. 7. 2002 NUTRIFLEX PLUS aminokisline 5 plastičnih vrečk Twinflex po 2000 ml<br />

(48/150)<br />

7. 7. 2002 NUTRIFLEX SPECIAL aminokisline 5 plastičnih vrečk Twinflex po 1500 ml<br />

(70/240)<br />

2. 4. 2003 NUTRINEAL PD 4 (hipertonična<br />

raztopina za<br />

peritonealno<br />

dializo)<br />

17. 12. 2004 OCTAGAM humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

17. 12. 2004 OCTAGAM humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

17. 12. 2004 OCTAGAM humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

30. 5. 2002 OCTANATE 1000 koagulacijski<br />

faktor VIII<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

B05BA10 B. Braun Medical AG,<br />

Emmenbrücke, Švica za<br />

B05BA10 B. Braun Melsungen AG,<br />

Melsungen<br />

B05BA10 B. Braun Melsungen AG,<br />

Melsungen<br />

B05BA10 B. Braun Melsungen AG,<br />

Melsungen<br />

B05BA10 B. Braun Melsungen AG,<br />

Melsungen<br />

B05BA10 B. Braun Melsungen AG,<br />

Melsungen<br />

Viaflex vrečka po 2000 ml B05DB Baxter Healthcare<br />

Corporation, Irska, za Baxter<br />

zlozˇenka s stekleničko po 200 ml<br />

raztopine (10 g/200 ml)<br />

zlozˇenka s stekleničko po 50 ml<br />

raztopine (2,5 g/50 ml)<br />

zlozˇenka s stekleničko po 100 ml<br />

raztopine (5 g/100 ml)<br />

zlozˇenka z 1 vialo s praškom, 1 vialo po<br />

10 ml vode za injekcije in priborom za<br />

raztapljanje in injiciranje (injekcijska<br />

brizga, dvojna pretočna injekcijska igla in<br />

filtrska igla, sistem za infuzijo in<br />

2 tampona prepojena z alkoholom)<br />

J06BA02 Octapharma Pharmazeutika<br />

Produktionsges.m.b.H.,<br />

J06BA02 Octapharma Pharmazeutika<br />

Produktionsges.m.b.H.,<br />

J06BA02 Octapharma Pharmazeutika<br />

Produktionsges.m.b.H.,<br />

B02BD02 Octapharma Pharmazeutika<br />

Produktionsges.m.b.H.,<br />

B. Braun Melsungen<br />

AG, Melsungen,<br />

Nemčija<br />

Export Corporation,<br />

Miami, Florida, ZDA<br />

Dunaj, Avstrija za<br />

Octapharma AG,<br />

Lachen, Švica<br />

Dunaj, Avstrija za<br />

Octapharma AG,<br />

Lachen, Švica<br />

Dunaj, Avstrija za<br />

Octapharma AG,<br />

Lachen, Švica<br />

Dunaj, Avstrija za<br />

Octapharma AG,<br />

Lachen, Švica<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

1572 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

30. 5. 2002 OCTANATE 500 koagulacijski<br />

faktor VIII<br />

8. 5. 2003 OCTANINE F 500 koagulacijski<br />

faktor IX<br />

30. 5. 2002 OCTAPHARMA 20% HUMANI<br />

ALBUMIN<br />

30. 5. 2002 OCTAPHARMA 20% HUMANI<br />

ALBUMIN<br />

30. 5. 2002 OCTAPHARMA 5% HUMANI<br />

ALBUMIN<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

zlozˇenka z 1 vialo s praškom, 1 vialo po<br />

10 ml vode za injekcije in priborom za<br />

raztapljanje in injiciranje (injekcijska<br />

brizga, dvojna pretočna injekcijska igla in<br />

filtrska igla, sistem za infuzijo in 2<br />

tampona prepojena z alkoholom)<br />

zlozˇenka z eno vialo s praškom za<br />

pripravo raztopine (500 I.E.), eno vialo<br />

po 5 ml vode za injekcije, eno injekcijsko<br />

brizgo, eno dvojno pretočno injekcijsko<br />

iglo, eno brizgo s filtrom in dvema<br />

tamponoma prepojenima z etanolom<br />

albumin 1 infuzijska steklenička po 100 ml<br />

raztopine<br />

albumin 1 infuzijska steklenička po 50 ml<br />

raztopine<br />

albumin 1 infuzijska steklenica po 250 ml<br />

raztopine<br />

28. 6. 2001 OLFEN 100 SR DEPOCAPS diklofenak zlozˇenka z 20 kapsulami (2 × 10 kapsul<br />

v pretisnem omotu)<br />

B02BD02 Octapharma Pharmazeutika<br />

Produktionsges.m.b.H.,<br />

B02BD04 Octapharma Pharmazeutika<br />

Produktionsges.m.b.H.,<br />

B05AA01 Octapharma Pharmazeutika<br />

Prod. Ges.mbH, Dunaj,<br />

B05AA01 Octapharma Pharmazeutika<br />

Prod. Ges.mbH, Dunaj,<br />

B05AA01 Octapharma Pharmazeutika<br />

Prod. Ges.mbH, Dunaj,<br />

Dunaj, Avstrija za<br />

Octapharma AG,<br />

Lachen, Švica<br />

Dunaj, Avstrija za<br />

Octapharma AG,<br />

Lachen, Švica<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

M01AB05 MEPHA Ltd., Aesch, Basel Švica<br />

20. 12. 2001 OLICEF prašek za infuzijo 2 g ceftriakson 5 vial po 2 g J01DA13 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

20. 12. 2001 OLICEF prašek za infuzijo 2 g ceftriakson 1 viala po 2 g J01DA13 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 4. 2001 OLICEF prašek za injekcijsko<br />

raztopino 1 g<br />

12. 4. 2001 OLICEF prašek za injekcijsko<br />

raztopino 1 g<br />

12. 4. 2001 OLICEF prašek za injekcijsko<br />

raztopino 250 mg<br />

12. 4. 2001 OLICEF prašek za injekcijsko<br />

raztopino 250 mg<br />

ceftriakson 50 stekleničk po 1g J01DA13 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

ceftriakson 10 stekleničk po 1g J01DA13 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

ceftriakson 50 stekleničk po 250 mg J01DA13 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

ceftriakson 10 stekleničk po 250 mg J01DA13 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 OLIVIN tablete 10 mg enalapril 90 × 10 mg C09AA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 OLIVIN tablete 10 mg enalapril 20 × 10 mg C09AA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 OLIVIN tablete 20 mg enalapril 90 × 20 mg C09AA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 OLIVIN tablete 20 mg enalapril 20 × 20 mg C09AA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1573


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

3. 11. 2003 OLIVIN tablete 5 mg enalapril 90 × 5 mg C09AA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 OLIVIN tablete 5 mg enalapril 20 × 5 mg C09AA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 5. 2004 OMNIC tamsulozin zlozˇenka s 30 kapsulami po 0,4 mg (3 ×<br />

10 kapsul v pretisnem omotu)<br />

11. 2. 2003 OMNIDROX cefadroksil steklenička s praškom za pripravo 100 ml<br />

suspenzije (250 mg/5 ml)<br />

G04CA02 Yamanouchi Europe<br />

B.V.Hogemaat, Meppel,<br />

Nizozemska<br />

J01DA09 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

11. 2. 2003 OMNIDROX cefadroksil 16 × 500 mg J01DA09 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

24. 6. 2004 OMNIPAQUE 240 mg I/ml joheksol zlozˇenka s 25 vialami po 20 ml raztopine V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

24. 6. 2004 OMNIPAQUE 240 mg I/ml joheksol zlozˇenka z 10 vialami po 10 ml<br />

raztopine<br />

V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

24. 6. 2004 OMNIPAQUE 240 mg I/ml joheksol zlozˇenka s 6 vialami po 20 ml raztopine V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

24. 6. 2004 OMNIPAQUE 240 mg I/ml joheksol zlozˇenka s 6 vialami po 200 ml raztopine V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

24. 6. 2004 OMNIPAQUE 240 mg I/ml joheksol zlozˇenka z 10 vialami po 50 ml<br />

raztopine<br />

24. 6. 2004 OMNIPAQUE 300 mg I/ml joheksol zlozˇenka z 10 vialami po 100 ml<br />

raztopine<br />

V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

24. 6. 2004 OMNIPAQUE 300 mg I/ml joheksol zlozˇenka s 6 vialami po 20 ml raztopine V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

24. 6. 2004 OMNIPAQUE 300 mg I/ml joheksol zlozˇenka s 25 vialami po 20 ml raztopine V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

24. 6. 2004 OMNIPAQUE 300 mg I/ml joheksol zlozˇenka z 10 vialami po 10 ml<br />

raztopine<br />

24. 6. 2004 OMNIPAQUE 300 mg I/ml joheksol zlozˇenka z 10 vialami po 50 ml<br />

raztopine<br />

V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

za Yamanouchi Pharma<br />

SpA Carugate (Mi),<br />

Italija<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

sodelovanju z Bristol-<br />

Myers Squibb, New<br />

York, ZDA<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

1574 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

24. 6. 2004 OMNIPAQUE 350 mg I/ml joheksol zlozˇenka z 10 vialami po 50 ml<br />

raztopine<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

24. 6. 2004 OMNIPAQUE 350 mg I/ml joheksol zlozˇenka s 6 vialami po 20 ml raztopine V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

24. 6. 2004 OMNIPAQUE 350 mg I/ml joheksol zlozˇenka z 10 vialami po 100 ml<br />

raztopine<br />

V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

24. 6. 2004 OMNIPAQUE 350 mg I/ml joheksol zlozˇenka s 6 vialami po 200 ml raztopine V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

24. 6. 2004 OMNIPAQUE 350 mg I/ml joheksol zlozˇenka s 25 vialami po 20 ml raztopine V08AB02 Nycomed Imaging AS, Oslo,<br />

Norveška in Nycomed<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

Ireland Ltd., Irska za<br />

Nycomed Austria<br />

GmbH<br />

20. 12. 2001 OMNISCAN gadodiamid 10 stekleničk po 20 ml (0,5 mmol/ml) V08CA03 Nycomed Imaging AS, Oslo, Norveška<br />

20. 12. 2001 OMNISCAN gadodiamid 10 stekleničk po 15 ml (0,5 mmol/ml) V08CA03 Nycomed Imaging AS, Oslo, Norveška<br />

20. 12. 2001 OMNISCAN gadodiamid 10 stekleničk po 10 ml (0,5 mmol/ml) V08CA03 Nycomed Imaging AS, Oslo, Norveška<br />

20. 12. 2001 OMNISCAN gadodiamid 10 stekleničk po 5 ml (0,5 mmol/ml) V08CA03 Nycomed Imaging AS, Oslo, Norveška<br />

2. 4. 2003 ONCOVIN injekcije 1 mg vinkristin viala po 1 mg in viala po 10 ml topila L01CA02 LEK, d.d., Ljubljana v<br />

sodelovanju z Eli Lilly &<br />

Co., Indianapolis, ZDA<br />

17. 12. 2004 ONILAT injekcije 4 mg/2 ml ondansetron zlozˇenka s 5 ampulami po 2 ml raztopine A04AA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

17. 12. 2004 ONILAT injekcije 8 mg/4 ml ondansetron zlozˇenka s 5 ampulami po 4 ml raztopine A04AA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

17. 12. 2004 ONILAT tablete 4 mg ondansetron zlozˇenka z 10 tabletami (1 × 10 tablet v A04AA01 LEK, tovarna farmacevtskih d.d., Ljubljana Slovenija<br />

pretisnem omotu)<br />

in kemičnih izdelkov,<br />

17. 12. 2004 ONILAT tablete 8 mg ondansetron zlozˇenka z 10 tabletami (1 × 10 tablet v A04AA01 LEK, tovarna farmacevtskih d.d., Ljubljana Slovenija<br />

pretisnem omotu)<br />

in kemičnih izdelkov,<br />

19. 3. 2004 ONKOTRONE injekcije<br />

mitoksantron zlozˇenka z eno vialo po 10 ml raztopine L01DB07 Arzneimittelwerk Dresden za Asta Medica AG, Nemčija<br />

20 mg/10 ml<br />

GmbH, Radebeul, Nemčija, Dresden<br />

1. 7. 2004 OPERIL P kapljice za nos 0,025% oksimetazolin zlozˇenka s plastenko po 10 ml raztopine R01AA05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

1. 7. 2004 OPERIL kapljice za nos 0,05% oksimetazolin zlozˇenka s plastenko po 10 ml raztopine R01AA05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

9. 7. 2003 ORACEF cefaleksin 100 × 500 mg J01DA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

9. 7. 2003 ORACEF cefaleksin 16 × 500 mg J01DA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1575


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

9. 4. 2004 ORBENIN injekcije kloksacilin zlozˇenka s 50 prebodnimi stekleničkami s<br />

praškom<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

J01CF02 Pliva d.d., Zagreb Hrvaška<br />

9. 4. 2004 ORBENIN kapsule kloksacilin zlozˇenka s stekleničko po 16 kapsul J01CF02 Pliva d.d., Zagreb Hrvaška<br />

7. 3. 2002 ORONAZOL tablete ketokonazol 20 × 200mg J02AB02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

11. 2. 2003 OSPEN fenoksimetilpenicilin<br />

11. 2. 2003 OSPEN 1000 fenoksimetilpenicilin<br />

11. 2. 2003 OSPEN 1000 fenoksimetilpenicilin<br />

11. 2. 2003 OSPEN 1500 fenoksimetilpenicilin<br />

11. 2. 2003 OSPEN 500 fenoksimetilpenicilin<br />

11. 2. 2003 OSPEN 750 fenoksimetilpenicilin<br />

steklenička po 25 ml (150 000 I.E./ml) J01CE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

30 × 1 000 000 I.E. J01CE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

steklenička po 150 ml<br />

(1 000 000 I.E./6 ml)<br />

J01CE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

30 × 1 500 000 I.E. J01CE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

30 × 500 000 I.E. J01CE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

zlozˇenka s stekleničko po 60 ml<br />

suspenzije in plastično odmerno zˇličko<br />

J01CE02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

sodelovanju z<br />

Biochemie, Avstrija<br />

sodelovanju z<br />

Biochemie, Avstrija<br />

sodelovanju z<br />

Biochemie, Avstrija<br />

sodelovanju z<br />

Biochemie, Avstrija<br />

sodelovanju z<br />

Biochemie, Avstrija<br />

sodelovanju z<br />

Biochemie, Avstrija<br />

12. 1. 2003 OTOMYCIN 10 kloramfenikol steklenička po 10 ml (100 mg/ml) S02AA01 Pliva d.d., Zagreb Hrvaška<br />

20. 9. 2004 OTRIVIN kapljice za nos 0,5‰ ksilometazolin zlozˇenka s plastenko po 10 ml raztopine R01AA07 Novartis Consumer Health<br />

SA, Nyon,<br />

20. 9. 2004 OTRIVIN kapljice za nos 1‰ ksilometazolin zlozˇenka s plastenko po 10 ml raztopine R01AA07 Novartis Consumer Health<br />

SA, Nyon,<br />

20. 9. 2004 OTRIVIN pršilo za nos 1 ‰ ksilometazolin zlozˇenka s plastenko po 10 ml raztopine R01AA07 Novartis Consumer Health<br />

SA, Nyon,<br />

21. 5. 2004 OVESTIN krema estriol tuba po 30 g vaginalne kreme (1 mg/g) in<br />

aplikator<br />

G03CA04 Organon (Ireland) Ltd.,<br />

Swords, Co. Dublin,Irska /<br />

Slovenija<br />

Švica<br />

Švica<br />

Švica<br />

N.V. Organon, Oss Nizozemska<br />

30. 5. 2002 OVESTIN tablete 1 mg estriol 30 × 1mg G03CA04 N. V. Organon, Oss, Nizozemska<br />

30. 5. 2002 OVESTIN tablete 2 mg estriol 30 × 2mg G03CA04 N. V. Organon, Oss, Nizozemska<br />

30. 5. 2002 OVESTIN vagitoriji estriol 15 vaginalnih globul po 0,5mg G03CA04 N. V. Organon, Oss, Nizozemska<br />

28. 6. 2001 OXSORALEN kapsule metoksalen za<br />

sistemsko<br />

zdravljenje<br />

28. 6. 2001 OXSORALEN raztopina metoksalen za<br />

lokalno<br />

zdravljenje<br />

50 × 10 mg D05BA02 Gerot Pharmazeutika, Dunaj, Avstrija<br />

steklenička po 50 ml dermalne raztopine<br />

(1,5mg/1ml)<br />

7. 12. 2003 PALIN kapsule 200 mg pipemidna kislina škatla z 20 kapsulami po 200 mg (2 × 10<br />

kapsul v pretisnem omotu)<br />

D05AD02 Gerot Pharmazeutika, Dunaj, Avstrija<br />

G04AB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

1576 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 12. 2003 PALIN tablete 400 mg pipemidna kislina škatla s stekleničko po 20 tablet<br />

(20 × 400 mg)<br />

7. 12. 2003 PALIN vagitoriji 200 mg pipemidna kislina škatla z 10 vaginalnimi globulami v<br />

dvojnem traku (10 × 200 mg)<br />

4. 1. 2004 PANADOL paracetamol škatla z 12 tabletami po 500 mg (1 × 12<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 PANADOL paracetamol škatla z 24 tabletami po 500 mg ( 2 × 12<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 PANADOL EXTRA paracetamol škatla z 24 tabletami (2 × 12 tablet v<br />

pretisnem omotu) (500 mg paracetamola<br />

+ 65 mg kofeina/tableto)<br />

4. 1. 2004 PANADOL EXTRA paracetamol škatla z 12 tabletami (1 × 12 tablet v<br />

pretisnem omotu) (500 mg paracetamola<br />

+ 65 mg kofeina/tableto)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

G04AB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

G04AB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N02BE01 SmithKline Beecham<br />

Consumer Healthcare,<br />

N02BE01 SmithKline Beecham<br />

Consumer Healthcare,<br />

N02BE51 SmithKline Beecham<br />

Consumer Healthcare,<br />

N02BE51 SmithKline Beecham<br />

Consumer Healthcare,<br />

3. 11. 2003 PANATUS butamirat steklenička po 200 ml (4 mg/5 ml) R05DB13 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 PANATUS butamirat 10 × 20 mg R05DB13 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 PANATUS FORTE butamirat steklenička po 200 ml (7,5 mg/5 ml) R05DB13 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 PANATUS FORTE butamirat 10 × 50 mg R05DB13 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

18. 1. 2001 PANAZE 10.000 multiencimski<br />

pripravki (lipaze,<br />

proteaze)<br />

20 kapsul A09AA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

2. 4. 2003 PARACETAMOLI SUPP. 120 mg paracetamol 10 × 120 mg N02BE01 Lekarna Ljubljana, PE<br />

Galenski laboratorij,<br />

21. 5. 2004 PAVULON 4 mg/2 ml raztopina<br />

za injiciranje<br />

19. 3. 2004 PEDITRACE (kombinacije<br />

elektrolitov z<br />

drugimi<br />

pripravki)<br />

9. 7. 2003 PEKTROL izosorbidmononitrat<br />

9. 7. 2003 PEKTROL izosorbidmononitrat<br />

pankuronij zlozˇenka s 50 ampulami po 2 ml<br />

raztopine<br />

zlozˇenka z 10 vialami po 10 ml<br />

koncentrata<br />

M03AC01 Organon Teknika B.V.,<br />

Boxtel<br />

B05XA31 Fresenius Kabi Halden<br />

ANS,Norveška za Fresenius<br />

30 × 40 mg C01DA14 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

30 × 60 mg C01DA14 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

24. 6. 2005 PELENTAN tablete 300 mg etilbiskumacetat zlozˇenka s stekleničko po 10 tablet B01AA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 PENACTAM prašek za peroralno<br />

suspenzijo<br />

sultamicilin steklenička s praškom za pripravo 60 ml<br />

suspenzije (250mg/5ml)<br />

J01CR04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Brentford Velika<br />

Britanija<br />

Brentford Velika<br />

Britanija<br />

Brentford Velika<br />

Britanija<br />

Brentford Velika<br />

Britanija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Ljubljana Slovenija<br />

Kabi AB,Švedska/<br />

Fresenius Kabi<br />

Deutschland Gmbh<br />

Nizozemska<br />

Nemčija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1577


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

28. 6. 2001 PENACTAM tablete sultamicilin 10 × 375 mg J01CR04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

24. 6. 2004 PENTILIN pentoksifilin zlozˇenka s 5 ampulami po 5 ml raztopine<br />

(100 mg/5 ml)<br />

C04AD03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 PERMAX 0,05 mg pergolid 30 × 0,05 mg N04BC02 Eli Lilly and Company<br />

Limited, Basingstoke<br />

28. 6. 2001 PERMAX 0,25 mg pergolid 30 × 0,25 mg N04BC02 Eli Lilly and Company<br />

Limited, Basingstoke<br />

28. 6. 2001 PERMAX 1 mg pergolid 30 × 1 mg N04BC02 Eli Lilly and Company<br />

Limited, Basingstoke<br />

28. 6. 2001 PERSANTIN injekcije dipiridamol 5 ampul po 2 ml raztopine (10mg/2ml) B01AC07 Dr. Karl Thomae GmbH za<br />

Boehringer Ingelheim<br />

28. 6. 2001 PERSANTIN oblozˇene tablete dipiridamol 50 × 75 mg B01AC07 Dr. Karl Thomae GmbH za<br />

Boehringer Ingelheim<br />

9. 4. 2004 PHEMITON tablete 200 mg metilfenobarbital zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

9. 4. 2004 PHEMITON tablete 30 mg metilfenobarbital zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

21. 5. 2004 PHENOBARBITON NATRIUM<br />

injekcije<br />

21. 5. 2004 PHENOBARBITON tablete<br />

100 mg<br />

fenobarbital zlozˇenka s 5 ampulami s praškom in 5<br />

ampulami po 2 ml vode za injekcije<br />

fenobarbital zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

21. 5. 2004 PHENOBARBITON tablete 15 mg fenobarbital zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

International GmbH,<br />

Ingelheim am Rhein<br />

International GmbH,<br />

Ingelheim am Rhein<br />

Slovenija<br />

Slovenija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Nemčija<br />

Nemčija<br />

N03AA01 Pliva d.d., Zagreb Hrvaška<br />

N03AA01 Pliva d.d., Zagreb Hrvaška<br />

N03AA02 Pliva d.d., Zagreb Hrvaška<br />

N03AA02 Pliva d.d., Zagreb Hrvaška<br />

N03AA02 Pliva d.d., Zagreb Hrvaška<br />

1. 7. 2004 PHOLCODIN kapsule 10 mg folkodin zlozˇenka s stekleničko po 20 kapsul R05DA08 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

1. 7. 2004 PHOLCODIN peroralna raztopina<br />

15 mg/15 ml<br />

1. 7. 2004 PHOLCODIN peroralna raztopina<br />

za otroke 4 mg/5 ml<br />

folkodin zlozˇenka s stekleničko po 150 ml<br />

raztopine<br />

folkodin zlozˇenka s stekleničko po 60 ml<br />

raztopine<br />

7. 5. 2004 PIMIDEL pipemidna kislina zlozˇenka z 20 kapsulami po 200 mg (2 ×<br />

10 kapsul v pretisnem omotu)<br />

14. 12. 2005 PLATINEX cisplatin zlozˇenka s prebodno stekleničko po<br />

20 ml raztopine (10 mg/20 ml)<br />

14. 12. 2005 PLATINEX cisplatin zlozˇenka s prebodno stekleničko po<br />

100 ml raztopine (50 mg/100 ml)<br />

R05DA08 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

R05DA08 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

G04AB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

L01XA01 Bristol-Myers Squibb S.p.A.,<br />

Sermoneta (Latina),<br />

L01XA01 Bristol-Myers Squibb S.p.A.,<br />

Sermoneta (Latina),<br />

Italija za Bristol-Myers<br />

Squibb Products S.A.,<br />

Baar<br />

Italija za Bristol-Myers<br />

Squibb Products S.A.,<br />

Baar<br />

Slovenija<br />

Švica<br />

Švica<br />

1578 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

14. 12. 2005 PLATINEX cisplatin zlozˇenka s prebodno stekleničko po<br />

50 ml raztopine (25 mg/50 ml)<br />

29. 11. 2004 PLAVIX tablete 75 mg klopidogrel zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

24. 6. 2004 PLEOSTAT tablete 400 mg etidronska kislina zlozˇenka s 56 tabletami (8 × 7 tablet v<br />

pretisnem omotu)<br />

24. 6. 2004 PLEOSTAT tablete 400 mg etidronska kislina zlozˇenka s 14 tabletami (2 × 7 tablet v<br />

pretisnem omotu)<br />

3. 7. 2005 PLIVADON paracetamol zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

9. 4. 2004 PLIVIT A injekcije retinol<br />

(vitamin A)<br />

9. 7. 2003 PLIVIT B1 injekcije 100 mg tiamin<br />

(vitamin B1)<br />

9. 7. 2003 PLIVIT B1 injekcije 250 mg tiamin<br />

(vitamin B1)<br />

9. 7. 2003 PLIVIT B1 tablete tiamin<br />

(vitamin B1)<br />

9. 7. 2003 PLIVIT B6 injekcije 250 mg piridoksin<br />

(vitamin B6)<br />

9. 7. 2003 PLIVIT B6 tablete piridoksin<br />

(vitamin B6)<br />

20. 9. 2004 PLIVIT D3 holekalciferol<br />

(vitamin D3)<br />

9. 7. 2003 PLODIN izosorbidmononitrat<br />

9. 7. 2003 PLODIN izosorbidmononitrat<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

L01XA01 Bristol-Myers Squibb S.p.A.,<br />

Sermoneta (Latina),<br />

B01AC04 Sanofi Winthrop Industrie,<br />

Francija in Lek d.d.<br />

M05BA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

M05BA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Italija za Bristol-Myers<br />

Squibb Products S.A.,<br />

Baar<br />

Slovenija/Sanofi-<br />

Synthelabo-Lek d.o.o.,<br />

Ljubljana<br />

Švica<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

N02BE51 Pliva d.d., Zagreb Hrvaška<br />

zlozˇenka s 5 ampulami po 1 ml raztopine A11CA01 Pliva d.d., Zagreb Hrvaška<br />

50 ampul po 1 ml (100 mg/ml) A11DA01 Pliva d.d., Zagreb Hrvaška<br />

50 ampul po 2 ml (250 mg/2 ml) A11DA01 Pliva d.d., Zagreb Hrvaška<br />

20 × 50 mg A11DA01 Pliva d.d., Zagreb Hrvaška<br />

50 ampul po 5 ml (250 mg/5 ml) A11HA02 Pliva d.d., Zagreb Hrvaška<br />

20 × 25 mg A11HA02 Pliva d.d., Zagreb Hrvaška<br />

zlozˇenka s stekleničko (z zaporko s<br />

kapalko) po 10 ml raztopine<br />

(4000 I.E./ml)<br />

17. 12. 2004 PORTAL kapsule 20 mg fluoksetin zlozˇenka s 14 kapsulami (2 × 7 kapsul v<br />

pretisnem omotu)<br />

17. 12. 2004 PORTAL kapsule 20 mg fluoksetin zlozˇenka z 28 kapsulami (4 × 7 kapsul v<br />

pretisnem omotu)<br />

A11CC05 Pliva d.d., Zagreb Hrvaška<br />

30 × 20 mg C01DA14 Jaka- 80 AD- Radoviš,<br />

Farmacevtska, kozmetična<br />

30 × 40 mg C01DA14 Jaka- 80 AD- Radoviš,<br />

Farmacevtska, kozmetična<br />

N06AB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

N06AB03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 11. 2003 PORTALAK SIRUP laktuloza steklenica po 500 ml (66,7 g/100 ml) A06AD11 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

9. 4. 2004 PRAXITEN 15 oksazepam zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

in dietetična industrija,<br />

Radoviš<br />

in dietetična industrija,<br />

Radoviš<br />

Republika<br />

Makedonija<br />

Republika<br />

Makedonija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Hrvaška<br />

N05BA04 Pliva d.d., Zagreb Hrvaška<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1579


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

9. 4. 2004 PRAZINE drazˇeji 100 mg promazin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

9. 4. 2004 PRAZINE drazˇeji 25 mg promazin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

9. 4. 2004 PRAZINE injekcije 100 mg promazin zlozˇenka z 10 ampulami po 2 ml<br />

raztopine<br />

9. 4. 2004 PRAZINE injekcije 50 mg promazin zlozˇenka z 10 ampulami po 1 ml<br />

raztopine<br />

20. 9. 2004 PRE-PAR 10 mg tablete ritodrin zlozˇenka s 100 tabletami (4 × 25 tablet v<br />

pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

N05AA03 Pliva d.d., Zagreb Hrvaška<br />

N05AA03 Pliva d.d., Zagreb Hrvaška<br />

N05AA03 Pliva d.d., Zagreb Hrvaška<br />

N05AA03 Pliva d.d., Zagreb Hrvaška<br />

G02CA01 Belupo zdravila in kozmetika<br />

d.o.o., Koprivnica,<br />

20. 9. 2004 PRE-PAR 50 mg injekcije ritodrin zlozˇenka z 1 ampulo po 5 ml raztopine G02CA01 Belupo zdravila in kozmetika<br />

d.o.o., Koprivnica,<br />

12. 7. 2004 PREDUCTAL trimetazidin zlozˇenka s 60 tabletami po 20 mg (2 ×<br />

30 tablet v pretisnem omotu)<br />

12. 1. 2003 PREGNYL humani horionski<br />

gonadotropin<br />

12. 1. 2003 PREGNYL humani horionski<br />

gonadotropin<br />

8. 11. 2001 PREGOMIN hranila brez<br />

vsebnosti<br />

fenilalanina<br />

19. 3. 2004 PREMARIN 0,625 konjugirani<br />

estrogeni<br />

19. 3. 2004 PREMARIN 1,25 konjugirani<br />

estrogeni<br />

3 viale s praškom (5000 I.E.) in 3 ampule<br />

po 1 ml topila<br />

6 vial s praškom (1500 I.E.) in 6 ampul<br />

po 1 ml topila<br />

C01EB15 Les Laboratoires Servier<br />

Industrie, Gidy,<br />

pločevinka po 400 g praška V06CA Milupa GmbH & Co.K.G.,<br />

Friedrichsdorf,<br />

zlozˇenka z 28 tabletami (1 × 28 tablet v<br />

pretisnem omotu)<br />

zlozˇenka z 28 tabletami (1 × 28 tablet v<br />

pretisnem omotu)<br />

30. 5. 2002 PREPIDIL dinoproston zlozˇenka z brizgo po 3 g gela<br />

(0,5 mg/3 g)<br />

Hrvaška v sodelovanju<br />

s Solvay<br />

Pharmaceuticals<br />

Hrvaška v sodelovanju<br />

s Solvay<br />

Pharmaceuticals<br />

Nizozemska<br />

Nizozemska<br />

Francija<br />

G03GA01 N. V. Organon, Oss, Nizozemska<br />

G03GA01 N. V. Organon, Oss, Nizozemska<br />

G03CA57 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

G03CA57 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

G02AD02 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

sodelovanju z Wyeth-<br />

Lederle Pharma GmbH,<br />

Dunaj<br />

sodelovanju z Wyeth-<br />

Lederle Pharma GmbH,<br />

Dunaj<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

28. 6. 2001 PREXANIL perindopril 30 × 4 mg C09AA04 Les Laboratoires Servier<br />

Industrie, Gidy,<br />

Francija<br />

1. 7. 2004 PRIMIDON primidon zlozˇenka s 100 tabletami (10 × 10 tablet<br />

v pretisnem omotu)<br />

N03AA03 Pliva d.d., Zagreb Hrvaška<br />

24. 6. 2004 PRIMOLUT-NOR noretisteron zlozˇenka s steklenim vsebnikom po 20<br />

tablet (20 × 5 mg)<br />

G03DC02 Schering AG, Berlin, Nemčija<br />

19. 3. 2004 PRIMOTREN injekcije 80/400 sulfametoksazol<br />

in trimetoprim<br />

zlozˇenka z 10 ampulami po 5 ml<br />

raztopine (400 mg sulfametoksazola +<br />

80 mg trimetoprima/5 ml)<br />

J01EE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Nemčija<br />

Avstrija<br />

Avstrija<br />

d.d., Ljubljana Slovenija<br />

1580 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

19. 3. 2004 PRIMOTREN suspenzija sulfametoksazol<br />

in trimetoprim<br />

19. 3. 2004 PRIMOTREN tablete 80/400 sulfametoksazol<br />

in trimetoprim<br />

19. 3. 2004 PRIMOTREN tablete za otroke<br />

20/100<br />

sulfametoksazol<br />

in trimetoprim<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

zlozˇenka s steklenim vsebnikom po<br />

100 ml suspenzije (200 mg<br />

sulfametoksazola + 40 mg<br />

trimetoprima/5 ml)<br />

zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu) (1 tableta vsebuje<br />

400 mg sulfametoksazola in 80 mg<br />

trimetoprima)<br />

zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu) (1 tableta vsebuje<br />

100 mg sulfametoksazola in 20 mg<br />

trimetoprima)<br />

J01EE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01EE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

J01EE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

20. 12. 2001 PRINZIDE lizinopril 28 tablet C09BA03 MERCK SHARP & DOHME-<br />

CHIBRET A.G.,<br />

1. 10. 2004 PROCULIN nafazolin zlozˇenka s stekleničko (s kapalnim<br />

nastavkom) z 10 ml raztopine<br />

4. 1. 2004 PROLEKOFEN injekcije<br />

35 mg/10 ml<br />

propafenon škatla z 10 ampulami po 10 ml raztopine<br />

(35 mg/10 ml)<br />

4. 1. 2004 PROLEKOFEN tablete 150 mg propafenon škatla s 50 tabletami po 150 mg (5 × 10<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 PROLEKOFEN tablete 300 mg propafenon škatla s 50 tabletami po 300 mg (5 × 10<br />

tablet v pretisnem omotu)<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Francija Francija<br />

S01GA51 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

C01BC03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

C01BC03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

C01BC03 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

7. 7. 2002 PRONTOBARIO 60% barijev sulfat plastenka po 5 l suspenzije (0,6 g/ml) V08BA01 Bracco S.p.A., Milano Italija<br />

7. 7. 2002 PRONTOBARIO COLON barijev sulfat vrečka po 400 g praška (940,15mg/1g),<br />

cevka in rektalni kateter<br />

V08BA01 Bracco S.p.A., Milano Italija<br />

7. 7. 2002 PRONTOBARIO HD barijev sulfat skodelica po 340 g praška (984,5mg/1g) V08BA01 Bracco S.p.A., Milano Italija<br />

19. 3. 2004 PROPECIA finasterid zlozˇenka z 28 tabletami (4 × 7 tablet v<br />

pretisnem omotu)<br />

D11AX10 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

1. 10. 2004 PROPILTIOURACIL propiltiouracil zlozˇenka s stekleničko po 20 tablet H03BA02 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

2. 6. 2005 PROPOFOL 1% FRESENIUS propofol zlozˇenka s steklenim vsebnikom po<br />

50 ml emulzije<br />

2. 6. 2005 PROPOFOL 1% FRESENIUS propofol zlozˇenka s steklenim vsebnikom po<br />

100 ml emulzije<br />

2. 6. 2005 PROPOFOL 1% FRESENIUS propofol zlozˇenka s 5 ampulami po 20 ml<br />

emulzije<br />

N01AX10 Fresenius Kabi Austria<br />

GmbH, Graz, Avstrija /<br />

N01AX10 Fresenius Kabi Austria<br />

GmbH, Graz, Avstrija /<br />

N01AX10 Fresenius Kabi Austria<br />

GmbH, Graz, Avstrija /<br />

Fresenius Kabi<br />

Deutschland, Bad<br />

Homburg, Nemčija<br />

Fresenius Kabi<br />

Deutschland, Bad<br />

Homburg, Nemčija<br />

Fresenius Kabi<br />

Deutschland, Bad<br />

Homburg, Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1581


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

19. 3. 2004 PROPRANOLOL tablete 40 mg propranolol zlozˇenka s steklenim vsebnikom po 50<br />

tablet<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

C07AA05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

10. 11. 2002 PROREKTAL S SIRUP laktuloza steklenička po 100 ml A06AD11 Lek, d.d., Ljubljana v<br />

sodelovanju s Fresenius<br />

10. 11. 2002 PROREKTAL S SIRUP laktuloza steklenica po 500 ml A06AD11 Lek, d.d., Ljubljana v<br />

sodelovanju s Fresenius<br />

7. 5. 2004 PROSTAPHLIN oksacilin zlozˇenka z 1 vialo s praškom (1 g) J01CF04 Bristol-Myers Squibb S.p.A.,<br />

Sermoneta (Latina),<br />

7. 5. 2004 PROSTAPHLIN oksacilin zlozˇenka z 1 vialo s praškom (500 mg) J01CF04 Bristol-Myers Squibb S.p.A.,<br />

Sermoneta (Latina),<br />

7. 5. 2004 PROSTAPHLIN oksacilin zlozˇenka z 1vialo s praškom (250 mg) J01CF04 Bristol-Myers Squibb S.p.A.,<br />

Sermoneta (Latina),<br />

23. 6. 2003 PROSTIGMIN neostigmin 50 ampul po 1 ml (0,5 mg/ml) N07AA01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

16. 12. 2002 PROSTIN 15 M karboprost zlozˇenka z eno ampulo po 1 ml<br />

raztopine<br />

16. 12. 2002 PROSTIN E2 vaginalne tablete dinoproston zlozˇenka s 4 vaginalnimi tabletami<br />

(4 × 3 mg)<br />

G02AD04 Pharmacia & Upjohn Co.,<br />

Kalamazoo, ZDA za<br />

G02AD02 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

16. 12. 2002 PROSTIN E2 vaginalni gel 1 mg dinoproston zlozˇenka z brizgo po 3 g gela (1 mg/3 g) G02AD02 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

16. 12. 2002 PROSTIN E2 vaginalni gel 2 mg dinoproston zlozˇenka z brizgo po 3 g gela (2 mg/3 g) G02AD02 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

29. 11. 2004 PROVERA 100 mg tablete medroksiprogesteron<br />

29. 11. 2004 PROVERA 500 mg tablete medroksiprogesteron<br />

16. 12. 2002 PROVERA tablete 10 mg medroksiprogesteron<br />

16. 12. 2002 PROVERA tablete 5 mg medroksiprogesteron<br />

16. 12. 2002 PROVERA zrnca 1g medroksiprogesteron<br />

zlozˇenka s steklenim vsebnikom po 100<br />

tablet<br />

zlozˇenka s steklenim vsebnikom po 20<br />

tablet<br />

L02AB02 Pharmacia & Upjohn SpA,<br />

Marino del Tronto, Ascoli<br />

L02AB02 Pharmacia & Upjohn SpA,<br />

Marino del Tronto, Ascoli<br />

zlozˇenka s 30 tabletami G03DA02 Pharmacia & Upjohn SpA,<br />

Marino del Tronto, Ascoli<br />

zlozˇenka s 24 tabletami G03DA02 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

zlozˇenka z 10 vrečkami po 10 g zrnc<br />

(1g/10 g)<br />

L02AB02 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

d.d., Ljubljana Slovenija<br />

Pharma Austria GmbH,<br />

Graz, Avstrija<br />

Pharma Austria GmbH,<br />

Graz, Avstrija<br />

Pharmacio & Upjohn<br />

S.A., Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Piceno, Italija za<br />

Pharmacio & Upjohn<br />

S.A.<br />

Piceno, Italija za<br />

Pharmacio & Upjohn<br />

S.A.<br />

Piceno, Italija za<br />

Pharmacio & Upjohn<br />

S.A.<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Italija<br />

Italija<br />

Italija<br />

Švica<br />

Luksemburg<br />

Luksemburg<br />

Luksemburg<br />

1582 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

16. 12. 2002 PROVERA zrnca 200 mg medroksiprogesteron<br />

16. 12. 2002 PROVERA zrnca 500 mg medroksiprogesteron<br />

29. 11. 2004 PROVISC hialuronska<br />

kislina<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

zlozˇenka s 50 vrečkami po 4 g zrnc<br />

(200 mg/4 g)<br />

zlozˇenka z 10 vrečkami po 10 g zrnc<br />

(500 mg/10 g)<br />

zlozˇenka z napolnjeno injekcijsko brizgo<br />

po 0,55 ml raztopine in injekcijsko iglo<br />

(10 mg/ml)<br />

25. 2. 2005 PROZAC kapsule fluoksetin zlozˇenka z 28 kapsulami (2 × 14 kapsul<br />

v pretisnem omotu)<br />

25. 2. 2005 PROZAC kapsule fluoksetin zlozˇenka s 14 kapsulami (1 × 14 kapsul v<br />

pretisnem omotu)<br />

7. 7. 2002 PULMICORT TURBUHALER budezonid zlozˇenka s plastičnim vsebnikom z<br />

odmernim ventilom in ustnikom (za 100<br />

odmerkov-200 µg/odmerek)<br />

7. 7. 2002 PULMICORT TURBUHALER budezonid zlozˇenka s plastičnim vsebnikom z<br />

odmernim ventilom in ustnikom (za 200<br />

odmerkov-100 µg/odmerek)<br />

7. 7. 2002 PULMICORT TURBUHALER budezonid zlozˇenka s plastičnim vsebnikom z<br />

odmernim ventilom in ustnikom (za 200<br />

odmerkov-400 µg/odmerek)<br />

7. 7. 2002 PULMICORT TURBUHALER budezonid zlozˇenka s plastičnim vsebnikom z<br />

odmernim ventilom in ustnikom (za 100<br />

odmerkov-400 µg/odmerek)<br />

7. 7. 2002 PULMICORT TURBUHALER budezonid zlozˇenka s plastičnim vsebnikom z<br />

odmernim ventilom in ustnikom (za 200<br />

odmerkov-200 µg/odmerek)<br />

L02AB02 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

L02AB02 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

S01KA01 S.A. Alcon-Couvreur N.V.,<br />

Puurs, Belgija za Alcon<br />

N06AB03 Eli Lilly and Company<br />

Limited, Basingstoke, Velika<br />

N06AB03 Eli Lilly and Company<br />

Limited, Basingstoke, Velika<br />

R03BA02 ASTRA, Pharmaceutical<br />

production, Södertälje<br />

R03BA02 ASTRA, Pharmaceutical<br />

production, Södertälje<br />

R03BA02 ASTRA, Pharmaceutical<br />

production, Södertälje<br />

R03BA02 ASTRA, Pharmaceutical<br />

production, Södertälje<br />

R03BA02 ASTRA, Pharmaceutical<br />

production, Södertälje<br />

10. 11. 2002 PULMOVENT budezonid pršilnik po 10 ml (200 razprškov) R03BA02 Medis d.o.o., v sodelovanju z<br />

IG Sprühtechnik GmbH<br />

23. 6. 2003 PULMOZYME dornaza alfa<br />

(rekombinantna)<br />

23. 6. 2003 PULMOZYME dornaza alfa<br />

(rekombinantna)<br />

23. 6. 2003 PUREGON 100 I.E. folitropin beta<br />

(rekombinantni<br />

FSH)<br />

23. 6. 2003 PUREGON 150 I.E. folitropin beta<br />

(rekombinantni<br />

FSH)<br />

6 polietilenskih ampul po 2,5 ml<br />

(2,5mg/2,5ml)<br />

škatla s 30 polietilenskimi ampulami po<br />

2,5 ml (2,5mg/2,5ml)<br />

ampula s praškom (100 I.E.) in ampula<br />

po 1 ml topila<br />

ampula s praškom (150 I.E.) in ampula<br />

po 1 ml topila<br />

R05CB13 Genentech Inc., South San<br />

Francisco, ZDA za<br />

R05CB13 Genentech Inc., South San<br />

Francisco, ZDA za<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Pharmaceuticals Ltd.,<br />

Hünenberg, Švica<br />

Britanija za Eli Lilly<br />

(Suisse) SA, Vernier,<br />

Švica<br />

Britanija za Eli Lilly<br />

(Suisse) SA, Vernier,<br />

Švica<br />

Nemčija<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

G03GA06 N. V. Organon, Oss, Nizozemska<br />

G03GA06 N. V. Organon, Oss, Nizozemska<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1583


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

23. 6. 2003 PUREGON 50 I.E. folitropin beta<br />

(rekombinantni<br />

FSH)<br />

23. 6. 2003 PUREGON 75 I.E. folitropin beta<br />

(rekombinantni<br />

FSH)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

ampula s praškom (50 I.E.) in ampula po<br />

1 ml topila<br />

viala s praškom (75 I.E.) in ampula po<br />

1 ml topila<br />

G03GA06 N. V. Organon, Oss, Nizozemska<br />

G03GA06 N. V. Organon, Oss, Nizozemska<br />

12. 1. 2003 PURI-NETHOL merkaptopurin 25 × 50 mg L01BB02 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

7. 3. 2002 PYLORID ranitidin<br />

bizmutov citrat<br />

19. 3. 2004 PYRAZINAMID pirazinamid zlozˇenka s steklenim vsebnikom po 100<br />

tablet (100 × 500 mg)<br />

23. 10. 2003 RABIVAC cepivo proti<br />

steklini z<br />

inaktiviranimi<br />

virusi<br />

28 × 400 mg A02BA07 Glaxo Wellcome Operations,<br />

Greenford<br />

zlozˇenka s 5 vialami s praškom,<br />

5 ampulami po 1 ml vode za injekcije in<br />

5 injekcijskimi brizgami<br />

J04AK01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J07BG01 Chiron Behring GmbH &<br />

Co., Marburg<br />

10. 11. 2002 RANITAL 75 mg TABLETE ranitidin 10 × 75 mg A02BA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

4. 1. 2004 RANITAL injekcije 50 mg/2 ml ranitidin škatla s 5 ampulami po 2 ml<br />

(50 mg/2 ml)<br />

4. 1. 2004 RANITAL tablete 150 mg ranitidin škatla z 20 tabletami po 150 mg (2 × 10<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 RANITAL tablete 300 mg ranitidin škatla s 30 tabletami po 300 mg (3 × 10<br />

tablet v pretisnem omotu)<br />

8. 11. 2001 RAVIDOL zˇvečljive tablete<br />

500 mg<br />

A02BA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

A02BA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

A02BA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

hidrotalcit 20 zˇvečljivih tablet po 500 mg A02AD04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

4. 1. 2004 RAXAR 400 mg grepafloksacin škatla z 10 tabletami po 400 mg (2 × 5<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 RAXAR 600 mg grepafloksacin škatla z 10 tabletami po 600 mg (2 × 5<br />

tablet v pretisnem omotu)<br />

29. 11. 2004 RECOFOL propofol zlozˇenka s 5 ampulami po 20 ml<br />

emulzije (10 mg/ml)<br />

29. 11. 2004 RECOFOL propofol zlozˇenka z vialo po 100 ml emulzije<br />

(10 mg/ml)<br />

29. 11. 2004 RECOFOL propofol zlozˇenka z vialo po 50 ml emulzije<br />

(10 mg/ml)<br />

J01MA11 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

J01MA11 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

N01AX10 Leiras Oy, Turku, Finska, za<br />

Schering AG, Berlin,<br />

N01AX10 Leiras Oy, Turku, Finska, za<br />

Schering AG, Berlin,<br />

N01AX10 Leiras Oy, Turku, Finska, za<br />

Schering AG, Berlin,<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Slovenija<br />

Nemčija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

1584 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

30. 5. 2002 RECORMON SE 10.000 I.E. eritropoetin beta 5 vial s praškom (10.000 I.E./31,2 mg) in<br />

5 injekcijskih brizg po 1 ml vode za<br />

injekcije<br />

30. 5. 2002 RECORMON SE 1000 I.E. eritropoetin beta 5 vial s praškom (1.000 I.E./31,2 mg) in<br />

5 injekcijskih brizg po 1 ml vode za<br />

injekcije<br />

30. 5. 2002 RECORMON SE 2000 I.E. eritropoetin beta 5 vial s praškom (2.000 I.E./31,2 mg) in<br />

5 injekcijskih brizg po 1 ml vode za<br />

injekcije<br />

30. 5. 2002 RECORMON SE 5000 I.E. eritropoetin beta 5 vial s praškom (5.000 I.E./31,2 mg) in<br />

5 injekcijskih brizg po 1 ml vode za<br />

injekcije<br />

12. 1. 2003 REDERGIN FORTE RAZTOPINA<br />

3 mg/ml<br />

ergoloid mezilat steklenička po 30 ml (3mg/ml) in<br />

plastična odmerna kapalka<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

B03XA01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

B03XA01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

B03XA01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

B03XA01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

C04AE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

12. 1. 2003 REDERGIN INJEKCIJE 0,3 mg/ml ergoloid mezilat 50 ampul po 1 ml (0,3 mg/ml) C04AE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

12. 1. 2003 REDERGIN RAZTOPINA<br />

1 mg/ml<br />

ergoloid mezilat steklenička po 50 ml (1 mg/ml) in<br />

plastična odmerna kapalka<br />

C04AE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

12. 1. 2003 REDERGIN TABLETE 1,5 mg ergoloid mezilat 20 × 1,5 mg C04AE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

12. 1. 2003 REDERGIN TABLETE 4,5 mg ergoloid mezilat 20 × 4,5 mg C04AE01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

29. 11. 2004 REDUCTIL 10 mg sibutramin zlozˇenka z 28 kapsulami (2 × 14 kapsul<br />

v pretisnem omotu)<br />

A08AA10 Knoll AG, Ludwigshafen, Nemčija<br />

29. 11. 2004 REDUCTIL 15 mg sibutramin zlozˇenka z 28 kapsulami (2 × 14 kapsul<br />

v pretisnem omotu)<br />

A08AA10 Knoll AG, Ludwigshafen, Nemčija<br />

30. 5. 2002 REGAINE 2% minoksidil zlozˇenka s stekleničko po 60 ml<br />

raztopine in 3 aplikatorji<br />

28. 9. 2005 RELENZA zanamivir zlozˇenka s 5 okroglimi ploščicami<br />

(Rotadiski) v plastičnem vsebniku (vsak<br />

Rotadisk vsebuje 4 odmerke) in plastično<br />

napravo za inhaliranje (Diskhaler)<br />

29. 11. 2004 REMERON 30 mg mirtazapin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

29. 11. 2004 REMERON 45 mg mirtazapin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

D11AX01 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

J05AH01 Glaxo Wellcome Production,<br />

Evreux, Francija za<br />

28. 6. 2001 RENICIN 300 mg roksitromicin 5 tablet po 300 mg J01FA06 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

18. 12. 2003 RENICIN tablete 150 mg roksitromicin zlozˇenka s 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

N06AX11 N. V. Organon, Oss, Nizozemska<br />

N06AX11 N. V. Organon, Oss, Nizozemska<br />

J01FA06 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1585


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

18. 12. 2003 RENICIN tablete 50 mg roksitromicin zlozˇenka s 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

J01FA06 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

11. 2. 2003 RETAFER zˇelezov(II) sulfat 30 × 40 mg B03AA07 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

11. 2. 2003 RETAFER zˇelezov(II) sulfat 30 × 100 mg B03AA07 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 4. 2001 RETAFOL tablete zˇelezov(II) sulfat zlozˇenka s 30 tabletami (15 rumenih in<br />

15 oranzˇnih tablet)<br />

8. 5. 2003 RETARPEN benzatinijev<br />

benzilpenicilinat<br />

1. 7. 2004 RETAXIM filmsko oblozˇene<br />

tablete 10 mg<br />

B03AD03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

d.d., Ljubljana Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

zlozˇenka s 100 vialami s praškom J01CE08 Biochemie GmbH, Kundl Avstrija<br />

tamoksifen zlozˇenka s stekleničko po 30 tablet L02BA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 REVIA naltrekson 28 × 50 mg V03AB30 DuPont Pharma GmbH, Bad<br />

Homburg<br />

7. 5. 2004 RHESOGAMMA P humani<br />

imunoglobulin<br />

anti-D (Rh)<br />

zlozˇenka z eno ampulo po 1,5 ml<br />

raztopine (100-170 mg/ml)<br />

12. 1. 2003 RIFATER izoniazid zlozˇenka s 100 tabletami (5 × 20 tablet v<br />

pretisnem omotu)<br />

1. 7. 2004 RIMACTAN rifampicin zlozˇenka s 100 kapsulami (10 × 10<br />

kapsul v pretisnem omotu)<br />

1. 7. 2004 RIMACTAN rifampicin zlozˇenka s 16 kapsulami (2 × 8 kapsul v<br />

pretisnem omotu)<br />

1. 10. 2004 RINGERJEV LAKTAT raztopina<br />

za intravensko infundiranje, BP<br />

12. 3. 2004 Ringerjeva raztopina Braun,<br />

raztopina za intravensko<br />

infundiranje<br />

12. 3. 2004 Ringerjeva raztopina Braun,<br />

raztopina za intravensko<br />

infundiranje<br />

12. 3. 2004 Ringerjeva raztopina Braun,<br />

raztopina za izpiranje<br />

12. 3. 2004 Ringerjeva raztopina Braun,<br />

raztopina za izpiranje<br />

28. 6. 2001 RINGERJEVA RAZTOPINA DAB<br />

7 BRAUN, raztopina za izpiranje<br />

elektroliti škatla z 20 vrečkami Clear-Flex po<br />

500 ml raztopine<br />

J06BB01 Centeon Pharma GmbH,<br />

Marburg, Nemčija za<br />

J04AM02 Gruppo Lepetit S.p.A.,<br />

Anagni, Italija za Hoechst<br />

Centeon Pharma<br />

GmbH, Dunaj, Avstrija<br />

Marion Roussel GmbH,<br />

Dunaj, Avstrija<br />

Slovenija<br />

Nemčija<br />

J04AB02 Pliva d.d., Zagreb Hrvaška<br />

J04AB02 Pliva d.d., Zagreb Hrvaška<br />

B05BB01 Bieffe Medital S.p.A., Italija<br />

ali Bieffe Medital<br />

natrijev klorid plastenka po 500 ml raztopine B05BB01 B. Braun Melsungen AG,<br />

Melsungen<br />

natrijev klorid plastenka po 1000 ml raztopine B05BB01 B. Braun Melsungen AG,<br />

Melsungen<br />

natrijev klorid plastična vrečka po 3000 ml raztopine B05CB10 B. Braun Medical AG,<br />

Emmenbrücke, Švica za<br />

natrijev klorid plastična vrečka po 5000 ml raztopine B05CB10 B. Braun Medical AG,<br />

Emmenbrücke, Švica za<br />

(solne raztopine<br />

za izpiranje)<br />

plastenka po 500 ml B05CB10 B. Braun Melsungen AG,<br />

Melsungen<br />

S.A., Španija za Baxter<br />

Export Corporation,<br />

Miami<br />

B. Braun Melsungen<br />

AG, Melsungen,<br />

Nemčija<br />

B. Braun Melsungen<br />

AG, Melsungen,<br />

Nemčija<br />

ZDA<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

1586 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

28. 6. 2001 RINGERJEVA RAZTOPINA DAB<br />

7 BRAUN, raztopina za izpiranje<br />

mednarodno<br />

nelastniško ime<br />

(solne raztopine<br />

za izpiranje)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

plastenka po 1000 ml B05CB10 B. Braun Melsungen AG,<br />

Melsungen<br />

28. 6. 2001 RISPERDAL 1 mg risperidon 60 × 1 mg N05AX08 Janssen-Cilag, Beerse Belgija<br />

28. 6. 2001 RISPERDAL 1 mg risperidon 20 × 1 mg N05AX08 Janssen-Cilag, Beerse Belgija<br />

28. 6. 2001 RISPERDAL 2 mg risperidon 20 × 2 mg N05AX08 Janssen-Cilag, Beerse Belgija<br />

28. 6. 2001 RISPERDAL 2 mg risperidon 60 × 2 mg N05AX08 Janssen-Cilag, Beerse Belgija<br />

28. 6. 2001 RISPERDAL 3 mg risperidon 60 × 3 mg N05AX08 Janssen-Cilag, Beerse Belgija<br />

28. 6. 2001 RISPERDAL 3 mg risperidon 20 × 3 mg N05AX08 Janssen-Cilag, Beerse Belgija<br />

28. 6. 2001 RISPERDAL 4 mg risperidon 60 × 4 mg N05AX08 Janssen-Cilag, Beerse Belgija<br />

28. 6. 2001 RISPERDAL 4 mg risperidon 20 × 4 mg N05AX08 Janssen-Cilag, Beerse Belgija<br />

19. 3. 2004 RISPERDAL peroralna raztopina risperidon zlozˇenka s stekleničko po 100 ml<br />

N05AX08 Janssen Pharmaceutica N.V.,<br />

Belgija<br />

raztopine (1 mg/ml) in plastično odmerno<br />

kapalko<br />

Beerse,<br />

12. 3. 2004 RIVOTRIL tablete 0,5 mg klonazepam zlozˇenka s stekleničko po 50 tablet N03AE01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

12. 3. 2004 RIVOTRIL tablete 2 mg klonazepam zlozˇenka s stekleničko po 30 tablet N03AE01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

18. 12. 2003 ROACCUTANE kapsule 10 mg izotretinoin zlozˇenka s 30 kapsulami (3 × 10 kapsul v<br />

pretisnem omotu)<br />

18. 12. 2003 ROACCUTANE kapsule 20 mg izotretinoin zlozˇenka s 30 kapsulami (3 × 10 kapsul v<br />

pretisnem omotu)<br />

D10BA01 R. P. Scherer GmbH,<br />

Eberbach, Nemčija za<br />

D10BA01 R. P. Scherer GmbH,<br />

Eberbach, Nemčija za<br />

7. 5. 2004 ROCALTROL kapsule 0,25 µg kalcitriol zlozˇenka s stekleničko s 100 kapsulami A11CC04 R. P. Scherer GmbH,<br />

Eberbach, Nemčija za<br />

7. 5. 2004 ROCALTROL kapsule 0,5 µg kalcitriol zlozˇenka s stekleničko s 100 kapsulami A11CC04 R. P. Scherer GmbH,<br />

Eberbach, Nemčija za<br />

7. 7. 2002 RODANOL tablete 1 g nabumeton 20 × 1g M01AX01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

12. 4. 2001 RODANOL S nabumeton zlozˇenka z 20 tabletami za peroralno<br />

raztopino<br />

7. 7. 2002 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

7. 7. 2002 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

7. 7. 2002 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

7. 7. 2002 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

zlozˇenka z 1 vialo po 1 ml raztopine<br />

(9.000.000 I.E./1ml)<br />

zlozˇenka z 1 vialo po 1 ml raztopine<br />

(3.000.000 I.E./1ml)<br />

zlozˇenka z 1 napolnjeno injekcijsko<br />

brizgo po 0,5 ml raztopine<br />

(4.500.000 I.E./0,5ml) in injekcijsko iglo<br />

zlozˇenka z 1 vialo po 1 ml raztopine<br />

(4.500.000 I.E./1ml)<br />

M01AX01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

Nemčija<br />

Švica<br />

Švica<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1587


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 7. 2002 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

7. 7. 2002 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

7. 7. 2002 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

7. 3. 2002 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

7. 3. 2002 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

7. 3. 2002 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

7. 3. 2002 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

19. 3. 2004 ROFERON-A interferon alfa-2a,<br />

rekombinantni<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

zlozˇenka z 1 napolnjeno injekcijsko<br />

brizgo po 0,5 ml raztopine<br />

(9.000.000 I.E./0,5ml) in injekcijsko iglo<br />

zlozˇenka z 1 napolnjeno injekcijsko<br />

brizgo po 0,5 ml raztopine<br />

(3.000.000 I.E./0,5ml) in injkecijsko iglo<br />

zlozˇenka z 1 vialo po 3 ml raztopine<br />

(18.000.000 I.E./3ml)<br />

1 steklenička po 3.000.000 I.E. in<br />

1 ampula po 1 ml vehikla<br />

1 steklenička po 9.000.000 I.E. in<br />

1 ampula po 1 ml vehikla<br />

1 steklenička po 18.000.000 I.E. in<br />

1 ampula po 1 ml vehikla<br />

1 steklenička po 4.500.000 I.E.in<br />

1 ampula po 1 ml vehikla<br />

zlozˇenka z 1 napolnjeno injekcijsko<br />

brizgo po 0,5 ml (6.000.000 I.E./0,5ml)<br />

in injekcijsko iglo<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

L03AB04 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

30. 5. 2002 ROZAMET 1% krema metronidazol zlozˇenka s tubo po 25 g kreme (1%) D06BX01 Jadran, Galenski laboratorij<br />

d.d., Rijeka, Hrvaška<br />

4. 1. 2004 RUTACID hidrotalcit škatla z 20 tabletami po 500 mg (2 × 10<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 RUTACID hidrotalcit škatla z 60 tabletami po 500 mg (6 × 10<br />

tablet v pretisnem omotu)<br />

19. 3. 2004 RYTMONORM 150 mg propafenon zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

19. 3. 2004 RYTMONORM 300 mg propafenon zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

15. 1. 2004 RYTMONORM raztopina za<br />

injiciranje<br />

propafenon zlozˇenka s 5 ampulami po 20 ml<br />

raztopine<br />

A02AD04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

A02AD04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Švica<br />

Slovenija<br />

Slovenija<br />

C01BC03 Knoll AG, Ludwigshafen, Nemčija<br />

C01BC03 Knoll AG, Ludwigshafen, Nemčija<br />

C01BC03 Knoll AG, Ludwigshafen, Nemčija<br />

9. 7. 2003 SAB SIMPLEX suspenzija simetikon zlozˇenka s stekleničko (z zaporko s<br />

kapalko) po 30 ml suspenzije<br />

A02DA01 Parke-Davis GmbH, Berlin Nemčija<br />

9. 7. 2003 SAB SIMPLEX zˇvečljive tablete 50<br />

tabl<br />

dimetikon zlozˇenka s 50 tabletami A02DA01 Parke-Davis GmbH, Berlin Nemčija<br />

9. 7. 2003 SAB SIMPLEX zˇvečljive tablete 20<br />

tabl<br />

9. 7. 2003 SAB SIMPLEX zˇvečljive tablete<br />

100 tabl<br />

dimetikon zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

A02DA01 Parke-Davis GmbH, Berlin Nemčija<br />

dimetikon zlozˇenka s 100 tabletami A02DA01 Parke-Davis GmbH, Berlin Nemčija<br />

1588 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

18. 1. 2001 SAFEBAG 93 G (pripravki za<br />

filtracijo krvi)<br />

2. 4. 2003 SAIZEN somatropin,<br />

rekombinantni<br />

humani<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

2 vrečki po 5000 ml raztopine B05ZB Biosol S.p.A., Sondalo Italija<br />

viala s praškom (4 I.E.) in ampula po<br />

1 ml topila<br />

2. 6. 2005 SALIPAX fluoksetin zlozˇenka z 10 kapsulami po 20 mg v<br />

pretisnem omotu<br />

18. 7. 2005 SALOFALK gastrorezistentne<br />

tablete 250 mg<br />

18. 7. 2005 SALOFALK gastrorezistentne<br />

tablete 250 mg<br />

18. 7. 2005 SALOFALK gastrorezistentne<br />

tablete 500 mg<br />

18. 7. 2005 SALOFALK gastrorezistentne<br />

tablete 500 mg<br />

mesalazin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

mesalazin zlozˇenka s 100 tabletami (10 × 10 tablet<br />

v pretisnem omotu)<br />

mesalazin zlozˇenka s 100 tabletami (10 × 10 tablet<br />

v pretisnem omotu)<br />

mesalazin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

18. 7. 2005 SALOFALK rektalna suspenzija mesalazin zlozˇenka s 7 klizmami po 60 g suspenzije<br />

(7 × 1 klizma v pretisnem omotu)<br />

18. 7. 2005 SALOFALK svečke 250 mg mesalazin zlozˇenka s 30 svečkami (6 × 5 svečk v<br />

dvojnem traku)<br />

18. 7. 2005 SALOFALK svečke 250 mg mesalazin zlozˇenka z 10 svečkami (2 × 5 svečk v<br />

dvojnem traku)<br />

18. 7. 2005 SALOFALK svečke 500 mg mesalazin zlozˇenka s 30 svečkami (6 × 5 svečk v<br />

dvojnem traku)<br />

18. 7. 2005 SALOFALK svečke 500 mg mesalazin zlozˇenka z 10 svečkami (2 × 5 svečk v<br />

dvojnem traku)<br />

24. 6. 2004 SARIDON paracetamol zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu) (1 tableta vsebuje<br />

250 mg paracetamola, 150 mg<br />

propifenazona in 50 mg kofeina)<br />

H01AC01 Laboratoires Serono SA Švica<br />

N06AB03 MEPHA Ltd., Aesch, Basel Švica<br />

A07EC02 Dr. Falk Pharma GmbH,<br />

Freiburg<br />

A07EC02 Dr. Falk Pharma GmbH,<br />

Freiburg<br />

A07EC02 Dr. Falk Pharma GmbH,<br />

Freiburg<br />

A07EC02 Dr. Falk Pharma GmbH,<br />

Freiburg<br />

A07EC02 Dr. Falk Pharma GmbH,<br />

Freiburg<br />

A07EC02 Dr. Falk Pharma GmbH,<br />

Freiburg<br />

A07EC02 Dr. Falk Pharma GmbH,<br />

Freiburg<br />

A07EC02 Dr. Falk Pharma GmbH,<br />

Freiburg<br />

A07EC02 Dr. Falk Pharma GmbH,<br />

Freiburg<br />

N02BE51 Roche Nicholas S.A.,<br />

Gaillard, Francija za<br />

12. 11. 2004 SCANDONEST 2 % injekcije mepivakain zlozˇenka s 50 vlozˇki po 1,8 ml raztopine N01BB53 Specialites Septodont, Saint<br />

Maur des Fosses<br />

12. 11. 2004 SCANDONEST 3 % injekcije mepivakain zlozˇenka s 50 vlozˇki po 1,8 ml raztopine N01BB03 Specialites Septodont, Saint<br />

Maur des Fosses<br />

12. 1. 2003 SELDIAR loperamid 20 × 2 mg A07DA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

28. 6. 2001 SELDIAR peroralna raztopina loperamid steklenička po 30 ml raztopine<br />

(1mg/5ml)<br />

2. 6. 2005 SERETIDE DISKUS 50/100 salmeterol zlozˇenka s plastično napravo s praškom<br />

za inhaliranje (za 60 odmerkov)<br />

A07DA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

R03AK06 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

F. Hoffmann-La Roche<br />

Ltd., Basel, Švica<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Cedex Francija<br />

Cedex Francija<br />

sodelovanju z Janssen<br />

Pharmaceutica, Belgija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1589


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

2. 6. 2005 SERETIDE DISKUS 50/250 salmeterol zlozˇenka s plastično napravo s praškom<br />

za inhaliranje (za 60 odmerkov)<br />

2. 6. 2005 SERETIDE DISKUS 50/500 salmeterol zlozˇenka s plastično napravo s praškom<br />

za inhaliranje (za 60 odmerkov)<br />

18. 12. 2003 SEREVENT pršilnik salmeterol zlozˇenka z vsebnikom s suspenzijo z<br />

zaporko z odmernim ventilom in<br />

ustnikom (za 60 odmerkov)<br />

24. 6. 2004 SEROQUEL kvetiapin zlozˇenka s 60 tabletami po 200 mg (6 ×<br />

10 tablet v pretisnem omotu)<br />

24. 6. 2004 SEROQUEL kvetiapin zlozˇenka s 60 tabletami po 25 mg (6 ×<br />

10 tablet v pretisnem omotu)<br />

24. 6. 2004 SEROQUEL kvetiapin zlozˇenka z 8 tabletami v pretisnem<br />

omotu (6 tablet po 25 mg in 2 tableti po<br />

100 mg)<br />

24. 6. 2004 SEROQUEL kvetiapin zlozˇenka s 60 tabletami po 100 mg (6 ×<br />

10 tablet v pretisnem omotu)<br />

22. 6. 2005 SEROXAT 20 mg tablete paroksetin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

22. 6. 2005 SEROXAT 30 mg tablete paroksetin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

12. 3. 2004 Sestavljena raztopina natrijevega<br />

laktata za intravensko<br />

infudiranje(Hart.raz.)<br />

12. 3. 2004 Sestavljena raztopina natrijevega<br />

laktata za intravensko<br />

infundiranje(Hart.raz.)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

R03AK06 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

R03AK06 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

R03AC12 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

N05AH04 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

N05AH04 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

N05AH04 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

N05AH04 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

N06AB05 Belupo, zdravila in<br />

kozmetika d.o.o.,Koprivnica,<br />

N06AB05 Belupo, zdravila in<br />

kozmetika d.o.o.,Koprivnica,<br />

elektroliti plastenka po 1000 ml raztopine B05BB01 B. Braun Melsungen AG,<br />

Melsungen<br />

elektroliti plastenka po 500 ml raztopine B05BB01 B. Braun Melsungen AG,<br />

Melsungen<br />

8. 11. 2001 SEVIT prašek holestiramin 50 vrečk po 5 g praška za peroralno<br />

raztopino(4g/5g)<br />

C10AC01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 6. 2005 SEVORANE sevofluran zlozˇenka s steklenico po 250 ml tekočine N01AB08 Abbott Laboratories Ltd.,<br />

Queenborough, Kent,<br />

3. 11. 2003 SINECOD raztopina butamirat steklenička po 20 ml (5 mg/ml) in<br />

kapalka<br />

R05DB13 Novartis Consumer Health<br />

SA, Nyon,<br />

3. 11. 2003 SINECOD tablete butamirat 10 × 50 mg R05DB13 Novartis Consumer Health<br />

SA, Nyon,<br />

12. 1. 2003 SINEPRES DRAZˇEJI dihidroergotoksin 50 tablet C02LA51 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Hrvaška v sodelovanju<br />

s SmithKline Beecham<br />

Phar.<br />

Hrvaška v sodelovanju<br />

s SmithKline Beecham<br />

Phar.<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Nemčija<br />

Nemčija<br />

d.d., Ljubljana Slovenija<br />

Velika Britanija za<br />

Abbott Laboratories<br />

S.A., Baar<br />

Švica<br />

Švica<br />

Švica<br />

d.d., Ljubljana Slovenija<br />

1590 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 5. 2004 SINGULAIR 10 mg montelukast zlozˇenka z 28 tabletami (4 × 7 tablet ali<br />

2 × 14 tablet v pretisnem omotu)<br />

7. 5. 2004 SINGULAIR 5 mg montelukast zlozˇenka z 28 tabletami (4 × 7 tablet ali<br />

2 × 14 tablet v pretisnem omotu)<br />

4. 1. 2004 SINVACOR simvastatin škatla z 20 tabletami po 10 mg (2 × 10<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 SINVACOR simvastatin škatla z 20 tabletami po 20 mg (2 × 10<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 SINVACOR simvastatin škatla z 28 tabletami po 40 mg (2 × 14<br />

tablet v pretisnem omotu)<br />

24. 6. 2004 SINVACOR 80 mg simvastatin zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

R03DC03 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

R03DC03 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

C10AA01 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

C10AA01 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

C10AA01 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

C10AA01 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

9. 4. 2004 SKINOREN krema azelainska kislina zlozˇenka s tubo po 30 g kreme D10AX03 Schering S.p.A., Milano,<br />

Italija za Schering AG,<br />

20. 9. 2004 SOLU-CORTEF 100 mg hidrokortizon zlozˇenka z 1 dvodelno vialo (Act-O-vial)<br />

po 100 mg hidrokortizona in 2 ml<br />

vehikla za pripravo raztopine<br />

20. 9. 2004 SOLU-CORTEF 500 mg hidrokortizon zlozˇenka z 1 dvodelno vialo (Act-O-vial)<br />

po 500 mg hidrokortizona in 4 ml<br />

vehikla za pripravo raztopine<br />

19. 3. 2004 SOLU-MEDROL 1000 mg metilprednizolon zlozˇenka z 1 vialo s praškom in 1vialo<br />

topila<br />

19. 3. 2004 SOLU-MEDROL 125 mg metilprednizolon zlozˇenka z 1 dvodelno vialo (Act-O-vial)<br />

s praškom in 2 ml topila za pripravo<br />

raztopine<br />

19. 3. 2004 SOLU-MEDROL 40 mg metilprednizolon zlozˇenka z 1 dvodelno vialo (Act-O-vial)<br />

s praškom in 1 ml topila za pripravo<br />

raztopine<br />

19. 3. 2004 SOLU-MEDROL 500 mg metilprednizolon zlozˇenka z 1 vialo s praškom in 1 vialo<br />

topila<br />

9. 4. 2004 SOLUDEKS 1 dekstran zlozˇenka z 10 prebodnimi stekleničkami<br />

po 20 ml raztopine<br />

9. 4. 2004 SOLUDEKS 40 dekstran zlozˇenka z 10 prebodnimi steklenicami<br />

po 500 ml raztopine<br />

H02AB09 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

H02AB09 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

H02AB04 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

H02AB04 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

H02AB04 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

H02AB04 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

Berlin, Nemčija<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

B05AA05 Pliva d.d., Zagreb Hrvaška<br />

B05AA05 Pliva d.d., Zagreb Hrvaška<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1591


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

9. 4. 2004 SOLUDEKS 70 dekstran zlozˇenka z 10 prebodnimi steklenicami<br />

po 500 ml raztopine<br />

28. 6. 2001 SOLUTIO ANTICOAGULANS<br />

(ACD), sestava B<br />

28. 6. 2001 SOLUTIO ANTICOAGULANS<br />

(ACD), sestava B<br />

28. 6. 2001 SOLUTIO ANTICOAGULANS<br />

COMPOSITA-CPD<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

B05AA05 Pliva d.d., Zagreb Hrvaška<br />

steklenica po 500 ml raztopine V07AC Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

steklenica po 250 ml raztopine V07AC Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

steklenička po 100 ml raztopine V07AC Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

12. 4. 2001 SOLUTIO KALII CHLORIDI 1 M kalijev klorid steklenička po 100 ml raztopine B05XA01 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

12. 4. 2001 SOLUTIO NATRII CHLORIDI<br />

10 %<br />

12. 4. 2001 SOLUTIO NATRII CHLORIDI<br />

0,45 %<br />

28. 9. 2005 SOLUTIO NATRII CHLORIDI<br />

0,9%<br />

natrijev klorid steklenička po 100 ml raztopine B05BB01 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

natrijev klorid steklenica po 500 ml raztopine B05BB01 Zavod Republike Slovenije<br />

za transfuzijo krvi<br />

natrijev klorid zlozˇenka s kapalno plastenko po 20 ml<br />

raztopine<br />

R01AX10 Zavod Republike Slovenije<br />

za transfuzijo krvi,<br />

24. 6. 2004 SOLUTIO NATRII CHLORIDI 1M natrijev klorid steklenička po 100 ml raztopine B05XA03 Zavod Republike Slovenije<br />

za transfuzijo krvi,<br />

24. 6. 2004 SOLVOLAN ambroksol zlozˇenka s stekleničko po 100 ml sirupa<br />

(15 mg/5 ml)<br />

24. 6. 2004 SOLVOLAN ambroksol zlozˇenka z 20 tabletami po 30 mg<br />

(2 × 10 tablet v pretisnem omotu)<br />

R05CB06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

R05CB06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

22. 6. 2005 SOREL mazilo 0,005% kalcipotriol zlozˇenka s tubo po 30 g mazila D05AX02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

22. 6. 2005 SOREL mazilo 0,005% kalcipotriol zlozˇenka s tubo po 100 g mazila D05AX02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

22. 6. 2005 SOREL raztopina 0,005% kalcipotriol zlozˇenka s plastenko po 60 ml raztopine D05AX02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 6. 2005 SORTIS 10 mg atorvastatin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

2. 6. 2005 SORTIS 10 mg atorvastatin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

2. 6. 2005 SORTIS 10 mg atorvastatin zlozˇenka s 100 tabletami (10 × 10 tablet<br />

v pretisnem omotu)<br />

2. 6. 2005 SORTIS 20 mg atorvastatin zlozˇenka s 100 tabletami (10 × 10 tablet<br />

v pretisnem omotu)<br />

C10AA05 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

C10AA05 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

C10AA05 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

C10AA05 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

Farmacevtski oddelek-<br />

Pharmagena, Ljubljana<br />

Farmacevtski oddelek-<br />

Pharmagena, Ljubljana<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

GmbH Berlin, Freiburg Nemčija<br />

GmbH Berlin, Freiburg Nemčija<br />

GmbH Berlin, Freiburg Nemčija<br />

GmbH Berlin, Freiburg Nemčija<br />

1592 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

2. 6. 2005 SORTIS 20 mg atorvastatin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

2. 6. 2005 SORTIS 20 mg atorvastatin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

2. 6. 2005 SORTIS 40 mg atorvastatin zlozˇenka z 28 tabletami (1 × 28 tablet v<br />

pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

C10AA05 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

C10AA05 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

C10AA05 Gödecke AG, Freiburg,<br />

Nemčija za Parke-Davis<br />

9. 7. 2003 SPASMEX forte tablete 5 mg trospij 20 × 5 mg A03AB20 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 SPASMEX injekcije 0,2 mg/5 ml trospij 10 ampul po 5 ml (0,2 mg/5 ml) A03AB20 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

9. 7. 2003 SPASMEX injekcije 0,2 mg/5 ml trospij 50 ampul po 5 ml (0,2 mg/5 ml) A03AB20 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

28. 6. 2001 SPERSADEX COMP. deksametazon plastenka po 5 ml raztopine S01CA01 Ciba Vision Dispersa Ltd.,<br />

Hettlingen<br />

30. 5. 2002 SPERSALLERG kapljice za oči antazolin zlozˇenka s plastenko po 10 ml raztopine S01GA52 Ciba Vision Dispersa Ltd.,<br />

Hettlingen<br />

7. 5. 2004 SPORANOX itrakonazol zlozˇenka s 4 kapsulami po 100 mg (1 ×<br />

4 kapsule v pretisnem omotu)<br />

7. 5. 2004 SPORANOX itrakonazol zlozˇenka s 15 kapsulami po 100 mg (1 ×<br />

15 kapsul v pretisnem omotu)<br />

J02AC02 Janssen Pharmaceutica N.V.,<br />

Beerse,<br />

J02AC02 Janssen Pharmaceutica N.V.,<br />

Beerse,<br />

12. 1. 2003 STEDIRIL norgestrel 21 tablet G03AA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

12. 1. 2003 STEDIRIL — D etinilestradiol 21 tablet G03AA07 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

12. 1. 2003 STEDIRIL — M etinilestradiol 21 tablet G03AA07 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

2. 4. 2003 STIMOKAL tablete 10 mg nikorandil 30 × 10 mg C01DX16 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 STIMOKAL tablete 10 mg nikorandil 60 × 10 mg C01DX16 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 STIMOKAL tablete 20 mg nikorandil 30 × 20 mg C01DX16 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 STIMOKAL tablete 20 mg nikorandil 60 × 20 mg C01DX16 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

3. 7. 2003 STREPTAZA 1.500.000 streptokinaza zlozˇenka z eno vialo s praškom B01AD01 Hoechst Marion Roussel<br />

Deutchland GmbH, Marburg,<br />

3. 7. 2003 STREPTAZA 250.000 streptokinaza zlozˇenka z eno vialo s praškom B01AD01 Hoechst Marion Roussel<br />

Deutchland GmbH, Marburg,<br />

GmbH Berlin, Freiburg Nemčija<br />

GmbH Berlin, Freiburg Nemčija<br />

GmbH Berlin, Freiburg Nemčija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

sodelovanju z Wyeth,<br />

Nemčija<br />

sodelovanju z Wyeth,<br />

Nemčija<br />

sodelovanju z Wyeth,<br />

Nemčija<br />

Švica<br />

Švica<br />

Belgija<br />

Belgija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Nemčija za H.M.R.<br />

Deutchland GmbH,<br />

Frankfurt<br />

Nemčija za H.M.R.<br />

Deutchland GmbH,<br />

Frankfurt<br />

Nemčija<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1593


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

3. 7. 2003 STREPTAZA 750.000 streptokinaza zlozˇenka z eno vialo s praškom B01AD01 Hoechst Marion Roussel<br />

Deutchland GmbH, Marburg,<br />

7. 3. 2002 STREPTOKINASE Braun<br />

1,500.000<br />

streptokinaza 1 steklenička<br />

po1,500.000 I.E.streptokinaze<br />

B01AD01 B. Braun Melsungen AG,<br />

Melsungen<br />

7. 3. 2002 STREPTOKINASE Braun 100.000 streptokinaza 1 steklenička po 100.000 I.E. B01AD01 B. Braun Melsungen AG,<br />

Melsungen<br />

7. 3. 2002 STREPTOKINASE Braun 250.000 streptokinaza 1 steklenička po 250.000 I.E. B01AD01 B. Braun Melsungen AG,<br />

Melsungen<br />

7. 3. 2002 STREPTOKINASE Braun 750.000 streptokinaza 1 steklenička po 750.000 I.E. B01AD01 B. Braun Melsungen AG,<br />

Melsungen<br />

3. 11. 2003 STUGERON FORTE cinarizin 50 × 75 mg N07CA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

19. 3. 2004 SUFENTA sufentanil zlozˇenka s 5 ampulami po 2 ml raztopine<br />

(0,005 mg/ml)<br />

19. 3. 2004 SUFENTA FORTE sufentanil zlozˇenka s 5 ampulami po 5 ml raztopine<br />

(0,05 mg/ml)<br />

12. 7. 2004 SULFASALAZIN sulfasalazin<br />

(salazosulfapiridin)<br />

2. 4. 2003 SULFASALAZIN EN sulfasalazin<br />

(salazosulfapiridin)<br />

zlozˇenka s 50 tabletami po 500 mg (5 ×<br />

10 tablet v pretisnem omotu)<br />

zlozˇenka s 50 tabletami po 500 mg (5 ×<br />

10 tablet v pretisnem omotu)<br />

19. 3. 2004 SULPIRID kapsule 200 mg sulpirid zlozˇenka s plastičnim vsebnikom po<br />

12 kapsul<br />

19. 3. 2004 SULPIRID kapsule 50 mg sulpirid zlozˇenka s 30 kapsulami (2 × 15 kapsul v<br />

pretisnem omotu)<br />

N01AH03 Janssen Pharmaceutica N.V.,<br />

Beerse,<br />

N01AH03 Janssen Pharmaceutica N.V.,<br />

Beerse,<br />

A07EC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

A07EC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

N05AL01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

N05AL01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

Nemčija za H.M.R.<br />

Deutchland GmbH,<br />

Frankfurt<br />

sodelovanju z Janssen<br />

Pharmaceutica, Belgija<br />

20. 12. 2001 SUMAMED S tablete azitromicin 2 tableti po 500 mg J01FA10 Pliva d.d., Zagreb Hrvaška<br />

30. 5. 2002 SUMAMED SIRUP 1200 azitromicin steklenička s praškom za pripravo 30 ml<br />

suspenzije , merilno brizgo in merilno<br />

zˇličko<br />

2. 4. 2003 SUPREFACT DEPOT buserelin napolnjena injekcija z dvema enakima<br />

vstavkoma v obliki paličice (2 × 3 mg)<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Belgija<br />

Belgija<br />

Slovenija<br />

Slovenija<br />

Hrvaška<br />

Hrvaška<br />

J01FA10 Pliva d.d., Zagreb Hrvaška<br />

L02AE01 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

Frankfurt,<br />

Nemčija / Hoechst<br />

Marion Roussel GmbH,<br />

Dunaj<br />

Avstrija<br />

1594 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

4. 1. 2004 SUSTAC FORTE gliceriltrinitrat škatla s plastenko po 25 tablet<br />

(25 × 6,4 mg)<br />

4. 1. 2004 SUSTAC MITE gliceriltrinitrat škatla s plastenko po 25 tablet<br />

(25 × 2,6 mg)<br />

7. 3. 2002 SYNALAR gel fluocinolonacetonid<br />

7. 3. 2002 SYNALAR krema fluocinolonacetonid<br />

7. 3. 2002 SYNALAR mazilo fluocinolonacetonid<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

C01DA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

C01DA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

zlozˇenka s tubo po 30 g gela D07AC04 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

zlozˇenka s tubo po 15 g kreme D07AC04 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

zlozˇenka s tubo po 15 g mazila D07AC04 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

sodelovanju s Streuli &<br />

Co. AG, Uznach, Švica<br />

sodelovanju s Streuli &<br />

Co. AG, Uznach, Švica<br />

1. 7. 2004 SYNOPEN mazilo kloropiramin zlozˇenka s tubo po 20 g mazila D04AA09 Pliva d.d., Zagreb Hrvaška<br />

30. 5. 2002 TACHOCOMB hemostatiki za<br />

lokalno<br />

zdravljenje<br />

30. 5. 2002 TACHOCOMB hemostatiki za<br />

lokalno<br />

zdravljenje<br />

30. 5. 2002 TACHOCOMB hemostatiki za<br />

lokalno<br />

zdravljenje<br />

30. 5. 2002 TACHOCOMB hemostatiki za<br />

lokalno<br />

zdravljenje<br />

30. 5. 2002 TACHOCOMB hemostatiki za<br />

lokalno<br />

zdravljenje<br />

30. 5. 2002 TACHOCOMB hemostatiki za<br />

lokalno<br />

zdravljenje<br />

5 krpic dimenzije 9,5cm × 4,8cm ×<br />

0,5cm<br />

1 krpica dimenzije 2,5cm × 3,0cm ×<br />

0,5cm<br />

10 krpic dimenzije 9,5cm × 4,8cm ×<br />

0,5cm<br />

10 krpic dimenzije 2,5cm × 3,0cm ×<br />

0,5cm<br />

5 krpic dimenzije 2,5cm × 3,0cm ×<br />

0,5cm<br />

1 krpica dimenzije 9,5cm × 4,8cm ×<br />

0,5cm<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

B02BC NYCOMED Austria GmbH Avstrija<br />

B02BC NYCOMED Austria GmbH Avstrija<br />

B02BC NYCOMED Austria GmbH Avstrija<br />

B02BC NYCOMED Austria GmbH Avstrija<br />

B02BC NYCOMED Austria GmbH Avstrija<br />

B02BC NYCOMED Austria GmbH Avstrija<br />

9. 7. 2003 TADOL tramadol 5 ampul po 2 ml (100 mg/2 ml) N02AX02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 TADOL tramadol 20 × 50 mg N02AX02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 TADOL tramadol 5 ampul po 1 ml (50 mg/ml) N02AX02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 TADOL tramadol 5 × 100 mg N02AX02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 TADOL tramadol steklenička po 10 ml (100 mg/ml) N02AX02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

2. 4. 2003 TADOL RETARD tramadol 30 × 100 mg N02AX02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1595


Datum<br />

veljavnosti<br />

Ime zdravila<br />

12. 1. 2003 TAFEN NASAL, pršilo za<br />

nos 50 µg<br />

mednarodno<br />

nelastniško ime<br />

budezonid steklenička po 10 ml suspenzije (za 200<br />

vpihov -50 µg/ vpih)<br />

28. 6. 2001 TAFEN aerosol 200 µg budezonid inhalator za 200 inhalacij<br />

(200 µg/inhalacijo)<br />

12. 1. 2003 TAFEN aerosol 50 µg budezonid vdihovalnik po 10 ml suspenzije (za 200<br />

inhalacij -50 µg/inhalacijo)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

R01AD05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

R03BA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

R03BA02 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

7. 3. 2002 TAGREN tiklopidin 30 × 250mg B01AC05 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

12. 9. 2005 TALIDAT 500 mg hidrotalcit zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

19. 3. 2004 TAMETIL domperidon zlozˇenka s stekleničko po 30 tablet<br />

(30 × 10 mg)<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Slovenija<br />

A02AD04 MERCK KGaA, Darmstadt, Nemčija<br />

A03FA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

7. 3. 2002 TAMICIN injekcije 1 g cefpiramid 10 stekleničk po 1 g J01DA27 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

19. 3. 2004 TARACEF cefaklor zlozˇenka s stekleničko z zrnci za pripravo<br />

60 ml suspenzije (125 mg/5 ml)<br />

19. 3. 2004 TARACEF cefaklor zlozˇenka s stekleničko z zrnci za pripravo<br />

60 ml suspenzije (250 mg/5 ml)<br />

28. 6. 2001 TARACEF cefaklor zlozˇenka s 16 kapsulami po 500 mg<br />

(2 × 8 kapsul v pretisnem omotu)<br />

28. 6. 2001 TARACEF cefaklor zlozˇenka s 16 kapsulami po 250 mg<br />

(2 × 8 kapsul v pretisnem omotu)<br />

28. 6. 2001 TARACEF peroralna suspenzija<br />

125mg/5ml<br />

cefaklor zlozˇenka s stekleničko s praškom za<br />

pripravo 60 ml suspenzije (125mg/5ml)<br />

2. 6. 2005 TARACEF 2× cefaklor zlozˇenka z 10 tabletami po 500 mg<br />

(1 × 10 tablet v pretisnem omotu)<br />

19. 3. 2004 TARACEF 2× cefaklor zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

2. 6. 2005 TARACEF 2× cefaklor zlozˇenka z 10 tabletami po 750 mg<br />

(1 × 10 tablet v pretisnem omotu)<br />

28. 6. 2001 TARACEF peroralna suspenzija<br />

250mg/5ml<br />

cefaklor zlozˇenka s stekleničko s praškom za<br />

pripravo 60 ml suspenzije (250mg/5ml)<br />

J01DA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01DA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01DA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01DA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01DA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01DA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01DA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01DA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J01DA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

3. 11. 2003 TARIVID ofloksacin 10 × 200 mg J01MA01 Hoechst Marion Roussel AG,<br />

Frankfurt<br />

3. 11. 2003 TARIVID 400 ofloksacin 10 × 400 mg J01MA01 Hoechst Marion Roussel AG,<br />

Frankfurt<br />

3. 11. 2003 TARIVID i.v. 200 ofloksacin steklenička po 100 ml (200 mg/100 ml) J01MA01 Hoechst Marion Roussel AG,<br />

Frankfurt<br />

sodelovanju z Janssen<br />

Pharmaceutica, Belgija<br />

d.d., Ljubljana Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

1596 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

3. 11. 2003 TARIVID i.v. 400 ofloksacin steklenička po 200 ml (400 mg/200 ml) J01MA01 Hoechst Marion Roussel AG,<br />

Frankfurt<br />

11. 2. 2003 TARKA trandolapril 28 kapsul C09BB10 Knoll AG, Ludwigshafen, Nemčija<br />

10. 11. 2002 TASMAR tolkapon 100 × 100 mg N04BX01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

10. 11. 2002 TASMAR tolkapon 100 × 200 mg N04BX01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

22. 6. 2005 TAVANIC filmsko oblozˇene<br />

tablete 250 mg<br />

22. 6. 2005 TAVANIC filmsko oblozˇene<br />

tablete 500 mg<br />

22. 6. 2005 TAVANIC raztopina za<br />

intravensko infundiranje 5 mg/ml<br />

levofloksacin zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

levofloksacin zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

levofloksacin zlozˇenka s stekleničko po 100 ml<br />

raztopine<br />

7. 7. 2002 TAXOL paklitaksel zlozˇenka z 1 vialo po 5 ml koncentrata<br />

(30 mg/5 ml)<br />

7. 7. 2002 TAXOL paklitaksel škatla z 10 zlozˇenkami z 1 vialo po 5 ml<br />

koncentrata (30 mg/5 ml)<br />

7. 7. 2002 TAXOL paklitaksel zlozˇenka z 1 vialo po 16,7 ml<br />

koncentrata (100 mg/16,7ml)<br />

10. 11. 2002 TAXOTERE 20 mg docetaksel injekcijska steklenička po 0,5 ml<br />

koncentrata (20 mg/0,5 ml) in injekcijska<br />

steklenička po 1,5 ml topila<br />

10. 11. 2002 TAXOTERE 80 mg docetaksel injekcijska steklenička po 2 ml<br />

koncentrata (80 mg/2 ml) in injekcijska<br />

steklenička po 6 ml topila<br />

2. 6. 2005 TAZOCIN 2,25 g injekcija za<br />

intravensko uporabo<br />

2. 6. 2005 TAZOCIN 4,5 g injekcija za<br />

intravensko uporabo<br />

12. 1. 2003 Td cepivo — ADSORBIRANO<br />

CEPIVO PROTI TETANUSU IN<br />

DAVICI ZA ODRASLE IN<br />

MLADINO<br />

J01MA12 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

Frankfurt,<br />

J01MA12 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

Frankfurt,<br />

J01MA12 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

Frankfurt,<br />

L01CD01 Bristol-Myers Squibb S.p.A.,<br />

Sermoneta (Latina),<br />

L01CD01 Bristol-Myers Squibb S.p.A.,<br />

Sermoneta (Latina),<br />

L01CD01 Bristol-Myers Squibb S.p.A.,<br />

Sermoneta (Latina),<br />

L01CD02 Rhone Poulenc Rorer<br />

Pharma Specialites<br />

L01CD02 Rhone Poulenc Rorer<br />

Pharma Specialites<br />

piperacilin zlozˇenka z eno vialo s praškom J01CR05 Wyeth Laboratories, Havant,<br />

Velika Britanija za<br />

piperacilin zlozˇenka z eno vialo s praškom J01CR05 Wyeth Laboratories, Havant,<br />

Velika Britanija za<br />

davični anatoksin<br />

(toksoid)<br />

v naprej napolnjena brizga po 0,5 ml J07AM51 Chiron Behring GmbH &<br />

Co., Marburg<br />

Nemčija / Hoechst<br />

Marion Roussel GmbH,<br />

Dunaj<br />

Nemčija / Hoechst<br />

Marion Roussel GmbH,<br />

Dunaj<br />

Nemčija / Hoechst<br />

Marion Roussel GmbH,<br />

Dunaj<br />

Italija za Bristol-Myers<br />

Squibb Products S.A.,<br />

Baar<br />

Italija za Bristol-Myers<br />

Squibb Products S.A.,<br />

Baar<br />

Italija za Bristol-Myers<br />

Squibb Products S.A.,<br />

Baar<br />

American Cyanamid<br />

Company,Cyanamid<br />

Int.Corp.Lim.<br />

American Cyanamid<br />

Company,Cyanamid<br />

Int.Corp.Lim.<br />

Nemčija<br />

Švica<br />

Švica<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Švica<br />

Švica<br />

Švica<br />

Francija<br />

Francija<br />

ZDA<br />

ZDA<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1597


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 12. 2003 TEARS NATURALE II dekstran zlozˇenka s plastenko (z zaporko s<br />

kapalko) po 15 ml raztopine<br />

9. 4. 2004 TEGRETOL karbamazepin zlozˇenka s 50 tabletami (5 × 10 tablet v<br />

pretisnem omotu)<br />

17. 12. 2004 TEGRETOL CR karbamazepin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

S01XA20 Alcon Laboratories, Inc.<br />

ZDA, za Alcon<br />

Pharmaceuticals Ltd.,<br />

Cham, Švica<br />

N03AF01 Pliva d.d., Zagreb Hrvaška<br />

N03AF01 Pliva d.d., Zagreb Hrvaška<br />

3. 11. 2003 TELFAST 120 feksofenadin 30 × 120 mg R06AX26 Hoechst Marion Roussel Inc.,<br />

ZDA, za Hoechst<br />

3. 11. 2003 TELFAST 180 feksofenadin 30 × 180 mg R06AX26 Hoechst Marion Roussel Inc.,<br />

ZDA, za Hoechst<br />

7. 3. 2002 TENORMIN atenolol 14 × 100 mg C07AB03 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

9. 7. 2003 TENZIMET pindolol 20 tablet C07CA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

24. 6. 2004 TENZIPIN RETARD isradipin zlozˇenka z 20 kapsulami po 5 mg<br />

(2 × 10 kapsul v pretisnem omotu)<br />

C08CA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

2. 4. 2003 TEOLIN retard tablete 125 mg teofilin 40 × 125 mg R03DA04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

2. 4. 2003 TEOLIN retard tablete 300 mg teofilin 40 × 300 mg R03DA04 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

19. 3. 2004 TEOTARD 200 teofilin zlozˇenka s 40 kapsulami (4 × 10 kapsul v<br />

pretisnem omotu)<br />

19. 3. 2004 TEOTARD 350 teofilin zlozˇenka s 40 kapsulami (4 × 10 kapsul v<br />

pretisnem omotu)<br />

1. 10. 2004 TERIDIN peroralna suspenzija<br />

30 mg/5 ml<br />

terfenadin zlozˇenka s stekleničko po 100 ml<br />

suspenzije in merilno zˇličko<br />

1. 10. 2004 TERIDIN tablete 60 mg terfenadin zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

29. 11. 2004 TERTENSIF SR indapamid zlozˇenka s 30 tabletami po 1,5 mg<br />

(2 × 15 tablet v pretisnem omotu)<br />

27. 5. 2004 TERUFLEX BB AGT 356 I (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

zlozˇenka s 4 trojnimi vrečkami s CPD in<br />

SAGM za 350 ml krvi v plastičnem<br />

vsebniku, zaprtem s prozorno folijo<br />

(primarna vrečka -350 ml in 2 satelitski<br />

vrečki -300 ml)<br />

R03DA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

R03DA04 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

R06AX12 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

R06AX12 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

C03BA11 Les Laboratoires Servier<br />

Industrie, Gidy,<br />

V07AC Terumo Corporation,<br />

Hatagaya, Shibuja-ku, Tokyo<br />

Marion Roussel GmbH,<br />

Dunaj, Avstrija<br />

Marion Roussel GmbH,<br />

Dunaj, Avstrija<br />

sodelovanju z Novartis<br />

Pharma Ltd., Švica<br />

sodelovanju z Novartis<br />

Pharma Ltd., Švica<br />

Velika<br />

Britanija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

sodelovanju s Klinge<br />

Pharma GmbH,<br />

München<br />

sodelovanju s Klinge<br />

Pharma GmbH,<br />

München<br />

Nemčija<br />

Nemčija<br />

Slovenija<br />

Slovenija<br />

Francija<br />

Japonska<br />

1598 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

27. 5. 2004 TERUFLEX BB AGT 456 E (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

27. 5. 2004 TERUFLEX BB DCD 356 E (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

27. 5. 2004 TERUFLEX BB DCD 456 E (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

27. 5. 2004 TERUFLEX BB SCD 356 E (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

27. 5. 2004 TERUFLEX BB SCD 456 E (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

27. 5. 2004 TERUFLEX BB TCD 456 E (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

30. 5. 2002 TETABULIN Inject tetanusni<br />

antitoksin<br />

2. 4. 2003 TETAGAM P humani<br />

imunoglobulin<br />

proti<br />

tetanusnemu<br />

toksinu<br />

12. 1. 2003 TETANOL tetanusni<br />

anatoksin<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

zlozˇenka s 4 trojnimi vrečkami s CPD in<br />

SAGM za 450 ml krvi v plastičnem<br />

vsebniku, zaprtem s prozorno folijo<br />

(primarna vrečka -450 ml in 2 satelitski<br />

vrečki -400 ml)<br />

zlozˇenka s 5 dvojnini vrečkami s CPDA-1<br />

za 350 ml krvi v plastičnem vsebniku,<br />

zaprtem s prozorno folijo (primarna<br />

vrečka - 350 ml in satelitska vrečka<br />

300 ml)<br />

zlozˇenka s 5 dvojnimi vrečkami s<br />

CPDA-1 za 450 ml krvi v plastičnem<br />

vsebniku, zaprtem s prozorno folijo<br />

(primarna vrečka-450 ml in satelitska<br />

vrečka-400 ml)<br />

zlozˇenka z 10 enojnimi vrečkami s<br />

CPDA-1 za 350 ml krvi v plastičnem<br />

vsebniku, zaprtem s prozorno folijo<br />

zlozˇenka z 10 enojnimi vrečkami s<br />

CPDA-1 za 450 ml krvi v plastičnem<br />

vsebniku, zaprtem s prozorno folijo<br />

zlozˇenka s 4 trojnimi vrečkami s CPDA-1<br />

za 450 ml krvi v plastičnem vsebniku,<br />

zaprtem s prozorno folijo (primarna<br />

vrečka-450 ml in 2 satelitski vrečki<br />

- 400 ml)<br />

1 napolnjena injekcijska brizga po 1 ml<br />

raztopine (250 I.E./1ml)<br />

20. 9. 2004 TIFOL folna kislina zlozˇenka s 30 tabletami po 0,4 mg<br />

(2 × 15 tablet v pretisnem omotu)<br />

20. 9. 2004 TIFOL folna kislina zlozˇenka s 60 tabletami po 0,4 mg<br />

(4 × 15 tablet v pretisnem omotu)<br />

7. 7. 2002 TIMOPTIC XE timolol zlozˇenka s plastenko po 2,5 ml raztopine<br />

(5 mg/ml)<br />

V07AC Terumo Corporation,<br />

Hatagaya, Shibuja-ku, Tokyo<br />

V07AC Terumo Corporation,<br />

Hatagaya, Shibuja-ku, Tokyo<br />

V07AC Terumo Corporation,<br />

Hatagaya, Shibuja-ku, Tokyo<br />

V07AC Terumo Corporation,<br />

Hatagaya, Shibuja-ku, Tokyo<br />

V07AC Terumo Corporation,<br />

Hatagaya, Shibuja-ku, Tokyo<br />

V07AC Terumo Corporation,<br />

Hatagaya, Shibuja-ku, Tokyo<br />

ampula po 1 ml (250 I.E./ml) J06BB02 Centeon Pharma GmbH,<br />

Marburg<br />

v naprej napolnjena brizga po 0,5 ml J07AM01 Chiron Behring GmbH &<br />

Co., Marburg<br />

Japonska<br />

Japonska<br />

Japonska<br />

Japonska<br />

Japonska<br />

Japonska<br />

J06AA02 Immuno AG, Dunaj, Avstrija<br />

B03BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

B03BB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

S01ED01 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

Nemčija<br />

Nemčija<br />

Slovenija<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1599


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

7. 7. 2002 TIMOPTIC XE timolol zlozˇenka s plastenko po 2,5 ml raztopine<br />

(2,5 mg/ml)<br />

25. 2. 2005 TISSUCOL KIT (tkivni adhezivi) zlozˇenka z eno vialo praška s<br />

koagulacijskimi proteini in 1 vialo<br />

raztopine aprotinina (za pripravo 1 ml<br />

raztopine) ter 1 vialo po 4 I.E.trombina, 1<br />

vialo po 500 I.E. trombina in 1 vialo z<br />

raztopino kalcijevega klorida (za pripravo<br />

1 ml raztopine); pribo<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

S01ED01 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

V03AK Österreichisches Institut für<br />

Haemoderivate Ges.<br />

12. 7. 2004 TOBRADEX mazilo za oko deksametazon zlozˇenka s tubo po 3,5 g mazila S01CA01 S.A. Alcon-Couvreur N.V.,<br />

Puurs, Belgija za Alcon<br />

12. 7. 2004 TOBRADEX kapljice za oko deksametazon zlozˇenka s kapalno plastenko po 5 ml<br />

suspenzije<br />

S01CA01 S.A. Alcon-Couvreur N.V.,<br />

Puurs, Belgija za Alcon<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

m.b.H., Production<br />

Division of IMMUNO<br />

AG Dunaj<br />

Pharmaceuticals Ltd.,<br />

Hünenberg, Švica<br />

Pharmaceuticals Ltd.,<br />

Hünenberg, Švica<br />

11. 2. 2003 TOCLASE drazˇeji 25 mg pentoksiverin 20 × 25 mg R05DB05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

11. 2. 2003 TOCLASE sirup 12,5 mg/5 ml pentoksiverin steklenička po 120 g (12,5 mg/5 ml) R05DB05 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

30. 5. 2002 TOLVON tablete 30 mg mianserin 20 × 30mg N06AX03 N. V. Organon, Oss, Nizozemska<br />

30. 5. 2002 TOPAMAX topiramat 60 × 100 mg N03AX11 Cilag AG, Schaffhausen, Švica<br />

30. 5. 2002 TOPAMAX topiramat 60 × 25 mg N03AX11 Cilag AG, Schaffhausen, Švica<br />

30. 5. 2002 TOPAMAX topiramat 60 × 50 mg N03AX11 Cilag AG, Schaffhausen, Švica<br />

30. 5. 2002 TOPAMAX topiramat 60 × 300 mg N03AX11 Cilag AG, Schaffhausen, Švica<br />

30. 5. 2002 TOPAMAX topiramat 60 × 400 mg N03AX11 Cilag AG, Schaffhausen, Švica<br />

30. 5. 2002 TOPAMAX topiramat 60 × 200 mg N03AX11 Cilag AG, Schaffhausen, Švica<br />

12. 1. 2003 TORECAN tietilperazin 6 × 6,5 mg R06AD03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

12. 1. 2003 TORECAN tietilperazin 50 × 6,5 mg R06AD03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

12. 1. 2003 TORECAN tietilperazin 50 ampul po 1 ml (6,5 mg/ ml) R06AD03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

12. 11. 2004 TRACRIUM 25 mg atrakurij zlozˇenka s 5 ampulami po 2,5 ml<br />

raztopine<br />

M03AC04 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

12. 11. 2004 TRACRIUM 50 mg atrakurij zlozˇenka s 5 ampulami po 5 ml raztopine M03AC04 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

29. 11. 2004 TRAMAL tramadol zlozˇenka s 30 tabletami po 50 mg<br />

(3 × 10 tablet v pretisnem omotu)<br />

N02AX02 Bayer Pharma d.o.o.,<br />

Ljubljana, po licenci<br />

sodelovanju z Novartis<br />

Pharma Ltd., Švica<br />

sodelovanju z Novartis<br />

Pharma Ltd., Švica<br />

sodelovanju z Novartis<br />

Pharma Ltd., Švica<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Grünenthal GmbH,<br />

Nemčija<br />

Avstrija<br />

1600 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

29. 11. 2004 TRAMAL tramadol zlozˇenka z 10 tabletami po 50 mg<br />

(1 × 10 tablet v pretisnem omotu)<br />

20. 12. 2001 TRAMAL raztopina tramadol steklenička po 10ml raztopine<br />

(100mg/1ml)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

N02AX02 Bayer Pharma d.o.o.,<br />

Ljubljana, po licenci<br />

Grünenthal GmbH,<br />

Nemčija<br />

N02AX02 Bayer Pharma d.o.o. Slovenija<br />

20. 12. 2001 TRAMAL 100 tramadol 5 ampul po 2 ml raztopine (100mg/2ml) N02AX02 Bayer Pharma d.o.o. Slovenija<br />

20. 12. 2001 TRAMAL 50 tramadol 5 ampul po 1 ml raztopine (50mg/1ml) N02AX02 Bayer Pharma d.o.o. Slovenija<br />

20. 12. 2001 TRAMAL kapsule tramadol 20 × 50 mg N02AX02 Bayer Pharma d.o.o. Slovenija<br />

20. 12. 2001 TRAMAL raztopina tramadol steklenička po 96 ml raztopine<br />

(100mg/1ml)<br />

N02AX02 Bayer Pharma d.o.o. Slovenija<br />

2. 4. 2003 TRAMAL retard 150 mg tramadol 30 × 150 mg N02AX02 Bayer Pharma d.o.o.,<br />

Grünenthal GmbH,<br />

Ljubljana, po licenci<br />

Nemčija<br />

2. 4. 2003 TRAMAL retard 200 mg tramadol 30 × 200 mg N02AX02 Bayer Pharma d.o.o.,<br />

Grünenthal GmbH,<br />

Ljubljana, po licenci<br />

Nemčija<br />

20. 12. 2001 TRAMAL svečke tramadol 5 × 100 mg N02AX02 Bayer Pharma d.o.o. Slovenija<br />

18. 1. 2005 TRAMUNDIN RETARD tramadol zlozˇenka s 50 tabletami (5 × 10 tablet v N02AX02 Mundipharma GmbH,<br />

Medical Company,<br />

pretisnem omotu)<br />

Limburg, Nemčija za<br />

Mundipharma<br />

Hamilton, Bermuda<br />

9. 7. 2003 TRASYLOL 500 000 KIE aprotinin steklenička po 50 ml (500 000<br />

B02AB01 Bayer Pharma d.o.o.,<br />

v sodelovanju z Bayer<br />

KIE/50 ml)<br />

Ljubljana, Slovenija<br />

AG, Nemčija<br />

23. 10. 2003 TRENTAL pentoksifilin zlozˇenka s 25 ampulami po 5 ml<br />

C04AD03 Hoechst Marion Roussel Nemčija / Hoechst Avstrija<br />

raztopine<br />

Deutschland GmbH,<br />

Marion Roussel GmbH,<br />

Frankfurt,<br />

Dunaj<br />

23. 10. 2003 TRENTAL pentoksifilin zlozˇenka s 5 ampulami po 5 ml raztopine C04AD03 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

Frankfurt,<br />

23. 10. 2003 TRENTAL pentoksifilin zlozˇenka z 10 ampulami po 15 ml<br />

raztopine<br />

20. 9. 2004 TRENTAL 400 pentoksifilin zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

24. 6. 2004 TRI-STEDIRIL levonorgestrel zlozˇenka z 21 tabletami v pretisnem<br />

omotu (6 rjavih, 5 belih in 10 rumenih<br />

tablet)<br />

C04AD03 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

Frankfurt,<br />

C04AD03 Hoechst Marion Roussel<br />

GmbH, Dunaj<br />

G03AB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

Nemčija / Hoechst<br />

Marion Roussel GmbH,<br />

Dunaj<br />

Nemčija / Hoechst<br />

Marion Roussel GmbH,<br />

Dunaj<br />

sodelovanju z Wyeth-<br />

Lederle Pharma GmbH,<br />

Dunaj<br />

30. 5. 2002 TRIANOL afriški pigej 30 × 25 mg G04CX01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

30. 5. 2002 TRIANOL afriški pigej 100 × 25 mg G04CX01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

23. 10. 2003 TRINOVUM noretisteron zlozˇenka z 21 tabletami (1 × 21 tablet v<br />

pretisnem omotu — 7 belih, 7 roza in 7<br />

oranzˇnih tablet)<br />

G03AB04 Cilag AG, Schaffhausen, Švica<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1601


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

7. 3. 2002 TRISEQUENS estradiol 28 tablet (12 modrih, 10 belih, 6 rdečih) G03FB05 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

Danska<br />

7. 3. 2002 TRISEQUENS FORTE estradiol 28 tablet (12 rumenih, 10 belih, 6 rdečih) G03FB05 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

Danska<br />

30. 5. 2002 TRUSOPT dorzolamid kapalna plastenka po 5 ml (20mg/1ml) S01EC03 MERCK SHARP & DOHME-<br />

CHIBRET A.G.,<br />

Francija Francija<br />

30. 5. 2002 TVINDAL cefuroksim 5 vial po 750 mg J01DA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

30. 5. 2002 TVINDAL cefuroksim 1 viala po 1500 mg J01DA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

30. 5. 2002 TVINDAL cefuroksim 5 vial po 1500 mg J01DA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

30. 5. 2002 TVINDAL cefuroksim 5 vial po 1500 mg J01DA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

30. 5. 2002 TVINDAL cefuroksim 1 viala po 1500 mg J01DA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

30. 5. 2002 TVINDAL cefuroksim 1 viala po 750 mg J01DA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

30. 5. 2002 TVINDAL cefuroksim 1 viala po 250 mg J01DA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

30. 5. 2002 TVINDAL cefuroksim 5 vial po 250 mg J01DA06 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

7. 7. 2002 UBRETID injekcije 0,5 mg distigmin zlozˇenka s 5 × 5 ampulami po 1 ml<br />

raztopine (0,5mg/1ml)<br />

N07AA03 NYCOMED Austria GmbH Avstrija<br />

7. 7. 2002 UBRETID injekcije 0,5 mg distigmin zlozˇenka s 5 ampulami po 1 ml raztopine<br />

(0,5mg/1ml)<br />

N07AA03 NYCOMED Austria GmbH Avstrija<br />

7. 7. 2002 UBRETID injekcije 0,5 mg distigmin zlozˇenka s 3 ampulami po 1 ml raztopine<br />

(0,5mg/1ml)<br />

N07AA03 NYCOMED Austria GmbH Avstrija<br />

7. 7. 2002 UBRETID tablete 5 mg distigmin 50 × 5 mg N07AA03 NYCOMED Austria GmbH Avstrija<br />

7. 7. 2002 UBRETID tablete 5 mg distigmin 20 × 5 mg N07AA03 NYCOMED Austria GmbH Avstrija<br />

19. 3. 2004 ULFAMID famotidin zlozˇenka z 20 tabletami po 20 mg<br />

(2 × 10 tablet v pretisnem omotu)<br />

19. 3. 2004 ULFAMID famotidin zlozˇenka s 100 tabletami po 20 mg<br />

(10 × 10 tablet v pretisnem omotu)<br />

19. 3. 2004 ULFAMID famotidin zlozˇenka z 10 tabletami po 40 mg<br />

(1 × 10 tablet v pretisnem omotu)<br />

19. 3. 2004 ULFAMID famotidin zlozˇenka s 100 tabletami po 40 mg<br />

(10 × 10 tablet v pretisnem omotu)<br />

A02BA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

A02BA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

A02BA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

A02BA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

1602 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

19. 3. 2004 ULFAMID famotidin zlozˇenka z 10 tabletami po 20 mg<br />

(1 × 10 tablet v pretisnem omotu)<br />

1. 7. 2004 ULRAN filmsko oblozˇene tablete<br />

150 mg<br />

1. 7. 2004 ULRAN filmsko oblozˇene tablete<br />

300 mg<br />

ranitidin zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

ranitidin zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

A02BA03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

A02BA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

A02BA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

9. 7. 2003 ULTIVA injekcije 1 mg remifentanil 5 vial po 1 mg N01AH06 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

9. 7. 2003 ULTIVA injekcije 2 mg remifentanil 5 vial po 2 mg N01AH06 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

9. 7. 2003 ULTIVA injekcije 5 mg remifentanil 5 vial po 5 mg N01AH06 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

28. 6. 2001 ULTOP omeprazol 14 × 20 mg A02BC01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

15. 1. 2004 ULTRACAIN D-S injekcije<br />

1:200.000<br />

15. 1. 2004 ULTRACAIN D-S injekcije<br />

1:200.000<br />

12. 4. 2001 ULTRACORTENOL kapljice za<br />

oko<br />

12. 4. 2001 ULTRACORTENOL mazilo za<br />

oko<br />

artikain zlozˇenka s 100 vlozˇki po 1,7 ml<br />

raztopine (10 × 10 vlozˇkov v pretisnem<br />

omotu)<br />

artikain zlozˇenka s 100 ampulami po 2 ml<br />

raztopine<br />

prednizolon kapalna plastenka po 5 ml raztopine<br />

(5mg/1ml)<br />

N01BB58 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

N01BB58 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

S01BA04 Ciba Vision Dispersa Ltd.,<br />

Hettlingen<br />

prednizolon tubo po 5 g mazila za oko (5mg/1g) S01BA04 Ciba Vision Dispersa Ltd.,<br />

Hettlingen<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Frankfurt am Main Nemčija<br />

Frankfurt am Main Nemčija<br />

24. 12. 2004 ULTRALAN ORAL-20 fluokortolon zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

H02AB03 Schering AG, Berlin, Nemčija<br />

24. 12. 2004 ULTRALAN ORAL-5 fluokortolon zlozˇenka z 20 tabletami (1 × 20 tablet v<br />

pretisnem omotu)<br />

H02AB03 Schering AG, Berlin, Nemčija<br />

25. 2. 2005 ULTRAPROCT mazilo fluokortolon zlozˇenka s tubo po 30 g mazila C05AA08 Schering AG, Berlin, Nemčija<br />

25. 2. 2005 ULTRAPROCT svečke fluokortolon zlozˇenka z 10 svečkami v dvojnem traku C05AA08 Schering AG, Berlin, Nemčija<br />

20. 9. 2004 ULTRAVIST 300 jopromid zlozˇenka z 10 vialami po 10 ml<br />

raztopine<br />

V08AB05 Schering AG, Berlin, Nemčija<br />

20. 9. 2004 ULTRAVIST 300 jopromid zlozˇenka z 10 vialami po 20 ml<br />

raztopine<br />

V08AB05 Schering AG, Berlin, Nemčija<br />

20. 9. 2004 ULTRAVIST 300 jopromid zlozˇenka z 10 vialami po 50 ml<br />

raztopine<br />

V08AB05 Schering AG, Berlin, Nemčija<br />

20. 9. 2004 ULTRAVIST 370 jopromid zlozˇenka z 10 vialami po 50 ml<br />

raztopine<br />

V08AB05 Schering AG, Berlin, Nemčija<br />

Švica<br />

Švica<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1603


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

20. 9. 2004 ULTRAVIST 370 jopromid zlozˇenka z 10 vialami po 30 ml<br />

raztopine<br />

V08AB05 Schering AG, Berlin, Nemčija<br />

20. 9. 2004 ULTRAVIST 370 jopromid zlozˇenka z 10 vialami po 100 ml<br />

raztopine<br />

V08AB05 Schering AG, Berlin, Nemčija<br />

20. 9. 2004 ULTRAVIST 370 jopromid zlozˇenka z 10 vialami po 200 ml<br />

raztopine<br />

V08AB05 Schering AG, Berlin, Nemčija<br />

12. 4. 2001 UNIPRES 10 nitrendipin 20 × 10mg C08CA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

12. 4. 2001 UNIPRES 20 nitrendipin 20 × 20mg C08CA08 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

Slovenija<br />

23. 10. 2003 URBASON 8 metilprednizolon zlozˇenka s 30 tabletami (3 × 10 tablet v<br />

pretisnem omotu)<br />

24. 12. 2004 UROGRAFIN 76% diatrizojska<br />

kislina<br />

28. 6. 2001 UROMITEXAN raztopina za<br />

injiciranje 400 mg/4 ml<br />

zlozˇenka z 10 ampulami po 20 ml<br />

raztopine<br />

mesna zlozˇenka s 15 ampulami po 4 ml<br />

raztopine<br />

29. 11. 2004 UROMITEXAN tablete 400 mg mesna zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

29. 11. 2004 UROMITEXAN tablete 600 mg mesna zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

9. 4. 2004 URUTAL 8 mg tablete betahistin zlozˇenka s steklenim vsebnikom po 100<br />

tablet<br />

H02AB04 Hoechst Marion Roussel<br />

Deutschland GmbH,<br />

Frankfurt am Main Nemčija<br />

V08AA01 Schering AG, Berlin, Nemčija<br />

V03AF01 Asta Medica AG, Frankfurt<br />

am Main<br />

V03AF01 Temmler Pharma GmbH,<br />

Marburg, Nemčija za Asta<br />

V03AF01 Temmler Pharma GmbH,<br />

Marburg, Nemčija za Asta<br />

N07CA01 Belupo, zdravila in<br />

kozmetika, d.o.o.,<br />

Koprivnica,<br />

28. 6. 2001 VAGIFEM vaginalete estradiol 15 vaginalnih tablet in 15 aplikatorjev G03CA03 Novo Nordisk A/S,<br />

Bagsvaerd,<br />

15. 2. 2004 VALTREX valaciklovir zlozˇenka z 42 tabletami po 500 mg<br />

(7 × 6 tablet v pretisnem omotu)<br />

15. 2. 2004 VALTREX valaciklovir zlozˇenka z 10 tabletami po 500 mg<br />

(1 × 10 tablet v pretisnem omotu)<br />

15. 2. 2005 VAMIN 14 EF aminokisline zlozˇenka s steklenico po 500 ml<br />

raztopine<br />

15. 2. 2005 VAMIN 18 EF aminokisline zlozˇenka s steklenico po 500 ml<br />

raztopine<br />

15. 2. 2005 VAMINOLACT aminokisline zlozˇenka s stekleničko po 100 ml<br />

raztopine<br />

J05AB11 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

J05AB11 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

B05BA01 Fresenius Kabi France S.A.,<br />

Francija za Fresenius<br />

B05BA01 Fresenius Kabi France S.A.,<br />

Francija za Fresenius<br />

B05BA01 Fresenius Kabi France S.A.,<br />

Francija za Fresenius<br />

Medica AG, Dresden,<br />

Nemčija<br />

Medica AG, Dresden,<br />

Nemčija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Kabi AB,Švedska/<br />

Fresenius Kabi<br />

Deutschland Gmbh<br />

Kabi AB,Švedska/<br />

Fresenius Kabi<br />

Deutschland Gmbh<br />

Kabi AB, Švedska/<br />

Fresenius Kabi<br />

Deutschland Gmbh<br />

Nemčija<br />

Hrvaška<br />

Danska<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

1604 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

15. 2. 2005 VAMINOLACT aminokisline zlozˇenka s steklenico po 500 ml<br />

raztopine<br />

4. 1. 2004 VAQTA prečiščen antigen<br />

virusa hepatitisa<br />

tipa A<br />

4. 1. 2004 VAQTA prečiščen antigen<br />

virusa hepatitisa<br />

tipa A<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

škatla z vialo po 0,5 ml suspenzije<br />

(25 E/0,5 ml)<br />

škatla z vialo po 1 ml suspenzije<br />

(50 E/ml)<br />

4. 1. 2004 VASILIP simvastatin škatla z 20 tabletami po 10 mg (2 × 10<br />

tablet v pretisnem omotu)<br />

4. 1. 2004 VASILIP simvastatin škatla z 20 tabletami po 20 mg (2 × 10<br />

tablet v pretisnem omotu)<br />

30. 5. 2002 VAXIGRIP 96/97 prečiščen antigen<br />

virusa influence<br />

napolnjena injekcijska brizga po 0,5 ml<br />

suspenzije (za en odmerek)<br />

B05BA01 Fresenius Kabi France S.A.,<br />

Francija za Fresenius<br />

J07BC02 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

J07BC02 MERCK SHARP & DOHME<br />

BV Nizozemska za<br />

C10AA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

C10AA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

J07BB02 Pasteur Merieux Serums &<br />

Vaccins, Lyon<br />

Kabi AB,Švedska/<br />

Fresenius Kabi<br />

Deutschland Gmbh<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

MERCK SHARP &<br />

DOHME IDEA, INC.,<br />

Švica<br />

28. 6. 2001 VELBE vinblastin steklenička po 10 mg in topilo L01CA01 Lilly France S.A., Fegersheim Francija<br />

7. 3. 2002 VELORIN atenolol 30 × 100 mg C07AB03 Remedica Ltd., Limassol Ciper<br />

7. 3. 2002 VELORIN atenolol 14 × 100 mg C07AB03 Remedica Ltd., Limassol Ciper<br />

7. 5. 2004 VENIMMUN N humani<br />

zlozˇenka z eno vialo po 8,4 g praška in J06BA02 Centeon Pharma GmbH, Centeon Pharma<br />

imunoglobulini eno vialo po 100 ml vode za injekcije,<br />

Marburg, Nemčija za<br />

GmbH, Dunaj, Avstrija<br />

za<br />

intravaskularno<br />

aplikacijo<br />

pretočnim in infuzijskim sistemom<br />

7. 5. 2004 VENIMMUN N humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

7. 5. 2004 VENIMMUN N humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

7. 5. 2004 VENIMMUN N humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

zlozˇenka z eno vialo po 840 mg praška<br />

in eno ampulo po 10 ml vode za injekcije<br />

zlozˇenka z eno vialo po 4,2 g praška in<br />

eno vialo po 50 ml vode za injekcije,<br />

pretočnim in infuzijskim sistemom<br />

zlozˇenka z eno vialo po 17 g praška in<br />

eno vialo po 200 ml vode za injekcije,<br />

pretočnim in infuzijskim sistemom<br />

24. 6. 2004 VENITAN FORTE gel heparin zlozˇenka s tubo po 50 g gela (100 I.E.<br />

natrijevega heparinata + 10 mg escina/g )<br />

2. 4. 2003 VENOFER injekcije 100 mg/5ml zˇelezov(III) oksid<br />

saharat<br />

J06BA02 Centeon Pharma GmbH,<br />

Marburg, Nemčija za<br />

J06BA02 Centeon Pharma GmbH,<br />

Marburg, Nemčija za<br />

J06BA02 Centeon Pharma GmbH,<br />

Marburg, Nemčija za<br />

C05BA53 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

5 ampul po 5 ml (100 mg/ 5ml) B03AC02 LEK, d.d., Ljubljana, v<br />

sodelovanju z Vifor<br />

Centeon Pharma<br />

GmbH, Dunaj, Avstrija<br />

Centeon Pharma<br />

GmbH, Dunaj, Avstrija<br />

Centeon Pharma<br />

GmbH, Dunaj, Avstrija<br />

Nemčija<br />

Slovenija<br />

Slovenija<br />

Francija<br />

d.d., Ljubljana Slovenija<br />

(International) Inc., St.<br />

Gallen, Švica<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1605


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

28. 6. 2001 VENORUTON rutozid tuba po 40 g gela (2g/100g) C05CA04 ZYMA S.A., Nyon, Švica<br />

28. 6. 2001 VENORUTON rutozid tuba po 100 g gela (2g/100g) C05CA04 ZYMA S.A., Nyon, Švica<br />

28. 6. 2001 VENORUTON 300 rutozid 20 × 300 mg C05CA04 ZYMA S.A., Nyon, Švica<br />

19. 3. 2004 VENTER sukralfat<br />

zlozˇenka s 50 tabletami po 1 g (5 × 10 A02BX02 KRKA, tovarna zdravil, d.d.,<br />

Slovenija<br />

(aluminijev<br />

saharozni sulfat)<br />

tablet v pretisnem omotu)<br />

Novo mesto,<br />

19. 3. 2004 VENTER sukralfat<br />

(aluminijev<br />

saharozni sulfat)<br />

zlozˇenka s 50 vrečkami po 2 g zrnc<br />

(1 g/2 g)<br />

12. 4. 2001 VENTODISKS salbutamol 15 diskusov po 8 blistrov po 200 µg<br />

salbutamola in Diskhaler<br />

21. 5. 2004 VENTOLIN pršilnik salbutamol zlozˇenka s kovinskim vsebnikom (z<br />

odmernim ventilom) s suspenzijo pod<br />

tlakom za 200 odmerkov in ustnikom<br />

21. 5. 2004 VENTOLIN raztopina za<br />

inhaliranje<br />

salbutamol zlozˇenka s stekleničko po 20 ml<br />

raztopine<br />

A02BX02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

R03AC02 Glaxo Group Ltd.,<br />

Laboratoires Glaxo, Evreux,<br />

R03AC02 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

R03AC02 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

21. 5. 2004 VENTOLIN sirup salbutamol zlozˇenka s stekleničko po 150 ml sirupa R03CC02 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

21. 5. 2004 VENTOLIN tablete salbutamol zlozˇenka s plastenko po 100 tablet R03CC02 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

19. 3. 2004 VERMOX mebendazol zlozˇenka s steklenim vsebnikom po<br />

30 ml suspenzije (100 mg/5 ml) in<br />

plastično merilno zˇličko<br />

19. 3. 2004 VERMOX mebendazol zlozˇenka s 6 tabletami v dvojnem traku<br />

(6 × 100 mg)<br />

4. 1. 2004 VIAGRA 100 mg sildenafil škatla s 4 tabletami po 100 mg v<br />

pretisnem omotu<br />

4. 1. 2004 VIAGRA 25 mg sildenafil škatla s 4 tabletami po 25 mg v<br />

pretisnem omotu<br />

4. 1. 2004 VIAGRA 50 mg sildenafil škatla s 4 tabletami po 50 mg v<br />

pretisnem omotu<br />

P02CA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

P02CA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto, v<br />

G04BE03 Pfizer S.A., Francija, za Pfizer<br />

International<br />

G04BE03 Pfizer S.A., Francija, za Pfizer<br />

International<br />

G04BE03 Pfizer S.A., Francija, za Pfizer<br />

International<br />

24. 6. 2005 VIBRAMYCIN kapsule 100 mg doksiciklin zlozˇenka s stekleničko po 5 kapsul J01AA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

24. 6. 2005 VIBRAMYCIN kapsule 100 mg doksiciklin zlozˇenka s stekleničko po 100 kapsul J01AA02 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto v<br />

29. 11. 2004 VIOXX 25 mg rofekoksib zlozˇenka z 28 tabletami (4 × 7 tablet v<br />

pretisnem omotu)<br />

M01AH02 MSD Pty Ltd., Avstralija ali<br />

MSD B.V., Nizozemska<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

sodelovanju z Janssen<br />

Pharmaceutica, Belgija<br />

sodelovanju z Janssen<br />

Pharmaceutica, Belgija<br />

Inc., New York, ZDA<br />

Inc., New York, ZDA<br />

Inc., New York, ZDA<br />

sodelovanju s Pfizer<br />

Inc., New York, ZDA<br />

sodelovanju s Pfizer<br />

Inc., New York, ZDA<br />

za MERCK SHARP &<br />

DOHME IDEA INC.,<br />

Švica<br />

Slovenija<br />

Francija<br />

1606 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

29. 11. 2004 VIOXX 25 mg/5 ml rofekoksib zlozˇenka s steklenim vsebnikom po<br />

150 ml suspenzije in merilno zˇličko<br />

29. 11. 2004 VIOXX 12,5 mg rofekoksib zlozˇenka z 28 tabletami (4 × 7 tablet v<br />

pretisnem omotu)<br />

29. 11. 2004 VIOXX 12,5 mg/5 ml rofekoksib zlozˇenka s steklenim vsebnikom po<br />

150 ml suspenzije in merilno zˇličko<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

M01AH02 MERCK & CO., INC., MMD,<br />

West Point, PA, ZDA ali<br />

M01AH02 MSD Pty Ltd., Avstralija ali<br />

MSD B.V., Nizozemska<br />

M01AH02 MERCK & CO., INC., MMD,<br />

West Point, PA, ZDA ali<br />

19. 3. 2004 VIROLEX aciklovir zlozˇenka s tubo po 2 g kreme (50 mg/g) D06BB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto iz aktivne<br />

19. 3. 2004 VIROLEX aciklovir zlozˇenka s tubo po 5 g kreme (50 mg/g) D06BB03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto iz aktivne<br />

19. 3. 2004 VIROLEX aciklovir zlozˇenka z 20 tabletami po 200 mg<br />

(2 × 10 tablet v pretisnem omotu)<br />

19. 3. 2004 VIROLEX aciklovir zlozˇenka s 5 vialami s praškom za<br />

pripravo raztopine (250 mg/vialo)<br />

19. 3. 2004 VIROLEX aciklovir zlozˇenka s tubo po 4,5 g mazila<br />

(30 mg/g)<br />

24. 6. 2004 VISINE tetrizolin zlozˇenka s plastičnim vsebnikom (s<br />

kapalnim nastavkom) po 15 ml raztopine<br />

(0,5 mg/ml)<br />

24. 6. 2004 VISINE A. C. tetrizolin zlozˇenka s plastičnim vsebnikom (s<br />

kapalnim nastavkom) po 15 ml raztopine<br />

(0,5 mg tetrizolinijevega klorida + 2,5 mg<br />

cinkovega sulfata/ml)<br />

15. 2. 2005 VITALIPID N ADULT vitamini zlozˇenka z 10 ampulami po 10 ml<br />

koncentrata<br />

15. 2. 2005 VITALIPID N INFANT vitamini zlozˇenka z 10 ampulami po 10 ml<br />

koncentrata<br />

J05AB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto iz aktivne<br />

J05AB01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto iz aktivne<br />

S01AD03 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto iz aktivne<br />

S01GA02 Pfizer Canada Inc., Kanada,<br />

za Pfizer<br />

S01GA52 Pfizer Canada Inc., Kanada,<br />

za Pfizer<br />

B05XC Fresenius Kabi AB,<br />

Stockholm za Fresenius Kabi<br />

AB<br />

B05XC Fresenius Kabi AB,<br />

Stockholm za Fresenius Kabi<br />

AB<br />

11. 2. 2003 VITAMIN B 12 cianokobalamin 100 ampul po 1 ml (500 µg/ml) B03BA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

11. 2. 2003 VITAMIN B 12 cianokobalamin 100 ampul po 1 ml (100 µg/ml) B03BA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

MSD B.V., Nizozemska<br />

za MSD IDEA INC.,<br />

Švica<br />

za MERCK SHARP &<br />

DOHME IDEA INC.,<br />

Švica<br />

MSD B.V., Nizozemska<br />

za MSD IDEA INC.,<br />

Švica<br />

substance firme The<br />

Wellcome Foundation<br />

Limited<br />

substance firme The<br />

Wellcome Foundation<br />

Limited<br />

substance firme The<br />

Wellcome Foundation<br />

Limited<br />

substance firme The<br />

Wellcome Foundation<br />

Limited<br />

substance firme The<br />

Wellcome Foundation<br />

Limited<br />

International Inc., New<br />

York, ZDA<br />

International Inc., New<br />

York, ZDA<br />

Uppsala, Švedska/<br />

Fresenius Kabi<br />

Deutschland Gmbh<br />

Uppsala, Švedska/<br />

Fresenius Kabi<br />

Deutschland Gmbh<br />

Nemčija<br />

Nemčija<br />

Slovenija<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1607


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

28. 6. 2001 VITAMIN C oblozˇene tablete askorbinska<br />

kislina<br />

(vitamin C)<br />

28. 6. 2001 VITAMIN C zrnca askorbinska<br />

kislina<br />

(vitamin C)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

30 × 350 mg A11GA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

steklenička po 100 g zrnc (500mg/5g) A11GA01 KRKA, tovarna zdravil, d.d.,<br />

Novo mesto,<br />

28. 6. 2001 VITREOLENT kalijev jodid plastenka po 10 ml raztopine S01XA04 Ciba Vision Dispersa Ltd.,<br />

Hettlingen<br />

2. 4. 2003 VOBENOL tablete 100 µg natrijev<br />

levotiroksinat<br />

50 × 100 µg H03AA01 LEK, tovarna farmacevtskih<br />

in kemičnih izdelkov,<br />

Slovenija<br />

Slovenija<br />

Švica<br />

d.d., Ljubljana Slovenija<br />

1. 7. 2004 VOLTAREN FORTE tablete diklofenak zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

M01AB05 Pliva d.d., Zagreb Hrvaška<br />

9. 4. 2004 VOLTAREN gel diklofenak zlozˇenka s tubo po 60 g gela M02AA15 Pliva d.d., Zagreb Hrvaška<br />

1. 7. 2004 VOLTAREN injekcije diklofenak zlozˇenka s 5 ampulami po 3 ml raztopine M01AB05 Pliva d.d., Zagreb Hrvaška<br />

9. 4. 2004 VOLTAREN RAPID diklofenak zlozˇenka z 10 tabletami (1 × 10 tablet v<br />

pretisnem omotu)<br />

M01AB05 Pliva d.d., Zagreb Hrvaška<br />

1. 7. 2004 VOLTAREN RETARD tablete diklofenak zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

M01AB05 Pliva d.d., Zagreb Hrvaška<br />

1. 7. 2004 VOLTAREN svečke 12,5 mg diklofenak zlozˇenka z 10 svečkami (2 × 5 svečk v<br />

dvojnem traku)<br />

M01AB05 Pliva d.d., Zagreb Hrvaška<br />

1. 7. 2004 VOLTAREN svečke 25 mg diklofenak zlozˇenka z 10 svečkami (2 × 5 svečk v<br />

dvojnem traku)<br />

M01AB05 Pliva d.d., Zagreb Hrvaška<br />

1. 7. 2004 VOLTAREN svečke 50 mg diklofenak zlozˇenka z 10 svečkami (2 × 5 svečk v<br />

dvojnem traku)<br />

M01AB05 Pliva d.d., Zagreb Hrvaška<br />

20. 12. 2001 WARTEC — WOLFF podofilotoksin steklenička po 3 ml raztopine (5mg/1ml)<br />

in plastični vsebnik z nanašalniki<br />

28. 6. 2001 X-PREP senini glikozidi steklenička po 75 ml raztopine<br />

(150mg/75ml)<br />

3. 11. 2003 XALATAN latanoprost zlozˇenka s kapalno plastenko po 2,5 ml<br />

raztopine (50 µg/ml)<br />

3. 11. 2003 XALATAN latanoprost zlozˇenka s 3 kapalnimi plastenkami po<br />

2,5 ml raztopine (50 µg/ml)<br />

D06BB04 Dr. August Wolff & Co.,<br />

Arzneimittel, Bielefeld<br />

A06AB06 Mundipharma GmbH,<br />

Limburg<br />

S01EX03 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

S01EX03 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

7. 3. 2002 XANAX 0,25 mg alprazolam zlozˇenka s 30 tabletami N05BA12 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

7. 3. 2002 XANAX 0,5mg alprazolam zlozˇenka s 30 tabletami N05BA12 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Nemčija<br />

Nemčija<br />

1608 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

7. 3. 2002 XANAX 1mg alprazolam zlozˇenka s 30 tabletami N05BA12 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

7. 3. 2002 XANAX SR 0,5 mg alprazolam zlozˇenka s 30 tabletami N05BA12 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

7. 3. 2002 XANAX SR 1 mg alprazolam zlozˇenka s 30 tabletami N05BA12 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

7. 3. 2002 XANAX SR 2 mg alprazolam zlozˇenka s 30 tabletami N05BA12 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

7. 3. 2002 XANAX SR 3 mg alprazolam zlozˇenka s 30 tabletami N05BA12 Pharmacia & Upjohn<br />

N.V./S.A., Puurs, Belgija<br />

29. 11. 2004 XENETIX 250 jobitridol zlozˇenka s stekleničko po 50 ml<br />

raztopine<br />

29. 11. 2004 XENETIX 300 jobitridol zlozˇenka s stekleničko po 50 ml<br />

raztopine<br />

29. 11. 2004 XENETIX 300 jobitridol zlozˇenka s stekleničko po 100 ml<br />

raztopine<br />

29. 11. 2004 XENETIX 350 jobitridol zlozˇenka s stekleničko po 50 ml<br />

raztopine<br />

29. 11. 2004 XENETIX 350 jobitridol zlozˇenka s stekleničko po 100 ml<br />

raztopine<br />

24. 6. 2004 XENICAL trde kapsule 120 mg orlistat zlozˇenka z 42 kapsulami (2 × 21 kapsul<br />

v pretisnem omotu)<br />

24. 6. 2004 XENICAL trde kapsule 120 mg orlistat zlozˇenka s 84 kapsulami (4 × 21 kapsul v<br />

pretisnem omotu)<br />

12. 11. 2004 XYLONOR SPRAY lidokain zlozˇenka s stekleničko (z odmerno<br />

črpalko) s 36 g raztopine<br />

V08AB11 Laboratoire Guerbet, Aulnaysous-Bois<br />

V08AB11 Laboratoire Guerbet, Aulnaysous-Bois<br />

V08AB11 Laboratoire Guerbet, Aulnaysous-Bois<br />

V08AB11 Laboratoire Guerbet, Aulnaysous-Bois<br />

V08AB11 Laboratoire Guerbet, Aulnaysous-Bois<br />

A08AB01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

A08AB01 F. Hoffmann-La Roche Ltd.,<br />

Basel<br />

N01BB02 Specialites Septodont, Saint<br />

Maur des Fosses<br />

3. 11. 2003 ZANTAC 75 tablete ranitidin 12 × 75 mg A02BA02 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

3. 7. 2003 ZAVEDOS 10 mg idarubicin zlozˇenka z 1 vialo s praškom L01DB06 Pharmacia & Upjohn S.p.A.,<br />

Nerviano, Italija za<br />

3. 7. 2003 ZAVEDOS 5 mg idarubicin zlozˇenka z 1 vialo s praškom L01DB06 Pharmacia & Upjohn S.p.A.,<br />

Nerviano, Italija za<br />

4. 1. 2004 ZERIT 15 mg, kapsule stavudin zlozˇenka s 56 kapsulami (4 × 14 kapsul v<br />

pretisnem omotu)<br />

J05AF04 Bristol-Myers Squibb, Champ<br />

‘Lachaud’- La<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Francija<br />

Francija<br />

Francija<br />

Francija<br />

Francija<br />

Švica<br />

Švica<br />

Cedex Francija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Pharmacio & Upjohn<br />

S.A., Luxemburg<br />

Pharmacio & Upjohn<br />

S.A., Luxemburg<br />

Goualle, Meymac Francija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1609


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

4. 1. 2004 ZERIT 20 mg, kapsule stavudin zlozˇenka s 56 kapsulami (4 × 14 kapsul v<br />

pretisnem omotu)<br />

4. 1. 2004 ZERIT 30 mg, kapsule stavudin zlozˇenka s 56 kapsulami (4 × 14 kapsul v<br />

pretisnem omotu)<br />

4. 1. 2004 ZERIT 40 mg, kapsule stavudin zlozˇenka s 56 kapsulami (4 × 14 kapsul v<br />

pretisnem omotu)<br />

4. 1. 2004 ZERIT, prašek za peroralno<br />

raztopino<br />

stavudin zlozˇenka s stekleničko s praškom za<br />

pripravo 200 ml raztopine in plastičnim<br />

merilnim lončkom<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

J05AF04 Bristol-Myers Squibb, Champ<br />

‘Lachaud’- La<br />

J05AF04 Bristol-Myers Squibb, Champ<br />

‘Lachaud’- La<br />

J05AF04 Bristol-Myers Squibb, Champ<br />

‘Lachaud’- La<br />

J05AF04 Bristol-Myers Squibb, Champ<br />

‘Lachaud’- La<br />

8. 5. 2003 ZINACEF injekcije 1,5 g cefuroksim zlozˇenka z eno vialo s praškom J01DA06 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

8. 5. 2003 ZINACEF injekcije 750 mg cefuroksim zlozˇenka z eno vialo s praškom J01DA06 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

15. 2. 2005 ZINACEF MONOVIALA 1,5 g cefuroksim zlozˇenka z eno vialo s praškom (viala z<br />

zaporko z injekcijsko iglo)<br />

15. 2. 2005 ZINACEF MONOVIALA 750 mg cefuroksim zlozˇenka z eno vialo s praškom (viala z<br />

zaporko z injekcijsko iglo)<br />

9. 7. 2003 ZINNAT prašek za peroralno<br />

suspenzijo 125 mg/5 ml<br />

cefuroksim steklenička po 50 g praška za pripravo<br />

50 ml suspenzije (125 mg/5 ml)<br />

J01DA06 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

J01DA06 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

J01DA06 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

9. 7. 2003 ZINNAT tablete 125 mg cefuroksim 10 × 125 mg J01DA06 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

9. 7. 2003 ZINNAT tablete 250 mg cefuroksim 10 × 250 mg J01DA06 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

9. 7. 2003 ZINNAT tablete 500 mg cefuroksim 10 × 500 mg J01DA06 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

29. 11. 2004 ZINNAT zrnca za peroralno<br />

suspenzijo 250 mg/5 ml<br />

cefuroksim zlozˇenka s stekleničko (z za otroke varno<br />

zaporko) z zrnci za pripravo 100 ml<br />

suspenzije in merilno brizgo za peroralno<br />

dajanje<br />

J01DA06 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

9. 7. 2003 ZOFRAN injekcije 4 mg ondansetron 5 ampul po 2 ml (4 mg/2 ml) A04AA01 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

9. 7. 2003 ZOFRAN injekcije 8 mg ondansetron 5 ampul po 4 ml (8 mg/4 ml) A04AA01 Glaxo Wellcome S.p.A.,<br />

Italija za Glaxo Wellcome<br />

9. 7. 2003 ZOFRAN tablete 4 mg ondansetron 10 × 4 mg A04AA01 Glaxo Wellcome S.A.,<br />

Aranda de Duero, Španija, za<br />

9. 7. 2003 ZOFRAN tablete 8 mg ondansetron 10 × 8 mg A04AA01 Glaxo Wellcome S.A.,<br />

Aranda de Duero, Španija, za<br />

Goualle, Meymac Francija<br />

Goualle, Meymac Francija<br />

Goualle, Meymac Francija<br />

Goualle, Meymac Francija<br />

Export Ltd., Velika<br />

Britanija<br />

Export Ltd., Velika<br />

Britanija<br />

Export Ltd., Velika<br />

Britanija<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Export Ltd., Velika<br />

Britanija<br />

Export Ltd., Velika<br />

Britanija<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Export Ltd., Velika<br />

Britanija<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

1610 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Datum<br />

veljavnosti<br />

Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

29. 11. 2004 ZOLADEX LA 10,8 mg goserelin zlozˇenka z injekcijsko brizgo z enim<br />

implantatom<br />

12. 11. 2004 ZOLOFT 100 mg sertralin zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

12. 11. 2004 ZOLOFT 50 mg sertralin zlozˇenka z 28 tabletami (2 × 14 tablet v<br />

pretisnem omotu)<br />

7. 12. 2003 ZOMIG zolmitriptan škatla s 3 tabletami v pretisnem omotu (3<br />

× 2,5 mg)<br />

7. 12. 2003 ZOMIG zolmitriptan škatla s 6 tabletami v pretisnem omotu (6<br />

× 5 mg)<br />

7. 12. 2003 ZOMIG zolmitriptan škatla s 6 tabletami v pretisnem omotu (6<br />

× 2,5 mg)<br />

7. 12. 2003 ZOMIG zolmitriptan škatla s 3 tabletami v pretisnem omotu (3<br />

× 5 mg)<br />

4. 1. 2004 ZYLORIC alopurinol škatla s stekleničko po 100 tablet (100 ×<br />

100 mg)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

L02AE03 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

N06AB06 Pfizer Italiana S.p.A. Latina,<br />

Italija za Pfizer<br />

N06AB06 Pfizer Italiana S.p.A. Latina,<br />

Italija za Pfizer<br />

N02CC03 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

N02CC03 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

N02CC03 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

N02CC03 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

M04AA01 Glaxo Wellcome Operations,<br />

Velika Britanija, za<br />

30. 5. 2002 ZYPREXA olanzapin 56 × 10 mg N05AH03 Eli Lilly and Company<br />

Limited, Basingstoke<br />

30. 5. 2002 ZYPREXA olanzapin 28 × 10 mg N05AH03 Eli Lilly and Company<br />

Limited, Basingstoke<br />

30. 5. 2002 ZYPREXA olanzapin 28 × 5 mg N05AH03 Eli Lilly and Company<br />

Limited, Basingstoke<br />

International<br />

Corporation, New<br />

York, ZDA<br />

International<br />

Corporation, New<br />

York, ZDA<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1611


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

List 2: Data on the Renewals of Marketing Authorisations under the Renewal Procedure<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

5-FU fluorouracil steklenička 1×1000mg/20ml L01BC02 Cyanamid International Corporation<br />

Limited,<br />

5-FU fluorouracil steklenička 1×250mg/5ml L01BC02 Cyanamid International Corporation<br />

Limited,<br />

5-FU fluorouracil steklenizka 1×500mg/10ml L01BC02 Cyanamid International Corporation<br />

Limited,<br />

ACLOVIR tablete 400 mg aciklovir 25 × 400 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR injekcije 1000 mg aciklovir 10 injekcijskih stekleničk po 1000 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR injekcije 1000 mg aciklovir 5 injekcijskih steklenizk po 1000 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR injekcije 250 mg aciklovir 10 injekcijskih steklenizk po 250 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR injekcije 250 mg aciklovir 5 injekcijskih steklenizk po 250 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR injekcije 500 mg aciklovir 10 injekcijskih steklenizk po 500 mg in 10<br />

ampul po 10 ml vode<br />

ACLOVIR injekcije 500 mg aciklovir 5 injekcijskih steklenizk po 500 mg in 5<br />

ampul po 10 ml vode<br />

ACLOVIR injekcije 500 mg aciklovir 10 injekcijskih steklenizk po 500 mg in 10<br />

ampul po 20 ml vode<br />

ACLOVIR injekcije 500 mg aciklovir 5 injekcijskih steklenizk po 500 mg in 5<br />

ampul po 20 ml vode<br />

J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR kapsule 200 mg aciklovir 25 × 200 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR kapsule 200 mg aciklovir 100 × 200 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR krema 5% aciklovir tuba po 10 g (50mg/1g) D06BB03 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR krema 5% aciklovir tuba po 5 g (50mg/1g) D06BB03 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR krema 5% aciklovir tuba po 2 g (50mg/1g) D06BB03 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR tablete 200 mg aciklovir 100 × 200 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR tablete 200 mg aciklovir 25 × 200 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

1612 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

ACLOVIR tablete 400 mg aciklovir 100 × 400 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR tablete 800 mg aciklovir 100 × 800 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ACLOVIR tablete 800 mg aciklovir 25 × 800 mg J05AB01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

ADIABEN klorpropamid 30×250mg A10BB02 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

ADVANTAN metilprednizolon tuba 15 g (0,1%) D07AC14 Schering AG, Berlin, Nemčija<br />

ADVANTAN metilprednizolon tuba 15 g (0,1%) D07AC14 Schering AG, Berlin, Nemčija<br />

ADVANTAN brezvodno mazilo metilprednizolon tuba 15 g (0,1%) D07AC14 Schering AG, Berlin, Nemčija<br />

AGLURAB metformin 60 tablet po 500 mg A10BA02 Medis d.o.o., Galex in Gea Slovenija<br />

AKINETON injekcije biperiden 5 ampul po 1 ml raztopine N04AA02 Knoll AG, Ludwigshafen, Nemčija<br />

AKINETON tablete biperiden 50 × 2 mg N04AA02 Knoll AG, Ludwigshafen, Nemčija<br />

ALDACTONE-SALTUCIN butizid 20 oblozˇenih tablet C03EA14 Boehringer Mannheim GmbH, Dunaj Avstrija<br />

ALDACTONE-SALTUCIN butizid 50 oblozˇenih tablet C03EA14 Boehringer Mannheim GmbH, Dunaj Avstrija<br />

ALDACTONE-SALTUCIN FORTE butizid 50 kapsul C03EA14 Boehringer Mannheim GmbH, Dunaj Avstrija<br />

ALDACTONE-SALTUCIN FORTE butizid 20 kapsul C03EA14 Boehringer Mannheim GmbH, Dunaj Avstrija<br />

ALKA-SELTZER acetilsalicilna<br />

kislina<br />

Hrvaška<br />

10 šumečih tablet N02BA01 Bayer Pharma d.o.o. Slovenija<br />

AMINOPHYLLINUM svečke 125 mg aminofilin 5 × 125 mg R03DA05 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

AMINOPHYLLINUM svečke 250 mg aminofilin 5 × 250 mg R03DA05 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

AMINOPHYLLINUM svečke 400 mg aminofilin 5 × 400 mg R03DA05 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

AMINOPHYLLINUM tablete 225 mg aminofilin 20 × 225 mg R03DA05 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

AMINOPLASMAL 10% aminokisline steklenice 1000ml B05BA01 B. Braun Melsungen AG, Melsungen Nemčija<br />

AMINOPLASMAL 10% E aminokisline steklenice 1000ml B05BA01 B. Braun Melsungen AG, Melsungen Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1613


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

AMINOPLASMAL 5% E aminokisline steklenice 1000ml B05BA01 B. Braun Melsungen AG, Melsungen Nemčija<br />

AMINOPLASMAL 5% E aminokisline steklenice 500ml B05BA01 B. Braun Melsungen AG, Melsungen Nemčija<br />

AMINOPLASMAL HEPA 10% aminokisline steklenice 500 ml B05BA01 B. Braun Melsungen AG, Melsungen Nemčija<br />

AMINOSTERIL N-HEPA 5% aminokisline steklenica po 500 ml B05BA01 Fresenius AG, Bad Homburg, Nemčija<br />

AMINOSTERIL N-HEPA 8% aminokisline steklenica po 500 ml B05BA01 Fresenius AG, Bad Homburg, Nemčija<br />

AMOKSICILIN amoksicilin 500×250mg J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOKSICILIN amoksicilin 100×375mg J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOKSICILIN amoksicilin 100×250mg J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOKSICILIN amoksicilin 100×500mg J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOKSICILIN amoksicilin 12×375mg J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOKSICILIN amoksicilin steklenizka 10ml (100mg/1ml), dodati 6ml<br />

destilirane vode<br />

AMOKSICILIN amoksicilin steklenička 100ml (250mg/5ml), dodati<br />

59ml destilirane vode<br />

J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOKSICILIN amoksicilin 500×375mg J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOKSICILIN amoksicilin 500×500mg J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOKSICILIN amoksicilin 1000×375mg J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOKSICILIN amoksicilin 1000×250mg J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOKSICILIN amoksicilin 16×500mg J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOKSICILIN amoksicilin 16×250mg J01CA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMOXIL kapsule 500 mg amoksicilin 16 × 500 mg J01CA04 Pliva d.d., Zagreb Hrvaška<br />

AMOXIL peroralne kapljice amoksicilin steklenička za pripravo 20 ml suspenzije<br />

(100mg/ml)<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

J01CA04 Pliva d.d., Zagreb Hrvaška<br />

AMPICILIN ampicilin steklenička 20 ml (100mg/ml) J01CA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

1614 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

AMPICILIN ampicilin 16×500mg J01CA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMPICILIN ampicilin 100×500mg J01CA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

AMPICILIN peroralna suspenzija<br />

125mg/5ml<br />

ampicilin steklenička s praškom za pripravo 100 ml<br />

suspenzije (125mg/5ml)<br />

J01CA01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

Hrvaška<br />

Hrvaška<br />

d.d., Ljubljana Slovenija<br />

ANAFRANIL drazˇeji klomipramin 30 × 25mg N06AA04 Pliva d.d., Zagreb Hrvaška<br />

ANAFRANIL injekcije klomipramin 10 ampul po 2 ml (25mg/2ml) N06AA04 Pliva d.d., Zagreb Hrvaška<br />

ANEXATE injekcije flumazenil 5 ampul po 5 ml raztopine (0,5mg/5ml) V03AB25 F. Hoffmann-La Roche Ltd., Basel Švica<br />

ANEXATE injekcije flumazenil 5 ampul po 10 ml raztopine (1mg/10ml) V03AB25 F. Hoffmann-La Roche Ltd., Basel Švica<br />

ARTEIN tablete 20 mg lovastatin 20 × 20 mg C10AA02 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

ARTROCAM tenoksikam 10 × 20 mg M01AC02 Pliva d.d., Zagreb Hrvaška<br />

ASPIRIN PLUS C acetilsalicilna 20 šumečih tablet N02BA51 Bayer Pharma d.o.o., Ljubljana,<br />

v sodelovanju z<br />

kislina<br />

Slovenija<br />

Bayer AG, Nemčija<br />

ASPIRIN PLUS C acetilsalicilna<br />

kislina<br />

10 šumečih tablet N02BA51 Bayer Pharma d.o.o. Slovenija<br />

ATENOLOL 100 mg atenolol 14 × 100 mg C07AB03 Pliva d.d., Zagreb Hrvaška<br />

ATENOLOL 50 mg atenolol 30 × 50 mg C07AB03 Pliva d.d., Zagreb Hrvaška<br />

ATGAM antilimfocitni zlozˇenka s 5 ampulami po 5 ml koncentrata L04AA03 Pharmacia & Upjohn Co., Kalamazoo, Pharmacio &<br />

imunoglobulin<br />

ZDA za<br />

Upjohn S.A.,<br />

Luxemburg<br />

ATHYRAZOL tiamazol 30 × 10 mg H03BB02 Jadran, Galenski laboratorij d.d.,<br />

Rijeka, Hrvaška<br />

ATROPINI SULFAS atropin ampule 50×0,5mg/1ml A03BA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

ATROPINI SULFAS atropin ampule 10×0,5mg/1ml A03BA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

ATROPINI SULFAS atropin ampule 10×1mg/1ml A03BA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

ATROPINI SULFAS atropin ampule 50×1mg/1ml A03BA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

BAGOSTEN mazilo 0,1% heksamidin tuba po 30g (1mg/1g) D08AC04 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

BAGOSTEN raztopina 0,1% heksamidin steklenička po 45 ml (1mg/ml) D08AC04 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

BATRAFEN ciklopiroks tuba 50g 1% D01AE14 Hoechst AG, Frankfurt, Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1615


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

BATRAFEN ciklopiroks steklenička po 20ml raztopine (1%) D01AE14 Hoechst AG, Frankfurt, Nemčija<br />

BATRAFEN ciklopiroks steklenička po 50 ml raztopine (1%) D01AE14 Hoechst AG, Frankfurt, Nemčija<br />

BATRAFEN ciklopiroks steklenička po 30 g praška (1%) D01AE14 Hoechst AG, Frankfurt, Nemčija<br />

BATRAFEN ciklopiroks tuba 20g 1% D01AE14 Hoechst AG, Frankfurt, Nemčija<br />

BELOCILLIN benzilpenicilin injekcijske stekleničke 50 × 800.000 I.E. J01CE30 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

BELOCILLIN benzilpenicilin injekcijske stekleničke 50×400.000 I.E. J01CE30 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

BELOCILLIN benzilpenicilin injekcijska steklenička 1×4.000.000 I.E. J01CE30 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

BELOGENT betametazon tuba 30g D07CC01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

BELOGENT betametazon tuba 15g D07CC01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

BELOGENT betametazon tuba 30g D07CC01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

BELOGENT betametazon tuba 15g D07CC01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

BELOMET cimetidin 28×800mg A02BA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

BELOMET cimetidin ampule 10×200mg/2ml A02BA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

BELOMET cimetidin 35×200mg A02BA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

BERIRAB P humani<br />

imunoglob. s<br />

protitelesi proti<br />

virusu stekline<br />

ampule po 5 ml (150 I.E./1 ml) J06BB05 Behring AG/Hoechst Nemčija<br />

BETAFERON interferon beta-1b 15 stekleničk po 0,3 mg interferona beta-1b<br />

in 15 stekleničk po 2 ml topila (0,45%<br />

raztopina natrijevega klorida)<br />

L03AB08 Schering AG, Berlin, Nemčija<br />

BETOPTIC betaksolol plastenka 5ml (5mg/ml) S01ED02 ALCON Pharmaceuticals Ltd. Švica<br />

BETOPTIC S betaksolol plastenka 5ml (0,25%) S01ED02 ALCON Pharmaceuticals Ltd. Švica<br />

BETRION mupirocin tuba po 15g (20mg/1g) D06AX09 Pliva d.d., Zagreb Hrvaška<br />

BISOLEX raztopina bromheksin steklenička po 30 ml (2mg/1ml) R05CB02 Pliva d.d., Zagreb Hrvaška<br />

BISOLEX F tablete bromheksin 20 × 16 mg R05CB02 Pliva d.d., Zagreb Hrvaška<br />

BISOLEX sirup bromheksin steklenička po 200 ml (4mg/5ml) R05CB02 Pliva d.d., Zagreb Hrvaška<br />

1616 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

BISOLEX tablete bromheksin 20 × 8 mg R05CB02 Pliva d.d., Zagreb Hrvaška<br />

BISOLVON peroralne kapljice bromheksin steklenička po 40 ml (2mg/1ml) R05CB02 Boehringer Ingelheim International<br />

GmbH,<br />

BISOLVON tablete bromheksin 20 × 8 mg R05CB02 Boehringer Ingelheim International<br />

GmbH,<br />

Ingelheim am<br />

Rhein<br />

Ingelheim am<br />

Rhein<br />

BONCEFIN injekcije 1 g cefoksitin 5 stekleničk po 1g J01DA05 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

BONCEFIN injekcije 2 g cefoksitin 5 stekleničk po 2g J01DA05 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

BRONILIDE flunizolid zlozˇenka s kovinskim vsebnikom po 6 ml<br />

suspenzije za 120 odmerkov (vsebnik z<br />

zaporko z odmernim ventilom)<br />

BRONILIDE flunizolid zlozˇenka s kovinskim vsebnikom po 6 ml<br />

suspenzije za 120 odmerkov (vsebnik z<br />

zaporko z odmernim ventilom in ustnikom)<br />

R03BA03 Boehringer Ingelheim Pharma KG,<br />

Nemčija za<br />

R03BA03 Boehringer Ingelheim Pharma KG,<br />

Nemčija za<br />

BUSCOPAN injekcije butilskopolamin 5 ampul po 1 ml (20mg/1ml) A03BB01 Boehringer Ingelheim International<br />

GmbH,<br />

BUSCOPAN oblozˇene tablete butilskopolamin 20 × 10 mg A03BB01 Boehringer Ingelheim International<br />

GmbH,<br />

BUSCOPAN svečke butilskopolamin 10 × 10 mg A03BB01 Boehringer Ingelheim International<br />

GmbH,<br />

Boehringer<br />

Ingelheim<br />

International<br />

GmbH<br />

Boehringer<br />

Ingelheim<br />

International<br />

GmbH<br />

Ingelheim am<br />

Rhein<br />

Ingelheim am<br />

Rhein<br />

Ingelheim am<br />

Rhein<br />

C-FILM LUCCHINI nonoksinol-9 vrečke 10×1 film (5×5cm) G02BB Laboratoire Lucchini S.A. Švica<br />

CANESTEN 1 vaginalete klotrimazol 1 × 500 mg G01AF02 Bayer Pharma d.o.o. Slovenija<br />

CANESTEN 1/CANESTEN klotrimazol 1 vaginaleta po 500 mg in tuba po 20 g<br />

kreme (10mg/1g)<br />

G01AF02 Bayer Pharma d.o.o. Slovenija<br />

CANESTEN 3 vaginalete klotrimazol 3 × 200 mg G01AF02 Bayer Pharma d.o.o. Slovenija<br />

CANESTEN 3 vaginalna krema klotrimazol tuba po 20 g (20mg/1g) G01AF02 Bayer Pharma d.o.o. Slovenija<br />

CANESTEN 3/CANESTEN klotrimazol 3 vaginalete po 200 mg, tuba po 20 g kreme<br />

(10mg/1g)<br />

G01AF02 Bayer Pharma d.o.o. Slovenija<br />

CANESTEN krema klotrimazol tuba po 20 g (10mg/1g) D01AC01 Bayer Pharma d.o.o. Slovenija<br />

CANESTEN posipalo klotrimazol plastenka po 30 g (10mg/1g) D01AC01 Bayer Pharma d.o.o. Slovenija<br />

CANESTEN raztopina klotrimazol steklenička po 20 ml (10mg/1ml) D01AC01 Bayer Pharma d.o.o. Slovenija<br />

CARBO MEDICINALIS granule medicinsko oglje 50 g granul (19,25g/50g) A07BA01 Jadran, Galenski laboratorij d.d.,<br />

Rijeka, Hrvaška<br />

CARBO MEDICINALIS tablete medicinsko oglje 30 × 150 mg A07BA01 Jadran, Galenski laboratorij d.d.,<br />

Rijeka, Hrvaška<br />

CECLOR cefaklor steklenička po 60ml (250mg/5ml) J01DA08 Eli Lilly and Company Lim., Velika Eli Lilly Italia<br />

Britanija in<br />

S.p.A., Italija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1617


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

CECLOR cefaklor steklenička po 60ml (125mg/5ml) J01DA08 Eli Lilly and Company Lim., Velika<br />

Britanija in<br />

CECLOR cefaklor 15 × 250mg J01DA08 Eli Lilly and Company Lim., Velika<br />

Britanija in<br />

CECLOR cefaklor 15 × 500 mg J01DA08 Eli Lilly and Company Lim., Velika<br />

Britanija in<br />

Eli Lilly Italia<br />

S.p.A., Italija<br />

Eli Lilly Italia<br />

S.p.A., Italija<br />

Eli Lilly Italia<br />

S.p.A., Italija<br />

CEDAX kapsula ceftibuten zlozˇenka z 10 kapsulami (10 × 200 mg) J01DA39 SIFI S.p.A., Catania, Italija za Schering — Plough<br />

Central East AG,<br />

Luzern, Švica<br />

CEDAX kapsula ceftibuten zlozˇenka s 5 kapsulami (5 × 400 mg) J01DA39 SIFI S.p.A., Catania, Italija za Schering — Plough<br />

Central East AG,<br />

Luzern, Švica<br />

CEDAX suspenzija ceftibuten steklenička za pripravo 60 ml suspenzije J01DA39 SIFI S.p.A., Catania, Italija za Schering — Plough<br />

Central East AG,<br />

Luzern, Švica<br />

CEFALEKSIN cefaleksin steklenička 100ml (250mg/5ml) J01DA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

CEFALEKSIN cefaleksin 100×500mg J01DA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

CEFALEKSIN cefaleksin 16×500mg J01DA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

CEFROM 0,5 cefpirom zlozˇenka s 5 prebodnimi stekleničkami po<br />

0,5 g cefpiroma in s 5 ampulami (ali brez)<br />

po 5 ml vode za injekcije<br />

CEFROM 1,0 cefpirom zlozˇenka s 5 prebodnimi stekleničkami po<br />

1 g cefpiroma in s 5 ampulami (ali brez) po<br />

10 ml vode za injekcije<br />

CEFROM 2,0 cefpirom zlozˇenka s 5 prebodnimi stekleničkami po<br />

2 g cefpiroma in s 5 ampulami (ali brez) po<br />

20 ml vode za injekcije<br />

CEPIVO PROTI DAVICI, TETANUSU<br />

IN OSLOVSKEM KAŠLJU<br />

CEPIVO PROTI DAVICI, TETANUSU<br />

IN OSLOVSKEM KAŠLJU<br />

CEPIVO PROTI DAVICI, TETANUSU<br />

IN OSLOVSKEM KAŠLJU<br />

CEPIVO PROTI OŠPICAM IN<br />

MUMPSU<br />

tetanusni<br />

anatoksin<br />

tetanusni<br />

anatoksin<br />

tetanusni<br />

anatoksin<br />

mešano cepivo<br />

proti ošpicam in<br />

mumpsu z<br />

oslablj.vi<br />

J01DA37 Hoechst Marion Roussel Ltd.,<br />

Covingham, Swindon,<br />

J01DA37 Hoechst Marion Roussel Ltd.,<br />

Covingham, Swindon,<br />

J01DA37 Hoechst Marion Roussel Ltd.,<br />

Covingham, Swindon,<br />

Vel.Britanija za<br />

Hoechst Marion<br />

Roussel<br />

GmbH,Dunaj<br />

Vel.Britanija za<br />

Hoechst Marion<br />

Roussel<br />

GmbH,Dunaj<br />

Vel.Britanija za<br />

Hoechst Marion<br />

Roussel<br />

GmbH,Dunaj<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

1 ampula po 0,5 ml J07AJ51 Imunološki zavod Zagreb Hrvaška<br />

1 steklenička po 5 ml J07AJ51 Imunološki zavod Zagreb Hrvaška<br />

1 steklenička po 10 ml J07AJ51 Imunološki zavod Zagreb Hrvaška<br />

50 stekleničk po 0,5 ml in 50 ampul po<br />

0,5 ml vode za injekcije<br />

J07BD51 Imunološki zavod Zagreb Hrvaška<br />

1618 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

CEPIVO PROTI OŠPICAM IN<br />

MUMPSU<br />

CEPIVO PROTI OŠPICAM IN<br />

MUMPSU<br />

CEPIVO PROTI OŠPICAM IN<br />

MUMPSU<br />

CEPIVO PROTI OŠPICAM, MUMPSU<br />

IN RDEČKAM<br />

CEPIVO PROTI OŠPICAM, MUMPSU<br />

IN RDEČKAM<br />

CEPIVO PROTI OŠPICAM, MUMPSU<br />

IN RDEČKAM<br />

CEPIVO PROTI OŠPICAM, MUMPSU<br />

IN RDEČKAM<br />

CEPIVO PROTI DAVICI IN<br />

TETANUSU<br />

CEPIVO PROTI DAVICI IN<br />

TETANUSU<br />

CEPIVO PROTI DAVICI IN<br />

TETANUSU<br />

mednarodno<br />

nelastniško ime<br />

mešano cepivo<br />

proti ošpicam in<br />

mumpsu z<br />

oslablj.vi<br />

mešano cepivo<br />

proti ošpicam in<br />

mumpsu z<br />

oslablj.vi<br />

mešano cepivo<br />

proti ošpicam in<br />

mumpsu z<br />

oslablj.vi<br />

mešano cepivo<br />

proti ošp.,<br />

mumpsu in<br />

rdečkam z osl.<br />

mešano cepivo<br />

proti ošp.,<br />

mumpsu in<br />

rdečkam z osl.<br />

mešano cepivo<br />

proti ošp.,<br />

mumpsu in<br />

rdečkam z osl.<br />

mešano cepivo<br />

proti ošp.,<br />

mumpsu in<br />

rdečkam z osl.<br />

tetanusni<br />

anatoksin<br />

tetanusni<br />

anatoksin<br />

tetanusni<br />

anatoksin<br />

CEPIVO PROTI MUMPSU cepivo proti<br />

mumpsu z<br />

oslabljenimi<br />

virusi<br />

CEPIVO PROTI MUMPSU cepivo proti<br />

mumpsu z<br />

oslabljenimi<br />

virusi<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

50 ampul po 0,5 ml in 50 ampul po 0,5 ml<br />

vode za injekcije<br />

1 steklenička po 0,5 ml in 1 ampula po<br />

0,5 ml vode za injekcije<br />

1 ampula po 0,5 ml in 1 ampula po 0,5 ml<br />

vode za injekcije<br />

1 steklenička po 0,5 ml in 1 ampula po<br />

0,5 ml vode za injekcije<br />

1 ampula po 0,5 ml in 1 ampula po 0,5 ml<br />

vode za injekcije<br />

50 stekleničk po 0,5 ml in 50 ampul po<br />

0,5 ml vode za injekcije<br />

50 ampul po 0,5 ml in 50 ampul po 0,5 ml<br />

vode za injekcije<br />

J07BD51 Imunološki zavod Zagreb Hrvaška<br />

J07BD51 Imunološki zavod Zagreb Hrvaška<br />

J07BD51 Imunološki zavod Zagreb Hrvaška<br />

J07BD52 Imunološki zavod Zagreb Hrvaška<br />

J07BD52 Imunološki zavod Zagreb Hrvaška<br />

J07BD52 Imunološki zavod Zagreb Hrvaška<br />

J07BD52 Imunološki zavod Zagreb Hrvaška<br />

1 steklenička po 10 ml J07AM51 Imunološki zavod Zagreb Hrvaška<br />

1 ampula po 0,5 ml J07AM51 Imunološki zavod Zagreb Hrvaška<br />

1 steklenička po 5 ml J07AM51 Imunološki zavod Zagreb Hrvaška<br />

50 ampul po 0,5 ml in 50 ampul po 0,5 ml<br />

vode za injekcije<br />

50 stekleničk po 0,5 ml in 50 ampul po<br />

0,5 ml vode za injekcije<br />

J07BE01 Imunološki zavod Zagreb Hrvaška<br />

J07BE01 Imunološki zavod Zagreb Hrvaška<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1619


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

CEPIVO PROTI MUMPSU cepivo proti<br />

mumpsu z<br />

oslabljenimi<br />

virusi<br />

CEPIVO PROTI MUMPSU cepivo proti<br />

mumpsu z<br />

oslabljenimi<br />

virusi<br />

CEPIVO PROTI OŠPICAM cepivo proti<br />

ošpicam z<br />

oslabljenini virusi<br />

CEPIVO PROTI OŠPICAM cepivo proti<br />

ošpicam z<br />

oslabljenini virusi<br />

CEPIVO PROTI OŠPICAM cepivo proti<br />

ošpicam z<br />

oslabljenini virusi<br />

CEPIVO PROTI OŠPICAM cepivo proti<br />

ošpicam z<br />

oslabljenini virusi<br />

CEPIVO PROTI RDEČKAM cepivo proti<br />

rdečkam z<br />

oslabljenimi<br />

virusi<br />

CEPIVO PROTI RDEČKAM cepivo proti<br />

rdečkam z<br />

oslabljenimi<br />

virusi<br />

CEPIVO PROTI RDEČKAM cepivo proti<br />

rdečkam z<br />

oslabljenimi<br />

virusi<br />

CEPIVO PROTI RDEČKAM cepivo proti<br />

rdečkam z<br />

oslabljenimi<br />

virusi<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

1ampula po 0,5 ml in 1 ampula po 0,5 ml<br />

vode za injekcije<br />

1 steklenička po 0,5 ml in 1 ampula po<br />

0,5 ml vode za injekcije<br />

50 stekleničk po 0,5 ml in 50 ampul po<br />

0,5 ml vode za injekcije<br />

1 ampula po 0,5 ml in 1 ampula po 0,5 ml<br />

vode za injekcije<br />

1 steklenička po 0,5 ml in 1 ampula po<br />

0,5 ml vode za injekcije<br />

50 ampul po 0,5 ml in 50 ampul po 0,5 ml<br />

vode za injekcije<br />

1 ampula po 0,5 ml in 1 ampula po 0,5 ml<br />

vode za injekcije<br />

1 steklenička po 0,5 ml in 1 ampula po<br />

0,5 ml vode za injekcije<br />

50 ampul po 0,5 ml in 50 ampul po 0,5 ml<br />

vode za injekcije<br />

50 stekleničk po 0,5 ml in 50 ampul po<br />

0,5 ml vode za injekcije<br />

J07BE01 Imunološki zavod Zagreb Hrvaška<br />

J07BE01 Imunološki zavod Zagreb Hrvaška<br />

J07BD01 Imunološki zavod Zagreb Hrvaška<br />

J07BD01 Imunološki zavod Zagreb Hrvaška<br />

J07BD01 Imunološki zavod Zagreb Hrvaška<br />

J07BD01 Imunološki zavod Zagreb Hrvaška<br />

J07BJ01 Imunološki zavod Zagreb Hrvaška<br />

J07BJ01 Imunološki zavod Zagreb Hrvaška<br />

J07BJ01 Imunološki zavod Zagreb Hrvaška<br />

J07BJ01 Imunološki zavod Zagreb Hrvaška<br />

CEPIVO PROTI TETANUSU tetanusni<br />

anatoksin<br />

1 ampula po 0,5 ml J07AM01 Imunološki zavod Zagreb Hrvaška<br />

CEPIVO PROTI TETANUSU tetanusni<br />

anatoksin<br />

1 steklenička po 5 ml J07AM01 Imunološki zavod Zagreb Hrvaška<br />

CEPIVO PROTI TETANUSU tetanusni<br />

anatoksin<br />

1 steklenička po 10 ml J07AM01 Imunološki zavod Zagreb Hrvaška<br />

CEPOREX kapsule 500 mg cefaleksin 16 × 500mg J01DA01 Pliva d.d., Zagreb Hrvaška<br />

1620 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

CEPOREX suspenzija cefaleksin steklenička po 100ml (250mg/5ml) J01DA01 Pliva d.d., Zagreb Hrvaška<br />

CERSON nitrazepam 30×5mg N05CD02 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

CERSON nitrazepam 10×5mg N05CD02 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

CHENOSAN henodeoksiholna<br />

kislina<br />

Hrvaška<br />

Hrvaška<br />

50×250mg A05AA01 PRO.MED.CS., Praga Češka,<br />

Republika<br />

CHLORAMPHENICOL kapsule kloramfenikol 1000 × 250 mg J01BA01 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

CHLORAMPHENICOL svečke 250 mg kloramfenikol 10 × 250 mg J01BA01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

Slovenija<br />

d.d., Ljubljana Slovenija<br />

CILEST norgestimat 6×21 tablet G03AA11 Cilag AG, Schaffhausen, Švica<br />

CLARINASE psevdoefedrin zlozˇenka z 10 tabletami R01BA52 Schering — Plough Labo N. V., Heistop-den-Berg,<br />

CLINOFUG D 50 doksiciklin 50×50mg J01AA02 Dr. August Wolff & Co., Arzneimittel,<br />

Bielefeld<br />

CLOPIXOL ACUPHASE injekcije cuklopentiksol 5 ampul po 1 ml (50mg/1ml) N05AF05 H. Lundbeck A/S, Copenhagen-Valby, Danska<br />

CLOPIXOL DEPOT injekcije cuklopentiksol 10 ampul po 1 ml (200mg/1ml) N05AF05 H. Lundbeck A/S, Copenhagen-Valby, Danska<br />

CLOPIXOL tablete cuklopentiksol 100 × 10 mg N05AF05 H. Lundbeck A/S, Copenhagen-Valby, Danska<br />

CODEINI PHOSPHATIS kodein 10 × 30mg R05DA04 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

CODEINI PHOSPHATIS kodein 1000 × 30mg R05DA04 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

CONCEPTROL nonoksinol-9 12×150mg G02BB Cilag AG, Schaffhausen, Švica<br />

CORDIPIN tablete nifedipin 50 × 10 mg C08CA05 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

CORDIPIN XL nifedipin 20 × 40 mg C08CA05 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

CORVATON RETARD molsidomin 30×8mg C01DX12 Hoechst AG, Frankfurt, Nemčija<br />

COZAAR losartan zlozˇenka z 28 tabletami po 50 mg (2 × 14<br />

tablet v pretisnem omotu)<br />

C09CA01 MERCK SHARP & DOHME BV<br />

Nizozemska za<br />

MERCK SHARP &<br />

DOHME IDEA,<br />

INC., Švica<br />

CRYSTACILLIN benzilpenicilin 50 stekleničk po 1.000.000 I.E. J01CE01 Pliva d.d., Zagreb Hrvaška<br />

CYNT 0,2 moksonidin zlozˇenka s 30 tabletami C02AC05 Lilly S.A., Alcobendas, Madrid Španija<br />

CYNT 0,3 moksonidin zlozˇenka s 30 tabletami C02AC05 Lilly S.A., Alcobendas, Madrid Španija<br />

Belgija<br />

Nemčija<br />

Slovenija<br />

Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1621


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

CYNT 0,4 moksonidin zlozˇenka s 30 tabletami C02AC05 Lilly S.A., Alcobendas, Madrid Španija<br />

CYTOSAR 1g citarabin zlozˇenka z 1 vialo po 1 g citarabina L01BC01 Pharmacia & Upjohn N.V./S.A., Puurs,<br />

Belgija<br />

CYTOSAR 2 g citarabin zlozˇenka z 1 vialo po 2 g citarabina L01BC01 Pharmacia & Upjohn N.V./S.A., Puurs,<br />

Belgija<br />

DAKTARIN dermalna raztopina mikonazol steklenička po 30 ml (20mg/1ml) D01AC02 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

DAKTARIN injekcije mikonazol 5 ampul po 20 ml (200mg/20ml) J02AB01 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

DAKTARIN krema mikonazol tuba po 30 g (20mg/1g) D01AC02 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

DAKTARIN oralni gel mikonazol tuba po 40 g (20mg/1g) A01AB09 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

DALACIN T raztopina klindamicin zlozˇenka s stekleničko (z aplikatorjem) po<br />

30 ml raztopine<br />

D10AF01 Pharmacia & Upjohn, Alcala De<br />

Henares, Madrid,<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Španija za<br />

Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

DELFEN nonoksinol-9 tuba 70g 5% in aplikator G02BB Cilag AG, Schaffhausen, Švica<br />

DEMETRIN prazepam 20 tablet po 10 mg N05BA11 Gödecke AG, Freiburg/Parke-Davis<br />

GmbH Berlin,<br />

Freiburg Nemčija<br />

DERMATOP KREMA prednikarbat tuba po 50 g kreme (2,5mg/1g) D07AC18 Hoechst AG, Frankfurt, Nemčija<br />

DERMATOP KREMA prednikarbat tuba po 10 g kreme (2,5mg/1g) D07AC18 Hoechst AG, Frankfurt, Nemčija<br />

DERMATOP MAZILO prednikarbat tuba po 50 g mazila D07AC18 Hoechst AG, Frankfurt, Nemčija<br />

DERMATOP MAZILO prednikarbat tuba po 10 g mazila D07AC18 Hoechst AG, Frankfurt, Nemčija<br />

DIAPREL gliklazid 60 tablet × 80 mg A10BB09 Les Laboratoires Servier Industrie,<br />

Gidy,<br />

Francija<br />

DIENOESTROL ORTHO dienestrol tuba po 78 g kreme (0.01%) z aplikatorjem G03CB01 Cilag AG, Schaffhausen, Švica<br />

DIFETOIN fenitoin 100 × 100mg N03AB02 Pliva d.d., Zagreb Hrvaška<br />

DIFLUCAN prašek za peroralno flukonazol steklenička po 35 ml (50mg/5ml) J02AC01 Pfizer Products Corporation,<br />

Belgija<br />

suspenzijo<br />

Zaventem,<br />

DIFLUCAN prašek za peroralno flukonazol steklenička po 35 ml (200mg/5ml) J02AC01 Pfizer Products Corporation,<br />

Belgija<br />

suspenzijo<br />

Zaventem,<br />

DILTIAZEM 60 mg diltiazem 30 × 60mg C08DB01 Pliva d.d., Zagreb Hrvaška<br />

DILTIAZEM 90 mg diltiazem 30 × 90mg C08DB01 Pliva d.d., Zagreb Hrvaška<br />

DIPIDOLOR piritramid ampule 5×20mg/2ml raztopine N02AC03 Janssen-Cilag, Beerse Belgija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

1622 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

DIPIRIDAMOL dipiridamol 15×75mg B01AC07 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

DIPIVEFRIN dipivefrin plastenka po 5 ml S01EA02 ALCON Pharmaceuticals Ltd. Švica<br />

DISTRANEVRIN klometiazol 50 kapsul × 200 mg N05CM02 Astra Chemicals GmbH, Wedel,<br />

Holstein<br />

DISTRANEVRIN klometiazol 25 kapsul × 200 mg N05CM02 Astra Chemicals GmbH, Wedel,<br />

Holstein<br />

DISTRANEVRIN klometiazol steklenička po 500 ml raztopine N05CM02 Astra Chemicals GmbH, Wedel,<br />

Holstein<br />

DITAMIN injekcije 1mg/1ml dihidroergotamin 50 ampul po 1 ml (1mg/1ml) N02CA01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

DITAMIN raztopina dihidroergotamin steklenička po 30 ml (2 mg/ml) N02CA01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

DITAMIN tablete 2,5 mg dihidroergotamin 20 tablet × 2,5 mg N02CA01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

Hrvaška<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

DOBUTREX dobutamin steklenička po 250mg C01CA07 Lilly France S.A., Fegersheim Francija<br />

DOKSICIKLIN doksiciklin 6×100mg J01AA02 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

DOKSICIKLIN doksiciklin 100×100mg J01AA02 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

DOKSICIKLIN doksiciklin 25×100mg J01AA02 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

DUOBLOC zˇvečljive tablete aluminijev<br />

hidroksid<br />

DUOBLOC zˇvečljive tablete aluminijev<br />

hidroksid<br />

60 tablet A02AF02 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

20 tablet A02AF02 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

DYNABAC diritromicin 10 × 250 mg J01FA13 Eli Lilly (Suisse) S.A. Švica<br />

EBRANTIL 25 urapidil ampule 5×25mg/5ml C02CA06 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

EBRANTIL 30 urapidil 50×30mg C02CA06 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

EBRANTIL 50 urapidil ampule 5×50mg/10ml C02CA06 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

EDICIN kapsule 125 mg vankomicin 20 × 125 mg A07AA09 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

EDICIN kapsule 250 mg vankomicin 20 × 250 mg A07AA09 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

Konstanz Nemčija<br />

Konstanz Nemčija<br />

Konstanz Nemčija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1623


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

EGLONYL FORTE sulpirid 12 × 200 mg N05AL01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

EGLONYL injekcije sulpirid 30 ampul po 2 ml (100mg/2ml) N05AL01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

EGLONYL kapsule sulpirid 30 × 50 mg N05AL01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

EGLONYL peroralna raztopina sulpirid steklenizka po 120 ml (5mg/1ml) N05AL01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

ELDERIN SR tablete 600 mg etodolak 20 × 600 mg M01AB08 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

ELMOGAN tablete 450 mg gemfibrozil 100 × 450 mg C10AB04 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

ELMOGAN tablete 600 mg gemfibrozil 100 × 600 mg C10AB04 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

ELMOGAN tablete 450 mg gemfibrozil 30 × 450 mg C10AB04 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

ELMOGAN tablete 600 mg gemfibrozil 30 × 600 mg C10AB04 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

ELOCOM mometazon tuba po 50 g (1mg/g) D07AC13 Schering — Plough Labo N. V., Heistop-den-Berg,<br />

Belgija<br />

ELOCOM mometazon tuba po 50 g (1 mg/g) D07AC13 Schering — Plough Labo N. V., Heistop-den-Berg,<br />

Belgija<br />

ELOCOM mometazon plastenka po 100 ml (1mg/g) D07AC13 Schering — Plough Labo N. V., Heistop-den-Berg,<br />

Belgija<br />

ELOCOM mometazon zlozˇenka s tubo po 15 g kreme D07AC13 Schering — Plough Labo N. V., Heistop-den-Berg,<br />

Belgija<br />

ELOCOM mometazon zlozˇenka s tubo po 15 g mazila D07AC13 Schering — Plough Labo N. V., Heistop-den-Berg,<br />

Belgija<br />

ELOCOM mometazon zlozˇenka s plastenko po 20 ml raztopine D07AC13 Schering — Plough Labo N. V., Heistop-den-Berg,<br />

Belgija<br />

ELOHAEST 6% hetaškrob steklenica 10×250ml B05AA07 Leopold Pharma GmbH, Graz, Avstrija<br />

ELOHAEST 6% hetaškrob plastenke 10×500ml B05AA07 Leopold Pharma GmbH, Graz, Avstrija<br />

ELOHAEST 6% hetaškrob steklenice 10×500ml B05AA07 Leopold Pharma GmbH, Graz, Avstrija<br />

ELOHAEST 6% hetaškrob plastične vrečke 10×500ml B05AA07 Leopold Pharma GmbH, Graz, Avstrija<br />

EMLA 5 % lidokain 5 tub po 5 g kreme N01BB20 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

Švedska<br />

ENAP 5 enalapril 20 × 5 mg C09AA02 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

Slovenija<br />

1624 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

ENAP-H enalapril 20 × C09BA02 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

ENDOBULIN humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

ENDOBULIN humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

ENDOBULIN humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

ENDOBULIN humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

ENDOBULIN humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

ENDOBULIN humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

ENDOBULIN humani<br />

imunoglobulini<br />

za<br />

intravaskularno<br />

aplikacijo<br />

steklenička 1×500mg in steklenička 1×10ml<br />

vode za injekcije<br />

steklenička 1×250mg in steklenička 1×5ml<br />

vode za injekcije<br />

steklenička 1×10.000mg in steklenička<br />

1×200ml vode za injekcije<br />

steklenička 1×5.000mg in steklenička<br />

1×100ml vode za injekcije, ter set za<br />

raztapljanje in injiciranje<br />

steklenička 1×1.000mg in steklenička<br />

1×20ml vode za injekcije<br />

steklenička 1×7.500mg in steklenička<br />

1×150ml vode za injekcije<br />

steklenička 1×2.500mg in steklenička<br />

1×50ml vode za injekcije in set za<br />

raztapljanje in injiciranje<br />

Slovenija<br />

J06BA02 Immuno AG, Dunaj, Avstrija<br />

J06BA02 Immuno AG, Dunaj, Avstrija<br />

J06BA02 Immuno AG, Dunaj, Avstrija<br />

J06BA02 Immuno AG, Dunaj, Avstrija<br />

J06BA02 Immuno AG, Dunaj, Avstrija<br />

J06BA02 Immuno AG, Dunaj, Avstrija<br />

J06BA02 Immuno AG, Dunaj, Avstrija<br />

ENDOXAN ciklofosfamid 1 viala × 1 g L01AA01 Asta Medica AG, Frankfurt am Main Nemčija<br />

ENDOXAN ciklofosfamid 1 viala × 500 mg L01AA01 Asta Medica AG, Frankfurt am Main Nemčija<br />

ENDOXAN ciklofosfamid 100 drazˇejev × 50 mg L01AA01 Asta Medica AG, Frankfurt am Main Nemčija<br />

ENDOXAN ciklofosfamid 25 drazˇejev × 50 mg L01AA01 Asta Medica AG, Frankfurt am Main Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1625


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

ENDOXAN ciklofosfamid 50 drazˇejev × 50 mg L01AA01 Asta Medica AG, Frankfurt am Main Nemčija<br />

ENDOXAN ciklofosfamid 10 vial × 100 mg L01AA01 Asta Medica AG, Frankfurt am Main Nemčija<br />

ENDOXAN ciklofosfamid 10 vial × 200 mg L01AA01 Asta Medica AG, Frankfurt am Main Nemčija<br />

EPREX epoetin alfa,<br />

rekombinantni<br />

humani<br />

EPREX epoetin alfa,<br />

rekombinantni<br />

humani<br />

EPREX epoetin alfa,<br />

rekombinantni<br />

humani<br />

EPREX epoetin alfa,<br />

rekombinantni<br />

humani<br />

EPREX epoetin alfa,<br />

rekombinantni<br />

humani<br />

EPREX epoetin alfa,<br />

rekombinantni<br />

humani<br />

napolnjene injekcijske brizge<br />

6×10.000i.e./ml<br />

B03XA01 Cilag AG, Schaffhausen, Švica<br />

ampule 6×4.000I.E./1ml B03XA01 Cilag AG, Schaffhausen, Švica<br />

napolnjene injekcijske brizge<br />

6×3.000i.e./0,3ml<br />

napolnjene injekcijske brizge<br />

6×4.000i.e./0,4ml<br />

B03XA01 Cilag AG, Schaffhausen, Švica<br />

B03XA01 Cilag AG, Schaffhausen, Švica<br />

ampule 6×2.000I.E./1ml B03XA01 Cilag AG, Schaffhausen, Švica<br />

napolnjene injekcijske brizge<br />

6×2.000i.e./0,5ml<br />

B03XA01 Cilag AG, Schaffhausen, Švica<br />

ERITROMICIN eritromicin 100×250mg J01FA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

ERITROMICIN eritromicin 16×250mg J01FA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

ESTRACYT estramustin 100 × 140mg L01XX11 Pliva d.d., Zagreb Hrvaška<br />

ESTRADERM TTS 100 estradiol 6 oblizˇev velikosti 20 cm × cm (8 mg/oblizˇ) G03CA03 Novartis Pharma AG, Basel Švica<br />

ESTRADERM TTS 25 estradiol 6 oblizˇev velikosti 5 cm × cm (2 mg/oblizˇ) G03CA03 Novartis Pharma AG, Basel Švica<br />

ESTRADERM TTS 50 estradiol 6 oblizˇev velikosti 10 cm × cm (4 mg/oblizˇ) G03CA03 Novartis Pharma AG, Basel Švica<br />

EUTIZON B6 izoniazid 50 kapsul J04AC51 Pliva d.d., Zagreb Hrvaška<br />

FEIBA TIM 4 kombinacije<br />

koagulacijskih<br />

faktorjev IX, II,<br />

VII in X<br />

FEIBA TIM 4 kombinacije<br />

koagulacijskih<br />

faktorjev IX, II,<br />

VII in X<br />

steklenička 1×1000 I.E. in steklenička<br />

1×20ml vode za injekcije ter pribor za<br />

raztapljanje in injiciranje<br />

steklenička 1×500I.E. in steklenička 1×20ml<br />

vode za injekcije, ter pribor za raztapljanje<br />

in injiciranje<br />

Hrvaška<br />

Hrvaška<br />

Immuno AG, Dunaj, Avstrija<br />

Immuno AG, Dunaj, Avstrija<br />

1626 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

FEIBA TIM 4 kombinacije<br />

koagulacijskih<br />

faktorjev IX, II,<br />

VII in X<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

steklenička 1×250 I.E. in steklenička 1×20ml<br />

vode za injekcije ter pribor za raztapljanje in<br />

injiciranje<br />

Immuno AG, Dunaj, Avstrija<br />

FEMODEN gestoden in<br />

estrogen<br />

21 drazˇejev G03AA10 Schering AG, Berlin, Nemčija<br />

FEMSTAT butokonazol tuba 20g 2% G01AF15 Syntex Pharmaceutica AG, Allschwil, Švica<br />

FEMSTAT butokonazol 3×100mg G01AF15 Syntex Pharmaceutica AG, Allschwil, Švica<br />

FENTANYL fentanil ampule 50×0,1mg/2ml N01AH01 Janssen-Cilag, Beerse Belgija<br />

FENTANYL fentanil ampule 50×0,5mg/10ml N01AH01 Janssen-Cilag, Beerse Belgija<br />

FENWAL (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

FENWAL (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

FENWAL (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

FENWAL (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

FENWAL (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

FENWAL (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

FENWAL (krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

FENWAL ZAPRTI SET ZA<br />

HEMOFEREZO<br />

(krvne transfuzije,<br />

pomozˇni<br />

pripravki)<br />

plastične vrečke, 25 trojnih odvzemnih<br />

sistemov (primarna vrečka 450 ml s 63 ml<br />

antikoagulacijske raztopine CPD s 100 ml<br />

raztopine SAG-M)<br />

plastične vrečke, 30 trojnih odvzemnih<br />

sistemov (450 ml s 63 ml antikoagulacijske<br />

raztopine CPDA-1 in dve vrečki za<br />

trombocite 400 ml)<br />

plastične vrečke, 30 dvojnih odvzemnih<br />

sistemov (450 ml s 63 ml antikoagulacijske<br />

raztopine CPD in vrečka za trombocite<br />

400 ml)<br />

plastične vrečke, 30 dvojnih odvzemnih<br />

sistemov (350 ml z 49 ml antikoagulacijske<br />

raztopine CPD in vrečka za trombocite<br />

400 ml)<br />

plastične vrečke, 25 trojnih odvzemnih<br />

sistemov (primarna vrečka 350 ml, z 49 ml<br />

antikoagulacijske raztopine CPD z 80 ml<br />

raztopine SAG-M)<br />

plastične vrečke, 50 enojnih odvzemnih<br />

sistemov (450 ml s 63 ml antikoagulacijske<br />

raztopine CPDA-1)<br />

plastične vrečke, 50 enojnih odvzemnih<br />

sistemov (350 ml z 49 ml antikoagulacijske<br />

raztopine CPDA-1)<br />

set za zbiranje komponent krvi s celičnim<br />

separatorjem<br />

V07AC Baxter Export Corporation, Miami, ZDA<br />

V07AC Baxter Export Corporation, Miami, ZDA<br />

V07AC Baxter Export Corporation, Miami, ZDA<br />

V07AC Baxter Export Corporation, Miami, ZDA<br />

V07AC Baxter Export Corporation, Miami, ZDA<br />

V07AC Baxter Export Corporation, Miami, ZDA<br />

V07AC Baxter Export Corporation, Miami, ZDA<br />

V07AC Baxter Export Corporation, Miami, ZDA<br />

FINALGON mazilo nonivamid tuba po 20g M02AB Boehringer Ingelheim International<br />

GmbH,<br />

Ingelheim am<br />

Rhein<br />

FIZIOLOŠKA RAZTOPINA natrijev klorid infuzijska steklenica po 500 ml (0,9%) B05BB01 Pliva d.d., Zagreb Hrvaška<br />

FIZIOLOŠKA RAZTOPINA natrijev klorid PVC vrečka po 2000 ml (18g/2000ml) B05BB01 Pliva d.d., Zagreb Hrvaška<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1627


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

FIZIOLOŠKA RAZTOPINA natrijev klorid PVC vrečka po 1000 ml (9g/1000ml) B05BB01 Pliva d.d., Zagreb Hrvaška<br />

FLIXOTIDE 125 INHALER flutikazon inhalator za 120 inhalacij R03BA05 Glaxo Group Limited, London Velika<br />

Britanija<br />

FLIXOTIDE 25 INHALER flutikazon inhalator za 120 inhalacij R03BA05 Glaxo Group Limited, London Velika<br />

Britanija<br />

FLIXOTIDE 250 INHALER flutikazon inhalator za 120 inhalacij R03BA05 Glaxo Group Limited, London Velika<br />

Britanija<br />

FLIXOTIDE 50 INHALER flutikazon inhalator za 120 inhalacij R03BA05 Glaxo Group Limited, London Velika<br />

Britanija<br />

FLIXOTIDE DISKUS 100 flutikazon 1 diskus (=60 inhalacij) × 100 µg R03BA05 Glaxo Wellcome Operations,<br />

Greenford<br />

FLIXOTIDE DISKUS 250 flutikazon 1 diskus (=60 inhalacij) × 250 µg R03BA05 Glaxo Wellcome Operations,<br />

Greenford<br />

FLIXOTIDE DISKUS 50 flutikazon 1 diskus (=60 inhalacij) × 50 µg R03BA05 Glaxo Wellcome Operations,<br />

Greenford<br />

FLIXOTIDE DISKUS 500 flutikazon 1 diskus (=60 inhalacij) × 500 µg R03BA05 Glaxo Wellcome Operations,<br />

Greenford<br />

FLUANXOL DEPOT flupentiksol 10 ampul po 1 ml (20mg/1ml) N05AF01 H. Lundbeck A/S, Copenhagen-Valby, Danska<br />

FLUANXOL DEPOT flupentiksol 10 ampul po 2 ml (40mg/2ml) N05AF01 H. Lundbeck A/S, Copenhagen-Valby, Danska<br />

FLUANXOL oblozˇene tablete flupentiksol zlozˇenka s plastičnim vsebnikom po 100<br />

tablet<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

N05AF01 H. Lundbeck A/S, Copenhagen-Valby, Danska<br />

FLUOTHANE halotan steklenička po 250 ml N01AB01 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

FOLACIN folna kislina 20 × 5 mg B03BB01 Jadran, Galenski laboratorij d.d.,<br />

Rijeka, Hrvaška<br />

FORANE izofluran steklenička po 100 ml tekočine za<br />

inhaliranje<br />

FORTALGIN C šumeče tablete acetilsalicilna<br />

kislina<br />

FOSAMAX alendronska<br />

kislina<br />

Velika<br />

Britanija<br />

N01AB06 Abbott Laboratoires SA Švica<br />

10 šumečih tablet N02BA51 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

28 × 10 mg M05BA04 MSD Pavia, Italija ali MSD Haarlem,<br />

Nizozemska<br />

FRISIUM 10 klobazam zlozˇenka s 50 tabletami N05BA09 Usiphar, Groupe Hoechst Marion<br />

Roussel, Francija<br />

FRISIUM 10 klobazam zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

N05BA09 Usiphar, Groupe Hoechst Marion<br />

Roussel, Francija<br />

d.d., Ljubljana Slovenija<br />

za Merck Sharp &<br />

Dohme IDEA Inc.,<br />

Švica<br />

za Hoechst Marion<br />

Roussel GmbH,<br />

Dunaj, Avstrija<br />

za Hoechst Marion<br />

Roussel GmbH,<br />

Dunaj, Avstrija<br />

1628 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

FSME-BULIN humani<br />

imunoglobulin<br />

proti klopnemu<br />

meningoencefalitisu<br />

FSME-BULIN humani<br />

imunoglobulin<br />

proti klopnemu<br />

meningoencefalitisu<br />

FSME-BULIN humani<br />

imunoglobulin<br />

proti klopnemu<br />

meningoencefalitisu<br />

FSME-BULIN humani<br />

imunoglobulin<br />

proti klopnemu<br />

meningoencefalitisu<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

1 steklenička po 1ml raztopine J06BB12 Immuno AG, Dunaj, Avstrija<br />

1steklenička po 10 ml raztopine J06BB12 Immuno AG, Dunaj, Avstrija<br />

1 steklenička po 5 ml raztopine J06BB12 Immuno AG, Dunaj, Avstrija<br />

1 steklenička po 2 ml raztopine J06BB12 Immuno AG, Dunaj, Avstrija<br />

FURSEMID furosemid 100×40mg C03CA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

FURSEMID furosemid 12×40mg C03CA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

FURSEMID furosemid ampule 5×20mg/2ml C03CA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

GENOTAN tablete 4 mg metilprednizolon 30 × 4 mg H02AB04 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

GENTAMICIN gentamicin ampule 10×120.000i.e./2ml J01GB03 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

GENTAMICIN gentamicin ampule 10×40.000i.e./2ml J01GB03 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

GENTAMICIN gentamicin ampule 10×80.000i.e./2ml J01GB03 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

GEOKORTON kapljice za oko in uho oksitetraciklin plastenka po 5 ml S03CA04 Pliva d.d., Zagreb Hrvaška<br />

GEOKORTON mazilo oksitetraciklin tuba po 20 g mazila D07CA01 Pliva d.d., Zagreb Hrvaška<br />

GEOMYCIN oksitetraciklin 16 × 250 mg J01AA06 Pliva d.d., Zagreb Hrvaška<br />

GLUCOSUM 25 % injekcije glukoza 50 ampul × 10 ml (25%) B05BA03 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

GLUCOSUM 37 % injekcije glukoza 50 ampul × 10 ml (37%) B05BA03 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1629


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

GLUCOSUM 50 % injekcije glukoza 50 ampul × 10 ml (50%) B05BA03 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

GLUKOZA 40% glukoza plastične ampule iz PE 20×8g/20ml B05BA03 B. Braun Melsungen AG, Melsungen Nemčija<br />

GLUKOZA 40% glukoza plastične ampule iz PE 20×4g/10ml B05BA03 B. Braun Melsungen AG, Melsungen Nemčija<br />

GLUKOZA 40% glukoza plastenke iz PE 10×200g/500ml B05BA03 B. Braun Melsungen AG, Melsungen Nemčija<br />

GLUKOZA 70% glukoza steklenice 10×350g/500ml B05BA03 B. Braun Melsungen AG, Melsungen Nemčija<br />

GLURENORM tablete glikvidon 60 × 30mg A10BB08 Boehringer Ingelheim International<br />

GmbH,<br />

Ingelheim am<br />

Rhein<br />

GOPTEN 0,5 mg trandolapril 50 kapsul po 0,5 mg C09AA10 Knoll AG, Ludwigshafen, Nemčija<br />

GOPTEN 2,0 mg trandolapril 28 kapsul po 2 mg C09AA10 Knoll AG, Ludwigshafen, Nemčija<br />

GYNIPRAL injekcije heksoprenalin 5 ampul po 4 ml (0,01mg/4ml) R03CC05 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

GYNIPRAL tablete heksoprenalin 20 × 0,5 mg R03CC05 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

HAEMATOPAN 100 zˇelezov(II) sulfat 50 tablet B03AA07 Dr. August Wolff & Co., Arzneimittel,<br />

Bielefeld<br />

HAEMATOPAN 100 zˇelezov(II) sulfat 100 tablet B03AA07 Dr. August Wolff & Co., Arzneimittel,<br />

Bielefeld<br />

HAEMATOPAN 100 zˇelezov(II) sulfat 20 tablet B03AA07 Dr. August Wolff & Co., Arzneimittel,<br />

Bielefeld<br />

HAEMATOPAN 50 zˇelezov(II) sulfat 50 tablet B03AA07 Dr. August Wolff & Co., Arzneimittel,<br />

Bielefeld<br />

HAEMATOPAN 50 zˇelezov(II) sulfat 100 tablet B03AA07 Dr. August Wolff & Co., Arzneimittel,<br />

Bielefeld<br />

HAEMATOPAN 50 zˇelezov(II) sulfat 20 tablet B03AA07 Dr. August Wolff & Co., Arzneimittel,<br />

Bielefeld<br />

HEMOFIL M koagulacijski<br />

faktor VIII<br />

HEMOFIL M koagulacijski<br />

faktor VIII<br />

HEMOFIL M koagulacijski<br />

faktor VIII<br />

1 steklenička 1000 I.E. in 1 × 10 ml vode za<br />

injekcije, pribor za apliciranje<br />

1 steklenička 500 I.E. in 1 × 10 ml vode za<br />

injekcije, pribor za apliciranje<br />

1 steklenička 250 I.E. in 1 × 10 ml vode za<br />

injekcije, set za apliciranje<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

B02BD02 Baxter Export Corporation, Miami, ZDA<br />

B02BD02 Baxter Export Corporation, Miami, ZDA<br />

B02BD02 Baxter Export Corporation, Miami, ZDA<br />

HEPATHROMBIN 50000 gel heparin tuba 40g C05BA53 Gödecke AG, Freiburg/Parke-Davis<br />

GmbH Berlin,<br />

HEPATHROMBIN 50000 mazilo heparin tuba 40g C05BA53 Gödecke AG, Freiburg/Parke-Davis<br />

GmbH Berlin,<br />

Freiburg Nemčija<br />

Freiburg Nemčija<br />

1630 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

HEPAVIT hidroksokobalamin<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

ampule 2 × 2 ml B03BA03 Frika Pharmazeutische Fabrik<br />

Ges.m.b.H., Dunaj<br />

HEXORAL heksetidin steklenica 200ml (1mg/1ml) A01AB12 Gödecke AG, Freiburg/Parke-Davis<br />

GmbH Berlin,<br />

HOLETAR 20 mg lovastatin 20 × 20 mg C10AA02 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

HOLETAR 40 mg lovastatin 20 × 40 mg C10AA02 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

HUMATROPE somatropin,<br />

rekombinantni<br />

humani<br />

HUMULIN L (LENTE) insulin, človeški,<br />

rekombinantni<br />

HUMULIN M1 (10/90) insulin, človeški,<br />

rekombinantni<br />

HUMULIN M1 (10/90) insulin, človeški,<br />

rekombinantni<br />

HUMULIN M2 (20/80) insulin, človeški,<br />

rekombinantni<br />

HUMULIN M2 (20/80) insulin, človeški,<br />

rekombinantni<br />

HUMULIN M3 (30/70) insulin, človeški,<br />

rekombinantni<br />

HUMULIN M3 (30/70) insulin, človeški,<br />

rekombinantni<br />

HUMULIN M4 (40/60) insulin, človeški,<br />

rekombinantni<br />

HUMULIN M4 (40/60) insulin, človeški,<br />

rekombinantni<br />

HUMULIN N (NPH) insulin, človeški,<br />

rekombinantni<br />

HUMULIN N (NPH) insulin, človeški,<br />

rekombinantni<br />

HUMULIN R (REGULAR) insulin, človeški,<br />

rekombinantni<br />

HUMULIN R (REGULAR) insulin, človeški,<br />

rekombinantni<br />

1 steklenizka po 4 I.E. in 1 steklenizka po<br />

2ml topila<br />

Avstrija<br />

Freiburg Nemčija<br />

Slovenija<br />

Slovenija<br />

H01AC01 Lilly France S.A., Fegersheim Francija<br />

steklenizka 1×400I.E./10ml suspenzije Eli Lilly Avstrija Avstrija<br />

steklenizka 1×400I.E./10ml suspenzije Eli Lilly Avstrija Avstrija<br />

vlozˇki za uporabo v injekcijskem peresu<br />

5×150I.E./1,5ml suspenzije<br />

Eli Lilly Avstrija Avstrija<br />

steklenička 1×400I.E./10ml suspenzije Eli Lilly Avstrija Avstrija<br />

vlozˇki za uporabo v injekcijskem peresu<br />

5×150I.E./1,5ml suspenzije<br />

Eli Lilly Avstrija Avstrija<br />

steklenička 1×400I.E./10ml suspenzije Eli Lilly Avstrija Avstrija<br />

vlozˇki za uporabo v injekcijskem peresu<br />

5×150I.E./1,5ml suspenzije<br />

vlozˇki za uporabo v injekcijskem peresu<br />

5×150I.E./1,5ml suspenzije<br />

Eli Lilly Avstrija Avstrija<br />

Eli Lilly Avstrija Avstrija<br />

steklenička 1×400I.E./10ml suspenzije Eli Lilly Avstrija Avstrija<br />

injekcijska steklenička 400 I.E./10ml A10AC01 Lilly France S.A., Fegersheim Francija<br />

vlozˇki za uporabo v injekcijskem peresu<br />

5 × 150 I.E./1,5ml<br />

A10AC01 Lilly France S.A., Fegersheim Francija<br />

injekcijska steklenička 400 I.E./10ml A10AB01 Lilly France S.A., Fegersheim Francija<br />

vlozˇki za uporabo v injekcijskem peresu<br />

5×150 I.E../1,5ml<br />

HYDROCORTISON HOECHST hidrokortizon zlozˇenka z 20 tabletami po 10 mg (2 × 10<br />

tablet v pretisnem omotu)<br />

A10AB01 Lilly France S.A., Fegersheim Francija<br />

H02AB09 Hoechst Marion Roussel S.p.A.,<br />

Scoppito, Italija<br />

za Hoechst Marion<br />

Roussel<br />

Deutschland GmbH<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1631


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

IBUPROFEN ibuprofen 30 × 400 mg M01AE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

IBUPROFEN ibuprofen 30 × 200 mg M01AE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

IBUPROFEN ibuprofen 30 × 600 mg M01AE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

IMIGRAN sumatriptan 2 injekcijski brizgi po 0,5 ml (6 mg/0,5 ml)<br />

in 1 Glaxov avtoinjektor<br />

N02CC01 Glaxo Wellcome S.p.A., Italija za<br />

Glaxo Wellcome<br />

INDOMETACIN indometacin 10 × 100 mg M01AB01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

INDOMETACIN indometacin 30 × 25 mg M01AB01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

INTRALIPID 10% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

INTRALIPID 10% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

INTRALIPID 20% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

INTRALIPID 20% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

INTRALIPID 20% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

INTRALIPID 20% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

zlozˇenka z 12 steklenicami po 500 ml<br />

emulzije<br />

zlozˇenka z 12 stekleničkami po 100 ml<br />

emulzije<br />

zlozˇenka s 6 steklenicami po 1000 ml<br />

emulzije<br />

zlozˇenka z 12 stekleničkami po 100 ml<br />

emulzije<br />

zlozˇenka z 12 stekleničkami po 250 ml<br />

emulzije<br />

zlozˇenka z 12 steklenicami po 500 ml<br />

emulzije<br />

B05BA02 Pharmacia & Upjohn AB, Švedska, za<br />

Pharmacio &<br />

B05BA02 Pharmacia & Upjohn AB, Švedska, za<br />

Pharmacio &<br />

B05BA02 Pharmacia & Upjohn AB, Švedska, za<br />

Pharmacio &<br />

B05BA02 Pharmacia & Upjohn AB, Švedska, za<br />

Pharmacio &<br />

B05BA02 Pharmacia & Upjohn AB, Švedska, za<br />

Pharmacio &<br />

B05BA02 Pharmacia & Upjohn AB, Švedska, za<br />

Pharmacio &<br />

Export Ltd., Velika<br />

Britanija<br />

Upjohn S.A.<br />

Luxemburg<br />

Upjohn S.A.<br />

Luxemburg<br />

Upjohn S.A.<br />

Luxemburg<br />

Upjohn S.A.<br />

Luxemburg<br />

Upjohn S.A.<br />

Luxemburg<br />

Upjohn S.A.<br />

Luxemburg<br />

IOPAMIRO 150 jopamidol steklenička 250 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 150 jopamidol steklenička 100 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 150 jopamidol steklenička 50 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 200 jopamidol ampula 1 × 10 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 200 jopamidol ampule 5 × 10 ml V08AB04 Bracco S.p.A., Milano Italija<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

1632 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

IOPAMIRO 300 jopamidol steklenička 200 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 300 jopamidol steklenička 100 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 300 jopamidol steklenička 50 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 300 jopamidol ampule 5 × 10 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 300 jopamidol steklenička 30 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 300 jopamidol ampula 1 × 10 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 370 jopamidol steklenička 200 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 370 jopamidol steklenička 30 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 370 jopamidol steklenička 50 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 370 jopamidol steklenička 100 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPAMIRO 370 jopamidol ampula 1 × 10 ml V08AB04 Bracco S.p.A., Milano Italija<br />

IOPIDINE apraklonidin plastenka po 5 ml S01EA03 ALCON Pharmaceuticals Ltd. Švica<br />

IRUMED lizinopril 20×5mg C09AA03 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

IRUMED lizinopril 20×20mg C09AA03 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

IRUMED lizinopril 20×10mg C09AA03 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

ISOMONAT 20 izosorbidmononitrat<br />

20×20mg C01DA14 Boehringer Mannheim GmbH, Dunaj Avstrija<br />

ISOMONAT 20 izosorbidmononitrat<br />

60×20mg C01DA14 Boehringer Mannheim GmbH, Dunaj Avstrija<br />

IZOTONIČNA RAZTOPINA<br />

NATRIJEVEGA KLORIDA 0,9%<br />

BRAUN<br />

natrijev klorid plastične ampule iz PE 20×0,045g/5ml V07AB B. Braun Melsungen AG, Melsungen Nemčija<br />

KALIJ KLORID kalijev klorid 20×500mg A12BA01 Jadran, Galenski laboratorij d.d.,<br />

Rijeka, Hrvaška<br />

KEFLEX cefaleksin steklenička s praškom za pripravo 60ml<br />

suspenzije (125/5ml)<br />

J01DA01 Eli Lilly Avstrija Avstrija<br />

KEFLEX cefaleksin 100×500mg J01DA01 Eli Lilly Avstrija Avstrija<br />

KEFLEX cefaleksin 12×500mg J01DA01 Eli Lilly Avstrija Avstrija<br />

KEFLEX cefaleksin 100 × 250mg J01DA01 Eli Lilly Avstrija Avstrija<br />

KEFLEX cefaleksin 12×250mg J01DA01 Eli Lilly Avstrija Avstrija<br />

KEFLEX cefaleksin steklenička s praškom za pripravo 60 ml<br />

suspenzije (250mg/5ml)<br />

J01DA01 Eli Lilly and Company Limited,<br />

Basingstoke<br />

Velika<br />

Britanija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1633


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

KEFLEX cefaleksin 28×500mg J01DA01 Eli Lilly and Company Limited,<br />

Basingstoke<br />

KEFLEX cefaleksin 28×250mg J01DA01 Eli Lilly and Company Limited,<br />

Basingstoke<br />

KEFZOL inj. 2g cefazolin 1 steklenička po 2g J01DA04 Eli Lilly Italia S.p.A., Sesto Fiorentino, Italija<br />

KEFZOL inj. 1g cefazolin 1 steklenička po 1g J01DA04 Eli Lilly Italia S.p.A., Sesto Fiorentino, Italija<br />

KLIMICIN V vaginalna krema 2% klindamicin tuba po 40 g kreme in 7 aplikatorjev G01AA10 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

KLOMIFEN klomifen 10×50mg G03GB02 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

KORNAM tablete 2 mg terazosin 20 × 2 mg G04CA03 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

KORNAM tablete 5 mg terazosin 20 × 5 mg G04CA03 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

KORNAM tablete 1 mg terazosin 20 × 1 mg G04CA03 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

KRYPTOCUR gonadorelin 1 steklenička po 10 g vodne raztopine<br />

(20 mg/10 g) + 1 dozirna črpalka<br />

H01CA01 Hoechst AG, Frankfurt, Nemčija<br />

LANITOP metildigoksin 50 tablet po 0,1mg C01AA08 Pliva d.d., Zagreb Hrvaška<br />

LANZUL lansoprazol 14 × 30 mg A02BC03 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

Slovenija<br />

LARIAM meflokin 8×250mg P01BA05 F. Hoffmann-La Roche Ltd., Basel Švica<br />

LARTAN tablete 50 mg losartan 20 × 50 mg C09CA01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

LASIX 20 mg ampule furosemid zlozˇenka s 50 ampulami po 2 ml raztopine C03CA01 Hoechst Marion Roussel Deutschland Nemčija / Hoechst Avstrija<br />

GmbH, Frankfurt,<br />

Marion Roussel<br />

GmbH, Dunaj<br />

LASIX 20 mg ampule furosemid zlozˇenka s 5 ampulami po 2 ml raztopine C03CA01 Hoechst Marion Roussel Deutschland<br />

GmbH, Frankfurt,<br />

LASIX 40 mg tablete furosemid zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

C03CA01 Usiphar, Groupe Hoechst Marion<br />

Roussel, Francija<br />

LASIX 40 mg tablete furosemid zlozˇenka s 50 tabletami C03CA01 Usiphar, Groupe Hoechst Marion<br />

Roussel, Francija<br />

Nemčija / Hoechst<br />

Marion Roussel<br />

GmbH, Dunaj<br />

za Hoechst Marion<br />

Roussel GmbH,<br />

Dunaj, Avstrija<br />

za Hoechst Marion<br />

Roussel GmbH,<br />

Dunaj, Avstrija<br />

LESCOL 20 mg fluvastatin 28 × 20 mg C10AA04 Novartis Pharma AG, Basel Švica<br />

LESCOL 40 mg fluvastatin 28 × 40 mg C10AA04 Novartis Pharma AG, Basel Švica<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Avstrija<br />

1634 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

LEUCOMAX 150 µg molgramostim steklenička z liofiliziranim praškom 150 µg<br />

in ampula po 1 ml vode za injekcije<br />

LEUCOMAX 400 µg molgramostim steklenička z liofiliziranim praškom 400 µg<br />

in ampula po 1 ml vode za injekcije<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

L03AA03 Novartis Pharma AG v sodelovanju z<br />

Essex Chemie<br />

L03AA03 Novartis Pharma AG v sodelovanju z<br />

Essex Chemie<br />

LEUCOVORIN kalcijev folinat 50×15mg V03AF03 Cyanamid International Corporation<br />

Limited,<br />

LEUCOVORIN kalcijev folinat 10×15mg V03AF03 Cyanamid International Corporation<br />

Limited,<br />

LEUCOVORIN 10 kalcijev folinat ampula 10mg/ml V03AF03 Cyanamid International Corporation<br />

Limited,<br />

LEUCOVORIN 30 kalcijev folinat ampula 30mg/3ml V03AF03 Cyanamid International Corporation<br />

Limited,<br />

LEUCOVORIN 300 kalcijev folinat steklenička 300mg/30ml V03AF03 Cyanamid International Corporation<br />

Limited,<br />

LEUCOVORIN 50 kalcijev folinat ampula 50mg/5ml V03AF03 Cyanamid International Corporation<br />

Limited,<br />

Ltd, Luzern,Švica Švica<br />

Ltd, Luzern,Švica Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

LEXILIUM 1,5 mg bromazepam 30 × 1,5 mg N05BA08 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

LEXILIUM 3 mg bromazepam 30 × 3 mg N05BA08 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

LEXILIUM 6 mg bromazepam 30 × 6 mg N05BA08 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

LIDOCAIN HYDROCHLORID lidokain 100 ampul po 2 ml (40mg/2ml) N01BB02 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

LIPOFUNDIN MCT/LCT 10% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

LIPOFUNDIN MCT/LCT 10% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

LIPOFUNDIN MCT/LCT 10% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

steklenica 1×500ml emulzije B05BA02 B. Braun Melsungen AG, Melsungen Nemčija<br />

steklenička 1×250ml emulzije B05BA02 B. Braun Melsungen AG, Melsungen Nemčija<br />

steklenička 1×100ml emulzije B05BA02 B. Braun Melsungen AG, Melsungen Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1635


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

LIPOFUNDIN MCT/LCT 20% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

LIPOFUNDIN MCT/LCT 20% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

LIPOFUNDIN MCT/LCT 20% (maščobne<br />

emulzije za<br />

parenteralno<br />

prehrano)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

steklenica 1×500ml emulzije B05BA02 B. Braun Melsungen AG, Melsungen Nemčija<br />

steklenička 1×100ml emulzije B05BA02 B. Braun Melsungen AG, Melsungen Nemčija<br />

steklenička 1×250ml emulzije B05BA02 B. Braun Melsungen AG, Melsungen Nemčija<br />

LITALIR hidroksikarbamid 100 × 500mg L01XX05 Bristol-Myers Squibb Products S.A. Švica<br />

LITIJ KARBONAT litij 100×300mg N05AN01 Jadran, Galenski laboratorij d.d.,<br />

Rijeka, Hrvaška<br />

LODRONAT klodronska kislina 5 ampul po 10 ml (30 mg/ml) M05BA02 F. Hoffmann-La Roche Ltd., Basel Švica<br />

LODRONAT klodronska kislina 60 × 400 mg M05BA02 F. Hoffmann-La Roche Ltd., Basel Švica<br />

LORSILAN lorazepam 100 × 1mg N05BA06 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LORSILAN lorazepam 100 × 2,5mg N05BA06 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LORSILAN lorazepam 30×1mg N05BA06 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LORSILAN lorazepam 20 × 2,5mg N05BA06 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUBOR piroksikam 20 × 10 mg M01AC01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUBOR piroksikam 5 ampul × 40 mg/2ml M01AC01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUBOR piroksikam tuba 50 g (1%) M02AA07 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUBOR piroksikam 20 × 20 mg M01AC01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUBOR piroksikam 10 svečk po 20 mg M01AC01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUPOCET paracetamol 100 kapsul po 300 mg N02BE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUPOCET paracetamol 20 kapsul po 300 mg N02BE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

1636 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

LUPOCET paracetamol 10 tablet po 500 mg N02BE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUPOCET paracetamol 500 tablet po 120 mg N02BE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUPOCET paracetamol 500 tablet po 500 mg N02BE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUPOCET paracetamol 20 tablet po 120 mg N02BE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUPOCET paracetamol 10 svečk po 120 mg N02BE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUPOCET paracetamol 10 kapsul po 300 mg N02BE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LUPOCET paracetamol steklenička po 100 ml sirupa N02BE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

LYOGEN flufenazin 10 tablet po 6 mg N05AB02 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

LYOGEN flufenazin 10 tablet po 3 mg N05AB02 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

MACROPEN suspenzija midekamicin 1 steklenička s praškom za pripravo 115 ml<br />

suspenzije<br />

MAGNEVIST gadopentetna<br />

kislina<br />

MAGNEVIST gadopentetna<br />

kislina<br />

MAGNEVIST gadopentetna<br />

kislina<br />

MAGNEVIST gadopentetna<br />

kislina<br />

MAGNEVIST gadopentetna<br />

kislina<br />

MAGNEVIST gadopentetna<br />

kislina<br />

MAGNEVIST gadopentetna<br />

kislina<br />

MAGNEVIST gadopentetna<br />

kislina<br />

MAGNEVIST gadopentetna<br />

kislina<br />

J01FA03 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Konstanz Nemčija<br />

Konstanz Nemčija<br />

Slovenija<br />

steklenička po 30 ml (469,01 mg/ml) V08CA01 Schering AG, Berlin, Nemčija<br />

steklenička po 100 ml (469,01 mg/ml) V08CA01 Schering AG, Berlin, Nemčija<br />

5 vnaprej napolnjenih injekcijskih brizg po<br />

10 ml (469,01 mg/ml)<br />

5 vnaprej napolnjenih injekcijskih brizg po<br />

15 ml (469,01 mg/ml)<br />

5 vnaprej napolnjenih injekcijskih brizg po<br />

20 ml (469,01 mg/ml)<br />

V08CA01 Schering AG, Berlin, Nemčija<br />

V08CA01 Schering AG, Berlin, Nemčija<br />

V08CA01 Schering AG, Berlin, Nemčija<br />

steklenička 20 ml raztopine V08CA01 Schering AG, Berlin, Nemčija<br />

steklenička po 10 ml raztopine V08CA01 Schering AG, Berlin, Nemčija<br />

steklenička po 5 ml raztopine V08CA01 Schering AG, Berlin, Nemčija<br />

steklenička po 15 ml raztopine V08CA01 Schering AG, Berlin, Nemčija<br />

MAMOMIT aminoglutetimid 100 × 250mg L02BG01 Pliva d.d., Zagreb Hrvaška<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1637


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

MANDOL cefamandol 1 steklenička po 1g J01DA07 Lilly Deutchland GmbH, Giessen Nemčija<br />

MANDOL cefamandol 1 steklenička po 2g J01DA07 Lilly Deutchland GmbH, Giessen Nemčija<br />

MANDOL cefamandol 1 steklenička po 500 mg J01DA07 Lilly Deutchland GmbH, Giessen Nemčija<br />

MARCAINE 0,25% bupivakain injekcijske stekleničke 5×50mg/20ml N01BB01 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

Švedska<br />

MARCAINE 0,5% bupivakain injekcijske stekleničke 5×100mg/20ml N01BB01 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

Švedska<br />

MARCAINE ADRENALIN bupivakain injekcijske steklenizke 5×20ml(5mg/ml in N01BB51 ASTRA, Pharmaceutical production,<br />

Švedska<br />

5mcg/ml)<br />

Södertälje<br />

MARCAINE ADRENALIN bupivakain injekcijske steklenizke 5×20ml(2,5mg/ml in N01BB51 ASTRA, Pharmaceutical production,<br />

Švedska<br />

5mcg/ml)<br />

Södertälje<br />

MARCAINE SPINAL bupivakain ampule 5 × 4ml N01BB01 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

Švedska<br />

MARCAINE SPINAL 0,5% HEAVY bupivakain ampule 5×20mg/4ml N01BB01 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

Švedska<br />

MARIVARIN 3 mg varfarin 50 tablet po 3 mg B01AA03 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

Slovenija<br />

MARVELON desorgestrel 3×21 tablet G03AA09 N. V. Organon, Oss, Nizozemska<br />

MAXITROL neomicin tuba 3,5g S01CA01 ALCON Pharmaceuticals Ltd. Švica<br />

MAXITROL neomicin plastenka 5ml S01CA01 ALCON Pharmaceuticals Ltd. Švica<br />

MEDAZOL metronidazol 10 vaginalnih tablet G01AF01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

MEDAZOL metronidazol 20 tablet P01AB01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

MEDAZOL metronidazol steklenička po 100 ml raztopine (0,5%) J01XD01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

MEGACE megestrol 100×40mg L02AB01 Bristol-Myers Squibb Products S.A. Švica<br />

MEGACE megestrol 100×160mg L02AB01 Bristol-Myers Squibb Products S.A. Švica<br />

MENDIAXON 400 himekromon 20×400mg A05AX02 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

Konstanz Nemčija<br />

MESTINON piridostigmin 50 tablet po 10 mg N07AA02 F. Hoffmann-La Roche Ltd., Basel Švica<br />

MESTINON piridostigmin 150 oblozˇenih tablet po 60 mg N07AA02 F. Hoffmann-La Roche Ltd., Basel Švica<br />

METABLEN XE 0,25 % kapljice za timolol steklenička po 5 ml (2,5mg/1ml) S01ED01 LEK, tovarna farmacevtskih in<br />

d.d., Ljubljana Slovenija<br />

oko<br />

kemičnih izdelkov,<br />

METABLEN XE 0,25 %, kapljice za timolol steklenička po 2,5 ml (2,5mg/1ml) S01ED01 LEK, tovarna farmacevtskih in<br />

d.d., Ljubljana Slovenija<br />

oko<br />

kemičnih izdelkov,<br />

1638 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

METABLEN XE 0,5 % kapljice za oko timolol steklenička po 5 ml (5mg/1ml) S01ED01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

METABLEN XE 0,5 % kapljice za oko timolol steklenička po 2,5 ml (5mg/1ml) S01ED01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

METACIKLIN metaciklin 500 kapsul po 300 mg J01AA05 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

METACIKLIN metaciklin 1000 kapsul po 300 mg J01AA05 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

METACIKLIN metaciklin 8×300mg J01AA05 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

METACIKLIN metaciklin 100×300mg J01AA05 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

METHOTREXAT metotreksat 100 × 2,5mg L01BA01 Cyanamid International Corporation<br />

Limited,<br />

METHOTREXAT metotreksat 50 × 10mg L01BA01 Cyanamid International Corporation<br />

Limited,<br />

METHOTREXAT metotreksat 30 × 10mg L01BA01 Cyanamid International Corporation<br />

Limited,<br />

METHOTREXAT metotreksat 30 × 2,5mg L01BA01 Cyanamid International Corporation<br />

Limited,<br />

METHOTREXAT 1000 metotreksat prebodna steklenička po 40 ml raztopine L01BA01 Cyanamid International Corporation<br />

Limited,<br />

METHOTREXAT 25 metotreksat prebodna steklenička po 1 ml raztopine L01BA01 Cyanamid International Corporation<br />

Limited,<br />

METHOTREXAT 5 metotreksat prebodna steklenička po 2 ml raztopine L01BA01 Cyanamid International Corporation<br />

Limited,<br />

METHOTREXAT 50 metotreksat prebodna steklenička po 2 ml raztopine L01BA01 Cyanamid International Corporation<br />

Limited,<br />

METHOTREXAT 500 metotreksat prebodna steklenička po 20 ml raztopine L01BA01 Cyanamid International Corporation<br />

Limited,<br />

METHOTREXAT 5000 metotreksat prebodna steklenička po 200 ml raztopine L01BA01 Cyanamid International Corporation<br />

Limited,<br />

METRODIN HP urofolitropin 10 ampul po 75 I.E. in 10 × 1ml fiziološke<br />

raztopine<br />

METRODIN HP urofolitropin 1 ampula po 75 I.E. in 1×1ml fiziološke<br />

raztopine<br />

G03GA04 Pharma Serono Lab S.A. Chateau de<br />

Vaumarcus,<br />

G03GA04 Pharma Serono Lab S.A. Chateau de<br />

Vaumarcus,<br />

MEXITIL injekcije meksiletin 5 ampul po 10 ml (250 mg/10 ml) C01BB02 Boehringer Ingelheim International<br />

GmbH,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Zurich Švica<br />

Ingelheim am<br />

Rhein<br />

Švica<br />

Švica<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1639


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

MIACALCIC pršilo za nos, 100 I.E. sintezni<br />

kalcitonin lososa<br />

MIACALCIC raztopina za injiciranje sintezni<br />

kalcitonin lososa<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

škatla s stekleničko (z nosnikom) po 2 ml<br />

raztopine (1100 I. E./ml)<br />

H05BA01 Novartis Pharma S.A., Huningue,<br />

Francija za<br />

Novartis Pharma<br />

AG, Basel, Švica<br />

5 ampul po 1 ml (100 I. E./ml) H05BA01 Novartis Pharma AG, Basel Švica<br />

MORPHINI CHLORIDUM morfin 10 ampul po1 ml raztopine (20mg/1ml) N02AA01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

MYDRIACYL 0,5% tropikamid plastenka po 15 ml raztopine (0,5%) S01FA06 ALCON Pharmaceuticals Ltd. Švica<br />

MYDRIACYL 1% tropikamid plastenka po 15 ml raztopine (1%) S01FA06 ALCON Pharmaceuticals Ltd. Švica<br />

NAFAZOLIN nafazolin steklenička po 10 ml raztopine (1mg/1ml) R01AA08 Jadran, Galenski laboratorij d.d.,<br />

Rijeka, Hrvaška<br />

NAFAZOLIN nafazolin steklenička po 10 ml raztopine (0,5mg/1ml) R01AA08 Jadran, Galenski laboratorij d.d.,<br />

Rijeka, Hrvaška<br />

NAVOBAN tropisetron ampula 1×5mg/5ml A04AA03 Novartis Pharma AG, Basel Švica<br />

NEBCIN inj. 20mg/2ml tobramicin zlozˇenka s stekleničko po 2 ml raztopine<br />

(20mg/2ml)<br />

J01GB01 Lilly France S.A., Fegersheim Francija<br />

NEBCIN inj. 80 mg/2ml tobramicin zlozˇenka s stekleničko po 2 ml raztopine<br />

(80mg/2ml)<br />

J01GB01 Lilly France S.A., Fegersheim Francija<br />

NEBCIN inj. 40 mg/ml tobramicin zlozˇenka s stekleničko po 1 ml raztopine<br />

(40mg/ml)<br />

J01GB01 Lilly France S.A., Fegersheim Francija<br />

NEUPOGEN injekcije filgrastim 5 ampul po 1,6 ml L03AA02 F. Hoffmann-La Roche Ltd., Basel Švica<br />

NEUPOGEN injekcije filgrastim 5 ampul po 1 ml raztopine L03AA02 F. Hoffmann-La Roche Ltd., Basel Švica<br />

NIFECARD XL tablete 30 mg nifedipin 30 × 30 mg C08CA05 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

NIFECARD XL tablete 30 mg nifedipin 20 × 30 mg C08CA05 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

NIFECARD XL tablete 60 mg nifedipin 30 × 60 mg C08CA05 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

NIFECARD XL tablete 30 mg nifedipin 100 × 30 mg C08CA05 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

NIFECARD XL tablete 60 mg nifedipin 400 × 60 mg C08CA05 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

NIFECARD XL tablete 60 mg nifedipin 100 × 60 mg C08CA05 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

NIFECARD XL tablete 60 mg nifedipin 20 × 60 mg C08CA05 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

NISTATIN nistatin steklenička s praškom za pripravo<br />

suspenzije, dodati 23 ml destilirane vode<br />

A07AA02 Pliva d.d., Zagreb Hrvaška<br />

NISTATIN nistatin tuba po 20 g mazila D01AA01 Pliva d.d., Zagreb Hrvaška<br />

1640 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

NITRODERM TTS 10 gliceriltrinitrat 10 oblizˇev velikosti 20 cm × cm<br />

(50 mg/oblizˇ)<br />

C01DA02 Novartis Pharma AG, Basel Švica<br />

NITROLINGUAL pršilo gliceriltrinitrat pršilka po 12,2 ml C01DA02 G. POHL-BOSKAMP GmbH & Co.,<br />

Hohenlockstedt<br />

Nemčija<br />

NOVANTRONE mitoksantron steklenička 30 mg/15ml L01DB07 Cyanamid International Corporation<br />

Limited,<br />

Zurich Švica<br />

NOVANTRONE mitoksantron steklenička 25mg/12,5ml L01DB07 Cyanamid International Corporation<br />

Limited,<br />

Zurich Švica<br />

NOVANTRONE mitoksantron steklenička 20 mg/10ml L01DB07 Cyanamid International Corporation<br />

Limited,<br />

Zurich Švica<br />

OKSAZEPAM oksazepam 30 × 10 mg N05BA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

OKSAZEPAM oksazepam 25×10mg N05BA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

OKSITETRACIKLIN oksitetraciklin 100×250mg J01AA06 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

OKSITETRACIKLIN oksitetraciklin 16×250mg J01AA06 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

OLFEN 100 RECTOCAPS diklofenak 5×100mg M01AB05 MEPHA Ltd., Aesch, Basel Švica<br />

OLFEN 25 LACTAB diklofenak 30×25mg M01AB05 MEPHA Ltd., Aesch, Basel Švica<br />

OLFEN 50 LACTAB diklofenak 20×50mg M01AB05 MEPHA Ltd., Aesch, Basel Švica<br />

OLFEN 50 RECTOCAPS diklofenak 10×50mg M01AB05 MEPHA Ltd., Aesch, Basel Švica<br />

OLFEN 75 AMPULE diklofenak ampule 5×2ml M01AB05 MEPHA Ltd., Aesch, Basel Švica<br />

OLFEN GEL diklofenak tuba 20g M02AA15 MEPHA Ltd., Aesch, Basel Švica<br />

OLFEN GEL diklofenak tuba 50g M02AA15 MEPHA Ltd., Aesch, Basel Švica<br />

OLICARD 40 RETARD izosorbidmononitrat<br />

OLICARD 60 RETARD izosorbidmononitrat<br />

50 × 40 mg C01DA14 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

50 × 60 mg C01DA14 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

OLICEF prašek za injekcijo 500 mg ceftriakson 10 stekleničk po 500 mg J01DA13 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

OLICEF prašek za injekcijo 500 mg ceftriakson 50 stekleničk po 500 mg J01DA13 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

OLICEF prašek za injekcijo 500 mg ceftriakson 5 stekleničk po 500 mg J01DA13 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

OPTIRAY 160 joversol steklenička po 50 ml raztopine V08AB07 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

Hrvaška<br />

Hrvaška<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Konstanz Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1641


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

OPTIRAY 240 joversol steklenička po 50 ml raztopine V08AB07 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

Konstanz Nemčija<br />

OPTIRAY 320 joversol steklenička po 50 ml raztopine V08AB07 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

Konstanz Nemčija<br />

ORGAMETRIL linestrenol 30 × 5 mg G03DC03 N. V. Organon, Oss, Nizozemska<br />

ORMIDOL atenolol 14×100mg C07AB03 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

ORMIDOL atenolol 28×100mg C07AB03 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

ORONAZOL šampon ketokonazol steklenička po 100 ml zdravilnega šampona<br />

(20mg/1g)<br />

D01AC08 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

ORONAZOL krema ketokonazol tuba po 30 g kreme (20mg/1g) D01AC08 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

Slovenija<br />

ORTANOL kapsule 20 mg omeprazol 14 × 20 mg A02BC01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

ORTANOL kapsule 20 mg omeprazol zlozˇenka s stekleničko z 28 kapsulami A02BC01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

ORTANOL kapsule 20 mg omeprazol zlozˇenka s stekleničko s 7 kapsulami A02BC01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

ORTANOL tablete 20 mg omeprazol 14 × 20 mg A02BC01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

ORTHO-GYNEST estriol tuba 80 g vaginalne kreme 0,01% G03CA04 Cilag AG, Schaffhausen, Švica<br />

ORTHO-GYNEST D estriol 6 vaginalnih tablet po 3,5 mg G03CA04 Cilag AG, Schaffhausen, Švica<br />

PANADON sirup paracetamol steklenička po 100 ml sirupa (120mg/5ml) N02BE01 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

Slovenija<br />

PANADON tablete paracetamol 500 × 500 mg N02BE01 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

Slovenija<br />

PANZYNORM FORTE multiencimski<br />

pripravki (lipaze,<br />

proteaze)<br />

30 oblozˇenih tablet A09AA02 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

PARACETAMOL paracetamol steklenička 150ml (120mg/5ml) N02BE01 Jadran, Galenski laboratorij d.d.,<br />

Rijeka, Hrvaška<br />

PARAPLATIN karboplatin 1 steklenička 450mg/45ml L01XA02 Bristol-Myers Squibb Products S.A. Švica<br />

PARAPLATIN karboplatin 1 steklenička 150mg/15ml L01XA02 Bristol-Myers Squibb Products S.A. Švica<br />

PENACTAM injekcije 750 mg ampicilin 1 steklenička (500 mg + 250 mg) J01CR01 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

Slovenija<br />

PENACTAM injekcije 1,5 g ampicilin 1 steklenička (1000 mg + 500 mg) J01CR01 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

1642 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

PENTILIN FORTE pentoksifilin 20 × 600 mg C04AD03 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

PENTILIN FORTE pentoksifilin 100 × 600 mg C04AD03 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

PENTILIN injekcije 300mg/15ml pentoksifilin 10 ampul po 15 ml raztopine<br />

(300 mg/15ml)<br />

C04AD03 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

PENTILIN tablete pentoksifilin 20 × 400 mg C04AD03 KRKA, tovarna zdravil, d.d., Novo<br />

mesto,<br />

PERGONAL 75 menotropinhumani<br />

menopavzni<br />

gonadotropin<br />

10 prebodnih stekleničk po 75 I.E. FSH in<br />

75 I.E. LH in 10 ampul po 1 ml izotonične<br />

raztopine natrijevega klorida<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

Slovenija<br />

G03GA02 Laboratoires Serono SA Švica<br />

PILOGEL HS pilokarpin tuba po 5 g gela (4%) S01EB01 ALCON Pharmaceuticals Ltd. Švica<br />

PILOKARPIN 1% pilokarpin steklenička po 10 ml 1% raztopine S01EB01 Pliva d.d., Zagreb Hrvaška<br />

PILOKARPIN 2% pilokarpin steklenička po 10 ml 2% raztopine S01EB01 Pliva d.d., Zagreb Hrvaška<br />

PKU 1 hranila brez<br />

vsebnosti<br />

fenilalanina<br />

PKU 2 hranila brez<br />

vsebnosti<br />

fenilalanina<br />

PKU 3 hranila brez<br />

vsebnosti<br />

fenilalanina<br />

pločevinka po 500 g praška V06CA Milupa GmbH & Co.K.G.,<br />

Friedrichsdorf,<br />

pločevinka po 500 g praška V06CA Milupa GmbH & Co.K.G.,<br />

Friedrichsdorf,<br />

pločevinka po 500 g praška V06CA Milupa GmbH & Co.K.G.,<br />

Friedrichsdorf,<br />

PLATAMINE cisplatin 1 steklenička po 50 mg cisplatina L01XA01 Pharmacia/Farmitalia Carlo Erba s.r.l.,<br />

Milano<br />

PLATAMINE cisplatin 1 steklenička po 10 mg cisplatina L01XA01 Pharmacia/Farmitalia Carlo Erba s.r.l.,<br />

Milano<br />

PLIVIT A retinol<br />

(vitamin A)<br />

Nemčija<br />

Nemčija<br />

Nemčija<br />

steklenička po 10 ml raztopine A11CA01 Pliva d.d., Zagreb Hrvaška<br />

Italija<br />

Italija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1643


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

PLIVIT C askorbinska<br />

kislina<br />

(vitamin C)<br />

PLIVIT C askorbinska<br />

kislina<br />

(vitamin C)<br />

POROLEN tablete 10 mg alendronska<br />

kislina<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

ampule 50×500mg/5ml A11GA01 Pliva d.d., Zagreb Hrvaška<br />

250×500mg (posamezno pakiranje po 10<br />

tablet)<br />

A11GA01 Pliva d.d., Zagreb Hrvaška<br />

28 × 10 mg M05BA04 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

PRE-PAR RETARD ritodrin 60 × 40 mg G02CA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

PRE-PAR RETARD ritodrin 30 × 40 mg G02CA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

PROFASI 5000 I.E. humani horionski<br />

gonadotropin<br />

10 prebodnih stekleničk po 5000 I.E. +<br />

10 ampul po 1 ml fiziološke raztopine<br />

PROSTIDE finasterid zlozˇenka z 28 tabletami po 5 mg (2 × 14<br />

tablet v pretisnem omotu)<br />

PROSTIN VR alprostadil zlozˇenka s 5 ampulami po 1 ml koncentrata<br />

(0,5 mg/ml)<br />

PROTHROMPLEX TOTAL TIM 4 kombinacije<br />

koagulacijskih<br />

faktorjev IX, II,<br />

VII in X<br />

PROTHROMPLEX TOTAL TIM 4 kombinacije<br />

koagulacijskih<br />

faktorjev IX, II,<br />

VII in X<br />

PROVERA medroksiprogesteron<br />

steklenička 1×600I.E. in steklenička 1×20ml<br />

vode za inekcije<br />

steklenička 1×200I.E. in steklenička 1×20ml<br />

vode za injekcije<br />

d.d., Ljubljana Slovenija<br />

Hrvaška<br />

Hrvaška<br />

G03GA01 Laboratoires Serono SA Švica<br />

G04CB01 MERCK SHARP & DOHME BV<br />

Nizozemska za<br />

C01EA01 Pharmacia & Upjohn N.V./S.A., Puurs,<br />

Belgija<br />

MERCK SHARP &<br />

DOHME IDEA,<br />

INC., Švica<br />

za Pharmacio &<br />

Upjohn S.A.,<br />

Luxemburg<br />

Immuno AG, Dunaj, Avstrija<br />

Immuno AG, Dunaj, Avstrija<br />

40 tablet po 250 mg L02AB02 Upjohn s.a., West Sussex Velika<br />

Britanija<br />

PROZAC fluoksetin 1 steklenička po 70 ml raztopine<br />

(20mg/5ml)<br />

N06AB03 Lilly S.A., Alcobendas, Madrid Španija<br />

QUINAX dihidroazapentacen<br />

1 steklenička po 15 ml 0,015% raztopine S01XA ALCON Pharmaceuticals Ltd. Švica<br />

RABIPUR cepivo proti<br />

steklini z<br />

inaktiviranimi<br />

virusi<br />

RAZTOPINA 0,9 % NATRIJEVEGA<br />

KLORIDA za hemodializo<br />

zlozˇenka s 5 ampulami po 1 ml raztopine<br />

(2,5 I.E./ml), 5 ampul po 1 ml vode za<br />

injekcije in 5 injekcijskih brizg<br />

natrijev klorid plastična vrečka po 2000 ml raztopine<br />

(9g/1000ml)<br />

J07BG01 Chiron Behring GmbH & Co.,<br />

Marburg<br />

Nemčija<br />

B05CB01 Baxter Export Corporation, Miami, ZDA<br />

REGLAN tablete metoklopramid 40 × 10 mg A03FA01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

1644 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

REGLAN injekcije metoklopramid 30 ampul po 2 ml (10mg/2ml) A03FA01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

REGLAN peroralna raztopina metoklopramid steklenička po 120 ml raztopine (5mg/5ml) A03FA01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

RENICIN tablete 300 mg roksitromicin 10 tablet po 300 mg J01FA06 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

RENICIN tablete 300 mg roksitromicin 7 tablet po 300 mg J01FA06 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

RETROVIR zidovudin 100×100mg J05AB05 Glaxo Wellcome Operations,<br />

Greenford<br />

RINGERJEVA RAZTOPINA elektroliti infuzijska steklenica 1×500ml B05XA30 Pliva d.d., Zagreb Hrvaška<br />

ROCEPHIN injekcije ceftriakson 5 stekleničk po 250 mg ceftriaksona in<br />

5 ampul po 5 ml vode za injekcije<br />

J01DA13 F. Hoffmann-La Roche Ltd., Basel Švica<br />

ROCEPHIN injekcije ceftriakson 143 stekleničk po 1 g ceftriaksona in<br />

143 ampul po 10 ml vode za injekcije<br />

J01DA13 F. Hoffmann-La Roche Ltd., Basel Švica<br />

ROCEPHIN injekcije ceftriakson 5 stekleničk po 1 g ceftriaksona in 5 ampul<br />

po 10 ml vode za injekcije<br />

J01DA13 F. Hoffmann-La Roche Ltd., Basel Švica<br />

ROCEPHIN injekcije ceftriakson 143 stekleničk po 250 mg ceftriaksona in<br />

143 ampul po 5 ml vode za injekcije<br />

J01DA13 F. Hoffmann-La Roche Ltd., Basel Švica<br />

ROCEPHIN injekcije ceftriakson 143 stekleničk po 1 g ceftriaksona in 143<br />

ampul po 3,5 ml raztopine lidokaina (1%)<br />

J01DA63 F. Hoffmann-La Roche Ltd., Basel Švica<br />

ROCEPHIN injekcije ceftriakson 5 stekleničk po 1 g ceftriaksona in<br />

5 ampul po 3,5 ml raztopine lidokaina<br />

(1 % )<br />

J01DA63 F. Hoffmann-La Roche Ltd., Basel Švica<br />

ROCEPHIN injekcije ceftriakson 143 stekleničk po 250 mg ceftriaksona in<br />

143 ampul po 2 ml raztopine lidokaina (1%)<br />

J01DA63 F. Hoffmann-La Roche Ltd., Basel Švica<br />

ROCEPHIN injekcije ceftriakson 5 stekleničk po 250 mg ceftriaksona in 5<br />

ampul po 2 ml raztopine lidokaina (1% )<br />

J01DA63 F. Hoffmann-La Roche Ltd., Basel Švica<br />

RUDAKOL mebeverin 50×135mg A03AA04 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

RUPURUT suspenzija hidrotalcit 20 vrečk po 10 ml suspenzije<br />

(1000mg/10ml)<br />

A02AD04 Bayer Pharma d.o.o. Slovenija<br />

RUPURUT tablete hidrotalcit 50 × 500 mg A02AD04 Bayer Pharma d.o.o. Slovenija<br />

RUPURUT tablete hidrotalcit 20 × 500 mg A02AD04 Bayer Pharma d.o.o. Slovenija<br />

SABRIL vigabatrin zlozˇenka s 100 tabletami po 500 mg<br />

(10 × 10 tablet v pretisnem omotu)<br />

N03AG04 Marion Merrel Bourgoin S.A.<br />

Bourgoin — Jallieu,<br />

Francija za Hoechst<br />

Marion Roussel<br />

GmbH, Dunaj<br />

SALVIAMIN L8B.UH aminokisline infuzijska steklenica po 500 ml raztopine B05BA01 Pliva d.d., Zagreb Hrvaška<br />

Velika<br />

Britanija<br />

Avstrija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1645


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

SALVIAMIN LX6 aminokisline infuzijska steklenica po 500 ml raztopine B05BA10 Pliva d.d., Zagreb Hrvaška<br />

SANDIMMUN koncentrat za pripravo<br />

raztopine za intravensko infudiranje<br />

50 mg<br />

SANDIMMUN koncentrat za pripravo<br />

raztopine za intravensko infundiranje<br />

250 mg<br />

SANDIMMUN NEORAL kapsule<br />

25 mg<br />

SANDIMMUN NEORAL kapsule<br />

100 mg<br />

SANDIMMUN NEORAL kapsule<br />

50 mg<br />

SANDIMMUN NEORAL raztopina za<br />

peroralno uporabo<br />

ciklosporin 10 ampul po 1 ml (50 mg/ml) L04AA01 Novartis Pharma AG, Basel Švica<br />

ciklosporin 10 ampul po 5 ml (250 mg/5 ml) L04AA01 Novartis Pharma AG, Basel Švica<br />

ciklosporin 50 × 25 mg L04AA01 Novartis Pharma AG, Basel Švica<br />

ciklosporin 50 × 100 mg L04AA01 Novartis Pharma AG, Basel Švica<br />

ciklosporin 50 × 50 mg L04AA01 Novartis Pharma AG, Basel Švica<br />

ciklosporin steklenička po 50 ml (100 mg/ml) L04AA01 Novartis Pharma AG, Basel Švica<br />

SANDOSTATIN 0,05 mg oktreotid 5 ampul po 1 ml (0,05 mg/ml) H01CB02 Novartis Pharma AG, Basel Švica<br />

SANDOSTATIN 0,1 mg oktreotid 5 ampul po 1ml (0,1 mg/ml) H01CB02 Novartis Pharma AG, Basel Švica<br />

SANDOSTATIN 0,5 mg oktreotid 5 ampul po 1 ml (0,5 mg/ml) H01CB02 Novartis Pharma AG, Basel Švica<br />

SANVAL tablete 5 mg zolpidem 20 × 5 mg N05CF02 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

SANVAL tablete 10 mg zolpidem 20 × 10 mg N05CF02 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

SANVAL tablete 10 mg zolpidem 10 × 10 mg N05CG01 LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

SELECTOL celiprolol 20 × 200 mg C07AB08 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

SEREVENT Diskus salmeterol zlozˇenka z diskom s praškom za inhaliranje<br />

(za 60 odmerkov)<br />

SILAPEN 1000 benzatinijev<br />

fenoksimetilpenicilinat<br />

SILAPEN 1500 benzatinijev<br />

fenoksimetilpenicilinat<br />

steklenica po 150 ml sirupa<br />

(1.000.000 I.E./7ml)<br />

R03AC12 Glaxo Wellcome Production, Evreux,<br />

Francija za<br />

J01CE10 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

30 tablet po 1.500.000 I.E. J01CE10 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Glaxo Wellcome<br />

Export Ltd., Velika<br />

Britanija<br />

SINECOD butamirat steklenička po 200ml sirupa (1,5mg/ml) R05DB13 ZYMA S.A., Nyon, Švica<br />

SINEQUAN 10 mg doksepin 30 × 10 mg N06AA12 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

Hrvaška<br />

Hrvaška<br />

1646 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

SINEQUAN 25 mg doksepin 30 × 25 mg N06AA12 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

SIRDALUD 2 mg tizanidin 30 × 2 mg M03BX02 Novartis Pharma AG, Basel Švica<br />

SIRDALUD 4 mg tizanidin 30 × 4 mg M03BX02 Novartis Pharma AG, Basel Švica<br />

SIRDALUD 6 mg tizanidin 30 × 6 mg M03BX02 Novartis Pharma AG, Basel Švica<br />

SORBISTERIT polistirensulfonat lonček po 500 g praška V03AE01 Leopold Pharma GmbH, Graz, Avstrija<br />

SOVENTOL gel bamipin tuba po 20 g gela D04AA15 Knoll AG, Ludwigshafen, Nemčija<br />

STILAMIN somatostatin ampula 1×3 mg in ampula po 1 ml vode za<br />

injekcije<br />

SULOTRIM sulfametoksazol<br />

in trimetoprim<br />

SULOTRIM sulfametoksazol<br />

in trimetoprim<br />

SULOTRIM sulfametoksazol<br />

in trimetoprim<br />

SULOTRIM sulfametoksazol<br />

in trimetoprim<br />

SULOTRIM sulfametoksazol<br />

in trimetoprim<br />

SULOTRIM sulfametoksazol<br />

in trimetoprim<br />

SULOTRIM sulfametoksazol<br />

in trimetoprim<br />

H01CB01 Pharma Serono Lab S.A. Chateau de<br />

Vaumarcus,<br />

20 tablet J01EE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

100 tablet J01EE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

100 tablet J01EE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

steklenička po 100 ml sirupa J01EE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

1000 tablet J01EE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

20 tablet J01EE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

500 tablet J01EE01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

SUMAMED azitromicin 3 tablet po 500 mg J01FA10 Pliva d.d., Zagreb Hrvaška<br />

SUMAMED azitromicin 6 tablet po 125 mg J01FA10 Pliva d.d., Zagreb Hrvaška<br />

SUMAMED azitromicin steklenička s praškom za pripravo 20 ml<br />

suspenzije , dodati 12 ml destilirane vode<br />

J01FA10 Pliva d.d., Zagreb Hrvaška<br />

SUMAMED azitromicin 6 kapsul po 250 mg J01FA10 Pliva d.d., Zagreb Hrvaška<br />

SUMAMED FORTE azitromicin steklenička s praškom za pripravo 20 ml<br />

suspenzije , dodati 12 ml destilirane vode<br />

SUPRARENIN adrenalin<br />

(epinefrin)<br />

zlozˇenka z 10 ampulami po 1 ml raztopine<br />

(1 mg/ml)<br />

Švica<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

Hrvaška<br />

J01FA10 Pliva d.d., Zagreb Hrvaška<br />

C01CA24 Hoechst Marion Roussel Deutschland<br />

GmbH,Frankfurt,<br />

Nemčija / Hoechst<br />

Marion Roussel<br />

GmbH, Dunaj<br />

SUPREMIN butamirat 1 steklenička po 200 ml (4mg/5ml) R05DB13 Pliva d.d., Zagreb Hrvaška<br />

SYNAREL nafarelin plastični vsebnik z nastavkom z odmernim<br />

ventilom (za 60 odmerkov-200 µg/odmerek)<br />

Avstrija<br />

H01CA02 Syntex Pharmaceutica AG, Allschwil, Švica<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1647


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

SYNTARIS flunizolid steklenička po 24 ml raztopine z nastavkom<br />

z odmernim ventilom (za 240 odmerkov<br />

-25 µg/odmerek)<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

R03BA03 Syntex Pharmaceutica AG, Allschwil, Švica<br />

SYNTEX MENOPHASE mestranol 28 tablet (5 roza, 8 oranzˇnih, 2 rumeni,<br />

3 zelene, 6 modrih in 4 sivo modre)<br />

G03FB05 Syntex Pharmaceutica AG, Allschwil, Švica<br />

SYNTOCINON Nasal Spray oksitocin steklenička po 5 ml (40 I. E./ml) H01BB02 Novartis Pharma AG, Basel Švica<br />

SYNTOCINON raztopina za<br />

injiciranje 10 I. E.<br />

oksitocin 100 ampul po 1 ml (10 I. E./ml) H01BB02 Novartis Pharma AG, Basel Švica<br />

SYNTOCINON raztopina za<br />

injiciranje 5 I. E.<br />

oksitocin 100 ampul po 1 ml (5 I. E./ml) H01BB02 Novartis Pharma AG, Basel Švica<br />

TARGOCID teikoplanin zlozˇenka z eno stekleničko po 400 mg<br />

teikoplanina in eno ampulo po 3,2 ml vode<br />

za injekcije<br />

TARGOCID teikoplanin zlozˇenka z eno stekleničko po 200 mg<br />

teikoplanina in eno ampulo po 3,2 ml vode<br />

za injekcije<br />

TAUREDON 10 natrijev<br />

avrotiomalat<br />

TAUREDON 20 natrijev<br />

avrotiomalat<br />

TAUREDON 50 natrijev<br />

avrotiomalat<br />

J01XA02 Gruppo Lepetit S.p.A., Anagni, Italija<br />

za Hoechst<br />

J01XA02 Gruppo Lepetit S.p.A., Anagni, Italija<br />

za Hoechst<br />

ampule 10×10mg/0,5ml M01CB01 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

ampule 10×20mg/0,5ml M01CB01 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

ampule 10×50mg/0,5ml M01CB01 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

Marion Roussel<br />

Deutschland<br />

GmbH, Frankfurt<br />

Marion Roussel<br />

Deutschland<br />

GmbH, Frankfurt<br />

Nemčija<br />

Nemčija<br />

Konstanz Nemčija<br />

Konstanz Nemčija<br />

Konstanz Nemčija<br />

TAVEGYL klemastin 5 ampul po 2 ml (2 mg/2 ml) R06AA04 Novartis Pharma AG, Basel Švica<br />

TAXILAN perazin ampule 10×50mg/2ml N05AB10 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

Konstanz Nemčija<br />

TAXILAN perazin 25×100mg N05AB10 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

Konstanz Nemčija<br />

TAXILAN perazin 20×100mg N05AB10 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

Konstanz Nemčija<br />

TAXILAN perazin 50 oblozˇenih tablet po 25 mg N05AB10 Byk Gulden Lomberg Chemische<br />

Fabrik GmbH,<br />

Konstanz Nemčija<br />

TEARS NATURALE dekstran zlozˇenka s plastenko (z zaporko s kapalko)<br />

po 15 ml raztopine<br />

S01XA20 ALCON Pharmaceuticals Ltd. Švica<br />

TERTENSIF indapamid zlozˇenka s 30 tabletami C03BA11 Les Laboratoires Servier Industrie,<br />

Gidy,<br />

Francija<br />

TIMOPTIC XE 0,25 % timolol zlozˇenka s stekleničko po 5 ml raztopine S01ED01 MERCK SHARP & DOHME,<br />

Pennsylvania,<br />

ZDA<br />

TIMOPTIC XE 0,5 % timolol zlozˇenka s stekleničko po 5 ml raztopine S01ED01 MERCK SHARP & DOHME,<br />

Pennsylvania,<br />

ZDA<br />

1648 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

TINIDIL izosorbiddinitrat 40 podjezičnih tablet po 5 mg C01DA08 Pliva d.d., Zagreb Hrvaška<br />

TOBREX tobramicin plastenka 5 ml raztopine (0,3%) S01AA12 ALCON Pharmaceuticals Ltd. Švica<br />

TOBREX tobramicin tuba po 3,5 g mazila za oko (0,3%) S01AA12 ALCON Pharmaceuticals Ltd. Švica<br />

TONOCARDIN doksazosin 20×4mg C02CA04 Pliva d.d., Zagreb Hrvaška<br />

TONOCARDIN doksazosin 20 × 2mg C02CA04 Pliva d.d., Zagreb Hrvaška<br />

TOPISOLON dezoksimetazon tuba po 50 g mazila (0,25%) D07AC03 Hoechst AG, Frankfurt, Nemčija<br />

TOPISOLON dezoksimetazon tuba po 15 g mazila (0,25%) D07AC03 Hoechst AG, Frankfurt, Nemčija<br />

TOPISOLON MITE dezoksimetazon tuba po 15 g mazila (0,05%) D07AC03 Hoechst AG, Frankfurt, Nemčija<br />

TOPISOLON MITE dezoksimetazon tuba po 50 g mazila (0,05%) D07AC03 Hoechst AG, Frankfurt, Nemčija<br />

TRACUTIL (kombinacije<br />

elektrolitov z<br />

drugimi<br />

pripravki)<br />

TRACUTIL (kombinacije<br />

elektrolitov z<br />

drugimi<br />

pripravki)<br />

5 ampul po 10 ml koncentrata B05XA31 B. Braun Melsungen AG, Melsungen Nemčija<br />

50 ampul po 10 ml koncentrata B05XA31 B. Braun Melsungen AG, Melsungen Nemčija<br />

TRAMAL RETARD 100 mg tramadol 30 × 100 mg N02AX02 Bayer Pharma d.o.o. Slovenija<br />

TRASICOR 80 oksprenolol 20 × 80mg C07AA02 Pliva d.d., Zagreb Hrvaška<br />

TRINOVUM noretisteron 3×21 tablet (7 belih, 7 rozˇnatih, 7 oranzˇnih) G03AB04 Cilag AG, Schaffhausen, Švica<br />

TRITACE 1,25 ramipril zlozˇenka z 28 tabletami C09AA05 Hoechst Marion Roussel S.p.A.,<br />

Scoppito, Italija<br />

TRITACE 2,5 ramipril zlozˇenka z 28 tabletami C09AA05 Hoechst Marion Roussel S.p.A.,<br />

Scoppito, Italija<br />

TRITACE 5 ramipril zlozˇenka z 28 tabletami C09AA05 Hoechst Marion Roussel S.p.A.,<br />

Scoppito, Italija<br />

za Hoechst Marion<br />

Roussel GmbH,<br />

Dunaj, Avstrija<br />

za Hoechst Marion<br />

Roussel GmbH,<br />

Dunaj, Avstrija<br />

za Hoechst Marion<br />

Roussel GmbH,<br />

Dunaj, Avstrija<br />

ULTRACAIN D-S FORTE artikain ampule 10 × 2ml N01BB58 Hoechst AG, Frankfurt, Nemčija<br />

URBASON 16 mg tablete metilprednizolon zlozˇenka s 30 tabletami H02AB04 Hoechst Marion Roussel S.p.A.,<br />

Scoppito, Italija<br />

URBASON 4 mg tablete metilprednizolon zlozˇenka z 20 tabletami (2 × 10 tablet v<br />

pretisnem omotu)<br />

H02AB04 Hoechst Marion Roussel S.p.A.,<br />

Scoppito, Italija<br />

za Hoechst Marion<br />

Roussel<br />

Deutschland GmbH<br />

za Hoechst Marion<br />

Roussel GmbH,<br />

Dunaj, Avstrija<br />

Nemčija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1649


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

URBASON 40 mg tablete metilprednizolon zlozˇenka s 50 tabletami H02AB04 Hoechst Marion Roussel S.p.A.,<br />

Scoppito, Italija<br />

URBASON SOLUBILE 16 metilprednizolon zlozˇenka s 3 prebodnimi stekleničkami s<br />

praškom in 3 ampulami po 1 ml vode za<br />

injekcije<br />

URBASON SOLUBILE 32 metilprednizolon zlozˇenka s 3 prebodnimi stekleničkami s<br />

praškom in 3 ampulami po 1 ml vode za<br />

injekcije<br />

URBASON SOLUBILE FORTE 1000 metilprednizolon zlozˇenka z eno prebodno stekleničko s<br />

1000 mg metilprednizolona in 1 ampulo po<br />

10 ml vode za injekcije<br />

URBASON SOLUBILE FORTE 250 metilprednizolon zlozˇenka s 5 prebodnimi stekleničkami s<br />

praškom in 5 ampulami po 5 ml vode za<br />

injekcije<br />

URSOSAN ursodeoksiholna<br />

kislina<br />

H02AB04 Hoechst Marion Roussel, SA, Sant<br />

Feliu de Llobregat,<br />

H02AB04 Hoechst Marion Roussel, SA, Sant<br />

Feliu de Llobregat,<br />

H02AB04 Hoechst Marion Roussel Deutschland<br />

GmbH, Frankfurt,<br />

H02AB04 Hoechst Marion Roussel, SA, Sant<br />

Feliu de Llobregat,<br />

za Hoechst Marion<br />

Roussel GmbH,<br />

Dunaj, Avstrija<br />

Španija, za Hoechst<br />

Marion Roussel<br />

GmbH, Dunaj<br />

Španija, za Hoechst<br />

Marion Roussel<br />

GmbH, Dunaj<br />

Nemčija / Hoechst<br />

Marion Roussel<br />

GmbH, Dunaj<br />

Španija, za Hoechst<br />

Marion Roussel<br />

GmbH, Dunaj<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

Avstrija<br />

50 × 250mg A05AA02 PRO.MED.CS., Praga Češka,<br />

Republika<br />

VANCOCIN CP vankomicin 1 steklenička po 1g J01XA01 Lilly Deutchland GmbH, Giessen Nemčija<br />

VANCOCIN CP vankomicin 1 steklenička po 500mg J01XA01 Lilly Deutchland GmbH, Giessen Nemčija<br />

VANCOCIN CP vankomicin 20 × 250mg A07AA09 Eli Lilly and Company Limited,<br />

Basingstoke<br />

VANCOCIN CP vankomicin 20 × 125mg A07AA09 Eli Lilly and Company Limited,<br />

Basingstoke<br />

VANCOLED vankomicin steklenizke 10×500mg J01XA01 Cyanamid International Corporation<br />

Limited,<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

Zurich Švica<br />

VASOFLEX 1 mg prazosin 30 × 1 mg C02CA01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

VASOFLEX 2 mg prazosin 60 × 2 mg C02CA01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

VASOFLEX 5 mg prazosin 60 × 5 mg C02CA01 Alkaloid A.D., Skopje, Republika<br />

Makedonija<br />

VEPESID etopozid 20 × 50 mg L01CB01 Bristol-Myers Squibb Products S.A. Švica<br />

VEPESID etopozid ampule 10×100mg/5ml L01CB01 Bristol-Myers Squibb Products S.A. Švica<br />

VEPESID etopozid 10 × 100 mg L01CB01 Bristol-Myers Squibb Products S.A. Švica<br />

VERAPAMIL verapamil 50 × 80mg C08DA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

VERAPAMIL verapamil ampule 50×5mg/2ml C08DA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

Hrvaška<br />

Hrvaška<br />

1650 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003


Ime zdravila<br />

mednarodno<br />

nelastniško ime<br />

pakiranje ATC Izdelovalec/Proizvajalec<br />

VERAPAMIL verapamil 20 × 120 mg C08DA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

VERAPAMIL verapamil 20 × 80 mg C08DA01 Belupo, zdravila in kozmetika, d.o.o.,<br />

Koprivnica,<br />

VIVALAN viloksazin 100 tablet po 50 mg N06AX09 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

VIVALAN viloksazin 30 tablet po 50 mg N06AX09 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

VODA ZA INJEKCIJE voda za injekcije 50 ampul po 5 ml V07AB LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

VODA ZA INJEKCIJE voda za injekcije 50 ampul po 10 ml V07AB LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

VODA ZA INJEKCIJE voda za injekcije 50 ampul po 2 ml V07AB LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

VODA ZA INJEKCIJE voda za injekcije 50 ampul po 4ml V07AB LEK, tovarna farmacevtskih in<br />

kemičnih izdelkov,<br />

XYLOCAINE mazilo lidokain tuba po 20 g mazila (5%) D04AB01 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

XYLOCAINE 1% lidokain prebodne stekleničke 5×20ml (10mg/ml) N01BB02 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

XYLOCAINE 10% SPRAY lidokain steklenička s pršilom 50ml (100mg/ml) in<br />

nastavkom za odmerjanje<br />

XYLOCAINE 10% SPRAY lidokain steklenička s pršilom 80ml (100mg/ml) in<br />

nastavkom za odmerjanje<br />

N01BB02 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

N01BB02 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

XYLOCAINE 2% lidokain prebodne stekleničke 5×20ml (20mg/ml) N01BB02 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

XYLOCAINE 2% AMPULE lidokain ampule 5×5ml (20mg/ml) N01BB02 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

XYLOCAINE 2% GEL lidokain tuba po 30 g gela (2%) in aplikator N01BB02 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

XYLOCAINE 5% MAZILO lidokain tuba po 35 g mazila (5%) D04AB01 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

XYLOCAINE ADRENALIN lidokain 100 ampul po 1,8 ml raztopine N01BB52 ASTRA, Pharmaceutical production,<br />

Södertälje<br />

ZOLADEX goserelin injekcijska brizga z depo pripravkom<br />

1×3,6mg<br />

L02AE03 Zeneca Limited, Macclesfield,<br />

Cheshire,<br />

Hrvaška<br />

Hrvaška<br />

Velika<br />

Britanija<br />

Velika<br />

Britanija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

d.d., Ljubljana Slovenija<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

Švedska<br />

Velika<br />

Britanija<br />

23.9.2003 EN<br />

<strong>Official</strong> <strong>Journal</strong> of the European Union 1651


EN<br />

1652 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

ANIMAL WELFARE<br />

Appendix B<br />

referred to in Chapter 5, Section B, Subsection I of Annex XIII (*)<br />

List of establishments, including number of non-complying cages<br />

No Name of the establishment County<br />

1 JATA REJA, d.d. Ljubljana, obrat Farma Cerklje<br />

ob Krki<br />

Number of<br />

non-complying cages<br />

Cerklje ob Krki 3 600<br />

2 GRILC ALOJZIJA Senovo 153<br />

3 PETKOVŠEK NIKO Logatec 408<br />

4 KOZJEK TEREZIJA Brezovica 105<br />

5 BOLČINA TEREZIJA Rovte 186<br />

6 BRADEŠKO PAVLE Vrhnika 192<br />

7 PRELOG TOMO Ilirska Bistrica 608<br />

8 LIPOGLAV STOJAN Slovenska Bistrica 672<br />

9 ZˇIGART BUNC DRAGICA Slovenska Bistrica 1 024<br />

10 ZAVRŠNIK ROZALIJA Mozirje 96<br />

11 ZAGOZˇEN STANKO Mozirje 1 152<br />

12 LIPUŠČEK DRAGO Slap ob Idrijci 96<br />

13 FELZER BOGOMIR Podbrdo 196<br />

14 FAN MARIJA Tolmin 280<br />

15 TRINKO EVGEN Tolmin 960<br />

16 BUDIH ANDREJ Miren 2 500<br />

17 GOLOB FLORJAN Idrija 430<br />

18 BAUMAN DRAGICA Lovrenec na Dravskem polju 256<br />

19 KELEMINA MIROSLAVA Ormozˇ 1 728<br />

20 JANEZˇIČ MIRKO Škocjan 66<br />

21 ŠVALJ JOZˇE Šentjernej 576<br />

22 KAFOL IVAN Mirna 370<br />

23 AHAČIČ PETER Krizˇe 100<br />

24 MALI FRANC Naklo 120<br />

25 ROZMAN HELENA Duplje 192<br />

26 KOLEZˇNIK ANTON Kranj 120<br />

27 GOLIČIČ JOZˇE Škofja Loka 333<br />

28 FRELIH MARJAN Bled 360<br />

(*) For the text of Annex XIII see OJ L 236, 23.9.2003, p. 906.


EN<br />

23.9.2003 <strong>Official</strong> <strong>Journal</strong> of the European Union 1653<br />

No Name of the establishment County<br />

Number of<br />

non-complying cages<br />

29 GLOBOČNIK ALEŠ Šenčur 720<br />

30 VOK BRANIMIR Stranice 192<br />

31 SALOBIR JANKO Šentrupert pri Laškem 768<br />

32 GOTAR ZDENKA Laško 720<br />

33 ŠAJTEGL ANTON Slovenske Konjice 140<br />

34 MAVC PAVLA Vitanje 140<br />

35 KOBALE MARJAN Loče 72<br />

36 GOSAK BOJAN Loče 270<br />

37 JAKOP VILI Vitanje 216


EN<br />

1654 <strong>Official</strong> <strong>Journal</strong> of the European Union 23.9.2003<br />

Appendix<br />

referred to in Chapter 5, Section B to Annex XIV (*)<br />

List of establishments, including shortcomings and deadlines for the correction of these shortcomings<br />

No Vet. No Name of the establishment Shortcomings<br />

1 GA 6-2 Sered'sky´ MP a.s.,<br />

Bratislavská 385,<br />

Sered'<br />

2 PB 5-6-1 Slovryb a.s.,<br />

Príbovce Hospodárske<br />

stredisko Povazˇská<br />

Bystrica-Rybníky,<br />

Zˇilinská 776/3, 017 01<br />

(*) For the text of Annex XIV see OJ L 236, 23.9.2003, p. 915.<br />

Council Directive 64/433/EEC:<br />

Annex I, Chapter I, point 1(a), (b) and (g)<br />

Annex I, Chapter I, point 11<br />

Annex I, Chapter II, point 14(a)<br />

Council Directive 77/99/EEC:<br />

Annex A, Chapter I, point 2(a), (b) and (c)<br />

Annex A, Chapter I, point 11<br />

Council Directive 91/493/EEC<br />

Annex, Chapter III.I point 1<br />

Annex, Chapter III.I point 2(a), (b), (c), (d), (e) and (g)<br />

Annex, Chapter III.I point 9<br />

Date of full<br />

compliance<br />

31.12.2006<br />

30.11.2006

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