450 Iris Oifigiúil an Aontais Eorpaigh 23.9.2003 - EUR-Lex
450 Iris Oifigiúil an Aontais Eorpaigh 23.9.2003 - EUR-Lex
450 Iris Oifigiúil an Aontais Eorpaigh 23.9.2003 - EUR-Lex
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GA<br />
<strong>450</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><br />
Foscríbhinn A<br />
dá dtagraítear i gCaibidil 1, pointe 2, d'Iarscríbhinn XI (*)<br />
Liosta de tháirgí cógaisíochta arna sholáthar ag Málta i dte<strong>an</strong>ga amháin a bhf<strong>an</strong>faidh údarú margaíochta arna eisiúint ina<br />
leith faoi dhlí Mhálta roimh dháta <strong>an</strong> aontachais bailí go dtí go ndé<strong>an</strong>far é a athnuach<strong>an</strong> i gcomhlíonadh <strong>an</strong> acquis, nó<br />
go dtí <strong>an</strong> 31 Nollaig 2006, cibé acu is túisce.<br />
Má luaitear táirge cógaisíochtasa liosta seo, ní dhé<strong>an</strong><strong>an</strong>n sin réamhbhreith cé acu <strong>an</strong> bhfuil nó nach bhfuil údarú<br />
margaíochta i gcomhlíonadh <strong>an</strong> acquis ag <strong>an</strong> táirge cógaisíochta i dtrácht.<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 />
N/A BAXTER HEALTHCARE<br />
LIMITED<br />
(*) Don téacs den Iarscríbhinn XI féach IO L 236 (Eagrán Speisialta), <strong>23.9.2003</strong>, lch. 859.<br />
GERMANY<br />
UNITED KINGDOM
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
452 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
454 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 PAST<strong>EUR</strong> 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>EUR</strong>OPE R&D<br />
CENTRE LIMITED<br />
ACTOS TABLETS 30MG TAKEDA <strong>EUR</strong>OPE 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
GA<br />
456 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 PAST<strong>EUR</strong> 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
458 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 />
<strong>EUR</strong>OPEAN 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
GA<br />
460 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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-COUVR<strong>EUR</strong><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
GA<br />
462 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
464 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
466 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 <strong>EUR</strong>OPE<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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
468 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
470 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
472 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
474 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
476 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
478 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 PAST<strong>EUR</strong> MERIEUX FRANCE<br />
AVELOX FILM-COATED TABLET 400MG BAYER VITAL GMBH &<br />
CO. KG<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN 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. <strong>EUR</strong>OPEAN 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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
ITALY
GA<br />
480 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
482 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
484 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
486 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
IRELAND<br />
TABLET 8MG GENERICS (UK) LIMITED UNITED KINGDOM<br />
1G MUSTAFA NEVZAT ILAC<br />
SANAYII A.S.<br />
TURKEY
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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-COUVR<strong>EUR</strong><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
GA<br />
488 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
490 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
492 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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-COUVR<strong>EUR</strong><br />
N.V.<br />
NO ACTIVE ING. ALCON LABORATORIES<br />
INC.<br />
BELGIUM<br />
UNITED STATES OF<br />
AMERICA
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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-COUVR<strong>EUR</strong><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
GA<br />
494 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
496 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
498 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 />
<strong>450</strong>MG/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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
UNITED KINGDOM<br />
<strong>EUR</strong>OPEAN COMMUNITY
GA<br />
500 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
502 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
504 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>EUR</strong>OPE<br />
LIMITED<br />
0.25MG/VIAL SERONO <strong>EUR</strong>OPE<br />
LIMITED<br />
0.25MG/VIAL SERONO <strong>EUR</strong>OPE<br />
LIMITED<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY
GA<br />
506 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
508 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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-COUVR<strong>EUR</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
510 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
512 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN 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
GA<br />
514 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>EUR</strong>OPHARM<br />
LIMITED<br />
COMTAN FILM-COATED TABLETS 200MG NOVARTIS <strong>EUR</strong>OPHARM<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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
UNITED KINGDOM<br />
UNITED KINGDOM
GA<br />
516 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
518 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
520 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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-COUVR<strong>EUR</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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) PAST<strong>EUR</strong> MERIEUX FRANCE<br />
D.T. POLIO VACCINE VACCINE N/A PAST<strong>EUR</strong> MERIEUX FRANCE<br />
D.T. VAX INJECTABLE<br />
PREPARATION<br />
INDIA<br />
N/A PAST<strong>EUR</strong> 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
GA<br />
522 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
524 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
526 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
528 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
530 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
532 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
534 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
536 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
538 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
540 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
542 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>EUR</strong>OPE<br />
EEIG<br />
40MG PHARMACIA <strong>EUR</strong>OPE<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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN 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
GA<br />
544 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
546 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>EUR</strong>OPA 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
GA<br />
548 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
550 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
552 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 />
<strong>EUR</strong>AX CREAM 100MG/G NOVARTIS CONSUMER<br />
HEALTH SA<br />
<strong>EUR</strong>AX LOTION 100MG/G NOVARTIS CONSUMER<br />
HEALTH SA<br />
<strong>EUR</strong>OCEFIX CAPSULES 500MG FARMA UNO SRL ITALY<br />
<strong>EUR</strong>OCEFIX 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 />
<strong>EUR</strong>OPHARMA LIMITED<br />
EXELON HARD GELATIN CAPSULE NA NOVARTIS PHARMA<br />
SCHWIEZ AG<br />
EXELON HARD CAPSULES 1.5MG NOVARTIS <strong>EUR</strong>OPHARM<br />
LIMITED<br />
EXELON HARD CAPSULES 3MG NOVARTIS <strong>EUR</strong>OPHARM<br />
LIMITED<br />
EXELON HARD CAPSULES 4.5MG NOVARTIS <strong>EUR</strong>OPHARM<br />
LIMITED<br />
SWITZERLAND<br />
UNITED KINGDOM<br />
SWITZERLAND<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY
GA<br />
554 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><br />
Trade Name Dosage Form Dose MA Holder Country<br />
EXELON HARD CAPSULES 6MG NOVARTIS <strong>EUR</strong>OPHARM<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 />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
556 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>450</strong>MG NORTON HEALTHCARE<br />
LIMITED<br />
FENBUFEN <strong>450</strong>MG TABLETS COATED TABLET <strong>450</strong>MG 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
GA<br />
558 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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-COUVR<strong>EUR</strong><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
GA<br />
560 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
562 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
564 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
566 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
568 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
570 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
572 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
574 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>EUR</strong>OPHARM<br />
LIMITED<br />
GLIVEC HARD CAPSULES 100MG NOVARTIS <strong>EUR</strong>OPHARM<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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY
GA<br />
576 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>EUR</strong>OPE<br />
LIMITED<br />
150 IU SERONO <strong>EUR</strong>OPE<br />
LIMITED<br />
150 IU SERONO <strong>EUR</strong>OPE<br />
LIMITED<br />
150 IU SERONO <strong>EUR</strong>OPE<br />
LIMITED<br />
GONAL-F 75 POWDER FOR INJECTION 75 IU/3ML ARES SERONO (<strong>EUR</strong>OPE)<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
GA<br />
578 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
580 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
582 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
584 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
586 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
588 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
590 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 PAST<strong>EUR</strong> MERIEX<br />
SERUMS ET VACCINS<br />
IMOVAX POLIO INJECTABLE SOLUTION N/A PAST<strong>EUR</strong> 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
592 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN 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 />
<strong>450</strong>0IU/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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
594 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 <strong>EUR</strong>OPE IRELAND<br />
25 MILLION IU SP <strong>EUR</strong>OPE 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 />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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-COUVR<strong>EUR</strong><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
GA<br />
596 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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-COUVR<strong>EUR</strong><br />
N.V.<br />
ISOPTO CARPINE 2% OPHTHALMIC SOLUTION 2% W/V S.A. ALCON-COUVR<strong>EUR</strong><br />
N.V.<br />
ISOPTO CARPINE 4% OPHTHALMIC SOLUTION 4% W/V S.A. ALCON-COUVR<strong>EUR</strong><br />
N.V.<br />
ISOPTO FENICOL 0.5% OPHTHALMIC SOLUTION 5MG/ML S.A. ALCON-COUVR<strong>EUR</strong><br />
N.V.<br />
ISOPTO FENICOL<br />
0.5%/CHLORAMPHENICOL 0.5%<br />
OPHTHALMIC SOLUTION 0.5% W/V S.A. ALCON-COUVR<strong>EUR</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>EUR</strong>OPE R&D<br />
CENTRE LIMITED<br />
IXENSE SUBLINGUAL TABLETS 3MG TAKEDA <strong>EUR</strong>OPE 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
GA<br />
598 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
600 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
602 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 DOCT<strong>EUR</strong><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 DOCT<strong>EUR</strong><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
GA<br />
604 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
606 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
608 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
610 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
612 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
614 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
616 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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-<strong>450</strong> CAPSULES <strong>450</strong>MG MACLEODS<br />
PHARMACEUTICALS LTD<br />
INDIA<br />
INDIA<br />
INDIA<br />
INDIA<br />
INDIA
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
618 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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-COUVR<strong>EUR</strong><br />
N.V.<br />
MAXIDEX OPHTHALMIC OINTMENT 1MG/G S.A. ALCON-COUVR<strong>EUR</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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-COUVR<strong>EUR</strong><br />
N.V.<br />
MAXITROL OPHTHALMIC OINTMENT N/A S.A. ALCON-COUVR<strong>EUR</strong><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
GA<br />
620 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
622 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 PAST<strong>EUR</strong>, INC. UNITED STATES OF<br />
AMERICA<br />
MENOMUNE-A/C/Y/W-135 COMBINED VACCINE N/A AVENTIS PAST<strong>EUR</strong> 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
624 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
626 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>EUR</strong>OPEAN 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
GA<br />
628 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
630 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 COUVR<strong>EUR</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
632 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
634 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
636 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
638 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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-COUVR<strong>EUR</strong><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
GA<br />
640 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
642 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 <strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 />
N<strong>EUR</strong>OBAT SUGAR COATED TABLET N/A PT INTERBAT INDONESIA<br />
N<strong>EUR</strong>OLITE DRY SUBSTANCE AND<br />
SOLVENT<br />
N/A DUPONT PHARMA GMBH GERMANY<br />
N<strong>EUR</strong>OMULTIVIT FILM COATED TABLETS N/A LANNACHER HEILMITTEL<br />
GES.M.B.H.<br />
AUSTRIA<br />
N<strong>EUR</strong>ONTIN 100MG CAPSULE 100MG PARKE-DAVIS GMBH GERMANY<br />
N<strong>EUR</strong>ONTIN 300MG CAPSULE 300MG PARKE-DAVIS GMBH GERMANY<br />
N<strong>EUR</strong>ONTIN 400MG CAPSULE 400MG PARKE-DAVIS GMBH GERMANY<br />
N<strong>EUR</strong>ONTIN CAPSULES 100MG CAPSULE 100MG WARNER LAMBERT (UK)<br />
LIMITED T/A PARKE<br />
DAVIS<br />
N<strong>EUR</strong>ONTIN CAPSULES 100MG CAPSULE 100MG WARNER LAMBERT (UK)<br />
LTD. T/A PARKE DAVIS<br />
N<strong>EUR</strong>ONTIN CAPSULES 300MG CAPSULE 300MG WARNER LAMBERT (UK)<br />
LTD. T/A PARKE DAVIS<br />
N<strong>EUR</strong>ONTIN TABLETS 600MG FILM COATED TABLET 600MG WARNER LAMBERT (UK)<br />
LTD. T/A PARKE DAVIS<br />
N<strong>EUR</strong>ONTIN TABLETS 800MG FILM COATED TABLET 800MG WARNER LAMBERT (UK)<br />
LTD. T/A PARKE DAVIS<br />
N<strong>EUR</strong>O-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 />
N<strong>EUR</strong>ORUBIN LACTABS N/A MEPHA PHARMA AG SWITZERLAND<br />
N<strong>EUR</strong>ORUBINE SOLUTION FOR<br />
INJECTION<br />
N/A MEPHA PHARMA AG SWITZERLAND<br />
N<strong>EUR</strong>ORUBINE 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
GA<br />
644 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
646 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
648 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
650 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
652 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 <strong>EUR</strong>OPEAN COMMUNITY<br />
100U/ML NOVO NORDISK A/S <strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
654 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
656 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
658 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
660 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 PAST<strong>EUR</strong> 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
662 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
664 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
666 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>450</strong>MG/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 <strong>450</strong>MG 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
GA<br />
668 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
SEE REMARKS SP <strong>EUR</strong>OPE <strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 PAST<strong>EUR</strong> 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
GA<br />
670 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
672 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
674 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 PAST<strong>EUR</strong> 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 PAST<strong>EUR</strong> MERIEUX FRANCE<br />
POLYSILANE DELALANDE CHEWABLE TABLET N/A LABORATOIRES<br />
SYNTHELABO<br />
FRANCE
GA<br />
676 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
678 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 />
VASOCONSTRICT<strong>EUR</strong> 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 />
<strong>EUR</strong>OPEAN 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
GA<br />
680 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
682 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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-COUVR<strong>EUR</strong><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
GA<br />
684 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
686 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>EUR</strong>OPA 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 <strong>EUR</strong>OPE 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 (<strong>EUR</strong>OPE)<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
GA<br />
688 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPE B.V.<br />
500IU GENETICS INSTITUTE OF<br />
<strong>EUR</strong>OPE B.V.<br />
1000IU GENETICS INSTITUTE OF<br />
<strong>EUR</strong>OPE B.V.<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
690 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
692 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
694 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 PAST<strong>EUR</strong> 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 PAST<strong>EUR</strong> 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
GA<br />
696 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
698 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
700 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
702 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
704 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 <strong>EUR</strong>OPHARM<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 />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
706 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
708 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 — SECT<strong>EUR</strong><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 <strong>EUR</strong>OPA LTD. UNITED KINGDOM<br />
SONATA HARD CAPSULE 10MG WYETH <strong>EUR</strong>OPA 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
GA<br />
710 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 PAST<strong>EUR</strong> 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 <strong>EUR</strong>OPHARM<br />
LIMITED<br />
STARLIX FILM-COATED TABLETS 120MG NOVARTIS <strong>EUR</strong>OPHARM<br />
LIMITED<br />
STARLIX FILM COATED TABLETS 180MG NOVARTIS <strong>EUR</strong>OPHARM<br />
LIMITED<br />
STARLIX FILM COATED TABLETS 60MG NOVARTIS <strong>EUR</strong>OPHARM<br />
LIMITED<br />
STARLIX FILM COATED TABLETS 120MG NOVARTIS <strong>EUR</strong>OPHARM<br />
LIMITED<br />
STARLIX FILM COATED TABLETS 180MG NOVARTIS <strong>EUR</strong>OPHARM<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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN 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
GA<br />
712 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
714 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
716 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
718 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
720 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
<strong>EUR</strong>OPEAN 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
GA<br />
722 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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-COUVR<strong>EUR</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
724 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 PAST<strong>EUR</strong> S.A FRANCE<br />
TETAVAX SUSP F INJ IN VIAL 40IU/0.5ML AVENTIS PAST<strong>EUR</strong> S.A FRANCE<br />
TETAVAX ADSORBED<br />
ANTI-TETANUS VACCINE<br />
INJECTABLE SUSPENSION 40IU/VACCINE PAST<strong>EUR</strong> MERIEUX FRANCE<br />
TETMOSOL SOAP 5% W/W ZENECA LIMITED UNITED KINGDOM<br />
TETRACOQ INJECTABLE SUSPENSION N/A PAST<strong>EUR</strong> MERIEUX FRANCE<br />
TETRACT HIB SUSPENSION FOR<br />
INJECTION<br />
N/A PAST<strong>EUR</strong> 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
726 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
728 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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-COUVR<strong>EUR</strong><br />
N.V<br />
TOBRADEX OPHTHALMIC OINTMENT N/A S.A ALCON-COUVR<strong>EUR</strong><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-COUVR<strong>EUR</strong><br />
N.V.<br />
TOBREX OPHTHALMIC OINTMENT 3MG/G S.A. ALCON-COUVR<strong>EUR</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
730 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 />
<strong>EUR</strong>OPEAN 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
GA<br />
732 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN COMMUNITY<br />
FRANCE<br />
N/A EVANS MEDICAL LIMITED UNITED KINGDOM<br />
TRIVEDON-20 TABLET 20MG CIPLA LIMITED INDIA
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 PAST<strong>EUR</strong><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
GA<br />
734 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN 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 PAST<strong>EUR</strong> 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
736 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 PAST<strong>EUR</strong> MERIEUX FRANCE<br />
VACCIN POLIOMYELITIQUE ORAL ORAL SOLUTION N/A LABORATORIES<br />
PAST<strong>EUR</strong> 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
GA<br />
738 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 PAST<strong>EUR</strong> S.A. FRANCE<br />
NA AVENTIS PAST<strong>EUR</strong> 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 <strong>450</strong>MG 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
GA<br />
740 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 PAST<strong>EUR</strong> 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 COUVR<strong>EUR</strong><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
GA<br />
742 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
744 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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-COUVR<strong>EUR</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
746 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
748 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
750 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
752 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
754 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
756 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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 <strong>EUR</strong>OPHARM<br />
LIMITED<br />
SWITZERLAND<br />
<strong>EUR</strong>OPEAN 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
GA<br />
758 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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 />
<strong>EUR</strong>OPEAN 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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
GA<br />
760 <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> <strong>23.9.2003</strong><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
GA<br />
<strong>23.9.2003</strong> <strong>Iris</strong> <strong>Oifigiúil</strong> <strong>an</strong> <strong>Aontais</strong> <strong>Eorpaigh</strong> 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
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