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Lupocet 500 mg tablets tablets Lupocet BABY 120 mg suppositories suppositories Lupocet flu effervescent tablets Lupocet JUNIOR syrup syrup Lupocet TEEN 300 mg capsules Luveris 75 IU capsules powder and diluent for preparation of solution for injection (for subcutaneous use) Luxeta tablets 100 mg film tablets Luxeta tablets 50 mg film tablets Lyrica 100 mg capsules capsules, hard Lyrica 150 mg capsules capsules, hard Lyrica 200 mg capsules capsules, hard Lyrica 25 mg capsules capsules, hard Lyrica 300 mg capsules capsules, hard Lyrica 50 mg capsules capsules, hard Lyrica 75 mg capsules capsules, hard Belupo, lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Republic of Croatia Belupo, lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Republic of Croatia Belupo, lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Republic of Croatia Belupo, lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Republic of Croatia Belupo, lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Republic of Croatia Industria Farmaceutica Serono S.p.A., Bari, Italy Pliva Croatia Ltd., Ulica grada Vukovara 49, Zagreb, Republic of Croatia Pliva Croatia Ltd., Ulica grada Vukovara 49, Zagreb, Republic of Croatia Pfizer GmbH Arzneimittelwerk Gödecke, Mooswaldallee 1, Freiburg, Germany Pfizer GmbH Arzneimittelwerk Gödecke, Mooswaldallee 1, Freiburg, Germany Pfizer GmbH Arzneimittelwerk Gödecke, Mooswaldallee 1, Freiburg, Germany Pfizer GmbH Arzneimittelwerk Gödecke, Mooswaldallee 1, Freiburg, Germany Pfizer GmbH Arzneimittelwerk Gödecke, Mooswaldallee 1, Freiburg, Germany Pfizer GmbH Arzneimittelwerk Gödecke, Mooswaldallee 1, Freiburg, Germany Pfizer GmbH Arzneimittelwerk Gödecke, Mooswaldallee 1, Freiburg, Germany 10 (1x10) tablets in a PVC/Al blister, supplied in a box 10 (2x5) suppositories in a PE/Al strip, supplied in a box 10 effervescent tablets in a plastic tube, supplied in a box 100 mL of syrup in an amber glass bottle, supplied in a box 20 (2x10) capsules in a (PVC/Al) blister, supplied in a box Vial with powder and vial with diluent, in a protective container, supplied in a box 28 tablets in a blister, supplied in a box 28 tablets in a blister, supplied in a box 84 (4x21) capsules in a blister (PVC/Al), supplied in a box 56 (4x14) capsules in a blister (PVC/Al), supplied in a box 84 (4x21) capsules in a blister (PVC/Al), supplied in a box 56 (4x14) capsules in a blister (PVC/Al), supplied in a box 56 (4x14) capsules in a blister (PVC/Al), supplied in a box 56 (4x14) capsules in a blister (PVC/Al), supplied in a box 56 (4x14) capsules in a blister (PVC/Al), supplied in a box YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES 14509/11 WS/jj 320 ANNEX II DGF 2A / DG K 2 EN
LYSOBACT oriblets MabCampath 30 mg/mL concentrate for infusion solution MabThera 100 mg solution concentrate for infusion MabThera 500 mg concentrate of solution for infusion tablets for oral cavity oral (orbilettes) concentrate for infusion solution solution concentrate for infusion concentrate of solution for infusion Macugen 0.3 mg solution for injection Madopar 125 tablets tablets Madopar HBS 125 capsules Madopar LIQ 125 tablets for oral suspension Magnevist solution for injection Magnevist solution for injection capsules tablets for oral suspension solution for injection solution for injection Makcin 500 mg tablets film coated tablets MANIT 10% solution for infusion MANIT 20% solution for infusion Marivarin 3 mg tablets tablets Materna with selenium film coated tablets MAXALT RPD 10 mg oral lyophilisates oral lyophilisate Bosnalijek d.d., Jukićeva 53, Sarajevo, Bosnia and Herzegovina Schering AG, Muellerstrasse 170- 178, Berlin, Germany F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, Basel, Switzerland F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, Basel, Switzerland Pfizer Health AB, Stockholm, Sweden F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, Basel, Switzerland F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, Basel, Switzerland F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, Basel, Switzerland Schering AG, Muellerstrasse 170- 178, Berlin, Germany Schering AG, Muellerstrasse 170- 178, Berlin, Germany Belupo, lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Republic of Croatia Pliva Croatia Ltd., Ulica grada Vukovara 49, Zagreb, Republic of Croatia Pliva Croatia Ltd., Ulica grada Vukovara 49, Zagreb, Republic of Croatia Krka d.d., Novo mesto, Republic of Slovenia in cooperation with Orion Corporation, Espoo, Finland Wyeth Lederle S.p.A., Catania, Italy Merck Sharp & Dohme B.V., Waarderweg 39, Postbus 581, Haarlem, The Nederlands 30 (3x10) tablets in a blister, supplied in a box 3x1 glass bottles with 1 mL of concentrate for solution for infusion, supplied in a box 10 mL of infusion solution concentrate in a glass bottle, 2 bottles in a box 50 mL of solution for infusion concentrate in a glass bottle, supplied in a box One glass pre-filled syringe with needle, in a protective bag, supplied in a box 100 tablets in an amber glass bottle (with desiccant), supplied in a box 30 capsules in an amber glass bottle (with a desiccant), supplied in a box 100 tablets in an amber glass bottle (with dessicant), supplied in a box 20 mL of solution in a glass bottle with rubber stopper, supplied in a box 10 mL of solution in a glass bottle with rubber stopper, supplied in a box 14 (1x14) tablets in a blister, supplied in a box 500 mL of solution in a glass infusion bottle with a rubber stopper and a protective cap, 10 bottles in a box 250-mL of solution in a glass bottle for infusion with rubber stopper and protective cap, 10 bottles in a box 50 tablets in an amber glass bottle with an aluminium stopper 30 tablets in a HDPE bottle, supplied in a box 2 (2x1) oral lyophilisate in a blister (PVC/PVDC//Al) and protective bag (paper/PE/Al), in a plastic box, supplied in a carton box YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES 14509/11 WS/jj 321 ANNEX II DGF 2A / DG K 2 EN
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Conseil UE COUNCIL OF THE EUROPEAN
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TABLE OF CONTENTS A. Treaty between
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Annex IV: List referred to in Artic
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FINAL ACT I. Text of the Final Act.
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HER MAJESTY THE QUEEN OF DENMARK, T
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HAVE AGREED on the conditions of ad
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HIS ROYAL HIGHNESS THE GRAND DUKE O
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ARTICLE 1 1. The Republic of Croati
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ARTICLE 4 This Treaty, drawn up in
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SOM BEKRÄFTELSE PÅ DETTA har unde
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Per il Presidente della Repubblica
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ACT concerning the conditions of ac
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3. Croatia is in the same situation
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ARTICLE 5 Croatia shall participate
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Should the amendments to the bilate
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ARTICLE 7 1. The provisions of this
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ARTICLE 10 The Protocol on the Stat
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TITLE II OTHER ADJUSTMENTS ARTICLE
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PART THREE PERMANENT PROVISIONS ART
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2. By way of derogation from Articl
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Acts shall be adopted if there are
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Belgium 12 Bulgaria 12 Czech Republ
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Belgium 12 Bulgaria 12 Czech Republ
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TITLE III FINANCIAL PROVISIONS ARTI
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ARTICLE 29 1. Procurement, grant aw
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5. Assistance under the Transition
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3. For the period covered by the ne
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TITLE IV OTHER PROVISIONS ARTICLE 3
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3. The measures authorised under th
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ARTICLE 41 If transitional measures
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PART FIVE PROVISIONS RELATING TO TH
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ARTICLE 50 Where acts of the instit
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ANNEX I List of conventions and pro
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ANNEX II List of provisions of the
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- the Agreement between the Europea
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SCH/Com-ex (98) 1 rev 2 Decision of
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Council Decision 1999/435/EC of 20
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Council Directive 2003/110/EC of 25
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Council Decision 2007/801/EC of 6 D
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ANNEX III List referred to in Artic
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II. SUPPLEMENTARY PROTECTION CERTIF
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4. AGRICULTURE 1. 31991 R 1601: Cou
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Member States or regions 'ANNEX VI
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(i) In paragraph 2 of the Appendix
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(b) In Article 6(2), the first subp
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(l) In Article 57(3), the following
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9. By 15 July 2013, Croatia shall n
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(t) Article 121 is replaced by the
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(w) In Annex VIII, the following ta
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12. COASTAL WATERS OF SLOVENIA* Geo
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(e) In Annex II, point (a), the tab
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Article 46(3) is replaced by the fo
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(b) 4,98 % (i.e. a total of EUR 12
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8. Article 28 is amended as follows
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16. In Article 56(3), the following
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20. In Article 75, the following pa
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27. The following Article is insert
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4. For the operations approved unde
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30. Annex III is replaced by the fo
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The following Article is inserted:
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(b) In Annex IIa, the following is
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2. COMPETITION POLICY Treaty on the
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3. AGRICULTURE (a) Treaty on the Fu
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Croatia shall, where necessary, ame
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(b) any of the means of proof of Un
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5. Croatia is authorised to retain
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(b) the proof of origin is submitte
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14. The procedures governing custom
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OTHER PROVISIONS 18. Authorisations
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ANNEX V List referred to in Article
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Croatian nationals legally working
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A Member State referred to in the f
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The list of service sectors which m
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3. FREE MOVEMENT OF CAPITAL Treaty
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3. 32007 R 1234: Council Regulation
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II. TRANSITIONAL TARIFF QUOTA FOR R
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Eggs from those un-enriched cages s
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e) Croatia shall continuously monit
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(a) Croatia must have in place on o
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7. TRANSPORT POLICY 1. 31992 R 3577
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Member States that apply the transi
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(b) the international transport of
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(ii) By way of derogation from Arti
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(xiv) By way of derogation from poi
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Croatia shall ensure a gradual redu
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2. 31998 L 0083: Council Directive
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(ii) As from 1 January 2015: 1. HEM
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27. OBRT ZA PRANJE I ČIŠĆENJE TE
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(a) As from 1 January 2014: 1. NAŠ
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(d) As from 1 January 2016: 1. FERR
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20. PURIS, poljoprivredna, prehramb
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10. DIOKI Organska petrokemija dion
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Appendix to Annex V List(*) as prov
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C. Leader In the rural development
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G. Modernisation of agricultural ho
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ANNEX VIII Commitments undertaken b
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Any subsequent change to these plan
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− the overall production limitati
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PROTOCOL on certain arrangements co
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The AAUs to be transferred shall be
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1. The Plenipotentiaries of: I. TEX
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Assembled at [city to be inserted]
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Annex IX: Commitments undertaken by
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5. The Plenipotentiaries have taken
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Per il Presidente della Repubblica
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II. DECLARATIONS [A.] JOINT DECLARA
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[C.] JOINT DECLARATION BY THE PRESE
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III. EXCHANGE OF LETTERS between th
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ANNEX Information and consultation
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13. Certain non-preferential agreem
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NAME OF THE MEDICINAL PRODUCT 1M po
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Agrippal vaccine against influenza
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Alomax 5% dermal solution Alomide 1
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AmLodipin Cipla 10 mg tablets AmLod
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Angal lozenges lozenges Angal S ora
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Aranesp 40 micrograms of solution f
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Asentra 50 mg film coated tablets A
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Atropini sulfas 1 mg/mL injection A
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Balance 1.5% glucose, 1.75 mmol/l c
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Belosalic lotion lotion Belosalic o
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Bilobil forte capsules 80 mg capsul
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Brinerdin coated tablets coated tab
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Canesten 3 vaginal tablets 0.2 g Ca
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CAPD/DPCA 2 sleep safe CAPD/DPCA 2
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CARVETREND tablets 25 mg CARVETREND
Page 251 and 252:
Certican 0.25 mg tablets for oral s
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Ciprinol film coated tablets 500 mg
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Live, lyophilized morbilli and rube
Page 257 and 258:
Claccium Folinat Ebewe 50 mg/5 mL s
Page 259 and 260:
CO-Diovan film-tablets 160/12.5 mg
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CORTEF tablets 10 mg tablets Coryol
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DALERON C JUNIOR granules for oral
Page 265 and 266:
Deprozel tablets 30 mg film coated
Page 267 and 268:
Diazepam Desitin 5 mg rectal soluti
Page 269 and 270: Diprosalic ointment ointment Disopr
Page 271 and 272: Duphaston film coated tablets Dupha
Page 273 and 274: Efectin ER capsules 37.5 mg Efectin
Page 275 and 276: Eminens 2 mg tablets film coated ta
Page 277 and 278: Epirubicin Ebewe 100 mg/50 mL Epiru
Page 279 and 280: Estraderm TTS 100 transdermal patch
Page 281 and 282: Fabrazyme 35 mg Fabrazyme 5 mg powd
Page 283 and 284: FERVEX granules for oral solution F
Page 285 and 286: FLUIMUN, vaccine against influenza
Page 287 and 288: Fursemid 40 mg tablets tablets Furs
Page 289 and 290: Gentamicin injection 80 mg Gentamic
Page 291 and 292: Glukosalina I solution for intraven
Page 293 and 294: GONAL-f 450 IU/0.75 mL GONAL-f 450
Page 295 and 296: Hemofil M 500 IU human coagulation
Page 297 and 298: HUMAN ALBUMIN 20% OCTAPHARMA 50 mL
Page 299 and 300: Imigran nasal spray of 20 mg nasal
Page 301 and 302: INFANRIX-IPV+Hib, Combined Diphther
Page 303 and 304: Iopamiro 300 solution for injection
Page 305 and 306: Sodium chloride isotinic solution 0
Page 307 and 308: Keppra 500 mg film coated tablets K
Page 309 and 310: Klimicin V 2% vaginal cream vaginal
Page 311 and 312: Laaven HD tablets tablets Laaven HD
Page 313 and 314: Lamisil once 1% dermal solution Lan
Page 315 and 316: Lercanil film coated tablets Lescol
Page 317 and 318: LIPIDIL 200 M capsules, hard Lipofu
Page 319: Losartic tablets 25 mg film coated
Page 323 and 324: Meglimid 1 mg tablets tablets Megli
Page 325 and 326: Minirin 0.2 mg tablets tablets Mira
Page 327 and 328: Mostrafin tablets film coated table
Page 329 and 330: Naklofen gastric-resistant tablets
Page 331 and 332: Sodium chloride 10% electrolytes co
Page 333 and 334: Nephrotect solution for infusion Ne
Page 335 and 336: Nolpaza 20 mg Nolpaza 40 mg gastric
Page 337 and 338: NovoRapid Penfill solution for inje
Page 339 and 340: NUROFEN oral suspension for childre
Page 341 and 342: OliClinomel N7 - 1000 E emulsion fo
Page 343 and 344: Operil 0.05% nasal spray nasal spra
Page 345 and 346: OxyContin 80 mg prolonged-release t
Page 347 and 348: Pantexol cream cream Pantexol ointm
Page 349 and 350: Pentasa 1 g suppositories supposito
Page 351 and 352: Plavix film coated tablets PLICET E
Page 353 and 354: Portal 20 mg capsules capsules Port
Page 355 and 356: Procoralan 7.5 mg film coated table
Page 357 and 358: Protecta 20 mg tablets film coated
Page 359 and 360: Ranix 150 film tablets Ranix 300 fi
Page 361 and 362: Requip 5 mg tablets film coated tab
Page 363 and 364: Risset tablets 3 mg film coated tab
Page 365 and 366: Salofalk suspension for rectal admi
Page 367 and 368: Serdolect 4 mg film coated tablets
Page 369 and 370: Simcard 10 film coated tablets Simc
Page 371 and 372:
Skopryl 20 mg tablets Compound sodi
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SOMAVERT injection 20 mg SOMAVERT i
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Stocrin 200 mg capsules capsules ST
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Stugeron forte tablets tablets Subu
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Symbicort Turbuhaler 320/9 µg Symb
Page 381 and 382:
Tantum Verde gargling solution Tant
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Temodal capsules 100 mg capsules, h
Page 385 and 386:
TINIDIL sublingual tablets TIRAMAT
Page 387 and 388:
TRALIN tablets 100 mg film coated t
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Tritace 1.25 tablets Tritace 2.5 ta
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Ultravist 370 solution for injectio
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VAXIGRIP Pediatric use - inactivate
Page 395 and 396:
Vincristine injection 1 mg VIRACEPT
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Water for Injections Viaflo diluent
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Yasmin film tablets film coated tab
Page 401 and 402:
Zipantola 40 mg tablets gastric-res
Page 403:
_____________________ 14509/11 WS/j
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