PUBLIC - Croatia, the War, and the Future

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Octaplas SD blood type B solution for infusion Octenisept solution Oikamid capsules Oikamid injection solution for injection Oikamid injection solution for injection Oikamid capsules capsules Oksazepam 10 mg tablets tablets Oksazepam 30 mg tablets tablets Olanzapin CIPLA 10 mg film coated tablets Olanzapin CIPLA 2.5 mg film coated tablets Olanzapin CIPLA 5 mg film coated tablets Olicard 40 mg retard Olicard 60 mg retard prolonged release capsules prolonged release capsules OliClinomel N4 - 550E emulsion for infusion OliClinomel N4 - 550E emulsion for infusion OliClinomel N6 - 900 E emulsion for infusion Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria Schulke & Mayr GmbH, Norderstedt, Germany Pliva Croatia Ltd., Ulica grada Vukovara 49, Zagreb, 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 Pliva Croatia Ltd., Ulica grada Vukovara 49, Zagreb, 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 Cipla Ltd., Kurkumbh Industrial Area, Maharashtra State, India Cipla Ltd., Kurkumbh Industrial Area, Maharashtra State, India Cipla Ltd., Kurkumbh Industrial Area, Maharashtra State, India 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 Clintec Parenteral S.A., France; Baxter S.A., Lessines, Belgium Clintec Parenteral S.A., France; Baxter S.A., Lessines, Belgium Clintec Parenteral S.A., France; Baxter S.A., Lessines, Belgium 200 mL of solution in sterile PVC transfusion bags coated with polyamide/polyethylene film 50 mL of solution in a plastic bottle with a spray pump Box with 60 capsules in a blister (5x12) 10 ampoules each containing 5 mL of solution, supplied in a box 10 ampoules each containing 5 mL of solution, supplied in a box Box with 60 capsules in a blister (5x12) 30 (3X10) tablets in a PVC/Al foil blister, supplied in a carton box 20 (1x20) tablets in a PVC/Al blister, supplied in a box 30 (3x10) film coated tablets in a blister (OPA/Al/PVC//Al), supplied in a box 31 (3x10) film coated tablets in a blister (OPA/Al/PVC//Al), supplied in a box 32 (3x10) film coated tablets in a blister (OPA/Al/PVC//Al), supplied in a box 50 (5x10) capsules in a blister (PVC/Al), supplied in a box 50 (5x10) capsules in a blister (PVC/Al), supplied in a box Plastic bag for 2000 mL of blend (in three separate compartments) in a plastic protective casing, 4 bags in a box Plastic bag with 1000 mL of blend (in three separate compartments) in a plastic protective casing, 6 bags in a carton box Plastic bag for 2000 mL of blend (in three separate compartments) in a plastic protective casing, 4 bags in a box 14509/11 WS/jj 340 ANNEX II DGF 2A / DG K 2 EN 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
OliClinomel N7 - 1000 E emulsion for infusion OliClinomel N7 - 1000 E emulsion for infusion Olivin 10 mg tablets tablets Olivin 20 mg tablets tablets Olivin 5 mg tablets tablets Olynth 0.05% nasal spray nasal spray, solution Olynth 0.1% nasal drops nasal drops, solution Olynth 0.1% nasal spray nasal spray, solution Olynth 0.5% nasal drops nasal drops, solution Olynth HA 0.05% nasal spray Olynth HA 0.1% nasal spray Omacor nasal spray, solution nasal spray, solution capsules (soft, transparent, gelatinous) Omegaven emulsion for infusion Omegaven emulsion for infusion Omezol capsules 20 mg Omnic 0.4 mg gastric-resistant capsules, hard prolonged-release capsules Clintec Parenteral S.A., France; Baxter S.A., Lessines, Belgium Clintec Parenteral S.A., France; Baxter S.A., Lessines, Belgium Lek farmacevtska družba d.d., Verovškova 57, Ljubljana, Republic of Slovenia Lek farmacevtska družba d.d., Verovškova 57, Ljubljana, Republic of Slovenia Lek farmacevtska družba d.d., Verovškova 57, Ljubljana, Republic of Slovenia Pfizer PGM, Orleans Cedex, France Pfizer PGM, Orleans Cedex, France Pfizer PGM, Orleans Cedex, France Pfizer PGM, Orleans Cedex, France URSAPHARM Arzneimittel GmbH&Co., Saarbrucken, Germany URSAPHARM Arzneimittel GmbH&Co., Saarbrucken, Germany Solvay Pharmaceuticals GmbH, Neustadt, Germany Fresenius Kabi Austria GmbH, Graz, Austria Fresenius Kabi Austria GmbH, Graz, Austria Farmal d.d., Branitelja domovinskog rata 8, Ludbreg, Republic of Croatia Astellas Pharma Europe B.V., Elisabethhof 19, Leiderdorp, the Plastic bag for 2000 mL of blend (in three separate compartments) in a plastic protective casing, 4 bags in a box Plastic bag with 1000 mL of blend (in three separate compartments) in a plastic protective casing, 6 bags in a carton box 20 (2x10) tablets in a blister, supplied in a box 20 (2x10) tablets in a blister, supplied in a box 20 (2x10) tablets in a blister, supplied in a box 10 mL of solution in an amber glass bottle with a plastic atomizer extension and protective cap, supplied in a box 10 mL of solution in an amber glass bottle with dropper, supplied in a box 10 mL of solution in an amber glass bottle with a plastic atomizer extension and protective cap, supplied in a box 10 mL of solution in an amber glass bottle with dropper, supplied in a box 10 mL of solution in a white plastic bottle with a 3K system and protective cap, supplied in a box 10 mL of solution in a white plastic bottle with a 3K system and protective cap, supplied in a box 28 capsules in a plastic bottle 10 glass bottles with 100 mL of emulsion (10x100 mL), supplied in a box 10 glass bottles with 50 mL of emulsion (10x50 mL), supplied in a box 14 (2x7) capsules in a OPA/Al/PVC//Al blister, supplied in a box Box with 3x10 prolonged release capsules in an Al/polypropylene blister 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 341 ANNEX II DGF 2A / DG K 2 EN
Page 1 and 2:
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
Page 223 and 224:
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
Page 235 and 236:
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
Page 247 and 248:
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
Page 253 and 254:
Ciprinol film coated tablets 500 mg
Page 255 and 256:
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
Page 261 and 262:
CORTEF tablets 10 mg tablets Coryol
Page 263 and 264:
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
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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 and 320: Losartic tablets 25 mg film coated
Page 321 and 322: LYSOBACT oriblets MabCampath 30 mg/
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: NUROFEN oral suspension for childre
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
Page 373 and 374: SOMAVERT injection 20 mg SOMAVERT i
Page 375 and 376: Stocrin 200 mg capsules capsules ST
Page 377 and 378: Stugeron forte tablets tablets Subu
Page 379 and 380: Symbicort Turbuhaler 320/9 µg Symb
Page 381 and 382: Tantum Verde gargling solution Tant
Page 383 and 384: 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
Page 389 and 390: Tritace 1.25 tablets Tritace 2.5 ta
Page 391 and 392:
Ultravist 370 solution for injectio
Page 393 and 394:
VAXIGRIP Pediatric use - inactivate
Page 395 and 396:
Vincristine injection 1 mg VIRACEPT
Page 397 and 398:
Water for Injections Viaflo diluent
Page 399 and 400:
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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PUBLIC - Croatia, the War, and the Future

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