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TARKA 240 mg/2 mg tablets TARKA 240 mg/4 mg tablets Tavanic 250 mg tablets film tablets Tavanic 500 mg tablets film tablets Tavanic i.v. 500 mg Taxol injection 100 mg / 16.7 mL Taxol injection 30 mg / 5 mL Taxol injection 300 mg / 50 mL Taxotere 20 mg Taxotere 80 mg Tazocin 4.5 g injection for intravenous use modified-release tablets modified-release tablets solution for intravenous infusion concentrate for solution for infusion concentrate for solution for infusion concentrate for solution for infusion concentrate for solution for infusion concentrate for solution for infusion powder for preparation of solution for injection or infusion Telebrix 35 solution for injection Telfast 120 mg film coated tablets Telfast 180 mg film coated tablets Telfast 30 mg film coated tablets Germany (PVC/PVDC//Al) , supplied in Abbott GmbH & Co.KG., Ludwigshafen, Germany Abbott GmbH & Co.KG., Ludwigshafen, Germany Aventis Pharma Deutschland GmbH, Brunningstrasse 50, Frankfurt am Main, Germany Aventis Pharma Deutschland GmbH, Brunningstrasse 50, Frankfurt am Main, Germany Aventis Pharma Deutschland GmbH, Brunningstrasse 50, Frankfurt am Main, Germany Bristol Myers-Squibb S.r.I., Sermoneta, Latina, Italy Bristol Myers-Squibb S.r.I., Sermoneta, Latina, Italy Bristol Myers-Squibb S.r.I., Sermoneta, Latina, Italy Aventis Pharma Dagenham, Dagenham, Essex, Great Britain Aventis Pharma Dagenham, Dagenham, Essex, Great Britain Wyeth Lederle S.p.A., Catania, Italy; Wyeth Laboratories, New Lane, Havant, Great Britain Guerbet, Cedex, France Aventis Pharma Deutschland GmbH, Brunningstrasse 50, Frankfurt am Main, Germany Aventis Pharma Deutschland GmbH, Brunningstrasse 50, Frankfurt am Main, Germany Aventis Pharma S.p.A., S.S. 17 KM 22, Scoppito, Italy a box 28 (2x14) modified-release tablets in a blister (PVC/PVDC//Al) , supplied in a box 28 (2x14) modified-release tablets in a blister (PVC/PVDC//Al) , supplied in a box 10 tablets in a blister, supplied in a box 10 tablets in a blister, supplied in a box 100 mL of solution in a glass bottle, supplied in a box One glass vial with 16.7 mL of solution concentrate, supplied in a carton box One glass vial with 5 mL of solution concentrate, supplied in a carton box One glass vial with 50 mL of solution concentrate, supplied in a carton box One glass vial with 0.5 mL of concentrate and one glass vial containing 1.5 mL of diluent in a blister, supplied in a box One glass vial with 2 mL of concentrate and one glass vial with 6mL of diluent in a blister, supplied in a box Clear glass 72-mL bottle with 4.5 g of lyophilisate equipped with a grey bromobutyl stopper and flip-off cap of aluminum and plastic coloured pink, supplied in a box Vial with 50 mL of solution, supplied in a box 10 tablets in a blister, supplied in a box 10 tablets in a blister, supplied in a box 60 (4x15) tablets in a blister, 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 14509/11 WS/jj 382 ANNEX II DGF 2A / DG K 2 EN
Temodal capsules 100 mg capsules, hard Temodal capsules 20 mg capsules, hard Temodal capsules 250 mg capsules, hard Temodal capsules 5 mg capsules, hard Tenicef 0.5 g injection Tenicef 1g injection Tenicef 2g injection powder for preparation of solution for i.v. and i.m. injection powder for preparation of solution for i.v. and i.m. injection powder for preparation of injection/infusion solution for i.v. use Tenormin 100 mg tablets film coated tablets Tenormin 50 mg tablets film coated tablets Tenox 10 mg tablets tablets Tenox 5 mg tablets tablets Teolin retard 125 mg tablets Teolin retard 300 mg tablets Teotard 200 mg prolonged-release capsules Teotard capsules prolonged-release 350 mg prolonged-release tablets prolonged-release tablets prolonged-release capsules, hard prolonged-release capsules, hard Tertensif film coated tablets Schering-Plough Labo N.V. Industrepark 30, Heist-op-den-Berg, Belgium Schering-Plough Labo N.V. Industrepark 30, Heist-op-den-Berg, Belgium Schering-Plough Labo N.V. Industrepark 30, Heist-op-den-Berg, Belgium Schering-Plough Labo N.V. Industrepark 30, Heist-op-den-Berg, Belgium Pliva Krakow, Krakow, Poland Pliva Krakow, Krakow, Poland Pliva Krakow, Krakow, Poland AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, Great Britain AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, Great Britain Krka d.d., Novo Mesto, Republic of Slovenia; Krka Farma d.o.o., DPC Jastrebarsko, Republic of Croatia Krka d.d., Novo Mesto, Republic of Slovenia; Krka Farma d.o.o., DPC Jastrebarsko, Republic of Croatia Lek farmacevtska družba d.d., Ljubljana, Republic of Slovenia Lek farmacevtska družba d.d., Ljubljana, Republic of Slovenia Krka d.d., Novo mesto, Šmarješka cesta 6, Republic of Slovenia in cooperation with Astellas Pharma GmbH, Germany Krka d.d., Novo mesto, Šmarješka cesta 6, Republic of Slovenia in cooperation with Astellas Pharma GmbH, Germany Les Laboratories Servier Industrie, 905 route de Saran, 45520 Gidy, France 5 capsules in a glass bottle with a plastic stopper, supplied in a box 5 capsules in a glass bottle with a plastic stopper, supplied in a box 5 capsules in a glass bottle with a plastic stopper, supplied in a box 5 capsules in a glass bottle with a plastic stopper, supplied in a box 5 (10 mL) glass bottles with powder, supplied in a box 5 (15 mL) glass bottles with powder, supplied in a box 5 (15 mL) glass bottles with powder, supplied in a box 28 (2x14) film coated tablets in a blister (PVC/PVDC//Al), supplied in a box 29 (2x14) film coated tablets in a blister (PVC/PVDC//Al), supplied in a box 30 (3x10) tablets in a blister, supplied in a box 30 (3x10) tablets in a blister, supplied in a box 40 tablets in a glass bottle, supplied in a carton box 40 (4x10) tablets in a PVC/Al blister, supplied in a carton box 40 (4x10) capsules in a blister (PVC/Al), supplied in a box 40 (4x10) capsules in a blister (PVC/Al), supplied in a box 30 (1x30) tablets in a PVC/Alu blister , 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 14509/11 WS/jj 383 ANNEX II DGF 2A / DG K 2 EN
Page 1 and 2:
Conseil UE COUNCIL OF THE EUROPEAN
Page 3 and 4:
TABLE OF CONTENTS A. Treaty between
Page 5 and 6:
Annex IV: List referred to in Artic
Page 7 and 8:
FINAL ACT I. Text of the Final Act.
Page 9 and 10:
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
Page 19 and 20:
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
Page 55 and 56:
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
Page 81 and 82:
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
Page 105 and 106:
(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
Page 117 and 118:
30. Annex III is replaced by the fo
Page 119 and 120:
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
Page 137 and 138:
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
Page 159 and 160:
7. TRANSPORT POLICY 1. 31992 R 3577
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Member States that apply the transi
Page 163 and 164:
(b) the international transport of
Page 165 and 166:
(ii) By way of derogation from Arti
Page 167 and 168:
(xiv) By way of derogation from poi
Page 169 and 170:
Croatia shall ensure a gradual redu
Page 171 and 172:
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
Page 181 and 182:
20. PURIS, poljoprivredna, prehramb
Page 183 and 184:
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
Page 189 and 190:
G. Modernisation of agricultural ho
Page 191 and 192:
ANNEX VIII Commitments undertaken b
Page 193 and 194:
Any subsequent change to these plan
Page 195 and 196:
− the overall production limitati
Page 197 and 198:
PROTOCOL on certain arrangements co
Page 199 and 200:
The AAUs to be transferred shall be
Page 201 and 202:
1. The Plenipotentiaries of: I. TEX
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Assembled at [city to be inserted]
Page 205 and 206:
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
Page 213 and 214:
[C.] JOINT DECLARATION BY THE PRESE
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III. EXCHANGE OF LETTERS between th
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ANNEX Information and consultation
Page 219 and 220:
13. Certain non-preferential agreem
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NAME OF THE MEDICINAL PRODUCT 1M po
Page 223 and 224:
Agrippal vaccine against influenza
Page 225 and 226:
Alomax 5% dermal solution Alomide 1
Page 227 and 228:
AmLodipin Cipla 10 mg tablets AmLod
Page 229 and 230:
Angal lozenges lozenges Angal S ora
Page 231 and 232:
Aranesp 40 micrograms of solution f
Page 233 and 234:
Asentra 50 mg film coated tablets A
Page 235 and 236:
Atropini sulfas 1 mg/mL injection A
Page 237 and 238:
Balance 1.5% glucose, 1.75 mmol/l c
Page 239 and 240:
Belosalic lotion lotion Belosalic o
Page 241 and 242:
Bilobil forte capsules 80 mg capsul
Page 243 and 244:
Brinerdin coated tablets coated tab
Page 245 and 246:
Canesten 3 vaginal tablets 0.2 g Ca
Page 247 and 248:
CAPD/DPCA 2 sleep safe CAPD/DPCA 2
Page 249 and 250:
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
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
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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 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
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: Tantum Verde gargling solution Tant
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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