# Službeni list C 428/28.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 428 |
| | |
| Hrvatsko izdanje | Informacije i objave | Svezak 57.28. studenoga 2014. |

ISSN 1977-1088

Službeni list

Europske unije

C 428

Hrvatsko izdanje

Informacije i objave

Svezak 57.28. studenoga 2014.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2014/C 428/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2014. do 31. listopada 2014.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2014/C 428/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2014. do 31. listopada 2014.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC ili člankom 38. Direktive 2001/82/EC) | 7 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2014/C 428/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2014. do 31. listopada 2014.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

1

2014/C 428/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2014. do 31. listopada 2014.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC ili člankom 38. Direktive 2001/82/EC)

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC ili člankom 38. Direktive 2001/82/EC)

7

| HR | |
| --- | --- |

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 28.11.2014 | HR | Službeni list Europske unije | C 428/1 |
| --- | --- | --- | --- |

28.11.2014

HR

Službeni list Europske unije

C 428/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2014. do 31. listopada 2014.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))

(2014/C 428/01)

—   Izdavanje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.10.2014. | IMBRUVICA | Ibrutinib | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/945 | Kapsula, tvrda | L01XE27 | 23.10.2014. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

21.10.2014.

IMBRUVICA

Ibrutinib

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/945

Kapsula, tvrda

L01XE27

23.10.2014.

—   Izmjena odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 1.10.2014. | Apidra | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/04/285 | 6.10.2014. |
| 1.10.2014. | Bexsero | Novartis Vaccines and Diagnostics S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 3.10.2014. |
| 1.10.2014. | BYDUREON | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/696 | 3.10.2014. |
| 1.10.2014. | ellaOne | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Pariz, France | EU/1/09/522 | 3.10.2014. |
| 1.10.2014. | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Pariz, France | EU/1/98/070 | 3.10.2014. |
| 1.10.2014. | Liprolog | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/01/195 | 3.10.2014. |
| 1.10.2014. | Plavix | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Pariz, France | EU/1/98/069 | 3.10.2014. |
| 1.10.2014. | Voriconazole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/835 | 3.10.2014. |
| 1.10.2014. | Zoledronic acid Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/12/771 | 3.10.2014. |
| 3.10.2014. | Forxiga | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/795 | 7.10.2014. |
| 3.10.2014. | Insuman | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/97/030 | 7.10.2014. |
| 3.10.2014. | Jakavi | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/12/773 | 7.10.2014. |
| 3.10.2014. | Xigduo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/13/900 | 7.10.2014. |
| 8.10.2014. | Krystexxa | Crealta Pharmaceuticals Ireland Limited
  Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland | EU/1/12/810 | 13.10.2014. |
| 8.10.2014. | Tarceva | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311 | 10.10.2014. |
| 8.10.2014. | Yentreve | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/280 | 10.10.2014. |
| 10.10.2014. | Ariclaim | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/283 | 14.10.2014. |
| 10.10.2014. | Evoltra | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/334 | 14.10.2014. |
| 10.10.2014. | Keppra | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/00/146 | 14.10.2014. |
| 10.10.2014. | Translarna | PTC Therapeutics International Limited
  77 Sir John Rogerson’s Quay, Dublin 2, Ireland | EU/1/13/902 | 14.10.2014. |
| 15.10.2014. | Atosiban SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/13/852 | 17.10.2014. |
| 15.10.2014. | Komboglyze | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/731 | 20.10.2014. |
| 15.10.2014. | Onglyza | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/09/545 | 17.10.2014. |
| 15.10.2014. | Xeristar | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/297 | 17.10.2014. |
| 20.10.2014. | Cymbalta | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/296 | 23.10.2014. |
| 21.10.2014. | Clopidogrel Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/561 | 23.10.2014. |
| 22.10.2014. | Lyxumia | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Pariz, France | EU/1/12/811 | 24.10.2014. |
| 22.10.2014. | Nevirapine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/598 | 24.10.2014. |
| 22.10.2014. | Privigen | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/08/446 | 24.10.2014. |
| 27.10.2014. | Abraxane | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/07/428 | 29.10.2014. |
| 27.10.2014. | BindRen | Mitsubishi Tanabe Pharma Europe Ltd.
  Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom | EU/1/12/804 | 29.10.2014. |
| 27.10.2014. | Entacapone Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/665 | 29.10.2014. |
| 27.10.2014. | Fasturtec | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Pariz, France | EU/1/00/170 | 29.10.2014. |
| 27.10.2014. | Hexyon | Sanofi Pasteur MSD, SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/13/829 | 29.10.2014. |
| 27.10.2014. | Invanz | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/02/216 | 29.10.2014. |
| 27.10.2014. | Myclausen | Herbert J. Passauer GmbH & Co. KG
  Stubenrauchstrasse 33, D-14167 Berlin, Deutschland | EU/1/10/647 | 29.10.2014. |
| 27.10.2014. | Synflorix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/09/508 | 29.10.2014. |
| 27.10.2014. | Vidaza | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/08/488 | 29.10.2014. |
| 27.10.2014. | Zavesca | Actelion Registration Ltd
  Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom | EU/1/02/238 | 29.10.2014. |
| 30.10.2014. | Elonva | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/609 | 3.11.2014. |
| 30.10.2014. | Hexacima | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/13/828 | 3.11.2014. |
| 30.10.2014. | Mycophenolate mofetil Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/07/439 | 4.11.2014. |
| 30.10.2014. | Myfenax | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/07/438 | 4.11.2014. |
| 30.10.2014. | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/06/380 | 3.11.2014. |
| 30.10.2014. | Zinforo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/785 | 3.11.2014. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

1.10.2014.

Apidra

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/04/285

6.10.2014.

1.10.2014.

Bexsero

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

3.10.2014.

1.10.2014.

BYDUREON

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/696

3.10.2014.

1.10.2014.

ellaOne

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Pariz, France

EU/1/09/522

3.10.2014.

1.10.2014.

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Pariz, France

EU/1/98/070

3.10.2014.

1.10.2014.

Liprolog

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/01/195

3.10.2014.

1.10.2014.

Plavix

Sanofi Clir SNC

54 rue La Boétie, F-75008 Pariz, France

EU/1/98/069

3.10.2014.

1.10.2014.

Voriconazole Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/13/835

3.10.2014.

1.10.2014.

Zoledronic acid Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/12/771

3.10.2014.

3.10.2014.

Forxiga

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/795

7.10.2014.

3.10.2014.

Insuman

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030

7.10.2014.

3.10.2014.

Jakavi

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/12/773

7.10.2014.

3.10.2014.

Xigduo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/900

7.10.2014.

8.10.2014.

Krystexxa

Crealta Pharmaceuticals Ireland Limited

Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland

EU/1/12/810

13.10.2014.

8.10.2014.

Tarceva

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/05/311

10.10.2014.

8.10.2014.

Yentreve

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/280

10.10.2014.

10.10.2014.

Ariclaim

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/283

14.10.2014.

10.10.2014.

Evoltra

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/334

14.10.2014.

10.10.2014.

Keppra

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/00/146

14.10.2014.

10.10.2014.

Translarna

PTC Therapeutics International Limited

77 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/13/902

14.10.2014.

15.10.2014.

Atosiban SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/13/852

17.10.2014.

15.10.2014.

Komboglyze

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/731

20.10.2014.

15.10.2014.

Onglyza

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/09/545

17.10.2014.

15.10.2014.

Xeristar

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/297

17.10.2014.

20.10.2014.

Cymbalta

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/296

23.10.2014.

21.10.2014.

Clopidogrel Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/561

23.10.2014.

22.10.2014.

Lyxumia

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Pariz, France

EU/1/12/811

24.10.2014.

22.10.2014.

Nevirapine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/598

24.10.2014.

22.10.2014.

Privigen

CSL Behring GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/08/446

24.10.2014.

27.10.2014.

Abraxane

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom

EU/1/07/428

29.10.2014.

27.10.2014.

BindRen

Mitsubishi Tanabe Pharma Europe Ltd.

Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom

EU/1/12/804

29.10.2014.

27.10.2014.

Entacapone Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/665

29.10.2014.

27.10.2014.

Fasturtec

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Pariz, France

EU/1/00/170

29.10.2014.

27.10.2014.

Hexyon

Sanofi Pasteur MSD, SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/13/829

29.10.2014.

27.10.2014.

Invanz

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/02/216

29.10.2014.

27.10.2014.

Myclausen

Herbert J. Passauer GmbH & Co. KG

Stubenrauchstrasse 33, D-14167 Berlin, Deutschland

EU/1/10/647

29.10.2014.

27.10.2014.

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/09/508

29.10.2014.

27.10.2014.

Vidaza

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom

EU/1/08/488

29.10.2014.

27.10.2014.

Zavesca

Actelion Registration Ltd

Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom

EU/1/02/238

29.10.2014.

30.10.2014.

Elonva

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/09/609

3.11.2014.

30.10.2014.

Hexacima

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/13/828

3.11.2014.

30.10.2014.

Mycophenolate mofetil Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/07/439

4.11.2014.

30.10.2014.

Myfenax

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/07/438

4.11.2014.

30.10.2014.

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/06/380

3.11.2014.

30.10.2014.

Zinforo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/785

3.11.2014.

—   Povlačenje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 1.10.2014. | FLUENZ | MedImmune, LLC
  Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | EU/1/10/661 | 3.10.2014. |
| 1.10.2014. | Topotecan Eagle | Eagle Laboratories Limited
  The Clock House, Station Approach, Marlow, Bucks SL7 1NT, United Kingdom | EU/1/11/744 | 3.10.2014. |
| 21.10.2014. | Clopidogrel Teva Pharma B.V. | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/10/649 | 23.10.2014. |
| 27.10.2014. | Ipreziv | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/11/735 | 29.10.2014. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

1.10.2014.

FLUENZ

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/10/661

3.10.2014.

1.10.2014.

Topotecan Eagle

Eagle Laboratories Limited

The Clock House, Station Approach, Marlow, Bucks SL7 1NT, United Kingdom

EU/1/11/744

3.10.2014.

21.10.2014.

Clopidogrel Teva Pharma B.V.

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/10/649

23.10.2014.

27.10.2014.

Ipreziv

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/11/735

29.10.2014.

—   Izmjena odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 21.10.2014. | Loxicom | Norbrook Laboratories Ltd
  Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | EU/2/08/090 | 23.10.2014. |
| 27.10.2014. | Apoquel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/13/154 | 29.10.2014. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

21.10.2014.

Loxicom

Norbrook Laboratories Ltd

Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

EU/2/08/090

23.10.2014.

27.10.2014.

Apoquel

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/13/154

29.10.2014.

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

| The European Medicines Agency |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK – LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK – LONDON E14 5EU

---

(1)  SL L 136, 30.4.2004., str. 1.

---

| 28.11.2014 | HR | Službeni list Europske unije | C 428/7 |
| --- | --- | --- | --- |

28.11.2014

HR

Službeni list Europske unije

C 428/7

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2014. do 31. listopada 2014.

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC (1) ili člankom 38. Direktive 2001/82/EC (2))

(2014/C 428/02)

—   Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj(i) odobrenja za stavljanje u promet | Država clanica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 30.10.2014. | Bromocriptine | Vidjeti Prilog I | Vidjeti Prilog I | Vidjeti Prilog I | 3.11.2014. |

Datum odluke

Naziv(i) lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država clanica na koju se odnosi

Datum obavijesti

30.10.2014.

Bromocriptine

Vidjeti Prilog I

Vidjeti Prilog I

Vidjeti Prilog I

3.11.2014.

---

(1)  SL L 311, 28.11.2001., str. 67.

(2)  SL L 311, 28.11.2001., str. 1.

---

DODATAK I

Popis imena, farmaceutskih oblika, jačina lijekova, puta primjene, nositelja odobrenja u zemljama članicama

| Država članica
  (u EGP) | Nositelj odobrenja | Zaštićeno ime | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Austrija | Meda Pharma GmbH
  Guglgasse 15/II. Stock 1110
  Wien
  Austria | Parlodel 2,5 mg – Tabletten | 2,5 mg | tableta | kroz usta |
| Belgija | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel | 2,5 mg | tableta | kroz usta |
| Belgija | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel 5 mg | 5 mg | kapsula, tvrda | kroz usta |
| Belgija | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel 10 mg | 10 mg | kapsula, tvrda | kroz usta |
| Bugarska | Sopharma AD
  16 „Iliensko shose” Str.
  Sofia 1220
  Bulgaria | Bromocriptine Sopharma | 2,5 mg | tableta | kroz usta |
| Bugarska | Medochemie Ltd.
  1-10 Astronafton Str.
  Limassol 3505
  Cyprus | Medocriptine | 2,5 mg | tableta | kroz usta |
| Hrvatska | Sandoz d.o.o.
  Maksimirska 120/V
  Zagreb 10  000
  Croatia | Bromergon 2,5 mg tablete | 2,5 mg | tableta | kroz usta |
| Cipar | Codal Synto Ltd
  33 Theklas Lysioti street
  Dorothea Building, 6th floor
  Lemesos 3508 Cyprus | Pirodal | 2,5 mg | tableta | kroz usta |
| Cipar | Remedica Ltd Aharnon Street
  Limassol Industrial Estate
  Lemesos 3508 Cyprus | Brameston | 2,5 mg | tableta | kroz usta |
| Cipar | Medochemie Ltd Constantinoupoleos 1-10 Street
  Lemesos 3501 Cyprus | Medocriptine | 2,5 mg | tableta | kroz usta |
| Češka | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  110 00 Prague 10
  Czech Republic | Parlodel | 2,5 mg | tableta | kroz usta |
| Češka | Medochemie Ltd.
  Constantinoupoleos Str. 1_10
  3011 Limassol – Tsiflikoudia
  Cyprus | Medocriptine | 2,5 mg | tableta | kroz usta |
| Danska | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 10 mg | kapsula, tvrda | kroz usta |
| Danska | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 5 mg | kapsula, tvrda | kroz usta |
| Danska | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 2,5 mg | tableta | kroz usta |
| Estonija | Gedeon Richter Plc.
  Gyömrõi ut 19-21
  1103 Budapest
  Hungary | BROMOCRIPTIN-RICHTER | 2,5 mg | tableta | kroz usta |
| Finska | Meda Oy
  Vaisalantie 4
  02130 Espoo
  Finland | PARLODEL | 2,5 mg | tableta | kroz usta |
| Francuska | MEDA PHARMA
  25, boulevard de l'Amiral Bruix 75016 Paris
  France | PARLODEL 2,5 mg inhibition de la lactation | 2,5 mg | tableta | kroz usta |
| Francuska | SANOFI AVENTIS FRANCE
  1-13 boulevard Romain Rolland
  75014 PARIS
  France | BROMOCRIPTINE ZENTIVA 2,5 mg lNHIBITION DE LA LACTATION | 2,5 mg | tableta | kroz usta |
| Njemačka | AbZ-Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Bromocriptin AbZ 2,5 mg | 2,5 mg | tableta | kroz usta |
| Njemačka | Betapharm Arzneimittel GmbH
  Kobelweg 95
  86156 Augsburg
  Germany | Bromocriptin beta 2,5 | 2,5 mg | tableta | kroz usta |
| Njemačka | AbZ-Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | bromocriptin-ct 2,5 mg Tabletten | 2,5 mg | tableta | kroz usta |
| Njemačka | Hexal AG
  Industriestr. 25
  83607 Holzkirchen
  Germany | Bromocriptin HEXAL 2,5 mg Tabletten | 2,5 mg | tableta | kroz usta |
| Njemačka | MEDA Pharma GmbH & Co. KG
  Benzstr. 1
  61352 Bad Homburg
  Germany | Pravidel 2,5 mg Tabletten | 2,5 mg | tableta | kroz usta |
| Njemačka | Ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Bromocriptin-ratiopharm 2,5 mg Tabletten | 2,5 mg | tableta | kroz usta |
| Grčka | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 2,5 mg | tableta | kroz usta |
| Grčka | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 5 mg | kapsula, tvrda | kroz usta |
| Grčka | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 10 mg | kapsula, tvrda | kroz usta |
| Mađarska | Gedeon Richter Plc
  Gyömrői út 19-21
  H-1103 Budapest
  Hungary | Bromocriptin-Richter 2,5 mg tabletta | 2,5 mg | tableta | kroz usta |
| Irska | Meda Health Sales Ireland Limited
  Unit 34/35, Block A
  Dunboyne Business Park
  Dunboyne Co. Meath
  Ireland | Parlodel 2,5 mg Tablets | 2,5 mg | tableta | kroz usta |
| Irska | Meda Health Sales Ireland Limited
  Unit 34/35, Block A
  Dunboyne Business Park
  Dunboyne Co. Meath
  Ireland | Parlodel 5 mg Hard Capsules | 5 mg | kapsula, tvrda | kroz usta |
| Litva | Gedeon Richter Plc.
  Gyömröi út 19-21
  1103 Budapest
  Hungary | BROMOCRIPTIN-RICHTER | 2,5 mg | tableta | kroz usta |
| Luksemburg | MEDA Pharma GmbH & Co. KG
  Benzstraße 1
  61352 Bad Homburg
  Germany | Pravidel | 2,5 mg | tableta | kroz usta |
| Norveška | Meda AS
  Askerveien 61
  Postboks 194
  1371 Asker
  Norway | Parlodel | 2,5 mg | tableta | kroz usta |
| Poljska | Sandoz GmbH
  Biochemiestrasse 10
  Kundl
  6250 Tyrol
  Austria | Bromergon | 2,5 mg | tableta | kroz usta |
| Poljska | Farmaceutyczna Spółdzielnia Pracy FILOFARM
  ul. Pułaskiego 39
  85-619 Bydgoszcz
  Poland | Bromocorn | 2,5 mg | tableta | kroz usta |
| Poljska | Meda Aktiebolag
  Pipers vag 2
  170 09 Solna
  Box 906
  Sweden | Parlodel | 2,5 mg | tableta | kroz usta |
| Portugal | Meda Pharma – Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Parlodel | 5 mg | kapsula | kroz usta |
| Portugal | Meda Pharma – Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Parlodel | 10 mg | kapsula | kroz usta |
| Portugal | Meda Pharma – Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Parlodel | 2,5 mg | tableta | kroz usta |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Bromocriptina Generis 2,5 mg comprimidos | 2,5 mg | tableta | kroz usta |
| Rumunjska | S.C. BIOFARM S.A.
  Str. Logofăt Tăutu nr. 99
  sector 3, Bucureşti
  031212
  Romania | BROMOCRIPTIN | 2,5 mg | obložena tableta | kroz usta |
| Slovačka | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  100 00 Praha 10
  Czech Republic | Parlodel | 2,5 mg | tableta | kroz usta |
| Slovačka | Medochemie Ltd.
  1-10 Constantinoupoleos St.
  3011 Limassol
  Cyprus | MEDOCRIPTINE 2,5 mg | 2,5 mg | tableta | kroz usta |
| Slovenija | Lek farmacevtska družba d.d. Verovškova 57
  1526 Ljubljana Slovenia | Bromergon 2,5 mg tablete | 2,5 mg | tableta | kroz usta |
| Španjolska | MEDA PHARMA, S.A.U. Avda. Castilla 2
  Edificio Berlín 2a planta
  Parque Empresarial San Fernando 28830 San Fernando de Henares Madrid
  Spain | Parlodel 2,5 mg comprimidos | 2,5 mg | tableta | kroz usta |
| Švedska | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 2,5 mg | tableta | kroz usta |
| Švedska | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 10 mg | kapsula, tvrda | kroz usta |
| Švedska | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 5 mg | kapsula, tvrda | kroz usta |
| Nizozemska | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 10 mg capsules | 10 mg | kapsula, tvrda | kroz usta |
| Nizozemska | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 2,5 mg | 2,5 mg | tableta | kroz usta |
| Nizozemska | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 5 mg capsules | 5 mg | kapsula, tvrda | kroz usta |
| Ujedinjeno Kraljevstvo | Teva UK Limited
  Brampton Road, Hampden Park Eastbourne, East Sussex
  BN22 9AG
  United Kingdom | Teva UK Bromocriptine Tablets | 2,5 mg | tableta | kroz usta |
| Ujedinjeno Kraljevstvo | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road
  Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 1 mg Tablets | 1 mg | tableta | kroz usta |
| Ujedinjeno Kraljevstvo | Meda Pharmaceuticals Limited
  Skyway House, Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 2,5 mg Tablets | 2,5 mg | tableta | kroz usta |
| Ujedinjeno Kraljevstvo | Meda Pharmaceuticals Limited
  Skyway House, Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 5 mg Tablets | 5 mg | kapsula | kroz usta |
| Ujedinjeno Kraljevstvo | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 10 mg Tablets | 10 mg | kapsula | kroz usta |
| Ujedinjeno Kraljevstvo | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Bromocriptine 1 mg Tablets | 1 mg | tableta | kroz usta |
| Ujedinjeno Kraljevstvo | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Bromocriptine 2,5 mg Tablets | 2,5 mg | tableta | kroz usta |

Država članica

(u EGP)

Nositelj odobrenja

Zaštićeno ime

Jačina

Farmaceutski oblik

Put primjene

Austrija

Meda Pharma GmbH

Guglgasse 15/II. Stock 1110

Wien

Austria

Parlodel 2,5 mg – Tabletten

2,5 mg

tableta

kroz usta

Belgija

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel

2,5 mg

tableta

kroz usta

Belgija

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel 5 mg

5 mg

kapsula, tvrda

kroz usta

Belgija

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel 10 mg

10 mg

kapsula, tvrda

kroz usta

Bugarska

Sopharma AD

16 „Iliensko shose” Str.

Sofia 1220

Bulgaria

Bromocriptine Sopharma

2,5 mg

tableta

kroz usta

Bugarska

Medochemie Ltd.

1-10 Astronafton Str.

Limassol 3505

Cyprus

Medocriptine

2,5 mg

tableta

kroz usta

Hrvatska

Sandoz d.o.o.

Maksimirska 120/V

Zagreb 10  000

Croatia

Bromergon 2,5 mg tablete

2,5 mg

tableta

kroz usta

Cipar

Codal Synto Ltd

33 Theklas Lysioti street

Dorothea Building, 6th floor

Lemesos 3508 Cyprus

Pirodal

2,5 mg

tableta

kroz usta

Cipar

Remedica Ltd Aharnon Street

Limassol Industrial Estate

Lemesos 3508 Cyprus

Brameston

2,5 mg

tableta

kroz usta

Cipar

Medochemie Ltd Constantinoupoleos 1-10 Street

Lemesos 3501 Cyprus

Medocriptine

2,5 mg

tableta

kroz usta

Češka

MEDA Pharma s.r.o.

Kodaňská 1441/46

110 00 Prague 10

Czech Republic

Parlodel

2,5 mg

tableta

kroz usta

Češka

Medochemie Ltd.

Constantinoupoleos Str. 1_10

3011 Limassol – Tsiflikoudia

Cyprus

Medocriptine

2,5 mg

tableta

kroz usta

Danska

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

10 mg

kapsula, tvrda

kroz usta

Danska

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

5 mg

kapsula, tvrda

kroz usta

Danska

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

2,5 mg

tableta

kroz usta

Estonija

Gedeon Richter Plc.

Gyömrõi ut 19-21

1103 Budapest

Hungary

BROMOCRIPTIN-RICHTER

2,5 mg

tableta

kroz usta

Finska

Meda Oy

Vaisalantie 4

02130 Espoo

Finland

PARLODEL

2,5 mg

tableta

kroz usta

Francuska

MEDA PHARMA

25, boulevard de l'Amiral Bruix 75016 Paris

France

PARLODEL 2,5 mg inhibition de la lactation

2,5 mg

tableta

kroz usta

Francuska

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 PARIS

France

BROMOCRIPTINE ZENTIVA 2,5 mg lNHIBITION DE LA LACTATION

2,5 mg

tableta

kroz usta

Njemačka

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Bromocriptin AbZ 2,5 mg

2,5 mg

tableta

kroz usta

Njemačka

Betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Bromocriptin beta 2,5

2,5 mg

tableta

kroz usta

Njemačka

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

bromocriptin-ct 2,5 mg Tabletten

2,5 mg

tableta

kroz usta

Njemačka

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Bromocriptin HEXAL 2,5 mg Tabletten

2,5 mg

tableta

kroz usta

Njemačka

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Pravidel 2,5 mg Tabletten

2,5 mg

tableta

kroz usta

Njemačka

Ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Bromocriptin-ratiopharm 2,5 mg Tabletten

2,5 mg

tableta

kroz usta

Grčka

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

2,5 mg

tableta

kroz usta

Grčka

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

5 mg

kapsula, tvrda

kroz usta

Grčka

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

10 mg

kapsula, tvrda

kroz usta

Mađarska

Gedeon Richter Plc

Gyömrői út 19-21

H-1103 Budapest

Hungary

Bromocriptin-Richter 2,5 mg tabletta

2,5 mg

tableta

kroz usta

Irska

Meda Health Sales Ireland Limited

Unit 34/35, Block A

Dunboyne Business Park

Dunboyne Co. Meath

Ireland

Parlodel 2,5 mg Tablets

2,5 mg

tableta

kroz usta

Irska

Meda Health Sales Ireland Limited

Unit 34/35, Block A

Dunboyne Business Park

Dunboyne Co. Meath

Ireland

Parlodel 5 mg Hard Capsules

5 mg

kapsula, tvrda

kroz usta

Litva

Gedeon Richter Plc.

Gyömröi út 19-21

1103 Budapest

Hungary

BROMOCRIPTIN-RICHTER

2,5 mg

tableta

kroz usta

Luksemburg

MEDA Pharma GmbH & Co. KG

Benzstraße 1

61352 Bad Homburg

Germany

Pravidel

2,5 mg

tableta

kroz usta

Norveška

Meda AS

Askerveien 61

Postboks 194

1371 Asker

Norway

Parlodel

2,5 mg

tableta

kroz usta

Poljska

Sandoz GmbH

Biochemiestrasse 10

Kundl

6250 Tyrol

Austria

Bromergon

2,5 mg

tableta

kroz usta

Poljska

Farmaceutyczna Spółdzielnia Pracy FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

Bromocorn

2,5 mg

tableta

kroz usta

Poljska

Meda Aktiebolag

Pipers vag 2

170 09 Solna

Box 906

Sweden

Parlodel

2,5 mg

tableta

kroz usta

Portugal

Meda Pharma – Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Parlodel

5 mg

kapsula

kroz usta

Portugal

Meda Pharma – Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Parlodel

10 mg

kapsula

kroz usta

Portugal

Meda Pharma – Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Parlodel

2,5 mg

tableta

kroz usta

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Bromocriptina Generis 2,5 mg comprimidos

2,5 mg

tableta

kroz usta

Rumunjska

S.C. BIOFARM S.A.

Str. Logofăt Tăutu nr. 99

sector 3, Bucureşti

031212

Romania

BROMOCRIPTIN

2,5 mg

obložena tableta

kroz usta

Slovačka

MEDA Pharma s.r.o.

Kodaňská 1441/46

100 00 Praha 10

Czech Republic

Parlodel

2,5 mg

tableta

kroz usta

Slovačka

Medochemie Ltd.

1-10 Constantinoupoleos St.

3011 Limassol

Cyprus

MEDOCRIPTINE 2,5 mg

2,5 mg

tableta

kroz usta

Slovenija

Lek farmacevtska družba d.d. Verovškova 57

1526 Ljubljana Slovenia

Bromergon 2,5 mg tablete

2,5 mg

tableta

kroz usta

Španjolska

MEDA PHARMA, S.A.U. Avda. Castilla 2

Edificio Berlín 2a planta

Parque Empresarial San Fernando 28830 San Fernando de Henares Madrid

Spain

Parlodel 2,5 mg comprimidos

2,5 mg

tableta

kroz usta

Švedska

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

2,5 mg

tableta

kroz usta

Švedska

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

10 mg

kapsula, tvrda

kroz usta

Švedska

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

5 mg

kapsula, tvrda

kroz usta

Nizozemska

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 10 mg capsules

10 mg

kapsula, tvrda

kroz usta

Nizozemska

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 2,5 mg

2,5 mg

tableta

kroz usta

Nizozemska

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 5 mg capsules

5 mg

kapsula, tvrda

kroz usta

Ujedinjeno Kraljevstvo

Teva UK Limited

Brampton Road, Hampden Park Eastbourne, East Sussex

BN22 9AG

United Kingdom

Teva UK Bromocriptine Tablets

2,5 mg

tableta

kroz usta

Ujedinjeno Kraljevstvo

Meda Pharmaceuticals Limited

Skyway House Parsonage Road

Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 1 mg Tablets

1 mg

tableta

kroz usta

Ujedinjeno Kraljevstvo

Meda Pharmaceuticals Limited

Skyway House, Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 2,5 mg Tablets

2,5 mg

tableta

kroz usta

Ujedinjeno Kraljevstvo

Meda Pharmaceuticals Limited

Skyway House, Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 5 mg Tablets

5 mg

kapsula

kroz usta

Ujedinjeno Kraljevstvo

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 10 mg Tablets

10 mg

kapsula

kroz usta

Ujedinjeno Kraljevstvo

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Bromocriptine 1 mg Tablets

1 mg

tableta

kroz usta

Ujedinjeno Kraljevstvo

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Bromocriptine 2,5 mg Tablets

2,5 mg

tableta

kroz usta

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