# Official Journal C 428/28 N

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 428 |
| | |
| English edition | Information and Notices | Volume 5728 November 2014 |

ISSN 1977-091X

Official Journal

of the European Union

C 428

English edition

Information and Notices

Volume 5728 November 2014

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 428/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 2014(published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2014/C 428/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2014 to 31 October 2014(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 7 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 428/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 2014(published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2014/C 428/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2014 to 31 October 2014(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

7

| EN | |
| --- | --- |

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.11.2014 | EN | Official Journal of the European Union | C 428/1 |
| --- | --- | --- | --- |

28.11.2014

EN

Official Journal of the European Union

C 428/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 2014

(published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2014/C 428/01)

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.10.2014 | IMBRUVICA | Ibrutinib | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/945 | Capsule, hard | L01XE27 | 23.10.2014 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

21.10.2014

IMBRUVICA

Ibrutinib

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/945

Capsule, hard

L01XE27

23.10.2014

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 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 Paris, France | EU/1/09/522 | 3.10.2014 |
| 1.10.2014 | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, 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 Paris, 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 Paris, 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 Paris, 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 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

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 Paris, France

EU/1/09/522

3.10.2014

1.10.2014

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, 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 Paris, 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 Paris, 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 Paris, 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

—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 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 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

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

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 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 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

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

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| 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)  OJ L 136, 30.4.2004, p. 1.

---

| 28.11.2014 | EN | Official Journal of the European Union | C 428/7 |
| --- | --- | --- | --- |

28.11.2014

EN

Official Journal of the European Union

C 428/7

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2014 to 31 October 2014

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2014/C 428/02)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 30.10.2014 | Bromocriptine | See Annex I | See Annex I | See Annex I | 3.11.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

30.10.2014

Bromocriptine

See Annex I

See Annex I

See Annex I

3.11.2014

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States

| Member State
  in EEA | Marketing authorisation holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Meda Pharma GmbH
  Guglgasse 15/II. Stock 1110
  Wien
  Austria | Parlodel 2,5 mg — Tabletten | 2.5 mg | tablet | oral use |
| Belgium | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel | 2.5 mg | tablet | oral use |
| Belgium | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel 5 mg | 5 mg | capsule, hard | oral use |
| Belgium | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel 10 mg | 10 mg | capsule, hard | oral use |
| Bulgaria | Sopharma AD
  16 ‘Iliensko shose’ Str.
  Sofia 1220
  Bulgaria | Bromocriptine Sopharma | 2.5 mg | tablet | oral use |
| Bulgaria | Medochemie Ltd.
  1-10 Astronafton Str.
  Limassol 3505
  Cyprus | Medocriptine | 2.5 mg | tablet | oral use |
| Croatia | Sandoz d.o.o.
  Maksimirska 120/V
  Zagreb 10  000
  Croatia | Bromergon 2,5 mg tablete | 2.5 mg | tablet | oral use |
| Cyprus | Codal Synto Ltd
  33 Theklas Lysioti street Dorothea Building, 6th floor
  Lemesos 3508
  Cyprus | Pirodal | 2.5 mg | tablet | oral use |
| Cyprus | Remedica Ltd Aharnon Street
  Limassol Industrial Estate
  Lemesos 3508 Cyprus | Brameston | 2.5 mg | tablet | oral use |
| Cyprus | Medochemie Ltd Constantinoupoleos 1-10 Street
  Lemesos 3501 Cyprus | Medocriptine | 2.5 mg | tablet | oral use |
| Czech Republic | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  110 00 Prague 10
  Czech Republic | Parlodel | 2.5 mg | tablet | oral use |
| Czech Republic | Medochemie Ltd.
  Constantinoupoleos Str. 1-10
  3011 Limassol — Tsiflikoudia
  Cyprus | Medocriptine | 2.5 mg | tablet | oral use |
| Denmark | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 10 mg | capsule, hard | oral use |
| Denmark | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 5 mg | capsule, hard | oral use |
| Denmark | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 2.5 mg | tablet | oral use |
| Estonia | Gedeon Richter Plc.
  Gyömrõi ut 19-21
  1103 Budapest
  Hungary | BROMOCRIPTIN-RICHTER | 2.5 mg | tablet | oral use |
| Finland | Meda Oy
  Vaisalantie 4
  02130 Espoo
  Finland | PARLODEL | 2.5 mg | tablet | oral use |
| France | MEDA PHARMA
  25, boulevard de l'Amiral Bruix 75016 Paris
  France | PARLODEL 2,5 mg inhibition de la lactation | 2.5 mg | tablet | oral use |
| France | SANOFI AVENTIS FRANCE
  1-13 boulevard Romain Rolland
  75014 PARIS
  France | BROMOCRIPTINE ZENTIVA 2,5 mg lNHIBITION DE LA LACTATION | 2.5 mg | tablet | oral use |
| Germany | AbZ-Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Bromocriptin AbZ 2,5 mg | 2.5 mg | tablet | oral use |
| Germany | Betapharm Arzneimittel GmbH
  Kobelweg 95
  86156 Augsburg
  Germany | Bromocriptin beta 2,5 | 2.5 mg | tablet | oral use |
| Germany | AbZ-Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | bromocriptin-ct 2,5 mg Tabletten | 2.5 mg | tablet | oral use |
| Germany | Hexal AG
  Industriestr. 25
  83607 Holzkirchen
  Germany | Bromocriptin HEXAL 2,5 mg Tabletten | 2.5 mg | tablet | oral use |
| Germany | MEDA Pharma GmbH & Co. KG
  Benzstr. 1
  61352 Bad Homburg
  Germany | Pravidel 2,5 mg Tabletten | 2.5 mg | tablet | oral use |
| Germany | Ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Bromocriptin-ratiopharm 2,5 mg Tabletten | 2.5 mg | tablet | oral use |
| Greece | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 2.5 mg | tablet | oral use |
| Greece | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 5 mg | capsule, hard | oral use |
| Greece | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 10 mg | capsule, hard | oral use |
| Hungary | Gedeon Richter Plc
  Gyömrői út 19-21
  H-1103 Budapest
  Hungary | Bromocriptin-Richter 2,5 mg tabletta | 2.5 mg | tablet | oral use |
| Ireland | 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 | tablet | oral use |
| Ireland | Meda Health Sales Ireland Limited
  Unit 34/35, Block A
  Dunboyne Business Park
  Dunboyne Co. Meath
  Ireland | Parlodel 5 mg Hard Capsules | 5 mg | capsule, hard | oral use |
| Lithuania | Gedeon Richter Plc.
  Gyömröi út 19-21
  1103 Budapest
  Hungary | BROMOCRIPTIN-RICHTER | 2.5 mg | tablet | oral use |
| Luxembourg | MEDA Pharma GmbH & Co. KG
  Benzstraße 1
  61352 Bad Homburg
  Germany | Pravidel | 2.5 mg | tablet | oral use |
| Norway | Meda AS
  Askerveien 61
  Postboks 194
  1371 Asker
  Norway | Parlodel | 2.5 mg | tablet | oral use |
| Poland | Sandoz GmbH
  Biochemiestrasse 10
  Kundl
  6250 Tyrol
  Austria | Bromergon | 2.5 mg | tablet | oral use |
| Poland | Farmaceutyczna Spółdzielnia Pracy FILOFARM
  ul. Pułaskiego 39
  85-619 Bydgoszcz
  Poland | Bromocorn | 2.5 mg | tablet | oral use |
| Poland | Meda Aktiebolag
  Pipers vag 2
  170 09 Solana
  Box 906
  Sweden | Parlodel | 2.5 mg | tablet | oral use |
| Portugal | Meda Pharma — Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Parlodel | 5 mg | capsule | oral use |
| Portugal | Meda Pharma — Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Parlodel | 10 mg | capsule | oral use |
| Portugal | Meda Pharma — Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Parlodel | 2.5 mg | tablet | oral use |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  Amadora, 2700-487
  Portugal | Bromocriptina Generis 2,5 mg comprimidos | 2.5 mg | tablet | oral use |
| Romania | S.C. BIOFARM S.A.
  Str. Logofăt Tăutu nr. 99
  sector 3, Bucureşti
  031212
  Romania | BROMOCRIPTIN | 2.5 mg | coated tablet | oral use |
| Slovak Republic | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  100 00 Praha 10
  Czech Republic | Parlodel | 2.5 mg | tablet | oral use |
| Slovak Republic | Medochemie Ltd.
  1-10 Constantinoupoleos St.
  3011 Limassol
  Cyprus | MEDOCRIPTINE 2,5 mg | 2.5 mg | tablet | oral use |
| Slovenia | Lek farmacevtska družba d.d. Verovškova 57
  1526 Ljubljana Slovenia | Bromergon 2,5 mg tablete | 2.5 mg | tablet | oral use |
| Spain | 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 | tablet | oral use |
| Sweden | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 2.5 mg | tablet | oral use |
| Sweden | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 10 mg | capsule, hard | oral use |
| Sweden | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 5 mg | capsule, hard | oral use |
| The Netherlands | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 10 mg capsules | 10 mg | capsule, hard | oral use |
| The Netherlands | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 2,5 mg | 2.5 mg | tablet | oral use |
| The Netherlands | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 5 mg capsules | 5 mg | capsule, hard | oral use |
| United Kingdom | Teva UK Limited
  Brampton Road, Hampden Park Eastbourne, East Sussex
  BN22 9AG
  United Kingdom | Teva UK Bromocriptine Tablets | 2.5 mg | tablet | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road
  Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 1 mg Tablets | 1 mg | tablet | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House, Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 2.5 mg Tablets | 2.5 mg | tablet | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House, Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 5 mg Tablets | 5 mg | capsule | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 10 mg Tablets | 10 mg | capsule | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Bromocriptine 1 mg Tablets | 1 mg | tablet | oral use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Bromocriptine 2.5 mg Tablets | 2.5 mg | tablet | oral use |

Member State

in EEA

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Meda Pharma GmbH

Guglgasse 15/II. Stock 1110

Wien

Austria

Parlodel 2,5 mg — Tabletten

2.5 mg

tablet

oral use

Belgium

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel

2.5 mg

tablet

oral use

Belgium

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel 5 mg

5 mg

capsule, hard

oral use

Belgium

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel 10 mg

10 mg

capsule, hard

oral use

Bulgaria

Sopharma AD

16 ‘Iliensko shose’ Str.

Sofia 1220

Bulgaria

Bromocriptine Sopharma

2.5 mg

tablet

oral use

Bulgaria

Medochemie Ltd.

1-10 Astronafton Str.

Limassol 3505

Cyprus

Medocriptine

2.5 mg

tablet

oral use

Croatia

Sandoz d.o.o.

Maksimirska 120/V

Zagreb 10  000

Croatia

Bromergon 2,5 mg tablete

2.5 mg

tablet

oral use

Cyprus

Codal Synto Ltd

33 Theklas Lysioti street Dorothea Building, 6th floor

Lemesos 3508

Cyprus

Pirodal

2.5 mg

tablet

oral use

Cyprus

Remedica Ltd Aharnon Street

Limassol Industrial Estate

Lemesos 3508 Cyprus

Brameston

2.5 mg

tablet

oral use

Cyprus

Medochemie Ltd Constantinoupoleos 1-10 Street

Lemesos 3501 Cyprus

Medocriptine

2.5 mg

tablet

oral use

Czech Republic

MEDA Pharma s.r.o.

Kodaňská 1441/46

110 00 Prague 10

Czech Republic

Parlodel

2.5 mg

tablet

oral use

Czech Republic

Medochemie Ltd.

Constantinoupoleos Str. 1-10

3011 Limassol — Tsiflikoudia

Cyprus

Medocriptine

2.5 mg

tablet

oral use

Denmark

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

10 mg

capsule, hard

oral use

Denmark

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

5 mg

capsule, hard

oral use

Denmark

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

2.5 mg

tablet

oral use

Estonia

Gedeon Richter Plc.

Gyömrõi ut 19-21

1103 Budapest

Hungary

BROMOCRIPTIN-RICHTER

2.5 mg

tablet

oral use

Finland

Meda Oy

Vaisalantie 4

02130 Espoo

Finland

PARLODEL

2.5 mg

tablet

oral use

France

MEDA PHARMA

25, boulevard de l'Amiral Bruix 75016 Paris

France

PARLODEL 2,5 mg inhibition de la lactation

2.5 mg

tablet

oral use

France

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 PARIS

France

BROMOCRIPTINE ZENTIVA 2,5 mg lNHIBITION DE LA LACTATION

2.5 mg

tablet

oral use

Germany

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Bromocriptin AbZ 2,5 mg

2.5 mg

tablet

oral use

Germany

Betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Bromocriptin beta 2,5

2.5 mg

tablet

oral use

Germany

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

bromocriptin-ct 2,5 mg Tabletten

2.5 mg

tablet

oral use

Germany

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Bromocriptin HEXAL 2,5 mg Tabletten

2.5 mg

tablet

oral use

Germany

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Pravidel 2,5 mg Tabletten

2.5 mg

tablet

oral use

Germany

Ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Bromocriptin-ratiopharm 2,5 mg Tabletten

2.5 mg

tablet

oral use

Greece

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

2.5 mg

tablet

oral use

Greece

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

5 mg

capsule, hard

oral use

Greece

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

10 mg

capsule, hard

oral use

Hungary

Gedeon Richter Plc

Gyömrői út 19-21

H-1103 Budapest

Hungary

Bromocriptin-Richter 2,5 mg tabletta

2.5 mg

tablet

oral use

Ireland

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

tablet

oral use

Ireland

Meda Health Sales Ireland Limited

Unit 34/35, Block A

Dunboyne Business Park

Dunboyne Co. Meath

Ireland

Parlodel 5 mg Hard Capsules

5 mg

capsule, hard

oral use

Lithuania

Gedeon Richter Plc.

Gyömröi út 19-21

1103 Budapest

Hungary

BROMOCRIPTIN-RICHTER

2.5 mg

tablet

oral use

Luxembourg

MEDA Pharma GmbH & Co. KG

Benzstraße 1

61352 Bad Homburg

Germany

Pravidel

2.5 mg

tablet

oral use

Norway

Meda AS

Askerveien 61

Postboks 194

1371 Asker

Norway

Parlodel

2.5 mg

tablet

oral use

Poland

Sandoz GmbH

Biochemiestrasse 10

Kundl

6250 Tyrol

Austria

Bromergon

2.5 mg

tablet

oral use

Poland

Farmaceutyczna Spółdzielnia Pracy FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

Bromocorn

2.5 mg

tablet

oral use

Poland

Meda Aktiebolag

Pipers vag 2

170 09 Solana

Box 906

Sweden

Parlodel

2.5 mg

tablet

oral use

Portugal

Meda Pharma — Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Parlodel

5 mg

capsule

oral use

Portugal

Meda Pharma — Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Parlodel

10 mg

capsule

oral use

Portugal

Meda Pharma — Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Parlodel

2.5 mg

tablet

oral use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora, 2700-487

Portugal

Bromocriptina Generis 2,5 mg comprimidos

2.5 mg

tablet

oral use

Romania

S.C. BIOFARM S.A.

Str. Logofăt Tăutu nr. 99

sector 3, Bucureşti

031212

Romania

BROMOCRIPTIN

2.5 mg

coated tablet

oral use

Slovak Republic

MEDA Pharma s.r.o.

Kodaňská 1441/46

100 00 Praha 10

Czech Republic

Parlodel

2.5 mg

tablet

oral use

Slovak Republic

Medochemie Ltd.

1-10 Constantinoupoleos St.

3011 Limassol

Cyprus

MEDOCRIPTINE 2,5 mg

2.5 mg

tablet

oral use

Slovenia

Lek farmacevtska družba d.d. Verovškova 57

1526 Ljubljana Slovenia

Bromergon 2,5 mg tablete

2.5 mg

tablet

oral use

Spain

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

tablet

oral use

Sweden

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

2.5 mg

tablet

oral use

Sweden

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

10 mg

capsule, hard

oral use

Sweden

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

5 mg

capsule, hard

oral use

The Netherlands

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 10 mg capsules

10 mg

capsule, hard

oral use

The Netherlands

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 2,5 mg

2.5 mg

tablet

oral use

The Netherlands

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 5 mg capsules

5 mg

capsule, hard

oral use

United Kingdom

Teva UK Limited

Brampton Road, Hampden Park Eastbourne, East Sussex

BN22 9AG

United Kingdom

Teva UK Bromocriptine Tablets

2.5 mg

tablet

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House Parsonage Road

Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 1 mg Tablets

1 mg

tablet

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House, Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 2.5 mg Tablets

2.5 mg

tablet

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House, Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 5 mg Tablets

5 mg

capsule

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 10 mg Tablets

10 mg

capsule

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Bromocriptine 1 mg Tablets

1 mg

tablet

oral use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Bromocriptine 2.5 mg Tablets

2.5 mg

tablet

oral use

---