# C_2004289EN.01000701.xml

| 26.11.2004 | EN | Official Journal of the European Union | C 289/7 |
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26.11.2004

EN

Official Journal of the European Union

C 289/7

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Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 October 2004 to 15 November 2004

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93) (1)

1

(2004/C 289/07)

Issuing of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93) — 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 |
| --- | --- | --- | --- | --- |
| 22.10.2004 | EMSELEX | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/04/294/001-012 | 26.10.2004 |
| 22.10.2004 | Mimpara | Amgen Europe BV, Minervum 7061, 4817 ZK Breda, The Netherlands | EU/1/04/292/001-012 | 26.10.2004 |
| 22.10.2004 | Parareg | Amgen Europe BV, Minervum 7061, 4817 ZK Breda, The Netherlands | EU/1/04/293/001-012 | 26.10.2004 |

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

22.10.2004

EMSELEX

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/04/294/001-012

26.10.2004

22.10.2004

Mimpara

Amgen Europe BV, Minervum 7061, 4817 ZK Breda, The Netherlands

EU/1/04/292/001-012

26.10.2004

22.10.2004

Parareg

Amgen Europe BV, Minervum 7061, 4817 ZK Breda, The Netherlands

EU/1/04/293/001-012

26.10.2004

Modification of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93) — 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 |
| --- | --- | --- | --- | --- |
| 20.10.2004 | Zeffix | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/99/114/001-003 | 22.10.2004 |
| 20.10.2004 | Puregon | Organon NV, PO box 20, 5340 BH Oss, The Netherlands | EU/1/96/008/038-039 | 22.10.2004 |
| 20.10.2004 | Viracept | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/97/054/001
  EU/1/97/054/003-006 | 22.10.2004 |
| 20.10.2004 | Taxotere | Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex, | EU/1/95/002/001-002 | 22.10.2004 |
| 20.10.2004 | ViraferonPeg | Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels | EU/1/00/132/001-050 | 22.10.2004 |
| 20.10.2004 | PegIntron | Schering Plough Europe, Rue de Stalle, 73, B-1180 BrusselsStallestraat, 73, B-1180 Brussel | EU/1/00/131/001-050 | 22.10.2004 |
| 22.10.2004 | Herceptin | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/00/145/001 | 26.10.2004 |
| 22.10.2004 | EMEND | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/03/262/001-006 | 26.10.2004 |
| 22.10.2004 | Sifrol | Boehringer Ingelheim International GmbH, Binger Strasse 173 D-55216 Ingelheim am Rhein | EU/1/97/050/001-006
  EU/1/97/050/009-012 | 26.10.2004 |
| 22.10.2004 | Bondronat | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/96/012/001-013 | 26.10.2004 |
| 28.10.2004 | Agenerase | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/00/148/001-004 | 1.11.2004 |
| 28.10.2004 | Paxene | Norton Healthcare Limited, Albert Basin, Royal Docks, London E16 2QJ, United Kingdom | EU/1/99/113/001-004 | 1.11.2004 |
| 28.10.2004 | Cancidas | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/01/196/001-003 | 1.11.2004 |
| 28.10.2004 | Ziagen | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/99/112/001-002 | 1.11.2004 |
| 28.10.2004 | Ziagen | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/99/112/001-002 | 1.11.2004 |
| 28.10.2004 | Ytracis | CIS bio international, Boite postale 32, F-91192 Gif-sur-Yvette | EU/1/03/250/001 | 3.11.2004 |
| 28.10.2004 | Mirapexin | Boehringer Ingelheim International GmbH, Binder Strasse 173, D-55216 Ingelheim am Rhein | EU/1/97/051/001-006
  EU/1/97/051/009-012 | 1.11.2004 |
| 28.10.2004 | Viraferon | Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels |
| Stallestraat, 73, B-1180 Brussel |

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

20.10.2004

Zeffix

Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/99/114/001-003

22.10.2004

20.10.2004

Puregon

Organon NV, PO box 20, 5340 BH Oss, The Netherlands

EU/1/96/008/038-039

22.10.2004

20.10.2004

Viracept

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/97/054/001

EU/1/97/054/003-006

22.10.2004

20.10.2004

Taxotere

Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex,

EU/1/95/002/001-002

22.10.2004

20.10.2004

ViraferonPeg

Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels

EU/1/00/132/001-050

22.10.2004

20.10.2004

PegIntron

Schering Plough Europe, Rue de Stalle, 73, B-1180 BrusselsStallestraat, 73, B-1180 Brussel

EU/1/00/131/001-050

22.10.2004

22.10.2004

Herceptin

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/00/145/001

26.10.2004

22.10.2004

EMEND

Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/03/262/001-006

26.10.2004

22.10.2004

Sifrol

Boehringer Ingelheim International GmbH, Binger Strasse 173 D-55216 Ingelheim am Rhein

EU/1/97/050/001-006

EU/1/97/050/009-012

26.10.2004

22.10.2004

Bondronat

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/96/012/001-013

26.10.2004

28.10.2004

Agenerase

Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/00/148/001-004

1.11.2004

28.10.2004

Paxene

Norton Healthcare Limited, Albert Basin, Royal Docks, London E16 2QJ, United Kingdom

EU/1/99/113/001-004

1.11.2004

28.10.2004

Cancidas

Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/01/196/001-003

1.11.2004

28.10.2004

Ziagen

Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/99/112/001-002

1.11.2004

28.10.2004

Ziagen

Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/99/112/001-002

1.11.2004

28.10.2004

Ytracis

CIS bio international, Boite postale 32, F-91192 Gif-sur-Yvette

EU/1/03/250/001

3.11.2004

28.10.2004

Mirapexin

Boehringer Ingelheim International GmbH, Binder Strasse 173, D-55216 Ingelheim am Rhein

EU/1/97/051/001-006

EU/1/97/051/009-012

1.11.2004

28.10.2004

Viraferon

Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels

Stallestraat, 73, B-1180 Brussel

EU/1/99/128/001-008

1.11.2004

28.10.2004

CoAprovel

Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, F-75013 Paris

EU/1/98/086/001-020

2.11.2004

28.10.2004

Karvezide

Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom

EU/1/98/085/001-020

1.11.2004

28.10.2004

Viread

Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom

EU/1/01/200/001

1.11.2004

28.10.2004

Ammonaps

Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense

EU/1/99/120/001-004

2.11.2004

28.10.2004

IntronA

| Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels |
| --- |
| Stallestraat, 73, B-1180 Brussel |

Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels

Stallestraat, 73, B-1180 Brussel

EU/1/99/127/001-010

EU/1/99/127/040

2.11.2004

29.10.2004

PEGASYS

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/02/221/001-010

5.11.2004

29.10.2004

MabCampath

ILEX Pharmaceutical Ltd, 1 & 3 Frederick Sanger Road, The Surrey Research Park, Guildford, Surrey GU2 7YD, United Kingdom

EU/1/01/193/002

5.11.2004

29.10.2004

Liprolog

Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands

EU/1/01/195/001-015

5.11.2004

4.11.2004

Zometa

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/176/001-006

8.11.2004

4.11.2004

Zyprexa

Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands

EU/1/96/022/002, EU/1/96/022/004, EU/1/96/022/006, EU/1/96/022/008-012, EU/1/96/022/014, EU/1/96/022/016-022

8.11.2004

4.11.2004

Zyprexa Velotab

Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands

EU/1/99/125/001-008

8.11.2004

4.11.2004

Zyprexa Velotab

Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands

EU/1/99/125/001-008

8.11.2004

9.11.2004

Vfend

Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/02/212/001-026

15.11.2004

12.11.2004

Arixtra

Sanofi-Synthelabo 174 avenue de France, F-75013 Paris

EU/1/02/206/009-017

16.11.2004

12.11.2004

Quixidar

N.V. Organon PO box 20, Kloosterstraat 6, 5340 EB Oss, The Netherlands

EU/1/02/207/009-017

16.11.2004

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(1)  OJ L 214, 24.8.1993, p. 1.

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