# C_2005186EN.01000201.xml

| 29.7.2005 | EN | Official Journal of the European Union | C 186/2 |
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29.7.2005

EN

Official Journal of the European Union

C 186/2

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 June 2005 to 30 June 2005

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

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

(2005/C 186/02)

—   Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 16.6.2005 | Tracleer | Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220/001-005 | 20.6.2005 |
| 20.6.2005 | Abilify | Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW, United Kingdom | EU/1/04/276/021-032 | 22.6.2005 |
| 24.6.2005 | Vistide | Pfizer Enterprises SARL, 51, Avenue Kennedy — Rond Point du Kirchberg, L-1855 Luxembourg, Grand-Duché de Luxembourg. | EU/1/97/037/001 | 28.6.2005 |
| 28.6.2005 | Taxotere | Aventis Pharma S.A., 20 avenue Raymond Aron, 92165 Antony Cedex, France | EU/1/95/002/001-002 | 30.6.2005 |
| 28.6.2005 | Invirase | Roche Registration Ltd., 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom | EU/1/96/026/001-002 | 30.6.2005 |
| 28.6.2005 | Osigraft | Howmedica International S. de R.L., Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland | EU/1/01/179/001 | 4.7.2005 |
| 28.6.2005 | Herceptin | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/00/145/001 | 30.6.2005 |
| 28.6.2005 | Remicade | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-003 | 30.6.2005 |
| 28.6.2005 | Remicade | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-003 | 30.6.2005 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

16.6.2005

Tracleer

Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/220/001-005

20.6.2005

20.6.2005

Abilify

Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW, United Kingdom

EU/1/04/276/021-032

22.6.2005

24.6.2005

Vistide

Pfizer Enterprises SARL, 51, Avenue Kennedy — Rond Point du Kirchberg, L-1855 Luxembourg, Grand-Duché de Luxembourg.

EU/1/97/037/001

28.6.2005

28.6.2005

Taxotere

Aventis Pharma S.A., 20 avenue Raymond Aron, 92165 Antony Cedex, France

EU/1/95/002/001-002

30.6.2005

28.6.2005

Invirase

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

EU/1/96/026/001-002

30.6.2005

28.6.2005

Osigraft

Howmedica International S. de R.L., Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland

EU/1/01/179/001

4.7.2005

28.6.2005

Herceptin

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

EU/1/00/145/001

30.6.2005

28.6.2005

Remicade

Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-003

30.6.2005

28.6.2005

Remicade

Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-003

30.6.2005

—   Withdrawal of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 24.6.2005 | Valdyn | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/244/001-024 | 28.6.2005 |
| 24.6.2005 | Rayzon | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/210/001-008 | 29.6.2005 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

24.6.2005

Valdyn

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

EU/1/02/244/001-024

28.6.2005

24.6.2005

Rayzon

Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/210/001-008

29.6.2005

—   Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 16.6.2005 | Aivlosin | ECO Animal Health Ltd, 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | EU/2/04/044/001 | 20.6.2005 |
| 21.6.2005 | Dexdomitor | Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi | EU/2/02/033/001 | 23.6.2005 |
| 24.6.2005 | Dexdomitor | Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi | EU/2/02/033/001 | 28.6.2005 |
| 24.6.2005 | DRAXXIN | PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/2/03/041/001-005 | 28.6.2005 |
| 24.6.2005 | Metacam | Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim am Rhein, Deutschland | EU/2/97/004/001-011 | 28.6.2005 |
| 24.6.2005 | Porcilis Pesti | Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/99/016/001-006 | 28.6.2005 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

16.6.2005

Aivlosin

ECO Animal Health Ltd, 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom

EU/2/04/044/001

20.6.2005

21.6.2005

Dexdomitor

Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi

EU/2/02/033/001

23.6.2005

24.6.2005

Dexdomitor

Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi

EU/2/02/033/001

28.6.2005

24.6.2005

DRAXXIN

PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/03/041/001-005

28.6.2005

24.6.2005

Metacam

Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim am Rhein, Deutschland

EU/2/97/004/001-011

28.6.2005

24.6.2005

Porcilis Pesti

Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/99/016/001-006

28.6.2005

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 |
| --- |
| 7, Westferry Circus, Canary Wharf |
| London E14 4HB |
| United Kingdom |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

London E14 4HB

United Kingdom

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

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