EN Official Journal of the European Union C 186/2

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))

(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

— 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

— 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

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

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