EN Official Journal of the European Union C 172/4

Summary of Community decisions on marketing authorization in respect of medicinal products from 15/04/2004 to 15/05/2004

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

(2004/C 172/03)

Issuing 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 26.04.2004 Velcade Millenium Pharmaceuticals Ltd Building 3 Chiswick Park 566 Chiswick High Road Chiswick London W4 5YA United Kingdom EU/1/04/274/001 28.04.2004 28.04.2004 Lysodren Laboratoire HRA Pharma 19, rue Frédérick Lemaitre F-75020 Paris EU/1/04/273/001 30.04.2004 28.04.2004 Dukoral SBL Vaccin AB S-105 21 Stockholm EU/1/03/263/001-003 03.05.2004

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 22.04.2004 Onsenal Pharmacia-Pfizer EEIG Hillbottom Road High Wycombe Bucks HP12 4PX United Kingdom EU/1/03/259/001-006 04.05.2004 22.04.2004 Kudeq Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom EU/1/02/244/001-024 27.04.2004 22.04.2004 Bextra Pharmacia-Pfizer EEIG Hillbottom Road High Wycombe Bucks HP12 4PX United Kingdom EU/1/02/239/001-024 04.05.2004 22.04.2004 Dynastat Pharmacia Europe EEIG Hillbottom Road High Wycombe Buckinghamshire HP12 4PX United Kingdom EU/1/02/209/001-008 04.05.2004 22.04.2004 Rayzon Pharmacia Europe EEIG Hillbottom Road High Wycombe Buckinghamshire HP12 4PX United Kingdom EU/1/02/210/001-008 04.05.2004 28.04.2004 Zerit Bristol-Myers Squibb Pharma EEIG 141-149 Staines Road Hounslow TW3 3JA United Kingdom EU/1/96/009/001-017 30.04.2004 28.04.2004 Viracept Roche Registration Limited 40 Broadwater Road Welwyn Garden City Hertfordshire AL7 3AY United Kingdom EU/1/97/054/006 30.04.2004 29.04.2004 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/99/111/001-009 07.05.2004 29.04.2004 Sustiva Bristol-Myers Squibb Pharma EEIG 141-149 Staines Road Hounslow TW3 3JA United Kingdom EU/1/99/110/001-009 04.05.2004 07.05.2004 Ferriprox Apotex Europe Ltd Rowan House 41 London Street Reading Berkshire RG1 4PS United Kingdom EU/1/99/108/001 11.05.2004 10.05.2004 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/001-003 12.05.2004 11.05.2004 Cancidas Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/01/196/001-003 13.05.2004 13.05.2004 Cancidas Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/01/196/001-003 17.05.2004

Issuing 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 07.05.2004 Equilis StrepE Intervet International BV Wim de Körverstraat, 35 5831 AN Boxmeer Nederland EU/2/04/043/001 11.05.2004

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 28.04.2004 SevoFlo Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/2/02/035/001-006 30.04.2004 28.04.2004 Locatim Biokema Anstalt Aeulestrasse 38 9490 Vaduz Fürstentum Liechtenstein EU/2/99/011/001 29.04.2004

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 Agency for the Evaluation of Medicinal products 7, Westferry Circus, Canary Wharf LONDON E14 4HB United Kingdom

(1) OJ L 214 du 24 August 1993, page 1.