EN Official Journal of the European Union C 130/5

Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 April 2005 to 15 May 2005

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

(2005/C 130/04)

— 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 20.4.2005 Velcade Janssen-Cilag International NV, Turnhoutseweg, 30 — B-2340 Beerse EU/1/04/274/001 22.4.2005 20.4.2005 Viramune Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein EU/1/97/055/001-002 22.4.2005 20.4.2005 Paxene Norton Healthcare Limited, Albert Basin, Royal Docks, London E16 2QJ, United Kingdom EU/1/99/113/001-004 22.4.2005 25.4.2005 Zeffix Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/99/114/001-003 27.4.2005 25.4.2005 HBVAXPRO Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, F-69007 Lyon EU/1/01/183/001-019 27.4.2005 25.4.2005 Humira Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/256/001-006 27.4.2005 25.4.2005 GONAL f Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/95/001/001-035 27.4.2005 25.4.2005 Trudexa Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/257/001-006 27.4.2005 27.4.2005 Viagra Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/98/077/001-012 29.4.2005 27.4.2005 Keppra UCB SA, Allée de la recherche, 60, B-1070 Bruxelles Researchdreef, 60, B-1070 Brussel EU/1/00/146/001-027 29.4.2005 27.4.2005 Lantus Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/00/134/012 29.4.2005 27.4.2005 Optisulin Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/00/133/008 29.4.2005 27.4.2005 Forsteo Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/03/247/001-002 29.4.2005 27.4.2005 Neupopeg Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano EU/1/02/228/001-002 29.4.2005 27.4.2005 Cellcept Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/96/005/001-006 29.4.2005 27.4.2005 Carbaglu Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense EU/1/02/246/001-003 29.4.2005 28.4.2005 Herceptin Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/00/145/001 3.5.2005 28.4.2005 Emend Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262/001-006 3.5.2005 28.4.2005 Emend Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262/001-006 3.5.2005 28.4.2005 Enbrel Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/006-011 3.5.2005 28.4.2005 Rapamune Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/01/171/001-012 3.5.2005 29.4.2005 Neulasta Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland EU/1/02/227/001-002 3.5.2005 10.5.2005 Lyrica Pfizer Ltd; Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/04/279/001-025 13.5.2005 10.5.2005 Cancidas Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/01/196/001-003 13.5.2005 13.5.2005 Apidra Aventis Pharma Deutschland GmbH, Brueningstraße 50, D-65926 Frankfurt am Main EU/1/04/285/001-028 18.5.2005

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

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 25.4.2005 Infanrix Hep B GlaxoSmithKline Biologicals SA, rue de l'Institut 89, B-1330 Rixensart EU/1/97/048/001-014 27.4.2005

— Modification of a marketing authorisation (Article 34 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 18.4.2005 Bayovac CSF E2 Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom Bayer AG, Geschäftsbereich Tiergesundheit, D-51368 Leverkusen EU/2/00/025/001-004 20.4.2005 21.4.2005 Eurifel FeLV Merial, 29 Avenue Tony Garnier, F-69007 Lyon EU/2/00/019/001-003 27.4.2005 27.4.2005 Ibraxion Merial, 29 avenue Tony Garnier, F-69007 Lyon EU/2/99/017/001-006 29.4.2005 27.4.2005 Metacam Boehringer Ingelheim Vetmedica GmbH, D-55216 Ingelheim am Rhein EU/2/97/004/001 EU/2/97/004/003-010 29.4.2005

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.