EN Official Journal of the European Union C 266/5

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 September 2004 to 15 October 2004

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

(2004/C 266/04)

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 20.9.2004 Angiox The Medicines Company UK Ltd, Suite B, Park House, 11 Milton Park, Abingdon, Oxfordshire OX14 4RS, United Kingdom EU/1/04/289/001 22.9.2004 20.9.2004 Alimta Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/290/001 22.9.2004 20.9.2004 Raptiva Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/04/291/001-002 22.9.2004 21. 9.2004 Protelos Les Laboratoires Servier, 22, rue Garnier, F-92200 Neuilly-sur-Seine EU/1/04/288/001-006 23.9.2004 21. 9.2004 Osseor Les Laboratoires Servier, 22, rue Garnier, F-92200 Neuilly-sur-Seine EU/1/04/287/001-006 23.9.2004 27. 9.2004 Apidra Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, EU/1/04/285/001-020 29. 9.2004 13.10.2004 Wilzin Orphan Europe SARL, Immeuble ‘Le Guillaumet’ F-92046 Paris-La-Défense EU/1/04/286/001-002 18.10.2004

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 20.9.2004 Remicade Centocor BV, Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-003 22.9.2004 20.9.2004 Azomyr Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels EU/1/00/157/014-021 22.9.2004 20.9.2004 Aerius Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels EU/1/00/160/014-021 22.9.2004 20.9.2004 Neoclarityn Schering Plough Europe, Rue de Stalle, 73, B-1180 Brussels, EU/1/00/161/014-021 22.9.2004 20.9.2004 Lantus Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main, EU/1/00/134/008-011 EU/1/00/134/018-021 22.9.2004 20.9.2004 Velcade Millennium Pharmaceuticals, Ltd, Building 3, Chiswick Park, 566 Chiswick High Road, Chiswick, London, W4 5YA United Kingdom EU/1/04/274/001 22.9.2004 20.9.2004 Velcade Janssen-Cilag International NV, Turnhoutsewe 30, B–2340 Beerse EU/1/04/274/001 23.9.2004 20.9.2004 Ovitrelle Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/165/001-007 22.9.2004 21.9.2004 Carbaglu Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris-La-Défense EU/1/02/246/001-002 23.9.2004 21.9.2004 KOGENATE Bayer Bayer AG, D-51368 Leverkusen, Deutschland EU/1/00/143/004-006 23.9.2004 23.9.2004 Remicade Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-003 27.9.2004 24.9.2004 Insuman Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, EU/1/97/030/065-084 29.9.2004 24.9.2004 InductOs Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/02/226/001 28.9.2004 24.9.2004 Enbrel Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-003 28.9.2004 27.9.2004 SonoVue Bracco International BV, Strawinskylaan 3051, 1077ZX Amsterdam, Nederland EU/1/01/177/001-002 29.9.2004 27.9.2004 Ceprotin Baxter AG, Industriesstrasse 67, 1220 Vienna, Österreich EU/1/01/190/001-002 29.9.2004 27.9.2004 Avonex Biogen Idec France, ‘Le Capitole’ 55, avenue des Champs Pierreux, F-92012 Nanterre Cedex EU/1/97/033/001-003 30. 9.2004 13.10.2004 Revasc Canyon Pharmaceuticals Ltd, 20-22 Bedford Row - WC1R 4JS London - United Kingdom EU/1/97/043/001-002 19.10.2004 Aventis Pharma SA, 20 Avenue Raymond Aron, Antony Cedex F-92165 18.10.2004 13.10.2004 Arava Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/99/118/001-010 18.10.2004 13.10.2004 Vaniqa Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/01/173/001-003 18.10.2004 13.10.2004 NovoRapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/99/119/001-014 18.10.2004 13.10.2004 Levviax Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony EU/1/01/192/001-005 19.10.2004 15.10.2004 Ketek Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony EU/1/01/191/001-005 19.10.2004 15.10.2004 Viramune Boehringer Ingelheim International GmbH, Binger Strasse, 173 D-55216 Ingelheim am Rhein, Deutschland EU/1/97/055/001-002 19.10.2004 15.10.2004 Fuzeon Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY EU/1/03/252/001-003 20.10.2004 15.10.2004 NovoRapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-014 19.10.2004

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 28.9.2004 Ixense Takeda Europe R&D Centre Ltd, Savanah House, 11/12 Charles II Street, London SW1Y 4QU, United Kingdom EU/1/01/181/001-007 30.9.2004

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