EN Official Journal of the European Union C 209/3

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2005 to 31 July 2005

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

(2005/C 209/03)

— 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 4.7.2005 Apidra Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main EU/1/04/285/001-028 6.7.2005 4.7.2005 Forcaltonin Unigene UK Limited, 63 High Road, Bushey Heath, Herts, WD2 1EE, United Kingdom EU/1/98/093/002 6.7.2005 4.7.2005 Trisenox Cell Therapeutics (UK) Ltd, 100 Pall Mall, London SW1Y 5HP, United Kingdom EU/1/02/204/001 6.7.2005 4.7.2005 Levemir Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd EU/1/04/278/001-009 6.7.2005 4.7.2005 Zerene Wyeth Research (UK) Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/099/001-006 6.7.2005 4.7.2005 Sonata Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/102/001-008 6.7.2005 4.7.2005 Cymbalta Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/296/001-006 6.7.2005 4.7.2005 Cymbalta Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/296/001-006 6.7.2005 4.7.2005 Xeristar Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein EU/1/04/297/001-006 6.7.2005 4.7.2005 Xeristar Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein EU/1/04/297/001-006 6.7.2005 4.7.2005 Visudyne Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/00/140/001 6.7.2005 4.7.2005 Xigris Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/02/225/001-002 6.7.2005 7.7.2005 Invanz Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/02/216/001-002 11.7.2005 7.7.2005 Arixtra Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/206/001-008 11.7.2005 7.7.2005 Quixidar Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/207/001-008 11.7.2005 7.7.2005 Cystagon Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense EU/1/97/039/001-004 11.7.2005 8.7.2005 Glivec Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 12.7.2005 8.7.2005 Aranesp Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland EU/1/01/185/001-056 12.7.2005 8.7.2005 Nespo Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano EU/1/01/184/001-056 12.7.2005 8.7.2005 Lyrica PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/04/279/030-032 12.7.2005 8.7.2005 Fortovase Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/98/075/001-002 12.7.2005 8.7.2005 AVANDIA SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/00/137/001-012 12.7.2005 8.7.2005 NovoRapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd EU/1/99/119/003 EU/1/99/119/005-007 EU/1/99/119/009-014 12.7.2005 8.7.2005 NeuroBloc Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland EU/1/00/166/001-003 13.7.2005 8.7.2005 Simulect Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/084/001-002 12.7.2005 8.7.2005 Zevalin Schering AG, Müllerstrasse 170-178, D-13342 Berlin EU/1/03/264/001 12.7.2005 8.7.2005 Viread Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom EU/1/01/200/001 12.7.2005 8.7.2005 Keppra UCB SA, Allée de la recherche, 60, B-1070 Bruxelles/Researchdreef, 60, B-1070 Brussel EU/1/00/146/001-027 12.7.2005 8.7.2005 Lantus Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/00/134/001-029 12.7.2005 8.7.2005 Optisulin Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/00/133/001-008 12.7.2005 13.7.2005 NeoRecormon Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/97/031/001-003 EU/1/97/031/019-046 15.7.2005 22.7.2005 Enbrel Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-011 26.7.2005 22.7.2005 KOGENATE Bayer Bayer AG, D-51368 Leverkusen EU/1/00/143/001-006 26.7.2005 27.7.2005 Vaniqa Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/01/173/001-003 29.7.2005 27.7.2005 Infergen Yamanouchi Europe B.V., Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/98/087/001-003 29.7.2005 27.7.2005 Zevalin Schering AG, Müllerstrasse 170-178, D-13342 Berlin EU/1/03/264/001 29.7.2005 27.7.2005 Replagal TKT Europe AB, Rinkebyvägen 11B, S-182 36 Danderyd EU/1/01/189/001-006 29.7.2005 27.7.2005 Velcade Janssen-Cilag International NV, Turnhoutseweg, 30 B-2340 Beerse EU/1/04/274/001 29.7.2005 27.7.2005 AVANDIA SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/00/137/001-012 29.7.2005 27.7.2005 ReFacto Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/103/001-004 29.7.2005 28.7.2005 Kineret Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland EU/1/02/203/001-004 1.8.2005

— 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 8.7.2005 Equilis Prequenza Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/056/001-002 12.7.2005 8.7.2005 Equilis Prequenza Te Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/057/001-002 12.7.2005 8.7.2005 Equilis Te Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/055/001-002 12.7.2005 27.7.2005 Profender Bayer Healthcare AG, D-51368 Leverkusen EU/2/05/054/001-017 29.7.2005

— 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 7.7.2005 Neocolipor Merial, 29 avenue Tony Garnier, F-69007 Lyon EU/2/98/008/001-004 11.7.2005 8.7.2005 Ibaflin Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/022/001a-001b, 002a-002b, 003a-003b, 004a-004b, EU/2/00/022/005-017, 12.7.2005

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.