EN Official Journal of the European Union C 217/5

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.7.2006 to 31.7.2006

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2006/C 217/03)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 19.7.2006 SUTENT sunitinib Pfizer Ltd. Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/347/001-003 Capsule, hard L01XE04 24.7.2006 19.7.2006 Nexavar Sorafenib Bayer HealthCare AG D-51368 Leverkusen EU/1/06/342/001 Film-coated tablet L01XE05 21.7.2006 28.7.2006 ATryn antithrombin alfa Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/06/355/001-003 Powder for solution for infusion B01AB02 2.8.2006 28.7.2006 Livensa testosterone Procter & Gamble Pharmaceuticals — Germany GmbH Dr. Otto-Röhm-Strasse 2-4 D-64331 Weiterstadt EU/1/06/351/001-003 Transdermal patch G03BA03 1.8.2006 28.7.2006 Savene Dexrazoxane TopoTarget A/S Fruebjergvej 3 DK-Denmark EU/1/06/350/001 Powder for concentrate and diluent for solution for infusion V03AF02 2.8.2006 28.7.2006 Intrinsa testosterone Procter & Gamble Pharmaceuticals UK Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW United Kingdom EU/1/06/352/001-003 Transdermal patch G03BA03 3.8.2006 28.7.2006 Competact Pioglitazone/metformin Takeda Global Research and Development Centre (Europe) Ltd. Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/06/354/001-009 Film-coated tablet (Non applicable) 1.8.2006

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 4.7.2006 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 6.7.2006 4.7.2006 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/04/300/001-002 6.7.2006 4.7.2006 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron F-92165 Antony Cedex EU/1/95/002/001-002 6.7.2006 4.7.2006 Zeffix Glaxo Group Ltd. Greenford Middlesex UB6 0NN United Kingdom EU/1/99/114/001-003 6.7.2006 4.7.2006 Dynastat Pfizer Ltd. Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/02/209/001-008 6.7.2006 4.7.2006 Lyrica Pfizer Ltd. Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/04/279/001-035 6.7.2006 6.7.2006 Mabthera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/98/067/001-002 10.7.2006 6.7.2006 REYATAZ Bristol-Myers Squibb Pharma EEIG 141-149 Staines Road Hounslow TW3 3JA United Kingdom EU/1/03/267/001-007 10.7.2006 6.7.2006 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/99/118/001-010 10.7.2006 6.7.2006 Levemir Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/04/278/001-009 10.7.2006 11.7.2006 Comtess Orion Corporation Orionintie 1 FIN-02200 Espoo EU/1/98/082/001-005 13.7.2006 11.7.2006 Fareston Orion Corporation Orionintie 1 FIN-02200 Espoo EU/1/96/004/001-002 13.7.2006 11.7.2006 Stalevo Orion Corporation Orionintie 1 FIN-02200 Espoo EU/1/03/260/001-015 13.7.2006 11.7.2006 Trisenox Cephalon UK Ltd. 20 Alan Turing Road Surrey Research Park Guildford Surrey GU2 7YF United Kingdom EU/1/02/204/001 13.7.2006 12.7.2006 AVANDIA SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/00/137/002-018 14.7.2006 13.7.2006 Starlix Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/174/001-021 17.7.2006 13.7.2006 Trazec Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/175/001-021 17.7.2006 13.7.2006 Mimpara Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/04/292/001-012 17.7.2006 13.7.2006 Parareg Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/04/293/001-012 17.7.2006 14.7.2006 Revasc Canyon Pharmaceuticals Ltd. 20-22 Bedford Row WC1R 4JS London United Kingdom EU/1/97/043/001-003 20.7.2006 19.7.2006 PegIntron Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles EU/1/00/131/001-050 25.7.2006 19.7.2006 Viraferon Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles EU/1/99/128/001-037 25.7.2006 19.7.2006 IntronA Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles EU/1/99/127/001-044 25.7.2006 19.7.2006 ViraferonPeg Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles EU/1/00/132/001-050 25.7.2006 20.7.2006 Avandamet SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/03/258/001-022 26.7.2006 20.7.2006 GONAL-f Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom EU/1/95/001/001 EU/1/95/001/003-005 EU/1/95/001/009 EU/1/95/001/012 EU/1/95/001/021-022 EU/1/95/001/025-028 EU/1/95/001/031-035 26.7.2006 20.7.2006 Actos Takeda Global Research and Development Centre (Europe) Ltd. Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/00/150/001-024 26.7.2006 20.7.2006 Glustin Takeda Global Research and Development Centre (Europe) Ltd. Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/00/151/001-022 26.7.2006 20.7.2006 Tractocile Ferring AB Soldattorpsvägen 5 Box 30 047 S-20061 Limhamn EU/1/99/124/001-002 27.7.2006 20.7.2006 NovoRapid Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-014 26.7.2006 20.7.2006 Pegasys Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/221/001-010 26.7.2006 20.7.2006 Fuzeon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/252/001-003 26.7.2006 25.7.2006 Keppra UCB S.A. Allée de la recherche, 60 B-1070 Bruxelles EU/1/00/146/001-030 28.7.2006 25.7.2006 Synagis Abbott laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom EU/1/99/117/001-002 28.7.2006 25.7.2006 Rebetol Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles EU/1/99/107/001-005 28.7.2006 25.7.2006 Nonafact Sanquin Plesmanlaan 125 1066 CX Amsterdam Nederland EU/1/01/186/001-002 28.7.2006 25.7.2006 CUBICIN Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom Chiron Corporation Ltd. Symphony House 7 Cowley Business Park High Street Cowley Uxbridge UB8 2AD United Kingdom EU/1/05/328/001-002 28.7.2006 28.7.2006 Replagal TKT Europe AB Rinkebyvägen 11B S-182 36 Danderyd EU/1/01/189/001-006 1.8.2006 28.7.2006 Myocet Zeneus Pharma Limited The Magdalen Centre Oxford Science Park Oxford OX4 4GA United Kingdom Elan Pharma International Ltd. WIL House Shannon Business Park Shannon County Clare Ireland EU/1/00/141/001 1.8.2006 28.7.2006 INOmax INO Therapeutics AB S-181 81 Lidingö EU/1/01/194/001-002 2.8.2006 28.7.2006 Rilutek Aventis Pharma S.A. 20, Avenue Raymond Aron F-92165 Antony Cedex EU/1/96/010/001 2.8.2006 28.7.2006 Epivir Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/96/015/001-005 2.8.2006 28.7.2006 Fabrazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/01/188/001-006 2.8.2006 28.7.2006 DaTSCAN GE Healthcare Limited Little Chalfont Bucks HP7 9NA United Kingdom EU/1/00/135/001-002 2.8.2006 28.7.2006 Velcade Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/04/274/001 2.8.2006 28.7.2006 REYATAZ Bristol-Myers Squibb Pharma EEIG 141-149 Staines Road Hounslow TW3 3JA United Kingdom EU/1/03/267/001-007 2.8.2006 28.7.2006 Kineret Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/02/203/001-004 2.8.2006 28.7.2006 Procomvax Sanofi Pasteur MSD S.N.C. 8, rue Jonas Salk F-69007 Lyon EU/1/99/104/001 2.8.2006 28.7.2006 MabCampath Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/01/193/001-002 3.8.2006 28.7.2006 Tritanrix HepB GlaxoSmithKline Biologicals s.a. rue de l'Institut, 89 B-1330 Rixensart EU/1/96/014/001-003 3.8.2006 28.7.2006 Ceprotin Baxter AG Industriesstrasse 67 A-1220 Vienna EU/1/01/190/001-002 2.8.2006 28.7.2006 Myozyme Genzyme Europe B.V. Gooimeer 10 NL-1411 DD Naarden Nederland EU/1/06/333/001-003 2.8.2006 28.7.2006 Prialt Elan Pharma International Ltd. WIL House Shannon Business Park Shannon County Clare Ireland EU/1/04/302/001-004 2.8.2006 28.7.2006 Rapamune Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/01/171/001 EU/1/01/171/007-012 2.8.2006 28.7.2006 Bonviva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom EU/1/03/265/001-006 2.8.2006 28.7.2006 Bondenza Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom EU/1/03/266/001-006 2.8.2006 28.7.2006 Cialis Lilly ICOS Limited St Bride's House 10 Salisbury Square London EC4Y 8EH United Kingdom EU/1/02/237/001-005 2.8.2006 28.7.2006 Norvir Abbott laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom EU/1/96/016/001 EU/1/96/016/003 2.8.2006 28.7.2006 Vivanza Bayer AG D-51368 Leverkusen EU/1/03/249/001-012 2.8.2006 28.7.2006 Levitra Bayer AG D-51368 Leverkusen EU/1/03/248/001-013 2.8.2006

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 11.7.2006 Dexdomitor Orion Corporation Orionintie 1 FIN-02200 Espoo EU/2/02/033/001 13.7.2006 14.7.2006 Vaxxitek HVT+ IBD Merial 29, avenue Tony Garnier F-69007 Lyon EU/2/02/032/001 18.7.2006 20.7.2006 Porcilis Porcoli Intervet International B.V. (NL) Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/96/001/003-010 26.7.2006 20.7.2006 Rabigen SAG2 VIRBAC S.A. 1ère Avenue 2065 m L.I.D. F-06516 Carros EU/2/00/021/001-002 26.7.2006

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 136, 30 April 2004, p. 1.