EN Official Journal of the European Union C 46/21

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2006 to 31 January 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 46/03)

— 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 19.1.2006 Kiovig Human normal immunoglobulin (IVIg) Baxter AG, Industriestraße 67, A-1220 Vienna EU/1/05/329/001-005 Solution for infusion J06BA02 23.1.2006 19.1.2006 Yttriga Yttrium (90Y) Chloride AEA Technology QSA GmbH, Gieselweg 1, D-38110 Braunschweig EU/1/05/322/001 Radiopharmaceutical precursor, solution pending 23.1.2006 19.1.2006 CUBICIN Daptomycin Chiron Corporation Limited, Symphony House, 7 Cowley Business Park, High Street, Cowley, UXBRIDGE, UB8 2AD, United Kingdom EU/1/05/328/001-002 Powder for concentrate for solution for infusion Pending 23.1.2006 24.1.2006 Naglazyme Recombinant human N-acetylgalactosamine 4-sulfatase (galsulfase) BioMarin Europe Limited, 29, Earlsfort Terrace, Dublin 2, Ireland EU/1/05/324/001 Concentrate for solution for infusion A16AB 26.1.2006 24.1.2006 Ionsys Fentanyl Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse EU/1/05/326/001 Iontophoretic transdermal system N02A B03 26.1.2006 24.1.2006 Exubera Insulin human Aventis/Pfizer EEIG, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/05/327/001-017 Inhalation powder, pre-dispensed pending 26.1.2006 31.1.2006 Macugen pegaptanib sodium Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/05/325/001 Solution for injection S01XA17 2.2.2006

— 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 9.1.2006 Arava Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/99/118/001-010 11.1.2006 9.1.2006 Karvea Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UD8 1DH, United Kingdom EU/1/97/049/001-033 11.1.2006 9.1.2006 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC, 174, avenue de France, F-75013 Paris EU/1/97/046/001-033 11.1.2006 9.1.2006 Rapamune Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/01/171/001-012 11.1.2006 9.1.2006 Aerius Schering Plough Europe, Rue de Stalle 73, B-1180 Bruxelles — Stallestraat 73, B-1180 Brussel EU/1/00/160/001-034 11.1.2006 9.1.2006 Azomyr Schering Plough Europe, Rue de Stalle 73, B-1180 Bruxelles — Stallestraat 73, B-1180 Brussel EU/1/00/157/001-034 11.1.2006 9.1.2006 Neoclarityn Schering Plough Europe, Rue de Stalle 73, B-1180 Bruxelles — Stallestraat 73, B-1180 Brussel EU/1/00/161/001-034 11.1.2006 13.1.2006 Bondronat Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/96/012/009-010 17.1.2006 13.1.2006 Humalog Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland EU/1/96/007/001-008 EU/1/96/007/010-030 17.1.2006 13.1.2006 PritorPlus Glaxo Group Ltd, Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/215/001-010 17.1.2006 13.1.2006 Hycamtin SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/96/027/001 EU/1/96/027/003-005 17.1.2006 13.1.2006 Zonegran Eisai Limited, 3, Shortlands, London W6 8EE, United Kingdom EU/1/04/307/001-010 17.1.2006 19.1.2006 Aldurazyme Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/03/253/001-003 23.1.2006 19.1.2006 Rebif Serono Europe Ltd, 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063/007 24.1.2006 19.1.2006 Velcade Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse EU/1/04/274/001 23.1.2006 19.1.2006 Ceprotin Baxter AG, Industriestraße 67, A-1220 Vienna EU/1/01/190/001-002 23.1.2006 20.1.2006 Humira Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/256/001-006 24.1.2006 20.1.2006 Tamiflu Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/02/222/001-002 24.1.2006 20.1.2006 Iscover Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UD8 1DH, United Kingdom EU/1/98/070/001a-b, 002a-b, 003a-b, 004a-b 24.1.2006 20.1.2006 Plavix Sanofi Pharma Bristol-Myers Squibb SNC, 174, avenue de France, F-75013 Paris EU/1/98/069/001a-b, 002a-b, 003a-b, 004a-b 24.1.2006 20.1.2006 Azomyr Schering Plough Europe, Rue de Stalle 73, B-1180 Bruxelles — Stallestraat 73, B-1180 Brussel EU/1/00/157/022-034 24.1.2006 20.1.2006 Aerius Schering Plough Europe, Rue de Stalle 73, B-1180 Bruxelles — Stallestraat 73, B-1180 Brussel EU/1/00/160/022-034 24.1.2006 20.1.2006 Neoclarityn Schering Plough Europe, Rue de Stalle 73 B-1180 Bruxelles — Stallestraat 73, B-1180 Brussel EU/1/00/161/022-034 24.1.2006 24.1.2006 Luveris Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/155/001-006 26.1.2006 24.1.2006 Taxotere Aventis Pharma S.A., 20, avenue Raymond Aron, F-92165 Antony Cedex EU/1/95/002/001-002 26.1.2006 24.1.2006 Infanrix Penta GlaxoSmithKline Biologicals S.A., rue de l'Institut 89, B-1330 Rixensart EU/1/00/153/001-010 26.1.2006 24.1.2006 Infanrix Hexa GlaxoSmithKline Biologicals S.A., rue de l'Institut 89, B-1330 Rixensart EU/1/00/152/001-018 26.1.2006 25.1.2006 AZILECT Teva Pharma GmbH, Kandelstraße 10, D-79199 Kirchzarten EU/1/04/304/001-007 30.1.2006 25.1.2006 Tamiflu Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/02/222/001-002 27.1.2006 25.1.2006 Dynastat Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United-Kingdom EU/1/02/209/001-008 30.1.2006 25.1.2006 Invanz Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/02/216/001-002 27.1.2006 25.1.2006 REYATAZ Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom EU/1/03/267/001-007 27.1.2006 26.1.2006 PEGASYS Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221/001-010 30.1.2006 30.1.2006 Avandamet SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/03/258/001-022 1.2.2006 30.1.2006 Alimta Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/290/001 1.2.2006 30.1.2006 Ferriprox Apotex Europe Ltd, Rowan House, 41 London Street, Reading, Berkshire, RG1 4PS, United Kingdom EU/1/99/108/001 6.2.2006 30.1.2006 Trudexa Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/257/001-006 1.2.2006 31.1.2006 NeoSpect Amersham Health AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, N-0401 Oslo EU/1/00/154/001-002 2.2.2006 31.1.2006 Betaferon Schering AG Pharma, D-13342 Berlin EU/1/95/003/003-004 2.2.2006 31.1.2006 Simulect Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/084/001-002 2.2.2006 31.1.2006 Ovitrelle Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/165/001-007 7.2.2006 31.1.2006 Vfend Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212/001-026 2.2.2006

— 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 19.1.2006 Zubrin Schering-Plough Limited, Schering-Plough House, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom EU/2/00/028/002-008 23.1.2006 20.1.2006 Nobivac Bb Intervet International B.V., Wim de Körverstraat 35, PO Box 31, 5830 AA Boxmeer, Nederland EU/1/00/161/001 24.1.2006 20.1.2006 Purevax FeLV Merial, 29, Avenue Tony Garnier, F-69007 Lyon EU/2/00/019/001-003 EU/2/00/019/005-007 24.1.2006 25.1.2006 METACAM Boehringer Ingelheim Vetmedica GmbH, D-55216 Ingelheim am Rhein EU/2/97/004/007-008 EU/2/97/004/014-015 27.1.2006 25.1.2006 Clomicalm Novartis Tiergesundheit GmbH, Zielstattstrasse 40, D-81379 München EU/2/98/007/001-003 27.1.2006

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, 30.4.2004, p. 1.