EN Official Journal of the European Union C 73/9

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2007 to 28 February 2007

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

(2007/C 73/08)

— 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 12.2.2007 Prezista darunavir Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse EU/1/06/380/001 Film-coated tablet J05AE10 14.2.2007 15.2.2007 Cystadane Betaine anhydrous Orphan Europe SARL Immeuble ‘Le Guillaumet’ F-92046 Paris-La-Défense EU/1/06/379/001 Oral powder A16A A06 19.2.2007

— 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 1.2.2007 Xyrem UCB Pharma Ltd 208 Bath Road Slough Berks SL1 3WE United Kingdom EU/1/05/312/001 5.2.2007 5.2.2007 Aldurazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/03/253/001-003 7.2.2007 9.2.2007 ReFacto Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/103/001-004 13.2.2007 12.2.2007 Replagal Shire Human Genetic Therapies AB Rinkebyvägen 11B S-182 36 Danderyd EU/1/01/189/001-006 14.2.2007 15.2.2007 BeneFIX Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/97/047/001-003 19.2.2007 15.2.2007 Trisenox Cephalon UK Ltd 20 Alan Turing Road Surrey Research Park Guildford Surrey GU2 7YF United Kingdom EU/1/02/204/001 19.2.2007 15.2.2007 Fabrazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/01/188/001-006 19.2.2007 20.2.2007 Ammonaps Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm EU/1/99/120/001-004 22.2.2007 20.2.2007 Zavesca Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/238/001 22.2.2007 20.2.2007 Azopt Alcon Laboratories (UK) Ltd Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/00/129/001-003 22.2.2007 20.2.2007 Erbitux Merck KGaA Frankfurter Straße 250 D-64293 Darmstadt EU/1/04/281/002-005 22.2.2007 20.2.2007 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo Ireland EU/1/02/205/001-002 26.2.2007 21.2.2007 Avonex Biogen Idec Ltd 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kindgom EU/1/97/033/001-003 23.2.2007 23.2.2007 Raptiva Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom EU/1/04/291/001-002 27.2.2007 27.2.2007 Comtess Orion Corporation Orionintie 1 FIN-02200 Espoo EU/1/98/082/001-003 EU/1/98/082/005 1.3.2007 27.2.2007 Comtan Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/081/001-004 1.3.2007 27.2.2007 Norvir Abbott laboratories Ltd Queenborough Kent ME11 5EL United-Kingdom EU/1/96/016/001 EU/1/96/016/003-004 1.3.2007 27.2.2007 Erbitux Merck KGaA Frankfurter Straße 250 D-64293 Darmstadt EU/1/04/281/001-005 1.3.2007 27.2.2007 Tarceva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/05/311/001-003 1.3.2007 27.2.2007 Pritor Bayer HealthCare AG D-51368 Leverkusen EU/1/98/089/001-022 1.3.2007 27.2.2007 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 1.3.2007 27.2.2007 Levemir Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/04/278/001-009 1.3.2007 27.2.2007 Zeffix Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/99/114/001-003 1.3.2007 28.2.2007 EMEND Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/03/262/001-008 2.3.2007 28.2.2007 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 2.3.2007 28.2.2007 Kepivance Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/05/314/001 2.3.2007 28.2.2007 PritorPlus Bayer HealthCare AG D-51368 Leverkusen EU/1/02/215/001-014 2.3.2007 28.2.2007 Osseor Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine EU/1/04/287/001-006 2.3.2007 28.2.2007 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 2.3.2007 28.2.2007 Protelos Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine EU/1/04/288/001-006 2.3.2007 28.2.2007 Agenerase Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/00/148/001-004 2.3.2007 28.2.2007 Zavesca Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/238/001 2.3.2007 28.2.2007 Viread Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom EU/1/01/200/001 2.3.2007

— 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 9.2.2007 Stronghold PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/99/014/001-012 13.2.2007 20.2.2007 Nobivac Piro Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/04/046/001-003 22.2.2007 20.2.2007 DRAXXIN PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/03/041/001-005 22.2.2007 20.2.2007 Metacam Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein EU/2/97/004/003-005 EU/2/97/004/012-013 EU/2/97/004/021-025 22.2.2007 23.2.2007 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/001-006 27.2.2007 27.2.2007 Fevaxyn Pentofel Fort Dodge Laboratories Ireland Finisklin Industrial Estate — Sligo Ireland EU/2/96/002/001-003 2.3.2007

(1) OJ L 136, 30.4.2004, p. 1.