EN Official Journal of the European Union C 78/15

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2006 to 28 February 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 78/03)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 15.2.2006 Neupro Rotigotine Schwarz Pharma Ltd Shannon Industrial Estate Co.Clare Ireland EU/1/05/331/001-013 Transdermal patch N04BC09 17.2.2006 21.2.2006 Rotarix Rotavirus vaccine, live GlaxoSmithKline Biologicals SA rue de l'Institut 89 B-1330 Rixensart EU/1/05/330/001-004 Powder and solvent for oral suspension J07BH01 23.2.2006

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 2.2.2006 Fareston Orion Corporation Orionintie 1 FIN-02200 Espoo EU/1/96/004/001-002 6.2.2006 9.2.2006 NovoSeven Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/96/006/001-003 13.2.2006 9.2.2006 Aerius Schering Plough Europe Rue de Stalle, 73, Stallestraat, 73 B-1180 Brussel/Bruxelles EU/1/00/160/001-034 13.2.2006 9.2.2006 Neoclarityn Schering Plough Europe Rue de Stalle, 73, Stallestraat, 73 B-1180 Brussel/Bruxelles EU/1/00/161/001-034 13.2.2006 9.2.2006 Azomyr Schering Plough Europe Rue de Stalle, 73, Stallestraat, 73 B-1180 Brussel/Bruxelles EU/1/00/157/001-034 13.2.2006 9.2.2006 Humalog Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010-011 EU/1/96/007/015-021 EU/1/96/007/023-028 13.2.2006 9.2.2006 Xeloda Roche Registration Limited 40 Broadwater Road Welwyn Garden City Hertfordshire AL7 3AY United Kingdom EU/1/00/163/001-002 13.2.2006 9.2.2006 Replagal TKT Europe AB Rinkebyvägen 11B S-182 36 Danderyd EU/1/01/189/001-006 13.2.2006 9.2.2006 Fasturtec Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/00/170/001-002 13.2.2006 9.2.2006 Kepivance Amgen Europe BV Minervum 7061 4817 ZK Breda Nederland EU/1/05/314/001 13.2.2006 13.2.2006 Metalyse Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/00/169/004-006 15.2.2006 13.2.2006 Fabrazyme Genzyme Europe BV Gooimeer 10 Naarden 1411 DD Nederland EU/1/01/188/001-006 15.2.2006 13.2.2006 Liprolog Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/01/195/001-015 15.2.2006 13.2.2006 InductOs Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/02/226/001 15.2.2006 13.2.2006 HBVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/01/183/020-029 16.2.2006 14.2.2006 Insuman Aventis Pharma Deutschland GmbH Brueningstraße 50 D-65926 Frankfurt am Main EU/1/97/030/030 EU/1/97/030/035 EU/1/97/030/040 EU/1/97/030/045 EU/1/97/030/050 EU/1/97/030/055-084 16.2.2006 14.2.2006 Tasmar Valeant Pharmaceuticals Limited Cedarwood Chineham Business Park Crockford lane Basingstoke RG24 8WD United Kingdom EU/1/97/044/001-008 16.2.2006 17.2.2006 Pritor Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/98/089/011-014 EU/1/98/089/017-019 21.2.2006 28.2.2006 Viracept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/054/001 EU/1/97/054/003-006 2.3.2006 28.2.2006 Parareg Dompé Biotec SpA Via San Martino, 12 I-20122 Milano EU/1/04/293/001-012 2.3.2006 28.2.2006 Truvada Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom EU/1/04/305/001 2.3.2006 28.2.2006 TachoSil Nycomed Austria GmbH St.-Peter-Straße 25 A-4020 Linz EU/1/04/277/001-004 2.3.2006 28.2.2006 BeneFIX Wyeth Europa Ltd. Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/97/047/001-003 2.3.2006 28.2.2006 Aranesp Amgen Europe BV Minervum 7061 4817 ZK Breda Nederland EU/1/01/185/001-056 2.3.2006 28.2.2006 Lysodren Laboratoire HRA Pharma 19 rue Frédérick Lemaître F-75020 Paris EU/1/04/273/001 6.3.2006 28.2.2006 Glivec Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/198/001-013 2.3.2006 28.2.2006 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/04/295/001 2.3.2006 28.2.2006 Exelon Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/066/001-018 2.3.2006 28.2.2006 Viread Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom EU/1/01/200/001 2.3.2006 28.2.2006 Telzir Glaxo Group Ltd Greenford Road, Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 2.3.2006 28.2.2006 Nespo Dompé Biotec SpA Via San Martino, 12 I-20122 Milano EU/1/01/184/001-056 2.3.2006 28.2.2006 Rapamune Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead, Berkshire SL6 0PH United Kingdom EU/1/01/171/001-012 2.3.2006 28.2.2006 Mimpara Amgen Europe BV Minervum 7061 4817 ZK Breda Nederland EU/1/04/292/001-012 2.3.2006 28.2.2006 Remicade Centocor BV Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 2.3.2006

— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)

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 2.2.2006 Theryttrex MDS Nordion SA Zoning Industriel B-6220 Fleurus EU/1/02/245/001 6.2.2006 2.2.2006 Daquiran Dr. Karl Thomae GmbH Birkendorfferstr. 65 D-88397 Biberach/Riss EU/1/97/052/001-006 EU/1/97/052/009-010 6.2.2006

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 2.2.2006 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/001-005 6.2.2006 3.2.2006 Econor Novartis Animal Health Austria GmbH Biochemiestraße 10 A-6250 Kundl EU/2/98/010/004-006 EU/2/98/010/017-018 EU/2/98/010/023-024 7.2.2006 8.2.2006 Porcilis AR-T DF Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/00/026/001-004 10.2.2006 8.2.2006 Pirsue PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/00/027/001-003 10.2.2006 13.2.2006 ProteqFlu Te Merial 29 Avenue Tony Garnier F-69007 Lyon EU/2/03/038/005 16.2.2006 13.2.2006 Advasure PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/00/025/001-004 15.2.2006 13.2.2006 ProteqFlu Merial 29 avenue Tony Garnier F-69007 Lyon EU/2/03/037/005 16.2.2006 28.2.2006 Stronghold PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/99/014/001-012 2.3.2006

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 of 30.4.2004, p. 1.