EN Official Journal of the European Union C 56/5

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008

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

(2008/C 56/07)

— 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 10.1.2008 TESAVEL Sitagliptin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/435/001-018 Film-coated tablet A10BH01 14.1.2008 11.1.2008 Abraxane Paclitaxel Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ United Kingdom EU/1/07/428/001 Powder for suspension for infusion L01CD01 15.1.2008 11.1.2008 IVEMEND Fosaprepitant dimeglumine Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/437/001-002 Powder for solution for infusion (Non applicable) 16.1.2008 11.1.2008 Avamys Fluticasone furoate Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/07/434/001-003 Nasal spray suspension R01AD12 16.1.2008

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Rejected

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 11.1.2008 Natalizumab Elan Pharma Ltd Norton Green Road Stevenage Herts SG1 2BA United Kingdom — 15.1.2008

— 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 8.1.2008 Puregon Organon N.V. Kloosterstraat 6 Postbus 20 5340 BH Oss Nederland EU/1/96/008/001-041 10.1.2008 8.1.2008 DepoCyte SkyePharma PLC 105 Piccadilly London W1J 7NJ United Kingdom Pacira Limited MG House Rumbolds Hill Midhurst West Sussex GU29 9BY United Kingdom EU/1/01/187/001 10.1.2008 10.1.2008 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/001 14.1.2008 10.1.2008 Velcade Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/04/274/001 14.1.2008 10.1.2008 Viramune Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/055/001-003 14.1.2008 10.1.2008 Viracept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/054/001 EU/1/97/054/004-005 14.1.2008 10.1.2008 Angiox The Medicines Company UK Ltd Suite B Park House 11 Milton Park Abingdon Oxfordshire OX14 4RS United Kingdom EU/1/04/289/001-002 14.1.2008 11.1.2008 Thelin Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom EU/1/06/353/001-005 15.1.2008 11.1.2008 Irbesartan HCT BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/06/369/001-028 15.1.2008 14.1.2008 Optaflu Novartis Vaccines and Diagnostics GmbH & Co. KG Emil-von-Behring-Straße 76 D-35041 Marburg EU/1/07/394/001-006 16.1.2008 17.1.2008 Zyprexa Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/96/022/002 EU/1/96/022/004 EU/1/96/022/006 EU/1/96/022/008-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-034 21.1.2008 17.1.2008 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/99/125/001-016 21.1.2008 17.1.2008 Neulasta Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/02/227/001-003 21.1.2008 17.1.2008 Neupopeg Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/02/228/001-003 21.1.2008 17.1.2008 Evoltra Bioenvision Limited Bassett House 5 Southwell Park Road Camberley Surrey GU15 3PU United Kingdom EU/1/06/334/001-004 21.1.2008 17.1.2008 Humira Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 21.1.2008 17.1.2008 Twinrix Adult GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/96/020/001-009 21.1.2008 18.1.2008 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 22.1.2008 18.1.2008 Dynepo Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/02/211/001-005 EU/1/02/211/010-012 22.1.2008 18.1.2008 Zerene Wyeth Research (UK) Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Meda AB Pipers väg 2A S-170 09 Solna EU/1/99/099/001-006 22.1.2008 18.1.2008 Orgalutran N.V. Organon P.O. Box 20 Kloosterstraat 6 5340 BH Oss Nederland EU/1/00/130/001-002 22.1.2008 18.1.2008 Mabthera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/98/067/001-002 22.1.2008 18.1.2008 Tarceva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/05/311/001-003 22.1.2008 22.1.2008 Alimta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/290/001-002 25.1.2008 22.1.2008 Twinrix Paediatric GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/97/029/001-010 24.1.2008 25.1.2008 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/04/300/001-002 29.1.2008 25.1.2008 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/04/295/001 29.1.2008 25.1.2008 Osseor Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine EU/1/04/287/001-006 29.1.2008 25.1.2008 Protelos Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine EU/1/04/288/001-006 29.1.2008 25.1.2008 Exubera Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/327/001-018 29.1.2008 25.1.2008 Galvus Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/414/001-017 29.1.2008 25.1.2008 SUTENT Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/347/001-003 29.1.2008 25.1.2008 Advagraf Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp Nederland EU/1/07/387/001-010 29.1.2008 25.1.2008 Onsenal Pharmacia-Pfizer EEIG Ramsgate Road Sandwich CT13 9NJ United Kingdom Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/03/259/001-006 29.1.2008 28.1.2008 Irbesartan Hydrochlorothiazide Winthrop SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174, avenue de France F-75013 Paris EU/1/06/377/001-028 30.1.2008 28.1.2008 Macugen Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/325/002 30.1.2008 28.1.2008 Vfend Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/02/212/001-026 30.1.2008 28.1.2008 ViraferonPeg Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/00/132/001-050 30.1.2008 28.1.2008 PegIntron Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/00/131/001-050 30.1.2008 28.1.2008 IntronA Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/99/127/001-044 30.1.2008 28.1.2008 Viraferon Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/99/128/001-037 30.1.2008 28.1.2008 Agenerase Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/00/148/001-004 30.1.2008 28.1.2008 BYETTA Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/06/362/001-004 30.1.2008 29.1.2008 Liprolog Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/01/195/001-021 31.1.2008 31.1.2008 Dynastat Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/02/209/001-008 4.2.2008 31.1.2008 Xeloda Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/00/163/001-002 4.2.2008 31.1.2008 Humalog Eli Lilly Nederland B.V. 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/1/96/007/023-038 4.2.2008 31.1.2008 Naglazyme BioMarin Europe Limited Axtell House 23-24 Warwick Street London W1B 5NQ United Kingdom EU/1/05/324/001 4.2.2008

— Issuing of a marketing authorization (Article 38 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 10.1.2008 Rheumocam Meloxicam Chanelle Pharmaceuticals Manufacturing Limited Loughrea Co. Galway Ireland EU/2/07/078/001-003 Oral suspension QM01AC06 15.1.2008 31.1.2008 Nobilis Influenza H5N6 Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), inducing an HI titre of ≥ 6,0 log2 as tested according to the potency test Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/07/076/001-004 Emulsion for injection QI01AA23 4.2.2008

— 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 3.1.2008 ProMeris Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp Nederland EU/2/06/064/001-004 7.1.2008 10.1.2008 Nobilis OR Inac Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/02/036/001-002 14.1.2008 11.1.2008 ProteqFlu Te Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/03/038/005 15.1.2008 14.1.2008 ProteqFlu Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/03/037/005 16.1.2008 15.1.2008 Dicural Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp Nederland EU/2/97/003/001-018 17.1.2008 17.1.2008 Cerenia Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/06/062/001-005 21.1.2008 22.1.2008 Purevax FelV Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/00/019/005-007 25.1.2008 22.1.2008 Purevax RCP FelV Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/04/048/001-002 25.1.2008 22.1.2008 Purevax RCCh Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/04/049/001-002 25.1.2008 22.1.2008 Purevax RCPCH FelV Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/04/047/001-002 25.1.2008 22.1.2008 Purevax RCPCh Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/04/050/001-002 25.1.2008 22.1.2008 ProteqFlu Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/03/037/005 25.1.2008 22.1.2008 ProteqFlu-Te Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/03/038/005 25.1.2008 22.1.2008 Purevax RC Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/04/051/001-002 25.1.2008 25.1.2008 Purevax RCP Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/04/052/001-002 29.1.2008

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.