EN Official Journal of the European Union C 305/3

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2008 to 31 October 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 305/04)

— 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 1.10.2008 Tadalafil Lilly Tadalafil Eli Lilly Nederlan B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/08/476/001-004 Film-coated tablet G04B E08 3.10.2008 6.10.2008 EVICEL Human fibrinogen/ human thrombin OMRIX biopharmaceuticals S.A./N.V. 200 Chaussée de Waterloo/Waterloosesteenweg 200 B-1640 Rhode-St-Genèse/Sint-Genesius-Rode EU/1/08/473/001-003 Solutions for sealant B02BC 9.10.2008 6.10.2008 Fluticasone furoate GSK Fluticasone furoate Glaxo Group Ltd Greenford Middlesex UB6 ONN United Kingdom EU/1/08/474/001-003 Nasal spray suspension R01AD12 8.10.2008 7.10.2008 Olanzapine Mylan Olanzapine Generics [UK] Limited Station Close Potters Bar Hertfordshire EN6 1TL United Kingdom EU/1/08/475/001-034 Film-coated tablet N05AH03 9.10.2008 7.10.2008 Ceplene Histamine dihydrochloride EpiCept GmbH Goethestraße 4 D-80336 München EU/1/08/477/001 Solution for injection L03AX14 9.10.2008 8.10.2008 Duloxetine Boehringer Ingelheim Duloxetine Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/08/471/001-012 Gastro-resistant capsule N06AX21 10.10.2008

— 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 1.10.2008 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/98/085/001-034 3.10.2008 1.10.2008 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/086/001-034 3.10.2008 8.10.2008 Simulect Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/084/001-002 10.10.2008 9.10.2008 Tasmar Valeant Pharmaceuticals Limited Cedarwood Chineham Business Park Crockford lane Basingstoke RG24 8WD United Kingdom EU/1/97/044/001-008 14.10.2008 13.10.2008 Yondelis Pharma Mar, S.A. Avda. de los Reyes 1 Polígono Industrial La Mina E-28770 Colmenar Viejo (Madrid) EU/1/07/417/001-002 15.10.2008 13.10.2008 HBVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/01/183/030-032 15.10.2008 13.10.2008 Galvus Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/414/018 15.10.2008 14.10.2008 DepoCyte Pacira Limited MG House Rumbolds Hill Midhurst West Sussex GU29 9BY United Kingdom EU/1/01/187/001 16.10.2008 20.10.2008 Onsenal Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/03/259/001-006 22.10.2008 20.10.2008 Thalidomide Pharmion Celgene Europe Limited Riverside House Riverside Walk Windsor SL4 1NA United Kingdom EU/1/08/443/001 22.10.2008 Pharmion Ltd Riverside House Riverside Walk Windsor SL4 1NA United Kingdom 21.10.2008 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 23.10.2008 21.10.2008 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 23.10.2008 22.10.2008 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn EU/1/07/412/001-020 24.10.2008 23.10.2008 NeoRecormon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/031/019-046 27.10.2008 23.10.2008 Cellcept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/005/001-006 27.10.2008 24.10.2008 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/001 28.10.2008 24.10.2008 Vectibix Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/07/423/001-003 28.10.2008 27.10.2008 Myocet Cephalon Europe 5, Rue Charles Martigny F-94700 Maisons Alfort EU/1/00/141/001 29.10.2008 27.10.2008 Revlimid Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA United Kingdom EU/1/07/391/001-004 29.10.2008 27.10.2008 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/03/267/001-010 29.10.2008 27.10.2008 Lucentis Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/374/001 29.10.2008 28.10.2008 Nespo Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/01/184/001-073 30.10.2008 28.10.2008 RotaTeq Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/348/001-002 30.10.2008 28.10.2008 CELSENTRI Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/07/418/001-010 30.10.2008 28.10.2008 Valtropin BioPartners GmbH Eisenstraße 3 D-65428 Rüsselsheim EU/1/06/335/001 5.11.2008 28.10.2008 Revatio Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/318/001 30.10.2008 28.10.2008 Zavesca Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/238/001 30.10.2008 28.10.2008 Advagraf Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp Nederland EU/1/07/387/001-010 30.10.2008 28.10.2008 Agenerase Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/00/148/001-004 30.10.2008 28.10.2008 Ketek Aventis Pharma S.A. 20, avenue Raymond Aron F-92160 Antony Cedex EU/1/01/191/001-005 30.10.2008 28.10.2008 Aranesp Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/01/185/001-022 EU/1/01/185/031-073 30.10.2008 29.10.2008 Parareg Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/04/293/001-012 31.10.2008 29.10.2008 Mimpara Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/04/292/001-012 31.10.2008 29.10.2008 Binocrit Sandoz GmbH Biochemiestrasse 10 A-Kundl 6250 EU/1/07/410/001-020 31.10.2008 29.10.2008 Betaferon Bayer Schering Pharma AG Müllerstraße 170-178 D-13342 Berlin EU/1/95/003/003-008 31.10.2008 29.10.2008 Crixivan Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/96/024/001-005 EU/1/96/024/007-008 EU/1/96/024/010 31.10.2008 29.10.2008 Epoetin alfa Hexal HEXAL Biotech Forschungs GmbH Industriestraße 25 D-83607 Holzkirchen EU/1/07/411/001-020 31.10.2008 30.10.2008 Rapamune Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/01/171/001 EU/1/01/171/007-010 4.11.2008 30.10.2008 Kaletra Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/001-006 4.11.2008 30.10.2008 Tysabri Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland EU/1/06/346/001 4.11.2008 30.10.2008 Tygacil Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/06/336/001 4.11.2008 30.10.2008 Eucreas Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/425/001-018 4.11.2008 30.10.2008 PEGASYS Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/221/001-010 4.11.2008 30.10.2008 Infanrix Penta GlaxoSmithKline Biologicals s.a. rue de l'Institut, 89 B-1330 Rixensart EU/1/00/153/001-010 4.11.2008 30.10.2008 Hycamtin SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/96/027/001 EU/1/96/027/003-007 4.11.2008 30.10.2008 Myozyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/06/333/001-003 4.11.2008 30.10.2008 SUTENT Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/347/001-006 4.11.2008 31.10.2008 Sebivo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/388/001-002 4.11.2008 31.10.2008 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/357/001-021 4.11.2008 31.10.2008 Silgard Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/06/358/001-021 4.11.2008 31.10.2008 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/222/001-004 4.11.2008 31.10.2008 Invirase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/026/001-002 4.11.2008 31.10.2008 CELSENTRI Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/07/418/001-010 4.11.2008 31.10.2008 Xeloda Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/00/163/001-002 4.11.2008 31.10.2008 Rebetol Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/1180 Brussel EU/1/99/107/001-005 4.11.2008 31.10.2008 Galvus Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/414/001-010 EU/1/07/414/018 4.11.2008 31.10.2008 Infanrix hexa GlaxoSmithKline Biologicals s.a. rue de l'Institut, 89 B-1330 Rixensart EU/1/00/152/001-018 4.11.2008 31.10.2008 Insulin human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/06/368/088-142 4.11.2008 31.10.2008 ViraferonPeg Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/1180 Brussel EU/1/00/132/001-050 4.11.2008 31.10.2008 PegIntron Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/1180 Brussel EU/1/00/131/001-050 4.11.2008

— 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 13.10.2008 Viraferon Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/1180 Brussel EU/1/99/128/001-037 15.10.2008 29.10.2008 Forcaltonin Unigene UK Limited 191 Sparrows Herne Bushey Heath Hertfordshire WD23 1AJ United Kingdom EU/1/98/093/002 3.11.2008

— 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 9.10.2008 SevoFlo Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/2/02/035/007 14.10.2008 13.10.2008 Vaxxitek HVT + IBD Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/02/032/001 15.10.2008 17.10.2008 Previcox Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/04/045/001-006 21.10.2008 20.10.2008 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/001-002 22.10.2008 21.10.2008 Convenia Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/06/059/001 23.10.2008

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.