EN Official Journal of the European Union C 220/5

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2008 to 31 July 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 220/03)

— 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 2.7.2008 RELISTOR Methylnaltrexone bromide Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/08/463/001-003 Solution for injection (Non applicable) 4.7.2008 3.7.2008 Trevaclyn Nicotinic acid/laropiprant Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/08/458/001-011 Modified-release tablet C10AD52 7.7.2008 3.7.2008 Pelzont Nicotinic acid/laropiprant Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/08/460/001-011 Modified-release tablet C10AD52 7.7.2008 3.7.2008 Tredaptive Nicotinic acid/laropiprant Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/08/459/001-011 Modified-release tablet C10AD52 7.7.2008 9.7.2008 Latixa Ranolazine CV Therapeutics Europe Limited 15 Meadway Court Rutherford Close Stevenage Hertfordshire SG1 2EF United Kingdom EU/1/08/462/001-006 Prolonged release tablet C01EB18 14.7.2008 11.7.2008 Firazyr Icatibant Jerini AG Invalidenstr. 130 D-10115 Berlin EU/1/08/461/001 Solution for injection (Non applicable) 15.7.2008 16.7.2008 Clopidogrel BMS Clopidogrel BRISTOL MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/08/464/001-017 Film-coated tablet B01AC04 18.7.2008 16.7.2008 Clopidogrel Winthrop Clopidogrel Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/08/465/001-017 Film-coated tablet B01AC04 18.7.2008 16.7.2008 Janumet Sitagliptin/metformin hydrochloride Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United-Kingdom EU/1/08/455/001-014 Film-coated tablet A10BD07 18.7.2008 16.7.2008 Efficib Sitagliptin/metformin hydrochloride Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/08/457/001-014 Film-coated tablet A10BD07 18.7.2008 16.7.2008 Velmetia Sitagliptin/metformin hydrochloride Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/08/456/001-014 Film-coated tablet A10BD07 18.7.2008 25.7.2008 Bridion Sugammadex N.V. Organon Kloosterstraat 6 5349 AB Oss Nederland EU/1/08/466/001-002 Solution for injection V03AB35 29.7.2008 25.7.2008 Doribax Doripenem Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/08/467/001 Powder for solution for infusion J01DH04 29.7.2008

— 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 2.7.2008 PritorPlus Bayer HealthCare AG D-51368 Leverkusen EU/1/02/215/001-021 7.7.2008 2.7.2008 Epivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/96/015/001-005 4.7.2008 2.7.2008 Pritor Bayer HealthCare AG D-51368 Leverkusen EU/1/98/089/001-022 4.7.2008 2.7.2008 INCRELEX Tercica Europe Limited Riverside One Sir John Rogerson's Quay Dublin 2 Ireland EU/1/07/402/001 4.7.2008 3.7.2008 Kinzalkomb Bayer HealthCare AG D-51368 Leverkusen EU/1/02/214/001-015 7.7.2008 3.7.2008 Micardis Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/98/090/001-020 7.7.2008 3.7.2008 Aranesp Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/01/185/001-073 7.7.2008 3.7.2008 Nespo Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/01/184/001-073 7.7.2008 4.7.2008 Mabthera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/98/067/001-002 8.7.2008 4.7.2008 Rotarix GlaxoSmithKline Biologicals s.a rue de l'Institut, 89 B-1330 Rixensart EU/1/05/330/001-004 8.7.2008 4.7.2008 MabCampath Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/01/193/001-002 8.7.2008 4.7.2008 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/001 8.7.2008 4.7.2008 MicardisPlus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/02/213/001-023 8.7.2008 4.7.2008 Kinzalmono Bayer HealthCare AG D-51368 Leverkusen EU/1/98/091/001-014 8.7.2008 4.7.2008 Zometa Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/176/001-006 8.7.2008 7.7.2008 TOVIAZ Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/07/386/001-012 9.7.2008 7.7.2008 Vasovist Bayer Schering Pharma AG D-13342 Berlin EU/1/05/313/001-009 9.7.2008 7.7.2008 Kepivance Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/05/314/001 9.7.2008 7.7.2008 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 9.7.2008 7.7.2008 Invirase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/026/001-002 9.7.2008 7.7.2008 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/222/001-004 9.7.2008 7.7.2008 Siklos Addmedica 84, rue d'Amsterdam F-75009 Paris EU/1/07/397/001 9.7.2008 7.7.2008 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/001-018 9.7.2008 7.7.2008 Aldara Meda AB Pipers väg 2A S-170 73 Solna EU/1/98/080/001 9.7.2008 7.7.2008 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 9.7.2008 8.7.2008 Zalasta KRKA, d.d. Šmarješka cesta 6 SLO-8501 Novo mesto EU/1/07/415/001-056 10.7.2008 8.7.2008 Binocrit Sandoz GmbH Biochemiestraße 10 A-6250 Kundl EU/1/07/410/001-020 10.7.2008 8.7.2008 Fuzeon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/252/001-003 10.7.2008 8.7.2008 Epoetin alfa Hexal HEXAL Biotech Forschungs GmbH Industriestraße 25 D-83607 Holzkirchen EU/1/07/411/001-020 10.7.2008 8.7.2008 Busilvex Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex EU/1/03/254/002 10.7.2008 9.7.2008 Rasilez Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/405/001-020 11.7.2008 9.7.2008 Exubera Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/05/327/001-018 11.7.2008 9.7.2008 Cholestagel Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/03/268/001-003 11.7.2008 9.7.2008 Circadin RAD Neurim Pharmaceuticals EEC Limited 6 Fortuna Court Calleva Park Aldermaston Berkshire RG7 8UB United Kingdom EU/1/07/392/001-002 11.7.2008 9.7.2008 Pedea Orphan Europe SARL Immeuble Le Wilson 70, avenue du Général de Gaulle F-92800 Puteaux EU/1/04/284/001 11.7.2008 9.7.2008 Sprimeo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/407/001-020 11.7.2008 9.7.2008 Enviage Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/406/001-020 11.7.2008 9.7.2008 Tekturna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/408/001-020 11.7.2008 9.7.2008 Riprazo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/409/001-020 11.7.2008 10.7.2008 Bonviva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/265/003-004 14.7.2008 10.7.2008 Bondenza Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/266/003-004 14.7.2008 10.7.2008 Optaflu Novartis Vaccines and Diagnostics GmbH & Co. KG Emil-von-Behring-Straße 76 D-35041 Marburg EU/1/07/394/001-009 14.7.2008 10.7.2008 ViraferonPeg Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/00/132/001-050 14.7.2008 10.7.2008 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 14.7.2008 10.7.2008 Silgard Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/06/358/001-021 14.7.2008 10.7.2008 PegIntron Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/00/131/001-050 14.7.2008 10.7.2008 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/357/001-021 15.7.2008 11.7.2008 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/99/110/001-009 15.7.2008 11.7.2008 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/99/111/001-011 15.7.2008 11.7.2008 Liprolog Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/01/195/022-027 15.7.2008 17.7.2008 Zimulti Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/345/001-011 23.7.2008 17.7.2008 Humira Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 23.7.2008 17.7.2008 Erbitux Merck KGaA Frankfurter Straße 250 D-64271 Darmstadt EU/1/04/281/001-005 23.7.2008 17.7.2008 ACOMPLIA Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/344/001-011 23.7.2008 22.7.2008 Silapo STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel EU/1/07/432/001-022 24.7.2008 22.7.2008 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/06/363/001-009 24.7.2008 22.7.2008 CUBICIN Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/05/328/001-002 24.7.2008 23.7.2008 Prandin Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/00/162/003-005 EU/1/00/162/009-011 EU/1/00/162/015-017 EU/1/00/162/019-021 25.7.2008 23.7.2008 Exjade Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/356/001-006 25.7.2008 23.7.2008 NovoNorm Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/98/076/004-006 EU/1/98/076/011-013 EU/1/98/076/018-020 EU/1/98/076/022-024 25.7.2008 23.7.2008 Quadramet CIS bio international Boîte Postale 32 F-91192 Gif-sur-Yvette EU/1/97/057/001 25.7.2008 24.7.2008 Keppra UCB Pharma S.A. Allée de la Recherche, 60/Researchdreef, 60 B-1070 Bruxelles/B-1070 Brussel EU/1/00/146/030 28.7.2008 25.7.2008 Keppra UCB Pharma S.A. Allée de la Recherche, 60/Researchdreef, 60 B-1070 Bruxelles/B-1070 Brussel EU/1/00/146/001-030 29.7.2008 25.7.2008 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/03/267/001-009 29.7.2008 25.7.2008 Trisenox Cephalon Europe 5, rue Charles Martigny F-94700 Maisons Alfort Cedex EU/1/02/204/001 29.7.2008 25.7.2008 Myfenax Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland EU/1/07/438/001-004 29.7.2008 25.7.2008 Valtropin BioPartners GmbH Eisenstraße 3 D-65428 Rüsselsheim EU/1/06/335/001 — 25.7.2008 Zeffix Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/99/114/001-003 29.7.2008 25.7.2008 Mycophenolate mofetil Teva Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland EU/1/07/439/001-004 29.7.2008 28.7.2008 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/296/001-009 30.7.2008 28.7.2008 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 30.7.2008 28.7.2008 NovoMix Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/00/142/004-005 EU/1/00/142/009-022 30.7.2008 28.7.2008 Xeristar Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/04/297/001-008 30.7.2008 28.7.2008 Zostavax Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/341/001-013 30.7.2008 28.7.2008 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/99/125/001-016 30.7.2008 28.7.2008 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/001 30.7.2008 28.7.2008 Vivanza Bayer AG D-51368 Leverkusen EU/1/03/249/001-012 30.7.2008 28.7.2008 Levitra Bayer AG D-51368 Leverkusen EU/1/03/248/001-012 30.7.2008 28.7.2008 Ventavis Bayer Schering Pharma AG Müllerstraße 170-178 D-13342 Berlin EU/1/03/255/001-006 30.7.2008 28.7.2008 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 30.7.2008 29.7.2008 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/220/001-005 31.7.2008 29.7.2008 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 31.7.2008 29.7.2008 Velcade Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/04/274/001-002 31.7.2008 29.7.2008 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 31.7.2008 29.7.2008 INCRELEX Tercica Europe Limited Riverside One Sir John Rogerson's Quay Dublin 2 Ireland EU/1/07/402/001 31.7.2008 29.7.2008 Naglazyme BioMarin Europe Limited Axtell House 23-24 Warwick Street London W1B 5NQ United Kingdom EU/1/05/324/001-002 31.7.2008 29.7.2008 Circadin RAD Neurim Pharmaceuticals EEC Limited 6 Fortuna Court Calleva Park Aldermaston Berkshire RG7 8UB United Kingdom EU/1/07/392/001-002 31.7.2008 29.7.2008 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 31.7.2008 29.7.2008 Pylobactell Torbet Laboratories Limited Unit 14D Wendover Road Rackheath Industrial Estate Norwich Norfolk NR13 6LH United Kingdom EU/1/98/064/001 1.8.2008 31.7.2008 Revlimid Celgene Europe Limited Morgan House Madeira Walk Windsor Berkshire SL4 1EP United Kingdom EU/1/07/391/001-004 5.8.2008 31.7.2008 DuoTrav Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/06/338/001-003 5.8.2008 31.7.2008 ADROVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/06/364/001-009 5.8.2008

— 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 8.7.2008 Reconcile Fluoxétine Eli Lilly and Company Ltd Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom EU/2/08/080/001-004 Chewable tablets QN06AB03 16.7.2008 24.7.2008 ZACTRAN Gamithromycine MERIAL 29, avenue Tony Garnier F-69007 Lyon EU/2/08/082/001-003 Solution for injection QJ01FA95 28.7.2008

— 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 11.7.2008 Equilis Te Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/05/055/001-002 15.7.2008 11.7.2008 Equilis Prequenza Te Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/05/057/001-004 15.7.2008 11.7.2008 ProMeris Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp Nederland EU/2/06/064/001-004 15.7.2008 31.7.2008 Poulvac FluFend H5N3 RG Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH United Kingdom EU/2/06/060/001-002 5.8.2008

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.