EN Official Journal of the European Union C 132/4

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2008 to 30 April 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 132/03)

— 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 4.4.2008 Effentora Fentanyl citrate Cephalon Europe 5, Rue Charles Martigny F-94700 Maisons Alfort EU/1/08/441/001-010 Buccal tablet N02AB03 9.4.2008 16.4.2008 Thalidomide Pharmion Thalidomide Pharmion Ltd Riverside House Riverside Walk Windsor SL4 1NA United Kingdom EU/1/08/443/001 Capsule, hard L04AX02 18.4.2008 21.4.2008 Volibris Ambrisentan Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/08/451/001-004 Film coated tablets C02KX02 24.4.2008 21.4.2008 Adenuric Febuxostat Ipsen Manufacturing Ireland Ltd (IMIL) Blanchardstown Industrial Park Snugboro Road Dublin 15 Ireland EU/1/08/447/001-004 Film coated tablet M04AA03 23.4.2008 25.4.2008 Mycamine Micafungin Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München EU/1/08/448/001-002 Powder for solution for infusion J02AX05 29.4.2008 25.4.2008 Privigen Human normal immunoglobulin (IVIg) CSL Behring GmbH Emil von Behring Straße 76 D-35041 Marburg EU/1/08/446/001-003 Solution for infusion J06BA02 29.4.2008

— 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 14.4.2008 Mylotarg Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom — 16.4.2008

— 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 1.4.2008 PritorPlus Bayer HealthCare AG D-51368 Leverkusen EU/1/02/215/015-021 3.4.2008 1.4.2008 Kineret Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/02/203/001-004 3.4.2008 1.4.2008 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/251/001-002 4.4.2008 2.4.2008 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/03/247/001-002 4.4.2008 2.4.2008 Zalasta KRKA, d.d. Novo mesto Šmarješka cesta 6 SLO-8501 Novo mesto EU/1/07/415/001-056 4.4.2008 2.4.2008 Osigraft Howmedica International S. de R.L. Division of Stryker Corporation Raheen Industrial Estate Raheen Limerick Ireland EU/1/01/179/001 4.4.2008 4.4.2008 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/98/085/001-034 9.4.2008 4.4.2008 Pergoveris Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/07/396/001-003 9.4.2008 4.4.2008 TachoSil Nycomed Austria GmbH St.-Peter-Straße 25 A-4020 Linz EU/1/04/277/001-004 9.4.2008 4.4.2008 Bondronat Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/012/009-010 9.4.2008 4.4.2008 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/086/001-034 9.4.2008 4.4.2008 Glustin Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/00/151/001-024 9.4.2008 8.4.2008 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 10.4.2008 8.4.2008 Alimta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/290/001-002 10.4.2008 8.4.2008 Inovelon Eisai Limited 3, Shortlands London W6 8EE United Kingdom EU/1/06/378/001-016 10.4.2008 8.4.2008 Rebetol Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/99/107/001-005 10.4.2008 10.4.2008 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/357/001-021 15.4.2008 10.4.2008 Silgard Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/06/358/001-021 14.4.2008 14.4.2008 Intrinsa Procter & Gamble Pharmaceuticals UK Ltd Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW United Kingdom EU/1/06/352/001-003 16.4.2008 14.4.2008 Livensa Procter & Gamble Pharmaceuticals — Germany GmbH Dr Otto-Röhm-Straße 2-4 D-64331 Weiterstadt EU/1/06/351/001-003 16.4.2008 14.4.2008 ViraferonPeg Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/00/132/001-050 16.4.2008 14.4.2008 PegIntron Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/00/131/001-050 16.4.2008 14.4.2008 Revasc Canyon Pharmaceuticals Ltd 20-22 Bedford Row London WC1R 4JS United Kingdom EU/1/97/043/001-003 16.4.2008 14.4.2008 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/069/008-010 16.4.2008 16.4.2008 Iscover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/98/070/008-010 18.4.2008 17.4.2008 Ebixa H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby EU/1/02/219/001-021 21.4.2008 17.4.2008 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/03/267/008-009 21.4.2008 18.4.2008 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/283/001-012 22.4.2008 18.4.2008 Zevalin Bayer Schering Pharma AG D-13342 Berlin EU/1/03/264/001 22.4.2008 18.4.2008 Nexavar Bayer HealthCare AG D-51368 Leverkusen EU/1/06/342/001 22.4.2008 18.4.2008 Levemir Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/04/278/004-006 22.4.2008 18.4.2008 Insulatard Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/233/013-015 22.4.2008 18.4.2008 Neupopeg Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/02/228/001-003 23.4.2008 18.4.2008 M-M-RVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/337/001-013 23.4.2008 18.4.2008 NovoMix Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/00/142/009-010 EU/1/00/142/014-016 EU/1/00/142/020-022 22.4.2008 21.4.2008 Stalevo Orion Corporation Orionintie 1 FI-02200 Espoo EU/1/03/260/019-023 23.4.2008 21.4.2008 Neulasta Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/02/227/001-003 23.4.2008 21.4.2008 Xeristar Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/04/297/001-008 23.4.2008 21.4.2008 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/296/001-009 23.4.2008 21.4.2008 Rapamune Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/01/171/001 EU/1/01/171/007-012 24.4.2008 21.4.2008 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/03/267/001-009 24.4.2008 21.4.2008 Velcade Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/04/274/001-002 23.4.2008 21.4.2008 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/251/001-002 23.4.2008 21.4.2008 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/03/247/001-002 23.4.2008 22.4.2008 Invega Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/07/395/001-064 24.4.2008 22.4.2008 Wilzin Orphan Europe S.àr.l. Gaulle F-92800 Puteaux EU/1/04/286/001-002 24.4.2008 22.4.2008 IntronA Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/99/127/001-044 24.4.2008 22.4.2008 Viraferon Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/99/128/001-037 24.4.2008 22.4.2008 Rilutek Aventis Pharma S.A. 20, avenue Raymond Aron F-92165 Antony Cedex EU/1/96/010/001 24.4.2008 22.4.2008 Intrinsa Procter & Gamble Pharmaceuticals UK Ltd Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW United Kingdom EU/1/06/352/001-003 24.4.2008 22.4.2008 Tritanrix HepB GlaxoSmithKline Biologicals s.a. rue de l'Institut, 89 B-1330 Rixensart EU/1/96/014/001-003 24.4.2008 22.4.2008 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 24.4.2008 22.4.2008 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 24.4.2008 23.4.2008 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 25.4.2008 23.4.2008 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 25.4.2008 23.4.2008 Emselex Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/04/294/001-028 25.4.2008 23.4.2008 MIRCERA Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/07/400/001-016 25.4.2008 23.4.2008 YENTREVE Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/280/001-008 25.4.2008 23.4.2008 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/99/125/001-016 25.4.2008 23.4.2008 Visudyne Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/00/140/001 25.4.2008 23.4.2008 Ferriprox Apotex Europe B.V. Darwingweg 20 2333 CR Leiden Nederland EU/1/99/108/001-003 25.4.2008 23.4.2008 NovoRapid Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/99/119/009-011 EU/1/99/119/015 25.4.2008 23.4.2008 Rotateq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/348/001-002 25.4.2008 25.4.2008 Cystagon Orphan Europe S.à.rl. Immeuble Le Wilson 70, Avenue du Général de Gaulle F-92800 Puteaux EU/1/97/039/001-004 29.4.2008 25.4.2008 NovoSeven Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/96/006/004-006 29.4.2008 25.4.2008 TESAVEL Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/435/001-018 29.4.2008 25.4.2008 Tysabri Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland EU/1/06/346/001 30.4.2008 25.4.2008 Protaphane Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/234/013-015 29.4.2008 25.4.2008 Livensa Procter & Gamble Pharmaceuticals — Germany GmbH Dr Otto-Röhm-Straße 2-4 D-64331 Weiterstadt EU/1/06/351/001-003 29.4.2008

— 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 10.4.2008 Previcox Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/04/045/001-007 15.4.2008 10.4.2008 Clomicalm Novartis Tiergesundheit GmbH Zielstattstraße 40 D-81379 München EU/2/98/007/001-003 14.4.2008 16.4.2008 Rabigen SAG2 VIRBAC S.A. 1ère Avenue 2065 m L.I.D. F-06516 Carros EU/2/00/021/001-002 21.4.2008 17.4.2008 Virbagen Omega VIRBAC S.A. 1ère Avenue 2065 m L.I.D. F-06516 Carros EU/2/01/030/001-004 21.4.2008 25.4.2008 ProteqFlu Te Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/03/038/005 29.4.2008 25.4.2008 ProteqFlu Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/03/037/005 29.4.2008

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.