EN Official Journal of the European Union C 152/8

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.5.2006 to 31.5.2006

(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 152/07)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — 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 5.5.2006 M-M-RVAXPRO Measles, Mumps and Rubella Vaccine (Live) Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/337/001-013 Powder and solvent for suspension for injection J07BD52 11.5.2006 19.5.2006 Zostavax Zoster vaccine (Live) Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/341/001-002 Powder and solvent for suspension for injection (Non applicable) 23.5.2006 EU/1/06/341/003-013 Powder and solvent for suspension for injection in a pre-filled syringe 19.5.2006 Ganfort bimatoprost/timolol Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo Ireland EU/1/06/340/001-002 Eye drops, solution S01ED 51 23.5.2006 29.5.2006 Evoltra clofarabine Bioenvision Limited Bassett House 5 Southwell Park Road Camberley Surrey, GU15 3PU United Kingdom EU/1/06/334/001-004 Concentrate for solution for infusion L01BB0680 31.5.2006

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — 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 19.5.2006 Zelnorm Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom — 24.5.2006

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — 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 2.5.2006 Agenerase Glaxo Group Ltd, Greenford Middlesex UB6 0NN United Kingdom EU/1/00/148/001-004 4.5.2006 2.5.2006 Ventavis Schering AG Müllerstraße 170-178 D-13342 Berlin EU/1/03/255/001-005 4.5.2006 5.5.2006 Vivanza Bayer AG D-51368 Leverkusen EU/1/03/249/001-012 11.5.2006 5.5.2006 AVANDIA SmithKline Beecham plc 980 Great West Road Brentford Middlesex, TW8 9GS United Kingdom EU/1/00/137/001-018 11.5.2006 5.5.2006 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/134/001-029 11.5.2006 5.5.2006 Dynastat Pfizer Ltd, Ramsgate Road Sandwich, Kent CT 13 9NJ United Kingdom Pharmacia Europe EEIG Sandwich Kent, CT13 9NJ United Kingdom EU/1/02/209/001-008 11.5.2006 5.5.2006 Insuman Aventis Pharma Deutschland GmbH Brueningstraße 50 D-65926 Frankfurt am Main EU/1/97/030/065-084 11.5.2006 5.5.2006 Apidra Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/04/285/013-020 11.5.2006 5.5.2006 Levitra Bayer AG D-51368 Leverkusen EU/1/03/248/001-012 11.5.2006 10.5.2006 GONAL-f Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/95/001/001 EU/1/95/001/003-005 EU/1/95/001/009 EU/1/95/001/012 EU/1/95/001/021-022 EU/1/95/001/035 12.5.2006 10.5.2006 Forcaltonin Unigene UK Limited 191 Sparrows Herne Bushey Heath Hertfordshire WD23 1AJ United Kingdom EU/1/98/093/002 16.5.2006 16.5.2006 Lyrica PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/04/279/033-035 17.5.2006 19.5.2006 Caelyx Schering Plough Europe Rue de Stalle, 73/Stallestraat 73 B-1180 Bruxelles/Brussel EU/1/96/011/001-004 23.5.2006 19.5.2006 Osigraft Howmedica International S. de R.L. Division of Stryker Corporation Raheen Industrial Estate Raheen, Limerick Ireland EU/1/01/179/001 24.5.2006 19.5.2006 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham, Basingstoke Hampshire RG24 8EP United Kingdom EU/1/04/295/001 23.5.2006 19.5.2006 Nespo Dompé Biotec S.p.A. Via San Martino 12 I-20122 Milano EU/1/01/184/001-056 23.5.2006 19.5.2006 Aranesp Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/01/185/001-056 23.5.2006 19.5.2006 IntronA Schering Plough Europe Rue de Stalle, 73/Stallestraat 73 B-1180 Bruxelles/Brussel EU/1/99/127/001-039 23.5.2006 19.5.2006 PegIntron Schering Plough Europe Rue de Stalle, 73/Stallestraat 73 B-1180 Bruxelles/Brussel EU/1/00/131/001-050 23.5.2006 19.5.2006 Viraferon Schering Plough Europe Rue de Stalle, 73/Stallestraat 73 B-1180 Bruxelles/Brussel EU/1/99/128/001-037 23.5.2006 19.5.2006 ViraferonPeg Schering Plough Europe Rue de Stalle, 73/Stallestraat 73 B-1180 Bruxelles/Brussel EU/1/00/132/001-046 23.5.2006 22.5.2006 Prandin Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/00/162/019-021 24.5.2006 22.5.2006 Herceptin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/00/145/001 24.5.2006 29.5.2006 NovoNorm Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/98/076/022-024 31.5.2006 29.5.2006 Puregon Organon N.V P.O. Box 20 5340 BH Oss Nederland EU/1/96/008/001-041 31.5.2006 29.5.2006 PEGASYS Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/221/001-010 31.5.2006 29.5.2006 Emend Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/03/262/001-008 31.5.2006 29.5.2006 Emend Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/03/262/007-008 31.5.2006 31.5.2006 Xeristar Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/04/297/001-008 2.6.2006 31.5.2006 Viramune Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/055/001-003 2.6.2006 31.5.2006 Aldurazyme Genzyme Europe B.V Gooimeer 10 1411 DD Naarden Nederland EU/1/03/253/001-003 2.6.2006 31.5.2006 Kineret Amgen Europe B.V Minervum 7061 4817 ZK Breda Nederland EU/1/02/203/001-004 2.6.2006 31.5.2006 Prialt Elan Pharma International Ltd WIL House Shannon Business Park Shannon County Clare Ireland EU/1/04/302/001-004 2.6.2006 31.5.2006 Trudexa Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/257/001-006 2.6.2006 31.5.2006 Ariclaim Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/04/283/001-007 2.6.2006 31.5.2006 Xenical Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom EU/1/98/071/001-006 2.6.2006 31.5.2006 AVANDIA SmithKline Beecham plc 980 Great West Road Brentford Middlesex, TW8 9GS United Kingdom EU/1/00/137/002-018 2.6.2006 31.5.2006 Rebif Serono Europe Ltd. 56, Marsh Wall London E14 9TP United Kingdom EU/1/98/063/001-007 2.6.2006 31.5.2006 YENTREVE Eli Lilly Nederland B.V Grootslag 1-5 3991 RA Houten Nederland EU/1/04/280/001-007 2.6.2006 31.5.2006 Enbrel Abbott Laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom EU/1/06/350/001-011 2.6.2006 31.5.2006 Abilify Otsuka Pharmaceutical Europe Ltd Commonwealth House 2 Chalkhill Road Hammersmith London W6 8DW United Kingdom EU/1/04/276/001-035 2.6.2006 31.5.2006 Vfend Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom EU/1/02/212/001-026 2.6.2006 31.5.2006 Rapamune Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH United Kingdom EU/1/01/171/007-010 2.6.2006 31.5.2006 Xeloda Roche Registration Limited 40 Broadwater Road Welwyn Garden City Hertfordshire AL7 3AY United Kingdom EU/1/00/163/001-002 2.6.2006 31.5.2006 Aprovel -77 Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France F-75013 Paris EU/1/97/046/001-033 2.6.2006 31.5.2006 Cymbalta Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/04/296/001-008 2.6.2006

— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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 5.5.2006 Infergen Astellas Pharma Europe B.V Elisabethhof 19 2353 EW Leiderdorp Nederland EU/1/98/087/001-003 11.5.2006

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — 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 22.5.2006 Aivlosin W 04-W 05 ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/001-005 24.5.2006

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.