EN Official Journal of the European Union C 24/8

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

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

(2009/C 24/06)

— 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 1.12.2008 Irbesartan Krka Irbesartan KRKA d.d. Šmarješka cesta 6 SLO-8501 Novo mesto EU/1/08/480/001-018 Film-coated tablet C09CA04 3.12.2008 1.12.2008 Vildagliptin/metformin hydrochloride Novartis Vildagliptin/metformin hydrochloride Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/08/484/001-018 Film-coated tablet A10BD08 3.12.2008 1.12.2008 Zomarist Vildagliptin/metformin hydrochloride Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/08/483/001-018 Film-coated tablet A10BD08 3.12.2008 2.12.2008 Kuvan Sapropterin dihydrochloride Merck KgaA Frankfurter Straße 250 D-64293 Darmstadt EU/1/08/481/001-003 Soluble tablet A16AX07 4.12.2008 17.12.2008 Vidaza Azacitidine Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA United Kingdom EU/1/08/488/001 Powder for suspension for injection L01BC07 22.12.2008 18.12.2008 Pramipexole Teva Pramipexole Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland EU/1/08/490/001-016 Tablet N04B C05 23.12.2008

— 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 1.12.2008 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/99/110/001-009 3.12.2008 2.12.2008 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main EU/1/02/218/001-029 4.12.2008 2.12.2008 Ebixa H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby EU/1/02/219/001-049 4.12.2008 2.12.2008 Herceptin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/00/145/001 4.12.2008 2.12.2008 Rebetol Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/99/107/001-005 4.12.2008 4.12.2008 Xigris Eli Lilly Nederland B.V., Grootslag 1-5 3991 RA Houten Nederland EU/1/02/225/001-002 9.12.2008 4.12.2008 Visudyne Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/00/140/001 9.12.2008 4.12.2008 Noxafil SP Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/05/320/001 9.12.2008 4.12.2008 Ammonaps Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm EU/1/99/120/001-004 10.12.2008 5.12.2008 Optimark Covidien Deutschland GmbH Gewerbepark 1 D-93333 Neustadt/Donau EU/1/07/398/001-014 9.12.2008 5.12.2008 ViraferonPeg Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/00/132/001-050 9.12.2008 5.12.2008 Norvir Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/96/016/001 EU/1/96/016/003-004 9.12.2008 5.12.2008 PegIntron Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/00/131/001-050 9.12.2008 5.12.2008 MabCampath Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/01/193/001-002 9.12.2008 12.12.2008 Mixtard Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/231/033-035 16.12.2008 16.12.2008 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/001 18.12.2008 16.12.2008 Faslodex AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom EU/1/03/269/001 18.12.2008 16.12.2008 Somavert Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/02/240/001-004 18.12.2008 17.12.2008 Temodal Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/98/096/001-012 22.12.2008 17.12.2008 Fareston Orion Corporation Orionintie 1 FIN-02200 Espoo EU/1/96/004/001-002 22.12.2008 17.12.2008 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 22.12.2008 17.12.2008 Actrapid Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/230/013-015 22.12.2008 17.12.2008 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 22.12.2008 17.12.2008 Avandia SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/00/137/002-018 22.12.2008 17.12.2008 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/251/001-002 22.12.2008 17.12.2008 Exjade Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/356/001-009 22.12.2008 17.12.2008 Avonex Biogen Idec Ltd Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom EU/1/97/033/002-004 22.12.2008 17.12.2008 Actraphane Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/229/033-035 22.12.2008 19.12.2008 Tysabri Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland EU/1/06/346/001 23.12.2008 22.12.2008 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 24.12.2008 22.12.2008 Arixtra Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/206/001-020 24.12.2008 22.12.2008 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/04/279/001-043 24.12.2008 22.12.2008 Cholestagel Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/03/268/001-004 24.12.2008 22.12.2008 Vectibix Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/07/423/001-003 24.12.2008 22.12.2008 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/001 24.12.2008 22.12.2008 Invanz Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/02/216/001-002 24.12.2008 22.12.2008 Cerezyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/97/053/001-005 24.12.2008 22.12.2008 Atripla Bristol-Myers Squibb and Gilead Sciences Limited Unit 13 Stillorgan Industrial Park Blackrock Co. Dublin Ireland EU/1/07/430/001-002 5.1.2009 22.12.2008 Revlimid Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA United Kingdom EU/1/07/391/001-004 24.12.2008 22.12.2008 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/001-018 24.12.2008 22.12.2008 Truvada Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/04/305/001-002 24.12.2008 22.12.2008 Evra Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/02/223/001-003 24.12.2008 22.12.2008 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 29.12.2008

— Modification 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 8.12.2008 Xeristar Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/04/297/001-008 10.12.2008 8.12.2008 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/296/001-009 10.12.2008

— 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 5.12.2008 Parareg Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/04/293/001-012 9.12.2008 5.12.2008 Neupopeg Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/02/228/001-003 9.12.2008 5.12.2008 Nespo Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/01/184/001-073 9.12.2008

— 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 9.12.2008 Acticam Meloxicam Omnipharm Ltd The Spire Egypt Road Nottingham NG7 7GD United Kingdom EU/2/08/088/001-003 Oral suspension QM01AC06 11.12.2008 EU/2/08/088/004 Solution for injection 16.12.2008 Onsior Robenacoxib Novartis Animal Health UK Ltd Frimley Business Park Frimley/Camberley Surrey GU16 7SR United Kingdom EU/2/08/089/001-019 Tablet QM01AH91 18.12.2008 EU/2/08/089/020 Solution for injection

— 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 5.12.2008 Locatim Biokema Anstalt Aeulestraße 38 FL-9490 Vaduz, Fürstentum Liechtenstein EU/2/99/011/001 10.12.2008 9.12.2008 Flexicam Omnipharm Ltd The Spire Egypt Road Nottingham NG7 7GD United Kingdom EU/2/06/058/004 11.12.2008 16.12.2008 Equilis StrepE Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/04/043/001 18.12.2008

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.