EN Official Journal of the European Union C 48/4

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 2009

(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 48/04)

— 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 16.1.2009 RoActemra Tocilizumab Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/08/492/001-006 Concentrate for solution for infusion L04AC07 20.1.2009 16.1.2009 Rasilez HCT Aliskiren hemifumarate/hydrochlorothiazide Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/08/491/001-080 Film-coated tablet C09XA52 20.1.2009 16.1.2009 STELARA Ustekinumab Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/08/494/001-002 Solution for injection L04AC05 20.1.2009

— 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 5.1.2009 Tasigna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/422/001-004 8.1.2009 5.1.2009 Irbesartan HCT BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/06/369/011-028 7.1.2009 6.1.2009 ECALTA Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/07/416/001 8.1.2009 6.1.2009 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-La-Neuve EU/1/00/167/001-008 8.1.2009 6.1.2009 Alimta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/290/001-002 8.1.2009 7.1.2009 Humalog Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010-011 EU/1/96/007/015-021 EU/1/96/007/023-030 EU/1/96/007/037-038 9.1.2009 7.1.2009 Irbesartan HCT Winthrop Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/06/377/011-028 9.1.2009 7.1.2009 Levemir Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/04/278/001-009 9.1.2009 7.1.2009 Zevalin Bayer Schering Pharma AG D-13342 Berlin EU/1/03/264/001 12.1.2009 7.1.2009 ISENTRESS Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/436/001-002 9.1.2009 7.1.2009 TORISEL Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/07/424/001 9.1.2009 7.1.2009 Retacrit HOSPIRA Enterprises B.V. Taurusavenue 19-21b 2132 LS Hoofddorp Nederland EU/1/07/431/001-025 12.1.2009 7.1.2009 BYETTA Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/06/362/001-004 9.1.2009 7.1.2009 Xolair Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/05/319/001-004 9.1.2009 9.1.2009 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/06/363/010-011 13.1.2009 9.1.2009 IntronA Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/99/127/001-044 13.1.2009 9.1.2009 Rilutek Aventis Pharma S.A. 20, avenue Raymond Aron F-92160 Antony EU/1/96/010/001 13.1.2009 9.1.2009 Xyrem UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE United Kingdom EU/1/05/312/001 13.1.2009 12.1.2009 Invega Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/07/395/077-095 14.1.2009 12.1.2009 Invega Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/07/395/001-095 14.1.2009 13.1.2009 Emadine Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/98/095/001-004 15.1.2009 15.1.2009 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/06/363/001-011 20.1.2009 16.1.2009 Cyanokit Merck Santé s.a.s. 37, rue Saint-Romain F-69379 Lyon Cedex 08 EU/1/07/420/001 21.1.2009 16.1.2009 Rebif Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/98/063/008-010 20.1.2009 16.1.2009 Regranex Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/99/101/001 20.1.2009 20.1.2009 Alli Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/07/401/007-010 22.1.2009 20.1.2009 Sebivo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/388/003 22.1.2009 22.1.2009 Temodal Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/98/096/001-022 27.1.2009 23.1.2009 Tysabri Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland EU/1/06/346/001 27.1.2009 26.1.2009 Synagis Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/99/117/001-002 28.1.2009 26.1.2009 Keppra UCB Pharma S.A. Allée de la Recherche 60/Researchdreef, 60 B-1070 Bruxelles/Brussel EU/1/00/146/001-030 28.1.2009 26.1.2009 Zostavax Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/341/001-013 28.1.2009 26.1.2009 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/069/001a EU/1/98/069/002a EU/1/98/069/003a EU/1/98/069/004a EU/1/98/069/005a EU/1/98/069/006a EU/1/98/069/007a EU/1/98/069/011a EU/1/98/069/011b 28.1.2009 26.1.2009 Volibris Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/08/451/001-004 28.1.2009 26.1.2009 Fasturtec Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/00/170/001-002 28.1.2009 26.1.2009 Prometax Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/092/001-018 28.1.2009 26.1.2009 Zavesca Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/238/001 28.1.2009 26.1.2009 Mirapexin Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/051/001-006 EU/1/97/051/009-012 28.1.2009 26.1.2009 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/222/001-004 28.1.2009 27.1.2009 Tritanrix HepB GlaxoSmithKline Biologicals S.A. rue de l'Institut, 89 B-1330 Rixensart EU/1/96/014/001-003 29.1.2009 27.1.2009 Thelin Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom EU/1/06/353/001-005 29.1.2009 27.1.2009 PritorPlus Bayer HealthCare AG D-51368 Leverkusen EU/1/02/215/001-021 29.1.2009 27.1.2009 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/251/001-002 29.1.2009 27.1.2009 Viramune Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/055/001-003 29.1.2009 27.1.2009 MicardisPlus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/02/213/001-023 29.1.2009 27.1.2009 Iscover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/98/070/001a EU/1/98/070/002a EU/1/98/070/003a EU/1/98/070/004a EU/1/98/070/005a EU/1/98/070/006a EU/1/98/070/007a EU/1/98/070/011a EU/1/98/070/011b 29.1.2009 27.1.2009 Tarceva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/05/311/001-003 29.1.2009 27.1.2009 Invirase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/026/001-002 29.1.2009 28.1.2009 Diacomit Biocodex 7, avenue Gallieni F-94250 Gentilly EU/1/06/367/001-012 30.1.2009 29.1.2009 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/002-003 2.2.2009 29.1.2009 Aloxi Helsinn Birex Pharmaceuticals Ltd Damastown Mulhuddart Dublin 15 Republic of Ireland EU/1/04/306/001 2.2.2009 29.1.2009 Kinzalkomb Bayer HealthCare AG D-51368 Leverkusen EU/1/02/214/001-015 2.2.2009 29.1.2009 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/06/363/001-011 2.2.2009 30.1.2009 Exelon Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/066/001-018 4.2.2009 30.1.2009 NeuroBloc Eisai Limited 3, Shortlands London W6 8EE United Kingdom EU/1/00/166/001-003 3.2.2009 30.1.2009 Sifrol Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/050/001-006 EU/1/97/050/009-012 4.2.2009 30.1.2009 Thalidomide Celgene Celgene Europe Limited Riverside House Riverside Walk Windsor SL4 1NA United Kingdom EU/1/08/443/001 3.2.2009

— 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 16.1.2009 Zimulti Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/345/001-011 20.1.2009 16.1.2009 ACOMPLIA Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/344/001-011 20.1.2009 30.1.2009 Velosulin Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/232/001-003 3.2.2009

— Suspension of a marketing authorization (Article 20 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 16.1.2009 Ionsys Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse EU/1/05/326/001 20.1.2009

— 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 12.1.2009 Porcilis PCV Porcine circovirus type 2 ORF2 subunit antigen Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/08/091/001-010 Emulsion for injection QI09AA07 14.1.2009

— 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 13.1.2009 Novem Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein EU/2/04/042/001-004 16.1.2009 20.1.2009 Fevaxyn Pentofel Fort Dodge Laboratories Ireland Finisklin Industrial Estate — Sligo Ireland EU/2/96/002/001-003 22.1.2009

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.