EN Official Journal of the European Union C 288/1

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2009 to 31 October 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 288/01

— 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 1.10.2009 Onglyza Saxagliptin Bristol Myers Squibb/AstraZeneca EEIG, Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/09/545/001-010 Film-coated tablet A10BH03 5.10.2009 1.10.2009 Cimzia certolizumab pegol UCB Pharma SA., Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/09/544/001-002 Solution for injection L04AB05 6.10.2009 1.10.2009 Simponi golimumab Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/09/546/001-004 Solution for injection in pre-filled pen L04AB06 6.10.2009 5.10.2009 ChondroCelect Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins TiGenix NV, Romeinse straat 12/2, B-3001 Leuven, België EU/1/09/563/001 Implantation suspension Non applicable 7.10.2009 14.10.2009 Enyglid Repaglinide KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/580/001-018 Tablet A10B X02 16.10.2009 15.10.2009 Resolor prucalopride Movetis NV, Veedijk 58, B-2300 Turnhout, België EU/1/09/581/001-002 Film-coated tablets A03AE04 19.10.2009 15.10.2009 Imprida HCT amlodipine besylate / valsartan / hydrochlorothiazide Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/570/001-060 Film-coated tablet C09DX01 19.10.2009 16.10.2009 Clopidogrel MYLAN Pharma Clopidogrel Mylan S.A.S, 117 allee des Parcs, 69800 Saint Priest, France EU/1/09/568/001-018 Film-coated tablet B01AC-04 20.10.2009 16.10.2009 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated) Baxter AG, Industriestraße 67, A - 1221 Wien, Österreich EU/1/09/571/001 Suspension for injection J07BB01 20.10.2009 16.10.2009 Exforge HCT amlodipine besylate / valsartan / hydrochlorothiazide Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/569/001-060 Film-coated tablet C09DX01 20.10.2009 16.10.2009 ALENDRONATE SODIUM AND COLECALCIFEROL, MSD alendronic acid / colecalciferol Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572/001-009 Tablet M05BB03 20.10.2009 19.10.2009 Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14 GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/578/001 Suspension and Emulsion for emulsion for injection J07BB02 21.10.2009 19.10.2009 Foclivia A/Viet Nam/1194/2004 (H5N1) virus surface inactivated antigen Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina, 1 - Siena, Italia EU/1/09/577/001-004 Suspension for injection J07BB02 21.10.2009 23.10.2009 Lamivudine Teva Lamivudine Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/566/001-005 Film-coated tablet J05AF05 27.10.2009 23.10.2009 Biopoin epoetin theta CT Arzneimittel GmbH, Lengeder Straße 42a, D-13407 Berlin, Deutschland EU/1/09/565/001-028 Solution for injection B03XA01 27.10.2009 23.10.2009 ARCALYST Rilonacept Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom EU/1/09/582/001 Powder and solvent for solution for injection L04AC04 27.10.2009 23.10.2009 ILARIS Canakinumab Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564/001-002 Powder for solution for injection L04AC08 27.10.2009 29.10.2009 Eporatio epoetin theta ratiopharm GmbH, Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/573/001-028 Solution for injection B03XA01 2.11.2009 30.10.2009 Irbesartan Teva Irbesartan Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/576/001-039 Film-coated tablet C09C A04 4.11.2009

— 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 1.10.2009 Epoetin alfa Hexal Hexal AG., Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/07/411/021-026 5.10.2009 1.10.2009 Mixtard Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/231/001-037 5.10.2009 1.10.2009 Protaphane Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/234/001-017 5.10.2009 1.10.2009 Insulatard Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/233/001-017 5.10.2009 1.10.2009 Actrapid Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/230/001-017 5.10.2009 1.10.2009 Actraphane Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/229/001-037 6.10.2009 1.10.2009 Binocrit Sandoz GmbH, Biochemiestrasse 10, Kundl 6250, Österreich EU/1/07/410/021-026 5.10.2009 2.10.2009 Tasmar Meda AB, Pipers väg 2A, Solna 170 09, Sverige EU/1/97/044/001-008 6.10.2009 6.10.2009 CELVAPAN Baxter AG, Industriestraße 67, 1221 Wien, Österreich EU/1/08/506/001 8.10.2009 7.10.2009 Agenerase Glaxo Group Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/00/148/001-004 9.10.2009 7.10.2009 IntronA Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/99/127/031-039 9.10.2009 8.10.2009 Mirapexin Boehringer Ingelheim International GmbH, Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/97/051/013-027 12.10.2009 8.10.2009 Sifrol Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/050/013-027 12.10.2009 8.10.2009 Nplate Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland EU/1/08/497/001-004 12.10.2009 8.10.2009 Circadin RAD Neurim Pharmaceuticals EEC Limited, One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom EU/1/07/392/001-002 12.10.2009 13.10.2009 NovoMix Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/00/142/004-005 EU/1/00/142/009-022 15.10.2009 13.10.2009 Olanzapine Neopharma Neopharma Limited, 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom EU/1/07/426/001-011 15.10.2009 13.10.2009 CellCept Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/005/001-006 15.10.2009 13.10.2009 Kinzalkomb Bayer Schering Pharma AG, D-13342 Berlin, Deutschland EU/1/02/214/001-015 15.10.2009 14.10.2009 alli Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/401/001-006 16.10.2009 14.10.2009 Onsenal Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/03/259/001-006 16.10.2009 14.10.2009 PritorPlus Bayer Schering Pharma AG, 13342 Berlin, Deutschland EU/1/02/215/001-021 16.10.2009 14.10.2009 Ammonaps Swedish Orphan International AB, Drottninggatan 98, 111 60 Stockholm, Sverige EU/1/99/120/001-004 19.10.2009 15.10.2009 Nexavar Bayer Schering Pharma AG, 13342 Berlin, Deutschland EU/1/06/342/001 19.10.2009 16.10.2009 Helixate NexGen Bayer Schering Pharma AG, 13342 Berlin, Deutschland EU/1/00/144/001-004 20.10.2009 16.10.2009 Aptivus Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland EU/1/05/315/001-002 20.10.2009 16.10.2009 KOGENATE Bayer Bayer Schering Pharma AG, 13342 Berlin, Deutschland EU/1/00/143/001-011 20.10.2009 19.10.2009 Thalidomide Celgene Celgene Europe Limited, Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom EU/1/08/443/001 21.10.2009 19.10.2009 Ribavirin Teva Pharma BV Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/527/001-016 21.10.2009 19.10.2009 Revlimid Celgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom EU/1/07/391/001-004 21.10.2009 19.10.2009 Prepandrix GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, Rixensart, 1330 Belgique EU/1/08/453/002 21.10.2009 19.10.2009 Wilzin Orphan Europe S.a.r.l., Immeuble Le Wilson, 70 Avenue du Général de Gaulle, 92800 Puteaux, France EU/1/04/286/001-002 21.10.2009 19.10.2009 Olanzapine Teva Teva Pharma B.V., Computerweg 10, DR Utrecht 3542,Nederland EU/1/07/427/001-057 21.10.2009 20.10.2009 Vidaza Celgene Europe Ltd, Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom EU/1/08/488/001 22.10.2009 21.10.2009 Xarelto Bayer Schering Pharma AG, 13342 Berlin, Deutschland EU/1/08/472/001-008 23.10.2009 21.10.2009 Metalyse Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland EU/1/00/169/004-006 23.10.2009 21.10.2009 Filgrastim Hexal HEXAL AG, Industriestrasse 25, 83607 Holzkirchen, Deutschland EU/1/08/496/001-008 26.10.2009 21.10.2009 Zarzio Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/08/495/001-008 23.10.2009 23.10.2009 Rebif Merck Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063/001-010 27.10.2009 23.10.2009 Prezista Janssen-Cilag International NV, Turnhoutseweg, 30 - 2340 Beerse – België EU/1/06/380/001-005 27.10.2009 23.10.2009 Olanzapine Mylan Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/08/475/001-034 27.10.2009 23.10.2009 Norvir Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/96/016/001 EU/1/96/016/003-004 27.10.2009 23.10.2009 PEGASYS Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221/001-010 27.10.2009 23.10.2009 Invanz Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/02/216/001-002 27.10.2009 23.10.2009 Procoralan Les Laboratoires Servier, 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/05/316/001-014 27.10.2009 23.10.2009 Teslascan GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 Oslo, Norway EU/1/97/040/001-002 27.10.2009 23.10.2009 Vistide Gilead Sciences International Limited, Cambridge, CB21 6GT, United Kingdom EU/1/97/037/001 27.10.2009 23.10.2009 RotaTeq Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, Lyon 69007, France EU/1/06/348/001-002 27.10.2009 23.10.2009 Tamiflu Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-004 27.10.2009 23.10.2009 Corlentor Les Laboratoires Servier, 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/05/317/001-014 27.10.2009 23.10.2009 Neulasta Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland EU/1/02/227/001-004 27.10.2009 23.10.2009 Ellaone Laboratoire HRA Pharma, 15, rue Béranger, 75003 Paris, France EU/1/09/522/001 27.10.2009 28.10.2009 Xelevia Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382/001-018 30.10.2009 28.10.2009 TESAVEL Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435/001-018 30.10.2009 28.10.2009 Pradaxa Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-008 2.11.2009 28.10.2009 Aranesp Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland EU/1/01/185/001-022 EU/1/01/185/031-099 30.10.2009 28.10.2009 Zerit Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/96/009/001-009 30.10.2009 28.10.2009 Arava Sanofi-Aventis Deutschland GmbH, 65926 Frankfurt am Main, Deutschland EU/1/99/118/001-010 30.10.2009 28.10.2009 Yondelis Pharma Mar, S.A., Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), España EU/1/07/417/001-002 30.10.2009 28.10.2009 Myozyme Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, Nederland EU/1/06/333/001-003 2.11.2009 28.10.2009 SUTENT Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/347/001-008 30.10.2009 28.10.2009 Integrilin Glaxo Group Ltd, Greenford, Middlesex, UB6 ONN, United Kingdom EU/1/99/109/001-002 30.10.2009 28.10.2009 BeneFIX Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/97/047/001-007 30.10.2009 28.10.2009 RoActemra Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492/001-006 30.10.2009 28.10.2009 Beromun Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland EU/1/99/097/001 2.11.2009 28.10.2009 Epivir Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/96/015/001-005 30.10.2009 28.10.2009 IXIARO Intercell AG, Campus Vienna Biocenter 3 A-1030 Wien, Österreich EU/1/08/501/001-002 30.10.2009 28.10.2009 Efficib Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457/001-016 30.10.2009 28.10.2009 Janumet Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455/001-016 30.10.2009 28.10.2009 Noxafil SP Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/05/320/001 30.10.2009 28.10.2009 Velcade Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 30.10.2009 28.10.2009 Zostavax Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/341/001-013 30.10.2009 28.10.2009 Velmetia Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456/001-016 30.10.2009 29.10.2009 Sebivo Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/388/001-003 2.11.2009 29.10.2009 ADROVANCE Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/364/001-009 2.11.2009 29.10.2009 Remicade Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 2.11.2009 29.10.2009 INOmax INO Therapeutics AB, SE-181 81 Lidingö, Sverige EU/1/01/194/001-002 3.11.2009 30.10.2009 Xagrid Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295/001 4.11.2009 30.10.2009 Zalasta KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/07/415/001-056 4.11.2009 30.10.2009 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Deutschland EU/1/06/368/001-168 4.11.2009

— Lift of 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 8.10.2009 Optison GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 Oslo, Norway EU/1/98/065/001-002 12.10.2009

— 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 1.10.2009 Oxyglobin Biopure Netherlands B.V., Parnassustoren, Locatellikade 1, 1076 AZ Amsterdam, Nederland EU/2/99/015/001-002 5.10.2009 1.10.2009 Stronghold Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/99/014/001-012 5.10.2009 6.10.2009 Nobilis Influenza H5N2 Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/06/061/001-004 8.10.2009 8.10.2009 Naxcel Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/05/053/003 12.10.2009 8.10.2009 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited, Loughrea, Co. Galway, IRELAND EU/2/07/078/005-008 12.10.2009 8.10.2009 Meloxidyl CEVA SANTE ANIMALE, Z.I. la Ballastière, 33500 Libourne, France EU/2/06/070/004 12.10.2009 21.10.2009 Suprelorin VIRBAC S.A., 1ère Avenue 2065 m L.I.D. - 06516 Carros – France EU/2/07/072/001-002 23.10.2009 30.10.2009 Easotic VIRBAC S.A., 1ère Avenue 2065 m L.I.D. - 06516 Carros – France EU/2/08/085/001 4.11.2009

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 of 30.4.2004, p. 1.