EN Official Journal of the European Union C 56/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011

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

2012/C 56/01

— 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 3.11.2011 Plenadren hydrocortisone DuoCort Pharma AB Kullagatan 8-10, S-252 20 Helsingborg, Sveridge EU/1/11/715/001-002 Modified-release tablet H02AB09 14.11.2011 16.11.2011 IOA nomegestrol / estradiol N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/11/689/001-002 Film-coated tablet G03AA14 18.11.2011 16.11.2011 Vyndaqel tafamidis Pfizer Specialty UK Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/11/717/001 Capsule, soft N07XX08 18.11.2011 22.11.2011 Rasitrio aliskiren / amlodipine / hydrochlorothiazide Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/730/001-060 Film-coated tablet C09XA54 24.11.2011 24.11.2011 Desloratadine Teva desloratadine Teva Pharma B.V Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/732/001-013 Film-coated tablet R06AX27 29.11.2011 24.11.2011 Komboglyze saxagliptin / metformin Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/731/001-012 Film-coated tablet A10BD 28.11.2011 24.11.2011 Onduarp telmisartan / amlodipine Boehringer Ingelheim International GmbH Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/11/729/001-006 Tablet C09DB04 28.11.2011 28.11.2011 Dasselta desloratadine KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/739/001-008 Film-coated tablet R06AX27 30.11.2011 28.11.2011 EDURANT rilpivirine Janssen Cilag International NV Turnhoutseweg 30, B 2340 Beerse, België EU/1/11/736/001 Film-coated tablet J05AG05 30.11.2011 28.11.2011 Eviplera emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate) Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom EU/1/11/737/001-002 Film-coated tablet J05AR08 28.11.2011 5.12.2011 Dificlir fidaxomicin FGK Representative Service GmbH Heimeranstrasse 35, 80339 München, Deutschland EU/1/11/733/001-004 Film-coated tablet Pending 7.12.2011 5.12.2011 Levetiracetam Actavis Group levetiracetam Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland EU/1/11/738/001-003 Oral solution N03AX14 7.12.2011 7.12.2011 Edarbi azilsartan medoxomil Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/11/734/001-011 Tablet C09CA09 9.12.2011 7.12.2011 Ipreziv azilsartan medoxomil Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/11/735/001-011 Tablet C09CA09 9.12.2011 14.12.2011 Ameluz 5-Aminolaevulinic acid Biofrontera Bioscience GmbH Hemmelrather Weg 201, 51377 Leverkusen, Deutschland EU/1/11/740/001 Gel L01XD04 19.12.2011 14.12.2011 Levetiracetam SUN levetiracetam Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/11/741/001 Concentrate for solution for infusion N03AX14 19.12.2011 22.12.2011 Repaglinide Accord Repaglinide Accord Healthcare Limited Sage house, 319 Pinner road, Harrow, HA1 4HF United Kingdom EU/1/11/743/001-015 Tablet A10BX02 28.12.2011 22.12.2011 Topotecan Eagle topotecan Eagle Laboratories Limited The Clock House, Station Approach, Marlow, Bucks SL7 1NT, UNITED KINGDOM EU/1/11/744/001-002 Concentrate for solution for infusion L01XX17 29.12.2011





— 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 3.11.2011 Clopidogrel Krka KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/556/001-011 7.11.2011 3.11.2011 Clopidogrel TAD TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland EU/1/09/555/001-009 7.11.2011 3.11.2011 Ozurdex Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland EU/1/10/638/001 7.11.2011 3.11.2011 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique EU/1/08/452/001 7.11.2011 3.11.2011 Protaphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/234/010-012 7.11.2011 3.11.2011 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-004 7.11.2011 10.11.2011 Actraphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/229/030-032 15.11.2011 10.11.2011 Actrapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/230/010-012 15.11.2011 10.11.2011 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118/001-010 15.11.2011 10.11.2011 Avamys Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/434/001-003 15.11.2011 10.11.2011 Clopidogrel Mylan Mylan S.A.S 117 allée des Parcs, 69 800 Saint Priest, France EU/1/09/559/001-016 15.11.2011 10.11.2011 Clopidogrel Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/540/001-016 15.11.2011 10.11.2011 Clopidogrel Zentiva Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/08/465/001-020 15.11.2011 10.11.2011 Conbriza Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/511/001-005 15.11.2011 10.11.2011 Cyanokit Merck Santé s.a.s. 37, rue Saint-Romain, 69379 Lyon Cedex 08, France EU/1/07/420/001-002 15.11.2011 10.11.2011 ellaOne Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France EU/1/09/522/001 15.11.2011 10.11.2011 Helixate NexGen Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/00/144/001-005 15.11.2011 10.11.2011 Javlor Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France EU/1/09/550/001-012 15.11.2011 10.11.2011 Kogenate Bayer Bayer Pharma AG 13342 Berlin, Deutschland EU/1/00/143/004-013 15.11.2011 10.11.2011 Levitra Bayer Pharma AG Berlin 13342, Deutschland EU/1/03/248/001-023 15.11.2011 10.11.2011 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358/001-008 EU/1/06/358/018-021 15.11.2011 10.11.2011 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423/001-003 15.11.2011 10.11.2011 Vfend Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/212/025 15.11.2011 10.11.2011 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529/001-005 15.11.2011 10.11.2011 Zebinix BIAL - Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal EU/1/09/514/001-020 15.11.2011 10.11.2011 Zevalin Bayer Pharma AG 13342 Berlin, Deutschland EU/1/03/264/001 15.11.2011 10.11.2011 Zoely Merck Serono Europe Limited 56 Marsh Wall, London E14 9TP, United Kingdom EU/1/11/690/001-002 15.11.2011 10.11.2011 Zomarist Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/483/001-018 15.11.2011 10.11.2011 Zylagren KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/558/001-010 16.11.2011 16.11.2011 Exelon Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/066/013 EU/1/98/066/018 18.11.2011 16.11.2011 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/357/001-008 EU/1/06/357/018-021 18.11.2011 16.11.2011 Vivanza Bayer Pharma AG Berlin 13342, Deutschland EU/1/03/249/001-015 18.11.2011 21.11.2011 Adrovance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/364/001-004 EU/1/06/364/006-008 23.11.2011 21.11.2011 Aldurazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/253/001-003 23.11.2011 21.11.2011 Celsentri ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/418/001-010 23.11.2011 21.11.2011 Champix Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/360/001-013 23.11.2011 21.11.2011 Copalia Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/372/001-039 22.11.2011 21.11.2011 Dafiro Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/371/001-039 22.11.2011 21.11.2011 Evoltra Genzyme Europe BV Gooimeer 10, 1411 DD Naarden, Nederland EU/1/06/334/001-005 23.11.2011 21.11.2011 Firdapse BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/09/601/001 23.11.2011 21.11.2011 Inovelon Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/06/378/001-017 23.11.2011 21.11.2011 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/06/368/001-168 23.11.2011 21.11.2011 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436/001-002 23.11.2011 21.11.2011 Rilonacept Regeneron Regeneron UK Limited 40 Bank Street, London, E14 5DS United Kingdom EU/1/09/582/001 23.11.2011 21.11.2011 Tygacil Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/06/336/001 23.11.2011 22.11.2011 Advagraf Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/07/387/001-026 24.11.2011 22.11.2011 Afinitor Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538/001-008 24.11.2011 22.11.2011 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430/001-002 24.11.2011 22.11.2011 Dynastat Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/209/001-008 24.11.2011 22.11.2011 Effentora Cephalon Europe 5 Rue Charles Martigny, Maisons-Alfort 94700, France EU/1/08/441/001-010 24.11.2011 22.11.2011 Exforge Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/370/001-039 24.11.2011 22.11.2011 Fabrazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/01/188/001-006 25.11.2011 22.11.2011 Grepid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/09/535/001-016 24.11.2011 22.11.2011 Imprida Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/373/001-039 24.11.2011 22.11.2011 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026/001-002 24.11.2011 22.11.2011 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278/001-016 24.11.2011 22.11.2011 Lyrica Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/04/279/001-044 24.11.2011 22.11.2011 Myozyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/333/001-003 24.11.2011 22.11.2011 Norvir Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/96/016/001 EU/1/96/016/003-008 24.11.2011 22.11.2011 Onglyza Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/09/545/001-015 24.11.2011 22.11.2011 Optaflu Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland EU/1/07/394/001-009 24.11.2011 22.11.2011 Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/578/001 24.11.2011 22.11.2011 PecFent Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom EU/1/10/644/001-006 24.11.2011 22.11.2011 Prepandrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique EU/1/08/453/002 24.11.2011 22.11.2011 Rasilez Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405/001-040 24.11.2011 22.11.2011 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267/001-006 EU/1/03/267/008-010 24.11.2011 22.11.2011 Riprazo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409/001-040 24.11.2011 22.11.2011 Riprazo HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/680/001-080 24.11.2011 22.11.2011 Sprimeo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-040 24.11.2011 22.11.2011 Tasigna Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/422/001-012 24.11.2011 22.11.2011 Thalidomide Celgene Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/08/443/001 24.11.2011 22.11.2011 Trisenox Cephalon Europe 5 Rue Charles Martigny, 94700 Maisons Alfort, Cedex, France EU/1/02/204/001 24.11.2011 22.11.2011 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529/001-005 25.11.2011 24.11.2011 Adenuric Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg EU/1/08/447/001-012 29.11.2011 24.11.2011 Atriance Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/403/001 1.12.2011 24.11.2011 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 30.11.2011 24.11.2011 Clopidogrel HCS HCS bvba H. Kennisstraat 53, B 2650 Edegem, Belgïe EU/1/10/651/001-015 29.11.2011 24.11.2011 Clopidogrel Teva Generics B.V. Teva Generics B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/650/001-015 29.11.2011 24.11.2011 Eucreas Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/425/001-018 28.11.2011 24.11.2011 Galvus Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/414/001-010 EU/1/07/414/018 29.11.2011 24.11.2011 Icandra Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/484/001-018 30.11.2011 24.11.2011 Intelence Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België EU/1/08/468/001-002 29.11.2011 24.11.2011 Jalra Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/485/001-011 29.11.2011 24.11.2011 ReFacto AF Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/103/001-008 29.11.2011 24.11.2011 Soliris Alexion Europe S.A.S. 25, boulevard de l'Amiral Bruix, 75016 Paris, France EU/1/07/393/001 29.11.2011 24.11.2011 Vimpat UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/08/470/001-017 29.11.2011 24.11.2011 Xiliarx Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/486/001-011 29.11.2011 24.11.2011 Zomarist Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/483/001-018 29.11.2011 24.11.2011 Zypadhera Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/479/001-003 28.11.2011 24.11.2011 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/1/96/022/009-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-040 28.11.2011 24.11.2011 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/99/125/001-020 28.11.2011 28.11.2011 Emend Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262/001-010 30.11.2011 28.11.2011 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-014 1.12.2011 28.11.2011 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-005 30.11.2011 28.11.2011 Zutectra Biotest Pharma GmbH Landsteinerstr.5, 63303 Dreieich, Deutschland EU/1/09/600/001 30.11.2011 28.11.2011 Zyllt KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/553/001-010 30.11.2011 5.12.2011 Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/185/001-022 EU/1/01/185/031-111 7.12.2011 5.12.2011 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419/001-012 7.12.2011 5.12.2011 Clopidogrel Acino Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/532/001-007 7.12.2011 5.12.2011 Clopidogrel Hexal Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/534/001-007 7.12.2011 5.12.2011 Controloc Control Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/515/001-004 7.12.2011 5.12.2011 Pantozol Control Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/517/001-004 7.12.2011 5.12.2011 Somac Control Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/516/001-004 7.12.2011 5.12.2011 Xenical Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/071/001-006 7.12.2011 7.12.2011 Clopidogrel Teva Pharma Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/561/001-011 9.12.2011 7.12.2011 Pantecta Control Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/518/001-004 9.12.2011 7.12.2011 Pantoloc Control Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/519/001-004 9.12.2011 7.12.2011 Prometax Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/092/013 EU/1/98/092/018-026 12.12.2011 7.12.2011 Torisel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/424/001 9.12.2011 8.12.2011 Ceplene EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland EU/1/08/477/001 12.12.2011 9.12.2011 Rasilamlo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/686/001-056 13.12.2011 9.12.2011 Xarelto Bayer Pharma AG 13342 Berlin, Deutschland EU/1/08/472/001-021 20.12.2011 9.12.2011 Zeffix Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/99/114/003 13.12.2011 14.12.2011 Clopidogrel ratiopharm Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/554/001-008 19.12.2011 14.12.2011 Emselex Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/04/294/001-028 19.12.2011 14.12.2011 GILENYA Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/677/001-005 20.12.2011 14.12.2011 Glivec Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 19.12.2011 14.12.2011 Insulatard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/233/010-012 21.12.2011 14.12.2011 Lucentis Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/374/001 19.12.2011 14.12.2011 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067/001-002 19.12.2011 14.12.2011 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221/001-016 19.12.2011 14.12.2011 Simulect Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/084/001-002 19.12.2011 14.12.2011 Vfend Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/212/001-026 19.12.2011 14.12.2011 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 19.12.2011 14.12.2011 Volibris Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/08/451/001-004 19.12.2011 19.12.2011 Advate Baxter AG Industriesstrasse 67, 1221 Vienna, Österreich EU/1/03/271/001-010 21.12.2011 19.12.2011 APTIVUS Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/05/315/001-002 21.12.2011 19.12.2011 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 21.12.2011 19.12.2011 Clopidogrel Acino Pharma GmbH Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/548/001-007 21.12.2011 19.12.2011 Emend Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262/001-008 21.12.2011 19.12.2011 Exjade Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/356/001-009 21.12.2011 19.12.2011 Fendrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique EU/1/04/299/001-003 21.12.2011 19.12.2011 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/357/001-008 EU/1/06/357/018-021 21.12.2011 19.12.2011 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145/001 21.12.2011 19.12.2011 Humira Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/03/256/001-010 21.12.2011 19.12.2011 Kentera Nicobrand Limited 189 Castleroe Road, Coleraine, BT51 3 RP Northern Ireland EU/1/03/270/001-005 21.12.2011 19.12.2011 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278/001-016 21.12.2011 19.12.2011 Noxafil Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/320/001 21.12.2011 19.12.2011 Pandemic influenza vaccine H5N1 BAXTER Baxter AG Industriestraße 67, A - 1221 Wien, Österreich EU/1/09/571/001 21.12.2011 19.12.2011 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique EU/1/08/452/001 21.12.2011 19.12.2011 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358/001-008 EU/1/06/358/018-021 21.12.2011 19.12.2011 Somavert Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/240/001-004 21.12.2011 19.12.2011 Synagis Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/99/117/001-002 21.12.2011 19.12.2011 Tasigna Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/422/001-012 21.12.2011 19.12.2011 Tesavel Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435/001-018 21.12.2011 19.12.2011 Tracleer Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220/001-006 21.12.2011 22.12.2011 Actos Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/00/150/001-030 29.12.2011 22.12.2011 Actos Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/00/150/001-030 29.12.2011 22.12.2011 Ambirix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique EU/1/02/224/001-005 27.12.2011 22.12.2011 Arzerra Glaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/625/001 EU/1/10/625/003 28.12.2011 22.12.2011 Competact Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/06/354/001-012 29.12.2011 22.12.2011 Competact Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/06/354/001-012 3.1.2012 22.12.2011 Glubrava Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/07/421/001-009 29.12.2011 22.12.2011 Glubrava Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/07/421/001-009 29.12.2011 22.12.2011 Glustin Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/00/151/001-024 29.12.2011 22.12.2011 Glustin Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/00/151/001-024 29.12.2011 22.12.2011 Invanz Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/02/216/001-002 3.1.2012 22.12.2011 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437/001-004 3.1.2012 22.12.2011 Januvia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383/001-018 5.1.2012 22.12.2011 Multaq Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/09/591/001-004 28.12.2011 22.12.2011 Multaq Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/09/591/001-004 29.12.2011 22.12.2011 Nevanac Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/07/433/001 3.1.2012 22.12.2011 Norvir Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/96/016/001 EU/1/96/016/003-008 28.12.2011 22.12.2011 Onglyza Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/09/545/001-015 3.1.2012 22.12.2011 Ozurdex Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland EU/1/10/638/001 4.1.2012 22.12.2011 Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/578/001 27.12.2011 22.12.2011 Prepandrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique EU/1/08/453/002 27.12.2011 22.12.2011 Renagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/123/005-013 27.12.2011 22.12.2011 Renvela Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland EU/1/09/521/001-007 27.12.2011 22.12.2011 Ristaben Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621/001-018 3.1.2012 22.12.2011 Tandemact Takeda Global Research and Development Centre (Europe) Ltd. 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/06/366/005-022 29.12.2011 22.12.2011 Tandemact Takeda Global Research and Development Centre (Europe) Ltd. 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/06/366/005-022 28.12.2011 22.12.2011 Vidaza Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom EU/1/08/488/001 28.12.2011 22.12.2011 Xelevia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382/001-018 3.1.2012 22.12.2011 Zavesca Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/238/001 28.12.2011





— 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 28.11.2011 Xigris Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/02/225/001-002 30.11.2011





— Suspension of a marketing authorization (Article 20 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 24.11.2011 Busilvex Pierre Fabre Médicament 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France EU/1/03/254/002 28.11.2011 24.11.2011 Caelyx Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/96/011/001-004 28.11.2011 24.11.2011 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 28.11.2011 24.11.2011 Vidaza Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom EU/1/08/488/001 25.11.2011 7.12.2011 Ecalta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/416/001-002 9.12.2011 7.12.2011 Luminity Lantheus MI UK Limited Festival House – 39 Oxford Street – Newbury – Berkshire RG14 1JG – United Kingdom EU/1/06/361/001-002 12.12.2011 12.12.2011 Vistide Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom EU/1/97/037/001 14.12.2011





— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2)): Accepted

Date of the Décision 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 9.12.2011 Inflacam Meloxicam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND EU/2/11/134/001-014 Chewable tablet Oral suspension Solution for injection QM01AC06 13.12.2011 9.12.2011 Panacur AquaSol Fenbendazole Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/11/135/001-003 Oral suspension QP52AC13 13.12.2011 14.12.2011 TruScient Dibotermin alfa Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/11/136/001 Kit for implant QM05BC01 19.12.2011





— 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 10.11.2011 ProMeris Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/06/064/001-004 15.11.2011 10.11.2011 ProMeris Duo Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/06/065/001-010 15.11.2011 10.11.2011 Zulvac 8 Bovis Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/09/105/001-002 15.11.2011 10.11.2011 Zulvac 8 Ovis Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/09/104/001-002 15.11.2011 16.11.2011 Prac-Tic Novartis Sanidad Animal S.L. Calle de la Marina, 206, E - Barcelona 08013, ESPANA EU/2/06/066/001-012 18.11.2011 24.11.2011 Coxevac CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France EU/2/10/110/001-002 29.11.2011 24.11.2011 Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/07/079/001-008 29.11.2011 28.11.2011 Melosus CP-Pharma Handelsgesellschaft mbH Ostlandring 13, D-31303 Burgdorf, Deutschland EU/2/10/116/004-006 30.11.2011 5.12.2011 Porcilis Porcoli Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/96/001/001-010 7.12.2011 9.12.2011 Masivet AB Science S.A. 3 avenue George V, 75008 Paris, France EU/2/08/087/001-002 13.12.2011 9.12.2011 Zulvac 1 Ovis Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/11/131/001-006 13.12.2011 14.12.2011 Trocoxil Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/08/084/001-005 19.12.2011 14.12.2011 Zulvac 1 Bovis Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/11/130/001-003 19.12.2011 19.12.2011 Meloxidyl CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France EU/2/06/070/001-008 21.12.2011 19.12.2011 Ypozane VIRBAC S.A. 1ère Avenue 2065 m L.I.D. – 06516 Carros – France EU/2/06/068/001-004 21.12.2011

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 UK - LONDON E14 4H

(1) OJ L 136, 30.4.2004, p. 1.

(2) OJ L 136, 30.4.2004, p. 1.