EN Official Journal of the European Union C 148/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 2012

(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 148/01

— 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 13.4.2012 Bronchitol Mannitol Pharmaxis Pharmaceuticals Limited The Priory, Stomp Road, Burnham, Buckinghamshire, SL1 7LW, United Kingdom EU/1/12/760/001-002 Inhalation powder, hard capsule R05CB16 18.4.2012 13.4.2012 Sabervel Irbesartan Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/12/765/001-006 Film-coated tablet C09CA04 17.4.2012 20.4.2012 Capecitabine Accord capecitabine Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom EU/1/12/762/001-018 Film-coated tablet L01BC06 25.4.2012 20.4.2012 Capecitabine Krka capecitabine KRKA, d.d Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia EU/1/12/763/001-018 Film-coated tablet L01BC06 25.4.2012 20.4.2012 Capecitabine Teva capecitabine TEVA Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/12/761/001-002 Film-coated tablet L01BC06 25.4.2012 20.4.2012 Nimenrix Meningococcal group A, C, W-135 and Y conjugate vaccine GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/12/767/001-007 Powder and solvent for solution for injection J07AH08 25.4.2012 20.4.2012 SANCUSO granisetron ProStrakan Limited Galabank Business Park, Galashiels, TD1 1QH, United Kingdom EU/1/12/766/001 Transdermal patch A04AA02 25.4.2012 20.4.2012 Zoledronic acid Actavis zoledronic acid Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland EU/1/12/759/001-003 Concentrate for solution for infusion M05BA08 26.4.2012 24.4.2012 Signifor pasireotide Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/12/753/001-012 Solution for injection H01CB05 27.4.2012





— 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 3.4.2012 Kinzalkomb Bayer Pharma AG 13342 Berlin, Deutschland EU/1/02/214/001-015 5.4.2012 4.4.2012 Humira Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/03/256/001-010 10.4.2012 4.4.2012 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/98/069/001a-001b EU/1/98/069/002a-002b EU/1/98/069/003a-003b EU/1/98/069/004a-004b EU/1/98/069/005a-005b EU/1/98/069/006a-006b EU/1/98/069/007a-007b EU/1/98/069/008-010 EU/1/98/069/011a-011b EU/1/98/069/012 11.4.2012 4.4.2012 Rebetol Schering Plough Europe Clos du Lynx 5, 1200 Bruxelles, Belgique – Lynx Binnenhof 5, 1200 Brussel, België EU/1/99/107/001-005 11.4.2012 4.4.2012 Telzir ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/04/282/001-002 11.4.2012 10.4.2012 Vedrop Orphan Europe SARL Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux - France EU/1/09/533/001-003 12.4.2012 13.4.2012 Advagraf Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/07/387/001-026 17.4.2012 13.4.2012 alli Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/401/007-016 17.4.2012 13.4.2012 Champix Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/360/001-013 17.4.2012 13.4.2012 Evoltra Genzyme Europe BV Gooimeer 10, 1411 DD Naarden, Nederland EU/1/06/334/001-005 17.4.2012 13.4.2012 Foscan Biolitec pharma Ltd United Drug House, Magna Drive, Dublin 24, Ireland EU/1/01/197/003-005 17.4.2012 13.4.2012 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-014 17.4.2012 13.4.2012 Prometax Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/092/001-026 17.4.2012 13.4.2012 Revatio Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/05/318/001 17.4.2012 13.4.2012 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom EU/1/07/391/001-004 17.4.2012 13.4.2012 Soliris Alexion Europe S.A.S. 25, boulevard de l'Amiral Bruix, 75016 Paris, France EU/1/07/393/001 17.4.2012 13.4.2012 Tyverb Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/440/001-006 17.4.2012 13.4.2012 Viramune Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/97/055/001-009 17.4.2012 13.4.2012 Volibris Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/08/451/001-004 17.4.2012 20.4.2012 Abraxane Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom EU/1/07/428/001 24.4.2012 20.4.2012 Aclasta Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/308/001-002 25.4.2012 20.4.2012 Aflunov Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/658/001-002 26.4.2012 20.4.2012 Altargo Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/390/001-004 26.4.2012 20.4.2012 Apidra Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/04/285/001-036 26.4.2012 20.4.2012 Ceplene EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland EU/1/08/477/001 24.4.2012 20.4.2012 Circadin RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom EU/1/07/392/001-003 25.4.2012 20.4.2012 Exelon Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/066/001-026 26.3.2012 20.4.2012 Focetria Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/07/385/001-002 EU/1/07/385/004 26.4.2012 20.4.2012 HALAVEN Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/11/678/001-002 25.4.2012 20.4.2012 Helixate NexGen Bayer Pharma AG 13342 Berlin, Deutschland EU/1/00/144/001-005 25.4.2012 20.4.2012 Humira Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/03/256/002-010 25.4.2012 20.4.2012 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/06/368/001-015 EU/1/06/368/020-024 EU/1/06/368/029-033 EU/1/06/368/037-042 EU/1/06/368/047-051 EU/1/06/368/056-057 EU/1/06/368/088-102 EU/1/06/368/113-150 EU/1/06/368/163-168 25.4.2012 20.4.2012 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/97/030/028-195 26.4.2012 20.4.2012 IOA N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/11/689/001-002 24.4.2012 20.4.2012 Iressa AstraZeneca AB S 151 85 Sodertalje, Sverige EU/1/09/526/001-002 26.4.2012 20.4.2012 Kogenate Bayer Bayer Pharma AG 13342 Berlin, Deutschland EU/1/00/143/004-013 25.4.2012 20.4.2012 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134/001-037 25.4.2012 20.4.2012 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 26.4.2012 20.4.2012 NovoNorm Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/98/076/004-006 EU/1/98/076/011-013 EU/1/98/076/018-020 EU/1/98/076/022-024 26.3.2012 20.4.2012 Opgenra Olympus Biotech International Limited Raheen Business Park, Limerick, Ireland EU/1/08/489/001-002 24.4.2012 20.4.2012 Optimark Covidien Deutschland GmbH Gewerbepark 1, 93333 Neustadt/Donau, Deutschland EU/1/07/398/001-014 26.3.2012 20.4.2012 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133/001-032 25.4.2012 20.4.2012 Pelzont Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/460/001-014 25.4.2012 20.4.2012 Prandin Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/00/162/003-005 EU/1/00/162/009-011 EU/1/00/162/015-017 EU/1/00/162/019-021 26.4.2012 20.4.2012 Preotact Nycomed Danmark ApS Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/06/339/001-003 25.4.2012 20.4.2012 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618/001-004 24.4.2012 20.4.2012 ProQuad Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/05/323/001-013 26.4.2012 20.4.2012 Rasilamlo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/686/001-056 24.4.2012 20.4.2012 Rasilez Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405/001-040 24.4.2012 20.4.2012 Riprazo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409/001-040 24.4.2012 20.4.2012 Riprazo HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/680/001-080 24.4.2012 20.4.2012 Samsca Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom EU/1/09/539/001-004 24.4.2012 20.4.2012 Sebivo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/388/001-003 26.4.2012 20.4.2012 Silodyx Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/607/001-014 24.4.2012 20.4.2012 Sprimeo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-040 24.4.2012 20.4.2012 Sprimeo HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/683/001-080 24.4.2012 20.4.2012 Tracleer Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220/001-006 26.4.2012 20.4.2012 Tredaptive Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/459/001-014 25.4.2012 20.4.2012 Trevaclyn Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/458/001-014 25.4.2012 20.4.2012 Urorec Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/608/001-014 24.4.2012 20.4.2012 Ventavis Bayer Pharma AG 13342 Berlin, Deutschland EU/1/03/255/001-008 26.4.2012 20.4.2012 Vfend Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/212/001-026 25.4.2012 20.4.2012 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529/001-005 24.4.2012 20.4.2012 Vidaza Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom EU/1/08/488/001 24.4.2012 20.4.2012 Xenical Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/071/001-006 24.4.2012 20.4.2012 Yttriga Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Str. 10, 13125 Berlin, Deutschland EU/1/05/322/001-002 26.4.2012 20.4.2012 Zoely Theramex S.r.l. Via Messina 38, 20154 Milano, Italia EU/1/11/690/001-002 24.4.2012 24.4.2012 Menveo Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/614/001-003 27.4.2012 24.4.2012 Rasilez HCT Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491/001-080 27.4.2012 24.4.2012 Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland EU/1/09/605/001-012 27.4.2012 26.4.2012 Revolade GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland EU/1/10/612/001-006 30.4.2012 26.4.2012 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698/001-002 30.4.2012





— 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 20.4.2012 PhotoBarr Pinnacle Biologics B.V. p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, 1043 DP Amsterdam, Nederland EU/1/04/272/001-002 25.4.2012 24.4.2012 Refludan Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom EU/1/97/035/001-004 27.4.2012





— 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 10.4.2012 Slentrol Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/07/071/001-003 12.4.2012 13.4.2012 Cerenia Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/06/062/005 17.4.2012 20.4.2012 BTVPUR AlSap 1 MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/10/112/001-005 25.4.2012 20.4.2012 BTVPUR AlSap 1-8 MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/10/113/001-005 25.4.2012 20.4.2012 Loxicom Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090/001-027 24.4.2012 20.4.2012 Meloxivet Janssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse, België EU/2/07/077/001-005 25.4.2012

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.