EN Official Journal of the European Union C 282/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013

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

2013/C 282/01

— 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 5.8.2013 Pomalidomide Celgene Pomalidomide Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/13/850 Capsule, hard L04AX06 8.8.2013 5.8.2013 Somatropin Biopartners somatropin BioPartners GmbH Kaiserpassage 11, D-72764 Reutlingen, Deutschland EU/1/13/849 Powder and solvent for prolonged-release suspension for injection H01AC01 8.8.2013 12.8.2013 Voncento human coagulation factor VIII/human von Willebrand factor CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/13/857 Powder and solvent for solution for injection/infusion B02BD06 14.8.2013 26.8.2013 AUBAGIO Teriflunomide Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/13/838 Film-coated tablet L04AA31 29.8.2013 26.8.2013 Cholib fenofibrate/simvastatin Abbott Healthcare Products Ltd Mansbridge Road, West End Southampton, SO18 3JD, United Kingdom EU/1/13/866 Film-coated tablet C10BA04 28.8.2013 26.8.2013 Nexium Control esomeprazole AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/13/860 Gastro-resistant tablet A02BC05 29.8.2013 26.8.2013 Stivarga regorafenib Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/13/858 Film-coated tablet L01XE21 29.8.2013 26.8.2013 Tafinlar DABRAFENIB GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland EU/1/13/865 Capsule, hard L01XE23 29.8.2013





— 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 5.8.2013 Icandra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/484 8.8.2013 5.8.2013 Marixino Consilient Health Ltd. Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland EU/1/13/820 8.8.2013 5.8.2013 Rasilamlo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/686 8.8.2013 5.8.2013 Xarelto Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/08/472 8.8.2013 5.8.2013 Zomarist Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/483 8.8.2013 12.8.2013 Circadin RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom EU/1/07/392 14.8.2013 12.8.2013 Pixuvri CTI Life Sciences Ltd Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom EU/1/12/764 14.8.2013 12.8.2013 Signifor Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/12/753 14.8.2013 12.8.2013 Twynsta Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/10/648 14.8.2013 12.8.2013 Zavesca Actelion Registration Ltd Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom EU/1/02/238 14.8.2013 14.8.2013 Conbriza Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/511 19.8.2013 14.8.2013 FLUENZ MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland EU/1/10/661 19.8.2013 14.8.2013 IOA Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland EU/1/11/689 19.8.2013 26.8.2013 ADCETRIS Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/12/794 28.8.2013 26.8.2013 Azarga Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/08/482 29.8.2013 26.8.2013 Ceplene Meda AB Box 906, SE-170 09 Solna, Sverige EU/1/08/477 28.8.2013 26.8.2013 Eliquis Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/691 29.8.2013 26.8.2013 Eylea Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/12/797 28.8.2013 26.8.2013 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145 28.8.2013 26.8.2013 Hirobriz Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/594 29.8.2013 26.8.2013 Ifirmasta Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/480 29.8.2013 26.8.2013 Ilaris Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564 28.8.2013 26.8.2013 Inlyta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/777 29.8.2013 26.8.2013 Invega Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/07/395 28.8.2013 26.8.2013 Keppra UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/00/146 29.8.2013 26.8.2013 Onbrez Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/593 29.8.2013 26.8.2013 Oslif Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/586 28.8.2013 26.8.2013 Pramipexole Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/08/490 29.8.2013 26.8.2013 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311 29.8.2013 26.8.2013 Tysabri Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/06/346 29.8.2013 26.8.2013 Ventavis Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/255 29.8.2013 26.8.2013 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 29.8.2013 26.8.2013 Zypadhera Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/479 29.8.2013





— 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 5.8.2013 Econor Novartis Animal Health Austria GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/2/98/010 9.8.2013 12.8.2013 Trocoxil Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/08/084 14.8.2013 14.8.2013 Cerenia Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/06/062 19.8.2013

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.