EN Official Journal of the European Union C 53/3

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2013 to 31 January 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 53/03

— 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 8.1.2013 Imatinib Teva imatinib Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/12/808 Capsule, hard Film-coated tablet L01XE01 10.1.2013 8.1.2013 Krystexxa pegloticase Savient Pharma Ireland Limited Mespil House, Sussex Road, Dublin 4, Ireland EU/1/12/810 Concentrate for solution for infusion M04AX02 10.1.2013 14.1.2013 Amyvid Florbetapir (18F) Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/12/805 Solution for injection V09AX05 17.1.2013 14.1.2013 Bexsero Meningococcal group B Vaccine (rDNA, component, adsorbed) Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 Suspension for injection J07AH09 18.1.2013 21.1.2013 BindRen colestilan Mitsubishi Pharma Europe Ltd. Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom EU/1/12/804 Film-coated tablet Granules Pending 23.1.2013 21.1.2013 Ryzodeg Insulin degludec/insulin aspart Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/806 Solution for injection Pending 23.1.2013 21.1.2013 Tresiba Insulin degludec Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/807 Solution for injection Pending 23.1.2013





— 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 14.1.2013 Abraxane Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/428 16.1.2013 14.1.2013 Entacapone Orion Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/708 17.1.2013 14.1.2013 Exelon Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/066 16.1.2013 14.1.2013 Ilaris Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564 16.1.2013 14.1.2013 Levodopa/Carbidopa/Entacapone Orion Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/706 17.1.2013 14.1.2013 Myocet Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/00/141 17.1.2013 14.1.2013 Neupro UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland EU/1/05/331 17.1.2013 14.1.2013 Prepandrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/08/453 17.1.2013 14.1.2013 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/06/380 17.1.2013 14.1.2013 Stalevo Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/03/260 16.1.2013 14.1.2013 Tandemact Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/06/366 17.1.2013 14.1.2013 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423 17.1.2013 14.1.2013 Volibris Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/08/451 17.1.2013 14.1.2013 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295 17.1.2013 14.1.2013 Zebinix BIAL - Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal EU/1/09/514 17.1.2013 17.1.2013 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442 22.1.2013 17.1.2013 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/391 21.1.2013 21.1.2013 Cialis Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/02/237 23.1.2013 21.1.2013 Levitra Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/248 23.1.2013 21.1.2013 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442 23.1.2013 21.1.2013 Rasilamlo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/686 23.1.2013 21.1.2013 Rasitrio Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/730 23.1.2013 21.1.2013 Vivanza Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/249 23.1.2013 24.1.2013 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom EU/1/04/276 29.1.2013 24.1.2013 Adcirca Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/476 29.1.2013 24.1.2013 Comtess Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/98/082 29.1.2013 24.1.2013 Ilaris Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564 29.1.2013 24.1.2013 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405 29.1.2013 28.1.2013 Olazax Disperzi Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika EU/1/09/592 30.1.2013 28.1.2013 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491 30.1.2013 28.1.2013 Trisenox Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/02/204 30.1.2013





— 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 24.1.2013 Riprazo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409 29.1.2013





— 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 17.1.2013 Pelzont Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/460 18.1.2013 17.1.2013 Tredaptive Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/459 18.1.2013 17.1.2013 Trevaclyn Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/458 18.1.2013





— 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 28.1.2013 Kexxtone Monensin sodium Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/12/145 Continuous release intraruminal device QA16QA06 30.1.2013





— 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 14.1.2013 Advocate Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/03/039 16.1.2013 14.1.2013 BLUEVAC BTV8 CZ Veterinaria, S.A. La Relva s/n, P.O. Box 16, E-36400 Porriño, España EU/2/11/122 16.1.2013 14.1.2013 Bovilis BTV8 Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/10/106 16.1.2013 14.1.2013 Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/07/079 16.1.2013 21.1.2013 Panacur AquaSol Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/11/135 23.1.2013 24.1.2013 Purevax RCP Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/04/052 29.1.2013 28.1.2013 Purevax RC Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/04/051 30.1.2013 28.1.2013 Purevax RCPCh Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/04/050 30.1.2013

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.

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