EN Official Journal of the European Union C 93/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 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 93/01

— 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 1.2.2013 Lyxumia lixisenatide Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/12/811 Solution for injection Pending 5.2.2013 1.2.2013 ZALTRAP aflibercept Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/12/814 Concentrate for solution for infusion L01XX 5.2.2013 20.2.2013 Adasuve loxapine Alexza UK Ltd. 10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom EU/1/13/823 Inhalation powder, pre-dispensed N05AH01 25.2.2013 25.2.2013 Selincro nalmefene H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/12/815 Film-coated tablet N07BB 27.2.2013





— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

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 12.2.2013 Istodax Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom — 14.2.2013 20.2.2013 Acrescent H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark — 22.2.2013 20.2.2013 Balaxur Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104, D-60318 Frankfurt am Main, Deutschland — 22.2.2013





— 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 1.2.2013 Ixiaro Intercell AG Campus Vienna Biocenter 3, A-1030 Wien, Österreich EU/1/08/501 5.2.2013 8.2.2013 Aflunov Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/658 12.2.2013 8.2.2013 Vibativ Theravance UK Limited 90 Fetter Lane London EC4A 1EQ United Kingdom EU/1/11/705 12.2.2013 12.2.2013 Adcirca Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/476 14.2.2013 13.2.2013 Cialis Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/02/237 15.2.2013 13.2.2013 Evicel Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België EU/1/08/473 15.2.2013 13.2.2013 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/03/247 15.2.2013 13.2.2013 Zostavax Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France EU/1/06/341 15.2.2013 18.2.2013 Advagraf Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/07/387 20.2.2013 18.2.2013 Aldurazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/253 20.2.2013 18.2.2013 BeneFIX Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/97/047 20.2.2013 18.2.2013 Caprelsa AstraZeneca AB Building 411A, Floor 4, SE-151 85 Södertälje, Sverige EU/1/11/749 20.2.2013 18.2.2013 Ilaris Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564 20.2.2013 18.2.2013 Karvea Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/97/049 20.2.2013 18.2.2013 Karvezide Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/98/085 20.2.2013 18.2.2013 Komboglyze Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/731 20.2.2013 18.2.2013 Modigraf Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/09/523 20.2.2013 18.2.2013 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 20.2.2013 18.2.2013 ProQuad Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France EU/1/05/323 20.2.2013 18.2.2013 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405 20.2.2013 18.2.2013 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491 20.2.2013 18.2.2013 Rasitrio Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/730 20.2.2013 20.2.2013 Arzerra Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/625 22.2.2013 20.2.2013 Effentora Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/08/441 22.2.2013 20.2.2013 M-M-RVAXPRO Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France EU/1/06/337 22.2.2013 25.2.2013 Humira AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/03/256 27.2.2013 25.2.2013 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436 27.2.2013 25.2.2013 Lumigan Allergan Pharmaceuticals Ireland, (514125) Castlebar Road, Westport, County Mayo, Ireland EU/1/02/205 27.2.2013 25.2.2013 Rasilamlo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/686 27.2.2013 28.2.2013 DuoCover Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/10/623 4.3.2013





— 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 13.2.2013 Semintra Telmisartan Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/12/146 Oral solution QC09CA07 15.2.2013 25.2.2013 Pexion Imepitoin Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/12/147 Tablet QN03AX90 27.2.2013





— 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 1.2.2013 Profender Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/05/054 5.2.2013 8.2.2013 Recocam Cross Vetpharm Group, Ltd Broomhill Road, Tallaght Dublin 24, Ireland EU/2/11/133 12.2.2013 12.2.2013 Inflacam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/11/134 14.2.2013 13.2.2013 Onsior Novartis Animal Health UK Ltd Frimley Business Park, Frimley/Camberley, Surrey, GU16 7SR, United Kingdom EU/2/08/089 15.2.2013 13.2.2013 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/07/078 15.2.2013 20.2.2013 Zulvac 1 Bovis Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/11/130 22.2.2013 20.2.2013 Zulvac 1 Ovis Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/11/131 22.2.2013 25.2.2013 BTVPUR AlSap 2-4 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/10/108 27.2.2013

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.