EN Official Journal of the European Union C 184/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 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 184/01

— 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 16.5.2013 HyQvia human normal immunoglobulin Baxter Innovations GmbH Industriestraße 67, A-1221 Wien, Österreich EU/1/13/840 Solution for infusion J06BA 22.5.2013 16.5.2013 Voriconazole Accord voriconazole Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom EU/1/13/835 Film-coated tablet J02AC03 22.5.2013 24.5.2013 Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (as fumarate) Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/830 Film-coated tablet J05AR09 27.5.2013





— 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 14.5.2013 Qsiva VIVUS BV Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland — 16.5.2013 29.5.2013 Kynamro Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland — 31.5.2013 31.5.2013 Raxone Santhera Pharmaceuticals (Deutschland) GmbH Wallbrunnstrasse 24, D-79539 Lörrach, Deutschland — 4.6.2013





— 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 3.5.2013 Nevanac Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/07/433 7.5.2013 3.5.2013 Votrient Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/628 7.5.2013 6.5.2013 Vibativ Theravance UK Limited 90 Fetter Lane, London EC4A 1EQ, United Kingdom EU/1/11/705 8.5.2013 14.5.2013 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/03/251 16.5.2013 14.5.2013 Olanzapine Cipla Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom EU/1/07/426 16.5.2013 16.5.2013 Ozurdex Allergan Pharmaceuticals Ireland, (514125) Castlebar Road, Westport, County Mayo, Ireland EU/1/10/638 22.5.2013 16.5.2013 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295 22.5.2013 22.5.2013 Adcirca Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/476 24.5.2013 22.5.2013 Aloxi Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland EU/1/04/306 27.5.2013 22.5.2013 Leganto UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland EU/1/11/695 27.5.2013 22.5.2013 Olanzapine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/08/475 24.5.2013 22.5.2013 Xarelto Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/08/472 24.5.2013 23.5.2013 Trizivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/00/156 28.5.2013 27.5.2013 Afinitor Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538 29.5.2013 27.5.2013 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300 29.5.2013 27.5.2013 Combivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/98/058 29.5.2013 27.5.2013 DuoCover Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/10/623 29.5.2013 27.5.2013 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720 29.5.2013 27.5.2013 Ixiaro Intercell Austria AG Campus Vienna Biocenter 3, A-1030 Wien, Österreich EU/1/08/501 29.5.2013 27.5.2013 Kivexa ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/04/298 29.5.2013 27.5.2013 Neupro UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland EU/1/05/331 29.5.2013 27.5.2013 PANTECTA Control Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/518 29.5.2013 27.5.2013 PANTOLOC Control Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/519 29.5.2013 27.5.2013 Relistor TMC Pharma Services Ltd. Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom EU/1/08/463 29.5.2013 27.5.2013 Samsca Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom. EU/1/09/539 29.5.2013 27.5.2013 Zometa Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/176 29.5.2013 27.5.2013 Zypadhera Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/479 29.5.2013 27.5.2013 Zyprexa Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/96/022 29.5.2013 27.5.2013 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/99/125 29.5.2013 29.5.2013 Pritor Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/98/089 31.5.2013 29.5.2013 PritorPlus Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/02/215 31.5.2013 30.5.2013 Clopidogrel Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/08/465 3.6.2013 30.5.2013 CONTROLOC Control Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/515 3.6.2013 30.5.2013 DuoPlavin Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France EU/1/10/619 3.6.2013 30.5.2013 Epivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/96/015 3.6.2013 30.5.2013 Iscover Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/98/070 3.6.2013 30.5.2013 Kinzalkomb Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/02/214 3.6.2013 30.5.2013 Kinzalmono Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/98/091 3.6.2013 30.5.2013 Micardis Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/98/090 3.6.2013 30.5.2013 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/02/213 3.6.2013 30.5.2013 PANTOZOL Control Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/517 3.6.2013 30.5.2013 PegIntron Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/131 3.6.2013 30.5.2013 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France EU/1/98/069 3.6.2013 30.5.2013 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492 3.6.2013 30.5.2013 SOMAC Control Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/516 3.6.2013 30.5.2013 ViraferonPeg Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/132 3.6.2013 31.5.2013 Imatinib Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/12/808 4.6.2013





— 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 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 3.5.2013 Oncept IL-2 Feline interleukin-2 recombinant canarypox virus (vCP1338) Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/150 Lyophilisate and solvent for suspension for injection QL03AX 7.5.2013





— 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 6.5.2013 BTVPUR AlSap 1 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/10/112 13.5.2013 6.5.2013 BTVPUR AlSap 1-8 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/10/113 13.5.2013 14.5.2013 Cerenia Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/06/062 16.5.2013 14.5.2013 Posatex Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/08/081 16.5.2013 16.5.2013 Convenia Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/06/059 22.5.2013 16.5.2013 Suvaxyn PCV Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/099 22.5.2013 16.5.2013 Zulvac 1 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/11/131 22.5.2013 16.5.2013 Zulvac 8 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/104 22.5.2013 22.5.2013 Draxxin Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/03/041 24.5.2013 22.5.2013 Improvac Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/095 25.5.2013 22.5.2013 Pirsue Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/00/027 24.5.2013 22.5.2013 Poulvac E. coli Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/12/140 24.5.2013 22.5.2013 Quadrisol Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/97/005 24.5.2013 22.5.2013 Stronghold Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/99/014 24.5.2013 22.5.2013 Zulvac 1+8 Bovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/12/139 24.5.2013 22.5.2013 Zulvac 1 Bovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/11/130 24.5.2013 22.5.2013 Zulvac 8 Bovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/105 24.5.2013 23.5.2013 Naxcel Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/05/053 27.5.2013 23.5.2013 TruScient Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/11/136 27.5.2013 27.5.2013 Equip WNV Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/08/086 29.5.2013 27.5.2013 Fevaxyn Pentofel Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/96/002 29.5.2013 27.5.2013 Palladia Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/100 29.5.2013 27.5.2013 Slentrol Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/07/071 29.5.2013 27.5.2013 Zulvac 1+8 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/11/120 29.5.2013 30.5.2013 Trocoxil Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/08/084 3.6.2013





— Withdrawal of a marketing authorization (Article 38 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 22.5.2013 Nobivac Piro Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/04/046 24.5.2013

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.