EN Official Journal of the European Union C 311/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013

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

2013/C 311/01

— 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 6.9.2013 Procysbi mercaptamine (cysteamine bitartrate) Raptor Pharmaceuticals Europe BV Naritaweg 165, NL-1043 BW Amsterdam, Nederland EU/1/13/861 Gastro-resistant capsule, hard A16AA04 10.9.2013 6.9.2013 Provenge Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T) Dendreon UK Limited 41 Chalton Street, London NW1 1JD, United Kingdom EU/1/13/867 Dispersion for infusion L03AX17 10.9.2013 10.9.2013 Inflectra Infliximab Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/13/854 powder for concentrate for solution for infusion L04AB02 12.9.2013 10.9.2013 Remsima Infliximab Celltrion Healthcare Hungary Kft. Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország EU/1/13/853 powder for concentrate for solution for infusion L04AB02 12.9.2013 12.9.2013 Lemtrada Alemtuzumab Genzyme Therapeutics Ltd 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom EU/1/13/869 Concentrate for solution for infusion Pending 16.9.2013 12.9.2013 Orphacol Cholic acid Laboratoires CTRS (Cell Therapies Research & Services) 69 rue d’Aguesseau, F-92100 Boulogne-Billancourt, France EU/1/13/870 Capsule, hard A05AA03 16.9.2013 19.9.2013 Incresync alogliptin / pioglitazone Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/13/842 Film-coated tablet A10BD09 23.9.2013 19.9.2013 Tybost cobicistat Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/872 Film-coated tablet V03AX03 23.9.2013 19.9.2013 Ultibro Breezhaler indacaterol/glycopyrronium bromide Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/13/862 Inhalation powder, hard capsule R03AL04 23.9.2013 19.9.2013 Vipdomet alogliptin / metformin Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/13/843 Film-coated tablet A10BD13 23.9.2013 19.9.2013 Vipidia alogliptin Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/13/844 Film-coated tablet A10BH04 23.9.2013 19.9.2013 Xoterna Breezhaler indacaterol/glycopyrronium bromide Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/13/863 Inhalation powder, hard capsule R03AL04 23.9.2013 25.9.2013 EVARREST Human fibrinogen/Human thrombin Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België EU/1/13/868 Sealant matrix B02BC30 27.9.2013 25.9.2013 Giotrif afatinib Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/13/879 Film-coated tablet L01XE13 27.9.2013 25.9.2013 Imatinib Medac Imatinib medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/13/876 Capsule, hard L01XE01 27.9.2013 27.9.2013 Ovaleap Follitropin alfa Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/13/871 Solution for injection G03GA05 1.10.2013





— 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 6.9.2013 Labazenit LABORATOIRES SMB SA 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België — 10.9.2013





— 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 3.9.2013 Neulasta Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/02/227 5.9.2013 3.9.2013 Simponi Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland EU/1/09/546 5.9.2013 3.9.2013 Vibativ Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom EU/1/11/705 5.9.2013 3.9.2013 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704 5.9.2013 3.9.2013 Xeplion Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/672 5.9.2013 5.9.2013 Mepact Takeda France SAS Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France EU/1/08/502 9.9.2013 9.9.2013 IDflu Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507 10.9.2013 9.9.2013 Intanza Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France EU/1/08/505 10.9.2013 12.9.2013 Cystagon Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/97/039 16.9.2013 12.9.2013 Puregon Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/008 16.9.2013 19.9.2013 Elaprase Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige EU/1/06/365 23.9.2013 19.9.2013 Elonva Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/609 23.9.2013 19.9.2013 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/97/030 23.9.2013 19.9.2013 NexoBrid MediWound Germany GmbH Eisenstr. 5, D-65428 Ruesselsheim, Deutschland EU/1/12/803 23.9.2013 19.9.2013 Orgalutran Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/130 23.9.2013 19.9.2013 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/06/380 23.9.2013 19.9.2013 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/06/380 23.9.2013 19.9.2013 Revolade GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland EU/1/10/612 23.9.2013 19.9.2013 Savene Norgine B.V. Hogehilweg 7, 1101 CA Amsterdam ZO, Nederland EU/1/06/350 23.9.2013 19.9.2013 Simponi Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland EU/1/09/546 23.9.2013 19.9.2013 Stelara Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/494 23.9.2013 24.9.2013 Intanza Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France EU/1/08/505 26.9.2013 24.9.2013 TOBI Podhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/10/652 26.9.2013 25.9.2013 IDflu Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507 27.9.2013 25.9.2013 Multaq Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/09/591 27.9.2013 25.9.2013 Resolor Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/09/581 27.9.2013 25.9.2013 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492 30.9.2013





— 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 3.9.2013 Rasitrio Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/730 5.9.2013





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 12.9.2013 Apoquel Oclacitinib maleate Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/13/154 Film-coated tablet QD11AH90 16.9.2013 19.9.2013 Trifexis Spinosad / Milbemycin oxime Eli Lilly and Company Ltd Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/13/155 Chewable tablet QP54AB51 23.9.2013





— 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 12.9.2013 Equip WNV Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/08/086 16.9.2013 13.9.2013 Zulvac 8 Bovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/105 17.9.2013 13.9.2013 Zulvac 8 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/104 17.9.2013 24.9.2013 Masivet AB Science S.A. 3 avenue George V, F-75008 Paris, France EU/2/08/087 26.9.2013 25.9.2013 Melovem Dopharma Research B.V. Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland EU/2/09/098 27.9.2013





— 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 19.9.2013 Netvax Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/09/093 23.9.2013

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.