EN Official Journal of the European Union C 361/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2015 to 30 September 2015

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

(2015/C 361/01)

— 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 8.9.2015 Ivabradine Anpharm ivabradine ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. ul. Annopol 6B, 03-236 Warszawa, Polska EU/1/15/1041 Film-coated tablet C01EB17 10.9.2015 8.9.2015 Raxone idebenone Santhera Pharmaceuticals (Deutschland) GmbH Marie-Curie Strasse 8, 79539 Lörrach, Deutschland EU/1/15/1020 Film-coated tablet N07 10.9.2015 14.9.2015 Pemetrexed Lilly pemetrexed Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/15/1034 Intravenous use L01BA04 16.9.2015 17.9.2015 Intuniv guanfacine Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/15/1040 Prolonged-release tablet C02AC02 21.9.2015 18.9.2015 Pemetrexed Sandoz pemetrexed Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/15/1037 Powder for concentrate for solution for infusion L01BA04 23.9.2015 18.9.2015 Zalviso Sufentanil Grünenthal GmbH Zieglerstrasse 6, D-52078, Aachen, Deutschland EU/1/15/1042 Sublingual tablet N01AH03 22.9.2015 18.9.2015 Zerbaxa ceftolozane/tazobactam Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1032 Powder for concentrate for solution for infusion J01DI54 22.9.2015 23.9.2015 Fexeric ferric citrate coordination complex Keryx Biopharma UK Ltd Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom EU/1/15/1039 Film-coated tablet V03AE 28.9.2015 23.9.2015 Praluent alirocumab Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/15/1031 Solution for injection C10 25.9.2015

— 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 8.9.2015 ATryn GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom EU/1/06/355 10.9.2015 8.9.2015 Daklinza Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/14/939 10.9.2015 8.9.2015 Ebixa H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/02/219 10.9.2015 8.9.2015 Enbrel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/126 10.9.2015 8.9.2015 Esbriet Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/11/667 10.9.2015 8.9.2015 Extavia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/454 10.9.2015 8.9.2015 Grastofil Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland EU/1/13/877 10.9.2015 8.9.2015 Hirobriz Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/594 10.9.2015 8.9.2015 Plegridy Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/14/934 10.9.2015 8.9.2015 Xofigo Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/13/873 10.9.2015 8.9.2015 Xyrem UCB Pharma Ltd 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom EU/1/05/312 10.9.2015 10.9.2015 ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/794 14.9.2015 14.9.2015 Betmiga Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/12/809 16.9.2015 14.9.2015 Elaprase Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige EU/1/06/365 16.9.2015 14.9.2015 Quinsair Aptalis Pharma SAS Route de Bû, F-78550 Houdan, France EU/1/14/973 16.9.2015 18.9.2015 Evoltra Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/334 22.9.2015 18.9.2015 Iclusig ARIAD Pharma Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom EU/1/13/839 22.9.2015 18.9.2015 Imvanex Bavarian Nordic A/S Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark EU/1/13/855 22.9.2015 18.9.2015 INOmax Linde Healthcare AB SE-181 81 Lidingö, Sverige EU/1/01/194 22.9.2015 18.9.2015 Metalyse Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/00/169 22.9.2015 18.9.2015 Perjeta Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/813 22.9.2015 18.9.2015 Ruconest Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland EU/1/10/641 22.9.2015 18.9.2015 Sebivo Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/388 22.9.2015 18.9.2015 Spedra Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/13/841 22.9.2015 18.9.2015 TachoSil Takeda Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich EU/1/04/277 22.9.2015 18.9.2015 Visudyne Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/00/140 22.9.2015 23.9.2015 Ilaris Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/564 28.10.2015 23.9.2015 Inflectra Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/13/854 25.9.2015 23.9.2015 Toviaz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/386 25.9.2015 23.9.2015 Trajenta Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/11/707 25.9.2015 23.9.2015 Viagra Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/98/077 28.9.2015 30.9.2015 Arixtra Aspen Pharma Trading Limited 3016 Lake Drive Citywest Business Campus Dublin 24 Ireland EU/1/02/206 2.10.2015 30.9.2015 Iasibon Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/10/659 2.10.2015 30.9.2015 Sifrol Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/050 2.10.2015 30.9.2015 Vibativ Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom EU/1/11/705 2.10.2015

— 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 23.9.2015 Biograstim AbZ-Pharma GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/450 25.9.2015

— Issuing 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 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 8.9.2015 FORTEKOR PLUS pimobendan/benazepril Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom EU/2/15/185 Tablet QC09BX90 10.9.2015 8.9.2015 Novaquin meloxicam Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/15/186 Oral suspension QM01AC06 10.9.2015 8.9.2015 Vectormune ND Cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain CEVA-Phylaxia Co. Ltd Budapest, Szállás u. 5, 1107 MAGYARORSZÁG EU/2/15/188 Suspension and solvent for suspension for injection QI01AD 10.9.2015

— 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 8.9.2015 BTVPUR AlSap 1 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/10/112 10.9.2015 8.9.2015 BTVPUR AlSap 1-8 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/10/113 10.9.2015 8.9.2015 Meloxoral Le Vet B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/10/111 10.9.2015 18.9.2015 Onsior Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom EU/2/08/089 22.9.2015

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.