EN Official Journal of the European Union C 208/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2017 to 31 May 2017

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

(2017/C 208/01)

— Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 8.5.2017 Dinutuximab beta Apeiron dinutuximab beta APEIRON Biologics AG Campus Vienna Biocenter 5, A-1030 Wien, Österreich EU/1/17/1191 Concentrate for solution for infusion L01XC 11.5.2017 22.5.2017 Axumin fluciclovine (18F) Blue Earth Diagnostics Ltd 215 Euston Road, London NW1 2BE, United Kingdom EU/1/17/1186 Solution for injection V09IX12 24.5.2017 22.5.2017 Fampyra fampridine Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/11/699 Prolonged-release tablet N07XX07 24.5.2017 22.5.2017 Ivabradine Accord ivabradine Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/17/1190 Film-coated tablet C01EB17 24.5.2017 24.5.2017 Trumenba meningococcal group B vaccine (recombinant, adsorbed) Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/17/1187 Suspension for injection J07AH09 30.5.2017 30.5.2017 Brineura cerliponase alfa BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/17/1192 Solution for infusion A16AB 1.6.2017 30.5.2017 Spinraza nusinersen Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/17/1188 Solution for injection Pending 1.6.2017

— Modification of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 2.5.2017 Adempas Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/907 4.5.2017 2.5.2017 Emtricitabine/Tenofovir disoproxil Krka Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/16/1151 4.5.2017 2.5.2017 KEYTRUDA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1024 4.5.2017 2.5.2017 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618 4.5.2017 2.5.2017 Xenical CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24, 17489 Greifswald, Deutschland EU/1/98/071 4.5.2017 4.5.2017 Ebymect AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/15/1051 8.5.2017 4.5.2017 Imatinib Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/845 8.5.2017 4.5.2017 Qutenza Grünenthal GmbH Zieglerstrasse 6, D-52078, Aachen, Deutschland EU/1/09/524 8.5.2017 8.5.2017 Akynzeo Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland EU/1/15/1001 11.5.2017 8.5.2017 Glivec Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/01/198 11.5.2017 8.5.2017 Ivabradine Anpharm ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. ul. Annopol 6B, 03-236 Warszawa, Polska EU/1/15/1041 11.5.2017 8.5.2017 Pergoveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/07/396 11.5.2017 8.5.2017 Rasagiline Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/16/1090 11.5.2017 8.5.2017 Simbrinza Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/14/933 11.5.2017 8.5.2017 Xarelto Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/08/472 11.5.2017 16.5.2017 Azarga Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/08/482 18.5.2017 16.5.2017 DuoTrav Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/06/338 18.5.2017 16.5.2017 Emadine Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/98/095 18.5.2017 16.5.2017 Feraccru Shield TX (UK) Limited Gateshead Quays, NE8 3DF, United Kingdom EU/1/15/1075 18.5.2017 16.5.2017 Lysodren Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/04/273 18.5.2017 16.5.2017 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067 18.5.2017 16.5.2017 Marixino Consilient Health Ltd 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland EU/1/13/820 18.5.2017 16.5.2017 Nevanac Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/07/433 18.5.2017 16.5.2017 Obizur Baxalta Innovations GmbH Industriestrasse 67, A-1221 Wien, Österreich EU/1/15/1035 18.5.2017 16.5.2017 Tygacil Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/336 18.5.2017 18.5.2017 Brilique AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/10/655 23.5.2017 18.5.2017 Desloratadine Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/11/745 23.5.2017 18.5.2017 Desloratadine ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/11/746 23.5.2017 18.5.2017 Fampyra Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/11/699 23.5.2017 18.5.2017 Ratiograstim ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/444 23.5.2017 18.5.2017 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/95/002 23.5.2017 18.5.2017 Zalasta Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/07/415 22.5.2017 18.5.2017 Zelboraf Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/12/751 23.5.2017 22.5.2017 Aerinaze Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/399 24.5.2017 22.5.2017 Clopidogrel BGR Laboratoires BIOGARAN 15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France EU/1/09/558 24.5.2017 22.5.2017 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/12/792 24.5.2017 22.5.2017 Faslodex AstraZeneca UK Limited Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom EU/1/03/269 24.5.2017 22.5.2017 Inlyta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/777 24.5.2017 22.5.2017 IntronA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/127 24.5.2017 22.5.2017 PHEBURANE Lucane Pharma 172 rue de Charonne, 75011 Paris, France EU/1/13/822 24.5.2017 22.5.2017 Rasilez Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/405 24.5.2017 22.5.2017 Respreeza CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/15/1006 24.5.2017 22.5.2017 Sildenafil Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/09/595 24.5.2017 22.5.2017 Tasigna Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/422 24.5.2017 22.5.2017 Temozolomide Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/10/615 24.5.2017 22.5.2017 Zeffix Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/99/114 24.5.2017 22.5.2017 Zoledronic acid Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/771 24.5.2017 22.5.2017 Zoledronic acid Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/772 24.5.2017 24.5.2017 Aerius Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/160 30.5.2017 24.5.2017 Azomyr Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/157 30.5.2017 24.5.2017 Busilvex Pierre Fabre Médicament 45 place Abel Gance, F-92654 Boulogne-Billancourt Cedex, France EU/1/03/254 30.5.2017 24.5.2017 Cotellic Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/15/1048 31.5.2017 24.5.2017 Desloratadine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/732 30.5.2017 24.5.2017 Ecalta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/416 30.5.2017 24.5.2017 Epivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/96/015 30.5.2017 24.5.2017 Fasturtec Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/00/170 30.5.2017 24.5.2017 Ferriprox Apotex Europe B.V. Darwinweg 20, NL-2333 CR Leiden, Nederland EU/1/99/108 30.5.2017 24.5.2017 Harvoni Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/958 30.5.2017 24.5.2017 Imnovid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/13/850 30.5.2017 24.5.2017 Kaletra AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/01/172 30.5.2017 24.5.2017 Memantine LEK Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/13/826 31.5.2017 24.5.2017 Mirvaso Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France EU/1/13/904 30.5.2017 24.5.2017 Neoclarityn Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/161 30.5.2017 24.5.2017 NovoThirteen Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/775 30.6.2017 24.5.2017 Tafinlar Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/865 30.5.2017 24.5.2017 Tasigna Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/422 30.5.2017 24.5.2017 Zoledronic acid Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/12/786 30.5.2017 31.5.2017 Azopt Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/00/129 2.6.2017 31.5.2017 Benepali Samsung Bioepis UK Limited 3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom EU/1/15/1074 2.6.2017 31.5.2017 Chenodeoxycholic acid Leadiant Leadiant GmbH Liebherrstr. 22, 80538 München, Deutschland EU/1/16/1110 2.6.2017 31.5.2017 Clopidogrel Apotex Apotex Europe B.V. Darwinweg 20, NL-2333 CR Leiden, Nederland EU/1/09/568 2.6.2017 31.5.2017 Elocta Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/15/1046 2.6.2017 31.5.2017 InductOs Medtronic BioPharma B.V. Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland EU/1/02/226 2.6.2017 31.5.2017 Lopinavir/Ritonavir Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/15/1067 2.6.2017 31.5.2017 Odomzo Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/15/1030 2.6.2017 31.5.2017 Sycrest Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland EU/1/10/640 2.6.2017 31.5.2017 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698 2.6.2017

— Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 15.5.2017 Zeleris florfenicol/meloxicam Ceva Santé Animale 10 av. de La Ballastière, 33500 Libourne, France EU/2/17/210 Solution for injection QJ01BA99 17.5.2017 17.5.2017 RESPIPORC FLUpan H1N1 Porcine influenza vaccine (inactivated) IDT Biologika GmbH Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland EU/2/17/209 Suspension for injection QI09AA03 19.5.2017 24.5.2017 Ingelvac PCV FLEX Porcine circovirus vaccine (inactivated) Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/17/208 Suspension for injection QI09AA07 30.5.2017

— Modification of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 5.5.2017 Activyl Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/10/118 9.5.2017 5.5.2017 Kexxtone Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/12/145 9.5.2017 5.5.2017 Versican Plus Pi/L4R Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/173 9.5.2017 15.5.2017 NEXGARD SPECTRA Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/14/177 17.5.2017 15.5.2017 Novem Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/042 17.5.2017 15.5.2017 Poulvac E. coli Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/140 17.5.2017 15.5.2017 Zactran Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/08/082 17.5.2017 17.5.2017 Suprelorin VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France EU/2/07/072 19.5.2017 17.5.2017 Suvaxyn Circo + MH RTU Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/15/190 22.5.2017 24.5.2017 Activyl Tick Plus Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/11/137 30.5.2017 24.5.2017 Profender Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/05/054 30.5.2017

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

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