EN Official Journal of the European Union C 61/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2017 to 31 January 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 061/01)

— 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 4.1.2017 AFSTYLA lonoctocog alfa CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/16/1158 Powder and solvent for solution for injection B02BD02 6.1.2017 4.1.2017 Darunavir Mylan darunavir Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/16/1140 Film-coated tablet J05AE10 6.1.2017 4.1.2017 Lusduna insulin glargine Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/16/1162 Solution for injection A10AE04 6.1.2017 4.1.2017 Terrosa teriparatide Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország EU/1/16/1159 Solution for injection H05AA02 6.1.2017 9.1.2017 Fiasp insulin aspart Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/16/1160 Solution for injection A10AB05 11.1.2017 9.1.2017 Tadalafil Generics tadalafil Mylan S.A.S. 117 Allée des Parcs, 69800 Saint-Priest, France EU/1/16/1153 Film-coated tablet G04BE08 11.1.2017 9.1.2017 Vemlidy tenofovir alafenamide Gilead Sciences International Ltd. Cambridge, CB21 6GT, United Kingdom EU/1/16/1154 Film-coated tablet J05AF13 11.1.2017 11.1.2017 Movymia teriparatide STADA Arzneimittel AG Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland EU/1/16/1161 Solution for injection H05AA02 13.1.2017 11.1.2017 Suliqua insulin glargine/lixisenatide Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/16/1157 Solution for injection A10AE54 13.1.2017 18.1.2017 ZINPLAVA bezlotoxumab Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/16/1156 Concentrate for solution for infusion J06BB21 20.1.2017 19.1.2017 Cystadrops mercaptamine Orphan Europe SARL Immeuble ‘Le Wilson’, 70, Avenue du Général de Gaulle, 92800 Puteaux, France EU/1/15/1049 Eye drops, solution S01XA21 23.1.2017

— 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 4.1.2017 Emadine Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/98/095 6.1.2017 4.1.2017 Imatinib Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/845 6.1.2017 4.1.2017 Incruse Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/922 6.1.2017 4.1.2017 Kolbam Retrophin Europe Limited Palmerstown House, Fenian Street, Dublin 2, Ireland EU/1/13/895 6.1.2017 4.1.2017 Vepacel Nanotherapeutics Bohumil, s.r.o. Bohumil 138, 28163 Jevany, Česká republika EU/1/12/752 6.1.2017 4.1.2017 Zonegran Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/04/307 6.1.2017 9.1.2017 Capecitabine Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/762 11.1.2017 9.1.2017 Capecitabine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/761 11.1.2017 9.1.2017 DaTSCAN GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom EU/1/00/135 11.1.2017 9.1.2017 Foclivia Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/09/577 11.1.2017 9.1.2017 Naglazyme BioMarin Europe Ltd. 10 Bloomsbury Way, London WC1A 2SL, United Kingdom EU/1/05/324 13.1.2017 9.1.2017 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/979 11.1.2017 9.1.2017 Relistor PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika EU/1/08/463 11.1.2017 9.1.2017 Riluzole Zentiva Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France EU/1/12/768 11.1.2017 9.1.2017 SANCUSO Kyowa Kirin Limited Galabank Business Park, Galashiels, TD1 1QH, United Kingdom EU/1/12/766 11.1.2017 9.1.2017 Translarna PTC Therapeutics International Limited 77 Sir John Rogerson’s Quay, Dublin 2, Ireland EU/1/13/902 11.1.2017 9.1.2017 Viagra Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/98/077 11.1.2017 9.1.2017 Viramune Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/055 11.1.2017 9.1.2017 Xultophy Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/14/947 11.1.2017 11.1.2017 Adenuric Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/447 13.1.2017 11.1.2017 Brintellix H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/13/891 13.1.2017 11.1.2017 Bronchitol Pharmaxis Pharmaceuticals Limited 25 Moorgate, London, EC2R 6AY, United Kingdom. EU/1/12/760 13.1.2017 11.1.2017 Cometriq Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/13/890 13.1.2017 11.1.2017 Defitelio Gentium S.r.l Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia EU/1/13/878 16.1.2017 11.1.2017 Entresto Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/1058 13.1.2017 11.1.2017 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145 13.1.2017 11.1.2017 Imatinib Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/845 13.1.2017 11.1.2017 Inovelon Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/06/378 13.1.2017 11.1.2017 Invanz Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/02/216 13.1.2017 11.1.2017 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437 13.1.2017 11.1.2017 Kuvan BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/08/481 13.1.2017 11.1.2017 Pregabalin Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/15/997 13.1.2017 11.1.2017 Pregabalin Mylan Pharma Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/15/998 13.1.2017 11.1.2017 Ruconest Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland EU/1/10/641 13.1.2017 11.1.2017 Vimizim BioMarin Europe Ltd. 10 Bloomsbury Way, London WC1A 2SL, United Kingdom EU/1/14/914 13.1.2017 11.1.2017 Xadago Zambon S.p.A. Via Lillo del Duca 10, 20 091 Bresso (MI), Italia EU/1/14/984 13.1.2017 19.1.2017 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/930 23.1.2017 23.1.2017 Lymphoseek Norgine B.V. Hogehilweg 7, 1101CA Amsterdam, Nederland EU/1/14/955 25.1.2017 23.1.2017 Remsima Celltrion Healthcare Hungary Kft. Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország EU/1/13/853 25.1.2017 26.1.2017 Cinryze Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/688 30.1.2017 26.1.2017 Iclusig Incyte Biosciences UK Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom EU/1/13/839 30.1.2017 26.1.2017 NovoSeven Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/96/006 30.1.2017 26.1.2017 Orfadin Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige EU/1/04/303 30.1.2017 26.1.2017 Picato LEO Laboratories Ltd. 285 Cashel Road, Crumlin, Dublin 12, Ireland EU/1/12/796 30.1.2017 26.1.2017 Rezolsta Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/967 30.1.2017 26.1.2017 Voriconazole Hikma Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal EU/1/15/1004 30.1.2017 27.1.2017 Ameluz Biofrontera Bioscience GmbH Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland EU/1/11/740 31.1.2017 27.1.2017 Benepali Samsung Bioepis UK Limited 3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom EU/1/15/1074 31.1.2017 27.1.2017 Docetaxel Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/769 31.1.2017 27.1.2017 Jentadueto Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/12/780 31.1.2017 27.1.2017 KEYTRUDA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1024 31.1.2017 27.1.2017 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 31.1.2017 27.1.2017 Stivarga Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/13/858 31.1.2017 27.1.2017 Trajenta Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/11/707 31.1.2017 27.1.2017 Vaxelis MCM Vaccine B.V. Robert Boyleweg 4, 2333 CG Leiden, Nederland EU/1/15/1079 31.1.2017 27.1.2017 Votubia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/710 31.1.2017 27.1.2017 Xydalba Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland EU/1/14/986 31.1.2017

— Withdrawal of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 9.1.2017 Vylaer Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/949 11.1.2017 18.1.2017 Clopidogrel Acino Acino AG Am Windfeld 35, 83714 D-Miesbach, Deutschland EU/1/09/532 20.1.2017

— 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 9.1.2017 Coliprotec F4/F18 Porcine post-weaning diarrhoea vaccine (live) Prevtec Microbia GmbH Geyerspergerstr 27, 80689 München, Deutschland EU/2/16/202 Lyophilisate for oral suspension QI09AE03 11.1.2017

— 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 9.1.2017 Novaquin Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/15/186 11.1.2017 18.1.2017 Nobilis IB 4-91 Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/98/006 20.1.2017 18.1.2017 Simparica Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/15/191 20.1.2017

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.