EN Official Journal of the European Union C 367/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2017 to 30 September 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 367/01)

— 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 5.9.2017 Cuprior trientine gmp-orphan SA Pépinière Paris Santé Cochin, 27-29 rue Faubourg Saint-Jacques, 75014 Paris, France EU/1/17/1199 Tablet A16AX12 7.9.2017 5.9.2017 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Efavirenz/emtricitabine/tenofovir disoproxil Mylan S.A.S. 117 Allée des Parcs, 69800 Saint-Priest, France EU/1/17/1222 Film-coated tablet J05AR06 7.9.2017 18.9.2017 Bavencio avelumab Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/17/1214 Concentrate for solution for infusion Pending 20.9.2017 18.9.2017 Entecavir Mylan entecavir Mylan S.A.S. 117 Allée des Parcs, 69800 Saint-Priest, France EU/1/17/1227 Film-coated tablet J05AF10 20.9.2017 18.9.2017 Lacosamide Accord lacosamide Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/17/1230 Film-coated tablet N03AX18 20.9.2017 18.9.2017 Rydapt Midostaurin Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/17/1218 Capsule, soft L01XE39 20.9.2017 18.9.2017 Xermelo telotristat Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/17/1224 Film-coated tablet Pending 20.9.2017 21.9.2017 Symtuza darunavir/cobicistat/emtricitabine/tenofovir alafenamide Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/17/1225 Film-coated tablet Pending 25.9.2017 21.9.2017 Tecentriq atezolizumab Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/17/1220 Concentrate for solution for infusion Pending 25.9.2017 26.9.2017 Dupixent dupilumab Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/17/1229 Solution for injection Pending 28.9.2017 26.9.2017 Entecavir Accord entecavir Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/17/1211 Film-coated tablet J05AF10 28.9.2017 26.9.2017 Lutathera lutetium (177Lu) oxodotreotide Advanced Accelerator Applications 20 rue Diesel, F-01630 Saint-Genis-Pouilly, France EU/1/17/1226 Solution for infusion V10XX04 28.9.2017

— 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 5.9.2017 Humira AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/03/256 7.9.2017 5.9.2017 Olazax Glenmark Pharmaceuticals s.r.o. Hvězdova 1716/2b, 140 78 Praha 4, Česká republika. EU/1/09/597 7.9.2017 5.9.2017 Thorinane Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Nederland EU/1/16/1131 7.9.2017 7.9.2017 Binocrit Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/07/410 11.9.2017 7.9.2017 Epoetin alfa Hexal Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/07/411 11.9.2017 7.9.2017 Fexeric Keryx Biopharma UK Ltd. Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom EU/1/15/1039 11.9.2017 7.9.2017 Intanza Sanofi Pasteur Europe 2 Avenue Pont Pasteur, 69007 Lyon, France EU/1/08/505 11.9.2017 7.9.2017 Taltz Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1085 11.9.2017 11.9.2017 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/00/152 13.9.2017 11.9.2017 Januvia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383 13.9.2017 11.9.2017 Jinarc Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/15/1000 13.9.2017 11.9.2017 Methylthioninium chloride Proveblue Provepharm S.A.S. 22 Rue Marc Donadille, 13013 Marseille, France EU/1/11/682 14.9.2017 11.9.2017 Neparvis Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/16/1103 13.9.2017 11.9.2017 Osseor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/04/287 13.9.2017 11.9.2017 Protelos Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/04/288 13.9.2017 11.9.2017 Simponi Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland EU/1/09/546 13.9.2017 11.9.2017 Tesavel Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435 13.9.2017 11.9.2017 Tysabri Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/06/346 13.9.2017 11.9.2017 Ventavis Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/255 13.9.2017 11.9.2017 Votrient Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/628 13.9.2017 11.9.2017 Xelevia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382 13.9.2017 11.9.2017 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/96/009 13.9.2017 11.9.2017 Zyprexa Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/96/022 13.9.2017 14.9.2017 Angiox The Medicines Company UK Ltd 115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom EU/1/04/289 18.9.2017 14.9.2017 Ebixa H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/02/219 18.9.2017 14.9.2017 Eurartesim Alfasigma S.p.A. Viale Sarca, n. 223, 20126 Milano, Italia EU/1/11/716 21.9.2017 14.9.2017 Glidipion Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/12/756 18.9.2017 14.9.2017 Ifirmasta Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/480 18.9.2017 14.9.2017 Olanzapine Apotex Apotex Europe B.V. Darwinweg 20, NL-2333 CR Leiden, Nederland EU/1/10/635 18.9.2017 14.9.2017 Olazax Disperzi Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika EU/1/09/592 18.9.2017 14.9.2017 Sovaldi Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/894 18.9.2017 14.9.2017 Trevicta Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/971 18.9.2017 14.9.2017 Vimpat UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/08/470 18.9.2017 14.9.2017 Wakix Bioprojet Pharma 9 rue Rameau, F-75002 Paris, France EU/1/15/1068 18.9.2017 18.9.2017 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland EU/1/07/412 20.9.2017 18.9.2017 Betmiga Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/12/809 20.9.2017 18.9.2017 Bexsero GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 20.9.2017 18.9.2017 Blincyto Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/1047 20.9.2017 18.9.2017 Gazyvaro Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/14/937 20.9.2017 18.9.2017 Ibandronic acid Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/798 20.9.2017 18.9.2017 Imatinib Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/808 20.9.2017 18.9.2017 Lumark IDB Holland B.V. Weverstraat 17, 5111 PV Baarle-Nassau, Nederland EU/1/15/1013 20.9.2017 18.9.2017 Lynparza AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/959 20.9.2017 18.9.2017 Lyxumia Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/12/811 20.9.2017 18.9.2017 Mozobil Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/09/537 20.9.2017 18.9.2017 NexoBrid MediWound Germany GmbH Eisenstr. 5, D-65428 Ruesselsheim, Deutschland EU/1/12/803 20.9.2017 18.9.2017 Ninlaro Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/16/1094 20.9.2017 18.9.2017 Nivestim Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/10/631 20.9.2017 18.9.2017 NovoRapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/99/119 20.9.2017 18.9.2017 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 20.9.2017 18.9.2017 Oslif Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/586 20.9.2017 18.9.2017 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618 20.9.2017 18.9.2017 Retacrit Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/07/431 20.9.2017 18.9.2017 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/391 20.9.2017 18.9.2017 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492 20.9.2017 18.9.2017 RotaTeq MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/348 20.9.2017 18.9.2017 Samsca Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/09/539 21.9.2017 18.9.2017 Signifor Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/753 20.9.2017 18.9.2017 Xgeva Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/11/703 20.9.2017 18.9.2017 Zebinix Bial — Portela & Ca, SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal EU/1/09/514 28.7.2017 18.9.2017 Zebinix Bial — Portela & Ca, SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal EU/1/09/514 20.9.2017 18.9.2017 Zypadhera Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/08/479 20.9.2017 21.9.2017 Amyvid Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/12/805 25.9.2017 21.9.2017 EndolucinBeta ITG Isotope Technologies Garching GmbH Lichtenbergstr. 1, D-85748 Garching, Deutschland EU/1/16/1105 25.9.2017 21.9.2017 Iclusig Incyte Biosciences UK Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom EU/1/13/839 25.9.2017 21.9.2017 Lartruvo Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/1143 25.9.2017 21.9.2017 Lenvima Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/15/1002 25.9.2017 21.9.2017 Plenadren Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/715 25.9.2017 21.9.2017 Relvar Ellipta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/13/886 25.9.2017 21.9.2017 Revinty Ellipta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/929 25.9.2017 21.9.2017 Ryzodeg Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/806 25.9.2017 21.9.2017 Tresiba Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/807 25.9.2017 21.9.2017 Xtandi Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/13/846 25.9.2017 21.9.2017 ZALTRAP Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/12/814 25.9.2017 26.9.2017 Hirobriz Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/594 28.9.2017 26.9.2017 Onbrez Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/593 28.9.2017 26.9.2017 Ristempa Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/996 28.9.2017 26.9.2017 Stayveer Marklas Nederland B.V. Beneluxlaan 2b, NL-3446 GR Woerden, Nederland EU/1/13/832 28.9.2017 26.9.2017 TachoSil Takeda Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich EU/1/04/277 28.9.2017 26.9.2017 Tracleer Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220 28.9.2017 26.9.2017 Xoterna Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/863 28.9.2017 28.9.2017 Neupro UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/05/331 2.10.2017 28.9.2017 Revolade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/612 29.9.2017

— 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 28.9.2017 Ristempa Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/996 2.10.2017

— 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 7.9.2017 SevoFlo Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/02/035 11.9.2017 14.9.2017 Equilis Te Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/05/055 18.9.2017 14.9.2017 LETIFEND Laboratorios LETI, S.L.unipersonal C/Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España EU/2/16/195 18.9.2017 14.9.2017 Nobivac Myxo-RHD Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/11/132 18.9.2017 14.9.2017 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/07/078 19.9.2017 21.9.2017 Bovalto Ibraxion Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/99/017 25.9.2017 21.9.2017 Pirsue Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/00/027 25.9.2017 21.9.2017 Sevohale Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/16/196 25.9.2017 25.9.2017 Equilis Prequenza Te Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/05/057 27.9.2017 25.9.2017 Metacam Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/97/004 27.9.2017 28.9.2017 ProZinc Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/2/13/152 2.10.2017 28.9.2017 Versican Plus L4 Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/171 2.10.2017 28.9.2017 Versican Plus Pi Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/168 2.10.2017 28.9.2017 Versican Plus Pi/L4 Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/172 2.10.2017

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.