EN Official Journal of the European Union C 115/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2018 to 28 February 2018

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

(2018/C 115/01)

— 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 8.2.2018 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka efavirenz/emtricitabine/tenofovir disoproxil Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1263 Film-coated tablet J05AR06 12.2.2018 8.2.2018 Ozempic semaglutide Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/17/1251 Solution for injection A10BJ06 12.2.2018 9.2.2018 Alkindi hydrocortisone Diurnal Ltd Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, United Kingdom EU/1/17/1260 Granules in capsules for opening H02AB09 13.2.2018 9.2.2018 Herzuma trastuzumab Celltrion Healthcare Hungary Kft. Bajcsy-Zsilinszky út 12., 4. em. 410, 1051 Budapest, Magyarország EU/1/17/1257 Powder for concentrate for solution for infusion L01XC03 13.2.2018 15.2.2018 Anagrelide Mylan anagrelide Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1256 Capsule, hard L01XX35 19.2.2018 19.2.2018 CRYSVITA Burosumab Kyowa Kirin Limited Galabank Business Park, Galashiels, TD1 1QH, United Kingdom EU/1/17/1262 Solution for injection M05BX 21.2.2018 23.2.2018 Hemlibra emicizumab Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/18/1271 Solution for injection B02BX06 27.2.2018

— 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 5.2.2018 Ebilfumin Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/14/915 7.2.2018 5.2.2018 Episalvan Amryt AG Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland EU/1/15/1069 8.2.2018 5.2.2018 NULOJIX Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/694 7.2.2018 5.2.2018 Pedea Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/04/284 8.2.2018 5.2.2018 Pregabalin Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1011 7.2.2018 5.2.2018 Pregabalin Sandoz GmbH Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1012 7.2.2018 5.2.2018 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/06/380 7.2.2018 5.2.2018 Truvada Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/04/305 7.2.2018 5.2.2018 Vedrop Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/09/533 8.2.2018 8.2.2018 Bosulif Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 12.2.2018 8.2.2018 Daptomycin Hospira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom EU/1/17/1175 12.2.2018 8.2.2018 Esbriet Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/11/667 12.2.2018 8.2.2018 Exforge Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/370 12.2.2018 8.2.2018 Iclusig Incyte Biosciences UK Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom EU/1/13/839 12.2.2018 8.2.2018 Methylthioninium chloride Proveblue Provepharm S.A.S. 22 rue Marc Donadille, 13013 Marseille, France EU/1/11/682 15.2.2018 8.2.2018 OLYSIO Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/924 12.2.2018 8.2.2018 Rezolsta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/967 12.2.2018 8.2.2018 Thalidomide Celgene Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/08/443 12.2.2018 8.2.2018 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/04/274 12.2.2018 8.2.2018 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704 12.2.2018 8.2.2018 Voriconazole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/835 12.2.2018 8.2.2018 Xtandi Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/13/846 12.2.2018 9.2.2018 Caprelsa Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland EU/1/11/749 13.2.2018 9.2.2018 Cymbalta Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/296 13.2.2018 9.2.2018 Cystadane Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/06/379 13.2.2018 9.2.2018 Entyvio Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/923 13.2.2018 9.2.2018 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 13.2.2018 9.2.2018 Neuraceq Piramal Imaging Limited Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom EU/1/13/906 13.2.2018 9.2.2018 Ventavis Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/255 13.2.2018 15.2.2018 Emselex Merus Labs Luxco II S.à R.L. 26-28, rue Edward Steichen, 2540 Luxembourg EU/1/04/294 19.2.2018 15.2.2018 Fosavance Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310 19.2.2018 15.2.2018 Vantavo Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572 19.2.2018 16.2.2018 Esmya Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/12/750 20.2.2018 19.2.2018 Adcirca Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/08/476 21.2.2018 19.2.2018 Aerivio Spiromax Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/16/1122 21.2.2018 19.2.2018 Airexar Spiromax Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/16/1123 21.2.2018 19.2.2018 Anoro Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/898 21.2.2018 19.2.2018 Gardasil 9 MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/15/1007 21.2.2018 19.2.2018 Icandra Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/484 21.2.2018 19.2.2018 Lyrica Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/04/279 21.2.2018 19.2.2018 Mycamine Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/08/448 21.2.2018 19.2.2018 Neulasta Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/02/227 21.2.2018 19.2.2018 Nucala GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/15/1043 21.2.2018 19.2.2018 Olanzapine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/427 21.2.2018 19.2.2018 Ongentys Bial — Portela & Ca, SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal EU/1/15/1066 22.2.2018 19.2.2018 Orkambi Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/15/1059 21.2.2018 19.2.2018 PegIntron Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/131 21.2.2018 19.2.2018 Rebetol Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/107 21.2.2018 19.2.2018 Senshio Shionogi Limited 33 Kingsway, London WC2B 6UF, United Kingdom EU/1/14/978 21.2.2018 19.2.2018 Simulect Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/98/084 21.2.2018 19.2.2018 Talmanco Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1153 21.2.2018 19.2.2018 Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1129 21.2.2018 19.2.2018 Vfend Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212 21.2.2018 19.2.2018 ViraferonPeg Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/132 21.2.2018 19.2.2018 Wilzin Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/04/286 21.2.2018 19.2.2018 Zyprexa Velotab Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/99/125 21.2.2018 22.2.2018 Dynastat Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/209 26.2.2018 22.2.2018 Eucreas Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/425 26.2.2018 22.2.2018 NutropinAq Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/00/164 26.2.2018 22.2.2018 Trulicity Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/956 26.2.2018 22.2.2018 Zurampic Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland EU/1/15/1080 26.2.2018 27.2.2018 Abasaglar Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/944 1.3.2018 27.2.2018 Omnitrope Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/06/332 1.3.2018

— 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 7.2.2018 Suvaxyn Circo Porcine circovirus vaccine (inactivated, recombinant) Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/223 Emulsion for injection QI09AA07 9.2.2018

— 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 20.2.2018 Advocate Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/03/039 22.2.2018 20.2.2018 Porcilis PCV Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/08/091 22.2.2018 20.2.2018 Porcilis PCV M Hyo Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/14/175 22.2.2018 20.2.2018 Vectormune ND CEVA-Phylaxia Co. Ltd. Szállás u. 5, 1107 Budapest, Magyarország EU/2/15/188 22.2.2018

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.