Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2018 to 30 November 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 465/01)

— 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 14.11.2018 Emgality galcanezumab Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/18/1330 Solution for injection N02CX08 16.11.2018 20.11.2018 Apealea paclitaxel Oasmia Pharmaceutical AB Vallongatan 1, 75228 Uppsala, Sverige EU/1/18/1292 Powder for solution for infusion L01CD01 22.11.2018 20.11.2018 Buvidal buprenorphine Camurus AB Ideon Science Park, 223 70 Lund, Sverige EU/1/18/1336 Prolonged-release solution for injection N07BC01 22.11.2018 20.11.2018 Fulphila pegfilgrastim Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1329 Solution for injection L03AA13 22.11.2018 20.11.2018 Pelmeg pegfilgrastim Cinfa Biotech S.L. Travesía de Roncesvalles 1, 31699 Olloki (Navarra), España EU/1/18/1328 Solution for injection L03AA13 22.11.2018 20.11.2018 Vabomere meropenem/vaborbactam Rempex London Limited 115L Milton Park, Abingdon, Oxfordshire, OX14 4SA United Kingdom EU/1/18/1334 Powder for concentrate for solution for infusion J01DH52 22.11.2018 20.11.2018 Venclyxto venetoclax AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/16/1138 Film-coated tablet L01XX52 22.11.2018 22.11.2018 Alunbrig brigatinib Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/18/1264 Film-coated tablet L01XE43 26.11.2018 22.11.2018 Delstrigo doravirine/lamivudine/tenofovir disoproxil Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1333 Film-coated tablet J05AG24 26.11.2018 22.11.2018 Jivi damoctocog alfa pegol Bayer AG D-51368 Leverkusen, Deutschland EU/1/18/1324 Powder and solvent for solution for injection B02BD02 26.11.2018 22.11.2018 Luxturna voretigene neparvovec Spark Therapeutics Ireland Ltd Studio G3,The Tower, Trinity Technology & Enterprise Campus, Pearse Street, Dublin 2, Ireland EU/1/18/1331 Concentrate and solvent for solution for injection Pending 5.12.2018 22.11.2018 Pifeltro doravirine Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1332 Film-coated tablet J05AG06 27.11.2018 22.11.2018 Poteligeo Mogamulizumab Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/18/1335 Concentrate for solution for infusion L01XC25 26.11.2018 22.11.2018 TAKHZYRO lanadelumab Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, IRELAND EU/1/18/1340 Solution for injection B06AC05 26.11.2018 22.11.2018 Ziextenzo pegfilgrastim Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1327 Solution for injection L03AA13 26.11.2018

— 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 8.11.2018 Benepali Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/15/1074 13.11.2018 8.11.2018 Benepali Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/15/1074 15.11.2018 8.11.2018 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/17/1210 12.11.2018 8.11.2018 Flixabi Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/16/1106 15.11.2018 8.11.2018 Irbesartan HCT Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/06/377 12.11.2018 8.11.2018 Neupro UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/05/331 12.11.2018 8.11.2018 Ontruzant Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/17/1241 16.11.2018 8.11.2018 Ruconest Pharming Group N.V. Darwinweg 24, 2333 CR Leiden, Nederland EU/1/10/641 12.11.2018 8.11.2018 Spinraza Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/17/1188 12.11.2018 8.11.2018 Tracleer Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/02/220 12.11.2018 8.11.2018 Xeljanz Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/17/1178 12.11.2018 12.11.2018 Bemfola Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/13/909 14.11.2018 12.11.2018 CABOMETYX Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/16/1136 14.11.2018 12.11.2018 Clopidogrel ratiopharm Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/975 14.11.2018 12.11.2018 Desloratadine ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/11/746 14.11.2018 12.11.2018 Ebymect AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1051 14.11.2018 12.11.2018 Edistride AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1052 14.11.2018 12.11.2018 Exviera AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/983 14.11.2018 12.11.2018 Forxiga AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/795 14.11.2018 12.11.2018 Jinarc Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland EU/1/15/1000 14.11.2018 12.11.2018 Laventair Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/899 14.11.2018 12.11.2018 Olanzapine Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/08/475 7.12.2018 12.11.2018 Xigduo AstraZeneca AB 151 85 Södertälje, Sverige EU/1/13/900 14.11.2018 14.11.2018 Benlysta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/11/700 16.11.2018 14.11.2018 Daptomycin Hospira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom EU/1/17/1175 16.11.2018 14.11.2018 Incruse Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/922 16.11.2018 14.11.2018 Izba Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/905 16.11.2018 14.11.2018 Latuda Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.p.A. Viale Amelia 70, 00181 Roma, Italia EU/1/14/913 16.11.2018 14.11.2018 Laventair Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/899 16.11.2018 14.11.2018 Tecfidera Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/13/837 16.11.2018 20.11.2018 Brineura BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/17/1192 22.11.2018 20.11.2018 Brintellix H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/13/891 22.11.2018 20.11.2018 Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/16/1151 22.11.2018 20.11.2018 Fluenz Tetra AstraZeneca AB 151 85 Södertälje, Sverige EU/1/13/887 22.11.2018 20.11.2018 Incruse Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/922 22.11.2018 20.11.2018 Levetiracetam Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/13/889 22.11.2018 20.11.2018 Neuraceq Life Radiopharma Berlin GmbH Max-Planck-Straße 4, 12489 Berlin, Deutschland EU/1/13/906 22.11.2018 20.11.2018 NovoSeven Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/96/006 22.11.2018 20.11.2018 Orfadin Swedish Orphan Biovitrum International AB 112 76 Stockholm, Sverige EU/1/04/303 23.11.2018 20.11.2018 Ozurdex Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/10/638 22.11.2018 20.11.2018 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/06/380 22.11.2018 20.11.2018 Rapiscan GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge EU/1/10/643 22.11.2018 20.11.2018 Rezolsta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/967 22.11.2018 20.11.2018 Selincro H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/12/815 22.11.2018 20.11.2018 Symtuza Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/17/1225 22.11.2018 20.11.2018 Zoledronic acid Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/834 22.11.2018 22.11.2018 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430 26.11.2018 22.11.2018 Bexsero GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 26.11.2018 22.11.2018 Docetaxel Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/07/384 26.11.2018 22.11.2018 Efient Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/08/503 26.11.2018 22.11.2018 Erivedge Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/13/848 26.11.2018 22.11.2018 GILENYA Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/11/677 28.11.2018 22.11.2018 Inlyta Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/12/777 26.11.2018 22.11.2018 Ixiaro Valneva Austria GmbH Campus Vienna Biocenter 3, 1030 Wien, Österreich EU/1/08/501 26.11.2018 22.11.2018 Kalydeco Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/12/782 26.11.2018 22.11.2018 Kentera Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/03/270 26.11.2018 22.11.2018 Kyprolis Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1060 26.11.2018 22.11.2018 Levetiracetam Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/13/889 26.11.2018 22.11.2018 Mirvaso Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France EU/1/13/904 26.11.2018 22.11.2018 Nyxoid Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland EU/1/17/1238 26.11.2018 22.11.2018 Ranexa Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/462 26.11.2018 22.11.2018 Soliris Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France EU/1/07/393 27.11.2018 22.11.2018 Synflorix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/09/508 26.11.2018 22.11.2018 Viekirax AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/982 26.11.2018 22.11.2018 Wakix Bioprojet Pharma 9 rue Rameau, 75002 Paris, France EU/1/15/1068 26.11.2018 22.11.2018 Zinforo Pfizer Ireland Pharmaceuticals Operations Support Group, Ringaskiddy, County Cork, Ireland EU/1/12/785 26.11.2018 26.11.2018 alli GlaxoSmithKline Dungarvan Limited Knockbrack, Dungarvan, Co. Waterford, Ireland EU/1/07/401 29.11.2018 26.11.2018 Anoro Ellipta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/898 28.11.2018 26.11.2018 Darunavir Krka d.d. Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1248 28.11.2018 26.11.2018 Docetaxel Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/07/384 28.11.2018 26.11.2018 Kalydeco Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/12/782 28.11.2018 26.11.2018 Leflunomide ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/10/654 28.11.2018 26.11.2018 Orkambi Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/15/1059 28.11.2018 26.11.2018 PHEBURANE Eurocept International BV Trapgans 5, 1244 RL Ankeveen, Nederland EU/1/13/822 28.11.2018 26.11.2018 Zeffix GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/99/114 28.11.2018 28.11.2018 AMGEVITA Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1164 30.11.2018 28.11.2018 Pregabalin Zentiva k.s Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1166 30.11.2018

— 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 12.11.2018 Eperzan GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/13/908 14.11.2018

— 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 19.11.2018 Osurnia Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/14/170 21.11.2018 19.11.2018 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/07/078 21.11.2018 26.11.2018 Econor Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/98/010 28.11.2018 26.11.2018 Inflacam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/11/134 29.11.2018

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.