Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2018 to 31 December 2018

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

(2019/C 32/01)

— 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 12.12.2018 Dengvaxia dengue tetravalent vaccine (live, attenuated) Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/18/1338 Powder and solvent for suspension for injection J07BX 14.12.2018 12.12.2018 Flucelvax Tetra influenza vaccine (surface antigen, inactivated, prepared in cell cultures) Seqirus Netherlands B.V. Hullenbergweg 89 1101 CL Amsterdam, Nederland EU/1/18/1326 Suspension for injection J07BB02 14.12.2018 12.12.2018 Ogivri trastuzumab Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1341 Powder for concentrate for solution for infusion L01XC03 14.12.2018 18.12.2018 Bevespi Aerosphere glycopyrronium bromide / formoterol AstraZeneca AB 151 85 Södertälje, Sverige EU/1/18/1339 Pressurised inhalation, suspension R03AL07 20.12.2018 18.12.2018 Namuscla Mexiletine Lupin Europe GmbH Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland EU/1/18/1325 Capsule, hard C01BB02 20.12.2018

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

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 6.12.2018 Exondys AVI BioPharma International Ltd Tower Bridge House, St Katharine’s Way, London E1W 1DD, United Kingdom — 10.12.2018

— 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 6.12.2018 Anoro Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/898 10.12.2018 6.12.2018 Avamys GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/07/434 10.12.2018 6.12.2018 Darunavir Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1140 10.12.2018 7.12.2018 Elocta Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/15/1046 12.12.2018 7.12.2018 EVOTAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1025 12.12.2018 7.12.2018 Onivyde Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/16/1130 11.12.2018 7.12.2018 Rubraca Clovis Oncology Ireland Limited Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland EU/1/17/1250 11.12.2018 7.12.2018 Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1127 11.12.2018 7.12.2018 Toujeo Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133 11.12.2018 7.12.2018 Ucedane Eurocept International B.V. Trapgans 5, 1244 RL Ankeveen, Nederland EU/1/17/1202 11.12.2018 7.12.2018 Xermelo Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/17/1224 11.12.2018 7.12.2018 Ziagen ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/99/112 11.12.2018 10.12.2018 Daklinza Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/14/939 12.12.2018 10.12.2018 Darunavir Krka Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1249 12.12.2018 10.12.2018 Oncaspar Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/15/1070 12.12.2018 10.12.2018 Xolair Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/05/319 12.12.2018 12.12.2018 Desloratadine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/732 14.12.2018 12.12.2018 Entyvio Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/923 14.12.2018 12.12.2018 Evoltra Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/06/334 14.12.2018 12.12.2018 Kengrexal Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/15/994 14.12.2018 12.12.2018 Kevzara Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1196 14.12.2018 12.12.2018 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 14.12.2018 12.12.2018 Mimpara Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/04/292 14.12.2018 12.12.2018 Moventig Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/14/962 14.12.2018 12.12.2018 OCALIVA Intercept Pharma Ltd 2 Pancras Square, London N1C 4AG, United Kingdom EU/1/16/1139 17.12.2018 12.12.2018 Pandemic influenza vaccine H5N1 BAXTER Ology Bioservices Ireland LTD Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland EU/1/09/571 18.12.2018 12.12.2018 Praluent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/15/1031 14.12.2018 12.12.2018 Pregabalin Pfizer Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/14/916 14.12.2018 12.12.2018 Reagila Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/17/1209 14.12.2018 12.12.2018 Relvar Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/13/886 14.12.2018 12.12.2018 Revinty Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/929 14.12.2018 12.12.2018 RXULTI Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland EU/1/18/1294 14.12.2018 12.12.2018 Trevicta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/971 14.12.2018 12.12.2018 Triumeq ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/14/940 14.12.2018 12.12.2018 Valdoxan Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes CEDEX, France EU/1/08/499 14.12.2018 12.12.2018 Vfend Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/02/212 14.12.2018 17.12.2018 Dupixent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1229 19.12.2018 17.12.2018 Elaprase Shire Human Genetic Therapies AB Vasagatan 7, 111 20 Stockholm, Sverige EU/1/06/365 19.12.2018 17.12.2018 Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1133 19.12.2018 17.12.2018 Epivir ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/96/015 19.12.2018 17.12.2018 Hexacima Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/13/828 19.12.2018 17.12.2018 Hexyon Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/13/829 19.12.2018 17.12.2018 Kisqali Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/17/1221 19.12.2018 17.12.2018 Zejula TESARO Bio Netherlands B.V. Joop Geeskinkweg, 901, 1114AB, Amsterdam-Duisvendrecht, Nederland EU/1/17/1235 19.12.2018 17.12.2018 Zubsolv Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland EU/1/17/1233 19.12.2018 18.12.2018 Alimta Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/290 19.12.2018 18.12.2018 Amyvid Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/12/805 20.12.2018 18.12.2018 Darzalex Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/16/1101 20.12.2018 18.12.2018 Granupas Eurocept International B.V. Trapgans 5, 1244 RL Ankeveen, Nederland EU/1/13/896 20.12.2018 18.12.2018 Ledaga Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15, Ireland EU/1/16/1171 20.12.2018 18.12.2018 Mabthera Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/98/067 20.12.2018 18.12.2018 Otezla Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/14/981 20.12.2018 18.12.2018 Ravicti Horizon Pharma Ireland Limited Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland EU/1/15/1062 20.12.2018 18.12.2018 Vectibix Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/07/423 20.12.2018 18.12.2018 Vokanamet Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/918 20.12.2018 20.12.2018 Panretin Eisai GmbH Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland EU/1/00/149 2.1.2019 20.12.2018 Vihuma Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige EU/1/16/1168 27.12.2018

— Withdrawal of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 6.12.2018 Ivabradine JensonR JensonR+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom EU/1/16/1145 10.12.2018 17.12.2018 Macugen PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c, 17000 Praha 7 Česká republika EU/1/05/325 19.12.2018

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

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 12.12.2018 LONGRANGE Merial 29 avenue Tony Garnier, 69007 Lyon, France — 14.12.2018

— 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 7.12.2018 Aivlosin ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom EU/2/04/044 11.12.2018 7.12.2018 Imrestor Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/15/193 11.12.2018 12.12.2018 Aftovaxpur Doe Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/13/153 14.12.2018 17.12.2018 Bovela Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/14/176 19.12.2018 17.12.2018 Coxevac Ceva Santé Animale 10 avenue de la Ballastière, 33500 Libourne, France EU/2/10/110 20.12.2018 17.12.2018 Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/07/079 19.12.2018 17.12.2018 Nobilis IB 4-91 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/98/006 19.12.2018 18.12.2018 Nobilis IB Primo QX Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/14/174 20.12.2018 19.12.2018 NexGard Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/13/159 21.12.2018

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.