Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2018 to 31 October 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 433/02)

— 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 31.10.2018 Symkevi tezacaftor/ivacaftor Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/18/1306 Film-coated tablet R07AX31 6.11.2018

— 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 4.10.2018 Exviera AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/983 8.10.2018 4.10.2018 Grastofil Apotex Europe B.V. Archimedesweg 2, 2333 CN Leiden, Nederland EU/1/13/877 8.10.2018 4.10.2018 Palonosetron Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/16/1100 8.10.2018 10.10.2018 Irbesartan Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/06/376 12.10.2018 10.10.2018 Kalydeco Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/12/782 12.10.2018 11.10.2018 Riximyo Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1184 15.10.2018 16.10.2018 ABILIFY MAINTENA Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland EU/1/13/882 18.10.2018 16.10.2018 Kivexa ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/04/298 18.10.2018 16.10.2018 Leflunomide Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/09/604 18.10.2018 16.10.2018 Rapamune Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/01/171 18.10.2018 16.10.2018 Sutent Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/06/347 18.10.2018 18.10.2018 Evoltra Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland EU/1/06/334 22.10.2018 18.10.2018 Forsteo Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/03/247 22.10.2018 18.10.2018 Irbesartan/Hydrochlorothiazide Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/583 22.10.2018 18.10.2018 Pemetrexed Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/15/1057 22.10.2018 18.10.2018 Velphoro Vifor Fresenius Medical Care Renal Pharma France 100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France EU/1/14/943 22.10.2018 23.10.2018 Cosentyx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/980 25.10.2018 23.10.2018 Micardis Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/98/090 25.10.2018 23.10.2018 XALKORI Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/12/793 25.10.2018 23.10.2018 Xtandi Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/13/846 25.10.2018 23.10.2018 Zinbryta Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/16/1107 25.10.2018 25.10.2018 Clopidogrel/Acetylsalicylic acid Zentiva Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/10/623 29.10.2018 25.10.2018 Clopidogrel Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/08/465 29.10.2018 25.10.2018 Cyltezo Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/17/1240 29.10.2018 25.10.2018 DuoPlavin Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France EU/1/10/619 29.10.2018 25.10.2018 Iscover Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/98/070 29.10.2018 25.10.2018 Plavix Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France EU/1/98/069 29.10.2018 25.10.2018 Replagal Shire Human Genetic Therapies AB Vasagatan 7, 111 20 Stockholm, Sverige EU/1/01/189 29.10.2018 25.10.2018 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/99/110 29.10.2018 25.10.2018 Synflorix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/09/508 29.10.2018 29.10.2018 AMGEVITA Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1164 31.10.2018 29.10.2018 Evista Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/98/073 31.10.2018 29.10.2018 Imraldi Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/17/1216 31.10.2018 29.10.2018 Integrilin GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/99/109 31.10.2018 29.10.2018 Protopic Leo Pharma A/S Industriparken 55, 2750 Ballerup, Danmark EU/1/02/201 1.11.2018 29.10.2018 RoActemra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/08/492 31.10.2018 29.10.2018 Taxespira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom EU/1/15/1017 31.10.2018 29.10.2018 Venclyxto AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/16/1138 31.10.2018 29.10.2018 Volibris GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/08/451 31.10.2018 31.10.2018 Arzerra Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/10/625 6.11.2018 31.10.2018 Elebrato Ellipta GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/17/1237 6.11.2018 31.10.2018 Neulasta Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/02/227 6.11.2018 31.10.2018 Samsca Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland EU/1/09/539 6.11.2018 31.10.2018 Trelegy Ellipta GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/17/1236 6.11.2018

— 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 29.10.2018 Lusduna Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/16/1162 31.10.2018 30.10.2018 Taxespira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom EU/1/15/1017 1.11.2018

— 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 17.10.2018 Recocam Bimeda Animal Health Limited 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland EU/2/11/133 19.10.2018 18.10.2018 NexGard Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/13/159 22.10.2018 18.10.2018 NEXGARD SPECTRA Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/14/177 22.10.2018 23.10.2018 Canigen L4 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/15/183 25.10.2018 30.10.2018 Dexdomitor Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/2/02/033 1.11.2018 30.10.2018 Improvac Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/095 5.11.2018 30.10.2018 Zolvix Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/09/101 1.11.2018

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.