Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2018 to 30 September 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 433/01)

— 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 19.7.2018 Carmustine Obvius carmustine Obvius Investment B.V. De Cuserstraat 93, 1081 CN Amsterdam, Nederland EU/1/18/1278 Powder and solvent for concentrate for solution for infusion L01AD01 23.7.2018

— 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 20.9.2018 Dexxience Portola Pharma UK Limited 209 Tower Bridge Business Centre, 46-48 East Smithfield, London E1W 1AW, United Kingdom — 16.10.2018

— 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 30.1.2018 Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1133 1.2.2018 8.5.2018 Riluzole Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/12/768 15.5.2018 19.7.2018 Taxespira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom EU/1/15/1017 23.7.2018 26.7.2018 Defitelio Gentium S.r.I. Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia EU/1/13/878 30.7.2018 26.7.2018 Mycamine Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/08/448 30.7.2018 26.7.2018 Roteas Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/16/1152 30.9.2018 26.7.2018 Xeljanz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/17/1178 30.7.2018 30.7.2018 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118 9.8.2018

— 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 1.2.2018 Oxybee oxalic acid dihydrate Dany Bienenwohl GmbH Geyerspergerstraße 27, 80689 München, Deutschland EU/2/17/216 Powder and solution for bee-hive dispersion QP53AG03 5.2.2018

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.