EN Official Journal of the European Union C 252/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 2015

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

(2015/C 252/01)

— 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 10.6.2015 Gardasil 9 Human papillomavirus 9-valent vaccine (recombinant, adsorbed) Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/15/1007 Suspension for injection J07BM03 12.6.2015 19.6.2015 Duloxetine Mylan Duloxetine Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/15/1010 Gastro-resistant capsule, hard N06AX21 24.6.2015 19.6.2015 Lixiana Edoxaban Daiichi Sankyo Europe GmbH Zielstattstrasse 48, 81379 Munich, Deutschland EU/1/15/993 Film-coated tablet B01 23.6.2015 19.6.2015 Lumark Lutetium, isotope of mass 177 IDB Radiopharmacy B.V. Weverstraat 17, 5111 PV Baarle-Nassau, Nederland EU/1/15/1013 Radiopharmaceutical precursor, solution Pending 23.6.2015 19.6.2015 Opdivo Nivolumab Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 Concentrate for solution for infusion L01XC17 24.6.2015 19.6.2015 Pregabalin Sandoz Pregabalin Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/15/1011 Capsule, hard N03AX16 23.6.2015 19.6.2015 Pregabalin Sandoz GmbH Pregabalin Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/15/1012 Capsule, hard N03AX16 23.6.2015 25.6.2015 Aripiprazole Zentiva Aripiprazole Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1009 Orodispersible tablet Tablet N05AX12 29.6.2015 25.6.2015 Pregabalin Mylan Pregabalin Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/15/997 Capsule, hard N03AX16 30.6.2015 25.6.2015 Pregabalin Mylan Pharma Pregabalin Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/15/998 Capsule, hard N03AX16 29.6.2015 30.6.2015 Aripiprazole Pharmathen Aripiprazole Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/15/1005 Tablet N05AX12 2.7.2015

— 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 2.6.2015 Mirvaso Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France EU/1/13/904 4.6.2015 2.6.2015 Optimark Mallinckrodt Deutschland GmbH Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland EU/1/07/398 5.6.2015 5.6.2015 Kolbam Retrophin Europe Limited 25/28 North Wall Quay, Dublin 1, Ireland EU/1/13/895 9.6.2015 5.6.2015 Xelevia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382 9.6.2015 10.6.2015 CANCIDAS Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/01/196 12.6.2015 10.6.2015 Clopidogrel Krka d.d. Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/562 12.6.2015 10.6.2015 Tesavel Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435 12.6.2015 11.6.2015 Adjupanrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/578 16.6.2015 11.6.2015 IKERVIS Santen Oy Niittyhaankatu 20, FI-33720 Tampere, Suomi EU/1/15/990 15.6.2015 11.6.2015 Insulatard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/233 15.6.2015 11.6.2015 Pramipexole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/728 12.6.2015 11.6.2015 Protaphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/234 15.6.2015 16.6.2015 Clopidogrel HCS HCS bvba H. Kennisstraat 53, B-2650 Edegem, België EU/1/10/651 18.6.2015 19.6.2015 Actos Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/00/150 23.6.2015 19.6.2015 Actrapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/230 23.6.2015 19.6.2015 APTIVUS Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/05/315 23.6.2015 19.6.2015 AUBAGIO Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/13/838 23.6.2015 19.6.2015 DuoTrav Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/06/338 24.6.2015 19.6.2015 Eperzan GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/13/908 23.6.2015 19.6.2015 Fabrazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/01/188 23.7.2015 19.6.2015 Glustin Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/00/151 23.6.2015 19.6.2015 Leflunomide ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/10/654 23.6.2015 19.6.2015 Orfadin Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige EU/1/04/303 23.6.2015 19.6.2015 Rasilamlo Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/686 24.6.2015 19.6.2015 Rasilez Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/405 24.6.2015 19.6.2015 SonoVue Bracco International B.V. Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland EU/1/01/177 23.6.2015 19.6.2015 Telmisartan Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/10/639 23.6.2015 19.6.2015 Tyverb Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/440 24.6.2015 19.6.2015 VPRIV Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/10/646 23.6.2015 19.6.2015 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698 23.6.2015 19.6.2015 Yondelis Pharma Mar S.A. Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España EU/1/07/417 23.6.2015 22.6.2015 Cyanokit SERB S.A. Avenue Louise 480, 1050 Brussels, Belgique EU/1/07/420 24.6.2015 22.6.2015 Fycompa Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/12/776 24.6.2015 22.6.2015 JEVTANA Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/11/676 24.6.2015 22.6.2015 Kivexa ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/04/298 24.6.2015 22.6.2015 Kuvan Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/08/481 24.6.2015 22.6.2015 Prevenar Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/00/167 25.6.2015 22.6.2015 Rasilez HCT Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/491 24.6.2015 22.6.2015 Simponi Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland EU/1/09/546 24.6.2015 22.6.2015 Stelara Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/494 24.6.2015 22.6.2015 Xolair Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/05/319 24.6.2015 22.6.2015 Xtandi Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/13/846 24.6.2015 25.6.2015 Ibandronic Acid Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/642 29.6.2015 25.6.2015 Xultophy Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/14/947 29.6.2015 30.6.2015 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618 2.7.2015

— 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 25.6.2015 Rasilamlo Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/686 29.6.2015

— 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 10.6.2015 Sileo Dexmedetomidine hydrochloride Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/2/15/181 Oromucosal gel QN05CM18 12.6.2015

— 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 5.6.2015 Bovilis BTV8 Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/10/106 9.6.2015 5.6.2015 Equisolon Le Vet B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/14/161 9.6.2015 5.6.2015 Recuvyra Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/11/127 9.6.2015 10.6.2015 Cerenia Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/06/062 12.6.2015 10.6.2015 Equilis Te Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/05/055 12.6.2015 10.6.2015 Kexxtone Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/12/145 12.6.2015 10.6.2015 Previcox Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/04/045 12.6.2015 11.6.2015 Prac-Tic Novartis Sanidad Animal S.L. Calle de la Marina, 206, E-08013 Barcelona, España EU/2/06/066 12.6.2015 19.6.2015 Profender Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/05/054 23.6.2015 30.6.2015 Rhiniseng Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España EU/2/10/109 2.7.2015

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency 30, Churchill Place, Canary Wharf UK — LONDON E14 5EU

(1) OJ L 136, 30.4.2004, p. 1.