EN Official Journal of the European Union C 189/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016

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

(2016/C 189/01)

— 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 4.4.2016 Rasagiline Mylan rasagiline Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/16/1090 Tablet N04BD02 6.4.2016 8.4.2016 Palonosetron Hospira palonosetron Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/16/1100 Solution for injection A04AA05 12.4.2016 21.4.2016 Descovy emtricitabine/tenofovir alafenamide Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/16/1099 Film-coated tablet J05AR17 25.4.2016 25.4.2016 Lonsurf trifluridine/tipiracil Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes Cedex, France EU/1/16/1096 Film-coated tablet L01BC 27.4.2016 25.4.2016 Taltz ixekizumab Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1085 Solution for injection L04AC13 28.4.2016

— 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 4.4.2016 Gardasil 9 Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/15/1007 6.4.2016 4.4.2016 Humira AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/03/256 6.4.2016 4.4.2016 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 6.4.2016 4.4.2016 Revolade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/612 6.4.2016 4.4.2016 Telzir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/04/282 6.4.2016 4.4.2016 Xgeva Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/11/703 6.4.2016 7.4.2016 Dafiro HCT Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/574 11.4.2016 7.4.2016 Imprida Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/373 11.4.2016 7.4.2016 Ziagen ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/99/112 11.4.2016 8.4.2016 Entacapone Orion Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/708 12.4.2016 8.4.2016 INCRELEX Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/07/402 12.4.2016 8.4.2016 Zyprexa Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/96/022 12.4.2016 13.4.2016 Cholib BGP Products Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom EU/1/13/866 15.4.2016 13.4.2016 Ibandronic acid Sandoz Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/11/685 15.4.2016 13.4.2016 Ixiaro Valneva Austria GmbH Campus Vienna Biocenter 3, A-1030 Wien, Österreich EU/1/08/501 15.4.2016 13.4.2016 Jakavi Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/773 15.4.2016 13.4.2016 Nemdatine Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland EU/1/13/824 15.4.2016 13.4.2016 Paliperidone Janssen Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/971 15.4.2016 13.4.2016 Ryzodeg Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/806 15.4.2016 13.4.2016 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222 15.4.2016 13.4.2016 Tresiba Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/807 15.4.2016 13.4.2016 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423 15.4.2016 13.4.2016 Zypadhera Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/08/479 15.4.2016 18.4.2016 Exjade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/356 20.4.2016 18.4.2016 Tysabri Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/06/346 20.4.2016 21.4.2016 Abilify Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/04/276 25.4.2016 21.4.2016 Bonviva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/265 25.4.2016 21.4.2016 Dasselta Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/739 25.4.2016 21.4.2016 Desloratadine ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/11/746 25.4.2016 21.4.2016 Exviera AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/14/983 25.4.2016 21.4.2016 Helicobacter Test INFAI INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142, D-44799 Bochum, Deutschland EU/1/97/045 25.4.2016 21.4.2016 Nplate Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/08/497 25.4.2016 21.4.2016 Temozolomide SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/11/697 25.4.2016 21.4.2016 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698 25.4.2016 21.4.2016 Zoely Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/690 25.4.2016 25.4.2016 Bondronat Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/012 27.4.2016 25.4.2016 Competact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/354 27.4.2016 25.4.2016 Cubicin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/328 27.4.2016 25.4.2016 Invokana Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/884 27.4.2016 25.4.2016 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/930 27.4.2016 25.4.2016 Picato Leo Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark EU/1/12/796 27.4.2016 25.4.2016 Trizivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/00/156 27.4.2016 25.4.2016 Tysabri Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/06/346 27.4.2016 28.4.2016 ABILIFY MAINTENA Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/13/882 3.5.2016 28.4.2016 Forxiga AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/795 2.5.2016 28.4.2016 Levetiracetam ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/11/702 2.5.2016 28.4.2016 Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 2.5.2016 28.4.2016 Viekirax AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/14/982 3.5.2016 28.4.2016 Vokanamet Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/918 2.5.2016 28.4.2016 Xigduo AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/13/900 2.5.2016 28.4.2016 ZALTRAP Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/12/814 2.5.2016

— Issuing 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 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 18.4.2016 Evalon Coccidiosis vaccine live for chickens Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España EU/2/16/194 Suspension and solvent for oral spray QI01AN01 20.4.2016 20.4.2016 LETIFEND Recombinant Protein Q from L. infantum MON-1 Laboratorios LETI, S.L.unipersonal C/Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España EU/2/16/195 Lyophilisate and solvent for solution for injection QI07A 22.4.2016

— 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 4.4.2016 Meloxidolor Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/13/148 6.4.2016 12.4.2016 BTVPUR Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/10/113 14.4.2016 12.4.2016 Poulvac E. coli Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/140 14.4.2016 18.4.2016 CERTIFECT Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/11/125 20.4.2016 18.4.2016 Clomicalm Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/98/007 20.4.2016 18.4.2016 ECOPORC SHIGA IDT Biologika GmbH Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland EU/2/13/149 20.4.2016 18.4.2016 Pexion Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/2/12/147 20.4.2016 18.4.2016 Profender Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/05/054 20.4.2016 18.4.2016 Zulvac 1 Bovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/130 20.4.2016 18.4.2016 Zulvac 1 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/131 20.4.2016 20.4.2016 Aftovaxpur Doe Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/153 22.4.2016 20.4.2016 Oncept IL-2 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/150 22.4.2016 27.4.2016 Draxxin Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/03/041 29.4.2016 27.4.2016 Naxcel Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/05/053 29.4.2016

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.