EN Official Journal of the European Union C 30/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2017 to 31 December 2017

(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 030/01)

— 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 8.12.2017 Tacforius tacrolimus Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/17/1244 Prolonged release capsule, hard L04AD02 12.12.2017 18.12.2017 Alecensa alectinib Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/16/1169 Capsule, hard L01XE36 20.12.2017

— 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 8.12.2017 Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech XBiotech Germany GmbH Lyoner Straße 14, 60528 Frankfurt am Main, Deutschland — 12.12.2017 18.12.2017 Masipro AB Science 3 avenue George V, 75008 Paris, France — 20.12.2017

— 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 1.12.2017 Alecensa Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/16/1169 5.12.2017 1.12.2017 Hetlioz Vanda Pharmaceuticals Limited 25 Old Broad Street, level 21a, London EC2N 1HQ, United Kingdom EU/1/15/1008 5.12.2017 1.12.2017 Jakavi Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/773 5.12.2017 1.12.2017 OCALIVA Intercept Pharma Ltd 2 Pancras Square, London N1C 4AG, United Kingdom EU/1/16/1139 5.12.2017 1.12.2017 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498 5.12.2017 8.12.2017 Ceplene Noventia Pharma Srl Via Carlo Pisacane 31, 47121 Forli, Italia EU/1/08/477 12.12.2017 8.12.2017 Dexdor Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/11/718 12.12.2017 8.12.2017 Esbriet Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/11/667 13.12.2017 8.12.2017 Esmya Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/12/750 12.12.2017 8.12.2017 Genvoya Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/15/1061 12.12.2017 8.12.2017 GILENYA Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/677 13.12.2017 8.12.2017 Humira AbbVie Ltd Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom EU/1/03/256 12.12.2017 8.12.2017 Januvia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383 13.12.2017 8.12.2017 JETREA ThromboGenics NV Gaston Geenslaan 1, 3001 Leuven, België EU/1/13/819 12.12.2017 8.12.2017 KEYTRUDA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1024 13.12.2017 8.12.2017 Leganto UCB Manufacturing Ireland Ltd Shannon Industrial Estate, Co, Clare, Ireland EU/1/11/695 12.12.2017 8.12.2017 Lemtrada Genzyme Therapeutics Ltd 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom EU/1/13/869 13.12.2017 8.12.2017 Moventig Kyowa Kirin Limited Galabank Business Park, Galashiels, TD1 1QH, United Kingdom EU/1/14/962 12.12.2017 8.12.2017 Mysimba Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/14/988 12.12.2017 8.12.2017 Oncaspar Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/15/1070 14.12.2017 8.12.2017 Perjeta Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/813 13.12.2017 8.12.2017 Selincro H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/12/815 12.12.2017 8.12.2017 Taltz Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1085 12.12.2017 8.12.2017 Tesavel Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435 13.12.2017 8.12.2017 Truberzi Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland EU/1/16/1126 12.12.2017 8.12.2017 Xiapex Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/11/671 12.12.2017 8.12.2017 Zevalin Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland EU/1/03/264 12.12.2017 11.12.2017 EVOTAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1025 13.12.2017 11.12.2017 Holoclar Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/987 13.12.2017 11.12.2017 Neupro UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/05/331 13.12.2017 11.12.2017 Odefsey Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/16/1112 13.12.2017 11.12.2017 Rapiscan GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge EU/1/10/643 15.12.2017 11.12.2017 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267 13.12.2017 11.12.2017 Strensiq Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France EU/1/15/1015 13.12.2017 11.12.2017 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311 13.12.2017 11.12.2017 Zyclara Meda AB Pipers väg 2A, 170 73 Solna, Sverige EU/1/12/783 13.12.2017 15.12.2017 Actelsar HCT Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/13/817 19.12.2017 15.12.2017 ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/794 19.12.2017 15.12.2017 Efficib Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457 19.12.2017 15.12.2017 Eviplera Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/11/737 19.12.2017 15.12.2017 Janumet Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455 19.12.2017 15.12.2017 M-M-RVAXPRO MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/337 19.12.2017 15.12.2017 Procysbi Chiesi Orphan B.V. Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland EU/1/13/861 19.12.2017 15.12.2017 Ristaben Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621 19.12.2017 15.12.2017 Ristfor Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620 19.12.2017 15.12.2017 Stocrin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/111 19.12.2017 15.12.2017 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/99/110 19.12.2017 15.12.2017 Velmetia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456 19.12.2017 18.12.2017 Daklinza Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/14/939 20.12.2017 18.12.2017 Enbrel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/126 20.12.2017 18.12.2017 HBVAXPRO MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/01/183 20.12.2017 18.12.2017 NovoMix Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/00/142 20.12.2017 18.12.2017 ProQuad MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/05/323 20.12.2017 18.12.2017 Xelevia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382 20.12.2017 20.12.2017 Azilect Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/04/304 22.12.2017 20.12.2017 Duloxetine Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/972 22.12.2017 20.12.2017 Ebymect AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1051 22.12.2017 20.12.2017 Efient Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/08/503 22.12.2017 20.12.2017 Fabrazyme Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland EU/1/01/188 22.12.2017 20.12.2017 Gardasil MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/357 22.12.2017 20.12.2017 Incresync Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/13/842 20.12.2017 20.12.2017 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/06/368 2.1.2018 20.12.2017 Levetiracetam ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/11/702 22.12.2017 20.12.2017 Levetiracetam SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/11/741 22.12.2017 20.12.2017 Qtern AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1108 22.12.2017 20.12.2017 Ranexa Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/462 22.12.2017 20.12.2017 Tivicay ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/13/892 22.12.2017 20.12.2017 Xigduo AstraZeneca AB 151 85 Södertälje, Sverige EU/1/13/900 22.12.2017

— 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 1.12.2017 Rabitec Rabies vaccine (live, oral) for foxes and raccoon dogs IDT Biologika GmbH Am Pharmapark, 06861 Dessau-Rosslau, Deutschland EU/2/17/219 Oral suspension QI07BD 5.12.2017

— 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 6.12.2017 Kexxtone Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/12/145 8.12.2017 6.12.2017 Spironolactone Ceva Ceva Santé Animale 10 avenue de la Ballastière, 33500 Libourne, France EU/2/07/074 8.12.2017 18.12.2017 Sedadex Le Vet Beheer B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/16/198 20.12.2017 20.12.2017 Easotic VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France EU/2/08/085 22.12.2017 20.12.2017 Leucogen Virbac 1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France EU/2/09/096 22.12.2017

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.