EN Official Journal of the European Union C 102/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2017 to 28 February 2017

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

(2017/C 102/01)

— 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 13.2.2017 LIFMIOR etanercept Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/16/1165 Powder and solvent for solution for injection L04AB01 15.2.2017 13.2.2017 Olumiant baricitinib Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/1170 Film-coated tablet L04AA37 15.2.2017 13.2.2017 Vihuma simoctocog alfa Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige EU/1/16/1168 Powder and solvent for solution for injection B02BD02 15.2.2017 16.2.2017 Alecensa alectinib Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/16/1169 Capsule, hard L01XE36 20.2.2017 17.2.2017 Truxima rituximab Celltrion Healthcare Hungary Kft. 1051 Budapest Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország EU/1/16/1167 Concentrate for solution for infusion L01XC02 22.2.2017 27.2.2017 Pregabalin Zentiva k.s pregabalin Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1166 Capsule, hard N03AX16 1.3.2017

— 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 6.2.2017 Alimta Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/290 8.2.2017 6.2.2017 Amyvid Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/12/805 8.2.2017 6.2.2017 APTIVUS Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/05/315 8.2.2017 6.2.2017 Gardasil MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/357 8.2.2017 6.2.2017 Imvanex Bavarian Nordic A/S Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark EU/1/13/855 8.2.2017 6.2.2017 Scintimun CIS bio international Boîte postale 32, F-91192 Gif-sur-Yvette, France EU/1/09/602 8.2.2017 6.2.2017 Silgard Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358 8.2.2017 6.2.2017 Stribild Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/830 8.2.2017 6.2.2017 Tolucombi Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/13/821 9.2.2017 6.2.2017 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704 8.2.2017 8.2.2017 Optruma Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/98/074 10.2.2017 13.2.2017 Aripiprazole Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1009 15.2.2017 13.2.2017 Senshio Shionogi Limited 33 Kingsway, London WC2B 6UF, United Kingdom EU/1/14/978 15.2.2017 13.2.2017 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/99/110 15.2.2017 16.2.2017 Aripiprazole Sandoz Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/15/1029 20.2.2017 16.2.2017 Armisarte Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/15/1063 20.2.2017 16.2.2017 Brimica Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/963 20.2.2017 16.2.2017 Docetaxel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/611 20.2.2017 16.2.2017 Duaklir Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/964 20.2.2017 16.2.2017 Enyglid Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/580 20.2.2017 16.2.2017 EVOTAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1025 20.2.2017 16.2.2017 Farydak Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/1023 20.2.2017 16.2.2017 Forsteo Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/03/247 20.2.2017 16.2.2017 Genvoya Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/15/1061 20.2.2017 16.2.2017 INOmax Linde Healthcare AB SE-181 81 Lidingö, Sverige EU/1/01/194 22.2.2017 16.2.2017 Irbesartan/Hydrochlorothiazide Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/583 20.2.2017 16.2.2017 Kadcyla Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/885 20.2.2017 16.2.2017 Kalydeco Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/12/782 20.2.2017 16.2.2017 Leganto UCB Manufacturing Ireland Ltd Shannon Industrial Estate, Co, Clare, Ireland EU/1/11/695 20.2.2017 16.2.2017 Mirapexin Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/051 20.2.2017 16.2.2017 Neupro UCB Manufacturing Ireland Ltd Shannon Industrial Estate, Co, Clare, Ireland EU/1/05/331 20.2.2017 16.2.2017 Nimenrix Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/767 20.2.2017 16.2.2017 Nonafact Sanquin Plasma Products B.V. Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland EU/1/01/186 20.2.2017 16.2.2017 Nucala GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/15/1043 20.2.2017 16.2.2017 Optimark Mallinckrodt Deutschland GmbH Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland EU/1/07/398 20.2.2017 16.2.2017 Portrazza Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1084 20.2.2017 16.2.2017 Quinsair Horizon Pharma Europe B.V. Naritaweg 165, NL-1043 BW Amsterdam, Nederland EU/1/14/973 20.2.2017 16.2.2017 Ravicti Horizon Pharma Ireland Limited Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland EU/1/15/1062 20.2.2017 16.2.2017 Repaglinide Krka Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/579 20.2.2017 16.2.2017 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/391 20.2.2017 16.2.2017 Revolade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/612 20.2.2017 16.2.2017 Rivastigmine Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/11/693 20.2.2017 16.2.2017 Sifrol Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/050 20.2.2017 16.2.2017 Stocrin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/111 20.2.2017 16.2.2017 Twynsta Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/10/648 20.2.2017 16.2.2017 Viread Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/01/200 20.2.2017 16.2.2017 Zyprexa Velotab Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/99/125 20.2.2017 17.2.2017 Caprelsa Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/11/749 21.2.2017 17.2.2017 Cyramza Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/957 21.2.2017 17.2.2017 Emend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262 21.2.2017 17.2.2017 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/945 21.2.2017 17.2.2017 Pioglitazone Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/757 21.2.2017 17.2.2017 Pioglitazone Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/758 21.2.2017 17.2.2017 Repatha Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/1016 21.2.2017 23.2.2017 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/12/792 27.2.2017 23.2.2017 Daklinza Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/14/939 27.2.2017 23.2.2017 Docetaxel Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/769 27.2.2017 23.2.2017 Docetaxel Kabi Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom EU/1/12/770 27.2.2017 23.2.2017 Exviera AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/14/983 27.2.2017 23.2.2017 Harvoni Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/958 27.2.2017 23.2.2017 Ilaris Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/564 27.2.2017 23.2.2017 Ketoconazole HRA Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/14/965 27.2.2017 23.2.2017 Lamivudine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/566 27.2.2017 23.2.2017 OLYSIO Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/924 27.2.2017 23.2.2017 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/391 27.2.2017 23.2.2017 Sovaldi Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/894 27.2.2017 23.2.2017 Tivicay ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/13/892 27.2.2017 23.2.2017 Vargatef Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/954 27.2.2017 23.2.2017 Viekirax AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/14/982 27.2.2017 23.2.2017 Zinforo AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/785 27.2.2017 27.2.2017 Adcirca Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/08/476 1.3.2017 27.2.2017 Kisplyx Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/16/1128 1.3.2017 27.2.2017 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423 1.3.2017

— 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 2.2.2017 VarroMed oxalic acid dihydrate/formic acid BeeVital GmbH Wiesenbergstrasse 19, 5164, Seeham, Österreich EU/2/16/203 Bee-hive dispersion Pending 6.2.2017 9.2.2017 Stronghold Plus selamectin/sarolaner Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/16/204 Spot-on solution QP54AA55 13.2.2017

— 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 9.2.2017 EQUIOXX Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/08/083 13.2.2017 10.2.2017 Vectormune ND CEVA-Phylaxia Co. Ltd Budapest, Szállás u. 5, 1107 MAGYARORSZÁG EU/2/15/188 14.2.2017 17.2.2017 ERYSENG PARVO Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España EU/2/14/167 21.2.2017 17.2.2017 Trifexis Eli Lilly and Company Ltd, Elanco Animal Health Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/13/155 21.2.2017 17.2.2017 Vectra 3D CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/13/156 21.2.2017 27.2.2017 Equip WNV Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/08/086 1.3.2017

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.