EN Official Journal of the European Union C 171/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2017 to 30 April 2017

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

(2017/C 171/01)

— 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 10.4.2017 Chenodeoxycholic acid sigma-tau chenodeoxycholic acid sigma-tau Arzeimittel GmbH Liebherrstr. 22, 80538 München, Deutschland EU/1/16/1110 Capsule, hard A05AA01 12.4.2017 20.4.2017 Roteas edoxaban Daiichi Sankyo Europe GmbH Zielstattstrasse 48, D-81379 München, Deutschland EU/1/16/1152 Film-coated tablet B01AF03 24.4.2017 20.4.2017 Varuby rolapitant TESARO UK LIMITED 55 Baker Street, London W1U 7EU, United Kingdom EU/1/17/1180 Film-coated tablet A04AD14 24.4.2017 24.4.2017 Natpar parathyroid hormone Shire Pharmaceuticals Ireland Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/15/1078 Powder and solution for injection H05AA03 26.4.2017 24.4.2017 Pemetrexed Hospira UK Limited pemetrexed Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/17/1183 Powder for concentrate for solution for infusion L01BA04 26.4.2017 24.4.2017 TAGRISSO osimertinib AstraZeneca AB Gärtunavägen, SE-151 85 Södertälje, Sverige EU/1/16/1086 Film-coated tablet L01XE35 26.4.2017 28.4.2017 Darzalex daratumumab Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/16/1101 Concentrate for solution for infusion L01XC24 3.5.2017 28.4.2017 Emtricitabine/Tenofovir disoproxil Krka d.d. emtricitabine/tenofovir disoproxil KRKA, d.d. Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1182 Film-coated tablet J05AR03 3.5.2017

— 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 3.4.2017 Clopidogrel Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/08/465 5.4.2017 3.4.2017 Corlentor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/317 5.4.2017 3.4.2017 DuoPlavin Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/10/619 5.4.2017 3.4.2017 JEVTANA Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/11/676 5.4.2017 3.4.2017 Procoralan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/316 5.4.2017 3.4.2017 Vepacel Nanotherapeutics UK Limited 10 Chiswell Street, 2nd Floor London, EC1Y 4UQ, United Kingdom EU/1/12/752 5.4.2017 3.4.2017 Xofigo Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/873 5.4.2017 6.4.2017 Evra Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/02/223 10.4.2017 6.4.2017 Fycompa Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/12/776 10.4.2017 6.4.2017 Irbesartan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/576 10.4.2017 6.4.2017 Levetiracetam Hospira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/13/889 10.4.2017 6.4.2017 Vivanza Bayer AG D-51368 Leverkusen, Deutschland EU/1/03/249 10.4.2017 6.4.2017 Zalviso Grünenthal GmbH Zieglerstrasse 6, D-52078, Aachen, Deutschland EU/1/15/1042 10.4.2017 11.4.2017 Abasaglar Eli Lilly Regional Operations GmbH. Kölblgasse 8-10, 1030 Wien, Österreich EU/1/14/944 13.4.2017 11.4.2017 Constella Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland EU/1/12/801 13.4.2017 11.4.2017 Envarsus Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/935 13.4.2017 11.4.2017 Helixate NexGen Bayer AG D-51368 Leverkusen, Deutschland EU/1/00/144 13.4.2017 11.4.2017 Hexacima Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France EU/1/13/828 13.4.2017 11.4.2017 Iblias Bayer AG D-51368 Leverkusen, Deutschland EU/1/15/1077 13.4.2017 11.4.2017 KOGENATE Bayer Bayer AG D-51368 Leverkusen, Deutschland EU/1/00/143 13.4.2017 11.4.2017 Kovaltry Bayer AG D-51368 Leverkusen, Deutschland EU/1/15/1076 13.4.2017 11.4.2017 Optimark Guerbet 15, rue des Vanesses, 93420, Villepinte, France EU/1/07/398 13.4.2017 11.4.2017 Orgalutran Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/130 13.4.2017 11.4.2017 Sylvant Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/928 13.4.2017 12.4.2017 Eylea Bayer AG D-51368 Leverkusen, Deutschland EU/1/12/797 19.4.2017 12.4.2017 Myfenax Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/438 19.4.2017 12.4.2017 Ovaleap Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/13/871 19.4.2017 12.4.2017 Tecfidera Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/13/837 19.4.2017 20.4.2017 Bretaris Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/781 24.4.2017 20.4.2017 Briviact UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/15/1073 24.4.2017 20.4.2017 Cetrotide Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/99/100 25.4.2017 20.4.2017 Edistride AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/15/1052 24.4.2017 20.4.2017 Eklira Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/778 24.4.2017 20.4.2017 Forxiga AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/795 24.4.2017 20.4.2017 Glybera uniQure biopharma B.V. Meibergdreef 61, NL-1105 BA Amsterdam, Nederland EU/1/12/791 24.4.2017 20.4.2017 Invokana Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/884 24.4.2017 20.4.2017 Izba Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/905 24.4.2017 20.4.2017 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/930 24.4.2017 20.4.2017 Lonquex UAB ‘Sicor Biotech’ Molėtų pl. 5, LT-08409 Vilnius, Lietuva EU/1/13/856 24.4.2017 20.4.2017 Mycophenolate mofetil Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/439 24.4.2017 20.4.2017 Pandemic influenza vaccine H5N1 MedImmune MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland EU/1/16/1089 24.4.2017 20.4.2017 Picato LEO Laboratories Ltd. 285 Cashel Road, Crumlin, Dublin 12, Ireland EU/1/12/796 24.4.2017 20.4.2017 Rotarix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/05/330 24.4.2017 20.4.2017 Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 24.4.2017 20.4.2017 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222 24.4.2017 20.4.2017 Travatan Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/01/199 24.4.2017 20.4.2017 Vokanamet Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/918 24.4.2017 20.4.2017 Xigduo AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/13/900 24.4.2017 24.4.2017 CANCIDAS Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/01/196 26.4.2017 24.4.2017 Darzalex Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/16/1101 26.4.2017 24.4.2017 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France EU/1/07/384 26.4.2017 24.4.2017 Esbriet Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/11/667 26.4.2017 24.4.2017 Flebogamma DIF Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa EU/1/07/404 26.4.2017 24.4.2017 Imatinib Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/13/825 26.4.2017 24.4.2017 Jakavi Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/773 26.4.2017 24.4.2017 Opatanol Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/02/217 26.4.2017 24.4.2017 Siklos Addmedica 101 rue Saint Lazare, F-75009 Paris, France EU/1/07/397 26.4.2017 24.4.2017 Zinforo AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/785 26.4.2017 28.4.2017 Actos Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/00/150 3.5.2017 28.4.2017 Cholestagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/268 3.5.2017 28.4.2017 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 4.5.2017 28.4.2017 Cinqaero Teva Pharmaceuticals Limited Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom EU/1/16/1125 3.5.2017 28.4.2017 CONTROLOC Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/515 3.5.2017 28.4.2017 Fertavid Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/510 3.5.2017 28.4.2017 Glustin Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/00/151 3.5.2017 28.4.2017 Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/13/876 3.5.2017 28.4.2017 Invokana Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/884 3.5.2017 28.4.2017 Ixiaro Valneva Austria GmbH Campus Vienna Biocenter 3, A-1030 Wien, Österreich EU/1/08/501 3.5.2017 28.4.2017 Kalydeco Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/12/782 3.5.2017 28.4.2017 NovoNorm Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/98/076 3.5.2017 28.4.2017 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 3.5.2017 28.4.2017 PANTOLOC Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/519 3.5.2017 28.4.2017 PANTOZOL Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/517 3.5.2017 28.4.2017 Prandin Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/00/162 3.5.2017 28.4.2017 Puregon Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/008 3.5.2017 28.4.2017 Repaglinide Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/530 3.5.2017 28.4.2017 SOMAC Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/516 3.5.2017 28.4.2017 Temozolomide Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/606 3.5.2017 28.4.2017 Tresiba Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/807 3.5.2017 28.4.2017 Trobalt Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/681 3.5.2017 28.4.2017 Vizarsin Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/551 3.5.2017 28.4.2017 Vokanamet Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/918 3.5.2017 28.4.2017 Xeplion Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/672 3.5.2017 28.4.2017 Zebinix Bial-Portela & Ca, SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal EU/1/09/514 3.5.2017 28.4.2017 Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/12/779 3.5.2017

— Withdrawal of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 3.4.2017 Imprida Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/373 5.4.2017 24.4.2017 DUTREBIS Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/995 26.4.2017

— 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 25.4.2017 Credelio lotilaner Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/17/206 Chewable tablet QP53BE04 27.4.2017 25.4.2017 CYTOPOINT lokivetmab Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/205 solution for injection in a vial QD11AH91 27.4.2017 25.4.2017 Zulvac BTV Ovis Bluetongue vaccine (inactivated): serotype 1, 4, 8 Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/207 Suspension for injection QI04AA02 27.4.2017

— 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 11.4.2017 Procox Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/11/123 19.4.2017 12.4.2017 FORTEKOR PLUS Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/15/185 19.4.2017 25.4.2017 Cerenia Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/06/062 27.4.2017 25.4.2017 Quadrisol VETCOOL B.V. Otto Hahnweg 24, 3542 AX Utrecht, Nederland EU/2/97/005 28.4.2017

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.