EN Official Journal of the European Union C 70/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2018 to 31 January 2018

(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 070/01)

— 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 8.1.2018 ADYNOVI rurioctocog alfa pegol Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/17/1247 Powder and solvent for solution for injection B02BD02 10.1.2018 8.1.2018 Fasenra benralizumab AstraZeneca AB 151 85 Södertälje, Sverige EU/1/17/1252 Solution for injection R03DX10 10.1.2018 8.1.2018 Fulvestrant Mylan fulvestrant Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1253 Solution for injection L02BA03 10.1.2018 8.1.2018 Intrarosa prasterone Endoceutics Ltd. Salisbury house, London Wall, London, EC2M 5PS, United Kingdom EU/1/17/1255 Pessary QM01AX92 6.2.2018 8.1.2018 Jorveza budesonide Dr Falk Pharma GmbH Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland EU/1/17/1254 Orodispersible tablet A07EA06 10.1.2018 8.1.2018 Ocrevus ocrelizumab Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/17/1231 Concentrate for solution for infusion L04AA36 10.1.2018 8.1.2018 PREVYMIS letermovir Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/17/1245 Concentrate for solution for infusion Film-coated tablet J05AX18 10.1.2018 15.1.2018 Mvasi bevacizumab Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/17/1246 Concentrate for solution for infusion L01XC07 17.1.2018 18.1.2018 Darunavir Krka d.d. darunavir Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1248 Film-coated tablet J05AE10 22.1.2018 26.1.2018 Darunavir Krka darunavir Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1249 Film-coated tablet J05AE10 30.1.2018

— Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 8.1.2018 Onzeald Nektar Therapeutics UK Limited Elizabeth House, 13-19 Queen Street, Leeds LS1 2TW, United Kingdom — 10.1.2018 15.1.2018 Fanaptum Vanda Pharmaceuticals Limited 222 Regent Street, London W1B 5TR, United Kingdom — 19.1.2018

— 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 8.1.2018 Bronchitol Pharmaxis Pharmaceuticals Limited 25 Moorgate, London, EC2R 6AY, United Kingdom EU/1/12/760 10.1.2018 8.1.2018 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 10.1.2018 8.1.2018 Cometriq Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/13/890 10.1.2018 8.1.2018 Comtess Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/98/082 10.1.2018 8.1.2018 Hexacima Sanofi Pasteur SA 2 avenue Pont Pasteur, 69007 Lyon, France EU/1/13/828 10.1.2018 8.1.2018 Hexyon Sanofi Pasteur Europe 2 avenue Pont Pasteur, 69007 Lyon, France EU/1/13/829 10.1.2018 8.1.2018 HyQvia Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/13/840 10.1.2018 8.1.2018 Imatinib Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/13/825 10.1.2018 8.1.2018 Ixiaro Valneva Austria GmbH Campus Vienna Biocenter 3, 1030 Wien, Österreich EU/1/08/501 10.1.2018 8.1.2018 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/930 10.1.2018 8.1.2018 Memantine LEK Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/13/826 10.1.2018 8.1.2018 Memantine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/13/827 15.1.2018 8.1.2018 Nemdatine Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/13/824 10.1.2018 8.1.2018 Orkambi Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/15/1059 10.1.2018 8.1.2018 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/08/442 10.1.2018 8.1.2018 Stayveer Marklas Nederland B.V. Beneluxlaan 2b, 3446 GR Woerden, Nederland EU/1/13/832 10.1.2018 8.1.2018 Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 10.1.2018 8.1.2018 Tolucombi Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/13/821 10.1.2018 8.1.2018 Votrient Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/628 10.1.2018 8.1.2018 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698 10.1.2018 8.1.2018 Zinbryta Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/16/1107 10.1.2018 8.1.2018 Zonegran Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/04/307 10.1.2018 11.1.2018 Carbaglu Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/02/246 15.1.2018 11.1.2018 Cinacalcet Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1054 15.1.2018 11.1.2018 Cystadrops Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/15/1049 15.1.2018 11.1.2018 Cystagon Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/97/039 15.1.2018 11.1.2018 Lartruvo Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/1143 15.1.2018 11.1.2018 Laventair Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/899 15.1.2018 11.1.2018 Levetiracetam Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/701 15.1.2018 11.1.2018 OLYSIO Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/924 15.1.2018 15.1.2018 Adasuve Ferrer Internacional S.A. Gran Via Carlos III, 94 08028 Barcelona, España EU/1/13/823 17.1.2018 15.1.2018 Ciambra Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg EU/1/15/1055 17.1.2018 15.1.2018 Prialt Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/04/302 17.1.2018 15.1.2018 Zostavax MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/341 17.1.2018 18.1.2018 Bortezomib Hospira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom EU/1/16/1114 22.1.2018 18.1.2018 Leganto UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/11/695 22.1.2018 18.1.2018 Marixino Consilient Health Ltd 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland EU/1/13/820 22.1.2018 18.1.2018 Omidria Omeros London Limited Berkeley Square, London, W1J 6BD, United Kingdom EU/1/15/1018 22.1.2018 18.1.2018 Taltz Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1085 22.1.2018 18.1.2018 Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1127 22.1.2018 18.1.2018 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 22.1.2018 18.1.2018 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698 22.1.2018 24.1.2018 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419 26.1.2018 24.1.2018 DUAVIVE Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/14/960 26.1.2018 24.1.2018 IBRANCE Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/16/1147 26.1.2018 24.1.2018 LeukoScan Immunomedics GmbH Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland EU/1/97/032 26.1.2018 25.1.2018 Matever Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/11/711 29.1.2018 26.1.2018 Cerdelga Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland EU/1/14/974 30.1.2018 26.1.2018 Mysimba Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/14/988 30.1.2018 30.1.2018 Cialis Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/02/237 31.1.2018 30.1.2018 Colobreathe Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/747 1.2.2018 30.1.2018 Copalia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/372 1.2.2018 30.1.2018 Copalia HCT Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/575 1.2.2018 30.1.2018 Cresemba Basilea Medical Ltd c/o Cox Costello & Horne Limited, Langwood House, 63-81 High Street, Rickmansworth, Hertfordshire WD3 1EQ, United Kingdom EU/1/15/1036 1.2.2018 30.1.2018 Dafiro Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/371 1.2.2018 30.1.2018 Dafiro HCT Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/574 1.2.2018 30.1.2018 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1222 1.2.2018 30.1.2018 Effentora Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/441 1.2.2018 30.1.2018 Exforge HCT Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/569 1.2.2018 30.1.2018 Fycompa Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/12/776 1.2.2018 30.1.2018 Granpidam Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/16/1137 1.2.2018 30.1.2018 Hizentra CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/11/687 1.2.2018 30.1.2018 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437 1.2.2018 30.1.2018 Nplate Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/08/497 1.2.2018 30.1.2018 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/05/330 1.2.2018 30.1.2018 Stelara Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/08/494 2.2.2018 30.1.2018 Vectibix Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/07/423 1.2.2018

— 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 11.1.2018 Daliresp AstraZeneca AB 151 85 Södertälje, Sverige EU/1/11/668 15.1.2018 11.1.2018 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/06/368 15.1.2018 11.1.2018 Libertek AstraZeneca AB 151 85 Södertälje, Sverige EU/1/11/666 15.1.2018 18.1.2018 Zoledronic acid Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/772 22.1.2018 30.1.2018 LeukoScan Immunomedics GmbH Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland EU/1/97/032 1.2.2018

— 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 9.1.2018 GALLIPRANT grapiprant Aratana Therapeutics NV Ambachtenlaan 1, 3001 Heverlee, België EU/2/17/221 Tablet QM01AX92 11.1.2018 31.1.2018 MiPet Easecto sarolaner Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/220 Chewable tablet QP53BE03 2.2.2018

— 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 9.1.2018 Cortavance VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France EU/2/06/069 11.1.2018 9.1.2018 Ypozane VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France EU/2/06/068 11.1.2018 12.1.2018 Aftovaxpur Doe Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/13/153 16.1.2018 12.1.2018 Leucofeligen FeLV/RCP Virbac 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France EU/2/09/097 16.1.2018 12.1.2018 Virbagen Omega VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France EU/2/01/030 16.1.2018 12.1.2018 Zactran Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/08/082 16.1.2018 16.1.2018 Semintra Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/12/146 18.1.2018 31.1.2018 Meloxoral Le Vet B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/10/111 2.2.2018

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.