Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2018 to 30 June 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 266/01)

— 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 18.6.2018 Blincyto blinatumomab Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1047 Powder for concentrate for solution for infusion L01XC19 20.6.2018 21.6.2018 Biktarvy bictegravir / emtricitabine / tenofovir alafenamide Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/18/1289 Film-coated tablet J05AR20 25.6.2018 25.6.2018 Dzuveo sufentanil FGK Representative Service GmbH Heimeranstraße 35, 80339 München, Deutschland EU/1/18/1284 Sublingual tablet N01AH03 27.6.2018

— 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 4.6.2018 Copalia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/372 6.6.2018 4.6.2018 Emtriva Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/03/261 6.6.2018 4.6.2018 Iclusig Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/13/839 6.6.2018 4.6.2018 Prolia Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/10/618 6.6.2018 4.6.2018 Stocrin Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/99/111 6.6.2018 4.6.2018 Stribild Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/830 6.6.2018 4.6.2018 Truvada Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/04/305 6.6.2018 4.6.2018 Tybost Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/872 6.6.2018 4.6.2018 Zinbryta Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/16/1107 6.6.2018 7.6.2018 ALPROLIX Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/16/1098 11.6.2018 7.6.2018 BeneFIX Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/97/047 11.6.2018 7.6.2018 Bexsero GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 11.6.2018 7.6.2018 Cerdelga Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland EU/1/14/974 11.6.2018 7.6.2018 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 11.6.2018 7.6.2018 Constella Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland EU/1/12/801 11.6.2018 7.6.2018 Dafiro Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/371 11.6.2018 7.6.2018 Exforge HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/569 11.6.2018 7.6.2018 Genvoya Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/15/1061 11.6.2018 7.6.2018 Harvoni Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/14/958 11.6.2018 7.6.2018 Isentress Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/436 11.6.2018 7.6.2018 Pemetrexed Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1071 11.6.2018 7.6.2018 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/08/442 11.6.2018 7.6.2018 Quinsair Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/973 11.6.2018 7.6.2018 SomaKit TOC Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France EU/1/16/1141 11.6.2018 7.6.2018 TAGRISSO AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1086 11.6.2018 7.6.2018 Uptravi Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/15/1083 11.6.2018 7.6.2018 Viekirax AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/982 11.6.2018 7.6.2018 Vosevi Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/17/1223 11.6.2018 7.6.2018 Votubia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/11/710 11.6.2018 7.6.2018 Xultophy Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/14/947 11.6.2018 7.6.2018 Zydelig Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/14/938 11.6.2018 7.6.2018 Zykadia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/999 11.6.2018 12.6.2018 Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1133 14.6.2018 12.6.2018 Fareston Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/96/004 14.6.2018 12.6.2018 Incruse Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/922 14.6.2018 12.6.2018 Kuvan BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/08/481 14.6.2018 14.6.2018 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/97/030 19.6.2018 14.6.2018 Iscover Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/98/070 19.6.2018 14.6.2018 SOLYMBIC Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1163 19.6.2018 15.6.2018 Aerinaze Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/399 19.6.2018 15.6.2018 Lusduna Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/16/1162 19.6.2018 15.6.2018 Maviret AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/17/1213 19.6.2018 15.6.2018 Neoclarityn Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/161 19.6.2018 15.6.2018 Xyrem UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/05/312 19.6.2018 15.6.2018 Zepatier Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/16/1119 19.6.2018 15.6.2018 Zerbaxa Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1032 19.6.2018 15.6.2018 ZINPLAVA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/16/1156 19.6.2018 21.6.2018 Inflectra Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom EU/1/13/854 25.6.2018 21.6.2018 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 25.6.2018 21.6.2018 Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/10/637 25.6.2018 21.6.2018 Panretin Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/00/149 25.6.2018 21.6.2018 Remsima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/13/853 25.6.2018 21.6.2018 Rolufta GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/17/1174 25.6.2018 21.6.2018 Targretin Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/01/178 25.6.2018 21.6.2018 Xeljanz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/17/1178 25.6.2018 21.6.2018 Xofigo Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/873 25.6.2018 25.6.2018 Copalia HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/575 27.6.2018 25.6.2018 Cubicin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/328 27.6.2018 25.6.2018 Dafiro HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/574 27.6.2018 25.6.2018 Darzalex Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/16/1101 27.6.2018 25.6.2018 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1222 27.6.2018 25.6.2018 Exforge Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/370 27.6.2018 25.6.2018 Glivec Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/198 27.6.2018 25.6.2018 Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/09/604 27.6.2018 25.6.2018 Nexium Control Pfizer Consumer Healthcare Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/13/860 27.6.2018 25.6.2018 Orbactiv The Medicines Company UK Ltd 115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom EU/1/15/989 27.6.2018 25.6.2018 PANTOLOC Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/519 27.6.2018 25.6.2018 pantoprazole 26.6.2018 25.6.2018 Stivarga Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/858 27.6.2018 25.6.2018 Xeljanz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/17/1178 27.6.2018 25.6.2018 Xgeva Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/11/703 27.6.2018 25.6.2018 Yondelis Pharma Mar S.A. Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España EU/1/07/417 27.6.2018 29.6.2018 Aerius Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/00/160 3.7.2018 29.6.2018 Azomyr Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/00/157 3.7.2018 29.6.2018 Edistride AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1052 3.7.2018 29.6.2018 Efficib Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/457 3.7.2018 29.6.2018 Granupas Eurocept International B.V. Trapgans 5, 1244 RL Ankeveen, Nederland EU/1/13/896 3.7.2018 29.6.2018 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 3.7.2018 29.6.2018 Janumet Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/455 3.7.2018 29.6.2018 Jinarc Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/15/1000 3.7.2018 29.6.2018 Olumiant Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/1170 3.7.2018 29.6.2018 Orgalutran Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/130 3.7.2018 29.6.2018 Revlimid Celgene Europe B.V. Winthonlaan 6N, 3526 KV Utrecht, Nederland EU/1/07/391 3.7.2018 29.6.2018 Rezolsta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/967 3.7.2018 29.6.2018 Ristfor Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/10/620 3.7.2018 29.6.2018 Samsca Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/09/539 3.7.2018 29.6.2018 Spectrila medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/15/1072 3.7.2018 29.6.2018 Temozolomide Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/10/615 3.7.2018 29.6.2018 Velmetia Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/456 3.7.2018

— 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 15.6.2018 SOLYMBIC Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1163 19.6.2018 21.6.2018 Angiox The Medicines Company UK Ltd 115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom EU/1/04/289 25.6.2018 29.6.2018 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704 3.7.2018

— 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 14.6.2018 Dany's BienenWohl oxalic acid dihydrate Dany Bienenwohl GmbH Geyerspergerstraße 27, 80689 München, Deutschland EU/2/18/225 Powder and solution for bee-hive dispersion QP53AG03 19.6.2018

— 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 4.6.2018 Activyl Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/10/118 6.6.2018 4.6.2018 Cepedex CP-Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf, Deutschland EU/2/16/200 6.6.2018 11.6.2018 Veraflox Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/10/107 13.6.2018 14.6.2018 Aftovaxpur Doe Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/13/153 19.6.2018 18.6.2018 Rhiniseng Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/10/109 20.6.2018 27.6.2018 BROADLINE Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/13/157 29.6.2018 27.6.2018 Evalon Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/16/194 29.6.2018 27.6.2018 Porcilis PCV M Hyo Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/14/175 29.6.2018

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.