Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2019 to 31 January 2019

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

(2019/C 80/01)

— 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 7.1.2019 Silodosin Recordati silodosin Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/18/1343 Capsule, hard G04CA04 9.1.2019 11.1.2019 Macimorelin Aeterna Zentaris macimorelin Æterna Zentaris GmbH Weismüllerstraße 50, 60314 Frankfurt am Main, Deutschland EU/1/18/1337 Granules for oral solution V04CD06 15.1.2019 14.1.2019 Erleada apalutamide Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/18/1342 Film-coated tablet L02BB05 16.1.2019

— 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 7.1.2019 Eladynos Radius International Ltd Liberty House, 222 Regent Street, W1B 5TR, London, United Kingdom — 23.1.2019

— 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 7.1.2019 Ivabradine Anpharm ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. ul. Annopol 6B, 03–236 Warszawa, Polska EU/1/15/1041 9.1.2019 7.1.2019 Omidria Omeros London Limited Berkeley Square House, Berkeley Square, London, W1J 6BD, United Kingdom EU/1/15/1018 9.1.2019 7.1.2019 Pregabalin Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1011 9.1.2019 7.1.2019 Pregabalin Sandoz GmbH Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1012 9.1.2019 7.1.2019 Strensiq Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France EU/1/15/1015 10.1.2019 7.1.2019 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498 9.1.2019 11.1.2019 Corlentor Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/05/317 15.1.2019 11.1.2019 Ebymect AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1051 16.1.2019 11.1.2019 Hemangiol Pierre Fabre Dermatologie 45 place Abel Gance, 92100 Boulogne, France EU/1/14/919 15.1.2019 11.1.2019 Hizentra CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/11/687 15.1.2019 11.1.2019 Imatinib Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/13/825 15.1.2019 11.1.2019 Incruse Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/922 15.1.2019 11.1.2019 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 15.1.2019 11.1.2019 Laventair Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/899 15.1.2019 11.1.2019 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 15.1.2019 11.1.2019 Orbactiv Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg EU/1/15/989 16.1.2019 11.1.2019 Ovaleap Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/13/871 16.1.2019 11.1.2019 Procoralan Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/05/316 15.1.2019 11.1.2019 Savene Clinigen Healthcare B.V. Schiphol Boulevard 359, WTC Schiphol Airport, D Tower 11th floor, 1118BJ Schiphol, The Netherlands EU/1/06/350 17.1.2019 11.1.2019 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/901 15.1.2019 11.1.2019 Symkevi Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/18/1306 15.1.2019 11.1.2019 Tamiflu Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/02/222 16.1.2019 11.1.2019 Vepacel Ology Bioservices Ireland LTD Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland EU/1/12/752 16.1.2019 11.1.2019 Vizamyl GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge EU/1/14/941 15.1.2019 11.1.2019 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698 15.1.2019 14.1.2019 Cyltezo Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/17/1240 16.1.2019 14.1.2019 Onivyde Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/16/1130 16.1.2019 15.1.2019 Anoro Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/898 17.1.2019 15.1.2019 Armisarte Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/15/1063 17.1.2019 15.1.2019 Caprelsa Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland EU/1/11/749 17.1.2019 15.1.2019 Hemangiol Pierre Fabre Dermatologie 45 place Abel Gance, 92100 Boulogne, France EU/1/14/919 17.1.2019 15.1.2019 Holoclar Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/987 17.1.2019 15.1.2019 Natpar Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, IRELAND EU/1/15/1078 17.1.2019 15.1.2019 Orkambi Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/15/1059 17.1.2019 15.1.2019 RoActemra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/08/492 17.1.2019 15.1.2019 Ulunar Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/917 17.1.2019 17.1.2019 CRYSVITA Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/17/1262 21.1.2019 18.1.2019 Adempas Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/907 22.1.2019 18.1.2019 Blincyto Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1047 22.1.2019 18.1.2019 Dexdor Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/11/718 22.1.2019 18.1.2019 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/02/205 22.1.2019 18.1.2019 Silapo STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland EU/1/07/432 22.1.2019 21.1.2019 Humalog Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/96/007 23.1.2019 21.1.2019 Lonquex Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/13/856 23.1.2019 23.1.2019 Axumin Blue Earth Diagnostics Ireland Ltd 6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland EU/1/17/1186 25.1.2019 23.1.2019 Biopoin Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/09/565 25.1.2019 23.1.2019 Bronchitol Pharmaxis Europe Limited 108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland EU/1/12/760 25.1.2019 23.1.2019 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/12/792 25.1.2019 23.1.2019 Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1148 6.2.2019 23.1.2019 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/00/152 25.1.2019 23.1.2019 Juluca ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/18/1282 25.1.2019 23.1.2019 Luxturna Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1331 25.1.2019 23.1.2019 OCALIVA Intercept Pharma International Ltd 10 Earlsfort Terrace, Dublin 2, Ireland EU/1/16/1139 28.1.2019 23.1.2019 Pregabalin Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1027 25.1.2019 23.1.2019 Rapiscan GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge EU/1/10/643 25.1.2019 23.1.2019 Revestive Shire Pharmaceuticals Ireland Limited Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland EU/1/12/787 25.1.2019 23.1.2019 Rubraca Clovis Oncology Ireland Limited Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland EU/1/17/1250 25.1.2019 23.1.2019 Topotecan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/552 25.1.2019 23.1.2019 Trimbow Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/17/1208 25.1.2019 23.1.2019 Zoely Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/11/690 25.1.2019 31.1.2019 Aripiprazole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1045 4.2.2019 31.1.2019 Clopidogrel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/540 4.2.2019 31.1.2019 Combivir ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/98/058 4.2.2019 31.1.2019 Elmiron bene-Arzneimittel GmbH Herterichstraße 1-3, 81479 München, Deutschland EU/1/17/1189 4.2.2019 31.1.2019 Feraccru Norgine B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland EU/1/15/1075 4.2.2019 31.1.2019 Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/13/876 4.2.2019 31.1.2019 Memantine Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/13/880 4.2.2019 31.1.2019 Nplate Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/08/497 4.2.2019 31.1.2019 Olanzapine Glenmark Glenmark Arzneimittel GmbH Industriestr. 31, D — 82194 Gröbenzell, Deutschland EU/1/09/587 4.2.2019 31.1.2019 Olanzapine Glenmark Europe Glenmark Arzneimittel GmbH Industriestr. 31, D — 82194 Gröbenzell, Deutschland EU/1/09/588 4.2.2019 31.1.2019 Onivyde Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/16/1130 4.2.2019 31.1.2019 Plenadren Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/715 4.2.2019 31.1.2019 Privigen CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/08/446 4.2.2019 31.1.2019 Resolor Shire Pharmaceuticals Ireland Limited Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland EU/1/09/581 4.2.2019 31.1.2019 Respreeza CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/15/1006 4.2.2019 31.1.2019 Revestive Shire Pharmaceuticals Ireland Limited Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland EU/1/12/787 4.2.2019 31.1.2019 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267 4.2.2019 31.1.2019 Stalevo Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/03/260 4.2.2019 31.1.2019 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron, 92165 Antony Cedex, France EU/1/95/002 4.2.2019 31.1.2019 Vizarsin Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/551 4.2.2019 31.1.2019 Xaluprine Nova Laboratories Ireland Limited 3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland EU/1/11/727 4.2.2019 31.1.2019 Zoely Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/11/690 4.2.2019

— 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 11.1.2019 Topotecan Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/09/536 15.1.2019 15.1.2019 Cyltezo Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/17/1240 17.1.2019

— 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 9.1.2019 Isemid Torasemide Ceva Santé Animale 10 avenue de la Ballastière, 33500 Libourne, France EU/2/18/232 Chewable tablet QC03CA04 11.1.2019 9.1.2019 Syvazul BTV Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3) LABORATORIOS SYVA, S.A.U. Av. Párroco Pablo Diez 49-57, 24010 León, España EU/2/18/231 Suspension for injection QI04AA02 11.1.2019

— 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 9.1.2019 Parvoduk Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/14/162 11.1.2019 11.1.2019 Meloxidyl Ceva Santé Animale 10 avenue de la Ballastière, 33500 Libourne, France EU/2/06/070 15.1.2019 23.1.2019 Loxicom Norbrook Laboratories Ltd Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090 25.1.2019 24.1.2019 Clomicalm Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/98/007 28.1.2019

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.