Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2019 to 30 June 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 252/01)

— 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 6.6.2019 Pixuvri pixantrone CTI Life Sciences Deutschland GmbH Universitätsstraβe 71, 50931 Köln, Deutschland EU/1/12/764 Powder for concentrate for solution for infusion L01DB11 11.6.2019 12.6.2019 Temybric Ellipta fluticasone furoate / umeclidinium / vilanterol GlaxoSmithKline Trading Services Limited Currabinny, Co. Cork, Ireland EU/1/19/1378 Inhalation powder, pre-dispensed R03AL08 14.6.2019 20.6.2019 Ambrisentan Mylan ambrisentan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/19/1368 Film-coated tablet C02KX02 24.6.2019 20.6.2019 Doptelet avatrombopag Dova Pharmaceuticals Ireland Limited 6th Floor, 2 Grand Canal Square, Dublin 2, D02 A342, Ireland EU/1/19/1373 Film-coated tablet B02BX08 24.6.2019 20.6.2019 Esperoct turoctocog alfa pegol Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/19/1374 Powder and solvent for solution for injection B02BD02 24.6.2019 20.6.2019 Grasustek pegfilgrastim Juta Pharma GmbH Gutenbergstr. 13, 24941, Flensburg, Deutschland EU/1/19/1375 Solution for injection L03AA13 24.6.2019 20.6.2019 Sixmo buprenorphine L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A Strada Statale 67, 50018 Scandicci (Firenze), Italia EU/1/19/1369 Implant N07BC01 25.6.2019 20.6.2019 Talzenna talazoparib Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/19/1377 Capsule, hard L01XX60 24.6.2019 20.6.2019 Trecondi treosulfan medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/18/1351 Powder for solution for infusion L01AB02 24.6.2019 25.6.2019 Striascan ioflupane (123I) CIS bio international Boite Postale 32, 91192 Gif-sur-Yvette, France EU/1/19/1372 Solution for injection V09AB03 27.6.2019 28.6.2019 LIBTAYO cemiplimab Regeneron Ireland U.C. Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland EU/1/19/1376 Concentrate for solution for infusion Pending 2.7.2019

— 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 6.6.2019 Actos Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/00/150 11.6.2019 6.6.2019 Advate Baxter AG Industriestraße 67, 1221 Wien, Österreich EU/1/03/271 11.6.2019 6.6.2019 Alpivab BioCryst UK Ltd c/o Morgan Lewis & Bockius, Condor House, 5 -10 St. Paul's Churchyard, London EC4M 8AL, United Kingdom EU/1/18/1269 10.6.2019 6.6.2019 Ammonaps Immedica Pharma AB Norrtullsgatan 15, SE-113 29, Stockholm, Sverige EU/1/99/120 10.6.2019 6.6.2019 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland EU/1/02/218 11.6.2019 6.6.2019 Azilect Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/04/304 11.6.2019 6.6.2019 Azopt Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/00/129 10.6.2019 6.6.2019 Betaferon Bayer AG D-51368 Leverkusen, Deutschland EU/1/95/003 11.6.2019 6.6.2019 Byetta AstraZeneca AB 151 85 Södertälje, Sverige EU/1/06/362 10.6.2019 6.6.2019 Clopidogrel TAD TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland EU/1/09/555 11.6.2019 6.6.2019 Descovy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1099 10.6.2019 6.6.2019 Effentora Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/441 11.6.2019 6.6.2019 Envarsus Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/935 10.6.2019 6.6.2019 Extavia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/454 10.6.2019 6.6.2019 Farydak Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/1023 10.6.2019 6.6.2019 Febuxostat Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1194 11.6.2019 6.6.2019 Genvoya Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/15/1061 10.6.2019 6.6.2019 Giotrif Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/13/879 11.6.2019 6.6.2019 Glubrava Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/07/421 11.6.2019 6.6.2019 Glyxambi Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/16/1146 11.6.2019 6.6.2019 Grepid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/09/535 10.6.2019 6.6.2019 Harvoni Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/14/958 10.6.2019 6.6.2019 Ilaris Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/564 10.6.2019 6.6.2019 Imlygic Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1064 11.6.2019 6.6.2019 Invega Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/07/395 11.6.2019 6.6.2019 Nexavar Bayer AG D-51368 Leverkusen, Deutschland EU/1/06/342 11.6.2019 6.6.2019 Odefsey Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1112 10.6.2019 6.6.2019 Protaphane Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/234 11.6.2019 6.6.2019 Ravicti Immedica Pharma AB SE-113 29 Stockholm, Sverige EU/1/15/1062 10.6.2019 6.6.2019 Rilutek Sanofi Mature IP 54 Rue de la Boetie, 75008, Paris, FRANCE EU/1/96/010 11.6.2019 6.6.2019 Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 11.6.2019 6.6.2019 Temozolomide HEXAL Hexal AG Industriestraße 25, 83607 Holzkirchen, Deutschland EU/1/10/616 11.6.2019 6.6.2019 Temozolomide Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/10/617 11.6.2019 6.6.2019 Translarna PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland EU/1/13/902 10.6.2019 6.6.2019 Veltassa Vifor Fresenius Medical Care Renal Pharma France 100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France EU/1/17/1179 11.6.2019 6.6.2019 Vosevi Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/17/1223 10.6.2019 6.6.2019 Zebinix Bial - Portela & Ca, SA À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal EU/1/09/514 11.6.2019 12.6.2019 Accofil Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/14/946 14.6.2019 12.6.2019 Aldara Meda AB Pipers väg 2A, 170 73 Solna, Sverige EU/1/98/080 14.6.2019 12.6.2019 Gardasil MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/357 14.6.2019 12.6.2019 Lucentis Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/374 14.6.2019 12.6.2019 Lynparza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/959 14.6.2019 12.6.2019 Olanzapine Apotex Apotex Europe B.V. Archimedesweg 2, 2333 CN, Leiden, Nederland EU/1/10/635 14.6.2019 12.6.2019 Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/09/605 14.6.2019 12.6.2019 Votubia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/11/710 14.6.2019 18.6.2019 Sialanar Proveca Pharma Limited Marine House, Clanwilliam Place, Dublin 2, Ireland EU/1/16/1135 20.6.2019 18.6.2019 Telzir ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/04/282 1.7.2019 20.6.2019 Azarga Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/482 25.6.2019 20.6.2019 Bavencio Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/17/1214 25.6.2019 20.6.2019 Busulfan Fresenius Kabi Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/14/951 25.6.2019 20.6.2019 Eurartesim Alfasigma S.p.A. Via Ragazzi del '99, n.5, 40133 Bologna, Italia EU/1/11/716 25.6.2019 20.6.2019 Moventig Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/14/962 25.6.2019 20.6.2019 Ocrevus Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1231 25.6.2019 20.6.2019 Palonosetron Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/16/1100 24.6.2019 20.6.2019 Potactasol Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/10/660 24.6.2019 20.6.2019 Saxenda Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/15/992 25.6.2019 20.6.2019 Skilarence Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/17/1201 25.6.2019 20.6.2019 Triumeq ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/14/940 25.6.2019 20.6.2019 Zejula TESARO Bio Netherlands B.V. Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht,Nederland EU/1/17/1235 24.6.2019 25.6.2019 Cuprior gmp-orphan SA Pépinière Paris Santé Cochin, 27-29 rue Faubourg Saint-Jacques, 75014 Paris, France EU/1/17/1199 27.6.2019 25.6.2019 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 27.6.2019 25.6.2019 Neofordex Laboratoires CTRS 63 rue de l'Est, 92100 Boulogne-Billancourt,France EU/1/15/1053 27.6.2019 28.6.2019 Brintellix H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/13/891 2.7.2019 28.6.2019 Darzalex Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/16/1101 2.7.2019 28.6.2019 Docetaxel Kabi Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/12/770 2.7.2019 28.6.2019 Mysimba Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/14/988 2.7.2019 28.6.2019 TOBI Podhaler Mylan IRE Healthcare Ltd Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/10/652 2.7.2019 28.6.2019 Venclyxto AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/16/1138 2.7.2019 28.6.2019 Xgeva Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/11/703 2.7.2019

— 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 6.6.2019 Clopidogrel HCS HCS bvba H. Kennisstraat 53, 2650 Edegem, België EU/1/10/651 11.6.2019 6.6.2019 Ketek Aventis Pharma S.A. 20 avenue Raymond Aron, 92165 Antony CEDEX, France EU/1/01/191 11.6.2019 25.6.2019 Palonosetron Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/16/1100 27.6.2019

— 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 19.6.2019 HorStem equine umbilical cord mesenchymal stem cells EquiCord-YMAS S.L. 103-D Loeches, Polígono. Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España EU/2/18/226 Suspension for injection Pending 21.6.2019

— 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 13.6.2019 Nobilis IB Primo QX Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/14/174 17.6.2019 18.6.2019 Suvaxyn PRRS MLV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/215 20.6.2019

— Withdrawal of a marketing authorisation (Article 38 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 18.6.2019 Bovalto Ibraxion Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/99/017 20.6.2019 18.6.2019 Ingelvac PCV FLEX Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/17/208 21.6.2019

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 Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands

(1) OJ L 136, 30.4.2004, p. 1.