Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2019 to 30 September 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 369/01)

— Issuing of a marketing authorization (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 authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 19.9.2019 Epidyolex cannabidiol GW Pharma (International) B.V. Amersfoort A1, Databankweg 26, 3821AL Amersfoort, Nederland EU/1/19/1389 Oral solution N03AX24 23.9.2019 19.9.2019 Inbrija levodopa Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland EU/1/19/1390 Inhalation powder, hard capsule N04BA01 23.9.2019 19.9.2019 VITRAKVI larotrectinib Bayer AG D-51368 Leverkusen, Deutschland EU/1/19/1385 Capsule, hard Oral solution L01XE53 23.9.2019 26.9.2019 Deferasirox Mylan deferasirox Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/19/1386 Film-coated tablet V03AC03 30.9.2019 26.9.2019 Trogarzo ibalizumab Theratechnologies International Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland EU/1/19/1359 Concentrate for solution for infusion J05AX23 30.9.2019 27.9.2019 NUCEIVA botulinum toxin type A Evolus Pharma Limited 70 Sir John Rogerson's Quay, Dublin 2, Ireland EU/1/19/1364 Powder for solution for injection M03AX01 1.10.2019

— Modification of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 3.9.2019 AMGLIDIA AMMTeK 55 rue de Turbigo, 75003 Paris, France EU/1/18/1279 5.9.2019 3.9.2019 Clopidogrel Zentiva Zentiva, k.s. U Kabelovny 130, 10 237 Praha 10, Česká republika EU/1/08/465 5.9.2019 3.9.2019 Cosentyx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/980 5.9.2019 3.9.2019 DuoPlavin Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France EU/1/10/619 5.9.2019 3.9.2019 Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 10 237 Praha 10, Česká republika EU/1/16/1148 5.9.2019 3.9.2019 GILENYA Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/11/677 5.9.2019 3.9.2019 Lonsurf Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes CEDEX, France EU/1/16/1096 5.9.2019 3.9.2019 Lucentis Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/374 5.9.2019 3.9.2019 Pramipexole Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/490 5.9.2019 3.9.2019 Stelara Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/08/494 5.9.2019 3.9.2019 Suliqua Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/16/1157 5.9.2019 3.9.2019 Sylvant EUSA Pharma (Netherlands) B.V. Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland EU/1/14/928 5.9.2019 3.9.2019 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 5.9.2019 6.9.2019 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 10.9.2019 6.9.2019 Pylobactell Torbet Laboratories Ireland Limited 20 Holles Street, Dublin 2, Ireland EU/1/98/064 10.9.2019 6.9.2019 Rasagiline ratiopharm Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/977 10.9.2019 9.9.2019 Fexeric Akebia Europe Limited c/o Matheson, 70 Sir John Rogerson’s Quay, Dublin 2, Ireland EU/1/15/1039 11.9.2019 9.9.2019 Kovaltry Bayer AG D-51368 Leverkusen, Deutschland EU/1/15/1076 11.9.2019 13.9.2019 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430 17.9.2019 13.9.2019 Kyntheum Leo Pharma A/S Industriparken 55, 2750 Ballerup, Danmark EU/1/16/1155 17.9.2019 13.9.2019 Levetiracetam Actavis Group Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland EU/1/11/738 17.9.2019 13.9.2019 Opatanol Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/02/217 17.9.2019 13.9.2019 Prepandrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/08/453 17.9.2019 13.9.2019 Rapamune Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/01/171 17.9.2019 13.9.2019 Sivextro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/991 17.9.2019 13.9.2019 Twinrix Adult GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/96/020 17.9.2019 13.9.2019 Twinrix Paediatric GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/97/029 17.9.2019 16.9.2019 Champix Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/06/360 18.9.2019 16.9.2019 Cosentyx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/980 18.9.2019 16.9.2019 Elonva Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/09/609 18.9.2019 16.9.2019 Fertavid Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/09/510 18.9.2019 16.9.2019 Inflectra Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/13/854 18.9.2019 16.9.2019 Laventair Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/899 18.9.2019 16.9.2019 Lymphoseek Norgine B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland EU/1/14/955 18.9.2019 16.9.2019 Mepsevii Ultragenyx Germany GmbH Friedrichstraße 191, 10117 Berlin, Deutschland EU/1/18/1301 18.9.2019 16.9.2019 Ninlaro Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/16/1094 18.9.2019 16.9.2019 Nivestim Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/10/631 18.9.2019 16.9.2019 Olumiant Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/1170 18.9.2019 16.9.2019 Pregabalin Zentiva Zentiva, k.s. U Kabelovny 130, 10 237 Praha 10, Česká republika EU/1/15/1021 18.9.2019 16.9.2019 Remsima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/13/853 18.9.2019 16.9.2019 Riximyo Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1184 18.9.2019 16.9.2019 Somavert Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/02/240 18.9.2019 16.9.2019 Stelara Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/08/494 18.9.2019 16.9.2019 Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 10 237 Praha 10, Česká republika EU/1/16/1127 18.9.2019 19.9.2019 ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/794 23.9.2019 19.9.2019 Anoro Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/898 23.9.2019 19.9.2019 Ganfort Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/06/340 23.9.2019 19.9.2019 Lumark IDB Holland B.V. Weverstraat 17, 5111 PV Baarle-Nassau, Nederland EU/1/15/1013 23.9.2019 19.9.2019 Lysodren HRA Pharma Rare Diseases 200 avenue de Paris, 92 320 Chatillon, France EU/1/04/273 23.9.2019 19.9.2019 Multaq Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/09/591 23.9.2019 19.9.2019 Tegsedi Akcea Therapeutics Ireland Ltd Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland EU/1/18/1296 23.9.2019 19.9.2019 Tyverb Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/440 23.9.2019 19.9.2019 Viekirax AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/982 23.9.2019 19.9.2019 Xadago Zambon S.p.A. Via Lillo del Duca 10, 20 091 Bresso (MI), Italia EU/1/14/984 23.9.2019 23.9.2019 APTIVUS Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/05/315 25.9.2019 23.9.2019 BYDUREON AstraZeneca AB 15 185 Södertälje, Sverige EU/1/11/696 25.9.2019 23.9.2019 Caelyx Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/96/011 25.10.2019 23.9.2019 Ciambra Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg EU/1/15/1055 25.9.2019 23.9.2019 EndolucinBeta ITG Isotope Technologies Garching GmbH Lichtenbergstraße 1, 85748 Garching, Deutschland EU/1/16/1105 25.9.2019 23.9.2019 Epclusa Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1116 25.9.2019 23.9.2019 Hyrimoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1286 25.9.2019 23.9.2019 Incruse Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/922 25.9.2019 23.9.2019 Moventig Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/14/962 25.9.2019 23.9.2019 Myalepta Aegerion Pharmaceuticals B.V. Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland EU/1/18/1276 25.9.2019 23.9.2019 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/979 25.9.2019 23.9.2019 Parsabiv Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1142 25.9.2019 23.9.2019 Rixathon Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1185 25.9.2019 23.9.2019 Saxenda Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/15/992 25.9.2019 23.9.2019 Thyrogen Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/99/122 25.9.2019 23.9.2019 Tolura Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/10/632 25.9.2019 23.9.2019 Vectibix Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/07/423 25.9.2019 26.9.2019 Cyramza Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/957 30.9.2019 26.9.2019 Exviera AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/983 30.9.2019 26.9.2019 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 30.9.2019 26.9.2019 Rolufta Ellipta GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/17/1174 30.9.2019 26.9.2019 Vosevi Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/17/1223 30.9.2019

— Withdrawal of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 3.9.2019 Iblias Bayer AG D-51368 Leverkusen, Deutschland EU/1/15/1077 5.9.2019

— Issuing of a marketing authorization (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 authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 17.9.2019 Simparica Trio sarolaner / moxidectin / pyrantel embonate Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/19/243 Chewable tablet QP54AB52 19.9.2019

— Modification of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 6.9.2019 RESPIPORC FLUpan H1N1 IDT Biologika GmbH Am Pharmapark, 06861 Dessau-Rosslau, Deutschland EU/2/17/209 10.9.2019 13.9.2019 Porcilis PCV M Hyo Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/14/175 17.9.2019 20.9.2019 Cepedex CP-Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf, Deutschland EU/2/16/200 24.9.2019

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.