Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2020 to 30 June 2020

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

(2020/C 253/01)

— 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 18.6.2020 Paliperidone Janssen-Cilag International paliperidone Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1453 Prolonged release suspension for injection N05AX13 19.6.2020 25.6.2020 Fingolimod Accord fingolimod Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/20/1450 Capsule, hard L04AA27 6.7.2020 25.6.2020 Insulin aspart Sanofi insulin aspart Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/20/1447 Solution for injection A10AB05 26.6.2020 25.6.2020 Reblozyl luspatercept Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/20/1452 Powder for solution for injection B03XA06 26.6.2020 26.6.2020 Daurismo glasdegib Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/20/1451 Film-coated tablet L01XX63 29.6.2020

— 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 2.6.2020 AMGEVITA Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1164 3.6.2020 2.6.2020 Aripiprazole Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1009 14.6.2020 2.6.2020 Braftovi Pierre Fabre Médicament 45, place Abel Gance, 92100 Boulogne-Billancourt, France EU/1/18/1314 3.6.2020 2.6.2020 Brinavess Correvio 15 rue du Bicentenaire, 92800 Puteaux, France EU/1/10/645 3.6.2020 2.6.2020 Cinacalcet Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1054 8.6.2020 2.6.2020 Clopidogrel TAD TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland EU/1/09/555 4.6.2020 2.6.2020 Constella Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland EU/1/12/801 3.6.2020 2.6.2020 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1263 4.6.2020 2.6.2020 Farydak Secura Bio Limited 32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland EU/1/15/1023 8.6.2020 2.6.2020 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 11.6.2020 2.6.2020 Lyrica Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/04/279 3.6.2020 2.6.2020 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 3.6.2020 2.6.2020 Multaq Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/09/591 3.6.2020 2.6.2020 Nustendi Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/20/1424 3.6.2020 2.6.2020 Pemetrexed Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1034 3.6.2020 2.6.2020 Praluent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/15/1031 4.6.2020 2.6.2020 Pregabalin Pfizer Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/14/916 3.6.2020 2.6.2020 Revatio Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/05/318 3.6.2020 2.6.2020 Revlimid Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/07/391 3.6.2020 2.6.2020 Taltz Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1085 11.6.2020 2.6.2020 Thalidomide Celgene Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/08/443 3.6.2020 2.6.2020 Viagra Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/98/077 3.6.2020 3.6.2020 Carmustine Obvius Obvius Investment B.V. De Cuserstraat 93, 1081 CN Amsterdam, Nederland EU/1/18/1278 4.6.2020 3.6.2020 Darzalex Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/16/1101 4.6.2020 3.6.2020 Ecalta Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/07/416 4.6.2020 3.6.2020 Imnovid Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/13/850 4.6.2020 3.6.2020 Zyllt KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/553 8.6.2020 9.6.2020 Cablivi Ablynx N.V. Technologiepark 21, 9052 Zwijnaarde, België EU/1/18/1305 11.6.2020 9.6.2020 Granupas Eurocept International B.V. Trapgans 5, 1244 RL Ankeveen, Nederland EU/1/13/896 10.6.2020 9.6.2020 Jakavi Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/773 10.6.2020 9.6.2020 Kalydeco Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/12/782 10.6.2020 9.6.2020 Kiovig Takeda Manufacturing Austria AG Industriestraße 67, 1221 Wien, Österreich EU/1/05/329 6.7.2020 9.6.2020 Qarziba EUSA Pharma (Netherlands) B.V. Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland EU/1/17/1191 6.7.2020 9.6.2020 Zoely Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/11/690 10.6.2020 12.6.2020 Buvidal Camurus AB Ideon Science Park, 223 70 Lund, Sverige EU/1/18/1336 15.6.2020 12.6.2020 Deferiprone Lipomed Lipomed GmbH Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland EU/1/18/1310 15.6.2020 12.6.2020 Duloxetine Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/972 15.6.2020 12.6.2020 Eviplera Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/11/737 15.6.2020 12.6.2020 Holoclar Holostem Terapie Avanzate S.r.l. Via Glauco Gottardi 100, Modena, MO 41125, Italia EU/1/14/987 15.6.2020 12.6.2020 Memantine Merz Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland EU/1/12/799 15.6.2020 12.6.2020 Nilemdo Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/20/1425 17.6.2020 12.6.2020 PHEBURANE Eurocept International BV Trapgans 5, 1244 RL Ankeveen, Nederland EU/1/13/822 29.6.2020 17.6.2020 Exforge HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/569 18.6.2020 17.6.2020 Ogivri Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1341 18.6.2020 17.6.2020 Ratiograstim ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/08/444 18.6.2020 18.6.2020 Copalia HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/575 19.6.2020 18.6.2020 Dafiro HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/574 22.6.2020 18.6.2020 Hexacima Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/13/828 19.6.2020 18.6.2020 Hexyon Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/13/829 19.6.2020 18.6.2020 Idacio Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/19/1356 19.6.2020 18.6.2020 IDELVION CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/16/1095 25.6.2020 18.6.2020 Ovaleap Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/13/871 19.6.2020 18.6.2020 PecFent Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/10/644 19.6.2020 18.6.2020 Tevagrastim Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/08/445 19.6.2020 18.6.2020 Trumenba Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/17/1187 19.6.2020 18.6.2020 VPRIV Shire Pharmaceuticals Ireland Limited Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/10/646 19.6.2020 18.6.2020 Xagrid Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland EU/1/04/295 19.6.2020 19.6.2020 Pregabalin Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1011 6.7.2020 19.6.2020 Pregabalin Sandoz GmbH Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1012 3.7.2020 25.6.2020 Aflunov Seqirus S.r.l. Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italy EU/1/10/658 29.6.2020 25.6.2020 Cotellic Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/15/1048 26.6.2020 25.6.2020 Dupixent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1229 26.6.2020 25.6.2020 Entresto Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/1058 29.6.2020 25.6.2020 Erbitux Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/04/281 29.6.2020 25.6.2020 Intuniv Shire Pharmaceuticals Ireland Limited Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/15/1040 26.6.2020 25.6.2020 Kisplyx Eisai GmbH Lyoner Strasse 36, 60528 Frankfurt am Main, Deutschland EU/1/16/1128 4.7.2020 25.6.2020 Kyprolis Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1060 29.6.2020 25.6.2020 Mysildecard Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1134 6.7.2020 25.6.2020 Neofordex Laboratoires CTRS 63 rue de l’Est, 92100 Boulogne-Billancourt, France EU/1/15/1053 29.6.2020 25.6.2020 Olanzapine Apotex Apotex Europe B.V. Archimedesweg 2, 2333 CN, Leiden, Nederland EU/1/10/635 1.7.2020 25.6.2020 Sovaldi Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/894 26.6.2020 25.6.2020 Ultomiris Alexion Europe SAS 103-105 Rue Anatole France, 92300 Levallois-Perret, France EU/1/19/1371 26.6.2020 25.6.2020 Wakix Bioprojet Pharma 9 rue Rameau, 75002 Paris, France EU/1/15/1068 26.6.2020 25.6.2020 Zejula GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1235 26.6.2020 26.6.2020 AJOVY Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/19/1358 30.6.2020 26.6.2020 Aripiprazole Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1029 30.6.2020 26.6.2020 Benlysta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/11/700 6.7.2020 26.6.2020 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 30.6.2020 26.6.2020 Copalia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/372 29.6.2020 26.6.2020 Dafiro Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/371 29.6.2020 26.6.2020 Invokana Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/884 29.6.2020 26.6.2020 LIBTAYO Regeneron Ireland Designated Activity Company (DAC) Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland EU/1/19/1376 29.6.2020 26.6.2020 Pramipexole Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/490 30.6.2020 26.6.2020 Sivextro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/991 7.7.2020 26.6.2020 Taltz Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1085 30.6.2020 26.6.2020 Talzenna Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/19/1377 29.6.2020

— 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 22.6.2020 Zerit Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/96/009 25.6.2020

— 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 5.6.2020 Recocam Bimeda Animal Health Limited 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland EU/2/11/133 9.6.2020 17.6.2020 Profender Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/05/054 18.6.2020 17.6.2020 Zulvac 1 + 8 Ovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/120 19.6.2020 24.6.2020 Aivlosin ECO Animal Health Europe Limited 6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland EU/2/04/044 25.6.2020 24.6.2020 Mirataz Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/19/247 25.6.2020 24.6.2020 UpCard Vétoquinol SA Magny-Vernois, 70200 Lure, France EU/2/15/184 1.7.2020 24.6.2020 Zulvac BTV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/207 29.6.2020

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 NETHERLANDS

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