Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2020 to 31 December 2020

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

(2021/C 33/01)

— 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 9.12.2020 Leqvio inclisiran Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1494 Solution for injection C10AX16 10.12.2020 9.12.2020 TRIXEO AEROSPHERE Formoterol / glycopyrronium bromide / budesonide AstraZeneca AB 151 85 Södertälje, Sverige EU/1/20/1498 Pressurised inhalation, suspension R03AL11 10.12.2020 14.12.2020 Tecartus autologous anti-CD19-transduced CD3+ cells Kite Pharma EU B.V. Tufsteen 1, 2132 NT Hoofddorp, Nederland EU/1/20/1492 Dispersion for infusion L01X 15.12.2020 17.12.2020 Libmeldy autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene Orchard Therapeutics (Netherlands) B.V. Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland EU/1/20/1493 Dispersion for infusion Pending 18.12.2020 17.12.2020 REKAMBYS rilpivirine Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1482 Prolonged release suspension for injection J05AG05 21.12.2020 17.12.2020 Vocabria cabotegravir ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/20/1481 Film-coated tablet Prolonged release suspension for injection J05AJ04 21.12.2020 18.12.2020 Fintepla fenfluramine Zogenix ROI Limited Trinity House, Charleston Road, Ranelagh, Dublin 6, D06 C8X4, Ireland EU/1/20/1491 Oral solution N03AX 21.12.2020 18.12.2020 Lenalidomide Mylan lenalidomide Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1490 Capsule, hard L04AX04 21.12.2020 21.12.2020 Phesgo pertuzumab / trastuzumab Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/20/1497 Solution for injection L01XY02 22.12.2020

— 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 1.12.2020 Vimpat UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/08/470 2.12.2020 1.12.2020 Zonisamide Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1093 4.12.2020 9.12.2020 Aldara Meda AB Pipers väg 2A, 170 73 Solna, Sverige EU/1/98/080 11.12.2020 9.12.2020 Caspofungin Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/15/1081 11.12.2020 9.12.2020 Epidyolex GW Pharma (International) B.V. Databankweg 26, 3821AL Amersfoort, Nederland EU/1/19/1389 11.12.2020 9.12.2020 Inlyta Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/12/777 11.12.2020 9.12.2020 Kadcyla Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/13/885 10.12.2020 9.12.2020 Lucentis Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/374 10.12.2020 9.12.2020 MAVENCLAD Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/17/1212 11.1.2021 9.12.2020 Miglustat Dipharma Dipharma B.V. Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland EU/1/18/1346 10.12.2020 9.12.2020 Neofordex Laboratoires CTRS 63 rue de l'Est, 92100 Boulogne-Billancourt, France EU/1/15/1053 11.12.2020 9.12.2020 Olazax Disperzi Glenmark Pharmaceuticals s.r.o. Hvězdova 1716/2b, 14078 Praha 4, Česká republika EU/1/09/592 11.12.2020 9.12.2020 Onbrez Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/593 10.12.2020 9.12.2020 Orbactiv Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Luxembourg EU/1/15/989 10.12.2020 9.12.2020 Orencia Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/07/389 10.12.2020 9.12.2020 Polivy Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/19/1388 10.12.2020 9.12.2020 SCENESSE Clinuvel Europe Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland EU/1/14/969 10.12.2020 9.12.2020 Seebri Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/788 10.12.2020 9.12.2020 Tovanor Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/790 6.1.2021 14.12.2020 ADCETRIS Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/12/794 15.12.2020 14.12.2020 Bosulif Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/13/818 15.12.2020 14.12.2020 Gilenya Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/11/677 15.12.2020 14.12.2020 Hirobriz Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/594 17.12.2020 14.12.2020 Jakavi Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/773 17.12.2020 14.12.2020 JEVTANA Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/11/676 17.12.2020 14.12.2020 Lonsurf Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes CEDEX, France EU/1/16/1096 15.12.2020 14.12.2020 Plegridy Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/14/934 15.12.2020 14.12.2020 Revatio Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/05/318 21.12.2020 14.12.2020 Uptravi Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/15/1083 16.12.2020 14.12.2020 Zyclara Meda AB Pipers väg 2A, 170 73 Solna, Sverige EU/1/12/783 17.12.2020 17.12.2020 Empliciti Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/16/1088 19.12.2020 17.12.2020 Halimatoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1288 7.1.2021 17.12.2020 Keppra UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/00/146 21.12.2020 17.12.2020 Kyprolis Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1060 18.12.2020 17.12.2020 Lorviqua Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/19/1355 18.12.2020 17.12.2020 Rubraca Clovis Oncology Ireland Limited Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland EU/1/17/1250 21.12.2020 17.12.2020 Taltz Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1085 22.12.2020 17.12.2020 Truberzi Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland EU/1/16/1126 30.12.2020 17.12.2020 Verzenios Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/18/1307 22.12.2020 17.12.2020 Votrient Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/10/628 20.12.2020 17.12.2020 Wakix Bioprojet Pharma 9 rue Rameau, 75002 Paris, France EU/1/15/1068 6.1.2021 17.12.2020 Xyrem UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/05/312 18.12.2020 17.12.2020 Ziextenzo Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1327 7.1.2021 18.12.2020 Cerezyme Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/97/053 21.12.2020 18.12.2020 Galvus Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/414 6.1.2021 18.12.2020 Jalra Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/485 6.1.2021 18.12.2020 Jivi Bayer AG D-51368 Leverkusen, Deutschland EU/1/18/1324 22.12.2020 18.12.2020 Pixuvri Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/12/764 22.12.2020 18.12.2020 Rixubis Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/14/970 22.12.2020 18.12.2020 Veklury Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1459 21.12.2020 18.12.2020 Xiliarx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/486 6.1.2021 21.12.2020 Veklury Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1459 22.12.2020 22.12.2020 BLINCYTO Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1047 25.12.2020 22.12.2020 Zirabev Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/18/1344 23.12.2020

— 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 17.12.2020 Prepandrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/08/453 4.1.2021 18.12.2020 Halimatoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1288 8.1.2021 18.12.2020 Truberzi Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland EU/1/16/1126 5.1.2021

— 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 3.12.2020 REXXOLIDE tulathromycin Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/20/263 Solution for injection QJ01FA94 9.12.2020 9.12.2020 CircoMax Myco Porcine circovirus vaccine (inactivated, recombinant) and Mycoplasma hyopneumoniae vaccine (inactivated) Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/20/264 Emulsion for injection QI09AL08 11.12.2020 9.12.2020 Enteroporc Coli AC Neonatal piglet colibacillosis (recombinant, inactivated) and Clostridium perfringens vaccine (inactivated) IDT Biologika GmbH Am Pharmapark, 06861 Dessau-Rosslau, Deutschland EU/2/20/262 Lyophilisate and suspension for suspension for injection Pending 10.12.2020 9.12.2020 Nobivac DP Plus Canine distemper vaccine (live) and canine parvovirus vaccine (live, recombinant) Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/20/265 Lyophilisate and solvent for suspension for injection QI07AD03 10.12.2020 9.12.2020 Vectormune FP ILT Fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant) Ceva-Phylaxia Co. Ltd. Szállás u. 5, 1107 Budapest, Magyarország EU/2/20/266 Lyophilisate and solvent for suspension for injection Pending 10.12.2020

— 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 3.12.2020 Bravecto Plus Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/18/224 4.12.2020 3.12.2020 Exzolt Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/17/212 4.12.2020 9.12.2020 Bravecto Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/13/158 10.12.2020 9.12.2020 Circovac Ceva-Phylaxia Zrt. Szállás u. 5, 1107 Budapest, Magyarország EU/2/07/075 11.12.2020 9.12.2020 Zulvac SBV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/178 11.12.2020 11.12.2020 Onsior Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/08/089 14.12.2020 17.12.2020 Nobilis IB 4-91 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/98/006 21.12.2020

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.