Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2022 to 31 August 2022

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))

(2022/C 376/01)

— 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 8.8.2022 Veklury remdesivir Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1459 Concentrate for solution for infusion Powder for concentrate for solution for infusion J05AB16 8.8.2022 10.8.2022 Vyvgart efgartigimod alfa argenx BV Industriepark-Zwijnaarde 7, 9052 Gent, België EU/1/22/1674 Concentrate for solution for infusion L04AA58 11.8.2022 17.8.2022 Pepaxti melphalan flufenamide Oncopeptides AB (publ) Västra Trädgårdsgatan 15, 111 53 Stockholm, Sverige EU/1/22/1669 Powder for concentrate for solution for infusion L01AA10 18.8.2022 17.8.2022 RAYVOW lasmiditan Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/21/1587 Film-coated tablet N02CC 19.8.2022 17.8.2022 Sunlenca lenacapavir Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/22/1671 Film-coated tablet Solution for injection J05AX31 19.8.2022 17.8.2022 VEGZELMA bevacizumab Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/22/1667 Concentrate for solution for infusion L01XC07 18.8.2022 23.8.2022 TECVAYLI teclistamab Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/22/1675 Solution for injection L01F 24.8.2022 24.8.2022 Roctavian valoctocogene roxaparvovec BioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland EU/1/22/1668 Solution for infusion Pending 25.8.2022 25.8.2022 Ranivisio ranibizumab Midas Pharma GmbH Rheinstraße 49, D-55218 Ingelheim, Deutschland EU/1/22/1673 Solution for injection S01LA04 26.8.2022 25.8.2022 Scemblix asciminib Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/22/1670 Film-coated tablet L01EA06 26.8.2022

— 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 2.8.2022 Alecensa Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/16/1169 4.8.2022 2.8.2022 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 3.8.2022 2.8.2022 Lynparza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/959 3.8.2022 2.8.2022 Neofordex Laboratoires CTRS 63 rue de l'Est, 92100 Boulogne-Billancourt, France EU/1/15/1053 24.8.2022 2.8.2022 Prialt Esteve Pharmaceuticals GmbH Hohenzollerndamm 150-151, 14199 Berlin, Deutschland EU/1/04/302 3.8.2022 2.8.2022 Vaxchora Emergent Netherlands B.V. Strawinskylaan 411, 1077 XX Amsterdam, Nederland EU/1/20/1423 8.8.2022 5.8.2022 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 5.8.2022 5.8.2022 Synagis AstraZeneca AB 151 85 Södertälje, Sverige EU/1/99/117 9.8.2022 5.8.2022 Tacforius Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/17/1244 9.8.2022 5.8.2022 Xermelo SERB SAS 40 Avenue George V, 75008 Paris, France EU/1/17/1224 11.8.2022 8.8.2022 Fasenra AstraZeneca AB 151 85 Södertälje, Sverige EU/1/17/1252 9.8.2022 8.8.2022 Vaxzevria AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1529 8.8.2022 12.8.2022 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118 19.8.2022 12.8.2022 Bortezomib SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/16/1102 22.8.2022 12.8.2022 Brintellix H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/13/891 29.8.2022 12.8.2022 Effentora Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/441 16.8.2022 12.8.2022 Genvoya Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/15/1061 16.8.2022 12.8.2022 Lenalidomide Krka d.d. Novo mesto KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/20/1520 6.9.2022 12.8.2022 NexoBrid MediWound Germany GmbH Hans-Sachs-Strasse 100, 65428 Rüsselsheim, Deutschland EU/1/12/803 16.8.2022 12.8.2022 Sustiva Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/99/110 16.8.2022 12.8.2022 Synflorix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/508 1.9.2022 16.8.2022 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España EU/1/20/1507 22.8.2022 17.8.2022 Blitzima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1205 18.8.2022 17.8.2022 Cuprior Orphalan 226 Boulevard Voltaire, 75011 Paris, France EU/1/17/1199 24.8.2022 17.8.2022 Fetcroja Shionogi B.V. Kingsfordweg 151, 1043 GR Amsterdam, Nederland EU/1/20/1434 24.8.2022 17.8.2022 Mabthera Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/98/067 18.8.2022 17.8.2022 Piqray Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1455 18.8.2022 17.8.2022 Procysbi Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/13/861 18.8.2022 17.8.2022 Rixathon Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1185 22.8.2022 17.8.2022 Riximyo Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1184 22.8.2022 17.8.2022 Vemlidy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1154 19.8.2022 22.8.2022 Granupas Eurocept International B.V. Trapgans 5, 1244 RL Ankeveen, Nederland EU/1/13/896 5.9.2022 22.8.2022 Imfinzi AstraZeneca AB 151 85 Södertälje, Sverige EU/1/18/1322 23.8.2022 22.8.2022 Onivyde pegylated liposomal Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/16/1130 23.8.2022 22.8.2022 Ritonavir Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/17/1242 23.8.2022 22.8.2022 Suliqua Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/16/1157 23.8.2022 24.8.2022 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 25.8.2022 24.8.2022 Lacosamide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/17/1230 25.8.2022 24.8.2022 PREVYMIS Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/17/1245 5.9.2022 24.8.2022 Ruxience Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/20/1431 25.8.2022 25.8.2022 Enhertu Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/20/1508 30.8.2022 25.8.2022 Exjade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/356 26.8.2022 25.8.2022 Myozyme Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/06/333 29.8.2022 25.8.2022 VITRAKVI Bayer AG D-51368 Leverkusen, Deutschland EU/1/19/1385 30.8.2022 25.8.2022 Zolgensma Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1443 26.8.2022

— 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 5.8.2022 Zalviso FGK Representative Service GmbH Heimeranstraße 35, 80339 München, Deutschland EU/1/15/1042 9.8.2022

— Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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 12.8.2022 Coxatab firocoxib CP-Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf, Deutschland EU/2/22/286 Chewable tablet QM01AH90 16.8.2022

— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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 2.8.2022 Bravecto Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/13/158 3.8.2022 5.8.2022 Credelio Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/17/206 8.8.2022 5.8.2022 Meloxidyl Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/06/070 8.8.2022 5.8.2022 Solensia Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/20/269 8.8.2022 12.8.2022 NexGard Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/13/159 16.8.2022 12.8.2022 Prevomax Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/17/211 17.8.2022 19.8.2022 LETIFEND LETI Pharma, S.L.U. C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760 Madrid, España EU/2/16/195 30.8.2022 25.8.2022 Porcilis PCV ID Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/15/187 1.9.2022 26.8.2022 GUMBOHATCH Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/19/245 29.8.2022

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.

(2) OJ L 4, 7.1.2019, p. 43.