Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2022 to 30 April 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 215/01)

— 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 1.4.2022 KIMMTRAK tebentafusp Immunocore Ireland Limited Unit 1 Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, Dublin, D17 FY82, Ireland EU/1/22/1630 Concentrate for solution for infusion Pending 6.4.2022 4.4.2022 Breyanzi lisocabtagene maraleucel Bristol Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/22/1631 Dispersion for infusion Pending 5.4.2022 7.4.2022 Bosulif Bosutinib Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/13/818 Film-coated tablet L01XE14 8.4.2022 13.4.2022 Padcev enfortumab vedotin Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/21/1615 Powder for concentrate for solution for infusion L01FX13 19.4.2022 25.4.2022 Inpremzia insulin human (rDNA) Baxter Holding B.V. Kobaltweg 49, 3542 CE Utrecht, Nederland EU/1/22/1644 Solution for infusion A10AB01 27.4.2022 25.4.2022 Kapruvia difelikefalin Vifor Fresenius Medical Care Renal Pharma France 100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France EU/1/22/1643 Solution for injection V03AX04 27.4.2022 25.4.2022 PreHevbri Hepatitis B vaccine (recombinant, adsorbed) VBI Vaccines B.V. Delflandlaan 1, Queen’s Tower Office Number 714, 1062 EA Amsterdam, Nederland EU/1/22/1641 Suspension for injection J07BC01 27.4.2022 25.4.2022 Sitagliptin Accord Sitagliptin Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/22/1633 Film-coated tablet A10BH01 26.4.2022 25.4.2022 Truvelog Mix 30 insulin aspart Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/22/1639 Suspension for injection A10AD05 26.4.2022 25.4.2022 Uplizna inebilizumab Viela Bio B.V. Schiphol Boulevard 359, 1118 BJ Schiphol, Nederland EU/1/21/1602 Concentrate for solution for infusion L04AA 29.4.2022 25.4.2022 Vydura rimegepant Biohaven Pharmaceutical Ireland DAC 6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland EU/1/22/1645 Oral lyophilisate N02CD 26.4.2022 29.4.2022 Orgovyx relugolix Myovant Sciences Ireland Limited Rocktwist House, Block 1 Western Business Park Shannon, Co. Clare V14 FW97, Ireland EU/1/22/1642 Film-coated tablet L02BX04 4.5.2022 29.4.2022 QUVIVIQ daridorexant Idorsia Pharmaceuticals Deutschland GmbH Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland EU/1/22/1638 Film-coated tablet Pending 2.5.2022

— 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 1.4.2022 Aclasta Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/05/308 5.4.2022 1.4.2022 Evista SUBSTIPHARM 24 rue Erlanger, 75016 Paris, France EU/1/98/073 20.4.2022 1.4.2022 Kyprolis Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1060 5.4.2022 1.4.2022 Naglazyme BioMarin International Limited Shanbally, Ringaskiddy, County Cork P43 R298, Ireland EU/1/05/324 6.4.2022 1.4.2022 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 4.4.2022 1.4.2022 Replagal Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/01/189 5.4.2022 1.4.2022 Revatio Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/05/318 12.4.2022 1.4.2022 RotaTeq Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/06/348 4.4.2022 1.4.2022 Ultomiris Alexion Europe SAS 103-105 Rue Anatole France, 92300 Levallois-Perret, France EU/1/19/1371 5.4.2022 1.4.2022 Verzenios Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/18/1307 4.4.2022 1.4.2022 YERVOY Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/11/698 4.4.2022 1.4.2022 Zostavax Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/06/341 4.4.2022 4.4.2022 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland EU/1/02/218 6.4.2022 4.4.2022 Bemrist Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1441 5.4.2022 4.4.2022 Capecitabine Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/12/762 5.4.2022 4.4.2022 Dupixent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1229 6.4.2022 4.4.2022 Elaprase Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/06/365 19.4.2022 4.4.2022 Erelzi Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1195 5.4.2022 4.4.2022 HBVAXPRO Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/01/183 6.4.2022 4.4.2022 Incresync Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/13/842 6.4.2022 4.4.2022 Kisqali Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/17/1221 5.4.2022 4.4.2022 Lorviqua Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/19/1355 6.4.2022 4.4.2022 Memantine Merz Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland EU/1/12/799 11.4.2022 4.4.2022 MenQuadfi Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/20/1483 5.4.2022 4.4.2022 Ratiograstim ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/08/444 5.4.2022 4.4.2022 Reagila Gedeon Richter Plc. Gyömrői út 19-21, 1103 Budapest, Magyarország EU/1/17/1209 7.4.2022 4.4.2022 Shingrix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/18/1272 5.4.2022 4.4.2022 Tevagrastim Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/08/445 6.4.2022 4.4.2022 Vipdomet Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/13/843 6.4.2022 4.4.2022 Vipidia Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/13/844 6.4.2022 7.4.2022 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 7.4.2022 7.4.2022 Pifeltro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1332 8.4.2022 12.4.2022 Veklury Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1459 22.4.2022 13.4.2022 ADCETRIS Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/12/794 21.4.2022 13.4.2022 Aldara Meda AB Pipers väg 2A, 170 73 Solna, Sverige EU/1/98/080 21.4.2022 13.4.2022 Evkeeza Ultragenyx Germany GmbH Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland EU/1/21/1551 20.4.2022 13.4.2022 Komboglyze AstraZeneca AB 151 85 Södertälje, Sverige EU/1/11/731 19.4.2022 13.4.2022 M-M-RVAXPRO Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/06/337 19.4.2022 13.4.2022 NeuroBloc Sloan Pharma S.a.r.l. 33 Rue de Puits Romain, 8070 Bertrange, Luxembourg EU/1/00/166 21.4.2022 13.4.2022 Onglyza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/09/545 19.4.2022 13.4.2022 ProQuad Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/05/323 19.4.2022 13.4.2022 Tremfya Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/17/1234 19.4.2022 20.4.2022 Zolgensma Novartis Gene Therapies EU Limited Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland EU/1/20/1443 21.4.2022 25.4.2022 Blitzima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1205 26.4.2022 25.4.2022 Byfavo PAION Netherlands B.V. Vogt 21, 6422 RK Heerlen, Nederland EU/1/20/1505 27.4.2022 25.4.2022 Fampyra Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/11/699 28.4.2022 25.4.2022 Fycompa Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/12/776 26.4.2022 25.4.2022 Ilumetri Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/18/1323 2.5.2022 25.4.2022 Kevzara Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1196 26.4.2022 25.4.2022 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 28.4.2022 25.4.2022 Koselugo AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1552 26.4.2022 25.4.2022 Kyntheum Leo Pharma A/S Industriparken 55, 2750 Ballerup, Danmark EU/1/16/1155 27.4.2022 25.4.2022 Lyumjev Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/20/1422 28.4.2022 25.4.2022 MAVENCLAD Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/17/1212 26.4.2022 25.4.2022 Nerlynx Pierre Fabre Médicament Les Cauquillous, 81500 Lavaur, France EU/1/18/1311 26.4.2022 25.4.2022 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 28.4.2022 25.4.2022 Sogroya Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/20/1501 27.4.2022 25.4.2022 Starlix Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/174 29.4.2022 25.4.2022 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 26.4.2022 25.4.2022 Trumenba Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/17/1187 26.4.2022 25.4.2022 Vazkepa Amarin Pharmaceuticals Ireland Limited 88 Harcourt Street, Dublin 2, D02DK18, Ireland EU/1/20/1524 26.4.2022 25.4.2022 Xofluza Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/20/1500 26.4.2022 28.4.2022 Gardasil 9 Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1007 29.4.2022 29.4.2022 Azacitidine Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/19/1413 2.5.2022 29.4.2022 CABOMETYX Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/16/1136 2.5.2022 29.4.2022 Ecansya KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/12/763 9.5.2022 29.4.2022 Gardasil Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/06/357 3.5.2022 29.4.2022 Gardasil 9 Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1007 2.5.2022 29.4.2022 HyQvia Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/13/840 2.5.2022 29.4.2022 Imraldi Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/17/1216 4.5.2022 29.4.2022 Ixiaro Valneva Austria GmbH Campus Vienna Biocenter 3, 1030 Wien, Österreich EU/1/08/501 2.5.2022 29.4.2022 Jakavi Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/773 3.5.2022 29.4.2022 Kalydeco Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland EU/1/12/782 5.5.2022 29.4.2022 Mekinist Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/931 3.5.2022 29.4.2022 Nucala GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/15/1043 2.5.2022 29.4.2022 Ondexxya Alexion Europe S.A.S. 103 Rue Anatole France, 92300 Levallois Perret, France EU/1/18/1345 4.5.2022 29.4.2022 Poteligeo Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/18/1335 3.5.2022 29.4.2022 Seebri Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/788 3.5.2022 29.4.2022 Spherox CO.DON AG Warthestraße 21, 14513 Teltow, Deutschland EU/1/17/1181 2.5.2022 29.4.2022 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle Del Principe De Vergara 132 Plt 12, 28002 Madrid, España EU/1/20/1507 29.4.2022 29.4.2022 Tovanor Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/790 3.5.2022 29.4.2022 Trevicta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/971 2.5.2022 29.4.2022 Vosevi Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/17/1223 3.5.2022 29.4.2022 Xevudy GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/21/1562 29.4.2022

— 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 13.4.2022 Pramipexole Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/11/728 19.4.2022 25.4.2022 Docetaxel Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/07/384 26.4.2022 29.4.2022 Starlix Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/174 3.5.2022

— 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 19.4.2022 Chanaxin tulathromycin Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/22/283 Solution for injection Pending 21.4.2022 19.4.2022 RenuTend tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/22/282 Suspension for injection QM09AX90 22.4.2022

— 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 4.4.2022 LETIFEND LETI Pharma, S.L.U. C/Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760 Madrid, España EU/2/16/195 6.4.2022 6.4.2022 CYTOPOINT Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/205 11.4.2022 6.4.2022 RESPIPORC FLUpan H1N1 Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/17/209 7.4.2022 13.4.2022 Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/07/079 20.4.2022 19.4.2022 SevoFlo Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/02/035 21.4.2022 26.4.2022 Credelio Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/17/206 28.4.2022 26.4.2022 CYTOPOINT Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/205 3.5.2022 26.4.2022 RESPIPORC FLUpan H1N1 Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/17/209 2.5.2022 26.4.2022 Zulvac BTV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/207 27.4.2022

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.