Official Journal of the European Union

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

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

(2022/C 176/01)

— 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 24.3.2022 Dasatinib Accord dasatinib Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/21/1540 Film-coated tablet L01EA02 25.3.2022 24.3.2022 Dasatinib Accordpharma dasatinib Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/21/1541 Film-coated tablet L01EA02 25.3.2022 24.3.2022 Sondelbay teriparatide Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/22/1628 Solution for injection H05AA02 25.3.2022 24.3.2022 Vildagliptin/Metformin hydrochloride Accord vildagliptin / metformin hydrochloride Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/21/1611 Film-coated tablet A10BD08 25.3.2022 28.3.2022 Stimufend pegfilgrastim Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/22/1632 Solution for injection L03AA13 29.3.2022

— 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 2.3.2022 COVID-19 Vaccine Janssen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1525 3.3.2022 2.3.2022 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle Monte Esquinza 30, 28010 Madrid, España EU/1/20/1507 3.3.2022 3.3.2022 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/930 4.3.2022 4.3.2022 Entecavir Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/17/1211 8.3.2022 4.3.2022 Ifirmasta KRKA d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/480 9.3.2022 4.3.2022 MAVENCLAD Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/17/1212 7.3.2022 4.3.2022 Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1089 7.3.2022 4.3.2022 Rubraca Clovis Oncology Ireland Limited Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland EU/1/17/1250 15.3.2022 4.3.2022 Rydapt Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/17/1218 7.3.2022 4.3.2022 Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 8.3.2022 4.3.2022 Vimpat UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/08/470 8.3.2022 4.3.2022 Xeljanz Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/17/1178 8.3.2022 4.3.2022 Zebinix Bial — Portela & Ca, SA À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal EU/1/09/514 7.3.2022 4.3.2022 Ziagen ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/99/112 8.3.2022 7.3.2022 Ronapreve Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/21/1601 8.3.2022 11.3.2022 Fulphila Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/18/1329 14.3.2022 18.3.2022 Dectova GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/18/1349 28.3.2022 18.3.2022 HALAVEN Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/11/678 23.3.2022 18.3.2022 Leflunomide Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/09/604 24.3.2022 18.3.2022 Soliris Alexion Europe SAS 103-105 rue Anatole France, 92300 Levallois-Perret, France EU/1/07/393 21.3.2022 18.3.2022 Telzir ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/04/282 21.3.2022 22.3.2022 Capecitabine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/761 24.3.2022 22.3.2022 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München, Deutschland EU/1/13/875 23.3.2022 22.3.2022 Glivec Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/198 23.3.2022 22.3.2022 Jinarc Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland EU/1/15/1000 25.3.2022 22.3.2022 Maviret AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/17/1213 23.3.2022 22.3.2022 Natpar Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/15/1078 23.3.2022 22.3.2022 Nemdatine Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/13/824 23.3.2022 22.3.2022 Repaglinide Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/530 24.3.2022 22.3.2022 Sprycel Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/06/363 23.3.2022 22.3.2022 Trepulmix SciPharm Sàrl 7, Fausermillen, 6689 Mertert, Luxembourg EU/1/19/1419 24.3.2022 22.3.2022 Zynteglo bluebird bio (Netherlands) B.V. Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland EU/1/19/1367 23.3.2022 24.3.2022 Aflunov Seqirus S.r.l. Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italy EU/1/10/658 25.3.2022 24.3.2022 Atectura Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1439 25.3.2022 24.3.2022 AYVAKYT Blueprint Medicines (Netherlands) B.V. Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland EU/1/20/1473 25.3.2022 24.3.2022 Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/12/802 25.3.2022 24.3.2022 Gliolan photonamic GmbH & Co. KG Eggerstedter Weg 12, 25421 Pinneberg, Deutschland EU/1/07/413 4.4.2022 24.3.2022 Lynparza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/959 25.3.2022 24.3.2022 Olanzapine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/427 4.4.2022 24.3.2022 Palynziq BioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland EU/1/19/1362 5.4.2022 24.3.2022 Recarbrio Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/19/1420 25.3.2022 24.3.2022 Rukobia ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/20/1518 25.3.2022 24.3.2022 TAGRISSO AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1086 25.3.2022 24.3.2022 Trimbow Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/17/1208 25.3.2022 24.3.2022 Veltassa Vifor Fresenius Medical Care Renal Pharma France 100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France EU/1/17/1179 29.3.2022 28.3.2022 Beovu Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/19/1417 29.3.2022 28.3.2022 Brineura BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/17/1192 6.4.2022 28.3.2022 Daurismo Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/20/1451 29.3.2022 28.3.2022 Delstrigo Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1333 30.3.2022 28.3.2022 Nexavar Bayer AG D-51368 Leverkusen, Deutschland EU/1/06/342 4.4.2022 28.3.2022 OBIZUR Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/15/1035 29.3.2022 28.3.2022 Ongentys Bial — Portela & Ca, SA À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal EU/1/15/1066 30.3.2022 28.3.2022 OXERVATE Dompé farmaceutici S.p.A. Via Santa Lucia 6, 20122 Milano, Italia EU/1/17/1197 30.3.2022 28.3.2022 PHEBURANE Eurocept International BV Trapgans 5, 1244 RL Ankeveen, Nederland EU/1/13/822 30.3.2022 28.3.2022 Vidaza Bristol Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/08/488 29.3.2022 31.3.2022 Bosulif Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/13/818 31.3.2022 31.3.2022 Vaxzevria AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1529 31.3.2022

— 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 22.3.2022 Zynquista Guidehouse Germany GmbH Albrechtstrasse 10c, 10117 Berlin, Deutschland EU/1/19/1363 24.3.2022 24.3.2022 Zynteglo bluebird bio (Netherlands) B.V. Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland EU/1/19/1367 29.3.2022

— 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 4.3.2022 Nobilis Influenza H5N2 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/06/061 7.3.2022 4.3.2022 Zolvix Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/09/101 8.3.2022 10.3.2022 EQUIOXX Audevard 37-39 Rue De Neuilly, 92110 Clichy, France EU/2/08/083 11.3.2022 10.3.2022 Kriptazen Virbac 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France EU/2/18/234 14.3.2022 10.3.2022 Vectormune ND CEVA-Phylaxia Co. Ltd Szállás u. 5, 1107 Budapest, Magyarország EU/2/15/188 12.3.2022 16.3.2022 Credelio Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/17/206 17.3.2022 16.3.2022 Nobivac Myxo-RHD Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/11/132 17.3.2022

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.