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)
Date: 2022-04-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2022176EN.01000101.xml










29.4.2022   


EN


Official Journal of the European Union


C 176/1






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.