Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2022 to 31 December 2022 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2023-02-28
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








C_2023076EN.01000101.xml










28.2.2023   


EN


Official Journal of the European Union


C 76/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2022 to 31 December 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))
(2023/C 76/01)
—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected










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




29.4.2022


IPIQUE







Rotterdam Biologics B.V.




Cypresbaan 3, Kamer 207, Capelle aan den Ijssel, 2908 LT Rotterdam, Nederland






—


22.6.2022




—   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




25.1.2022


Samsca







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/09/539


11.2.2022




28.3.2022


Insulin lispro Sanofi







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1203


27.4.2022




28.3.2022


Tasigna







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/07/422


29.3.2022




28.3.2022


Ucedane







Eurocept International B.V.




Trapgans 5, 1244 RL Ankeveen, Nederland






EU/1/17/1202


22.4.2022




28.3.2022


Zyclara







Viatris Healthcare Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/12/783


29.3.2022




29.4.2022


Flixabi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/16/1106


4.5.2022




29.4.2022


Kymriah







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/18/1297


3.5.2022




29.4.2022


Sylvant







EUSA Pharma (Netherlands) B.V.




Beechavenue 54, 1119PW Schiphol-Rijk, Nederland






EU/1/14/928


17.5.2022




24.5.2022


Symkevi







Vertex Pharmaceuticals (Ireland) Limited




Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland






EU/1/18/1306


25.5.2022




30.5.2022


Caprelsa







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/11/749


21.6.2022




30.5.2022


Desloratadine Actavis







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/11/745


31.5.2022




14.6.2022


Cholib







Mylan IRE Healthcare Ltd




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland






EU/1/13/866


12.7.2022




14.6.2022


Dovprela







Mylan IRE Healthcare Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland






EU/1/20/1437


30.6.2022




14.6.2022


Ganfort







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/06/340


18.7.2022




21.6.2022


Xyrem







UCB Pharma S.A.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België






EU/1/05/312


1.7.2022




29.6.2022


Uplizna







Horizon Therapeutics Ireland DAC




70 St. Stephen’s Green, Dublin 2, D02 E2X4, Ireland






EU/1/21/1602


17.8.2022




15.7.2022


Ontruzant







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/17/1241


20.7.2022




22.7.2022


NEXPOVIO







Stemline Therapeutics B.V.




Basisweg 10, 1043 AP, Amsterdam, Noord-Holland, Nederland






EU/1/21/1537


26.7.2022




25.7.2022


Bonviva







Atnahs Pharma Netherlands B.V.




Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark






EU/1/03/265


8.8.2022




12.8.2022


Adakveo







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/20/1476


9.9.2022




17.8.2022


Truxima







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország






EU/1/16/1167


18.9.2022




17.8.2022


Yescarta







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/18/1299


19.9.2022




19.9.2022


VeraSeal







Instituto Grifols, S.A.




Can Guasc, 2 — Parets del Vallès, 08150 Barcelona, Espaňa






EU/1/17/1239


21.9.2022




29.9.2022


Emtricitabine/Tenofovir disoproxil Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/16/1151


12.12.2022




29.9.2022


Lenalidomide Krka d.d.







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/20/1521


19.1.2023




29.9.2022


Menveo







GSK Vaccines S.r.l.




Via Fiorentina 1, 53100 Siena, Italia






EU/1/10/614


12.10.2022




9.11.2022


Ocaliva







ADVANZ PHARMA Limited




Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland






EU/1/16/1139


11.11.2022




28.11.2022


Dimethyl fumarate Mylan







Mylan Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland






EU/1/22/1634


6.12.2022




16.12.2022


Abiraterone Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/21/1553


17.1.2023




16.12.2022


Evoltra







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/06/334


26.1.2023




16.12.2022


Praluent







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/15/1031


19.12.2022




—   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




19.5.2022


Tulaven







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/20/251


27.6.2022




3.6.2022


Aivlosin







ECO Animal Health Europe Limited




6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland






EU/2/04/044


14.7.2022




14.6.2022


MS-H vaccine







Pharmsure Veterinary Products Europe Limited




4 Fitzwilliam Terrace, Strand Road, Bray, WICKLOW A98 T6H6, Ireland






EU/2/11/126


19.7.2022




15.7.2022


Exzolt







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/212


19.7.2022




22.7.2022


Felpreva







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/21/277


9.8.2022




22.7.2022


Suvaxyn Circo







Zoetis Belgium




rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique






EU/2/17/223


2.8.2022




22.7.2022


Ypozane







VIRBAC S.A.




1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France






EU/2/06/068


23.8.2022




30.11.2022


Bovela







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/14/176


1.12.2022




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.