Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 30 June 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2021-08-27
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_2021346EN.01000101.xml










27.8.2021   


EN


Official Journal of the European Union


C 346/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 30 June 2021
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2021/C 346/01)
—   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




11.1.2021


Pylobactell







Torbet Laboratories Ireland Limited




20 Holles Street, Dublin 2, Ireland






EU/1/98/064


30.4.2021




22.1.2021


Cholib







Mylan IRE Healthcare Ltd




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






EU/1/13/866


30.4.2021




11.2.2021


Flixabi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/16/1106


30.3.2021




18.2.2021


Renvela







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/09/521


22.2.2021




9.3.2021


Diacomit







Biocodex




7 avenue Gallieni, 94250 Gentilly, France






EU/1/06/367


5.4.2021




9.3.2021


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/08/494


10.3.2021




26.3.2021


Grasustek







Juta Pharma GmbH




Gutenbergstr. 13, 24941, Flensburg, Deutschland






EU/1/19/1375


29.4.2021




26.3.2021


Memantine Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/13/827


30.4.2021




26.3.2021


Ranexa







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/08/462


13.4.2021




26.3.2021


Tepadina







ADIENNE S.r.l.S.U.




Via Galileo Galilei 19, 20867 Caponago (MB), Italia






EU/1/10/622


13.4.2021




26.3.2021


Xenical







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/98/071


14.4.2021




31.3.2021


Jinarc







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland






EU/1/15/1000


14.4.2021




21.4.2021


Azomyr







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/00/157


26.4.2021




21.4.2021


Lumigan







Allergan Pharmaceuticals Ireland




Castlebar Road, Westport, County Mayo, Ireland






EU/1/02/205


17.5.2021




21.4.2021


Mepact







Takeda France SAS




112 avenue Kléber, 75116 Paris, France






EU/1/08/502


18.5.2021




21.4.2021


Repatha







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1016


23.4.2021




21.4.2021


Samsca







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland






EU/1/09/539


12.5.2021




30.4.2021


Thymanax







Servier (Ireland) Industries Limited




Gorey Road, Arklow, Co. Wicklow, Ireland






EU/1/08/498


21.6.2021




19.5.2021


Clopidogrel Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/540


21.5.2021




19.5.2021


Emtricitabine/Tenofovir disoproxil Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1133


1.6.2021




19.5.2021


Grepid







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/09/535


20.5.2021




27.5.2021


Siklos







Addmedica




37 rue de Caumartin, 75009 Paris, France






EU/1/07/397


7.6.2021




—   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




26.3.2021


Crixivan







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/96/024


29.3.2021




—   Issuing 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


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




20.4.2021


Daxocox


Enflicoxib







Ecuphar NV




Legeweg 157-i, 8020 Oostkamp, België






EU/2/21/270


Tablet


QM01AH95


21.4.2021




—   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




26.4.2021


Palladia







Zoetis Belgium S.A.




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






EU/2/09/100


12.7.2021




9.6.2021


Equisolon







Le Vet B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/14/161


29.7.2021




22.6.2021


GUMBOHATCH







Laboratorios Hipra, S.A.




Avda. La Selva, 135, 17170 Amer (Girona), España






EU/2/19/245


28.6.2021




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.