Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2020 to 31 December 2020 (Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2021-02-26
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_2021067EN.01000101.xml










26.2.2021   


EN


Official Journal of the European Union


C 67/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2020 to 31 December 2020
(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2021/C 67/01)
—   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




17.12.2020


Palforzia


defatted powder of Arachis hypogaea L., semen (peanuts)







Aimmune Therapeutics Ireland Limited




Block B, The Crescent Building, Northwood Crescent Northwood, Dublin 9, D09 C6X8 Ireland






EU/1/20/1495


White to beige oral powder in capsules for opening or sachet.


Pending


21.12.2020




—   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




3.8.2020


Urorec







Recordati Ireland Ltd




Raheens East, Ringaskiddy Co. Cork, Ireland






EU/1/09/608


14.8.2020




24.9.2020


Evoltra







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/06/334


15.10.2020




24.9.2020


Luminity







Lantheus EU Limited




Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare, V14 FW97, Ireland






EU/1/06/361


12.10.2020




24.9.2020


Matever







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/11/711


25.9.2020




22.10.2020


Zavicefta







Pfizer Ireland Pharmaceuticals




Operations Support Group, Ringaskiddy, County Cork, Ireland






EU/1/16/1109


19.11.2020




27.10.2020


Fabrazyme







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/01/188


13.11.2020




27.10.2020


TRISENOX







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/02/204


29.10.2020




5.11.2020


Elaprase







Shire Human Genetic Therapies AB




Vasagatan 7, 111 20 Stockholm, Sverige






EU/1/06/365


12.2.2021




16.11.2020


Ondexxya







Alexion Europe SAS




103-105 Rue Anatole France, 92300 Levallois-Perret, France






EU/1/18/1345


4.12.2020




20.11.2020


Fampyra







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/11/699


4.12.2020




20.11.2020


Humira







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/03/256


23.11.2020




25.11.2020


Triumeq







ViiV Healthcare BV




Huis ter Heideweg 62, 3705 LZ Zeist, Nederland






EU/1/14/940


7.12.2020




9.12.2020


Caprelsa







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/11/749


21.1.2021




14.12.2020


Efient







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/08/503


16.12.2020




14.12.2020


Hulio







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/18/1319


15.12.2020




14.12.2020


Revolade







Novartis Europharm Limited




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






EU/1/10/612


13.12.2020




14.12.2020


Thyrogen







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/99/122


17.12.2020




14.12.2020


Tolucombi







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/13/821


17.12.2020




17.12.2020


Chenodeoxycholic acid Leadiant







Leadiant GmbH




Liebherrstr. 22, 80538 Munich, Deutschland






EU/1/16/1110


15.1.2021




17.12.2020


Darunavir Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/17/1249


21.1.2021




—   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




30.10.2020


Meloxidolor







Le Vet Beheer B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/13/148


3.11.2020




20.11.2020


Cepedex







CP Pharma Handelsgesellschaft mbH




Ostlandring 13, 31303 Burgdorf, Deutschland






EU/2/16/200


21.12.2020




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.