Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2020 to 31 August 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-10-30
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2020367EN.01000101.xml










30.10.2020   


EN


Official Journal of the European Union


C 367/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2020 to 31 August 2020
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2020/C 367/01)
—   Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




20.5.2020


Zeposia


ozanimod







Celgene Europe B.V.




Winthontlaan 6 N, 3526 KV Utrecht, Nederland






EU/1/20/1442


Capsule, hard


L04AA38


25.5.2020




—   Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




17.4.2020


Natpar







Shire Pharmaceuticals Ireland Limited




Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland






EU/1/15/1078


20.5.2020




23.4.2020


Cyanokit







SERB S.A.




Avenue Louise 480, 1050 Bruxelles, Belgique/Louizalaan 480, 1050 Brussel, België






EU/1/07/420


12.5.2020




23.4.2020


Oncaspar







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/15/1070


13.5.2020




28.4.2020


Miglustat Gen.Orph







Gen.Orph




185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France






EU/1/17/1232


4.6.2002




28.4.2020


NeuroBloc







Sloan Pharma S.a.r.l.




33 Rue de Puits Romain, 8070 Bertrange, Luxembourg






EU/1/00/166


19.5.2020




28.4.2020


Privigen







CSL Behring GmbH




Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland






EU/1/08/446


20.5.2020




22.6.2020


Avonex







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/97/033


17.7.2020




25.6.2020


Emtricitabine/Tenofovir disoproxil Krka d.d.







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/17/1182


20.7.2020




17.7.2020


Jentadueto







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/12/780


27.7.2020




17.7.2020


Zarzio







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/08/495


17.8.2020




27.7.2020


TOBI Podhaler







Mylan IRE Healthcare Ltd




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






EU/1/10/652


29.7.2020




31.7.2020


CABOMETYX







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/16/1136


6.8.2020




31.7.2020


Oprymea







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/08/469


13.8.2020




28.8.2020


Effentora







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/08/441


7.9.2020




28.8.2020


Olanzapine Glenmark







Glenmark Arzneimittel GmbH




Industriestr. 31, D — 82194 Gröbenzell, Deutschland






EU/1/09/587


9.9.2020




28.8.2020


Olanzapine Glenmark Europe







Glenmark Arzneimittel GmbH




Industriestr. 31, D — 82194 Gröbenzell, Deutschland






EU/1/09/588


9.9.2020




—   Suspension of a marketing authorization (Article 20 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 authorization


Number of the entry in the Community Register


Date of notification




25.3.2020


Ulipristal Acetate Gedeon Richter







Gedeon Richter Plc.




Gyömrői út 19-21., 1103 Budapest, Magyarország






EU/1/18/1309


27.3.2020




—   Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




24.4.2020


Suprelorin







VIRBAC S.A.




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






EU/2/07/072


20.5.2020




24.6.2020


Novaquin







Le Vet Beheer B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/15/186


20.7.2020




28.8.2020


Syvazul BTV







LABORATORIOS SYVA, S.A.U.




Av. Párroco Pablo Diez 49-57, 24010 León, España






EU/2/18/231


7.9.2020




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.