Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2018 to 30 September 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-11-30
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2018433EN.01000101.xml










30.11.2018   


EN


Official Journal of the European Union


C 433/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2018 to 30 September 2018
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2018/C 433/01)






—



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




19.7.2018


Carmustine Obvius


carmustine


Obvius Investment B.V.
De Cuserstraat 93, 1081 CN Amsterdam, Nederland


EU/1/18/1278


Powder and solvent for concentrate for solution for infusion


L01AD01


23.7.2018










—



Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




20.9.2018


Dexxience


Portola Pharma UK Limited
209 Tower Bridge Business Centre, 46-48 East Smithfield, London E1W 1AW, United Kingdom


—


16.10.2018










—



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




30.1.2018


Emtricitabine/Tenofovir disoproxil Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/16/1133


1.2.2018




8.5.2018


Riluzole Zentiva


Zentiva k.s.
U kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/12/768


15.5.2018




19.7.2018


Taxespira


Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom


EU/1/15/1017


23.7.2018




26.7.2018


Defitelio


Gentium S.r.I.
Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia


EU/1/13/878


30.7.2018




26.7.2018


Mycamine


Astellas Pharma Europe B.V.
Sylviusweg 62, 2333 BE Leiden, Nederland


EU/1/08/448


30.7.2018




26.7.2018


Roteas


Daiichi Sankyo Europe GmbH
Zielstattstraße 48, 81379 München, Deutschland


EU/1/16/1152


30.9.2018




26.7.2018


Xeljanz


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/17/1178


30.7.2018




30.7.2018


Arava


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/99/118


9.8.2018










—



Issuing 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


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




1.2.2018


Oxybee


oxalic acid dihydrate


Dany Bienenwohl GmbH
Geyerspergerstraße 27, 80689 München, Deutschland


EU/2/17/216


Powder and solution for bee-hive dispersion


QP53AG03


5.2.2018




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




30 Churchill Place




Canary Wharf




London




E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.