Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vyxeos   
Auth. number : EU/1/18/1308
Active substance : daunorubicin / cytarabine
Orphan market exclusivity for "Treatment of acute myeloid leukaemia" (based on designation EU/3/11/942) started on 27/08/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 27/08/2028
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XY - Combinations of cytostatics
Chemical substance: L01XY01 - cytarabine and daunorubicin
(See WHO ATC Index)
Indication: Vyxeos is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Marketing Authorisation Holder: Jazz Pharmaceuticals Ireland Ltd
5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/08/2018 Centralised - Authorisation EMEA/H/C/4282 (2018)5695 of 23/08/2018