EMA — authorised 27 September 2010
- Application: EMEA/H/C/001197
- Marketing authorisation holder: Merck Serono Europe Limited
- Local brand name: Movectro
- Status: withdrawn
🇪🇺 DAC in European Union
EMA authorised DAC on 27 September 2010
Marketing authorisations
EMA — authorised 23 August 2018
- Application: EMEA/H/C/004282
- Marketing authorisation holder: Jazz Pharmaceuticals Ireland Limited
- Local brand name: Vyxeos liposomal (previously Vyxeos)
- Indication: Vyxeos liposomal 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).
- Pathway: orphan
- Status: approved
Other Oncology approved in European Union
Frequently asked questions
Is DAC approved in European Union?
Yes. EMA authorised it on 27 September 2010; EMA authorised it on 23 August 2018.
Who is the marketing authorisation holder for DAC in European Union?
Merck Serono Europe Limited holds the EU marketing authorisation.