Vyxeos liposomal (previously Vyxeos) (daunorubicin;cytarabine)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- daunorubicin;cytarabine
- Company
- Jazz Pharmaceuticals Ireland Limited
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid, Acute
- CHMP opinion
- Thu 26 Apr 2018
- EU approval
- Thu 23 Aug 2018
- Designations
- Orphan
- Application
- EMEA/H/C/004282
- ATC
- L01XY01
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.