Dacogen (decitabine)
- Region
- 🇪🇺 EU
- Active substance
- decitabine
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid
- EU approval
- Thu 20 Sep 2012
- Application
- EMEA/H/C/002221
- ATC
- L01BC08
- Official record
- www.ema.europa.eu
Indication
Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Inaqovi Authorised · Otsuka Pharmaceutical Netherlands B.V.
Follow Dacogen
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.