EMA
- Application: EMEA/H/C/004324
- Marketing authorisation holder: Celgene Europe BV
- Local brand name: Idhifa
- Indication: Treatment of acute myeloid leukaemia (AML)
- Status: withdrawn
🇪🇺 Idhifa in European Union
Idhifa (ENASIDENIB) regulatory status in European Union.
Marketing authorisation
Idhifa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Idhifa approved in European Union?
Yes. EMA has authorised it.
Who is the marketing authorisation holder for Idhifa in European Union?
Celgene Europe BV holds the EU marketing authorisation.