Inaqovi (cedazuridine;decitabine)
- Region
- 🇪🇺 EU
- Active substance
- cedazuridine;decitabine
- Company
- Otsuka Pharmaceutical Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid
- CHMP opinion
- Thu 20 Jul 2023
- EU approval
- Fri 15 Sep 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005823
- ATC
- L01BC58
- Official record
- www.ema.europa.eu
Indication
Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy. Inaqovi in combination with venetoclax is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
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.