Inaqovi - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

cedazuridine / decitabine

Opinion

On 23 April 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Inaqovi. The marketing authorisation holder for this medicinal product is Otsuka Pharmaceutical Netherlands B.V.

The CHMP adopted a new indication as follows:

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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

---

Note: New text in bold

CHMP post-authorisation summary of positive opinion for Inaqovi (VR-0000304730)

Adopted Reference Number: EMADOC-1700519818-3050557

Key facts

• Name of medicine:
  Inaqovi
• EMA product number:
  EMEA/H/C/005823
• Active substance:
  • cedazuridine
  • decitabine
• International non-proprietary name (INN) or common name:
  • cedazuridine
  • decitabine
• Therapeutic area (MeSH):
  Leukemia, Myeloid
• Anatomical therapeutical chemical (ATC) code:
  L01BC58
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  Otsuka Pharmaceutical Netherlands B.V.
• Date of opinion:
  23/04/2026
• Status:
  Positive