EMEA-003071-PIP01-21-M01 - paediatric investigation plan

cedazuridine

decitabine

Key facts

• Invented name:
  Inaqovi
• Active substance:
  • cedazuridine
  • decitabine
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0124/2024
• PIP number:
  EMEA-003071-PIP01-21-M01
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of acute myeloid leukaemia
• Route(s) of administration:
  • Gastric use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/04/2024
• Compliance check done:
  No

Decision

P/0124/2024: EMA decision of 11 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for cedazuridine / decitabine (Inaqovi) (EMEA-003071-PIP01-21-M01)

Reference Number: EMA/143924/2024