EMA/PE/0000243891 - paediatric investigation plan

azacitidine

cedazuridine

Key facts

• Active substance:
  • azacitidine
  • cedazuridine
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  EMA/PE/0000243891
• PIP number:
  EMA/PE/0000243891
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of myelodysplastic syndromes
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/06/2025
• Compliance check done:
  Non

Decision

EMA/PE/0000243891 : EMA decision of 13 June 2025 on the granting of a product specific waiver for azacitidine / cedazuridine

Adopted Reference Number: EMADOC-1700519818-2192435