EMEA-003404-PIP01-23 - paediatric investigation plan

decitabine

tetrahydrouridine

Key facts

• Active substance:
  • decitabine
  • tetrahydrouridine
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0481/2023
• PIP number:
  EMEA-003404-PIP01-23
• Pharmaceutical form(s):
  • Capsule, hard
  • Tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of sickle cell disease
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/12/2023
• Compliance check done:
  No

Decision

P/0481/2023 : EMA decision of 1 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for decitabine / tetrahydrouridine (EMEA-003404-PIP01-23)

Adopted Reference Number: EMA/498578/2023