EMEA-003133-PIP01-21-M01 - paediatric investigation plan

fidrisertib

Key facts

• Active substance:
  fidrisertib
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0360/2024
• PIP number:
  EMEA-003133-PIP01-21-M01
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of fibrodysplasia ossificans progressiva
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

P/0360/2024 : EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for fidrisertib, (EMEA- 003133-PIP01-21-M01)

Adopted Reference Number: EMA/481452/2024