EMEA-002700-PIP01-19-M02 - paediatric investigation plan

crinecerfont

Key facts

• Active substance:
  crinecerfont
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0278/2024
• PIP number:
  EMEA-002700-PIP01-19-M02
• Pharmaceutical form(s):
  • Capsule, hard
  • Oral solution
• Condition(s) / indication(s):
  Treatment of congenital adrenal hyperplasia
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2024
• Compliance check done:
  Ei

Decision

P/0278/2024: EMA decision of 14 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for crinecerfont (EMEA-002700-PIP01-19-M02)

Adopted Reference Number: EMA/307240/2024