EMEA-002970-PIP01-21 - paediatric investigation plan

tildacerfont

Key facts

• Active substance:
  tildacerfont
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0036/2022
• PIP number:
  EMEA-002970-PIP01-21
• Pharmaceutical form(s):
  • Granules
  • Tablet
• Condition(s) / indication(s):
  Treatment of congenital adrenal hyperplasia
• 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:
  31/01/2022
• Compliance check done:
  No

Decision

P/0036/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tildacerfont (EMEA-002970-PIP01-21)

Adopted Reference Number: EMA/9505/2022