EMEA-002700-PIP01-19-M01 - paediatric investigation plan

Crinecerfont

Key facts

• Active Substance:
  Crinecerfont
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0097/2023
• PIP number:
  EMEA-002700-PIP01-19-M01
• Pharmaceutical form(s):
  • Capsule (hard)
  • Oral solution
• Condition(s) / indication(s):
  Treatment of congenital adrenal hyperplasia
• Route(s) of administration:
  • Oral use
  • Gastric use
• Contact for public enquiries:

  Neurocrine Therapeutics Ltd

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0097/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for crinecerfont (EMEA- 002700-PIP01-19-M01)

Reference Number: EMA/66788/2023