MEA-002970-PIP01-21 - paediatric investigation plan

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Key facts

• Active Substance:
  Tildacerfont
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0036/2022
• PIP number:
  MEA-002970-PIP01-21
• Pharmaceutical form(s):
  • Tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of congenital adrenal hyperplasia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Spruce Biosciences, Inc.

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2022