EMEA-003587-PIP01-24 - paediatric investigation plan

trofinetide

Key facts

• Active substance:
  trofinetide
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0188/2024
• PIP number:
  EMEA-003587-PIP01-24
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of Rett syndrome
• Route(s) of administration:
  • Oral use
  • Gastroenteral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/06/2024
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-003587-PIP01-24
• Compliance opinion date:
  06/09/2024
• Compliance outcome:
  Positive

Decision

P/0188/2024: EMA decision of 14 June 2024 on the agreement of a paediatric investigation plan and on the granting of a waiver for trofinetide (EMEA-003587-PIP01-24)

Reference Number: EMA/251788/2024