EMEA-003394-PIP01-23 - paediatric investigation plan

Sevasemten

Key facts

• Active Substance:
  Sevasemten
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0179/2024
• PIP number:
  EMEA-003394-PIP01-23
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of dystrophinopathy
• 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:
  06/05/2024

Decision

P/0179/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sevasemten (EMEA-003394-PIP01-23)

Reference Number: EMA/105519/2024