EMEA-003553-PIP01-23 - paediatric investigation plan

oveporexton

Key facts

• Active substance:
  oveporexton
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMEA-003553-PIP01-23
• PIP number:
  EMEA-003553-PIP01-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Treatment of idiopathic hypersomnia
  • Treatment of narcolepsy
• 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:
  19/03/2025
• Compliance check done:
  Nem

Decision

EMEA-003553-PIP01-23: EMA decision of 19 March 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for oveporexton

Adopted Reference Number: EMADOC-1700519818-1944371