EMEA-002487-PIP01-18 - paediatric investigation plan

omaveloxolone

Key facts

• Active substance:
  omaveloxolone
• Therapeutic area:
  Neurology
• Decision number:
  P/0204/2022
• PIP number:
  EMEA-002487-PIP01-18
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of Friedreich's ataxia
• Route(s) of administration:
  • Gastric use
  • Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/06/2022
• Compliance check done:
  Nie

Decision

P/0204/2022 : EMA decision on 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for omaveloxolone (EMEA-002487-PIP01-18)

Adopted Reference Number: EMA/275720/2022