EMEA-001238-PIP03-21-M01 - paediatric investigation plan

vatiquinone

Key facts

• Active substance:
  vatiquinone
• Therapeutic area:
  Neurology
• Decision number:
  P/0192/2023
• PIP number:
  EMEA-001238-PIP03-21-M01
• Pharmaceutical form(s):
  • Oral solution
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of Friedreich's ataxia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  26/05/2023
• Compliance check done:
  No

Decision

P/0192/2023 : EMA decision of 26 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for vatiquinone (EMEA-001238-PIP03-21-M01)

Adopted Reference Number: EMA/186780/2023