EMA/PE/0000227151 - paediatric investigation plan

vidofludimus calcium

Key facts

• Active substance:
  vidofludimus calcium
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000227151
• PIP number:
  EMA/PE/0000227151
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/04/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000227151: EMA decision of 14 April 2025 on the granting of a product specific waiver for vidofludimus calcium

Adopted Reference Number: EMADOC-1700519818-2035630