EMA/PE/0000232762 - paediatric investigation plan

frexalimab

Key facts

• Active substance:
  frexalimab
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000232762
• PIP number:
  EMA/PE/0000232762
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/04/2025
• Compliance check done:
  Nē

Decision

EMA/PE/0000232762: EMA decision of 14 April 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for frexalimab

Adopted Reference Number: EMADOC-1700519818-2036382