EMA/PE/0000231366 - paediatric investigation plan

efgartigimod alfa

Key facts

• Invented name:
  Vyvgart
• Active substance:
  efgartigimod alfa
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0298/2024
• PIP number:
  EMA/PE/0000231366
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/03/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000231366: EMA decision of 21 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for efgartigimod alfa (Vyvgart)

Adopted Reference Number: EMADOC-1700519818-1980436