EMA/PE/0000226957 - paediatric investigation plan

efgartigimod alfa

Key facts

• Invented name:
  Vyvgart
• Active substance:
  efgartigimod alfa
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000226957
• PIP number:
  EMA/PE/0000226957
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  Nein

Decision

EMA/PE/0000226957 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for efgartigimod alfa (Vyvgart)

Adopted Reference Number: EMADOC-1700519818-1840317