EMA/PE/0000227425 - paediatric investigation plan

efgartigimod alfa

Key facts

• Invented name:
  Vyvgart
• Active substance:
  efgartigimod alfa
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  EMA/PE/0000227425
• PIP number:
  EMA/PE/0000227425
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of immune thrombocytopenia
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000227425 : 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-1700519818-1860426