EMEA-002597-PIP04-21-M01 - paediatric investigation plan

Efgartigimod alfa

Key facts

• Invented name:
  Vyvgart
• Active Substance:
  Efgartigimod alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0252/2023
• PIP number:
  EMEA-002597-PIP04-21-M01
• Pharmaceutical form(s):
  • Solution for injection
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of immune thrombocytopenia
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2023

Decision

P/0252/2023 : EMA decision of 14 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for efgartigimod alfa (Vyvgart), (EMEA-002597-PIP04-21-M01)

Reference Number: EMA/303410/2023