EMEA-002597-PIP10-23 - paediatric investigation plan

Efgartigimod alfa

Key facts

• Invented name:
  Vyvgart
• Active substance:
  Efgartigimod alfa
• Therapeutic area:
  Eye disorders
• Decision number:
  P/0111/2024
• PIP number:
  EMEA-002597-PIP10-23
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of thyroid eye disease
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/04/2024
• Compliance check done:
  No

Decision

P/0111/2024: EMA decision of 12 April 2024 on the granting of a product specific waiver for efgartigimod alfa (Vyvgart), (EMEA-002597-PIP10-23)

Adopted Reference Number: EMA/105466/2024