EMA/PE/0000225023 - paediatric investigation plan

efgartigimod alfa

Key facts

• Active substance:
  efgartigimod alfa
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  EMA/PE/0000225023
• PIP number:
  EMA/PE/0000225023
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Sjögren's syndrome
• 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:
  03/01/2025
• Compliance check done:
  Nein

Decision

EMA/PE/0000225023 : EMA decision of 3 January 2025 on the granting of a product specific waiver for efgartigimod alfa (Vyvgart)

Adopted Reference Number: EMADOC-1700519818-1810349