EMEA-002597-PIP08-22 - paediatric investigation plan

Efgartigimod alfa

Key facts

• Active substance:
  Efgartigimod alfa
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0208/2023
• PIP number:
  EMEA-002597-PIP08-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of dermatomycosis
  • Treatment of immune-mediated necrotising myopathy
  • Treatment of polymyositis (including antisynthetase syndrome)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/06/2023
• Compliance check done:
  No

Decision

P/0208/2023 : EMA decision of 14 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for efgartigimod alfa (EMEA-002597-PIP08-22)

Reference Number: EMA/253550/2023