EMEA-002597-PIP05-21-M01 - paediatric investigation plan

Efgartigimod alfa

Key facts

• Invented name:
  Vyvgart
• Active substance:
  Efgartigimod alfa
• Therapeutic area:
  Neurology
• Decision number:
  P/0159/2023
• PIP number:
  EMEA-002597-PIP05-21-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/05/2023
• Compliance check done:
  No

Decision

P/0159/2023 : EMA decision of 12 May 2023 on on the acceptance of a modification of an agreed paediatric investigation plan for efgartigimod alfa (Vyvgart), (EMEA-002597-PIP05-21-M01)

Reference Number: EMA/170275/2023