EMEA-002597-PIP04-21 - paediatric investigation plan

Efgartigimod alfa

Key facts

• Active Substance:
  Efgartigimod alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0078/2022
• PIP number:
  EMEA-002597-PIP04-21
• 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
• Contact for public enquiries:

  argenx BV

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/03/2022

Decision

P/0078/2022 : EMA decision of 11 March 2022 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-PIP04-21)

AdoptedReference Number: EMA/65203/2022