EMEA-002597-PIP09-22 - paediatric investigation plan

Efgartigimod alfa

Key facts

• Invented name:
  Vyvgart
• Active Substance:
  Efgartigimod alfa
• Decision number:
  P/0013/2023
• PIP number:
  EMEA-002597-PIP09-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of bullous pemphigoid
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  argenx BV

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/03/2023

Decision

P/0013/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for efgartigimod alfa (Vyvgart), (EMEA-002597-PIP09-22)

AdoptedReference Number: EMA/18446/2023