MHRA-100917-PIP01-23

Key Facts

Active Substance
Active Substance:
  • efgartigimod alfa
Invented Name
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
PIP Number MHRA-100917-PIP01-23
Pharmaceutical form(s)
  • Solution for injection
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of Bullous Pemphigoid
Route(s) of administration
  • Subcutaneous use
  • INTRAVENOUS USE
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):efgartigimod alfa.pdf
Published Date 19/12/2023