MHRA-101265-PIP01-23

Key Facts

Active Substance
Active Substance:
  • efgartigimod alfa
Invented Name
  • Vyvgar
  • Vyvgart
  • Vyvgart
PIP Number MHRA-101265-PIP01-23
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of thyroid eye disease
Route(s) of administration
  • Intravenous use
  • SUBCUTANEOUS 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 24/06/2024