MHRA-101265-PIP01-23

Key Facts

PIPS 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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):EFGARTIGIMOD ALFA.pdf
Published Date 24/06/2024