MHRA-100050-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • efgartigimod alfa
Invented Name
  • Vyvgart
  • Vyvgart
PIP Number MHRA-100050-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of immune thrombocytopenia.
Route(s) of administration
  • intravenous
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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