MHRA-100050-PIP01-21

Key Facts

Active Substance
Active Substance:
  • efgartigimod alfa
Invented Name
Not yet available
PIP Number MHRA-100050-PIP01-21
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 use
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(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 17/05/2022