MHRA-100235-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Sotrovimab
Invented Name
Xevudy
PIP Number MHRA-100235-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection/infusion
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of coronavirus disease 2019 (COVID-19)
Route(s) of administration
  • Intravenous use
  • Intramuscular and intravenous 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):Sotrovimab.pdf
Published Date 03/12/2021