MHRA-100052-PIP01-21

Key Facts

Active Substance
Active Substance:
  • REGN10933
Invented Name
Not Yet Available
PIP Number MHRA-100052-PIP01-21
Pharmaceutical form(s)
  • Solution for infusion
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
  • Intramuscular 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):REGN10933.pdf
Published Date 19/11/2021