MHRA-100053-PIP01-21

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • REGN10987
Invented Name
Not Yet Available
PIP Number MHRA-100053-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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):REGN10987.pdf
Published Date 19/11/2021