MHRA-100604-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • REMDESIVIR
Invented Name
  • VEKLURY
  • VEKLURY
  • VEKLURY
PIP Number MHRA-100604-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of coronavirus disease 2019 (COVID-19)
Route(s) of administration
Route(s) of administration:
  • 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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100604-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):REMDESIVIR.pdf
Published Date 02/02/2023