MHRA-100197-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
Invented Name
ERVEBO
PIP Number MHRA-100197-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of Ebola disease
Route(s) of administration
Route(s) of administration:
  • Intramuscular 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 opinion date
23/08/2022
Compliance Check Procedure Number
Compliance procedure number
MHRA-100197-PIP01-21-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Ebola Zaire Vaccine (rVSV?G-ZEBOV-GP, live).pdf
Published Date 27/09/2022