EMEA-001786-PIP01-15-M04 - paediatric investigation plan

Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)

Key facts

• Invented name:
  Ervebo
• Active substance:
  Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0315/2024
• PIP number:
  EMEA-001786-PIP01-15-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of ebola disease
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0315/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live) (Ervebo), (EMEA-001786-PIP01-15-M04)

Adopted Reference Number: EMA/410928/2024