EMEA-001786-PIP01-15-M03 - 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
  • Vaccines
• Decision number:
  P/0495/2023
• PIP number:
  EMEA-001786-PIP01-15-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of Ebola virus disease
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023

Decision

P/0495/2023: EMA decision of 1 December 2023 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-M03)

AdoptedReference Number: EMA/516932/2023