EMEA-002307-PIP01-17-M02 - paediatric investigation plan

Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine expressing the full length glycoprotein of the Ebola virus Mayinga variant [Ad26.ZEBOV]

Key facts

• Invented name:
  Zabdeno
• Active substance:
  Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine expressing the full length glycoprotein of the Ebola virus Mayinga variant [Ad26.ZEBOV]
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0307/2021
• PIP number:
  EMEA-002307-PIP01-17-M02
• Pharmaceutical form(s):
  Suspension 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:
  12/08/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-002307-PIP01-17-M02
• Compliance opinion date:
  24/06/2022
• Compliance outcome:
  Positive

Decision

P/0307/2021 : EMA decision of 12 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine....(EMEA-002307- PIP01-17-M02)

Adopted Reference Number: EMA/382553/2021