EMEA-002308-PIP01-17-M02 - paediatric investigation plan

Multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine, expressing the EBOV Mayinga glycoprotein, the Sudan virus Gulu GP, the Marburg virus Musoke GP, and the Taï Forest virus nucleoprotein [MVA-BN-Filo]

Key facts

• Invented name:
  Mvabea
• Active Substance:
  Multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine, expressing the EBOV Mayinga glycoprotein, the Sudan virus Gulu GP, the Marburg virus Musoke GP, and the Taï Forest virus nucleoprotein [MVA-BN-Filo]
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0334/2021
• PIP number:
  EMEA-002308-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:
  19/08/2021
• Compliance procedure number:
  EMEA-C-002308-PIP01-17-M02
• Compliance opinion date:
  24/06/2022
• Compliance outcome:
  Positive

Decision

P/0334/2021 : EMA decision of 19 August 2021 on acceptance of a modification of an agreed paediatric investigation plan for multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine (EMEA-002308-PIP01-17)

AdoptedReference Number: EMA/382663/2021