EMEA-003185-PIP01-22 - paediatric investigation plan

MVA-BN-RSV vaccine (construct MVA-mBN294B)

Key facts

• Active Substance:
  MVA-BN-RSV vaccine (construct MVA-mBN294B)
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0305/2023
• PIP number:
  EMEA-003185-PIP01-22
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of lower respiratory tract disease caused by respiratory syncytial virus
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/08/2023

Decision

P/0305/2023 : EMA decision of 11 August 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for MVA-BN-RSV vaccine (construct MVA-mBN294B), (EMEA-003185-PIP01-22)

Reference Number: EMA/336632/2023

MVA-BN-RSV (construct MVA-mBN294B) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision