EMEA-003636-PIP01-24 - paediatric investigation plan

respiratory syncytial virus, prefusion F protein, virus-like particle / human metapneumovirus, prefusion F protein, virus-like particle (IVX-A12)

Key facts

• Active substance:
  respiratory syncytial virus, prefusion F protein, virus-like particle / human metapneumovirus, prefusion F protein, virus-like particle (IVX-A12)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0001/2025
• PIP number:
  EMEA-003636-PIP01-24
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Prevention of lower respiratory tract disease caused by human metapneumovirus
  • 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:
  28/01/2025
• Compliance check done:
  No

Decision

P/0001/2025 : EMA decision of 28 January 2025 on agreement of PIP and on granting of deferral and waiver for respiratory syncytial virus, prefusion F protein, virus-like particle / human metapneumovirus, prefusion F protein, virus-like particle (IVX-A12)

Adopted Reference Number: EMA/22215/2025