EMA/PE/0000229144 - paediatric investigation plan

Respiratory Syncytial Virus stabilised prefusion f subunit vaccine (RSVpreF)

Key facts

• Invented name:
  Abrysvo
• Active substance:
  Respiratory Syncytial Virus stabilised prefusion f subunit vaccine (RSVpreF)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0058/2023
• PIP number:
  EMA/PE/0000229144
• Pharmaceutical form(s):
  Powder and solvent for solution 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/03/2025
• Compliance check done:
  Nem

Decision

EMA/PE/0000229144: EMA decision of 21 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for respiratory syncytial virus stabilised prefusion F subunit vaccine (RSVpreF) (Abrysvo)

Adopted Reference Number: EMADOC-1700519818-1976219