EMEA-002795-PIP02-21-M01 - paediatric investigation plan

Respiratory syncytial virus stabilised prefusion F subunit vaccine

Key facts

• Active Substance:
  Respiratory syncytial virus stabilised prefusion F subunit vaccine
• Therapeutic area:
  Vaccines
• Decision number:
  P/0058/2023
• PIP number:
  EMEA-002795-PIP02-21-M01
• 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:
  24/01/2023

Decision

P/0058/2023 : EMA decision of 24 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for respiratory syncytial virus stabilised prefusion F subunit vaccine (EMEA-002795-PIP02-21-M01)

AdoptedReference Number: EMA/36508/2023