EMEA-003094-PIP02-21 - paediatric investigation plan

RSV preF protein

Key facts

• Active substance:
  RSV preF protein
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0350/2022
• PIP number:
  EMEA-003094-PIP02-21
• 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:
  10/08/2023
• Compliance check done:
  No

Decision

P/0350/2022: EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for RSV preF protein (EMEA-003094-PIP02-21)

Reference Number: EMA/673786/2022