EMEA-002795-PIP01-20 - paediatric investigation plan

Respiratory Syncytial Virus stabilised prefusion f subunit vaccine (RSVpreF)

Key facts

• Active substance:
  Respiratory Syncytial Virus stabilised prefusion f subunit vaccine (RSVpreF)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0202/2021
• PIP number:
  EMEA-002795-PIP01-20
• 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 via maternal immunisation
• 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:
  10/05/2021
• Compliance check done:
  No

Decision

P/0202/2021 : EMA decision of 10 May 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for respiratory syncytial virus stabilised prefusion f subunit vaccine...(EMEA-002795-PIP01-20)

Adopted Reference Number: EMA/193790/2021