EMEA-002821-PIP01-20 - paediatric investigation plan

Respiratory Syncytial Virus PreF3 recombinant fusion protein (RSVPreF3)

Key facts

• Active Substance:
  Respiratory Syncytial Virus PreF3 recombinant fusion protein (RSVPreF3)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0098/2021
• PIP number:
  EMEA-002821-PIP01-20
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Prevention of RSV-associated lower respiratory tract illness through maternal immunisation
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  GlaxoSmithKline Biologicals SA

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/03/2021

Decision

P/0098/2021 : EMA decision of 19 March 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 PreF3 recombinant.......(EMEA-002821-PIP01-20)

Reference Number: EMA/73054/2021