EMEA-002904-PIP01-20-M01 - paediatric investigation plan

respiratory syncytial virus (RSV) PreF3 recombinant fusion protein/AS01 (RSVPreF3 OA)

Key facts

• Active substance:
  respiratory syncytial virus (RSV) PreF3 recombinant fusion protein/AS01 (RSVPreF3 OA)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0508/2023
• PIP number:
  EMEA-002904-PIP01-20-M01
• Pharmaceutical form(s):
  Powder and suspension for 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023
• Compliance check done:
  No

Decision

P/0508/2023: EMA decision of of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for respiratory syncytial virus (RSV) PreF3 recombinant fusion protein/AS01 (RSVPreF3 OA) (EMEA-002904-PIP01-20-M01)

Adopted Reference Number: EMA/554228/2023