EMEA-003277-PIP02-23 - paediatric investigation plan

live attenuated respiratory syncytial virus (RSV)

Key facts

• Active substance:
  live attenuated respiratory syncytial virus (RSV)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0153/2024
• PIP number:
  EMEA-003277-PIP02-23
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Prevention of respiratory syncytial virus disease
• Route(s) of administration:
  Nasal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/05/2024
• Compliance check done:
  No

Decision

P/0153/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for live attenuated respiratory syncytial virus (RSV) (EMEA-003277-PIP02-23)

Adopted Reference Number: EMA/148126/2024