EMEA-001784-PIP01-15-M04 - paediatric investigation plan

nirsevimab

Key facts

• Invented name:
  Beyfortus
• Active substance:
  nirsevimab
• Therapeutic area:
  Vaccines
• Decision number:
  P/0296/2021
• PIP number:
  EMEA-001784-PIP01-15-M04
• Pharmaceutical form(s):
  Solution 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:
  08/07/2022
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001784-PIP01-15-M04
• Compliance opinion date:
  13/10/2023
• Compliance outcome:
  Positive

Decision

P/0243/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for nirsevimab (EMEA-001784-PIP01-15-M04)

Reference Number: EMA/602323/2022