EMEA-002965-PIP01-21-M02 - paediatric investigation plan

Imdevimab

Key facts

• Invented name:
  Ronapreve
• Active substance:
  Imdevimab
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0343/2022
• PIP number:
  EMEA-002965-PIP01-21-M02
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  • Prevention of Coronavirus disease 2019 (COVID-19)
  • Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/08/2022
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-002965-PIP01-21-M02
• Compliance opinion date:
  19/10/2024
• Compliance outcome:
  Positive

Decision

P/0343/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for imdevimab (Ronapreve) (EMEA-002965-PIP01-21-M02)

Adopted Reference Number: EMA/638306/2022