EMEA-002899-PIP01-20-M03 - paediatric investigation plan

sotrovimab

Key facts

• Invented name:
  Xevudy
• Active substance:
  sotrovimab
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0334/2024
• PIP number:
  EMEA-002899-PIP01-20-M03
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0334/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for sotrovimab (Xevudy), (EMEA-002899-PIP01-20-M03)

Reference Number: EMA/414031/2024