EMEA-002899-PIP01-20-M01 - paediatric investigation plan

Sotrovimab

Key facts

• Invented name:
  • Xevudy
  • Xevudy
• Active Substance:
  Sotrovimab
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0468/2021
• PIP number:
  EMEA-002899-PIP01-20-M01
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection/infusion
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  • Intravenous use
  • Intramuscular use
• Contact for public enquiries:

  GlaxoSmithKline Trading Services Ltd

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/11/2021

Decision

P/0468/2021: EMA decision of 12 November 2021 on the acceptance of a modification of an agreed paediatric investigation plan for sotrovimab (EMEA-002899-PIP01-20-M01)

Reference Number: EMA/627431/2021