EMEA-002826-PIP01-20-M03 - paediatric investigation plan

remdesivir

Key facts

• Invented name:
  Veklury
• Active Substance:
  remdesivir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0221/2022
• PIP number:
  EMEA-002826-PIP01-20-M03
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Gilead Sciences International Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/06/2022

Decision

P/0221/2022 : EMA decision of 24 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for remdesivir (Veklury), (EMEA-002826-PIP01-20-M03)

Reference Number: EMA/579337/2022