EMEA-002826-PIP01-20-M04 - paediatric investigation plan

remdesivir

Key facts

• Invented name:
  Veklury
• Active substance:
  remdesivir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0439/2023
• PIP number:
  EMEA-002826-PIP01-20-M04
• 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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/10/2023
• Compliance check done:
  Jah
• Compliance procedure number:
  EMEA-C-002826-PIP01-20-M04
• Compliance opinion date:
  15/12/2023
• Compliance outcome:
  Positive

Decision

P/0439/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for remdesivir (Veklury), (EMEA-002826-PIP01-20-M04)

Reference Number: EMA/401499/2023