EMEA-002961-PIP01-21-M02 - paediatric investigation plan

regdanvimab

Key facts

• Invented name:
  Regkirona
• Active substance:
  regdanvimab
• Therapeutic area:
  Vaccines
• Decision number:
  P/0238/2023
• PIP number:
  EMEA-002961-PIP01-21-M02
• 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:
  14/06/2023
• Compliance check done:
  Ne

Decision

P/0238/2023 : EMA decision of 14 June 2023on the acceptance of a modification of an agreed paediatric investigation plan for regdanvimab (Regkirona), (EMEA-002961-PIP01-21-M02)

Reference Number: EMA/236249/2023