EMEA-002961-PIP01-21-M01 - paediatric investigation plan

Regdanvimab

Key facts

• Invented name:
  Regkirona
• Active Substance:
  Regdanvimab
• Therapeutic area:
  Vaccines
• Decision number:
  P/0166/2022
• PIP number:
  EMEA-002961-PIP01-21-M01
• 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
• Contact for public enquiries:

  Celltrion Healthcare Hungary Kft.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/05/2022

Decision

P/0166/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for regdanvimab (Regkirona), (EMEA-002961-PIP01-21-M01)

AdoptedReference Number: EMA/204850/2022