EMEA-002966-PIP01-21 - paediatric investigation plan

Etesevimab

Key facts

• Active substance:
  Etesevimab
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0214/2021
• PIP number:
  EMEA-002966-PIP01-21
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/06/2021
• Compliance check done:
  Nej

Decision

P/0214/2021: EMA decision of 9 June 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for etesevimab (EMEA-002966-PIP01-21)

Reference Number: EMA/245824/2021