EMEA-003080-PIP03-22 - paediatric investigation plan

vilobelimab

Key facts

• Active substance:
  vilobelimab
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0118/2023
• PIP number:
  EMEA-003080-PIP03-22
• 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:
  13/04/2023
• Compliance check done:
  No

Decision

P/0118/2023 : EMA decision of 13 April 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for vilobelimab (EMEA-003080-PIP03-22)

Adopted Reference Number: EMA/103746/2023