EMEA-001693-PIP03-21 - paediatric investigation plan

reparixin

Key facts

• Active substance:
  reparixin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0210/2022
• PIP number:
  EMEA-001693-PIP03-21
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/06/2022
• Compliance check done:
  Não

Decision

P/0210/2022 : EMA decision of 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for reparixin (EMEA-001693-PIP03-21)

Reference Number: EMA/365815/2022