EMEA-001693-PIP02-20 - paediatric investigation plan

reparixin

Key facts

• Active substance:
  reparixin
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0188/2021
• PIP number:
  EMEA-001693-PIP02-20
• Pharmaceutical form(s):
  • Tablet
  • Solution for infusion
• Condition(s) / indication(s):
  Treatment of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  07/05/2021
• Compliance check done:
  No

Decision

P/0188/2021 : EMA decision of 7 May 2021 on the refusal of a product specific waiver for reparixin (EMEA-001693-PIP02-20)

Adopted Reference Number: EMA/193163/2021