EMEA-001856-PIP02-16-M02 - paediatric investigation plan

peramivir

Key facts

• Invented name:
  Alpivab
• Active substance:
  peramivir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0257/2021
• PIP number:
  EMEA-001856-PIP02-16-M02
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of influenza
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/07/2021
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-001856-PIP02-16-M02
• Compliance opinion date:
  17/12/2021
• Compliance outcome:
  Positive

Decision

P/0257/2021: EMA decision of 7 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for peramivir (EMEA-001856-PIP02-16-M02)

Adopted Reference Number: EMA/312393/2021