EMEA-001318-PIP01-12-M05 - paediatric investigation plan

zanamivir

Key facts

• Invented name:
  Relenza
• Active substance:
  zanamivir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0485/2023
• PIP number:
  EMEA-001318-PIP01-12-M05
• Pharmaceutical form(s):
  • Inhalation powder (pre-dispensed)
  • Solution for infusion
• Condition(s) / indication(s):
  • Prevention of influenza
  • Treatment of influenza
• Route(s) of administration:
  • Inhalation use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023
• Compliance check done:
  No

Decision

P/0485/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for zanamivir (Relenza), (EMEA-001318-PIP01-12-M05)

Adopted Reference Number: EMA/517349/2023