EMEA-002440-PIP01-18-M05 - paediatric investigation plan

Baloxavir marboxil

Key facts

• Invented name:
  Xofluza
• Active substance:
  Baloxavir marboxil
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0359/2023
• PIP number:
  EMEA-002440-PIP01-18-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules for oral suspension
• Condition(s) / indication(s):
  • Prevention of influenza infection
  • Treatment of influenza
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0359/2023: EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for baloxavir marboxil (Xofluza), (EMEA-002440-PIP01-18-M05)

Adopted Reference Number: EMA/347368/2023