EMEA-002440-PIP01-18-M04 - paediatric investigation plan

Baloxavir marboxil

Key facts

• Invented name:
  Xofluza
• Active Substance:
  Baloxavir marboxil
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0098/2023
• PIP number:
  EMEA-002440-PIP01-18-M04
• 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
• Contact for public enquiries:

  Roche Registration GmbH

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0098/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for baloxavir marboxil, (Xofluza), (EMEA-002440-PIP01-18-M04)

Reference Number: EMA/66787/2023