EMEA-002440-PIP01-18-M03

Table of contents

Key facts

Invented name
Xofluza
Active substance
Baloxavir marboxil
Therapeutic area
Infectious diseases
Decision number
P/0383/2022
PIP number
EMEA-002440-PIP01-18-M03
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. +41 6169 79411
E-mail: global.paediatrics@roche.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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