XOFLUZA (Roche Products Pty Ltd)
Product name
XOFLUZA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
161 working days (255)
Active ingredients
baloxavir marboxil
Registration type
NCE/NBE
Indication
XOFLUZA (film-coated tablet) is indicated for the treatment of uncomplicated influenza in patients aged 12 years of age and older who have been symptomatic for no more than 48 hours and who are:
- otherwise healthy, or
- at high risk of developing influenza complications.