BENEDO (Sun Pharma ANZ Pty Ltd)
Product name
BENEDO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
188 (255 working days)
Active ingredients
Liraglutide
Registration type
NCE/ NBE
Indication
LIRAGLUTIDE RBX / LIRAGLUTIDE SUN / BENEDO is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of
- ≥30 kg/m2 (obese) or
- ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.
Treatment with LIRAGLUTIDE RBX / LIRAGLUTIDE SUN / BENEDO should be discontinued after 12 weeks on the 3.0 mg/day dose if a patient has not lost at least 5% of their initial body weight.