SAXENDA (Novo Nordisk Pharmaceuticals Pty Ltd)
Product name
SAXENDA
Date registered
Evaluation commenced
Decision date
Approval time
193 working days (255)
Active ingredients
liraglutide
Registration type
EOI
Indication
SAXENDA is now also 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.