MOUNJARO (Eli Lilly Australia Pty Ltd)
Product name
MOUNJARO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
191 (255 working days)
Active ingredients
tirzepatide
Registration type
EOI
Indication
Chronic Weight Management
MOUNJARO is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management, including weight loss and weight maintenance, in adults with an initial body mass index (BMI) of:
≥30 kg/m2 (obesity) or
≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes or type 2 diabetes mellitus).