Basic Information
Mounjaro
Regulatory Information
EMEA/H/C/005620
September 15, 2022
July 21, 2022
15
October 25, 2024
Company Information
the netherlands
Papendorpseweg 83 3528 BJ Utrecht
Eli Lilly Nederland BV
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **Type 2 diabetes mellitus** Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise \- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications \- in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1. **Weight management** Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for 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).
Overview Summary
Mounjaro is a medicine used together with diet and physical activity to treat adults who have type 2 diabetes which is not satisfactorily controlled. It can be used on its own in patients who cannot take metformin (another diabetes medicine) or as an ‘add-on’ to other diabetes medicines. Mounjaro is also used together with diet and physical activity to help people to lose weight and keep their weight under control. It is used in people who have obesity (BMI of 30 kg/m2 or more) or who are overweight (BMI between 27 and 30 kg/m2) and have weight-related health problems such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep). BMI (body mass index) is a measure of your weight in relation to your height. Mounjaro contains the active substance tirzepatide.