欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Mounjaro
适用类别Human
治疗领域Diabetes Mellitus, Type 2;Obesity;Overweight
通用名/非专利名称tirzepatide
活性成分tirzepatide
产品号EMEA/H/C/005620
患者安全信息No
许可状态Authorised
ATC编码A10BX16
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2022/09/15
上市许可开发者/申请人/持有人Eli Lilly Nederland B.V.
人用药物治疗学分组Drugs used in diabetes
兽用药物治疗学分组
审评意见日期2022/07/21
欧盟委员会决定日期2025/10/23
修订号18
治疗适应症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).
适用物种
兽用药物ATC编码
首次发布日期2022/07/18
最后更新日期2025/12/11
产品说明书https://www.ema.europa.eu/en/documents/product-information/mounjaro-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro
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