欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Dapagliflozin Viatris
适用类别Human
治疗领域Diabetes Mellitus, Type 2;Heart Failure, Systolic;Heart Failure;Renal Insufficiency, Chronic
通用名/非专利名称dapagliflozin
活性成分dapagliflozin
产品号EMEA/H/C/006006
患者安全信息No
许可状态Authorised
ATC编码A10BK01
是否额外监管No
是否仿制药或hybrid药物Yes
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2023/03/24
上市许可开发者/申请人/持有人Viatris Limited
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2023/01/26
欧盟委员会决定日期2024/11/20
修订号4
治疗适应症Type 2 diabetes mellitus Dapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Dapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Chronic kidney disease Dapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.
适用物种
兽用药物ATC编码
首次发布日期2023/01/24
最后更新日期2024/11/21
产品说明书https://www.ema.europa.eu/en/documents/product-information/dapagliflozin-viatris-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/dapagliflozin-viatris
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