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
授权状态Authorised
ATC编码A10BK01
是否额外监管no
是否仿制药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
批准上市日期2023/03/24
上市许可持有人/公司名称Viatris Limited
人用药物治疗分组Drugs used in diabetes
审评意见发布日期2023/01/26
修订号
适应症Type 2 diabetes mellitusDapagliflozin 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 failureDapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.Chronic kidney diseaseDapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.
首次发布日期2023/01/24
修订日期2023/04/04
产品信息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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