欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Ebymect
适用类别Human
治疗领域Diabetes Mellitus, Type 2
通用名/非专利名称dapagliflozin;metformin
活性成分dapagliflozin propanediol monohydrate;metformin hydrochloride
产品号EMEA/H/C/004162
患者安全信息No
许可状态Authorised
ATC编码A10BD15
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2015/11/15
上市许可开发者/申请人/持有人AstraZeneca AB
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2015/09/23
欧盟委员会决定日期2025/05/08
修订号23
治疗适应症Type 2 diabetes mellitus 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 and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. Type 1 diabetes mellitus Edistride is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ? 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
适用物种
兽用药物ATC编码
首次发布日期2017/12/20
最后更新日期2025/12/18
产品说明书https://www.ema.europa.eu/en/documents/product-information/ebymect-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/ebymect
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase