欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Avandia
适用类别Human
治疗领域Diabetes Mellitus, Type 2
通用名/非专利名称rosiglitazone
活性成分rosiglitazone
产品号EMEA/H/C/000268
患者安全信息No
许可状态Expired
ATC编码A10BG02
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2000/07/11
上市许可开发者/申请人/持有人SmithKline Beecham Plc
人用药物治疗学分组Drugs used in diabetes
兽用药物治疗学分组
欧盟委员会决定日期2010/12/03
修订号23
治疗适应症Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus: as monotherapy-in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with-metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin-a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea as triple oral therapy in combination with-metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).
适用物种
兽用药物ATC编码
首次发布日期2010/12/03
最后更新日期2016/06/08
产品说明书https://www.ema.europa.eu/en/documents/product-information/avandia-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/avandia
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