欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Glubrava
适用类别Human
治疗领域Diabetes Mellitus, Type 2
通用名/非专利名称pioglitazone;metformin
活性成分metformin hydrochloride;pioglitazone hydrochloride
产品号EMEA/H/C/000893
患者安全信息No
许可状态Withdrawn
ATC编码A10BD05
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2007/12/11
上市许可开发者/申请人/持有人Takeda Pharma A/S
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2021/02/04
修订号19
治疗适应症Glubrava is indicated as second line treatment of type-2-diabetes-mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
适用物种
兽用药物ATC编码
首次发布日期2017/11/10
最后更新日期2022/10/18
产品说明书https://www.ema.europa.eu/en/documents/product-information/glubrava-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/glubrava
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