欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Trajenta
适用类别Human
治疗领域Diabetes Mellitus, Type 2
通用名/非专利名称linagliptin
活性成分linagliptin
产品号EMEA/H/C/002110
患者安全信息No
许可状态Authorised
ATC编码A10BH05
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2011/08/23
上市许可开发者/申请人/持有人Boehringer Ingelheim International GmbH
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2025/01/24
修订号22
治疗适应症Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults: as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. as combination therapy in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
适用物种
兽用药物ATC编码
首次发布日期2018/06/26
最后更新日期2025/01/28
产品说明书https://www.ema.europa.eu/en/documents/product-information/trajenta-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/trajenta
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