欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Onglyza
适用类别Human
治疗领域Diabetes Mellitus, Type 2
通用名/非专利名称saxagliptin
活性成分saxagliptin
产品号EMEA/H/C/001039
患者安全信息No
许可状态Authorised
ATC编码A10BH03
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2009/09/30
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
欧盟委员会决定日期2023/04/19
修订号23
治疗适应症Add-on combination therapy Onglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate; as triple oral therapy: in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control; as combination therapy 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2017/08/17
最后更新日期2024/05/13
产品说明书https://www.ema.europa.eu/en/documents/product-information/onglyza-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/onglyza
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