| 商品名称 | Komboglyze |
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| 适用类别 | Human |
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| 治疗领域 | Diabetes Mellitus, Type 2 |
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| 通用名/非专利名称 | saxagliptin;metformin hydrochloride |
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| 活性成分 | metformin hydrochloride;saxagliptin hydrochloride |
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| 产品号 | EMEA/H/C/002059 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | A10BD10 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2011/11/24 |
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| 上市许可开发者/申请人/持有人 | AstraZeneca AB |
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| 人用药物治疗学分组 | Drugs used in diabetes;Combinations of oral blood glucose lowering drugs |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2025/05/08 |
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| 修订号 | 23 |
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| 治疗适应症 | Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets. Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2017/06/26 |
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| 最后更新日期 | 2025/05/23 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/komboglyze-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/komboglyze |
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