| 商品名称 | Vildagliptin / Metformin hydrochloride Accord |
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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 | vildagliptin;metformin hydrochloride |
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| 活性成分 | metformin hydrochloride;vildagliptin |
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| 产品号 | EMEA/H/C/005738 |
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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 | A10BD08 |
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| 是否额外监管 | Yes |
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| 是否仿制药或hybrid药物 | Yes |
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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 | 2022/03/24 |
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| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
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| 人用药物治疗学分组 | Drugs used in diabetes |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2021/12/16 |
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| 欧盟委员会决定日期 | 2025/07/25 |
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| 修订号 | 4 |
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| 治疗适应症 | Vildagliptin/Metformin hydrochloride Accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). |
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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 | 2021/12/14 |
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| 最后更新日期 | 2025/07/25 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/vildagliptin/metformin-hydrochloride-accord-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/vildagliptin-metformin-hydrochloride-accord |
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