| 商品名称 | Januvia |
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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 | sitagliptin |
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| 活性成分 | sitagliptin |
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| 产品号 | EMEA/H/C/000722 |
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| 患者安全信息 | no |
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| 授权状态 | Authorised |
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| ATC编码 | A10BH01 |
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| 是否额外监管 | no |
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| 是否仿制药 | 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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| 批准上市日期 | 2007/03/20 |
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| 上市许可持有人/公司名称 | Merck Sharp and Dohme B.V |
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| 人用药物治疗分组 | Drugs used in diabetes |
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| 决定日期 | 2023/09/14 |
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| 修订号 | 32 |
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| 适应症 | For adult patients with type-2 diabetes mellitus, Januvia is indicated 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 diet and exercise plus metformin alone do not provide adequate glycaemic control;a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance;a peroxisome-proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;a PPARγ agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control;as triple oral therapy in combination with:a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control. |
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| 首次发布日期 | 2018/05/16 |
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| 修订日期 | 2023/09/18 |
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| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/januvia-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/januvia |
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