| 商品名称 | Sitagliptin SUN |
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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 fumarate |
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| 活性成分 | sitagliptin fumarate |
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| 产品号 | EMEA/H/C/005741 |
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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 | A10BH01 |
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| 是否额外监管 | No |
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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 | 2021/12/09 |
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| 上市许可开发者/申请人/持有人 | Sun Pharmaceutical Industries Europe B.V. |
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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 | 2021/10/14 |
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| 欧盟委员会决定日期 | 2025/10/22 |
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| 修订号 | 3 |
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| 治疗适应症 | For adult patients with type 2 diabetes mellitus, Sitagliptin SUN 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 (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? 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 PPAR? agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin SUN 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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| 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 | 2021/10/12 |
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| 最后更新日期 | 2025/11/10 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/sitagliptin-sun-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-sun |
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