| 商品名称 | Sitagliptin / Metformin hydrochloride Mylan |
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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 hydrochloride monohydrate, metformin hydrochloride |
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| 活性成分 | sitagliptin hydrochloride monohydrate, metformin hydrochloride |
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| 产品号 | EMEA/H/C/005678 |
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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 | A10BD07 |
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| 是否额外监管 | no |
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| 是否仿制药 | 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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| 批准上市日期 | 2022/02/16 |
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| 上市许可持有人/公司名称 | Mylan Ireland Limited |
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| 人用药物治疗分组 | Drugs used in diabetes |
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| 审评意见发布日期 | 2021/12/16 |
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| 决定日期 | 2023/05/29 |
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| 修订号 | 2 |
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| 适应症 | For adult patients with type 2 diabetes mellitus:Sitagliptin/Metformin hydrochloride Mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Sitagliptin/Metformin hydrochloride Mylan is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Sitagliptin/Metformin hydrochloride Mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARg agonist.Sitagliptin/Metformin hydrochloride Mylan is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control. |
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| 首次发布日期 | 2021/12/14 |
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| 修订日期 | 2023/05/30 |
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| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/sitagliptin/metformin-hydrochloride-mylan-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-metformin-hydrochloride-mylan |
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