| 商品名称 | Tesavel |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Diabetes Mellitus, Type 2 |
| 通用名/非专利名称 | sitagliptin |
| 活性成分 | sitagliptin |
| 产品号 | EMEA/H/C/000910 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | A10BH01 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | No |
| 是否生物类似药 | No |
| 是否附条件批准 | No |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2008/01/10 |
| 上市许可开发者/申请人/持有人 | Merck Sharp & Dohme B.V. |
| 人用药物治疗学分组 | Drugs used in diabetes |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2007/11/15 |
| 欧盟委员会决定日期 | 2025/11/28 |
| 修订号 | 29 |
| 治疗适应症 | For patients with type-2 diabetes mellitus, Tesavel 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 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 agents do not provide adequate glycaemic control; a peroxisome-proliferator-activated-receptor-gamma (PPAR?) agonist and metformin when use of a PPAR? agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/08/08 |
| 最后更新日期 | 2025/12/01 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tesavel-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tesavel |