| 商品名称 | Xelevia |
|---|---|
| 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/000762 |
| 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 | 2007/03/21 |
| 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 | 2023/11/14 |
| 欧盟委员会决定日期 | 2025/11/24 |
| 修订号 | 42 |
| 治疗适应症 | For adult patients with type-2 diabetes mellitus, Xelevia 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. Xelevia 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. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/08/20 |
| 最后更新日期 | 2025/12/01 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/xelevia-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/xelevia |