| 商品名称 | Vipidia |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Diabetes Mellitus, Type 2 |
| 通用名/非专利名称 | alogliptin benzoate |
| 活性成分 | alogliptin |
| 产品号 | EMEA/H/C/002182 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | A10BH04 |
| 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 | 2013/09/18 |
| 上市许可开发者/申请人/持有人 | Takeda Pharma A/S |
| 人用药物治疗学分组 | Drugs used in diabetes;Dipeptidyl peptidase 4 (DPP-4) inhibitors |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2023/05/25 |
| 修订号 | 10 |
| 治疗适应症 | Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2015/01/15 |
| 最后更新日期 | 2023/07/21 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/vipidia-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/vipidia |