| 商品名称 | Tandemact |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Diabetes Mellitus, Type 2 |
| 通用名/非专利名称 | pioglitazone, glimepiride |
| 活性成分 | pioglitazone, glimepiride |
| 产品号 | EMEA/H/C/000680 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | A10BD06 |
| 是否额外监管 | no |
| 是否仿制药 | 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 |
| 批准上市日期 | 2007/01/08 |
| 上市许可持有人/公司名称 | CHEPLAPHARM Arzneimittel GmbH |
| 人用药物治疗分组 | Drugs used in diabetes |
| 决定日期 | 2023/09/07 |
| 修订号 | 22 |
| 适应症 | Tandemact is indicated for the treatment of patients with type-2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride. |
| 首次发布日期 | 2016/11/30 |
| 修订日期 | 2023/09/13 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/tandemact-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tandemact |