| 商品名称 | Repaglinide Teva |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Diabetes Mellitus, Type 2 |
| 通用名/非专利名称 | repaglinide |
| 活性成分 | repaglinide |
| 产品号 | EMEA/H/C/001067 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | A10BX02 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2009/06/28 |
| 上市许可开发者/申请人/持有人 | Teva Pharma 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 | 2009/04/23 |
| 欧盟委员会决定日期 | 2025/02/11 |
| 修订号 | 10 |
| 治疗适应症 | Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2016/05/25 |
| 最后更新日期 | 2025/02/11 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/repaglinide-teva-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/repaglinide-teva |