| 商品名称 | Nodetrip (previously Xeristar) |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Anxiety Disorders; Depressive Disorder, Major; Diabetic Neuropathies |
| 通用名/非专利名称 | duloxetine |
| 活性成分 | duloxetine |
| 产品号 | EMEA/H/C/000573 |
| 患者安全信息 | no |
| 授权状态 | Withdrawn |
| ATC编码 | N06AX21 |
| 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 | 2004/12/17 |
| 上市许可持有人/公司名称 | Esteve Pharmaceuticals, S.A. |
| 人用药物治疗分组 | Psychoanaleptics, |
| 审评意见发布日期 | 2004/09/16 |
| 决定日期 | 2021/05/12 |
| 修订号 | 32 |
| 适应症 | Treatment of major depressive disorder;Treatment of diabetic peripheral neuropathic pain;Treatment of generalised anxiety disorder;Xeristar is indicated in adults. |
| 首次发布日期 | 2016/12/09 |
| 修订日期 | 2021/06/22 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/xeristar-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/nodetrip-previously-xeristar |