| 商品名称 | Enzalutamide Viatris |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Prostatic Neoplasms |
| 通用名/非专利名称 | enzalutamide |
| 活性成分 | enzalutamide |
| 产品号 | EMEA/H/C/006299 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L02BB04 |
| 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 | 2024/08/22 |
| 上市许可开发者/申请人/持有人 | Viatris Limited |
| 人用药物治疗学分组 | Endocrine therapy |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2024/06/27 |
| 欧盟委员会决定日期 | 2024/09/26 |
| 修订号 | 1 |
| 治疗适应症 | Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2024/06/28 |
| 最后更新日期 | 2024/10/09 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/enzalutamide-viatris-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/enzalutamide-viatris |