| 商品名称 | Abiraterone Mylan |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Prostatic Neoplasms |
| 通用名/非专利名称 | abiraterone acetate |
| 活性成分 | abiraterone acetate |
| 产品号 | EMEA/H/C/005368 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L02BX03 |
| 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 | 2021/08/20 |
| 上市许可开发者/申请人/持有人 | Mylan Pharmaceuticals Limited |
| 人用药物治疗学分组 | Endocrine therapy;Other hormone antagonists and related agents |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2021/06/24 |
| 欧盟委员会决定日期 | 2024/12/12 |
| 修订号 | 6 |
| 治疗适应症 | Abiraterone Mylan is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2021/08/26 |
| 最后更新日期 | 2025/01/06 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/abiraterone-mylan-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-mylan |