| 商品名称 | Arsenic trioxide Mylan |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Leukemia, Promyelocytic, Acute |
| 通用名/非专利名称 | arsenic trioxide |
| 活性成分 | arsenic trioxide |
| 产品号 | EMEA/H/C/005235 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | L01XX27 |
| 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 | 2020/04/01 |
| 上市许可开发者/申请人/持有人 | Mylan Ireland Limited |
| 人用药物治疗学分组 | Antineoplastic agents |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2020/01/30 |
| 欧盟委员会决定日期 | 2025/01/14 |
| 修订号 | 6 |
| 治疗适应症 | Arsenic trioxide Mylan is indicated for induction of remission, and consolidation in adult patients with:- Newly diagnosed low to intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/?l) in combination with all trans retinoic acid (ATRA)- Relapsed/refractory acute promyelocytic leukaemia (APL) (Previous treatment should have included a retinoid and chemotherapy)characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic acid receptor alpha (PML/RAR alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not beenexamined. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2020/04/17 |
| 最后更新日期 | 2025/05/06 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/arsenic-trioxide-mylan-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/arsenic-trioxide-mylan |