| 商品名称 | Arsenic trioxide Accord |
|---|---|
| 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/005175 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| 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 | 2019/11/14 |
| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
| 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 | 2019/09/19 |
| 欧盟委员会决定日期 | 2024/12/03 |
| 修订号 | 7 |
| 治疗适应症 | Arsenic trioxide 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 been examined. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2019/11/26 |
| 最后更新日期 | 2024/12/05 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/arsenic-trioxide-accord-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/arsenic-trioxide-accord |