| 商品名称 | Arsenic trioxide medac |
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| 适用类别 | Human |
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| 治疗领域 | Leukemia, Promyelocytic, Acute |
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| 通用名/非专利名称 | arsenic trioxide |
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| 活性成分 | arsenic trioxide |
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| 产品号 | EMEA/H/C/005218 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | L01XX27 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | Yes |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2020/09/17 |
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| 上市许可开发者/申请人/持有人 | medac Gesellschaft für klinische Spezialpräparate mbH |
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| 人用药物治疗学分组 | Antineoplastic agents |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2020/07/23 |
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| 欧盟委员会决定日期 | 2022/04/22 |
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| 修订号 | 2 |
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| 治疗适应症 | Arsenic trioxide medac 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 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 pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR?) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2020/10/01 |
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| 最后更新日期 | 2022/04/26 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/arsenic-trioxide-medac-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/arsenic-trioxide-medac |
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