| 商品名称 | Azacitidine Mylan |
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| 适用类别 | Human |
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| 治疗领域 | Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, Acute |
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| 通用名/非专利名称 | azacitidine |
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| 活性成分 | azacitidine |
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| 产品号 | EMEA/H/C/004984 |
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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 | L01BC07 |
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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 | 2020/03/27 |
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| 上市许可开发者/申请人/持有人 | Mylan Pharmaceuticals Limited |
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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 | 2020/01/30 |
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| 欧盟委员会决定日期 | 2025/12/12 |
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| 修订号 | 11 |
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| 治疗适应症 | Azacitidine Mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29% marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30% blasts and multi lineage dysplasia, according to World Health Organisation (WHO) classification, AML with > 30% marrow blasts according to the WHO classification. |
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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 | 2020/04/06 |
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| 最后更新日期 | 2025/12/12 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/azacitidine-mylan-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/azacitidine-mylan |
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