| 商品名称 | Imatinib Actavis |
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| 适用类别 | Human |
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| 治疗领域 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Myelodysplastic-Myeloproliferative Diseases;Hypereosinophilic Syndrome;Dermatofibrosarcoma |
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| 通用名/非专利名称 | imatinib |
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| 活性成分 | imatinib |
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| 产品号 | EMEA/H/C/002594 |
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| 患者安全信息 | No |
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| 许可状态 | Withdrawn |
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| ATC编码 | L01EA01 |
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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 | 2013/04/17 |
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| 上市许可开发者/申请人/持有人 | Actavis Group PTC ehf |
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| 人用药物治疗学分组 | Protein kinase inhibitors;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 | 2013/02/21 |
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| 欧盟委员会决定日期 | 2021/12/16 |
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| 修订号 | 13 |
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| 治疗适应症 | Imatinib Actavis is indicated for the treatment of: paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment; paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis; adult patients with Ph+ CML in blast crisis; adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy; adult patients with relapsed or refractory Ph+ ALL as monotherapy; adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements; adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement; the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. The effect of imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib Actavis is indicated for: In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases. |
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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 | 2018/01/08 |
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| 最后更新日期 | 2022/07/05 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/imatinib-actavis-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/imatinib-actavis |
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