| 商品名称 | Imatinib Koanaa |
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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;Gastrointestinal Stromal Tumors |
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| 通用名/非专利名称 | imatinib |
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| 活性成分 | imatinib mesilate |
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| 产品号 | EMEA/H/C/005595 |
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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| 许可状态 | Withdrawn |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 | Nei |
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| 是否仿制药或hybrid药物 | Já |
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| 是否生物类似药 | Nei |
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| 是否附条件批准 | Nei |
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| 是否特殊情形 | Nei |
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| 是否加速审评 | Nei |
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| 是否罕用药 | Nei |
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| 上市许可日期 | 2021/09/22 |
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| 上市许可开发者/申请人/持有人 | Koanaa Healthcare GmbH |
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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 | 2021/07/22 |
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| 欧盟委员会决定日期 | 2021/09/22 |
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| 修订号 | |
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| 治疗适应症 | Imatinib Koanaa is indicated for the treatment of adult and 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. adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric 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 effect of Imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib Koanaa is indicated for the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. 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. 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 GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, 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 | 2021/10/01 |
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| 最后更新日期 | 2023/10/19 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/imatinib-koanaa-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-koanaa |
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