| 商品名称 | Glivec |
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| 适用类别 | Human |
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| 治疗领域 | Precursor Cell Lymphoblastic Leukemia-Lymphoma;Gastrointestinal Stromal Tumors;Dermatofibrosarcoma;Myelodysplastic-Myeloproliferative Diseases;Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Hypereosinophilic Syndrome |
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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/000406 |
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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 | 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 | Nei |
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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 | 2001/11/07 |
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| 上市许可开发者/申请人/持有人 | Novartis Europharm 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 | 2001/07/26 |
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| 欧盟委员会决定日期 | 2025/10/16 |
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| 修订号 | 51 |
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| 治疗适应症 | Glivec 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-PDGFRa rearrangement. The effect of Glivec on the outcome of bone-marrow transplantation has not been determined. Glivec 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 Glivec 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 Glivec 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 | 2018/06/25 |
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| 最后更新日期 | 2025/11/12 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/glivec |
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