| 商品名称 | Imatinib Teva B.V. |
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| 适用类别 | Human |
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| 治疗领域 | Dermatofibrosarcoma;Gastrointestinal Stromal Tumors;Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
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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/004748 |
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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| 许可状态 | Withdrawn |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 | L01XE01 |
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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 | 2017/11/15 |
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| 上市许可开发者/申请人/持有人 | Teva B.V. |
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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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| 欧盟委员会决定日期 | 2018/05/08 |
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| 修订号 | |
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| 治疗适应症 | Imatinib Teva B.V. 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 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 Teva B.V. 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. 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 | 2017/11/15 |
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| 最后更新日期 | 2018/10/09 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/imatinib-teva-bv-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-teva-bv |
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