| 商品名称 | Truxima |
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| 适用类别 | Human |
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| 治疗领域 | Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;Wegener Granulomatosis;Leukemia, Lymphocytic, Chronic, B-Cell;Microscopic Polyangiitis |
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| 通用名/非专利名称 | rituximab |
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| 活性成分 | rituximab |
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| 产品号 | EMEA/H/C/004112 |
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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 | L01FA01 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | Yes |
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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 | 2017/02/17 |
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| 上市许可开发者/申请人/持有人 | Celltrion Healthcare Hungary Kft. |
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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 | 2016/12/15 |
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| 欧盟委员会决定日期 | 2025/09/25 |
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| 修订号 | 26 |
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| 治疗适应症 | Truxima is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Truxima is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy. Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Truxima monotherapy is indicated for treatment of patients with stage III IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy. Truxima is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Chronic lymphocytic leukaemia (CLL) Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Truxima or patients refractory to previous Truxima plus chemotherapy. Rheumatoid arthritis Truxima in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease modifying anti rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. Truxima has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function, when given in combination with methotrexate. Granulomatosis with polyangiitis and microscopic polyangiitis Truxima, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). Pemphigus vulgaris Truxima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV). |
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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 | 2018/05/17 |
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| 最后更新日期 | 2025/09/29 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/truxima-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/truxima |
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