| 商品名称 | Rituzena (previously Tuxella) |
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| 适用类别 | Human |
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| 治疗领域 | Lymphoma, Non-Hodgkin;Microscopic Polyangiitis;Leukemia, Lymphocytic, Chronic, B-Cell;Wegener Granulomatosis |
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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/004724 |
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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| 许可状态 | Withdrawn |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 | L01XC02 |
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| 是否额外监管 | Yes |
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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 | 2017/07/13 |
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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 | 2017/05/18 |
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| 欧盟委员会决定日期 | 2019/01/28 |
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| 修订号 | 7 |
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| 治疗适应症 | Rituzena is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Rituzena is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy. Rituzena 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. Rituzena 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) Rituzena 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 Rituzenaor patients refractory to previous Rituzena plus chemotherapy. Granulomatosis with polyangiitis and microscopic polyangiitis Rituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). |
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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 | 2018/07/19 |
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| 最后更新日期 | 2019/07/08 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/rituzena-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/rituzena |
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