法规知识库 · EMA 集中审评
Ruxience
rituximab · EMEA/H/C/004696 · 已授权
获批上市许可
2020-04-01
欧委会决定日
2026-10-05
持有人 / 申请人
Pfizer Europe MA EEIG
终止日期字段
无
从产品到官方文件
文件记录
10
官方索引 10
EPAR / 审评
8
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L01XC02
治疗领域:Leukemia, Lymphocytic, Chronic, B-Cell;Arthritis, Rheumatoid;Microscopic Polyangiitis;Pemphigus
药理分类:Antineoplastic agents
修订号:14 · 最新影响 PI 的程序:VR/0000372519
适应症(原文):Ruxience is indicated in adults for the following indications: Non?Hodgkin’s lymphoma (NHL) Ruxience is indicated for the treatment of previously untreated patients with stage III?IV follicular lymphoma in combination with chemotherapy. Ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Ruxience monotherapy is indicated for treatment of patients with stage III?IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. Ruxience 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) Ruxience 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 rituximab or patients refractory to previous rituximab plus chemotherapy. Rheumatoid arthritis Ruxience 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. Ruxience 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 Ruxience, 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 Ruxience is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
关键日期时间轴
来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。
2026-10-05 · 欧委会决定
2020-04-01 · 获批上市许可
2020-01-30 · CHMP 意见通过
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Ruxience : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-06
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Ruxience : EPAR - Risk management plan
rmp · 2025-07-14
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Ruxience : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-02-13
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Ruxience-H-C-PSUSA-00002652-202211 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2023-11-29 · EMA/540498/2023
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Ruxience-H-C-PSUSA-00002652-202111 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-discussion-variation · 2022-08-31 · EMA/592634/2022
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Ruxience : EPAR - Medicine overview
overview · 2022-03-21 · EMA/143842/2020
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Ruxience-H-C-PSUSA-2652-202011 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-09-13 · EMA/403185/2021
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Ruxience : EPAR - Public assessment report
assessment-report · 2020-04-07 · EMA/CHMP/155201/2020
数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。