欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Ruxience
适用类别Human
治疗领域Leukemia, Lymphocytic, Chronic, B-Cell;Arthritis, Rheumatoid;Microscopic Polyangiitis;Pemphigus
通用名/非专利名称rituximab
活性成分rituximab
产品号EMEA/H/C/004696
患者安全信息No
许可状态Authorised
ATC编码L01XC02
是否额外监管Yes
是否仿制药或hybrid药物No
是否生物类似药Yes
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2020/04/01
上市许可开发者/申请人/持有人Pfizer Europe MA EEIG 
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2020/01/30
欧盟委员会决定日期2025/07/11
修订号13
治疗适应症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).
适用物种
兽用药物ATC编码
首次发布日期2020/04/07
最后更新日期2025/07/14
产品说明书https://www.ema.europa.eu/en/documents/product-information/ruxience-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/ruxience
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