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法规知识库 · EMA 集中审评

Rituzena (previously Tuxella)

rituximab · EMEA/H/C/004724 · 已撤市

生物类似药额外监测

获批上市许可

2017-07-13

欧委会决定日

2019-01-28

持有人 / 申请人

Celltrion Healthcare Hungary Kft.

终止日期字段

2019-04-10

从产品到官方文件

文件记录

5

官方索引 5

EPAR / 审评

3

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L01XC02

治疗领域:Lymphoma, Non-Hodgkin;Microscopic Polyangiitis;Leukemia, Lymphocytic, Chronic, B-Cell;Wegener Granulomatosis

药理分类:Antineoplastic agents

修订号:7 · 最新影响 PI 的程序:IG/1053/G

适应症(原文):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).

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。

  1. 2019-04-10 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  2. 2019-01-28 · 欧委会决定

  3. 2017-07-13 · 获批上市许可

  4. 2017-05-18 · CHMP 意见通过

说明书、EPAR 与其他文件

仅展示 EMA 官方 document_url;本站不下载或镜像 PDF。

EPAR / 审评资料 3产品信息 2其他 0

EPAR / 审评资料

  • Rituzena (previously Tuxella) : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2019-02-18

    打开官方文件 ↗
  • Rituzena : EPAR - Summary for the public

    overview · 2017-09-26 · EMA/327752/2017

    打开官方文件 ↗
  • Rituzena : EPAR - Public assessment report

    assessment-report · 2017-08-15 · EMA/CHMP/421811/2017

    打开官方文件 ↗

产品信息

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。