法规知识库 · EMA 集中审评
Trudexa
adalimumab · EMEA/H/C/000482 · 已撤市
获批上市许可
2003-09-01
欧委会决定日
2007-06-29
持有人 / 申请人
Abbott Laboratories Ltd.
终止日期字段
2007-07-09
从产品到官方文件
文件记录
11
官方索引 11
EPAR / 审评
9
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L04AA17
治疗领域:Spondylitis, Ankylosing;Arthritis, Rheumatoid;Arthritis, Psoriatic;Crohn Disease
药理分类:Immunosuppressants
修订号:8 · 最新影响 PI 的程序:II/0037
适应症(原文):Rheumatoid arthritisTrudexa in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Trudexa 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. Psoriatic arthritisTrudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Ankylosing spondylitisTrudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Crohn's diseaseTrudexa is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, Trudexa should be given in combination with cortiocosteroids. Trudexa can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).
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。
2007-07-09 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
2007-06-29 · 欧委会决定
2003-09-01 · 获批上市许可
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
- 打开官方文件 ↗
Trudexa : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2008-02-15
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Trudexa-H-C-482-II-33 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2008-02-15
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Trudexa : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2008-02-15
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Trudexa-H-C-482-II-06 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2008-02-15
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Trudexa-H-C-482-II-21 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2008-02-15
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Trudexa-H-C-482-II-22 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2008-02-15
- 打开官方文件 ↗
Trudexa : EPAR - Scientific Discussion
scientific-discussion · 2008-02-15
- 打开官方文件 ↗
Trudexa-H-C-482-II-26 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2008-02-15
- 打开官方文件 ↗
Trudexa : EPAR - Summary for the public
overview · 2008-02-15
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。