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法规知识库 · EMA 集中审评

Remicade

infliximab · EMEA/H/C/000240 · 已授权

获批上市许可

1999-08-13

欧委会决定日

2025-11-26

持有人 / 申请人

Janssen Cilag International NV

终止日期字段

无

从产品到官方文件

文件记录

22

官方索引 22

EPAR / 审评

19

assessment / overview 等

产品信息

3

PI / presentations

其他

0

RMP / PIP 等

ATC:L04AB02

治疗领域:Spondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Crohn Disease;Arthritis, Psoriatic;Colitis, Ulcerative

药理分类:Immunosuppressants

修订号:70 · 最新影响 PI 的程序:T/0000294601

适应症(原文):Rheumatoid arthritis Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated. Adult Crohn's disease Remicade is indicated for: treatment of moderately to severely active Crohn's disease, in adult 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; treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohn's disease Remicade is indicated for treatment of severe, active Crohn's disease, in children and adolescents aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Remicade has been studied only in combination with conventional immunosuppressive therapy. Ulcerative colitis Remicade is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Remicade is indicated for treatment of severely active ulcerative colitis, in paediatric patients aged six to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Ankylosing spondylitis Remicade is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis Remicade is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Remicade should be administered: in combination with methotrexate; or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Remicade has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Psoriasis Remicade is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultraviolet A (PUVA).

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. 2025-11-26 · 欧委会决定

  2. 1999-08-13 · 获批上市许可

  3. 1999-05-19 · 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 19产品信息 3其他 0

EPAR / 审评资料

  • Remicade : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2026-10-16

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  • Remicade : EPAR - Risk management plan

    rmp · 2026-10-16

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  • Remicade : EPAR - Procedural steps taken and scientific information after authorisation (archived)

    procedural-steps-after · 2024-08-28

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  • Remicade : EPAR - Summary for the public

    overview · 2018-12-12

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  • Remicade-H-C-240-PSUV-0180 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

    scientific-conclusion · 2014-07-22 · EMA/418304/2014

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  • Remicade-H-C-240-II-0150 : EPAR - Assessment Report - Variation

    variation-report · 2012-03-21 · EMA/126772/2012

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  • Remicade-H-C-240-II-0142 : EPAR - Assessment Report - Variation

    variation-report · 2011-05-31

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  • Remicade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

    conditions-member-states · 2008-10-02

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  • Remicade-H-240-II-0107 : EPAR - Assessment Report - Variation

    variation-report · 2008-06-04

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  • Remicade-H-C-240-II-0100 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2008-02-13

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  • Remicade-H-C-240-II-0095 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2007-12-06

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  • Remicade-H-C-240-II-0075 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2007-07-10

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  • Remicade-H-C-240-II-0061 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2006-10-24

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  • Remicade-H-C-240-II-0069 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2006-10-24

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  • Remicade-H-C-240-II-0065 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2006-10-24

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  • Remicade-H-C-240-II-0073 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2006-09-12

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  • Remicade : EPAR - Steps taken after authorisation when a cutoff date has been used

    steps-after-cutoff · 2005-12-07

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  • Remicade : EPAR - Scientific Discussion

    scientific-discussion · 2005-12-07

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  • Remicade : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2005-12-07

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产品信息

  • Remicade : EPAR – Product information - tracked changes

    product-information-tracked-changes · 2025-12-15

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  • Remicade : EPAR - Product Information

    product-information · 2025-12-15

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  • Remicade : EPAR - All Authorised presentations

    all-authorised-presentations · 2009-02-10

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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。