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法规知识库 · EMA 集中审评

Jayempi

azathioprine · EMEA/H/C/005055 · 已授权

获批上市许可

2021-06-21

欧委会决定日

2026-04-13

持有人 / 申请人

Lipomed GmbH

终止日期字段

无

从产品到官方文件

文件记录

9

官方索引 9

EPAR / 审评

7

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L04AX01

治疗领域:Graft Rejection

药理分类:Immunosuppressants

修订号:9 · 最新影响 PI 的程序:R/0000296298

适应症(原文):Jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. Azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). Jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. Jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases: severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – DMARDs) auto-immune hepatitis systemic lupus erythematosus dermatomyositis polyarteritis nodosa pemphigus vulgaris and bullous pemphigoid Behçet’s disease refractory auto-immune haemolytic anaemia, caused by warm IgG antibodies chronic refractory idiopathic thrombocytopenic purpura Jayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (IBD) (Crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. It is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3 Jayempi is indicated for the treatment of generalised myasthenia gravis. Depending on the severity of the disease, Jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

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. 2026-04-13 · 欧委会决定

  2. 2021-06-21 · 获批上市许可

  3. 2021-04-22 · 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 7产品信息 2其他 0

EPAR / 审评资料

  • Jayempi-PSUSA-00000275-202412 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2026-04-23 · EMADOC-1700519818-2276504

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

    procedural-steps-after · 2026-04-23

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  • Jayempi-PSUSA-00000275-202412 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2025-09-22 · EMADOC-1700519818-2276504

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  • Jayempi : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-03-19

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  • Jayempi : EPAR - Risk-management-plan summary

    rmp-summary · 2024-02-12

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  • Jayempi : EPAR - Public assessment report

    assessment-report · 2021-06-23 · EMA/303143/2021

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  • Jayempi : EPAR - Medicine overview

    overview · 2021-06-23 · EMA/344065/2021

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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。