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法规知识库 · EMA 集中审评

Bimzelx

bimekizumab · EMEA/H/C/005316 · 已授权

获批上市许可

2021-08-20

欧委会决定日

2026-04-30

持有人 / 申请人

UCB Pharma S.A.

终止日期字段

无

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:L04AC

治疗领域:Psoriasis

药理分类:bimekizumab&nbsp

修订号:14 · 最新影响 PI 的程序:R/0000304244

适应症(原文):Plaque psoriasis Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. Hidradenitis suppurativa (HS)Bimzelx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.

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. 2026-04-30 · 欧委会决定

  2. 2021-08-20 · 获批上市许可

  3. 2021-06-24 · 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 9产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-05-08

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

    procedural-steps-after · 2026-05-08

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  • Bimzelx : EPAR - Risk management plan

    rmp · 2026-03-17

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  • Bimzelx-PAM-0000295862 : EPAR - Assessment report

    variation-report · 2026-01-23 · EMADOC-1700519818-2845417

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  • Bimzelx : EPAR - Medicine overview

    overview · 2024-08-07 · EMA/137147/2024

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  • Bimzelx-H-C-005316-II-0020 : EPAR - Assessment Report - Variation

    variation-report · 2024-04-30 · EMA/145924/2024

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  • Bimzelx-H-C-5316-II-0010 : EPAR - Assessment Report - Variation

    variation-report · 2023-06-15 · EMA/235041/2023

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  • Bimzelx-H-C-5316-II-0011 : EPAR - Assessment Report - Variation

    variation-report · 2023-06-15 · EMA/235043/2023

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  • Bimzelx : EPAR - Public assessment report

    assessment-report · 2021-08-24 · EMA/393532/2021

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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。