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法规知识库 · EMA 集中审评

Wezenla

ustekinumab · EMEA/H/C/006132 · 已授权

生物类似药额外监测

获批上市许可

2024-06-20

欧委会决定日

2026-09-11

持有人 / 申请人

Amgen Technology (Ireland) UC

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

6

assessment / overview 等

产品信息

3

PI / presentations

其他

0

RMP / PIP 等

ATC:L04AC05

治疗领域:Psoriasis;Arthritis, Psoriatic;Crohn Disease

药理分类:Immunosuppressants

修订号:10 · 最新影响 PI 的程序:VR/0000357811

适应症(原文):Crohn’s diseaseWezenla is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Pediatric Crohn's diseaseWezenla is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.Plaque psoriasisWezenla is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).Paediatric plaque psoriasisWezenla is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).Psoriatic arthritis (PsA)Wezenla, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).

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. 2026-09-11 · 欧委会决定

  2. 2024-06-20 · 获批上市许可

  3. 2024-04-25 · 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 6产品信息 3其他 0

EPAR / 审评资料

  • Wezenla : EPAR - Risk management plan

    rmp · 2026-09-16

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  • Wezenla : EPAR - Medicine overview

    overview · 2025-09-19

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

    procedural-steps-after · 2025-06-02

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

    procedural-steps-after · 2025-06-02

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  • Wezenla : EPAR - Risk management plan (archive)

    rmp-summary · 2025-04-24

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  • Wezenla : EPAR - Public assessment report

    assessment-report · 2024-07-18 · EMA/228742/2024

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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。