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法规知识库 · EMA 集中审评

Hulio

adalimumab · EMEA/H/C/004429 · 已授权

生物类似药

获批上市许可

2018-09-17

欧委会决定日

2026-07-28

持有人 / 申请人

Biosimilar Collaborations Ireland Limited

终止日期字段

无

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L04AB04

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

药理分类:Immunosuppressants;Tumor necrosis factor alpha (TNF-α) inhibitors

修订号:21 · 最新影响 PI 的程序:VR/0000357897

适应症(原文):Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Hulio in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hulio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Hulio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Paediatric plaque psoriasis Hulio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Paediatric Crohn's disease Hulio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric Uveitis Hulio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

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. 2026-07-28 · 欧委会决定

  2. 2018-09-17 · 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 5产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-08-27

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  • Hulio : EPAR - Risk management plan

    rmp · 2026-08-27

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

    procedural-steps-after · 2025-04-09

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  • Hulio : EPAR - Medicine overview

    overview · 2018-09-21 · EMA/518630/2018

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  • Hulio : EPAR - Public assessment report

    assessment-report · 2018-09-21 · EMA/541826/2018

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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。