法规知识库 · EMA 集中审评
Skyrizi
risankizumab · EMEA/H/C/004759 · 已授权
获批上市许可
2019-04-26
欧委会决定日
2026-09-03
持有人 / 申请人
AbbVie Deutschland GmbH & Co. KG
终止日期字段
无
从产品到官方文件
文件记录
18
官方索引 18
EPAR / 审评
16
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AC18
治疗领域：Psoriasis;Arthritis, Psoriatic;Colitis, Ulcerative;Crohn Disease
药理分类：Immunosuppressants
修订号：32 · 最新影响 PI 的程序：VR/0000343404
适应症（原文）：Adult plaque psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Psoriatic Arthritis Skyrizi, alone or in combination with methotrexate (MTX), 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). Crohn’s disease Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. Ulcerative colitis Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic 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。
2026-09-03 · 欧委会决定
2019-04-26 · 获批上市许可
2019-02-28 · 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
- 打开官方文件 ↗
Skyrizi : EPAR - Procedural steps taken and scientific information after the authorisation
procedural-steps-after · 2026-09-11
- 打开官方文件 ↗
Skyrizi : EPAR - Medicine overview
overview · 2026-08-26 · EMADOC-1829012207-54552
- 打开官方文件 ↗
Skyrizi-X-0000296763 : EPAR - Assessment report - Extension
variation-report · 2026-06-25 · EMADOC-1700519818-3146413
- 打开官方文件 ↗
Skyrizi : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2026-06-25 · EMADOC-1700519818-3042604
- 打开官方文件 ↗
Skyrizi : EPAR - Risk management plan
rmp · 2026-06-25
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Skyrizi : EPAR - Procedural steps taken and scientific information after the authorisation (archive)
procedural-steps-after · 2026-01-19
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Skyrizi-H-C-004759-PAM-265652 : EPAR - Assessment report - Variation
variation-report · 2025-08-01 · EMADOC-1700519818-2265245
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Skyrizi-H-C-PSUSA-00010765-202403 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2025-01-20 · EMA/19434/2025
- 打开官方文件 ↗
Skyrizi-H-C-004759-X-0043-G : EPAR - Assessment report
variation-report · 2024-07-29 · EMA/282885/2024
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Skyrizi-H-C-PSUSA-00010765-202203 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2023-01-17 · EMA/15506/2023
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Skyrizi-H-C-004759-X-0020-G : EPAR - Assessment report - Extension
variation-report · 2022-12-08 · EMA/887275/2022
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Skyrizi-H-C-004759-P46-008 : EPAR - Assessment report
variation-report · 2022-03-14 · EMA/95539/2022
- 打开官方文件 ↗
Skyrizi-H-C-004759-P46-007 : EPAR - Assessment report
variation-report · 2022-01-19 · EMA/15168/2022
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Skyrizi-H-C-004759-II-0014 : EPAR - Assessment report - Variation
variation-report · 2022-01-04 · EMA/639007/2021
- 打开官方文件 ↗
Skyrizi-H-C-004759-P46-006 : EPAR - Assessment report
variation-report · 2021-12-01 · EMA/712018/2021
- 打开官方文件 ↗
Skyrizi : EPAR - Public assessment report
assessment-report · 2019-06-26 · EMA/191996/2019
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。