法规知识库 · EMA 集中审评
Rinvoq
upadacitinib · EMEA/H/C/004760 · 已授权
获批上市许可
2019-12-16
欧委会决定日
2026-09-17
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
37
官方索引 37
EPAR / 审评
35
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AA44
治疗领域：Arthritis, Rheumatoid;Arthritis, Psoriatic;Axial Spondyloarthritis;Spondylitis, Ankylosing;Giant Cell Arteritis;Dermatitis, Atopic;Colitis, Ulcerative;Crohn Disease;Alopecia Areata;Vitiligo
药理分类：Immunosuppressants
修订号：37 · 最新影响 PI 的程序：VR/0000340945
适应症（原文）：Rheumatoid arthritis Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Rinvoq may be used as monotherapy or in combination with methotrexate. Psoriatic arthritis Rinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with methotrexate. Polyarticular juvenile idiopathic arthritis Rinvoq is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), in patients 2 years of age and older who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) Rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Giant cell arteritis Rinvoq is indicated for the treatment of giant cell arteritis in adult patients. Atopic dermatitis Rinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Alopecia areata Rinvoq is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Vitiligo Rinvoq is indicated for the treatment of non-segmental vitiligo in adults and adolescents 12 years and older who are candidates for systemic therapy. Ulcerative colitis Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Crohn’s disease Rinvoq is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
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。
2026-09-17 · 欧委会决定
2019-12-16 · 获批上市许可
2019-10-17 · 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 ↗
Rinvoq-PAM-0000363246 : EPAR - Assessment report
variation-report · 2026-11-03 · EMADOC-1700519818-3538334
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Rinvoq : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-13
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Rinvoq-X-0000304823 : EPAR - Assessment report - Variation
variation-report · 2026-09-25 · EMADOC-1700519818-3390189
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Rinvoq : EPAR - Medicine overview
overview · 2026-09-25 · EMADOC-1829012207-63629
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Rinvoq : EPAR - Risk management plan
rmp · 2026-09-25
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Rinvoq-PAM-0000355418 : EPAR - Assessment report
variation-report · 2026-09-08 · EMADOC-1700519818-3433696
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Rinvoq-VR-0000325958 : EPAR - Assessment report - Variation
variation-report · 2026-08-17 · EMADOC-1700519818-3190821
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Rinvoq-VR-0000312506 : EPAR - Assessment report - Variation
variation-report · 2026-08-17 · EMADOC-1700519818-2969402
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Rinvoq-PAM-0000337807 : EPAR - Assessment report
variation-report · 2026-07-15 · EMADOC-1700519818-3325357
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Rinvoq-PSUSA-00010823-202508 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-06-09 · EMADOC-1700519818-2996621
- 打开官方文件 ↗
Rinvoq-PAM-0000336291 : EPAR - Assessment report
variation-report · 2026-06-09 · EMADOC-1700519818-3226293
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Rinvoq-PAM-0000295186 : EPAR - Assessment report
variation-report · 2025-11-28 · EMADOC-1700519818-2672206
- 打开官方文件 ↗
Rinvoq : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-09-24
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Rinvoq-PAM-0000268411 : EPAR - Assessment report
variation-report · 2025-09-03 · EMADOC-1700519818-2349591
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Rinvoq-H-C-PSUSA-00010823-202408 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-06-10 · EMA/197464/2025
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Rinvoq-PAM-0000248980 : EPAR - Assessment report
variation-report · 2025-05-15 · EMADOC-1700519818-2134326
- 打开官方文件 ↗
Rinvoq-PAM-0000253500 : EPAR - Assessment report
variation-report · 2025-05-15 · EMADOC-1700519818-2137829
- 打开官方文件 ↗
Rinvoq-H-C-004760-II-0056 : EPAR - Assessment report - Variation
variation-report · 2025-04-14 · EMA/103192/2025
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Rinvoq-H-C-PSUSA-00010823-202308 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-05-24 · EMA/246084/2024
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Rinvoq-H-C-PSUSA-00010823-202302: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-12-20
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Rinvoq: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-06-15
- 打开官方文件 ↗
Rinvoq-H-A20-1517-C-004760-0017 : EPAR - Assessment report
variation-report · 2023-06-14 · EMA/907059/2022
- 打开官方文件 ↗
Rinvoq-H-C-004760-P46-018 : EPAR - Assessment report
variation-report · 2023-06-02 · EMA/151139/2023
- 打开官方文件 ↗
Rinvoq-H-C-004760-II-0027 : EPAR - Assessment report - Variation
variation-report · 2023-04-24 · EMA/113995/2023
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Rinvoq-H-C-004760-P46-015 : EPAR - Assessment report
variation-report · 2022-09-22 · EMA/602548/2022
- 打开官方文件 ↗
Rinvoq-H-C-004760-II-0016 : EPAR - Assessment report - Variation
variation-report · 2022-08-05 · EMA/659973/2022
- 打开官方文件 ↗
Rinvoq-H-C-004760-X-12-G : EPAR - Assessment report - Extension
variation-report · 2022-08-05 · EMA/575056/2022
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CHMP post-authorisation summary of positive opinion for Rinvoq (II-16)
variation-report · 2022-06-24 · EMA/CHMP/560868/2022
- 打开官方文件 ↗
Rinvoq-H-C-PSUSA-00010823-202108 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-06-08 · EMA/567578/2022
- 打开官方文件 ↗
Rinvoq-H-C-PSUSA-00010823-202102 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-01-10 · EMA/773886/2021
- 打开官方文件 ↗
Rinvoq-H-C-004760-P46-011 : EPAR - Assessment report
variation-report · 2021-11-10 · EMA/527511/2021
- 打开官方文件 ↗
Rinvoq-H-C-004760-X-0006-G : EPAR - Assessment report - Variation
variation-report · 2021-09-08 · EMA/396759/2021
- 打开官方文件 ↗
Rinvoq-H-C-004760-II-0005 : EPAR - Assessment report - Variation
variation-report · 2021-02-03 · EMA/708068/2020
- 打开官方文件 ↗
Rinvoq-H-C-004760-II-0004 : EPAR - Assessment report - Variation
variation-report · 2021-02-03 · EMA/708066/2020
- 打开官方文件 ↗
Rinvoq : EPAR - Public assessment report
assessment-report · 2020-03-05 · EMA/608624/2019 Corr.
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。