法规知识库 · EMA 集中审评
Olumiant
baricitinib · EMEA/H/C/004085 · 已授权
获批上市许可
2017-02-13
欧委会决定日
2026-09-10
持有人 / 申请人
Eli Lilly Nederland B.V.
终止日期字段
无
从产品到官方文件
文件记录
21
官方索引 21
EPAR / 审评
18
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AA37
治疗领域：Arthritis, Rheumatoid
药理分类：Immunosuppressants
修订号：29 · 最新影响 PI 的程序：VR/0000320218
适应症（原文）：Rheumatoid arthritis Baricitinib 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). Olumiant may be used as monotherapy or in combination with methotrexate. Atopic Dermatitis Olumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. Alopecia areata Baricitinib is indicated for the treatment of severe alopecia areata in adult and adolescent patients 12 years of age and older. Juvenile idiopathic arthritis Baricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs: Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), Enthesitis related arthritis, and Juvenile psoriatic arthritis. Baricitinib may be used as monotherapy or in combination with methotrexate.
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。
2026-09-10 · 欧委会决定
2017-02-13 · 获批上市许可
2016-12-14 · 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
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Olumiant : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-13
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Olumiant : EPAR - Risk management plan
rmp · 2026-09-17
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Olumiant-PAM-0000338022 : EPAR - Assessment report for paediatric studies submitted according to Article 46 of the Regulation (EC) No 1901/2006
variation-report · 2026-09-08 · EMADOC-1700519818-3329933
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Olumiant : EPAR - Medicine overview
overview · 2026-05-28 · EMADOC-1829012207-45460
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Olumiant-VR-0000288098 : EPAR - Assessment report - Variation
variation-report · 2026-05-07 · EMADOC-1700519818-3023275
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Olumiant : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-07-25
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Olumiant-H-C-004085-II-0046 : EPAR - Assessment report - Variation
variation-report · 2024-07-05 · EMA/275928/2024
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Olumiant-H-C-004085-II-0037 : EPAR - Assessment report - Variation
variation-report · 2023-10-30 · EMA/436396/2023
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Olumiant-H-C-4085-X-0035-G : EPAR - Assessment report - Variation
variation-report · 2023-09-21 · EMA/365746/2023
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Olumiant-H-C-4085-A20-0032 : EPAR – Scientific conclusions - Article 20
scientific-conclusion · 2023-06-15
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Olumiant-H-C-4085-A20-0032 : EPAR - Assessment Report - Article 20
variation-report · 2023-06-15 · EMA/586384/2022
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Olumiant : EPAR - Scientific conclusions for Article 20 referral - Divergent positions of CHMP
scientific-conclusion · 2023-06-15
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Olumiant-H-C-4085-P46-012.1 : EPAR - Assessment report
variation-report · 2023-02-22 · EMA/CHMP/607/2023
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Olumiant-H-C-4085-II-0029-G : EPAR - Assessment report - Variation
variation-report · 2022-06-29 · EMA/572597/2022
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Olumiant-PSUSA-000010578/202002 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-12-15 · EMA/635532/2020
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Olumiant-H-C-4085-II-0016 : EPAR - Assessment report - Variation
variation-report · 2020-10-27 · EMA/520470/2020
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Olumiant-PSUSA-00010578-201902 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-12-03 · EMA/648109/2019
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Olumiant : EPAR - Public assessment report
assessment-report · 2017-03-16 · EMA/13493/2017
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。