法规知识库 · EMA 集中审评
Xeljanz
tofacitinib · EMEA/H/C/004214 · 已授权
获批上市许可
2017-03-22
欧委会决定日
2026-07-23
持有人 / 申请人
Pfizer Europe MA EEIG
终止日期字段
无
从产品到官方文件
文件记录
24
官方索引 24
EPAR / 审评
21
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AF01
治疗领域：Arthritis, Rheumatoid
药理分类：Immunosuppressants
修订号：38 · 最新影响 PI 的程序：VR/0000337490
适应症（原文）：Rheumatoid arthritisTofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) (see section 5.1). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5). Psoriatic arthritisTofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy (see section 5.1). Ulcerative colitisTofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1). Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs). Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Ankylosing spondylitisTofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional 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。
2026-07-23 · 欧委会决定
2017-03-22 · 获批上市许可
2017-01-26 · 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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Xeljanz-VR-0000339481 : EPAR - Assessment Report - Variation
variation-report · 2026-08-19 · EMADOC-1700519818-3052509
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Xeljanz : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-19
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Xeljanz-PAM-0000291064 : EPAR - Assessment report
variation-report · 2026-07-16 · EMADOC-1700519818-3277680
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Xeljanz : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-10-20
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Xeljanz-H-C-004214-P46-029 : EPAR - Assessment Report
variation-report · 2025-02-24 · EMA/65469/2025
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Xeljanz : EPAR - Risk management plan
rmp · 2025-01-20
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Xeljanz : EPAR - Scientific conclusions for Article 20 referral (Annex IV)
scientific-conclusion · 2023-06-12
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Xeljanz : EPAR - Scientific conclusions for Article 20 referral - Divergent positions of CHMP
scientific-conclusion · 2023-06-12
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Xeljanz-H-A20-1517-C-004214-0048 : EPAR - Assessment Report
variation-report · 2023-06-12 · EMA/586384/2022
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Xeljanz : EPAR - Medicine overview
overview · 2023-06-12 · EMA/351521/2022
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Xeljanz-H-C-PSUSA-00010588-202111 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-09-28 · EMA/780791/2022
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Xeljanz-H-C-004214-II-0039 : EPAR - Assessment Report - Variation
variation-report · 2022-07-08 · EMA/CHMP/623552/2022
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Xeljanz-H-C-004214-II-0035 : EPAR - Assessment Report - Variation
variation-report · 2021-12-14 · EMA/CHMP/743175/2021
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Xeljanz-H-C-4214-X-0024-G: EPAR - Assessment Report - Variation
variation-report · 2021-09-14 · EMA/CHMP/389275/2021
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Xeljanz-H-C-4214-P46-012 : EPAR - Assessment Report
variation-report · 2020-04-20 · EMA/113484/2020
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Xeljanz-H-A-20-1485 : EPAR - Scientific conclusions (PASS) - Article-20
scientific-conclusion · 2020-03-06
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Xeljanz-H-A-20-1485 : EPAR - Scientific conclusions - Article-20
scientific-conclusion · 2019-08-21
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Xeljanz-H-A-20-1485-C-4214-0017: Assessment report on provisional measures - Article 20
variation-report · 2019-07-05 · EMA/309456/2019
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Xeljanz-H-C-4214-X-0005 : EPAR - Assessment Report - Variation
variation-report · 2018-08-20 · EMA/414633/2018
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Xeljanz-H-C-4214-II-0006: EPAR - Assessment Report - Variation
variation-report · 2018-08-16 · EMA/CHMP/197115/2018
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Xeljanz : EPAR - Public assessment report
assessment-report · 2017-03-31 · EMA/CHMP/853224/2016
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。