法规知识库 · EMA 集中审评
Orencia
abatacept · EMEA/H/C/000701 · 已授权
获批上市许可
2007-05-21
欧委会决定日
2026-03-12
持有人 / 申请人
Bristol-Myers Squibb Pharma EEIG
终止日期字段
无
从产品到官方文件
文件记录
20
官方索引 20
EPAR / 审评
18
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AA24
治疗领域：Arthritis, Psoriatic;Arthritis, Juvenile Rheumatoid;Arthritis, Rheumatoid
药理分类：Immunosuppressants
修订号：43 · 最新影响 PI 的程序：VR/0000287898
适应症（原文）：Rheumatoid arthritis Orencia, in combination with methotrexate, is indicated for: the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate. Psoriatic arthritis Orencia, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required. Polyarticular juvenile idiopathic arthritis Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 2 years of age and older who have had an inadequate response to previous DMARD therapy. Orencia can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate 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。
2026-03-12 · 欧委会决定
2007-05-21 · 获批上市许可
2007-03-22 · 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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Orencia : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-05-11
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Orencia : EPAR - Risk management plan
rmp · 2026-05-11
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Orencia : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-05-11
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Orencia-H-C-000701-P46-072 : EPAR - Assessment Report
variation-report · 2025-05-19 · EMA/165651/2025
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Orencia-H-C-000701-P46-067 : EPAR - Assessment Report
variation-report · 2022-01-19 · EMA/696828/2021
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Orencia-H-C-701-P46-065 : EPAR - Assessment Report
variation-report · 2020-11-13 · EMA/485288/2020
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Orencia-H-C-701-II-0134 : EPAR - Assessment Report - Variation
variation-report · 2020-01-17 · EMA/692959/2019
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Orencia-H-C-701-P46-064 : EPAR - Assessment Report
variation-report · 2019-09-09 · EMA/257651/2019
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Orencia-H-C-701-P46-063 : EPAR - Assessment Report
variation-report · 2019-05-21 · EMA/191269/2019
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Orencia-H-C-000701-X-117-G : EPAR - Assessment report - Extension
variation-report · 2019-04-12 · EMA/126226/2019
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Orencia : EPAR - Medicine overview
overview · 2019-04-12
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Orencia-H-C-701-P46-058 : EPAR - Assessment Report
variation-report · 2019-03-29 · EMA/43840/2019
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Orencia-H-C-701-II-0105 : EPAR - Assessment Report - Variation
variation-report · 2017-08-09 · EMA/455579/2017
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Orencia-H-C-701-II-0097 : EPAR - Assessment Report - Variation
variation-report · 2016-11-08 · EMA/639090/2016
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Orencia-H-C-701-P46-0039 : EPAR - Assessment Report
variation-report · 2012-11-29 · EMA/763437/2012
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Orencia-H-C-701-II-0033 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2010-07-23
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Orencia : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2007-06-05
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Orencia : EPAR - Scientific Discussion
scientific-discussion · 2007-06-05
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。