法规知识库 · EMA 集中审评
Cosentyx
secukinumab · EMEA/H/C/003729 · 已授权
获批上市许可
2015-01-14
欧委会决定日
2026-10-19
持有人 / 申请人
Novartis Europharm Limited
终止日期字段
无
从产品到官方文件
文件记录
28
官方索引 28
EPAR / 审评
26
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AC10
治疗领域：Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing
药理分类：Immunosuppressants
修订号：44 · 最新影响 PI 的程序：VR/0000326984
适应症（原文）：Plaque psoriasis Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. Hidradenitis suppurativa (HS) Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy. Psoriatic arthritis Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate. Axial spondyloarthritis (axSpA) Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-axSpA) Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (NSAIDs). Juvenile idiopathic arthritis (JIA) Enthesitis-related arthritis (ERA)Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Juvenile psoriatic arthritis (JPsA)Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Polymyalgia rheumatica (PMR) Cosentyx is indicated for the treatment of polymyalgia rheumatica in adults who have had an inadequate response to glucocorticoids or who experience a relapse during glucocorticoid taper.
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。
2026-10-19 · 欧委会决定
2015-01-14 · 获批上市许可
2014-11-20 · 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 ↗
Cosentyx-VR-0000326984 : EPAR - Assessment report - Variation
variation-report · 2026-11-05 · EMADOC-1700519818-2942253
- 打开官方文件 ↗
Cosentyx : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-11-05
- 打开官方文件 ↗
Cosentyx : EPAR - Medicine overview
overview · 2026-11-05 · EMADOC-1829012207-75128
- 打开官方文件 ↗
Cosentyx : EPAR - Risk management plan
rmp · 2026-11-05
- 打开官方文件 ↗
Cosentyx-PAM-0000301644 : EPAR - Assessment report
variation-report · 2025-12-18 · EMADOC-1700519818-2769286
- 打开官方文件 ↗
Cosentyx : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-03-26
- 打开官方文件 ↗
Cosentyx-H-C-PSUSA-00010341-202312 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-11-25 · EMA/443964/2024
- 打开官方文件 ↗
Cosentyx-H-C-3729-P46-016 : EPAR - Assessment report
variation-report · 2024-08-16 · EMA/282777/2024
- 打开官方文件 ↗
Cosentyx-H-C-3729-P46-015 : EPAR - Assessment report
variation-report · 2024-01-11 · EMA/581967/2023
- 打开官方文件 ↗
Cosentyx-H-C-3729-II-0090 : EPAR - Assessment report - Variation
variation-report · 2023-06-02 · EMA/214413/2023
- 打开官方文件 ↗
Cosentyx-H-C-3729-P46-014 : EPAR - Assessment report
variation-report · 2023-03-09 · EMA/34114/2023
- 打开官方文件 ↗
Cosentyx-H-C-3729-P46-013 : EPAR - Assessment report
variation-report · 2023-02-13 · EMA/68979/2023
- 打开官方文件 ↗
Cosentyx-H-C-003729-II-0079 : EPAR - Assessment report - Variation
variation-report · 2022-06-24 · EMA/573021/2022
- 打开官方文件 ↗
Cosentyx-H-C-3729-P46-012 : EPAR - Assessment report
variation-report · 2021-09-06 · EMA/471835/2021
- 打开官方文件 ↗
Cosentyx-H-C-003729-II-0073 : EPAR - Assessment Report - Variation
variation-report · 2021-09-03 · EMA/422077/2021
- 打开官方文件 ↗
Cosentyx : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2021-09-03 · EMA/CHMP/309368/2021
- 打开官方文件 ↗
Cosentyx-H-C-PSUSA-00010341-201912 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
variation-report · 2020-09-25 · EMA/503739/2020
- 打开官方文件 ↗
Cosentyx-H-C-3729-II-0057 : EPAR - Assessment Report - Variation
variation-report · 2020-08-24 · EMA/374601/2020
- 打开官方文件 ↗
Cosentyx-H-C-3729-II-0053-G : EPAR - Assessment Report - Variation
variation-report · 2020-05-07 · EMA/199991/2020
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Cosentyx-H-C-3729-P46-009 : EPAR - Assessment Report
variation-report · 2020-04-08 · EMA/93756/2020
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Cosentyx-H-C-PSUSA-00010341-201812 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-10-02 · EMA/521908/2019
- 打开官方文件 ↗
Cosentyx-H-C-PSUSA-00010341-201712 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-10-01 · EMA/566564/2018
- 打开官方文件 ↗
Cosentyx-H-C-PSUSA-00010341-201606 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-03-29 · EMA/123498/2017
- 打开官方文件 ↗
Cosentyx : EPAR - Public assessment report
assessment-report · 2015-03-02 · EMA/CHMP/389874/2014
- 打开官方文件 ↗
Cosentyx-H-C-3729-II-0002 : EPAR - Assessment Report - Variation
variation-report · 2015-01-07 · EMA/CHMP/665405/2015
- 打开官方文件 ↗
Cosentyx-H-C-3729-II-0001-G : EPAR - Assessment Report - Variation
variation-report · 2015-01-07 · EMA/CHMP/665427/2015
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。