法规知识库 · EMA 集中审评
Stelara
ustekinumab · EMEA/H/C/000958 · 已授权
获批上市许可
2009-01-16
欧委会决定日
2026-09-03
持有人 / 申请人
Janssen-Cilag International NV
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：L04AC05
治疗领域：Psoriasis;Arthritis, Psoriatic;Crohn Disease;Colitis, Ulcerative
药理分类：Immunosuppressants
修订号：54 · 最新影响 PI 的程序：VR/0000342457
适应症（原文）：Adult Crohn’s Disease Stelara is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Paediatric Crohn's Disease Stelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Adult ulcerative colitis Stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Paediatric ulcerative colitis Stelara is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic. Plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1). Paediatric plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Stelara, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
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。
2026-09-03 · 欧委会决定
2009-01-16 · 获批上市许可
2008-11-20 · 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 ↗
Stelara : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-16
- 打开官方文件 ↗
Stelara-VR-0000316205 - EPAR - Assessment report - Variation
variation-report · 2026-08-18 · EMADOC-1700519818-3138505
- 打开官方文件 ↗
Stelara : EPAR - Risk management plan
rmp · 2026-08-18
- 打开官方文件 ↗
Stelara : EPAR - Medicine overview
overview · 2026-08-18 · EMADOC-1829012207-45437
- 打开官方文件 ↗
Stelara-VR-0000290099 : EPAR - Assessment report - Variation
variation-report · 2026-04-24 · EMADOC-1700519818-2358864
- 打开官方文件 ↗
Stelara : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-04-24
- 打开官方文件 ↗
Stelara-H-C-000958-II-0108 : EPAR - Assessment report - Variation
variation-report · 2025-04-14 · EMA/121491/2025
- 打开官方文件 ↗
Stelara-H-C-958-P46-055 : EPAR - Assessment Report
variation-report · 2023-01-18 · EMA/12636/2023
- 打开官方文件 ↗
Stelara-H-C-PSUSA-00003085-202112 : Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2022-11-15 · EMA/884594/2022
- 打开官方文件 ↗
Stelara-H-C-PSUSA-00003085-202012 : Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-11-18 · EMA/CHMP/684614/2021
- 打开官方文件 ↗
Stelara-H-C-958-P46-051 : EPAR - Assessment Report
variation-report · 2021-09-16 · EMA/294893/2021
- 打开官方文件 ↗
Stelara-H-C-958-II-0073 : EPAR - Assessment Report - Variation
variation-report · 2020-01-22 · EMA/12150/2020
- 打开官方文件 ↗
Stelara : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2020-01-22 · EMA/22261/2020
- 打开官方文件 ↗
Stelara-H-C-PSUSA-00003085-201812 : Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-10-03 · EMA/523745/2019
- 打开官方文件 ↗
Stelara-H-C-958-II-0071 : EPAR - Assessment Report - Variation
variation-report · 2019-09-12 · EMA/450688/2019
- 打开官方文件 ↗
Stelara-H-C-000958-X-0049-G : EPAR - Assessment Report - Extension
variation-report · 2017-02-08 · EMA/657144/2016
- 打开官方文件 ↗
Stelara-H-C-958-II-0042 : EPAR - Assessment Report - Variation
variation-report · 2015-08-13 · EMA/404738/2015
- 打开官方文件 ↗
Stelara-H-C-958-II-0037 : EPAR - Assessment Report - Variation
variation-report · 2014-03-17 · EMA/CHMP/129351/2014
- 打开官方文件 ↗
Stelara-H-C-958-II-0029 : EPAR - Assessment Report - Variation
variation-report · 2013-09-26 · EMA/CHMP/431551/2013
- 打开官方文件 ↗
Stelara : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2010-04-15
- 打开官方文件 ↗
Stelara : EPAR - Public assessment report
assessment-report · 2009-02-09
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。