法规知识库 · EMA 集中审评
Otulfi
ustekinumab · EMEA/H/C/006544 · 已授权
获批上市许可
2024-09-25
欧委会决定日
2026-10-09
持有人 / 申请人
Fresenius Kabi Deutschland GmbH
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
5
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC:L04AC05
治疗领域:Crohn Disease;Colitis, Ulcerative
药理分类:Immunosuppressants
修订号:8 · 最新影响 PI 的程序:VR/0000360286
适应症(原文):Plaque psoriasisOtulfi 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). Paediatric plaque psoriasisOtulfi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, and who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA)Otulfi, 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. Adult Crohn’s DiseaseOtulfi 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 DiseaseOtulfi 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. Crohn’s DiseaseOtulfi 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 or have medical contraindications to such therapies. Ulcerative colitis Otulfi 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.
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。
2026-10-09 · 欧委会决定
2024-09-25 · 获批上市许可
2024-07-25 · 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 ↗
Otulfi : EPAR - Procedural steps taken and scientific information after the authorisation
procedural-steps-after · 2026-11-03
- 打开官方文件 ↗
Otulfi : EPAR - Medicine overview
overview · 2026-10-06 · EMADOC-1829012207-69953
- 打开官方文件 ↗
Otulfi : EPAR - Risk management plan
rmp · 2026-09-23
- 打开官方文件 ↗
Otulfi : EPAR - Procedural steps taken and scientific information after the authorisation (archive)
procedural-steps-after · 2025-05-06
- 打开官方文件 ↗
Otulfi : EPAR - Public assessment report
assessment-report · 2024-10-02 · EMA/378457/2024
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。