法规知识库 · EMA 集中审评
Protopic
tacrolimus · EMEA/H/C/000374 · 已授权
获批上市许可
2002-02-27
欧委会决定日
2025-12-02
持有人 / 申请人
LEO Pharma A/S
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
11
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：D11AH01
治疗领域：Dermatitis, Atopic
药理分类：Other dermatological preparations
修订号：29 · 最新影响 PI 的程序：VR/0000314599
适应症（原文）：Flare treatment Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Children (two years of age and above) Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. Maintenance treatment Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
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。
2025-12-02 · 欧委会决定
2002-02-27 · 获批上市许可
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 ↗
Protopic : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-12-03
- 打开官方文件 ↗
Protopic : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-12-03
- 打开官方文件 ↗
Protopic-H-C-PSUSA-00002840-202303 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2024-02-13 · EMA/65864/2024
- 打开官方文件 ↗
Protopic : EPAR - Risk-management-plan summary
rmp-summary · 2020-09-07
- 打开官方文件 ↗
Protopic-H-C-374-PSUSA-00002840-201503 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-01-22 · EMA/CHMP/765303/2015
- 打开官方文件 ↗
Protopic-H-C-374-P45-38 : EPAR - Assessment Report
variation-report · 2012-10-05 · EMA/526627/2011
- 打开官方文件 ↗
Protopic : EPAR - Summary for the public
overview · 2011-08-16
- 打开官方文件 ↗
Protopic-H-C-374-II-34 : EPAR - Assessment Report - Variation
variation-report · 2009-07-06
- 打开官方文件 ↗
Protopic : EPAR - Scientific Conclusion
scientific-conclusion · 2006-08-29
- 打开官方文件 ↗
Protopic : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-08-29
- 打开官方文件 ↗
Protopic : EPAR - Scientific Discussion
scientific-discussion · 2006-08-29
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。