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法规知识库 · EMA 集中审评

Protopy

tacrolimus · EMEA/H/C/000375 · 已撤市

获批上市许可

2002-02-28

欧委会决定日

2007-05-03

持有人 / 申请人

Astellas Pharma GmbH

终止日期字段

2008-08-22

从产品到官方文件

文件记录

8

官方索引 8

EPAR / 审评

6

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:D11AX14

治疗领域:Dermatitis, Atopic

药理分类:Other dermatological preparations

修订号:10 · 最新影响 PI 的程序:II/0028

适应症(原文):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. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. 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 4 or more times per year) who have had an initial response to a maximum of 6 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。

  1. 2008-08-22 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  2. 2007-05-03 · 欧委会决定

  3. 2002-02-28 · 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 6产品信息 2其他 0

EPAR / 审评资料

  • Protopy : EPAR - Scientific Discussion

    scientific-discussion · 2008-10-29

    打开官方文件 ↗
  • Protopy : EPAR - Scientific Conclusion

    scientific-conclusion · 2008-10-29

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  • Protopy : EPAR - Summary for the public

    overview · 2008-10-29

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  • Protopy : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2008-10-29

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  • Protopy : EPAR - Steps taken after authorisation when a cutoff date has been used

    steps-after-cutoff · 2008-10-29

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  • Protopy : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2008-10-29

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产品信息

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。