法规知识库 · EMA 集中审评
Tracleer
bosentan (as monohydrate) · EMEA/H/C/000401 · 已授权
获批上市许可
2002-05-14
欧委会决定日
2024-10-23
持有人 / 申请人
未知
终止日期字段
无
从产品到官方文件
文件记录
20
官方索引 20
EPAR / 审评
18
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：C02KX01
治疗领域：Scleroderma, Systemic;Hypertension, Pulmonary
药理分类：Antihypertensives
修订号：45 · 最新影响 PI 的程序：N/0107
适应症（原文）：Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.Efficacy has been shown in: Primary (idiopathic and familial) PAH; PAH secondary to scleroderma without significant interstitial pulmonary disease; PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology. Some improvements have also been shown in patients with PAH WHO functional class II. Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
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。
2024-10-23 · 欧委会决定
2002-05-14 · 获批上市许可
2002-02-21 · 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 ↗
Tracleer : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-10-25
- 打开官方文件 ↗
Tracleer : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2024-05-02
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Tracleer-H-C-000401-P46-087 : EPAR - Assessment Report
variation-report · 2021-10-29 · EMA/3311/2021
- 打开官方文件 ↗
Tracleer : EPAR - Medicine overview
overview · 2019-12-03 · EMA/551408/2018
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Tracleer : EPAR - Risk-management-plan summary
rmp-summary · 2019-08-26
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Tracleer-H-C-PSUSA-00000425-201611 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2017-10-04 · EMA/CHMP/542107/2017
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Tracleer-H-C-PSUSA-00000425-201511 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2016-12-16 · EMA/862750/2016
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Tracleer-H-C-401-P46 : EPAR - Assessment Report
variation-report · 2015-10-05 · EMA/554571/2015
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Tracleer-H-C-PSUSA-00000425-201411 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-09-21 · EMA/CHMP/594929/2015
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Tracleer-H-C-401-P46-0081 : EPAR - Assessment Report
variation-report · 2015-07-15 · EMA/CHMP/473644/2015
- 打开官方文件 ↗
Tracleer-H-C-401-II-0066 : EPAR - Assessment Report - Variation
variation-report · 2015-03-13 · EMA/168487/2015
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Tracleer-H-C-401-X-0039 : EPAR - Assessment Report - Extension
variation-report · 2009-08-05
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Tracleer-H-C-401-II-0037 : EPAR - Assessment Report - Variation
variation-report · 2008-08-29
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Tracleer : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2008-01-23
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Tracleer-H-C-401-II-0029 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-08-01
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Tracleer-H-C-401-II-0027 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-07-19
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Tracleer : EPAR - Scientific Discussion
scientific-discussion · 2005-10-21
- 打开官方文件 ↗
Tracleer : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2005-10-21
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。