法规知识库 · EMA 集中审评
Adempas
riociguat · EMEA/H/C/002737 · 已授权
获批上市许可
2014-03-27
欧委会决定日
2026-05-22
持有人 / 申请人
Bayer AG
终止日期字段
无
从产品到官方文件
文件记录
11
官方索引 11
EPAR / 审评
8
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：C02KX05
治疗领域：Hypertension, Pulmonary
药理分类：Antihypertensives for pulmonary arterial hypertension
修订号：18 · 最新影响 PI 的程序：N/0000333716
适应症（原文）：Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with inoperable CTEPH, persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity. Pulmonary arterial hypertension (PAH) AdultsAdempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease. PaediatricsAdempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ? 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists.
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。
2026-05-22 · 欧委会决定
2014-03-27 · 获批上市许可
2014-01-23 · 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
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Adempas : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-05-22
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Adempas : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-08-06
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Adempas-H-C-002737-X-0041 : EPAR - Assessment report - Extension
variation-report · 2025-08-05 · EMA/167451/2025
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Adempas : EPAR - Risk management plan
rmp · 2025-08-05
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Adempas : EPAR - Medicine overview
overview · 2025-08-05 · EMA/174531/2025
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Adempas-H-C-002737-II-0037 : EPAR - Assessment report - Variation
variation-report · 2023-08-01 · EMA/229554/2023
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Adempas-H-C-002737-II-0032-G : EPAR - Assessment report - Variation
variation-report · 2021-11-26 · EMA/621814/2021
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Adempas : EPAR - Public assessment report
assessment-report · 2014-04-10 · EMA/CHMP/734750/2013
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。