法规知识库 · EMA 集中审评
Adcirca (previously Tadalafil Lilly)
tadalafil · EMEA/H/C/001021 · 已授权
获批上市许可
2008-10-01
欧委会决定日
2026-01-27
持有人 / 申请人
Eli Lilly Nederland B.V.
终止日期字段
无
从产品到官方文件
文件记录
15
官方索引 15
EPAR / 审评
12
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：G04BE08
治疗领域：Hypertension, Pulmonary
药理分类：Urologicals
修订号：19 · 最新影响 PI 的程序：VR/0000315293
适应症（原文）：AdultsTreatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. Paediatric populationTreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.
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。
2026-01-27 · 欧委会决定
2008-10-01 · 获批上市许可
2008-07-24 · 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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Adcirca : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-27
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Adcirca : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-01-27
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Adcirca-H-C-PSUSA-00002841-201410 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-09-20 · EMA/424777/2023
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Adcirca : EPAR - Risk management plan summary
rmp-summary · 2023-05-12
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Adcirca-H-C-1021-X-0035-G : EPAR - Assessment Report - Variation
variation-report · 2023-05-12 · EMA/140777/2023
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Adcirca : EPAR - Summary for the public
overview · 2023-05-12 · EMA/13362/2023
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Adcirca-H-C-1021-P46-022 : EPAR - Assessment Report
variation-report · 2022-12-21 · EMA/897943/2022
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Adcirca-H-C-1021-P46-021 : EPAR - Assessment Report
variation-report · 2020-02-21 · EMA/82737/2020
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Adcirca (previously Tadalafil Lilly)-H-C-WS1066 : EPAR - Assessment Report
variation-report · 2017-05-24 · EMA/752183/2016
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Adcirca (previously Tadalafil Lilly)-H-C-1021-P46-0019 : EPAR - Assessment Report
variation-report · 2016-11-24 · EMA/CHMP/791379/2016
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Adcirca-H-C-1021-II-0001 : EPAR - Assessment Report - Variation
variation-report · 2010-01-22 · EMA/731375/2009
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Adcirca (previously Tadalafil Lilly) : EPAR - Public assessment report
assessment-report · 2008-10-16
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。