法规知识库 · EMA 集中审评
Sovaldi
sofosbuvir · EMEA/H/C/002798 · 已授权
获批上市许可
2014-01-16
欧委会决定日
2023-01-12
持有人 / 申请人
Gilead Sciences Ireland UC
终止日期字段
无
从产品到官方文件
文件记录
16
官方索引 16
EPAR / 审评
14
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J05AX15
治疗领域：Hepatitis C, Chronic
药理分类：Antivirals for systemic use
修订号：29 · 最新影响 PI 的程序：WS/2356
适应症（原文）：Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1. Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
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。
2023-01-12 · 欧委会决定
2014-01-16 · 获批上市许可
2013-11-21 · 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 ↗
Sovaldi : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-09
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Sovaldi : EPAR - Risk-management-plan
rmp · 2026-01-09
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Sovaldi : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-01-09
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Sovaldi-H-C-2798-P46-028 : EPAR - Assessment report
variation-report · 2023-09-27 · EMA/412285/2023
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Sovaldi : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2022-07-06
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Sovaldi-H-C-2798-X-0059-G : EPAR - Assessment Report - Extension
variation-report · 2020-08-14 · EMA/270155/2020
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Sovaldi : EPAR - Medicine overview
overview · 2020-08-14 · EMA/290219/2020
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Sovaldi-H-C-PSUSA-00010134-201812 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-08-30 · EMA/447250/2019
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Sovaldi-H-C-PSUSA-00010134-201712 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-10-16 · EMA/714062/2018
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Sovaldi-H-C-2798-II-0036 : EPAR - Assessment Report - Variation
variation-report · 2017-10-18 · EMA/508676/2017
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Sovaldi-H-C-2798-A20-0029 : EPAR - Scientific Conclusion
scientific-conclusion · 2017-03-13
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Sovaldi-H-C-2798-A20-0029 : EPAR - Assessment Report - Variation
variation-report · 2017-03-13 · EMA/103226/2017
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Sovaldi-H-C-PSUSA-00010134-201512 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-09-23 · EMA/630308/2016
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Sovaldi : EPAR - Public assessment report
assessment-report · 2014-02-05 · EMA/CHMP/688774/2013
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。