法规知识库 · EMA 集中审评
Rebetol
ribavirin · EMEA/H/C/000246 · 已撤市
获批上市许可
1999-05-06
欧委会决定日
2022-11-24
持有人 / 申请人
Merck Sharp and Dohme B.V
终止日期字段
2023-10-18
从产品到官方文件
文件记录
17
官方索引 17
EPAR / 审评
15
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J05AP01
治疗领域：Hepatitis C, Chronic
药理分类：Antivirals for systemic use;Antivirals for treatment of HCV infections
修订号：39 · 最新影响 PI 的程序：IAIN/0093/G
适应症（原文）：Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.
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。
2023-10-18 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2022-11-24 · 欧委会决定
2018-09-20 · CHMP 意见通过
1999-05-06 · 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
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Rebetol-H-C-PSUSA-00010007-202007 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2023-11-07 · EMA/155557/2021
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Rebetol : EPAR - Risk-management-plan summary
rmp-summary · 2023-11-07
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Rebetol-H-C-246-II-0074: EPAR - Assessment Report - Variation
variation-report · 2023-11-07 · EMA/CHMP/174072/2015
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Rebetol-H-C-PSUSA-10007-201307 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-11-07 · EMA/CHMP/317751/2014
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Rebetol-H-C-246-WS-0216 : EPAR - Assessment Report - Variation
variation-report · 2023-11-07
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Rebetol-H-C-246-II-0048 : EPAR - Assessment Report - Variation
variation-report · 2023-11-07 · EMA/26308/2010
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Rebetol-H-C-246-II-0049 : EPAR - Assessment Report - Variation
variation-report · 2023-11-07 · EMA/6094/2010
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Rebetol : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2023-11-07
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Rebetol : EPAR - Summary for the public
overview · 2023-11-07
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Rebetol-H-C-246-II-0035 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2023-11-07
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Rebetol : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2023-11-07
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Rebetol-H-C-246-X-0016 : EPAR - Scientific Discussion - Extension
scientific-discussion-variation · 2023-11-07
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Rebetol : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2023-11-07
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Rebetol : EPAR - Scientific Discussion
scientific-discussion · 2023-11-07
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Rebetol-H-C-246-II-0034 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-08-02
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。