法规知识库 · EMA 集中审评
Ribavirin Teva
ribavirin · EMEA/H/C/001018 · 已撤市
获批上市许可
2009-03-31
欧委会决定日
2021-06-22
持有人 / 申请人
Teva B.V.
终止日期字段
2021-06-22
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:J05AB04
治疗领域:Hepatitis C, Chronic
药理分类:Antivirals for systemic use
修订号:15 · 最新影响 PI 的程序:IA/0023
适应症(原文):Ribavirin Teva is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e. not alfa-2b). Naïve patients Adult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA. Paediatric patients (children 3 years of age and older and adolescents) Ribavirin Teva is indicated, in a combination regimen with interferon alfa2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis. Previous treatment failure patients Adult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.
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。
2021-06-22 · 欧委会决定
2021-06-22 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
2009-03-31 · 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
- 打开官方文件 ↗
Ribavirin Teva : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-07-09 · EMA/CHMP/318704/2014
- 打开官方文件 ↗
Ribavirin Teva-H-C-1018-II-11 : EPAR - Assessment Report - Variation
variation-report · 2021-07-09 · EMA/CHMP/461705/2013
- 打开官方文件 ↗
Ribavirin Teva-H-C-1018-A20-08 : EPAR - Assessment Report - Article 20
variation-report · 2021-07-09 · EMA/12875/2013
- 打开官方文件 ↗
Ribavirin Teva : EPAR - Summary for the public
overview · 2021-07-09
- 打开官方文件 ↗
Ribavirin Teva : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2021-07-09
- 打开官方文件 ↗
Ribavirin Teva : EPAR - Public assessment report
assessment-report · 2021-07-09
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。