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法规知识库 · EMA 集中审评

Ribavirin Teva

ribavirin · EMEA/H/C/001018 · 已撤市

仿制药

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。

  1. 2021-06-22 · 欧委会决定

  2. 2021-06-22 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  3. 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 6产品信息 2其他 0

EPAR / 审评资料

  • 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

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  • Ribavirin Teva : EPAR - Summary for the public

    overview · 2021-07-09

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  • Ribavirin Teva : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2021-07-09

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  • Ribavirin Teva : EPAR - Public assessment report

    assessment-report · 2021-07-09

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产品信息

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。