法规知识库 · EMA 集中审评
Viraferon
interferon alfa-2b · EMEA/H/C/000282 · 已撤市
获批上市许可
2000-03-09
欧委会决定日
2008-04-22
持有人 / 申请人
Schering-Plough Europe
终止日期字段
2008-10-13
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
5
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L03AB05
治疗领域:Hepatitis C, Chronic;Hepatitis B, Chronic
药理分类:Immunostimulants
修订号:11 · 最新影响 PI 的程序:II/0059
适应症(原文):Chronic Hepatitis B: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis. Chronic Hepatitis C:Adult patients:IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4). The best way to use IntronA in this indication is in combination with ribavirin. Chidren and adolescents:IntronA is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA. The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load. The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 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。
2008-10-13 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
2008-04-22 · 欧委会决定
2000-03-09 · 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 ↗
Viraferon : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2008-05-27
- 打开官方文件 ↗
Viraferon : EPAR - Summary for the public
overview · 2008-05-27
- 打开官方文件 ↗
Viraferon : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2008-05-27
- 打开官方文件 ↗
Viraferon : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2008-05-27
- 打开官方文件 ↗
Viraferon : EPAR - Scientific Discussion
scientific-discussion · 2008-05-27
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。