欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Viraferon
适用类别Human
治疗领域Hepatitis C, Chronic;Hepatitis B, Chronic
通用名/非专利名称interferon alfa-2b
活性成分interferon alfa-2b
产品号EMEA/H/C/000282
患者安全信息No
许可状态Withdrawn
ATC编码L03AB05
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2000/03/09
上市许可开发者/申请人/持有人Schering-Plough Europe
人用药物治疗学分组Immunostimulants
兽用药物治疗学分组
欧盟委员会决定日期2008/04/22
修订号11
治疗适应症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).
适用物种
兽用药物ATC编码
首次发布日期2008/04/22
最后更新日期2008/11/19
产品说明书https://www.ema.europa.eu/en/documents/product-information/viraferon-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/viraferon
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