欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Infergen
适用类别Human
治疗领域Hepatitis C, Chronic
通用名/非专利名称interferon alfacon-1
活性成分interferon alfacon-1
产品号EMEA/H/C/000186
患者安全信息No
许可状态Withdrawn
ATC编码L03AB09
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1999/02/01
上市许可开发者/申请人/持有人Astellas Pharma Europe B.V.
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2006/05/05
修订号8
治疗适应症Treatment of patients of 18 years and older with chronic hepatitis and serum markers for hepatitis C virus (HCV) infection e.g. those who have elevated serum transaminase levels without decompensated liver disease and who are positive for serum HCV-RNA (see section 4.4). Consideration should be given to current official guidance on the appropriate use of interferons for the treatment of patients with chronic hepatitis C.Interferon alfacon-1 should be given alone mainly in case of intolerance or contraindication to ribavirin.
适用物种
兽用药物ATC编码
首次发布日期2006/05/05
最后更新日期2006/06/01
产品说明书
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/infergen
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