欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Ribavirin Teva
适用类别Human
治疗领域Hepatitis C, Chronic
通用名/非专利名称ribavirin
活性成分ribavirin
产品号EMEA/H/C/001018
患者安全信息No
许可状态Withdrawn
ATC编码J05AB04
是否额外监管No
是否仿制药或hybrid药物Yes
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2009/03/31
上市许可开发者/申请人/持有人Teva B.V.
人用药物治疗学分组Antivirals for systemic use
兽用药物治疗学分组
欧盟委员会决定日期2021/06/22
修订号15
治疗适应症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.
适用物种
兽用药物ATC编码
首次发布日期2016/11/14
最后更新日期2021/07/09
产品说明书https://www.ema.europa.eu/en/documents/product-information/ribavirin-teva-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/ribavirin-teva
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