欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称ViraferonPeg
适用类别Human
治疗领域Hepatitis C, Chronic
通用名/非专利名称peginterferon alfa-2b
活性成分peginterferon alfa-2b
产品号EMEA/H/C/000329
患者安全信息No
许可状态Withdrawn
ATC编码L03AB10
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2000/05/28
上市许可开发者/申请人/持有人Merck Sharp Dohme Ltd 
人用药物治疗学分组Immunostimulants
兽用药物治疗学分组
审评意见日期2000/02/17
欧盟委员会决定日期2018/09/27
修订号36
治疗适应症Adults (tritherapy) ViraferonPeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-C (CHC) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Please refer to the ribavirin and boceprevir summaries of product characteristics (SmPCs) when ViraferonPeg is to be used in combination with these medicines. Adults (bitherapy and monotherapy) ViraferonPeg is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis-C-virus RNA (HCV-RNA), including patients with compensated cirrhosis and / or co-infected with clinically stable HIV. ViraferonPeg in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy. Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin. Please refer to the ribavirin SmPC when ViraferonPeg is to be used in combination with ribavirin. Paediatric population (bitherapy) ViraferonPeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis C, previously untreated, 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 decision to treat should be made on a case-by-case basis. Please refer to the ribavirin SmPC for capsules or oral solution when ViraferonPeg is to be used in combination with ribavirin.
适用物种
兽用药物ATC编码
首次发布日期2017/06/22
最后更新日期2021/01/22
产品说明书https://www.ema.europa.eu/en/documents/product-information/viraferonpeg-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/viraferonpeg
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