欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称IntronA
适用类别Human
治疗领域Carcinoid Tumor;Leukemia, Hairy Cell;Lymphoma, Follicular;Hepatitis B, Chronic;Hepatitis C, Chronic;Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Melanoma;Multiple Myeloma
通用名/非专利名称interferon alfa-2b
活性成分interferon alfa-2b
产品号EMEA/H/C/000281
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Merck Sharp & Dohme 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2021/06/10
修订号34
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 DNA of hepatitis-B virus (HBV-DNA) and hepatitis-B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and / or fibrosis. Chronic hepatitis C Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon. 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 hepatitis-C virus-RNA (HCV-RNA). The best way to use IntronA in this indication is in combination with ribavirin. Children three years of age and older and adolescents IntronA 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, 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 resulted in reduced final adult height in some patients. The decision to treat should be made on a case-by-case basis. Hairy-cell leukaemia Treatment of patients with hairy cell leukaemia. Chronic myelogenous leukaemia Monotherapy Treatment of adult patients with Philadelphia-chromosome- or bcr/abl-translocation-positive chronic myelogenous leukaemia. Clinical experience indicates that a haematological and cytogenetic major / minor response is obtainable in the majority of patients treated. A major cytogenetic response is defined by < 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is ? 34 %, but < 90 % Ph+ cells in the marrow. Combination therapy The combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy. Multiple myeloma As maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy. Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated. Follicular lymphoma Treatment of high-tumour-burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen. High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°C for more than eight days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia. Carcinoid tumour Treatment of carcinoid tumours with lymph node or liver metastases and with 'carcinoid syndrome'. Malignant melanoma As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g. patients with primary or recurrent (clinical or pathological) lymph-node.
适用物种
兽用药物ATC编码
首次发布日期2017/09/28
最后更新日期2022/12/15
产品说明书https://www.ema.europa.eu/en/documents/product-information/introna-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/introna
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