欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Avonex
适用类别Human
治疗领域Multiple Sclerosis
通用名/非专利名称interferon beta-1a
活性成分interferon beta-1a
产品号EMEA/H/C/000102
患者安全信息No
许可状态Authorised
ATC编码L03AB07
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1997/03/13
上市许可开发者/申请人/持有人Biogen Netherlands 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2025/10/16
修订号40
治疗适应症Avonex is indicated for the treatment of: patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; Avonex slows the progression of disability and decreases the frequency of relapses; patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite MS. Avonex should be discontinued in patients who develop progressive MS.
适用物种
兽用药物ATC编码
首次发布日期2017/05/21
最后更新日期2025/10/16
产品说明书https://www.ema.europa.eu/en/documents/product-information/avonex-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/avonex
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase