欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Fuzeon
适用类别Human
治疗领域HIV Infections
通用名/非专利名称enfuvirtide
活性成分enfuvirtide
产品号EMEA/H/C/000514
患者安全信息no
授权状态Authorised
ATC编码J05AX07
是否额外监管no
是否仿制药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
批准上市日期2003/05/27
上市许可持有人/公司名称Roche Registration GmbH
人用药物治疗分组Antivirals for systemic use
决定日期2023/03/15
修订号24
适应症Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.
首次发布日期2018/04/06
修订日期2023/04/04
产品信息https://www.ema.europa.eu/en/documents/product-information/fuzeon-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/fuzeon
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