欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Aptivus
适用类别Human
治疗领域HIV Infections
通用名/非专利名称tipranavir
活性成分tipranavir
产品号EMEA/H/C/000631
患者安全信息no
授权状态Authorised
ATC编码J05AE09
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2005/10/25
上市许可持有人/公司名称Boehringer Ingelheim International GmbH
人用药物治疗分组Antivirals for systemic use
审评意见发布日期2005/07/27
决定日期2022/07/28
修订号42
适应症Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors.Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.This indication is based on the results of two phase-III studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years.In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, co-administered with low-dose ritonavir.
首次发布日期2017/11/10
修订日期2022/08/23
产品信息https://www.ema.europa.eu/en/documents/product-information/aptivus-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/aptivus
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