| 商品名称 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
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| 适用类别 | Human |
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| 治疗领域 | HIV Infections |
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| 通用名/非专利名称 | efavirenz;emtricitabine;tenofovir disoproxil |
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| 活性成分 | efavirenz;emtricitabine;tenofovir disoproxil maleate |
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| 产品号 | EMEA/H/C/004240 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | J05AR06 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | Yes |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2017/09/05 |
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| 上市许可开发者/申请人/持有人 | Mylan Pharmaceuticals Limited |
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| 人用药物治疗学分组 | Antivirals for systemic use |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2017/06/22 |
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| 欧盟委员会决定日期 | 2025/11/18 |
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| 修订号 | 18 |
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| 治疗适应症 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan prior to initiation of their first antiretroviral treatment regimen. The demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients. No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2018/08/15 |
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| 最后更新日期 | 2025/11/18 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/efavirenz/emtricitabine/tenofovir-disoproxil-mylan-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/efavirenz-emtricitabine-tenofovir-disoproxil-mylan |
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