| 商品名称 | 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 | emtricitabine;tenofovir disoproxil |
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| 活性成分 | emtricitabine;tenofovir disoproxil maleate |
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| 产品号 | EMEA/H/C/004050 |
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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 | J05AR03 |
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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 | 2016/12/16 |
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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 | 2016/10/13 |
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| 欧盟委员会决定日期 | 2025/06/27 |
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| 修订号 | 17 |
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| 治疗适应症 | Treatment of HIV-1 infection: Emtricitabine/Tenofovir disoproxil Mylan is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). Emtricitabine/Tenofovir disoproxil Mylan is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1). Pre-exposure prophylaxis (PrEP): Emtricitabine/Tenofovir disoproxil Mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1). |
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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 | 2017/06/02 |
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| 最后更新日期 | 2025/06/30 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/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/emtricitabine-tenofovir-disoproxil-mylan |
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