| 商品名称 | Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris |
|---|---|
| 适用类别 | Human |
| 治疗领域 | HIV Infections |
| 通用名/非专利名称 | emtricitabine;rilpivirine;tenofovir alafenamide |
| 活性成分 | emtricitabine;rilpivirine hydrochloride;tenofovir alafenamide fumarate |
| 产品号 | EMEA/H/C/006491 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AR19 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2025/08/19 |
| 上市许可开发者/申请人/持有人 | Viatris Limited |
| 人用药物治疗学分组 | Antivirals for systemic use |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2025/06/19 |
| 修订号 | |
| 治疗适应症 | Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤ 100 000 HIV 1 RNA copies/mL (see sections 4.2, 4.4 and 5.1). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2025/06/20 |
| 最后更新日期 | 2025/09/25 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/emtricitabine-rilpivirine-tenofovir-alafenamide-viatris-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-rilpivirine-tenofovir-alafenamide-viatris |