| 商品名称 | Truvada |
|---|---|
| 适用类别 | Human |
| 治疗领域 | HIV Infections |
| 通用名/非专利名称 | emtricitabine, tenofovir disoproxil |
| 活性成分 | emtricitabine, tenofovir disoproxil fumarate |
| 产品号 | EMEA/H/C/000594 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | J05AR03 |
| 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 | 2005/02/20 |
| 上市许可持有人/公司名称 | Gilead Sciences Ireland UC |
| 人用药物治疗分组 | Antivirals for systemic use |
| 审评意见发布日期 | 2004/11/18 |
| 决定日期 | 2023/01/12 |
| 修订号 | 46 |
| 适应症 | Treatment of HIV-1 infection:, , , Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults., Truvada is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years., , , Pre-exposure prophylaxis (PrEP):, , , Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk., , |
| 首次发布日期 | 2017/07/19 |
| 修订日期 | 2023/02/02 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/truvada-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/truvada |