| 商品名称 | Emtriva |
|---|---|
| 适用类别 | Human |
| 治疗领域 | HIV Infections |
| 通用名/非专利名称 | emtricitabine |
| 活性成分 | emtricitabine |
| 产品号 | EMEA/H/C/000533 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AF09 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | 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 |
| 上市许可日期 | 2003/10/24 |
| 上市许可开发者/申请人/持有人 | Gilead Sciences Ireland UC |
| 人用药物治疗学分组 | Antivirals for systemic use |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2023/04/18 |
| 修订号 | 33 |
| 治疗适应症 | Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents. This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens. When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/07/24 |
| 最后更新日期 | 2023/04/18 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/emtriva-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/emtriva |