| 商品名称 | Emtricitabine/Tenofovir disoproxil Krka d.d. |
|---|---|
| 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 succinate |
| 产品号 | EMEA/H/C/004686 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AR03 |
| 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 | 2017/04/28 |
| 上市许可开发者/申请人/持有人 | KRKA, d.d., Novo mesto |
| 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 | 2017/02/23 |
| 欧盟委员会决定日期 | 2025/01/31 |
| 修订号 | 13 |
| 治疗适应症 | Emtricitabine/Tenofovir disoproxil Krka d.d. is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka d.d. 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. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/07/25 |
| 最后更新日期 | 2025/02/05 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/emtricitabine/tenofovir-disoproxil-krka-dd-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabine-tenofovir-disoproxil-krka-dd |