| 商品名称 | Sustiva |
|---|---|
| 适用类别 | Human |
| 治疗领域 | HIV Infections |
| 通用名/非专利名称 | efavirenz |
| 活性成分 | efavirenz |
| 产品号 | EMEA/H/C/000249 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | J05AG03 |
| 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 | 1999/05/28 |
| 上市许可开发者/申请人/持有人 | Bristol-Myers Squibb Pharma EEIG |
| 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 | 1999/02/24 |
| 欧盟委员会决定日期 | 2023/05/23 |
| 修订号 | 48 |
| 治疗适应症 | Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/12/15 |
| 最后更新日期 | 2024/03/14 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/sustiva-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/sustiva |