| 商品名称 | Agenerase |
|---|---|
| 适用类别 | Human |
| 治疗领域 | HIV Infections |
| 通用名/非专利名称 | amprenavir |
| 活性成分 | amprenavir |
| 产品号 | EMEA/H/C/000264 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | J05AE05 |
| 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 | 2000/10/20 |
| 上市许可开发者/申请人/持有人 | Glaxo Group Ltd. |
| 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 | 2011/04/29 |
| 修订号 | 18 |
| 治疗适应症 | Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years. Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5). The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI nave patients (see section 5.1) |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2011/04/29 |
| 最后更新日期 | 2011/06/21 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/agenerase-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/agenerase |