| 商品名称 | Kivexa |
|---|---|
| 适用类别 | Human |
| 治疗领域 | HIV Infections |
| 通用名/非专利名称 | abacavir, lamivudine |
| 活性成分 | abacavir, lamivudine |
| 产品号 | EMEA/H/C/000581 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | J05AR02 |
| 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 | 2004/12/16 |
| 上市许可持有人/公司名称 | ViiV Healthcare BV |
| 人用药物治疗分组 | Antivirals for treatment of HIV infections, combinations, Antivirals for systemic use |
| 决定日期 | 2023/11/15 |
| 修订号 | 37 |
| 适应症 | Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg.Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele. |
| 首次发布日期 | 2018/01/25 |
| 修订日期 | 2023/11/27 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/kivexa-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/kivexa |