| 商品名称 | Rekambys |
|---|---|
| 适用类别 | Human |
| 治疗领域 | HIV Infections |
| 通用名/非专利名称 | rilpivirine |
| 活性成分 | rilpivirine |
| 产品号 | EMEA/H/C/005060 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AG05 |
| 是否额外监管 | Yes |
| 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 | 2020/12/17 |
| 上市许可开发者/申请人/持有人 | Janssen-Cilag International NV |
| 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 | 2020/10/15 |
| 欧盟委员会决定日期 | 2025/08/14 |
| 修订号 | 13 |
| 治疗适应症 | REKAMBYS is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2021/01/04 |
| 最后更新日期 | 2025/11/04 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/rekambys-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/rekambys |