| 商品名称 | Baraclude |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hepatitis B, Chronic |
| 通用名/非专利名称 | entecavir |
| 活性成分 | Entecavir |
| 产品号 | EMEA/H/C/000623 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AF10 |
| 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 | 2006/06/26 |
| 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 | |
| 欧盟委员会决定日期 | 2025/12/03 |
| 修订号 | 30 |
| 治疗适应症 | Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis; decompensated liver disease. For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/06/26 |
| 最后更新日期 | 2025/12/03 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/baraclude-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/baraclude |