| 商品名称 | Zeffix |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hepatitis B, Chronic |
| 通用名/非专利名称 | lamivudine |
| 活性成分 | lamivudine |
| 产品号 | EMEA/H/C/000242 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AF05 |
| 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 | 1999/07/29 |
| 上市许可开发者/申请人/持有人 | GlaxoSmithKline Trading Services Limited |
| 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 | 1999/04/22 |
| 欧盟委员会决定日期 | 2025/05/26 |
| 修订号 | 31 |
| 治疗适应症 | Zeffix is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate; decompensated liver disease in combination with a second agent without cross-resistance to lamivudine. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/01/25 |
| 最后更新日期 | 2025/06/03 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/zeffix-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/zeffix |