| 商品名称 | Sovaldi |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hepatitis C, Chronic |
| 通用名/非专利名称 | sofosbuvir |
| 活性成分 | sofosbuvir |
| 产品号 | EMEA/H/C/002798 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AX15 |
| 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 | Yes |
| 是否罕用药 | No |
| 上市许可日期 | 2014/01/16 |
| 上市许可开发者/申请人/持有人 | Gilead Sciences Ireland UC |
| 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 | 2013/11/21 |
| 欧盟委员会决定日期 | 2023/01/12 |
| 修订号 | 28 |
| 治疗适应症 | Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1. Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/08/06 |
| 最后更新日期 | 2023/09/27 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/sovaldi-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/sovaldi |