| 商品名称 | Victrelis |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hepatitis C, Chronic |
| 通用名/非专利名称 | boceprevir |
| 活性成分 | Boceprevir |
| 产品号 | EMEA/H/C/002332 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | J05AE |
| 是否额外监管 | Nei |
| 是否仿制药或hybrid药物 | Nei |
| 是否生物类似药 | Nei |
| 是否附条件批准 | Nei |
| 是否特殊情形 | Nei |
| 是否加速审评 | Nei |
| 是否罕用药 | Nei |
| 上市许可日期 | 2011/07/18 |
| 上市许可开发者/申请人/持有人 | Merck Sharp Dohme Ltd |
| 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 | 2017/06/29 |
| 修订号 | 22 |
| 治疗适应症 | Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/06/29 |
| 最后更新日期 | 2018/07/31 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/victrelis-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/victrelis |