| 商品名称 | Incivo |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hepatitis C, Chronic |
| 通用名/非专利名称 | telaprevir |
| 活性成分 | telaprevir |
| 产品号 | EMEA/H/C/002313 |
| 患者安全信息 | No |
| 许可状态 | Expired |
| ATC编码 | J05AE |
| 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 | 2011/09/19 |
| 上市许可开发者/申请人/持有人 | Janssen-Cilag International N.V. |
| 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 | 2015/06/25 |
| 修订号 | 19 |
| 治疗适应症 | Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis): who are treatment naïve; who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2015/06/25 |
| 最后更新日期 | 2016/10/06 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/incivo-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/incivo |