| 商品名称 | Rebetol |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hepatitis C, Chronic |
| 通用名/非专利名称 | ribavirin |
| 活性成分 | ribavirin |
| 产品号 | EMEA/H/C/000246 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | J05AP01 |
| 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 | 1999/05/06 |
| 上市许可开发者/申请人/持有人 | Merck Sharp and Dohme B.V |
| 人用药物治疗学分组 | Antivirals for systemic use;Antivirals for treatment of HCV infections |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2018/09/20 |
| 欧盟委员会决定日期 | 2022/11/24 |
| 修订号 | 39 |
| 治疗适应症 | Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/02/03 |
| 最后更新日期 | 2023/11/07 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/rebetol-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/rebetol |