| 商品名称 | Teriflunomide Viatris (previously Teriflunomide Mylan) |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Multiple Sclerosis, Relapsing-Remitting |
| 通用名/非专利名称 | teriflunomide |
| 活性成分 | teriflunomide |
| 产品号 | EMEA/H/C/005962 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L04AA31 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2022/11/09 |
| 上市许可开发者/申请人/持有人 | Viatris Limited |
| 人用药物治疗学分组 | Immunosuppressants |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2022/09/15 |
| 欧盟委员会决定日期 | 2024/12/19 |
| 修订号 | 5 |
| 治疗适应症 | Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC for important information on the population for which efficacy has been established). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2022/09/14 |
| 最后更新日期 | 2025/01/28 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/teriflunomide-viatris-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/teriflunomide-viatris |