| 商品名称 | Leflunomide medac |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Arthritis, Rheumatoid |
| 通用名/非专利名称 | leflunomide |
| 活性成分 | leflunomide |
| 产品号 | EMEA/H/C/001227 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L04AK01 |
| 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 | 2010/07/27 |
| 上市许可开发者/申请人/持有人 | medac Gesellschaft für klinische Spezialpräparate mbH |
| 人用药物治疗学分组 | Selective immunosuppressants |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/12/19 |
| 修订号 | 25 |
| 治疗适应症 | Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD). Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/01/30 |
| 最后更新日期 | 2025/12/19 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/leflunomide-medac-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/leflunomide-medac |