| 商品名称 | Leflunomide ratiopharm |
|---|---|
| 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/002035 |
| 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 | 2010/11/28 |
| 上市许可开发者/申请人/持有人 | Ratiopharm GmbH |
| 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 | 2010/09/23 |
| 欧盟委员会决定日期 | 2025/12/18 |
| 修订号 | 20 |
| 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); active psoriatic arthritis. 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 | 2017/12/21 |
| 最后更新日期 | 2025/12/18 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/leflunomide-ratiopharm-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/leflunomide-ratiopharm |