| 商品名称 | Arava |
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| 适用类别 | Human |
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| 治疗领域 | Arthritis, Rheumatoid;Arthritis, Psoriatic |
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| 通用名/非专利名称 | leflunomide |
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| 活性成分 | leflunomide |
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| 产品号 | EMEA/H/C/000235 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | L04AK01 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 1999/09/02 |
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| 上市许可开发者/申请人/持有人 | Sanofi-aventis Deutschland GmbH |
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| 人用药物治疗学分组 | Immunosuppressants |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 1999/05/20 |
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| 欧盟委员会决定日期 | 2025/09/04 |
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| 修订号 | 43 |
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| 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. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2018/04/09 |
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| 最后更新日期 | 2025/10/17 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/arava-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/arava |
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