| 商品名称 | Tysabri |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Multiple Sclerosis |
| 通用名/非专利名称 | natalizumab |
| 活性成分 | natalizumab |
| 产品号 | EMEA/H/C/000603 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L04AG03 |
| 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 | 2006/06/27 |
| 上市许可开发者/申请人/持有人 | Biogen Netherlands B.V. |
| 人用药物治疗学分组 | Monoclonal antibodies |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/11/25 |
| 修订号 | 50 |
| 治疗适应症 | Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: Patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/08/02 |
| 最后更新日期 | 2025/11/25 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tysabri-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tysabri |