| 商品名称 | Fingolimod Mylan |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Multiple Sclerosis, Relapsing-Remitting |
| 通用名/非专利名称 | fingolimod |
| 活性成分 | |
| 产品号 | EMEA/H/C/005661 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L04AE01 |
| 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 | 2021/08/18 |
| 上市许可开发者/申请人/持有人 | Mylan Pharmaceuticals 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 | 2020/06/25 |
| 欧盟委员会决定日期 | 2025/11/06 |
| 修订号 | 9 |
| 治疗适应症 | Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (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 | 2021/08/31 |
| 最后更新日期 | 2025/11/28 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/fingolimod-mylan-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/fingolimod-mylan |