| 商品名称 | Fingolimod Accord |
|---|---|
| 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 | fingolimod hydrochloride |
| 产品号 | EMEA/H/C/005191 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L04AA27 |
| 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 | 2020/06/25 |
| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
| 人用药物治疗学分组 | Immunosuppressants;Selective immunosuppressants |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2020/04/30 |
| 欧盟委员会决定日期 | 2025/05/05 |
| 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 patients 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 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 | 2020/07/03 |
| 最后更新日期 | 2025/05/16 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/fingolimod-accord-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/fingolimod-accord |