| 商品名称 | Kevzara |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Arthritis, Rheumatoid |
| 通用名/非专利名称 | sarilumab |
| 活性成分 | sarilumab |
| 产品号 | EMEA/H/C/004254 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L04AC14 |
| 是否额外监管 | Yes |
| 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 | 2017/06/23 |
| 上市许可开发者/申请人/持有人 | Sanofi Winthrop Industrie |
| 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 | 2017/04/21 |
| 欧盟委员会决定日期 | 2025/03/28 |
| 修订号 | 15 |
| 治疗适应症 | Rheumatoid arthritisKevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. Polymyalgia rheumaticaKevzara is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper. Polyarticular juvenile idiopathic arthritis Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/08/24 |
| 最后更新日期 | 2025/03/28 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/kevzara-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/kevzara |