| 商品名称 | Soliris |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hemoglobinuria, Paroxysmal |
| 通用名/非专利名称 | eculizumab |
| 活性成分 | Eculizumab |
| 产品号 | EMEA/H/C/000791 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | L04AA25 |
| 是否额外监管 | no |
| 是否仿制药 | 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 | yes |
| 是否罕用药 | yes |
| 批准上市日期 | 2007/06/20 |
| 上市许可持有人/公司名称 | Alexion Europe SAS |
| 人用药物治疗分组 | Immunosuppressants |
| 决定日期 | 2023/08/14 |
| 修订号 | 36 |
| 适应症 | Soliris is indicated in adults and children for the treatment of:Paroxysmal nocturnal haemoglobinuria (PNH).Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1). Atypical haemolytic uremic syndrome (aHUS).Soliris is indicated in adults for the treatment of:Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1).Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease. |
| 首次发布日期 | 2017/12/14 |
| 修订日期 | 2023/11/30 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/soliris |