| 商品名称 | Ultomiris |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hemoglobinuria, Paroxysmal |
| 通用名/非专利名称 | ravulizumab |
| 活性成分 | ravulizumab |
| 产品号 | EMEA/H/C/004954 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L04AA43 |
| 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 | 2019/07/02 |
| 上市许可开发者/申请人/持有人 | Alexion Europe SAS |
| 人用药物治疗学分组 | Selective immunosuppressants |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2019/04/26 |
| 欧盟委员会决定日期 | 2025/09/11 |
| 修订号 | 19 |
| 治疗适应症 | Paroxysmal nocturnal haemoglobinuria (PNH)Ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with PNH:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity.- in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5.1). Atypical haemolytic uremic syndrome (aHUS)Ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with aHUS who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5.1). Generalized myasthenia gravis (gMG)Ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive. Neuromyelitis Optica Spectrum Disorder (NMOSD)Ultomiris is indicated in the treatment of adult patients with NMOSD who are anti-aquaporin 4 (AQP4) antibody-positive (see section 5.1). Ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity.- in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. Ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2019/07/10 |
| 最后更新日期 | 2025/10/22 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ultomiris-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ultomiris |