| 商品名称 | Nucala |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Asthma |
| 通用名/非专利名称 | mepolizumab |
| 活性成分 | Mepolizumab |
| 产品号 | EMEA/H/C/003860 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | R03DX09 |
| 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 | 2015/12/01 |
| 上市许可开发者/申请人/持有人 | GlaxoSmithKline Trading Services Limited |
| 人用药物治疗学分组 | Drugs for obstructive airway diseases |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2015/09/23 |
| 欧盟委员会决定日期 | 2025/11/20 |
| 修订号 | 24 |
| 治疗适应症 | Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older . Chronic rhinosinusitis with nasal polyps (CRSwNP)Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. Eosinophilic granulomatosis with polyangiitis (EGPA)Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Hypereosinophilic syndrome (HES)Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/06/01 |
| 最后更新日期 | 2025/12/04 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/nucala |