| 商品名称 | Cerdelga |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Gaucher Disease |
| 通用名/非专利名称 | eliglustat |
| 活性成分 | Eliglustat (tartrate) |
| 产品号 | EMEA/H/C/003724 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | A16AX10 |
| 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 | Yes |
| 上市许可日期 | 2015/01/19 |
| 上市许可开发者/申请人/持有人 | Sanofi B.V. |
| 人用药物治疗学分组 | Other alimentary tract and metabolism products |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2014/11/20 |
| 欧盟委员会决定日期 | 2025/05/16 |
| 修订号 | 20 |
| 治疗适应症 | AdultsCerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).Paediatric population (from 6 to < 18 years of age) weighing ≥ 15 kgCerdelga is indicated for paediatric patients with GD1 who are 6 years and older with a minimum body weight of 15 kg, who are stable on enzyme replacement therapy (ERT), and who are CYP2D6 PMs, IMs or EMs. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/06/07 |
| 最后更新日期 | 2025/05/16 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/cerdelga-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/cerdelga |