| 商品名称 | Cerezyme |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Gaucher Disease |
| 通用名/非专利名称 | imiglucerase |
| 活性成分 | imiglucerase |
| 产品号 | EMEA/H/C/000157 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | A16AB02 |
| 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 | 1997/11/17 |
| 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 | 1997/07/23 |
| 欧盟委员会决定日期 | 2025/10/16 |
| 修订号 | 34 |
| 治疗适应症 | Cerezyme (imiglucerase) is indicated for use as longterm enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant nonneurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions: anaemia after exclusion of other causes, such as iron deficiency Thrombocytopenia Bone disease after exclusion of other causes such as Vitamin D deficiency hepatomegaly or splenomegaly |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/08/10 |
| 最后更新日期 | 2025/12/01 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/cerezyme-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/cerezyme |