| 商品名称 | Pombiliti |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Glycogen Storage Disease Type II |
| 通用名/非专利名称 | cipaglucosidase alfa |
| 活性成分 | Cipaglucosidase alfa |
| 产品号 | EMEA/H/C/005703 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | A16AB |
| 是否额外监管 | yes |
| 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 | no |
| 是否罕用药 | no |
| 批准上市日期 | 2023/03/20 |
| 上市许可持有人/公司名称 | Amicus Therapeutics Europe Limited |
| 人用药物治疗分组 | Other alimentary tract and metabolism products, |
| 审评意见发布日期 | 2022/12/15 |
| 修订号 | |
| 适应症 | Pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency). |
| 首次发布日期 | 2022/12/09 |
| 修订日期 | 2023/05/30 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/pombiliti-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/pombiliti |