| 商品名称 | Naglazyme |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Mucopolysaccharidosis VI |
| 通用名/非专利名称 | galsulfase |
| 活性成分 | galsulfase |
| 产品号 | EMEA/H/C/000640 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | A16AB |
| 是否额外监管 | no |
| 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 | 2006/01/23 |
| 上市许可持有人/公司名称 | BioMarin International Limited |
| 人用药物治疗分组 | Other alimentary tract and metabolism products, |
| 决定日期 | 2022/04/01 |
| 修订号 | 19 |
| 适应症 | Naglazyme is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine-4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1)., , As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease., , A key issue is to treat young patients aged |
| 首次发布日期 | 2018/07/13 |
| 修订日期 | 2022/07/11 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/naglazyme-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/naglazyme |