欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
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
许可状态Authorised
ATC编码A16AB
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2006/01/23
上市许可开发者/申请人/持有人BioMarin International Limited
人用药物治疗学分组Other alimentary tract and metabolism products
兽用药物治疗学分组
欧盟委员会决定日期2024/12/12
修订号20
治疗适应症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 <5 years suffering from a severe form of the disease, even though patients <5 years were not included in the pivotal phase-3 study.
适用物种
兽用药物ATC编码
首次发布日期2018/07/13
最后更新日期2024/12/16
产品说明书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
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