欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Enrylaze
适用类别Human
治疗领域Precursor Cell Lymphoblastic Leukemia-Lymphoma
通用名/非专利名称crisantaspase
活性成分crisantaspase
产品号EMEA/H/C/005917
患者安全信息No
许可状态Authorised
ATC编码L01XX02
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No
上市许可日期2023/09/15
上市许可开发者/申请人/持有人Jazz Pharmaceuticals Ireland Limited
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2023/07/20
修订号
治疗适应症Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
适用物种
兽用药物ATC编码
首次发布日期2023/07/17
最后更新日期2023/10/05
产品说明书https://www.ema.europa.eu/en/documents/product-information/enrylaze-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/enrylaze
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