欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Tyruko
适用类别Human
治疗领域Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
通用名/非专利名称natalizumab
活性成分natalizumab
产品号EMEA/H/C/005752
患者安全信息no
授权状态Authorised
ATC编码L04AA23
是否额外监管yes
是否仿制药no
是否生物类似药yes
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2023/09/22
上市许可持有人/公司名称Sandoz GmbH
人用药物治疗分组Immunosuppressants
审评意见发布日期2023/07/20
决定日期2023/10/30
修订号1
适应症Tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups:, , Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1), or, Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.,
首次发布日期2023/07/17
修订日期2023/11/20
产品信息https://www.ema.europa.eu/en/documents/product-information/tyruko-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/tyruko
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