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
许可状态Authorised
ATC编码L04AG03
是否额外监管Yes
是否仿制药或hybrid药物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
上市许可日期2023/09/22
上市许可开发者/申请人/持有人Sandoz GmbH
人用药物治疗学分组Immunosuppressants
兽用药物治疗学分组
审评意见日期2023/07/20
欧盟委员会决定日期2025/01/20
修订号1
治疗适应症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.
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2025/01/22
产品说明书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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