欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Lunsumio
适用类别Human
治疗领域Lymphoma, Follicular
通用名/非专利名称mosunetuzumab
活性成分mosunetuzumab
产品号EMEA/H/C/005680
患者安全信息no
授权状态Authorised
ATC编码L01FX25
是否额外监管yes
是否仿制药no
是否生物类似药no
是否附条件批准yes
是否特殊情形no
是否加速审评no
是否罕用药yes
批准上市日期2022/06/03
上市许可持有人/公司名称Roche Registration GmbH
人用药物治疗分组Antineoplastic agents, Monoclonal antibodies
审评意见发布日期2022/04/22
决定日期2023/10/19
修订号2
适应症Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies. 
首次发布日期2022/04/13
修订日期2023/11/09
产品信息https://www.ema.europa.eu/en/documents/product-information/lunsumio-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/lunsumio
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