欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Inrebic
适用类别Human
治疗领域Myeloproliferative Disorders; Primary Myelofibrosis
通用名/非专利名称fedratinib
活性成分fedratinib dihydrochloride monohydrate
产品号EMEA/H/C/005026
患者安全信息no
授权状态Authorised
ATC编码L01EJ02
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no
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2021/02/08
上市许可持有人/公司名称Bristol Myers Squibb Pharma EEIG
人用药物治疗分组Antineoplastic agents
审评意见发布日期2020/12/10
决定日期2023/02/23
修订号4
适应症Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
首次发布日期2021/03/03
修订日期2023/03/21
产品信息https://www.ema.europa.eu/en/documents/product-information/inrebic-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/inrebic
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