欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Dasatinib Accordpharma
适用类别Human
治疗领域Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
通用名/非专利名称dasatinib (anhydrous)
活性成分dasatinib
产品号EMEA/H/C/005317
患者安全信息no
授权状态Withdrawn
ATC编码L01EA02
是否额外监管no
是否仿制药yes
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
批准上市日期2022/03/24
上市许可持有人/公司名称Accord Healthcare S.L.U.
人用药物治疗分组Antineoplastic agents
审评意见发布日期2022/01/27
决定日期2022/06/22
修订号1
适应症Dasatinib Accordpharma is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.Dasatinib Accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with chemotherapy.
首次发布日期2022/01/24
修订日期2023/03/30
产品信息https://www.ema.europa.eu/en/documents/product-information/dasatinib-accordpharma-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/dasatinib-accordpharma
©2006-2024 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase