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授权状态 | Withdrawn |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 |