欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Filgrastim Hexal
适用类别Human
治疗领域Hematopoietic Stem Cell Transplantation;Cancer
通用名/非专利名称filgrastim
活性成分filgrastim
产品号EMEA/H/C/000918
患者安全信息No
许可状态Authorised
ATC编码L03AA02
是否额外监管No
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2009/02/06
上市许可开发者/申请人/持有人Hexal AG
人用药物治疗学分组Immunostimulants
兽用药物治疗学分组
欧盟委员会决定日期2025/03/20
修订号26
治疗适应症Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Mobilisation of peripheral blood progenitor cells (PBPCs). In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of of ? 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Treatment of persistent neutropenia (ANC ? 0.5 x 109/l), and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
适用物种
兽用药物ATC编码
首次发布日期2018/05/24
最后更新日期2025/07/08
产品说明书https://www.ema.europa.eu/en/documents/product-information/filgrastim-hexal-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-hexal
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