欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Accofil
适用类别Human
治疗领域
通用名/非专利名称filgrastim
活性成分filgrastim
产品号EMEA/H/C/003956
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2014/09/17
上市许可开发者/申请人/持有人Accord Healthcare S.L.U.
人用药物治疗学分组Immunostimulants
兽用药物治疗学分组
审评意见日期2014/07/24
欧盟委员会决定日期2025/06/12
修订号19
治疗适应症Accofil is indicated for the 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 for the 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 Accofil are similar in adults and children receiving cytotoxic chemotherapy. Accofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ? 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Accofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
适用物种
兽用药物ATC编码
首次发布日期2018/05/25
最后更新日期2025/11/25
产品说明书https://www.ema.europa.eu/en/documents/product-information/accofil-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/accofil
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