欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Flebogamma DIF (previously Flebogammadif)
适用类别Human
治疗领域Mucocutaneous Lymph Node Syndrome; Guillain-Barre Syndrome; Bone Marrow Transplantation; Purpura, Thrombocytopenic, Idiopathic; Immunologic Deficiency Syndromes
通用名/非专利名称human normal immunoglobulin
活性成分Human normal immunoglobulin
产品号EMEA/H/C/000781
患者安全信息no
授权状态Authorised
ATC编码J06BA02
是否额外监管no
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no
批准上市日期2007/07/23
上市许可持有人/公司名称Instituto Grifols S.A.
人用药物治疗分组Immune sera and immunoglobulins,
决定日期2023/10/30
修订号19
适应症Replacement therapy in adults, children and adolescents (0-18 years) in:, , , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (HSCT);, congenital AIDS with recurrent bacterial infections., , , Immunomodulation in adults, children and adolescents (0-18 years) in:, , , primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, Guillain Barré syndrome;, Kawasaki disease., ,
首次发布日期2017/06/29
修订日期2023/11/06
产品信息https://www.ema.europa.eu/en/documents/product-information/flebogamma-dif-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/flebogamma-dif
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