法规知识库 · EMA 集中审评
Flebogamma DIF (previously Flebogammadif)
human normal immunoglobulin · EMEA/H/C/000781 · 已授权
获批上市许可
2007-07-23
欧委会决定日
2023-10-30
持有人 / 申请人
Instituto Grifols S.A.
终止日期字段
无
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
5
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:J06BA02
治疗领域:Mucocutaneous Lymph Node Syndrome;Guillain-Barre Syndrome;Bone Marrow Transplantation;Purpura, Thrombocytopenic, Idiopathic;Immunologic Deficiency Syndromes
药理分类:Immune sera and immunoglobulins
修订号:19 · 最新影响 PI 的程序:IB/0077/G
适应症(原文):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.
关键日期时间轴
来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。
2023-10-30 · 欧委会决定
2007-07-23 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Flebogamma DIF : EPAR - Risk management plan summary
rmp-summary · 2023-11-06
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Flebogamma DIF : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2023-11-06
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Flebogamma DIF : EPAR - Summary for the public
overview · 2012-09-25 · EMA/472805/2012
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Flebogammadif : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2007-09-13
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Flebogammadif : EPAR - Assessment Report
assessment-report · 2007-09-13
数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。