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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。

  1. 2023-10-30 · 欧委会决定

  2. 2007-07-23 · 获批上市许可

说明书、EPAR 与其他文件

仅展示 EMA 官方 document_url;本站不下载或镜像 PDF。

EPAR / 审评资料 5产品信息 2其他 0

EPAR / 审评资料

  • 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

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产品信息

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。