法规知识库 · EMA 集中审评
Privigen
human normal immunoglobulin (IVIg) · EMEA/H/C/000831 · 已授权
获批上市许可
2008-04-24
欧委会决定日
2026-05-26
持有人 / 申请人
CSL Behring GmbH
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
11
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:J06BA02
治疗领域:Purpura, Thrombocytopenic, Idiopathic;Bone Marrow Transplantation;Immunologic Deficiency Syndromes;Guillain-Barre Syndrome;Mucocutaneous Lymph Node Syndrome
药理分类:Immune sera and immunoglobulins
修订号:34 · 最新影响 PI 的程序:VR/0000304719
适应症(原文):Replacement therapy in adults, and children and adolescents (0-18 years) in: primary immunodeficiency (PID) syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who have failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, and 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; chronic inflammatory demyelinating polyneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.
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。
2026-05-26 · 欧委会决定
2008-04-24 · 获批上市许可
2008-02-21 · CHMP 意见通过
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
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Privigen- PAM-0000319183 : EPAR - Assessment Report
variation-report · 2026-07-31 · EMADOC-1700519818-3181751
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Privigen : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-24
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Privigen-VR-0000304719 : EPAR - Assessment report - Variation
variation-report · 2026-06-24 · EMADOC-1700519818-3007695
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Privigen : EPAR - Risk management plan
rmp · 2026-06-24
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Privigen : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-06-24
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Privigen : EPAR - Medicine overview
overview · 2026-06-24 · EMA/612651/2020
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Privigen-H-C-831-P46-0034.1 : EPAR - Assessment Report
variation-report · 2023-06-15 · EMA/226228/2023
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Privigen-H-C-831-P46-034 : EPAR - Assessment Report
variation-report · 2022-06-10 · EMA/578878/2022
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Privigen-H-C-831-P46-032 : EPAR - Assessment Report
variation-report · 2022-03-09 · EMA/CHMP/185004/2019
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Privigen-H-C-831-II-0063 : EPAR - Assessment Report - Variation
variation-report · 2013-05-06 · EMA/CHMP/749630/2012
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Privigen : EPAR - Public assessment report
assessment-report · 2008-05-20
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。