法规知识库 · EMA 集中审评
Kiovig
human normal immunoglobulin (IVIg) · EMEA/H/C/000628 · 已授权
获批上市许可
2006-01-19
欧委会决定日
2022-06-24
持有人 / 申请人
Takeda Manufacturing Austria AG
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: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:26 · 最新影响 PI 的程序:IB/0117
适应症(原文):Replacement therapy in adults, and children and adolescents (0-18 years) in: primary immunodeficiency 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 and 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; multifocal motor neuropathy (MMN).
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。
2022-06-24 · 欧委会决定
2006-01-19 · 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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Kiovig : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2022-06-27
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Kiovig : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2022-06-27
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Kiovig : EPAR - Medicine overview
overview · 2019-04-24
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Kiovig-H-C-628-II-37 : EPAR - Assessment Report - Variation
variation-report · 2011-09-12 · EMEA/H/C/000628/II/0037
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Kiovig : EPAR - Scientific Discussion
scientific-discussion · 2006-03-22
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。