跳到正文

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。

  1. 2022-06-24 · 欧委会决定

  2. 2006-01-19 · 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

  • Kiovig : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2022-06-27

    打开官方文件 ↗
  • Kiovig : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2022-06-27

    打开官方文件 ↗
  • Kiovig : EPAR - Medicine overview

    overview · 2019-04-24

    打开官方文件 ↗
  • Kiovig-H-C-628-II-37 : EPAR - Assessment Report - Variation

    variation-report · 2011-09-12 · EMEA/H/C/000628/II/0037

    打开官方文件 ↗
  • Kiovig : EPAR - Scientific Discussion

    scientific-discussion · 2006-03-22

    打开官方文件 ↗

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。