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法规知识库 · EMA 集中审评

Deqsiga

human normal immunoglobulin · EMEA/H/C/006423 · 已授权

额外监测

获批上市许可

2025-05-02

欧委会决定日

2025-05-02

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

5

官方索引 5

EPAR / 审评

3

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:J06BA02

治疗领域:Immunologic Deficiency Syndromes;Purpura, Thrombocytopenic, Idiopathic;Guillain-Barre Syndrome;Mucocutaneous Lymph Node Syndrome;Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

药理分类:Immune sera and immunoglobulins

修订号:— · 最新影响 PI 的程序:—

适应症(原文):Replacement therapy in adults, children and adolescents (0 to 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production. - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of < 4 g/L.*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccinesImmunomodulation in adults, children and adolescents (0 to 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 (in conjunction with acetylsalicylic acid; see section 4.2). - Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). - 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. 2025-05-02 · 欧委会决定

  2. 2025-05-02 · 获批上市许可

  3. 2025-02-27 · 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 3产品信息 2其他 0

EPAR / 审评资料

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。