法规知识库 · EMA 集中审评
Deqsiga
human normal immunoglobulin · EMEA/H/C/006423 · 已授权
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。
2025-05-02 · 欧委会决定
2025-05-02 · 获批上市许可
2025-02-27 · CHMP 意见通过
说明书、EPAR 与其他文件
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EPAR / 审评资料
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