| 商品名称 | Deqsiga |
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| 适用类别 | Human |
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| 治疗领域 | Immunologic Deficiency Syndromes;Purpura, Thrombocytopenic, Idiopathic;Guillain-Barre Syndrome;Mucocutaneous Lymph Node Syndrome;Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
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| 通用名/非专利名称 | human normal immunoglobulin |
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| 活性成分 | human normal immunoglobulin |
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| 产品号 | EMEA/H/C/006423 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | J06BA02 |
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| 是否额外监管 | Yes |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2025/05/02 |
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| 上市许可开发者/申请人/持有人 | Takeda Manufacturing Austria AG |
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| 人用药物治疗学分组 | Immune sera and immunoglobulins |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2025/02/27 |
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| 欧盟委员会决定日期 | 2025/05/02 |
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| 修订号 | |
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| 治疗适应症 | 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). |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2025/02/28 |
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| 最后更新日期 | 2025/05/16 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/deqsiga-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/deqsiga |
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