| 商品名称 | Hizentra |
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| 适用类别 | Human |
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| 治疗领域 | Immunologic Deficiency Syndromes |
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| 通用名/非专利名称 | human normal immunoglobulin (SCIg) |
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| 活性成分 | human normal immunoglobulin (SCIg) |
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| 产品号 | EMEA/H/C/002127 |
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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 | J06BA01 |
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| 是否额外监管 | No |
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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 | 2011/04/14 |
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| 上市许可开发者/申请人/持有人 | CSL Behring GmbH |
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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 | 2011/02/17 |
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| 欧盟委员会决定日期 | 2025/09/25 |
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| 修订号 | 28 |
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| 治疗适应症 | Replacement therapy in adults, children and adolescents (0-18 years) in: - Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). - 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 vaccines. Immunomodulatory therapy in adults, children and adolescents (0-18 years): - Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg. |
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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 | 2018/03/05 |
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| 最后更新日期 | 2025/11/24 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/hizentra-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/hizentra |
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