| 商品名称 | Kiovig |
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| 适用类别 | Human |
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| 治疗领域 | Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome |
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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 (IVIg) |
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| 产品号 | EMEA/H/C/000628 |
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| 患者安全信息 | no |
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| 授权状态 | Authorised |
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| ATC编码 | J06BA02 |
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| 是否额外监管 | no |
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| 是否仿制药 | 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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| 批准上市日期 | 2006/01/18 |
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| 上市许可持有人/公司名称 | Takeda Manufacturing Austria AG |
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| 人用药物治疗分组 | Immune sera and immunoglobulins, |
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| 决定日期 | 2022/06/24 |
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| 修订号 | 26 |
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| 适应症 | 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). |
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| 首次发布日期 | 2017/06/07 |
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| 修订日期 | 2022/06/27 |
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| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/kiovig-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/kiovig |
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