| 商品名称 | Privigen |
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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 (IVIg) |
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| 活性成分 | human normal immunoglobulin (IVIg) |
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| 产品号 | EMEA/H/C/000831 |
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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 | 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 | 2008/04/24 |
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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 | 2008/02/21 |
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| 欧盟委员会决定日期 | 2025/04/25 |
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| 修订号 | 32 |
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| 治疗适应症 | Replacement therapy in adults, and children and adolescents (0-18 years) in: primary immunodeficiency (PID) 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 with 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; chronic inflammatory demyelinating polyneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP. |
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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 | 2017/11/28 |
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| 最后更新日期 | 2025/05/28 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/privigen-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/privigen |
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