| 商品名称 | Hexacima |
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| 适用类别 | Human |
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| 治疗领域 | Hepatitis B;Tetanus;Immunization;Meningitis, Haemophilus;Whooping Cough;Poliomyelitis;Diphtheria |
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| 通用名/非专利名称 | diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) |
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| 活性成分 | hepatitis B surface antigen;Diphtheria toxoid;Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin;poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett);Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein;tetanus toxoid |
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| 产品号 | EMEA/H/C/002702 |
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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 | J07CA09 |
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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 | 2013/04/17 |
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| 拒绝上市许可日期 | 2013/02/22 |
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| 上市许可开发者/申请人/持有人 | Sanofi Winthrop Industrie |
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| 人用药物治疗学分组 | Vaccines;Bacterial and viral vaccines, combined |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2013/02/21 |
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| 欧盟委员会决定日期 | 2025/09/26 |
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| 修订号 | 34 |
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| 治疗适应症 | Hexacima (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of this vaccine should be in accordance with official recommendations. |
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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 | 2018/01/08 |
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| 最后更新日期 | 2025/09/29 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/hexacima-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/hexacima |
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