| 商品名称 | Vaxelis |
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| 适用类别 | Human |
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| 治疗领域 | Meningitis, Haemophilus;Poliomyelitis;Tetanus;Diphtheria;Whooping Cough;Hepatitis B |
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| 通用名/非专利名称 | diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed) |
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| 活性成分 | Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3;hepatitis B surface antigen produced in yeast cells;poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein. |
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| 产品号 | EMEA/H/C/003982 |
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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 | 2016/02/15 |
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| 上市许可开发者/申请人/持有人 | MCM Vaccine B.V. |
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| 人用药物治疗学分组 | Vaccines |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2015/12/17 |
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| 欧盟委员会决定日期 | 2025/09/18 |
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| 修订号 | 17 |
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| 治疗适应症 | Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of Vaxelis 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 | 2018/04/06 |
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| 最后更新日期 | 2025/10/14 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/vaxelis-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/vaxelis |
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