| 商品名称 | Ambirix |
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| 适用类别 | Human |
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| 治疗领域 | Hepatitis B;Hepatitis A;Immunization |
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| 通用名/非专利名称 | hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) |
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| 活性成分 | hepatitis A virus (inactivated);hepatitis B surface antigen |
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| 产品号 | EMEA/H/C/000426 |
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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 | J07BC20 |
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| 是否额外监管 | Nei |
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| 是否仿制药或hybrid药物 | Nei |
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| 是否生物类似药 | Nei |
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| 是否附条件批准 | Nei |
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| 是否特殊情形 | Nei |
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| 是否加速审评 | Nei |
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| 是否罕用药 | Nei |
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| 上市许可日期 | 2002/08/30 |
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| 上市许可开发者/申请人/持有人 | GlaxoSmithKline Biologicals S.A. |
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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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| 欧盟委员会决定日期 | 2024/02/01 |
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| 修订号 | 18 |
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| 治疗适应症 | Ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-A and hepatitis-B infection. Protection against hepatitis-B infections may not be obtained until after the second dose. Therefore: Ambirix should be used only when there is a relatively low risk of hepatitis-B infection during the vaccination course; it is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured. |
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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 | 2017/10/27 |
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| 最后更新日期 | 2024/02/08 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ambirix-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ambirix |
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