| 商品名称 | Vimkunya |
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| 适用类别 | Human |
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| 治疗领域 | Chikungunya virus |
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| 通用名/非专利名称 | Chikungunya vaccine (recombinant, adsorbed) |
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| 活性成分 | Chikungunya virus (CHIKV) virus-like particle (VLP) proteins (capsid protein (C) and envelope proteins E1 and E2) derived from CHIKV Senegal strain 37997 produced in human embryonic kidney cells by recombinant DNA technology, adsorbed on aluminium hydroxide, hydrated |
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| 产品号 | EMEA/H/C/005470 |
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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 | |
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| 是否额外监管 | Yes |
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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 | 2025/02/28 |
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| 上市许可开发者/申请人/持有人 | Bavarian Nordic A/S |
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| 人用药物治疗学分组 | |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2025/01/30 |
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| 修订号 | |
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| 治疗适应症 | Vimkunya is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. 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 | 2025/03/24 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/vimkunya-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/vimkunya |
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