| 商品名称 | Spikevax (previously COVID-19 Vaccine Moderna) |
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| 适用类别 | Human |
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| 治疗领域 | COVID-19 virus infection |
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| 通用名/非专利名称 | COVID-19 mRNA vaccine |
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| 活性成分 | single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 |
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| 产品号 | EMEA/H/C/005791 |
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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 | J07BN01 |
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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 | 2021/01/06 |
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| 上市许可开发者/申请人/持有人 | Moderna Biotech Spain, S.L. |
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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 | 2021/01/04 |
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| 欧盟委员会决定日期 | 2025/11/24 |
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| 修订号 | 60 |
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| 治疗适应症 | Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax bivalent Original/Omicron BA.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against COVID-19. The use of this vaccine should be in accordance with official recommendations. Spikevax bivalent Original/Omicron BA.4-5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax LP.8.1 is indicated for active immunisation to prevent COVID 19 caused by SARS-CoV-2 in individuals 6 months of age 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 | 2021/01/20 |
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| 最后更新日期 | 2025/11/28 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/spikevax-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax |
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