| 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, elasomeran, elasomeran / imelasomeran, elasomeran / davesomeran, andusomeran |
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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 | yes |
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| 授权状态 | 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 | 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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| 批准上市日期 | 2021/01/06 |
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| 上市许可持有人/公司名称 | Moderna Biotech Spain, S.L. |
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| 人用药物治疗分组 | Vaccines |
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| 审评意见发布日期 | 2021/01/04 |
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| 决定日期 | 2023/10/20 |
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| 修订号 | 41 |
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| 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.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.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. 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.The use of this vaccine should be in accordance with official recommendations. |
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| 首次发布日期 | 2021/01/20 |
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| 修订日期 | 2023/11/21 |
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| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/spikevax-previously-covid-19-vaccine-moderna-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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