| 商品名称 | Nobilis Influenza H5N6 |
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| 适用类别 | Veterinary |
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| 治疗领域 | |
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| 通用名/非专利名称 | adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5 |
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| 活性成分 | inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84) |
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| 产品号 | EMEA/V/C/000125 |
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| 患者安全信息 | No |
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| 许可状态 | Withdrawn |
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| ATC编码 | QI01AA23 |
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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 | Yes |
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| 是否加速审评 | Yes |
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| 是否罕用药 | No |
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| 上市许可日期 | 2008/01/31 |
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| 上市许可开发者/申请人/持有人 | Intervet International BV |
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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 | Immunologicals for aves |
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| 欧盟委员会决定日期 | 2010/07/05 |
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| 修订号 | 1 |
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| 治疗适应症 | For active immunisation of chickens against avian influenza type A, subtype H5.Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. |
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| 适用物种 | Chicken |
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| 兽用药物ATC编码 | QI01AA23 |
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| 首次发布日期 | 2010/07/05 |
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| 最后更新日期 | 2010/07/26 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/nobilis-influenza-h5n6-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/veterinary/EPAR/nobilis-influenza-h5n6 |
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