| 商品名称 | Nobilis Influenza H7N1 |
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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 H7 |
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| 活性成分 | inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99) |
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| 产品号 | EMEA/V/C/000123 |
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| 患者安全信息 | no |
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| 授权状态 | Withdrawn |
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| ATC编码 | |
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| 是否额外监管 | no |
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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 | 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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| 批准上市日期 | 2007/05/14 |
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| 上市许可持有人/公司名称 | Intervet International BV |
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| 兽用药物治疗分组 | Immunologicals for aves |
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| 决定日期 | 2010/07/07 |
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| 修订号 | 2 |
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| 适应症 | For active immunisation of chickens and ducks against avian influenza type A, subtype H7N1.Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals.In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. The duration of immunity in ducks is unknown. |
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| 适用物种 | Chicken; Ducks |
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| 兽用药物ATC编码 | QI01AA23 |
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| 首次发布日期 | 2010/07/07 |
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| 修订日期 | 2010/07/26 |
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| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/nobilis-influenza-h7n1-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-h7n1 |
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