| 商品名称 | BTVPUR Alsap 8 |
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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 bluetongue virus vaccine |
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| 活性成分 | bluetongue virus serotype 8 antigen |
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| 产品号 | EMEA/V/C/000146 |
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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| 许可状态 | Withdrawn |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 | QI02AA08 |
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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 | 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 | 2009/03/17 |
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| 上市许可开发者/申请人/持有人 | Merial |
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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 Ovidae;Immunologicals for Bovidae |
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| 欧盟委员会决定日期 | 2014/03/13 |
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| 修订号 | 5 |
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| 治疗适应症 | Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.*(below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ml, indicating no infectious virus transmission). Onset of immunity has been demonstrated 3 weeks after the primary vaccination course. The duration of immunity for cattle and sheep is 1 year after the primary vaccination course. The duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep. |
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| 适用物种 | Sheep;Cattle |
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| 兽用药物ATC编码 | QI02AA08 |
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| 首次发布日期 | 2014/03/13 |
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| 最后更新日期 | 2018/05/16 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/btvpur-alsap-8-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/veterinary/EPAR/btvpur-alsap-8 |
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