| 商品名称 | Poulvac Flufend H5N3 RG |
|---|---|
| 适用类别 | Veterinary |
| 治疗领域 | |
| 通用名/非专利名称 | recombinant inactivated avian influenza virus |
| 活性成分 | recombinant inactivated avian influenza virus |
| 产品号 | EMEA/V/C/000117 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | QI01AA23 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | No |
| 是否生物类似药 | No |
| 是否附条件批准 | No |
| 是否特殊情形 | Yes |
| 是否加速审评 | Yes |
| 是否罕用药 | No |
| 上市许可日期 | 2006/09/01 |
| 上市许可开发者/申请人/持有人 | Pfizer Limited |
| 人用药物治疗学分组 | |
| 兽用药物治疗学分组 | Immunologicals |
| 欧盟委员会决定日期 | 2012/03/30 |
| 修订号 | 8 |
| 治疗适应症 | For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5. Chickens:Reduction of mortality and virus excretion after challenge.Onset of immunity: 3 weeks after the second injection.Duration of immunity in chickens has not been established yet. Ducks: Reduction of clinical signs and virus excretion after challenge.Onset of immunity: 3 weeks after the second injection.Duration of immunity in ducks : 14 weeks after the second injection. |
| 适用物种 | Chicken;Ducks |
| 兽用药物ATC编码 | QI01AA23 |
| 首次发布日期 | 2012/03/30 |
| 最后更新日期 | 2012/05/07 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/poulvac-flufend-h5n3-rg-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/veterinary/EPAR/poulvac-flufend-h5n3-rg |