| 商品名称 | Gripovac 3 |
|---|---|
| 适用类别 | Veterinary |
| 治疗领域 | |
| 通用名/非专利名称 | inactivated influenza-A virus |
| 活性成分 | inactivated influenza-A virus |
| 产品号 | EMEA/V/C/000157 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | QI09AA03 |
| 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 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2010/01/14 |
| 上市许可开发者/申请人/持有人 | Merial S.A.S. |
| 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 | 2014/12/04 |
| 修订号 | 1 |
| 治疗适应症 | Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection. Onset of immunity: 7 days after primary vaccination. Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above. Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth. |
| 适用物种 | Pigs |
| 兽用药物ATC编码 | QI09AA03 |
| 首次发布日期 | 2014/12/04 |
| 最后更新日期 | 2018/09/04 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/gripovac-3-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/veterinary/EPAR/gripovac-3 |