| 商品名称 | Pandemic Influenza Vaccine H5N1 Baxter AG |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Influenza, Human;Immunization;Disease Outbreaks |
| 通用名/非专利名称 | pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) |
| 活性成分 | influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1) |
| 产品号 | EMEA/H/C/001200 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | J07BB01 |
| 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 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2009/10/16 |
| 上市许可开发者/申请人/持有人 | Resilience Biomanufacturing Ireland Limited |
| 人用药物治疗学分组 | Vaccines |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2009/08/23 |
| 欧盟委员会决定日期 | 2023/02/01 |
| 修订号 | 8 |
| 治疗适应症 | Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/03/24 |
| 最后更新日期 | 2023/09/13 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/pandemic-influenza-vaccine-h5n1-baxter-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/pandemic-influenza-vaccine-h5n1-baxter-ag |