| 商品名称 | Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Influenza, Human;Immunization;Disease Outbreaks |
| 通用名/非专利名称 | prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) |
| 活性成分 | influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1) |
| 产品号 | EMEA/H/C/002269 |
| 患者安全信息 | No |
| 许可状态 | Expired |
| ATC编码 | J07BB02 |
| 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 | 2010/11/29 |
| 上市许可开发者/申请人/持有人 | Novartis Vaccines and Diagnostics S.r.l. |
| 人用药物治疗学分组 | Vaccines |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2015/07/28 |
| 修订号 | 2 |
| 治疗适应症 | Active immunisation against H5N1 subtype of Influenza A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/Vietnam/1194/2004 (H5N1)-like strain. Prepandemic influenza vaccine (H5N1) Novartis Vaccines and Diagnostic should be used in accordance with official recommendations. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2015/07/28 |
| 最后更新日期 | 2016/03/07 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/prepandemic-influenza-vaccine-h5n1-surface-antigen-inactivated-adjuvanted-novartis-vaccines_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/prepandemic-influenza-vaccine-h5n1-surface-antigen-inactivated-adjuvanted-novartis-vaccines-diagnostics |