| 商品名称 | Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals |
|---|---|
| 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) (split virion, inactivated, adjuvanted) |
| 活性成分 | split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14) |
| 产品号 | EMEA/H/C/001015 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| 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 | 2008/09/26 |
| 上市许可开发者/申请人/持有人 | GlaxoSmithKline Biologicals S.A. |
| 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 | 2011/10/03 |
| 修订号 | 3 |
| 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 vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1). Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg 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 | 2011/10/03 |
| 最后更新日期 | 2012/03/21 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/prepandemic-influenza-vaccine-h5n1-split-virion-inactivated-adjuvanted-glaxosmithkline-biologicals_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/prepandemic-influenza-vaccine-h5n1-split-virion-inactivated-adjuvanted-glaxosmithkline-biologicals |