| 商品名称 | Prevenar |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Pneumococcal Infections;Immunization |
| 通用名/非专利名称 | pneumococcal saccharide conjugated vaccine, adsorbed |
| 活性成分 | pneumococcal oligosaccharide serotype 18C;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 23F;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 14 |
| 产品号 | EMEA/H/C/000323 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | J07AL02 |
| 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 | 2001/02/02 |
| 上市许可开发者/申请人/持有人 | Pfizer Limited |
| 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 | 2015/06/22 |
| 修订号 | 23 |
| 治疗适应症 | Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age. The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2015/06/22 |
| 最后更新日期 | 2017/11/24 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/prevenar-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/prevenar |