| 商品名称 | Prevenar 13 |
|---|
| 适用类别 | Human |
|---|
| 治疗领域 | Pneumococcal Infections;Immunization |
|---|
| 通用名/非专利名称 | pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) |
|---|
| 活性成分 | Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 3;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6A;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19A;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 23F |
|---|
| 产品号 | EMEA/H/C/001104 |
|---|
| 患者安全信息 | No |
|---|
| 许可状态 | Authorised |
|---|
| 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 | 2009/12/09 |
|---|
| 上市许可开发者/申请人/持有人 | Pfizer Europe MA EEIG |
|---|
| 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 | 2009/09/24 |
|---|
| 欧盟委员会决定日期 | 2025/04/24 |
|---|
| 修订号 | 49 |
|---|
| 治疗适应症 | Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults ?18 years of age and the elderly. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the 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 | 2018/03/19 |
|---|
| 最后更新日期 | 2025/04/24 |
|---|
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/prevenar-13-epar-product-information_en.pdf |
|---|
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/prevenar-13 |
|---|