| 商品名称 | Apexxnar |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Pneumococcal Infections |
| 通用名/非专利名称 | pneumococcal polysaccharide conjugate vaccine (20-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 |
| 产品号 | EMEA/H/C/005451 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | J07AL02 |
| 是否额外监管 | yes |
| 是否仿制药 | 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 |
| 批准上市日期 | 2022/02/14 |
| 上市许可持有人/公司名称 | Pfizer Europe MA EEIG |
| 人用药物治疗分组 | Vaccines |
| 审评意见发布日期 | 2021/12/16 |
| 决定日期 | 2023/09/14 |
| 修订号 | 6 |
| 适应症 | Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.Apexxnar should be used in accordance with official recommendations. |
| 首次发布日期 | 2021/12/14 |
| 修订日期 | 2023/11/27 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/prevenar-20-previously-apexxnar-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/apexxnar |