| 商品名称 | Capvaxive |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Pneumococcal Infections |
| 通用名/非专利名称 | pneumococcal polysaccharide conjugate vaccine (21-valent) |
| 活性成分 | pneumococcal polysaccharide serotype 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B de-O-acetylated, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B conjugated to CRM197 carrier protein |
| 产品号 | EMEA/H/C/006267 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J07AL02 |
| 是否额外监管 | Yes |
| 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 | 2025/03/24 |
| 上市许可开发者/申请人/持有人 | Merck Sharp & Dohme B.V. |
| 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 | 2025/01/30 |
| 修订号 | |
| 治疗适应症 | Capvaxive is indicated for 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.The use of Capvaxive should be in accordance with official recommendations. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2025/01/31 |
| 最后更新日期 | 2025/04/14 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/capvaxive-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/capvaxive |