| 商品名称 | Abrysvo |
|---|
| 适用类别 | Human |
|---|
| 治疗领域 | Respiratory Syncytial Virus Infections |
|---|
| 通用名/非专利名称 | Respiratory syncytial virus vaccine (bivalent, recombinant) |
|---|
| 活性成分 | Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein |
|---|
| 产品号 | EMEA/H/C/006027 |
|---|
| 患者安全信息 | no |
|---|
| 授权状态 | Authorised |
|---|
| ATC编码 | J07BX05 |
|---|
| 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 | yes |
|---|
| 是否罕用药 | no |
|---|
| 批准上市日期 | 2023/08/23 |
|---|
| 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 | 2023/07/20 |
|---|
| 修订号 | |
|---|
| 适应症 | Abrysvo is indicated for:Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy. See sections 4.2 and 5.1.Active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV.The use of this vaccine should be in accordance with official recommendations. |
|---|
| 首次发布日期 | 2023/07/17 |
|---|
| 修订日期 | 2023/09/26 |
|---|
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/abrysvo-epar-product-information_en.pdf |
|---|
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/abrysvo |
|---|