| 商品名称 | Prevymis |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Cytomegalovirus Infections |
| 通用名/非专利名称 | letermovir |
| 活性成分 | Letermovir |
| 产品号 | EMEA/H/C/004536 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05 |
| 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 | Yes |
| 上市许可日期 | 2018/01/08 |
| 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 | Antivirals for systemic use |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2017/10/12 |
| 欧盟委员会决定日期 | 2025/12/05 |
| 修订号 | 18 |
| 治疗适应症 | Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 5 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Prevymis is indicated for prophylaxis of CMV disease in CMV-seronegative adult and paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor [D+/R-].Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 15 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). Consideration should be given to official guidance on the appropriate use of antiviral agents. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/07/23 |
| 最后更新日期 | 2025/12/12 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/prevymis-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/prevymis |