| 商品名称 | Emblaveo |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Gram-Negative Bacterial Infections;Urinary Tract Infections;Healthcare-Associated Pneumonia;Soft Tissue Infections |
| 通用名/非专利名称 | aztreonam;avibactam |
| 活性成分 | avibactam;aztreonam |
| 产品号 | EMEA/H/C/006113 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J01DF51 |
| 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 | 2024/04/22 |
| 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 | Antibacterials for systemic use |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2024/03/21 |
| 欧盟委员会决定日期 | 2025/09/11 |
| 修订号 | 2 |
| 治疗适应症 | Emblaveo is indicated for the treatment of the following infections in adult patients (see sections 4.4 and 5.1):• Complicated intra-abdominal infection (cIAI)• Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) • Complicated urinary tract infection (cUTI), including pyelonephritisEmblaveo is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options (see sections 4.2, 4.4, and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2024/03/22 |
| 最后更新日期 | 2025/09/17 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/emblaveo-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/emblaveo |