| 商品名称 | Ertapenem SUN |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Bacterial Infections |
| 通用名/非专利名称 | ertapenem |
| 活性成分 | ertapenem sodium |
| 产品号 | EMEA/H/C/005815 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2022/07/15 |
| 上市许可开发者/申请人/持有人 | SUN Pharmaceutical Industries (Europe) B.V. |
| 人用药物治疗学分组 | ertapenem |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2022/05/19 |
| 欧盟委员会决定日期 | 2024/04/02 |
| 修订号 | 2 |
| 治疗适应症 | Treatment Ertapenem SUN is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1): Intra-abdominal infections Community acquired pneumonia Acute gynaecological infections Diabetic foot infections of the skin and soft tissue (see section 4.4) Prevention Ertapenem SUN is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4). 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 | 2022/05/17 |
| 最后更新日期 | 2024/04/03 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ertapenem-sun-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ertapenem-sun |