| Product No | EMEA/H/C/005815 |
|---|---|
| Brand Name | Ertapenem SUN |
| Nonproprietary Name | ertapenem |
| API | ertapenem sodium |
| Indications | TreatmentErtapenem 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)PreventionErtapenem 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. |
| Orphan Drug | no |
| Generics | yes |
| Marketing Authorization Holder | SUN Pharmaceutical Industries (Europe) B.V. |
| Status | Authorised(授权) |
| Authorization Date | 2022-07-15 |
| Version | 0 |
| Condition Approval | no |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information