Ertapenem SUN (ertapenem)
- Region
- 🇪🇺 EU
- Active substance
- ertapenem
- Company
- SUN Pharmaceutical Industries (Europe) B.V.
- Status
- Authorised
- Therapeutic area
- Bacterial Infections
- CHMP opinion
- Thu 19 May 2022
- EU approval
- Fri 15 Jul 2022
- Designations
- Generic
- Application
- EMEA/H/C/005815
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Invanz Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 Ertapenem Hospira Application withdrawn · Hospira UK Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.