Exblifep (cefepime;enmetazobactam)
- Region
- 🇪🇺 EU
- Active substance
- cefepime;enmetazobactam
- Company
- Advanz Pharma Limited
- Status
- Authorised
- Therapeutic area
- Urinary Tract Infections; Pyelonephritis; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated
- CHMP opinion
- Thu 25 Jan 2024
- EU approval
- Thu 21 Mar 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005431
- ATC
- J01DE51
- Official record
- www.ema.europa.eu
Indication
Exblifep is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1): - Complicated urinary tract infections (cUTI), including pyelonephritis - Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Regulatory milestones
No milestones recorded in the last year.
Follow Exblifep
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.