Emblaveo (aztreonam;avibactam)
- Region
- 🇪🇺 EU
- Active substance
- aztreonam;avibactam
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Gram-Negative Bacterial Infections; Urinary Tract Infections; Healthcare-Associated Pneumonia; Soft Tissue Infections
- CHMP opinion
- Thu 21 Mar 2024
- EU approval
- Mon 22 Apr 2024
- Application
- EMEA/H/C/006113
- ATC
- J01DF51
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
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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.