Zavicefta (ceftazidime;avibactam)
- Region
- 🇪🇺 EU
- Active substance
- ceftazidime;avibactam
- Company
- Pfizer Ireland Pharmaceuticals Unlimited Company
- Status
- Authorised
- Therapeutic area
- Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections
- CHMP opinion
- Thu 28 Apr 2016
- EU approval
- Thu 23 Jun 2016
- Application
- EMEA/H/C/004027
- ATC
- J01DD52
- Official record
- www.ema.europa.eu
Indication
Zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections: Complicated intra-abdominal infection (cIAI) Complicated urinary tract infection (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. Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. 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.