ZAVICEFTA (Pfizer Australia Pty Ltd)
Product name
ZAVICEFTA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
161 working days (175 COR-B)
Active ingredients
avibactam sodium; ceftazidime pentahydrate
Registration type
EOI
Indication
New combination
ZAVICEFTA (powder for injection) is indicated for the treatment of the following infections in adults:
- Complicated intra-abdominal infection (cIAI), in combination with metronidazole.
- Complicated urinary tract infection (cUTI), including pyelonephritis.
- Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).
Consideration should be given to official guidance on the appropriate use of antibacterial agents. ZAVICEFTA should be used in combination with an antibacterial agent(s) active against Gram-positive and/or anaerobic pathogens when these are known or suspected to be contributing to the infectious process.