ZAVICEFTA (Pfizer Australia Pty Ltd)
Product name
ZAVICEFTA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
195 (255 working days)
Active ingredients
avibactam sodium; ceftazidime pentahydrate
Registration type
EOI
Indication
ZAVICEFTA (powder for injection) is now also indicated for the treatment of the following infections in infants and paediatric patients (≥ 3 months to < 18 years) (see sections 4.4 Special warnings and precautions for use and 5.1 Pharmacodynamic properties):
- Complicated intra-abdominal infection (cIAI) in combination with metronidazole.
- Complicated urinary tract infection (cUTI) including pyelonephritis