← Drug database

Zerbaxa (ceftolozane;tazobactam)

Region
🇪🇺 EU
Active substance
ceftolozane;tazobactam
Company
Merck Sharp & Dohme B.V.
Status
Authorised
Therapeutic area
Bacterial Infections
CHMP opinion
Thu 23 Jul 2015
EU approval
Fri 18 Sep 2015
Application
EMEA/H/C/003772
ATC
J01DI54
Official record
www.ema.europa.eu

Indication

Zerbaxa is indicated for the treatment of the following infections in adults: Complicated intra abdominal infections; Acute pyelonephritis; Complicated urinary tract infections; Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Regulatory milestones

No milestones recorded in the last year.

Follow Zerbaxa

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.