Skip to main content

CIPFOSIN/ CIPLA FOSFOMYCIN (Cipla Australia Pty Ltd)

Product name
CIPFOSIN/ CIPLA FOSFOMYCIN
Date registered
Evaluation commenced
Decision date
Approval time
122 (255 working days)
Active ingredients
fosfomycin trometamol
Registration type
New generic medicine
Indication

CIPFOSIN/ CIPLA FOSFOMYCIN is indicated only for the treatment of acute uncomplicated lower urinary tract infections (acute cystitis) in females above 12 years of age caused by the following susceptible pathogens: Escherichia coli, or Enterococcus faecalis.

CIPFOSIN/ CIPLA FOSFOMYCIN is not indicated for the treatment of pyelonephritis or perinephric abscess or where resistance is likely (previous treatment failure, infection due to non-susceptible organism).

Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to CIPFOSIN/ CIPLA FOSFOMYCIN. However, therapy may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. Consideration should be given to the relevant clinical guidelines on the appropriate use of antibacterial agents.

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine

Help us improve the Therapeutic Goods Administration site