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FETROJA (Accelagen Pty Ltd)

Product name
FETROJA
Date registered
Evaluation commenced
Decision date
Approval time
252 (255 working days)
Active ingredients
cefiderocol sulfate tosilate
Registration type
NCE/NBE
Indication

Fetroja is indicated for the treatment of infections due to proven or strongly suspected carbapenem-resistant aerobic Gram-negative organisms in adults with limited treatment options, noting the spectrum of activity of cefiderocol and clinical data (Section 5.1 Pharmacodynamic properties) and special warnings (Section 4.4 Special warnings and precautions for use):

Complicated urinary tract infections (cUTIs), including pyelonephritis Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia

Consideration should be given to official guidance on the appropriate use of antibacterial agents. It is recommended that Fetroja should be used after consultation with a physician with appropriate experience in the management of infectious diseases.