CRESEMBA (Pfizer Australia Pty Ltd)
Product name
CRESEMBA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
139 (255 working days)
Active ingredients
isavuconazonium sulfate
Registration type
EOI
Indication
CRESEMBA is indicated in adults and paediatric patients from 1 year of age for the treatment of
- invasive aspergillosis
- mucormycosis in patients for whom amphotericin B is inappropriate (see Section 4.4 Special warnings and precautions for use and Section 5.1 Pharmacodynamic properties)
Consideration should be given to official guidance on the appropriate use of antifungal agents.