CRESEMBA (Pfizer Australia Pty Ltd)
Product name
CRESEMBA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
172 working days (175)
Active ingredients
isavuconasole
Registration type
NCE/NBE
Indication
CRESEMBA (capsules) is indicated in adults 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.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.