POSACONAZOLE MEDSURGE (Medsurge Pharma Pty Ltd)
Product name
POSACONAZOLE MEDSURGE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
121 (255 working days)
Active ingredients
posaconazole
Registration type
New generic medicine
Indication
[TRADE NAME] (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older:
- Invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy.
- Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.