VORICONAZOLE-AFT (AFT Pharmaceuticals Pty Ltd)
Product name
VORICONAZOLE-AFT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
112 (255 working days)
Active ingredients
voriconazole
Registration type
New generic medicine
Indication
Voriconazole-AFT (powder for injection) is indicated for treatment of the following fungal infections:
Invasive aspergillosis.
Serious Candida infections (including C. krusei), including systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).
Serious fungal infections caused by Scedosporium spp and Fusarium spp.
Other serious fungal infections, in patients intolerant of, or refractory to, other therapy.
Prophylaxis in patients who are at high risk of developing invasive fungal infections. The indication is based on studies including patients undergoing haematopoietic stem cell transplantation.