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.