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VORIZOLE PFS GPPL, ZOLENS PFS, VORIZOLE PFS, VZOLE PFS, VORICONAZOLE PFS GenPar, VORICONAZOLE PFS (Generic Partners Pty Ltd)
Product name
VORIZOLE PFS GPPL, ZOLENS PFS, VORIZOLE PFS, VZOLE PFS, VORICONAZOLE PFS GenPar, VORICONAZOLE PFS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
125 working days (255)
Active ingredients
voriconazole
Registration type
New generic medicine
Indication
VORIZOLE PFS GPPL, ZOLENS PFS, VORIZOLE PFS, VZOLE PFS, VORICONAZOLE PFS GenPar, VORICONAZOLE PFS (powder for oral suspension) are indicated for treatment of the following fungal infections:
- Invasive aspergillosis
- Serious Candida infections (including C. krusei), including oesophageal and systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).
- Serious fungal infections caused by Scedoosporium 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.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine