POSACONAZOLE SANDOZ (Sandoz Pty Ltd)
Product name
POSACONAZOLE SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
117 working days (255)
Active ingredients
posaconazole
Registration type
New generic medicine
Indication
POSACONAZOLE SANDOZ (modified release tablet) 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.
POSACONAZOLE SANDOZ is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine