POSAONE (Seed Pharma Pty Ltd)
Product name
POSAONE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
111 (255 working days)
Active ingredients
posaconazole
Registration type
New generic medicine
Indication
POSAONE (posaconazole) concentrated injection is indicated for use in the treatment of the following invasive fungal infections in adults:
- 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.
POSAONE is also indicated for the:
- Prophylaxis of invasive fungal infections among adults, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.