HIBRUKA Innocare Pharma Australia Pty Ltd
Product name
HIBRUKA
Accepted date
Mar-2025
Active ingredients
Orelabrutinib
Proposed indication
Hibrukla (orelabrutinib) is used to treat adult patients with mantle cell lymphoma who have received at least one prior therapy. Lymphoma develops when white blood cells (lymphocytes) grow out of control.
Application type
A (new medicine)
Publication date
Mar-2025
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration.