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HIBRUKA (Innocare Pharma Australia Pty Ltd)
Product name
HIBRUKA
Date registered
Evaluation commenced
Decision date
Approval time
172 (255 working days)
Active ingredients
orelabrutinib
Registration type
NCE/NBE
Indication
HIBRUKA has provisional approval in Australia for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The decision to approve this indication has been made on the basis of overall response rate (ORR). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.