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QARZIBA (Emerge Health Pty Ltd)
Product name
QARZIBA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
137 working days (255)
Active ingredients
dinutuximab beta
Registration type
NCE/NBE
Indication
QARZIBA (concentrated solution for injection) is indicated for the treatment of high-risk neuroblastoma in patients who have previously received induction chemotherapy and achieved at least a partial response.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.