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ENRYLAZE (Jazz Pharmaceuticals ANZ Pty Ltd)
Product name
ENRYLAZE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
162 (175 working days)
Active ingredients
crisantaspase
Registration type
NCE/ NBE
Indication
Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen, for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and paediatric patients (1 month and older) who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.