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BRINEURA (BioMarin Pharmaceutical Australia Pty Ltd)
Product name
BRINEURA
Date registered
Evaluation commenced
Decision date
Approval time
129 working days (255)
Active ingredients
cerliponase alfa (rch)
Registration type
NCE/NBE
Indication
BRINEURA (solution for injection) is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
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.