We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
PALYNZIQ (BioMarin Pharmaceutical Australia Pty Ltd)
Product name
PALYNZIQ
Date registered
Evaluation commenced
Decision date
Approval time
166 (175 working days)
Active ingredients
pegvaliase
Registration type
NCE/NBE
Indication
PALYNZIQ (solution for injection, pre-filled syringe) is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control despite prior management with available treatment options.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.