KOZENIS (GlaxoSmithKline Australia Pty Ltd)
Product name
KOZENIS
Date registered
Evaluation commenced
Decision date
Approval time
147 working days (255)
Active ingredients
tafenoquine succinate
Registration type
NCE/NBE
Indication
KOZENIS (film coated tablets) is indicated for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for the acute P. vivax infection.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.