KOZENIS (GlaxoSmithKline Australia Pty Ltd)
Product name
KOZENIS
Date registered
Evaluation commenced
Decision date
Approval time
250 (255 working days)
Active ingredients
tafenoquine succinate
Registration type
EOI
Indication
KOZENIS (film-coated dispersible tablet) is indicated, in combination with chloroquine, for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria (see Section 4.2 Dose and Method of Administration).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.