YEYTUO (Gilead Sciences Pty Ltd)
Product name
YEYTUO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
118 (255 working days)
Active ingredients
lenacapavir sodium
Registration type
EOI
Indication
YEYTUO is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents 16 years and older weighing at least 35 kg.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available