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TRADENAME Gilead Sciences Pty Ltd
Product name
TRADENAME
Sponsor
Accepted date
Jun-2025
Active ingredients
lenacapavir sodium
Proposed indication
Lenacapavir sodium is taken by HIV negative individuals to prevent sexually-acquired HIV infection. It is a form of pre exposure prophylaxis (PrEP) in adults and adolescents weighing at least 35 kg.
Application type
C (new indication)
Publication date
Jun-2025
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available.