DOVATO (ViiV Healthcare Pty Ltd)
Product name
DOVATO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
170 working days (255)
Active ingredients
dolutegravir sodium; lamivudine
Registration type
EOI
Indication
DOVATO (film coated tablet) is now also indicated to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to the integrase inhibitor class or lamivudine (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials).