TIVICAY and TIVICAY PD (ViiV Healthcare Pty Ltd)
Product name
TIVICAY and TIVICAY PD
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
218 (255 working days)
Active ingredients
dolutegravir and dolutegravir (as sodium)
Registration type
EOI
Indication
TIVICAY and TIVICAY PD (film-coated tablet and dispersible tablet) are now also indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in adults and children of at least 4 weeks in age or older and weighing 3 kg or more (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, Dual regimens).