JULUCA (ViiV Healthcare Pty Ltd)
Product name
JULUCA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
169 working days (255)
Active ingredients
rilpivirine hydrochloride; dolutegravir
Registration type
EOI
Indication
New combination
JULUCA (tablets) is now also indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.