RUKOBIA (ViiV Healthcare Pty Ltd)
Product name
RUKOBIA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
191 (255 working days)
Active ingredients
fostemsavir trometamol
Registration type
NCE/NBE
Indication
RUKOBIA (extended release tablet) is indicated in combination with other antiretroviral agents for the treatment of heavily treatment-experienced adults with multidrug-resistant human immunodeficiency virus-1 (HIV-1) infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen due to resistance, intolerance or safety considerations (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).