DARUNAVIR SANDOZ (Sandoz Pty Ltd)
Product name
DARUNAVIR SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
106 (255 working days)
Active ingredients
darunavir
Registration type
New generic medicine
Indication
Adult patients
DARUNAVIR SANDOZ (film-coated tablet) (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adult patients.
Paediatric patients
DARUNAVIR SANDOZ (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.