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CABENUVA (ViiV Healthcare Pty Ltd)
Product name
CABENUVA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
231 (255 working days)
Active ingredients
cabotegravir; rilpivirine
Registration type
EOI
Indication
New combination
CABENUVA (suspension for injection) is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies per mL) and have no known or suspected resistance to either cabotegravir or rilpivirine (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials).