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VOCABRIA (ViiV Healthcare Pty Ltd)
Product name
VOCABRIA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
253 (255 workign days)
Active ingredients
cabotegravir
Registration type
NCE/NBE
Indication
VOCABRIA (tablet) are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) and have no known or suspected resistance to either cabotegravir or rilpivirine (see sections 4.2 DOSE AND METHOD OF ADMINISTRATION and 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials) for:
- oral lead in to assess tolerability of cabotegravir prior to administration of cabotegravir prolonged-release suspension for injection plus rilpivirine prolonged-release suspension for injection.
- oral therapy for adults who will miss planned dosing with cabotegravir prolonged-release suspension for injection.