ARX-NALTREXONE (Accord Healthcare Pty Ltd)
Product name
ARX-NALTREXONE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
128 (255 working days)
Active ingredients
Naltrexone hydrochloride
Registration type
New generic medicine
Indication
NALTREXONE INTAS is indicated for use within a comprehensive treatment program for alcohol dependence.
NALTREXONE INTAS is also indicated as adjunctive therapy in the maintenance of formerly opioid-dependent patients who have ceased the use of opioids such as diamorphine (heroin) and morphine.