FORXIGA (AstraZeneca Pty Ltd)
Product name
FORXIGA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
184 working days (255)
Active ingredients
dapagliflozin propanediol monohydrate
Registration type
EOI
Indication
Prevention of hospitalisation for heart failure
FORXIGA (film coated tablets) is now also indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 Pharmacodynamic properties - Clinical trials).