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XIGDUO XR (AstraZeneca Pty Ltd)
Product name
XIGDUO XR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
184 working days (255)
Active ingredients
dapagliflozin propanediol monohydrate; metformin hydrochloride
Registration type
EOI
Indication
Prevention of hospitalisation for heart failure
XIGDUO XR (modified release tablets) is 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.