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FORXIGA (AstraZeneca Pty Ltd)
Product name
FORXIGA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
246 (255 working days)
Active ingredients
dapagliflozin propanediol monohydrate
Registration type
EOI
Indication
Chronic kidney disease
FORXIGA is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (CKD Stage 2,3 or 4 and urine ACR ≥ 20 mg/mmol).