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Details for: FORXIGA

Company: ASTRAZENECA CANADA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02435462FORXIGADAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE)5 MGTABLETORAL
02435470FORXIGADAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE)10 MGTABLETORAL
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Summary Reports

Summary Basis of Decision
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
Summary Safety Review - SGLT2 Inhibitors (canagliflozin, dapagliflozin, empagliflozin) - Assessing the Potential Risk of Bone-Related Side Effects
Summary Safety Review - SGLT2 Inhibitors (canagliflozin, dapagliflozin, empagliflozin) - Assessing the Risk of the Body Producing High Levels of Acids in the Blood (diabetic ketoacidosis)
Summary Safety Review - Sodium Glucose Cotransporter 2 (SGLT2) Inhibitors INVOKANA (canagliflozin) and FORXIGA (dapagliflozin) - Evaluation of a Potential Risk of Acute Kidney Injury
Summary Safety Review - SGLT2 inhibitors - Assessing the potential risk of a rare brain condition (posterior reversible encephalopathy syndrome) in patients who have developed high levels of acids in the blood (diabetic ketoacidosis)
Summary Safety Review - Sodium/glucose cotransporter 2 (SGLT2) inhibitors - Assessing the potential risk of inflammation of the pancreas (acute and chronic pancreatitis)

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