Details for: XIGDUO
Company: ASTRAZENECA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02449935 | XIGDUO | DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE); METFORMIN HYDROCHLORIDE | 5 MG; 850 MG | TABLET | ORAL |
| 02449943 | XIGDUO | DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE); METFORMIN HYDROCHLORIDE | 5 MG; 1000 MG | TABLET | ORAL |
Summary Reports
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)
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)
Consumer Information
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