Details for: FORXIGA
Product description
Product name: FORXIGA
Company name: ASTRAZENECA CANADA INC
DIN: 02435462
Status: Marketed
Status date: 2015-01-16
Active ingredient(s) | Strength |
---|---|
DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) | 5 MG |
Resources
Click on a resource to visit a page with more information. You may be taken away from this page to a different Government of Canada website.
For consumers
Resource | Description |
---|---|
Product Monograph |
The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use. The Product Monograph includes three sections:
|
Regulatory Decision Summary for Forxiga |
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision. |
Summary Safety Review - Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors (canagliflozin, dapagliflozin, empagliflozin) - Assessing the Potential Risks of Prolonged or Incident Diabetic Ketoacidosis Despite Stopping Treatment in Adult Patients with Type 2 Diabetes |
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any. |
Report a side effect |
Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine. All suspected side effects should be reported, especially those that are:
|
For health care professionals
Resource | Description |
---|---|
Product Monograph |
The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use. The Product Monograph includes three sections:
|
Summary Basis of Decision for Forxiga |
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations. |
Summary Safety Review - Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors (canagliflozin, dapagliflozin, empagliflozin) - Assessing the Potential Risks of Prolonged or Incident Diabetic Ketoacidosis Despite Stopping Treatment in Adult Patients with Type 2 Diabetes |
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any. |
Report a serious adverse drug reaction (for hospitals) |
Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital. This regulatory requirement only applies to hospitals. |
For researchers
Resource | Description |
---|---|
Product Monograph |
The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use. The Product Monograph includes three sections:
|
Summary Basis of Decision for Forxiga |
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations. |
Search Clinical Information | After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes. |
All resources
Resource | Description |
---|---|
Product Monograph |
The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use. The Product Monograph includes three sections:
|
Regulatory Decision Summary for Forxiga |
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision. |
Summary Basis of Decision for Forxiga |
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations. |
Summary Safety Review - Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors (canagliflozin, dapagliflozin, empagliflozin) - Assessing the Potential Risks of Prolonged or Incident Diabetic Ketoacidosis Despite Stopping Treatment in Adult Patients with Type 2 Diabetes |
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any. |
Search Clinical Information | After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes. |
Report a side effect |
Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine. All suspected side effects should be reported, especially those that are:
|
Report a serious adverse drug reaction (for hospitals) |
Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital. This regulatory requirement only applies to hospitals. |
Resource | Description |
---|---|
Product Monograph |
The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use. The Product Monograph includes three sections:
|
Regulatory Decision Summary for Forxiga |
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision. |
Summary Safety Review - Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors (canagliflozin, dapagliflozin, empagliflozin) - Assessing the Potential Risks of Prolonged or Incident Diabetic Ketoacidosis Despite Stopping Treatment in Adult Patients with Type 2 Diabetes |
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any. |
Report a side effect |
Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine. All suspected side effects should be reported, especially those that are:
|