Details for: TEVA-DIMETHYL FUMARATE
Product description
Product name: TEVA-DIMETHYL FUMARATE
Company name: TEVA CANADA LIMITED
DIN: 02493586
Status: Approved
Status date: 2021-10-04
Active ingredient(s) | Strength |
---|---|
DIMETHYL FUMARATE | 120 MG |
Resources
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For consumers
Resource | Description |
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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 Safety Review - Dimethyl Fumarate - Assessing the Potential Risk of Fanconi Syndrome |
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 Safety Review - Dimethyl Fumarate - Assessing the Potential Risk of Fanconi Syndrome |
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:
|
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:
|
Summary Safety Review - Dimethyl Fumarate - Assessing the Potential Risk of Fanconi Syndrome |
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:
|
Summary Safety Review - Dimethyl Fumarate - Assessing the Potential Risk of Fanconi Syndrome |
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:
|