Details for: LUXTURNA

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:

• Part I: Health Professional Information;
• Part II: Scientific Information; and
• Patient Medication Information

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.

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:

• Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
• Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
• Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.

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:

• Part I: Health Professional Information;
• Part II: Scientific Information; and
• Patient Medication Information

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.

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.

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:

• Part I: Health Professional Information;
• Part II: Scientific Information; and
• Patient Medication Information

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.

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:

• Part I: Health Professional Information;
• Part II: Scientific Information; and
• Patient Medication Information

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.

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.

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:

• Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
• Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
• Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.

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.