Details for: TECARTUS - Drug and Health Products Portal

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Product description

Product name: TECARTUS

Company name: GILEAD SCIENCES CANADA INC

DIN: 02516667

Status: Marketed

Status date: 2021-12-16

Active ingredient(s)	Strength
BREXUCABTAGENE AUTOLEUCEL	200000000 CELLS / BAG

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.

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: Part I: Health Professional Information; Part II: Scientific Information; and Patient Medication Information
Regulatory Decision Summary for Tecartus	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 - Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel) - Chimeric Antigen Receptor T-cell (CAR-T) Therapies - Assessing the Potential Risk of Secondary T-cell Malignancy	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: 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.

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: Part I: Health Professional Information; Part II: Scientific Information; and Patient Medication Information
Summary Basis of Decision for Tecartus	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 - Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel) - Chimeric Antigen Receptor T-cell (CAR-T) Therapies - Assessing the Potential Risk of Secondary T-cell Malignancy	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.

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: Part I: Health Professional Information; Part II: Scientific Information; and Patient Medication Information
Summary Basis of Decision for Tecartus	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.

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: Part I: Health Professional Information; Part II: Scientific Information; and Patient Medication Information
Regulatory Decision Summary for Tecartus	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 Tecartus	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 - Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel) - Chimeric Antigen Receptor T-cell (CAR-T) Therapies - Assessing the Potential Risk of Secondary T-cell Malignancy	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: 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.
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: Part I: Health Professional Information; Part II: Scientific Information; and Patient Medication Information
Regulatory Decision Summary for Tecartus	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 - Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel) - Chimeric Antigen Receptor T-cell (CAR-T) Therapies - Assessing the Potential Risk of Secondary T-cell Malignancy	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: 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.

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: Part I: Health Professional Information; Part II: Scientific Information; and Patient Medication Information
Summary Basis of Decision for Tecartus	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 - Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel) - Chimeric Antigen Receptor T-cell (CAR-T) Therapies - Assessing the Potential Risk of Secondary T-cell Malignancy	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.

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: Part I: Health Professional Information; Part II: Scientific Information; and Patient Medication Information
Summary Basis of Decision for Tecartus	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.

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: Part I: Health Professional Information; Part II: Scientific Information; and Patient Medication Information
Regulatory Decision Summary for Tecartus	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 Tecartus	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 - Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel) - Chimeric Antigen Receptor T-cell (CAR-T) Therapies - Assessing the Potential Risk of Secondary T-cell Malignancy	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: 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.
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.