Details for: ALUNBRIG

Product description

Product name: ALUNBRIG

DIN: 02479230

Status: Marketed

Status date: 2018-08-31

Active ingredient(s)	Strength
BRIGATINIB	90 MG
BRIGATINIB	180 MG

Resources

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For consumers

Resource	Description
Regulatory Decision Summary for Alunbrig	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.
Regulatory Decision Summary for Alunbrig	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.
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.

For health care professionals

Resource	Description
Summary Basis of Decision for Alunbrig	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.
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
Summary Basis of Decision for Alunbrig	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
Regulatory Decision Summary for Alunbrig	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.
Regulatory Decision Summary for Alunbrig	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 Alunbrig	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.
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
Regulatory Decision Summary for Alunbrig	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.
Regulatory Decision Summary for Alunbrig	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.
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
Summary Basis of Decision for Alunbrig	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
Summary Basis of Decision for Alunbrig	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
Regulatory Decision Summary for Alunbrig	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.
Regulatory Decision Summary for Alunbrig	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 Alunbrig	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.
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.

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Details for: ALUNBRIG

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