Details for: ALUNBRIG


Product description

Product name: ALUNBRIG

Company name: TAKEDA CANADA INC

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.