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Version v12-FR Version v3-FR
Language French French
Date Updated 2018-03-09 2018-03-09
Drug Identification Number 02459620 02459620
Brand name ZINBRYTA ZINBRYTA
Common or Proper name daclizumab beta daclizumab beta
Company Name BIOGEN CANADA INC BIOGEN CANADA INC
Ingredients DACLIZUMAB BETA DACLIZUMAB BETA
Strength(s) 150MG 150MG
Dosage form(s) SOLUTION SOLUTION
Route of administration SUBCUTANEOUS SUBCUTANEOUS
Packaging size One prefilled syringe for injection One prefilled syringe for injection
ATC code L04AC L04AC
ATC description IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS
Reason for discontinuation Other (Please describe in comments) Other (Please describe in comments)
Anticipated discontinuation date 2018-04-30 2018-04-30
Actual discontinuation date
Remaining supply date 2018-04-30 2018-04-30
Discontinuation status To be discontinued To be discontinued
Discontinuation decision reversal no no
Tier 3 Status No No
Information on remaining supply
Company comments Given the nature and complexity of adverse events being reported globally, characterizing the benefit/risk profile of ZINBRYTA will not be possible going forward given the limited number of patients being treated. Therefore, the company believes it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations for ZINBRYTA. Given the nature and complexity of adverse events being reported globally, characterizing the benefit/risk profile of ZINBRYTA will not be possible going forward given the limited number of patients being treated. Therefore, the company believes it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations for ZINBRYTA.
Health Canada comments