Discontinuation report ZINBRYTA

Last updated on 2018-03-09 History
Report ID 42342
Drug Identification Number 02459620
Brand name ZINBRYTA
Common or Proper name daclizumab beta
Company Name BIOGEN CANADA INC
Market Status CANCELLED POST MARKET
Active Ingredient(s) DACLIZUMAB BETA
Strength(s) 150MG
Dosage form(s) SOLUTION
Route of administration SUBCUTANEOUS
Packaging size One prefilled syringe for injection
ATC code L04AC
ATC description IMMUNOSUPPRESSANTS
Reason for discontinuation Other (Please describe in comments)
Anticipated discontinuation date 2018-04-30
Actual discontinuation date
Remaining supply date 2018-04-30
Discontinuation status To be discontinued
Discontinuation decision reversal 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.
Health Canada comments
Tier 3 Status No
Contact Address 3250 BLOOR STREET WEST, EAST TOWER, SUITE 1200
TORONTO, ONTARIO
CANADA M8X 2X9
Company contact information

Version History

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Version Number Date Updated Language
v1 2018-03-09 English Compare
v2 2018-03-09 English Compare
v3 2018-03-09 French Compare
v4 2018-03-09 French Compare
v5 2018-03-09 English Compare
v6 2018-03-09 French Compare
v7 2018-03-09 English Compare
v8 2018-03-09 French Compare
v9 2018-03-09 English Compare
v10 2018-03-09 English Compare
v11 2018-03-09 English Compare
v12 2018-03-09 French Compare

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