Discontinuation report ZINBRYTA
| 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 | 3300 BLOOR STREET WEST, WEST TOWER, SUITE 1200 TORONTO, ONTARIO CANADA M8X 2X2 |
| 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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