Drug Report History
Below you will find the report version history. When a report is updated, a new version of the report is created. The report history allows you to see the changes between versions. You can select two versions of the report to compare. The fields that were changed between versions will be highlighted in yellow.
The translation of reports creates two separate versions which is why some reports may not seem to have any differences. In this case, only the language field below will be highlighted in yellow.
| Version v9-EN | Version v9-EN | |
|---|---|---|
| Language | English | English |
| Date Updated | 2023-11-18 | 2023-11-18 |
| Drug Identification Number | 02435268 | 02435268 |
| Brand name | BIVALIRUDIN FOR INJECTION | BIVALIRUDIN FOR INJECTION |
| Common or Proper name | BIVALIRUDIN FOR INJECTION | BIVALIRUDIN FOR INJECTION |
| Company Name | FRESENIUS KABI CANADA LTD | FRESENIUS KABI CANADA LTD |
| Ingredients | BIVALIRUDIN | BIVALIRUDIN |
| Strength(s) | 250MG | 250MG |
| Dosage form(s) | POWDER FOR SOLUTION | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS INTRAVENOUS | INTRAVENOUS INTRAVENOUS |
| Packaging size | 10mL | 10mL |
| ATC code | B01AE | B01AE |
| ATC description | ANTITHROMBOTIC AGENTS | ANTITHROMBOTIC AGENTS |
| Reason for shortage | Disruption of the manufacture of the drug. | Disruption of the manufacture of the drug. |
| Anticipated start date | ||
| Actual start date | 2023-07-21 | 2023-07-21 |
| Estimated end date | 2023-11-30 | 2023-11-30 |
| Actual end date | 2023-11-17 | 2023-11-17 |
| Shortage status | Resolved | Resolved |
| Tier 3 Status | No | No |
| Company comments | Fresenius Kabi Canada regrets to advise that due to production delays, we will be encountering a supply interruption on our Bivalirudin for Injection 250 mg/vial SD Vial 10 mL effective July 21, 2023, until November 30, 2023. Sandoz is an alternate supplier of Bivalirudin and have been informed of our impending supply interruption. | Fresenius Kabi Canada regrets to advise that due to production delays, we will be encountering a supply interruption on our Bivalirudin for Injection 250 mg/vial SD Vial 10 mL effective July 21, 2023, until November 30, 2023. Sandoz is an alternate supplier of Bivalirudin and have been informed of our impending supply interruption. |
| Health Canada comments |