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 v28-FR | Version v19-FR | |
|---|---|---|
| Language | French | French |
| Date Updated | 2024-04-23 | 2023-11-15 |
| Drug Identification Number | 02068036 | 02068036 |
| Brand name | SABRIL | SABRIL |
| Common or Proper name | vigabatrin powder for oral solution | vigabatrin powder for oral solution |
| Company Name | LUNDBECK PHARMACEUTICALS LLC | LUNDBECK PHARMACEUTICALS LLC |
| Ingredients | VIGABATRIN | VIGABATRIN |
| Strength(s) | 500MG | 500MG |
| Dosage form(s) | POWDER FOR SOLUTION | POWDER FOR SOLUTION |
| Route of administration | ORAL ORAL | ORAL ORAL |
| Packaging size | Cartons of 50 | Cartons of 50 |
| ATC code | N03AG | N03AG |
| ATC description | ANTIEPILEPTICS | ANTIEPILEPTICS |
| Reason for shortage | Disruption of the manufacture of the drug. | Disruption of the manufacture of the drug. |
| Anticipated start date | 2023-06-01 | 2023-06-01 |
| Actual start date | 2023-07-27 | 2023-07-27 |
| Estimated end date | 2024-05-15 | Unknown |
| Actual end date | 2024-04-22 | |
| Shortage status | Resolved | Actual shortage |
| Tier 3 Status | Yes | No |
| Company comments | Lundbeck Canada has ceased the sale of Sabril sachets as there may be an alternative available. To help mitigate the ongoing shortage, Health Canada is working with stakeholders to monitor the supply of sachets and has permitted the importation of foreign-authorized vigabatrin sachets. Please see Health Canada’s List of drugs for exceptional importation and sale for information related to the availability of alternative supply. | Additional units of lot 3214708A are available and could be released for distribution; however, for now, Lundbeck has not received permission from Health Canada to release additional units. Lundbeck Canada has ceased the sale of Sabril sachets as there may be an alternative available. Recently, Health Canada has permitted the importation of foreign-authorized vigabatrin sachets to minimize impacts of the shortage. To help mitigate the ongoing shortage, Health Canada is working with stakeholders to monitor the supply of sachets. Please see Health Canada’s List of drugs for exceptional importation and sale for information related to the availability of alternative supply. |
| Health Canada comments |