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 v33-FR | Version v20-FR | |
|---|---|---|
| Language | French | French |
| Date Updated | 2024-03-27 | 2023-11-06 |
| Drug Identification Number | 02065819 | 02065819 |
| Brand name | SABRIL | SABRIL |
| Common or Proper name | vigabatrin tablet | vigabatrin tablet |
| Company Name | LUNDBECK PHARMACEUTICALS LLC | LUNDBECK PHARMACEUTICALS LLC |
| Ingredients | VIGABATRIN | VIGABATRIN |
| Strength(s) | 500MG | 500MG |
| Dosage form(s) | TABLET | TABLET |
| Route of administration | ORAL ORAL | ORAL ORAL |
| Packaging size | Blister strips of 10 tablets in cartons containing 10 strips (100 tablets) and in bottles containing 100 tablets | Blister strips of 10 tablets in cartons containing 10 strips (100 tablets) and in bottles containing 100 tablets |
| ATC code | N03AG | N03AG |
| ATC description | ANTIEPILEPTICS | ANTIEPILEPTICS |
| Reason for shortage | Requirements related to complying with good manufacturing practices. | Requirements related to complying with good manufacturing practices. |
| Anticipated start date | 2023-03-31 | 2023-03-31 |
| Actual start date | 2023-03-15 | 2023-03-15 |
| Estimated end date | 2024-04-15 | Unknown |
| Actual end date | 2024-03-26 | |
| Shortage status | Resolved | Actual shortage |
| Tier 3 Status | No | No |
| Company comments | Lundbeck Canada has ceased the sale of Sabril tablets as there may be an alternative available. To help mitigate the ongoing shortage, Health Canada is working with stakeholders to monitor the supply of tablets and has permitted the importation of foreign-authorized vigabatrin tablets. Please see Health Canada’s List of drugs for exceptional importation and sale for information related to the availability of alternative supply. | Exceptional import application was submitted and approved for importation of US labelled Sabril 500mg tablets. Very limited orders (500 units) for the US-labelled Sabril Tablets arrived at Ashfield Healthcare. Additionally, per the advice of Health Canada, very limited units of tablets (432 of lot 3216947) containing traces of tiapride were released for distribution on 01November2023. |
| Health Canada comments |