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 v2-FR | Version v1-EN | |
|---|---|---|
| Language | French | English |
| Date Updated | 2020-10-06 | 2020-10-06 |
| Drug Identification Number | 02408163 | 02408163 |
| Brand name | FIBRISTAL | FIBRISTAL |
| Common or Proper name | Fibristal | Fibristal |
| Company Name | ALLERGAN INC | ALLERGAN INC |
| Ingredients | ULIPRISTAL ACETATE | ULIPRISTAL ACETATE |
| Strength(s) | 5MG | 5MG |
| Dosage form(s) | TABLET | TABLET |
| Route of administration | ORAL ORAL | ORAL ORAL |
| Packaging size | 30 tablets | 30 tablets |
| ATC code | G03XB | G03XB |
| ATC description | OTHER SEX HORM. & MODULATORS OF THE GENITAL SYSTEM | OTHER SEX HORM. & MODULATORS OF THE GENITAL SYSTEM |
| Reason for discontinuation | Other (Please describe in comments) | Other (Please describe in comments) |
| Anticipated discontinuation date | ||
| Actual discontinuation date | 2020-09-24 | 2020-09-24 |
| Remaining supply date | 2020-09-24 | 2020-09-24 |
| Discontinuation status | Discontinued | Discontinued |
| Discontinuation decision reversal | no | no |
| Tier 3 Status | No | No |
| Information on remaining supply | ||
| Company comments | Allergan has reviewed the benefits and risks for FIBRISTAL® following reports of rare cases of severe liver injury requiring liver transplantation in Europe and has decided to remove the medication from the Canadian market. | Allergan has reviewed the benefits and risks for FIBRISTAL® following reports of rare cases of severe liver injury requiring liver transplantation in Europe and has decided to remove the medication from the Canadian market. |
| Health Canada comments |