Discontinuation report FIBRISTAL
| Report ID | 125735 |
| Drug Identification Number | 02408163 |
| Brand name | FIBRISTAL |
| Common or Proper name | Fibristal |
| Company Name | ALLERGAN INC |
| Market Status | CANCELLED POST MARKET |
| Active Ingredient(s) | ULIPRISTAL ACETATE |
| Strength(s) | 5MG |
| Dosage form(s) | TABLET |
| Route of administration | ORAL ORAL |
| Packaging size | 30 tablets |
| ATC code | G03XB |
| ATC description | OTHER SEX HORM. & MODULATORS OF THE GENITAL SYSTEM |
| Reason for discontinuation | Other (Please describe in comments) |
| Anticipated discontinuation date | |
| Actual discontinuation date | 2020-09-24 |
| Remaining supply date | 2020-09-24 |
| Discontinuation status | Discontinued |
| Discontinuation decision reversal | 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. |
| Health Canada comments | |
| Tier 3 Status | No |
| Company contact information | Company contact information; Telephone number: 800-668-6424 Email address: MR-GENERAL_INQUIRY@allergan.com Website address: allergan.ca Postal address: 500-85 Enterprise Blvd, Markham, Ontario, L6G 0B5 |
Version History
Click on "Compare" below to view the full report history and compare to other versions.
| Version Number | Date Updated | Language | |
|---|---|---|---|
| v2 | 2020-10-06 | French | Compare |
| v1 | 2020-10-06 | English | Compare |
Showing 1 to 2 of 2