| Report ID |
125735 |
| Drug Identification Number |
02408163 |
| Brand name |
FIBRISTAL |
| Common or Proper name |
Fibristal |
| Company Name |
ALLERGAN INC |
| Market Status |
MARKETED |
| 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 |
|
| 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 |
