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 |