Discontinuation report FIBRISTAL

Last updated on 2020-10-06 History
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

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