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Version v5-FR Version v2-FR
Language French French
Date Updated 2017-10-10 2017-03-20
Drug Identification Number 02273225 02273225
Brand name ENABLEX ENABLEX
Common or Proper name Darifenacin Darifenacin
Company Name SEARCHLIGHT PHARMA INC SEARCHLIGHT PHARMA INC
Ingredients DARIFENACIN DARIFENACIN
Strength(s) 15MG 15MG
Dosage form(s) TABLET (EXTENDED-RELEASE) TABLET (EXTENDED-RELEASE)
Route of administration ORAL ORAL
Packaging size 28 28
ATC code G04BD G04BD
ATC description OTHER UROLOGICALS, INCL ANTISPASMODICS OTHER UROLOGICALS, INCL ANTISPASMODICS
Reason for shortage Other (Please describe in comments) Other (Please describe in comments)
Anticipated start date 2017-10-01 2017-10-01
Actual start date
Estimated end date Unknown Unknown
Actual end date 2017-10-06
Shortage status Resolved Anticipated shortage
Company comments The current manufacturer Novartis, has stopped production of enablex 7.5mg and 15mg tablets in 2016. The company Merus Labs Luxco SaRL has submitted a variation to register a new formulation for on the 4 December 2016, the formulation is already currently approved for the generic product with a declaration of equivalence to Enablex. This variation is ongoing.
Health Canada comments