Drug Report History
Below you will find the report version history. When a report is updated, a new version of the report is created. The report history allows you to see the changes between versions. You can select two versions of the report to compare. The fields that were changed between versions will be highlighted in yellow.
The translation of reports creates two separate versions which is why some reports may not seem to have any differences. In this case, only the language field below will be highlighted in yellow.
Version v4-EN | Version v2-FR | |
---|---|---|
Language | English | 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 |
Tier 3 Status | No | No |
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 |