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Version v29-FR Version v18-FR
Language French French
Date Updated 2019-01-10 2018-08-09
Drug Identification Number 02224623 02224623
Brand name SOFRACORT STERILE EAR/EYE DROPS SOFRACORT STERILE EAR/EYE DROPS
Common or Proper name Sofracort Sterile Ear/Eye Drops Sofracort Sterile Ear/Eye Drops
Company Name SANOFI-AVENTIS CANADA INC SANOFI-AVENTIS CANADA INC
Ingredients DEXAMETHASONE GRAMICIDIN FRAMYCETIN SULFATE DEXAMETHASONE GRAMICIDIN FRAMYCETIN SULFATE
Strength(s) 0.5MG 0.05MG 5MG 0.5MG 0.05MG 5MG
Dosage form(s) DROPS DROPS
Route of administration OPHTHALMIC OTIC OPHTHALMIC OTIC
Packaging size 8 mL 8 mL
ATC code S03CA S03CA
ATC description CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION
Reason for shortage Other (Please describe in comments) Other (Please describe in comments)
Anticipated start date 2017-05-15 2017-05-15
Actual start date 2017-05-15
Estimated end date 2018-12-14 2018-10-31
Actual end date 2018-12-18
Shortage status Resolved Actual shortage
Tier 3 Status No No
Company comments Production delay Production delay
Health Canada comments