Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Dormant
Current status date:
2022-07-28
Original market date: See footnote 1
1997-01-23
Product name:
COPHYLAC
DIN:
02224577
Product Monograph/Veterinary Labelling:
Date:
2020-06-24
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BAUSCH HEALTH, CANADA INC.
2150 Boul. St-Elzear Ouest
Laval
Quebec
Canada
H7L 4A8
Class:
Human
Dosage form(s):
Drops
Route(s) of administration:
Oral
Number of active ingredient(s):
2
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
48:08.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
R05DA20 COMBINATIONS
Active ingredient group (AIG) number:See footnote5
0204869001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| NORMETHADONE HYDROCHLORIDE | 10 MG / ML |
| P-HYDROXYEPHEDRINE HYDROCHLORIDE | 20 MG / ML |
Risk Management Plans See footnote 7
A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.