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:
Marketed
Current status date:
2013-05-03
Original market date: See footnote 1
1996-08-30
Product name:
CALMYLIN PSE WITH CODEINE
DIN:
02172917
Product Monograph/Veterinary Labelling:
Date:
2013-11-20
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
TEVA CANADA LIMITED
30 Novopharm Court
Toronto
Ontario
Canada
M1B 2K9
Class:
Human
Dosage form(s):
Syrup
Route(s) of administration:
Oral
Number of active ingredient(s):
3
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
48:08.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
R05FA02 OPIUM DERIVATIVES AND EXPECTORANTS
Active ingredient group (AIG) number:See footnote5
0321611001
| Active ingredient(s) | Strength |
|---|---|
| CODEINE PHOSPHATE | 3.3 MG / 5 ML |
| GUAIFENESIN | 100 MG / 5 ML |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 30 MG / 5 ML |
Risk Management Plans See footnote 7
A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |