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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

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

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)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

48:08.00   ANTITUSSIVES

Anatomical Therapeutic Chemical (ATC): See footnote 4

R05FA02  OPIUM DERIVATIVES AND EXPECTORANTS

Active ingredient group (AIG) number:See footnote 5

0321611001

List of active ingredient(s)
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

Application information

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