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:

Cancelled Post Market

Current status date:

2021-06-22

Original market date: See footnote 1

2011-03-02

Lot number: See footnote 2

35356356B

Expiry date: See footnote 2

2022-03-30

Product name:

MORPHINE SR

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:

02350912

Product Monograph/Veterinary Labelling:

Date: 2018-12-06 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

SANIS HEALTH INC
1 Presidents Choice Circle
Brampton
Ontario
Canada L6Y 5S5

Class:

Human

Dosage form(s):

Tablet (Extended-Release)

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Narcotic (CDSA I)

 

American Hospital Formulary Service (AHFS): See footnote 3

28:08.08 

Anatomical Therapeutic Chemical (ATC): See footnote 4

N02AA01 MORPHINE

Active ingredient group (AIG) number:See footnote5

0104545010

List of active ingredient(s)
Active ingredient(s) Strength
MORPHINE SULFATE 60 MG

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
Version 4.0.2
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