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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:

2019-12-17

Original market date: See footnote 1

2019-12-17

Product name:

MORPHINE SULFATE INJECTION, USP

Description:

SINGLE USE VIAL, PRESERVATIVE FREE

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:

02482681

Product Monograph/Veterinary Labelling:

Date: 2018-11-13 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

FRESENIUS KABI CANADA LTD
165 Galaxy Blvd, Suite 100
Toronto
Ontario
Canada  M9W 0C8

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous,  Subcutaneous,  Intramuscular

Number of active ingredient(s):

1

Schedule(s):

Narcotic (CDSA I)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:08.08   OPIATE AGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N02AA01  MORPHINE

Active ingredient group (AIG) number:See footnote 5

0104545008

List of active ingredient(s)
Active ingredient(s) Strength
MORPHINE SULFATE 2 MG / 1 ML

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