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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:

2013-05-08

Original market date: See footnote 1

2013-05-08

Product name:

DEXAMETHASONE OMEGA UNIDOSE

Description:

1 ML SINGLE USE VIALS.

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:

02387743

Product Monograph/Veterinary Labelling:

Date: 2012-06-12 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

OMEGA LABORATORIES LTD
11177 Hamon
Montreal
Quebec
Canada  H3M 3E4

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous,  Intrasynovial,  Intramuscular

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

68:04.00   ADRENALS

Anatomical Therapeutic Chemical (ATC): See footnote 4

H02AB02  DEXAMETHASONE

Active ingredient group (AIG) number:See footnote 5

0106305005

List of active ingredient(s)
Active ingredient(s) Strength
DEXAMETHASONE PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) 10 MG / 1 ML

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