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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:

2017-05-30

Original market date: See footnote 1

2017-05-30

Product name:

NALTREXONE HYDROCHLORIDE TABLETS USP

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:

02451883

Product Monograph/Veterinary Labelling:

Date: 2016-02-05 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

STERINOVA INC.
3005 Avenue Jose-Maria Rosell
Saint-Hyacinthe
Quebec
Canada  J2S 0J9

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:10.00   OPIATE ANTAGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N07BB04  NALTREXONE

Active ingredient group (AIG) number:See footnote 5

0118591001

List of active ingredient(s)
Active ingredient(s) Strength
NALTREXONE HYDROCHLORIDE 50 MG

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