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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:

2018-09-28

Original market date: See footnote 1

2015-08-27

Product name:

MOVANTIK

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:

02442167

Product Monograph/Veterinary Labelling:

Date: 2019-12-11 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

KNIGHT THERAPEUTICS INC.
1055  3400 De Maisonneuve Blvd W
Montreal
Quebec
Canada  H3Z 3B8

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

56:92.00   MISCELLANEOUS GI DRUGS

Anatomical Therapeutic Chemical (ATC): See footnote 4

A06AH03  NALOXEGOL

Active ingredient group (AIG) number:See footnote 5

0157010001

List of active ingredient(s)
Active ingredient(s) Strength
NALOXEGOL (NALOXEGOL OXALATE) 12.5 MG

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

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