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:

Marketed

Current status date:

2013-06-07

Original market date: See footnote 1

2013-06-07

Product name:

XTANDI

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:

02407329

Product Monograph/Veterinary Labelling:

Date: 2024-01-05 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

ASTELLAS PHARMA CANADA INC
650 675 Cochrane Drive, West Tower
Markham
Ontario
Canada L3R 0B8

Class:

Human

Dosage form(s):

Capsule

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

10:00.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

L02BB04 ENZALUTAMIDE

Active ingredient group (AIG) number:See footnote5

0154350001

List of active ingredient(s)
Active ingredient(s) Strength
ENZALUTAMIDE 40 MG

Risk Management Plans See footnote 7

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

Version 4.0.2
Date modified: