Product information

From Health Canada

New search

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:

Approved

Current status date:

2021-01-22

Product name:

KESIMPTA

Description:

PRE-FILLED SYRINGE

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:

02511363

Product Monograph/Veterinary Labelling:

Date: 2021-01-22 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

NOVARTIS PHARMACEUTICALS CANADA INC
385 Bouchard Blvd
Dorval
Quebec
Canada  H9S 1A9

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Prescription,  Schedule D  

American Hospital Formulary Service (AHFS): See footnote 3

92:20.00   Immunomodulatory Agents

Anatomical Therapeutic Chemical (ATC): See footnote 4

L01XC10  OFATUMUMAB

Active ingredient group (AIG) number:See footnote 5

0153129002

List of active ingredient(s)
Active ingredient(s) Strength
OFATUMUMAB 20 MG / 0.4 ML

Application information

Related information

Contact us

Version 3.9.1
Date modified: