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:

2018-04-24

Original market date: See footnote 1

2018-04-24

Product name:

RITUXAN SC

Description:

SINGLE DOSE VIAL - 120 MG/ML

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DIN:

02473976

Product Monograph/Veterinary Labelling:

Date: 2020-11-19 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

HOFFMANN-LA ROCHE LIMITED
7070 Mississauga Road
Mississauga
Ontario
Canada L5N 5M8

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

10:00.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

L01FA01 RITUXIMAB

Active ingredient group (AIG) number:See footnote5

0140241002

List of active ingredient(s)
Active ingredient(s) Strength
RITUXIMAB 1600 MG / 13.4 ML

Risk Management Plans See footnote 7

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

Additional Risk Minimization Measures
Healthcare Professional Education
Patient Wallet Card
Pharmacovigilance/Monitoring Activity
Observational Studies
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