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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:

2019-12-11

Original market date: See footnote 1

2019-12-11

Product name:

TRUXIMA

Description:

SINGLE-DOSE VIAL - 10 MG/ML

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:

02478382

Product Monograph/Veterinary Labelling:

Date: 2020-05-22 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

CELLTRION HEALTHCARE CO LTD
19 Academy-Ro 51 Beon-Gil
Yeonsu-Gu, Incheon
--
Korea, Republic Of  22014

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription,  Schedule D  

Biosimilar Biologic Drug:

Yes

American Hospital Formulary Service (AHFS): See footnote 3

10:00.00   ANTINEOPLASTIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

L01XC02  RITUXIMAB

Active ingredient group (AIG) number:See footnote 5

0140241001

List of active ingredient(s)
Active ingredient(s) Strength
RITUXIMAB 100 MG / 10 ML

Application information

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