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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:

2018-04-09

Original market date: See footnote 1

2012-09-12

Product name:

TREANDA

Description:

SINGLE-USE VIAL. I.V INFUSION ONLY.

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:

02392550

Product Monograph/Veterinary Labelling:

Date: 2018-01-10 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

TEVA CANADA LIMITED
30 Novopharm Court
Toronto
Ontario
Canada  M1B 2K9

Class: 

Human

Dosage form(s):

Powder For Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

10:00.00   ANTINEOPLASTIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

L01AA09  BENDAMUSTINE

Active ingredient group (AIG) number:See footnote 5

0153268001

List of active ingredient(s)
Active ingredient(s) Strength
BENDAMUSTINE HYDROCHLORIDE 25 MG / VIAL

Risk Management Plans See footnote 7

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

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