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:

Cancelled Post Market

Current status date:

2018-05-17

Original market date: See footnote 1

2014-03-28

Lot number: See footnote 2

9970515

Expiry date: See footnote 2

2016-11-30

Product name:

DOCETAXEL INJECTION

Description:

SINGLE DOSE VIAL. CONCENTRATE. 28MG/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:

02412233

Product Monograph/Veterinary Labelling:

Date: 2017-09-06 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

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

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous

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

L01CD02 DOCETAXEL

Active ingredient group (AIG) number:See footnote5

0127884003

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
DOCETAXEL 80 MG / 2.88 ML
Version 4.0.3

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