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 Pre Market

Current status date:

2023-05-11

Original market date: See footnote 1

Product name:

NAT-AZACITIDINE

Description:

SINGLE USE VIALS

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:

02480220

Product Monograph/Veterinary Labelling:

Date: 2023-01-16 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

NATCO PHARMA (CANADA) INC
2000 Argentia Road, Plaza 1, Suite 200
Mississauga
Ontario
Canada L5N 1P7

Class:

Human

Dosage form(s):

Powder For Suspension

Route(s) of administration:

Subcutaneous

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

L01BC07 AZACITIDINE

Active ingredient group (AIG) number:See footnote5

0152665001

List of active ingredient(s)
Active ingredient(s) Strength
AZACITIDINE 100 MG / VIAL
Version 4.0.2
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