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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:

2014-03-21

Original market date: See footnote 1

2014-03-21

Product name:

FONDAPARINUX SODIUM INJECTION

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:

02406853

Product Monograph/Veterinary Labelling:

Date: 2019-09-04 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

DR REDDY'S LABORATORIES LTD
Survey Nos 42,45,46,54 Bachupally, Quthbullapur
Hyderabad
Telangana
India  500090

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous,  Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

20:12.04.14   Direct Factor Xa Inhibitors

Anatomical Therapeutic Chemical (ATC): See footnote 4

B01AX05  FONDAPARINUX

Active ingredient group (AIG) number:See footnote 5

0146781001

List of active ingredient(s)
Active ingredient(s) Strength
FONDAPARINUX SODIUM 2.5 MG / 0.5 ML

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