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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:

2016-07-06

Original market date: See footnote 1

2016-07-06

Product name:

KOVALTRY

Description:

WITH VIAL ADAPTER. SINGLE USE VIAL & 2.5ML PREFILLED DILUENT SYRINGE

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:

02451468

Product Monograph/Veterinary Labelling:

Date: 2019-06-28 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

BAYER INC
2920 Matheson Blvd East
Mississauga
Ontario
Canada  L4W 5R6

Class: 

Human

Dosage form(s):

Kit,  Powder For Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Schedule D  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

20:28.16   HEMOSTATICS

Anatomical Therapeutic Chemical (ATC): See footnote 4

B02BD02  COAGULATION FACTOR VIII

Active ingredient group (AIG) number:See footnote 5

0124180003

List of active ingredient(s)
Active ingredient(s) Strength
ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT / VIAL

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