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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:

2020-09-25

Original market date: See footnote 1

2016-01-15

Product name:

ELOCTATE

Description:

SINGLE-USE VIAL (POWDER), PRE-FILLED SYRINGE (DILUENT)

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:

02430290

Product Monograph/Veterinary Labelling:

Date: 2020-09-25 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

SANOFI-AVENTIS CANADA INC
2905 Place Louis-R. Renaud
Laval
Quebec
Canada  H7V 0A3

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

0155970001

List of active ingredient(s)
Active ingredient(s) Strength
ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 250 UNIT / VIAL

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