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:

Marketed

Current status date:

2006-02-07

Original market date: See footnote 1

2001-04-11

Product name:

RECOMBIVAX HB

Description:

PRESERVATIVE-FREE

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:

02243676

Product Monograph/Veterinary Labelling:

Date: 2012-05-22 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

MERCK CANADA INC
16750 Route Transcanadienne
Kirkland
Quebec
Canada H9H 4M7

Class:

Human

Dosage form(s):

Suspension

Route(s) of administration:

Intramuscular

Number of active ingredient(s):

1

Schedule(s):

Schedule D

 

American Hospital Formulary Service (AHFS): See footnote 3

80:12.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

J07BC01 HEPATITIS B, PURIFIED ANTIGEN

Active ingredient group (AIG) number:See footnote5

0119570001

List of active ingredient(s)
Active ingredient(s) Strength
HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCG / ML
Version 4.0.2
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