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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:

2013-02-13

Original market date: See footnote 1

1997-07-08

Product name:

HYPERHEP B S/D

Description:

ALSO KNOWN AS HEPATITIS B IMMUNE GLOBULIN HUMAN. 5ML VIAL

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:

02230738

Product Monograph/Veterinary Labelling:

Date: 2012-02-02 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

GRIFOLS THERAPEUTICS LLC
8368 Us 70 Business Hwy. West
Clayton
North Carolina
United States  27520-9464

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intramuscular

Number of active ingredient(s):

1

Schedule(s):

Schedule D  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

80:04.00   SERUMS

Anatomical Therapeutic Chemical (ATC): See footnote 4

J06BB04  HEPATITIS B IMMUNOGLOBULIN

Active ingredient group (AIG) number:See footnote 5

0114080002

List of active ingredient(s)
Active ingredient(s) Strength
HEPATITIS B IMMUNOGLOBULIN (HUMAN) 220 UNIT / ML

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