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:
Dormant
Current status date:
2023-05-18
Original market date: See footnote 1
2013-01-15
Product name:
HYPERHEP B S/D
Description:
ALSO KNOWN AS HEPATITIS B IMMUNE GLOBULIN HUMAN. 0.5ML SYRINGE
DIN:
02379465
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
American Hospital Formulary Service (AHFS): See footnote 3
80:04.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J06BB04 HEPATITIS B IMMUNOGLOBULIN
Active ingredient group (AIG) number:See footnote5
0114080002
| Active ingredient(s) | Strength |
|---|---|
| HEPATITIS B IMMUNOGLOBULIN (HUMAN) | 220 UNIT / ML |