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:
Approved
Current status date:
2022-12-06
Product name:
PREHEVBRIO
DIN:
02533286
Product Monograph/Veterinary Labelling:
Date:
2022-12-06
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
VBI VACCINES INC.
310 Hunt Club Road
Ottawa
Ontario
Canada
K1V 1C1
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
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) | 10 MCG / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Registry |