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:
2013-02-13
Product name:
AREPANRIX H5N1
Description:
AS03-ADJUVANTED QUEBEC H5N1 INFLUENZA VACCINE
DIN:
02401886
Product Monograph/Veterinary Labelling:
Date:
2017-01-31
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ID BIOMEDICAL CORPORATION OF QUEBEC
2323 Boul Parc Technologique
Quebec
Quebec
Canada
G1P 4R8
Class:
Human
Dosage form(s):
Emulsion
Route(s) of administration:
Intramuscular
Number of active ingredient(s):
4
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07BB02 INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN
Active ingredient group (AIG) number:See footnote5
0453693001
| Active ingredient(s) | Strength |
|---|---|
| HAEMAGGLUTININ-STRAIN A (H5N1) | 3.75 MCG / 0.5 ML |
| POLYSORBATE 80 | 4.86 MG / 0.5 ML |
| SQUALENE | 10.69 MG / 0.5 ML |
| VITAMIN E (DL-ALPHA TOCOPHEROL) | 11.86 MG / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Registry |
| Observational Studies |