Product information
From Health Canada
No match found
No other product was found with the same active ingredient group.
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:
2024-01-17
Original market date: See footnote 1
2022-10-03
Product name:
SUPEMTEK
Description:
PREFILLED SYRINGE
DIN:
02510936
Product Monograph/Veterinary Labelling:
Date:
2022-05-10
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SANOFI PASTEUR LIMITED
1755 Steeles Avenue West
Toronto
Ontario
Canada
M2R 3T4
Class:
Human
Dosage form(s):
Solution
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
0462721001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| RECOMBINANT HAEMAGGLUTININ PROTEIN-STRAIN A (H1N1) | 45 MCG / 0.5 ML |
| RECOMBINANT HAEMAGGLUTININ PROTEIN-STRAIN A (H3N2) | 45 MCG / 0.5 ML |
| RECOMBINANT HAEMAGGLUTININ PROTEIN-STRAIN B (VICTORIA) | 45 MCG / 0.5 ML |
| RECOMBINANT HAEMAGGLUTININ PROTEIN-STRAIN B (YAMAGATA) | 45 MCG / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |