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:
2020-10-29
Product name:
MENQUADFI
Description:
SINGLE DOSE VIAL
DIN:
02507161
Product Monograph/Veterinary Labelling:
Date:
2024-08-21
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):
5
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07AH08 MENINGOCOCCUS, A, C, Y, W-135, TETRAVAL. PURIFIED POLYSACC. ANTIGEN CONJUGATED
Active ingredient group (AIG) number:See footnote5
0562558001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| MENINGOCOCCAL GROUP A POLYSACCHARIDE-TETANUS TOXOID CONJUGATE | 10 MCG / 0.5 ML |
| MENINGOCOCCAL GROUP C POLYSACCHARIDE-TETANUS TOXOID CONJUGATE | 10 MCG / 0.5 ML |
| MENINGOCOCCAL GROUP W POLYSACCHARIDE-TETANUS TOXOID CONJUGATE | 10 MCG / 0.5 ML |
| MENINGOCOCCAL GROUP Y POLYSACCHARIDE-TETANUS TOXOID CONJUGATE | 10 MCG / 0.5 ML |
| TETANUS TOXOID | 55 MCG / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.