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:
Marketed
Current status date:
2017-05-17
Original market date: See footnote 1
2013-08-22
Product name:
NIMENRIX
Description:
SINGLE-DOSE VIAL WITH DILUENT (0.5ML IN A PREFILLED-SYRINGE). 1 & 10 KITS
DIN:
02402904
Product Monograph/Veterinary Labelling:
Date:
2023-11-28
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
PFIZER CANADA ULC
17300 Trans-Canada Highway
Kirkland
Quebec
Canada
H9J 2M5
Class:
Human
Dosage form(s):
Powder For Solution , Kit
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
J07AH04 MENINGOCOCCUS, A, C, Y, W-135, TETRAVAL. PURIFIED POLYSACC. ANTIGEN
Active ingredient group (AIG) number:See footnote5
0554131001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP A | 5 MCG / 0.5 ML |
| MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP C | 5 MCG / 0.5 ML |
| MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP W-135 | 5 MCG / 0.5 ML |
| MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP Y | 5 MCG / 0.5 ML |
| TETANUS TOXOID | 44 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 |