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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

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02402904

Product Monograph/Veterinary Labelling:

Date: 2021-08-23 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  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

80:12.00   VACCINES

Anatomical Therapeutic Chemical (ATC): See footnote 4

J07AH04  Meningococcus, A, C, Y, W-135, Tetraval. purified polysacc. antigen

Active ingredient group (AIG) number:See footnote 5

0554131001

List of active ingredient(s)
Active ingredient(s) 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

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