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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:

2021-04-07

Original market date: See footnote 1

2021-04-07

Product name:

PNEUMOVAX 23

Description:

SINGLE-DOSE PREFILLED SYRINGE

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:

02436442

Product Monograph/Veterinary Labelling:

Date: 2016-07-27 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

MERCK CANADA INC
16750 Route Transcanadienne
Kirkland
Quebec
Canada  H9H 4M7

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intramuscular,  Subcutaneous

Number of active ingredient(s):

23

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

J07AL02  PNEUMOCOCCUS, PURIFIED POLYSACC.ANTIGEN CONJUGATED

Active ingredient group (AIG) number:See footnote 5

2352867001

List of active ingredient(s)
Active ingredient(s) Strength
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N 25 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 25 MCG / 0.5 ML

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