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:
2012-10-25
Original market date: See footnote 1
2010-03-01
Product name:
PREVNAR 13
DIN:
02335204
Product Monograph/Veterinary Labelling:
Date:
2019-08-08
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):
Suspension
Route(s) of administration:
Intramuscular
Number of active ingredient(s):
14
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07AL02 PNEUMOCOCCUS, PURIFIED POLYSACC.ANTIGEN CONJUGATED
Active ingredient group (AIG) number:See footnote5
1453550001
| Active ingredient(s) | Strength |
|---|---|
| CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN | 34 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 | 2.2 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 | 2.2 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C | 2.2 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A | 2.2 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F | 2.2 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F | 2.2 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 | 2.2 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 | 2.2 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 | 2.2 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A | 2.2 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B | 4.4 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F | 2.2 MCG / 0.5 ML |
| PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V | 2.2 MCG / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.