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:

Cancelled Post Market

Current status date:

2017-08-02

Original market date: See footnote 1

2001-06-20

Lot number: See footnote 2

E52445

Expiry date: See footnote 2

2014-02-28

Product name:

PREVNAR

Description:

SINGLE DOSE PRE-FILLED SYRINGES AND VIALS

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:

02244081

Product Monograph/Veterinary Labelling:

Date: 2010-10-07 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):

8

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

0844301002

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 20 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 2 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 2 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F 2 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 2 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 2 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 4 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 2 MCG / 0.5 ML
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