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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:

2010-10-22

Original market date: See footnote 1

2010-10-22

Product name:

BOOSTRIX-POLIO

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:

02312557

Product Monograph/Veterinary Labelling:

Date: 2021-08-05 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

GLAXOSMITHKLINE INC
7333 Mississauga Road
Mississauga
Ontario
Canada  L5N 6L4

Class: 

Human

Dosage form(s):

Suspension

Route(s) of administration:

Intramuscular

Number of active ingredient(s):

8

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

J07CA02  DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS

Active ingredient group (AIG) number:See footnote 5

0852468001

List of active ingredient(s)
Active ingredient(s) Strength
DIPHTHERIA TOXOID ADSORBED 2.5 LF / 0.5 ML
FILAMENTOUS HAEMAGGLUTININ ADSORBED 8 MCG / 0.5 ML
INACTIVATED POLIOVIRUS TYPE I 40 D / 0.5 ML
INACTIVATED POLIOVIRUS TYPE II 8 D / 0.5 ML
INACTIVATED POLIOVIRUS TYPE III 32 D / 0.5 ML
PERTACTIN ADSORBED 2.5 MCG / 0.5 ML
PERTUSSIS TOXOID ADSORBED 8 MCG / 0.5 ML
TETANUS TOXOID ADSORBED 5.0 LF / 0.5 ML

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