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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:

2008-12-04

Original market date: See footnote 1

2008-12-04

Product name:

INFANRIX-HEXA

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:

02253852

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):

11

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

1152394001

List of active ingredient(s)
Active ingredient(s) Strength
DIPHTHERIA TOXOID 25 LF / 0.5 ML
FILAMENTOUS HAEMAGGLUTININ 25 MCG / 0.5 ML
HAEMOPHILUS INFLUENZAE TYPE B-PRP 10 MCG / 0.5 ML
HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCG / 0.5 ML
INACTIVATED POLIOVIRUS TYPE I 40 UNIT / 0.5 ML
INACTIVATED POLIOVIRUS TYPE II 8 UNIT / 0.5 ML
INACTIVATED POLIOVIRUS TYPE III 32 UNIT / 0.5 ML
PERTACTIN 8 MCG / 0.5 ML
PERTUSSIS TOXOID 25 MCG / 0.5 ML
TETANUS TOXOID 10 LF / 0.5 ML
TETANUS TOXOID ADSORBED 40 MCG / 0.5 ML

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