Product information

From Health Canada

New search

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:

2018-04-23

Original market date: See footnote 1

2009-05-22

Product name:

SYNFLORIX

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:

02320541

Product Monograph/Veterinary Labelling:

Date: 2019-11-13 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):

10

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

1052505001

List of active ingredient(s)
Active ingredient(s) Strength
PNEUMOCOCCAL POLYSACC. SEROT. 18C CONJUG. TO TETANUS TOXOID CARRIER PROT. 3 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARID SEROT. 19F CONJUG. TO DIPHTHERIA TOXOID CARRIER PROT. 3 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN D CARRIER PROTEIN 1 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO PROTEIN D CARRIER PROTEIN 1 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO PROTEIN D CARRIER PROTEIN 1 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D CARRIER PROTEIN 3 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D CARRIER PROTEIN 1 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO PROTEIN D CARRIER PROTEIN 1 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO PROTEIN D CARRIER PROTEIN 1 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO PROTEIN D CARRIER PROTEIN 1 MCG / 0.5 ML

Application information

Related information

Contact us

Version 3.8.0
Date modified: