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:
2018-04-23
Original market date: See footnote 1
2009-05-22
Product name:
SYNFLORIX
DIN:
02320541
Product Monograph/Veterinary Labelling:
Date:
2023-11-09
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GLAXOSMITHKLINE INC
800
100 Milverton Drive
Mississauga
Ontario
Canada
L5R 4H1
Class:
Human
Dosage form(s):
Suspension
Route(s) of administration:
Intramuscular
Number of active ingredient(s):
10
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
1052505001
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 |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
Pharmacovigilance/Monitoring Activity |
---|
Clinical Trials |