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:
2021-10-26
Original market date: See footnote 1
2012-10-25
Lot number: See footnote 2
AC20B328AC
Expiry date: See footnote 2
2017-09-30
Product name:
INFANRIX-IPV
Description:
PRE-FILLED SYRINGES
DIN:
02241284
Product Monograph/Veterinary Labelling:
Date:
2014-09-11
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):
8
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07CA02 DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS
Active ingredient group (AIG) number:See footnote5
0839081001
| Active ingredient(s) | Strength |
|---|---|
| DIPHTHERIA TOXOID | 30 UNIT / 0.5 ML |
| FILAMENTOUS HAEMAGGLUTININ | 25 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 | 40 UNIT / 0.5 ML |