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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:

2007-10-04

Original market date: See footnote 1

2007-10-04

Product name:

PEDIACEL

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:

02243167

Product Monograph/Veterinary Labelling:

Date: 2012-02-28 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

SANOFI PASTEUR LIMITED
1755 Steeles Avenue West
Toronto
Ontario
Canada  M2R 3T4

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

J07CA06  DIPHT-HEMOPH INFLUEN B-PERTUSS-POLIO-TETANUS

Active ingredient group (AIG) number:See footnote 5

1162215001

List of active ingredient(s)
Active ingredient(s) Strength
DIPHTHERIA TOXOID 15 LF / 0.5 ML
FILAMENTOUS HAEMAGGLUTININ 20 MCG / 0.5 ML
FIMBRIAE 5 MCG / 0.5 ML
HAEMOPHILUS INFLUENZAE TYPE B-PRP 10 MCG / 0.5 ML
INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 1 MAHONEY 40 UNIT / 0.5 ML
INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 2 MEF1 8 UNIT / 0.5 ML
INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 3 SAUKETT 32 UNIT / 0.5 ML
PERTACTIN 3 MCG / 0.5 ML
PERTUSSIS TOXOID 20 MCG / 0.5 ML
TETANUS PROTEIN 30 MCG / 0.5 ML
TETANUS TOXOID 5 LF / 0.5 ML

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