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:

2006-07-27

Original market date: See footnote 1

1999-06-23

Product name:

ADACEL

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:

02240255

Product Monograph/Veterinary Labelling:

Date: 2020-09-25 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):

6

Schedule(s):

Schedule D  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

80:08.00   TOXOIDS

Anatomical Therapeutic Chemical (ATC): See footnote 4

J07AJ52  PERTUSSIS, PURIFIED ANTIGEN, COMB. WITH TOXOIDS

Active ingredient group (AIG) number:See footnote 5

0652741001

List of active ingredient(s)
Active ingredient(s) Strength
DIPHTHERIA TOXOID 2 LF / 0.5 ML
FILAMENTOUS HAEMAGGLUTININ 5 MCG / 0.5 ML
FIMBRIAE TYPES 2 AND 3 (FIM) 5 MCG / 0.5 ML
PERTACTIN 3 MCG / 0.5 ML
PERTUSSIS TOXOID 2.5 MCG / 0.5 ML
TETANUS TOXOID 5 LF / 0.5 ML

Application information

Related information

Contact us

Version 3.8.0
Date modified: