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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:

2003-07-23

Original market date: See footnote 1

2003-07-23

Product name:

CONCERTA

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:

02247733

Product Monograph/Veterinary Labelling:

Date: 2019-04-17 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

JANSSEN INC
19 Green Belt Drive
Toronto
Ontario
Canada  M3C 1L9

Class: 

Human

Dosage form(s):

Tablet (Extended-Release)

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Schedule G (CDSA III)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:20.32   Respiratory and CNS Stimulants

Anatomical Therapeutic Chemical (ATC): See footnote 4

N06BA04  METHYLPHENIDATE

Active ingredient group (AIG) number:See footnote 5

0107548005

List of active ingredient(s)
Active ingredient(s) Strength
METHYLPHENIDATE HYDROCHLORIDE 36 MG

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