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:
Approved
Current status date:
2025-07-15
Product name:
APO-METHYLPHENIDATE CR
DIN:
02559404
Product Monograph/Veterinary Labelling:
Date:
2025-07-15
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
APOTEX INC
150 Signet Drive
Toronto
Ontario
Canada
M9L 1T9
Class:
Human
Dosage form(s):
Capsule (Extended-Release)
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
CONTROLLED DRUGS (CDSA III)
Anatomical Therapeutic Chemical (ATC): See footnote 4
N06BA04 METHYLPHENIDATE
Active ingredient group (AIG) number:See footnote5
0107548001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | 10 MG |