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:
Marketed
Current status date:
2024-05-30
Original market date: See footnote 1
2014-08-07
Product name:
APTIOM
DIN:
02426862
Product Monograph/Veterinary Labelling:
Date:
2024-01-25
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SUMITOMO PHARMA CANADA, INC.
301
7025 Langer Drive
Mississauga
Ontario
Canada
L5N 0E8
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
28:12.92
Anatomical Therapeutic Chemical (ATC): See footnote 4
N03AF04 ESLICARBAZEPINE
Active ingredient group (AIG) number:See footnote5
0155850001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ESLICARBAZEPINE ACETATE | 200 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.