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:
Cancelled Post Market
Current status date:
2016-12-06
Original market date: See footnote 1
1998-01-20
Product name:
ULTRESA
DIN:
02045834
Product Monograph/Veterinary Labelling:
Date:
2015-06-05
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
APTALIS PHARMA CANADA ULC
1380 Roddick Road, Suite 300
Markham
Ontario
Canada
L3R 4G5
Class:
Human
Dosage form(s):
Capsule (Delayed Release)
Route(s) of administration:
Oral
Number of active ingredient(s):
3
Schedule(s):
Schedule D , Prescription
American Hospital Formulary Service (AHFS): See footnote 3
56:16.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
A09AA02 MULTIENZYMES (LIPASE, PROTEASE ETC)
Active ingredient group (AIG) number:See footnote5
0302964034
| Active ingredient(s) | Strength |
|---|---|
| AMYLASE | 58800 UNIT |
| LIPASE | 13800 UNIT |
| PROTEASE | 53400 UNIT |