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 Pre Market
Current status date:
2018-09-04
Original market date: See footnote 1
Product name:
FENTANYL TRANSDERMAL SYSTEM 100
DIN:
02304155
Product Monograph/Veterinary Labelling:
Date:
2011-06-15
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ACTAVIS GROUP PTC EHF
Reykjavikurvegi 78
Hafnarfjordur
Greater Reykjavik
Iceland
220
Class:
Human
Dosage form(s):
Patch (Extended Release)
Route(s) of administration:
Transdermal
Number of active ingredient(s):
1
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
28:08.08
Anatomical Therapeutic Chemical (ATC): See footnote 4
N02AB03 FENTANYL
Active ingredient group (AIG) number:See footnote5
0123302012
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| FENTANYL | 100 MCG / HOUR |