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:
2016-11-11
Original market date: See footnote 1
2016-11-11
Product name:
ENSTILAR
DIN:
02457393
Product Monograph/Veterinary Labelling:
Date:
2022-05-12
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
LEO PHARMA INC
6 Adelaide Street East, Suite 200
Toronto
Ontario
Canada
M5C 1H6
Class:
Human
Dosage form(s):
Aerosol, Foam
Route(s) of administration:
Topical
Number of active ingredient(s):
2
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
84:06.00 , 84:92.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
D05AX52 CALCIPOTRIOL, COMBINATIONS
Active ingredient group (AIG) number:See footnote5
0252270002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| BETAMETHASONE (BETAMETHASONE DIPROPIONATE) | 0.5 MG / G |
| CALCIPOTRIOL (CALCIPOTRIOL MONOHYDRATE) | 50 MCG / G |