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:
2022-02-22
Original market date: See footnote 1
2011-03-10
Product name:
ZENHALE
Description:
SUSPENSION
DIN:
02361752
Product Monograph/Veterinary Labelling:
Date:
2021-04-23
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ORGANON CANADA INC.
300
16766 Route Transcanadienne
Kirkland
Quebec
Canada
H9H 4M7
Class:
Human
Dosage form(s):
Aerosol, Metered Dose
Route(s) of administration:
Inhalation
Number of active ingredient(s):
2
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
48:10.08.08 , 12:12.08.12
Anatomical Therapeutic Chemical (ATC): See footnote 4
R03AK09 FORMOTEROL AND MOMETASONE
Active ingredient group (AIG) number:See footnote5
0252871005
| Active ingredient(s) | Strength |
|---|---|
| FORMOTEROL FUMARATE DIHYDRATE | 5 MCG / ACT |
| MOMETASONE FUROATE | 100 MCG / ACT |