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:

2022-04-05

Original market date: See footnote 1

2011-06-17

Product name:

ZENHALE

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02361760

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

0252871004

List of active ingredient(s)
Active ingredient(s) Strength
FORMOTEROL FUMARATE DIHYDRATE 5 MCG / ACT
MOMETASONE FUROATE 200 MCG / ACT
Version 4.0.2
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