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:

Approved

Current status date:

2022-02-16

Product name:

GLYCOPYRRONIUM / FORMOTEROL FUMARATE DIHYDRATE PRESSURIZED INHALATION SUSPENSION

Description:

SUSPENSION

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:

02473615

Product Monograph/Veterinary Labelling:

Date: 2022-02-11 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

ASTRAZENECA CANADA INC
1004 Middlegate Road, Suite 5000
Mississauga
Ontario
Canada L4Y 1M4

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

12:08.08  ,  12:12.08.12 

Anatomical Therapeutic Chemical (ATC): See footnote 4

R03AL07 FORMOTEROL AND GLYCOPYRRONIUM BROMIDE

Active ingredient group (AIG) number:See footnote5

0260050001

List of active ingredient(s)
Active ingredient(s) Strength
FORMOTEROL FUMARATE DIHYDRATE 5.8 MCG / ACT
GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE) 8.3 MCG / ACT
Version 4.0.2
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