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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:

2015-07-09

Original market date: See footnote 1

2015-07-09

Product name:

DUAKLIR GENUAIR

Description:

FOR ORAL INHALATION. 1 INHALER WITH 30 ACTUATIONS & 1 INHALER WITH 60 ACTUATIONS

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:

02439530

Product Monograph/Veterinary Labelling:

Date: 2018-06-04 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):

Powder (Metered Dose)

Route(s) of administration:

Inhalation

Number of active ingredient(s):

2

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

12:12.08.12   SELECTIVE BETA 2-ADRENERGIC AGONISTS ,  12:08.08   ANTIMUSCARINICS ANTISPASMODICS

Anatomical Therapeutic Chemical (ATC): See footnote 4

R03AL05  FORMOTEROL AND ACLIDINIUM BROMIDE

Active ingredient group (AIG) number:See footnote 5

0256790001

List of active ingredient(s)
Active ingredient(s) Strength
ACLIDINIUM BROMIDE 400 MCG / ACT
FORMOTEROL FUMARATE DIHYDRATE 12 MCG / ACT

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