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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:

2014-03-05

Original market date: See footnote 1

2014-03-05

Product name:

ULTIBRO BREEZHALER

Description:

CAPSULE TO BE USED ONLY WITH ULTIBRO BREEZHALER DEVICE - ORAL INHALATION

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:

02418282

Product Monograph/Veterinary Labelling:

Date: 2020-01-27 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

NOVARTIS PHARMACEUTICALS CANADA INC
385 Bouchard Blvd
Dorval
Quebec
Canada  H9S 1A9

Class: 

Human

Dosage form(s):

Capsule

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

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

Anatomical Therapeutic Chemical (ATC): See footnote 4

R03AL04  INDACATEROL AND GLYCOPYRRONIUM BROMIDE

Active ingredient group (AIG) number:See footnote 5

0255131001

List of active ingredient(s)
Active ingredient(s) Strength
GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE) 50 MCG
INDACATEROL (INDACATEROL MALEATE) 110 MCG

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

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