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:
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
DIN:
02418282
Product Monograph/Veterinary Labelling:
Date:
2023-09-14
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
NOVARTIS PHARMACEUTICALS CANADA INC
100
700 Rue Saint-Hubert
Montreal
Quebec
Canada
H2Y 0C1
Class:
Human
Dosage form(s):
Capsule
Route(s) of administration:
Inhalation
Number of active ingredient(s):
2
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
12:12.08.12 , 12:08.08
Anatomical Therapeutic Chemical (ATC): See footnote 4
R03AL04 INDACATEROL AND GLYCOPYRRONIUM BROMIDE
Active ingredient group (AIG) number:See footnote5
0255131001
| Active ingredient(s) See footnote8 | 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.