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:
2015-10-02
Original market date: See footnote 1
2015-10-02
Product name:
BREO ELLIPTA
DIN:
02444186
Product Monograph/Veterinary Labelling:
Date:
2019-01-07
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GLAXOSMITHKLINE INC
800
100 Milverton Drive
Mississauga
Ontario
Canada
L5R 4H1
Class:
Human
Dosage form(s):
Powder
Route(s) of administration:
Inhalation
Number of active ingredient(s):
2
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
68:04.00 , 12:12.08.12
Anatomical Therapeutic Chemical (ATC): See footnote 4
R03AK10 VILANTEROL AND FLUTICASONE FUROATE
Active ingredient group (AIG) number:See footnote5
0254450004
| Active ingredient(s) | Strength |
|---|---|
| FLUTICASONE FUROATE | 200 MCG / ACT |
| VILANTEROL (VILANTEROL TRIFENATATE) | 25 MCG / ACT |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.