Product information

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:

2024-01-05

Original market date: ^{See footnote 1}

2021-12-03

Product name:

BREZTRI AEROSPHERE

Description:

PRESSURIZED INHALATION 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:

02518058

Product Monograph/Veterinary Labelling:

Date: 2023-04-14 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):

Schedule(s):

Prescription

American Hospital Formulary Service (AHFS): ^{See footnote 3}

12:12.08.12 , 12:08.08 , 68:04.00

Anatomical Therapeutic Chemical (ATC): ^{See footnote 4}

R03AL11 FORMOTEROL, GLYCOPYRRONIUM BROMIDE AND BUDESONIDE

Active ingredient group (AIG) number:^{See footnote5}

0363070002

List of active ingredient(s)
Active ingredient(s)	Strength
BUDESONIDE	160 MCG / ACT
FORMOTEROL FUMARATE DIHYDRATE	5 MCG / ACT
GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE)	7.2 MCG / ACT

Risk Management Plans ^{See footnote 7}

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

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Footnotes

Footnote 1

The earliest marketed date recorded in the Drug Product Database.

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Footnote 3

The American Hospital Formulary Service permits an easy review of information on a group of drugs with similar activities and uses and allows the reader to determine quickly the similarities and differences among drugs within a group. AHFS® Pharmacologic/Therapeutic Classification© used with permission. © 2022, the American Society of Health-System Pharmacists, Inc. (ASHP). The Data is a part of the AHFS Drug Information®; ASHP is not responsible for the accuracy of transpositions from the original context.

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Footnote 4

The purpose of the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system is to be used as a tool for drug utilization research in order to improve quality of drug use. Drugs are divided into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutical properties.

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Footnote 5

The AIG number is a 10 digit number that identifies products that have the same active ingredient(s) and ingredient strength(s). The AIG is comprised of three portions:

the first portion (2 digits) identifies the number of active ingredients,
the second portion (5 digits) identifies the unique groups of active ingredients(s),
the last portion (3 digits) identifies the active ingredient group strength. The strength group has a tolerance of ‑2% to +10%.

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Footnote 7

Refer to the Health Canada Guidance Documents - "Submission of Risk Management Plans and Follow-up Commitments" as well as "Submission of targeted Risk Management Plans Follow-up Commitments for Prescription Opioid-containing Products" for additional details.

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Date modified:: 2019-03-01