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BUDESONIDE&GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE)&FORMOTEROL FUMARATE DIHYDRATE

All products: Limited Use (codes 638)

Other products in the same Health Canada class (R03A, R03AL) — coverage varies; not interchangeable

  • Aclidinium + formoterol (Duaklir Genuair): limited Use 459
  • Fluticasone furoate + umeclidinium + vilanterol (Trelegy Ellipta): limited Use 567
  • Glycopyrronium + indacaterol (Ultibro Breezhaler): limited Use 459
  • Umeclidinium + vilanterol (Anoro Ellipta): limited Use 459
  • Salbutamol (Teva-Salbutamol Sterinebs P.F.): general benefit, Limited Use 256, 257, 258, 259, Limited Use 265, 266, 267, 268, Not a benefit
  • Terbutaline (Bricanyl Turbuhaler): general benefit

8 more in the class list below

Breztri Aerosphere · DIN 02518058 · 160mcg & 7.2mcg & 5mcg/Act · Metered Dose inhaler, 120 doses

Limited Use — Reason for Use code 638 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 638 required
Write on scriptLU code 638 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 638
Reason for Use code 638 For the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations in patients who require a combination of an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA). Coverage limit: LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Breztri Aerosphere · DIN 02518058 Manufacturer: AstraZeneca; listing date 2022-10-31 Health Canada: Marketed since 2024-01-05 · brand BREZTRI AEROSPHERE · ATC R03AL11 FORMOTEROL, GLYCOPYRRONIUM BROMIDE AND BUDESONIDE · form Aerosol (metered-dose) · route Inhalation · ingredients BUDESONIDE 160 MCG/ACT, GLYCOPYRRONIUM (GLYCOPYRROLATE) 7.2 MCG/ACT, FORMOTEROL FUMARATE DIHYDRATE 5 MCG/ACT · company Astrazeneca canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Breztri Aerosphere: Formulary list price $127.0000/unit (unit not stated in source; not the patient's cost)

Ministry pays: $127.0000 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100738 · Verify on the e-Formulary ↗ (DIN 02518058)

Source record
DIN 02518058: Breztri Aerosphere Raw flags: sec12=Y, sec3=Y Item: 121200121; group id 221; item number 0399; lccId 00385; manufacturer id AZC Source form: Metered Dose Inh-120 Dose Pk; strength: 160mcg & 7.2mcg & 5mcg/Act Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $127.0000; ministry $127.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02518058 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100738
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (12:12 Sympathomimetic (Adrenergic) Agents) and how they are covered

Matched class: 12:12 Sympathomimetic (Adrenergic) Agents

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: EPINEPHRINE HCL, TERBUTALINE SULFATE Some products covered without a code (check the product listing): ORCIPRENALINE SULFATE, SALBUTAMOL 12:12 Sympathomimetic (Adrenergic) Agents

ACLIDINIUM BROMIDE & FORMOTEROL FUMARATE DIHYDRATE

· 1 products · Limited Use, codes 459 · strengths: 400mcg & 12mcg · Metered Dose Pd Inh-60 Dose Pk

FLUTICASONE FUROATE & UMECLIDINIUM BROMIDE & VILANTEROL TRIFENATATE

· 1 products · Limited Use, codes 567 · strengths: 100mcg & 62.5mcg & 25mcg · Pd Inh-30 Dose Pk

INDACATEROL & GLYCOPYRRONIUM

· 1 products · Limited Use, codes 459 · strengths: 110mcg & 50mcg · Inh Pd-Cap

UMECLIDINIUM & VILANTEROL

· 1 products · Limited Use, codes 459 · strengths: 62.5mcg & 25mcg · Blister Pd Inh-30 Dose Pk

SALBUTAMOL

· 20 products · Limited Use, codes 265, 266, 267, 268 (4), Listed, not a benefit (8), Limited Use, codes 256, 257, 258, 259 (1), General benefit (7) · strengths: 1mg/mL, 2mg/mL, 5mg/mL, 100mcg/Metered Dose, 2mg, 4mg · Inh Sol- 2.5mL Pk, Inh Sol-10mL Pk, Inh-200 dose Pk, Tab

TERBUTALINE SULFATE

· 2 products · General benefit · strengths: 0.5mg/Dose · Inh-100 Dose Pk, Inh-120 Dose Pk

BUDESONIDE & FORMOTEROL FUMARATE DIHYDRATE

· 2 products · Limited Use, codes 330 · strengths: 100mcg/6mcg, 200mcg/6mcg · Pd Inh-120 Dose Pk

FLUTICASONE FUROATE & VILANTEROL

· 2 products · Limited Use, codes 330, 456 (1), Limited Use, codes 330 (1) · strengths: 100mcg & 25mcg, 200mcg & 25mcg · Blister Pd Inh-30 Dose Pk

FORMOTEROL FUMARATE

· 1 products · Limited Use, codes 132 · strengths: 12mcg/Cap · Inh Pd-Device Pk

FORMOTEROL FUMARATE DIHYDRATE

· 2 products · Limited Use, codes 132 · strengths: 6mcg/Metered Dose, 12mcg/Metered Dose · Pd Inh-60 Dose Pk

INDACATEROL

· 1 products · Limited Use, codes 443 · strengths: 75mcg · Inh Pd-Cap

MOMETASONE FUROATE & FORMOTEROL FUMARATE DIHYDRATE

· 2 products · Limited Use, codes 330 · strengths: 100mcg & 5mcg, 200mcg & 5mcg · Metered Dose Inh-120 Dose Pk Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 12:12 and 4 more
Full class listing Related classes: 12:04 Parasympathomimetic (Cholinergic) Agents, 12:08 Parasympatholytic (Cholinergic Blocking) Agents, 12:20 Skeletal Muscle Relaxants Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1 INDICATIONS BREZTRI™ AEROSPHERE® (budesonide/glycopyrronium/formoterol fumarate dihydrate) is a combination of an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term maintenance treatment to reduce exacerbations of chronic obstructive pulmonary disease (COPD) and treat airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema who are not adequately treated by a combination of an ICS/LABA or a combination of a LAMA/LABA. BREZTRI AEROSPHERE is not indicated for the treatment of acute episodes of bronchospasm (see General). BREZTRI AEROSPHERE is not indicated for the treatment of asthma. 1.1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of BREZTRI AEROSPHERE in pediatric patients under 18 years of age have not been established; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics (≥ 65 years of age): No dosage adjustment is required in patients 65 years of age and older. https://pdf.hres.ca/dpd_pm/00074118.PDF PM date: APR 14, 2023 Source product: BREZTRI AEROSPHERE; DIN 02518058; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.