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INDACATEROL & GLYCOPYRRONIUM

All products: Limited Use (codes 459)

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

  • Aclidinium + formoterol (Duaklir Genuair): limited Use 459
  • Budesonide + formoterol + glycopyrronium (Breztri Aerosphere): limited Use 638
  • Fluticasone furoate + umeclidinium + vilanterol (Trelegy Ellipta): limited Use 567
  • 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

Ultibro Breezhaler · DIN 02418282 · 110mcg & 50mcg · Inh Pd-capsule

Limited Use — Reason for Use code 459 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 459 required
Write on scriptLU code 459 (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 459
Reason for Use code 459 For the long-term treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD-see notes below) who have had an inadequate response to a long-acting bronchodilator (i.e., long-acting beta-2 agonist (LABA), or long-acting muscarinic antagonist (LAMA)). Coverage limit: LU Authorization Period: Indefinite Coverage limit: COPD disease severity is based on spirometry, symptoms and disability (see classification tables below). Classification COPD Stages - Symptoms and disability: Mild: Shortness of breath from COPD when hurrying on the level or walking up a slight hill. Moderate: Shortness of breath from COPD causing the patient to stop after walking approximately 100m (or after a few minutes) on the level Severe: Shortness of breath from COPD resulting in the patient being too breathless to leave the house, breathless when dressing or undressing (MRC 5), or the presence of chronic respiratory failure or clinical signs of right heart failure Classification by impairment of lung function: COPD stage and spirometry (post bronchodilator) FEV1 predicted: Mild: Greater than or equal to 80 percent Moderate: 50 to 79 percent Severe: 30 to 49 percent Very severe: Less than 30 percent
No interchangeable product listed in the Ontario extract
Ultibro Breezhaler · DIN 02418282 Manufacturer: Novartis Pharma Canada Inc.; listing date 2015-05-28 Health Canada: Marketed since 2014-03-05 · brand ULTIBRO BREEZHALER · ATC R03AL04 INDACATEROL AND GLYCOPYRRONIUM BROMIDE, R03AL04 INDACATEROL AND GLYCOPYRRONIUM BROMIDE · form Capsule · route Inhalation · ingredients GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE) 50 MCG, INDACATEROL (INDACATEROL MALEATE) 110 MCG · company Novartis pharmaceuticals canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Ultibro Breezhaler: Formulary list price $2.5830/unit (unit not stated in source; not the patient's cost)

Ministry pays: $2.5830 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=90285 · Verify on the e-Formulary ↗ (DIN 02418282)

Source record
DIN 02418282: Ultibro Breezhaler Raw flags: sec12=Y, sec3=Y Item: 121200108; group id 229; item number 0408; lccId 00252; manufacturer id NOV Source form: Inh Pd-Cap; strength: 110mcg & 50mcg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $2.5830; ministry $2.5830 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02418282 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90285
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02418282
Shortage record checked 2026-09-13T08:10:21.292534+00:00
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

BUDESONIDE&GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE)&FORMOTEROL FUMARATE DIHYDRATE

· 1 products · Limited Use, codes 638 · strengths: 160mcg & 7.2mcg & 5mcg/Act · Metered Dose Inh-120 Dose Pk

FLUTICASONE FUROATE & UMECLIDINIUM BROMIDE & VILANTEROL TRIFENATATE

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

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.
Other drugs whose Health Canada label lists a similar indication: obstructive pulmonary disease
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. Covered without a code on the Ontario formulary: ACLIDINIUM BROMIDE, GLYCOPYRRONIUM BROMIDE, TIOTROPIUM BROMIDE MONOHYDRATE, UMECLIDINIUM ACLIDINIUM BROMIDE · General benefit INDICATIONS AND CLINICAL USE TUDORZA GENUAIR (aclidinium bromide) is indicated as a long-term maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. PM: https://pdf.hres.ca/dpd_pm/00067375.PDF; date not captured; DIN 02409720; fetched 2026-09-10 Product monograph ACLIDINIUM BROMIDE & FORMOTEROL FUMARATE DIHYDRATE · Limited Use, codes 459 INDICATIONS AND CLINICAL USE DUAKLIR GENUAIR (aclidinium bromide/formoterol fumarate dihydrate) is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) indicated as a long-term maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. PM: https://pdf.hres.ca/dpd_pm/00067361.PDF; date not captured; DIN 02439530; fetched 2026-09-10 Product monograph FLUTICASONE FUROATE & VILANTEROL · Limited Use, codes 330, 456 (1), Limited Use, codes 330 (1) INDICATIONS AND CLINICAL USE COPD BREO ELLIPTA (fluticasone furoate/vilanterol) 100/25 mcg is a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term once-daily 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. PM: https://pdf.hres.ca/dpd_pm/00049111.PDF; date January 7, 2019; DIN 02408872; fetched 2026-09-10 Product monograph GLYCOPYRRONIUM BROMIDE · General benefit 1 INDICATIONS SEEBRI ® BREEZHALER ® (glycopyrronium bromide) is indicated as a long-term once-daily maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. PM: https://pdf.hres.ca/dpd_pm/00067963.PDF; date October 16, 2012; DIN 02394936; fetched 2026-09-10 Product monograph TIOTROPIUM BROMIDE MONOHYDRATE · General benefit 1 INDICATIONS SPIRIVA (tiotropium bromide monohydrate) is indicated for:  long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. PM: https://pdf.hres.ca/dpd_pm/00065560.PDF; date NOV 20, 2002; DIN 02246793; fetched 2026-09-10 Product monograph TIOTROPIUM BROMIDE MONOHYDRATE & OLODATEROL HYDROCHLORIDE · Limited Use, codes 459 INDICATIONS AND CLINICAL USE INSPIOLTO RESPIMAT (tiotropium bromide monohydrate and olodaterol hydrochloride) is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA) indicated for the long term, once daily maintenance bronchodilator treatment of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema. PM: https://pdf.hres.ca/dpd_pm/00054220.PDF; date November 14, 2019; DIN 02441888; fetched 2026-09-10 Product monograph UMECLIDINIUM · General benefit 1 INDICATIONS INCRUSE ELLIPTA (umeclidinium) is indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. PM: https://pdf.hres.ca/dpd_pm/00072581.PDF; date April 8, 2014; DIN 02423596; fetched 2026-09-10 Product monograph UMECLIDINIUM & VILANTEROL · Limited Use, codes 459 1 INDICATIONS ANORO ELLIPTA (umeclidinium/vilanterol) is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. PM: https://pdf.hres.ca/dpd_pm/00069868.PDF; date March 14, 2014; DIN 02418401; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
1 INDICATIONS ULTIBRO BREEZHALER (indacaterol maleate and glycopyrronium bromide) is a combination of a long- acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for the reduction of exacerbations of COPD in patients with a history of exacerbations. ULTIBRO BREEZHALER is not indicated for the treatment of acute episodes of bronchospasm. ULTIBRO BREEZHALER is not indicated for asthma use. The safety and effectiveness of ULTIBRO BREEZHALER in asthma have not been established. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; 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 over 65 years of age. https://pdf.hres.ca/dpd_pm/00072513.PDF PM date: Dec 23, 2013 Source product: ULTIBRO BREEZHALER; DIN 02418282; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.