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MOMETASONE FUROATE & FORMOTEROL FUMARATE DIHYDRATE

All strengths: Limited Use — Reason for Use code 330 required; same patient cost rules

Shared coverage and patient cost rules

StatusLimited Use — Reason for Use code 330 required

Patient paysPatient pays: program not supplied; amount cannot be determined.

Other products in the same Health Canada class (R03A, R03AK) — coverage varies; not interchangeable

Budesonide + formoterol (Symbicort 100 Turbuhaler): limited Use 330
Fluticasone furoate + vilanterol (Breo Ellipta): limited Use 330, Limited Use 330, 456
Fluticasone + salmeterol (Advair 125): limited Use 330
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
Aclidinium + formoterol (Duaklir Genuair): limited Use 459

8 more in the class list below

Zenhale · DIN 02361752 · 100mcg & 5mcg · Metered Dose inhaler, 120 doses

Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02

Write on scriptLU code 330 (patient must meet the criteria below)

Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ontario Limited Use criteria — code 330

Reason for Use code 330 For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms. Coverage limit: LU Authorization Period: Indefinite

No interchangeable product listed in the Ontario extract

Zenhale · DIN 02361752 Manufacturer: Organon Canada Inc.; listing date 2012-02-29 Health Canada: Marketed since 2022-02-22 · brand ZENHALE · ATC R03AK09 FORMOTEROL AND MOMETASONE, R03AK09 FORMOTEROL AND MOMETASONE · form Aerosol (metered-dose) · route Inhalation · ingredients MOMETASONE FUROATE 100 MCG/ACT, FORMOTEROL FUMARATE DIHYDRATE 5 MCG/ACT · company Organon canada inc. · schedule Prescription

Check this DIN again · Health Canada product record

Zenhale: Formulary list price $129.8900/unit (unit not stated in source; not the patient's cost)

Ministry pays: $129.8900 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=84680 · Verify on the e-Formulary ↗ (DIN 02361752)

Source record

DIN 02361752: Zenhale Raw flags: sec12=Y, sec3=Y Item: 121200095; group id 230; item number 0409; lccId 00220; manufacturer id OCI Source form: Metered Dose Inh-120 Dose Pk; strength: 100mcg & 5mcg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $129.8900; ministry $129.8900 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02361752 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84680

Shortage status: discontinued (2025-08-26, reported by ORGANON CANADA INC.); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02361752

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Zenhale · DIN 02361760 · 200mcg & 5mcg · Metered Dose inhaler, 120 doses

Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02

Write on scriptLU code 330 (patient must meet the criteria below)

Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ontario Limited Use criteria — code 330

No interchangeable product listed in the Ontario extract

Zenhale · DIN 02361760 Manufacturer: Organon Canada Inc.; listing date 2012-02-29 Health Canada: Marketed since 2022-04-05 · brand ZENHALE · ATC R03AK09 FORMOTEROL AND MOMETASONE, R03AK09 FORMOTEROL AND MOMETASONE · form Aerosol (metered-dose) · route Inhalation · ingredients MOMETASONE FUROATE 200 MCG/ACT, FORMOTEROL FUMARATE DIHYDRATE 5 MCG/ACT · company Organon canada inc. · schedule Prescription

Check this DIN again · Health Canada product record

Zenhale: Formulary list price $157.3900/unit (unit not stated in source; not the patient's cost)

Ministry pays: $157.3900 per source unit.

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

Source record

DIN 02361760: Zenhale Raw flags: sec12=Y, sec3=Y Item: 121200096; group id 230; item number 0410; lccId 00220; manufacturer id OCI Source form: Metered Dose Inh-120 Dose Pk; strength: 200mcg & 5mcg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $157.3900; ministry $157.3900 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02361760 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84681

Shortage status: To be discontinued; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02361760

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

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

SALMETEROL XINAFOATE & FLUTICASONE PROPIONATE

· 11 products · Limited Use, codes 330 · strengths: 25/125mcg/Metered Dose, 25/250mcg/Metered Dose, 50/100mcg, 50/250mcg, 50/500mcg · Inh-120 Dose Pk, Inh-60 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

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

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

INDACATEROL & GLYCOPYRRONIUM

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

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. No displayed matched alternative is a general benefit. BUDESONIDE & FORMOTEROL FUMARATE DIHYDRATE · Limited Use, codes 330 INDICATIONS AND CLINICAL USE Asthma SYMBICORT TURBUHALER (budesonide and formoterol fumarate dihydrate) is indicated for the treatment of asthma in patients 12 years and older with reversible obstructive airways disease. PM: https://pdf.hres.ca/dpd_pm/00059997.PDF; date February 8, 2021; DIN 02245385; fetched 2026-09-10 Product monograph FLUTICASONE FUROATE & VILANTEROL · Limited Use, codes 330, 456 (1), Limited Use, codes 330 (1) Page 3 of 74 Asthma BREO ELLIPTA 100/25 mcg and BREO ELLIPTA 200/25 mcg are indicated for the once-daily maintenance treatment of asthma in patients aged 18 years and older with reversible obstructive airways disease. PM: https://pdf.hres.ca/dpd_pm/00049111.PDF; date January 7, 2019; DIN 02408872; fetched 2026-09-10 Product monograph INDACATEROL ACETATE & MOMETASONE FUROATE · Limited Use, codes 626 1 INDICATIONS ATECTURA BREEZHALER (indacaterol/mometasone furoate) is a combination of a long-acting beta2- adrenergic agonist (LABA) and an inhaled corticosteroid (ICS) indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older with reversible obstructive airways disease. PM: https://pdf.hres.ca/dpd_pm/00063537.PDF; date May 5, 2020; DIN 02498685; 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 ZENHALE® (mometasone furoate / formoterol fumarate dihydrate inhalation aerosol), is a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA) indicated for: • the treatment of asthma, in patients 12 years of age and older with reversible obstructive airway disease. ZENHALE should be prescribed for patients not adequately controlled on a long-term asthma control medication, such as an ICS, or whose disease severity clearly warrants treatment with both an ICS and a LABA. ZENHALE is not indicated for patients whose asthma can be managed by occasional use of a rapid onset, short duration, inhaled beta2-agonist, or for patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of a rapid onset, short duration, inhaled beta2-agonist. Once asthma control has been achieved and maintained, assess the patient at regular intervals. ZENHALE is not indicated for the relief of acute bronchospasm. 1.1 Pediatrics Pediatrics (< 12 years of age): The safety and efficacy of the available strengths of ZENHALE have not been established in children under 12 years of age. 1.2 Geria… https://pdf.hres.ca/dpd_pm/00080784.PDF PM date: 2025-06-09 Source product: ZENHALE; DIN 02361752; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Availability

Zenhale · DIN 02361752 Shortage status: discontinued (2025-08-26, reported by ORGANON CANADA INC.); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02361752

Check this DIN again

Zenhale · DIN 02361760 Shortage status: To be discontinued; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02361760

Check this DIN again