BREO ELLIPTA 25 MCG
VILANTEROL (VILANTEROL TRIFENATATE) : 25 MCG FLUTICASONE FUROATE : 100 MCG · DIN 02408872 · GLAXOSMITHKLINE INC
Health Canada status: MARKETED
What is BREO ELLIPTA?
BREO ELLIPTA 25 MCG contains VILANTEROL (VILANTEROL TRIFENATATE) : 25 MCG FLUTICASONE FUROATE : 100 MCG. It is listed in the Health Canada Drug Product Database under DIN 02408872, held by GLAXOSMITHKLINE INC, supplied as POWDER for INHALATION administration. Health Canada currently lists it as marketed, status dated 29-Nov-2013. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is BREO ELLIPTA used for?
Long-term once-daily maintenance treatment of airflow obstruction in COPD and reduction of exacerbations. Maintenance treatment of asthma in patients 18+ years. Not for acute bronchospasm.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02408872 |
|---|---|
| Brand name | BREO ELLIPTA |
| Generic / active ingredient | VILANTEROL (VILANTEROL TRIFENATATE) : 25 MCG FLUTICASONE FUROATE : 100 MCG |
| Manufacturer | GLAXOSMITHKLINE INC |
| Strength | 25 MCG |
| Dosage form | POWDER |
| Route of administration | INHALATION |
| Schedule | Prescription |
| ATC code | R03AK10 VILANTEROL AND FLUTICASONE FUROATE |
| AHFS class | 28:12.92 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 29-Nov-2013 |
| Original market date | 2023-08-25 00:00:00 |
How is it administered?
Once-daily maintenance treatment. COPD: 100/25 mcg. Asthma: 100/25 mcg or 200/25 mcg. Not for acute symptoms. Rinse mouth with water after use.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
(Specific temperature range not in provided text summary; refer to full monograph).
How is it supplied?
Dry powder for oral inhalation in the ELLIPTA inhaler. (Detailed packaging info not in provided text summary).
Contraindications
Hypersensitivity to fluticasone furoate, vilanterol, or any ingredient; severe hypersensitivity to milk proteins; primary treatment of status asthmaticus or acute episodes of asthma.
Warnings and precautions
Not for acute use. Risk of serious asthma-related events. Potential for pneumonia in COPD. Risk of HPA axis suppression, reduced BMD, and cardiovascular effects. Paradoxical bronchospasm may occur.
What can be used instead?
Other Canadian products sharing ATC code R03AK10 VILANTEROL AND FLUTICASONE FUROATE. 2 of 2 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| BREO ELLIPTA | 25 MCG | POWDER | GLAXOSMITHKLINE INC | MARKETED | DIN 02444186 |
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.