APO-AZELASTINE/FLUTICASONE 137 MCG
AZELASTINE HYDROCHLORIDE : 137 MCG FLUTICASONE PROPIONATE : 50 MCG · DIN 02540886 · APOTEX INC
Health Canada status: MARKETED
What is APO-AZELASTINE/FLUTICASONE?
APO-AZELASTINE/FLUTICASONE 137 MCG contains AZELASTINE HYDROCHLORIDE : 137 MCG FLUTICASONE PROPIONATE : 50 MCG. It is listed in the Health Canada Drug Product Database under DIN 02540886, held by APOTEX INC, supplied as SPRAY, METERED DOSE for NASAL administration. Health Canada currently lists it as marketed, status dated 31-Oct-2023. 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 APO-AZELASTINE/FLUTICASONE used for?
APO-AZELASTINE/FLUTICASONE (azelastine hydrochloride and fluticasone propionate suspension nasal spray) is indicated for: • the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older.
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 | 02540886 |
|---|---|
| Brand name | APO-AZELASTINE/FLUTICASONE |
| Generic / active ingredient | AZELASTINE HYDROCHLORIDE : 137 MCG FLUTICASONE PROPIONATE : 50 MCG |
| Manufacturer | APOTEX INC |
| Strength | 137 MCG |
| Dosage form | SPRAY, METERED DOSE |
| Route of administration | NASAL |
| Schedule | Prescription |
| ATC code | R01AD58 FLUTICASONE, COMBINATIONS |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 31-Oct-2023 |
How is it stored and handled?
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How is it supplied?
25 mL amber glass vials containing 23.0 g of drug product and at least 120 actuations
What can be used instead?
Other Canadian products sharing ATC code R01AD58 FLUTICASONE, COMBINATIONS. 3 of 3 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 |
|---|---|---|---|---|---|
| DYMISTA | 50 MCG | SPRAY, METERED DOSE | BGP PHARMA ULC | MARKETED | DIN 02432889 |
| MYLAN-AZELASTINE/FLUTICASONE | 137 MCG | SPRAY, METERED DOSE | MYLAN PHARMACEUTICALS ULC | MARKETED | DIN 02530341 |
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.