DAXAS 500 MCG
ROFLUMILAST : 500 MCG · DIN 02359456 · ASTRAZENECA CANADA INC
Health Canada status: MARKETED
What is DAXAS?
DAXAS 500 MCG contains ROFLUMILAST : 500 MCG. It is listed in the Health Canada Drug Product Database under DIN 02359456, held by ASTRAZENECA CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 20-Jul-2017. 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 DAXAS used for?
Add-on therapy to bronchodilator treatment for maintenance treatment of severe COPD associated with chronic bronchitis in adults with a history of frequent exacerbations.
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 | 02359456 |
|---|---|
| Brand name | DAXAS |
| Generic / active ingredient | ROFLUMILAST : 500 MCG |
| Manufacturer | ASTRAZENECA CANADA INC |
| Strength | 500 MCG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | R03DX07 ROFLUMILAST |
| AHFS class | 48:32.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 20-Jul-2017 |
| Original market date | 2010-12-30 00:00:00 |
How is it administered?
Recommended dose is 500 mcg once daily, with or without food. Not for rescue use. Reassess treatment in case of persistent intolerability.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
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How is it supplied?
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Contraindications
Hypersensitivity to roflumilast or any ingredient; moderate or severe hepatic impairment (Child-Pugh B or C).
Warnings and precautions
Not for acute bronchospasm. Risk of neuropsychiatric events (suicide, depression, anxiety). Monitor for weight loss and diarrhea. Not for patients with severe immunological or infectious diseases.
Who else supplies ROFLUMILAST worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ROFLUMILAST appears in 32 registered pack listings across 9 markets, published on 9 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.