DAXAS 500 MCG — DIN 02359456
ROFLUMILAST : 500 MCG · ASTRAZENECA CANADA INC · TABLET · wholesale supply in Canada
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.
How much does Roflumilast cost around the world?
Roflumilast is listed on 12 of the national price registers Nexara ingests. Each country publishes on a different basis, so figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Austria publishes a KVP (Kassenverkaufspreis); Bahrain publishes a retail (max); Czechia publishes a max producer price (ex-factory). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed |
|---|---|---|---|
| United States | acquisition | 2 | 34 |
| Sweden | AIP (pharmacy purchase price) | 4 | 15 |
| Norway | max AUP (pharmacy retail) | 3 | 9 |
| Saudi Arabia | public | 2 | 5 |
| Czechia | max producer price (ex-factory) | 2 | 4 |
| Spain | PVP con IVA (public price) | 4 | 4 |
| Greece | producer price (ex-factory) | 3 | 3 |
| Austria | KVP (Kassenverkaufspreis) | 2 | 2 |
| Italy | prezzo al pubblico (classe A) | 2 | 2 |
| Bahrain | retail (max) | 1 | 1 |
| Slovakia | categorised final price | 1 | 1 |
| South Africa | single exit price | 1 | 1 |
81 pack listings across 27 brand entries and 12 price bases, refreshed 07 Sep 2026. Ranges span every Roflumilast pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 500 MCG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in the provided text (section header exists but content is missing from snippet). |
| Storage | Not explicitly detailed in the provided text (section header exists but content is missing from snippet). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Roflumilast |
|---|---|
| ATC code | R03DX07 |
| AHFS class | 48:32.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02359456 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2359456 |
| Brand name | DAXAS |
| Generic / active ingredient | ROFLUMILAST : 500 MCG |
| Market authorization holder | ASTRAZENECA CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | R03DX07 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R03DX |
| Current status | MARKETED |
| Status date | 20-Jul-2017 |
| Original market date | 2010-12-30 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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.
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.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
2 · Same class — other molecules in ATC R03DX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Omalizumab | OMLYCLO · XOLAIR | 9 | 8 | Yes |
| Mepolizumab | NUCALA | 4 | 3 | Yes |
| Benralizumab | FASENRA · FASENRA PEN | 2 | 2 | Yes |
| Tezepelumab | TEZSPIRE | 2 | 2 | Yes |
| Reslizumab | CINQAIR | 1 | 1 | Yes |
| Roflumilast | DAXAS | 1 | 1 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC R03D
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R03DC | Montelukast · Zafirlukast | 98 | 41 |
| R03DA | Aminophylline · Choline Theophyllinate · Diprophylline · Theophylline · Theophylline, Combinations Excl. Psycholeptics | 82 | 8 |
| R03DB | Theophylline And Adrenergics | 1 | 0 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is DAXAS called?
The same molecule, Roflumilast, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Roflumilast Accord | Latin | Norway, Sweden |
| Firekol | Latin | Norway |
| RUMIXAFEN | Latin | Czechia |
| LEMITAT | Latin | Bahrain |
| Roflumilast Medartuum | Latin | Sweden |
| Roflumilast Orifarm | Latin | Sweden |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.