Ireland· IE-PA-EU/1/10/636/008
Daxas 250 micrograms tablets
A roflumilast product containing roflumilast, registered in Ireland by AstraZeneca AB. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Roflumilast is registered in 12 of 19 countries.
Countries holding a registration under ATC R03DX07 (roflumilast), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 8 of them publish a price we can compare per daily dose
Roflumilast · ATC R03DX07
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
Price per daily dose
What a daily dose of roflumilast costs, country by country.
Normalised to the WHO defined daily dose (0.5 mg), so markets compare like for like.
- 2 markets with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Roflumilast · price per daily dose (0.5 mg)
USD · FX 28 Sept 2026
- CH Switzerland$3.02
- IT Italy$2.50
The record
At a glance
HPRA (Ireland)- Active substance
- Roflumilast
- Manufacturer
- AstraZeneca AB
- Country
- Ireland (IE)
- ATC code
- R03DX07
- ATC class
- Roflumilast
- Defined daily dose
- 0.5 mg, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/10/636/008
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
352 interactions on record for roflumilast.
Graded by severity as the source publishes them — 2 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Roflumilast · interactions on record
352 records
- 2 severe
- 347 moderate
- 3 minor
Most severe, free to view
- CladribineL01BB04severe
- CimetidineA02BA01moderate
- Obeticholic acidA05AA04moderate
- PrednisoloneA07EA01moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Roflumilast in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesDalirespAstraZeneca Pharmaceuticals LP
- United KingdomDaxas 250microgram tabletsAstraZeneca UK Ltd
- SpainDAXAS 250 MICROGRAMOS COMPRIMIDOSAstrazeneca Ab
- NorwayDaxasAstraZeneca AB
- SwedenDaxas 250 mikrogram TablettAstraZeneca AB
- NetherlandsDaxas 250 microgram tablettenAstraZeneca AB
- FinlandDaxasAstraZeneca AB
- CzechiaDAXASAstraZeneca AB, Södertälje
Authorised across Europe · EMA
The same active substance is authorised in 15 EEA countries. Names it is sold under:
- Austria · Rofluma, Roflumilast Accord
- Cyprus · Damirast
- Czechia · Rumixafen
- Germany · Roflum Hexal, Roflumila Puren
- Denmark · Firekol
- Spain · Roflumilast Aurovitas
- Finland · Firekol
- United Kingdom (Northern Ireland) · Roflumilast Milpharm, Roflumilast Torrent Pharma (Uk)
- Greece · Damirast
- Iceland · Daxas
- Liechtenstein · Daxas
- Norway · Daxas, Firekol
- Portugal · Roflumilaste Generis
- Sweden · Firekol, Roflumilast Accord
- Slovakia · Rumixafen
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/8109d3e0-2235-4358-bb4b-54bdfa547197 GET /v1/drugs/8109d3e0-2235-4358-bb4b-54bdfa547197?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"R03DX",
"R03DX07"
],
"strength": null,
"pa_number": "EU/1/10/636/008",
"substances": [
"Roflumilast"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": null,
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about roflumilast.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.