Czechia· CZ-0167746
DAXAS
A roflumilast product containing roflumilast, registered in Czechia by AstraZeneca AB, Södertälje. The same ATC class is registered in 12 of our 19 countries.
Checked against SÚKL (Czech Republic) 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: Czechia, from SÚKL (Czech Republic)
- 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
SÚKL (Czech Republic)- Active substance
- ROFLUMILAST
- Manufacturer
- AstraZeneca AB, Södertälje
- Country
- Czechia (CZ)
- ATC code
- R03DX07
- ATC class
- Roflumilast
- Defined daily dose
- 0.5 mg, O
- Reimbursed
- Not published by this register
- Source register
- SÚKL (Czech Republic)
- Last checked
- September 28, 2026
Packs & prices · 1
1 priced- cz_kod_sukl016774630CZK 1351.37
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.
- SwedenDaxas 500 mikrogram Filmdragerad tablettAstraZeneca AB
- FinlandDalirespAstraZeneca AB
- BelgiumDaliresp 500 µgAstraZeneca
- SpainDAXAS 500 MICROGRAMOS COMPRIMIDOS RECUBIERTOS CON PELICULAAstrazeneca Ab
- NorwayDaxasAstraZeneca AB
- IrelandDaxas 500 micrograms film-coated tabletsAstraZeneca AB
- NetherlandsDaxas 500 microgram filmomhulde tablettenAstraZeneca AB
- PolandDaxasAstraZeneca AB
Authorised across Europe · EMA
The same active substance is authorised in 14 EEA countries. Names it is sold under:
- Austria · Rofluma, Roflumilast Accord
- Cyprus · Damirast
- 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 SÚKL (Czech Republic). 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/31479f2f-e9bf-44c1-9f4d-4948290c9278 GET /v1/drugs/31479f2f-e9bf-44c1-9f4d-4948290c9278?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": "TBL FLM",
"source": "sukl",
"strength": "500MCG",
"pack_size": "30",
"substance": "ROFLUMILAST",
"cz_kod_sukl": "0167746",
"product_type": "CH",
"substance_codes": "15294",
"registration_state": "R",
"registration_number": "EU/1/10/636/002"
}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.