Netherlands· NL-76bbee5e1b86

Daxas 500 microgram filmomhulde tabletten

A roflumilast product containing roflumilast, registered in Netherlands by AstraZeneca AB. The same ATC class is registered in 12 of our 19 countries.

ATC R03DX07

Checked against CBG-MEB (Netherlands) on September 29, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about roflumilastAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

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: Netherlands, from CBG-MEB (Netherlands)
8 of them publish a price we can compare per daily dose

Search roflumilast products by name

Roflumilast · ATC R03DX07

12 / 19 countries

Belgiumprice
Canada
Czechiaprice
Denmark
Finlandprice
Icelandprice
Ireland
Italyprice
Netherlands
Norwayprice
Polandprice
Switzerlandprice

Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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

Open the full comparison — free account Drug prices for market access

Roflumilast · price per daily dose (0.5 mg)

USD · FX 28 Sept 2026

CH Switzerland$3.02
IT Italy$2.50

Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

CBG-MEB (Netherlands)

Active substance: ROFLUMILAST
Manufacturer: AstraZeneca AB
Country: Netherlands (NL)
ATC code: R03DX07
ATC class: Roflumilast
Defined daily dose: 0.5 mg, O
Reimbursed: Not published by this register
Source register: CBG-MEB (Netherlands)
Last checked: September 29, 2026

Packs & prices · 1

cbg_meb_id
EU/1/10/636

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

Check roflumilast against other medicines How interaction checks work

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.

Mechanism and what to do, in the interaction check

Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All roflumilast products

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 CBG-MEB (Netherlands). 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/7fcdaeaa-cb60-4145-828e-165cf963f6ce
GET /v1/drugs/7fcdaeaa-cb60-4145-828e-165cf963f6ce?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": "Filmomhulde tablet",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/daxas-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Roflumilast",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp105451",
  "excipients": [
    "HYPROMELLOSE 2910 (3 - 15 mPa.s) (E 464)",
    "IJZEROXIDE GEEL (E 172)",
    "LACTOSE 1-WATER",
    "MACROGOL 4000",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MAÏSZETMEEL",
    "POVIDON K 90 (E 1201)",
    "TITAANDIOXIDE (E 171)"
  ],
  "substances": [
    "ROFLUMILAST"
  ],
  "leaflet_url": null,
  "authorised_at": "2010/07/05",
  "procedure_number": "EMEA/H/C/001179",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/10/636",
  "additional_monitoring": "Y"
}

API reference MCP server Plans

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.

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