Germany· DE-A57-879149dc9a4de9f2
Roflum Hexal
A roflumilast product containing roflumilast, registered in Germany by Hexal Ag. The same ATC class is registered in 3 of our 19 countries.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
Where it is registered
Roflumilast is registered in 3 of 19 countries.
Countries holding a registration under ATC Roflumilast (roflumilast), each read from that country’s own register.
- This record: Germany, from EMA Article 57 (European Union)
- 1 of them publish a price we can compare per daily dose
Roflumilast · ATC Roflumilast
3 / 19 countries
- Germany
- United Kingdom
- United Statesprice
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Roflumilast
- Manufacturer
- Hexal Ag
- Country
- Germany (DE)
- ATC code
- Roflumilast
- ATC class
- Roflumilast
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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
- CzechiaDAXASAstraZeneca AB, Södertälje
- SwedenDaxas 250 mikrogram TablettAstraZeneca AB
- United KingdomDaxas 250microgram tabletsAstraZeneca UK Ltd
- SpainDAXAS 250 MICROGRAMOS COMPRIMIDOSAstrazeneca Ab
- FinlandDalirespAstraZeneca AB
- BelgiumDaliresp 500 µgAstraZeneca
- CanadaDAXASASTRAZENECA CANADA INC
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
- Czechia · Rumixafen
- 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 EMA Article 57 (European Union). 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/6cbe2896-405a-4beb-be26-d36bf2071545 GET /v1/drugs/6cbe2896-405a-4beb-be26-d36bf2071545?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.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Roflumilast",
"atc_from_source": null,
"authorisation_country": "Germany"
}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.