Sweden· SE-20220630000049
Firekol 500 mikrogram Filmdragerad tablett
A medicinal product containing roflumilast, registered in Sweden by 2care4 Generics ApS.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Roflumilast
- Manufacturer
- 2care4 Generics ApS
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20220630000049
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.
- CzechiaDAXASAstraZeneca AB, Södertälje
- 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
- 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
- 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 Swedish Medical Products Agency (Sweden). 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/c10888e8-cd71-4ee7-8fbe-6ef52cb2c108 GET /v1/drugs/c10888e8-cd71-4ee7-8fbe-6ef52cb2c108?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.
{
"source": "lakemedelsverket",
"doc_types": [
"PL",
"SmPC"
],
"se_npl_id": "20220630000049",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20220630000049",
"product_doc_link": "https://docetp.mpa.se/LMF/Firekol%20film-coated%20tablet%20SmPC_09001bee83b42bfc.pdf"
}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.