Spain· ES:85529
ROFLUMILAST AUROVITAS 500 MICROGRAMOS COMPRIMIDOS EFG
A medicinal product containing roflumilast, registered in Spain by Aurovitas Spain, S.A.U..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- roflumilast
- Manufacturer
- Aurovitas Spain, S.A.U.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cima_codigo72962730EUR 34.69
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
- United KingdomDaxas 500microgram tabletsMawdsley-Brooks & Company Ltd
- CanadaDAXASASTRAZENECA CANADA INC
- CzechiaDAXASAstraZeneca AB, Södertälje
- GermanyRoflum HexalHexal Ag
- SwedenDaxas 250 mikrogram TablettAstraZeneca AB
- FinlandDalirespAstraZeneca AB
- BelgiumDaliresp 500 µgAstraZeneca
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
- 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 AEMPS CIMA (Spain). 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/2bc0a07d-fd52-412c-a212-7eae3b37fb8d GET /v1/drugs/2bc0a07d-fd52-412c-a212-7eae3b37fb8d?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.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":1603815586000}",
"nregistro": "85529",
"substance": "roflumilast"
}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.