Spain· ES:57184
DIFATEROL RETARD 400 mg COMPRIMIDOS DE LIBERACION PROLONGADA
A medicinal product containing bezafibrato, registered in Spain by Laboratorios Bial S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- bezafibrato
- Manufacturer
- Laboratorios Bial S.A.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- June 3, 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
Bezafibrato in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomBezafibrate 400mg modified-release tabletsPhoenix Healthcare Distribution Ltd
- NetherlandsBezalip Retard 400 mg, tabletten met gereguleerde afgifteEuro Registratie Collectief B.V.
- FinlandBezafibrat GenericsGenerics (UK) Limited
- NorwayBezalip RetardAurobindo Pharma
- CanadaBEZALIP SRALLERGAN INC
- SwedenBezalip Retard 400 mg DepottablettActavis Group PTC ehf.
- FranceBEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongéeARROW GENERIQUES
- BelgiumEulitop 400 mgAurobindo
Authorised across Europe · EMA
The same active substance is authorised in 14 EEA countries. Names it is sold under:
- Austria · Bezalip Retard, Bezastad
- Belgium · Cedur, Eulitop
- Cyprus · Lacromid, Zafibral
- Germany · Bezafibrat Al, Bezafibrat Retard Al
- Finland · Bezalip
- France · Befizal, Befizal L.P.
- United Kingdom (Northern Ireland) · Bezafibrate, Bezafibrate Noumed Life Sciences
- Hungary · Bezalip
- Italy · Bezalip
- Luxembourg · Cedur, Eulitop
- Netherlands · Bezafibrate Aurobindo
- Portugal · Bezalip, Bezalip Retard
- Romania · Bezafibrat Arena
- Sweden · Bezalip, Bezalip Retard
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/b75b27f8-21ef-470f-89b7-1f1ee9b1fd10 GET /v1/drugs/b75b27f8-21ef-470f-89b7-1f1ee9b1fd10?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. Tratamiento De Larga Duración",
"estado": "{\"aut\":544226400000,\"rev\":1648024647000}",
"nregistro": "57184",
"substance": "bezafibrato"
}See everything about bezafibrato.
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.