Spain· ES:84878
SILESTO 50 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG
A medicinal product containing quetiapina, registered in Spain by Laboratorio Stada S.L..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- quetiapina
- Manufacturer
- Laboratorio Stada S.L.
- 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
Quetiapina in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomAtrolak XL 50mg tabletsAccord-UK Ltd
- FranceQUETIAPINE ACCORD LP 50 mg, comprimé à libération prolongéeACCORD HEALTHCARE FRANCE
- BelgiumQuetiapin Retard Sandoz 50 mgSandoz
- FinlandBiquetanSTADA Arzneimittel AG
- CzechiaKVENTIAX PROLONGKrka, d.d., Novo mesto, Novo mesto
- CanadaACH-QUETIAPINE FUMARATE XRACCORD HEALTHCARE INC
- NetherlandsQuetiapine Accord 50 mg tabletten met verlengde afgifteAccord Healthcare B.V.
- NorwayKwetaplex XRAdamed Pharma
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Quetialan, Quetialan 4 Tage Startpackung
- Belgium · Ketyalix, Quetiapin Retard Sandoz
- Bulgaria · Centroqueen, Бревенокс
- Cyprus · Aquetia, Ketipine
- Czechia · Derin, Derin Prolong
- Germany · Aquetia, Desiquet
- Denmark · Antoreq, Biquetan
- Estonia · Ketipinor, Kventiax
- Finland · Biquetan, Ketipinor
- France · Lp, Queliva
- United Kingdom (Northern Ireland) · Alaquet Xl, Atrolak Xl
- Greece · Anaquetan Xr, Aquetia
- Croatia · Kventiax, Kventiax Sr
- Hungary · Ketilept, Ketilept Prolong
- Ireland · Notiabolfen Xl, Quentiax Sr
- Iceland · Quetiapin Actavis, Quetiapin Krka
- Italy · Akelya, Quentiax
- Lithuania · Hedonin, Ketipinor
- Luxembourg · Aquetia, Quetiapine Eg
- Latvia · Ketipinor, Kventiax
- Malta · Quetex, Quetex Xr 50mg
- Netherlands · Aquetia, Quetiapine
- Norway · Quetiapin Krka, Quetiapin Orion
- Poland · Apotiapina, Apotiapina Pr
- Portugal · Anaquetan Xr, Aquetia
- Romania · Kventiax, Kventiax Ep
- Sweden · Biquetan, Quetiapin Hexal
- Slovenia · Kvelux, Kvelux Sr
- Slovakia · Derin, Derin Prolong
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/f16e707a-b89a-43d8-afdd-b9c66314747a GET /v1/drugs/f16e707a-b89a-43d8-afdd-b9c66314747a?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\":1581634800000,\"rev\":1652271691000}",
"nregistro": "84878",
"substance": "quetiapina"
}See everything about quetiapina.
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.