Spain· ES:84001
SAFENTIL 50 MICROGRAMOS/ML SOLUCION INYECTABLE Y PARA PERFUSION EFG
A medicinal product containing sufentanilo, registered in Spain by Medochemie Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- sufentanilo
- Manufacturer
- Medochemie Limited
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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
Sufentanilo in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaSONTILENMedochemie Ltd., Limassol
- BelgiumSufentanil Hameln 50 µg/mlHameln Pharma
- FinlandSufenta FortePiramal Critical Care B.V.
- PolandSufentanil hamelnhameln Pharma GmbH
- NorwaySufentanil hamelnhameln pharma GmbH
- SwedenSufentanil hameln 50 mikrogram/ml Injektions-/infusionsvätska, lösningHameln Pharma gmbh
- DenmarkSufentanil "Kalceks"Kalceks AS
- GermanySufentaPiramal Critical Care B.V.
Authorised across Europe · EMA
The same active substance is authorised in 25 EEA countries. Names it is sold under:
- Austria · Sufenta, Sufentanil Hameln
- Belgium · Sufenta, Sufenta Forte
- Cyprus · Sofentil
- Czechia · Sontilen, Sufenta
- Germany · Sufenta, Sufenta Epidural
- Denmark · Sofentil, Sufenta
- Finland · Sufenta, Sufenta Forte
- France · Sufenta, Sufentanil Renaudin
- United Kingdom (Northern Ireland) · Dzuveo
- Croatia · Sofentil, Sufentanil Altamedics
- Hungary · Sufentanil Hameln, Sufentanil Torrex
- Iceland · Dzuveo, Sufenta
- Italy · Disufen, Sufentanil Hameln
- Liechtenstein · Dzuveo, Sufenta
- Luxembourg · Sufenta, Sufenta Forte
- Latvia · Sontilen
- Malta · Sofentil
- Netherlands · Narcomed, Sufenta
- Norway · Dzuveo, Sufenta
- Poland · Sufentanil Chiesi, Sufentanil Hameln
- Portugal · Sontilen, Sufenta
- Romania · Sofentil
- Sweden · Sufenta, Sufentanil Hameln
- Slovenia · Sufentanil Hameln
- Slovakia · Sofentil, Sufentanil Chiesi
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/b9f31de3-d6f8-4df9-8162-fe6a1c16e7bb GET /v1/drugs/b9f31de3-d6f8-4df9-8162-fe6a1c16e7bb?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": "Uso Hospitalario. Estupefacientes",
"estado": "{\"aut\":1554156000000}",
"nregistro": "84001",
"substance": "sufentanilo"
}See everything about sufentanilo.
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.