Spain· ES:84849
TOLAK 40 MG/G CREMA
A medicinal product containing fluorouracilo, registered in Spain by Pierre Fabre Iberica S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- fluorouracilo
- Manufacturer
- Pierre Fabre Iberica S.A.
- 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_codigo72790420EUR 40.07
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Fluorouracilo in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwedenTolak 40 mg/g KrämMedartuum AB
- NorwayTolakPierre Fabre Medicament
- CzechiaTOLAKPIERRE FABRE MEDICAMENT, Lavaur
- SwitzerlandTolak 40 mg/g, CremePierre Fabre Pharma SA
- FinlandTolerakParanova Oy
- United StatesTOLAKHILL DERMACEUTICALS, INC.
- FranceTOLAK 40 mg/g, crèmePIERRE FABRE MEDICAMENT
- NetherlandsTolak 40 mg/g crèmePierre Fabre Medicament
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · 5-Fluorouracil Ebewe, Fluorouracil Accord
- Belgium · Efflurak, Efudix
- Bulgaria · 5-Флуороурацил “ебеве”, Флуороурацил Акорд
- Cyprus · Fluorouracil Accord
- Czechia · 5-Fluorouracil Ebewe, Fluorouracil Accord
- Germany · 5-Fu Medac, Benda-5 Fu
- Denmark · Fluorouracil Accord, Tolak
- Estonia · 5-Fluorouracil Ebewe, Fluorouracil Accord
- Finland · Fluorouracil Accord, Tolerak
- France · Efudix, Fluorouracile Accord
- United Kingdom (Northern Ireland) · Efudix, Fluorouracil Accord Healthcare
- Greece · Fluorouracil Anabiosis, Fluorouracil Opus
- Croatia · Fluorouracil Accord, Fluorouracil Sandoz
- Hungary · 5-Fluorouracil Ebewe, 5-Fluorouracil Sandoz
- Ireland · Efudix, Fluorouracil Accord
- Iceland · Flúoróúracíl Accord
- Italy · Fluorouracil Teva, Fluorouracile Ahcl
- Lithuania · Fluorouracil Accord
- Luxembourg · Efflurak, Efudix
- Latvia · Fluorouracil Accord
- Malta · Efudix
- Netherlands · Efudix, Fluorouracil Accord
- Norway · Fluorouracil Accord, Tolak
- Poland · 5-Fluorouracil Ebewe, Efudix
- Portugal · Efflurak, Fluorouracilo Accord
- Romania · 5-Fluorouracil, 5-Fluorouracil Ebewe
- Sweden · Fluorouracil Accord, Fluorouracil Teva
- Slovenia · 5-Fluorouracil Ebewe, Fluorouracil Accord
- Slovakia · Efudix, Fluorouracil Accord
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/8c08f5c5-aa24-4cd3-9bc0-7ac7e61c0a8c GET /v1/drugs/8c08f5c5-aa24-4cd3-9bc0-7ac7e61c0a8c?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\":1580901179000}",
"nregistro": "84849",
"substance": "fluorouracilo"
}See everything about fluorouracilo.
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.