Germany· DE-A57-2dcaf8b1249fe908
Benda-5 Fu
A fluorouracil product containing fluorouracil, registered in Germany by Bendalis Gmbh. The same ATC class is registered in 14 of our 19 countries.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
Where it is registered
Fluorouracil is registered in 14 of 19 countries.
Countries holding a registration under ATC L01BC02 (fluorouracil), each read from that country’s own register.
- This record: Germany, from EMA Article 57 (European Union)
- 8 of them publish a price we can compare per daily dose
Fluorouracil · ATC L01BC02
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Fluorouracil
- Manufacturer
- Bendalis Gmbh
- Country
- Germany (DE)
- ATC code
- L01BC02
- ATC class
- Fluorouracil
- Defined daily dose
- 0.15 g, O
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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.
Interactions
401 interactions on record for fluorouracil.
Graded by severity as the source publishes them — 36 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Fluorouracil · interactions on record
401 records
- 36 severe
- 119 moderate
- 18 minor
- 227 info
Most severe, free to view
- DicoumarolB01AA01severe
- WarfarinB01AA03severe
- Folic acidB03BB01severe
- CladribineL01BB04severe
1 more interaction with mechanism and management, from a commercially licensed source.
Sign in to check- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Fluorouracil in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomCarac 0.5% creamImported (United States)
- United StatesEfudexBausch Health US, LLC
- SwitzerlandEfudix
- BelgiumEfflurak 40 mg/gPierre Fabre Médicament
- Czechia5-FLUOROURACIL EBEWEEBEWE Pharma Ges.m.b.H Nfg.KG, Unterach
- SwedenFluorouracil Accord 50 mg/ml Injektions-/infusionsvätska, lösningAccord Healthcare B.V.
- NorwayEfudix specificMeda
- FinlandFluorouracil AccordOrifarm Oy
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
- Denmark · Fluorouracil Accord, Tolak
- Estonia · 5-Fluorouracil Ebewe, Fluorouracil Accord
- Spain · Fluorouracilo Accord, Tolak
- 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 EMA Article 57 (European Union). 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/66f10270-b9d9-4f67-b3a6-50ba9acb5ff3 GET /v1/drugs/66f10270-b9d9-4f67-b3a6-50ba9acb5ff3?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.
{
"pzn": null,
"route": "Intravenous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Fluorouracil",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about fluorouracil.
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.