Germany· DE-A57-19835f5d5232750c
Efudix
A fluorouracil product containing fluorouracil, registered in Germany by Viatris Healthcare Gmbh. The same ATC class is registered in 3 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 3 of 19 countries.
Countries holding a registration under ATC D11AF05 (fluorouracil), each read from that country’s own register.
- This record: Germany, from EMA Article 57 (European Union)
- 1 of them publish a price we can compare per daily dose
Fluorouracil · ATC D11AF05
3 / 19 countries
- Germany
- United Kingdom
- United Statesprice
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Fluorouracil
- Manufacturer
- Viatris Healthcare Gmbh
- Country
- Germany (DE)
- ATC code
- D11AF05
- ATC class
- Fluorouracil
- 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.
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 AccordAccord Healthcare B.V.
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/73eb1790-64b5-454d-a59b-b4fc6ae19d7a GET /v1/drugs/73eb1790-64b5-454d-a59b-b4fc6ae19d7a?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": "Cutaneous 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.