Ireland· IE-PA-PA23355/026/001
Efudix 5 % w/w Cream
A fluorouracil product containing fluorouracil, registered in Ireland by Viatris Healthcare Limited. The same ATC class is registered in 14 of our 19 countries.
Checked against HPRA (Ireland) 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: Ireland, from HPRA (Ireland)
- 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
HPRA (Ireland)- Active substance
- Fluorouracil
- Manufacturer
- Viatris Healthcare Limited
- Country
- Ireland (IE)
- ATC code
- L01BC02
- ATC class
- Fluorouracil
- Defined daily dose
- 0.15 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA23355/026/001
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.
- Germany5-Fu MedacMedac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)
- NorwayEfudix specificMeda
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
- 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
- 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 HPRA (Ireland). 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/cf993540-8a29-4358-8a12-2a20bb6ae5a2 GET /v1/drugs/cf993540-8a29-4358-8a12-2a20bb6ae5a2?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.
{
"form": "Cream",
"routes": [
"Topical"
],
"source": "hpra",
"atc_all": [
"L01BC",
"L01BC02"
],
"strength": null,
"pa_number": "PA23355/026/001",
"substances": [
"Fluorouracil"
],
"legal_basis": "Not Currently Available",
"market_info": "Marketed",
"authorised_at": "01/04/1979",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}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.