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Italy· 046491015

TOLERAK*1 tubo crema 20 g 40 mg/g

A medicinal product containing fluorouracile, registered in Italy by PIERRE FABRE ITALIA SpA, on the national reimbursement list.

Reimbursed in Italy (AIFA class A)

Checked against the register on

Informational only — not a medical device.

SOURCE REGISTER · ITPublic registernormalisedTOLERAK*1 tubo crema 20 g 40 mg/gATC—REGISTER NO.046491015PACKS LISTED1CHECKEDJune 4, 2026

The record

At a glance

Active substance
Fluorouracile
Manufacturer
PIERRE FABRE ITALIA SpA
Country
Italy (IT)
ATC code
—
Reimbursed
Yes
Last checked
June 4, 2026

Packs & prices · 1

1 priced
  • aic
    046491015
    TOLERAK*1 tubo crema 20 g 40 mg/g
    EUR 72.99

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Fluorouracile in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All fluorouracile products

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
  • Ireland · Efudix, Fluorouracil Accord
  • Iceland · Flúoróúracíl Accord
  • 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 the issuing authority. 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/d42fe32b-9a1d-4b37-85e1-7bdf50d06494
GET /v1/drugs/d42fe32b-9a1d-4b37-85e1-7bdf50d06494?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.

{
  "price": 72.99,
  "source": "aifa",
  "currency": "EUR",
  "strength": "FLUOROURACILE 20G 40MG/G CREMA USO DERMATOLOGICO",
  "substance": "Fluorouracile",
  "equivalence_group": "LLZ",
  "transparency_flag": null
}

See everything about fluorouracile.

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.