Belgium· BE-AMP-SAM281513-00

Candizole 200 mg

A fluconazole product containing fluconazole, registered in Belgium by Mithra Pharmaceuticals.

ATC D01AC15

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedCandizole 200 mgATCD01AC15REGISTER NO.BE-AMP-SAM281513-00PACKS LISTED2CHECKEDSeptember 26, 2026

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Fluconazole
Manufacturer
Mithra Pharmaceuticals
Country
Belgium (BE)
ATC code
D01AC15
ATC class
Fluconazole
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    2385342
  • be_apb
    2385359

Regulatory notes

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

Same medicine, other countries

Fluconazole in 16 other countries

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

All fluconazole products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Diflucan, Difluzol
  • Bulgaria · Exomax, Дифлазон
  • Cyprus · Dilapan, Fluconazole Noridem
  • Czechia · Diflucan, Fluconazol Kabi
  • Germany · Diflucan, Diflucan Derm
  • Denmark · Diflucan, Fluconazol "hexal"
  • Estonia · Diflazon, Diflucan
  • Spain · Candifix, Diflucan
  • Finland · Diflucan, Fluconazol Fresenius Kabi
  • France · Beagyne, Fluconazole Aguettant
  • United Kingdom (Northern Ireland) · Azocan, Azocan-P
  • Greece · Afloxol, Azoflu
  • Croatia · Diflucan, Fluconax
  • Hungary · Dermyc, Diflazon
  • Ireland · Caneclear, Canoral
  • Iceland · Candizol, Diflucan
  • Italy · Alozof, Aviflucox
  • Lithuania · Diflazon, Diflucan
  • Luxembourg · Diflucan, Fluconazol Ab
  • Latvia · Diflucan, Fluconazole Actavis
  • Malta · Flucol, Fluconazole Accord Healthcare
  • Netherlands · Diflucan, Fluconazol Accord
  • Norway · Canesoral, Diflucan
  • Poland · Candifluc, Diflucan
  • Portugal · Diflucan, Fluconazol Alter
  • Romania · Diflucan, Fluconazol Arena
  • Sweden · Diflucan, Fluconazol Actavis
  • Slovenia · Diflazon, Diflucan
  • Slovakia · Diflucan, Diflucan P.O.S.

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 FAMHP / AFMPS (Belgium). 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/2322eccd-068e-4e50-a239-578b6101a83a
GET /v1/drugs/2322eccd-068e-4e50-a239-578b6101a83a?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": "Capsule, hard",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Candizole 200 mg",
  "name_fr": "Candizole 200 mg",
  "name_nl": "Candizole 200 mg",
  "amp_code": "SAM281513-00",
  "strengths": [
    "200.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Fluconazole"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Fluconazole",
  "authorisation_numbers": [
    "BE281513"
  ]
}

See everything about fluconazole.

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.