Belgium· BE-AMP-SAM140113-00

Nizoral 20 mg/g

A ketoconazole product containing ketoconazole, registered in Belgium by EG. The same ATC class is registered in 14 of our 19 countries.

ATC D01AC08

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedNizoral 20 mg/gATCD01AC08REGISTER NO.BE-AMP-SAM140113-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Ketoconazole is registered in 14 of 19 countries.

Countries holding a registration under ATC D01AC08 (ketoconazole), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 8 of them publish a price we can compare per daily dose

Ketoconazole · ATC D01AC08

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Ketoconazole
Manufacturer
EG
Country
Belgium (BE)
ATC code
D01AC08
ATC class
Ketoconazole
Defined daily dose
30 mg, T
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    0091090
  • be_apb
    4966271

Regulatory notes

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

Same medicine, other countries

Ketoconazole in 16 other countries

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

All ketoconazole products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Fungoral, Nizoral
  • Bulgaria · Ketoderm, Nizoral
  • Cyprus · Ilgem Med, Nizoral
  • Czechia · Ketokonazol Dr.Max, Nizoral
  • Germany · Ketoconazol Klinge, Ketozolin
  • Denmark · Ketoconazole Actavis, Nizoral
  • Estonia · Ketoconazol Ratiopharm, Mikanisal
  • Spain · Fungarest, Keto-Cure
  • Finland · Ketoconazol Ratiopharm, Ketoconazole Stada
  • France · Kapanek, Ketoconazole Arrow
  • United Kingdom (Northern Ireland) · Daktarin Gold, Daktarin Intensiv
  • Greece · Botaderm, Ebersept
  • Croatia · Oronazol
  • Hungary · Nizoral, Nizoral Korpásodás Ellen
  • Ireland · Ketoconazole Pinewood Laboratories, Nizoral
  • Iceland · Dermatín, Fungoral
  • Italy · Ketonova, Nizoblue
  • Liechtenstein · Ketoconazole Esteve
  • Lithuania · Ketoconazol Ratiopharm, Nizoral
  • Luxembourg · Nizoral
  • Latvia · Ketoconazol Ratiopharm, Mikanisal
  • Malta · Nizoral
  • Netherlands · Ketoconazol Cf, Ketoconazol Double-E Pharma
  • Norway · Fungoral, Ketoconazole Esteve
  • Poland · Ketoconazole Hasco, Nizax Activ
  • Portugal · Cetoconazol Folicalm, Nizoral
  • Romania · Ketoconazol Dr. Max, Ketoconazol Dr.Max
  • Sweden · Fungoral, Ketoconazol Actavis
  • Slovenia · Oronazol
  • Slovakia · Ketoconazol Dr. Max, Nizoral

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/df50ef53-ef7e-4b80-80cc-9f7eb18c6dc1
GET /v1/drugs/df50ef53-ef7e-4b80-80cc-9f7eb18c6dc1?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": "Shampoo",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Nizoral 20 mg/g",
  "name_fr": "Nizoral 20 mg/g",
  "name_nl": "Nizoral 20 mg/g",
  "amp_code": "SAM140113-00",
  "strengths": [
    "20.0000",
    "20.0000",
    "150.0000",
    "5.0000",
    "1.0000",
    "380.0000"
  ],
  "pack_count": 4,
  "substances": [
    "Ketoconazole",
    "Disodium Laureth Sulfosuccinate",
    "Sodium Chloride",
    "Sodium Hydroxide",
    "Sodium Lauryl Ether Sulfate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Ketoconazole",
  "authorisation_numbers": [
    "BE140113"
  ]
}

See everything about ketoconazole.

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.