Germany· DE-A57-db2262146fdd785a
Nizoral ®
A ketoconazole product containing ketoconazole, registered in Germany by Stada Gmbh. The same ATC class is registered in 14 of our 19 countries.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
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: Germany, from EMA Article 57 (European Union)
- 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
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Ketoconazole
- Manufacturer
- Stada Gmbh
- Country
- Germany (DE)
- ATC code
- D01AC08
- ATC class
- Ketoconazole
- Defined daily dose
- 30 mg, T
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- August 5, 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
Ketoconazole in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United States1% ketoconazoleTAGRID LLC
- United KingdomBoots Anti-Dandruff 2% shampooThe Boots Company Plc
- PolandKetoconazole HRAHRA Pharma Rare Diseases
- FranceKETOCONAZOLE ARROW 2 %, gel en récipient-unidoseARROW GENERIQUES
- SpainFUNGAREST 20 mg/g cremaLaboratorio Stada S.L.
- FinlandCanizol vetDechra Regulatory B.V.
- SwitzerlandKeto-med Shampoo
- NetherlandsKetoconazol Aurobindo Shampoo 20 mg/g, shampooAurobindo Pharma B.V.
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Fungoral, Nizoral
- Belgium · Nizoral
- Bulgaria · Ketoderm, Nizoral
- Cyprus · Ilgem Med, Nizoral
- Czechia · Ketokonazol Dr.Max, Nizoral
- 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 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/21e3b8ae-b863-4303-a01a-907df23dc3fe GET /v1/drugs/21e3b8ae-b863-4303-a01a-907df23dc3fe?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": "Ketoconazole",
"atc_from_source": null,
"authorisation_country": "Germany"
}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.