Ireland· IE-PA-EU/1/14/965/001
Ketoconazole Esteve 200 mg tablets
A ketoconazole product containing ketoconazole, registered in Ireland by Esteve Pharmaceuticals S.A.. The same ATC class is registered in 7 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Ketoconazole is registered in 7 of 19 countries.
Countries holding a registration under ATC J02AB02 (ketoconazole), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 3 of them publish a price we can compare per daily dose
Ketoconazole · ATC J02AB02
7 / 19 countries
- Canada
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Ketoconazole
- Manufacturer
- Esteve Pharmaceuticals S.A.
- Country
- Ireland (IE)
- ATC code
- J02AB02
- ATC class
- Ketoconazole
- Defined daily dose
- 0.2 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/14/965/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
855 interactions on record for ketoconazole.
Graded by severity as the source publishes them — 279 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
Ketoconazole · interactions on record
855 records
- 279 severe
- 395 moderate
- 44 minor
- 100 info
Most severe, free to view
- PapaverineA03AD01severe
- CisaprideA03FA02severe
- DolasetronA04AA04severe
- NaloxegolA06AH03severe
37 more interactions 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
Ketoconazole in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesKetoconazoleDirect_Rx
- United KingdomKetoconazole 200mg tabletsEsteve Pharmaceuticals Ltd
- FinlandCanizol vetDechra Regulatory B.V.
- CanadaAPO-KETOCONAZOLEAPOTEX INC
- PolandKetoconazole HRAHRA Pharma Rare Diseases
- IcelandKetoconazole EsteveEsteve Pharmaceuticals S.A.
- NetherlandsKetoconazole Esteve, 200 mg tablettenEsteve Pharmaceuticals S.A.
- NorwayKetoconazole EsteveEsteve Pharmaceuticals S.A
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
- 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
- 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 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/192517e7-0975-40c4-b02d-ceabc9db6e4e GET /v1/drugs/192517e7-0975-40c4-b02d-ceabc9db6e4e?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": "Tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"J02AB",
"J02AB02"
],
"strength": null,
"pa_number": "EU/1/14/965/001",
"substances": [
"Ketoconazole"
],
"legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": null,
"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 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.