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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.

ATC J02AB02

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedKetoconazole Esteve 200 mg tabletsATCJ02AB02REGISTER NO.IE-PA-EU/1/14/965/001PACKS LISTED1CHECKEDSeptember 28, 2026

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
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

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_number
    EU/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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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
  • 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.