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Ireland· IE-PA-PA2206/004/001

Zaditen 1mg/5ml oral solution

A ketotifen product containing ketotifen hydrogen fumarate, registered in Ireland by Alfasigma S.p.A. The same ATC class is registered in 11 of our 19 countries.

ATC R06AX17

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedZaditen 1mg/5ml oral solutionATCR06AX17REGISTER NO.IE-PA-PA2206/004/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Ketotifen is registered in 11 of 19 countries.

Countries holding a registration under ATC R06AX17 (ketotifen), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 6 of them publish a price we can compare per daily dose

Ketotifen · ATC R06AX17

11 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
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.

Price per daily dose

What a daily dose of ketotifen costs, country by country.

Normalised to the WHO defined daily dose (2 mg), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Ketotifen · price per daily dose (2 mg)

USD · FX 28 Sept 2026

  • IT Italy$0.20
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

HPRA (Ireland)
Active substance
Ketotifen hydrogen fumarate
Manufacturer
Alfasigma S.p.A
Country
Ireland (IE)
ATC code
R06AX17
ATC class
Ketotifen
Defined daily dose
2 mg, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA2206/004/001

Regulatory notes

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

Interactions

108 interactions on record for ketotifen.

Graded by severity as the source publishes them — 108 info. 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

Ketotifen · interactions on record

108 records

Interaction register. Grades as the source publishes them.

Same medicine, other countries

Ketotifen in 16 other countries

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

All ketotifen products

Authorised across Europe · EMA

The same active substance is authorised in 24 EEA countries. Names it is sold under:

  • Austria · Ketotifen Stulln, Ketotifen Stulln 0,25 Mg/Ml Augentropfen Pharma Stulln
  • Belgium · Altriabak, Ketazed
  • Bulgaria · Ketotifen Sopharma, Забак
  • Cyprus · Meni-Drops, Tenerel
  • Czechia · Ketof, Ketotifen Al
  • Germany · Allergo-Vision Sine, Ketazed
  • Denmark · Ketazed, Zaditen
  • Spain · Bentifen, Ketisal
  • Finland · Ketazed, Ketotifen Stulln 0,25 Mg/Ml Silmätipat, Liuos
  • France · Ketazed, Monoketo
  • United Kingdom (Northern Ireland) · Ketazed, Ketofall
  • Greece · Cleroptic, K-Drops
  • Iceland · Zaditen
  • Italy · Brunistill, Chetotifene Mylan Generics
  • Luxembourg · Altriabak, Ketazed
  • Latvia · Ketotifen
  • Netherlands · Altriabak, Ketazed
  • Norway · Ketazed, Zaditen
  • Poland · Ketotifen Hasco, Ketotifen Stulln
  • Portugal · Lidina, Lidinafree
  • Romania · Ketazed, Ketof
  • Sweden · Bentifen, Ketazed
  • Slovenia · Zaditen, Zaditen Sdu
  • Slovakia · Denerel, Zaditen

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/3ffb1bb6-adb5-4ec8-860d-609c15cf9909
GET /v1/drugs/3ffb1bb6-adb5-4ec8-860d-609c15cf9909?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": "Oral solution",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "R06AX",
    "R06AX17"
  ],
  "strength": null,
  "pa_number": "PA2206/004/001",
  "substances": [
    "Ketotifen hydrogen fumarate"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "30/11/1979",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about ketotifen.

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.