Ireland· IE-PA-PA2206/004/002
Zaditen 1 mg Tablets
A ketotifen product containing ketotifen fumarate, registered in Ireland by Alfasigma S.p.A. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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
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
The record
At a glance
HPRA (Ireland)- Active substance
- KETOTIFEN 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_numberPA2206/004/002
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
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.
- United KingdomZaditen 1mg tabletsCD Pharma Srl
- NorwayKetotifen wzfPolpharma
- CanadaZADITENTEVA CANADA LIMITED
- NetherlandsZaditen 1 mg, tablettenAlfasigma S.p.A.
- PolandKetotifen WZFZakłady Farmaceutyczne POLPHARMA S.A.
- United StatesAlawayBausch & Lomb Incorporated
- CzechiaKETOFHexal AG, Holzkirchen
- SpainBENTIFEN 0,25mg/ml COLIRIO EN SOLUCIONLaboratoires Thea
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/417e1205-211d-4bf3-a146-96ba3dfc5c9f GET /v1/drugs/417e1205-211d-4bf3-a146-96ba3dfc5c9f?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": [
"R06AX",
"R06AX17"
],
"strength": null,
"pa_number": "PA2206/004/002",
"substances": [
"KETOTIFEN FUMARATE"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "19/12/1979",
"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.