Ireland· IE-PA-PA23214/002/001
Pruridene 1 mg/g Gel
A dimetindene product containing dimetindene maleate, registered in Ireland by Citrine Healthcare Limited. The same ATC class is registered in 6 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Dimetindene is registered in 6 of 19 countries.
Countries holding a registration under ATC D04AA13 (dimetindene), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 4 of them publish a price we can compare per daily dose
Dimetindene · ATC D04AA13
6 / 19 countries
- Czechiaprice
- Germany
- Ireland
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Dimetindene maleate
- Manufacturer
- Citrine Healthcare Limited
- Country
- Ireland (IE)
- ATC code
- D04AA13
- ATC class
- Dimetindene
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA23214/002/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dimetindene in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandAleric ŻelUS Pharmacia Sp. z o.o.
- SwitzerlandDimetindene Leman 1 mg/g, gelLeman SKL SA
- SpainDERMAPIC 1 MG/G GELLaboratorios Normon S.A.
- CzechiaBELDIMETBELUPO lijekovi i kozmetika, d.d., Koprivnica
- GermanyDimestilGrindeks
- BelgiumFenistil 0.1 %Haleon Belgium
- NorwayFenistilNovartis (2)
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Dimestil, Fenistil
- Belgium · Fenistil
- Bulgaria · Диместил, Полеспот
- Cyprus · Fenedim, Fenistil
- Czechia · Beldimet, Dimalen
- Germany · Dimestil, Dimetin Adgc
- Estonia · Dimestil
- Spain · Dermapic, Dimestil
- Greece · Chingor, Dimestil
- Croatia · Belodin A Derm, Dimetindenmaleat Grindeks
- Hungary · Dimestil, Fenistil
- Italy · Dimetindene Alkaloid-Int, Fenistil
- Lithuania · Fenistil, Frest
- Luxembourg · Fenistil, Fenistil Dragees
- Latvia · Dimestil, Fenistil
- Malta · Fenistil
- Poland · Aleric Żel, Allertec Foxill
- Portugal · Balpic, Dimetindeno Benadermapic
- Romania · Calemo, Fenistil
- Slovenia · Fenistil, Flenty
- Slovakia · Fenimax, Fenistil
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/e64bbd34-cc45-4ed4-992d-a91b04971dfb GET /v1/drugs/e64bbd34-cc45-4ed4-992d-a91b04971dfb?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": "Gel",
"routes": [
"Cutaneous use"
],
"source": "hpra",
"atc_all": [
"D04AA13"
],
"strength": null,
"pa_number": "PA23214/002/001",
"substances": [
"Dimetindene maleate"
],
"legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "16/08/2024",
"dispensing_status": "Product not subject to medical prescription",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about dimetindene.
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.