Poland· PL-100440411
Fenistil
A dimetindene product containing dimetindeni maleas, registered in Poland by PharmaVitae Sp. z o.o. sp. k.. The same ATC class is registered in 6 of our 19 countries.
Checked against URPL (Poland) 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: Poland, from URPL (Poland)
- 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
URPL (Poland)- Active substance
- Dimetindeni maleas
- Manufacturer
- PharmaVitae Sp. z o.o. sp. k.
- Country
- Poland (PL)
- ATC code
- D04AA13
- ATC class
- Dimetindene
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin05909991437855
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.
- SwitzerlandDimetindene Leman 1 mg/g, gelLeman SKL SA
- SpainDERMAPIC 1 MG/G GELLaboratorios Normon S.A.
- IrelandPruridene 1 mg/g GelCitrine Healthcare Limited
- 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
- Ireland · Pruridene
- Italy · Dimetindene Alkaloid-Int, Fenistil
- Lithuania · Fenistil, Frest
- Luxembourg · Fenistil, Fenistil Dragees
- Latvia · Dimestil, Fenistil
- Malta · Fenistil
- 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 URPL (Poland). 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/fbb6ea2c-179e-4448-a01b-e2e2a34e1b2d GET /v1/drugs/fbb6ea2c-179e-4448-a01b-e2e2a34e1b2d?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": "Żel",
"source": "urpl",
"strength": "1 mg/g",
"packaging": "05909991437855 ¦ OTC ¦ 137540\n1 tuba 30 g",
"substance": "Dimetindeni maleas 1 mg/g",
"common_name": "Dimetindeni maleas",
"pl_product_id": "100440411",
"pozwolenie_nr": "247/20",
"auth_procedure": "IR",
"authorisation_validity": "2025-09-24"
}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.