Belgium· BE-AMP-SAM051283-00
Fenistil 1 mg
A dimetindene product containing dimetindene maleate, registered in Belgium by Haleon Belgium. The same ATC class is registered in 6 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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 R06AB03 (dimetindene), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 5 of them publish a price we can compare per daily dose
Dimetindene · ATC R06AB03
6 / 19 countries
- Belgiumprice
- Czechiaprice
- Finlandprice
- Germany
- Polandprice
- Switzerlandprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Dimetindene Maleate
- Manufacturer
- Haleon Belgium
- Country
- Belgium (BE)
- ATC code
- R06AB03
- ATC class
- Dimetindene
- Defined daily dose
- 4 mg, O
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 1
- be_apb0112664
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.
- CzechiaBELDIMETBELUPO lijekovi i kozmetika, d.d., Koprivnica
- PolandAleric ŻelUS Pharmacia Sp. z o.o.
- SwitzerlandDimetindene Leman
- GermanyDimestilGrindeks
- SpainDERMAPIC 1 MG/G GELLaboratorios Normon S.A.
- IrelandPruridene 1 mg/g GelCitrine Healthcare Limited
- NorwayFenistilNovartis (2)
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Dimestil, 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
- 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 FAMHP / AFMPS (Belgium). 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/f112d8a1-c25d-4eb1-a57c-34ef3e1774cb GET /v1/drugs/f112d8a1-c25d-4eb1-a57c-34ef3e1774cb?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": "Coated tablet",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Fenistil 1 mg",
"name_fr": "Fenistil 1 mg",
"name_nl": "Fenistil 1 mg",
"amp_code": "SAM051283-00",
"strengths": [
"1.0000",
"1.0000",
"1.0000",
"43.7500",
"32.9510",
"2.0000"
],
"pack_count": 1,
"substances": [
"Dimetindene Maleate",
"Lactose",
"Sucrose",
"Wheat Starch"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Dimetindene",
"authorisation_numbers": [
"BE051283"
]
}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.