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Belgium· BE-AMP-SAM051563-00

Fenistil 0.1 %

A dimetindene product containing dimetindene maleate, registered in Belgium by Haleon Belgium. The same ATC class is registered in 6 of our 19 countries.

ATC R06AB03

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedFenistil 0.1 %ATCR06AB03REGISTER NO.BE-AMP-SAM051563-00PACKS LISTED1CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about dimetindene maleateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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
Search dimetindene products by name

Dimetindene · ATC R06AB03

6 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Finlandprice
  • Germany
  • Polandprice
  • Switzerlandprice
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.

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_apb
    2565950

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.

All dimetindene products

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/03d7abd7-62a6-4213-a18e-ed67fbe7be52
GET /v1/drugs/03d7abd7-62a6-4213-a18e-ed67fbe7be52?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 drops, solution",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Fenistil 0.1 %",
  "name_fr": "Fenistil 0.1 %",
  "name_nl": "Fenistil 0.1 %",
  "amp_code": "SAM051563-00",
  "strengths": [
    "1.0000",
    "1.0000",
    "1.0000",
    "1.0000",
    "1.0000",
    "16.0000",
    "100.0000",
    "0.5000"
  ],
  "pack_count": 1,
  "substances": [
    "Dimetindene Maleate",
    "Benzoic Acid",
    "Disodium Edetate",
    "Disodium Hydrogen Phosphate Dodecahydrate",
    "Propylene Glycol",
    "Saccharin Sodium"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Dimetindene",
  "authorisation_numbers": [
    "BE051563"
  ]
}
API referenceMCP serverPlans

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.

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