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Belgium· BE-AMP-SAM180564-00

Acatar 15 mg/5 ml - 50 mg/5 ml

A opium-derivate und expektoranzien product containing dextromethorphan hydrobromide, registered in Belgium by Laboratoires S.M.B.. The same ATC class is registered in 5 of our 19 countries.

ATC R05FA02

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedAcatar 15 mg/5 ml - 50 mg/5 mlATCR05FA02REGISTER NO.BE-AMP-SAM180564-00PACKS LISTED1CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about dextromethorphan hydrobromideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Opium-derivate und expektoranzien is registered in 5 of 19 countries.

Countries holding a registration under ATC R05FA02 (opium-derivate und expektoranzien), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 4 of them publish a price we can compare per daily dose
Search opium-derivate und expektoranzien products by name

Opium-derivate und expektoranzien · ATC R05FA02

5 / 19 countries

  • Belgiumprice
  • Canada
  • Finlandprice
  • Norwayprice
  • 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
Dextromethorphan Hydrobromide
Manufacturer
Laboratoires S.M.B.
Country
Belgium (BE)
ATC code
R05FA02
ATC class
Opium-Derivate und Expektoranzien
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    1275460

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Opium-derivate und expektoranzien in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All opium-derivate und expektoranzien products

Authorised across Europe · EMA

The same active substance is authorised in 23 EEA countries. Names it is sold under:

  • Austria · Easybronchial Stop Forte, Easybronchial Stop Junior
  • Bulgaria · Демефан, Динарекс
  • Cyprus · Diacol, Medorphan
  • Czechia · Dextromethorphan Nutra Essential, Robitussin Antitussicum Na Suchý Dráždivý Kašel
  • Germany · Dextro, Hustenstiller
  • Denmark · Dexofan
  • Estonia · Dinarex
  • Spain · Bicasan, Bisolvon Antitusivo
  • Finland · Resilar, Rometor
  • France · Biocadextro Adultes Sans Sucre, Dextromethorphane Sans Sucre, Édulcorée Au Maltitol Liquide Et À La Saccharine Sodique Biogaran
  • United Kingdom (Northern Ireland) · Asda Strong Dry Tickly Cough, Bell's Healthcare Dual Action Dry Cough
  • Hungary · Meddex Méz Ízű, Rhinathiol Köhögéscsillapító Felnőtteknek
  • Ireland · Benylin Non-Drowsy Dry Coughs, Robitussin Dry Cough
  • Iceland · Dexól, Dinarex
  • Italy · Aricodiltosse, Bechilar
  • Luxembourg · Acatar Mono, Bisolvon Toux Sèche
  • Latvia · Dinarex
  • Malta · Benylin Non-Drowsy Dry Coughs, Diacol
  • Netherlands · Daro Retard, Tussipect
  • Poland · Acodin, Inovox Na Kaszel Smak Miodowo-Cytrynowy
  • Portugal · Benflux Tosse Seca, Bisoltussin
  • Romania · Robitussin Antitussicum Pentru Tuse Uscată, Robitussin Junior Pentru Tuse Uscată
  • Slovakia · Dextromethorphan Nutra Essential, Dinarex

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/355fc4bd-4540-4de8-b286-890c63a09ecf
GET /v1/drugs/355fc4bd-4540-4de8-b286-890c63a09ecf?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": "Syrup",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Acatar 15 mg/5 ml - 50 mg/5 ml",
  "name_fr": "Acatar 15 mg/5 ml - 50 mg/5 ml",
  "name_nl": "Acatar 15 mg/5 ml - 50 mg/5 ml",
  "amp_code": "SAM180564-00",
  "strengths": [
    "3.0000",
    "3.0000",
    "10.0000",
    "10.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Dextromethorphan Hydrobromide",
    "Guaifenesin"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Opium Derivatives and Expectorants",
  "authorisation_numbers": [
    "BE180564"
  ]
}
API referenceMCP serverPlans

See everything about opium-derivate und expektoranzien.

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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