Belgium· BE-AMP-SAM250171-00

Bisolangin 20 mg

A anesthetics, local product containing ambroxol hydrochloride, registered in Belgium by Opella Healthcare Belgium.

ATC R02AD

Checked against FAMHP / AFMPS (Belgium) on September 26, 2026

Informational only — not a medical device.

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The record

At a glance

FAMHP / AFMPS (Belgium)

Active substance: Ambroxol Hydrochloride
Manufacturer: Opella Healthcare Belgium
Country: Belgium (BE)
ATC code: R02AD
ATC class: Anesthetics, local
Reimbursed: Not published by this register
Source register: FAMHP / AFMPS (Belgium)
Last checked: September 26, 2026

Packs & prices · 0

No packs listed by the register for this record.

Regulatory notes

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

Same medicine, other countries

Ambroxol hydrochloride in 11 other countries

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

All ambroxol hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 26 EEA countries. Names it is sold under:

Austria · Ambrobene, Ambrohexal
Bulgaria · Mукосолван Макс, Амбрекс
Cyprus · Broxivan, Fluibron
Czechia · Ambrobene, Ambrosan
Germany · Ambrobeta, Ambrox
Denmark · Ambroxolhydrochlorid Teva
Estonia · Ambrolan, Ambrolytin
Spain · Ambroxol Aldo-Unión, Ambroxol Cinfa
Finland · Ambroxol Ratiopharm, Flavamed
France · Ambroxol Arrow, Ambroxol Biogaran Conseil
Greece · Abrobion, Aprinol
Croatia · Brosils, Flavamed
Hungary · Ambrobene, Ambrobene Liquid
Iceland · Broksil
Italy · Ambrotus, Ambroxol Tecnigen
Lithuania · Ambrolan, Ambrotusin
Luxembourg · Ambroxol Hustenlöser Ratiopharm, Ambroxol Hustensaft
Latvia · Ambroksol, Ambrolan
Malta · Broncoliber, Broncosil
Norway · Ambroksolhydroklorid Med Lakrissmak Geiser, Ambroksolhydroklorid Med Mintsmak Geiser
Poland · Aflegan, Ambroksol Apteo Med
Portugal · Ambroxol Azevedos, Ambroxol Farmoz
Romania · Ambromed, Ambroxol Al
Sweden · Ambroksol Lakrits Geiser, Ambroksol Mint Geiser
Slovenia · Ambroksolijev Klorid Berlin-Chemie, Ambrospray
Slovakia · Ambrobene, Ambrobene Retard

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/18e88f84-1413-4ae7-a5bd-a6fd59bf8469
GET /v1/drugs/18e88f84-1413-4ae7-a5bd-a6fd59bf8469?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": "Lozenge",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Bisolangin 20 mg",
  "name_fr": "Bisolangin 20 mg",
  "name_nl": "Bisolangin 20 mg",
  "amp_code": "SAM250171-00",
  "strengths": [
    "20.0000",
    "0.5000",
    "1373.5000"
  ],
  "pack_count": 15,
  "substances": [
    "Ambroxol Hydrochloride",
    "Saccharin Sodium",
    "Sorbitol"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Anesthetics, Local",
  "authorisation_numbers": [
    "BE250171"
  ]
}

API reference MCP server Plans

See everything about ambroxol hydrochloride.

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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