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Belgium· BE-AMP-SAM449351-00

Ambroxine 2,5 mg/dose

A anesthetics, local product containing ambroxol hydrochloride, registered in Belgium by Boehringer Ingelheim.

ATC R02AD

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedAmbroxine 2,5 mg/doseATCR02ADREGISTER NO.BE-AMP-SAM449351-00PACKS LISTED0CHECKEDSeptember 26, 2026

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Ambroxol Hydrochloride
Manufacturer
Boehringer Ingelheim
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/3cc2ab90-9e0d-41e0-8e8b-923211889e1c
GET /v1/drugs/3cc2ab90-9e0d-41e0-8e8b-923211889e1c?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": "Oromucosal spray, solution",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Ambroxine 2,5 mg/dose",
  "name_fr": "Ambroxine 2,5 mg/dose",
  "name_nl": "Ambroxine 2,5 mg/dose",
  "amp_code": "SAM449351-00",
  "strengths": [
    "2.6000"
  ],
  "pack_count": 2,
  "substances": [
    "Ambroxol Hydrochloride"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Anesthetics, Local",
  "authorisation_numbers": [
    "BE449351"
  ]
}

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.