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Belgium· BE-AMP-SAM002073-00

Hexomedine 1 mg/g - 0.5 mg/g

A hexamidine product containing tetracaine hydrochloride, registered in Belgium by Melisana.

ATC R02AA18

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedHexomedine 1 mg/g - 0.5 mg/gATCR02AA18REGISTER NO.BE-AMP-SAM002073-00PACKS LISTED1CHECKEDSeptember 26, 2026

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Tetracaine Hydrochloride
Manufacturer
Melisana
Country
Belgium (BE)
ATC code
R02AA18
ATC class
Hexamidine
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    0115063

Regulatory notes

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

Same medicine, other countries

Hexamidine in 12 other countries

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

All hexamidine products

Authorised across Europe · EMA

The same active substance is authorised in 10 EEA countries. Names it is sold under:

  • Germany · Tetracain-Hcl Smartpractice Europe
  • Spain · Lubristesic, Tetracaína Lainco
  • France · Tetracaine Thea
  • United Kingdom (Northern Ireland) · Ametop, Anethaine
  • Greece · Tetracaine Hydrochloride Cooper
  • Ireland · Ametop, Minims
  • Luxembourg · Minims, Minims Tetracaine Chlorhydrate Bausch + Lomb Ireland Limited
  • Netherlands · Minims Tetracainehydrochloride, Tetracaïnehydrochloride Minims Bausch + Lomb Ireland
  • Norway · Tetrakain Minims Bausch + Lomb Ireland Limited
  • Sweden · Tetrakain Bausch & Lomb

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/a26b1414-17eb-40a5-9db0-5c73657904ea
GET /v1/drugs/a26b1414-17eb-40a5-9db0-5c73657904ea?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": "Hexomedine 1 mg/g - 0.5 mg/g",
  "name_fr": "Hexomedine 1 mg/g - 0.5 mg/g",
  "name_nl": "Hexomedine 1 mg/g - 0.5 mg/g",
  "amp_code": "SAM002073-00",
  "strengths": [
    "0.0150",
    "0.0150",
    "0.0300",
    "0.0300",
    "0.0198",
    "7.5000",
    "0.0150",
    "4.8210"
  ],
  "pack_count": 1,
  "substances": [
    "Tetracaine Hydrochloride",
    "Hexamidine Diisetionate",
    "Ethanol",
    "Glycerol",
    "Sodium Acetate",
    "Sucrose"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Hexamidine",
  "authorisation_numbers": [
    "BE002073"
  ]
}

See everything about hexamidine.

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.