Belgium· BE-AMP-SAM002396-00

Toplexil

A medicinal product containing oxomemazine, registered in Belgium by Melisana.

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedToplexilATC—REGISTER NO.BE-AMP-SAM002396-00PACKS LISTED1CHECKEDSeptember 26, 2026

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Oxomemazine
Manufacturer
Melisana
Country
Belgium (BE)
ATC code
—
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    0086769

Regulatory notes

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

Same medicine, other countries

Oxomemazine in 1 other country

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

All oxomemazine products

Authorised across Europe · EMA

The same active substance is authorised in 2 EEA countries. Names it is sold under:

  • Bulgaria · Булзин
  • France · Humex Toux Seche, Humex Toux Seche Sans Sucre, Édulcorée À L'acésulfame Potassique

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/a8e28c9c-d60c-43db-a11b-6ed5eb64f0a2
GET /v1/drugs/a8e28c9c-d60c-43db-a11b-6ed5eb64f0a2?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": "Toplexil",
  "name_fr": "Toplexil",
  "name_nl": "Toplexil",
  "amp_code": "SAM002396-00",
  "strengths": [
    "0.3300",
    "6.6600",
    "6.6600",
    "6.6600",
    "6.6600",
    "6.6600",
    "0.3300",
    "6.6600",
    "6.6600",
    "6.6600",
    "0.3300",
    "6.6600"
  ],
  "pack_count": 1,
  "substances": [
    "Oxomemazine",
    "Guaifenesin",
    "Paracetamol",
    "Sodium Benzoate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": null,
  "authorisation_numbers": [
    "0188S 0867F008"
  ]
}

See everything about oxomemazine.

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.