Belgium· BE-AMP-SAM152241-00

Praxilene 200 mg

A naftidrofuryl product containing naftidrofuryl oxalate, registered in Belgium by Merck. The same ATC class is registered in 3 of our 19 countries.

ATC C04AX21

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedPraxilene 200 mgATCC04AX21REGISTER NO.BE-AMP-SAM152241-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Naftidrofuryl is registered in 3 of 19 countries.

Countries holding a registration under ATC C04AX21 (naftidrofuryl), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 2 of them publish a price we can compare per daily dose

Naftidrofuryl · ATC C04AX21

3 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • United Kingdom
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
Naftidrofuryl Oxalate
Manufacturer
Merck
Country
Belgium (BE)
ATC code
C04AX21
ATC class
Naftidrofuryl
Defined daily dose
0.6 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    3412111
  • be_apb
    3412095

Regulatory notes

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

Same medicine, other countries

Naftidrofuryl in 1 other country

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

All naftidrofuryl products

Authorised across Europe · EMA

The same active substance is authorised in 8 EEA countries. Names it is sold under:

  • Bulgaria · Дузофарм
  • Cyprus · Clarantin
  • Czechia · Enelbin
  • Estonia · Enelbin Retard
  • France · Naftidrofuryl Benta, Naftidrofuryl Zentiva
  • United Kingdom (Northern Ireland) · Naftidrofuryl Noumed Life Sciences
  • Latvia · Enelbin Retard
  • Slovakia · Enelbin

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/ca683997-ef42-496e-8386-455a2b3540be
GET /v1/drugs/ca683997-ef42-496e-8386-455a2b3540be?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": "Prolonged-release tablet",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Praxilene 200 mg",
  "name_fr": "Praxilene 200 mg",
  "name_nl": "Praxilene 200 mg",
  "amp_code": "SAM152241-00",
  "strengths": [
    "200.0000",
    "200.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Naftidrofuryl Oxalate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Naftidrofuryl",
  "authorisation_numbers": [
    "BE152241"
  ]
}

See everything about naftidrofuryl.

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.