Belgium· BE-AMP-SAM415947-00

Biofenac 100 mg

A aceclofenac product containing aceclofenac, registered in Belgium by Impexeco. The same ATC class is registered in 10 of our 19 countries.

ATC M01AB16

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedBiofenac 100 mgATCM01AB16REGISTER NO.BE-AMP-SAM415947-00PACKS LISTED3CHECKEDSeptember 26, 2026

Where it is registered

Aceclofenac is registered in 10 of 19 countries.

Countries holding a registration under ATC M01AB16 (aceclofenac), each read from that country’s own register.

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

Aceclofenac · ATC M01AB16

10 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Finlandprice
  • Germany
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • 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.

Price per daily dose

What a daily dose of aceclofenac costs, country by country.

Normalised to the WHO defined daily dose (0.2 g), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Aceclofenac · price per daily dose (0.2 g)

USD · FX 28 Sept 2026

  • IT Italy$0.32
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Aceclofenac
Manufacturer
Impexeco
Country
Belgium (BE)
ATC code
M01AB16
ATC class
Aceclofenac
Defined daily dose
0.2 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 3

  • be_apb
    2990810
  • be_apb
    7700743
  • be_apb
    2990802

Regulatory notes

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

Same medicine, other countries

Aceclofenac in 12 other countries

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

All aceclofenac products

Authorised across Europe · EMA

The same active substance is authorised in 21 EEA countries. Names it is sold under:

  • Bulgaria · Aflamil, Алкинак
  • Cyprus · Aceclonac, Airtal
  • Czechia · Aceclofenac Avmc, Biofenac
  • Germany · Beofenac
  • Estonia · Betiral
  • Spain · Aceclofenaco Cinfa, Aceclofenaco Kern Pharma
  • France · Aceclofenac Biogaran, Aceclofenac Eg Labo
  • United Kingdom (Northern Ireland) · Aceclofenac Accord Healthcare, Aceclofenac Rivopharm Uk
  • Greece · Aceclonac, Arlina
  • Hungary · Aceclofenac Zentiva, Aflamin
  • Ireland · Vitafen
  • Italy · Aceclofenac Accord, Aceclofenac Eg
  • Lithuania · Aceclofenac Orion, Aceclofenac Rivopharm
  • Luxembourg · Aceclofenac Eg, Air-Tal
  • Latvia · Aceclofenac Rivopharm, Airtal
  • Netherlands · Aceclofenac Double-E Pharma, Biofenac
  • Poland · Aceclofenac Holsten, Aceklik
  • Portugal · Aceclofenac Alter, Aceclofenac Generis
  • Romania · Aflamil
  • Sweden · Barcan
  • Slovakia · Aceclofenac Accord, Aflamil

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/adb80a9d-cae3-44ee-98e1-5ec15369cfb1
GET /v1/drugs/adb80a9d-cae3-44ee-98e1-5ec15369cfb1?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": "Film-coated tablet",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Biofenac 100 mg",
  "name_fr": "Biofenac 100 mg",
  "name_nl": "Biofenac 100 mg",
  "amp_code": "SAM415947-00",
  "strengths": [
    "100.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Aceclofenac"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Aceclofenac",
  "authorisation_numbers": [
    "1549PI0097F003"
  ]
}

See everything about aceclofenac.

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.