Belgium· BE-AMP-SAM480426-00

Arava 20 mg

A leflunomid product containing leflunomide, registered in Belgium by PI Pharma. The same ATC class is registered in 4 of our 19 countries.

ATC L04AA13

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedArava 20 mgATCL04AA13REGISTER NO.BE-AMP-SAM480426-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Leflunomid is registered in 4 of 19 countries.

Countries holding a registration under ATC L04AA13 (leflunomid), each read from that country’s own register.

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

Leflunomid · ATC L04AA13

4 / 19 countries

  • Belgiumprice
  • Ireland
  • Polandprice
  • Switzerlandprice
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
Leflunomide
Manufacturer
PI Pharma
Country
Belgium (BE)
ATC code
L04AA13
ATC class
Leflunomid
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

1 priced
  • be_apb
    3270063
    EUR 90.41
  • be_apb
    7716640

Regulatory notes

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

Interactions

805 interactions on record for leflunomid.

Graded by severity as the source publishes them — 537 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Leflunomid · interactions on record

805 records

  • 537 severe
  • 47 moderate
  • 7 minor
  • 214 info

Most severe, free to view

  • ClotrimazoleA01AB18severe
  • Chenodeoxycholic acidA05AA01severe
  • PrednisoloneA07EA01severe
  • HydrocortisoneA07EA02severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Leflunomid in 16 other countries

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

All leflunomid products

Authorised across Europe · EMA

The same active substance is authorised in 26 EEA countries. Names it is sold under:

  • Austria · Leflunomid Stada
  • Bulgaria · Багеда
  • Cyprus · Arotan
  • Czechia · Leflon, Leflugen
  • Germany · Leflon, Leflunomid 1 A Pharma
  • Denmark · Leflunomid, Leflunomid "egis"
  • Estonia · Leflunomide Elvim
  • Spain · Lefluartil, Leflunomida Aurovitas
  • Finland · Leflunomide Orion, Leflunomide Stada
  • France · Leflunomide Arrow, Leflunomide Biogaran
  • United Kingdom (Northern Ireland) · Leflunomide Aspire Pharma, Leflunomide Milpharm
  • Greece · Lefid, Lefluonia
  • Hungary · Leflunomid Sandoz
  • Ireland · Leflunomide Aspire Pharma (Malta)
  • Iceland · Arava, Leflunomide Medac
  • Italy · Leflunomide Aurobindo, Leflunomide Mylan
  • Liechtenstein · Arava, Leflunomide Medac
  • Lithuania · Leflunomide Elvim, Leflunomide Sandoz
  • Latvia · Leflunomide Elvim, Leflunomide Sandoz
  • Malta · Leflunomide Normon
  • Netherlands · Leflunomide Aurobindo, Leflunomide Cf
  • Norway · Arava, Leflunomide Medac
  • Poland · Leflunomid Bluefish, Leflunomid Egis
  • Portugal · Leflunomida Farmoz, Leflunomida Generis
  • Romania · Leflon, Leflunomidă Arena
  • Sweden · Leflunomid Bluefish

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/f1cb39d4-de41-4945-8b42-e95f1ca15988
GET /v1/drugs/f1cb39d4-de41-4945-8b42-e95f1ca15988?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": "Arava 20 mg",
  "name_fr": "Arava 20 mg",
  "name_nl": "Arava 20 mg",
  "amp_code": "SAM480426-00",
  "strengths": [
    "20.0000",
    "20.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Leflunomide"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Leflunomide",
  "authorisation_numbers": [
    "1637PI0382F003"
  ]
}

See everything about leflunomid.

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.