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Belgium· BE-AMP-SAM385944-00

Leflunomide Apotex 10 mg

A leflunomid product containing leflunomide, registered in Belgium by Apotex Europe. 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)normalisedLeflunomide Apotex 10 mgATCL04AA13REGISTER NO.BE-AMP-SAM385944-00PACKS LISTED0CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about leflunomideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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
Search leflunomid products by name

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
Apotex Europe
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 · 0

No packs listed by the register for this record.

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
Check leflunomid against other medicinesHow interaction checks work

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/e5a6e94b-9f33-4b6b-a161-5532eee2fa83
GET /v1/drugs/e5a6e94b-9f33-4b6b-a161-5532eee2fa83?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": "Tablet",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Leflunomide Apotex 10 mg",
  "name_fr": "Leflunomide Apotex 10 mg",
  "name_nl": "Leflunomide Apotex 10 mg",
  "amp_code": "SAM385944-00",
  "strengths": [
    "10.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Leflunomide"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Leflunomide",
  "authorisation_numbers": [
    "BE385944"
  ]
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console