Drug Database
Back to search

Ireland· IE-PA-EU/1/99/118/001

Arava 10 mg Film-coated tablet

A leflunomid product containing leflunomide, registered in Ireland by Sanofi-Aventis Deutschland GmbH. The same ATC class is registered in 4 of our 19 countries.

ATC L04AA13

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedArava 10 mg Film-coated tabletATCL04AA13REGISTER NO.IE-PA-EU/1/99/118/001PACKS LISTED1CHECKEDSeptember 28, 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: Ireland, from HPRA (Ireland)
  • 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

HPRA (Ireland)
Active substance
Leflunomide
Manufacturer
Sanofi-Aventis Deutschland GmbH
Country
Ireland (IE)
ATC code
L04AA13
ATC class
Leflunomid
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/99/118/001

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
  • Belgium · Leflunomid Sandoz, Leflunomide Ab
  • 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
  • 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 HPRA (Ireland). 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/bdad115e-85ef-4a93-a06a-b1b3b6cefaa9
GET /v1/drugs/bdad115e-85ef-4a93-a06a-b1b3b6cefaa9?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",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "L04AA",
    "L04AA13"
  ],
  "strength": null,
  "pa_number": "EU/1/99/118/001",
  "substances": [
    "Leflunomide"
  ],
  "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": null,
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
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