Ireland· IE-PA-EU/1/99/118/007

Arava 20 mg Film-coated tablet

A medicinal product containing leflunomide, registered in Ireland by Sanofi-Aventis Deutschland GmbH.

Checked against HPRA (Ireland) on September 28, 2026

Informational only — not a medical device.

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The record

At a glance

HPRA (Ireland)

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

Packs & prices · 1

ie_pa_number
EU/1/99/118/007

Regulatory notes

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

Same medicine, other countries

Leflunomide in 16 other countries

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

All leflunomide 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/0e68ab93-56aa-4d5b-acb0-bbe9520699c3
GET /v1/drugs/0e68ab93-56aa-4d5b-acb0-bbe9520699c3?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": null,
  "strength": null,
  "pa_number": "EU/1/99/118/007",
  "substances": [
    "Leflunomide"
  ],
  "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "02/09/1999",
  "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 reference MCP server Plans

See everything about leflunomide.

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.

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