Ireland· IE-PA-EU/1/99/118/004
Arava 10 mg Film-coated tablet
A medicinal product containing leflunomide, registered in Ireland by Sanofi-Aventis Deutschland GmbH.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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_numberEU/1/99/118/004
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.
- CzechiaARAVASanofi-Aventis Deutschland GmbH, Frankfurt am Main
- SpainARAVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULASanofi-Aventis Deutschland Gmbh
- BelgiumArava 10 mgPI Pharma
- SwitzerlandArava
- United StatesAravasanofi-aventis U.S. LLC
- NetherlandsArava 10 mg, filmomhulde tablettenSanofi-Aventis Deutschland GmbH
- FinlandAravaSanofi-Aventis Deutschland GmbH
- FranceARAVA 10 mg, comprimé pelliculéSANOFI AVENTIS (ALLEMAGNE)
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/2875960c-5b21-41dd-b9f9-ebe706db92cd GET /v1/drugs/2875960c-5b21-41dd-b9f9-ebe706db92cd?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/1/99/118/004",
"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
}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.