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Medicines
Spain
Leflunomide

AEMPS 2000

Leflunomide

ARAVA 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

100 mg comprimido recubierto con películaSpainAuthorisedAuthorised 9 Feb 2000

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

AravaBrazil · Sanofi Medley Farmacêutica Ltda.Same brand
AravaBrazil · Sanofi-Aventis Farmacêutica LtdaSame brand
AravaCanada · 10 MG · Tablet · Sanofi-Aventis Canada INCSame brand
AravaCanada · 20 MG · Tablet · Sanofi-Aventis Canada INCSame brand
AravaCanada · 100 MG · Tablet · Sanofi-Aventis Canada INCSame brand
AravaEuropean Union · Sanofi-aventis Deutschland GmbHSame brand
AravaCroatiaSame brand
AravaItaly · Compressa rivestita con film · Sanofi-Aventis Deutschland GMBHSame brand

More with the same substance on this register

ARAVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULALeflunomide · 10 mg · comprimido recubierto con películaSpain
Arava 10 MG Comprimidos Recubiertos con PeliculaLeflunomide · 10 mg · comprimido recubierto con película

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

🇳🇱Arava 10 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Sanofi-Aventis Deutschland GmbHSame brand

🇳🇱Arava 100 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Sanofi-Aventis Deutschland GmbHSame brand

🇳🇱Arava 20 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Sanofi-Aventis Deutschland GmbHSame brand

🇳🇿AravaNew Zealand · Tab 20 mgSame brand

🇳🇿AravaNew Zealand · Tab 10 mgSame brand

🇷🇸Arava®Serbia · 20mg · film tableta · Amicus SRB D.O.O.Same brand

🇸🇦Arava 10MG Film Coated TabletsSaudi Arabia · sanofi-aventisSame brand

🇸🇦Arava 20MG Film Coated TabletsSaudi Arabia · sanofi-aventisSame brand

🇺🇸AravaUnited States · 100MG, 10MG, 20MG · tablet · Sanofi Aventis USSame brand

🇦🇷FludartArgentina · 20 MG · comprimido recubierto · Craveri S.A.I.C.Same form

🇮🇹Leflunomide AurobindoItaly · Compressa rivestita con film · Aurobindo Pharma (Italia) S.R.L.Same form

🇮🇹Leflunomide MedacItaly · Compressa rivestita con film · Medac Gesellschaft Fur Klinische Spezialpraparate MBHSame form

🇸🇦Rheufact 10MG Film Coated TabletsSaudi Arabia · Jazeera Pharmaceutical Industries (JPI)Same form

🇸🇬Bageda Film-Coated Tablet 20MGSingapore · 20.000mg · tablet, film coated · Goldplus Universal Pte LTDSame form

🇸🇬Leflunomide Mevon Film-Coated Tablets 20 MGSingapore · 20.00 MG · tablet, film coated · Novem Pharma Private LimitedSame form

🇺🇸LeflunomideUnited States · 10MG, 20MG · tablet · HeritageSame form

🇧🇷LeflunBrazil · Cristália Produtos Químicos Farmacêuticos Ltda.Same substance

🇪🇺Leflunomide medacEuropean Union · medac Gesellschaft für klinische Spezialpräparate mbHSame substance

🇪🇺Leflunomide ratiopharmEuropean Union · Ratiopharm GmbHSame substance

🇭🇷Leflunomid medacCroatiaSame substance

🇭🇷Leflunomid ratiopharmCroatiaSame substance

🇷🇴LEFLON 20 mgRomania · 20mg · compr. film. · Neola Pharma S.R.L.Same substance

🇷🇴LEFLUNOMIDA SANDOZ 20 mgRomania · 20 mg · compr. film. · Sandoz S.R.L.Same substance

🇷🇴LEFLUNOMIDE ARENA 10 mgRomania · 10mg · compr. film. · Arena Group S.A.Same substance

🇹🇼Arheuma Tablets 10mg "LOTUS"Taiwan · 錠劑 · 美時化學製藥股份有限公司Same substance

🇹🇼Arheuma Tablets 20MG "Lotus"Taiwan · 錠劑 · 美時化學製藥股份有限公司Same substance

Packs

Pack	Code	Status
ARAVA 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA, 3 comprimidos	848176

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Leflunomide
Strength: 100 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 9 Feb 2000
Registration: 99118009
Marketing authorisation holder: Sanofi-Aventis Deutschland Gmbh
Procedure: EU centralised
Supply: Diagnóstico Hospitalario

🇪🇸Spain

AEMPSARAVA 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULALeflunomide · 20 mg · comprimido recubierto con película🇪🇸Spain

AEMPSARAVA 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULALeflunomide · 20 mg · comprimido recubierto con película🇪🇸Spain

AEMPSArava 20 MG Comprimidos Recubiertos con PeliculaLeflunomide · 20 mg · comprimido recubierto con película🇪🇸Spain

AEMPSArava 20 MG Comprimidos Recubiertos con PeliculaLeflunomide · 20 mg · comprimido recubierto con película🇪🇸Spain

AEMPSARAVA 20 mg comprimidos recubiertos con peliculaLeflunomide · 20 mg · comprimido recubierto con película🇪🇸Spain

AEMPSArava 20 MG Comprimidos Recubiertos con PeliculaLeflunomide · 20 mg · comprimido recubierto con película🇪🇸Spain

AEMPSARAVA 20mg comprimidos recubiertos con peliculaLeflunomide · 20 mg · comprimido recubierto con película🇪🇸Spain

AEMPSLEFLUARTIL 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGLeflunomide · 10 mg · comprimido recubierto con película🇪🇸Spain

AEMPSLEFLUARTIL 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGLeflunomide · 20 mg · comprimido recubierto con película🇪🇸Spain

AEMPSLeflunomida Aurovitas 10 MG Comprimidos Recubiertos con Pelicula EfgLeflunomide · 10 mg · comprimido recubierto con película🇪🇸Spain