ARAVA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug ARAVA contains one active pharmaceutical ingredient (API):

1 Leflunomide UNII G162GK9U4W - LEFLUNOMIDE

Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties. A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity. Read about Leflunomide

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ARAVA Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L04AK01	Leflunomide	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AK
Discover more medicines within L04AK01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 5449T, 5450W, 8374R, 8375T
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 502801101113216, 502801102111217, 576720080084617, 576720080084717
Country: CA	Health Products and Food Branch	Identifier(s): 02241888, 02241889, 02241890
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 00242594, 00242602, 00242625, 00291641, 00575551, 00628477, 00790930, 01447683, 01593249, 02654763, 03530253, 04001054, 05126349, 06115342, 06773602, 06907770, 07714949, 09372766, 09605176, 09640706, 10525962, 11524309, 14210008, 14357295
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 29020-09-09, 29111-11-09
Country: EE	Ravimiamet	Identifier(s): 1009921, 1009932, 1009943, 1071818, 1071830, 1212781
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 99118003, 99118007, 99118007IP, 99118007IP1, 99118007IP2, 99118007IP3, 99118007IP4
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 053397, 053413
Country: FR	Base de données publique des médicaments	Identifier(s): 62780055, 65739590, 66218213
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 138292, 138294, 141942, 141952, 21851, 21868, 299609, 299611, 374297, 374299
Country: HK	Department of Health Drug Office	Identifier(s): 46486, 46487, 46488
Country: IE	Health Products Regulatory Authority	Identifier(s): 12311, 12352, 12810, 12837, 12840, 12871, 12880, 30002
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4008, 4010
Country: IT	Agenzia del Farmaco	Identifier(s): 034702074
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999020F1029, 3999020F2025, 3999020F3021
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1004283, 1004284, 1007030, 1010348, 1011948, 1011949, 1027535, 1027536, 1027537, 1075125
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 170M99
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 53600, 53619, 53627
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 8384, 8385
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100111950, 100111966, 100111972
Country: SG	Health Sciences Authority	Identifier(s): 11400P, 11401P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 3463011, 3463012, 3463013
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699809090460, 8699809090477, 8699809090484
Country: US	FDA, National Drug Code	Identifier(s): 0088-2160, 0088-2161, 0088-2162
Country: ZA	Health Products Regulatory Authority	Identifier(s): 33/3.1/0290, 33/3.1/0291