ARAVA

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

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 more about Leflunomide

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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