AUBAGIO

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

Active ingredients

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

1	Teriflunomide UNII 1C058IKG3B - TERIFLUNOMIDE
	Teriflunomide is an immunomodulatory agent with anti-inflammatory properties that selectively and reversibly inhibits the mitochondrial enzyme dihydroorotate dehydrogenase (DHO-DH), which functionally connects with the respiratory chain. As a consequence of the inhibition, teriflunomide generally reduces the proliferation of rapidly dividing cells that depend on de novo synthesis of pyrimidine to expand. The exact mechanism by which teriflunomide exerts its therapeutic effect in MS is not fully understood, but this is mediated by a reduced number of lymphocytes.
	Read more about Teriflunomide

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
AUBAGIO 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
L04AK02		L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AK
Discover more medicines within L04AK02

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	2898M
BR	Câmara de Regulação do Mercado de Medicamentos	502818120078517, 576720020052817
CA	Health Products and Food Branch	02416328
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	470-MEE-1014
EE	Ravimiamet	1619579, 1624081, 1624092, 1624104, 1624115, 1670813, 1851511
ES	Centro de información online de medicamentos de la AEMPS	113838002, 113838002IP
FI	Lääkealan turvallisuus- ja kehittämiskeskus	061112, 108819
FR	Base de données publique des médicaments	62160702
GB	Medicines & Healthcare Products Regulatory Agency	245047
HK	Department of Health Drug Office	63504
IE	Health Products Regulatory Authority	88698
IL	מִשְׂרַד הַבְּרִיאוּת	7381
LT	Valstybinė vaistų kontrolės tarnyba	1071145, 1071146, 1071147, 1071148, 1071149, 1092835
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	148M2013
NL	Z-Index G-Standaard, PRK	117838
NZ	Medicines and Medical Devices Safety Authority	15732
PL	Rejestru Produktów Leczniczych	100304493, 100451802
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W69302001, W69302002, W69302003, W69302004, W69302005, W69303001
SG	Health Sciences Authority	14841P
TN	Direction de la Pharmacie et du Médicament	16283011H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699809098541
US	FDA, National Drug Code	58468-0210, 58468-0211
ZA	Health Products Regulatory Authority	47/32.16/0859