AUBAGIO

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

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 about Teriflunomide

Medication package inserts

Below package inserts are available for further reading:

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