TECFIDERA

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

Active ingredients

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

1 Dimethyl fumarate UNII FO2303MNI2 - DIMETHYL FUMARATE

The anti-inflammatory and immunomodulating effects of dimethyl fumarate and its metabolite monomethyl fumarate are not fully elucidated but are thought to be mainly due to the interaction with the intracellular reduced glutathione of cells directly involved in the pathogenesis of psoriasis. Their main activity is considered to be immunomodulatory, resulting in a shift in T helper cells (Th) from the Th1 and Th17 profile to a Th2 phenotype. Read about Dimethyl fumarate

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
TECFIDERA Gastro-resistant hard capsule	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
L04AX07		L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AX Other immunosuppressants
Discover more medicines within L04AX07

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): 2896K, 2943X, 2966D
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 538315070000502, 538315070001002
Country: CA	Health Products and Food Branch	Identifier(s): 02404508, 02420201
Country: EE	Ravimiamet	Identifier(s): 1638693, 1638705, 1683345
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 113837001, 113837002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 392438, 400574
Country: FR	Base de données publique des médicaments	Identifier(s): 63597651, 67104351
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 240349, 240352, 368987, 368990
Country: HK	Department of Health Drug Office	Identifier(s): 64410, 64411
Country: IE	Health Products Regulatory Authority	Identifier(s): 88464, 88491
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7376
Country: IT	Agenzia del Farmaco	Identifier(s): 043217013, 043217025, 043217037
Country: JP	医薬品医療機器総合機構	Identifier(s): 1190024M1028, 1190024M2024
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1072661, 1072662, 1076191
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 438M
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 117870, 117889
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 16187, 16188
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100323190, 100323208
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W65150001, W65151001
Country: SG	Health Sciences Authority	Identifier(s): 15053P, 15054P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 10913031H, 10913032H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699783160012, 8699783160029, 8699783160036
Country: US	FDA, National Drug Code	Identifier(s): 64406-005, 64406-006