TECFIDERA

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

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 more about Dimethyl fumarate

Medication package inserts

Below package inserts are available for further reading:

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