TRUXIMA

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

Active ingredients

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

1
UNII 4F4X42SYQ6 - RITUXIMAB
 

Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes. The antigen is expressed on >95% of all B cell non-Hodgkin’s lymphomas.

 
Read more about Rituximab

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 TRUXIMA Concentrate for solution for infusion 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
L01FA01 Rituximab L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FA CD20 (Clusters of Differentiation 20) inhibitors
Discover more medicines within L01FA01

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 10179R, 10193L, 10576P, 10583B, 10591K, 10593M, 11790M, 11800C, 11804G, 11805H, 11810N, 11813R, 11935E, 11936F, 4613T, 4614W, 4615X, 7257Y, 7258B, 7259C, 9544H, 9611W
BR Câmara de Regulação do Mercado de Medicamentos 545120040000407, 545120040000507
CA Health Products and Food Branch 02478382, 02478390
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 123-MBE-0218
EE Ravimiamet 1739448, 1770993
ES Centro de información online de medicamentos de la AEMPS 1161167001, 1161167002
FI Lääkealan turvallisuus- ja kehittämiskeskus 175351, 418667
FR Base de données publique des médicaments 64102473, 64237955
GB Medicines & Healthcare Products Regulatory Agency 341657, 346138
HK Department of Health Drug Office 66443, 66444
IL מִשְׂרַד הַבְּרִיאוּת 8342, 8343
IT Agenzia del Farmaco 045266018, 045266020
LT Valstybinė vaistų kontrolės tarnyba 1082365, 1085387
NL Z-Index G-Standaard, PRK 51004, 51012
NZ Medicines and Medical Devices Safety Authority 19626, 19647
PL Rejestru Produktów Leczniczych 100387562, 100463050
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W63707001, W63906001
SG Health Sciences Authority 15671P
TR İlaç ve Tıbbi Cihaz Kurumu 8680614140129, 8699862950244
US FDA, National Drug Code 63459-103, 63459-104

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