ACTIVE SUBSTANCE / INN

RITUXIMAB

Brand name(s): Ruxience, RITUXAN HYCELA, Ituxredi, Blitzima, Ritemvia, Truxima, Rituzena (previously Tuxella), Rixathon, MabThera, Riximyo, RITUXAN, Rituximab Mabion
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
WITHDRAWN
Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;Microscopic Poly…
Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell…
ACTIVE SUBSTANCE
Rituximab
REGULATORS
FDA · EMA
SPONSORS / MAH
Celltrion Healthcare Hungary Kft., Sandoz GmbH, Reddy Holding GmbH
TOTAL APPLICATIONS
12
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RITUXANBLA103705GENENTECHPrescription
RITUXAN HYCELABLA761064GENENTECH INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RixathonSandoz GmbHAuthorised15/06/2017Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;Leukemia, Lymphocytic, Chronic, B-Ce…
TruximaCelltrion Healthcare Hungary Kft.Authorised17/02/2017Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;Wegener Granulomatosis;Leukemia, Lym…
BlitzimaCelltrion Healthcare Hungary Kft.Authorised13/07/2017Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell
RiximyoSandoz GmbHAuthorised15/06/2017Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;Microscopic Polyangiitis;Wegener Gra…
RuxiencePfizer Europe MA EEIGAuthorised01/04/2020Leukemia, Lymphocytic, Chronic, B-Cell;Arthritis, Rheumatoid;Microscopic Polyang…
ItuxrediReddy Holding GmbHAuthorised19/09/2024Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell;Arthritis, Rheumato…
MabTheraRoche Registration GmbHAuthorised02/06/1998Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;Leukemia, Lymphocytic, Chronic, B-Ce…
RitemviaCelltrion Healthcare Hungary Kft.Withdrawn13/07/2017Lymphoma, Non-Hodgkin;Microscopic Polyangiitis;Wegener Granulomatosis
Rituximab MabionMabion Spolka AkcyjnaApplication withdrawnLymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell;Arthritis, Rheumato…
Rituzena (previously Tuxella)Celltrion Healthcare Hungary Kft.Withdrawn13/07/2017Lymphoma, Non-Hodgkin;Microscopic Polyangiitis;Leukemia, Lymphocytic, Chronic, B…

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