ACTIVE SUBSTANCE / INN

IMATINIB

Brand name(s): Imatinib Teva, Imatinib Accord, Imatinib Actavis, Imatinib medac, Glivec, Imatinib Koanaa, Imatinib Teva B.V., Ruvise
EMA LISTED
APPLICATION WITHDRAWN
WITHDRAWN
AUTHORISED
Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Precursor C…
Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Precursor C…
ACTIVE SUBSTANCE
Imatinib
REGULATORS
EMA
SPONSORS / MAH
Medac, Novartis Europharm Ltd, Accord Healthcare S.L.U.
TOTAL APPLICATIONS
8
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Imatinib TevaTeva B.V.Authorised07/01/2013Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Precursor Cell Lymphoblastic Le…
GlivecNovartis Europharm LimitedAuthorised07/11/2001Precursor Cell Lymphoblastic Leukemia-Lymphoma;Gastrointestinal Stromal Tumors;D…
Imatinib AccordAccord Healthcare S.L.U.Authorised30/06/2013Precursor Cell Lymphoblastic Leukemia-Lymphoma;Dermatofibrosarcoma;Myelodysplast…
Imatinib KoanaaKoanaa Healthcare GmbHWithdrawn22/09/2021Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Precursor Cell Lymphoblastic Le…
Imatinib ActavisActavis Group PTC ehfWithdrawn17/04/2013Leukemia, Myelogenous, Chronic, BCR-ABL Positive;Precursor Cell Lymphoblastic Le…
Imatinib medacMedacWithdrawn25/09/2013Precursor Cell Lymphoblastic Leukemia-Lymphoma;Dermatofibrosarcoma;Leukemia, Mye…
Imatinib Teva B.V.Teva B.V.Withdrawn15/11/2017Dermatofibrosarcoma;Gastrointestinal Stromal Tumors;Leukemia, Myelogenous, Chron…
RuviseNovartis Europharm LtdApplication withdrawn

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