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ACTIVE SUBSTANCE / INN

NILOTINIB

Brand name(s): NILOTINIB, Nilotinib Accord, Tasigna
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA218532
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
ACTIVE SUBSTANCE
Nilotinib
REGULATORS
FDA · EMA
SPONSORS / MAH
TORRENT, Accord Healthcare S.L.U., Novartis Europharm Limited
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NILOTINIBANDA218532TORRENTNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
TasignaNovartis Europharm LimitedAuthorised19/11/2007Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Nilotinib AccordAccord Healthcare S.L.U.Authorised22/08/2024Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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