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ACTIVE SUBSTANCE / INN

RIBOCICLIB

Brand name(s): RIBOCICLIB, Kisqali
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
Breast Neoplasms
ANDA215677
ACTIVE SUBSTANCE
Ribociclib
REGULATORS
FDA · EMA
SPONSORS / MAH
ALEMBIC PHARMS LTD, Novartis Europharm Limited
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RIBOCICLIBANDA215677ALEMBIC PHARMS LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
KisqaliNovartis Europharm LimitedAuthorised22/08/2017Breast Neoplasms

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