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ACTIVE SUBSTANCE / INN

OFATUMUMAB

Brand name(s): KESIMPTA, Kesimpta, Arzerra, ARZERRA
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
AUTHORISED
Leukemia, Lymphocytic, Chronic, B-Cell
BLA125326
ACTIVE SUBSTANCE
Ofatumumab
REGULATORS
FDA · EMA
SPONSORS / MAH
NOVARTIS, Novartis Europharm Ltd, Novartis Europharm Limited
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
KESIMPTABLA125326NOVARTISPrescription
ARZERRABLA125326NOVARTISPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
KesimptaNovartis Europharm LimitedAuthorised26/03/2021Multiple Sclerosis, Relapsing-Remitting
ArzerraNovartis Europharm LtdWithdrawn19/04/2010Leukemia, Lymphocytic, Chronic, B-Cell

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