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ACTIVE SUBSTANCE / INN

OMALIZUMAB

Brand name(s): Xolair, Omlyclo, XOLAIR
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Asthma;Urticaria
BLA103976
ACTIVE SUBSTANCE
Omalizumab
REGULATORS
FDA · EMA
SPONSORS / MAH
GENENTECH, Celltrion Healthcare Hungary Kft., Novartis Europharm Limited
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
XOLAIRBLA103976GENENTECHPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OmlycloCelltrion Healthcare Hungary Kft.Authorised16/05/2024Asthma;Urticaria
XolairNovartis Europharm LimitedAuthorised25/10/2005Asthma;Urticaria;Rhinitis

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