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ACTIVE SUBSTANCE / INN

RUXOLITINIB

Brand name(s): Opzelura, Ruxolitinib, Jakavi
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
Vitiligo
NDA219660
ACTIVE SUBSTANCE
Ruxolitinib
REGULATORS
FDA · EMA
SPONSORS / MAH
Incyte Biosciences Distribution B.V., APOTEX, Novartis Europharm Limited
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RuxolitinibNDA219660APOTEXNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
JakaviNovartis Europharm LimitedAuthorised23/08/2012Myeloproliferative Disorders;Polycythemia Vera;Graft vs Host Disease
OpzeluraIncyte Biosciences Distribution B.V.Authorised19/04/2023Vitiligo

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