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ACTIVE SUBSTANCE / INN

NITISINONE

Brand name(s): Nityr, NITISINONE, NITYR, Nitisinone MDK (previously Nitisinone MendeliKABS), HARLIKU, ORFADIN, Orfadin
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
NDA206356
ANDA212390
ACTIVE SUBSTANCE
Nitisinone
REGULATORS
FDA · EMA
SPONSORS / MAH
Cycle Pharmaceuticals (Europe) Ltd, MendeliKABS Europe Ltd, SWEDISH ORPHAN
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NITISINONEANDA215908TORRENTDiscontinued
ORFADINNDA206356SWEDISH ORPHANPrescription
HARLIKUNDA209449CYCLEPrescription
NITYRNDA209449CYCLEPrescription
NITISINONEANDA212390MEDUNIKPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OrfadinSwedish Orphan Biovitrum International ABAuthorised21/02/2005Tyrosinemias
Nitisinone MDK (previously Nitisinone MendeliKABS)MendeliKABS Europe LtdWithdrawn24/08/2017Tyrosinemias
NityrCycle Pharmaceuticals (Europe) LtdAuthorised26/07/2018Tyrosinemias

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