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ACTIVE SUBSTANCE / INN

MIGLUSTAT

Brand name(s): Zavesca, Yargesa, OPFOLDA, MIGLUSTAT, YARGESA, Miglustat Dipharma, Miglustat Gen.Orph, ZAVESCA, Opfolda
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
Gaucher Disease;Niemann-Pick Diseases
Gaucher Disease
ACTIVE SUBSTANCE
Miglustat
REGULATORS
FDA · EMA
SPONSORS / MAH
AMICUS THERAP US, Janssen Cilag International NV, CHARTWELL RX
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
MIGLUSTATANDA209325CHARTWELL RXDiscontinued
YARGESAANDA209821EDENBRIDGE PHARMSPrescription
MIGLUSTATANDA219111NAVINTA LLCPrescription
ZAVESCANDA021348ACTELIONPrescription
OPFOLDANDA215211AMICUS THERAP USPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ZavescaJanssen Cilag International NVAuthorised20/11/2002Gaucher Disease;Niemann-Pick Diseases
YargesaPiramal Critical Care B.V.Authorised22/03/2017Gaucher Disease
Miglustat DipharmaDipharma Arzneimittel GmbHAuthorised18/02/2019Gaucher Disease
Miglustat Gen.OrphGen.OrphAuthorised09/11/2017Gaucher Disease
OpfoldaAmicus Therapeutics Europe LimitedAuthorised26/06/2023Glycogen Storage Disease Type II

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