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ACTIVE SUBSTANCE / INN

VAMOROLONE

Brand name(s): Agamree, AGAMREE
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Muscular Dystrophy, Duchenne
NDA215239
ACTIVE SUBSTANCE
Vamorolone
REGULATORS
FDA · EMA
SPONSORS / MAH
CATALYST PHARMS, Santhera Pharmaceuticals (Deutschland) GmbH
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
AGAMREENDA215239CATALYST PHARMSPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
AgamreeSanthera Pharmaceuticals (Deutschland) GmbHAuthorised14/12/2023Muscular Dystrophy, Duchenne

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