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ACTIVE SUBSTANCE / INN

MIRDAMETINIB

Brand name(s): Ezmekly, GOMEKLI
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Neurofibromatosis 1;Neurofibroma, Plexiform
NDA219379
ACTIVE SUBSTANCE
Mirdametinib
REGULATORS
FDA · EMA
SPONSORS / MAH
SpringWorks Therapeutics Ireland Limited, SPRINGWORKS
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
GOMEKLINDA219379SPRINGWORKSPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
EzmeklySpringWorks Therapeutics Ireland LimitedAuthorised17/07/2025Neurofibromatosis 1;Neurofibroma, Plexiform

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