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ACTIVE SUBSTANCE / INN

BINIMETINIB

Brand name(s): BINIMETINIB, MEKTOVI, Balimek, Mektovi
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
AUTHORISED
Melanoma
ANDA217678
ACTIVE SUBSTANCE
Binimetinib
REGULATORS
FDA · EMA
SPONSORS / MAH
Pierre Fabre Medicament, ALEMBIC PHARMS LTD, Pierre Fabre Médicament
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BINIMETINIBANDA217678ALEMBIC PHARMS LTDNone (Tentative Approval)
MEKTOVINDA210498ARRAY BIOPHARMA INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
MektoviPierre Fabre MedicamentAuthorised20/09/2018Melanoma
BalimekPierre Fabre MédicamentApplication withdrawnMelanoma

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