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ACTIVE SUBSTANCE / INN

PERAMPANEL

Brand name(s): PERAMPANEL, Fycompa, FYCOMPA
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
Epilepsies, Partial
ANDA209877
ACTIVE SUBSTANCE
Perampanel
REGULATORS
FDA · EMA
SPONSORS / MAH
CATALYST PHARMS, ACCORD HLTHCARE, Eisai GmbH
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PERAMPANELANDA218152MSNPrescription
FYCOMPANDA202834CATALYST PHARMSPrescription
PERAMPANELANDA209877ACCORD HLTHCARENone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
FycompaEisai GmbHAuthorised23/07/2012Epilepsies, Partial

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