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ACTIVE SUBSTANCE / INN

AMIFAMPRIDINE

Brand name(s): Firdapse (previously Zenas), Amifampridine SERB, RUZURGI
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
Lambert-Eaton Myasthenic Syndrome;Paraneoplastic Syndromes, …
NDA209321
ACTIVE SUBSTANCE
Amifampridine
REGULATORS
FDA · EMA
SPONSORS / MAH
SERB SA, JACOBUS PHARM CO INC
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RUZURGINDA209321JACOBUS PHARM CO INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Firdapse (previously Zenas)SERB SAAuthorised23/12/2009Lambert-Eaton Myasthenic Syndrome
Amifampridine SERBSERB SAAuthorised19/05/2022Lambert-Eaton Myasthenic Syndrome;Paraneoplastic Syndromes, Nervous System;Nervo…

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