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ACTIVE SUBSTANCE / INN

OPICAPONE

Brand name(s): ONGENTYS, Ongentys, Ontilyv
FDA LISTED
EMA LISTED
PRESCRIPTION
LAPSED
AUTHORISED
NDA212489
Parkinson Disease
ACTIVE SUBSTANCE
Opicapone
REGULATORS
FDA · EMA
SPONSORS / MAH
Bial Portela & Companhia S.A., Bial - Portela Cª, S.A., AMNEAL
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ONGENTYSNDA212489AMNEALPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OngentysBial - Portela Cª, S.A.Authorised24/06/2016Parkinson Disease
OntilyvBial Portela & Companhia S.A.Lapsed21/02/2022Parkinson Disease

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