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ACTIVE SUBSTANCE / INN

PALIPERIDONE

Brand name(s): Byannli (previously Paliperidone Janssen-Cilag International), Niapelf, Invega, Trevicta (previously Paliperidone Janssen), Xeplion, INVEGA, PALIPERIDONE
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA203802
Schizophrenia;Psychotic Disorders
ACTIVE SUBSTANCE
Paliperidone
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen-Cilag International N.V., Janssen-Cilag International NV, Neuraxpharm Pharmaceuticals S.L.
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PALIPERIDONEANDA203279APOTEXPrescription
PALIPERIDONEANDA203802RK PHARMADiscontinued
INVEGANDA021999JANSSEN PHARMSDiscontinued
INVEGANDA021999JANSSEN PHARMSPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Byannli (previously Paliperidone Janssen-Cilag International)Janssen-Cilag International N.V.  Authorised18/06/2020Schizophrenia
Trevicta (previously Paliperidone Janssen)Janssen-Cilag International NVAuthorised05/12/2014Schizophrenia
XeplionJanssen-Cilag International N.V.Authorised04/03/2011Schizophrenia
InvegaJanssen-Cilag International NVAuthorised24/06/2007Schizophrenia;Psychotic Disorders
NiapelfNeuraxpharm Pharmaceuticals S.L.Authorised31/03/2024Schizophrenia

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