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ACTIVE SUBSTANCE / INN

TOLVAPTAN

Brand name(s): JYNARQUE, Samsca, Jinarc, SAMSCA, Tolvaptan Accord, TOLVAPTAN
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
Inappropriate ADH Syndrome
Polycystic Kidney, Autosomal Dominant
ACTIVE SUBSTANCE
Tolvaptan
REGULATORS
FDA · EMA
SPONSORS / MAH
OTSUKA, APOTEX, Accord Healthcare S.L.U.
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TOLVAPTANANDA207605APOTEXPrescription
JYNARQUENDA204441OTSUKAPrescription
SAMSCANDA022275OTSUKAPrescription
SAMSCANDA022275OTSUKADiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Tolvaptan AccordAccord Healthcare S.L.U.AuthorisedInappropriate ADH Syndrome
JinarcOtsuka Pharmaceutical Netherlands B.V.Authorised27/05/2015Polycystic Kidney, Autosomal Dominant
SamscaOtsuka Pharmaceutical Netherlands B.V.Authorised02/08/2009Inappropriate ADH Syndrome

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