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ACTIVE SUBSTANCE / INN

CHOLIC ACID

Brand name(s): Orphacol, CHOLBAM, Kolbam
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
AUTHORISED
Digestive System Diseases;Metabolism, Inborn Errors
Metabolism, Inborn Errors
ACTIVE SUBSTANCE
Cholic Acid
REGULATORS
FDA · EMA
SPONSORS / MAH
Theravia, MIRUM, Retrophin Europe Ltd
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
CHOLBAMNDA205750MIRUMPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OrphacolTheraviaAuthorised12/09/2013Digestive System Diseases;Metabolism, Inborn Errors
KolbamRetrophin Europe LtdWithdrawn20/11/2015Metabolism, Inborn Errors

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