ACTIVE SUBSTANCE / INN

CARGLUMIC ACID

Brand name(s): CARGLUMIC ACID, CARBAGLU, Ucedane, Carbaglu
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NDA022562
Amino Acid Metabolism, Inborn Errors;Propionic Acidemia
ACTIVE SUBSTANCE
Carglumic Acid
REGULATORS
FDA · EMA
SPONSORS / MAH
RECORDATI RARE, NOVITIUM PHARMA, Tour Hekla
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
CARGLUMIC ACIDANDA213729NOVITIUM PHARMAPrescription
CARBAGLUNDA022562RECORDATI RAREPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
CarbagluTour HeklaAuthorised24/01/2003Amino Acid Metabolism, Inborn Errors;Propionic Acidemia
UcedaneEurocept International BVAuthorised23/06/2017Hyperammonemia;Amino Acid Metabolism, Inborn Errors

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