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ACTIVE SUBSTANCE / INN

MITOTANE

Brand name(s): Lysodren, LYSODREN
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Adrenal Cortex Neoplasms
NDA016885
ACTIVE SUBSTANCE
Mitotane
REGULATORS
FDA · EMA
SPONSORS / MAH
ESTEVE, Esteve Pharmaceuticals, S.A.
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LYSODRENNDA016885ESTEVEPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
LysodrenEsteve Pharmaceuticals, S.A.Authorised28/04/2004Adrenal Cortex Neoplasms

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