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ACTIVE SUBSTANCE / INN

RELUGOLIX

Brand name(s): ORGOVYX, MYFEMBREE, Orgovyx
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NDA214621
NDA214846
ACTIVE SUBSTANCE
Relugolix
REGULATORS
FDA · EMA
SPONSORS / MAH
SUMITOMO PHARMA AM, Accord Healthcare S.L.U.
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
MYFEMBREENDA214846SUMITOMO PHARMA AMPrescription
ORGOVYXNDA214621SUMITOMO PHARMA AMPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OrgovyxAccord Healthcare S.L.U.Authorised29/04/2022Prostatic Neoplasms

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