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ACTIVE SUBSTANCE / INN

DENOSUMAB

Brand name(s): Vevzuo, Acvybra, Stoboclo, Xbonzy, Zadenvi, Rolcya, Degevma, Osvyrti, Ponlimsi, Yaxwer, Jubereq, Osqay, Obodence, Xbryk, Izamby, Bomyntra, Bildyos, Wyost, PROLIA, Bilprevda, Denosumab Intas, Zvogra, Denbrayce, Conexxence, Jubbonti, Prolia, Evfraxy, Junod, XGEVA, Enwylma, Kefdensis, Xgeva, Osenvelt
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Osteoporosis;Osteoporosis, Postmenopausal;Bone Resorption
BLA125320
ACTIVE SUBSTANCE
Denosumab
REGULATORS
FDA · EMA
SPONSORS / MAH
AMGEN, Celltrion Healthcare Hungary Kft., Teva GmbH
TOTAL APPLICATIONS
33
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PROLIABLA125320AMGENPrescription
XGEVABLA125320AMGENPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
KefdensisStada Arzneimittel AGAuthorised17/11/2025Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal
XbonzyReddy Holding GmbHAuthorised17/11/2025Giant Cell Tumor of Bone;Neoplasms, Bone Tissue
ConexxenceFresenius Kabi Deutschland GmbHAuthorised18/07/2025Osteoporosis;Osteoporosis, Postmenopausal;Bone Resorption
AcvybraReddy Holding GmbHAuthorised17/11/2025Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal
OsqayTheramex Ireland LimitedAuthorised08/01/2026Bone Resorption
EvfraxyBiosimilar Collaborations Ireland LimitedAuthorised30/06/2025Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal
VevzuoBiosimilar Collaborations Ireland LimitedAuthorised25/06/2025Neoplasms, Bone Tissue;Giant Cell Tumor of Bone
BildyosSciencepharma Sp. z o.oAuthorised17/09/2025Bone Resorption;Osteoporosis, Postmenopausal;Osteoporosis
OsvyrtiAccord Healthcare S.L.U.Authorised26/05/2025Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal
PonlimsiTeva GmbHAuthorised17/11/2025Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal

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