ACTIVE SUBSTANCE / INN

IBANDRONIC ACID

Brand name(s): Destara, Ibandronic Acid Teva, Ibandronic Acid Hexal, Ibandronic acid Accord, Bonviva, Ibandronic Acid Sandoz, Bondronat, Bondenza (previously Ibandronic Acid Roche), Iasibon
EMA LISTED
APPLICATION WITHDRAWN
WITHDRAWN
AUTHORISED
Hypercalcemia;Breast Neoplasms;Osteoporosis;Neoplasm Metasta…
Hypercalcemia;Breast Neoplasms;Neoplasm Metastasis;Fractures…
ACTIVE SUBSTANCE
Ibandronic Acid
REGULATORS
EMA
SPONSORS / MAH
Atnahs Pharma Netherlands B.V., Pharmathen S.A., Hexal AG
TOTAL APPLICATIONS
9
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Ibandronic acid AccordAccord Healthcare S.L.U.Authorised18/11/2012Wounds and Injuries;Breast Diseases;Neoplastic Processes;Calcium Metabolism Diso…
BonvivaAtnahs Pharma Netherlands B.V.Authorised23/02/2004Osteoporosis, Postmenopausal
BondronatAtnahs Pharma Netherlands B.V.Authorised25/06/1996Hypercalcemia;Breast Neoplasms;Neoplasm Metastasis;Fractures, Bone
IasibonPharmathen S.A.Authorised21/01/2011Hypercalcemia;Fractures, Bone;Neoplasm Metastasis;Breast Neoplasms
Ibandronic Acid TevaTeva Pharma B.V.Authorised17/09/2010Breast Neoplasms;Neoplasm Metastasis;Fractures, Bone;Osteoporosis, Postmenopausa…
Ibandronic Acid SandozSandoz GmbHAuthorised26/07/2011Breast Neoplasms;Neoplasm Metastasis;Fractures, Bone
Bondenza (previously Ibandronic Acid Roche)Roche Registration Ltd.Withdrawn23/02/2004Osteoporosis, Postmenopausal
Ibandronic Acid HexalHexal AGApplication withdrawnHypercalcemia;Breast Neoplasms;Osteoporosis;Neoplasm Metastasis
DestaraRoche Registration Ltd.Withdrawn25/06/1996Hypercalcemia;Cancer

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