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Product No EMEA/H/C/000595
Brand Name Aclasta
Nonproprietary Name zoledronic acid
API zoledronic acid
ATC Code M05BA08
Indications Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture. Treatment of Paget's disease of the bone.
Orphan Drug no
Generics no
Marketing Authorization Holder Novartis Europharm Limited
Status Authorised
Authorization Date 2005-04-15
Version 21
Condition Approval no
Exceptions no
Biosimilar no
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