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Zoledronic acid Teva Generics

Active Substance: zoledronic acid monohydrate
Common Name: zoledronic acid
ATC Code: M05BA08
Marketing Authorisation Holder: Teva Generics B.V
Active Substance: zoledronic acid monohydrate
Status: Withdrawn
Authorisation Date: 2014-03-27
Therapeutic Area: Osteoporosis Osteitis Deformans
Pharmacotherapeutic Group: bisphosphonates

Therapeutic Indication

Treatment of osteoporosis

  • in post-menopausal women
  • in adult men

at increased risk of fracture, including those with recent low-trauma hip fracture.

Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy

  • in post-menopausal women
  • in adult men

at increased risk of fracture.

Treatment of Paget's disease of the bone in adults.

The marketing authorisation for Zoledronic Acid Teva Generics has been withdrawn at the request of the marketing-authorisation holder.

Source: European Medicines Agency

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