Data from EMC - Curated by Toby Galbraith - Last updated 02 May 2017

Licensing authority

EMA (European Medicines Agency)

Indication(s)

Treatment of osteoporosis
- in post-menopausal women
- in adult 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
- in adult men
at increased risk of fracture.

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

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/000595
Orphan designation No
Date First Approved 15-04-2005
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Novartis Europharm Limited
Warnings

European Medicines Agency concludes class review of bisphosphonates and atypical fractures (European Medicines Agency - Press Release 15/04/2011)

Rare atypical fr