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Bondenza (previously Ibandronic Acid Roche) (ibandronic acid)

Region
🇪🇺 EU
Active substance
ibandronic acid
Company
Roche Registration Ltd.
Status
Withdrawn
Therapeutic area
Osteoporosis, Postmenopausal
EU approval
Mon 23 Feb 2004
Application
EMEA/H/C/000502
ATC
M05BA06
Official record
www.ema.europa.eu

Indication

Treatment of osteoporosis in post-menopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated. Efficacy on femoral-neck fractures has not been established.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.