Bonviva (ibandronic acid)
- Region
- 🇪🇺 EU
- Active substance
- ibandronic acid
- Company
- Atnahs Pharma Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Osteoporosis, Postmenopausal
- CHMP opinion
- Thu 23 Oct 2003
- EU approval
- Mon 23 Feb 2004
- Application
- EMEA/H/C/000501
- ATC
- M05BA06
- Official record
- www.ema.europa.eu
Indication
Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). 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
- 🇪🇺 Iasibon Authorised · Pharmathen S.A.
- 🇪🇺 Ibandronic Acid Sandoz Lapsed · Sandoz GmbH
- 🇪🇺 Ibandronic acid Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Bondronat Authorised · Atnahs Pharma Netherlands B.V.
- 🇪🇺 Ibandronic Acid Teva Authorised · Teva Pharma B.V.
- 🇪🇺 Bondenza (previously Ibandronic Acid Roche) Withdrawn · Roche Registration Ltd.
- 🇪🇺 Ibandronic Acid Hexal Application withdrawn · Hexal AG
- 🇪🇺 Destara Withdrawn · Roche Registration Ltd.
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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.