Ibandronic Acid Teva (ibandronic acid)
- Region
- 🇪🇺 EU
- Active substance
- ibandronic acid
- Company
- Teva Pharma B.V.
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone; Osteoporosis, Postmenopausal
- CHMP opinion
- Thu 24 Jun 2010
- EU approval
- Fri 17 Sep 2010
- Designations
- Generic
- Application
- EMEA/H/C/001195
- ATC
- M05BA06
- Official record
- www.ema.europa.eu
Indication
Ibandronic acid 50mg Ibandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Ibandronic acid 150mg Treatment of osteoporosis in postmenopausal 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
- 🇪🇺 Iasibon Authorised · Pharmathen S.A.
- 🇪🇺 Ibandronic Acid Sandoz Lapsed · Sandoz GmbH
- 🇪🇺 Ibandronic acid Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Bonviva Authorised · Atnahs Pharma Netherlands B.V.
- 🇪🇺 Bondronat Authorised · Atnahs Pharma Netherlands 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- 🇪🇺 Bondenza (previously Ibandronic Acid Roche) Withdrawn · Roche Registration Ltd.
- 🇪🇺 Ibandronic Acid Hexal Application withdrawn · Hexal AG
- 🇪🇺 Destara Withdrawn · Roche Registration Ltd.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.