Ibandronic acid Accord (ibandronic acid)
- Region
- 🇪🇺 EU
- Active substance
- ibandronic acid
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Wounds and Injuries; Breast Diseases; Neoplastic Processes; Calcium Metabolism Disorders; Water-Electrolyte Imbalance
- EU approval
- Sun 18 Nov 2012
- Designations
- Generic
- Application
- EMEA/H/C/002638
- ATC
- M05BA06
- Official record
- www.ema.europa.eu
Indication
Ibandronic acid is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour induced hypercalcaemia with or without metastases. 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
- 🇪🇺 Bonviva Authorised · Atnahs Pharma Netherlands B.V.
- 🇪🇺 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- 🇪🇺 Bondenza (previously Ibandronic Acid Roche) Withdrawn · Roche Registration Ltd.
- 🇪🇺 Ibandronic Acid Hexal Application withdrawn · Hexal AG
- 🇪🇺 Destara Withdrawn · Roche Registration Ltd.
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