Ibandronic Acid Hexal (ibandronic acid)
Generic
- Region
- 🇪🇺 EU
- Active substance
- ibandronic acid
- Company
- Hexal AG
- Status
- Application withdrawn
- Therapeutic area
- Hypercalcemia; Breast Neoplasms; Osteoporosis; Neoplasm Metastasis
- Designations
- Generic
- Application
- EMEA/H/C/002366
- ATC
- M05BA06
- Official record
- www.ema.europa.eu
Indication
Ibandronic Acid Hexal is indicated 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.
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.
- 🇪🇺 Ibandronic Acid Teva Authorised · Teva Pharma B.V.
- 🇪🇺 Bondenza (previously Ibandronic Acid Roche) Withdrawn · Roche Registration Ltd.
- 🇪🇺 Destara Withdrawn · Roche Registration Ltd.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.