Bondronat (ibandronic acid)
- Region
- 🇪🇺 EU
- Active substance
- ibandronic acid
- Company
- Atnahs Pharma Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Hypercalcemia; Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone
- CHMP opinion
- Wed 14 Feb 1996
- EU approval
- Tue 25 Jun 1996
- Application
- EMEA/H/C/000101
- ATC
- M05BA06
- Official record
- www.ema.europa.eu
Indication
Bondronat 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.
- 🇪🇺 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- 🇪🇺 Bondenza (previously Ibandronic Acid Roche) Withdrawn · Roche Registration Ltd.
- 🇪🇺 Ibandronic Acid Hexal Application withdrawn · Hexal AG
- 🇪🇺 Destara Withdrawn · Roche Registration Ltd.
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