🇪🇺 Boniva in European Union

EMA authorised Boniva on 25 June 1996

Marketing authorisations

Application: EMEA/H/C/000103
Marketing authorisation holder: Roche Registration Ltd.
Local brand name: Destara
Indication: Treatment of tumour-induced hypercalcaemia with or without metastases.
Status: withdrawn

Application: EMEA/H/C/000502
Marketing authorisation holder: Roche Registration Ltd.
Local brand name: Bondenza (previously Ibandronic Acid Roche)
Indication: Treatment of osteoporosis in post-menopausal 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.
Status: withdrawn

Application: EMEA/H/C/001195
Marketing authorisation holder: Teva Pharma B.V.
Local brand name: Ibandronic Acid Teva
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.
Status: approved

Application: EMEA/H/C/002025
Marketing authorisation holder: Pharmathen S.A.
Local brand name: Iasibon
Indication: Concentrate for solution for infusion 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. Film-coated Tablets Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Status: approved

Application: EMEA/H/C/002366
Marketing authorisation holder: Hexal AG
Local brand name: Ibandronic Acid Hexal
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.
Status: withdrawn

Application: EMEA/H/C/002367
Marketing authorisation holder: Sandoz GmbH
Local brand name: Ibandronic Acid Sandoz
Indication: Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Status: withdrawn

Application: EMEA/H/C/002638
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Ibandronic acid Accord
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.
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Boniva approved in European Union?

Yes. EMA authorised it on 25 June 1996; EMA authorised it on 25 June 1996; EMA authorised it on 23 February 2004.

Who is the marketing authorisation holder for Boniva in European Union?

Atnahs Pharma Netherlands B.V. holds the EU marketing authorisation.