Basic Information
Ibandronic acid Accord
Regulatory Information
EMEA/H/C/002638
November 18, 2012
15
March 4, 2025
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Ibandronic acid Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ibandronic acid Accord. For practical information about using Ibandronic acid Accord, patients should read the package leaflet or contact their doctor or pharmacist.