Ibandronic acid Accord
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.
Ibandronic acid Accord : EPAR - Summary for the public (PDF/83.66 KB)
First published: 06/12/2012
Last updated: 30/10/2017
Ibandronic acid Accord
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Accord Healthcare S.L.U.
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World Trade Center
12/04/2022 Ibandronic acid Accord - EMEA/H/C/002638 - IB/0025
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Drugs for treatment of bone diseases
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.