Ibandronic acid Accord

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ibandronic acid

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 09/04/2019

Authorisation details

Product details
Name
Ibandronic acid Accord
Agency product number
EMEA/H/C/002638
Active substance
ibandronic acid
International non-proprietary name (INN) or common name
ibandronic acid
Therapeutic area (MeSH)
  • Wounds and Injuries
  • Breast Diseases
  • Neoplastic Processes
  • Calcium Metabolism Disorders
  • Neoplasms by Site
  • Water-Electrolyte Imbalance
Anatomical therapeutic chemical (ATC) code
M05BA06
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
18/11/2012
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

20/02/2019 Ibandronic acid Accord - EMEA/H/C/002638 - T/0016

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs for treatment of bone disease

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.

Assessment history

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