Bondronat

RSS

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 Bondronat. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bondronat.

This EPAR was last updated on 04/09/2018

Authorisation details

Product details
Name
Bondronat
Agency product number
EMEA/H/C/000101
Active substance
ibandronic acid
International non-proprietary name (INN) or common name
ibandronic acid
Therapeutic area (MeSH)
  • Hypercalcemia
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Fractures, Bone
Anatomical therapeutic chemical (ATC) code
M05BA06
Publication details
Marketing-authorisation holder
Atnahs Pharma UK Limited
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
24/06/1996
Contact address
Sovereign House
Miles Gray Road
Basildon
SS14 3FR
United Kingdom

Product information

10/07/2018 Bondronat - EMEA/H/C/000101 - IAIN/0080/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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 DISEASES

Therapeutic 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.

Assessment history

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