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.
Bondronat : EPAR - Summary for the public (PDF/82.89 KB)
First published: 09/06/2008
Last updated: 13/05/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Atnahs Pharma Netherlands B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
20/05/2019 Bondronat - EMEA/H/C/000101 - T/0082
- 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.
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Drugs for treatment of bone diseases
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.