This is a summary of the European public assessment report (EPAR) for Bonviva. 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 Bonviva.
Bonviva : EPAR - Summary for the public (PDF/76.85 KB)
First published: 20/03/2009
Last updated: 18/05/2016
|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||
22/05/2019 Bonviva - EMEA/H/C/000501 - T/0067
- 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
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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.