This is a summary of the European Public Assessment Report (EPAR) for Prolia. 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 Prolia.
Prolia : EPAR - Summary for the public (PDF/87.73 KB)
First published: 23/06/2010
Last updated: 12/09/2018
Prolia : EPAR - Risk-management-plan summary (PDF/329.13 KB)
First published: 19/07/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Amgen Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
04/07/2019 Prolia - EMEA/H/C/001120 - PSUSA/00000954/201809
- 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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Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures.
Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.