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/126.29 KB)
First published: 19/07/2019
Last updated: 06/10/2022
|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||
05/05/2022 Prolia - EMEA/H/C/001120 - II/0093
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Drugs for treatment of bone diseases
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.