Prolia

RSS

denosumab

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 11/07/2018

Authorisation details

Product details
Name
Prolia
Agency product number
EMEA/H/C/001120
Active substance
denosumab
International non-proprietary name (INN) or common name
denosumab
Therapeutic area (MeSH)
  • Bone Resorption
  • Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code
M05BX04
Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
26/05/2010
Contact address
Minervum 7061
NL-4817 ZK Breda
The Netherlands

Product information

04/06/2018 Prolia - EMEA/H/C/001120 - IG/0946

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 the treatment of bone diseases

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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