This is a summary of the European public assessment report (EPAR) for Ferriprox. 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 Ferriprox.
Ferriprox : EPAR - Summary for the public (PDF/57.43 KB)
First published: 28/10/2009
Last updated: 15/07/2016
Ferriprox : EPAR - Risk-management-plan summary (PDF/112.07 KB)
First published: 26/03/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Apotex Europe BV
|Date of issue of marketing authorisation valid throughout the European Union||
11/03/2019 Ferriprox - EMEA/H/C/000236 - IB/0126/G
- 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.
Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Ferriprox in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction.