This is a summary of the European public assessment report (EPAR) for Procysbi. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Procysbi.
For practical information about using Procysbi, patients should read the package leaflet or contact their doctor or pharmacist.
Procysbi : EPAR - Summary for the public (PDF/69.59 KB)
First published: 03/10/2013
Last updated: 03/10/2013
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Chiesi Farmaceutici S.p.A
|Date of issue of marketing authorisation valid throughout the European Union||
11/09/2016 Procysbi - EMEA/H/C/002465 - IB/0026
- 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.
Other alimentary tract and metabolism products
Procysbi is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.