Procysbi
mercaptamine
Table of contents
Overview
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.
Authorisation details
Product details | |
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Name |
Procysbi
|
Agency product number |
EMEA/H/C/002465
|
Active substance |
mercaptamine bitartrate
|
International non-proprietary name (INN) or common name |
mercaptamine
|
Therapeutic area (MeSH) |
Cystinosis
|
Anatomical therapeutic chemical (ATC) code |
A16AA04
|
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Chiesi Farmaceutici S.p.A
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
05/09/2013
|
Contact address |
Product information
27/10/2020 Procysbi - EMEA/H/C/002465 - N/0031
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
Other alimentary tract and metabolism products
Therapeutic indication
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.