Procysbi

RSS

mercaptamine

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

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.

This EPAR was last updated on 08/09/2022

Authorisation details

Product details
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
OrphanOrphan

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
Marketing-authorisation holder
Chiesi Farmaceutici S.p.A
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
05/09/2013
Contact address

Via Palermo 26/A
43122 Parma
Italy

Product information

17/08/2022 Procysbi - EMEA/H/C/002465 - X/0035

Other EU languages available icon 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:

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.

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.

Assessment history

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