Procysbi

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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 01/08/2018

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
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
Marketing-authorisation holder
Chiesi Farmaceutici S.p.A
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
06/09/2013
Contact address
Via Palermo 26/A
43122 Parma
Italy

Product information

26/07/2018 Procysbi - EMEA/H/C/002465 - R/0019

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.

Assessment history

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