Cystagon

RSS

mercaptamine bitartrate

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

Overview

This is a summary of the European public assessment report (EPAR) for Cystagon. 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 Cystagon.

This EPAR was last updated on 31/08/2018

Authorisation details

Product details
Name
Cystagon
Agency product number
EMEA/H/C/000125
Active substance
mercaptamine bitartrate
International non-proprietary name (INN) or common name
mercaptamine bitartrate
Therapeutic area (MeSH)
Cystinosis
Anatomical therapeutic chemical (ATC) code
A16AA04
Publication details
Marketing-authorisation holder
Orphan Europe S.A.R.L.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
23/06/1997
Contact address
Immeuble 'Le Wilson'
F-92058 Paris-La-Défense
France

Product information

24/07/2018 Cystagon - EMEA/H/C/000125 - N/0053

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

Cystagon 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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