Cuprior

RSS

trientine

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

Overview

This is a summary of the European public assessment report (EPAR) for Cuprior. It explains how the 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 Cuprior.

For practical information about using Cuprior, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 03/10/2017

Authorisation details

Product details
Name
Cuprior
Agency product number
EMEA/H/C/004005
Active substance
Trientine tetrahydrochloride
International non-proprietary name (INN) or common name
trientine
Therapeutic area (MeSH)
Hepatolenticular Degeneration
Anatomical therapeutic chemical (ATC) code
A16AX
Publication details
Marketing-authorisation holder
GMP-Orphan SA
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
05/09/2017
Contact address
Pepiniere Paris Sante Cochin
27-29 rue du Faubourg Saint-Jacques
75014 Paris
France

Product information

05/09/2017 Cuprior - EMEA/H/C/004005 - -

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

Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.

Assessment history

How useful was this page?

Add your rating