Cuprior
trientine
Table of contents
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.
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 |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
05/09/2017
|
Contact address |
Product information
05/08/2020 Cuprior - EMEA/H/C/004005 - IAIN/0013/G
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.