Cuprior

trientine

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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.

What is Cuprior and what is it used for?

Cuprior is a medicine used to treat patients aged 5 years and older with Wilson’s disease, a genetic condition in which copper absorbed from food builds up in the body, particularly in the liver and the brain, causing damage. Cuprior is used in patients who cannot take D-penicillamine, another medicine for this condition.

Cuprior contains the active substance trientine. It is a hybrid medicine. This means that it is similar to a ‘reference medicine’ (in this case Trientine Dihydrochloride 300 mg capsules) also containing trientine. The difference between Cuprior and the reference medicine is that Cuprior contains another form of trientine (trientine tetrahydrochloride) and does not need to be stored in a refrigerator.

How is Cuprior used?

Cuprior can only be obtained with a prescription and treatment should be started by a specialist with experience in the management of Wilson’s disease.

Cuprior is available as 150 mg tablets. In adults, the total recommended daily dose is from 3 to 6.5 tablets, and in children from 1.5 to 4 tablets. The tablets are taken in 2 to 4 divided doses. Doses are adjusted according to patient response and levels of copper in the body. Cuprior should be taken on an empty stomach, at least one hour before or two hours after meals.

For further information, see the package leaflet.

How does Cuprior work?

The active substance in Cuprior, trientine, is a chelating agent. It works by attaching to copper in the body and forming a complex that is then eliminated in the urine.

How has Cuprior been studied?

The company provided data from the published literature, which show that trientine significantly increases copper elimination in the urine.

The company also carried out a study to compare the levels of trientine in the blood after having taken Cuprior with those for the reference medicine. Results showed that Cuprior produces higher levels of the active substance in the blood than the reference medicine. To take account of this difference, Cuprior is used at lower doses.

What are the benefits and risks of Cuprior?

Since Cuprior is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Cuprior approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Cuprior’s benefits are greater than its risks and recommended that it be approved for use in the EU.

The CHMP noted that trientine has been used for over 30 years to treat patients with Wilson’s disease. Although Cuprior releases more trientine in the body than the reference medicine, this difference can be addressed by lowering the dose, which is in any case adjusted according to patient response and levels of copper in the body.

What measures are being taken to ensure the safe and effective use of Cuprior?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cuprior have been included in the summary of product characteristics and the package leaflet.

Other information about Cuprior

The European Commission granted a marketing authorisation valid throughout the European Union for Cuprior on 5 September 2017.

For more information about treatment with Cuprior, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Cuprior : EPAR - Summary for the public BG = bălgarski 2017-10-03  
Cuprior : EPAR - Summary for the public ES = español 2017-10-03  
Cuprior : EPAR - Summary for the public CS = čeština 2017-10-03  
Cuprior : EPAR - Summary for the public DA = dansk 2017-10-03  
Cuprior : EPAR - Summary for the public DE = Deutsch 2017-10-03  
Cuprior : EPAR - Summary for the public ET = eesti keel 2017-10-03  
Cuprior : EPAR - Summary for the public EL = elliniká 2017-10-03  
Cuprior : EPAR - Summary for the public EN = English 2017-10-03  
Cuprior : EPAR - Summary for the public FR = français 2017-10-03  
Cuprior : EPAR - Summary for the public IT = italiano 2017-10-03  
Cuprior : EPAR - Summary for the public LV = latviešu valoda 2017-10-03  
Cuprior : EPAR - Summary for the public LT = lietuvių kalba 2017-10-03  
Cuprior : EPAR - Summary for the public HU = magyar 2017-10-03  
Cuprior : EPAR - Summary for the public MT = Malti 2017-10-03  
Cuprior : EPAR - Summary for the public NL = Nederlands 2017-10-03  
Cuprior : EPAR - Summary for the public PL = polski 2017-10-03  
Cuprior : EPAR - Summary for the public PT = português 2017-10-03  
Cuprior : EPAR - Summary for the public RO = română 2017-10-03  
Cuprior : EPAR - Summary for the public SK = slovenčina 2017-10-03  
Cuprior : EPAR - Summary for the public SL = slovenščina 2017-10-03  
Cuprior : EPAR - Summary for the public FI = suomi 2017-10-03  
Cuprior : EPAR - Summary for the public SV = svenska 2017-10-03  
Cuprior : EPAR - Summary for the public HR = Hrvatski 2017-10-03  

This EPAR was last updated on 03/10/2017 .

Authorisation details

Product details

Product details for Cuprior
NameCuprior
Agency product numberEMEA/H/C/004005
Active substance

trientine tetrahydrochloride

International non-proprietary name (INN) or common name

trientine

Therapeutic area Hepatolenticular Degeneration
Anatomical therapeutic chemical (ATC) code A16AX

Publication details

Publication details for Cuprior
Marketing-authorisation holder

GMP-Orphan SA

Revision0
Date of issue of marketing authorisation valid throughout the European Union05/09/2017

Contact address:

GMP-Orphan SA
Pepiniere Paris Sante Cochin
27-29 rue du Faubourg Saint-Jacques
75014 Paris
France

Product information

Product information

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

Name Language First published Last updated
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  
Cuprior : EPAR - Product Information HR = Hrvatski 2017-10-03  

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.


Name Language First published Last updated
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  
Cuprior : EPAR - All Authorised presentations HR = Hrvatski 2017-10-03  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Cuprior : EPAR - Public assessment report HR = Hrvatski 2017-10-03  
CHMP summary of positive opinion for Cuprior HR = Hrvatski 2017-04-21  

Authorised

This medicine is approved for use in the European Union

More information on Cuprior

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 19 March 2015. Cuprior was withdrawn from the Community register of orphan medicinal products by the European Commission in July 2017, at the time of the granting of a marketing authorisation.