Cuprymina

copper (64Cu) chloride

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

What is Cuprymina?

Cuprymina is a solution that contains the radioactive substance copper (64Cu) chloride. 64Cu is a radioactive form of copper.

What is Cuprymina used for?

Cuprymina is not used on its own but is used for radiolabelling other medicines. Radiolabelling is a technique where a substance is labelled with a radioactive compound. Once the substance is radiolabelled with Cuprymina, it then carries the radioactivity to where it is needed in the body.

Cuprymina is used to radiolabel medicines that have been specially developed for use with copper (64Cu) chloride.

Medicines to be radiolabelled with Cuprymina can only be obtained with a prescription.

How is Cuprymina used?

Cuprymina is only to be used by specialists who have experience in radiolabelling. Cuprymina is never given directly to the patient. Radiolabelling of a medicine takes place outside the body in a laboratory setting. The radiolabelled medicine is then given to the patient according to the instructions in that medicine’s summary of product characteristics (SmPC).

How does Cuprymina work?

The active substance in Cuprymina, copper (64Cu) chloride, is a radioactive compound that emits a type of radiation known as beta radiation. When a medicine is radiolabelled with Cuprymina, the medicine will carry the radiation to the particular site or type of cell in the body that is targeted by the medicine. The intended effect of the radiation will depend on the nature of the medicine that has been radiolabelled.

How has Cuprymina been studied?

The company presented information from the scientific literature on the potential uses of Cuprymina. Some of the scientific literature presented showed how radiolabelling with radioactive forms of copper, including 64Cu, were used together with imaging techniques to detect the site and spread of tumours and how it could potentially be used to treat various types of cancer.

What benefit has Cuprymina shown during the studies?

The information supplied by the company showed that Cuprymina can be used to radiolabel medicines with 64Cu, with potential utility for detecting of the sites and spread of tumours.

What is the risk associated with Cuprymina?

The side effects with Cuprymina depend largely on the medicine it has been used to radiolabel and will be described in that medicine’s package leaflet. Cuprymina itself is radioactive and so its use in radiolabelling may carry a risk of cancer and hereditary defects. The doctor will ensure that the risks linked to the radioactive exposure are lower than the risks from the disease itself.

Cuprymina must not be given directly to any patient. It must not be used in people who are hypersensitive (allergic) to copper (64Cu) chloride or any of the other ingredients. It must not be used in women who are known to be or may be pregnant. More information on the restrictions on the use of medicines radiolabelled with Cuprymina will be found in their package leaflets.

Why has Cuprymina been approved?

Given the well-known risks of exposure to radiation through radiolabelling, the Committee decided that Cuprymina is only to be used if justified by the likely medical benefit. The CHMP concluded that there are no major safety concerns with regards to potential copper toxicity, since Cuprymina is used at very low doses. Therefore, the CHMP decided that Cuprymina’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Cuprymina

The European Commission granted a marketing authorisation valid throughout the European Union for Cuprymina on 23 August 2012.

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

Name Language First published Last updated
Cuprymina: EPAR - Summary for the public BG = bălgarski 03/09/2012  
Cuprymina: EPAR - Summary for the public ES = español 03/09/2012  
Cuprymina: EPAR - Summary for the public CS = čeština 03/09/2012  
Cuprymina: EPAR - Summary for the public DA = dansk 03/09/2012  
Cuprymina: EPAR - Summary for the public DE = Deutsch 03/09/2012  
Cuprymina: EPAR - Summary for the public ET = eesti keel 03/09/2012  
Cuprymina: EPAR - Summary for the public EL = elliniká 03/09/2012  
Cuprymina: EPAR - Summary for the public EN = English 03/09/2012  
Cuprymina: EPAR - Summary for the public FR = français 03/09/2012  
Cuprymina: EPAR - Summary for the public IT = italiano 03/09/2012  
Cuprymina: EPAR - Summary for the public LV = latviešu valoda 03/09/2012  
Cuprymina: EPAR - Summary for the public LT = lietuvių kalba 03/09/2012  
Cuprymina: EPAR - Summary for the public HU = magyar 03/09/2012  
Cuprymina: EPAR - Summary for the public MT = Malti 03/09/2012  
Cuprymina: EPAR - Summary for the public NL = Nederlands 03/09/2012  
Cuprymina: EPAR - Summary for the public PL = polski 03/09/2012  
Cuprymina: EPAR - Summary for the public PT = português 03/09/2012  
Cuprymina: EPAR - Summary for the public RO = română 03/09/2012  
Cuprymina: EPAR - Summary for the public SK = slovenčina 03/09/2012  
Cuprymina: EPAR - Summary for the public SL = slovenščina 03/09/2012  
Cuprymina: EPAR - Summary for the public FI = suomi 03/09/2012  
Cuprymina: EPAR - Summary for the public SV = svenska 03/09/2012  

This EPAR was last updated on 07/03/2016 .

Authorisation details

Product details

Product details for Cuprymina
NameCuprymina
Agency product numberEMEA/H/C/002136
Active substance

copper (64Cu) chloride

International non-proprietary name (INN) or common name

copper (64Cu) chloride

Therapeutic area Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code V
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Cuprymina
Marketing-authorisation holder

Sparkle S.r.l  

Revision4
Date of issue of marketing authorisation valid throughout the European Union23/08/2012

Contact address:

Sparkle S.r.l
Via Livatino 33
62100 Macerata (MC)
Italy

Product information

Product information

17/02/2016  Cuprymina -EMEA/H/C/002136 -IAIN/0010; IAIN/0011

Name Language First published Last updated
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016
Cuprymina: EPAR - Product Information SV = svenska 03/09/2012 07/03/2016

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
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  
Cuprymina: EPAR - All Authorised presentations SV = svenska 03/09/2012  

Pharmacotherapeutic group

Various

Therapeutic indication

Cuprymina is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Cuprymina : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 28/04/2015 07/03/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Cuprymina: EPAR - Public assessment report SV = svenska 03/09/2012  
CHMP summary of positive opinion for Cuprymina SV = svenska 22/06/2012  

Authorised

This medicine is approved for use in the European Union