Wilzin

zinc

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Wilzin?

Wilzin is a medicine that contains the active substance zinc. It is available as capsules (blue: 25 mg; orange: 50 mg).

What is Wilzin used for?

Wilzin is used to treat Wilson’s disease. Wilson’s disease is a rare inherited disorder where patients lack an enzyme that is needed to eliminate the copper contained in food from the body. This results in copper building up in the body, first in the liver, then in other organs such as the eye and the brain. This causes a variety of effects, including liver disease and damage to the nervous system.

Because the number of patients with Wilson’s disease is low, the disease is considered ‘rare’, and Wilzin was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 31 July 2001.

The medicine can only be obtained with a prescription.

How is Wilzin used?

Wilzin treatment should be started by a doctor who has experience in the treatment of Wilson’s disease.

The usual dose for adults is 50 mg three times a day. A reduced dose is used in children. Wilzin should be taken on an empty stomach, at least one hour before or two to three hours after meals. Wilzin is a long-term treatment. Patients who are switching from a ‘chelating agent’ (another type of medicine for Wilson’s disease) to Wilzin should continue to take the chelating agent for two to three weeks after starting Wilzin, because Wilzin takes some time to start working fully. The maximum dose of Wilzin is 50 mg five times a day. For more information, see the package leaflet.

How does Wilzin work?

The active substance in Wilzin is the zinc cation (positively charged zinc), which blocks the absorption of copper from the diet. It works by stimulating the body to produce a protein called metallothionein in the cells lining the gut. This protein attaches to copper and prevents it being transferred into the blood. The copper is then passed out of the body in the stools. Over time, the amount of copper in the body falls, improving the symptoms of the disease. Zinc has been used to treat Wilson’s disease since 1958.

How has Wilzin been studied?

Because zinc has been used to treat Wilson’s disease for many years, the company presented the results of studies from the published literature. In total, data to support the use of Wilzin came from 255 patients with Wilson’s disease. The main study involved 148 patients who were treated with Wilzin, but did not compare Wilzin with any other treatments. The main measure of effectiveness was whether patients had adequate control of copper levels.

What benefit has Wilzin shown during the studies?

Wilzin has been shown to be effective in reducing the absorption of copper and reducing the amount of copper in the body. In the main study, 91% of the patients evaluated (91 out of 100) had adequate control of their copper levels within the first year of treatment with Wilzin.

What is the risk associated with Wilzin?

The most common side effects with Wilzin (seen in between 1 and 10 patients in 100) are gastric irritation (irritation of the stomach) and increased blood levels of enzymes (amylase, lipase and alkaline phosphatase). Gastric irritation is usually worst with the first morning dose and disappears after the first few days of treatment. Delaying the first dose to mid-morning or taking the dose with a small amount of food containing protein, such as meat, may help. For the full list of all side effects reported with Wilzin, see the package leaflet.

Wilzin should not be used in people who may be hypersensitive (allergic) to zinc or any of the other ingredients.

Why has Wilzin been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that Wilson’s disease is a fatal disease and the other medicines already being used for the disease can have severe side effects. Therefore, the Committee decided that Wilzin’s benefits are greater than its risks for the treatment of Wilson’s disease. The Committee recommended that Wilzin be given marketing authorisation.

Other information about Wilzin

The European Commission granted a marketing authorisation valid throughout the European Union for Wilzin to Orphan Europe SARL on 13 October 2004. The marketing authorisation was renewed on 13 October 2009.

Name Language First published Last updated
Wilzin : EPAR - Summary for the public BG = bălgarski 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public ES = español 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public CS = čeština 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public DA = dansk 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public DE = Deutsch 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public ET = eesti keel 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public EL = elliniká 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public EN = English 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public FR = français 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public IT = italiano 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public LV = latviešu valoda 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public LT = lietuvių kalba 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public HU = magyar 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public MT = Malti 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public NL = Nederlands 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public PL = polski 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public PT = português 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public RO = română 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public SK = slovenčina 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public SL = slovenščina 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public FI = suomi 12/09/2006 12/01/2010
Wilzin : EPAR - Summary for the public SV = svenska 12/09/2006 12/01/2010

This EPAR was last updated on 10/09/2013 .

Authorisation details

Product details

Product details for Wilzin
NameWilzin
Agency product numberEMEA/H/C/000535
Active substance

zinc

International non-proprietary name (INN) or common name

zinc

Therapeutic area Hepatolenticular Degeneration
Anatomical therapeutic chemical (ATC) code A16AX05
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Wilzin
Marketing-authorisation holder

Orphan Europe S.A.R.L.

Revision5
Date of issue of marketing authorisation valid throughout the European Union13/10/2004

Contact address:

Orphan Europe S.A.R.L.
Immeuble "Le Wilson"
70, avenue du Général de Gaulle
FR-92800 Puteaux
France

Product information

Product information

17/01/2013  Wilzin -EMEA/H/C/000535 -IB/0010

Name Language First published Last updated
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013
Wilzin : EPAR - Product Information SV = svenska 11/10/2007 10/09/2013

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
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Wilzin : EPAR - All Authorised presentations SV = svenska 21/10/2005  

Pharmacotherapeutic group

Other alimentary-tract and metabolism products

Therapeutic indication

Treatment of Wilson's disease.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Wilzin : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 11/10/2007 10/09/2013

Initial marketing-authorisation documents

Name Language First published Last updated
Wilzin : EPAR - Procedural steps taken before authorisation SV = svenska 21/10/2005  
Wilzin : EPAR - Scientific Discussion SV = svenska 21/10/2005  

Authorised

This medicine is approved for use in the European Union

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