Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Wilzin   
Auth. number : EU/1/04/286
Active substance : Zinc acetate dihydrate
Orphan status based on designation EU/3/01/050 added on 18/10/2004
10 years of market exclusivity
Orphan status based on designation EU/3/01/050 removed or expired on 19/10/2014
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A16 - Other alimentary tract and metabolism products
Pharmacological subgroup: A16A - Other alimentary tract and metabolism products
Chemical subgroup: A16AX - Various alimentary tract and metabolism products
Chemical substance: A16AX05 - Zinc acetate
(See WHO ATC Index)
Indication: Treatment of Wilson's disease
Marketing Authorisation Holder: Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
18/10/2004 Centralised - Authorisation EMEA/H/C/535 (2004)4056 of 13/10/2004
17/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/535/IA/1
06/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/535/IA/2
26/09/2007 Centralised - Variation EMEA/H/C/535/IA/4
Updated with Decision(2008)1680 of 22/04/2008
24/04/2008 Centralised - Variation (2008)1680 of 22/04/2008
21/10/2009 Centralised - Renewal EMEA/H/C/535/R/5 (2009)8256 of 19/10/2009
03/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/535/IB/7
20/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/535/IB/6
26/01/2012 Centralised - Notification EMEA/H/C/535/N/8
Updated with Decision(2014)566 of 29/01/2014
14/09/2012 Centralised - Notification EMEA/H/C/535/N/9
Updated with Decision(2014)566 of 29/01/2014
17/01/2013 Centralised - Variation EMEA/H/C/535/IB/10
Updated with Decision(2014)566 of 29/01/2014
19/12/2013 Centralised - Variation EMEA/H/C/535/IG/392
Updated with Decision(2014)566 of 29/01/2014
31/01/2014 Centralised - Yearly update (2014)566 of 29/01/2014
19/10/2014 Centralised - (orphan status)