Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: VPRIV   
Auth. number : EU/1/10/646
INN : Velaglucerase alfa
Orphan status based on designation EU/3/10/752 added on 30/08/2010
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: A16AB - Enzymes
Chemical substance: A16AB10 - Velaglucerase alfa
(See WHO ATC Index)
Indication: VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease.
Marketing Authorisation Holder: Shire Pharmaceuticals Ireland Limited
5 River Walk, Citywest Business Campus, Dublin 24, Ireland

  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
30/08/2010 Centralised - Authorisation EMEA/H/C/1249 (2010)6000 of 26/08/2010
09/11/2010 Centralised - Variation EMEA/H/C/1249/IB/1/G
Updated with Decision(2011)4844 of 29/06/2011
14/12/2010 Centralised - Variation EMEA/H/C/1249/IG/29
11/03/2011 Centralised - Variation EMEA/H/C/1249/II/2
07/04/2011 Corrigendum (2010)6000 of 28/06/2010
05/07/2011 Centralised - Variation (2011)4844 of 29/06/2011
28/03/2012 Centralised - Variation EMEA/H/C/1249/II/4 (2012)2178 of 26/03/2012
02/07/2012 Centralised - Variation EMEA/H/C/1249/II/6 (2012)4509 of 27/06/2012
21/12/2012 Centralised - Variation EMEA/H/C/1249/IB/11
Updated with Decision(2013)9850 of 20/12/2013
21/03/2013 Centralised - Variation EMEA/H/C/1249/II/12
Updated with Decision(2013)9850 of 20/12/2013
24/12/2013 Centralised - Variation (2013)9850 of 20/12/2013