Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: VPRIV   
Auth. number : EU/1/10/646
Active substance : Velaglucerase alfa
Orphan market exclusivity for "Treatment of Gaucher disease" (based on designation EU/3/10/752) started on 30/08/2010
   10 years of market exclusivity
   2 additional years of market exclusivity as paediatric reward granted on 29/08/2016
   This orphan market exclusivity will expire on 30/08/2022
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 Riverwalk, 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
11/03/2011 Centralised - Variation (no change in Commission Decision) 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
18/12/2013 Centralised - Variation EMEA/H/C/1249/II/15
Updated with Decision(2015)459 of 27/01/2015
24/12/2013 Centralised - Yearly update (2013)9850 of 20/12/2013
29/01/2015 Centralised - Yearly update (2015)459 of 27/01/2015
23/06/2015 Centralised - Renewal EMEA/H/C/1249/R/21 (2015)4303 of 19/06/2015
30/09/2015 Centralised - Variation EMEA/H/C/1249/IAIN/27
Updated with Decision(2016)3700 of 09/06/2016
19/11/2015 Centralised - Variation EMEA/H/C/1249/II/22
Updated with Decision(2016)3700 of 09/06/2016
13/06/2016 Centralised - 2-Monthly update EMEA/H/C/1249/II/29 (2016)3700 of 09/06/2016
29/08/2016 Centralised - 2-Monthly update EMEA/H/C/1249/II/32 (2016)5578 of 25/08/2016
18/10/2016 Rectificative Decision (2016)6777 of 14/10/2016