Vpriv

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velaglucerase alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

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

This EPAR was last updated on 07/05/2018

Authorisation details

Product details
Name
Vpriv
Agency product number
EMEA/H/C/001249
Active substance
velaglucerase alfa
International non-proprietary name (INN) or common name
velaglucerase alfa
Therapeutic area (MeSH)
Gaucher Disease
Anatomical therapeutic chemical (ATC) code
A16AB10
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Shire Pharmaceuticals Ireland Ltd 
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
26/08/2010
Contact address
Shire Pharmaceuticals Ireland Ltd
Miesian Plaza Blocks 2 and 3
50-58 Baggot Street Lower
Dublin 2
D02 Y754
Ireland

Product information

16/04/2018 Vpriv - EMEA/H/C/001249 - IAIN/0036/G

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.

Pharmacotherapeutic group

OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS

Therapeutic indication

Vpriv is indicated for long-term enzyme-replacement therapy (ERT) in patients with type-1 Gaucher disease.

Assessment history

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