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 16/09/2022

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
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Publication details
Marketing-authorisation holder
Shire Pharmaceuticals Ireland Ltd 
Revision
18
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

14/09/2022 Vpriv - EMEA/H/C/001249 - N/0058

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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