velaglucerase alfa

This medicine is authorised for use in the European Union.


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 08/08/2023

Authorisation details

Product details
Agency product number
Active substance
velaglucerase alfa
International non-proprietary name (INN) or common name
velaglucerase alfa
Therapeutic area (MeSH)
Gaucher Disease
Anatomical therapeutic chemical (ATC) code
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
Takeda Pharmaceuticals International AG Ireland Branch
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Co Dublin
D02 HW68

Product information

25/05/2023 Vpriv - EMEA/H/C/001249 - II/0054

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


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

How useful was this page?

Add your rating