Table of contents
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.
Vpriv : EPAR - Summary for the public (PDF/81.95 KB)
First published: 10/09/2010
Last updated: 01/07/2016
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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.
Takeda Pharmaceuticals International AG Ireland Branch
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Block 2 Miesian Plaza
19/10/2022 Vpriv - EMEA/H/C/001249 - IAIN/0060/G
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Other alimentary tract and metabolism products
Vpriv is indicated for long-term enzyme-replacement therapy (ERT) in patients with type-1 Gaucher disease.