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 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.
Shire Pharmaceuticals Ireland Ltd
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16/04/2018 Vpriv - EMEA/H/C/001249 - IAIN/0036/G
- 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
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Vpriv is indicated for long-term enzyme-replacement therapy (ERT) in patients with type-1 Gaucher disease.