This is a summary of the European public assessment report (EPAR) for Yargesa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Yargesa.
For practical information about using Yargesa, patients should read the package leaflet or contact their doctor or pharmacist.
Yargesa : EPAR - Summary for the public (PDF/92.75 KB)
First published: 10/04/2017
Last updated: 10/04/2017
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Piramal Critical Care B.V.
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27/01/2020 Yargesa - EMEA/H/C/004016 - IB/0010
- 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.
Other alimentary tract and metabolism products
Yargesa is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.
Yargesa is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.