Table of contents
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
Yargesa : EPAR - Risk management plan summary (PDF/172.33 KB)
First published: 02/03/2022
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|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
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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.
|Date of issue of marketing authorisation valid throughout the European Union||
17/02/2023 Yargesa - EMEA/H/C/004016 - IB/0012
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
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.