Cerdelga
eliglustat
Table of contents
Overview
Cerdelga is a medicine used for the long-term treatment of type-1 Gaucher disease in adults.
Gaucher disease is a genetic condition, in which a fat called glucosylceramide (or glucocerebroside) builds up in the body, typically in the liver, spleen and bone. This causes symptoms such as anaemia (low red blood cell counts), tiredness, easy bruising, an enlarged spleen and liver, and bone pain and fractures. The disease is caused by the lack of an enzyme for breaking down fat.
Gaucher disease is rare, and Cerdelga was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 4 December 2007.
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Cerdelga : EPAR - Medicine overview (PDF/77.82 KB)
First published: 13/02/2015
Last updated: 07/08/2018 -
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Cerdelga : EPAR - Risk-management-plan summary (PDF/72.65 KB)
First published: 13/02/2015
Last updated: 13/02/2015
Authorisation details
Product details | |
---|---|
Name |
Cerdelga
|
Agency product number |
EMEA/H/C/003724
|
Active substance |
eliglustat
|
International non-proprietary name (INN) or common name |
eliglustat
|
Therapeutic area (MeSH) |
Gaucher Disease
|
Anatomical therapeutic chemical (ATC) code |
A16AX10
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Orphan |
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. |
Publication details | |
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Marketing-authorisation holder |
Genzyme Europe BV
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
19/01/2015
|
Contact address |
Paasheuvelweg 25 |
Product information
08/11/2021 Cerdelga - EMEA/H/C/003724 - N/0027
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.
Pharmacotherapeutic group
Other alimentary tract and metabolism products
Therapeutic indication
Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).