Cerdelga

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eliglustat

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Cerdelga and why it is authorised in the EU

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.

This EPAR was last updated on 07/08/2018

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
Marketing-authorisation holder
Genzyme Europe BV
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
19/01/2015
Contact address
Gooimer 10
1411 DD Naarden
Netherlands

Product information

07/06/2018 Cerdelga - EMEA/H/C/003724 - II/0015/G

Contents

  • 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.

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).

Assessment history

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