This medicine is authorised for use in the European Union.


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 28/08/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Gaucher Disease
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional 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.


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
Sanofi B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Paasheuvelweg 25
1105 BP Amsterdam

Product information

29/06/2023 Cerdelga - EMEA/H/C/003724 - II/0032

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Product information documents contain:

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).

Assessment history

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