Data from EMC - Curated by Toby Galbraith - Last updated 29 June 2017

Licensing authority

EMA (European Medicines Agency)


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).

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Category Value
Agency product number EMEA/H/C/003724
Orphan designation Yes
Date First Approved 19-01-2015
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Genzyme Europe BV
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions